Blood purification method, device and apparatus based on super-hydrophobic gas permeable membrane material

Abstract

The application discloses a blood purification method, device and apparatus based on a super-hemophobic and breathable membrane material. In the method, a suitable super-hemophobic and breathable membrane material is adopted, when blood flows through the super-hemophobic membrane, the temperature difference between the inside and outside of the membrane is controlled by using the breathability of the membrane, water in the blood carries metabolic molecules in the form of water vapor to pass through the holes on the membrane to the outside of the membrane, and is condensed and discharged outside the membrane. The method can realize the removal of excess water and metabolic substances in the blood without using dialysate. A blood purification device based on the super-hemophobic and breathable membrane and a portable blood purification apparatus are constructed according to the method. The application is an innovation of the blood purification method, and provides a train of thought for the development of a portable blood purification device.

Description

Technical Field

[0001] This invention relates to a blood purification method, device, and apparatus based on a superhydrophobic and breathable membrane material. Specifically, the method is based on a superhydrophobic and breathable membrane material and, by controlling the temperature difference between the inside and outside of the membrane, utilizes the principle of evaporation / condensation to remove excess metabolic molecules from the blood without the need for dialysate. It can be widely used in the treatment of various blood diseases. Background Technology

[0002] Kidney diseases, such as chronic kidney disease and end-stage renal disease, have high morbidity and mortality rates. These patients, due to impaired kidney function, retain excessive water and various metabolic molecules that cannot be excreted. For patients with kidney failure undergoing kidney transplantation, the most common clinical treatment is hemodialysis. This involves introducing the patient's blood and dialysate simultaneously into a dialyzer equipped with a hollow fiber membrane. Utilizing the solute and osmotic gradients across the porous membrane, excess water and metabolic molecules are removed through ultrafiltration, diffusion, and convection. Although hemodialysis effectively removes excess metabolic molecules from the blood, unlike natural kidneys which can continuously purify the blood, current clinical hemodialysis equipment is bulky and difficult to carry. Patients must undergo dialysis 3-4 times a week, which not only increases the risk of various cardiovascular diseases but also causes significant inconvenience to their daily lives.

[0003] To address these issues, researchers have developed various portable and wearable dialyzers and continuous renal replacement systems. Current technologies typically integrate porous membranes within microfluidic chips to remove biomolecules. While chip miniaturization facilitates portability and wearability, the design of these miniaturized microfluidic blood purification chips still relies on traditional hemodialysis principles. Blood purification requires a large amount of dialysate to maintain a sufficient concentration gradient across the dialysate membrane, and this high demand for dialysate hinders the clinical adoption of portable wearable blood purifiers. Current solutions involve introducing additional nanoporous adsorbents, adding a dialysate regeneration system, and connecting it in series with the hemodialysis machine. In existing technologies, ion-selective urease-fixed activated carbon fibers can selectively retain toxins. While this technology is structurally sound, simple in process, and portable, its adsorption efficiency per unit volume is low, requiring frequent column replacements, and it is difficult to control whether the regenerated dialysate meets reuse standards. Therefore, developing novel blood purification methods that can remove excess water and metabolic substances from patients' bodies without using dialysis fluid is a pressing issue in the field of portable blood purification. Summary of the Invention

[0004] In view of the above-mentioned deficiencies of the prior art, the objective of this invention is to develop a new generation of blood purification methods and construct a novel portable blood purification device, breaking through the current limitation that hemodialysis requires a large amount of dialysate, which is not conducive to portability and wearability. By utilizing superhydrophobic and breathable membrane materials, it is possible to remove excess metabolic molecules from the blood without using dialysate, providing technical support for the optimization of subsequent clinical blood purification methods and the development of novel portable blood purifiers.

[0005] This invention provides a blood purification method based on a superhydrophobic and breathable membrane material. This method eliminates the need for dialysate during blood purification, relying solely on the principle of evaporation / condensation. As blood flows through the superhydrophobic and breathable membrane, the temperature difference between the inside and outside of the membrane is controlled. Excess water molecules and metabolic molecules in the blood inside the membrane evaporate as water vapor and condense outside the membrane, thus achieving the removal of excess metabolic molecules from the blood. This method has a simple preparation process and is highly feasible. By simply preparing the superhydrophobic and breathable membrane material and controlling the temperature difference between the inside and outside of the membrane, the removal of excess water and metabolic molecules from the blood can be achieved. Blood purification devices constructed based on this method are expected to be portable and wearable.

[0006] To achieve the above objectives, the present invention adopts the following technical solution:

[0007] A blood purification method based on a superhydrophobic and breathable membrane material is characterized in that the purification method relies on the principle of evaporation / condensation. A temperature difference is set on both sides of the superhydrophobic and breathable membrane, with the temperature inside the membrane being higher than the temperature outside. Utilizing the breathability of the superhydrophobic and breathable membrane, when blood flows through it, the water in the liquid carries small molecules as water vapor through the pores in the membrane to the outside, where it condenses and is discharged.

[0008] Preferably, the small molecule substance is capable of evaporation, and its molecular weight Mn < 500D.

[0009] Preferably, the superhydrophobic and breathable membrane is an inorganic mesh or a high molecular weight organic membrane.

[0010] Preferably, the superhydrophobic and breathable membrane contains a porous network with a pore size of 0-3 mm.

[0011] Preferably, the superhydrophobic membrane is a superhydrophobic membrane surface modified with inert biomolecules.

[0012] Preferably, the small molecule substance includes at least one of water, urea, urea, creatinine, guanidines, amines, and phenols.

[0013] This application also relates to a purification device, the main body of which is a symmetrical 7-layer sandwich structure, consisting of glass, an outer liquid-conducting frame, a superhydrophobic and breathable membrane, an inner liquid circulation frame, a superhydrophobic and breathable membrane, an outer liquid-conducting frame, and glass.

[0014] This application also relates to a portable blood purification device, including a purification device, a peristaltic pump, and a heat preservation device connected in a closed loop via a circulation pipeline, and a cooling device is provided on both sides of the purification device.

[0015] Preferably, the heat preservation device controls the temperature of the circulating liquid to be maintained at 37°C, that is, the temperature inside the membrane is controlled at 37°C; the cooling device maintains the temperature outside the membrane below 37°C. Attached Figure Description

[0016] Figure 1 : Schematic diagram of the blood purification method according to the present invention

[0017] Figure 2 Schematic diagram of a blood purification device constructed according to the method described in this invention.

[0018] Figure 3 : A schematic diagram of the blood purification device frame constructed according to the method described in this invention, showing the outer fluid guiding frame (left) and the inner fluid circulation frame (right).

[0019] Figure 4 Schematic diagram of the portable blood purification device constructed according to the present invention.

[0020] Figure 5 Scanning electron microscope images of superhydrophobic and breathable membrane materials

[0021] Figure 6 3D-printed outer fluid guiding frame (left) and inner fluid circulation frame (right)

[0022] Figure 7 : Urea removal efficiency

[0023] Wherein: 1 is glass; 2 is the outer liquid guiding frame; 3 is the superhydrophobic and breathable membrane; 4 is the inner liquid circulation frame; 5 is the liquid inlet; 6 is the liquid outlet; and 7 is the condensate outlet. Detailed Implementation

[0024] The technical solution of the present invention will be further described in detail below with reference to specific embodiments. The following embodiments are merely illustrative and explanatory of the present invention and should not be construed as limiting the scope of protection of the present invention. All technologies implemented based on the above content of the present invention are covered within the scope of protection intended by the present invention.

[0025] Example:

[0026] A blood purification method based on a superhydrophobic and breathable membrane, the method relying on the principle of evaporation / condensation, setting a temperature difference across the membrane, utilizing the membrane's permeability, when blood flows through the breathable superhydrophobic membrane, the water in it, carrying metabolic molecules, permeates through the pores of the membrane in the form of water vapor to reach the outside of the membrane, where it condenses and is discharged. Figure 1 (As shown).

[0027] The blood purification method based on the superhydrophobic and breathable membrane described above can purify mainly evaporable small molecules with a molecular weight (Mn) < 500D. These include, but are not limited to, water, urea (a product of nucleoprotein and nucleic acid degradation), urea (a protein degradation product), creatinine (a phosphate metabolite in muscle), guanidines (metabolites of certain amino acids and creatine), amines (including aliphatic amines, aromatic amines, and polyamines), and phenols (metabolites of intestinal bacteria).

[0028] The blood purification method based on a superhydrophobic and breathable membrane includes, but is not limited to, the following types of superhydrophobic and breathable membranes: inorganic mesh membranes (stainless steel mesh, copper mesh, silicon-based mesh membrane, titanium-based mesh membrane, activated carbon mesh membrane, porous glass membrane), and polymeric organic membranes (cellulose and its derivative membranes, cuprammonium cellulose membranes, cellulose acetate membranes, nitrocellulose membranes, polymethyl methacrylate membranes, polyethersulfone membranes, polyamide membranes, polysulfone membranes, polyacrylonitrile membranes, polytetrafluoroethylene membranes, polycarbonate membranes, copper-form membranes, cuprammonium cellulose membranes, blood-form membranes, diacetate and triacetate membranes, polyacrylonitrile membranes, polymethyl methacrylate, polylactic acid membranes, collagen membranes, or chitosan membranes), etc.

[0029] The blood purification method based on a superhydrophobic and breathable membrane is described above, wherein the pore size of the porous network of the superhydrophobic and breathable membrane is 0-3 mm.

[0030] The blood purification method based on a superhydrophobic and breathable membrane, wherein the superhydrophobic membrane is a superhydrophobic membrane surface modified with inert biomolecules.

[0031] The superhydrophobic membrane described herein includes methods for preparing the superhydrophobic membrane such as electrospinning, electrospraying, chemical vapor deposition, electrochemical deposition, layer-by-layer deposition, phase separation, imprinting, sol-gel method, hydrothermal method, template method, and photolithography.

[0032] The superhydrophobic and breathable membrane described herein has a surface roughness of micro-nano, including micro-nano particles, nanofibers, nanorods, nanotubes, nanospheres, and nanoflowers.

[0033] The superhydrophobic and breathable membrane described herein contains surface-modified molecules including polyethylene glycol, peptides, amphoteric polymers, polysaccharides, etc.

[0034] The blood purification method based on superhydrophobic and breathable membrane utilizes the principle of evaporation / condensation. Specifically, it involves preparing a suitable superhydrophobic and breathable membrane material. When blood flows through the superhydrophobic membrane, the membrane's permeability is used to control the temperature difference between the inside and outside of the membrane. Water in the blood, carrying metabolic molecules, passes through the pores on the membrane in the form of water vapor and reaches the outside of the membrane, where it condenses and is discharged.

[0035] In conjunction with the blood purification method based on a superhydrophobic and breathable membrane described in this invention, a blood purification device based on a superhydrophobic and breathable membrane is provided, and a portable blood purification device is built based on this device.

[0036] The blood purification device based on the superhydrophobic and breathable membrane has a symmetrical 7-layer sandwich structure as its main body, consisting of glass, an outer fluid-conducting frame, a superhydrophobic and breathable membrane, an inner liquid circulation frame, another superhydrophobic and breathable membrane, an outer fluid-conducting frame, and glass. Figure 2 As shown.

[0037] like Figure 3 As shown, the outer liquid guiding frame includes a liquid guiding pipe and a liquid guiding frame, and the inner liquid circulation frame includes a liquid inlet, a liquid circulation frame, and a liquid outlet. The liquid inlet and liquid outlet are located on both sides of the liquid circulation frame, respectively.

[0038] The portable blood purification device described above includes, as its core components, a blood purification device based on a superhydrophobic and breathable membrane, a peristaltic pump, a heat preservation device, a condensation device, and a circulation pipeline. Figure 4 ).

[0039] The portable blood purification device includes a heat preservation device that controls the temperature of the circulating blood to remain at 37°C, i.e., the intramembrane temperature is controlled at 37°C; and a cooling device that maintains the extramembrane temperature below 37°C. Preferably, the temperature is below 20°C.

[0040] Evaluation of urea removal efficiency in urea stock solutions of different concentrations:

[0041] 1. Preparation of urea solution:

[0042] Weigh out 50 mg, 100 mg, 500 mg, 1 g, 2.5 g, and 5 g of urea respectively, dissolve them in 100 mL of PBS buffer solution to prepare urea solutions with concentrations of 0.5, 1, 5, 10, 25, and 50 mg / mL, and keep them in a 37°C water bath.

[0043] 2. Fabrication of a portable blood purification device based on a superhydrophobic and breathable membrane material:

[0044] A 300-mesh stainless steel mesh material was selected, and a roughened micro / nano structure was prepared on its surface using chemical vapor deposition. Then, by modifying the surface with low surface energy molecules, a breathable, superhydrophobic reticulum membrane material was prepared. The results are as follows: Figure 5 As shown. The outer frame of the device is designed using 3D printing. Figure 6 A blood purification device is fabricated by encapsulating a breathable superhydrophobic mesh and the device's outer frame together with waterproof silicone rubber.

[0045] 3. Evaluation of urea removal effect:

[0046] The urea solution kept at a constant temperature in step 1 is pumped into the blood purification device in step 2 using a peristaltic pump. After flowing through the superhydrophobic membrane, the liquid is pumped back into the thermos flask to participate in the circulation. Figure 4 When blood flows through a superhydrophobic membrane material, the membrane's permeability is utilized by adding a condenser to the outside of the blood purification device. This controls the temperature difference between the inside and outside of the membrane. Water in the blood, carrying metabolic molecules, passes through the pores in the membrane as water vapor and reaches the outside, where it condenses and is discharged. This process effectively removes excess water and urea. The results are as follows... Figure 7 As shown, urea solutions with concentrations of 0.5, 1, 5, 10, 25, and 50 mg / mL can all be removed using this method. Furthermore, compared to traditional hospital-based blood purification methods, this method eliminates the need for dialysis fluid, enabling portable and wearable solutions. The only required materials are a blood purification device based on a superhydrophobic and breathable membrane material, a peristaltic pump, a heat preservation device, a condensation device, and a circulation system. This demonstrates the superiority of the portable blood purification method based on a superhydrophobic and breathable membrane material presented in this invention.

Claims

1. A blood purification device, the main body of which is a symmetrical 7-layer sandwich structure, consisting of glass, an outer fluid-conducting frame, a superhydrophobic and breathable membrane, an inner fluid circulation frame, a superhydrophobic and breathable membrane, an outer fluid-conducting frame, and glass. The outer liquid guiding frame includes a liquid guiding pipe and a liquid guiding frame, as well as a condensate outlet. The inner liquid circulation frame includes a liquid inlet, a liquid circulation frame, and a liquid outlet, with the liquid inlet and liquid outlet located on both sides of the liquid circulation frame, respectively. The superhydrophobic and breathable membrane surface described therein has micro-nano roughness, including micro-nano particles, nanofibers, nanorods, nanotubes, nanospheres or nanoflowers; The superhydrophobic membrane described therein is a superhydrophobic membrane surface modified with inert biomolecules, including polyethylene glycol, peptides, amphoteric polymers or polysaccharides.

2. The blood purification device according to claim 1, wherein the superhydrophobic and breathable membrane is an inorganic mesh or a polymeric organic membrane, wherein the inorganic mesh includes stainless steel mesh, copper mesh, silicon-based mesh, titanium-based mesh, activated carbon mesh, and porous glass membrane, and the polymeric organic membrane includes cuprammonium cellulose membrane, cellulose acetate membrane, nitrocellulose membrane, polymethyl methacrylate membrane, polyethersulfone membrane, polyamide membrane, polysulfone membrane, polyacrylonitrile membrane, polytetrafluoroethylene membrane, polycarbonate membrane, copper-formaldehyde membrane, cuprammonium cellulose membrane, blood-formaldehyde membrane, diacetic acid membrane, triacetic acid membrane, polylactic acid membrane, collagen membrane, or chitosan membrane.

3. The blood purification device according to claim 1, wherein the superhydrophobic and breathable membrane is an inorganic mesh or a polymeric organic membrane, and the polymeric organic membrane includes cellulose and its derivative membranes.

4. The blood purification device according to claim 1, wherein the superhydrophobic and breathable membrane comprises a porous network, wherein the pore size of the porous network is 0-3 mm.

5. The method for preparing the blood purification device according to any one of claims 1-3, characterized in that, The method specifically includes: A 300-mesh stainless steel mesh material was selected, and a rough micro-nano structure was prepared on its surface using chemical vapor deposition. Then, by modifying the surface with low surface energy molecules, a breathable superhydrophobic mesh material was prepared. The outer frame of the device was designed using 3D printing, and the breathable superhydrophobic mesh and the outer frame of the device were encapsulated together with waterproof silicone rubber to prepare a blood purification device.

6. A portable blood purification device, comprising the blood purification device according to any one of claims 1-4, further comprising a peristaltic pump and a heat preservation device connected in a closed loop via a circulation pipeline, and a cooling device provided on both sides of the purification device.

7. The portable blood purification device according to claim 6, wherein the heat preservation device controls the temperature of the circulating liquid to be maintained at 37°C, that is, the temperature inside the superhydrophobic and breathable membrane is controlled at 37°C; and the cooling device maintains the temperature outside the superhydrophobic and breathable membrane below 37°C.

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