WO2023236056A1 - 一种内窥镜手术辅助牵引系统及方法 - Google Patents

一种内窥镜手术辅助牵引系统及方法 Download PDF

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Publication number
WO2023236056A1
WO2023236056A1 PCT/CN2022/097440 CN2022097440W WO2023236056A1 WO 2023236056 A1 WO2023236056 A1 WO 2023236056A1 CN 2022097440 W CN2022097440 W CN 2022097440W WO 2023236056 A1 WO2023236056 A1 WO 2023236056A1
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WIPO (PCT)
Prior art keywords
steering wire
push button
endoscopic surgery
sheath
auxiliary traction
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PCT/CN2022/097440
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English (en)
French (fr)
Inventor
严航
来永得
孔凡斌
王斌
刘向飞
邱筱赛
Original Assignee
上海诺英医疗器械有限公司
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Priority to PCT/CN2022/097440 priority Critical patent/WO2023236056A1/zh
Publication of WO2023236056A1 publication Critical patent/WO2023236056A1/zh

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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/02—Surgical instruments, devices or methods, e.g. tourniquets for holding wounds open; Tractors

Definitions

  • the invention relates to the technical field of medical devices, and specifically relates to an endoscopic surgery-assisted traction system and method, which are used to assist in pulling mucosal tissue under endoscopic surgery.
  • the stripping of diseased submucosal tissue is the core part of the endoscopic submucosal dissection (ESD) operation process, and the exposure of the surgical field between the mucosa and submucosal tissue is the key to safe and smooth operation.
  • ESD endoscopic submucosal dissection
  • tissue clamping and pulling methods use different paths to extend the tissue clamp into the digestive tract. After completing the four-week pre-incision, the tissue clamp is used to clamp and lift the mucosal layer that needs to be peeled off. Pull to fully expose the submucosal layer that needs to be peeled off.
  • the tissue forceps serve as the operator's other auxiliary hand to lift the diseased mucosal layer that needs to be peeled off.
  • Different operators choose different methods for entering the digestive tract with tissue forceps. Some use dual-channel endoscopes, where the tissue forceps pass through one of the endoscopic channels; others use single-channel endoscopes, where the tissue forceps in the instrument channel extend out of the lens to grasp.
  • the tissue forceps after the tissue forceps enter the digestive tract, due to the interaction with the endoscope, There is no connection between them, making the operation extremely difficult; and the process of sending tissue forceps into the digestive tract is cumbersome, which is not conducive to improving the efficiency of the operation.
  • the most ideal method at present should be the "external channel" method, which not only ensures that the tissue forceps maintains a certain connection with the endoscope after entering the digestive tract, which is conducive to control, but also provides an additional instrument channel, and when the tissue forceps enters the human body Also provides protection.
  • the external channel does not take into account the following characteristics of the channel corresponding to the bendable part of the endoscope after being connected to the endoscope. This results in the external channel not being able to function well when the endoscope lens end is actively bent. As the lens curves together, it requires a lot of maneuvering space to position it accurately.
  • the mucosal traction device includes a tube body, a first clip and a traction component.
  • the first clip is installed at the distal end of the tube body, and the traction component is provided with a first action part. and a second action part.
  • the first action part acts on the distal end of the tube body, and the second action part is used to act on the distal end of the endoscope.
  • the traction member is pulled, the distal end of the tube body is in contact with the endoscope.
  • the distal ends of the scope are close to each other and remain fixed.
  • the endoscopic system includes the aforementioned mucosal traction device.
  • Chinese patent document CN102125459B discloses a mucosal retractor, which includes: an endoscope fixing part that can be installed on the distal head of the endoscope; an instrument lifting part that can install surgical instruments; a swing arm, one end of the swing arm is connected to the endoscope The mirror fixed part is movably connected, and the other end of the swing arm is movably connected with the instrument lifting part; a traction part, the distal end of the traction part is connected with the instrument lifting part.
  • CN214017647U relies on metal clips to clamp the diseased tissue and cannot control the traction angle independently, relying only on the deflection of the tip of the endoscope to locate the lesion;
  • CN102125459B is a channel that relies on external force to deflect the lifting sleeve to achieve directional control, rather than the tissue forceps themselves.
  • the bending angle also cannot accurately control the traction angle, and the operating range is limited to the angle that the channel can reach.
  • the existing traction system mainly has the following shortcomings:
  • Tissue forceps cannot be accurately controlled to accurately reach the lesion tissue.
  • doctors control the deflection of the endoscope based on experience, or use external force to squeeze the external channel and directional deformation. These two methods are used to make the tissue forceps reach the lesion.
  • the accuracy is poor and multiple times are required. It can only be realized by operation, and the efficiency is low.
  • the external channel does not take into account the followability of the channel corresponding to the bendable part of the endoscope after being connected to the endoscope. This results in the external channel not being able to bend well with the lens when the endoscope lens end is actively bent. , resulting in a large operating space required.
  • the purpose of the present invention is to overcome the shortcomings of the existing technology, improve the follow-up performance of tissue forceps relative to the endoscope, and increase the locking function of the tissue forceps operating state, so as to achieve accurate positioning to the lesion and rapid and efficient endoscopic examination. Operation.
  • the present invention provides an auxiliary traction system for endoscopic surgery, which includes a traction forceps and a tip cap catheter.
  • the tip cap catheter is adapted to provide independent traction for the endoscope and the traction forceps respectively.
  • the instrument penetration channel; the tip cap catheter has a second bendable section, the length of the second bendable section completely covers the bendable part of the endoscope; the traction forceps has a first bendable section, the second bendable section A bendable section is suitable for bidirectional bending and locking to maintain the bending angle, and the jaws of the traction pliers are suitable for opening and locking to maintain the open and closed state.
  • the tip cap catheter includes a tip cap, a second sheath and a joint connected in sequence, and the joint is used to provide an opening for the traction forceps to enter the second sheath;
  • the tip cap has at least two A through-channel arranged in parallel, including a first through-channel for connecting the second sheath tube and a second through-channel for installing an endoscope, so that the second sheath tube and the endoscope are arranged in parallel;
  • the first through channel is used to pass through the traction forceps, and the second flexible section is located at the distal end of the second sheath.
  • an inwardly protruding step is provided in the second through-channel, and the step is used to block the lens of the endoscope.
  • a barrier between a section of the starting end of the first through-channel and a section of the starting end of the second through-channel to form a barrier section, and a section of the end of the first through-channel and the section of the end of the second through-channel are A section at the end of the second through channel is connected through a gap to form a gap section, and the barrier section is adjacent to the gap section.
  • the length of the notch section is greater than the distance between the step and the distal end surface of the tip cap.
  • the tip cap has a slope at the distal end of the first through-channel.
  • the radial height of the inclined surface is greater than the inner diameter of the first through-channel, and does not exceed 1/2 of the height of the tip cap.
  • the second bendable section has a plurality of notches.
  • the gap penetrates the pipe wall.
  • the inner wall of the gap is provided with a soft membrane.
  • a plurality of the notches extend along the axial direction and are arranged in the radial direction in the following manner: on the same radial section, there are multiple notches spaced along the circumference; or, on the same radial section , there is only one gap that does not cover the circumference; or, on the same radial section, there is only one gap that covers the circumference; in the first two radial arrangements, the positions of the gaps on adjacent radial sections are consistent or staggered.
  • the second bendable section is a single-wall corrugated tube; the outer wall of the single-wall corrugated tube is: a sequentially progressive annular structure; or a single spiral structure; or multiple spiral structures.
  • the traction forceps include a forceps head, a first sheath and a handle connected in sequence; the first sheath has the first bendable section, the first bendable section houses and fixes a steering wire and a handle.
  • Pulling wire one end of the steering wire is connected to the sheath bending control mechanism of the handle, the sheath bending mechanism is adapted to realize the first bendable section of the first sheath by pulling the steering wire in two directions Bidirectional bending and locking to maintain the bending angle; one end of the pulling wire is connected to the clamp head opening and closing control mechanism of the handle, and the other end is connected to the clamp head, and the clamp head opening and closing control mechanism is suitable for bidirectional pulling
  • the pulling wire realizes the opening and closing of the plier head and locks it to maintain the opening and closing state.
  • the first bendable section of the first sheath tube is a multi-layer composite structure, which is a sheath tube, an outer snake bone, a steering wire, a snake bone take-over and an inner snake bone in order from outside to inside; the traction wire accommodates and passes through Inside the inner snake bone; both the outer snake bone and the inner snake bone are suitable for bidirectional bending.
  • the outer snake bone is suitable for bending at 270° in both directions.
  • the inner snake bone is suitable for bending 180° in both directions.
  • the outer snake bone, the inner snake bone and the snake bone take over are fixedly connected at their axial proximal ends; the inner snake bone remains freely movable at one end close to the pliers head.
  • the steering wire is axially arranged on both sides of the first sheath, and is suitable for pulling the steering wire on one side toward the pliers head or away from the pliers head to make the first sheath The sheath bends to different sides.
  • the sheath bending control mechanism includes a bending push button assembly and a roller; the bending push button assembly is slidably located in the middle of the lower cover of the handle, and the roller is fixedly located at the rear of the lower cover; The steering wire is fixed by the curved push button assembly and extends to the roller, and is wrapped tightly around the roller and then turned back.
  • the curved push button assembly includes a second push button seat, the second push button seat is provided with a steering wire fixing interface, and the steering wire is fixed to the steering wire fixing interface; the second push button The seat is slidably located on the inner bottom surface of the lower cover.
  • a second spring is accommodated in the second push button seat.
  • a second blocking block is provided on the top surface of the second spring. The second blocking block has a built-in head. The second screw faces upward, and a second push button is screwed on the second screw.
  • the steering wire at least includes an upper steering wire and a lower steering wire, and the upper steering wire and the lower steering wire are separated or continuous.
  • a first scaling structure of the steering wire is provided on the second push button seat, and the first scaling structure of the steering wire is suitable for At the same time, the effective lengths of the upper steering wire and the lower steering wire are adjusted.
  • the first scaling structure of the steering wire includes an adjustment channel and an adjustment rod.
  • the adjustment channel is a cavity and extends along the length direction of the lower cover.
  • the adjustment rod is perpendicular to the extension direction of the adjustment channel from It penetrates one side wall of the cavity from the outside inward and can be mounted on the other side wall of the cavity in a bidirectional rotation.
  • a through hole is opened radially in the middle section of the adjustment rod; the adjustment channel is used as a guide for the steering wire. Traveling and effective length scaling channel, the steering wire directly wraps around the adjusting rod for a certain number of turns or passes through the through hole and then wraps around the adjusting rod for a certain number of turns.
  • the steering wire includes an upper steering wire, an adjustment steering wire and a lower steering wire in sequence, and the three are continuous;
  • the second push button seat is provided with a second zooming structure of the steering wire, and the steering wire is
  • the second wire scaling structure is adapted to bidirectionally adjust the effective lengths of the upper side steering wire and the lower side steering wire by bidirectionally scaling the length of the adjustment steering wire.
  • the second scaling structure of the steering wire includes an adjustment channel, a left adjuster and a right adjuster.
  • the adjustment channel is a cavity and extends along the length direction of the lower cover.
  • the left adjuster and right adjuster Perpendicular to the extension direction of the adjustment channel, it penetrates one side of the cavity wall from outside to inside and is rotatably mounted on the other side wall of the cavity.
  • the average diameter of the middle sections of the left regulator and the right regulator is A through hole is opened in the direction; the adjustment channel is used as a passage and effective length scaling channel for the steering wire, and the steering wire directly wraps around the left adjuster and the right adjuster for a certain number of turns or passes through each of the channels. After the holes are made, wind the left adjuster and the right adjuster respectively for a certain number of turns.
  • the handle includes an upper cover, and a plurality of slots are provided on the inner top surface of the upper cover; the second block has at least one second protrusion, and the second protrusion is suitable for being embedded in the handle.
  • the slot is used to fix the position of the second push button seat.
  • the upper cover is provided with a chute
  • the second push button extends out of the upper cover through the chute and is adapted to move back and forth along the chute.
  • a guide groove is provided on the upper cover, and the guide groove is suitable for receiving and guiding the steering wire.
  • a guide sleeve is provided in the guide groove.
  • the mouth of the receiving cavity of the second push button seat has a second limiting portion extending inward.
  • the clamp head opening and closing control mechanism includes a clamping push button assembly located at the front of the lower cover of the handle, the clamping push button assembly includes a first push button seat, and the first push button
  • the seat is provided with a traction wire fixing interface, and the traction wire is fixed to the traction wire fixation interface;
  • the first push button seat is slidably located on the inner bottom surface of the lower cover, and the first push button seat accommodates a third push button seat.
  • a spring, a first clamping block is provided on the top surface of the first spring, a first screw with an upward head is built in the first clamping block, and a first push button is screwed on the first screw.
  • the first block has at least one first protrusion, and the first protrusion is adapted to be inserted into a plurality of slots on the upper cover of the handle to fix the position of the first push button seat. .
  • the mouth of the accommodation cavity of the first push button seat has a first limiting portion extending inward.
  • the handle includes a stress diffusion tube, and the stress diffusion tube is docked with the first sheath.
  • the present invention provides an auxiliary traction method for endoscopic surgery, which includes the following steps: inserting the lens of the endoscope into the second through channel provided on the tip cap of the tip cap catheter; A part of the second sheath of the catheter is sent into the target affected area together with the endoscope; deflecting the lens of the endoscope, the second flexible section of the second sheath bends accordingly until the lens of the endoscope finds the target tissue; Stretch the clamp head of the traction forceps into the opening provided on the connector of the tip cap catheter, and enter the first through-channel provided on the tip cap through the second sheath until the clamp head is seen under the endoscope lens; pass The handle of the traction forceps is manipulated to adjust the curvature and/or bending direction of the first sheath of the traction forceps and the second sheath of the tip cap catheter; the opening or closing of the jaws of the traction forceps is adjusted by operating the handle of the traction forceps.
  • the front end of the traction clamp can bend 180° in both directions and twist the tube body 360°. It has a larger operating angle, can cover a larger operating range, reduce the number of operations, and improve efficiency.
  • the part of the tip cap catheter adjacent to the curved part of the endoscope is also a bendable part, and the sheath of the traction forceps accommodated in the inner cavity of the bendable part is also bendable, so that the tip cap catheter serves as The external channel can be bent along with the endoscope, which increases the followability and reduces the required operating space.
  • the bendable section provided on the tip cap catheter and the bendable section of the traction forceps cooperate with each other.
  • the bendable section of the traction forceps is located in the inner cavity of the bendable section of the tip cap catheter, so that the forceps head does not need to completely extend out of the tip.
  • the cap provides convenience for grabbing tissues that are close to the lens of the endoscope, or grabbing distant tissues to the proximal end of the lens for cutting.
  • Figure 1 is a schematic structural diagram of an embodiment of the system of the present invention.
  • Figure 2 is a schematic structural diagram of the traction clamp in one embodiment of the system of the present invention.
  • Figure 3 is a schematic structural diagram of the tip cap catheter in one embodiment of the system of the present invention.
  • Figure 4 is a schematic structural diagram of the tip cap in one embodiment of the system of the present invention.
  • Figure 5 is a schematic structural diagram of the lower cover in one embodiment of the system of the present invention (including the sheath bending mechanism and the clamp head opening and closing control mechanism);
  • Figure 6 is a schematic structural diagram of the clamping push button assembly of the clamp head opening and closing control mechanism in one embodiment of the system of the present invention
  • Figure 7 is a schematic structural diagram of the bending push button assembly of the sheath bending mechanism in one embodiment of the system of the present invention.
  • Figure 8 is a schematic structural diagram of the upper cover in one embodiment of the system of the present invention.
  • Figure 9 is a schematic structural diagram (section) of the first sheath in an embodiment of the system of the present invention.
  • Figure 10 is a usage status diagram of an embodiment of the system of the present invention.
  • Figure 11 is a schematic diagram of the first scaling structure of the steering wire in one embodiment of the system of the present invention.
  • Figure 12 is a schematic diagram of the second scaling structure of the steering wire in one embodiment of the system of the present invention.
  • Figure 13 is a cross-sectional view of the tip cap in the prior art
  • Figure 14 is a cross-sectional view of the tip cap in one embodiment of the system of the present invention.
  • Figure 15 is a diagram showing the use status of the tip cap in one embodiment of the system of the present invention.
  • 2-tip cap catheter 21-tip cap; 211-first through channel; 212-second through channel; 2121-step; 213-notch; 214-slope; 215-interval; 22-second sheath; 221 -The second flexible section; 2211-gap; 23-joint;
  • one embodiment of the endoscopic surgery auxiliary traction system of the present invention includes a traction forceps 1 and a tip cap catheter 2.
  • the tip cap catheter 2 is suitable for the endoscope A and the end cap tube 2 respectively.
  • the traction forceps 1 provide an independent instrument penetration channel; the tip cap catheter 2 has a second flexible section 221, the length of which completely covers the bendable part of the endoscope A; the traction forceps 1 It has a first bendable section, which is suitable for bidirectional bending and locking to maintain the bending angle.
  • the pliers 11 of the traction pliers 1 are suitable for opening and locking to maintain the open and closed state.
  • the positions of the flexible portion of endoscope A and the second flexible section 221 of the tip cap tube overlap and are bound into one body.
  • the two bendable sections 221 are adjacent side by side. As long as the bendable part of the endoscope A performs a bending action, the second bendable section 221 of the tip cap catheter will inevitably bend accordingly. The followability is good and the operating radius can be effectively reduced. .
  • the tip cap catheter 2 includes a tip cap 21 , a second sheath 22 and a connector 23 connected in sequence.
  • the connector 23 is used to provide the traction forceps 1 with access to the second sheath 22 .
  • Opening; the tip cap 21 has at least two parallel passages, including a first passage 211 for connecting the second sheath 22 and a second passage 212 for installing the endoscope A,
  • the second sheath 22 is arranged side by side with the endoscope A; the first through channel 211 is used to pass through the traction forceps 1, and the second flexible section 221 is located distal to the second sheath 22. end.
  • the tip cap 21 is designed as a dual-channel structure.
  • an additional first through-channel 211 is provided, which can be used as an instrument channel for the traction forceps 1, for better Ground-assisted traction creates conditions.
  • the material of the tip cap 21 can be silicone rubber, thermoplastic polyurethane elastomer and other soft polymer materials with certain elasticity. It can be stretched within a certain range and can be used with endoscopic lenses of different specifications. At the same time, the soft material can ensure the safety of the patient's body. Tissue is not damaged.
  • the second sheath 22 connected to the tip cap 21 can be fixed on the endoscope A along with the tip cap 21 to add a channel to the endoscope A to facilitate coordinated surgical operations with multiple instruments under the endoscopic device.
  • the second through-channel 212 is provided with an inwardly protruding step 2121, and the step 2121 is used to block the lens of the endoscope A.
  • the step 2121 is equivalent to an adjuster for the depth of the lens of endoscope A in the second through channel 212.
  • the axial position of the step 2121 in the second through channel 212 can be set according to actual needs, such as For different patients, the location of the lesion can be preliminarily determined based on the advance image information, and accordingly the appropriate position of the step 2121 can be selected, that is, the apex cap 21 of different specifications can be selected.
  • an isolation layer 215 between a section of the starting end of the first through channel 211 and a section of the starting end of the second through channel 212, forming an isolation layer.
  • a section at the end of the first through channel 211 and a section at the end of the second through channel 212 are connected through a gap 213 to form a gap section, and the barrier section is adjacent to the gap section.
  • the length of the notch section is greater than the distance between the step 2121 and the distal surface of the tip cap 21 . In this embodiment, it is ensured that the opening position of the notch 213 is behind the endoscope lens and has better adaptability to instruments such as flexible grasping forceps.
  • the tip cap 21 has a slope 214 at the distal end of the first through channel 211 .
  • the inclined surface 214 is located on the tip cap 21 at a position in direct contact with the human mucosa, which can change the direction of the force applied to the mucosa and increase the force application area, so that the tip cap catheter 2 can enter the human body with the endoscope A. It can separate the mucosa more easily, avoid damage to human tissue, and solve the problem that the front end of the tip cap is too flat, making it difficult to separate the mucosa without damage.
  • the radial height of the inclined surface 214 is greater than the inner diameter of the first through-channel 211 and does not exceed 1/2 of the height of the tip cap 21 .
  • the height of the inclined surface 214 is greater than the inner diameter of the first through-channel 211 , so that the “tip” position formed by the inclined surface 214 and the notch 213 is lower than the first through-channel 211 in radial height.
  • the "partition" between the through channel 211 and the second through channel 212 facilitates the bending movement of instruments such as bendable grasping forceps.
  • the radial height of the bevel 214 is greater than 1/2 of the radial height of the tip cap 1, although the tissue can be separated, such an acute angle may not be conducive to the entry and operation of instruments, and may also affect the field of vision.
  • the second bendable section 221 has a plurality of notches 2211.
  • the multi-slit structure can enhance the flexibility of the second bendable section 221, making it easier to bend and have better followability.
  • the gap 2211 penetrates the pipe wall.
  • the deformation of the gap is large after penetration.
  • the resistance of the gap 2211 in the penetration state is smaller than that of the gap without penetration, that is, it is easier to bend and has better followability.
  • the inner wall of the notch 2211 is provided with a soft membrane.
  • the traction forceps 1 when the traction forceps 1 moves in the inner cavity of the tip cap catheter 2, it may extend to the outside of the gap 2211 in the through state, that is, deviate to the outside of the inner cavity of the tip cap catheter 2, resulting in the failure of the traction forceps 1 to pass through. .
  • a soft membrane is provided on the inner wall of each gap 2211 to cover the through-hole. At this time, the soft membrane essentially plays a guiding role, which can effectively ensure that the traction forceps 1 travels smoothly through the lumen of the tip cap catheter 2.
  • the soft membrane covers the gap inside the tube body, but the gap still exists on the outside. It is easier to process in the through state, but the instrument passability is not good.
  • a soft membrane is installed on the inside of the pipe wall, which is equivalent to a complete pipe, with better guidance, which optimizes the passability of the instrument.
  • the bending performance is better. Because the non-penetrating pipe wall is a whole, the material is harder than the soft membrane, and the pull on the gap is stronger when bending, and the bending flexibility is not as good as the soft membrane.
  • the plurality of notches 2211 extend in the axial direction and are arranged in the radial direction in the following manner: on the same radial cross section, there are multiple notches 2211 spaced apart along the circumference; or, in On the same radial section, there is only one notch 2211 that is not full of the circumference; or, on the same radial section, there is only one notch 2211 that is full of the circumference; in the first two radial arrangements, adjacent radial The positions of the gaps 2211 on the cross section are consistent or staggered.
  • the first radial arrangement is to arrange multiple notches 2211 at the same or different angles on the same circumference, so that they can be easily bent in multiple directions, that is, with multi-directional or full Directional follow-up performance;
  • the second radial arrangement only sets one gap 2211 on the same circumference, and the gap 2211 can only be set in the direction that needs to be bent, so that it can be easily bent in the direction of the gap 2211, and It is easy to bend in the direction opposite to the gap 2211;
  • the third radial arrangement method is equivalent to connecting multiple spaced gaps 2211 into a continuous gap on the basis of the first method, which has better omnidirectional follow-through. mobility.
  • the second bendable section 221 is a single-wall corrugated tube; the outer wall of the single-wall corrugated tube is: a sequentially progressive annular structure; or a single spiral structure; or multiple spiral structures.
  • the single-wall corrugated pipe is equivalent to having continuous gaps on its outer wall, which has better followability.
  • the traction forceps 1 includes a forceps head 11, a first sheath 12 and a handle 13 connected in sequence; the first sheath 12 has the first bendable section, and the first bendable The steering wire 1221 and the pulling wire 127 are accommodated and fixed in the section; one end of the steering wire 1221 is connected to the sheath bending control mechanism of the handle 13, and the sheath bending mechanism is suitable for pulling the steering wire 1221 in two directions.
  • the first bendable section of the first sheath 12 is bent in two directions and locked to maintain the bending angle; one end of the pulling wire 127 is connected to the clamp head opening and closing control mechanism of the handle 13, and the other end is connected to the clamp.
  • the pliers head opening and closing control mechanism is suitable for opening and closing the pliers head 11 by pulling the pulling wire 127 in two directions and locking the pliers head 11 to maintain the open and closed state.
  • a sheath bending control mechanism is provided in the handle 13 of the traction forceps 1 to control the bending angle and bending direction of the first bendable section of the first sheath 12. It can be bent in a certain direction as needed and adjusted to The appropriate bending angle can be locked and maintained at the bending angle after being adjusted in place.
  • a clamp is provided in the handle 13 of the traction clamp 1
  • the head opening and closing control mechanism controls the opening or closing of the pliers 11, and can lock the open or closed state, that is, if it is in the closed state, it will always remain closed, if it is in the open state, the opening size will remain unchanged, No manual maintenance is required.
  • a bidirectional bending angle mark can be set on the side of the sheath bending control mechanism of the handle 13 to make the control of the bending angle clearer.
  • the first bendable section of the first sheath 12 is a multi-layer composite structure, consisting of a sheath tube 121, an outer snake bone 122, a steering wire 1221, a snake bone connecting tube 124 and an inner snake bone in order from outside to inside. 123;
  • the traction wire 127 is accommodated and passed through the inner snake bone 123; both the outer snake bone 122 and the inner snake bone 123 are suitable for bidirectional bending.
  • the snake bone takeover 124 connects the inner snake bone 123 and the outer snake bone 122 at the proximal end, and allows the steering wire 1221 provided on the outer snake bone 122 to pass through the gap between the inner snake bone 123 and the outer snake bone 122 .
  • the outer snake bone 122 and the inner snake bone 123 can be made of stainless steel, nickel-titanium alloy or other metal materials.
  • the pulling wire 127 can be coated with a friction-reducing pipe, and the material is PTFE or other polymer materials.
  • the first sheath tube 12 also includes a common section, and the common section includes an outer sheath tube 125 and an inner tube 126 .
  • the inner tube 126 is connected to the outer snake bone 122.
  • the inner tube 126 is in the form of a flexible snake bone or a spring tube, and is made of stainless steel, NiTi alloy or other metal materials.
  • the guarantee tube 121 covers the outside of the outer snake bone 122, and the outer sheath tube 125 covers the outside of the inner tube 126.
  • the outer sheath tube 125 is made of a polymer material with relatively high lubricating properties, and the guarantee tube 121 is made of a highly elastic polymer material.
  • the guarantee tube 121 is made of a highly elastic polymer material.
  • the opening and closing and bending angles interfere with each other.
  • the tip of the traction forceps 1 adopts a snake bone structure, which can easily realize the two-way 180° bending of the head.
  • the inner snake bone 123 can effectively reduce the deformation or control interference caused by the force of the pulling wire 127 on the outer snake bone 122 when the pliers head 11 is opened and closed.
  • the outer snake bone 122 is adapted to bend 270° in both directions. In this embodiment, the outer snake bone 122 can bend up to 270° in two opposite directions. The outer snake bone 122 is directly adjacent to or in contact with the bendable part of the endoscope A, and its bending angle must be large. The entire first sheath tube 12 has better followability.
  • the inner snake bone 123 is adapted to bend 180° in both directions. In this embodiment, the inner snake bone 123 can bend up to 180° in two opposite directions, so as to better match the outer snake bone 122 and improve the followability of the entire first sheath tube 12 .
  • the axial proximal ends of the outer snake bone 122 , the inner snake bone 123 and the snake bone takeover 124 are fixedly connected; the inner snake bone 123 remains free to move at one end close to the clamp head 11 state.
  • the proximal end (the end close to the handle 13, also called the rear end) of the outer snake bone 122 and the inner snake bone 123 is connected by the snake bone pipe 124, and the distal end (the end far away from the handle 13, also called the front end) ) can move relatively between the outer snake bone 122 and the inner snake bone 123.
  • the outer snake bone 122 bends under force, it drives the inner snake bone 123 to bend.
  • the bending angle of the inner snake bone 123 is smaller than that of the outer snake bone 122.
  • the bending angle is such that the front end of the inner snake bone 123 extends forward relative to the outer snake bone 122.
  • Extended inner snake bone 123 fills in.
  • the steering wire 1221 is axially arranged on both sides of the first sheath 12 and is suitable for pulling one side of the sheath in a direction approaching the pliers 11 or away from the pliers 11 .
  • the steering wire 1221 bends the first sheath 12 to different sides.
  • the steering wire 1221 is a continuous whole and is arranged on both sides of the first sheath tube 12.
  • the first sheath tube 12 can be directed to different sides. bending.
  • only the head end of the steering wire 221 is connected to the front end of the outer snake bone 22.
  • the steering wire 221 passes through the protruding holes provided on the inner wall of the outer snake bone 22.
  • the steering wire 221 When the steering wire 221 is pulled, the steering wire 221 will move relative to the front end of the steering wire 221.
  • the outer snake bone 22 slides to a certain extent. During this process, the length of the steering wire 221 in the outer snake bone 22 becomes shorter, and the outer snake bone 22 will be bent. It should be noted that the purpose of this bending is to fine-tune the position of the endoscope A after it has been bent to an appropriate position, so that the forceps head 11 can be more accurately brought closer to the tissue to be removed.
  • the sheath bending control mechanism includes a bending push button assembly 134 and a roller 135; the bending push button assembly 134 is slidably located in the middle of the lower cover 132 of the handle 13, and the roller 135 is fixedly located.
  • the steering wire 1221 is fixed by the curved push button assembly 134 and extends to the roller 135 , and is wound tightly around the roller 135 before turning back.
  • the steering wire 1221 is guided and folded by the roller 135 and then arranged on both sides of the lower cover 132, which corresponds to the steering wire 1221 being arranged on both sides of the first sheath 12 in the previous embodiment; the steering wire 1221 is fixed.
  • the steering wire 1221 On the curved push button assembly 134, as the curved push button assembly 134 moves, the steering wire 1221 must be pulled. As shown in Figure 5, the curved push button assembly 134 can move to the left or right, with different moving directions. Then the steering wire 1221 receives force in different directions, and finally the steering wire 1221 in the first sheath 12 drives the first sheath 12 to bend to different sides.
  • the curved push button assembly 134 includes a second push button seat 1342.
  • the second push button seat 1342 is provided with a steering wire fixing interface.
  • the steering wire 1221 is fixed to the steering wire fixed interface;
  • the second push button seat 1342 is slidably provided on the inner bottom surface of the lower cover 132, and a second spring 1344 is accommodated in the second push button seat 1342.
  • the second spring A second clamping block 1343 is provided on the top surface of 1344.
  • the second clamping block 1343 has a built-in second screw 1345 with an upward head.
  • a second push button 1341 is screwed on the second screw 1345.
  • the second push button seat 1342 is provided with two steering wire fixing interfaces a and b.
  • the steering wire 1221 enters and exits from the interface a through the interface b.
  • the steering wire 1221 is fixed on the second push button seat 1342. That is, there is no relative motion between the two. It can be seen from Figure 5 that the position of interfaces a and b, that is, the position of the steering wire 1221 on the left side is significantly higher than the steering wire 1221 on the right side.
  • the steering wire 1221 on the left side is located at the first sheath tube 12 after being extended.
  • the steering wire 1221 on the right side in Figure 5 is located on the lower side inside the first sheath tube 12 after being extended.
  • Pushing the second push button 1341 to the left or right causes the second push button seat 1342 to slide to the left or right, causing the steering wire 1221 on the left side in Figure 5 to receive a left or right pulling force.
  • the steering wire 1221a on the left side in Figure 5 will be moved in the direction on the right side of the interface b.
  • the left pulling force, the steering wire 1221b on the right side after being wound and turned back by the roller 135 is pulled to the right, then the steering wire 1221b on the inner and lower side of the first sheath 12 is pulled to the right, and the outer snake bone 122 is turned on the lower side.
  • the wire 1221b is pulled to the right and bends and deforms downward.
  • the inner snake bone 123 is squeezed by the deformation of the outer snake bone 122 and bends and deforms in the same direction as the outer snake bone 123.
  • the second push button 1341 is pushed to the right (that is, in a direction away from the pliers 11, or moved backward)
  • the steering wire 1221a on the left side in Figure 5 will be pushed to the right on the left side of the interface a.
  • the steering wire 1221a on the upper inner side of the first sheath 12 is pulled to the right, the outer snake bone 122 is pulled to the right by the upper steering wire 1221a, and bends and deforms upward, and the inner snake bone 123 is pulled by the outer snake bone 122 to the right. 122 is deformed and squeezed, resulting in bending deformation in the same direction as the outer snake bone 123.
  • the force application direction is changed by the winding and turning of the roller 135, and the bidirectional bending of the first sheath 12 is cleverly realized.
  • the bending angle is related to the moving distance of the second push button 1341, and can be determined according to actual needs.
  • the roller 135 connects the steering wire 1221 with the second push button 1341, so the synchronization is better, and the steering wire on one side is tightened while the steering wire on the other side is relaxed.
  • the steering wire 1221 at least includes an upper steering wire 1221a and a lower steering wire 1221b, and the upper steering wire 1221a and the lower steering wire 1221b are separated from each other. or continuous.
  • the upper steering wire 1221a and the lower steering wire 1221b are separated, that is, they are disconnected, one end of the upper steering wire 1221a ends at the steering wire fixed interface a, and the lower steering wire 1221a ends at the steering wire fixed interface a.
  • One end of the side steering wire 1221b ends at the steering wire fixing interface b.
  • the upper steering wire 1221a and the lower steering wire 1221b are continuous, that is, they are connected together and form a whole body.
  • the cavity allows the steering wire 1221 to pass through, but the steering wire 1221 is fixed at two points: the steering wire fixed interface a and the steering wire fixed interface b.
  • This separable and continuous design can increase the flexibility of use of the steering wire 1221.
  • the effective length of the upper steering wire 1221a and/or the lower steering wire 1221b can be easily adjusted.
  • the so-called effective length is Refers to the actual length involved in the bending operation.
  • the second push button seat 1342 is provided with a first scaling of the steering wire. structure, the first scaling structure of the steering wire is suitable for simultaneously adjusting the effective lengths of the upper steering wire 1221a and the lower steering wire 1221b.
  • the effective lengths of the upper steering wire 1221a and the lower steering wire 1221b can be adjusted simultaneously, and the tightness of the entire device is adjusted accordingly. , including the state of the clamp head 11 in the non-bent state: loose or tight.
  • the first scaling structure of the steering wire includes an adjustment channel and an adjustment rod 1346.
  • the adjustment channel is a cavity and extends along the lower cover 132. Extending in the length direction, the adjustment rod 1346 is perpendicular to the extension direction of the adjustment channel and penetrates one side wall of the cavity from outside to inside and is rotatably installed on the other side wall of the cavity.
  • the adjustment rod 1346 A through hole is provided radially in the middle section of Then wrap the adjusting rod 1346 for a certain number of turns.
  • the adjusting rod 1346 can be a dumbbell-shaped screw.
  • the end face of the head is provided with a horizontal groove, the middle section is slightly narrower, the tail end is provided with threads that can match the other side wall of the cavity, and a through hole is provided in the middle section.
  • the adjusting rod 1346 can be rotated counterclockwise or clockwise by inserting a tool into the horizontal slot.
  • the steering wire 1221 can be wound through the through hole of the adjusting rod 1346, or can be wound directly without passing through the through hole.
  • the effective length of the upper steering wire 1221a is shortened, and the effective length of the lower steering wire 1221b is lengthened.
  • the effective length is exactly the opposite, that is, the upper side
  • the effective length of the turning wire 1221a is lengthened, and the effective length of the lower turning wire 1221b is shortened.
  • zoom adjustment methods increase the flexibility of use and can be selected according to actual needs.
  • the steering wire 1221 includes an upper steering wire 1221a, an adjustment steering wire 1221c and a lower steering wire 1221b in sequence, and the three are continuous; the second push button seat 1342 is provided with a second scaling structure of the steering wire.
  • the second scaling structure of the steering wire is suitable for bidirectionally adjusting the upper steering wire 1221a and the lower steering wire by bidirectionally scaling the length of the adjusting steering wire 1221c.
  • the adjusting steering wire 1221c is a reserved section located between the upper steering wire 1221a and the lower steering wire 1221b, and is used to adjust the effective length of both sides thereof, thereby increasing the flexibility of use.
  • the second scaling structure of the steering wire includes an adjustment channel, a left adjuster 1347 and a right adjuster 1348.
  • the adjustment channel is a cavity and extends along The lower cover 32 extends in the length direction, and the left adjuster 1347 and the right adjuster 1348 are respectively perpendicular to the extension direction of the adjustment channel and penetrate one side wall of the cavity from outside to inside, and are installed to be rotatable in both directions.
  • through holes are opened radially in the middle sections of the left adjuster 1347 and the right adjuster 1348; the adjustment channel is used as a passage and effective length scaling channel for the steering wire 1221.
  • the steering wire 1221 is directly wound around the left adjuster 1347 and the right adjuster 1348 for a certain number of turns respectively or passes through each of the through holes and then wound around the left adjuster 1347 and the right adjuster 1348 for a certain number of turns respectively.
  • the entire steering wire 1221 is divided into three sections through two adjusters, namely, the upper steering wire 1221a and the lower steering wire 1221b that respectively control the bending direction of the pliers 11, and the upper steering wire 1221b located between the two adjusters.
  • the adjustment between the steering wire 1221c The left adjuster 1347 can adjust the effective length of the upper steering wire 1221a, and the right adjuster 1348 can adjust the effective length of the lower steering wire 1221b.
  • the steering wire 221 therein is in a locked (see Figure 12(c)) or relaxed (see Figure 12(b)) state.
  • the tightness of the upper steering wire 1221a can be adjusted.
  • the length of the lower steering wire 1221b and selecting the adjuster to be in the closed state the tightness of the lower steering wire 1221b can be adjusted.
  • the tightness of the steering wire of the entire system can be adjusted.
  • the intensity of operating the bending push button assembly 134 is also changed, thereby changing the curvature of the associated part.
  • the handle 13 includes an upper cover 131, and a plurality of slots 1311 are provided on the inner top surface of the upper cover 131; the second block 1343 has at least one first Two protrusions 13431 are adapted to be inserted into the slot 1311 to fix the position of the second push button seat 1342.
  • the movement distance of the second push button 1341 in the previous embodiment is locked through the cooperation between the second protrusion 13431 and the slot 1311, that is, the bending angle of the first sheath 12 is locked.
  • the plurality of card slots 1311 are arranged at equal intervals, and the size of the interval is related to the adjustment accuracy of the bending angle. The smaller the interval, the higher the adjustment accuracy.
  • the upper cover 131 is provided with a chute 1313
  • the second push button 1341 extends out of the upper cover 131 through the chute 1313 and is adapted to move along the The chute 1313 moves back and forth.
  • the chute 1313 provides space for the second push button 1341 to move left and right.
  • the movable distance of the second push button 1341 can be changed by changing the length of the chute 1313, thus setting the first The bendable angle of the sheath 12.
  • the length of the chute 1313 is generally the same as the total arrangement length of the plurality of card slots 1311 .
  • the upper cover 131 is provided with a guide groove 1312 , and the guide groove 1312 is suitable for receiving and guiding the steering wire 1221 .
  • the guide groove 1312 limits the position and movement trajectory of the steering wire 1221, which can prevent the steering wire 1221 from positional deviation under stress and during movement, thereby affecting the accuracy of the bending angle control.
  • the outer top surface of the upper cover 131 can be covered with soft glue to prevent foreign matter from entering and affecting the control.
  • a guide sleeve is provided in the guide groove 1312 .
  • the guide sleeve can reduce the frictional resistance of the steering wire 1221.
  • the material of the guide sleeve can be made of polymer materials with high lubrication properties.
  • the mouth of the receiving cavity of the second push button seat 1342 has a second limiting portion 13421 extending inward.
  • the second limiting portion 13421 can effectively prevent the second blocking block 1343 from protruding from the second push button seat 1342.
  • the clamp head opening and closing control mechanism includes a clamping push button assembly 133 provided at the front of the lower cover 132 of the handle 13 .
  • the button assembly 133 includes a first push button seat 1332.
  • the first push button seat 1332 is provided with a pulling wire fixing interface c, and the pulling wire 127 is fixed to the pulling wire fixing interface c; the first push button seat 1332 is slidably provided on the inner bottom surface of the lower cover 132.
  • a first spring 1334 is accommodated in the first push button seat 1332.
  • a first blocking block 1333 is provided on the top surface of the first spring 1334.
  • the blocking block 1333 has a first screw 1335 with its head facing upward, and a first push button 1331 is screwed on the first screw 1335 .
  • the pulling wire 127 is fixed on the pulling wire fixing interface c, that is, there is no relative movement between the two. Pushing the first push button 1331 to the left or right causes the first push button base 1332 to slide to the left or right, causing the pulling wire 127 to receive a pulling force to the left or right. Specifically, if the first push button 1331 is pushed to the left (that is, in the direction of approaching the pliers 11 , or moved forward), the pulling wire 127 is pushed to the left, and the pliers 11 connected to the pulling wire 127 are pushed And open.
  • Both the first push button 1331 and the second push button 1341 can be operated independently without interfering with each other, and can be used for one-handed operation.
  • the first clamping block 1333 has at least one first protrusion 13331, and the first protrusion 13331 is adapted to be inserted into a plurality of slots 1311 on the upper cover 131 of the handle 13 to fix it.
  • the locking of the moving distance of the first push button 1331 in the previous embodiment is achieved through the cooperation of the first protrusion 13331 and the slot 1311, that is, the open or closed state of the pliers 11 is locked.
  • the size of the opening is locked, and the degree of closure is locked when closed, that is, the size of the remaining opening, collectively called the opening and closing degree.
  • the plurality of slots 1311 are arranged at equal intervals, and the size of the intervals is related to the adjustment accuracy of the opening and closing of the pliers 11 .
  • the mouth of the receiving cavity of the first push button seat 1332 has a first limiting portion 13321 extending inward.
  • the first limiting portion 13321 can effectively prevent the first blocking block 1333 from protruding from the first push button seat 1332.
  • the handle 13 includes a stress diffusion tube 136 that is docked with the first sheath 12 .
  • the stress diffusion tube 136 can disperse the stress between the first sheath 12 and the handle 13, effectively preventing the first sheath 12 from deforming at the connection location.
  • An embodiment of the auxiliary traction method for endoscopic surgery of the present invention includes the following steps: (1) inserting the lens of the endoscope A into the second through channel 212 provided on the tip cap 21 of the tip cap catheter 2; (2) ) Send the tip cap 21 and a part of the second sheath 22 of the tip cap catheter 2 into the target affected area together with the endoscope A; (3) Deflect the lens of the endoscope A, and the second flexible sheath 22 of the second sheath 22 Section 221 is bent accordingly until the lens of endoscope A finds the target tissue; (4) Extend the clamp head 11 of the traction forceps 1 into the opening provided on the joint 23 of the tip cap catheter 2, and pass it through the second sheath 22 Enter the first through channel 211 provided on the tip cap 21 until the forceps head 11 is seen under the lens of the endoscope A; (5) Adjust the first sheath 12 of the traction forceps 1 by operating the handle 13 of the traction forceps 1 And the curvature and/or bending direction of the second
  • the specific operation may be as follows:
  • the outer snake bone 122 is pulled by the steering wire 1221b and deforms downward, and the inner snake bone 123 is deformed downward by the outer snake bone 123. 122 is deformed and squeezed, and bending deformation occurs in the same direction as the outer snake bone 123.
  • the operator releases the second push button 1341, and the second spring 1344 built in the second push button seat 1342 rebounds, pushing the second blocking block 1343 upwards back into the corresponding slot 1311.
  • the second clamping block 1343 cooperates with the clamping groove 1331 to fix the bending push button assembly 134, thereby fixing the position of the steering wire 1221b relative to the outer snake bone 122, and locking and maintaining the bending angle unchanged.
  • the upper steering wire 1221a tightens
  • the lower steering wire 1221b relaxes
  • the outer snake bone 122 moves toward the tightened steering wire.
  • direction that is, upward bending deformation occurs
  • the inner snake bone 123 is deformed and squeezed by the outer snake bone 122, and bending deformation occurs in the same direction as the outer snake bone 123.
  • the operator releases the second push button 1341, and the second spring 1344 built in the second push button seat 1342 rebounds, pushing the second blocking block 1343 upwards back into the corresponding slot 1311.
  • the second clamping block 1343 cooperates with the clamping groove 1331 to fix the bending push button assembly 134, thereby fixing the position of the steering wire 1221 relative to the outer snake bone 122, and locking and maintaining the bending angle unchanged.
  • the clamping push button assembly 133 is fixed, thereby fixing the position of the pulling wire 127 relative to the pliers 11, and the locking keeps the closed position of the pliers 11 unchanged, that is, the size of the remaining opening remains unchanged.
  • the outer snake bone 122 is in a bent state, when the pliers 11 are closed and the pulling wire 127 is pulled in a direction away from the pliers, the pulling wire 127 will be close to the inner wall of the inner snake bone 123.
  • the locking structure enables the inner snake bone to support the traction wire 127, thereby avoiding affecting the bending state of the outer snake bone 122, and solving the problem of mutual interference between the opening and closing and bending angles of the pliers 11.

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Abstract

一种内窥镜手术辅助牵引系统及方法，系统包括牵引钳(1)和先端帽导管(2)，先端帽导管(2)适于分别为内窥镜(A)及牵引钳(1)提供独立的器械贯通通道；先端帽导管(2)具有第二可弯曲段(221)，第二可弯曲段(221)的长度完全覆盖内窥镜(A)的可弯曲部分；牵引钳(1)具有第一可弯曲段，第一可弯曲段适于双向弯曲并锁定保持弯曲角度，牵引钳(1)的钳头(11)适于开合并锁定保持开合状态。先端帽导管(2)上与内窥镜(A)的弯曲部分相邻近对应的部分也为可弯曲部，且可弯曲部内腔中容纳的牵引钳(1)的鞘管也是可弯曲的，使得先端帽导管(2)所充当的外接通道可以随着内窥镜(A)一同弯曲，增加了随动性，减少了需要的操作空间。

Description

一种内窥镜手术辅助牵引系统及方法 技术领域
本发明涉及医疗器械技术领域，具体涉及一种内窥镜手术辅助牵引系统及方法，用于内窥镜下手术辅助牵拉黏膜组织。
背景技术
病变黏膜下组织的剥离是内窥镜下黏膜剥离术(ESD，Endoscopic submucosal dissection)操作过程的核心部分，而黏膜与黏膜下组织之间术野的显露是手术安全、顺利进行的关键。为了使ESD手术可以更加顺利地进行，人们发明了一些方法来辅助ESD操作，即辅助牵引技术，“组织夹牵拉法”就是其中的一种。
目前已知的几种组织钳钳夹牵拉方法，都是应用不同的路径将组织钳伸进消化道内，在完成四周预切开后，应用组织钳将需要剥离的黏膜层夹紧并提起牵拉，充分暴露需要剥离的黏膜下层，组织钳起到充当操作者另一只辅助手的作用，将需要剥离的病变黏膜层提起。不同操作者选用的组织钳进入消化道的方法不同，有采用双通道内镜的，使组织钳通过其中一个内镜通道；也有采用单通道内镜的，器械通道中的组织钳伸出镜头抓着另一把组织钳随同内镜一起进入消化道，再撤出内镜通道中的组织钳的方法；还有采用内镜外接通道的，组织钳通过外接通道进入消化道的方法。这些方案各有各的优缺点，如“双通道”优点是可以在镜下直视操作，且对于大面积治疗有利，缺点是双通道的体积过大，患者要承受更多痛苦。而利用一把组织钳夹持另一把进入人体的方法，虽然实际不会占用器械通道，但在进入人体过程中会发生损伤人体的风险，且组织钳进入消化道后，由于与内镜之间没有连接，使得操作异常困难；而且将组织钳送入消化道的过程繁琐，不利于提高手术效率。现有最理想的方法应该是“外接通道”的方法，既保证了组织钳在进 入消化道后与内镜保持一定连接，有利于操控，又额外提供了器械通道，且在组织钳进入人体时还可提供保护。但是现有的方案中，外接通道并没有考虑到与内镜连接后，通道对应内镜可弯曲部分的随动性，这就导致了在内窥镜头端主动弯曲时，外接通道不能很好地随着镜头一起弯曲，需要很大的操作空间才能准确定位。
中国专利文献CN214017647U公开了一种黏膜牵引装置和内窥系统，该黏膜牵引装置包括管体、第一夹子以及牵引件，第一夹子安装于管体的远端，牵引件设置有第一作用部和第二作用部，第一作用部作用于管体的远端，第二作用部用于作用于内窥镜的远端，在牵引件被牵引的情况下，管体的远端与内窥镜的远端相互靠近并保持固定，在牵引件被松开的情况下，管体的远端与内窥镜的远端可各自独立活动。该内窥系统包括前述的黏膜牵引装置。
中国专利文献CN102125459B公开了一种黏膜牵引器，包括：一能够安装在内窥镜远端头部的内镜固定部；一能够安装手术器械的器械抬举部；一摆臂，摆臂一端与内镜固定部活动连接，摆臂另一端与器械抬举部活动连接；一牵引部，牵引部的远端与器械抬举部连接。
以上两者，CN214017647U依靠金属夹子夹持病变组织，无法自主控制牵引角度，仅依靠内窥镜先端部偏转定位病灶；CN102125459B为通道依靠外力使抬举套偏转，实现方向控制，而非组织钳自身控制弯曲角度，同样无法准确控制牵引角度，且操作范围仅限于通道能到达的角度。
综上，现有牵引系统主要存在如下缺点：
1.不能精准控制组织钳准确到达病灶组织，一般由医师凭经验控制内窥镜偏转，或通过外力挤压外接通道定向变形这两种方式使组织钳到达病灶，准确度不佳，需要多次操作方能实现，效率低下。
2.在对病灶组织实施抓取、牵引过程中，组织钳弯曲角度不能自锁，需要操作者全程控制弯曲状态，操控难度大，工作强度大，影响手术效率。
3.外接通道并没有考虑到与内镜连接后，通道对应内镜可弯曲部分的随动性，这就导致了在内窥镜头端主动弯曲时，外接通道不能很好地随着镜头一起弯曲，导致需要的操作空间很大。
4.组织钳在抓取病灶组织时，需要完全将钳头伸出外接通道，对于距离镜头较近的病灶组织，需要移动镜头后再行抓取，适应性差。
发明内容
本发明的目的是为克服现有技术所存在的缺陷，提高组织钳相对于内窥镜的随动性能，增加组织钳操作状态的锁定功能，以实现精确定位至病灶并快速高效地进行镜下手术。
为实现上述发明目的，第一方面，本发明提供一种内窥镜手术辅助牵引系统，包括牵引钳和先端帽导管，所述先端帽导管适于分别为内窥镜及所述牵引钳提供独立的器械贯通通道；所述先端帽导管具有第二可弯曲段，所述第二可弯曲段的长度完全覆盖内窥镜的可弯曲部分；所述牵引钳具有第一可弯曲段，所述第一可弯曲段适于双向弯曲并锁定保持弯曲角度，所述牵引钳的钳头适于开合并锁定保持开合状态。
进一步地，所述先端帽导管包括依次连接的先端帽、第二鞘管和接头，所述接头用于为所述牵引钳进入所述第二鞘管提供开口；所述先端帽内具有至少两个并列设置的贯通通道，包括用于连接所述第二鞘管的第一贯通通道和用于安装内窥镜的第二贯通通道，使所述第二鞘管与内窥镜并列设置；所述第一贯通通道用于通过所述牵引钳，所述第二可弯曲段位于所述第二鞘管的远端。
进一步地，所述第二贯通通道中设有向内凸起的台阶，所述台阶用于阻挡内窥镜的镜头。
进一步地，所述第一贯通通道的起始端的一段和所述第二贯通通道的起始端的一段之间具有隔层，形成隔层段，所述第一贯通通道的末端的一段和所述第二贯通通道的末端的一段之间通过缺口相连通，形成缺口段，所述隔层段与缺口段相邻。
进一步地，所述缺口段的长度大于所述台阶与所述先端帽的远端面之间的距离。
进一步地，所述先端帽上在所述第一贯通通道的远端处为斜面。
进一步地，所述斜面的径向高度大于所述第一贯通通道的内径，且不超过所述先端帽的高度的1/2。
进一步地，所述第二可弯曲段上具有多个豁口。
进一步地，所述豁口贯通管壁。
进一步地，所述豁口的内壁设有软膜。
进一步地，多个所述豁口沿轴向延伸，并在径向按以下方式排布：在同一径向截面上，具有多个沿圆周间隔布设的多个豁口；或者，在同一径向截面上，仅有一个未布满圆周的豁口；或者，在同一径向截面上，仅有一个布满圆周的豁口；前两种径向排布方式中，相邻径向截面上的豁口的位置一致或交错。
进一步地，所述第二可弯曲段为单壁波纹管；所述单壁波纹管的外壁为：依次递进的环形结构；或者，单个螺旋结构；或者，多个螺旋结构。
进一步地，所述牵引钳包括依次连接的钳头、第一鞘管和手柄；所述第一鞘管具有所述第一可弯曲段，所述第一可弯曲段中容纳固定有转向丝和牵引丝；所述转向丝的一端连接至所述手柄的鞘管弯曲控制机构，所述鞘管弯曲机构适于通过双向牵拉所述转向丝实现所述第一鞘管的第一可弯曲段双向弯曲并锁定保持弯曲角度；所述牵引丝的一端连接至所述手柄的钳头开合控 制机构，另一端连接至所述钳头，所述钳头开合控制机构适于通过双向牵拉所述牵引丝实现所述钳头的开合并锁定保持开合状态。
进一步地，所述第一鞘管的第一可弯曲段为多层复合结构，由外向内依次为包管、外蛇骨、转向丝、蛇骨接管和内蛇骨；所述牵引丝容纳穿行于所述内蛇骨内；所述外蛇骨和内蛇骨均适于双向弯曲。
进一步地，所述外蛇骨适于双向各270°弯曲。
进一步地，所述内蛇骨适于双向各180°弯曲。
进一步地，所述外蛇骨、内蛇骨和蛇骨接管三者的轴向近端固定连接；所述内蛇骨在靠近所述钳头的一端保持自由活动状态。
进一步地，所述转向丝轴向布设于所述第一鞘管两侧，适于通过向逼近所述钳头方向或远离所述钳头方向牵拉其中一侧的转向丝使所述第一鞘管向不同侧弯曲。
进一步地，所述鞘管弯曲控制机构包括弯曲推钮组件和滚轮；所述弯曲推钮组件滑动设于所述手柄的下盖的中部，所述滚轮固定设于所述下盖的后部；所述转向丝经所述弯曲推钮组件固定后延伸至所述滚轮，并紧贴所述滚轮缠绕后折返。
进一步地，所述弯曲推钮组件包括第二推钮座，所述第二推钮座上设有转向丝固定接口，所述转向丝固定于所述转向丝固定接口；所述第二推钮座滑动设于所述下盖的内底面上，第二推钮座中容纳有第二弹簧，所述第二弹簧的顶面上设有第二卡块，所述第二卡块内置有头朝上的第二螺钉，所述第二螺钉上螺接有第二推钮。
进一步地，所述转向丝至少包括上侧转向丝和下侧转向丝，所述上侧转向丝和所述下侧转向丝之间相分离或相连续。
进一步地，当所述上侧转向丝和所述下侧转向丝之间相连续时，所述第二推钮座上设有转向丝第一缩放结构，所述转向丝第一缩放结构适于同时调整所述上侧转向丝和所述下侧转向丝的有效长度。
进一步地，所述转向丝第一缩放结构包括调节通道和调节杆，所述调节通道为空腔并沿所述下盖的长度方向延伸，所述调节杆垂直于所述调节通道的延伸方向从外向内贯穿所述空腔的一侧腔壁后可双向转动地安装于另一侧腔壁上，所述调节杆的中段径向开设有通孔；所述调节通道用作所述转向丝的穿行和有效长度缩放通道，所述转向丝直接缠绕所述调节杆一定圈数或穿过所述通孔后再缠绕所述调节杆一定圈数。
进一步地，所述转向丝依次包括上侧转向丝、调节转向丝和下侧转向丝，三者之间相连续；所述第二推钮座上设有转向丝第二缩放结构，所述转向丝第二缩放结构适于通过双向缩放所述调节转向丝的长度来分别双向调整所述上侧转向丝和所述下侧转向丝的有效长度。
进一步地，所述转向丝第二缩放结构包括调节通道、左调节器和右调节器，所述调节通道为空腔并沿所述下盖的长度方向延伸，所述左调节器和右调节器分别垂直于所述调节通道的延伸方向从外向内贯穿所述空腔的一侧腔壁后可双向转动地安装于另一侧腔壁上，所述左调节器和右调节器的中段均径向开设有通孔；所述调节通道用作所述转向丝的穿行和有效长度缩放通道，所述转向丝直接分别缠绕所述左调节器和右调节器一定圈数或穿过各所述通孔后再分别缠绕所述左调节器和右调节器一定圈数。
进一步地，所述手柄包括上盖，所述上盖的内顶面上设有若干卡槽；所述第二卡块上具有至少一个第二凸起，所述第二凸起适于嵌入所述卡槽以固定所述第二推钮座的位置。
进一步地，所述上盖上设有滑槽，所述第二推钮经由所述滑槽伸出所述上盖，并适于沿所述滑槽来回移动。
进一步地，所述上盖上设有导向槽，所述导向槽适于容纳所述转向丝并为其导向。
进一步地，所述导向槽内设有导向套管。
进一步地，所述第二推钮座的容纳腔口部具有向内延伸的第二限位部。
进一步地，所述钳头开合控制机构包括设于所述手柄的下盖的前部的夹持推钮组件，所述夹持推钮组件包括第一推钮座，所述第一推钮座上设有牵引丝固定接口，所述牵引丝固定于所述牵引丝固定接口；所述第一推钮座滑动设于所述下盖的内底面上，第一推钮座中容纳有第一弹簧，所述第一弹簧的顶面上设有第一卡块，所述第一卡块内置有头朝上的第一螺钉，所述第一螺钉上螺接有第一推钮。
进一步地，所述第一卡块上具有至少一个第一凸起，所述第一凸起适于嵌入所述手柄的上盖上的若干卡槽，以固定所述第一推钮座的位置。
进一步地，所述第一推钮座的容纳腔口部具有向内延伸的第一限位部。
进一步地，所述手柄包括应力扩散管，所述应力扩散管与所述第一鞘管对接。
第二方面，本发明提供一种内窥镜手术辅助牵引方法，包括如下步骤：将内窥镜的镜头套入先端帽导管的先端帽上设置的第二贯通通道中；将先端帽及先端帽导管的第二鞘管的一部分与内窥镜一同送入目标患处；偏转内窥镜的镜头，第二鞘管的第二可弯曲段随之弯曲，直至内窥镜的镜头找寻到目标组织；将牵引钳的钳头伸入先端帽导管的接头上设置的开口中，并经第二鞘管进入先端帽上设置的第一贯通通道，直至在内窥镜的镜头下看到钳头；通过操控牵引钳的手柄调节牵引钳的第一鞘管及先端帽导管的第二鞘管的弯曲度和/或弯曲方向；通过操控牵引钳的手柄调节牵引钳的钳头打开或闭合。
与现有技术相比，本发明的有益效果在于：
1.牵引钳前端可实现双向180°弯曲以及管身360°扭转，拥有更大的操作角度，可覆盖更大的操作范围，减少操作次数，提高效率。
2.牵引钳前端弯曲到适当位置时，松开手柄上对应的推钮，可锁定牵引钳前端的弯曲角度，此时不再需要操作者持续控制也能保持该弯曲角度，降低了操作难度和工作强度。
3.先端帽导管上与内窥镜的弯曲部分相邻近对应的部分也为可弯曲部，且该可弯曲部内腔中容纳的牵引钳的鞘管也是可弯曲的，使得先端帽导管所充当的外接通道可以随着内窥镜一同弯曲，增加了随动性，减少了需要的操作空间。
4.先端帽导管上设置的可弯曲段和牵引钳的可弯曲段互相配合，牵引钳的可弯曲段位于先端帽导管的可弯曲段的内腔中，从而使得钳头不需要完全伸出先端帽，对于抓取距离内窥镜的镜头较近的组织，或是将远处组织抓取至距离镜头近端再行切割提供了便利。
附图说明
图1为本发明系统一个实施例的结构示意图；
图2为本发明系统一个实施例中牵引钳的结构示意图；
图3为本发明系统一个实施例中先端帽导管的结构示意图；
图4为本发明系统一个实施例中先端帽的结构示意图；
图5为本发明系统一个实施例中下盖的结构示意图(含鞘管弯曲机构及钳头开合控制机构)；
图6为本发明系统一个实施例中钳头开合控制机构的夹持推钮组件的结构示意图；
图7为本发明系统一个实施例中鞘管弯曲机构的弯曲推钮组件的结构示意图；
图8为本发明系统一个实施例中上盖的结构示意图；
图9为本发明系统一个实施例中第一鞘管的结构示意图(剖面)；
图10为本发明系统一个实施例的使用状态图；
图11为本发明系统一个实施例中转向丝第一缩放结构的示意图；
图12为本发明系统一个实施例中转向丝第二缩放结构的示意图；
图13为现有技术中先端帽的剖面图；
图14为本发明系统一个实施例中先端帽的剖面图；
图15为本发明系统一个实施例中先端帽的使用状态图。
图中：
1-牵引钳；11-钳头；12-第一鞘管；121-包管；122-外蛇骨；1221-转向丝；1221a-上侧转向丝；1221b-下侧转向丝；1221c-调节段转向丝；123-内蛇骨；124-蛇骨接管；125-外鞘管；126-内管；127-牵引丝；13-手柄；131-上盖；1311-卡槽；1312-导向槽；1313-滑槽；132-下盖；133-夹持推钮组件；1331-第一推钮；1332-第一推钮座；13321-第一限位部；1333-第一卡块；13331-第一凸起；1334-第一弹簧；1335-第一螺钉；134-弯曲推钮组件；1341-第二推钮；1342-第二推钮座；13421-第二限位部；1343-第二卡块；13431-第二凸起；1344-第二弹簧；1345-第二螺钉；1346-调节杆；1347-左调节器；1348-右调节器；135-滚轮；136-应力扩散管；
2-先端帽导管；21-先端帽；211-第一贯通通道；212-第二贯通通道；2121-台阶；213-缺口；214-斜面；215-隔层；22-第二鞘管；221-第二可弯曲段；2211-豁口；23-接头；
A-内窥镜。
具体实施方式
以下结合附图通过特定的具体实例说明本发明的实施方式，本领域技术人员可由本说明书所揭露的内容轻易地了解本发明的其他优点与功效。本发明还可以通过另外不同的具体实施方式加以实施或应用，本说明书中的各项细节也可以基于不同观点与应用，在没有背离本发明的精神下进行各种修饰或改变。
需要说明的是，本文中提及的方位词，如上、下、左、右、前、中、后、底、顶、内、外等，均是指图中所示的方位。这是为了描述方便，并不作为对本发明的任何限定。
如图1-图10所示，本发明内窥镜手术辅助牵引系统的一个实施例，包括牵引钳1和先端帽导管2，所述先端帽导管2适于分别为内窥镜A及所述牵引钳1提供独立的器械贯通通道；所述先端帽导管2具有第二可弯曲段221，所述第二可弯曲段221的长度完全覆盖内窥镜A的可弯曲部分；所述牵引钳1具有第一可弯曲段，所述第一可弯曲段适于双向弯曲并锁定保持弯曲角度，所述牵引钳1的钳头11适于开合并锁定保持开合状态。
本实施例中，内窥镜A的可弯曲部分和先端帽导管的第二可弯曲段221二者的位置相重叠且绑定为一体，内窥镜A的可弯曲部分与先端帽导管的第二可弯曲段221并排相邻，只要内窥镜A的可弯曲部分进行弯曲动作，则先端帽导管的第二可弯曲段221必然随着进行弯曲，随动性好，可有效减小操作半径。
在一个实施例中，所述先端帽导管2包括依次连接的先端帽21、第二鞘管22和接头23，所述接头23用于为所述牵引钳1进入所述第二鞘管22提供开口；所述先端帽21内具有至少两个并列设置的贯通通道，包括用于连接所述第二鞘管22的第一贯通通道211和用于安装内窥镜A的第二贯通通道212，使所述第二鞘管22与内窥镜A并列设置；所述第一贯通通道211用于通过所述牵引钳1，所述第二可弯曲段221位于所述第二鞘管22的远端。本实施例 中，先端帽21设计为双通道结构，除了供安装内窥镜A的第二贯通通道212，额外提供了第一贯通通道211，其可以作为牵引钳1的器械通道，为更好地辅助牵引创造了条件。先端帽21的材质可选用硅橡胶、热塑性聚氨酯弹性体等具有一定弹性的软性高分子材质，在一定范围内可以拉伸，可以配合不同规格的内窥镜头，同时软性材质可保证患者体内组织不被损伤。先端帽21上连接的第二鞘管22可以随先端帽21固定于内窥镜A上，为内窥镜A增加一个通道，方便进行内镜下多器械的协同手术操作。
在一个实施例中，所述第二贯通通道212中设有向内凸起的台阶2121，所述台阶2121用于阻挡内窥镜A的镜头。本实施例中，台阶2121相当于内窥镜A的镜头在第二贯通通道212中伸入深度的调节器，可根据实际需要设置台阶2121在第二贯通通道212中的轴向位置，如对不同的患者，根据先期的影像信息可初步判断病灶的位置，据此选择合适的台阶2121的位置，即选择不同规格的先端帽21。
在一个实施例中，如图14-图15所示，所述第一贯通通道211的起始端的一段和所述第二贯通通道212的起始端的一段之间具有隔层215，形成隔层段，所述第一贯通通道211的末端的一段和所述第二贯通通道212的末端的一段之间通过缺口213相连通，形成缺口段，所述隔层段与缺口段相邻。本实施例中，医师操作牵引钳1向下弯曲时，牵引钳1的弯曲部分向下经过缺口213，容纳了部分牵引钳1的弯曲段，相对于图13所示的现有结构(两个通道之间无缺口，全程都是隔层)，使得牵引钳1的钳头11距离内窥镜A的器械通道更近，则通过内窥镜A的器械通道中的手术工具切割牵引钳1的钳头11所抓取的病变组织时更为便利。先端帽21上设置的缺口213与牵引钳1相配合，使得牵引钳1的钳头11上弯曲的一部分处于先端帽21中，拉近了钳头11与内窥镜A的镜头的距离，可在更狭小的空间内操作。
在一个实施例中，所述缺口段的长度大于所述台阶2121与所述先端帽21 的远端面之间的距离。本实施例中，保证了所述缺口213开口位置在内窥镜镜头之后，对可弯曲抓钳等器械有更好的适应性。
在一个实施例中，如图14-图15所示，所述先端帽21上在所述第一贯通通道211的远端处为斜面214。本实施例中，斜面214位于先端帽21上与人体黏膜直接接触的位置，可改变对黏膜的施力方向，增大施力面积，使得先端帽导管2在随内窥镜A进入人体时能更为轻松地分开黏膜，避免对人体组织产生伤害，解决了目前先端帽前端太平坦从而不易无损伤地分开黏膜的问题。同时，如图15所示，相对于图13所示的现有结构(无斜面，牵引钳B向上弯曲时在通道出口处的活动范围小)，医师操作牵引钳1向上弯曲时在第一贯通通道211的出口处的活动范围大，则钳头11可及的活动范围更大，更有利于快速找到并抓取病变组织。
在一个实施例中，所述斜面214的径向高度大于所述第一贯通通道211的内径，且不超过所述先端帽21的高度的1/2。本实施例中，所述斜面214的高度大于所述第一贯通通道211的内径，使得所述斜面214与所述缺口213形成的“尖头”位置在径向高度上低于所述第一贯通通道211与所述第二贯通通道212之间的“隔断”，便于可弯曲抓钳等器械弯曲活动。所述斜面214径向高度大于所述先端帽1径向高度的1/2时，虽然能分开组织，但是此类锐角可能不利于器械进出及操作，还可能影响视野。
在一个实施例中，所述第二可弯曲段221上具有多个豁口2211。本实施例中，多豁口结构可增强第二可弯曲段221的柔性，使其更容易弯曲，随动性更好。
在一个实施例中，所述豁口2211贯通管壁。本实施例中，贯通后豁口形变量大，在弯曲过程中，贯通状态的豁口2211相对于未贯通的阻力更小，即更容易弯曲，随动性更好。
在一个实施例中，所述豁口2211的内壁设有软膜。本实施例中，牵引钳 1在先端帽导管2的内腔中移动时，有可能伸到贯通状态的豁口2211的外侧，即跑偏到先端帽导管2内腔的外侧，导致牵引钳1穿行失败。为了保证牵引钳1始终在先端帽导管2的内腔中移动，在每个豁口2211的内壁设有软膜来遮盖贯通的通孔，此时软膜实质起到了导向作用，即能有效保证牵引钳1在先端帽导管2的内腔中顺畅穿行。软膜在管体内部将豁口覆盖，外侧豁口依然存在。贯通状态下更易加工，但是器械通过性不佳。此时给管壁内侧安装软膜，相当于一整根完整的管子，导向性更好，等于优化了器械的通过性，相比于非贯通状态，弯曲性能更佳。非贯通管壁由于是一个整体，材质相对于软膜偏硬，对豁口弯曲时的拉拽更强，弯曲性不如软膜。
在一个实施例中，多个所述豁口2211沿轴向延伸，并在径向按以下方式排布：在同一径向截面上，具有多个沿圆周间隔布设的多个豁口2211；或者，在同一径向截面上，仅有一个未布满圆周的豁口2211；或者，在同一径向截面上，仅有一个布满圆周的豁口2211；前两种径向排布方式中，相邻径向截面上的豁口2211的位置一致或交错。本实施例中，第一种径向排布方式是在同一个圆周上间隔相同或不同的角度布设多个豁口2211，这样可使其能容易地向多个方向弯曲，即具有多向或全向随动性能；第二种径向排布方式在同一个圆周上只设置一个豁口2211，可以仅在需要弯曲的方向上设置该豁口2211，这样可以容易地向豁口2211所在的方向弯曲，也容易向豁口2211相对的方向弯曲；第三种径向排布方式相当于在第一种方式的基础上，将多个间隔布设的豁口2211连为一个连续的豁口，具有更好的全向随动性。
在一个实施例中，所述第二可弯曲段221为单壁波纹管；所述单壁波纹管的外壁为：依次递进的环形结构；或者，单个螺旋结构；或者，多个螺旋结构。本实施例中，单壁波纹管相当于在其外壁上设置了连续的豁口，具有较好的随动性。
在一个实施例中，所述牵引钳1包括依次连接的钳头11、第一鞘管12和 手柄13；所述第一鞘管12具有所述第一可弯曲段，所述第一可弯曲段中容纳固定有转向丝1221和牵引丝127；所述转向丝1221的一端连接至所述手柄13的鞘管弯曲控制机构，所述鞘管弯曲机构适于通过双向牵拉所述转向丝1221实现所述第一鞘管12的第一可弯曲段双向弯曲并锁定保持弯曲角度；所述牵引丝127的一端连接至所述手柄13的钳头开合控制机构，另一端连接至所述钳头11，所述钳头开合控制机构适于通过双向牵拉所述牵引丝127实现所述钳头11的开合并锁定保持开合状态。本实施例中，牵引钳1的手柄13中设置鞘管弯曲控制机构来控制第一鞘管12的第一可弯曲段的弯曲角度和弯曲方向，可根据需要向某一个方向弯曲，并调节至合适的弯曲角度，调节到位后可锁定保持在该弯曲角度，不再需要人工始终握持某一个部位来保持弯曲角度，省时省力，方便快捷；同理，牵引钳1的手柄13中设置钳头开合控制机构来控制钳头11的打开或闭合，并能将打开或闭合状态进行锁定，即，如果是闭合状态，则会一直保持闭合，如果是打开状态，则保持开口大小不变，不需要人工进行维持。手柄13的鞘管弯曲控制机构侧可设置双向弯曲角度标识，使弯曲角度的控制更明确。
在一个实施例中，所述第一鞘管12的第一可弯曲段为多层复合结构，由外向内依次为包管121、外蛇骨122、转向丝1221、蛇骨接管124和内蛇骨123；所述牵引丝127容纳穿行于所述内蛇骨123内；所述外蛇骨122和内蛇骨123均适于双向弯曲。本实施例中，蛇骨接管124在近端连接内蛇骨123和外蛇骨122，并使得外蛇骨122上设置的转向丝1221可以通过内蛇骨123和外蛇骨122之间的间隙。外蛇骨122及内蛇骨123的材质可选用不锈钢、镍钛合金或其他金属材质。牵引丝127可以外套减少摩擦力的管材，材质为PTFE或其他高分子材质。如图9所示，第一鞘管12还包括普通段，普通段包括外鞘管125和内管126。内管126与外蛇骨122连接，内管126的形态为柔性蛇骨或弹簧管，材质为不锈钢、NiTi合金或其他金属材质。包管121包覆 在外蛇骨122外侧，外鞘管125包覆在内管126外侧，外鞘管125的材质采用较高润滑性质的高分子材料，包管121的材质采用高弹性的高分子材料。本实施例中，在外蛇骨122弯曲状态下，操作钳头11闭合时，向远离钳头11的方向拉动牵引丝127，会使得牵引丝127紧贴于内蛇骨123的内壁，此时由于内蛇骨123上设置的卡止结构(图上未示出，属于现有技术)，使得内蛇骨123对牵引丝127产生支撑，从而避免影响外蛇骨122的弯曲状态，解决了钳头11的开合与弯曲角度互相干扰的问题。牵引钳1的先端采用蛇骨结构，可很容易实现头部的双向180°弯曲。内蛇骨123可有效减小钳头11开合时牵引丝127对外蛇骨122的作用力所引起的形变或操控干扰。
在一个实施例中，所述外蛇骨122适于双向各270°弯曲。本实施例中，外蛇骨122可以向两个相对的方向分别能最大弯曲270°，外蛇骨122是直接与内窥镜A的可弯曲部分相邻或接触的，其可弯曲角度大必然使整个第一鞘管12的随动性更好。
在一个实施例中，所述内蛇骨123适于双向各180°弯曲。本实施例中，内蛇骨123可以向两个相对的方向分别能最大弯曲180°，这样能与外蛇骨122更好地匹配，提升整个第一鞘管12的随动性。
在一个实施例中，所述外蛇骨122、内蛇骨123和蛇骨接管124三者的轴向近端固定连接；所述内蛇骨123在靠近所述钳头11的一端保持自由活动状态。本实施例中，外蛇骨122和内蛇骨123的近端(靠近手柄13的一端，也称为后端)依靠蛇骨接管124连接，远端(远离手柄13的一端，也称为前端)的外蛇骨122及内蛇骨123之间可相对活动，在外蛇骨122受力弯曲时，带动内蛇骨123弯曲，由于近端固定，内蛇骨123的弯曲角度小于外蛇骨122的弯曲角度，则内蛇骨123的前端相对于外蛇骨122前伸，内蛇骨123与钳头11的内侧底部之间留有5mm以内的空隙，此处预留空隙在弯曲时被前伸的内蛇骨123填补。
在一个实施例中，所述转向丝1221轴向布设于所述第一鞘管12两侧，适于通过向逼近所述钳头11方向或远离所述钳头11方向牵拉其中一侧的转向丝1221使所述第一鞘管12向不同侧弯曲。本实施例中，转向丝1221是一根连续的整体并布设于第一鞘管12的两侧，可通过对某一侧的转向丝1221施加不同方向的外力实现第一鞘管12向不同侧弯曲。需要注意的是，转向丝221仅仅头端与外蛇骨22的前端连接，转向丝221穿行在外蛇骨22内壁所设置的一个个凸起孔中，拉动转向丝221时，转向丝221相对于外蛇骨22有一定滑动。在此过程中，外蛇骨22中的转向丝221的长度变短了，外蛇骨22就会被拉弯。需要说明的是，这种弯曲的目的是在内窥镜A已经弯曲到适当位置后的位置微调，以使钳头11更精准地靠近需要切除的组织。
在一个实施例中，所述鞘管弯曲控制机构包括弯曲推钮组件134和滚轮135；所述弯曲推钮组件134滑动设于所述手柄13的下盖132的中部，所述滚轮135固定设于所述下盖132的后部；所述转向丝1221经所述弯曲推钮组件134固定后延伸至所述滚轮135，并紧贴所述滚轮135缠绕后折返。本实施例中，转向丝1221通过滚轮135导向折返后分设于下盖132的两侧，正好与上一实施例中转向丝1221分设于第一鞘管12的两侧相对应；转向丝1221固定在弯曲推钮组件134上，随着弯曲推钮组件134移动，转向丝1221必然受到拉拽，如图5所示，弯曲推钮组件134可向左移动，也可向右移动，移动方向不同则转向丝1221的受力方向就不同，最终使第一鞘管12内的转向丝1221带动第一鞘管12向不同侧弯曲。
在一个实施例中，如图5和图7所示，所述弯曲推钮组件134包括第二推钮座1342，所述第二推钮座1342上设有转向丝固定接口，所述转向丝1221固定于所述转向丝固定接口；所述第二推钮座1342滑动设于所述下盖132的内底面上，第二推钮座1342中容纳有第二弹簧1344，所述第二弹簧1344的顶面上设有第二卡块1343，所述第二卡块1343内置有头朝上的第二螺钉 1345，所述第二螺钉1345上螺接有第二推钮1341。本实施例中，第二推钮座1342上设有两个转向丝固定接口a和b，转向丝1221从接口a进接口b出，转向丝1221是固定在第二推钮座1342上的，即二者之间没有相对运动。从图5可见，接口a、b所在位置，即左侧的转向丝1221位置是明显高于右侧的转向丝1221的，则图5中左侧的转向丝1221延伸后位于第一鞘管12内的上侧，图5中右侧的转向丝1221延伸后位于第一鞘管12内的下侧。向左或向右推动第二推钮1341，即可使第二推钮座1342向左或向右滑动，使图5中左侧的转向丝1221受到向左或向右的拉力。具体来说，如向左推动第二推钮1341(即向逼近钳头11的方向，或称为前移)，则图5中左侧的转向丝1221a上在接口b的右侧部分受到向左的拉力，经滚轮135缠绕折返后的右侧的转向丝1221b受到向右的拉力，则第一鞘管12内下侧的转向丝1221b受到向右的拉力，外蛇骨122受下侧转向丝1221b向右的拉拽，向下发生弯曲形变，内蛇骨123受外蛇骨122的变形挤压，发生与外蛇骨123同方向的弯曲形变。反之，如向右推动第二推钮1341(即向远离钳头11的方向，或称为后移)，则图5中左侧的转向丝1221a上在接口a的左侧部分受到向右的拉力，则第一鞘管12内上侧的转向丝1221a受到向右的拉力，外蛇骨122受上侧转向丝1221a向右的拉拽，向上发生弯曲形变，内蛇骨123受外蛇骨122的变形挤压，发生与外蛇骨123同方向的弯曲形变。本实施例中，通过滚轮135的缠绕折返改变施力方向，巧妙地实现了第一鞘管12的双向弯曲，弯曲的角度与第二推钮1341的移动距离相关，可根据实际需要确定。滚轮135将转向丝1221与第二推钮1341联系起来，同步性更好，完成一侧转向丝收紧的同时另一侧转向丝放松。
在一个实施例中，如图5所示，所述转向丝1221至少包括上侧转向丝1221a和下侧转向丝1221b，所述上侧转向丝1221a和所述下侧转向丝1221b之间相分离或相连续。本实施例中，如上侧转向丝1221a和所述下侧转向丝 1221b之间相分离，即二者之间是断开的，上侧转向丝1221a的其中一端止于转向丝固定接口a，下侧转向丝1221b的其中一端止于转向丝固定接口b。如上侧转向丝1221a和所述下侧转向丝1221b之间相连续，即二者之间是连在一起的，是一根整体，转向丝固定接口a和转向丝固定接口b之间具有一个空腔供转向丝1221穿行，但在转向丝固定接口a和转向丝固定接口b这两个点位转向丝1221是固定的。这种既可分离又可连续的设计可以增加转向丝1221使用的灵活性，尤其在连续状态下可方便地调整上侧转向丝1221a和/或下侧转向丝1221b的有效长度，所谓有效长度是指参与弯曲操作的实际长度。
在一个实施例中，如图11所示，当所述上侧转向丝1221a和所述下侧转向丝1221b之间相连续时，所述第二推钮座1342上设有转向丝第一缩放结构，所述转向丝第一缩放结构适于同时调整所述上侧转向丝1221a和所述下侧转向丝1221b的有效长度。本实施例中，随着第二推钮座1342上的转向丝第一缩放结构的动作可同时调节上侧转向丝1221a和下侧转向丝1221b的有效长度，则整个装置的松紧度随之调整，包括钳头11在非弯曲状态下的状态：松或者紧。
在一个实施例中，如图11(a)-(c)所示，所述转向丝第一缩放结构包括调节通道和调节杆1346，所述调节通道为空腔并沿所述下盖132的长度方向延伸，所述调节杆1346垂直于所述调节通道的延伸方向从外向内贯穿所述空腔的一侧腔壁后可双向转动地安装于另一侧腔壁上，所述调节杆1346的中段径向开设有通孔；所述调节通道用作所述转向丝1221的穿行和有效长度缩放通道，所述转向丝1221直接缠绕所述调节杆1346一定圈数或穿过所述通孔后再缠绕所述调节杆1346一定圈数。本实施例中，调节杆1346可为哑铃形螺钉，头部端面设有一字横槽，中段稍窄，尾端设有可与空腔的另一侧腔壁配合的螺纹，中段设有一通孔，可通过工具插入一字横槽逆时针或顺时针 转动调节杆1346。转向丝1221可穿过调节杆1346的通孔后再缠绕，也可不穿过通孔而直接缠绕。当为前一缠绕方式时，转动调节杆1346时，不管是逆时针还是顺时针转动，上侧转向丝1221a的有效长度均缩短，下侧转向丝1221b的有效长度在顺时针转动时缩短，逆时针转动时加长。当为后一缠绕方式时，顺时针转动调节杆1346时，上侧转向丝1221a的有效长度缩短，下侧转向丝1221b的有效长度加长，拟时针转动调节杆1346时则完全相反，即上侧转向丝1221a的有效长度加长，下侧转向丝1221b的有效长度缩短。多种缩放调节方式增加了使用的灵活性，可根据实际需要选用。
在一个实施例中，如图12所示，所述转向丝1221依次包括上侧转向丝1221a、调节转向丝1221c和下侧转向丝1221b，三者之间相连续；所述第二推钮座1342上设有转向丝第二缩放结构，所述转向丝第二缩放结构适于通过双向缩放所述调节转向丝1221c的长度来分别双向调整所述上侧转向丝1221a和所述下侧转向丝1221b的有效长度。本实施例中，调节转向丝1221c是位于上侧转向丝1221a和下侧转向丝1221b之间的预留段，用于调节其两侧的有效长度，增加了使用的灵活性。
在一个实施例中，如图12(a)-(c)所示，所述转向丝第二缩放结构包括调节通道、左调节器1347和右调节器1348，所述调节通道为空腔并沿所述下盖32的长度方向延伸，所述左调节器1347和右调节器1348分别垂直于所述调节通道的延伸方向从外向内贯穿所述空腔的一侧腔壁后可双向转动地安装于另一侧腔壁上，所述左调节器1347和右调节器1348的中段均径向开设有通孔；所述调节通道用作所述转向丝1221的穿行和有效长度缩放通道，所述转向丝1221直接分别缠绕所述左调节器1347和右调节器1348一定圈数或穿过各所述通孔后再分别缠绕所述左调节器1347和右调节器1348一定圈数。本实施例中，整根转向丝1221经由两个调节器被分为3段，即分别控制钳头11的弯曲方向的上侧转向丝1221a、下侧转向丝1221b，以及位于两个调节器 之间的调节转向丝1221c。左调节器1347可调整上侧转向丝1221a的有效长度，右调节器1348可调整下侧转向丝1221b的有效长度。同上述第一缩放结构的实施例，不同的缠绕方式的调节效果不同。需要说明的是，当采用穿过通孔后再缠绕的方式时，如图12(b)-(c)所示，通过调节器头部的横槽旋转使得调节器上穿有转向丝1221的通孔位置相对于调节通道打开(通孔的轴向与调节通道的轴向平行)或关闭(通孔的轴向与调节通道的轴向垂直)，类似于阀门的开闭，即可控制穿于其中的转向丝221为锁定(见图12(c))或放松(见图12(b))状态。通过调整上侧转向丝1221a的长度，并选择调节器为关闭状态，可完成对上侧转向丝1221a松紧状态的调节。通过调整下侧转向丝1221b的长度，并选择调节器为闭状态，可完成对下侧转向丝1221b松紧状态的调节。通过调整上侧转向丝1221a及下侧转向丝1221b的长度，并选择两个调节器均为关闭状态，可完成对整个系统转向丝松紧状态的调节。同时，由于转向丝1221与第二推钮座1342的联动作用，使操控弯曲推钮组件134的力度也因此改变，进而改变关联部分的弯曲度。
在一个实施例中，如图8所示，所述手柄13包括上盖131，所述上盖131的内顶面上设有若干卡槽1311；所述第二卡块1343上具有至少一个第二凸起13431，所述第二凸起13431适于嵌入所述卡槽1311以固定所述第二推钮座1342的位置。本实施例中，通过第二凸起13431和卡槽1311的配合实现上一实施例中第二推钮1341的移动距离的锁定，也即锁定了第一鞘管12的弯曲角度。需要说明的是，多个卡槽1311是等间距排列的，间距的大小与弯曲角度的调节精度相关，间距越小，调节精度越高。结合上一实施例，在推动第二推钮1341之前，需要先按住其顶部，此时其下方的第二弹簧1344被压缩，使其高度降低，则其上的第二凸起13431从卡槽1311中脱出，这样就可以自由移动了。待第二推钮1341移动到位后，再将手从其顶部松开，使其在第二弹簧1344的弹力作用下升高，则其上的第二凸起13431嵌入卡槽1311中实 现位置锁定。
在一个实施例中，如图8所示，所述上盖131上设有滑槽1313，所述第二推钮1341经由所述滑槽1313伸出所述上盖131，并适于沿所述滑槽1313来回移动。本实施例中，滑槽1313为第二推钮1341提供了左、右移动的空间，可通过改变滑槽1313的长度来改变第二推钮1341的可移动距离，也就设定了第一鞘管12的可弯曲角度。滑槽1313的长度一般是与多个卡槽1311的总排列长度相同的。
在一个实施例中，如图8所示，所述上盖131上设有导向槽1312，所述导向槽1312适于容纳所述转向丝1221并为其导向。本实施例中，导向槽1312对转向丝1221进行了位置限定和移动轨迹限制，这样可以防止转向丝1221在受力状态下和移动过程中发生位置偏移而影响弯曲角度控制的精确性。上盖131的外顶面上可覆盖软胶，避免异物进入影响操控。
在一个实施例中，所述导向槽1312内设有导向套管。本实施例中，导向套管可降低转向丝1221的摩擦阻力。导向套管的材质可采用具有较高润滑性能的高分子材料。
在一个实施例中，如图7所示，所述第二推钮座1342的容纳腔口部具有向内延伸的第二限位部13421。本实施例中，第二限位部13421可有效防止第二卡块1343从第二推钮座1342中脱出。
在一个实施例中，如图5和图6所示，所述钳头开合控制机构包括设于所述手柄13的下盖132的前部的夹持推钮组件133，所述夹持推钮组件133包括第一推钮座1332，所述第一推钮座1332上设有牵引丝固定接口c，所述牵引丝127固定于所述牵引丝固定接口c；所述第一推钮座1332滑动设于所述下盖132的内底面上，第一推钮座1332中容纳有第一弹簧1334，所述第一弹簧1334的顶面上设有第一卡块1333，所述第一卡块1333内置有头朝上的第一螺钉1335，所述第一螺钉1335上螺接有第一推钮1331。本实施例中， 牵引丝127是固定在牵引丝固定接口c上的，即二者之间没有相对运动。向左或向右推动第一推钮1331，即可使第一推钮座1332向左或向右滑动，使牵引丝127受到向左或向右的拉力。具体来说，如向左推动第一推钮1331(即向逼近钳头11的方向，或称为前移)，牵引丝127受到向左的推力，与牵引丝127连接的钳头11被推动而打开。反之，如向右推动第一推钮1331(即向远离钳头11的方向，或称为后移)，牵引丝127受到向右的拉力，与牵引丝127连接的钳头11被拉动而闭合。第一推钮1331与第二推钮1341均可独立操作，二者互不干扰，可用于单手操作的场合。
在一个实施例中，所述第一卡块1333上具有至少一个第一凸起13331，所述第一凸起13331适于嵌入所述手柄13的上盖131上的若干卡槽1311，以固定所述第一推钮座1332的位置。本实施例中，通过第一凸起13331和卡槽1311的配合实现上一实施例中第一推钮1331的移动距离的锁定，也即锁定了钳头11的打开或闭合状态，打开时也就锁定了开口的大小，闭合时也就锁定了闭合程度，也即剩余开口的大小，统称为开合度。需要说明的是，多个卡槽1311是等间距排列的，间距的大小与钳头11的开合度的调节精度相关，间距越小，调节精度越高。结合上一实施例，在推动第一推钮1331之前，需要先按住其顶部，此时其下方的第一弹簧1334被压缩，使其高度降低，则其上的第一凸起13331从卡槽1311中脱出，这样就可以自由移动了。待第一推钮1331移动到位后，再将手从其顶部松开，使其在第一弹簧1334的弹力作用下升高，则其上的第一凸起13331嵌入卡槽1311中实现位置锁定。
在一个实施例中，所述第一推钮座1332的容纳腔口部具有向内延伸的第一限位部13321。本实施例中，第一限位部13321可有效防止第一卡块1333从第一推钮座1332中脱出。
在一个实施例中，所述手柄13包括应力扩散管136，所述应力扩散管136与所述第一鞘管12对接。本实施例中，应力扩散管136可分散第一鞘管12 与手柄13之间的应力，有效防止第一鞘管12在连接部位变形。
本发明内窥镜手术辅助牵引方法的一个实施例，包括如下步骤：(1)将内窥镜A的镜头套入先端帽导管2的先端帽21上设置的第二贯通通道212中；(2)将先端帽21及先端帽导管2的第二鞘管22的一部分与内窥镜A一同送入目标患处；(3)偏转内窥镜A的镜头，第二鞘管22的第二可弯曲段221随之弯曲，直至内窥镜A的镜头找寻到目标组织；(4)将牵引钳1的钳头11伸入先端帽导管2的接头23上设置的开口中，并经第二鞘管22进入先端帽21上设置的第一贯通通道211，直至在内窥镜A的镜头下看到钳头11；(5)通过操控牵引钳1的手柄13调节牵引钳1的第一鞘管12及先端帽导管2的第二鞘管22的弯曲度和/或弯曲方向；(6)通过操控牵引钳1的手柄13调节牵引钳1的钳头11打开或闭合。
在一个实施例中，具体可按如下流程进行操作：
S1.将内窥镜A的镜头套入先端帽21上设置的第二贯通通道212中，直至内窥镜A的镜头被台阶2121阻挡。
S2.将先端帽21及部分第二鞘管22与内窥镜A一同送入目标患处，自此完成额外器械通道的建立。
S3.在内窥镜A的镜头偏转时，先端帽21随内窥镜A运动带动第二可弯曲段221上的豁口2211发生形变，第二可弯曲段221随内窥镜A改变方向，直至内窥镜A的镜头找寻到目标组织。
S4.将牵引钳1的钳头11及部分第一鞘管12伸入先端帽导管2的接头23上设置的开口中，并穿过第二鞘管22，直至在内窥镜A的镜头下能看到钳头11。
S5.操作牵引钳1的手柄13，相对于先端帽导管2移动手柄13，则第一鞘管12带动钳头11前后移动；旋转手柄13，带动第一鞘管12旋转，进一步带动钳头11旋转，直至钳头11位于适当位置。
S6.操作牵引钳1的13，向下按压第二推钮1341，第二螺钉1345带动第二卡块1343向下移动，第二弹簧1344被压缩，第二卡块1343上的第二凸起13431向下脱离上盖131的卡槽1311，按压住第二推钮1341并向钳头11方向推动，第二推钮座1342前移，接口b上相连的转向丝1221b被拉动前移，由于滚轮135的导向作用，实际外蛇骨122内靠下的转向丝1221b向后移动，外蛇骨122受转向丝1221b的拉拽变形，向下发生弯曲形变，内蛇骨123受外蛇骨122变形挤压，发生与外蛇骨123同方向的弯曲形变。弯曲到适当角度时，操作者松开第二推钮1341，内置在第二推钮座1342中的第二弹簧1344回弹，将第二卡块1343向上顶回对应位置的卡槽1311中，第二卡块1343与与卡槽1331配合，固定弯曲推钮组件134，进而固定转向丝1221b相对于外蛇骨122的位置，锁定保持弯曲角度不变。
S7.向下按压第二推钮1341，第二螺钉1345带动第二卡块1343向下移动，第二弹簧1344被压缩，第二卡块1343上的第二凸起13431向下脱离上盖131的卡槽1311，按压住第二推钮1341并向远离钳头11的方向推动，第二推钮座1342后移，接口a上相连的转向丝1221a被拉动后移，接口b上连接的转向丝1221b向后移动，经滚轮135导向后，转向丝1221b前移，对于外蛇骨122，上侧转向丝1221a收紧，下侧转向丝1221b放松，外蛇骨122向收紧的转向丝所在方向，即向上发生弯曲形变，内蛇骨123受外蛇骨122变形挤压，发生与外蛇骨123同方向的弯曲形变。弯曲到适当角度时，操作者松开第二推钮1341，内置在第二推钮座1342中的第二弹簧1344回弹，将第二卡块1343向上顶回对应位置的卡槽1311中，第二卡块1343与卡槽1331配合，固定弯曲推钮组件134，进而固定转向丝1221相对于外蛇骨122的位置，锁定保持弯曲角度不变。
S8.向下按压第一推钮1331，第一螺钉1335带动第一卡块1333向下移动，第一弹簧1334被压缩，第一卡块1333上的第一凸起13331向下脱离上盖131 的卡槽1311，按压住第一推钮1331并向钳头11的方向推动，第一推钮座1332推动牵引丝127前移，牵引丝127推动钳头11打开。打开到适当位置时，操作者松开第一推钮1331，第一弹簧1334回弹，将第一卡块1333向上顶回对应位置的卡槽1311中，第一卡块1333与卡槽1331配合，固定夹持推钮组件133，进而固定牵引丝127相对于钳头11的位置，锁定保持钳头11的打开位置不变，即开口大小不变。
S9.向下按压第一推钮1331，第一螺钉1335带动第一卡块1333向下移动，第一弹簧1334被压缩，第一卡块1333上的第一凸起13331向下脱离上盖131的卡槽1311，按压住第一推钮1331并向远离钳头11的方向推动，第一推钮座1332推动牵引丝127后移，牵引丝127拉动钳头11闭合。闭合到适当位置时，操作者松开第一推钮1331，第一弹簧1334回弹，将第一卡块1333向上顶回对应位置的卡槽1311中，第一卡块1333与卡槽1331配合，固定夹持推钮组件133，进而固定牵引丝127相对于钳头11的位置，锁定保持钳头11的闭合位置不变，即剩余开口大小不变。在外蛇骨122弯曲状态下，操作钳头11闭合时，向远离钳头方向拉动牵引丝127，会使得牵引丝127紧贴于内蛇骨123的内壁，由于此时内蛇骨123上设置的卡止结构，使得内蛇骨对牵引丝127产生支撑，从而避免影响外蛇骨122的弯曲状态，解决了钳头11的开合与弯曲角度互相干扰的问题。
S10.根据实际需要，不断重复以上S4-S9中的两个或以上步骤，即可实现内窥镜下手术辅助牵引功能。
以上所述仅为本发明的较佳实施例，并不用以限制本发明，凡在本发明的精神和原则之内，所作的任何修改、等同替换、改进等，均应包含在本发明的保护范围之内。

Claims (35)

  1. 一种内窥镜手术辅助牵引系统，其特征在于，包括牵引钳和先端帽导管，所述先端帽导管适于分别为内窥镜及所述牵引钳提供独立的器械贯通通道；所述先端帽导管具有第二可弯曲段，所述第二可弯曲段的长度完全覆盖内窥镜的可弯曲部分；所述牵引钳具有第一可弯曲段，所述第一可弯曲段适于双向弯曲并锁定保持弯曲角度，所述牵引钳的钳头适于开合并锁定保持开合状态。
  2. 根据权利要求1所述的内窥镜手术辅助牵引系统，其特征在于，所述先端帽导管包括依次连接的先端帽、第二鞘管和接头，所述接头用于为所述牵引钳进入所述第二鞘管提供开口；所述先端帽内具有至少两个并列设置的贯通通道，包括用于连接所述第二鞘管的第一贯通通道和用于安装内窥镜的第二贯通通道，使所述第二鞘管与内窥镜并列设置；所述第一贯通通道用于通过所述牵引钳，所述第二可弯曲段位于所述第二鞘管的远端。
  3. 根据权利要求2所述的内窥镜手术辅助牵引系统，其特征在于，所述第二贯通通道中设有向内凸起的台阶，所述台阶用于阻挡内窥镜的镜头。
  4. 根据权利要求2所述的内窥镜手术辅助牵引系统，其特征在于，所述第一贯通通道的起始端的一段和所述第二贯通通道的起始端的一段之间具有隔层，形成隔层段，所述第一贯通通道的末端的一段和所述第二贯通通道的末端的一段之间通过缺口相连通，形成缺口段，所述隔层段与缺口段相邻。
  5. 根据权利要求4所述的内窥镜手术辅助牵引系统，其特征在于，所述缺口段的长度大于所述台阶与所述先端帽的远端面之间的距离。
  6. 根据权利要求2所述的内窥镜手术辅助牵引系统，其特征在于，所述先端帽上在所述第一贯通通道的远端处为斜面。
  7. 根据权利要求6所述的内窥镜手术辅助牵引系统，其特征在于，所述斜面的径向高度大于所述第一贯通通道的内径，且不超过所述先端帽的高度的1/2。
  8. 根据权利要求1所述的内窥镜手术辅助牵引系统，其特征在于，所述第二可弯曲段上具有多个豁口。
  9. 根据权利要求8所述的内窥镜手术辅助牵引系统，其特征在于，所述豁口贯通管壁。
  10. 根据权利要求8所述的内窥镜手术辅助牵引系统，其特征在于，所述豁口的内壁设有软膜。
  11. 根据权利要求8-10任一项所述的内窥镜手术辅助牵引系统，其特征在于，多个所述豁口沿轴向延伸，并在径向按以下方式排布：在同一径向截面上，具有多个沿圆周间隔布设的多个豁口；或者，在同一径向截面上，仅有一个未布满圆周的豁口；或者，在同一径向截面上，仅有一个布满圆周的豁口；前两种径向排布方式中，相邻径向截面上的豁口的位置一致或交错。
  12. 根据权利要求1所述的内窥镜手术辅助牵引系统，其特征在于，所述第二可弯曲段为单壁波纹管；所述单壁波纹管的外壁为：依次递进的环形结构；或者，单个螺旋结构；或者，多个螺旋结构。
  13. 根据权利要求1所述的内窥镜手术辅助牵引系统，其特征在于，所述牵引钳包括依次连接的钳头、第一鞘管和手柄；所述第一鞘管具有所述第一可弯曲段，所述第一可弯曲段中容纳固定有转向丝和牵引丝；所述转向丝的一端连接至所述手柄的鞘管弯曲控制机构，所述鞘管弯曲机构适于通过双向牵拉所述转向丝实现所述第一鞘管的第一可弯曲段双向弯曲并锁定保持弯曲角度；所述牵引丝的一端连接至所述手柄的钳头开合控制机构，另一端连接至所述钳头，所述钳头开合控制机构适于通过双向牵拉所述牵引丝实现所述钳头的开合并锁定保持开合状态。
  14. 根据权利要求13所述的内窥镜手术辅助牵引系统，其特征在于，所述第一鞘管的第一可弯曲段为多层复合结构，由外向内依次为包管、外蛇骨、转向丝、蛇骨接管和内蛇骨；所述牵引丝容纳穿行于所述内蛇骨内；所述外 蛇骨和内蛇骨均适于双向弯曲。
  15. 根据权利要求13所述的内窥镜手术辅助牵引系统，其特征在于，所述外蛇骨适于双向各270°弯曲。
  16. 根据权利要求13所述的内窥镜手术辅助牵引系统，其特征在于，所述内蛇骨适于双向各180°弯曲。
  17. 根据权利要求13所述的内窥镜手术辅助牵引系统，其特征在于，所述外蛇骨、内蛇骨和蛇骨接管三者的轴向近端固定连接；所述内蛇骨在靠近所述钳头的一端保持自由活动状态。
  18. 根据权利要求13所述的内窥镜手术辅助牵引系统，其特征在于，所述转向丝轴向布设于所述第一鞘管两侧，适于通过向逼近所述钳头方向或远离所述钳头方向牵拉其中一侧的转向丝使所述第一鞘管向不同侧弯曲。
  19. 根据权利要求13所述的内窥镜手术辅助牵引系统，其特征在于，所述鞘管弯曲控制机构包括弯曲推钮组件和滚轮；所述弯曲推钮组件滑动设于所述手柄的下盖的中部，所述滚轮固定设于所述下盖的后部；所述转向丝经所述弯曲推钮组件固定后延伸至所述滚轮，并紧贴所述滚轮缠绕后折返。
  20. 根据权利要求19所述的内窥镜手术辅助牵引系统，其特征在于，所述弯曲推钮组件包括第二推钮座，所述第二推钮座上设有转向丝固定接口，所述转向丝固定于所述转向丝固定接口；所述第二推钮座滑动设于所述下盖的内底面上，第二推钮座中容纳有第二弹簧，所述第二弹簧的顶面上设有第二卡块，所述第二卡块内置有头朝上的第二螺钉，所述第二螺钉上螺接有第二推钮。
  21. 根据权利要求20所述的内窥镜手术辅助牵引钳，其特征在于，所述转向丝至少包括上侧转向丝和下侧转向丝，所述上侧转向丝和所述下侧转向丝之间相分离或相连续。
  22. 根据权利要求21所述的内窥镜手术辅助牵引钳，其特征在于，当所 述上侧转向丝和所述下侧转向丝之间相连续时，所述第二推钮座上设有转向丝第一缩放结构，所述转向丝第一缩放结构适于同时调整所述上侧转向丝和所述下侧转向丝的有效长度。
  23. 根据权利要求22所述的内窥镜手术辅助牵引钳，其特征在于，所述转向丝第一缩放结构包括调节通道和调节杆，所述调节通道为空腔并沿所述下盖的长度方向延伸，所述调节杆垂直于所述调节通道的延伸方向从外向内贯穿所述空腔的一侧腔壁后可双向转动地安装于另一侧腔壁上，所述调节杆的中段径向开设有通孔；所述调节通道用作所述转向丝的穿行和有效长度缩放通道，所述转向丝直接缠绕所述调节杆一定圈数或穿过所述通孔后再缠绕所述调节杆一定圈数。
  24. 根据权利要求21所述的内窥镜手术辅助牵引钳，其特征在于，所述转向丝依次包括上侧转向丝、调节转向丝和下侧转向丝，三者之间相连续；所述第二推钮座上设有转向丝第二缩放结构，所述转向丝第二缩放结构适于通过双向缩放所述调节转向丝的长度来分别双向调整所述上侧转向丝和所述下侧转向丝的有效长度。
  25. 根据权利要求24所述的内窥镜手术辅助牵引钳，其特征在于，所述转向丝第二缩放结构包括调节通道、左调节器和右调节器，所述调节通道为空腔并沿所述下盖的长度方向延伸，所述左调节器和右调节器分别垂直于所述调节通道的延伸方向从外向内贯穿所述空腔的一侧腔壁后可双向转动地安装于另一侧腔壁上，所述左调节器和右调节器的中段均径向开设有通孔；所述调节通道用作所述转向丝的穿行和有效长度缩放通道，所述转向丝直接分别缠绕所述左调节器和右调节器一定圈数或穿过各所述通孔后再分别缠绕所述左调节器和右调节器一定圈数。
  26. 根据权利要求20所述的内窥镜手术辅助牵引系统，其特征在于，所述手柄包括上盖，所述上盖的内顶面上设有若干卡槽；所述第二卡块上具有 至少一个第二凸起，所述第二凸起适于嵌入所述卡槽以固定所述第二推钮座的位置。
  27. 根据权利要求26所述的内窥镜手术辅助牵引系统，其特征在于，所述上盖上设有滑槽，所述第二推钮经由所述滑槽伸出所述上盖，并适于沿所述滑槽来回移动。
  28. 根据权利要求26所述的内窥镜手术辅助牵引系统，其特征在于，所述上盖上设有导向槽，所述导向槽适于容纳所述转向丝并为其导向。
  29. 根据权利要求28所述的内窥镜手术辅助牵引系统，其特征在于，所述导向槽内设有导向套管。
  30. 根据权利要求20所述的内窥镜手术辅助牵引系统，其特征在于，所述第二推钮座的容纳腔口部具有向内延伸的第二限位部。
  31. 根据权利要求13所述的内窥镜手术辅助牵引系统，其特征在于，所述钳头开合控制机构包括设于所述手柄的下盖的前部的夹持推钮组件，所述夹持推钮组件包括第一推钮座，所述第一推钮座上设有牵引丝固定接口，所述牵引丝固定于所述牵引丝固定接口；所述第一推钮座滑动设于所述下盖的内底面上，第一推钮座中容纳有第一弹簧，所述第一弹簧的顶面上设有第一卡块，所述第一卡块内置有头朝上的第一螺钉，所述第一螺钉上螺接有第一推钮。
  32. 根据权利要求31所述的内窥镜手术辅助牵引系统，其特征在于，所述第一卡块上具有至少一个第一凸起，所述第一凸起适于嵌入所述手柄的上盖上的若干卡槽，以固定所述第一推钮座的位置。
  33. 根据权利要求31所述的内窥镜手术辅助牵引系统，其特征在于，所述第一推钮座的容纳腔口部具有向内延伸的第一限位部。
  34. 根据权利要求13所述的内窥镜手术辅助牵引系统，其特征在于，所述手柄包括应力扩散管，所述应力扩散管与所述第一鞘管对接。
  35. 一种内窥镜手术辅助牵引方法，其特征在于，利用权利要求1-34任一项所述的内窥镜手术辅助牵引系统进行辅助牵引，包括如下步骤：
    S1：将内窥镜的镜头套入先端帽导管的先端帽上设置的第二贯通通道中；
    S2：将先端帽及先端帽导管的第二鞘管的一部分与内窥镜一同送入目标患处；
    S3：偏转内窥镜的镜头，第二鞘管的第二可弯曲段随之弯曲，直至内窥镜的镜头找寻到目标组织；
    S4：将牵引钳的钳头伸入先端帽导管的接头上设置的开口中，并经第二鞘管进入先端帽上设置的第一贯通通道，直至在内窥镜的镜头下看到钳头；
    S5：通过操控牵引钳的手柄调节牵引钳的第一鞘管及先端帽导管的第二鞘管的弯曲度和/或弯曲方向；
    S6：通过操控牵引钳的手柄调节牵引钳的钳头打开或闭合。
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