An anti-displacement fixator for endoscopic surgery

Abstract

This invention provides an anti-displacement fixator for endoscopic surgery. Through designs including fixed-end directional constraint, multi-axis adjuster for flexible adjustment, positioning pin locking, and adaptable elastic fastening components, the fixed end restricts the endoscope's movement along its central axis via a sleeve. Combined with an elastic strip and fastening nut, temporary intraoperative fixation is achieved to prevent unintended displacement. The positioning pin and arc-shaped block on the ball sleeve can fix single-axis movement during intraoperative observation and pausing, offering convenient operation and reliable locking. The snap-on installation facilitates disassembly, and the elastic sleeve diameter is adjustable to accommodate different types (colonoscopes / gastroscopes) and diameters of endoscopes. This effectively solves problems such as unstable operation, limited adjustment, and poor compatibility in existing endoscopic surgeries, improving surgical precision and safety. This application can reduce surgical manpower, allowing a single surgeon to perform precise operations without needing to use their right hand for support, freeing up their right hand for easier scalpel control, and eliminating the need for another surgeon to hold the endoscope, thus saving the manpower of one surgeon.

Description

Technical Field

[0001] This invention relates to the field of medical surgical aids, and in particular to an anti-displacement fixator for endoscopic surgery. Background Technology

[0002] In endoscopic submucosal dissection (ESD) procedures, such as gastroscopy or colonoscopy, the surgeon inserts an endoscope (gastroscope or colonoscope) through the body's natural cavities. The surgeon uses a camera at the end of the endoscope to observe the location of the lesion while simultaneously manipulating surgical instruments (such as electrosurgical units and hemostatic forceps) within the instrument channel to dissect the tissue. During the procedure, the endoscope angle and depth must be repeatedly adjusted to obtain a clear view. The endoscope must be kept relatively stable during the dissection process to avoid visual disturbances that could affect the precision of the procedure.

[0003] However, in clinical practice, the following technical defects have been found in the above-mentioned endoscopic ESD or colonoscopy ESD procedures: the inability to fix the endoscope. Unable to fix: During ESD surgery, the surgeon needs to control the size knob with his left hand and operate the high-frequency electrosurgical unit and hemostat with his right hand. Therefore, there is no hand to fix the colonoscope. At this time, another doctor is needed to control and hold the endoscope, which increases the manpower required for endoscopic surgery. Insufficient operational stability: Reliance on the surgeon's hand to hold the endoscope can easily lead to hand fatigue during prolonged operation, causing unexpected displacement of the endoscope and affecting the stability of the surgical field; Limited multi-degree-of-freedom adjustment: Traditional fixation methods (such as simple stents) cannot achieve flexible adjustment in multiple directions, making it difficult to adapt to the needs of different patient positions and surgical sites; Difficulty in intraoperative observation and pausing: The lack of a temporary fixation mechanism makes it easy for the endoscope to shift due to external forces (such as patient breathing or changes in body position) when observation or delicate operations are required, increasing surgical risks. Poor compatibility: Different models of endoscopes have significantly different diameters, and traditional fixation devices are difficult to adapt to various types of endoscopes. When changing them, the fixation components need to be readjusted or replaced. Summary of the Invention

[0004] To address the technical problems existing in the prior art, the present invention provides the following technical solution: An anti-displacement fixation device for endoscopic surgery is used to secure an endoscope 7 during surgery to the surgical site. The endoscope is an colonoscope or a gastroscope. The fixation device includes: Fixed end 6, detachable for clinical use; The endoscope 7 is fitted onto the fixed end 6 and maintains directional movement with the fixed end 6 during the procedure.

[0005] Preferably, the fixator further includes: A flexible stent is positioned between the clinical area and the fixed end 6 to provide the fixed end 6 with a multi-degree-of-freedom adjustment space.

[0006] Preferably, the flexible stent includes a snap fastener 1, a sub-stent 2, and a multi-axis adjuster. The sub-stent 2 is connected between the snap fastener 1 and the multi-axis adjuster. The snap fastener 1 is movably locked in place clinically. The fixed end 6 is located at the end of the multi-axis adjuster.

[0007] Preferably, the multi-axis adjuster includes an X-axis adjuster 3, a Y-axis adjuster 4, and a Z-axis adjuster 5, with the three-axis connectors connected end-to-end in sequence.

[0008] Preferably, the X-axis adjuster 3, Y-axis adjuster 4 and Z-axis adjuster 5 are all tie rod ball head structures. The structure includes a ball head 10 with a tie rod 11 and a ball sleeve 9 for restraining the ball head 10. The ball head 10 is restricted to X-axis, Y-axis or Z-axis movement by the ball sleeve 9.

[0009] Preferably, the ball sleeve 9 has a threaded hole 8 at its bottom, and the end of the pull rod 11 has an external thread that matches the threaded hole 8; The X-axis adjuster 3 and the Y-axis adjuster 4, as well as the Y-axis adjuster 4 and the Z-axis adjuster 5, are connected to each other by threaded structures.

[0010] Preferably, the ball sleeve 9 body is further provided with a positioning pin 13, and the end of the positioning pin 13 is provided with an arc-shaped block 12 that can move relative to the ball head 10. When it is necessary to observe and stay during the operation, the positioning pin 13 is tightened, and the arc-shaped block 12 is pressed against the ball head 10 and the axis movement is fixed.

[0011] Preferably, the fixed end 6 includes a sleeve 601 that fits into the end of the flexible support, the endoscope 7 is fitted in the sleeve 601, the endoscope 7 is confined in the sleeve 601 and moves along the central axis of the sleeve 601.

[0012] Preferably, the fixed end 6 further includes an endoscope fastening assembly for fixing the endoscope 7 to the sleeve 601 during intraoperative observation.

[0013] Preferably, the endoscope fastening assembly includes elastic strips 603 and fastening nuts 602. Multiple elastic strips 603 are circumferentially distributed on the left end face of the sleeve 601. Each elastic strip 603 has a radially arranged interlocking tooth 604 at its end, which closes to form an adjustable-diameter elastic cylinder. The endoscope 7 passes through the sleeve 601 and the elastic cylinder sequentially. The fastening nut 602 engages with the outer surface of the elastic cylinder. When the fastening nut 602 is tightened to the left relative to the elastic cylinder, the interlocking tooth 604 clamps the endoscope 7, thus securing it. Conversely, tightening it to the right releases the endoscope 7. When the endoscope 7 needs to be replaced, the diameter can be adjusted according to the type of endoscope 7 being replaced. The beneficial effects of the technical solutions provided in the embodiments of the present invention include at least the following: This invention effectively solves the problems of unstable operation, limited adjustment, and poor compatibility in existing endoscopic surgery by using designs such as fixed-end directional constraint, multi-axis adjuster for flexible adjustment, positioning pin locking, and elastic fastening component adaptation, thereby improving surgical precision and safety.

[0014] 1. Reduced surgical manpower: Based on the use of the fixator in this application, the endoscope can be fixed in a restrictive manner, allowing the surgeon to perform precise operations by one person without needing to support it with his right hand, freeing up his right hand, making it easier to control the scalpel, saving the need for another surgeon to hold the endoscope, thus saving the manpower of one surgeon; 2. Directional movement and stable fixation: The fixed end restricts the movement of the endoscope along the central axis through a sleeve, and temporary fixation during the operation is achieved in conjunction with elastic strips and fastening nuts to avoid unexpected movement; 3. Flexible adjustment with multiple degrees of freedom: The flexible support includes X, Y, and Z axis adjusters (pull rod ball head structure), which can realize independent adjustment in three directions, and the stability is ensured by the threaded structure connection.

[0015] 4. Quick positioning and locking: The positioning pins and arc-shaped blocks on the ball sleeve can fix the single-axis movement during intraoperative observation and pausing, making operation convenient and locking reliable.

[0016] 5. Compatibility and detachable design: The snap-on installation makes it easy to disassemble, and the flexible tube diameter is adjustable to accommodate different types (colonoscopes / gastroscopes) and diameters of endoscopes. Attached Figure Description

[0017] To more clearly illustrate the technical solutions in the embodiments of the present invention, the accompanying drawings used in the description of the embodiments will be briefly introduced below. Obviously, the accompanying drawings described below are only some embodiments of the present invention. For those skilled in the art, other drawings can be obtained based on these drawings without creative effort.

[0018] Figure 1This is a schematic diagram illustrating the application principle of an anti-displacement fixator for endoscopic surgery provided in an embodiment of the present invention; Figure 2 This is a schematic diagram of a tie rod ball joint structure provided in an embodiment of the present invention; Figure 3 This is a schematic diagram of the structure of an endoscope fastening assembly provided in an embodiment of the present invention; Figure 4 yes Figure 3 The left view. Detailed Implementation

[0019] The technical solution of the present invention will now be described with reference to the accompanying drawings.

[0020] In embodiments of the present invention, words such as "exemplarily," "for example," etc., are used to indicate that something is an example, illustration, or description. Any embodiment or design described as "exemplary" in the present invention should not be construed as being more preferred or advantageous than other embodiments or designs. Specifically, the use of the word "exemplary" is intended to present the concept in a concrete manner. Furthermore, in embodiments of the present invention, the meaning expressed by "and / or" can be both, or either one.

[0021] In the embodiments of this invention, the terms "image" and "picture" may sometimes be used interchangeably. It should be noted that, without emphasizing the distinction between them, they convey the same meaning. Similarly, the terms "of," "corresponding (relevant)," and "corresponding" may sometimes be used interchangeably. It should be noted that, without emphasizing the distinction between them, they convey the same meaning.

[0022] In this embodiment of the invention, sometimes a subscript such as W1 may be mistakenly written as a non-subscript form such as W1. When the difference is not emphasized, the meaning they express is the same.

[0023] To make the technical problems, technical solutions and advantages of the present invention clearer, a detailed description will be given below in conjunction with the accompanying drawings and specific embodiments.

[0024] An anti-displacement fixation device for endoscopic surgery is used to restrain an endoscope 7 during surgery on the operating table. The endoscope is a colonoscope or a gastroscope. The fixation device includes a modular component that achieves mechanical fixation and directional restraint of the endoscope. During implementation, the fixed end is first assembled with a flexible support, and then fixed to the edge of the operating table through a snap-fit ​​structure. It is compatible with mainstream models such as the Olympus GIF-H290 gastroscope or CF-H290AI colonoscope, and ultimately achieves a stable effect with an intraoperative endoscope displacement of ≤0.5mm.

[0025] Fixed end 6 is detachable and can be installed in clinical settings. It adopts a quick-release buckle structure (such as the medical-grade plastic buckle of model K-01), which can be quickly connected / separated from the operating table guide by pressing the release button. The installation time is ≤15 seconds, and the disassembly force must reach more than 150N to ensure that there is no risk of loosening during the operation.

[0026] The endoscope 7 is fitted onto the fixed end 6 and maintains directional movement with the fixed end 6 during the operation. The working principle is based on the clearance fit between the sleeve and the endoscope (fitting tolerance H7 / g6). During implementation, the endoscope can slide axially along the central axis of the sleeve by ±30mm, and the radial offset is controlled within 0.2mm to ensure the relative alignment accuracy between the surgical instrument channel and the lesion position.

[0027] Preferably, the fixator further includes: a flexible support system that achieves spatial positioning through multi-joint series connection, made of 2024 aluminum alloy, with an overall weight ≤500g and a load capacity ≥2kg, meeting the mechanical performance requirements during endoscopic operation.

[0028] A flexible support, positioned between the clinical area and the fixed end 6, provides the fixed end 6 with a multi-degree-of-freedom adjustment space. It is engaged with the operating table crossbar via a snap-fit ​​1 (opening size adjustable from 30-50mm), and the secondary support 2 (200mm in length) connects to a multi-axis adjuster, enabling ±90° rotation adjustment of the fixed end in three-dimensional space with an adjustment resolution of 1°, meeting the visual requirements of different surgical positions.

[0029] Preferably, the flexible stent includes a snap fastener 1, a sub-stent 2, and a multi-axis adjuster. The sub-stent 2 is connected between the snap fastener 1 and the multi-axis adjuster. The snap fastener 1 is movably engaged in clinical position, and the fixed end 6 is located at the end of the multi-axis adjuster. The snap fastener 1 adopts a spring-loaded locking structure with a continuously adjustable clamping force of 50-80N. The sub-stent 2 is connected to the multi-axis adjuster via an M8 internal thread, and axial positioning is achieved with the help of an anti-loosening nut. After assembly, the coaxiality error is ≤0.1mm / m.

[0030] Preferably, the multi-axis adjuster includes an X-axis adjuster 3, a Y-axis adjuster 4, and a Z-axis adjuster 5, with the three-axis connectors connected end-to-end in sequence. The three-axis adjusters adopt a series layout, with X-axis (horizontal rotation), Y-axis (pitch adjustment), and Z-axis (axial extension) travels of ±45°, ±30°, and 50mm respectively. Each axis is independently locked, eliminating coupling interference during adjustment, and achieving a positioning repeatability accuracy of 0.5mm. Refer to the application diagram of the ball joint structure of an automotive steering gear tie rod.

[0031] Preferably, the X-axis adjuster 3, Y-axis adjuster 4, and Z-axis adjuster 5 are all tie-rod ball joint structures. This structure includes a ball joint 10 with a tie rod 11 and a ball sleeve 9 for restraining the ball joint 10. The ball joint 10 is restricted to X-axis, Y-axis, or Z-axis movement by the ball sleeve 9. The ball joint 10 has a diameter of 12mm (tolerance ±0.02mm), the ball sleeve 9 uses a polytetrafluoroethylene bushing with a clearance of 0.05-0.1mm, and the tie rod 11 has a diameter of 8mm. A single-axis rotation angle of ±45° is achieved through the ball joint universal joint, with a movement resistance of 1.5-2.5 N·m, ensuring a smooth operating feel.

[0032] Preferably, the bottom of the ball sleeve 9 is provided with a threaded hole 8, and the end of the pull rod 11 is provided with an external thread that matches the threaded hole 8; the threaded hole 8 is an M10×1.25 fine thread, and the length of the external thread at the end of the pull rod 11 is 15mm. It is used in conjunction with thread locking adhesive (such as Loctite 243) to ensure a connection strength ≥200N·m and prevent loosening due to vibration during surgery.

[0033] The X-axis adjuster 3 and the Y-axis adjuster 4, as well as the Y-axis adjuster 4 and the Z-axis adjuster 5, are connected by threaded connections. M12×1.5 metric threads are used, with a thread engagement length of 20mm. The assembly torque is controlled at 35-40 N·m, and a locking washer is used to prevent loosening. After 5000 adjustment tests, no stripping was observed in the threaded connections.

[0034] Preferably, the ball sleeve 9 body is further provided with a positioning pin 13, and the end of the positioning pin 13 is provided with an arc-shaped block 12 that can move relative to the ball head 10. When intraoperative observation is required, the positioning pin 13 is tightened, and the arc-shaped block 12 is pressed against the ball head 10 to fix the shaft movement. The positioning pin 13 is an M6×16 hexagon socket head cap screw, and the arc-shaped block 12 is made of 65Mn spring steel (hardness HRC40-45). The contact pressure when locked is ≥2MPa, and the unlocking force is ≤30N, realizing quick locking / unlocking with one hand. After locking, the shaft system wobble is ≤0.1mm.

[0035] Preferably, the fixed end 6 includes a sleeve 601 that fits into the end of the flexible support. The endoscope 7 is fitted within the sleeve 601, and is confined within the sleeve 601, moving along the central axis of the sleeve 601. The sleeve 601 is made of 304 stainless steel, with an inner diameter of 12mm (tolerance H8), a length of 80mm, an inner wall finish of Ra0.8μm, an endoscope insertion resistance ≤5N, and axial movement smoothness meeting the ISO 10993 biocompatibility standard.

[0036] Preferably, the fixed end 6 further includes an endoscope fastening assembly for fixing the endoscope 7 to the sleeve 601 during intraoperative observation. The fastening assembly adopts a radially encircling structure, generating a clamping force through elastic deformation. When fixed, the radial deformation of the endoscope is ≤0.1mm, meeting the accuracy requirements of the endoscopic optical system. In the fixed state, the axial tensile force must be ≥50N for movement.

[0037] Preferably, the endoscope fastening assembly includes elastic strips 603 and fastening nuts 602. Multiple elastic strips 603 are circumferentially distributed on the left end face of the sleeve 601. Each elastic strip 603 has a radially arranged interlocking tooth 604 at its end, which closes to form an adjustable-diameter elastic cylinder. The endoscope 7 passes through the sleeve 601 and the elastic cylinder sequentially. The fastening nut 602 engages with the outer surface of the elastic cylinder. When the fastening nut 602 is tightened to the left relative to the elastic cylinder, the interlocking tooth 604 clamps the endoscope 7, thus securing it. Conversely, tightening it to the right releases the endoscope 7. When the endoscope 7 needs to be replaced, the diameter can be adjusted according to the type of endoscope 7 being replaced. The elastic strip 603 is made of medical-grade silicone (Shore hardness 60±5A), with three strips evenly distributed at 120°. The meshing teeth 604 have a tooth height of 0.5mm, and the fastening nut 602 has an M24×1.5 trapezoidal thread. The adjustment range is 8-16mm, which is suitable for various endoscopes with diameters of 9.8-13.2mm. The repeatability accuracy is 0.1mm.

[0038] Example 1: Application of ESD under gastroscopy 1. Surgical Background and Clinical Needs Endoscopic submucosal dissection (ESD) is primarily used to treat early-stage gastric mucosal cancer, precancerous lesions, and large flat polyps, requiring complete dissection of the lesion tissue under the mucosa. In traditional procedures, the surgeon inserts a handheld Olympus GIF-H290 endoscope (9.8mm in diameter) through the mouth, observing the lesion (e.g., a 2.5cm × 3.0cm flat adenoma in the antrum) via a camera at the endoscope's tip, while simultaneously performing dissection using a high-frequency electrosurgical unit. Due to factors such as gastric peristalsis, patient breathing, and surgeon fatigue, the endoscope is prone to unintended displacement, leading to swaying of the field of vision, misalignment of the instrument channel, and increased risks of bleeding and perforation. Clinical data shows that under traditional handheld operation, the radial displacement of the endoscope during the procedure can reach 1.2-2.5mm, increasing the average surgery time by 15-20 minutes per procedure due to field adjustment.

[0039] 2. Fixation System Composition and Parameter Adaptation This embodiment uses an anti-displacement fixator for endoscopic surgery, with the following specific configuration: Fixed end module: Sleeve 601 is made of 304 stainless steel, with an inner diameter of 12mm (tolerance H8), a length of 80mm, and an inner wall finish of Ra0.8μm. It forms a clearance fit with the GIF-H290 gastroscope (diameter 9.8mm) (fitting tolerance H7 / g6) to ensure that the endoscope can slide axially along the central axis ±30mm, and the radial offset is controlled within 0.2mm. The endoscope fastening assembly includes 3 medical silicone elastic strips 603 (Shore hardness 60±5A, evenly distributed at 120°), and the end engagement teeth 604 are 0.5mm high. It is fitted with an M24×1.5 trapezoidal thread fastening nut 602, with an adjustment range of 8-16mm, suitable for gastroscopes with a diameter of 9.8mm, and the fastening force is continuously adjustable from 50-80N.

[0040] Flexible support system: Made of 2024 aluminum alloy, with a total weight of 480g and a load capacity of 2.5kg; Buckle 1 is a K-01 medical-grade plastic quick-release structure with an opening size of 35mm (compatible with the diameter of the operating table crossbar of 32mm), a clamping force of 65N, and can be installed / removed by pressing the release button, which takes 12 seconds; Sub-support 2 is 200mm long and is connected to the multi-axis adjuster through an M8 internal thread, with a coaxiality error of 0.08mm / m.

[0041] The multi-axis adjustment module consists of an X-axis adjuster 3 (horizontal rotation ±45°), a Y-axis adjuster 4 (pitch adjustment ±30°), and a Z-axis adjuster 5 (axial extension 50mm) connected in series. Each axis adopts a tie rod ball joint structure (ball joint 10 diameter 12mm, PTFE ball sleeve 9 mating clearance 0.08mm, movement resistance 2.0N·m); the three axes are connected by an M12×1.5 metric thread (engagement length 20mm, assembly torque 38N·m), with a locking washer to prevent loosening; the positioning pin 13 is an M6×16 hexagon socket head cap bolt, and the arc block 12 is made of 65Mn spring steel (hardness HRC42), with a locking contact pressure of 2.3MPa, an unlocking force of 25N, and a shaft wobble of 0.08mm after locking.

[0042] 3. Surgical Procedure 3.1 Preoperative preparation (15 minutes) The patient was placed in the left lateral decubitus position, and routine endotracheal intubation anesthesia was administered, with intravenous access established. The surgical team installed the fixation device according to the following steps: ① Attach the buckle 1 to the crossbar on the left side of the operating table (50cm from the patient's shoulder), press the locking button until a "click" sound is heard, and confirm that the clamping force is ≥150N; ② Connect the multi-axis adjuster through the auxiliary bracket 2, and tighten the threaded connections of the X-axis, Y-axis, and Z-axis adjusters in sequence (torque 38N·m), checking that there is no jamming in the range of motion of the three axes; ③ Install the sleeve 601 at the end of the Z-axis adjuster, insert the GIF-H290 gastroscope, adjust the initial diameter of the elastic strip 603 to 10mm, and pre-tighten the fastening nut 602 until the endoscope has no axial movement (no displacement when the tensile force test is 45N).

[0043] 3.2 Intraoperative application (65 minutes) Lesion localization stage: The doctor inserts the endoscope through the mouth into the antrum of the stomach. After locating the lesion, coarse adjustments are made using the multi-axis adjuster: the X-axis rotates 30° to align the endoscope with the lesion, the Y-axis tilts -15° to adjust the field of view, and the Z-axis extends 25mm to control the insertion depth. After confirming a clear field of view, the X-axis and Y-axis positioning pins 13 are tightened clockwise, and the arc-shaped block 12 is pressed against the ball head 10 to lock it in place. At this point, the radial offset of the endoscope is 0.15mm, and the stability of the field of view is improved by 90% compared to handheld operation.

[0044] Submucosal injection and marking stage: The endoscope needs to be fixed to free the doctor's hands to operate the injection needle. The operating nurse holds the endoscope with her left hand and rotates the fastening nut 602 1.5 turns to the left with her right hand. The elastic strip 603, through the interlocking teeth 604, holds the endoscope tightly (fastening force 65N), with a radial deformation of 0.08mm, ensuring no distortion of the endoscopic optical system. The doctor inserts the injection needle through the instrument channel and injects a mixture of indigo carmine and normal saline at four points along the edge of the lesion. The endoscope does not shift during the lifting of the lesion, and the marking accuracy reaches 0.5mm.

[0045] During the dissection and hemostasis phase: The golden blade is switched for submucosal dissection. The endoscopic angle needs to be adjusted three times during the procedure: ① When dissecting the upper edge of the lesion, the Y-axis positioning pin is released, and the pitch is adjusted to +10° before being relocked; ② When treating bleeding points, the Z-axis adjuster is shortened by 5mm to ensure the hemostat is precisely aligned with the bleeding point; ③ Before the dissection is completed, the X-axis is rotated -20° to observe the residual edge of the lesion. Each adjustment takes ≤15 seconds, saving 80% of the adjustment time compared to traditional handheld operation. The endoscope slides smoothly along the entire axis (resistance 4.5N) without any jamming.

[0046] 3.3 Postoperative care (10 minutes) After the procedure, the elastic strip 603 was loosened by turning the fastening nut 602 to the right, the endoscope was slowly withdrawn, and the fixator was removed by pressing the release button on buckle 1. After disinfection, it was ready for use. Postoperative pathology showed that the lesion was completely removed. The operation time was shortened by 18 minutes compared with the traditional method, the intraoperative blood loss was reduced by 30%, and no complications such as perforation occurred.

[0047] This embodiment achieves the following technological breakthroughs through the application of a fixator: ① Operational stability: Endoscope displacement ≤0.2mm, visual clarity improved to 98%, avoiding misoperation caused by shaking; ② Efficiency improvement: Average saving of 15-20 minutes per surgery, and the doctor's hand fatigue score reduced from 7.2 points (out of 10) to 3.5 points; ③ Compatibility: Through the adjustment of the elastic cylinder diameter, it can be adapted to mainstream gastroscopes such as Olympus GIF-H290 and Fuji EG-590WR (diameter 9.8-11.3mm); ④ Safety: Radial circumferential fixation avoids endoscope compression of the digestive tract wall, reducing the postoperative perforation rate from 2.3% to 0.5%.

[0048] Example 2: Application of ESD in Colonoscopy 1. Surgical Background and Clinical Needs Endoscopic submucosal dissection (ESD) is mainly used for the removal of large polyps (≥2cm in diameter) and laterally developing tumors (LST) in the colorectal region. It presents challenges due to the high curvature of the intestine, frequent intestinal peristalsis, and limited operating space. In traditional surgery, surgeons must hold the Olympus CF-H290AI colonoscope (13.2mm in diameter) with both hands, maintaining the field of vision by rotating the endoscope and adjusting knobs. Intestinal peristalsis often causes the endoscope to shift, requiring repeated repositioning. Clinical statistics show that the loss of field of vision due to displacement is as high as 35% in sigmoid colon surgeries, and an average of 25 minutes is spent on endoscope adjustments per procedure.

[0049] 2. Fixation System Composition and Parameter Adaptation The fixator configuration has been optimized as follows, taking into account the characteristics of colonoscopy: Fixed end module: Sleeve 601 inner diameter 14mm (tolerance H8), adapted to CF-H290AI colonoscope (diameter 13.2mm), axial sliding resistance ≤5N; elastic strip 603 diameter adjusted to 13.5mm, biting teeth 604 increased to 0.8mm (to prevent slippage due to intestinal fluid lubrication), fastening nut 602 preload adjusted to 80N to ensure no axial displacement of the endoscope during intestinal peristalsis.

[0050] Flexible support system: Clip 1 has an opening size of 45mm (fits the crossbar at the end of the operating table) and a clamping force of 80N; Sub-support 2 is 250mm long (increases the operating distance and avoids interfering with the doctor's standing position) and is made of carbon fiber reinforced material (reducing the weight to 380g, with a load capacity of 3kg).

[0051] Multi-axis adjustment module: The X-axis rotation range is extended to ±60° (to adapt to multiple angles of intestinal curvature), and the Z-axis extension stroke is increased to 80mm (to meet the needs of different patient body types); the ball head 10 is coated with titanium nitride (the coefficient of friction is reduced to 0.15), and the locking force of the positioning pin 13 is increased to 3MPa to meet the stability requirements of long-term surgery (≥2 hours).

[0052] 3. Surgical Procedure 3.1 Preoperative preparation (20 minutes) The patient is placed in the left lateral decubitus position for bowel preparation. Fixation steps: ① Attach clip 1 to the crossbar at the end of the operating table (60cm from the patient's anus), and adjust the clamping force to 75N using the spring-loaded locking mechanism; ② Assemble the multi-axis adjuster, setting the torque between the X and Y axes to 40N·m, and pre-adjusting the Z axis to the middle stroke (40mm); ③ Insert the CF-H290AI colonoscope, and after passing through sleeve 601, adjust the diameter of elastic strip 603 to 13.5mm, then tighten the fastening nut 602 until the endoscope does not move when the axial tension is ≥60N.

[0053] 3.2 Intraoperative application (90 minutes) Insertion and Positioning Stage: The physician inserts the colonoscope through the anus, sequentially traversing the rectum, sigmoid colon, descending colon, and hepatic flexure of the transverse colon, identifying a 3.0cm diameter LST lesion. Adjustment is achieved using a multi-axis adjuster: the X-axis rotates 45° to avoid the sigmoid colon bend, the Y-axis tilts -20° to align with the lesion, and the Z-axis extends / retracts 30mm to control the insertion depth. After locking the three-axis positioning pins, the radial offset of the endoscope is 0.12mm, and the field of view drift during intestinal peristalsis is ≤0.3mm (compared to 2.8mm drift with traditional handheld operation).

[0054] Submucosal dissection stage: Because the lesion is located in the transverse colon, the endoscopic angle needs to be adjusted multiple times: ① At the beginning of dissection, release the Y-axis positioning pin and tilt it +15° to make the electrocautery 45° angle with the mucosal surface; ② When dealing with blood vessels, extend the Z-axis by 15mm to increase the operating distance and rotate the X-axis -30° to expose the course of the blood vessels; ③ When dissecting to the edge of the lesion, simultaneously adjust the X-axis (+10°) and Y-axis (-5°) to achieve a "no blind spot" field of view. Each adjustment is completed by operating the positioning pin with one hand, taking an average of 12 seconds, saving 70% of the time compared to the traditional two-hand adjustment.

[0055] Specimen recovery and wound management: After dissection, loosen the fastening nut 602, retract the endoscope axially by 15mm, and remove the specimen (3.2cm in diameter) using a snare. Reinsert the endoscope, then fix it in place to observe the wound. Close examination was performed by shortening the Z-axis by 10mm, revealing two small bleeding points, which were precisely controlled with hemostatic forceps. Throughout the procedure, the endoscope did not shift, and the wound field of view remained stable.

[0056] 3.3 Postoperative care (15 minutes) The colonoscope was withdrawn and the fixation device was removed (taking 10 seconds), and the patient was safely returned to the ward. A follow-up colonoscopy 24 hours post-surgery showed good wound healing with no delayed bleeding. The total operation time was reduced by 22 minutes compared to the traditional method, and the physician's fatigue score decreased from 8.1 to 3.8.

[0057] 4. Analysis of Technological Advantages This embodiment, tailored to the characteristics of colonoscopy, demonstrates the following advantages: ① Anti-interference capability: Under strong intestinal peristalsis (frequency 3-5 times / minute), the endoscopic displacement is ≤0.3mm, and the stability of the field of view is improved by 85%; ② Operational flexibility: The multi-axis adjustment range is expanded to meet the needs of lesions in various parts of the colorectal region, especially suitable for surgery on curved areas such as the sigmoid colon and hepatic flexure; ③ Long-term stability: After a 2-hour continuous surgical test, the locking force of the positioning pin decreases by ≤5%, and the threaded connection remains secure; ④ Patient comfort: It reduces the surgeon's forceful rotation of the endoscope, and the postoperative abdominal pain score of patients decreases from 4.5 points (out of 10) to 2.1 points.

[0058] This endoscopic fixator, with its modular design, achieves a balance of precise fixation, flexible adjustment, and safety in gastroscopy and colonoscopy ESD procedures. In gastroscopy, it improves operational stability by 90% and reduces procedure time by 18 minutes; in colonoscopy, it significantly enhances resistance to intestinal peristalsis interference, reducing the field-of-view loss rate from 35% to 5%. Compatible with mainstream endoscope models and easy to operate, this fixator provides a reliable mechanical assistance solution for ESD procedures and has significant clinical application value.

[0059] The above description is merely a specific embodiment of the present invention, but the scope of protection of the present invention is not limited thereto. Any variations or substitutions that can be easily conceived by those skilled in the art within the technical scope disclosed in the present invention should be included within the scope of protection of the present invention. Therefore, the scope of protection of the present invention should be determined by the scope of the claims.

Claims

1. A shift-preventing fixator for endoscopic surgery for binding an endoscope (7) in a clinical procedure, the endoscope being a colonoscope or a gastroscope, characterized in that, The fixator comprises: a fixed end (6) which is detachably arranged on a clinic; The endoscope (7) is fitted on the fixed end (6) and keeps directional movement between the fixed end (6) and the clinic.

2. The shift-preventing fixator for endoscopic surgery according to claim 1, wherein The fixator further comprises: A flexible support arranged between the clinic and the fixed end (6) for providing a multi-degree of freedom adjustment space for the fixed end (6).

3. The shift-preventing fixator for endoscopic surgery according to claim 2, characterized by The flexible support comprises a buckle (1), a sub-support (2) and a multi-axis adjuster, the sub-support (2) is connected between the buckle (1) and the multi-axis adjuster, the buckle (1) is movably clamped on the clinic, and the fixed end (6) is arranged at the end of the multi-axis adjuster.

4. The shift-preventing fixator for endoscopic surgery according to claim 3, wherein The multi-axis adjuster comprises an X-axis adjuster (3), a Y-axis adjuster (4) and a Z-axis adjuster (5), and the three-axis connectors are sequentially connected head to tail.

5. The shift-preventing fixator for endoscopic surgery according to claim 4, wherein The X-axis adjuster (3), the Y-axis adjuster (4) and the Z-axis adjuster (5) are all pull rod ball head structures, which comprise a ball head (10) with a pull rod (11) and a ball sleeve (9) for binding the ball head (10), and the ball head (10) is limited to X-axis, Y-axis or Z-axis movement in the ball sleeve (9).

6. The shift-preventing fixator for endoscopic surgery according to claim 5, wherein The bottom of the ball sleeve (9) is provided with a threaded hole (8), and the end of the pull rod (11) is provided with an external thread matched with the threaded hole (8). The X-axis adjuster (3) and the Y-axis adjuster (4) and the Y-axis adjuster (4) and the Z-axis adjuster (5) are connected through the threaded structure between each other.

7. The shift preventing fixator for endoscopic surgery according to claim 5, wherein The ball sleeve (9) is further provided with a positioning pin (13), the end of the positioning pin (13) is provided with an arc block (12) which can move relative to the ball head (10), when it is necessary to observe and stay during the operation, the positioning pin (13) is tightened, the arc block (12) is tightly attached to the ball head (10) and the axis movement is fixed.

8. The shift preventing fixator for endoscopic surgery according to claim 2, wherein The fixed end (6) comprises a sleeve (601) fitted at the end of the flexible support, the endoscope (7) is fitted in the sleeve (601), and the endoscope (7) is limited in the sleeve (601) and moves along the central axis direction of the sleeve (601).

9. The shift-preventing fixator for endoscopic surgery according to claim 8, wherein The fixed end (6) further comprises an endoscope fastening assembly for fixing the endoscope (7) at the sleeve (601) through the endoscope fastening assembly when it is necessary to observe and stay during the operation.

10. The shift-preventing fixator for endoscopic surgery according to claim 9, wherein The endoscope fastening assembly includes an elastic strip (603) and a fastening nut (602). The elastic strip (603) consists of multiple strips arranged circumferentially on the left end face of the sleeve (601). The end of each elastic strip (603) is formed with a radially arranged interlocking tooth (604) and is closed to form an adjustable-diameter elastic cylinder. The endoscope (7) passes through the sleeve (601) and the elastic cylinder in sequence. The fastening nut (602) is fitted on the outer side of the elastic cylinder. When the fastening nut (602) is tightened to the left relative to the elastic cylinder, the endoscope (7) is clamped by the interlocking tooth (604) to achieve fixation. Conversely, the endoscope (7) is loosened to the right. When the endoscope (7) needs to be replaced, the diameter can be adjusted according to the type of endoscope (7) to be replaced.

Images