Sampling capsule and sampling capsule system

Abstract

The application provides a sampling capsule, comprising a shell, a sampling assembly, a film bacteria collection auxiliary assembly and a control module; the sampling assembly comprises a sampling pool arranged in the shell, an outer sampling port arranged on the shell, a communication pipe communicated with the outer sampling port and the sampling pool, and a sampling switch for opening or closing the communication pipe; the film bacteria collection auxiliary assembly comprises a vibration motor arranged in the shell and / or a counterweight arranged at the outer sampling port; and the control module comprises a microprocessor communicated with the sampling switch and the vibration motor. The film bacteria collection auxiliary assembly can assist the sampling assembly to collect film bacteria, and the sampling switch can timely open / close the communication pipe, so that the sampling is more accurate, the sample leakage or contamination can be prevented, and the universality of the sampling capsule is improved.

Description

TECHNICAL FIELD

[0001] The present application relates to the technical field of medical devices, in particular to a sampling capsule for collecting digestive tract membrane flora and a sampling capsule system. BACKGROUND

[0002] The sampling capsule is an intelligent capsule for sampling digestive juice at a digestive tract site. Taking sampling of intestinal juice as an example, intestinal microorganisms are closely related to human health, and medical research has found that more and more diseases are related to intestinal microorganisms, such as cardiovascular diseases, obesity, diabetes, various intestinal diseases (IBD, IBS, CD, SIBO, etc.), liver diseases, allergies, immune diseases, nervous system diseases (autism, depression, senile dementia), cancer, hypertension, chronic kidney disease, etc. In order to further study the pathology of these diseases, intestinal flora, especially the distribution and abundance of flora in the large and small intestines, has received more and more attention.

[0003] The species and abundance of large and small intestinal flora are obviously different, so they need to be studied separately. At the same time, due to the structure of the digestive tract itself and the characteristics of bacterial colony reproduction, intestinal flora can be divided into membrane flora, also known as mucosal flora, and cavity flora, also known as intestinal cavity flora. The fluidity of cavity flora is stronger, so the abundance, distribution and species are different from the membrane flora at the same site. The bacterial colonies of membrane flora are mostly colonized in the mucus layer of the mucosa, so the abundance of membrane flora is relatively high. The research on membrane flora has higher value.

[0004] The current more traditional intestinal flora analysis methods are, for example, enteroscopy aspiration, enteroscopy mucosa collection, fecal analysis, hydrogen breath test, etc. However, these methods either need to use an enteroscope, which will cause more pain to the tester, or can only analyze the flora in the rear end of the colon and rectum, and there are few research methods for the membrane flora of the small intestine, especially the terminal ileum.

[0005] Intestinal microorganism collection technology based on capsule endoscopy has the advantages of comfort and full coverage of the digestive tract, so it will become an effective tool for research in this field. At present, there are many designs of collection systems based on capsule endoscopy, which can be roughly divided into tissue sampling and liquid sampling systems according to the nature of the collected samples.

[0006] The tissue sampling system is large in size and complex in structure. During biopsy, a collection device such as a blade or biopsy forceps needs to be extended from the capsule system. For details, refer to "Research on biopsy mechanism of capsule robot", "A rotational microbiopsy device for the capsule endoscope", "A novel microactuator for microbiopsy in capsular endoscopes", "Shape memory alloy based biopsy device for active locomotive intestinal capsule endoscope", "Magnetic torsion spring mechanism for a wireless biopsy capsule", "Design of Micro Biopsy Device for Wireless Autonomous Endoscope", and the like. Since the control and positioning capabilities of the capsule endoscope system are significantly weaker than those of the traditional intubation endoscope, it is difficult to fix the biopsy and it is impossible to perform postoperative hemostasis and other treatments, so the tissue sampling system has certain safety risks.

[0007] The liquid collection system usually absorbs the liquid in the digestive tract by some power such as the adsorption force of water-absorbing materials, the suction force of a micro pump, vacuum suction, and the like, and analyzes the flora in the liquid after recovery. For details, refer to "Ingestible Gastrointestinal Sampling Devices: State-of-the-Art and Future Directions", "The study of a remote-controlled gastrointestinal drug delivery and sampling system", and the like. The system is high in safety and success rate of collection. However, these systems can usually only absorb the liquid in the cavity, and mainly analyze the cavity flora, without an effective solution for collecting the membrane flora.

[0008] Therefore, it is necessary to provide an improved sampling capsule and sampling capsule system to solve the above problems. SUMMARY

[0009] The purpose of the present application is to provide a sampling capsule and a sampling capsule system for collecting the membrane flora of the digestive tract.

[0010] To achieve the above-mentioned purposes, the present application adopts the following technical solutions:

[0011] A sampling capsule comprises a shell, a sampling assembly, a membrane bacteria collection auxiliary assembly and a control module; the sampling assembly comprises a sampling pool arranged in the shell, an outer sampling port arranged on the shell, a communication pipe communicating the outer sampling port and the sampling pool, and a sampling switch opening or closing the communication pipe; the membrane bacteria collection auxiliary assembly comprises a vibration motor arranged in the shell and / or a counterweight arranged at the outer sampling port; the control module comprises a microprocessor in communication connection with the sampling switch and the vibration motor.

[0012] As a further improvement of the present application, the sampling assembly comprises a plurality of outer sampling ports arranged on the shell, and a sampling cavity in communication with the plurality of outer sampling ports, and the communication pipe is in communication with the sampling cavity.

[0013] As a further improvement of the present application, the plurality of outer sampling ports are distributed along the circumferential direction of the sampling capsule.

[0014] As a further improvement of the present application, the aperture of each outer sampling port is smaller than the aperture of the communication pipe.

[0015] As a further improvement of the present application, the sampling cavity has a filter structure.

[0016] As a further improvement of the present application, the vibration motor is a button type vibration motor, a hollow cup motor with eccentric device or a linear vibration motor.

[0017] As a further improvement of the present application, the vibration motor is located at the center of the sampling capsule.

[0018] As a further improvement of the present application, the counterweight is a magnetic member, and the center of gravity of the magnetic member is biased towards the side of the magnetic member close to the shell.

[0019] As a further improvement of the present application, one side of the magnetic member is an arc surface matched with the shell, and the magnetic member is a radially magnetized magnetic member.

[0020] As a further improvement of the present application, the magnetic member and the outer sampling port are arranged side by side along the axial direction of the sampling capsule.

[0021] As a further improvement of the present application, the sampling capsule further comprises an extraction assembly, the extraction assembly comprises an extraction port arranged on the shell and in communication with the sampling pool, a fixing member matched with the extraction port, and a silica gel plug assembled in the fixing member.

[0022] As a further improvement of the present application, the control module further comprises a sensor for collecting physiological parameters and / or image information in the digestive tract, and the sensor is in communication connection with the microprocessor.

[0023] Alternatively, the control module further includes a sensor for collecting physiological parameters and / or image information in the digestive tract, and a storage module for storing normal physiological parameters or image information of different parts of the digestive tract, as well as physiological parameters or image information of possible pathological conditions, and both the sensor and the storage module are communicatively connected to the microprocessor;

[0024] Or the control module further includes a sensor for collecting physiological parameters and / or image information in the digestive tract and a wireless transmission module for communication with an external processing terminal, and the sensor is communicatively connected to the microprocessor.

[0025] As a further improvement of the present invention, the sensor is at least one of an image sensor, a pH sensor, and an ultrasonic sensor; when the sensor includes an image sensor, part of the shell is transparent; when the sensor includes a pH sensor, the shell has a window.

[0026] The present invention also provides a sampling capsule system, comprising the above-mentioned sampling capsule and an external processing terminal communicatively connected to the control module.

[0027] Compared with existing technologies, the present invention has the following advantages: the sampling capsule of the present invention, through the membrane flora collection auxiliary component, can assist the sampling component in collecting membrane flora; the sampling switch opens and closes the connecting tube to enable sampling, and after sampling is completed, the sampling switch closes the connecting tube to prevent sample leakage or contamination; and the sample volume can be precisely controlled by controlling the conduction state and conduction time of the connecting tube. In addition, the active control of the conduction or closure of the connecting tube by the sampling switch is not affected by the specific environment of the digestive tract, and can be used in any part of the digestive tract, with high versatility. BRIEF DESCRIPTION OF THE DRAWINGS

[0028] Figure 1 is a cross-sectional view of a sampling capsule according to a preferred embodiment of the present invention cut along the axial direction;

[0029] Figure 2 yes Figure 1 A cross-sectional view of the sampling capsule shown along the radial direction;

[0030] Figure 3 It can be used for Figure 1 The structure diagram of the magnetic component of the sampling capsule in one embodiment is shown;

[0031] Figure 4 It can be used for Figure 1 The structure diagram of the magnetic member of the sampling capsule in another embodiment is shown;

[0032] Figure 5is capable of being used for Figure 1 Structure diagram of the magnetic part of the sampling capsule shown in another embodiment;

[0033] Figure 6 is capable of being used for Figure 1 Structure diagram of the magnetic part of the sampling capsule shown in another embodiment;

[0034] Figure 7 is capable of being used for Figure 1 Structure diagram of the magnetic part of the sampling capsule shown in another embodiment;

[0035] Figure 8 is a schematic diagram of the sampling capsule of the present application when sampling the film flora;

[0036] Figure 9 is a schematic diagram of the direction defined based on the sampling capsule in the present application. Specific embodiments

[0037] The present application will be described in detail below with reference to the specific embodiments shown in the accompanying drawings. However, these embodiments do not limit the present application, and the changes in structure, method, or function made by those of ordinary skill in the art based on these embodiments are all within the scope of protection of the present application.

[0038] In various diagrams of the present application, the sizes of some structures or parts are exaggerated relative to other structures or parts for ease of illustration, and therefore only serve to illustrate the basic structure of the subject matter of the present application.

[0039] In addition, "and / or" used herein means "or" or "and", for example, "M and / or N" includes M, or N, or M and N.

[0040] Please refer to Figures 1 and 2 As shown in the drawings, the sampling capsule 100 of the preferred embodiment of the present application includes a shell 1, a sampling assembly 2 for sampling the film flora, a film flora collection auxiliary assembly 3 for assisting in collecting the film flora, and a control module 4. The control module 4 includes a microprocessor in communication with at least part of the structures in the other assemblies to control and / or coordinate the working state of the other assemblies.

[0041] The shell 1 is biocompatible and will not be corroded by digestive fluids, and can be transparent or opaque as needed. Moreover, the shell 1 is formed by splicing at least two parts to facilitate the installation of internal structures. For example Figure 1 As shown, the shell 1 is composed of a first shell 11 and a second shell 12 distributed along the length direction of the sampling capsule 100, and the two parts are connected by threads, adhesives, etc.

[0042] The sampling assembly 2 comprises a sampling pool 21 arranged in the shell 1, an outer sampling port 22 arranged on the shell 1, a communication pipe 23 communicating the outer sampling port 22 and the sampling pool 21, and a sampling switch 24 opening or closing the communication pipe 23.

[0043] Specifically, the sampling capsule 100 further comprises a partition wall 13 arranged in the shell 1, the partition wall 13 and the shell 1 on the first side of the partition wall 13 form the sampling pool 21, the outer sampling port 22 is located on the second side of the partition wall 13, and the sampling assembly 2 further comprises an inner sampling port 25 arranged on the partition wall 13, and the communication pipe 23 communicates the outer sampling port 22 and the inner sampling port 25.

[0044] The partition wall 13 is arranged integrally with the shell 1 on the first side of the partition wall 13, and the sealing performance of the sampling pool 21 formed thereby is good; or the partition wall 13 is arranged separately from the shell 1 on the first side of the partition wall 13, and the sealing performance at the connection between the two is required to ensure that the sampling pool 213 can maintain the required vacuum degree.

[0045] Before use, the sampling pool 21 is sterilized, and the sampling pool 21 is vacuumized, and the absolute pressure is between 0 hPa and 260 hPa. The method for vacuumizing the sampling pool 21 includes but is not limited to: before the manufacturing is completed, the communication pipe 23 is opened, the air in the sampling pool 21 is extracted by an air extraction element, after the required vacuum degree is reached, the communication pipe 23 is closed, so that the sampling pool 21 maintains the required vacuum degree. Or before use, the sampling pool 21 is extracted to the required vacuum degree by the air extraction element from the extraction assembly 7.

[0046] The communication pipe 23 is a hose, preferably a silica gel pipe. The communication pipe 23 and the partition wall 13 are connected by a connecting piece 26, so that the communication pipe 23 is sealed and communicated with the inner sampling port 25.

[0047] The connecting piece 26 is UV glue, which is used to bond the communication pipe 23 and the peripheral wall forming the inner sampling port 25; or the connecting piece 26 is a rubber ring, which is sleeved on the outside of the communication pipe 23 or nested in the inner sampling port 25, and after assembly, the rubber ring is interference fit between the communication pipe 23 and the inner sampling port 25, playing a sealing and connecting role.

[0048] In addition, the sampling switch 24 is arranged at the middle position of the communication pipe 23, and the communication pipe 23 on both sides of the sampling switch 24 can be one silica gel pipe or two separate communication pipes 23.

[0049] The sampling switch 24 is a piezoelectric micro valve, a shape memory metal micro valve, a gas pipe clamp, etc., wherein the piezoelectric micro valve and the shape memory metal micro valve adopt the prior art for opening and closing control of the communication pipe 23, which will not be described here; and the gas pipe clamp can refer to the technical solutions in the patent applications 201811219936.8, 201811219926.4, and 201810617763.9, which will not be described here.

[0050] The sampling switch 24 is in a closed state in a normal state, maintaining the vacuum degree in the sampling pool 21 and the communication pipe 23 connected between the sampling pool 21 and the sampling switch 24, so it can withstand at least one atmospheric pressure. When the microprocessor receives a sampling instruction transmitted wirelessly, the microprocessor controls the sampling switch 24 to open the communication pipe 23 for sampling. After sampling is completed, the sampling switch 24 is controlled to be closed to prevent sample leakage or contamination by downstream substances in the digestive tract.

[0051] Further, as shown in Figure 1 Especially Figure 2 As shown, the sampling assembly 2 includes a plurality of outer sampling ports 22 opened on the shell 1, a sampling cavity 22' in communication with the plurality of outer sampling ports 22, and the communication pipe 23 in communication with the sampling cavity 22' to indirectly communicate with the outer sampling ports 22. The gas and liquid in the digestive tract enter the sampling cavity 22' through the outer sampling ports 22 and gather into the communication pipe 23, so even if part of the outer sampling ports 22 are blocked, part of them remain open, which will not affect sampling. In addition, the digestive fluid entering through each outer sampling port 22 can be mixed and buffered through the sampling cavity 22', ensuring that sampling is uniform and smooth.

[0052] The plurality of outer sampling ports 22 are spaced apart along the circumferential direction of the sampling capsule 100, and preferably, the plurality of outer sampling ports 22 are arranged at equal intervals. In this embodiment, the shell 1 is provided with 3-5 outer sampling ports 22, which can ensure smooth sampling without affecting the strength of the shell 1.

[0053] Preferably, the aperture of each outer sampling port 22 is smaller than the aperture of the communication pipe 23, so that the substances entering the sampling cavity 22' through the outer sampling ports 22 will not block the communication pipe 23.

[0054] Further, the sampling cavity 22' has a filtering structure (not shown), such as but not limited to a filter screen, to prevent food residues from blocking the communication pipe 23. The filtering structure can refer to the patent application No. 201811330328.4 "Structure Design for Preventing Blockage and Air Absorption in Digestive Fluid Sampling Capsule 100 System".

[0055] In conjunction with any one of the above-mentioned sampling components 2 , the membrane flora collection auxiliary component 3 includes a vibration motor 31 provided in the housing 1 and / or a counterweight 32 provided at the external sampling port 22 .

[0056] Generally, when the sampling capsule 100 is in the digestive tract portion to be examined, or reaches the digestive tract portion with a lesion, sampling can be performed. When the sampling capsule 100 reaches the digestive tract portion to be sampled, the sampling capsule 100 is immersed in the digestive fluid under the action of the counterweight 32, and the external sampling port 22 is directed toward and close to the digestive tract wall; or Figure 8 As shown, the vibration motor 31 is turned on to cause the sampling capsule 100 to vibrate and thereby disturb the digestive fluid in the digestive tract, allowing the membrane flora to enter the digestive fluid; or the counterweight 32 and the vibration motor 31 work simultaneously, and then the connecting tube 23 is opened through the sampling switch 24, and the digestive fluid with the membrane flora enters the sampling pool 21 through the external sampling port 22 and the connecting tube 23 under the internal and external pressure difference, thereby achieving sampling. After the sampling is completed, the connecting tube 23 is closed by the sampling switch 24 to prevent the sample from leaking or being contaminated; and by controlling the conduction state and conduction time of the connecting tube 23, the injection volume can be precisely controlled. In addition, the active control of the conduction or closure of the connecting tube 23 by the sampling switch 24 is not affected by the special environment of the digestive tract, and can be used in any part of the digestive tract, with high versatility.

[0057] When the vibration motor 31 is turned on, the sampling capsule 100 can be vibrated in the digestive tract. On the one hand, it can disturb the surrounding liquid environment and allow some bacterial colonies in the mucus layer to enter the intestinal digestive fluid; on the other hand, the vibrating capsule can more easily squeeze open the folds of the digestive tract, so that the sampling capsule 100 is close to the inner wall of the digestive tract, allowing the external sampling port 22 to contact the mucus layer.

[0058] Preferably, the vibration motor 31 is located at the center of the sampling capsule 100, which can drive the sampling capsule 100 to vibrate relatively smoothly, avoid deflection, and make its vibration easy to control. The "center position" here does not refer to the geometric center of symmetry, but rather a small area around the center of symmetry that can cause the sampling capsule 100 to vibrate smoothly. For example, the vibration motor 31 is located at the center of the sampling capsule 100 along its axial direction.

[0059] Preferably, the vibration amplitude of the vibration motor 31 is adjustable, so that the appropriate vibration amplitude can be adopted according to the specific situation, which is conducive to better obtaining the film flora. Specifically, the vibration motor 31 is in communication connection with the microprocessor, and an external device can send instructions to the sampling capsule 100 wirelessly, and the microprocessor adjusts the output frequency and speed of the vibration motor 31 according to the instructions, so as to adjust the vibration amplitude. Specifically, it can be realized by adjusting the input voltage or current of the motor; for example, PWM (Pulse Width Modulation) technology can be used for adjustment.

[0060] Specifically, the vibration motor 31 can be a button type vibration motor, a hollow cup motor plus an eccentric device, or a linear vibration motor. Preferably, the button type vibration motor has the smallest thickness and occupies less space; in addition, the vibration direction of the linear vibration motor is adjusted to be perpendicular to the outer sampling port 22.

[0061] Please refer to Figure 9 The direction of the outer sampling port 22 is defined as the X direction: taking the center of the sampling capsule 100 as the origin, when the outer sampling port 22 is 1, the direction of the origin pointing to the outer sampling port 22 is the X direction; when the outer sampling port 22 is multiple, taking the outer sampling port 22 located at the center as the end point, the direction from the origin to the end point is the X direction, for example, when there are three outer sampling ports 22, the second one is the end point; for example, when there are four outer sampling ports 22, the midpoint of the middle two is the end point. The direction of the long axis of the sampling capsule 100 is defined as the Z direction, and the Y direction is along the diameter direction of the sampling capsule 100, wherein the vibration direction of the linear vibration motor can be along the Y direction or the Z direction, which is perpendicular to the X direction.

[0062] The counterweight 32 makes the center of gravity of the sampling capsule 100 deviate towards the outer sampling port 22. When the sampling capsule 100 enters the sampling position, the sampling capsule 100 sinks into the digestive juice under the action of the counterweight 32, so that the outer sampling port 22 is directed towards and close to the digestive tract wall, facilitating the sampling of the film flora.

[0063] Preferably, as shown in Figures 3 to 7 The counterweight 32 is a magnetic member, and the center of gravity of the magnetic member deviates towards the side of the magnetic member close to the shell 1. It can not only play the role of the counterweight 32, but also control the capsule movement or change the posture through an external magnetic field, so that the outer sampling port 22 is aligned with the digestive tract wall. When the sampling capsule 100 contains a vibration motor 31, and the vibration motor also contains a magnet, the magnetization direction of the magnet and the magnetic member is as consistent as possible to avoid affecting the magnetic control effect.

[0064] Specifically, one side of the magnetic member is an arc surface matching the shell 1, so that the magnetic member can be as close as possible to the shell 1 when installed, and its center of gravity is closer to the shell 1; and it is easy to control by an external magnetic field.

[0065] Further, the magnetic member is a radially magnetized magnetic member, which is more conducive to being controlled by the external magnetic field.

[0066] For example, the magnetic member is a radially magnetized ring-shaped, fan-shaped or partial ring-shaped neodymium iron boron permanent magnet.

[0067] When the magnetic member is fan-shaped or partial ring-shaped, its center of gravity deviates from the center of the circle and is biased towards one side of the outer sampling port 22, which plays a counterweight effect, i.e., the center of gravity of the magnetic member is between the axis of the sampling capsule 100 and the outer sampling port 22. Moreover, the shorter the length of the magnetic member, the smaller the opening angle, and the closer the center of gravity to the outer sampling port 22.

[0068] Preferably, the fan angle of the magnetic member is the same as the fan angle of the outer sampling port 22. The fan angle of the outer sampling port 22 refers to the fan angle of the fan formed by connecting the two ends of the outer sampling port 22 along the radial direction of the central axis of the sampling capsule 100; when the sampling capsule 100 includes multiple outer sampling ports 22, the fan angle of the outer sampling port 22 refers to the fan angle of the fan formed by connecting the two ends of the two outer sampling ports 22 along the radial direction of the central axis of the sampling capsule 100.

[0069] For the partial ring structure, if the thickness and the radius are the same, the larger the ring, the larger the opening angle, and the closer the center of gravity to the center of the circle; the smaller the ring, the smaller the opening angle, and the farther the center of gravity from the center of the circle. However, the smaller the opening angle, the smaller the size of the magnetic member, and accordingly, the magnetic moment strength decreases, and the magnetic control ability weakens; at the same time, its weight decreases, and the influence on the overall capsule center of gravity distribution also weakens, so the opening angle design with the best magnetic control and counterweight effect needs to be selected according to the overall capsule weight and volume design.

[0070] The magnetic member is installed near the outer sampling port 22, and specifically, the magnetic member is arranged side by side with the outer sampling port 22 along the axial direction of the sampling capsule 100, so that the center of gravity of the sampling capsule 100 is biased towards one end of the sampling port, playing a counterweight role, and at the same time, the capsule movement or posture can be controlled by an external magnetic field.

[0071] During sampling, the sampling capsule 100 can be controlled by an external magnetic field to be close to the intestinal wall, and the posture is changed so that the outer sampling port 22 faces the intestinal mucosa (see Figure 2In the natural state, the outer sampling port 22 is more likely to be downward, submerged in the liquid surface. In this way, when the external magnetic control is difficult to affect the capsule, such as too far away to cause the magnetic force to be too weak, etc., the outer sampling port 22 is still more likely to be submerged in the liquid, facilitating sampling.

[0072] In addition, the sampling capsule 100 also includes a pressure sensor 5 arranged in the sampling pool 21, which has the following functions: 1. Before taking the sampling capsule 100, detecting whether the sampling capsule 100 is effective; 2. Before sending the sampling instruction, detecting whether the sampling capsule 100 is effective; 3. Determining whether the sampling is normally carried out; 4. Determining whether the sampling is ended.

[0073] Preferably, the absolute pressure measurement range of the pressure sensor 5 is 260 hPa-1260 hPa or 300 hPa-1100 hPa. If the 260 hPa-1260 hPa chip is selected, when the pressure is lower than 260 hPa, it still shows 260 hPa. Therefore, after the sampling pool 21 is pumped, the pressure value is observed, and if it shows 260 hPa, it means that the absolute pressure is ≤260 hPa, i.e. 0 hPa-260 hPa. If the 300-1100 hPa chip is selected, when the actual pressure is lower than 300 hPa, the chip will still give a measurement value, such as 80 hPa, but at this time the measurement value is not accurate enough, and only the actual pressure ≤300 hPa can be qualitatively determined.

[0074] The sampling capsule 100 also includes a temperature sensor 6 located in the shell 1, with a temperature measurement range of 0°C-80°C, for detecting the temperature of the sampling capsule 100 when working, to ensure that the sampling capsule 100 works normally and does not harm the human body. When the temperature sensor 6 detects that the temperature exceeds a certain safety threshold, it needs to be stopped in time for cooling. The safety threshold is 55°C-60°C, so as not to harm the human body.

[0075] Preferably, the temperature sensor 6 is located on the second side of the partition wall 13, on the one hand, it will not pollute the sampling pool 21, and on the other hand, the elements that heat up when the sampling capsule 100 works are basically located on the second side of the partition wall 13, so that the temperature of the sampling capsule 100 can be better detected.

[0076] The temperature sensor 6 is mainly used to monitor the temperature of the sampling switch 24. According to different implementation modes of the sampling switch 24, such as shape memory micro valve, motor-based valve, etc., heat will be generated during its working process.

[0077] The control module 4 further comprises a sensor 42 for collecting physiological parameters and / or image information in the digestive tract, which is in communication connection with the microprocessor. The sensor 42 is at least one of an image sensor, or a pH sensor, or an ultrasonic sensor; when the sensor 42 comprises an image sensor, part of the shell 1 is transparent; when the sensor 42 comprises a pH sensor, the shell 1 has a window. The picture and pH value obtained by the sensor 42 are used to determine the position of the sampling capsule 100 in the digestive tract, and any method in the prior art can be used for the determination, which will not be described herein.

[0078] Of course, the control module 4, while comprising the sensor 42, can further comprise a storage module for storing normal physiological parameters or image information at different positions in the digestive tract, and physiological parameters or image information when possible lesions occur, which is in communication connection with the microprocessor. When the sensor 42 collects physiological parameters and / or image information in the digestive tract, the microprocessor compares the above information with the information in the storage module to determine whether the sampling capsule 100 reaches the position to be sampled.

[0079] Alternatively, the control module 4, while comprising the sensor 42, further comprises a wireless transmission module for being in communication connection with an external processing terminal, and when the sensor 42 collects physiological parameters and / or image information in the digestive tract, the information is transmitted to the external processing terminal, which analyzes the information to determine whether the sampling capsule 100 reaches the position to be sampled.

[0080] In addition, the control module further comprises a battery for providing power supply to other elements, and the microprocessor, the wireless transmission module and the battery are integrated on the same circuit board 41.

[0081] The use process of the sampling capsule 100 will be described in detail below.

[0082] Please refer to Figures 1 to 7 , and refer to Figure 8As shown, for example, to collect the membrane bacteria in the intestinal tract, when the capsule system reaches the designated intestinal cavity 801, the external magnet 901 can be used to approach the human body from below, so that the outer sampling port 22 is directed downward to approach the intestinal wall. Since the magnetic member is a ring-shaped radial magnetization magnet or a fan-shaped radial magnetization magnetic member distributed on one side of the outer sampling port 22, the operator can refer to the image to control the sampling capsule 100 to rotate along the axial direction of the capsule, so that one end of the outer sampling port 22 is directed toward the intestinal wall 802. However, due to the folds of the intestinal wall 802, insufficient adsorption caused by too far distance between the magnet, and other reasons, the outer sampling port 22 can not be tightly attached to the mucus layer 803; the external control device can send a "vibration" instruction to the sampling capsule 100; after receiving the instruction, the vibration motor 31 will drive the entire sampling capsule 100 to vibrate at a high frequency, especially in a direction perpendicular to the outer sampling port 22, so that the outer sampling port 22 is directed toward the intestinal wall 802; in this way, the sampling capsule 100 can be closer to the intestinal wall 802, and the mucus layer 803 and the liquid in the intestinal cavity 801 can be disturbed, so that part of the bacteria in the mucus layer 803 enters the liquid. After a period of time, the sampling capsule 100 can collect liquid containing a higher concentration of membrane bacteria by sending a sampling instruction through the external processing terminal 902. During sampling, the environment of the digestive tract on the side of the outer sampling port 22 can be determined through the image at all times, so as to ensure that the liquid on that side is full during sampling. In this way, through the combined control of the vibration motor 31, the magnetic member, and the external magnet 901, and by using the image obtained by the image sensor 42 as feedback for closed-loop control, the sampling success rate of the sampling capsule 100 and the concentration of the collected membrane bacteria can be significantly improved.

[0083] To collect a higher concentration of membrane bacteria, the sampling capsule 100 can also be used alone without relying on the external magnet, and the sampling capsule 100 can automatically complete the sampling work: when the sampling capsule 100 reaches the collection area, the vibration mode is started, the surrounding intestinal environment is disturbed, and the concentration of the membrane bacteria in the liquid in the cavity is increased. After a period of time, the vibration is stopped, and after the sampling capsule 100 is stationary, the outer sampling port 22 is directed downward to approach the intestinal wall 802 under the influence of the weight of the magnetic member, and is immersed in the liquid, and then the sampling is started, which can also achieve similar effects.

[0084] In addition, when the sampling capsule 100 is taken out of the body, the scheme for taking out the digestive fluid includes but is not limited to: the sampling switch 24 is turned on to put the communication pipe 23 in a conductive state, and the digestive fluid flows out through the communication pipe 23 and the outer sampling port 22 for pathological analysis.

[0085] Alternatively, the sampling capsule 100 further comprises an extraction assembly 7 cooperating with the sampling pool 21 to realize vacuumizing and sampling, the extraction assembly 7 comprising an extraction port 71 on the shell 1 located on the first side of the partition wall 13 and communicating with the sampling pool 21, a fixing member 72 cooperating with the extraction port 71, and a silica gel plug 73 assembled in the fixing member 72. Specifically, the fixing member 72 is fixed with the shell 1, and the silica gel plug 73 is in interference fit with the fixing member 72. Through the extraction assembly 7, a user can penetrate the silica gel plug 73 with a syringe or the like to suck the sampling pool 21 to form a vacuum or take out the sample in the sampling pool 21 to realize sampling.

[0086] It can be understood by those skilled in the art that any one of the sampling assembly 2, any one of the film bacteria collection auxiliary assembly 3, and any one of the control module 4 can cooperate to form the sampling capsule 100.

[0087] The application further provides a sampling capsule 100 system comprising any one of the above-mentioned sampling capsules 100 and an external processing terminal in communication connection with the control module 4. Specifically, the control module 4 and the external processing terminal are in communication connection in any one of the prior art, which will not be described here.

[0088] The application further provides a control method of the sampling capsule 100 based on the above-mentioned sampling capsule 100, comprising the following steps: judging whether sampling is needed, and if so, the sampling switch 24 opens the communication pipe 23; after sampling is completed, the sampling switch 24 closes the communication pipe 23. Whether sampling is needed can be judged in any one of the above-mentioned ways, which will not be described here. The sampling switch 24 opens or closes the communication pipe 23 in any one of the above-mentioned ways, which will not be described here.

[0089] In summary, the sampling capsule 100 of the present application can assist the sampling assembly 2 to take film bacteria through the film bacteria collection auxiliary assembly 3; and the sampling switch 24 opens / closes the communication pipe 23 to realize sampling, and after sampling is completed, the sampling switch 24 closes the communication pipe 23 to prevent the sample from leaking or being contaminated; and the on / off state and on / off time of the communication pipe 23 can be controlled to accurately control the sampling amount. In addition, the on / off or closure of the communication pipe 23 is actively controlled by the sampling switch 24, which is not affected by the special environment of the digestive tract site, and can be used for any digestive tract site, and has high universality.

[0090] It should be understood that although the present specification describes only a single embodiment, the disclosure of this specification includes any and all embodiments having any one of the features set forth in the specification and / or attached claims. Moreover, although individual embodiments of this specification can only disclose one independent technical solution, the specification is described in this way only for the sake of clarity, and those skilled in the art should consider the specification as a whole, and the technical solutions in each embodiment can also be appropriately combined to form other embodiments that those skilled in the art can understand.

[0091] The above detailed description of a series of specific descriptions is only for the specific description of the feasible embodiments of the present application, and is not used to limit the protection scope of the present application. Any equivalent embodiments or changes made without departing from the spirit of the present application should be included in the protection scope of the present application.

Claims

1. A sampling capsule, characterized in that: include: shell; A sampling assembly includes a sampling pool disposed in the housing, an external sampling port provided on the housing, a connecting pipe connecting the external sampling port and the sampling pool, and a sampling switch for opening or closing the connecting pipe; A membrane flora collection auxiliary component, the membrane flora collection auxiliary component includes a vibration motor disposed in the housing, or the membrane flora collection auxiliary component includes a vibration motor disposed in the housing and a counterweight disposed at the external sampling port; when the membrane flora collection auxiliary component includes a counterweight, the counterweight causes the center of gravity of the sampling capsule to deviate toward the external sampling port; when the membrane flora collection auxiliary component includes a vibration motor, the vibration motor is a linear vibration motor, and the vibration direction of the linear vibration motor is adjusted to be perpendicular to the external sampling port and is located at the center of the sampling capsule; The control module includes a microprocessor that is communicatively connected to the sampling switch and the vibration motor.

2. The sampling capsule according to claim 1, characterized in that: The sampling component comprises a plurality of external sampling ports opened on the shell, a sampling cavity communicated with the plurality of external sampling ports, and the communicating pipe is communicated with the sampling cavity.

3. The sampling capsule according to claim 2, characterized in that: The plurality of external sampling ports are distributed at intervals along the circumference of the sampling capsule.

4. The sampling capsule according to claim 2, characterized in that: The aperture of each of the external sampling ports is smaller than the aperture of the connecting tube.

5. The sampling capsule according to claim 2, characterized in that: A filtering structure is provided in the sampling cavity.

6. The sampling capsule according to claim 1, characterized in that: The counterweight is a magnetic component, and the center of gravity of the magnetic component is biased toward a side of the magnetic component close to the housing.

7. The sampling capsule according to claim 6, characterized in that: One side of the magnetic component is an arc surface matched with the shell, and the magnetic component is a radially magnetized magnetic component.

8. The sampling capsule according to claim 6, characterized in that: The magnetic member and the external sampling port are arranged side by side along the axial direction of the sampling capsule.

9. The sampling capsule according to claim 1, characterized in that: The sampling capsule further includes an extraction component, which includes an extraction port located on the shell and communicated with the sampling pool, a fixing member matched with the extraction port, and a silicone plug assembled in the fixing member.

10. The sampling capsule according to any one of claims 1 to 9, characterized in that: The control module further comprises a sensor for collecting physiological parameters and / or image information in the digestive tract, wherein the sensor is communicatively connected to the microprocessor; Alternatively, the control module further includes a sensor for collecting physiological parameters and / or image information in the digestive tract, and a storage module for storing normal physiological parameters or image information of different parts of the digestive tract, as well as physiological parameters or image information of possible pathological conditions, and both the sensor and the storage module are communicatively connected to the microprocessor; Or the control module further includes a sensor for collecting physiological parameters and / or image information in the digestive tract, a wireless transmission module for communicating with an external processing terminal, and the sensor is communicatively connected to the microprocessor.

11. The sampling capsule according to claim 10, characterized in that: The sensor is at least one of an image sensor, a pH sensor, and an ultrasonic sensor; when the sensor includes an image sensor, part of the housing is transparent; when the sensor includes a pH sensor, the housing has a window.

12. A sampling capsule system, comprising the sampling capsule according to any one of claims 1 to 11, and an external processing terminal communicatively connected to a control module.

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