An endoscopic rotatable positioning pathological tissue precise cutting biopsy device

Abstract

The present application relates to the technical field of medical devices, and provides a pathological tissue precise cutting biopsy device capable of rotating and positioning under an endoscope, which comprises a control handle, a sheath connected to the distal end of the control handle, a core wire arranged in the sheath, a control assembly installed at the proximal end of the control handle for pushing and pulling the core wire to make it slide in the sheath, so as to realize linear tension transmission of the core wire, and a distal end base installed at the distal end of the sheath and having a catheter coaxially arranged on the inner wall of the distal end base. By converting linear tension into step rotation and rotary cutting power in situ at the distal end, the long pipe torsion lag and the bottleneck of end power transmission are completely overcome, precise fine positioning and low-cost minimally invasive rotary cutting are realized, and the combined capture system of negative pressure adsorption and flexible puncture buffer greatly improves the sampling success rate of complex lesions and effectively avoids tissue tearing and damage, so that the high unification of precise addressing, safe capture and non-destructive cutting is realized.

Description

Technical Field

[0001] This invention relates to the field of medical device technology, specifically to an endoscopic device for precise cutting and biopsy of pathological tissues that can be rotated and positioned. Background Technology

[0002] Endoscopic technology, as a core tool in modern minimally invasive medicine and early screening for gastrointestinal and respiratory tumors, is widely used for the observation and biopsy sampling of various intraluminal lesions. With the increasing demands for accurate early cancer diagnosis and high-quality pathological specimens in clinical practice, the endoscopic biopsy device—the core instrument of the endoscope—has become crucial in influencing the final pathological diagnosis due to its spatial positioning accuracy, specimen integrity, and tissue fidelity. However, traditional endoscopic biopsy forceps often rely on a purely rigid double-jaw occlusion and overall flexible tubing for positioning. In the extremely complex and slippery physiological environment of the internal cavity, existing equipment still faces many technical bottlenecks that urgently need to be addressed.

[0003] Many existing mainstream endoscopic flexible biopsy forceps often lack independent distal posture fine-tuning and protection mechanisms, resulting in a sluggish transmission state of long-distance "flexible shaft torsion" between the first and last components. During long-term clinical procedures, due to the lack of distal in-situ mechanical deflection, operators rely on the overall frictional torsion of a 2-meter-long spring catheter within the endoscopic forceps channel when adjusting the angle. Because of the extremely low torsional stiffness of the catheter, the torque input to the proximal end is often first converted into torsional deformation energy of the tube body. Once the accumulated energy exceeds the static friction threshold, the distal jaws release energy instantaneously and undergo uncontrollable, large-amplitude rotation, i.e., the "whipping effect," which severely affects the hit efficiency of small lesions. At the same time, the conventional jaw structure exerts violent radial compression on the tissue at the moment of closure, leading to cell rupture and morphological changes, which easily forms "tissue compression artifacts." This not only severely damages the original three-dimensional structure of the pathological specimen but also greatly interferes with subsequent microscopic diagnosis. In addition, when facing special lesions with slippery, flat, or easily slippery surfaces, the lack of a combined capture mechanism of active fluid traction and adaptive buffering means that the direct, rigid grasping of the metal jaws can easily lead to lesion slippage or tearing of the base, causing massive bleeding. If the goal is to introduce a "rotary cutting" process with minimal tissue damage, current industrial technology is limited by the violent heat and breakage caused by the high-speed rotation of the long-distance flexible shaft within the micro-diameter, as well as the size and sterilization challenges of the distal direct-drive micro-motor, making it impossible to achieve in terms of low-cost consumables. Therefore, there is an urgent need for a device for precise cutting and biopsy of pathological tissues that can be rotated and positioned under endoscopy. Summary of the Invention

[0004] To address the shortcomings of existing technologies, this invention provides an endoscopic rotatable positioning device for precise cutting and biopsy of pathological tissues. This device solves the problems commonly found in existing biopsy devices, such as the "whipping effect" caused by long tube torsion leading to loss of control in distal positioning, and the tendency for complex lesions to fall off and become traumatic due to forceful grasping.

[0005] To achieve the above objectives, the present invention provides the following technical solution: an endoscopic rotatable positioning device for precise cutting and biopsy of pathological tissue, comprising:

[0006] A control handle, the distal end of which is connected to an outer sheath, the outer sheath containing a core wire, and the proximal end of which is equipped with a control component for pushing and pulling the core wire to slide within the outer sheath, thereby achieving linear tension transmission of the core wire.

[0007] The distal base is installed at the distal end of the outer sheath. A catheter is coaxially arranged on the proximal end of its inner wall. A sleeve and a traction assembly are installed axially on the inner wall of the catheter. The distal end of the traction assembly slides axially on the inner wall of the sleeve so as to slide along the inner wall of the catheter by traction force. A positioning indexing assembly is installed at the middle of the inner wall of the distal base. A sleeve is arranged on one side of its proximal end. A stepping torsion assembly is arranged between the sleeve and the sleeve so as to convert linear motion into rotational torque on the positioning indexing assembly by the axial sliding of the sleeve.

[0008] The distal end is mounted on the distal end of the distal base. The distal end is connected to the positioning and indexing assembly via an outer tube. A push rod is connected to the distal side of the traction assembly. The push rod is connected to the sleeve via a spring sleeved on its outer wall. A blade holder is connected to the inner wall of the distal base via a guide groove assembly. A cutting blade is fixedly connected to the distal side of the blade holder. A linear rotary actuation assembly is provided on the proximal side of the blade holder to allow the blade holder to slide and rotate within the inner wall of the distal base through axial sliding of the push rod. An anchoring needle is coaxially mounted on the cutting blade via a deep groove ball bearing to cut pathological tissue. After entering the distal end, the cutting needle slides and anchors the tissue. A negative pressure adsorption assembly is provided on the bottom side of the inner wall of the distal base. The piston rod end is connected to the bottom side of the outer tube through a slider two. The top of the slider two is connected to the direct rotation actuation assembly so as to adsorb and position the pathological tissue synchronously when sliding with the blade holder. The hollow interior of the distal end forms a sampling cavity for accommodating live tissue specimens. After the cutting needle completes the rotational shearing, the dual locking action of the anchoring needle and the negative pressure adsorption assembly completely seals the cut pathological tissue in the sampling cavity, so that it can be removed from the body with the whole machine for use in ex vivo pathological diagnosis.

[0009] Preferably, the control component includes a slide handle coaxially disposed with the inner wall of the control handle, a bellows is provided at the proximal end of the slide handle, and an end cap is fixedly connected to the other end of the bellows. The inner wall of the end cap is connected to the core wire, so that the core wire can slide inside the outer sheath by pressing the end cap or pulling the slide handle.

[0010] Preferably, the traction assembly includes a slider that slides axially within the sleeve, a traction column is fixedly connected to one proximal end of the slider, and the other end of the traction column is connected to the core wire.

[0011] Preferably, the positioning and indexing assembly includes a ratchet fixedly connected to one side of the distal end of the sleeve and an end seat fixedly connected to the rear end of the outer tube. The inner side of the end seat has a pawl that slides through a spring to unidirectionally limit the rotation angle of the ratchet teeth.

[0012] Preferably, the stepping torsion assembly includes an inclined groove formed in the inner wall of the sleeve and a sliding ball fixedly connected to the outer wall of the sleeve, so as to deflect the linear traction force into rotational torque by causing the sliding ball to slide in the inclined groove through traction force.

[0013] Preferably, the guide groove assembly includes lugs fixedly connected to both sides of the outer wall of the tool holder and straight grooves formed on both sides of the inner wall of the outer tube. The distal ends of the lugs are connected through an annular groove so that the lugs can rotate on their inner walls.

[0014] Preferably, the direct rotary actuation assembly includes a central column fixedly connected to one side of the proximal end of the tool holder and a guide sleeve fixedly connected to the distal end of the push rod. The outer wall of the central column is provided with a large lead spiral groove, and the inner wall of the guide sleeve is fixedly connected with a protrusion adapted to the spiral groove, so that the central column can slide and rotate by the axial sliding of the guide sleeve.

[0015] Preferably, the negative pressure adsorption assembly includes a piston rod installed on the bottom side of the outer wall of the outer tube and a suction port opened on the bottom side of the inner wall of the distal end, wherein the suction port and the piston rod are connected by an air tube.

[0016] Preferably, the shaft of the anchoring needle is a slidingly sleeved double tube, which is connected by an internal spring, so that the anchoring needle has an elastic buffer stroke when it is inserted into the pathological tissue, avoiding excessive traction during the sliding advance and rotational shearing of the cutter, which would lead to tearing of the pathological tissue.

[0017] Preferably, the distal end of the cutter is provided with an annular cutting edge, and the edge of the annular cutting edge has a continuous wavy serrated structure to reduce the cutting resistance during rotational shearing and prevent tissue adhesion.

[0018] Working principle:

[0019] When locating lesions under endoscopy and adjusting the biopsy sampling angle, the operator first pulls the sliding handle at the proximal end of the control handle. The pulling force drives the mandrel inside the outer sheath to slide proximally through the bellows and end cap. The mandrel pulls the slider and cannula axially backward in the catheter through the traction column. At this time, the ball bearing on the outer wall of the cannula is forced to slide in the inclined groove on the inner wall of the cannula. The linear traction force of the mandrel is deflected into the rotational torque on the cannula by the inclined plane guiding action. When the cannula rotates, it drives the ratchet on the distal side to overcome the spring resistance of the pawl inside the end seat and step over it, realizing the one-way indexing limit of the rotation angle. Then, the distal tip is deflected through the outer tube until the distal tip is completely aligned with the target pathological tissue, completing the angle fine adjustment and positioning before biopsy.

[0020] Once the distal end is precisely positioned, the operator presses the end cap in the opposite direction to push the core wire to move distally. The thrust of the core wire is transmitted to the push rod through the traction component, causing the push rod to slide forward axially against the thrust of the outer wall spring. In the initial stage of advancement, the lugs on both sides of the outer wall of the blade holder are restricted by the straight groove on the inner wall of the outer tube, forcing the blade holder to advance only in a straight axial direction. During this process, the push rod, in conjunction with the linear rotation actuation component, pushes the slider two to move synchronously, pulling the piston column in the negative pressure adsorption component to draw outwards. This causes the suction port on the bottom side of the distal end to generate instantaneous negative pressure through the trachea, adsorbing and pulling the lesion tissue into the interior of the distal end. At the same time, the anchoring needle at the front end of the blade holder pierces into the pathological tissue. Since the shaft of the anchoring needle is a sliding double tube and is supported by a spring inside, it automatically contracts to generate an elastic buffer stroke when pierced, effectively avoiding tearing and damage to the fragile pathological tissue due to rigid impact or excessive traction during subsequent advancement and shearing.

[0021] As the push rod continues to advance deeper, the lugs on both sides of the blade holder slide out of the straight groove and enter the annular groove at the far end, releasing the restriction on the circumferential rotation of the blade holder. At this time, the convex head in the guide sleeve at the far end of the push rod forcibly pushes the large-lead spiral groove on the outer wall of the central column. Using the principle of spiral transmission, the linear axial thrust of the push rod is instantly converted into a high-speed rotational torque on the blade holder, driving the cutter to perform in-situ rotational shearing on the inner wall of the far-end base. The continuous wave-shaped serrated structure at the end of the cutter greatly reduces the cutting resistance and prevents adhesion, quickly cutting off the lesion tissue. During this period, the deep groove ball bearing ensures that the static anchoring state of the anchoring needle is not affected by the rotation of the cutter. After the biopsy is completed, the operator loosens the end cap, and the spring sleeved on the outer wall of the push rod quickly releases the accumulated elastic potential energy, pulling the push rod, blade holder and cutter back to their original position near the proximal end, completing the entire closed-loop biopsy operation from precise addressing and indexing, negative pressure adsorption buffering and anchoring to direct push rotary cutting sampling.

[0022] This invention provides an endoscopic, rotatable, and precisely positioned device for cutting and biopsiing pathological tissue. It offers the following advantages:

[0023] 1. This invention uses high-rigidity pure linear tension transmission to analyze and convert the linear displacement at the input end into a step-type rotational torque in situ at the farthest end. This avoids the technical dead end of low torsional stiffness in long tubes and enables controllable positioning of the far-end sampling window at extremely small angles under any bending path, greatly improving the reliability of clinical target hits.

[0024] 2. This invention utilizes the principle of local mechanical conversion to instantly convert the linear push-pull kinetic energy, which is most easily and stably transmitted over long distances, into the rotational speed and torque required to drive rotary cutting within a tiny space at the very end. This avoids the risks of flexible shaft overheating and electromagnetic interference from the motor, and successfully achieves rotary cutting sampling within the tiny space of an endoscope in the form of low-cost medical consumables.

[0025] 3. This invention introduces a composite capture system that integrates active fluid dynamics traction with adaptive flexible puncture. Before physical cutting, the system establishes a strong negative pressure adsorption field at the distal end, forcibly pulling and locking free or smooth tissues that are difficult to grasp into the optimal cutting area, ensuring a high success rate of one-time sampling. At the same time, its built-in puncture buffer anchoring mechanism can avoid iatrogenic secondary damage such as accidental tearing or massive bleeding of healthy tissue at the base of the lesion. Attached Figure Description

[0026] Figure 1 This is a perspective view of the present invention;

[0027] Figure 2 This is a schematic diagram showing the location of the distal base of the present invention;

[0028] Figure 3 This is a schematic diagram of the slider position according to the present invention;

[0029] Figure 4 This is a schematic diagram of the internal structure of the distal base of the present invention;

[0030] Figure 5 This is a schematic diagram of the catheter position according to the present invention;

[0031] Figure 6 This is a schematic diagram of the sleeve position according to the present invention;

[0032] Figure 7 This is a schematic diagram of the slider position of the present invention;

[0033] Figure 8 This is a schematic diagram of the ratchet position according to the present invention;

[0034] Figure 9 This is a schematic diagram of the central column structure of the present invention;

[0035] Figure 10 This is a schematic diagram of the annular groove structure of the present invention;

[0036] Figure 11 This is a schematic diagram showing the position of the piston rod in this invention;

[0037] Figure 12 This is a schematic diagram showing the position of the suction port in this invention;

[0038] Figure 13 This is a schematic diagram of the anchoring pin of the present invention.

[0039] The components are as follows: 1. Distal base; 2. Outer sheath; 3. Control handle; 4. Core wire; 501. Sliding handle; 502. Bellows; 503. End cap; 6. Distal head; 7. Guide tube; 801. Traction post; 802. Slider one; 9. Sleeve; 10. Push rod; 1101. Inclined groove; 1102. Sliding ball; 12. Sleeve seat; 1301. Ratchet; 1302. Pawl; 1303. End seat; 14. Outer tube; 1501. Guide sleeve; 1502. Protrusion; 1503. Central post; 16. Knife holder; 1701. Ear block; 1702. Straight groove; 1703. Annular groove; 18. Cutting knife; 19. Anchor pin; 20. Slider two; 2101. Piston post; 2102. Air tube; 2103. Suction port. Detailed Implementation

[0040] 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.

[0041] Example:

[0042] This invention provides an endoscopic rotatable positioning device for precise cutting and biopsy of pathological tissue, comprising:

[0043] Please see the appendix Figure 1 - Appendix Figure 3 The distal end of the control handle 3 is connected to an outer sheath 2, and a core wire 4 is disposed inside the outer sheath 2. A control component is installed at the proximal end of the control handle 3 for pushing and pulling the core wire 4 to slide inside the outer sheath 2, thereby realizing the linear tension transmission of the core wire 4. The control component includes a slide handle 501 coaxially disposed with the inner wall of the control handle 3. A bellows 502 is disposed at the proximal end of the slide handle 501. An end cap 503 is fixedly connected to the other end of the bellows 502. The inner wall of the end cap 503 is connected to the core wire 4 so that the core wire 4 can slide inside the outer sheath 2 by pressing the end cap 503 or pulling the slide handle 501.

[0044] Specifically, considering that endoscopic interventional medical devices are prone to direct contact with patient lesions, body fluids and blood, and are invasive devices with a high risk of hospital-acquired infections, the device of this invention must be subjected to standardized medical disinfection and sterilization procedures before and after clinical use. During use, the operator holds the control handle 3 outside the endoscope. When it is necessary to adjust the distal position or perform biopsy sampling, the operator can pull the sliding handle 501 proximally or press the end cap 503 distally to cause the bellows 502 to elastically compress or stretch. The pushing and pulling force directly acts on the core wire 4, so that the core wire 4 produces highly responsive axial sliding within the long outer sheath 2.

[0045] Please see the appendix Figure 5 - Appendix Figure 7 The distal base 1 is installed at the distal end of the outer sheath 2. A catheter 7 is coaxially arranged on the proximal end of its inner wall. A sleeve 9 and a traction assembly are installed on the inner wall of the catheter 7 along the axial direction. The distal end of the traction assembly slides axially on the inner wall of the sleeve 9 so as to slide along the inner wall of the catheter 7 by traction force. The traction assembly includes a slider 802 that slides axially in the sleeve 9. A traction column 801 is fixedly connected to one side of the proximal end of the slider 802. The other end of the traction column 801 is connected to the core wire 4.

[0046] Specifically, when the core wire 4 is forced to undergo linear displacement, its distal traction force directly acts on the traction column 801, causing the slider 802 to slide smoothly axially on the inner wall of the sleeve 9. The slider 802 then transmits work to the distal mechanism. Through the nested guide sliding cooperation between the slider 802 and the sleeve 9, the mechanical defects of the flexible core wire 4, which is prone to bending and buckling failure when subjected to distal thrust, are effectively overcome. The push-pull tension of the cable is converted into a highly stable rigid linear mechanical displacement inside the distal base 1, providing a reliable power input basis for subsequent rotational positioning and precise cutting actions.

[0047] Please see the appendix Figure 4 Appendix Figure 7 and attached Figure 8 A positioning and indexing assembly is installed in the middle of the inner wall of the distal base 1. The positioning and indexing assembly includes a ratchet 1301 fixedly connected to the distal side of the sleeve 12 and an end seat 1303 fixedly connected to the rear end of the outer tube 14. A pawl 1302 slides on the inner side of the end seat 1303 via a spring to limit the rotation angle of the tooth surface of the ratchet 1301 in one direction. A sleeve 12 is provided on the proximal side of the end seat 12. A stepping torsion assembly is provided between the sleeve 12 and the sleeve 9 to convert linear motion into rotational torque on the positioning and indexing assembly through axial sliding of the sleeve 9. The stepping torsion assembly includes a groove 1101 opened in the inner wall of the sleeve 12 and a ball bearing 1102 fixedly connected to the outer wall of the sleeve 9 to deflect the linear traction force into rotational torque by causing the ball bearing 1102 to slide in the groove 1101 through traction force.

[0048] Specifically, when locating lesions under direct endoscopic visualization, the mandrel 4 is pulled proximally to retract the cannula 9. The ball bearing 1102 is forced to slide in the inclined groove 1101, converting the linear tension into the rotational torque of the sleeve 12. This causes the ratchet 1301 to overcome the spring resistance of the pawl 1302 and pass the tooth position, allowing the outer tube 14 and the distal end 6 to undergo precise unidirectional stepping deflection, thus aligning the biopsy sampling window with the pathological tissue.

[0049] Please see the appendix Figure 9 and attached Figure 10 The distal end 6 is installed at the distal end of the distal base 1. The distal end 6 is connected to the positioning and indexing assembly through the outer tube 14. The distal end of the traction assembly is connected to the push rod 10. The push rod 10 is connected to the sleeve 9 through the spring sleeved on its outer wall. The inner wall of the distal base 1 is connected to the tool holder 16 through the guide slide group opened on its inner wall. The guide slide group includes ear blocks 1701 fixedly connected to both sides of the outer wall of the tool holder 16 and straight grooves 1702 opened on both sides of the inner wall of the outer tube 14. The distal end of the ear block 1701 is connected through the annular groove 1703 so that the ear block 1701 can rotate on its inner wall.

[0050] A cutter 18 is fixedly connected to the distal end of the cutter holder 16. The distal end of the cutter 18 is provided with an annular cutting edge, and the edge of the annular cutting edge has a continuous wavy serrated structure to reduce the cutting resistance during rotational shearing and prevent tissue adhesion. A linear rotary actuation assembly is provided on the proximal end of the cutter holder 16 to slide and rotate the cutter holder 16 on the inner wall of the distal base 1 through the axial sliding of the push rod 10. The linear rotary actuation assembly includes a central column 1503 fixedly connected to the proximal end of the cutter holder 16 and a guide sleeve 1501 fixedly connected to the distal end of the push rod 10. A large lead spiral groove is opened on the outer wall of the central column 1503. A protrusion 1502 adapted to the spiral groove is fixedly connected to the inner wall of the guide sleeve 1501 to slide and rotate the central column 1503 through the axial sliding of the guide sleeve 1501.

[0051] Specifically, after positioning, the core wire 4 is pushed back to the distal end. The thrust is advanced through the push rod 10. In the initial stage, the ear block 1701 is limited by the straight groove 1702, which forces the knife holder 16 and the cutter 18 to advance straight towards the lesion along the axial direction. When the ear block 1701 slides to the annular groove 1703, the linear displacement stops and the circumferential limitation is released. At this time, the push rod 10 continues to go deeper, and the protrusion 1502 in the guide sleeve 1501 forcefully pushes the large lead spiral groove on the outer wall of the central column 1503, instantly converting the linear thrust into the high-speed rotation of the knife holder 16. The cutter 18 then spins and cuts the tissue at high speed in place.

[0052] Please see the appendix Figure 11 - Appendix Figure 13The cutter 18 is coaxially equipped with an anchoring needle 19 via a deep groove ball bearing, so that after the pathological tissue enters the distal end head 6, it slides and anchors the tissue. The shaft of the anchoring needle 19 is a sliding double tube, which is connected by an internal spring, so that the anchoring needle 19 has an elastic buffer stroke when it pierces the pathological tissue, avoiding excessive traction during the sliding advance and rotational shearing of the cutter 18, which would cause the pathological tissue to tear.

[0053] A negative pressure adsorption assembly is provided on the bottom side of the inner wall of the distal base 1. The negative pressure adsorption assembly includes a piston column 2101 installed on the bottom side of the outer wall of the outer tube 14 and a suction port 2103 opened on the bottom side of the inner wall of the distal head 6. The suction port 2103 is connected to the piston column 2101 through a trachea 2102. The end of its piston rod is connected to the bottom side of the outer tube 14 through a slider 20. The top of the slider 20 is connected to the direct rotation actuation assembly so that the pathological tissue is adsorbed and positioned synchronously when sliding with the knife holder 16. The hollow interior of the distal head 6 forms a sampling cavity for accommodating live tissue specimens. After the cutter 18 completes the rotational cutting, the cut pathological tissue is completely sealed in the sampling cavity with the double locking action of the anchoring needle 19 and the negative pressure adsorption assembly, so that it can be removed from the body with the whole machine for use in ex vivo pathological diagnosis.

[0054] Specifically, in the initial stage when the blade holder 16 is driven forward by the push rod 10, the slider 20 is synchronously linked and pulls the piston column 2101 outward to perform a suction action, so that the suction port 2103 generates a local negative pressure through the trachea 2102, which strongly adsorbs and pulls the diseased tissue into the distal end head 6; at the same time, the anchoring needle 19 pierces into the center of the aspirated tissue, and its double tube shaft part relies on the internal spring to adaptively contract and retract, absorbing the rigid piercing impact; when the cutter 18 enters the high-speed rotating shearing stage, the deep groove ball bearing isolates the rotational torque of the cutter 18, so that the anchoring needle 19 always remains stationary and firmly grasps the tissue;

[0055] To meet stringent medical disinfection requirements, in terms of structural and material adaptability, the outer shell of the control handle 3, the outer sheath 2, and the blood / liquid-contact components such as the distal end 6 are preferably made of medical-grade high-temperature resistant, chemically resistant, and highly biocompatible polymer materials such as medical-grade polyether ether ketone (PEEK), polytetrafluoroethylene (PTFE), and 316L medical stainless steel. At the same time, the connection between the distal base 1 and each moving part adopts a smooth transition design without dead corners or with rounded corners to reduce the residual blind spots of biological load.

[0056] Before clinical use, this device can perfectly withstand low-temperature sterilization with ethylene oxide (EO) or high-level medical sterilization with hydrogen peroxide plasma, allowing it to be inserted into the patient's body through the endoscopic forceps channel in an absolutely sterile state. After sampling, thanks to the physical sealing and isolation design of the proximal bellows 502 on the core components inside the control handle 3, capillary siphoning and deep backflow penetration of patient fluids, blood, and tiny cutting debris into the operating handle is effectively blocked. This allows operators to easily flush and perform secondary high-level medical disinfection of the external tubing and distal mechanical structure after removing the instrument.

[0057] It should be noted that, since the present invention relates to a minimally invasive interventional medical device applied within the endoscopic biopsy forceps channel, its actual overall outer diameter is subject to strict physical limitations. In order to clearly and intuitively demonstrate the complex mechanical transmission logic within the extremely small space at the distal end in the accompanying drawings, all the accompanying drawings of the present invention employ engineering drawing techniques such as non-proportional enlargement, exaggeration of local dimensions, and simplification of schematic structures.

[0058] Therefore, the visual dimensional relationships of the components shown in the attached drawings, such as wall thickness, pipe diameter, mechanical clearance, spring wire diameter, and length-to-diameter ratio, are purely for the purpose of illustrating their working principle and kinematic connection relationship in conjunction with the instruction manual, and do not represent the actual physical dimensions or absolute geometric proportions of the actual clinical medical consumables during industrial production and processing.

[0059] Although embodiments of the invention have been shown and described, it will be understood by those skilled in the art that various changes, modifications, substitutions and alterations can be made to these embodiments without departing from the principles and spirit of the invention, the scope of which is defined by the appended claims and their equivalents.

Claims

1. An endoscopic rotatable positioning device for precise cutting and biopsy of pathological tissue, characterized in that, include: The control handle (3) is connected to an outer sheath (2) at its distal end. The outer sheath (2) is a flexible, slender tube with an outer diameter adapted to the biopsy forceps channel of the endoscope, so as to pass through the biopsy forceps channel and penetrate into the human body cavity. A core wire (4) is provided inside the outer sheath (2). A control component is installed at the proximal end of the control handle (3) for pushing and pulling the core wire (4) to make it slide inside the outer sheath (2), thereby realizing the linear tension transmission of the core wire (4). The distal base (1) is installed at the distal end of the outer sheath (2). A catheter (7) is coaxially arranged on the proximal end of the inner wall of the catheter (7). A sleeve (9) and a traction assembly are installed axially on the inner wall of the catheter (7). The traction assembly includes a slider (802) that slides axially within the sleeve (9). A traction column (801) is fixedly connected to one proximal side of the slider (802). The other end of the traction column (801) is connected to the core wire (4). The distal end of the traction assembly slides axially on the inner wall of the sleeve (9) so that it slides along the inner wall of the catheter (7) by traction force. The distal base (1) has a positioning indexing component installed in the middle of its inner wall, and a sleeve (12) is provided on its proximal side. A stepping torsion component is provided between the sleeve (12) and the sleeve (9) to convert linear motion into rotational torque on the positioning indexing component through the axial sliding of the sleeve (9). The stepping torsion component includes a groove (1101) opened in the inner wall of the sleeve (12) and a ball bearing (1102) fixedly connected to the outer wall of the sleeve (9) to deflect the linear traction force into rotational torque by causing the ball bearing (1102) to slide in the groove (1101) through traction force. The distal end (6) is installed at the distal end of the distal base (1). The distal end (6) is connected to the positioning and indexing assembly via an outer tube (14). A push rod (10) is connected to one side of the distal end of the traction assembly. The push rod (10) is connected to the sleeve (9) via a spring sleeved on its outer wall. The inner wall of the distal base (1) is connected to the tool holder (16) via a guide groove assembly. The guide groove assembly includes lugs (1701) fixedly connected to both sides of the outer wall of the tool holder (16) and lugs (1701) opened on both sides of the inner wall of the outer tube (14). A straight groove (1702) is provided, and the distal end of the ear block (1701) is connected through an annular groove (1703) to allow the ear block (1701) to rotate on its inner wall. A cutter (18) is fixedly connected to the distal side of the cutter holder (16), and a straight rotary actuation assembly is provided on the proximal side of the cutter holder (16) to allow the cutter holder (16) to slide and rotate on the inner wall of the distal base (1) by axial sliding of the push rod (10). The straight rotary actuation assembly includes a central column (1503) fixedly connected to the proximal side of the cutter holder (16) and a central column (1503) fixedly connected to the push rod (1703). 0) The guide sleeve (1501) at the distal end, the outer wall of the central column (1503) is provided with a large lead spiral groove, and the inner wall of the guide sleeve (1501) is fixedly connected with a protrusion (1502) that matches the spiral groove, so that the central column (1503) can slide and rotate by the axial sliding of the guide sleeve (1501). The cutter (18) is coaxially provided with an anchoring needle (19) through a deep groove ball bearing, so as to anchor the pathological tissue as it slides with the cutter (18) after entering the distal head (6). The bottom side of the inner wall of the distal base (1) is provided with a negative pressure adsorption component. The piston rod end is connected to the bottom side of the outer tube (14) via slider two (20). The top of slider two (20) is connected to the direct rotation actuation component so that the pathological tissue is simultaneously adsorbed and positioned when sliding with the knife holder (16). The hollow interior of the distal head (6) forms a sampling cavity for accommodating live tissue specimens. After the cutter (18) completes the rotational cutting, the cut pathological tissue is completely sealed in the sampling cavity with the double locking effect of the anchoring needle (19) and the negative pressure adsorption component, so that it can be removed from the body with the whole machine for use in ex vivo pathological diagnosis.

2. The endoscopic rotatable positioning device for precise cutting and biopsy of pathological tissue according to claim 1, characterized in that, The control assembly includes a slide (501) coaxially disposed with the inner wall of the control handle (3). A bellows (502) is provided at the proximal end of the slide (501). An end cap (503) is fixedly connected to the other end of the bellows (502). The inner wall of the end cap (503) is connected to the core wire (4) so ​​that the core wire (4) can slide inside the outer sheath (2) by pressing the end cap (503) or pulling the slide (501).

3. The endoscopic rotatable positioning device for precise cutting and biopsy of pathological tissue according to claim 1, characterized in that, The positioning and indexing assembly includes a ratchet (1301) fixedly connected to one side of the far end of the sleeve (12) and an end seat (1303) fixedly connected to the rear end of the outer tube (14). The inner side of the end seat (1303) has a pawl (1302) that slides through a spring to limit the rotation angle of the tooth surface of the ratchet (1301) in one direction.

4. The endoscopic rotatable positioning device for precise cutting and biopsy of pathological tissue according to claim 1, characterized in that, The negative pressure adsorption assembly includes a piston column (2101) installed on the bottom side of the outer wall of the outer tube (14) and a suction port (2103) opened on the bottom side of the inner wall of the distal end (6). The suction port (2103) and the piston column (2101) are connected by an air tube (2102).

5. The endoscopic rotatable positioning device for precise cutting and biopsy of pathological tissue according to claim 1, characterized in that, The shaft of the anchoring needle (19) is a sliding double tube connected by an internal spring, so that the anchoring needle (19) has an elastic buffer stroke when it is inserted into the pathological tissue, avoiding excessive traction during the sliding advance and rotational shearing of the cutter (18) and causing the pathological tissue to tear.

6. The endoscopic rotatable positioning device for precise cutting and biopsy of pathological tissue according to claim 1, characterized in that, The distal end of the cutter (18) is provided with an annular cutting edge, and the edge of the annular cutting edge has a continuous wavy serrated structure to reduce the cutting resistance during rotational shearing and prevent tissue adhesion.

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