Pressure-controllable super-high-oxygen myocardial perfusion device and pressure control method

Abstract

The present application relates to the technical field of interventional medical instruments, in particular to a pressure-controllable super-high-oxygen myocardial perfusion device and a pressure control method. The device comprises a normal-pressure oxygenation cavity, a heat exchange cavity and a high-pressure oxygenation cavity connected in sequence, and a main circulation loop and a static high-pressure oxygenation bypass; the inlet and outlet of the high-pressure oxygenation cavity are both provided with a blockage type peristaltic pump with pumping and sealing functions, the peristaltic pump is internally provided with an oxygenation membrane, and is configured with a pressurizing mechanism for simultaneously pressurizing liquid sides and oxygen sides on both sides of the oxygenation membrane, and a heat exchange mechanism for cooling the perfusion liquid to about 14 DEG C. The present application can prepare super-high-oxygen myocardial protective liquid with oxygen partial pressure higher than 700 mmHg through static, low-temperature and high-pressure oxygenation while maintaining extracorporeal circulation continuous perfusion, significantly improve the myocardial protection effect, and has the advantages of compact structure, precise control and safe operation.

Description

Technical Field

[0001] This invention patent relates to the field of interventional medical device technology, specifically to a pressure-controllable hyperoxia myocardial perfusion device and pressure control method. Background Technology

[0002] In current cardiac surgery using cardiopulmonary bypass, the use of cardioprotective solutions is crucial for maintaining the survival and functional integrity of myocardial cells during cardiac arrest. While traditional cardioplegic solutions containing blood can provide some oxygen supply, their oxygen partial pressure is typically maintained within the range of 150-300 mmHg, which is insufficient to meet the myocardial metabolic oxygen demand during hypothermic cardioplegia, easily leading to myocardial ischemia-reperfusion injury and affecting postoperative cardiac function recovery. In current technology, the preparation and delivery of cardioprotective solutions mainly rely on membrane oxygenators integrated into the cardiopulmonary bypass machine and conventional peristaltic pump perfusion systems. These devices aim to achieve continuous, normobaric oxygenation and systemic perfusion of blood. Their oxygenation units typically operate at atmospheric pressure, achieving oxygen diffusion through gas exchange membranes. The achieved oxygen partial pressure is limited by physical laws and difficult to exceed conventional ranges. Their perfusion subsystems focus on maintaining stable blood flow and pressure, lacking functional modules for targeted enhanced oxygenation of blood under high pressure, hypothermia, and static conditions.

[0003] In recent years, supersaturated oxygen (SSO2) technology, originating from cardiology, has provided a novel approach to increasing local oxygen partial pressure. According to pivotal studies such as AMIHOT II and IC-HOT, this system can significantly increase the partial pressure of liquid oxygen to levels (>760 mmHg) that are difficult to achieve with conventional blood oxygenation. Immediately after percutaneous coronary intervention in patients with acute ST-segment elevation myocardial infarction, local coronary perfusion of this supersaturated oxygenated solution via a dedicated catheter has been shown to effectively reduce the infarct size and has resulted in significant improvements in left ventricular function during follow-up.

[0004] However, the perfusion system currently relied upon by this technology is designed specifically for short-term, targeted percutaneous coronary perfusion in the context of a cardiology catheterization lab. Its operating mode requires the patient to remain supine in the catheterization lab after PCI, receiving approximately 60 minutes of hyperoxic fluid perfusion via an indwelling coronary catheter. This system suffers from a fundamental contradiction in its design logic with cardiac surgery: it lacks an interface for working with cardiopulmonary bypass, making it unable to process shunt blood in batches while maintaining continuous systemic blood flow perfusion; its pressure control and circulation pathway are not designed to be compatible with cardioplegic solutions, and it cannot meet the need for multiple, intermittent hyperoxic perfusions that may be required during surgery. Therefore, although experimental hyperoxic technologies and prototype devices have been validated in the field of cardiology, the entire system is neither directly transplanted nor applicable to the cardiopulmonary bypass surgery scenario in cardiac surgery in terms of principle and design. Currently, the field of cardiac surgery still lacks a dedicated perfusion device that can be seamlessly integrated with cardiopulmonary bypass and can safely and controllably prepare and deliver hyperoxia myocardial protective fluid under continuous systemic perfusion.

[0005] Based on the aforementioned clinical needs and technological gaps, the applicant proposed a pressure-controllable hyperoxia myocardial perfusion device. Through a dual-loop system that coordinates the main circulation and the hyperbaric oxygenation bypass, it achieves the safe preparation and delivery of hyperoxia myocardial protective fluid under continuous extracorporeal circulation. Summary of the Invention

[0006] The purpose of this invention is to provide a pressure-controllable hyperoxia myocardial perfusion device and pressure control method. While the main circulation is continuously perfused, the device independently processes the shunt perfusion fluid through a high-pressure oxygenation chamber. The pressurization mechanism is used to synchronously increase and stably maintain the oxygen partial pressure and liquid pressure above 800 mmHg, thereby efficiently preparing hyperoxia myocardial protective fluid under closed conditions. Through a controlled pressure release and delivery mechanism, it achieves safe and precise perfusion in cardiac surgery.

[0007] The present invention is implemented as follows: a pressure-controllable hyperoxia myocardial perfusion device, comprising a device body, characterized in that the device body has an atmospheric pressure oxygenation chamber and a hyperoxia chamber, which are connected in series by pipelines, and both chambers are provided with oxygenation membrane cloth; both the inlet and outlet ends of the hyperoxia chamber are provided with a stop-type peristaltic pump. The device body is equipped with an atmospheric pressure oxygen chamber and a high pressure oxygen chamber that are connected to two sets of oxygenation membrane fabrics. The inlet and outlet of the atmospheric oxygenation chamber are connected to a drainage pipe and a bypass pipe, respectively, and a circulating peristaltic pump is installed on the drainage pipe; the outlet of the high-pressure oxygenation chamber is connected to the bypass pipe, and a three-way valve is provided at this connection node. The three-way valve is also connected to an injection pipe. By controlling the three-way valve, the basic injection solution and the ultra-high pressure oxygenation injection solution can be switched for injection. A pressure plate is provided in a sealed sliding position inside the high-pressure oxygenation chamber; a pressure mechanism is provided on the main body of the device, which can drive the pressure plate to pressurize the blood side of the oxygenation membrane cloth, and at the same time, the pressure mechanism also pressurizes the oxygen side of the oxygenation membrane cloth. The device also includes a heat exchange mechanism, which is used to regulate the temperature of the blood to a specified range. Pressure sensors are installed in both the high-pressure oxygen chamber and the high-pressure oxygenation chamber. Temperature sensors and oxygen partial pressure sensors are also installed in the high-pressure oxygenation chamber.

[0008] Furthermore, the heat exchange mechanism is a refrigeration semiconductor.

[0009] Furthermore, the heat exchange mechanism also includes heat exchange coils.

[0010] Furthermore, the pressurization mechanism includes a blood-side mechanical pressurization unit and an oxygen-side pressure control unit; a stable high-pressure environment is established and maintained on both sides of the oxygenation membrane filament to drive oxygen to dissolve in the blood under high pressure, thereby generating ultra-high oxygen perfusion fluid; the device body is also equipped with a heat exchange chamber filled with heat-conducting fluid, the cooling end of the cooling semiconductor and the heat exchange coil are installed in the heat exchange chamber, and the two ends of the heat exchange coil are connected to the atmospheric pressure oxygenation chamber and the high pressure oxygenation chamber, respectively.

[0011] Furthermore, the blood-side mechanical pressurization unit includes a sleeve, a lead screw, and a servo motor; the top of the pressure plate is fixedly connected to the bottom of the sleeve, the sleeve is fitted onto the threaded section of the lead screw, and the top of the lead screw is fixedly connected to the output end of the servo motor.

[0012] Furthermore, the oxygen-side pressure control unit includes a pneumatic pump and two gas supply pipes; the pneumatic pump can be connected to an external oxygen source, and the outlet of the pneumatic pump is connected to both gas supply pipes. The outlets of the two gas supply pipes are respectively connected to the atmospheric pressure oxygen chamber and the high pressure oxygen chamber, and both gas supply pipes are equipped with solenoid valves.

[0013] Furthermore, the pressurization mechanism includes a cylinder, a pressurization piston, two intake pipes, an exhaust pipe, a two-way valve, two pressurization pipes, two one-way valves, and a reciprocating drive unit. The cylinder is fixedly mounted on the device body, and the pressurization piston is slidably disposed within the cylinder. The power output end of the reciprocating drive unit is connected to the pressurization piston and drives the pressurization piston to reciprocate along the cylinder. The end of the cylinder is connected to both the intake pipe and the exhaust pipe, and the two one-way valves are respectively installed in the intake pipe and the exhaust pipe. The exhaust pipe is connected to the two pressurization pipes via the two-way valve, and the ends of the two pressurization pipes away from the two-way valve are respectively connected to the high-pressure oxygen chamber and the high-pressure oxygenation chamber. A cooling semiconductor is embedded in the pressurization plate for directly cooling the blood.

[0014] Furthermore, the reciprocating drive unit includes a second motor, a rotating disk, a connecting rod, a slider, and a limiting groove; the limiting groove is fixedly installed at the end of the cylinder, the slider is slidably disposed in the limiting groove, and one end of the slider is connected to the pressurizing piston through a rod body; both ends of the connecting rod are hinged to the slider and the surface of the rotating disk, respectively; the output end of the second motor is fixedly connected to the axis of the rotating disk.

[0015] Furthermore, the interrupted peristaltic pump includes a housing, a motor, a hollow shaft, a hydraulic drive unit, and multiple sets of rolling telescopic units. The output end of the motor is connected to the hollow shaft. Multiple sets of rolling telescopic units are installed on the outer wall of the hollow shaft at equal arc length intervals. The hydraulic drive unit is installed on the hollow shaft. A sealed chamber filled with hydraulic oil is formed between the hollow shaft, the hydraulic drive unit, and the multiple sets of rolling telescopic units. The hydraulic drive unit controls the extension and retraction length of the multiple sets of rolling telescopic units through hydraulic transmission, thereby realizing continuous adjustment of the extrusion intensity during pumping and completely compressing the connecting pipe during non-pumping stages to ensure the sealing and isolation of the high-pressure oxygenation chamber.

[0016] This invention also provides a pressure control method for preparing hyperoxia myocardial perfusion solution, characterized in that the method is applied in any one of the hyperoxia myocardial perfusion devices according to claims 1-9; the specific method is as follows: S1: After the base fluid is injected into the high-pressure oxygenation chamber, the controller controls the blocking peristaltic pump located at the inlet and outlet of the high-pressure oxygenation chamber to close the corresponding pipeline, so that the high-pressure oxygenation chamber forms a closed chamber. S2: The controller drives the pressurization mechanism to operate, simultaneously pressurizing the liquid and gas sides of the oxygenation membrane cloth in the high-pressure oxygenation chamber, and monitoring the pressure data of the pressure sensors in the high-pressure oxygenation chamber and the high-pressure oxygen chamber in real time. S3: When the pressure data fed back by the pressure sensor reaches the preset target pressure value, the controller controls the pressurization mechanism to switch to the pressure maintenance mode in order to maintain the dynamic pressure balance on both sides of the oxygenation membrane. S4: The controller continuously receives oxygen partial pressure data monitored by the oxygen partial pressure sensor. When the oxygen partial pressure data reaches the preset ultra-high oxygenation threshold, the controller starts pressure relief and controls the pressurization mechanism to gradually reduce the pressure in the high-pressure oxygenation chamber and oxygen chamber according to the set time interval and pressure gradient. S5: After the pressure drops to normal pressure, the controller adjusts the blocking peristaltic pump at the outlet of the high-pressure oxygenation chamber to open the outlet pipeline and deliver the prepared ultra-high oxygenation infusion solution to the infusion pipeline through the pump.

[0017] Compared with the prior art, the present invention has the following beneficial effects: 1. This device, through a dual-loop system consisting of a continuous perfusion main loop and a static high-pressure processing module, ensures uninterrupted extracorporeal circulation while simultaneously maintaining the blood and oxygen sides in a high-pressure environment (approximately 800 mmHg) and achieving static high-efficiency oxygenation at low temperatures (approximately 14°C). This allows for the safe and controllable preparation of a hyperoxia myocardial protective solution with significantly increased oxygen partial pressure, systematically resolving the key contradiction in traditional perfusion methods that makes it difficult to coordinate continuous and efficient oxygenation with operational safety.

[0018] 2. This device embeds a cooling semiconductor inside the pressure plate, with the cold and hot ends of the semiconductor facing opposite sides of the pressure plate. This design, on the one hand, actively cools the injection fluid simultaneously during pressurization via the cold end, thereby increasing the solubility of oxygen in the injection fluid; on the other hand, it heats the pressurized oxygen driving the pressure plate using the hot end, increasing its temperature and pressure. This achieves the same pressurization effect while reducing oxygen consumption, realizing the synergistic utilization of heat and pressure and overall optimization of system energy efficiency.

[0019] 3. This device is equipped with a three-way valve (V2) at the junction of the exhaust pipe and the two pressurizing pipes. This valve allows pressurized oxygen to simultaneously enter the high-pressure oxygenation chamber and the high-pressure oxygen chamber during the initial pressurization phase, achieving synchronous pressurization of the blood side and oxygen side of the oxygenation membrane fabric. During the pressure fine-tuning phase, by switching the three-way valve (V2), pressurized oxygen can enter either the high-pressure oxygenation chamber or the high-pressure oxygen chamber separately, enabling independent and precise adjustment of the pressure on both sides. Furthermore, by switching the three-way valve (V2), the gas space above the pressurizing plate in the high-pressure oxygenation chamber can be connected to the high-pressure oxygen chamber, thereby rapidly balancing the pressure in the two chambers and ensuring stable and efficient high-pressure oxygenation under minimal pressure difference conditions.

[0020] 4. The stop-type peristaltic pump in this device constructs a sealed hydraulic chamber by integrating a hollow rotating shaft with multiple sets of rolling telescopic units. A hydraulic drive unit is integrated on the hollow rotating shaft, allowing for precise control of the radial extension length of each rolling telescopic unit via hydraulic transmission. This design enables the peristaltic pump not only to pump the injection fluid at an adjustable intensity but also to directly close the connecting pipe between the inlet and outlet of the high-pressure oxygenation chamber when needed, thereby quickly forming a completely sealed, independent treatment chamber.

[0021] 5. This device is equipped with a three-way valve at the junction of the bypass pipe, the infusion pipe, and the high-pressure oxygenation chamber outlet pipe. By controlling the conduction path of this valve, on the one hand, during batch processing in the high-pressure oxygenation chamber, the infusion solution after atmospheric oxygenation can be continuously refluxed through the bypass pipe to maintain the main circulation infusion; on the other hand, when the batch preparation is completed, the path can be switched to close the bypass pipe, and the prepared ultra-high oxygenation infusion solution can be output directionally through the infusion pipe, while preparing for the next batch of infusion solution to enter the high-pressure oxygenation chamber, thereby achieving the timing connection and process continuity of preparation and infusion. Attached Figure Description

[0022] Figure 1 This is a schematic diagram of a pressure-controllable hyperoxia myocardial perfusion device provided in Embodiment 1 of the present invention; Figure 2 This is a top view of a pressure-controllable hyperoxia myocardial perfusion device provided in Embodiment 1 of the present invention; Figure 3 This is a side sectional view of the high-pressure oxygenation chamber provided in Embodiment 1 of the present invention; Figure 4 This is a front sectional view of the blocking peristaltic pump provided in Embodiment 1 of the present invention; Figure 5 This is a side sectional view of the blocking peristaltic pump provided in Embodiment 1 of the present invention; Figure 6 This is a block diagram of the control system provided in Embodiment 1 of the present invention; Figure 7 This is a top view of a pressure-controllable hyperoxia myocardial perfusion device provided in Embodiment 2 of the present invention; Figure 8 This is a side sectional view of the high-pressure oxygenation chamber provided in Embodiment 2 of the present invention; Figure 9 This is a schematic diagram of the structure of the three-way valve II provided in Embodiment 2 of the present invention; Figure 10 This is a schematic diagram of a pressure-controllable hyperoxia myocardial perfusion device provided in Embodiment 3 of the present invention; Figure 11 This is a side sectional view of the high-pressure oxygenation chamber provided in Embodiment 3 of the present invention.

[0023] Reference numerals used in the above figures: 1. Atmospheric pressure oxygenation chamber; 2. Atmospheric pressure oxygen chamber; 3. Refrigeration semiconductor; 4. Device body; 5. Heat exchange coil; 6. Heat exchange chamber; 7. Connecting pipe; 8. Shell; 9. Roller; 10. Telescopic rod; 11. Pressure sensor; 12. High pressure oxygen chamber; 13. High pressure oxygenation chamber; 14. Oxygenation membrane fabric; 15. Exhaust pipe; 16. Three-way valve; 17. Bypass pipe; 18. Injection pipe; 19. Circulating peristaltic pump; 20. Drainage pipe; 21. Servo 21. Servo motor; 22. Solenoid valve; 23. Air pump; 24. Air supply pipe; 25. Lead screw; 26. Sleeve; 27. Pressure plate; 28. Motor 1; 29. ​​Extrusion piston; 30. Stepper motor; 31. Threaded rod; 32. Hollow rotating shaft; 33. Air inlet pipe; 34. Connecting rod; 35. Rotating disk; 36. Limiting groove; 37. Cylinder; 38. Slider; 39. Pressure piston; 40. Three-way valve 2; 41. Motor 2; 42. Pressure pipe. Detailed Implementation

[0024] To make the objectives, technical solutions, and advantages of this invention clearer, the invention will be further described in detail below with reference to the accompanying drawings and embodiments. It should be understood that the specific embodiments described herein are merely illustrative and not intended to limit the invention.

[0025] The implementation of the present invention will be described in detail below with reference to specific embodiments.

[0026] In the accompanying drawings of this embodiment, the same or similar reference numerals correspond to the same or similar components. In the description of this invention, it should be understood that if terms such as "upper," "lower," "left," and "right" indicate the orientation or positional relationship based on the orientation or positional relationship shown in the accompanying drawings, they are only for the convenience of describing this invention 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, the terms used to describe positional relationships in the accompanying drawings are only for illustrative purposes and should not be construed as limiting this patent. For those skilled in the art, the specific meaning of the above terms can be understood according to the specific circumstances.

[0027] Reference Figure 1-11 The image shown is a preferred embodiment of the present invention.

[0028] Example 1: A pressure-controllable hyperoxia myocardial perfusion device. The main body of the device is a plate-like structure, with an atmospheric pressure oxygenation chamber 1, a heat exchange chamber 6, and a hyperbaric oxygenation chamber 13 arranged sequentially inside. The atmospheric pressure oxygenation chamber 1 is used to oxygenate and decarbonate blood drawn from the patient's vein at atmospheric pressure to form the perfusion base solution. The heat exchange chamber 6 is equipped with a heat exchange mechanism that can lower the temperature of the perfusion base solution to about 14°C to improve the physical solubility of oxygen and prepare for subsequent hyperbaric oxygenation. In the hyperbaric oxygenation chamber 13, high pressure is applied synergistically to the oxygen side and blood side of the oxygenation membrane fabric 14, significantly increasing the oxygen solubility under low temperature conditions, thereby preparing the hyperoxia myocardial perfusion solution.

[0029] The following will further explain the specific structures of the atmospheric oxygenation chamber 1, the heat exchange chamber 6, and the high-pressure oxygenation chamber 13.

[0030] like Figure 1 As shown, an oxygenation membrane cloth 14 is provided in the atmospheric oxygenation chamber 1. To provide oxygen at a stable pressure to the oxygenation membrane cloth 14, an atmospheric oxygen chamber 2 is provided on the outside of the device body 4 corresponding to the atmospheric oxygenation chamber 1, and the air inlet end of the oxygenation membrane cloth 14 is located in the atmospheric oxygen chamber 2. When blood drawn from the patient's venous system enters the atmospheric oxygenation chamber 1, it can be oxygenated by contact with the oxygen overflowing through the oxygenation membrane cloth 14, and carbon dioxide is removed simultaneously.

[0031] Combination Figure 2As shown, a drainage tube 20 is connected to the top of the normobaric oxygenation chamber 1. A peristaltic pump 19 is installed on the drainage tube 20 to pressurize and deliver the patient's venous blood to the normobaric oxygenation chamber 1. To maintain continuous oxygenation and reinfusion of the basal perfusion solution during the preparation of hyperoxia myocardial perfusion solution, a bypass tube 17 is connected to the side wall of the normobaric oxygenation chamber 1 in this embodiment. A T-shaped three-way valve (i.e., three-way valve 16) is installed at the end of the bypass tube 17, which is also connected to a perfusion tube 18. When the device is in conventional oxygenation mode, the basal perfusion solution formed after oxygenation can be returned to the patient's arterial system via the bypass tube 17 and the perfusion tube 18, thus forming a continuously operating main circulation perfusion loop. To monitor and control the pressure of the perfusion solution infused into the patient's artery in real time, a perfusion pressure sensor (not shown separately in the figure) is integrated into the perfusion tube 18 in this embodiment. The sensor is preferably installed on the infusion tubing 18 near the patient connection end, with its sensing diaphragm in direct contact with the infusion fluid within the tubing, enabling accurate sensing of the infusion fluid pressure. The signal output of the infusion pressure sensor is connected to the controller.

[0032] To significantly improve oxygen dissolution efficiency through temperature regulation during the preparation of hyperoxia myocardial perfusion solution, this device incorporates a heat exchange mechanism in heat exchange chamber 6. For example... Figure 1 As shown, the heat exchange chamber 6 is a sealed cavity filled with a heat-conducting medium (such as medical-grade silicone oil or ethylene glycol solution). The heat exchange mechanism mainly consists of a cooling semiconductor 3 and a heat exchange coil 5: the cooling semiconductor 3 is embedded in the bottom surface of the heat exchange chamber 6, with its cold end extending into the heat exchange chamber 6 to cool the heat-conducting medium; its hot end is located on the outside of the cavity and connected to a heat dissipation structure (not shown in the figure) to ensure effective heat dissipation. The operation of the cooling semiconductor 3 can stably maintain the temperature of the heat-conducting medium below 14°C.

[0033] The heat exchange coil 5 is installed inside the heat exchange chamber 6 and immersed in the heat transfer medium. One end of the coil is connected to the atmospheric pressure oxygenation chamber 1, and the other end is connected to the high pressure oxygenation chamber 13 via the connecting pipe 7. A stop-type peristaltic pump is installed on the connecting pipe 7 to pump the basic injection fluid output from the atmospheric pressure oxygenation chamber 1 into the heat exchange coil 5, and achieves cooling through heat exchange between the coil wall and the low temperature heat transfer medium during the flow process.

[0034] To further precisely control the temperature of the injection fluid entering the high-pressure oxygenation chamber 13, a temperature sensor is installed at the outlet of the heat exchange coil 5. When the outlet temperature is detected to be higher than the set value (14℃), the controller adjusts the power of the cooling semiconductor 3 according to the PID algorithm to enhance the cooling effect, thereby ensuring that the temperature of the injection fluid is stably maintained at 14℃±0.5℃ when it flows out of the heat exchange coil 5. This temperature control mechanism provides the necessary low-temperature environment for achieving high dissolved oxygen levels in the subsequent high-pressure oxygenation stage.

[0035] To provide stable high-pressure oxygen to the oxygenation membrane filament 14 within the high-pressure oxygenation chamber 13, a high-pressure oxygen chamber 12 is provided outside the corresponding high-pressure oxygenation chamber 13, with the air inlet end of the oxygenation membrane filament 14 located within this chamber. Pressure sensors 11 are installed in both the high-pressure oxygen chamber 12 and the high-pressure oxygenation chamber 13 to monitor the pressure on both sides in real time. To achieve coordinated high pressure on both sides of the oxygenation membrane filament 14 (liquid side and oxygen side), such as... Figure 3 As shown, a pressure plate 27 is slidably and sealed inside the high-pressure oxygenation chamber 13. The pressure plate 27 divides the chamber into upper and lower chambers: the injection fluid enters the lower chamber of the pressure plate 27 through the connecting pipe 7. The upper chamber is the pressure chamber that controls the downward movement of the pressure plate 27.

[0036] The pressurization mechanism in this embodiment consists of a blood-side mechanical pressurization unit and an oxygen-side pressure control unit. The blood-side mechanical pressurization unit mainly comprises a servo motor 21, a lead screw 25, and a sleeve 26. The servo motor 21 is fixedly mounted on the top of the device body 4, and its output shaft is connected to the top of the lead screw 25. The bottom of the sleeve 26 is fixedly connected to the top surface of the pressure plate 27 and threaded onto the threaded section of the lead screw 25. When the servo motor 21 drives the lead screw 25 to rotate, the sleeve 26 drives the pressure plate 27 to slide downward along the cavity wall, applying mechanical pressure to the perfusion fluid in the lower cavity. As the pressure plate 27 continues to press down, the liquid is compressed, and the pressure rises rapidly. When the pressure sensor 11 detects that the liquid-side pressure reaches the set value (800 mmHg), the controller commands the servo motor 21 to stop. Based on the self-locking characteristic of the lead screw 25 transmission, the system can maintain this pressure stability without continuous power input.

[0037] Oxygen-side pressure control unit such as Figure 2 As shown, it mainly consists of a pressure pump 23 and two gas supply pipes 24. The pressure pump 23 is connected to an external oxygen source, and its outlet is split and connected to the atmospheric pressure oxygen chamber 2 and the high-pressure oxygen chamber 12 through the two gas supply pipes 24 respectively. Each gas supply pipe 24 is equipped with an independently controlled solenoid valve 22 to regulate the gas pressure of the two chambers respectively. During the high-pressure oxygenation process, the pressure pump 23 continuously supplies oxygen to the high-pressure oxygen chamber 12. The controller dynamically adjusts the output power of the pressure pump 23 and the opening of the corresponding solenoid valve 22 based on the feedback signal from the pressure sensor 11 in the chamber, so that the oxygen side pressure is also stably maintained at about 800 mmHg.

[0038] Therefore, the oxygenation membrane fabric 14 can maintain a balanced pressure environment of about 800 mmHg on both sides under low temperature (14℃) conditions, which not only greatly improves the physical solubility of oxygen, but also effectively avoids structural stress damage to the oxygenation membrane fabric 14 caused by excessive pressure difference, thus reliably and efficiently preparing ultra-high oxygen myocardial perfusion solution.

[0039] To ensure the hyperbaric oxygenation chamber 13 remains completely sealed during the preparation of hyperbaric myocardial perfusion solution, this device is equipped with a stop-type peristaltic pump at both its inlet and outlet ends. The specific structure of this pump is as follows: Figure 4 and Figure 5 As shown, it mainly consists of a housing 8, a motor 28, a hollow rotating shaft 32, a hydraulic drive unit, and three sets of rolling telescopic units evenly arranged along the circumference of the hollow rotating shaft 32. The motor 28 is fixedly mounted on the outer wall of the housing 8, and its output end is connected to one end of the hollow rotating shaft 32. Each rolling telescopic unit includes a hollow telescopic rod 10 and a rolling wheel 9 rotatably mounted at the telescopic end of the telescopic rod 10. The interior of the telescopic rod 10 communicates with the hollow rotating shaft 32, forming a hydraulic transmission path.

[0040] The hydraulic drive unit is integrated at the end of the hollow shaft 32 and consists of a stepper motor 30, a threaded rod 31, and a compression piston 29. The stepper motor 30 is fixedly mounted at the end of the hollow shaft 32, and its output shaft is connected to the threaded rod 31; the compression piston 29 is sleeved on the threaded rod 31. The space enclosed by the inner cavity of the telescopic rod 10, the interior of the hollow shaft 32, and the compression piston 29 together forms a sealed hydraulic chamber filled with hydraulic oil.

[0041] When the stepper motor 30 drives the threaded rod 31 to rotate, the compression piston 29 moves axially toward the center of the hollow rotating shaft 32, pushing hydraulic oil evenly into the inner cavity of each telescopic rod 10, thereby driving all telescopic rods 10 to extend radially synchronously. The extended rolling roller 9 presses the pump pipe shut, achieving a reliable seal of the pipeline. In this way, the high-pressure oxygenation chamber 13 can form a completely closed chamber under the action of two stop-type peristaltic pumps, providing the necessary sealing conditions for the subsequent high-pressure oxygenation process. The stop-type peristaltic pump can not only be used as a conventional pressurization device to deliver the injection fluid, but also as a valve structure to open or close the pipeline.

[0042] The perfusion device of this embodiment also provides a pressure control method for preparing hyperoxia myocardial perfusion solution. The specific method is as follows: S1: Routine perfusion phase: In normal myocardial perfusion mode, the controller sets the three-way valve 16 to the first position, connecting the bypass tube 17 to the perfusion tube 18. At this time, the blood drawn from the patient enters the normobaric oxygenation chamber 1 through the drainage tube 20, completing normobaric oxygenation and carbon dioxide removal. The resulting basal perfusion fluid is continuously returned to the patient through the bypass tube 17 and the perfusion tube 18 to maintain the main circulation perfusion.

[0043] S2: Start-up of preparation mode and pre-cooling: When it is necessary to prepare hyperoxia myocardial perfusion solution, the controller activates the cooling semiconductor 3 to cool the heat transfer fluid in the heat exchange chamber 6. After the temperature of the heat transfer fluid stabilizes to the set value (e.g., 14°C), the blocking peristaltic pump installed on the connecting pipe 7 starts, and delivers part of the basic perfusion solution in the atmospheric pressure oxygenation chamber 1 to the high pressure oxygenation chamber 13 after cooling through the heat exchange coil 5.

[0044] S3: Chamber Sealing and Pressure Establishment: When the injection fluid in the high-pressure oxygenation chamber 13 reaches the preset volume, the controller controls the synchronous operation of the stop-type peristaltic pumps at both the inlet and outlet ends, causing their rollers 9 to completely press against the pipeline, thereby sealing the high-pressure oxygenation chamber 13 into a sealed chamber. Subsequently, the controller synchronously starts the servo motor 21 and the air pump 23: the servo motor 21 drives the lead screw 25 to press down the pressure plate 27, applying pressure to the liquid side; the air pump 23 injects oxygen into the high-pressure oxygen chamber 12. The pressure sensors 11 of the two chambers monitor the pressure changes in real time until the pressure on both the liquid side and the oxygen side reaches the target value (e.g., 800 mmHg), at which point the controller causes the servo motor 21 and the air pump 23 to switch to pressure maintenance mode.

[0045] S4: High-Pressure Oxygenation and Pressure Relief: An oxygen partial pressure sensor continuously monitors the oxygen partial pressure in the perfusion fluid. When the oxygen partial pressure rises to a set target value (e.g., 760 mmHg), the controller initiates a pressure relief program: the servo motor 21 is controlled to rotate in the opposite direction at a gradient decrease of 50 mmHg every 5 minutes, gradually releasing the liquid-side pressure; the pneumatic pump 23 simultaneously stops supplying oxygen. During the pressure relief process, oxygen continuously dissolves into the perfusion fluid through the oxygenation membrane, causing the oxygen chamber pressure to decrease naturally. This gradient pressure relief process provides sufficient time for red blood cells to absorb dissolved oxygen, ensuring that the oxygen partial pressure in the perfusion fluid remains at a high level (e.g., not lower than 550 mmHg) after restoring normal pressure, thus completing the preparation of ultra-high oxygenation perfusion fluid.

[0046] S5: Perfusion Output and Circulation Recovery: After the hyperoxygenated perfusion solution is prepared, the controller starts the stop-type peristaltic pump at the outlet end and simultaneously switches the three-way valve 16 to the second position, connecting the perfusion tube 18 to the outlet tube of the hyperbaric oxygenation chamber 13, thereby directionally delivering the prepared hyperoxygenated perfusion solution to the patient. During this period, the blood newly entering the normobaric oxygenation chamber 1 is temporarily retained; after this batch of hyperoxygenated solution perfusion is completed, the three-way valve 16 returns to the first position, the main circulation perfusion restarts, and the retained blood, after cooling, enters the hyperbaric oxygenation chamber 13 to begin the next batch preparation cycle.

[0047] Example 2: A pressure-controllable hyperoxia myocardial perfusion device. This example provides a new pressurization mechanism compared to Example 1. The pressurization mechanism in this example uses a fully pneumatic pressurization method to achieve coordinated pressure control of the pressurization plate 27 and the high-pressure oxygen chamber 12.

[0048] Specifically, such as Figure 7 and Figure 8 As shown, the pressurization mechanism mainly includes a cylinder 37, a pressurization piston 39, an air circuit assembly, and a reciprocating drive unit. The cylinder 37 is fixedly installed on the top of the device body 4, with one end connected to two air circuits: an inlet pipe 33 and an exhaust pipe 15. Both pipes are equipped with flexible one-way valves. The one-way valve on the inlet pipe 33 allows oxygen to flow into the cylinder 37 in one direction, while the one-way valve on the exhaust pipe 15 allows gas to be discharged in one direction.

[0049] The pressurized piston 39 is slidably disposed in the cylinder 37 and reciprocates under the drive of the reciprocating drive unit: when the piston is drawn back, external oxygen is drawn into the cylinder 37 through the intake pipe 33; when the piston is pushed forward, the gas is discharged through the exhaust pipe 15.

[0050] The core of the pneumatic circuit assembly is the three-way valve 240, and its connection relationship is as follows: Figure 9 As shown: the exhaust pipe 15 and both pressurization pipes 42 are connected to this valve. The other ends of the two pressurization pipes 42 are respectively connected to the sealed chamber above the pressurization plate 27 and the high-pressure oxygen chamber 12. The three-way valve 40 has multiple flow modes, which can be switched via a controller: Synchronous pressurization mode: When the valve core is in the T-shaped connection state, the exhaust pipe 15 is simultaneously connected to the two pressurization pipes 42. At this time, the exhaust from the cylinder 37 can simultaneously pressurize the upper chamber of the pressurization plate 27 and the high-pressure oxygen chamber 12.

[0051] Independent pressure regulation mode: When it is necessary to adjust the pressure on both sides separately, the controller can switch the three-way valve 40 according to the feedback of the pressure sensor 11 in the high-pressure oxygenation chamber 13 and the high-pressure oxygen chamber 12, so that the exhaust pipe 15 is connected to only one of the pressurization pipes 42, thereby realizing the individual and precise pressurization of the liquid side or the oxygen side.

[0052] Pressure balance mode: By switching the valve position to directly connect the two pressurizing pipes 42, the pressure in the upper chamber of the pressurizing plate 27 and the high-pressure oxygen chamber 12 can be quickly balanced, and the pressure difference on both sides of the oxygenation membrane cloth 14 can approach zero.

[0053] With the help of the above-mentioned aerodynamic structure and control strategy, this embodiment can establish and maintain a stable high-pressure environment (such as 800 mmHg) on ​​both sides of the oxygenation membrane filament 14, which can improve the oxygenation efficiency while ensuring the safety of the membrane structure and the flexibility of system control.

[0054] To enable the pressurizing piston 39 to achieve high-speed and stable reciprocating motion to maintain continuous pressurization, this embodiment connects a reciprocating drive unit to the pressurizing piston 39. For example... Figure 7 and Figure 8As shown, this unit mainly consists of a second motor 41, a rotating disk 35, a connecting rod 34, a slider 38, and a limiting groove 36. The limiting groove 36 is fixedly installed at the end of the cylinder 37. The slider 38 slides back and forth along the groove and is connected to the pressurizing piston 39 through the rod body. The two ends of the connecting rod 34 are hinged to the surfaces of the slider 38 and the rotating disk 35, respectively. The output shaft of the second motor 41 is fixed to the center of the rotating disk 35. When the second motor 41 drives the rotating disk 35 to rotate, the connecting rod 34 drives the slider 38 to make linear reciprocating motion in the limiting groove 36, thereby driving the pressurizing piston 39 to reciprocate synchronously in the cylinder 37, realizing the continuous intake and exhaust of gas.

[0055] In addition, to ensure a continuous and sufficient supply of oxygen in the atmospheric pressure oxygen chamber 2, another intake pipe 33 is equipped with a solenoid valve 22 and is directly connected to an external oxygen source so that oxygen can be replenished in a timely manner when needed.

[0056] After the hyperoxia myocardial perfusion solution is prepared, in order to ensure that the pressure plate 27 can automatically return to its initial position, this embodiment has an electronic pressure relief valve (not shown in the figure) on the top of the device body 4, and a return spring (not shown in the figure) is installed on the top of the pressure plate 27. When the electronic pressure relief valve opens to release pressure, the restoring force of the return spring pulls the pressure plate 27 upward, so that it smoothly returns to its initial position, preparing for the next round of preparation.

[0057] The main difference between the pressure control method in this embodiment and that in Embodiment 1 is that the mechanical pressurization of the injection fluid is no longer controlled by the servo motor 21, but is achieved by adjusting the speed and direction of the motor 41. Furthermore, this method fully utilizes the multi-channel function of the three-way valve 40 to achieve dynamic pressure regulation and balance. The specific control logic is as follows: During the high pressure establishment and balancing stage: when the pressure in the upper chamber of the pressurizing plate 27 and the high-pressure oxygen chamber 12 both reach the target value (800 mmHg), the controller switches the three-way valve 2 40 to connect the two pressurizing pipes 42 individually, thereby achieving rapid pressure balancing between the two chambers and ensuring that the pressure difference on both sides of the oxygenation membrane approaches zero.

[0058] During the pressure maintenance and compensation phase: If the system detects that the total pressure is lower than the set threshold (e.g., 760 mmHg), the controller will switch the three-way valve 2 40 to the synchronous pressurization mode, so that the exhaust pipe 15 is connected to the two pressurization pipes 42 at the same time. The reciprocating motion of the cylinder 37 will perform synchronous pressure compensation on the two chambers until the target pressure is restored.

[0059] During the oxygenation target achievement and slow release phase: When the oxygen partial pressure sensor detects that the oxygen partial pressure of the perfusion fluid has risen to the target value (≥760 mmHg), the controller switches the three-way valve 2 40 again to connect the two pressurization pipes 42, maintain the pressure on both sides, and activate the electronic pressure relief valve to slowly release the system pressure at a controllable rate, ensuring that oxygen is fully dissolved in the perfusion fluid and avoiding oxygen escape or red blood cell damage due to a sudden drop in pressure.

[0060] It should be noted that the pressurizing mechanism protected by this application is not limited to the specific structural form described in the embodiments. Any pressurizing mechanism that can simultaneously and synergistically pressurize both sides (liquid side and oxygen side) of the oxygen membrane fabric 14 and stably maintain the total pressure on both sides within the set pressure range, regardless of its specific configuration or the mechanical, pneumatic, hydraulic or combined implementation method, shall be considered to fall within the protection scope of this application.

[0061] Example 3: A pressure-controllable hyperoxia myocardial perfusion device. Based on Example 2, this example optimizes the structure and arrangement of the heat exchange mechanism, eliminates the independent heat exchange chamber 6, and directly integrates the refrigeration semiconductor 3 into the pressure plate 27.

[0062] like Figure 10 and Figure 11 As shown, the cooling semiconductor 3 is embedded inside the pressure plate 27, with its cold end and hot end facing opposite sides of the pressure plate 27. This integrated design has a dual function: when the pressure plate 27 applies mechanical pressure to the injection fluid, the cold end directly and actively cools the injection fluid, thereby further increasing the solubility of oxygen under high pressure; at the same time, the hot end heats the oxygen (located in the upper chamber of the pressure plate 27) that drives the pressure plate 27, causing its temperature to rise and its pressure to increase accordingly.

[0063] During the preparation process, this structure can maintain the temperature of the perfusion fluid at a stable 14°C while pressurizing, ensuring a continuous high dissolved oxygen environment. Compared with the indirect heat exchange methods of Examples 1 and 2, although the cooling start-up of this example is slightly slower, the temperature control is more direct and stable, and the structure is more compact.

[0064] Furthermore, since the gas in the chamber above the pressure plate 27 is heated and its pressure increases, the amount of oxygen required to reach the same target pressure is reduced, thereby reducing oxygen consumption, improving gas utilization efficiency, and achieving system optimization through coordinated control of thermal energy and pressure.

[0065] The main difference between the pressure control method in this embodiment and that in embodiment 2 is that the gas temperature in the chamber above the pressure plate 27 continuously rises under the action of the hot end of the cooling semiconductor 3, causing dynamic changes in the chamber pressure. Therefore, the controller needs to dynamically adjust the output of the pressurizing mechanism based on the real-time feedback from the pressure sensor 11 in the high-pressure oxygenation chamber 13, and perform pressure fine-tuning in conjunction with the electronic pressure relief valve, thereby ensuring that the pressure on the oxygenation film liquid side is stably maintained within the target range of 800 mmHg.

[0066] It should be noted that the heat exchange mechanism protected by this application is not limited to the specific forms described in the above embodiments. Any heat exchange mechanism capable of cooling the injection fluid to meet the low-temperature control requirements in the high-pressure oxygenation process, regardless of its specific structural form, installation location, or heat exchange medium, shall be considered to fall within the protection scope of this application.

[0067] The above description is only a preferred embodiment of the present invention and is not intended to limit the present invention. Any modifications, equivalent substitutions, and improvements made within the spirit and principles of the present invention should be included within the protection scope of the present invention.

Claims

1. A pressure-controllable hyperoxia myocardial perfusion device, comprising a device body (4), characterized in that, The device body (4) has an atmospheric pressure oxygenation chamber (1) and a high pressure oxygenation chamber (13). The atmospheric pressure oxygenation chamber (1) and the high pressure oxygenation chamber (13) are connected in series through pipelines, and oxygenation membrane cloth (14) is provided inside the chambers. The inlet and outlet of the high pressure oxygenation chamber (13) are equipped with a blocking peristaltic pump. The main body of the device (4) is provided with an atmospheric pressure oxygen chamber (2) and a high pressure oxygen chamber (12) that are connected to two sets of oxygenation membrane fabrics (14); The inlet and outlet of the atmospheric oxygenation chamber (1) are connected to a drainage pipe (20) and a bypass pipe (17) respectively. A circulating peristaltic pump (19) is installed on the drainage pipe (20). The outlet of the high-pressure oxygenation chamber (13) is connected to the bypass pipe (17), and a three-way valve (16) is provided at the connection node. The three-way valve (16) is also connected to an injection pipe (18). By controlling the three-way valve (16), the basic injection solution and the ultra-high pressure oxygenation injection solution can be switched for injection. A pressure plate (27) is provided in the sealed sliding part of the high-pressure oxygenation chamber (13); a pressure mechanism is provided on the main body (4) of the device, which can drive the pressure plate (27) to pressurize the blood side of the oxygenation membrane cloth (14), and at the same time, the pressure mechanism also pressurizes the oxygen side of the oxygenation membrane cloth (14); The device body (4) is also equipped with a heat exchange mechanism, which is used to regulate the temperature of the blood to a specified range; Pressure sensors (11) are provided in both the high-pressure oxygen chamber (12) and the high-pressure oxygenation chamber (13). Temperature sensors and oxygen partial pressure sensors are also provided in the high-pressure oxygenation chamber (13).

2. The pressure-controllable hyperoxia myocardial perfusion device according to claim 1, characterized in that, The heat exchange mechanism is a refrigeration semiconductor (3).

3. The pressure-controllable hyperoxia myocardial perfusion device according to claim 2, characterized in that, The heat exchange mechanism also includes heat exchange coils (5).

4. The pressure-controllable hyperoxia myocardial perfusion device according to claim 3, characterized in that, The pressurization mechanism includes a blood-side mechanical pressurization unit and an oxygen-side pressure control unit; a stable high-pressure environment is established and maintained on both sides of the oxygenation membrane fabric (14) to drive oxygen to dissolve in the blood under high pressure, thereby generating ultra-high oxygen perfusion fluid; the device body (4) is also provided with a heat exchange chamber (6) filled with heat-conducting liquid, the cooling end of the cooling semiconductor (3) and the heat exchange coil (5) are installed in the heat exchange chamber (6), and the two ends of the heat exchange coil (5) are connected to the atmospheric pressure oxygenation chamber (1) and the high pressure oxygenation chamber (13) respectively.

5. The pressure-controllable hyperoxia myocardial perfusion device according to claim 4, characterized in that, The blood-side mechanical pressurization unit includes a sleeve (26), a lead screw (25), and a servo motor (21); the top of the pressurization plate (27) is fixedly connected to the bottom of the sleeve (26), the sleeve (26) is sleeved on the threaded section of the lead screw (25), and the top of the lead screw (25) is fixedly connected to the output end of the servo motor (21).

6. The pressure-controllable hyperoxia myocardial perfusion device according to claim 4, characterized in that, The oxygen-side pressure control unit includes a pneumatic pump (23) and two gas supply pipes (24); the pneumatic pump (23) can be connected to an external oxygen source, and the outlet of the pneumatic pump (23) is connected to the two gas supply pipes (24) at the same time. The outlets of the two gas supply pipes (24) are connected to the atmospheric pressure oxygen chamber (2) and the high pressure oxygen chamber (12) respectively. Solenoid valves (22) are provided on both gas supply pipes (24).

7. The pressure-controllable hyperoxia myocardial perfusion device according to claim 2, characterized in that, The pressurization mechanism includes a cylinder (37), a pressurization piston (39), two intake pipes (33), an exhaust pipe (15), a three-way valve (40), two pressurization pipes (42), two check valves, and a reciprocating drive unit; the cylinder (37) is fixedly mounted on the device body (4), the pressurization piston (39) is slidably disposed in the cylinder (37), and the power output end of the reciprocating drive unit is connected to the pressurization piston (39) and drives the pressurization piston (39) to reciprocate along the cylinder (37); the cylinder ( The end of 37) is connected to both the intake pipe (33) and the exhaust pipe (15). Two one-way valves are installed in the intake pipe (33) and the exhaust pipe (15) respectively. The exhaust pipe (15) is connected to the two pressurizing pipes (42) through a three-way valve (40). The ends of the two pressurizing pipes (42) away from the three-way valve (40) are connected to the high-pressure oxygen chamber (12) and the high-pressure oxygenation chamber (13) respectively. The cooling semiconductor (3) is embedded in the pressurizing plate (27) for directly cooling the blood.

8. The pressure-controllable hyperoxia myocardial perfusion device according to claim 7, characterized in that, The reciprocating drive unit includes a second motor (41), a rotating disk (35), a connecting rod (34), a slider (38), and a limiting groove (36); the limiting groove (36) is fixedly installed at the end of the cylinder (37), the slider (38) is slidably disposed in the limiting groove (36), and one end of the slider (38) is connected to the pressure piston (39) through the rod body; the two ends of the connecting rod (34) are respectively hinged to the surface of the slider (38) and the rotating disk (35); the output end of the second motor (41) is fixedly connected to the axis of the rotating disk (35).

9. The pressure-controllable hyperoxia myocardial perfusion device according to claim 1, characterized in that, The blocking peristaltic pump includes a housing (8), a motor (28), a hollow shaft (32), a hydraulic drive unit, and multiple sets of rolling telescopic units. The output end of the motor (28) is connected to the hollow shaft (32). Multiple sets of rolling telescopic units are installed on the outer wall of the hollow shaft (32) with equal arc length spacing. The hydraulic drive unit is installed on the hollow shaft (32). A sealed chamber filled with hydraulic oil is formed between the hollow shaft (32), the hydraulic drive unit, and the multiple sets of rolling telescopic units. The hydraulic drive unit controls the extension and retraction length of the multiple sets of rolling telescopic units through hydraulic transmission, thereby realizing the continuous adjustment of the extrusion intensity during the pumping process. It can also completely close the connecting pipe (7) during the non-pumping stage to ensure the sealing and isolation of the high-pressure oxygenation chamber (13).

10. A pressure control method for preparing hyperoxia myocardial perfusion solution, characterized in that, This method is applied to any one of the hyperoxia myocardial perfusion devices according to claims 1-9; the specific method is as follows: S1: After the base fluid is injected into the high-pressure oxygenation chamber, the controller controls the blocking peristaltic pump located at the inlet and outlet of the high-pressure oxygenation chamber to close the corresponding pipeline, so that the high-pressure oxygenation chamber forms a closed chamber. S2: The controller drives the pressurization mechanism to operate, simultaneously pressurizing the liquid and gas sides of the oxygenation membrane cloth in the high-pressure oxygenation chamber, and monitoring the pressure data of the pressure sensors in the high-pressure oxygenation chamber and the high-pressure oxygen chamber in real time. S3: When the pressure data fed back by the pressure sensor reaches the preset target pressure value, the controller controls the pressurization mechanism to switch to the pressure maintenance mode in order to maintain the dynamic pressure balance on both sides of the oxygenation membrane. S4: The controller continuously receives oxygen partial pressure data monitored by the oxygen partial pressure sensor. When the oxygen partial pressure data reaches the preset ultra-high oxygenation threshold, the controller starts pressure relief and controls the pressurization mechanism to gradually reduce the pressure in the high-pressure oxygenation chamber and oxygen chamber according to the set time interval and pressure gradient. S5: After the pressure drops to normal pressure, the controller adjusts the blocking peristaltic pump at the outlet of the high-pressure oxygenation chamber to open the outlet pipeline and deliver the prepared ultra-high oxygenation infusion solution to the infusion pipeline through the pump.

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