Device for establishing endoscopic tunnel in enteroscopy or operation

Abstract

The utility model relates to a device for establishing an endoscopic tunnel in enteroscopy or operation, which is used for assisting in entering the enteroscopy or the endoscopic operation, effectively controlling the leakage of injected gas, establishing an endoscopic diagnosis or operation tunnel between a tip navigation balloon and a peripheral plugging balloon, and improving the local diagnosis visual field or the endoscopic operation field in the intestinal tract. 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 application relates to a device for establishing an endoscope tunnel in enteroscopy or surgery, belonging to the field of disposable sterile medical devices used in hospitals. BACKGROUND

[0002] Colorectal cancer (CRC) is a common malignant tumor, and its incidence and mortality are increasing year by year. CRC has become one of the malignant tumors with high incidence in the world, and its incidence and mortality rank the third and second in the world, respectively. Regular screening and early treatment are the key to improving the prognosis and economic burden of CRC patients. Colonoscopy is the gold standard for CRC screening. CRC patients without lymph node metastasis are treated by endoscopic resection according to the size and location of the tumor. Adenomatous polyps or polyps greater than or equal to 5 mm in diameter (whether or not they are adenomatous) are recommended for resection.

[0003] Due to the longitudinal and horizontal folds and grooves of the mucosa of the human intestinal wall, a certain amount of nitrogen or carbon dioxide gas must be injected during enteroscopy or endoscopic resection surgery to expand the intestinal cavity and the contracted mucosal folds, so that the surgeon has sufficient surgical field space and can clearly observe the colon wall or perform surgery. However, in existing clinical practice, when gas is injected into the intestine, part of the gas quickly flows upward to the small intestine and stomach, and another part quickly flows downward along the periphery of the endoscope to the anus. Therefore, during enteroscopy or endoscopic resection surgery, gas must be continuously injected into the intestine. This not only seriously affects the progress of enteroscopy or endoscopic surgery and increases the labor intensity of the surgeon, but also easily induces complications of enteroscopy or endoscopic surgery, including severe abdominal pain, vomiting, etc. If too much gas is delivered, the intestine is excessively stretched and expanded, the intestinal wall is thinned, and the colonoscopy is improperly inserted, which can cause intestinal perforation. Therefore, industry professionals have proposed that "controlling the amount of gas is to control the large intestine", which is not without reason. At the same time, due to the nine bends and eighteen turns of the human colon, enteroscopy is inserted from the anus, through the rectum, sigmoid colon, descending colon, splenic flexure of the colon, transverse colon, hepatic flexure of the colon, cecum, and finally to the ileocecal junction or the end of the small intestine before exiting. The surgeon needs years of practice to master the insertion technique, and the insertion process is not only time-consuming and labor-intensive, but also increases the patient's pain and even causes intestinal perforation, leading to serious medical consequences.

[0004] In order to solve the problems of difficult insertion and gas control during enteroscopy or surgery, and to help the surgeon smoothly insert the endoscope and establish a good enteroscopy diagnosis or surgical field of view, the application proposes a device for establishing an endoscope tunnel in enteroscopy or surgery to overcome the shortcomings of the prior art. SUMMARY

[0005] A device for establishing an endoscopic tunnel in enteroscopy or surgery, comprising a leading navigation balloon, a peripheral blocking balloon and a pusher.

[0006] The leading navigation balloon is mainly composed of a leading balloon, a support rod and a sealing device, wherein:

[0007] The leading balloon is a hollow thin film cavity made of elastic medical polymer material. The thin film cavity can be inflated by water or gas and folded back after the water or gas is extracted. The polymer material used includes nylon, polyurethane, latex, silicone and other non-toxic medical polymer composite materials.

[0008] The support rod is made of medical polymer material in the form of a tube. The inside of the support rod is provided with a flow guide channel. At least one flow guide hole is provided on the support rod for the flow guide channel to communicate with the inner cavity of the leading balloon. The polymer material used for the support rod includes nylon, polyurethane, polyvinyl chloride and polypropylene. The support rod has a certain elasticity, which is the preferred scheme. Suitable dimensions include an outer diameter of the support rod of 5-10 mm, and the length of the support rod is defined according to the length of the corresponding leading balloon. Generally, the length of the balloon support tube is 8-15 mm longer than the peripheral leading balloon.

[0009] The leading balloon is sealed and combined with the outer periphery of the support rod. The combination method includes sealing and combining the front and rear openings of the leading balloon with the outer periphery of the support rod, or wrapping the head of the support rod in the inner cavity of the leading balloon and sealing and combining the tail of the leading balloon with the outer periphery of the support rod.

[0010] The sealing device is an interface for injecting liquid or gas into the leading balloon. After the injection is completed, the injection port can be automatically closed. The sealing device is sealed and combined with the tail of the support rod, and the tail end of the flow guide channel is sealed.

[0011] 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 cap that can quickly restore sealing after puncture. The elastic sealing cap is sealed and combined with the tail of the support rod, and can seal and block the tail end of the flow guide channel. For example, the pusher needle pierces the elastic sealing cap, injects liquid or gas into the inner cavity of the leading balloon through the flow guide channel and the flow guide hole, and expands 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.

[0012] In one embodiment, the sealing device uses a one-way push injection connector, which is sealed and combined with the tail of the support rod and seals the flow guide channel. For example, the sealing device uses a self-locking spring connector, a one-way valve and the like, all of which can play the equivalent sealing role of the elastic sealing cap.

[0013] In order to facilitate the smooth pushing of the front navigation balloon in the intestinal tract after the balloon is filled, the overall shape of the front navigation balloon adopts a tapered balloon structure with a small head and a large tail or an umbrella-shaped balloon structure, and after being filled, it presents a mushroom shape, or a brest shape, or a bullet shape.

[0014] Further, the outer surface of the front navigation balloon is also provided with a super-slippery coating, which can reduce the friction between the front navigation balloon and the intestinal wall and increase the compliance of the endoscope in the intestinal tract. For example, polyvinylpyrrolidone (PVP), polyacrylamide (PAM), polyethylene glycol (PEG), polyvinyl alcohol (PVA), natural polysaccharides and derivatives, etc. are used as the coating, and a stable hydrophilic cross-linked coating film is formed on the outer surface of the front navigation balloon. The hydration layer formed by the absorption of water by the non-ionic (hydroxyl or amine groups, etc.) or ionic (carboxyl or sulfonic acid groups, etc.) hydrophilic groups in the molecules endows the outer surface of the front navigation balloon with hydrophilicity and super-lubricity.

[0015] The suitable size of the front navigation balloon includes that the initial outer diameter of the front navigation balloon is between 6 mm and 15 mm (calculated at the maximum), and the overall length is between 30 mm and 60 mm; the maximum outer diameter of the guide balloon is not less than 50 mm, and the maximum outer diameter refers to the maximum value of the cross section of the balloon after being filled and inflated.

[0016] The outer peripheral blocking balloon includes a ring-shaped blocking balloon, a capillary tube, an elastic sleeve ring and a closed joint.

[0017] The ring-shaped blocking balloon is a thin film cavity with a ring structure made of elastic medical polymer material. The thin film cavity can be inflated by water or gas and can be folded and restored after the water or gas is extracted. The ring-shaped blocking balloon is similar to a life buoy or a doughnut structure, and the suitable size includes that the initial outer diameter of the ring-shaped blocking balloon is between 10 mm and 15 mm (calculated at the maximum), and the overall length is between 10 mm and 30 mm; the maximum outer diameter of the ring-shaped blocking balloon is not less than 50 mm, and the maximum outer diameter refers to the maximum value of the cross section of the ring-shaped blocking balloon after being filled and inflated.

[0018] The elastic sleeve ring is arranged in the inner circle of the ring-shaped blocking balloon and is in close combination with the inner circle of the ring-shaped blocking balloon. The elastic sleeve ring is made of natural latex or silicone rubber and has excellent stretching performance and surface adsorption performance. The elastic sleeve ring is sleeved into the outer periphery of the endoscope from the lens end of the endoscope, and can be closely combined with the outer periphery of the endoscope. When the endoscope is pushed or withdrawn in the intestinal tract, the elastic sleeve ring will not slip. According to the different sizes and surface resistances of the adapted endoscope outer periphery, the elastic sleeve ring is provided in multiple different models and specifications, and the suitable size includes that the inner diameter of the elastic sleeve ring is 8 mm to 10 mm, and the width is 10 mm to 30 mm, so that the elastic sleeve ring will not slip in the outer periphery of the endoscope during the insertion or withdrawal process.

[0019] In an embodiment, the elastic collar is integrally formed with the annular occlusion balloon, and the elastic collar is arranged at the inner ring of the annular occlusion balloon.

[0020] The capillary tube is a flexible small tube for injecting water / gas into the inner cavity of the annular occlusion balloon, the outer wall of the head end of the capillary tube is in close combination with the inside of the elastic collar, and the inner cavity of the capillary tube is in communication with the inner cavity of the annular occlusion balloon. The capillary tube is extruded from medical nylon, polyurethane, polyvinyl chloride and other high molecular materials. Suitable sizes include that the outer diameter of the capillary tube is 1.0mm-2.5mm, and the length is 20mm-50mm.

[0021] The closed connector is in close combination with the tail of the capillary tube, and the water / gas injection channel of the closed connector is in communication with the inner cavity of the capillary tube. After the inner cavity of the annular occlusion balloon is injected with water / gas through the closed connector and the capillary tube, the closed connector is automatically closed to prevent the injected liquid or gas from overflowing.

[0022] The closed connector adopts a one-way spring interface, a one-way valve or an elastic sealing plug that can be quickly restored to sealing after penetration. Preferably, the closed connector adopts a silica gel sealing plug, and a syringe needle is used to inject water / gas into the inner cavity of the annular occlusion balloon. After the syringe needle is removed, the puncture hole is automatically closed.

[0023] After the endoscopy or surgery is completed, in order to facilitate the rapid exit of the endoscope in the intestinal tract of the patient. In an embodiment, the capillary tube is extended to the periphery of the anus, the doctor opens the closed connector outside the body, and the liquid or gas in the inner cavity of the annular occlusion balloon is extracted, so that the annular occlusion balloon is retracted to the initial state. The specific way is that the length of the capillary tube is 50mm-100mm longer than the length of the endoscope entering the intestinal tract, for example, the capillary tube is arranged to have a length of 1400mm-1600mm, the inner cavity of the capillary tube is in communication with the inner cavity of the annular occlusion balloon, and the tail end of the capillary tube is connected with the closed connector. During endoscopy or endoscopic surgery, the slender body of the capillary tube enters the intestinal tract along with the annular occlusion balloon, and the tail end of the capillary tube and the closed connector are always exposed outside the periphery of the anus. After the examination or surgery is completed, the gas or liquid in the inner cavity of the annular occlusion balloon is guided out with the cuttable closed connector or a syringe, and the annular occlusion balloon is quickly retracted, and the endoscope exits the intestinal tract.

[0024] Further, in order to prevent the front navigation balloon from sliding into the intestinal tract under the gas injection pressure, a limiting device is arranged between the front navigation balloon and the peripheral occlusion balloon, and the limiting device is a tensile flexible wire. Specifically, for example, a limiting wire is arranged between the tail of the front navigation balloon and the elastic collar of the peripheral occlusion balloon to limit the distance between the front navigation balloon and the peripheral occlusion balloon. The limiting wire is made of high molecular materials with high tensile strength, including nylon, polypropylene, nylon, etc. Suitable 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.

[0025] The aforementioned injector is an auxiliary device used to inject or extract water / gas into the cavity of a tip navigation balloon or a peripheral occlusion balloon. The injector includes an injector head, an injector cavity, and an injector handle, wherein:

[0026] The injector head's structure matches the sealing device of the pilot navigation balloon or the sealing connector of the peripheral occlusion balloon, allowing for quick assembly. Matching and assembly methods include: for example, when the sealing device or sealing connector uses an elastic sealing body, the injector head is configured as a puncture needle structure, allowing for quick assembly via puncture to inject liquid or gas into the inner cavity of the pilot balloon or annular occlusion balloon; after the injector head separates from the sealing device or sealing connector, the elastic sealing body automatically closes the puncture hole to prevent the injected liquid or gas from escaping. Another example is when the sealing device or sealing connector uses a spring-locking connector, and the injector head is configured as a nipple-shaped protrusion structure that matches the injection port of the spring-locking connector; after the liquid or gas is injected into the inner cavity of the pilot balloon or annular occlusion balloon, the injector head separates from the sealing device or sealing connector, and the spring-locking connector automatically closes the infusion pathway.

[0027] A push chamber is a cylindrical tubular container used to hold liquids or gases, with an internal capacity of 20ml-50ml.

[0028] The injection handle is used to control the injection volume and rate of liquid or gas. The injection handle is combined with the injection chamber; the head of the injection handle has a sealing ring that tightly seals against the inner wall of the injection chamber, and the tail of the injection handle has a push rod for medical personnel to operate the infusion.

[0029] In one clinical application embodiment, the injector is also used to push a tip navigation balloon into the rectum. After the injector and tip navigation balloon are combined, the tip navigation balloon is pushed from the anus into the patient's rectum. After water / air is injected into the tip navigation balloon, the injector separates from the tip navigation balloon, and the injector is withdrawn from the anus.

[0030] It should be noted that the syringe plunger can be an optional component of this application, rather than a mandatory one. In clinical practice, the syringe plunger can be a general-purpose syringe, drug plunger, etc., as long as the plunger can be matched and combined with the sealing device and closure connector.

[0031] Methods for creating endoscopic tunnels during colonoscopy or surgery include:

[0032] S1, combine the injector with the sealing device of the tip navigation balloon, and push the tip navigation balloon into the rectum through the anus; after injecting an appropriate amount of water or air into the tip navigation balloon, separate the injector from the tip navigation balloon.

[0033] For example, use an injector to draw an appropriate amount of saline or medical gas, such as 30ml-40ml, and inject it into the pilot balloon cavity until the pilot balloon is fully inflated.

[0034] S2, insert the endoscope into the elastic sleeve of the peripheral blocking balloon from the lens end, pull the elastic sleeve, and firmly combine the peripheral blocking balloon downstream of the bending part of the endoscope.

[0035] The bending part refers to the neck part downstream of the endoscope lens which can control the deflection of the lens. The peripheral blocking balloon is firmly combined 20-30 mm downstream of the bending part of the endoscope, which is appropriate to not affect the deflection of the endoscope lens end.

[0036] S3, insert the lens end of the endoscope into the rectum through the anus, and further push the leading navigation balloon into the upper end of the rectum under the direct vision of the endoscope.

[0037] For example, under the direct vision of the endoscope, the leading navigation balloon is pushed to the sigmoid part of the rectum or to the junction of the rectum and sigmoid colon by the lens end.

[0038] S4, inject an appropriate 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 is left in the anal cavity.

[0039] For example, use a syringe to inject 15-20 ml of normal saline or medical gas into the annular blocking balloon, which is appropriate to make the annular blocking balloon full and plump.

[0040] S5, inject medical gas into the rectum through the gas injection channel of the endoscope, and the intestinal tract between the leading navigation balloon and the peripheral blocking balloon is expanded by the medical gas to form a diagnostic or surgical tunnel of the endoscope.

[0041] The inner wall of the intestinal tract between the leading 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 seen by the endoscope. Under the blocking effect of the balloons at the upstream and downstream ends, a stable diagnostic or surgical tunnel of the endoscope is formed, which can smoothly perform photographic diagnosis or endoscopic surgery (such as polyp resection) at the rectal site.

[0042] S6, after completing the examination of the rectal site, continue to push the leading navigation balloon forward by the endoscope lens end, and maintain a distance of 150-200 mm between the leading navigation balloon and the peripheral blocking balloon to form diagnostic or surgical tunnels of the endoscope at different parts of the intestinal tract.

[0043] For example, the leading navigation balloon and the peripheral blocking balloon can reach the sigmoid colon, descending colon, transverse colon, ascending colon, cecum, and even the ileum in turn. Under the blocking effect of the leading navigation balloon and the peripheral blocking balloon, a stable diagnostic or surgical tunnel of the endoscope is formed at each part by injecting gas.

[0044] S7. When the pilot navigation balloon reaches the ileum, the liquid or medical gas of the pilot balloon is released using endoscopic surgical instruments, causing the pilot navigation balloon to retract to its initial state. The pilot navigation balloon is then held in place by an endoscopic hook or surgical forceps and slowly withdrawn from the intestine together with the endoscope tip.

[0045] The clinical applications of this application include assisting in the insertion of the endoscope for colonoscopy or endoscopic surgery, effectively controlling the leakage of injected gas, creating an endoscopic diagnostic or surgical tunnel between the tip navigation balloon and the peripheral occlusion balloon, and improving the local diagnostic field or endoscopic surgical field in the intestine.

[0046] The beneficial effects of this application are that, during intestinal endoscopic diagnosis or surgery, the synergistic use of the advanced navigation balloon and the peripheral occlusion balloon, utilizing the compliance of the advanced navigation balloon to open the intestine and then slowly gliding under the drive of the posterior air pressure, facilitates smoother endoscope insertion by the surgeon, avoiding difficulties in insertion or intestinal perforation. Simultaneously, the combined anterior and posterior occlusion of the advanced navigation balloon and the peripheral occlusion balloon within the intestine allows for segmented advancement and inflation, forming stable endoscopic diagnostic or surgical tunnels in different intestinal regions. This not only improves the efficiency of endoscopic diagnosis or surgery but also avoids adverse consequences such as abdominal distension and pain caused by excessive air intake, reducing the risks of endoscopic diagnosis or surgery. This application is simple to operate, safe, and reliable, and is worthy of widespread clinical application. Attached Figure Description

[0047] Figure 1 This is a schematic diagram of the overall structure of one embodiment of this application.

[0048] Figure 2 This is a schematic diagram illustrating the clinical application of one embodiment of this application.

[0049] The diagram shows: 10 pilot navigation balloon, 11 pilot balloon, 12 support rod, 13 sealing device, 14 drainage hole, 20 injector, 21 injector head, 22 injector cavity, 23 injector handle, 30 peripheral occlusion balloon, 31 annular occlusion balloon, 32 capillary tube, 33 elastic collar, 34 sealing connector, 35 tip of endoscope, 36 rectum, 37 anus. Detailed Implementation

[0050] The present application will now be described in detail with reference to the accompanying drawings and embodiments.

[0051] Example 1: Preparation of an advanced navigation balloon 10 and a peripheral occlusion balloon 30

[0052] 1. Preparation of the advanced navigation balloon 10

[0053] like Figure 1 As shown in the structure, the components of this application are manufactured.

[0054] 1.1 Preparation of the pilot balloon 11

[0055] 1.1.1 The plastic extrusion mold for preparing the pilot balloon 11 preform was made of polyurethane material and extruded using precision extrusion equipment. The preform was then cut into 30mm long tubes for use as pilot balloon 11 preforms.

[0056] 1.1.2 Preparation of the blow molding mold for the pilot balloon 11 preform. The pilot balloon 11 preform undergoes secondary molding under low temperature and low pressure conditions, resulting in a mushroom shape. Specifically, the pilot balloon 11 preform is placed in the blow molding mold, nitrogen gas is introduced, and the low pressure is maintained at 2.6 MPa. The mold temperature is gradually increased to 110℃. The stretching speed of the clamps at both ends is 70 mm / s, and the stretching distance is 50 mm to produce a thinner cone and neck wall thickness. Then, heating and pressure holding are applied to allow the formed balloon to complete crystal orientation. After cooling and demolding, the pilot balloon 11 is removed, and the excess preform used for stretching at both ends is trimmed, resulting in a pilot balloon 11 wall thickness of 0.1 mm, an overall length of 42 mm (6 mm for each neck length at both ends), a neck inner diameter of 5 mm, and a maximum diameter of 80 mm (calculated based on maximum expansion value), ready for use.

[0057] 1.2 Preparation of support rod 12

[0058] 1.2.1 Prepare the tube extrusion mold 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.

[0059] 1.2.2 The material is processed using high-precision plastic extrusion equipment. After cooling and shaping, it is cut into support rods 12 with a length of 50mm.

[0060] 1.2.3 A pipe drilling device is used to drill a 2.0mm guide hole 14 on the outer periphery of the support rod 12.

[0061] 1.2.4 Use pipe head heat fusion sealing equipment to heat fused the head end of the support rod 12 into an R angle and completely close the liquid injection channel of the support rod 12 for later use.

[0062] 1.3 The sealing device 13 adopts a spring check valve with a Luer interface, and the outer diameter of the protrusion connecting to the support rod 12 is 2.4mm. Medical adhesive is used to seal the sealing device 13 and the tail end of the support rod 12 in an internal connection manner.

[0063] 1.4 Insert the pilot balloon 11 prepared in step 1 into the head end of the support rod 12, and use a high-frequency heat sealing device to seal the pilot balloon 11 around the outer periphery of the support rod 12. The tail end of the support rod 12 and the sealing device 13 should be exposed above the pilot balloon 11.

[0064] 1.5 Check the airtightness of the assembled or bonded parts, and put them into storage if they pass the inspection.

[0065] 2. Preparation of peripheral occlusion balloon 30

[0066] 2.1 Preparation of the annular occlusion capsule 31: Referring to the process flow in 1.1, the annular occlusion capsule 31 is prepared using silicone rubber material. The annular occlusion capsule 31 is required to be donut-shaped, with an inner ring diameter of 11mm, an outer ring diameter of 80mm (calculated based on maximum expansion value), and a height of 25mm. A 2mm-4mm drainage hole 14 is drilled in the inner ring of the annular occlusion capsule 31 using an opening device, for later use.

[0067] 2.2 A double-lumen conduit extrusion die for preparing the elastic collar 33 was used. The conduit had an inner diameter of 9.0 mm and an outer diameter of 11 mm, with a 0.8 mm guide cavity on the conduit wall. The conduit was produced using a silicone rubber conduit extrusion process. After extruding the silicone rubber conduit, it was cut into 22 mm long elastic collars 33. Then, using a drilling device, a 0.6 mm guide hole 14 was drilled on the outer wall of the guide cavity located at the center point of the elastic collar 33.

[0068] 2.3 An extrusion die for the capillary tube 32 was prepared using polyurethane. The outer diameter of the capillary tube 32 was 0.78 mm, and the inner diameter was 0.5 mm. It was processed using high-precision plastic extrusion equipment. After cooling and setting, it was slit into capillary tubes 32 with a length of 35 mm. These were then set aside.

[0069] 2.4 Bonding of various components

[0070] 2.4.1 The head end of the capillary tube 32 is bonded to the upper end of the flow guiding cavity of the elastic collar 33 using medical adhesive, and the lower end of the flow guiding cavity of the elastic collar 33 is sealed using medical adhesive; the tail end of the capillary tube 32 is sealed and bonded to the sealing joint 34, which is a spring check valve.

[0071] 2.4.2 The inner ring of the annular occlusion bladder 31 is fitted onto the outer circumference of the elastic collar 33, and the drainage hole 14 of the annular occlusion bladder 31 is aligned with the drainage hole 14 of the elastic collar 33. Medical adhesive is used to seal and bond the inner ring of the annular occlusion bladder 31 to the elastic collar 33.

[0072] 2.4.3 Check the airtightness of the assembled or bonded parts, and put them into storage if they pass the inspection.

[0073] The injector 20 can be directly adopted from existing injectors 20 or injector applicators, which is a conventional production process, and the preparation process will not be described in detail.

[0074] Example 2: Clinical application of this application in endoscopic examination

[0075] like Figure 2 As shown, the product prepared in Example 1 of this application was used for intestinal endoscopy. The specific application steps are as follows:

[0076] 1. Using a 50ml medical syringe as the injector 20, with the injector head 21 being a Luer connector, 40ml of sterile saline is drawn. The spring-loaded one-way valve Luer connector at the bottom of the tip navigation balloon 10 prepared in Example 1 is connected to the injector head 21 of the injector 20.

[0077] 2. Insert the elastic collar 33 of the peripheral occlusion balloon 30 into the endoscope part and pull it to a position 20mm-30mm downstream of the curved part of the endoscope.

[0078] 3. Apply an appropriate amount of glycerin as a lubricant around the patient's anus 37. Gently push the pilot navigation balloon 10 into the patient's rectum 36, press the injection handle 23, and inject 30ml of normal saline into the pilot balloon 11 to allow the pilot balloon 11 to expand and anchor in the rectum 36.

[0079] 4. Insert the endoscope into the rectum 36 through the anus 37 until the peripheral occlusion balloon 30 enters the anus 37, keeping the end of the capillary tube 32 and the sealing connector 34 exposed around the anus 37.

[0080] 5. Following the methods in steps 1 and 3, connect the injector 20 with the sealing connector 34 and inject 20mm-30mm of physiological saline into the annular occlusion bladder 31 to inflate the annular occlusion bladder 31.

[0081] 6. Inject carbon dioxide gas into the rectum 36 through the endoscopic insufflation channel and check the gas leakage status around the anus 37. If the amount of leaked gas is large, continue to inject physiological saline into the annular occlusion sac 31.

[0082] 7. Under direct endoscopic visualization, the endoscope tip continues to advance the pilot navigation balloon 10, anchoring it at the junction of rectum 36 and sigmoid colon. At this point, a stable endoscopic diagnostic tunnel is formed between the pilot navigation balloon 10 and the peripheral occlusion balloon 30, facilitating direct endoscopic visualization and imaging of various parts inside rectum 36.

[0083] 8. After the examination of the 36 parts of the rectum is completed, continue to advance the tip navigation balloon 10 according to the method in step 7, and establish tunnels in each part in sequence, and perform endoscopic visualization and photography of the sigmoid colon, descending colon, transverse colon, ascending colon and cecum in sequence.

[0084] 9. After the examination, insert surgical forceps into the instrument channel of the endoscope and use the forceps to puncture the pilot balloon 11, causing the fluid inside the pilot balloon 11 to leak out. Clamp the tip navigation balloon 10 with surgical forceps and withdraw it from the body along with the endoscope. Remove the peripheral occlusion balloon 30 from the endoscope; this operation is now complete.

[0085] During intestinal endoscopic surgery, based on the endoscopic diagnosis, the lesion site can be located and an endoscopic surgical tunnel can be established to perform endoscopic polyp removal and other surgeries. Specific methods are detailed in steps 1 to 9, and will not be elaborated further.

[0086] The above figures and embodiments are only used to illustrate the technical solutions of this application and are not intended to limit it. Although this application has been described in detail with reference to preferred embodiments, those skilled in the art should understand that modifications or equivalent substitutions can be made to the technical solutions of this application without departing from the spirit and scope of the technical solutions of this application. All such modifications or substitutions should be covered within the scope of the claims of this application and do not constitute any limitation on the scope of protection of this application.

Claims

1. A device for creating an endoscopic tunnel during colonoscopy or surgery, comprising a pilot navigation balloon (10), a peripheral occlusion balloon (30), and an injector (20); wherein the pilot navigation balloon (10) mainly consists of a pilot balloon (11), a support rod (12), and a sealing device (1313); and the peripheral occlusion balloon (30) comprises an annular occlusion balloon (31), a capillary tube (32), an elastic collar (33), and a sealing connector (34); characterized in that: The support rod (12) has a flow channel inside, and the support rod (12) should have at least one flow hole (14) for the flow channel to communicate with the inner cavity of the pilot balloon (11). The pilot balloon (11) is sealed and assembled on the outer periphery of the support rod (12), and the sealing device (1313) is sealed and assembled with the tail of the support rod (12). The annular occlusion balloon (31) is a thin film cavity with an annular structure made of elastic medical polymer material. The collar (33) is set in the inner ring of the annular occlusion bladder (31) and is sealed together with the inner ring of the annular occlusion bladder (31); the outer wall of the head end of the capillary (32) is sealed together with the inside of the elastic collar (33), and the inner cavity of the capillary (32) is connected to the inner cavity of the annular occlusion bladder (31); the sealing connector (34) is sealed together with the tail end of the capillary (32), and the water / air channel of the sealing connector (34) is connected to the inner cavity of the capillary (32).

2. The device for creating an endoscopic tunnel during colonoscopy or surgery according to claim 1, characterized in that: The pilot balloon (11) is a hollow membrane cavity made of elastic medical polymer material. The membrane cavity can be injected with water or gas to expand, and can be folded back after water or gas is extracted.

3. The device for creating an endoscopic tunnel during colonoscopy or surgery according to claim 1, characterized in that: The sealing device (1313) adopts a one-way push-in connector, which is sealed together with the tail of the support rod (12) and seals the flow channel.

4. The device for creating an endoscopic tunnel during colonoscopy or surgery according to claim 1, characterized in that: The overall shape of the advanced navigation balloon (10) adopts a cone-shaped balloon structure with a small head and a large tail, or an umbrella-shaped balloon structure. When inflated, it presents a shape including mushroom, pear, or bullet.

5. The device for creating 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-slippery coating, which can reduce the friction between the tip navigation balloon (10) and the intestinal wall and increase the compliance of the endoscope when it is inserted into the intestine.

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

7. The device for creating an endoscopic tunnel during colonoscopy or surgery according to claim 1, characterized in that: The elastic collar (33) is integrally formed with the annular occlusion bladder (31), and the elastic collar (33) is located in the inner ring of the annular occlusion bladder (31).

8. The device for creating an endoscopic tunnel during colonoscopy or surgery according to claim 1, characterized in that: A limiting device is also provided between the advanced navigation balloon (10) and the peripheral occlusion balloon (30), and the limiting device is a tensile flexible wire.

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