WO2014059667A1

WO2014059667A1 - Radioactive seed implanting template and manufacturing method thereof

Info

Publication number: WO2014059667A1
Application number: PCT/CN2012/083218
Authority: WO
Inventors: 刘树铭; 黄明伟; 郑磊; 石妍; 李伟; 郭华秋; 朱俏; 王威; 毛明惠; 吕晓鸣; 张�杰; 俞光岩; 张建国
Original assignee: 张建国
Priority date: 2012-10-19
Filing date: 2012-10-19
Publication date: 2014-04-24

Abstract

The present invention relates to a design idea of a radioactive seed implanting template and a manufacturing method thereof. The manufacturing method comprises the following steps: (1) collecting image data about tumor portions of patients by using a scanning system; (2) a curing plan system reading the image data obtained in step (1) and drawing up a radioactive seed implanting plan according to the image data, to obtain picture data comprising locations, quantity and directions of needle passages and seed distribution information; (3) an image control system and a template design system processing the picture data on the basis of the picture data comprising locations, quantity and directions of needle passages and seed distribution information in step (2), and performing design to obtain a template digital model having patient facial morphology information, and locations, quantity and direction distribution information of needle passages; and (4) a template forming system forming a physical object by using the template digital model in step (3) as the template, to obtain a physical radioactive seed implanting template after preparation. The template of the present invention is accurate and stable in positioning, and basically eliminates the setup errors.

Description

Instruction manual

Radioactive particle implantation template and manufacturing method thereof

The present invention relates to the field of tumor treatment devices, and in particular, to a radioactive particle implantation template and a method of fabricating the same. Background technique

Radioactive particle brachytherapy is a kind of radiotherapy, which has the advantages of minimally invasive, highly "conformal", high local control rate and few complications. Radioactive particle brachytherapy has been widely used in the treatment of prostate cancer, breast cancer, head and neck cancer, and the like. Especially in the treatment of prostate cancer, the United States and some European countries have recommended ¹²⁵ 1 radioactive seed implantation therapy as the first choice for early prostate cancer treatment.

Interstitial implantation of radioactive particles requires that the implant needles be implanted in parallel with the target area. The particle distribution is such that the dose in the target area is high and as uniform as possible, and the normal tissue receives a small dose. To solve the above problems, the classic radioactive particle implantation treatment is template-injected under image guidance. At present, the most mature prostate cancer radioactive seed implantation treatment in the world is usually guided by transrectal ultrasound, and is implanted by a conventional uniform specification template as shown in Fig. 1. The template is provided with a needle insertion channel, which will be inserted into the plant. A needle is inserted into the channel for implantation of radioactive particles.

At present, the use of radioactive particles at home and abroad for the treatment of head and neck malignant tumors generally draws on the experience of prostate cancer treatment, and often scales under the guidance of ultrasound or CT images. However, due to the complex anatomy of the head and neck and the flexibility of its movement, the placement error (the deviation of the position or angle between the patient and the template) is highly prone to the application of the conventional template, which makes the treatment inconsistent with the plan and reduces the accuracy of the treatment. . This may result in a decrease in the radiation dose in the target area, an increase in the dose received by normal tissues, an effect on the treatment, and an increase in complications. This also reduces the application value of conventional templates and hinders the application of radioactive particle brachytherapy in the treatment of head and neck malignant tumors. However, if the template is not used, it is difficult to achieve precise insertion requirements during implantation, and the dose distribution is not up to standard.

In addition, the problem is not only in the treatment of head and neck malignant tumors, but also in other locations of the tumor. Due to the difference in the position and shape of the tumor, it is also very easy to implant the radioactive particles using a conventional template. Position error (template position or angle deviation), Therefore, in order to obtain good curative effect in the treatment of malignant tumors, accurate implantation of radioactive particles becomes the key, and the conventional templates and devices currently used must be improved to achieve the above objectives. Summary of the invention

In order to solve the above problem that radioactive particle implantation is highly prone to occur in the treatment of malignant tumors of the head and neck or other parts, and the treatment is not in accordance with the plan, the present invention designs a personalized template, which is located at the site of the patient's tumor. The morphology (e.g., facial morphology) is consistent, and the template has information on the treatment plan (including the position, orientation, and number of information of the radioactive particles implanted in the needle), thereby more accurately implanting.

The method for fabricating the radioactive particle implantation template of the present invention comprises the following steps:

(1) collecting image data of a tumor site of the patient through a scanning system;

(2) The treatment planning system reads the image data obtained in the step (1) and formulates a radioactive particle implantation plan based on the image data, and obtains image data including the position, number, and direction distribution information of the needle track;

(3) The image control system and the template design system are based on the image data including the position, the number, and the direction distribution information of the needle track in the step (2), and the image data is processed to design the shape of the part containing the patient's tumor. a template digitization model of information, position, number, and direction distribution information of the needle; wherein, the tumor is located not only in the tumor target region but also in a region in which the tumor growth site is larger, for example, according to a head and neck cancer When the image data is used to reconstruct a three-dimensional image of the location of the patient's tumor, the three-dimensional image of the site where the tumor is located includes not only the image of the tumor target region, but also the head and neck, the facial image and the morphology; the tumor region in the present invention is not specifically described. Refer to this explanation;

(4) The template forming system is solid-formed by using the template digitization model described in the step (3) as a template to prepare a solid radioactive particle implantation template.

Preferably, the step (3) comprises the following steps:

(3-1) The image control system reads step (2) image data including the position, number, direction, and particle distribution information of the needle track, and reconstructs a three-dimensional image of the part where the patient's tumor is located based on the image data, and imports Implanting plan information to generate a three-dimensional image containing the implant needle;

(3-2) The template design system reading step (3-1) includes a three-dimensional image of the implant needle, and According to the three-dimensional image design template digitization model, a template digital model containing the shape information of the location of the patient's tumor, the position, number and direction distribution information of the needle track is obtained.

Preferably, in step (3-2), the template digitizing model is adjustable in size by the template design system, but the tumor implantation area must be covered, and extended, covering the anatomical label as a preferred step, step (3) The thickness of the template digitized model and the diameter of the needle track are adjustable, preferably 5-6 mm in thickness and 1.3 mm in needle diameter.

Preferably, in step (3), the template digitization model is adjusted by a template design system using a Boolean subtraction operation.

Preferably, the template forming system in the step (4) utilizes a computer-controlled photocuring rapid prototyping machine according to the template digitizing model, and the radioactive particle implantation template can be processed using a medical photosensitive resin material.

The present invention also provides a radioactive particle implantation template obtained by the above manufacturing method. In addition, the present invention also provides a radioactive particle implantation apparatus, the apparatus comprising the above-described radioactive particle implantation template, and further comprising a scanning system, a treatment planning system, an image control system, a template design system, and a template forming system. .

Advantageously, the apparatus further comprises a radioactive particle implantation system, wherein the radioactive particle implantation system is capable of implanting radioactive particles at the malignant tumor site using the radioactive particle implantation template under the guidance of a CT image.

Preferably, the device further comprises a post-operative quality verification system for verifying the implantation condition, analyzing the particle distribution and the dose distribution, and further, the quality verification system performs a CT examination on the patient and then reads through the treatment planning system. CT images were taken to verify the implantation.

The inventive design digital model individualized template is prepared according to the CT image data containing the TPS treatment plan information, and is adapted to the facial shape characteristics of the patient, so that the template positioning is accurate and stable, and the placement error is substantially eliminated; Contains information on the position, orientation, and number of radioactive particles implanted into the needle. This facilitates accurate insertion; digital templates also reduce the "invalid needle" interference, improve implant efficiency, and reduce operating time compared to conventional templates. DRAWINGS The following drawings of the invention are hereby incorporated by reference in their entirety in their entirety. The embodiments of the present invention and the description thereof are shown in the drawings and are in the In the drawing,

1 is a conventional radioactive particle implantation template in the prior art;

2 is a three-dimensional image of a facial morphology of a head and neck tumor patient of the present invention;

3 is a schematic view showing the preparation of a digital template by using a three-dimensional image of the facial morphology of a head and neck tumor patient of the present invention;

Figure 4 is an implant template prepared according to the present invention;

Figure 5 is an implanted template comprising a bump prepared in accordance with the present invention. detailed description

In the following description, numerous specific details are set forth in the However, it will be apparent to those skilled in the art that the present invention may be practiced without one or more of these details. In other instances, some of the technical features well known in the art have not been described in order to avoid confusion with the present invention.

The method for preparing the radioactive particle implantation template of the present invention is further illustrated by taking a template of a head and neck tumor patient as an example, but those skilled in the art know that the method is not limited to the preparation of a template for a head and neck tumor. The method can also be applied to the preparation of templates for other malignant tumors that are difficult to control. Similarly, the device of the present invention is not limited to the treatment of head and neck tumors, and can be applied to the treatment of any other malignant tumors that are difficult to control. The following specific devices are merely exemplary and are not intended to limit the invention. Those skilled in the art can find other suitable alternative devices from the prior art to achieve the corresponding functions.

The invention provides a method for fabricating a radioactive particle implantation template, and the manufacturing method comprises the following steps:

(2) The treatment planning system reads the image data obtained in the step (1) and formulates a radioactive particle implantation plan based on the image data to obtain image data including the position, number, direction, and particle distribution information of the needle track;

(3) The image control system and the template design system process the image data based on the image data including the position, number, direction and particle distribution information of the needle track in the step (2). A template digitization model containing information on the facial shape of the patient, the position, number and direction distribution information of the needle track is obtained;

The scanning system in the step (1) is used for scanning system to collect image data of a tumor part of a patient, specifically, scanning a patient to obtain image data of a tumor part, and the thickness of the scanning layer may be 0.75 mm or more, and the control is performed. The scope of the scanning surface covers the tumor site of the patient and appropriately extends to the peripheral portion, so as to accurately obtain the soft and hard tissue information of the scanned area of the patient;

In a specific embodiment of the present invention, a patient with head and neck malignant tumors requiring radioactive particle therapy is selected, and a 32-slice CT scan is performed before surgery, and the scanning layer thickness is 0.75-lmm, and the scanning range is up to the frontal bone level. The level of the hyoid bone is used to accurately obtain the soft and hard tissue information of the scanned area of the patient. After acquiring the CT image data, it is stored in the Duxrn format. It should be noted that a scanning device capable of scanning a patient's tumor site for obtaining relevant information in this step can be used in the present invention, and is not limited to a certain device or a device produced by a certain manufacturer.

The treatment planning system described in the step (2) is used to read the image data obtained in the step (1) and formulate a radioactive particle implantation plan according to the image data to obtain a position, a number, a direction, and a particle distribution containing the needle track. The image data of the information; in the present invention, the treatment planning system can be processed according to the image data in the step (1) to obtain information such as a treatment method, and is not limited to a certain method or software, but It is better to explain how the treatment planning system processes data according to the data to obtain image data containing the position, number, direction and particle distribution information of the needle track. A specific embodiment is provided below:

Specifically, the treatment planning system (TPS) can provide a three-dimensional visualization guide platform for a tumor target area, which is a dose field for precise treatment, and the system can include a computer, a high-resolution high-speed image scanner, and software supporting Dicom. The TPS can satisfy the fusion of image sequences, electronic data, electron density, image scanning coexistence and rapid conversion, and can give three-dimensional target area isodose line, isodose surface, dose profile histogram, volume dose histogram, conformal Index, conformal rate, dose assessment and optimization, and verification of implant plans.

The treatment planning system (TPS) determines the target area based on imaging data such as images obtained by the scanning system, and determines the position, number, direction, and particle of the implanted needle according to the contour and cross section of the tumor. Quantity and particle activity, total activity. The dose distribution was observed by TPS, and the needle path and particle position were adjusted to obtain the optimal dose distribution. Specifically, the target area of the tumor should be carefully determined first, and the GTV or PTV profile should be drawn. The target volume (TVR) is required = the total volume of the prescribed dose / the total volume of the tumor, and the TVR should be between 1.5 and 2.0. The particles should be in the correct position after implantation.

Preferably, the present invention can select a CT image processing data in a scanning system by using a computerized three-dimensional treatment planning system (TPS, provided by Beijing University of Aeronautics and Astronautics, operating system is Windows XP Professional SP2), and formulate radioactive tissue interstitial implantation. Into the plan, including the number of needles, direction, particle distribution and other information, the CT image data containing the planning information is exported and stored in Dicom format.

The image control system used in the step (3) is configured to read image data including position, number, direction and particle distribution information of the needle track, and reconstruct a three-dimensional image (including a tumor site) of the patient's facial shape according to the image data. And importing the implantation plan information to generate a three-dimensional facial morphological image including the implanting needle; the template design system is configured to read the three-dimensional facial morphological image, and design a template digital model according to the three-dimensional facial morphological image to obtain a needle-containing image A template digitization model of number, direction, and particle distribution information.

Wherein, an image control system capable of reading image data including the position, number, direction, and particle distribution information of the needle track and converting it into a three-dimensional skin image can be used in the present invention, and is not limited to a certain one. In an embodiment of the present invention, the image control system reads CT image data containing the plan information, reconstructs a facial morphological image of a patient's tumor site, and inputs the needle information into a radioactive particle insertion. A three-dimensional image of the facial shape of the implant, as shown in Figure 2.

Preferably, the image control system comprises three-dimensional reconstruction software. Preferably, in the present invention, MimicslO.01 software (Materialise, Belgium) is used, and the MimicslO.01 software reads Duxrn data containing treatment plan information, and reconstructs the patient. The 3D model of the head and neck morphology was edited to generate a three-dimensional image of the facial morphology containing the radioactive particle implant needle, which is located in the region 2 where the radioactive particles need to be implanted, as shown in FIG.

Similarly, the template design system is not limited to only one software or method, as long as the digital template can be designed based on the three-dimensional facial shape image, and the designed template and the tumor portion shape can be matched, in a specific implementation. In the mode, the obtained 3D image data is exported to Geomagic 8.0 software (Geomagic, USA) in STL format, and according to the facial morphology The three-dimensional image design digitization template requires the template digitization model to include facial shape information, needle path information and cover the face implantation area. Preferably, the template digitization model may also extend the coverage anatomical landmark point appropriately to facilitate intraoperative according to the patient. Facial anatomical landmark positioning template. Preferably, the template is thickened to 5-6 mm, and the needle diameter is set to 1.3 mm (according to the outer diameter of the radioactive seed implant needle); preferably, the image is further processed by Boolean subtraction to obtain a template with needle information. The digitized model, as shown in Fig. 4, is completely consistent with the three-dimensional image of the face, and can completely cover the tumor site, and can better guide the implantation of the particles.

The template forming system in the step (4) is used for physically forming the template digitized model as a template, and preparing a physical radioactive particle implantation template. Specifically, according to the digitized model of the template, a computer-controlled photocuring rapid prototyping machine Eden250 (Olyet, Israel) is used to process the radioactive particles into individualized templates using a medical photocurable resin, preferably a photosensitive resin material. The information on the position, number and direction distribution of the needle track defined by TPS is included, and the template has a thickness of 5-6 mm and a needle track diameter of 1.3 mm. The prepared template is consistent with the morphology of the site in which the patient implants the radioactive particles, and when the template is implanted, the pendulum which occurs when the radioactive particles are implanted due to the difference in the position of the patient, the position and shape of the tumor can be eliminated. The bit error improves the accuracy of the treatment. It should be noted that, in the step, the template forming system can be converted into a solid method and the device are all within the protection scope of the present invention, and are not limited to the curing rapid forming machine in the device described in the embodiment. Eden250 and photocurable resin can be selected by a person skilled in the art according to specific needs.

The template of the present invention has a protrusion including a needle insertion channel at a needle position for assisting implantation of the insertion needle, as shown in FIG. 5, the protrusion as a guide can further ensure implant insertion The time is a parallel state to improve the accuracy, and it is also possible to fix the insertion needle. Preferably, the protrusion is cylindrical, but is not limited to the shape, as long as the function can be performed. The shape may be used in the present invention. As a further preferred, the protrusion may be integrally formed with the template, and the template digital model is controlled to form the protrusion on the model during the preparation process, and then the body is formed, and the obtained template is obtained. The protrusion and the protrusion are integrally formed, but the invention is not limited to the solution, and a split type protrusion may also be selected, and the object may be achieved by mounting the split type protrusion into the insertion needle hole.

In addition, the present invention also provides a radioactive particle implanting device, the device comprising a scanning system, a treatment planning system, an image control system, a template design system, a template forming system, and a a radioactive particle implantation system and a post-operative quality verification system; wherein the scanning system, the treatment planning system, the image control system, the template design system, and the template forming system all use the system and equipment described in the template preparation method, as long as Any device capable of achieving the described functions can be used for the device, and is not limited to the embodiment. Therefore, in order to avoid repetition, only the radioactive particle implantation system and the post-operative quality verification system are further explained below.

The radioactive particle implantation system can perform radioactive particle implantation on the malignant tumor site by using the radioactive particle implantation template under the guidance of the CT image, or directly apply the radioactive particle implantation template to perform radioactive particles on the malignant tumor site. Implantation, individualized template can be seen during operation, accurate positioning, good stability, and easy to carry out planting operation; implantation of radioactive particles in the radioactive particle implantation system can be short-term planting or permanent planting, The technician can make a selection according to the needs. As a preference, ¹⁹⁸ Au, ^1Q3 Pd or ¹²⁵ 1 can be selected when permanently growing the particles, and the particles have weak penetrating power, are clinically easy to protect, and have little damage to patients and medical personnel.

In a specific embodiment, the radioactive particle implantation system may be an implantation gun or an implantation needle, as long as the radioactive particles can be implanted under the guidance of the radioactive particle template, and those skilled in the art can Ask for a choice. In an embodiment of the present invention, the radioactive particle implantation system includes a radioactive particle storage tank, a particle channel, a planting needle, and the like. Specifically, the prepared radioactive particle is implanted into the template and placed in the radioactive particle to be implanted. The tumor site, enabling the template to correspond to the implant site, and then implanting the implant needle according to the position, number and direction of the needle track on the template, since the template has a certain thickness, When inserting the implant needle, it can ensure that the multiple implant needles are arranged in parallel, which overcomes the problem of inaccurate interval of the empirical particle implantation and deflection of the guide needle, and then controls the switch on the particle storage tank through the particles. Channels and puncture needles implant radioactive particles.

The postoperative quality verification system is used to verify the implantation status and analyze the particle distribution and dose distribution: The dose distribution after radioactive particle implantation is closely related to the efficacy and complications, and the quality of the implanted particles must be improved in order to improve the efficacy. For evaluation, the most important is the post-implantation dose verification analysis. It is necessary to verify the quality of the particle planting by CT scan, whether the spatial distribution of the particles after planting is consistent with the previous treatment plan, whether the dose distribution is mutated and whether the planted particles are displaced, therefore, the device according to the present invention Also included is a post-operative quality verification system, specifically, in one embodiment of the invention, 1-2 days after radioactive seed implantation of the patient, The patient underwent CT examination, and then the CT image data was read by the TPS system to verify the implantation and analyze the particle distribution and dose distribution (D90, V100, V150). The implanted information is fed back early by the quality verification system, and the underdose can be supplemented by re-implantation or external irradiation.

In the present invention, computer digital technology plays a very important role in the production of individualized templates. Spiral CT scanning is a routine examination before radioactive seed implantation, and its layer thickness is 0.75 mm, which can accurately obtain the soft and hard of the patient scanning area. Organize information. The TPS treatment planning system, Mmncs software, Geomagic software, etc. make full use of CT image data, and do not require patients to add new inspection items. Mimics software's 3D reconstruction technology uses the perspective function to clearly display the needle information and patient facial information on the same image, and can be rotated freely in the 3D window, so that the individual template design covers the needle information and facial positioning feature information. Simple and feasible. Using rapid prototyping technology, templates with individualized needle information and facial feature information can be accurately obtained, which facilitates accurate implantation of radioactive particles.

The present invention has been described by the above-described embodiments, but it should be understood that the above-described embodiments are only for the purpose of illustration and description. Further, those skilled in the art can understand that the present invention is not limited to the above embodiments, and various modifications and changes can be made according to the teachings of the present invention. These modifications and modifications are all claimed in the present invention. Within the scope. The scope of the invention is defined by the appended claims and their equivalents.

Claims

claims

1. A method of manufacturing a radioactive particle implantation template, characterized in that the manufacturing method includes the following steps:

(1) Collect imaging data of the patient’s tumor site through the scanning system;

(2) The treatment planning system reads the image data obtained in step (1) and formulates a radioactive particle implantation plan based on the image data to obtain image data containing the position, number, direction and particle distribution information of the needle tracks;

(3) The image control system and template design system are based on the image data containing the position, number, direction and particle distribution information of the needle tracks in step (2), process the image data, and design the image data containing the location of the patient's tumor. Template digital model with morphological information, pin track location, number and direction distribution information;

(4) The template molding system uses the digital model of the template described in step (3) as a template to perform physical molding to prepare a physical radioactive particle implantation template.

2. The method for making a radioactive particle implantation template according to claim 1, characterized in that the step (3) includes the following steps:

(3-1) The image control system reads the image data containing the position, number, direction and particle distribution information of the needle tracks in step (2), reconstructs a three-dimensional image of the patient's tumor location based on the image data, and imports it. Implantation plan information to generate a three-dimensional image including the implantation needle;

(3-2) The template design system reads the three-dimensional image of the implant needle contained in step (3-1), and designs a digital model of the template based on the three-dimensional image to obtain the morphological information of the patient's tumor location, the position of the needle track, Template digital model of number and direction distribution information.

3. The method for making a radioactive particle implantation template according to claim 2, characterized in that in step (3-2), the size of the obtained template digital model is adjustable through the template design system.

4. The method for making a radioactive particle implantation template according to claim 1, characterized in that the digital model of the template in step (3) covers the tumor implantation area and extends appropriately to cover anatomical landmarks.

5. The method for making a radioactive particle implantation template according to claim 1, characterized in that the thickness of the template digital model in step (3) is adjustable and the needle track diameter is adjustable.

6. The method for making a radioactive particle implantation template according to claim 1, characterized by In step (3), the template design system uses a Boolean subtraction operation to adjust the template digital model.

7. The method for making a radioactive particle implantation template according to claim 1, characterized in that the thickness of the template is 5-6mm, and the diameter of the needle track is 1.3mm.

8. The method of making a radioactive particle implantation template according to claim 1, characterized in that the template has a protrusion containing an implantation needle channel at the needle track position for assisting the implantation of the implantation needle.

9. The method for making a radioactive particle implantation template according to claim 8, wherein the protrusion is integrally formed with the template, and the protrusion is cylindrical.

10. The method for making a radioactive particle implantation template according to claim 1, characterized in that the template molding system in step (4) utilizes a computer-controlled light-curing rapid prototyping machine based on the template digital model and uses medical photosensitive resin The material is processed to obtain a radioactive particle implantation template.

11. A radioactive particle implantation template obtained by the manufacturing method according to any one of claims 1 to 10.

12. A radioactive particle implantation device, characterized in that the device includes a radioactive particle implantation template as claimed in claim 9.

13. The radioactive particle implantation device according to claim 12, characterized in that the device further includes a radioactive particle implantation system, and the radioactive particle implantation system utilizes the radioactive particles with or without guidance of CT images. The implantation template is used to implant radioactive seeds into the malignant tumor site.

14. The radioactive particle implantation device according to claim 12, characterized in that the device further includes a postoperative quality verification system for verifying the implantation situation and analyzing particle distribution and dose distribution.

15. The radioactive particle implantation device according to claim 14, characterized in that the quality verification system verifies the implantation by performing a CT examination on the patient and then reading the CT image data through the treatment planning system.