Portable pressurizing hemostasis air bag device used after anus operation

Abstract

The invention relates to a portable anus postoperative pressurization hemostasis air bag device which comprises an air bag body, an inflation and exhaust pipe and a one-way valve. The air bag body comprises an annular inner layer, an annular outer layer, an annular front end sealing layer and an annular rear end sealing layer, the outer layer is arranged around the periphery of the inner layer, and a center through hole is defined by the inner layer; the front end sealing layer and the rear end sealing layer are arranged at the two ends of the inner layer and the two ends of the outer layer respectively and connected with the inner layer and the outer layer to define an annular inflation cavity, and the inflation cavity is arranged around the periphery of the center through hole. The one-way valve is mounted in the central through hole, so that gas can be only conveyed from the front end to the rear end of the airbag body. The inflation cavity isolated from the center through hole is formed through the annular double-layer structure, 360-degree uniform annular compression is achieved after inflation, and meanwhile the center through hole is kept unobstructed so that exhaust and defecation can be facilitated; the one-way valve realizes directional gas delivery and prevents contents from flowing back. The compression hemostasis effect and exhaust and defecation smoothness are both considered, the structure is simplified, and operation is convenient and fast.

Description

Technical Field

[0001] This application relates to the field of medical device technology, and in particular to a portable postoperative pressure hemostasis balloon device for anal surgery. Background Technology

[0002] Hemorrhoids (hemoptysis) are a common anorectal disease, affecting up to 39% of the population, according to epidemiological studies. For patients with severe hemorrhoids or those unresponsive to conservative treatment, hemorrhoidectomy (the surgical treatment of hemorrhoids) is the primary treatment. Although the complication rate of hemorrhoidectomy is generally low, its incidence and severity vary depending on surgical technique and the extent of tissue damage during the procedure. Common complications after hemorrhoidectomy include minor bleeding, local swelling, urinary retention, and perianal abscess formation. Postoperative bleeding is a clinically critical issue requiring close monitoring. Early postoperative bleeding requires close monitoring, while delayed bleeding (usually occurring 7 to 16 days post-surgery) is more challenging to manage, with an incidence of approximately 1-2%. This stage coincides with the critical window period for hemorrhoid necrosis and sloughing off; excessive straining during bowel movements or friction from hard stools can trigger bleeding, sometimes requiring anal exploration and suturing / ligation in severe cases. Clinical cases show that on the seventh day after surgery for mixed hemorrhoids, patients may still experience sudden and severe bleeding from the wound after straining during bowel movements. This can quickly lead to symptoms such as paleness and palpitations, requiring emergency treatment. Therefore, in postoperative care, effectively applying pressure to the anorectal wound to stop bleeding without affecting the patient's normal bowel movements and gas passage is a pressing technical problem that needs to be solved.

[0003] To address the aforementioned postoperative hemostasis needs, various pneumatic compression hemostasis devices have been developed in the current technology. The basic principle of these devices is to inflate the balloon with gas or liquid, causing it to expand and apply pressure to the anal and rectal walls, thereby achieving hemostasis. For example, clinically, there is an inflatable anal tube consisting of a standard latex anal tube, an inflatable balloon, an inflation nozzle, and a bulb. The latex inflatable balloon is attached to the distal end of the anal tube approximately 5 cm from the drainage hole. This device can be used for local pressure hemostasis of general bleeding disorders of the anal canal and rectum. During use, the anal tube is inserted to a depth of 10-12 cm, and the inflation pressure causes the balloon to expand close to the four lateral walls of the rectum and anal canal, utilizing the pressure generated by the balloon's expansion to achieve hemostasis. However, in this inflatable anal tube design, the air bladder is merely an accessory attached to the anal canal. While the bladder itself forms a ring around the anal canal, its inflation occupies radial space around the canal. Since the anal canal itself (as the central passage) has a limited diameter, this may affect the smooth passage of gas and loose stools from the intestines. When a patient needs to expel gas, the airflow must pass through the relatively narrow internal passage of the anal canal, potentially restricting the smoothness of gas expulsion.

[0004] Another technical approach involves using a dual-balloon structure to achieve dual compression or fixation. For example, patent CN203802520U discloses a compression hemostasis device for anorectal diseases and post-perianal surgery, in which an inner and outer balloon are fitted onto a drainage tube, with a distance of 2cm to 4cm between the inner and outer balloons. This device uses two balloons to clamp the anus between them, preventing the anal canal from moving within the body, while simultaneously providing compression, hemostasis, drainage, enemas, and drug flushing. However, this dual-balloon structure is relatively complex. The two balloons are connected to the inflation interface via independent inflation tubes, and each inflation tube has a valve for control, increasing the manufacturing difficulty and operational complexity of the device. In actual clinical practice, medical staff need to adjust the pressure of the two balloons separately to maintain appropriate compression and fixation, making the operation process rather cumbersome. More importantly, the two balloons are located on the inner and outer sides of the anus, respectively, with the compression area mainly concentrated near the anal sphincter. For bleeding points at high anastomoses or in the upper and middle rectum, the compression effect may not be ideal.

[0005] Another patent proposes a hemostatic anal tube, including a tubing with an air-venting and defecation channel within it. An inflation / deflation port is connected to the tubing via a conduit, and an air bladder is nested within the tubing and connected to the air-venting and defecation channel. Air is injected into the air bladder through the air-venting and defecation channel using a syringe, causing the air bladder to inflate and achieve pressure hemostasis. The improvement of this design lies in using the same channel for both air-venting and defecation and air bladder inflation, simplifying the structure. However, since the air-venting and defecation channel is shared with the air bladder inflation channel, when the air bladder is inflated, a portion of the channel is used to maintain air bladder pressure, reducing the actual cross-sectional area available for air-venting and defecation, which may affect the drainage of intestinal contents. Especially under prolonged air bladder compression, the drainage path of feces and gas is restricted, easily leading to abdominal distension, discomfort, or poor drainage.

[0006] In addition to the aforementioned devices, various other technical solutions have emerged clinically, including modified rectal hemostatic balloons, disposable medical devices for postoperative hemostasis and gas expulsion in anal diseases, and compression hemostasis devices after hemorrhoidectomy. These devices generally employ a basic structure with a tubular body and an outer balloon, achieving hemostasis through compression by inflating the balloon. However, existing technologies generally share a common problem: the inflated balloon occupies a large radial space, while the cross-sectional area of ​​the central channel (usually provided by the tube itself) is limited. This makes it difficult to simultaneously achieve effective compression hemostasis and ensure the smooth flow of gas and stool. In the early postoperative period, patients' intestinal function has not fully recovered, resulting in significant gas production. If gas expulsion is obstructed, it not only increases patient discomfort but may also lead to increased abdominal pressure due to abdominal distension, thereby increasing the risk of wound bleeding. Furthermore, in existing devices, after the balloon is inflated, airflow can only pass unidirectionally through the central tube, making it impossible to control the direction or speed of gas expulsion from the intestines or prevent the backflow of rectal contents.

[0007] In summary, the main problems with the existing technology are: first, there is a lack of an integrated device that can provide uniform and controllable circumferential pressure to the anal canal and rectal wound while maintaining sufficient patency of the central channel to facilitate gas and defecation; second, existing airbag structures mostly adopt the form of airbags attached to the periphery of tubes, which compresses the effective volume of the central channel after the airbags inflate, affecting the efficiency of drainage and gas expulsion; and third, the airflow control mechanism is simplistic and does not consider the need for directional gas delivery and prevention of backflow.

[0008] Therefore, how to provide a portable postoperative pressure hemostasis balloon device for anal surgery that has a simplified structure, good compression effect, and does not affect the smoothness of gas and defecation has become a technical problem that urgently needs to be solved in this field. Summary of the Invention

[0009] The purpose of this application is to provide a portable postoperative pressure hemostasis balloon device for anal surgery, which to some extent solves the technical problems existing in the prior art.

[0010] This application provides a portable postoperative pressure hemostasis balloon device for anal surgery, comprising: a balloon body, an inflation and deflation pipe, and a one-way valve; wherein, the balloon body comprises an inner layer, an outer layer, a front sealing layer, and a rear sealing layer, all of which are annular, the outer layer is disposed around the outer periphery of the inner layer, and the inner layer itself is configured to form a central through hole;

[0011] The front sealing layer and the rear sealing layer are respectively disposed at both ends of the inner layer and the outer layer along the length direction of the airbag body, and the front sealing layer and the rear sealing layer are simultaneously connected to the inner layer and the outer layer to form an annular inflation cavity, and the inflation cavity is disposed around the outer periphery of the central through hole; the one-way valve is installed in the central through hole, and the gas can only be delivered from the front end of the airbag body to the rear end.

[0012] In the above technical solution, the portable postoperative anal pressure hemostasis balloon device further includes a heating component disposed in the inflation chamber. The heating component includes a heating ring and two fixing plates. Along the diameter direction of the annular inflation chamber, the two fixing plates are respectively fixed to the inner walls on both sides of the outer layer, and both fixing plates have mounting through holes. The heating ring passes through the mounting through holes of the two fixing plates. The central axis of the heating ring coincides with the central axis of the central through hole.

[0013] In the above technical solution, the portable postoperative pressure hemostasis balloon device for anal surgery further includes an annular plate-type stabilizing sensor, which is fixed in the inflation chamber, and the central axis of the plate-type stabilizing sensor coincides with the central axis of the central through hole.

[0014] In the above technical solution, the portable postoperative pressure hemostatic balloon device for anal surgery further includes a display screen and a controller; wherein the controller is communicatively connected to the heating ring, the plate-type stabilizing sensor, and the display screen; and / or

[0015] The number of the plate-type stabilizing sensors is multiple, and they are arranged sequentially at intervals along the length of the airbag body.

[0016] In the above technical solution, the portable postoperative anal compression hemostatic balloon device further includes a power cord, a plug, and a conductive wire harness; wherein, one end of the power cord is fixed to the rear end sealing layer of the balloon body, and the other end of the power cord is connected to the power plug; the heating ring is an electric heating ring, and the power cord is electrically connected to the heating ring through the conductive wire harness; at least a portion of the power cord is a helical elastic wire; and / or

[0017] The number of heating components is multiple, and they are arranged sequentially at intervals along the length of the airbag body.

[0018] In the above technical solution, the portable postoperative pressure hemostatic balloon device for anal surgery further includes a control valve, which is installed on the inflation and deflation pipe and is used to control the opening and closing of the inflation and deflation pipe and the flow rate of the delivered gas.

[0019] In the above technical solution, the portable postoperative pressure hemostasis balloon device for anal surgery further includes a limiting plate, a locking ring, a bolt, and a nut; wherein, the locking ring is fixed to one side of the limiting plate along its thickness direction, and the locking ring includes a ring body and two ears connected to the ring body, the limiting plate is formed with a through hole extending along its thickness direction, and the tail end of the balloon body is detachably inserted into the ring body through the through hole;

[0020] The sidewall of the ring body forms an installation notch, and the two ears are respectively disposed on both sides of the installation notch, and the two ears are fixed together by the bolt and the nut.

[0021] In the above technical solution, the inner layer is further defined as a rigid layer; and / or

[0022] The outer layer is a flexible layer; and / or the front end sealing layer is a flexible layer or a rigid layer; and / or the rear end sealing layer is a flexible layer or a rigid layer.

[0023] In the above technical solution, both the inner layer and the outer layer are cylindrical structures, and the rear end sealing layer is an annular planar structure.

[0024] In the above technical solution, the front end sealing layer is further described as an annular partially spherical structure.

[0025] Compared with the prior art, the beneficial effects of this application are as follows:

[0026] This application provides a portable postoperative pressure hemostasis balloon device for anal surgery, comprising: a balloon body, an inflation and deflation pipe, and a one-way valve; wherein, the balloon body comprises an inner layer, an outer layer, a front sealing layer, and a rear sealing layer, all of which are annular, the outer layer is disposed around the outer periphery of the inner layer, and the inner layer itself is configured to form a central through hole;

[0027] The front sealing layer and the rear sealing layer are respectively disposed at both ends of the inner layer and the outer layer along the length direction of the airbag body, and the front sealing layer and the rear sealing layer are simultaneously connected to the inner layer and the outer layer to form an annular inflation cavity, and the inflation cavity is disposed around the outer periphery of the central through hole; the one-way valve is installed in the central through hole, and the gas can only be delivered from the front end of the airbag body to the rear end.

[0028] I. Innovative ring-shaped double-layer structure to achieve uniform and controllable ring compression.

[0029] To address the shortcomings of existing airbag devices, which often use tubular components with attached airbags and suffer from uneven pressure distribution after inflation, this application constructs a complete annular inflation chamber by incorporating an inner layer, an outer layer, a front sealing layer, and a rear sealing layer, all forming a ring. Specifically, the outer layer surrounds the outer periphery of the inner layer, while the inner layer itself forms a central through-hole. The front and rear sealing layers are located at the ends of the inner and outer layers, respectively, along the length of the airbag body, and are connected to both layers, collectively forming an annular inflation chamber surrounding the central through-hole. This structural design delivers three substantial benefits:

[0030] Firstly, it achieves 360-degree uniform circumferential pressure. When air is inflated into the inflation chamber through the inflation / deflation tube, the entire balloon expands uniformly, with the inner layer slightly bulging inward and the outer layer expanding outward, forming a circumferential pressure surface surrounding the anal canal and rectal wall. Compared to balloons in existing technologies that are attached to one side or a local area of ​​a tube, the circumferential structure of this application can apply uniform and stable pressure to the wound, avoiding the problems of excessive local pressure leading to tissue damage or insufficient pressure affecting hemostasis. This uniform pressure is particularly crucial for wounds during the hemorrhoid shedding period, effectively preventing secondary bleeding caused by increased abdominal pressure during defecation.

[0031] Secondly, the double-layered structure of the inner and outer layers provides stable mechanical support. The inner layer directly contacts the anal canal wall, transmitting pressure; the outer layer acts as a constraint and reinforcement, preventing excessive inflation and deformation of the balloon, ensuring that the balloon body maintains its predetermined annular shape after inflation. The front and rear sealing layers seal the inflation chamber at both ends, while also limiting the length of the balloon body, facilitating accurate positioning during clinical insertion. This structural design prevents the balloon from axially shifting or twisting after inflation, ensuring the precision and stability of the compression position.

[0032] Thirdly, the central through-hole is formed by the inner layer itself and is independent of the inflation chamber. This "ring-shaped hollow" structure physically separates the compression function from the channel function: the inflation chamber provides the compression force, while the central through-hole is dedicated to venting and defecation. Compared to the design of the central tube channel in the airbag compression system in existing technologies, the cross-sectional area of ​​the central through-hole remains largely unaffected when the airbag is fully inflated, thus balancing effective compression and unobstructed drainage.

[0033] 2. The central through-hole is independently designed to ensure unobstructed air and waste disposal.

[0034] Addressing the technical challenge of existing airbag devices where the central channel is compressed after inflation, affecting the smooth flow of air and stool, this application fundamentally solves this problem by creating a central through-hole within the inner layer, with the central through-hole isolated from the inflation chamber. This results in the following breakthrough effects:

[0035] Firstly, it ensures smooth postoperative gas expulsion and reduces the risk of abdominal distension. After anorectal surgery, patients' intestinal function has not fully recovered, resulting in significant intestinal gas production. Poor gas expulsion not only increases patient discomfort but may also lead to increased abdominal pressure due to distension, thereby increasing the risk of wound bleeding. The central opening in this application maintains its original diameter even when the balloon is fully inflated, allowing intestinal gas to escape freely and effectively preventing gas retention. In clinical practice, patients can expel gas naturally through the central opening without additional procedures, significantly improving postoperative comfort.

[0036] Secondly, it facilitates fecal drainage and reduces wound contamination. In the early postoperative period, patients may pass loose stools or intestinal fluid. If drainage is inadequate, fecal accumulation in the rectum not only increases abdominal distension but may also contaminate the wound and cause infection. The central perforation in this application provides a clear drainage channel, allowing intestinal contents to be directly discharged through the central perforation, reducing contact time with the wound and promoting wound healing. Simultaneously, unobstructed drainage also facilitates postoperative monitoring of bleeding; medical staff can assess the bleeding level by observing the characteristics of the drainage material within the central perforation.

[0037] Thirdly, the structure is simplified, reducing the difficulty of use. Compared to existing technologies that require multiple channels in the tubing or employ complex double-balloon structures, this application achieves both compression and drainage functions through a simple design with a central through-hole enclosed within the inner layer. The balloon body is integrally molded, eliminating the need for additional tubing, simplifying the manufacturing process and reducing production costs. In clinical use, medical staff only need to insert the balloon body into the anal canal to an appropriate depth and inflate it through the inflation / deflation tube, making operation simple and reducing learning costs and the risk of misoperation.

[0038] 3. Built-in one-way valve enables directional airflow control to prevent backflow of intestinal contents.

[0039] To address the issues of existing devices having limited airflow control and failing to prevent backflow of contents, this application installs a one-way valve within the central through-hole, ensuring that gas can only be delivered from the front to the rear of the airbag body. This design brings multiple technical benefits:

[0040] Firstly, it enables the directional expulsion of intestinal gas. The one-way valve design ensures that gas within the intestines can only flow unidirectionally from the front (deep into the rectum) to the back (outside the body), while external gas cannot enter the intestines in the reverse direction. This directional control mechanism aligns with the body's physiological needs, allowing accumulated gas in the intestines to be expelled smoothly, while preventing external air from entering the rectum and causing abdominal distension and discomfort. This function is particularly important for patients requiring long-term indwelling balloons, as it helps maintain a stable intestinal environment.

[0041] Secondly, it prevents backflow and contamination from intestinal fluid and loose stool. While preventing gas from entering backwards, the one-way valve also has a certain anti-backflow function. When the patient's abdominal pressure increases (such as during coughing or straining), the one-way valve can prevent intestinal fluid or loose stool from flowing back from the rear to the front, reducing the risk of wound contamination. In some implementations, the one-way valve can adopt a duckbill valve or a valve-type structure, opening when gas is expelled forward and automatically closing when no gas is expelled, forming an effective dynamic seal.

[0042] Thirdly, it facilitates clinical enema and drug administration. When an enema or rectal administration is required, medical staff can inject liquid or medication through the one-way valve at the rear. Since the one-way valve allows gas to flow unidirectionally from front to back, the injected liquid can also smoothly enter the intestine. After the injection stops, the one-way valve automatically closes to prevent backflow and leakage of the medication. This bidirectional operability (automatically opening when venting gas and passively opening when injecting medication) allows the device to meet both the needs of venting gas and the functional requirements of therapeutic drug administration, expanding the clinical application scenarios of the device.

[0043] IV. Portable and lightweight design enhances the convenience of clinical use.

[0044] In summary, this application, through its innovative design of the balloon's structure, has a positive impact on the convenience of postoperative hemostasis procedures in anorectal surgery at a macroscopic level:

[0045] On the one hand, the device has a compact overall structure and is easy to carry. The airbag body is made of medical-grade silicone or latex material, can be folded and stored, and is equipped with an inflation / deflation tube and a one-way valve. Its small size allows it to be placed in a first aid kit or nursing case for easy carrying, making it suitable for various scenarios such as wards, outpatient clinics, and home care. If a patient experiences minor bleeding during their post-operative discharge period, they can insert the airbag themselves in time to buy precious time for compression and hemostasis.

[0046] On the other hand, the operation is simple and intuitive, requiring no complex equipment. During use, simply inflate the inflation chamber to the appropriate pressure using a syringe or manual balloon through the inflation / deflation tube; no external air source or pressure monitoring equipment is needed. Medical staff can flexibly adjust the inflation volume according to the patient's body size and wound condition, achieving personalized compression. The one-way valve also eliminates the need for additional tubing clamping, further simplifying the usage process.

[0047] Furthermore, the device can be manufactured in various sizes to meet the needs of different users. Based on clinical statistics, three models—large, medium, and small—can be designed to suit patients of different body types, ensuring effective compression while improving user comfort. The thickness and hardness of the inner and outer layers can also be adjusted according to compression requirements. For example, for high anastomotic bleeding, the outer layer thickness can be appropriately increased to enhance compression strength.

[0048] In summary, this application creatively solves the core problem of balancing compression effect and unobstructed drainage in postoperative compression hemostasis of anorectal surgery by organically integrating the annular double-layered airbag structure with the one-way valve in the central through hole. It has multiple beneficial effects, such as uniform and controllable annular compression, unobstructed gas and defecation, reliable airflow directional control, portability, ease of use and simple operation. It provides a new and feasible technical solution for the prevention and treatment of postoperative bleeding in anorectal surgery, and has significant technological advancement and broad clinical application value. Attached Figure Description

[0049] To more clearly illustrate the technical solutions in the specific embodiments of this application or 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 this application. For those skilled in the art, other drawings can be obtained from these drawings without creative effort.

[0050] Figure 1 This is a schematic diagram of the portable postoperative pressure hemostasis balloon device for anal surgery provided in the embodiments of this application;

[0051] Figure 2 This is another schematic diagram of the portable postoperative pressure hemostasis balloon device for anal surgery provided in the embodiments of this application;

[0052] Figure 3 This is a cross-sectional schematic diagram of the portable postoperative anal pressure hemostasis balloon device provided in the embodiments of this application;

[0053] Figure 4 This is an assembly diagram of the limiting plate and locking ring provided in an embodiment of this application.

[0054] Figure label:

[0055] 1-Airbag body, 101-Inner layer, 102-Outer layer, 103-Front end sealing layer, 104-Rear end sealing layer, 105-Central through hole, 106-Inflation chamber, 2-Inflation and deflation pipe, 3-One-way valve, 4-Heating assembly, 41-Heating ring, 42-Fixing plate, 5-Plate-type stabilizing sensor, 6-Power cord, 61-Helical elastic cord, 7-Plug, 8-Control valve, 9-Limiting plate, 10-Locking ring, 1001-Ring body, 1002-Mounting notch, 1003-Ear, 11-Bolt, 12-Nut. Detailed Implementation

[0056] The technical solutions of this application will be clearly and completely described below with reference to the accompanying drawings. Obviously, the described embodiments are some embodiments of this application, but not all embodiments.

[0057] The components of the embodiments of this application described and shown in the accompanying drawings can be arranged and designed in a variety of different configurations. Therefore, the following detailed description of the embodiments of this application provided in the drawings is not intended to limit the scope of the claimed application, but merely to illustrate selected embodiments of the application.

[0058] Based on the embodiments in this application, all other embodiments obtained by those skilled in the art without creative effort are within the scope of protection of this application.

[0059] In the description of this application, 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 this application and 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 this application. Furthermore, the terms "first," "second," and "third" are used for descriptive purposes only and should not be construed as indicating or implying relative importance.

[0060] In the description of this application, it should be noted that, unless otherwise expressly specified and limited, the terms "installation," "connection," and "linking" 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 mechanical connection or an electrical connection; they can refer to a direct connection or an indirect connection through an intermediate medium; and they can refer to the internal connection between two components. Those skilled in the art can understand the specific meaning of the above terms in this application based on the specific circumstances.

[0061] like Figures 1 to 4 As shown, this application provides a portable postoperative pressure hemostasis balloon device for anal surgery, mainly applicable to compression hemostasis of wounds after hemorrhoidectomy or other anorectal surgeries. Through innovative design of the balloon body structure, this device aims to solve the technical problem that existing balloon compression devices struggle to simultaneously achieve effective hemostasis while ensuring smooth gas and bowel movements.

[0062] like Figure 1 and Figure 2 As shown, the portable postoperative anal compression hemostasis balloon device includes a balloon body 1, an inflation / deflation pipe 2, and a one-way valve 3. The balloon body 1 is made of medical-grade silicone rubber or latex material, possessing good biocompatibility and elasticity. The balloon body 1 includes an annular inner layer 101, an outer layer 102, a front sealing layer 103, and a rear sealing layer 104. The outer layer 102 surrounds the outer periphery of the inner layer 101, maintaining a certain distance between them. The inner layer 101 itself forms a central through-hole 105, which penetrates both ends of the balloon body 1, serving as a channel for air and stool passage.

[0063] The front sealing layer 103 and the rear sealing layer 104 are respectively disposed at both ends of the inner layer 101 and the outer layer 102 along the length direction of the airbag body 1. The front sealing layer 103 is simultaneously sealed to the front edge of the inner layer 101 and the front edge of the outer layer 102, and the rear sealing layer 104 is simultaneously sealed to the rear edge of the inner layer 101 and the rear edge of the outer layer 102. Through this connection method, the inner layer 101, the outer layer 102, the front sealing layer 103, and the rear sealing layer 104 together form an annular closed cavity, namely the inflation chamber 106. The inflation chamber 106 is annular cylindrical in shape, arranged around the outer periphery of the central through hole 105, and isolated from the central through hole 105. The inflation / exhaust pipe 2 is installed at the rear end of the airbag body 1 and communicates with the inflation chamber 106, for injecting or expelling gas into the inflation chamber. The one-way valve 3 is installed in the central through hole 105. Its installation direction allows gas to be delivered unidirectionally from the front end (i.e. the end inserted into the body) of the airbag body 1 to the rear end (i.e. the external end), and it is cut off in the opposite direction.

[0064] The technical solution of this application achieves functional separation of compression hemostasis and unobstructed gas expulsion through the above-described structural design. Specifically, when air is inflated into the inflation chamber 106 through the inflation / deflation pipe 2, the entire airbag body 1 expands uniformly. Since both the inner layer 101 and the outer layer 102 are annular structures, the inflated airbag body 1 forms a 360-degree annular compression surface surrounding the anal canal and rectal wall. The inner layer 101 protrudes slightly inward, directly contacting and compressing the anal canal wall; the outer layer 102 expands outward, providing support and constraint. The central through-hole 105 is formed by the inner layer 101 itself, and its diameter remains essentially unchanged during airbag inflation, ensuring that gas and loose stool in the intestine can be smoothly discharged. The one-way valve 3 enables the directional discharge of intestinal gas: gas accumulated in the intestine can be smoothly discharged from front to back through the central through-hole 105, while external gas cannot enter the intestine in reverse, and it can also prevent intestinal fluid reflux to a certain extent.

[0065] As an expandable implementation, the balloon body 1 can be manufactured using a one-piece molding process, such as injection molding or dip molding, to ensure reliable sealing at all joints. The wall thickness of the inner layer 101 and the outer layer 102 can be adjusted according to clinical needs: for scenarios requiring stronger compression (such as active bleeding), the wall thickness of the inner layer 101 can be appropriately increased to enhance compression strength; for scenarios requiring long-term indwelling, a thinner inner layer 101 can be used to reduce foreign body sensation. The volume of the inflation chamber 106 can also be designed according to the specifications of the balloon body 1; for example, the inflation chamber volume of a large balloon can be designed to be 30-50ml, a medium balloon 20-30ml, and a small balloon 10-20ml, to accommodate the anatomical characteristics of patients of different body sizes. A standard Luer connector can be provided on the inflation / deflation tube 2 for easy connection to a syringe or manually inflatable balloon. The tube wall of the inflation / deflation tube 2 can also be marked with graduations to indicate reference values ​​for inflation volume.

[0066] Considering the potential for local inflammation during the healing process of anorectal surgical wounds, appropriate warm compresses can help promote local blood circulation and relieve pain and discomfort. Based on this clinical need, in a further embodiment of this application, such as Figure 2 and Figure 3 As shown, the portable postoperative anal compression hemostasis balloon device also includes a heating component 4 disposed within the inflation chamber 106. The heating component 4 includes a heating ring 41 and two fixing plates 42. Along the diameter of the annular inflation chamber 106, the two fixing plates 42 are respectively fixed to the inner walls on both sides of the outer layer 102. Both fixing plates 42 have mounting through holes, and the heating ring 41 passes through the mounting through holes of the two fixing plates 42, thereby being stably fixed in the internal space of the inflation chamber 106. The central axis of the heating ring 41 coincides with the central axis of the central through hole 105, ensuring that the heating ring 41 is located at the center of the inflation chamber 106, so that heat can be evenly conducted to the outer and inner layers.

[0067] The heating ring 41 can be made of a flexible electric heating element, such as carbon fiber heating wire wound into a ring, or a flexible graphene heating film cut into a ring. When the heating ring 41 is powered on, the generated heat is conducted through the outer layer 102 and the inner layer 101 to the surface in contact with the tissue, providing gentle heating to the anal canal. This active heating function is beneficial for postoperative pain relief: the warm stimulation can promote local vasodilation, improve blood circulation, and accelerate the metabolism of inflammatory mediators, thereby reducing pain and swelling. At the same time, the heating function works synergistically with the compression hemostasis function to form a comprehensive therapeutic effect of "compression hemostasis + hot compress analgesia".

[0068] As an expandable implementation, the number of heating components 4 can be multiple, and they can be arranged sequentially at intervals along the length of the airbag body 1. For example, three heating rings 41 can be arranged at the front, middle, and rear of the airbag body 1, each independently controlled. When the patient's pain is located deeper, the front heating ring can be activated; when the pain is located closer to the anus, the rear heating ring can be activated. This segmented heating design achieves precise heat application and avoids unnecessary heat diffusion. The power density of the heating rings 41 can be controlled within the range of 0.1-0.3 W / cm², and the surface temperature is limited to below 42°C by a temperature control module to prevent burns to tissues. The fixation plate 42 can be made of a plastic material with poor thermal conductivity (such as polytetrafluoroethylene) to reduce heat conduction loss to the airbag wall and prevent the fixation plate itself from overheating.

[0069] In clinical applications, the pressure exerted by the balloon on the anal canal wall directly affects hemostasis and patient comfort. Insufficient pressure fails to achieve hemostasis, while excessive pressure may lead to tissue ischemia and necrosis. Therefore, real-time monitoring of the pressure at the contact surface between the balloon and the tissue is of significant clinical importance. Based on this consideration, such as... Figure 3 As shown, the portable postoperative pressure hemostasis balloon device for anal surgery also includes a ring-shaped plate-type stabilizing sensor 5. The plate-type stabilizing sensor 5 is fixed inside the inflation chamber 106, and its central axis coincides with the central axis of the central through hole 105. The plate-type stabilizing sensor 5 can be a flexible pressure sensor, such as a piezoresistive thin-film sensor or a capacitive flexible sensor, capable of sensing the contact pressure between the inner layer 101 of the balloon and the anal canal wall.

[0070] The output signal of the plate-type stabilizing sensor 5 can be transmitted to an external monitoring device to display the current compression pressure value in real time. Clinical medical staff can adjust the inflation volume based on the sensor readings to maintain the compression pressure within a safe range that effectively stops bleeding without causing tissue ischemia. Studies have shown that the effective hemostatic pressure for the anal canal and rectum is typically between 30-60 mmHg; pressures exceeding 80 mmHg may affect mucosal blood supply. Individualized and precise pressure adjustment can be achieved through monitoring by the plate-type stabilizing sensor 5.

[0071] As an expandable implementation, the number of sheet-type stabilizing sensors 5 can be multiple, and they can be arranged sequentially and at intervals along the length of the airbag body 1. For example, three sheet-type stabilizing sensors 5 can be set at the front end, middle section, and rear end of the airbag body 1, respectively, to monitor the compression pressure of different segments. This multi-point monitoring design can reflect the uniformity of the compression force distribution. If the pressure of a certain segment deviates significantly from the average value, it indicates that the airbag may be twisted or unevenly inflated, which facilitates timely adjustment. The sheet-type stabilizing sensor 5 can adopt a ring-shaped thin sheet structure, which is completely attached to the inner wall of the inner layer 101, and its central through hole is consistent with the central through hole 105 of the airbag body 1, so as not to affect the gas and defecation functions. The sensor lead can be led out along the gap between the inner layer 101 and the outer layer 102, and connected to the outside through the rear sealing layer 104.

[0072] To further enhance the device's intelligence, this portable post-anal surgery pressure-based hemostatic balloon device may also include a display screen and a controller. The controller communicates with the heating ring 41, the chip-type stabilizing sensor 5, and the display screen. The controller can be a low-power microcontroller, such as an ARM Cortex-M series chip, with embedded pressure and temperature control algorithms. The display screen can be located on the external control box to display real-time parameters such as current pressure, temperature, and inflation volume. Medical personnel can read data through the display screen and set target pressure and temperature via buttons or a touchscreen. Based on the feedback signal from the chip-type stabilizing sensor 5, the controller automatically controls the solenoid valve on the inflation / deflation pipe 2 for fine-tuning, achieving closed-loop pressure control. When the pressure is below the set threshold, the controller automatically starts the inflation pump to replenish the pressure; when the pressure is above the set threshold, it automatically opens the deflation valve to release pressure. This automatic pressure maintenance function is particularly useful for patients requiring long-term indwelling balloon placement, effectively addressing pressure fluctuations caused by changes in patient position or intestinal peristalsis.

[0073] Considering the power supply requirements of heating component 4, such as Figure 2 As shown, the portable postoperative anal compression hemostasis balloon device also includes a power cord 6, a plug 7, and a conductive wire harness. One end of the power cord 6 is fixed to the rear sealing layer 104 of the balloon body 1, and the other end of the power cord 6 is connected to the power plug 7. The heating ring 41 is an electric heating ring, and the power cord 6 is electrically connected to the heating ring 41 through the conductive wire harness. To facilitate clinical operation and reduce dragging sensation, at least a portion of the power cord 6 is a spiral elastic thread 61. The spiral elastic thread 61 has a certain degree of elasticity, can be stretched to the required length during use without affecting the patient's turning over; and can automatically retract after use for easy storage and organization.

[0074] As an expandable implementation, a sealed joint and stress-relief structure can be provided at the connection between the power cord 6 and the rear sealing layer 104 to prevent wire breakage due to repeated bending. The conductive wire harness can be made of multi-strand fine copper wire stranded together and wrapped with a low-temperature resistant silicone insulation layer to ensure flexibility even in low-temperature environments. The plug 7 can be a medical-grade waterproof plug for connection to a power adapter or portable power supply box. To improve the portability of the device, a rechargeable battery box can also be configured, integrated into the control box, to power the heating components and sensors via a built-in lithium battery, eliminating the need for a power cord. The battery box can be mounted on the limiting plate 9 or hung independently by the bedside for easy carrying and movement by the patient.

[0075] In actual clinical practice, the depth of balloon insertion and the accuracy of its fixation directly affect the compression effect. If the balloon is inserted too deeply or too superficially, the compression point may deviate from the bleeding point; if the balloon shifts within the body, it may lose its compressive effect. To address this issue, such as... Figure 1 and Figure 4 As shown, the portable postoperative anal compression hemostasis balloon device also includes a limiting plate 9, a locking ring 10, a bolt 11, and a nut 12. The locking ring 10 is fixed to one side of the limiting plate 9 along its thickness direction. The locking ring 10 includes a ring body 1001 and two ears 1003 connected to the ring body 1001. The limiting plate 9 has a through hole extending along its thickness direction, and the tail end of the balloon body 1 is detachably inserted into the ring body 1001 through the through hole.

[0076] The sidewall of the ring 1001 forms an installation notch 1002, and two ears 1003 are respectively provided on both sides of the installation notch 1002. The two ears 1003 are fixed together by bolts 11 and nuts 12. When the bolts 11 and nuts 12 are tightened, the two ears 1003 move closer to each other, the diameter of the ring 1001 decreases, thereby clamping the tail end of the airbag body 1 inserted therein; when the bolts 11 and nuts 12 are loosened, the diameter of the ring 1001 increases, and the airbag body 1 can be freely removed.

[0077] During use, the limiting plate 9 is placed against the skin outside the patient's anus and secured to the buttocks with medical tape or dressing. Once the airbag body 1 is inserted to the predetermined depth, the position of the limiting plate 9 is adjusted to ensure it fits snugly against the perianal skin. Then, the bolt 11 and nut 12 are tightened to lock the tail end of the airbag body 1 into the locking ring 10. This structural design effectively prevents axial movement or rotation of the airbag body 1 within the body, ensuring the stability of the compression position. Simultaneously, the limiting plate 9 also serves as an external marker, allowing medical personnel to quickly determine the airbag insertion depth.

[0078] As an expandable implementation, the limiting plate 9 can be made into various shapes, such as circular, oval, or irregularly shaped plates that mimic the contours of the buttocks, to better conform to the curves of the human body. A medical-grade silicone pad can be provided on the bottom surface of the limiting plate 9 to increase comfort and anti-slip properties in contact with the skin. The inner wall of the locking ring 10's ring body 1001 can be provided with anti-slip textures or elastic padding to provide greater friction when clamping the airbag body 1, while preventing injury to the airbag wall. The bolts 11 and nuts 12 can be made of plastic to avoid interference from metal parts during imaging examinations such as MRI. Furthermore, the limiting plate 9 can also be provided with multiple auxiliary fixation holes for threading fixation straps or suture fixation, suitable for patients requiring long-term bed rest.

[0079] To achieve differentiated mechanical properties, the various layers of the airbag body 1 can be made of materials with different stiffnesses according to functional requirements. Specifically, the inner layer 101 can be a rigid layer, such as silicone rubber with a Shore hardness of 60-80A, to maintain a certain morphological stability during inflation and prevent excessive collapse and compression of the central through-hole. The outer layer 102 can be a flexible layer, such as silicone rubber with a Shore hardness of 20-40A, to allow it to expand fully during inflation and form a good fit with the rectal wall. The front sealing layer 103 and the rear sealing layer 104 can be either flexible or rigid layers as needed. This differentiated design allows the inner layer 101 to deform only slightly to transmit pressure during inflation, while the outer layer 102 expands significantly to adapt to the anatomical shape of the rectum, achieving a "rigid inside, flexible outside" mechanical characteristic.

[0080] As an expandable implementation, the inner layer 101 can be reinforced with a fiber layer, such as embedded nylon or polyester mesh, to further enhance its compressive strength and prevent excessive inward bulging of the inner layer 101 due to excessive inflation pressure, which would reduce the diameter of the central through-hole 105. The outer layer 102 can adopt a multi-layer composite structure, with an airtight inner layer, a skin-friendly outer layer, and an antibacterial layer sandwiched in between to inhibit bacterial growth. The front sealing layer 103 can adopt a ring-shaped partially spherical structure to better conform to the anatomical shape of the rectum, reducing resistance and discomfort during insertion. The rear sealing layer 104 can adopt a ring-shaped planar structure for easy connection with the limiting plate 9 and external devices. Both the inner layer 101 and the outer layer 102 adopt a cylindrical structure, making the entire balloon body 1 cylindrical, which facilitates standardized production and clinical use.

[0081] To facilitate clinical operation, this portable post-anal surgery pressure hemostasis balloon device also includes a control valve 8, which is installed on the inflation / deflation tube 2. The control valve 8 controls the opening and closing of the inflation / deflation tube 2 and the flow rate of the delivered gas. The control valve 8 can be a manual knob or push-pull type, allowing medical personnel to precisely control the inflation speed through rotation or push-pull operation. When rapid inflation is required, the control valve 8 can be fully opened; when fine-tuning the pressure is needed, the control valve 8 can be partially closed to achieve precise adjustment of the airflow. The control valve 8 can also integrate a one-way check valve function to prevent accidental gas leakage.

[0082] As an expandable implementation, control valve 8 can be a precision needle valve with a conical valve core. The opening is adjusted via a thread to achieve continuous and precise flow control. A flow rate scale can be provided on the housing of control valve 8 for easy reference during repeated operations. To further enhance operational convenience, control valve 8 can also be integrated with a pressure gauge to form an inflation control component. The pressure gauge displays the real-time pressure value within the inflation chamber, allowing medical personnel to directly observe the pressure gauge reading for inflation operations without the need for additional monitoring equipment. The pressure gauge can be a Bourdon tube pressure gauge or a digital pressure gauge with a range of 0-100 mmHg or 0-150 mmHg and an accuracy of ±2 mmHg.

[0083] In summary, the specific embodiments of this application, through the system integration of multiple functional modules such as the airbag body 1, inflation / deflation pipe 2, one-way valve 3, heating component 4, plate-type stabilizing sensor 5, and limiting plate 9, construct a comprehensive postoperative care device for anorectal diseases that integrates annular compression hemostasis, unobstructed gas and defecation, hot compress analgesia, pressure monitoring, and positioning fixation. Each functional module can function independently or work collaboratively, forming a complete technical solution. It should be noted that the above embodiments are merely preferred embodiments of this application and are not intended to limit the scope of protection of this application. Any modifications, equivalent substitutions, improvements, etc., made within the spirit and principles of this application should be included within the scope of protection of this application.

[0084] Finally, it should be noted that the above embodiments are only used to illustrate the technical solutions of this application, and are not intended to limit them. Although this application has been described in detail with reference to the foregoing embodiments, those skilled in the art should understand that modifications can still be made to the technical solutions described in the foregoing embodiments, or equivalent substitutions can be made to some or all of the technical features therein. Such modifications or substitutions do not cause the essence of the corresponding technical solutions to deviate from the scope of the technical solutions of the embodiments of this application.

Claims

1. A portable postoperative pressure hemostatic balloon device for anal surgery, characterized in that, include: The airbag body, inflation / deflation pipe, and one-way valve; wherein the airbag body includes an inner layer, an outer layer, a front sealing layer, and a rear sealing layer, all of which are annular, the outer layer is arranged around the outer periphery of the inner layer, and the inner layer itself is arranged to form a central through hole; The front sealing layer and the rear sealing layer are respectively disposed at both ends of the inner layer and the outer layer along the length direction of the airbag body, and the front sealing layer and the rear sealing layer are simultaneously connected to the inner layer and the outer layer to form an annular inflation cavity, and the inflation cavity is disposed around the outer periphery of the central through hole; the one-way valve is installed in the central through hole, and the gas can only be delivered from the front end of the airbag body to the rear end.

2. The portable postoperative pressure hemostatic balloon device for anal surgery according to claim 1, characterized in that, The portable postoperative anal compression hemostasis balloon device further includes a heating component disposed within the inflation chamber. The heating component includes a heating ring and two fixing plates. Along the diameter of the annular inflation chamber, the two fixing plates are respectively fixed to the inner walls on both sides of the outer layer, and both fixing plates have mounting through holes. The heating ring passes through the mounting through holes of the two fixing plates. The central axis of the heating ring coincides with the central axis of the central through hole.

3. The portable postoperative pressure hemostatic balloon device for anal surgery according to claim 2, characterized in that, The portable postoperative pressure hemostasis balloon device for anal surgery also includes an annular plate-type stabilizing sensor, which is fixed inside the inflation chamber, and the central axis of the plate-type stabilizing sensor coincides with the central axis of the central through hole.

4. The portable postoperative pressure hemostatic balloon device for anal surgery according to claim 3, characterized in that, The portable postoperative pressure hemostasis balloon device for anal surgery also includes a display screen and a controller; wherein the controller is communicatively connected to the heating ring, the plate-type stabilizing sensor, and the display screen; and / or The number of the plate-type stabilizing sensors is multiple, and they are arranged sequentially at intervals along the length of the airbag body.

5. The portable postoperative pressure hemostatic balloon device for anal surgery according to claim 2, characterized in that, The portable postoperative anal compression hemostasis balloon device further includes a power cord, a plug, and a conductive wire harness; wherein, one end of the power cord is fixed to the rear end sealing layer of the balloon body, and the other end of the power cord is connected to the power plug; the heating ring is an electric heating ring, and the power cord is electrically connected to the heating ring through the conductive wire harness; at least a portion of the power cord is a helical elastic wire; and / or The number of heating components is multiple, and they are arranged sequentially at intervals along the length of the airbag body.

6. The portable postoperative pressure hemostatic balloon device for anal surgery according to claim 1, characterized in that, The portable postoperative pressure hemostatic balloon device for anal surgery also includes a control valve, which is installed on the inflation and deflation pipe and is used to control the opening and closing of the inflation and deflation pipe and the flow rate of the delivered gas.

7. The portable postoperative pressure hemostatic balloon device for anal surgery according to claim 1, characterized in that, The portable postoperative pressure hemostasis balloon device for anal surgery also includes a limiting plate, a locking ring, a bolt, and a nut; wherein, the locking ring is fixed to one side of the limiting plate along its thickness direction, and the locking ring includes a ring body and two ears connected to the ring body, the limiting plate is formed with a through hole extending along its thickness direction, and the tail end of the balloon body is detachably inserted into the ring body through the through hole; The sidewall of the ring body forms an installation notch, and the two ears are respectively disposed on both sides of the installation notch, and the two ears are fixed together by the bolt and the nut.

8. The portable postoperative pressure hemostatic balloon device for anal surgery according to claim 1, characterized in that, The inner layer is a rigid layer; and / or The outer layer is a flexible layer; and / or The front-end sealing layer is a flexible layer or a rigid layer; and / or The rear sealing layer is either a flexible layer or a rigid layer.

9. The portable postoperative pressure hemostatic balloon device for anal surgery according to claim 1, characterized in that, Both the inner and outer layers are cylindrical structures, and the rear end sealing layer is an annular planar structure.

10. The portable postoperative pressure hemostatic balloon device for anal surgery according to any one of claims 1 to 9, characterized in that, The front-end sealing layer is a ring-shaped partially spherical structure.

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