WO2019201095A1 - 中消化道植入管道器械及其快速植入方法 - Google Patents

中消化道植入管道器械及其快速植入方法 Download PDF

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Publication number
WO2019201095A1
WO2019201095A1 PCT/CN2019/081303 CN2019081303W WO2019201095A1 WO 2019201095 A1 WO2019201095 A1 WO 2019201095A1 CN 2019081303 W CN2019081303 W CN 2019081303W WO 2019201095 A1 WO2019201095 A1 WO 2019201095A1
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WIPO (PCT)
Prior art keywords
tube
digestive tract
hollow
implanted
wire
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PCT/CN2019/081303
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English (en)
French (fr)
Inventor
张发明
崔伯塔
赵文俊
姚怡昕
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南京法迈特科技发展有限公司
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Publication of WO2019201095A1 publication Critical patent/WO2019201095A1/zh

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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
    • A61J15/00—Feeding-tubes for therapeutic purposes
    • A61J15/0003—Nasal or oral feeding-tubes, e.g. tube entering body through nose or mouth
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
    • A61J15/00—Feeding-tubes for therapeutic purposes
    • A61J15/0026—Parts, details or accessories for feeding-tubes
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
    • A61J15/00—Feeding-tubes for therapeutic purposes
    • A61J15/0026—Parts, details or accessories for feeding-tubes
    • A61J15/003—Means for fixing the tube inside the body, e.g. balloons, retaining means
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
    • A61J15/00—Feeding-tubes for therapeutic purposes
    • A61J15/0026—Parts, details or accessories for feeding-tubes
    • A61J15/0069—Tubes feeding directly to the intestines, e.g. to the jejunum
    • 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
    • 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
    • A61M2210/00—Anatomical parts of the body
    • A61M2210/10—Trunk
    • A61M2210/1042—Alimentary tract
    • A61M2210/1053—Stomach
    • A61M2210/1057—Duodenum

Definitions

  • the invention relates to a pipeline device and an implantation method in the field of medical instruments, in particular to a medium-digestive tract implanted pipeline device and a rapid implantation method thereof.
  • a second object of the present invention is to provide an implantation method for the middle digestive tract implanted catheter device.
  • the present invention discloses a middle digestive tract implanted pipeline device, comprising a flexible elastic hollow tube having a proximal end and a distal end, and at least one fixed at a distal end of the hollow tube at a distance of 15 to 30 cm.
  • a fixing line the first end of the fixing line is inserted into the tube from outside the tube, and the inner wall of the tube is threaded out from the tube after a long section of the tube, and a portion of the tube is threaded along the outer wall of the tube and then passed back into the tube to form at least one single wire loop outside the tube.
  • the wire is wound along the inner wall of the pipe for a period of time, and the outer end of the pipe is connected with the tail end of the fixed wire; the wire knot is close to the distal end of the hollow pipe, the single wire ring is away from the distal end of the hollow pipe, and the wire knot passes through the glue. And/or the film is fixed to the outer wall of the hollow pipe.
  • the fixing wire of the invention can be effectively fixed through the wall of the hollow pipe, and a single wire loop is formed outside the pipe for fixing the distal end of the hollow pipe in the body and is not easy to slide out, and the invention is provided by laying the wire near the distal end.
  • the structure of the single wire loop away from the distal end ensures that the single wire loop of the hollow pipe keeps conforming to the outer wall of the pipe and enters the body during the implantation process.
  • the nasal mucosa is not easily damaged and the bleeding probability is small, and the single wire loop structure is better avoided.
  • the stimuli damage is increased by occupying the nasal space, and the single-wire loop can reduce the possibility of accidentally trapping the nasal polyps and bleeding of the loop;
  • the fixation line of the present invention is fixed at a distance of 15 to 30 cm from the distal end, thereby improving clinical convenience and Operability; by setting the wire knot of the fixed wire outside the tube and fixing it to the outer wall by adhesive and/or film, keeping the inner wall of the tube smooth and wireless, can effectively avoid the easy condensation of the input when the input is rich in protein.
  • nutrients or drugs local solidification and blockage of the pipe occur, effectively reducing the frequency of pipe blockage during use, especially in winter. Northern, more patients avoid the pain of re-planting tube.
  • the hollow tube is provided with a flexible guide wire which is freely movable and bendable in the axial direction from the proximal end, and leaves a part of the guide wire outside the proximal end of the hollow tube; the guide wire is close to the distal end of the hollow tube
  • a flexible guide wire which is freely movable and bendable in the axial direction from the proximal end, and leaves a part of the guide wire outside the proximal end of the hollow tube; the guide wire is close to the distal end of the hollow tube
  • One end of the elastic soft head is provided, and the hardness of the elastic soft head is smaller than the hardness of the hollow pipe, and the hardness of the guide wire is greater than the hardness of the hollow pipe.
  • the guide wire having a hardness greater than that of the hollow pipe plays a certain supporting role for the hollow pipe, and is used for guiding the pipe implant, assisting the hollow pipe when the gastroscope is withdrawn, so that the deformation and bending are not easy to affect the infusion or scratching the inner wall of the human body; and the hardness is less than
  • the function of the elastic soft head of the hollow pipe is to prevent the inner wall from being stabbed during the pipe implantation process and to protect it.
  • the guide wire remaining on the outer side of the proximal end of the hollow tube is provided with a limiting member for preventing the guide wire from sliding into the tube, and the outer surface of the limiting member has a thread.
  • the single wire loop has a diameter of 0.8 to 2 cm.
  • the single-wire loop structure of the invention better avoids the stimulation damage caused by occupying the nasal cavity space, and the single-wire loop can reduce the possibility of the loop loop accidentally trapping the nasal cavity polyps and bleeding; and the single-wire loop with a diameter of 0.8-2 cm effectively avoids the single-wire loop.
  • the diameter is ⁇ 0.8cm
  • the single wire loop is too narrow in the middle digestive tract.
  • the single clip arm of the titanium clip can not be quickly and easily fixed through the single wire loop, which is inconvenient to operate, and the single wire loop is also avoided.
  • the diameter is >2.0cm, the wire loop is too large, and the wire is easy to be wound and curled during the implantation process. After the fixing, the movable distance of the hollow pipe is too large, which increases the risk of falling off.
  • fixation line is an absorbable surgical suture or a non-absorbable surgical suture.
  • the hollow pipe is provided with at least one hole communicating with the inside of the pipe.
  • a joint for the external device is connected to the proximal end of the hollow duct.
  • the hollow pipe is provided with a scale for observing the depth of implantation, and the starting point of the scale is the distal end of the hollow pipe.
  • the invention relates to a rapid implantation method based on a middle digestive tract implanted pipeline device, comprising the following steps:
  • the middle digestive tract implanted instruments are directly sent to the pylorus and merged into the duodenum, so that the single-line ring of the middle digestive tract implanted with the instrument at a distance of 15 to 30 cm from the distal end is visible in the gastroscope.
  • the single wire loop is fixed to the gastric antrum with a titanium clip under direct vision of the gastroscope;
  • the present invention has the following significant advantages: first, the fixing wire of the present invention can be effectively fixed through the wall of the hollow pipe, and a single wire loop is formed outside the pipe for fixing the distal end of the hollow pipe at The body is not easy to slide out, and the invention ensures that the single-wire ring keeps the outer wall of the pipe in the body during the implantation process, and the single-wire ring is kept close to the outer wall of the pipe during the implantation process, and the wire is not close to the distal end, and the single-wire ring is kept away from the outer wall of the pipe during the implantation process. It is easy to cause damage to the nasal mucosa and the probability of bleeding is small.
  • the single-loop structure is better to avoid the stimulation damage caused by occupying the nasal space.
  • the single-wire loop can reduce the possibility of accidental trapping of nasal polyps and bleeding, etc.
  • the fixing line of the present invention It is fixed at a distance of 15 to 30 cm from the distal end to improve clinical convenience and operability.
  • the inner wall of the tube is maintained by placing the knot of the fixed wire outside the tube and fixing it to the outer wall by adhesive and/or film. Smooth wireless junction, which can effectively avoid the local solidification and blockage of the pipe when the input contains nutrients or drugs that are easy to coagulate into proteins.
  • the guide wire having a hardness greater than that of the hollow pipe plays a certain supporting role on the hollow pipe. It is used to guide the catheter implantation, assist the hollow tube when the gastroscope exits, so that it is not easy to deform and bend, affecting the infusion or scratching the inner wall of the human body; and the elastic soft head with hardness less than the hollow tube is to prevent the inner wall from being stabbed during the pipe implantation process. To protection.
  • Figure 1 is a schematic view showing the structure of a hollow pipe and a fixing wire according to the present invention
  • Figure 2 is a partially enlarged schematic view showing a fixing line of the present invention
  • Figure 3 is a partially enlarged schematic view showing two fixing lines in the present invention.
  • FIG. 4 is a schematic view showing a manner of routing a fixed line in the present invention.
  • Figure 5 is a schematic structural view of a guide wire in the present invention.
  • Fig. 6 is a schematic view showing the structure of a guide wire penetrating into a hollow pipe in the present invention.
  • a middle digestive tract implanted catheter device comprises a hollow tube 3, a fixation line 4 and a guide wire 7.
  • the hollow pipe 3 with open ends at both ends is a polymer material pipe which is bendable, soft and elastic, and has smooth inner and outer surfaces.
  • the hollow pipe 3 has a proximal end 1 and a distal end 2, and is opened on the outer wall of the hollow pipe.
  • At least one channel communicating with the tube facilitates the overflow of the drug in the tube through the channel and is delivered to the human body.
  • the channel is more than two, and the shape of the channel may be circular, elliptical or other irregular shape.
  • the hollow pipe may have a length of 90 to 150 cm and a cross-sectional diameter of 1.5 mm to 5.0 mm.
  • the invention may or may not be provided with a tracer substance, such as a metal line that is impermeable to X-rays, on the wall of the hollow pipe.
  • the joint 10 for the external device is connected to the proximal end of the hollow duct 3 to meet various requirements such as the intubation, the advance and retreat guide wire, and the infusion.
  • the hollow duct 3 of the present invention is provided with a scale for observing the depth of implantation, and the starting point of the scale is the distal end 2 of the hollow duct 3.
  • the fixing wire 4 of the present invention is an absorbable surgical suture or a non-absorbable surgical suture, and has a certain tensile force, wherein the absorbable surgical suture can be selected from a gut, a chemical synthetic line (PGA, PGLA, PLA) or pure natural collagen suture; non-absorbable surgical sutures can be made of materials such as polypropylene, nylon, stainless steel, silk or polyester.
  • the absorbable surgical suture can be selected from a gut, a chemical synthetic line (PGA, PGLA, PLA) or pure natural collagen suture
  • non-absorbable surgical sutures can be made of materials such as polypropylene, nylon, stainless steel, silk or polyester.
  • the fixing wire 4 is fixed at a distance of 15 to 30 cm from the distal end of the hollow pipe 3, and the first end of the fixing wire 4 is inserted into the pipe from the outside of the pipe, and is passed through the pipe after the inner wall of the pipe is crossed for a while, and then the wire is stretched along the outer wall of the pipe for a period of time.
  • the present invention provides a fixing line on the outer wall of the tube, and the fixing line is routed along the axial direction thereof, so as to avoid the line segment of the inner wall of the tube affecting the cross-sectional area of the inner wall of the tube and maximize the smoothness of the inner wall of the tube.
  • the present invention provides two fixed lines independent of each other on the outer wall of the tube, and the two fixed lines are arranged along the axial direction of the tube, and two independent single-wire rings 5 are formed, which can be inserted during the pipeline device implantation process. According to actual needs, any single wire loop 5 is selected to be fixed in the human body by a titanium clip. Or as shown in Fig.
  • the fixed line is routed away from the radial center line in the inner wall of the hollow pipe.
  • This way of routing is a sub-optimal routing method. Although occupying a small amount of inner wall cross-sectional area, it is generally approved to ensure that the inner wall of the pipe is unobstructed.
  • the fixing wire of the invention can be effectively fixed through the wall of the hollow pipe, and a single wire loop is formed outside the pipe for fixing the distal end of the hollow pipe in the body, and the invention is not close to the distal end by the wire knot.
  • the structure of the single wire loop away from the distal end ensures that the single wire loop of the hollow pipe keeps conforming to the outer wall of the pipe and enters the body during the implantation process.
  • the single-line ring can reduce the possibility of the wire loop accidentally trapping the nasal polyps and bleeding;
  • the fixation line of the invention is fixed at a distance of 15 to 30 cm from the distal end, thereby improving clinical convenience and The operability; further, by setting the knot of the fixed wire outside the tube and fixing it to the outer wall by adhesive and/or film, keeping the inner wall of the tube smooth and wireless, can effectively avoid the easy condensation of the input when the input is rich in protein.
  • nutrients or drugs are present, local solidification and blockage of pipes occur in the tube, effectively reducing the frequency of pipe blockage during use, especially in winter or north. Area, more patients avoid the pain of re-planting tube.
  • the single wire loop 5 has a diameter of 0.8 to 2 cm, which effectively avoids the single wire loop being too narrow in the middle digestive tract due to the single wire loop diameter ⁇ 0.8 cm, and the single clamp arm of the titanium clip cannot be quickly and conveniently fixed when the titanium clip is fixed by implantation. It is easy to operate through a single wire loop, and it is also inconvenient to operate. At the same time, the wire loop is too large when the diameter of the single wire ring is >2.0cm. The wire is easily entangled and curled during the implantation process. The movable distance of the hollow pipe after the fixation is too large, which increases the risk of falling off. And other issues.
  • the guide wire 7 of the present invention penetrates from the proximal end 1 of the hollow tube 3, leaving a portion of the guide wire outside the proximal end of the hollow tube, leaving a guide outside the proximal end of the hollow tube 3.
  • the wire 7 is provided with a limiting member 9 for preventing the guide wire 7 from sliding into the tube, and the outer surface of the limiting member has a thread; the threaded limiting member of the invention is arranged to prevent the guide wire from sliding into the hollow pipe. At the same time, the thread can easily handle the guide wire.
  • the guide wire 7 is freely movable along the axial direction of the hollow pipe 3, and the guide wire is a flexible or flexible biomaterial-compatible polymer material wire or wire, and the guide wire can be lubricated by the lubricating oil in the hollow pipe. (such as medical paraffin oil) or other lubrication techniques (such as ultra-slip surface technology to lubricate when exposed to water).
  • the end of the guide wire 7 near the distal end of the hollow duct 3 is provided with an elastic soft head 8, the hardness of which is smaller than the hardness of the hollow duct 3, and the hardness of the guide wire 7 is greater than the hardness of the hollow duct 3.
  • the guide wire having a hardness greater than that of the hollow pipe plays a certain supporting role for the hollow pipe, and is used for guiding the pipe implant, assisting the hollow pipe when the gastroscope is withdrawn, so that the deformation and bending are not easy to affect the infusion or scratching the inner wall of the human body; and the hardness is less than
  • the function of the elastic soft head of the hollow pipe is to prevent the inner wall from being stabbed during the pipe implantation process and to protect it.
  • the middle digestive tract implanted pipeline device of the invention can be sent to the middle digestive tract and fixed quickly, and the nasal mucosal injury and hemorrhage can be avoided to the greatest extent during the implantation process, and the material in the pipeline is greatly reduced during the infusion process after the planting tube is completed. Condensed into blocks to block the pipe.
  • the invention has the advantages of ingenious structure, convenient operation, safety and effectiveness, long-term retention, and meets the requirements of multiple administrations, and greatly facilitates clinical applications such as nasal feeding tube implantation and whole colon administration, and is suitable for clinical treatment.
  • the invention relates to a rapid implantation method based on a middle digestive tract implanted pipeline device, which comprises the following steps:
  • the patient needs to be inserted into the middle digestive tract into the stomach by snorkeling, and then the gastroscope is sent from the oral cavity into the stomach; if the patient is selected under anesthesia After the anesthesia, the gastroscope is sent to the oral cavity, and the gastroscope is inserted into the middle digestive tract into the front of the pear-shaped crypt under the direct vision of the gastroscope. Under the direct vision of the gastroscope, the device of the middle digestive tract is inserted into the esophagus. The middle digestive tract implanted device is inserted into the esophagus along with the gastroscope and enters the stomach;
  • the middle digestive tract implanted instruments are directly sent to the pylorus and merged into the duodenum, so that the middle digestive tract is implanted into the tube instrument.
  • the single-wire ring 5 on the fixed line at the distal end of 15 to 30 cm is in the endoscope.
  • the single-wire ring 5 In the visible state, the single-wire ring 5 is fixed in the gastric antrum with the titanium clip under the direct vision of the gastroscope; for the population over 7 years old, the delivery line of the middle digestive tract implanted instrument is 85-95 cm, so that the middle digestive tract is implanted.
  • the distal end of the tube instrument reaches the proximal end of the jejunum; if it cannot be directly transported into place, the foreign body clamp should be used to clamp the distal end of the middle digestive tract into the duodenum and transfer to the duodenum.
  • the intragastric curvature causes the middle digestive tract to be implanted from the duodenum back into the stomach, and can not be transported too short to cause resistance to return from the duodenum to the stomach back to the stomach;
  • the guide wire 7 wherein the guide wire in the hollow pipe temporarily retains a certain supporting effect on the hollow pipe, effectively avoiding the wrinkle distortion phenomenon of the hollow pipe during the mirror retreat, and preventing the endoscope from being pulled out of the body due to friction Taking out the phenomenon of pulling the hollow pipe and shifting it;
  • the hollow pipe 3 is directly taken out, and the titanium pipe clamp on the fixed wire 4 and the single wire ring can be taken out along the hollow pipe 3, and no adverse reaction is observed.
  • the middle digestive tract implanted pipeline device of the present invention can be used for inputting a flora for bacterial transplantation, contrast agent for intestinal development, and the like.
  • the digestive tract implanted pipeline device of the invention has the advantages of ingenious structure, convenient operation, safety and effectiveness, and can be retained for a long time, and can be mainly used for implanting a hose through the endoscope to assist the middle digestive tract (intestine below the duodenal papilla).
  • the distal segment can reach the distal end of the duodenum or the proximal end of the jejunum, and is used for nasal feeding and intra-intestinal administration through the tube, which can solve the problem of nasal mucosal damage bleeding and easy implantation after rapid endoscopic implantation of the nasogastric feeding tube under conventional endoscopy. There is a problem of condensation in the lumen to block the tube.
  • the time for completing the above planting operation is short, generally only 2-4 minutes, which is obviously shortened compared with the traditional planting time of about 10 minutes, reducing the suffering of the patient, reducing the amount of drugs using sedative anesthesia, and helping to reduce the operational risk. It also saves doctor time.
  • the in-line enteral nutrient solution is input in the pipeline of the invention, and the incidence of tube clogging is reduced by 81% within 7 days under low temperature conditions; in addition, the wire knot is located outside the tube wall, by means of bonding and/or The film is covered and the single loop is kept in the forward direction, and the incidence of nasal mucosal bleeding can be effectively avoided during the implantation process.

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Abstract

本发明公开了一种中消化道植入管道器械，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距离远端15～30cm处的至少一个固定线，所述固定线的首端从管外穿入管内，在管内壁走线一段后从管内穿出，沿管外壁走线一段后再穿回管内并在管外形成一单线环，再沿管内壁走线一段后穿出管外与固定线的尾端打成线结；其中线结靠近中空管道的远端，单线环远离中空管道的远端，且所述线结通过粘胶和/或覆膜固定于中空管道外壁。本发明中消化道植入管道器械的结构巧妙、操作方便、安全有效，可长期保留，解决传统内镜下快速植入鼻肠饲管时鼻粘膜损害出血和植入后容易发生管腔内凝结成块堵管的问题。

Description

中消化道植入管道器械及其快速植入方法 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，尤其涉及一种中消化道植入管道器械及其快速植入方法。
背景技术
传统的经鼻肠(通常含十二指肠和空肠近段)管给入途径，主要用于肠内营养液输注和药物给入，可以保留较长时间使用，但是，输注管无法固定在肠壁，也容易滑脱到胃内或者体外；操作时间常常超过10分钟，期间患者痛苦，操作风险增加。有的管道需要在内镜钳道植入到十二指肠后，还需要将口腔内的管道通过置换装置改道于鼻腔，给患者带来了痛苦。有的空肠管在内镜下难以成功放置到目的位置，即使能够到达，在退镜的时候也会导致导管被带离目标位置。
因此，亟需解决上述问题
发明内容
发明目的：本发明的第一目的是提供一种可解决传统内镜下快速植入鼻肠饲管时鼻粘膜损害出血和植入后容易发生管腔内凝结成块堵管的问题的中消化道植入管道器械。
本发明的第二目的是提供该中消化道植入管道器械的植入方法。
技术方案：为实现以上目的，本发明公开了一种中消化道植入管道器械，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距离远端15～30cm处的至少一个固定线，所述固定线的首端从管外穿入管内，在管内壁走线一段后从管内穿出，沿管外壁走线一段后再穿回管内并在管外形成至少一个单线环，再沿管内壁走线一段后穿出管外与固定线的尾端打成线结；其中线结靠近中空管道的远端，单线环远离中空管道的远端，且所述线结通过粘胶和/或覆膜固定于中空管道外壁。首先本发明的固定线穿过中空管道管壁可有效固定，同时在管外形成单线环用于将中空管道的远端固定在体内不易滑出，且本发明通过将线结设于靠近远端，单线环远离远端的结构，保障中空管道在植入过程中单线环保持顺向贴合管道外壁进入体内，经过鼻腔时不容易导致鼻腔粘膜受损害且出血概率小，单线环结构更好避免因占据鼻腔空间而增加刺激损伤，单线环可减少线环意外套捕鼻腔息肉而出血等的可能性；其次本发明的固定线固定于距离远端15～30cm处，提高临床上的便捷性和可操作性；再者通过将固定线的线结设置管外，并通过粘胶 和/或覆膜固定于外壁，保持管内壁光滑无线结，可有效避免当输入含有丰富蛋白质等容易凝结成块的营养物或者药物时，管内出现局部凝固和堵塞管道的现象，有效降低使用时管道堵塞发生频率，尤其是在冬天或北方地区，更加避免患者再次植管的痛苦。
其中，固定线在中空管道内壁沿其轴向方向走线或者在中空管道内壁偏离径向中心线方向走线。本发明管内壁的固定线优选沿其轴向方向走线，可避免管内壁的线段影响管内壁截面积，最大化保障管内壁的畅通。
优选的，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，并留有部分导丝在中空管道近端外侧；所述导丝靠近中空管道远端的一端设有弹性软头，该弹性软头的硬度小于中空管道的硬度，导丝的硬度大于中空管道的硬度。本发明中硬度大于中空管道的导丝对中空管道起到一定的支撑作用，用于引导管道植入、胃镜退出时辅助中空管道，使其不易变形弯曲影响输液或划伤人体内壁；而硬度小于中空管道的弹性软头的作用是防止管道植入过程中刺伤内壁，起到保护作用。
优选的，所述留在中空管道近端外侧的导丝上设有用于防止导丝滑入管内的限位件，该限位件的外表面具有螺纹。
再者，所述单线环的直径为0.8～2cm。本发明单线环结构更好避免因占据鼻腔空间而增加刺激损伤，单线环可减少线环意外套捕鼻腔息肉而出血等的可能性；且直径为0.8～2cm的单线环有效避免了因单线环直径＜0.8cm时单线环在中消化道内过于狭小，植入施加钛夹固定时无法快速便捷让钛夹的单夹臂穿过单线环固定，操作不方便等问题；同时还避免了因单线环直径＞2.0cm时线环过大，植入过程中线容易缠绕卷曲，固定后中空管道可移动距离过大增加了脱落风险等问题。
进一步，所述固定线为可吸收手术缝线或不可吸收手术缝线。
优选的，所述中空管道开设有至少一个与管内相通的孔道。
再者，所述中空管道的近端上连接用于外接设备的接头。
优选的，所述中空管道上设有便于观察植入深度的刻度，刻度起点为中空管道的远端。
本发明一种基于中消化道植入管道器械的快速植入方法，包括如下步骤：
(1)、若选择清醒条件下植入，患者需要在清醒时经鼻盲插入中消化道植入管道器械至胃内，然后再将胃镜从口腔送入胃内；若选择麻醉条件下植入，则在麻醉后将胃镜送至口腔，在胃镜直视下经鼻盲插入中消化道植入管道器械至梨状隐窝前方，胃镜直 视条件下确认中消化道植入管道器械进入食管，再将中消化道植入管道器械随胃镜一同插入到食管，并进入胃内；
(2)、首先将中消化道植入管道器械直接送往幽门并入十二指肠内，使中消化道植入管道器械距离远端15～30cm处的固定线上的单线环处于胃镜可见状态下，在胃镜直视下用钛夹将单线环固定在胃窦；
(3)用钛夹固定中消化道植入管道器械后，持住中空管道在鼻部不动，小心退镜，退镜的同时通过胃镜观察胃内中空管道有无大角度弯曲，若有弯曲，则在体外酌情向体外拔中空管道；退镜的同时缓慢外拔导丝，通过胃镜可直视中空管道内导丝移动，当导丝移出20～30cm后暂停外拔导丝；
(4)当胃镜退出至体外后再将导丝完全拔出，通过管用胶布将中空管道固定于鼻脊，中空管道的近端连接外接设备，植管结束；
(5)使用完毕后直接外拔中空管道，随中空管道可带出固定线和单线环上的钛夹。
有益效果：与现有技术相比，本发明具有以下显著优点：首先本发明的固定线穿过中空管道管壁可有效固定，同时在管外形成单线环用于将中空管道的远端固定在体内不易滑出，且本发明通过将线结设于靠近远端，单线环远离远端的结构，保障中空管道在植入过程中单线环保持顺向贴合管道外壁进入体内，经过鼻腔时不容易导致鼻腔粘膜受损害且出血概率小，单线环结构更好避免因占据鼻腔空间而增加刺激损伤，单线环可减少线环意外套捕鼻腔息肉而出血等的可能性；其次本发明的固定线固定于距离远端15～30cm处，提高临床上的便捷性和可操作性；再者通过将固定线的线结设置管外，并通过粘胶和/或覆膜固定于外壁，保持管内壁光滑无线结，可有效避免当输入含有丰富蛋白质等容易凝结成块的营养物或者药物时，管内出现局部凝固和堵塞管道的现象，有效降低使用时管道堵塞发生频率，尤其是在冬天或北方地区，更加避免患者再次植管的痛苦；还有本发明中硬度大于中空管道的导丝对中空管道起到一定的支撑作用，用于引导管道植入、胃镜退出时辅助中空管道，使其不易变形弯曲影响输液或划伤人体内壁；而硬度小于中空管道的弹性软头的作用是防止管道植入过程中刺伤内壁，起到保护作用。
附图说明
图1为本发明中空管道和固定线的结构示意图；
图2为本发明中一个固定线的局部放大示意图；
图3为本发明中两个固定线的局部放大示意图；
图4为本发明中一种固定线的走线方式的示意图；
图5为本发明中导丝的结构示意图；
图6为本发明中导丝穿入中空管道的结构示意图。
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，本发明一种中消化道植入管道器械，包括中空管道3、固定线4和导丝7。本发明的两端开口的中空管道3为可弯曲、具有柔软弹性且内外表面光滑的高分子材料管道，该中空管道3具有一近端1和一远端2，在中空管道的外壁上开设有至少一个与管内相通的孔道，便于管内药物通过孔道溢出，输送至人体内，孔道优选2个以上，孔道的形态可以为圆形、椭圆形或者其它不规则形状。中空管道的长度可为90～150cm，横截面直径为1.5mm～5.0mm。本发明可在中空管道的管壁上设有或不设示踪物质，比如不透X光的金属线。中空管道3的近端上连接用于外接设备的接头10，满足插管、进退导丝、输注等各种需求。本发明的中空管道3上设有便于观察植入深度的刻度，刻度起点为中空管道3的远端2。
如图2所示，本发明的固定线4为可吸收手术缝线或不可吸收手术缝线，且具有一定拉伸力，其中可吸收手术缝线可选用羊肠线、化学合成线(PGA、PGLA、PLA)或纯天然胶原蛋白缝合线；不可吸收手术缝线可选用聚丙烯、尼龙、不锈钢、蚕丝或聚酯等材料制成的线。固定线4固定于中空管道3距离远端15～30cm处，该固定线4的首端从管外穿入管内，在管内壁走线一段后从管内穿出，沿管外壁走线一段后再穿回管内并在管外形成至少一个单线环5；再沿管内壁走线一段后穿出管外与固定线的尾端打成线结6；其中线结6靠近中空管道3的远端2，单线环5远离中空管道3的远端2，且线结6通过粘胶和/或覆膜固定于中空管道3外壁。如图2所示，本发明在管外壁上设置一个固定线，固定线沿其轴向方向走线，可避免管内壁的线段影响管内壁截面积，最大化保障管内壁的畅通。如图3所示，本发明在管外壁设置互相独立的2个固定线，两固定线沿管道轴向方向排列，且形成两个互相独立的单线环5，在管道器械植入过程中，可根据实际需要选择任一单线环5通过钛夹固定于人体内。或者如图4所示，固定线在中空管道内壁偏离径向中心线方向走线，此走线方式为次优的走线方式，虽占据少量内壁截面积，但认可大致保障管内壁通畅。
本发明的固定线穿过中空管道管壁可有效固定，同时在管外形成单线环用于将中空 管道的远端固定在体内不易滑出，且本发明通过将线结设于靠近远端，单线环远离远端的结构，保障中空管道在植入过程中单线环保持顺向贴合管道外壁进入体内，经过鼻腔时不容易导致鼻腔粘膜受损害且出血概率小，单线环结构更好避免因占据鼻腔空间而增加刺激损伤，单线环可减少线环意外套捕鼻腔息肉而出血等的可能性；其次本发明的固定线固定于距离远端15～30cm处，提高临床上的便捷性和可操作性；再者通过将固定线的线结设置管外，并通过粘胶和/或覆膜固定于外壁，保持管内壁光滑无线结，可有效避免当输入含有丰富蛋白质等容易凝结成块的营养物或者药物时，管内出现局部凝固和堵塞管道的现象，有效降低使用时管道堵塞发生频率，尤其是在冬天或北方地区，更加避免患者再次植管的痛苦。本发明中单线环5的直径为0.8～2cm，有效避免了因单线环直径＜0.8cm时单线环在中消化道内过于狭小，植入施加钛夹固定时无法快速便捷让钛夹的单夹臂穿过单线环固定，操作不方便等问题；同时还避免了因单线环直径＞2.0cm时线环过大，植入过程中线容易缠绕卷曲，固定后中空管道可移动距离过大增加了脱落风险等问题。
如图5和图6所示，本发明的导丝7从中空管道3的近端1处穿入，并留有部分导丝在中空管道近端外侧，留在中空管道3近端外侧的导丝7上设有用于防止导丝7滑入管内的限位件9，该限位件的外表面具有螺纹；本发明设置带螺纹的限位件的作用是防止导丝滑入中空管道内，同时螺纹可易于操作导丝。该导丝7可沿中空管道3轴向自由活动，导丝为具有弹性且可弯曲的生物组织相容性好的高分子材料丝或金属丝，导丝在中空管道内活动时可借助润滑油(如医用石蜡油)或者其他润滑技术(如超滑表面技术遇水即润滑)。导丝7靠近中空管道3远端的一端设有弹性软头8，该弹性软头8的硬度小于中空管道3的硬度，导丝7的硬度大于中空管道3的硬度。本发明中硬度大于中空管道的导丝对中空管道起到一定的支撑作用，用于引导管道植入、胃镜退出时辅助中空管道，使其不易变形弯曲影响输液或划伤人体内壁；而硬度小于中空管道的弹性软头的作用是防止管道植入过程中刺伤内壁，起到保护作用。
本发明的中消化道植入管道器械，能送快捷送到中消化道并固定，植入过程中最大程度避免鼻腔粘膜损伤出血，植管完成后在输注过程中，大幅度减少管道内物质凝结成块而堵塞管道。本发明结构巧妙、操作方便、安全有效，可长期保留，并满足多次给药的需求，极大的方便了鼻饲管植入、全结肠给药等临床用途，适合广泛用于临床治疗。
本发明一种基于中消化道植入管道器械的快速植入方法，其特征在于，包括如下步 骤：
(1)、若选择清醒条件下植入，患者需要在清醒时经鼻盲插入中消化道植入管道器械至胃内，然后再将胃镜从口腔送入胃内；若选择麻醉条件下植入，则在麻醉后将胃镜送至口腔，在胃镜直视下经鼻盲插入中消化道植入管道器械至梨状隐窝前方，胃镜直视条件下确认中消化道植入管道器械进入食管，再将中消化道植入管道器械随胃镜一同插入到食管，并进入胃内；
(2)、首先将中消化道植入管道器械直接送往幽门并入十二指肠内，使中消化道植入管道器械距离远端15～30cm处的固定线上的单线环5处于胃镜可见状态下，在胃镜直视下用钛夹将单线环5固定在胃窦；用于7岁以上的人群，中消化道植入管道器械输送截止刻度为85～95cm，使中消化道植入管道器械远端即到达空肠近端；如果不能直接输送到位，则需用异物钳夹持中消化道植入管道器械的远端并移送至十二指肠，送管时注意不能输送过多容易导致胃内盘曲反而导致中消化道植入管道器械从十二指肠弹回胃内，也不可输送过短以至于产生阻力从十二指肠反向牵拉管道返回到胃内；
(3)、用钛夹固定中消化道植入管道器械后，持住中空管道3在鼻部不动，小心退镜，退镜的同时通过胃镜观察胃内中空管道有无大角度弯曲，若有弯曲，则在体外酌情向体外拔中空管道3；退镜的同时缓慢外拔导丝7，通过胃镜可直视中空管道3内导丝7移动，当导丝移出20～30cm后暂停外拔导丝7；其中暂时留着中空管道内的导丝对中空管道起到一定的支撑作用，有效避免退镜过程中中空管道发生皱折扭曲现象，同时防止内镜往体外拔出时因为摩擦力带出牵拉中空管道而移位的现象；
(4)、当胃镜退出至体外后再将导丝7完全拔出，通过管用胶布将中空管道3固定于鼻脊，中空管道3的近端1连接外接设备，植管结束，无需用X线等其它检查手段确认肠道内深度植入器管是否定位于空肠近端；
(5)、使用完毕后直接外拔中空管道3，随中空管道3可带出固定线4和单线环上的钛夹，且未见不良反应。
本发明的中消化道植入管道器械可用于输入菌群用于菌群移植、造影剂用于肠道内显影等。本发明中消化道植入管道器械的结构巧妙、操作方便、安全有效，可长期保留，主要可用于经过内镜辅助在中消化道(十二指肠乳头以下的肠道)植入软管，其远段可以到达十二指肠远端或者空肠近端，用于鼻饲和经该管肠道内给药，解决传统内镜下快速植入鼻肠饲管时鼻粘膜损害出血和植入后容易发生管腔内凝结成块堵管的问题。
本发明完成以上植管操作的时间简短，一般只需要2-4分钟，较传统的植管时间10分钟左右明显缩短，减少病患痛苦，减少使用镇静麻醉的药物量，有助于降低操作风险，还能节省医生时间。同时临床显示采用本发明的管道内输入整蛋白肠内营养液，在低温条件下，7天内发生管道堵塞发生率降低81％；此外在线结位于管壁外的条件下，借助粘结和/或覆膜以及保持单线环顺向，植入过程中可有效避免了鼻腔粘膜出血发生率增加。

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  1. 一种中消化道植入管道器械，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)距离远端15～30cm处的至少一个固定线(4)，所述固定线(4)的首端从管外穿入管内，在管内壁走线一段后从管内穿出，沿管外壁走线一段后再穿回管内并在管外形成一单线环(5)，再沿管内壁走线一段后穿出管外与固定线的尾端打成线结(6)；其中线结(6)靠近中空管道(3)的远端(2)，单线环(5)远离中空管道(3)的远端(2)，且所述线结(6)通过粘胶和/或覆膜固定于中空管道(3)外壁。
  2. 根据权利要求1所述的中消化道植入管道器械，其特征在于：所述固定线(4)在中空管道内壁沿其轴向方向走线或者在中空管道内壁偏离径向中心线方向走线。
  3. 根据权利要求1所述的中消化道植入管道器械，其特征在于：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(7)，并留有部分导丝在中空管道近端外侧；所述导丝(7)靠近中空管道(3)远端的一端设有弹性软头(8)，该弹性软头(8)的硬度小于中空管道(3)的硬度，导丝(7)的硬度大于中空管道(3)的硬度。
  4. 根据权利要求3所述的中消化道植入管道器械，其特征在于：所述留在中空管道(3)近端外侧的导丝(7)上设有用于防止导丝(7)滑入管内的限位件(9)，该限位件(9)的外表面具有螺纹。
  5. 根据权利要求1所述的中消化道植入管道器械，其特征在于：所述单线环(5)的直径为0.8～2cm。
  6. 根据权利要求1所述的中消化道植入管道器械，其特征在于：所述固定线(4)为可吸收手术缝线或不可吸收手术缝线。
  7. 根据权利要求1所述的中消化道植入管道器械，其特征在于：所述中空管道(3)开设有至少一个与管内相通的孔道。
  8. 根据权利要求1所述的中消化道植入管道器械，其特征在于：所述中空管道(3)的近端上连接用于外接设备的接头(10)。
  9. 根据权利要求1所述的中消化道植入管道器械，其特征在于：所述中空管道(3)上设有便于观察植入深度的刻度，刻度起点为中空管道(3)的远端(2)。
  10. 一种基于权利要求1至9任一所述的中消化道植入管道器械的快速植入方法，其特征在于，包括如下步骤：
    (1)、若选择清醒条件下植入，患者需要在清醒时经鼻盲插入中消化道植入管道器械至胃内，然后再将胃镜从口腔送入胃内；若选择麻醉条件下植入，则在麻醉后将胃镜送至口腔，在胃镜直视下经鼻盲插入中消化道植入管道器械至梨状隐窝前方，胃镜直视条件下确认中消化道植入管道器械进入食管，再将中消化道植入管道器械随胃镜一同插入到食管，并进入胃内；
    (2)、首先将中消化道植入管道器械直接送往幽门并入十二指肠内，使中消化道植入管道器械距离远端15～30cm处的固定线上的单线环(5)处于胃镜可见状态下，在胃镜直视下用钛夹将单线环(5)固定在胃窦；
    (3)用钛夹固定中消化道植入管道器械后，持住中空管道(3)在鼻部不动，小心退镜，退镜的同时通过胃镜观察胃内中空管道有无大角度弯曲，若有弯曲，则在体外酌情向体外拔中空管道(3)；退镜的同时缓慢外拔导丝(7)，通过胃镜可直视中空管道(3)内导丝(7)移动，当导丝移出20～30cm后暂停外拔导丝(7)；
    (4)当胃镜退出至体外后再将导丝(7)完全拔出，通过管用胶布将中空管道(3)固定于鼻脊，中空管道(3)的近端(1)连接外接设备，植管结束；
    (5)使用完毕后直接外拔中空管道(3)，随中空管道(3)可带出固定线(4)和单线环上的钛夹。
PCT/CN2019/081303 2018-04-20 2019-04-03 中消化道植入管道器械及其快速植入方法 WO2019201095A1 (zh)

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