Biopsy assembly, ultrasonic micro probe, ultrasonic endoscope and biopsy sampling system

Abstract

The invention provides a biopsy assembly, an ultrasonic micro probe, an ultrasonic endoscope and a biopsy sampling system.The biopsy assembly comprises a cap body and a sampling piece, the cap body is provided with a first opening and a second opening, the first opening and the second opening are arranged in a staggered mode, the cap body is internally provided with a containing cavity and a pressure adjusting cavity, the containing cavity is communicated with the first opening, and the pressure adjusting cavity is communicated with the pressure adjusting cavity. The pressure adjusting cavity channel is communicated with the second opening and the storage cavity channel so as to provide positive pressure or negative pressure into the storage cavity channel; the sampling piece is at least partially arranged in the accommodating cavity channel and can move between a first position and a second position relative to the first opening; when the positive pressure in the containing cavity exceeds a first threshold value, the sampling piece moves from the first position to the second position relative to the first opening, so that at least part of the sampling piece penetrates through the first opening and extends out of the cap body. According to the invention, the biopsy assembly and the intracavity detection device can be inserted into a cavity or an instrument channel at the same time after being matched, so that the sampling is prevented from deviating from the actual position, and the sampling accuracy is improved.

Description

Technical Field

[0001] The present invention relates to the technical field of medical instruments, and in particular to a biopsy component, an ultrasonic microprobe, an ultrasonic endoscope and a biopsy sampling system.

[0002] Biopsy (live tissue examination) is an important diagnostic method in medicine. It obtains diseased tissue or cell samples from the patient's body and performs pathological examination to clarify the nature, type, stage and other information of the disease, providing key basis for clinical diagnosis and treatment. The sampling methods of biopsy include: incisional biopsy, forceps biopsy, puncture biopsy and brush biopsy, etc. Biopsy requires the use of sampling instruments. For example, the main sampling instrument in puncture biopsy is the puncture needle, and the main sampling instrument in brush biopsy is the cell brush. Sampling instruments such as puncture needles and cell brushes are important in clinical emergency treatment and respiratory interventional treatment.

[0003] Current sampling instruments, such as puncture needles, mostly include a sheath, a needle, and a drive shaft. When the puncture needle is inserted into the patient's body to reach the puncture position where the diseased tissue or cell sample needs to be obtained, the puncture needle is stored in the sheath. When the puncture needle reaches the puncture position, the operator pushes the piston at the proximal end to drive the needle out of the sheath with the drive shaft. After aligning the puncture needle with the puncture position and puncturing, the operator extracts the piston at the proximal end again to achieve sample collection. Most cell brushes include a brush head and a catheter, etc. The brush head is controlled by the catheter to move to the sampling area to obtain diseased tissue or cell samples.

[0004] Sampling instruments often need to be used in conjunction with intracavitary detection devices, for example, ultrasonic microprobes, etc. However, due to the limited space in the cavity or instrument channel, most of the existing intracavitary detection devices and sampling instruments cannot be inserted into the cavity or instrument channel at the same time. Instead, the intracavitary detection device is withdrawn after completing the imaging, and then the sampling instrument is sent in for biopsy. However, as time goes by and the user coughs or changes in body position, the original intracavitary detection position may move when the sampling instrument is sent in for sampling, causing the sampling to deviate from the actual position. Summary of the invention

[0005] In order to at least partially solve the problems existing in the prior art, according to one aspect of the present invention, a biopsy component is provided, and the technical solution is as follows.

[0006] The biopsy assembly includes a cap body and a sampling piece. The cap body is provided with a first opening and a second opening, and the first opening and the second opening are staggered. The cap body is provided with a receiving cavity and a pressure regulating cavity, and the receiving cavity is connected with the first opening, and the pressure regulating cavity is connected with the second opening and the receiving cavity to provide positive pressure or negative pressure in the receiving cavity; the sampling piece is at least partially arranged in the receiving cavity, and is movable between a first position and a second position relative to the first opening; wherein, when the positive pressure in the receiving cavity exceeds a first threshold value, the sampling piece moves from the first position to the second position relative to the first opening, so as to at least partially pass through the first opening and extend out of the cap body.

[0007] According to the biopsy component of the present invention, when the operator sends the biopsy component into the patient's body and reaches the sampling area, the sampling piece is stored in the storage cavity to avoid scratching other parts of the patient's body; after reaching the sampling area, gas (such as air) or liquid (such as saline) can be injected into the pressure regulating cavity to provide positive pressure to the storage cavity. When the positive pressure in the storage cavity exceeds a first threshold, the sampling piece is extended out of the storage cavity to facilitate the biopsy operation; in this way, based on the cap body with an opening, a storage cavity and a pressure regulating cavity, it is beneficial for the biopsy component to be inserted into the cavity or the instrument channel at the same time after cooperation with the intracavity detection device, thereby avoiding the sampling from deviating from the actual position and improving the accuracy of the sampling.

[0008] Exemplarily, the sampling member includes a sampling needle and a piston, the piston is slidably disposed in the receiving cavity, the sampling needle is disposed on the piston, and when the piston is located at the second position, the needle tip of the sampling needle extends out of the cap body.

[0009] Exemplarily, when the negative pressure in the receiving cavity exceeds a second threshold, the sampling needle absorbs the object to be tested.

[0010] Exemplarily, the piston includes a first plug body and a second plug body, the first plug body has an inner cavity, the first plug body has a first port and a second port respectively formed at both ends of the inner cavity, the first port is opposite to the first opening, and the needle tail of the sampling needle is arranged at the first port; a part of the second plug body is located in the inner cavity, and is movable between a third position and a fourth position relative to the first plug body; when the second plug body is in the third position, the second port is opened, and the inner cavity is connected to the pressure regulating cavity; when the second plug body is in the fourth position, the second port is closed.

[0011] Exemplarily, the inner cavity has a first cavity and a second cavity, the first cavity is farther away from the first port than the second cavity, the cross-sectional area of ​​the first cavity is smaller than the cross-sectional area of ​​the second cavity, and a portion of the second plug body passes through the first cavity and extends into the second cavity.

[0012] Exemplarily, the second plug body includes a plate-like body, the area of ​​the plate-like body is larger than the area of ​​the second port, and when the second plug body is in the fourth position, the plate-like body abuts against the end surface of the first plug body away from the first opening to close the second port.

[0013] Exemplarily, the second plug body includes a plurality of penetrating bodies, each of which has a leg and a foot, wherein the first end of the leg is connected to the plate-like body, the second end of the leg is connected to the foot, the foot passes through the first cavity and extends into the second cavity, and there is a gap between the leg and the cavity wall of the first cavity.

[0014] Exemplarily, the sampling member includes a cell brush and a piston, the piston is slidably disposed in the receiving cavity, the cell brush is disposed on the piston, and when the piston is located at the second position, the brush head of the cell brush at least partially extends out of the cap body.

[0015] Exemplarily, the piston includes a first plug body and a second plug body, the first plug body has an inner cavity, the first plug body has a first port and a second port respectively formed at both ends of the inner cavity, the first port is opposite to the first opening, and the tail of the cell brush is arranged at the first port; a portion of the second plug body is located in the inner cavity and closes the second port.

[0016] Exemplarily, an elastic claw is disposed on the first plug body, and the elastic claw is configured to be in a closed state when the sampling member is located at the first position, and to be in an open state when the sampling member is located at the second position.

[0017] Exemplarily, the receiving cavity has a first cavity section and a second cavity section, the first cavity section is farther away from the first opening than the second cavity section, and the cross-sectional area of ​​at least part of the second cavity section is larger than the cross-sectional area of ​​the first cavity section. When the sampling piece is in the first position, the elastic claw is located in the first cavity section, and when the sampling piece is in the second position, the elastic claw is located in the second cavity section.

[0018] Exemplarily, a positioning step is formed at the connection between the first cavity segment and the second cavity segment, and the elastic claw in the opened state abuts against the positioning step.

[0019] Exemplarily, the elastic claw includes at least two spring leaves, and the at least two spring leaves are arranged at intervals along the outer circumference of the first plug body.

[0020] Exemplarily, the receiving cavity has a length L1, the sampling piece has a length L2, and L1 ≥ L2.

[0021] Exemplarily, the pressure regulating cavity has a diameter D, and the diameter D is ≤ 0.5 mm.

[0022] Exemplarily, the cap body has a large end and a small end, and the cap body gradually decreases from the large end to the small end.

[0023] Exemplarily, the sampling member and the first opening are both arranged on the central axis of the cap body, and the first opening is located on the small end.

[0024] Exemplarily, there is a first angle between the sampling member and the central axis of the cap body, and the first angle is 0° to 180°.

[0025] Exemplarily, there is a second angle between the central axis of the receiving cavity and the central axis of the cap body, and the second angle is 0° to 60°.

[0026] Exemplarily, the cross-section of the receiving cavity is circular.

[0027] According to another aspect of the present invention, an ultrasonic microprobe is provided, which includes a probe body, an ultrasonic transducer and the above-mentioned biopsy component, wherein the biopsy component is arranged on the distal end of the probe body, and the ultrasonic transducer is arranged in the probe body, wherein the ultrasonic transducer has an emitting surface, the emitting surface emits ultrasonic waves to form an ultrasonic imaging area, and the biopsy component is located in the ultrasonic imaging area.

[0028] Exemplarily, the biopsy component is detachably connected to the probe body.

[0029] Exemplarily, a fixing portion is disposed at one end of the cap body away from the first opening, a fixing matching portion is disposed on the distal end of the probe body, and the fixing portion is connected to the fixing matching portion.

[0030] Exemplarily, the fixing portion is threadedly connected to the fixing matching portion.

[0031] Exemplarily, the emitting surface and the central axis of the probe body have an included angle α, and the included angle α is 0° to 90°.

[0032] Exemplarily, the ultrasonic transducer is rotatable around the central axis of the probe body or retractable along the central axis of the probe body.

[0033] According to another aspect of the present invention, an ultrasonic endoscope is provided, which includes a host, an endoscope body and the above-mentioned ultrasonic microprobe, the endoscope body has a clamp channel, the ultrasonic microprobe at least partially passes through the clamp channel to enter the cavity to be inspected, and the ultrasonic microprobe is electrically connected to the host.

[0034] According to another aspect of the present invention, a biopsy sampling system is provided, comprising a host and an ultrasonic microprobe as described above, wherein the host is electrically connected to the ultrasonic microprobe and implements the following steps: acquiring an image to be inspected through an ultrasonic transducer, and determining a target sampling area based on the image to be inspected; determining an initial position of a sampling piece in the image to be inspected; predicting a moving path of the sampling piece from the initial position to the target sampling area, and controlling the sampling piece to move from the initial position to the target sampling area along the moving path; and when the sampling piece moves to the target sampling area, using the sampling piece to perform biopsy sampling on the target sampling area.

[0035] The above-mentioned ultrasonic microprobe, ultrasonic endoscope and biopsy sampling system have the corresponding beneficial effects of the above-mentioned biopsy component.

[0036] A series of simplified concepts are introduced in the summary of the invention, which will be further described in detail in the detailed description. The summary of the invention does not mean to attempt to define the key features and essential technical features of the claimed technical solution, nor does it mean to attempt to determine the scope of protection of the claimed technical solution.

[0037] The advantages and features of the present invention are described in detail below with reference to the accompanying drawings. BRIEF DESCRIPTION OF THE DRAWINGS

[0038] The following drawings of the present invention are used as part of the present invention for understanding the present invention. The drawings show the embodiments of the present invention and their descriptions, and are used to explain the principles of the present invention. In the drawings,

[0039] Figure 1 A perspective view of a biopsy assembly according to an exemplary embodiment of the present invention;

[0040] Figure 2 for Figure 1 A cross-sectional view of the biopsy assembly shown (with the sampling member in a first position);

[0041] Figure 3 for Figure 1 A cross-sectional view of the biopsy assembly shown (with the sampling member in a second position);

[0042] Figure 4 for Figure 3 Enlarged view of part A in the middle;

[0043] Figure 5 for Figure 2 and Figure 3 A three-dimensional view of the second plug body;

[0044] Figure 6 A cross-sectional view of a biopsy assembly according to another exemplary embodiment of the present invention (the sampling member is in a first position);

[0045] Figure 7 A cross-sectional view of a biopsy assembly according to another exemplary embodiment of the present invention (the sampling member is in a second position);

[0046] Figure 8 A perspective view of a portion of an ultrasonic microprobe according to an exemplary embodiment of the present invention;

[0047] Fig. 9 for Figure 8 A cross-sectional view of a portion of the ultrasonic microprobe is shown.

[0048] The above drawings include the following reference numerals:

[0049] 10. Biopsy assembly; 100. Cap; 110. First opening; 120. Second opening; 130. Accommodating cavity; 131. First cavity section; 132. Second cavity section; 1321. First step cavity section; 1322. Second step cavity section; 1323. Step surface; 133. Third cavity section; 134. Positioning step; 140. Pressure regulating cavity; 150. Large end; 160. Small end; 170. Fixing part; 200. Sampling piece; 210. Sampling needle; 211. Pressure flow channel; 220. Piston ; 221, first plug body; 2211, inner cavity; 2211a, first cavity; 2211b, second cavity; 2212, first port; 2213, second port; 222, second plug body; 2221, plate-like body; 2222, penetrating body; 2222a, leg; 2222b, foot; 223, elastic claw; 230, cell brush; 231, bristles; 232, brush rod; 30, probe body; 301, fixed fitting part; 40, ultrasonic transducer; 401, emitting surface; 50, drive shaft. DETAILED DESCRIPTION

[0050] In the following description, a large amount of details are provided so that the present invention can be thoroughly understood. However, it will be appreciated by those skilled in the art that the following description only exemplarily illustrates a preferred embodiment of the present invention, and the present invention can be implemented without one or more such details. In addition, in order to avoid confusion with the present invention, some technical features well known in the art are not described in detail.

[0051] In order to fully understand the embodiments of the present invention, detailed structures will be presented in the following description. Obviously, the implementation of the embodiments of the present invention is not limited to the specific details familiar to those skilled in the art. The preferred embodiments of the present invention are described in detail below, but in addition to these detailed descriptions, the present invention may also have other embodiments.

[0052] An embodiment of the present invention provides a biopsy assembly. The biopsy assembly of the present invention can be installed on an interventional device, and the host connected to the interventional device can perform a biopsy sampling method. A biopsy assembly according to an embodiment of the present invention will be described in detail below in conjunction with the accompanying drawings.

[0053] Combined with reference Figures 1 to 3, the biopsy assembly 10 may include a cap body 100 and a sampling member 200. A first opening 110 and a second opening 120 may be provided on the cap body 100. The first opening 110 and the second opening 120 are arranged in a staggered manner. A receiving cavity 130 and a pressure regulating cavity 140 may be provided in the cap body 100. The receiving cavity 130 may be communicated with the first opening 110. The pressure regulating cavity 140 may communicate the second opening 120 with the receiving cavity 130 to provide positive pressure or negative pressure in the receiving cavity 130. In other words, the first opening 110, the receiving cavity 130, the pressure regulating cavity 140 and the second opening 120 may be communicated in sequence. Specifically, an external pipeline can be connected to the second opening 120, and the external pipeline can be connected to the pressure regulating cavity 140. The end of the external pipeline away from the second opening 120 can be connected to a joint and located outside the patient's body, so that the external pipeline can be connected to a syringe, a pump or other equipment to provide positive pressure or negative pressure to the pressure regulating cavity 140. Of course, the external pipeline can also pass through the second opening 120 and extend into the pressure regulating cavity 140, thereby ensuring the stability of the connection between the external pipeline and the cap body 100 and enhancing the sealing. The material of the external pipeline can be selected from a material with good toughness, and a material with good toughness can better adapt to the operation requirements such as bending and twisting.

[0054] For example, the first opening 110 and the second opening 120 may be staggered in the axial direction and / or radial direction so that the connecting line of the first opening 110 and the second opening 120 forms a certain angle with the central axis of the cap body 100. Figure 2 As shown, the arrangement of the first opening 110 and the second opening 120 allows the receiving cavity 130 and the pressure regulating cavity 140 to occupy only a portion of the central area of ​​the axis, and the remaining area can form an escape space for other components, thereby making the overall structure more compact and smaller in size.

[0055] The sampling member 200 may be at least partially disposed in the receiving cavity 130 and in a first position (eg, Figure 2 ) and the second position (such as Figure 3 When the positive pressure in the receiving cavity 130 exceeds the first threshold, the sampling member 200 can move from the first position to the second position relative to the first opening 110 to at least partially pass through the first opening 110 and extend outside the cap body 100.

[0056] In the process of the operator delivering the biopsy component 10 into the patient's body and reaching the sampling area, the sampling piece 200 is stored in the storage cavity 130 to avoid scratching other parts of the patient's body; after reaching the sampling area, gas (such as air) or liquid (such as saline) can be injected into the pressure regulating cavity 140 to provide positive pressure to the storage cavity 130. When the positive pressure in the storage cavity 130 exceeds the first threshold, the sampling piece 200 is extended out of the storage cavity 130 to facilitate the biopsy operation; in this way, based on the cap body 100 with the opening, the storage cavity 130 and the pressure regulating cavity 140, it is beneficial for the biopsy component 10 to be inserted into the cavity or instrument channel at the same time after cooperating with the intracavity detection device, thereby avoiding the sampling from deviating from the actual position and improving the accuracy of the sampling.

[0057] Exemplarily, the biopsy component 10 can be arranged in conjunction with an intracavity detection device to obtain an intracavity detection biopsy device. Furthermore, the first opening 110 and the second opening 120 are arranged in a staggered manner, so that the storage cavity 130 and the pressure regulating cavity 140 of the biopsy component 10 part will not occupy the entire axial center area of ​​the intracavity detection biopsy device, but can form an escape space for the intracavity detection device through such a staggered arrangement. The intracavity detection device and the biopsy component 10 can be respectively arranged at different positions in the axial direction, that is, there is no need to respectively set the biopsy component channel and the intracavity detection device channel in the axial direction, so that the biopsy component 10 and the intracavity detection device can be arranged as compactly as possible, thereby reducing the radial size of the intracavity detection biopsy device, so that the intracavity detection biopsy device can be smoothly inserted into the cavity or instrument channel.

[0058] See also Figure 2 and Figure 3 The sampling member 200 may include a sampling needle 210 and a piston 220. The piston 220 may be slidably disposed in the receiving cavity 130. The sampling needle 210 may be disposed on the piston 220. When the piston 220 is located at the second position, the needle tip of the sampling needle 210 may extend outside the cap body 100. By driving the sampling needle 210 to move through the piston 220, not only is it possible to drive the sampling needle 210 through pressure, but also the stability of the sampling needle 210 when moving is improved.

[0059] When the negative pressure in the receiving cavity 130 exceeds the second threshold, the sampling needle 210 can absorb the object to be tested. Understandably, the object to be tested may include diseased tissue or cell samples, etc. After the sampling needle 210 is extended and before the formal puncture is performed, all the gas or liquid used to provide positive pressure is extracted; after the sampling needle 210 is aligned with the puncture position and punctured, the pressure regulating cavity 140 can be sucked to provide negative pressure to the receiving cavity 130. When the negative pressure in the receiving cavity 130 exceeds the second threshold, the sampling needle 210 absorbs the object to be tested to achieve sample collection. Specifically, the sampling needle 210 can be provided with a pressure flow channel 211 inside. When the negative pressure in the receiving cavity 130 exceeds the second threshold, the negative pressure can be transmitted to the needle tip through the pressure flow channel 211 to absorb the object to be tested to achieve sample collection. The type of the sampling needle 210 can be a suction type. The diameter of the sampling needle 210 can be less than 0.7mm. In this way, by adjusting the pressure with the help of the pressure regulating cavity 140 to complete the sampling operation of the sampling needle 210, the volume of the entire biopsy component 10 is relatively small, so that the biopsy component 10 can be inserted into the cavity or instrument channel at the same time after cooperating with the intracavitary detection device, thereby avoiding the sampling from deviating from the actual position and improving the accuracy of the sampling.

[0060] Combined with reference Figures 2 to 4 , the piston 220 may include a first plug body 221 and a second plug body 222. The first plug body 221 may have an inner cavity 2211. The first plug body 221 may be formed with a first port 2212 and a second port 2213 at both ends of the inner cavity 2211, respectively. The first port 2212 may be opposite to the first opening 110. The needle tail of the sampling needle 210 may be arranged at the first port 2212, and the pressure flow channel 211 of the sampling needle 210 is connected to the inner cavity 2211. A portion of the second plug body 222 may be located in the inner cavity 2211, and may be movable between a third position and a fourth position relative to the first plug body 221. When the second plug body 222 is in the third position, the second port 2213 may be opened, and the inner cavity 2211 may be connected to the pressure regulating cavity 140. When the second plug body 222 is in the fourth position, the second port 2213 may be closed (such as Figure 3 , at this time, the second plug body 222 is in the fourth position). The second plug body 222 and the sampling needle 210 can be connected in any suitable manner such as pasting, snap connection or threaded connection, which is not limited here.

[0061] Taking a biopsy of a patient's respiratory tract as an example, if a large amount of gas or liquid enters the bronchus, it will cause the patient to choke and cough, which may cause the sampling needle 210 to scratch the patient. The biopsy assembly 10 provided in the present invention injects gas or liquid into the pressure regulating cavity 140 to provide positive pressure in the receiving cavity 130. When the positive pressure in the receiving cavity 130 exceeds the first threshold, the second plug body 222 is in the fourth position to close the second port 2213, thereby preventing a large amount of gas or liquid in the receiving cavity 130 from flowing into the patient's body and causing irritation to the patient, thereby improving safety. After the sampling needle 210 extends out of the receiving cavity 130 and before it formally enters the puncture, all the gas and liquid used to provide positive pressure are extracted; after the sampling needle 210 is aligned with the puncture position and punctures, the pressure regulating cavity 140 can be sucked to provide negative pressure to the receiving cavity 130. When the negative pressure in the receiving cavity 130 exceeds the second threshold, the second plug 222 is in the third position to open the second port 2213, and the negative pressure is smoothly transmitted to the sampling needle 210, so that the sampling needle 210 absorbs the object to be tested. In this way, it is ensured that the biopsy assembly 10 can successfully complete the sampling operation and improve safety.

[0062] See again Figure 4 , the inner cavity 2211 may have a first cavity 2211a and a second cavity 2211b. The first cavity 2211a may be farther away from the first port 2212 than the second cavity 2211b. The cross-sectional area of ​​the first cavity 2211a may be smaller than the cross-sectional area of ​​the second cavity 2211b. A portion of the second plug body 222 may extend through the first cavity 2211a into the second cavity 2211b. The first cavity 2211a and the second cavity 2211b cooperate with the second plug body 222 to limit the portion of the second plug body 222 extending into the second cavity 2211b in the second cavity 2211b, thereby preventing the second plug body 222 from falling off from the first plug body 221.

[0063] Combined with reference Figure 4 and Figure 5 , the second plug body 222 may include a plate-shaped body 2221. The area of ​​the plate-shaped body 2221 may be greater than the area of ​​the second port 2213. When the second plug body 222 is in the fourth position, the plate-shaped body 2221 may abut against the end surface of the first plug body 221 away from the first opening 110 to close the second port 2213. This not only prevents a large amount of gas or liquid in the receiving cavity 130 from entering the patient's airway to cause irritation to the patient, reduces safety risks, but is also easy to implement, has a simple structure, and reduces costs.

[0064] Again, refer to Figure 4 and Figure 5, the second plug body 222 may include a plurality of penetration bodies 2222. The penetration body 2222 may have a leg 2222a and a foot 2222b. The first end of the leg 2222a may be connected to the plate-like body 2221. The second end of the leg 2222a may be connected to the foot 2222b. The foot 2222b may pass through the first cavity 2211a and extend into the second cavity 2211b. A limiting step may be formed at the connection between the second cavity 2211b and the first cavity 2211a. When the second plug body 222 is located at the third position, the foot 2222b may abut against the limiting step, effectively preventing the second plug body 222 from falling off the first plug body 221. There may be a gap between the leg 2222a and the cavity wall of the first cavity 2211a. When the pressure regulating cavity 140 is sucked to provide negative pressure to the receiving cavity 130 , it is ensured that the airflow will not be blocked by the second plug body 222 , and the negative pressure can be smoothly transmitted to the sampling needle 210 .

[0065] In some embodiments, a plurality of penetration bodies 2222 may be circumferentially spaced apart on a surface of the plate-like body 2221 opposite to the second port 2213. An equidistant gap may be provided between each two penetration bodies 2222. When the pressure regulating cavity 140 is suctioned to provide negative pressure to the receiving cavity 130, it is further ensured that the air will not be blocked by the second plug body 222, and the negative pressure can be smoothly transferred to the sampling needle 210. Preferably, there may be four penetration bodies 2222, which effectively prevents the second plug body 222 from falling off the first plug body 221, and is also easy to manufacture. Of course, it is not excluded that the penetration bodies 2222 may be three, five, etc. The foot 2222b may be further away from the central axis of the second plug body 222 than the leg 2222a, which not only reduces the air blocking of the foot 2222b, but also effectively prevents the second plug body 222 from falling off the first plug body 221.

[0066] In some embodiments, the second plug body 222 may include a penetration body 2222. The penetration body 2222 may have a leg 2222a and at least one foot 2222b. One end of the leg 2222a may be connected to the plate-like body 2221. Specifically, the leg 2222a may be connected to the middle of a side of the plate-like body 2221 opposite to the second port 2213 to ensure the stability of the connection between the leg 2222a and the plate-like body 2221. The other end of the leg 2222a may be connected to the foot 2222b. The leg 2222a may be connected to the middle of the foot 2222b. When the second plug body 222 is located in the third position, the foot 2222b blocks a portion of the first cavity 2211a, and another portion of the first cavity 2211a is connected to the second cavity 2211b. In other words, the shape of the second plug body 222 may be an "I" shape. When there are multiple feet 2222b, the middle part of each foot 2222b can be connected to the leg 2222a and rotated around the leg 2222a, and there can be gaps between the feet 2222b. This not only ensures the stability of the connection between the leg 2222a and the foot 2222b, but also ensures that the air will not be completely blocked by the second plug body 222. Of course, in addition to the above structure, the second plug body 222 may also be any suitable structure to ensure that when the second plug body 222 is in the third position, it will not be separated from the first plug body 221, and when the second plug body 222 is in the fourth position, the second port 2213 can be closed.

[0067] Combined with reference Figure 6 and Figure 7 , the sampling part 200 may include a cell brush 230 and a piston 220. Specifically, the cell brush 230 may include bristles 231 and a brush rod 232. The number of bristles 231 may be multiple. Multiple bristles 231 may extend 360° perpendicular to the axial direction of the brush rod 232. The connection method between the bristles 231 and the brush rod 232 may be any suitable method such as pasting, snapping, etc., which is not limited here. The bristles 231 may be made of hard material so that the bristles 231 can more easily take the object to be tested. Perpendicular to the axial direction of the brush rod 232, the bristles 231 may have a length, which may be about 1 mm. Along the axial direction of the brush rod 232, the multiple bristles 231 may occupy a length of about 8 mm of the brush rod 232. The piston 220 may be slidably disposed in the receiving cavity 130. The cell brush 230 may be disposed on the piston 220. When the piston 220 is located in the second position, the brush head of the cell brush 230 may extend outside the cap body 100. The piston 220 drives the cell brush 230 to move, which not only realizes driving the cell brush 230 by pressure, but also improves the stability of the cell brush 230 when moving.

[0068] Exemplarily, the piston 220 may include a first plug body 221 and a second plug body 222. The first plug body 221 may have an inner cavity 2211. The first plug body 221 may be formed with a first port 2212 and a second port 2213 at both ends of the inner cavity 2211. The first port 2212 may be opposite to the first opening 110. The tail of the cell brush 230 may be arranged at the first port 2212, and a part of the second plug body 222 may be located in the inner cavity 2211, and the second port 2213 may be closed. The connection method between the second plug body 222 and the cell brush 230 may be any suitable method such as pasting, snap connection or threaded connection, which is not limited here. The second plug body 222 may be of any suitable shape, and the connection method between the second plug body 222 and the first plug body 221 may be any suitable method such as pasting, snap connection or threaded connection, as long as the second plug body 222 closes the second port 2213.

[0069] Taking a biopsy of a patient's respiratory tract as an example, if a large amount of gas or liquid enters the bronchus, it will cause the patient to choke and cough, causing the cell brush 230 to mistakenly take the object to be tested in other parts of the body, thereby affecting the accuracy of the test results. The biopsy component 10 provided in the present invention injects gas or liquid into the pressure regulating cavity 140 to provide positive pressure to the receiving cavity 130. When the positive pressure in the receiving cavity 130 exceeds the first threshold, the second plug body 222 closes the second port 2213, thereby preventing a large amount of gas or liquid in the receiving cavity 130 from flowing into the patient's body and causing irritation to the patient, thereby affecting the accuracy of the test results. After the cell brush 230 extends out of the receiving cavity 130, the object to be tested is taken by rotating the cell brush 230. In this way, it is ensured that the biopsy component 10 can successfully complete the sampling operation and improve the accuracy of the test results.

[0070] In an embodiment not shown in the figure, the sampling member 200 may include a piston 220 and any other suitable sampling tools, so that the sampling tools can be driven by the piston 220 to move from the receiving cavity 130 to the outside of the cap body 100. In this way, according to the needs of sampling in different sampling areas, a suitable sampling member 200 can be selected, so that the biopsy assembly 10 can be applied to different scenarios.

[0071] Combined with reference Figure 2 and Figure 4 The first plug body 221 may be provided with an elastic claw 223. The elastic claw 223 may be configured to be in a closed state (eg, Figure 2 ), when the sampling member 200 is in the second position, it is in an open state (such as Figure 4). The connection method between the elastic claw 223 and the first plug body 221 can be any suitable method such as pasting, snap connection, etc., which is not limited here. Understandably, the closed state may refer to the surface of the elastic claw 223 being attached to the surface of the first plug body 221 or the surface of the elastic claw 223 and the surface of the first plug body 221 forming a small angle that is not easy to observe. The open state may refer to the surface of the elastic claw 223 and the surface of the first plug body 221 forming a certain angle. When the elastic claw 223 is in the closed state, it is convenient for the piston 220 to drive the sampling needle 210 or the cell brush 230 to move. When the elastic claw 223 is in the open state, it is convenient to limit the sampling needle 210 or the cell brush 230, and provide sufficient support force for the sampling needle 210 or the cell brush 230, thereby ensuring that the sampling needle 210 or the cell brush 230 can successfully perform sampling.

[0072] Again, refer to Figures 2 to 4, the receiving cavity 130 may have a first cavity section 131 and a second cavity section 132. The first cavity section 131 may be farther away from the first opening 110 than the second cavity section 132. The cross-sectional area of ​​at least part of the second cavity section 132 may be greater than the cross-sectional area of ​​the first cavity section 131. In some embodiments, when the second cavity section 132 is cylindrical, the cross-sectional area of ​​the entire second cavity section 132 may be greater than the cross-sectional area of ​​the first cavity section 131. When the second cavity section 132 is truncated cone-shaped, the cross-sectional area of ​​the second cavity section 132 near the first cavity section 131 may be greater than the cross-sectional area of ​​the first cavity section 131, and the cross-sectional area of ​​the second cavity section 132 away from the first cavity section 131 may be equal to or slightly greater than the cross-sectional area of ​​the first cavity section 131. The cross-sectional area of ​​the first cavity section 131 may be slightly greater than the cross-sectional area of ​​the piston 220, so that the piston 220 can slide in the first cavity section 131. When the sampling member 200 is in the first position, the elastic claw 223 can be located in the first cavity section 131. Since the cross-sectional area of ​​the first cavity section 131 is only slightly larger than the cross-sectional area of ​​the piston 220, the elastic claw 223 is in a closed state under the squeezing effect of the inner wall of the first cavity section 131. When the sampling member 200 is in the second position, the elastic claw 223 can be located in the second cavity section 132. Since the cross-sectional area of ​​the second cavity section 132 is larger, the elastic claw 223 is released after entering the second cavity section 132, and the elastic claw 223 can be in an open state. On the one hand, by setting two chamber sections with different cross-sectional areas, the closing and opening switching of the elastic claw 223 is realized, which is not only simple in structure but also convenient for switching; on the other hand, when the elastic claw 223 is in the closed state, the first chamber section 131 can also guide the piston 220 to drive the sampling needle 210 or the cell brush 230 to move, and when the elastic claw 223 is in the open state, the elastic claw 223 limits the piston 220 to the second chamber section 132, providing sufficient support force for the sampling needle 210 or the cell brush 230, thereby ensuring that the sampling needle 210 or the cell brush 230 can successfully perform sampling. It should be noted that when the sampling needle 210 is used for sampling, when the negative pressure in the first chamber section 131 exceeds the second threshold value, the sampling needle 210 can absorb the object to be tested.

[0073] Again, refer to Figures 2 to 4 The connection between the first cavity section 131 and the second cavity section 132 may form a positioning step 134, and the elastic claw 223 in the open state may abut against the positioning step 134. When the gas or liquid in the receiving cavity 130 for providing positive pressure is extracted, or when the pressure regulating cavity 140 is sucked to provide negative pressure to the receiving cavity 130, the elastic claw 223 in the open state cooperates with the positioning step 134 to effectively prevent the sampling needle 210 or the cell brush 230 from returning from the second position to the first position, thereby ensuring that the sampling operation is not affected.

[0074] Specifically, along the axial direction of the sampling member 200, the length of the second cavity section 132 can be greater than or equal to the length of the piston 220, thereby ensuring that the piston 220 can be located in the second cavity section 132 when in the second position, and the elastic claw 223 can be in an open state, further effectively preventing the sampling needle 210 or the cell brush 230 from returning to the first position from the second position, thereby ensuring that the sampling operation is not affected.

[0075] The second cavity section 132 may include a first step cavity section 1321 and a second step cavity section 1322. One end of the first step cavity section 1321 may be connected to the first cavity section 131, and the cross-sectional area of ​​the first step cavity section 1321 may be greater than the cross-sectional area of ​​the first cavity section 131. The other end of the first step cavity section 1321 may be connected to the second step cavity section 1322 through a step surface 1323, and the cross-sectional area of ​​the second step cavity section 1322 may be equal to the cross-sectional area of ​​the piston 220. In this way, when the piston 220 is in the second position and is located in the second cavity section 132, it is ensured that the elastic claw 223 can be in an open state in the first step cavity section 1321, thereby blocking the sampling needle 210 or the cell brush 230 from returning to the first position from the second position. The piston 220 is limited in the radial direction by the second step cavity section 1322. When sampling, the sampling needle 210 or the cell brush 230 is prevented from shaking in the radial direction to ensure that the sampling operation is not affected.

[0076] Exemplarily, the area of ​​the first opening 110 may be smaller than the cross-sectional area of ​​the piston 220. The second cavity section 132 may be connected to the first opening 110. When the piston 220 is located in the second position, the piston 220 may abut against the inner wall of the second cavity section 132 near the first opening 110. Of course, the area of ​​the first opening 110 may also be equal to or greater than the second cavity section 132. A plug having a through hole may be connected at the first opening 110. The area of ​​the through hole may be smaller than the cross-sectional area of ​​the piston 220. When the piston 220 is located in the second position, the piston 220 may abut against one side of the plug located in the receiving cavity 130. In this way, the situation where the piston 220 is separated from the cap body 100 when moving from the first position to the second position is avoided.

[0077] In some embodiments, refer again to Figure 2 and Figure 3, the receiving cavity 130 may also have a third cavity section 133. The third cavity section 133 may be connected to the second cavity section 132 and the first opening 110. The cross-sectional area of ​​the third cavity section 133 may be smaller than the cross-sectional area of ​​the first cavity section 131. The cross-sectional area of ​​the third cavity section 133 may be smaller than the cross-sectional area of ​​the piston 220. A step surface may be formed at the connection between the second cavity section 132 and the third cavity section 133. Understandably, the cross-sectional area of ​​the third cavity section 133 may be slightly larger than the cross-sectional area of ​​the sampling needle 210 or the cell brush 230. When the piston 220 is in the second position, the piston 220 may abut against the step surface. In the process of the piston 220 moving from the first position to the second position, it not only guides the sampling member 200 through the first opening 110, but also avoids the situation where the sampling member 200 is separated from the cap body 100.

[0078] See also Figure 4 The elastic claw 223 may include at least two springs, and at least two springs may be arranged at intervals along the outer periphery of the first plug body 221. The use of springs can realize elastic support and position limiting of the piston 220, which is easy to manufacture and saves costs. At least two springs may be arranged at intervals along the outer periphery of the first plug body 221, ensuring the consistency of the distance between the piston 220 and the inner wall of the receiving cavity 130, which not only improves the stability of the connection between the elastic claw 223 and the positioning step 134, but also reduces the shaking of the piston 220 in the receiving cavity 130.

[0079] Combined with reference Figure 1 and Figure 2 , the receiving cavity 130 may have a length L1, and the sampling piece 200 may have a length L2, L1 ≥ L2. It is ensured that the sampling piece 200 can be completely received inside the cap body 100, and when the biopsy assembly 10 is sent to the patient's body to reach the sampling area, scratches on other parts of the patient's body can be avoided. Of course, it is not ruled out that a small part of the sampling piece 200 is exposed outside the receiving cavity 130, and it is ensured that the exposed length will not cause harm to the patient.

[0080] Combined with reference Figure 1 and Figure 3, the pressure regulating cavity 140 may have a diameter D, the diameter D≤0.5mm, for example, the diameter D may be 0.5mm, 0.4mm, 0.3mm, etc. The volume of the biopsy assembly 10 is reduced. In this way, the diameter of the external pipeline connected to the pressure regulating cavity 140 may also be less than 0.5mm. The diameter of the external pipeline may be smaller than the diameter of a conventional sampling structure such as a puncture needle or a cell brush. After the external pipeline, the biopsy assembly 10 are matched with the intracavitary detection device (for example, the biopsy assembly 10 is matched with an ultrasonic microprobe), the cross-sectional area of ​​the whole in the radial direction does not exceed the cross-sectional area of ​​the whole in the radial direction after the conventional sampling structure and the intracavitary detection device are arranged side by side, ensuring that the external pipeline, the biopsy assembly 10 can enter the cavity or the instrument channel at the same time after matching with the intracavitary detection device.

[0081] Again, refer to Figures 1 to 3 The cap body 100 may have a large end 150 and a small end 160, and the cap body 100 may gradually decrease from the large end 150 to the small end 160. Specifically, the cap body 100 may be a cone. This shape provides better guiding characteristics during the process of the biopsy assembly 10 being delivered into the patient's body and reaching the position of the sampling area. Of course, the cap body 100 may also be any other suitable shape, such as a sphere, an ellipsoid, etc.

[0082] See again Figure 2 and Figure 3 The sampling member 200 and the first opening 110 can both be arranged on the central axis of the cap body 100, and the first opening 110 can be located on the small end 160. When the sampling member 200 moves from the first position to the second position, it is convenient for the sampling member 200 to pass through the first opening 110, which is easy to operate.

[0083] Exemplarily, there may be a first angle between the sampling member 200 and the central axis of the cap body 100, and the first angle range may be 0° to 180°, for example, 0°, 30°, 90°, 180°, etc. Understandably, the sampling member 200 and the first opening 110 may both be disposed on the central axis of the cap body 100, and the first opening 110 may be located on the small end 160. At this time, the angle between the central axis of the sampling member 200 and the cap body 100 may be 0°. Since the receiving cavity 130 is used to receive the sampling member 200, the central axis of the sampling member 200 may be parallel to or coaxial with the central axis of the receiving cavity 130. According to the relationship between the central axis of the sampling member 200 and the central axis of the cap body 100, the central axis of the receiving cavity 130 and the central axis of the cap body 100 may have the same relationship. Specifically, when the sampling piece 200 is tilted relative to the central axis of the cap body 100, the first opening 110 can be located on the central axis of the cap body 100, and the receiving cavity 130 can be tilted relative to the central axis of the cap body 100; the first opening 110 may also not be located on the central axis of the cap body 100 (that is, located at other positions of the cap body 100), and the receiving cavity 130 can be tilted relative to the central axis of the cap body 100. In this way, for different parts to be tested in the patient's body, in order to facilitate sampling, a corresponding appropriate biopsy component 10 can be selected so that the biopsy component 10 can be applicable to a variety of scenarios. The sampling piece 200 is at a certain angle to the central axis of the cap body 100, so that the sampling piece 200 can be located in the detection area of ​​the intracavitary detection device, and then the position of the sampling piece 200 is determined based on the detected information to achieve accurate sampling.

[0084] Exemplarily, there may be a second angle between the central axis of the storage cavity 130 and the central axis of the cap body 100, and the second angle may be 0° to 60°, for example, 0°, 30°, 45°, 60°, etc. Since the storage cavity 130 is used to store the sampling member 200, the central axis of the storage cavity 130 may be parallel or coaxial with the central axis of the sampling member 200. According to the relationship between the central axis of the storage cavity 130 and the central axis of the cap body 100, the central axis of the sampling member 200 may have the same relationship with the central axis of the cap body 100. This arrangement of the storage cavity 130 can make it occupy as little of the entire central axis area of ​​the cap body 100 as possible, so as to form as large a avoidance space as possible for other devices.

[0085] For example, the cross section of the receiving cavity 130 may be circular, which is not only convenient for the sampling member 200 to move in the receiving cavity 130, but also convenient for processing and manufacturing. The cross section of the receiving cavity 130 may also be any other suitable shape, such as square, oval, etc.

[0086] Exemplarily, the above-mentioned biopsy component 10 can be arranged on an interventional device, which can enter the human body cavity along the natural opening, surgical opening or the forceps channel of other medical devices. Further, the interventional device is also provided with intracavity detection devices such as an ultrasonic transducer 40 and an optical camera. The biopsy component 10 can be used synchronously with the intracavity detection device in one inspection. The interventional instrument carrying both the biopsy component 10 and the intracavity detection device can also be called an intracavity detection biopsy device. Further, if the intracavity detection device is an ultrasonic transducer 40, the intracavity detection biopsy device can be called an ultrasonic microprobe. If the intracavity detection device is an optical camera, the intracavity detection biopsy device can be called an endoscope body. Furthermore, the ultrasonic transducer 40 and the optical camera can be oriented in front, to the side or to the front side of the interventional device, so as to detect the cavity state of the interventional device during its entry into the human body cavity.

[0087] According to another aspect of the present invention, an ultrasonic microprobe is provided. Figure 8 and Fig. 9 , the ultrasonic microprobe may include a probe body 30, an ultrasonic transducer 40 and the above-mentioned biopsy assembly 10. The biopsy assembly 10 may be arranged at the distal end of the probe body 30. In this way, the cross-sectional area of ​​the biopsy assembly 10 in the radial direction after being combined with the probe body 30 does not exceed the maximum cross-sectional area of ​​the original probe body 30, ensuring that the ultrasonic microprobe formed by the combination of the biopsy assembly 10 and the probe body 30 can enter the cavity or instrument channel. Of course, it is not excluded that the biopsy assembly 10 is arranged at any other suitable position. The ultrasonic transducer 40 may be arranged in the probe body 30. The probe body 30 may be sealed to prevent the ultrasonic transducer 40 from being contaminated. Among them, the ultrasonic transducer 40 may have an emitting surface 401. The emitting surface 401 may emit ultrasonic waves to its scanning field of view to form an ultrasonic imaging area. The biopsy assembly 10 may be located in the ultrasonic imaging area. In this way, the ultrasonic microprobe integrates the functions of ultrasonic imaging and biopsy sampling. The operator can observe the position of the biopsy component 10 in real time under the guidance of the ultrasonic image, thereby avoiding the sampling from deviating from the actual position and improving the accuracy of the sampling. Furthermore, the storage cavity 130 and the pressure regulating cavity 140 of the biopsy component 10 will not occupy the entire axial center area of ​​the ultrasonic microprobe, but can form an escape space for the ultrasonic transducer 40 through a staggered setting. The ultrasonic transducer 40 and the biopsy component 10 can be respectively set at different positions in the axial direction, that is, there is no need to set the biopsy component channel and the ultrasonic transducer channel in the axial direction respectively, so that the biopsy component 10 and the ultrasonic transducer 40 can be arranged as compactly as possible, thereby reducing the radial size of the ultrasonic microprobe, so that the ultrasonic microprobe can be smoothly inserted into the cavity or instrument channel.

[0088] The probe body 30 can be divided into a proximal section and a distal section. The distal section can be closer to the distal end than the proximal section. The ultrasonic transducer 40 can be arranged in the distal section. The proximal section can be 1500mm to 2500mm in length, for example, the length can be 1500mm, 2100mm, 2500mm, etc. The distal section can be 20mm to 100mm in length, for example, the length can be 20mm, 50mm, 100mm, etc. Ensure that the ultrasonic microprobe has sufficient length to examine the patient. The diameter of the probe body 30 can be 0.2mm to 1.7mm, for example, the diameter can be 0.2mm, 1.4mm, 1.7mm. Ensure that the probe body 30 can accommodate the ultrasonic transducer 40. The probe body 30 can also use a tough material, and a material with good toughness can better adapt to the operation requirements such as bending and twisting, while reducing the damage caused by environmental changes in the patient's body. The probe body 30 is bendable at the distal end, which can drive the biopsy component 10 to bend in the scanning direction of the ultrasonic transducer 40, so that the biopsy component 10 falls into the ultrasonic imaging area. In some embodiments, the ultrasonic transducer 40 and the biopsy component 10 can be radially staggered. For example, the biopsy component 10 is located on or above the central axis, and the lower edge of the ultrasonic transducer 40 is located below the central axis, so that the sampling piece 200 is located in the ultrasonic imaging area of ​​the ultrasonic transducer 40. The material of the biopsy component 10 can be the same as that of the probe body 30, which not only improves the integrity of the biopsy component 10 and the probe body 30, but also facilitates manufacturing. Of course, the biopsy component 10 can also be made of any suitable material as long as it meets the requirements of biocompatibility. The distal end can be made of a material with good sound transmission effect to ensure smooth propagation of ultrasonic energy.

[0089] Again, refer to Figure 8 and Fig. 9 For example, the biopsy assembly 10 is detachably connected to the probe body 30. The biopsy assembly 10 can be a disposable product, that is, it can be discarded after use. The safety of the biopsy operation is enhanced and the risk of cross infection is reduced.

[0090] Combined with reference Figure 2 , Figure 3 , Figure 6 , Figure 7 , Figure 8 and Fig. 9, a fixing portion 170 may be provided at one end of the cap body 100 away from the first opening 110, and a fixing matching portion 301 may be provided at the distal end of the probe body 30, and the fixing portion 170 may be connected to the fixing matching portion 301. The material of the fixing portion 170 and the material of the fixing matching portion 301 may be the same as the material of the probe body 30 to improve durability. The material of the fixing portion 170 and the material of the fixing matching portion 301 may also be a metal material (such as stainless steel, etc.), polyvinyl chloride (Polyvinyl Chloride), silicone, etc. that meet biocompatibility and have an acoustic impedance close to that of human soft tissue. The ultrasonic images of these materials are relatively blurred or not developed to prevent affecting the development of the biopsy component 10. Specifically, the fixing portion 170 may be a groove. The fixing matching portion 301 may be a convex column. The fixing matching portion 301 and the probe body 30 may be connected by bonding, or by other methods such as a keyway connection. Of course, the fixing portion 170 may be a convex column, and the fixing matching portion 301 may be a groove. The fixing portion 170 and the cap body 100 may be connected by adhesive bonding, or by keyway connection, etc. In this way, the probe body 30 can drive the biopsy assembly 10 to rotate or move synchronously for sampling, thus ensuring the consistency and convenience of the operation.

[0091] For example, the fixing portion 170 can be threadedly connected to the fixing matching portion 301. This not only ensures the stability of the connection between the biopsy assembly 10 and the probe body 30, but also facilitates installation or disassembly and is easy to manufacture. Of course, the fixing portion 170 and the fixing matching portion 301 can be connected by any suitable connection method, such as a keyway connection, a snap connection, etc.

[0092] In some embodiments, the biopsy component 10 and the probe body 30 may also be an integrated structure, and the biopsy component 10 can be reused after being cleaned and disinfected, thereby saving costs.

[0093] See also Fig. 9 , the emitting surface 401 and the central axis of the probe body 30 may have an angle α, and the angle α may be 0° to 90°, for example, the angle α may be 0°, 30°, 60°, 90°, etc. Of course, the biopsy component 10 may also be located within the ultrasound imaging area by changing the position or angle of the biopsy component 10. By ensuring that the biopsy component 10 is located within the ultrasound imaging area, accurate biopsy is achieved, thereby improving the safety of the biopsy.

[0094] See again Fig. 9, the ultrasonic transducer 40 can rotate around the central axis of the probe body 30 or can be withdrawn along the central axis of the probe body 30 to achieve multi-directional detection, so that the ultrasonic image is more comprehensive and coherent, thereby more accurately reflecting the patient's internal information. A drive shaft 50 can be provided in the probe body 30, and the drive shaft 50 can be arranged concentrically with the probe body 30. The ultrasonic transducer 40 can be arranged on one side of the drive shaft 50, and the ultrasonic transducer 40 can be rotated 360 degrees around the central axis through the drive shaft 50, or can be withdrawn relative to the distal end of the probe body 30. Of course, the ultrasonic transducer 40 can also be withdrawn relative to the distal end of the probe body 30 while rotating through the drive shaft 50. The ultrasonic transducer 40 can be connected to the seat assembly through the cable inside the drive shaft 50. The seat assembly can be located at the joint of the ultrasonic microprobe. A transmission mechanism can be provided at the joint of the ultrasonic microprobe, and the transmission mechanism can be engaged with the controller rotation mechanism to achieve mechanical connection. When in use, the ultrasonic transducer 40 can rotate with the driving shaft 50 under the drive of the controller, and a 360-degree circular scan or spiral scan can be performed on the cavity, pipeline, etc. in the patient's body. The space between the driving shaft 50 and the probe body 30 can be filled with coupling fluid to ensure that the sound waves can be transmitted smoothly.

[0095] According to another aspect of the present invention, an ultrasonic endoscope is provided. The ultrasonic endoscope may include a host, an endoscope body and the above-mentioned ultrasonic microprobe. The endoscope body may have an image acquisition unit and a clamp channel. At least a portion of the ultrasonic microprobe may pass through the clamp channel to enter the cavity to be inspected. The image acquisition unit and the ultrasonic microprobe may be electrically connected to the host, respectively. In this way, the ultrasonic microprobe with a biopsy component 10 may pass through the clamp channel of the ultrasonic endoscope, thereby avoiding sampling deviation from the actual position and improving the accuracy of sampling. Among them, the image acquisition unit may be an optical camera for acquiring optical images (also called endoscopic images). The optical image acquired by the optical camera and / or the ultrasonic image acquired by the ultrasonic transducer 40 on the ultrasonic microprobe may be combined to evaluate the state of the cavity to be inspected and determine the position of the sampling component to control the sampling of the sampling component.

[0096] The ultrasonic endoscope may also include a display. The display may be electrically connected to the host. The display may be used to display optical images and / or ultrasonic images. Under the guidance of the host's image post-processing recognition algorithm, the operator may observe the display to perform precise biopsy, thereby avoiding sampling deviation from the actual position and improving the accuracy of sampling.

[0097] According to another aspect of the present invention, a biopsy sampling system is provided, comprising a host and an ultrasonic microprobe as described above for sampling, wherein the host is electrically connected to the ultrasonic microprobe and implements the following steps: acquiring an image to be inspected through an ultrasonic transducer 40, and determining a target sampling area according to the image to be inspected; determining the initial position of the sampling member 200 in the image to be inspected; predicting the moving path of the sampling member 200 from the initial position to the target sampling area, and controlling the sampling member 200 to move from the initial position to the target sampling area according to the moving path; after the sampling member 200 moves to the target sampling area, the sampling member 200 is used to perform biopsy sampling on the target sampling area. It should be noted that the initial position may be the first position or the second position of the sampling member 200. The moving path may be a path from the first position to the sampling position of the sampling member 200 in the target sampling area or a path from the second position to the sampling position of the sampling member 200 in the target sampling area.

[0098] When the biopsy component 10 is detachable relative to the probe body 30 and an ultrasonic imaging device is used to detect the patient's respiratory tract, the ultrasonic endoscope can be a bronchoscope. The bronchoscope can collect images of the area above the fourth-order bronchus. Take the biopsy component 10 out of the separate sealed packaging bag, and connect the fixing part 170 with the fixing matching part 301 so that the biopsy component 10 is installed on the probe body 30 to form an ultrasonic microprobe. The ultrasonic microprobe is sent from the clamp channel of the bronchoscope into the area below the fourth-order bronchus, and the ultrasonic imaging can be turned on after the distal end is extended from the clamp channel of the bronchoscope. Under the real-time guidance of the bronchoscope and the ultrasonic image, the ultrasonic microprobe is sent to a certain depth by controlling the posture of the bronchoscope to reach the position of the sampling area. The ultrasonic transducer 40 emits ultrasonic waves and receives echoes according to a predetermined time sequence. Driven by the drive shaft 50, the probe body 30 rotates around the central axis to obtain a single frame of bronchial cross-sectional image data. After confirming from the ultrasonic image that the biopsy component 10 has reached the position of the sampling area, the sampling member 200 is moved to the outside of the storage cavity 130 by injecting gas or liquid into the pressure regulating cavity 140 to provide positive pressure. When performing a puncture biopsy, the gas or liquid injected into the pressure regulating cavity 140 is extracted before puncture. During puncture, the ultrasonic microprobe can be manually twisted for puncture. The pressure regulating cavity 140 is aspirated to provide negative pressure to absorb the object to be inspected. When performing a brush inspection, the probe body 30 can be manually twisted to drive the cell brush 230 to take the object to be inspected. After the collection is completed, the ultrasonic microprobe is removed from the forceps channel of the bronchoscope to complete the biopsy process.

[0099] Specifically, since the biopsy component 10 can be accommodated in the ultrasound imaging area (i.e., the field of view of ultrasound imaging), the host can calculate the area where the image of the biopsy component 10 is distributed in the ultrasound image. Accordingly, the display will display the mark of the biopsy component 10 area in the image display area of ​​the user interface. After the biopsy component 10 is identified by the post-processing algorithm built into the host (a composite algorithm based on AI, feature recognition, etc. (it can be an existing well-known algorithm or a future algorithm, which is not limited here), the brightness of the biopsy component 10 in the ultrasound image displayed by the display is enhanced by a specific algorithm, assisting the operator to observe the contact between the biopsy component 10 and the sampling area in the ultrasound image. The features of each anatomical structure in the ultrasound image are quite different and easy to distinguish, so these anatomical structures can be identified from the ultrasound image by the post-processing algorithm built into the host. And they are marked separately in the ultrasound image displayed on the display, so as to help the operator establish a safe and effective biopsy path. In this way, the sampling is prevented from deviating from the actual position and the accuracy of the sampling is improved.

[0100] In the description of the present invention, it should be understood that the orientation or positional relationship indicated by directional words such as "front", "back", "up", "down", "left", "right", "lateral", "vertical", "vertical", "horizontal", "top", "bottom", etc. is usually based on the orientation or positional relationship shown in the drawings, and is only for the convenience of describing the present invention and simplifying the description. Unless otherwise specified, these directional words do not indicate or imply that the device or element referred to must have a specific orientation or be constructed and operated in a specific orientation, and therefore cannot be understood as limiting the scope of protection of the present invention; the directional words "inside" and "outside" refer to the inside and outside relative to the contour of each component itself.

[0101] For ease of description, regional relative terms such as "above", "above", "on the upper surface of", "above", etc. may be used here to describe the regional positional relationship between one or more components or features shown in the figure and other components or features. It should be understood that regional relative terms include not only the orientation of the components as described in the figure, but also different orientations in use or operation. For example, if the components in the accompanying drawings are inverted as a whole, the components "above other components or features" or "above other components or features" will include the situation where the components are "below other components or structures" or "below other components or structures". Therefore, the exemplary term "above" may include both "above" and "below". In addition, these components or features may also be positioned at other different angles (e.g., rotated 90 degrees or other angles), and this article is intended to include all of these situations.

[0102] It should be noted that the terms used herein are only for describing specific embodiments and are not intended to limit the exemplary embodiments according to the present application. As used herein, unless the context clearly indicates otherwise, the singular form is also intended to include the plural form. In addition, it should be understood that when the terms "comprise" and / or "include" are used in this specification, it indicates the presence of features, steps, operations, parts, components and / or combinations thereof.

[0103] It should be noted that the terms "first", "second", etc. in the specification and claims of the present application and the above-mentioned drawings are used to distinguish similar objects, and are not necessarily used to describe a specific order or sequence. It should be understood that the numbers used in this way can be interchanged where appropriate, so that the embodiments of the present application described herein can be implemented in an order other than those illustrated or described herein.

[0104] The present invention has been described by the above embodiments, but it should be understood that the above embodiments are only for the purpose of example and description, and are not intended to limit the present invention to the scope of the described embodiments. In addition, it can be understood by those skilled in the art that the present invention is not limited to the above embodiments, and more variations and modifications can be made according to the teachings of the present invention, and these variations and modifications all fall within the scope of the protection claimed by the present invention. The protection scope of the present invention is defined by the attached claims and their equivalents.

Claims

1. A biopsy assembly, characterized in that: include: a cap body, the cap body being provided with a first opening and a second opening, the first opening and the second opening being arranged in a staggered manner, the cap body being provided with a receiving cavity and a pressure regulating cavity, the receiving cavity being communicated with the first opening, the pressure regulating cavity being communicated with the second opening and the receiving cavity, so as to provide positive pressure or negative pressure in the receiving cavity; and a sampling member, the sampling member being at least partially arranged in the receiving cavity and being movable between a first position and a second position relative to the first opening; Wherein, when the positive pressure in the receiving cavity exceeds a first threshold value, the sampling member moves from the first position toward the second position relative to the first opening to at least partially pass through the first opening and extend out of the cap body.

2. The biopsy assembly according to claim 1, characterized in that: The sampling member comprises a sampling needle and a piston. The piston is slidably disposed in the receiving cavity. The sampling needle is disposed on the piston. When the piston is located at the second position, the needle tip of the sampling needle extends out of the cap body.

3. The biopsy assembly according to claim 2, characterized in that: When the negative pressure in the receiving cavity exceeds a second threshold, the sampling needle absorbs the object to be tested.

4. The biopsy assembly according to claim 2, characterized in that: The piston includes a first plug body and a second plug body, the first plug body has an inner cavity, the first plug body has a first port and a second port formed at two ends of the inner cavity, the first port is opposite to the first opening, and the needle tail of the sampling needle is arranged at the first port; a part of the second plug body is located in the inner cavity, and is movable between a third position and a fourth position relative to the first plug body; when the second plug body is in the third position, the second port is opened, and the inner cavity is connected to the pressure regulating cavity; when the second plug body is in the fourth position, the second port is closed.

5. The biopsy assembly according to claim 4, characterized in that: The inner cavity has a first cavity and a second cavity, the first cavity is farther away from the first port than the second cavity, the cross-sectional area of ​​the first cavity is smaller than the cross-sectional area of ​​the second cavity, and a portion of the second plug body passes through the first cavity and extends into the second cavity.

6. The biopsy assembly according to claim 5, characterized in that: The second plug body includes a plate-shaped body, the area of ​​the plate-shaped body is larger than the area of ​​the second port, and when the second plug body is in the fourth position, the plate-shaped body abuts against the end surface of the first plug body away from the first opening to close the second port.

7. The biopsy assembly according to claim 6, characterized in that: The second plug body includes a plurality of penetrating bodies, each of which has a leg and a foot. The first end of the leg is connected to the plate-like body, and the second end of the leg is connected to the foot. The foot passes through the first cavity and extends into the second cavity. There is a gap between the leg and the cavity wall of the first cavity.

8. The biopsy assembly according to claim 1, characterized in that: The sampling member comprises a cell brush and a piston. The piston is slidably disposed in the receiving cavity. The cell brush is disposed on the piston. When the piston is located at the second position, the brush head of the cell brush at least partially extends out of the cap body.

9. The biopsy assembly according to claim 8, characterized in that: The piston includes a first plug body and a second plug body, the first plug body has an inner cavity, the first plug body has a first opening and a second opening respectively formed at both ends of the inner cavity, the first opening is opposite to the first opening, and the tail of the cell brush is arranged at the first opening; a part of the second plug body is located in the inner cavity and closes the second opening.

10. The biopsy assembly according to any one of claims 4 or 9, characterized in that: The first plug body is provided with an elastic claw, and the elastic claw is configured to be in a closed state when the sampling member is located at the first position, and to be in an open state when the sampling member is located at the second position.

11. The biopsy assembly according to claim 10, characterized in that: The receiving cavity has a first cavity section and a second cavity section, the first cavity section is farther away from the first opening than the second cavity section, and the cross-sectional area of ​​at least part of the second cavity section is larger than the cross-sectional area of ​​the first cavity section. When the sampling piece is located at the first position, the elastic claw is located in the first cavity section, and when the sampling piece is located at the second position, the elastic claw is located in the second cavity section.

12. The biopsy assembly according to claim 11, characterized in that: A positioning step is formed at the connection between the first cavity section and the second cavity section, and the elastic claw in the opened state abuts against the positioning step.

13. The biopsy assembly according to claim 10, characterized in that: The elastic claw includes at least two spring leaves, and the at least two spring leaves are arranged at intervals along the outer circumference of the first plug body.

14. The biopsy assembly according to claim 1, characterized in that: The receiving cavity has a length L1, and the sampling piece has a length L2, where L1≥L2.

15. The biopsy assembly according to claim 1, characterized in that: The pressure regulating cavity has a diameter D, and the diameter D is ≤ 0.5 mm.

16. The biopsy assembly according to claim 1, characterized in that: The cap body has a large end and a small end, and the cap body is gradually reduced from the large end to the small end.

17. The biopsy assembly according to claim 16, characterized in that: The sampling piece and the first opening are both arranged on the central axis of the cap body, and the first opening is located on the small end.

18. The biopsy assembly according to any one of claims 1 to 17, characterized in that There is a first angle between the sampling member and the central axis of the cap body, and the first angle is 0° to 180°.

19. The biopsy assembly according to any one of claims 1 to 17, characterized in that: There is a second angle between the central axis of the receiving cavity and the central axis of the cap body, and the second angle is 0° to 60°.

20. The biopsy assembly according to any one of claims 1 to 17, characterized in that The cross section of the receiving cavity is circular.

21. An ultrasonic microprobe, characterized in that: It includes a probe body, an ultrasonic transducer and a biopsy component as described in any one of claims 1 to 20, wherein the biopsy component is arranged on the distal end of the probe body, and the ultrasonic transducer is arranged in the probe body, wherein the ultrasonic transducer has an emitting surface, the emitting surface emits ultrasonic waves to form an ultrasonic imaging area, and the biopsy component is located in the ultrasonic imaging area.

22. The ultrasonic microprobe according to claim 21, characterized in that: The biopsy component is detachably connected to the probe body.

23. The ultrasonic microprobe according to claim 22, characterized in that: A fixing portion is arranged at one end of the cap body away from the first opening, and a fixing matching portion is arranged at the distal end of the probe body, and the fixing portion is connected to the fixing matching portion.

24. The ultrasonic microprobe according to claim 23, characterized in that: The fixing portion is threadedly connected to the fixing matching portion.

25. The ultrasonic microprobe according to claim 21, characterized in that: The emitting surface and the central axis of the probe body have an included angle α, and the included angle α is 0° to 90°.

26. The ultrasonic microprobe according to claim 21, characterized in that: The ultrasonic transducer is rotatable around the central axis of the probe body or retractable along the central axis of the probe body.

27. An ultrasonic endoscope, characterized in that: It comprises a host, an endoscope body and an ultrasonic microprobe as described in any one of claims 21-26, wherein the endoscope body has a clamp channel, the ultrasonic microprobe at least partially passes through the clamp channel to enter the cavity to be inspected, and the ultrasonic microprobe is electrically connected to the host.

28. A biopsy sampling system, characterized in that: The device comprises a host and an ultrasonic microprobe as claimed in any one of claims 21 to 26, wherein the host is electrically connected to the ultrasonic microprobe and implements the following steps: Acquire an image to be inspected by an ultrasonic transducer, and determine a target sampling area according to the image to be inspected; Determining an initial position of the sampled part in the image to be inspected; Predicting a moving path of the sampling member from the initial position to the target sampling area, and controlling the sampling member to move from the initial position to the target sampling area according to the moving path; When the sampling member moves to the target sampling area, the sampling member is used to perform biopsy sampling on the target sampling area.

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