Magnetic-controlled capsule robot with controllable drug delivery and biopsy functions and manufacturing method thereof

Abstract

The present invention belongs to the technical field of magnetically controlled soft robots, and more specifically, relates to a magnetically controlled capsule robot with controllable drug delivery and biopsy functions and a method for manufacturing the same. The magnetically controlled capsule robot provided by the present invention comprises a robot body and a magnetic field drive control module. The robot body comprises a capsule shell, and hollow air chambers are respectively provided at both ends of the capsule shell, and a cargo cavity is provided between the hollow air chambers provided at both ends; a material transfer channel, a magnetic lock provided around the material transfer channel, and a magnetic switch valve provided in conjunction with the magnetic lock are provided on the side wall of the cargo cavity. The internal system structure and control method of the magnetically controlled capsule robot are relatively simple. The controllable drug delivery and biopsy functions of the magnetically controlled capsule robot are cleverly achieved through bidirectional magnetic control of magnetic attraction and magnetic torque. Combined with the advantages of strong magnetic manipulation penetration and unlimited action area, the magnetically controlled capsule robot provided by the present invention provides a new technical path for the multifunctionalization of capsule robots.

Description

Technical Field

[0001] The present invention belongs to the technical field of magnetically controlled soft robots, and more specifically, relates to a magnetically controlled capsule robot with controllable drug delivery and biopsy functions and a manufacturing method thereof. Background Art

[0002] Oral administration is the most commonly used route of drug delivery, but its efficacy is susceptible to the gastrointestinal environment, known as the first-pass effect, which significantly reduces drug delivery efficiency and application scenarios. For example, the key to the efficacy of live bacterial drugs such as probiotics is how they withstand gastric acid, digestive enzymes, and bile, maintaining their activity and reaching target organs. Furthermore, partial drug release in non-target areas poses a potential risk of harm to the human body.

[0003] In order to reduce the systemic side effects of drugs on humans and improve the local therapeutic effects of drugs, innovative drug release devices and on-demand drug delivery control methods have received widespread attention and research from scholars. For example, Chinese patent number: CN112604146A discloses an implantable drug delivery device based on pulsed magnetic field triggering, which includes a drug storage shell, a magnetic piston assembly, and a magnetic fixed base assembly. This invention patent uses a magnetic field as an external excitation source, which has the advantages of safety, harmlessness, and high responsiveness. However, the density of its component materials is relatively high, and the processing requirements for the mechanical structure are relatively high. There are disadvantages such as high capsule density and limited movement rate. In addition, the drug release of this drug delivery device relies solely on the drug's own osmotic effect to reach the designated target area, and the time required for drug release is relatively long.

[0004] The patent specification with publication number CN114306901A discloses a drug-loaded capsule and an implantable drug delivery device containing the drug-loaded capsule. By mixing the drug and biocompatible photosensitive material and using solid-liquid two-phase integrated photocuring three-dimensional printing technology, the capsule encapsulating the drug is formed in one step. By driving the magnet inside the drug delivery device, the drug capsules are "burst" one by one, thereby achieving the targeted release of the drug, and a multi-drug chamber structure is set to achieve the on-demand combination release of multiple types of drugs. However, the conical needle tip in its drug-loaded capsule poses certain safety risks to the tissues and organs in the patient's body, and the directional movement of the magnet can easily cause the overall deflection of the entire drug-loaded capsule, so there are certain challenges in achieving precise drug release.

[0005] Given the advantages of unlimited degrees of freedom, strong deformation capabilities, and high adaptability of magnetically controlled soft robots driven by external magnetic fields, integrating the wireless control and strong penetration of magnetically controlled soft robots into drug delivery and biopsy capsules is expected to achieve a magnetically controlled capsule robot with simpler structure, higher controllability, and higher control efficiency, which has important clinical medical value. Summary of the Invention

[0006] In view of the defects of the prior art, the purpose of the present invention is to provide a magnetically controlled capsule robot with controllable drug delivery and biopsy functions and a manufacturing method thereof, so as to solve the problems of low drug delivery efficiency, complex capsule structure and control, and insufficient safety level of the prior art magnetically controlled capsule robots.

[0007] To achieve the above-mentioned object, the present invention provides a magnetically controlled capsule robot, comprising a robot body and a magnetic field drive control module; wherein:

[0008] The robot body includes a capsule shell, wherein hollow air chambers are respectively provided at both ends of the capsule shell, a loading cavity is provided between the hollow air chambers, and the loading cavity and the hollow air chambers are isolated from each other;

[0009] A material transfer channel, a magnetic lock arranged around the material transfer channel, and a magnetic switch valve arranged in cooperation with the magnetic lock are provided on the side wall of the cargo chamber; the magnetic switch valve is a magnetized magnetic switch valve; the material transfer channel is used to enable the cargo chamber to transfer or exchange materials with the external environment when the magnetic switch valve is open; the magnetic lock and the magnetized magnetic switch valve are arranged in cooperation with each other through magnetic attraction to keep the magnetic switch valve in a closed state, thereby ensuring that the cargo chamber is isolated from the external environment when the magnetically controlled capsule robot is not working;

[0010] The magnetic field drive control module is used to apply a magnetic field force to the magnetized magnetic switch valve under the action of an external magnetic field excitation source to realize the opening or closing of the magnetic switch valve.

[0011] Preferably, the material transfer channel is one or more openings on the side wall of the capsule shell that protrude toward the inside or outside of the capsule, and a magnetic lock recess is formed between the periphery of the opening and the side wall of the capsule shell, and the magnetic lock recess is used to fix the magnetic lock; when the magnetic switch valve is in a closed state, the magnetic switch valve covers the surface of the magnetic lock and the material transfer channel, and is used to close the material transfer channel so that the cargo cavity is isolated from the external environment; the magnetic switch valve can be deformed under the control of the magnetic field drive control module to open the material transfer channel, so that the cargo cavity can transfer or exchange substances with the external environment.

[0012] Preferably, the magnetization direction of the magnetized magnetic switch valve is unidirectional magnetization or symmetrical magnetization with opposite directions at both ends; when in use, a magnetic field force is applied to the magnetized magnetic switch valve under the action of an external magnetic field excitation source, so that the magnetized magnetic switch valve is deformed under the action of the magnetic torque to achieve the opening of the magnetic switch valve.

[0013] Preferably, the external magnetic field excitation source is a permanent magnet or a Helmholtz coil.

[0014] Preferably, the cargo chamber includes two or more independent and isolated sub-carrying chambers, and the side wall of each sub-carrying chamber is provided with the material transmission channel, a magnetic lock arranged around the material transmission channel, and a magnetic switch valve arranged in conjunction with the magnetic lock, so as to realize multi-channel transmission or exchange of materials.

[0015] According to another aspect of the present invention, a method for manufacturing the magnetically controlled capsule robot is provided, comprising the following steps:

[0016] (1) Dividing the capsule shell into two parts, a base and a top cover, and using light-curing 3D printing technology to prepare the base and the top cover of the capsule shell respectively;

[0017] (2) A magnetic lock is fixedly arranged on the periphery of a material transfer channel arranged on the side wall of the cargo cavity of the capsule shell; a magnetized magnetic switch valve is arranged in conjunction with the magnetic lock, and then the base and top cover of the magnetically controlled capsule robot are packaged to obtain the magnetically controlled capsule robot.

[0018] In general, the above technical solutions conceived by the present invention have the following advantages compared with the prior art:

[0019] Beneficial effects:

[0020] (1) The present invention provides a magnetically controlled capsule robot with drug administration and biopsy functions, comprising a robot body and a magnetic field drive control module; wherein: the robot body comprises a capsule shell, hollow air chambers are respectively provided at both ends of the capsule shell, and a cargo cavity is provided between the hollow air chambers respectively provided at both ends; a material transfer channel, a magnetic lock provided around the material transfer channel, and a magnetic switch valve provided in cooperation with the magnetic lock through magnetic attraction are provided on the side wall of the cargo cavity. The internal system structure and control method of the capsule are relatively simple. The system cleverly realizes the controllable drug administration and biopsy functions of the magnetically controlled capsule robot through bidirectional magnetic control of magnetic attraction and magnetic torque. There is no complex mechanical structure inside, and the magnetic control method is used for high safety. The magnetically controlled capsule robot of the present invention is used for drug administration and biopsy sampling, and has the advantages of being painless, non-invasive, anesthesia-free, and free of cross-infection risks.

[0021] (2) The present invention can easily realize the quantitative and targeted precise drug delivery of the magnetically controlled capsule robot. In the preferred embodiment of the present invention, an external excitation magnetic field is generated by a Helmholtz coil. On the one hand, the angle of opening of the magnetic switch valve can be controlled by adjusting the amplitude of the current in the Helmholtz coil, thereby controlling the size of the drug delivery window; on the other hand, the frequency of the current in the Helmholtz coil can be adjusted to control the up and down flapping frequency of the magnetic switch valve, thereby accelerating or slowing down the exchange rate between the drug and the outside world. Therefore, the magnetically controlled capsule robot proposed in the present invention can not only accelerate the release of the drug, but also slow down the release of the drug by adjusting the amplitude and frequency of the current in the excitation coil, thereby achieving precise release of the drug and having high controllability.

[0022] (3) The capsule robot control method provided by the present invention adopts a magnetic manipulation method and has the characteristics of remote wireless drive. Due to the advantages of strong magnetic field penetration and unrestricted action area, the magnetically controlled capsule robot can achieve precise quantitative and timed drug administration and active biopsy functions, greatly improving the drug administration efficiency and drug delivery stability. In addition, the double-sided drug delivery channel design makes it possible to open the window in any magnetic field direction and to deliver multiple drugs in a mixed manner on demand.

[0023] (4) It can be reused in multiple ways. The closing and opening processes of the drug delivery channel of the magnetically controlled capsule robot in the present invention are independent of each other. After the drug in the drug delivery chamber is released or the fixed-point biopsy function is completed, the magnetically controlled capsule robot can be disinfected and recycled again, which better implements the concept of saving resources.

[0024] (5) Hollow air chambers are provided at both ends of the capsule shell of the magnetically controlled capsule robot of the present invention. The hollow air chambers can reduce the density of the entire magnetically controlled capsule robot. At the same time, the overall density of the magnetically controlled capsule robot can be regulated by adjusting the size of the hollow air chambers. The floating and sinking of the capsule robot can be achieved by adjusting the dosage of the solution in the cargo chamber, thereby ensuring that the capsule robot has a strong ability to carry drugs.

[0025] (6) The magnetic lock and magnetic switch valve in the magnetically controlled capsule robot of the present invention constitute the switch of the magnetically controlled capsule robot. Both are made of magnetic soft materials. The magnetic attraction between the magnetic lock and the magnetic switch valve closes the drug release valve or tissue fluid absorption valve of the magnetically controlled capsule. In combination with external magnetic field regulation, the magnetic switch valve is opened and closed, and different degrees of deformation correspond to different opening sizes, thereby realizing the controllable drug release and active biopsy functions of the magnetically controlled capsule robot. BRIEF DESCRIPTION OF THE DRAWINGS

[0026] Figure 1 : This is a schematic diagram of the three-dimensional structure of the magnetically controlled capsule robot provided in an embodiment of the present invention: Figure 1Content (a) is the shell of the robot body; Figure 1 Content (b) is the top cover of the robot body, Figure 1 Content (c) is the base of the robot body;

[0027] Figure 2 This is a schematic diagram of the working principle of the magnetically controlled capsule robot provided by the present invention when not administering and releasing drugs: Figure 2 Content (a) is a schematic diagram of the three-dimensional structure of the magnetic control capsule before drug administration; Figure 2 Content (b) is a schematic diagram of the three-dimensional structure of the magnetically controlled capsule when releasing drugs; Figure 2 Content (c) is the experimental result diagram when the magnetic control capsule is not administered; Figure 2 Content (d) is the experimental results of the magnetically controlled capsule releasing drugs;

[0028] Figure 3 This is a schematic diagram of the magnetization and magnetization circuit structure of the magnetic switch valve of the magnetically controlled capsule robot provided by an embodiment of the present invention;

[0029] Figure 4 This is a schematic diagram of the control of a bidirectional magnetic switch valve provided by an embodiment of the present invention: Figure 4 Content (a) is a three-dimensional structural diagram of a bidirectional magnetic switch valve; Figure 4 Content (b) is a diagram of the working principle under a positive magnetic field; Figure 4 Content (c) is a diagram of the working principle under reverse magnetic field;

[0030] Figure 5 This is a schematic diagram of the drug delivery process of the magnetically controlled capsule robot provided by an embodiment of the present invention under different external excitations: Figure 5 Content (a) is without external magnetic field; Figure 5 Content (b) is with an external magnetic field; Figure 5 Content (c) is to turn off the external magnetic field; Figure 5 Content (d) is to turn on the external magnetic field again. DETAILED DESCRIPTION

[0031] In order to make the purpose, technical solutions and advantages of the present invention more clearly understood, the present invention will be further described in detail below with reference to the accompanying drawings and embodiments. It should be understood that the specific embodiments described herein are only used to explain the present invention and are not intended to limit the present invention.

[0032] The present invention provides a magnetically controlled capsule robot, comprising a robot body and a magnetic field drive control module; wherein: the robot body comprises a capsule shell, hollow air chambers are respectively provided at both ends of the capsule shell, a cargo cavity is provided between the hollow air chambers respectively provided at both ends, and the cargo cavity is isolated from the hollow air chambers; a material transmission channel, a magnetic lock provided around the material transmission channel, and a magnetic switch valve provided in cooperation with the magnetic lock are provided on the side wall of the cargo cavity; the magnetic switch valve is a magnetized magnetic switch valve; the material transmission channel is used to enable the cargo cavity to transfer or exchange materials with the external environment when the magnetic switch valve is open; the magnetic lock and the magnetized magnetic switch valve are cooperated by magnetic attraction to keep the magnetic switch valve in a closed state, thereby ensuring that the cargo cavity is isolated from the external environment when the magnetically controlled capsule robot is not working.

[0033] The magnetic field drive control module is used to apply a magnetic field force to the magnetized magnetic switch valve under the action of an external magnetic field excitation source to realize the opening or closing of the magnetic switch valve; during operation, when the magnetic switch valve is opened, the material transfer channel can enable material transfer or exchange between the carrier cavity and the external environment.

[0034] In some embodiments, the capsule shell is produced using stereolithography 3D printing technology. Various printing methods can be used, such as separating the capsule shell into a base and a top cover, printing them separately, and then assembling them. The capsule shell is made of materials such as medical rubber or medical plastic that are biosafe and unaffected by gastrointestinal environments such as gastric acid. Specific examples include MED610 and transparent, non-fluorescent resin materials.

[0035] The magnetically controlled capsule robot of the present invention has a robot body comprising a capsule shell, wherein hollow air chambers are respectively provided at both ends of the capsule shell, and a loading cavity is provided between the hollow air chambers provided at both ends, and the loading cavity is isolated from the hollow air chambers on both sides thereof. The loading cavity is located inside the capsule shell, and when the magnetic switch valve is in a closed state, the loading cavity is a closed space, which is used for storing drug solutions or for storing biopsy tissues. The material transfer channel provided in the magnetically controlled capsule robot of the present invention serves as a window for exchanging drugs or tissue fluids between the internal loading cavity and the external environment, so that when the magnetic switch valve is opened, the drug in the loading cavity can reach the lesion area through the material transfer channel, or the tissue fluid in the target area can enter the loading cavity, thereby realizing an active biopsy function.

[0036] In some embodiments, the material transfer channel is one or more openings located on the side wall of the capsule shell and protruding toward the inside or outside of the capsule, and the periphery of the opening and the side wall of the capsule shell form a magnetic lock recess, and the magnetic lock recess is used to fix the magnetic lock; when the magnetic switch valve is in a closed state, the magnetic switch valve covers the surface of the magnetic lock and the material transfer channel, and is used to close the material transfer channel so that the cargo cavity is isolated from the external environment; the magnetic switch valve can be deformed under the control of the magnetic field drive control module to open the material transfer channel, so that the cargo cavity can transfer or exchange substances with the external environment.

[0037] In some embodiments, the magnetized magnetic switch valve is unidirectionally magnetized or symmetrically magnetized with opposite directions at both ends, thereby facilitating control of the opening and closing of the magnetic switch valve. During use, an external magnetic field excitation source applies a magnetic force to the magnetized magnetic switch valve, causing the magnetized magnetic switch valve to deform under the action of the magnetic torque, thereby achieving the opening of the magnetic switch valve.

[0038] In some embodiments, when the magnetization direction is unidirectional magnetization along one direction, the deformation is a side opening with one end tilted up; when the magnetization direction is symmetrical magnetization with opposite directions at both ends, the deformation is curling from both ends to the middle.

[0039] In some embodiments, a pulse magnetization module is used to magnetize the magnetic switch valve. The pulse magnetization module may include a pulse power supply, a magnetization coil, a discharge capacitor, a discharge switch, a freewheeling circuit and a magnetization mold; wherein the pulse power supply is used to provide an oscillating attenuation or a sinusoidal half-wave pulse current to the magnetization coil; the magnetization coil is used to magnetize the magnetic switch valve; the discharge capacitor is used to store electrical energy; the discharge switch is used to trigger the discharge circuit so that the pulse current provided by the discharge capacitor can flow into the magnetization coil; the freewheeling circuit includes a freewheeling diode and a freewheeling resistor for adjusting the current waveform; the magnetization mold is used to fix the magnetic switch valve; when the pulse magnetization module is working, the magnetization mold with the magnetic switch valve placed is set inside the magnetization coil; when an oscillating attenuation or a sinusoidal half-wave pulse current is passed through the magnetization coil, a strong pulse magnetic field is generated in the internal space of the coil, thereby performing non-oscillating magnetization or oscillating demagnetization on the magnetic switch valve placed inside the magnetization mold. Among them, when the freewheeling resistance is small (can be as low as 0), the discharge current is a non-oscillating waveform, which can generate a non-oscillating magnetic field after flowing into the coil to magnetize the magnetic switch valve.

[0040] The magnetic lock and the magnetic switch valve constitute the switch of the magnetic capsule robot of the present invention. They are all made of magnetic materials, wherein the magnetic switch valve is made of permanent magnetic materials of micron size and below (such as NdFeB, C r O2 and other magnetic particles) and soft materials (such as silicone, TPE materials, hydrogels and other materials with an elastic modulus of less than GPa), which are magnetic soft composite materials; magnetic locks are made of permanent magnetic materials and non-magnetic materials (such as silicone, TPE materials, hydrogels, etc.) at the micron level and below. Since they do not need to be deformed, the selection range of permanent magnetic materials and non-magnetic materials is wider. In addition to NdFeB magnetic particles, permanent magnetic materials can also be ferromagnetic particles, etc., and non-magnetic materials can be soft or hard materials. In some embodiments, the prefabricated mixed liquid of the magnetic lock is evenly added to the magnetic lock mold, and placed in a constant temperature box at 70°C for curing. After it is completely cured, it is demolded to obtain the manufactured magnetic lock; the preparation of the magnetic switch valve is similar.

[0041] In the magnetically controlled capsule robot of the present invention, the magnetic lock is fixedly arranged in a magnetic lock recess on the periphery of the material transfer channel, the surface of the magnetic lock is flush with the surface of the material transfer channel, and the magnetic switch valve is covered and arranged on the surface of the magnetic lock and the material transfer channel, and the two are sealed and bonded together by magnetic attraction, thereby achieving the closure of the material transfer channel, so that the cargo chamber is isolated from the external environment. There are two magnetic attraction modes between the magnetic lock and the magnetic switch valve, wherein the magnetic lock can be magnetized or not. For example, when the magnetic lock is made of permanent magnetic material, the magnetic lock can be left unmagnetized, so that a magnetic attraction similar to a magnet can be formed between the magnetic lock and the magnetic switch valve; in a preferred embodiment, in order to further enhance the attraction between the magnetic lock and the magnetic switch valve, the magnetic lock containing magnetic material can be magnetized, so that an attraction effect similar to that of a permanent magnet is generated between the magnetic lock and the magnetized magnetic switch valve.

[0042] In some embodiments, the magnetizing coil is wound by flat copper wire, with reinforcement material provided on its periphery, and the central area of its coil frame is set to be hollow, so that when the pulse current flows through the magnetizing coil, a relatively uniform axial pulse magnetic field is generated in the central area to magnetize the magnetic switch valve.

[0043] In some embodiments, a mold method is used to perform symmetrical reverse magnetization on the two ends of the magnetic switch valve. Specifically, the processed magnetic switch valve is first symmetrically folded, and then the folded magnetic switch valve is placed in a prefabricated magnetization mold groove. Finally, the magnetization mold carrying the magnetic switch valve is placed as a whole in the magnetization coil for overall axial magnetization.

[0044] In some embodiments, the external magnetic field excitation source is a permanent magnet or a Helmholtz coil.

[0045] In some embodiments, the external magnetic field excitation source applies a magnetic field force of 50 Hz or less and 100 mT or less to the magnetized magnetic switch valve, so that the magnetized magnetic switch valve is deformed under the action of the magnetic torque to achieve the opening of the magnetic switch valve.

[0046] In some embodiments, the cargo chamber includes two or more independent sub-carrying chambers, and the side wall of each sub-carrying chamber is provided with the material transmission channel, a magnetic lock arranged around the material transmission channel, and a magnetic switch valve arranged in conjunction with the magnetic lock, so as to realize multi-channel transmission or exchange of materials.

[0047] In a preferred embodiment, the cargo chamber includes a sub-cargo chamber symmetrically arranged in the upper and lower parts, which is symmetrically provided with the material transmission channel, a magnetic lock arranged around the material transmission channel, and a magnetic switch valve arranged in conjunction with the magnetic lock, so as to realize bilateral transmission or exchange of materials, thereby making it possible to mix multiple drugs.

[0048] The present invention also provides a method for manufacturing the magnetically controlled capsule robot, comprising the following steps:

[0049] (1) The robot body of the magnetically controlled capsule robot of the present invention is divided into two parts, a base and a top cover, and the base and the top cover of the capsule shell are respectively prepared by using light-curing 3D printing technology;

[0050] (2) A magnetic lock is fixedly arranged on the periphery of a material transfer channel arranged on the side wall of the cargo cavity of the capsule shell; a magnetized magnetic switch valve is arranged in conjunction with the magnetic lock, and then the base and top cover of the magnetically controlled capsule robot are packaged to obtain the magnetically controlled capsule robot.

[0051] In some embodiments, the magnetic lock is embedded in a magnetic lock recess formed by the periphery of the material transfer channel and the side wall of the capsule shell for fixed installation. Specifically, the material transfer channel provided on the capsule shell of the magnetically controlled capsule robot of the present invention can be one or more openings on the side wall of the cargo cavity of the capsule shell that protrude toward the inside of the capsule, or can be one or more openings on the side wall of the cargo cavity that protrude toward the outside of the capsule. When the opening is set to protrude inward, the periphery of the opening and the inner wall of the capsule shell form a magnetic lock recess, and at this time, the magnetic lock is embedded in the magnetic lock recess formed by the periphery of the material transfer channel and the inner wall of the capsule shell for fixed installation; when the opening is set to protrude outward, the periphery of the opening and the outer wall of the capsule shell form a magnetic lock recess, and at this time, the magnetic lock is embedded in the magnetic lock recess formed by the periphery of the material transfer channel and the outer wall of the capsule shell for fixed installation.

[0052] In some embodiments, step (2) first charges the discharge capacitor in the pulse magnetization module, and then triggers the discharge switch to discharge the magnetization coil, generating a uniform axial magnetic field in the center area of the coil to axially magnetize the folded magnetic switch valve placed in the magnetization mold as a whole, thereby obtaining a magnetic switch valve with reversely symmetrical magnetization distribution at both ends.

[0053] In some embodiments, in order to improve the controllability of the magnetic switch valve, the magnetizing voltage of the pulse power supply may be increased to ensure that the magnetized magnetic switch valve has a higher residual magnetic characteristic, thereby improving the switching capability of the magnetic switch valve.

[0054] The method for controllable drug delivery using the magnetically controlled capsule robot of the present invention specifically includes the following steps: when the magnetically controlled capsule robot containing the drug reaches the lesion, the drug is in an unreleased state due to the magnetic attraction of the magnetic lock on the magnetic switch valve; at this time, an external magnetic field excitation source is used to apply a magnetic field outside the human body so that the two ends of the magnetic switch valve are subjected to magnetic torque, and the magnetic switch valve opens to release the drug solution to the lesion for drug delivery. When the drug is fully released or the drug reaches the release amount, the magnetic field is reversed to stop drug delivery. In addition, the magnetic switch valve can be repeatedly closed and opened by repeatedly changing the magnetic field direction of the external magnetic field excitation source in the magnetic field drive control module, thereby accelerating the full release of the drug.

[0055] The method for performing biopsy sampling using a magnetically controlled capsule robot includes the following steps: Upon arrival at the target biopsy area, the magnetically controlled capsule robot uses an external magnetic field excitation source to apply a magnetic field to the outside of the human body, causing the ends of the magnetic switch valve to bend inward due to the magnetic torque, thereby opening the material transfer channel and allowing tissue fluid from the designated area to enter the loading chamber. When sufficient tissue fluid has been extracted from the loading chamber, the magnetic field of the magnetic field drive control module is reversed, thereby closing the magnetic switch valve, completing the active biopsy function of the designated area.

[0056] When the magnetically controlled capsule robot of the present invention is used for controlled drug delivery, the material transmission channel is the drug delivery channel, and the material loading chamber is the drug loading chamber. A magnetic switch valve is provided therein for releasing drugs from the magnetically controlled capsule robot and is disposed between the drug delivery channel and the drug loading chamber. When the magnetic switch valve is in the closed state, that is, the magnetic switch valve is subjected to the gradient magnetic field force of the magnetic lock, thereby ensuring that the drugs inside the magnetically controlled capsule do not exchange with the outside. When the external magnetic field of the magnetic field drive control module is applied, the magnetic torque applied to the magnetic switch valve is greater than the magnetic attraction force generated by the magnetic lock, and the magnetic switch valve changes from the closed state to the open state. Therefore, the drugs in the drug loading chamber can reach the lesion area in the human body through the drug delivery channel. Furthermore, to accelerate the release of drugs into human tissue, the magnetic switch valve can be closed and opened by repeatedly changing the magnetic field direction of the magnetic field drive control module. The flapping action of the valve is used to accelerate the exchange of drug solution with the internal tissue fluid of the human body, thereby greatly improving drug delivery efficiency.

[0057] On the other hand, if the magnetically controlled capsule robot is used for active biopsy, the function of the magnetic switch valve is to open the material transfer channel when the magnetically controlled capsule reaches the lesion area, thereby extracting tissue fluid from the designated area. When the magnetic field drive control module is not working, the magnetic switch valve is subjected to the magnetic attraction of the magnetic lock, thereby ensuring that the interior of the loading chamber is isolated from the external environment; and when the magnetic field drive control module applies an external magnetic field, the magnetic switch valve bends inward due to the action of the magnetic torque, and the material transfer channel opens, thereby allowing tissue fluid from the designated area to enter the loading chamber. When enough tissue fluid is extracted from the loading chamber, the external magnetic field of the magnetic field drive control module is reversed, thereby closing the magnetic switch valve, and completing the active biopsy function of the designated area.

[0058] The method for implementing targeted drug delivery and biopsy by the magnetically controlled capsule robot of the present invention can be achieved by using conventional imaging equipment assistance, magnetic positioning, or gastrointestinal motility timing monitoring methods used in the prior art.

[0059] The internal system structure and control method of the magnetically controlled capsule of the present invention are simple. The on-demand fixed-point drug delivery and biopsy functions of the magnetically controlled capsule are cleverly realized through the bidirectional magnetic control of magnetic attraction and magnetic torque, and the drug delivery progress can be accelerated or slowed down by controlling the amplitude and frequency of the external excitation field current. In addition, the double-sided drug delivery channel design makes it possible to open windows in any magnetic field direction and to deliver a variety of drugs in mixed dosages on demand. Combined with the advantages of strong magnetic control penetration and unlimited action area, the magnetically controlled capsule robot provided by the present invention provides a new technical path for the multifunctionalization of capsule robots.

[0060] In some embodiments, such as Figure 1As shown, the magnetically controlled capsule robot for controllable drug delivery includes a robot body, which includes a capsule shell. When manufacturing, the three-dimensional model of the capsule shell is first constructed using Solidworks software, and then the three-dimensional model is exported as an STL file. The exported file is then processed in a slicing software and then printed in a 3D printer. Considering the safety of the capsule robot, the capsule shell is printed using MED610, a material with good biocompatibility. In order to facilitate the assembly of the capsule robot, the capsule shell is divided into two parts, the top cover 1 and the base 2, as shown in FIG. Figure 1 As shown in content (a); after the magnetic switch valve and the magnetic lock are assembled to the base 2, the upper and lower parts of the capsule shell are sealed; wherein, the top cover 1 is a semi-ellipsoidal structure, consisting of two hemispherical hollow air chambers 1a and a semi-cylindrical drug delivery cavity 1b, as shown Figure 1 Content (b) shown; base 2 as Figure 1 As shown in content (c), it consists of two hemispherical hollow air chambers 2a, a magnetic lock groove 2b and a dosing channel 2c; there are two dosing channels 2c, i.e., substance transfer channels, which are openings arranged on the inner wall of the capsule shell and protruding toward the inside of the capsule, and a depression is formed around the opening and the inner wall of the capsule shell, i.e., the magnetic lock groove 2b.

[0061] like Figure 2 As shown in content (a), the magnetic lock 2d is embedded in the magnetic lock groove 2b to achieve a fixed setting. The magnetized magnetic switch valve 2e is covered and set on the surface of the magnetic lock 2d and the material transmission channel, namely the drug delivery channel 2c, to close the drug delivery channel 2c, so that the drug delivery cavity (i.e., the loading cavity) is isolated from the external environment; the magnetic switch valve 2e can be curled inward from both ends to reach the open state under the control of the magnetic field drive control module, as shown in FIG. Figure 2 As shown in content (b), it is used to open the substance transfer channel, namely the drug delivery channel 2c, to release the drug in the drug delivery chamber into the external environment for drug delivery. The top cover 1 and base 2 together form a capsule shell with a capsule shape, which is made of transparent resin material MED610. The hollow air chamber in the capsule structure is designed to reduce the density of the entire magnetically controlled capsule robot. At the same time, the capsule robot can float and sink by adjusting the solution dosage in the cargo chamber, ensuring that the capsule robot has a strong drug carrying capacity.

[0062] In some embodiments, the Figure 3 The pulse magnetization module shown, i.e., the magnetization circuit structure, realizes the symmetrical magnetization of the magnetic switch valve, specifically including the discharge capacitor 3, the discharge switch 5, the magnetization coil 7-3, the line impedance 6 (including the line resistor 6-1 and the inductor 6-2), the freewheeling circuit 4 (including the diode 4-1 and the freewheeling resistor 4-2), and the magnetization mold 7-2. Figure 3As shown, before discharge, the magnetic switch valve 2e is symmetrically folded to obtain a folded magnetic switch valve 2e, which is then placed inside the magnetization mold 7-2. The magnetization mold 7-2 and the magnetic switch valve 2e are then placed in the magnetization coil 7-3 for magnetization. Furthermore, the capacitor 3 is charged, and the discharge switch 5 is closed to discharge the magnetization coil 7-3. Based on this, a uniform pulsed magnetic field 7-1 is generated in the center of the magnetization coil 7-3, which causes the particles in the magnetic switch valve to form the radial magnetization distribution characteristics shown in Figure 9 (the magnetization directions are shown as 9-1 and 9-2, respectively).

[0063] The structural diagram of the magnetically controlled capsule robot before and after drug release is shown in the figure. Figure 2 First, the magnetically controlled capsule robot reaches the lesion through the peristaltic action of the human gastrointestinal tract. Due to the electromagnetic attraction of the magnetic lock 2d to the magnetic switch valve 2e, the drug is not released. The three-dimensional structural diagram and experimental results are shown in Figure 2. Figure 3 As shown in content (a) and content (c); at this time, a magnetic field 8 is applied to the outside of the human body through the Helmholtz coil so that both ends of the magnetic switch valve 2e are subjected to a magnetic torque, and the magnetic switch valve opens to release the drug solution to the lesion for administration. The three-dimensional structural diagram and experimental results are shown in FIG. Figure 3 As shown in contents (b) and (d), when the drug release is completed or the drug release amount is reached, the magnetic field is reversed and the drug administration is stopped. In addition, the magnetic switch valve can be repeatedly closed and opened by repeatedly changing the magnetic field direction of the control module, thereby accelerating the full release of the drug.

[0064] In some embodiments, the external magnetic field 8 used by the magnetic field drive control module to open and close the magnetic switch valve is generated by a Helmholtz coil. Preferably, when the magnetically controlled capsule robot reaches a designated location and needs to release drug, a sinusoidal pulse current is passed through the Helmholtz coil, generating an oscillating magnetic field with alternating directions to repeatedly open and close the magnetic switch valve. Simultaneously, the repeated oscillation of the magnetic switch valve accelerates the flow of the surrounding liquid, further accelerating the efficiency of drug release.

[0065] In some embodiments, the magnetically controlled capsule robot is further designed to have a double-sided drug delivery channel, that is, in addition to the drug delivery channel, magnetic lock and magnetic switch valve provided on the base of the capsule shell, a corresponding set is also provided on the top cover. Figure 4(a) Schematic diagram of the dual-channel robot's main structure, (b) a schematic diagram of its working principle in an upward magnetic field direction, and (c) a schematic diagram of its working principle in a downward magnetic field direction. 14a represents the upper drug delivery channel, and 14b represents the lower drug delivery channel. This design can further improve the flexibility and controllability of the magnetically controlled capsule robot. Specifically, when the upper magnetic switch valve 15a and the lower magnetic switch valve 15b are excited by an upward external magnetic field 15c, the upper magnetic switch valve 15a is closed due to the restraint of the capsule shell, while the lower magnetic switch valve 15b opens the lower drug delivery channel due to the magnetic torque, allowing drug release. Conversely, when the upper magnetic switch valve 16a and the lower magnetic switch valve 16b are excited by a downward external magnetic field 16c, the upper magnetic switch valve 16a opens the upper drug delivery channel due to the magnetic torque, allowing drug release, while the lower magnetic switch valve 16b remains closed due to the restraint of the capsule shell. Based on the above analysis, it can be seen that the design of such a double-sided drug delivery channel ensures that no matter whether it is under the action of the positive or reverse magnetic field, the drug delivery channel on one side of the magnetically controlled capsule robot is always in an open state. This structural design can further improve the drug delivery efficiency of the drug delivery capsule, and when a baffle is set between the top cover 1 and the base 2 of the capsule shell to isolate the upper drug delivery chamber from the lower drug delivery chamber, different drugs can be placed in the upper and lower drug delivery chambers, making it possible to deliver mixed drugs.

[0066] In other examples, in order to verify the practicality of the magnetically controlled capsule robot, the simulated drug delivery experiment is shown in the figure below. Figure 5 As shown, Figure 5 Content (a) is to put the magnetically controlled capsule robot loaded with drugs into clean water. It can be seen that when no external magnetic field is applied, the drugs 17a in the magnetically controlled capsule 17b are not released into the clean water; when an external magnetic field 18 is applied, the drugs 17a are released through the drug delivery channel, as shown in FIG. Figure 5 Further, when the external magnetic field 18 is turned off, Figure 5 As can be seen in content (c), the drug delivery channel of the magnetic control capsule 17b is in a closed state, and no obvious penetration of the drug 17a occurs; when the external magnetic field 18 is further turned on, the drug 17a in the magnetic control capsule 17b is released into the external clear water environment again, as shown in FIG. Figure 5 This drug delivery simulation experiment shows that the magnetically controlled capsule robot provided by the present invention is expected to achieve precise quantitative and timed drug delivery and has high controllability.

[0067] In other embodiments, the magnetically controlled capsule robot is used for active biopsy. Once the magnetically controlled capsule robot reaches the target biopsy area, an external magnetic field excitation source applies a magnetic field to the outside of the human body, causing the ends of the magnetic switch valve to bend inward due to the magnetic torque, opening the material transfer channel and allowing tissue fluid from the designated area to enter the loading chamber. When sufficient tissue fluid has been extracted from the loading chamber, the magnetic field of the magnetic field drive control module is reversed, closing the magnetic switch valve and completing the active biopsy function of the designated area.

[0068] The above results fully demonstrate that the present invention realizes the on-demand fixed-point drug delivery and biopsy functions of the magnetically controlled capsule through bidirectional magnetic control of magnetic attraction and magnetic torque. The drug delivery device has a simple and lightweight structure, and the magnetically controlled capsule can be remotely opened and closed repeatedly through an alternating magnetic field. It has the advantages of wireless drive and strong controllability, and has certain potential medical value.

[0069] It will be easily understood by those skilled in the art that the above description is merely a preferred embodiment of the present invention and is not intended to limit the present invention. Any modifications, equivalent substitutions, and improvements made within the spirit and principles of the present invention should be included in the scope of protection of the present invention.

Claims

1. A magnetically controlled capsule robot, characterized in that: It includes a robot body and a magnetic field drive control module; wherein: The robot body includes a capsule shell, wherein hollow air chambers are respectively provided at both ends of the capsule shell, a loading cavity is provided between the hollow air chambers, and the loading cavity and the hollow air chambers are isolated from each other; A material transfer channel, a magnetic lock arranged around the material transfer channel, and a magnetic switch valve arranged in cooperation with the magnetic lock are provided on the side wall of the cargo chamber; the magnetic switch valve is a magnetized magnetic switch valve; the material transfer channel is used to enable the cargo chamber to transfer or exchange materials with the external environment when the magnetic switch valve is open; the magnetic lock and the magnetized magnetic switch valve are arranged in cooperation with each other through magnetic attraction to keep the magnetic switch valve in a closed state, thereby ensuring that the cargo chamber is isolated from the external environment when the magnetically controlled capsule robot is not working; The magnetic field drive control module is used to apply a magnetic field force to the magnetized magnetic switch valve under the action of an external magnetic field excitation source to realize the opening or closing of the magnetic switch valve; The substance transfer channel is one or more openings on the side wall of the capsule shell that protrude toward the inside or outside of the capsule, and a magnetic lock recess is formed between the periphery of the opening and the side wall of the capsule shell, and the magnetic lock recess is used to fix the magnetic lock; When the magnetic switch valve is in a closed state, the magnetic switch valve covers the surface of the magnetic lock and the material transfer channel, and is used to close the material transfer channel so that the carrier cavity is isolated from the external environment; the magnetic switch valve can be deformed under the control of the magnetic field drive control module to open the material transfer channel, so that the carrier cavity and the external environment can transfer or exchange materials.

2. The magnetically controlled capsule robot according to claim 1, wherein: The magnetization direction of the magnetic switch valve after magnetization is unidirectional magnetization or symmetrical magnetization with opposite directions at both ends; When in use, a magnetic field force is applied to the magnetized magnetic switch valve under the action of an external magnetic field excitation source, so that the magnetized magnetic switch valve is deformed under the action of magnetic torque to realize the opening of the magnetic switch valve.

3. The magnetically controlled capsule robot according to claim 2, characterized in that: A pulse magnetization module is used to magnetize the magnetic switch valve, and the pulse magnetization module includes a pulse power supply, a magnetization coil, a discharge capacitor, a discharge switch, a freewheeling circuit and a magnetization mold; wherein, The pulse power supply is used to provide an oscillating attenuation or sinusoidal half-wave pulse current to the magnetizing coil; the magnetizing coil is used to magnetize the magnetic switch valve; the discharge capacitor is used to store electrical energy; the discharge switch is used to trigger the discharge circuit so that the pulse current provided by the discharge capacitor can flow into the magnetizing coil; the freewheeling circuit includes a freewheeling diode and a freewheeling resistor for adjusting the current waveform; the magnetizing mold is used to fix the magnetic switch valve; When the pulse magnetization module is working, the magnetization mold with the magnetic switch valve placed inside is set inside the magnetization coil; when an oscillating attenuation or sinusoidal half-wave pulse current is passed through the magnetization coil, a strong pulse magnetic field is generated in the internal space of the coil, thereby performing non-oscillating magnetization or oscillating demagnetization on the magnetic switch valve placed inside the magnetization mold.

4. The magnetically controlled capsule robot according to claim 3, characterized in that: When the mold method is used to perform unidirectional magnetization on the magnetic switch valve, the following steps are specifically included: placing the processed magnetic switch valve into a prefabricated magnetization mold, placing the magnetization mold carrying the magnetic switch valve as a whole in the magnetization coil for overall axial magnetization, and obtaining a magnetic switch valve with a unidirectional magnetization direction; When the mold method is used to perform symmetrical reverse magnetization on the magnetic switch valve at both ends, the following steps are specifically included: first, the processed magnetic switch valve is symmetrically folded, and then the folded magnetic switch valve is placed in a prefabricated magnetization mold, and finally the magnetization mold carrying the magnetic switch valve is placed as a whole in the magnetization coil for overall axial magnetization, thereby obtaining a symmetrically magnetized magnetic switch valve with opposite magnetization directions at both ends.

5. The magnetically controlled capsule robot according to claim 1, wherein: The external magnetic field excitation source is a permanent magnet or a Helmholtz coil.

6. The magnetically controlled capsule robot according to claim 1, characterized in that: The cargo chamber includes two or more independent and mutually isolated sub-carrying chambers. The side wall of each sub-carrying chamber is provided with the material transmission channel, a magnetic lock arranged around the material transmission channel, and a magnetic switch valve arranged in conjunction with the magnetic lock to realize multi-channel transmission or exchange of materials.

7. The method for manufacturing a magnetically controlled capsule robot according to any one of claims 1 to 6, wherein: The steps include: (1) Dividing the capsule shell into two parts, a base and a top cover, and using light-curing 3D printing technology to prepare the base and the top cover of the capsule shell respectively; (2) A magnetic lock is fixedly installed on the periphery of the material transfer channel provided on the side wall of the cargo cavity of the capsule shell; the magnetized magnetic switch valve is arranged in conjunction with the magnetic lock, and then the base and top cover of the magnetically controlled capsule robot are packaged to obtain the magnetically controlled capsule robot.

8. The production method according to claim 7, characterized in that: The capsule shell is made of medical polymer material.

9. The production method according to claim 7, wherein: The capsule shell is made of medical rubber or medical plastic.

10. The production method according to claim 7, wherein: The magnetic lock is made of magnetic material, and the magnetic switch valve is made of magnetic soft material.

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