WO2020015692A1 - 一种牵引装置以及用于牵引装置的牵拉环 - Google Patents

一种牵引装置以及用于牵引装置的牵拉环 Download PDF

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Publication number
WO2020015692A1
WO2020015692A1 PCT/CN2019/096455 CN2019096455W WO2020015692A1 WO 2020015692 A1 WO2020015692 A1 WO 2020015692A1 CN 2019096455 W CN2019096455 W CN 2019096455W WO 2020015692 A1 WO2020015692 A1 WO 2020015692A1
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Prior art keywords
traction
clamping
closed
elastic
lesion
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PCT/CN2019/096455
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English (en)
French (fr)
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冀明
双建军
沈正华
李常青
冷德嵘
刘春俊
胡洁
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南微医学科技股份有限公司
首都医科大学附属北京友谊医院
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Application filed by 南微医学科技股份有限公司, 首都医科大学附属北京友谊医院 filed Critical 南微医学科技股份有限公司
Priority to DE212019000166.1U priority Critical patent/DE212019000166U1/de
Priority to JP2020600115U priority patent/JP3232938U/ja
Priority to ES202090045A priority patent/ES2817674R1/es
Publication of WO2020015692A1 publication Critical patent/WO2020015692A1/zh
Priority to US17/089,369 priority patent/US11925343B2/en

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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
    • A61B17/0293—Surgical instruments, devices or methods, e.g. tourniquets for holding wounds open; Tractors with ring member to support retractor elements
    • 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
    • A61B17/0218—Surgical instruments, devices or methods, e.g. tourniquets for holding wounds open; Tractors for minimally invasive surgery
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B10/00—Other methods or instruments for diagnosis, e.g. instruments for taking a cell sample, for biopsy, for vaccination diagnosis; Sex determination; Ovulation-period determination; Throat striking implements
    • A61B10/02—Instruments for taking cell samples or for biopsy
    • A61B10/04—Endoscopic instruments
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/00234—Surgical instruments, devices or methods, e.g. tourniquets for minimally invasive surgery
    • 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
    • A61B17/0206—Surgical instruments, devices or methods, e.g. tourniquets for holding wounds open; Tractors with antagonistic arms as supports for retractor elements
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/00234—Surgical instruments, devices or methods, e.g. tourniquets for minimally invasive surgery
    • A61B2017/00238—Type of minimally invasive operation
    • A61B2017/00269—Type of minimally invasive operation endoscopic mucosal resection EMR
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/00234—Surgical instruments, devices or methods, e.g. tourniquets for minimally invasive surgery
    • A61B2017/00292—Surgical instruments, devices or methods, e.g. tourniquets for minimally invasive surgery mounted on or guided by flexible, e.g. catheter-like, means
    • A61B2017/0034—Surgical instruments, devices or methods, e.g. tourniquets for minimally invasive surgery mounted on or guided by flexible, e.g. catheter-like, means adapted to be inserted through a working channel of an endoscope
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B2017/00831—Material properties
    • A61B2017/00862—Material properties elastic or resilient
    • 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
    • A61B17/0218—Surgical instruments, devices or methods, e.g. tourniquets for holding wounds open; Tractors for minimally invasive surgery
    • A61B2017/0225—Surgical instruments, devices or methods, e.g. tourniquets for holding wounds open; Tractors for minimally invasive surgery flexible, e.g. fabrics, meshes, or membranes
    • 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
    • A61B2017/0287—Surgical instruments, devices or methods, e.g. tourniquets for holding wounds open; Tractors with elastic retracting members connectable to a frame, e.g. hooked elastic wires

Definitions

  • the invention relates to a traction device and a pulling ring for the traction device in the field of medical instruments, and in particular, to a traction device that has good elasticity, does not require external force, and can rely on the elasticity of the traction portion to achieve traction of a cutting lesion.
  • the surgical field of view is fully exposed; at the same time, a large wound can be pulled to reduce the traction device for further clamping of the wound.
  • EMR endoscopic mucosal section
  • EMR endoscopic mucosal section
  • gastrectomy was the only treatment for early gastric cancer, and currently this treatment has been widely used.
  • Endoscopic submucosal dissection refers to the use of a modified needle knife under the endoscope to directly strip the mucosa from the submucosa. It evolved from the mucosal resection EMR because of its high resection rate and safety. Good sex, expand the indications for early digestive tract cancer and other tumor resections, and gradually become a widely accepted minimally invasive surgical treatment.
  • ESD and EMR achieve resection of the lesion with a common single-channel endoscope, and avoid the pain of open surgery and resection of organs.
  • the disadvantage of EMR is that this technique cannot remove large lesions in one piece. The fragmented specimens removed are difficult to perform detailed pathological analysis, the tumor stage is not clear, and there is a high risk of tumor recurrence.
  • ESD has 1, less trauma, 2, patients can receive multiple treatments at multiple sites, 3, and enables doctors to obtain complete histopathological specimens for analysis. 4.
  • Tumors with large areas and irregular shapes or with ulcers and scars undergo a resection rate of more than 96% to reduce the probability of recurrence.
  • ESD has a longer operating time, is more risky, and is more difficult to operate than EMR.
  • the operation time of EMR is about 20 minutes, and the operation time of most ESD is 60-90 minutes.
  • There are complications such as bleeding, perforation, stenosis and postoperative infection, which is not conducive to large-scale promotion and application.
  • the main steps of ESD surgery are: marking, submucosal injection, marginal incision, peeling, and wound management.
  • the wire is not elastic. After cutting a part of the lesion, the wire may lose its effect, unable to continue pulling the lesion, and the cutting process cannot be performed smoothly.
  • Metal clip elastic ring combined with traction technology, the size of the elastic ring is limited, the O-ring needs to be tied to the clip with a silk thread, and a special outer sheath is also used, which is cumbersome to operate and brings inconvenience to the user.
  • S-O metal clip traction technology based on the spring, metal clip and nylon coil design a kind of in vivo traction technology. This method is derived from the combination of the metal clip elastic ring and the traction method. It replaces the elastic ring with a spring, and strives to obtain greater flexibility to adapt to ESD resection of large, superficial early colon tumors.
  • Magnetic anchor traction technology requires special equipment, such as equipped with a standard retractable arm, to continuously change the direction of traction outside the body, the operation is tedious, and during the operation, if the number of magnets is large, it will hinder the vision of the operation.
  • the traction device of the present invention is composed of a clamping portion and a traction portion.
  • the traction portion relies on its own elastic force and elastic deformation and extension can provide traction force in the body to pull the lesion and fully expose the surgical field of vision. Because it does not need to provide external force, it is not limited by the anatomical location and the size of the lumen of the digestive tract. It can be used for traction of mucous membranes, tissues, and organs. It is especially suitable for difficult positions in ESD surgery, allowing doctors to be more intuitive and visible The operation of mucosal dissection can make the operation safer and easier, which can greatly shorten the operation time and reduce the patient's pain. It is suitable for large-area lesion dissection.
  • Commonly used digestive endoscopes include a biopsy channel, an objective lens, an LED light source, a water inlet channel and a water outlet channel, among which the biopsy channel is used for feeding into the clamping section and the traction section.
  • a traction device includes a clamping portion and a traction portion, the traction portion includes a closed traction structure, the closed traction structure is made of an elastic material, and the clamping portion includes a clamping body and a clamping arm, The clamping body can pass through the biopsy channel of the endoscope; the clamping arm can clamp the closed traction structure.
  • the closed traction structure is made of silicone rubber or a thermoplastic elastomer.
  • the closed traction structure may be circular, triangular, rhombic or square.
  • An elastic structure may be connected between two or more closed traction structures.
  • the elastic structure is an elastic linear structure, an elastic ring or the like.
  • Moving the clamping body can cause the closed traction structure to undergo elastic deformation.
  • a pull ring for a traction device is a closed traction structure or a plurality of closed traction structures connected.
  • the pull ring is made of an elastic material, and the elastic structures are connected between the closed traction structures. .
  • the elastic structure is an elastic linear structure, an elastic ring or the like.
  • the closed traction structure may be circular, triangular, diamond or square and the like.
  • the electric knife can be marked along the periphery of the lesion.
  • the electric knife or an external syringe is used to inject the liquid, so that the diseased tissue bulges, and a liquid buffer layer, ie, a "water pad", is formed under the mucosa.
  • a liquid buffer layer ie, a "water pad”
  • “Efficient isolation is formed between the muscular layer and the diseased tissue, and it also effectively prevents heat conduction, makes the surgical field clearer, the blood vessels are squeezed and closed by the water cushion, and the risk of bleeding is significantly reduced.
  • the electric knife is withdrawn, the first clamping portion of the traction device is opened, the clamping arm of the first clamping portion is clamped to one end of the closed traction structure, and the first clamping portion and the closed traction are
  • the structure is placed into the endoscopic biopsy channel together, and after reaching the distal end of the biopsy channel, under the observation of the endoscope's eyepiece, the clamp arm of the first clamping part is opened to clamp one end of the pre-separated tissue and the closed traction structure. The end.
  • the proximal end and the distal end of the clamping body of the first clamping portion are separated, so that the distal end and the closed traction structure of the clamping body of the first clamping portion remain in the body.
  • the proximal end and the distal end of the clamping body of the second clamping portion are separated, so that the distal end of the clamping body of the second clamping portion and the closed traction structure remain in the body. Due to the elasticity of the closed traction structure, during the surgical cutting process, the cut lesion is turned out due to the elastic force of the traction part. With the progress of the surgical cutting operation, the cut lesion is continuously pulled up and gradually separated from the muscular layer until it is completely Pull up to completely complete the separation of the lesion. This method allows the lesion to be lifted while it is being cut, which widens the surgical field of vision. Under endoscopic vision, blood vessels under the cutting target can be found to avoid bleeding, making the surgical operation more convenient. Safe and shorten the operation time.
  • the traction device of the present invention combines the clamping portion and the traction portion into one body.
  • the traction portion is elastic and can provide a force in the body by relying on its extension. Because it does not need to provide external force, it is not limited by the anatomical position and the size of the lumen of the digestive tract, and it is especially suitable for difficult positions in ESD surgery.
  • the elasticity of the material is good, and the pulling range can be adjusted according to demand to meet the needs of cutting lesions of different sizes, which broadens the field of vision of ESD surgery, improves the speed of ESD surgery, and saves operation time.
  • 1A is a cross-sectional view and a front view of a traction section having two annular closed traction structures
  • FIG. 1B is a schematic diagram of a traction structure with three annular closed traction structures
  • FIG. 1C is a schematic diagram of a traction part having four annular closed traction structures
  • Figure 1D is a sectional view and a front view of a triangular closed traction structure
  • FIG. 2 is a schematic diagram of cooperation between a clamping portion and a traction portion
  • Fig. 3 is a schematic view of feeding a clamping part and a traction part into an endoscopic biopsy channel
  • Figure 4 is a schematic diagram of the first clamping part and the annular closed traction structure clamping the lesion under the guidance of the endoscope;
  • Figure 5 is a schematic diagram of a second clamping part and a ring-shaped closed traction structure clamping the lesion under the guidance of an endoscope;
  • Fig. 6 is a schematic diagram showing the mutual separation of the lesions by the clamping portion and the annular closed traction structure
  • Fig. 7 is a schematic diagram of separating a lesion when the traction device is narrow in space
  • FIG. 8 is a schematic diagram showing the elastic linear structure connecting the annular closed traction structures.
  • 9A-9C are schematic diagrams of the traction device reducing the lesion wound when the lesion wound is large
  • the end near the operator is referred to as the proximal end, and the end remote from the operator is defined as the distal end.
  • FIG. 1A is a schematic diagram of a traction unit 1 including two cyclic closed traction structures. The two cyclic structures are closed and connected to form a traction unit 1 with a closed traction structure.
  • 1B and 1C are schematic diagrams of the traction section 1 as three annular closed traction structures and four annular closed traction structures.
  • Figure 1D is a cross-sectional view and a front view of a triangular closed traction structure. As shown in FIG. 8, the traction section 1 can also install an elastic linear structure in a closed traction structure.
  • the closed traction structure 11 may be made of an elastic material, preferably, the elastic material is a silicone rubber or a thermoplastic elastomer, and the closed traction structure may be one, two or more. In actual use, according to the size of the lesion, different types of traction parts can be selected for pulling and separation, which is suitable for mucosa, tissues, organs, etc.
  • FIG. 2 is a schematic diagram of the cooperation between the clamping portion 2 and the traction portion 1.
  • the clamping portion 2 includes clamping bodies 23 and 25 and clamping arms 24 and 26.
  • the electric knife is withdrawn, the clamping arm 24 of the traction device clamping portion 2 is opened, and the clamping arm 24 clamps one end of the closed traction structure 11 of the traction portion 1.
  • the first clamping portion 21 and the closed traction structure 11 are placed into the biopsy channel 4 of the endoscope 3. After reaching the distal end of the biopsy channel 4, under the eyepiece observation of the endoscope 3, The clamping arm 24 of the first clamping portion 21 is opened so that it simultaneously clamps one side of the pre-separated lesion 5 and one end of the closed traction structure 11.
  • the clamping main body 23 of the first clamping portion 21 is again The distal end and the proximal end are separated, so that the distal end of the first clamping portion 21 holding the main body and the closed traction structure 11 remain in the body, and the clamping main body 23 is taken out.
  • FIG. 5 after inserting the second clamping portion 22 into the endoscopic biopsy channel 4 to reach the distal end of the biopsy channel 4, under the eyepiece observation of the endoscope 3, 26 clamping arms of the second clamping portion 22 are opened. Open, clamp the other end of the closed traction structure 11 and pull it to the other side of the pre-separated lesion 5 with the help of an endoscope.
  • the proximal end and the distal end of the clamping body 25 of the second clamping portion 22 are separated, so that the distal end of the clamping body of the second clamping portion 22 and the closed traction structure 11 remain in the body. Due to the elasticity of the closed traction structure 11, during the surgical cutting process, the cut lesion 5 is turned out due to the elastic force of the traction part 1. With the progress of the surgical cutting operation, the cut lesion 5 is continuously pulled up, and the muscular layer 7 Gradually separate until it is completely pulled up, and complete the separation of the lesion 5. This method allows the lesion 5 to be lifted while being cut, which widens the surgical field of vision. Under endoscopic vision, blood vessels under the mucosa can be found to avoid bleeding.
  • the clamping portion 2 and the closed traction structure can be added so that the cut lesion 5 is completely pulled up, or the traction portion 1 containing an elastic linear structure is selected as shown in FIG. 8 so that the entire traction portion 1
  • the range of elastic deformation is increased to stretch a larger area of the lesion 5.
  • one side of the lesion 5 can be cut open, as shown in Figure 4, first through the first clamping part
  • the clamping arm 24 of 21 clamps the incision lesion 5.
  • it is fed into the second clamping part 22 through the endoscope 3, and the clamping arm of the second clamping part 22 is observed through the eyepiece of the endoscope 3.
  • 26 is clamped to the mucosal layer 8 on the opposite side of the intestinal lumen, and the clamping arm 26 of the second clamping portion 22 is closed tightly.
  • the cut lesion 5 is under the elastic force of the closed traction structure 11 as the surgical cutting operation proceeds Being continuously pulled up to maintain the surgical field of vision and facilitate surgical operations.

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Abstract

一种牵引装置，包括夹持部（2）和牵引部（1），牵引部含有封闭牵引结构（11），封闭牵引结构由弹性材料制成，夹持部包括夹持主体（23，25）和夹臂（24，26），夹持主体能够穿过内镜（3）的活检通道（4），夹臂可以夹住封闭牵引结构。还公开了一种用于牵引装置的牵拉环，牵拉环为一个封闭牵引结构或若干个封闭牵引结构连接而成，牵拉环由弹性材料制成。

Description

一种牵引装置以及用于牵引装置的牵拉环 技术领域
本发明涉及一种医疗器械领域的一种牵引装置以及用于牵引装置的牵拉环，特别是涉及一种弹性好，不需要外力，仅依靠牵引部的弹力就能实现对切割病灶的牵引，充分暴露手术操作视野；同时可以牵拉缩小大的创面，从而方便创面进一步夹闭的牵引装置。
技术背景
EMR(endoscopic mucosal resection，EMR)治疗早期胃癌最早在日本用于临床，在其引入日本之前，胃切除术是早期胃癌唯一的治疗方法，目前该治疗方法已广泛在应用。内镜下黏膜剥离术(endoscopic submucosal dissection，ESD)是指在内镜下运用改良的针刀直接从黏膜下层对黏膜进行剥离，由黏膜切除术EMR演进而来，因其完整切除率高，安全性好，使消化道早癌及其它肿瘤切除的适应症扩大，逐步成为广为接受的微创外科治疗方式。
ESD和EMR都实现了用一根普通单通道内镜对病变进行切除，并免除了开腹手术的痛苦和器官的切除。EMR的缺点在于该技术不能整块切除较大块的病变，取出的碎块状标本难以进行详细的病理分析，肿瘤分期不明确，存在较高的肿瘤复发风险。而ESD与剖腹手术及以往EMR等内镜治疗方法比较，具有1、创伤小，2、患者可接受多个部位多次治疗，3、使医生获得完整的组织病理标本以供分析，4、对于面积较大且形态不规则或合并溃疡、瘢痕的肿瘤进行96％以上的切除率，以减小复发概率。
但ESD较EMR操作时间长、风险大、操作难。EMR的手术时间约20分钟左右，而大部分ESD的操作时间在60-90min，存在诸如着出血、穿孔、狭窄和术后感染等并发症，不利于大规模的推广和应用。EMR术中很少出血，但在ESD操作过程中，稍不留意，视野就会被血液覆盖，要不断地止血和冲洗视野。ESD手术的主要步骤为：标记、黏膜下注射、边缘切开、剥离，以及创面处理。对一些ESD治疗困难部位的病灶，通常采取反复的黏膜下注射为后续剥离操作提供有限的手术视野，但反复注射可使手术时间延长，增加出血、穿孔的危险。另一种简单的方案是可根据重力的方向尝试调整病人体位，使剥离面获得理想的张力，获得操作视野，但在某些手术(涉及上消化道)中，病人可选择体位有限，限制了其使用效果。因此如何在术中提供良好"手术视野"成为解决上述问题的关键，各国学者努力寻求能为手术提供良好视野，实现安全、精确切割和剥离操作的方法。
受外科牵拉技术启发，各种内镜辅助牵引技术应运而生。按牵引力来源的部位可大致分为体内牵引和体外牵引；按牵引装置构成又可分为牙线牵引，金属夹丝线联合牵引技术、金属夹弹力圈联合牵引技术、S-O金属夹牵引技术、磁力锚技术等。
近期消化内镜有文章在讨论部分指出，虽然牙线是比较好的辅助ESD，但会有组织损伤的可能，需要在使用时注意这一点，另外牙线牵引固定了方向，牵引端在体外，所以牙线必须要与内镜平行的方向，导致牵引方向受限。
金属夹丝线联合牵引技术，丝线没有弹性，在切割一部分病灶后，丝线可能会失去效果，无法继续牵拉病灶，切割过程不能顺利进行。
金属夹弹力圈联合牵引技术，弹力圈大小有限制，需要用丝线将O型圈捆扎于夹子上，另外还要使用专用外鞘，操作繁琐，给使用者带来不便。
S-O金属夹牵引技术，以弹簧、金属夹和尼龙圈为基础设计出一种体内牵引技术。该方法由金属夹弹力圈联合牵引法衍变而来，以弹簧替代弹力圈，力求获得更大的伸缩性，来适应对大的、表浅性的结肠早期肿瘤的ESD切除，但是切割后弹簧没有张力，且弹簧占据空间体积大，不能进入内窥镜活检通道，而需要在手术时取出内镜，在体外用伸出内窥镜活检通道的金属夹夹住后，再送入体内，到达目标位置过程中，由于裸露在活检通道远端，容易对人体造成伤害，该方法使用受限。
磁力锚牵引技术，需要专用的设备，比如配备制式可伸缩臂，在体外不断改变方向牵引，操作繁琐，且在手术过程中，若磁铁数量较多，会妨碍操作的视野。
发明内容
本发明的牵引装置由夹持部和牵引部组成，牵引部依靠自身的弹力，发生弹性形变延伸即可在体内提供牵引作用力牵拉病灶，充分暴露手术操作视野。由于不需提供外力，可不受解剖位置和消化道管腔大小的限制，可以对黏膜、组织、器官进行牵引，特别适用于ESD手术操作困难位置，使得医生可以在更加直观、可视的情况下实施黏膜剥离手术，手术可以更加安全、简便，可以大大缩短手术用时、减少病人痛苦，适用于大面积的病灶剥离。
常用消化内镜包括活检通道，物镜，LED光源，进水通道和出水通道等，其中活检通道用于送入夹持部和牵引部。
一种牵引装置，所述牵引装置包括夹持部和牵引部，所述牵引部含有封闭牵引结构，所述封闭牵引结构由弹性材料制成；所述夹持部包括夹持主体和夹臂，所述夹持主体能够穿过内镜的活检通道；所述夹臂可以夹住所述封闭牵引结构。
优选地，封闭牵引结构由硅橡胶或热塑性弹性体制成。
优选地，封闭牵引结构为一个，两个或者多个。
优选地，封闭牵引结构可以为圆形，三角形，菱形或方形等。
可以在两个或多个封闭牵引结构之间连接弹性结构，优选地，弹性结构为弹性线状结构，弹力圈等结构。
移动夹持主体，可以使得封闭牵引结构发生弹性形变。
一种用于牵引装置的牵拉环，所述牵拉环为一个封闭牵引结构或若干个封闭牵引结构连接而成，所述牵拉环由弹性材料制成，封闭牵引结构之间连接弹性结构。
优选地，弹性结构为弹性线状结构，弹力圈等结构。
优选地，封闭牵引结构可以为圆形，三角形，菱形或方形等等。
在实际操作过程中，可以将电刀在病变位置沿周圈进行标记，通过电刀或者外接注射器注液，使得病变组织隆起，并在黏膜下形成液体缓冲层即“水垫”，“水垫”在肌层和病变组织间形成有效隔离，同时也有效阻止了热传导，使手术视野更清晰，血管受到水垫的挤压封闭，出血的风险显著降低。在体内完成预分离黏膜后，将电刀退出，将牵引装置的第一夹持部打开，将第一夹持部的夹臂夹住封闭牵引结构的一端，将第一夹持部和封闭牵引结构一起置入内镜的活检通道，到达活检通道的远端后，通过内镜的目镜观察下，将第一夹持部的夹臂张开，夹住预分离的组织的一端和封闭牵引结构的一端。此时再将第一夹持部的夹持主体近端和远端分离，使得第一夹持部的夹持主体的远端和封闭牵引结构留在体内。继续重复前序操作，将第二夹持部置入内镜的活检通道，到达活检通道的远端后，通过内镜的目镜观察下，将第二夹持部的夹臂张开，穿过封闭牵引结构的另一端，在内镜的帮助下，牵拉到预分离的组织的另一端并夹闭预分离组织的边缘。再将第二夹持部的夹持主体的近端和远端分离，使得第二夹持部的夹持主体远端和封闭牵引结构留在体内。由于封闭牵引结构具有弹力，手术切割过程中，被切割的病灶因牵引部弹力作用外翻，随着手术切割操作的进行，被切割的病灶被不断牵拉起来，和肌层逐渐分离，直至完全拉起，彻底完成病灶的分离，这种方式使得病灶一边被切割一边被翻起，开阔了手术视野，在内镜直视下可以发现切割目标下的血管，避免出血，使得手术操作更加方便、安全，缩短手术时间。如果病灶过大，可以增加夹持部和封闭牵引结构，使得被切割的病灶完全牵拉起来，或者选择含有弹性线状结构的牵引部，使得整个牵引部的弹性形变范围增加，以牵拉较大面积的病灶。
有益效果：
本发明的牵引装置，将夹持部和牵引部联合为一体，牵引部具有弹性，可依靠自身的延伸即可在体内提供作用力。由于不需提供外力，可不受解剖位置和消化道管腔大小的限制，特别适用于ESD手术操作困难位置。材料的弹性好，可根据需求调节牵拉范围大小，满足不同大小的病灶切割的需求，开阔了ESD手术的视野，提高了ESD手术的速度，节省了手术 时间。
在该产品在实际使用过程中，如果发现有牵引松动情况，可以再增加若干个夹持部，夹住封闭牵引结构，向其它的方向牵拉，然后夹闭，形成多边形结构，可以继续提供牵拉力，开阔了操作视野，直至组织完全分离，使得分离过程顺利进行。
附图说明
图1A是牵引部为两个环状封闭牵引结构的剖视图和主视图
图1B是牵引部为三个环状封闭牵引结构的示意图
图1C是牵引部为四个环状封闭牵引结构的示意图
图1D是三角形封闭牵引结构的剖视图和主视图
图2是夹持部和牵引部相互配合示意图
图3是将夹持部和牵引部送入内镜活检通道示意图
图4是内镜引导下第一夹持部和环状封闭牵引结构夹住病灶示意图
图5是内镜引导下第二夹持部和环状封闭牵引结构夹住病灶示意图
图6是夹持部和环状封闭牵引结构相互配合分离病灶示意图
图7是牵引装置在空间较狭窄时分离病灶示意图
图8是环状封闭牵引结构间连接弹性线状结构示意图
图9A-9C是病灶创面较大时牵引装置缩小病灶创面示意图
1、牵引部，11、封闭牵引结构，2、夹持部，21、第一夹持部，22、第二夹持部，23、夹持主体，24、夹臂，25、夹持主体，26、夹臂，3、内镜，4、活检通道，5、病灶，6、黏膜层，7、肌层，8、管腔对侧黏膜层
具体实施方式
为了使本发明的目的、技术方案及优点更加清楚明白，以下结合附图及实施例，对本发明进行进一步详细说明。应当理解，此处所描述的具体实施例仅用以解释本发明，并不用于限定本发明。
以下，将内镜靠近操作者的一端为近端，将远离操作者的一端定义为远端。
如图1A-1D以及图8是不同类型的封闭牵引结构示意图。图1A是牵引部1含有两个环状封闭牵引结构的示意图，两个环状结构封闭连接构成封闭牵引结构的牵引部1。图1B和1C是牵引部1为三个环状封闭牵引结构和四个环状封闭牵引结构的示意图。图1D是三角形 封闭牵引结构的剖视图和主视图。如图8所示，牵引部1也可以在封闭牵引结构内安装弹性线状结构，封闭牵引结构和弹性线状结构均能产生弹性形变，使得病灶5完全与黏膜层6分离，这种结构尤其适合病灶5比较大的情况。封闭牵引结构11可以由弹性材料制成，优选地，该弹性材料是硅橡胶或热塑性弹性体，封闭牵引结构可以为一个，两个或者多个。实际使用过程中，可以根据病灶尺寸的不同，选择不同类型牵引部进行牵拉分离，适用于黏膜、组织、器官等。
以下，以牵引部仅有封闭牵引结构组成的情况为例，说明本发明中牵引装置用于黏膜牵引分离的使用过程。实际操作过程中，可以将电刀通过内镜活检通道插入病变组织附近，在病变位置周围进行标记，标记完成后，通过电刀或者外接注射器注液，使得病变组织隆起，并在黏膜下形成液体缓冲层即“水垫”。如图2-6所示，图2为夹持部2和牵引部1相互配合示意图，夹持部2包括夹持主体23和25以及夹臂24和26。在体内完成预分离黏膜后，将电刀退出，打开牵引装置夹持部2的夹臂24，将夹臂24夹住牵引部1的封闭牵引结构11的一端。如图3和图4所示，将第一夹持部21和封闭牵引结构11一起置入内镜3的活检通道4，到达活检通道4的远端后，在内镜3的目镜观察下，将第一夹持部21的夹臂24张开，使其同时夹住预分离的病灶5的一侧和封闭牵引结构11的一端，此时再将第一夹持部21的夹持主体23远端和近端分离，使得第一夹持部21夹持主体的远端和封闭牵引结构11留在体内，取出夹持主体23。如图5所示，将第二夹持部22插入内镜活检通道4内到达活检通道4的远端后，在内镜3的目镜观察下，将第二夹持部22的夹臂26张开，夹住封闭牵引结构11的另一端，在内镜的帮助下，牵拉到预分离的病灶5的另一侧。再将第二夹持部22的夹持主体25近端和远端分离，使得第二夹持部22的夹持主体的远端和封闭牵引结构11留在体内。由于封闭牵引结构11具有弹力，手术切割过程中，被切割的病灶5因牵引部1弹力作用外翻，随着手术切割操作的进行，被切割的病灶5被不断牵拉起来，和肌层7逐渐分离，直至完全拉起，彻底完成病灶5的分离，这种方式使得病灶5一边被切割一边被翻起，开阔了手术视野，在内镜直视下可以发现黏膜下的血管，避免出血，使得手术操作更加方便、安全，缩短手术时间。如果病灶5过大，可以增加夹持部2和封闭牵引结构，使得被切割的病灶5完全牵拉起来，或者如图8所示选择含有弹性线状结构的牵引部1，使得整个牵引部1的弹性形变范围增加，以牵拉较大面积的病灶5。
如图4和图7所示，当病灶5比较大，而空间比较小时，如在肠道内ESD手术时，可以先将病灶5的一侧切开，如图4，先通过第一夹持部21的夹臂24将切开的病灶5夹住，此时，再通过内镜3送入第二夹持部22，通过内镜3的目镜观察下，将第二夹持部22的夹臂26夹到肠道管腔对侧黏膜层8上，将第二夹持部22的夹臂26闭紧，被切割的病灶5在封闭 牵引结构11的弹力作用下，随着手术切割操作的进行被不断牵拉起来，保持手术视野，方便手术操作。
如图9A-9C所示，当病灶5的创面比较大时，在内镜3的帮助下，先用第一夹持部的夹臂24将病灶5的创面的一侧和封闭牵引结构11的一端夹住，然后在内镜3的帮助下，再用第二夹持部的夹臂26将病灶5的创面的另一侧和封闭牵引结构11另一端夹住，由于封闭牵引结构11的弹力将病灶5的创面两侧向内拉，使得病灶5的创面缩小，从而方便病灶5的创面进一步夹闭。
上所述仅是本申请的优选实施方式，使本领域技术人员能够理解或实现本申请的发明。对于这些实施例的多种修改及组合对于本领域的技术人员来说将是显而易见的，本文中所定义的一般原理可以在不脱离本申请的精神或范围的情况下，在其他实施例中实现。因此，本申请将不会被限制在本文所示的这些实施例，而是要符合与本文所公开的原理和新颖特点相一致的最宽的范围。

Claims (13)

  1. 一种牵引装置，其特征在于，所述牵引装置包括夹持部和牵引部，所述牵引部含有封闭牵引结构，所述封闭牵引结构由弹性材料制成；所述夹持部包括夹持主体和夹臂，所述夹持主体能够穿过内镜的活检通道；所述夹臂可以夹住所述封闭牵引结构。
  2. 根据权利要求1所述的牵引装置，其特征在于，所述封闭牵引结构由硅橡胶或热塑性弹性体制成。
  3. 根据权利要求1所述的牵引装置，其特征在于，所述封闭牵引结构为一个，两个或者多个。
  4. 根据权利要求3所述的牵引装置，其特征在于，可以在两个或多个封闭牵引结构之间连接弹性结构。
  5. 根据权利要求4所述的牵引装置，其特征在于，所述弹性结构为弹性线状结构。
  6. 根据权利要求4所述的牵引装置，其特征在于，所述弹性结构为弹力圈。
  7. 根据权利要求1-6其中任意一项所述的牵引装置，其特征在于，所述封闭牵引结构为圆形，三角形，菱形，方形。
  8. 根据权利要求1所述的牵引装置，其特征在于，移动夹持部的夹持主体，可以使得封闭牵引结构发生弹性形变。
  9. 一种用于牵引装置的牵拉环，其特征在于，所述牵拉环为一个封闭牵引结构或若干个封闭牵引结构连接而成，所述牵拉环由弹性材料制成。
  10. 根据权利要求9所述的牵拉环，其特征在于，所述封闭牵引结构之间连接弹性结构。
  11. 根据权利要求10所述的牵拉环，其特征在于，所述弹性结构为弹性线状结构。
  12. 根据权利要求10所述的牵拉环，其特征在于，所述弹性结构为弹力圈。
  13. 根据权利要求9所述的牵拉环，其特征在于，所述封闭牵引结构为圆形，三角形，菱形，方形。
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JP3232938U (ja) 2021-07-15
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CN110731802A (zh) 2020-01-31
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