A targeted drug delivery stent and its 3D printing preparation method and application

By using imaging data to distinguish lesions from normal areas in stent implantation technology, and combining 3D printing and computer-assisted modeling technology, targeted drug delivery stents are prepared, which solves the negative impact of drugs on unlesioned areas and significantly improves treatment Effects, suitable for implanted stents of various tumors and ulcers.

CN114948359BActive Publication Date: 2024-12-13NOVAPRINT THERAPEUTICS SUZHOU CO LTD
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Patent Information

Application Number
CN202210723514.4
Authority / Receiving Office
CN · China
Patent Type
Patents(China)
Current Assignee / Owner
Filing Date
2022-06-23
Publication Date
2024-12-13
Estimated Expiration
2042-06-23

AI Technical Summary

Technical Problem

When the existing stent implantation technology treats diseases such as tracheal tumors and esophageal tumors, the drugs are prone to negatively affecting the unleashed area, leading to worsening of the condition, unable to effectively inhibit the lesions, and the treatment effect is not significant.

Method used

Stent model is established through patient image data, and the tissue thickness difference value is used to distinguish the lesion from the normal area. Targeted drug delivery stents are prepared using 3D printing technology. Drug-loading materials are carried in the lesion area, and drug-loading in the normal area is not carried in combination with computer-assisted modeling technology for targeting Cover the drug to ensure targeted treatment of the drug.

Benefits of technology

The drug targeted treatment of lesion areas is achieved to avoid negative impacts on normal areas, significantly improve the treatment effect, inhibit lesions to the greatest extent, and affect normal tissues to the minimum extent. It is suitable for tracheal tumors, esophageal tumors, vascular stenosis, biliary tumors or chronic gastrointestinal Implant stents for intestinal ulcers.

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Abstract

The present invention discloses a targeted drug delivery stent and its 3D printing preparation method and application, and relates to the field of stent technology. The 3D printing preparation method of the targeted drug delivery stent includes: establishing a patient stent model through the development contour of the patient's imaging data; marking the patient stent model through the tissue thickness difference value in the patient's imaging data to distinguish the diseased area from the normal area; preparing the targeted drug delivery stent through one-piece molding or assembly coating, the normal area does not have a drug-loaded material, and the diseased area has a drug-loaded material. The shape and structure of the prepared targeted drug delivery stent better match the narrow channel that the patient needs to expand, which is conducive to subsequent implantation. At the same time, the division of the normal area and the diseased area can ensure that the drug is targeted to treat the diseased area, thereby effectively avoiding the negative impact of the drug on the normal area without the disease, and finally achieving the therapeutic effect of the stent to suppress the disease to the greatest extent and affect the normal tissue to the minimum extent.
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Description

Technical Field

[0001] The present invention relates to the technical field of stents, and in particular to a targeted drug delivery stent and a 3D printing preparation method and application thereof. Background Art

[0002] Stent implantation refers to a technology that uses puncture, catheterization, balloon catheter expansion and metal stent placement to expand and recanalize narrowed, occluded blood vessels or cavities, thereby solving the blind spots of traditional surgery.

[0003] At present, some clinical diseases, such as tracheal tumors, esophageal tumors, chronic gastrointestinal ulcers, etc., often require the implantation of stents to expand the narrow channels caused by the lesions, and at the same time, the stents are covered with drugs to inhibit or treat the symptoms. However, some drugs can cause negative effects in areas without lesions, often leading to further deterioration of the disease and failure to achieve the purpose of treatment.

[0004] In view of this, the present invention is proposed. Summary of the invention

[0005] The purpose of the present invention is to provide a targeted drug delivery stent and a 3D printing preparation method and application thereof.

[0006] The present invention is achieved in that:

[0007] In a first aspect, the present invention provides a 3D printing preparation method for a targeted drug delivery stent, comprising:

[0008] Establishing a patient stent model through the development contour of the patient's imaging data;

[0009] Marking the patient stent model by using the tissue thickness difference value in the patient imaging data to distinguish the diseased area from the normal area;

[0010] The targeted drug delivery stent is prepared by integral molding or assembly coating, wherein the normal area has no drug-loaded material, and the diseased area has drug-loaded material.

[0011] In a second aspect, the present invention provides a targeted drug delivery stent, which is prepared by the 3D printing preparation method of the targeted drug delivery stent as described in any one of the aforementioned embodiments.

[0012] In a third aspect, the present invention provides the use of the targeted drug delivery stent as described in the aforementioned embodiment in the preparation of an implant stent for treating or improving tracheal tumors, esophageal tumors, vascular stenosis, vascular tumors, biliary tumors or chronic gastrointestinal ulcers.

[0013] The present invention has the following beneficial effects:

[0014] The 3D printing preparation method of the targeted drug delivery stent provided in the present application establishes a patient stent model by developing the contour of the patient's imaging data, so that the shape and structure of the stent model are better matched with the narrow channel that the patient needs to expand, which is conducive to subsequent implantation. At the same time, the patient stent model is marked by the difference value of the tissue thickness of the patient's imaging data to distinguish the lesion area from the normal area, and the stent is covered with targeted drugs by computer-aided modeling technology, wherein the lesion area can be loaded with drugs, while the normal area is not loaded with drugs, so as to ensure that the drugs are targeted to treat the lesion area, and then the negative impact of drugs on the normal area without lesions can be effectively avoided, resulting in further deterioration of the disease and failure to achieve the therapeutic effect, and finally achieving the therapeutic effect of the stent to suppress the lesion to the greatest extent and affect the normal tissue to the least extent. The prepared targeted drug delivery stent has a better targeted drug delivery effect and a more significant therapeutic effect, and can be widely used in the preparation of implanted stents for the treatment or improvement of tracheal tumors, esophageal tumors, vascular stenosis, vascular tumors, biliary tumors or chronic gastrointestinal ulcers. BRIEF DESCRIPTION OF THE DRAWINGS

[0015] In order to more clearly illustrate the technical solutions of the embodiments of the present invention, the drawings required for use in the embodiments are briefly introduced below. It should be understood that the following drawings only show certain embodiments of the present invention and therefore should not be regarded as limiting the scope. For ordinary technicians in this field, other related drawings can be obtained based on these drawings without creative work.

[0016] Figure 1 A schematic diagram of image data of stenosis caused by tracheal lesions in a patient provided in Example 1 of the present application;

[0017] Figure 2 A schematic diagram of imaging data of stenosis caused by bile duct lesions in a patient provided in Example 1 of the present application;

[0018] Figure 3 This is a schematic diagram of the three-dimensional model provided in Example 3 of the present application, wherein A is the three-dimensional model confirmed by medical engineers, B is the model with the lesion area and the lesion extension area removed, and C is the actual picture of the assembly mold printed according to B. DETAILED DESCRIPTION

[0019] In order to make the purpose, technical scheme and advantages of the embodiments of the present invention clearer, the technical scheme in the embodiments of the present invention will be described clearly and completely below. If the specific conditions are not specified in the embodiments, they are carried out according to conventional conditions or conditions recommended by the manufacturer. If the manufacturer of the reagents or instruments used is not specified, they are all conventional products that can be purchased commercially.

[0020] The present invention provides a targeted drug delivery stent, and a 3D printing preparation method thereof comprises the following steps:

[0021] S1. Establish a patient stent model through the development contour of the patient's imaging data.

[0022] The patient image data includes at least one of CT data and MRI data. The patient image data can truly reflect the narrowed or occluded blood vessels or cavities of a specific patient, and establishing a patient stent model based on the imaging contour can make the patient stent model more compatible with the patient.

[0023] S2. The patient stent model is marked by the tissue thickness difference value in the patient imaging data to distinguish the diseased area from the normal area.

[0024] When the difference in tissue thickness is 0.5-2mm, it is determined to be a diseased area. The present invention marks the diseased area and normal area of ​​the patient by the tissue thickness of the patient's imaging data, and uses computer-aided modeling technology to perform targeted drug coverage on the stent, ultimately achieving the therapeutic effect of the stent suppressing the lesion to the greatest extent and affecting normal tissue to the minimum extent.

[0025] Preferably, in this application, the lesion area is extended by 2-20% in all directions as the lesion extension area; ensure that the marked area completely covers the lesion, and perform medical confirmation. Since the drug loading situation may be different for different diseases, different drugs and different treatment stages, the specific drug loading of each area is not limited in this application. This application only stipulates that the drug loading of the lesion area is greater than or equal to the drug loading of the lesion extension area; this can maximize targeted treatment. Preferably, the drug loading of the lesion extension area gradually increases along the direction from the normal area to the lesion area.

[0026] S3. A targeted drug delivery stent is prepared by integral molding or assembly coating, wherein the normal area has no drug-loaded material, and the lesion area and the lesion extension area have drug-loaded material.

[0027] In the present application, drugs are covered on the marked lesion areas and lesion extension areas to ensure that the drugs are targeted to treat the lesion areas, while other normal areas are not provided with drugs, thereby effectively avoiding the negative impact of drugs on normal areas without lesions, thereby leading to further deterioration of the disease and failure to achieve the treatment effect.

[0028] Specifically, two preparation methods are provided in the present application, the first is one-piece molding, and the second is assembly coating, both of which can be used to prepare the targeted drug delivery stent of the present application with reference to the normal area, the lesion area and the lesion extension area.

[0029] Next, the two preparation methods will be described in detail.

[0030] The first type: one-piece molding.

[0031] The one-piece molding includes using 3D printing technology to print the main material and the drug-loaded material according to the patient's stent model to prepare a targeted drug delivery stent; the targeted drug delivery stent has a normal area prepared by the printed main material and a lesion area and a lesion extension area prepared by the drug-loaded material.

[0032] One-piece molding is to use 3D printing to directly print different materials layer by layer on the normal area and the lesion area to achieve one-time molding. In the 3D printing process, the drug loading of the drug-loaded material can also be adjusted, so as to achieve partitioned printing of the lesion area and the lesion extension area, which can better control the structure and drug loading of the final targeted drug delivery stent.

[0033] Preferably, the 3D printing technology includes but is not limited to any one of extrusion printing, photocuring printing, microfluidic printing, laser printing, acoustic wave printing, static field spinning or holographic printing.

[0034] Preferably, when 3D printing technology is used to prepare a targeted drug delivery stent, the printing main material includes but is not limited to at least one of a degradable polymer material, a bioceramic material and a biogel material; wherein the degradable polymer material includes but is not limited to at least one of PCL, PLLA, PLA, PLGA and PDX; the bioceramic material includes but is not limited to at least one of hydroxyapatite, tricalcium phosphate, bioglass and bone cement; the biogel material includes but is not limited to at least one of collagen, gelatin, silk fibroin, bacterial cellulose, sodium alginate, fibrinogen and hyaluronic acid; the biogel material also includes a cross-linkable gel material obtained by modifying at least one of collagen, gelatin, silk fibroin, bacterial cellulose, sodium alginate, fibrinogen and hyaluronic acid.

[0035] Preferably, the drug-carrying material used for printing the lesion area and the lesion extension area is prepared by mixing the drug with a carrier material. In the actual printing process, the ratio of the drug to the carrier material can be adjusted to control the drug loading amount. The carrier material includes but is not limited to a biogel material, and the biogel material includes but is not limited to at least one of collagen, gelatin, silk fibroin, bacterial cellulose, sodium alginate, fibrinogen and hyaluronic acid; preferably, the biogel material also includes a cross-linkable gel material obtained by modifying at least one of collagen, gelatin, silk fibroin, bacterial cellulose, sodium alginate, fibrinogen and hyaluronic acid.

[0036] The second type: assembly coating.

[0037] Assembly coating is to first print out the other normal areas except the targeted drug delivery area (i.e., the lesion area and the lesion extension area) as an "assembly mold", and then perform targeted drug coating through the existing stent.

[0038] Specifically, the steps include:

[0039] (1) An assembly mold of a normal area is prepared by using 3D printing technology. The assembly mold includes an inner mold, an outer mold, and a fixing structure for fixing the inner mold and the outer mold. The surfaces of the inner mold and the outer mold both have a lesion cavity for limiting the coating area of ​​the drug-loaded material.

[0040] Printing the assembly mold of the normal area is generally the same as the printing in the first method, but it is worth noting that in the present application, by printing the inner mold and the outer mold separately, the general shape of the inner mold and the outer mold is the same, but the size is slightly different, so as to facilitate subsequent assembly. The printing method of the assembly mold includes but is not limited to at least one of digital light processing technology, stereo printing technology and holographic light forming. Since the assembly mold in the present application needs to be removed later, it is not a stent material directly implanted in the patient's body. Therefore, there is no need to select a degradable material. The printing material of the assembly mold in the present application includes but is not limited to at least one of bio-based epoxy resin, bio-based phenolic resin, bio-based unsaturated polyester resin, bio-based furan resin, oxyacrylate, polyurethane acrylic resin, polyester acrylic resin, amino acrylic resin and photo-imaging alkali-soluble resin.

[0041] (2) The drug-loaded stent is sleeved in the middle of the inner mold, and the inner mold is sleeved in the outer mold through a fixed structure to expose the lesion cavity.

[0042] In the present application, the drug-loaded stent adopts a conventional stent that has been on the market, and the drug-loaded stent includes but is not limited to at least one of a stainless steel stent, a titanium stent, a nickel-chromium alloy stent, a polytetrafluoroethylene stent and a high-density polyethylene stent.

[0043] In the present application, the stent to be loaded with drugs is sleeved on the outer surface of the inner mold, and the inner mold is sleeved in the outer mold through a fixed structure. At this time, the stent to be loaded with drugs is clamped between the inner mold and the outer mold. Since the inner mold and the outer mold have the same lesion cavity, the lesion cavity of the inner mold and the lesion cavity of the outer mold are adjusted to correspond to each other. At this time, except for the position of the lesion cavity, the rest of the area of ​​the stent to be loaded with drugs is tightly clamped by the inner mold and the outer mold, and the drug is not easy to enter this area. Therefore, when loading drugs, the lesion cavity can be loaded in a targeted manner, and targeted coating of the drug can be achieved, thereby achieving the purpose of targeted treatment.

[0044] Preferably, the fixing structure includes a first fixing part arranged on the inner mold and a second fixing part arranged on the outer mold, and the first fixing part and the second fixing part cooperate with each other; the fixing structure has a variety of options, including but not limited to a combination of a slide groove and a slider, a combination of a slot and a buckle, or a positioning pin and a pin hole.

[0045] Among them, when the fixed structure is a combination of a slide groove and a slider, the first fixing member can be a slide groove or a slider, and the second fixing member corresponds to a slider or a slide groove. Similarly, when the fixed structure is a combination of a slot and a buckle, the first fixing member can be a slot or a buckle, and the second fixing member corresponds to a buckle or a slot. When the fixed structure is a combination of a positioning pin and a pin hole, the first fixing member can be a positioning pin or a pin hole, and the second fixing member corresponds to a pin hole or a positioning pin. It should be understood that this application only lists some conventional fixing structures, and other structures can be used as the fixing structure of this application as long as they can achieve the fixing of the inner mold and the outer mold.

[0046] (3) dispersing the drug-loaded material on the surface of the stent to be loaded with the drug corresponding to the lesion cavity;

[0047] The drug-carrying material is prepared by mixing the drug with the carrier material. The drug on the drug-carrying material is not limited in this application. Different drugs and carriers can be selected to mix according to the actual condition to prepare a specific drug-carrying material. The carrier material includes but is not limited to a biogel material, which includes at least one of collagen, gelatin, silk fibroin, bacterial cellulose, sodium alginate, fibrinogen and hyaluronic acid; the biogel material also includes a cross-linkable gel material obtained by modifying at least one of collagen, gelatin, silk fibroin, bacterial cellulose, sodium alginate, fibrinogen and hyaluronic acid.

[0048] Since the drug and carrier materials are different, the applicable loading methods are also different. Therefore, the specific method of dispersing the drug-loaded material on the surface of the stent to be loaded with the drug corresponding to the lesion cavity is not limited in this application. In some embodiments, the method of dispersing the drug-loaded material on the surface of the stent to be loaded with the drug corresponding to the lesion cavity includes but is not limited to conventional methods such as spraying, coating, culturing, injection or soaking. It should be understood that when dispersing the drug-loaded material on the surface of the stent to be loaded with the drug corresponding to the lesion cavity, a cross-linkable material can also be added to the drug-loaded material, and cross-linking after the dispersion is completed can effectively improve the adhesion.

[0049] (4) After drug loading is completed, the assembly mold is removed, and a targeted drug delivery stent is obtained, in which the surface of the stent to be loaded with drugs corresponding to the lesion cavity is coated with drug loading material.

[0050] In addition, it should be noted that when it is necessary to coat the lesion area and the lesion extension area with drug-loaded materials with different drug loading amounts, a partition can also be printed between the lesion area and the lesion extension area when printing and assembling the mold, so as to achieve loading different drug-loaded materials for the lesion area and the lesion extension area respectively.

[0051] The targeted drug delivery stent prepared by the 3D printing preparation method of the targeted drug delivery stent provided by the present application marks the patient's diseased area and normal area through the tissue thickness of the patient's imaging data, and uses computer-aided modeling technology to cover the stent with targeted drugs, thereby ensuring that the drug is targeted to treat the diseased area, while other normal areas are not set with drugs, thereby effectively avoiding the negative impact of drugs on normal areas without disease, which in turn leads to further deterioration of the disease and failure to achieve the treatment effect, and ultimately achieves the therapeutic effect of the stent to maximally inhibit the disease and minimize the impact on normal tissues.

[0052] Furthermore, in the process of integral molding or assembly coating of the present application, different therapeutic effects can be achieved by controlling the drug loading in the lesion area and the lesion extension area. In the present application, by changing the drug loading in the lesion area and the lesion extension area, the drug content and release characteristics in the lesion area and the lesion extension area can be regulated, and finally the strength of reasonable medication can be selected for different conditions (acute stage, subacute stage, chronic infection).

[0053] The targeted drug delivery stent provided in the present application can be widely used in the preparation of implantable stents for treating or improving tracheal tumors, esophageal tumors, vascular stenosis, vascular tumors, biliary tumors or chronic gastrointestinal ulcers, etc.

[0054] The features and performance of the present invention are further described in detail below in conjunction with the embodiments.

[0055] Example 1

[0056] This embodiment provides a targeted drug delivery stent for treating tracheal and bile duct stenosis, and the preparation method thereof comprises the following steps:

[0057] S1. Establishing a patient stent model through the development contour of the patient's imaging data;

[0058] S2. At the same time, the patient stent model is marked by the difference value of tissue thickness in the patient imaging data to distinguish the lesion area from the normal area; the lesion area is extended by 10% in each direction as the lesion extension area; Figure 1 and Figure 2 As shown, the gray area is the lesion area QY1, the white extension area is the lesion extension area QY2, and the dark gray area is the normal tissue area QY3.

[0059] S3. Use 3D extrusion printing technology to print the main material and the drug-loaded material according to the patient stent model to prepare a targeted drug delivery stent; wherein the main printing material and the drug-loaded material are both biogel materials (bacterial cellulose), and the main printing material is not loaded with drugs.

[0060] Example 2

[0061] This embodiment is basically the same as Embodiment 1, except that the lesion extension area in Embodiment 1 is omitted.

[0062] Example 3

[0063] This embodiment provides another targeted drug delivery stent for treating tracheal and bile duct stenosis, and the preparation method thereof comprises the following steps:

[0064] S1. Establishing a patient stent model through the development contour of the patient's imaging data;

[0065] S2. At the same time, the patient stent model is marked by the difference value of tissue thickness in the patient's imaging data to distinguish the lesion area from the normal area; the lesion area is extended by 10% in each direction as the lesion extension area to ensure that the marked area completely covers the lesion, and medical confirmation is performed, such as Figure 3 A in the middle is a 3D model of a patient case confirmed by medical engineers. The light color is the normal area, and the dark color is the lesion area and the lesion extension area. Figure 3 Middle B is the model with the lesion area and the lesion extension area removed.

[0066] S3. Use 3D printing technology to print the normal area of ​​the bio-based resin according to the patient stent model as an assembly mold, such as Figure 3 As shown in C, it is a physical picture of the assembled mold printed according to B; the number of prints is 2, namely the inner mold and the outer mold, the size of the outer mold is slightly larger than the size of the inner mold, and the surfaces of the inner mold and the outer mold have a lesion cavity (including the lesion area and the lesion extension area) for limiting the drug-loaded material coating area;

[0067] S4, sleeve the drug-loaded stent on the outer surface of the inner mold, and sleeve the inner mold inside the outer mold through a fixed structure to expose the lesion cavity;

[0068] S5, coating 50% paclitaxel-vinyl acetate copolymer (EVA) drug-loaded material on the surface of the stent to be loaded with drugs corresponding to the lesion cavity;

[0069] S6. After the drug loading is completed, the assembly mold is removed, and a targeted drug delivery stent is obtained, in which the surface of the stent to be loaded with drugs corresponding to the lesion cavity is coated with drug loading material.

[0070] Example 4

[0071] This embodiment is basically the same as the embodiment 3, except that, when printing the assembly mold in step S3, the lesion cavity of the assembly mold is divided into zones, wherein the inner circle is the lesion area and the outer circle is the extended lesion area. In the coating process of step S5, drug-loaded materials with different drug loading amounts are coated on the lesion area and the extended lesion area, respectively, wherein the drug loading amount of the lesion area is greater than that of the extended lesion area.

[0072] Comparative Example 1

[0073] In this comparative example, 3D printing technology is directly used to prepare a printed stent from a biogel material (bacterial cellulose) that is not loaded with drugs according to a non-partitioned patient stent model, and then the stent is immersed in a drug solution to load the drug.

[0074] Comparative Example 2

[0075] In this comparative example, 3D printing technology is directly used to prepare and print titanium alloy powder according to a non-partitioned patient stent model to form a porous stent with a porosity of 70%, and then the porous stent is immersed in a drug-loaded biogel material to load the drug.

[0076] Test example

[0077] The drug-loaded stents obtained in the above Examples 1-4 and Comparative Examples 1-2 were implanted into porcine tracheal tumors, and a control group (without stent) was set up. After 120 days, the stents and surrounding tumors / tissues were removed, and hard tissue sections and H&E staining were performed. Respiratory specialists were asked to review the sections blindly and score the severity of the tumor and the abnormal conditions of the surrounding tissues. The evaluation results are shown in the following table.

[0078] Tumor severity Abnormality of surrounding tissue No stent ++ + Comparative Example 1 -- ++ Comparative Example 2 -- ++ Example 1 -- - Example 2 - - Example 3 -- - Example 4 -- --

[0079] Note: “++” indicates that the degree of tumor / tissue abnormality is significantly aggravated, “+” indicates that the degree of tumor / tissue abnormality is slightly aggravated, “--” indicates that the degree of tumor / tissue abnormality is significantly reduced, and “-” indicates that the degree of tumor / tissue abnormality is slightly reduced.

[0080] In summary, the 3D printing preparation method of the targeted drug delivery stent provided in the present application establishes a patient stent model by developing the contour of the patient's imaging data, so that the shape and structure of the stent model are better matched with the narrow channel that the patient needs to expand, which is conducive to subsequent implantation. At the same time, the patient stent model is marked by the difference value of the tissue thickness of the patient's imaging data to distinguish the lesion area from the normal area, and the stent is covered with targeted drugs using computer-aided modeling technology, wherein the lesion area can be loaded with drugs, while the normal area is not loaded with drugs, ensuring that the drugs are targeted to treat the lesion area, and then the negative impact of drugs on the normal area without lesions can be effectively avoided, which leads to further deterioration of the disease and the inability to achieve the therapeutic effect, and finally achieves the therapeutic effect of the stent to suppress the lesion to the greatest extent and affect the normal tissue to the minimum extent. The prepared targeted drug delivery stent has a better targeted drug delivery effect and a more significant therapeutic effect, and can be widely used in the preparation of implanted stents for the treatment or improvement of tracheal tumors, esophageal tumors, vascular tumors or chronic gastrointestinal ulcers.

[0081] The above description is only a preferred embodiment of the present invention and is not intended to limit the present invention. For those skilled in the art, the present invention may have various modifications and variations. Any modification, equivalent replacement, improvement, etc. made within the spirit and principle of the present invention shall be included in the protection scope of the present invention.

Claims

1. A 3D printing preparation method for a targeted drug delivery stent, characterized in that: It includes: Establishing a patient stent model through the development contour of the patient's imaging data; Marking the patient stent model by using the tissue thickness difference value in the patient imaging data to distinguish the diseased area from the normal area; The targeted drug delivery stent is prepared by assembling and coating, wherein the normal area has no drug-loaded material, and the diseased area has the drug-loaded material; The assembly coating comprises: The assembly mold of the normal area is prepared by 3D printing technology, and the assembly mold includes an inner mold, an outer mold, and a fixing structure for fixing the inner mold and the outer mold, and the surfaces of the inner mold and the outer mold both have a lesion cavity for defining the drug-loaded material coating area; The drug-loaded stent is sleeved in the middle of the inner mold, and the inner mold is sleeved in the outer mold through the fixing structure to expose the lesion cavity; Dispersing the drug-loaded material on the surface of the stent to be loaded with drugs corresponding to the lesion cavity; After the drug loading is completed, the assembly mold is removed, and a targeted drug delivery stent is obtained in which the surface of the stent to be loaded with drugs corresponding to the lesion cavity is coated with the drug loading material.

2. The 3D printing preparation method of the targeted drug delivery stent according to claim 1, characterized in that: The patient image data includes at least one of CT data and MRI data.

3. The 3D printing preparation method of the targeted drug delivery stent according to claim 1, characterized in that: When the tissue thickness difference value is 0.5-2 mm, it is determined to be the lesion area.

4. The 3D printing preparation method of the targeted drug delivery stent according to claim 1, characterized in that: The lesion area was extended by 2-20% in all directions as the lesion extension area.

5. The 3D printing preparation method of the targeted drug delivery stent according to claim 1, characterized in that: The drug loading amount in the lesion area is greater than or equal to the drug loading amount in the lesion extension area.

6. The 3D printing preparation method of the targeted drug delivery stent according to claim 1, characterized in that: The drug loading amount of the lesion extension area gradually increases along the normal area toward the lesion area.

7. The 3D printing preparation method of the targeted drug delivery stent according to claim 1, characterized in that: The fixing structure includes a first fixing member arranged on the inner mold and a second fixing member arranged on the outer mold, and the first fixing member and the second fixing member cooperate with each other.

8. The 3D printing preparation method of the targeted drug delivery stent according to claim 7, characterized in that: The fixing structure includes any one of a sliding groove and a sliding block, a clamping groove and a buckle, a positioning pin and a pin hole.

9. The 3D printing preparation method of the targeted drug delivery stent according to claim 1, characterized in that: Dispersing the drug-loaded material on the surface of the stent to be loaded with drug corresponding to the lesion cavity includes: dispersing the drug-loaded material on the surface of the stent to be loaded with drug corresponding to the lesion cavity by spraying, coating, culturing, injecting or soaking.

10. The 3D printing preparation method of the targeted drug delivery stent according to claim 1, characterized in that: The drug-loaded stent includes at least one of a stainless steel stent, a titanium stent, a nickel-chromium alloy stent, a polytetrafluoroethylene stent and a high-density polyethylene stent.

11. A targeted drug delivery stent, characterized in that: It is prepared by the 3D printing preparation method of the targeted drug delivery stent as described in any one of claims 1 to 10.

12. Use of the targeted drug delivery stent according to claim 11 in preparing an implant stent for treating or improving tracheal tumors, esophageal tumors, vascular stenosis, vascular tumors, biliary tumors or chronic gastrointestinal ulcers.