Device and method for establishing endoscopic tunnel in enteroscopy or operation

Abstract

The invention relates to a device and a method for establishing an endoscopic tunnel in enteroscopy or an endoscopic surgery, which are used for assisting in entering an endoscope in the enteroscopy or the endoscopic surgery, effectively controlling leakage of injected gas, establishing an endoscopic diagnosis or surgery tunnel between a tip navigation balloon and a peripheral plugging balloon, and improving a local diagnosis visual field in an intestinal tract or a surgery field of the endoscopic surgery. Not only is the efficiency of endoscopic diagnosis or endoscopic surgery improved, but also adverse consequences such as abdominal distension and abdominal pain caused by a large amount of air inflow are avoided, and the risk of endoscopic diagnosis or surgery is reduced. The device is easy to operate, safe, reliable and worthy of clinical application and popularization.

Description

Technical Field

[0001] The present application relates to a device and method for establishing an endoscopic tunnel during colonoscopy or surgery, and is a disposable sterile medical device used in hospitals. Background Art

[0002] Colorectal cancer (CRC) is a common malignant tumor. Due to factors such as environmental pollution and residual harmful substances in food, its morbidity and mortality rates have been increasing year by year. CRC has become one of the most common malignant tumors in the world, and its morbidity and mortality rates rank third and second among malignant tumors in the world, respectively. Regular screening and early treatment are the key to improving the prognosis and economic burden of CRC patients. The Chinese Expert Consensus on Early Diagnosis and Treatment of Colorectal Cancer (2023 Edition) clearly states that colonoscopy is the gold standard for CRC screening. It is also pointed out that endoscopic treatment is indicated for patients with CRC without lymph node metastasis and for one-time resection of early CRC according to the size and location of the tumor. Resection of adenomatous polyps or polyps with a diameter ≥5 mm (whether adenomatous or not) is recommended.

[0003] Due to the folds and grooves of the mucosa on the inner wall of the human intestine, a certain amount of nitrogen or carbon dioxide gas must be injected during colonoscopy or endoscopic resection to open the intestinal cavity and the contracted mucosal folds, so that the doctor can have sufficient surgical field space and clearly observe the morphology of the inner wall of the colon or perform surgery under the endoscope. However, in existing clinical practice, when gas is injected into the intestine, part of the gas will quickly move upstream to the small intestine and stomach, and part of the gas will quickly be discharged downstream along the peripheral space of the endoscope to the anus. Therefore, during colonoscopy or endoscopic resection, gas needs to be injected into the intestine continuously. This not only seriously affects the progress of colonoscopy or endoscopic surgery and increases the labor intensity of doctors, but also a large amount of gas injection can easily induce complications of colonoscopy or endoscopic surgery, including unbearable abdominal pain, vomiting, etc. If too much gas is delivered, the intestinal tube will overstretch and expand, the intestinal wall will become thinner, and improper insertion of the colonoscope will cause intestinal perforation in severe cases. Therefore, it is not unreasonable for industry professionals to say that "controlling the amount of gas is controlling the large intestine." At the same time, due to the twists and turns of the human colon, the colonoscope is inserted from the anus, passes through the rectum, sigmoid colon, descending colon, splenic flexure of the colon, transverse colon, hepatic region of the colon, cecum, and is withdrawn at the ileocecal region or the end of the small intestine. Doctors need years of practice to master the technique of inserting the endoscope. The process is not only time-consuming and laborious, but improper operation of the endoscope will increase the patient's pain and even cause intestinal perforation, leading to serious medical consequences.

[0004] In order to solve the problems of difficulty in inserting the endoscope and gas control during colonoscopy or surgery, help doctors insert the endoscope smoothly, and establish a good colonoscopy diagnosis or surgical field of view, the present application proposes a device and method for establishing an endoscopic tunnel during colonoscopy or surgery to overcome the shortcomings of the prior art. Summary of the invention

[0005] A device for establishing an endoscopic tunnel during colonoscopy or surgery comprises a front navigation balloon, a peripheral blocking balloon and an injector.

[0006] The front navigation balloon is mainly composed of a pilot balloon, a support rod and a sealing device, wherein: The pilot balloon is a hollow film cavity made of elastic medical polymer materials. The film cavity can be expanded by water or air injection, and folded and restored after the water or air is extracted. The polymer materials used include nylon, polyurethane, latex, silicone and other non-toxic medical polymer composite materials.

[0007] The support rod is a tubular material made of medical polymer materials. The inside of the support rod is provided with a diversion cavity. The support rod should have at least one diversion hole for connecting the diversion cavity with the inner cavity of the pilot balloon. The polymer materials used for the support rod include nylon, polyurethane, polyvinyl chloride, and polypropylene. The support rod has a certain elasticity as the preferred solution. Suitable sizes include an outer diameter of the support rod between 5mm-10mm, and the length of the support rod is defined according to the corresponding pilot balloon length. Usually, the balloon support tube is 8mm-15mm longer than the peripheral pilot balloon.

[0008] The pilot balloon is sealed and combined with the outer periphery of the support rod. The combination method includes sealing and combining the front and rear end openings of the pilot balloon with the outer periphery of the support rod, or enclosing the head of the support rod in the inner cavity of the pilot balloon and sealing and combining the tail of the pilot balloon with the outer periphery of the support rod.

[0009] The sealing device is an interface for injecting liquid or gas into the pilot balloon, and can automatically close the injection port after the injection is completed. The sealing device is tightly combined with the tail of the support rod and seals the tail end of the diversion cavity.

[0010] The specific structure and material of the sealing device are not limited. For example, the sealing device is made of medical polymer elastic materials such as natural latex and silicone rubber to prepare an elastic sealing cover that can quickly restore the seal after puncture. The elastic sealing cover is tightly combined with the tail of the support rod, and can seal the tail end of the diversion cavity. For example, the elastic sealing cover is pierced by the needle of the pusher, and liquid or gas is injected into the inner cavity of the pilot balloon through the diversion cavity and the diversion hole to expand the balloon. After the pusher needle is pulled out of the sealing device, the sealing device can automatically close the puncture hole to prevent the injected liquid or gas from overflowing.

[0011] In one embodiment, the sealing device uses a one-way push-in joint, which is sealed with the tail of the support rod and seals the diversion cavity. For example, the sealing device includes a self-locking spring joint, a one-way valve, etc., which can play an equivalent sealing role as the elastic sealing cover.

[0012] In order to facilitate the smooth advancement of the advanced navigation balloon in the intestine after it is filled, the overall shape of the advanced navigation balloon adopts a tapered balloon structure or an umbrella-shaped balloon structure with a small head and a large tail. After filling, it presents a mushroom shape, a pear shape, or a bullet shape.

[0013] Furthermore, the outer surface of the advanced navigation balloon is also provided with a super-slip coating, which can reduce the friction between the advanced navigation balloon and the inner wall of the intestine and increase the compliance of the endoscope when it is inserted into the intestine. For example, hydrophilic polymer materials such as polyvinyl pyrrolidone (PVP), polyacrylamide (PAM), polyethylene glycol (PEG), polyvinyl alcohol (PVA), natural polysaccharides and derivatives are used as coatings to form a stable hydrophilic cross-linked coating on the outer surface of the advanced navigation balloon. The hydration layer formed by the non-ionic (hydroxyl or amino) or ionic (carboxyl or sulfonic acid) hydrophilic groups contained in the molecules absorbs water to give the outer surface of the advanced navigation balloon hydrophilicity and super-lubricity.

[0014] Suitable sizes of the advanced navigation balloon include an initial outer diameter of 6mm-15mm (calculated at the largest point) and an overall length of 30mm-60mm; the maximum outer diameter of the pilot balloon is not less than 50mm, and the maximum outer diameter refers to the maximum value of the cross-section of the balloon after it is filled and expanded.

[0015] The peripheral blocking balloon comprises an annular blocking balloon, a capillary tube, an elastic collar and a closed joint. The annular occluding capsule is a thin film cavity with an annular structure made of elastic medical polymer materials. The thin film cavity can be expanded by water or air, and folded back after the water or air is extracted. The annular occluding capsule is similar to a life buoy or donut structure. The appropriate size includes an initial outer diameter of 10mm-15mm (calculated at the maximum point) and an overall length of 10mm-30mm; the maximum outer diameter of the annular occluding capsule is not less than 50mm, and the maximum outer diameter refers to the maximum value of the cross-section of the annular occluding capsule after the balloon is filled and expanded.

[0016] The elastic ring is set in the inner ring of the annular occluding capsule and is tightly combined with the inner ring of the annular occluding capsule. The elastic ring is made of elastic polymer materials such as natural latex or silicone rubber, and has excellent elasticity and surface adsorption properties. The elastic ring is inserted into the outer periphery of the endoscope from the endoscope lens end and can be tightly combined with the outer periphery of the endoscope. When the endoscope is advanced or withdrawn in the intestine, the elastic ring will not slip. According to the different peripheral sizes and surface resistances of the adapted endoscope, the elastic ring is set to a variety of different models and specifications. Suitable sizes include an inner diameter of the elastic ring of 8mm-10mm and a width of 10mm-30mm, so that the elastic ring will not slip on the outer periphery of the endoscope during the process of advancing or withdrawing the endoscope.

[0017] In one embodiment, the elastic collar and the annular blocking bag are integrally formed, and the elastic collar is arranged on the inner ring of the annular blocking bag.

[0018] The capillary is a flexible small tube used to inject water / gas into the inner cavity of the annular occluding capsule. The outer wall of the head end of the capillary is sealed with the inside of the elastic ring, and the inner cavity of the capillary is connected with the inner cavity of the annular occluding capsule. The capillary is extruded and molded using polymer materials such as medical nylon, polyurethane, and polyvinyl chloride. Suitable sizes include the outer diameter of the capillary being 1.0mm-2.5mm and the length being 20mm-50mm.

[0019] The closed joint is sealed with the tail of the capillary tube, and the water / gas injection channel of the closed joint is connected with the inner cavity of the capillary tube. After the water / gas is injected into the inner cavity of the annular plugging bag through the closed joint and the capillary tube, the closed joint closes automatically to prevent the injected liquid or gas from overflowing.

[0020] The closed joint adopts a one-way spring interface, a one-way valve or an elastic sealing plug that can quickly restore the seal after penetration. Preferably, the closed joint adopts a silicone sealing plug, and the inner cavity of the annular sealing bag is injected with water / air using a pusher needle. After the pusher needle is removed, the puncture hole closes automatically.

[0021] After the endoscopic examination or surgery is completed, in order to facilitate the rapid withdrawal of the endoscope from the patient's intestine. In one embodiment, the capillary is extended to the periphery of the anus, and the doctor opens the closed joint in vitro to extract the liquid or gas in the inner cavity of the annular blocking sac, so that the annular blocking sac retracts to the initial state. Specifically, the length of the capillary is 50mm-100mm longer than the length of the endoscope entering the intestine. For example, the capillary is set to a length of 1400mm-1600mm, the inner cavity of the capillary is connected to the inner cavity of the annular blocking sac, and the tail end of the capillary is connected to the closed joint. During endoscopic examination or endoscopic surgery, the slender body of the capillary follows the annular blocking sac into the intestine, and the rear end of the capillary and the closed joint at the tail end are always exposed outside the anus. After the examination or surgery is completed, the gas or liquid in the inner cavity of the annular blocking sac is guided out with the shearable closed joint or by using a pusher, the annular blocking sac quickly retracts, and the endoscope withdraws from the intestine.

[0022] Furthermore, in order to prevent the front navigation balloon from sliding into the intestine by itself under the pressure of gas injection, a limiting device is provided between the front navigation balloon and the peripheral blocking balloon, and the limiting device is a tensile flexible wire. Specifically, for example: a limiting wire is provided between the tail of the front navigation balloon and the elastic ring of the peripheral blocking balloon to limit the distance between the front navigation balloon and the peripheral blocking balloon. The limiting wire is made of polymer materials with high tensile strength including nylon, polypropylene, nylon, etc. Appropriate technical requirements include that the tensile strength of the limiting wire is not less than 10N and the length of the limiting wire is 150mm-300mm.

[0023] The injector is an auxiliary device for injecting or extracting water / gas into the inner cavity of the front navigation balloon or the peripheral blocking balloon. The injector includes an injector head, an injector cavity and an injector handle, wherein: The structure of the push-in head matches the sealing device of the leading navigation balloon or the closing joint of the peripheral blocking balloon, and can be quickly combined. The matching and combination methods include: for example, when the sealing device or the closing joint adopts an elastic sealing body, the push-in head is set as a puncture needle structure, and the puncture method is used for quick combination to inject liquid or gas into the inner cavity of the pilot balloon or the annular blocking balloon; after the push-in head is separated from the sealing device or the closing joint, the elastic sealing body automatically closes the puncture hole to prevent the injected liquid or gas from escaping. For another example, the sealing device or the closing joint adopts a spring self-locking joint, and the push-in head is set as a nipple protrusion structure that matches and combines with the injection port of the spring self-locking joint. After the liquid or gas is injected into the inner cavity of the pilot balloon or the annular blocking balloon, the push-in head is separated from the sealing device or the closing joint, and the spring self-locking joint automatically closes the infusion path.

[0024] The push injection chamber is a cylindrical tubular structure container for containing liquid or gas, and the internal capacity of the push injection chamber is 20ml-50ml.

[0025] The push handle is used to control the amount and speed of liquid or gas injection. The push handle is combined with the push cavity, the head of the push handle is provided with a sealing ring that is tightly combined with the inner wall of the push cavity, and the tail of the push handle is provided with a push rod for medical staff to perform infusion operations.

[0026] In an embodiment of clinical application, the injector is also used to push a distal navigation balloon into the rectum. After the injector is combined with the distal navigation balloon, the distal navigation balloon is pushed from the anus into the patient's rectum. After the distal navigation balloon is injected with water / air, the injector is separated from the distal navigation balloon and withdrawn from the anus.

[0027] It should be noted that the injector can also be used as an optional component of the present application, rather than a necessary component. In clinical practice, the injector can be a general syringe, a drug injector, etc., and it is appropriate to match the injector with the sealing device and the closed joint.

[0028] A method for establishing an endoscopic tunnel during colonoscopy or surgery, comprising: S1, combine the injector and the sealing device of the tip navigation balloon, and push the tip navigation balloon into the rectum through the anus; after injecting a proper amount of water or air into the tip navigation balloon, separate the injector from the tip navigation balloon.

[0029] For example, the injector draws an appropriate amount of normal saline or medical gas, such as 30ml-40ml, and injects it into the inner cavity of the pilot balloon until the pilot balloon is fully filled.

[0030] S2, insert the endoscope into the elastic ring of the peripheral occlusion balloon from the lens end, pull the elastic ring, and make the peripheral occlusion balloon firmly combined downstream of the curved part of the endoscope.

[0031] The curved part refers to the neck part downstream of the endoscope lens that can control the lens deflection. The peripheral occlusion balloon assembly is firmly placed 20mm-30mm downstream of the curved part of the endoscope, so as not to affect the deflection of the endoscope lens.

[0032] S3: Insert the lens end of the endoscope through the anus into the rectum. Under direct vision of the endoscope, further push the navigation balloon at the tip into the upper end of the rectum.

[0033] For example, under direct endoscopic vision, the tip of the navigation balloon is pushed to the S-shaped part of the rectum, or to the junction of the rectum and the sigmoid colon using the lens end.

[0034] S4, inject a proper amount of water or medical gas into the annular blocking balloon at the closed joint of the peripheral blocking balloon, so that the peripheral blocking balloon remains in the anal cavity.

[0035] For example, using an injector, 15ml-20ml of normal saline or medical gas is injected into the annular occluding bag until the annular occluding bag is fully filled.

[0036] S5, inject medical gas into the rectum through the gas injection channel of the endoscope, and the intestine between the tip navigation balloon and the peripheral blocking balloon is expanded by the medical gas to form an endoscopic diagnostic or surgical tunnel.

[0037] The intestinal wall between the front navigation balloon and the peripheral blocking balloon is expanded by the injected medical gas (such as carbon dioxide or nitrogen), and the intestinal mucosa and folds can be clearly viewed by the endoscope. Under the blocking effect of the balloons at both ends of the upstream and downstream, a stable endoscopic diagnosis or surgical tunnel is formed, which can smoothly perform photo diagnosis or endoscopic surgery in the rectum (such as polypectomy, etc.).

[0038] S6, after completing the rectal examination, use the endoscope to continue pushing the tip navigation balloon forward, and keep a distance of 150mm-200mm between the tip navigation balloon and the peripheral occlusion balloon to form endoscopic diagnosis or surgical tunnels in various parts of the intestine.

[0039] For example, the front navigation balloon and the peripheral blocking balloon can reach the sigmoid colon, descending colon, transverse colon, ascending colon, cecum, and finally the ileum in sequence. Under the blocking effect of the front navigation balloon and the peripheral blocking balloon, air is injected into each part to form a stable endoscopic diagnosis or surgical tunnel.

[0040] S7. When the tip navigation balloon reaches the ileum, use endoscopic surgical instruments to release the liquid or medical gas in the pilot balloon to retract the tip navigation balloon to its initial state, and use an endoscopic grabber or surgical forceps to clamp the tip navigation balloon and slowly withdraw the tip navigation balloon and the endoscopic lens end from the intestine.

[0041] The clinical uses of the present application include assisting in the advancement of the scope during colonoscopy or endoscopic surgery, and effectively controlling the leakage of injected gas, establishing an endoscopic diagnosis or surgical tunnel between the distal navigation balloon and the peripheral occlusion balloon, and improving the local diagnostic field of view or endoscopic surgical field in the intestine.

[0042] The beneficial effect of the present application is that during intestinal endoscopic diagnosis or endoscopic surgery, the front navigation balloon and the peripheral blocking balloon work together, using the compliance of the front navigation balloon to open the intestine, and slowly slide under the drive of the rear air pressure, which is conducive to the doctor to insert the scope more smoothly and avoid the difficulty of inserting the scope or the occurrence of intestinal perforation. At the same time, the front navigation balloon and the peripheral blocking balloon are combined and blocked in the front and back of the intestine, and the intestine is pushed forward and gas is injected in sections to form a stable endoscopic diagnosis or surgical tunnel in different areas of the intestine, which not only improves the efficiency of endoscopic diagnosis or endoscopic surgery, but also avoids the adverse consequences such as abdominal distension and abdominal pain caused by a large amount of air intake, and reduces the risk of endoscopic diagnosis or surgery. The present application is simple to operate, safe and reliable, and is worthy of clinical promotion and use. BRIEF DESCRIPTION OF THE DRAWINGS

[0043] Figure 1 This is a schematic diagram of the overall structure of an embodiment of the present application. Figure 2 This is a schematic diagram of a clinical application of an embodiment of the present application. As shown in the figure: the front navigation balloon 10, the pilot balloon 11, the support rod 12, the sealing device 13, the diversion hole 14, the injector 20, the injector head 21, the injector cavity 22, the injector handle 23, the peripheral blocking balloon 30, the anal blocking balloon 31, the capillary 32, the elastic ring 33, the closing joint 34, the head end of the endoscope 35, the rectum 36, and the anus 37 DETAILED DESCRIPTION

[0044] The present application is described in detail below with reference to the accompanying drawings and embodiments.

[0045] Example 1: Preparation of an advanced navigation balloon 10 and a peripheral occlusion balloon 30 1. Preparation of the Advanced Navigation Balloon 10 like Figure 1 As shown in the structure, the various components of this application are prepared.

[0046] 1.1 Preparation of pilot balloon 11 1.1.1 Prepare the plastic extrusion die for the pilot balloon 11 tube embryo, select polyurethane material, use precision extrusion equipment for extrusion molding, cut into 30mm length tubes, as the pilot balloon 11 tube embryo, and set aside.

[0047] 1.1.2 Prepare the blow molding mold for the pilot balloon 11 tube embryo, and the pilot balloon 11 tube embryo is subjected to secondary molding under low temperature and low pressure conditions, and the molding shape is mushroom-shaped. The specific method is to put the pilot balloon 11 tube embryo into the blow molding mold, pass nitrogen, maintain the low pressure at 2.6MPa, and gradually increase the mold temperature to 110°C. The stretching speed of the clamps at both ends is 70mm / s, and the stretching distance is 50mm to produce a thinner cone and neck wall thickness. Then, heat and hold the pressure to complete the crystallization orientation of the molded balloon. Cool and demold, take out the pilot balloon 11, cut off the excess tube embryos used for pulling at both ends, so that the wall thickness of the pilot balloon 11 is 0.1mm, the overall length is 42mm (the neck length of both ends of the balloon is 6mm each), the inner diameter of the neck is 5mm, and the maximum diameter is 80mm (calculated by the maximum expansion value), and it is ready for use.

[0048] 1.2 Preparation of support rod 12 1.2.1 Prepare a tube extrusion die for the support rod 12. The material is polyurethane. The outer diameter of the support rod 12 is 4.0 mm and the inner diameter is 2.5 mm.

[0049] 1.2.2 It is processed by high-precision plastic extrusion equipment, and after cooling and shaping, it is cut into support rods 12 with a length of 50 mm.

[0050] 1.2.3 Use a pipe punching device to open a 2.0 mm guide hole 14 on the outer periphery of the support rod 12.

[0051] 1.2.4 Use the hot-melt sealing processing equipment for the pipe head to hot-melt the head end of the support rod 12 into an R angle, and completely close the injection channel of the support rod 12 for standby use.

[0052] 1.3 The sealing device 13 adopts a spring one-way valve with a Luer interface, and the outer diameter of the raised part connected to the support rod 12 is 2.4mm. The sealing device 13 is sealed and combined with the tail end of the support rod 12 by internal connection using medical glue.

[0053] 1.4 Insert the pilot balloon 11 prepared in step 1 from the head end of the support rod 12, and use high-frequency heat sealing equipment to seal the pilot balloon 11 on the outer periphery of the support rod 12. The tail end of the support rod 12 and the sealing device 13 should expose the pilot balloon 11.

[0054] 1.5 Check the tightness of the combined or bonded parts, and put them into storage if they meet the requirements.

[0055] 2. Preparation of Peripheral Occlusion Balloon 30 2.1 Preparation of annular plugging capsule 31: Referring to the process flow in 1.1, annular plugging capsule 31 is prepared using silicone rubber material. The annular plugging capsule 31 is required to be in the shape of a donut, with an inner ring diameter of 11 mm, an outer ring diameter of 80 mm (calculated by the maximum expansion value), and a height of 25 mm. A hole-opening device is used to open a 2 mm-4 mm diversion hole 14 in the inner ring of the annular plugging capsule 31 for later use.

[0056] 2.2 Prepare a double-lumen catheter extrusion die for the elastic collar 33, with an inner diameter of 9.0 mm and an outer diameter of 11 mm, and a 0.8 mm diversion cavity on the tube wall. The silicone rubber catheter extrusion process is used to produce the silicone rubber tube, and after extruding the silicone rubber tube, it is cut into elastic collars 33 of 22 mm in length. Then, a punching device is used to open a 0.6 mm diversion hole 14 on the outer wall of the diversion cavity at the center point of the length of the elastic collar 33.

[0057] 2.3 Prepare the extrusion die of the capillary 32. The material is polyurethane. The outer diameter of the capillary 32 is 0.78 mm and the inner diameter is 0.5 mm. Use high-precision plastic extrusion equipment for processing. After cooling and shaping, cut into capillaries 32 with a length of 35 mm. Set aside.

[0058] 2.4 Bonding of components 2.4.1 Use medical glue to bond the head end of the capillary 32 to the guide cavity at the upper end of the elastic ring 33, and use medical glue to close the guide cavity at the lower end of the elastic ring 33; the tail end of the capillary 32 is tightly bonded to the closed joint 34, and the closed joint 34 uses a spring one-way valve.

[0059] 2.4.2 Insert the inner ring of the annular occluding capsule 31 into the outer periphery of the elastic collar 33, and align the diversion hole 14 of the annular occluding capsule 31 with the diversion hole 14 of the elastic collar 33. Use medical glue to seal the inner ring of the annular occluding capsule 31 and the elastic collar 33.

[0060] 2.4.3 Check the tightness of the combined or bonded parts and put them into storage if they meet the requirements.

[0061] The push injector 20 can directly adopt the existing push injector 20 or push injector, which belongs to the conventional production process and the preparation process is not described in detail.

[0062] Example 2: Clinical application example of the present application in endoscopic examination like Figure 2 As shown, the product prepared in Example 1 of the present application is used to perform intestinal endoscopy. The specific application steps are as follows: 1. Use a 50ml medical syringe as the injector 20, the injector head 21 of the medical syringe is a Luer interface, and draw 40ml of sterile saline. The spring one-way valve Luer connector at the bottom of the front navigation balloon 10 prepared in Example 1 is combined and connected with the injector head 21 of the injector 20.

[0063] 2. Insert the elastic collar 33 of the peripheral blocking balloon 30 from the endoscope head and pull it to 20mm-30mm downstream of the endoscope bending part.

[0064] 3. Apply a proper amount of glycerin as a lubricant on the periphery of the patient's anus 37, gently push the tip navigation balloon 10 into the patient's rectum 36, press the injection handle 23, and inject 30 ml of normal saline into the pilot balloon 11, so that the pilot balloon 11 expands and anchors in the rectum 36.

[0065] 4. Insert the endoscope head into the rectum 36 through the anus 37 until the peripheral blocking balloon 30 enters the anus 37 , keeping the tail end of the capillary tube 32 and the closure connector 34 exposed outside the anus 37 .

[0066] 5. According to the method of step 1 and step 3, the pusher 20 is connected to the closed joint 34, and 20mm-30mm of normal saline is injected into the annular occluding sac 31 to expand the annular occluding sac 31.

[0067] 6. Inject carbon dioxide gas into the rectum 36 through the endoscopic gas injection passage to check the gas leakage status around the anus 37. If the amount of leaked gas is large, continue to push physiological saline into the annular blocking bag 31.

[0068] 7. Under the condition of direct endoscopy, the endoscope is used to continue to push the front navigation balloon 10 forward and anchor the front navigation balloon 10 at the junction of the rectum 36 and the sigmoid colon. At this time, a stable endoscopy diagnosis tunnel is formed between the front navigation balloon 10 and the peripheral blocking balloon 30, which is convenient for the doctor to directly view and take pictures of various parts inside the rectum 36 through endoscopy.

[0069] 8. After the examination of the rectum 36 is completed, continue to push the distal navigation balloon 10 forward according to the method in step 7, establish tunnels in each part in turn, and perform endoscopic direct vision and photography of the sigmoid colon, descending colon, transverse colon, ascending colon and cecum in turn.

[0070] 9. After the inspection is completed, insert surgical forceps into the instrument channel of the endoscope and use the surgical forceps to cut the pilot balloon 11 to leak the liquid in the pilot balloon 11. Use surgical forceps to clamp the leading navigation balloon 10 and withdraw it from the body together with the endoscope. Remove the peripheral blocking balloon 30 of the endoscope, and the operation is completed.

[0071] During intestinal endoscopic surgery, according to the endoscopic diagnosis results, the lesion site can be located to establish an endoscopic surgical tunnel and perform endoscopic polypectomy and other surgeries. For specific methods, please refer to steps 1 to 9, which will not be described in detail.

[0072] The above drawings and embodiments are only used to illustrate the technical solution of the present application and are not intended to limit it. Although the present application has been described in detail with reference to the preferred embodiments, those skilled in the art should understand that the technical solution of the present application can be modified or replaced by equivalents without departing from the purpose and scope of the technical solution of the present application, which should be included in the scope of the claims of the present application and do not constitute any limitation on the scope of protection of the present application.

Claims

1. A device for establishing an endoscopic tunnel during colonoscopy or surgery, comprising a front navigation balloon 10, a peripheral blocking balloon 30 and an injector 20; the front navigation balloon 10 is mainly composed of a pilot balloon 11, a support rod 12 and a sealing device 13, and the peripheral blocking balloon 30 includes an annular blocking balloon 31, a capillary tube 32, an elastic ring 33 and a closed joint 34; wherein, The support rod 12 is provided with a flow diversion channel inside, and at least one flow diversion hole 14 for connecting the flow diversion channel with the inner cavity of the pilot balloon 11 should be provided on the support rod 12. The pilot balloon 11 is sealed and combined with the outer periphery of the support rod 12, and the sealing device 13 is sealed and combined with the tail of the support rod 12; the annular blocking capsule 31 is a thin film cavity with an annular structure made of elastic medical polymer material, and the elastic collar 33 is arranged on the inner ring of the annular blocking capsule 31 and is sealed and combined with the inner ring of the annular blocking capsule 31; the outer wall of the head end of the capillary 32 is sealed and combined with the inner wall of the elastic collar 33, and the inner cavity of the capillary 32 is sealed and combined with the inner cavity of the annular blocking capsule 31 The closure joint 34 is sealed with the tail of the capillary 32, and the water / air channel of the closure joint 34 is connected with the inner cavity of the capillary 32; its characteristics are: during intestinal endoscopic diagnosis or endoscopic surgery, the tip navigation balloon 10 and the peripheral blocking balloon 30 cooperate, and the compliance of the tip navigation balloon 10 is used to open the intestine, and it slides slowly under the drive of the rear air pressure, which is conducive to smoother insertion of the doctor; at the same time, the tip navigation balloon 10 and the peripheral blocking balloon 30 are combined and blocked in the front and back of the intestine, and are pushed and injected in sections in the intestine to form a stable endoscopic diagnosis or surgical tunnel in different areas of the intestine.

2. The device for establishing an endoscopic tunnel during colonoscopy or surgery according to claim 1, characterized in that: The pilot balloon 11 is a hollow film cavity made of elastic medical polymer material. The film cavity can be expanded by filling water or air, and can be folded and restored after the water or air is extracted.

3. The device for establishing an endoscopic tunnel during colonoscopy or surgery according to claim 1, characterized in that: The overall shape of the front navigation balloon 10 adopts a tapered balloon structure or an umbrella-shaped balloon structure with a small head and a large tail. After being filled, it presents a mushroom shape, a pear shape, or a bullet shape.

4. The device for establishing an endoscopic tunnel during colonoscopy or surgery according to claim 1, characterized in that: The outer surface of the tip navigation balloon 10 is also provided with a super-slip coating, which can reduce the friction between the tip navigation balloon 10 and the inner wall of the intestine and increase the compliance of the endoscope when it is inserted into the intestine.

5. The device for establishing an endoscopic tunnel during colonoscopy or surgery according to claim 1, characterized in that: Suitable sizes of the advanced navigation balloon 10 include an initial outer diameter of the advanced navigation balloon 10 of 6 mm to 15 mm, and a maximum outer diameter of the pilot balloon 11 of not less than 50 mm.

6. The device for establishing an endoscopic tunnel during colonoscopy or surgery according to claim 1, characterized in that: The elastic collar 33 is integrally formed with the annular blocking bag 31 , and the elastic collar 33 is arranged on the inner circle of the annular blocking bag 31 .

7. The device for establishing an endoscopic tunnel during colonoscopy or surgery according to claim 1, characterized in that: A limiting device is also provided between the front navigation balloon 10 and the peripheral blocking balloon 30 , and the limiting device is a flexible wire.

8. The device for establishing an endoscopic tunnel during colonoscopy or surgery according to claim 1, characterized in that: The pusher 20 is also used to push the distal navigation balloon 10 into the rectum 36. After the pusher 20 is combined with the distal navigation balloon 10, the distal navigation balloon 10 is pushed into the patient's rectum 36 from the anus 37. After the distal navigation balloon 10 is injected with water / air, the pusher 20 is separated from the distal navigation balloon 10, and the pusher 20 withdraws from the anus 37.

9. A method for establishing an endoscopic tunnel during colonoscopy or surgery according to claim 1, comprising: S1, the pusher 20 is combined with the sealing device 13 of the front navigation balloon 10, and the front navigation balloon 10 is pushed into the rectum 36 through the anus 37; after injecting a proper amount of water or gas into the front navigation balloon 10, the pusher 20 is separated from the front navigation balloon 10; S2, insert the endoscope from the lens end into the elastic collar 33 of the peripheral blocking balloon 30, pull the elastic collar 33, and make the peripheral blocking balloon 30 firmly assembled at the downstream of the curved part of the endoscope; S3, insert the lens end of the endoscope into the rectum 36 through the anus 37, and further push the leading end navigation balloon 10 into the upper end of the rectum 36 under direct vision of the endoscope; S4, injecting a proper amount of water or medical gas into the annular blocking balloon 31 at the closed joint 34 of the peripheral blocking balloon 30, so that the peripheral blocking balloon 30 is retained in the inner cavity of the anus 37; S5, injecting medical gas into the rectum 36 through the gas injection channel of the endoscope, the intestine between the front navigation balloon 10 and the peripheral blocking balloon 30 is expanded by the medical gas, forming an endoscope diagnosis or surgical tunnel; S6, after completing the inspection of the rectum 36, the endoscope end is used to continue to push the front navigation balloon 10 forward, and the front navigation balloon 10 and the peripheral blocking balloon 30 are kept at a distance of 150mm-200mm, so as to form an endoscopic diagnosis or surgical tunnel in various parts of the intestine; S7, when the tip navigation balloon 10 reaches the ileum, an endoscopic surgical instrument is used to release the liquid or medical gas in the guide balloon 11 to retract the tip navigation balloon 10 to its initial state, and an endoscopic grabber or surgical forceps is used to clamp the tip navigation balloon 10 to slowly withdraw the tip navigation balloon 10 together with the endoscopic lens end from the intestine.

10. A device and method for establishing an endoscopic tunnel during colonoscopy or surgery, the clinical uses of which include: It is used for assisting the insertion of the scope during colonoscopy or endoscopic surgery, and effectively controlling the leakage of the injected gas, establishing an endoscopic diagnosis or surgery tunnel between the distal navigation balloon 10 and the peripheral blocking balloon 30, and improving the local diagnostic field of the intestine or the endoscopic surgery field.

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