WO2021077955A1 - 一种手术缝合训练器 - Google Patents

一种手术缝合训练器 Download PDF

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Publication number
WO2021077955A1
WO2021077955A1 PCT/CN2020/115889 CN2020115889W WO2021077955A1 WO 2021077955 A1 WO2021077955 A1 WO 2021077955A1 CN 2020115889 W CN2020115889 W CN 2020115889W WO 2021077955 A1 WO2021077955 A1 WO 2021077955A1
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training
needle
base
suture
track
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PCT/CN2020/115889
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French (fr)
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程庆
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海口市人民医院
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    • G—PHYSICS
    • G09—EDUCATION; CRYPTOGRAPHY; DISPLAY; ADVERTISING; SEALS
    • G09B—EDUCATIONAL OR DEMONSTRATION APPLIANCES; APPLIANCES FOR TEACHING, OR COMMUNICATING WITH, THE BLIND, DEAF OR MUTE; MODELS; PLANETARIA; GLOBES; MAPS; DIAGRAMS
    • G09B23/00—Models for scientific, medical, or mathematical purposes, e.g. full-sized devices for demonstration purposes
    • G09B23/28—Models for scientific, medical, or mathematical purposes, e.g. full-sized devices for demonstration purposes for medicine

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  • the invention belongs to the technical field of medical training equipment, and relates to a training equipment for surgical operations, in particular to a training device for suturing under simulating surgical conditions such as different angles, positions, and needle movement trajectories.
  • Suture is one of the four basic skills of surgical techniques, and it is the most difficult technique to master. Surgery is usually divided into destructive surgery of simple resection, anatomical reconstruction surgery and functional reconstruction surgery, and the difficulty and requirements are gradually increasing. The latter two require superb suture skills, and the quality of the suture technology directly affects the effect of this type of surgery. In the first type of resection surgery, the biggest difficulty is hemostasis, and the most difficult part of hemostasis is also to be completed by sutures. Therefore, suture is the most important technique in surgery. On the other hand, suturing is also the most difficult part of the operation, especially in the suturing of insufficiently exposed deep tissues and endoscopic suturing in minimally invasive surgery.
  • the difficulty of suturing is to use needles with different arcs to make the trajectory in the tissue conform to the anatomical and physiological characteristics of the tissue, that is, use a needle with a fixed arc to sew a specific trajectory, such as straight lines and irregularities.
  • the arc or other shape, and the needle also needs to be curved in order to meet the needs of the organization and the actual situation in the operation.
  • these tissues are well exposed and located at the center position parallel to the operation centerline, and the stitching track is the most regular arc, the stitching is the easiest to complete, which is also the setting scene of the usual stitching trainer.
  • the difficulty increases to varying degrees.
  • the difficulty of suturing under laparoscopic surgery is one step more difficult. Because the position of the operation hole is fixed, the needle holding instrument is fixed at one point during suturing, and the operation can only be carried out with this point as the center. The needle movement is subject to stricter restrictions and the difficulty of suturing is extremely increased. In the early laparoscopic surgery, each stitch took about half an hour and required special equipment to assist. Even with today’s most advanced robot-assisted laparoscopy, although the machine itself can carry out needle transport in three-dimensional space and can achieve a needle transport mode similar to open surgery under minimally invasive conditions, the machine still requires human operation, so it also needs to be operated. Training can be well mastered.
  • the quality of the completion of the operation is often limited by the quality of the completion of the suture, especially in reconstructive surgery, especially in endoscopic reconstruction surgery.
  • Poorly completed sutures will cause serious consequences such as tissue tears, narrow ducts, urine leakage, intestinal fistulas, and pancreatic fistulas.
  • people usually only pay attention to whether the operation is completed, and the quality of the completion is usually hidden, because sutures can always be completed, but the quality of sutures that can be completed varies greatly, but it is extremely important for the operation and the patient.
  • the suturing learning curve is an important part of the surgery learning curve, and the effect of the surgery performed and the patient's recovery are directly affected by the suturing technology.
  • suture links In the existing suture training system, there are suture links, but there is no specially designed suture training device.
  • gauze, latex, etc. are usually used to sew in a straight line or diagonal line.
  • the degree of simulation is suturing under the simplest conditions, which differs greatly from the actual requirements during surgery.
  • the current training methods lack complex needle adjustments and severely inadequate intraoperative simulations, lack of training in the three-dimensional operation of the needle holder, needle clamping at various angles, and fine control of needle adjustment, resulting in
  • the trainer's lack of grasping of the operation of the needle holder by the arms and wrists and the lack of fine control of needle clamping, needle adjustment, needle movement and needle ejection at various angles of the training suture needle makes it difficult for the effect of suture training to meet the complex requirements of the operation.
  • the purpose of the present invention is to provide a surgical suture training device in view of the shortcomings of the prior art, which has a simple structure and is convenient to use.
  • needle paths with different shapes and inner diameters are designed and can be simulated. Needle movement trajectories under different angles and positions, and different levels of difficulty are suitable for different training stages, effectively helping surgeons at different stages to carry out targeted training.
  • a surgical suture trainer includes at least one training unit.
  • the training unit includes a needle track, a base, and a connecting seat.
  • the needle track is used to train the trainer in stitching, such as needle clamping, needle insertion, needle transport, and needle ejection.
  • the needle track is fixed on the base, the connecting seat is arranged under the base, and the connecting member is arranged on the connecting seat.
  • the connecting seat is used to connect and fix the training unit (base) to the training platform (such as the fixed platform or the training system Adjusting platform), different connection methods or connecting parts can make the training unit show different directions, positions and angles, so that the training unit can adjust the position and angle in the three-dimensional space arbitrarily, so as to simulate the shape of human organs and different intraoperative
  • the suture conditions are conducive to improving the quality of the suture training of the surgeon.
  • the connecting member is a connecting piece used to connect the connecting seat to the training platform. It has a variety of structural forms, such as opening a fixed hole of a specific shape on the connecting seat (such as Gear-shaped fixing holes).
  • the training platform is provided with a correspondingly shaped boss (such as a gear-shaped fixing rod).
  • connection members are conventional technologies in the mechanical field, so I won’t discuss them one by one here.
  • Different training units have different needles.
  • the shape and inner diameter of the path are different.
  • the shape of the needle path has many forms, such as a regular arc, an irregular arc, and even an "L" shape.
  • the number of needle tracks provided on the base is one or more, and the shape of the needle tracks is the same or different.
  • the simple suture conditions in the operation can be simulated for training.
  • the shape of the base should be adjusted accordingly to simulate the shape of different tissues and organs, such as a round shape similar to the intestine, or other shapes similar to various parts or organs of the human body, so that the multiple needle paths can be adjusted to a certain degree.
  • the shapes are combined to form a combined training unit, in which the shape of multiple needle tracks can be the same or different.
  • the needle track is a soft body or a net-like structure, and is made of a soft material or a net-like material, which facilitates the repeated puncture of the suture needle.
  • the needle track is wrapped with a hard track, which can restrict the movement of the suture needle, avoid penetrating the needle track and affect training, and can also support the needle track.
  • the needle track and the hard track are transparent bodies made of transparent materials, which facilitates the observation of the movement of the needle.
  • the base is a semi-rigid structure and is made of semi-rigid materials, so that the training unit has a certain degree of flexibility and mobility, and can be pulled during suture training, simulating the state of tissues near the suture site being pulled during intraoperative suture. , Is conducive to improving the training effect.
  • the connecting base is a hard structure, which is beneficial to connect and fix the training unit on other platforms.
  • the present invention is simple in structure and convenient to use, the needle path is variable, the inner diameter is variable, and it can highly simulate the morphological characteristics and suture requirements of the tissue to be sutured during the operation, but this design is not available in the existing training system.
  • the training device can be adjusted in two-dimensional and three-dimensional space, so that it can fully simulate the suture angle in the operation, especially the suture training of the difficult angle, and solve the problem.
  • a training system only simulates the suture environment under simple conditions, and it is difficult to simulate the difficult (different angles, positions, needle trajectories) suture training under complex conditions, which can effectively improve the training effect, shorten the learning curve, and reduce surgical complications. Improve the quality of surgery.
  • Figure 1 is a schematic diagram of the structure of the first embodiment
  • FIG. 2 is a schematic diagram of the top view structure of the first embodiment
  • Figure 3 is a schematic view of the bottom structure of the first embodiment
  • FIG. 4 is a schematic diagram of a side view of the structure of this embodiment.
  • FIG. 5 is a schematic diagram of the top view structure of the combined base of the second embodiment
  • Fig. 6 is a schematic side view of the structure of the circular combination of multiple needle tracks in the second embodiment.
  • the surgical suture training device includes at least one training unit, the training unit includes a needle track 1, a base 3 and a connecting seat 4, the needle track 1 Designed as a curved arc structure and fixed on the base 3, the connecting seat 4 is arranged below the base 3, and a gear-shaped fixing hole 5 (connecting member) is opened on the connecting seat 4;
  • the inner diameter is variable, for example, the shape can be changed from a regular arc to an irregular arc, or even an L shape, so that various difficult needle handling and needle ejection training can be carried out.
  • the training platform (such as the fixed platform or the adjustment platform in the training system) is provided with a gear-shaped fixed rod of corresponding shape, and the fixed rod is embedded in the fixed hole 5 to realize the connection and fixation of the connecting seat 4 and the training platform and present Its form.
  • the position can be adjusted in a two-dimensional space.
  • the training unit can be at different positions and angles. Then the adjustment of the three-dimensional space can be realized.
  • the change in the shape of the needle path 1 and the adjustment of its spatial position can highly simulate the difficulty of intraoperative suture.
  • the needle track 1 and the hard track 2 can be made of corresponding transparent materials, which is beneficial to observe the movement track of the training suture needle and make timely adjustment and experience.
  • the needle track 1 of the training unit can be combined in a certain shape to simulate the shape of various tissue structures, such as a circular simulated intestine as an example, as shown in Fig. 5 and Fig.
  • the surgical suture training device includes a combined base 6 and a combined connecting base 7.
  • the combined connecting base 7 is arranged at the bottom of the combined base 6.
  • the combined base 6 is designed in a circular structure according to the shape of the intestine, and several needle tracks 1 are installed in the circumferential direction.
  • the needle track 1 is wrapped in the hard track 2, so that a plurality of needle tracks 1 are combined into a circular structure, which can be used to simulate the intestine.
  • the walking shape and inner diameter of the needle track 1 can be the same or different, and the combined base 6 is also made of semi-hard material, and the shape depends on the combined shape, and continues to the combined connecting seat 7 downward.
  • the combined connecting seat 7 is completely the same as the connecting seat 4 described in the first embodiment, and the combined connecting seat 7 is made of hard material.
  • connection and adjustment methods of the combined connecting seat 7 and the fixing hole 5 are the same as those in the first embodiment, which can realize the position and angle adjustment in the three-dimensional space. As a result, it can further imitate the surgical scene and the difficulty of suture during the operation, effectively improve the training effect of suture, shorten the learning curve, and help improve the quality of suture training for surgeons.

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Abstract

一种手术缝合训练器，包括至少一个训练单元，训练单元包括针道（1）、底座（3）和连接座（4），针道（1）固定于底座（3）上，连接座（4）设置于底座（3）下方，在连接座（4）上设置有连接构件（5）；不同的训练单元，其针道（1）的走形和内径均不相同。该训练器通过针道（1）和底座（3）的配合设计，模拟人体器官形态和术中不同的缝合条件，有效保证训练单元可在二维空间或三维空间内任意调整位置和角度，达到高度模拟术中的缝合要求，最大限度保护组织，提升缝合效果，从而有效提升训练效果，缩短学习曲线，降低手术并发症，提升手术完成质量。

Description

一种手术缝合训练器 技术领域
本发明属医疗训练器械技术领域，涉及一种外科手术的训练器材，具体是一种模拟不同角度、位置和运针轨迹等手术条件下进行缝合的训练器。
背景技术
缝合是手术技巧的四个基本功之一，而且是最难掌握的技巧。通常把手术分为单纯切除的破坏性手术、解剖重建类手术和功能重建类手术，难度和要求逐渐递增。其中后两者都要求高超的缝合技巧，缝合技术的完成质量，直接影响该类手术的效果。而在第一类切除类手术中，最大的难点是止血，而止血当中最困难的，也是需要通过缝合来完成。因此，缝合是手术中最重要的技巧。另外一面，缝合也是手术中最难学习的一个环节，特别在暴露不足深部组织的缝合和微创手术中腔镜下的缝合。
究其根本，缝合的难点在于要运用不同弧度的针，使其在组织内的运行轨迹需要符合组织的解剖生理特点，也就是用固定弧度的针，缝合出特定的轨迹，比如直线，不规则弧线或其它走形，同时出针也需要顺弧度，以符合组织的需求和术中的实际。当这些组织显露良好，且位于和操作中心线平行的中心位置，缝合轨迹为最规则的弧形时，缝合是最容易完成的，这也是通常的缝合训练器设置的场景。当目标缝合的组织的空间位置变化，并且和操作器械之间受到各种器官组织阻碍时，难度不同程度加大。
腹腔镜手术下的缝合难度更近一步加大。因为操作孔位固定，使得缝合时持针器械固定于一点，只能以该点为中心进行操作，运针受到更严格的限制，缝合难度极度加大。早期的腹腔镜手术中，每一针缝合大约需要半小时，并且需要特殊器械辅助。即便是当今最高级的机器人辅助腹腔镜，虽然机器本身可以进行三维空间的运针，可以实现微创条件下的类似于开放手术的运针模式， 但机器仍然需要人进行操作，因此同样需要进行训练，才能很好的掌握。
由在，手术的完成质量往往受限于缝合的完成质量，特别是在重建类手术，尤其是腔镜下的重建类手术。比如肾部分切除术的缝合、前列腺癌根治术的尿道重建、输尿管膀胱再植、肾盂成型、胆管肠管吻合、胰管吻合等。完成不良的缝合将造成组织撕裂、管道狭窄、漏尿、肠瘘、胰瘘等严重后果。尤其，通常人们只关注手术是否完成，而完成质量则通常比较隐蔽，因为缝合通常总是可以完成的，可缝合的完成质量却有巨大差别，但又对手术、患者又极为重要。
由此，对外科医师而言，其缝合的学习曲线是手术学习曲线的重要一环，其施行的手术的效果和患者的愈后受缝合技术的直接影响。现有的缝合训练体系中，有缝合的环节，但没有专门设计的缝合训练器。正如前述，通常是采用纱布、乳胶体等，摆成直线或斜线，进行缝合。其模拟度为最简单条件下的缝合，和术中实际需求相差巨大。
具体来说，目前的训练方法缺乏复杂的夹针调针，对术中情况模拟严重不足，缺乏持针器的三维空间运行、各种角度夹针、调针的精细控制等方面的训练，导致训练者缺乏手臂、手腕对持针器运行的掌握和缺乏训练缝合针各种角度夹针、调针以及运针、出针的精细控制，使得缝合训练效果难以符合术中的复杂要求。
发明内容
本发明的目的是针对现有技术的不足而提供一种手术缝合训练器，结构简单，使用方便，针对外科手术缝合的难点和要点，设计了不同走形和内径的针道，并可模拟出不同角度、位置下的运针轨迹，不同的难度适用于不同的训练阶段，有效帮助不同阶段的外科医师进行针对性的训练。
本发明所采用的技术方案：
一种手术缝合训练器，包括至少一个训练单元，所述训练单元包括针道、底座和连接座，针道用于对训练者进行夹针、进针、运针、出针等缝合环节的训练，针道固定于底座上，连接座设置于底座下方，在连接座上设置有连接构 件，连接座用于将训练单元(底座)连接并固定到训练平台上(如固定平台或训练体系中的调节平台)，不同的连接方式或连接部位均可使训练单元呈现出不同的方向、位置和角度，使训练单元可在三维空间里任意调整位置和角度，从而模拟人体器官形态和术中不同的缝合条件，有利于提升外科医师的缝合训练质量，连接构件是用于将连接座连接到训练平台上的连接件，其结构形式多种多样，如在连接座上开设特定形状的固定孔(如齿轮状固定孔)，相应地，在训练平台上设置有相应形状的凸台(如齿轮状固定棒)，将凸台嵌入固定孔中即可实现底座与训练平台的连接和固定，训练平台上不同凸台、不同的连接方向均可使训练单元处于不同的位置和角度，等等，无论如何，连接构件均属机械领域常规技术，在这里就不一一论述；不同的训练单元，其针道的走形和内径均不相同，针道的走形有多种形式，比如规则弧形、不规则弧形，甚至为“L”形。
较佳地，所述底座上设置的针道的数量为一个或多个，针道的走形相同或不相同，底座上设置一个针道时，可模拟术中简单的缝合条件进行训练，底座上设置多个针道时，底座的形状应进行相应调整，以模拟不同组织器官的形态，比如类似肠管的圆形，或者其他类似人体各种部位或器官的形态，使多个针道按一定形状进行组合，形成组合式训练单元，其中多个针道的走形可以相同或不同。
较佳地，所述针道为软质体或网状结构，采用软质材料或网状材料制作，利于缝合针的反复穿刺。
较佳地，所述针道外包绕有硬质轨道，即可限制缝合针的运行，避免穿透针道，影响训练，也可对针道起到承托的作用。
较佳地，所述针道和硬质轨道为透明体，采用透明材料制成，利于观察针的运行。
较佳地，底座为半硬质结构，采用半硬质材料制成，使得训练单元有一定弹性和活动度，可在缝合训练时被拉动，模拟术中缝合时缝合部位附近组织被拉动的状态，有利于提高训练效果。
较佳地，所述连接座为硬质结构，有利于将训练单元连接并固定在其他平 台上。
与现有技术相比，本发明的有益效果是：
1、本发明结构简单，使用方便，针道走形可变、内径可变，可高度模拟术中需缝合组织的形态特点及缝合要求，而在现有的训练体系中不具备这种设计。
2、结合底座、连接座，配合训练体系的调节装置，可使训练器在二维、三维空间里调整位置，因而可充分模拟术中的缝合角度，特别是困难角度的缝合训练，解决了现有训练体系只是模拟简单条件下的缝合环境、难以模拟复杂条件下进行高难度(不同角度、位置、运针轨迹)缝合训练的难题，可以有效提升训练效果，缩短学习曲线，降低手术并发症，提升手术完成质量。
附图说明
图1为本实施例一结构示意图；
图2为本实施例一俯视结构示意图；
图3为本实施例一仰视结构示意图；
图4为本实施例一侧视结构示意图；
图5为本实施例二组合底座俯视结构示意图；
图6为本实施例二多个针道圆形组合侧视结构示意图。
图中：1、针道；2、硬质轨道；3、底座；4、连接座；5、固定孔；6、组合底座；7、组合连接座。
具体实施方式
下面通过实施例并结合附图对本发明作进一步说明，但不作为对本发明的限定。
实施例一
如图1、图2、图3、图4所示，本发明所提供的手术缝合训练器，包括至少一个训练单元，所述训练单元包括针道1、底座3和连接座4，针道1设计为弯弧状结构并固定于底座3上，连接座4设置于底座3下方，在连接座4上开设齿轮状固定孔5(连接构件)；不同的训练单元，其针道1的走形和内径可变，比如走形可从规则的弧形到不规则的弧形，甚至L形，由此可进行各种难度的 运针和出针的训练。
在训练平台(如固定平台或训练体系中的调节平台)上设置有相应形状的齿轮状固定棒，将固定棒嵌入固定孔5中即可实现连接座4与训练平台的连接和固定并呈现出其形态。通过调整固定孔5的孔位和在固定棒上的位置，可实现在二维空间调整位置，当固定棒与训练体系的固定位置和角度调整时，可使训练单元处于不同的位置和角度，即可实现三维空间的调整。针道1走形的变化，配合其空间位置的调整，可高度模拟术中的缝合难度。
在实施本发明时，可采用相应的透明材料制作成针道1和硬质轨道2，有利于观察训练缝合针的运动轨迹和进行及时的调整与体会。
实施例二
本发明所提供的手术缝合训练器，其训练单元的针道1可以由多个按一定形状进行组合，以模拟各种组织结构的形态，比如以圆形模拟肠管为例，如图5、图6所示，手术缝合训练器包括组合底座6和组合连接座7，组合连接座7设置在组合底座6底部，组合底座6依据肠管形态设计为圆形结构，在圆周向上安装数个针道1，针道1包绕在硬质轨道2中，由此，由多个针道1组合成圆形结构，可用以模拟肠管。其针道1的走形和内径可相同或不同，其组合底座6也采用半硬质材料，外形依组合的形状而定，向下续于组合连接座7。组合连接座7完全同实施例一所述的连接座4，组合连接座7为硬质材料。
组合连接座7、固定孔5的连接和调节方式同实施例一，可实现三维空间的位置和角度调整。由此，可进一步模仿术中的手术场景，以及缝合难度，有效提高缝合的训练效果，缩短学习曲线，有利于提升外科医师的缝合训练质量。
以上所述仅是本发明的优选实施方式，应当指出，对于本技术领域的普通技术人员来说，在不脱离本发明技术原理的前提下，还可以做出若干改进和润饰，这些改进和润饰也应视为本发明的保护范围。

Claims (7)

  1. 一种手术缝合训练器，其特征在于：包括至少一个训练单元，所述训练单元包括针道、底座和连接座，针道固定于底座上，连接座设置于底座下方，在连接座上设置有连接构件；不同的训练单元，其针道的走形和内径均不相同。
  2. 根据权利要求1所述的手术缝合训练器，其特征在于：所述底座上固定的针道的数量为一个或多个，多个针道可按一定形状进行组合，针道的走形相同或不相同。
  3. 根据权利要求1所述的手术缝合训练器，其特征在于：所述针道为软质体或网状结构。
  4. 根据权利要求1所述的手术缝合训练器，其特征在于：所述针道外包绕有硬质轨道。
  5. 根据权利要求1所述的手术缝合训练器，其特征在于：所述针道和硬质轨道为透明体。
  6. 根据权利要求1所述的手术缝合训练器，其特征在于：所述底座为半硬质结构。
  7. 根据权利要求1所述的手术缝合训练器，其特征在于：所述连接座为硬质结构。
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