In-vitro plasma biological purification device

Abstract

The utility model provides an in-vitro plasma biological purification device, which belongs to the technical field of biomedical equipment and comprises a purification column shell, a plasma inlet positioned at the lower end of the purification column shell, a plasma outlet positioned at the upper end of the purification column shell, and a PET (Polyethylene Terephthalate) non-woven fabric microcarrier and a plurality of PES (Polyether Sulfonate) single-channel hollow fibers which are positioned in the purification column shell and are sequentially distributed from bottom to top. The columnar plasma biological purification device is characterized in that a plurality of PES (polyethersulfone) hollow fibers are arranged in the center of a columnar container and are uniformly arranged in parallel up and down, and a microcarrier on which cells grow can be arranged on the periphery of the PES hollow fibers, so that the biological purification effect on plasma is realized. All the PES hollow fibers are converged at the upper end of the plasma purification column, and the surface of each PES hollow fiber has a very small aperture. Plasma enters the purification column from the side of the bottom of the purification column, enters the PES hollow fiber after being biologically purified by the microcarrier overgrown with cells, then flows out from the upper end of the purification column and is input back to a human body, and the PES hollow fiber tube can prevent pollutants such as cell debris, bacteria and microcarrier impurities from entering the human body in the whole process.

Description

Technical Field

[0001] The utility model belongs to the technical field of biomedical equipment, and particularly relates to an in vitro plasma biological purification device. Background Art

[0002] With the progress of biotechnology and materials science, the therapeutic potential of in vitro artificial organs has been widely explored and recognized. In this context, bioartificial liver (BAL), as a device for replacing liver function in vitro, is an important treatment strategy for organ support in patients with liver failure and has become the focus of clinical research. The bioartificial liver system usually operates by simulating the metabolic, synthetic, and detoxification functions of the natural liver, and these functions rely on efficient plasma purification technology and biocompatible cell microcarriers.

[0003] In the prior art, the cell microcarriers used are usually made of polymer non-woven materials, such as PET (polyethylene terephthalate), which provides a three-dimensional structure to support the growth of hepatocytes. However, these cell-laden microcarriers have a major problem during long-term blood contact and dynamic biological purification, namely fiber shedding. These shed fibers may cause diseases, such as vascular embolism, increasing the risk for patients receiving bioartificial liver treatment. In addition, as the plasma passes through the cell carrier, the cells themselves and their debris may also shed into the bloodstream, increasing the possibility of immune response and inflammation. Despite the filtration and purification steps, the prior art fails to provide a cell carrier that can ensure both efficient plasma fluidity and prevent cell and fiber shedding.

[0004] Therefore, there is an urgent need to provide a new type of plasma purification device, aiming to solve the problems of fiber shedding and cell debris, while maintaining or improving plasma purification efficiency. Summary of the Utility Model

[0005] The utility model is to solve the above technical problems, and thus provides an in vitro plasma biological purification device. The purification device needs to have optimized hydrodynamic characteristics and adopt more advanced materials to solve the problems of fiber shedding and cell debris generated by the existing cell culture microcarriers, thereby significantly improving the safety and effectiveness of the bioartificial liver system.

[0006] To solve the above technical problems, the utility model adopts the following technical solutions to achieve:

[0007] An in-vitro plasma biological purification device, comprising a purification column housing, a plasma inlet at the lower end of the purification column housing and a plasma outlet at the upper end, and a PET non-woven fabric microcarrier and multiple PES single-channel hollow fiber filaments sequentially distributed from bottom to top inside the purification column housing; wherein, the multiple PES single-channel hollow fiber filaments are uniformly and parallelly arranged along the up-and-down direction inside the purification column, and the multiple PES single-channel hollow fiber filaments all converge at the upper end of the purification column and are connected to the plasma outlet; the PET non-woven fabric carrier is located between the multiple PES single-channel hollow fiber filaments and at the lower part of the purification column.

[0008] The utility model provides a columnar plasma biological purification device, which is characterized in that the interior is designed to place multiple polyethersulfone resin (PES) hollow fiber filaments in parallel and vertically arranged uniformly at the center of a columnar container, and a microcarrier with cells growing thereon can be placed on the outer periphery of the PES hollow fiber filaments to achieve the biological purification effect on plasma. All the PES hollow fiber filaments converge at the upper end of the plasma purification column, and there are extremely small pore diameters on the surfaces of the PES hollow fiber filaments. Plasma enters the purification column from the side at the bottom of the purification column, completes biological purification through the microcarrier covered with cells, then enters the PES hollow filaments and flows out from the upper end of the purification column, and is reinfused into the human body. Pollutants such as cell debris, bacteria, and impurities can be prevented from entering the human body during the whole process.

[0009] Furthermore, the pore diameter of the multiple PES single-channel hollow fiber filaments is 0.02 μm. By using the hollow fiber filaments with this pore diameter, the above effects can be well achieved.

[0010] Furthermore, the number of the PES single-channel hollow fiber filaments is 500 - 3000. It should be noted that in the utility model, it is not only limited to the above range. The actual number of the hollow fiber filaments is not limited, as long as the above effects of the utility model can be achieved.

[0011] Furthermore, the multiple PES single-channel hollow fiber filaments are prepared into hollow fiber filaments by electrospinning multiple polyethersulfone resins.

[0012] Furthermore, the device further comprises a pressure detection device arranged above the purification column housing for detecting the pressure inside the purification column. A pressure detection port is provided on the side of the upper part of the purification column for monitoring the pressure inside the purification column and maintaining the pressure for the cells to normally perform the purification function.

[0013] The beneficial effects of the utility model are as follows:

[0014] The present utility model provides a bioartificial liver biofiltration column structure with a brand-new design. Through the precisely designed PES hollow fiber filaments, PET cell microcarriers, and an optimized columnar structure, it solves the problems in traditional technologies, such as the easy shedding of fiber from cell microcarriers and the easy generation of cell debris during cell culture, which affect the quality of plasma and pose a disease risk. Through the present utility model, it is expected to improve the safety and effectiveness of bioartificial liver treatment and open up new possibilities for clinical applications. BRIEF DESCRIPTION OF THE DRAWINGS

[0015] Figure 1 is a schematic structural diagram of the plasma biofiltration device of the present utility model;

[0016] Figure 2 is a schematic diagram of the working principle of the present utility model. DETAILED DESCRIPTION OF THE EMBODIMENTS

[0017] In order to make the objectives, technical solutions and advantages of the present utility model more clear and understandable, the present utility model will be specifically described below in conjunction with embodiments and the accompanying drawings. It is necessary to point out that the following embodiments are only used to explain and illustrate the present utility model and are not used to limit the present utility model. Some non-essential improvements and adjustments made by those skilled in the art based on the above content still fall within the protection scope of the present utility model.

[0018] Embodiment 1

[0019] As Figure 1 shown, the present utility model provides a plasma biofiltration device, including a filtration column housing 1, a plasma inlet 2 at the lower end of the filtration column housing and a plasma outlet 3 at the upper end, and a PET non-woven fabric microcarrier 4 and multiple PES single-channel hollow fiber filaments 5 distributed in sequence from bottom to top inside the filtration column housing; wherein, the multiple PES single-channel hollow fiber filaments 5 are uniformly and parallelly arranged along the up-and-down direction inside the filtration column, and the multiple PES single-channel hollow fiber filaments all converge at the upper end of the filtration column and are connected to the plasma outlet 3; the PET non-woven fabric microcarrier 4 is located between the multiple PES single-channel hollow fiber filaments 5 and at the lower part of the filtration column. The pore size of the multiple PES single-channel hollow fiber filaments is 0.02 μm. The number of PES single-channel hollow fiber filaments is 500 - 3000. The multiple PES single-channel hollow fiber filaments are prepared from multiple polyethersulfone resins into hollow fiber filaments through electrospinning. A pressure detection device for detecting the internal pressure of the filtration column is further provided above the filtration column housing. A pressure detection port 6 is provided on the side of the upper part of the filtration column, and a pressure detection device is installed inside the filtration column to monitor the internal pressure of the filtration column through the pressure detection port 6 to maintain the pressure for the cells to normally perform the filtration function.

[0020] The above device of the present utility model is based on an in - depth understanding of the deficiencies in the prior art in the field of cell therapy, especially in response to the requirements for the safety and effectiveness of the plasma purification process in bioartificial liver therapy. The combination of PES single - channel hollow fiber filaments and PET non - woven fabric microcarriers adopted in the design aims to provide an environment that can not only efficiently purify plasma but also ensure cell viability, solving the limitations of traditional materials in terms of biocompatibility, physical stability, and purification efficiency. Its working principle is as Figure 2 shown.

[0021] 1. Structure and Materials

[0022] PES single - channel hollow fiber filaments: These slender filaments are made of high - performance polyethersulfone (PES), which is well - known for its excellent mechanical properties, chemical stability, and biocompatibility. The micro - pores precisely fabricated on the surface of the hollow fiber filaments can not only filter out cell debris and potential microcarrier - shedding fibers but also ensure the free flow of nutrients and therapeutic drugs in the plasma. In addition, the physical layout and spatial design of the PES filaments consider the kinetics of plasma flow to optimize the contact efficiency between cells and plasma.

[0023] PET non - woven fabric microcarriers: The selection of PET material is based on its good biocompatibility and structural stability. The open - fiber structure of the non - woven fabric provides an ideal environment for cell attachment and growth, supporting the three - dimensional distribution of cells, which is crucial for simulating natural liver function. At the same time, the PET microcarriers can withstand long - term biochemical reactions without being degraded, maintaining the consistency and reliability of the treatment process.

[0024] 2. Working Principle and Process

[0025] Plasma flow and purification: Plasma enters the interior of the device through the inlet on the side of the bottom of the purification column and first contacts the adherent cells on the cell carrier. During this process, harmful substances in the plasma are metabolically absorbed by the cells or undergo biotransformation. The purified plasma then enters the hollow PES hollow fiber filament pipeline and moves upward inside the device and is discharged through the outlet at the top.

[0026] 3. Pressure Monitoring and Regulation: The pressure monitoring port on the side is crucial for monitoring the stability of the purification process. Any abnormal pressure change may indicate flow obstacles or problems with the cell carrier. Timely monitoring and regulation can prevent these potential problems and ensure the smooth progress of the purification process.

[0027] The advantages of the present utility model are as follows:

[0028] (1) Enhanced biocompatibility and reduced material shedding

[0029] Limitations of the prior art: Although the materials used in many existing plasma purification devices can provide a certain degree of biocompatibility, they are prone to material wear or shedding after long-term use. Especially in the case of cell microcarrier materials, for example, the shedding of non-woven fibers may enter the blood circulation system, increasing the treatment risk. Advantages of the present utility model: By using two highly biocompatible and stable materials, PES and PET, the possibility of material shedding is significantly reduced. In particular, the single-channel filaments made of PES material, with their fine microporous design (0.02μm) on the surface, can not only effectively filter plasma, but also prevent cell debris, bacterial contaminants, and microfiber shedding from entering the human body, thereby enhancing the safety of the treatment.

[0030] (2) Improve purification efficiency and cell treatment effect

[0031] Limitations of the prior art: Traditional plasma purification technologies often have a balance problem between improving purification efficiency and maintaining cell viability. Although non-woven microcarriers have good cell adhesion, their structure may limit plasma flow and effective contact between cells, affecting the treatment effect. Advantages of the present utility model: By optimizing the structure and arrangement of PES hollow fiber filaments and PET non-woven microcarriers, the maximum contact area between plasma and cells is achieved, effectively improving the removal rate of toxic substances in plasma and the treatment efficacy of cells. At the same time, the precisely controlled pore size ensures plasma fluidity, further enhancing the purification efficiency.

[0032] (3) Enhance the stability and controllability of the treatment process

[0033] Limitations of the prior art: In existing purification systems, maintaining the stability of the internal pressure of the device is a challenge. Unstable pressure may cause damage to cell microcarriers, affecting the treatment effect. Advantages of the present utility model: The design of this device includes a pressure monitoring port on the side, enabling the operator to monitor and adjust the pressure inside the device in real time, ensuring the optimization of plasma flow and the state of cell carriers, and significantly improving the stability and controllability of the treatment.

[0034] In summary, in the field of bioartificial liver cell therapy, the present utility model demonstrates significant advantages and beneficial effects compared to the prior art through its unique design and material selection. These innovations not only improve the safety and efficiency of the treatment, but also lay the foundation for the future progress of cell therapy technologies.

Claims

1. An extracorporeal plasma biological purification device, characterized in that: The device comprises a purification column shell (1), a plasma inlet (2) at the lower end of the purification column shell and a plasma outlet (3) at the upper end, and a PET non-woven fabric microcarrier (4) and a plurality of PES single-channel hollow fibers (5) arranged in sequence from bottom to top inside the purification column shell; wherein the plurality of PES single-channel hollow fibers (5) are evenly arranged in parallel along the up-down direction inside the purification column, and the plurality of PES single-channel hollow fibers are all gathered at the upper end of the purification column and connected to the plasma outlet (3); the PET non-woven fabric microcarrier (4) is located between the plurality of PES single-channel hollow fibers (5) and at the lower part of the purification column.

2. The extracorporeal plasma biological purification device according to claim 1, characterized in that: The pore size of the plurality of PES single-channel hollow fibers is 0.02 μm.

3. The extracorporeal plasma biological purification device according to claim 1 or 2, characterized in that: The number of the PES single-channel hollow fiber filaments is 500-3000.

4. The extracorporeal plasma biological purification device according to claim 1, characterized in that: The plurality of PES single-channel hollow fiber filaments are prepared from a plurality of polyethersulfone resins by electrostatic spinning.

5. The extracorporeal plasma biological purification device according to claim 1, characterized in that: The device also includes a pressure detection device arranged above the purification column housing and used for detecting the internal pressure of the purification column.

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