A flexible inflatable protection device for intestinal anastomosis protection

Abstract

The invention discloses a flexible inflatable protective device for intestinal anastomosis protection, including an inflatable skeleton structure, an air inlet and an air outlet are provided on the inflatable skeleton structure, an 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 an anastomosis protective film is coated on the outside of the inflatable skeleton structure; the inflatable skeleton structure is inflated and expands to drive the outer anastomosis 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, and the inflatable skeleton structure is deflated and collapsed to separate from the upper and lower inner walls of the anastomosis for removal. The flexible inflatable protective device has a simple structural design, is easy to use, has strong applicability, can be inserted and removed non-invasively, effectively performs intestinal anastomosis postoperative protection, and reduces the incidence of complications.

Description

Technical Field

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

[0002] Intestinal anastomosis is very important in the treatment of various digestive system diseases. For example, chronic inflammatory bowel disease often causes intestinal stenosis or perforation, and intestinal tumors resection results in gaps, all of which require anastomosis of the affected intestinal segments. However, various complications and adverse reactions may occur after intestinal anastomosis, including anastomotic leakage, anastomotic stricture, infection, etc. Anastomotic leakage is one of the most serious complications, which may lead to severe infection and peritonitis. The risk of infection is also relatively high after intestinal anastomosis, especially at the surgical site. Anastomotic stricture may cause 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 the hospital stay, but also increase the patient's pain and medical costs.

[0003] In order to protect the anastomotic site after intestinal anastomosis, prophylactic stoma is commonly used clinically to divert intestinal contents. This method creates a stoma on the intestine to drain intestinal contents into an external collection bag, thus not affecting the anastomotic site. However, this will bring additional trauma and inconvenience to the patient, because the patient needs to adapt to the use and care of the ostomy bag. Therefore, there is an urgent need for a new device for post-operative protection of intestinal anastomosis to reduce the incidence of complications. Summary of the Invention

[0004] In order to solve the problem that various adverse complications are likely to occur in the existing intestinal anastomosis and postoperative protection is required, while the existing prophylactic stoma means will bring 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, can be inserted and removed non-invasively, effectively protects the intestinal anastomosis postoperatively, and reduces the incidence of complications.

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

[0006] The present invention provides a flexible inflatable protection device for intestinal anastomosis protection, including an inflatable skeleton structure, an air inlet catheter, an air inlet valve, an air outlet valve, and an anastomotic site protection film;

[0007] The inflatable skeleton structure is a hollow structure inside. The inflatable skeleton structure is provided with an air inlet and an air outlet. The air inlet catheter is communicated with the air inlet. An air inlet valve is installed at the connection between the air inlet and the air inlet catheter. An air outlet valve is installed at the air outlet. The outside of the inflatable skeleton structure is covered with an anastomotic site protection film;

[0008] The inflatable framework structure inflates and drives the anastomotic orifice protection film outside to expand, forming a cylindrical structure with both ends open and hollow inside. At both ends of the inflated inflatable framework structure, they are in contact with the inner walls on the upper and lower sides of the anastomotic orifice respectively to form a support and sealing structure. When the inflatable framework structure deflates and collapses, it drives the anastomotic orifice protection film outside to contract. At both ends of the contracted inflatable framework structure, they are separated from the inner walls on the upper and lower sides of the anastomotic orifice respectively for removal.

[0009] Adopting the above technical solution:

[0010] Taking the inflatable framework structure as the main body, with an anastomotic orifice protection film covering the outside. After inflation, the inflatable framework structure inflates and drives the anastomotic orifice protection film outside to expand, forming a cylindrical structure with both ends open and hollow inside. The two ends of the inflatable framework structure are closely attached and sealed to the inner intestinal walls upstream and downstream of the anastomotic orifice respectively, and provide a supporting force, thereby assisting the anastomotic orifice to resist mechanical stress. One side of the anastomotic orifice protection film fits the intestinal wall, playing a further role in sealing and protection. The internal hollow structure is used for draining intestinal contents, preventing postoperative infection and anastomotic leakage; after deflation, the inflatable framework structure collapses and drives the anastomotic orifice protection film outside to contract. The contracted flexible inflatable protection device is separated from the inner intestinal wall, facilitating direct removal, and then the patient can expel it by themselves.

[0011] Furthermore, the inflatable framework structure includes at least two longitudinal air channels and a plurality of transverse C-shaped air bags. The longitudinal air channels are arranged side by side longitudinally. The two outer ends of the longitudinal air channels are respectively connected by at least two transverse C-shaped air bags. The adjacent transverse C-shaped air bags at one end of the longitudinal air channel are arranged up and down staggeredly.

[0012] When designing the inflatable framework structure, it is necessary to be able to provide sufficient supporting force after inflation, thereby assisting the anastomotic orifice to resist mechanical stress, and at the same time collapse after deflation, facilitating direct removal. To achieve the above functions, the inflatable framework structure is specifically designed. It consists of a plurality of longitudinal air channels arranged side by side longitudinally. The two ends of the plurality of longitudinal air channels are respectively connected by a plurality of transverse C-shaped air bags. Moreover, the transverse C-shaped air bags are connected and integrated with the internal channels of the longitudinal air channels, facilitating the inflation and deflation operations of the inflatable framework structure. After inflation, the inflatable framework structure forms a structure with a hollow inside and both ends open, which is used for draining intestinal contents. Moreover, at both ends, larger openings are formed by the transverse C-shaped air bags arranged up and down staggeredly, and sufficient supporting force is provided, closely attaching to the intestinal wall to form multiple seals, which is beneficial for collecting intestinal contents and reducing overflow.

[0013] Furthermore, the inflatable framework structure includes two longitudinal air channels and four transverse C-shaped air bags. The two outer ends of the longitudinal air channels are respectively connected with two transverse C-shaped air bags arranged up and down staggeredly.

[0014] Since this product is specifically applied to the intestinal anastomosis site after intestinal anastomosis, the size of the inflated inflatable skeleton structure needs to match the size of the intestinal wall at the intestinal anastomosis site and be able to provide sufficient support and protection force. Preferably, an inflatable skeleton structure with a transverse multi-layer C-shaped airbag structure connected by longitudinal air ducts is adopted, which has a total of 2 longitudinal air ducts and 4 layers of C-shaped airbags, with a length of 6 cm and an inner diameter of 2 cm for the C-shaped airbags.

[0015] Furthermore, the inflatable skeleton structure is made of polyurethane material, and the anastomosis protection film is made of polytetrafluoroethylene material.

[0016] The inflatable skeleton structure is made of a flexible and durable polyurethane material, which can provide sufficient support force after inflation, thus assisting the anastomosis to resist mechanical stress, and at the same time collapsing after deflation, facilitating direct removal. The anastomosis protection film covers the surface of the inflatable skeleton structure, closely adheres to the anastomosis, provides an additional protective layer, and prevents postoperative infection and anastomotic leakage. The anastomosis protection film uses polytetrafluoroethylene material, which has good biocompatibility and anti-fouling performance. The air inlet catheter is made of polyethylene material, which is flexible and pressure-resistant, thus ensuring smooth gas flow. It connects the inflatable skeleton structure and an external air pump, and is used to transport gas into the inflatable skeleton structure.

[0017] Furthermore, the outer sides of the anastomosis protection film and the inflatable skeleton structure are rough structures, and a microciliated nanoarray structure is formed on the outer side of the anastomosis protection film.

[0018] The intestine has continuous peristalsis and material flow, which poses severe requirements for the fixation ability and anti-fouling performance of intestinal medical devices. In the present invention, by designing the outer sides of the anastomosis protection film and the inflatable skeleton structure as rough structures, the flexible inflatable protection device is fixed around the anastomosis to ensure that it will not move or fall off during use, increasing the compressive stress and friction force with the intestinal wall, and ensuring the stability and reliability of the device.

[0019] Preferably, a bionic nanoarray is constructed on the outer side of the anastomosis protection film. Specifically, the gecko-inspired microciliated nanoarray mimics the microstructures on the gecko's foot. These microstructures play a key role in adhesion, can form reliable contacts on various surfaces and accumulate van der Waals forces, generating strong adhesion force. When specifically applied, the outer side of the anastomosis protection film closely adheres to the intestinal wall, and the surface has a microciliated nanoarray structure, providing abundant friction force, thus firmly fixing with the intestinal wall.

[0020] Furthermore, the microciliated nanoarray structure includes cilia structures evenly distributed on the outer side of the anastomosis protection film formed by nano-lithography technology, and the end of each cilium bifurcates to form multiple spatula-shaped villi.

[0021] Furthermore, the length of cilia is 30-130 μm, and the length of spade-shaped villi is 100-300 nm.

[0022] 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.

[0023] 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.

[0024] 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.

[0025] Furthermore, the intake valve is an intake check valve, and the exhaust valve is a pin-type structure valve triggered by an external force.

[0026] 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.

[0027] 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.

[0028] Compared with the prior art, the present invention has the following beneficial effects:

[0029] 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.

[0030] 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.

[0031] 3. Non-invasive insertion and removal: The flexible inflatable protection device can be inflated after being inserted into the intestine, and then form a protective support. When it needs to be removed, it can be deflated through colonoscopy operation to make it collapse, and the patient can expel it by himself.

[0032] 4. Reduce the difficulty of postoperative care: Due to the simple design of the device, compared with traditional stomas, patients do not need to perform complex operations during postoperative care, reducing the difficulty and time of care.

[0033] 5. Strong adaptability: The inflation degree and position of the device can be adjusted. The adjustable design enables it to adapt to the anatomical structures and surgical needs of different patients, providing personalized protection effects.

[0034] 6. Reduce medical costs: By reducing postoperative complications and shortening the hospital stay, it can effectively reduce the medical costs of patients and improve the utilization efficiency of medical resources.

[0035] 7. Multiple bionic functionalized design: One side of the anastomosis protection film adheres closely to the intestinal wall, and the surface has a microciliated nanoarray structure inspired by geckos, providing abundant friction, so as to be firmly fixed to the intestinal wall. The other side of the anastomosis protection film is inspired by Nepenthes, and has a super-smooth surface composed of lubricating fluid and porous nanoarray, endowing the medical device with good anti-fouling performance and anti-adhesion ability. BRIEF DESCRIPTION OF THE DRAWINGS

[0036] The present invention will be further described in detail below with reference to the accompanying drawings and specific embodiments.

[0037] Figure 1 It is a schematic diagram of the overall structure of the flexible inflatable protection device in the present invention;

[0038] Figure 2 It is a schematic diagram of the structure of the inflatable skeleton structure in the present invention;

[0039] Figure 3 It is a schematic diagram of the connection state of the air inlet conduit and the air inlet valve in the present invention;

[0040] Figure 4 It is a schematic diagram of the structure of the exhaust valve in the present invention;

[0041] Figure 5 It is a schematic diagram of the flexible inflatable protection device placed at the anastomosis after intestinal anastomosis and inflated;

[0042] Figure 6 It is a scanning electron micrograph of the physical object of the porous nanoarray structure on the inner side of the anastomosis protection film in the present invention;

[0043] Figure 7This is a three-dimensional modeling diagram of the microciliated nanoarray structure on the outer side of the anastomosis protection film in the present invention;

[0044] Among them, the specific reference numerals are as follows:

[0045] Inflatable skeleton structure 1, longitudinal air duct 2, transverse C-shaped airbag 3, air inlet 4, exhaust port 5, air inlet conduit 6, air inlet valve 7, exhaust valve 8, anastomosis protection film 9. Specific embodiments

[0046] Next, the technical solutions in the embodiments of the present invention will be clearly and completely described in conjunction with 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 the embodiments. Based on the embodiments of the present invention, all other embodiments obtained by those of ordinary skill in the art without making creative efforts shall fall within the protection scope of the present invention.

[0047] Example 1

[0048] A flexible inflatable protection device for intestinal anastomosis protection, as Figures 1 to 5 shown, includes an inflatable skeleton structure 1, an air inlet conduit 6, an air inlet valve 7, an exhaust valve 8, and an anastomosis protection film 9; the inflatable skeleton structure 1 is a hollow structure inside, and an air inlet 4 and an exhaust port 5 are provided on the inflatable skeleton structure 1. The air inlet conduit 6 is communicated with the air inlet 4, and an air inlet valve 7 is installed at the connection between the air inlet 4 and the air inlet conduit 6, and an exhaust valve 8 is installed at the exhaust port 5. The outer side of the inflatable skeleton structure 1 is covered with an anastomosis protection film 9; the inflatable skeleton structure 1 inflates and expands to drive the anastomosis protection film 9 on the outside to expand and form a cylindrical structure with both ends open and hollow inside. The two open ends of the inflated inflatable skeleton structure 1 are respectively in contact with the inner walls on the upper and lower sides of the anastomosis to form a support and sealing structure. The inflatable skeleton structure 1 deflates and collapses to drive the anastomosis protection film 9 on the outside to contract, and the two open ends of the contracted inflatable skeleton structure 1 are respectively separated from the inner walls on the upper and lower sides of the anastomosis for removal. Taking the inflatable skeleton structure 1 as the main body, with an anastomosis protection film 9 covered on the outside, after inflation, the inflatable skeleton structure 1 inflates and expands to drive the anastomosis protection film 9 on the outside to expand and form a cylindrical structure with both ends open and hollow inside. The two end parts of the inflatable skeleton structure 1 are respectively closely attached and sealed to the intestinal inner walls upstream and downstream of the anastomosis, and provide a supporting force, thereby assisting the anastomosis to resist mechanical stress. One side of the anastomosis protection film 9 is attached to the intestinal wall to play a further sealing and protection role. The hollow structure inside is used for draining intestinal contents to prevent postoperative infection and anastomotic leakage; after deflation, the inflatable skeleton structure 1 collapses and drives the anastomosis protection film 9 on the outside to contract, and the contracted flexible inflatable protection device is separated from the intestinal inner wall, facilitating direct removal, and then the patient can expel it by himself.

[0049] Among them, the inflatable skeleton structure 1 includes at least two longitudinal air channels 2 and a plurality of transverse C-shaped airbags 3. The longitudinal air channels 2 are arranged longitudinally side by side, and the outer sides of both ends of the longitudinal air channels 2 are respectively connected by at least two transverse C-shaped airbags 3. The adjacent transverse C-shaped airbags 3 at one end of the longitudinal air channel 2 are arranged vertically staggered. When designing the inflatable skeleton structure 1, it is necessary to be able to provide sufficient supporting force after inflation, so as to assist the anastomotic stoma to resist mechanical stress, and at the same time collapse after deflation, which is convenient for direct removal. In order to achieve the above functions, the inflatable skeleton structure 1 is specifically designed. It is composed of a plurality of longitudinal air channels 2 arranged longitudinally side by side. Both ends of the plurality of longitudinal air channels 2 are respectively connected by a plurality of transverse C-shaped airbags 3, and the transverse C-shaped airbags 3 are communicated with the internal channels of the longitudinal air channels 2 as a whole, which is convenient for inflating and deflating the inflatable skeleton structure 1. After inflation, the inflatable skeleton structure 1 forms a structure with a hollow interior and open ends, which is used for draining intestinal contents. Moreover, larger openings are formed at both ends by the vertically staggered transverse C-shaped airbags 3, and sufficient supporting force is provided to closely adhere to the intestinal wall to form multiple seals, which is beneficial to collecting intestinal contents and reducing spillage.

[0050] In a specific embodiment, the inflatable skeleton structure 1 includes two longitudinal air channels 2 and four transverse C-shaped airbags 3. Two vertically staggered transverse C-shaped airbags 3 are respectively connected to the outer sides of both ends of the longitudinal air channels 2. Since this product is specifically applied to the intestinal anastomotic stoma after intestinal anastomosis, therefore, the size of the inflatable skeleton structure 1 after inflation needs to match the size of the intestinal wall at the intestinal anastomotic stoma and be able to provide sufficient supporting and protective force. Preferably, the inflatable skeleton structure 1 with a multi-layer C-shaped airbag structure in the transverse direction connected by the longitudinal air channels 2 is adopted, which has a total of 2 longitudinal air channels 2 and 4 layers of airbags, with a length of 6 cm and an inner diameter of the C-shaped airbag of 2 cm.

[0051] Among them, the inflatable skeleton structure 1 is made of flexible and durable polyurethane material, which can provide sufficient supporting force after inflation, so as to assist the anastomotic stoma to resist mechanical stress, and at the same time collapse after deflation, which is convenient for direct removal. The anastomotic stoma protection film 9 covers the surface of the inflatable skeleton structure 1, closely adheres to the anastomotic stoma, provides an additional protective layer to prevent postoperative infection and anastomotic leakage. The anastomotic stoma protection film 9 uses polytetrafluoroethylene material, which has good biocompatibility and anti-fouling performance. The air inlet catheter 6 is made of polyethylene material, which is flexible and pressure-resistant in texture, so as to ensure the smooth flow of gas. It connects the inflatable skeleton structure 1 and an external air pump, and is used to transport gas into the inflatable skeleton structure 1.

[0052] 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.

[0053] 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.

[0054] 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.

[0055] Among them, Figure 6As shown, a porous nanoarray structure is formed inside the anastomosis protection film 9, and the lubricating fluid is filled inside and in the gaps of the porous nanoarray structure. The average pore diameter of the porous nanoarray structure is 50-200 nm, and the porosity is 50-70%. The lubricating fluid is perfluoropolyether oil. In order to improve the anti-fouling performance of the device, a super-smooth surface inspired by Nepenthes and composed of a lubricating fluid and a porous nanoarray is constructed on the inner side of the anastomosis protection film 9. By pouring various lubricating fluids into the micro-nano structure, a smooth, continuous and chemically homogeneous liquid-liquid surface is obtained. This surface cannot be wetted by the vast majority of liquids, showing a very small contact angle receding angle. The oil film on the surface significantly reduces the roughness of the substrate surface and reduces the friction when contacting with external forces. At the same time, the dynamic liquid self-repair layer of this surface greatly improves its service life. In specific applications, this super-smooth surface can reduce the friction between the anastomosis protection film 9 and the intestinal contents, prevent adhesion, and is easy to remove.

[0056] Example 2

[0057] Manufacturing process of a flexible inflatable protection device for intestinal anastomosis protection:

[0058] (1) Material selection:

[0059] A flexible polyurethane material is used as the main material of the inflatable skeleton structure 1 to ensure its inflatable expandable performance and volume reduction after collapse. The anastomosis protection film 9 with a dual bionic nanoarray uses polytetrafluoroethylene material, which has anti-fouling performance. The remaining air inlet conduit 6, air inlet valve 7 and exhaust valve 8 are all made of polyethylene material, taking into account mechanical properties and flexibility.

[0060] (2) Manufacturing and forming:

[0061] a) An inflatable skeleton with a transverse multi-layer C-shaped structure connected by a longitudinal airway 2 is manufactured through a blow molding process. It has a total of 2 longitudinal airways 2 and 4 layers of transverse C-shaped airbags 3, with a length of 6 cm and an inner diameter of 2 cm for the transverse C-shaped airbags 3.

[0062] b) The anastomosis protection film 9 made of polytetrafluoroethylene material with a thickness of 80 μm is prepared through a film-forming process and cut to match the shape of the inflatable skeleton structure 1.

[0063] c) Templates of dual bionic nanoarrays are respectively prepared through nano-lithography technology, and then the surface of the anastomosis protection film 9 is subjected to hot embossing treatment.

[0064] 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.

[0065] 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.

[0066] d) The intake duct 6, the intake valve 7 and the exhaust valve 8 are manufactured by injection molding.

[0067] e) Assembling the above structures together by thermal welding.

[0068] Example 3

[0069] Insertion and removal of the flexible inflatable protective device:

[0070] (1) Placement into the intestine:

[0071] 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.

[0072] (2) Inflation:

[0073] 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.

[0074] 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.

[0075] (3) Functional implementation:

[0076] 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.

[0077] b) The anastomosis protection film 9 with a dual bionic nanoarray closely adheres to the anastomosis, providing an additional protective layer to further prevent postoperative infection and anastomotic leakage.

[0078] c) The rough outer surface ensures that the device does not move or fall off during use by increasing the compressive stress and friction force between the intestinal wall.

[0079] (4) Removal as needed:

[0080] After use, the exhaust valve 8 is deflated through colonoscopy operation, causing the inflatable skeleton structure 1 to collapse and driving the contraction of the outer anastomosis protection film 9. The contracted flexible inflatable protection device separates from the inner wall of the intestine, facilitating direct removal, and the patient can then expel it on their own.

[0081] 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 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 stoma 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 anastomotic stoma to form a supporting sealing structure. The inflatable skeleton structure is deflated and collapses, driving the outer anastomotic stoma 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 anastomotic stoma for removal. The inflatable skeleton structure comprises two longitudinal airways and four transverse C-shaped airbags. The longitudinal airways are longitudinally arranged side by side, and the outer sides of both ends of the longitudinal airway are respectively connected to two transverse C-shaped airbags arranged in an up-and-down staggered manner.

2. 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.

3. The flexible inflatable protection device for intestinal anastomosis protection according to claim 1 or 2, 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.

4. The flexible inflatable protection device for intestinal anastomosis protection according to claim 3, 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.

5. The flexible inflatable protection device for intestinal anastomosis protection according to claim 4, characterized in that: The length of cilia is 30-130 μm, and the length of spatula-shaped villi is 100-300 nm.

6. The flexible inflatable protection device for intestinal anastomosis protection according to claim 3, 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.

7. The flexible inflatable protection device for intestinal anastomosis protection according to claim 6, 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 liquid is perfluoropolyether oil.

8. 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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