Medical magnetic drive capsule endoscope coated with lubricating soft shell and preparation method thereof

Abstract

The application relates to a medical magnetic driving capsule endoscope coated with a lubricated soft shell and a preparation method thereof. The medical magnetic driving capsule endoscope comprises an inner shell, an endoscope assembly, a water-soluble protective cover, a medicine applying assembly and a hydrogel shell. The inner shell has a sealed cavity and a medicine applying cavity. The endoscope assembly is located in the sealed cavity and comprises a camera module and an illumination module. The inner shell is provided with a medicine applying window which is communicated with the medicine applying cavity and faces a second direction. The water-soluble protective cover is connected with the inner shell and covers the medicine applying window. The medicine applying assembly is located in the medicine applying cavity. The hydrogel shell is coated outside the inner shell and is provided with a medicine applying opening, a camera opening and an illumination opening. During the travel of the medical magnetic driving capsule endoscope in the intestinal tract of a patient, the friction between the hydrogel shell and the intestinal wall is small, the intestinal wall is not easily damaged by friction, the safety and comfort are improved, and the travel speed of the medical magnetic driving capsule endoscope is improved, and the inspection efficiency is improved.

Description

Technical Field

[0001] This application relates to the field of medical device technology, and in particular to a medical magnetically driven capsule endoscope with a lubricated soft shell and a method for its preparation. Background Technology

[0002] Capsule endoscopy is a new type of medical device specifically designed for the examination and diagnosis of the digestive tract. It consists of a camera module, a wireless transmission module, and a power supply module housed in a swallowable capsule, enabling comprehensive examination of the patient's digestive tract.

[0003] Compared to traditional endoscopy, capsule endoscopy offers a non-invasive, convenient, and comfortable examination method, reducing the discomfort and risks associated with traditional examinations to some extent. Capsule endoscopy can capture high-quality images as it passes through the digestive tract and transmit them wirelessly to an external receiving device, allowing doctors to comprehensively examine the entire digestive tract, including the esophagus, stomach, small intestine, and large intestine, especially the small intestine, which is difficult to reach with traditional endoscopy.

[0004] The movement of a capsule endoscope within the intestine typically relies on the natural peristalsis of the intestine. However, the intestinal environment varies from patient to patient, and passive, random intestinal movement can significantly affect the stability of the captured images, increasing the likelihood of missed diagnoses and potentially causing capsule retention. To address these issues, researchers have developed various active movement methods for capsule endoscopes, among which magnetic actuation stands out as an ideal solution due to its high integration and space utilization.

[0005] In related technologies, magnetically driven capsule endoscopes are inevitably dragged by magnetic forces as they travel through a patient's intestines. The friction between the capsule shell and the intestinal wall is relatively large, which can easily cause frictional damage to the intestinal wall and reduce the travel speed of the magnetically driven capsule endoscope. Summary of the Invention

[0006] Based on this, it is necessary to address the technical problem in related technologies where magnetically driven capsule endoscopes are inevitably dragged by magnetic forces during their movement in the patient's intestines, and the friction between the capsule shell and the intestinal wall is relatively large, which can easily cause frictional damage to the intestinal wall, reduce the movement speed of the magnetically driven capsule endoscope, and pose a risk of capsule retention. To address this, a medical magnetically driven capsule endoscope with a lubricated soft shell and its preparation method is provided.

[0007] A medical magnetically driven capsule endoscope with a lubricated soft outer shell includes: an inner shell, an endoscope assembly, a water-soluble protective cap, a drug delivery assembly, and a hydrogel shell;

[0008] The inner shell has a sealed cavity and an application cavity arranged along a first direction and isolated from each other;

[0009] The endoscope assembly is located within the sealed cavity, and the endoscope assembly includes a camera module and an illumination module; one end of the inner shell has a first transparent shell wall, which is located at the end of the sealed cavity away from the drug administration cavity; the light-emitting surface of the illumination module and the light-receiving surface of the camera module are respectively opposite to the first transparent shell wall;

[0010] The inner shell has a drug delivery window that communicates with the drug delivery chamber and faces the second direction. The water-soluble protective cover is connected to the inner shell and covers the drug delivery window. The drug delivery assembly is located inside the drug delivery chamber and is used to release the drug to the outside of the inner shell through the drug delivery window. The second direction is perpendicular to the first direction.

[0011] The hydrogel shell covers the inner shell. The hydrogel shell is provided with a drug application opening, a camera opening, and a lighting opening. The drug application opening can expose the water-soluble protective cover. The camera opening is used for the light-receiving surface to collect light. The lighting opening is used for the light emitted by the light-emitting surface to be emitted.

[0012] In one embodiment, the hydrogel shell includes:

[0013] A magnetic layer, which covers the exterior of the inner shell; the magnetic layer is made of calcium alginate hydrogel mixed with iron oxide particles; and,

[0014] A hydrogel layer, which covers the outside of the magnetic layer, is made of calcium alginate hydrogel.

[0015] In one embodiment, a lubricating layer is formed on the outer surface of the hydrogel layer, and the lubricating layer is made of poly(2-methacryloyloxyethylphosphorylcholine).

[0016] In one embodiment, the endoscope assembly further includes a circuit board module, a control module, a radio frequency wireless transmission module, and a power supply module.

[0017] The control module and the radio frequency wireless transmission module are respectively disposed on the circuit board module, and the camera module and the power supply module are respectively electrically connected to the circuit board module;

[0018] The power module is used to supply power to the camera module, the lighting module, the circuit board module, the control module, and the radio frequency wireless transmission module.

[0019] In one embodiment, the circuit board module is located between the camera module and the power module along the first direction;

[0020] The circuit board module includes a first circuit board and a second circuit board stacked along the first direction, with the first circuit board and the second circuit board being electrically connected; the camera module and the lighting module are respectively electrically connected to the first circuit board, and the power supply module is electrically connected to the second circuit board.

[0021] In one embodiment, the drug delivery assembly includes:

[0022] A sliding part, wherein the sliding part is slidably connected to the drug application chamber along the second direction;

[0023] A permanent magnet is fixedly connected to the sliding part; and

[0024] A treatment patch is connected to the end of the sliding part facing out of the drug delivery window, and a drug-loaded microneedle is provided on the side of the treatment patch facing out of the drug delivery window.

[0025] A method for preparing a medical magnetically driven capsule endoscope with a lubricated soft outer shell, used to prepare the medical magnetically driven capsule endoscope as described in any of the above embodiments, the preparation method comprising the following steps:

[0026] The inner housing is provided for mounting the endoscope assembly within the sealed cavity;

[0027] The inner shell is covered with the hydrogel shell, and the drug application opening, the camera opening and the lighting opening are formed on the hydrogel shell;

[0028] The drug application assembly is installed in the drug application chamber, and then the water-soluble protective cover is connected to the inner shell to cover the drug application window.

[0029] In one embodiment, the step of covering the inner housing with the hydrogel shell and forming the drug application opening, the camera opening, and the lighting opening on the hydrogel shell includes:

[0030] The inner housing with the endoscope assembly installed is placed in the first mold. An aqueous suspension containing sodium alginate and iron oxide particles is poured between the inner housing and the first mold. After the aqueous suspension is frozen into a first solid structure, it is demolded from the first mold.

[0031] The first solid structure, which is covered by the inner shell, is placed into the second mold. An aqueous solution containing sodium alginate and a photoinitiator is poured between the first solid structure and the second mold. After the aqueous solution is frozen into the second solid structure, it is demolded from the second mold.

[0032] The structure demolded from the second mold is immersed in a calcium chloride aqueous solution to form a capsule matrix. In this matrix, sodium alginate in the second solid structure undergoes chemical cross-linking with calcium chloride in the calcium chloride aqueous solution to form a calcium alginate hydrogel. Sodium alginate in the first solid structure undergoes chemical cross-linking with calcium chloride in the calcium chloride aqueous solution to form a calcium alginate hydrogel, thereby converting the first solid structure into a calcium alginate hydrogel mixed with iron oxide particles.

[0033] The capsule matrix was immersed in a 2-methacryloxyethylphosphorylcholine solution, and the surface of the capsule matrix was irradiated with an ultraviolet lamp to cause 2-methacryloxyethylphosphorylcholine to polymerize on the outer surface of the calcium alginate hydrogel, forming poly(2-methacryloxyethylphosphorylcholine).

[0034] In one embodiment, the preparation method further includes: after the step of freezing the aqueous solution into a second solid structure and demolding it from the second mold, and before the step of immersing the structure demolded from the second mold in a calcium chloride aqueous solution to form a capsule matrix.

[0035] The structure that has been demolded from the second mold is placed in a temperature environment w for a duration t, wherein w is greater than or equal to 3.5℃ and less than or equal to 4.5℃, and t is greater than or equal to 13 min and less than or equal to 17 min;

[0036] The calcium chloride aqueous solution contains a calcium chloride mass fraction greater than or equal to 2.2% and less than or equal to 2.8%, and the soaking time for the structure that was demolded from the second mold in the calcium chloride aqueous solution is greater than or equal to 18 min and less than or equal to 22 min.

[0037] In one embodiment, in the aqueous suspension containing sodium alginate and iron oxide particles, the mass fraction of sodium alginate is greater than or equal to 9% and less than or equal to 11%, and the mass fraction of iron oxide particles is greater than or equal to 4.5% and less than or equal to 5.5%.

[0038] In the aqueous solution containing sodium alginate and photoinitiator, the mass fraction of sodium alginate is greater than or equal to 9% and less than or equal to 11%, and the mass fraction of photoinitiator is greater than or equal to 0.9% and less than or equal to 1.1%.

[0039] The aforementioned medical magnetically driven capsule endoscope with a lubricated soft outer shell and its preparation method, wherein the endoscope assembly and drug delivery assembly are installed within the inner shell, and a hydrogel outer shell covers the outer shell. The hydrogel outer shell has drug delivery openings, camera openings, and illumination openings, thus meeting the normal operating conditions of the drug delivery assembly, camera module, and illumination module. Furthermore, due to the low friction, high biocompatibility, and softness of the hydrogel, the friction between the hydrogel outer shell and the intestinal wall is minimal during the movement of the medical magnetically driven capsule endoscope within the patient's intestine, reducing the risk of frictional damage to the intestinal wall, improving safety and comfort, and increasing the movement speed of the medical magnetically driven capsule endoscope, thereby improving examination efficiency. Attached Figure Description

[0040] Figure 1 This is a schematic diagram of a medical magnetically driven capsule endoscope according to one embodiment.

[0041] Figure 2 This is a schematic diagram of the internal structure of a medical magnetically driven capsule endoscope according to one embodiment.

[0042] Figure 3 for Figure 2 The front view.

[0043] Figure 4 This is an exploded view of the connection structure between the sliding part and the rear shell according to one embodiment.

[0044] Figure 5 This is a schematic diagram of the connection structure between the sliding part and the permanent magnet in one embodiment.

[0045] Figure 6 This is a flowchart illustrating a method for preparing a medical magnetically driven capsule endoscope according to one embodiment.

[0046] Explanation of reference numerals in the attached figures:

[0047] XX', First direction; YY', Second direction;

[0048] 100. Inner shell; 110. First transparent shell wall; 120. Front shell; 121. End cap; 130. Rear shell; 131. Application window; 132. Guide tube; 133. Stop rod; 134. Stop hook;

[0049] 210. Camera module; 220. Illumination module; 230. Circuit board module; 231. First circuit board; 232. Second circuit board; 240. Power supply module; 250. Radio frequency wireless transmission module;

[0050] 310. Sliding part; 311. Sliding column; 312. Push plate; 314. Anti-disengagement rod; 315. Anti-disengagement hook; 316. Sealing shell; 320. Permanent magnet; 330. Treatment patch;

[0051] 400. Hydrogel shell; 401. Drug application opening; 402. Camera opening; 403. Lighting opening. Detailed Implementation

[0052] To make the above-mentioned objectives, features, and advantages of this application more apparent and understandable, the specific embodiments of this application are described in detail below with reference to the accompanying drawings. Many specific details are set forth in the following description to provide a thorough understanding of this application. However, this application can be implemented in many other ways different from those described herein, and those skilled in the art can make similar modifications without departing from the spirit of this application. Therefore, this application is not limited to the specific embodiments disclosed below.

[0053] In the description of this application, it should be understood that if terms such as "center", "longitudinal", "lateral", "length", "width", "thickness", "upper", "lower", "front", "rear", "left", "right", "vertical", "horizontal", "top", "bottom", "inner", "outer", "clockwise", "counterclockwise", "axial", "radial", "circumferential" appear, these terms indicate the orientation or positional relationship based on the orientation or positional relationship shown in the accompanying drawings, and are only for the convenience of describing this application and simplifying the description, and do not indicate or imply that the device or element referred to must have a specific orientation, or be constructed and operated in a specific orientation, and therefore should not be construed as a limitation of this application.

[0054] Furthermore, where the terms "first" and "second" appear, these terms are for descriptive purposes only and should not be construed as indicating or implying relative importance or implicitly specifying the number of technical features indicated. Thus, a feature defined with "first" or "second" may explicitly or implicitly include at least one of that feature. In the description of this application, where the term "multiple" appears, "multiple" means at least two, such as two, three, etc., unless otherwise explicitly specified.

[0055] In this application, unless otherwise expressly specified and limited, the terms "installation," "connection," "joining," and "fixing," etc., should be interpreted broadly. For example, they can refer to a fixed connection, a detachable connection, or an integral part; they can refer to a mechanical connection or an electrical connection; they can refer to a direct connection or an indirect connection through an intermediate medium; they can refer to the internal communication of two components or the interaction between two components, unless otherwise expressly limited. Those skilled in the art can understand the specific meaning of the above terms in this application based on the specific circumstances.

[0056] In this application, unless otherwise expressly specified and limited, the use of descriptions such as "above" or "below" the second feature indicates that the first and second features are in direct contact or indirect contact via an intermediate medium. Furthermore, "above," "on top of," and "over" the second feature can mean that the first feature is directly above or diagonally above the second feature, or simply that the first feature is at a higher horizontal level than the second feature. Similarly, "below," "below," and "under" the second feature can mean that the first feature is directly below or diagonally below the second feature, or simply that the first feature is at a lower horizontal level than the second feature.

[0057] It should be noted that if an element is referred to as being "fixed to" or "set on" another element, it can be directly on the other element or there may be an intervening element. If an element is considered to be "connected to" another element, it can be directly connected to the other element or there may be an intervening element. If so, the terms "vertical," "horizontal," "upper," "lower," "left," "right," and similar expressions used in this application are for illustrative purposes only and do not represent the only possible implementation.

[0058] Please combine Figure 1 and Figure 2 One embodiment of this application provides a medical magnetically driven capsule endoscope with a lubricated soft outer shell. The medical magnetically driven capsule endoscope includes: an inner shell 100, an endoscope assembly (not labeled), a water-soluble protective cap (not shown in the figure), a drug delivery assembly (not labeled), and a hydrogel shell 400.

[0059] The inner housing 100 has sealed cavities (unlabeled) and drug delivery cavities (unlabeled) arranged and isolated from each other along a first direction XX'. The endoscope assembly is located within the sealed cavity, and the drug delivery assembly is located within the drug delivery cavity. The sealed cavity provides a sealed environment to prevent liquid from entering, thereby ensuring the normal operation of the endoscope assembly.

[0060] like Figure 2 and Figure 3As shown, the endoscope assembly includes a camera module 210 and an illumination module 220. One end of the inner housing 100 has a first transparent shell wall 110, located at the end of the sealed cavity away from the drug administration cavity. The light-emitting surface of the illumination module 220 and the light-receiving surface of the camera module 210 are respectively opposite to the first transparent shell wall 110. The first transparent shell wall 110 is made of a transparent material, allowing light to pass through. Because the light-receiving surface of the camera module 210 is opposite to the first transparent shell wall 110, the camera module 210 can collect light through the first transparent shell wall 110, thereby enabling imaging of the patient's digestive tract. Because the light-emitting surface of the illumination module 220 is opposite to the first transparent shell wall 110, the light emitted by the illumination module 220 can exit through the first transparent shell wall 110, thereby providing illumination for the imaging environment of the camera module 210.

[0061] The inner housing 100 has a drug delivery window 131 communicating with the drug delivery chamber and facing the second direction YY. A water-soluble protective cap is connected to the inner housing 100 and covers the drug delivery window 131. The drug delivery assembly is located inside the drug delivery chamber and is used to release medication to the outside of the inner housing 100 through the drug delivery window 131, wherein the second direction YY' is perpendicular to the first direction XX'. Optionally, the first direction XX' is the axial direction of the medical magnetically driven capsule endoscope of this application. Optionally, the second direction YY' is along the radial direction of the medical magnetically driven capsule endoscope.

[0062] Because the water-soluble protective cap is connected to the inner shell 100 and covers the drug delivery window 131, the water-soluble protective cap prevents the drug delivery component from extending out of the drug delivery window 131 during the movement of the medical magnetically driven capsule endoscope through the patient's digestive tract. The water-soluble protective cap is made of a water-soluble and biocompatible material. Thus, after the medical magnetically driven capsule endoscope reaches the lesion site in the patient's digestive tract, the water-soluble protective cap gradually dissolves in the body fluids within the patient's digestive tract, thereby opening the drug delivery window 131. At this time, the drug delivery component within the drug delivery chamber can release the drug out of the inner shell 100 through the drug delivery window 131, thus delivering the drug to the lesion site within the patient's digestive tract.

[0063] A hydrogel shell 400 covers an inner shell 100. The hydrogel shell 400 has a drug delivery opening 401, a camera opening 402, and an illumination opening 403. The drug delivery opening 401 exposes a water-soluble protective cap. Thus, when the water-soluble protective cap dissolves, the drug delivery opening 401 exposes a drug delivery window 131, allowing the drug delivery component to release medication through the drug delivery window 131 and the drug delivery opening 401 to deliver the medication to the lesion site in the patient's digestive tract.

[0064] The camera opening 402 is used for the light-receiving surface of the camera module 210 to collect light. The illumination opening 403 is used for the light emitted from the light-emitting surface of the illumination module 220 to exit. When the camera module 210 acquires images of the patient's digestive tract, light can pass through the camera opening 402 and the first transparent shell wall 110 into the inner shell 100, thereby enabling the camera module 210 to collect light. At the same time, the light emitted from the light-emitting surface of the illumination module 220 can pass through the first transparent shell wall 110 and the illumination opening 403 to exit, thereby providing an illumination environment for the operation of the camera module 210.

[0065] The aforementioned medical magnetically driven capsule endoscope, encased in a lubricated soft shell, has its endoscope assembly and drug delivery assembly housed within an inner shell 100. A hydrogel shell 400 covers the outer shell of the inner shell 100. The hydrogel shell 400 is provided with a drug delivery opening 401, a camera opening 402, and an illumination opening 403, thus meeting the normal operating conditions of the drug delivery assembly, camera module 210, and illumination module 220. Furthermore, due to the low friction, high biocompatibility, and softness of the hydrogel, the friction between the hydrogel shell 400 and the intestinal wall is minimal during the movement of the medical magnetically driven capsule endoscope within the patient's intestines. This reduces the risk of frictional damage to the intestinal wall, improving safety and comfort, and also increasing the travel speed of the medical magnetically driven capsule endoscope, thereby improving examination efficiency.

[0066] The materials used in water-soluble protective caps include edible gelatin and pharmaceutical-grade hydroxypropyl methylcellulose (HPMC).

[0067] In one embodiment, the hydrogel shell 400 includes a magnetic layer. The magnetic layer covers the exterior of the inner shell 100. The magnetic layer is made of calcium alginate hydrogel mixed with iron oxide particles. When the medical magnetically driven capsule endoscope is inside a patient's digestive tract, an axial magnetic field can be applied to the patient via a magnetic navigation system outside the patient's body. This causes the iron oxide particles in the magnetic layer to experience magnetic force along the magnetic field gradient direction, thereby driving the entire medical magnetically driven capsule endoscope to move within the patient's digestive tract, thus achieving active magnetic actuation of the medical magnetically driven capsule endoscope. Optionally, the iron oxide particles are nanoscale particles. Because the magnetic layer contains iron oxide particles, it is entirely black.

[0068] The specific structure of the magnetic navigation system can be found in existing technologies, and will not be elaborated further here.

[0069] In this embodiment, by incorporating iron oxide particles into calcium alginate hydrogel to form a magnetic layer, the limited space of the capsule endoscope can be fully utilized, resulting in a high degree of integration and a small overall volume. Furthermore, the iron oxide nanoparticles used exhibit superparamagnetism, meaning the direction of the magnetic force they experience changes instantaneously with the gradient of the external magnetic field strength.

[0070] In one embodiment, the hydrogel shell 400 includes a hydrogel layer that covers the outside of the magnetic layer. The hydrogel layer is made of calcium alginate hydrogel. Because the hydrogel layer covers the outside of the magnetic layer, it can encapsulate the magnetite particles in the magnetic layer, thereby minimizing the risk of the magnetite particles falling into the patient's digestive tract.

[0071] In one embodiment, a lubricating layer is formed on the outer surface of the hydrogel layer. The lubricating layer is made of poly(2-methacryloyloxyethylphosphorylcholine) (PMPC), which makes the outer surface of the hydrogel shell 400 more lubricated, thereby further reducing friction when the medical magnetically driven capsule endoscope is inserted into the patient's digestive tract.

[0072] The synthesis of poly(2-methacryloyloxyethylphosphorylcholine) (PMPC) involves polymerizing 2-methacryloyloxyethylphosphorylcholine (MPC) monomers on the outer surface of a calcium alginate hydrogel. Therefore, in this embodiment, the hydrogel layer (calcium alginate hydrogel) coats the outside of the magnetic layer, facilitating the fabrication of a lubricating layer on the outer surface of the hydrogel layer.

[0073] Optionally, the thickness of the lubricating layer is greater than or equal to 0.45 mm, less than or equal to 0.55 mm, and preferably 0.5 mm.

[0074] Please combine Figure 2 and Figure 3 In one embodiment, the inner housing 100 further includes a front housing 120, a rear housing 130, and an end cap 121. A sealing cavity is located within the front housing 120. An application cavity is located within the rear housing 130. The front housing 120 and the rear housing 130 are arranged along a first direction XX'.

[0075] The first transparent shell wall 110 is sealed to one end of the front shell 120. The end of the front shell 120 away from the first transparent shell wall 110 has an installation port for the endoscope assembly to enter, thus facilitating the installation of the endoscope assembly. The end cap 121 is connected to the end of the front shell 120 away from the first transparent shell wall 110 and seals the installation port, thereby creating a sealed environment within the front shell 120's internal cavity to protect the internal endoscope assembly.

[0076] The rear shell 130 is connected to the end cap 121, thereby indirectly connecting to the front shell 120. Since the sealing cavity is located in the front shell 120 and the application cavity is located within the rear shell 130, the sealing cavity and the application cavity can be isolated. An application window 131 is located in the rear shell 130. A water-soluble protective cap is connected to the rear shell 130, thereby covering the application window 131 on the rear shell 130.

[0077] In other embodiments, the inner housing 100 may also not include the end cap 121, that is, the inner housing 100 includes a first transparent shell wall 110, a front shell 120, and a rear shell 130, with the rear shell 130 connected to and sealing the installation port at the end of the front shell 120 away from the first transparent shell wall 110.

[0078] In one embodiment, the front shell 120, rear shell 130, and end cap 121 are all made of transparent material. The material used for the front shell 120, rear shell 130, and end cap 121 is the same as the material used for the first transparent shell wall 110. The front shell 120, first transparent shell wall 110, end cap 121, and rear shell 130 can all be formed by 3D printing.

[0079] Optionally, the front shell 120 and the first transparent shell wall 110 are integrally formed. The end cap 121 and the front shell 120 can be fixed by means of bonding or other methods. The rear shell 130 and the end cap 121 can be fixed by means of bonding or other methods.

[0080] In this application embodiment, the transparent material is preferably a transparent biocompatible material. Examples of transparent biocompatible materials include transparent resins and PC (polycarbonate).

[0081] In other embodiments, the front shell 120, end cap 121, and rear shell 130 may also be made of non-transparent materials. The first transparent shell wall 110 may be made of transparent material.

[0082] Please refer to Figure 2 and Figure 3 In one embodiment, the endoscope assembly further includes a circuit board module 230, a control module, a radio frequency wireless transmission module 250, and a power supply module 240.

[0083] The control module (unlabeled) and the radio frequency wireless transmission module 250 are respectively mounted on the circuit board module 230. The camera module 210 and the power supply module 240 are electrically connected to the circuit board module 230. The lighting module 220 can be mounted on the circuit board of the camera module 210.

[0084] The power module 240 is used to supply power to the camera module 210, the lighting module 220, the circuit board module 230, the control module, and the radio frequency wireless transmission module 250. Since the power module 240 is electrically connected to the circuit board module 230, the power module 240 can supply power to the various functional modules connected to the circuit board module 230.

[0085] The host computer located outside the patient's body can transmit signals to the control module via the radio frequency wireless transmission module 250. Specifically, the host computer can send control signals to the control module via the radio frequency wireless transmission module 250, and the control module can control the operation of the camera module 210 and the lighting module 220 according to the control signals. The images captured by the camera module 210 can be transmitted to the control module, and the control module can feed the images back to the host computer via the radio frequency wireless transmission module 250.

[0086] The specific structure and detailed working principle of the camera module 210, lighting module 220 (such as LED light), circuit board module 230, control module (such as MCU system), power supply module 240 (such as button battery), and radio frequency wireless transmission module 250 can be referred to the existing technology, and will not be elaborated here.

[0087] Optionally, the camera module 210 and the circuit board module 230 are electrically connected via a board-to-board connector. The power supply module 240 and the circuit board module 230 can be electrically connected via wires.

[0088] Please refer to Figure 2 and Figure 3 In one embodiment, the circuit board module 230 is located between the camera module 210 and the power module 240 along a first direction XX'. The circuit board module 230 includes a first circuit board 231 and a second circuit board 232 stacked along the first direction XX', and the first circuit board 231 and the second circuit board 232 are electrically connected. The camera module 210 is electrically connected to the first circuit board 231. The power module 240 is electrically connected to the second circuit board 232.

[0089] This embodiment facilitates the electrical connection of the camera module 210 and the power module 240 to the circuit board module 230, and the various functional modules of the endoscope assembly are arranged in a compact manner.

[0090] Optionally, both the first circuit board 231 and the second circuit board 232 are double-sided circuit boards. The opposite sides of the first circuit board 231 and the second circuit board 232 are connected by wires. The camera module 210 is electrically connected to the side of the first circuit board 231 that is away from the second circuit board 232. The power module 240 is electrically connected to the side of the second circuit board 232 that is away from the first circuit board 231.

[0091] The first circuit board 231 and the second circuit board 232 can be rigid-flex boards or FPC circuit boards.

[0092] Please combine Figure 2 , Figure 4 , Figure 5In one embodiment, the drug delivery assembly includes a sliding portion 310, a permanent magnet 320, and a treatment patch 330. The sliding portion 310 is slidably connected to the drug delivery cavity along the second direction YY'. The permanent magnet 320 is fixedly connected to the sliding portion 310. The treatment patch 330 is connected to the end of the sliding portion 310 facing outwards from the drug delivery window 131, and a drug-loaded microneedle (not shown in the figure) is disposed on the side of the treatment patch 330 facing outwards from the drug delivery window 131.

[0093] Since the sliding part 310 is slidably connected to the drug application cavity along the second direction YY', the sliding part 310 can move along the second direction YY' to the inside or outside of the drug application cavity, thereby driving the treatment patch 330 and the drug-loaded microneedle to move along the second direction YY'.

[0094] After the medical magnetically driven capsule endoscope reaches the lesion site in the patient's digestive tract and the water-soluble protective cap dissolves, the drug delivery window 131 opens. At this time, a magnetic field along the second direction YY' can be applied to the patient from outside the body, causing the permanent magnet 320 to be driven by a magnetic force along the second direction YY', thereby driving the permanent magnet 320 to move along the second direction YY'. In this way, the permanent magnet 320 can drive the sliding part 310 fixedly connected to it to move along the second direction YY'. When the sliding part 310 moves along the second direction YY', it can drive the treatment patch 330 and the drug-loaded microneedle to move along the second direction YY', thereby allowing the drug-loaded microneedle to be inserted into the lesion site in the patient's digestive tract.

[0095] In other embodiments, the drug delivery assembly may also adopt other structural forms in the prior art, such as a spring-driven drug delivery assembly.

[0096] Please combine Figure 4 and Figure 5 In one embodiment, the sliding part 310 includes a sliding post 311 and a push plate 312. The push plate 312 is fixedly connected to one end of the sliding post 311. The treatment patch 330 is disposed on the side of the push plate 312 opposite to the sliding post 311. One end of the permanent magnet 320 is fixedly connected to the push plate 312. A guide cylinder 132 is provided at the bottom of the drug application chamber. The sliding post 311 and the guide cylinder 132 slide in a second direction YY', thereby limiting the movement direction of the sliding post 311, and thus limiting the overall movement direction of the sliding part 310.

[0097] Please combine Figure 4 and Figure 5In one embodiment, a stop rod 133 is provided at the bottom of the application chamber, and a stop hook 134 is provided at one end of the stop rod 133 away from the bottom of the application chamber. The sliding part 310 includes an anti-detachment rod 314, one end of which is fixedly connected to the push plate 312, and the other end of which has an anti-detachment hook 315. The stop hook 134 is located on the side of the anti-detachment hook 315 close to the push plate 312 along the second direction YY'. Thus, as the sliding part 310 moves out of the application chamber along the second direction YY', when the stop hook 134 hooks the anti-detachment hook 315, it can prevent the anti-detachment hook 315 from continuing to move out of the application chamber, thereby preventing the sliding part 310 from detaching from the application chamber.

[0098] Please combine Figure 4 and Figure 5 In one embodiment, the anti-detachment rod 314 is provided with a slot 3141. The sliding part 310 also includes a sealing shell 316, on which a locking block 3161 is provided. The locking block 3161 cooperates with the slot 3141 to fix the sealing shell 316 and the anti-detachment rod 314.

[0099] A sealing shell 316 surrounds the permanent magnet 320, the sliding column 311, and the anti-dislodgement rod 314. The sealing shell 316 is in a sealing fit with the wall of the drug delivery chamber, and the sealing shell 316 can move relative to the wall of the drug delivery chamber in the second direction YY'. The push plate 312 closes the end of the sealing shell 316 away from the bottom of the drug delivery chamber. In this way, substances in the patient's digestive tract can be prevented from entering the space enclosed by the push plate 312 and the sealing shell 316, thereby protecting the permanent magnet 320 and other components inside the drug delivery assembly.

[0100] Please refer to Figure 6 This application provides a method for preparing a medical magnetically driven capsule endoscope with a lubricated soft outer shell, used to prepare the medical magnetically driven capsule endoscope of any of the above embodiments. The preparation method includes the following steps:

[0101] S100: Provides an inner housing 100 for mounting the endoscope assembly within a sealed cavity.

[0102] S200: The inner shell 100 is covered with a hydrogel shell 400, and the hydrogel shell 400 is formed with a drug application opening 401, a camera opening 402 and an illumination opening 403.

[0103] S300: Install the drug delivery component inside the drug delivery chamber, and then connect the water-soluble protective cover to the inner shell to cover the drug delivery window 131. This step involves installing the drug delivery component and the water-soluble protective cover after the hydrogel shell 400 has been prepared. This avoids the influence of the preparation environment on the drug delivery component and the water-soluble protective cover during the preparation of the hydrogel shell 400, thus facilitating the preparation of the hydrogel shell 400.

[0104] The above-described method for preparing a medical magnetically driven capsule endoscope with a lubricated soft outer shell involves installing the endoscope assembly and the drug delivery assembly within the inner shell 100. A hydrogel shell 400 is then wrapped around the inner shell 100, forming a drug delivery opening 401, a camera opening 402, and an illumination opening 403 on the hydrogel shell 400. This ensures the normal operation of the drug delivery assembly, camera module 210, and illumination module 220. Furthermore, due to the low friction, high biocompatibility, and softness of the hydrogel, the friction between the hydrogel shell 400 and the intestinal wall is minimized during the movement of the medical magnetically driven capsule endoscope through the patient's intestines. This reduces the risk of frictional damage to the intestinal wall, improving safety and comfort. Additionally, it increases the movement speed of the medical magnetically driven capsule endoscope, thereby improving examination efficiency.

[0105] In one embodiment, step S200 includes:

[0106] S210: Place the inner housing 100 with the endoscope assembly installed in the first mold, pour an aqueous suspension containing sodium alginate and iron oxide particles between the inner housing 100 and the first mold, freeze the aqueous suspension in the first mold into a first solid structure, and then demold it from the first mold.

[0107] An aqueous suspension containing sodium alginate and iron oxide particles is used to fabricate the magnetic layer of the hydrogel shell 400. The shape of the cavity defined between the inner wall of the first mold and the outer surface of the inner shell 100 is adapted to the shape of the magnetic layer. The structure after demolding from the first mold includes: a first solid structure, an inner shell 100 enclosed within a first fixed structure, and an endoscope assembly installed within the inner shell 100.

[0108] A magnetic layer is prepared by pouring an aqueous suspension containing sodium alginate and iron oxide particles into a first mold. The resulting magnetic layer can fully fill all the gaps on the surface of the inner shell 100, thereby improving space utilization and ensuring that the overall volume of the capsule endoscope is small. At the same time, it saves space so that more other functional modules can be installed inside the capsule endoscope.

[0109] S220: The first solid structure, which is covered with the inner shell 100, is placed into the second mold. An aqueous solution containing sodium alginate and photoinitiator is poured between the first solid structure and the second mold. After the aqueous solution in the second mold is frozen into the second solid structure, it is demolded from the second mold.

[0110] An aqueous solution containing sodium alginate and a photoinitiator is used to fabricate the hydrogel layer of the hydrogel shell 400. The cavity shape defined between the inner wall of the second mold and the outer surface of the first solid structure is adapted to the shape of the hydrogel layer.

[0111] S230: The structure to be demolded from the second mold is immersed in an aqueous solution of calcium chloride to form a capsule matrix; wherein, sodium alginate in the second solid structure undergoes chemical cross-linking with calcium chloride in the aqueous solution of calcium chloride to form calcium alginate hydrogel, and sodium alginate in the first solid structure undergoes chemical cross-linking with calcium chloride in the aqueous solution of calcium chloride to form calcium alginate hydrogel, so that the first solid structure is converted into a calcium alginate hydrogel mixed with iron oxide particles.

[0112] The structure after demolding from the second mold includes: a second solid structure, a first solid structure enclosed within the second solid structure, an inner housing 100 enclosed within the first fixed structure, and an endoscope assembly installed within the inner housing 100.

[0113] In this step, during the process of immersing the structure demolded from the second mold in a calcium chloride aqueous solution, the sodium alginate in the second solid structure undergoes chemical cross-linking with the calcium chloride in the calcium chloride aqueous solution to form a calcium alginate hydrogel, thereby forming a hydrogel layer; the sodium alginate in the first solid structure undergoes chemical cross-linking with the calcium chloride in the calcium chloride aqueous solution to form a calcium alginate hydrogel, thus transforming the first solid structure into a calcium alginate hydrogel mixed with iron oxide particles, thereby forming a magnetic layer. Thus, the capsule matrix is ​​obtained. Understandably, the capsule matrix includes an inner shell 100, an endoscope assembly, a magnetic layer, and a hydrogel layer.

[0114] S240: The capsule matrix is ​​immersed in a 2-methacryloxyethylphosphorylcholine solution, and the surface of the capsule matrix is ​​irradiated with ultraviolet light to cause 2-methacryloxyethylphosphorylcholine to polymerize on the outer surface of the calcium alginate hydrogel to form poly(2-methacryloxyethylphosphorylcholine).

[0115] In this step, while the capsule matrix is ​​immersed in a 2-methacryloxyethylphosphorylcholine solution, the hydrogel layer (i.e., calcium alginate hydrogel) is in the 2-methacryloxyethylphosphorylcholine solution environment. Simultaneously, the surface of the capsule matrix is ​​irradiated with ultraviolet light, causing the photoinitiator in the hydrogel layer to initiate the polymerization of 2-methacryloxyethylphosphorylcholine, thereby forming a polymer (2-methacryloxyethylphosphorylcholine) on the surface of the hydrogel layer. The photoinitiator type is, for example, I2989 photoinitiator. Therefore, the lubricating layer is formed by the polymerization of 2-methacryloxyethylphosphorylcholine on the surface of the calcium alginate hydrogel.

[0116] In one embodiment, the above preparation method further includes: after step S220 and before step S230, placing the structure demolded from the second mold in a temperature environment of w for a duration of t, wherein w is greater than or equal to 3.5°C and less than or equal to 4.5°C, and t is greater than or equal to 13 min and less than or equal to 17 min.

[0117] Through experimental research, the inventors discovered that after step S220, placing the structure demolded from the second mold in a temperature environment w for a duration t allows both the first and second solid structures to be in a state of near melting but not yet fully melted. Thus, when step S230 is performed, the resulting calcium alginate hydrogel, formed by the chemical cross-linking of sodium alginate and calcium chloride, exhibits superior texture and properties. Preferably, w is 4°C and t is 15 min.

[0118] In one embodiment, the mass fraction of calcium chloride in the calcium chloride aqueous solution is greater than or equal to 2.2% and less than or equal to 2.8%, and the soaking time of the structure demolded from the second mold in the calcium chloride aqueous solution is greater than or equal to 18 min and less than or equal to 22 min. Optionally, the mass fraction of calcium chloride is 2.5%.

[0119] In one embodiment, in the aqueous suspension containing sodium alginate and iron oxide particles, the mass fraction of sodium alginate is greater than or equal to 9% and less than or equal to 11%, and the mass fraction of iron oxide particles is greater than or equal to 4.5% and less than or equal to 5.5%. Optionally, in the aqueous suspension containing sodium alginate and iron oxide particles, the mass fraction of sodium alginate is 10%, and the mass fraction of iron oxide particles is 5%.

[0120] In one embodiment, in the aqueous solution containing sodium alginate and a photoinitiator, the mass fraction of sodium alginate is greater than or equal to 9% and less than or equal to 11%, and the mass fraction of the photoinitiator is greater than or equal to 0.9% and less than or equal to 1.1%. Optionally, in the aqueous solution containing sodium alginate and a photoinitiator, the mass fraction of sodium alginate is 10%, and the mass fraction of the photoinitiator is 1%.

[0121] In one embodiment, in step S240, the mass fraction of 2-methacryloxyethylphosphorylcholine in the 2-methacryloxyethylphosphorylcholine solution is greater than or equal to 9% and less than or equal to 11%, preferably 10%. The irradiation time of the capsule matrix by the ultraviolet lamp is greater than or equal to 110 min and less than or equal to 130 min. Preferably, the irradiation time of the capsule matrix by the ultraviolet lamp is 120 min.

[0122] The technical features of the above embodiments can be combined in any way. For the sake of brevity, not all possible combinations of the technical features in the above embodiments are described. However, as long as there is no contradiction in the combination of these technical features, they should be considered to be within the scope of this specification.

[0123] The embodiments described above are merely illustrative of several implementation methods of this application, and while the descriptions are relatively specific and detailed, they should not be construed as limiting the scope of the patent application. It should be noted that those skilled in the art can make various modifications and improvements without departing from the concept of this application, and these all fall within the protection scope of this application. Therefore, the protection scope of this patent application should be determined by the appended claims.

Claims

1. A medical magnetic drive capsule endoscope coated with a lubricating soft shell, characterized in that, The medical magnetic driving capsule endoscope comprises an inner shell, an endoscope assembly, a water-soluble protective cover, a drug delivery assembly and a hydrogel shell. The inner shell has a sealed cavity and a drug delivery cavity arranged along a first direction and isolated from each other. The endoscope assembly is located in the sealed cavity, and the endoscope assembly comprises a camera module and an illumination module; one end of the inner shell has a first transparent shell wall, and the first transparent shell wall is located at one end of the sealed cavity away from the drug delivery cavity; the light emitting surface of the illumination module and the light receiving surface of the camera module are respectively opposite to the first transparent shell wall; The inner shell is provided with a drug delivery window which is communicated with the drug delivery cavity and faces a second direction, the water-soluble protective cover is connected with the inner shell and covers the drug delivery window; the drug delivery assembly is located in the drug delivery cavity, and the drug delivery assembly is used to release drugs outside the inner shell through the drug delivery window, and the second direction is perpendicular to the first direction; The hydrogel shell covers the inner shell, and the hydrogel shell is provided with a drug delivery opening, a camera opening and an illumination opening; the drug delivery opening can expose the water-soluble protective cover; the camera opening is used for the light receiving surface to collect light; and the illumination opening is used for the light emitted by the light emitting surface to be emitted. The hydrogel shell comprises: A magnetic layer, which covers the outside of the inner shell; the material of the magnetic layer is calcium alginate hydrogel mixed with ferroferric oxide particles; and A hydrogel layer, which covers the outside of the magnetic layer, and the material of the hydrogel layer is calcium alginate hydrogel; The outer surface of the hydrogel layer is formed with a lubricating layer, and the material of the lubricating layer is poly(2-methacryloyloxyethyl phosphorylcholine). The endoscope assembly further comprises a circuit board module, a control module, a radio frequency wireless transmission module and a power supply module, 2. The magnetically driven medical capsule endoscope according to claim 1, wherein The control module and the radio frequency wireless transmission module are respectively arranged on the circuit board module, and the camera module and the power supply module are respectively electrically connected with the circuit board module; The power supply module is used to supply power for the camera module, the illumination module, the circuit board module, the control module and the radio frequency wireless transmission module.

3. The medical magnetic driving capsule endoscope according to claim 2, wherein The circuit board module is located between the camera module and the power supply module along the first direction; The circuit board module comprises a first circuit board and a second circuit board which are arranged in a stacked manner along the first direction, and the first circuit board is electrically connected with the second circuit board; the camera module and the illumination module are respectively electrically connected with the first circuit board, and the power supply module is electrically connected with the second circuit board. The drug delivery assembly comprises:

4. The magnetically propelled medical capsule endoscope according to claim 1, wherein A sliding part which is connected with the drug delivery cavity in a sliding manner along the second direction; A permanent magnet which is fixedly connected with the sliding part; and A treatment patch which is connected with one end of the sliding part away from the drug delivery window, and one side of the treatment patch away from the drug delivery window is provided with a drug-loaded microneedle. A preparation method for the medical magnetic driving capsule endoscope according to any one of claims 1-4, the preparation method comprising the following steps:

5. A method of manufacturing a medical magnetic drive capsule endoscope coated with a lubricating soft shell, characterized by, ​ The inner shell is provided, and the endoscope assembly is installed in the sealed cavity; The hydrogel shell is coated outside the inner shell, and the drug administration opening, the camera opening and the illumination opening are formed on the hydrogel shell; The drug administration assembly is installed in the drug administration cavity, and the water-soluble protective cover is connected with the inner shell to cover the drug administration window.

6. The production method according to claim 5, wherein The step of coating the hydrogel shell outside the inner shell and forming the drug administration opening, the camera opening and the illumination opening on the hydrogel shell comprises: The inner shell with the endoscope assembly installed is placed in a first mold, a water suspension mixed with sodium alginate and ferroferric oxide particles is poured between the inner shell and the first mold, the water suspension is frozen into a first solid structure, and then the first mold is demolded; The first solid structure coated with the inner shell is placed in a second mold, a water solution mixed with sodium alginate and a photoinitiator is poured between the first solid structure and the second mold, the water solution is frozen into a second solid structure, and then the second mold is demolded; The structure demolded from the second mold is soaked in a calcium chloride aqueous solution to form a capsule matrix, wherein the sodium alginate in the second solid structure and the calcium chloride in the calcium chloride aqueous solution are chemically cross-linked to form calcium alginate hydrogel, and the sodium alginate in the first solid structure and the calcium chloride in the calcium chloride aqueous solution are chemically cross-linked to form calcium alginate hydrogel, so that the first solid structure is converted into calcium alginate hydrogel mixed with ferroferric oxide particles; The capsule matrix is soaked in a 2-methacryloyloxyethyl phosphorylcholine solution, and the surface of the capsule matrix is irradiated by a UV lamp, so that 2-methacryloyloxyethyl phosphorylcholine is polymerized on the outer surface of the calcium alginate hydrogel to form poly(2-methacryloyloxyethyl phosphorylcholine).

7. The preparation method according to claim 6, characterized in that, The preparation method further comprises, after the step of freezing the water solution into a second solid structure and demolding the second mold, and before the step of soaking the structure demolded from the second mold in a calcium chloride aqueous solution to form a capsule matrix, The structure demolded from the second mold is placed in a w temperature environment for t length of time, wherein w is greater than or equal to 3.5℃ and less than or equal to 4.5℃, and t is greater than or equal to 13min and less than or equal to 17min; The mass fraction of calcium chloride in the calcium chloride aqueous solution is greater than or equal to 2.2% and less than or equal to 2.8%, the soaking time of the structure demolded from the second mold in the calcium chloride aqueous solution is greater than or equal to 18min and less than or equal to 22min.

8. The preparation method according to claim 6, wherein In the water suspension mixed with sodium alginate and ferroferric oxide particles, the mass fraction of sodium alginate is greater than or equal to 9% and less than or equal to 11%, and the mass fraction of ferroferric oxide particles is greater than or equal to 4.5% and less than or equal to 5.5%. The mass fraction of sodium alginate in the mixed aqueous solution of sodium alginate and the photoinitiator is greater than or equal to 9% and less than or equal to 11%, and the mass fraction of the photoinitiator is greater than or equal to 0.9% and less than or equal to 1.1%. The mass fraction of sodium alginate in the mixed aqueous solution of sodium alginate and the photoinitiator is greater than or equal to 9% and less than or equal to 11%, and the mass fraction of the photoinitiator is greater than or equal to 0.9% and less than or equal to

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