An endoscope-assisted hemostatic device and an endoscope

Abstract

The application provides an endoscope-assisted hemostasis device and an endoscope, and relates to the field of medical devices. The endoscope-assisted hemostasis device comprises a sheath tube, a crushing assembly and a driving assembly. The sheath tube comprises opposite distal and proximal ends. The crushing assembly is located at the distal end of the sheath tube and at least partially outside the sheath tube. The driving assembly is at least partially arranged in the sheath tube. The driving assembly and the crushing assembly are in transmission connection. The driving assembly can drive the crushing assembly to move to form a crushing action. The application actively and efficiently solves the core problem of removing semi-coagulated blood clots in endoscopic surgery in a mechanical crushing manner, and significantly improves the efficiency and safety of subsequent hemostasis operations.

Description

Technical Field

[0001] This application relates to the field of medical devices, and more particularly to an endoscopic-assisted hemostasis device and an endoscope. Background Technology

[0002] In endoscopic surgery, rapid and precise hemostasis of bleeding points is one of the core procedures. Clinically used, highly effective hemostatic techniques, such as injecting hemostatic agents, placing hemostatic clips, electrocoagulation, or spraying tissue adhesive, all require direct application to the bleeding wound itself to be effective. However, when dealing with persistent bleeding caused by ruptured small or medium-sized veins, a heterogeneous, gelatinous, semi-coagulated blood clot (commonly known as a "blood cake") often forms at the wound site. This clot completely obscures the source of bleeding, blurring the surgical field and making it impossible for the surgeon to accurately locate and treat the actual bleeding point. This not only leads to hemostasis failure or delay, increasing the risk of complications, but may also result in prolonged surgery time and wasted supplies.

[0003] Typically, the removal of such blood clots during surgery relies mainly on the "water spraying combined with negative pressure suction" function of the endoscopic instruments. However, this method has significant limitations: the water pressure generated by the water spray can usually only disperse the liquid portion around the blood clot, and often fails to effectively break up the gelatinous semi-coagulated core, sometimes even causing it to adhere more tightly to the mucosa; while standard negative pressure suction is difficult to remove large, viscous semi-coagulated substances, easily causing blockage of the suction tube or suction port, resulting in low debridement efficiency or even interruption of the operation. Summary of the Invention

[0004] In view of this, the purpose of this application is to overcome the shortcomings of the prior art and provide an endoscopic-assisted hemostasis device and endoscope, which actively, efficiently and safely solves the core problem of removing semi-coagulated blood clots in endoscopic surgery through mechanical fragmentation, and significantly improves the efficiency and safety of subsequent hemostasis operations.

[0005] This application provides the following technical solution: In a first aspect, embodiments of this application provide an endoscopic-assisted hemostasis device, the endoscopic-assisted hemostasis device comprising: A sheath tube, the sheath tube comprising a distal end and a proximal end; A crushing assembly, the crushing assembly being located at the distal end of the sheath tube and at least partially outside the sheath tube; A drive assembly is at least partially disposed within the sheath tube, and the drive assembly is pulverically connected to the crushing assembly. The drive assembly is capable of driving the crushing assembly to move in order to perform a crushing action.

[0006] In some embodiments of the first aspect, the driving component includes: A first component, which is movable along the axial direction of the sheath tube; A second component, which is rotatable about an axis parallel to the axis of the sheath tube; wherein the second component is connected to the crushing assembly; A transmission mechanism, which connects the first component and the second component, is used to convert the movement of the first component into the rotation of the second component.

[0007] In some embodiments of the first aspect, the transmission mechanism includes: A spiral fastener is disposed inside the sheath tube, and the spiral fastener has a threaded hole coaxial with the sheath tube. A helical drive component, wherein one end of the helical drive component away from the distal end is connected to the first component, and one end of the helical drive component away from the first component is connected to the second component, the helical drive component and the sheath tube are coaxially arranged, the helical drive component is located in the threaded hole, and the outer peripheral surface of the helical drive component is threadedly engaged with the hole wall of the threaded hole to form a helical pair.

[0008] In some embodiments of the first aspect, the crushing assembly is rotatably connected to the distal end of the sheath about the axis of the sheath, and the crushing assembly has a mounting hole coaxial with the sheath. The second component and the screw drive are coaxially connected, and the second component is slidably inserted through the mounting hole along the axial direction. The second component includes a first stop structure, and the hole wall of the mounting hole has a second stop structure. The first stop structure and the second stop structure form a circumferential limiting fit to prevent relative rotation between the crushing component and the second component.

[0009] In some embodiments of the first aspect, the first member is rotatably connected to the helical drive about the axis of the helical drive; And / or, the first component is a drive wire, which passes through the sheath tube.

[0010] In some embodiments of the first aspect, the spiral fastener and the sheath are interference-fitted. The transmission mechanism further includes a limiting sleeve, which passes through the protective sleeve and is interference-fitted with the protective sleeve. The inner hole of the limiting sleeve includes a first hole segment and a second hole segment connected in sequence. The opening of the first hole segment faces the spiral fastener, and the ends of the first hole segment and the spiral fastener that are close to each other abut against each other. A stepped surface is formed between the first hole segment and the second hole segment. The crushing component has a connecting end that is rotatably inserted through the inner hole of the sheath tube. The connecting end includes a limiting flange that is axially limited between the spiral fixing member and the stepped surface.

[0011] In some embodiments of the first aspect, the crushing assembly includes an adapter and flexible bristles distributed on the outer surface of the adapter, and the adapter and the drive assembly are drively connected.

[0012] In some embodiments of the first aspect, the crushing assembly further includes an adapter and a plurality of blunt turbine blades, each of the blunt turbine blades being distributed on the outer surface of the adapter, the adapter being drive-connected to the drive assembly.

[0013] In some embodiments of the first aspect, the adapter extends axially along the sheath tube and is an elastic structure.

[0014] In some embodiments of the first aspect, the sheath includes a first tube segment and a second tube segment connected sequentially from the distal end to the proximal end, the outer diameter of the first tube segment being larger than the outer diameter of the second tube segment, the first tube segment being used to engage with the inner wall of the instrument channel when the sheath is inserted into the instrument channel of the endoscope.

[0015] In some embodiments of the first aspect, the inner diameter of the first pipe segment is larger than the inner diameter of the second pipe segment, the drive assembly is disposed within the first pipe segment, a shoulder is formed between the inner holes of the first pipe segment and the second pipe segment, and the end of the spiral fastener away from the limiting sleeve abuts against the shoulder.

[0016] In some embodiments of the first aspect, the drive assembly includes a micro motor disposed within the sheath tube, the output shaft of the micro motor being connected to the crushing assembly.

[0017] In some embodiments of the first aspect, the drive assembly includes an ultrasonic generator disposed within the sheath tube, the ultrasonic generator being connected to the crushing assembly for causing the crushing assembly to generate high-frequency vibrations.

[0018] Secondly, this application also provides an endoscope having an instrument channel, wherein an endoscopic-assisted hemostasis instrument, as described in any of the above embodiments, is movably inserted through the instrument channel.

[0019] Compared with the prior art, the endoscopic-assisted hemostasis device of the present invention has the following advantages: By incorporating a fragmentation and actuation component, this device actively applies mechanical force to the blood clot, directly and effectively breaking it up and disrupting its overall structure, overcoming the limitations of fluid flushing. Furthermore, this mechanical fragmentation method does not rely on high-pressure fluid; it physically separates and breaks up the blood clot without further compacting it onto the bleeding wound surface, helping to maintain a clear surgical field. Additionally, the fragmentation component pre-decomposes large blood clots into smaller fragments or pieces, making them easier to remove with negative pressure suction, significantly reducing the risk of blockage and ensuring the continuity and efficiency of the debridement procedure. By actively and efficiently removing blood cakes covering the bleeding point, this instrument can quickly expose the true source of bleeding. This allows the surgeon to accurately perform subsequent hemostatic procedures (such as injection, clamping, electrocoagulation, etc.), improving the success rate and accuracy of hemostasis and reducing the risk of hemostasis failure, delay, or complications due to unclear vision. Moreover, due to the improved debridement efficiency and the avoidance of operational interruptions caused by unclear vision or tube blockage, the overall surgical time is shortened. At the same time, accurate location of the bleeding point can avoid the waste of hemostatic consumables (such as hemostatic clips and tissue glue) caused by blind operation or repeated attempts.

[0020] In summary, the endoscopic-assisted hemostasis device provided in this application solves the core problem of removing semi-coagulated blood clots in endoscopic surgery in a proactive, efficient, and safe manner through mechanical fragmentation, significantly improving the efficiency and safety of subsequent hemostasis operations.

[0021] To make the above-mentioned objects, features and advantages of the present invention more apparent and understandable, preferred embodiments are described below in detail with reference to the accompanying drawings. Attached Figure Description

[0022] To more clearly illustrate the technical solutions of the embodiments of this application, the accompanying drawings used in the embodiments will be briefly introduced below. It should be understood that the following drawings only show some embodiments of this application and should not be regarded as a limitation of the scope. For those skilled in the art, other related drawings can be obtained based on these drawings without creative effort.

[0023] Figure 1 This illustration shows a schematic diagram of the structure of an endoscopic-assisted hemostasis device according to an embodiment of this application from one perspective; Figure 2 This illustration shows a structural schematic diagram from another perspective of an endoscopic-assisted hemostasis device provided in one embodiment of this application; Figure 3 This illustration shows a schematic diagram of the structure of an endoscopic-assisted hemostasis device according to another embodiment of this application.

[0024] Key component symbols and their descriptions: 100 - Sheath tube; 110 - First pipe section; 120 - Second pipe section; 200 - Drive assembly; 210 - Second component; 220 - Spiral fastener; 230 - Spiral drive component; 240 - First component; 300 - Crushing assembly; 310 - Adapter; 320 - Flexible bristles; 330 - Limiting flange; 400 - Limiting sleeve; 410 - First hole section; 420 - Second hole section. Detailed Implementation

[0025] The embodiments of this application are described in detail below. Examples of these embodiments are shown in the accompanying drawings, wherein the same or similar reference numerals denote the same or similar elements or elements having the same or similar functions throughout. The embodiments described below with reference to the accompanying drawings are exemplary and are only used to explain this application, and should not be construed as limiting this application.

[0026] It should be noted that when an element is said to be "fixed" to another element, it can be directly on the other element or there may be an intervening element. When an element is said to be "connected" to another element, it can be directly connected to the other element or there may be an intervening element. Conversely, when an element is said to be "directly" on another element, there is no intervening element. The terms "vertical," "horizontal," "left," "right," and similar expressions used in this document are for illustrative purposes only.

[0027] In this application, unless otherwise expressly specified and limited, the terms "installation," "connection," "linking," and "fixing," etc., should be interpreted broadly. For example, they can refer to a fixed connection, a detachable connection, or an integral part; they can refer to a mechanical connection or an electrical connection; they can refer to a direct connection or an indirect connection through an intermediate medium; they can refer to the internal communication of two components or the interaction between two components. Those skilled in the art can understand the specific meaning of the above terms in this application according to the specific circumstances.

[0028] Furthermore, the terms "first" and "second" are used for descriptive purposes only and should not be construed as indicating or implying relative importance or implicitly specifying the number of technical features indicated. Thus, a feature defined as "first" or "second" may explicitly or implicitly include one or more of that feature. In the description of this application, "multiple" means two or more, unless otherwise explicitly specified.

[0029] Unless otherwise defined, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this application belongs. The terminology used herein in the template description is for the purpose of describing particular embodiments only and is not intended to be limiting of this application. The term "and / or" as used herein includes any and all combinations of one or more of the associated listed items.

[0030] As shown in Figure 1, Figure 2 and Figure 3 As shown, to solve the above-mentioned technical problems, this application provides an endoscopic-assisted hemostasis device, which includes a sheath 100, a fragmentation component 300, and a drive component 200. The sheath 100 includes a distal end and a proximal end. The fragmentation component 300 is located at the distal end of the sheath 100 and is at least partially located outside the sheath 100. The drive component 200 is at least partially disposed inside the sheath 100. The drive component 200 and the fragmentation component 300 are kinetically connected, and the drive component 200 can drive the fragmentation component 300 to move to form a fragmentation action.

[0031] In these embodiments, this embodiment provides an endoscopic-assisted hemostasis device whose overall structure is adapted to the working channel (i.e., instrument channel) of a standard endoscope, and can be directly inserted and used without changing the endoscope.

[0032] The sheath 100 is a slender, hollow tubular structure made of medical-grade stainless steel or a polymer material (such as polyetheretherketone, PEEK), possessing good rigidity and biocompatibility. The outer diameter of the sheath 100 is adapted to the operating length of a standard endoscope. Its distal end (i.e., the front end) has an opening or window for exposing the fragmentation component 300. The proximal end (i.e., the rear end) connects to a handle or docks with an external drive mechanism.

[0033] The fragmentation assembly 300 is disposed on the distal exterior of the sheath tube 100, and can be, for example, a miniature rotary blade or a reciprocating fragmentation tooth structure. For instance, the fragmentation assembly 300 employs a miniature helical blade made of medical-grade 316L stainless steel with a passivated surface to reduce tissue adhesion. This blade is connected to the drive assembly 200 via an axially extending drive shaft and protrudes from the distal end of the sheath tube 100, ensuring free rotation without contacting the wall of the sheath tube 100.

[0034] The drive assembly 200 is at least partially disposed inside the sheath tube 100, and includes a drive shaft and a proximal drive interface. The drive shaft is a flexible metal wire or a hollow micro-motor rotor, extending along the inner cavity of the sheath tube 100. One end is fixedly connected to the crushing assembly 300, and the other end is coupled to an external power source (such as a micro-motor or a manual knob) through the proximal drive interface. When the external power source is started, the drive assembly 200 drives the drive shaft to rotate, thereby driving the crushing assembly 300 to rotate, forming a mechanical crushing action.

[0035] During the procedure, when the endoscope reveals that the bleeding point is covered by a gelatinous blood clot, the operator guides the instrument through the endoscope's working channel to the target area. Upon activation of the drive assembly 200, the fragmentation assembly 300 performs localized, controlled mechanical fragmentation of the blood clot, breaking it down into fine particles. Subsequently, the endoscope's built-in negative pressure suction system can be used to smoothly remove the fragmented blood clot, exposing a clear bleeding wound surface, facilitating subsequent precise procedures such as hemostasis, electrocoagulation, or injection.

[0036] In another embodiment, the sheath tube 100 has independent flushing and / or suction channels within its wall. The outlet of the flushing channel is located near the fragmentation component 300 and is used to simultaneously spray physiological saline during fragmentation, serving to cool, lubricate, and assist in dispersing debris. The inlet of the suction channel is positioned around the fragmentation component 300, allowing for localized negative pressure suction during fragmentation to prevent debris diffusion and improve debridement efficiency. This design further enhances the integration of the procedure and its clinical applicability.

[0037] In another embodiment, the drive assembly 200 integrates a position sensor and a torque feedback module. When the crushing assembly 300 encounters resistance (such as contact with mucous membrane tissue), the system reduces its rotation speed or pauses operation to avoid accidentally damaging normal tissue.

[0038] In some embodiments, the drive assembly 200 includes a first component 240, a second component 210, and a transmission mechanism. The first component 240 is movable along the axial direction of the sheath tube 100. The second component 210 is rotatable about an axis parallel to the axis of the sheath tube 100; wherein the second component 210 is connected to the crushing assembly 300. The transmission mechanism connects the first component 240 and the second component 210, and is used to convert the movement of the first component 240 into the rotation of the second component 210.

[0039] In this embodiment, the drive component 200 of the endoscopic-assisted hemostasis device adopts a purely mechanical motion conversion mechanism, which does not require external motors or complex electronic components, making it particularly suitable for clinical scenarios where resources are limited or high reliability is required.

[0040] The first component 240 is an operating rod or push-pull wire that can slide axially along the sheath tube 100, with its proximal end extending to the instrument handle for manual push-pull operation by the operator. This component is made of high-strength stainless steel wire or nickel-titanium alloy wire, and has good flexibility and fatigue resistance, allowing it to slide smoothly within the cavity of the sheath tube 100 without buckling.

[0041] The second component 210 is a drive shaft that can rotate about a rotation axis parallel to the axis of the sheath tube 100, and its distal end is fixedly connected to the crushing assembly 300 (e.g., a miniature spiral blade). The second component 210 is located inside the sheath tube 100 near the distal end, and its rotation axis coincides with or is parallel to the central axis of the sheath tube 100, ensuring stable and symmetrical crushing action.

[0042] The transmission mechanism is located inside the distal end of the sheath 100, connecting the first component 240 and the second component 210, and is used to efficiently convert the axial linear motion of the first component 240 into the rotational motion of the second component 210. In this embodiment, the transmission mechanism adopts a groove-pin mating structure: A spiral groove (lead angle of 15° to 45°) is formed on the outer peripheral surface of the second component 210; a transverse pin is fixed at the distal end of the first component 240, and the pin is embedded in the groove; when the surgeon pushes the first component 240 distally, the pin slides along the groove, forcing the second component 210 to rotate around its axis; if the first component 240 is pulled in the opposite direction, the second component 210 rotates in the opposite direction.

[0043] With the above structure, the operator only needs to perform a simple push-pull operation at the handle end to drive the distal fragmentation component 300 to achieve forward / reverse rotation, completing the cutting or crushing of semi-coagulated blood clots. The rotation direction corresponds one-to-one with the push-pull direction, making the operation intuitive and responsive.

[0044] Furthermore, to prevent the first component 240 from twisting or shifting during operation, a guide sleeve may be provided at the proximal end of the sheath 100 to constrain the sliding path of the first component 240.

[0045] In other alternative embodiments, the transmission mechanism may also employ a flexible steel cable winding structure, whereby the first component 240 pulls the steel cable wound on the second component 210, generating torque by utilizing the winding angle.

[0046] In some embodiments, the transmission mechanism includes a helical fixing member 220 and a helical transmission member 230. The helical fixing member 220 is disposed inside the sheath tube 100 and has a threaded hole coaxial with the sheath tube 100. The distal end of the helical transmission member 230 is connected to the first component 240, and the distal end of the helical transmission member 230 is connected to the second component 210. The helical transmission member 230 and the sheath tube 100 are coaxially arranged. The helical transmission member 230 is located in the threaded hole, and the outer peripheral surface of the helical transmission member 230 is threadedly engaged with the hole wall of the threaded hole to form a helical pair.

[0047] In this embodiment, the drive assembly 200 employs a precision screw pair mechanism, which efficiently and stably converts the axial push-pull motion of the first component 240 into the rotational motion of the second component 210 through threaded engagement. This structure has advantages such as good self-locking, smooth transmission, and controllable output torque, and is particularly suitable for endoscopic hemostasis scenarios that require precise control of the breaking force.

[0048] The spiral fastener 220 is a hollow cylindrical structure that is fixedly installed inside the sheath tube 100 near the distal end (e.g., by bonding or interference fit to the inner wall of the sheath tube 100). The center of the fastener has a threaded hole coaxial with the sheath tube 100, and the thread type can be a common triangular thread, a trapezoidal thread, or a ball thread.

[0049] The screw drive component 230 is a slender rod-shaped member, coaxially arranged with the sheath tube 100. Its outer circumferential surface is machined with external threads that match the threaded hole, thus forming a screw pair with the screw fixing component 220. The proximal end (the end away from the distal end) of the screw drive component 230 is fixedly connected to the first component 240 (e.g., by pressing, bonding, or integral molding); its distal end (the end away from the first component 240) is rigidly connected to the second component 210, which directly drives the crushing assembly 300.

[0050] The working principle is as follows: When the operator pushes the first component 240 axially at the handle end, the screw drive component 230 moves distally along the axis of the sheath tube 100. However, because its external thread engages with the internal thread hole of the fixed screw fixing component 220, the screw drive component 230 is forced to rotate around its own axis while moving axially. This rotational motion is transmitted to the crushing assembly 300 through the second component 210, causing it to perform the crushing action. Conversely, when the first component 240 is pulled back, the screw drive component 230 rotates in the opposite direction, and the crushing assembly 300 also rotates in the opposite direction.

[0051] Due to the geometric relationship of the helical pair, the helical drive component 230 rotates one revolution for every lead distance it moves. Therefore, the operator can precisely control the number of rotations and speed of the crushing component 300 by controlling the push-pull stroke, thereby achieving quantitative and controllable mechanical crushing.

[0052] For example, if a thread with a lead of 0.5 mm is used, the first component 240 will be pushed forward by 2 mm, and the screw drive component 230 will rotate 4 times, driving the crushing component 300 to complete 4 complete cutting cycles.

[0053] To improve the feel and efficiency of operation, an elastic reset device (such as a compression spring) can be installed in the sheath tube 100 to allow the first component 240 to return to its original position after being released, which facilitates continuous reciprocating operation.

[0054] In other embodiments, the spiral fastener 220 can be integrally machined with the sheath tube 100, that is, the internal thread is directly machined on the inner wall of the distal end of the sheath tube 100, eliminating the need for a separate fastener. Also, the first component 240 and the spiral drive component 230 are integrally formed.

[0055] In some embodiments, the crushing assembly 300 is rotatably connected to the distal end of the sheath 100 about the axis of the sheath 100, and the crushing assembly 300 has a mounting hole coaxial with the sheath 100. The second component 210 and the screw drive 230 are coaxially connected, and the second component 210 is slidably inserted through the mounting hole along the axial direction. The second component 210 includes a first stop structure, and the hole wall of the mounting hole has a second stop structure. The first stop structure and the second stop structure form a circumferential limiting fit to prevent relative rotation between the crushing assembly 300 and the second component 210.

[0056] In this embodiment, to ensure efficient and reliable transmission of driving torque to the crushing assembly 300, while allowing for a certain assembly tolerance or floating space in the axial direction, the crushing assembly 300 and the second component 210 are connected by an axially sliding and circumferentially locking method. This design balances transmission rigidity and assembly convenience.

[0057] The crushing assembly 300 is rotatably connected to the distal end of the sheath tube 100 via a rotating joint. Specifically, the crushing assembly 300 has an overall annular or disc-shaped structure, such as a crushing wheel with multiple radial cutting teeth, and a mounting hole coaxial with the sheath tube 100 is formed at its center. The inner wall of the mounting hole is provided with a second stop structure, such as multiple circumferentially distributed flat keyways, splines, D-shaped cross-section holes, or a pair of symmetrically arranged protrusions / grooves.

[0058] The second component 210 is a slender drive shaft, which is coaxially and fixedly connected to the screw drive component 230 (it can be an integral structure or fastened by adhesive bonding), and is slidably inserted into the mounting hole along the axial direction. The outer circumferential surface of the second component 210 is provided with a first stop structure that matches the second stop structure, such as a flat key, spline, D-shaped section, or corresponding protrusion.

[0059] When the second component 210 is inserted into the mounting hole, the first stop structure and the second stop structure engage with each other to form a circumferential limiting fit, thereby preventing relative rotation between the crushing component 300 and the second component 210. However, since the two are not completely constrained axially, the second component 210 can still slide slightly axially within the mounting hole to avoid jamming due to over-positioning.

[0060] For example, the second stop structure consists of two symmetrical rectangular grooves on the inner wall of the mounting hole, while the first stop structure consists of two corresponding rectangular bosses on the outer periphery of the second component 210. When the bosses are embedded in the grooves, torque can be transmitted through the sidewall contact surface to achieve synchronous rotation; however, the bosses can move freely a certain distance in the groove depth direction (i.e., axial direction).

[0061] In addition, to prevent the second component 210 from completely dislodging from the mounting hole during operation, a limiting flange 330 can be provided at its distal end, or an elastic retaining ring can be provided at the outlet of the mounting hole to limit only the maximum sliding range without affecting the circumferential transmission.

[0062] In some embodiments, the first component 240 is rotatably connected to the helical drive 230 about the axis of the helical drive 230. The first component 240 is a drive wire that passes through the sheath tube 100.

[0063] This embodiment optimizes the specific structure and connection method of the first component 240, so that it has both axial push-pull function and rotational degree of freedom, thereby avoiding internal stress accumulation or motion interference caused by handle twisting or sheath tube 100 bending during operation.

[0064] The first component 240 is specifically implemented as a drive wire, which is inserted into the inner cavity of the sheath tube 100 and extends from the proximal handle to the distal end to connect with the helical drive component 230. The drive wire is made of a material with high tensile strength and low torsional stiffness, such as multi-strand stranded stainless steel wire, nickel-titanium alloy superelastic wire, or carbon steel wire coated with a lubricating layer, to balance flexibility and thrust transmission capability.

[0065] The key point is that the connection between the first component 240 and the helical drive component 230 is a rotatable connection. For example, a ball-and-socket structure or an annular groove is provided at the center of the proximal end face of the helical drive component 230. A ball head or cylindrical pin is fixed to the distal end of the first component 240, the ball head being embedded in the ball-and-socket structure to form a universal joint or pivotal rotating pair. Alternatively, the distal end of the first component 240 passes through a through hole at the proximal end of the helical drive component 230 via a radial pin, but allows free rotation about the axis.

[0066] With the above structure, the first component 240 can freely rotate around the axis of the helical drive component 230 while pushing and pulling the helical drive component 230 along the axial direction of the sheath tube 100. When the operator unintentionally rotates the drive wire while operating the handle, or when the endoscope bends causing the sheath tube 100 to twist, the drive wire can rotate freely without transmitting torque to the helical drive component 230, thus avoiding interference with its controlled helical rotation. This is suitable for operation scenarios involving curved working channels, preventing the drive wire from becoming knotted or stuck due to twisting.

[0067] Example: In clinical procedures, the endoscope may be in an S-shaped bend. If the drive wire and the helical drive component 230 are rigidly fixed, a small rotation at the handle end will translate into a large torque at the distal end, potentially causing the breakage component 300 to activate unexpectedly or damaging the threaded pair. By using a rotatable connection, this risk is effectively mitigated.

[0068] In some embodiments, the spiral fastener 220 and the sheath tube 100 are interference-fitted. The transmission mechanism also includes a limiting sleeve 400, which passes through the sheath tube 100 and is interference-fitted with it. The inner hole of the limiting sleeve 400 includes a first hole segment 410 and a second hole segment 420 connected in sequence. The opening of the first hole segment 410 faces the spiral fastener 220, and the ends of the first hole segment 410 and the spiral fastener 220 abut against each other. A stepped surface is formed between the first hole segment 410 and the second hole segment 420. The crushing assembly 300 has a connecting end that is rotatably inserted through the inner hole of the sheath tube 100. The connecting end includes a limiting flange 330, which is axially limited between the spiral fastener 220 and the stepped surface.

[0069] In this embodiment, to improve the assembly stability, rotational coaxiality, and resistance to axial movement of the distal structure of the instrument, an axial limiting system is integrated inside the distal end of the sheath tube 100. This system consists of a spiral fastener 220, a limiting sleeve 400, and a connecting end of the crushing component 300. Through a combination of interference fit and mechanical stop, this system achieves a high-precision, non-adhesive, and easily assembled miniaturized structural integration.

[0070] The outer circumferential surface of the spiral fastener 220 is fixed to the inner wall of the sheath tube 100 by an interference fit. For example, the outer diameter of the spiral fastener 220 is slightly larger than the inner diameter of the sheath tube 100, and it is pressed into a predetermined position at the distal end of the sheath tube 100. This connection method does not require adhesive, avoiding the impact of high temperature or chemical residues on biocompatibility, while ensuring that the spiral fastener 220 does not undergo axial or circumferential displacement under high torque conditions.

[0071] The limiting sleeve 400 is a hollow cylindrical part, also inserted inside the sheath tube 100, and located on the distal side (i.e., the side furthest from the distal end of the instrument) of the screw fastener 220. The outer circumferential surface of the limiting sleeve 400 also forms an interference fit with the inner wall of the sheath tube 100, thus firmly fixing it inside the sheath tube 100. The inner hole of the limiting sleeve 400 is divided into two sections along the axial direction: The first hole section 410 is located near the screw fastener 220, and its opening faces the screw fastener 220. The second hole section 420 is located on the proximal side of the first hole section 410, and its inner diameter is larger than that of the first hole section 410.

[0072] A stepped surface is formed at the junction of the first hole section 410 and the second hole section 420. This stepped surface is perpendicular to the axis of the sheath tube 100 and serves as a critical axial stop reference surface.

[0073] During installation, the limiting sleeve 400 is pressed into the sheath tube 100 until the distal end face of its first hole section 410 abuts against the proximal end face of the spiral fastener 220, and the two together form a closed and stable axial support cavity.

[0074] The connecting end of the crushing component 300 extends from the distal end to the proximal end and is rotatably inserted into the inner hole of the sheath tube 100 (actually, it is inserted into the threaded hole of the spiral fastener 220 and the first hole section 410 of the limiting sleeve 400). A limiting flange 330 (e.g., an annular flange or a locally thickened section) is provided on the outer periphery of this connecting end, the outer diameter of which is larger than the inner diameter of the first hole section 410 but smaller than the inner diameter of the second hole section 420.

[0075] After assembly, the limiting flange 330 is axially held between the proximal end face of the spiral fastener 220 and the stepped surface of the limiting sleeve 400, forming a reliable axial limit. At the same time, since the limiting flange 330 can rotate freely within the first hole section 410, the crushing component 300 can still rotate smoothly around the axis of the sheath tube 100.

[0076] In some embodiments, the crushing component 300 includes an adapter 310 and flexible bristles 320, the flexible bristles 320 being distributed on the outer surface of the adapter 310, and the adapter 310 being connected to the drive component 200 in a transmission manner.

[0077] Based on the aforementioned mechanical crushing solution, this embodiment provides a low-damage, highly adaptable crushing component 300 structure, which is particularly suitable for removing highly adhesive, unevenly textured gelatinous semi-coagulated blood clots, while minimizing mechanical damage to surrounding fragile mucosal tissues (such as gastric mucosa and intestinal wall).

[0078] The adapter 310 is a rigid base, in the shape of a cylinder, disc, or frustum, with a connection structure (such as a shaft hole, spline groove, or thread) at its near end for transmission connection with the second component 210.

[0079] The flexible bristles 320 are composed of multiple fine, flexible fibers, evenly or in an array distributed on the outer surface (including the sidewalls and / or distal surface) of the adapter 310. The bristle material is selected from one of the following: medical nylon, polyester, polytetrafluoroethylene, stainless steel microfilaments, and shape memory alloy wires.

[0080] The bristles can be fixed to the adapter 310 by the following methods: hot melt embedding (applicable to plastic adapter 310), laser welding or brazing, or injection molding.

[0081] During operation, the drive assembly 200 rotates the adapter 310. The flexible bristles 320 rotate accordingly, their free ends gently brushing, agitating, and gradually peeling away the semi-coagulated blood clot covering the bleeding point. Because the bristles have elastic deformation capabilities, they conform to the contours even when contacting uneven mucosal surfaces, avoiding tissue damage caused by rigid cutting. Simultaneously, the gaps between the bristles allow broken blood clot fragments to pass through smoothly, facilitating subsequent negative pressure suction removal.

[0082] In some embodiments, the crushing assembly 300 further includes an adapter 310 and a plurality of blunt turbine blades, each blunt turbine blade being distributed on the outer surface of the adapter 310, and the adapter 310 being connected to the drive assembly 200 in a transmission manner.

[0083] In this embodiment, the crushing component 300 adopts a blunt turbine blade structure. Through the combined effect of shearing force generated by rotation, centrifugal disturbance and local turbulence, it achieves efficient crushing and peeling of gelatinous blood clots, avoiding the risk of perforation or scratches caused by using sharp blades.

[0084] Multiple blunt turbine blades are evenly distributed circumferentially along the outer periphery of the adapter 310, or they can be arranged in a helical pattern to enhance fluid guidance. Each turbine blade has the following characteristics: No sharp angles, no cutting edges: All edges are rounded or polished to ensure that contact with tissue produces only blunt pushing rather than cutting; The cross-section is airfoil-shaped or arc-shaped: similar to the blades of a miniature water turbine, with a gentle upside surface and a slightly convex backside surface, which can generate local low-pressure areas and shear gradients when rotating.

[0085] During operation, the drive assembly 200 drives the adapter 310 to rotate. The blunt turbine blades rotate accordingly, producing the following synergistic effect on the blood clot surface: The blunt edge of the blade is inserted into the interface between the blood clot and the mucosa, and the blood clot is gradually pried and peeled off through rotational movement; Rotation disturbs the surrounding flushing fluid (such as saline), forming a local high-speed microjet that helps to disperse the blood clot. Centrifugal throwing action: The broken debris is thrown to the periphery by the blades and pushed towards the negative pressure suction port, making it easier for the negative pressure suction port to capture it and prevent blockage.

[0086] In some embodiments, the adapter 310 extends along the axial direction of the sheath tube 100, and the adapter 310 is an elastic structure.

[0087] In this embodiment, the adapter 310 of the crushing component 300 not only serves as an intermediate carrier for torque transmission, but also has elastic deformation capability and axial extension shape, enabling it to actively conform to the tissue contour or instrument bending state during the rotation crushing process, avoiding operation failure or tissue damage due to rigid interference.

[0088] The adapter 310 is generally slender rod-shaped or flexible shaft-like, extending from the proximal end to the distal end along the axial direction of the sheath tube 100. This design allows the crushing functional areas (such as bristles, turbine blades, or cutting teeth) to be distributed over an axial region, rather than being limited to a single end face, thereby expanding the effective range of action.

[0089] Adapter 310 is made of a material with high elastic modulus and fatigue resistance, for example: Nickel-titanium shape memory alloy: It has excellent elasticity and can recover its original shape after large deformation; Polymer elastomer composite structure: the outer layer provides biocompatibility, and the inner core transmits torque.

[0090] When the endoscope is in a bent position, the distal end of the sheath 100 may deviate from the ideal straight path. At this time, the rigid adapter 310 is prone to hard collision with the intestinal wall. However, the elastic adapter 310 of this embodiment can bend locally to avoid contact with tissue while maintaining its rotational crushing function; once the blood clot is cleared and the resistance is reduced, the adapter 310 returns to a coaxial state, ensuring accurate positioning for subsequent hemostasis operations.

[0091] In some embodiments, the sheath tube 100 includes a first tube segment 110 and a second tube segment 120 connected sequentially from the distal end to the proximal end. The outer diameter of the first tube segment 110 is larger than the outer diameter of the second tube segment 120. The first tube segment 110 is used to make a clearance fit with the inner wall of the instrument channel when the sheath tube 100 is inserted into the instrument channel of the endoscope.

[0092] In this embodiment, the sheath tube 100 adopts a stepped structure with axial segmentation and decreasing outer diameter to optimize its assembly performance and operating experience in the endoscopic instrument channel.

[0093] The sheath tube 100 includes the following components connected sequentially along the axial direction from the distal end to the proximal end: First tube segment 110: Located at the distal end of the sheath tube 100, its outer diameter is slightly smaller than the inner diameter of the standard endoscopic instrument channel. For example, when the inner diameter of the instrument channel is 2.8 mm, its diameter is 2.65 to 2.75 mm; when the inner diameter of the instrument channel is 3.2 mm, its diameter is 3.05 to 3.15 mm.

[0094] Therefore, the first tube segment 110 forms a gap fit with the inner wall of the instrument channel, preventing the sheath tube 100 from shaking or becoming eccentric within the channel, and ensuring that the distal fragmentation component 300 is accurately aligned with the target area. It also provides moderate frictional resistance, allowing the operator to clearly perceive the instrument's position and avoid slippage.

[0095] The second tube segment 120 is located proximal to the first tube segment 110, extending to the proximal end of the sheath tube 100, and its length constitutes the main body of the tube. It improves the flexibility and maneuverability of the sheath tube 100 in curved paths. It reduces the contact area with the inner wall of the channel, thereby reducing frictional resistance during long-distance pushing and making operation easier. The two tube segments can be connected by a smooth conical transition or a right-angle step. A conical transition is preferred to avoid stress concentration or jamming when the endoscope is bent.

[0096] In some embodiments, the inner diameter of the first pipe segment 110 is larger than the inner diameter of the second pipe segment 120, the drive assembly 200 is disposed inside the first pipe segment 110, a shoulder is formed between the inner holes of the first pipe segment 110 and the second pipe segment 120, and the end of the spiral fastener 220 away from the limiting sleeve 400 abuts against the shoulder.

[0097] In this embodiment, the sheath tube 100 not only adopts a stepped design on its outer diameter, but also has an inner diameter step in its inner cavity, forming a shoulder structure for supporting and positioning key transmission components, thereby simplifying assembly, enhancing structural stability, and avoiding the use of connection methods such as adhesives or welding that may affect biocompatibility.

[0098] At the junction of the first pipe section 110 and the second pipe section 120, an annular shoulder (i.e., a stepped surface) perpendicular to the axis is formed in the inner hole. This shoulder is naturally formed by the abrupt change in the inner diameter.

[0099] The spiral fastener 220 is installed in the inner cavity of the first pipe section 110, with its end furthest from the limiting sleeve 400 (i.e., the distal end) abutting against the shoulder. The shoulder provides a precise distal stop for the spiral fastener 220, ensuring its axial position within the sheath 100 and preventing poor thread engagement due to assembly deviations. Furthermore, no additional limiting ring or adhesive is required; bidirectional axial constraint with the proximal end against the limiting sleeve 400 and the distal end against the shoulder can be achieved simply by press-fitting.

[0100] In some embodiments, the drive assembly 200 includes a micro motor disposed within the sheath tube 100, the output shaft of which is connected to the crushing assembly 300. Alternatively, in another embodiment, the drive assembly 200 includes an ultrasonic generator disposed within the sheath tube 100, connected to the crushing assembly 300, used to generate high-frequency vibrations in the crushing assembly 300, thus achieving the same crushing effect.

[0101] In some embodiments, this application also provides an endoscope having an instrument channel, wherein an endoscopic-assisted hemostasis device, as described in any of the above embodiments, is movably inserted through the instrument channel.

[0102] Since the aforementioned endoscopic hemostasis device has the above-mentioned technical effects, the endoscope including the endoscopic hemostasis device should have the same technical effects, which will not be elaborated here.

[0103] In all examples shown and described herein, any specific values ​​should be interpreted as merely exemplary and not as limitations; therefore, other examples of exemplary embodiments may have different values.

[0104] It should be noted that similar labels and letters in the following figures indicate similar items. Therefore, once an item is defined in one figure, it does not need to be further defined and explained in subsequent figures.

[0105] The embodiments described above are merely illustrative of several implementation methods of this application, and while the descriptions are specific and detailed, they should not be construed as limiting the scope of this application. It should be noted that those skilled in the art can make various modifications and improvements without departing from the concept of this application, and these modifications and improvements all fall within the protection scope of this application.

Claims

1. An endoscopic-assisted hemostasis device, characterized in that, The endoscopic-assisted hemostasis device includes: A sheath tube, the sheath tube comprising a distal end and a proximal end; A crushing assembly, the crushing assembly being located at the distal end of the sheath tube and at least partially outside the sheath tube; A drive assembly is at least partially disposed within the sheath tube, and the drive assembly is pulverically connected to the crushing assembly. The drive assembly is capable of driving the crushing assembly to move in order to perform a crushing action.

2. The endoscopic-assisted hemostasis device according to claim 1, characterized in that, The driving component includes: A first component, which is movable along the axial direction of the sheath tube; A second component, which is rotatable about an axis parallel to the axis of the sheath tube; wherein the second component is connected to the crushing assembly; A transmission mechanism, which connects the first component and the second component, is used to convert the movement of the first component into the rotation of the second component.

3. The endoscopic-assisted hemostasis device according to claim 2, characterized in that, The transmission mechanism includes: A spiral fastener is disposed inside the sheath tube, and the spiral fastener has a threaded hole coaxial with the sheath tube. A helical drive component, wherein one end of the helical drive component away from the distal end is connected to the first component, and one end of the helical drive component away from the first component is connected to the second component, the helical drive component and the sheath tube are coaxially arranged, the helical drive component is located in the threaded hole, and the outer peripheral surface of the helical drive component is threadedly engaged with the hole wall of the threaded hole to form a helical pair.

4. The endoscopic-assisted hemostasis device according to claim 3, characterized in that, The crushing component is rotatably connected to the distal end of the sheath about the axis of the sheath tube, and the crushing component has a mounting hole coaxial with the sheath tube. The second component and the screw drive are coaxially connected, and the second component is slidably inserted through the mounting hole along the axial direction. The second component includes a first stop structure, and the hole wall of the mounting hole has a second stop structure. The first stop structure and the second stop structure form a circumferential limiting fit to prevent relative rotation between the crushing component and the second component.

5. The endoscopic-assisted hemostasis device according to claim 3, characterized in that, The first component is rotatably connected to the helical drive component about the axis of the helical drive component; And / or, the first component is a drive wire, which passes through the sheath tube.

6. The endoscopic-assisted hemostasis device according to claim 3, characterized in that, The spiral fastener and the sheath are interference-fitted. The transmission mechanism further includes a limiting sleeve, which passes through the protective sleeve and is interference-fitted with the protective sleeve. The inner hole of the limiting sleeve includes a first hole segment and a second hole segment connected in sequence. The opening of the first hole segment faces the spiral fastener, and the ends of the first hole segment and the spiral fastener that are close to each other abut against each other. A stepped surface is formed between the first hole segment and the second hole segment. The crushing component has a connecting end that is rotatably inserted through the inner hole of the sheath tube. The connecting end includes a limiting flange that is axially limited between the spiral fixing member and the stepped surface.

7. The endoscopic-assisted hemostasis device according to claim 1, characterized in that, The crushing component includes an adapter and flexible bristles, the flexible bristles being distributed on the outer surface of the adapter, and the adapter and the drive component being connected in a transmission manner.

8. The endoscopic-assisted hemostasis device according to claim 1, characterized in that, The crushing assembly also includes an adapter and a plurality of blunt turbine blades, each of which is distributed on the outer surface of the adapter, and the adapter and the drive assembly are connected in a transmission manner.

9. The endoscopic-assisted hemostasis device according to claim 7 or 8, characterized in that, The adapter extends along the axial direction of the sheath tube and is an elastic structure.

10. The endoscopic-assisted hemostasis device according to claim 6, characterized in that, The sheath includes a first tube segment and a second tube segment connected sequentially from the distal end to the proximal end. The outer diameter of the first tube segment is larger than the outer diameter of the second tube segment. The first tube segment is used to make a clearance fit with the inner wall of the instrument channel when the sheath is inserted into the instrument channel of the endoscope.

11. The endoscopic-assisted hemostasis device according to claim 10, characterized in that, The inner diameter of the first pipe segment is larger than the inner diameter of the second pipe segment. The driving component is disposed inside the first pipe segment. A shoulder is formed between the inner holes of the first pipe segment and the second pipe segment. The end of the spiral fastener away from the limiting sleeve abuts against the shoulder.

12. The endoscopic-assisted hemostasis device according to claim 1, characterized in that, The drive assembly includes a micro motor disposed inside the sheath tube, and the output shaft of the micro motor is connected to the crushing assembly.

13. The endoscopic-assisted hemostasis device according to claim 1, characterized in that, The driving component includes an ultrasonic generator disposed inside the sheath tube. The ultrasonic generator is connected to the crushing component and is used to cause the crushing component to generate high-frequency vibration.

14. An endoscope, characterized in that, The endoscope has an instrument channel, and the endoscopic-assisted hemostasis device as described in any one of claims 1 to 13 is movably inserted through the instrument channel.

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