Hemorrhagic shock life support system and method of use thereof

Abstract

The present application relates to the technical field of first-aid medical devices, and discloses a hemorrhagic shock life support system and a use method thereof, which comprises a low-flow extracorporeal circulation device, an independent air-controlled double-channel gas exchange membrane assembly, an automatic gas delivery instrument and a red blood cell-free oxygen-carrying blood supplement, and is composed of four parts in cooperation. The present application can maintain the hematocrit of a hemorrhagic shock patient in a safe treatment interval of 10% to 30% without transfusion of allogeneic red blood cells, effectively improves the total oxygen-carrying capacity of mixed blood, removes accumulated carbon dioxide, and quickly corrects the problems of tissue hypoxia, acid-base imbalance and insufficient circulating volume caused by shock. At the same time, the present application completely avoids the hemolysis, allergy, infection, inflammatory reaction and long-term cumulative adverse reactions caused by allogeneic red blood cell transfusion, is compatible with the existing clinical CRRT / HD equipment architecture, is suitable for multiple scene short-time life support treatment requirements, and fills the technical blank of emergency life support for hemorrhagic shock under the condition of no allogeneic blood transfusion.

Description

Technical Field

[0001] This invention relates to the fields of emergency medical devices, extracorporeal life support, and artificial blood replacement technology, specifically to a low-flow extracorporeal circulation gas exchange and volume-combined life support system adapted for hemorrhagic shock and without the need for allogeneic red blood cell transfusion, and its method of use. Background Technology

[0002] Traumatic hemorrhagic shock is the leading cause of death in traffic accidents, engineering accidents, and battlefield trauma. Its core pathophysiological mechanism is an acute sharp decrease in effective circulating blood volume and loss of oxygen-carrying carriers in red blood cells, which in turn leads to systemic tissue hypoperfusion, hypoxia, acid-base imbalance, and multiple organ dysfunction, which can cause death in a short period of time.

[0003] The current standard clinical treatment plan relies on allogeneic red blood cell transfusion to restore the blood's oxygen-carrying capacity, combined with crystalloid / colloid fluid volume expansion. However, this plan has significant limitations in various scenarios: in pre-hospital emergency care, disaster sites, and field medical settings, there are problems such as insufficient blood reserves, time-consuming matching, and delayed transportation. At the same time, allogeneic red blood cell transfusion carries immediate risks such as hemolysis, fever, allergies, pathogen infection, and immune inflammatory reactions. Multiple transfusions can also cause long-term cumulative immune damage.

[0004] Existing extracorporeal life support technologies have significant technical shortcomings: Conventional ECMO is designed for high-flow complete blood oxygenation, but the equipment is bulky, has stringent anticoagulation requirements, and high consumable costs. It cannot adapt to the special pathological state of blood dilution and low hematocrit after blood loss, and is prone to tubing coagulation and blood component damage. CRRT equipment can achieve low-flow extracorporeal circulation and volume regulation, but it lacks active gas exchange and oxygenation enhancement functions. The existing dual-chamber oxygenator patent (CN109364314B) is only designed for conventional surgical extracorporeal circulation and has not optimized the structure and parameters to address the CO2 transport defects and insufficient oxygenation in blood dilution caused by hemorrhagic shock, resulting in poor adaptability to treatment.

[0005] In summary, the industry currently lacks a dedicated emergency life support system for hemorrhagic shock that can be adapted to low hematocrit blood dilution, operate with low flow rates and minimally invasive techniques, does not require allogeneic blood transfusions, and is compatible with existing clinical equipment. This invention addresses the aforementioned technological gap by achieving technological innovation and solution implementation. Summary of the Invention

[0006] Addressing the shortcomings of existing technologies and industry pain points, this invention aims to provide a life support system for hemorrhagic shock and its usage method. Through the coupling of three technologies—low-flow extracorporeal circulation, differentiated gas exchange through different channels, and artificial oxygenated blood replenishment—it can rapidly restore the circulatory volume, oxygen delivery capacity, and blood gas balance of patients with hemorrhagic shock without relying on allogeneic red blood cell transfusions. This enables emergency life support in multiple scenarios, buying valuable time for patient transfer, surgical hemostasis, and blood supply allocation.

[0007] The core of this invention comprises four synergistic components: a low-flow extracorporeal circulation device, an independently controlled dual-channel gas exchange membrane assembly, an automatic gas delivery system, and a blood cell-free oxygenated blood supplement. The circulation device is a CRRT / HD-grade low-flow extracorporeal circulation device, avoiding the anticoagulation risks and equipment redundancy issues of high-flow oxygenation devices. The dual-channel gas exchange membrane assembly is sequentially configured with CO2 removal and O2 dissolution channels along the blood flow direction. The gas path parameters of the two channels are independently adjustable, and the gas exchange efficiency is differentiated based on the physiological characteristics of CO2 transport in diluted blood, prioritizing the correction of hypercapnia after hemorrhagic shock before precisely achieving blood oxygenation. The blood-carrying supplement is an isotonic solution without intact red blood cells, which, through the combination of HBOC / FBOC dual oxygen carriers with colloids, electrolytes, and hematopoietic auxiliary components, simultaneously achieves blood volume expansion, enhances plasma oxygen-carrying capacity, and maintains homeostasis.

[0008] This invention can maintain the hematocrit of hemorrhagic shock patients within a safe treatment range of 10%–30% without the transfusion of allogeneic red blood cells. It effectively increases the total oxygen-carrying capacity of the mixed blood, removes accumulated carbon dioxide, and rapidly corrects tissue hypoxia, acid-base imbalance, and insufficient circulatory volume caused by shock. Simultaneously, it completely avoids the hemolysis, allergic reactions, infections, inflammatory reactions, and long-term cumulative adverse reactions caused by allogeneic red blood cell transfusion. The device is compatible with existing clinical CRRT / HD equipment architecture and adapts to the short-term life support needs in various scenarios, including pre-hospital, in-hospital, and battlefield settings, filling the technological gap in emergency life support for hemorrhagic shock in the absence of allogeneic blood transfusions.

[0009] This invention is achieved through the following technical solution: This invention provides a life support system for hemorrhagic shock, comprising: Circulation equipment is an extracorporeal circulation device used to draw blood from a patient's vein, process it, and then return it to the patient's vein or artery. It includes a peristaltic pump and its connected tubing and monitoring and control module. A dual-channel gas exchange membrane module is used for precise control of gas exchange efficiency and is connected to a matching pipeline. It adopts a parallel U-shaped dual-channel structure, with independent CO2 removal and O2 dissolution channels, both of which have hollow fiber membrane modules. The first gas exchange membrane module has a CO2 removal channel with an air or O2-containing gas inlet and a blood inlet at the top, and a CO2 gas outlet and a blood outlet at the bottom. The blood outlet is connected to the blood inlet of the second gas exchange membrane module via a blood connecting pipe. The air or O2-containing gas inlet is connected to an air or O2-containing gas delivery pipeline, and the blood inlet is connected to a blood circulation pipeline. The second gas exchange membrane module has an O2 dissolution channel with a proportional O2 or pure O2 gas inlet at the top. The blood outlet has an air or O2-containing gas outlet and a blood inlet at its bottom. The blood inlet is connected to the blood outlet of the first gas exchange membrane assembly via a blood connecting tube. The proportional O2 or pure O2 gas inlet is connected to a proportional O2 or pure O2 gas delivery pipeline. The CO2 removal channel has a first gas inlet, a first gas outlet, a blood inlet, and a blood outlet, used to introduce a mixed gas with an oxygen concentration of 21% to 50% to remove and dilute the carbon dioxide accumulated in the blood. The O2 dissolution channel has a second gas inlet, a second gas outlet, a blood inlet, and a blood outlet, used to introduce oxygen-enriched or pure oxygen gas with an oxygen concentration of 90% to 100% to accurately dissolve oxygen into the blood. An automatic gas delivery system, connected to a dual-channel gas exchange membrane module, is used to precisely control the concentration ratio, pressure, flow rate, and temperature of the delivered gas. The oxygen-carrying blood supplement is an isotonic solution containing no intact mammalian red blood cells, used to stably maintain the hematocrit of circulating blood in patients with hemorrhagic shock within a safe treatment range of 10%–30%. The oxygen-carrying blood supplement includes electrolyte components, colloidal volume-expanding components, hematopoietic auxiliary components, and oxygen carrier components. The oxygen carrier component is one or a combination of two of hemoglobin oxygen carriers or fluorocarbon oxygen carriers in a certain proportion. The oxygen-carrying blood supplement is mixed in real time with the patient's own drawn blood through a three-way port on the blood circulation line, upstream of the blood extraction end or the dual-channel gas exchange membrane assembly.

[0010] To achieve precise regulation of O2 concentration, temperature, pressure, and oxygen flow rate, the drive pump includes a first gas delivery pump, a second gas delivery pump, and a peristaltic pump; the supporting pipeline includes an air or O2-containing gas delivery pipeline, a proportional O2 or pure O2 gas delivery pipeline, a blood circulation pipeline, and an oxygen supplement infusion connection pipeline; the first gas delivery pump is installed on the air or O2-containing gas delivery pipeline, the second gas delivery pump is installed on the proportional O2 or pure O2 gas delivery pipeline, the peristaltic pump is installed on the blood circulation pipeline, and the oxygen supplement infusion connection pipeline is connected to the blood circulation pipeline.

[0011] To ensure gas exchange efficiency, preferably, the hollow fiber membrane material of the CO2 removal channel is selected from either polymethylpentene or polypropylene, and the hollow fiber membrane material of the O2 dissolution channel is selected from either siloxane composite material or polyethersulfone modified membrane. The modified membrane is modified by one of the following methods: blending modification, surface coating, or block copolymerization modification.

[0012] To ensure that the hematocrit of the circulating blood in patients with hemorrhagic shock is maintained stably within the safe treatment range of 10% to 30%, preferably, the isotonic solution containing no intact mammalian viable red blood cells has a mature mammalian red blood cell content of less than 1 × 10⁻⁶. 6 The optimal implementation scheme contains no active mature mammalian red blood cells in the solution at a concentration of cells / μL.

[0013] To ensure that the oxygen solubility of the oxygen-carrying blood supplement is not less than 2.0 mL / dL, preferably, the hemoglobin oxygen carrier is any one of glutaraldehyde-polymerized bovine hemoglobin, polyethylene glycol-modified hemoglobin, or cross-linked human hemoglobin, with a working concentration of 1–15 g / dL; the fluorocarbon oxygen carrier is an oil-in-water emulsion containing perfluorooctane, perfluoronaphthene, or perfluorotripropylamine, with the droplet size controlled at 100–300 nm; under physiological conditions of FiO2 = 1.0 and 37°C, the oxygen solubility of the oxygen-carrying blood supplement is not less than 2.0 mL / dL.

[0014] To prevent tissue edema and loss of effective circulating blood volume, and to assist in promoting the production of the patient's own red blood cells, the colloidal expansion component of the oxygen-carrying blood supplement preferably includes one or more combinations of albumin, hydroxyethyl starch, and gelatin peptides, which are used to stabilize and maintain the patient's plasma colloidal osmotic pressure and prevent tissue edema and loss of effective circulating blood volume. The oxygen-carrying blood supplement also contains one or more hematopoietic active ingredients selected from heme iron, vitamin B12, folic acid, and erythropoietin, which can assist in promoting the production of the patient's own red blood cells.

[0015] To ensure low-flow circulation throughout the process and eliminate the risk of arterial hypertension injury, the extracorporeal circulation circuit adopts a vein-to-vein dedicated circuit mode. The blood draw end is connected to the patient's femoral vein or internal jugular vein through a 12Fr-14Fr double-lumen central venous catheter, and the blood return end is connected to the patient's right atrium or internal jugular vein.

[0016] To prevent blood clotting in the tubing and to eliminate tubing clotting and systemic clotting disorders, the hemorrhagic shock life support system also includes an anticoagulation module, employing a local citrate anticoagulation scheme, and adding an appropriate concentration of calcium ion chelating agent to the oxygenated blood supplement.

[0017] The present invention also provides a method of using the above-mentioned life support system for hemorrhagic shock, comprising the following steps: First, determine the basic treatment parameters based on the patient's blood loss and physical condition, and then connect all instruments and tubing. The skin surfaces of the patient's blood inlet and outlet are disinfected, and puncture is performed to allow blood to enter the circulation loop; The peristaltic pump delivers blood into the blood channel of the dual-channel gas exchange membrane module. At the same time, the automatic gas delivery device is activated to input air or air with added O2 and proportional O2 or pure oxygen into the dual-channel gas exchange membrane module. The blood removes CO2 and dissolves O2 within the blood channels of the dual-channel gas exchange membrane assembly; Oxygenated blood flows out of the dual-channel gas exchange membrane assembly and enters the body through the return end to complete blood circulation.

[0018] The life support system for hemorrhagic shock of the present invention is composed of a circulation device, a dual-channel gas exchange membrane module, an automatic gas delivery system, an oxygenated blood supplement, an anticoagulation module, etc. The whole system adopts a VV low-flow extracorporeal circulation mode and is compatible with the existing CRRT / HD equipment architecture.

[0019] The circulation equipment establishes a low-flow extracorporeal circulation loop of 0.2–1.0 L / min, completing blood intake and return via a central venous catheter. An intelligent monitoring module monitors blood flow, blood gas parameters, tubing pressure, and coagulation status in real time to ensure stable circulation. Additionally, it includes an automatic gas delivery system that automatically adjusts O2 concentration, temperature, and pressure, as well as the concentration, temperature, and pressure of purified air, along with corresponding piping.

[0020] The dual-channel gas exchange membrane module features an innovative parallel U-shaped dual-channel, dual independent gas path, and U-shaped through-type blood path integrated structure, completely different from the traditional front-to-back series oxygenation structure: the CO2 removal channel and the O2 dissolution channel are completely isolated and do not cross-contaminate, and the ventilation flow rate, oxygen concentration and ventilation pressure can be independently adjusted according to blood gas indicators to precisely match the differentiated functional requirements of CO2 removal and O2 dissolution; the U-shaped through-type blood path design effectively shortens the blood flow path and reduces redundant bends in the tubing, which effectively reduces the blood chamber volume and blood shear force compared with the traditional series structure, significantly reducing the risk of blood cell damage and hemolysis.

[0021] This invention addresses the differences in clinical populations by setting up various standardized membrane component specifications for adolescents and adults, matching the circulatory and metabolic characteristics of patients with different weights to achieve precise treatment based on age and type. Based on the unique pathological defects of diluted blood, this invention differentiates and limits the efficiency of dual-channel gas exchange: artificially constraining CO2 removal efficiency to be 10%–30% higher than O2 transfer efficiency. This not only fully compensates for the damaged carbamate hemoglobin CO2 transport pathway in low-Hct blood and corrects hypercapnia in shock, but also avoids respiratory alkalosis caused by excessive CO2 elution, achieving precise bidirectional balance of blood gas parameters.

[0022] The oxygenated blood supplement is a red blood cell-free isotonic solution that uses HBOC / FBOC oxygen carriers to replace the oxygen-carrying function of autologous red blood cells. Combined with electrolytes, colloids, and hematopoietic auxiliary components, it precisely replenishes blood loss, maintains colloid osmotic pressure, and increases the total oxygen-carrying capacity of diluted blood, keeping the patient's Hct stable within the safe treatment range of 10% to 30%.

[0023] The anticoagulation module uses local citrate anticoagulation, matched with a supplemental chelation system. The low-intensity anticoagulation is suitable for low-flow circulation, significantly reducing the risk of bleeding and coagulation complications.

[0024] In summary, this invention has the following substantial innovations and significant technological advancements: (1) Completely get rid of dependence on allogeneic red blood cells: Through artificial oxygen carrier composite membrane oxygenation technology, emergency life support can be achieved under conditions of no allogeneic blood transfusion, which is perfectly adapted to special scenarios of blood shortage such as battlefield, pre-hospital, and disaster. (2) Adapted to the physiological characteristics of diluted blood: The first U-shaped dual-channel differentiated gas exchange design specifically compensates for the defects of low Hct blood CO2 transport pathway, accurately corrects shock hypercapnia and tissue hypoxia, and the blood gas regulation accuracy is far superior to conventional single-chamber oxygenation equipment. (3) Strong clinical adaptability and low trauma: The CRRT-level low-flow circulation mode is compatible with existing mainstream clinical equipment, does not require special large equipment, has low anticoagulation intensity, less damage to blood components, and significantly reduces the risk of postoperative complications; (4) Individualized treatment and high safety: The supplement infusion volume, gas parameters and circulation flow can be dynamically adjusted according to the patient's blood loss, Hct and blood gas indicators. The safe running time can reach 24 hours, the vital signs are maintained stably, and there are no adverse reactions related to allogeneic blood transfusion. Attached Figure Description

[0025] Figure 1 This is a system block diagram of the life support system for hemorrhagic shock of the present invention; Figure 2 This is a schematic diagram of the life support system for hemorrhagic shock of the present invention; Figure 3 This is a schematic diagram of the structure of the dual-channel gas exchange membrane module of the present invention; Figure 4 This is a flowchart illustrating the method of using the hemorrhagic shock life support system of the present invention. Detailed Implementation

[0026] The preferred embodiments of the present invention will now be described in detail with reference to the accompanying drawings, so that the advantages and features of the present invention can be more easily understood by those skilled in the art, thereby providing a clearer and more explicit definition of the scope of protection of the present invention.

[0027] like Figure 1 The illustrated life support system for hemorrhagic shock includes a circulatory device, a dual-channel gas exchange membrane assembly, an oxygenated blood supplement, an automated gas delivery system, and an anticoagulation module. The circulatory device is used to establish an extracorporeal circulation loop that draws blood from the patient's vein and returns the processed blood to the patient's vein or artery. The dual-channel gas exchange membrane assembly is used for gas exchange. The automated gas delivery system is used to precisely control the concentration ratio, pressure, flow rate, and temperature of the delivered gas. The oxygenated blood supplement is used to stably maintain the hematocrit of the circulating blood of the hemorrhagic shock patient within the safe treatment range of 10% to 30%. The anticoagulation module is used to reduce the risk of bleeding and coagulation complications during treatment.

[0028] Specifically, in combination Figure 2 As shown, the circulation device includes a drive pump and connected piping and a monitoring and control module. The circulation device is used to establish an extracorporeal circulation loop that draws blood from the patient's vein and returns the processed blood to the patient's vein or artery. The blood flow rate of the extracorporeal circulation loop is 0.2–1.0 L / min, adapted to the low-flow operation mode of continuous renal replacement therapy (CRRT), and compatible with existing CRRT / HD equipment piping interfaces and control programs. The monitoring and control module is used to monitor blood flow and pressure, and can also be equipped with a pulse oximeter independently. Additionally, it includes an automatic gas delivery system that can automatically adjust O2 concentration, temperature, and pressure, as well as automatically adjust the concentration, temperature, and pressure of purified air mixtures, and corresponding piping.

[0029] The driving pump includes a first gas delivery pump 7, a second gas delivery pump 9, and a peristaltic pump 10. The supporting pipeline includes an air or O2-containing gas delivery pipeline 6, a proportional O2 or pure O2 gas delivery pipeline 5, a blood circulation pipeline 8, and an oxygen supplement infusion connection pipe 14. The first gas delivery pump 7 is installed on the air or O2-containing gas delivery pipeline 6, the second gas delivery pump 9 is installed on the proportional O2 or pure O2 gas delivery pipeline 5, the peristaltic pump 10 is installed on the blood circulation pipeline 8, and the oxygen supplement infusion connection pipe 14 is connected to the blood circulation pipeline 8 through an oxygen supplement infusion tee interface 1401. Specifically, in combination Figure 2 , Figure 3 As shown, the dual-channel gas exchange membrane assembly includes a first gas exchange membrane assembly and a second gas exchange membrane assembly, which are connected by a blood connecting tube 3 and a connecting column 4. The first gas exchange membrane assembly has a CO2 removal channel 1, with an air or O2-containing gas inlet 101 and a blood inlet 103 at the top, and a CO2 gas outlet 102 and a blood outlet 301 at the bottom; the air or O2-containing gas inlet 101 is connected to an air or O2-containing gas delivery pipeline 6; the blood inlet 103 is connected to a blood circulation pipeline 8 (connected to a 12Fr-14Fr double-lumen central venous catheter at the patient's femoral vein or internal jugular vein); the CO2 gas outlet 102 is connected to the air or O2-containing gas delivery pipeline... The second gas exchange membrane assembly has an O2 dissolution channel 2, a proportional O2 or pure O2 gas inlet 201 at the top, and an air or O2-containing gas outlet 202 and a blood inlet 302 at the bottom. The proportional O2 or pure O2 gas inlet 201 is connected to the proportional O2 or pure O2 gas delivery pipeline 5. The air or O2-containing gas outlet 202 is connected to the proportional O2 or pure O2 gas delivery pipeline 13. The blood inlet 302 is connected to the blood connection pipe 3. In addition, a blood outlet 204 is provided on one side of the top of the second gas exchange membrane assembly, and the blood outlet 204 is connected to the blood circulation pipeline 11 (connected to the patient's right atrium or internal jugular vein). The CO2 removal channel 1 includes a CO2 gas removal membrane assembly 104, whose top and bottom ends are sealed with CO2 removal membrane encapsulating adhesive 105. The sides of the CO2 removal membrane encapsulating adhesive 105 are bonded and sealed to the inner wall of the CO2 removal channel 1. O-ring seals 107 are provided between the top edge of the CO2 removal membrane encapsulating adhesive 105 and the inner wall edges of the top and bottom end caps. The O2 dissolution channel 2 includes an O2 dissolution membrane assembly 205, whose top and bottom ends are sealed with O2 dissolution membrane encapsulating adhesive 206. The O2 dissolving film encapsulating adhesive 206 is bonded and sealed to the inner wall of the O2 dissolving channel 2 shell; an O-ring 207 is provided between the top edge of the O2 dissolving film encapsulating adhesive 206 and the inner edge of the top and bottom end caps; in addition, the bottom ends of the CO2 removal channel 1 and the O2 dissolving channel 2 share a common passage connecting cover 106, which has an independent CO2 gas outlet 102, an air or O2-containing gas outlet 202, and a blood connecting tube 3 connecting the blood outlet 301 of the CO2 removal channel 1 and the blood inlet 302 of the O2 dissolving channel 2.

[0030] Combination Figure 4 As shown, the method of using the above-mentioned life support system for hemorrhagic shock is as follows: First, confirm the extent of the patient's blood loss and overall condition, including the functioning of all organs, and determine the patient's life support treatment plan and basic treatment parameters: Establish the basic ratio of oxygen-carrying blood supplement components and infusion dosage to effectively increase the total oxygen-carrying capacity of mixed blood, remove accumulated carbon dioxide, and quickly correct tissue hypoxia, acid-base imbalance and insufficient circulating volume caused by shock. Establish basic operating parameters for the extracorporeal circulation device (CRRT / HD), such as blood flow rate, blood velocity, and the pressure at the blood inlet and outlet of the U-shaped dual-channel gas exchange membrane assembly, in order to maintain stable treatment and keep the hematocrit of hemorrhagic shock patients within the safe treatment range of 10% to 30%. The membrane area of ​​the U-shaped dual-channel gas exchange membrane module is selected according to the patient's weight and physical condition to meet the patient's treatment needs; Establish basic operating parameters for the automatic gas delivery system, such as the ratio of air or O2 added to the gas delivered through the two channels, and set the gas pressure and temperature parameters for the gas delivered through the two channels respectively. Based on the patient's vascular condition, determine the blood access protocol, selecting the diameter of the double-lumen central venous catheter and the puncture site for the blood return end, such as the femoral vein or internal jugular vein. Choose the site for the blood return end, such as the right atrium or internal jugular vein.

[0031] According to the life support treatment protocol: a double-lumen central venous catheter is connected to the blood inlet of the CRRT circulatory line, which is then clamped onto the CRRT peristaltic pump. The blood outlet of the circulatory line is connected to the blood inlet of the U-shaped dual-channel gas exchange membrane assembly. The blood outlet of the U-shaped dual-channel gas exchange membrane assembly is connected to the blood inlet of the circulatory line's output section, and the blood outlet of the circulatory line's output section is connected to the blood return needle. The automatic gas delivery device has an air or O2-added air channel and a proportional O2 or pure oxygen channel connected to a CO2 removal channel and an O2 dissolution channel, respectively. It is also connected to a medical oxygen cylinder and a purified air cylinder.

[0032] The U-shaped dual-channel gas exchange membrane module and circulation tubing were flushed and pre-filled with physiological saline, and the machine was turned on for 15 minutes of circulation, waiting for the treatment to begin. Prepare the oxygenated blood supplement according to the treatment plan and connect it to the oxygenated blood supplement infusion tee on the inlet section of the circulation line. After blood circulation begins, infuse the oxygenated blood supplement to mix with the blood (if the patient has severe blood loss, a certain volume of oxygenated blood supplement should be infused before the start of treatment to maintain the patient's total blood volume so that blood circulation can proceed normally). A pulse oximetry probe is connected to the patient's finger to monitor changes in blood oxygen saturation in real time during treatment, and to accurately determine the patient's blood oxygen carrying capacity in conjunction with pre- and post-membrane blood gas detection. The skin surfaces at both the blood inlet and outlet are disinfected, and a puncture is performed. Blood enters the circulation tubing, and the CRRT peristaltic pump delivers the blood into the blood channel of the U-shaped dual-channel gas exchange membrane module. Simultaneously, an automatic gas delivery system is activated to introduce air or air with added O2, or a proportional amount of O2 or pure oxygen, into the U-shaped dual-channel gas exchange membrane module. Within the blood channel of the U-shaped dual-channel gas exchange membrane module, CO2 is removed and O2 is dissolved. The oxygenated blood flows out of the U-shaped dual-channel gas exchange membrane module and re-enters the body through the return end, completing blood circulation. The treatment duration is determined based on the patient's condition and treatment effect.

[0033] Example 1: System Hardware Selection, Structural Parameters, and Standardized Configuration This embodiment provides the optimal industrial-scale deployment configuration for the present invention, where all parameters are quantifiable, mass-producible, and clinically reproducible. 1.1 Configuration of Circulation Equipment Main unit: Uses commercially available Baxter PrisMax CRRT equipment, retaining the original pump body, monitoring module and piping system, without the need to modify the core hardware; Automatic gas delivery system: adopts a dual-channel structure, one channel for purified air + low-proportion 0 2 One path is pure oxygen or a high proportion of 0 2 + Air purification; airway parameters can be adjusted individually, with gas pressure (operating pressure within the exchange channel) < 50 mmHg, and strictly prohibited from exceeding 80 mmHg; air, 0 2 Mixing ratio from 10-100%; gas flow rate, 0-15 L / min for adults, 0-6 L / min for children / newborns; gas-blood ratio set at 1.5:1-3.5:1 (gas flow rate: extracorporeal blood flow rate); gas temperature 37±1°C; Supporting tubing: A 14Fr double-lumen central venous catheter was selected, with the blood-drawing end inserted into the femoral vein and the blood-returning end inserted into the internal jugular vein to establish a standard VV circulation circuit; Operating parameters: standard treatment blood flow rate 0.3~0.5 L / min, tubing pressure monitoring threshold -200~+300mmHg, temperature maintained at physiological constant temperature of 37℃; Anticoagulation preparation: 4% sodium citrate anticoagulation solution, initial infusion rate of 1.3 times circulating blood flow, real-time monitoring of post-filtration calcium ions, maintaining a concentration of 0.25–0.4 mmol / L.

[0034] 1.2 Standardized parameters for dual-channel gas exchange membrane modules Overall Structure: Utilizing a parallel U-shaped dual-channel split-type sealed double cylindrical shell, with a total length of 120-150mm and an inner diameter of 18-25mm, it completely separates the CO2 removal and O2 dissolution gas paths, eliminating gas crosstalk. The blood circuit adopts a U-shaped through-flow design, resulting in a short blood flow path with no redundant bends, reducing blood chamber volume and effectively minimizing shear damage to blood cells. Multiple standardized mass production specifications are available, with typical specifications as follows: 1 (Suitable for teenagers, 30-55kg): The front-end CO2 removal channel membrane is made of hydrophobic PMP hollow fiber membrane, with a total membrane area of ​​0.2 m². 2 The membrane has a pore size of 0.1 μm and an inner diameter of 150-200 μm. The ventilation medium is purified air (FiO2=21%), and the ventilation flow rate is 1.0–1.5 L / min. The O2 dissolution channel membrane is made of siloxane-modified PMP hollow fiber membrane with a total membrane area of ​​0.4 m². 2 The membrane pore size is 0.1 μm, the inner diameter is 150-200 μm, the ventilation medium is medical pure oxygen (FiO2=100%), and the ventilation flow rate is 0.6-0.8 L / min; the measured CO2 removal efficiency of the dual-channel system is 15%-25% higher than that of O2 transfer. 2 (Adult fit, ≥55kg): The front-end CO2 removal channel membrane is made of hydrophobic PMP hollow fiber membrane, with a total membrane area of ​​0.3 m². 2 The membrane has a pore size of 0.1 μm, an inner diameter of 150-200 μm, and uses purified air (FiO2=21%) as the ventilation medium at a flow rate of 2.0 L / min. The downstream O2 dissolution channel membrane is made of siloxane-modified PMP hollow fiber membrane with a total membrane area of ​​0.8 m². 2 The membrane pore size is 0.1 μm, the membrane inner diameter is 150-200 μm, the ventilation medium is medical pure oxygen (FiO2=100%), and the ventilation flow rate is 1.0 L / min. The measured CO2 removal efficiency of the dual-channel system is 18% higher than that of O2 transfer efficiency, falling into the optimal protection range of 10% to 30%.

[0035] 1.3 Optimal Formula (Mass-Volume Concentration) for Oxygen-Carrying Blood Supplements Base solvent: Compound electrolyte injection (Bomaili A), maintaining physiological osmotic pressure of 280-300 mOsm / L; Colloidal components: Human serum albumin 4.0 g / dL, stabilizing plasma colloid osmotic pressure 22–25 mmHg; Oxygen carrier component: HBOC-201 polymerized bovine hemoglobin 6.0 g / dL, without FBOC compounding; Functional excipients: glucose 1.0 g / dL, vitamin C 50 mg / dL (antioxidant, inhibits methemoglobin production), trace amounts of heme iron and folic acid; Core performance: At 37℃ and FiO2=1.0, the oxygen solubility is 2.3 mL / dL, and no intact red blood cells are found, which meets the standards defined in the claims.

[0036] Example 2: Extracorporeal circulation simulation control experiment 2.1 Experimental Model Construction This embodiment uses fresh anticoagulated pig blood, diluted with physiological saline to prepare hypohematocrit shock-simulating blood. Baseline blood parameters were precisely controlled: Hct=20%, Hb=7.2 g / dL, PvCO2=62 mmHg, and blood lactate=3.8 mmol / L, effectively simulating the pathological characteristics of hypoxia, hypercapnia, and microcirculatory metabolic disorders in clinical severe hemorrhagic shock. A closed-loop extracorporeal circulation experimental circuit was constructed, with a uniform circulation flow rate of 0.4 L / min and a constant experimental temperature of 37 ℃ to ensure complete consistency of baseline conditions across all groups. Strict adherence to the single-variable principle ensured comparable experimental data and scientifically reliable conclusions.

[0037] 2.2 Experimental Group Setup This experiment set up three gradient single-variable control groups and one complete experimental group of the present invention. Through stepwise variable elimination and parameter adjustment, the technical necessity of blank volume dilution baseline conditions, automatic gas delivery instrument parameter adaptation performance, and HBOC / FBOC oxygen carrier oxygen carrying gain module were verified respectively. It fully covered the synergistic verification system of the four core modules of the present invention and accurately demonstrated the nonlinear synergistic effect characteristics of the system.

[0038] Control Group 1 (simple saline volume dilution, blank baseline control: no gas exchange, no oxygen supplementation): Only a low-flow extracorporeal circulation device was used to establish the basic circulation loop, with medical saline infused throughout the process. The dual-channel gas exchange membrane module was not activated, the automatic gas delivery system was not started, there was no artificial gas exchange intervention, and no exogenous oxygen supplementation; only simple volume dilution was performed. Experimental results showed that this group had no active oxygenation or carbon dioxide clearance capacity throughout the process. Arterial blood oxygen saturation remained at 65.2%–69.5%, venous blood oxygen partial pressure was only 18–21 mmHg, and the relative oxygen capacity of blood was 52%. After 4 hours of continuous operation, blood carbon dioxide accumulation increased significantly, and blood lactate continued to rise to 5.9 mmol / L. The model showed severe acidosis and severe microcirculatory metabolic disorders. This confirms that simple saline volume expansion can only maintain basic circulatory volume and does not have any oxygenation compensation or gas correction capacity. It cannot prevent the pathological deterioration of severe hemorrhagic shock and represents the lowest-performing blank control baseline in this experiment.

[0039] Control Group 2 (Automatic Gas Delivery System Functional Parameter Adjustment Control: Membrane Module Flow Path + Blank Base Solution): A low-flow extracorporeal circulation device was configured and fully connected to the dual-channel gas exchange membrane module. The dual-channel gas exchange membrane module and the automatic gas delivery system were operated continuously. By setting high and low gradient gas operating parameters, the regulatory effect of the automatic gas delivery system parameter matching degree on the system's oxygenation performance was verified. This group received a blank base solution throughout the infusion, excluding the core functional components of the HBOC / FBOC oxygen carrier. This solution contained only basic solvents and electrolytes and did not possess oxygen storage, sustained oxygen release, or blood oxygen capacity gain functions, thus completely eliminating interference from oxygen carrier variables. The dual-channel gas was uniformly temperature-controlled at 37±1℃ to ensure constant experimental temperature conditions.

[0040] (1) Low-condition parameter settings and experimental results: The CO2 removal channel was supplied with a mixed gas containing 80% air and 20% oxygen, with a gas pressure of 1 mmHg and a gas flow rate of 1 L / min; the oxygen dissolution channel was supplied with 100% pure oxygen, with a gas pressure of 1 mmHg and a gas flow rate of 1 L / min, so that the membrane module was in the lowest effective gas exchange condition. The experiment showed that the gas replacement force was extremely weak under this low-parameter condition, the gas-liquid diffusion contact efficiency of the membrane module was extremely low, and only extremely limited instantaneous shallow physical oxygenation could be generated; the peak arterial blood oxygen saturation in the early stage of the experiment was only 70.5% to 73.0%, with no high-value stable oxygenation capacity; in the middle and late stages of the experiment, blood oxygen rapidly dropped to 68.2% to 70.1%, the partial pressure of venous blood oxygen was maintained at 21 to 24 mmHg, and the relative oxygen capacity of blood was only 58%; the blood oxygen fluctuated significantly throughout the process, the carbon dioxide removal capacity was extremely poor, the shock hypercapnia could not be improved, and the hypoxic state of the model continued to deteriorate.

[0041] (2) High-load parameter settings and experimental results: A mixed gas containing 80% air and 20% oxygen was introduced into the CO2 removal channel, with a supply pressure of 50 mmHg and a gas flow rate of 8 L / min; 100% pure oxygen was introduced into the oxygen dissolution channel, with a supply pressure of 50 mmHg and a gas flow rate of 8 L / min, so that the membrane module was in the highest load gas exchange condition. The experiment showed that after increasing the supply pressure and flow rate parameters of the automatic gas delivery instrument, the physical gas exchange power of the membrane module was significantly enhanced, and the instantaneous oxygenation capacity was significantly improved; the peak arterial blood oxygen saturation in the early stage of the experiment could reach 82.0% to 84.5%, which was significantly improved compared to the lower operating conditions; however, due to the limitation of the oxygen storage and slow release system of the anaerobic carrier, the oxygenation maintenance capacity was seriously insufficient, and the blood oxygen gradually dropped to 76.0% to 78.2% in the middle and late stages of the experiment, the partial pressure of venous blood oxygen increased to 29 to 32 mmHg, and the relative oxygen capacity of blood increased to 76%. The effective oxygen capacity and instantaneous oxygenation level under high operating conditions were significantly improved compared to low operating conditions, but the overall blood oxygenation stability was still poor, the oxygenation decay problem was prominent, and the body's microcirculation hypoxia could not be continuously improved. There was still a persistent mild metabolic imbalance throughout the experiment, and lactic acid accumulation was irreversible.

[0042] The conclusions of this experiment are as follows: Comparison of gradient parameters confirms that the pressure and flow rate parameters of the automated gas delivery system directly regulate the gas exchange dynamics of the membrane module, significantly affecting the instantaneous blood oxygenation level and effective oxygen capacity, making it the core regulatory unit for the system's oxygenation performance. Under the premise of a complete extracorporeal circulation loop and membrane module hardware structure, the matching degree of the automated gas delivery system's gas supply parameters directly determines the system's gas exchange efficiency and oxygenation upper limit. Under low-parameter conditions, the system exhibits significant defects such as insufficient gas drive, weak carbon removal capacity, and low oxygenation efficiency. Even with complete hardware modules, poor parameter adaptation will still significantly limit overall performance. Furthermore, regardless of whether the gas parameters are low or high, without the synergistic benefit of HBOC / FBOC oxygen carriers for oxygen storage and slow-release oxygen supply, the system faces an inherent technical bottleneck that cannot be overcome: simply relying on mechanical enhancement of physical gas exchange can only increase the instantaneous oxygenation upper limit, failing to address the defects of rapid oxygenation decay, insufficient long-term oxygen supply, and poor blood oxygen stability. It cannot continuously correct persistent tissue hypoxia caused by shock, making it difficult to meet the clinical needs for long-term, stable, and safe extracorporeal life support.

[0043] Control Group 3 (lacking HBOC / FBOC oxygen carrier oxygen-carrying module: optimal gas parameters + blank basic solution): A low-flow extracorporeal circulation device was configured, with the dual-channel gas exchange membrane module and automatic gas delivery system operating continuously. Standardized optimal gas operating parameters were set: the CO2 removal channel was supplied with a mixture of 80% air and 20% oxygen at a pressure of 40 mmHg and a flow rate of 6 L / min; the oxygen dissolution channel was supplied with 100% pure oxygen at a pressure of 50 mmHg and a flow rate of 8 L / min. The gas in both channels was uniformly temperature-controlled at 37±1 ℃ to ensure the membrane module operated under optimal and stable gas exchange conditions. This group received a blank basic solution devoid of the core functional components of the HBOC / FBOC oxygen carrier. This solution contained only the basic solvent and electrolyte, and had no oxygen storage or slow-release oxygen function. Experimental results showed that the active gas exchange system with optimal parameters could only achieve transient, shallow physical oxygenation. In the initial stage, the peak arterial oxygen saturation was only 82.3%–84.7%, gradually decreasing to 76.2%–78.5% in the later stages. Venous oxygen partial pressure ranged from 29 to 32 mmHg with significant fluctuations, and the relative oxygen capacity was only 76%. Overall oxygen stability was poor, failing to continuously improve the body's hypoxic state and exhibiting persistent mild metabolic imbalance. This confirms that even under optimal operating conditions with all functions of the circulatory loop, gas delivery, and membrane module gas exchange complete, the system still suffers from technical bottlenecks such as insufficient oxygen capacity, lack of long-term oxygen supply, and poor oxygen supply stability when the synergistic benefits of oxygen carrier storage and slow-release oxygen supply are absent. It cannot continuously correct tissue hypoxia caused by shock and fails to meet the clinical needs of long-term life support.

[0044] Experimental group (complete four-module synergistic scheme of the present invention): adopts low-flow extracorporeal circulation equipment and dual-channel gas exchange membrane module, with automatic gas delivery device running throughout the process and matched with the optimal standardized gas parameters of control group 3, infusing the oxygen-carrying blood supplement of the present invention containing HBOC / FBOC oxygen carrier. The equipment operating parameters and circuit configuration strictly match the standard configuration of Example 1, so that the four core modules of low-flow extracorporeal circulation circuit, automatic gas delivery device, dual-channel gas exchange membrane module, and HBOC / FBOC oxygen carrier are coupled and coordinated throughout the process.

[0045] 2.3 Dynamic monitoring indicators and quantitative experimental results The experiment dynamically monitored key indicators such as oxidative stability, carbon dioxide clearance efficiency, blood oxygenation performance, and microcirculatory metabolic improvement at different time points and key sites in the circuit. The quantitative comparison results of the four experimental groups are shown in the table below: 2.4 Module Coupling, Synergistic Effect, and Creativity Analysis Based on the above quantitative experimental results, it is clear that the four core modules of this invention have clearly defined functions, support each other, and are irreplaceable, with no functional redundancy. The absence of any module or incomplete functional adaptation will lead to a precipitous deterioration in the overall system performance. Among them, the low-flow extracorporeal circulation device provides a stable and low-damage closed-loop circulation power foundation; the automatic gas delivery device provides precise and controllable active driving power for gas exchange in the membrane module, which is the core prerequisite for achieving efficient and controllable gas-liquid replacement; the dual-channel gas exchange membrane module provides an efficient gas-liquid contact exchange carrier, completing the precise removal of carbon dioxide and efficient diffusion and replenishment of oxygen; the HBOC / FBOC oxygen carrier oxygen supplement plays a key role in oxygen storage, slow-release oxygen supply, and microcirculation metabolic repair, making up for the inherent defects of the transient and unstable nature of traditional membrane oxygenation.

[0046] The three control groups form a complete, rigorous, and progressively progressive single-variable gradient verification system with a clear logical loop: Control group 1 is a pure capacity expansion blank baseline without any gas correction or oxygenation function, and the degree of shock pathological deterioration is the most significant, proving that without gas exchange and oxygen-carrying intervention, the deterioration of shock cannot be stopped; Control group 2, through high and low parameter gradient comparison, verifies that the parameter adaptability of the automatic gas delivery device directly determines the system's oxygenation efficiency. Insufficient parameters result in extremely low oxygenation efficiency. Parameter optimization can improve instantaneous oxygenation, but it cannot solve the problem of long-term stable oxygen supply, proving that the gas-driven module is the foundation of oxygenation, but its independent function has inherent shortcomings; Control group 3 conducts experiments under optimal gas parameters and complete hardware conditions, completely eliminating equipment parameters and hardware interference, and specifically verifying the necessity of the oxygen carrier module, confirming that relying solely on physical membrane oxygenation, without the oxygen carrier's oxygen storage and slow-release gain, always suffers from insufficient oxygen capacity, rapid oxygenation decay, and irreversible metabolic imbalance.

[0047] Only the experimental group of this invention achieved complete coupling and synergistic operation of the four modules, simultaneously realizing efficient carbon removal, ultra-high instantaneous oxygenation, high-capacity oxygen storage, long-term stable sustained-release oxygen supply, and correction of microcirculatory metabolic disorders. The overall technical effect far exceeds the simple superposition of the independent functions of each module, effectively verifying the nonlinear synergistic effect of 1+1+1+1>4. Through modular and precise coupling design, this invention specifically addresses the industry pain points of traditional in vitro life support technologies, such as low oxygenation efficiency, unstable oxygen supply, inability to long-term reverse shock metabolic damage, and poor oxidative safety. It possesses outstanding substantial technical progress and significant clinical applicability, fully meeting the inventiveness and practicality requirements for invention patent authorization.

[0048] 2.5-point scale comparison experimental design and overall experimental conclusions To verify the suitability of the dual-size classification design of this invention for different populations, this experiment set up an adult size experimental group and an adolescent size experimental group. A uniform severe hemorrhagic shock blood dilution model (Hct=20%, constant temperature 37℃) was used, and the circulation flow, membrane area and ventilation parameters were matched to the corresponding weight ranges to carry out control verification. The control group was kept unchanged.

[0049] 2.5.1 Adult-sized experimental group (≥55kg suitable): Circulating blood flow 0.4 L / min, using adult-specific membrane module parameters: CO2 removal channel membrane area 0.3 m² 2 Air flow rate: 2.0 L / min; O2 dissolution channel membrane area: 0.8 m² 2 The pure oxygen ventilation flow rate was 1.0 L / min, with a theoretical efficiency difference of 18% between the two channels. Core experimental results: MetHb was <12% throughout the experiment, with a final value of 11.5% at 6 hours; pre-membrane PvCO2 was 60–63 mmHg, and post-membrane PCO2 was stable at 38–42 mmHg, indicating complete correction of hypercapnia without excessive clearance; post-membrane PO2 reached 412–435 mmHg, and CaO2 was stable at 11.2–11.8 mL / dL; blood lactate decreased from 3.8 mmol / L to 1.8 mmol / L at 6 hours, indicating complete improvement of tissue hypoxia and stable blood gas balance.

[0050] 2.5.2 Adolescent-sized experimental group (suitable for 30–55 kg): Considering the physiological characteristics of adolescents—small blood volume, metabolic sensitivity, and narrow blood gas regulation window—the circulating blood flow rate was adjusted down to 0.25 L / min, and the parameters of the adolescent-specific membrane module were adopted: CO2 removal channel membrane area 0.2 m². 2 Ventilation flow rate: 1.2 L / min; O2 dissolution area in the channel membrane: 0.4 m² 2The ventilation flow rate was 0.7 L / min, with a theoretical efficiency difference of 20% between the two channels. Key experimental results: Superior oxygen carrier stability; MetHb remained <10% throughout the process, with a final value of only 9.2% at 6 hours; baseline pre-membrane hypercapnia was 60–63 mmHg, while post-membrane PCO2 was precisely maintained at 36–40 mmHg, with a gentle correction and no risk of alkalosis; post-membrane PO2 was maintained at 380–410 mmHg, and CaO2 remained stable at 10.8–11.5 mL / dL, fully meeting the basic oxygen supply needs of adolescents; blood lactate decreased from 3.7 mmol / L to 1.6 mmol / L at 6 hours, demonstrating good improvement in microcirculation perfusion. The measured efficiency ratio of the dual channels for adolescents was 1.20, consistent with the adult specification of 1.18, both consistently falling within the patented efficiency range of 10%–30%.

[0051] 2.5.3 Overall Experimental Conclusions: Dual-specification controlled experiments in adults and adolescents fully validated that the modular membrane module of this invention, based on a parallel U-shaped independent dual-gas path and a U-shaped through-flow low-damage blood pathway structure, can precisely match the circulatory load, blood gas metabolism, and physiological tolerance characteristics of individuals with different weights. Through differentiated membrane area, individualized ventilation parameters, and a fixed 10%–30% efficiency difference constraint system, carbon dioxide removal and oxygen dissolution can be safely and accurately achieved in hemorrhagic shock with low hematocrit and diluted blood. The dual-specification system exhibited excellent oxygen carrier stability, with no complications such as hemolysis, methemoglobin accumulation, acid-base imbalance, or hypooxygenation throughout the process. This demonstrates that the age- and type-specific design of this invention possesses strong scientific validity, clinical adaptability, and safety, and exhibits significant technological innovation and clinical advantages compared to traditional single-specification oxygenation devices.

[0052] Example 3: Validation of the effectiveness of the live animal model 3.1 Experimental Animals and Model Establishment Twelve healthy adult Bama miniature pigs, weighing 28–32 kg, half male and half female, were randomly divided into a control group and an experimental group, with six pigs in each group. Routine anesthesia, endotracheal intubation, and mechanical ventilation were performed. The femoral artery and internal jugular vein were isolated, and mean arterial pressure (MAP), heart rate (HR), and central venous pressure (CVP) were continuously monitored. MAP was lowered to 40–50 mmHg through uniform bloodletting from the femoral artery, and the shock state was maintained for 30 minutes to establish a stable model of severe hemorrhagic shock.

[0053] 3.2 Group Treatment Plan Control group: Standard clinical treatment regimen, including crystalloid fluid resuscitation and allogeneic porcine red blood cell transfusion; Experimental group: Allogeneic blood transfusion was discontinued, and the oxygenated blood supplement of this invention was infused (the total infusion volume was 1.5 times the blood loss). The life support system of this invention was started simultaneously, with a circulation flow rate of 0.4 L / min and standardized anticoagulation throughout the process.

[0054] 3.3 Core Observation Indicators and Results Hemodynamic parameters: Within 30 minutes of treatment, the MAP in the experimental group rose from 42 mmHg to 81-85 mmHg, CVP was maintained at 6-8 cmH2O, and heart rate decreased from 135 beats / min to 95-105 beats / min. There was no significant difference in hemodynamic stabilization effect between the experimental group and the control group (P>0.05). Oxygen metabolism indicators: 1 hour after treatment, the central venous oxygen saturation (ScvO2) in the experimental group increased from 32% to over 68%, the lactate clearance rate reached 42%, and the lactate level basically returned to normal after 24 hours. Long-term prognostic indicators: The 72-hour survival rate of both groups of animals was 100%, there were no significant differences in liver and kidney function biochemical indicators, and the pathological sections of kidney and myocardial tissues showed no obvious hypoxic damage, edema and inflammatory infiltration. Safety indicators: No tubing clotting, bleeding complications, or methemoglobin accumulation occurred in the experimental group throughout the entire process, and no allergic or hemolytic reactions related to allogeneic blood transfusion were observed.

[0055] 3.4 Experimental Conclusions The system of this invention can rapidly stabilize the hemodynamics of animals in hemorrhagic shock, correct tissue hypoxia, and protect organ function without the need for allogeneic red blood cell transfusion. The treatment effect is not inferior to the routine clinical allogeneic blood transfusion protocol, and it is safer and has a wider range of applications.

[0056] Based on the above-described preferred embodiments of the present invention, and through the foregoing description, those skilled in the art can make various changes and modifications without departing from the inventive concept. The technical scope of this invention is not limited to the contents of the specification, but must be determined according to the scope of the claims.

Claims

1. A life support system for hemorrhagic shock, characterized in that: include A circulation device used to draw blood from a patient's vein, process it, and then return it to the patient's vein or artery, including a drive pump and associated tubing and a monitoring and control module. A dual-channel gas exchange membrane module, connected to a circulation device, is used to precisely control gas exchange efficiency. Connected to supporting pipelines, it adopts a parallel U-shaped dual-channel structure, featuring independent CO2 removal and O2 dissolution channels. Both the CO2 removal and O2 dissolution channels have hollow fiber membrane modules. The CO2 removal channel has a first gas inlet, a first gas outlet, and a blood inlet, used to introduce a mixed gas with an oxygen concentration of 21%–50% to remove and dilute accumulated carbon dioxide in the blood. The O2 dissolution channel has a second gas inlet, a second gas outlet, and a blood outlet, used to introduce oxygen-enriched or pure oxygen gas with an oxygen concentration of 90%–100% to precisely dissolve oxygen into the blood. An automatic gas delivery system, connected to a dual-channel gas exchange membrane module, is used to precisely control the concentration ratio, pressure, flow rate, and temperature of the delivered gas. The oxygenated blood supplement is an isotonic solution containing no intact mammalian red blood cells, used to stably maintain the hematocrit of circulating blood in patients with hemorrhagic shock within a safe treatment range of 10% to 30%. The oxygenated blood supplement includes electrolyte components, colloidal volume-expanding components, hematopoietic auxiliary components, and oxygen carrier components. The oxygen carrier component is one or a combination of two of hemoglobin oxygen carriers or fluorocarbon oxygen carriers in any proportion. The oxygenated blood supplement is mixed in real time with the patient's own drawn blood through a three-way interface in the circulation loop at the blood extraction end or upstream of the dual-channel gas exchange membrane assembly.

2. The life support system for hemorrhagic shock according to claim 1, characterized in that: The driving pump includes a first gas delivery pump, a second gas delivery pump, and a peristaltic pump. The supporting pipeline includes an air or O2-containing gas delivery pipeline, a proportional O2 or pure O2 gas delivery pipeline, a blood circulation pipeline, and an oxygen-carrying supplement infusion connection pipeline. The first gas delivery pump is located on the air or O2-containing gas delivery pipeline, the second gas delivery pump is located on the proportional O2 or pure O2 gas delivery pipeline, the peristaltic pump is located on the blood circulation pipeline, and the oxygen-carrying blood supplement infusion connection pipeline is connected to the blood circulation pipeline through a T-junction.

3. The life support system for hemorrhagic shock according to claim 2, characterized in that: The dual-channel gas exchange membrane assembly includes a first gas exchange membrane assembly and a second gas exchange membrane assembly. The first gas exchange membrane assembly has a CO2 removal channel, an air or O2-containing gas inlet and a blood inlet at the top, and a CO2 gas outlet and a blood outlet at the bottom. The air or O2-containing gas inlet is connected to an air or O2-containing gas delivery pipeline. The blood inlet is connected to a blood circulation pipeline, and the blood outlet is connected to the blood inlet of the second gas exchange membrane assembly via a blood connecting pipe. The second gas exchange membrane assembly has an O2 dissolution channel, a proportional O2 or pure O2 gas inlet and a blood outlet at the top, and an air or O2-containing gas outlet and a blood inlet at the bottom. The proportional O2 or pure O2 gas inlet is connected to a proportional O2 or pure O2 gas delivery pipeline, and the blood outlet is connected to a blood circulation pipeline.

4. The life support system for hemorrhagic shock according to claim 1 or 3, characterized in that: The hollow fiber membrane material of the CO2 removal channel is selected from either polymethylpentene or polypropylene, and the hollow fiber membrane material of the O2 dissolution channel is selected from either siloxane composite material or polyethersulfone modified membrane. The modified membrane is modified by one of the following methods: blending modification, surface coating or block copolymerization modification.

5. The life support system for hemorrhagic shock according to claim 1, characterized in that: The isotonic solution containing no intact, viable mammalian erythrocytes has a mature mammalian erythrocyte content of less than 1 × 10⁻⁶. 6 per μL.

6. The life support system for hemorrhagic shock according to claim 1, characterized in that: The hemoglobin oxygen carrier is any one of glutaraldehyde-polymerized bovine hemoglobin, polyethylene glycol-modified hemoglobin, or cross-linked human hemoglobin, with a working concentration of 1–15 g / dL; the fluorocarbon oxygen carrier is an oil-in-water emulsion containing perfluorooctane, perfluoronaphthene, or perfluorotripropylamine, with droplet size controlled at 100–300 nm; under physiological conditions of FiO2 = 1.0 and 37°C, the oxygen solubility of the oxygen-carrying blood supplement is not less than 2.0 mL / dL.

7. The life support system for hemorrhagic shock according to claim 1, characterized in that: The colloidal expansion component of the oxygen-carrying blood supplement includes one or more combinations of albumin, hydroxyethyl starch, and gelatin peptides, which are used to stabilize and maintain the patient's plasma colloidal osmotic pressure and prevent tissue edema and loss of effective circulating blood volume. The oxygen-carrying blood supplement also contains one or more hematopoietic active ingredients, including heme iron, vitamin B12, folic acid, and erythropoietin, which can help promote the production of the patient's own red blood cells.

8. The life support system for hemorrhagic shock according to claim 1, characterized in that: The extracorporeal circulation circuit adopts a vein-to-vein dedicated circuit mode. The blood draw end is connected to the patient's femoral vein or internal jugular vein through a 12Fr-14Fr double-lumen central venous catheter, and the blood return end is connected to the patient's right atrium or internal jugular vein.

9. The life support system for hemorrhagic shock according to claim 1, characterized in that: The life support system for hemorrhagic shock also includes an anticoagulation module, which employs a local citrate anticoagulation regimen, and the oxygenated blood supplement contains an appropriate concentration of calcium ion chelating agent.

10. A method of using the life support system for hemorrhagic shock as described in any one of claims 1-9, characterized in that, Includes the following steps: First, determine the basic treatment parameters based on the patient's blood loss and physical condition, and then connect all instruments and tubing. The skin surfaces of the patient's blood inlet and outlet are disinfected, and puncture is performed to allow blood to enter the circulation loop; The peristaltic pump delivers blood into the blood channel of the dual-channel gas exchange membrane module. At the same time, the automatic gas delivery device is activated to input air or air with added O2 and proportional O2 or pure oxygen into the dual-channel gas exchange membrane module. The blood removes CO2 and dissolves O2 within the blood channels of the dual-channel gas exchange membrane assembly; Oxygenated blood flows out of the dual-channel gas exchange membrane assembly and enters the body through the return end to complete blood circulation.

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