Prostate tumor thermal therapy equipment and method

Abstract

The invention relates to a prostate tumor thermal therapy device and method, the device comprises particles heating under the action of a magnetic field, and is characterized by further comprising an imaging positioning module, a particle implantation module, a particle fixing module, a magnetic field excitation module and a control and display module, the imaging positioning module comprises a multi-mode imaging device composed of an ultrasonic imaging unit, a CT scanning unit and an MRI imaging unit, and the multi-mode imaging device at least adopts two devices of the ultrasonic imaging unit, the CT scanning unit and the MRI imaging unit to construct a three-dimensional model of the prostate and the tumor. Through the arrangement, particles can be accurately positioned and fixed, the operation precision is improved, and the operation difficulty is reduced.

Description

Technical Field

[0001] The present invention relates to the technical field of hyperthermia, and in particular to a device and method for hyperthermia treatment of prostate tumors. Background Art

[0002] In China, its incidence rate has also increased significantly, with approximately 134,000 new cases in 2022, ranking sixth among male tumors.

[0003] The incidence of prostate cancer in China has risen rapidly over the past 30 years, driven by factors such as improved medical care, widespread screening, an aging population, and a Westernized diet. For example, incidence rates in developed regions like Shanghai are now approaching those in developed Europe and the United States. However, the staging composition of prostate cancer patients in my country differs significantly from that in developed Western countries. Only 30% of newly diagnosed cases in my country present with clinically localized disease at diagnosis, while the remainder present with locally advanced disease or widespread metastasis.

[0004] Prostate cancer can cause many health hazards: it can cause symptoms such as frequent urination, urgency, pain, weak urine flow, frequent urination at night, etc., and in severe cases affect sleep; in the late stage, it may invade adjacent tissues and organs or metastasize to other parts, such as bones, lymph nodes, lungs, liver, etc., leading to more serious illness and even life-threatening.

[0005] Currently, the main treatment options for prostate cancer include surgery, radiotherapy, and medication. Surgery carries a higher risk and is less suitable for older patients with more underlying medical conditions. Radiotherapy, however, is difficult to control due to its radioactive content and can easily cause radiation damage to surrounding tissues. Medication can cause numerous side effects, and even chemotherapy can kill normal cells.

[0006] For these reasons, a currently considered alternative is the use of hyperthermia particles. This approach utilizes an external energy field to excite particles implanted at the tumor site, causing them to generate heat and destroy tumor cells, thus overcoming the aforementioned drawbacks. However, currently, there are few hyperthermia systems specifically designed for prostate tumors. Summary of the Invention

[0007] In order to solve the above-mentioned defects, the present invention proposes a prostate tumor hyperthermia treatment device and a hyperthermia particle positioning method.

[0008] The technical solution adopted by the present invention is a prostate tumor thermal therapy device, which includes particles that generate heat under the action of a magnetic field, as well as an imaging positioning module, a particle implantation module, a particle fixation module, a magnetic field excitation module, and a control and display module. The imaging positioning module includes a multimodal imaging device consisting of three equipment units: an ultrasound imaging unit, a CT scanning unit, and an MRI imaging unit. The multimodal imaging device uses at least two of the ultrasound imaging unit, CT scanning unit, and MRI imaging unit to construct a three-dimensional model of the prostate and tumor.

[0009] Preferably, the imaging positioning module further comprises an electromagnetic positioning sensor, which is located on the implant needle and / or the particle and can respond to an external magnetic field for positioning.

[0010] Preferably, the particle fixing module comprises a biological glue coating coated on the surface of the particles, and the biological glue is one of fibrin glue, gelatin sponge glue and chitosan glue.

[0011] Preferably, the particle fixing module comprises a heat-activated adhesive material coating coated on the surface of the particles, wherein the heat-activated adhesive material undergoes a phase change when heated and adheres the particles to the target position.

[0012] Preferably, the heat-activated adhesive material is one of poly (N-isopropylacrylamide), gelatin-sodium glycerophosphate, and sodium alginate-calcium chloride.

[0013] Preferably, the particle fixing module further comprises a texture on the particle surface, wherein the texture comprises ridges, depressions or stripes.

[0014] The present invention also proposes a method for positioning thermotherapy particles, which is characterized in that it includes the following steps: acquiring an image of the treatment area and determining the tumor area, and then constructing a three-dimensional model of human tissue in the area to be treated through the image; determining the particle distribution position and implantation path with reference to the three-dimensional model to obtain a particle implantation plan; implanting the particles into the target position according to the implantation plan, and comparing and verifying the actual fixed position of the particles. If the actual fixed position deviation exceeds a preset range, the position is corrected.

[0015] Preferably, the method of acquiring an image of the treatment area and determining the tumor area, and then constructing a three-dimensional model of human tissue in the area to be treated by using the image, specifically includes: Two of the ultrasound imaging unit, CT scanning unit and MRI imaging unit are used to construct a three-dimensional model of the prostate and the tumor.

[0016] Preferably, the particles are implanted into the target position according to the implantation plan, and the actual fixed position of the particles is compared and verified, specifically: A small metal marker or special dye marker is used to form a marking positioning reference point on the patient's body surface or body, and the actual fixed position of the particle is determined by observing the relative position relationship between the reference point, the implant needle and the particle.

[0017] Preferably, the particles are fixed in position using bio-glue material.

[0018] Compared with the prior art, the present invention has the following beneficial effects: 1. The model combines image data from three modalities: ultrasound, CT, and MRI. It has high accuracy, integrity, and real-time adjustment capabilities, providing precise anatomical reference for seed implantation surgery. 2. Due to the high precision of the 3D model, the positioning of the particles during implantation is also highly precise. In addition, the positioning can be fed back and adjusted in real time. The implantation position of the particles can be stably controlled within the range of 0.5mm-1mm, which is a significant improvement compared to the conventional accuracy range of 2-5mm on the market. 3. To a certain extent, it reduces the surgical intensity of the surgeon and also reduces the difficulty of particle implantation and positioning. BRIEF DESCRIPTION OF THE DRAWINGS

[0019] Figure 1 It is a flow chart of the steps of the particle positioning method of the present invention. DETAILED DESCRIPTION

[0020] In order to make the purpose, technical solutions and advantages of the present invention clearer, the embodiments of the present invention will be described in further detail below. The embodiments are exemplary and are only used to explain the present invention, and should not be interpreted as limiting the present invention.

[0021] The present invention discloses a prostate tumor hyperthermia treatment device, comprising an imaging positioning module, a particle implantation module, a particle fixation module, a magnetic field excitation module, and necessary control and display modules. The imaging positioning module first scans and images the prostate of the human body, constructing a three-dimensional model in advance to provide an intuitive reference for subsequent treatment. It also provides real-time and accurate positioning and tracking during the particle implantation process, ensuring that the particle positioning accuracy can highly meet the accuracy requirements of the design scheme. The particle implantation module mainly includes an implantation needle and its ancillary facilities, allowing the operator to operate and accurately implant the particles into the target position. The particle fixation module is used to better fix the implanted particles in the prostate, reducing the displacement effects caused by various changes in the prostate and ensuring the effectiveness of the treatment. The magnetic field excitation module is used to excite the particles to generate heat. Finally, the control and display module is also very important. It is not only connected to the signals of all the above modules and provides software control functions, but also can collect relevant information in a timely manner and display it after processing for the operator and patient to view and reference.

[0022] The imaging and positioning module includes a variety of devices used in conjunction with each other, primarily consisting of a multimodal imaging device and a positioning and tracking system. The multimodal imaging device uses various imaging methods to provide different image information from different angles, allowing the user to gain a more comprehensive and clearer understanding of the patient's internal conditions. Based on this, the positioning and tracking system uses pre-established imaging model data to track particles in real time, achieving dynamic control and precise positioning. This ensures that particles land at the target location essentially according to the predetermined plan, greatly improving surgical accuracy.

[0023] In one embodiment, the multimodal imaging device primarily comprises three equipment units: an ultrasound imaging unit, a CT scanning unit, and an MRI imaging unit. While all three units can independently perform imaging, each has its own advantages and disadvantages. Therefore, in this embodiment, all three are used together, with the following focus on the image content provided by each imaging unit. Of course, in another embodiment, only one of the three units may be used.

[0024] Ultrasound Imaging Unit: Equipped with a high-resolution transrectal ultrasound probe, it can clearly display the prostate's morphology, size, and boundaries, as well as surrounding tissue structures (such as the urethra and rectum) in real time. The probe's frequency range is 7-12 MHz, allowing for imaging at varying depths. It provides multi-plane views of the prostate, including cross-sectional, sagittal, and coronal planes, facilitating observation of tumor location from all angles.

[0025] CT Scanning Unit: This unit integrates a miniaturized CT device to obtain detailed three-dimensional structural information of the prostate. Its spatial resolution should reach submillimeter levels (e.g., 0.5-1mm slice thickness), accurately displaying the spatial relationship between the prostate and surrounding bone structures (e.g., pubic bone and ischium), providing precise spatial positioning reference for seed implantation.

[0026] MRI imaging unit: MRI imaging can provide high-resolution images of prostate soft tissue, especially for more accurate visualization of tumor boundaries and internal structures. This unit primarily includes the radiofrequency coil and signal receiving device used for MRI scanning. It can adopt open or local MRI designs to accommodate examinations of the prostate area.

[0027] In one embodiment, corresponding image fusion software is also provided for fusing images obtained by ultrasound, CT, and MRI. Using image registration algorithms, the advantages of different imaging modalities are combined to accurately determine the location, size, and shape of the prostate tumor, while simultaneously generating a 3D reconstructed model. The software features both automatic and manual registration functions, allowing physicians to adjust the registration based on their specific needs, ensuring that the fused image accurately reflects the anatomical information of the prostate and tumor.

[0028] It should be noted that this solution uses a multi-modal imaging device for coordination, and its purpose is very clear. On the one hand, the three devices exemplified in the above embodiment can each use their own advantages. For example, the ultrasound imaging unit can provide multi-plane views of the prostate, such as the cross-sectional, sagittal, and coronal planes; the CT scanning unit is used to obtain fine three-dimensional structural information of the prostate; and the MRI imaging unit is used to display the tumor boundary and internal structure. By combining the advantages of these three, a more comprehensive and complete three-dimensional model can be constructed through software. On the other hand, for overall imaging, the imaging information can be verified by multiple parties, and doctors can also observe from multiple angles to reduce errors such as misjudgment and further improve accuracy.

[0029] As an example, in one embodiment, the construction of a three-dimensional prostate model based on acquired image data of three modalities, namely ultrasound, CT, and MRI, is described as follows: Before constructing a 3D model, preprocessing is required to ensure consistent image quality across all three modalities, facilitating subsequent registration and fusion. Image denoising is performed to remove noise and improve image quality. Algorithms such as non-local means (NLM) or wavelet denoising can be used. These algorithms effectively remove noise while preserving image detail. Image enhancement is then performed to enhance image contrast and clarity, facilitating subsequent segmentation and registration. Algorithms such as histogram equalization or contrast-limited adaptive histogram equalization (CLAHE) can be used. Enhancement is particularly effective for ultrasound and MRI images to improve soft tissue contrast. Finally, image normalization is performed to normalize the image data from different modalities to the same grayscale range and spatial resolution, facilitating subsequent registration and fusion. Linear normalization or Z-score normalization can be used.

[0030] After completing the above image preprocessing, image segmentation can be performed. Image segmentation is a key step in separating the prostate and its tumor from the background and other tissues. Prostate segmentation is performed first, aiming to extract the prostate contour from the image. Region-based segmentation algorithms (such as region growing) or edge-based segmentation algorithms (such as Canny edge detection) can be used. For MRI images, deep learning models (such as U-Net) can also be used for automatic segmentation. Tumor segmentation is then performed, aiming to extract the tumor contour from the image. Threshold-based segmentation algorithms or morphology-based segmentation algorithms can be used. Deep learning models (such as U-Net) can also be used for automatic tumor segmentation in MRI images.

[0031] After completing the aforementioned image segmentation, image registration can be performed. This step is a key step in aligning images of different modalities to the same spatial coordinate system. First, rigid registration is performed, the purpose of which is to preliminarily align ultrasound, CT, and MRI images and correct for translation and rotation differences in the images. A rigid registration algorithm based on mutual information (MI) or a registration algorithm based on feature points (such as SIFT) can be used. Subsequently, non-rigid registration is performed, the purpose of which is to further correct for nonlinear deformations between images and ensure that the details of the images are aligned. A non-rigid registration algorithm based on B-splines or a registration algorithm based on optical flow fields can be used to ensure that the contours of the prostate and tumor are completely aligned in images of different modalities.

[0032] With the above processing, image fusion processing can be performed to combine image data from different modalities to generate a comprehensive 3D model. Specifically, using image fusion algorithms based on wavelet transform or deep learning, ultrasound, CT, and MRI images are fused to generate a 3D model that includes prostate contours, tumor structure, and bone information.

[0033] After image fusion, a 3D reconstruction algorithm can be used to generate a 3D model of the prostate and its tumor. First, a Marching Cubes algorithm or Delaunay triangulation algorithm is used to generate a surface model of the prostate and tumor based on the fused image data. Ray casting or volume rendering is then used to generate a volume-rendered model of the prostate and tumor based on the fused image data, displaying the internal structure.

[0034] At this point, a high-precision 3D model of the prostate has been obtained. This utilizes multimodal imaging equipment, combining their respective advantages to significantly improve the model's precision and accuracy. Of course, other embodiments may also include model optimization and post-processing to improve model accuracy and visualization. This includes smoothing and simplification, as well as visualization using commonly used tools such as VTK (Visualization Toolkit) or Unity3D.

[0035] Through the above steps, image processing professionals can gradually construct a high-precision three-dimensional model of the prostate and its tumor. This model combines image data from ultrasound, CT, and MRI modalities, boasting high accuracy, completeness, and real-time adjustment capabilities, enabling precise anatomical reference for seed implantation surgery. It should be noted that the algorithms described in the above examples are prior art and are not the only implementations of these examples.

[0036] The tracking system primarily consists of electromagnetic positioning sensors: miniature electromagnetic positioning sensors are attached to the implant needle and / or thermotherapy particles. These sensors emit signals in a magnetic field, which are then received by an external electromagnetic positioning device and used to calculate their position. The sensors should have an accuracy of 0.1-0.2mm to ensure real-time tracking of the implant needle and particle positions during the implantation process.

[0037] In one embodiment, optical positioning markers can also be included: optical positioning markers are placed on surgical instruments (such as implant needles) and on the patient's body surface. An optical positioning system (such as an infrared optical tracking system) can be used to determine the marker's position by capturing the light reflected from the marker. This method can complement electromagnetic positioning, providing more accurate position information in environments with electromagnetic interference.

[0038] The particle implantation module mainly consists of two parts: an implantation needle system and a particle delivery device. The implantation needle can be a commonly used hand-held needle body. In one embodiment, the tip of the needle can be designed to be beveled or blunt with a side hole to facilitate puncture and particle release. The needle body has scale markings to facilitate the doctor to accurately grasp the insertion depth, and the scale accuracy is 1mm. An electric or manual implantation needle propulsion mechanism is also designed to accurately control the insertion speed and depth of the implantation needle. The electric propulsion mechanism can preset the insertion speed (such as 0.5mm / s) and depth, and has a real-time feedback function, which automatically stops when the preset depth is reached. The manual propulsion device is equipped with a fine adjustment knob, and the doctor can slowly advance the implantation needle according to the feel and image display.

[0039] The particle delivery device primarily consists of a particle storage chamber for storing particles. The internal environment must be sterile and dry. The chamber features a capacity indicator, accurately indicating the number of remaining particles. A tubing constructed of medical-grade silicone or other soft, sterile material connects the chamber to the implant needle to prevent contamination during particle delivery.

[0040] In one embodiment, a particle pushing mechanism may be provided, such as a pneumatic or mechanical screw-type pushing mechanism. Pneumatic pushing utilizes gas pressure to push particles individually into the implant needle, with adjustable pushing pressure to accommodate particles of varying sizes and materials. Mechanical screw-type pushing uses a rotating screw to push particles forward, offering greater precision and enabling precise control of particle spacing and release locations.

[0041] Through the above settings, the imaging and positioning module first images the patient's prostate area and constructs a three-dimensional model. Then, the particle implantation module, with the support of the three-dimensional model, accurately implants the particles into the designated position in the body. Due to the high precision of the three-dimensional model, the positioning of the particles during implantation is also highly precise. In addition, the positioning can be fed back and adjusted in real time. The implantation position of the particles can be stably controlled within the range of 0.5mm-1mm, which is a significant improvement compared to the conventional accuracy range of 2-5mm on the market. It also reduces the surgical intensity of the surgeon to a certain extent and reduces the difficulty of particle implantation and positioning.

[0042] However, due to the unique location of the prostate, it is easily affected by the patient's normal walking movements and inevitably squeezed by a full bladder, both of which can cause high-frequency displacement of the prostate. Therefore, this solution also includes a particle fixation module, which is primarily used to secure the particles to the tumor cells, mitigating the impact of high-frequency prostate movement on particle position and ensuring that the particles remain fixed relative to the tumor.

[0043] Specifically, in one embodiment, the particle fixation module refers to using biological glue to assist in fixing the particles. The biological glue has good biocompatibility and adhesion, and can solidify in a short time to adhere and fix the particles to the surrounding tissues.

[0044] In one embodiment, the bioglue is fibrin glue, which is primarily composed of fibrinogen, thrombin, calcium ions, and other components. During use, after fibrinogen and thrombin are mixed, the presence of calcium ions converts the fibrinogen into fibrin monomers, which then polymerize into fibrin polymers, forming a glue-like gel that can secure the thermotherapy particles in place.

[0045] Fibrin is a natural component of human blood, so fibrin glue has excellent biocompatibility and integrates well with human tissue, reducing immune and inflammatory responses. While securing the thermotherapy particles, it also provides a hemostatic effect, helping to minimize bleeding during surgery and lower the risk of postoperative complications. Fibrin glue is gradually degraded and absorbed in the body, eliminating the need for secondary surgical removal. It typically degrades completely within days to weeks, with degradation products such as amino acids, which are metabolized and excreted by the body.

[0046] In one embodiment, the bioglue is gelatin sponge, a porous, sponge-like substance made primarily from gelatin that, after special processing, forms a viscous colloid. It achieves a fixation effect by interacting with surrounding tissue and thermotherapy particles through physical adsorption and chemical bonding. The gelatin molecules in the gelatin sponge can form hydrogen bonds and van der Waals forces with biomolecules such as proteins on the tissue surface, thereby tightly binding the glue to the tissue.

[0047] Gelatin sponge has a certain degree of elasticity and flexibility, adapting to the shape and movement of tissue. When securing thermotherapy particles, it prevents them from easily falling out due to tissue movement, effectively maintaining the stability of the particles. Gelatin sponge provides an excellent scaffold for the growth of tissue cells, promoting the repair and regeneration of surrounding tissues. While securing thermotherapy particles, it also aids wound healing. It also absorbs exudate from surrounding tissues, maintaining a relatively dry environment, helping to prevent infection and creating favorable local conditions for the stable fixation of thermotherapy particles.

[0048] In one embodiment, the bioglue is chitosan glue, a natural polysaccharide derived from chitin via deacetylation. Chitosan glue dissolves in acidic conditions to form a viscous liquid. Upon contact with the tissue surface, chitosan gradually gels as the pH rises and water is absorbed, thereby securing the thermotherapy particles in place. Functional groups such as amino and hydroxyl groups in chitosan molecules can react chemically with biomolecules on the tissue surface, forming chemical bonds and enhancing the fixation effect.

[0049] Chitosan has certain antimicrobial activity, inhibiting bacterial growth and reproduction, reducing the risk of infection, and helping to maintain a sterile environment at the site where thermotherapy particles are implanted, ensuring treatment safety. It can also promote cell adhesion and proliferation, facilitating the growth of tissue cells around thermotherapy particles, further stabilizing their position and aiding tissue repair and regeneration. Furthermore, by chemically modifying chitosan or compounding it with other substances, its gelation time, mechanical properties, and degradation rate can be adjusted to meet the needs of different thermotherapy particle fixation locations and types.

[0050] The bioglue injection device can be directly integrated into the implantation needle or a special injection needle can be used to deliver the bioglue to the area around the particles.

[0051] In different embodiments, the particle fixing module refers to using heat to activate the adhesive material, and using an external magnetic field to stimulate the particles to generate heat to provide a heating source, so that the adhesive material solidifies, thereby achieving particle fixation.

[0052] In one embodiment, the adhesive material is poly (N-isopropylacrylamide) (PNIPAM), due to its low critical solution temperature (LCST), typically around 32°C. When the temperature is below the LCST, the hydrophilic groups on the PNIPAM molecular chain form hydrogen bonds with water molecules, extending the molecular chains and rendering the material hydrophilic and soluble in water. When the temperature is above the LCST, the hydrogen bonds break, enhancing the interactions between the hydrophobic groups, such as the isopropyl groups, on the molecular chains, causing the molecular chains to contract and transforming the material from a water-soluble state to a gel state, thereby achieving adhesion and fixation. Because its phase transition temperature is close to body temperature, heat-activated adhesion can be achieved without causing noticeable discomfort. Furthermore, it exhibits excellent biocompatibility and is less irritating to human tissue, reducing adverse reactions such as inflammation.

[0053] In one embodiment, the adhesive material is a gelatin-sodium glycerophosphate (Gel-GP) system. Gelatin is a natural protein with excellent biocompatibility and biodegradability. In the Gel-GP system, sodium glycerophosphate is negatively charged under physiological conditions and interacts with the positively charged regions in the gelatin molecules, forming a stable sol state at low temperatures. As the temperature rises, the thermal motion of the gelatin molecular chains intensifies, and interactions such as hydrogen bonds between the molecules are strengthened. Simultaneously, the interaction between the phosphate ions of sodium glycerophosphate and the gelatin molecules also changes, causing the system to transition from a sol to a gel, achieving adhesion and fixation. Furthermore, the gelation process is relatively mild, causing minimal damage to surrounding tissues. By adjusting parameters such as the ratio and concentration of gelatin and sodium glycerophosphate, the gel formation time and mechanical properties can be flexibly adjusted to suit different thermal therapy needs and tissue environments.

[0054] In one embodiment, the adhesive material is a sodium alginate-calcium chloride (SA-CaCl2) system. Sodium alginate is a natural polysaccharide extracted from seaweed, and its molecular chains contain numerous carboxyl groups. When a sodium alginate solution comes into contact with a solution containing calcium ions, the calcium ions undergo ion exchange with the carboxyl groups on the sodium alginate molecular chains, forming an "egg-box" structure that cross-links the sodium alginate chains, causing the solution to gel and secure the thermotherapy particles. During thermal activation, the increased temperature accelerates the ion exchange rate and promotes gel formation. Furthermore, it is widely available and relatively low-cost. It exhibits excellent biocompatibility and mechanical strength, maintaining good stability in the body and preventing the thermotherapy particles from dislodging during treatment. It can be used to secure thermotherapy particles in various tissues and organs, particularly in applications requiring rapid gelation for immediate fixation. For example, when placing thermotherapy particles in a residual cavity after tumor resection, the sodium alginate-calcium chloride system rapidly forms a gel, securing the particles in place and potentially preventing tumor recurrence.

[0055] In any of the aforementioned embodiments, the particle surface may be micro-textured, for example, by creating tiny bumps, depressions, or stripes using micro-nanofabrication techniques. These textures can increase friction between the particle and the surrounding prostate tissue, much like the tread pattern on a tire increases friction with the ground, making it more difficult for the particle to move within the tissue.

[0056] In one embodiment, the particles are designed to be non-spherical, such as dumbbell-shaped or with winged shapes. After implantation into prostate tissue, the irregular portions of the particles can better embed into the interstitial space, reducing displacement caused by external forces.

[0057] The magnetic field excitation module includes an excitation power supply, a first coil and a second coil. The first coil and the second coil are respectively located above and below the tumor to be hyperthermically treated, and the current in the first coil and the current in the second coil flow in the same direction.

[0058] The shape and structure of the first and second coils can be selected based on actual needs. For example, the first and / or second coils can be spiral coils or circular coils. The currents flowing in the first and second coils in the same direction can cause the magnetic fields of the two coils to overlap, thereby increasing the magnetic field strength.

[0059] The length of the line connecting the geometric centers of the first and second coils is 100-300 mm, and the magnetic field formed by the first and second coils forms an electromagnetic lens. The electromagnetic lens concentrates the magnetic lines of force within a channel with a diameter of 80-120 mm and a height of 60-100 mm, which overlaps the tumor to be hyperthermically treated.

[0060] The channel obtained by focusing the electromagnetic lens is a high-energy channel, which is conducive to efficiently and sensitively affecting the magnetic medium, thereby improving the heating efficiency and heating limit of the magnetic medium.

[0061] In one embodiment, in order to improve the stability of the electromagnetic lens constructed by the magnetic fields of the first coil and the second coil, the first coil and the second coil have the same phase.

[0062] In one embodiment, in order to improve the stability of the electromagnetic lens constructed by the magnetic fields of the first coil and the second coil, the first coil and the second coil are arranged in parallel.

[0063] In one embodiment, in order to improve the sensitivity of the temperature change of the magnetic medium, the projection of the first coil on the tumor to be hyperthermically treated and the projection of the second coil on the tumor to be hyperthermically treated at least partially overlap.

[0064] The projection of the first coil and the projection of the second coil on the tumor to be hyperthermia therapy refer to the projections of the first coil and the second coil on a plane perpendicular to the line connecting the geometric centers of the first coil and the second coil, and the geometric center of the tumor to be hyperthermia therapy is located on this plane.

[0065] In one embodiment, to further improve the heating efficiency and temperature limit of the magnetic medium, as well as enhance the sensitivity to temperature changes in the magnetic medium, the magnetic flux lines of the first coil and the second coil form a focused region within the electromagnetic lens. This focused region at least partially overlaps with the tumor to be hyperthermically treated. The focused region forms part of the channel. Typically, the focused region is constricted relative to the rest of the channel, giving the channel an hourglass-like shape.

[0066] In one embodiment, to enhance the stability of the electromagnetic lens formed by the magnetic fields of the first and second coils, the coil mechanism for thermal therapy further includes a first and second magnetic conductors. The first and second magnetic conductors may be made of metal. The first and second magnetic conductors are positioned above and below the tumor to be thermally treated, respectively, and the first and second coils are positioned on the first and second magnetic conductors, respectively. Specifically, the first and second magnetic conductors may be stainless steel rings.

[0067] In one embodiment, in order to improve the stability of the electromagnetic lens constructed by the magnetic fields of the first coil and the second coil, the first coil and the second coil are arranged in mirror symmetry.

[0068] In one specific embodiment, a coil mechanism for hyperthermia includes a first coil, a second coil, a first magnetic conductor, and a second magnetic conductor. The first magnetic conductor and the second magnetic conductor are located above and below the tumor to be hyperthermia treated, respectively, and the first coil and the second coil are located on the first magnetic conductor and the second magnetic conductor, respectively. The current in the first coil 1 and the current in the second coil flow in the same direction, the first coil and the second coil are in phase, and the first coil and the second coil are arranged in mirror symmetry. The projection of the first coil on the tumor to be hyperthermia treated completely overlaps with the projection of the second coil on the tumor to be hyperthermia treated. The length of the line connecting the geometric center of the first coil and the geometric center of the second coil is 200 mm, and the magnetic field formed by the first coil and the second coil forms an electromagnetic lens. The electromagnetic lens concentrates the magnetic lines of force within a channel with a diameter of 100 mm and a height of 80 mm. A focusing area is formed in the channel, and the tumor to be hyperthermia treated is located within the focusing area.

[0069] In one embodiment, the first coil and the second coil can also be arranged vertically left and right, and the patient stands between the two coils so that the tumor to be heat-treated is located in the channel of the electromagnetic lens formed by the magnetic field formed by the first coil and the second coil. Of course, according to actual conditions, the first magnet and the second magnet can also be installed on the same frame, and the frame can vertically translate the first magnet and the second magnet to lift and lower them, and open horizontally to separate the first magnet and the second magnet. By adjusting the position of the two coils, the size of the coil can be further made smaller. For example, in one embodiment, the diameter of the first coil and the second coil is 80-100mm, and the size of the magnetic channel formed by them is correspondingly smaller, but it can still completely cover the tumor area in the prostate.

[0070] Finally, the control and display modules are conventional contents in the prior art. The present invention does not involve changes to the specific software therein, so the contents of the module are not described in detail. For the completeness of this solution, the module can refer to the mature control and display solutions in the prior art, and no restrictions are imposed on it in this embodiment.

[0071] The present invention also proposes a method for positioning thermotherapy particles, such as Figure 1 As shown, it includes the following steps: An image of the treatment area is acquired to identify the tumor area, and a three-dimensional model of human tissue in the area to be treated is constructed using the image. The particle distribution position and implantation path are determined with reference to the three-dimensional model to obtain a particle implantation plan. The particles are implanted at the target location according to the implantation plan, and the actual fixed position of the particles is compared and reviewed. If the actual fixed position deviation exceeds a preset range, the position is corrected.

[0072] Specifically, a CT scan is performed first. The CT scan extends from the inferior margin of the pubic symphysis to the level of the ischial tuberosity, with a slice thickness generally set at 2-3 mm. This provides detailed cross-sectional images of the prostate and surrounding tissues. CT images can clearly demonstrate the size, shape, position, and relationship of the prostate to surrounding skeletal structures, providing a spatial reference for subsequent localization. Following the CT scan, an MRI scan is performed. MRI has higher resolution for soft tissue and can more clearly demonstrate the boundaries and internal structure of a prostate tumor, as well as its relationship to surrounding soft tissues such as nerves and blood vessels. Scanning sequences typically include T1-weighted, T2-weighted, and diffusion-weighted images. T2-weighted images can effectively delineate the structures of the peripheral and central zones of the prostate, helping to determine the approximate location of the tumor; diffusion-weighted images are more sensitive in detecting the density and active areas of tumor cells. By fusing MRI and CT images, the advantages of both can be combined to more accurately determine the tumor area. In one embodiment, an ultrasound probe is also included to observe the prostate and its internal structures in real time. Especially during transrectal ultrasound examinations, the probe is closer to the prostate, enabling a clearer visualization of prostate morphological changes. During the procedure, the doctor can adjust the probe position and angle based on the ultrasound image to obtain the optimal prostate image. They can also simulate the seed implantation path under ultrasound guidance to preliminarily determine the puncture point and direction. Of course, the image information collected by the ultrasound probe can also be used to fuse with MRI and CT images, combining the advantages of all three.

[0073] The resulting images are transmitted to the treatment planning system (TPS), where, through algorithms such as image registration and fusion, the three images are precisely superimposed. The TPS then performs a three-dimensional reconstruction of the prostate and tumor area, generating a three-dimensional model containing detailed anatomical information. This 3D model allows doctors to observe the relationship between the tumor and surrounding tissues from various angles, such as the distance between the tumor and the urethra, rectum, and neurovascular bundles.

[0074] Based on the size, shape, location, and treatment requirements of the tumor, TPS performs virtual planning for the distribution of radioactive particles. Physicians can determine the number, location, and depth of particle implantation on a three-dimensional model. TPS calculates the dose distribution around each particle based on the particle's radioactive properties, such as radiation energy and range, and further optimizes the particle distribution to ensure that tumor tissue receives a uniform and sufficient radiation dose while minimizing the dose to surrounding normal tissue. For example, for tumors in the peripheral zone of the prostate, the particle distribution density in the peripheral area will be appropriately increased to ensure that the tumor edge can also be effectively treated.

[0075] The seed implantation path is then simulated in TPS. Given the complex anatomy surrounding the prostate, including the presence of vital blood vessels, nerves, and internal organs, a safe and accurate puncture path must be planned. This path must avoid major blood vessels and nerves while minimizing damage to the urethra and rectum. By adjusting the puncture angle and depth, the implant needle accurately delivers the seeds to the intended location. During the simulation, TPS displays any collisions between the implant needle and surrounding tissue, allowing the physician to continuously optimize the path until the optimal solution is found.

[0076] In summary, the particle distribution plan and implantation path can be determined to obtain a complete particle implantation plan.

[0077] In another embodiment, imaging is re-performed to ensure accurate positioning. For example, cone-beam CT (CBCT) can be used to scan the patient in the operating room. CBCT can quickly obtain cross-sectional images of the patient in the surgical position and can be registered and compared with the planned images from the TPS. If a slight deviation in the prostate position is detected, the treatment table position or implantation plan can be adjusted promptly. Alternatively, intraoperative ultrasound can be used to observe the prostate and surrounding tissues in real time to confirm that the starting position and angle of the implant needle are consistent with the plan.

[0078] In another embodiment, to better determine placement during surgery, positioning reference points are marked on or within the patient's body, such as in the tissue surrounding the prostate. These reference points can be clearly visualized on imaging using small metal markers, such as gold labels, or special dyes. During seed implantation, the physician can further verify and fine-tune the placement by observing the relative position of these reference points, the implant needle, and the seed, ensuring accurate implantation.

[0079] Puncture is performed under imaging guidance, following the puncture point and path determined preoperatively. The needle is slowly advanced along the planned path, closely monitoring the imaging relationship between the needle and key structures such as the prostate tumor, urethra, and rectum. When the needle reaches the edge of the tumor, the correct position is reconfirmed and the needle is advanced to the predetermined depth. This depth is determined based on the particle distribution requirements of the treatment plan to ensure accurate placement of the particles within the tumor tissue.

[0080] Once the puncture needle is in place, the seed loading device delivers the radioactive seeds individually into the needle, and then pushes the seeds into the prostate tumor tissue. The seeds can be pushed manually or mechanically, and the pushing process should be smooth and slow to ensure uniform distribution of the seeds within the tumor tissue. During the implantation process, the seed spacing and distribution pattern specified in the treatment plan must be followed. For example, for larger tumors, seed implantation may require different layers and directions to ensure adequate radiation dose to the entire tumor area.

[0081] After each seed is implanted, the particle's location, including coordinates and depth, is recorded, and the distribution of the particle within the tumor tissue is observed. Imaging equipment can be used to verify that the particle distribution is as expected in real time. If the particle distribution is uneven or deviates from the intended location, the needle position must be adjusted or the seed implanted immediately.

[0082] After the particles are implanted, they are mainly fixed by the natural reaction of the tissue. The prostate tissue has a certain elasticity and self-repair ability. When the particles are implanted, the surrounding tissue will have a certain wrapping and adhesion effect on the particles. This natural fixation process gradually forms within a few hours to a few days after the particles are implanted. Of course, in the previous embodiments, there are schemes for local fixation using biological glue or absorbable fiber materials. In such schemes, these materials can be used to form a thin adhesion layer around the particles, which more closely binds the particles to the surrounding tissues, reducing the risk of particle displacement due to tissue activity in the early postoperative period, and also making the position of the particles relatively stable during the later treatment process.

[0083] Immediately after seed implantation, postoperative imaging studies are performed. These studies, typically performed using C-arm CT or ultrasound, examine the final position and distribution of the seeds within the prostate tumor from various angles. These images are then compared with the preoperative treatment plan to assess the accuracy of seed implantation. If significant deviations in seed placement or distribution are observed, remedial measures, such as additional seed implantation or seed position adjustment, are considered on a case-by-case basis.

[0084] In this specification, the use of terms such as "Embodiment 1," "this embodiment," and "in one embodiment" indicates that the specific features, structures, materials, or characteristics described in conjunction with that embodiment or example are included in the invention or at least one embodiment or example of the invention. In this specification, schematic representations of the above terms do not necessarily refer to the same embodiment or example; furthermore, the specific features, structures, materials, or characteristics described may be appropriately combined in any one or more embodiments or examples.

[0085] In the description of this specification, the terms "connect," "install," "fix," "dispose," and "have" are to be understood in a broad sense. For example, "connect" can mean a fixed connection, a detachable connection, or an integral connection; it can be a mechanical connection or an electrical connection; it can be a direct connection or an indirect connection through an intermediate medium, or it can be internal communication between two components. Those skilled in the art will understand the specific meanings of the above terms in this application based on specific circumstances.

[0086] In the description of this specification, relational terms such as "first" and "second" are used only to distinguish one entity or operation from another entity or operation, and do not necessarily require or imply any actual relationship or order between these entities or operations. Moreover, the terms "comprises", "comprising" or any other variations thereof are intended to cover non-exclusive inclusion, so that a process, method, article or apparatus comprising a series of elements includes not only those elements, but also other elements not explicitly listed, or elements inherent to such process, method, article or apparatus. In the absence of further limitations, an element defined by the phrase "comprising a ..." does not exclude the presence of additional identical elements in the process, method, article or apparatus comprising the element.

[0087] The above description of the embodiments is to facilitate ordinary technicians in this technical field to understand and apply the technology of this case. People familiar with the technology in this field can obviously make various modifications to these examples easily and apply the general principles described here to other embodiments without having to go through creative work. Therefore, this case is not limited to the above embodiments. Modifications to the following situations should all be within the scope of protection of this case: ① A new technical solution implemented based on the technical solution of the present invention and combined with existing common knowledge, the technical effect produced by the new technical solution does not exceed the technical effect of the present invention; ② The equivalent replacement of some features of the technical solution of the present invention with the known technology, the technical effect produced is the same as the technical effect of the present invention; ③ The technical solution of the present invention is expandable as a basis, and the substantive content of the expanded technical solution does not exceed the technical solution of the present invention; ④ The equivalent transformation made by the description of the present invention is directly or indirectly applied to other related technical fields.

Claims

1. A prostate tumor hyperthermia treatment device, comprising particles that generate heat under the action of a magnetic field, characterized in that: It also includes an imaging positioning module, a particle implantation module, a particle fixation module, a magnetic field excitation module, and a control and display module. The imaging positioning module includes a multimodal imaging device consisting of three equipment units: an ultrasound imaging unit, a CT scanning unit, and an MRI imaging unit. The multimodal imaging device uses at least two of the ultrasound imaging unit, CT scanning unit, and MRI imaging unit to construct a three-dimensional model of the prostate and tumor.

2. The hyperthermia device according to claim 1, characterized in that The imaging positioning module further includes an electromagnetic positioning sensor, which is located on the implanted needle and / or the particle and can respond to an external magnetic field for positioning.

3. The hyperthermia device according to claim 1, characterized in that The particle fixing module comprises a biological glue coating coated on the surface of the particles, and the biological glue is one of fibrin glue, gelatin sponge glue and chitosan glue.

4. The hyperthermia device according to claim 1, characterized in that The particle fixing module includes a heat-activated adhesive material coating coated on the surface of the particle. The heat-activated adhesive material undergoes a phase change when heated and adheres the particle to a target position.

5. The hyperthermia device according to claim 4, characterized in that The heat-activated adhesive material is one of poly (N-isopropylacrylamide), gelatin-sodium glycerophosphate, and sodium alginate-calcium chloride.

6. The hyperthermia device according to claims 1-5, characterized in that: The particle fixing module further includes a texture on the particle surface, wherein the texture includes ridges, depressions or stripes.

7. A method for positioning hyperthermia particles, characterized in that: It includes the following steps: An image of the treatment area is acquired to identify the tumor area, and a three-dimensional model of human tissue in the area to be treated is constructed using the image. The particle distribution position and implantation path are determined with reference to the three-dimensional model to obtain a particle implantation plan. The particles are implanted at the target location according to the implantation plan, and the actual fixed position of the particles is compared and reviewed. If the actual fixed position deviation exceeds a preset range, the position is corrected.

8. The positioning method according to claim 7, characterized in that: The method of acquiring an image of the treatment area and determining the tumor area, and then constructing a three-dimensional model of human tissue in the area to be treated by using the image, is specifically as follows: Two of the ultrasound imaging unit, CT scanning unit and MRI imaging unit are used to construct a three-dimensional model of the prostate and the tumor.

9. The positioning method according to claim 7, characterized in that: The particles are implanted at the target location according to the implantation plan, and the actual fixed position of the particles is compared and verified, specifically: A small metal marker or special dye marker is used to form a marking positioning reference point on the patient's body surface or body, and the actual fixed position of the particle is determined by observing the relative position relationship between the reference point, the implant needle and the particle.

10. The positioning method according to claim 7, characterized in that: The particles are fixed in the body by using biological glue material.

Images