Flexible inflatable protection device for intestinal anastomosis protection

Abstract

The flexible inflatable protection device comprises an inflatable skeleton structure, an air inlet and an air outlet are formed in the inflatable skeleton structure, an air inlet guide pipe is communicated with the air inlet, an air inlet valve is installed at the joint of the air inlet and the air inlet guide pipe, an air outlet valve is installed at the air outlet, and the air inlet guide pipe is communicated with the air outlet. The outer side of the inflatable skeleton structure is coated with an anastomotic stoma protective covering film; the inflatable skeleton structure is inflated to expand and drives the anastomotic stoma protection covering film on the outer side to be opened to form a hollow cylindrical structure with the two ends open, and the openings in the two ends of the expanded inflatable skeleton structure make contact with the inner walls of the upper side and the lower side of the anastomotic stoma respectively to form a supporting sealing structure. And the inflatable skeleton structure is deflated and collapsed to be separated from the inner walls of the upper and lower sides of the anastomotic stoma for removal. The flexible inflatable protection device is simple in structural design, convenient to use, high in applicability, non-invasive in and out, effective in intestinal anastomosis post-operation protection and capable of reducing the occurrence rate of complications.

Description

Technical Field

[0001] The invention relates to the technical field of medical devices, and in particular to a flexible inflatable protection device for protecting intestinal anastomosis. Background Art

[0002] Intestinal anastomosis is very important in the treatment of many digestive system diseases. For example, chronic inflammatory bowel disease often leads to intestinal stenosis or perforation, and intestinal tumor resection causes gaps, both of which require anastomosis of the affected intestinal segments. However, various complications and adverse reactions may occur after intestinal anastomosis, including anastomotic leakage, anastomotic stenosis, infection, etc. Anastomotic leakage is one of the most serious complications and may lead to severe infection and peritonitis. The risk of infection after intestinal anastomosis is also high, especially at the surgical site. Anastomotic stenosis may lead to intestinal obstruction and require further surgical intervention. The occurrence of anastomotic leakage will cause intestinal contents to leak into the abdominal cavity, increasing the risk of infection. These complications will not only prolong hospitalization time, but may also increase patient pain and medical costs.

[0003] In order to protect the anastomosis after intestinal anastomosis, preventive stoma is often used clinically to divert intestinal contents. This method creates a stoma on the intestine to drain the intestinal contents into a collection bag outside the body without affecting the anastomosis. However, this will cause additional trauma and inconvenience in life to patients because they need to adapt to the use and care of stoma bags. Therefore, a new device is urgently needed to protect intestinal anastomosis and reduce the incidence of complications. Summary of the invention

[0004] In order to solve the problem that existing intestinal anastomosis is prone to various adverse complications and requires postoperative protection, while existing preventive stoma means will cause additional trauma and discomfort, the present invention provides a flexible inflatable protection device for intestinal anastomosis protection, which has a simple structural design, is easy to use, has strong applicability, and can be inserted and removed non-invasively, effectively performs post-operative protection of intestinal anastomosis, and reduces the incidence of complications.

[0005] In order to achieve the above object, the present invention adopts the following technical solutions: The present invention provides a flexible inflatable protection device for intestinal anastomosis protection, comprising an inflatable skeleton structure, an air intake duct, an air intake valve, an air exhaust valve and an anastomotic protection film; The inflatable skeleton structure is an internal hollow structure, an air inlet and an air outlet are provided on the inflatable skeleton structure, the air inlet duct is connected to the air inlet, an air inlet valve is installed at the connection between the air inlet and the air inlet duct, an air outlet valve is installed at the air outlet, and the outer side of the inflatable skeleton structure is covered with an anastomotic protective film; The inflatable skeleton structure is inflated and expands, driving the outer anastomotic protective film to expand to form a cylindrical structure with openings at both ends and a hollow interior. The openings at both ends of the inflatable skeleton structure after expansion are respectively in contact with the upper and lower inner walls of the anastomosis to form a supporting sealing structure. The inflatable skeleton structure is deflated and collapses, driving the outer anastomotic protective film to shrink. The openings at both ends of the inflatable skeleton structure after shrinkage are respectively separated from the upper and lower inner walls of the anastomosis to be removed.

[0006] Using the above technical solution: The inflatable skeleton structure is used as the main body and is covered with an anastomotic protective film. After inflation, the inflatable skeleton structure inflates and expands and drives the outer anastomotic protective film to expand to form a cylindrical structure with openings at both ends and a hollow interior. The two end portions of the inflatable skeleton structure are tightly sealed with the intestinal inner walls upstream and downstream of the anastomosis and provide supporting force, thereby helping the anastomosis to resist mechanical stress. One side of the anastomotic protective film fits the intestinal wall to play a further sealing and protective role. The internal hollow structure is used to drain the intestinal contents to prevent postoperative infection and anastomotic leakage. After deflation, the inflatable skeleton structure collapses and drives the outer anastomotic protective film to contract. The contracted flexible inflatable protective device is separated from the intestinal inner wall, which is convenient for direct removal and can be discharged by the patient later.

[0007] Furthermore, the inflatable skeleton structure includes at least two longitudinal airways and multiple transverse C-shaped airbags, the longitudinal airways are arranged longitudinally side by side, the outer sides of both ends of the longitudinal airways are respectively connected by at least two transverse C-shaped airbags, and the adjacent transverse C-shaped airbags located at one end of the longitudinal airway are staggered up and down.

[0008] When designing the inflatable skeleton structure, it is necessary to be able to provide sufficient support force after inflation, so as to assist the anastomosis to resist mechanical stress, and at the same time collapse after deflation, so as to facilitate direct removal. In order to achieve the above functions, the inflatable skeleton structure is specifically designed, which consists of multiple longitudinal airways arranged side by side longitudinally, and the two ends of the multiple longitudinal airways are respectively connected by multiple transverse C-shaped airbags, and the transverse C-shaped airbags are connected to the internal channels of the longitudinal airways as a whole, which is convenient for the inflatable skeleton structure to be inflated and deflated. After inflation, the inflatable skeleton structure forms a structure with a hollow interior and openings at both ends, which is used to drain intestinal contents, and both ends are formed with larger openings by the transverse C-shaped airbags staggered up and down, and provide sufficient support force, and are tightly attached to the intestinal wall to form multiple seals, which is conducive to collecting intestinal contents and reducing spillage.

[0009] Furthermore, the inflatable skeleton structure includes two longitudinal air passages and four transverse C-shaped air bags, and the outer sides of both ends of the longitudinal air passages are respectively connected to two transverse C-shaped air bags that are staggered up and down.

[0010] Since the product is specifically applied to the intestinal anastomosis after intestinal anastomosis, the size of the inflatable skeleton structure after inflation needs to match the size of the intestinal wall at the intestinal anastomosis and be able to provide sufficient support and protection. It is preferred to use an inflatable skeleton structure with a transverse multi-layer C-type airbag structure connected by a longitudinal airway, with a total of 2 longitudinal airways and 4 layers of C-type airbags, a length of 6 cm, and an inner diameter of the C-type airbag of 2 cm.

[0011] Furthermore, the inflatable skeleton structure is made of polyurethane, and the anastomotic protective film is made of polytetrafluoroethylene.

[0012] The inflatable skeleton structure is made of flexible and durable polyurethane material, which can provide sufficient support after inflation to help the anastomosis resist mechanical stress, and collapse after deflation for easy removal. The anastomotic stoma protection film covers the surface of the inflatable skeleton structure, close to the anastomosis, and provides an additional layer of protection to prevent postoperative infection and anastomotic leakage. The anastomotic stoma protection film is made of polytetrafluoroethylene material, which has good biocompatibility and anti-fouling properties. The inlet catheter is made of polyethylene material, which is flexible and pressure-resistant to ensure smooth flow of gas. It connects the inflatable skeleton structure and the external air pump to deliver gas into the inflatable skeleton structure.

[0013] Furthermore, the outer sides of the anastomotic stoma protection coating and the inflatable skeleton structure are rough structures, and a microciliary nano array structure is formed on the outer side of the anastomotic stoma protection coating.

[0014] The intestine has continuous peristalsis and material flow, which puts forward strict requirements on the fixation ability and anti-fouling performance of intestinal medical devices. In the present invention, the anastomotic stoma protection film and the outer side of the inflatable skeleton structure are designed as rough structures to fix the flexible inflatable protection device around the anastomotic stoma, ensuring that it will not move or fall off during use, increasing the compressive stress and friction between the intestinal wall, and ensuring the stability and reliability of the device.

[0015] Preferably, a bionic nanoarray is constructed on the outside of the anastomotic protective film, specifically a gecko-inspired microciliary nanoarray that imitates the microstructure on the gecko's paw. These microstructures play a key role in adhesion, and can form reliable contact and accumulate van der Waals forces on various surfaces, generating strong adhesion. In specific applications, the outside of the anastomotic protective film is close to the intestinal wall, and the surface has a microciliary nanoarray structure, which provides abundant friction, thereby firmly fixing to the intestinal wall.

[0016] Furthermore, the microciliary nanoarray structure includes a uniformly distributed ciliary structure formed on the outside of the anastomotic protective covering by nanolithography technology, and the end of each cilium is forked to form a plurality of shovel-shaped villi.

[0017] Furthermore, the length of cilia is 30-130 μm, and the length of spade-shaped villi is 100-300 nm.

[0018] Furthermore, a porous nano-array structure is formed on the inner side of the anastomotic stoma protective coating, and the interior and gaps of the porous nano-array structure are filled with lubricating liquid.

[0019] In order to improve the anti-fouling performance of the device, an ultra-smooth surface consisting of lubricating liquid and porous nanoarrays inspired by Nepenthes is constructed on the inside of the anastomotic protective film. By infusing various types of lubricating liquids in the micro-nano structure, a smooth, continuous and chemically uniform liquid-liquid surface is obtained. This surface is not wetted by most liquids and presents a very small contact angle recession angle. The oil film on the surface significantly reduces the roughness of the substrate surface and reduces the friction when in contact with external forces. At the same time, the dynamic liquid self-healing layer on the surface greatly increases its service life. In specific applications, this ultra-smooth surface can reduce the friction between the anastomotic protective film and the intestinal contents, prevent adhesion, and is easy to remove.

[0020] Furthermore, the average pore size of the porous nano-array structure is 50-200 nm, the porosity is 50-70%, and the lubricating liquid is perfluoropolyether oil.

[0021] Furthermore, the intake valve is an intake check valve, and the exhaust valve is a pin-type structure valve triggered by an external force.

[0022] The air intake valve adopts a one-way air intake check valve to prevent gas backflow and ensure that the inflatable skeleton structure maintains a stable pressure after inflation. It is made of polyethylene material.

[0023] The exhaust valve adopts an adjustable, external force-triggered ejector-type valve. When the ejector is pushed open from the outside to the inside by an external force, the valve inside opens and the gas is released. When there is no external force holding the ejector, the valve automatically closes due to stress and the air pressure inside the inflatable skeleton structure, and the gas will not be released. When in use, the protective device needs to be adjusted or deflated through a colonoscope after use. The exhaust valve is also made of polyethylene.

[0024] Compared with the prior art, the present invention has the following beneficial effects: 1. Prevent contamination of the anastomosis: Through the design of multi-layer C-type airbags, multiple sealing layers can be formed around the anastomosis, effectively preventing the leakage of intestinal contents and preventing contamination of the anastomosis.

[0025] 2. Reduce postoperative discomfort: The flexible inflatable protection device is made of soft material, which can reduce pressure and friction on surrounding tissues, thereby alleviating patients' postoperative discomfort.

[0026] 3. Non-invasive insertion and removal: The flexible inflatable protective device can be inflated after being inserted into the intestine to form a protective support. When it needs to be removed, it can be deflated through colonoscopy to collapse it, and the patient can expel it by himself.

[0027] 4. Reduce the difficulty of postoperative care: Due to the simple design of the device, compared with traditional ostomy, patients do not need to perform complicated operations during postoperative care, which reduces the difficulty and time of care.

[0028] 5. Strong adaptability: The inflation degree and position of the device are adjustable. The adjustable design enables it to adapt to the anatomical structure and surgical needs of different patients, providing personalized protection effects.

[0029] 6. Reduce medical costs: By reducing postoperative complications and shortening hospital stay, it can effectively reduce patients' medical costs and improve the utilization efficiency of medical resources.

[0030] 7. Multiple bionic functional design: One side of the anastomotic protective film is close to the intestinal wall, and the surface has a microciliary nanoarray structure inspired by geckos, which provides abundant friction and thus firmly fixes to the intestinal wall. The other side of the anastomotic protective film is inspired by pitcher plants, with an ultra-smooth surface composed of lubricating fluid and porous nanoarrays, which gives the medical device good anti-fouling and anti-adhesion properties. BRIEF DESCRIPTION OF THE DRAWINGS

[0031] The present invention is further described in detail below with reference to the accompanying drawings and specific embodiments.

[0032] Figure 1 It is a schematic diagram of the overall structure of the flexible inflatable protective device of the present invention; Figure 2 It is a structural schematic diagram of the inflatable skeleton structure of the present invention; Figure 3 It is a structural schematic diagram of the connection state between the intake duct and the intake valve in the present invention; Figure 4 It is a schematic diagram of the structure of the exhaust valve in the present invention; Figure 5 It is a schematic diagram of the flexible inflatable protection device of the present invention being placed on the anastomotic stoma after intestinal anastomosis and inflated; Figure 6 This is a scanning electron microscope image of the porous nano-array structure on the inner side of the anastomotic protective coating of the present invention; Figure 7 A three-dimensional modeling diagram of the microciliary nanoarray structure on the outer side of the anastomotic protective covering in the present invention; Among them, the specific drawings are marked as: Inflatable skeleton structure 1, longitudinal airway 2, transverse C-shaped airbag 3, air inlet 4, air outlet 5, air inlet duct 6, air inlet valve 7, air outlet valve 8, anastomotic stoma protective film 9. DETAILED DESCRIPTION

[0033] The following will be combined with the drawings in the embodiments of the present invention to clearly and completely describe the technical solutions in the embodiments of the present invention. Obviously, the described embodiments are only part of the embodiments of the present invention, not all of the embodiments. Based on the embodiments of the present invention, all other embodiments obtained by ordinary technicians in this field without creative work are within the scope of protection of the present invention.

[0034] Example 1 A flexible inflatable protection device for intestinal anastomosis protection, such as Figures 1 to 5 As shown, it includes an inflatable skeleton structure 1, an air inlet duct 6, an air inlet valve 7, an exhaust valve 8 and an anastomotic stoma protective coating 9; the inflatable skeleton structure 1 is an internal hollow structure, an air inlet 4 and an exhaust port 5 are provided on the inflatable skeleton structure 1, the air inlet duct 6 is connected to the air inlet 4, an air inlet valve 7 is installed at the connection between the air inlet 4 and the air inlet duct 6, and an exhaust valve 8 is installed at the exhaust port 5, and the outer side of the inflatable skeleton structure 1 is coated with an anastomotic stoma protective coating 9; the inflatable skeleton structure 1 is inflated and expands, and drives the outer anastomotic stoma protective coating 9 to expand to form a cylindrical structure with openings at both ends and a hollow interior, and the openings at both ends of the inflated inflatable skeleton structure 1 are respectively in contact with the upper and lower inner walls of the anastomosis to form a supporting sealing structure, the inflatable skeleton structure 1 is deflated and collapsed, and drives the outer anastomotic stoma protective coating 9 to shrink, and the openings at both ends of the inflatable skeleton structure 1 after shrinkage are respectively separated from the upper and lower inner walls of the anastomosis for removal. The inflatable skeleton structure 1 is used as the main body and is covered with an anastomotic protective film 9. After inflation, the inflatable skeleton structure 1 inflates and expands and drives the outer anastomotic protective film 9 to expand to form a cylindrical structure with two openings at both ends and a hollow interior. The two end portions of the inflatable skeleton structure 1 are tightly sealed with the intestinal inner walls upstream and downstream of the anastomosis and provide supporting force, thereby helping the anastomosis to resist mechanical stress. One side of the anastomotic protective film 9 is in contact with the intestinal wall to play a further sealing and protective role. The internal hollow structure is used to drain the intestinal contents to prevent postoperative infection and anastomotic leakage. After deflation, the inflatable skeleton structure 1 collapses and drives the outer anastomotic protective film 9 to shrink. The shrunken flexible inflatable protective device is separated from the intestinal inner wall, which is convenient for direct removal and can be discharged by the patient later.

[0035] Among them, the inflatable skeleton structure 1 includes at least two longitudinal airways 2 and a plurality of transverse C-type airbags 3. The longitudinal airways 2 are arranged longitudinally side by side. The outer sides of the two ends of the longitudinal airways 2 are respectively connected by at least two transverse C-type airbags 3. The adjacent transverse C-type airbags 3 at one end of the longitudinal airway 2 are arranged alternately up and down. When designing the inflatable skeleton structure 1, it is necessary to be able to provide sufficient support after inflation, so as to assist the anastomosis to resist mechanical stress, and at the same time collapse after deflation, so as to facilitate direct removal. In order to achieve the above functions, the inflatable skeleton structure 1 is specifically designed, which is composed of a plurality of longitudinal airways 2 arranged longitudinally side by side, and the two ends of the plurality of longitudinal airways 2 are respectively connected by a plurality of transverse C-type airbags 3, and the transverse C-type airbags 3 are connected to the internal channels of the longitudinal airways 2 as a whole, so as to facilitate the inflation and deflation operations of the inflatable skeleton structure 1. After inflation, the inflatable skeleton structure 1 forms a structure with a hollow interior and openings at both ends, which is used to drain intestinal contents. In addition, larger openings are formed at both ends by horizontal C-shaped air bags 3 staggered up and down, and provide sufficient support force, tightly adhere to the intestinal wall to form multiple seals, which is conducive to collecting intestinal contents and reducing overflow.

[0036] In a specific embodiment, the inflatable skeleton structure 1 includes two longitudinal airways 2 and four transverse C-type airbags 3, and two transverse C-type airbags 3 arranged in an up-and-down staggered manner are respectively connected to the outer sides of the two ends of the longitudinal airway 2. Since the product is specifically applied to the intestinal anastomosis after intestinal anastomosis, the size of the inflatable skeleton structure 1 after inflation needs to match the size of the intestinal wall at the intestinal anastomosis and be able to provide sufficient support and protection. The inflatable skeleton structure 1 with a transverse multi-layer C-type airbag structure connected by the longitudinal airway 2 is preferably used, with a total of 2 longitudinal airways 2 and 4 layers of C-type airbags, with a length of 6 cm and an inner diameter of the C-type airbag of 2 cm.

[0037] Among them, the inflatable skeleton structure 1 is made of a flexible and durable polyurethane material, which can provide sufficient support after inflation, thereby helping the anastomosis to resist mechanical stress, and at the same time collapse after deflation, which is convenient for direct removal. The anastomotic stoma protection coating 9 covers the surface of the inflatable skeleton structure 1, close to the anastomosis, and provides an additional layer of protection to prevent postoperative infection and anastomotic leakage. The anastomotic stoma protection coating 9 uses polytetrafluoroethylene material, which has good biocompatibility and anti-fouling properties. The air inlet duct 6 is made of polyethylene material, which is flexible and pressure-resistant, thereby ensuring smooth flow of gas. It connects the inflatable skeleton structure 1 and an external air pump to deliver gas to the inflatable skeleton structure 1.

[0038] Among them, the air intake valve 7 is an air intake check valve, and the exhaust valve 8 is an ejector-type structure valve triggered by external force. The air intake valve 7 adopts a one-way air intake check valve, and the air intake check valve is a duckbill one-way valve structure. The duckbill opens when the gas passes in the forward direction, and closes when the gas passes in the reverse direction to prevent the gas from flowing back, ensuring that the inflatable skeleton structure 1 maintains a stable pressure after inflation. It is made of polyethylene material. The exhaust valve 8 adopts an adjustable, external force-triggered ejector-type structure valve. When the ejector is pushed open from the outside to the inside by an external force applied from the outside, the valve inside opens accordingly and the gas is released; and when there is no external force to push the ejector, the valve automatically closes due to stress and the air pressure inside the inflatable skeleton structure 1, and the gas will not be released. When in use, the protective device needs to be adjusted or deflated through a colonoscopy after use. The exhaust valve 8 is also made of polyethylene material.

[0039] The outer sides of the stoma protection film 9 and the inflatable skeleton structure 1 are rough structures, and the outer side of the stoma protection film 9 is formed with a microciliary nano array structure, such as Figure 7 As shown. The microciliary nanoarray structure includes a uniformly distributed ciliary structure formed on the outside of the anastomotic stoma protective film 9 by nanolithography technology, and the end of each cilium is bifurcated to form multiple shovel-shaped villi. The length of the cilia is 30-130 μm, and the length of the shovel-shaped villi is 100-300 nm.

[0040] There is continuous peristalsis and material flow in the intestine, which puts forward strict requirements on the fixation ability and anti-fouling performance of intestinal medical devices. In the present invention, the outer side of the anastomotic protective coating 9 and the inflatable skeleton structure 1 is designed as a rough structure, which is used to fix the flexible inflatable protective device around the anastomotic stoma to ensure that it will not move or fall off during use, thereby increasing the compressive stress and friction between the intestinal wall and the intestinal wall, and ensuring that the device is stable and reliable. Preferably, a bionic nanoarray is constructed on the outer side of the anastomotic protective coating 9, specifically a gecko-inspired microciliary nanoarray that imitates the microstructure on the gecko's paw. These microstructures play a key role in adhesion, and can form reliable contact on various surfaces and accumulate van der Waals forces to generate strong adhesion. In specific applications, the outer side of the anastomotic protective coating 9 is close to the intestinal wall, and the surface has a microciliary nanoarray structure, which provides abundant friction, thereby firmly fixing to the intestinal wall.

[0041] Among them, Figure 6As shown, a porous nano-array structure is formed on the inner side of the anastomotic protective coating 9, and the inside and gaps of the porous nano-array structure are filled with lubricating liquid. The average pore size of the porous nano-array structure is 50-200nm, the porosity is 50-70%, and the lubricating liquid is perfluoropolyether oil. In order to improve the anti-fouling performance of the device, an ultra-smooth surface inspired by Nepenthes is constructed on the inner side of the anastomotic protective coating 9, which is composed of lubricating liquid and porous nano-array. By infusing various types of lubricating liquids into the micro-nano structure, a smooth, continuous and chemically uniform liquid-liquid surface is obtained. This surface can not be infiltrated by most liquids and presents a very small contact angle recession angle. The oil film on the surface significantly reduces the roughness of the substrate surface and reduces the friction when in contact with external forces. At the same time, the dynamic liquid self-repairing layer on the surface greatly improves its service life. In specific applications, this ultra-smooth surface can reduce the friction between the anastomotic protective coating 9 and the intestinal contents, prevent adhesion, and is easy to remove.

[0042] Example 2 A manufacturing process of a flexible inflatable protection device for intestinal anastomosis protection: (1) Material selection: Flexible polyurethane material is used as the main material of the inflatable skeleton structure 1 to ensure its inflation performance and volume reduction after collapse. The anastomotic stoma protective coating 9 with double bionic nanoarray is made of polytetrafluoroethylene material, which has anti-fouling performance. The remaining intake duct 6, intake valve 7 and exhaust valve 8 are all made of polyethylene material, which takes into account both mechanical properties and flexibility.

[0043] (2) Production and molding: a) A blow molding process is used to manufacture an inflatable skeleton with a transverse multi-layer C-shaped structure connected by longitudinal air channels 2, which has a total of 2 longitudinal air channels 2 and 4 layers of transverse C-shaped airbags 3, with a length of 6 cm and an inner diameter of 2 cm.

[0044] b) A polytetrafluoroethylene anastomotic protective coating 9 with a thickness of 80 μm is prepared by a film-forming process, and is cut to match the shape of the inflatable skeleton structure 1 .

[0045] c) The templates of the double bionic nanoarrays are prepared respectively by nanolithography technology, and then the surface of the anastomotic stoma protective film 9 is subjected to hot embossing treatment.

[0046] The template is prepared by nanolithography technology. For the gecko-inspired microciliary nanoarray structure on the outside of the anastomotic protective film 9, the size of each cilium obtained by the template is about 30-130μm, and the ends of the cilia are forked to form hundreds of smaller shovel-shaped villi, each of which is 100-300nm long and about 5nm thick.

[0047] The porous nano-array structure inspired by the pitcher plant on the inner side of the anastomotic protective film 9 has a pore size of about 100 nm and a porosity of about 66%. The interior and gaps of the porous nano-array structure are filled with a lubricant, which is perfluoropolyether oil.

[0048] d) The intake duct 6, the intake valve 7 and the exhaust valve 8 are manufactured by injection molding.

[0049] e) Assembling the above structures together by thermal welding.

[0050] Example 3 Insertion and removal of the flexible inflatable protective device: (1) Placement into the intestine: The uninflated flexible inflatable protection device is guided to the patient's intestinal anastomosis through a colonoscope, ensuring that the two ends of the device are placed at the upstream and downstream positions of the anastomosis respectively, so as to form effective support and protection after inflation.

[0051] (2) Inflation: a) Use the air inlet tube 6 to connect to an external air pump and slowly inflate the inflatable skeleton structure 1 to gradually expand it to a desired size. During the inflation process, the internal pressure should be monitored to ensure that the inflatable skeleton structure 1 provides sufficient support without causing excessive pressure on the intestine.

[0052] b) After inflation is completed, check whether the air inlet valve 7 is operating normally to ensure that the gas does not flow back and maintain the stability of the inflatable skeleton structure 1.

[0053] (3) Functional implementation: a) After the inflatable skeleton structure 1 expands, it drives the outer anastomotic protective coating 9 to expand to form a cylindrical structure with two openings at both ends and a hollow interior. The two end portions of the inflatable skeleton structure 1 are respectively tightly sealed with the intestinal inner walls upstream and downstream of the anastomosis and provide support force, thereby helping the anastomosis to resist mechanical stress. One side of the anastomotic protective coating 9 is in contact with the intestinal wall to play a further sealing and protective role. The internal hollow structure is used to drain the intestinal contents to prevent postoperative infection and anastomotic leakage.

[0054] b) The anastomotic stoma protection film 9 with double bionic nanoarrays is tightly attached to the anastomosis, providing an additional layer of protection to further prevent postoperative infection and anastomotic leakage.

[0055] c) The rough outer surface increases the compressive stress and friction between the intestinal wall, ensuring that the device will not move or fall off during use.

[0056] (4) Take out as needed: After use, the exhaust valve 8 is deflated through colonoscopy to collapse the inflatable skeleton structure 1 and drive the outer anastomotic protection film 9 to shrink. The shrunken flexible inflatable protection device is separated from the intestinal wall for direct removal, which can be discharged by the patient later.

[0057] Although embodiments of the present invention have been shown and described, it will be appreciated by those skilled in the art that various changes, modifications, substitutions and variations may be made to the embodiments without departing from the principles and spirit of the present invention, and that the scope of the present invention is defined by the appended claims and their equivalents.

Claims

1. A flexible inflatable protection device for intestinal anastomosis protection, characterized in that: It includes an inflatable skeleton structure, an air intake duct, an air intake valve, an air exhaust valve and an anastomotic stoma protective film; The inflatable skeleton structure is an internal hollow structure, an air inlet and an air outlet are provided on the inflatable skeleton structure, the air inlet duct is connected to the air inlet, an air inlet valve is installed at the connection between the air inlet and the air inlet duct, an air outlet valve is installed at the air outlet, and the outer side of the inflatable skeleton structure is covered with an anastomotic protective film; The inflatable skeleton structure is inflated and expands, driving the outer anastomotic protective film to expand to form a cylindrical structure with openings at both ends and a hollow interior. The openings at both ends of the inflatable skeleton structure after expansion are respectively in contact with the upper and lower inner walls of the anastomosis to form a supporting sealing structure. The inflatable skeleton structure is deflated and collapses, driving the outer anastomotic protective film to shrink. The openings at both ends of the inflatable skeleton structure after shrinkage are respectively separated from the upper and lower inner walls of the anastomosis to be removed.

2. The flexible inflatable protection device for intestinal anastomosis protection according to claim 1, characterized in that: The inflatable skeleton structure includes at least two longitudinal airways and multiple transverse C-shaped airbags. The longitudinal airways are arranged longitudinally side by side. The outer sides of the two ends of the longitudinal airways are respectively connected by at least two transverse C-shaped airbags. The adjacent transverse C-shaped airbags located at one end of the longitudinal airway are staggered up and down.

3. The flexible inflatable protection device for intestinal anastomosis protection according to claim 2, characterized in that: The inflatable skeleton structure comprises two longitudinal air passages and four transverse C-shaped air bags, and the outer sides of both ends of the longitudinal air passages are respectively connected to two transverse C-shaped air bags which are staggered up and down.

4. The flexible inflatable protection device for intestinal anastomosis protection according to claim 1, characterized in that: The inflatable skeleton structure is made of polyurethane, and the anastomotic protective film is made of polytetrafluoroethylene.

5. The flexible inflatable protection device for intestinal anastomosis protection according to any one of claims 1 to 4, characterized in that: The outer sides of the anastomotic stoma protection coating and the inflatable skeleton structure are rough structures, and a microciliary nano array structure is formed on the outer side of the anastomotic stoma protection coating.

6. The flexible inflatable protection device for intestinal anastomosis protection according to claim 5, characterized in that: The microciliary nanoarray structure includes a uniformly distributed ciliary structure formed on the outside of the anastomotic protective covering by nanolithography technology, and the end of each cilium is forked to form a plurality of shovel-shaped villi.

7. The flexible inflatable protection device for intestinal anastomosis protection according to claim 6, characterized in that: The length of cilia is 30-130 μm, and the length of spatula-shaped villi is 100-300 nm.

8. The flexible inflatable protection device for intestinal anastomosis protection according to claim 5, characterized in that: A porous nano-array structure is formed inside the anastomotic stoma protection film, and the interior and gaps of the porous nano-array structure are filled with lubricating liquid.

9. The flexible inflatable protection device for intestinal anastomosis protection according to claim 8, characterized in that: The average pore size of the porous nano-array structure is 50-200 nm, the porosity is 50-70%, and the lubricating fluid is perfluoropolyether oil.

10. The flexible inflatable protection device for intestinal anastomosis protection according to claim 1, characterized in that: The air intake valve is an air intake check valve, and the exhaust valve is a pin-type structure valve triggered by an external force.

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