Mechanically balanced microneedle for keloid, preparation method and application of microneedle in preparation of product for preventing relapse of keloid

Abstract

The invention relates to a keloid mechanical equilibrium microneedle, a preparation method and application in preparation of a product for preventing relapse of keloid, and the preparation method of the keloid mechanical equilibrium microneedle comprises the following steps: firstly, constructing a preliminary skin-scar finite element model consisting of a scar structure and a skin structure according to the average thickness of a postoperative scar tissue of an object; the thicknesses of all positions of the whole scar structure are the same; and finally obtaining the keloid mechanical equilibrium microneedle through four steps. The keloid mechanical equilibrium microneedle is prepared in a personalized mode according to postoperative scar tissue of an object, stress between the keloid and surrounding skin can be evenly distributed through the keloid mechanical equilibrium microneedle, and relapse of the keloid is effectively prevented.

Description

Technical Field

[0001] The present invention relates to the field of medical technology, and in particular to a keloid mechanical balance microneedle, a preparation method and use thereof in preparing a product for preventing keloid recurrence. Background Art

[0002] Keloid is a fibrotic disease caused by excessive deposition of collagen in the dermis after skin injury, and is characterized by a high recurrence rate. Currently, the treatments for keloid are divided into surgical intervention and drug therapy, including combined drug administration methods such as injection, radiotherapy, laser, and cryotherapy. Studies have shown that no matter what treatment method is used, the recurrence rate of keloid can be as high as 28%-70%. Keloids that are difficult to cure are often accompanied by pain, itching and ulceration, and may even cause functional disorders in the human body, seriously affecting the patient's physical and mental health.

[0003] The imbalance of the mechanical environment between keloids and adjacent skin is the main factor leading to the recurrence of keloids. However, existing treatments often cause excessive or uneven degradation of collagen in scars, further aggravating the imbalance of the mechanical environment. Microneedle arrays (MNA), as a simple, minimally invasive, and painless drug delivery strategy, have been widely studied in the field of skin-related diseases. Current studies have shown that microneedle arrays have the function of uniformly regulating skin tissue stress and improving the mechanical environment. However, the current preparation of microneedles mainly uses materials to regulate skin tissue stress and improve the mechanical environment, and ignores the changes in mechanical properties between postoperative keloids and the skin they pull.

[0004] Therefore, in view of the shortcomings of the existing technology, it is necessary to provide a keloid mechanical balance microneedle, a preparation method and use in the preparation of a product for preventing keloid recurrence to solve the shortcomings of the existing technology. Summary of the invention

[0005] The first object of the present invention is to avoid the shortcomings of the prior art and provide a method for preparing a mechanically balanced microneedle for keloid. The method for preparing a mechanically balanced microneedle for keloid can obtain a personalized mechanically balanced microneedle for keloid, and the prepared mechanically balanced microneedle for keloid can make the stress distribution between the keloid and the surrounding skin uniform.

[0006] The above-mentioned purpose of the present invention is achieved by the following technical measures:

[0007] Provided is a method for preparing a keloid mechanical balance microneedle, comprising the following steps:

[0008] S1. According to the average thickness A of the postoperative scar tissue of the subject, a preliminary skin-scar finite element model consisting of scar structure and skin structure is constructed, and the difference between the maximum thickness and the minimum thickness in the scar tissue is defined as H, and 0≤H≤0.2mm exists;

[0009] S2, fixing the scar structure edge and the skin structure in the preliminary skin-scar finite element model obtained in S1 to obtain a skin-scar finite element model;

[0010] S3, constructing a plurality of microneedle array models with different microneedle parameters, wherein the microneedle array model is provided with a base and needle bodies distributed in an array, and the needle bodies are arranged on the base;

[0011] S4, inserting the needle bodies of each microneedle array model obtained in S3 into the scar structure of the skin-scar finite element model obtained in S2, respectively, to obtain a plurality of corresponding stress distribution maps, and then screening out the stress distribution map with the smallest mechanical difference between the edge of the scar structure and the skin structure from among all the stress distribution maps, and the microneedle array model corresponding to the stress distribution map with the smallest mechanical difference is taken as the optimal microneedle array model;

[0012] S5. Produce the optimal microneedle array model obtained in S4 to obtain the keloid mechanical balance microneedle.

[0013] Preferably, the above S1 is obtained by the following steps:

[0014] S1.1. Obtain the average thickness A of the scar tissue after surgery;

[0015] S3.2, the average thickness A of S1.1 is used as the thickness of the scar structure, and the shape of the scar structure is a long strip;

[0016] S3.3. Embed the scar structure obtained in S3.2 into the skin structure, and the thickness of the skin structure is h, and 0mm<h≤5.0mm, to obtain the preliminary skin-scar finite element model.

[0017] Preferably, the above S2 is obtained by the following steps:

[0018] S2.1, meshing the preliminary skin-scar finite element model obtained in S1, and proceeding to S2.2;

[0019] S2.2. Fix the edge of the scar structure and the skin structure, set the strain on both sides of the skin structure to Y, and 0%<Y≤10%, to obtain the skin-scar finite element model.

[0020] Preferably, the above-mentioned microneedle parameters are the diameter D of the needle body, the height G of the needle body and the distance L between the needle body and the adjacent needle body.

[0021] Preferably, the preliminary skin-scar finite element model, the skin-scar finite element model and the microneedle array model are all constructed in Soildwork software.

[0022] Preferably, the above S2.1 specifically imports the preliminary skin-scar finite element model obtained in S1 into Hypermesh software for meshing.

[0023] In S2.2, the edge of the scar structure is fixed to the skin structure by using a rigids function.

[0024] Preferably, the above h is 2 mm; and the above Y is 4%.

[0025] The second purpose of the present invention is to avoid the shortcomings of the prior art and provide a keloid mechanical balance microneedle that can make the stress distribution between the keloid and the surrounding skin uniform.

[0026] The above-mentioned purpose of the present invention is achieved by the following technical measures:

[0027] Provided is a keloid mechanically balanced microneedle, which is prepared by the above-mentioned keloid mechanically balanced microneedle preparation method.

[0028] The third object of the present invention is to avoid the shortcomings of the prior art and provide a use of a keloid mechanical balance microneedle in preparing a product for preventing keloid recurrence. The keloid mechanical balance microneedle can make the stress distribution between the keloid and the surrounding skin uniform, thereby preventing the recurrence of the keloid.

[0029] The above-mentioned purpose of the present invention is achieved by the following technical measures:

[0030] Provided is a use of the keloid mechanical balance microneedle in preparing a product for preventing keloid recurrence.

[0031] The present invention discloses a keloid mechanical balance microneedle, a preparation method and use thereof in preparing a product for preventing keloid recurrence, wherein the preparation method of the keloid mechanical balance microneedle comprises the following steps: S1, constructing a preliminary skin-scar finite element model consisting of a scar structure and a skin structure according to the average thickness A of the scar tissue after surgery of the subject, and defining the difference between the maximum thickness and the minimum thickness in the scar tissue as H, and there is 0≤H≤0.2mm; S2, fixing the scar structure edge and the skin structure in the preliminary skin-scar finite element model obtained in S1 to obtain a skin-scar finite element model; S3, constructing a plurality of microneedles with different microstructures; A microneedle array model with needle parameters, the microneedle array model is provided with a base and a needle body distributed in an array, and the needle body is arranged on the base; S4, the needle bodies of each microneedle array model obtained in S3 are correspondingly inserted into the scar structure of the skin-scar finite element model obtained in S2, and a plurality of stress distribution maps are obtained accordingly, and then the stress distribution map with the smallest mechanical difference between the edge of the scar structure and the skin structure is screened out from all the stress distribution maps, and the microneedle array model corresponding to the stress distribution map with the smallest mechanical difference is used as the best microneedle array model; S5, according to the best microneedle array model obtained in S4, the mechanical balance microneedle of keloid is obtained. The mechanical balance microneedle of keloid of the present invention is prepared in an individualized manner according to the postoperative scar tissue of the object, and the stress distribution between the keloid and the surrounding skin can be uniformly distributed through the mechanical balance microneedle of keloid, effectively preventing the recurrence of keloid. BRIEF DESCRIPTION OF THE DRAWINGS

[0032] The present invention is further described with reference to the accompanying drawings, but the contents in the accompanying drawings do not constitute any limitation to the present invention.

[0033] Figure 1 This is a picture of the scar tissue after surgery.

[0034] Figure 2 This is a B-ultrasound image of the scar tissue after surgery.

[0035] Figure 3 This is an ultrasound image of scar tissue of another subject after surgery.

[0036] Figure 4 Schematic diagram of scar structure and skin structure.

[0037] Figure 5 This is a schematic diagram of the scar structure embedded in the skin structure.

[0038] Figure 6 for Figure 5 Schematic diagram from another angle.

[0039] Figure 7 Schematic diagram of the microneedle array model.

[0040] Figure 8 This is the stress distribution diagram of the skin-scar finite element model after skin stretching.

[0041] Fig. 9 Schematic diagram of the microneedle array model after insertion into the skin-scar finite element model.

[0042] Fig.10 It is the stress distribution diagram.

[0043] Fig.11 It is the stress distribution diagram.

[0044] Fig.12 Schematic diagram of the mechanical balance of keloid microneedles during use.

[0045] Fig.13 This is a picture of the patient's scar tissue before surgery.

[0046] Fig.14 This is a picture of scar tissue after trephination surgery.

[0047] Fig.15 Schematic diagram of simulating skin-scar segmentation data.

[0048] Fig.16 for Fig.15 Schematic diagram from another angle.

[0049] Fig.17 Schematic diagram of the finite element model for simulating skin-scar.

[0050] Fig.18 Schematic diagram of scar structure in the preoperative finite element model.

[0051] Fig.19 Schematic diagram of scar structure in the finite element model after trephination.

[0052] Fig. 20 Schematic diagram of scar structure in the segmentation finite element model.

[0053] Fig.21 Mechanical characteristics diagram of the skin-scar finite element model when the skin is stretched to 10%.

[0054] Fig. 22 This is the mechanical characteristics diagram of the preoperative finite element model when the skin is stretched to 10%.

[0055] Fig.23 This is a diagram simulating the stress distribution of the skin-scar finite element model when the skin is stretched to 10%.

[0056] Fig.24 This is a diagram showing the stress distribution of the preoperative finite element model when the skin is stretched to 10%.

[0057] Fig.25 This is a diagram showing the stress distribution of the finite element model after trephination when the skin is stretched to 10%.

[0058] Fig.26 This is a diagram of the stress distribution of the segmentation finite element model when the skin is stretched to 10%.

[0059] exist Figures 4 to 7 Including:

[0060] Scar structure 100 , skin structure 300 , microneedle 300 , needle body 310 , base 320 . DETAILED DESCRIPTION

[0061] The technical solution of the present invention is further described in conjunction with the following embodiments.

[0062] Example 1

[0063] A method for preparing a keloid mechanical balance microneedle comprises the following steps:

[0064] S1. According to the average thickness A of the postoperative scar tissue of the subject, a preliminary skin-scar finite element model consisting of scar structure and skin structure is constructed, and the difference between the maximum thickness and the minimum thickness in the scar tissue is defined as H, and there exists 0≤H≤0.2mm; wherein S1 is obtained by the following steps:

[0065] S1.1. Obtain postoperative scar tissue from the subject (e.g. Figure 1-Figure 3 ) has an average thickness A, where Figure 2 for Figure 1 The corresponding B-ultrasound image, Figure 3 This is an ultrasound image of scar tissue after surgery of another subject. Figure 2 The middle arrow indicates scar tissue; Figure 2 The H in is 0.2mm, Figure 3 The H in the figure is 0 mm, and the present invention is applicable only when the H of the postoperative scar tissue of the subject is within the range of 0 mm to 0.2 mm;

[0066] S3.2, based on the average of the scar tissues in S1.1, the scar structure is obtained, such as Figure 4 , and the scar structure is in the shape of a long strip;

[0067] S3.3. The scar structure obtained in S3.2 is embedded into the skin structure, and the thickness of the skin structure is h, and 0mm<h≤5.0mm, h is specifically 2mm, to obtain a preliminary skin-scar finite element model.

[0068] S2, fixing the scar structure edge and the skin structure in the preliminary skin-scar finite element model obtained in S1 to obtain a skin-scar finite element model; S2 is specifically obtained by the following steps:

[0069] S2.1, import the preliminary skin-scar finite element model obtained in S1 into Hypermesh software for meshing, and proceed to S2.2;

[0070] S2.2, fix the scar structure edge and skin structure by using the rigids function, such as Figure 5 and Figure 6 , the strain on both sides of the skin structure is set to Y, there is 0%<Y≤10%, Y is specifically 4%, and the skin-scar finite element model is obtained, such as Figure 8 ,in Figure 8 It is the top view of the skin-scar finite element model;

[0071] S3, constructing a plurality of microneedle array models with different microneedle parameters, wherein the microneedle array model is provided with a base and needle bodies distributed in an array, such as Figure 7 , the needle body is arranged on the base, wherein the microneedle parameters are the diameter D of the needle body, the height G of the needle body and the distance L between the needle body and the adjacent needle body;

[0072] S4, inserting the needle bodies of each microneedle array model obtained in S3 into the scar structure of the skin-scar finite element model obtained in S2, such as Fig. 9 , corresponding to multiple stress distribution diagrams, such as Fig.10 and Fig.11 Then, among all stress distribution maps, the stress distribution map with the smallest mechanical difference between the scar structure edge and the skin structure is screened out, and the microneedle array model corresponding to the stress distribution map with the smallest mechanical difference is taken as the optimal microneedle array model;

[0073] S5. According to the optimal microneedle array model obtained in S4, a mechanically balanced microneedle for keloid is obtained, such as by 3D printing or molding.

[0074] It should be noted that the keloid mechanical balance microneedle of the present invention is generally suitable for scar tissue after surgery with an average thickness A within the range of 0.2 mm to 1.0 mm.

[0075] In S1 of the present invention, the scar tissue after surgery is uniformly thick, that is, the scar tissue is the same or substantially the same in thickness, and substantially the same means that the difference between the maximum thickness and the minimum thickness in the scar tissue is within the range of 0 to 0.2 mm or 0 to 0.1 mm. The thickness of the scar tissue after surgery is obtained by B-ultrasound or CT. The applicant has clinically analyzed that when the scar tissue is uniformly thick, the scar tissue is consistent with the chest contour, and in this state, the stress distribution of the scar tissue and the surrounding skin is uniform, which is conducive to preventing the recurrence of keloids. Then, the keloid mechanical balance microneedle of the present invention is used to further disperse the stress distribution between the scar tissue and the skin tissue, thereby effectively preventing the recurrence of keloids.

[0076] The preliminary skin-scar finite element model, the skin-scar finite element model, and the microneedle array model of the present invention are all constructed in Soildwork software.

[0077] The present invention sets a plurality of microneedle array models with different microneedle parameters in S3, for example, the diameter of the needle body, the height of the needle body, and the spacing between the needle body and the adjacent needle body are all taken as three values. The microneedle parameters are based on references and commonly used microneedle structures on the market. The diameter D of this embodiment can be 0.2mm, 0.4mm, and 0.6mm, etc., the height G can be 0.6mm, 0.8mm, and 1.0mm, etc., and the spacing L can be 0.8mm, 1.0mm, and 1.2mm, etc. When the diameter D, height G, and spacing L are, there should be 27 microneedle array models, and the needle bodies of the 27 microneedle array models are respectively inserted into the skin-scar finite element model, and 27 corresponding stress distribution diagrams are obtained. Of course, the data volume of the diameter of the needle body, the height of the needle body, and the spacing between the needle body and the adjacent needle body can also be other, depending on the actual situation. It should be noted that, since the thickness of each position of the entire scar structure in the skin-scar finite element model of the present invention is the same, the diameter of the needle body, the height of the needle body and the spacing between the needle bodies and adjacent needle bodies in the microneedle array model are all the same.

[0078] In S4, the present invention inserts the needle bodies of the microneedle array model into the scar structure of the skin-scar finite element model respectively to obtain multiple stress distribution diagrams after the needle bodies are inserted, and then compares the mechanical differences between the scar structure edge and the skin structure in each stress distribution diagram, and selects the microneedle array model corresponding to the stress distribution diagram with the smallest mechanical difference as the optimal microneedle array model.

[0079] The mechanical difference between the scar structure edge and the skin structure of the present invention, such as Figure 8 The stress distribution diagram of the stress distribution, in Figure 8 The scar structure is the red stress area, and the others are skin structures. Figure 8 It can be seen that there is a significant difference in stress between scar structure and skin structure. Fig.10 and Fig.11 In the experiment, when the needles of different microneedle array models were inserted into the scar structure of the skin-scar finite element model, the stress in the scar structure was significantly reduced. Fig.11 It can be seen that when the corresponding microneedle array model is inserted into the skin-scar finite element model, the stress difference between the scar structure and the skin structure is significantly less than Fig.10 . Therefore, Fig.10 compared to, Fig.11 The stress distribution diagram with the smallest mechanical difference between the scar structure edge and the skin structure has the most uniform stress distribution. Fig.11 The corresponding microneedle array model can be used as the optimal microneedle array model.

[0080] It should be noted that, in S5 of the present invention, the microneedle array model can also be flipped into the contour of the scar tissue according to the contour of the postoperative scar tissue of the object, and then made into a mechanically balanced microneedle for keloid. A deformable material can also be selected as the raw material of the mechanically balanced microneedle for keloid, and the mechanically balanced microneedle for keloid can be used by flipping the needle from the base. The operation process of flipping the microneedle array model into the contour of the scar tissue is to use the "Curve" tool in the FreeForm software to create a curve consistent with the curvature of the chest of the object, select the Tug with Curve function, then click the curve, then click the microneedle entity, and click Execute to obtain a microneedle array model consistent with the chest curve.

[0081] The method for preparing the keloid mechanical balance microneedle prepares personalized keloid mechanical balance microneedle based on the thickness of the scar tissue after surgery of the subject. The keloid mechanical balance microneedle can make the stress distribution between the keloid and the surrounding skin uniform, and effectively prevent the recurrence of the keloid.

[0082] Example 2

[0083] A keloid mechanical balance microneedle is prepared by using the preparation method of the keloid mechanical balance microneedle of Example 1.

[0084] It should be noted that the interior of the keloid mechanical balance microneedle of the present invention may also be loaded with active drugs.

[0085] The material of the keloid mechanical balance microneedle is a deformable material, because when in use, the base can be flipped to be the same as the contour of the scar tissue and inserted into the scar tissue, such as Fig.12 .

[0086] The keloid mechanical balance microneedle can evenly distribute the stress between the keloid and the surrounding skin, effectively preventing the recurrence of the keloid.

[0087] Example 3

[0088] A use of a keloid mechanical balance microneedle in preparing a product for preventing keloid recurrence.

[0089] The keloid mechanical balance microneedle of the present invention can make the stress distribution between the keloid and the surrounding skin uniform, thereby preventing the recurrence of the keloid.

[0090] Verification Example

[0091] The stress conditions of scar tissue and skin groups before and after surgery were analyzed through the following steps. It was found that the stress distribution of scar tissue and surrounding skin was most uniform when the scar tissue was of uniform thickness. The data of patients with chest scars were used as an example to illustrate:

[0092] Step 1: Obtain the patient's preoperative ( Fig.13 ) and postoperative data of trephination ( Fig.14 )’s post-trephination data;

[0093] Step 2: Use Mimics software to segment the skin structure and scar structure in the preoperative data and post-trephination data, respectively, and obtain the preoperative segmentation data and the pre-trephination segmentation data; at the same time, use the Tied option to project the bottom surface of the scar structure to the skin structure in the preoperative segmentation data, such as Fig.15 and Fig.16 , obtaining simulated skin-scar segmentation data composed of skin structure and scar structure projection, in which the partial structure of the scar bottom surface projection area is used as the scar structure of the data, and the scar structure of the data matches the patient's thorax, and the scar structure and skin structure of the data are in a uniform thickness state;

[0094] Step 3, the simulated skin-scar segmentation data corresponds to the simulated skin-scar model in STL format, the preoperative segmentation data corresponds to the preoperative model in STL format, and the postoperative segmentation data after trephination corresponds to the postoperative model after trephination in STL format;

[0095] Step 3: Import the simulated skin-scar model, preoperative model and post-trephine model into Geomagic Wrap software respectively, and select the command: Accurate Surface - Automatic Surfacing - Construct Contour Line - Construct Surface Patch - Construct Grid - Fit Surface, and finally generate Nurbs surface, export and save it in IGES format;

[0096] Step 3: Import the three IGES formats into HyperMesh14.0 software to establish the corresponding simulated skin-scar finite element model ( Fig.17 )、Preoperative finite element model ( Fig.18 ), finite element model after trephination ( Fig.19 ); In order to analyze the stress of different surgical procedures, another surgical procedure, scar segmentation, was simulated in the preoperative finite element model to process the scar structure, and the corresponding segmentation finite element model was obtained ( Fig. 20 ); The material properties of the skin structure and scar structure are set in these four finite element models, as shown in Table 1;

[0097] Table 1. Material properties of skin structure and scar structure in finite element model

[0098]

[0099] Step 4: The skin in the four finite element models is stretched within a range of 0% to 10%. Specifically, the skin in the finite element model is divided into upper, lower, left, and right sides, and the left and right sides are stretched. Fig.21 and Fig. 22 ;

[0100] Step 5. In each finite element model, two points are taken, the first point is the point corresponding to the position in the keloid area; the second point is the point corresponding to the position in the skin area; and the positions of the two nodes are the same in each finite element model, wherein Table 2 is the pressure distribution pressure value of the finite element model corresponding to 10% stretching, such as Figure 23 to Figure 26 ;

[0101] Table 2. Pressure values ​​of two points in different finite element models

[0102] Finite element model First point pressure (Mpa) Second point (Mpa) Simulated Skin-Scar Finite Element Model 0.086 0.082 Preoperative finite element model 0.257 0.105 Trepanation Finite Element Model 0.452 0.151 Segmentation finite element model 0.071 0.027

[0103] The results show that the difference between the two points in the simulated skin-scar finite element model is the smallest, which is 0.004Mpa. Therefore, the stress distribution of the simulated skin-scar finite element model is the most uniform. Therefore, it is believed that the stress distribution is the most uniform when the keloid morphology is restored to the chest morphology during surgery, that is, the keloid is of uniform thickness. Since the scar structure in the preoperative scar finite element model, the trephination finite element model, and the segmentation finite element model is a non-uniform thickness structure, the stress distribution between the scar and the skin is uneven.

[0104] Finally, it should be noted that the above embodiments are only used to illustrate the technical solution of the present invention rather than to limit the scope of protection of the present invention. Although the present invention has been described in detail with reference to the preferred embodiments, those skilled in the art should understand that the technical solution of the present invention can be modified or replaced by equivalents without departing from the essence and scope of the technical solution of the present invention.

Claims

1. A method for preparing a keloid mechanical balance microneedle, characterized in that: The following steps are performed: S1. According to the average thickness A of the postoperative scar tissue of the subject, a preliminary skin-scar finite element model consisting of scar structure and skin structure is constructed, and the difference between the maximum thickness and the minimum thickness in the scar tissue is defined as H, and 0≤H≤0.2mm exists; S2, fixing the scar structure edge and the skin structure in the preliminary skin-scar finite element model obtained in S1 to obtain a skin-scar finite element model; S3, constructing a plurality of microneedle array models with different microneedle parameters, wherein the microneedle array model is provided with a base and needle bodies distributed in an array, and the needle bodies are arranged on the base; S4, inserting the needle bodies of each microneedle array model obtained in S3 into the scar structure of the skin-scar finite element model obtained in S2, respectively, to obtain a plurality of corresponding stress distribution maps, and then screening out the stress distribution map with the smallest mechanical difference between the edge of the scar structure and the skin structure from among all the stress distribution maps, and the microneedle array model corresponding to the stress distribution map with the smallest mechanical difference is taken as the optimal microneedle array model; S5. Produce the optimal microneedle array model obtained in S4 to obtain the keloid mechanical balance microneedle.

2. The method for preparing the keloid mechanical balance microneedle according to claim 1, characterized in that: The S1 is obtained by the following steps: S1.

1. Obtain the average thickness A of the scar tissue after surgery; S3.2, the average thickness A of S1.1 is used as the thickness of the scar structure, and the shape of the scar structure is a long strip; S3.

3. Embed the scar structure obtained in S3.2 into the skin structure, and the thickness of the skin structure is h, and 0mm<h≤5.0mm, to obtain the preliminary skin-scar finite element model.

3. The method for preparing the keloid mechanical balance microneedle according to claim 2, characterized in that: The S2 is specifically obtained by the following steps: S2.1, meshing the preliminary skin-scar finite element model obtained in S1, and proceeding to S2.2; S2.

2. Fix the edge of the scar structure and the skin structure, set the strain on both sides of the skin structure to Y, and 0%<Y≤10%, to obtain the skin-scar finite element model.

4. The method for preparing the keloid mechanical balance microneedle according to any one of claims 1 to 3, characterized in that: The microneedle parameters include the diameter D of the needle body, the height G of the needle body, and the distance L between the needle body and the adjacent needle body.

5. The method for preparing the keloid mechanical balance microneedle according to any one of claims 1 to 3, characterized in that: The preliminary skin-scar finite element model, the skin-scar finite element model, and the microneedle array model are all constructed in Soildwork software.

6. The method for preparing the keloid mechanical balance microneedle according to claim 3, characterized in that: The S2.1 specifically imports the preliminary skin-scar finite element model obtained in S1 into the Hypermesh software for meshing.

7. The method for preparing the keloid mechanical balance microneedle according to claim 3, characterized in that: In S2.2, the edge of the scar structure is fixed to the skin structure by using a rigids function.

8. The method for preparing the keloid mechanical balance microneedle according to claim 3, characterized in that: The h is 2 mm; The Y is 4%.

9. A mechanically balanced microneedle for keloid, characterized in that: A keloid mechanical balance microneedle prepared by the method for preparing a keloid mechanical balance microneedle according to any one of claims 1 to 8.

10. Use of the keloid mechanical balance microneedle as claimed in claim 9 in preparing a product for preventing the recurrence of keloid.

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