Software and hardware combined magnetic resonance mammary gland intervention system for positioning focus

Abstract

The invention relates to a magnetic resonance mammary gland intervention system for positioning a focus through combination of software and hardware, and relates to a magnetic resonance imaging technology. Comprising a C-type magnetic resonance imaging system, a mammary gland intervention device installed on an examining table of the C-type magnetic resonance imaging system and focus positioning software at a computer end, and an open mammary gland coil is integrated in the mammary gland intervention device to scan mammary gland tissue in an imaging area; a doctor determines a plane according to MR images of three reference points on an outer clamping plate in the clamping plate assembly of the mammary gland intervention device, the coordinate position of a focus on the plane is calculated through positioning software, and therefore the needle inserting position on the outer clamping plate is accurately determined. Based on the C-shaped open type low-field magnetic resonance imaging platform, a doctor can directly perform intervention operation from the side edge, a patient does not need to move in the whole process, and needle inserting stability and relative position accuracy are ensured; in addition, a special mammary gland intervention device is designed to be combined with positioning software for rapid positioning, the interventional operation process is simplified, and extra injuries are reduced through accurate positioning.

Description

Technical Field

[0001] The present invention relates to the technical field of magnetic resonance imaging, in particular to a magnetic resonance breast intervention system for locating lesions by combining software and hardware. Background Art

[0002] According to statistics, breast cancer has surpassed lung cancer to become the most common cancer worldwide. Magnetic resonance imaging (MRI) is reliable and effective in detecting clinically significant breast cancer and directly localizing lesions during biopsies. Its role in minimally invasive (local) treatment of breast cancer is also becoming increasingly prominent. MRI-guided interventional therapy research has elevated the diagnosis and treatment of breast diseases from the morphological level to the tissue, cellular, and molecular levels. Compared with ultrasound or mammography, MRI has a higher sensitivity for breast cancer and does not expose patients to harmful ionizing radiation.

[0003] MRI-guided breast biopsy is currently primarily performed in closed magnet systems equipped with dedicated open coils. Due to their superior resolution and soft tissue contrast, this procedure is mostly performed in high-field MRI systems (1.5 Tesla and above). However, the high cost of high-field MRI makes it difficult for the general population to adopt it as a screening tool, which contributes to the current lack of commercially available MRI-guided biopsy and interventional systems. Traditional MRI-guided minimally invasive breast interventions involve inserting a biopsy needle from outside the breast, which limits access options and must be performed after the patient exits the magnet. Compared to large-aperture, high-field MRI systems, low-field MRI offers typical MRI contrast at a lower cost. Studies have shown that low-field MRI offers comparable sensitivity to high-field MRI, while offering higher specificity and accuracy. Open MRI scanners also offer advantages such as lower cost, maintenance-free operation, low specific absorption rate (SAR) and gradient shift, allowing physicians to continuously monitor patients and perform image-guided interventional procedures, such as breast biopsy and minimally invasive procedures. To address this issue, we present a MRI breast interventional system that combines hardware and software for lesion localization. Summary of the Invention

[0004] The purpose of the present invention is to provide a magnetic resonance breast intervention system for locating lesions by combining software and hardware.

[0005] The technical problems solved by the present invention are:

[0006] (1) How to utilize a C-type open low-field MRI platform to perform interventional procedures directly from the side, solving the existing technical problem that high-field MRI systems require repeated entry and exit, resulting in poor needle insertion accuracy and limited path selection;

[0007] (2) How to design a dedicated breast interventional device, set image reference points, and quickly calculate the grid, needle guide position, and needle insertion depth based on MR images to solve the problem of relying on the doctor's subjective experience for positioning and the complicated surgical process in existing technologies.

[0008] The present invention can be implemented through the following technical solutions: a magnetic resonance breast intervention system for lesion localization using a combination of software and hardware, comprising a C-type MRI system and a breast intervention device mounted on an examination bed, the breast intervention device comprising a base plate fixed to the examination bed, an ergonomic chest support assembly for supporting the patient's chest fixed to the top of the base plate, the base plate being divided into two chambers, each of which is integrated with an open breast coil for scanning breast tissue within the imaging area; and a splint assembly for fixing breast soft tissue is provided in each chamber;

[0009] The computing end of the C-type MRI system is also equipped with positioning software, which determines a plane based on the MR images of three reference points on the outer splint of the splint assembly of the breast intervention device, thereby accurately determining the needle insertion position on the outer splint.

[0010] A further technical improvement of the present invention is that the chest support assembly includes a chest support installed on the top of the base plate, a sternum pad is fixed to the middle part of the chest support, and a chest periphery pad is covered on the top surface of the chest support.

[0011] A further technical improvement of the present invention is that the splint assembly includes an inner splint fixed to one side of the sternum pad, the inner splint is arranged relatively parallel to the outer splint, and the distance between the outer splint and the inner splint is adjustable.

[0012] A further technical improvement of the present invention is that a pair of slide rails are horizontally and symmetrically fixed on one side of the outer splint away from the inner splint, the slide rails are slidably mounted on the bottom plate, and a detachable handle is commonly fixed on the side of the pair of slide rails away from the outer splint;

[0013] A buckle is rotatably mounted on one side of the base plate, and the buckle cooperates with a limiting groove arranged on the side of the slide rail.

[0014] A further technical improvement of the present invention is that grids are evenly arranged on the outer splint. When the lesion projection is located within the corresponding grid, a needle guide is installed within the grid to further determine the needle insertion position. The specifications of the needle guide are selected according to the lesion location and the size of the instrument.

[0015] A further technical improvement of the present invention is that: one, three and four hollow cylinders filled with biomimetic solution are respectively provided on the outer splint, and the three reference points are determined as follows:

[0016] Reference point one is the center of the corresponding hollow cylinder, reference point two is the center of the equilateral triangle formed by the lines connecting the centers of the three hollow cylinders, and reference point three is the center of the square formed by the lines connecting the four hollow cylinders.

[0017] A further technical improvement of the present invention is that a patient head support and an abdominal support cushion are respectively provided on both sides of the breast intervention device. The patient head support includes a head support base installed on the examination bed, and a head support cushion is installed on the top of the head support base.

[0018] A further technical improvement of the present invention is that the process of performing interventional surgery using the system mainly includes the following steps:

[0019] Clean related equipment and supplies and inspect the equipment, and fix the patient's breast tissue by adjusting the spacing of the splints;

[0020] MRI scans were used to obtain MRI images for lesion localization;

[0021] Use positioning software to select reference points, construct a plane coordinate system, calculate the lesion projection coordinates, and match the corresponding grid position and needle insertion position;

[0022] Use the puncture needle to reach the lesion and fix it, then scan again to obtain MR images.

[0023] Verify puncture positioning accuracy;

[0024] Finally, a biopsy needle is used to extract tissue and complete the surgery.

[0025] Compared with the prior art, the present invention has the following beneficial effects:

[0026] 1. The present invention is based on a C-type open low-field MRI platform, allowing doctors to perform interventional procedures such as puncture and tissue extraction directly from the side without moving the patient. This eliminates the repeated in-and-out steps required in high-field MRI systems, ensuring stable needle insertion and accurate relative positioning.

[0027] 2. The interventional system of the present invention is equipped with a magnetically compatible display in the magnet room, which can share the images and positioning results scanned by the computer in real time. The surgeon can also communicate with the imaging doctor through the voice communication system;

[0028] 3. By designing a dedicated breast intervention device, setting image reference points, and using lesion localization software, the needle grid, needle guide position, and needle insertion depth can be quickly calculated based on MR images, greatly reducing dependence on physician experience and simplifying the MRI-guided breast interventional surgery process. Precise positioning also reduces additional damage caused by repeated adjustments. BRIEF DESCRIPTION OF THE DRAWINGS

[0029] To facilitate understanding by those skilled in the art, the present invention is further described below with reference to the accompanying drawings.

[0030] Figure 1 A schematic diagram of the surgical configuration used in the magnetic resonance breast intervention system of the present invention;

[0031] Figure 2 This is a schematic diagram of the overall three-dimensional structure of the breast intervention device of the present invention;

[0032] Figure 3 This is a schematic diagram of the installation and connection structure of two sets of splints of the breast intervention device of the present invention;

[0033] Figure 4 This is a schematic diagram of the connection of the outer splint movement and locking structure of the breast intervention device of the present invention;

[0034] Figure 5 This is a side view of a simulated state after the external splint of the present invention fixes the soft tissue;

[0035] Figure 6 This is an image interface diagram of the lesion positioning process using the positioning software and interventional device in the present invention;

[0036] Figure 7 This is a diagram of the actual scene of positioning needle puncture in the present invention;

[0037] Figure 8 This is a schematic diagram of the post-puncture scan image presentation state of the present invention;

[0038] Figure 9 Schematic diagram of the biopsy procedure of the present invention.

[0039] In the figure: 1. C-type MRI system; 2. Breast intervention device; 3. Patient head support; 4. Patient mannequin; 5. Display; 8. Abdominal support pad; 201. Chest pad; 202. Chest support; 203. Base plate; 204. Coil compartment; 205. Outer splint; 206. Inner splint; 207. Slide rail; 208. Buckle; 209. Removable handle; 210. Sternum pad; 211. Wiring box; 301. Head support base; 302. Head support cushion; 901. Simulated lesion; 902. Reference point one; 903. Reference point two; 904. Reference point three; 905. Needle guide; 906. Image of lesion. DETAILED DESCRIPTION

[0040] In order to further illustrate the technical means and effects adopted by the present invention to achieve the predetermined purpose of the invention, the specific implementation methods, structures, features and effects of the present invention are described in detail below in conjunction with the accompanying drawings and preferred embodiments.

[0041] See also Figure 1-2As shown, a magnetic resonance breast intervention system for lesion localization using a combination of software and hardware is provided. The main body of the system comprises a C-type MRI system 1 and a breast intervention device 2. The breast intervention device 2 is mounted on an examination bed of the C-type MRI system 1 and uses a patient mannequin 4 to simulate the human body treatment state. A patient headrest 3 and an abdominal support cushion 8 are provided on both sides of the breast intervention device 2, corresponding to the head and abdomen positions of the patient mannequin 4, respectively, to ensure that the human body undergoes magnetic resonance-guided breast intervention surgery in a prone position. The patient is always in a relatively comfortable state during the surgery and is not moved due to external factors, thereby avoiding errors between the actual position and the image position, which may affect the accuracy of the surgery. A display 5 with an adjustable angle is also fixed to one side of the C-type MRI system 1, so that the doctor can directly view the synchronously transferred breast magnetic resonance images and the lesion localization results. Figure 1 The left side positions from top to bottom are respectively a top view of the breast intervention device entity, a left view of the breast intervention device entity, and a right view of the breast intervention device entity.

[0042] like Figure 2-4 The structural details of the breast interventional device 2 shown include a base plate 203 fixed to the examination bed of the C-type MRI system 1. An ergonomically designed chest support 202 is fixed to the top of the base plate 203. A sternum pad 210 is fixed to the middle of the chest support 202. The top surface of the chest support 202 is covered with a chest pad 201, which minimizes the discomfort caused to the patient by prolonged prone posture.

[0043] Two coil compartments 204 are symmetrically arranged at the opening of the bottom plate 203. Each coil compartment 204 has an integrated open breast coil for performing magnetic resonance imaging of the patient's breast. A sternum pad 210 is placed on the top of the adjacent sides of the two coil compartments 204.

[0044] Since interventional surgery requires the use of medical equipment (such as puncture needles, biopsy needles, ablation needles, scissors, etc.) to puncture the patient's breast, and the breast itself is soft tissue, in order to ensure the accuracy of the operation, splint assemblies are symmetrically arranged on both sides of the sternum pad 210 to fix the soft tissue, and each splint assembly includes an inner splint 206 and an outer splint 205, wherein the inner splint 206 is fixed on one side of the sternum pad 210, and the outer splint 205 is arranged parallel to the side of the corresponding inner splint 206, and the distance between the inner splint 206 and the outer splint 205 is adjustable, and a plurality of grids are provided on the outer splint 205, and the interventional operation can be performed by inserting the needle into the grid according to the corresponding position of the vertical projection of the lesion on the outer splint 205;

[0045] Furthermore, a pair of slide rails 207 are horizontally and symmetrically fixed to one side of each outer splint 205 away from the inner splint, and the slide rails 207 are slidably arranged on one side of the bottom plate 203, and a detachable handle 209 is fixed to the side of the pair of slide rails 207 away from the outer splint 205; a buckle 208 is rotatably installed on one side of the bottom plate 203, and the buckle 208 cooperates with the limiting groove provided on the side of the slide rail 207, thereby completing the horizontal position positioning of the slide rail 207; before performing the operation, the buckles 208 on both sides are opened according to the patient's body shape, and the slide rail 207 is moved by the detachable handle 209, thereby adjusting the distance between the outer splint 205 and the inner splint 206 to firmly fix the soft tissue, and after determining the position, the buckle 208 is closed to position the outer splint 205;

[0046] The breast coil inside the coil compartment 204 transmits signals through the outgoing wires. A wire harness box 211 is fixedly mounted on the side wall of the bottom plate 203 to receive the outgoing wires of the breast coil inside the wire harness box 211.

[0047] More specifically, the patient head support 3 includes a head support base 301 installed on the examination bed, and a head support cushion 302 is installed on the top of the head support base 301 .

[0048] In order to cooperate with the positioning software to accurately determine the location of the target lesion, the side view after the external splint 205 fixes the soft tissue is as follows Figure 5 As shown, the method for determining the target lesion location using the patient human body model 4 specifically includes:

[0049] Assuming that there is a simulated lesion 901 inside the breast of the patient mannequin 4, it is necessary to accurately locate the vertical projection position of the simulated lesion 901 on the outer splint 205 and the depth from the outer splint 205;

[0050] Three non-colinear reference points are set on the outer splint 205, labeled as reference point one 902, reference point two 903, and reference point three 904. The three reference points define a plane, and the coordinates of the simulated lesion 901 projected on the plane can be calculated, thereby locating the corresponding grid position and further determining the needle insertion position on the needle guide 905. Depending on the location of the lesion, the size of the instrument, etc., 2×2, 3×3, 4×4, etc. needle guides 905 can be selected to facilitate more precise surgical operations.

[0051] Furthermore, reference point one 902, reference point two 903, and reference point three 904 are respectively provided with one, three, and four hollow cylinders perfused with biomimetic solution. Reference point one 902 is specifically the center of the corresponding hollow cylinder, reference point two 903 is specifically the center of an equilateral triangle formed by connecting the centers of the three hollow cylinders, and reference point three 904 is specifically the center of a square formed by connecting the centers of the four hollow cylinders. It should be noted that the three reference points are established to form a plane coordinate system, thereby directly obtaining the projection coordinates of the lesion, thereby determining the grid in which the lesion is located, and accurately determining the needle insertion position after installing the needle guide 905 on the corresponding grid. When selecting a reference point, the doctor operates the mouse to select it on the positioning software. The selection method of reference point two 903 and reference point three 904, due to the presence of multiple circles, provides self-comparison and reference, smaller visual error, and higher selection accuracy than the direct selection of the center of reference point one 902, thereby improving the accuracy of coordinate system construction and the obtained needle insertion position.

[0052] like Figure 6 As shown, operate the mouse to select three reference points through the positioning software, and determine the position of the lesion projection relative to the three reference points after scanning, so as to obtain the position coordinates of the lesion in the projection plane, and then determine the grid and needle guide position for needle insertion, providing support for the doctor to perform positioning needle insertion and puncture. Figure 7 This is a scene diagram of needle puncture based on magnetic resonance images and positioning software. The lower left corner of the figure shows the puncture details.

[0053] In this embodiment, the system is used to perform magnetic resonance-guided breast biopsy procedures and lesion localization verification. The biopsy procedure is as follows: Figure 9 As shown; the surgical process and lesion localization verification process are as follows:

[0054] Step 1: Preoperative preparation

[0055] A breast biopsy is a minimally invasive procedure performed when imaging reveals a suspicious lesion but the diagnosis remains uncertain. This involves extracting tissue from the lesion for pathological examination. Because it is an invasive procedure, the breast interventional device 2 and other medical equipment must be cleaned and disinfected to medical standards before the procedure. The magnet room display 5 and the intercom system must be properly functioning, and surgical supplies and the surgeon must be in place.

[0056] Step 2: Surgical positioning

[0057] Accurately place the breast intervention device 2, and ask the patient to get on the MRI examination bed and adjust to a more comfortable prone position. After local anesthesia of the breast on the biopsy side, place the patient within the coverage of the breast coil. Adjust the position of the outer splint 205 to squeeze and fix the soft tissue, ensure that the imaging tissue is located in the center of the examination bed, and send it to the center of the magnet through laser positioning.

[0058] Step 3: MRI scan

[0059] After positioning is completed, the position of the lesion on the image is confirmed by scanning the positioning image and the breast MRI image, and then the sagittal plane of the breast is scanned to scan the MRI image. Note that the scan here should include the plane where the positioning point is located and the entire breast tissue. Appropriate sequence parameters such as layer thickness and layer spacing should be set to obtain the MR image used for lesion positioning.

[0060] Take the silicone phantom as an example, the scanned image is as follows Figure 6 The left figure shows the MR images of the layer where the reference point is located and the layer where the lesion 906 is located (the entire sequence imaging is about 10 layers, and only the target layer is shown here).

[0061] Step 4: Lesion localization

[0062] After scanning the MR image, right-click the corresponding sequence to enter the lesion localization software. The software automatically imports the image, as shown in step 3. Figure 6 As shown in the picture on the right;

[0063] Select three reference points and the target lesion according to the prompts, and determine the needle insertion grid, needle guide position, and needle insertion depth required to reach the target lesion;

[0064] Figure 6 In the illustrated embodiment, the simulated lesion 901 in the phantom is located in the second row and fourth column of the grid, the needle guide position is in the first row and second grid, and the needle insertion depth is approximately 35 mm from the surface of the outer splint 205. The positioning process is operated by the doctor on the computer side of the C-type MRI system 1 and is synchronously displayed on the display 5 in the magnet room.

[0065] Step 5: Positioning puncture

[0066] The doctor in the magnet room performs interventional surgery based on the positioning results displayed on the display 5. For breast biopsy, the doctor first uses a puncture needle to reach the lesion and fix it. The state after the needle is inserted is as follows: Figure 7 As shown, since breast tissue has a certain elasticity, although it can be fixed by squeezing, inserting the needle also requires certain experience and needs to be performed by a specialized doctor.

[0067] Step 6. Scan to confirm

[0068] After the puncture needle is inserted, scan the MR image again to confirm that the needle tip has reached the target lesion. If there is any deviation, the doctor needs to make fine adjustments based on experience or perform step 3 until the puncture needle reaches the lesion.

[0069] According to the phantom experiment, the positioning accuracy of the software and hardware designed by this system can be controlled within 2mm, reducing the damage to breast tissue caused by repeated adjustment of the needle position; after puncture, confirm the image as follows Figure 8As shown, the trajectory of the puncture needle can be clearly seen. Due to the special requirements of magnetic resonance imaging, the interventional devices here are all made of this compatible material.

[0070] Step 7: Tissue Extraction

[0071] After confirming the location of the lesion, remove the puncture needle core from the needle cannula, leaving the needle cannula in place, and replace it with a biopsy needle to insert it to the same depth to extract the lesion tissue. Repeat the extraction in small amounts and multiple times. After completion, remove the biopsy needle and needle cannula, and stop the bleeding at the needle hole. At this time, you can also scan the breast MR image after tissue extraction again to observe changes in the lesion.

[0072] Step 8: End of the operation

[0073] After the biopsy tissue is extracted, hemostasis is performed on the puncture needle site, the scan is ended, and the patient leaves the magnet room; the breast interventional device and examination bed are cleaned, and the magnetic resonance system is restored.

[0074] Related technical terms: Magnetic resonance-guided breast interventional surgery: The doctor determines the location of the lesion based on magnetic resonance breast imaging, uses a puncture needle to obtain tissue from the target lesion, or uses ablation to perform ablation treatment on the target lesion.

[0075] MRI radiofrequency coil: An electronic device consisting of multiple sets of wires that detect (oscillations in) the magnetic field when the induced current in the wires changes.

[0076] Breast MRI interventional coil: The MRI coil used for MRI-guided breast interventional surgery needs to have an open structure to facilitate doctors to perform interventional operations, and a splint to fix the soft breast tissue to prevent tissue sliding during the operation and causing deviation of the interventional operation.

[0077] The above description is merely a preferred embodiment of the present invention and does not constitute any form of limitation to the present invention. Although the present invention has been disclosed as a preferred embodiment as above, it is not intended to limit the present invention. Any person skilled in the art can make some changes or modifications to equivalent embodiments using the technical contents disclosed above without departing from the scope of the technical solution of the present invention. However, any simple modifications, equivalent changes and modifications made to the above embodiments based on the technical essence of the present invention without departing from the content of the technical solution of the present invention are still within the scope of the technical solution of the present invention.

Claims

1. A magnetic resonance breast intervention system for locating lesions by combining software and hardware, comprising a C-type MRI system (1) and a breast intervention device (2) mounted on an examination bed, characterized in that: The breast intervention device (2) comprises a base plate (203) fixed to an examination bed, an ergonomically designed chest support assembly for supporting a patient's chest being fixed on the top of the base plate (203), the base plate (203) being divided into two chambers, each chamber being integrated with an open breast coil for scanning breast tissue entering an imaging area; and a splint assembly for fixing breast soft tissue being provided in each chamber; The computing end of the C-type MRI system (1) is also provided with positioning software, which determines a plane based on MR images of three reference points on the outer splint (205) in the splint assembly of the breast intervention device, thereby accurately determining the needle insertion position on the outer splint (205).

2. The magnetic resonance breast intervention system for lesion localization using a combination of software and hardware according to claim 1, characterized in that: The chest support assembly comprises a chest support (202) installed on the top of the base plate (203), a sternum pad (210) is fixed to the middle part of the chest support (202), and a chest periphery pad (201) is installed and covered on the top surface of the chest support (202).

3. The magnetic resonance breast intervention system for lesion localization using a combination of software and hardware according to claim 1, characterized in that: The splint assembly includes an inner splint (206) fixed to one side of the sternum pad (210), the inner splint (206) is arranged relatively parallel to the outer splint (205), and the distance between the outer splint (205) and the inner splint (206) is adjustable.

4. The magnetic resonance breast intervention system for lesion localization using a combination of software and hardware according to claim 3, characterized in that: A pair of slide rails (207) are fixed horizontally and symmetrically on one side of the outer clamping plate (205) away from the inner clamping plate. The slide rails (207) are slidably mounted on the bottom plate (203). A detachable handle (209) is fixed to both sides of the pair of slide rails (207) away from the outer clamping plate (205). A buckle (208) is rotatably mounted on one side of the base plate (203), and the buckle (208) cooperates with a limiting groove provided on the side of the slide rail (207).

5. The magnetic resonance breast intervention system for lesion localization using a combination of software and hardware according to claim 1, characterized in that: Grids are evenly arranged on the outer splint (205). When the lesion projection is located in the corresponding grid, a needle guide (905) is installed in the grid to further determine the needle insertion position. The specifications of the needle guide (905) are selected according to the lesion location and the size of the instrument.

6. The magnetic resonance breast intervention system for lesion localization using a combination of software and hardware according to claim 1, characterized in that: One, three and four hollow cylinders filled with phantom solution are respectively provided on the outer splint (205), and the three reference points are determined as follows: Reference point one (902) is the center of the corresponding hollow cylinder, reference point two (903) is the center of the equilateral triangle formed by the lines connecting the centers of the three hollow cylinders, and reference point three (904) is the center of the square formed by the lines connecting the four hollow cylinders.

7. The magnetic resonance breast intervention system for lesion localization using a combination of software and hardware according to claim 1, characterized in that: A patient head support (3) and an abdominal support cushion (8) are respectively provided on both sides of the breast intervention device (2); the patient head support (3) comprises a head support base (301) installed on the examination bed, and a head support cushion (302) is installed on the top of the head support base (301).

8. The magnetic resonance breast intervention system for lesion localization using a combination of software and hardware according to claim 1, characterized in that: The process of performing interventional surgery using the system mainly includes the following steps: Clean related equipment and supplies and inspect the equipment, and fix the patient's breast tissue by adjusting the spacing between splints; MRI scans were used to obtain MRI images for lesion localization; Use positioning software to select reference points, construct a plane coordinate system, calculate the lesion projection coordinates, and match the corresponding grid position and needle insertion position; Use the puncture needle to reach the lesion location and fix it, then scan again to obtain MR images to verify the puncture positioning accuracy; Finally, a biopsy needle is used to extract tissue and complete the surgery.

Images