WO2020151145A1 - 用于内镜下经肛门结肠向小肠植入的管道器械及植入方法 - Google Patents

用于内镜下经肛门结肠向小肠植入的管道器械及植入方法 Download PDF

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WO2020151145A1
WO2020151145A1 PCT/CN2019/088519 CN2019088519W WO2020151145A1 WO 2020151145 A1 WO2020151145 A1 WO 2020151145A1 CN 2019088519 W CN2019088519 W CN 2019088519W WO 2020151145 A1 WO2020151145 A1 WO 2020151145A1
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small intestine
endoscope
tube
guide wire
anus
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PCT/CN2019/088519
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English (en)
French (fr)
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张发明
崔伯塔
温泉
赵文俊
徐传友
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南京法迈特科技发展有限公司
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Priority claimed from CN201910065816.5A external-priority patent/CN109620313B/zh
Priority claimed from CN201920125659.8U external-priority patent/CN209713006U/zh
Application filed by 南京法迈特科技发展有限公司 filed Critical 南京法迈特科技发展有限公司
Publication of WO2020151145A1 publication Critical patent/WO2020151145A1/zh

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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M31/00—Devices for introducing or retaining media, e.g. remedies, in cavities of the body

Definitions

  • the invention relates to a pipeline device and an implantation method in the field of medical devices, in particular to a pipeline device and an implantation method used for endoscopic implantation into the small intestine through the anus and colon.
  • the digestive tract of the human body is called the upper digestive tract from the oral cavity to the duodenal papilla, and the digestive tract from the ileocecal valve to the anus is called the lower digestive tract according to the dividing line of the organ markers visible under the endoscope.
  • the digestive tract from the duodenal papilla to the ileocecal valve is called the middle digestive tract.
  • TET Transendoscopic entral tubing
  • the end of the small intestine is an important site for immunological diseases such as Crohn's disease. This also proves that the end of the small intestine will be an important advancement in the route of administration as an important site for local administration.
  • endoscopy technology is highly developed, combined with our research on TET technology in the past few years, we have made breakthroughs in technology that is only used for colon implantation and drug delivery.
  • the technical difficulty of implanting a tube into the small intestine and keeping it for drug delivery is very important.
  • the first objective of the present invention is to provide a method for safely implanting one end of a soft tube into the small intestine under an endoscope, and fixing it to the soft and tortuous wall of the small intestine easily and safely.
  • the second object of the present invention is to provide a method for implanting the tube device used for endoscopic implantation into the small intestine through the anus and colon.
  • the present invention discloses a pipe instrument for endoscopic implantation into the small intestine through the anus and colon, which includes a flexible hollow pipe with a proximal end and a distal end and a distance fixed on the hollow pipe Multiple single-ring fixed wire loops larger than 3cm, the hollow tube is provided with an elastic guide wire that can move freely in the axial direction from the proximal end, and the guide wire does not pass through the distal end of the hollow tube and A guide wire-free catheter section is formed at the distal end of the hollow pipe; the guide wire is also connected with a non-metal homogeneous booster for pushing the pipe.
  • the length L of the guidewire-free catheter section is 3-10 cm.
  • the design of the guidewire-free catheter section of the present invention facilitates the use of auxiliary instruments to clamp the distal end of the hollow pipe or the single-loop fixing wire loop at the distal end from the ileocecal part through the ileocecal valve and enters the end of the small intestine, which increases the chance of successful operation. Reduce surgery time.
  • the end of the non-metal homogenous booster connected with the guide wire is provided with a boss that is convenient for pushing the pipe, and the diameter of the boss is greater than or equal to the diameter of the hollow pipe.
  • non-metal homogeneous booster and the guide wire are connected by a detachable card slot.
  • the diameter of the hollow pipe is ⁇ 2.5mm.
  • the fold length of the loops of the single-loop fixed wire loop is 1 to 2.5 cm, and the distance L1 between adjacent single-loop fixed wire loops is greater than 3 cm.
  • the single-loop fixing wire loop of the present invention satisfies the clamping operation of the loop wire with the arm length 1cm fixing titanium clip under the endoscope, avoids the premature fall of the fixed wire due to improper force due to the excessively long wire loop, and avoids the short wire loop As a result, the titanium clip cannot be clamped; at the same time, the single-ring design also avoids the thread knot that may cause the intestinal cavity content to solidify and agglomerate.
  • the distance between the single-loop fixing wire loops satisfies the gap between the annular folds of the intestine to reduce the mutual pulling of the two single-loop fixing wire loops during the peristalsis and extension process, and avoiding the single-loop fixing ring prematurely caused by mutual pulling The problem of shedding from the intestinal wall.
  • the hollow pipe is provided with a plurality of holes communicating with the inside of the pipe, and the distance between the end of the guide wire near the distal end of the hollow pipe and the adjacent hole is L2 ⁇ 2cm.
  • the guide wire design of the present invention completely avoids that the guide wire will not pass through the adjacent holes during the operation process and cause iatrogenic injury.
  • the present invention is an implantation method based on a tube device used for endoscopic implantation into the small intestine through the anus and colon, which includes the following steps:
  • the endoscope needs to be sent to the target location of the small intestine through the anus-colon;
  • the endoscope is slowly pushed out of the anus, and then the guide wire is pulled out, and the connecting cap that can be inserted into the proximal end of the hollow tube is used to facilitate the docking of the infusion device.
  • the pipeline device of the present invention utilizes the combined structure design of the guide wire, the hollow tube and the non-metal homogenous booster to facilitate the safe implantation of the soft tube tip into the small intestine under the endoscope, and the convenient and safe fixation To the soft and tortuous intestinal wall of the small intestine, it is necessary to break through the device design that the tube was only used for colon implantation;
  • the single-loop fixing wire loop of the present invention satisfies the clamping operation of the loop wire with a titanium clip for fixing with an arm length of 1 cm under the endoscope, avoiding the premature fall of the fixing wire due to improper force due to the excessively long wire loop, and avoiding the wire If the ring is too short, the titanium clip cannot be clamped; at the same time, the single-ring design also avoids that the knots may cause the intestinal cavity content to solidify and agglomerate; the distance between the single-ring fixed wire loops in the present invention satisfies the peristaltic and peristaltic spacing of the intestinal folds. During the extension process, the mutual pulling of the two single-loop fixing loops is reduced to avoid the problem of the single-loop fixing ring falling off the intestinal wall prematurely due to mutual pulling;
  • the design of the guidewire-free catheter section of the present invention facilitates the use of auxiliary instruments to clamp the distal end of the hollow tube or the single-loop fixation wire loop at the distal end from the ileocecal area through the ileocecal valve and enters the end of the small intestine, increasing the operation Success rate, reducing the time spent on surgery;
  • the present invention greatly saves equipment processing cost, and makes the price of equipment more suitable for public medical payment.
  • Figure 1 is a schematic diagram of the structure of the present invention.
  • the present invention is a pipeline device used for endoscopic implantation into the small intestine through the anus and colon, which includes a hollow tube 3, a single-loop fixing wire loop 4, a guide wire 5 and a non-metal homogeneous booster 6 .
  • the hollow tube 3 of the present invention is a bendable elastic member.
  • the hollow tube has a proximal end 1 and a distal end 2.
  • the hollow tube at the distal end is also called the oral end, and vice versa, the proximal end in the direction of the anus is also called Anal end.
  • the diameter of the hollow pipe 3 is greater than or equal to 2.5 mm, and the hollow pipe 3 is provided with a plurality of holes 8 communicating with the inside of the pipe.
  • the distance between the end of the guide wire 5 near the distal end of the hollow pipe and the adjacent holes 8 is L2 greater than or equal to 2 cm.
  • the diameter of the guide wire of the present invention is much smaller than the inner diameter of the hollow pipe, and the spatial position of the guide wire in the pipe will undergo uncontrollable changes due to the bending radian, the number of bends, and the shrinkage caused by resistance, that is to say, the actual operation During the process, if the hollow tube is straightened, the guide wire inside will also maintain a straight state, and the distance between the tip end of the guide wire and the distal end of the hollow tube will be obtained, but if there are different degrees of bending, this distance will become different. stable.
  • hollow pipes of different materials may be shortened or extended after being processed and formed due to factors such as placement time and temperature.
  • the guide wire may be too long in the hollow pipe during use. Even longer than the hollow tube, it may cause puncture and perforation of the intestinal wall; in addition, if it just penetrates through the hole, the possibility of causing iatrogenic injury is very high.
  • the guide wire design of the present invention can completely avoid that the guide wire will not pass through the adjacent holes during the operation process and cause iatrogenic injury.
  • single-ring fixed wire loops 4 of the present invention are fixed on the hollow pipe 3 at intervals, and the longitudinal distance between adjacent single-loop fixed wire loops 4 is greater than 3 cm.
  • the length of the wire loops of the single-loop fixed wire loop 4 is 1 to 2.5 cm, and the distance L1 between adjacent single-loop fixed wire loops 4 is greater than 3 cm.
  • the single-loop fixing wire loop of the present invention satisfies the clamping operation of the loop wire with the arm length 1cm fixing titanium clip under the endoscope, avoids the premature fall of the fixed wire due to improper force due to the excessively long wire loop, and avoids the short wire loop As a result, the titanium clip cannot be clamped; at the same time, the single-loop design also avoids that the knots may cause the intestinal cavity content to solidify and agglomerate; in the present invention, the distance between the single-loop fixed wire loops satisfies the distance between the intestinal folds during peristalsis and extension. Reduce the mutual pulling of the two single-loop fixing wire loops, and avoid the problem of the single-loop fixing ring falling off the intestinal wall prematurely due to mutual pulling.
  • the guide wire 5 of the present invention is a flexible and homogeneous guide wire, and the guide wire 5 can move freely along the axial direction of the hollow pipe 3.
  • the guide wire 5 penetrates into the hollow tube 3 from the proximal end 1 of the hollow tube 3 without passing through the distal end of the hollow tube 3, and forms a guidewire-free catheter section at the proximal end 1 of the hollow tube 3.
  • the length L of the guidewire-free catheter section is 3-10 cm. In actual operation, when the endoscope reaches the target position, the tube is often not in place. If the tube has returned to the colon due to the pulling of the endoscope, tools such as foreign body forceps or disposable titanium clamps must be used.
  • the endoscope clamps the distal end of the hollow tube or the fixing wire loop of the distal end of the hollow tube under direct vision, and uses the opportunity of the endoscope to move to the small intestine to hold the hollow tube into the target position of the small intestine. From the large intestine to the small intestine, the biggest technical pass is through the ileocecal valve. The diameter of the valve is smaller than the intestinal cavity, and the angle at this point is large. When the endoscope carries the hollow tube through this point and enters the twisted intestinal cavity of the small intestine, it is very Prone to failure or take a long time. For patients under anesthesia, prolonging the operation time will increase the risk of anesthesia and increase the medical expenses of drugs and monitoring.
  • the design of the guidewire-free catheter section of the present invention is convenient for clamping the distal end of the hollow tube or the single-loop fixing wire loop at the distal end of the hollow tube with the auxiliary instrument under the endoscope. , To reduce the time spent on surgery.
  • the guide wire 5 is also connected with a non-metal homogenous booster 6 for pushing the pipeline.
  • the non-metal homogenous booster 6 and the guide wire 5 are connected by a detachable card slot, or a non-metal homogenous booster 6 is wrapped around the guide wire 5 to form an integral connection.
  • the end of the non-metal homogenous booster 6 connected to the guide wire 5 is provided with a boss 7 that is convenient for pushing the pipe, and the diameter of the boss 7 is greater than or equal to the diameter of the hollow pipe 3.
  • the guide wire 5 of the present invention generally chooses a metal material with a smooth surface.
  • the non-metal homogeneous booster 6 only needs to be used to push the hollow tube and its guide wire smoothly through the endoscope clamp channel hole and leave the endoscope, its diameter needs to be smaller than the endoscope clamp channel hole, usually less than 2.7mm , Or less than 3.2mm.
  • the surface of the non-metal homogeneous booster 6 is smooth, and it is preferable to use a plastic or polymer material without metal.
  • the design of the homogeneous metal guide wire 5 and the non-metal homogeneous booster 6 of the present invention greatly reduces the medical cost.
  • the fixation of the present invention generally selects a disposable endoscope clip (such as a titanium clip) to be fixed in the intestinal cavity under an endoscope.
  • a disposable endoscope clip such as a titanium clip
  • it can also be implanted through the anus-colon route, using laparoscopic suture technology, with the aid of enteroendoscope for transmural fixation thread loop , In order to achieve a stable fixed soft catheter, which is very important for long-term indwelling the catheter in the small intestine.
  • the present invention is used for implanting and fixing a tube into the small intestine through the anus-colon, but is not limited to using the target location for the end of the small intestine, and can also be used for fixing the ileocecal, ascending colon, transverse colon and descending colon.
  • the present invention is an implantation method based on a tube device used for endoscopic implantation into the small intestine through the anus and colon, which includes the following steps:
  • the endoscope needs to be sent to the target location of the small intestine through the anus-colon;
  • the endoscope is slowly pushed out of the anus, and then the guide wire is pulled out, and the connecting cap that can be inserted into the proximal end of the hollow tube is used to facilitate the docking of the infusion device.
  • the length of the hollow pipe 3 of the present invention is 130cm, the opening at the mouth side end is smooth, the single-loop fixing wire loop 4 has a length of 1 cm folded in half, 1.5cm from the mouth side end, there is a channel 8, 3 cm from the mouth side end, 1 cm away Fold in half length is 1cm single loop fixed wire loop.
  • the material used for the fixing thread loop is medical surgical nylon thread, which does not adhere to the intestinal juice and intestinal wall. Although the titanium clip used for fixation has sharp edges, it does not pose a risk of breaking the thread loop due to the cutting.
  • the length of the homogeneous metal guide wire 5 is 126cm, and the end of the guide wire near the anal side is connected to the non-metal homogeneous booster 6.
  • the non-metal homogeneous booster 6 is a plastic guide wire with a diameter of 2mm, which is longer than conventional colonoscopy
  • the length is 8cm, which is preferably 180cm.
  • the present invention is an implantation method based on a tube device used for endoscopic implantation into the small intestine through the anus and colon, which includes the following steps:
  • the endoscope needs to be sent to the target position of the small intestine, which is 10cm away from the ileocecal valve;
  • the selected guide wire length, material, and non-metal homogeneous booster 6 materials of the present invention can save processing cost by 60%.
  • the length of the hollow pipe 3 of the present invention is 140 cm, the opening at the mouth side end is smooth, the single-ring fixed wire loop 4 has a length of 1 cm folded in half, and there is a channel 8 at a distance of 1.5 cm from the mouth side end, and 3 cm, 10 cm, and 20 cm from the mouth side end.
  • the fixing wire loop away from the side end of the mouth is suitable for fixing the ileocephalic area.
  • the material used for the fixing thread loop is medical surgical nylon thread, which does not adhere to the intestinal juice and intestinal wall. Although the titanium clip used for fixation has sharp edges, it does not pose a risk of breaking the thread loop due to the cutting.
  • the length of the homogenous metal guide wire is 135cm, and the end of the guide wire near the anal side is connected to the non-metal homogenous booster 6.
  • the non-metal homogenous booster 6 is a plastic guide wire with a diameter of 2 mm, which is longer than the length of a conventional enteroscopy. 8cm, which is preferably 210cm.
  • the invention is mainly used for implantation of the small intestine into the deep part of the small intestine through auxiliary, and used for drug delivery in the deep part of the small intestine and colon.
  • the present invention is an implantation method based on a tube device used for endoscopic implantation into the small intestine through the anus and colon, which includes the following steps:
  • the endoscope needs to be sent to the target position of the small intestine, which is 40 cm away from the ileocecal valve;

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Abstract

一种用于内镜下经肛门结肠向小肠植入的管道器械，包括具有近端（1）和远端（2）的可弯曲弹性中空管道（3）和固定于中空管道（3）上间距大于3cm的多个单环固定线环（4），中空管道（3）从近端（1）处穿设有可沿轴向自由活动且可弯曲的弹性导丝（5），该导丝（5）不穿出中空管道（3）的远端（2），并在中空管道（3）的远端（2）处形成无导丝导管段；导丝（5）上还连接有用于推送管道的非金属均质助推件（6）。该管道器械的导丝（5）、中空管道（3）和非金属均质助推件（6）的组合结构便于内镜下将柔软的管道先端向小肠内安全的植入，并将其便捷、安全的固定到小肠柔软曲折的肠壁上。

Description

用于内镜下经肛门结肠向小肠植入的管道器械及植入方法 技术领域
本发明涉及一种医疗器械领域的管道器械及植入方法，尤其涉及一种用于内镜下经肛门结肠向小肠植入的管道器械及植入方法。
背景技术
人体的消化道，依据内镜下可见器官标志位分界线，将从口腔到十二指肠乳头的消化道称为上消化道，将回盲瓣至肛门的消化道称为下消化道，位于十二指肠乳头至回盲瓣的消化道称为中消化道。在2015年以前，全世界传统的医疗技术，无法实现从肛门向全结肠内进行无创伤的长时间重复给药。2015年，一种向结肠深部植入管道，用于全结肠(也被称为下消化道)途径粪菌移植，或全结肠广泛范围给药的技术已经用于临床，这就是我们发明并命名的经内镜肠道植管术(transendoscopic entral tubing，TET)。2016年，该技术的临床研究结果在学术杂志发表。在广泛推广和进一步研究该技术过程中，我们发现在肠道不仅弯曲，而且弯曲还特别多的条件下，将一根软管放置到结肠的任意部位，本就不容易，离不开特定的操作技术和相应的特殊器械。如果要满足将其顺利、安全的送至小肠，并且将其固定在小肠内壁，用于长期留置和反复给药，在此之前，还没有器械和技术能够满足。然而，到目前为止，还没有技术可以实现从肛门小肠内留置管道用于重复给药。小肠末段是克罗恩病等免疫性疾病的重要发病部位，这也证明，将小肠末段作为局部给药的重要部位，将是给药途径的重要进步。在内镜技术高度发达的今天，结合我们在前几年针对TET技术的研究，突破只用于全结肠植管和给药的技术，用全新的器械设计和操作技术，解决经肛门-结肠途径向小肠植入管道并留置用于给药的技术困难非常重要。
发明内容
发明目的：本发明的第一目的是提供一种便于内镜下将柔软的管道一端向小肠内安全的植入，并将其便捷、安全的固定到小肠柔软曲折的肠壁上的用于内镜下经肛门结肠向小肠植入的管道器械。
本发明的第二目的是提供该用于内镜下经肛门结肠向小肠植入的管道器械的植入方法。
技术方案：为实现以上目的，本发明公开了一种用于内镜下经肛门结肠向小肠植入 的管道器械，包括具有近端和远端的可弯曲弹性中空管道和固定于中空管道上间距大于3cm的多个单环固定线环，所述中空管道从近端处穿设有可沿轴向自由活动且可弯曲的弹性导丝，该导丝不穿出中空管道的远端，并在中空管道的远端处形成无导丝导管段；所述导丝上还连接有用于推送管道的非金属均质助推件。
其中，所述无导丝导管段的长度L为3～10cm。本发明的无导丝导管段设计便于内镜下用辅助器械夹持中空管道远端或者远端的单环固定线环从回盲部通过回盲瓣后进入小肠末段，增加手术成功几率，减少手术花费时间。
优选的，所述非金属均质助推件与导丝连接的端部设有便于推送管道的凸台，该凸台的直径大于等于中空管道的直径。
再者，所述非金属均质助推件和导丝之间采用可拆卸式卡槽连接。
进一步，所述中空管道的直径≥2.5mm。
优选的，所述单环固定线环的线环对折长度为1～2.5cm，相邻单环固定线环之间的距离L1大于3cm。本发明的单环固定线环满足内镜下用臂长1cm固定用钛夹对环线夹持操作，避免因线环过长导致固定线因为受力不当而提前脱落，也避免因线环过短导致钛夹无法夹持；同时单环设计也避免线结可能会导致肠腔内容物凝固结块。本发明中单环固定线环之间的距离满足肠道环形皱襞间距在蠕动和延伸过程中减少对两个单环固定线环的相互牵拉，避免因互相牵拉导致单环固定环过早从肠壁上脱落问题。
再者，所述中空管道开设有多个与管内相通的孔道，靠近中空管道远端的导丝端部与邻近孔道之间的距离L2≥2cm。本发明的导丝设计完全避免导丝在操作过程中不会穿出邻近孔道导致医源性损伤。
本发明一种基于用于内镜下经肛门结肠向小肠植入的管道器械的植入方法，包括如下步骤：
(1)首先需要将内镜经肛门-结肠送到小肠的目标位置；
(2)然后需要将管道从内镜钳道孔内送至小肠的目标位置；
(3)将管道留置在原位并推出内镜，完成管道与内镜的分离；
(4)再一次进入内镜并发现内置导丝的中空管道不在小肠目标位置时，用一次性钛夹夹住中空管道远端处的单环固定线环，然后利用内镜进境的机会，随同内镜穿过回盲瓣，进入小肠，到达小肠目标位置，并在内镜下，从内镜钳道孔内输送夹持器械用于将中空管道的线单环固定环依次固定到肠壁上；
(5)固定结束后，内镜缓慢推出肛门外，再拔出导丝，用可以挤插进入中空管道近端的连接帽，方便对接输注器具。
有益效果：与现有技术相比，本发明具有以下显著优点：
(1)本发明管道器械利用导丝、中空管道和非金属均质助推件的组合结构设计便于内镜下将柔软的管道先端向小肠内安全的植入，并将其便捷、安全的固定到小肠柔软曲折的肠壁上，需要突破之前管道只用于结肠植管的器械设计；
(2)本发明的单环固定线环满足内镜下用臂长1cm固定用钛夹对环线夹持操作，避免因线环过长导致固定线因为受力不当而提前脱落，也避免因线环过短导致钛夹无法夹持；同时单环设计也避免线结可能会导致肠腔内容物凝固结块；本发明中单环固定线环之间的距离满足肠道环形皱襞间距在蠕动和延伸过程中减少对两个单环固定线环的相互牵拉，避免因互相牵拉导致单环固定环过早从肠壁上脱落问题；
(3)本发明的无导丝导管段设计便于内镜下用辅助器械夹持中空管道远端或者远端的单环固定线环从回盲部通过回盲瓣后进入小肠末段，增加手术成功几率，减少手术花费时间；
(4)本发明大幅度节省器械加工成本，让器械的价格更适合大众医疗支付。
附图说明
图1为本发明的结构示意图。
具体实施方式
下面结合附图对本发明的技术方案作进一步说明。
如图1所示，本发明一种用于内镜下经肛门结肠向小肠植入的管道器械，包括中空管道3、单环固定线环4、导丝5和非金属均质助推件6。本发明的中空管道3为可弯曲弹性件，该中空管道具有近端1和远端2，其中处于远端的中空管道又称为口侧端，反之，处于肛门口方向的近端又称为肛侧端。中空管道3的直径≥2.5mm，中空管道3开设有多个与管内相通的孔道8，靠近中空管道远端的导丝5端部与邻近孔道8之间的距离L2≥2cm。本发明的导丝的直径远远小于中空管道的内径，导丝在管道内的空间位置会因为弯曲弧度、弯曲的数量、阻力引起皱缩等而发生不可控的变化，也就是说，实际操作过程中，如果将中空管道拉直，其内的导丝也维持直的状态，会获得导丝头端距离中空管道远端的距离，但是如果有不同程度的弯曲，这一距离则变得不稳定。同时，不同材料的中空管道，其在加工成型后，因为放置时间、温度等因素的影响，中空管道还 会出现缩短或延长的可能，在使用时可能会出现导丝在中空管道内过长，甚至长于中空管道，导致肠壁刺伤、穿孔等可能；此外如果刚好从孔道穿出，其导致医源性损伤的可能性则非常大。而本发明的导丝设计可完全避免导丝在操作过程中不会穿出邻近孔道导致医源性损伤。
本发明若干个单环固定线环4间隔固定在中空管道3上，相邻单环固定线环4之间的纵向间距大于3cm。单环固定线环4的线环对折长度为1～2.5cm，相邻单环固定线环4之间的距离L1大于3cm。本发明的单环固定线环满足内镜下用臂长1cm固定用钛夹对环线夹持操作，避免因线环过长导致固定线因为受力不当而提前脱落，也避免因线环过短导致钛夹无法夹持；同时单环设计也避免线结可能会导致肠腔内容物凝固结块；本发明中单环固定线环之间的距离满足肠道环形皱襞间距在蠕动和延伸过程中减少对两个单环固定线环的相互牵拉，避免因互相牵拉导致单环固定环过早从肠壁上脱落问题。
本发明的导丝5为可弯曲的弹性均质导丝，且导丝5可沿中空管道3轴向自由活动。该导丝5从中空管道3的近端1处穿入中空管道3内，且不穿出中空管道3的远端，并在在中空管道3的近端1处形成无导丝导管段。该无导丝导管段的长度L为3～10cm。在实际操作中，当内镜到达目标位置的时候，管道往往不在原位，如果管道因为内镜牵拉的原因，导致管道已经退回到结肠，必须使用异物钳或者一次性钛夹等工具，在内镜直视下夹持中空管道的远端或者中空管道远端的固定线环，利用内镜向小肠移行的机会，持带中空管道进入小肠的目标位置。从大肠通往小肠，最大的技术关口是通过回盲瓣口，瓣口的直径小于肠腔，并且该处的角度大，内镜携带中空管道通过该处并进入小肠扭曲的肠腔时，很容易出现失败或者需要花费很长时间。对于麻醉状态的患者，延长手术时间就面临增加麻醉风险、增加药物与监护的医疗费用。因此本发明的无导丝导管段设计便于内镜下用辅助器械夹持中空管道远端或者远端的单环固定线环从回盲部通过回盲瓣后进入小肠末段，增加手术成功几率，减少手术花费时间。
导丝5上还连接有用于推送管道的非金属均质助推件6，非金属均质助推件6和导丝5之间采用可拆卸式卡槽连接，或者非金属均质助推件6包覆在导丝5外形成整体式连接。非金属均质助推件6与导丝5连接的端部设有便于推送管道的凸台7，该凸台7的直径大于等于中空管道3的直径。本发明导丝5一般选择金属材料，表面光滑。非金属均质助推件6因为在只需在用于推送中空管道及其导丝顺利通过内镜钳道孔并离开内镜，其直径需要小于内镜钳道孔，通常在是小于2.7mm，或者小于3.2mm。非金属均 质助推件6的表面光滑，优选使用塑料或高分子材料件，不含金属。本发明的均质金属导丝5和非金属均质助推件6的设计极大的降低了医疗成本。
本发明的固定一般选择内镜下用一次性内镜夹(如钛夹)在肠腔内固定。对于有特殊治疗需求，比如需要超过2周以上的留置管道，还可以经肛门-结肠途径植入管道后，利用腹腔镜下的缝合技术，在肠内内镜的辅助下进行透壁固定线环，以此实现稳定的固定软导管，这对需要长时间留置管道于小肠内非常重要。本发明用于经肛门-结肠向小肠植入管道并固定，但是不限于将目标位置用于小肠末段，也可以用回盲部、升结肠、横结肠和降结肠的固定。
本发明一种基于用于内镜下经肛门结肠向小肠植入的管道器械的植入方法，包括如下步骤：
(1)首先需要将内镜经肛门-结肠送到小肠的目标位置；
(2)然后需要将管道从内镜钳道孔内送至小肠的目标位置；
(3)将管道留置在原位并推出内镜，完成管道与内镜的分离；
(4)再一次进入内镜并发现内置导丝的中空管道不在小肠目标位置时，用一次性钛夹夹住中空管道远端处的单环固定线环，然后利用内镜进境的机会，随同内镜穿过回盲瓣，进入小肠，到达小肠目标位置，并在内镜下，从内镜钳道孔内输送夹持器械用于将中空管道的线单环固定环依次固定到肠壁上；
(5)固定结束后，内镜缓慢推出肛门外，再拔出导丝，用可以挤插进入中空管道近端的连接帽，方便对接输注器具。
实施例1
本发明中空管道3长度为130cm，口侧端的开口光滑，单环固定线环4的对折长度为1cm，距离口侧端1.5cm处有孔道8，距离口侧端3cm、1cm处各有1个对折长度为1cm单环固定线环。所采用固定线环的材料为医用手术尼龙线，不粘附肠液和肠壁，固定用的钛夹虽然边缘比较锐，但不构成切割线环导致断裂的风险。均质金属导丝5长度为126cm，靠近肛侧端的导丝一端与非金属均质助推件6相连接，非金属均质助推件6为直径2mm的塑料导丝，长度超过常规肠镜长度8cm，即优选180cm。
本发明一种基于用于内镜下经肛门结肠向小肠植入的管道器械的植入方法，包括如下步骤：
(1)首先需要将内镜送到小肠的目标位置，距离回盲瓣10cm处的小肠；
(2)然后需要将管道从内镜钳道孔内送至小肠的目标位置；
(3)将管道留置在原位并推出内镜，完成导管与内镜的分离；
(4)之后再一次进入内镜至回盲部的时候，发现内置导丝的中空管道位于回盲部肠腔内，遂用一次性钛夹夹住中空管道远端的线环，然后利用内镜进境的机会，穿过回盲瓣，进入小肠，到达小肠目标位置，并在内镜下，从内镜钳道孔内输送夹持器械用于将中空管道的固定线环固定到肠壁上，在第一个固定线环用2枚大钛夹固定，在第二个固定线环用1枚大钛夹固定。
本发明的所选择的导丝长度、材料和非金属均质助推件6材料的选择，可节约加工成本60％。
实施例2
本发明中空管道3长度为140cm，口侧端的开口光滑，单环固定线环4的对折长度为1cm，距离口侧端1.5cm处有孔道8，距离口侧端3cm、10cm、20cm处各有1个对折长度为1cm单环固定环。距离口侧端的固定线环适合用在回盲部固定。所采用固定线环的材料为医用手术尼龙线，不粘附肠液和肠壁，固定用的钛夹虽然边缘比较锐，但不构成切割线环导致断裂的风险。均质金属导丝长度为135cm，靠近肛侧端的导丝一端与非金属均质助推件6相连接，非金属均质助推件6为直径2mm的塑料导丝，长度超过常规小肠镜长度8cm，即优选210cm。本发明主要用于小肠经辅助植入小肠深部，用于小肠深部和结肠给药。
本发明一种基于用于内镜下经肛门结肠向小肠植入的管道器械的植入方法，包括如下步骤：
(1)首先需要将内镜送到小肠的目标位置，距离回盲瓣40cm处的小肠；
(2)然后需要将管道从内镜钳道孔内送至小肠的目标位置；
(3)将管道留置在原位并推出内镜，完成管道与内镜的分离；
(4)之后再一次进入内镜至回盲部的时候，发现内置导丝的中空管道位于小肠腔内，遂用一次性钛夹夹住中空管道远端的线环，到达小肠目标位置，并在内镜下，从内镜钳道孔内输送夹持器械用于将中空管道的固定线环固定到肠壁上，在第一个固定线环用2枚大钛夹固定，在第二个固定线环用1枚大钛夹固定，在第三个固定线环处继续用1枚钛夹固定。本发明的所选择的导丝长度、材料和非金属均质助推件6材料的选择，节约加工成本60％。

Claims (8)

  1. 一种用于内镜下经肛门结肠向小肠植入的管道器械，其特征在于：包括具有近端(1)和远端(2)的可弯曲弹性中空管道(3)和固定于中空管道(3)上间距大于3cm的多个单环固定线环(4)，所述中空管道(3)从近端(1)处穿设有可沿轴向自由活动且可弯曲的弹性导丝(5)，该导丝(5)不穿出中空管道(3)的远端(2)，并在中空管道(3)的远端(2)处形成无导丝导管段；所述导丝(5)上还连接有用于推送管道的非金属均质助推件(6)。
  2. 根据权利要求1所述的用于内镜下经肛门结肠向小肠植入的管道器械，其特征在于：所述无导丝导管段的长度L为3～10cm。
  3. 根据权利要求1所述的用于内镜下经肛门结肠向小肠植入的管道器械，其特征在于：所述非金属均质助推件(6)与导丝(5)连接的端部设有便于推送管道的凸台(7)，该凸台(7)的直径大于等于中空管道(3)的直径。
  4. 根据权利要求3所述的用于内镜下经肛门结肠向小肠植入的管道器械，其特征在于：所述非金属均质助推件(6)和导丝(5)之间采用可拆卸式卡槽连接。
  5. 根据权利要求1所述的用于内镜下经肛门结肠向小肠植入的管道器械，其特征在于：所述中空管道(3)的直径≥2.5mm。
  6. 根据权利要求1所述的用于内镜下经肛门结肠向小肠植入的管道器械，其特征在于：所述单环固定线环(4)的线环对折长度为1～2.5cm，相邻单环固定线环(4)之间的距离L1大于3cm。
  7. 根据权利要求1所述的用于内镜下经肛门结肠向小肠植入的管道器械，其特征在于：所述中空管道(3)开设有多个与管内相通的孔道(8)，靠近中空管道远端的导丝(5)端部与邻近孔道(8)之间的距离L2≥2cm。
  8. 一种基于权利要求1至7任一所述的用于内镜下经肛门结肠向小肠植入的管道器械的植入方法，其特征在于，包括如下步骤：
    (1)首先需要将内镜经肛门-结肠送到小肠的目标位置；
    (2)然后需要将管道从内镜钳道孔内送至小肠的目标位置；
    (3)将管道留置在原位并推出内镜，完成管道与内镜的分离；
    (4)再一次进入内镜并发现内置导丝的中空管道不在小肠目标位置时，用一次性钛夹夹住中空管道远端处的单环固定线环，然后利用内镜进境的机会，随同内镜穿过回盲瓣，进入小肠，到达小肠目标位置，并在内镜下，从内镜钳道孔内输送夹持器械用于 将中空管道的线单环固定环依次固定到肠壁上；
    (5)固定结束后，内镜缓慢推出肛门外，再拔出导丝，用可以挤插进入中空管道近端的连接帽，方便对接输注器具。
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EP2502612A1 (en) * 2011-03-24 2012-09-26 INSERM (Institut National de la Santé et de la Recherche Médicale) Medical catheter, applications for tubefeeding and method of manufacture
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CN109620313A (zh) * 2019-01-24 2019-04-16 南京法迈特科技发展有限公司 用于内镜下经肛门结肠向小肠植入的管道器械及植入方法

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EP2502612A1 (en) * 2011-03-24 2012-09-26 INSERM (Institut National de la Santé et de la Recherche Médicale) Medical catheter, applications for tubefeeding and method of manufacture
CN203989206U (zh) * 2014-06-19 2014-12-10 中国人民解放军总医院 一种结肠灌注留置导管
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