A degradable balloon device for preventing intestinal anastomotic leakage

Abstract

The present invention discloses a degradable balloon device for preventing intestinal anastomotic leakage, which includes a plurality of sheet-shaped balloons. The plurality of sheet-shaped balloons are internally connected and interconnected to form a tubular inflation structure with a hollow interior and open ends. An air inlet and an air outlet are provided on the tubular inflation structure, and an air inlet pipe and an exhaust pipe are respectively communicated with the air inlet and the air outlet. A bionic adhesion surface structure is formed on the outer side surface of the sheet-shaped balloon; the tubular inflation structure is inflated and expanded to form a tubular structure, and the outer side of the inflated tubular inflation structure closely adheres to the inner surface of the intestinal wall at the anastomotic site to form a support and sealing structure, and the tubular inflation structure deflates and collapses and contracts inward for removal. Through the innovative balloon design and bionic fixation, it can form multiple sealing layers around the anastomotic site, ensure that the device does not displace during the tissue repair process, effectively protect the intestinal anastomotic site from being affected by the dirt in the intestine, prevent the leakage of intestinal contents, and reduce the occurrence of anastomotic leakage.

Description

Technical Field

[0001] The present invention relates to the technical field of medical devices, and particularly relates to a degradable balloon device for preventing intestinal anastomotic leakage. Background Art

[0002] In the treatment of digestive system diseases, intestinal anastomosis is a crucial surgery, and various diseases such as intestinal tumors and intestinal traumas all require this surgery. However, intestinal anastomotic leakage is one of the common and serious complications after intestinal anastomosis surgery, especially more prominent in colorectal surgery, with an incidence rate between 2.4 - 15.9%. Once it occurs, it may lead to severe infections, peritonitis, and even endanger life. The occurrence of intestinal anastomotic leakage not only prolongs the hospital stay but also increases the patient's pain and medical expenses.

[0003] To prevent intestinal anastomotic leakage, clinically, a secondary surgery of prophylactic stoma is usually performed. This secondary surgery creates a stoma on the intestine to drain intestinal contents into an external collection bag, thereby avoiding pressure and contamination on the anastomotic site. However, this method brings additional trauma to the patient and inconvenience in daily life because the patient needs to adapt to the use and care of the ostomy bag. Therefore, there is an urgent need for a new type of device to effectively prevent intestinal anastomotic leakage, reduce the incidence of postoperative complications, and promote the patient's recovery. Summary of the Invention

[0004] In order to solve the situation that the existing stoma means for preventing intestinal anastomotic leakage brings additional trauma and discomfort to the patient during the secondary surgery, the present invention provides a degradable balloon device for preventing intestinal anastomotic leakage. Through an innovative balloon design and bionic fixation, it can form multiple sealing layers around the anastomotic site, ensure that the device does not displace during the tissue repair process, effectively protect the intestinal anastomotic site from being affected by intestinal dirt, prevent the leakage of intestinal contents, reduce the occurrence of anastomotic leakage, promote postoperative healing, and improve the postoperative recovery effect of the patient.

[0005] To achieve the above object, the present invention adopts the following technical solutions:

[0006] The present invention provides a degradable balloon device for preventing intestinal anastomotic leakage, including a plurality of sheet-shaped balloons, an air inlet, an air outlet, an air inlet pipe, and an exhaust pipe;

[0007] The interiors of the plurality of sheet-shaped balloons are connected and communicate with each other to form a tubular inflatable structure with a hollow interior and two open ends. The tubular inflatable structure is provided with an air inlet and an air outlet, and the air inlet and the air outlet are respectively communicated with an air inlet pipe and an exhaust pipe. A bionic adhesion surface structure is formed on the outer side surface of the sheet-shaped balloon;

[0008] The tubular inflatable structure is inflated and expanded to form a tubular structure. The outer side of the inflated tubular inflatable structure closely adheres to the inner surface of the intestinal wall at the anastomosis to form a support and sealing structure. The tubular inflatable structure deflates and collapses, contracting inward. After contraction, the outer side of the tubular inflatable structure separates from the inner surface of the intestinal wall at the anastomosis and is removed.

[0009] Adopting the above technical solution:

[0010] Using a tubular inflatable structure formed by connecting multiple sheet-shaped airbags as the main body, which can provide sufficient support after inflation to help the anastomosis resist external forces. The internal hollow structure is used for draining intestinal contents. The outer side of the sheet-shaped airbag is formed with a bionic adhesion surface structure, which increases the compressive stress and friction between the sheet-shaped airbag and the intestinal wall, ensuring the fixation of the sheet-shaped airbag upstream and downstream of the anastomosis, and ensuring that there will be no displacement or shedding during the tissue repair process. This makes the tubular inflatable structure closely adhere to the anastomosis, providing protection and preventing anastomotic leakage and secondary postoperative infection and poor healing. After deflation, the sheet-shaped airbag will collapse, facilitating direct removal.

[0011] Furthermore, the outer side of the sheet-shaped airbag is made of biodegradable polyurethane material, and the inner side of the sheet-shaped airbag is made of polytetrafluoroethylene material.

[0012] The outer surface of the sheet-shaped airbag close to the intestinal wall is made of a flexible and durable polyurethane material, which can provide sufficient support after inflation. The inner surface of the sheet-shaped airbag away from the intestinal wall uses polytetrafluoroethylene material, which has a low surface energy and can prevent fouling and the residue of intestinal contents. Except for the inner surface of the airbag using polytetrafluoroethylene material, the rest of the device is made of biodegradable polyurethane material, ensuring that the device can naturally degrade after completing its task and will not cause long-term effects on the human body, and the polytetrafluoroethylene material can also be excreted from the body by itself.

[0013] Furthermore, the inner side and the outer side of the sheet-shaped airbag are both chemically modified with a chitosan quaternary ammonium salt molecular brush coating.

[0014] In specific applications, the inner side of the sheet-shaped airbag made of polytetrafluoroethylene and the outer side of the polyurethane surface are both chemically modified with a chitosan quaternary ammonium salt molecular brush coating, which can improve the antibacterial property, surface hydrophilicity and biocompatibility of the biodegradable airbag device.

[0015] Furthermore, the specific process of chemically modifying the inner side and the outer side of the sheet-shaped airbag with a chitosan quaternary ammonium salt molecular brush coating is as follows:

[0016] S1. React a sodium-naphthalene treatment solution with a molar ratio of sodium to naphthalene of 1:1 and a tetrahydrofuran solvent at room temperature for 1 - 5 h to obtain a mixed solution A, and coat the mixed solution A on the inner side and the outer side of the sheet-shaped airbag for pretreatment;

[0017] S2. Add 1-4 wt% of glycerol and 0.1-0.5 wt% of glutaraldehyde to a 1-10 g / L chitosan quaternary ammonium salt solution to obtain a mixed solution B. Uniformly coat the mixed solution B on the inner and outer sides of the pretreated sheet-shaped airbag, and cure it at 60 °C to form a chitosan quaternary ammonium salt molecular brush coating on the inner and outer sides of the sheet-shaped airbag.

[0018] Furthermore, the bionic adhesion surface structure is a multi-level hexagonal protrusion array structure imitating the tree frog foot pad.

[0019] The outer surface of the sheet-shaped airbag close to the intestinal wall is a bionic adhesion surface structure, imitating the hexagonal multi-level protrusion array of the tree frog foot pad. This array not only excludes the interfacial water on the surface of the intestinal wall tissue, but also forms a firm adhesion with the intestinal wall tissue by capillary force. The bionic adhesion surface structure can fix the degradable sheet-shaped airbag upstream and downstream of the anastomosis to ensure that the airbag device does not displace during the tissue repair process.

[0020] Furthermore, an intake check valve is provided inside the intake pipe, and a pressure sensor is provided between the intake pipe and an external air pump.

[0021] The intake pipe is made of a degradable polyurethane material, which is flexible and pressure-resistant, thus ensuring smooth gas flow. It connects the tubular inflatable structure and the external air pump, and is used to transport gas into the tubular inflatable structure. An intake check valve is built into the intake pipe to prevent gas from flowing back and ensure stable pressure after inflation. A commercial pressure sensor can be grafted between the intake pipe and the external air pump, and the gas flow and pressure can be automatically adjusted according to real-time monitoring data.

[0022] Furthermore, a rotary valve is provided at the end of the exhaust pipe, and an air flow control device is installed inside the rotary valve.

[0023] The exhaust pipe is used to control the discharge of gas from the airbag and deflate it after the protection device needs to be adjusted or after use. The exhaust pipe is also made of a flexible degradable polyurethane material. A rotary valve is designed at the end of the exhaust pipe to ensure smooth and controllable gas discharge. The valve at the end of the exhaust pipe is designed with an air flow control device, which can control the flow rate and velocity of the air flow to prevent irritation to the intestine.

[0024] Furthermore, a micro sensor for detecting pressure and temperature is placed inside the tubular inflatable structure.

[0025] In specific applications, a commercial micro sensor can be placed inside the sheet-shaped airbag to be able to real-time monitor the pressure and temperature at the anastomosis to ensure the best healing environment.

[0026] Compared with the prior art, the present invention has the following beneficial effects:

[0027] 1. Prevent anastomotic leakage: Through the combination of multi-layer sheet-shaped airbags and bionic adhesion surface structures, multiple sealing layers can be formed around the anastomosis, providing effective support to help the anastomosis resist external forces. The internal hollow structure is used to drain intestinal contents, effectively preventing the leakage of intestinal contents and ensuring the integrity of the anastomosis.

[0028] 2. Enhance the stability of the anastomosis: Through the design of the bionic adhesion surface structure, the compressive stress and friction between the sheet-shaped airbag and the intestinal wall are increased, enabling a firm adhesion to be formed around the anastomosis, enhancing the stability of the anastomosis, and reducing the risk of postoperative displacement.

[0029] 3. Non-invasive personalized implantation: The degradable airbag device can be first implanted upstream and downstream of the anastomosis, and then inflated and expanded in the intestinal cavity by an external air pump to form protection. The inflation degree and position of the device can be adjusted personalized according to the specific situation of the patient to provide the best protection effect.

[0030] 4. No need for secondary surgery to remove: All materials are composed of degradable polyurethane and self-drainable polytetrafluoroethylene materials, which will not cause long-term effects on the human body.

[0031] 5. Improve the antibacterial property of the device: The inner and outer surfaces of the sheet-shaped airbag, namely the polytetrafluoroethylene and polyurethane surfaces, are chemically modified with quaternary ammonium salt chitosan molecular brush coatings, which can improve the antibacterial property, surface hydrophilicity, and biocompatibility of the degradable airbag device.

[0032] 6. Reduce the physical and mental pain and economic burden of patients: By reducing postoperative complications and shortening the hospital stay, patients can recover to normal life faster, reducing the psychological pressure and economic burden caused by long-term hospitalization. At the same time, the design of the device is simple, reducing the complexity and time of postoperative care, and further reducing the overall medical expenses of patients. Description of the Drawings

[0033] The present invention will be further described in detail below in conjunction with the drawings and specific embodiments.

[0034] Figure 1 It is a schematic diagram of the overall structure of the degradable airbag device in the present invention;

[0035] Figure 2 It is a schematic diagram of the outer side of the degradable airbag device in the present invention in the deployed state;

[0036] Figure 3 It is a 3D modeling diagram of the bionic adhesion surface structure in the present invention, with a modeling accuracy reaching the micron level and including a two-level convex structure;

[0037] Figure 4 It is a schematic diagram of the inner side of the degradable airbag device in the present invention in the deployed state;

[0038] Figure 5 This is a schematic diagram of the usage state of the degradable balloon device of the present invention placed at the anastomosis site;

[0039] Figure 6 This is the water contact angle experiment on the surface of the polyurethane material modified with chitosan quaternary ammonium salt molecular brush of the present invention;

[0040] Figure 7 This is the fluorescence staining pattern of the anti - Escherichia coli experiment of the polyurethane material and polytetrafluoroethylene material modified with chitosan quaternary ammonium salt molecular brush of the present invention;

[0041] Among them, the specific reference numerals are:

[0042] Sheet - shaped balloon 1, bionic adhesion surface structure 2, tubular inflation structure 3, air inlet 4, air outlet 5, inlet pipe 6, exhaust pipe 7. Specific embodiments

[0043] The following will clearly and completely describe the technical solutions in the embodiments of the present invention with reference to the accompanying drawings in the embodiments of the present invention. Obviously, the described embodiments are only a part of the embodiments of the present invention, rather than all embodiments. Based on the embodiments of the present invention, all other embodiments obtained by those of ordinary skill in the art without creative efforts shall fall within the protection scope of the present invention.

[0044] Embodiment 1

[0045] A degradable balloon device for preventing intestinal anastomotic leakage, as Figures 1 to 5 shown, includes a plurality of sheet - shaped balloons 1, an air inlet 4, an air outlet 5, an inlet pipe 6 and an exhaust pipe 7; the plurality of sheet - shaped balloons 1 are internally connected and form a tubular inflation structure 3 with a hollow interior and two open ends. The tubular inflation structure 3 is provided with an air inlet 4 and an air outlet 5, and the air inlet 4 and the air outlet 5 are respectively connected to an inlet pipe 6 and an exhaust pipe 7. The outer side of the sheet - shaped balloon 1 is formed with a bionic adhesion surface structure 2; the tubular inflation structure 3 inflates and expands to form a tubular structure, and the outer side of the expanded tubular inflation structure 3 closely adheres to the inner surface of the intestinal wall at the anastomosis site to form a support and sealing structure. The tubular inflation structure 3 deflates and collapses inward, and the outer side of the collapsed tubular inflation structure 3 separates from the inner surface of the intestinal wall at the anastomosis site for removal. In specific applications, the number of sheet - shaped balloons 1 is an even number, and the sheet - shaped balloons 1 are sequentially connected to form a cylindrical structure with two open ends and a hollow interior. When inflated, the sheet - shaped balloons 1 expand to form a hollow tubular structure, and after deflation, the sheet - shaped balloons 1 collapse into sheets, and the tubular inflation structure 3 shrinks into a sheet structure. In this embodiment, there are 8 sheet - shaped balloons 1, and 2 sheet - shaped balloons 1 are in a group, and four groups of sheet - shaped balloons are connected to form a cylindrical structure with two open ends and a hollow interior.

[0046] A tubular inflatable structure 3 formed by connecting multiple sheet-shaped airbags 1 is used as the main body. After inflation, it can provide sufficient support to help the anastomotic stoma resist external forces. The internal hollow structure is used to drain intestinal contents. A bionic adhesion surface structure 2 is formed on the outer side of the sheet-shaped airbag 1, which increases the compressive stress and frictional force between the sheet-shaped airbag 1 and the intestinal wall, ensuring the fixation of the sheet-shaped airbag 1 upstream and downstream of the anastomotic stoma, and ensuring that there is no displacement or shedding during the tissue repair process. This makes the tubular inflatable structure 3 closely adhere to the anastomotic stoma, providing protection and preventing anastomotic leakage and secondary postoperative infection and poor healing. After deflation, the sheet-shaped airbag 1 will collapse, facilitating direct removal.

[0047] Among them, the outer side of the sheet-shaped airbag 1 is made of degradable polyurethane material, and the inner side of the sheet-shaped airbag 1 is made of polytetrafluoroethylene material. The outer surface of the sheet-shaped airbag 1 close to the intestinal wall is made of a flexible and durable polyurethane material, which can provide sufficient support after inflation. The inner surface of the sheet-shaped airbag 1 far from the intestinal wall uses polytetrafluoroethylene material, which has a low surface energy and can prevent fouling and the residue of intestinal contents. Except for the inner surface of the airbag using polytetrafluoroethylene material, the rest of the device is made of degradable polyurethane material, ensuring that the device can naturally degrade after completing its task and will not cause long-term effects on the human body, and the polytetrafluoroethylene material can also be excreted from the body by itself.

[0048] Among them, an intake check valve is provided inside the intake pipe 6, and a pressure sensor is provided between the intake pipe 6 and the external air pump. The intake pipe 6 is made of degradable polyurethane material, with a flexible texture and pressure resistance, thus ensuring smooth gas flow. It connects the tubular inflatable structure 3 and the external air pump, and is used to transport gas into the tubular inflatable structure 3. The intake check valve is built into the intake pipe 6 to prevent gas from flowing back and ensure stable pressure after inflation. A commercial pressure sensor can be grafted between the intake pipe 6 and the external air pump, and the gas flow and pressure can be automatically adjusted according to the real-time monitoring data.

[0049] Among them, a rotary valve is provided at the end of the exhaust pipe 7, and an air flow control device is installed inside the rotary valve. The exhaust pipe 7 is used to control the discharge of gas from the airbag, and deflate after the protection device needs to be adjusted or after use. The exhaust pipe 7 is also made of flexible degradable polyurethane material. A rotary valve is designed at the end of the exhaust pipe 7 to ensure smooth and controllable gas discharge. The valve at the end of the exhaust pipe 7 is designed with an air flow control device, which can control the flow rate and velocity of the air flow and prevent irritation to the intestine.

[0050] Among them, a micro sensor for detecting pressure and temperature is placed inside the tubular inflatable structure 3. In specific applications, a commercial micro sensor can be placed inside the sheet-shaped airbag 1, which can real-time monitor the pressure and temperature of the anastomotic stoma to ensure the best healing environment.

[0051] Among them, the bionic adhesion surface structure 2 is a multi-level hexagonal protrusion array structure imitating the tree frog foot pad. The outer surface of the sheet-shaped airbag 1 close to the intestinal wall is the bionic adhesion surface structure 2, which imitates the hexagonal multi-level protrusion array of the tree frog foot pad. This array not only excludes the interfacial water on the surface of the intestinal wall tissue, but also forms a firm adhesion with the intestinal wall tissue by capillary force. The bionic adhesion surface structure 2 can fix the degradable sheet-shaped airbag 1 upstream and downstream of the anastomosis, ensuring that the airbag device will not be displaced during the tissue repair process. As Figure 3 shown, in a specific embodiment, the bionic adhesion surface structure 2 is a two-level hexagonal protrusion array structure imitating the tree frog foot pad. There are channels between the multi-level protrusions. This array structure not only excludes the interfacial water on the surface of the intestinal wall tissue, but also forms a firm adhesion with the intestinal wall tissue by capillary force.

[0052] Among them, the inner and outer sides of the sheet-shaped airbag 1 are chemically modified with a chitosan quaternary ammonium salt molecular brush coating. In specific applications, the inner side of the sheet-shaped airbag 1 made of polytetrafluoroethylene and the outer side made of polyurethane are chemically modified with a chitosan quaternary ammonium salt molecular brush coating, which can improve the antibacterial property, surface hydrophilicity and biocompatibility of the degradable airbag device.

[0053] Specifically, the specific process of chemically modifying the inner and outer sides of the sheet-shaped airbag 1 with a chitosan quaternary ammonium salt molecular brush coating is as follows:

[0054] S1. React a sodium-naphthalene treatment solution with a molar ratio of sodium to naphthalene of 1:1 and a tetrahydrofuran solvent at room temperature for 1-5 h to obtain a mixed solution A, and coat the mixed solution A on the inner and outer sides of the sheet-shaped airbag for pretreatment;

[0055] S2. Add 1-4 wt% of glycerol and 0.1-0.5 wt% of glutaraldehyde to a 1-10 g / L chitosan quaternary ammonium salt solution to obtain a mixed solution B, and uniformly coat the mixed solution B on the inner and outer sides of the pretreated sheet-shaped airbag, and cure at 60 °C to form a chitosan quaternary ammonium salt molecular brush coating on the inner and outer sides of the sheet-shaped airbag.

[0056] Figure 6 This is the water contact angle experiment of the surface of the polyurethane material modified with the chitosan quaternary ammonium salt molecular brush. The surface of the polyurethane material modified with the chitosan quaternary ammonium salt molecular brush shows good hydrophilicity.

[0057] Figure 7The fluorescence staining pattern of the anti-E. coli experiment of the polyurethane material and polytetrafluoroethylene material modified with chitosan quaternary ammonium salt molecular brush, among which the blank control group (polyurethane material without chitosan quaternary ammonium salt molecular brush coating on the surface) has obvious fluorescence, indicating that there are a large number of E. coli. The other two groups have basically no fluorescence, which proves its antibacterial ability and shows that the inner polytetrafluoroethylene and outer polyurethane surfaces of the sheet airbag 1 are chemically modified with chitosan quaternary ammonium salt molecular brush coating, which can improve the antibacterial property of the degradable airbag device.

[0058] Example 2

[0059] The production process of the degradable airbag device:

[0060] 1) Material selection:

[0061] a) A flexible and degradable polyurethane material is used as the tubular inflatable structure 3 close to the outer surface of the intestinal wall to ensure that it can expand when inflated and shrink in volume after deflation.

[0062] b) The inner surface of the tubular inflatable structure 3 away from the intestinal wall is made of polytetrafluoroethylene material with anti-fouling properties.

[0063] c) The intake pipe 6 and the exhaust pipe 7 are also made of biodegradable polyurethane.

[0064] 2) Production of biodegradable airbag device:

[0065] a) A degradable polyurethane film with a thickness of 100 μm was prepared by a film-forming process as a tubular inflatable structure 3 close to the outer surface of the intestinal wall. A multi-level hexagonal convex structure imitating the foot pad of a tree frog was given to the surface of the degradable polyurethane film by a hot embossing process.

[0066] b) A polytetrafluoroethylene film with a thickness of 100 μm is prepared by a film-forming process as the inner surface of the tubular inflatable structure 3 away from the intestinal wall, and is cut to match the shape of the outer surface of the tubular inflatable structure 3 .

[0067] c) The intake pipe 6, the intake check valve and the exhaust pipe 7 are prepared by injection molding.

[0068] d) The above structures are assembled together by ultrasonic thermal welding process, and hot pressing is used to separate the whole into 8 distributed airbags.

[0069] Example 3

[0070] Insertion and removal of the biodegradable balloon device:

[0071] 1) Placement at the intestinal anastomosis:

[0072] a) Guide the uninflated degradable balloon device to the intestinal anastomosis of the patient through an endoscope, ensuring that both ends of the device are respectively at the upper and lower ends of the anastomosis, so as to form effective support and protection after inflation.

[0073] 2) Inflation and expansion:

[0074] a) Connect an external air pump to the device through the air inlet pipe 6, and slowly inject gas to gradually expand the degradable balloon device to the required size. During the inflation process, closely monitor the internal pressure to ensure that the balloon provides sufficient support force while avoiding applying excessive pressure to the intestine.

[0075] b) After inflation, confirm the function of the intake check valve to prevent gas from flowing back and ensure that the pressure of the degradable balloon device remains stable.

[0076] 3) Function realization:

[0077] a) After the degradable balloon device expands, it can effectively support and protect the anastomosis, resist mechanical stress, and prevent the occurrence of anastomotic leakage.

[0078] b) The multi-level hexagonal protrusion structure of the bionic tree frog foot pad forms a firm adhesion with the intestinal wall tissue by excluding the interfacial water on the surface of the intestinal wall tissue through capillary force, ensuring that the device will not move or fall off during use.

[0079] 4) Removal as needed:

[0080] a) After use, turn the knob of the rotary air valve to deflate the exhaust pipe 7, causing the tubular inflation structure 3 to collapse for easy direct removal.

[0081] b) When active removal is not required, wait for the polyurethane component of the degradable balloon device to degrade by itself and the polytetrafluoroethylene component to be discharged by itself.

[0082] Although the embodiments of the present invention have been shown and described, for those of ordinary skill in the art, it can be understood that various changes, modifications, substitutions, and variations can be made to these embodiments without departing from the principles and spirit of the present invention. The scope of the present invention is defined by the appended claims and their equivalents.

Claims

1. A degradable balloon device for preventing intestinal anastomotic leakage, characterized in that, It includes multiple sheet-shaped airbags, an air inlet, an air outlet, an air inlet pipe and an exhaust pipe; The interiors of the multiple sheet-shaped airbags are connected and interconnected to form a tubular inflatable structure that is hollow inside and open at both ends. An air inlet and an air outlet are provided on the tubular inflatable structure. The air inlet and the air outlet are respectively connected to an air inlet pipe and an exhaust pipe. A bionic adhesion surface structure is formed on the outer side surface of the sheet-shaped airbag, and the bionic adhesion surface structure is a multi-level hexagonal protrusion array structure that mimics the tree frog foot pad; The tubular inflatable structure is inflated and expanded to form a tubular structure. The outer side of the inflated tubular inflatable structure closely adheres to the inner surface of the intestinal wall at the anastomosis to form a support and sealing structure. The tubular inflatable structure deflates and collapses inward, and the outer side of the contracted tubular inflatable structure is separated from the inner surface of the intestinal wall at the anastomosis respectively for removal; The outer side surface of the sheet-shaped airbag close to the intestinal wall is made of biodegradable polyurethane material, and the inner side surface of the sheet-shaped airbag far from the intestinal wall is made of polytetrafluoroethylene material.

2. The degradable balloon device for preventing intestinal anastomotic leakage according to claim 1, wherein Both the inner side surface and the outer side surface of the sheet-shaped airbag are chemically modified with a chitosan quaternary ammonium salt molecular brush coating.

3. The degradable balloon device for preventing intestinal anastomotic leakage according to claim 2, characterized in that, The specific process of chemically modifying the inner side surface and the outer side surface of the sheet-shaped airbag with a chitosan quaternary ammonium salt molecular brush coating is as follows: S1. React a sodium-naphthalene treatment solution with a molar ratio of sodium to naphthalene of 1:1 and a tetrahydrofuran solvent at room temperature for 1-5 h to obtain a mixed solution A, and coat the mixed solution A on the inner side surface and the outer side surface of the sheet-shaped airbag for pretreatment; S2. Add 1-4 wt% of glycerol and 0.1-0.5 wt% of glutaraldehyde to a 1-10 g / L chitosan quaternary ammonium salt solution to obtain a mixed solution B. Coat the mixed solution B evenly on the inner side surface and the outer side surface of the pretreated sheet-shaped airbag, and cure at 60 °C to form a chitosan quaternary ammonium salt molecular brush coating on the inner side surface and the outer side surface of the sheet-shaped airbag.

4. The degradable balloon device for preventing intestinal anastomotic leakage according to claim 1, characterized in that, An air inlet check valve is provided inside the air inlet pipe, and a pressure sensor is provided between the air inlet pipe and an external air pump.

5. The degradable balloon device for preventing intestinal anastomotic leakage according to claim 4, characterized in that, A rotary valve is provided at the end of the exhaust pipe, and an air flow control device is installed inside the rotary valve.

6. The biodegradable balloon device for preventing intestinal anastomotic leakage according to claim 5, characterized in that, A micro sensor for detecting pressure and temperature is placed inside the tubular inflatable structure.

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