A puncture navigation and real-time positioning sensor system for a brachytherapy needle for cervical cancer

Abstract

The application discloses a puncture navigation and real-time positioning sensor system for placing an interpolation needle for radiotherapy of cervical cancer, which comprises at least three reference targets with positioning sensors attached to a body surface; a wired or wireless positioning puncture needle, which is provided with a super-magnet sensor positioning device on a needle tip; a host computer imaging unit for displaying the imaging of the positioning puncture needle under CT; and a magnetic field generator for constructing a magnetic field space and positioning the magnetic sensor position. The puncture navigation process of the system comprises the following steps: laying a subject on an examination table, placing the at least three imaging units on the body surface of the subject, and performing CT scanning; connecting the positioning sensor to the imaging unit; starting the sensor to receive the position and attitude angle of the needle tip of the positioning puncture needle, combining the position of the imaging under CT from the host computer imaging unit with the coordinates of the positioning sensor, and performing registration of the magnetic field space and the CT space to realize path planning and navigation of the puncture position.

Description

Technical Field

[0001] This invention belongs to the field of clinical medical technology, and specifically relates to a puncture navigation system, a positioning reference target point, and a super-magnetic positioning puncture needle. Background Technology

[0002] Radiotherapy is suitable for all stages of cervical cancer. Because cervical cancer patients have a high tolerance to radiation dose, a high radiation dose is required to cure it, which cannot be achieved by conventional external beam radiotherapy alone. Due to the presence of natural cavities in the female body, cervical cancer is the most suitable cancer for brachytherapy.

[0003] Radiation therapy (RT), rapidly applied to cancer treatment after Röntgen's discovery of X-rays and Marie Curie's discovery of radium, has undergone over a century of development and remains one of the most important treatment methods for malignant tumors. RT is integrated into the entire cancer treatment process, with approximately 70% of patients requiring it, and 40% of these cases potentially curable with RT. The main forms of RT include external beam radiation therapy (EBRT) and brachytherapy. EBRT often employs conformal radiation therapy (3D-CRT) or intensity-modulated radiation therapy (IMRT), but due to dose limitations to normal organs, it often cannot achieve a cure on its own. Brachytherapy is an inside-out form of radiation therapy, often using Irradiation Reduction (IRR). 192 Co 60 High-dose-rate radioactive particles can create an effective high-dose zone within a relatively small area, offering good protection for normal tissues. They serve as an important means of local dose supplementation after external beam radiation and are widely used in the treatment of tumors in various systems throughout the body. Afterloading radiotherapy, a typical example of brachytherapy, can treat tumors of different sizes and shapes through intracavitary irradiation and / or interstitial irradiation. With radiotherapy entering the era of precision medicine, the status and advantages of afterloading radiotherapy have become increasingly prominent. Therefore, how to achieve precise afterloading radiotherapy to improve treatment efficacy and reduce toxic reactions has become a pressing clinical challenge. Summary of the Invention

[0004] One embodiment of this disclosure provides a cervical cancer multifocal puncture navigation system, comprising, At least three positioning reference targets, each containing at least one spatial marker; The positioning puncture needle is equipped with a super magnet positioning sensor, which can be wired or wireless; The main unit is used to develop images of the puncture site on the patient.

[0005] Here, superconducting magnets, as electromagnets using coils made from type II superconductors with high transition temperatures and exceptionally high critical magnetic fields at low temperatures, exhibit zero resistance and complete magnetic field repulsion at low temperatures. This allows superconducting magnets to generate very high magnetic field strengths within a relatively small volume. Superconducting magnets possess advantages such as strong anti-interference capabilities and small sensing unit size. Combined with gyroscope inertial navigation attitude parameters, they can continuously correct for time-varying deviations in micro-electro-mechanical systems (MEMS) technology. By utilizing AI technology to deeply fuse the data from both sources, more accurate navigation and positioning targets and effects can be achieved.

[0006] When the target with the imaging unit is a CT imaging unit, spatial markers are used as CT imaging markers. When the puncture site is located in the abdomen, the cervical cancer multi-lesion puncture navigation system of this disclosure is used to realize the abdominal puncture positioning and navigation process based on super magnets, gyroscopes and CT imaging markers for CT registration and angle correction. Attached Figure Description

[0007] The above and other objects, features, and advantages of exemplary embodiments of the present invention will become readily apparent from the following detailed description taken in conjunction with the accompanying drawings. Several embodiments of the invention are illustrated in the drawings by way of example and not limitation, wherein: Figure 1 A schematic diagram of the composition of a positioning reference target according to one embodiment of the present invention.

[0008] Figure 2 A schematic diagram illustrating the use of a positioning reference target according to one embodiment of the present invention.

[0009] Figure 3 Figure 2 A magnified view of a portion of point A in the middle.

[0010] Figure 4 A schematic diagram of a puncture navigation system according to one embodiment of the present invention.

[0011] Figure 5 A flowchart of a puncture navigation method according to one embodiment of the present invention.

[0012] Figure 6An example diagram of the puncture time according to one embodiment of the present invention.

[0013] 10 – Magnetic field generator; 20 – Operating table; 14 – Subject. 11—Location reference target 1, 12—Location reference target 2, 13—Location reference target 3, 15—Positioning puncture needle Detailed Implementation

[0014] Traditional puncture navigation suffers from problems such as the heavy burden on patients due to multiple CT scans, inaccurate positioning, and difficulty in detecting needle deviation. This disclosure aims to accurately locate the affected area in space while minimizing patient trauma through positioning sensors, and to promptly alert the surgeon to change direction when the needle deviates. Existing puncture navigation systems determine the puncture position by referring to previous CT images, involving spatial registration, but failing to achieve ideal spatial registration. Ideal spatial registration can construct a three-dimensional spatial system for human CT tracking, determine the relative relationship between surgical instruments and the patient, integrate preoperative CT models to guide surgical planning and real-time surgical guidance, and also enable visualization and real-time tracking of surgical instruments.

[0015] To address the aforementioned issues, this disclosure aims to accurately locate the spatial position of the affected area while achieving precise registration through multimodal image fusion, thereby reducing harm to the patient's body. Furthermore, by using a positioning sensor, it promptly alerts the doctor to change the direction of the puncture needle in the event of needle deviation.

[0016] The current puncture navigation process determines the puncture position based on previous CT images. A standardized guide plate is placed into the patient's natural orifice, and a universal support frame is placed under the patient's body with its head pointing towards the puncture site. A CT scan is then performed to determine the largest tomographic location of the lesion based on the CT images. Two positioning reference targets are placed on either side of the anterior hip bone, and a third is placed on the posterior hip bone. The puncture angle and path, including the puncture depth and target point, are determined by measuring the angle between the line formed by the needle insertion point and the affected area and the vertical line to the center of the earth. A step-by-step needle insertion method is then used. The first needle is inserted 8-10 cm subcutaneously, and its direction and position are observed. The second needle passes through the vagina and into the uterus until it reaches the lesion surface, and its direction is observed. The third needle is inserted above the affected area, with a depth of approximately 1 cm into the lesion.

[0017] This process involves spatial registration. Ideal spatial registration refers to constructing a three-dimensional spatial system for human CT tracking by locating a reference target, determining the relative relationship between surgical instruments and the patient during surgery, and integrating it with the preoperative CT model for display, effectively guiding surgical planning and real-time surgical execution. Simultaneously, spatial registration enables the visualization and real-time tracking of surgical instruments. However, current puncture techniques cannot achieve ideal spatial registration.

[0018] Because existing puncture-guided surgery has the following drawbacks: 1. The puncture path planning and registration of the cervical cancer insertion needle is very complex and requires doctors with many years of imaging experience to complete. The differences between doctors with different experience are significant. 2. Because the navigation path is very long, sometimes as long as 20 centimeters, blindly navigating it may cause deviations from the planned path; 3. The spatial location of the affected area needs to be determined using the guide plate position and multiple CT images, which takes a lot of time; 4. The spatial location of the affected area and the angle of puncture need to be determined manually, which may result in deviations; 5. Repeatedly turning on the CT scanner when determining the location of the affected area can have an impact on the patient's health. 6. The location of the largest tomographic segment of the lesion is determined solely by multiple CT images, and the determined location may not be the actual location of the largest tomographic segment. 7. If the puncture needle deviates, the doctor cannot detect it quickly and can only use CT images for calibration.

[0019] According to one or more embodiments, in order to solve the positioning and navigation problems in existing puncture procedures, this disclosure proposes a puncture navigation system, such as... Figure 4 As shown, the system includes, The positioning reference target is provided with at least three spatial markers, each with a different or identical standard geometric shape, such as a triangle, a circle, or a square. The use of three different geometrically shaped markers is to facilitate spatial matching. The positioning puncture needle is equipped with a gyroscope and a super magnet sensor locator, and the positioning puncture needle is fixed on the support of the guide plate of the operating table. Before the puncture navigation operation begins, the positioning puncture needle is fixed in the support guide plate. Since the relative spatial positions of the three spatial markers are known and determined, the positioning puncture needle also has an initial spatial coordinate position determined in space. The CT imaging unit is used to visualize the puncture site of the patient, and the spatial markers can be used as CT imaging markers.

[0020] The main components here are a gyroscope and a super-magnetic sensor. The gyroscope obtains the angular velocity of each axis, while the magnetic sensor obtains information about the surrounding magnetic field. The main task is to fuse the data from the three sensors to obtain relatively accurate attitude information. It is worth noting that the positioning sensor unit provides relative positioning information; its function is to measure the path of motion relative to the starting object.

[0021] The puncture navigation process of this system includes, The patient lies on the operating table, and the puncture positioning needle is placed on the guide plate support of the operating table. The detector of the imaging unit illuminates the area to be punctured; Remove the positioning puncture needle from the guide plate support and align it with the intended puncture site; The system receives the attitude angle and position information of the sensor locator on the positioning puncture needle, and combines it with the image obtained from the display unit to realize path planning and navigation of the puncture position.

[0022] In the embodiments disclosed herein, such as Figure 1 , 2 As shown in Figure 3, to obtain an initial and fixed spatial coordinate, at least three reference targets with markers are placed at the location of the bony structure of the human body. The role of the markers is to accurately and quickly generate the spatial position of the affected area by computer, which can reduce the workload of doctors. Here, the three markers can be called "CT imaging markers". Each of these three spatial markers has a different standard geometric shape, which can be a triangle, a circle, or a square. Due to the obvious difference in shape, different markers can be extracted using a simple feature extraction algorithm in image reconstruction and recognition, and their corresponding coordinates can be located, thereby reducing the amount of calculation and speeding up the calculation. At the same time, since the relative distance and position of the three markers are fixed and known, a navigation spatial reference system is established by the coordinates of the three markers and the surface determined by the three points. In this reference system, the spatial path data of the positioning puncture needle with positioning sensor is obtained, which enables precise positioning control and path planning of the puncture path, such as... Figure 1 As shown.

[0023] Three CT imaging markers are fixed to the body, and a slot is designed on the guide plate support specifically for placing and securing the puncture needle with a positioning sensor. Since the three CT imaging markers are fixed to the bony structures of the body, such as... Figure 1 As shown, the doctor can know the location of three CT imaging markers in actual space. A positioning sensor is designed to be implanted at the tip of the puncture needle. After inserting the puncture needle with the positioning sensor into the slot of the guide plate holder, the puncture needle will be fixed on the holder, and then the guide plate will be placed between the thighs of the affected area.

[0024] The guide plate support uses a slightly rigid material to prevent deformation that could lead to measurement errors. Since the positioning sensor is fixed to the guide plate support, its spatial position is also known. A CT scan of the patient's affected area allows the doctor to determine the nodule's actual physical location, the required puncture angle, and the puncture path. Simultaneously, the CT scan captures three landmarks, which are segmented using deep learning to determine their positions on the CT image. Here, the puncture navigation system's data processing computer, connected to the CT scanner's image data output port, receives the CT image data containing the actual spatial positions of the three CT landmarks. Combined with the simultaneously received positioning trajectory data of the puncture needle, puncture registration is performed. This process includes establishing coordinates using the three CT landmarks, initializing the positioning sensor to obtain its initial position, and calculating the required angle transformation of the positioning sensor to match the planned puncture path, thus guiding the puncture operation on the patient. Before the puncture procedure begins, a CT scan of the patient's body is taken, and the puncture needle with a positioning sensor is pulled out of the slot of the guide plate holder to begin puncture at the intended puncture site.

[0025] Specifically, the registration process here includes the following steps: 1. The data processing computer of the puncture navigation system acquires CT data; 2. The CT image is automatically segmented using a feature extraction algorithm, resulting in three markers. The coordinates of the markers in actual space are known, as are their relative positions with the positioning sensor. At this point, the position of the positioning sensor in the CT image can be calculated. The patient's tumor area is identified manually or using an image recognition algorithm, and a puncture path is set. This puncture path is linear, and the coordinates of two points need to be set: the needle insertion point and the target point. The needle insertion point is on the guide plate support. 3. The coordinates of the two points mentioned above, the coordinates of the needle entry point and the target point, are calculated and then transmitted back to the positioning sensor; 4. At this point, the positioning sensor knows the target angle and begins to provide angle and position alerts. Two thresholds can be set here: 1° and 5°. If the tilt angle of the puncture needle is within 1 degree, the positioning sensor displays a green light.

[0026] Since the three markers are fixed to the abdominal bones of the human body, and are designed with different shapes, image recognition can be performed more quickly. In this way, spatial positioning can be performed rapidly using the markers.

[0027] When the positioning needle is initially fixed to the guide plate's support, its initial spatial position is determined. The patient's usual position on the puncture operating table is supine.

[0028] According to one or more embodiments, a puncture surgery navigation system is provided. The system includes, The guide plate aiming support has a bracket for placing the puncture needle; A positioning puncture needle is equipped with a gyroscope and a super magnet sensor locator. The imaging host unit is used to visualize the puncture site of the examinee.

[0029] The positioning puncture needle has a positioning point inside the guide plate aiming support.

[0030] The puncture navigation process of this system includes, Have the patient lie on the examination table and place the positioning support on the patient's intended puncture site; The detector of the imaging unit illuminates the area to be punctured; The positioning puncture needle is pulled out from the positioning point of the guide plate aiming support and directed toward the intended puncture site; The attitude angle of the gyroscope locator on the positioning puncture needle is received, and combined with the image obtained from the display unit, the path planning and navigation of the puncture position are realized.

[0031] After the puncture procedure begins, the gyroscope and magnetic sensor continuously transmit data to the system's navigation data processing computer. The computer program continuously analyzes the data from the gyroscope and magnetic sensor, transforms it into the coordinate system of the real human body, and tracks the current angle and position in real time, matching it with the preset path. Accumulated errors from the gyroscope and magnetic sensor are eliminated through filtering and other methods. The puncture navigation system, through a set reminder device, can provide real-world guidance on the path planned by the CT scan. The position of the puncture needle is also displayed in the CT image space. Based on the CT data, the system reconstructs a three-dimensional coordinate space, and the puncture needle is simultaneously displayed in this space. Here, the CT scanner is one type of imaging unit device in the system; the navigation data processing computer can also be connected to other types of human imaging data scanning equipment, including MRI equipment, or other devices that can acquire real-time internal human imaging data.

[0032] Here, two thresholds can be set: 1° and 5°. If the tilt angle of the puncture needle is within 1 degree, the gyroscope locator displays a green light. If the deviation angle is between 1 and 5 degrees, the puncture positioning needle flashes a yellow light and emits an alarm sound. If the deviation angle is greater than 5 degrees, it flashes a red light and emits an alarm sound. A step-by-step needle insertion method is then used. The first needle is inserted 6-8 cm subcutaneously, and the direction of the needle is observed. The second needle passes through the vagina and enters the uterus until it reaches the uterine surface, and the direction of the needle is observed again. The third needle is inserted above the affected area and quickly penetrates about 1 cm into the uterine wall. The fourth needle is inserted until it is flush with the affected area. During the puncture process, multiple CT scan images of the body may be acquired as needed.

[0033] like Figure 5 As shown, the puncture navigation process includes the following steps: 1. Secure the gyroscope and magnetic sensor positioner to the puncture needle using the clamp. Activate the gyroscope and magnetic sensor devices on the puncture needle and insert the puncture needle into the slot of the guide plate aiming holder. Place the guide plate aiming holder and have the patient lie down. 2. CT scan to determine the location of the affected area, use algorithm to segment the CT imaging markers in the positioning tray and perform spatial registration. At this time, the relative positions of the puncture needle and the CT imaging markers in the three reference targets are known. 3. The doctor plans the puncture path and transmits the path data to the gyroscope and magnetic sensor device; 4. The doctor removes the puncture needle from the slot in the guide plate aiming holder and performs the puncture according to the light prompts from the gyroscope and magnetic sensor device; 5. Puncture completed.

[0034] The technical solution disclosed herein can measure the spatial orientation of the affected area more accurately and quickly, and use a gyroscope and magnetic sensor locator indicator light to prompt the doctor on the deviation angle and planned path of the puncture needle insertion, so as to accurately align the puncture needle with the intended puncture site.

[0035] The navigation system disclosed herein places the abdominal puncture needle in the guide plate aiming holder. After determining the initial spatial position, the abdominal puncture needle is removed from the positioning holder, and three CT image markers are placed in the positioning holder. A CT scanner or other type of real-time or non-real-time internal human imaging equipment is used to collect human image data and upload it to a computer. The computer precisely determines the spatial position of the affected area, and a puncture needle with a sensing unit is attached to the puncture needle. The system monitors the deviation angle and position of the puncture needle from the initial position in real time, dividing it into three ranges. If the tilt angle of the puncture needle is within 1 degree, the locator with the sensing unit displays a green light. If the deviation angle is 1 degree, the locator with the sensing unit flashes a yellow light and emits an alarm sound. If the deviation angle is greater than 5 degrees, it flashes a red light and emits an alarm sound.

[0036] Compared to traditional methods, the method disclosed herein is more accurate and real-time because using CT imaging markers to determine the spatial location of the affected area is faster and more efficient than the traditional method of determining the spatial location of the affected area based on multiple CT images. In traditional puncture navigation surgery, once the puncture needle deviates, multiple CT scans are required to detect and recalibrate it. However, in this project, a locator that integrates a gyroscope and a super-magnetic sensor can quickly detect deviations, allowing doctors to identify and calibrate them promptly.

[0037] It should be understood that in the embodiments of the present invention, the term "and / or" is merely a description of the relationship between associated objects, indicating that three relationships can exist. For example, A and / or B can represent: A existing alone, A and B existing simultaneously, and B existing alone. Furthermore, the character " / " in this document generally indicates that the preceding and following associated objects have an "or" relationship.

[0038] The above description is merely a specific embodiment of the present invention, but the scope of protection of the present invention is not limited thereto. Any person skilled in the art can easily conceive of various equivalent modifications or substitutions within the technical scope disclosed in the present invention, and these modifications or substitutions should all be covered within the scope of protection of the present invention. Therefore, the scope of protection of the present invention should be determined by the scope of the claims.

Claims

1. A puncture navigation and real-time positioning sensor system for placing radiotherapy insertion needles in cervical cancer, characterized in that, The system includes, Reference positioning target, at least three positioning sensors attached to the body surface to position the target; Wired or wireless positioning puncture needles, with a super magnet sensor locator on the needle tip, and multiple positioning puncture needles can simultaneously complete the imaging and navigation function within the system. The main imaging unit is used to process image data and display the positioning sensor images under CT. A magnetic field generator is used to construct a magnetic field space and locate the position of a magnetic sensor.

2. The puncture positioning, planning, and navigation system according to claim 1, characterized in that, The host imaging unit is connected to the reference positioning target, so that the reference positioning target connected to the host imaging unit is in the same position in the magnetic field space and the CT space.

3. The puncture positioning and navigation system according to claim 2, characterized in that, The puncture navigation process of this system includes, The patient lies on the operating table, and the reference positioning target is placed on the patient's body surface. Connect the positioning puncture needle to the main imaging unit; The positioning puncture needle is fixed to the target sheath of the guide plate device on the operating table and aligned with the intended puncture site; The system receives the position and orientation angle of the positioning puncture needle, and combines this information with the image obtained from the host imaging unit to achieve path planning and navigation for the puncture site.

4. The puncture navigation system according to claim 3, characterized in that, At least three reference targets should be placed on the patient.

5. The puncture navigation system according to claim 1, characterized in that, Used for imaging and irradiation of positioning reference targets. Preferably, the host imaging unit is a CT imaging unit, which can display the position of the positioning reference target in the CT scan and register it with the three-dimensional space of the positioning sensor.

6. The puncture navigation system according to claim 1, characterized in that, The positioning reference target has a standard geometric shape. Preferably, each positioning reference target has a different standard geometry.

7. The puncture navigation system according to claim 1, characterized in that, The positioning sensor is placed at the tip of the puncture needle.

8. At least three positioning reference targets, characterized in that, The distance to the reference target is greater than ten centimeters. The positioning reference target is used in the puncture navigation process, and the positioning reference target is used in the following way: The patient lies on the examination table, and the positioning reference target is placed on the patient's body and visualized under CT. The positioning reference target is scanned along with the human body using a CT scan. Connect the positioning reference target to the main unit developing unit; The positioning puncture needle is taken out from the target sheath of the operating table fixing guide device and aligned with the intended puncture site; By combining the position of the positioning reference target in CT imaging with the coordinates of the positioning reference target, the magnetic field space is registered with the CT space to achieve path planning and navigation of the puncture site.

9. The positioning reference target according to claim 8, characterized in that, The positioning reference targets are multiple, and each target has a different geometry.

10. A positioning puncture needle, characterized in that, The puncture needle tip has a positioning sensor, and multiple puncture needles with positioning capabilities can simultaneously plan paths and navigate under system guidance, for use in the puncture navigation system as described in claim 1.

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