A biopsy device

Abstract

This invention relates to the field of medical device technology and provides a biopsy device. The biopsy device includes a housing assembly, an aspiration assembly, and a rotating assembly. The aspiration assembly includes an aspiration tube movably inserted through the housing assembly. The rotating assembly includes a rotating member connected to the aspiration tube. The rotating member can rotate circumferentially relative to the housing assembly, and the rotating member can drive the aspiration tube to slide axially relative to the housing assembly. This invention employs a rotating needle insertion method. This rotation method allows control of the length of the aspiration tube outside the needle sheath, and it avoids significant wobbling, making needle insertion easier and more stable.

Description

Technical Field

[0001] This invention belongs to the field of medical device technology, and in particular relates to a biopsy device. Background Technology

[0002] A biopsy needle can be used to take samples from lymph nodes or tumors in the lungs. The biopsy needle consists of a needle sheath and a movable aspiration tube inserted into the needle sheath. The aspiration tube needs to be moved along the axis of the needle sheath to reach the puncture site, and tissue fluid is removed in conjunction with an external negative pressure aspiration device.

[0003] When the suction tube is moved to the puncture site, the needle needs to be inserted. The existing needle insertion method is a sliding method, in which the driving component connected to the suction tube slides along the axis of the outer shell assembly, thereby driving the suction tube to insert the needle. The sliding method makes it difficult to control the needle length and causes significant shaking during the insertion process. Summary of the Invention

[0004] The purpose of this invention is to provide a biopsy device that solves the technical problems of existing biopsy needles, such as difficulty in controlling the needle length and significant shaking during insertion.

[0005] The present invention is implemented as follows: a biopsy device includes a housing assembly, an aspiration assembly, and a rotating assembly. The aspiration assembly includes an aspiration tube movably passing through a guide member. The rotating assembly is connected to the aspiration tube. A portion of the rotating assembly is circumferentially rotatable relative to the guide member, and the portion of the rotating assembly that rotates relative to the guide member can drive the aspiration tube to slide axially relative to the guide member.

[0006] The beneficial effects of the present invention are as follows: In the biopsy device of the present invention, some of the rotating components can rotate relative to the guide in the circumferential direction, which can drive the aspiration tube to slide relative to the guide in the axial direction. The needle is inserted by rotation. The length of the aspiration tube outside the needle sheath can be controlled by rotation. Moreover, the rotation method will not produce large shaking, making the needle insertion easier to control and more stable. Attached Figure Description

[0007] Figure 1 This is a schematic diagram of the external structure of the biopsy device in Example 1;

[0008] Figure 2 yes Figure 1 A longitudinal sectional view;

[0009] Figure 3 This is an exploded view of the biopsy device of Example 1;

[0010] Figure 4 This is a schematic diagram of the structure of the housing in the biopsy device of Example 1;

[0011] Figure 5 This is a schematic diagram of the assembly of the sealing component in the biopsy device of Example 1;

[0012] Figure 6 This is a schematic diagram of the external structure of the biopsy device in Example 2;

[0013] Figure 7 yes Figure 6 A longitudinal sectional view;

[0014] Figure 8 This is an exploded view of the biopsy device of Example 2;

[0015] Figure 9 This is a schematic diagram of the threaded sleeve and rotating sleeve in the biopsy device of Example 2;

[0016] Figure 10 This is a schematic diagram of the assembly of the sealing component in the biopsy device of Example 2.

[0017] 100-biopsy device

[0018] 1-Casing assembly,

[0019] 11-Guide component, 111-Guide groove,

[0020] 12- Locking knob

[0021] 13-Shell, 131-Upper shell, 133-Lower shell, 135a-Threaded section, 135b-Threaded section

[0022] 14-End cap,

[0023] 15-Fixed component, 151-Locking block, 153-Connecting rod, 155-Sealing hole, 157-Plug-in component,

[0024] 17-Axial fixing sleeve,

[0025] 3-Suction Component

[0026] 31-Suction tube, 33-Needle sheath, 35-Needle core,

[0027] 5-Rotating assembly

[0028] 51-Slider,

[0029] 53-Rotating component, 531-Threaded sleeve, 5311-Connecting component, 533-Rotating sleeve, 5331-Slot, 535-Anti-slip protrusion.

[0030] 57-Plunger rod, 571-Scale section

[0031] 7-Sealing components

[0032] 71-Sealed pipe, 71a-Stainless steel pipe, 71b-Hose,

[0033] 73-Seal, 73a-Sealing knob, 731a-Connector, 733a-Sealing part, 73b-Adhesive layer. Detailed Implementation

[0034] To make the objectives, technical solutions, and advantages of this invention clearer, the invention will be further described in detail below with reference to the accompanying drawings and embodiments. It should be understood that the specific embodiments described herein are merely illustrative and not intended to limit the invention.

[0035] It should be noted that when a component is referred to as "fixed to" or "set on" another component, it can be directly on the other component or may have an intervening component present. When a component is referred to as "connected to" another component, it can be directly connected to the other component or may have an intervening component present.

[0036] It should also be noted that the directional terms such as left, right, up, and down in this embodiment are only relative concepts or are based on the normal use of the product, and should not be considered as restrictive.

[0037] It should be noted that in the field of interventional medical devices, the end of a medical device implanted in the human or animal body that is closer to the operator is generally called the "proximal end," and the end that is farther from the operator is called the "distal end." Based on this principle, the "proximal end" and "distal end" of any component of a medical device are defined. "Axial direction" generally refers to the length direction of the medical device during delivery, and "radial direction" generally refers to the direction of the medical device perpendicular to its "axial direction." Based on this principle, the "axial direction" and "radial direction" of any component of a medical device are defined.

[0038] Example 1

[0039] As attached Figure 1 As shown, this embodiment 1 provides a biopsy device 100, which includes a housing assembly 1, an aspiration assembly 3, and a rotation assembly 5. The biopsy device 100 can sample lymph nodes or tumors in the lungs of a human body.

[0040] As attached Figure 2 As shown, the outer casing assembly 1 includes a guide 11, a housing 13, a fixing member 15, a locking knob 12, and an end cap 14. The fixing member 15 is disposed inside the housing 13. The housing 13, the locking knob 12, and the end cap 14 are assembled together to form an outer casing assembly 1 structure. The locking knob 12 and the end cap 14 have through holes along the axial direction to facilitate the passage of the suction tube 31.

[0041] As attached Figure 3 , 4As shown, the housing 13 has a cavity that can accommodate part of the suction assembly 3 and part of the rotating assembly 5. For ease of installation, the housing 13 in this embodiment is a split structure, including an upper shell 131 and a lower shell 133 connected to the upper shell 131. In this embodiment, the upper shell 131 and the lower shell 133 together form the cavity. The upper shell 131 and the lower shell 133 can be fixed together by various methods such as snap-fit, bonding, and high-temperature melt adhesive. In this embodiment, the housing 13 is fixedly connected to the locking knob 12 by threads. Specifically, the distal end of the housing 13 has an outwardly extending threaded section 135a, and the threaded section 135a has external threads. In this embodiment, the housing 13 is fixedly connected to the end cap 14 by threads. Specifically, the proximal end of the housing 13 has an outwardly extending threaded section 135b, and the threaded section 135b has external threads.

[0042] As attached Figure 2 , 3 As shown, guide member 11 is disposed on housing 13. When the partial suction assembly 3 and the partial rotating assembly 5 slide within the receiving cavity, guide member 11 guides the movement direction of the partial suction assembly 3 and the partial rotating assembly 5, causing them to move along the axial direction of guide member 11. In this embodiment, guide member 11 includes guide groove 111. Guide groove 111 extends along an axial direction parallel to housing 13. Guide groove 111 radially penetrates the inner and outer surfaces of housing 13. Guide groove 111 communicates with the receiving cavity of housing 13. The total length of guide groove 111 is approximately one-third to one-half of the entire housing 13. At least one of upper shell 131 and lower shell 133 is provided with guide groove 111. Guide groove 111 is used to guide sliding member 51 to slide along the axis. In this embodiment, guide groove 111 is a split structure. Guide groove 111 includes an upper sliding groove disposed on upper shell 131 and a lower sliding groove disposed on lower shell 133. When the upper shell 131 and the lower shell 133 are enclosed together, the upper sliding groove and the lower sliding groove of the guide groove 111 are combined to form a complete guide groove 111.

[0043] As attached Figure 3 , 4 As shown, the locking knob 12 in this embodiment has an internal threaded hole. The internal threaded hole of the locking knob 12 engages with the external thread of the threaded section 135a. The locking knob 12 is fixed to the distal end of the housing 13, closing the distal end of the housing 13. Of course, in other embodiments, the housing 13 and the locking knob 12 can also be connected by other detachable methods, such as plug-in or snap-fit.

[0044] As attached Figure 3 , 4As shown, the end cap 14 in this embodiment is provided with an internal threaded hole. The internal threaded hole of the end cap 14 engages with the external thread of the threaded segment 135b. The end cap 14 is fixed to the proximal end of the housing 13, closing the proximal end of the housing 13. Of course, in other embodiments, the housing 13 and the end cap 14 can also be connected by other detachable methods, such as plug-in or snap-fit.

[0045] As attached Figure 2 , 3 As shown, in this embodiment, the fixing member 15 is disposed within the receiving cavity of the housing 13. The fixing member 15 is fixed to the upper housing 131 or the lower housing 133, and is located between the upper housing 131 and the lower housing 133. The fixing member 15 is used to fix the suction tube 31. (See attached diagram) Figure 5 As shown, the fixing member 15 in this embodiment includes a pair of symmetrically arranged locking blocks 151 and a connecting rod 153 connecting the pair of locking blocks 151. The fixing member 15 has a through hole along the axial direction to facilitate the passage of the suction tube 31. The fixing member 15 is located at the distal end of the housing 13. The housing 13 has a locking position (not shown in the figure) that matches the structure of the locking blocks 151, and the locking blocks 151 are fixedly connected to the housing 13. The fixing member 15 can increase the stability of the suction tube 31.

[0046] As attached Figure 2 , 3 As shown, the suction assembly 3 of this embodiment includes a suction tube 31 movably inserted through the outer shell assembly 1, a needle sheath 33 sleeved outside the suction tube 31, and a needle core 35 inserted through the suction tube 31 and the needle sheath 33. At least a portion of the needle sheath 33 is located outside the shell 13 and connected to the distal end of the shell 13. The proximal end of the needle sheath 33 is located at the distal end of the shell 13 and is connected to the fixing member 15. At least a portion of the needle sheath 33 is located outside the fixing member 15. In this embodiment, the needle sheath 33 is inserted into the through hole of the locking block 151 and is fixedly connected to the locking block 151. The suction tube 31 is movably inserted through the shell 13 and the needle sheath 33 and can move within the receiving cavity along the axial direction of the shell 13 and the needle sheath 33. The proximal end of the suction tube 31 is close to the proximal end of the shell 13, and the distal end of the suction tube 31 is close to the distal end of the needle sheath 33. The distal end of the suction tube 31 passes through the fixation member 15 and is located at the distal end of the needle sheath 33. After sliding, the distal end of the suction tube 31 can protrude outside the distal end of the needle sheath 33. With the assistance of the endoscopic ultrasound, the suction tube 31 moves along the axial direction of the shell 13 with the help of external force, so that the distal end of the suction tube 31 reaches the lesion area.

[0047] As attached Figure 2 , 3 As shown, the rotating assembly 5 in this embodiment includes a slider 51 at least partially disposed within the housing 13, a rotating member 53 connected to the slider 51, and a plunger rod 57 connected to the slider 51.

[0048] As attached Figure 2As shown, in this embodiment, the rotating component 53 is connected to the suction tube 31 to drive the suction tube 31 to slide relative to the outer shell assembly 1. Under the action of external force, the rotating component 53 can rotate circumferentially along the outer shell assembly 1. The rotating component 53 can drive the suction tube 31 to slide axially relative to the outer shell assembly 1. The needle extension length of the suction tube 31 is controlled by the rotating component 53 rotating relative to the outer shell assembly 1. By controlling the needle extension length of the suction tube 31 by rotating the rotating component 53, the accuracy of the needle extension length can be improved to the mm level, reducing the harm to the patient caused by factors such as doctor's misoperation. Moreover, the rotation method does not produce large shaking, making the needle insertion process more stable and smooth, and improving the safety of the operation.

[0049] As attached Figure 2 , 3 As shown, in this embodiment, the rotating component 53 is fitted onto the proximal end of the housing 13 for easy operation by the doctor. The rotating component 53 in this embodiment includes a threaded sleeve 531 fitted onto the housing 13. The inner wall of the threaded sleeve 531 has internal threads. For ease of installation, the threaded sleeve 531 in this embodiment is a split structure, including an upper threaded sleeve and a lower threaded sleeve connected to the upper threaded sleeve. The upper and lower threaded sleeves are joined to form a complete threaded sleeve 531. The upper and lower threaded sleeves can be fixed together using various methods such as snap-fit ​​or adhesive bonding. To facilitate the doctor's rotation of the rotating component 53, the outer wall of the rotating component 53 in this embodiment has multiple spaced anti-slip protrusions 535. The anti-slip protrusions 535 in this embodiment are located on the threaded sleeve 531. These anti-slip protrusions 535 increase the friction between the doctor's hand and the rotating component 53, facilitating the doctor's rotation of the rotating component 53. Because the threaded sleeve 531 is fitted outside the housing 13, in order to maintain the flatness of the outer surface of the biopsy device 100, the portion of the housing 13 corresponding to the threaded sleeve 531 is radially recessed. After the threaded sleeve 531 is installed, the outer wall of the threaded sleeve 531 is flush with the outer wall of the housing 13.

[0050] As attached Figure 2 , 3As shown, in this embodiment, the sliding member 51 is connected to the suction tube 31. Specifically, the sliding member 51 has a through hole along the axial direction, which facilitates the needle core 35 and part of the suction tube 31 to pass through. The proximal end of the suction tube 31 is fixedly connected to the sliding member 51. When the rotating member 53 rotates circumferentially relative to the outer shell assembly 1, the sliding member 51 can drive the suction tube 31 to slide. In this embodiment, the sliding member 51 is generally square in structure, and the outer edge of the sliding member 51 has an external thread that is threaded to the threaded sleeve 531. The sliding member 51 is located inside the housing 13. The sliding member 51 cooperates with the guide member 11 on the outer shell assembly 1, and the guide member 11 is used to guide the sliding member 51 to slide along the axis. The guide groove 111 passes through the housing 13, which allows the sliding member 51, which is disposed in the housing 13, to be partially exposed from the guide groove 111. The exposed part of the sliding member 51 is threadedly connected to the threaded sleeve 531 through the guide groove 111, and the rotation of the threaded sleeve 531 drives the sliding member 51 to slide along the axial direction of the outer shell assembly 1. Specifically, the external thread of the slider 51 protrudes from the guide groove 111, and the threaded sleeve 531 is connected to the external thread of the slider 51 through the internal thread, which drives the slider 51 to slide along the guide groove 111.

[0051] As attached Figure 2 , 3 As shown, the plunger rod 57 in this embodiment has a rod-shaped structure and a through hole along the axial direction to facilitate the passage of the needle core 35. To facilitate the monitoring of the movement distance of the suction tube 31, a scale segment 571 is provided on the plunger rod 57 along the axial direction, and multiple scale lines are pre-engraved on the scale segment 571. The multiple scale lines are marked at equal intervals of 0.2cm, 0.5cm, or 1cm. The distal end of the plunger rod 57 passes through the end cap 14 and connects to the slider 51. When the slider 51 slides, it drives the plunger rod 57 to move axially together, and part of the scale segment 571 is housed within the housing 13. By observing the changes in the exposed scale segment 571 of the plunger rod 57, the distance moved by the slider 51 can be determined, and the needle insertion status of the suction tube 31 can be monitored. The slider 51 and the plunger rod 57 can be connected and fixed in various ways. For example, in this embodiment, the slider 51 and the plunger rod 57 are an integral structure, which is convenient for overall installation. The scale value of the scale segment 571 increases from zero from the far end to the near end, making the movement distance of the slider 51 more intuitive.

[0052] As attached Figure 3 , 5As shown, to ensure better airtightness than competing products, the biopsy device 100 of this embodiment further includes a sealing assembly 7. The sealing assembly 7 includes a sealing tube 71 and a sealing element 73. The sealing tube 71 is sleeved outside the aspiration tube 31 and located inside the housing 13. The sealing tube 71 is disposed between the sliding member 51 and the fixing member 15. In this embodiment, the sealing tube 71 is a stainless steel tube 71a, with its proximal end inserted into the sliding member 51 and fixedly connected to it. The sealing element 73 is located between the sealing tube 71 and the fixing member 15. The distal end of the sealing tube 71 is inserted into the axial through hole of the fixing member 15 and is axially movable relative to the fixing member 15. In this embodiment, the sealing element 73 includes a sealing knob 73a. The fixing member 15 has a sealing hole 155, and at least a portion of the sealing knob 73a is located within the sealing hole 155. Specifically, the sealing knob 73a includes a connecting portion 731a and a sealing portion 733a connected to the connecting portion 731a. The sealing portion 733a has external threads. The locking block 151 of the fixing member 15 near the stainless steel tube 71a has a sealing hole 155. The sealing hole 155 has internal threads that mate with the sealing portion 733a. The sealing portion 733a is threadedly connected to the locking block 151. The outer diameter of the connecting portion 731a is larger than the inner diameter of the sealing hole 155. The sealing portion 733a is located within the sealing hole 155, and the connecting portion 731a limits the installation depth of the sealing knob 73a within the sealing hole 155. The stainless steel tube 71a extends axially through the sealing knob 73a.

[0053] The biopsy device 100 of this embodiment also includes a negative pressure aspiration device (not shown) connected to the aspiration tube 31. The negative pressure aspiration device is used to aspirate liquid from the aspiration tube 31. A plunger rod 57 is used to connect to the negative pressure aspiration device, which can be a negative pressure injector. The head of the negative pressure injector and the plunger rod 57 can be connected and fixed in various ways. In this embodiment, the head of the negative pressure injector and the plunger rod 57 are connected by a thread, which allows for quick connection of the negative pressure injector. When a negative pressure injector is connected to the tail of the biopsy device 100, the good airtightness can improve the aspiration efficiency of the biopsy device 100, reduce the operation time, reduce the surgical risk, and reduce the pain caused by prolonged surgery for the patient.

[0054] In the biopsy device 100 of Embodiment 1 of the present invention, the specific adjustment method is as follows: In the initial state, the inner wall of the threaded sleeve 531 is in contact with the outer edge of the sliding member 51 exposed outside the guide groove 111. Rotating the threaded sleeve 531 causes the internal thread of the threaded sleeve 531 to engage with the external thread of the sliding member 51. Under the guidance of the guide groove 111, the sliding member 51 moves axially within the guide groove 111. During the sliding process, the sliding member 51 drives the suction tube 31, which is fixedly connected to the sliding member 51, to slide axially. Simultaneously, during the sliding process, the sliding member 51 drives the plunger rod 57 to move together. By observing the change in the scale segment 571 exposed on the plunger rod 57, the distance moved by the sliding member 51 can be determined, thus controlling the insertion of the suction tube 31. When the suction tube 31 reaches the appropriate position, the rotation of the threaded sleeve 531 is stopped. The threaded connection between the threaded sleeve 531 and the sliding member 51 self-locks the sliding member 51, keeping the suction tube 31 stationary. Because the aspiration tube 31 of the biopsy device 100 has a very small diameter and the density of human tissue is uneven, the spiral drive makes needle insertion smoother and more stable, greatly reducing medical accidents caused by the bending and breakage of the aspiration tube 31, and improving surgical safety. Furthermore, the insertion force and speed of traditional biopsy needles rely on the surgeon's experience, which has a high learning curve. This embodiment controls the needle exit length through a threaded drive, reducing the demands on the operator. It also improves the accuracy of the needle exit length to the millimeter level, reducing harm to the patient caused by factors such as surgeon error.

[0055] The specific adjustment steps are as follows: Step 1: Insert the endoscopic ultrasound into the patient's body and determine the location of the lymph nodes or mass based on chest imaging data, ensuring the endoscopic ultrasound reaches the target area; Step 2: Fill the balloon with an appropriate amount of water, turn on ultrasound to observe the size of the lymph nodes, and turn on Doppler to understand the internal blood supply and its relationship with surrounding blood vessels; Step 3: Adjust the endoscopic ultrasound to the appropriate puncture position, measure and determine the puncture depth, and ensure that the threaded sleeve 531 of the biopsy device 100 is rotated to the highest position; Step 4: Insert the biopsy device 100 into the operating channel of the endoscopic ultrasound, keeping the front end of the endoscopic ultrasound at the same position during insertion. In a straight position, advance the needle until the head of the aspiration tube 31 of the biopsy device 100 is slightly visible under the ultrasound endoscope. Adjust the angle of the ultrasound endoscope again to obtain the ideal puncture position. Step 5: Observe the ultrasound image while rotating the threaded sleeve 531 to insert the needle, confirming that the biopsy device 100 is in the lesion. Gently push the needle core 35 of the biopsy device 100 downwards several times to clear the cavity in the aspiration tube 31. Pull out the needle core 35 and connect it to the negative pressure injector. Step 6: Open the negative pressure injector to aspirate, then close the negative pressure injector and pull the puncture needle out of the patient's body. Remove the negative pressure injector and the biopsy device 100 to obtain the sample. Because the needle core 35 is present in the aspiration tube 31 before aspiration, it can prevent tissue from entering the aspiration tube 31 during the puncture process, thus avoiding the aspiration tube 31 being blocked by tissue before the tissue fluid can be extracted, thereby improving the biopsy success rate.

[0056] Example 2

[0057] As attached Figure 6 As shown, a biopsy device 100 provided in Embodiment 2 includes a housing assembly 1, an aspiration assembly 3, and a rotation assembly 5. Embodiment 2 is similar in principle to Embodiment 1, but there are some differences in the specific structures of the housing assembly 1, the aspiration assembly 3, and the rotation assembly 5.

[0058] As attached Figure 7 , 8 As shown, the outer casing assembly 1 of this embodiment includes a guide 11, a housing 13, a fixing member 15, a locking knob 12, an end cap 14, and an axial fixing sleeve 17.

[0059] An axial fixing sleeve 17 is disposed within the housing 13. The axial fixing sleeve 17 is located within the receiving cavity of the housing 13 and is arranged along the axial direction of the housing 13. The axial fixing sleeve 17 is fixed to the upper housing 131 or the lower housing 133, and is located between the upper housing 131 and the lower housing 133. The axial fixing sleeve 17 includes a cavity that extends axially. A portion of the suction assembly 3 and a portion of the rotating assembly 5 can slide relative to the axial fixing sleeve 17 within the cavity of the axial fixing sleeve 17. To facilitate the installation of the suction assembly 3 and the portion of the rotating assembly 5 within the axial fixing sleeve 17, the axial fixing sleeve 17 in this embodiment can adopt a split structure, including an upper axial fixing sleeve and a lower axial fixing sleeve connected to the upper axial fixing sleeve. In this embodiment, the upper axial fixing sleeve and the lower axial fixing sleeve together form a receiving cavity. The upper axial fixing sleeve and the lower axial fixing sleeve can be fixed together by various methods such as snap-fitting, bonding, or high-temperature melt adhesive. In this embodiment, the axial fixing sleeve 17 is fixedly connected to the end cap 14 by threads. Specifically, the near end of the axial fixing sleeve 17 is provided with an outwardly extending threaded section 135b, and the threaded section 135b is provided with external threads.

[0060] The guide member 11 is disposed within the housing 13. The guide member 11 includes a guide groove 111. The guide groove 111 radially penetrates the inner and outer surfaces of the axial fixing sleeve 17. The guide groove 111 communicates with the cavity of the axial fixing sleeve 17. The total length of the guide groove 111 is approximately one-third to one-half of the entire axial fixing sleeve 17.

[0061] As attached Figure 7 , 8 As shown, in this embodiment, the housing 13 and the locking knob 12 are fixedly connected by threads. Specifically, the distal end of the housing 13 has an outwardly extending threaded section 135a, which has external threads. Correspondingly, the locking knob 12 in this embodiment has an internal threaded hole. The internal threaded hole of the locking knob 12 engages with the external thread of the threaded section 135a. The locking knob 12 is fixed to the distal end of the housing 13, closing the distal end of the housing 13. Of course, in other embodiments, the housing 13 and the locking knob 12 can also be connected by other detachable methods, such as plug-in or snap-fit.

[0062] As attached Figure 7 , 8 As shown, the end cap 14 in this embodiment is provided with an internal threaded hole. The internal threaded hole of the end cap 14 engages with the external thread of the threaded segment 135b. The end cap 14 is fixed to the proximal end of the axial fixing sleeve 17, thus closing the proximal end of the axial fixing sleeve 17. Of course, in other embodiments, the axial fixing sleeve 17 and the end cap 14 can also be connected by other detachable methods, such as plug-in or snap-fit.

[0063] As attached Figure 7 , 8As shown, in this embodiment, the fixing member 15 is located inside the housing 13. The fixing member 15 is fixedly attached to the upper housing 131 and / or the lower housing 133, and is located between the upper housing 131 and the lower housing 133. In this embodiment, the fixing member 15 has an overall rectangular structure. The fixing member 15 is located at the far end of the housing 13. The housing 13 has a locking slot (not shown in the figure) that matches the structure of the fixing member 15, and the fixing member 15 is fixedly connected to the housing 13. The fixing member 15 can increase the stability of the suction tube 31.

[0064] As attached Figure 8 , 9 As shown, the rotating component 53 in this embodiment includes a threaded sleeve 531 and a rotating sleeve 533.

[0065] The inner wall of the threaded sleeve 531 in this embodiment has an internal thread along the axial direction. The threaded sleeve 531 is fitted over the axial fixing sleeve 17. Specifically, the threaded sleeve 531 is fitted between the housing 13 and the axial fixing sleeve 17. The axial length of the threaded sleeve 531 corresponds to the axial length of the axial fixing sleeve 17. The internal thread of the threaded sleeve 531 corresponds to the guide groove 111 provided on the axial fixing sleeve 17. At least part of the sliding member 51 is located outside the guide groove 111 and is threadedly connected to the threaded sleeve 531. The rotation of the threaded sleeve 531 causes the sliding member 51 to slide. To facilitate the installation of the sliding member 51, the threaded sleeve 531 in this embodiment has a split structure, including an upper threaded sleeve and a lower threaded sleeve connected to the upper threaded sleeve. The upper threaded sleeve and the lower threaded sleeve are closed to form a complete threaded sleeve 531. The upper threaded sleeve and the lower threaded sleeve can be fixed by various methods such as snap-fit, bonding, and high-temperature melt adhesive. A connecting member 5311 is provided on the threaded sleeve 531. The threaded sleeve 531 is fixedly connected to the rotating sleeve 533 via a connector 5311. In this embodiment, the connector 5311 is axially disposed on the outer wall of the threaded sleeve 531 and the rotating sleeve 533 that mate. In this embodiment, multiple connectors 5311 are arranged around the axis of the threaded sleeve 531.

[0066] In this embodiment, the rotating sleeve 533 is fitted over the threaded sleeve 531. The axial length of the rotating sleeve 533 is less than the axial length of the threaded sleeve 531, and the rotating sleeve 533 partially fits over the threaded sleeve 531. The rotating sleeve 533 and the threaded sleeve 531 are fixedly connected together. The rotation of the rotating sleeve 533 causes the threaded sleeve 531 to rotate. The rotating threaded sleeve 531 causes the sliding member 51 to slide axially along the guide groove 111. The sliding member 51 then drives the suction tube 31 to move. (See attached...) Figure 9As shown, the rotating sleeve 533 of this embodiment is provided with a groove 5331 that matches the connector 5311. The end of the connector 5311 is located in the groove 5331. The connector 5311 of the threaded sleeve 531 engages with the groove 5331 of the rotating sleeve 533. The rotation of the rotating sleeve 533 drives the threaded sleeve 531 to rotate. To facilitate the doctor's rotation of the rotating component 53, the outer wall of the rotating component 53 of this embodiment is provided with a plurality of spaced anti-slip protrusions 535. The anti-slip protrusions 535 of this embodiment are provided on the rotating sleeve 533. These anti-slip protrusions 535 can increase the friction between the doctor's hand and the rotating component 53, making it easier for the doctor to rotate the rotating component 53.

[0067] As attached Figure 7 , 8 As shown, a threaded sleeve 531 and a rotating sleeve 533 are sequentially fitted around the axial fixing sleeve 17. To maintain the flatness of the biopsy device 100's outer surface, the portions of the axial fixing sleeve 17 corresponding to the threaded sleeve 531 and the rotating sleeve 533 are radially recessed. After the rotating sleeve 533 is installed, its outer edge is flush with the outer edge of the housing 13. The housing 13, locking knob 12, end cap 14, and rotating sleeve 533 are assembled together to form a closed biopsy device 100 structure.

[0068] As attached Figure 8 , 10 As shown, the slider 51 in this embodiment has a square structure. The outer edge of the slider 51 has an external thread that connects to the threaded sleeve 531. The slider 51 is located inside the axial fixing sleeve 17. The external thread on the slider 51 can protrude from the guide groove 111 provided on the axial fixing sleeve 17. Part of the slider 51 is threadedly connected to the threaded sleeve 531 via the guide groove 111. The slider 51 has a through hole along the axial direction, facilitating the passage of the needle core 35 and part of the suction tube 31. The proximal end of the suction tube 31 is fixedly connected to the slider 51, and the slider 51 can drive the suction tube 31 to move together. In this embodiment, the slider 51 and the plunger rod 57 are respectively provided with mutually mating threaded connection structures, and the slider 51 and the plunger rod 57 are connected by threads.

[0069] As attached Figure 10As shown, the biopsy device 100 of this embodiment also includes a sealing assembly 7. The sealing assembly 7 of this embodiment includes a sealing tube 71b and a sealing element 73b. Specifically, the sealing tube 71b is an axially expandable elastic tube. The sealing tube 71b is sleeved outside the aspiration tube 31 and located inside the housing 13, positioned between the sliding member 51 and the fixing member 15. The proximal end of the sealing tube 71b is fixedly connected to the sliding member 51. The distal end of the sealing tube 71b is sealed to the fixing member 15 via the sealing element 73b. In this embodiment, the sealing element 73 is an adhesive layer. Both the fixing member 15 and the sliding member 51 are provided with insertion members 157. The insertion member 157 has a rod-shaped structure. The insertion member 157 is located at the proximal end of the fixing member 15. Another insertion member 517 is located at the distal end of the sliding member 51. Both ends of the sealing tube 71b are respectively sleeved outside the two insertion members 157. The seal 73b is located between the sealing tube 71b and the connector 151b. The sealing tube 71b and the connector 157 are bonded and fixed together. When the biopsy device 100 is in... Figure 7 In the state shown (hereinafter referred to as the initial state), the sliding member 51 is at the closest end of its travel stroke, and the sealing tube 71b is in a stretched state. As the sliding member 51 moves further away from the housing 13, the sealing tube 71b gradually shortens. That is to say, the axial length of the sealing tube 71b in the initial state is greater than that in the natural state (e.g., ...). Figure 10 As shown, the axial length of the sealing tube 71b is such that it is not subjected to axial pressure or axial tension at both ends. This configuration not only provides tension towards the distal end but also provides suitable space for the movement of the sliding member 51, preventing obstruction of the sliding member 51's movement relative to the housing 13 during its travel. In this embodiment, the sealing tube 71b is a PU polyurethane flexible tube, which has an axial compression limit, meaning it cannot be compressed further after reaching a certain axial compression limit. Therefore, the sealing tube 71b also prevents the sliding member 51 from moving excessively distally, reducing the risk of tissue puncture and improving surgical safety. It is understood that in other embodiments, the connector 157 may be omitted, as long as both ends of the sealing tube 71b can be sealed and fixed to the sliding member 51 and the fixing member 15, respectively. In other embodiments, the sealing tube 71b can also be an axially expandable elastic tube such as a medical silicone flexible tube or a polytetrafluoroethylene flexible tube.

[0070] In the biopsy device 100 of Embodiment 2 of the present invention, the specific adjustment method is as follows: In the initial state, the inner wall of the threaded sleeve 531 is in contact with the outer edge of the sliding member 51 exposed outside the guide groove 111. Rotating the rotating sleeve 533 causes the threaded sleeve 531 to rotate together, and the internal thread of the threaded sleeve 531 engages with the external thread of the sliding member 51. Under the guidance of the guide groove 111, the sliding member 51 moves axially within the guide groove 111. During the movement, the sliding member 51 drives the suction tube 31, which is fixedly connected to the sliding member 51, to slide axially. Simultaneously, during the movement, the sliding member 51 drives the plunger rod 57 to move together. By observing the change in the exposed scale segment 571 of the plunger rod 57, the distance moved by the sliding member 51 can be determined, thus controlling the insertion of the suction tube 31. When the aspiration tube 31 reaches the appropriate position, the rotating sleeve 533 stops rotating. The threaded connection between the threaded sleeve 531 and the sliding member 51 self-locks the sliding member 51, keeping the aspiration tube 31 stationary. Because the diameter of the aspiration tube 31 in the biopsy device 100 is very small, and human tissue density is uneven, the helical drive makes needle insertion smoother and more stable, greatly reducing medical accidents caused by the bending and breakage of the aspiration tube 31, and improving surgical safety. Furthermore, the insertion force and speed of traditional biopsy needles rely on the surgeon's experience, resulting in a high learning curve. This embodiment controls the needle extension length through a threaded drive, reducing the demands on the operator. It also improves the accuracy of the needle extension length to the millimeter level, reducing harm to the patient caused by factors such as doctor error.

[0071] The specific adjustment steps are as follows: Step 1: Insert the endoscopic ultrasound into the patient's body and determine the location of the lymph nodes or mass based on chest imaging data, ensuring the endoscopic ultrasound reaches the target area; Step 2: Fill the balloon with an appropriate amount of water, turn on ultrasound to observe the size of the lymph nodes, and turn on Doppler to understand the internal blood supply and its relationship with surrounding blood vessels; Step 3: Adjust the endoscopic ultrasound to the appropriate puncture position, measure and determine the puncture depth, and ensure that the rotating sleeve 533 of the biopsy device 100 is rotated to the highest position; Step 4: Insert the biopsy device 100 into the operating channel of the endoscopic ultrasound, keeping the front end of the endoscopic ultrasound at the same position during insertion. In a straight position, advance the needle until the head of the aspiration tube 31 of the biopsy device 100 can be slightly seen under the ultrasound endoscope. Adjust the angle of the ultrasound endoscope again to obtain the ideal puncture position. Step 5: Observe the ultrasound image while rotating the threaded sleeve 531 to insert the needle, confirm that the biopsy device 100 is in the lesion. Gently push the needle core 35 of the biopsy device 100 downwards several times to clean the cavity in the aspiration tube 31. Pull out the needle core 35 and connect it to the negative pressure injector. Step 6: Open the negative pressure injector to aspirate, then close the negative pressure injector and pull the puncture needle out of the patient's body. Remove the negative pressure injector and the biopsy device 100 to obtain the sample.

[0072] The above description is only a preferred embodiment of the present invention and is not intended to limit the present invention. Any modifications, equivalent substitutions or improvements made within the spirit and principles of the present invention should be included within the protection scope of the present invention.

Claims

1. A biopsy device, characterized in that, The device includes a housing assembly, a suction assembly, and a rotating assembly. The suction assembly includes a suction tube that is movably inserted through the housing assembly. The rotating assembly includes a rotating member connected to the suction tube. The rotating member is circumferentially rotatable relative to the housing assembly, and the rotating member can drive the suction tube to slide axially relative to the housing assembly. The rotating assembly includes a sliding member connected to the rotating member. The sliding member is connected to the suction tube. When the rotating member rotates circumferentially relative to the outer shell assembly, the sliding member can drive the suction tube to slide. The outer shell assembly includes a shell and a fixing member disposed within the shell. The shell includes an upper shell and a lower shell connected to the upper shell. The fixing member is fixed to the upper shell or the lower shell. The suction assembly also includes a needle sleeve sleeved over the suction tube. The needle sleeve is connected to the fixing member. At least a portion of the needle sleeve is located outside the shell. The distal end of the suction tube passes through the fixing member and is located at the distal end of the needle sleeve. The distal end of the suction tube, after sliding, can protrude beyond the distal end of the needle sleeve. The biopsy device further includes a sealing assembly, which includes a sealing tube that is sleeved outside the aspiration tube and located inside the housing. The sealing tube is disposed between the sliding member and the fixing member.

2. The biopsy device as described in claim 1, characterized in that, The housing assembly includes a guide and a housing. The guide is used to guide the sliding member to slide along an axis. The guide is disposed on or inside the housing.

3. The biopsy device as described in claim 2, characterized in that, The guide member is disposed on the housing, and the guide member includes a guide groove that radially penetrates the inner and outer surfaces of the housing.

4. The biopsy device as described in claim 3, characterized in that, The rotating component includes a threaded sleeve fitted outside the housing, the sliding component is located inside the housing, and part of the sliding component is threadedly connected to the threaded sleeve via the guide groove. The rotation of the threaded sleeve drives the sliding component to slide.

5. The biopsy device as described in claim 2, characterized in that, The guide member is disposed within the housing, and the housing assembly further includes an axial fixing sleeve disposed within the housing. The guide member includes a guide groove that radially penetrates the inner and outer surfaces of the axial fixing sleeve.

6. The biopsy device as described in claim 5, characterized in that: The rotating component includes a threaded sleeve and a rotating sleeve. The threaded sleeve is fitted outside the axial fixed sleeve, and the sliding component is located inside the axial fixed sleeve. Part of the sliding component is threadedly connected to the threaded sleeve via the guide groove. The rotating sleeve is fixedly connected to the threaded sleeve. The rotation of the rotating sleeve drives the threaded sleeve to rotate, and the rotating threaded sleeve drives the sliding component to slide.

7. The biopsy device as described in claim 6, characterized in that: The threaded sleeve is provided with a connector, and the rotating sleeve is provided with a groove that matches the connector. The end of the connector is located in the groove, and the rotation of the rotating sleeve drives the threaded sleeve to rotate.

8. The biopsy device as claimed in claim 1, characterized in that, The sealing assembly further includes a seal located between the sealing tube and the fixing member.

9. The biopsy device as claimed in claim 1, characterized in that, The sealing tube includes an axially expandable elastic tube, with the sliding member and the fixing member respectively connected to its two ends. When the sliding member is located at the proximal end of its travel stroke, the sealing tube is in a stretched state.

10. The biopsy device as claimed in claim 1, characterized in that, The rotating assembly also includes a plunger rod connected to the sliding member. The plunger rod has a scale segment along the axial direction. When the sliding member slides, part of the scale segment is housed within the housing.

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