Device and method for inputting medicine into veins of human body

Abstract

The invention relates to the technical field of medical instruments, in particular to a device and method for inputting medicine into veins of a human body. The device for inputting the medicine into the veins of the human body comprises an air source, an air delivery pipe, a flow regulating valve, a flow detection device and an in-body tip, the gas source is connected with the body-entering tip through the gas delivery pipe, gas which can be combined with blood in a physical, chemical and / or biological form is input into veins of a human body, and bubbles which are not wrapped by other substances and are in direct contact with the blood are formed in the blood; and a flow regulating valve and a flow detecting device are arranged on the gas conveying pipe. The device for inputting the medicine into the veins of the human body can take gas as a carrier, the medicine is loaded through the gas, the gas is absorbed by blood, the medicine takes the gas as the carrier and takes the blood as the carrier, and the gas serving as the carrier is discharged out of physiological or pathological parts through pulmonary circulation. A novel carrier for intravenous administration to a human body is provided for research, development and use of intravenous drugs.

Description

Technical Field

[0001] This application relates to the technical field of medical devices, and more particularly, to a device and method for injecting drugs into a human vein. Background Art

[0002] For hypoxic patients, the methods of supplying oxygen to the human body include supplying oxygen through the respiratory tract, such as nasal cannulas, masks, invasive and non-invasive ventilators, or supplying oxygen through blood vessels, such as using an artificial lung (ECMO) to supply oxygen, or placing a special membrane structure in the blood vessel to supply oxygen, or using a liquid with a high oxygen concentration, or a fluorocarbon emulsion artificial blood, or a low concentration of hydrogen peroxide, or oxygen-containing microparticles, etc.

[0003] However, for the respiratory system with severe diffusion dysfunction, such as ARDS or white lung, supplying 100% pure oxygen through the respiratory tract, such as an invasive ventilator, often cannot meet the oxygen needs of the human body.

[0004] For oxygen supply through blood vessels, the relatively perfect one currently in clinical application is the artificial lung (ECMO), which requires a special membrane structure (hollow fiber) to ensure that oxygen (gaseous state) can pass through the membrane structure and combine with hemoglobin in the blood to form oxygen in a combined state (liquid state), but gaseous oxygen cannot appear in the human circulatory system, veins, arteries or the heart. It is expensive, has high production process requirements, requires the blood to be drawn out of the body for extracorporeal circulation, and has a great interference with the blood system. Summary of the Invention

[0005] The purpose of this application is to provide a device and method for injecting drugs into a human vein, which can solve the above technical problems.

[0006] To achieve the above purpose, the present invention provides a device for injecting drugs into a human vein, which includes a gas source, a gas pipeline, a flow regulating valve, a flow detection device, and a tip for entering the body;

[0007] The gas in the gas source is a gas that can combine with blood in a physical, chemical, and / or biological form; the gas source is connected to the tip for entering the body through the gas pipeline to inject gas into the human vein, and form bubbles that are in direct contact with the blood without being wrapped by other substances in the blood;

[0008] The gas pipeline is provided with a flow regulating valve and a flow detection device.

[0009] In a preferred embodiment, the outer wall of the tip for entering the body has a ring-shaped protrusion and air outlets;

[0010] The number of the ring-shaped protrusions is at least one, and at least one air outlet is provided on both opposite sides of the ring-shaped protrusion.

[0011] In a preferred embodiment, the gas in the gas source is pure oxygen, carbon dioxide gas, or a mixed gas of oxygen and carbon dioxide.

[0012] In a preferred embodiment, the device for injecting drugs into a human vein further includes a drug storage and release device and an infusion pump;

[0013] The infusion pump sends the drug in the drug storage and release device into the gas delivery tube, and enters the human vein along with the gas delivery tube and the body tip.

[0014] In a preferred embodiment, the device for injecting drugs into a human vein further includes:

[0015] A blood oxygen detection device for detecting the blood oxygen saturation of the peripheral vein of the human body;

[0016] An end-tidal carbon dioxide detection device for detecting the content of carbon dioxide exhaled by the human body;

[0017] A B-ultrasound for monitoring the cardiac output, adjusting the flow rate of the gas input into the human vein in real time, and alarming when the monitored cardiac output is lower than the set value;

[0018] The blood oxygen detection device or the end-tidal carbon dioxide detection device is signal-connected to the flow regulating valve, and alarms when it is higher than the set value.

[0019] In a preferred embodiment, the device for injecting drugs into a human vein further includes an ultrasonic device;

[0020] The ultrasonic device is located inside or outside the gas delivery tube, or is part of the tube wall, and can increase the number of bubbles generated by the gas in the gas delivery tube and make the volume of a single bubble smaller.

[0021] The ultrasonic device is used to maintain the dispersed state of the drug in the gas.

[0022] In a second aspect, the present invention further provides a method for injecting drugs into a human vein, directly injecting a gas that combines with blood in a physical, chemical, and / or biological form into the human vein to form bubbles;

[0023] The flow rate of the gas entering the human vein is controlled by a flow regulating valve, thereby affecting the size and number of bubbles, and ensuring that the bubbles disappear before the right ventricle ejects blood.

[0024] In a preferred embodiment, taking the gas in the bubbles as a carrier, carrying the drug that can take blood as a carrier into the blood to form drug-containing bubbles.

[0025] In a preferred embodiment, the way the flow regulating valve regulates the gas entering the human vein is a fluctuating regulation.

[0026] In a preferred embodiment, before the gas enters the blood to form bubbles, the gas flow direction is perpendicular to, obliquely backward or opposite to the blood flow direction.

[0027] By the above technical solution, when the gas in the gas source is oxygen and is used as a drug, pure oxygen is directly input into the human vein through the gas delivery pipe to supply oxygen to the human body. Compared with the current method of supplying oxygen through blood vessels, it is a new method of supplying oxygen through human blood vessels, which is more economical or efficient and does not interfere with the metabolism of human blood and other systems.

[0028] Using carbon dioxide or oxygen as the gas source for the gas input device, or using gas as a carrier to input solid drug particles, aerosol drugs and gaseous drugs into the vein, increases the types of carriers used for inputting drugs into the human vein.

[0029] At the same time, when the technical solution of the present application inputs oxygen into the human vein, it also has the following advantages:

[0030] First, there is no accompanying water. Water, although it is a component of blood, the osmotic pressure of pure water is zero. Injecting a sufficient amount of pure water directly into the blood can cause red blood cells to swell or even rupture, and can also cause water intoxication.

[0031] Second, there is no need to place an external device into the atrium. Placing an external device into the atrium, which is a part of the heart and the source of blood flow dynamics, will surely interfere with the original blood flow dynamics state of the heart (atrium) and increase the risk of blood-borne infection.

[0032] Third, a large number of oxygen molecules bind to hemoglobin simultaneously, with high efficiency. By precisely controlling the production of single-molecule oxygen and water by hydrogen peroxide and catalase in the atrium, it is inevitable that multiple oxygen molecules cannot bind to hemoglobin simultaneously, resulting in low efficiency.

[0033] Fourth, the space for oxygen to bind to hemoglobin is larger and the time is longer. In the present application, the space for oxygen to bind to hemoglobin includes the space of the peripheral veins, systemic veins, vena cava of the human body until before the right atrium, and also increases the corresponding blood flow time. Thus, the possible amount of oxygen input is increased.

[0034] At the same time, when the technical solution of the present application inputs drugs into the human vein, it also has the following advantages:

[0035] First, when developing drugs for intravenous use in humans, there is no need to select and adjust the physical, chemical and biological properties of the drug to ensure that the drug can be carried by a liquid. There is no need to select the type of liquid, adjust the molecular polarity of the drug, encapsulate the drug molecules, etc. during the R & D process, which reduces the R & D difficulty, reduces the R & D cost, and saves the R & D time.

[0036] Second, when applying drugs for intravenous use in humans, the side effects caused by using liquid as the drug carrier are avoided.

[0037] Thirdly, without restricting the total amount of the carrier and without causing excessive input of the carrier, pure drugs are intravenously infused. After oxygen or carbon dioxide gas is absorbed into the blood, the excess part beyond the physiological and pathological levels can be excreted from the lungs, realizing the intravenous infusion of pure drugs without a carrier, which is particularly suitable for patients with heart failure complicated with renal failure. Since carbon dioxide is a physiological product of the human body and the lungs can continuously excrete carbon dioxide, the input rate of carbon dioxide can be controlled and the total amount of carbon dioxide input is not restricted.

[0038] Other features and advantages of the present application will be described in detail in the subsequent specific implementation part. Brief Description of the Drawings

[0039] In order to more clearly illustrate the technical solutions of the embodiments of the present invention, the drawings required for use in the embodiments will be briefly introduced below. It should be understood that the following drawings only show some embodiments of the present invention and should not be regarded as limiting the scope. For those of ordinary skill in the art, other related drawings can be obtained based on these drawings without creative efforts.

[0040] Figure 1 It is a schematic structural diagram of the device for intravenously infusing drugs into the human body provided by the embodiment of the present application.

[0041] Figure 2 It is a schematic diagram of the sinusoidal flow rate of the device for intravenously infusing drugs into the human body provided by the embodiment of the present application.

[0042] Figure 3 It is a schematic diagram of the cosine flow rate of the device for intravenously infusing drugs into the human body provided by the embodiment of the present application.

[0043] Figure 4 It is a schematic diagram of the pulsating flow rate of the device for intravenously infusing drugs into the human body provided by the embodiment of the present application.

[0044] Figure 5 It is a schematic external view of the in-body tip of the device for intravenously infusing drugs into the human body provided by the embodiment of the present application.

[0045] Figure 6 It is a cross-sectional view of the in-body tip of the device for intravenously infusing drugs into the human body provided by the embodiment of the present application.

[0046] Figure 7 It is another schematic structural diagram of the device for intravenously infusing drugs into the human body provided by the embodiment of the present application.

[0047] Icon: 1 - gas source; 2 - gas pipeline; 3 - flow regulating valve; 4 - flow detection device; 5 - tip of the body; 6 - end-tidal carbon dioxide detection device; 7 - alarm; 8 - annular protrusion; 9 - air outlet; 10 - drug storage and release device. Detailed implementation manners

[0048] To make the objectives, technical solutions and advantages of the embodiments of the present invention clearer, the technical solutions in the embodiments of the present invention will be clearly and completely described below with reference to the accompanying drawings in the embodiments of the present invention. Obviously, the described embodiments are some, but not all, of the embodiments of the present invention. The components of the embodiments of the present invention described and illustrated herein can be arranged and designed in a variety of different configurations.

[0049] Therefore, the following detailed description of the embodiments of the present invention provided in the drawings is not intended to limit the scope of the claimed invention, but merely represents selected embodiments of the present invention. All other embodiments obtained by those of ordinary skill in the art based on the embodiments of the present invention without creative efforts shall fall within the scope of protection of the present invention.

[0050] It should be noted that like reference numerals and letters denote like items in the following drawings. Therefore, once an item is defined in one drawing, it does not require further definition and explanation in subsequent drawings.

[0051] In the description of the present invention, it should be noted that the terms "center", "upper", "lower", "left", "right", "vertical", "horizontal", "inner", "outer", etc. indicate the orientation or positional relationship based on the orientation or positional relationship shown in the drawings, or the orientation or positional relationship in which the inventive product is customarily placed during use. It is only for the convenience of describing the present invention and simplifying the description, and does not indicate or imply that the device or element referred to must have a specific orientation, be constructed and operated in a specific orientation, and thus should not be construed as a limitation of the present invention. In addition, the terms "first", "second", "third", etc. are only used for descriptive distinction and should not be construed as indicating or implying relative importance.

[0052] In addition, the terms "horizontal", "vertical", "overhanging", etc. do not mean that the components are required to be absolutely horizontal or overhanging, but can be slightly inclined. For example, "horizontal" only means that its direction is more horizontal relative to "vertical", and does not mean that the structure must be completely horizontal, but can be slightly inclined.

[0053] In the description of the present invention, it should also be noted that, unless otherwise clearly specified and defined, the terms "arrangement", "installation", "connection", and "coupling" should be understood in a broad sense. For example, it may be a fixed connection, a detachable connection, or an integral connection; it may be a mechanical connection or an electrical connection; it may be a direct connection or an indirect connection through an intermediate medium, and it may be the communication inside two components. For those of ordinary skill in the art, the specific meanings of the above terms in the present invention can be understood according to specific circumstances.

[0054] In the existing transvascular oxygen supply technologies, there are artificial lungs, inserting oxygen delivery tubes into veins for oxygen delivery, placing a dedicated membrane structure in blood vessels for oxygen supply, or using high-oxygen-concentration liquids, or fluorocarbon emulsion artificial blood, oxygen-encapsulated microparticles, low-concentration hydrogen peroxide, or in-situ oxygen generation in the atrium, etc.

[0055] Among them, in the technical solutions disclosed in some patent documents, there is a solution of inserting an oxygen delivery tube into a human vein for oxygen delivery. However, in its way of venous blood vessel oxygen supply, it is required to ensure that there are no pure free gases in the blood, including oxygen bubbles (oxygen-containing microparticles are oxygen-containing liquid droplets, belonging to the liquid phase), to prevent their accumulation in blood vessels to form gas embolisms. It is described in its specification that: to further effectively control the oxygen flow rate and improve the oxygenation efficiency, so as not to cause the formation of oxygen bubbles in the venous blood vessels or too low oxygen content in the blood due to too much or too little oxygen in the venous oxygen delivery tube, when the cross-sectional area of the venous oxygen delivery tube is 0.6 - 0.8 of the cross-sectional area of the venous blood vessel, the wall thickness of the venous oxygen delivery tube is 3 / 4 to 4 / 5 of the outer diameter of the venous oxygen delivery tube, the oxygen content in the blood is the highest, and at the same time, no oxygen bubbles are generated. Setting the oxygen delivery channel as a curved shape and connecting it with the oxygen delivery holes can further slow down the oxygen flow rate and improve the oxygenation efficiency.

[0056] The damage of gas embolism diseases to the human body is mainly reflected in two aspects: gas embolizing blood vessels causes tissue and organ ischemia and hypoxia, and the impact of bubbles on the heart pump function. Basic nursing also requires that when performing intravenous infusion treatment on the human body, it is required to try to remove the air in the infusion tube and the needle. There is a dedicated gas detection device on hemodialysis instruments to prevent gas from entering the human blood vessels. It only detects gas and does not distinguish the types of gas. The alarm range is 10 - 500 μL for a single bubble, and the cumulative bubble alarm volume is 20 - 500 μL, with a cumulative time ≥ 1 min.

[0057] It is generally believed that if gas directly enters the blood, there is a risk of gas embolism disease, even death, and it is an iatrogenic accident. Therefore, current diagnostic and treatment technical solutions do not allow gas to directly enter the blood, or minimize it as much as possible. When bubble contrast agents and oxygen microparticles enter the blood, they also enter in the form of a liquid phase encapsulating the gas. Oxygen is also a gas and is no exception. For the method of vascular oxygen supply, such as extracorporeal membrane oxygenation (ECMO), placing a special membrane structure in the blood vessel for oxygen supply, or using a liquid with a high oxygen concentration, or perfluorocarbon emulsion artificial blood, or low-concentration hydrogen peroxide, or inserting an oxygen delivery tube into the vein for oxygen delivery, etc., are all designed based on this view.

[0058] In the existing technical literature on intravenous drug administration and vascular oxygen supply to the human body, it is believed that after free gas enters the vein, it may pose a risk of gas embolism to the human body. Therefore, it is necessary to try to expel the free gas in the blood in the pipeline, or encapsulate the gas in a liquid phase, chemically combine the gas in a liquid phase (hydrogen peroxide decomposes into water and oxygen after entering), or generate single oxygen molecules that can be immediately absorbed in the right atrium (not the vein) and other methods to avoid the risk of gas embolism disease. The current technical method is to avoid or maximize the avoidance of gas entering the blood to form bubbles to avoid gas embolism disease.

[0059] However, the technical solution of the present invention precisely overcomes the above technical prejudice and provides a new way of vascular oxygen supply to the human body, and designs a device for injecting drugs into the human vein, such as Figure 1As shown in the figure, it includes a gas source 1, a gas pipeline 2, a flow regulating valve 3, a flow detection device 4 and a body entry tip 5; the gas in the gas source is a gas that can combine with blood in a physical, chemical and / or biological form. This gas is connected to the body entry tip through the gas pipeline to input the gas into the human vein, forming bubbles that are in direct contact with the blood without being wrapped by other substances in the blood. And in the systemic venous system, before the right ventricle ejects blood, the gas combines with the blood in a physical, chemical and / or biological form, and the bubbles disappear, or basically disappear. Then, in the pulmonary circulation, the part required by physiology continues to circulate as required by physiology, and the part exceeding physiology or pathological needs is discharged from the alveoli. In this technical solution, a gas that can be rapidly and residue-free absorbed by the blood is selected and input into the human venous system to form bubbles. This gas is absorbed by the blood in the venous system and the right atrium and right ventricle. Before the right ventricle ejects blood, the bubbles disappear or basically disappear, avoiding the impact of the bubbles on the heart pumping function, and at the same time avoiding the damage of the bubbles to the distal organs in gas embolism diseases, that is, avoiding the damage of gas embolism diseases. Finally, the excess gas is excreted through the lungs. This technical solution actively inputs gas into the human venous blood vessels, actively generates bubbles in the venous blood, and in the position space of the human veins, right atrium and right ventricle, within the time range when the blood flows from the peripheral veins to the right ventricle, by utilizing the absorption of the gas by the venous blood to eliminate the bubbles, so as to avoid gas embolism diseases, and uses end detection methods, such as blood oxygen saturation detection, end-tidal carbon dioxide examination and cardiac output detection, etc., as safety protection measures. During the formation and disappearance of the bubbles, drugs, including oxygen, are carried in to complete the function of the drug carrier.

[0060] In this embodiment, when the gas in the gas source is oxygen, the gas source is an oxygen pump, which is connected to the body entry tip 5 through the gas pipeline 2 to input pure oxygen into the human vein, forming pure oxygen bubbles that are in direct contact with the blood without being wrapped by other substances in the blood; a flow regulating valve 3 and a flow detection device 4 are arranged on the gas pipeline 2.

[0061] In this embodiment, the device for inputting drugs into the human vein breaks the technical prejudice that the appearance of gas in the human vein will cause gas embolism. By utilizing the physiological characteristic that oxygen can be rapidly and residue-free absorbed by hemoglobin, pure oxygen bubbles are used to supply oxygen to the human body. Compared with the current transvascular oxygen supply method, it is more economical or efficient and does not interfere with the human blood and other systems.

[0062] If the gas is limited to oxygen, especially oxygen with a purity of 99.99% or above, since oxygen can rapidly bind to hemoglobin in less than 0.01 seconds, then, usually, the damage caused by gas embolism in blood vessels is tissue and organ ischemia and hypoxia, which will disappear because oxygen is rapidly absorbed by hemoglobin. The impact of air bubbles on the heart pump function will also disappear because pure oxygen bubbles are rapidly absorbed by hemoglobin. Then, if the speed of oxygen is strictly controlled, the number of oxygen bubbles is increased, and the absorption area is increased, without reducing the heart pump function or within the adjustable range allowed by the heart pump function, oxygen can be directly infused into the human vein, and oxygen bubbles are allowed to appear in the blood without causing damage to the human body.

[0063] When oxygen bubbles appear in the blood, they can enter the blood more directly than oxygen supply through the respiratory tract, which needs to pass through the respiratory membrane, avoiding the diffusion dysfunction caused by the thickening of the respiratory membrane. Through structures such as the flow regulating valve, the tip of the porous structure, and the annular protrusion 8, the number of oxygen bubbles is increased as much as possible, the size of oxygen bubbles is reduced, the contact area between oxygen and hemoglobin is increased, and the overall oxygen absorption time is shortened. Since there is no morphological sense when air bubbles flow rapidly, they are easily broken and shunted at the blood vessel branch. The more broken they are, the larger the surface area of oxygen bubbles and the shorter the absorption time.

[0064] From the peripheral veins of the human body to the systemic veins, the superior and inferior vena cava, the right atrium, and the right ventricle can all be the positions where oxygen is absorbed into the blood. In the peripheral veins of the human body, especially the distal peripheral veins of the lower extremities, the blood return partly depends on the muscle pump and is affected by gravity, which prolongs the time for blood to return to the heart and increases the oxygen absorption time. Multiple annular protrusions 8, porous structures, and microporous structures at the tip of the infusion body promote the increase in the number of oxygen bubbles and the reduction in the volume of a single oxygen bubble. Oxygen infusion at multiple points reduces the requirement for the oxygen supply to a single human vein under the condition of constant overall oxygen supply.

[0065] By infusing oxygen bubbles into the human vein, the following benefits are obtained:

[0066] First: The process of oxygen being absorbed by hemoglobin is more direct and rapid without the barrier of the outer wall of anaerobic microdroplets.

[0067] Second: Oxygen is a normal component of blood and can be rapidly and completely absorbed by blood, avoiding the metabolic impact of the outer wall of oxygen microdroplets on the human blood system and other systems.

[0068] Third: There is no process of oxygen being wrapped by a liquid phase object.

[0069] In this embodiment, the gas source 1 is a central oxygen supply source, an oxygen pump, or an oxygen tank, and its internal pressure is greater than the atmospheric pressure. When oxygen is infused into the human vein through the gas transmission pipe 2 and the infusion body tip 5, automatic oxygen infusion can be carried out without other power-assisted devices.

[0070] However, due to the relatively high pressure in the central oxygen supply source, oxygen pump or oxygen tank, the pressure needs to be regulated to avoid causing harm to the human body due to too fast an entry speed. In this embodiment, a flow regulating valve 3 is provided on the gas transmission pipe 2 to regulate the oxygen delivery flow rate.

[0071] Specifically, in this embodiment, the human body has a certain rate tolerance limit for oxygen delivery. To avoid too high a flow rate during oxygen delivery, the flow regulating valve 3 is provided with a limit on the maximum opening degree to limit the upper limit of the flow rate during oxygen delivery and reduce the risk to the human body.

[0072] In this embodiment, in order to ensure the control of the amount of pure oxygen input into the human vein, a flow control device is added to the gas transmission pipe 2, which can monitor the amount of oxygen input into the body in real time.

[0073] In a preferred embodiment, as Figure 5 and Figure 6 shown, the outer wall of the body insertion tip has an annular protrusion 8 and a pure oxygen outlet hole 9; the number of the annular protrusions 8 is at least one, and at least one of the pure oxygen outlet holes 9 is provided on both opposite sides of the annular protrusion 8.

[0074] In this embodiment, after the annular protrusion 8 is provided on the outer wall of the body insertion tip, it can cause the blood to form a turbulent flow when flowing in the vein. At this time, when the pure oxygen is discharged through the pure oxygen outlet hole 9, the number of oxygen bubbles can be increased, the volume of a single oxygen bubble can be reduced, and pure oxygen bubbles with a smaller volume and not wrapped by other substances and in direct contact with the blood are formed, which is more convenient for binding with hemoglobin.

[0075] Specifically, in this embodiment, there is at least one pure oxygen outlet hole 9 between two adjacent annular protrusions 8. Thus, under the condition that the total volume of oxygen entering the blood remains unchanged, the position where the pure oxygen enters the vein can be dispersed, so that the number of pure oxygen bubbles is more, the volume of a single oxygen bubble is smaller, and the overall contact area with the blood is larger.

[0076] Taking the femoral vein as an example, with a laminar flow velocity of 15 centimeters per second as the reference condition, the dispersion and absorption process of 5 milliliters of gas in the blood is discussed from a theoretical perspective.

[0077] On a hollow needle with a diameter of 2 mm, the outer diameter circumference is 6.28 mm, the annular interval arc is 30 degrees, 12 holes are drilled, the diameter of the air outlet hole is 0.03 mm, and 12 annular holes are drilled every 0.5 mm. A total of 60 annular holes are continuously drilled, and the annular length is 30 mm, for a total of 720 holes. Gas enters the blood through 720 circular micropores with a diameter of 0.03 mm, is injected at a speed of 5 ml per second, is injected perpendicular to the blood flow direction, and the time required for the blood flow (150 mm per second) to pass through the air hole (diameter 0.03 mm) is the bubble detachment time. Divide the total volume of 5 ml by the time to obtain the overall flow rate, and then divide by 720 holes to calculate the single-hole gas flow rate. Multiply the single-hole gas flow rate by the bubble detachment time to obtain the volume of a single bubble. Assume that the bubble is a perfect sphere, the total number of bubbles is 365,000, and the diameter of a single bubble is 0.3 mm, with a surface area of approximately 100,000 square millimeters.

[0078] The diameter of adult alveoli (0.2 - 0.3 mm) is counted as 0.2 mm. Assume that the alveoli are perfect spheres. For the same number of alveoli, their surface area is 150,000 square millimeters. That is, for the same volume of gas, the surface area of the oxygen bubbles (hereinafter referred to as oxygen bubbles) generated by the technical solution of this embodiment, compared with the surface area formed by the gas in the pulmonary alveoli, the surface area of the alveoli is 1.5 times that of the oxygen bubbles. The volume of the unilateral femoral vein and the inferior vena cava is approximately 140 ml, which is equivalent to the pulmonary circulation volume.

[0079] The influencing factors of pulmonary gas exchange include gas partial pressure difference, diffusion area, diffusion distance, temperature, and ventilation / perfusion ratio, etc. In the lungs, the oxygen partial pressure is 21% of the atmospheric pressure (the volume ratio of oxygen in the air). In the blood, the oxygen partial pressure of pure oxygen bubbles is 100% of the atmospheric pressure, that is, 5 times the oxygen partial pressure in the lungs. Therefore, in the blood, the oxygen diffusion rate in the oxygen bubbles should be 5 times the oxygen-blood binding rate in the lungs.

[0080] In terms of the diffusion distance comparison, the lungs have a respiratory membrane, while the oxygen bubbles have no respiratory membrane to isolate oxygen from the blood.

[0081] In terms of temperature comparison, the lungs are the same as the oxygen bubbles.

[0082] In terms of the ventilation / perfusion ratio comparison, the ventilation / perfusion ratio in the lungs is 0.84. The volume of the unilateral femoral vein and the inferior vena cava is approximately 140 ml, which is equivalent to the pulmonary circulation volume. The difference in arteriovenous oxygen content is 7 ml of oxygen, which is greater than the gas volume of 5 ml and can be completely absorbed. In the lungs, the oxygen-blood binding takes 0.3 seconds. The oxygen bubble generation time is 1 second, which is 3 times the oxygen-blood binding time in the lungs.

[0083] In summary, it can be theoretically speculated that the oxygen bubbles generated in 1 second can be absorbed within 1 second. They are completely absorbed into the blood before the right ventricular ejection, without affecting cardiac ejection, and even less likely to cause ischemia and hypoxia in distal tissues, and no damage caused by gas embolism diseases occurs. The oxygen consumption of an adult at rest is about 250 ml / min. According to this method, calculated at 5 ml per second, 300 ml of oxygen can be provided per minute in 60 seconds. Moreover, the oxygen bubbles can be completely absorbed into the blood before the right ventricular ejection, without affecting cardiac ejection, and even less likely to cause ischemia and hypoxia in distal tissues, and no damage caused by gas embolism diseases occurs, showing the potential for clinical application.

[0084] In this embodiment, the direction when injecting pure oxygen gas into the human body is described as perpendicular to the blood flow direction. It can also be set to be obliquely backward or in the opposite direction of the blood flow, that is, injecting pure oxygen gas at an obtuse angle or in the reverse direction to the blood flow direction, which can reduce the volume of pure oxygen bubbles.

[0085] In a preferred embodiment, the device for injecting drugs into the human vein of the human body further includes a blood oxygen detection device for detecting the blood oxygen saturation of the human body; the blood oxygen detection device is signal-connected to the flow regulating valve 3.

[0086] In this embodiment, through the setting of the blood oxygen detection device, the blood oxygen saturation in the body of the patient using the device for injecting drugs into the human vein of the human body can be monitored in real time to avoid too high blood oxygen saturation. If the venous blood oxygen saturation is high, the oxygen supply should be reduced to prevent the oxygen in the blood from being supersaturated and overflowing to form bubbles, causing gas embolism diseases.

[0087] When the venous blood oxygen saturation of the patient exceeds the dangerous threshold, an adjustment signal is sent to the flow regulating valve 3 to reduce the opening degree of the flow regulating valve 3 or close the flow regulating valve 3.

[0088] In this embodiment, the dangerous threshold of the patient's venous blood oxygen concentration is less than the maximum tolerable value of the human blood oxygen concentration. That is, when the maximum tolerable limit of the human blood oxygen concentration is a, the dangerous threshold b set on the blood oxygen detection device is less than a, so as to give time for the flow regulating valve to adjust the speed and reduce the risk caused by untimely adjustment.

[0089] In a preferred embodiment, the device for injecting drugs into the human vein of the human body also uses B-ultrasound to monitor the cardiac output, and adjusts the flow rate of pure oxygen input into the human vein in real time. When the monitored cardiac output is lower than the set value, an alarm is issued.

[0090] In this embodiment, by monitoring the cardiac output with B-ultrasound, the cardiac output can be prevented from being too low. If the cardiac output is too low, it may be caused by the incomplete absorption of oxygen bubbles, or it may be due to the decrease in venous flow rate caused by low cardiac output, resulting in an increase in the volume of generated oxygen bubbles and inability to be absorbed within the corresponding time, forming bubbles and causing gas embolism diseases.

[0091] In a preferred embodiment, an alarm 7 is connected to the blood oxygen detection device.

[0092] In this embodiment, the alarm 7 and the blood oxygen detection device are connected by a wire, and signals are transmitted through the wire connection to reduce signal interference and ensure the timeliness of the alarm.

[0093] It can be understood that the signal transmission mode between the alarm 7 and the blood oxygen detection device can be a wire connection, or can have both a wire connection and a wireless connection, so as to further ensure the timeliness of the alarm.

[0094] In this embodiment, there are many ways for the alarm 7 to give an alarm.

[0095] Specifically, the alarm mode of the alarm 7 can be a sound and light alarm, or a vibration alarm, or a combination of sound and light and vibration, or can also be to add a voice alarm and other methods.

[0096] In a preferred embodiment, the device for injecting drugs into the human vein further includes an ultrasonic device; the ultrasonic device is located inside or outside the gas delivery tube, or is part of the tube wall, and can increase the number of pure oxygen bubbles produced by the oxygen in the gas delivery tube and reduce the volume of a single bubble.

[0097] Specifically, in this embodiment, the ultrasonic device can be installed inside the gas delivery tube, or can be installed outside the gas delivery tube, or can also act on the tube wall of the infusion tube and be part of the tube wall. By sending ultrasonic waves, the number of pure oxygen bubbles is increased and the volume of a single pure oxygen bubble is reduced.

[0098] The present invention also provides a method for injecting drugs into the human vein, that is, directly injecting into the human vein a gas that can combine with blood in a physical, chemical, and / or biological form to form bubbles;

[0099] The gas flow rate into the human vein is controlled by a flow regulating valve, thereby affecting the size and number of bubbles, and ensuring that the bubbles disappear before the right ventricle ejects blood.

[0100] In this embodiment, a gas that combines with blood in a physical, chemical, and / or biological form is directly injected into the human vein to form bubbles. During the blood flow process in the peripheral vein, systemic vein, vena cava, and right atrium and right ventricle of the human body, the gas combines with the blood in a physical, chemical, and / or biological form, the gas dissolves in the blood, the bubbles disappear, and the gas is transported by the blood in the blood.

[0101] The gas flow rate into the human vein is controlled by a flow regulating valve, thereby affecting the size and quantity of the bubbles, so as to ensure that the bubbles disappear, or basically disappear, before the right ventricle ejects blood. In the pulmonary circulation, the physiologically required part of the gas continues to circulate according to physiological needs, and the part exceeding physiological or pathological needs is discharged from the alveoli.

[0102] Specifically, in this embodiment, pure oxygen can be directly input into the human vein as a drug, that is, pure oxygen is directly input into the human vein to form oxygen bubbles, which combine with hemoglobin during the blood flow process in the peripheral vein, systemic vein, vena cava, right atrium and right ventricle of the human body. The flow rate of pure oxygen entering the human vein and the size and quantity of pure oxygen bubbles are controlled by the flow regulating valve 3.

[0103] In this embodiment, pure oxygen is directly input into the human vein through the gas delivery tube 2 by using a medical needle or a medical needle with micropores processed, forming oxygen bubbles in the vein, and the oxygen bubbles combine with hemoglobin to increase the blood oxygen concentration.

[0104] Specifically, in this embodiment, the flow rate of oxygen delivery is regulated by the flow regulating valve 3 to avoid the danger caused by too high a flow rate.

[0105] More specifically, in this embodiment, pure oxygen is directly input into the human vein to form oxygen bubbles, which combine with hemoglobin during the normal blood flow process in the peripheral vein, systemic vein, vena cava, right atrium and right ventricle of the human body. The flow rate of pure oxygen entering the vein is controlled by the flow regulating valve, and then the size and quantity of pure oxygen bubbles are affected by structures or devices such as porous structures, annular protrusions and ultrasonic waves. The oxygen bubbles are gradually absorbed by hemoglobin during the blood flow process, and the gaseous state is transformed into the liquid phase combined with hemoglobin, and the bubbles disappear. That is, it is not that the current technical prejudice requires that bubbles are not allowed to appear in the blood, but that bubbles are created in the venous blood, and at the same time, the bubbles are controlled to disappear before the right ventricle ejects blood, thereby eliminating the influence of oxygen bubbles on tissue vascular embolism and also eliminating the influence of pure oxygen bubbles on blood flow dynamics, or controlling its influence within the range permitted by blood flow dynamics.

[0106] In the preferred embodiment, the way for the flow regulating valve 3 to regulate the pure oxygen entering the human vein is fluctuating regulation and high-frequency switch injection.

[0107] When the gas entering the blood is pure oxygen, it does not contain gases such as nitrogen that are harmful to the human body, avoiding the damage to organs caused by gas embolism due to the non-absorbability of nitrogen. At the same time, when reducing the volume of oxygen bubbles, the surface area of oxygen bubbles in the blood can also be increased, reducing the absorption time and the impact on the heart pump function.

[0108] In this embodiment, the flow regulating valve 3 can increase the number of oxygen bubbles and reduce the volume of oxygen bubbles through fluctuating regulation, that is, the oxygen bubbles will be smaller, thereby increasing the contact area between the pure oxygen entering the blood and the blood.

[0109] Specifically, in this embodiment, by controlling the input amount of oxygen through a high-frequency switch to generate changes and forming oxygen supply during fluctuations, the pure oxygen bubbles will become smaller, thereby increasing the number of pure oxygen bubbles and reducing the volume of a single pure oxygen bubble.

[0110] It should be noted that in this embodiment, the regulation method of the flow regulating valve 3 is fluctuating regulation, but it is not limited to fluctuating regulation. It can also be other regulation methods as long as the volume of oxygen bubbles can be reduced through the regulation of the flow rate.

[0111] In a preferred embodiment, the fluctuating regulation is sinusoidal regulation, cosine regulation or pulse regulation.

[0112] In this embodiment, when the flow regulating valve 3 is a mechanical regulating valve, the fluctuating regulation method can be to reciprocally regulate the opening degree of the flow regulating valve 3 to form a regulation with a sine function or cosine function waveform, as shown in Figure 2 and Figure 3 shown; when the flow regulating valve 3 is an electronic regulating valve, the fluctuating regulation can be achieved by repeatedly and alternately opening and closing to perform pulse regulation, forming a square wave as shown in Figure 4 shown.

[0113] It can be understood that in this embodiment, the fluctuating regulation method can be the above several methods, but it is not limited to the above several methods. It can also be other regulation methods, such as triangular wave regulation, etc. That is to say, as long as the fluctuating regulation can be achieved.

[0114] In a preferred embodiment, the position where pure oxygen is input into the human vein is the lower limb, specifically at the peripheral vein or femoral vein of the lower limb.

[0115] In this embodiment, when pure oxygen is input into the human vein through the lower limb, it takes a certain amount of time to enter the human heart, thereby increasing the binding time between pure oxygen and hemoglobin and reducing the impact of pure oxygen bubbles on the heart pump function.

[0116] At the same time, when any danger occurs, it can give the medical staff reaction time for timely operation and improve the safety of use.

[0117] In this embodiment, when pure oxygen is introduced into the human vein, it can be input simultaneously at multiple locations, so as to reduce the oxygen supply of a single venous vessel, increase the number of oxygen bubbles, increase the contact time between oxygen and hemoglobin, quickly increase the blood oxygen concentration of the human body, and reduce the impact of oxygen bubbles on the heart pump function under the condition of constant overall oxygen supply.

[0118] In a preferred embodiment, a blood oxygen detection device is connected to the flow regulating valve 3, and the flow rate of pure oxygen input into the vein is adjusted in real time according to the blood oxygen saturation of the human body feedback by the blood oxygen detection device.

[0119] In this embodiment, the blood oxygen detection device performs real-time blood oxygen detection on the patient in need of oxygen infusion to monitor the blood oxygen saturation of the patient and avoid the danger caused to the patient by excessive blood oxygen saturation.

[0120] Specifically, in this embodiment, when the venous blood oxygen saturation monitored in real time is too high, the flow regulating valve 3 is closed or the flow rate is reduced; when the venous blood oxygen saturation monitored in real time is too low, the opening degree of the flow regulating valve 3 is increased to accelerate oxygen infusion, so as to quickly increase the blood oxygen saturation of the human body.

[0121] In this embodiment, the blood oxygen detection device is a blood oxygen detector, which can monitor the venous blood oxygen saturation of the patient in real time and accurately.

[0122] When the blood oxygen detection device monitors that the venous blood oxygen saturation exceeds the standard, it is necessary to reduce the opening degree of the flow regulating valve 3, thereby reducing the oxygen infusion speed, and since the flow regulating valve 3 is an immediate response, abnormalities will not persist under normal circumstances.

[0123] In a preferred embodiment, the oxygen concentration of the pure oxygen is above 99.99%.

[0124] When directly inputting pure oxygen into the human vein, it is necessary to ensure the concentration of pure oxygen to avoid the occurrence of danger caused by the increase in the content of other gases.

[0125] Through the above technical solution, pure oxygen is directly input into the human vein by the gas delivery pipe 2 to supply oxygen to the human body, reduce costs, or increase the blood oxygen efficiency.

[0126] It should be noted that, without conflict, the features in the embodiments of the present application can be combined with each other.

[0127] For the research and development of intravenous drugs for human use, it is necessary to use a liquid as a carrier. In the auxiliary processes such as the selection of the liquid carrier type, the adjustment of the drug molecular polarity, and the encapsulation of the drug molecules, it generally accounts for about 3 to 5% of the new drug development cost. When applying intravenous drugs for human use, the side effects of using a liquid as the drug carrier are avoided. For example, for drugs that are insoluble in water, the allergic and toxic reactions of the organic solvents that are forced to be used, and the requirements for a specific pH value, etc. For patients with heart failure complicated with renal failure, the restriction on liquids is extremely strict. As the liquid serving as the drug carrier, affected by factors such as drug solubility, osmotic pressure, and pH value, a large amount of liquid serving as the carrier, such as normal saline, has to be input when the drug is input. For normal saline, 99% is water and 0.9% is sodium chloride, which aggravates heart failure. And the excretion of these liquids requires the kidneys, and in the case of renal failure, the excretion is difficult, thus forming a vicious cycle.

[0128] Currently, liquids are used as carriers for drugs administered intravenously. However, some drugs cannot be dissolved in conventional crystalloid solutions or colloid solutions such as normal saline and glucose solution. For example, hydrocortisone injection uses ethanol as the solvent, usually 50% ethanol, and needs to be slowly infused intravenously (to avoid central inhibition), is contraindicated in children, those with alcohol allergy or liver insufficiency, and is prohibited from being used in combination with cephalosporins to prevent disulfiram-like reactions. The solvent for vitamin K1 is Tween 80 and propylene glycol, which may cause allergies, hemolysis or local irritation. For drugs in the fields of anti-tumor drugs, immunosuppressants and lipophilic drugs, their solvents achieve solubilization through surfactants, cyclodextrins or fat emulsions, but this also brings risks such as allergies and toxicity. Some drugs can be dissolved in crystalloid solutions, but have clear requirements for the pH value and there are drug interactions. For drugs required for solutions with different pH values and drugs with drug interactions, when they are in the same channel, there will be phenomena such as drug crystallization or mutual reaction precipitation and they cannot enter the blood along with the solution. And doctors often encounter such situations when facing critically ill patients and are forced to adjust in ways such as in different time periods and through different channels. For patients with strict liquid restrictions, the liquid serving as the carrier will also cause the patient to have an excessive volume load and induce heart failure.

[0129] The current medical view holds that the entry of gas into the blood may lead to gas embolism diseases. The damage of gas embolism diseases to the human body is mainly reflected in two aspects: gas embolizing blood vessels causing tissue and organ ischemia and hypoxia and the impact of bubbles on the heart pump function. Therefore, basic nursing requires that when treating patients by intravenous drug infusion for human use, it is necessary to try to exclude the air in the infusion tube and the needle. There are special gas detection devices on hemodialysis instruments to prevent gas from entering the human blood vessels. It only detects gas and does not distinguish the types of gas. The alarm range is 10 - 500 μL for a single bubble, and the cumulative bubble alarm volume is 20 - 500 μL with a cumulative time ≥ 1 min. The appearance of bubbles is strictly prohibited in the blood circulation pipeline of ECMO.

[0130] Based on the above problems, the present invention provides a device for injecting drugs into the human vein. By applying this device, oxygen or carbon dioxide gas is used as the carrier of the drug, thereby solving the above problems.

[0131] As Figure 1 shown, it includes a gas source 1, a gas transmission pipe, a flow regulating valve, a flow detection device, and a tip for entering the body. The auxiliary devices are end-tidal carbon dioxide detection and B-ultrasound. The gas in the gas source 1 is a mixed gas of solid particles, atomized liquid, or gaseous drug and carbon dioxide. The drug-containing mixed gas enters the blood along the gas transmission pipe.

[0132] Or, as Figure 7 shown, it includes a gas source 1, a gas transmission pipe, a flow regulating valve, a flow detection device, a drug storage and release device 10, and a tip for entering the body. The auxiliary devices are end-tidal carbon dioxide detection and B-ultrasound. The gas in the gas source 1 is a gas that can combine with blood in a physical, chemical, and / or biological form, which is pure oxygen, carbon dioxide gas, or a mixed gas of oxygen and carbon dioxide in a certain proportion.

[0133] Specifically, in this embodiment, carbon dioxide is used as the gas. The speed at which carbon dioxide gas enters the blood is nearly twenty times that of oxygen, that is, it is more easily absorbed by the blood than oxygen bubbles.

[0134] The drug storage and release device 10 contains drugs. These drugs have the property of being able to combine with blood in a physical, chemical, and / or biological form. Their forms can be solid particles, atomized liquid, or gas, and they can be dispersed in the gas. They are injected into the gas transmission pipe by a pump-controlled syringe and enter the blood along with the gas in the gas transmission pipe.

[0135] Specifically, in this embodiment, a gas that can combine with blood in a physical, chemical, and / or biological form is directly injected into the human vein, and this gas is used as a carrier to carry drugs that can use blood as a carrier into the blood, forming drug-containing bubbles. During the blood flow in the peripheral veins, systemic veins, vena cava, right atrium, and right ventricle of the human body, the gas in the bubbles combines with the blood in a physical and / or chemical form, and the drugs combine with the blood in a physical, chemical, and / or biological form. The bubbles disappear, and both the gas and the drugs are in the blood and are transported by the blood. The gas flow rate entering the human vein is controlled by the flow regulating valve, thereby affecting the size and quantity of the bubbles, so as to ensure that the bubbles disappear, or basically disappear, before the right ventricle ejects blood. This gas is in the pulmonary circulation. The physiologically required part continues to circulate according to physiological needs, and the part exceeding physiological or pathological needs is discharged from the alveoli.

[0136] In this embodiment, the drug is glucose powder, in granular form, with a specific gravity of 1.56 g / cm 3 , less than 3 g / cm 3, with a diameter of 5 microns, in a suspended state. The carbon dioxide gas containing the suspended drug is pushed by a pump and enters the gas transmission pipe 2. Together with the carbon dioxide gas from the gas source, it flows into the human vein through the flow regulating valve 3, the flow detection device 4 and the body tip 5, forming carbon dioxide bubbles containing glucose powder in the human body.

[0137] If it is transported by means of industrial pneumatic conveying, in dilute phase transportation, with a gas flow rate of 30 m / s and 5-micron solid particles, calculated according to the solid-gas mass ratio of 10 - 15 kg / kg (referring to the power plant fly ash transportation plan), about 60 ml of carbon dioxide gas is required to transport 1 g of glucose.

[0138] Under the resting condition of the human body, 200 ml of carbon dioxide is excreted per minute, with a large elastic space. Therefore, the input carbon dioxide can be excreted through the pulmonary circulation.

[0139] Most modern industrial drugs are measured in milligrams. For example, hydrocortisone is used in emergencies such as anaphylactic shock and status asthmaticus:

[0140] Initial dose: 100–200 mg, repeated every 6–8 hours as needed (or continuous infusion), with a total daily dose of 1000 mg and a specific gravity of 1.3 g / cm 3 , less than 3 g / cm 3 .

[0141] The usual dosage of paclitaxel is 200 - 500 mg each time (the human body surface area is calculated as 1.7 square meters), once every 3 weeks, with a specific gravity of 1.2–1.3 g / cm 3 , less than 3 g / cm 3 , that is, according to the solid-gas mass ratio, 60 ml of carbon dioxide gas can transport the human usage amount of the above drugs.

[0142] According to the theory of gas embolism diseases, the consequences of air entering the blood circulation depend on the speed and amount of gas entering. A small amount of gas entering the blood can be dissolved in the blood without embolism. For example, a large amount of gas (>100 ml) can lead to sudden death and the clinical manifestations of gas embolism diseases. Injecting air at a speed of 0.05 ml / Kg / min can cause changes in heart sounds. Injecting air at a speed of 2 ml / Kg / min can cause a decrease in end-expiratory carbon dioxide concentration and an increase in pulmonary artery pressure, often leading to death. Rapid injection of a large amount of air (3 - 8 ml / kg) can be immediately fatal. Injecting 40 ml of air into the vein can cause death.

[0143] It is thus speculated that the gas is pushed in pulsatile manner, with the flow rate controlled to push in 3 ml of carbon dioxide gas within one second, and then stopped for 59 seconds. Pushing in air at 0.05 ml / Kg / min (for a body weight of 60 Kg, i.e., 3 ml) is the dose estimation for the change in heart sound. When the gas type is changed to carbon dioxide that can be absorbed by blood at a speed more than twenty times that of oxygen (carbon dioxide dissolves in blood 20 times faster than oxygen, and nitrogen does not dissolve in blood), it should be completely absorbed by blood without gas embolism occurring, and then stopped for 59 seconds to expel the pushed-in carbon dioxide gas. The pipe diameter is controlled to be about 0.36 mm, and then the flow rate is controlled to reach 30 m / s. This is repeated 20 times, and the input of 1 g of drug can be completed within 20 minutes without generating gas embolism diseases and without carbon dioxide retention caused by the injection of carbon dioxide.

[0144] The end-tidal carbon dioxide detection device 6 detects the end-tidal carbon dioxide, that is, the carbon dioxide exhaled by the human body. When the end-tidal carbon dioxide exceeds the standard, alarm processing is carried out, and the operator operates or automatically operates to control the flow regulating valve to reduce the flow rate.

[0145] In this embodiment, the cardiac output is monitored by B-ultrasound to avoid too low cardiac output. If the cardiac output is too low, it may be caused by incomplete absorption of carbon dioxide bubbles, or it may be due to the decrease in venous flow rate caused by low cardiac output, resulting in an increase in the volume of carbon dioxide bubbles and incomplete absorption within the corresponding time, forming bubbles and causing gas embolism diseases.

[0146] The blood oxygen detection device or the end-tidal carbon dioxide detection device is signal-connected to the flow regulating valve, and an alarm is given when it is higher than the set value.

[0147] It is also possible to use ultrasonic waves to maintain the dispersed state of drugs in a larger particle state inside the drug storage and release device and during the transmission process. It is also possible to use an electric field or a magnetic field to assist in maintaining the dispersed state of drugs in a larger particle state. It is also possible to control the input speed of drugs, the solid-gas mass ratio, etc. by adjusting the gas flow rate within the allowable flow range.

[0148] The device for injecting drugs into the human vein provided by the present invention does not need to select the liquid type, adjust the molecular polarity of the drug, wrap the drug molecules, etc. due to the solubility of the drug in the liquid during the R & D process, reducing the R & D difficulty, reducing the R & D cost, and saving the R & D time.

[0149] Under normal temperature, normal pressure, and without auxiliary reaction enzymes, gaseous oxygen or carbon dioxide usually does not react with drugs. Even carbon dioxide gas is regarded as an inert gas and is widely used in fields such as human laparoscopic surgery and food preservation.

[0150] Therefore, the only influencing factor for gas to become a drug carrier is the specific gravity of the drug. If the specific gravity is less than 3 g / cm 3Drugs with a density of (3000 Kg / cubic meter), theoretically, as long as the particles are small enough, in the micron range, can be suspended in the gas, regardless of the physical and chemical properties of the drug. The allowable specific gravity range of the drug can also be increased by means of ultrasonic waves, electric fields, magnetic fields, etc. Calculated according to the solid-gas mass ratio of 10 - 15 kg / kg for pneumatic conveying of 5-micron solid particles in industry, 600 ml of carbon dioxide gas is required to transport 10 g of glucose.

[0151] When applied to intravenous administration in the human body, it avoids the side effects of using liquid as the drug carrier. For example, for drugs that are insoluble in water, the allergic and toxic reactions of the organic solvents forced to be used, and the requirements for a specific pH value, etc.

[0152] The device for injecting drugs into the human vein provided by the present invention does not limit the total amount of the carrier, does not cause excessive input of the carrier, and enables pure drug intravenous injection. Especially for carbon dioxide gas, after being absorbed into the blood, the excess part beyond the physiological and pathological levels can be excreted from the lungs, realizing pure drug intravenous injection without a carrier, which is particularly suitable for patients with heart failure complicated with renal failure. Since carbon dioxide is a physiological product of the human body and the lungs can continuously excrete carbon dioxide, the input flow rate of carbon dioxide can be controlled without limiting the total amount of carbon dioxide input.

[0153] From the above embodiments, it can be seen that the purpose of the present invention is to provide a device and method for injecting drugs into the human vein. This device and method break through the technical prejudice and provide a way to inject drugs (including oxygen) into the human vein with a gas (under normal temperature and pressure conditions) as the carrier. By controlling the flow rate of the gas that can dissolve in the blood, the volume and quantity of the generated bubbles, it prevents the damage caused by gas embolism diseases, increases the contact area between the blood and the gas (especially oxygen), improves the effect of oxygen supply in the human vein, simplifies the production process of vascular oxygen supply, reduces the operation difficulty, and at the same time can use the gas as the carrier to inject drugs into the vein, and then use the blood as the carrier. For example, albumin in plasma can non-specifically bind lipophilic drugs (such as diazepam and warfarin) to form soluble complexes, and low-density lipoprotein (LDL) in plasma lipoprotein can carry cholesterol or lipophilic drugs (such as cyclosporine). The colloidal property of plasma: the colloidal system formed by proteins can stably suspend hydrophobic microparticles (such as liposome drugs), avoiding the damage caused by the solvents of these drugs that currently must use organic solvents, reducing the adjustment of the pH value in the solution state, the mutual reaction of drugs in the solution, reducing the increase in volume load caused by using liquid as the carrier. Later, after the gas completes its mission as the carrier, it is excreted from the body through the pulmonary circulation, realizing the input of pure drugs, and providing a new carrier for intravenous drug administration in the human body.

[0154] Specifically, when developing intravenous drugs for human use, there is no need to select and adjust the physical, chemical, and biological properties (except for specific gravity and the properties that can react with oxygen or carbon dioxide under normal temperature and pressure conditions) to ensure that the drug can be carried by a liquid. And this technical solution does not require the R & D process of selecting liquid types, adjusting the molecular polarity of the drug, encapsulating the drug molecules, etc. due to the solubility of the drug in the liquid, reducing the R & D difficulty, reducing the R & D cost, and saving the R & D time. Under normal temperature, normal pressure, and without auxiliary reaction enzymes, gaseous oxygen or carbon dioxide usually does not react with the drug. Even carbon dioxide gas is regarded as an inert gas and is widely used in fields such as human laparoscopic surgery and food preservation. Therefore, the only influencing factor for the gas to be the drug carrier is the specific gravity of the drug. If the specific gravity of the drug is less than 3 g / cm 3 For drugs, theoretically, as long as the particles are small enough, in the micron level, they can be suspended in the gas, regardless of the physical and chemical properties of the drug. The allowable specific gravity range of the drug can also be increased by means of ultrasonic waves, electric fields, and magnetic fields.

[0155] When applying intravenous drugs for human use, the side effects of using a liquid as the drug carrier are avoided. For example, for drugs that are insoluble in water, the allergic and toxic reactions of the organic solvents forced to be used, and the requirements for a specific pH value, etc.

[0156] There is no limit to the total amount of the carrier, no excessive input of the carrier, and pure drug intravenous infusion. For patients with heart failure complicated with renal failure, the restriction on liquids is extremely strict. As the liquid serving as the drug carrier, affected by factors such as the solubility, osmotic pressure, and pH value of the drug, a large amount of liquid serving as the carrier has to be input along with the drug, such as normal saline, which is 99% water and 0.9% sodium chloride, aggravating heart failure. And the excretion of these liquids requires the kidneys, and in the case of renal failure, the excretion is difficult, thus forming a vicious cycle. In this technical solution, oxygen or carbon dioxide gas, after being absorbed into the blood, the part exceeding the physiological and pathological levels can be excreted from the lungs, realizing pure drug intravenous infusion without a carrier, which is particularly suitable for patients with heart failure complicated with renal failure. Since carbon dioxide is a physiological product of the human body and the lungs can continuously excrete carbon dioxide, the input speed of carbon dioxide can be controlled and the total amount of carbon dioxide input is not restricted.

[0157] The above are only the preferred embodiments of the present application and are not used to limit the present application. For those skilled in the art, various changes and modifications can be made to the present application. Any modification, equivalent replacement, improvement, etc. made within the spirit and principle of the present application shall be included in the protection scope of the present application.

Claims

1. A device for injecting drugs into a human vein, characterized in that, It includes a gas source, a gas pipeline, a flow regulating valve, a flow detection device and a body insertion tip; The gas in the gas source is a gas that can combine with blood in a physical, chemical and / or biological form; the gas source is connected to the body insertion tip through the gas pipeline to input gas into the human vein, and form bubbles that are in direct contact with the blood without being wrapped by other substances in the blood; A flow regulating valve and a flow detection device are arranged on the gas pipeline.

2. The device for injecting drugs into a human vein according to claim 1, characterized in that, The outer wall of the body insertion tip has an annular protrusion and air outlet holes; The number of the annular protrusions is at least one, and at least one of the air outlet holes is arranged on both opposite sides of the annular protrusion.

3. The device for injecting drugs into a human vein according to claim 1, wherein The gas in the gas source is pure oxygen, carbon dioxide gas or a mixed gas of oxygen and carbon dioxide.

4. The device for injecting drugs into a human vein according to claim 1, characterized in that, It further includes a drug storage and release device and an injection pump; The injection pump sends the drug in the drug storage and release device into the gas pipeline, and enters the human vein along with the gas pipeline and the body insertion tip.

5. The device for injecting drugs into a human vein according to claim 1, characterized in that, It further includes: A blood oxygen detection device for detecting the blood oxygen saturation of the peripheral vein of the human body; An end-tidal carbon dioxide detection device for detecting the content of carbon dioxide exhaled by the human body; A B-ultrasound for monitoring the cardiac output, adjusting the flow rate of the gas input into the human vein in real time, and alarming when the monitored cardiac output is lower than the set value; The blood oxygen detection device or the end-tidal carbon dioxide detection device is signal-connected to the flow regulating valve, and alarms when it is higher than the set value.

6. The device for injecting a drug into a human vein according to claim 1, characterized in that, It further includes an ultrasonic device; The ultrasonic device is located inside or outside the gas pipeline or is part of the pipe wall, and can increase the number of bubbles generated by the gas in the gas pipeline and make the volume of a single bubble smaller; The ultrasonic device is used to maintain the dispersion state of the drug in the gas.

7. A method for injecting a drug into a human vein, characterized in that, Directly input a gas that combines with blood in a physical, chemical and / or biological form into the human vein to form bubbles; Control the gas flow rate entering the human vein through the flow regulating valve, thereby affecting the size and number of bubbles, and ensuring that the bubbles disappear before the right ventricle ejects blood.

8. The method for injecting a drug into a human vein according to claim 7, characterized in that, Use the gas in the bubbles as a carrier to carry the drug that can use blood as a carrier into the blood to form drug-containing bubbles.

9. The method for injecting a drug into a human vein according to claim 7 or 8, characterized in that, The way the flow regulating valve regulates the gas entering the human vein is a fluctuating regulation.

10. The method for injecting a drug into a human vein according to claim 7 or 8, characterized in that, Before the gas enters the blood to form bubbles, the gas flow direction is perpendicular to, obliquely backward or opposite to the blood flow direction.

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