Colorectal anastomosis protecting device and colorectal anastomosis protecting method

Abstract

The application discloses a kind of colorectal anastomosis protection device and the protection method of colorectal anastomosis, it is related to medical instrument technical field, wherein, the colorectal anastomosis protection device includes: annular balloon, with inflation port, the inflation port is connected to charge and discharge gas pipeline;Protective sheath is connected with annular balloon, the center passage of the protective sheath one end is communicated with the center hole of annular balloon, the other end extends towards the direction away from annular balloon;Support frame is supported on the inner wall of the center hole of annular balloon, and the flexibility of the support frame is less than the flexibility of annular balloon.The technical scheme of the present application, by setting support frame on the inner wall of the center hole of balloon, the inner wall of the center hole of balloon is supported, so that the center hole of balloon after inflation can be avoided too small, ensure that the contents in colorectal can pass smoothly.

Description

Technical Field

[0001] This invention relates to the field of medical device technology, specifically to a colorectal anastomosis protection device and a method for protecting the colorectal anastomosis. Background Technology

[0002] After colorectal surgery, the preservation of the anastomosis is crucial to the success of the surgery and the quality of recovery. Poor anastomotic healing can lead to serious complications such as anastomotic leakage, bleeding, or stenosis.

[0003] Chinese patent document CN208989282U discloses a digestive tract isolation protective sleeve for protecting anastomoses in the intestine. Specifically, it includes a circular balloon and a flexible sleeve fixedly disposed on the lower surface of the balloon. The central hole of the circular balloon communicates with the inner cavity of the flexible sleeve. The balloon also has a trachea for inflating and deflating the balloon. In use, the balloon is inflated using an air source. The inflated balloon is fixed to the inner wall of the intestine above the anastomosis. The contents of the intestine are discharged from the body through the central hole of the circular balloon and the inner cavity of the flexible sleeve. The flexible sleeve then isolates the contents of the intestine from the anastomosis, effectively preventing anastomotic leakage.

[0004] However, with the above method, after the balloon is inflated, the inner ring of the balloon makes the central hole smaller. If the diameter of the central hole is too small when protecting the colorectal anastomosis, it will be impossible to guarantee the passage of contents in the colorectum. Summary of the Invention

[0005] In view of this, the present invention provides a colorectal anastomosis protection device and a method for protecting the colorectal anastomosis, so as to solve the problem that the contents of the colorectum cannot be guaranteed to pass through after the balloon is inflated.

[0006] This invention provides a colorectal anastomosis protection device, comprising: An annular balloon has an inflation port connected to an inflation / deflation pipe. A protective sleeve is connected to the annular balloon. One end of the central channel of the protective sleeve is connected to the central hole of the annular balloon, and the other end extends away from the annular balloon. A support frame is provided on the inner wall of the central hole of the annular balloon, and the flexibility of the support frame is less than that of the annular balloon.

[0007] The technical solution of this invention provides a support frame on the inner wall of the central hole of the balloon, thereby supporting the inner wall of the central hole of the balloon and preventing the central hole of the balloon from being too small after inflation, thus ensuring that the contents of the colon and rectum can pass through smoothly.

[0008] Optionally, a pressure sensor and a gas filling / discharging control unit are connected to the gas filling / discharging pipeline. The pressure sensor is connected to the controller, and the controller is connected to the gas filling / discharging control unit.

[0009] Optionally, the inflation / deflation control unit includes an inflation device and an electrically controlled valve connected to the inflation / deflation pipeline.

[0010] Optionally, the electrically controlled valve includes an inflation valve and an venting valve.

[0011] Optionally, the outer wall of the annular balloon is provided with an anti-slip structure.

[0012] Optionally, the outer wall of the annular balloon has a wavy anti-slip structure.

[0013] Optionally, the support frame is a mesh support woven from shape memory metal.

[0014] Optionally, the support frame is made of a developing material.

[0015] The present invention also provides a method for protecting a colorectal anastomosis, comprising the following steps: The colorectal anastomosis protection device described in any of the above schemes is inserted above the anastomosis of the colorectum, so that the protective sleeve is located at the anastomosis. The circular balloon is inflated so that its outer wall fits against the inner wall of the colon and rectum, and the support frame is stretched open on the inner wall of the central hole of the circular balloon.

[0016] Optionally, a pressure sensor and a gas filling / discharging control unit are connected to the gas filling / discharging pipeline. The pressure sensor is connected to a controller, and the controller is connected to the gas filling / discharging control unit. When the contents of the colon and rectum pass through, the controller controls the inflation / deflation control unit to increase the pressure of the annular balloon. After the contents of the colon and rectum pass through, the controller controls the inflation / deflation control unit to decrease the pressure of the annular balloon.

[0017] The technical solution of this invention provides direct protection for the anastomosis by accurately placing the protective device above the anastomosis and positioning the protective sleeve at the anastomosis site. After inflation, the circular balloon adheres to the inner wall of the colon and rectum, providing even support to the intestine, reducing pressure at the anastomosis site, lowering the risk of anastomotic dehiscence due to intestinal peristalsis and changes in intraluminal pressure, and promoting anastomotic healing.

[0018] The support frame expands within the central hole of the circular balloon to prevent the central hole from becoming too small after inflation, ensuring that contents of the colon and rectum, such as feces and digestive juices, can pass through smoothly, maintaining normal intestinal excretion function, and preventing a series of complications caused by intestinal obstruction, such as intestinal obstruction and infection. Attached Figure Description

[0019] To more clearly illustrate the specific embodiments of the present invention or the technical solutions in the prior art, the drawings used in the description of the specific embodiments or the prior art will be briefly introduced below. Obviously, the drawings described below are some embodiments of the present invention. For those skilled in the art, other drawings can be obtained from these drawings without creative effort.

[0020] Figure 1 This is a schematic diagram of a colorectal anastomosis protection device before it is packed into the colorectum, according to an embodiment of the present invention. Figure 2 for Figure 1 The diagram shows the colorectal anastomosis protection device after it has been inserted above the colorectal anastomosis. Figure 3 for Figure 2 A schematic diagram showing the contents of the internal structure of the colorectal anastomosis protection device. Figure 4 for Figure 2 A schematic diagram of the internal structure of the colorectal anastomosis protection device shown in the figure; Figure 5 This is a schematic diagram of the inflation / deflation control unit of a colorectal anastomosis protection device provided in an embodiment of the present invention.

[0021] Explanation of reference numerals in the attached figures 1. Circular balloon; 2. Inflation / depression tubing; 3. Protective sleeve; 4. Support frame; 5. Pressure sensor; 6. Inflation device; 7. Inflation valve; 8. Depression valve; 9. Colon and rectum; 10. Anastomosis. Detailed Implementation

[0022] To make the objectives, technical solutions, and advantages of the embodiments of the present invention clearer, the technical solutions of the embodiments of the present invention will be clearly and completely described below with reference to the accompanying drawings. Obviously, the described embodiments are only some embodiments of the present invention, not all embodiments. Based on the embodiments of the present invention, all other embodiments obtained by those skilled in the art without creative effort are within the scope of protection of the present invention.

[0023] In the description of this invention, it should be noted that the terms "center," "upper," "lower," "left," "right," "vertical," "horizontal," "inner," and "outer," etc., indicate the orientation or positional relationship based on the orientation or positional relationship shown in the accompanying drawings. They are used only for the convenience of describing the invention and for simplifying the description, and do not indicate or imply that the device or element referred to must have a specific orientation, or be constructed and operated in a specific orientation. Therefore, they should not be construed as limitations on the invention. Furthermore, the terms "first," "second," and "third" are used for descriptive purposes only and should not be construed as indicating or implying relative importance.

[0024] In the description of this invention, it should be noted that, unless otherwise explicitly specified and limited, the terms "installation," "connection," and "joining" should be interpreted broadly. For example, they can refer to a fixed connection, a detachable connection, or an integral connection; they can refer to a direct connection or an indirect connection through an intermediate medium. Those skilled in the art can understand the specific meaning of the above terms in this invention according to the specific circumstances.

[0025] Furthermore, the technical features involved in the different embodiments of the present invention described below can be combined with each other as long as they do not conflict with each other.

[0026] Reference Figures 1-4 As shown, this is a specific implementation of the colorectal anastomosis protection device provided in this embodiment, which includes: an annular balloon 1, the annular balloon 1 having an inflation port, the inflation port being connected to an inflation / deflation pipe 2.

[0027] A protective sleeve 3 is connected to the annular balloon 1. One end of the central channel of the protective sleeve 3 is connected to the central hole of the annular balloon 1, and the other end extends away from the annular balloon 1.

[0028] A support frame 4 is provided on the inner wall of the central hole of the annular balloon 1. The flexibility of the support frame 4 is less than that of the annular balloon 1.

[0029] In this embodiment, a support frame 4 is provided on the inner wall of the central hole of the balloon to support the inner wall of the central hole of the balloon, thereby preventing the central hole of the balloon from being too small after inflation and ensuring that the contents of the colon and rectum 9 can pass through smoothly.

[0030] When the annular balloon 1 is inflated, due to its inherent flexibility, it expands and deforms under inflation pressure. Without the support frame 4, the central aperture of the balloon might become smaller or even blocked during inflation due to the contraction and deformation of the balloon material. The support frame 4, being less flexible than the annular balloon 1, provides stronger support and maintains the shape and size of the central aperture during balloon inflation. This allows contents of the colon and rectum 9, such as feces and digestive juices, to pass smoothly through the central aperture, ensuring normal intestinal excretion and reducing the risk of blockage due to an excessively small central aperture, thus mitigating potential complications such as infection and intestinal obstruction.

[0031] In some embodiments, the support frame 4 is also annular, reducing the area of ​​the balloon being squeezed towards the central hole after inflation. Alternatively, in some alternative embodiments, the support frame 4 can be several arc-shaped supports spaced or staggered around the central hole, similarly supporting the central hole and ensuring the passage of contents. It can also flexibly adapt to different intestinal conditions and pressure distributions. Although these arc-shaped support frames 4 are not continuous annular, they are distributed circumferentially around the central hole, each independently supporting the balloon wall at its location. The spaced arrangement provides a certain elasticity between the support frames 4, adapting to changes in local pressure during balloon inflation; the staggered arrangement more comprehensively distributes the supporting force, preventing the balloon from excessively squeezing towards the central hole in certain areas due to lack of support. Thus, overall, the central hole is not excessively reduced due to balloon inflation, allowing the contents of the colon and rectum to pass normally.

[0032] Additionally, it should be noted that in this embodiment, the flexibility of the support frame 4 does not mean that the support frame 4 itself is made of a flexible material, but rather that the support frame 4 as a whole is flexible. The material of the support frame 4 can be metal. By reasonably designing its structure, such as using a thinner metal sheet, designing a hollow or elastic structure, the support frame 4 can have a certain degree of flexibility as a whole. This flexibility allows the support frame 4 to undergo a certain degree of deformation when subjected to intestinal peristalsis or other external forces, while maintaining its supporting function for the central opening of the balloon and maintaining the passage space for the contents.

[0033] The technical solution provided in this embodiment uses a ring-shaped balloon 1 to support the intestinal wall. This ensures sufficient support pressure while preventing damage to the intestine. Furthermore, by adjusting the inflation of the ring-shaped balloon 1, the support pressure on the intestine can be adjusted in a timely manner, thus preventing problems such as excessive compression of the intestine leading to obstructed blood supply. Specifically, the material of the ring-shaped balloon 1 typically has good softness and elasticity. When in contact with the intestinal wall, it can conform to the irregular shape of the intestine, dispersing the pressure applied to the intestine. Compared to some rigid supports, the balloon surface makes surface contact with the intestinal wall, rather than point or line contact, reducing the pressure per unit area. This ensures sufficient support to maintain the intestinal shape while reducing the risk of mechanical damage to intestinal tissue.

[0034] The blood supply to the intestines depends on the unobstructed flow of blood vessels surrounding the intestines. Excessive external pressure applied to the intestines can compress these blood vessels, hindering blood circulation. The amount of gas inside the ring-shaped balloon 1 can be easily adjusted via the inflation / deflation tube 2, thereby changing the pressure of the balloon on the intestinal wall. Healthcare professionals can adjust the amount of gas inside the balloon as needed, based on the patient's physiological response and the real-time state of the intestines.

[0035] Reference Figure 5 As shown, in some embodiments, a pressure sensor 5 and an inflation / deflation control unit are connected to the inflation / deflation pipe 2. The pressure sensor 5 is connected to a controller, and the controller is connected to the inflation / deflation control unit. This configuration enables precise monitoring and automatic adjustment of the pressure inside the annular balloon 1, further ensuring appropriate support pressure for the intestine and effectively preventing damage to the intestine or impairment of normal intestinal function due to improper pressure. Specifically, the pressure sensor 5 is installed on the inflation / deflation pipe 2 and can sense changes in gas pressure inside the annular balloon 1 in real time. The pressure sensor 5 typically operates based on principles such as piezoresistive and piezoelectric effects. When the pressure inside the balloon changes, the sensor's resistance or charge changes accordingly, which is converted into an electrical signal output through a circuit. This electrical signal corresponds to the pressure value inside the balloon, thereby accurately measuring the pressure inside the balloon.

[0036] Pressure sensor 5 transmits the monitored pressure signal to the controller. The controller has a pre-set pressure range suitable for intestinal support and compares the received actual pressure signal with the preset range. If the actual pressure is lower than the preset lower limit, the controller sends an inflation command to the inflation / deflation control unit; if the actual pressure is higher than the preset upper limit, the controller sends a deflation command. After receiving the command, the inflation / deflation control unit controls the valves or air pumps on the inflation / deflation pipeline 2 to inflate or deflate the annular balloon 1, ensuring that the pressure inside the balloon is always maintained within a suitable range. For example, when intestinal peristalsis or other factors cause a temporary decrease in pressure inside the balloon, pressure sensor 5 quickly senses this and transmits the signal to the controller. The controller then instructs the inflation / deflation control unit to inflate the balloon in a timely manner to ensure stable support pressure for the intestine and prevent insufficient pressure from affecting the support effect. Conversely, if the pressure inside the balloon increases for some reason, the system can also respond in time to deflate the balloon to avoid excessive pressure compressing the intestine.

[0037] Reference Figure 5 As shown, in some embodiments, the inflation / deflation control unit includes an inflation device 6 and an electrically controlled valve connected to the inflation / deflation pipeline 2. This configuration allows for precise and convenient control of the inflation / deflation process of the annular balloon 1, thereby accurately adjusting the balloon's support pressure on the intestine and greatly improving the practicality and safety of the entire colorectal anastomosis protection device.

[0038] Inflation Principle: The inflation device 6 begins operation after receiving an inflation command from the controller. The inflation device 6 typically includes an air pump, which pumps outside air (or other suitable gas) into the annular balloon 1 through the inflation / deflation pipe 2. The air pump, driven by a motor, creates a pressure difference, causing gas to continuously enter the pipe and eventually inflate the balloon. As gas enters, the balloon gradually expands, applying supporting pressure to the intestinal wall. Specifically, during operation, when the controller determines that the pressure inside the balloon is lower than the preset suitable lower limit of support pressure, it sends a start signal to the inflation device 6. The air pump then starts operating, inflating the balloon with air and raising the balloon pressure to the appropriate range.

[0039] Deflator Principle: An electrically controlled valve is installed on the inflation / deflation pipe 2. When the controller issues a deflation command, the electrically controlled valve opens. Because the gas pressure inside the balloon is higher than the external atmospheric pressure, under the action of the pressure difference, the gas inside the balloon is discharged through the inflation / deflation pipe 2 and the opened electrically controlled valve, thereby reducing the pressure inside the balloon. Specifically, during operation, if the controller detects that the pressure inside the balloon is higher than the preset upper limit, it will send an opening signal to the electrically controlled valve. The valve opens, the gas inside the balloon is discharged, and the pressure decreases accordingly. This combination of the inflation device 6 and the electrically controlled valve achieves precise control of the amount of gas inside the balloon, thereby accurately adjusting the support pressure of the balloon on the intestine.

[0040] Reference Figure 5 As shown, in some embodiments, the electrically controlled valve includes an inflation valve 7 and a deflation valve 8. In the above scheme, the inflation and deflation functions are controlled by independent inflation valves 7 and deflation valves 8, enabling more precise operation of the inflation and deflation process of the annular balloon 1. This helps to accurately adjust the pressure inside the balloon, ensuring that its support pressure on the intestine is always within an appropriate range, minimizing the risk of damage to the intestine or impairing normal intestinal function due to improper pressure.

[0041] The independent valve design ensures that inflation and deflation operations do not interfere with each other. During inflation, the deflation valve 8 is closed to prevent gas leakage; during deflation, the inflation valve 7 is closed to prevent backflow of air. This design enhances the stability and reliability of the entire inflation and deflation system and reduces the possibility of pressure runaway due to valve failure.

[0042] Of course, the above description is not limiting. In some embodiments, a two-position three-way solenoid valve can be used instead of the inflation valve 7 and the deflation valve 8. The two-position three-way solenoid valve has three ports, which are respectively connected to the inflation device 6, the deflation port (leading to the outside), and the connection between the inflation / deflation pipeline 2 and the balloon. The solenoid valve controls the position of the valve core through electromagnetic force, realizing the connection and disconnection between the different ports. When inflation is required, the electromagnetic force moves the valve core, connecting the port of the inflation device 6 with the port of the inflation / deflation pipeline 2, and gas flows from the inflation device 6 into the balloon; when deflation is required, the electromagnetic force changes the position of the valve core, connecting the port of the inflation / deflation pipeline 2 with the deflation port, and the gas in the balloon is discharged. By controlling the energization state of the solenoid valve, inflation / deflation functions similar to those of the inflation valve 7 and the deflation valve 8 can be achieved. When using a two-position three-way solenoid valve, it has the advantages of high integration and relatively small size. It can simplify the connection structure of the inflation / deflation pipeline 2 and reduce system complexity. At the same time, its response speed is fast, and it can quickly realize the switching between inflation and deflation states. Of course, compared to the independent inflation valve 7 and deflation valve 8, a malfunction in a two-position three-way solenoid valve may affect both inflation and deflation functions simultaneously. Furthermore, the internal structure of the solenoid valve is relatively complex, making maintenance more difficult.

[0043] Reference Figures 2-4As shown, in some embodiments, the outer wall of the annular balloon 1 is provided with an anti-slip structure. The anti-slip structure effectively prevents the annular balloon 1 from shifting within the intestine, ensuring that the balloon remains in a critical position requiring support and protection, such as the anastomosis 10 of the colon and rectum 9. This allows it to continuously support the intestinal wall, ensuring the smooth passage of contents from the colon and rectum 9, while maintaining protection of the anastomosis 10 and reducing the risk of complications such as anastomosis 10 rupture due to balloon displacement. Specifically, the anti-slip structure alters the surface characteristics of the outer wall of the annular balloon 1. By increasing surface roughness or adopting a special shape design, the microscopic interaction force is enhanced when the balloon contacts the intestinal wall, thereby increasing friction. For example, when the anti-slip structure has raised textures, these textures can embed into the folds or irregular surfaces of the intestinal wall, forming a mechanical interlock and hindering the balloon from sliding relative to the intestinal wall. If the anti-slip structure uses a special rubber material, its high elasticity and viscosity can also increase adhesion to the intestinal wall, further preventing displacement.

[0044] Furthermore, the anti-slip structure increases the friction between the annular balloon 1 and the intestinal wall, allowing the balloon to adhere more closely to the intestinal wall. This more evenly distributes the support pressure, preventing localized pressure concentration from damaging intestinal tissue and further enhancing the stability and comfort of the support. Because the anti-slip structure ensures a tighter fit between the balloon and the intestinal wall, the support pressure is more evenly distributed across the intestinal wall. When the intestines move or are subjected to other external forces, the anti-slip structure helps to disperse these forces, preventing excessive localized pressure on the balloon and reducing the risk of damage to intestinal tissue, thus ensuring normal intestinal physiological function.

[0045] Reference Figures 2-4 As shown, in some embodiments, the outer wall of the annular balloon 1 has a wavy anti-slip structure. This wavy anti-slip structure significantly enhances the friction between the annular balloon 1 and the intestinal wall, effectively preventing the balloon from sliding and shifting within the intestine. This ensures that the balloon can continuously and stably provide support and protection to specific parts of the intestine, guaranteeing normal intestinal function and reducing the risk of complications caused by balloon displacement, such as anastomotic tearing and intestinal obstruction.

[0046] Furthermore, this structure ensures a closer and more uniform contact between the balloon and the intestinal wall, evenly distributing the supporting pressure exerted by the balloon on the intestine. This avoids problems such as intestinal mucosal damage and ischemia caused by excessive local pressure, improving patient comfort when using the balloon and protecting the health of intestinal tissue. Specifically, when the balloon applies pressure to the intestinal wall, the peaks and troughs of the wave-shaped structure contact the intestinal wall, dispersing the pressure along the wave shape. Compared to a flat outer wall of the balloon, the wave-shaped structure prevents pressure from concentrating at a few points or areas, instead distributing the pressure evenly across the entire contact surface. During intestinal peristalsis, the wave-shaped structure better conforms to intestinal movement, ensuring a consistently even pressure distribution and reducing excessive compression of local intestinal tissues.

[0047] Of course, the above description is not limiting. In some alternative embodiments, a granular anti-slip structure can be provided. Specifically, dense granular protrusions are provided on the outer wall of the annular balloon 1. These particles increase the friction with the intestinal wall by increasing surface roughness. When the particles come into contact with the intestinal wall, numerous tiny friction points are formed, similar to adding countless microscopic "grip forces," thereby effectively preventing the balloon from slipping. At the same time, the elasticity of the particles can buffer the pressure of the balloon on the intestine to a certain extent, dispersing the pressure among the particles and avoiding excessive local pressure.

[0048] Advantages: The granular structure is relatively easy to manufacture and can be formed on the surface of the balloon through processes such as molding and injection molding. Moreover, the size, shape, and distribution density of the particles can be adjusted according to actual needs to adapt to different intestinal conditions and anti-slip requirements.

[0049] Disadvantages: The particles may cause some abrasion to the intestinal wall, especially during intestinal peristalsis. It is necessary to select appropriate particle materials and surface treatments to ensure biocompatibility and safety for the intestines. Furthermore, if the particles are not securely fixed, they may detach inside the intestines, posing a potential risk.

[0050] In some alternative embodiments, a mesh-like anti-slip structure can be provided. Specifically, a mesh-like raised structure is constructed on the outer wall of the balloon. The lines of the mesh intersect to form multiple small mesh areas, increasing the contact area and friction with the intestinal wall. The mesh structure can act like a "cage," containing part of the intestinal wall tissue, enhancing the mechanical locking effect and preventing balloon displacement. At the same time, the mesh framework can disperse pressure, ensuring that the pressure is evenly distributed within the area covered by the mesh.

[0051] Advantages: The mesh structure offers good flexibility and adaptability, adjusting its shape to accommodate balloon deformation and intestinal peristalsis, maintaining excellent anti-slip and pressure dispersion effects. Furthermore, the mesh design provides some breathability, helping to maintain the normal physiological environment of the intestinal wall.

[0052] Disadvantages: The manufacturing process of the mesh structure is relatively complex, requiring precise control of parameters such as mesh size, thickness, and spacing. Furthermore, intestinal secretions or impurities may remain in the gaps between the meshes, necessitating regular cleaning and maintenance to prevent infections and other problems.

[0053] In some alternative embodiments, a spiral anti-slip structure can be provided. Specifically, a spiral protrusion or groove is provided on the outer wall of the annular balloon 1. The spiral shape extends along the circumference of the balloon, and when the balloon is placed in the intestine, the spiral structure forms a spiral frictional distribution with the intestinal wall. This distribution not only increases friction but also guides the direction of intestinal peristalsis, making the balloon more stable during intestinal peristalsis. At the same time, the spiral structure can disperse the pressure of the balloon along the spiral direction, avoiding pressure concentration in local areas.

[0054] Advantages: The spiral structure better conforms to the peristaltic rhythm of the intestines, utilizing the intestines' own peristaltic force to enhance the anti-slip effect. Furthermore, the spiral shape can provide some guidance, helping the balloon maintain its correct position within the intestines.

[0055] Disadvantages: The spiral structure may interfere with normal intestinal peristalsis, requiring careful design of parameters such as the spiral pitch and height to balance the anti-slip effect and the impact on intestinal peristalsis. Furthermore, the spiral structure is more difficult to manufacture, requiring high precision in the molds.

[0056] Reference Figure 4 As shown, in some embodiments, the support frame 4 is a shape memory metal woven mesh support. The shape memory metal woven mesh support can provide stable and reliable support for the central hole of the annular balloon 1, effectively preventing the central hole from being too small after the balloon is inflated, ensuring that the contents of the colon and rectum 9 pass through smoothly, and maintaining the normal excretory function of the intestine.

[0057] Thanks to the unique shape memory properties and good flexibility of shape memory metal, the mesh scaffold can adapt to intestinal peristalsis, bending and changes in body position to a certain extent, reducing damage to the intestine caused by excessive rigidity of the scaffold and improving patient comfort.

[0058] Of course, the above description is not limiting. In some alternative embodiments, a polymer elastic mesh scaffold can be used. Specifically, a polymer material with high elasticity and good biocompatibility, such as medical-grade polyurethane or silicone rubber, is selected and fabricated into a mesh scaffold through processes such as injection molding or 3D printing. These polymers themselves are elastic and can maintain the shape of the central hole by their own elastic deformation when the balloon is inflated.

[0059] Polymer materials are relatively inexpensive, have simple manufacturing processes, and can be mass-produced. Their elasticity and softness can further improve patient comfort. Of course, compared to shape memory metals, polymers may have slightly lower strength and may deform or age under prolonged balloon inflation pressure, affecting support effectiveness.

[0060] Reference Figure 4 As shown, in some embodiments, the support frame 4 is made of a radiopaque material. When the support frame 4 is made of a radiopaque material, it can be clearly visualized under medical imaging equipment, allowing doctors to determine the position of the colorectal anastomosis protection device within the intestine in real time and with precision, especially the position of the support frame 4 and the connected annular balloon 1. This is crucial for ensuring the device is accurately placed at key locations such as the colorectal anastomosis 10, helping to improve treatment outcomes and preventing support and protection failure due to device misalignment.

[0061] During treatment, medical imaging examinations can be used to monitor for any displacement or deformation of the device. For example, if the device changes position due to intestinal peristalsis or patient movement, or if the support frame 4 deforms due to factors such as balloon inflation, the imaging material will clearly show these changes in the images. Doctors can then adjust the treatment plan accordingly to ensure the device continues to function effectively and reduce the risk of complications.

[0062] This embodiment also provides a method for protecting the anastomosis 10 of the colorectal 9, including the following steps: Reference Figure 1 , Figure 2 As shown, the colorectal anastomosis protection device described in the above scheme is inserted above the anastomosis 10 of the colorectal 9, so that the protective sleeve 3 is located at the anastomosis 10. Reference Figure 3 , Figure 4 As shown, the annular balloon 1 is inflated so that the outer wall of the annular balloon 1 fits against the inner wall of the colon and rectum 9, and the support frame 4 is spread out on the inner wall of the central hole of the annular balloon 1.

[0063] The technical solution provided in this embodiment provides direct protection for the anastomosis 10 by accurately placing the protective device above the anastomosis 10 and positioning the protective sleeve 3 at the anastomosis 10. After inflation, the circular balloon 1 adheres to the inner wall of the colon and rectum 9, providing even support to the intestine, reducing pressure at the anastomosis 10, lowering the risk of the anastomosis 10 rupture due to intestinal peristalsis and changes in intraluminal pressure, and promoting the healing of the anastomosis 10.

[0064] The support frame 4 is spread open on the inner wall of the central hole of the circular balloon 1 to prevent the central hole of the balloon from being too small after inflation, ensuring that the contents of the colon and rectum 9, such as feces and digestive juices, can pass smoothly, maintaining the normal excretory function of the intestine, and preventing a series of complications caused by intestinal blockage, such as intestinal obstruction and infection.

[0065] The decompression principle of anastomosis 10: When the circular balloon 1 is inflated and adheres to the inner wall of the colon and rectum 9, the balloon generates an outward supporting force on the intestinal wall. This supporting force can disperse the pressure within the intestine, relieving the pressure originally concentrated at anastomosis 10. During intestinal peristalsis, the balloon can buffer the pressure changes on the intestinal wall, reducing traction and impact on anastomosis 10, and creating a stable mechanical environment for the healing of anastomosis 10.

[0066] The principle behind maintaining the patency of the central orifice: The support frame 4 is made of a material less flexible than the annular balloon 1. When the balloon is inflated, its strong supporting force maintains the shape and size of the central orifice. This ensures that substances in the intestine can pass normally through the central orifice and continue to move within the intestine, avoiding the narrowing or even blockage of the central orifice due to balloon inflation, thus maintaining intestinal patency.

[0067] Reference Figure 5 As shown, in some embodiments, a pressure sensor 5 and a gas filling / discharging control unit are connected to the gas filling / discharging pipeline 2. The pressure sensor 5 is connected to the controller, and the controller is connected to the gas filling / discharging control unit. When the contents of the colon and rectum 9 pass through, the controller controls the inflation and deflation control unit to increase the pressure of the annular balloon 1. After the contents of the colon and rectum 9 have passed through, the controller controls the inflation and deflation control unit to decrease the pressure of the annular balloon 1.

[0068] In the above-described scheme, increasing the pressure of the circular balloon 1 as the contents of the colon and rectum 9 pass through enhances support for the intestine, prevents local deformation caused by pressure impact during passage, better protects the anastomosis 10, and avoids excessive stress on the anastomosis 10 due to impact from the contents, which could affect healing. Reducing the pressure after the contents have passed reduces prolonged high-pressure compression of the intestinal wall by the balloon, preventing ischemia and damage to the intestinal mucosa, improving patient comfort, and facilitating the recovery of intestinal blood circulation, thus ensuring normal intestinal physiological function.

[0069] This system can automatically and in real time adjust the balloon pressure based on the dynamic process of colorectal contents passing through the rectum, achieving intelligent and adaptive pressure regulation without the need for frequent manual intervention by medical staff, thus improving nursing efficiency and treatment accuracy.

[0070] Pressure sensing principle: Pressure sensor 5 monitors the pressure inside inflation / deflation pipe 2 in real time, indirectly reflecting the pressure inside the annular balloon 1. When the contents of the colon and rectum 9 pass through, it causes a momentary change in intestinal pressure. This change is transmitted to the balloon, causing pressure fluctuations inside the balloon. Pressure sensor 5 senses the pressure fluctuation signal and converts it into an electrical signal, which is then transmitted to the controller.

[0071] Control Decision Principle: The controller receives and analyzes the electrical signal from pressure sensor 5. When it detects a pressure fluctuation pattern consistent with the pressure change pattern during the passage of contents (e.g., a sudden increase in pressure that lasts for a period of time), the controller determines that contents are passing through and sends a command to the inflation / deflation control unit to increase the balloon pressure. When the pressure fluctuation returns to the normal range, indicating that contents have passed through, the controller sends a command to decrease the balloon pressure.

[0072] Pressure regulation principle: After receiving instructions from the controller, the inflation / deflation control unit regulates the pressure inside the balloon by controlling the working status of the inflation device 6 (such as an air pump) and the opening and closing of the electrically controlled valves (inflation valve 7 and deflation valve 8). When increasing the pressure, the inflation device 6 starts or accelerates the inflation speed, the inflation valve 7 opens, and the deflation valve 8 closes; when decreasing the pressure, the deflation valve 8 opens, the gas inside the balloon is expelled, and if necessary, the inflation device 6 stops working or slows down the inflation speed.

[0073] Although embodiments of the present invention have been described in conjunction with the accompanying drawings, those skilled in the art can make various modifications and variations without departing from the spirit and scope of the present invention, and such modifications and variations all fall within the scope defined by the present invention.

Claims

1. A colorectal anastomosis protection device, characterized in that, include: An annular balloon (1) has an inflation port connected to an inflation / deflation pipe (2). The protective sleeve (3) is connected to the annular balloon (1). One end of the central channel of the protective sleeve (3) is connected to the central hole of the annular balloon (1), and the other end extends away from the annular balloon (1). The support frame (4) is supported on the inner wall of the central hole of the annular balloon (1), and the flexibility of the support frame (4) is less than that of the annular balloon (1).

2. The colorectal anastomosis protection device according to claim 1, characterized in that, The inflation / deflation pipeline (2) is connected to a pressure sensor (5) and an inflation / deflation control unit. The pressure sensor (5) is connected to the controller, and the controller is connected to the inflation / deflation control unit.

3. The colorectal anastomosis protection device according to claim 2, characterized in that, The inflation / deflation control unit includes an inflation device (6) and an electrically controlled valve connected to the inflation / deflation pipeline (2).

4. The colorectal anastomosis protection device according to claim 3, characterized in that, The electrically controlled valve includes an inflation valve (7) and an venting valve (8).

5. The colorectal anastomosis protection device according to any one of claims 1-4, characterized in that, The outer wall of the annular balloon (1) is provided with an anti-slip structure.

6. The colorectal anastomosis protection device according to any one of claims 1-4, characterized in that, The outer wall of the annular balloon (1) has a wave-shaped anti-slip structure.

7. The colorectal anastomosis protection device according to any one of claims 1-4, characterized in that, The support frame (4) is a mesh support woven from memory metal.

8. The colorectal anastomosis protection device according to any one of claims 1-4, characterized in that, The support frame (4) is made of developing material.

9. A method for protecting a colorectal anastomosis, characterized in that, Includes the following steps: The colorectal anastomosis protection device according to any one of claims 1-8 is inserted above the anastomosis (10) of the colorectal (9) so that the protective sleeve (3) is located at the anastomosis (10); Inflate the circular balloon (1) so that the outer wall of the circular balloon (1) fits against the inner wall of the colon and rectum (9), and the support frame (4) is spread open on the inner wall of the central hole of the circular balloon (1).

10. The method for protecting the colorectal anastomosis according to claim 9, characterized in that, A pressure sensor (5) and a gas filling and discharging control unit are connected to the gas filling and discharging pipeline (2). The pressure sensor (5) is connected to the controller, and the controller is connected to the gas filling and discharging control unit. When the contents of the colon (9) pass through, the controller controls the inflation and deflation control unit to increase the pressure of the annular balloon (1). After the contents of the colon (9) pass through, the controller controls the inflation and deflation control unit to decrease the pressure of the annular balloon (1).

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