Ultrasonic biopsy device

Abstract

The present invention relates to the field of medical device technology, and in particular, to an ultrasonic biopsy device. The ultrasonic biopsy device comprises: a needle tube, comprising an inner cavity and provided with an opening in communication with the exterior at one end; and a needle core, passing through the inner cavity of the needle tube. One end of the needle core is provided with a brush section, several cell brush bundles are arranged along the brush section, and the brush section is capable of extending out of the needle tube through the opening. In view of the technical problem that the existing ultrasonic biopsy sampling method has defects, the present invention can first puncture the lesion by means of the needle tube in use to establish a movable channel in the lesion for the needle core, and then can repeatedly rub the lesion with the cell brushes by means of pushing and pulling a connecting cap arranged at one end of the needle core, such that more tissue fluid exudes from the lesion or more tissue debris falls off from the lesion. The cell brush can also perform collection and sampling well, thereby collecting sufficient lesion samples to facilitate pathological analysis.

Description

Ultrasonic biopsy instruments Technical Field

[0001] This invention relates to the field of medical device technology, specifically to an ultrasonic biopsy device. Background Technology

[0002] Endoscopic ultrasound biopsy is a technique that uses an ultrasonic puncture needle to penetrate the wall of the gastrointestinal tract during endoscopic ultrasound examination. The routine procedure involves advancing a thin needle into the lesion to obtain a tissue sample for pathological analysis and biopsy.

[0003] Different lesion tissues in different lesion states have different structural states. Existing ultrasound-guided puncture techniques can generally handle lesions with large amounts of tissue fluid exudation and loose structures, making it relatively easy to collect tissue samples. However, some lesions do not have a large amount of exudate, and their overall structure is relatively compact. After puncture, the puncture needle can only create a local hole, which cannot further promote the exudation of tissue fluid or the shedding of lesion tissue. As a result, current biopsy methods can hardly collect tissue samples, and the inability to obtain sufficient sample volume makes it difficult to meet the needs of pathological analysis. Summary of the Invention

[0004] To address the technical problems of existing ultrasound biopsy sampling methods, this invention also provides an endoscopic ultrasound biopsy instrument. In use, the lesion tissue is first punctured with a needle to create a channel for movement within the lesion tissue. Then, by pushing and pulling the connecting cap, the cell brush can repeatedly rub the lesion tissue, causing more tissue fluid to seep out or more tissue structures to fall off. The cell brush can also effectively collect samples, thereby collecting sufficient lesion samples for pathological analysis.

[0005] The technical solution provided by this invention is as follows: an endoscopic ultrasound biopsy instrument, comprising a handle mechanism, a needle tube, a needle core, and a Luer seat; the Luer seat is detachably disposed at one end of the handle mechanism, the needle tube is connected to the Luer seat and / or the handle mechanism, the other end of the needle tube extends outward from the other end of the handle mechanism, the needle tube is hollow inside, and the needle tube communicates with the Luer seat; a connecting cap is fixedly disposed at one end of the needle core, the connecting cap is sleeved on the outside of the Luer seat and movably cooperates with the Luer seat, the needle core penetrates the inner cavity of the Luer seat and the needle tube; the end of the needle tube opposite to the Luer seat is provided with an opening communicating with the outside, the end of the needle core is provided with a brush segment, and a plurality of bundles of cell brushes are provided along the brush segment, the length of the needle core is greater than the length of the needle tube, so that the brush segment extends out of the needle tube through the opening.

[0006] Optionally, the handle mechanism includes a central rod comprising adjacent first and second segments; a first sliding sleeve is sleeved on the outer side of the first segment, the Luer seat is disposed at one end of the first sliding sleeve, and a first locking element is disposed between the first sliding sleeve and the first segment; a second sliding sleeve is sleeved on the outer side of the second segment, an outer sheath is fixedly disposed at the end of the second segment, an exit sleeve is fixedly disposed at the end of the second sliding sleeve, the exit sleeve is sleeved on the outer side of the outer sheath, the outer sheath is sleeved on the outer side of the needle tube, and a second locking element is disposed between the second sliding sleeve and the second segment.

[0007] Optionally, at least one of the first segment, the second segment, and the Luer seat is provided with scale markings.

[0008] Optionally, the Luer seat and the handle mechanism are connected by a snap-fit ​​connection.

[0009] Optionally, the device further includes a protective sleeve, one end of which is fixedly provided with an assembly end block. The assembly end block is constrained within the handle mechanism by the Luer seat, and the needle tube passes through the assembly end block so that the protective sleeve is fitted onto the outside of the needle tube. A snap-fit ​​cavity is provided within the assembly end block, and an elastic ring is provided at the end of the snap-fit ​​cavity opposite to the Luer seat. A boss is fixedly provided on the needle tube, and the snap-fit ​​cavity is used to accommodate the boss. When the boss is located within the snap-fit ​​cavity, the elastic ring is used to restrict the boss from moving away from the Luer seat. The distance between the boss and the needle tip of the needle tube is less than or equal to the length of the protective sleeve.

[0010] Optionally, adjacent cell bristles along the length of the bristle segment are aligned or staggered.

[0011] Optionally, there is a spacing a between the cell brushes that can overlap after being bent over along the axial direction of the needle core. The spacing a is greater than half the length of a single bundle of cell brushes and less than the length of a single bundle of cell brushes.

[0012] Optionally, the diameter of the brush segment is smaller than the diameter of the needle core.

[0013] Optionally, the brush segment is provided with a plurality of grooves, which are used to accommodate adjacent fallen cell brushes when the cell brushes are flattened.

[0014] Optionally, the length of the cell brush gradually decreases from the end of the needle core toward the connecting cap.

[0015] Optionally, the length of the cell brush gradually decreases from both ends of the brush segment toward the middle.

[0016] Optionally, a scraping portion is provided on the brush segment and / or on the needle core near the brush segment.

[0017] Optionally, the end of the needle core is provided with a spike end.

[0018] Optionally, the cell brush is made of a polymer material.

[0019] Compared with the prior art, the technical solution provided by this invention has the following beneficial effects: In view of the technical problems of the defects in the existing ultrasound biopsy sampling methods, this invention can first puncture the lesion tissue with a needle to open up a channel for movement in the lesion tissue. Then, by pushing and pulling the connecting cap, the cell brush can repeatedly rub the lesion tissue, causing more tissue fluid to seep out or more tissue structures to fall off. The cell brush can also collect samples well, thereby collecting enough lesion samples for pathological analysis.

[0020] To address the technical problems of existing ultrasonic biopsy sampling instruments, this invention also provides an ultrasonic biopsy needle. After the needle punctures the lesion tissue, it can repeatedly rub the lesion tissue by manipulating a cell brush, causing it to exude more tissue fluid or shed more tissue structures. The cell brush can also effectively collect samples, thereby collecting sufficient lesion samples for pathological analysis.

[0021] The technical solution provided by this invention is as follows: an ultrasonic biopsy needle, comprising a handle, a needle core, and a needle tube; the needle tube extends outward from one end of the handle, and a Luer connector is fixedly provided at the other end of the handle, the Luer connector communicating with the needle tube; a needle cap is fixedly provided at one end of the needle core, the diameter of the needle core is smaller than the inner diameter of the needle tube, the needle core passes through the Luer connector, the handle, and the needle tube, and the needle cap is movably engaged with the Luer connector; the length of the needle core is greater than the length of the needle tube, a brush segment is provided near the end of the needle core, and a plurality of clusters of cell brushes are provided along the length direction of the brush segment, with adjacent cell brushes arranged aligned or staggered.

[0022] Optionally, there is a spacing a between the cell brushes that can overlap after being bent over along the axial direction of the needle core. The spacing a is greater than half the length of a single cluster of cell brushes and less than the length of a single cluster of cell brushes.

[0023] Optionally, the diameter of the brush segment is smaller than the diameter of the needle core.

[0024] Optionally, the brush segment is provided with a plurality of grooves, which are used to accommodate adjacent fallen cell brushes when the cell brushes are flattened.

[0025] Optionally, n brush rings are continuously arranged along the length of the brush segment, and the brush rings are composed of several cell brushes distributed around the circumference of the needle core.

[0026] Optionally, the cellular bristles on the brush segment are arranged in a spiral shape.

[0027] Optionally, the length of the cell brush gradually decreases from the end of the needle core toward the needle cap.

[0028] Optionally, the length of the cell brush gradually decreases from both ends of the brush segment toward the middle.

[0029] Optionally, the cell brush is made of a polymer material.

[0030] Compared with the prior art, the technical solution provided by this invention has the following beneficial effects: In view of the technical problems of defects in existing ultrasonic biopsy sampling instruments, this invention can repeatedly rub the lesion tissue by manipulating the cell brush after the needle punctures the lesion tissue, so that more tissue fluid is exuded or more tissue structures are shed. The cell brush can also collect samples well, thereby collecting enough lesion samples for pathological analysis.

[0031] To address the technical problems of existing ultrasonic puncture techniques, this invention provides an ultrasonic biopsy instrument. After the needle punctures the lesion tissue, the instrument can repeatedly rub and damage the lesion tissue by pushing and pulling the needle core, causing more tissue fluid to seep out or more tissue structures to fall off, thereby collecting sufficient lesion samples for pathological analysis.

[0032] The technical solution provided by this invention is as follows: an ultrasonic biopsy instrument, comprising a handle, a needle tube, a Luer connector, and a needle core; the needle tube extends outward from one end of the handle, the Luer connector is disposed at the other end of the needle tube and communicates with the needle tube, a mating cap is fixedly disposed at one end of the needle core, the needle core passes through the Luer connector, the handle, and the needle tube, and the mating cap is movably mated with the Luer connector; a brush section is provided at the end of the needle core, a plurality of bundles of cell brushes are provided on the brush section, and a scraping part is provided on the brush section and / or on the needle core near the brush section.

[0033] Optionally, the scraping portion is disposed in the area of ​​the brush segment near the end of the needle core.

[0034] Optionally, the scraping portion is disposed between the cell brushes.

[0035] Optionally, the scraping part is a rough, abrasive surface on the needle core.

[0036] Optionally, the scraping part is composed of a plurality of raised burrs disposed on the needle core.

[0037] Optionally, there is a spacing 'a' between the cell brushes that can overlap after being bent over along the axial direction of the needle core. The spacing 'a' is greater than half the length of a single cluster of cell brushes and less than the length of a single bundle of cell brushes.

[0038] Optionally, the Luer connector is provided with a scale.

[0039] Optionally, the end of the needle core is provided with a spike.

[0040] Optionally, the cell brush is made of a polymer material.

[0041] Compared with the prior art, the technical solution provided by this invention has the following beneficial effects: In view of the technical problems of the defects of the existing ultrasonic puncture technology, this invention can, after the needle punctures the lesion tissue, use the push and pull of the needle core to make the cell brush and scraping part repeatedly rub and damage the lesion tissue at the same time, so as to cause more tissue fluid to seep out or more tissue structures to fall off, thereby collecting enough lesion samples for pathological analysis.

[0042] The present invention also provides a technical solution: an ultrasonic biopsy device, comprising: a needle tube, which is hollow inside and has an opening at one end communicating with the outside; and a needle core, which penetrates the inner cavity of the needle tube, wherein a brush segment is provided at one end of the needle core, and a plurality of bundles of cell brushes are provided along the brush segment, wherein the brush segment can extend out of the needle tube through the opening.

[0043] Optionally, adjacent cell bristles along the length of the bristle segment are aligned or staggered.

[0044] Optionally, there is a spacing a between the cell brushes that can overlap after being bent over along the axial direction of the needle core. The spacing a is greater than half the length of a single bundle of cell brushes and less than the length of a single bundle of cell brushes.

[0045] Optionally, the diameter of the brush segment is smaller than the diameter of the needle core.

[0046] Optionally, the brush segment is provided with a plurality of grooves, which are used to accommodate adjacent fallen cell brushes when the cell brushes are flattened.

[0047] Optionally, the length of the cell brush gradually decreases from one end of the needle core to the other end of the connecting cap.

[0048] Optionally, the length of the cell brush gradually decreases from both ends of the brush segment toward the middle.

[0049] Optionally, n brush rings are continuously arranged along the length of the brush segment, and the brush rings are composed of several cell brushes distributed around the circumference of the needle core.

[0050] Optionally, the cellular bristles on the brush segment are arranged in a spiral shape.

[0051] Optionally, the ultrasound biopsy instrument further includes: a handle mechanism; and a Luer seat detachably disposed at one end of the handle mechanism, wherein the needle tube is connected to and communicates with the Luer seat and / or the handle mechanism, and the other end of the needle tube extends outward from the other end of the handle mechanism.

[0052] Optionally, the connecting cap is fitted onto the outside of the Luer seat and movably engages with the Luer seat, and the needle core penetrates the inner cavity of the Luer seat and the needle tube.

[0053] Optionally, the handle mechanism includes a central rod comprising an adjacent first segment and a second segment. A first sliding sleeve is sleeved on the outer side of the first segment. A Luer seat is disposed at one end of the first sliding sleeve. A first locking element is disposed between the first sliding sleeve and the first segment. A second sliding sleeve is sleeved on the outer side of the second segment. An outer sheath is fixedly disposed at the end of the second segment. An exit sleeve is fixedly disposed at the end of the second sliding sleeve. The exit sleeve is sleeved on the outer side of the outer sheath. The outer sheath is sleeved on the outer side of the needle tube. A second locking element is disposed between the second sliding sleeve and the second segment.

[0054] Optionally, at least one of the first segment, the second segment, and the Luer seat is provided with scale markings.

[0055] Optionally, the Luer seat and the handle mechanism are connected by a snap-fit ​​connection.

[0056] Optionally, the ultrasonic biopsy instrument further includes: a protective sleeve, one end of which is fixedly provided with an assembly end block, the assembly end block being constrained within the handle mechanism by the Luer seat, the needle tube passing through the assembly end block so that the protective sleeve is fitted onto the outside of the needle tube, wherein the assembly end block is provided with a snap-fit ​​cavity, the end of the snap-fit ​​cavity opposite to the Luer seat is provided with an elastic ring, the needle tube is fixedly provided with a boss, the snap-fit ​​cavity is used to accommodate the boss, when the boss is located in the snap-fit ​​cavity, the elastic ring is used to restrict the boss from moving away from the Luer seat, and wherein the distance between the boss and the needle tip of the needle tube is less than or equal to the length of the protective sleeve.

[0057] Optionally, a scraping portion is provided on the brush segment and / or on the needle core near the brush segment.

[0058] Optionally, the scraping portion is disposed in the area of ​​the brush segment near the end of the needle core.

[0059] Optionally, the scraping portion is disposed between the cell brushes.

[0060] Optionally, the scraping part is a rough, abrasive surface on the needle core.

[0061] Optionally, the scraping part is composed of a plurality of raised burrs disposed on the needle core.

[0062] Optionally, the end of the needle core is provided with a spike end.

[0063] Optionally, the cell brush is made of a polymer material.

[0064] Compared with the prior art, the technical solution provided by this invention has the following beneficial effects: In view of the technical problems of the defects in the existing ultrasound biopsy sampling methods, this invention can first puncture the lesion tissue with a needle to open up a channel for movement in the lesion tissue. Then, by pushing and pulling the connecting cap, the cell brush can repeatedly rub the lesion tissue, causing more tissue fluid to seep out or more tissue structures to fall off. The cell brush can also collect samples well, thereby collecting enough lesion samples for pathological analysis. Attached Figure Description

[0065] Figure 1 shows one embodiment of the ultrasonic endoscopic biopsy instrument structure proposed in Embodiment 1 of the present invention.

[0066] Figure 2 is a front view of the embodiment shown in Figure 1.

[0067] Figure 3 is an enlarged schematic diagram of point A in Figure 2.

[0068] Figure 4 is a cross-sectional view of the embodiment shown in Figure 1.

[0069] Figure 5 is a partial enlarged view of the cross-sectional view in Figure 4.

[0070] Figure 6 shows a second embodiment of the ultrasonic endoscopic biopsy instrument structure proposed in Embodiment 1 of the present invention.

[0071] Figure 7 is a schematic diagram of the needle core proposed in Embodiment 1 of the present invention.

[0072] Figure 8 is one of the structural schematic diagrams of the brush segment proposed in Embodiment 1 of the present invention.

[0073] Figure 9 is a second schematic diagram of the structure of the brush segment proposed in Embodiment 1 of the present invention.

[0074] Figure 10 is a third schematic diagram of the structure of the brush segment proposed in Embodiment 1 of the present invention.

[0075] Figure 11 is the fourth structural schematic diagram of the brush segment proposed in Embodiment 1 of the present invention.

[0076] Figure 12 is the fifth schematic diagram of the structure of the brush segment proposed in Embodiment 1 of the present invention.

[0077] Figure 13 is a schematic diagram of the cell brush lying down according to Embodiment 1 of the present invention.

[0078] Figure 14 is an exploded view of the structure of the endoscopic ultrasound biopsy instrument proposed in Embodiment 1 of the present invention.

[0079] Figure 15 is a schematic diagram of the extraction process of the ultrasonic endoscopic biopsy instrument structure proposed in Embodiment 1 of the present invention.

[0080] Figure 16 is one of the structural schematic diagrams of the ultrasonic biopsy needle proposed in Embodiment 2 of the present invention.

[0081] Figure 17 is a second schematic diagram of the structure of the ultrasonic biopsy needle proposed in Embodiment 2 of the present invention.

[0082] Figure 18 is a schematic diagram of the needle core and needle tube according to Embodiment 2 of the present invention.

[0083] Figure 19 is a schematic diagram of the needle core proposed in Embodiment 2 of the present invention.

[0084] Figure 20 shows one embodiment of the brush segment proposed in Embodiment 2 of the present invention.

[0085] Figure 21 is a schematic diagram of the cell brushes that have collapsed, corresponding to Figure 20.

[0086] Figure 22 shows a second embodiment of the brush segment proposed in Embodiment 2 of the present invention.

[0087] Figure 23 is a schematic diagram of the cell brushes that have collapsed, corresponding to Figure 22.

[0088] Figure 24 shows a third embodiment of the brush segment proposed in Embodiment 2 of the present invention.

[0089] Figure 25 is a schematic diagram of the cell brushes that have collapsed, corresponding to Figure 24.

[0090] Figure 26 shows the fourth implementation of the brush segment proposed in Embodiment 2 of the present invention.

[0091] Figure 27 shows the fifth embodiment of the brush segment proposed in Embodiment 2 of the present invention.

[0092] Figure 28 is a schematic diagram of the extraction process of the ultrasonic biopsy needle proposed in Embodiment 2 of the present invention.

[0093] Figure 29 is one of the structural schematic diagrams of the ultrasonic biopsy instrument proposed in Embodiment 3 of the present invention.

[0094] Figure 30 is a second schematic diagram of the structure of the ultrasonic biopsy instrument proposed in Embodiment 3 of the present invention.

[0095] Figure 31 is a schematic diagram of the needle core and needle tube according to Embodiment 3 of the present invention.

[0096] Figure 32 is a schematic diagram of the needle core proposed in Embodiment 3 of the present invention.

[0097] Figure 33 shows one embodiment of the brush segment proposed in Embodiment 3 of the present invention.

[0098] Figure 34 shows a second embodiment of the brush segment proposed in Embodiment 3 of the present invention.

[0099] Figure 35 shows a third embodiment of the brush segment proposed in Embodiment 3 of the present invention.

[0100] Figure 36 is a schematic diagram of the ultrasonic biopsy instrument extraction process proposed in Embodiment 3 of the present invention. Detailed Implementation

[0101] To further understand the content of this invention, a detailed description of the invention will be provided in conjunction with the accompanying drawings and embodiments.

[0102] The present application will now be described in further detail with reference to the accompanying drawings and embodiments. It is understood that the specific embodiments described herein are merely illustrative of the invention and not intended to limit it. Furthermore, it should be noted that, for ease of description, only the parts relevant to the invention are shown in the accompanying drawings. The terms "first," "second," etc., used in this invention are for the convenience of describing the technical solutions of the invention and have no specific limiting effect; they are all general terms and do not constitute a limitation on the technical solutions of the invention. It should be noted that, in the absence of conflict, the embodiments and features in the embodiments of this application can be combined with each other. In the description of this invention, it should be noted that the terms "center," "upper," "lower," "left," "right," "vertical," "horizontal," "inner," and "outer," etc., indicate the orientation or positional relationship based on the orientation or positional relationship shown in the accompanying drawings, and are only for the convenience of describing the invention and simplifying the description, not to indicate or imply that the device or element referred to must have a specific orientation, or be constructed and operated in a specific orientation, and therefore should not be construed as a limitation of the invention. In addition, the terms "first," "second," and "third" are used for descriptive purposes only and should not be construed as indicating or implying relative importance. Unless otherwise explicitly specified and limited, the terms "installation," "connection," and "linking" should be interpreted broadly. For example, they can refer to fixed connections, detachable connections, or integral connections; they can refer to mechanical connections or electrical connections; they can refer to direct connections or indirect connections through an intermediate medium; and they can refer to the internal connection between two components. Those skilled in the art can understand the specific meaning of the above terms in this invention based on the specific circumstances. Multiple technical solutions in the same embodiment, as well as multiple technical solutions in different embodiments, can be arranged and combined to form new technical solutions that do not contradict or conflict, all of which are within the scope of protection claimed by this invention.

[0103] Example 1

[0104] Referring to Figures 1 to 15, this embodiment proposes an endoscopic ultrasound biopsy instrument, including a handle mechanism 1, a needle tube 2, a needle core 3, and a Luer seat 4. The Luer seat 4 is detachably mounted at one end of the handle mechanism 1. The needle tube 2 is connected to the Luer seat 4 and / or the handle mechanism 1. The other end of the needle tube 2 extends outward from the other end of the handle mechanism 1. The needle tube 2 is hollow and communicates with the Luer seat 4. A connecting cap 5 is fixedly mounted at one end of the needle core 3. The connecting cap 5 is fitted onto the outside of the Luer seat 4 and movably engages with the Luer seat 4. The needle core 3 penetrates the inner cavities of the Luer seat 4 and the needle tube 2. An opening communicating with the outside is provided at the end of the needle tube 2 facing away from the Luer seat 4. A brush section 30 is provided at the end of the needle core 3, along which several bundles of cell brushes 6 are arranged. The length of the needle core 3 is greater than the length of the needle tube 2, so that the brush section 30 extends outward from the needle tube 2 through the opening.

[0105] The operating principle of the endoscopic ultrasound biopsy instrument in this embodiment is as follows: First, the needle tube 2 is inserted into the forceps channel of the endoscopic ultrasound. Based on the imaging of the endoscopic ultrasound, the needle tip of the needle tube 2 is inserted into the lesion tissue. If the lesion tissue structure is relatively loose and a lot of tissue fluid oozes out after puncture, the connecting cap 5 can be pushed and pulled several times, and the tissue fluid or tissue structure can be brushed and collected by the cell brush 6 at the end of the needle core 3.

[0106] If the diseased tissue does not have a large amount of exudate and the overall structure is relatively compact, the connecting cap 5 can be pushed and pulled repeatedly, so that the cell brush 6 repeatedly rubs the diseased tissue, causing the diseased tissue to be rubbed and destroyed, thereby causing more tissue structure to fall off or more tissue fluid to exude. While the cell brush 6 repeatedly rubs the diseased tissue, a large amount of detached tissue structure and tissue fluid will also adhere to the cell brush 6.

[0107] Once sufficient lesion tissue samples have been collected on the cell brush 6, the endoscopic ultrasound biopsy instrument of this embodiment offers two methods for obtaining tissue samples: one method is to directly remove the needle core 3, i.e., by directly pulling the connecting cap 5, the needle core 3 is extracted separately from the ultrasound biopsy instrument. In this case, the lesion tissue remaining on the cell brush 6 will be removed along with the needle core 3.

[0108] Another method is to use a negative pressure device for aspiration. In the embodiment shown in Figure 15, for example, a two-way Lur seat 4 is used. After the needle core 3 is removed, the Lur seat 4 can be directly connected to a negative pressure device such as a syringe to aspirate the lesion tissue. Similarly, in the embodiment shown in Figure 6, a three-way Lur seat 4 is used. In this case, the needle core 3 does not need to be removed, and the syringe can be directly connected to the additional connecting port of the Lur seat 4 to achieve aspiration. Furthermore, when using the three-way Lur seat 4, the needle core 3 can be repeatedly pushed and pulled to continue scraping the lesion tissue, thereby continuously generating new sloughed lesion tissue for aspiration. The connection between the needle tube 2 and the Lur seat 4 and / or the handle mechanism means that the connection between the needle tube 2 and the Lur seat 4 can be that the needle tube 2 is directly led out from the Lur seat 4 (i.e., the needle tube 2 is directly connected to the Lur seat 4); or, the needle tube 2 can also be connected to the Lur seat 4 through the cavity or tube inside the handle mechanism 1.

[0109] As can be seen from the aforementioned operation method, the cell brush 6 in this embodiment can be removed separately along with the needle core 3, greatly increasing the convenience of surgical operations and allowing for flexible handling of different sampling scenarios. If the same patient needs to be sampled multiple times at different lesion locations, or if a single sampling cannot meet the sampling requirements, multiple repeated samplings can be achieved by replacing the needle core 3 without removing the needle tube 2 (which can also be understood as the instrument sheath 14, or such as the endoscopic forceps channel, or other instrument channels into the human body), greatly saving sampling time.

[0110] Similarly, since the Luer seat 4 is detachably mounted on one end of the handle mechanism 1, and the needle tube 2 is connected to the Luer seat 4, the needle tube 2 and the needle core 3 can be removed together by directly removing the Luer seat 4, and a new needle tube 2 and needle core 3 can be replaced on the Luer seat 4 and then reinstalled on the handle mechanism 1 to achieve multiple sampling similar to the above situation.

[0111] In this embodiment, the cell brush 6 can be made of polymer materials including, but not limited to, nylon, polyester, and silicone. Based on practical experience, another advantage of setting the cell brush 6 at the end of the needle core 3 in this embodiment is that, since ultrasound biopsy technology uses an ultrasound endoscope, its imaging clarity for small objects is not very high due to its working principle. However, by setting the cell brush 6 at the end of the needle core 3, the volume of the end of the needle core 3 is increased, thus expanding the reflective area of ​​the end of the needle core 3, making the observability of the end of the needle core 3 more excellent, thereby improving sampling accuracy.

[0112] In some embodiments, the maneuverability of the endoscopic ultrasound biopsy instrument can be improved by modifying the handle mechanism 1. For example, the handle mechanism 1 can be designed as follows: Referring to Figures 2 and 4, the handle mechanism 1 includes a central rod 10, which includes an adjacent first segment 101 and a second segment 102; a first sliding sleeve 11 is sleeved on the outer side of the first segment 101, a Luer seat 4 is disposed at one end of the first sliding sleeve 11, and a first locking member 13 is disposed between the first sliding sleeve 11 and the first segment 101; a second sliding sleeve 12 is sleeved on the outer side of the second segment 102, an outer sheath 14 is fixedly disposed at the end of the second segment 102, an exit sleeve 15 is fixedly disposed at the end of the second sliding sleeve 12, the exit sleeve 15 is sleeved on the outer side of the outer sheath 14, the outer sheath 14 is sleeved on the outer side of the needle tube 2, and a second locking member 16 is disposed between the second sliding sleeve 12 and the second segment 102.

[0113] In this embodiment, the purpose of setting the outer sheath 14 is to avoid damage to the forceps channel during the insertion of the needle tube 2 and the needle core 3 into the ultrasonic endoscope forceps channel. The handle mechanism 1 can perform the following functions: (1) adjusting the extension length of the outer sheath 14; (2) adjusting the extension length of the needle tube 2.

[0114] Regarding the adjustment of the extension length of the outer sheath tube 14, the working principle is as follows: with the intermediate rod 10 as a stationary reference, the outer sheath tube 14 will not move relative to the intermediate rod 10 (i.e., the second segment 102), while the second sliding sleeve rod 12 can slide relative to the outer sheath tube 14. The sliding of the second sliding sleeve rod 12 will drive the movement of the lead-out sheath 15, thereby realizing the movement of the outer sheath tube 14 relative to the lead-out sheath 15. Thus, the length of the outer sheath tube 14 exposed outside the handle mechanism 1 is adjusted.

[0115] After the position of the second sliding sleeve 12 is adjusted, the second locking member 16 can lock the position of the second sliding sleeve 12, thereby preventing the second sliding sleeve 12 from moving freely. As shown in Figure 4, the second locking member 16 can be a locking screw. Rotating the locking screw so that the end of the locking screw abuts against the outer wall of the intermediate rod 10 can play a limiting role.

[0116] In this embodiment, the lead-out sleeve 15 is also provided to extend the contact area between the second sliding sleeve and the outer sheath 14, so as to avoid excessive bending of the outer sheath 14, which would lead to stress concentration and damage.

[0117] Regarding the adjustment of the extension length of the needle tube 2, the working principle is as follows: with the intermediate rod 10 as a stationary reference, the Luer seat 4 is set on the first sliding sleeve rod 11. Therefore, when the first sliding sleeve rod 11 slides relative to the intermediate rod 10 (i.e. the first segment 101), it actually changes the positional relationship of the needle tube 2 relative to the intermediate rod 10, that is, it changes the length of the needle tube 2 exposed outside the handle mechanism 1.

[0118] Similar to the aforementioned second sliding sleeve 12, after the position of the first sliding sleeve 11 is adjusted, the first locking member 13 can lock the position of the first sliding sleeve 11, thereby preventing the first sliding sleeve 11 from moving freely. As shown in Figures 2 and 4, the first locking member 13 can be a locking screw. Rotating the locking screw so that the end of the locking screw abuts against the outer wall of the intermediate rod 10 can achieve a limiting effect.

[0119] Because of the position adjustment of the outer sheath 14, needle tube 2 and needle core 3, in order to accurately position them, in a further embodiment, scale marks can be provided on the first segment 101, the second segment 102 and the Luer seat 4 to determine their respective movement positions.

[0120] In this embodiment, the Luer seat 4 and the handle mechanism 1 are detachable, preferably using a snap-fit ​​connection. The specific snap-fit ​​connection configuration is not limited. Taking Figure 5 as an example, a snap-fit ​​can be provided on the Luer seat 4, and a step can be provided on the handle mechanism 1. The snap-fit ​​engages with the step, thus achieving the snap-fit ​​connection between the Luer seat 4 and the handle mechanism 1.

[0121] As can be seen from the aforementioned embodiments, the needle tube 2 can be pulled out. However, due to its long length, the needle tip may swing wildly during withdrawal, potentially causing injury to medical personnel or patients. To avoid this problem, in a preferred embodiment, as shown in Figures 5, 7, and 14, the endoscopic ultrasound biopsy instrument also includes a protective sleeve 70. One end of the protective sleeve 70 is fixedly fitted with an assembly end block 71, which is constrained within the handle mechanism 1 by a Luer seat 4. The needle tube 2 passes through the assembly end block 71 so that the protective sleeve 70 is fitted onto the outside of the needle tube 2. A locking cavity 710 is provided within the assembly end block 71. An elastic ring 73 is provided at the end of the locking cavity 710 facing away from the Luer seat 4. A boss 31 is fixedly provided on the needle tube 2, and the locking cavity 710 accommodates the boss 31. When the boss 31 is located within the locking cavity 710, the elastic ring 73 restricts the boss 31 from moving away from the Luer seat 4.

[0122] In this implementation, when the Luer seat 4 is removed, the assembly end block 71 loses its limiting position. As the needle tube 2 is gradually pulled out of the endoscopic ultrasound biopsy instrument, the protrusion 31 on the needle tube 2 will embed into the assembly cavity. The needle tube 2, the assembly end block 71, and the protective sleeve 70 can be pulled out together. However, due to the setting of the elastic ring 73, the protrusion 31 embedded in the assembly cavity will not detach from the assembly cavity. That is, the elastic ring 73 restricts the movement of the protrusion 31 away from the Luer seat 4. Thus, even after the needle tube 2 is withdrawn, the protective sleeve 70 will not move freely relative to the needle tube 2. Since the distance between the protrusion 31 and the needle tip of the needle tube 2 is less than or equal to the length of the protective sleeve 70, it is ensured that the needle tube 2 (especially the needle tip) is always located inside the protective sleeve 70. That is, after the needle tube 2 is withdrawn from the endoscopic ultrasound biopsy instrument, the needle tip will not be exposed, avoiding the potential harm caused by the needle tube 2 swinging around.

[0123] In this embodiment, the layout of the cell brushes 6 can be arbitrary. Generally, they can be arranged in an orderly manner along the brush segment 30, or they can be arranged in an alternating manner. As shown in Figures 8 to 12, there is one layout of the cell brushes 6. There is a certain degree of alternation between adjacent cell brushes 6 along the length direction of the brush segment 30. This can, to a certain extent, prevent the cell brushes 6 from being squeezed against each other when the needle tube 2 is retracted, thereby preventing the collected tissue sample from being squeezed out of the needle tube 2.

[0124] Practical experience shows that even with an alternating arrangement of adjacent cell brushes 6, some cell brushes 6 may still be squeezed together when the needle tube 2 is retracted, causing the collected tissue sample to be squeezed out. Therefore, to preserve the tissue sample on the cell brushes as much as possible, in a preferred embodiment, as shown in Figure 7, there is a spacing 'a' between the cell brushes 6 that can overlap after being bent over along the axial direction of the needle core 3. The spacing 'a' is greater than half the length of a single cluster of cell brushes 6 but less than the length of a single cluster of cell brushes 6. Thus, when the cell brushes 6 are retracted into the needle tube 2, they will overlap to a certain extent, but the degree of squeezing between them is smaller, and appropriate overlap can actually better preserve the tissue sample. Furthermore, since this overlap is not completely overlapping, it occupies less volume and can ensure that there is enough space in the needle tube 2 to accommodate the cell tissue.

[0125] In another embodiment, as shown in Figure 8, the diameter of the brush segment 30 is smaller than the diameter of the needle core 3, that is, the needle core 3 adopts a variable diameter design. In this embodiment, when the brush segment 30 is retracted into the needle tube 2, a relatively larger space will be formed between the brush segment 30 and the needle tube 2, making it easier to collect and sample cells and tissues, and greatly reducing the possibility of cells and tissues falling out of the needle tube 2.

[0126] In other embodiments, as shown in Figure 9, the brush segment 30 is provided with a plurality of grooves 32. When the cell brush 6 is bent over, the grooves 32 are used to accommodate the adjacent bent cell brush 6. In this embodiment, the grooves 32 can be of any shape. The grooves 32 are preferably arranged between the spaced cell brushes 6. When the bristles are inside the needle tube 2, they will naturally bend over in the grooves 32. That is, the grooves 32 play the role of collecting the sampled tissue. On the one hand, this can make the sample volume larger, and on the other hand, it can also ensure that the cell tissue is not easily detached from the needle tube 2 during the sampling process.

[0127] Furthermore, there are other improved implementation methods to minimize tissue sample loss during the process of the cell brush 6 completing sampling and retracting into the needle 2. As shown in Figure 10, the length of the cell brush 6 gradually decreases from the end of the needle core 3 towards the connecting cap 5. This arrangement ensures that when the cell brush 6 retracts into the needle 2, the larger-sized cell brush 6 at the front end can block the tissue, making it less likely to fall out of the needle 2.

[0128] In another similar embodiment, as shown in Figure 11, the length of the cell brush 6 gradually decreases from both ends of the brush segment 30 towards the middle. This design, with its longer cell brush 6, improves the effectiveness of friction sampling and creates a receiving space in the middle of the brush segment 30. When the cell brush 6 furthest from the needle core 3 retracts into the needle tube 2, this portion of the brush will first collapse, lying between the shorter cell brushes 6 in the middle of the brush segment 30. Because the cell brushes 6 in the middle of the brush segment 30 are shorter, they can effectively store the sample. Similar to the aforementioned embodiment, the cell brush 6 closer to the needle core 3 is relatively longer, ensuring that when the cell brush 6 retracts into the needle tube 2, the larger-sized cell brush 6 at the front end can block the cell tissue, making it less likely to detach from the needle tube 2.

[0129] As can be seen from the foregoing embodiments, the presence of the brush in this embodiment is to create friction on the diseased tissue so that more tissue structure is removed. However, since some diseased tissue is too small or dense, the brush is still not enough to scrape off sufficient tissue structure. Therefore, in an improved embodiment, as shown in Figure 12, a scraping part 33 is provided on the brush section 30 and / or the needle core 3 near the brush section 30.

[0130] With the scraping part 33 in place, when the needle core 3 moves, the scraping part 33 and the cell brush 6 at its end will repeatedly scrape the diseased tissue, so that the dense tissue surface layer will gradually peel off and cause a large amount of tissue fluid to seep out.

[0131] The scraping part 33 can be, as shown in Figure 12, a rough abrasive surface on the needle core 3; or it can be composed of several protruding burrs on the needle core 3, so as to easily destroy the diseased tissue and detach the cells.

[0132] Furthermore, the scraping part 33 is preferably located in the area of ​​the brush section 30 near the end of the needle core 3, so that the lesion tissue can be scraped before the cell brush 6 touches the lesion tissue, thus achieving the effect of scraping before collection.

[0133] Alternatively, in another embodiment, the scraping part 33 is disposed between the cell brushes 6, thereby scraping the lesion tissue while the cell brushes 6 are in contact with it. It should be noted that although the needle 2 has been inserted into the lesion tissue, the cell brushes 6 are initially in a folded state due to the relatively dense and compact nature of the lesion tissue. Therefore, the scraping part 33 located between the cell brushes 6 can still contact the lesion tissue and abrade and destroy it. When the destruction reaches a certain extent, the cell brushes 6 and the scraping part 33 can contact the lesion tissue together, thereby achieving effective sampling of the dense lesion tissue.

[0134] In addition, although the needle tube 2 has been inserted into the lesion tissue during sampling, the needle core 3 still needs to move inside the lesion tissue. Therefore, the needle core 3 also needs to be inserted into the lesion tissue. Thus, a spike can be set at the end of the needle core 3 so that the needle core 3 can be inserted into the lesion tissue through the spike.

[0135] In summary, addressing the technical problems of existing ultrasound biopsy sampling methods, the ultrasound endoscopic biopsy instrument proposed in this embodiment first punctures the lesion tissue through the needle tube 2 to create a channel for movement within the lesion tissue using the needle core 3. Subsequently, by pushing and pulling the connecting cap 5, the cell brush 6 can repeatedly rub the lesion tissue, causing more tissue fluid to seep out or more tissue structures to fall off. The cell brush 6 can also effectively collect samples, thereby collecting sufficient lesion samples for pathological analysis.

[0136] Example 2

[0137] Referring to Figures 16 to 28, this embodiment proposes an ultrasonic biopsy needle, including a handle portion 201, a needle core 202, and a needle tube 203. The needle tube 203 extends outward from one end of the handle portion 201, and a Luer connector 204 is fixedly disposed at the other end of the handle portion 201, communicating with the needle tube 203. A needle cap 205 is fixedly disposed at one end of the needle core 202. The diameter of the needle core 202 is smaller than the inner diameter of the needle tube 203. The needle core 202 passes through the Luer connector 204, the handle portion 201, and the needle tube 203, and the needle cap 205 is movably engaged with the Luer connector 204. The length of the needle core 202 is greater than the length of the needle tube 203. A brush segment 2020 is disposed near the end of the needle core 202, and a plurality of clusters of cell brushes 206 are disposed along the length direction of the brush segment 2020, with adjacent cell brushes 206 arranged aligned or staggered.

[0138] In this embodiment, the cell brush 206 at the tip of the needle core 202 extends from the end of the needle tube 203 in its natural state, while the needle cap 205 can move back and forth relative to the Luer connector 204, thereby adjusting the length of the brush section 2020 exposed to the outside. The cell brush 206 can be made of polymer materials including, but not limited to, nylon, polyester, silicone, etc.

[0139] In practical use, different sampling methods can be selected based on the specific lesion tissue condition of the clinical patient. If the lesion tissue is relatively large, the needle core 202 with the cell brush 206 can be removed from the needle tube 203, and only the needle tube 203 can be used for puncture and tissue sampling. If the lesion tissue is relatively small or only suitable for brushing, brushing sampling can be performed using the cell brush 206. After brushing sampling is completed, the cell brush 206 is returned to the needle tube 203, pending pathological analysis.

[0140] For small lesions located outside the digestive tract wall or natural body cavities, the ultrasound biopsy needle of this embodiment can also perform brush sampling. During use, by pulling back the needle cap 205, the cellular brush 206 at the end of the needle core 202 is completely retracted into the needle tube 203. Under the guidance of an endoscopic ultrasound, the needle tube 203 is punctured into the designated lesion. Once the location is fully determined, repeatedly pushing and pulling the needle cap 205 moves the needle core 202, causing the cellular brush 206 to extend outside the needle tube 203 and repeatedly rub against the tissue for sampling. It is conceivable that by repeatedly rubbing the lesion with the cellular brush 206, more lesion tissue can be shed, and more tissue fluid can be generated. The cellular brush 206 can then effectively collect this shed lesion tissue and tissue fluid for sampling. After sampling is completed, the cell brush 206 is retracted into the needle tube 203. Subsequently, the cell brush 206 can be removed separately along with the needle core 202, or it can be withdrawn from the body as a whole along with the rest of the ultrasound biopsy needle, such as the needle tube 203, so that the extracted tissue sample can be subjected to pathological analysis.

[0141] Alternatively, after the lesion tissue has been abrade and destroyed, a negative pressure device such as a syringe can be connected through the Luer connector 204 to directly aspirate the lesion tissue through the pathway formed by the needle tube 203 and the Luer connector 204, thus improving the sampling operation. For example, when using the two-way connector as shown in Figure 16, the needle core 202 can be removed first, and then a negative pressure device such as a syringe can be connected for extraction. Refer to Figure 28 for a schematic diagram of the extraction process using an ultrasonic biopsy needle. Alternatively, as shown in Figure 17, a three-way Luer connector 204 can be used to achieve extraction without removing the needle core 202. In this case, the lesion tissue can be further abraded with the cell brush 206 as extraction progresses to collect more samples. In this embodiment, the connection between the Luer connector 204 and the needle tube 203 specifically means that one end of the pointer tube 203 passes through the inside of the handle portion 201 and is directly connected to the Luer connector 204 to form a connection path, or the needle tube 203 is connected to the Luer connector 204 through a connecting structure such as a tube or cavity inside the handle portion 201.

[0142] Based on practical experience, another advantage of setting a cell brush 206 at the end of the needle core 202 in this embodiment is that, since ultrasound biopsy technology uses an ultrasound endoscope, the imaging clarity for small objects is not very high based on its working principle. However, by setting a cell brush 206 at the end of the needle core 202 in this embodiment, the overall volume of the needle core 202 is increased, making the observability of the end of the needle core 202 more excellent.

[0143] As can be seen from the aforementioned operation method, the cell brush 206 in this embodiment can be removed separately along with the needle core 202, greatly increasing the convenience of surgical operations and allowing for flexible handling of different sampling scenarios. If the same patient needs to be sampled multiple times at different lesion locations, or if a single sampling cannot meet the sampling requirements, the needle core 202 can be replaced without removing the needle tube 203 (which can also be understood as an instrument sheath, or such as an endoscopic forceps channel, or other instrument channels into the human body) from the body, thus greatly saving sampling time.

[0144] In this embodiment, the cell brushes 206 can be arranged in any form, generally in an orderly manner along the brush segment 2020. For example, the cell brushes 206 on the brush segment 2020 can be distributed in a spiral shape to facilitate the friction brushing of diseased tissue.

[0145] Figures 20 and 21 show one arrangement of the cell brush 206. In this embodiment, n brush rings are continuously arranged along the length of the brush segment 2020. Each brush ring is composed of several cell brushes 206 arranged around the circumference of the needle core 202. Adjacent brush rings are staggered to a certain extent to prevent the cell brushes 206 from collapsing and squeezing each other when the needle tube 203 is retracted, thus avoiding the squeezing out of the collected tissue sample.

[0146] Although the adjacent cell brushes 206 are staggered, the spaced cell brushes 206 may still squeeze against each other when the needle tube 203 is retracted, causing the collected tissue sample to be squeezed out. Therefore, in order to preserve the tissue sample on the cell brushes as much as possible, in the preferred embodiment, as shown in Figure 19, there is a spacing 'a' between the cell brushes 206 that can overlap after being bent over along the axial direction of the needle core 202. The spacing 'a' is greater than half the length of a single cluster of cell brushes 206 and less than the length of a single cluster of cell brushes 206. Thus, when the cell brushes 206 are retracted into the needle tube 203, they will have a certain degree of overlap, but the degree of squeezing between them is smaller, and appropriate overlap can better preserve the tissue sample. In addition, since this overlap is not completely overlapping, it occupies less volume and can also ensure that there is enough space in the needle tube 203 to accommodate the cell tissue.

[0147] In another embodiment, as shown in Figures 22 and 23, the diameter of the brush segment 2020 is smaller than the diameter of the needle core 202, that is, the needle core 202 adopts a variable diameter design. In this embodiment, when the brush segment 2020 is retracted into the needle tube 203, a relatively larger space will be formed between the brush segment 2020 and the needle tube 203, making it easier to collect and sample cells and tissues, and greatly reducing the possibility of cells and tissues falling out of the needle tube 203.

[0148] In other embodiments, as shown in Figures 24 and 25, the brush segment 2020 is provided with a plurality of grooves 2021. When the cell brushes 206 are bent over, the grooves 2021 are used to accommodate the adjacent bent cell brushes 206. In this embodiment, the grooves 2021 can be of any shape. The grooves 2021 are preferably arranged between the spaced cell brushes 206. When the bristles are inside the needle tube 203, they will naturally bend over in the grooves 2021. That is, the grooves 2021 play a role in collecting the sampled tissue. On the one hand, this allows for a larger sample volume, and on the other hand, it ensures that the cell tissue is not easily detached from the needle tube 203 during the sampling process.

[0149] Furthermore, other improved implementation methods exist to minimize tissue sample loss during the process of the cell brush 206 completing sampling and retracting into the needle tube 203. As shown in Figure 26, the length of the cell brush 206 gradually decreases from the end of the needle core 202 towards the needle cap 205. This arrangement ensures that when the cell brush 206 retracts into the needle tube 203, the larger-sized cell brush 206 at the front end can block the tissue, making it less likely to detach from the needle tube 203.

[0150] In another similar embodiment, as shown in Figure 27, the length of the cell brush 206 gradually decreases from both ends of the brush segment 2020 towards the middle. This design, with its longer cell brush 206, improves the effectiveness of friction sampling and creates a receiving space in the middle of the brush segment 2020. When the cell brush 206 away from the end of the needle core 202 retracts into the needle tube 203, this portion of the brush will first collapse, lying between the shorter cell brushes 206 in the middle of the brush segment 2020. Because the cell brushes 206 in the middle of the brush segment 2020 are shorter, they can effectively store the sample. Similar to the aforementioned embodiment, the relatively longer cell brush 206 near the end of the needle core 202 ensures that when the cell brush 206 retracts into the needle tube 203, the larger cell brush 206 at the front end can block the cell tissue, making it less likely to detach from the needle tube 203.

[0151] Example 3

[0152] Referring to Figures 29 to 36, this embodiment proposes an ultrasonic biopsy instrument, including a handle 301, a needle tube 302, a Luer connector 303, and a needle core 304. The needle tube 302 extends outward from one end of the handle 301. The Luer connector 303 is located at the other end of the needle tube 302 and communicates with it. A mating cap 305 is fixedly provided at one end of the needle core 304. The needle core 304 passes through the Luer connector 303, the handle 301, and the needle tube 302. The mating cap 305 is movably mated with the Luer connector 303. A brush section 3040 is provided at the end of the needle core 304. Several bundles of cell brushes 306 are provided on the brush section 3040 and / or on the needle core 304 near the brush section 3040. A scraping part 307 is provided on the brush section 3040 and / or on the needle core 304 near the brush section 3040.

[0153] In this embodiment of the ultrasonic biopsy instrument, the tip of the needle tube 302 is used to puncture the lesion tissue. After puncture, the needle core 304 is moved by pushing and pulling the cap 305, so that the needle core 304 moves outside the needle tube 302. When the needle core 304 moves, the scraping part 307 and the cell brush 306 at its end will repeatedly scrape the lesion tissue, so that the dense tissue surface layer is gradually peeled off and detached, and a large amount of tissue fluid is exuded.

[0154] After repeated scraping of the lesion tissue, the ultrasonic biopsy instrument in this embodiment has two methods for obtaining tissue samples: one method is sampling by retaining the sample through the cell brush 306, that is, by directly pulling the matching cap 305, the needle core 304 is directly extracted from the ultrasonic biopsy instrument. At this time, the lesion tissue will remain on the cell brush 306 and will be removed together with the needle core 304.

[0155] Another method involves using a negative pressure device for aspiration. In embodiments shown in Figures 29 and 36, a two-way Luer connector 303 is used. After the needle core 304 is removed, the Luer connector 303 can be directly connected to a negative pressure device, such as a syringe, to aspirate the lesion tissue. Similarly, in an embodiment shown in Figure 30, a three-way Luer connector 303 is used. In this case, the needle core 304 does not need to be removed; the syringe can be directly connected to the additional port of the Luer connector 303 to achieve aspiration. Furthermore, when using the three-way Luer connector 303, the ultrasonic biopsy instrument can continue to repeatedly push and pull the needle core 304 to continue scraping the lesion tissue, thereby continuously generating newly sloughed lesion tissue for sampling.

[0156] As is conceivable, aspirating diseased tissue requires maintaining communication between the needle 302 and the Luer connector 303. In this embodiment, the Luer connector 303 can be connected to the needle 302 via the handle 301. Specifically, the hollow needle 302 is connected to the Luer connector 303 through a connecting structure such as a tube or cavity inside the handle 301. Alternatively, the Luer connector 303 can also pass through the interior of the handle 301 and connect directly to the needle 302, thus forming a communication path.

[0157] As can be seen from the aforementioned operation method, the cell brush 306 in this embodiment can be removed separately along with the needle core 304, greatly increasing the convenience of surgical operations and allowing for flexible handling of different sampling scenarios. If the same patient needs to be sampled multiple times at different lesion locations, or if a single sampling cannot meet the sampling requirements, multiple repeated sampling can be achieved by replacing the needle core 304 without removing the needle tube 302 (which can also be understood as the instrument sheath, or such as the endoscopic forceps channel, or other instrument channels into the human body) from the body, greatly saving sampling time.

[0158] Based on practical experience, another advantage of setting a cell brush 306 at the end of the needle core 304 in this embodiment is that, since ultrasound biopsy technology uses an ultrasound endoscope, the imaging clarity for small objects is not very high based on its working principle. However, by setting a cell brush 306 at the end of the needle core 304 in this embodiment, the volume of the end of the needle core 304 is increased, making the observability of the end of the needle core 304 more excellent.

[0159] In this embodiment, the cell brush 306 can be made of polymer materials including, but not limited to, nylon, polyester, and silicone. The scraping part 307 can be, as shown in Figure 34, a rough abrasive surface on the needle core 304; or, as shown in Figure 36, it can be composed of several protruding burrs provided on the needle core 304, so as to easily destroy the diseased tissue and detach the cell tissue.

[0160] Furthermore, the scraping part 307 is preferably located in the area of ​​the brush section 3040 near the end of the needle core 304, so that the lesion tissue can be scraped before the cell brush 306 touches the lesion tissue, thus achieving the effect of scraping before collection.

[0161] Alternatively, in another embodiment, the scraping part 307 is disposed between the cell brushes 306, thereby scraping the lesion tissue while the cell brushes 306 are in contact with it. It should be noted that although the needle 302 has penetrated the lesion tissue, the cell brushes 306 are initially in a collapsed state due to the relatively dense and compact nature of the lesion tissue. Therefore, the scraping part 307 located between the cell brushes 306 can still contact the lesion tissue and abrade it. When the damage reaches a certain level, the cell brushes 306 and the scraping part 307 can then contact the lesion tissue together, thereby achieving effective sampling of the dense lesion tissue.

[0162] As described above, after sampling, the ultrasonic biopsy instrument in this embodiment retracts the needle core 304 into the needle tube 302. However, during this process, the cell brushes 306 collapse again and are squeezed against the inner wall of the needle tube 302, causing some tissue samples on the cell brushes 306 to be squeezed out. Therefore, to preserve the tissue samples on the cell brushes as much as possible, in a preferred embodiment, as shown in Figure 32, there is a spacing 'a' between the overlapping cell brushes 306 that collapse along the axial direction of the needle core 304. The spacing 'a' is greater than half the length of a single cluster of cell brushes 306 and less than the length of a single bundle of cell brushes 306. Thus, when the cell brushes 306 retract into the needle tube 302, they will overlap to a certain extent, but the degree of compression between them is smaller, and appropriate overlap can better preserve tissue samples. Furthermore, since this overlap is not completely overlapping, it occupies less volume and ensures that there is enough space in the needle tube 302 to accommodate cell tissue, thereby facilitating collection.

[0163] In other preferred embodiments, as shown in Figure 29, the Luer connector 303 is provided with a scale, which makes it easy for the operator to observe the depth of the needle core 304. Since the ultrasonic biopsy instrument of this embodiment is used in conjunction with an ultrasonic endoscope, it can help observe or measure the depth of insertion into the lesion tissue, and can also observe the depth of the lesion tissue in a certain direction by the insertion depth.

[0164] In addition, although the needle 302 has been inserted into the lesion tissue during sampling, the needle core 304 still needs to move inside the lesion tissue. Therefore, the needle core 304 also needs to be inserted into the lesion tissue. Thus, a spike can be set at the end of the needle core 304 to facilitate the insertion of the needle core 304 into the lesion tissue.

[0165] The present invention and its embodiments have been described above illustratively. This description is not restrictive, and the figures shown are only one embodiment of the present invention; the actual structure is not limited thereto. Therefore, if those skilled in the art are inspired by this description and design similar structures and embodiments without departing from the spirit of the present invention, such designs should fall within the protection scope of the present invention.

[0166] This disclosure also includes, but is not limited to, the following technical solutions.

[0167] Technical solution A1. An ultrasonic endoscopic biopsy instrument, characterized in that it includes a handle mechanism (1), a needle tube (2), a needle core (3), and a Luer seat (4);

[0168] The Luer seat (4) is detachably disposed at one end of the handle mechanism (1), the needle tube (2) is connected to the Luer seat (4) and / or the handle mechanism, the other end of the needle tube (2) extends outward from the other end of the handle mechanism (1), the needle tube (2) is hollow inside, and the needle tube (2) is connected to the Luer seat (4).

[0169] A connecting cap (5) is fixedly provided at one end of the needle core (3). The connecting cap (5) is sleeved on the outside of the Luer seat (4) and is movably engaged with the Luer seat (4). The needle core (3) penetrates the inner cavity of the Luer seat (4) and the needle tube (2).

[0170] The needle tube (2) has an opening that communicates with the outside at the end away from the Luer seat (4). The end of the needle core (3) is provided with a brush section (30), and a number of bundles of cell brushes (6) are provided along the brush section (30). The length of the needle core (3) is greater than the length of the needle tube (2) so that the brush section (30) extends out of the needle tube (2) through the opening.

[0171] Technical solution A2. An ultrasonic endoscopic biopsy instrument according to technical solution A1, characterized in that the handle mechanism (1) includes an intermediate rod (10), and the intermediate rod (10) includes an adjacent first segment (101) and a second segment (102);

[0172] A first sliding sleeve rod (11) is sleeved on the outer side of the first segment (101), and the Luer seat (4) is disposed at one end of the first sliding sleeve rod (11). A first locking member (13) is disposed between the first sliding sleeve rod (11) and the first segment (101).

[0173] A second sliding sleeve (12) is sleeved on the outer side of the second segment (102), an outer sheath (14) is fixedly provided at the end of the second segment (102), an exit sleeve (15) is fixedly provided at the end of the second sliding sleeve (12), the exit sleeve (15) is sleeved on the outside of the outer sheath (14), the outer sheath (14) is sleeved on the outside of the needle tube (2), and a second locking member (16) is provided between the second sliding sleeve (12) and the second segment (102).

[0174] Technical solution A3. An endoscopic ultrasound biopsy instrument according to technical solution A2, characterized in that at least one of the first segment (101), the second segment (102) and the Luer seat (4) is provided with scale markings.

[0175] Technical solution A4. An ultrasonic endoscopic biopsy instrument according to technical solution A1, characterized in that the Luer seat (4) and the handle mechanism (1) are snap-fit ​​connected.

[0176] Technical solution A5. An endoscopic ultrasound biopsy instrument according to technical solution A1, characterized in that it further includes a protective sleeve (70), one end of which is fixedly provided with an assembly end block (71), the assembly end block (71) is restricted in the handle mechanism (1) by the Luer seat (4), and the needle tube (2) passes through the assembly end block (71) so that the protective sleeve (70) is sleeved on the outside of the needle tube (2);

[0177] The assembly end block (71) is provided with a snap-fit ​​cavity (710). An elastic ring (73) is provided at the end of the snap-fit ​​cavity (710) away from the Luer seat (4). A boss (31) is fixedly provided on the needle tube (2). The snap-fit ​​cavity (710) is used to accommodate the boss (31). When the boss (31) is located in the snap-fit ​​cavity (710), the elastic ring (73) is used to restrict the boss (31) from moving away from the Luer seat (4).

[0178] The distance between the boss (31) and the needle tip of the needle tube (2) is less than or equal to the length of the protective sleeve (70).

[0179] Technical solution A6. An endoscopic ultrasound biopsy instrument according to technical solution A1, characterized in that the cell brushes (6) adjacent to each other along the length direction of the brush segment (30) are aligned or staggered.

[0180] Technical Solution A7. An endoscopic ultrasound biopsy instrument according to Technical Solution A1, characterized in that there is a gap a between the cell brushes (6) that can overlap after being bent over along the axial direction of the needle core (3), the gap a being greater than half the length of a single bundle of cell brushes (6) and less than the length of a single bundle of cell brushes (6).

[0181] Technical solution A8. An ultrasonic endoscopic biopsy instrument according to technical solution A1, characterized in that the diameter of the brush segment (30) is smaller than the diameter of the needle core (3).

[0182] Technical Solution A9. An endoscopic ultrasound biopsy instrument according to Technical Solution A1, characterized in that a plurality of grooves (32) are provided on the brush segment (30), and when the cell brush (6) is bent over, the grooves (32) are used to accommodate the bent cell brush (6) adjacent to it.

[0183] Technical solution A10. An endoscopic ultrasound biopsy instrument according to technical solution A1, characterized in that the length of the cell brush (6) gradually decreases from the end of the needle core (3) toward the connecting cap (5).

[0184] Technical solution A11. An endoscopic ultrasound biopsy instrument according to technical solution A1, characterized in that the length of the cell brush (6) gradually decreases from both ends of the brush segment (30) toward the middle.

[0185] Technical solution A12. An ultrasonic endoscopic biopsy instrument according to technical solution A1, characterized in that a scraping part (33) is provided on the brush segment (30) and / or on the needle core (3) near the brush segment (30).

[0186] Technical solution A13. An ultrasonic endoscopic biopsy instrument according to technical solution A1, characterized in that the end of the needle core (3) is provided with a spike end (34).

[0187] Technical solution A14. An endoscopic ultrasound biopsy device according to any one of technical solutions A1-A13, characterized in that the cell brush (6) is made of polymer material.

[0188] In addition, this disclosure also includes, but is not limited to, the following technical solutions.

[0189] Technical Solution B1. An ultrasonic biopsy needle, characterized in that it comprises a handle (201), a needle core (202), and a needle tube (203); the needle tube (203) extends outward from one end of the handle (201), and a Luer connector (204) is fixedly provided at the other end of the handle (201), the Luer connector (204) communicating with the needle tube (203);

[0190] A needle cap (205) is fixedly provided at one end of the needle core (202). The diameter of the needle core (202) is smaller than the inner diameter of the needle tube (203). The needle core (202) passes through the Luer connector (204), the handle (201), and the needle tube (203). The needle cap (205) is movably engaged with the Luer connector (204).

[0191] The length of the needle core (202) is greater than the length of the needle tube (203). A brush segment (2020) is provided near the end of the needle core (202). Several clusters of cell brushes (206) are provided along the length direction of the brush segment (2020), and adjacent cell brushes (206) are aligned or staggered.

[0192] Technical solution B2. An ultrasonic biopsy needle according to technical solution B1, characterized in that there is a gap a between the cell brushes (206) that can overlap after being bent over along the axial direction of the needle core (202), the gap a being greater than half the length of a single cluster of cell brushes (206) and less than the length of a single cluster of cell brushes (206).

[0193] Technical solution B3. An ultrasonic biopsy needle according to technical solution B1 or B2, characterized in that the diameter of the brush segment (2020) is smaller than the diameter of the needle core (202).

[0194] Technical Solution B4. An ultrasonic biopsy needle according to Technical Solution B1, characterized in that a plurality of grooves (2021) are provided on the brush segment (2020), and when the cell brush (206) collapses, the grooves (2021) are used to accommodate the adjacent collapsed cell brush (206).

[0195] Technical solution B5. An ultrasonic biopsy needle according to technical solution B1, characterized in that n brush rings are continuously arranged along the length of the brush segment (2020), and the brush rings are composed of a plurality of cell brushes (206) arranged around the circumference of the needle core (202).

[0196] Technical solution B6. An ultrasonic biopsy needle according to technical solution B1, characterized in that the cell brushes (206) on the brush segment (2020) are distributed in a spiral shape.

[0197] Technical solution B7. An ultrasonic biopsy needle according to technical solution B1, characterized in that the length of the cell brush (206) gradually decreases from the end of the needle core (202) toward the needle cap (205).

[0198] Technical solution B8. An ultrasonic biopsy needle according to technical solution B1, characterized in that the length of the cell brush (206) gradually decreases from both ends of the brush segment (2020) toward the middle.

[0199] Technical solution B9. An ultrasonic biopsy needle according to technical solution B1, characterized in that the cell brush (206) is made of polymer material.

[0200] In addition, this disclosure also includes, but is not limited to, the following technical solutions.

[0201] Technical solution C1. An ultrasonic biopsy instrument, characterized in that it includes a handle (301), a needle tube (302), a Luer connector (303), and a needle core (304);

[0202] The needle tube (302) extends outward from one end of the handle (301), the Luer connector (303) is disposed at the other end of the needle tube (302) and the Luer connector (303) communicates with the needle tube (302), one end of the needle core (304) is fixedly provided with a mating cap (305), the needle core (304) passes through the Luer connector (303), the handle (301) and the needle tube (302), and the mating cap (305) is movably mated with the Luer connector (303);

[0203] The end of the needle core (304) is provided with a brush section (3040), and a plurality of bundles of cell brushes (306) are provided on the brush section (3040). A scraping part (307) is provided on the brush section (3040) and / or on the needle core (304) near the brush section (3040).

[0204] Technical solution C2. An ultrasonic biopsy instrument according to technical solution C1, characterized in that the scraping part (307) is disposed in the area of ​​the brush section (3040) near the end of the needle core (304).

[0205] Technical solution C3. An ultrasonic biopsy instrument according to technical solution C1, characterized in that the scraping part (307) is disposed between the cell brushes (306).

[0206] Technical solution C4. An ultrasonic biopsy instrument according to technical solution C1, characterized in that the scraping part (307) is a rough abrasive surface on the needle core (304).

[0207] Technical solution C5. An ultrasonic biopsy instrument according to technical solution C1, characterized in that the scraping part (307) is composed of a plurality of protruding burrs disposed on the needle core (304).

[0208] Technical solution C6. An ultrasonic biopsy instrument according to technical solution C1, characterized in that there is a gap a between the cell brushes (306) that can overlap after being bent over along the axial direction of the needle core (304), the gap a being greater than half the length of a single cluster of cell brushes (306) and less than the length of a single bundle of cell brushes (306).

[0209] Technical solution C7. An ultrasonic biopsy instrument according to technical solution C1, characterized in that the Luer connector (303) is provided with a scale.

[0210] Technical solution C8. An ultrasonic biopsy instrument according to technical solution C1, characterized in that the end of the needle core (304) is provided with a spike.

[0211] Technical solution C9. An ultrasonic biopsy instrument according to technical solution C1, characterized in that the cell brush (306) is made of polymer material.

Claims

1. An ultrasonic biopsy instrument, comprising: The syringe (2) is hollow inside and has an opening at one end that communicates with the outside. as well as The needle core (3) penetrates the inner cavity of the needle tube (2). One end of the needle core (3) is provided with a brush section (30), and several bundles of cell brushes (6) are provided along the brush section (30). The brush section (30) can extend out of the needle tube (2) through the opening.

2. The ultrasonic biopsy device according to claim 1, wherein... The cell brushes (6) that are adjacent to each other along the length of the brush segment (30) are aligned or staggered.

3. The ultrasonic biopsy device according to claim 1 or 2, wherein... There is a gap (a) between the cell brushes (6) that can overlap after being bent over along the axial direction of the needle core (3). The gap (a) is greater than half the length of a single bundle of cell brushes (6) and less than the length of a single bundle of cell brushes (6).

4. The ultrasonic biopsy device according to any one of claims 1 to 3, wherein The diameter of the brush segment (30) is smaller than the diameter of the needle core (3).

5. The ultrasonic biopsy instrument according to any one of claims 1 to 4, wherein... The brush segment (30) is provided with a plurality of grooves (32), which are used to accommodate adjacent fallen cell brushes (6) when the cell brush (6) is flattened.

6. The ultrasonic biopsy device according to any one of claims 1 to 5, wherein The length of the cell brush (6) gradually decreases from one end of the needle core (3) toward the connecting cap (5) fixedly disposed at the other end of the needle core (3).

7. The ultrasonic biopsy device according to any one of claims 1 to 5, wherein The length of the cell brush (6) gradually decreases from both ends of the brush segment (30) toward the middle.

8. The ultrasonic biopsy device according to any one of claims 1 to 7, wherein n brush rings are continuously arranged along the length of the brush segment (30), and the brush rings are composed of several cell brushes (6) arranged around the circumference of the needle core (3).

9. The ultrasonic biopsy device according to any one of claims 1 to 8, wherein... The cell brushes (6) on the brush segment (30) are distributed in a spiral shape.

10. The ultrasonic biopsy instrument according to any one of claims 1 to 9, further comprising: Handle mechanism (1); and Luer seat (4), which is detachably disposed at one end of the handle mechanism (1), The needle tube (2) is connected to and communicates with the Luer seat (4) and / or the handle mechanism, and the other end of the needle tube (2) extends outward from the other end of the handle mechanism (1).

11. The ultrasonic biopsy device according to claim 10, wherein... A connecting cap (5) is fixedly provided at one end of the needle core (3). The connecting cap (5) is sleeved on the outside of the Luer seat (4) and is movablely engaged with the Luer seat (4). The needle core (3) penetrates the inner cavity of the Luer seat (4) and the needle tube (2).

12. The ultrasonic biopsy device according to claim 10 or 11, wherein... The handle mechanism (1) includes a central rod (10), which comprises adjacent first segments (101) and second segments (102). A first sliding sleeve rod (11) is sleeved on the outer side of the first segment (101), and the Luer seat (4) is disposed at one end of the first sliding sleeve rod (11). A first locking member (13) is disposed between the first sliding sleeve rod (11) and the first segment (101). A second sliding sleeve (12) is sleeved on the outer side of the second segment (102), an outer sheath (14) is fixedly provided at the end of the second segment (102), an exit sleeve (15) is fixedly provided at the end of the second sliding sleeve (12), the exit sleeve (15) is sleeved on the outside of the outer sheath (14), the outer sheath (14) is sleeved on the outside of the needle tube (2), and a second locking member (16) is provided between the second sliding sleeve (12) and the second segment (102).

13. The ultrasonic biopsy device according to claim 12, wherein... At least one of the first segment (101), the second segment (102), and the Luer seat (4) is provided with scale markings.

14. The ultrasonic biopsy device according to any one of claims 10 to 13, wherein The Luer seat (4) is snap-fitted to the handle mechanism (1).

15. The ultrasonic biopsy instrument according to any one of claims 10 to 14, further comprising: A protective sleeve (70) has an assembly end block (71) fixedly provided at one end. The assembly end block (71) is restricted within the handle mechanism (1) by the Luer seat (4). The needle tube (2) passes through the assembly end block (71) so that the protective sleeve (70) is fitted onto the outside of the needle tube (2). The assembly end block (71) is provided with a snap-fit ​​cavity (710). An elastic ring (73) is provided at the end of the snap-fit ​​cavity (710) facing away from the Luer seat (4). A boss (31) is fixedly provided on the needle tube (2). The snap-fit ​​cavity (710) is used to accommodate the boss (31). When the boss (31) is located within the snap-fit ​​cavity (710), the elastic ring (73) is used to restrict the boss (31) from moving away from the Luer seat (4). The distance between the boss (31) and the needle tip of the needle tube (2) is less than or equal to the length of the protective sleeve (70).

16. The ultrasonic biopsy device according to any one of claims 1 to 15, wherein A scraping part (33) is provided on the brush section (30) and / or on the needle core (3) near the brush section (30).

17. The ultrasonic biopsy device according to claim 16, wherein... The scraping part (33) is located in the area of ​​the brush section (30) near the end of the needle core (3).

18. The ultrasonic biopsy device according to claim 16, wherein... The scraping part (33) is disposed between the cell brushes (6).

19. The ultrasonic biopsy device according to any one of claims 16 to 18, wherein The scraping part (33) is the rough abrasive surface on the needle core (3).

20. The ultrasonic biopsy device according to any one of claims 16 to 18, wherein The scraping part (33) is composed of a plurality of protruding burrs provided on the needle core (3).

21. The ultrasonic biopsy device according to any one of claims 1 to 20, wherein... The needle core (3) is provided with a spike end (34) at its end.

22. The ultrasonic biopsy device according to any one of claims 1 to 21, wherein The cell brush (6) is made of polymer material.

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