A double clamp that can be turned over under a digestive endoscope

CN122581858APending Publication Date: 2026-08-18PEKING UNIVERSITY THIRD HOSPITAL (THE THIRD CLINICAL MEDICAL SCHOOL OF PEKING UNIVERSITY) +1
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Patent Information

Application Number
CN202610613479.9
Authority / Receiving Office
CN · China
Patent Type
Applications(China)
Current Assignee / Owner
Filing Date
2026-05-07
Publication Date
2026-08-18

AI Technical Summary

Technical Problem

面对向管腔外翻转的高张力动态组织,这类传统器械难以顺应创面走向深入浆膜侧精准抓取外翻的创缘;即使勉强钳夹,也往往仅能实现黏膜层的表浅拉拢,无法提供足够的几何干预力来克服固有肌层张力以逆转组织的形态学走向

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Abstract

The present application relates to a kind of digestive endoscope under reversible double forceps. The double forceps include coaxial sleeve outer cannula and central fixed arm, and the central fixed arm is provided with sliding slot;Far end execution component includes the sliding pin of controlled translation across sliding slot and two groups of symmetrical grabbing unit.Long arm is pivoted to sliding pin, and short arm is pivoted to long arm and independently occlusion.When sliding pin is translated to proximal end, rely on the anchoring resistance of short arm occlusion tissue and / or the mechanical extrusion of outer cannula end, long arm is forced to close around sliding pin, realize the turning of everted wound edge and overlapping apposition.In addition, transmission wire is hiddenly arranged in the inner cavity of long arm after winding on the surface of sliding pin, which physically avoids the interference of translation space;When separated and released, the distal end of outer cannula stays in the body to form radial constraint, completely lock the rotation degree of freedom of long arm.The present application effectively realizes the safe, full layer and long-term stable closure of complex perforation of digestive tract.
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Description

Technical Field

[0001] This invention relates to the field of medical device technology, and in particular to a reversible double clamp for digestive endoscopy. Background Technology

[0002] With the rapid development of minimally invasive digestive endoscopy techniques, advanced endoscopic minimally invasive surgeries such as endoscopic full-thickness resection (EFTR) are increasingly widely used in clinical practice. During the resection of deep and complex lesions in the digestive tract, large perforations or full-thickness defects in the digestive tract wall are often unavoidable. Achieving safe and reliable closure of such large perforated wounds, especially ensuring full-thickness closure of the serosal layer to the serosal layer, is a crucial step in ensuring surgical success and preventing serious postoperative complications such as gastrointestinal fistulas and abdominal infections.

[0003] However, the physiological structure and mechanical properties of the digestive tract wall determine that the wound morphology is often extremely complex when large-area perforation occurs. Due to the inherent tensile retraction of the muscular and serosa layers of the digestive tract wall, coupled with the significant increase in intraoperative pressure caused by endoscopic insufflation to maintain the field of vision, the perforation edges typically exhibit an outward-turned shape, deviating from the central axis of the lumen. This outward-turned wound not only involves uneven tissue thickness and localized high tension, but also completely exposes the normally tightly closed serosa layer outside the lumen, deviating from the conventional operating axis of the endoscopic instruments, greatly increasing the difficulty of endoscopic suturing.

[0004] Currently, most commonly used endoscopic closure instruments in clinical practice (such as traditional soft tissue clips, three-arm metal clips, or OTSC clips) are designed based on a single clamping logic of "pulling from the mucosal plane." The gripping direction of their clamping arms is usually limited to a straight downward direction or a simple single-layer planar opening and closing state. When faced with high-tension dynamic tissue that is everted outward, these traditional instruments struggle to accurately grasp the everted wound edge by reaching deep into the serosal side, following the wound's direction. Even if they manage to clamp, they often only achieve superficial traction of the mucosal layer and cannot provide sufficient geometric intervention force to overcome intrinsic muscle layer tension and reverse the tissue's morphological orientation. Furthermore, most existing clamping instruments use the same power source for coarse synchronous control of each operating arm, lacking independent multi-degree-of-freedom operation. In the confined and curved space of an endoscopic surgery, it is difficult to implement stable and adaptive multi-point grasping for wound edges with uneven thickness. Forced traction can easily lead to physical tearing or mechanical slippage of the diseased tissue. Therefore, existing closure instruments cannot effectively force the everted wound edges to be flipped back into the cavity and achieve precise full-thickness overlapping and alignment, resulting in low closure efficiency and poor alignment quality for complex wounds, making it difficult to meet the urgent need for stable full-thickness closure of large-area perforations in modern digestive endoscopic surgery.

[0005] Furthermore, on the one hand, there are differences in understanding among those skilled in the art; on the other hand, the applicant studied a large number of documents and patents when making this invention, but due to space limitations, not all details and contents were listed in detail. However, this does not mean that the present invention does not possess the features of these prior art. On the contrary, the present invention already possesses all the features of the prior art, and the applicant reserves the right to add relevant prior art to the background art. Summary of the Invention

[0006] In view of the shortcomings of the prior art, the present invention provides a reversible double clamp for digestive endoscopy to solve at least some of the above-mentioned technical problems.

[0007] In a first aspect, the present invention discloses a reversible dual clamp for gastrointestinal endoscopy, comprising: a guide sleeve coaxially sleeved on the outermost layer, and a central fixing arm passing through the guide sleeve, the central fixing arm having a groove defined along its central axis; a distal actuation assembly, comprising a sliding pin laterally passing through the groove and subject to controlled translation, and two sets of unilateral gripping units symmetrically distributed with respect to the central fixing arm; each set of unilateral gripping units includes a long arm constituting a first-level hinge and a short arm constituting a second-level hinge. The proximal ends of the first long arm and the second long arm are coaxially pivotally connected to the outer circumferential surface of the sliding pin; the first short arm is pivotally connected to the distal end of the first long arm, and the second short arm is pivotally connected to the distal end of the second long arm, and the short arm is controlled to perform an engagement action independently of the corresponding long arm; wherein, when the sliding pin is axially translated proximally, the first long arm and the second long arm can perform a radial closing action around the sliding pin by relying on the distal anchoring resistance formed after the short arm engagement tissue, and / or relying on the relative mechanical abutment between the distal end of the outer sleeve and the inclined outer side wall of the long arm.

[0008] Existing single-hinged instruments typically lack mechanical intervention to reverse tissue morphology when dealing with everted wound edges, making it difficult to achieve effective apposition of the serous layers. To address this, the distal actuation component of this application constructs a variable-direction linkage system based on a central fixed arm, a sliding pin, and two-stage articulated long and short arms. After the short arm penetrates the wound edge, the sliding pin's translational movement along the sliding groove towards the proximal end directly triggers a dual intervention of biological and mechanical forces: on the one hand, the tissue's own reverse traction tension forms anchoring support at the distal end; on the other hand, the distal end of the relatively forward-extending guide sleeve directly contacts and compresses the outer wall of the long arm. This intervention of distal resistance or external compression breaks the simple axial backward movement freedom, thereby transforming the axial tensile rigidity into a radial deflection torque that drives both long arms towards the central axis. This transmission logic forcibly flips the everted wound tissue from the physical force boundary, providing the necessary structural support for the apposition of the serous layers on both sides.

[0009] According to a preferred embodiment, a one-way check mechanism is provided at the pivot joint between the first short arm and the first long arm, and at the pivot joint between the second short arm and the second long arm. The one-way check mechanism is configured to allow the corresponding short arm to perform a closing action and rigidly lock its reverse opening degree of freedom within a preset safe range of digestive tract tissue tension. An overload release structure is provided at the limiting transition of the one-way check mechanism. When a reverse operating force exceeding a preset threshold is applied to the short arm through the proximal end, the one-way check mechanism undergoes overload retraction to release the check state, allowing the short arm to reopen for repositioning.

[0010] Considering that limited endoscopic field of view often leads to deviations in the initial clamping position, if the closure mechanism lacks release capability, it is highly susceptible to causing physical tearing of tissue due to forced pulling. This design incorporates a one-way check mechanism with an overload release structure at the pivot point of the long and short arms. Under normal gastrointestinal tissue retraction tension, this mechanism maintains rigid check, locking the short arm in its grasping state. When repositioning is necessary, the operator can apply a reverse thrust exceeding the normal tension threshold, forcing the check mechanism to undergo overload yielding deformation and release the lock. This design, based on mechanical thresholds to differentiate working states, maintains static clamping stability while meeting the operational requirements for reversible opening and closing and safe repositioning of instruments during clinical surgery.

[0011] According to a preferred embodiment, the one-way check mechanism includes a shaft base shell, a coil spring sleeved on the short arm shaft, and an elastic pawl integrally formed on the side wall of the shaft; the inner annular surface of the shaft base shell is defined by a toothed groove; when the reverse rotation tendency is generated by tissue tension, the end face of the elastic pawl abuts against the limiting surface of the groove; the overload release structure is an overload release chamfer provided at the top of the limiting surface.

[0012] As a specific structural implementation of the one-way check mechanism, this invention employs a mechanical pair combination of a rotating shaft base shell, a coil spring, and an elastic pawl. The bias torque provided by the coil spring, combined with the sliding of the pawl and the toothed groove, allows the short arm to close smoothly. When subjected to a reverse torque, the pawl abuts against the limiting surface to form hydrostatic interference to prevent retraction. Simultaneously, the overload release chamfer at the top of the limiting surface alters the friction angle and force direction of the contact interface, allowing the reverse thrust exceeding the threshold to be converted into a normal component force that forces the pawl to bend radially. This configuration utilizes the constraint and release boundaries of geometric surface features to achieve a smooth transition between self-locking and overload unlocking within a small shaft-shell gap.

[0013] According to a preferred embodiment, multiple anti-slip hook teeth are continuously arranged along the axis on the inner working surfaces of the first long arm and the first short arm facing each other, and on the inner working surfaces of the second long arm and the second short arm facing each other; in the initial state without external traction, the far end of each short arm is offset outward relative to the inner side of the corresponding long arm to define an initial V-shaped capture window on both sides.

[0014] To overcome the defect that uneven wound edges or high-tension wound edges easily slip off the working surface of the grippers when subjected to mechanical traction, the single-sided gripping unit of this application has an outwardly offset open configuration in the initial state, thereby obtaining a deeper tissue-accommodating area in the initial contact stage. Combined with the continuous hook teeth arranged on the inner working surface of the long and short arms, the short arm can penetrate deep into the tissue at a specific angle when closed. This arrangement of microstructures transforms simple frictional surface clamping into multi-point physical obstruction in the normal and tangential directions, effectively resisting the escape stress generated by the tissue during subsequent flipping operations.

[0015] According to a preferred embodiment, the dual clamps further include an operation control assembly distributed on the proximal control surface, which includes a wire traction member for controlling the engagement of the short arm and a sliding pin traction member for controlling the translation of the sliding pin. The wire traction component is equipped with a mechanical linkage lock that cooperates with the sliding pin traction component. The mechanical linkage lock is configured to lock the wire traction component and the sliding pin traction component together axially when closed, so that when the sliding pin is pulled towards the proximal end, the cable controlling the short arm engagement can be pulled synchronously and at equal intervals to compensate for displacement difference and maintain gripping force.

[0016] Secondly, this invention discloses a reversible dual clamp for digestive endoscopy, comprising a central fixing arm, a sliding pin that is controlled to translate within the central fixing arm, and a long and short arm grasping assembly pivotally connected to the sliding pin. Internally, a concealed transmission system is constructed to avoid spatial strangulation interference: the first and second long arms of the long and short arm grasping assembly each have a hollow cable routing cavity defined axially; a first steel wire and a second steel wire, used to independently control the biting action of the short arm, pass through the central fixing arm and wrap around the cylindrical surface of the sliding pin at least once, then extend distally into the hollow cable routing cavities of the first and second long arms respectively; this converts the translational interference experienced by the cable into a wrap angle following the surface of the sliding pin, physically avoiding the axial translational trajectory of the sliding pin.

[0017] Multi-degree-of-freedom endoscopic instruments are prone to spatial interference of cables within their confined internal lumens. The concealed transmission system of this invention reconstructs the cable transmission path spatially by creating a hollow cable routing cavity inside the long arm and inserting the control wire through this cavity after it winds around the surface of the sliding pin. This structure allows the wire to translate synchronously with the sliding pin, transforming the cable's original transverse trajectory into a localized wrap-around state around the joint axis. By completely avoiding the spatial sweep area during mechanism translation, the risk of compression and shearing of the transmission cable by the reciprocating motion of the sliding pin is physically eliminated, ensuring the mechanical reliability of the core linkage mechanism.

[0018] According to a preferred embodiment, the distal end of the first steel wire passes through the first long arm and is eccentrically connected to the outer peripheral edge of the first short arm pivot; the distal end of the second steel wire passes through the second long arm and is eccentrically connected to the outer peripheral edge of the second short arm pivot; so as to convert the axial tension into a driving torque that overcomes the elastic preload and rotates around the axis of the short arm pivot.

[0019] To improve the force output performance of the short arm in confined spaces, this embodiment eccentrically anchors the distal end of the steel wire exiting the long arm's cable routing cavity to the outer periphery of the short arm's pivot. This eccentric connection artificially constructs a cantilevered arm offset from the geometric center of rotation of the pivot. Based on the principle of lever mechanics, this allows the linear tension input axially at the operating end to be converted into a rotational driving torque acting on the short arm. This torque conversion structure effectively overcomes the preload of the internal elastic element and external resistance, ensuring the strength of the short arm's engagement action.

[0020] Thirdly, this invention discloses a reversible dual clamp for gastrointestinal endoscopy, comprising a central fixation arm, a long and short arm grasping assembly, and an outer sleeve coaxially fitted around the periphery of the central fixation arm. It includes a synchronous separation mechanism based on radial constraint release to convert the closed distal assembly into an implant: the central fixation arm is divided into a proximal segment and a distal segment on a specific axial plane; the proximal end of the proximal segment of the central fixation arm has a first flexible mating end, and the distal end of the distal segment of the central fixation arm has a second flexible mating end with a complementary shape; the outer sleeve has a pre-set separation fracture along the axial direction to divide the outer sleeve into a proximal withdrawal segment and a distal retention segment. In the unseparated state, the rigid inner wall of the distal stationary section of the outer sleeve covers the periphery of the engagement area, providing a constraint boundary to limit the radial expansion of the second flexible mating end. In the separated state, the rear section of the central fixing arm retracts proximally, allowing the second flexible mating end to move relatively out of the outer sleeve's coverage area and gain space for outward expansion and retraction, thereby relieving axial mechanical interference and releasing the front section of the central fixing arm. Simultaneously, the outer sleeve physically decouples at the preset separation fracture point, with its proximal retraction section retracting proximally, and the distal stationary section of the outer sleeve remaining inside the body, thereby locking the rotational degrees of freedom of the long and short arm gripping components through external radial limiting and maintaining a closed state.

[0021] In existing split-type clamps, the long arm often becomes loose due to the loss of radial constraint after the external delivery tool is removed, leading to closure failure. The synchronous separation mechanism of this invention, while disconnecting the distal component, simultaneously sets the outer sleeve to disconnect along the separation fracture, transforming its distal covering section into part of the implant. After the engagement area of ​​the central fixation arm moves out of the covering range and the tubing is released, the remaining distal section of the outer sleeve remains around the base of the long and short arm components. This residual tube forms a closed-loop rigid boundary, directly interfering with and locking the long arm's degree of freedom to rotate around the sliding pin from a physical geometry perspective. The external rigid constraint counteracts the continuous outward tension of the tissue, maintaining a long-term overlapping posture.

[0022] According to a preferred embodiment, the multiple transmission cables passing through the central fixed arm are all cut into a distal dwelling section and a proximal traction section within approximately the same axial range; each cable has a plug fixed at the end of the distal dwelling section and a flexible plug fixed at the end of the proximal traction section; the flexible plug can simultaneously undergo radial retraction deformation to release the plug when it moves out of the coverage area of ​​the outer sleeve.

[0023] If a forcibly broken metal cable remains in the implant, its sharp end poses a high risk of puncture injury during gastrointestinal peristalsis. This application utilizes the shape matching of the connector and the flexible connector as the cable release interface. After losing the constraint boundary of the outer sheath, the flexible connector radially expands and releases the distal cable inside. After separation, the connector fixed at the end of the distal retention segment not only serves as an initial stress-bearing node, but its locally enlarged outer diameter also acts as a passivating cap, completely covering the internal metal load-bearing section, preventing contact between the sharp-angled end face and the surrounding tube wall mucosa, and reducing the risk of mechanical puncture injury during device placement.

[0024] According to a preferred embodiment, the dual clamps further include a single-point synchronous release component disposed on the proximal control surface; the proximal traction sections of the multiple transmission cables are uniformly mounted on the single-point synchronous release component so as to apply a uniform parallel axial retraction force to each internal transmission cable when triggered, forcing the multiple cables and the joint area of ​​the central fixed arm to break through mechanical interference and complete physical release at the same instant, thereby eliminating the asymmetrical off-center load torque.

[0025] During endoscopic surgery, the distributed friction force on the transmission cables varies significantly due to the bends in the digestive tract. Asynchronous cable tripping can easily induce off-center torque at the distal end, causing clamp bounce. By introducing a single-point synchronous release component at the proximal end and uniformly attaching each traction segment, this solution integrates multiple independent tensile force inputs into a collinear parallel load. This centralized pull-out path ensures that all cables have an absolutely consistent force sequence when breaking through the distal mechanical interference interface, eliminating the uneven tensile force caused by step-by-step tripping and ensuring the force balance and positional stability of the distal implanted component at the moment of physical decoupling.

[0026] According to a preferred embodiment, the proximal end of the slide groove of the central fixed arm is defined with a locking groove that is laterally enlarged; a flexible locking wing is fixed at the bottom of the sliding pin; when the sliding pin moves into the locking groove, the flexible locking wing expands radially and forms axial interference with the locking groove to block the sliding pin's retraction path to the distal end.

[0027] Because the lateral surface of the slide pin exhibits a continuous retraction force, it can easily cause the sliding pin at the actuator end to slide backwards. This solution utilizes the locking groove at the near end of the slide channel and the flexible locking wing at the bottom of the slide pin to form an anti-retraction structure. When the slide pin moves to its limit working position, the locking wing expands radially due to the loss of sidewall compression, and its end face immediately forms a structural interference in an orthogonal direction with the locking groove. This arrangement directly converts the axial tensile load into a normal compressive force between the two rigid body end faces, blocking the slide pin's reverse sliding path along the slide channel and achieving mechanical position locking at the end of the clamp's closed stroke. Attached Figure Description

[0028] Figure 1 This is a schematic diagram of the overall structure of the reversible double clamp under digestive endoscopy provided by the present invention in the folded state; Figure 2 This is a schematic diagram of the overall structure of the reversible double clamp under digestive endoscopy provided by the present invention in the open state; Figure 3 This is a partially enlarged schematic diagram of the remote execution layer (long and short arm assembly and slide pin structure) provided by the present invention in the open state; Figure 4 This is a schematic diagram of tissue intervention in state one (target approach and work span establishment stage) in the surgical workflow of the present invention; Figure 5 This is a schematic diagram of tissue intervention in state two (independent double-point insertion and eversion solidification stage) in the surgical workflow of the present invention; Figure 6 This is a schematic diagram of tissue intervention in state three (dynamic traction and forced flipping intervention stage) in the surgical workflow of the present invention; Figure 7 This is a schematic diagram of tissue intervention in state four (terminal alignment and mechanical compression surface formation stage) in the surgical workflow of the present invention; Figure 8 This is a schematic diagram of tissue intervention in state five (physical boundary decoupling and implant residence stage) in the surgical workflow of the present invention; Figure 9 This is a schematic diagram of the internal cross-sectional structure of the traction pipeline basic routing and separation release mechanism provided by the present invention; Figure 10This is a partial enlarged cross-sectional view of the separation and release mechanism provided by the present invention under radial constraint and locking (non-separated state) of the outer sleeve; Figure 11 This is a partial enlarged cross-sectional view of the separation and release mechanism provided by the present invention in the state of releasing radial constraints and completing mechanical interference surface decoupling (separation and release state); Figure 12 This is a schematic diagram of the structure of the remote transmission cable (first steel wire, second steel wire and sliding pin steel cable) provided by the present invention connected and assembled with an independent mechanical support point; Figure 13 This is a schematic diagram of the action state transition of the macroscopic flip stroke anti-retraction positioning mechanism (sliding pin self-locking) provided by the present invention; Figure 14 This is a partial internal cross-sectional view of the unilateral tissue micro-grasping force maintenance mechanism (rotating shaft and elastic pawl unidirectional check) provided by the present invention.

[0029] List of reference numerals 110: Outer tube; 120: Tube pulling component; 130: Outer tube steel cable; 200: Central fixing arm; 210: Front section of central fixing arm; 220: Rear section of central fixing arm; 230: First flexible mating end; 240: Second flexible mating end; 250: Slide groove; 260: Snap-fit ​​groove; 310: First long arm; 320: First short arm; 330: First short arm pivot; 340: Second long arm; 350: Second short arm; 360: Second short arm Arm pivot; 370: Hook tooth; 410: Sliding pin; 420: Flexible snap-fit ​​wing; 510: First steel wire; 511: First steel wire traction component; 520: Second steel wire; 521: Second steel wire traction component; 530: Sliding pin cable; 531: Sliding pin traction component; 540: Plug connector; 550: Plug connector seat; 600: Pivot base; 610: Coil spring; 620: Elastic pawl; 630: Groove; 710: First structure; 720: Second structure. Detailed Implementation

[0030] The following is a detailed explanation with reference to the accompanying drawings.

[0031] like Figure 1 and Figure 2 As shown, this embodiment provides a reversible double clamp for gastrointestinal endoscopy. This embodiment is designed based on the scenario of traction closure of a full-thickness perforation of the digestive tract and eversion of the wound edges under endoscopic guidance. The overall outer diameter of the instrument is adapted to the additional clamp channels of the endoscope (e.g., standard clamp channels with an aperture ≥ 2.8 mm), facilitating delivery through the digestive tract and extension into the serosal cavity for surgical procedures. This instrument is preferably packaged in disposable aseptic packaging to meet clinical infection control requirements.

[0032] To ensure accurate reproduction of the relationship between the internal multi-level transmission and the external structure, this embodiment uses the geometric center axis of the central fixed arm 200 as the reference datum for core assembly and measurement. The axial, radial, and circumferential directions are defined with reference to this central axis, where the axial direction is parallel to the central axis, the radial direction is perpendicular to the central axis and points outwards, and the circumferential direction extends along the outer periphery. Simultaneously, along the extension direction of the central axis, the side closer to the external operator is defined as the proximal region, and the side with the clamping member is defined as the distal region.

[0033] In terms of overall architecture design, the endoscopic flip-type dual clamp includes a central fixation arm 200 and a flip-type movable component that cooperates with the central fixation arm 200. The system is divided into four functional levels from the outside to the inside and from the near to the far, namely the external guidance level, the core support level, the proximal input level, and the remote execution level.

[0034] The outer guide layer includes an outer sheath 110 and a sheath puller 120. The outer sheath 110 extends axially and is substantially coaxial with the central fixation arm 200, surrounding the main body of the central fixation arm 200 to form an external covering and isolation boundary. As an external guide component, it cooperates with the central fixation arm 200 to form a spatially relatively fixed whole. The sheath puller 120 is fixedly disposed on the proximal outer wall of the outer sheath 110. The materials of the outer sheath 110 and the sheath puller 120 can be selected from medical engineering plastics or metals to balance flexibility during bending within the digestive tract with axial thrust support rigidity.

[0035] The core support layer is mainly composed of the central fixed arm 200. The central fixed arm 200 passes through the inner hole of the outer sleeve 110, with its distal end extending out of the distal end face of the outer sleeve 110 and its proximal end extending backward beyond the sleeve traction member 120, providing the entire device with a rigid load-bearing skeleton that runs through the proximal and distal ends, as well as a sliding guide rail.

[0036] The proximal input layer comprises an externally distributed operation control assembly consisting of a first wire traction member 511, a second wire traction member 521, and a sliding pin traction member 531. The sliding pin traction member 531 is positioned near the very proximal end of the central fixed arm 200. Two symmetrical lateral branch tubes extend from the axial section between the sleeve traction member 120 and the sliding pin traction member 531. The first wire traction member 511 and the second wire traction member 521 are radially outwardly offset relative to the central axis and are respectively mounted at the ends of the two lateral branch tubes. Their extension directions form an acute angle with the central axis, creating a tree-like spatial divergence structure. Thus, the sleeve traction member 120, the first wire traction member 511, the second wire traction member 521, and the sliding pin traction member 531 together construct a multi-channel fixed-position control surface at the proximal end, with each operation path spatially independent. Furthermore, to prevent the first short arm 320 and the second short arm 350 from losing synchronization and cable slack due to the rearward shift of the distal fulcrum when pulling the sliding pin 410 towards the proximal end, the first wire traction member 511 and the second wire traction member 521 are equipped with mechanical linkage latches that cooperate with the sliding pin traction member 531. After the short arm completes its independent engagement action, the operator can close the mechanical linkage latches, making the first wire traction member 511, the second wire traction member 521, and the sliding pin traction member 531 rigidly locked together axially. Subsequently, when the sliding pin traction member 531 is pulled towards the proximal end to perform the closing action, the first wire 510 and the second wire 520 will be pulled backward synchronously and at equal intervals, thereby accurately compensating for the spatial displacement difference caused by the short arm retracting with the long arm, ensuring that the adaptive gripping force of the short arm remains constant and not lost during dynamic flipping.

[0037] like Figure 3 As shown, the distal execution layer is integrated on the distal cantilever section of the central fixation arm 200 extending beyond the outer sleeve 110, and includes a first long arm 310, a first short arm 320, a second long arm 340, a second short arm 350, a sliding pin 410, and a sliding groove 250 formed on the central fixation arm 200. The single-sided gripping unit formed by the first long arm 310 and the first short arm 320, and the single-sided gripping unit formed by the second long arm 340 and the second short arm 350, are distributed in a mirror-symmetrical manner with reference to the central longitudinal section of the central fixation arm 200. The materials of the first long arm 310, the first short arm 320, the second long arm 340, and the second short arm 350 can be selected from medical stainless steel, cobalt-chromium alloy, or nickel-titanium alloy to ensure that the grippers have the bending strength to penetrate the mucosa or serous membrane surface and the fatigue resistance under small dimensions.

[0038] Combination Figure 1 and Figure 2Comparing the external contours, the distal execution level can switch between a retracted state and an open state. In the retracted state, the first long arm 310 and the second long arm 340 are folded and closed relative to the central axis, and the overall maximum radial dimension of the distal execution level is limited within a cylindrical envelope that matches the outer diameter of the outer sleeve 110. Its distal shape is a linear cylinder to meet the axial sliding conditions within the narrow forceps channel of the endoscope. In the open state, the first long arm 310 and the second long arm 340 expand radially to both sides relative to the central fixation arm 200, breaking through the initial cylindrical envelope constraint. The distal shape abruptly changes into an anchor-shaped or umbrella-shaped structure, thereby forming a grasping span sufficient to cover the perforated wound on the serous cavity side.

[0039] In terms of the specific construction of the core actuator, the remote execution level is presented as a linkage mechanism that achieves grasping through multi-stage hinges. The remote solid segment of the central fixed arm 200 is defined along the central axis to form an elongated guide cavity with a radial thickness extending through it, thus defining the slide groove 250. The sliding pin 410 has a cylindrical pin structure and is transversely inserted into the slide groove 250. Based on the limiting constraint of the inner straight wall of the slide groove 250, the relative movement of the sliding pin 410 under the constraint of the guide structure is restricted to reciprocating translation along the central axis, and the side wall structure of the slide groove 250 restricts the radial and circumferential offset of the sliding pin 410.

[0040] The first long arm 310 and the second long arm 340 form the main bearing base for clamping operations. Their proximal bases are stacked or arranged side-by-side and coaxially fitted onto the outer circumferential surface of the sliding pin 410 via a clearance fit. This first-level hinged connection allows the sliding pin 410 to serve as a shared pivot point for all three, enabling the first long arm 310 and the second long arm 340 to not only follow the sliding pin 410 in axially restricted translation along the central fixed arm 200, but also to each gain independent degrees of freedom to rotate about the axis of the sliding pin 410 in the radial plane, using the outer cylindrical surface of the sliding pin 410 as a rotation reference. Thus, the first long arm 310 and the second long arm 340 can simultaneously perform opening or closing movements around the cylindrical axis of the sliding pin 410 while moving axially with it. This superposition of two levels of motion allows for adjustment of the spatial working position and gripping angle at the execution end.

[0041] To address the complex morphology and uneven tissue thickness of perforations under endoscopy, an independent secondary gripping module is further hinged to the distal end of the long arm. A first short arm pivot 330 is mounted on the offset section at the distal end of the first long arm 310, and the middle of the first short arm 320 is pivotally connected to this first short arm pivot 330. Similarly, a second short arm pivot 360 is mounted on the distal end of the second long arm 340, and the second short arm 350 is pivotally connected to this second short arm pivot 360. Thus, the first short arm 320 and the first long arm 310 together constitute the first set of two-point gripping units, and the second short arm 350 and the second long arm 340 constitute a mirror-symmetrical second set of two-point gripping units. Based on this multi-stage hinged linkage arrangement, the local rotation of the short arm around its corresponding pivot and the macroscopic movement of the long arm around the sliding pin 410 do not interfere with each other spatially, allowing both short arms to independently perform engagement actions in any open posture of the long arm.

[0042] Taking a single-sided structure as an example, the first short arm 320 is physically divided by the first short arm pivot 330 into a gripping execution section located at the distal end of the pivot and a power input section located at the proximal end of the pivot, forming a lever cantilever that responds to force. When the power input section is stretched, the tension is amplified through this lever structure, causing the tip of the first short arm 320 to generate an adaptive gripping force of approximately 1.5~2N. Determining this gripping force range can improve the instrument's gripping stability on uneven tissues without tearing the tissue.

[0043] In the design of the micro-grasping interface, multiple hook teeth 370 are continuously arranged along the axis on the inner working surfaces of the first long arm 310 and the first short arm 320 facing each other, as well as on the inner working surfaces of the second long arm 340 and the second short arm 350 facing each other. To overcome the difficulty of aligning everted wound edges, in the initial state without external traction, the distal ends of the first short arm 320 and the second short arm 350 are offset outward relative to the inner surfaces of the long arms. This design, which changes the initial orientation, allows the instrument to conform to the shape of the everted wound edge and define an initial V-shaped capture window for capturing tissue on one side of the serous cavity.

[0044] Furthermore, the tooth surface of the hook 370 has an asymmetrical serrated structure, with its tooth tip and inclined surface uniformly tilted towards the proximal end where the sliding pin 410 is located. This morphology creates a unidirectional force constraint after penetrating the tissue: when the tissue is pulled inward and pulled into the cavity, its sliding resistance is low; however, when the tissue is under tension and tends to escape and slip out distally, the normal force of the inclined tooth surface in contact with the tissue increases sharply, forming a rigid mechanical barrier boundary to reduce the possibility of tissue slippage and ensure the reliability of subsequent closure operations.

[0045] To ensure that the tissue does not spring back or slip under high tension after being flipped and gathered, the actuator is equipped with a two-stage rigid self-locking system for rotational and translational degrees of freedom.

[0046] Regarding the microscopic maintenance mechanism of unilateral tissue gripping force, combined with Figure 14 The cross-sectional view shown indicates that the first short arm pivot 330 and the pivot base housing 600 form a mechanical interface with a one-way check valve function. A coil spring 610 is coaxially sleeved on the outer circumferential surface of the first short arm pivot 330. Under normal conditions without external force intervention, the first short arm pivot 330 is biased towards the open position under the initial retraction torque provided by the coil spring 610. The inner annular surface of the pivot base housing 600 is circumferentially defined by grooves 630 defined by continuously undulating teeth. Each groove 630 includes a gentle slope with a guiding function and a steep straight surface with a blocking function in cross-section.

[0047] Correspondingly, an integrally formed elastic pawl 620 extends from the top sidewall of the first short arm pivot 330. This elastic pawl 620 has a cantilever beam structure, with its end intersecting the movement trajectory of the groove 630. When the power source overcomes the preload of the coil spring 610 and drives the first short arm pivot 330 to perform a gripping rotation, the elastic pawl 620 elastically retracts along the gentle slope of the groove 630 and slides over the tooth back. Once the external force stops or tissue tension attempts to forcibly pull open the jaws, this structure forms a self-locking condition after assembly: the end face of the elastic pawl 620 abuts against the limiting surface of the groove 630. To balance anti-loosening and clinical repositioning requirements, the angle of the limiting surface and the bending section modulus of the pawl are precisely calibrated. When subjected to normal digestive tract tissue retraction tension (typically less than 3N), the normal force of the contact surface increases to suppress reverse rotational displacement, with the static pressure borne by the pivot base shell 600. Through the physical restraint of this structure, even after the steel wire loosens, the instrument can still maintain an adaptive gripping force of 1.5~2N, and the ratchet fixation function improves the gripping stability of tissues with uneven thickness. When repositioning is required, the operator applies a rigid thrust to the first steel wire 510 or the second steel wire 520 through the proximal manipulator. To prevent the slender cable from buckling under pressure in the curved channel of the endoscope, which would cause the thrust to fail, the first steel wire 510 and the second steel wire 520 preferably adopt a composite push-pull cable structure with compressive stiffness (e.g., the core wire is tightly wrapped with a high-stiffness stainless steel spring tube), thereby ensuring that the proximal thrust can be transmitted to the distal end without loss. The rotational torque generated by this thrust (e.g., converted into an equivalent tensile force greater than 5N) will exceed the calibrated threshold, forcing the elastic pawl 620 to bend and retract significantly along the overload release chamfer at the top of the groove 630, sliding into the next tooth groove or returning to the initial position, thereby releasing the unidirectional mechanical interference and allowing the short arm to reopen.

[0048] Regarding the anti-drawback positioning mechanism for macro-level reversal, combined with Figure 12 and Figure 13The sliding pin 410 serves as the core carrier for the overall translation of the actuator, and its bottom is fixed with a flexible locking wing 420. In its natural state, the flexible locking wing 420 presents a dovetail-shaped or barbed forked configuration that diverges obliquely towards the proximal end and radially outward. The groove 250 on the central fixed arm defines a limiting boundary of a constant first width within the axial main guide section. Near the proximal end of the operation, the groove 250 widens to both sides in a stepped manner at right angles or nearly right angles, defining a locking groove 260 of a second width, and the lateral dimension of this locking groove 260 is significantly larger than the first width of the groove 250.

[0049] As the sliding pin 410 slides proximally along the groove 250, the flexible locking wing 420 is compressed by the parallel sidewall of the groove 250 and is in a contracted state accumulating elastic energy. When the sliding pin 410 carries the flexible locking wing 420 into the axial section of the locking groove 260, due to the release of radial geometric constraints, the flexible locking wing 420 instantaneously releases potential energy and expands radially to both sides. At this time, the mating structure forms a unidirectional thrust limiting surface: the rearward end face of the flexible locking wing 420 and the stepped end face of the locking groove 260 form an axial orthogonal face. If the overturned tissue tends to retract distally, the expanded flexible locking wing 420 will directly abut against the stepped end face of the locking groove 260, using pure axial mechanical interference of the end face to physically block the retraction path of the sliding pin 410, achieving rigid locking of the overlapping shape of the perforated wound edge.

[0050] To ensure independent control of multiple degrees of freedom within a limited clamping space, the device is equipped with a spatially isolated long-distance transmission and traction pipeline layout system.

[0051] Based on the basic routing and guidance architecture of the pipeline, combined with Figure 9 and Figure 11The internal cross-sectional view shows that the central fixed arm 200 has a hollow guide cavity extending through the entire axis. The first steel wire 510, the second steel wire 520, the sliding pin cable 530, and the outer tube cable 130 are all threaded through this guide cavity. This embodiment uses the cavity's passability as a design baseline. By optimizing the radial coordinates of each group of cables on the guide cavity cross-section, the four groups of cables are arranged in a parallel array and occupy different radial positions (e.g., arranged in a triangular pattern), maintaining independent physical clearance. Based on the radial constraint of the guide cavity's inner wall, the relative displacement of each group of cables is constrained to independent axial translation, physically preventing the possibility of multiple cables tangling during reciprocating push-pull. To improve fatigue resistance under small dimensions and maintain axial stiffness for long-distance transmission, the first steel wire 510, the second steel wire 520, the sliding pin cable 530, and the outer tube cable 130 are preferably made of cobalt-chromium alloy. In addition, the outer sleeve cable 130 is mainly used to transmit motion input from the proximal sleeve tensioning member 120 to the distal end in order to coordinate the covering and detachment states of the outer sleeve.

[0052] Regarding the mapping and mechanical transformation mechanism from the power source to the remote actuator, combined with Figure 12 The force relationship is determined by the fact that the three sets of cables are connected to independent mechanical fulcrums to support the dual-claw gripping logic on both sides.

[0053] For independent rotation control of the short arm, the distal end of the first steel wire 510 extends into a central fixed arm 200, tightly wraps around the upper cylindrical surface of the sliding pin 410, and then directly enters the hollow wiring cavity inside the first long arm 310, extending eccentrically to the outer periphery of the first short arm pivot 330. Symmetrically, the distal end of the second steel wire 520 wraps around the lower cylindrical surface of the sliding pin 410, enters the hollow wiring cavity of the second long arm 340, and extends eccentrically to the outer periphery of the second short arm pivot 360. When the distal ends are in the open state, the first short arm pivot 330 and the second short arm pivot 360 are radially away from the central axis, causing the first steel wire 510 and the second steel wire 520 to form an acute angle with the central axis under the rigid limiting guidance of the long arm cavity, creating a V-shaped trajectory that tilts and diverges to both sides. This structural feature allows the linear tension input from the proximal end to act tangentially on the offset short arm pivot along the inclined inner cavity guide trajectory. Mechanically, this force path converts the axial tension into a driving torque that rotates around the short arm pivot axis, thereby overcoming the preload of the coil spring 610 and driving either the first short arm 320 or the second short arm 350 to perform independent engagement actions. Furthermore, the first steel wire 510 and the second steel wire 520 are in a preloaded state after assembly, and the preload they provide, combined with the folding storage structure, ensures reliable unfolding after the actuator extends out of the outer sleeve 110. More importantly, the concealed wiring design of the bypassing sliding pin allows the steel wire and the sliding pin to maintain relative movement during axial translation, effectively preventing mechanical interference between them.

[0054] For the linear translation control of the sliding pin, the distal section of the sliding pin cable 530 is centeredly connected to the central part of the sliding pin 410. Through this centered connection, the traction force transmitted by the sliding pin cable 530 can act evenly and symmetrically on the geometric center axial symmetry plane of the sliding pin 410. This structural feature ensures that the direction of the tension is coplanar with the sliding axis of the sliding pin 410 within the slide groove 250, thereby reducing the radial overturning moment applied to the sliding pin 410 due to eccentric tension, suppressing the risk of the sliding pin 410 getting stuck against the side wall of the slide groove 250 during forced movement, and ensuring the smoothness and stability of the converging and overturning motion of the two long arms.

[0055] To enable the actuator to remain independently in the body and transform into an implant after completing wound flipping and closure locking, the device is equipped with an axial separation mechanism based on radial constraint release and tension threshold triggering.

[0056] In the arrangement of the separation interface between the pipe body and the cable, combined with Figure 11The cross-sectional view shown indicates that the central fixed arm is physically severed in a specific axial plane near the actuating end, dividing it into a front section 210 and a rear section 220 of the central fixed arm. Correspondingly, the first steel wire 510, the second steel wire 520, the sliding pin cable 530, and the outer tube cable 130, all passing through the guide cavity, are severed into a distal dwelling section and a proximal traction section within approximately the same axial range. The separation cuts of the aforementioned components are spatially arranged side-by-side, forming a synchronously triggered integrated release interface array.

[0057] In the specific docking interface construction, the proximal end face of the front section 210 of the central fixed arm integrally extends a first flexible mating end 230 with a ring-shaped or barbed protrusion, and the inner wall of the distal end face of the rear section 220 of the central fixed arm is provided with a complementary recess, which defines the second flexible mating end 240. Similarly, the distal end of each group of cables is fixed with a plug 540 with a locally enlarged outer diameter (e.g., in the shape of a mushroom head or a cylindrical boss), and the proximal end of each group of cables is fixed with an elastic receiving cavity with an open opening, i.e., a plug seat 550 (e.g., in the shape of a C-shaped claw or a U-shaped seat). In order to cover different mechanical connection variations, this embodiment uniformly defines the above-mentioned male and female plug-in relationship as a restricted connection structure. The criteria for determining the restricted connection structure are: a mechanical interference surface that resists axial displacement is established on the installation interface, and after the radial constraint is released, the interference surface can be released from constraint by radial yielding deformation under the action of a specific threshold external force. To achieve the aforementioned radial yielding deformation, the second flexible mating end 240 and each plug seat 550 may have multiple axially extending clearance slots evenly distributed circumferentially on their tube walls, or they may be made of medical elastic polymer material, so that when the outer rigid sleeve is lost, its circumferential sidewalls can expand radially outward, thereby allowing the internal male component to detach from the required physical space.

[0058] In terms of the mechanical logic and working condition coordination of separation triggering, combined with Figure 9 and Figure 10 In the unseparated state shown, the outer sleeve 110 is coaxially fitted around the outer periphery of the central fixed arm. The rigid inner wall of the outer sleeve 110 tightly covers the periphery of the engagement area between the front section 210 and the rear section 220 of the central fixed arm. The outer sleeve 110 provides a radial physical boundary for the second flexible mating end 240 and each internal insertion seat 550, restricting the degree of freedom of the female components to expand outward. Under this radial constraint, the axial interference relationship between the male and female mating surfaces is forcibly locked, thereby ensuring that the transmission system can stably transmit thrust and pull forces bidirectionally during normal gripping, pulling, and flipping operations.

[0059] Once the remote execution level completes the edge overlap closure and the sliding pin 410 achieves anti-retraction self-locking within the locking groove 260, the operator moves the engagement area of ​​the central fixed arm out of the coverage area of ​​the outer sleeve 110 through relative axial displacement. At this time, the radial space restriction on the second flexible mating end 240 and each plug seat 550 is released, and the structure obtains the preconditions for elastic deformation. Subsequently, when the axial retraction force applied by the operating end exceeds the preset safety tensile force threshold, the geometric slope of the mating interface converts the axial load into a radial component force that causes the female head component to open.

[0060] Under this mechanical environment, the second flexible mating end 240 and each plug socket 550 overcome the elastic potential energy of the material and undergo radial outward yielding deformation. Once the radial opening size exceeds the maximum outer diameter envelope of the corresponding male component, the original axial mechanical interference surface instantly fails. As a result, all control lines at the proximal end, the rear section 220 of the central fixation arm, and the outer sleeve 110 as a whole gain the freedom to retract backward; while the claw assembly with hook teeth 370 at the distal end and the front section 210 of the central fixation arm act as independent closing clamps, physically detaching from the external connection and ultimately remaining at the location of the lesion tissue to complete full-thickness closure.

[0061] Based on the aforementioned multi-level articulation mechanism, locking mechanism, and separation mechanism, this endoscopic reversible double clamp exhibits dynamic morphological intervention capabilities for large-area perforations and everted wound edges during endoscopic surgery. This instrument can forcibly alter tissue orientation through mechanical displacement to achieve full-thickness closure. Its specific operational procedure and tissue interaction process include the following five stages.

[0062] During the target approach and work span establishment phase, combined with Figure 4 The operator manipulates the instrument to extend the central fixed arm 200, carrying the distal actuator, out of the distal opening of the outer sleeve 110, freeing it from the radial constraint of the outer sleeve wall. At this time, the sliding pin 410 is positioned at the farthest limit of the sliding groove 250, and the first long arm 310 and the second long arm 340, pivoting on the sliding pin 410, extend radially to both sides, presenting the maximum V-shaped opening angle. This radial expansion dimension establishes a macroscopic working span in space sufficient to cover the perforation gap between the first tissue 710 and the second tissue 720. At the same time, the first short arm 320 maintains its initial opening offset angle relative to the first long arm 310, and the second short arm 350 maintains its initial opening offset angle relative to the second long arm 340, thereby defining independent capture windows on both sides. Since the wound edges of the first tissue 710 and the second tissue 720 are affected by the intrinsic muscle layer tension and present an original shape that is turned outward away from the central axis, the open capture window is oriented directly towards the outwardly turned tissue sidewall in space, completing the initial geometric capture alignment.

[0063] During the independent dual-point insertion and eversion curing stages, combined with Figure 5The axial position of the sliding pin 410 remains fixed, maintaining a stable extension angle of the long arm. Based on this, the operator pulls the first wire traction member 511 and the second wire traction member 521 proximally. This pulling force is transmitted distally through the first wire 510 and the second wire 520, overcoming the preload of the coil spring 610. This drives the first short arm 320 to partially pivot around the first short arm pivot 330 towards the first long arm 310, and the second short arm 350 to partially pivot around the second short arm pivot 360. The hook teeth 370 on the short arms physically penetrate and engage the tissue. Through leverage amplification, the tip of the short arm generates an adaptive gripping force, thereby establishing rigid mechanical anchoring points at the wound edges of the first tissue 710 and the second tissue 720, respectively. In this state, the instrument only exerts a local normal clamping force on the tissue. Since the long arm has not yet performed a retraction action, the first tissue 710 and the second tissue 720 still maintain their original outward flipping shape, that is, the wound layer is still in a direction away from the central axis.

[0064] During the dynamic traction and forced rollover intervention phase, combined with Figure 6 And refer to Figures 5 to 7 During the displacement process, the operator pulls the sliding pin traction component 531 proximally. This pulling force is transmitted through the sliding pin cable 530, causing the sliding pin 410 to be subjected to axial traction within the sliding groove 250, and to begin translating proximally along the central fixing arm 200. Forced by the axial displacement of the sliding pin 410, and under the combined or independent intervention of the distal retention resistance formed after the short arm engages the tissue, and / or the proximal edge of the outer sleeve 110 extending forward to abut against the outer wall of the long arm when the central fixing arm 200 retracts relative to the outside, the first long arm 310 and the second long arm 340 synchronously perform radial convergence rotation towards the central axis. In this complex motion conversion, the straight guide trajectory of the sliding groove 250 and the radial movement of the long arm hinge point, combined with the physical boundary provided by the tissue anchoring point and / or the end of the outer sleeve 110, smoothly transform the axial tensile force into the centripetal force of synchronous convergence of the two long arms, successfully constructing a dual-clamp synchronous convergence mechanism, greatly ensuring the symmetry and accuracy of wound edge alignment. This composite motion trajectory, through the aforementioned established mechanical anchoring points, simultaneously applies an axial lifting force proximally and a radial cohesive force toward the central axis to the first tissue 710 and the second tissue 720. Under the forced action of the aforementioned composite vector force, the tissue overcomes its own retraction tension, and its morphological spatial orientation undergoes a sudden change, from an outward-turned state away from the central axis to an inward-turned state toward the central axis. This forces the serous membrane layer, which was originally exposed outside the lumen, back to the working axis region, providing the necessary geometric conditions for subsequent full-layer alignment.

[0065] During the terminal alignment and mechanical pressure surface formation stage, combined with Figure 7The sliding pin 410 moves to the physical limit position near the proximal end of the sliding groove 250, and the flexible locking wing 420 springs open and abuts against the stepped end face of the locking groove 260 to achieve self-locking. At this time, the first long arm 310 and the second long arm 340 are completely converged, and their main axes are basically parallel to the central axis of the central fixing arm 200. During this stroke, the wound edges of the first tissue 710 and the second tissue 720 are forcibly dragged and confined to both sides of the central fixing arm 200, reducing the radial relative distance between the two tissues to a minimum. Under the radial compression of the long and short arm assemblies, the wound edges of the first tissue 710 and the second tissue 720 make back-to-back positive contact and form a pressure-overlapping area. The physical gap of the perforation is eliminated, and the tissue morphology is restricted to a full-layer overlapping and adhering state by the rigid boundary formed by the long and short arm assemblies.

[0066] During the physical boundary decoupling and implant residence phase, combined with Figure 8 By applying an axial tensile force exceeding a set threshold proximally, the front section 210 and rear section 220 of the central fixation arm are physically decoupled, and the transmission cables are physically disconnected simultaneously. Preferably, the operator triggers a single-point synchronous release component proximally to apply an axial tensile force exceeding a set threshold to all internal transmission cables. With the radial constraint of the outer sheath 110 already released, this uniformly applied parallel load forces the connectors 540 and 550 of the multi-strand cables to simultaneously overcome mechanical interference and physically disconnect at the same instant, while simultaneously decoupling the front section 210 and rear section 220 of the central fixation arm. This single-point synchronous release mechanism eliminates the risk of asynchronous tripping caused by different frictional resistances of the various wires within the curved channels of the endoscope, completely avoiding the clinical hazard of asymmetrical off-center load torque on the distal clamp due to disconnecting cables one by one, which could lead to secondary tissue tearing. Subsequently, the rear section 220 of the central fixation arm, the proximal withdrawal section of the outer sheath 110, and the proximal control lines are withdrawn proximally as a whole. At this point, the distal end of the outer sheath 110, the anterior end of the central fixation arm 210, the sliding pin 410, and the distal components of the closed long and short arms are no longer constrained by external transmission components, and are physically transformed into an independent closed implant. Relying on the external radial constraint provided by the outer sheath 110 and the internally solidified mechanical locking state, this implant continues to apply a transverse normal clamping force to the first tissue 710 and the second tissue 720 to maintain their overlapping and adherent state, providing a long-term and stable mechanical constraint environment for the full-thickness biological healing of the wound.

[0067] Based on the aforementioned mechanical architecture and dynamic intervention methods, in order to ensure the safety limits of the instrument under extreme endoscopic operating environments and to cover feasible alternatives in industrial manufacturing, this embodiment defines the core dynamic parameters, material selection, and equivalent variation space of the structure as follows.

[0068] In the calibration of core dynamic parameters at the execution level, the adaptive gripping force generated by the tips of the first short arm 320 and the second short arm 350 is set within the range of 1.5~2N. The lower limit of this mechanical range is determined by the critical force boundary at which the uneven, high-tension wound edge undergoes mechanical slippage during traction and flipping; the upper limit of this range is determined by the yield boundary at which fragile lesion tissue with local inflammation or edema undergoes physical tearing under pressure. In addition, for long-distance transmission cables (including the first steel wire 510, the second steel wire 520, and the sliding pin cable 530), their wire diameter and material tensile strength must meet the following requirements: under the complex spatial curvature constraints of the endoscopic bending working channel, they must still maintain an extremely low axial tensile deformation rate to ensure the lossless conversion of proximal displacement input to distal torque output.

[0069] Regarding the replacement principles in materials engineering and manufacturing processes, the rigid clamping components that directly interfere with human tissue (such as the first long arm 310, the first short arm 320, etc.) and the central fixing arm 200 that transmits load-bearing force are preferably made of medical-grade stainless steel, cobalt-chromium alloy, or nickel-titanium alloy. This selection criterion is based on balancing the local bending stiffness required for deep tissue insertion with fatigue resistance under conditions of minimal machining dimensions. Those skilled in the art should understand that, provided that mandatory biocompatibility testing standards for medical devices are followed, the aforementioned parts can be replaced with other polymer engineering materials or composite materials with equivalent yield strength and Young's modulus; such basic materials science replacements all fall within the protection scope of this disclosure.

[0070] Regarding the equivalent evolution and judgment criteria of the mechanical structure, although this embodiment uses the fit between the elongated groove 250 on the central fixed arm 200 and the cylindrical sliding pin 410 as an example to illustrate the axial guiding and anti-eccentric load mechanism, its technical essence lies in the extraction of axial translational degree of freedom and the rigid limitation of radial and circumferential displacement. Therefore, any variation design that uses dovetail grooves, linear guides, or anti-rotation splines to equivalently replace the pin groove fit, and follows the above-mentioned degree of freedom constraint criteria, does not deviate from the design concept of this invention.

[0071] Similarly, the coil spring 610, arranged outside the first short arm pivot 330 and the second short arm pivot 360, essentially functions to establish the initial opening bias torque. In actual manufacturing, the coil spring 610 can be completely replaced by a leaf spring or a torsional elastic cylinder. This replacement of the elastic element is strictly defined as requiring the following criteria to be met: maintaining the same elastic energy accumulation mode and release direction as in the embodiment, and the energy transfer path must be sufficient to provide the reverse torque to overcome the sliding friction of the elastic pawl 620.

[0072] It should be noted that the specific embodiments described above are exemplary. Those skilled in the art can devise various solutions inspired by the disclosure of this invention, and these solutions all fall within the scope of this invention and its protection. Those skilled in the art should understand that this specification and its accompanying drawings are illustrative and not intended to limit the scope of the claims. The scope of protection of this invention is defined by the claims and their equivalents. This specification contains multiple inventive concepts; terms such as "preferredly," "according to a preferred embodiment," or "optionally" indicate that the corresponding paragraph discloses an independent concept. The applicant reserves the right to file divisional applications based on each inventive concept.

Claims

1. A reversible double clamp for digestive endoscopy, characterized in that, include: A guide sleeve is coaxially sleeved on the outermost layer, and a central fixing arm (200) passes through the guide sleeve. A groove (250) is defined on the central fixing arm (200) along the central axis direction. The remote execution component includes a sliding pin (410) that extends laterally through the slide (250) and is subject to controlled translation, and two sets of single-sided gripping units that are symmetrically distributed with respect to the central fixed arm (200). Each of the single-sided grasping units includes a long arm constituting a first-level hinge and a short arm constituting a second-level hinge. The proximal ends of the first long arm (310) and the second long arm (340) are coaxially pivotally connected to the outer peripheral surface of the sliding pin (410). The first short arm (320) is pivotally connected to the distal end of the first long arm (310), and the second short arm (350) is pivotally connected to the distal end of the second long arm (340). The short arm is controlled to perform a biting action independently of the corresponding long arm. When the sliding pin (410) is axially translated proximally in a controlled manner, the distal anchoring resistance formed after the short arm occlusal tissue, and / or the relative mechanical abutment between the distal end of the outer sleeve (110) and the inclined outer wall of the long arm, enable the first long arm (310) and the second long arm (340) to perform a radial closing action around the sliding pin (410).

2. The dual clamp according to claim 1, characterized in that, A one-way check mechanism is provided at the pivot joint between the first short arm (320) and the first long arm (310), and at the pivot joint between the second short arm (350) and the second long arm (340). The one-way check mechanism includes a shaft base shell (600), a coil spring (610) sleeved on the short arm shaft, and an elastic pawl (620) integrally formed on the side wall of the shaft. Within a preset safe range of digestive tract tissue tension, the end face of the elastic pawl (620) abuts against the limiting surface of the annular toothed groove (630) inside the shaft base shell (600) to rigidly lock the degree of freedom of the short arm to open in the reverse direction. The one-way check mechanism is provided with an overload release chamfer at the limiting transition point. When a reverse operating force exceeding a preset threshold is applied to the short arm through the proximal end, the one-way check mechanism undergoes overload retraction to release the check state.

3. The dual clamp according to claim 1 or 2, characterized in that, On the inner working surfaces of the first long arm (310) and the first short arm (320) facing each other, and on the inner working surfaces of the second long arm (340) and the second short arm (350) facing each other, a plurality of anti-slip hook teeth (370) are continuously arranged along the axis. In the initial state without external traction, the distal end of each of the short arms is offset outward relative to the inner side of the corresponding long arm to define an initial V-shaped capture window on each side.

4. The dual clamp according to any one of claims 1 to 3, characterized in that, It also includes an operation control assembly distributed on the proximal control surface, which includes a wire traction member for controlling the engagement of the short arm and a sliding pin traction member for controlling the translation of the sliding pin (410). The wire traction member is equipped with a mechanical linkage lock that cooperates with the sliding pin traction member; the mechanical linkage lock is configured to lock the wire traction member and the sliding pin traction member together axially in the closed state, so that when the sliding pin (410) is pulled towards the proximal end, the cable controlling the short arm engagement can be pulled synchronously and equidistantly to compensate for displacement difference and maintain gripping force.

5. A reversible double clamp for digestive endoscopy, comprising a central fixation arm (200), a sliding pin (410) controlled to translate within the central fixation arm, and a long and short arm grasping assembly pivotally connected to the sliding pin, characterized in that, The internal structure incorporates a concealed transmission system to avoid spatial strangulation interference. The first long arm (310) and the second long arm (340) of the long and short arm gripping assembly are both axially defined with hollow wiring cavities inside; The first wire (510) and the second wire (520) used for independently controlling the biting action of the short arm, after passing through the central fixed arm (200), respectively wrap around the cylindrical surface of the sliding pin (410) at least once, and then pass into the hollow wiring cavity of the first long arm (310) and the second long arm (340) respectively and extend to the distal end. The translational interference experienced by the cable is converted into a wrap angle following the surface of the sliding pin (410), thus physically avoiding the axial translational trajectory of the sliding pin (410).

6. The dual clamp according to claim 5, characterized in that, After the distal end of the first steel wire (510) passes through the first long arm (310), it is eccentrically connected to the outer peripheral edge of the first short arm pivot (330); after the distal end of the second steel wire (520) passes through the second long arm (340), it is eccentrically connected to the outer peripheral edge of the second short arm pivot (360); so as to convert the axial tension into a driving torque that overcomes the elastic preload and rotates around the axis of the short arm pivot.

7. A reversible double clamp for digestive endoscopy, comprising a central fixation arm (200), a long and short arm grasping assembly, and an outer sleeve (110) coaxially sleeved around the central fixation arm (200), characterized in that, Includes a synchronous separation mechanism based on radial constraint release to convert the closed distal component into an implant: The central fixed arm (200) is divided into a front section (210) and a rear section (220) on a specific axial plane; the proximal end of the front section (210) of the central fixed arm is provided with a first flexible mating end (230), and the distal end of the rear section (220) of the central fixed arm is provided with a second flexible mating end (240) with complementary shape. The outer sleeve (110) is provided with a preset separation break along the axial direction to divide the outer sleeve into a proximal withdrawal section and a distal retention section; in the unseparated state, the rigid inner wall of the distal retention section of the outer sleeve (110) covers the periphery of the joint area, providing a constraint boundary to limit radial expansion for the second flexible mating end (240); In the separated state, the rear section (220) of the central fixed arm retracts proximally, allowing the second flexible mating end (240) to move out of the outer sleeve coverage area and gain space for outward expansion and retraction, thereby relieving axial mechanical interference and releasing the front section (210) of the central fixed arm; at the same time, the outer sleeve (110) is physically decoupled at the preset separation break, its proximally retracting section retracts proximally, and the distal stationary section of the outer sleeve (110) remains in the body, so as to lock the rotational degree of freedom of the long and short arm gripping assembly through external radial limiting and maintain the closed state.

8. The dual clamp according to claim 7, characterized in that, The multiple transmission cables passing through the central fixed arm (200) are all cut into a distal dwelling section and a proximal traction section within approximately the same axial range; each cable has a connector (540) fixed at the end of the distal dwelling section and an elastic connector (550) fixed at the end of the proximal traction section; the elastic connector (550) can simultaneously undergo radial retraction deformation to release the connector (540) when it moves out of the coverage area of ​​the outer sleeve (110).

9. The dual clamp according to claim 7 or 8, characterized in that, It also includes a single-point synchronous release component set on the near-end control surface; the near-end traction section of the multi-strand transmission cable is uniformly mounted on the single-point synchronous release component so that when triggered, a uniform parallel axial retraction force is applied to each internal transmission cable, forcing the multi-strand cable and the joint area of ​​the central fixed arm to break through mechanical interference and complete physical release at the same instant, thereby eliminating the asymmetric off-center load torque.

10. The dual clamp according to any one of claims 1 to 9, characterized in that, The central fixed arm has a sliding groove (250) with a laterally enlarged snap-fit ​​groove (260) defined at its proximal end; the bottom of the sliding pin (410) is fixed with a flexible snap-fit ​​wing (420); when the sliding pin (410) moves into the snap-fit ​​groove (260), the flexible snap-fit ​​wing (420) expands radially and forms an axial interference with the snap-fit ​​groove (260) to block the sliding pin (410) from retracting to the distal end.