WO2008028354A1

WO2008028354A1 - Permanent magnetic resonance image-guided vitro high intensity focused ultrasound system and method

Info

Publication number: WO2008028354A1
Application number: PCT/CN2006/003266
Authority: WO
Inventors: Ming Zhao; Xiaodong Wu
Original assignee: Beijing Yuande Bio-Medical Engineering Co., Ltd.
Priority date: 2006-08-25
Filing date: 2006-12-04
Publication date: 2008-03-13
Also published as: CN100425199C; CN1903121A

Abstract

A magnetic resonance imaging system with a horizontal field permanent magnet used in cooperation with a high intensity focused ultrasound treating system out of body includes a permanent magnet subsystem, a gradient subsystem, a radiofrequency subsystem, an upper focused ultrasound transmitter subsystem, a lower focused ultrasound transmitter subsystem, a subject support positioning subsystem used in cooperation with the upper focused ultrasound transmitter subsystem, a subject support positioning subsystem used in cooperation with the lower focused ultrasound transmitter subsystem, and a computer and image processing subsystem. The permanent magnet subsystem adopts a magnet of U-shaped configuration. The structural features of the U-shaped permanent magnet consist in: creating a relatively large ellapsoidal sample area with uniform magnetic field around its center, a channel-type magnetic gap with a penetrated back and front and an open top and bottom, a large available magnetic gap distance and a maximal available field intensity.

Description

Permanent magnetic resonance image guidance

High energy focused ultrasound system and method

The invention belongs to the field of medical imaging diagnosis and interventional treatment instruments and devices, and relates to a magnetic resonance imaging (MRI) guided diagnosis and interventional treatment technology, High Intensity Focused Ultrasound (hereinafter referred to as HIFU). ) Treatment technology.

More particularly, the present invention relates to an in vitro high energy focused ultrasound therapy system for image guidance and treatment process monitoring and efficacy examination using a high openness permanent magnetic resonance imaging system and a method of using the same. Background technique

BACKGROUND OF THE INVENTION

The in vitro high-energy focused ultrasound therapy system is to accumulate super-energy in vitro in the deep target tissue of the human body to achieve precise thermal damage to the selected target tissue. At present, the in vitro high-energy focused ultrasound therapy system is one of the hotspots of medical research at home and abroad, and clinical applications have achieved good results. In vitro high-energy focused ultrasound has been shown to be useful in the treatment of tumors and diseases in the liver, kidney, pancreas, rectum, prostate, breast, bone, skin, uterus, etc. Among them, transrectal treatment for prostate cancer is the most extensive. In the clinical application of high-energy focused ultrasound tumor therapy technology, Chinese medical workers have done a lot of work in the domestic liver cancer, kidney cancer, breast cancer and uterus since the 1990s. The field of treatment such as fibroids has accumulated valuable clinical experience and has attracted the attention of the world's peers.

The common in vitro high-energy focused ultrasound therapy system generally consists of the following components: a transmitter for generating high-energy focused ultrasound and its driving circuit; a real-time image inspection and monitoring system for finding a target area of treatment (mostly Β-type ultrasound imaging) Check According to the results of real-time image examination, the focused ultrasound transmitter multi-degree-of-freedom attitude control system that moves the treatment target area to the focused focal region and the patient (also called the examinee or the subject to be examined) are in a suitable treatment position. Bed system; system operation console; high energy focused ultrasound conducting structure and conductive medium processing system. The high-energy focused ultrasonic conducting structure is mainly provided with a closed water tank, a closed water tank or a water tank having an overflow function for accommodating degassed purified water as a conductive medium in front of the high-energy focused ultrasonic emitting surface. The conductive medium treatment system is a complete set of equipment for supplying degassing purified water to the above-mentioned closed water tank, closed water tank or overflow tank with overflow function, including water source, degassing treatment device, water purification treatment device, filtration treatment device, and transportation pipeline System, etc. Background Art 2:

Multi-array phase-controlled array (Phase Array) high-energy focused ultrasound transmitter, which is characterized by its multi-array spherical phased array high-energy focused ultrasound transmitter, multi-array arc-faced phased array high-energy focused ultrasound transmitter And a plurality of types of phased array type high energy focused ultrasound transmitters, such as a multi-element planar phased array type high energy focused ultrasound transmitter.

The main feature of phased array focused ultrasound transmitters is the ability to produce flexible, variable single focus and simultaneous multi-focus focus modes for treatment. Compared with the single-element single-focus point, multi-point focusing can increase the single treatment focus volume, greatly reduce the treatment time, and speed up the treatment. Phased array focused ultrasound transmitters can also be treated with sub-array techniques to avoid obstacles such as ribs.

Compared to common non-phased arrayed focused ultrasound transmitters requiring complex multi-degree of freedom attitude control, multi-element phased array high-energy focused ultrasound transmitters are required for multi-positional therapy of patients. The number of movement axes is small, the posture control unit is single, and the treatment time is greatly shortened. The number of parts and components used to manufacture the motion mechanism is small, and the parts are structurally simple, and all non-metallic and non-magnetic materials can be used. It is manufactured to meet its requirements for use in a magnet environment. BACKGROUND ART 3:

A common permanent magnet magnetic resonance imaging system generally consists of several subsystems: a magnetic subsystem, a gradient subsystem, a radio frequency subsystem, a computer and image processing subsystem, a patient-bearing positioning subsystem, and a scanning subsystem.

The permanent magnet is designed with a magnetic gap space extending in the front-rear direction, the upper-lower or the left-right direction, and a uniform magnetic field sample area placed in the magnetic gap space; the gradient subsystem includes a gradient line for generating a gradient field and A matching gradient power system, a gradient line heat dissipation system, a noise absorption control system, and the like; the RF subsystem includes two parts, an RF transmission and an RF reception, including an RF transmission line for implementing RF excitation and a power supply system associated therewith. Radio frequency signal receiving line for receiving magnetic resonance imaging information and its associated signal processing system; computer and image processing subsystem including spectrometer subsystem for data acquisition, image reconstruction subsystem, host computer, operation console, etc. The patient bearing positioning subsystem includes an examination bed I inspection chair for carrying the patient for scanning positioning and scanning motion requirements; the scanning subsystem includes an electromagnetic shielding scanning room and an inter-scanning signal system, internal and external communication, monitoring system, and the like.

The U-shaped permanent magnet of the present invention is different from the common medium-low field strength and vertical field arrangement permanent magnet system in that the permanent magnet of the ϋ-type arrangement has a magnetic field in a horizontal state arrangement, and the patient The upper and lower sides of the body are highly open. Compared with the existing ϋ-type structure and horizontal field arrangement magnet, the difference is that it is specially designed and manufactured to work with the upper and lower emitters of high-energy focused ultrasound, and has the advantages of large gap size. Compared with the existing magnetic resonance guided high energy focused ultrasound equipment, it differs in that it uses a medium and low field strength permanent magnet rather than a high field strength superconducting magnet. The magnet has a high degree of openness and good amenity, and is suitable for upper and lower two high-energy focused ultrasonic transmitters. BACKGROUND ART 4:

At present, the in vitro high-energy focused ultrasound therapy system for clinical application is used to perform image guidance with a B-type ultrasound imaging imager, and the B-mode ultrasound image is used to find a treatment target area, perform real-time image examination, and monitor the treatment process. Limited to the shortcomings of the existing B-mode ultrasound imaging ultrasound technology in real-time guidance and accurate diagnosis, the use of magnetic resonance imaging system for image guidance and treatment process monitoring, efficacy examination, has become the main development of in vitro high-energy focused ultrasound therapy system technology direction.

The reason why magnetic resonance guided in vitro high-energy focused ultrasound therapy system has become the development direction of a new generation of in vitro high-energy focused ultrasound therapy system is mainly based on the advantages of magnetic resonance equipment in real-time image guidance, non-invasive temperature measurement and accurate diagnosis of clinical tumors. Mainly in the following points:

(1) Magnetic resonance imaging is superior to ultrasound imaging in image detection

Magnetic resonance imaging is a safe, non-invasive tumor imaging diagnostic device that uses a variety of pulse sequence imaging to comprehensively observe the pathological changes of tumor lesions. Accurate 3D high resolution images with resolutions up to 1mm. The image is clear and accurate, especially for the boundary between the tumor site and the surrounding normal tissue. Magnetic resonance Using the characteristics of benign tumors and malignant tumors in the blood supply, dynamic enhancement scans can be performed to observe the ratio of lesion signal enhancement, and the sensitivity and specificity of malignant tumor diagnosis are about 95%. Magnetic resonance uses RF transmit and receive coils during the test, but does not directly contact the patient's body. The interference factors encountered during the inspection process are relatively small, the image reproducibility is very good, and the image quality is stable.

Most of the commonly used B-mode ultrasound imaging instruments can only provide two-dimensional images, and the resolution is not as clear as magnetic resonance. Some subtle parts of the tissue of the lesion are not easily seen. Ultrasound images are easily affected by factors such as bones and gases in the human body. The detection must take into account the human body's position, posture, positional state, the fit between the ultrasound probe and the skin, the angle of the probe, and other factors. Because of many interference factors, the image quality is unstable during the ultrasonic real-time detection process. (2) Magnetic resonance imaging is superior to ultrasound imaging in real-time guidance

At present, in vitro high-energy focused ultrasound therapy systems, the control of the spatial position of the focus point is obtained by focusing the motion of the ultrasound transmitter. The focused ultrasound used in in vitro high-energy focused ultrasound therapy systems is three-dimensional energy focusing. That is, in one detection cycle, the high-energy focused ultrasonic transmitter is used to focus the emitted energy, and after stopping, the two-dimensional image guided ultrasound is used to detect the treatment site, and an image reflecting the therapeutic effect is obtained. One detection cycle is followed by another detection cycle, which is repeated. In one detection period, the time for focusing the emission of the high-energy focused ultrasound transmitter is generally long and the time for two-dimensionally guiding the ultrasonic detection image is short. In the actual working process, the interference between the three-dimensional energy focused ultrasound and the two-dimensional image guided ultrasound is serious, some images do not really reflect the therapeutic effect, and the two-dimensional image guided ultrasound does not reach the real real-time guidance.

The magnetic resonance imaging examination process is different from the principle of the energy emission process of focused ultrasound, and does not interfere with each other during operation. The imaging speed of the fast pulse sequence of magnetic resonance is relatively fast, especially for a small region of interest (ROI), which can quickly and accurately observe and judge the therapeutic effect of the focal region, which is beneficial to the irreversible phase change (cell necrosis) of tumor tissue. evaluation of. Magnetic resonance can interactively control the energy and duration of the high-energy focused ultrasound focal region in real time. Achieve the purpose of destroying the tumor tissue without damaging the surrounding normal tissue.

Magnetic resonance provides focus position monitoring and ultrasound energy control during magnetic resonance guided in vitro high-energy focused ultrasound therapy systems. When the energy at the focus is relatively low, there is only a slight temperature rise, and the resulting magnetic resonance image can guide the focus on the tumor tissue. After the focus is positioned, the ultrasound energy is increased and the tumor cells are killed. Tumor cells are denatured by tissue after thermal coagulation. After reaching a certain temperature, the water in the tissue is vaporized, resulting in changes in tissue density and other properties. Magnetic resonance imaging is sensitive and clear, capturing and reflecting these changes quickly and accurately. Multiple ways to extract information and monitor in real time.

(3) Real-time non-invasive temperature measurement, magnetic resonance is better than ultrasonic temperature measurement Magnetic resonance imaging parameters (such as Tl, diffusion, and chemical shifts) are sensitive to changes in tissue temperature and provide real-time, three-dimensional, high-resolution images of temperature changes during thermal action. When the temperature exceeds 41 ° C, magnetic resonance can record the signal of tissue protein denaturation (coagulation). A measure of the instantaneous temperature of normal tissue around the target is achieved. The temperature measurement of the magnetic resonance equipment is very sensitive, the temperature measurement accuracy can reach rc, and the information of the accurately reflected temperature field distribution can be obtained. Ultrasound is currently difficult to do this. BACKGROUND OF THE INVENTION 5:

U.S. Patent No. 6,582,381 B1, entitled "Mechanical Positioning Device for Magnetic Resonance Imaging Guided Ultrasound Therapy System", proposed by Insecec-Texix Corporation, which discloses under-mounted high energy focusing for use in a magnet environment Ultrasonic transmitter and its compact multi-degree-of-freedom attitude motion and control mechanism, high-energy focused ultrasonic transmission device structure design, introduces the mechanism driven by piezoelectric vibration motor and its use in magnetic field environment. However, this patent uses cartridge magnetic resonance imaging, which limits the space of the examination object, so that it is not possible to arrange the ultrasound treatment facilities more effectively (such as placing more than one launch probe), nor does it propose to use a high-energy focused ultrasound transmitter in a magnet environment. More effective measures or improvements. Summary of the invention

The present invention provides an in vitro high-energy focused ultrasound tumor system and related implementation method for image guidance and treatment process monitoring and efficacy examination using a high-openness permanent magnetic resonance imaging system.

In summary, the present invention relates to system design: a 0.35T / 0.45T permanent magnet high openness horizontal field magnetic resonance imaging system using a U-shaped structure. Combining permanent magnets, gradient coils, RF receiving/transmitting coils, high-energy focused ultrasound transmitters, patient (inspected or inspected) bearing positioning devices (inspection beds or chairs) into an integrated system, composite real-time Image inspection, tumor treatment, temperature control and other functions. W uses a phased array focused ultrasound transmitter combined with real-time visualization of damaged tissue to reduce the number of repeated treatments required by the patient and reduce treatment time. Real-time scanning imaging was performed using preoperative and intraoperative magnetic resonance rapid sequences to clearly observe changes in the lesion site in real time. The temperature information of the treatment site is extracted from the parameters of magnetic resonance imaging (such as Tl, diffusion and chemical shift, etc.), and the treatment process is precisely controlled.

In summary, the present invention realizes the integration of image guidance and treatment process monitoring, efficacy examination and treatment, and exerts the respective advantages of different systems. The invention comprises a complete permanent magnet high-openness magnetic resonance imaging system and a set of high-energy focused ultrasound treatment system (including upper and lower focused ultrasound emission) matched with the magnetic resonance imaging system. , including a number of specially designed subsystems that link the functions of both sides.

The main subsystems of the apparatus of the present invention are: a permanent magnet system for creating a uniform magnetic field sample zone; a gradient subsystem for generating a gradient field in the sample zone; and a radio frequency field for activating the object to be inspected The RF subsystem of the target level; the upper focused ultrasound transmitter subsystem comprising the upper high energy focused ultrasound transmitter; the lower focused ultrasound transmitter subsystem comprising the lower high energy focused ultrasound transmitter; the inspected with the upper focused ultrasound transmitter An object bearing positioning subsystem; an object to be inspected to be positioned with a lower focused ultrasound transmitter; and a computer and image processing subsystem,

In addition, it can also include an upper/lower focused ultrasound transmitter multi-degree of freedom attitude control subsystem, a high energy focused ultrasound conducting structure and a conductive medium processing subsystem, and a scanning subsystem.

According to the requirements of the Cartesian coordinate system, the coordinate system of the composite system is set as follows: The X-axis and the ζ-axis plane of the system correspond to the patient's cross-section (Axial Plane), the system's y-axis and z-axis plane correspond to the patient sagittal plane ( Sagittal Plane ), the system's X-axis and y-axis planes correspond to the patient's Coronal Plane.

In a specific embodiment, the entire system includes the following specific technical features: The structure of the permanent magnet of the u-shaped structure is: a u-shaped high open magnet structure arranged with left and right magnetic poles, the yoke is composed of a left yoke, a right yoke, and a bottom yoke, and the left yoke and the right The side yoke is arranged symmetrically to the bottom yoke, and the bottom yoke is the base of the entire magnet; the right magnetic yoke (N pole) is located on the left side of the right 辄 iron, and the left side 垛 (S pole) is located on the left side. On the right side of the yoke, the two magnetic yokes are parallel to each other; the magnetic flux is emitted by the magnetic yoke on the right side, passes over the magnetic gap space between the two cymbals, penetrates the magnetic yoke on the left side, and returns to the magnetic yoke on the right side by the bottom yoke, forming Closed loop

A first and a second gradient line 布置 are arranged on a side of the magnet on the right side of the magnet and a side of the left side of the magnet, and the two gradient coils are parallel to each other; the gradient line is designed and manufactured according to the gradient magnetic field distribution and the gradient field strength requirement. Compatible with the enlarged magnetic gap size between the magnetic poles.

A ϋ-type arrangement permanent magnet having a large gap of available magnetic gap, high magnetic field strength, no eddy current, high openness, etc., characterized in that the magnetic yoke is composed of a single type of permanent magnet material. Different grades of sintered NdFeB, samarium-cobalt alloy, etc. can be used for the permanent magnet material. On the basis of ensuring the required maximum available magnetic gap spacing, maximum available field strength and maximum size uniform magnetic field sample area, the realization of the magnetic field is ensured by the selection of permanent magnet materials, the design of the magnet structure, and the manufacturing technology.

The U-shaped permanent magnet system is specifically designed to match the clinical application and development of the high-energy focused ultrasound tumor treatment system and the accompanying requirements. For U-shaped permanent magnets, regardless of their current specific magnet structure, type and grade of permanent magnet materials, manufacturing process technology, regardless of possible future technological developments and technological breakthroughs, as long as the following four The condition is the magnet that meets the requirements.

These four conditions are: that is, to create a large-sized ellipsoidal uniform magnetic field sample region in its own center, a channel-type front-rear penetration, an open upper and lower magnetic gap space, a large-sized available magnetic gap space, and Maximum available field strength.

U-shaped permanent magnets placed in the center of the electromagnetic shielding scanning The permanent magnet is designed with a magnetic gap space extending in the front-rear direction (along the y-axis of the system), upper and lower (along the z-axis of the system), and an ellipsoid-shaped uniform magnetic field sample area placed in the magnetic gap space. The direction from the N pole to the S pole is the same as the negative direction of the X axis of the system. The two gradient lines and their temperature control devices are symmetrically disposed in the magnetic yoke on the left and right sides of the magnet, and the available gap between the magnetic poles is preferably 600 mm. The entire magnet is designed with no eddy current technology and has a high degree of openness.

In one embodiment, the ellipsoidal uniform magnetic field sample region of the permanent magnet is characterized in that it has a space size that satisfies the use requirement (the three ellipsoid values of the ellipsoid are 400 mm, 400 mm, and 380 mm, respectively), and can accommodate The upper and lower phased array high-energy focused ultrasound transmitters move and work in their area, accommodate magnetic resonance signals, receive I-emitting dual-use RF coils, are placed in their area, accommodate patients and their positioning, and the carrying system is in its area. Exercise, work, and ECG gating probes, respiratory gating probes, invasive thermocouples, etc. work in their area. All of these components and devices are fabricated and assembled from non-metallic and non-magnetic materials that meet the requirements, without interfering with, causing damage to, or causing artifacts in the magnetic field.

The test bed carrying the patient is placed in the positive direction of the y-axis from the outside of the magnet. The radio frequency is emitted from the outside of the body. The patient receiving the dual-use line, the patient in the supine position or the prone position is sent to the uniform magnetic field sample area in the magnetic gap space. After completion, the magnetic resonance imaging scan and the upper focused ultrasound transmitter are used to perform the treatment, and the patient is removed from the magnet area after the treatment is completed; the upper focused ultrasound transmitter adopts a multi-array spherical phase-controlled array structure design, and the multi-degree-of-freedom motion mechanism adopts Motor driven rail hanger mechanism. The rail mechanism is fixedly mounted along the y-axis direction in a position where there is sufficient space above the magnet in the scanning room, which is the basis of the entire hanger mechanism. The remaining motion mechanisms of the pylon mechanism are fixedly mounted below the slides that move along the track. The entire upper focused ultrasonic transmitter can perform movement in the X-axis, y-axis, and z-axis directions and rotate in the z-axis direction and swing in the X-axis direction. The front side of the transmitting surface of the ultrasonic transmitter is filled with a full Decontaminating the closed water of the purified water to facilitate coupling with the relevant part of the patient's body surface below it, conducting the focused beam into the patient's body; carrying the patient's examination bed B to set the outside of the body from the outside of the magnet in the positive direction of the y-axis The radio frequency transmitter I receives the dual-purpose line 圏, the patient in the supine position or the prone position, and sends the sample to the uniform magnetic field in the magnetic gap space. After the positioning is completed, the magnetic resonance imaging scan and the lower focused ultrasound transmitter are used to perform the treatment. Carrying the patient out of the magnet area; the lower focused ultrasound transmitter and its associated motion mechanism, the focused beam conducting structure is designed to be mounted inside the inspection bed B with which the multi-element planar phased array structure is used The multi-degree-of-freedom motion mechanism and the transmitter, which carry the transmitter for position and attitude adjustment, are collectively housed in a closed water tank filled with degassed purified water. The entire lower focused ultrasound transmitter can perform movement along the X-axis, y-axis, and z-axis directions. The upper surface of the water tank is a flexible film structure, the upper surface is flush with the bed surface, and the flexible film is swelled after being filled with water to facilitate coupling with the relevant part of the patient's body surface above it, and the focused beam is guided into the patient; The position of the examination bed carrying the patient is provided with a manual control device with a separate image real-time display LCD display and equipment emergency stop switch, so that the clinical staff can observe the positional relationship between the upper and lower high-energy focused ultrasound transmitters and the patient in real time. And control and adjustment.

In use, the electromagnetic shielding scanning room is also provided with a patient treatment condition monitoring, an electrocardiographic gating device, a respiratory door device and a nursing system to facilitate interventional functions and surgical operations.

The electromagnetic shielding scanning room is arranged with a gradient power supply system electrical cabinet, the RF power supply system is electrically rejected, the focused ultrasonic transmitter drives the power supply system electrical rejection, the degassing purified water treatment as a conductive medium is rejected, the computer cabinet, the operation console. The operating console is provided with another set of manual controls that control the movement of the upper and lower two high-energy focused ultrasound transmitters, and the magnetic resonance operation control system, image processing and display system, treatment area temperature display system, inter- and inter-scan intercom Image monitoring systems, etc. are used together. The entire operation console is equipped with an emergency stop switch for emergency handling.

In the design of the whole system, the present invention solves the influence of material problems on magnetic resonance imaging scanning from the following three aspects, including: selection of materials and components used for manufacturing two high-energy focused ultrasonic transmitter systems; ultrasonic coupling material Maintaining cleanliness; Maintaining the cleanliness of degassed purified water (detailed below).

The material problem of the present invention mainly refers to the problem of uniformity damage to the uniform magnetic field sample region caused by the ferromagnetic component such as iron, cobalt, nickel, etc. in the material of the relevant component, and causing significant artifact interference to the scanned image. .

In contrast to conventional in vitro high energy focused ultrasound tumor treatment systems, the therapeutic system of the present invention operates in a magnetic scanning chamber that meets electromagnetic shielding requirements and operates in a strong magnetic field environment. Mainly in the design of the upper and lower two high-energy focused ultrasound transmitters and their motion support mechanisms, degassing purification hydrocouples and devices and water pipeline systems. These improvements include:

The upper and lower high-energy focused ultrasound transmitters and most of their motion support mechanisms, degassing purification hydrocouples and devices are used within the 5 gauss range of permanent magnets. The components and components used are made of non-conductive, non-metallic and non-magnetic materials that do not affect the uniformity of the magnetic field sample area and do not cause artifacts in the MRI scan image. Full compliance with the safety requirements of magnetic resonance imaging and image quality assurance requirements.

Compared with the existing superconducting magnet magnetic resonance imaging guided external high-energy focusing ultrasonic device, only one lower focusing ultrasonic transmitter can work, the upper and lower two high-energy focused ultrasonic transmitters of the present invention can work independently, The treatment characteristics of different diseases and the body posture and treatment position requirements of the patients at the time of treatment are selected by the medical staff to select a suitable focused ultrasound transmitter for treatment.

In a preferred embodiment, the upper and lower two high-energy focused ultrasonic transmitters of the present invention all adopt a multi-element phased array type focused ultrasonic transmitter, which is characterized in that it can adopt multi-array spherical phase-controlled array focusing ultrasonic transmission. Multi-array arc-faced phased array focused ultrasound transmitter and multi-array planar phased array focused ultrasound Various types of phased array focused ultrasound transmitters such as emitters.

Compared to common non-phased array type in vitro focused ultrasound transmitters, which require complex multi-degree-of-freedom attitude control, the number of axes of motion required by a phased array focused ultrasound transmitter during multi-position treatment of a patient Less, simple posture control, and greatly reduced treatment time. The number of components and components used in the manufacture of the motion mechanism is small, and the components are structurally simple, and all of them can be manufactured using non-metal and non-magnetic materials to meet the requirements for use in a magnet environment.

Since the upper and lower two high-energy focused ultrasonic transmitter systems use motor-driven, computer-controlled mechatronic mechanisms to achieve the movement, adjustment, registration, and positioning of their spatial positions, the motor drives of the various motion axes in the motion mechanism and others The metal mechanism, the electromechanical component that affects the performance of the magnet debride field and the scanning process is preferably located outside the 5 gauss line of the magnet. 5 The mechanism used within the gauss line range is preferably fabricated using engineering plastics or other high-strength non-metal and weak magnetic components to avoid the effects of material problems on the MRI scan, all mechanical movements that need to be achieved within the 5 Gauss line range. And the transmission components can also avoid non-metallic and weak magnetic components in order to avoid the impact of magnetic resonance imaging scans due to material problems.

The high-strength plastic and non-metal and weak magnetic materials required by the invention not only meet the mechanical requirements of strength and rigidity, but also meet the requirements of the scanning process of the magnetic resonance system, do not affect the uniform magnetic field sample region, and do not cause artifact interference on the scanned image. . Corrosion resistant, anti-aging. Easy to manufacture, assemble and maintain, with no noise, long-term stability and accuracy.

In actual use, in order to improve or improve the acoustic coupling effect of the closed water raft in front of the emitting surface of the upper focused ultrasonic transmitter and the flexible film on the upper surface of the closed water tank accommodating the lower focused ultrasonic transmitter, medical personnel generally need water and ultrasonic conduction. The gel and similar properties are applied between a closed flexible water raft (or flexible film) bulged after filling with water and the skin of the patient. When performing similar operations, care should be taken not to include metal particles containing ferromagnetic components in the acoustic coupling material, etc. Affects the uniform magnetic field sample area and produces artifacts.

In one embodiment, the degassing purified water delivery pipeline system of the present invention is characterized in that a multi-layer degassing water filtration purification device composed of a high-density filter element and a water source located outside the scanning chamber of the magnet are used in the pipeline system. The degassing water magnetization filter adsorption device rejected by the water treatment keeps the entire pipeline clean, and strictly prevents the metal particles containing iron, cobalt, nickel and other ferromagnetic components generated in the pipeline system from being manufactured and working. Corresponding degassing purification hydrocouples and devices for the upper and lower high energy focused ultrasound transmitters. These particles not only affect the uniformity of the magnetic field, but also cause artifacts to the scanned image, and it is also possible to puncture the degassing and purifying the hydrocouple and device, causing a degassing water leakage accident, and injuring patients who are undergoing high-energy focused ultrasound therapy. And damage the magnetic resonance system.

In a preferred embodiment, the upper and lower two high-energy focused ultrasonic transmitters use the same set of degassing purified water production and delivery pipeline systems to produce, filter and supply degassed purified water, which is determined by the control system according to the requirements of use, drainage and drainage. Stop the water supply. The piping system for supplying degassed purified water should meet the sealing requirements and the requirements of the magnetic resonance scanning process, without missing the liquid corrosive magnet system, without affecting the uniform magnetic field and the magnetic resonance scanning process. The degassing purified water delivery line communicates with the upper and lower high-energy focused ultrasonic transmitters in the degassing purified water treatment cabinet and the magnet scanning chamber outside the scanning chamber of the magnet, and passes through the magnet scanning inter-conductive panel to enter the magnet scanning room. The tube in the scanning chamber of the magnet is divided into two parts, and a part of the tube is attached to the hanger mechanism of the upper high-energy focused ultrasonic transmitter and moves together with the hanger mechanism. The mechanical movement of the hanger mechanism does not affect the normal operation of the degassing purified water piping system. The other part of the line is attached to the test bed B containing the lower high-energy focused ultrasound transmitter and moves with the test bed B. Checking the mechanical movement of bed B should not affect the normal operation of the degassing and purifying water piping system.

The waterway system keeps the entire pipeline clean and prevents metal particles containing ferromagnetic components such as iron, cobalt, nickel, etc. produced during the manufacturing and operation of the piping system. Enter the water-filled closed flexible water tank (or water tank). These particles not only affect the uniformity of the magnetic field, but also cause artifacts to the scanned image, and may also break the closed flexible water raft (or flexible film), causing a degassing and purifying water leakage accident, and injuring high-energy focused ultrasound. Treated patients and damage the magnetic resonance system.

In summary, the present invention emphasizes the cleanliness requirements of the waterway system and related technical implementation measures. In an exemplary embodiment, a multi-layer degassing purified water filtration purification unit constructed of a high density filter element has been successfully used. In addition, the water source outside the magnet scanning chamber and the degassing purified water magnetization filter adsorption device in the water treatment rejection have also proven to be effective water treatment measures. These two points form the basis for the stable and safe use of degassed purified water in this design.

According to the present invention, the upper or lower focused ultrasound transmitter can be used alone, and the patient can be subjected to supine or prone position treatment and treatment process monitoring and efficacy examination under precise image guidance. Thereby expanding the indications for the treatment of high-energy focused ultrasound in vitro. When the focused ultrasound transmitter is not used, the magnetic resonance system can also perform independent imaging scans.

The inspection bed A for use with the upper focused ultrasound transmitter is characterized in that it is only a stretcher bed of fixed height, simple structure and low cost. It mainly carries the patient with the RF transmitting/receiving coil on the outside of the body into the uniform sample area of the magnet and is fixed in the working position.

In addition, as a highly mobile patient-bearing system, the bed can carry patients for different imaging subjects, different treatments, and transfer in hospital environments, such as X-ray image examination, gamma camera imaging , radiation therapy, chemotherapy, microwave hyperthermia, radiofrequency hyperthermia, surgery, etc.

The bed is based on the scanning of the magnets in accordance with the electromagnetic shielding requirements of the present invention, and the equipment and the enlarged area are increased to improve the comprehensive diagnosis and treatment methods including real-time magnetic resonance imaging, high-intensity focused ultrasound therapy, and surgery. The treatment room is very helpful and is an important vehicle for the system. A test bed B for use with a lower focused ultrasound transmitter is characterized in that it contains a lower high energy focused ultrasound transmitter and its motion support mechanism, a degassing purification hydrocouple and device, and the like. When the lower high-energy focused ultrasound transmitter is not required, the inspection bed B can be pushed out of the magnet working area, replaced with a test bed, with the upper high-energy focused ultrasound transmitter or with independent magnetic resonance imaging of the patient.

When the upper high-energy focused ultrasound transmitter is in operation, it can be used in conjunction with the inspection bed, or it can be used in conjunction with the inspection bed B after the lower high-energy focused ultrasound transmitter has stopped working. When the lower high energy focused ultrasound transmitter is in operation, the upper high energy focused ultrasound transmitter typically moves out of the magnet area as a whole. To enhance the openness of the treatment system and reduce the claustrophobia of the patient.

The power distribution and control unit cables of these motion mechanisms are routed through the conductive plates to the magnet scanning room, which is connected to the power supply and control system outside the scanning room.

As a high-openness permanent magnetic resonance imaging system for an image guiding system, the present invention comprises two sets of inspection beds for use with upper and lower two high-energy focused ultrasonic transmitters respectively (inspection bed with upper high-energy focused ultrasonic transmitter) And the inspection bed B) used with the lower high-energy focused ultrasound transmitter, which can be kept at a working height, and the part of the permanent magnet 5 gauss line is made of non-conductive, non-metallic and non-magnetic materials. The bed panel is made of high-strength, deformation-resistant glass fiber reinforced plastic (FRP) material, which not only meets the strength and rigidity requirements of the bed surface, but also does not constitute magnetic field uniformity because the FRP material does not contain ferromagnetic particles. Affects and produces artifact interference on the scanned image. The design of the bed panel can also take into account the seating and fixing of the signal receiving/emitting dual-purpose cable and the arrangement and fixing of the cable signal transmission cable, and design corresponding signal interfaces.

In order to meet the requirements of certain treatment positions of patients, it may also include a pad with a wedge shape, a square shape, and the like, a head rest, a neck support, an arm rest and the like to fit a large mattress under the patient to support the patient's long-term comfort. In the position of treatment.

The invention has wide application, according to general requirements, except that the body contains a metal bracket and a heart Magnetic resonance imaging scans can be performed outside of a dirty pacemaker or a patient who is not suitable for magnetic resonance imaging, and thus can benefit from the treatment methods and systems described herein for tumor treatment.

According to another aspect, a system and design of the present invention can provide a method of image guidance for in vitro high energy focused ultrasound therapy using a permanent magnetic resonance imaging system, which includes the following steps:

(1) using a permanent magnet to create a uniform magnetic field sample area in its center;

(2) by transmitting a scanning signal for receiving the I-emitting dual-purpose RF coil on the outside of the body of the examinee, moving the examination bed carrying the inspected person and the RF coil, so that a target layer of the tissue to be inspected is in the sample area. Center

(3) Using the radio frequency transmitting line to transmit the radio frequency field to activate the above-mentioned purpose level;

(4) generating a gradient field in the sample area and spatially encoding the nuclear spin at the target level;

(5) performing magnetic resonance imaging on the target level, and receiving the magnetic resonance signal of the target layer by using the radio frequency receiving line, and processing the magnetic resonance imaging system to obtain an image reflecting the tissue state of the lesion;

(6) adjusting the layer thickness by the magnetic resonance imaging system;

(7) Repeat steps (3) through (6) to perform multi-layer imaging to obtain a layered image reflecting the condition of all tissues at the examination site;

(8) Controlling the movement of the emitter of the in vitro high-energy focused ultrasound therapy device, and by observing the magnetic resonance image reflecting the real-time change of the position of the emitter, the focused focal region is positioned within the target site to be treated in the selected layer.

In use, the method further includes the following steps:

(9) Start the focused ultrasound emission, observe the magnetic resonance image reflecting the change of the tissue condition in the selected layer in real time, and extract the temperature distribution information about the focal area. DRAWINGS The present invention will be described in detail below with reference to the accompanying drawings and a specific embodiment, wherein

1 is a schematic structural view of an embodiment of an in vitro high-energy focused ultrasound acoustic tumor treatment system for performing image guidance and therapeutic effect monitoring and examination using a permanent magnetic resonance imaging system with a high openness horizontal field arrangement according to the present invention;

2 is a schematic structural view of a ϋ-type permanent magnet in a high-openness horizontal field arrangement according to an embodiment of the present invention;

3 is a block diagram showing the system configuration of the entire system according to an embodiment of the present invention; FIG. 4 is a flow chart of performing tumor treatment according to an embodiment of the present invention; FIG. 5 is a magnetic resonance imaging level according to an embodiment of the present invention. Focusing the focal region of an in vitro focused ultrasound transmitter;

6 is a schematic structural view of an upper external high energy focused ultrasound transmitter and a hanger mechanism motion system thereof according to an embodiment of the present invention;

Figure 7 is a diagram showing other structural aspects of an upper extracorporeal high energy focused ultrasound transmitter and its motion system in accordance with one embodiment of the present invention;

8(a) and (b) are schematic diagrams showing the operation of an upper external high energy focused ultrasound transmitter according to an embodiment of the present invention;

9(a) and (b) are schematic structural views of a lower in vitro high energy focused ultrasound transmitter and a motion system thereof according to an embodiment of the present invention;

Figure 10 is a schematic illustration of the operation of a lower in vitro high energy focused ultrasound transmitter in accordance with one embodiment of the present invention;

Figure 11 is a schematic diagram showing the working principle of two high-energy focused ultrasonic transmitters using the same set of degassing water production and delivery piping systems to produce, filter and supply degassed water;

FIG. 12 is a schematic diagram of an integrated system for interventional diagnosis, treatment, and surgery, with the entire system and the electromagnetic shielding scanning as a main body according to an embodiment of the present invention. detailed description Referring to Figure 1, the figure generally shows the structural composition of the entire permanent magnetic resonance imaging guided in vitro high energy focused ultrasound tumor treatment system. 1 is a permanent magnet system, 2 is an upper external high-energy focused ultrasound transmitter and its orbital hanger mechanism, 3 is an inspection bed, 4 is an inspection bed containing a lower external high-energy focused ultrasound transmitter, and 5 is a transmitter. Position manual control device, 6 is the RF transmitting/receiving line for the upper external high-energy focused ultrasound transmitter, 7 is the RF transmitting/receiving line for the lower external high-energy focused ultrasound transmitter, and 8 is the patient's treatment status. Surveillance system, 9 for ECG gated and respiratory gating device, 10 for bed care system, 11 for electromagnetic shielding scanning, 12 for electromagnetic shielding scanning, and 13 for gradient power system electrical rejection, 14 Electrical rejection for RF power system, 15 for focused ultrasound transmitter drive power system electrical cabinet, 16 for degassing purified water treatment rejection, 17 for operation console, 18 for computer cabinet.

Referring to Figure 2, the structural composition of a 永磁-type permanent magnet in a high openness horizontal field arrangement is illustrated in accordance with a preferred embodiment. The magnet system is primarily designed for use with an in vitro high-energy focused ultrasound tumor treatment system with two upper and lower emitters. The magnets are U-shaped. Wherein 1-1 is the right yoke iron, 1-2 is the left yoke iron, 1-3 is the bottom yoke iron, 1-4 is the right magnetic yoke (dip pole), and 1-5 is the left magnetic yoke (S Pole), 1-6 is the right pole piece, 1-7 is the left pole piece, 1-8 is the 笫 gradient coil, 1-9 is the second gradient 圏, 1-10 is made of glass fiber reinforced plastic ( The outer shell of the magnet made of FRP material, 1-11 is a magnet temperature control system including an insulating layer. Since most of the structures of the U-shaped permanent magnet itself and the turns are prior art, the items 1-1 to 1-9 will not be described in detail.

The magnet housings 1-10 are manufactured in a block-and-block fashion, and then integrally assembled and spliced together to tightly encase the magnet system, separating all of its mechanical and electrical components from the patient.

According to a preferred embodiment, a magnet outer casing made of a glass fiber reinforced plastic (glass reinforced plastic) material is manufactured by a block design, a block manufacturing method, and then The overall fit, splicing and assembly together tightly encases the magnet system, separating all of its mechanical and electrical components from the patient.

The bottom housing in the magnet housing 1-10 is designed with a special water collection system to prevent the degassing purified water as a coupling from leaking into the magnet and causing electrical safety.

According to a preferred embodiment, the magnet temperature control system 1-11 contains a specially designed insulating layer of flame-retardant sponge material characterized in that it consists of a plurality of blocks of flame-retardant sponge material of various shapes and sizes. These blocks of material are integrally assembled, lapped, laminated, spliced and assembled together, tightly enclosing the yoke and a feedback temperature control system composed of a plurality of temperature measuring devices and electric heating devices arranged thereon, which constitute a strict The magnet insulation layer can realize large-area insulation and ensure uniformity and stability of magnet temperature control.

As shown in Fig. 2, preferably, the magnetic gap between the magnetic poles may have a pitch of 600 mm. This achieves the need to safely accommodate patients for magnetic resonance imaging and focused ultrasound emission therapy with good ergonomics. It not only helps patients overcome claustrophobia, but also helps medical staff to observe the patient's condition in real time and monitor the treatment process.

Referring to the block diagram shown in Figure 3, the architecture of the overall system is depicted in accordance with one embodiment, and the relationships between the major subsystems can be understood. These subsystems include: Permanent magnet magnet subsystems;

Upper focused ultrasound transmitter subsystem;

a lower focused ultrasound transmitter subsystem;

a patient-bearing positioning subsystem for use with an upper focused ultrasound transmitter; a patient-bearing positioning subsystem for use with a lower focused ultrasound transmitter; and a computer and image processing subsystem,

The permanent magnet magnet subsystem adopts a U-shaped arrangement magnet, and the structural characteristics of the U-shaped permanent magnet are: creating a large-sized ellipsoidal uniform magnetic field sample region in its own center, one channel before and after Through, open upper and lower magnetic gap spaces, a large available magnetic gap spacing and maximum available field strength. In addition, the upper/lower focused ultrasound transmitter multi-degree of freedom attitude control subsystem, the high energy focused ultrasound conducting structure and the conductive medium processing subsystem, the inter-scanning and the conductive plate subsystem may be included in actual use.

The computer and image processing subsystem controls the operation and data acquisition of the entire system, for example, may include a gradient controller that controls the gradient line, controls the sequence of RF signal transmission and reception, the amplifier, the host computer operates the controller, The built-in operation controller controls the upper/lower focused ultrasonic transmitter multi-degree of freedom attitude control subsystem, the high energy focused ultrasonic conduction structure and the conductive medium processing subsystem, the upper I lower focus ultrasonic transmitter power supply system, etc., through data detection filtering, Data processing, image processing, image display, etc. for data processing and image display. One skilled in the art can easily design the control system, and Figure 3 clearly shows one of the specific configurations. In view of the fact that the present invention can employ computer and image processing subsystems of the prior art, it is not necessary to describe them in detail herein.

Referring to the flow chart shown in Fig. 4, the process of tumor treatment using the present invention can be understood.

This embodiment illustrates a method for image guidance and treatment process monitoring and efficacy examination of a high-energy focused ultrasound tumor treatment using a high-openness permanent magnetic resonance imaging system, which includes the following steps:

(1) Using a permanent magnet to create a larger ellipsoidal uniform magnetic field sample area in its center. The constituent features of the magnet are: a horizontal field U-shaped high open magnet structure with a large magnetic gap spacing and a left and right magnetic pole arrangement. The yoke is composed of a left yoke, a right yoke, and a bottom yoke. The iron and the right yoke are arranged symmetrically, and the bottom yoke is the basis of the entire magnet. The magnetic yoke on the right side (N pole) is located on the left side of the right yoke, and the magnetic yoke on the left side (S pole) is located on the right side of the left yoke. The two magnetic yokes are parallel and opposite. The magnetic flux is emitted by the magnetic field on the right side, passes over the magnetic gap space between the two turns, penetrates the magnetic yoke on the left side, and returns to the magnetic yoke on the right side by the bottom yoke, forming a closed loop;

(2) by transmitting a signal for receiving a scan on the outside of the patient's body. An RF coil, moving the test bed carrying the patient and the RF coil, so that a target level of the tissue of the examined lesion is at the center of the sample area;

(4) spatially encoding the nuclear spin at the target level by generating a gradient field in the sample region by two gradient lines disposed on the right side of the magnet and the left side of the magnetic head facing the patient;

(5) Perform magnetic resonance imaging on the target level. The magnetic resonance signal of the target layer is connected by the radio frequency receiving line, and processed by the magnetic resonance imaging system, and an image reflecting the tissue condition of the lesion site is quickly obtained;

(6) adjusting the layer thickness by the magnetic resonance imaging system, and selecting another target level;

(7) Repeat steps (3) to (6) to perform multi-layer imaging to obtain a layered image reflecting the condition of all lesions in the lesion; and then determine the surgical plan accordingly;

(8) According to the surgical plan, select the treatment level;

(9) After determining the treatment level, manually control the movement of the emitter of the in vitro high-energy focused ultrasound tumor treatment device, and closely observe the magnetic resonance image reflecting the real-time change of the position of the emitter, so that the focused focal region is positioned in the selected level and needs treatment. Within the target site of the lesion;

(10) Start the focused ultrasound emission therapy, observe the magnetic resonance image reflecting the change of the lesion tissue in the selected layer in real time, and extract the temperature distribution information about the focal region. Determining the therapeutic effect of the selected focal focus and determining to extend the treatment time or complete the treatment;

(11) After completing the focused treatment of the target site of the selected lesion, according to the size of the lesion site in the selected treatment layer, manually controlling the movement of the transmitter of the focused ultrasound tumor treatment device in vitro, so that the focused focal region is in the selected lesion. Move and reposition within the untreated area. Repeat step (10), after repeated movement and positioning, repeatedly operate the focused ultrasound emission therapy to complete the treatment and treatment effect examination of the target site of the lesion in the selected layer; (12) choose a new treatment level;

(13) Repeat steps (9) through (12) until the treatment and treatment effects of all target sites in all treatment layers are completed.

Referring to Figure 5, the relationship between the magnetic resonance imaging plane and the focal focus of the in vitro focused ultrasound transmitter can be seen.

According to the Cartesian coordinate system, the coordinate system of the composite system is set as follows: The X-axis and z-axis planes of the system correspond to the patient's cross section (Axial Plane), the system's y-axis and z-axis plane correspond to the patient sagittal plane ( Sagittal Plane ) , the system's x-axis and y-axis plane correspond to the patient's Coronal Plane.

Referring to Figure 6, the composition of the upper external high-energy focused ultrasound transmitter and its hanger mechanism can be understood.

According to one embodiment, the upper high-energy focused ultrasound transmitter 2-1 employs a motor-driven orbital hanger mechanism 2-2 to effect movement, adjustment, registration, and positioning of its spatial position, and the hanger mechanism 2-2 can implement the upper portion. High-energy focused ultrasound transmitter left and right (system X-axis), front and rear (system y-axis) and up-and-down lifting motion (system z-axis), high-energy focused ultrasound transmitter swing (around system X-axis swing) and high-energy focusing The rotation of the ultrasonic transmitter (rotating around the Z-axis of the system) requires movement of the five axes of motion.

In an exemplary example, the movement in the y-axis direction is achieved by a set of motor drives, a rubber timing belt, a slide wheel that is pulled by the synchronous wheel, and a slide mechanism that is fixed to the level of the aluminum profile above the inner magnet of the sweeping room. The lower part of the beam; the movement in the X-axis direction is realized by another motor drive, the rubber timing belt, the slide rail pulled by the synchronous wheel, and the slide mechanism; the X-axis slide rail is fixed below the y-axis slide plate, and the lower side of the X-axis slide plate is the z-axis lift The mechanism, the z-axis drive unit is located in the X-axis slide, and the motor-driven rubber timing belt lifting and lowering mechanism is set by gravity balance. The pitching motion of the upper high energy focused ultrasound transmitter is achieved by a combination of the z-axis rotation about the system and the X-axis swing about the system. The z-axis rotation system consists of a motor-driven gear pair mechanism, and the X-axis oscillating system is driven by a motor. Rubber timing belt and synchronous wheel transmission mechanism. The two sets of motion mechanisms are mounted on a single body and are located entirely below the Z-axis lifting mechanism. Each motion axis is equipped with a pulse encoder to accurately measure the displacement and rotation angle, a travel switch to control its range of motion, and a mechanical stop to prevent motion overshoot. The motion control of the upper high-energy focused ultrasonic transmitter 2-1 and its hanger mechanism 2-2 employs a step-by-step control method in which the respective motion axes are independent of each other. Two sets of real-time display with image and equipment emergency stop switch manual control device, one set in the magnet scanning room, near the magnet to the position of the test bed carrying the patient; another set of manual control device is set outside the magnet scanning room On the operation console, it is used together with the magnetic resonance operation control system, image processing and display system, treatment area temperature display system, inter-scan intercom and image monitoring system. The entire operation console is equipped with an emergency stop switch for emergency handling.

Since the entire motion mechanism and motion control are prior art, they are not described in detail except for their materials.

In the present invention, the mechanism used in the range of the 5 gauss line and its constituent parts and components are manufactured using the required engineering plastics, non-metal and weak magnetic materials to avoid the influence of the material problem on the magnetic resonance imaging scan. Therefore, the hanger mechanism 2-2 is actually different from the similar orbital type used in medical diagnostic equipment such as a conventional X-ray machine, a surgical shadowless lamp, a monitor, a ventilator, an anesthesia machine, and the like. Rotary slip hanger mechanism.

In summary, the present invention has repeatedly emphasized in the application of materials that the motion mechanism of the upper high-energy focused ultrasonic transmitter 2-1 located within the range of the 5 gauss line is manufactured and assembled by specially designed non-metallic and weakly magnetic materials. feature. Referring to Fig. 7, it can be understood that the joint surgical robot holds the upper external high-energy focused ultrasound transmitter 2-1 to realize the operation principle of multi-degree of freedom attitude control. As shown in Figure 7, this technical feature is not only applicable to the orbital electric hanger mechanism described in this design, but also to robots (articulated surgical robots, multi-coordinate slides, turntables, etc.), rotating Sliding hangers and the like can hold the upper high-energy focused ultrasound transmitter 2-1 to complete other mechanical structures for therapeutic registration and positioning requirements. As long as they meet the requirements of the 5 gauss line, the non-metallic and weak magnetic materials realized by the present invention are manufactured and assembled, and the imaging guided treatment process of the high-energy focused ultrasound system can be completed in conjunction with the magnetic resonance system. Therefore, the present invention actually accommodates and covers other motion mechanisms that can clamp the movement of the upper high-energy focused squeaky emitter and cooperate with the U-shaped permanent magnet to complete the high-energy focused ultrasound treatment process. In general, the present invention includes: Frame mechanism, rail type manual hanger mechanism, manipulator (joint type surgical robot, multi-coordinate slide table and turntable, etc.), rotary slide type hanger, etc.

Referring to Figures 8(a) and (b), the operation of the upper external high energy focused ultrasound transmitter in accordance with an embodiment of the present invention will be appreciated. The upper external high-energy focused ultrasound transmitter is coupled with the patient's skin by a water-filled closed flexible water 2-3, which can be made of polyester film, polyvinyl chloride (PVC), silicone rubber, etc. The shape is easily changed with the porch of the patient's body lying on the examination bed 3, which is a mature coupling technique and will not be described again. It has the following advantages: On the one hand, the closed flexible water raft filled with deaerated water can completely cover the high-energy focused ultrasound focused beam area and meet the beam transmission requirements. On the other hand, the water-filled closed flexible leeches can protect patients from high energy. The motion of the focused ultrasound transmitter may cause crushing and injury to the patient's body after losing control.

Referring to FIG. 1, the range of motion and the working area of the upper high-energy focused ultrasonic transmitter 2-1 are included in the gap left after the signal receiving/emitting dual-purpose line 圏6 for magnetic resonance scanning is installed in the outer side of the patient's body. The position adjustment process of the upper high-energy focused ultrasound transmitter 2-1 should not collide and affect the position of the signal receiving I transmitting dual-purpose line 圏6 to avoid affecting the image quality of the magnetic resonance scanning.

Referring to FIG. 1, when the upper high-energy focused ultrasonic transmitter 2-1 is operated independently, the patient of the scanning bed A 3 carrying the magnetic resonance scanning signal receiving/emitting dual-purpose line 圏6 on the outside of the body enters the magnet 1 and is suitable The position is in place and fixed. The inspection When the bed 3 is in place, a laser positioning light can be used to determine its exact position. Since the motion of the inspection bed 3 in the y-axis direction is relatively simple and simple, no movement is required in the X-axis and z-axis directions, and the laser positioning lamp can be accurately positioned in the y-axis direction, so the working height is designed as a simple support structure. Fixed manual operating bed.

Referring to Figures 9(a) and (b), a system configuration of the lower in vitro high energy focused ultrasound transmitter 4-8 in accordance with an embodiment of the present invention will be appreciated. The lower high-energy focused ultrasound transmitter 4-8 is designed to be placed under the FRP bed panel carrying the patient's examination bed B4. The entire emitter is contained in a closed water tank filled with degassed purified water, and the upper surface of the tank is flush with the bed panel.

In an exemplary example, the closed water tank is designed as a hexahedral structure, including the lower surface panel 4-1, the upper surface of the fixed circular frame 4-2 and the flexible flexible membrane 4-3 in the frame, four The side faces 4-4, 4-5, 4-6, 4-7 are also composed of a flexible film which is sealingly joined to the upper and lower surface plates. The upper surface plate is fixed to the bed panel carrying the patient's examination bed B4, flush with the bed panel. The panel below supports the multi-element planar phased array focused ultrasound transmitter 4-8 immersed in the degassed purified water above it, enabling left and right (X-axis of the system), front and rear (y-axis of the system) and up and down position Adjust the motion requirements of the three motion axes of the motion (the z-axis of the system). The four side flexible films 4-4, 4-5, 4-6, 4-7 move in accordance with the movement of the lower surface fixing plate 4-1, and the sealed state of the closed water tank is always maintained. The upper surface sheet flexible membrane bulges after filling with water and is tightly coupled to the body surface that the patient needs to treat.

The lower panel 4-1 of the closed water tank uses motor-driven rubber timing belt, synchronous wheel traction slide and slider mechanism to realize the movement, adjustment, registration and positioning of its spatial position. The entire movement mechanism is located in the inspection bed. B is supported inside the framework. Each motion axis is equipped with a pulse encoder to accurately measure the displacement and rotation angle, a travel switch to control its range of motion, and a mechanical stop to prevent motion overshoot. The motion control of the lower high-energy focused ultrasound transmitter motion mechanism uses a separate step-by-step control method between the motion axes. Using two sets of manual controls, one set with upper high energy focus The ultrasonic transmitter is combined with a manual control system disposed outside the magnets within the scanning chamber of the magnet. Another set is combined with a manual control system with an upper high-energy focused ultrasound transmitter placed on the outer scanning console of the magnet.

Since the entire motion mechanism and motion control are prior art, they are not described in detail except for their materials. In the present invention, the components and components of the mechanism used in the 5 gauss line range are made of non-metallic and weak magnetic materials which meet the requirements to avoid the influence of the material problem on the magnetic resonance system.

Referring to Fig. 10, the operation of the lower in vitro high energy focused ultrasound transmitter 4-9 in the treatment according to an embodiment of the present invention can be clearly understood.

The closed water tank accommodating the lower high-energy focused ultrasonic transmitter 4-9 is coupled with the patient's skin by a flexible soft film 4-3 which is swelled by water filling the upper surface of the water tank, and the flexible flexible film can be coated with polyester film, poly Made of vinyl chloride (PVC), silicone rubber, etc., the shape of the bulging portion is easily changed with the contour of the patient's body lying on the examination bed. This is a mature coupling technique and will not be described again. The high-energy focused ultrasound focused beam area is fully contained in a closed environment filled with degassed water, fully covering and meeting the transmission requirements of high-energy focused ultrasound focused beams.

In actual use, in order to improve or improve the acoustic coupling effect, medical personnel generally use water, ultrasonic conductive gel and similar properties of materials 4-10 to coat the closed flexible leeches bulged after filling with water and the skin of the patient. between. When performing similar operations, care should be taken not to include metal particles containing ferromagnetic components in the acoustic coupling material, so as not to affect the uniformity of the magnetic field and cause artifacts.

The range of motion and working area of the lower high-energy focused ultrasound transmitter 4-9 is included in the gap left by the signal receiving/emitting dual-purpose coil 1 for magnetic resonance scanning after being placed in place under the patient's body, the lower high-energy focused ultrasound transmitter The 4-9 position adjustment process should not collide and affect the signal reception I to transmit the position setting of the dual-purpose coil 7 so as not to affect the image quality of the magnetic resonance scan.

Referring to Figure 1, when the lower high-energy focused ultrasound transmitter 4-9 is required, it is independent. When doing this, first connect the relevant circuit and waterway, and then let it move along the y-axis along with the patient's bed on the examination bed and the signal receiving/emitting dual-use line 圏7 of the patient's scanning site. , enter the magnet 1 and position it in place and secure it. When the bed is in place, a laser positioning light can be used to determine its exact position. Since the movement of the inspection bed in the y-axis direction is relatively simple and simple, no movement is required in the X-axis direction, and the laser positioning lamp can be accurately positioned in the y-axis direction.

Referring to FIG. 11, according to an embodiment of the present invention, two upper and lower high-energy focused ultrasonic transmitters use the same set of degassing purified water production and delivery pipeline system to produce, filter and supply degassed purified water, which are controlled according to usage requirements. The system decides to water, drain and stop the water supply. The piping system for supplying degassed purified water should meet the sealing requirements and the requirements of the magnetic resonance scanning process, and the liquid rusting magnet system should not be missed, and the magnetic field hooking zone and the magnetic resonance scanning process are not affected. The degassing purified water delivery line communicates with the upper and lower two high-energy focused ultrasonic transmitters in the degassing purified water treatment and magnet scanning room outside the magnetic scanning chamber, and passes through the magnet scanning inter-conductive panel to enter the magnet scanning room. The pipeline in the scanning chamber of the magnet is divided into two parts, and a part of the pipeline is attached to the hanger mechanism of the upper high-energy focusing ultrasonic transmitter and moves together with the hanger mechanism. The mechanical movement of the pylon mechanism should not affect the normal operation of the deaerated water piping system. The other part of the line is attached to the test bed B that houses the lower high-energy focused ultrasound transmitter and moves with the inspection bed B. Checking the mechanical movement of bed B should not affect the normal operation of the deaerated water piping system.

The waterway system keeps the entire pipeline clean and strictly prevents the metal microparticles containing ferromagnetic components such as iron, cobalt, nickel, etc. produced during the manufacturing and working process from entering the water-filled closed flexible water raft. These particles not only affect the uniformity of the magnetic field, but also cause artifacts to the scanned image, and may also break the closed flexible water raft (or flexible film), causing a degassing water leakage accident, and injuring high-energy focused ultrasound therapy. The patient has damaged the magnetic resonance system.

In summary, the present invention emphasizes the cleanliness requirements of waterway systems and related technologies. Implementing measures. In an exemplary embodiment, a multi-layer degassing purified water filtration purification device constructed of a high density filter element has been successfully applied. In addition, the water source outside the scanning chamber of the magnet and the degassing purified water magnetization filter adsorption device in the water treatment rejection have also proved to be effective water treatment measures. These two points form the basis for the stable and safe use of degassed purified water in this design.

Referring to FIG. 12, the figure shows the addition of equipment and the enlarged area based on the scanning of the magnets according to the electromagnetic shielding requirements of the present invention, and is improved to include real-time magnetic resonance imaging, in vitro high-energy focused ultrasound therapy, and surgery. The situation of a comprehensive medical treatment room where a variety of medical treatments are integrated.

In addition to the composition of the entire permanent magnetic resonance imaging guided extracorporeal high-energy focused ultrasound tumor treatment system shown in FIG. 1, the enlarged and improved integrated comprehensive treatment room shown in FIG. 12 further includes a surgical instrument table 21 and an infusion stand 22 , an anesthesia machine 23, a ventilator 24, a monitor 25, and the like. The condition is that they do not affect the uniformity of the magnetic field and cause artifacts to the magnetic resonance scanned image.

While the present invention has been described with respect to the preferred embodiments of the present invention, those skilled in the art can understand that the specific technical solutions disclosed in the specification can be carried out without departing from the spirit and scope of the invention. Various changes and modifications.

Claims

Rights request

A method for image guidance of in vitro high-energy focused ultrasound therapy using a permanent magnetic resonance imaging system, comprising the steps of:

(2) moving the test bed carrying the inspected person and the radio frequency coil by placing a scanning signal for receiving the I-emitting dual-purpose RF coil on the outside of the body of the examinee, so that a target layer of the tissue to be inspected is in the sample area. center of;

(4) generating a gradient field in the sample area, spatially encoding the nuclear spin at the target level;

(6) adjusting the layer thickness by the magnetic resonance imaging system;

(8) Controlling the movement of the emitter of the in vitro high-energy focused ultrasound therapy device, and by observing the magnetic resonance image reflecting the real-time change of the position of the playing piece, the focused focal region is positioned within the target site to be treated in the selected layer.

2. The method of claim 1 further comprising the steps of:

(9) Start the focused ultrasound emission, observe the magnetic resonance image reflecting the change of the tissue status in the selected layer in real time, and extract the temperature distribution information about the focal area.

3. The method according to claim 1, wherein the structural feature of the magnet is: a horizontal field U-shaped high open magnet structure having a large magnetic gap spacing and a left and right magnetic pole arrangement, the yoke iron is composed of a left yoke, a right yoke, The bottom yoke is composed of three parts, the left yoke and the right yoke are symmetrically arranged, and the bottom yoke is the base δ3⁄4 of the entire magnet; The pole is located on the left side of the right yoke, the left side of the magnetic yoke (S pole) is located on the right side of the left yoke, and the two magnetic yokes are parallel to each other; the magnetic flux is emitted by the right side of the yoke, crossing between the two cymbals The magnetic gap space penetrates the magnetic yoke on the left side, and then the bottom yoke returns to the magnetic yoke on the right side to form a closed loop.

The method according to claim 3, wherein the gradient field is generated in the sample region by two gradient lines disposed on the right side of the magnet and the left side of the magnetic field facing the examinee side.

5. A horizontal field permanent magnetic resonance imaging system for use with an in vitro high energy focused ultrasound therapy system, comprising:

a permanent magnet system for creating a uniform magnetic field sample zone; a gradient subsystem for generating a gradient field in the sample zone;

An RF subsystem for transmitting a radio frequency field to activate a target level of the object to be inspected; an upper focused ultrasound transmitter subsystem including an upper high energy focused ultrasound transmitter;

a lower focused ultrasound transmitter subsystem comprising a lower high energy focused ultrasound transmitter;

The object to be inspected for use with the upper focused ultrasound transmitter carries the positioning subsystem; the object to be inspected with the lower focused ultrasound transmitter carries the positioning subsystem;

Computer and image processing subsystem,

The permanent magnet magnet subsystem adopts a U-shaped arrangement magnet, and the structure characteristic of the 永磁-type permanent magnet is: a large-sized ellipsoidal uniform magnetic field sample area is formed in its own center, and a channel type front and rear Through, open upper and lower magnetic gap spaces, a large available magnetic gap spacing and maximum available field strength.

6. The system according to claim 5, wherein the structure of the ϋ-type permanent magnet of the permanent magnet magnet subsystem is: a ϋ-type high open magnet structure arranged on the left and right sides of the magnetic pole, the yoke is made of the left side yttrium, the right side Yoke, bottom yoke, three parts, left The yoke iron and the right yoke iron are symmetrically arranged and fixed on the bottom yoke, and the bottom yoke is the foundation of the entire magnet; the right magnetic yoke (N pole) is located on the left side of the right yoke, and the left side yoke (S pole) ) is located on the right side of the left yoke, the two magnetic turns are parallel; the magnetic flux is emitted by the right magnetic ridge, crossing the magnetic gap space between the two turns, penetrating into the left magnetic yoke, and then returning to the right by the bottom yoke Magnetic enthalpy, forming a closed loop;

The gradient subsystem includes first and second gradient lines 布置 disposed on a side of the magnet on the right side of the magnet and a side on the left side of the magnet facing the object to be inspected, and the two gradient lines are parallel to each other.

7. The system according to claim 6, wherein the stability of the overall temperature of the magnet is stabilized by a feedback temperature control system comprising a plurality of temperature measuring devices and electric heating devices mounted on the yoke and a yoke wrapped to prevent heat loss. Layer to achieve.

8. The system according to claim 6, wherein the magnetic gap between the magnetic poles is 600 mm apart.

9. The system according to claim 5 or 6, wherein the ellipsoidal uniform magnetic field sample region, the three radii of the ellipsoid are 400 mm, 400 mm, and 380 mm, respectively; and the upper and lower two high-energy focused ultrasonic transmitters can be accommodated to move in the region thereof. , work, accommodate magnetic resonance signal receiving, I transmit dual-purpose RF cable, set in its area, accommodate the object to be inspected and the object to be inspected, the positioning and positioning subsystem moves and works in its area, and the probe for ECG gating, breathing Devices such as gated probes and invasive temperature probes operate in their area; all of these components and devices are manufactured and assembled from non-metallic and non-magnetic materials.

10. A system according to claim 5 or 6, wherein the upper and lower two high energy focused ultrasound transmitters are each independently operable.

11. The system according to claim 10, wherein at least one of the upper and lower two high energy focused ultrasound transmitters employs a multi-element phased array type focused ultrasound transmitter, and the multi-element phased array type focused ultrasound transmitter is selected from the group consisting of Multi-array spherical phased array focused ultrasound transmitter, multi-array arc-faced phased array focused ultrasound transmitter or multiple arrays A meta-plane phased array focused ultrasound transmitter.

12. The system according to claim 6, wherein the outer shell of the magnet is made of a glass fiber reinforced plastic (glass reinforced plastic) material, which is manufactured by a block design and a block manufacturing method, and then integrally assembled and spliced and assembled. The magnet system is tightly wrapped to separate all of its mechanical and electrical components from the object being inspected. The bottom casing is designed with a special water collection system to prevent the degassing purified water as a coupling from leaking into the magnet and causing electrical safety accidents.

13. The system according to any one of claims 5, 6, and 11, wherein the object to be inspected for use with the upper focused ultrasound transmitter is an inspection bed, and the lower focus ultrasound transmitter is inspected The object bearing positioning subsystem is the inspection bed B. Their parts in the range of the permanent magnet 5 gauss line are made of non-conductive, non-metallic and non-magnetic materials, and the bed panel is made of high-strength, deformation-resistant glass fiber reinforced plastic (glass reinforced plastic). ) Made of materials.

14. A system according to claim 5 or 6, wherein the upper and lower two high energy focused ultrasound transmitters and most of their motion support mechanisms, degassing purification hydrocouples and devices are used within the 5 gauss line of the permanent magnet. The parts and components used are made of non-conductive, non-metallic and non-magnetic materials.

15. The system according to claim 5 or 6, further comprising a degassing purified water delivery pipeline system, wherein the pipeline system uses a multi-layer degassing water filtration purification device composed of a high density filter element and a water source located outside the scanning chamber of the magnet and The degassed water magnetization filter adsorption device in the water treatment rejection keeps the entire pipeline clean.

16. The system of claim 13, wherein the inspection bed B contains a lower high energy focused ultrasound transmitter and its motion support mechanism, a degassing purification hydrocouple and device, and the like. When the lower high-energy focused ultrasound transmitter is not required, the inspection bed B can be pushed out of the magnetic working area, replaced with an inspection bed with the upper high-energy focused ultrasound transmitter or with independent magnetic resonance imaging.

17. The system according to claim 13, wherein the check bed is a height Fixed-size stretcher bed. It mainly carries the object to be examined on the outside of the body with the RF emission I receiving line 进入 into the uniform sample area of the magnet and is fixed in the working position.

18. The system of claim 6 wherein said ϋ-type arrangement of permanent magnets is characterized in that said magnets are comprised of a single type of permanent magnet material. Different grades of sintered NdFeB and SmCo alloys can be used for permanent magnet materials.

19. The system of claim 7 wherein the insulating layer comprises a flame retardant sponge material characterized by a plurality of blocks of flame retardant sponge material of various shapes and sizes. These blocks of material are integrally assembled, lapped, laminated, spliced and assembled together, tightly enclosing the yoke and a feedback temperature control system composed of a plurality of temperature measuring devices and electric heating devices arranged thereon, thereby forming Tight magnet insulation.