Bedside continuous bilirubin clearance system

Abstract

The application discloses a bedside continuous bilirubin removing system and relates to the technical field of bilirubin removing equipment, which comprises a blood circulation pipeline and an electric control module, the end of the blood circulation pipeline is used for being connected with a human body, the blood circulation pipeline comprises a photochemical section, the outer side of the photochemical section is provided with a photochemical module, the photochemical module comprises a photochemical light source, the photochemical light source can irradiate blood in the photochemical section, and the photochemical module is electrically connected with the electric control module. The blood in the human body can be guided out through the blood circulation pipeline, then the photochemical module is used for carrying out a photochemical reaction on the blood, the water solubility of bilirubin is improved, more bilirubin can be discharged along with a natural discharge path of the human body such as bile and urine, and therefore, the bedside continuous removal of bilirubin is realized.

Description

Technical Field

[0001] This invention relates to the field of bilirubin removal equipment technology, and in particular to a bedside continuous bilirubin removal system. Background Technology

[0002] Human red blood cells have a lifespan of approximately 120 days. Every day, a large number of red blood cells age and die, producing about 5g of waste hemoglobin per day. This waste hemoglobin is broken down into heme within macrophages of the reticuloendothelial system (spleen, liver Kupffer cells, bone marrow). Heme is then cleaved into biliverdin by heme oxygenase, and biliverdin is further reduced to unconjugated bilirubin (UCB, 250-300mg / day) by biliverdin reductase. Once in the bloodstream, UCB binds to albumin and is transported to the liver. In the smooth endoplasmic reticulum of hepatocytes, it binds to glucuronic acid via the UGT1A1 enzyme, generating water-soluble conjugated bilirubin (CB, 250-300mg / day). Conjugated bilirubin is taken up by bile capillaries and excreted into the bile duct system. In the colon, β-glucuronidase from bacteria debindes the urobilinogen to urobilinogen. UCB is then further reduced by the gut microbiota to urobilinogen. Urobilinogen can be further reduced to stercobilinogen or oxidized to stercobilin, giving the stool a yellow-brown color. A small portion of urobilinogen participates in the enterohepatic circulation and is eventually spontaneously oxidized to urobilin in the urine, giving the urine a yellow color.

[0003] The liver is the body's chemical factory, participating in the metabolism of many substances. The most clinically significant metabolic processes are the "detoxification metabolism" of bilirubin and the "synthetic metabolism" of clotting factors and albumin. Liver (functional) failure is often the common endpoint of various liver diseases or damage, manifesting as damage and dysfunction of hepatocytes and capillary bile cells. Damage and dysfunction of hepatocytes lead to metabolic disorders and accumulation of unconjugated bilirubin (UCB), while damage and dysfunction of capillary bile cells lead to impaired excretion and accumulation of conjugated bilirubin (CB), collectively resulting in hyperbilirubinemia (UCB+CB).

[0004] Hyperbilirubinemia is toxic to humans. UCB is lipid-soluble and cytotoxic. High concentrations of UCB can damage and cross the blood-brain barrier, interfering with mitochondrial metabolism, causing neurotoxicity and bilirubin encephalopathy; it can also exacerbate the toxicity and damage to hepatocytes; and cause metabolic and structural damage to organs or tissues such as the kidneys, heart, and red blood cells. While CB is water-soluble and often used as a marker of biliary system damage, there is limited clinical data on its toxicity in isolation.

[0005] Therefore, reducing excess bilirubin in the body is of great value in the treatment of liver failure. For diseases such as drug-induced hepatitis and primary biliary cholangitis (PBC, formerly known as primary biliary cirrhosis) with jaundice as the main clinical manifestation, treatment that simply promotes bilirubin metabolism and excretion can solve the main clinical problems. For diseases such as viral hepatitis with jaundice and coagulation dysfunction as the main clinical manifestations, treatment that promotes bilirubin metabolism and excretion can also solve an important part of the clinical problems.

[0006] Clinically, treatments to promote bilirubin metabolism and excretion mainly include medication, artificial liver therapy, and liver transplantation. Drug therapy, including S-adenosylmethionine and ursodeoxycholic acid, has the advantages of low cost and ease of use, but its efficacy is limited; many patients with liver failure cannot effectively clear sufficient bilirubin through drug therapy alone. Artificial liver therapy, also known as liver dialysis, includes resin-based bilirubin perfusion and plasma exchange. Plasma exchange can directly remove toxins such as bilirubin bound to albumin from the blood, while simultaneously replenishing clotting factors, showing definite efficacy. However, it often faces practical problems such as insufficient plasma supply and allergies. Various resin materials can selectively adsorb bilirubin from plasma, and the saturated adsorption column is then discarded to achieve bilirubin removal. However, the adsorption capacity of resin materials is limited; excessively increasing the surface area of ​​the adsorption material can lead to excessive loss of clotting factors such as platelets. Therefore, it needs to be administered intermittently every other day or at other frequencies, resulting in limited clinical efficacy. Its advantage is that it reduces bilirubin more effectively than drug treatment; its disadvantage is that the resin bilirubin adsorption column has an adsorption limit, each treatment lasts 2-3 hours, the total amount of bilirubin removed in a single treatment is limited, and it also adsorbs some clotting factors and other useful components in the blood, requiring repeated treatments and incurring high medical costs.

[0007] Various "bioartificial livers" can theoretically achieve continuous bilirubin clearance, but due to issues such as biocompatibility, safety, and stability, they are currently in the preclinical research stage and have not yet been widely used in clinical practice. Liver transplantation involves transplanting a healthy human liver into a patient with liver failure. Although the technology is relatively mature and the results are good, it has disadvantages such as donor shortages, the need for long-term oral anti-rejection drugs after transplantation, and the susceptibility to secondary infections, making it difficult to fully solve the problem of effective bilirubin clearance in the treatment of liver failure. While "xenotransplantation" can theoretically solve the problems of donors and even rejection, it is currently still in the preclinical experimental research stage for various reasons and has not yet been widely used in clinical practice.

[0008] In summary, the most effective treatment for severe hyperbilirubinemia in patients with liver failure is currently the non-biological artificial liver. However, the biggest drawback of non-biological artificial livers is their inability to achieve continuous bilirubin clearance.

[0009] The main reason why bilirubin cannot be continuously cleared at the bedside like creatinine is that bilirubin, especially unconjugated bilirubin, has extremely low water solubility and is difficult to dissolve in hemofiltration or hemodialysis fluid.

[0010] Therefore, there is an urgent need in the field for a bedside continuous bilirubin clearance system to solve the above problems. Summary of the Invention

[0011] The purpose of this invention is to provide a bedside continuous bilirubin removal system to solve the problems existing in the prior art, improve the water solubility of bilirubin, and achieve continuous removal of bilirubin.

[0012] To achieve the above objectives, the present invention provides the following solution: This invention discloses a bedside continuous bilirubin clearance system, comprising a blood circulation pipeline and an electrical control module. The end of the blood circulation pipeline is used to connect to the human body. The blood circulation pipeline includes a photochemical section, and a photochemical module is provided on the outside of the photochemical section. The photochemical module includes a photochemical light source, which can irradiate the blood in the photochemical section. The photochemical module is electrically connected to the electrical control module.

[0013] Preferably, the photochemical light source is a blue light source.

[0014] Preferably, the photochemical section is a two-dimensional planar pipeline or a three-dimensional solid pipeline.

[0015] Preferably, the photochemical module includes a photochemical housing, the photochemical light source is disposed inside the photochemical housing, and the photochemical housing is provided with a reflective layer.

[0016] Preferably, the blood circulation pipeline includes a temperature control section, and a temperature control module is provided on the outside of the temperature control section. The temperature control module includes a temperature detection device and a temperature control device. The temperature detection device is used to detect the blood temperature in the temperature control section, and the temperature control device is used to adjust the blood temperature in the temperature control section.

[0017] Preferably, the temperature control device includes a temperature control chamber filled with a temperature control medium, the temperature control section being located in the temperature control medium, and the temperature control chamber being connected to a temperature control device; The temperature control box is made of transparent material, and the temperature detection device is an infrared temperature sensor or a thermistor.

[0018] Preferably, the blood circulation pipeline is equipped with a blood sensor group.

[0019] Preferably, a plasma separator is connected to the blood circulation pipeline, the inlet of the plasma separator is connected to the inlet end of the blood circulation pipeline, the first outlet of the plasma separator is connected to the inlet end of the photochemical section, and the second outlet of the plasma separator is connected to the outlet end of the blood circulation pipeline. A heparin pump is connected to the pipeline between the inlet of the plasma separator and the inlet of the blood circulation pipeline; A blood end heater is provided on the pipeline between the second outlet of the plasma separator and the outlet end of the blood circulation pipeline.

[0020] Preferably, the blood circulation pipeline is equipped with an external blood processing device.

[0021] Preferably, the extracorporeal blood processing device is disposed within the photochemical module.

[0022] The present invention achieves the following technical effects compared to the prior art: This invention involves drawing the patient's blood out of the body via a central venous catheter (or a venous-arterial catheter). The blood is then irradiated with high-energy rays from a photochemical light source of specific wavelength and energy density, inducing bilirubin isomerization and increasing its water solubility. The increased water solubility of photoisomeric bilirubin allows it to be directly excreted through bile or urine, thereby reducing the concentration of bilirubin in the blood. Attached Figure Description

[0023] To more clearly illustrate the technical solutions in the embodiments of the present invention or the prior art, the drawings used in the embodiments will be briefly introduced below. Obviously, the drawings described below are only some embodiments of the present invention. For those skilled in the art, other drawings can be obtained based on these drawings without creative effort.

[0024] Figure 1 This is a schematic diagram of the bedside continuous bilirubin removal system in Example 1; Figure 2 This is a first structural diagram of the photochemical segment in the bedside continuous bilirubin removal system of Example 1; Figure 3 This is a second structural diagram of the photochemical segment in the bedside continuous bilirubin removal system of Example 1; Figure 4 This is a third structural diagram of the photochemical segment in the bedside continuous bilirubin removal system of Example 1; Figure 5 This is a fourth structural diagram of the photochemical segment in the bedside continuous bilirubin removal system of Example 1; Figure 6 This is a schematic diagram of the bedside continuous bilirubin removal system in Example 2; Figure 7 This is a schematic diagram of the bedside continuous bilirubin removal system in Example 3; Figure 8 This is a schematic diagram of the bedside continuous bilirubin removal system in Example 4; Figure 9 This is a schematic diagram of the extracorporeal blood processing device in the bedside continuous bilirubin removal system of Example 4; Figure 10 This is an internal cross-sectional view of the first photochemical shell in the bedside continuous bilirubin removal system of Example 4; Figure 11 This is an internal cross-sectional view of the second type of photochemical shell in the bedside continuous bilirubin removal system of Example 4; Figure 12 This is an internal cross-sectional view of the third type of photochemical shell in the bedside continuous bilirubin removal system of Example 4; In the diagram: 1-Blood circulation tubing; 2-Photochemical module; 3-Temperature control module; 4-Blood circulation pump; 5-Photochemical section; 6-Plasma separator; 7-Blood end heater; 8-Heparin pump; 9-Extracorporeal blood processing device; 10-Semi-permeable membrane fiber tube; 11-Photochemical outer shell; 12-Photochemical light source. Detailed Implementation

[0025] The technical solutions of the embodiments of the present invention will be clearly and completely described below with reference to the accompanying drawings. Obviously, the described embodiments are only some embodiments of the present invention, and not all embodiments. Based on the embodiments of the present invention, all other embodiments obtained by those skilled in the art without creative effort are within the scope of protection of the present invention.

[0026] The purpose of this invention is to provide a bedside continuous bilirubin removal system to solve the problems existing in the prior art, improve the water solubility of bilirubin, and achieve continuous removal of bilirubin.

[0027] To make the above-mentioned objects, features and advantages of the present invention more apparent and understandable, the present invention will be further described in detail below with reference to the accompanying drawings and specific embodiments.

[0028] Example 1 like Figures 1-5As shown, this embodiment provides a bedside continuous bilirubin removal system, including a blood circulation tubing 1 and an electronic control module. The end of the blood circulation tubing 1 is connected to the human body, specifically to a central venous or arterial catheter. This is a conventional connection method for existing dialysis or hemofiltration, and therefore will not be elaborated further. A blood circulation pump 4 is installed on the blood circulation tubing 1 to provide power for blood flow. The blood circulation pump 4 can be a common peristaltic pump. It should be noted that the blood circulation tubing 1 includes a photochemical section 5, which can be a part of the blood circulation tubing 1 or an additional section connected to it. A photochemical module 2 is located on the outside of the photochemical section 5, including a photochemical light source 12. The photochemical light source 12 can irradiate the blood in the photochemical section 5. Both the photochemical module 2 and the blood circulation pump 4 can be electrically connected to the electronic control module, which includes, but is not limited to, an existing microcontroller (MCU) controller. The electronic control module can control the operation of the photochemical module 2 and the blood circulation pump 4.

[0029] In practical use, under the pumping power of the blood circulation tubing 1 and the blood circulation pump 4, human blood is drawn through a central venous or arterial catheter, then passes through the photochemical module 2, and under the irradiation of the photochemical light source 12, unconjugated bilirubin (4Z, 15Z) undergoes photoisomerization into the configurational isomerized 4Z / 15E and the configurational isomerized seven-membered ring product lumirubin, thereby increasing its water solubility. The photochemically treated blood then re-enters the human body through the blood circulation tubing 1 and is ultimately excreted along with urine.

[0030] In this embodiment, the photoluminescent light source 12 is a blue light source, specifically a blue LED bead. Of course, those skilled in the art can also replace it with a light source such as an OLED. The blue light source is used to emit blue light of a specific wavelength of 470nm. Of course, those skilled in the art can also use light capable of emitting other wavelengths or X-rays, as long as it can promote the isomerization of bilirubin or other endogenous or exogenous toxins in the human body or cause beneficial chemical reactions.

[0031] The mechanism by which the water solubility of unconjugated bilirubin (UCB) increases under blue light irradiation is a photochemical reaction, mainly including the following two types of processes: (1) Main mechanism: Photoisomerization. Under physiological conditions, unconjugated bilirubin is in the Z,Z-configuration (i.e., the two acrylic acid side chains are in the cis configuration), which is highly lipid-soluble, insoluble in water, and cannot be directly excreted by the kidneys or bile. It is transported to the liver by binding to plasma albumin, and only becomes water-soluble after binding to glucuronic acid in hepatocytes. After absorbing blue light (blue light wavelength 450-490nm), the bilirubin molecule undergoes a configurational change: Z → E isomerization: one or two acrylic acid side chains change from cis (Z) to trans (E), forming 4Z,15E-bilirubin or 4E,15E-bilirubin. These E-isomers have higher polarity and water solubility, and can be directly excreted (through bile and urine) without liver metabolism. (2) Secondary mechanism: Photooxidation. Under continuous light exposure, some bilirubin can be oxidized to form water-soluble dipyrrole products (such as propentdyopents). These products are colorless and non-toxic and can be rapidly excreted through the kidneys. This process is relatively slow and usually plays an auxiliary role in long-term light exposure.

[0032] In this embodiment, the photochemical segment 5 is a two-dimensional planar conduit or a three-dimensional conduit. A two-dimensional planar conduit is a conduit structure designed to extend along a plane, while a three-dimensional conduit is a conduit structure designed to extend along space. See the figure below for details: Figure 2 This is the first type of two-dimensional planar pipeline, whose main body is distributed in an S-shape or serpentine pattern.

[0033] Figure 3 This is the second type of two-dimensional planar conduit, in which blood enters and is divided into multiple parallel channels, and then converges at the outlet of the two-dimensional planar conduit.

[0034] Figure 4 As the third type of two-dimensional planar pipeline, the entire photochemical section 5 is spirally distributed with the inlet and outlet set in parallel.

[0035] Figure 5 The first type of three-dimensional pipeline, as can be seen from the figure, has a spiral distribution in this photochemical section 5.

[0036] Figures 2-5The arrows inside the photochemical section 5 indicate the direction of blood flow, while the arrows outside the photochemical section 5 indicate the direction of blue light irradiation. Since the blood circulation tubing 1 is a common medical transparent tube (such as a PVC or silicone tube), the blue light can pass through the photochemical section 5 and irradiate the blood inside. Whether it's a two-dimensional planar tubing or a three-dimensional tubing, it's not limited to the examples mentioned above; those skilled in the art can design two-dimensional planar tubing and three-dimensional tubing into other shapes according to actual needs.

[0037] In this embodiment, the photochemical module 2 includes a photochemical housing 11, and a photochemical light source 12 is disposed inside the photochemical housing 11. A reflective layer is provided on the inner wall of the photochemical housing 11, the function of which is to reflect the blue light to be emitted back onto the photochemical section 5, thereby improving the efficiency of light absorption and light reaction, and preventing blue light leakage and environmental pollution. The reflective layer can be a common reflector or a metal plate with reflective capabilities (including but not limited to an aluminum plate).

[0038] In this embodiment, the blood circulation pipeline 1 includes a temperature control section, which is part of the blood circulation pipeline 1. A temperature control module 3 is provided on the outer side of the temperature control section. The temperature control module 3 includes a temperature detection device and a temperature control device. The temperature detection device is used to detect the blood temperature within the temperature control section, and the temperature control device is used to adjust the blood temperature within the temperature control section. Both the temperature detection device and the temperature control device can be electrically connected to the electronic control module. In actual use, the temperature detection device monitors the blood temperature within the temperature control section in real time. If the blood temperature is too high or too low, the temperature control device can be activated to adjust the blood temperature, so that the blood re-flowing into the human body matches the original blood temperature in the human body.

[0039] In this embodiment, the temperature control device includes a temperature control chamber filled with a temperature control medium, which can be water. A temperature control section is located within the temperature control medium. The temperature control chamber is connected to a temperature control device, which controls the water temperature, thereby controlling the blood temperature within the temperature control section.

[0040] Temperature control equipment can employ common heating devices such as thermoelectric coolers and heating rods. When using a thermoelectric cooler, the heating end of the cooler must be attached to the outer wall of the temperature control chamber. When activated, the cooler heats the chamber and the water inside. If a heating rod is used, its heating element is simply inserted directly into the water within the chamber. Alternatively, those skilled in the art can install an outlet and inlet pipe on the side wall of the temperature control chamber. The ends of these pipes, furthest from the chamber, connect to the inlet and outlet of a circulating water bath. Water pumps can also be installed on the inlet and outlet pipes. During operation, water from the temperature control chamber flows through the outlet pipe into the circulating water bath, where it is heated. The heated water then flows back into the temperature control chamber through the inlet pipe. Since the ambient temperature is generally lower than the body temperature after blood flows out of the body, it usually needs to be heated. However, if it is necessary to cool the blood in the temperature control section, a fan can be installed on one side of the temperature control box to use air cooling to cool it down.

[0041] The temperature control chamber is made of transparent material, including but not limited to glass. The temperature detection device is an infrared temperature sensor, which can remotely detect the water temperature inside the chamber and feed it back to the electronic control module. The electronic control module then controls the temperature control device, thus forming a closed-loop control. Alternatively, a thermistor can be used to directly detect the internal temperature of the temperature control chamber.

[0042] In this embodiment, a blood sensor group is installed on the blood circulation pipeline 1. The blood sensor group is electrically connected to the electronic control module, facilitating real-time monitoring of the blood condition within the blood circulation pipeline 1 by the electronic control module. The blood sensor group includes, but is not limited to, a pressure sensor and a bubble sensor. The pressure sensor monitors the blood pressure in the blood circulation pipeline 1 and feeds it back to the electronic control module. The electronic control module adjusts the operating rate of the blood circulation pump 4 based on the blood pressure; that is, if the blood pressure is too high, the rotation of the blood circulation pump 4 is reduced; conversely, if the blood pressure is too low, the rotation of the blood circulation pump 4 is increased. The bubble sensor monitors air bubbles in the blood and sends an alarm to the electronic control module if a problem occurs.

[0043] Example 2 like Figure 6 As shown, this embodiment provides a bedside continuous bilirubin clearance system. This embodiment includes all the technical features disclosed in Embodiment 1, with the difference being: In this embodiment, a plasma separator 6 is connected to the blood circulation pipeline 1. The inlet of the plasma separator 6 is connected to the inlet of the blood circulation pipeline 1, the first outlet of the plasma separator 6 is connected to the inlet of the photochemical section 5, and the second outlet of the plasma separator 6 is connected to the outlet of the blood circulation pipeline 1. In actual use, fresh blood entering the blood circulation pipeline 1 first enters the plasma separator 6 for separation. The plasma flowing out of the first outlet of the plasma separator 6 enters the photochemical module 2 for photochemical reaction, then enters the temperature control module to adjust its temperature, and then merges with the plasma flowing out of the second outlet of the plasma separator 6 before finally flowing into the human body. The plasma separator 6 is provided to separate white blood cells, red blood cells, and some biomolecules in the blood, preventing blue light irradiation from affecting their activity.

[0044] A heparin pump 8 is connected to the pipeline between the inlet of the plasma separator 6 and the inlet of the blood circulation pipeline 1. Anticoagulant drugs (including but not limited to heparin) can be injected into the blood circulation pipeline 1 through the heparin pump 8, thereby preventing clotting problems in the blood circulation pipeline 1.

[0045] A blood end heater 7 is installed on the pipeline between the second outlet of the plasma separator 6 and the outlet of the blood circulation pipeline 1. The blood end heater 7 can be a common electric heater, heating resistance wire, or semiconductor cooling chip. The reason for setting up the blood end heater 7 is that the temperature of the plasma flowing out of the second outlet of the plasma separator 6 is lower than the temperature of blood in the human body, so it needs to be heated to raise its temperature. Of course, those skilled in the art can also set up only one blood end heater 7 without setting up a temperature control module, depending on the actual situation.

[0046] In this embodiment, the blood sensor group also includes a blood leakage sensor, i.e., a multi-wavelength optical sensor, used to measure hemoglobin (Hb) and hematocrit (Hct, which indirectly reflects the number of red blood cells), collectively referred to in the industry as an online blood optical monitoring sensor. The probe of the blood leakage sensor is located behind the first outlet of the plasma separator 6, used to monitor the hemoglobin content flowing out of the first outlet of the plasma separator 6. If the content is too high, it indicates that the plasma separator 6 has failed and should be replaced in time.

[0047] In this embodiment, if it is necessary to avoid other types of molecules from being affected by blue light, a secondary blood component separator with a smaller filtration pore size can be added after the plasma separator 6. This secondary blood component separator can be used to separate small molecules such as bilirubin and water from medium and large molecular active substances such as albumin, immunoglobulins, thrombin, and certain hormones, and then perform photochemical filtration and removal. The design of the secondary blood component separator is the same as that of the aforementioned plasma separator, but the specific filtration pore size of the membrane material is selected according to clinical needs.

[0048] Example 3 like Figure 7 As shown, this embodiment provides a bedside continuous bilirubin clearance system. This embodiment includes all the technical features disclosed in Embodiment 2, with the difference being: In this embodiment, an extracorporeal blood processing device 9 is provided on the blood circulation pipeline 1, and the extracorporeal blood processing device 9 is located between the photochemical module 2 and the temperature control module 3. The extracorporeal blood processing device 9 can be an existing blood filter or blood permeator. Figure 7 The extracorporeal blood treatment device 9 is a hemodialyzer, with its upper tube for introducing dialysate and its lower tube for discharging waste fluid. If the extracorporeal blood treatment device 9 is a blood filter, a replacement fluid inlet tube needs to be connected to the inlet of the extracorporeal blood treatment device 9. In actual use, when photochemically treated plasma is introduced into the extracorporeal blood treatment device 9, the device can remove some of the photochemically treated bilirubin and other target toxin molecules from the blood. Furthermore, by adjusting the inflow rate of the blood filtrate or dialysate, the removal efficiency of photochemically treated bilirubin and other target substances can be adjusted without affecting the excretion of these photochemical products in the body via the liver and kidneys.

[0049] Example 4 like Figure 8 As shown, this embodiment provides a bedside continuous bilirubin removal system. The technical features provided in this embodiment are basically the same as those disclosed in Embodiment 3, except that the location of the extracorporeal blood processing device 9 is different.

[0050] In this embodiment, the extracorporeal blood processing device 9 is disposed within the photochemical module 2, and the photochemical section 5 is the extracorporeal blood processing device 9 and not a tubular structure. Therefore, this embodiment actually provides an integrated "photochemical-hemofiltration / dialysis" filter, namely a bilirubin photochemical-scavenger, which can both achieve photochemical changes in bilirubin and remove some of the photochemically processed bilirubin.

[0051] like Figure 9 As shown, the photochemical shell 11 contains multiple semi-permeable membrane fiber tubes 10 with a molecular weight cutoff of 500 Daltons. The semi-permeable membrane fiber tubes 10 allow small molecules such as water-soluble bilirubin, creatinine, blood potassium, and water to move between the inner and outer surfaces of the semi-permeable membrane fiber tubes 10, but do not allow large biological molecules such as albumin and thrombin to move between the inner and outer surfaces of the semi-permeable membrane fiber tubes 10. Figure 9The mid-section area represents the plasma flow region, while the blank area represents the dialysate flow region. The upper fitting of the photosensitive outer shell 11 is used for dialysate inlet, the lower fitting for waste liquid outlet, the right fitting for plasma inlet, and the left fitting for plasma outlet, ensuring that the dialysate and plasma flow in opposite directions. In actual use, through diffusion, some of the photosensitive bilirubin in the plasma passes through the semipermeable membrane fiber tube 10 into the dialysate and is discharged along with it.

[0052] It is particularly important to note that this embodiment differs from traditional hemodialysis machines in that, in traditional hemodialysis machines, plasma is introduced into the semi-permeable membrane fiber tubes 10, and dialysate flows through the gaps between the semi-permeable membrane fiber tubes 10. In this embodiment, however, dialysate is introduced into the semi-permeable membrane fiber tubes 10, and plasma flows through the gaps between the semi-permeable membrane fiber tubes 10. The advantage of this arrangement is that it improves the efficiency of blue light irradiation of the plasma.

[0053] like Figures 10-12 As shown, this embodiment provides internal cross-sectional views of three types of photochemical shells 11.

[0054] like Figure 10 As shown, the photochemical outer shell 11 has a cylindrical structure, and the extracorporeal blood processing device 9 inside it also has a cylindrical structure. Multiple photochemical light sources 12 are evenly distributed around the outer wall of the photochemical outer shell 11 and the extracorporeal blood processing device 9. Multiple semi-permeable membrane fiber tubes 10 are provided inside the extracorporeal blood processing device 9.

[0055] like Figure 11 As shown, the photochemical outer shell 11 has a cylindrical structure, and the extracorporeal blood processing device 9 inside it has a circular structure. Multiple photochemical light sources 12 are evenly distributed around the circumference between the photochemical outer shell 11 and the outer wall of the extracorporeal blood processing device 9. Multiple semi-permeable membrane fiber tubes 10 are evenly distributed around the circumference inside the extracorporeal blood processing device 9. Multiple photochemical light sources 12 are also evenly distributed around the circumference on the inner side of the extracorporeal blood processing device 9. Blue light is provided to the plasma through the photochemical light sources 12 on both the inner and outer sides.

[0056] like Figure 12 As shown, the photochemical shell 11 has a rectangular structure, and the extracorporeal blood processing device 9 inside it also has a rectangular structure. Multiple photochemical light sources 12 are evenly distributed between the outer wall of the photochemical shell 11 and the outer wall of the extracorporeal blood processing device 9. Multiple semi-permeable membrane fiber tubes 10 are provided inside the extracorporeal blood processing device 9.

[0057] In this embodiment, the blood sensor assembly also includes a bilirubin detector, the probe of which is disposed in the waste liquid discharge pipeline (i.e., Figure 9 The lower end of the tube is used to monitor the bilirubin content in the waste liquid.

[0058] In the description of this invention, it should be understood that the terms "longitudinal," "lateral," "upper," "lower," "front," "rear," "left," "right," "vertical," "horizontal," "top," "bottom," "inner," and "outer," etc., indicate the orientation or positional relationship based on the orientation or positional relationship shown in the accompanying drawings, and are only for the convenience of describing this invention, and do not indicate or imply that the device or element referred to must have a specific orientation, or be constructed and operated in a specific orientation, and therefore should not be construed as a limitation of this invention. Furthermore, the terms "first," "second," "third," etc., are used for descriptive purposes only and should not be construed as indicating or implying relative importance. Thus, a feature defined with "first," "second," etc., may explicitly or implicitly include one or more of that feature. In the description of this invention, unless otherwise stated, "a plurality of" means two or more.

[0059] In the description of this invention, unless otherwise expressly specified and limited, the terms "installation," "connection," and "linking" should be interpreted broadly. For example, they can refer to fixed connections, detachable connections, or integral connections; they can refer to mechanical connections or electrical connections; they can refer to direct connections or indirect connections through an intermediate medium; and they can refer to the internal communication between two components. Those skilled in the art can understand the specific meaning of the above terms in this application based on the specific circumstances.

[0060] If this invention discloses or relates to components or structural parts that are fixedly connected to each other, then, unless otherwise stated, a fixed connection can be understood as: a detachable fixed connection (e.g., using bolts or screws) or a non-detachable fixed connection (e.g., riveting, welding). Of course, a fixed connection can also be replaced by an integral structure (e.g., manufactured in one piece using a casting process) (except where it is obviously impossible to use an integral molding process).

[0061] In addition, unless otherwise stated, the terms used in any of the technical solutions disclosed in this invention to indicate positional relationships or shapes include states or shapes that are similar to, close to, or approximate with those states or shapes.

[0062] Any component provided by this invention can be assembled from multiple individual components or can be a single component manufactured by a one-piece molding process.

[0063] It should be noted that the structures, proportions, sizes, etc., depicted in the accompanying drawings of this specification are only for the purpose of assisting those skilled in the art in understanding and reading the content disclosed in the specification, and are not intended to limit the conditions under which the present invention can be implemented. Therefore, they have no substantial technical significance. Any modifications to the structure, changes in the proportions, or adjustments to the size, without affecting the effects and objectives that the present invention can produce, should still fall within the scope of the technical content disclosed in the present invention.

[0064] It should also be noted that in the embodiments of this application, the same reference numerals are used to denote the same component or the same part.

[0065] Any adaptive changes made according to actual needs are within the scope of protection of this invention.

[0066] Specific examples have been used to illustrate the principles and implementation methods of this invention. The descriptions of the above embodiments are only for the purpose of helping to understand the method and core ideas of this invention. Furthermore, those skilled in the art will recognize that, based on the ideas of this invention, there will be changes in the specific implementation methods and application scope. Therefore, the content of this specification should not be construed as a limitation of this invention.

Claims

1. A bedside continuous bilirubin clearance system, characterized in that: The device includes a blood circulation pipeline and an electronic control module. The end of the blood circulation pipeline is used to connect to the human body. The blood circulation pipeline includes a photochemical section. A photochemical module is provided on the outside of the photochemical section. The photochemical module includes a photochemical light source. The photochemical light source can irradiate the blood in the photochemical section. The photochemical module is electrically connected to the electronic control module.

2. The bedside continuous bilirubin clearance system according to claim 1, characterized in that: The photochemical light source is a blue light source.

3. The bedside continuous bilirubin clearance system according to claim 1, characterized in that: The photochemical section is a two-dimensional planar pipeline or a three-dimensional solid pipeline.

4. The bedside continuous bilirubin clearance system according to claim 1, characterized in that: The photochemical module includes a photochemical housing, the photochemical light source is disposed inside the photochemical housing, and the photochemical housing is provided with a reflective layer.

5. The bedside continuous bilirubin clearance system according to claim 1, characterized in that: The blood circulation pipeline includes a temperature control section, and a temperature control module is provided on the outside of the temperature control section. The temperature control module includes a temperature detection device and a temperature control device. The temperature detection device is used to detect the blood temperature in the temperature control section, and the temperature control device is used to adjust the blood temperature in the temperature control section.

6. The bedside continuous bilirubin clearance system according to claim 5, characterized in that: The temperature control device includes a temperature control chamber filled with a temperature control medium, a temperature control section located in the temperature control medium, and a temperature control device connected to the temperature control chamber. The temperature control box is made of transparent material, and the temperature detection device is an infrared temperature sensor or a thermistor.

7. The bedside continuous bilirubin clearance system according to claim 1, characterized in that: The blood circulation pipeline is equipped with a blood sensor array.

8. The bedside continuous bilirubin clearance system according to claim 1, characterized in that: A plasma separator is connected to the blood circulation pipeline. The inlet of the plasma separator is connected to the inlet of the blood circulation pipeline. The first outlet of the plasma separator is connected to the inlet of the photochemical section. The second outlet of the plasma separator is connected to the outlet of the blood circulation pipeline. A heparin pump is connected to the pipeline between the inlet of the plasma separator and the inlet of the blood circulation pipeline; A blood end heater is provided on the pipeline between the second outlet of the plasma separator and the outlet end of the blood circulation pipeline.

9. The bedside continuous bilirubin removal system according to claim 8, characterized in that: An external blood processing device is installed on the blood circulation pipeline.

10. The bedside continuous bilirubin clearance system according to claim 9, characterized in that: The extracorporeal blood processing device is located within the photochemical module.

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