Biopsy assembly, ultrasonic micro probe and ultrasonic endoscope
By designing the storage cavity and pressure regulation cavity of the biopsy component, flexible movement of the sampling component was achieved, solving the problem that it is difficult to insert the intracavitary detection device and the sampling instrument at the same time, thus improving the accuracy and safety of sampling.
Patent Information
- Application Number
- CN202520623619.1
- Authority / Receiving Office
- CN · China
- Patent Type
- Utility models(China)
- Current Assignee / Owner
- Filing Date
- 2025-04-03
- Publication Date
- 2026-04-21
- Estimated Expiration
- 2035-04-03
AI Technical Summary
Existing intracavitary detection devices and sampling instruments are difficult to insert simultaneously into the cavity or instrument channel, causing the sampling position to deviate from the actual position and affecting the accuracy of sampling.
A biopsy assembly was designed, including a cap and a sampling device. By utilizing a receiving cavity and a pressure regulating cavity, positive or negative pressure is applied to the receiving cavity to move the sampling device within the cap, thereby enabling the sampling device to extend or retract and ensuring the accuracy of simultaneous insertion and sampling with the intracavitary detection device.
It improves sampling accuracy, avoids sampling deviation from the actual location, enhances safety and operational stability, and is suitable for biopsy operations in different sampling areas.
Smart Images

Figure CN224140848U_ABST
Abstract
Description
Technical Field
[0001] This utility model relates to the field of medical device technology, specifically to a biopsy component, an ultrasonic microprobe, and an ultrasonic endoscope. Background Technology
[0002] Biopsy (examination of living tissue) is an important diagnostic tool in medicine. It involves obtaining a sample of diseased tissue or cells from a patient for pathological examination to determine the nature, type, and stage of the lesion, providing crucial information for clinical diagnosis and treatment. Biopsy sampling methods include excision biopsy, forceps biopsy, puncture biopsy, and brushing. Biopsies require sampling instruments; for example, the primary sampling instrument in puncture biopsy is the puncture needle, and the primary sampling instrument in brushing biopsy is the cell brush. Puncture needles and cell brushes are important sampling instruments in clinical emergency care and interventional respiratory therapy.
[0003] Current sampling devices, such as puncture needles, mostly consist of a sheath, a needle, and a drive shaft. During the insertion of the needle into the patient to the puncture site where a sample of diseased tissue or cells needs to be obtained, the needle is retracted into the sheath. Once the needle reaches the puncture site, the operator pushes the piston at the proximal end, causing the drive shaft to extend the needle from the sheath. After puncturing the site, the operator withdraws the piston at the proximal end again, thus collecting the sample. Cell brushes mostly consist of a brush head and a catheter. The catheter controls the movement of the brush head to the sampling area to obtain a sample of diseased tissue or cells.
[0004] Sampling instruments often need to be used in conjunction with intracavitary detection devices, such as ultrasound microprobes. However, due to the limited space in cavitary or instrument channels, most existing intracavitary detection devices and sampling instruments cannot be inserted into the cavity or instrument channel simultaneously. Instead, the intracavitary detection device is withdrawn after imaging is completed, and then the sampling instrument is inserted for biopsy. However, over time, or due to factors such as coughing or changes in body position, the original intracavitary detection position may shift during sampling, causing the sample to deviate from its actual location. Utility Model Content
[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, the technical solution of which is as follows.
[0006] The biopsy assembly includes a cap and a sampling component. The cap has a first opening and a second opening, which are offset from each other. The cap has a receiving cavity and a pressure regulating cavity. The receiving cavity is connected to the first opening, and the pressure regulating cavity is connected to the second opening and the receiving cavity to provide positive or negative pressure to the receiving cavity. The sampling component is at least partially disposed in the receiving cavity and is movable between a first position and a second position relative to the first opening. When the positive pressure in the receiving cavity exceeds a first threshold, the sampling component moves from the first position to the second position relative to the first opening to at least partially protrude from the cap.
[0007] The biopsy assembly of this invention, during the process of the operator delivering the biopsy assembly into the patient's body and reaching the sampling area, has the sample retracted within a receiving cavity to avoid scratching other parts of the patient's body. After reaching the sampling area, positive pressure can be provided to the receiving cavity by injecting gas (such as air) or liquid (such as saline) into the pressure regulating cavity. When the positive pressure in the receiving cavity exceeds a first threshold, the sample extends out of the receiving cavity, facilitating the biopsy operation. Thus, based on the cap body with an opening, receiving cavity, and pressure regulating cavity, it is beneficial for the biopsy assembly and the intracavitary detection device to be simultaneously inserted into the cavity or instrument channel, thereby avoiding sampling deviation from the actual position and improving sampling accuracy.
[0008] For example, the sampling device includes a sampling needle and a piston, the piston being slidably disposed within a receiving cavity, the sampling needle being disposed on the piston, and the tip of the sampling needle protruding outside the cap body when the piston is in the second position.
[0009] For example, when the negative pressure in the receiving cavity exceeds a second threshold, the sampling needle aspirates the sample to be tested.
[0010] For example, 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 at both ends of the inner cavity. The first opening is opposite to the first opening. The tail of the sampling needle is located at the first opening. A portion of the second plug body is located in the inner cavity and is movable relative to the first plug body between a third position and a fourth position. When the second plug body is in the third position, the second opening 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 opening is closed.
[0011] For example, the inner cavity has a first cavity and a second cavity, the first cavity being further away from the first opening than the second cavity, the cross-sectional area of the first cavity being smaller than the cross-sectional area of the second cavity, and a portion of the second plug extending through the first cavity into the second cavity.
[0012] For example, the second plug includes a plate-like body with an area larger than the area of the second opening. When the second plug is in the fourth position, the plate-like body abuts against the end face of the first plug away from the first opening to close the second opening.
[0013] For example, the second plug includes a plurality of penetrating bodies, each penetrating body having a leg and a foot, a first end of the leg being connected to a plate-like body, a second end of the leg being connected to a foot, the foot extending through the first cavity into the second cavity, and a gap between the leg and the cavity wall of the first cavity.
[0014] For example, the sampling device includes a cell brush and a piston, the piston being slidably disposed within a receiving cavity, the cell brush being disposed on the piston, and the brush head of the cell brush being at least partially extended outside the cap body when the piston is in a second position.
[0015] For example, 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 at both ends of the inner cavity. The first opening is opposite to the first opening. The tail of the cell brush is disposed at the first opening. A portion of the second plug body is located in the inner cavity and closes the second opening.
[0016] For example, the first plug is provided with an elastic claw, which is configured to be in a closed state when the sampler is in a first position and in an open state when the sampler is in a second position.
[0017] For example, the receiving cavity has a first cavity segment and a second cavity segment, the first cavity segment being further away from the first opening than the second cavity segment, and at least a portion of the cross-sectional area of the second cavity segment being larger than the cross-sectional area of the first cavity segment. When the sampler is in the first position, the elastic claw is located in the first cavity segment, and when the sampler is in the second position, the elastic claw is located in the second cavity segment.
[0018] For example, a positioning step is formed at the connection between the first cavity segment and the second cavity segment, and the elastic claw in the open state abuts against the positioning step.
[0019] For example, the resilient claw includes at least two springs, which are spaced apart along the outer periphery of the first plug.
[0020] For example, the receiving cavity has a length L1, and the sampling element has a length L2, where L1 ≥ L2.
[0021] For example, the pressure regulating channel has a diameter D, where D ≤ 0.5 mm.
[0022] For example, the cap body has a large end and a small end, and the cap body gradually decreases in size from the large end to the small end.
[0023] For example, both the sampling element and the first opening are located on the central axis of the cap body, and the first opening is located at the small end.
[0024] For example, the sampling element and the central axis of the cap body have a first angle, which is 0° to 180°.
[0025] For example, there is a second angle between the central axis of the receiving cavity and the central axis of the cap body, the second angle being 0° to 60°.
[0026] For example, 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 aforementioned biopsy component. The biopsy component is disposed at the distal end of the probe body, and the ultrasonic transducer is disposed inside the probe body. The ultrasonic transducer has an emitting surface that emits ultrasonic waves to form an ultrasonic imaging area, and the biopsy component is located within the ultrasonic imaging area.
[0028] For example, the biopsy component is detachably connected to the probe body.
[0029] For example, a fixing part is provided at the end of the cap body away from the first opening, and a fixing mating part is provided at the far end of the probe body, with the fixing part connected to the fixing mating part.
[0030] For example, the fixing part and the fixing mating part are threaded together.
[0031] For example, the emitting surface and the central axis of the probe body have an angle α, which is 0° to 90°.
[0032] For example, the ultrasonic transducer can be rotated about the central axis of the probe body or retracted 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 main unit, an endoscope body and the aforementioned ultrasonic microprobe. The endoscope body has a clamp channel, and the ultrasonic microprobe passes through the clamp channel at least partially to enter the cavity to be examined. The ultrasonic microprobe is electrically connected to the main unit.
[0034] The aforementioned ultrasonic microprobe and ultrasonic endoscope have the same beneficial effects as the aforementioned biopsy components.
[0035] This utility model description introduces a series of simplified concepts, which will be further explained in detail in the detailed description section. This utility model description is not intended to limit the key features and essential technical features of the claimed technical solution, nor is it intended to determine the scope of protection of the claimed technical solution.
[0036] The advantages and features of this utility model will be described in detail below with reference to the accompanying drawings. Attached Figure Description
[0037] The following drawings, which are incorporated herein by reference as part of this invention, are provided for understanding the invention. The drawings illustrate embodiments of the invention and their descriptions, serving to explain the principles of the invention. In the drawings,
[0038] Figure 1 A perspective view of a biopsy assembly as an exemplary embodiment of the present invention;
[0039] Figure 2 for Figure 1 The cross-sectional view of the biopsy assembly shown (sample in the first position);
[0040] Figure 3 for Figure 1 The cross-sectional view of the biopsy assembly shown (sample taken in the second position);
[0041] Figure 4 for Figure 3 Enlarged view of section A in the middle;
[0042] Figure 5 for Figure 2 and Figure 3 A three-dimensional view of the second plug body in the middle;
[0043] Figure 6 A cross-sectional view of a biopsy assembly (sampler in the first position) as another exemplary embodiment of the present invention;
[0044] Figure 7 A cross-sectional view of a biopsy assembly (sampler in the second position) as another exemplary embodiment of the present invention;
[0045] Figure 8 A perspective view of a portion of an ultrasonic microprobe, which is an exemplary embodiment of the present invention;
[0046] Figure 9 for Figure 8 The image shows a cross-sectional view of a portion of an ultrasonic microprobe.
[0047] The above figures include the following reference numerals:
[0048] 10. Biopsy assembly; 100. Cap body; 110. First opening; 120. Second opening; 130. Reception cavity; 131. First cavity segment; 132. Second cavity segment; 1321. First stepped cavity segment; 1322. Second stepped cavity segment; 1323. Stepped surface; 133. Third cavity segment; 134. Positioning step; 140. Pressure regulating cavity; 150. Large end; 160. Small end; 170. Fixing part; 200. Sampling component; 210. Sampling needle; 211. Pressure flow channel; 220. Piston ; 221, First plug; 2211, Inner cavity; 2211a, First cavity; 2211b, Second cavity; 2212, First opening; 2213, Second opening; 222, Second plug; 2221, Plate-like body; 2222, Penetrating body; 2222a, Leg; 2222b, Foot; 223, Elastic claw; 230, Cell brush; 231, Brush bristles; 232, Brush rod; 30, Probe body; 301, Fixing mating part; 40, Ultrasonic transducer; 401, Emitting surface; 50, Drive shaft. Detailed Implementation
[0049] In the following description, numerous details are provided to enable a thorough understanding of the present invention. However, those skilled in the art will appreciate that the following description merely illustrates preferred embodiments of the present invention, which may be practiced without one or more of these details. Furthermore, to avoid confusion with the present invention, some technical features well-known in the art have not been described in detail.
[0050] To fully understand the embodiments of this utility model, a detailed structure will be presented in the following description. Obviously, the implementation of the embodiments of this utility model is not limited to the specific details familiar to those skilled in the art. Preferred embodiments of this utility model are described in detail below; however, in addition to these detailed descriptions, this utility model may have other embodiments.
[0051] This invention provides a biopsy assembly. The biopsy assembly can be installed on an interventional device, and the host computer connected to the interventional device can perform a biopsy sampling method. A detailed description of a biopsy assembly according to an embodiment of this invention will be provided below with reference to the accompanying drawings.
[0052] See also Figures 1 to 3The biopsy assembly 10 may include a cap 100 and a sampling device 200. The cap 100 may have a first opening 110 and a second opening 120. The first opening 110 and the second opening 120 are offset from each other. The cap 100 may contain a receiving cavity 130 and a pressure regulating cavity 140. The receiving cavity 130 may communicate with the first opening 110. The pressure regulating cavity 140 may connect the second opening 120 and the receiving cavity 130 to provide positive or negative pressure to the receiving cavity 130. That is, the first opening 110, the receiving cavity 130, the pressure regulating cavity 140, and the second opening 120 may be sequentially connected. Specifically, an external tubing can be connected to the second opening 120. This external tubing can communicate with the pressure regulating cavity 140. The end of the external tubing away from the second opening 120 can be connected to a connector and located outside the patient's body, facilitating the connection of syringes, pumps, or other instruments to provide positive or negative pressure to the pressure regulating cavity 140. Alternatively, the external tubing can also extend through the second opening 120 into the pressure regulating cavity 140, ensuring the stability of the connection between the external tubing and the cap 100 and enhancing the seal. The external tubing can be made of a material with good toughness, which better adapts to bending and torsion requirements.
[0053] For example, the first opening 110 and the second opening 120 may be offset axially and / or radially, such that the line connecting the first opening 110 and the second opening 120 forms an 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 housing cavity 130 and the pressure regulating cavity 140 to occupy only part of the central area of the axis, leaving space for other components to pass through, thus making the overall structure more compact and smaller in size.
[0054] The sampling element 200 can be at least partially disposed within the receiving cavity 130, and in a first position relative to the first opening 110 (e.g., Figure 2 ) and the second position (e.g. Figure 3 The sampler 200 can move between the first position and the second position relative to the first opening 110 when the positive pressure in the receiving cavity 130 exceeds the first threshold. This allows the sampler 200 to move relative to the first opening 110 from the first position to the second position, so as to extend at least partially through the first opening 110 and out of the cap 100.
[0055] In this invention, the biopsy assembly 10 is designed so that, during the process of the operator delivering the biopsy assembly 10 into the patient's body and reaching the sampling area, the sampling element 200 is housed within the receiving cavity 130 to avoid scratching other parts of the patient's body. After reaching the sampling area, positive pressure can be provided to the receiving cavity 130 by injecting gas (such as air) or liquid (such as saline) into the pressure regulating cavity 140. When the positive pressure in the receiving cavity 130 exceeds a first threshold, the sampling element 200 extends out of the receiving cavity 130 to facilitate the biopsy operation. Thus, based on the cap 100 with an opening, receiving cavity 130, and pressure regulating cavity 140, the biopsy assembly 10 can be simultaneously inserted into the cavity or instrument channel after cooperating with the intracavitary detection device, thereby avoiding sampling deviation from the actual position and improving sampling accuracy.
[0056] For example, the biopsy assembly 10 can be configured in conjunction with an intracavitary probe to obtain an intracavitary probe biopsy device. Further, the first opening 110 and the second opening 120 are staggered, so the receiving cavity 130 and pressure regulating cavity 140 of the biopsy assembly 10 portion do not occupy the entire axial center region of the intracavitary probe biopsy device; instead, this staggered configuration creates clearance space for the intracavitary probe. The intracavitary probe and the biopsy assembly 10 can be respectively positioned at different locations in the axial direction; that is, it is not necessary to separately provide biopsy assembly channels and intracavitary probe channels in the axial direction. This allows the biopsy assembly 10 and the intracavitary probe to be arranged as compactly as possible, thereby reducing the radial dimension of the intracavitary probe biopsy device and enabling it to be smoothly inserted into the cavity or instrument channel.
[0057] See Figure 2 and Figure 3 The sampling component 200 may include a sampling needle 210 and a piston 220. The piston 220 may be slidably disposed within the receiving cavity 130. The sampling needle 210 may be disposed on the piston 220. When the piston 220 is in the second position, the tip of the sampling needle 210 may extend outside the cap 100. By moving the sampling needle 210 through the piston 220, not only is the sampling needle 210 moved by pressure, but the stability of the sampling needle 210 during movement is also improved.
[0058] When the negative pressure within the receiving cavity 130 exceeds a second threshold, the sampling needle 210 can aspirate the analyte. Understandably, the analyte may include diseased tissue or cell samples. Before the actual puncture, after the sampling needle 210 is extended, all gas or liquid used to provide positive pressure is withdrawn. After the sampling needle 210 is aligned with the puncture site, it can aspirate from the pressure regulating cavity 140 to provide negative pressure to the receiving cavity 130. When the negative pressure within the receiving cavity 130 exceeds the second threshold, the sampling needle 210 aspirates the analyte, thus achieving sample collection. Specifically, the sampling needle 210 may have an internal pressure flow channel 211. When the negative pressure within 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 aspirate the analyte, thereby achieving sample collection. The sampling needle 210 can be of the aspiration type. The diameter of the sampling needle 210 can be less than 0.7 mm. Thus, by adjusting the pressure through the pressure regulating channel 140 to complete the sampling operation of the sampling needle 210, the entire biopsy assembly 10 is small in size, allowing the biopsy assembly 10 to be inserted into the cavity or instrument channel simultaneously after being combined with the intracavitary detection device, thereby avoiding sampling deviation from the actual position and improving the accuracy of sampling.
[0059] See also Figures 2 to 4 The piston 220 may include a first plug 221 and a second plug 222. The first plug 221 may have an inner cavity 2211. The first plug 221 may have a first opening 2212 and a second opening 2213 formed at both ends of the inner cavity 2211. The first opening 2212 may be opposite to the first opening 110. The tail of the sampling needle 210 may be located at the first opening 2212, and the pressure flow channel 211 of the sampling needle 210 communicates with the inner cavity 2211. A portion of the second plug 222 may be located within the inner cavity 2211 and is movable relative to the first plug 221 between a third position and a fourth position. When the second plug 222 is in the third position, the second opening 2213 can be opened, and the inner cavity 2211 can communicate with the pressure regulating cavity 140. When the second plug 222 is in the fourth position, the second opening 2213 can be closed (e.g., ...). Figure 3 At this time, the second plug 222 is in the fourth position. The connection between the second plug 222 and the sampling needle 210 can be any suitable method such as adhesive, snap-fit connection or threaded connection, and is not limited here.
[0060] Taking a respiratory tract biopsy as an example, if a large amount of gas or liquid enters the bronchus, it can cause the patient to cough, potentially leading to the sampling needle 210 scratching the patient. The biopsy assembly 10 provided in this invention injects gas or liquid into the pressure regulating channel 140 to provide positive pressure into the receiving channel 130. When the positive pressure in the receiving channel 130 exceeds a first threshold, the second plug 222 is in a fourth position to close the second opening 2213, preventing a large amount of gas or liquid in the receiving channel 130 from flowing into the patient's body and causing irritation, thus improving safety. Before the sampling needle 210 formally enters the puncture site after extending out of the receiving cavity 130, all gas and liquid used to provide positive pressure are extracted. After the sampling needle 210 punctures the puncture site, the pressure regulating cavity 140 can be aspirated 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, smoothly transmitting the negative pressure to the sampling needle 210, allowing the sampling needle 210 to aspirate the sample. In this way, the biopsy assembly 10 can successfully complete the sampling operation and improves safety.
[0061] 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 further away from the first opening 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 222 may extend through the first cavity 2211a into the second cavity 2211b. The first cavity 2211a and the second cavity 2211b, by cooperating with the second plug 222, confine the portion of the second plug 222 extending into the second cavity 2211b within the second cavity 2211b, thereby preventing the second plug 222 from falling off the first plug 221.
[0062] See also Figure 4 and Figure 5 The second plug 222 may include a plate-like body 2221. The area of the plate-like body 2221 may be larger than the area of the second opening 2213. When the second plug 222 is in the fourth position, the plate-like body 2221 may abut against the end face of the first plug 221 away from the first opening 110 to close the second opening 2213. This not only avoids a large amount of gas or liquid in the receiving cavity 130 from entering the patient's airway and causing irritation to the patient, reducing safety risks, but is also easy to implement, has a simple structure, and reduces costs.
[0063] See again Figure 4 and Figure 5The second plug 222 may include multiple penetrating bodies 2222. Each penetrating body 2222 may have legs 2222a and feet 2222b. A first end of the leg 2222a may be connected to a plate-like body 2221. A second end of the leg 2222a may be connected to the foot 2222b. The foot 2222b may extend through the first cavity 2211a 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 222 is in the third position, the foot 2222b may abut against the limiting step, effectively preventing the second plug 222 from falling off the first plug 221. A gap may exist between the leg 2222a and the cavity wall of the first cavity 2211a. When the pressure regulating channel 140 is suctioned to provide negative pressure to the receiving channel 130, the airflow is ensured to be unobstructed by the second plug 222, and the negative pressure can be smoothly transmitted to the sampling needle 210.
[0064] In some embodiments, the plurality of inserts 2222 can be circumferentially spaced on the side of the plate 2221 opposite to the second opening 2213. There can be equidistant gaps between every two inserts 2222. When the pressure regulating channel 140 is aspirated to provide negative pressure to the receiving channel 130, it further ensures that air is not blocked by the second plug 222, allowing the negative pressure to be smoothly transmitted to the sampling needle 210. Preferably, there can be four inserts 2222, effectively preventing the second plug 222 from falling off the first plug 221 and facilitating manufacturing. Of course, it is not excluded that there can be three, five, etc., inserts 2222. The foot 2222b can be further away from the central axis of the second plug 222 than the leg 2222a, which not only reduces the obstruction of air by the foot 2222b but also effectively prevents the second plug 222 from falling off the first plug 221.
[0065] In some embodiments, the second plug 222 may include a through-body 2222. The through-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 2221. Specifically, the leg 2222a may be connected to the middle of the side of the plate 2221 opposite to the second opening 2213 to ensure the stability of the connection between the leg 2222a and the plate 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 222 is in the third position, the foot 2222b blocks a portion of the first cavity 2211a, and the other portion of the first cavity 2211a communicates with the second cavity 2211b. That is, the shape of the second plug 222 may be "I". When there are multiple feet 2222b, the middle of each foot 2222b can be connected to the leg 2222a and rotated around the leg 2222a, with gaps between the feet 2222b. This not only ensures the stability of the connection between the leg 2222a and the feet 2222b, but also ensures that air is not completely blocked by the second plug 222. Of course, the second plug 222 can be any suitable structure other than the above, ensuring that when the second plug 222 is in the third position, it will not detach from the first plug 221, and when the second plug 222 is in the fourth position, the second opening 2213 can be closed.
[0066] See also Figure 6 and Figure 7 The sampling component 200 may include a cell brush 230 and a piston 220. Specifically, the cell brush 230 may include bristles 231 and a brush handle 232. The number of bristles 231 can be multiple. Multiple bristles 231 can extend 360° perpendicular to the axis of the brush handle 232. The connection method between the bristles 231 and the brush handle 232 can be any suitable method such as adhesive or snap-fit, and is not limited here. The bristles 231 can be made of a rigid material to make it easier for the bristles 231 to pick up the sample. The bristles 231 can have a length perpendicular to the axial direction of the brush handle 232, which can be approximately 1 mm. Along the axial direction of the brush handle 232, multiple bristles 231 can occupy approximately 8 mm of the length of the brush handle 232. The piston 220 can be slidably disposed within the receiving cavity 130. The cell brush 230 can be disposed on the piston 220. When the piston 220 is in the second position, the brush head of the cell brush 230 can extend outside the cap 100. By using piston 220 to drive cell brush 230, not only is it possible to drive cell brush 230 by pressure, but the stability of cell brush 230 during movement is also improved.
[0067] For example, the piston 220 may include a first plug 221 and a second plug 222. The first plug 221 may have an inner cavity 2211. The first plug 221 may have a first opening 2212 and a second opening 2213 formed at both ends of the inner cavity 2211. The first opening 2212 may be opposite to the first opening 110. The tail of the cell brush 230 may be located at the first opening 2212, and a part of the second plug 222 may be located within the inner cavity 2211 and may close the second opening 2213. The connection method between the second plug 222 and the cell brush 230 may be any suitable method such as adhesive, snap-fit connection, or threaded connection, and is not limited here. The second plug 222 may have any suitable shape, and the connection method between the second plug 222 and the first plug 221 may be any suitable method such as adhesive, snap-fit connection, or threaded connection, as long as the second plug 222 closes the second opening 2213.
[0068] Taking a respiratory tract biopsy as an example, if a large amount of gas or liquid enters the bronchus, it can cause the patient to cough, leading the cell brush 230 to mistakenly collect samples from other parts of the body, thus affecting the accuracy of the test results. The biopsy assembly 10 provided in this invention injects gas or liquid into the pressure regulating cavity 140 to provide positive pressure into the receiving cavity 130. When the positive pressure in the receiving cavity 130 exceeds a first threshold, the second plug 222 seals the second opening 2213, preventing a large amount of gas or liquid in the receiving cavity 130 from flowing into the patient's body and causing irritation, thereby affecting the accuracy of the test results. After the cell brush 230 extends out of the receiving cavity 130, the sample is collected by rotating the cell brush 230. This ensures that the biopsy assembly 10 can successfully complete the sampling operation and improves the accuracy of the test results.
[0069] In an embodiment not shown in the figure, the sampling component 200 may include a piston 220 and other suitable sampling tools, ensuring that the sampling tools can be moved from the receiving cavity 130 to outside the cap 100 by the piston 220. Thus, a suitable sampling component 200 can be selected according to the sampling requirements of different sampling areas, allowing the biopsy assembly 10 to be applied in different scenarios.
[0070] See also Figure 2 and Figure 4 The first plug 221 may be provided with an elastic claw 223. The elastic claw 223 may be configured such that it is in a closed state when the sampling member 200 is in the first position (e.g., Figure 2 When the sample 200 is in the second position, it is in an open state (e.g., Figure 4The connection between the elastic claw 223 and the first plug 221 can be any suitable method, such as adhesive bonding or snap-fit connection, and is not limited here. Understandably, the closed state can refer to the surface of the elastic claw 223 being in contact with the surface of the first plug 221, or the surface of the elastic claw 223 forming a small, barely observable angle with the surface of the first plug 221. The open state can refer to the surface of the elastic claw 223 forming a certain angle with the surface of the first plug 221. When the elastic claw 223 is in the closed state, it facilitates the piston 220 to move the sampling needle 210 or cell brush 230. When the elastic claw 223 is in the open state, it facilitates the restraint of the sampling needle 210 or cell brush 230, providing sufficient support for the sampling needle 210 or cell brush 230, thereby ensuring that the sampling needle 210 or cell brush 230 can successfully perform sampling.
[0071] See again Figures 2 to 4The receiving cavity 130 may have a first cavity segment 131 and a second cavity segment 132. The first cavity segment 131 may be further away from the first opening 110 than the second cavity segment 132. At least a portion of the cross-sectional area of the second cavity segment 132 may be larger than the cross-sectional area of the first cavity segment 131. In some embodiments, when the second cavity segment 132 is cylindrical, the cross-sectional area of the entire second cavity segment 132 may be larger than the cross-sectional area of the first cavity segment 131. When the second cavity segment 132 is frustum-shaped, the cross-sectional area of the portion of the second cavity segment 132 near the first cavity segment 131 may be larger than the cross-sectional area of the first cavity segment 131, and the cross-sectional area of the portion of the second cavity segment 132 away from the first cavity segment 131 may be equal to or slightly larger than the cross-sectional area of the first cavity segment 131. The cross-sectional area of the first cavity segment 131 may be slightly larger than the cross-sectional area of the piston 220 to facilitate sliding of the piston 220 within the first cavity segment 131. When the sampling element 200 is in the first position, the elastic claw 223 can be located within the first cavity 131. Since the cross-sectional area of the first cavity 131 is only slightly larger than that of the piston 220, the elastic claw 223 is in a closed state under the squeezing action of the inner wall of the first cavity 131. When the sampling element 200 is in the second position, the elastic claw 223 can be located within the second cavity 132. Since the cross-sectional area of the second cavity 132 is larger, the elastic claw 223 is released after entering the second cavity 132, and the elastic claw 223 can be in an open state. On the one hand, the opening and closing of the elastic claw 223 is achieved by setting two cavities with different cross-sectional areas, which not only simplifies the structure but also facilitates switching. On the other hand, when the elastic claw 223 is in the closed state, the first cavity 131 guides the piston 220 to move the sampling needle 210 or cell brush 230. When the elastic claw 223 is in the open state, it confines the piston 220 to the second cavity 132, providing sufficient support for the sampling needle 210 or cell brush 230, thereby ensuring that the sampling needle 210 or cell brush 230 can successfully perform sampling. It should be noted that when using the sampling needle 210 for sampling, the sampling needle 210 can pick up the sample when the negative pressure in the first cavity 131 exceeds the second threshold.
[0072] See again Figures 2 to 4 A positioning step 134 can be formed at the connection between the first cavity 131 and the second cavity 132, and the elastic claw 223 in the open state can abut against the positioning step 134. When gas or liquid used to provide positive pressure is extracted from the receiving cavity 130, or when the pressure regulating cavity 140 is suctioned to provide negative pressure to the receiving cavity 130, the cooperation between the elastic claw 223 in the open state and the positioning step 134 effectively prevents the sampling needle 210 or cell brush 230 from returning from the second position to the first position, thereby ensuring that the sampling operation is not affected.
[0073] Specifically, along the axial direction of the sampling member 200, the length of the second cavity 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 132 when in the second position, and the elastic claw 223 can be in the open state, further effectively preventing the sampling needle 210 or cell brush 230 from returning from the second position to the first position, thereby ensuring that the sampling operation is not affected.
[0074] The second cavity 132 may have a first stepped cavity 1321 and a second stepped cavity 1322. One end of the first stepped cavity 1321 may be connected to the first cavity 131, and the cross-sectional area of the first stepped cavity 1321 may be larger than that of the first cavity 131. The other end of the first stepped cavity 1321 may be connected to the second stepped cavity 1322 via a stepped surface 1323, and the cross-sectional area of the second stepped cavity 1322 may be equal to that of the piston 220. Thus, when the piston 220 is in the second position, within the second cavity 132, it ensures that the elastic claw 223 can be in an open state within the first stepped cavity 1321, thereby preventing the sampling needle 210 or cell brush 230 from returning from the second position to the first position. The piston 220 is radially upper limited by the second stepped cavity 1322, preventing the sampling needle 210 or cell brush 230 from wobbling radially during sampling, ensuring that the sampling operation is not affected.
[0075] For example, the area of the first opening 110 can be smaller than the cross-sectional area of the piston 220. The second cavity 132 can communicate with the first opening 110. When the piston 220 is in the second position, the piston 220 can abut against the inner wall of the second cavity 132 near the first opening 110. Of course, the area of the first opening 110 can also be equal to or greater than the second cavity 132. A plug with a through hole can be connected to the first opening 110. The area of the through hole can be smaller than the cross-sectional area of the piston 220. When the piston 220 is in the second position, the piston 220 can abut against the side of the plug located in the receiving cavity 130. In this way, the piston 220 is prevented from dislodging from the cap 100 when it moves from the first position to the second position.
[0076] In some embodiments, see again Figure 2 and Figure 3The receiving cavity 130 may also have a third cavity 133. The third cavity 133 may communicate with the second cavity 132 and the first opening 110. The cross-sectional area of the third cavity 133 may be smaller than the cross-sectional area of the first cavity 131. The cross-sectional area of the third cavity 133 may be smaller than the cross-sectional area of the piston 220. A stepped surface may be formed at the connection between the second cavity 132 and the third cavity 133. Understandably, the cross-sectional area of the third cavity 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 stepped surface. During the process of the piston 220 moving from the first position to the second position, it not only guides the sampling piece 200 through the first opening 110, but also prevents the sampling piece 200 from detaching from the cap 100.
[0077] See Figure 4 The elastic claw 223 may include at least two springs, which are spaced apart along the outer periphery of the first plug 221. Using springs provides elastic support and limitation for the piston 220, is easy to manufacture, and saves costs. The spaced-apart arrangement of at least two springs along the outer periphery of the first plug 221 ensures consistent spacing between the piston 220 and the inner wall of the receiving cavity 130, improving the stability of the connection between the elastic claw 223 and the positioning step 134, and reducing the likelihood of the piston 220 wobbling within the receiving cavity 130.
[0078] See also Figure 1 and Figure 2 The receiving cavity 130 may have a length L1, and the sampling component 200 may have a length L2, where L1 ≥ L2. This ensures that the sampling component 200 can be completely housed inside the cap 100, preventing injury to other parts of the patient's body during delivery of the biopsy assembly 10 to the sampling area. Of course, it is possible that a small portion of the sampling component 200 may protrude outside the receiving cavity 130; the extent of this protrusion should not cause harm to the patient.
[0079] See also Figure 1 and Figure 3The pressure regulating cavity 140 can have a diameter D, which is ≤0.5mm. For example, the diameter D can be 0.5mm, 0.4mm, 0.3mm, etc. This reduces the volume of the biopsy assembly 10. Thus, the diameter of the external tubing connected to the pressure regulating cavity 140 can also be less than 0.5mm. The diameter of the external tubing can be smaller than the diameter of conventional sampling structures such as puncture needles or cell brushes. The overall radial cross-sectional area of the external tubing, biopsy assembly 10, and intracavitary detection device (e.g., the biopsy assembly 10 and an ultrasound microprobe) does not exceed the radial cross-sectional area of a conventional sampling structure and intracavitary detection device arranged side-by-side, ensuring that the external tubing, biopsy assembly 10, and intracavitary detection device can simultaneously enter the cavity or instrument channel.
[0080] See again Figures 1 to 3 The cap 100 may have a large end 150 and a small end 160, and the cap 100 may gradually decrease in size from the large end 150 to the small end 160. Specifically, the cap 100 may be conical. This shape provides better guiding properties during the delivery of the biopsy assembly 10 into the patient and to the sampling area. Of course, the cap 100 may also be any other suitable shape, such as a sphere, an ellipsoid, etc.
[0081] See again Figure 2 and Figure 3 Both the sampling element 200 and the first opening 110 can be positioned on the central axis of the cap body 100, and the first opening 110 can be located on the small end 160. During the process of the sampling element 200 moving from the first position to the second position, it is convenient for the sampling element 200 to pass through the first opening 110, making it easy to operate.
[0082] For example, the sampling element 200 and the central axis of the cap body 100 can have a first angle, the first angle range being 0° to 180°, for example, 0°, 30°, 90°, 180°, etc. Understandably, both the sampling element 200 and the first opening 110 can be located on the central axis of the cap body 100, and the first opening 110 can be located on the small end 160. In this case, the included angle between the sampling element 200 and the central axis of the cap body 100 can be 0°. Since the receiving cavity 130 is used to receive the sampling element 200, the central axis of the sampling element 200 can be parallel or coaxial with the central axis of the receiving cavity 130. Based on the relationship between the central axis of the sampling element 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 can have the same relationship. Specifically, when the sampling component 200 is tilted relative to the central axis of the cap 100, the first opening 110 can be located on the central axis of the cap 100, and the receiving cavity 130 can be tilted relative to the central axis of the cap 100; alternatively, the first opening 110 may not be located on the central axis of the cap 100 (i.e., located at other positions on the cap 100), and the receiving cavity 130 can still be tilted relative to the central axis of the cap 100. Thus, for different test sites within the patient's body, appropriate biopsy components 10 can be selected for convenient sampling, making the biopsy component 10 applicable to various scenarios. The sampling component 200 is at a certain angle to the central axis of the cap 100, allowing the sampling component 200 to be located within the detection area of the intracavitary detection device, thereby determining the position of the sampling component 200 based on the detected information and achieving precise sampling.
[0083] For example, the central axis of the receiving cavity 130 can have a second angle with the central axis of the cap 100. This second angle can be 0° to 60°, for example, 0°, 30°, 45°, 60°, etc. Since the receiving cavity 130 is used to receive the sampling component 200, the central axis of the receiving cavity 130 can be parallel or coaxial with the central axis of the sampling component 200. Based on the relationship between the central axis of the receiving cavity 130 and the central axis of the cap 100, the central axis of the sampling component 200 can have the same relationship with the central axis of the cap 100. This arrangement of the receiving cavity 130 minimizes its occupation of the entire central area of the cap 100's axis, thus creating the largest possible clearance space for other devices.
[0084] For example, the cross-section of the receiving cavity 130 can be circular. This not only facilitates the movement of the sample 200 within the receiving cavity 130, but also facilitates manufacturing. The cross-section of the receiving cavity 130 can also be any other suitable shape, such as square, elliptical, etc.
[0085] For example, the biopsy component 10 described above can be disposed on an interventional device capable of entering a human cavity along a natural opening, surgical opening, or the forceps channel of another medical device. Further, the interventional device is also provided with intracavitary detection devices such as an ultrasonic transducer 40 and an optical camera. The biopsy component 10 can be used simultaneously with the intracavitary detection device in a single examination. An interventional device simultaneously equipped with both the biopsy component 10 and the intracavitary detection device can also be referred to as an intracavitary detection biopsy device. Further, if the intracavitary detection device is an ultrasonic transducer 40, the intracavitary detection biopsy device can be referred to as an ultrasonic microprobe. If the intracavitary detection device is an optical camera, the intracavitary detection biopsy device can be referred to as an endoscope. Even further, the ultrasonic transducer 40 and the optical camera can both be oriented in front of, to the side of, or to the side-forward of the interventional device to detect the cavity status during the interventional device's entry into the human cavity.
[0086] According to another aspect of this utility model, an ultrasonic microprobe is provided. (See also...) Figure 8 and Figure 9 The ultrasonic microprobe may include a probe body 30, an ultrasonic transducer 40, and the aforementioned biopsy assembly 10. The biopsy assembly 10 may be disposed at the distal end of the probe body 30. This ensures that the overall radial cross-sectional area of the biopsy assembly 10 combined with the probe body 30 does not exceed the maximum cross-sectional area of the original probe body 30, guaranteeing that the ultrasonic microprobe formed by the biopsy assembly 10 and the probe body 30 can enter a cavity or instrument channel. Of course, the biopsy assembly 10 may be disposed in any other suitable location. The ultrasonic transducer 40 may be disposed within the probe body 30. The probe body 30 may be sealed to prevent contamination of the ultrasonic transducer 40. The ultrasonic transducer 40 may have an emitting surface 401. The emitting surface 401 can emit ultrasonic waves within its scanning field of view to form an ultrasonic imaging area. The biopsy assembly 10 may be located within the ultrasonic imaging area. Thus, the ultrasonic microprobe integrates ultrasonic imaging and biopsy sampling functions, allowing the operator to observe the position of the biopsy component 10 in real time under the guidance of ultrasound images, thereby avoiding sampling deviation from the actual position and improving sampling accuracy. Furthermore, the receiving cavity 130 and pressure regulating cavity 140 of the biopsy component 10 do not occupy the entire central area of the ultrasonic microprobe's axis; instead, they can be staggered to create clearance space for the ultrasonic transducer 40. The ultrasonic transducer 40 and the biopsy component 10 can be positioned at different locations along the axial direction, meaning there is no need to separately set biopsy component channels and ultrasonic transducer channels in the axial direction. This allows the biopsy component 10 and ultrasonic transducer 40 to be arranged as compactly as possible, thereby reducing the radial size of the ultrasonic microprobe and enabling it to be smoothly inserted into the cavity or instrument channel.
[0087] The probe body 30 can be divided into a proximal segment and a distal segment. The distal segment can be located further distally than the proximal segment. The ultrasonic transducer 40 can be disposed within the distal segment. The proximal segment can be 1500mm to 2500mm in length, for example, 1500mm, 2100mm, 2500mm, etc. The distal segment can be 20mm to 100mm in length, for example, 20mm, 50mm, 100mm, etc. This ensures 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, 0.2mm, 1.4mm, 1.7mm, etc. This ensures that the probe body 30 can accommodate the ultrasonic transducer 40. The probe body 30 can also be made of a flexible material. A flexible material can better adapt to bending, torsion, and other operational requirements, while reducing damage caused by environmental changes within the patient's body. The probe body 30 is flexible at its distal end, allowing the biopsy assembly 10 to bend in the scanning direction of the ultrasonic transducer 40, thus placing the biopsy assembly 10 within the ultrasonic imaging area. In some embodiments, the ultrasonic transducer 40 and the biopsy assembly 10 can be radially offset; for example, the biopsy assembly 10 may be located on or above the central axis, while the lower edge of the ultrasonic transducer 40 may be below the central axis, placing the sample 200 within the ultrasonic imaging area of the ultrasonic transducer 40. The biopsy assembly 10 can be made of the same material as the probe body 30, improving the overall integrity of the biopsy assembly 10 and the probe body 30 and facilitating manufacturing. Alternatively, the biopsy assembly 10 can be made of any suitable material, as long as it meets biocompatibility requirements. The distal end can be made of a material with good sound transmission to ensure smooth ultrasound propagation.
[0088] See again Figure 8 and Figure 9 For example, the biopsy assembly 10 is detachably connected to the probe body 30. The biopsy assembly 10 can be a single-use product, i.e., it can be discarded after use. This enhances the safety of the biopsy procedure and reduces the risk of cross-infection.
[0089] See also Figure 2 , Figure 3 , Figure 6 , Figure 7 , Figure 8 and Figure 9A fixing part 170 can be provided at the end of the cap 100 away from the first opening 110, and a fixing mating part 301 can be provided at the distal end of the probe body 30. The fixing part 170 can be connected to the fixing mating part 301. The materials of the fixing part 170 and the fixing mating part 301 can be the same as the materials of the probe body 30 to improve durability. The materials of the fixing part 170 and the fixing mating part 301 can also be metal (e.g., stainless steel), polyvinyl chloride, silicone, or other materials that meet biocompatibility requirements and have an acoustic impedance close to that of human soft tissue. These materials produce less visible or no ultrasound images to prevent affecting the imaging of the biopsy component 10. Specifically, the fixing part 170 can be a groove. The fixing mating part 301 can be a protrusion. The fixing mating part 301 and the probe body 30 can be connected by adhesive bonding, keyway connection, or other methods. Of course, the fixing part 170 can be a protrusion, and the fixing mating part 301 can be a groove. The fixing part 170 and the cap body 100 can be connected by adhesive or by other means such as keyway connection. 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 operation.
[0090] For example, the fixing part 170 can be threadedly connected to the fixing mating part 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 part 170 and the fixing mating part 301 can be connected by any suitable connection method, such as keyway connection, snap-fit connection, etc.
[0091] In some embodiments, the biopsy component 10 and the probe body 30 can also be an integral structure, and the biopsy component 10 can be reused after cleaning and disinfection, saving costs.
[0092] See Figure 9 The emitting surface 401 and the central axis of the probe body 30 can have an angle α, which can be 0° to 90°, for example, 0°, 30°, 60°, 90°, etc. Of course, the position or angle of the biopsy component 10 can also be changed to place the biopsy component 10 within the ultrasound imaging area. By ensuring that the biopsy component 10 is within the ultrasound imaging area, precise biopsy is achieved, thereby improving the safety of the biopsy.
[0093] See again Figure 9The ultrasonic transducer 40 is rotatable around the central axis of the probe body 30 or retractable along the central axis of the probe body 30 to achieve multi-directional detection, making the ultrasound images more comprehensive and coherent, and thus more accurately reflecting the patient's internal information. A drive shaft 50 can be installed inside the probe body 30, and the drive shaft 50 can be concentrically positioned with the probe body 30. The ultrasonic transducer 40 can be located on one side of the drive shaft 50, and the ultrasonic transducer 40 can rotate 360 degrees around the central axis via the drive shaft 50, or retract relative to the distal end of the probe body 30. Alternatively, the ultrasonic transducer 40 can also retract relative to the distal end of the probe body 30 while rotating via the drive shaft 50. The ultrasonic transducer 40 can be connected to the base assembly via a cable inside the drive shaft 50. The base assembly can be located at the connector of the ultrasonic microprobe. A transmission mechanism can be installed at the connector of the ultrasonic microprobe, and the transmission mechanism can engage with the controller rotation mechanism to achieve a mechanical connection. In use, the ultrasound transducer 40 rotates with the drive shaft 50 under the control of the controller, allowing for 360-degree circumferential or helical scanning of cavities and tubes within the patient's body. The space between the drive shaft 50 and the probe body 30 can be filled with coupling fluid to ensure smooth propagation of sound waves.
[0094] According to another aspect of the present invention, an ultrasonic endoscope is provided. The ultrasonic endoscope may include a main unit, an endoscope body, and the aforementioned ultrasonic microprobe. The endoscope body may have an image acquisition unit and a clamp channel. The ultrasonic microprobe can at least partially pass through the clamp channel to enter the cavity to be examined. The image acquisition unit and the ultrasonic microprobe can be electrically connected to the main unit, respectively. Thus, the ultrasonic microprobe with the biopsy component 10 can pass through the clamp channel of the ultrasonic endoscope, thereby avoiding sampling deviation from the actual position and improving sampling accuracy. The image acquisition unit can be an optical camera for acquiring optical images (also called endoscopic images). The optical images acquired by the optical camera and / or the ultrasonic images acquired by the ultrasonic transducer 40 on the ultrasonic microprobe can be combined to assess the state of the cavity to be examined and determine the position of the sampling component, thereby controlling the sampling component to take samples.
[0095] Endoscopic ultrasound may also include a display. The display may be electrically connected to the host unit. The display may be used to display optical and / or ultrasound images. Guided by the host unit's image post-processing recognition algorithm, the operator can observe the display for precise biopsies, thereby avoiding sampling deviation from the actual location and improving sampling accuracy.
[0096] According to another aspect of this utility model, a biopsy sampling system is provided, comprising a main unit and an ultrasonic microprobe as described above. The main unit is electrically connected to the ultrasonic microprobe and performs the following steps: acquiring an image to be examined through an ultrasonic transducer 40, and determining a target sampling area based on the image; determining the initial position of the sampling element 200 in the image; predicting the movement path of the sampling element 200 from the initial position to the target sampling area, and controlling the sampling element 200 to move from the initial position to the target sampling area according to the movement path; and performing biopsy sampling on the target sampling area using the sampling element 200 after the sampling element 200 has moved to the target sampling area. It should be noted that the initial position can be either a first position or a second position of the sampling element 200. The movement path can be either the path from the first position to the sampling position of the sampling element 200 in the target sampling area or the path from the second position to the sampling position of the sampling element 200 in the target sampling area.
[0097] When the biopsy assembly 10 is detachable from the probe body 30 and an ultrasound imaging device is used to examine the patient's airway, the ultrasound endoscope can be a bronchoscope. The bronchoscope can acquire images of the area above the fourth-order bronchus. The biopsy assembly 10 is removed from its individual sealed packaging bag, and the fixing part 170 is connected to the fixing mating part 301 to mount the biopsy assembly 10 on the probe body 30, forming an ultrasound microprobe. The ultrasound microprobe is inserted through the bronchoscope's clamping channel into the area below the fourth-order bronchus; once the distal end extends out of the bronchoscope's clamping channel, ultrasound imaging can be initiated. Under real-time guidance from the bronchoscope and the ultrasound image, the ultrasound microprobe is inserted to a certain depth by controlling the bronchoscope's posture to reach the sampling area. The ultrasound transducer 40 emits ultrasound waves according to a predetermined timing sequence and receives the echoes. Driven by the drive shaft 50, it rotates once around the central axis of the probe body 30, acquiring a single frame of bronchial cross-sectional image data. After confirming from the ultrasound image that the biopsy component 10 has reached the sampling area, gas or liquid is injected into the pressure regulating channel 140 to provide positive pressure, causing the sampling component 200 to move outside the receiving channel 130. Before puncture, the gas or liquid injected into the pressure regulating channel 140 is withdrawn. During puncture, the ultrasound microprobe can be manually rotated. The pressure regulating channel 140 is aspirated to provide negative pressure, aspirating the sample. During brushing, the probe body 30 can be manually rotated to move the cell brush 230 to collect the sample. After collection, the ultrasound microprobe is removed from the bronchoscopy forceps, completing the biopsy process.
[0098] Specifically, since the biopsy component 10 can be accommodated within the ultrasound imaging area (i.e., the field of view of ultrasound imaging), the host computer can calculate the distribution area of the biopsy component 10 within the ultrasound image. Based on this, the display shows a marker for the area of the biopsy component 10 in the image display area of the user interface. After identifying the biopsy component 10 using a post-processing algorithm built into the host computer (a composite algorithm based on AI, feature recognition, etc. (which can be a known algorithm or a future algorithm, not limited here)), the brightness of the biopsy component 10 in the ultrasound image displayed on the display is enhanced using a specific algorithm, assisting the operator in observing the contact between the biopsy component 10 and the sampling area in the ultrasound image. Since the characteristics of various anatomical structures in ultrasound images differ significantly and are easily distinguishable, these anatomical structures can be identified from the ultrasound image using the host computer's built-in post-processing algorithm. These structures are then marked on the ultrasound image displayed on the display, thereby helping the operator establish a safe and effective biopsy path. This avoids sampling deviating from the actual location and improves sampling accuracy.
[0099] In the description of this utility model, it should be understood that the directional terms such as "front", "rear", "up", "down", "left", "right", "horizontal", "vertical", "horizontal", "top", and "bottom" indicate the orientation or positional relationship, which are usually based on the orientation or positional relationship shown in the accompanying drawings. They are only for the convenience of describing this utility model and simplifying the description. Unless otherwise stated, these directional terms do not indicate or imply that the device or element referred to must have a specific orientation or be constructed and operated in a specific orientation, and therefore should not be construed as a limitation on the scope of protection of this utility model. The directional terms "inner" and "outer" refer to the inner and outer contours of each component itself.
[0100] For ease of description, relative terms such as "above," "over," "on the upper surface of," and "above" are used here to describe the regional positional relationship of one or more components or features shown in the figures to other components or features. It should be understood that relative terms include not only the orientation of the component as depicted in the figure but also different orientations during use or operation. For example, if the components in the figures are inverted as a whole, "above" or "above other components or features" will include cases where the component is "below" or "under" other components or features. Thus, the exemplary term "above" can include both "above" and "below." Furthermore, these components or features may also be positioned at other different angles (e.g., rotated 90 degrees or other angles), and this document intends to include all such cases.
[0101] It should be noted that the terminology used herein is for the purpose of describing particular embodiments only and is not intended to limit the exemplary embodiments according to this application. As used herein, the singular form is intended to include the plural form as well, unless the context clearly indicates otherwise. Furthermore, it should be understood that when the terms "comprising" and / or "including" are used in this specification, they indicate the presence of features, steps, operations, parts, components, and / or combinations thereof.
[0102] It should be noted that the terms "first," "second," etc., used in the specification, claims, and accompanying drawings of this application are used to distinguish similar objects and are not necessarily used to describe a specific order or sequence. It should be understood that such data can be interchanged where appropriate so that the embodiments of this application described herein can be implemented in sequences other than those illustrated or described herein.
[0103] This utility model has been described through the above embodiments. However, it should be understood that the above embodiments are for illustrative purposes only and are not intended to limit the utility model to the described embodiments. Furthermore, those skilled in the art will understand that this utility model is not limited to the above embodiments, and many more variations and modifications can be made based on the teachings of this utility model, all of which fall within the scope of protection claimed by this utility model. The scope of protection of this utility model is defined by the appended claims and their equivalents.
Claims
1. A biopsy assembly comprising: include: The cap body has a first opening and a second opening, which are offset from each other. The cap body has a storage cavity and a pressure regulating cavity. The storage cavity is connected to the first opening, and the pressure regulating cavity is connected to the second opening and the storage cavity to provide positive or negative pressure to the storage cavity. The cap body also includes a sampling device, which is at least partially disposed in the storage cavity and is movable relative to the first opening between a first position and a second position. When the positive pressure within the receiving cavity exceeds a first threshold, the sampling member moves relative to the first opening from the first position toward the second position to extend at least partially through the first opening out of the cap body.
2. The biopsy assembly of claim 1, wherein, The sampling device includes a sampling needle and a piston. The piston is slidably disposed in the receiving cavity, and the sampling needle is disposed on the piston. When the piston is in the second position, the tip of the sampling needle extends out of the cap body.
3. The biopsy assembly of claim 2, wherein, When the negative pressure in the receiving cavity exceeds the second threshold, the sampling needle draws up the sample to be tested.
4. The biopsy assembly of claim 2, wherein, 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 at both ends of the inner cavity. The first opening is opposite to the first opening. The tail of the sampling needle is located at the first opening. A portion of the second plug body is located in the inner cavity and is movable relative to the first plug body between a third position and a fourth position. When the second plug body is in the third position, the second opening 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 opening is closed.
5. The biopsy assembly of claim 4, wherein, The inner cavity has a first cavity and a second cavity, the first cavity being further away from the first opening than the second cavity, the cross-sectional area of the first cavity being smaller than the cross-sectional area of the second cavity, and a portion of the second plug extending through the first cavity into the second cavity.
6. The biopsy assembly of claim 5, wherein, The second plug includes a plate-shaped body with an area larger than the area of the second opening. When the second plug is in the fourth position, the plate-shaped body abuts against the end face of the first plug away from the first opening to close the second opening.
7. The biopsy assembly of claim 6, wherein, The second plug includes a plurality of penetrating bodies, each penetrating body having a leg and a foot. A first end of the leg is connected to the plate-like body, and a second end of the leg is connected to the foot. The foot extends through the first cavity into the second cavity, and there is a gap between the leg and the cavity wall of the first cavity.
8. The biopsy assembly of claim 1, wherein, The sampling device includes a cell brush and a piston. The piston is slidably disposed within the receiving cavity, and the cell brush is disposed on the piston. When the piston is in the second position, the brush head of the cell brush extends at least partially out of the cap body.
9. The biopsy assembly of claim 8, wherein, 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 at both ends of the inner cavity. The first opening is opposite to the first opening. The tail of the cell brush is located at the first opening. A portion of the second plug body is located in the inner cavity and closes the second opening.
10. The biopsy assembly of any one of claims 4 or 9, wherein, The first plug is provided with an elastic claw, which is configured to be in a closed state when the sampling element is in the first position and in an open state when the sampling element is in the second position.
11. The biopsy assembly of claim 10, wherein, The receiving cavity has a first cavity segment and a second cavity segment. The first cavity segment is farther away from the first opening than the second cavity segment. At least part of the cross-sectional area of the second cavity segment is larger than the cross-sectional area of the first cavity segment. When the sampling member is located in the first position, the elastic claw is located in the first cavity segment. When the sampling member is located in the second position, the elastic claw is located in the second cavity segment.
12. The biopsy assembly of claim 11, wherein, A positioning step is formed at the connection between the first cavity segment and the second cavity segment, and the elastic claw in the open state abuts against the positioning step.
13. The biopsy assembly of claim 10, wherein, The elastic claw includes at least two springs, which are spaced apart along the outer periphery of the first plug.
14. The biopsy assembly of claim 1, wherein, The receiving cavity has a length L1, and the sampling element has a length L2, where L1 ≥ L2.
15. The biopsy assembly of claim 1, wherein, The pressure regulating channel has a diameter D, which is ≤0.5mm.
16. The biopsy assembly of claim 1, wherein, The cap has a large end and a small end, and the cap gradually decreases in size from the large end to the small end.
17. The biopsy assembly of claim 16, wherein, Both the sampling element and the first opening are located on the central axis of the cap body, and the first opening is located at the small end.
18. The biopsy assembly of any of claims 1 to 17, wherein, The sampling component and the central axis of the cap body have a first angle, which is 0° to 180°.
19. The biopsy assembly of any of claims 1 to 17, wherein, There is a second angle between the central axis of the receiving cavity and the central axis of the cap body, the second angle being 0° to 60°.
20. The biopsy assembly of any of claims 1 to 17, wherein, The cross-section of the receiving cavity is circular.
21. An ultrasonic microprobe, characterized by, The device includes a probe body, an ultrasonic transducer, and a biopsy assembly as described in any one of claims 1-20, wherein the biopsy assembly is disposed at the distal end of the probe body, the ultrasonic transducer is disposed within the probe body, wherein the ultrasonic transducer has an emitting surface that emits ultrasonic waves to form an ultrasonic imaging region, and the biopsy assembly is located within the ultrasonic imaging region.
22. The ultrasonic microprobe of claim 21, wherein, The biopsy assembly is detachably connected to the probe body.
23. The ultrasonic microprobe of claim 22, wherein, A fixing part is provided at the end of the cap body away from the first opening, and a fixing fitting part is provided at the distal end of the probe body, and the fixing part is connected to the fixing fitting part.
24. The ultrasonic microprobe of claim 23, wherein, The fixing part is threadedly connected to the fixing mating part.
25. The ultrasonic microprobe of claim 21, wherein, The emitting surface and the central axis of the probe body are at an angle α, where the angle α is 0° to 90°.
26. The ultrasonic microprobe of claim 21, wherein, The ultrasonic transducer is rotatable about the central axis of the probe body or retractable along the central axis of the probe body.
27. An endoscopic ultrasound, characterized in that, The endoscope comprises a host, an endoscope body and an ultrasonic microprobe as claimed in any one of claims 21-26, the endoscope body has a forceps channel, the ultrasonic microprobe at least partially passes through the forceps channel into a cavity to be detected, and the ultrasonic microprobe is electrically connected to the host.
