Magnetic anchoring and driving system and manufacturing method thereof

Abstract

The invention provides a magnetic anchoring and driving system and a manufacturing method thereof. In one embodiment, the system comprises: (a) an internal unit for placement in the body of a patient, comprising an internal frame, an internal magnetic rotor, and a functional module; and (b) an outer unit for anchoring and controlling the movement of the inner unit, comprising an outer frame, an outer magnetic rotor and a drive module.

Description

Technical Field

[0001] The present invention relates to magnetic anchoring and drive systems. Background Art

[0002] Minimally invasive surgery (MIS) is widely used in modern medicine, with clinical advantages such as short recovery time, less postoperative pain and less scarring. Magnetic anchoring and actuation systems have high potential for clinical applications, such as as auxiliary devices for minimally invasive surgery, such as the magnetic endoscope systems proposed by Cadeddu et al. and Valdastri et al. However, the anchoring distance in these systems is short and cannot cover the thickness of the body cavity. In order to increase the effective anchoring and actuation distance, larger magnets need to be used, which makes the system complicated. Multiple laboratories have developed magnetic anchoring and actuation systems for minimally invasive surgery, such as laparoscopic surgery and thoracic surgery. However, these systems have not yet been adopted clinically. One of the main problems is that the effective distance of magnetic anchoring cannot cover the entire thickness of the body cavity. Existing methods can provide an anchoring distance range of 20-50 mm, such as the systems reported by Liu et al. and Cheng et al., which use a larger magnet to anchor and actuate a capsule-shaped endoscope in the chest or abdominal cavity. However, the thickness of the chest wall of individual patients can reach 80 mm or more. Such systems can use larger external or internal magnets to increase anchoring and actuation distances. However, this would make the system bulky or result in the magnetic endoscope being unable to be placed into the chest through the intercostal space, thus requiring a larger incision.

[0003] The present invention proposes a magnet configuration that can effectively increase the anchoring and driving distances while keeping the system design compact. Many minimally invasive surgical devices face the problem of space limitations, such as endoscopes, tissue retractors, organ clamps, liquid aspirators, etc. This configuration can also provide surgeons with a large working space to operate the various instruments mentioned above, making the entire operation more convenient and reliable. The magnet configuration can achieve the advantages of increasing the anchoring distance and maintaining a compact design, so that magnetically driven instruments can be actually used in single-port video-assisted thoracoscopic surgery (VATS). Compared with traditional minimally invasive surgical devices, they can alleviate the problems of incision crowding and instrument interference for surgeons, and reduce the burden on assistants to hold and operate these devices.

[0004] The reference list lists materials published before the filing of this invention. Summary of the invention

[0005] The present invention proposes a magnetic anchoring and driving system. In one embodiment, the magnetic anchoring and driving system includes: a) an internal unit for placement into a patient's body, including an internal frame, an internal magnetic rotor and a functional module; and b) an external unit for anchoring and controlling the movement of the internal unit, including an external frame, an external magnetic rotor and a driving module; characterized in that: the internal magnetic rotor includes an internal shell, a left internal magnetic component, a middle internal magnetic component and a right internal magnetic component; the external magnetic rotor includes an external shell, a left external magnetic component, a middle external magnetic component and a right external magnetic component; the left external magnetic component and the left internal magnetic component are both radially magnetized, and the magnetization direction of the left external magnetic component is the same as the magnetization direction of the left internal magnetic component; the right external magnetic component and the The right-side internal magnetic components are all radially magnetized, and the magnetization direction of the right-side external magnetic components is the same as that of the right-side internal magnetic components; the magnetization direction of each of the left-side external magnetic components and the left-side internal magnetic components is opposite to that of the right-side external magnetic components and the right-side internal magnetic components; the middle external magnetic components and the middle internal magnetic components are all axially magnetized, and the magnetization direction of the middle external magnetic components is opposite to that of the middle internal magnetic components; each of the left-side internal magnetic components, the middle internal magnetic components and the right-side internal magnetic components are magnetically coupled with each of the left-side external magnetic components, the middle external magnetic components and the right-side external magnetic components respectively; the drive module controls the movement of the external magnetic rotor, and the movement includes rotation and translation; and the functional module provides one or more specific functions as the internal magnetic rotor moves.

[0006] The present invention further proposes a method for assembling the external magnetic rotor. In one example, the method includes the following steps: a) providing a shell made of non-ferromagnetic material; b) placing the middle external magnetic component in the middle part of the shell; c) placing and fixing an intermediate plate; d) placing two magnetic shielding plates on both sides of the middle external magnetic component to shield the magnetic field; e) assembling the left external magnetic component and the right external magnetic component; f) placing and fixing a right plate and a left plate, the left plate and the right plate being made of non-ferromagnetic material; and g) removing the two magnetic shielding plates. BRIEF DESCRIPTION OF THE DRAWINGS

[0007] Figure 1A and Figure 1BAn overview of the entire magnetic system and a simulated scenario of clinical application are shown. This includes an external mobile clamping device 1, an external unit 2, and an internal unit 3. The internal unit is placed into the patient's body through a minimally invasive surgery (MIS) incision 4-1 and anchored to the inner wall of the chest wall 4.

[0008] Figure 2A and Figure 2B The structure of the external unit 2 in one embodiment of the present invention is shown, which is composed of an external magnetic rotor 2-1, an external frame 2-2 and a driving module 2-3. The driving module 2-3 is composed of a motor 2-3-1, an upper pulley 2-3-2, a synchronous belt 2-3-3 and a lower pulley 2-3-4.

[0009] Figure 3A and Figure 3B The structure of the external magnetic rotor 2-1 in one example of the present invention is shown. In this example, the external magnet rotor 2-1 further includes a left external magnetic unit (LEPM) 2-1-1, a middle external magnetic unit (MEPM) 2-1-2 and a right external magnetic unit (REPM) 2-1-3 fixed by a left side plate 2-1-4, a rotor housing 2-1-5, a middle plate 2-1-6 and a right side plate 2-1-7.

[0010] Figure 4A and Figure 4B The structure of the outer frame 2-2 in one example of the present invention is shown. In this example, the outer frame 2-2 further includes an upper frame 2-2-1, a permalloy plate 2-2-2 on the frame, a left lower frame 2-2-3 and a right lower frame 2-2-4.

[0011] Figure 5A and Figure 5B The structure of the internal unit 3 in one example of the present invention is shown, and the structure is composed of an internal magnetic rotor 3-1, a functional module 3-2 and an internal frame 3-3. The internal magnetic rotor 3-1 further includes a left internal magnetic unit (LIPM) 3-1-1, a middle internal magnetic unit (MIPM) 3-1-2 and a right internal magnetic unit (RIPM) 3-1-3 fixed by a left shell 3-1-4, a middle shell 3-1-5 and a right shell 3-1-6. The internal frame 3-3 further includes an internal left frame 3-3-1 and an internal right frame 3-3-2.

[0012] Figure 6 Another method of placing functional modules in one example of the present invention is shown. In this example, functional module 3-2 is attached to a pneumatic corrugated hose.

[0013] Figure 7Another method of placing a functional module in an example of the present invention is shown. In this example, the functional module 3-2 is attached to a rigid connecting rod I 3-1-10, a joint 3-1-11 and a rigid connecting rod II 3-1-12.

[0014] Figure 8 Another method of placing a functional module in an example of the present invention is shown. In this example, the functional module 3-2 is attached to a flexible connecting rod 3-1-13.

[0015] Fig. 9 The magnet distribution and configuration of the magnetic system in one example of the present invention are shown, and the magnets include a left external magnetic unit (LEPM) 2-1-1, a middle external magnetic unit (MEPM) 2-1-2, a right external magnetic unit (REPM) 2-1-3, a left internal magnetic unit (LIPM) 3-1-1, a middle internal magnetic unit (MIPM) 3-1-2 and a right internal magnetic unit (RIPM) 3-1-3.

[0016] FIG. 10A to FIG. 10H The magnetic field distribution and another magnet configuration of the present invention are shown.

[0017] Fig.11A and Fig. 11B Comparison results of anchoring performance between the present invention and some other magnet configurations are shown. (A) is a graph reflecting the relationship between anchoring force (Fz) and distance; (B) is a graph reflecting the relationship between force per unit volume (FPV) and distance.

[0018] Fig.12 A to Fig.12 L shows the assembly process of the external magnetic rotor in one embodiment of the present invention, which includes seven steps. DETAILED DESCRIPTION

[0019] Magnetic force provides contactless force transmission. This allows magnetic tools placed in the body cavity to be anchored and driven by a magnetic unit outside the body. Since the magnetic field strength decays rapidly with increasing distance, the range of anchoring and effective driving using magnetic coupling is limited. This patent discloses a magnetic coupling method that can effectively increase the anchoring and driving range. Using this method, an example for minimally invasive surgery is designed.

[0020] The magnetic system consists of two parts, an internal unit placed inside the patient's body and an external unit outside the patient's body. Both the internal unit and the external unit contain magnetic components. The external unit is driven by an external mobile clamping device to anchor the internal unit to the inner wall of the patient's body cavity by magnetic coupling and drive the internal unit to move and rotate.

[0021] The external unit consists of an external magnetic rotor, an external frame, and a drive module. The external magnetic rotor contains the external magnetic unit (EPM), including a portion of an axially magnetized middle EPM (i.e., middle EPM, MEPM) and a radially magnetized EPM on each side (left EPM, LEPM; and right EPM, REPM). All EPMs are fixed to the housing of the external magnetic rotor. The external magnetic rotor is connected to an external frame and can rotate around its central axis with the help of the drive module. The internal unit consists of an internal magnetic rotor, a functional module, and an internal frame. The internal magnetic rotor contains the internal magnetic unit (IPM), including an axially magnetized middle internal magnetic unit (i.e., middle IPM, MIPM) and a radially magnetized IPM on each side (left IPM, LIPM; and right IPM, RIPM). All IPMs are fixed to the housing of the internal magnetic rotor. The functional module integrates a camera, an inertial measurement unit (IMU), light-emitting diodes, and other components to provide images, directional feedback, lighting, and other information or conditions during surgery. The internal magnetic rotor would be connected in some way to the internal frame and would be able to rotate around its central axis.

[0022] The present invention provides a magnetic anchoring and driving system. In one embodiment, the magnetic anchoring and driving system includes: a) an internal unit for placement into a patient's body, including an internal frame, an internal magnetic rotor and a functional module; and b) an external unit for anchoring and controlling the movement of the internal unit, including an external frame, an external magnetic rotor and a driving module; characterized in that the internal magnetic rotor includes an internal shell, a left internal magnetic component, a middle internal magnetic component and a right internal magnetic component; the external magnetic rotor includes an external shell, a left external magnetic component, a middle external magnetic component and a right external magnetic component; the left external magnetic component and the left internal magnetic component are both radially magnetized, and the magnetization direction of the left external magnetic component is the same as the magnetization direction of the left internal magnetic component; the right external magnetic component and the right The internal magnetic components are all radially magnetized, and the magnetization direction of the right external magnetic component is the same as that of the right internal magnetic component; the magnetization direction of each of the left external magnetic component and the left internal magnetic component is opposite to that of the right external magnetic component and the right internal magnetic component; the middle external magnetic component and the middle internal magnetic component are all axially magnetized, and the magnetization direction of the middle external magnetic component is opposite to that of the middle internal magnetic component; each of the left internal magnetic component, the middle internal magnetic component and the right internal magnetic component is magnetically coupled with each of the left external magnetic component, the middle external magnetic component and the right external magnetic component respectively; the drive module controls the movement of the external magnetic rotor, and the movement includes rotation and translation; and the functional module provides one or more specific functions as the internal magnetic rotor moves.

[0023] In one example, the left outer magnetic component, the middle outer magnetic component, the right outer magnetic component, the left inner magnetic component, the middle inner magnetic component or the right inner magnetic component comprises one or more magnets. In another example, the one or more magnets may be permanent magnets, electromagnets or soft magnetic materials.

[0024] In one instance, the shape of the left inner magnetic component, the right inner magnetic component, the left outer magnetic component, the right outer magnetic component, the middle inner magnetic component or the middle outer magnetic component can be a cylinder, a semi-cylinder, a cuboid, a sphere, a hemisphere or an ellipsoid.

[0025] In one example, the inner housing secures the left inner magnetic assembly, the middle inner magnetic assembly, and the right inner magnetic assembly.

[0026] In one example, the internal magnetic rotor is connected to the internal frame via a first connection mechanism so as to be rotatable around a rotor central axis. In one example, the first connection mechanism may be one or more of a bearing, a shaft, a flexible structure, or a soft structure.

[0027] In one example, the one or more specific functions may be illumination, imaging, tissue / organ traction, instrument manipulation, or fluid aspiration.

[0028] In one example, the method of attaching the functional module to the internal magnetic rotor may be one or more of glue, a movable joint, or a flexible / soft structure.

[0029] In one instance, the external shell includes a shell, a left side plate, a middle plate and a right side plate, which are respectively used to fix the left external magnetic component, the middle external magnetic component and the right external magnetic component; the shell, the left side plate and the right side plate are made of non-ferromagnetic material.

[0030] In one example, the external magnetic rotor further comprises one or more embedded sensors for measuring position and motion. In another example, the one or more embedded sensors may be an inertial measurement unit, a gyroscope, an accelerometer, a Hall sensor, an encoder, or an optical marker.

[0031] In one example, the outer magnetic rotor is connected to the outer frame by a second connection mechanism to achieve rotation around a central axis. In another example, the second connection mechanism is selected from one or more of a bearing, a shaft, a flexible structure or a soft structure.

[0032] In one example, the drive module includes a driver for rotating the external magnetic rotor and an external holding device for moving the external magnetic rotor in space. In another example, the driver includes a motor. In a further example, the external holding device includes a robotic arm.

[0033] The present invention further provides a method for assembling the external magnetic rotor. In one example, the method includes the following steps: a) providing a shell made of non-ferromagnetic material; b) placing the middle external magnetic component in the middle part of the shell; c) placing and fixing an intermediate plate; d) placing two magnetic shielding plates on both sides of the middle external magnetic component to shield the magnetic field; e) assembling the left external magnetic component and the right external magnetic component; f) placing and fixing a right plate and a left plate, the left plate and the right plate being made of non-ferromagnetic material; and g) removing the two magnetic shielding plates.

[0034] In one example, the magnetic shielding plate is made of Permalloy.

[0035] The present invention will be better understood by reference to the following experimental details, but those skilled in the art will immediately recognize that the specific experiments described are for illustrative purposes only and are not intended to limit the invention described herein, which will be defined by the claims that follow.

[0036] Throughout this application, various references or publications are cited. The entire contents of these references or publications are incorporated into this application by reference to more fully describe the current state of the art to which the present invention belongs. It should be noted that the transitional term "comprising", with its synonyms "including", "containing" or "characterized by", is inclusive or open-ended and does not exclude additional, undescribed elements or method steps.

[0037] Detailed description of the operation / function of the present invention

[0038] Figure 1A and Figure 1B The application scenario of the magnetic system of the present invention in minimally invasive surgery (MIS) is demonstrated. At the beginning of the operation, the internal unit 3 is placed into the patient's body through the minimally invasive surgical incision 4-1 and is anchored on the inner wall of the patient's body cavity by the attraction generated by the external unit 2. Next, the external unit 2 controlled by the external mobile clamping device 1 will move to drag the internal unit 3 to the desired position. As the operation proceeds, the external unit 2 can guide the internal unit 3 to translate and rotate to perform corresponding movements to meet the needs of the surgeon. Finally, the internal unit 3 will move to the vicinity of the minimally invasive surgical incision 4-1 and be taken out.

[0039] Figure 2A and Figure 2B A diagram of an external unit 2 is shown, which is further composed of an external magnetic rotor 2-1, an external frame 2-2 and a driving module 2-3. In this driving module 2-3, the motor 2-3-1 is fixed to the external frame 2-2. The upper pulley 2-3-2 is fixed to the motor 2-3-1 and connected to the lower pulley 2-3-4 through a synchronous belt 2-3-3. The lower pulley is fixed to the magnetic rotor 2-1. Therefore, when the motor 2-3-1 is running, it will be able to drive the magnetic rotor to rotate.

[0040] Figure 3A and Figure 3BThe composition of the magnetic rotor 2-1 is shown. The magnetic rotor 2-1 has three magnets. The magnetization direction of the left magnet (LEPM 2-1-1) is from bottom to top. The magnetization direction of the middle part magnet (MEPM 2-1-2) is from left to right. The magnetization direction of the right magnet (REPM 2-1-3) is from top to bottom. All the magnets are placed on the rotor housing 2-1-5. The left side plate 2-1-4 connected to the rotor housing 2-1-5 is used to fix the LEPM 2-1-1. The middle plate 2-1-6 connected to the rotor housing 2-1-5 is used to fix the MEPM 2-1-2. The right side plate 2-1-7 connected to the rotor housing 2-1-5 is used to fix the REPM 2-1-3.

[0041] Figure 4A and Figure 4B An example of the external frame of the present invention is shown. The upper frame 2-2-1 fixes the motor 2-3-1 to drive the magnetic rotor 2-1, and there is a permalloy plate 2-2-2 on the frame to shield the influence of the magnetic field on the motor 2-3-1. The lower left frame 2-2-3 and the lower right frame 2-2-4 are connected to the upper frame 2-2-1 to fix the magnetic rotor 2-1.

[0042] Figure 5A and Figure 5B An example of the internal unit 3 of the present invention is shown. The internal unit 3 is composed of an internal magnetic rotor 3-1, a functional module 3-2 and an internal frame 3-3. The internal magnetic rotor 3-1 has three magnets. The magnetization direction of the magnet on the left (LIPM 3-1-1) is from bottom to top. The magnetization direction of the magnet in the middle part (MIPM 3-1-2) is from left to right. The magnetization direction of the magnet on the right (REPM 3-1-3) is from top to bottom. The left shell 3-1-4 is used to fix the LIPM 3-1-1. The middle shell 3-1-5 is used to fix the LIPM 3-1-2. The right shell 3-1-6 is used to fix the RIPM 3-1-3. The internal left frame 3-3-1 and the internal right frame 3-3-2 are connected to each other to fix the internal magnetic rotor 3-1 that can rotate around its own central axis. The functional module 3-2 is placed in the lower half of the middle part of the internal unit 3. It can provide images, direction feedback, lighting and other information or functions during surgery.

[0043] Figure 6Another example of the internal unit 3 of the present invention is shown. The magnetization direction of the magnet on the left (LIPM 3-1-1) is from bottom to top. The magnetization direction of the magnet in the middle part (MIPM 3-1-2) is from left to right. The magnetization direction of the magnet on the right (REPM 3-1-3) is from top to bottom. The left shell 3-1-4 is used to fix the LIPM 3-1-1. The middle shell 3-1-5 is used to fix the LIPM 3-1-2. The right shell 3-1-6 is used to fix the RIPM 3-1-3. The stretchable pneumatic bellows I 3-1-7 is attached to the torque coil 3-1-9. The torque coil 3-1-9 can be rotated to provide a rotational degree of freedom. The flexible pneumatic bellows II 3-1-8 is attached to the pneumatic bellows I 3-1-7. The functional module 3-2 is attached to the pneumatic bellows II 3-1-8.

[0044] Figure 7 Another example of the internal unit 3 of the present invention is shown. The magnetization direction of the magnet on the left (LIPM 3-1-1) is from bottom to top. The magnetization direction of the magnet in the middle part (MIPM 3-1-2) is from left to right. The magnetization direction of the magnet on the right (REPM 3-1-3) is from top to bottom. The left shell 3-1-4 is used to fix the LIPM 3-1-1. The middle shell 3-1-5 is used to fix the LIPM 3-1-2. The right shell 3-1-6 is used to fix the RIPM 3-1-3. The rigid connecting rod I 3-1-10 is attached to the right shell 3-1-6. The joint 3-1-11 that can be driven by a magnetic field or a motor is attached to the rigid connecting rod I 3-1-10. The rigid connecting rod II 3-1-12 is attached to the joint 3-1-11. And, the functional module 3-2 is attached to the rigid connecting rod II 3-1-12.

[0045] Figure 8 Another example of the internal unit 3 of the present invention is shown. The magnetization direction of the magnet on the left (LIPM 3-1-1) is from bottom to top. The magnetization direction of the magnet in the middle part (MIPM 3-1-2) is from left to right. The magnetization direction of the magnet on the right (REPM 3-1-3) is from top to bottom. The left shell 3-1-4 is used to fix the LIPM 3-1-1. The middle shell 3-1-5 is used to fix the LIPM 3-1-2. The right shell 3-1-6 is used to fix the RIPM 3-1-3. The flexible connecting rod 3-1-13 is attached to the right shell 3-1-6. The flexible connecting rod 3-1-13 can be a soft magnetic material, a flexible structure driven by a cable, etc. The functional module 3-2 is attached to the flexible connecting rod 3-1-13.

[0046] Of course, for functional modules, there are many other variations based on this magnet configuration, such as tissue retractors, organ grippers, liquid aspirators, etc. They can also be placed in the patient's body and anchored on the inner wall of the body cavity to perform different functions. This design can also enhance their anchoring distance and working stability.

[0047] Fig. 9 The magnet distribution and configuration of the magnetic system of the present invention are shown. The magnetization direction of LEPM 2-1-1 and LIPM 2-1-3 is opposite to that of REPM 3-1-1 and RIPM 3-1-3, resulting in a repulsive force between LEPM 2-1-1 and RIPM 3-1-3, as well as a repulsive force between REPM 2-1-3 and LIPM 3-1-1. This effect will significantly weaken the attractive force applied to the internal unit, resulting in a shortened anchoring distance between the bottom of the external magnetic unit (EPMs) and the top of the internal magnetic unit (IPMs). Therefore, MEPM 2-1-2 and MIPM 3-1-2 are introduced to improve the anchoring performance of the capsule. The magnetic coupling between them can generate additional attractive force to enhance the anchoring performance. In addition, MEPM 2-1-2 can also attract LIPM 3-1-1 and RIPM 3-1-3, just as MIPM 3-1-2 can be attracted by LEPM 2-1-1 and REPM 2-1-3, providing additional anchoring force.

[0048] The design optimization of the magnet configuration of the present invention mainly involves the size, shape and strength of the magnets, as well as the distance between the magnets in a rotor. These parameters can be determined according to the requirements of the working distance and range of motion. The performance of the system can be evaluated by theoretical analysis and finite element analysis. At the same time, the difficulty of assembly, manufacturing process and cost should also be considered.

[0049] FIG. 10A to FIG. 10H The magnetic field distribution of different magnet configurations is shown. In the YZ plane, a test area below the EPMs was selected for evaluation. The size of the test area was 100 mm × 50 mm, and the sampling interval was set to 1 mm (e.g. Fig. 10A Then, the norm of the magnetic field strength distributed in the area is calculated by the theoretical model. The magnetic dipole model is used here to obtain the magnetic field conditions. The magnetic field strength generated by the a-th EPM at the b-th position can be obtained by the following equation: Where μ0 is the magnetic permeability of vacuum, which is a constant; is an identity matrix; represents the magnetic moment vector of the ath EPM at the initial position; is the rotation matrix of the external magnetic rotor. Then the magnetic fields of all EPMs are superimposed and the norm of the magnetic field is calculated to obtain Fig. 10B To verify the theoretical model, finite element analysis was also performed. Fig. 10C Display the results, Fig. 10D The error is shown. The results of the model and simulation are very consistent. Fig. 10E and Fig.10F The magnetic field distribution is compared by selecting another magnet configuration. The overall magnetic field distribution of the two designs is shown in Figure 10G and Fig. 10H The magnet configuration of the present invention can significantly enhance the magnetic field, surpassing some other existing magnet configurations.

[0050] Fig.11A and Fig. 11B The remanence of the EPM and IPM in the selected magnet configurations is set to be the same. After experimental verification, a curve reflecting the relationship between the anchoring force and the distance between the inner and outer rotors is obtained from the magnetic theory model calculation. The resultant force acting on the IPM in the magnetic field can be calculated by the following equation: in represents the magnetic moment of the bth IPM in the initial position. is the rotation matrix of the internal magnetic rotor. The force calculation can be further converted to: where r ab =P b -P a Used to represent the space vector from the ath external magnetic dipole to the bth internal magnetic dipole. Represents r ab The normalized vector of . Fig.11A Results of anchoring forces for different magnet configurations are shown.

[0051] Of course, the volumes of magnets in different configurations are not exactly the same, so a unified evaluation metric is proposed, called the attractive force per unit volume (FPV):

[0052] This indicator includes the two most important aspects of VATS clinical application: the miniaturization of the internal unit to allow insertion through a narrow incision and the ability to generate sufficient anchoring force to fix the internal unit to the thick wall of the body cavity. Fig. 11BThe comparison results show that the proposed magnet configuration can significantly enhance the anchoring performance, with the average increases in attraction and attraction per unit volume (FPV) being 96.76% and 55.82%, respectively.

[0053] Fig.12 The assembly process is shown. During this process, it is necessary to overcome the huge repulsive force between the magnets. The present invention provides an assembly method to overcome this problem: Step 1. Prepare the rotor housing 2-1-5. Step 2. Place the MEPM 2-1-2 in the middle portion of the rotor housing 2-1-5. Step 3. Place the intermediate plate 2-1-6 and fix it on the rotor housing 2-1-5. Step 4. Place two Permalloy plates 2-1-8 on both sides of the MEPM 2-1-2 to shield the magnetic field. Step 5. Assemble LEPM 2-1-1 and REPM 2-1-3. Step 6. Place the left side plate 2-1-4 and the right side plate 2-1-7 and fix them on the rotor housing 2-1-5. Step 7. Remove the Permalloy plates 2-1-8 of both rotors.

[0054] Regarding the working principle of the system, by utilizing the magnetic coupling between the EPM and the IPM, this configuration can achieve rotational and translational motion while anchoring the capsule to the inner wall of the body cavity. The rotation of the internal unit includes pan and roll motion, and is achieved by the torque applied by the EPM around the corresponding axis. The pan torque and roll torque acting on the capsule are generated by changing the magnetic field of the EPM coupled to the IPM by rotating the external unit along the corresponding axis. The translational motion of the internal endoscope is performed on the curved surface of the chest wall, and the required magnetic force should be along the corresponding axis. The movement of the external unit over the patient's body cavity can generate a translational force.

[0055] Manufacturing method

[0056] For magnets, they can be permanent magnets, electromagnets, soft magnetic materials, etc. They can be made in the laboratory, bought from the store or produced by the factory. For shells, plates and frames, they can be made of high-strength materials and connected by high-stability methods. References 1. US Pat. No. 6,902,528B1. Method and apparatus for magnetically controlling catheters in body lumens and cavities, 18 Feb. 2003. 2.J.Cadeddu,R.Fernandez,M.Desai,R.Bergs,C.Tracy,S.-J.Tang,P.Rao,M.Desai,and D.Scott,“Novel magnetically guided intraabdominal camera tofacilitate laparoendoscopic single-site surgery:initial human experience,”Surgical endoscopy,vol.23,no.8,pp.1894–1899,2009. 3.M.Simi,M.Silvestri,C.Cavallotti,M.Vatteroni,P.Valdastri,A.Menciassi,and P.Dario,“Magnetically activated stereoscopic vision systemfor laparoendoscopic single-site surgery,”IEEE / ASME Transactions onMechatronics,vol.18,no.3,pp.1140–1151,2012. 4.M.Simi,R.Pickens,A.Menciassi,S.D.Herrell,and P.Valdastri,“Fine tilttuning of a laparoscopic camera by local magnetic actuation:Two-portnephrectomy experience on human cadavers,”Surgical innovation,vol.20,no.4,pp.385–394,2013. 5.N.Garbin,P.R.Slawinski,G.Aiello,C.Karraz,and P.Valdastri,“Laparoscopic camera based on an orthogonal magnet arrangement,”IEEE Roboticsand Automation Letters,vol.1,no.2,pp.924–929,2016. 6.X.Liu,G.J.Mancini,and J.Tan,“Design of a unified active locomotionmechanism for a wireless laparoscopic camera system,”in 2014IEEE / RSJInternational Conference on Intelligent Robots and Systems.IEEE,2014,pp.1294–1301 7.X.Liu,G.J.Mancini,and J.Tan,“Design of a unified active locomotionmechanism for a capsule-shaped laparoscopic camera system,”in 2014 IEEEInternational Conference on Robotics and Automation(ICRA).IEEE,2014,pp.2449–2456. 8.H.Wei,W.Tan,K.Li,and D.Xu,“Design and modeling of a magneticallyactuated laparoscopic robot,”in 2019 14th IEEE Conference on IndustrialElectronics and Applications(ICIEA).IEEE,2019,pp.149–154. 9.T.Cheng,C.S.H.Ng,P.W.Y.Chiu,and Z.Li,“Design and prototyping of asoft magnetic anchored and guidance endoscope system,”in 2017 IEEE / RSJInternational Conference on Intelligent Robots and Systems(IROS).IEEE,2017,pp.2902–2908. 10.T.Cheng,X.Zhang,C.S.H.Ng,P.W.Y.Chiu,and Z.Li,“A novel magneticanchored and steered camera robot for single port access surgery,”in 2018IEEE International Conference on Robotics and Automation(ICRA).IEEE,2018,pp.1406–1412. 11.X.Liu,G.J.Mancini,Y.Guan,and J.Tan,“Design of a magnetic actuatedfully insertable robotic camera system for single-incision laparoscopicsurgery,”IEEE / ASME Transactions on Mechatronics,vol.21,no.4,pp.1966–1976,2015. 12.T.Cheng,W.Li,C.S.H.Ng,P.W.Y.Chiu,and Z.Li,“Visual servo control ofa novel magnetic actuated endoscope for uniportal videoassisted thoracicsurgery,”IEEE Robotics and Automation Letters,vol.4,no.3,pp.3098–3105,2019. 13.T.Cheng,W.Li,W.Y.Ng,Y.Huang,J.Li,C.S.H.Ng,P.W.Y.Chiu,and Z.Li,“Deep learning assisted robotic magnetic anchored and guided endoscope forreal-time instrument tracking,”IEEE Robotics and Automation Letters,vol.6,no.2,pp.3979–3986,2021. 14.U.S.Pat.No.8,084,898 B2.Magnetic actuator,magnetic actuatoroperating method,and capsule endoscope using the same,27 Dec.2011. 15.U.S.Pat.No.11,033,183 B2.Wireless magnetically steerableendoscope,15 Jun.2021.

Claims

1. A magnetic anchoring and actuation system, comprising: a. an internal unit for placement into a patient's body, comprising an internal frame, an internal magnetic rotor and a functional module; as well as b. an external unit for anchoring and controlling the movement of the internal unit, comprising an external frame, an external magnetic rotor and a drive module; Features: The internal magnetic rotor includes an internal housing, a left internal magnetic unit, a middle internal magnetic unit and a right internal magnetic unit; The external magnetic rotor includes an external housing, a left external magnetic unit, a middle external magnetic unit and a right external magnetic unit; The left outer magnetic unit and the left inner magnetic unit are both radially magnetized, and the magnetization direction of the left outer magnetic unit is the same as the magnetization direction of the left inner magnetic unit; The right outer magnetic unit and the right inner magnetic unit are both radially magnetized, and the magnetization direction of the right outer magnetic unit is the same as the magnetization direction of the right inner magnetic unit; The magnetization direction of each of the left outer magnetic unit and the left inner magnetic unit is opposite to the magnetization direction of the right outer magnetic unit and the right inner magnetic unit; The intermediate outer magnetic unit and the intermediate inner magnetic unit are both axially magnetized, and the magnetization direction of the intermediate outer magnetic unit is opposite to the magnetization direction of the intermediate inner magnetic unit; Each of the left inner magnetic unit, the middle inner magnetic unit and the right inner magnetic unit is magnetically coupled to each of the left outer magnetic unit, the middle outer magnetic unit and the right outer magnetic unit respectively; The drive module controls the movement of the external magnetic rotor, the movement including rotation and translation; as well as The functional module provides one or more specific functions in response to the movement of the internal magnetic rotor.

2. The system according to claim 1, characterized in that: The left outer magnetic unit, the middle outer magnetic unit, the right outer magnetic unit, the left inner magnetic unit, the middle inner magnetic unit or the right inner magnetic unit includes one or more magnetic parts.

3. The system according to claim 2, characterized in that: The one or more magnetic parts are selected from permanent magnets, electromagnets or soft magnetic materials.

4. The system according to claim 1, characterized in that: The shape of the left inner magnetic unit, the right inner magnetic unit, the left outer magnetic unit, the right outer magnetic unit, the middle inner magnetic unit or the middle outer magnetic unit is selected from a cylinder, a semi-cylinder, a cuboid, a sphere, a hemisphere or an ellipsoid.

5. The system according to claim 1, characterized in that: The inner housing fixes the left inner magnetic unit, the middle inner magnetic unit, and the right inner magnetic unit.

6. The system according to claim 1, characterized in that: The internal magnetic rotor further includes one or more onboard sensors for measuring position and motion.

7. The system according to claim 6, characterized in that: The one or more onboard sensors are selected from an inertial measurement unit, a gyroscope, an accelerometer, a Hall sensor, or an optical marker.

8. The system according to claim 1, characterized in that: The inner magnetic rotor is connected to the inner frame via a first connection mechanism so as to be rotatable about a rotor central axis.

9. The system according to claim 8, characterized in that: The first connection mechanism is selected from one or more of a bearing, a shaft, a flexible structure or a soft structure.

10. The system according to claim 1, characterized in that: The one or more specific functions are selected from illumination, imaging, tissue / organ traction, instrument manipulation or fluid aspiration.

11. The system according to claim 1, characterized in that: The method of attaching the functional module to the internal magnetic rotor is selected from one or more of glue, movable joints or flexible / soft structures.

12. The system according to claim 1, characterized in that: The external shell includes a shell, a left side plate, a middle plate and a right side plate, which are respectively used to fix the left external magnetic unit, the middle external magnetic unit and the right external magnetic unit; the shell, the left side plate and the right side plate are made of non-ferromagnetic materials.

13. The system according to claim 1, characterized in that: The external magnetic rotor further includes one or more onboard sensors for measuring position and motion.

14. The system according to claim 13, characterized in that: The one or more embedded sensors are selected from an inertial measurement unit, a gyroscope, an accelerometer, a Hall sensor, an encoder, or an optical marker.

15. The system according to claim 1, characterized in that: The outer magnetic rotor is connected to the outer frame by a second connection mechanism so as to be rotatable about a rotor central axis.

16. The system according to claim 15, characterized in that: The second connection mechanism is selected from one or more of a bearing, a shaft, a flexible structure or a soft structure.

17. The system according to claim 1, characterized in that: The drive module includes a drive for rotating the external magnetic rotor and an external mobile clamping device for manipulating the external magnetic rotor.

18. The system according to claim 17, characterized in that: The drive includes a motor.

19. The system according to claim 17, characterized in that: The external mobile clamping device includes a mechanical arm.

20. A method for assembling the external magnetic rotor in the system of claim 1, characterized in that: The method comprises the following steps: a. Provide a shell made of non-ferromagnetic material; b. placing the intermediate external magnetic unit in the middle portion of the housing; c. Place and fix an intermediate plate; d. inserting two magnetic shielding plates respectively on both sides of the intermediate external magnetic unit to shield the magnetic field; e. Assembling the left external magnetic unit and the right external magnetic unit; f. Place and fix a right side plate and a left side plate, the left side plate and the right side plate are made of a non-ferromagnetic material; and g. Remove the two magnetic shielding plates.

21. The method according to claim 20, characterized in that: The magnetic shielding plate is made of Permalloy.

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