A deep layer biopsy instrument for digestive endoscope

Abstract

The application provides a kind of digestive endoscope deep biopsy instrument, including deep cutting component, fixed component and push cutting assembly, the deep cutting component, fixed component and push cutting assembly are all pure mechanical drive structure by manual force transmission power, without external electric energy and electric energy transmission wire, rely on mechanical transmission to realize operation all the way, without any electric drive element and electric energy participation, the application is through the recess and protruding sliding fit structure of deep cutting component and fixed component, combined with the transmission design of push cutting assembly, with the ring blade edge of the front end of deep cutting component and 30°-60° inclination angle, to realize the stable push cutting of deep tissue with the principle of overtube knife, then complete accurate disconnection through the sawtooth disconnection blade integrated in push cutting assembly, solve the problem that traditional instrument is difficult to go deep, low cutting efficiency, significantly improve the integrity and sampling accuracy of deep tissue sample.

Description

Technical Field

[0001] This invention relates to the field of medical device technology, and more specifically, to a deep biopsy device for digestive endoscopy. Background Technology

[0002] Endoscopic biopsy is an important method for obtaining tissue samples for the pathological diagnosis of gastrointestinal diseases. Clinically, the commonly used sampling instruments are primarily biopsy forceps that enter the digestive tract through the working channel of the endoscope. A typical structure includes a handle and slider (or push-pull mechanism), an outer sheath, an operating wire (traction wire), and a distal forceps cup. The forceps cup is opened and closed by pushing or pulling the operating wire at the handle end to excise mucosal tissue specimens. This type of instrument has a mature structure, is easy to use, and is suitable for routine sampling of most superficial mucosal lesions.

[0003] However, with the increasing discovery of subepithelial lesions (SELs) and deep invasive lesions in the digestive tract, the clinical demand for deep histological specimens is constantly increasing. Since SELs are mostly located below the epithelial layer and often originate from the submucosa or muscularis propria, tissue acquisition is inherently challenging. Existing conventional biopsy forceps often struggle to penetrate the mucosa and reliably reach deeper layers, frequently obtaining only mucosal tissue, leading to insufficient sampling or non-diagnostic results; relevant clinical consensus also indicates that mucosal biopsies of SELs using standard biopsy forceps are often non-diagnostic. In systematic reviews and meta-analyses, the overall diagnostic rate of conventional endoscopic biopsy methods for these lesions was relatively low (around 40% in the overall diagnostic rate), suggesting an inherent limitation in its ability to obtain samples from deep lesions. To improve the sampling rate of deep lesions, clinical trials have attempted to use methods such as "large jaw / giant forceps," tunnel biopsy with repeated biting sampling, and decapping / uncapping sampling, aiming to expose or access the lesion surface. However, this type of method often requires repeated cutting at the same point, the operation depends on experience, and bleeding can affect the field of vision and reduce efficiency; at the same time, in comparative studies, tunnel biopsy still performs worse than other deep sampling techniques.

[0004] Currently, the main alternative approaches for obtaining histological specimens from deep lesions include endoscopic ultrasound-guided fine-needle aspiration / biopsy (EUS-FNA / FNB) and mucosal incision-assisted biopsy (MIAB). Related analyses show that the pooled diagnostic rate of EUS-FNA and EUS-FNB is significantly higher than that of conventional endoscopic biopsy, while MIAB can further improve the histological diagnostic rate in some studies. However, these methods typically require more sophisticated equipment and operational skills, and MIAB, being an incision-based procedure, involves more steps and is more time-consuming. Therefore, in routine gastroscopy and colonoscopy, there is still a lack of a dedicated instrument that can stably access, excise, and obtain relatively complete histological specimens from submucosal and deeper tissues without significantly increasing operational complexity.

[0005] In summary, there is an urgent need for a sampling device that is suitable for the working channel of conventional digestive endoscopy, is controllable in operation, and has high sampling efficiency. This device should be able to improve the problems of difficulty in obtaining deep lesion tissue, insufficient sample volume, and incomplete tissue structure while ensuring safety, so as to better meet the clinical needs for deep histological diagnosis. Summary of the Invention

[0006] The purpose of this invention is to provide a deep biopsy instrument for digestive endoscopy to solve the technical problems mentioned in the background art.

[0007] This invention provides a deep biopsy instrument for digestive endoscopy, including a deep cutting component, a fixing component, and a pushing cutting assembly. The deep cutting component, fixing component, and pushing cutting assembly are all purely mechanical drive structures that transmit power through manual force application and do not require external power or power transmission wires. The entire operation is achieved by mechanical transmission without any electric drive components or power participation. The deep cutting component is fitted inside the fixed component and can move along the axial direction of the fixed component. Its front end is provided with an annular cutting edge. It adopts the principle of a sleeve knife and achieves the cutting function through overall advancement. The pushing cutting component is set on one side inside the deep cutting component and has a dual driving function: on the one hand, its driving force is entirely provided by manual operation. Through the mechanical structure, the hand action is converted into driving the deep cutting component, which can drive the deep cutting component to advance along the axial direction of the fixed component to complete the cutting; on the other hand, it integrates a separation structure to achieve tissue separation. The deep cutting component has a groove, and the fixing component has a protrusion. The groove and the protrusion cooperate with each other to form a slidable connection between the deep cutting component and the fixing component. This sliding action is achieved by manually pushing the cutting component. The sliding speed and distance can be adjusted in real time according to the resistance felt by the hand. One end of the fixing component is a fixing groove, in which a fixing clip for holding pathological tissue is provided. The fixing clip directly clamps the tissue to achieve fixation. The other end of the fixing component is connected to a fixing clip drive assembly for controlling the opening and closing of the fixing clip. The fixing clip drive assembly drives the fixing clip to open and close by manually pulling or releasing. The clamping force can be directly controlled by the amount of force applied by the hand. The tail of the fixed component is driven by the push cutting assembly. The cutting end of the deep cutting component is provided with a separation structure for tissue separation. The separation structure is a serrated separation blade integrated into the push cutting assembly. The driving of the serrated separation blade and the advancement of the deep cutting component are both achieved by the push cutting assembly. The two are different functional modules of the same component. The inclination angle of the cutting part of the deep cutting component is 30°-60°. When the pushing cutting component moves inside the fixed component by manual operation, the annular blade at the front end of the deep cutting component is driven to advance and cut by the force applied by hand. Then, the tissue is separated by the separation structure. The cutting depth and force can be precisely controlled by hand operation.

[0008] In one embodiment of the present invention, the pushing cutting assembly includes a sliding collar, a first driving rod, a guide slider, two connecting ropes, two rope-threading posts, two elastic buttons, and a serrated cutting edge. The sliding collar is fitted into a groove provided in the fixed component. The bottom of the sliding collar is connected to one end of the first driving rod via a connecting block. The other end of the first driving rod is fixedly connected to the guide slider. The guide slider is slidably connected to a guide groove provided on the inner side of the deep cutting component. Through this slidable connection, the pushing cutting assembly can drive the deep cutting component to advance axially along the fixed component. The serrated cutting edge is located on the inner side of the cutting end of the deep cutting component. One end of each of the two connecting ropes is fixedly connected to both ends of the serrated cutting edge, and the two ends of the serrated cutting edge are movably connected in the mounting groove provided in the guide slider. The other ends of the two connecting ropes pass through the guide slider, the rope-threading posts, and the inner wall of the fixed component in sequence and are connected to the two elastic buttons respectively. Pressing the elastic buttons can pull the serrated cutting edge through the connecting ropes to complete the cutting, realizing the dual action of driving the pushing cutting assembly to advance and controlling the cutting.

[0009] In one embodiment of the present invention, the elastic button is installed in a key groove provided on the outside of the sliding collar. When the elastic button is pressed into the bottom of the key groove, the elastic button drives the connecting rope to pull the sawtooth cutting blade, and causes the sawtooth cutting blade to tighten and cut the tissue.

[0010] In one embodiment of the present invention, the connecting block is guided and slidably connected to the first strip groove of the fixing component, and the bottom end of the rope threading post is fixedly connected to the top of the first drive rod.

[0011] In one embodiment of the present invention, the fixing groove is an "arc-shaped bevel". The fixing clamp includes a rotating shaft and a clamp connected by the rotating shaft. The tail end of the clamp is connected to two Y-shaped connecting rods. One end of the two connecting rods is connected to a second drive rod by a pin. One end of the second drive rod passes through the fixing component and is connected to the fixing clamp drive assembly. The fixing clamp directly clamps the tissue by the clamp. The second drive rod drives the clamp to open and close around the rotating shaft by the Y-shaped connecting rod, thereby fixing the tissue.

[0012] In one embodiment of the present invention, the fixing clip driving assembly is a handle pull ring installed on the fixing component at the end away from the fixing clip, and the handle pull ring is connected to one end of the second driving rod via a pull cable.

[0013] In one embodiment of the present invention, scale lines are provided on the connection portion of the second drive rod and the fixing component.

[0014] Compared with the prior art, the beneficial effects of the present invention are: 1) This invention utilizes the groove and protrusion sliding fit structure of the deep cutting component and the fixing component, combined with the transmission design of the pushing cutting component, and the annular blade edge at the front end of the deep cutting component with a 30°-60° tilt angle, to achieve stable propulsion cutting of deep tissues using the principle of a cannula knife. Then, the serrated severing blade integrated into the pushing cutting component completes precise severing, solving the problems of traditional instruments being unable to penetrate deep tissues and having low cutting efficiency, and significantly improving the integrity and sampling accuracy of deep tissue samples. 2) This invention adopts a linkage structure between the fixed clamp drive assembly and the handle pull ring. The opening and closing of the fixed clamp is controlled by the second drive pull rod and the Y-shaped connecting rod. The fixed clamp is stably clamped with the "arc-shaped oblique opening" fixed clamp groove. At the same time, it is equipped with two parallel cutting methods: a serrated cutting blade and a tissue ligator. The two methods can be flexibly selected according to the clinical scenario to complete the tissue cutting in a coordinated manner, reducing the risk of bleeding. The overall structure simplifies the operation steps through the coordinated action of multiple components, improves the force transmission efficiency and operation controllability, adapts to the complex anatomical environment of the gastrointestinal tract, and meets the needs of accurate diagnosis. It has significant clinical practical value. 3) This invention adopts a purely manual mechanical drive design, eliminating the need for external power supply and power transmission wires. This eliminates the need for preoperative wiring connections and voltage adjustments, shortening preparation time and making it more adaptable. It can be used flexibly in primary healthcare institutions or emergency scenarios. Doctors can directly sense tissue resistance and clamping force through hand operation, achieving real-time force feedback control. This avoids over-cutting or improper clamping caused by the lack of force feedback in electric instruments. At the same time, the purely mechanical structure reduces the risk of electric component failure and eliminates the risk of electric burns caused by current leakage at the source, significantly improving operational safety and instrument reliability. Attached Figure Description

[0015] The accompanying drawings are provided to further illustrate the invention and form part of the specification. They are used together with the embodiments of the invention to explain the invention and do not constitute a limitation thereof.

[0016] In the attached diagram: Figure 1 This is a schematic diagram of the overall structure of the present invention; Figure 2 This is one of the overall structural schematic diagrams of the present invention; Figure 3 This is a schematic diagram of the fixing component structure of the present invention; Figure 4 This is an overall sectional view of the present invention; Figure 5This is a schematic diagram of the annular cutting edge structure of the present invention; Figure 6 This is a schematic diagram of the pushing and cutting component structure of the present invention; Figure 7 This is a schematic diagram of the sawtooth break-off blade structure of the present invention; Figure 8 This is a schematic diagram of the structure of Embodiment 2 of the present invention; Figure 9 This is a schematic diagram of the rope groove structure of the present invention; Figure 10 This is a schematic diagram of the tissue ligation device structure of the present invention.

[0017] In the diagram: 1. Deep cutting component; 101. Annular blade edge; 12. Guide groove; 2. Fixing component; 21. Fixing clamp groove; 22. Connecting part; 23. Groove; 3. Protrusion; 4. Groove; 5. First strip groove; 6. Fixing clamp; 61. Clamp; 62. Rotating shaft; 63. Pin; 64. Second drive rod; 65. Connecting rod; 7. Fixing clamp drive assembly; 71. Handle pull ring; 8. Push cutting assembly; 81. Sliding collar; 82. First drive rod; 83. Guide slider; 84. Connecting rope; 85. Rope threading post; 86. Elastic button; 87. Connecting block; 88. Serrated cutting blade; 9. Cutting mechanism; 91. Rope embedding groove; 92. Tissue ligator; 93. Second strip groove; 94. Operating handle. Detailed Implementation

[0018] The technical solutions of the embodiments of the present invention will be clearly and completely described below with reference to the accompanying drawings. Obviously, the described embodiments are only some embodiments of the present invention, and not all embodiments. Based on the embodiments of the present invention, all other embodiments obtained by those skilled in the art without creative effort are within the scope of protection of the present invention.

[0019] Example 1

[0020] Please see Figure 1-7 The present invention provides a deep biopsy instrument for digestive endoscopy, including a deep cutting component 1, a fixing component 2 and a pushing cutting assembly 8. The deep cutting component 1, the fixing component 2 and the pushing cutting assembly 8 are all pure mechanical drive structures that transmit power by manual force and do not require external power or power transmission wires. The entire operation is achieved by mechanical transmission without any electric drive components or power participation. The deep cutting component 1 is fitted inside the fixed component 2 and can move along the axial direction of the fixed component 2. Its front end is provided with an annular blade edge 101. Using the principle of a sleeve knife, it pushes the cutting component 8 to be set on one side inside the deep cutting component 1. It has a dual driving function: on the one hand, its driving force is entirely provided by manual operation. Through the mechanical structure, the hand action is converted into driving the deep cutting component 1, which can drive the deep cutting component 1 to advance along the axial direction of the fixed component 2 to complete the cutting; on the other hand, it integrates a serrated detachment blade 88 to realize tissue detachment. The deep cutting component 1 is provided with a groove 4, and the fixing component 2 is provided with a protrusion 3. The groove 4 and the protrusion 3 cooperate with each other to form a slidable connection between the deep cutting component 1 and the fixing component 2. This sliding action is achieved by manually pushing the cutting component 8. The sliding speed and distance can be adjusted in real time according to the resistance felt by the hand. One end of the fixing component 2 is a fixing groove 21, and a fixing clip 6 for holding pathological tissue is provided in the fixing groove 21. The fixing clip 6 directly clamps the tissue to achieve fixation. The other end of the fixing component 2 is connected to a fixing clip drive assembly 7 for controlling the opening and closing of the fixing clip 6. The fixing clip drive assembly 7 drives the fixing clip 6 to open and close by manually pulling or releasing. The clamping force can be directly controlled by the amount of force applied by the hand. The tail of the fixed component 2 is driven by the push cutting component 8. The cutting end of the deep cutting component 1 is provided with a serrated detachment blade 88 for tissue detachment. The serrated detachment blade 88 is integrated into the push cutting component 8. Its drive and the advancement of the deep cutting component 1 are both achieved by the push cutting component 8. The two are different functional modules of the same component, and there is no contradiction in function or use. The drive relies entirely on manual operation and does not require electrical assistance. The inclination angle of the cutting part of the deep cutting component 1 is 30°-60°. When the cutting component 8 is pushed to move inside the fixed component 2 by manual operation, the annular blade 101 at the front end of the deep cutting component 1 is driven to advance the cutting by the force applied by hand. Then, the tissue is separated by the serrated cutting blade 88. The cutting depth and force can be precisely controlled by hand operation. Specifically, in the context of gastrointestinal endoscopic biopsy for the diagnosis of gastrointestinal diseases, when doctors need to obtain samples of deep lesion tissue, they first insert the deep biopsy instrument into the target lesion area of ​​the patient's body through the endoscope channel. The doctor first operates the clamping drive assembly 7 at the connecting part 22 of the fixation component 2 to open the clamping clip 6 in the clamping groove 21, align it with the lesion tissue, and then close the clamping clip 6 to achieve initial stable clamping of the pathological tissue and prevent tissue displacement during subsequent cutting. Next, the doctor operates the pushing cutting assembly 8 at the tail of the fixation component 2. Through the sliding cooperation of the groove 4 and the protrusion 3, the deep cutting component 1 is driven to advance along the axis of the fixation component 2. The annular blade 101 at its front end cuts into the deep tissue using the principle of a cannula. Since the cutting part of the deep cutting component 1 has an inclination angle of 30°-60°, it can adapt to lesions of different depths and textures, reduce cutting resistance, and avoid tissue tearing. After the annular blade 101 is advanced to the preset cutting depth, the doctor presses the elastic button 86, and the connecting rope 84 pulls the serrated detachment blade 88 to tighten, accurately detaching the target tissue from the surrounding normal tissue. Finally, the deep tissue sample is obtained, solving the problems of traditional instruments being unable to penetrate deep layers and having low cutting efficiency. Throughout the biopsy procedure, all actions are performed manually by the physician. The physician directly applies force to the cutting component 8 and the clamping drive component 7 using their hands, allowing for real-time feedback on tissue resistance. When the annular blade 101 contacts deep tissues of varying hardness, the physician can judge the cutting depth by observing changes in the pushing force, preventing over-cutting due to a lack of force feedback from the electric instrument. The clamping force of the clamping clip 6 can also be precisely controlled by manually pulling the clamping drive component 7, preventing it from being too loose or too tight. Furthermore, the procedure eliminates the need for an external power supply and power transmission cables, simplifying the pre-operative circuit connection and voltage adjustment process for electric instruments. It also eliminates the risk of electrical burns to the digestive tract mucosa caused by current leakage, making it particularly suitable for primary healthcare institutions or emergency scenarios. The mechanical transmission structure also provides greater stability, reducing the risk of operational interruptions and ensuring the safety, accuracy, and efficiency of the deep biopsy process. In this embodiment, the tilt angle of the cutting portion of the deep cutting component 1 is 30°-60°. Specifically, when the instrument enters the patient's gastrointestinal tract, in the lesion area where the gastrointestinal tract is relatively shallow and the surrounding tissue is dense, a smaller tilt angle of about 30° can be selected to reduce the scraping and damage to the surrounding normal tissue when the annular blade 101 is advanced, while ensuring slow penetration into the tissue and precise positioning of the lesion site; while in the area where the lesion is deeper and the tissue texture is harder, a larger tilt angle of about 60° can be used, which can make it easier for the annular blade 101 to overcome tissue resistance and quickly reach the deep lesion site, thus improving cutting efficiency. In practice, doctors observe the lesion through endoscopy and, combined with clinical experience, manipulate the cutting component 8 to adjust the advancing force and speed of the deep cutting component 1, so that the annular blade 101 with the tilt angle can cut into the tissue in the optimal posture, ensuring that a pathological tissue sample of sufficient depth can be obtained, while minimizing trauma to the normal tissue inside the patient's gastrointestinal tract. In this embodiment, the pushing cutting assembly 8 includes a sliding collar 81, a first drive rod 82, a guide slider 83, two connecting ropes 84, two rope-threading posts 85, two elastic buttons 86, and a serrated cutting edge 88. The sliding collar 81 is fitted into the groove 23 provided in the fixed component 2. The bottom of the sliding collar 81 is connected to one end of the first drive rod 82 through a connecting block 87. The other end of the first drive rod 82 is fixedly connected to the guide slider 83. The guide slider 83 is slidably connected to the guide groove 12 provided on the inner side of the deep cutting component 1. Through this slidable connection, the pushing cutting assembly 8 can drive the deep cutting... The cutting component 1 is axially advanced along the fixed component 2. The serrated cutting edge 88 is located inside the cutting end of the deep cutting component 1. One end of each of the two connecting ropes 84 is fixedly connected to both ends of the serrated cutting edge 88. The two ends of the serrated cutting edge 88 are movably connected in the mounting groove provided in the guide slider 83. The other ends of the two connecting ropes 84 pass through the guide slider 83, the rope threading post 85 and the inner wall of the fixed component 2 in sequence and are connected to two elastic buttons 86 respectively. Pressing the elastic button 86 can pull the serrated cutting edge 88 through the connecting ropes 84 to complete the separation, realizing the dual function of "driving advancement + controlling separation" of the cutting component 8. Specifically, when the deep biopsy instrument of the digestive endoscope enters the lesion area of ​​the patient's gastrointestinal tract and needs to cut and separate the deep tissue, the doctor controls the first drive lever 82 to drive the sliding collar 81 to move along the slide groove 23, while the guide slider 83 slides along the guide slide groove 12 to achieve precise displacement of the entire cutting component 8, ensuring that the annular blade 101 at the front end of the deep cutting component 1 is aligned with the deep position of the lesion tissue. When tissue severance is required using the serrated cutting blade 88, the doctor presses the elastic button 86, which pulls the connecting rope 84 to move and tighten the serrated cutting blade 88 within the mounting groove, thereby precisely cutting deep tissue and ensuring the integrity of the sample. In this embodiment: the elastic button 86 is installed in the key groove provided on the outside of the sliding collar 81. When the elastic button 86 is pressed into the bottom of the key groove, the elastic button 86 drives the connecting rope 84 to pull the sawtooth cutting blade 88, and causes the sawtooth cutting blade 88 to tighten and cut the tissue. Specifically, when the doctor observes through the endoscope that the annular blade 101 has reached the preset cutting position of the deep lesion tissue and tissue transection is required, the doctor presses the elastic button 86 with his finger towards the bottom of the keyway groove. Since the elastic button 86 is connected to the connecting rope 84, the pressing action will drive the connecting rope 84 to generate tension. The connecting rope 84 transmits the tension to the serrated transection blade 88. Under the action of tension, the two ends of the serrated transection blade 88 move in the mounting groove of the guide slider 83. The serrated transection blade 88, which was originally in the unfolded state, gradually tightens. During the tightening process, the serrated transection blade 88 can fit more closely to the pathological tissue, accurately cut the deep tissue, and achieve effective transection of the pathological tissue. After the severance is completed, the doctor releases the elastic button 86. The elastic button 86 resets under its own elasticity, the tension of the connecting rope 84 disappears, and the serrated severance blade 88 also returns to its unfolded state using its own elasticity, preparing for the next operation or removal of the instrument, ensuring the efficiency and precision of deep tissue cutting and severance. In this embodiment: the connecting block 87 is guided and slidably connected to the first strip groove 5 provided in the fixing component 2, and the bottom end of the rope threading post 85 is fixedly connected to the top of the first drive rod 82. Specifically, during the deep tissue sampling operation using the deep biopsy instrument in the digestive endoscopy, when the doctor pulls the first drive lever 82 to move the sliding collar 81, the first strip groove 5 restricts and guides the movement direction of the connecting block 87, preventing the connecting block 87 from shifting during movement. This ensures that the sliding collar 81 can always slide stably along the groove 23 of the fixed component 2, avoiding the annular blade 101 of the deep cutting component 1 from failing to align with the lesion tissue due to the displacement of the sliding collar 81, thus affecting the cutting effect. At the same time, the rope threading post 85 ensures that the connecting rope 84 is always in a taut and stable state, ensuring that the pulling force generated when the doctor presses the elastic button 86 can be efficiently and accurately transmitted to the serrated cutting edge 88, allowing the serrated cutting edge 88 to tighten smoothly and complete tissue severance, ensuring the stability and reliability of the entire sampling process. In this embodiment: the fixing groove 21 is an "arc-shaped bevel". The fixing clamp 6 includes a rotating shaft 62 and a clamp 61 connected by the rotating shaft 62. The tail end of the clamp 61 is connected to two Y-shaped connecting rods 65. One end of the two connecting rods 65 is connected to a second drive rod 64 through a pin 63. One end of the second drive rod 64 passes through the fixing component 2 and is connected to the fixing clamp drive assembly 7. The fixing clamp 6 directly clamps the tissue through the clamp 61. The second drive rod 64 drives the clamp 61 to open and close around the rotating shaft 62 through the Y-shaped connecting rods 65 to achieve tissue fixation. Specifically, during the clamping operation of deep biopsy instruments in the digestive endoscopy for gastrointestinal lesions, the "arc-shaped oblique opening" design of the fixing groove 21, in conjunction with the structure of the fixing clamp 6, achieves stable and gentle clamping of the pathological tissue. When the fixing clamp 6 moves within the fixing clamp groove 21, it can better fit the tissue surface, reduce the pressure damage to the tissue, and at the same time increase the contact area with the tissue, improve the stability of clamping, and prevent the tissue from slipping during subsequent cutting and separation. When the doctor controls the movement of the second drive lever 64 via the fixation clamp drive assembly 7, the second drive lever 64 drives the two Y-shaped connecting rods 65 to move via the pin 63. The connecting rods 65 transmit the driving force to the clamp 61, causing the clamp 61 to rotate around the pivot 62, thus achieving the opening and closing action. When clamping tissue, the second drive lever 64 pushes forward, causing the clamp 61 to close via the connecting rods 65, tightly clamping the pathological tissue; after sampling is completed, the second drive lever 64 pulls backward, causing the connecting rods 65 to open the clamp 61, releasing the tissue, achieving precise and stable clamping of the tissue, laying the foundation for subsequent deep cutting and transection. In this embodiment: the fixed clamp drive assembly 7 is a handle pull ring 71 installed on the fixed part 2 away from the fixed clamp 6. The handle pull ring 71 is connected to one end of the second drive rod 64 by a pull cable. Specifically, in the clinical operation of deep biopsy instruments in digestive endoscopy, the fixation clip drive assembly 7 adopts the design of the handle pull ring 71, which greatly improves the convenience and control of doctors' operation and conforms to the operating habits of clinicians. The handle pull ring 71 is installed on the end of the fixing component 2 away from the fixing clip 6, so that the doctor can comfortably hold and apply force when manipulating the instrument through the endoscope outside the body; When the doctor needs to control the fixation clip 6 to hold the pathological tissue, he pulls the handle ring 71 with his finger. Since the cable is connected to the second drive rod 64, the pulling action will drive the second drive rod 64 to move into the fixation component 2. The second drive rod 64 transmits the driving force to the clamp 61 of the fixation clip 6 through the pin 63 and the Y-shaped connecting rod 65, causing the clamp 61 to rotate and close around the pivot 62, thereby clamping the diseased tissue. When it is necessary to release the tissue, the doctor releases the pulled handle ring 71. The handle ring 71 returns to its original position under its own elasticity or external restoring force, driving the second drive rod 64 to move out of the fixation component 2, and then drives the clamp 61 to open through the connecting rod 65, releasing the tissue. In this embodiment, scale lines are provided on the connection part 22 of the second drive rod 64 and the fixing component 2. Specifically, during the process of sampling deep lesions in the gastrointestinal tract using deep biopsy instruments in digestive endoscopy, the set scale lines provide important operational feedback for doctors, helping them to accurately control the clamping depth and force of the fixation clip 6, thereby improving the accuracy and safety of sampling. Example 2

[0021] Please refer to the following for details. Figure 8-10The core difference between this embodiment and embodiment 1 is that the cutting end of the deep cutting component 1 adopts an independently set disconnection mechanism 9 as the disconnection structure. The disconnection mechanism 9 includes a rope groove 91 opened at the cutting end of the deep cutting component 1. A tissue ligator 92 is embedded in the rope groove 91. The pull rope of the tissue ligator 92 passes through the second strip groove 93 provided in the shell wall of the deep cutting component 1 and is connected to an operating handle 94. In the scenario of gastrointestinal endoscopic biopsy for the diagnosis of gastrointestinal diseases, when the doctor uses the instrument of this embodiment to obtain deep lesion tissue samples, the initial operation is the same as in embodiment 1: first, the instrument is inserted into the target lesion area in the patient's body through the endoscope channel, the fixation clamp drive component 7 is operated to control the fixation clamp 6 to hold the lesion tissue, and then the push cutting component 8 is manipulated to drive the deep cutting component 1 to advance along the axis of the fixation component 2. The deep tissue is cut through the annular blade 101 at the front end using the principle of a cannula knife. The cutting depth is precisely controlled according to the 30°-60° tilt angle of the deep cutting component 1 and the hand resistance feedback. After the annular blade 101 completes the preset depth cut, the doctor observes and confirms the tissue location through endoscopy, and then operates the operating handle 94 of the transection mechanism 9: pushing the operating handle 94 forward, the rope moves along the second groove 93, causing the tissue ligator 92 to extend from the buried rope groove 91 and be placed around the root of the pathological tissue held by the fixation clip 6; then pulling the operating handle 94 backward and continuing to operate, tightening the tissue ligator 92, so that it is tightly wrapped around the root of the tissue, blocking the blood flow to the root of the tissue by ligation, and preventing a large amount of bleeding during the transection process; after the tissue ligator 92 continues to tighten until the tissue is completely cut off, the transection of the target tissue is completed, and then the doctor withdraws the instrument from the patient's body, completing the entire biopsy sampling process. The design of the ligation mechanism 9 not only ensures the complete acquisition of tissue samples, but also greatly improves the safety of the biopsy process and reduces the risk of complications. When the instrument is not performing the ligation operation, the tissue ligator 92 is embedded in the ligation groove 91 to avoid unnecessary contact and friction with the surrounding tissue, reduce interference and damage to the tissue, and further reduce the risk of complications. After the ligation is completed, the operating handle 94 is released, and the ligation rope of the tissue ligator 92 can be appropriately loosened, so that the ligated tissue sample can be taken out with the instrument for continued use after the next sampling.

[0022] The contents not described in detail in this description are existing technologies known to those skilled in the art. Although the present invention has been described in detail with reference to the foregoing embodiments, those skilled in the art can still modify the technical solutions described in the foregoing embodiments or make equivalent substitutions for some of the technical features. Any modifications, equivalent substitutions, improvements, etc., made within the spirit and principles of the present invention should be included within the protection scope of the present invention.

Claims

1. A deep biopsy instrument for digestive endoscopy, characterized in that, It includes a deep cutting component (1), a fixing component (2), and a pushing cutting assembly (8). The deep cutting component (1), the fixing component (2), and the pushing cutting assembly (8) are all pure mechanical drive structures that transmit power through manual force and do not require external power or power transmission wires. The entire operation is achieved by mechanical transmission without any electric drive components or power participation. The deep cutting component (1) is sleeved inside the fixed component (2) and can move along the axial direction of the fixed component (2). Its front end is provided with an annular blade edge (101). It adopts the principle of a sleeve knife and achieves the cutting function through overall advancement. The pushing cutting component (8) is set on one side inside the deep cutting component (1) and has a dual driving function: on the one hand, its driving force is entirely provided by manual operation. Through the mechanical structure, the hand action is converted into driving the deep cutting component (1), which can drive the deep cutting component (1) to advance along the axial direction of the fixed component (2) to complete the cutting; on the other hand, it integrates a separation structure to realize tissue separation. The deep cutting component (1) is provided with a groove (4), and the fixing component (2) is provided with a protrusion (3). The groove (4) and the protrusion (3) cooperate with each other to form a slidable connection between the deep cutting component (1) and the fixing component (2). This sliding action is achieved by manually pushing the cutting component (8). The sliding speed and distance can be adjusted in real time according to the resistance felt by the hand. One end of the fixing component (2) is a fixing groove (21), and a fixing clip (6) for holding pathological tissue is provided in the fixing groove (21). The fixing clip (6) directly clamps the tissue through the clip (61) to achieve fixation. The other end of the fixing component (2) is provided with a fixing clip drive assembly (7) for controlling the opening and closing of the fixing clip (6). The fixing clip drive assembly (7) drives the fixing clip (6) to open and close by manually pulling or releasing. The clamping force can be directly controlled by the amount of force applied by the hand. The tail of the fixed component (2) is driven by the push cutting component (8). The cutting end of the deep cutting component (1) is provided with a separation structure for tissue separation. The separation structure is a serrated separation blade (88) integrated into the push cutting component (8). The driving of the serrated separation blade (88) and the advancement of the deep cutting component (1) are both achieved by the push cutting component (8). The two are different functional modules of the same component. The inclination angle of the cutting part of the deep cutting component (1) is 30°-60°. When the pushing cutting component (8) moves inside the fixed component (2) by manual operation, the annular blade edge (101) at the front end of the deep cutting component (1) is driven to advance and cut by hand force. Then, the tissue is separated by the separation structure. The cutting depth and force can be precisely controlled by hand operation.

2. The deep biopsy instrument for digestive endoscopy according to claim 1, characterized in that: The pushing cutting assembly (8) includes a sliding collar (81), a first driving rod (82), a guide slider (83), two connecting ropes (84), two rope-threading posts (85), two elastic buttons (86), and a serrated cutting edge (88). The sliding collar (81) is fitted into a groove (23) provided in the fixed component (2). The bottom of the sliding collar (81) is connected to one end of the first driving rod (82) through a connecting block (87). The other end of the first driving rod (82) is fixedly connected to the guide slider (83). The guide slider (83) is slidably connected to a guide groove (12) provided on the inner side of the deep cutting component (1). Through this sliding connection, the pushing cutting assembly (8) can drive the deep cutting component (1) to move the deep cutting component (1). The layer cutting component (1) is axially advanced along the fixed component (2). The sawtooth cutting blade (88) is located inside the cutting end of the deep layer cutting component (1). One end of each of the two connecting ropes (84) is fixedly connected to both ends of the sawtooth cutting blade (88). The two ends of the sawtooth cutting blade (88) are movably connected in the mounting groove provided in the guide slider (83). The other ends of the two connecting ropes (84) pass through the guide slider (83), the rope threading post (85), and the inner wall of the fixed component (2) in sequence and are connected to two elastic buttons (86) respectively. Pressing the elastic button (86) can pull the sawtooth cutting blade (88) through the connecting rope (84) to complete the separation, realizing the dual action of driving the cutting component (8) to advance and controlling the separation.

3. The deep biopsy instrument for digestive endoscopy according to claim 2, characterized in that: The elastic button (86) is installed in the key groove provided on the outside of the sliding collar (81). When the elastic button (86) is pressed into the bottom of the key groove, the elastic button (86) drives the connecting rope (84) to pull the sawtooth cutting blade (88) and causes the sawtooth cutting blade (88) to tighten and cut the tissue.

4. The deep biopsy instrument for digestive endoscopy according to claim 2, characterized in that: The connecting block (87) is guided and slidably connected to the first strip groove (5) provided on the fixing component (2), and the bottom end of the rope threading column (85) is fixedly connected to the top of the first drive rod (82).

5. The deep biopsy instrument for digestive endoscopy according to claim 1, characterized in that: The fixing slot (21) is an "arc-shaped bevel". The fixing clamp (6) includes a rotating shaft (62) and a clamp (61) connected by the rotating shaft (62). The tail end of the clamp (61) is connected to two Y-shaped connecting rods (65). One end of the two connecting rods (65) is connected to a second drive rod (64) by a pin (63). One end of the second drive rod (64) passes through the fixing component (2) and is connected to the fixing clamp drive assembly (7). The fixing clamp (6) directly clamps the tissue through the clamp (61). The second drive rod (64) drives the clamp (61) to open and close around the rotating shaft (62) through the Y-shaped connecting rod (65) to achieve tissue fixation.

6. The deep biopsy instrument for digestive endoscopy according to claim 1, characterized in that: The fixed clamp drive assembly (7) is a handle pull ring (71) installed on the fixed part (2) away from the fixed clamp (6). The handle pull ring (71) is connected to one end of the second drive rod (64) by a pull cable.

7. The deep biopsy instrument for digestive endoscopy according to claim 6, characterized in that: The second drive rod (64) and the connection part (22) of the fixing component (2) are both provided with scale lines.

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