CN117731967A - Manufacturing method of personalized applicator for shallow X-ray radiotherapy - Google Patents

Abstract

The invention relates to the technical field of shallow X-ray radiotherapy, and solves the technical problems that a standardized applicator cannot adapt to a unique lesion shape and a body surface structure of a patient, cannot be used for accurate treatment and only can irradiate a lesion area and surrounding normal tissues at the same time, in particular to a manufacturing method of a personalized applicator for shallow X-ray radiotherapy. The applicator manufactured by the invention can provide customized treatment aiming at the unique treatment requirement of each patient, so that X-rays directly act on a target area, the radiation to surrounding normal tissues is reduced, the accuracy of radiotherapy is improved, and the treatment effect is enhanced.

Description

Manufacturing method of personalized applicator for shallow X-ray radiotherapy

Technical Field

The invention relates to the technical field of shallow X-ray radiotherapy, in particular to a manufacturing method of a personalized applicator for shallow X-ray radiotherapy.

Background

Shallow X-ray radiation therapy (SRT) is a non-invasive method for treating skin cancer and other shallow skin conditions that involves using low energy X-rays to penetrate only the shallow layers of the skin, minimizing the impact on deep tissues. Thus, this technique requires the applicator to precisely position the treatment area to ensure therapeutic efficacy while protecting the surrounding healthy skin. However, the applicators used in the prior art are not personalized, so that the following problems exist in the process of performing shallow X-ray radiotherapy:

1. standard applicators cause equivalent dose exposure to all tissues within the applicator, but there is a high probability that there will be a certain area of normal tissue within the applicator, which can result in unnecessary exposure of surrounding healthy tissue, increasing treatment risk and side effects;

2. standardized applicators do not adapt to the unique lesion shape and body surface structure of each patient, which can result in inaccurate treatment, inability to maximally adapt to individual differences of patients, and when the lesion area is not precisely irradiated, higher doses may be required to ensure the treatment effect, which further increases potential damage to normal tissue;

3. organ-at-risk shielding is missing, and treatment accuracy is difficult to ensure: at present, shielding protection is carried out on peripheral organs at risk except an applicator during shallow X-ray treatment, but shielding protection cannot be carried out on normal tissues and organs at risk in the field of the applicator; in clinic, in order to ensure that the volume of organs at risk in the field of the applicators is as small as possible, it is generally necessary for a worker to precisely adjust the position of the smaller applicators, on the one hand, to increase the total treatment time, and on the other hand, too small applicators may cause the diseased tissue to receive insufficient dose, cause dose loss, and may cause recurrence after treatment.

Disclosure of Invention

Aiming at the defects of the prior art, the invention provides a manufacturing method of a personalized applicator for shallow X-ray radiotherapy, which solves the technical problems that a standardized applicator cannot adapt to the unique lesion shape and body surface structure of a patient, cannot be used for accurate treatment and can only irradiate the lesion area and surrounding normal tissues.

In order to solve the technical problems, the invention provides the following technical scheme: a method for manufacturing a personalized applicator for shallow X-ray radiation therapy, comprising the following steps:

s1, performing three-dimensional imaging on a lesion part of a patient to obtain a three-dimensional medical image containing detailed information of a treatment area;

s2, preprocessing the three-dimensional medical image to improve the resolution of the image;

s3, carrying out target region sketching on the three-dimensional medical image by adopting automatic sketching software to obtain a target region outline, and marking the boundary of a lesion area, including all visible tumors or lesion tissues;

s4, identifying the skin surface in the medical image, and projecting the whole target area outline to the skin surface to determine a first projection area of the target area outline on the skin surface;

s5, selecting an applicator with a proper diameter size according to the first projection area as a treatment applicator so as to ensure that the applicator covers the whole target area outline and reduces radiation to normal tissues at the same time;

s6, determining a second projection area of normal tissues to be protected according to the total area of the skin surface contour covered by the treatment applicator and the first projection area;

s7, designing a three-dimensional model of the shielding sheet matched with the treatment applicator according to the second projection area by adopting three-dimensional design software, and printing out the shielding sheet by using a 3D printer through a proper material;

s8, mounting the shielding sheet at the port of the treatment applicator in a buckling or knob mode to form a personalized applicator, so as to ensure that the shielding sheet correctly covers normal tissues and the radioactive rays are directly aligned to a lesion area;

s9, the physician positions the personalized applicator in the treatment area of the patient, and X-ray irradiation is carried out according to the treatment plan.

Further, in step S1, three-dimensional imaging including but not limited to ultrasound, OCT, MRI, CT or other suitable three-dimensional medical imaging is performed.

Further, in step S3, the target area sketching is divided into a physician manual sketching and an automatic sketching, and the physician manual sketching is that the physician manually performs accurate sketching on the target area in software by using automatic sketching software;

and automatically sketching, namely automatically completing sketching of the target area by automatic sketching software to obtain a target area mask containing all areas in the target area, wherein the sketched target area mask supports manual adjustment.

Further, in step S4, the specific process includes the following steps:

s41, identifying the surface contour and geometric features of the skin containing the lesion part by adopting an edge detection algorithm;

s42, extracting a three-dimensional surface model of the skin of the lesion part according to the surface profile and the geometric characteristics by adopting a three-dimensional reconstruction algorithm;

s43, identifying a two-dimensional plane of the upper surface of the skin of the lesion site in the three-dimensional surface model by using a UV unfolding method, and aligning the two-dimensional plane with the outline of the target area;

s44, dividing the target area into a part above the skin surface and a part below the skin surface by adopting an image dividing method;

s45, projecting the whole target area outline to the skin surface by using an orthogonal projection algorithm to obtain a first projection area.

Further, in step S41, the edge detection algorithm employs a sobel filter or a Canny edge detection algorithm.

Further, in step S5, the shape of the applicator port is circular or elliptical, and the diameter size is 1-5cm in various specifications for selection.

Further, in step S6, the specific process includes the steps of:

s61, introducing a port of a diameter circle corresponding to the treatment applicator into automatic sketching software, and aligning the center of the port with the shape center of the first projection area;

s62, attaching the port to the skin surface, and carrying out Boolean operation on the contour of the port and the skin surface to obtain an intersection, so as to obtain the contour of the skin surface covered by the treatment applicator;

s63, performing Boolean operation on the total area of the skin surface profile and the first projection area, and taking the complement of the first projection area compared with the total area of the skin surface profile, namely obtaining the second projection area of the normal tissue to be protected during treatment.

Further, in step S61, the shape center is calculated in a cartesian coordinate system by using an integral method, or the centroid thereof is determined using any one of three-dimensional modeling software Blender or Maya or 3ds Max.

By means of the technical scheme, the invention provides a manufacturing method of a personalized applicator for shallow X-ray radiotherapy, which has at least the following beneficial effects:

1. the applicator manufactured by the invention can provide customized treatment according to the unique treatment requirements of each patient, thereby enhancing the treatment effect and conforming to the advanced treatment concept.

2. The invention makes the applicator and the shielding sheet according to the unique lesion shape and body surface structure of the patient, can precisely cover the treatment area, enables the X-rays to directly act on the target area, reduces the radiation to surrounding normal tissues, and improves the accuracy of radiotherapy.

3. The invention can optimize the distribution of radiation dose by accurately sketching and calculating the target area and surrounding normal tissues, ensure that the radiation energy with enough dose is concentrated on pathological tissues, and simultaneously reduce the radiation exposure to healthy tissues.

4. The invention can effectively protect normal tissues of patients, reduce side effects and complications caused by radiation and improve the safety of treatment by using the personalized shielding sheet.

5. The personalized applicator manufactured by the invention plays a certain role in positioning after limiting the treatment range, has a certain reference meaning for treatment positioning, can provide repeatability of fractional treatment, reduces positioning errors, reduces treatment preparation time due to the design and use of the personalized applicator, improves the efficiency of the treatment process, and enables patients and medical institutions to benefit from the treatment.

6. The manufacturing method provided by the invention is easy to standardize and copy, is beneficial to popularization and use in different medical institutions, and promotes popularization of high-quality shallow X-ray radiotherapy service.

Drawings

The accompanying drawings, which are included to provide a further understanding of the application and are incorporated in and constitute a part of this application, illustrate embodiments of the application and together with the description serve to explain the application and do not constitute an undue limitation to the application. In the drawings:

FIG. 1 is a flow chart of a method of making a personalized applicator of the present invention;

FIG. 2 is a schematic structural view of the personalized applicator of the present invention;

fig. 3 is a top view of the personalized applicator of the present invention.

Detailed Description

In order that the above-recited objects, features and advantages of the present invention will become more readily apparent, a more particular description of the invention will be rendered by reference to the appended drawings and appended detailed description. Therefore, the implementation process of how to apply the technical means to solve the technical problems and achieve the technical effects can be fully understood and implemented.

Shallow X-ray radiation therapy is a non-invasive method for treating skin cancer and other shallow skin conditions that involves using low energy X-rays to penetrate only the shallow layers of the skin, minimizing the impact on deep tissues. Thus, this technique requires precise positioning of the treatment area to ensure therapeutic efficacy while protecting the surrounding healthy skin.

The technical scheme disclosed in the prior art, such as a technical scheme disclosed by the publication No. CN115770361A and the name of the invention, namely a shallow tumor brachytherapy combined 3D printing treatment method, is provided, and is applicable to the field of brachytherapy, a 3D short-distance template entity is printed on the surface of the shallow tumor, and after-loading treatment is carried out by the applicator after the placement, however, the technical scheme is only applicable to the field of brachytherapy, the applicator printed by the 3D is not easy to fix, and the applicator can not be ensured to be always at one position during treatment.

Based on the technical problems of the prior art, the present embodiment aims to solve several key technical problems in the conventional shallow X-ray radiation therapy (SRT):

1. limitations of non-personalized treatments:

applicators used by conventional SRTs tend to be standardized and do not adapt to the unique lesion shape and body surface structure of each patient. This can result in inaccurate treatment and inability to accommodate the individual differences of the patient to the maximum extent.

2. Radiation risk of surrounding normal tissue:

standard applicators will result in equivalent dose exposure to all tissues within the applicator, but there is likely to be a region of normal tissue within the applicator, which can result in unnecessary exposure of surrounding healthy tissue to the radiation, increasing treatment risk and side effects.

3. Limitations of therapeutic effects:

when the lesion area is not precisely irradiated, a higher dose may be required to ensure therapeutic effect, which further increases the potential damage to normal tissue.

4. Organ-at-risk shielding is missing, and treatment accuracy is difficult to ensure:

at present, shielding protection is carried out on organs at risk around a target area except an applicator during shallow X-ray treatment, but shielding protection cannot be carried out on normal tissues and organs at risk in the field of the applicator; in clinic, in order to ensure that the volume of organs at risk in the field of the applicators is as small as possible, it is generally necessary for a worker to precisely adjust the position of the smaller applicators, on the one hand, to increase the total treatment time, and on the other hand, too small applicators may cause the diseased tissue to receive insufficient dose, cause dose loss, and may cause recurrence after treatment.

5. Lack of personalized treatment devices:

in the current shallow X-ray treatment field, the used applicators are universal applicators with different diameters, and the personalized applicators are not equipped temporarily; the manufacturing flow of the corresponding personalized applicator is already existing in the brachytherapy, but firstly, the flow is complicated, and the optimal Jie Shiyuan applicator is difficult to obtain; secondly, the personalized applicator is directly applied on the surface of the skin of a patient after manufacturing, and is difficult to keep fixed in the treatment process.

Based on the technical problems in the prior art, please refer to fig. 1-3, a specific implementation manner of the present embodiment is shown, and the present embodiment makes the applicator and the shielding sheet according to the unique lesion shape and body surface structure of the patient, so that the treatment area can be precisely covered, the X-ray can directly act on the target area, the radiation to the surrounding normal tissue is reduced, and the accuracy of radiotherapy is improved.

Referring to fig. 1, the present embodiment provides a method for manufacturing a personalized applicator for shallow X-ray radiotherapy, which includes the following steps:

s1, performing three-dimensional imaging on a lesion part of a patient to obtain a three-dimensional medical image containing detailed information of a treatment area, wherein the three-dimensional imaging comprises but is not limited to ultrasonic imaging, OCT, MRI, CT imaging or other applicable three-dimensional medical imaging; in the field of radiation therapy, a three-dimensional overall contour is delineated for a target region to be treated based on three-dimensional medical images to ensure that the treatment region is distinguished from the normal tissue region and a dose plan is performed.

In this step, accurate image data of the lesion site of the patient is acquired using ultrasound, OCT, MRI, CT or corresponding medical imaging techniques for patients diagnosed with malignant lesions of skin cancer (including types of skin cancer such as basal cell carcinoma, squamous cell carcinoma, etc.), benign lesions of keloids, and other skin lesions. This data will be used to determine the exact size and shape of the target volume, aided by monte carlo simulation techniques to assess the required radiation dose.

S2, preprocessing the three-dimensional medical image to improve the resolution of the image; the obtained three-dimensional medical image is utilized, and the collected image data is input into special medical image processing software to perform necessary preprocessing, such as denoising, contrast enhancement, edge sharpening and the like, so as to improve the image resolvability.

S3, carrying out target region sketching on the three-dimensional medical image by adopting automatic sketching software to obtain a target region outline, and marking the boundary of a lesion area, including all visible tumors or lesion tissues; the target area sketching is divided into manual sketching by a doctor and automatic sketching, wherein the manual sketching by the doctor is that the doctor manually performs accurate sketching on the target area in software by using automatic sketching software; and automatically sketching, namely automatically completing sketching of the target area by automatic sketching software to obtain a target area mask containing all areas in the target area, wherein the sketched target area mask supports manual adjustment.

In the operation of target region sketching, the sketching mode can be classified into manual sketching by a doctor or automatic sketching, wherein the manual sketching is that the doctor uses image processing software, taking deetvier as an example, after CT or other medical images are imported into the software, the accurate sketching is performed on the target region in the software to obtain the target region outline; the automatic sketching is as follows: taking the software deetviewer supporting automatic sketching as an example, the software is based on a U-Net network, a Resune network and an EfficiencyNet network, adopts a strategy of combining a 3D network and a 2D network, and can automatically complete sketching of a target area corresponding to a cancer disease by using the automatic sketching target area function, so as to obtain a target area mask containing all areas inside the target area, and the sketched target area mask supports manual adjustment. When delineating, the boundaries of the lesion area, including all visible tumors or lesions, need to be identified accurately.

The present embodiment optimizes the distribution of radiation doses by precisely delineating and calculating the target area and surrounding normal tissue, ensuring that sufficient doses of radiation energy are concentrated in the diseased tissue while reducing radiation exposure to healthy tissue.

S4, identifying the skin surface in the medical image, and projecting the whole target area outline to the skin surface to determine a first projection area of the target area outline on the skin surface; in step S4, the specific process includes the following steps:

s41, identifying the surface profile and geometric characteristics of the skin containing the lesion part by adopting an edge detection algorithm, wherein the edge detection algorithm adopts a Sobel filter (Sobel filter) or a Canny edge detection algorithm;

s42, extracting a three-dimensional surface model of the skin of the lesion part according to the surface profile and the geometric characteristics by adopting a three-dimensional reconstruction algorithm;

s43, identifying a two-dimensional plane of the upper surface of the skin of the lesion site in the three-dimensional surface model by using a UV unfolding method (UV Unwrapping), and aligning the two-dimensional plane with the outline of the target area;

s44, dividing the target area into a part above the skin surface and a part below the skin surface by adopting an image dividing method; the above-the-skin portion does not include a skin surface model, and the below-the-skin portion includes a skin surface contour.

S45, projecting the whole target area outline to the skin surface by using an orthogonal projection algorithm to obtain a first projection area. The entire target contour may be projected onto the skin surface using a projection algorithm, such as orthogonal projection (Orthographic Projection), and the two projections summed into a total projected area, which may appear as a plane or a curved surface, depending on the actual contour of the patient's skin, by taking a union of the image data.

S5, selecting an applicator with a proper diameter size according to the first projection area as a treatment applicator so as to ensure that the applicator covers the whole target area outline and reduces radiation to normal tissues at the same time; a best matching circular or elliptical applicator is selected according to the size of the resulting first projected area, the applicators being typically stored in groups, the applicators of one shape having 5 different maximum diameters, 1cm, 2cm, 3cm, 4cm, 5cm respectively, forming a group of applicators. The applicator that is capable of encompassing the total projected area of the target contours on the skin surface and that is most closely conforming to the first projected area is selected as the treatment applicator.

In this embodiment, in the field of shallow X-ray radiation therapy, a standard Applicator (Applicator) is composed of metal and a transparent annular material, open on both sides. One end of the metal is used for being connected with an X-ray beam outlet of the shallow X-ray treatment equipment, one end of the transparent annular material is used for being in direct contact with a target area of a patient, is used for limiting the X-rays for treatment to a certain area, and protecting normal tissues outside the applicators from direct irradiation by the rays, and the diameters of the ends of the applicators of different models are different.

Personalized applicators (Personalized Applicator): the personalized applicators are tailored to the site and type of disease that the patient is required to treat.

S6, determining a second projection area of normal tissues to be protected according to the total area of the skin surface contour covered by the treatment applicator and the first projection area; in step S6, the specific process includes the following steps:

s61, introducing a port of a diameter circle corresponding to the treatment applicator into automatic sketching software, and aligning the center of the port with the shape center of the first projection area; the shape center can be calculated in a Cartesian coordinate system by using an integral method, and the shape center can also be determined by using three-dimensional modeling software such as Blender, maya and 3ds Max.

S62, attaching the port to the skin surface, and carrying out Boolean operation on the contour of the port and the skin surface to obtain an intersection, so as to obtain the contour of the skin surface covered by the treatment applicator;

s63, performing Boolean operation on the total area of the skin surface profile and the first projection area, and taking the complement of the first projection area compared with the total area of the skin surface profile, namely obtaining the second projection area of the normal tissue to be protected during treatment.

S7, designing a three-dimensional model of a shielding sheet matched with the treatment applicator according to a second projection area by adopting three-dimensional design software, and printing the shielding sheet by using a 3D printer through a proper material, wherein the shielding sheet is a component made of one or more materials capable of shielding X-rays, such as lead or lead composite materials or other metal mixtures; can be combined with a conventional applicator to form a personalized applicator. In radiation therapy, a treated region is exposed while a non-treated region is protected from radiation.

For the three-dimensional model of the shielding sheet, three-dimensional design software such as Blender, maya and 3ds Max can be utilized, the model can be designed according to the obtained normal tissue, the shape and the size of the selected treatment applicator can be completely matched, then the designed three-dimensional model of the shielding sheet is transmitted to a 3D printer to serve as a data source for 3D printing, the shielding sheet is printed out by using a proper material, the actual thickness of the shielding sheet is set according to the 3D printing shielding sheet material which is actually adopted, the applicator material is taken as lead for example, and the thickness is generally 3-5 mm, so that the better protection effect can be realized in shallow X-ray radiotherapy. The shield design should ensure a continuous profile extending inwardly from the applicator edge. For the central part which is not directly connected with the edge of the applicator, the shielding sheet of the part is not required to be printed.

The embodiment can effectively protect normal tissues of a patient by using the personalized shielding sheet, reduce side effects and complications caused by radiation, and improve the safety of treatment.

S8, mounting the shielding sheet at the port of the treatment applicator in a buckling or knob mode to form a personalized applicator, so as to ensure that the shielding sheet correctly covers normal tissues and the radioactive rays are directly aligned to a lesion area; the conventional shallow X-ray applicator is simply modified, so that the personalized shielding sheets can be stably connected at the port of the applicator and installed in a buckle or knob mode, and the personalized shielding sheets of different patients can be installed on the same applicator, so that the applicability of the applicator is improved.

As shown in fig. 2 and 3, a dark circular groove with an oval hole at the upper left part in fig. 2 is a shielding sheet arranged for a patient in an oval lesion area, and the shielding sheet is arranged at an applicator port (a transparent area at the upper left corner in fig. 2) in a buckle or knob mode, so that a personalized applicator suitable for the patient is obtained.

S9, the physician positions the personalized applicator in the treatment area of the patient, and X-ray irradiation is carried out according to the treatment plan. The embodiment can manufacture the applicator and the shielding sheet according to the unique lesion shape and body surface structure of the patient, can precisely cover the treatment area, enables the X-rays to directly act on the target area, reduces the radiation to surrounding normal tissues, and improves the accuracy of radiotherapy.

Among them, the medical image processing techniques applied in the present embodiment include various techniques for acquiring and processing medical images (e.g., ultrasound, OCT, MRI, CT, etc.) in this field, which can be used to accurately identify and delineate a skin lesion area of a patient. Medical image processing techniques are used in the present invention to extract target contours from patient medical scan data and convert these data into a format suitable for 3D printing, while three-dimensional printing techniques are applied in the medical field:

the application of 3D printing technology in the medical field is mainly related to the manufacture of personalized medical devices, implants and models. In this embodiment, 3D printing techniques are used to create personalized shielding patches designed to the specific target contours of the patient, which can accurately mask non-target areas during radiation therapy, maximizing protection of surrounding healthy tissue.

In summary, the personalized applicator manufactured by the embodiment plays a certain role in positioning after limiting the treatment range, has a certain reference meaning for treatment positioning, can provide repeatability of treatment in times, reduces positioning errors, reduces treatment preparation time due to design and use of the personalized applicator, improves the efficiency of the treatment process, and enables patients and medical institutions to benefit from the treatment.

Those of ordinary skill in the art will appreciate that all or a portion of the steps in implementing the above-described example methods may be performed by a program to instruct related hardware and, thus, the present application may take the form of an entirely hardware embodiment, an entirely software embodiment, or an embodiment combining software and hardware aspects. Furthermore, the present application may take the form of a computer program product embodied on one or more computer-usable storage media (including, but not limited to, disk storage, CD-ROM, optical storage, and the like) having computer-usable program code embodied therein.

The foregoing embodiments have been presented in a detail description of the invention, and are presented herein with a particular application to the understanding of the principles and embodiments of the invention, the foregoing embodiments being merely intended to facilitate an understanding of the method of the invention and its core concepts; meanwhile, as those skilled in the art will have variations in the specific embodiments and application scope in accordance with the ideas of the present invention, the present description should not be construed as limiting the present invention in view of the above.

Claims (8)

1. A method for manufacturing a personalized applicator for shallow X-ray radiotherapy, which is characterized by comprising the following steps:

s1, performing three-dimensional imaging on a lesion part of a patient to obtain a three-dimensional medical image containing detailed information of a treatment area;

s2, preprocessing the three-dimensional medical image to improve the resolution of the image;

s3, carrying out target region sketching on the three-dimensional medical image by adopting automatic sketching software to obtain a target region outline, and marking the boundary of a lesion area, including all visible tumors or lesion tissues;

s4, identifying the skin surface in the medical image, and projecting the whole target area outline to the skin surface to determine a first projection area of the target area outline on the skin surface;

s5, selecting an applicator with a proper diameter size according to the first projection area as a treatment applicator so as to ensure that the applicator covers the whole target area outline and reduces radiation to normal tissues at the same time;

s6, determining a second projection area of normal tissues to be protected according to the total area of the skin surface contour covered by the treatment applicator and the first projection area;

s7, designing a three-dimensional model of the shielding sheet matched with the treatment applicator according to the second projection area by adopting three-dimensional design software, and printing out the shielding sheet by using a 3D printer through a proper material;

s8, mounting the shielding sheet at the port of the treatment applicator in a buckling or knob mode to form a personalized applicator, so as to ensure that the shielding sheet correctly covers normal tissues and the radioactive rays are directly aligned to a lesion area;

s9, the physician positions the personalized applicator in the treatment area of the patient, and X-ray irradiation is carried out according to the treatment plan.

2. The method of claim 1, wherein in step S1, three-dimensional imaging includes, but is not limited to, ultrasound, OCT, MRI, CT or other suitable three-dimensional medical imaging.

3. The method according to claim 1, wherein in step S3, the target area sketching is classified into a physician manual sketching and an automatic sketching, and the physician manual sketching is that the physician manually performs accurate sketching on the target area in software by using automatic sketching software;

and automatically sketching, namely automatically completing sketching of the target area by automatic sketching software to obtain a target area mask containing all areas in the target area, wherein the sketched target area mask supports manual adjustment.

4. The method according to claim 1, wherein in step S4, the specific process comprises the steps of:

s41, identifying the surface contour and geometric features of the skin containing the lesion part by adopting an edge detection algorithm;

s42, extracting a three-dimensional surface model of the skin of the lesion part according to the surface profile and the geometric characteristics by adopting a three-dimensional reconstruction algorithm;

s43, identifying a two-dimensional plane of the upper surface of the skin of the lesion site in the three-dimensional surface model by using a UV unfolding method, and aligning the two-dimensional plane with the outline of the target area;

s44, dividing the target area into a part above the skin surface and a part below the skin surface by adopting an image dividing method;

s45, projecting the whole target area outline to the skin surface by using an orthogonal projection algorithm to obtain a first projection area.

5. The method according to claim 4, wherein in step S41, the edge detection algorithm is a sobel filter or a Canny edge detection algorithm.

6. The method of claim 1, wherein in step S5, the shape of the applicator port is circular or elliptical, and the diameter size is 1-5 cm.

7. The method according to claim 1, wherein in step S6, the specific process comprises the steps of:

s61, introducing a port of a diameter circle corresponding to the treatment applicator into automatic sketching software, and aligning the center of the port with the shape center of the first projection area;

s62, attaching the port to the skin surface, and carrying out Boolean operation on the contour of the port and the skin surface to obtain an intersection, so as to obtain the contour of the skin surface covered by the treatment applicator;

s63, performing Boolean operation on the total area of the skin surface profile and the first projection area, and taking the complement of the first projection area compared with the total area of the skin surface profile, namely obtaining the second projection area of the normal tissue to be protected during treatment.

8. The manufacturing method according to claim 7, wherein in step S61, the shape center is calculated in a cartesian coordinate system by using an integral method or the centroid thereof is determined using any one of three-dimensional modeling software Blender or Maya or 3ds Max.