WO2021120178A1 - 一种微创手术取物器械 - Google Patents

一种微创手术取物器械 Download PDF

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Publication number
WO2021120178A1
WO2021120178A1 PCT/CN2019/127039 CN2019127039W WO2021120178A1 WO 2021120178 A1 WO2021120178 A1 WO 2021120178A1 CN 2019127039 W CN2019127039 W CN 2019127039W WO 2021120178 A1 WO2021120178 A1 WO 2021120178A1
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Prior art keywords
tube
basket
wire
head end
catheter
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PCT/CN2019/127039
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English (en)
French (fr)
Inventor
李晓春
徐潮伟
张金同
刘春俊
李宁
李常青
奚杰峰
Original Assignee
南微医学科技股份有限公司
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Application filed by 南微医学科技股份有限公司 filed Critical 南微医学科技股份有限公司
Priority to PCT/CN2019/127039 priority Critical patent/WO2021120178A1/zh
Publication of WO2021120178A1 publication Critical patent/WO2021120178A1/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
    • A61B17/22—Implements for squeezing-off ulcers or the like on the inside of inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; Calculus removers; Calculus smashing apparatus; Apparatus for removing obstructions in blood vessels, not otherwise provided for
    • A61B17/221—Gripping devices in the form of loops or baskets for gripping calculi or similar types of obstructions

Definitions

  • This application relates to the technical field of medical devices, and in particular to a minimally invasive surgical retrieval device.
  • ERCP surgery that is, endoscopic retrograde cholangiopancreatography
  • endoscopic retrograde cholangiopancreatography is a minimally invasive surgery performed with endoscopy. It is often used for lesion resection and stone removal in the biliary and pancreatic tract.
  • the stone-removing basket has a good performance in clinical operations.
  • a typical stone retrieval basket includes handles, catheters, and nets. The handle at the proximal end manipulates the net at the distal end through the catheter and the operating wire in the catheter, so that the basket wire is opened and closed, and the foreign body in the lesion is taken out.
  • the net at the distal end includes at least one basket wire and a front end fixing member, mainly hexagonal nets formed of stainless steel wires and nickel-titanium spiral nets. Whether it is based on the hexagonal stainless steel wire or the nickel-titanium spiral type, the wire basket is connected with the front fixing part by welding or riveting. After it is formed, the other parts are assembled to complete the final stone removal. Net basket products. It can be seen that in the process of welding the wire basket wire and the front-end fixing member, the operator's technique or the operating state of the equipment will affect the connection force between the stone-removing wire basket wire and the front-end fixing member. If the operation is improper or the equipment fluctuates, the connection may be weak, and the stone removal basket may be broken during the operation.
  • the overall volume of the stone-removing basket is small, resulting in a thinner wire in the basket.
  • the distal end of the net needs to be folded in the catheter at the beginning of the operation, and only protrudes from the catheter when it reaches the vicinity of the lesion, and the net is made by the elastic force of the basket wire itself or the thrust of the operating wire.
  • the basket wire bends and opens the net mouth. Therefore, the deformation of the mesh basket wire is relatively large, which further increases the possibility of the mesh basket wire and the front end fixing member breaking.
  • the present application provides a minimally invasive surgical retrieval instrument to solve the problem of easy breakage between the wire of the stone retrieval basket and the front end fixing member.
  • the present application provides a minimally invasive surgical retrieval instrument, comprising: a catheter and a basket part, the basket part is connected to the distal end of the catheter; wherein the catheter is provided with an operating wire connected to the basket part;
  • the mesh basket part includes a plurality of mesh basket wires and a head end tube; the head end tube is a multi-lumen tube structure including at least two cavities; one end of each of the mesh basket wires extends from the head end tube After passing through one cavity, it passes back through the other cavity of the head end tube, so that the two ends of the mesh basket wire are folded back and then connected to the operating wire; the mesh basket wire is shaped into a curved structure.
  • the net basket portion further includes a head end cap connected to the distal end of the head end tube; the distal end of the head end cap has an arc transition structure.
  • the head end cap is a cone structure with a distal end diameter smaller than a proximal end diameter
  • the proximal end of the head end cap is provided with a thread or a hook, and the head end tube is provided with a thread or a locking groove, so that the head end cap is connected to the distal end of the head end tube through the thread or the hook .
  • one or more of the plurality of mesh basket wires is provided with a narrowing part
  • the cross-sectional area of the narrowed portion is smaller than the cross-sectional area of the non-narrowed portion on the mesh basket wire, so as to reduce the tensile strength of the narrowed portion.
  • the net basket portion further includes a tightening tube, a connecting tube, and a boosting tube that are sequentially arranged on the operating wire from the distal end to the proximal end;
  • the tightening tube gathers the proximal end of the mesh basket wire through a round tube structure; the operating wire is connected to the proximal end of the mesh basket wire through the connecting tube and the booster tube.
  • both ends of the tightening pipe, the connecting pipe and the boosting pipe have an oblique angle structure.
  • the retrieval device further includes a handle, and the handle includes a front handle and a rear handle;
  • the rear handle is connected to the proximal end of the catheter through the front handle; the rear handle is connected to the operating wire to manipulate the basket portion by pushing and pulling the rear handle to make the basket portion extend or Retract the catheter.
  • the catheter is also provided with a liquid injection cavity; the front handle is provided with a luer connector that communicates with the liquid injection cavity.
  • the distal end of the catheter is also provided with a double-lumen end cap;
  • the dual-lumen end cap includes two lumen, one of which is connected to the inner cavity of the catheter for passing through the basket portion, and the other is for passing the guide wire;
  • the distal end face has an inclined structure.
  • a plurality of the mesh basket wires are connected to the distal end of the head end tube to form a bundle of side-by-side structures with the same extending direction as the axial direction of the catheter.
  • the present application provides a minimally invasive surgical retrieval device, including: a catheter, and a basket part connected to the distal end of the catheter; wherein the catheter is provided with an operating wire connected to the basket part; the basket The part includes multiple mesh basket wires and a head end tube; the head end tube is a multi-lumen tube that includes at least two cavities; one end of each mesh basket wire passes through a cavity of the head end tube, and then passes through the head end tube The other cavity is passed back to form a folded structure to connect multiple basket wires at the distal end through the head end tube; all the basket wires finally form a bunch of side-by-side structures with the same extension direction as the axial direction of the catheter; the basket wires are shaped as Bending structure; the two ends of the basket wire are folded back and then connected to the operating wire.
  • the retrieval device provided by the application adopts the folded structure formed by the mesh basket wire and the head end tube, and finally forms a bundle of parallel wire structure with the same axial direction as the catheter, which realizes the connection of multiple mesh basket wires at the distal end and improves the mesh basket wire.
  • all mesh basket wires are the same axial direction as the catheter, which is conducive to the mesh basket receiving the outer tube.
  • Figure 1 is a schematic diagram of the structure of a minimally invasive surgical retrieval device according to this application.
  • Figure 2 is a schematic structural diagram of another minimally invasive surgical retrieval device of this application.
  • Figure 3 is a schematic diagram of the cross-shaped threading form of the mesh basket wire of the application.
  • Figure 4 is a schematic diagram of the parallel threading form of the mesh basket wire of the application.
  • Figure 5 is a schematic diagram of the head end pipe structure of the threaded connection of the application.
  • Fig. 6 is a schematic diagram of the structure of the head end pipe welded and connected in this application;
  • Figure 7 is a schematic diagram of the structure of the head cap of the application.
  • Fig. 8 is a schematic diagram of the structure of the net basket part when the application is threaded
  • Fig. 9 is a schematic diagram of the structure of the mesh basket part when the application is welded and connected;
  • FIG. 10 is a schematic diagram of the structure of the narrowing part on the wire mesh of the present application.
  • Fig. 11 is a schematic diagram of the structure of the narrowing portion on another mesh basket wire of the present application.
  • Figure 12 is a schematic diagram of the working condition when the narrowing part of the application is broken
  • Figure 13 is a schematic diagram of the structure of the connection area between the basket part and the operating wire of the application.
  • Fig. 14 is a schematic diagram of the structure of the dual-cavity end cap of the present application.
  • the distal end the end where the entire instrument is placed in the human body
  • this end is mainly used to perform surgical actions on the tissue
  • the end outside the body is called the proximal end, and this end is mainly Operate by the operator of the operation.
  • the distal end of each component refers to the end close to the inside of the body
  • the proximal end of each component refers to the end close to the outside of the body.
  • a minimally invasive surgical retrieval device mainly includes: a catheter 3 and a net basket part 1, wherein the net basket part 1 is connected to the distal end of the catheter 3.
  • the catheter 3 is provided with an operating wire 2 connected to the basket portion 1.
  • the catheter 3 can extend from outside the patient's body to the lesion in the patient's body, so as to operate outside the patient's body, so that the basket portion 1 can perform the fetching action in the body. Therefore, The length of the duct 3 should be sufficient to meet this distance.
  • the catheter 3 may be a plastic tube, and a steel wire support is provided inside the plastic tube, so that the catheter 3 can enter the patient's body along the endoscopic lumen.
  • the operating wire 2 is used to transmit the driving action of the basket portion 1, that is, to transmit the stretching and pushing force. Therefore, the operating wire 2 can be a steel wire rope structure, and multi-strand wire or single wire can be selected according to the actual application environment.
  • the mesh basket portion 1 includes a plurality of mesh basket wires 11 and a head end tube 12.
  • the head end tube 12 is a multi-lumen tube including at least two cavities, and the cavities penetrate both ends of the head end tube 12 in the axial direction. . After one end of each mesh basket wire 11 passes through one cavity of the head end tube 12, it passes back through another cavity of the head end tube 12 to form a folded structure to pass through the head end tube 12.
  • the end tube 12 is connected to a plurality of said basket wires 11 at the distal end; all the basket wires 11 finally form a bunch of side-by-side structure with the same extension direction as the axial direction of the catheter 3, so that the basket wires 11 can move in the catheter 3 more easily;
  • the mesh basket wire 11 is shaped into a curved structure. The two ends of the basket wire 11 are folded back and then connected to the operating wire 2.
  • the mesh basket wire 11 can be a stainless steel wire, a nickel titanium wire, or a mixed wire of nickel titanium wire and stainless steel.
  • the mesh basket wire 11 can be heat-set or mechanically bent, and the shape is hexagonal or spiral. Type bending structure.
  • the head end tube 12 may be provided with multiple through holes in the axial direction to form multiple cavities. For example, two or more through holes can be opened on the head end tube 12. During the assembly process, one or more basket wires can be passed through one hole, and then passed back through another hole after bending.
  • the net basket part 1 includes a plurality of net basket wires 11, the above operation can be repeated to connect the plurality of net basket wires 11 and the head end tube 12 together.
  • the mesh basket wire 11 passes through the head end tube 12, it can adopt various forms, as shown in Figures 3 and 4, taking the head end tube 12 as an example, two mesh baskets are provided with four cavities.
  • the head end tube 12 is porous, so that one or more wires of the basket wire 11 first pass through one hole of the head end tube 12, and then fold back from the other. A hole is passed back, and this structure is repeated until all the basket wires 11 pass through the head end tube 12, and all the basket wires finally form a bundle of parallel wires structure that is the same axially as the catheter. Then, arrange the basket wire 11 to ensure that after the same wire passes through the two holes, the length of the head and tail ends from the head end tube 11 is equal.
  • the material-removing device can save the riveting or welding process between the wire 11 and the head end tube 12 of the traditional stone-removing mesh basket, especially to avoid the difficult welding problem of nickel-titanium wire and stainless steel.
  • all mesh basket wires have the same axial direction as the catheter, which is beneficial for the mesh basket to enter the outer tube.
  • the basket portion 1 further includes a head end cap 13 connected to the distal end of the head end tube 12; the head end cap The distal end of 13 is a circular arc transition structure. Further, the head end cap 13 is a cone structure with a distal end diameter smaller than that of the proximal end; the proximal end of the head end cap 13 is provided with a thread or a hook, and the head end tube 12 is provided with a thread or a hook. Groove, so that the head end cap 13 is connected to the distal end of the head end tube 12 through a screw thread or a hook.
  • the head end cap 13 is designed as a conical structure with a narrow distal end and a wide proximal end, and the distal end of the head end cap 13 is rounded to form a smooth transition.
  • a light hole or a threaded hole can be opened at the proximal end of the head end cap 13, the distal end of the head end tube 12 is inserted into the head end cap 13, and then threaded connection, hook connection, welding, The connection method such as crimping is fixed. It is also possible to open a light hole or threaded hole at the distal end of the head end cap 13.
  • a positioning pillar structure is designed at the proximal end of the head end cap 13, so that the head end cap 13 is inserted into the head end tube 12, and then threaded and hooked , Welding, crimping and other connection methods for fixing.
  • the head end cap 13 can be connected to the head end tube 12 through threads, snaps, welding, etc., and the front end fixing member is divided into two parts, namely the head end cap 13 and the head end tube 12. Among them, the front end of the head end cap 13 is processed into a cone and rounded. This shape has a good guiding effect and can ensure that the basket part 1 smoothly passes through the endoscope and enters the human body, and will not cause damage to the endoscope and human organs. hurt.
  • This application omits the riveting or welding process of the traditional stone-retrieving basket, especially avoids the difficulty of welding nickel-titanium wire and stainless steel, so as to maximize the connection force of the stone-retrieving basket wire and the smoothness of insertion into the body.
  • one or more of the plurality of mesh basket wires 11 is provided with a narrowing portion;
  • the cross-sectional area is smaller than the cross-sectional area of the non-narrowed portion of the basket wire 11 to reduce the tensile strength of the narrowed portion. That is, in the mesh basket wire 11 of the present application, there are one or more mesh basket wires 11, and the diameters of some sections of them are narrowed by grinding, so that the cross section becomes smaller and the tensile strength is reduced.
  • tools such as stone crushers.
  • this application does not adopt all the mesh basket wires 11 to be provided with a narrowing part.
  • the narrowing part can be at the distal or proximal end of the mesh basket wire 11, or at the mesh basket.
  • Figure 12 if stone incarceration occurs during stone retrieval, when the mesh basket wire 11 is stressed, the mesh basket wire 11 with the narrowed part will break first, so that the stone is released and the instrument can be withdrawn smoothly.
  • it can also be designed to have at least one wire whose strength is higher than other wires, to ensure that after the basket wire is broken, at least one of the basket wire 11 and the head end cap 13 are connected together to prevent the head end cap 13 from falling off. In the human body.
  • the net basket portion 1 further includes a direction from the distal end to the proximal end, which are sequentially arranged in The tightening tube 14, the connecting tube 15 and the boosting tube 16 on the operating wire 2; the tightening tube 14 adopts a round tube structure to gather the proximal end of the mesh basket wire 11; the operating wire 2 passes through the The connecting tube 15 and the boosting tube 16 are connected to the proximal end of the mesh wire 11. Further, both ends of the tightening tube 14, the connecting tube 15 and the boosting tube 16 are angled structures.
  • the net basket portion 1 as a whole may include a traction part and a stone-removing part, wherein the stone-removing part is the above-mentioned net basket wire 11, the head end tube 12 and the head end cap 13, so as to open and close the net basket wire 11, Grab foreign objects in the patient's body.
  • the traction part of the basket part 1 may be composed of a stainless steel rope and a stainless steel booster tube 16.
  • the stainless steel rope can provide good pushing performance and cornering performance, so as to drive the stone taking part of the basket part 1 to move.
  • the proximal end of the mesh wire 11 can be folded using a tightening tube 14, and a connecting tube 15 can be used for connection.
  • the two ends of the tightening pipe 14, the connecting pipe 15 and the boosting pipe 16 have an oblique angle structure.
  • the oblique angle structure allows the basket portion 1 to move smoothly in the duct 3.
  • the retrieval device further includes a handle 4, and a person performing an operation can manipulate the handle 4 to generate corresponding actions, such as pushing, stretching, and rotating.
  • the handle 4 includes a front handle 41 and a rear handle 42. Wherein, the rear handle 42 is connected to the proximal end of the catheter 3 through the front handle 41; the rear handle 42 is connected to the operating wire 2. According to the above-mentioned traction part, the rear handle 42 can be connected to the assistant on the operating wire 2.
  • the catheter 3 can be assembled with the sheath tube, the front handle, the locking nut, the rear handle and other components to complete the final retrieval device product.
  • the catheter 3 is also provided with a liquid injection cavity;
  • the front handle 41 is provided with a luer connector that communicates with the liquid injection cavity.
  • the Luer connector provided on the front handle 41 can be connected to the liquid injection channel in the catheter 3, and the liquid injection channel extends to the net basket portion 1 at the distal end, thereby forming a complete injection channel.
  • the retrieval device provided in this application can be used for retrieval operations in internal cavities, such as digestive tract, duodenum, bile duct, pancreatic duct, etc.
  • the cavity tends to be flat, and the retrieval device can easily reach or reach the location of the lesion under the guidance of the endoscopic cavity.
  • the retrieval device needs to go through a complicated path to enter the bile duct or pancreatic duct.
  • the travel path of the retrieval device needs to be guided by a guide wire. Therefore, in some of the embodiments provided in this application, the distal end of the catheter 3 is also provided with a dual-lumen end cap 31, which can be matched with the guide wire, so that the distal end of the catheter 3 can follow the guide wire. March.
  • the dual-lumen end cap 31 includes two cavities, one of which is connected to the inner cavity of the catheter 3 for passing through the basket portion 1, and the other is used for The guide wire is passed; the distal end surface of the dual-lumen end cap 31 is an inclined structure.
  • the distal end of the catheter 3 is provided with a double-lumen end cap 31.
  • One cavity of the double-cavity end cap 31 can pass through the basket portion 1, and the other cavity can pass through the guide wire. By sliding the lumen on the guide wire, the distal end of the catheter 3 can travel along the guide wire and enter the lesion location.
  • the distal end surface of the dual-cavity end cap 31 may be a dual-cavity portion, and the proximal end surface may be a single-cavity portion that only passes through the basket portion 1.
  • the single-cavity portion can be used to pass through the basket portion 1 on the one hand, and the other On the one hand, it is also used to connect the distal end of the catheter 3, and the single-lumen portion and the double-lumen portion can be an integral structure.
  • the guide wire cavity side at the distal end of the double cavity is also provided with a guiding bevel structure.
  • the outer contour width for passing the basket portion 1 is larger than the outer contour width for passing the guide wire portion.
  • the minimally invasive surgical retrieval device provided in this application adopts a structure in which the head end tube 12 passes through the mesh basket wire 11, and the gap between the mesh basket wire 11 and the head end tube 12 is The connection strength is the tensile strength of the basket wire 11 itself. Therefore, the retrieval device provided by the present application can save the traditional riveting or welding process, especially avoid welding between the nickel-titanium wire and the stainless steel, and improve the instability of the welding and crimping structure.
  • the head cap 13 by installing a conical head cap 13 at the front end of the head tube 12, the head cap 13 can have a narrow distal end and a wide proximal end structure to achieve more effective penetration.
  • the present application also installs a double-lumen end cap 31 that can pass through the guide wire at the distal end of the catheter 3. After the guide wire is preset with other instruments before the stone is removed, the removal instrument can be guided by the preset guide wire to quickly reach the location of the lesion. .
  • the two ends of the connecting tube 15 and the tightening tube 17 of the net basket part 1 are angled to reduce the cross-sectional drop, so that the net basket part 1 can move smoothly in the outer tube.
  • the retrieval device provided by the present application also has at least one mesh basket wire 11 provided with narrowed parts with different cross-sectional areas.
  • the narrowed parts with a smaller cross-sectional area have low strength, while those with a large cross-sectional area are not retractable.
  • the narrow part is strong. In the process of taking the stone, when the stone is incarcerated and the mesh basket wire 11 is stressed, the narrowing part will break first, allowing the stone to be released and ensuring that the instrument can be withdrawn smoothly.

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Abstract

一种微创手术取物器械，包括：导管（3），以及连接导管（3）远端的网篮部（1）；其中，导管（3）中设有连接网篮部（1）的操作丝（2）；网篮部（1）包括多根网篮丝（11）以及头端管（12）；头端管（12）为至少包括两个腔道的多腔管。每一根网篮丝（11）的一端从头端管（12）的一个腔道穿过后，再从头端管（12）的另一个腔道穿回，形成回折结构；以通过头端管（12）在远端连接多根网篮丝（11）；所有网篮丝（11）最后形成一束延伸方向与导管（3）轴向相同的并排结构；网篮丝（11）定型为弯曲结构。网篮丝（11）的两端经回折后连接操作丝（2）。该取物器械通过多根网篮丝（11）与头端管（12）形成的回折结构，实现多根网篮丝（11）在远端的连接，提高网篮丝（11）的连接强度。同时所有网篮丝（11）与导管（3）轴向相同，有利于网篮收入外管。

Description

一种微创手术取物器械 技术领域
本申请涉及医疗器械技术领域，尤其涉及一种微创手术取物器械。
背景技术
ERCP手术，即经内镜逆行性胰胆管造影术，是一种配合内镜实施的微创手术，常用于在胆道、胰道内进行病灶切除、取石等。取石网篮作为ERCP手术中常用的一种取异物器械，在临床手术中有良好的表现。典型的取石网篮，包括手柄、导管以及网。位于近端的手柄通过导管以及导管内的操作丝操纵位于远端的网，以使网篮丝张开和收拢，将病灶部位的异物取出。
其中，远端的网包括至少一根网篮丝和前端固定件，以形成不锈钢丝的六角型网和镍钛螺旋型网为主。无论是基于不锈钢丝六角型还是基于镍钛螺旋型的取石网篮，都是将网篮丝与前端固定件通过焊接或铆接的工艺连接在一起，待其成型后，再组装其它部件完成最终取石网篮产品。可见，在网篮丝与前端固定件进行焊接的这一过程中，操作者的手法或设备的运行状态都会影响到取石网篮丝和前端固定件的连接力。如果操作不当或者设备出现波动，就有可能出现连接不牢，使取石网篮在手术中具有断裂的可能。
另外，由于微创手术的操作空间有限，取石网篮的整体体积较小，导致网篮丝较细。并且在手术过程中，远端的网在手术开始时需要收拢在导管内，在到达病灶位置附近时，才从导管中伸出，并通过网篮丝自身的弹力或者操作丝的推力，使网篮丝产生弯曲，张开网口。因此，网篮丝的变形量较大，也进一步增加网篮丝与前端固定件发生断裂的可能性。
发明内容
本申请提供了一种微创手术取物器械，以解决取石网篮的网篮丝与前端固定件之间容易断裂的问题。
本申请提供一种微创手术取物器械，包括：导管和网篮部，网篮部连接所述导管的远端；其中，所述导管中设有连接所述网篮部的操作丝；所述网篮部包括多根网篮丝以及头端管；所述头端管为包括至少两个腔道的多腔管结构；每一根所述网篮丝的一端从所述头端管的一个腔道穿过后，再从所述头端管的另一个腔道穿回，使所述网篮丝的两端经回折后连接所述操作丝；所述网篮丝定型为弯曲结构。
可选的，所述网篮部还包括头端帽，所述头端帽连接所述头端管的远端；所述头端帽的远端为圆弧过渡结构。
可选的，所述头端帽为远端直径小于近端直径的圆锥体结构；
所述头端帽的近端设有螺纹或卡勾，所述头端管上设有螺纹或卡槽，以使所述头端帽通过螺纹或卡勾，连接所述头端管的远端。
可选的，多根所述网篮丝中的一根或多根网篮丝上设有收窄部；
所述收窄部的横截面积小于所述网篮丝上非收窄部的横截面积，以降低所述收窄部的抗拉强度。
可选的，所述网篮部还包括从远端向近端方向，依次设置在所述操作丝上的收紧管、连接管以及助推管；
所述收紧管通过圆管结构，将网篮丝的近端收拢；所述操作丝通过所述连接管以及助推管连接所述网篮丝的近端。
可选的，所述收紧管、连接管以及助推管两端为斜角结构。
可选的，所述取物器械还包括手柄，所述手柄包括前手柄和后手柄；
所述后手柄通过所述前手柄连接所述导管的近端；所述后手柄连接所述操作丝，以通过推拉所述后手柄操纵所述网篮部，使所述网篮部伸出或收回导管。
可选的，所述导管内还设有注液腔道；所述前手柄上设有连通所述注液腔道的鲁尔接头。
可选的，所述导管的远端还设有双腔端帽；
所述双腔端帽包括两个腔道，其中一个腔道连通所述导管的内腔，用于通过所述网篮部，另一个腔道用于通过导丝；所述双腔端帽的远端端面为倾斜结构。
可选的，多根所述网篮丝通过连接在所述头端管的远端，形成一束延伸方向与导管轴向相同的并排结构。
由以上技术方案可知，本申请提供一种微创手术取物器械，包括：导管，以及连接所述导管远端的网篮部；其中，导管中设有连接网篮部的操作丝；网篮部包括多根网篮丝以及头端管；头端管为至少包括两个腔道的多腔管；每一根网篮丝的一端从头端管的一个腔道穿过后，再从头端管的另一个腔道穿回，形成回折结构，以通过头端管在远端连接多根网篮丝；所有网篮丝最后形成一束延伸方向与导管轴向相同的并排结构；网篮丝定型为弯曲结构；网篮丝的两端经回折后连接操作丝。本申请提供的取物器械通过网篮丝与头端管形成的回折结构，最后形成一束与导管轴向相同的并排丝结构，实现多根网篮丝在远端的连接，提高网篮丝的连接强度；同时所有网篮丝与导管轴向相同，有利于网篮收入外管。
附图说明
为了更清楚地说明本申请的技术方案，下面将对实施例中所需要使用的附图作简单地介绍，显而易见地，对于本领域普通技术人员而言，在不付出创造性劳动的前提下，还可以根据这些附图获得其他的附图。
图1为本申请一种微创手术取物器械的结构示意图；
图2为本申请另一种微创手术取物器械的结构示意图；
图3为本申请网篮丝十字形穿线形式示意图；
图4为本申请网篮丝平行穿线形式示意图；
图5为本申请螺纹连接的头端管结构示意图；
图6为本申请焊接连接的头端管结构示意图；
图7为本申请头端帽的结构示意图；
图8为本申请螺纹连接时网篮部的结构示意图；
图9为本申请焊接连接时网篮部的结构示意图；
图10为本申请一种网篮丝上收窄部的结构示意图；
图11为本申请另一种网篮丝上收窄部的结构示意图；
图12为本申请收窄部断裂时的工作状况示意图；
图13为本申请网篮部与操作丝连接区域的结构示意图；
图14为本申请双腔端帽的结构示意图。
具体实施方式
下面将详细地对实施例进行说明，其示例表示在附图中。下面的描述涉及附图时，除非另有表示，不同附图中的相同数字表示相同或相似的要素。以下实施例中描述的实施方式并不代表与本申请相一致的所有实施方式。仅是与权利要求书中所详述的、本申请的一些方面相一致的系统和方法的示例。
本申请提供的技术方案中，为了便于描述，将整个器械置入人体内的一端称为远端，这一端主要用于对组织实施手术动作；位于体外的一端称为近端，这一端主要用于手术实施者进行操作。本申请除另有说明外，各部件所称的远端都是靠近体内一侧的一端，各部件所称的近端都是指靠近体外一侧的一端。
参见图1，为本申请一种微创手术取物器械的结构示意图。由图1可知，本申请提供的一种微创手术取物器械，主要包括：导管3和网篮部1，其中，网篮部1连接在所述导管3的远端。其中，所述导管3中设有连接所述网篮部1的操作丝2。
本申请技术方案中，如图2所示，导管3可以从患者的体外一直延伸到患者体内的病灶部位，以在患者的体外进行操作，使网篮部1在体内实施取物动作，因此，导管3的长度应足够满足这一距离。导管3可以为塑料管，并在塑料管的内部设有钢丝支撑，以便于导管3可以沿着内镜腔道进入患者体内。操作丝2用于传递网篮部1的驱动动作，即传递拉伸、推送力，因此，操作丝2可以为钢丝绳结构，并且根据实际应用环境选择采用多股丝或单丝。
所述网篮部1包括多根网篮丝11以及头端管12，所述头端管12为包括至少两个腔道的多腔管，腔道沿头端管12轴向贯穿其两端。每一根所述网篮丝11的一端从所述头端管12的一个腔道穿过后，再从所述头端管12的另一个腔道穿回，形成回折结构，以通过所述头端管12在远端连接多根所述网篮丝11；所有网篮丝11最后形成一束延伸方向与导管3轴向相同的并排结构，以便网篮丝11更容易在导管3中运动；所述网篮丝11定型为弯曲结构。所述网篮丝11的两端经回折后连接所述操作丝2。
本申请中，所述网篮丝11可以为不锈钢丝，镍钛丝，或者为镍钛丝和不锈钢混编丝，网篮丝11可以热定型或机械折弯的方式，定型为六角型或螺旋型弯曲结构。实际应用中，头端管12可以在轴向开设多个通孔，以形成多个腔道。例如，可以在头端管12上开设两个及两个以上通孔。在装配过程中，可以通过将一根或多根网篮丝从一个孔穿过，折弯后再从另一个孔穿回。当网篮部1包括多根网篮丝11时，可以重复以上操作，以将多根网篮丝11与头端管12连接在一起。为了实现连接，网篮丝11在穿过头端管12时，可以通过多种形式，如图3、图4所示，以头端管12上设有4个腔道为例，两根网篮丝11的穿过形式可以在头端管12的端部形成十字交叉，也可以并列以“＝”号形方式。
本申请提供的技术方案中，如图5、图6所示，头端管12开多孔，使得网篮丝11先一根或多根丝先穿过头端管12的一个孔，再折回从另一个孔穿回，重复这样的结构，直至所有网篮丝11都穿过头端管12，所有网篮丝最后形成一束与导管轴向相同的并排丝结构。然后，整理网篮丝11，保证同一根丝穿过两孔后，首尾两端距头端管11的长度相等。所述取物器械对比一般的取石网篮，可以省去传统取石网篮的网篮丝11与头端管12之间 的铆接或者焊接工艺，尤其是避免镍钛丝和不锈钢难焊接的难题，采用头端管12穿网篮丝的结构，网篮丝11的连接强度就是网篮丝11本身的抗拉强度，因此可以大大提高连接强度，因此避免焊接、压接结构工艺造成的不稳定性。同时所有网篮丝与导管轴向相同，有利于网篮收入外管
在本申请的部分实施例中，如图7所示，所述网篮部1还包括头端帽13，所述头端帽13连接所述头端管12的远端；所述头端帽13的远端为圆弧过渡结构。进一步地，所述头端帽13为远端直径小于近端直径的圆锥体结构；所述头端帽13的近端设有螺纹或卡勾，所述头端管12上设有螺纹或卡槽，以使所述头端帽13通过螺纹或卡勾，连接所述头端管12的远端。
如图8、图9所示，头端帽13设计为一个远端窄近端宽的圆锥体结构，并将头端帽13的远端倒圆形成光滑过渡。为了保证安装的同轴度，可以在头端帽13的近端开设光孔或螺纹孔，将头端管12的远端插入头端帽13内，再用螺纹连接、卡勾连接、焊接、压接等连接方式进行固定。也可以在头端帽13远端开设光孔或螺纹孔，头端帽13的近端设计一个定位柱结构，从而将头端帽13插入头端管12后，再用螺纹连接、卡勾连接、焊接、压接等连接方式进行固定。
本实施例中，头端帽13可以通过螺纹、卡扣、焊接等方式与头端管12相连接，将前端固定件分成两个部件，即头端帽13和头端管12。其中，头端帽13前端加工成圆锥体并倒圆，该形状具有良好的导向作用，能够保证网篮部1顺利穿过内镜并进入人身体内，并且对内镜以及人体器官不会造成伤害。本申请省去传统取石网篮的铆接或者焊接工艺，尤其是避免镍钛丝和不锈钢难以焊接的难题，从而能够最大限度地保证取石网篮丝的连接力以及插入身体时的顺畅性。
在本申请的部分实施例中，如图10、图11所示，多根所述网篮丝11中的一根或多根网篮丝11上设有收窄部；所述收窄部的横截面积小于所述网篮丝11上非收窄部的横截面积，以降低所述收窄部的抗拉强度。即本申请的网篮丝11中，存在一根或多根网篮丝11，通过磨削将其部分段的直径磨窄，使其截面变小，降低抗拉强度。实际使用中，如果出现结石嵌顿，可以通过使用碎石器等工具，将网篮丝11磨窄的部分拉断后释放结石。为了保持有一定的抗拉强度，本申请不采用将所有的网篮丝11都设有收窄部，所述收窄部可以在网篮丝11的远端或近端，也可以在网篮丝11的中部。
本申请通过至少有一根网篮丝11，具有收窄部，以获得不同段，不同的截面积，从而使截面积小的部分抗拉强度低，截面积大的部分抗拉强度高。如图12所示，在取石过程中，如果发生结石嵌顿，网篮丝11受力时，其中有收窄部的网篮丝11会先断裂，使得结石被释放出来，确保器械可以顺利退出。另外，还可以设计将至少有一根丝的强度高于其他几根丝的，确保网篮丝断裂后，至少有一根网篮丝11和头端帽13连在一起，防止头端帽13掉落在人体内。
为了实现在网篮部1与操作丝2之间的连接，在本申请的部分实施例中，如图13所示，所述网篮部1还包括从远端向近端方向，依次设置在所述操作丝2上的收紧管14、连接管15以及助推管16；所述收紧管14通过圆管结构，将网篮丝11的近端收拢；所述操作丝2通过所述连接管15以及助推管16连接所述网篮丝11的近端。进一步地，所述收紧管14、连接管15以及助推管16两端为斜角结构。
本实施例中，网篮部1整体可以包括牵引部分和取石部分，其中取石部分即上述网篮丝11、头端管12以及头端帽13，以通过网篮丝11的张开和收拢，抓取患者体内的异物。网篮部1的牵引部分，可以由一根不锈钢绳索和不锈钢助推管16组成。不锈钢绳索可以提供良好的推送性能和过弯性能，以便驱动网篮部1的取石部分进行运动。网篮丝11的近端可以使用收紧管14进行收拢，并采用连接管15实现连接。为了减小断面落差，所述收紧管14、连接管15以及助推管16的两端为斜角结构,斜角结构可以使网篮部1可以在导管3内顺畅移动。
本申请提供的取物器械，在进行手术时，通过操作近端，使网篮部1能够从导管3中推出和收拢。因此，为了便于进行控制，在本申请的部分实施例中，所述取物器械还包括手柄4，实施手术的人员可以通过操纵手柄4，产生对应的动作，如推送、拉伸、旋转等。所述手柄4包括前手柄41和后手柄42。其中，所述后手柄42通过所述前手柄41连接所述导管3的近端；所述后手柄42连接所述操作丝2，根据上述牵引部分，后手柄42可以连接操作丝2上的助推管16，以通过推拉所述后手柄42操纵所述网篮部1，使所述网篮部1伸出或收回导管3。另外，在本申请提供的技术方案中，可以将导管3配合护套管，前手柄，锁紧螺母，后手柄等部件组装，完成最终的取物器械产品。
进一步地，所述导管3内还设有注液腔道；所述前手柄41上设有连通所述注液腔道的鲁尔接头。前手柄41上设置的鲁尔接头可以与导管3内的注液腔道相连，注液腔道一直到延伸到远端的网篮部1，从而形成一个完整的注液通道，在实际手术中，可用于向病灶为止输送药剂、清洗试剂等，以辅助完成手术。
本申请提供的取物器械，可以用于在体内腔道进行取物手术，例如，消化道、十二指肠、胆管、胰管等。其中，对于消化道，其腔道趋于平缓，取物器械很容易到达或在内镜腔道的疏导下到达病灶位置。而对于胆管或胰管等细小的腔道，取物器械需要经过复杂的路径才能够进入胆管或胰管内。为了到达胆管或胰管内，需要通过导丝对取物器械的行进路径进行引导。因此，在本申请提供的部分实施例中，所述导管3的远端还设有双腔端帽31，双腔端帽31可以与导丝配合，使导管3的远端可以沿着导丝行进。
相应的，如图14所示，所述双腔端帽31包括两个腔道，其中一个腔道连通所述导管3的内腔，用于通过所述网篮部1，另一个腔道用于通过导丝；所述双腔端帽31的远端端面为倾斜结构。本实施例中，导管3的远端设有一个双腔端帽31。双腔端帽31的一个腔道可以过网篮部1，另一个腔道可以过导丝。通过腔道在导丝上的滑动，可以使导管3的远端能够沿着导丝行进，进入到病灶位置。
双腔端帽31的远端端面可以为双腔部，近端端面可以为仅通过网篮部1的单腔部，实际应用中，单腔部一方面可以用于通过网篮部1，另一方面还用于连接导管3的远端，单腔部和双腔部可以为一体结构。为了便于通过患者体内腔道，减少双腔部与腔道壁的组织之间剐蹭，划伤组织内壁，在双腔部远端端面的导丝腔道一侧，还设有导向斜角结构。而为了节省内镜中的腔道空间，在双腔端帽31的双腔部中，用于通过网篮部1的外轮廓宽度大于用于通过导丝部分的外轮廓宽度。
由以上技术方案可知，对比现有的取石网篮，本申请提供的微创手术取物器械，采用头端管12穿网篮丝11的结构，网篮丝11与头端管12之间的连接强度，就是网篮丝11本身的抗拉强度。因此，本申请提供的取物器械可以省去传统的铆接或者焊接工艺，尤其 避免在镍钛丝和不锈钢之间进行焊接，改善焊接、压接结构的不稳定性。
进一步地，本申请提供的取物器械，通过在头端管12前端安装圆锥状的头端帽13，可以通过头端帽13具有远端窄，近端宽的结构，实现更加有效的穿过十二指肠乳头和胆管结石间的间隙，以适应复杂的患者内腔道环境。本申请还在导管3的远端安装可过导丝的双腔端帽31，可以在取石前使用其他器械预置导丝后，再将取物器械在预置导丝引导下快速到达病灶位置。本申请在网篮部1的连接管15和收紧管17的两端做斜角处理，以减小断面落差，使网篮部1可以在外管内顺畅移动。
另外，本申请提供的取物器械还通过将至少有一根网篮丝11上，设置具有不同的截面积的收窄部，截面积变小的收窄部强度低，而截面积大的非收窄部的强度大。可以在取石过程中，发生结石嵌顿、网篮丝11受力时，收窄部会先断裂，使得结石被放出来，确保器械可以顺利退出。
本申请提供的实施例之间的相似部分相互参见即可，以上提供的具体实施方式只是本申请总的构思下的几个示例，并不构成本申请保护范围的限定。对于本领域的技术人员而言，在不付出创造性劳动的前提下依据本申请方案所扩展出的任何其他实施方式都属于本申请的保护范围。

Claims (10)

  1. 一种微创手术取物器械，其特征在于，包括：
    导管(3)；
    网篮部(1)，连接所述导管(3)的远端；
    其中，所述导管(3)中设有连接所述网篮部(1)的操作丝(2)；所述网篮部(1)包括多根网篮丝(11)以及头端管(12)；
    所述头端管(12)为包括至少两个腔道的多腔管结构；每一根所述网篮丝(11)的一端从所述头端管(12)的一个腔道穿过后，再从所述头端管(12)的另一个腔道穿回，使所述网篮丝(11)的两端经回折后连接所述操作丝(2)；所述网篮丝(11)定型为弯曲结构。
  2. 根据权利要求1所述的取物器械，其特征在于，所述网篮部(1)还包括头端帽(13)，所述头端帽(13)连接所述头端管(12)的远端；所述头端帽(13)的远端为圆弧过渡结构。
  3. 根据权利要求2所述的取物器械，其特征在于，所述头端帽(13)为远端直径小于近端直径的圆锥体结构；
    所述头端帽(13)的近端设有螺纹或卡勾，所述头端管(12)上设有螺纹或卡槽，以使所述头端帽(13)通过螺纹或卡勾，连接所述头端管(12)的远端。
  4. 根据权利要求1所述的取物器械，其特征在于，多根所述网篮丝(11)中的一根或多根网篮丝(11)上设有收窄部；
    所述收窄部的横截面积小于所述网篮丝(11)上非收窄部的横截面积，以降低所述收窄部的抗拉强度。
  5. 根据权利要求1所述的取物器械，其特征在于，所述网篮部(1)还包括从远端向近端方向，依次设置在所述操作丝(2)上的收紧管(14)、连接管(15)以及助推管(16)；
    所述收紧管(14)通过圆管结构，将网篮丝(11)的近端收拢；所述操作丝(2)通过所述连接管(15)以及助推管(16)连接所述网篮丝(11)的近端。
  6. 根据权利要求5所述的取物器械，其特征在于，所述收紧管(14)、连接管(15)以及助推管(16)两端为斜角结构。
  7. 根据权利要求1所述的取物器械，其特征在于，所述取物器械还包括手柄(4)，所述手柄(4)包括前手柄(41)和后手柄(42)；
    所述后手柄(42)通过所述前手柄(41)连接所述导管(3)的近端；所述后手柄(42)连接所述操作丝(2)，以通过推拉所述后手柄(42)操纵所述网篮部(1)，使所述网篮部(1)伸出或收回导管(3)。
  8. 根据权利要求7所述的取物器械，其特征在于，所述导管(3)内还设有注液腔道；所述前手柄(41)上设有连通所述注液腔道的鲁尔接头。
  9. 根据权利要求1所述的取物器械，其特征在于，所述导管(3)的远端还设有双腔端帽(31)；
    所述双腔端帽(31)包括两个腔道，其中一个腔道连通所述导管(3)的内腔，用于通过所述网篮部(1)，另一个腔道用于通过导丝；所述双腔端帽(31)的远端端面为倾斜结构。
  10. 根据权利要求1所述的取物器械，其特征在于，多根所述网篮丝(11)通过连接在所述头端管(12)的远端，形成一束延伸方向与导管(3)轴向相同的并排结构。
PCT/CN2019/127039 2019-12-20 2019-12-20 一种微创手术取物器械 WO2021120178A1 (zh)

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