High-oxygen environment stomach tube device for anastomotic stoma healing after esophageal cancer operation and dynamic control method

Abstract

The invention relates to a high-oxygen environment stomach tube device for anastomotic stoma healing after an esophageal cancer operation and a dynamic control method, and belongs to the technical field of medical device.The high-oxygen environment stomach tube device comprises a main catheter, positioning bags, a filling tube, an oxygen filling tube, an esophagus suction tube and a blood oxygen saturation monitoring sensor, and the positioning bags are divided into an esophagus positioning bag and a stomach positioning bag; the dynamic control method comprises the steps of preoperative evaluation, equipment preparation, intraoperative precise tube implantation and positioning, postoperative high-oxygen environment dynamic regulation and control, esophagus and stomach secretion management, nutrition support, healing index evaluation and tube withdrawal. By integrating the high-oxygen environment, negative pressure suction and nutrition / drug delivery functions, comprehensive support is provided for healing of an anastomotic stoma after an esophageal cancer operation, and by monitoring the blood oxygen saturation degree in real time and dynamically adjusting the oxygen flow and concentration, the continuous high-oxygen environment is provided for an anastomotic stoma area, the oxygenation state of local tissue is enhanced, and the occurrence rate of complications is greatly reduced.

Description

Technical Field

[0001] This invention relates to the field of medical technology, and more specifically, to a hyperoxia gastric tube device and dynamic control method for esophageal cancer surgery anastomosis healing. Background Technology

[0002] After esophageal cancer surgery, the healing of the anastomosis is crucial for the patient's recovery. Infection and anastomotic leakage are common and serious complications during the postoperative healing process. Once infection occurs, it can not only destroy newly formed tissue but also trigger a systemic inflammatory response, endangering the patient's life. Anastomotic leakage can lead to leakage of digestive fluids, causing serious consequences such as mediastinitis and pleural infection, greatly increasing the patient's mortality rate and the risk of reoperation, and bringing enormous suffering and financial burden to the patient. In traditional methods, anastomotic healing relies on the patient's own physiological recovery ability and appropriate postoperative care. However, individual differences exist, leading to extremely slow healing processes for some patients. This not only prolongs hospital stays but also increases the burden on medical resources and patient suffering. Furthermore, relying solely on the patient's own recovery ability makes it difficult to guarantee healing effectiveness, potentially resulting in incomplete or poor healing quality, which affects the patient's long-term quality of life and prognosis. Secondly, while postoperative care can play a certain auxiliary role, nursing measures are mostly routine wound cleaning and the use of anti-infective drugs, lacking effective means to directly promote the regeneration and repair of anastomotic tissue. Moreover, the effectiveness of nursing care is easily affected by various factors, such as the standardization of nursing procedures and patient compliance with nursing measures, making it difficult to consistently guarantee the anastomotic healing process.

[0003] Therefore, there is a need to provide a gastric tube device and dynamic control method for providing a high-oxygen environment for anastomotic healing after esophageal cancer surgery to solve the above technical problems. Summary of the Invention

[0004] The purpose of this invention is to provide a high-oxygen environment gastric tube device and dynamic control method for esophageal cancer surgery anastomosis healing, thereby solving the above-mentioned technical problems.

[0005] To achieve the above objectives, the present invention provides the following technical solution:

[0006] This invention discloses a hyperoxia-environmental gastric tube device for esophageal cancer surgery anastomosis healing, comprising a main tube and a positioning capsule. The main tube has an independent infusion tube and an oxygenation tube on its side wall, which are completely isolated from the lumen of the main tube. The distal end of the main tube passes through the positioning capsule and extends into the stomach, while the proximal end of the main tube extends out of the oral cavity. The positioning capsule includes an esophageal positioning capsule and a gastric positioning capsule located below the esophageal positioning capsule. The distal end of the infusion tube is connected to the lumens of both the esophageal and gastric positioning capsules. The esophageal positioning capsule and the gastric positioning capsule are inflated with water or air. The proximal end of the infusion tube is provided with an infusion connector, and an infusion switch valve is installed on the infusion connector. The main tube located between the esophageal positioning capsule and the gastric positioning capsule is surrounded by an enlarged section. The two ends of the enlarged section are sealed to the outer wall of the main tube to form an oxygenation chamber. Several oxygen outlets are circumferentially opened on the side wall of the enlarged section. The distal end of the oxygenation tube communicates with the oxygenation chamber. The proximal end of the oxygenation tube is provided with an oxygenation connector, and an oxygenation switch valve is installed on the oxygenation connector.

[0007] As a preferred embodiment of the present invention, it further includes an esophageal aspiration tube, which is disposed on the side wall of the main tube and can continuously provide negative pressure aspiration. The distal end of the esophageal aspiration tube has an esophageal aspiration port located at the upper end of the esophageal positioning capsule. The proximal end of the esophageal aspiration tube is connected to a negative pressure assembly. The distal end of the main tube has a gastric aspiration port, and the proximal end of the main tube has a through hole that communicates with the outside atmosphere or is connected to the negative pressure assembly.

[0008] As a preferred embodiment of the present invention, it further includes a blood oxygen saturation monitoring tube disposed on the side wall of the main tube, the distal end of the blood oxygen saturation monitoring tube being electrically connected to a blood oxygen saturation monitoring sensor for receiving monitoring data from the blood oxygen saturation monitoring sensor, the proximal end of the blood oxygen saturation monitoring tube being connected to a blood oxygen saturation monitoring device for analyzing the monitoring data, and the blood oxygen saturation monitoring sensor being disposed on the distal side wall of the main tube.

[0009] As a preferred embodiment of the present invention, a plurality of blood oxygen saturation monitoring sensors are provided, which are respectively disposed on the side wall of the main tube located above the esophageal positioning capsule, on the side wall of the main tube located below the gastric positioning capsule, and on the side wall of the dilated section, for monitoring changes in blood oxygen saturation in the anastomosis area and surrounding tissues after esophageal cancer surgery.

[0010] As a preferred embodiment of the present invention, the esophageal positioning capsule has a diameter of 18 mm after being filled, and the diameter of the gastric positioning capsule after being filled is determined according to the diameter of the stomach at the location where it is placed.

[0011] As a preferred embodiment of the present invention, it further includes a positioning imaging strip, which passes through the gastric positioning capsule and is disposed on the side wall of the main tube. One end of the positioning imaging strip is disposed below the oxygen outlet and the other end is disposed at the distal end of the main tube. The positioning imaging strip appears as a bright image under X-ray imaging and is used to check whether the position of the oxygen outlet corresponds to the position of the anastomosis after esophageal cancer surgery.

[0012] As a preferred embodiment of the present invention, the expanded diameter section has an olive-shaped structure, with its diameter gradually decreasing from the middle to both ends, and its two ends are connected to the outer wall of the main tube in a transitional sealing connection.

[0013] The present invention discloses a dynamic control method for a hyperoxia-environment gastric tube device for esophageal cancer surgery anastomosis healing, the method comprising the following steps:

[0014] S1. Preoperative assessment: Preoperative assessment of the patient's postoperative anastomosis location, intrathoracic pressure, and lung function to rule out contraindications to hyperoxia;

[0015] S2. Equipment preparation: Select a suitable high-oxygen release gastric tube device according to the patient's esophageal diameter and anastomosis location. The distance between the esophageal positioning capsule and the gastric positioning capsule should cover the upper and lower ends of the anastomosis by 2-3 cm. Install pressure sensors in the infusion tube and the oxygenation tube to monitor the air pressure in the positioning capsule and the oxygenation tube. Install an oxygen flow meter on the oxygenation connector.

[0016] S3. Precise intraoperative tube placement and positioning: With the assistance of X-ray imaging, the hyperoxia-release gastric tube device is implanted into the patient's esophagus, with the oxygen outlet aligned with the anastomosis. Water or air is injected into the lumen of the positioning capsule through the infusion tube to a set pressure value P, fixing the positioning capsule in the preset position. The infusion valve is then closed to maintain stable pressure within the positioning capsule, thus completing the positioning of the hyperoxia-release gastric tube device.

[0017] The range of pressure fluctuations within the positioning capsule is determined by the patient's lung function test data and satisfies the following relationship:

[0018] ΔP=μ1·FEV1+μ2·FVC

[0019] In the formula, ΔP is the pressure fluctuation range inside the positioning bag, FEV1 is the amount of gas exhaled in the first second of the patient's forced exhalation, reflecting the patency of the airway and ventilation function, FVC is the total amount of gas exhaled as quickly as possible after the patient's maximum inhalation, reflecting the elastic recoil force of the lungs and the patency of the airway, and μ1 and μ2 are the weighting coefficients of FEV1 and FVC, respectively.

[0020] S4. Dynamic control of postoperative hyperoxia environment: The oxygen supply connector is connected to the oxygen supply system. Initial oxygen parameters are set in the oxygen supply system, including oxygen flow rate Q and oxygen concentration c. The oxygen supply switch valve is opened, and oxygen is delivered to the oxygen outlet through the oxygen supply tube to continuously release oxygen to the anastomosis and its surrounding area, forming a local hyperoxia microenvironment. The changes in blood oxygen saturation SpO2 of the anastomosis and its surrounding tissues are monitored in real time by the blood oxygen saturation monitoring sensor. The oxygen flow rate Q and oxygen concentration c are adjusted according to the monitoring data.

[0021] S5. Management of esophageal and gastric secretions: The proximal end of the esophageal suction tube is continuously connected to the negative pressure component, which continuously suctions saliva and exudate accumulated on the esophageal positioning sac; the proximal gap of the main tube is connected to the negative pressure component, and the gap suctions gastric juice refluxed from the stomach.

[0022] S6. Nutritional support: Nutritional fluid is delivered to the stomach through the main tube according to the patient's nutritional needs;

[0023] S7. Healing Index Assessment: The healing index is the stiffness E of the healing site tissue. A high-frequency ultrasound probe is used to scan the anastomosis area, emitting shear waves and measuring the propagation velocity v. s Calculate the stiffness E of the anastomotic tissue, satisfying the following relationship:

[0024] E = 3ρv s 3

[0025] Where ρ is the density of the anastomosing tissue, in g / cm³. 3 By using CT scans of the anastomosis area and quantifying the healing index (AHI) through 3D modeling, the healing status of the anastomosis can be assessed. The healing index AHI satisfies the following relationship:

[0026]

[0027] The healing criteria are: the stiffness of the anastomotic tissue E ≤ 50 kPa and the healing index AHI ≥ 95%;

[0028] S8. Tube Removal: Once the healing criteria are met, completely release the pressure of the positioning bag and stop oxygen delivery, then remove the hyperoxia gastric tube device.

[0029] As a preferred embodiment of the present invention, in step S4, the oxygen parameters are adjusted based on multi-sensor fusion monitoring data. The oxygen saturation data monitored by the oxygen saturation monitoring sensor located above the esophageal positioning pouch is (SpO2)1; the oxygen saturation data monitored by the oxygen saturation monitoring sensor located below the gastric positioning pouch is (SpO2)2; and the oxygen saturation data monitored by the oxygen saturation monitoring sensor located on the side wall of the dilation segment is (SpO2)3. The comprehensive oxygen saturation data (SpO2) is calculated based on the weights of each oxygen saturation monitoring sensor. 综合 It satisfies the following relationship:

[0030] (SpO2) 综合 =γ1·(SpO2)1+γ2·(SpO2)2+γ3·(SpO2)3

[0031] In the formula, γ1, γ2, and γ3 are weighting coefficients, which are used to synthesize blood oxygen saturation data (SpO2). 综合 When the oxygen level is less than 92%, an alarm is triggered to remind the operator to adjust the oxygen parameters of the oxygen supply system and increase the oxygen flow rate by 0.5 L / min.

[0032] As a preferred embodiment of the present invention, step S4 employs a PID algorithm to regulate oxygen parameters, including the following steps:

[0033] S401. Calculate the error between the real-time SpO2 value and the target value of blood oxygen saturation data: Calculate the error e(t) between the real-time SpO2 value monitored by the blood oxygen saturation monitoring sensor installed on the side wall of the expanded section and the target value, satisfying the following relationship:

[0034] e(t) = SpO2' - SpO2

[0035] In the formula, SpO2' is the target value of blood oxygen saturation data, and SpO2 is the real-time value of blood oxygen saturation data; when e(t) max When |e(t)|>0, it is necessary to adjust the oxygen parameters using a PID algorithm and continuously monitor changes in blood oxygen saturation data (SpO2); where e(t) max This is the threshold value for exceeding the limit; when |e(t)| > e(t). max When this occurs, the emergency brake is triggered, and medical staff are notified to check the equipment status and the patient's physiological indicators.

[0036] S402. Initialize PID parameters: Initialize and set the parameters of the PID algorithm, including the proportional constant K. p Integral constant K i Differential constant K d ;

[0037] S403. Calculate the control quantity based on the PID algorithm:

[0038]

[0039] In the formula, Output(t) is the PID output value, and K p K is a proportionality constant. i K is the integration constant. d is a differential constant; where the output limit is the oxygen flow rate Q within the adjustment range of 0.5 L / min to 5 L / min, and the oxygen concentration c within the adjustment range of 21% to 100%;

[0040] S404. Adjusting Oxygen Parameters: Based on the bivariate collaborative control strategy, oxygen flow rate Q is set as the primary control variable, and oxygen concentration c is set as the compensation variable. The target blood oxygen saturation SpO2' is achieved primarily by adjusting the oxygen flow rate Q. The adjustment rules are as follows:

[0041] When Output(t) > 0, the PID output value is positive, indicating that the current real-time blood oxygen saturation data SpO2 is lower than the target value, and the oxygen flow rate needs to be increased to improve oxygen supply.

[0042] Q' = Q0 + output(t)·α

[0043] When Output(t) < 0, the PID output value is negative, indicating that the current real-time blood oxygen saturation data SpO2 is higher than the target value, and the oxygen flow rate needs to be reduced to avoid over-oxygen supply.

[0044] Q' = Q0 - |output(t)|·α

[0045] In the formula, Q' is the adjusted oxygen flow rate, Q0 is the initial oxygen flow rate, and α is the proportional coefficient, which is used to control the sensitivity of the oxygen flow rate adjustment.

[0046] When the oxygen flow rate Q is adjusted to its limit but still cannot meet the target blood oxygen saturation SpO2', the concentration compensation mechanism is activated. The target blood oxygen saturation SpO2' is achieved by adjusting the oxygen concentration c. The adjustment rules are as follows:

[0047] When the adjusted oxygen flow rate Q' = Qmax and e(t) > 0, the oxygen flow rate has reached its upper limit, but the real-time blood oxygen saturation data SpO2 is still lower than the target value. Therefore, the oxygen concentration c needs to be increased to enhance the oxygen delivery efficiency per unit flow rate.

[0048] c' = c0 + output(t)·β

[0049] When the adjusted oxygen flow rate Q' = Qmin and e(t) < 0, the oxygen flow rate has reached the lower limit, but the real-time blood oxygen saturation data SpO2 is still higher than the target value, so the oxygen concentration c needs to be reduced to decrease oxygen supply.

[0050] c' = c0 - |output(t)|·β

[0051] In the formula, c' is the adjusted oxygen concentration, c0 is the initial oxygen concentration, and β is the compensation coefficient, which is used to control the magnitude of oxygen concentration adjustment.

[0052] S405. Real-time monitoring and adaptive optimization: Collect real-time SpO2 data every 5 seconds, update the error e(t) and PID output, record the effect curves of the adjusted oxygen flow rate Q' and oxygen concentration c' on SpO2, and continuously optimize the PID parameters in step S402.

[0053] In summary, compared with the prior art, the beneficial effects of the present invention are:

[0054] The hyperoxia gastric tube device of the present invention provides comprehensive support for the healing of anastomotic sites after esophageal cancer surgery by integrating hyperoxia environment, negative pressure suction and nutrition / drug administration functions. By continuously providing a local hyperoxia environment, precisely controlling oxygen flow and concentration, and monitoring blood oxygen saturation in real time, it effectively helps blood circulation and tissue repair in the anastomotic area, accelerating the healing process. At the same time, the negative pressure suction mechanism reduces the accumulation of secretions and gastric reflux, reduces the risk of complications, and further improves the treatment effect and the quality of postoperative recovery for patients.

[0055] The dynamic control method of this invention creates a favorable treatment environment by precisely regulating oxygen flow rate and concentration in conjunction with a negative pressure suction mechanism. Through real-time monitoring of blood oxygen saturation, it dynamically adjusts oxygen flow rate and concentration accordingly to optimize oxygenation in the anastomotic region. Simultaneously, the negative pressure suction mechanism effectively removes fluid accumulation in the esophagus and stomach, reducing adverse stimulation of the anastomosis site by secretions and lowering the risk of infection. This dynamic control strategy enables refined management of the treatment process, providing personalized treatment plans based on the patient's specific condition, ensuring both high efficiency and precision. Attached Figure Description

[0056] Figure 1 This is a schematic diagram of the implantation of the hyperoxia-environment gastric tube device for esophageal cancer surgery anastomosis healing into the esophagus according to the present invention.

[0057] Figure 2 This is a three-dimensional schematic diagram of the hyperoxia-environment gastric tube device for esophageal cancer surgery anastomosis healing according to the present invention.

[0058] Figure 3 for Figure 2 A magnified view of a portion of the image;

[0059] Figure 4 This is a cross-sectional view of the expanded diameter section of the present invention;

[0060] Figure 5This is a cross-sectional view of the hyperoxia-environment gastric tube device for esophageal cancer surgery anastomosis healing according to the present invention.

[0061] Figure 6 for Figure 5 A magnified view of a portion of the image;

[0062] Figure 7 This is a flowchart of the dynamic control method for the hyperoxia environment gastric tube device for esophageal cancer surgery anastomosis healing according to the present invention.

[0063] Among them, 1-main tube, 11-gastric suction port, 12-through hole, 2-positioning capsule, 21-esophageal positioning capsule, 22-gastric positioning capsule, 3-injection tube, 31-injection switch valve, 4-oxygenation tube, 41-oxygenation switch valve, 5-diameter expansion section, 51-oxygenation chamber, 52-oxygen outlet, 6-esophageal suction tube, 61-esophageal suction port, 7-blood oxygen saturation monitoring sensor, 8-blood oxygen saturation monitoring device, 9-positioning contrast strip. Detailed Implementation

[0064] The specific embodiments of the present invention will be described in detail below with reference to the accompanying drawings. It should be understood that the specific embodiments given herein are for illustration and explanation only and are not intended to limit the present invention.

[0065] like Figures 1 to 6 As shown, the hyperoxia gastric tube device for esophageal cancer surgery anastomosis healing includes: a main tube 1 and a positioning capsule 2. The main tube 1 has an independent infusion tube 3 and an oxygenation tube 4 on its side wall, which are completely isolated from the lumen of the main tube 1. The distal end of the main tube 1 passes through the positioning capsule 2 and extends into the stomach, while the proximal end of the main tube 1 extends out of the oral cavity. The positioning capsule 2 includes an esophageal positioning capsule 21 and a gastric positioning capsule 22 located below the esophageal positioning capsule 21. The distal end of the infusion tube 3 is connected to both the lumen of the esophageal positioning capsule 21 and the lumen of the gastric positioning capsule 22. The esophageal positioning capsule 21 and the gastric positioning capsule 22 are connected and filled with water or air. The proximal end of the filling tube 3 is provided with a filling connector, and a filling switch valve 31 is installed on the filling connector. The main tube 1 located between the esophageal positioning capsule 21 and the gastric positioning capsule 22 is surrounded by an enlarged section 5. The two ends of the enlarged section 5 are sealed to the outer wall of the main tube 1 to form an oxygenation chamber 51. Several oxygen outlets 52 are circumferentially opened on the side wall of the enlarged section 5. The distal end of the oxygenation tube 4 is connected to the oxygenation chamber 51. The proximal end of the oxygenation tube 4 is provided with an oxygenation connector, and an oxygenation switch valve 41 is installed on the oxygenation connector.

[0066] Based on the location and length of the anastomosis, the spacing between the esophageal positioning capsule 21 and the gastric positioning capsule 22 is designed to ensure coverage of the upper and lower ends of the anastomosis after esophageal cancer surgery. Furthermore, by inflating or injecting water into the esophageal positioning capsule 21 and the gastric positioning capsule 22, the position of the devices can be effectively fixed, preventing slippage between the positioning capsule 2 and the anastomosis. Simultaneously, it closes the upper and lower areas of the anastomosis, providing a localized high-oxygen environment to aid tissue oxygenation and cell repair, accelerating collagen synthesis and angiogenesis. To prevent prolonged pressure from obstructing blood flow and to ensure normal blood supply to the tissues, the positioning capsule 2 can be intermittently inflated and deflated, reducing the impact of continuous pressure on blood flow and effectively preventing circulatory disorders caused by compression.

[0067] In a preferred embodiment of the present invention, an esophageal aspiration tube 6 is also included. The esophageal aspiration tube 6 is disposed on the side wall of the main tube 1 and can continuously provide negative pressure aspiration. An esophageal aspiration port 61 is provided at the distal end of the esophageal aspiration tube 6. The esophageal aspiration port 61 is located at the upper end of the esophageal positioning capsule 21. A negative pressure component is connected to the proximal end of the esophageal aspiration tube 6. A gastric aspiration port 11 is provided at the distal end of the main tube 1. A through hole 12 is provided at the proximal end of the main tube 1. The through hole 12 communicates with the outside atmosphere or is connected to the negative pressure component.

[0068] When the esophageal positioning capsule 21 is inflated, swallowed saliva cannot smoothly enter the stomach, causing it to accumulate above the capsule. To prevent saliva accumulation and reduce irritation to the esophagus, an esophageal suction tube 6 is installed. Continuous negative pressure suction effectively removes the blocked saliva, ensuring the area around the esophageal positioning capsule 21 remains clean, reducing the risk of infection, and improving the postoperative healing environment. The main tube 1 connects to the negative pressure assembly for continuous suction of gastric fluids, including gastric juices and food residue. This helps maintain normal pressure and environment within the stomach, reducing the risk of reflux, alleviating gas buildup and discomfort, promoting comfortable recovery, reducing bloating and other adverse symptoms, and keeping the stomach clean to prevent local inflammation or infection caused by gastric juice retention.

[0069] As a preferred embodiment of the present invention, it further includes a blood oxygen saturation monitoring tube disposed on the side wall of the main tube 1. The distal end of the blood oxygen saturation monitoring tube is electrically connected to a blood oxygen saturation monitoring sensor 7 for receiving monitoring data from the blood oxygen saturation monitoring sensor 7. The proximal end of the blood oxygen saturation monitoring tube is connected to a blood oxygen saturation monitoring device 8 for analyzing the monitoring data. The blood oxygen saturation monitoring sensor 7 is disposed on the distal side wall of the main tube 1.

[0070] In a preferred embodiment of the present invention, a plurality of blood oxygen saturation monitoring sensors 7 are provided, which are respectively disposed on the side wall of the main catheter 1 located above the esophageal positioning capsule 21, on the side wall of the main catheter 1 located below the gastric positioning capsule 22, and on the side wall of the enlarged section 5, for monitoring changes in blood oxygen saturation in the anastomosis area and surrounding tissues after esophageal cancer surgery.

[0071] In a preferred embodiment of the present invention, the esophageal positioning capsule 21 has a diameter of 18 mm after being filled, which is slightly larger than the inner diameter of the esophageal wall. The diameter of the stomach positioning capsule 22 after being filled is determined according to the diameter of the stomach at its placement position, which is slightly larger than the diameter of the stomach at its placement position.

[0072] The diameter of the esophageal positioning capsule 21 after inflation is slightly larger than the inner diameter of the esophageal wall, which ensures a stable contact pressure between the esophageal positioning capsule 21 and the esophageal wall, effectively preventing the device from sliding or shifting in the esophagus, and ensuring that the oxygen outlet 52 and the anastomosis area always maintain accurate alignment; the gastric positioning capsule 22 is designed according to the diameter of the stomach, ensuring that the gastric positioning capsule 22 fits tightly against the stomach wall after inflation, so that the gastric positioning capsule 22 can make close contact with the stomach wall at an appropriate position in the stomach, avoiding the device from moving in the stomach, thereby reducing discomfort and risks.

[0073] As a preferred embodiment of the present invention, it also includes a positioning imaging strip 9, which passes through the gastric positioning sac 22 and is disposed on the side wall of the main tube 1. One end of the positioning imaging strip 9 is disposed below the oxygen outlet 52 and the other end is disposed at the distal end of the main tube 1. The positioning imaging strip 9 presents a bright image under X-ray imaging and is used to check whether the position of the oxygen outlet 52 corresponds to the position of the anastomosis after esophageal cancer surgery.

[0074] The positioning contrast strip 9 provides doctors with a clear visual reference, avoiding errors that may occur due to traditional manual positioning methods. Through the bright image effect, the accurate position of the device can be easily identified, reducing the risk of improper treatment and complications caused by misalignment. The positioning contrast strip 9 presents a bright image under X-ray imaging, which can effectively help doctors check and confirm in real time during the operation whether the position of the oxygen outlet 52 is completely aligned with the position of the anastomosis after esophageal cancer surgery, ensuring that oxygen can be accurately delivered to the anastomosis area.

[0075] In a preferred embodiment of the present invention, the expansion section 5 has an olive-shaped structure, and its diameter gradually decreases from the middle to both ends, with its two ends being seamlessly connected to the outer wall of the main tube 1.

[0076] The working principle of the hyperoxia gastric tube device of this invention is mainly based on controlling the hyperoxia environment to help the anastomosis healing after esophageal cancer surgery. With the assistance of X-ray imaging, the hyperoxia gastric tube device is surgically implanted into the patient's esophagus, with the oxygen outlet 52 directly facing the anastomosis. Sterile saline or air is injected into the esophageal positioning capsule 21 and the gastric positioning capsule 22 through the infusion tube 3, causing them to expand to a preset pressure and closely adhere to the esophageal and gastric walls, forming stable dual anchor points to ensure the anastomosis area is in the optimal position and provides necessary support. The oxygenation tube 4 delivers oxygen to the oxygenation chamber 51, continuously releasing oxygen to the anastomosis and surrounding tissues through multiple oxygen outlets 52 within the oxygenation chamber 51, creating a local hyperoxia environment around the anastomosis. This helps oxygenate the anastomosis tissue and promotes cell repair, accelerating collagen synthesis and angiogenesis, and improving blood oxygen saturation. The sensor monitors the blood oxygen saturation of the tissues surrounding the anastomosis in real time, providing feedback on the healing status of the anastomosis. Simultaneously, the esophageal suction tube 6, connected to a negative pressure assembly, continuously suctions saliva and exudate above the esophageal positioning capsule 21 under negative pressure, reducing the risk of complications. The gastric suction port 11 at the distal end of the main tube 1 uses intermittent negative pressure to suction gastric contents, reducing intragastric pressure and preventing gastric reflux from corroding the healing area. At the same time, the lumen of the main tube 1 can be used for enteral nutrition delivery or local drug administration, achieving integrated treatment and monitoring. This invention helps blood circulation and tissue oxygenation in the anastomosis area through a high-oxygen environment, promoting cell repair and regeneration. The oxygen concentration and flow rate can be adjusted according to the patient's specific condition, flexibly adapting to different treatment needs. The integrated multi-channel design (oxygenation, suction, nutrition / drug administration) greatly simplifies postoperative management, reduces the frequency of nursing operations, and significantly improves patient tolerance.

[0077] like Figure 7 As shown, the present invention discloses a dynamic control method for a hyperoxia-environment gastric tube device for esophageal cancer surgery anastomosis healing. The method includes the following steps:

[0078] S1. Preoperative assessment: Preoperative assessment of the patient's postoperative anastomosis location, intrathoracic pressure, and lung function to rule out contraindications to hyperoxia;

[0079] By assessing the patient's anastomosis location, intrathoracic pressure, and lung function preoperatively, contraindications to hyperoxia can be ruled out, ensuring the patient is suitable for hyperoxia therapy. This provides a reliable basis for subsequent treatment, helps to understand the patient's lung function, and ensures that the use of a hyperoxia environment during and after surgery will not cause lung-related problems, reducing unnecessary risks.

[0080] S2. Equipment preparation: Select a suitable high-oxygen release gastric tube device according to the patient's esophageal diameter and anastomosis location. The distance between the esophageal positioning capsule 21 and the gastric positioning capsule 22 should cover the upper and lower ends of the anastomosis by 2-3 cm. Install pressure sensors in the infusion tube 3 and the oxygenation tube 4 to monitor the air pressure in the positioning capsule 2 and the oxygenation tube 4. Install an oxygen flow meter on the oxygenation connector.

[0081] S3. Precise intraoperative tube placement and positioning: With the assistance of X-ray imaging, the hyperoxia-release gastric tube device is implanted into the patient's esophagus, requiring the oxygen outlet 52 to be directly aligned with the anastomosis position; water or air is injected into the lumen of the positioning capsule 2 through the injection tube 3 to the set pressure value P, so that the positioning capsule 2 is fixed in the preset position, the injection switch valve 31 is closed, and the pressure in the lumen of the positioning capsule 2 is kept stable, thus completing the positioning of the hyperoxia-release gastric tube device;

[0082] The range of pressure fluctuations within the positioning capsule 2 is determined by the patient's pulmonary function test data and satisfies the following relationship:

[0083] ΔP=μ1·FEV1+μ2·FVC

[0084] In the formula, ΔP is the pressure fluctuation range inside the positioning bag 2, FEV1 is the amount of gas exhaled in the first second of the patient's forced exhalation, reflecting the patency of the airway and ventilation function, FVC is the total amount of gas exhaled as quickly as possible after the patient's maximum inhalation, reflecting the elastic recoil force of the lungs and the patency of the airway, and μ1 and μ2 are the weighting coefficients of FEV1 and FVC, respectively.

[0085] S4. Dynamic control of postoperative hyperoxia environment: The oxygen supply connector is connected to the oxygen supply system. Initial oxygen parameters are set in the oxygen supply system, including oxygen flow rate Q and oxygen concentration c. The oxygen supply switch valve 41 is opened, and oxygen is delivered to the oxygen outlet 52 through the oxygen supply tube 4 to continuously release oxygen to the anastomosis and its surrounding area, forming a local hyperoxia microenvironment. The changes in blood oxygen saturation SpO2 of the anastomosis and its surrounding tissues are monitored in real time by the blood oxygen saturation monitoring sensor 7. The oxygen flow rate Q and oxygen concentration c are adjusted according to the monitoring data.

[0086] S5. Management of esophageal and gastric secretions: The proximal end of the esophageal suction tube 6 is continuously connected to the negative pressure component, continuously suctioning saliva and exudate accumulated on the esophageal positioning capsule 21 with negative pressure; the proximal gap of the main tube 1 is connected to the negative pressure component, and the gap suctions gastric juice refluxed from the stomach with negative pressure.

[0087] S6. Nutritional support: Nutritional fluid is delivered to the stomach through the main tube 1 according to the patient's nutritional needs;

[0088] S7. Healing Index Assessment: The healing index is the stiffness E of the healing site tissue. A high-frequency ultrasound probe is used to scan the anastomosis area, emitting shear waves and measuring the propagation velocity v.s Calculate the stiffness E of the anastomotic tissue, satisfying the following relationship:

[0089] E = 3ρv s 3

[0090] Where ρ is the density of the anastomosing tissue, in g / cm³. 3 By using CT scans of the anastomosis area and quantifying the healing index (AHI) through 3D modeling, the healing status of the anastomosis can be assessed. The healing index AHI satisfies the following relationship:

[0091]

[0092] The healing criteria are that the stiffness E of the anastomotic tissue is ≤50 kPa and the healing index AHI is ≥95%; the stiffness E of normal esophageal tissue is in the range of 20-40 kPa.

[0093] Using a high-frequency ultrasound probe to scan the anastomosis area, the stiffness E of the anastomosis tissue is calculated, and the healing index AHI is quantified through CT scan. This provides doctors with quantitative healing indicators, enabling them to clearly understand the healing status of the anastomosis and help determine whether the healing criteria are met. The quantitative criteria can accurately determine the healing process of the anastomosis, providing a basis for further treatment or tube removal.

[0094] S8. Tube Removal: Once the healing criteria are met, completely release the pressure of the positioning capsule 2 and stop oxygen delivery, then remove the hyperoxia gastric tube device.

[0095] The dynamic control method of this invention creates a favorable treatment environment by precisely regulating oxygen flow rate and concentration in conjunction with a negative pressure suction mechanism. Through real-time monitoring of blood oxygen saturation, it dynamically adjusts oxygen flow rate and concentration accordingly to optimize oxygenation in the anastomotic region. Simultaneously, the negative pressure suction mechanism effectively removes fluid accumulation in the esophagus and stomach, reducing adverse stimulation of the anastomosis site by secretions and lowering the risk of infection. This dynamic control strategy enables refined management of the treatment process, providing personalized treatment plans based on the patient's specific condition, ensuring both high efficiency and precision.

[0096] In a preferred embodiment of the present invention, in step S4, the oxygen parameters are adjusted based on multi-sensor fusion monitoring data. The oxygen saturation data monitored by the oxygen saturation monitoring sensor 7 located above the esophageal positioning pouch 21 is (SpO2)1; the oxygen saturation data monitored by the oxygen saturation monitoring sensor 7 located below the gastric positioning pouch 22 is (SpO2)2; and the oxygen saturation data monitored by the oxygen saturation monitoring sensor 7 located on the side wall of the expansion section 5 is (SpO2)3. The comprehensive oxygen saturation data (SpO2) is calculated based on the weights of each oxygen saturation monitoring sensor 7. 综合It satisfies the following relationship:

[0097] (SpO2) 综合 =γ1·(SpO2)1+γ2·(SpO2)2+γ3·(SpO2)3

[0098] In the formula, γ1, γ2, and γ3 are weighting coefficients, which are used to synthesize blood oxygen saturation data (SpO2). 综合 When the oxygen level is less than 92%, an alarm is triggered to remind the operator to adjust the oxygen parameters of the oxygen supply system and increase the oxygen flow rate by 0.5 L / min.

[0099] By using data from multiple blood oxygen saturation monitoring sensors 7 to calculate the overall blood oxygen saturation, the oxygenation status of the anastomosis area and its surrounding tissues can be comprehensively reflected, providing a more accurate understanding of the overall oxygenation status and timely judgment on whether the oxygen supply is sufficient. This provides more accurate treatment feedback and avoids problems caused by local errors or incomplete reflection of the overall situation due to a single monitoring point.

[0100] In a preferred embodiment of the present invention, step S4 employs a PID algorithm to regulate oxygen parameters, including the following steps:

[0101] S401. Calculate the error between the real-time SpO2 value and the target value of blood oxygen saturation data: Calculate the error e(t) between the real-time SpO2 value monitored by the blood oxygen saturation monitoring sensor 7 installed on the side wall of the expanded section 5 and the target value, satisfying the following relationship:

[0102] e(t) = SpO2' - SpO2

[0103] In the formula, SpO2' is the target value of blood oxygen saturation data, and SpO2 is the real-time value of blood oxygen saturation data; when e(t) max When |e(t)|>0, it is necessary to adjust the oxygen parameters using a PID algorithm and continuously monitor changes in blood oxygen saturation data (SpO2); where e(t) max This is the threshold value for exceeding the limit; when |e(t)| > e(t). max When this occurs, the emergency brake is triggered, and medical staff are notified to check the equipment status and the patient's physiological indicators.

[0104] S402. Initialize PID parameters: Initialize and set the parameters of the PID algorithm, including the proportional constant K. p Integral constant K i Differential constant K d ;

[0105] S403. Calculate the control quantity based on the PID algorithm:

[0106]

[0107] In the formula, Output(t) is the PID output value, and K p K is a proportionality constant. i K is the integration constant. d is a differential constant; where the output limit is the oxygen flow rate Q within the adjustment range of 0.5 L / min to 5 L / min, and the oxygen concentration c within the adjustment range of 21% to 100%;

[0108] S404. Adjusting Oxygen Parameters: Based on the bivariate collaborative control strategy, oxygen flow rate Q is set as the primary control variable, and oxygen concentration c is set as the compensation variable. The target blood oxygen saturation SpO2' is achieved primarily by adjusting the oxygen flow rate Q. The adjustment rules are as follows:

[0109] When Output(t) > 0, the PID output value is positive, indicating that the current real-time blood oxygen saturation data SpO2 is lower than the target value, and the oxygen flow rate needs to be increased to improve oxygen supply.

[0110] Q' = Q0 + output(t)·α

[0111] When Output(t) < 0, the PID output value is negative, indicating that the current real-time blood oxygen saturation data SpO2 is higher than the target value, and the oxygen flow rate needs to be reduced to avoid over-oxygen supply.

[0112] Q' = Q0 - |output(t)|·α

[0113] In the formula, Q' is the adjusted oxygen flow rate, Q0 is the initial oxygen flow rate, and α is the proportional coefficient, which is used to control the sensitivity of the oxygen flow rate adjustment.

[0114] When the oxygen flow rate Q is adjusted to its limit but still cannot meet the target blood oxygen saturation SpO2', the concentration compensation mechanism is activated. The target blood oxygen saturation SpO2' is achieved by adjusting the oxygen concentration c. The adjustment rules are as follows:

[0115] When the adjusted oxygen flow rate Q' = Qmax and e(t) > 0, the oxygen flow rate has reached its upper limit, but the real-time blood oxygen saturation data SpO2 is still lower than the target value. Therefore, the oxygen concentration c needs to be increased to enhance the oxygen delivery efficiency per unit flow rate.

[0116] c' = c0 + output(t)·β

[0117] When the adjusted oxygen flow rate Q' = Qmin and e(t) < 0, the oxygen flow rate has reached the lower limit, but the real-time blood oxygen saturation data SpO2 is still higher than the target value, so the oxygen concentration c needs to be reduced to decrease oxygen supply.

[0118] c' = c0 - |output(t)|·β

[0119] In the formula, c' is the adjusted oxygen concentration, c0 is the initial oxygen concentration, and β is the compensation coefficient, which is used to control the magnitude of oxygen concentration adjustment.

[0120] S405. Real-time monitoring and adaptive optimization: Collect real-time SpO2 data every 5 seconds, update the error e(t) and PID output, record the effect curves of the adjusted oxygen flow rate Q' and oxygen concentration c' on SpO2, and continuously optimize the PID parameters in step S402.

[0121] This invention monitors a patient's oxygen demand and supply in real time by calculating the error e(t) between the real-time blood oxygen saturation value and the target value. A PID algorithm adjusts the oxygen flow rate and concentration based on the magnitude of the error e(t) to ensure that blood oxygen saturation remains within the set target range, thereby accurately meeting the patient's individualized oxygen needs and avoiding adverse effects from insufficient or excessive oxygen. In practical applications, the oxygen flow rate Q is set as the primary control variable. The target blood oxygen saturation is achieved first by adjusting the oxygen flow rate. If the oxygen flow rate reaches the limit but still cannot meet the target blood oxygen saturation, the system will adjust the oxygen concentration c as a compensation variable to further optimize the oxygen supply. Under normal circumstances, oxygen flow rate adjustment can adequately control the oxygen supply, while oxygen concentration is only adjusted under extreme conditions to avoid over-oxygenation.

[0122] The system continuously updates real-time blood oxygen saturation data and calculates errors, enabling it to automatically adjust various parameters in the PID algorithm, including the constant K. p Integral constant K i and differential constant K d， This allows for optimal control over different patients and conditions. As treatment progresses, the system continuously optimizes itself to ensure the continuity and stability of the treatment effect, adapt to changes in the patient's physiological condition, and improve the flexibility and accuracy of the treatment.

[0123] Because each patient's oxygen requirements are different, the PID algorithm can automatically adjust treatment parameters based on real-time blood oxygenation data, providing personalized oxygen support plans, optimizing treatment effects, and accelerating patient recovery. By continuously adjusting oxygen flow and concentration, the system can continuously optimize the treatment plan according to the patient's physiological changes, ensuring that the anastomosis area is always in an optimal oxygen supply environment, maximizing treatment effects, accelerating the anastomosis healing process, and effectively reducing the occurrence of postoperative complications.

[0124] It should be understood that the above embodiments are one or more embodiments of the present invention. There are many other embodiments and variations based on the present invention. Any variations and modifications made by those skilled in the art without making pioneering innovations are within the protection scope of the present invention.

Claims

1. A gastric tube device for esophageal cancer surgery anastomosis healing, characterized in that... include: The system comprises a main tube and a positioning capsule. The main tube has independent infusion and oxygenation tubes on its sidewalls, which are completely isolated from the lumen of the main tube. The distal end of the main tube passes through the positioning capsule and extends into the stomach, while the proximal end extends out of the oral cavity. The positioning capsule includes an esophageal positioning capsule and a gastric positioning capsule located below it. The distal end of the infusion tube communicates with both the lumen of the esophageal positioning capsule and the lumen of the gastric positioning capsule, and is connected to both the esophageal positioning capsule and the stomach. The positioning capsule is inflated with water or air. The proximal end of the infusion tube is equipped with an infusion connector, which is fitted with an infusion switch valve. The main tube located between the esophageal positioning capsule and the gastric positioning capsule has an enlarged section around its outer periphery. The two ends of the enlarged section are sealed to the outer wall of the main tube to form an oxygenation chamber. The side wall of the enlarged section has several oxygen outlets circumferentially. The distal end of the oxygenation tube communicates with the oxygenation chamber. The proximal end of the oxygenation tube is equipped with an oxygenation connector, which is fitted with an oxygenation switch valve.

2. The hyperoxia-environmental gastric tube device for esophageal cancer surgery anastomosis healing according to claim 1, characterized in that: It also includes an esophageal aspiration tube, which is located on the side wall of the main tube and can continuously provide negative pressure aspiration. The distal end of the esophageal aspiration tube has an esophageal aspiration port located at the upper end of the esophageal positioning capsule. The proximal end of the esophageal aspiration tube is connected to a negative pressure assembly. The distal end of the main tube has a gastric aspiration port, and the proximal end of the main tube has a through hole that communicates with the outside atmosphere or is connected to the negative pressure assembly.

3. The hyperoxia-environmental gastric tube device for esophageal cancer surgery anastomosis healing according to claim 1, characterized in that: It also includes a blood oxygen saturation monitoring tube disposed on the side wall of the main tube, the distal end of the blood oxygen saturation monitoring tube being electrically connected to a blood oxygen saturation monitoring sensor for receiving monitoring data from the blood oxygen saturation monitoring sensor, the proximal end of the blood oxygen saturation monitoring tube being connected to a blood oxygen saturation monitoring device for analyzing the monitoring data, and the blood oxygen saturation monitoring sensor being disposed on the distal side wall of the main tube.

4. The hyperoxia-environmental gastric tube device for esophageal cancer surgery anastomosis healing according to claim 3, characterized in that: The blood oxygen saturation monitoring sensor is provided in several parts, which are respectively installed on the side wall of the main tube located above the esophageal positioning capsule, on the side wall of the main tube located below the gastric positioning capsule, and on the side wall of the dilated section, for monitoring the changes in blood oxygen saturation in the anastomosis area and surrounding tissues after esophageal cancer surgery.

5. The hyperoxia gastric tube device for esophageal cancer surgery anastomosis healing according to claim 1, characterized in that: The esophageal positioning capsule has a diameter of 18 mm after being inflated, and the diameter of the gastric positioning capsule after being inflated is determined according to the diameter of the stomach at the location where it is placed.

6. The hyperoxia-environmental gastric tube device for esophageal cancer surgery anastomosis healing according to claim 1, characterized in that: It also includes a positioning imaging strip, which passes through the gastric positioning capsule and is positioned on the side wall of the main tube. One end of the positioning imaging strip is positioned below the oxygen outlet and the other end is positioned at the distal end of the main tube. The positioning imaging strip appears as a bright image under X-ray imaging and is used to check whether the position of the oxygen outlet corresponds to the position of the anastomosis after esophageal cancer surgery.

7. The hyperoxia-environmental gastric tube device for esophageal cancer surgery anastomosis healing according to claim 1, characterized in that: The expanded section has an olive-shaped structure, with its diameter gradually decreasing from the middle to both ends, and its two ends are connected to the outer wall of the main tube in a transitional sealing connection.

8. A dynamic control method for a hyperoxia-environment gastric tube device for anastomotic healing after esophageal cancer surgery, characterized in that, The hyperoxia-environmental gastric tube device for esophageal cancer postoperative anastomosis healing as described in claim 1, wherein the dynamic control method includes the following steps: S1. Preoperative assessment: Preoperative assessment of the patient's postoperative anastomosis location, intrathoracic pressure, and lung function to rule out contraindications to hyperoxia; S2. Equipment preparation: Select a suitable high-oxygen release gastric tube device according to the patient's esophageal diameter and anastomosis location. The distance between the esophageal positioning capsule and the gastric positioning capsule should cover the upper and lower ends of the anastomosis by 2-3 cm. Install pressure sensors in the infusion tube and the oxygenation tube to monitor the air pressure in the positioning capsule and the oxygenation tube. Install an oxygen flow meter on the oxygenation connector. S3. Precise intraoperative tube placement and positioning: With the assistance of X-ray imaging, the hyperoxia-release gastric tube device is implanted into the patient's esophagus, with the oxygen outlet aligned with the anastomosis. Water or air is injected into the lumen of the positioning capsule through the infusion tube to a set pressure value P, fixing the positioning capsule in the preset position. The infusion valve is then closed to maintain stable pressure within the positioning capsule, thus completing the positioning of the hyperoxia-release gastric tube device. The range of pressure fluctuations within the positioning capsule is determined by the patient's lung function test data and satisfies the following relationship: ΔP=μ1·FEV1+μ2·FVC In the formula, ΔP is the pressure fluctuation range inside the positioning bag, FEV1 is the amount of gas exhaled in the first second of the patient's forced exhalation, reflecting the patency of the airway and ventilation function, FVC is the total amount of gas exhaled as quickly as possible after the patient's maximum inhalation, reflecting the elastic recoil force of the lungs and the patency of the airway, and μ1 and μ2 are the weighting coefficients of FEV1 and FVC, respectively. S4. Dynamic control of postoperative hyperoxia environment: The oxygen supply connector is connected to the oxygen supply system. Initial oxygen parameters are set in the oxygen supply system, including oxygen flow rate Q and oxygen concentration c. The oxygen supply switch valve is opened, and oxygen is delivered to the oxygen outlet through the oxygen supply tube to continuously release oxygen to the anastomosis and its surrounding area, forming a local hyperoxia microenvironment. The changes in blood oxygen saturation SpO2 of the anastomosis and its surrounding tissues are monitored in real time by the blood oxygen saturation monitoring sensor. The oxygen flow rate Q and oxygen concentration c are adjusted according to the monitoring data. S5. Management of esophageal and gastric secretions: The proximal end of the esophageal suction tube is continuously connected to the negative pressure component, which continuously suctions saliva and exudate accumulated on the esophageal positioning sac; the proximal gap of the main tube is connected to the negative pressure component, and the gap suctions gastric juice refluxed from the stomach. S6. Nutritional support: Nutritional fluid is delivered to the stomach through the main tube according to the patient's nutritional needs; S7. Healing Index Assessment: The healing index is the stiffness E of the healing site tissue. A high-frequency ultrasound probe is used to scan the anastomosis area, emitting shear waves and measuring the propagation velocity v. s Calculate the stiffness E of the anastomotic tissue, satisfying the following relationship: E=3ρv s 3 Where ρ is the density of the anastomosing tissue, in g / cm³. 3 By using CT scans of the anastomosis area and quantifying the healing index (AHI) through 3D modeling, the healing status of the anastomosis can be assessed. The healing index AHI satisfies the following relationship: The healing criteria are: the stiffness of the anastomotic tissue E ≤ 50 kPa and the healing index AHI ≥ 95%; S8. Tube Removal: Once the healing criteria are met, completely release the pressure of the positioning bag and stop oxygen delivery, then remove the hyperoxia gastric tube device.

9. The dynamic control method for the hyperoxia-environment gastric tube device for esophageal cancer surgery anastomosis healing according to claim 8, characterized in that: In step S4, the oxygen parameters are adjusted based on multi-sensor fusion monitoring data. The oxygen saturation data monitored by the oxygen saturation monitoring sensor located above the esophageal positioning pouch is (SpO2)1; the oxygen saturation data monitored by the oxygen saturation monitoring sensor located below the gastric positioning pouch is (SpO2)2; and the oxygen saturation data monitored by the oxygen saturation monitoring sensor located on the side wall of the dilation segment is (SpO2)3. The overall oxygen saturation data (SpO2) is calculated based on the weights of each oxygen saturation monitoring sensor. 综合 It satisfies the following relationship: (SpO2) 综合 =γ1·(SpO2)1+γ2·(SpO2)2+γ3·(SpO2)3 In the formula, γ1, γ2, and γ3 are weighting coefficients, which are used to synthesize blood oxygen saturation data (SpO2). 综合 When the oxygen level is less than 92%, an alarm is triggered to remind the operator to adjust the oxygen parameters of the oxygen supply system and increase the oxygen flow rate by 0.5 L / min.

10. The dynamic control method for the hyperoxia environment gastric tube device for esophageal cancer surgery anastomosis healing according to claim 8, characterized in that... Step S4 uses a PID algorithm to regulate oxygen parameters, including the following steps: S401. Calculate the error between the real-time SpO2 value and the target value of blood oxygen saturation data: Calculate the error e(t) between the real-time SpO2 value monitored by the blood oxygen saturation monitoring sensor installed on the side wall of the expanded section and the target value, satisfying the following relationship: e(t) = SpO2' - SpO2 In the formula, SpO2' is the target value of blood oxygen saturation data, and SpO2 is the real-time value of blood oxygen saturation data; when e(t) max When |e(t)|>0, it is necessary to adjust the oxygen parameters using a PID algorithm and continuously monitor changes in blood oxygen saturation data (SpO2); where e(t) max This is the threshold value for exceeding the limit; when |e(t)| > e(t). max When this occurs, the emergency brake is triggered, and medical staff are notified to check the equipment status and the patient's physiological indicators. S402. Initialize PID parameters: Initialize and set the parameters of the PID algorithm, including the proportional constant K. p Integral constant K i Differential constant K d ; S403. Calculate the control quantity based on the PID algorithm: In the formula, Output(t) is the PID output value, and K p K is a proportionality constant. i K is the integration constant. d is a differential constant; where the output limit is the oxygen flow rate Q within the adjustment range of 0.5 L / min to 5 L / min, and the oxygen concentration c within the adjustment range of 21% to 100%; S404. Adjusting Oxygen Parameters: Based on the bivariate collaborative control strategy, oxygen flow rate Q is set as the primary control variable, and oxygen concentration c is set as the compensation variable. The target blood oxygen saturation SpO2' is achieved primarily by adjusting the oxygen flow rate Q. The adjustment rules are as follows: When Output(t) > 0, the PID output value is positive, indicating that the current real-time blood oxygen saturation data SpO2 is lower than the target value, and the oxygen flow rate needs to be increased to improve oxygen supply. Q' = Q0 + output(t)·α When Output(t) < 0, the PID output value is negative, indicating that the current real-time blood oxygen saturation data SpO2 is higher than the target value, and the oxygen flow rate needs to be reduced to avoid over-oxygen supply. Q' = Q0 - |output(t)|·α In the formula, Q' is the adjusted oxygen flow rate, Q0 is the initial oxygen flow rate, and α is the proportional coefficient, which is used to control the sensitivity of the oxygen flow rate adjustment. When the oxygen flow rate Q is adjusted to its limit but still cannot meet the target blood oxygen saturation SpO2', the concentration compensation mechanism is activated. The target blood oxygen saturation SpO2' is achieved by adjusting the oxygen concentration c. The adjustment rules are as follows: When the adjusted oxygen flow rate Q' = Qmax and e(t) > 0, the oxygen flow rate has reached its upper limit, but the real-time blood oxygen saturation data SpO2 is still lower than the target value. Therefore, the oxygen concentration c needs to be increased to enhance the oxygen delivery efficiency per unit flow rate. c' = c0 + output(t)·β When the adjusted oxygen flow rate Q' = Qmin and e(t) < 0, the oxygen flow rate has reached the lower limit, but the real-time blood oxygen saturation data SpO2 is still higher than the target value, so the oxygen concentration c needs to be reduced to decrease oxygen supply. c' = c0 - |output(t)|·β In the formula, c' is the adjusted oxygen concentration, c0 is the initial oxygen concentration, and β is the compensation coefficient, which is used to control the magnitude of oxygen concentration adjustment. S405. Real-time monitoring and adaptive optimization: Collect real-time SpO2 data every 5 seconds, update the error e(t) and PID output, record the effect curves of the adjusted oxygen flow rate Q' and oxygen concentration c' on SpO2, and continuously optimize the PID parameters in step S402.

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