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

Abstract

The invention relates to a medical magnetic drive capsule endoscope coated with a lubricating soft shell and a preparation method of the medical magnetic drive capsule endoscope. The medical magnetically-driven 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 is provided with a sealing cavity and a pesticide applying cavity; the endoscope assembly is located in the sealing cavity and comprises a camera module and an illumination module. The inner shell is provided with a pesticide application window which is communicated with the pesticide application cavity and faces the second direction, and the water-soluble protective cover is connected with the inner shell and covers the pesticide application window; the pesticide applying assembly is located in the pesticide applying cavity; the hydrogel shell covers the inner shell, and the hydrogel shell is provided with a medicine applying opening, a camera shooting opening and a lighting opening. According to the medical magnetic drive capsule endoscope, when the medical magnetic drive capsule endoscope advances in the intestinal tract of a patient, friction between the hydrogel shell and the intestinal wall is small, the intestinal wall is not prone to being damaged by friction, safety and comfort are improved, the advancing speed of the medical magnetic drive capsule endoscope can be increased, and examination efficiency is improved.

Description

Technical Field

[0001] The present application relates to the technical field of medical devices, and in particular to a medical magnetically driven capsule endoscope coated with a lubricating soft shell and a preparation method thereof. Background Art

[0002] Capsule endoscope is an emerging medical device specially used for the inspection and diagnosis of the digestive tract. The capsule endoscope places the camera module, wireless transmission module and power module in a capsule that can be swallowed orally, so that the capsule endoscope can perform a comprehensive inspection in the patient's digestive tract.

[0003] Compared with traditional endoscopes, capsule endoscopes provide a non-invasive, convenient and comfortable inspection method, which reduces the discomfort and risks caused by traditional inspections to a certain extent. Capsule endoscopes can take high-quality images while passing through the digestive tract and transmit them to an external receiving device through a wireless transmission module, allowing doctors to comprehensively inspect the entire digestive tract including the esophagus, stomach, small intestine and large intestine, especially the small intestine that is difficult to reach with traditional endoscopes.

[0004] The movement of common capsule endoscopes in the intestines usually relies on the natural peristalsis of the intestines. The intestinal environment of different patients is different, and the passive random movement of the intestines will greatly affect the stability of the image taken, thereby increasing the occurrence of missed detections and possible capsule retention. To solve the above problems, researchers have developed a variety of active movement methods for capsule endoscopes, among which the magnetic drive method has become an ideal solution due to its high integration and high space utilization.

[0005] In the related art, when a magnetically driven capsule endoscope moves in the patient's intestine, it will inevitably be dragged by the magnetic force. The friction between the capsule shell and the intestinal wall is large, which can easily cause friction damage to the intestinal wall and also reduce the moving speed of the magnetically driven capsule endoscope. Summary of the invention

[0006] Based on this, it is necessary to provide a medical magnetically driven capsule endoscope coated with a lubricating soft shell and a preparation method thereof, in order to address the technical problem that a magnetically driven capsule endoscope will inevitably be dragged by the magnetic force while moving in the patient's intestine, and the friction between the capsule shell and the intestinal wall is large, which can easily cause friction damage to the intestinal wall and reduce the moving speed of the magnetically driven capsule endoscope, thereby posing a risk of capsule retention.

[0007] A medical magnetically driven capsule endoscope covered with a lubricating soft shell comprises: an inner shell, an endoscope component, a water-soluble protective cover, a drug application component and a hydrogel shell;

[0008] The inner shell has a sealing cavity and a drug application cavity which are arranged along a first direction and isolated from each other;

[0009] The endoscope assembly is located in the sealed cavity, and the endoscope assembly includes a camera module and a lighting module; one end of the inner shell has a first transparent shell wall, and the first transparent shell wall is located at an end of the sealed cavity away from the medication cavity; the light-emitting surface of the lighting module and the light-collecting surface of the camera module are respectively opposite to the first transparent shell wall;

[0010] The inner shell is provided with a drug dispensing window which is in communication with the drug dispensing cavity and faces a second direction, the water-soluble protective cover is connected to the inner shell and covers the drug dispensing window; the drug dispensing assembly is located in the drug dispensing cavity, and the drug dispensing assembly is used to release the drug to the outside of the inner shell through the drug dispensing window, and the second direction is perpendicular to the first direction;

[0011] The hydrogel shell is coated on the outside of the inner shell, and is provided with a drug application opening, a camera opening and a lighting opening. The drug application opening can reveal the water-soluble protective cover, the camera opening is used for the lighting surface to collect light, and the lighting opening is used for the light emitted by the light-emitting surface to emit.

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

[0013] A magnetic layer, the magnetic layer is coated on the outside of the inner shell; the material of the magnetic layer is calcium alginate hydrogel mixed with ferroferric oxide particles; and,

[0014] A hydrogel layer is coated on the outside of the magnetic layer, and the material of the hydrogel layer is calcium alginate hydrogel.

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

[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 module.

[0017] 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 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, the first circuit board is electrically connected to the second circuit board; the camera module and the lighting module are electrically connected to the first circuit board respectively, and the power module is electrically connected to the second circuit board.

[0021] In one embodiment, the drug dispensing assembly comprises:

[0022] A sliding portion, wherein the sliding portion is slidably connected to the medication cavity along the second direction;

[0023] a permanent magnet fixedly connected to the sliding portion; and

[0024] The treatment patch is connected to one end of the sliding part facing the outside of the drug application window, and the side of the treatment patch facing the outside of the drug application window is provided with drug-carrying microneedles.

[0025] A method for preparing a medical magnetically driven capsule endoscope coated with a lubricating soft shell, which is used to prepare the medical magnetically driven capsule endoscope described in any one of the above embodiments, and the preparation method comprises the following steps:

[0026] providing the inner housing, and installing the endoscope assembly in the sealed cavity;

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

[0028] The medicine dispensing assembly is installed in the medicine dispensing cavity, and then the water-soluble protective cover is connected to the inner shell to cover the medicine dispensing window.

[0029] In one embodiment, the step of covering the hydrogel shell on the outside of the inner shell and forming the drug dispensing opening, the camera opening and the lighting opening on the hydrogel shell comprises:

[0030] The inner housing with the endoscope assembly installed therein is placed in a first mold, a water suspension mixed with sodium alginate and ferroferric oxide particles is poured between the inner housing and the first mold, the water suspension is frozen into a first solid structure, and then demolded from the first mold;

[0031] placing the first solid structure covered with the inner shell into a second mold, pouring an aqueous solution mixed with sodium alginate and a photoinitiator between the first solid structure and the second mold, freezing the aqueous solution into a second solid structure, and demolding from the second mold;

[0032] The structure demoulded from the second mold is immersed in a calcium chloride aqueous solution to form a capsule matrix, wherein the sodium alginate in the second solid structure is chemically cross-linked with the calcium chloride in the calcium chloride aqueous solution to form a calcium alginate hydrogel, and the sodium alginate in the first solid structure is chemically cross-linked with the calcium chloride in the calcium chloride aqueous solution to form a calcium alginate hydrogel, so that the first solid structure is converted into a calcium alginate hydrogel mixed with ferrosoferric oxide particles;

[0033] The capsule matrix is ​​immersed in a 2-methacryloyloxyethyl phosphorylcholine solution, and the surface of the capsule matrix is ​​irradiated with an ultraviolet lamp, so that the 2-methacryloyloxyethyl phosphorylcholine is polymerized on the outer surface of the calcium alginate hydrogel to form poly (2-methacryloyloxyethyl phosphorylcholine).

[0034] In one embodiment, the preparation method further comprises: after the step of freezing the aqueous solution into a second solid structure and demolding the aqueous solution 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] placing the structure demoulded from the second mold in a temperature environment of w for a time 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;

[0036] 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 structure demoulded from the second mold is immersed in the calcium chloride aqueous solution for a time period greater than and equal to 18 minutes and less than and equal to 22 minutes.

[0037] In one embodiment, in the aqueous 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%;

[0038] In the aqueous solution mixed with 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%.

[0039] In the above-mentioned medical magnetically driven capsule endoscope coated with a lubricating soft shell and the preparation method thereof, the endoscope assembly and the drug dispensing assembly are installed in the inner shell. The hydrogel shell is coated on the outside of the inner shell. The hydrogel shell is provided with a drug dispensing opening, a camera opening and a lighting opening, so that the normal working conditions of the drug dispensing assembly, the camera module and the lighting module can be met. On this basis, since the hydrogel has the characteristics of low friction, high biocompatibility and softness, the friction between the hydrogel shell and the intestinal wall is small during the movement of the medical magnetically driven capsule endoscope in the patient's intestine, and the intestinal wall is not easily damaged by friction, thereby improving safety and comfort, and being able to increase the travel speed of the medical magnetically driven capsule endoscope and improve inspection efficiency. BRIEF DESCRIPTION OF THE DRAWINGS

[0040] Figure 1 Schematic diagram of a medical magnetically driven capsule endoscope according to an embodiment.

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

[0042] Figure 3 for Figure 2 Front view of .

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

[0044] Figure 5 The figure is a schematic diagram of the connection structure between the sliding part and the permanent magnet according to one embodiment.

[0045] Figure 6 The present invention is a flow chart of a method for preparing a medical magnetically driven capsule endoscope according to an embodiment.

[0046] Description of reference numerals:

[0047] XX', first direction; YY', second direction;

[0048] 100, inner shell; 110, first transparent shell wall; 120, front shell; 121, end cover; 130, rear shell; 131, spraying window; 132, guide cylinder; 133, stop rod; 134, stop hook;

[0049] 210, camera module; 220, lighting module; 230, circuit board module; 231, first circuit board; 232, second circuit board; 240, power module; 250, radio frequency wireless transmission module;

[0050] 310, sliding part; 311, sliding column; 312, push plate; 314, anti-drop rod; 315, anti-drop hook; 316, sealing shell; 320, permanent magnet; 330, therapeutic patch;

[0051] 400, hydrogel shell; 401, drug administration opening; 402, camera opening; 403, lighting opening. DETAILED DESCRIPTION

[0052] In order to make the above-mentioned purposes, features and advantages of the present application more obvious and easy to understand, the specific implementation methods of the present application are described in detail below in conjunction with the accompanying drawings. In the following description, many specific details are set forth to facilitate a full understanding of the present application. However, the present application can be implemented in many other ways different from those described herein, and those skilled in the art can make similar improvements without violating the connotation of the present application, so the present application is not limited by the specific embodiments disclosed below.

[0053] In the description of the present application, it should be understood that if the terms "center", "longitudinal", "lateral", "length", "width", "thickness", "up", "down", "front", "back", "left", "right", "vertical", "horizontal", "top", "bottom", "inside", "outside", "clockwise", "counterclockwise", "axial", "radial", "circumferential", etc. appear, the orientation or position relationship indicated by these terms is based on the orientation or position relationship shown in the accompanying drawings, which is only for the convenience of describing the present application and simplifying the description, and does not indicate or imply that the device or element referred to must have a specific orientation, be constructed and operated in a specific orientation, and therefore cannot be understood as a limitation on the present application.

[0054] In addition, if the terms "first" or "second" appear, these terms are used for descriptive purposes only and should not be understood as indicating or implying relative importance or implicitly indicating the number of technical features indicated. Therefore, a feature defined as "first" or "second" may explicitly or implicitly include at least one of the features. In the description of this application, if the term "plurality" appears, the meaning of "plurality" is at least two, such as two, three, etc., unless otherwise clearly and specifically defined.

[0055] In this application, unless otherwise clearly specified and limited, if the terms "installed", "connected", "connected", "fixed" and the like appear, these terms should be understood in a broad sense. For example, it can be a fixed connection, a detachable connection, or an integrated connection; it can be a mechanical connection or an electrical connection; it can be a direct connection or an indirect connection through an intermediate medium, it can be the internal connection of two elements or the interaction relationship between two elements, unless otherwise clearly defined. For ordinary technicians in this field, the specific meanings of the above terms in this application can be understood according to the specific circumstances.

[0056] In the present application, unless otherwise clearly specified and limited, if there is a description that a first feature is "above" or "below" a second feature, etc., or similar descriptions appear, it may mean that the first and second features are in direct contact, or that the first and second features are in indirect contact through an intermediate medium. Moreover, the first feature being "above", "above" and "above" the second feature may mean that the first feature is directly above or obliquely above the second feature, or simply means that the first feature is higher in level than the second feature. The first feature being "below", "below" and "below" the second feature may mean that the first feature is directly below or obliquely below the second feature, or simply means that the first feature is lower in level than the second feature.

[0057] It should be noted that if an element is referred to as being "fixed to" or "disposed on" another element, it may be directly on the other element or there may be a central element. If an element is considered to be "connected to" another element, it may be directly connected to the other element or there may be a central element at the same time. If any, 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 implementation method.

[0058] Please combine Figure 1 and Figure 2 An embodiment of the present application provides a medical magnetically driven capsule endoscope covered with a lubricating soft shell. The medical magnetically driven capsule endoscope comprises: an inner shell 100, an endoscope component (not numbered), a water-soluble protective cover (not shown in the figure), a drug application component (not numbered) and a hydrogel shell 400.

[0059] The inner housing 100 has a sealed cavity (not numbered) and a drug dispensing cavity (not numbered) arranged along the first direction XX' and isolated from each other. The endoscope assembly is located in the sealed cavity, and the drug dispensing assembly is located in the drug dispensing cavity. The sealed cavity is 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 a lighting module 220. One end of the inner shell 100 has a first transparent shell wall 110, and the first transparent shell wall 110 is located at one end of the sealed cavity away from the medication cavity. The light-emitting surface of the lighting module 220 and the light-collecting 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 so that light can pass through. Since the light-collecting 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, and then the patient's digestive tract can be photographed. Since the light-emitting surface of the lighting module 220 is opposite to the first transparent shell wall 110, the light emitted by the lighting module 220 can be emitted through the first transparent shell wall 110, and then the shooting environment of the camera module 210 can be provided with lighting.

[0061] The inner shell 100 is provided with a drug dispensing window 131 which is connected to the drug dispensing cavity and faces the second direction YY. The water-soluble protective cover is connected to the inner shell 100 and covers the drug dispensing window 131. The drug dispensing assembly is located in the drug dispensing cavity, and the drug dispensing assembly is used to release the drug to the outside of the inner shell 100 through the drug dispensing window 131. 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 the present application. Optionally, the second direction YY' is along the radial direction of the medical magnetically driven capsule endoscope.

[0062] Since the water-soluble protective cover is connected to the inner shell 100 and covers the medication window 131, the water-soluble protective cover can prevent the medication component from extending from the medication window 131 when the medical magnetically driven capsule endoscope moves in the patient's digestive tract. The material used for the water-soluble protective cover can be dissolved in water and has biocompatibility. In this way, after the medical magnetically driven capsule endoscope reaches the lesion position in the patient's digestive tract, the water-soluble protective cover can gradually dissolve in the body fluid in the patient's digestive tract, thereby opening the medication window 131. At this time, the medication component in the medication cavity can release the drug to the outside of the inner shell 100 through the medication window 131, that is, the drug can be released at the lesion position in the patient's digestive tract.

[0063] The hydrogel shell 400 is coated on the inner shell 100. The hydrogel shell 400 has a drug dispensing opening 401, a camera opening 402, and a lighting opening 403. The drug dispensing opening 401 can reveal the water-soluble protective cover, so that when the water-soluble protective cover is dissolved, the drug dispensing opening 401 can reveal the drug dispensing window 131, so that the drug dispensing component can release the drug outward through the drug dispensing window 131 and the drug dispensing opening 401 to release the drug to the lesion position of the patient's digestive tract.

[0064] The camera opening 402 is used for the light collecting surface of the camera module 210 to collect light. The lighting opening 403 is used for the light emitted by the light emitting surface of the lighting module 220 to be emitted. When the camera module 210 collects images in the patient's digestive tract, the light can pass through the camera opening 402 and the first transparent shell wall 110 to enter the inner shell 100, so that the camera module 210 can collect light. At the same time, the light emitted by the light emitting surface of the lighting module 220 can pass through the first transparent shell wall 110 and the lighting opening 403 to be emitted, so as to provide a lighting environment for the camera module 210 to work.

[0065] In the medical magnetically driven capsule endoscope covered with a lubricating soft shell, the endoscope assembly and the drug dispensing assembly are installed in the inner shell 100. The hydrogel shell 400 is coated on the outside of the inner shell 100. The hydrogel shell 400 is provided with a drug dispensing opening 401, a camera opening 402 and a lighting opening 403, so that the normal working conditions of the drug dispensing assembly, the camera module 210 and the lighting module 220 can be met. On this basis, since the hydrogel has the characteristics of low friction, high biocompatibility and softness, the friction between the hydrogel shell 400 and the intestinal wall is small during the movement of the medical magnetically driven capsule endoscope in the patient's intestine, and the intestinal wall is not easily damaged by friction, thereby improving safety and comfort, and being able to increase the travel speed of the medical magnetically driven capsule endoscope and improve inspection efficiency.

[0066] The materials used for the water-soluble protective cover include edible gelatin, pharmaceutical hydroxypropyl methylcellulose (HPMC), etc.

[0067] In one embodiment, the hydrogel shell 400 includes a magnetic layer. The magnetic layer is coated on the outside of the inner shell 100. The material of the magnetic layer is calcium alginate hydrogel mixed with ferroferric oxide particles. When the medical magnetically driven capsule endoscope is in the patient's digestive tract, an axial magnetic field can be applied to the patient through a magnetic navigation system outside the patient's body, so that the ferroferric oxide particles in the magnetic layer are subjected to magnetic force in the direction of the magnetic field gradient, thereby being able to drive the entire medical magnetically driven capsule endoscope to move in the patient's digestive tract, that is, to achieve active magnetic drive of the medical magnetically driven capsule endoscope. Optionally, the ferroferric oxide particles are nano-sized particles. Since the magnetic layer contains ferroferric oxide particles, the whole is black.

[0068] The specific structure of the magnetic navigation system can be referred to the prior art, which will not be described in detail.

[0069] In this embodiment, by mixing ferroferric oxide particles into calcium alginate hydrogel to form a magnetic layer, the limited space of the capsule endoscope can be fully utilized, so that the capsule endoscope has a high degree of integration and a small overall volume. In addition, ferroferric oxide nanoparticles are used, and the magnetic particles are superparamagnetic, and the direction of the magnetic force they receive changes instantly with the direction of the external magnetic field intensity gradient.

[0070] In one embodiment, the hydrogel shell 400 includes a hydrogel layer, and the hydrogel layer is coated on the outside of the magnetic layer. The material of the hydrogel layer is calcium alginate hydrogel. Since the hydrogel layer is coated on the outside of the magnetic layer, the ferroferric oxide particles in the magnetic layer can be coated, thereby preventing the ferroferric oxide particles from falling into the patient's digestive tract as much as possible.

[0071] In one embodiment, a lubricating layer is formed on the outer surface of the hydrogel layer. The material of the lubricating layer is poly (2-methacryloyloxyethyl phosphorylcholine) (PMPC), and the lubricating layer can make the outer surface of the hydrogel shell 400 more lubricated, so that the medical magnetically driven capsule endoscope can further reduce friction when it is in the patient's digestive tract.

[0072] The synthesis of poly (2-methacryloyloxyethyl phosphorylcholine) (PMPC) is formed by polymerizing 2-methacryloyloxyethyl phosphorylcholine (MPC) monomer on the outer surface of calcium alginate hydrogel. It can be seen that in this embodiment, the hydrogel layer (calcium alginate hydrogel) is coated on the outside of the magnetic layer, which facilitates the preparation of a lubricating layer on the outer surface of the hydrogel layer.

[0073] Optionally, the thickness of the lubricating layer is greater than and equal to 0.45 mm, less than and 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 cover 121. The sealing cavity is located in the front housing 120. The drug application cavity is located in the rear housing 130. The front housing 120 and the rear housing 130 are arranged along the first direction XX'.

[0075] The first transparent shell wall 110 is sealed and connected to one end of the front shell 120. An installation opening is provided at one end of the front shell 120 away from the first transparent shell wall 110, and the installation opening is used for the endoscope assembly to enter, so as to facilitate 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 blocks the installation opening, so that the sealed cavity inside the front shell 120 becomes a sealed environment to protect the endoscope assembly inside.

[0076] The rear shell 130 is connected to the end cover 121, and is indirectly connected to the front shell 120. Since the sealing chamber is located in the front shell 120 and the drug application chamber is located in the rear shell 130, the sealing chamber and the drug application chamber can be isolated. The drug application window 131 is provided on the rear shell 130. The water-soluble protective cover is connected to the rear shell 130, so as to cover the drug application window 131 on the rear shell 130.

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

[0078] In one embodiment, the front shell 120, the rear shell 130, and the end cover 121 are all made of transparent material. The material used by the front shell 120, the rear shell 130, and the end cover 121 is the same as the material used by the first transparent shell wall 110. The front shell 120, the first transparent shell wall 110, the end cover 121, and the 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 cover 121 and the front shell 120 can be fixed by bonding or the like. The rear shell 130 and the end cover 121 can be fixed by bonding or the like.

[0080] The transparent material in the embodiment of the present application is preferably a transparent biocompatible material. Transparent biocompatible materials include transparent resin, PC (polycarbonate), etc.

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

[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 module 240 .

[0083] The control module (not numbered) and the radio frequency wireless transmission module 250 are respectively disposed on the circuit board module 230. The camera module 210 and the power module 240 are respectively electrically connected to the circuit board module 230. The lighting module 220 can be disposed 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 each functional module connected to the circuit board module 230.

[0085] The host computer located outside the patient's body can transmit signals with the control module through the radio frequency wireless transmission module 250. Specifically, the host computer can send a control signal to the control module through 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 signal. The image captured by the camera module 210 can be transmitted to the control module, and the control module feeds the image back to the host computer through the radio frequency wireless transmission module 250.

[0086] Among them, the specific structures and detailed working principles of the camera module 210, the lighting module 220 (such as an LED lamp), the circuit board module 230, the control module (such as an MCU system), the power module 240 (such as a button battery), and the radio frequency wireless transmission module 250 can be referred to the existing technology and will not be repeated here.

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

[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 the 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 is electrically connected to the second circuit board 232. 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] Through this embodiment, it is convenient to electrically connect the camera module 210 and the power module 240 to the circuit board module 230 respectively, and the layout of each functional module of the endoscope assembly is compact.

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

[0091] The first circuit board 231 and the second circuit board 232 may be a rigid-flexible board or an FPC circuit board.

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

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

[0094] After the medical magnetically driven capsule endoscope reaches the lesion location in the patient's digestive tract and the water-soluble protective cover dissolves, the medication window 131 opens. At this time, a magnetic field along the second direction YY' can be applied to the patient outside the patient's body, so that the permanent magnet 320 is subjected to a magnetic driving 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 thereto 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', so that the drug-loaded microneedle can be inserted into the lesion of the patient's digestive tract.

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

[0096] Please combine Figure 4 and Figure 5 In one embodiment, the sliding part 310 includes a sliding column 311 and a push plate 312. The push plate 312 is fixedly connected to one end of the sliding column 311. The therapeutic patch 330 is arranged on the side of the push plate 312 away from the sliding column 311. One end of the permanent magnet 320 is fixedly connected to the push plate 312. A guide cylinder 132 is arranged at the bottom of the medication cavity. The sliding column 311 and the guide cylinder 132 are slidably matched along the second direction YY', so that the moving direction of the sliding column 311 can be limited, and then the moving direction of the sliding part 310 as a whole can be limited.

[0097] Please combine Figure 4 and Figure 5In one embodiment, a stop rod 133 is provided at the bottom of the medicine dispensing chamber, and a stop hook 134 is provided at one end of the stop rod 133 away from the bottom of the medicine dispensing chamber. The sliding part 310 includes an anti-slip rod 314, one end of which is fixedly connected to the push plate 312, and the other end of the anti-slip rod 314 is provided with an anti-slip hook 315. The stop hook 134 is located on the side of the anti-slip hook 315 close to the push plate 312 along the second direction YY'. In this way, when the sliding part 310 moves toward the outside of the medicine dispensing chamber along the second direction YY', when the stop hook 134 hooks the anti-slip hook 315, the anti-slip hook 315 can be prevented from continuing to move toward the outside of the medicine dispensing chamber, thereby preventing the sliding part 310 from leaving the medicine dispensing chamber.

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

[0099] The sealing shell 316 is arranged around the permanent magnet 320, the sliding column 311 and the anti-drop rod 314. The sealing shell 316 is sealed with the cavity wall of the medication cavity, and the sealing shell 316 can move relative to the cavity wall of the medication cavity along the second direction YY'. The push plate 312 closes the end of the sealing shell 316 away from the bottom of the medication cavity. In this way, it is possible to prevent the substances in the patient's digestive tract from entering the space surrounded by the push plate 312 and the sealing shell 316, thereby protecting the permanent magnet 320 and other components inside the medication assembly.

[0100] Please refer to Figure 6 An embodiment of the present application provides a method for preparing a medical magnetically driven capsule endoscope coated with a lubricating soft shell, which is used to prepare the medical magnetically driven capsule endoscope of any of the above embodiments, and the preparation method comprises the following steps:

[0101] S100: Provide an inner shell 100 and install the endoscope assembly in the sealed cavity.

[0102] S200 : Covering the inner shell 100 with a hydrogel shell 400 , and forming a drug administration opening 401 , a camera opening 402 , and a lighting opening 403 on the hydrogel shell 400 .

[0103] S300: Install the drug dispensing assembly in the drug dispensing cavity, and then connect the water-soluble protective cover to the inner shell to cover the drug dispensing window 131. This step is to install the drug dispensing assembly and the water-soluble protective cover after the preparation of the hydrogel shell 400 is completed, which can avoid the influence of the preparation environment on the drug dispensing assembly and the water-soluble protective cover during the preparation of the hydrogel shell 400, thereby facilitating the preparation of the hydrogel shell 400.

[0104] In the preparation method of the medical magnetically driven capsule endoscope coated with the lubricating soft shell, the endoscope assembly and the drug dispensing assembly are installed in the inner shell 100. The hydrogel shell 400 is coated on the outside of the inner shell 100, and a drug dispensing opening 401, a camera opening 402 and a lighting opening 403 are formed on the hydrogel shell 400, so that the normal working conditions of the drug dispensing assembly, the camera module 210 and the lighting module 220 can be met. On this basis, since the hydrogel has the characteristics of low friction, high biocompatibility and softness, the friction between the hydrogel shell 400 and the intestinal wall is small during the movement of the medical magnetically driven capsule endoscope in the patient's intestine, and the intestinal wall is not easily damaged by friction, thereby improving safety and comfort, and being able to increase the travel speed of the medical magnetically driven capsule endoscope and improve inspection efficiency.

[0105] In one embodiment, step S200 includes:

[0106] S210: placing the inner shell 100 with the endoscope assembly installed in the first mold, pouring a water suspension mixed with sodium alginate and ferrosoferric oxide particles between the inner shell 100 and the first mold, freezing the water suspension in the first mold into a first solid structure, and then demolding from the first mold.

[0107] The aqueous suspension mixed with sodium alginate and ferroferric oxide particles is used to make the magnetic layer of the hydrogel shell 400. The shape of the cavity defined between the inner cavity 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 wrapped in the first fixed structure, and an endoscope assembly installed in the inner shell 100.

[0108] The magnetic layer is prepared by pouring an aqueous suspension mixed with sodium alginate and ferroferric oxide particles into the first mold. The resulting magnetic layer can fully fill 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, space is saved to allow more other functional modules to be installed inside the capsule endoscope.

[0109] S220: placing the first solid structure coated with the inner shell 100 into the second mold, pouring an aqueous solution mixed with sodium alginate and a photoinitiator between the first solid structure and the second mold, freezing the aqueous solution in the second mold into the second solid structure, and then demolding from the second mold.

[0110] The aqueous solution mixed with sodium alginate and photoinitiator is used to make the hydrogel layer of the hydrogel shell 400. The shape of the cavity defined between the inner cavity 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: placing the structure demoulded from the second mold into a calcium chloride aqueous solution for immersion to form a capsule matrix; wherein the sodium alginate in the second solid structure is chemically cross-linked with the calcium chloride in the calcium chloride aqueous solution to form a calcium alginate hydrogel, and the sodium alginate in the first solid structure is chemically cross-linked with the calcium chloride in the calcium chloride aqueous solution to form a calcium alginate hydrogel, so that the first solid structure is converted into a calcium alginate hydrogel mixed with ferrosoferric oxide particles.

[0112] The structure after demolding from the second mold includes: the second solid structure, the first solid structure wrapped in the second solid structure, the inner shell 100 wrapped in the first fixed structure, and the endoscope assembly installed in the inner shell 100.

[0113] In this step, when the structure demoulded from the second mold is immersed in a calcium chloride aqueous solution, the sodium alginate in the second solid structure and the calcium chloride in the calcium chloride aqueous solution are chemically cross-linked to form a calcium alginate hydrogel, thereby forming a hydrogel layer; the sodium alginate in the first solid structure and the calcium chloride in the calcium chloride aqueous solution are chemically cross-linked to form a calcium alginate hydrogel, so that the first solid structure is converted into a calcium alginate hydrogel mixed with ferroferric oxide particles, thereby forming a magnetic layer. In this way, the capsule matrix is ​​obtained. It can be understood that the capsule matrix includes an inner shell 100, an endoscope assembly, a magnetic layer, and a hydrogel layer.

[0114] S240: Soaking the capsule matrix in a 2-methacryloyloxyethyl phosphorylcholine solution, and irradiating the surface of the capsule matrix with an ultraviolet lamp, so that the 2-methacryloyloxyethyl phosphorylcholine is polymerized on the outer surface of the calcium alginate hydrogel to form poly (2-methacryloyloxyethyl phosphorylcholine).

[0115] In this step, during the process of the capsule matrix being immersed in the 2-methacryloyloxyethyl phosphorylcholine solution, the hydrogel layer (i.e., calcium alginate hydrogel) is in the 2-methacryloyloxyethyl phosphorylcholine solution environment; since the surface of the capsule matrix is ​​irradiated with an ultraviolet lamp at the same time, the photoinitiator in the hydrogel layer will induce the polymerization of 2-methacryloyloxyethyl phosphorylcholine, thereby forming poly (2-methacryloyloxyethyl phosphorylcholine) on the surface of the hydrogel layer. The model of the photoinitiator is, for example, I2989 photoinitiator. It can be seen that the lubricating layer is made by the polymerization of 2-methacryloyloxyethyl phosphorylcholine on the surface of the calcium alginate hydrogel.

[0116] In one embodiment, the 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 period 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] The inventors have found through experiments that after step S220, placing the structure demoulded from the second mold in a temperature environment of w for a time of t can make the first solid structure and the second solid structure in a state of being about to melt but not melted, so that when step S230 is performed, the sodium alginate and calcium chloride are chemically cross-linked to form a calcium alginate hydrogel with good texture and performance. Preferably, w is 4°C and t is 15min.

[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 structure demoulded from the second mold is immersed in the calcium chloride aqueous solution for a time greater than or equal to 18 minutes and less than or equal to 22 minutes. Optionally, the mass fraction of calcium chloride is 2.5%.

[0119] In one embodiment, in the aqueous 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%. Optionally, in the aqueous suspension mixed with sodium alginate and ferroferric oxide particles, the mass fraction of sodium alginate is 10%, and the mass fraction of ferroferric oxide particles is 5%.

[0120] In one embodiment, in the aqueous solution mixed with 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 mixed with 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, in the 2-methacryloyloxyethyl phosphorylcholine solution, the mass fraction of 2-methacryloyloxyethyl phosphorylcholine is greater than or equal to 9% and less than or equal to 11%, preferably 10%. The irradiation time of the ultraviolet lamp on the capsule matrix is ​​greater than or equal to 110 minutes and less than or equal to 130 minutes. Preferably, the irradiation time of the ultraviolet lamp on the capsule matrix is ​​120 minutes.

[0122] The technical features of the above-described embodiments may be arbitrarily combined. To make the description concise, not all possible combinations of the technical features in the above-described 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 above-described embodiments only express several implementation methods of the present application, and the descriptions thereof are relatively specific and detailed, but they cannot be construed as limiting the scope of the patent application. It should be pointed out that, for a person of ordinary skill in the art, several variations and improvements can be made without departing from the concept of the present application, and these all belong to the protection scope of the present application. Therefore, the protection scope of the patent application shall be subject to the attached claims.

Claims

1. A medical magnetically driven capsule endoscope covered with a lubricating soft shell, characterized in that: include: Inner shell, endoscope assembly, water-soluble protective cover, drug application assembly and hydrogel shell; The inner shell has a sealing cavity and a drug application cavity which are arranged along a first direction and isolated from each other; The endoscope assembly is located in the sealed cavity, and the endoscope assembly includes a camera module and a lighting module; one end of the inner shell has a first transparent shell wall, and the first transparent shell wall is located at an end of the sealed cavity away from the medication cavity; the light-emitting surface of the lighting module and the light-collecting surface of the camera module are respectively opposite to the first transparent shell wall; The inner shell is provided with a drug dispensing window which is in communication with the drug dispensing cavity and faces a second direction, the water-soluble protective cover is connected to the inner shell and covers the drug dispensing window; the drug dispensing assembly is located in the drug dispensing cavity, and the drug dispensing assembly is used to release the drug to the outside of the inner shell through the drug dispensing window, and the second direction is perpendicular to the first direction; The hydrogel shell is coated on the outside of the inner shell, and is provided with a drug application opening, a camera opening and a lighting opening. The drug application opening can reveal the water-soluble protective cover, the camera opening is used for the lighting surface to collect light, and the lighting opening is used for the light emitted by the light-emitting surface to emit.

2. The medical magnetically driven capsule endoscope according to claim 1, characterized in that: The hydrogel shell comprises: A magnetic layer, the magnetic layer is coated on 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 is coated on the outside of the magnetic layer, and the material of the hydrogel layer is calcium alginate hydrogel.

3. The medical magnetically driven capsule endoscope according to claim 2, characterized in that: A lubricating layer is formed on the outer surface of the hydrogel layer, and the material of the lubricating layer is poly (2-methacryloyloxyethyl phosphorylcholine).

4. The medical magnetically driven capsule endoscope according to claim 1, characterized in that: The endoscope assembly also includes a circuit board module, a control module, a radio frequency wireless transmission module and a power module. 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 to the circuit board module; The power supply 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.

5. The medical magnetically driven capsule endoscope according to claim 4, characterized in that: The circuit board module is located between the camera module and the power module along the first direction; The circuit board module includes a first circuit board and a second circuit board stacked along the first direction, the first circuit board is electrically connected to the second circuit board; the camera module and the lighting module are electrically connected to the first circuit board respectively, and the power module is electrically connected to the second circuit board.

6. The medical magnetically driven capsule endoscope according to claim 1, characterized in that: The drug dispensing assembly comprises: A sliding portion, wherein the sliding portion is slidably connected to the medication cavity along the second direction; a permanent magnet fixedly connected to the sliding portion; and The treatment patch is connected to one end of the sliding part facing the outside of the drug application window, and the side of the treatment patch facing the outside of the drug application window is provided with drug-carrying microneedles.

7. A method for preparing a medical magnetically driven capsule endoscope coated with a lubricating soft shell, characterized in that: Used to prepare the medical magnetically driven capsule endoscope according to any one of claims 1 to 6, the preparation method comprising the following steps: providing the inner housing, and installing the endoscope assembly in the sealed cavity; The hydrogel shell is wrapped on the outside of the inner shell, and the drug application opening, the camera opening and the lighting opening are formed on the hydrogel shell; The medicine dispensing assembly is installed in the medicine dispensing cavity, and then the water-soluble protective cover is connected to the inner shell to cover the medicine dispensing window.

8. The preparation method according to claim 7, characterized in that: The steps of covering the hydrogel shell on the outside of the inner shell and forming the drug dispensing opening, the camera opening and the lighting opening on the hydrogel shell include: The inner housing with the endoscope assembly installed therein is placed in a first mold, a water suspension mixed with sodium alginate and ferroferric oxide particles is poured between the inner housing and the first mold, the water suspension is frozen into a first solid structure, and then demolded from the first mold; placing the first solid structure covered with the inner shell into a second mold, pouring an aqueous solution mixed with sodium alginate and a photoinitiator between the first solid structure and the second mold, freezing the aqueous solution into a second solid structure, and demolding from the second mold; The structure demoulded from the second mold is immersed in a calcium chloride aqueous solution to form a capsule matrix, wherein the sodium alginate in the second solid structure is chemically cross-linked with the calcium chloride in the calcium chloride aqueous solution to form a calcium alginate hydrogel, and the sodium alginate in the first solid structure is chemically cross-linked with the calcium chloride in the calcium chloride aqueous solution to form a calcium alginate hydrogel, so that the first solid structure is converted into a calcium alginate hydrogel mixed with ferrosoferric oxide particles; The capsule matrix is ​​immersed in a 2-methacryloyloxyethyl phosphorylcholine solution, and the surface of the capsule matrix is ​​irradiated with an ultraviolet lamp, so that the 2-methacryloyloxyethyl phosphorylcholine is polymerized on the outer surface of the calcium alginate hydrogel to form poly (2-methacryloyloxyethyl phosphorylcholine).

9. The preparation method according to claim 8, characterized in that: The preparation method further comprises: after the step of freezing the aqueous solution into a second solid structure and demolding the solution from 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, placing the structure demoulded from the second mold in a temperature environment of w for a time 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; 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 structure demoulded from the second mold is immersed in the calcium chloride aqueous solution for a time period greater than and equal to 18 minutes and less than and equal to 22 minutes.

10. The preparation method according to claim 8, characterized in that: In the aqueous 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%; In the aqueous solution mixed with 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%.

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