An integrated plasma separation and adsorption column
Patent Information
- Application Number
- CN202521195881.7
- Authority / Receiving Office
- CN · China
- Patent Type
- Utility models(China)
- Current Assignee / Owner
- Filing Date
- 2025-06-12
- Publication Date
- 2026-08-21
- Estimated Expiration
- 2035-06-12
AI Technical Summary
但由于全血吸附固有的缺点,患者在治疗过程中会面临临床不良反应以及贫血等长期并发症的风险
[0035]本实用新型的有益效果为:本实用新型所述的一体化血浆分离与吸附柱,设计合理,通过一体化结构设计、合理的材料选择、精准的参数设置等多方面的优化,降低了患者治疗时低血压、血细胞损伤、血小板减少等风险,减少了长期并发症的发生,提高了治疗的安全性;采用高效的吸附材料,能够更精准地清除血浆中的致病物质,如β2微球蛋白、α1微球蛋白、肝炎病毒、炎性因子等,同时保留血液中的有益成分,提高了治疗效果;传统血浆吸附治疗需要额外的血浆分离器,而该一体化产品将血浆分离和吸附功能整合在一起,减少了设备和耗材的使用,使得血浆吸附治疗更加经济实惠,有利于推广和普及;一体化结构避免了传统血浆吸附治疗中复杂的管路连接,降低了医护人员的操作难度和操作时间,减少了操作失误的可能性。同时,分体设计的部件便于组装,提高了治疗设备的使用效率,具有广阔的应用前景。
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Figure CN224656444U_ABST
Abstract
Description
Technical Field
[0001] This utility model relates to the field of medical device technology, specifically to an integrated plasma separation and adsorption column. Background Technology
[0002] Blood adsorption, as a key method in blood purification therapy, plays an important role in clinical practice. It has advantages such as maintaining electrolyte balance, delaying complications, and improving organ function. It can also effectively remove medium and large molecular weight toxins, showing significant therapeutic effects on patients with acute poisoning. Blood adsorption is mainly divided into two treatment methods: whole blood adsorption and plasma adsorption.
[0003] Whole blood adsorption involves directly introducing blood into an adsorption column hemoperfusion device, allowing the blood to come into direct contact with adsorbent materials such as activated carbon and resin coated with biocompatible materials. The blood is then adsorbed before being reinfused into the body. This method is relatively simple to operate and has a low cost. For example, continuous hemodialysis treatment often uses whole blood adsorption.
[0004] Plasma adsorption involves first separating blood into plasma containing small molecules, including toxins, and blood cells, including red blood cells, white blood cells, and platelets, using a plasma separation membrane. Then, the plasma is introduced into an adsorption column to adsorb substances to be removed from the plasma, such as toxins. The adsorbed plasma is then mixed with the blood cells and injected into the body.
[0005] While whole blood adsorption has the advantages of simple operation and low cost, it also has significant drawbacks. While adsorbing small molecules, including toxins, whole blood adsorption also adsorbs and destroys some platelets, leading to thrombocytopenia and causing anemia in patients undergoing long-term whole blood adsorption therapy. Furthermore, complications such as hypotension and heart failure can occur during whole blood adsorption therapy. In addition, whole blood adsorption requires the use of large amounts of anticoagulants, which may cause coagulation disorders in patients.
[0006] Compared to whole blood adsorption, plasma adsorption has significant advantages. It does not damage or adsorb platelets, does not cause anemia in patients, and minimizes damage to blood cells during treatment. However, plasma adsorption also has some limitations. Currently, in addition to adsorption columns (such as hemoperfusion devices), plasma adsorption therapy also requires expensive plasma separators. The complex tubing connections and increased blood chamber volume during treatment increase the risk of hypotension in patients. These factors restrict the promotion and widespread adoption of plasma adsorption therapy.
[0007] Currently, whole blood adsorption therapy in China primarily utilizes whole blood adsorption. However, due to inherent drawbacks of whole blood adsorption, patients face risks of adverse clinical reactions and long-term complications such as anemia during treatment. Therefore, plasma adsorption is a safer and more effective alternative.
[0008] This invention proposes an integrated plasma separation-adsorption structure, which is an innovative solution based on existing blood adsorption therapy technology and aimed at addressing the shortcomings of whole blood adsorption and traditional plasma adsorption. It aims to improve the safety, effectiveness and scalability of blood adsorption therapy. Utility Model Content
[0009] Purpose of the utility model: In order to overcome the above shortcomings, the purpose of this utility model is to provide an integrated plasma separation and adsorption column. Through a reasonable integrated structural design, plasma separation and adsorption are achieved in one product, reducing the variety of consumables and the complexity of operation for medical staff during plasma adsorption therapy, reducing blood chamber volume, reducing the risk of hypotension, reducing blood cell damage and thrombocytopenia during treatment, improving the safety and effectiveness of treatment, and reducing long-term complications with continuous treatment, thus providing an optimized solution for the market.
[0010] Technical Solution: An integrated plasma separation and adsorption column includes a plasma separator and an adsorption column. The adsorption column is located at the lower part of the plasma separator and forms an integrated structure with the plasma separator. The plasma separator includes a plasma separation shell, a plasma separation membrane, and a guide tube. The interior of the plasma separation shell is divided into a blood inlet section, a plasma separation section, and a blood cell outflow section from top to bottom. The plasma separation membrane is located within the plasma separation section. The plasma separation shell has a plasma overflow outlet at the bottom of the plasma separation section. The guide tube is located below the plasma separation shell, and its upper end communicates with the interior of the blood cell outflow section. The adsorption column includes an adsorption column shell and an adsorption assembly. The adsorption column shell is located at the lower part of the plasma separation shell and is connected to the plasma separation shell. The interior of the adsorption column shell is divided into a plasma inlet section, an adsorption section, and a mixing-outflow section from top to bottom. The plasma inlet section is located outside the plasma overflow outlet at the bottom of the plasma separation section. The adsorption assembly is located inside the adsorption section. The guide tube is also located inside the adsorption section, and its lower end extends into the mixing-outflow section.
[0011] The integrated plasma separation and adsorption column of this invention integrates plasma separation and adsorption functions into a single product, avoiding the complex piping problems caused by the separation of the plasma separator and adsorption column in traditional plasma adsorption therapy, thus simplifying the structure of the treatment equipment. Traditional plasma adsorption therapy, due to the addition of a plasma separator, increases the blood chamber volume, easily leading to adverse reactions such as hypotension. This integrated structure effectively solves this problem, improving treatment safety. The integrated structure reduces blood cell damage and thrombocytopenia during treatment. Because in the integrated structure, blood is separated and adsorbed in a relatively closed and continuous environment, reducing contact and collision between blood cells and the external environment, thus lowering the probability of blood cell damage.
[0012] The procedure for plasma adsorption therapy using the integrated plasma separation and adsorption column described in this invention is as follows: 1. The patient establishes blood circulation by draining blood from the body through vascular access such as central venous catheterization or arteriovenous fistula puncture.
[0013] 2. Blood enters the plasma separator at a set flow rate.
[0014] 3. In the plasma separation section, blood is separated into plasma and blood cells by the plasma separation membrane. The plasma flows into the adsorption column through the plasma overflow outlet, while the unseparated blood and the separated blood cells flow to the lower end of the adsorption column through the guide tube.
[0015] 4. Plasma comes into contact with the adsorption components inside the adsorption column. If blood purification treatment is performed, toxins such as β2 microglobulin and α1 microglobulin in the plasma are adsorbed. If hepatitis B treatment is performed, hepatitis virus is specifically adsorbed while ordinary substances are adsorbed.
[0016] 5. The adsorbed plasma flows to the lower end of the adsorption column and mixes with the blood and blood cells flowing out from the guide tube.
[0017] 6. The mixed blood flows out through the adsorption column and is then reinfused into the patient through a vascular access.
[0018] Preferably, when the integrated plasma separation and adsorption column is working, blood enters through the blood inlet at a flow rate of 200-220 ml / min, keeping the plasma separation ratio between 10% and 20% of the blood flow. Within this range, some blood can be continuously separated into plasma and blood cells, facilitating smooth plasma adsorption. Simultaneously, this prevents excessive increases in the patient's blood concentration, which could affect blood circulation and increase the risk of blood clotting. In practical applications, the blood flow and plasma separation ratio can be adjusted within a specified range according to the patient's specific condition to achieve personalized treatment. A reasonable blood flow and plasma separation ratio setting ensures the stability of the treatment effect.
[0019] Furthermore, in the aforementioned integrated plasma separation and adsorption column, the plasma separation shell includes a blood inlet cap, a plasma separation membrane main shell, and a guide tube; the blood inlet cap is located at the blood inlet section and is connected to the plasma separation membrane main shell.
[0020] The separate design of the blood inlet cap and the main body of the blood separation membrane facilitates product assembly. The connection between the blood inlet cap and the main body of the blood separation membrane must ensure good sealing performance to prevent blood leakage. During the process of blood entering the plasma separator, a good seal ensures that the blood flows along the predetermined path, guaranteeing the effectiveness of plasma separation.
[0021] Furthermore, in the aforementioned integrated plasma separation and adsorption column, the plasma overflow outlets are distributed in a circumferential array on the plasma separation shell.
[0022] The circumferentially arrayed plasma overflow outlets ensure uniform plasma flow from the plasma separation shell into the adsorption column. This guarantees even distribution of plasma within the column, enhancing adsorption efficiency. Uniform plasma outflow further improves plasma separation efficiency, allowing more plasma to enter the adsorption column for processing promptly. This enables the processing of more blood within the same timeframe, thus increasing treatment efficiency.
[0023] Furthermore, in the aforementioned integrated plasma separation and adsorption column, the adsorption column shell includes an adsorption column main shell and a blood outlet cap. The blood outlet cap is located at the mixing-ejection section and is connected to the adsorption column main shell. The separate design of the adsorption column main shell and the blood outlet cap facilitates product assembly.
[0024] Furthermore, in the aforementioned integrated plasma separation and adsorption column, the adsorption component includes an annular upper filter, an annular lower filter, and adsorption material. The annular upper filter and the annular lower filter are respectively disposed at the upper and lower ends of the adsorption section, and the adsorption material is filled inside the adsorption section.
[0025] The annular upper and lower filters fix the adsorbent material within the adsorption section, preventing it from shifting or being lost during plasma flow. This ensures the adsorbent material remains in an effective adsorption position, improving adsorption efficiency. The annular upper and lower filters also prevent the adsorbent material from mixing with plasma and blood cells and flowing into the body, thus avoiding significant treatment risks.
[0026] Furthermore, in the aforementioned integrated plasma separation and adsorption column, the plasma separation shell, the guide tube, and the adsorption column shell are made of one or more of PP, PC, PET, and ABS. The annular upper filter and the annular lower filter are made of nylon.
[0027] PP, PC, PET, ABS, and nylon materials all possess good biocompatibility, reducing adverse reactions upon contact with blood. During treatment, these materials do not adversely affect blood components, ensuring treatment safety. These materials also possess sufficient strength and toughness to meet the requirements for plasma separation shells and drainage tubes.
[0028] Furthermore, in the aforementioned integrated plasma separation and adsorption column, the plasma separation membrane is made of one or more of polyethylene, polysulfone, and polyethersulfone; the membrane area of the plasma separation membrane is between 0.2 and 0.8 m².
[0029] Membranes made of materials such as polyethylene, polysulfone, and polyethersulfone possess excellent separation properties, effectively separating blood into plasma and blood cells. The pore size and structure of these membranes can be adjusted as needed to achieve optimal separation results. The membrane area is adjustable between 0.2 and 0.8 m², allowing for selection of a suitable membrane area based on the patient's weight.
[0030] Furthermore, in the aforementioned integrated plasma separation and adsorption column, the adsorption material is one or more of activated carbon, resin, and carbonized resin. Activated carbon, resin, and carbonized resin, among other adsorption materials, possess a large specific surface area and abundant pore structure, enabling them to efficiently adsorb target substances in plasma, such as β2-microglobulin, α1-microglobulin, light chains, parathyroid hormone, hepatitis virus, and inflammatory factors. The pore size of the annular upper filter is 100-500 mesh, and the pore size of the annular lower filter is also 100-500 mesh. Appropriate filter pore sizes ensure that the adsorption material remains within the adsorption zone, preventing it from mixing with plasma and blood cells and flowing into the body, thus avoiding significant risks.
[0031] Preferably, the adsorbent material is a material for which antibodies are grafted onto the surface of activated carbon or resin via chemical coupling.
[0032] The specific steps are as follows: Activated carbon or resin is activated to make its surface have active groups; then the antibody is mixed with the activated activated carbon or resin in a specific buffer solution and reacted under certain temperature and time conditions to make the antibody covalently bind to the active groups on the surface of the activated carbon or resin.
[0033] Antibodies are grafted onto the surface of activated carbon or resin using chemical coupling, giving the adsorbent material specific adsorption capabilities. Antibodies can specifically bind to target substances (such as hepatitis viruses, inflammatory factors, etc.), thereby more precisely clearing pathogens from plasma and improving the targeting of treatment. Compared with traditional adsorbent materials, antibody-grafted adsorbent materials can adsorb target substances more quickly and effectively. This is because the binding of antibodies to target substances has high specificity and affinity, enabling the capture of large amounts of target substances in a short time.
[0034] Preferably, the volume of the adsorbent material is set according to a standard of 1.5~2 ml / kg of patient weight. Selecting the volume of the adsorbent material based on the patient's weight ensures a precise match between the material and the patient's physical condition. Patients of different weights have different blood volumes and different amounts of target substances that need to be removed. Selecting the volume of the adsorbent material according to this standard ensures effective adsorption while avoiding waste or insufficiency. An appropriate volume of adsorbent material can reduce adverse effects on the patient's body. If the volume of the adsorbent material is too large, it may lead to excessive adsorption of beneficial components in the blood; if the volume is too small, an effective therapeutic effect cannot be achieved.
[0035] The beneficial effects of this invention are as follows: The integrated plasma separation and adsorption column of this invention is rationally designed. Through optimization in multiple aspects such as integrated structural design, reasonable material selection, and precise parameter settings, it reduces the risks of hypotension, blood cell damage, and thrombocytopenia during patient treatment, reduces the occurrence of long-term complications, and improves the safety of treatment. The use of highly efficient adsorption materials enables more precise removal of pathogenic substances in the plasma, such as β2-microglobulin, α1-microglobulin, hepatitis viruses, and inflammatory factors, while retaining beneficial components in the blood, thus improving the therapeutic effect. Traditional plasma adsorption therapy requires an additional plasma separator, while this integrated product combines plasma separation and adsorption functions, reducing the use of equipment and consumables, making plasma adsorption therapy more economical and conducive to promotion and popularization. The integrated structure avoids the complex pipeline connections in traditional plasma adsorption therapy, reducing the operational difficulty and time for medical staff, and reducing the possibility of operational errors. At the same time, the modular design of the components facilitates assembly, improves the efficiency of the treatment equipment, and has broad application prospects. Attached Figure Description
[0036] Figure 1 This is a schematic diagram of the integrated plasma separation and adsorption column of this utility model; Figure 2 This is a schematic diagram of the structure of the plasma separator of the integrated plasma separation and adsorption column of this utility model; Figure 3 This is a schematic diagram of the structure of the adsorption column of the integrated plasma separation and adsorption column of this utility model; Figure 4 This is a flowchart illustrating the use of the adsorption column in the integrated plasma separation and adsorption column of this invention. In the picture: Plasma separation shell 1, plasma separation membrane main shell 11, blood inlet section 101, plasma separation section 102, blood cell outflow section 103, plasma overflow outlet 104, blood inlet cover 12, plasma separation membrane 2, guide tube 3, adsorption column shell 4, adsorption column main shell 41, plasma inlet section 401, adsorption section 402, mixing-outflow section 403, blood outlet cover 42, adsorption assembly 5, annular upper filter screen 51, annular lower filter screen 52, adsorption material 53. Detailed Implementation
[0037] The following is in conjunction with the appendix Figure 1 , 2 Examples 1, 2, and 3 further illustrate this utility model.
[0038] The following Examples 1 and 2 provide a structure for an integrated plasma separation and adsorption column.
[0039] Example 1 like Figure 1 As shown, the integrated plasma separation and adsorption column of this utility model includes a plasma separator and an adsorption column. The adsorption column is disposed at the lower part of the plasma separator and forms an integrated structure with the plasma separator.
[0040] like Figure 1 , 2 As shown, the main function of the plasma separator is to separate blood into plasma and blood cells. The relevant components include: plasma separator shell 1, plasma separator membrane 2, and guide tube 3.
[0041] The plasma separation shell 1 includes a blood inlet cap 12, a plasma separation membrane main shell 11, and a flow guide tube 3. The blood inlet cap 12 serves as the inlet of the integrated plasma separation and adsorption column. After the patient's blood is drawn through a vascular access, it enters the integrated plasma separation and adsorption column at a set flow rate via the blood inlet cap 12. It is located at the top of the entire device and is the starting point for blood entry. The plasma separation membrane main shell 11 houses the plasma separation membrane 2, providing a relatively independent space for blood separation. It is connected to the blood inlet cap 12, allowing blood to enter directly into the plasma separation membrane main shell 11 after entering through the blood inlet cap 12. The plasma separation membrane 2 is the core component of plasma separation, located inside the plasma separation membrane main shell 11. Under its action, blood is separated into plasma and blood cells. The flow guide tube 3 guides the separated blood cells to the lower end of the adsorption column. Its upper end is connected to the plasma separation shell 1 to receive the separated blood cells, and its lower end extends to the lower end of the adsorption column, allowing the blood cells to smoothly reach the position where they mix with the adsorbed plasma.
[0042] Furthermore, such as Figure 2As shown, the interior of the plasma separation shell 1 is divided into a blood inlet section 101, a plasma separation section 102, and a blood cell outflow section 103 from top to bottom. The plasma separation membrane 2 is disposed inside the plasma separation section 102. The plasma separation shell 1 is provided with a plasma overflow outlet 104 at the bottom of the plasma separation section 102. The guide tube 3 is disposed below the plasma separation shell 1 and its upper end is connected to the interior of the blood cell outflow section 103.
[0043] like Figure 1 , 3 As shown, the main function of the adsorption column is to adsorb the separated plasma and remove the target substances therein. The relevant components include: the adsorption column shell 4 and the adsorption assembly 5.
[0044] The adsorption column housing 4 includes an adsorption column main housing 41 and a blood outlet cover 42. The adsorption column main housing 41 provides a closed space for the adsorption process, accommodating the adsorption assembly 5. It is connected to the plasma separation housing 1, and plasma flows in from the plasma overflow outlet 104 and enters the adsorption column main housing 41. The blood outlet cover 42 is the outlet for the integrated plasma separation and adsorption column, located at the bottom of the device. The mixed blood flows out through the blood outlet cover 42 and is reinfused into the patient through a vascular pathway. The adsorption assembly 5 includes an annular upper filter 51, an annular lower filter 52, and adsorption material 53. The annular upper filter 51 is located in the upper part of the adsorption column main housing 41, and plasma first passes through this filter when it flows into the adsorption column main housing 41. The adsorption material 53 is the key material for adsorption, filling the interior of the adsorption column main housing 41. Plasma comes into contact with these materials inside the adsorption column main housing 41, adsorbing target substances such as β2-microglobulin, α1-microglobulin, hepatitis virus, and inflammatory factors. The annular lower filter 52 is located in the lower part of the main shell 41 of the adsorption column. The adsorbed plasma flows out through this filter, which can prevent the adsorbent material from flowing out with the plasma.
[0045] Furthermore, such as Figure 3 As shown, the interior of the adsorption column shell 4 is divided into a plasma inlet section 401, an adsorption section 402, and a mixing-outlet section 403 from top to bottom. The plasma inlet section 401 is located outside the plasma overflow port 14 at the bottom of the plasma separation section 102. The adsorption assembly 5 is disposed inside the adsorption section 402, and the guide tube 3 is also disposed inside the adsorption section 402 with its lower end extending into the mixing-outlet section 403.
[0046] Example 2 Based on the structural foundation of Embodiment 1, the integrated plasma separation and adsorption column of this utility model has plasma overflow outlets 104 distributed in a circumferential array on the plasma separation shell 1, which enables plasma to flow more evenly from the plasma separation section into the adsorption column, ensuring the efficiency and effectiveness of plasma separation and avoiding local accumulation or poor flow of plasma.
[0047] Furthermore, in this utility model, the integrated plasma separation and adsorption column, including the plasma separation shell 1 (plasma separation membrane main shell 11, blood inlet cap 12), the guide tube 3, and the adsorption column shell 4 (adsorption column main shell 41, blood outlet cap 42), is made of one or more of PP, PC, PET, and ABS. The annular upper filter screen 51 and the annular lower filter screen 52 are made of nylon.
[0048] PP, PC, PET, ABS, and nylon materials possess good biocompatibility, reducing adverse reactions upon contact with blood. During treatment, these materials do not adversely affect blood components, ensuring treatment safety. These materials also possess sufficient strength and toughness to meet the requirements for plasma separation shells and drainage tubes.
[0049] Furthermore, the plasma separation membrane 2 is made of one or more of polyethylene, polysulfone, and polyethersulfone, and its membrane area is between 0.2 and 0.8 m². Membranes made of these materials have excellent separation performance, effectively separating blood into plasma and blood cells. The membrane area is between 0.2 and 0.8 m² (typically 0.2, 0.5, or 0.8 m²), allowing for the selection of an appropriate membrane area based on different treatment needs to achieve optimal plasma separation results.
[0050] Furthermore, the membrane size parameters of plasma separation membrane 2 are: inner diameter 330 μm, wall thickness 50 μm, and average pore size 0.3 μm.
[0051] When the blood flow rate is 200~220ml / min, the plasma separation ratio of plasma separation membrane 2 reaches about 10~20% of the blood flow rate.
[0052] Furthermore, the annular upper filter 51 has a pore size of 150-500 mesh, and the annular lower filter 52 has a pore size of 150-500 mesh; the adsorbent material 53 is made of activated carbon, resin, carbonized resin, or one or more of which have antibodies grafted onto the activated carbon or resin via chemical coupling. Using chemical coupling to graft antibodies onto the surface of activated carbon or resin gives the adsorbent material higher specificity, enabling more precise adsorption of target substances, such as specific viruses and inflammatory factors, thus improving the targeting and efficacy of treatment.
[0053] Furthermore, the volume of the adsorbent material is selected according to the standard of 1.5~2 ml / kg of patient weight, which can provide personalized treatment plans based on individual patient differences, ensuring the effectiveness and safety of the treatment.
[0054] Furthermore, the integrated plasma separation and adsorption column of this utility model has a complex shell structure, which cannot be produced using traditional plastic injection molding processes. It is necessary to use injection molding, blow molding or extrusion processes to form individual plastic parts, and then use laser, ultrasonic or hot melt welding to weld the individual plastic parts into an integrated plastic shell.
[0055] Based on the structural foundation of Examples 1 and 2, Example 3 provides a process for plasma adsorption therapy using an integrated plasma separation and adsorption column.
[0056] Example 3 like Figure 4 As shown, the process of plasma adsorption therapy using the integrated plasma separation and adsorption column of this invention is as follows: 1. By puncturing the patient's blood passage, the patient's blood is drawn out and enters the blood inlet section 101 through the blood inlet cap 12; 2. Blood passes through plasma separation membrane 2, separating plasma from blood cells; 3. The separated plasma flows downward inside the plasma separation section 102, flows out of the main shell 11 of the plasma separation membrane through several plasma overflow outlets 104, and the separated blood cells flow downward through the blood cell conduit 3. 4. The plasma enters the plasma inlet section 401 of the adsorption column shell 4 from the plasma overflow outlet 104, and then enters the adsorption section 402 through the annular upper filter screen 51. The adsorption section 402 is filled with adsorption material 53 in the space inside the main shell 41 of the adsorption column and outside the guide tube 3 to adsorb substances in the plasma, including β2 microglobulin, α1 microglobulin, hepatitis B virus and other medium and large molecular toxins. 5. After being adsorbed, the plasma flows further down in the adsorption section 402 and into the mixing-outflow section 403, that is, inside the blood outlet cover 42. It mixes with the blood cells and blood mixture flowing out from the guide tube 3, and after flowing out of the blood outlet cover 42, it is returned to the patient through the vascular access.
[0057] It is important to note that in clinical practice, traditional plasma separation and adsorption column therapy controls the proportion of plasma separated from the total blood volume by controlling the blood flow rate corresponding to the area of the plasma separation membrane. The blood flow rate and plasma separation ratio have a linear relationship. However, there can be slight differences in the pore size and porosity of plasma separation membranes from different brands. Therefore, in actual treatment, there may be slight variations in the blood flow rate and plasma separation ratio. The appropriate blood flow rate parameter should be set based on the performance of the plasma separation membrane used, ensuring separation of 20% of the total blood volume. Online monitoring and timely adjustments should be made during treatment.
[0058] In addition, monitoring the blood pressure at the blood inlet and outlet can further improve the accuracy of plasma separation ratio. At the same time, by monitoring the blood pressure at the blood inlet and outlet, it is possible to detect in a timely manner the occurrence of coagulation in the plasma separation membrane or pinhole damage to the plasma separation membrane, and to take rapid action to prevent the occurrence of risks in the treatment process.
[0059] Clinically, increasing blood flow rate, or blood flow velocity, can increase the plasma separation ratio, and simultaneously, the blood pressure at the blood inlet and outlet will also increase. Conversely, decreasing blood flow rate, or blood flow velocity, will decrease the plasma separation ratio, and the blood pressure at the blood inlet and outlet will decrease. The treatment equipment can monitor and provide feedback on these parameters online, and can adjust them accordingly. If the blood flow rate and blood flow velocity remain constant, but the blood pressure at the blood inlet and outlet fluctuates, it should be considered whether there is coagulation in the plasma separation membrane or whether there is a pinhole leak in the separation membrane. In this case, the treatment equipment will also issue an alarm.
[0060] Clinically, the efficacy of blood adsorption therapy is evaluated by comparing the reduction in blood component levels before and after adsorption. For example, enzyme-linked immunosorbent assay (ELISA) is used to detect the concentration of the target substance in plasma before and after adsorption, and the adsorption rate is calculated; the effectiveness of adsorption therapy is also assessed by observing changes in the patient's clinical symptoms and biochemical indicators.
[0061] In summary, the integrated plasma separation and adsorption column of this invention has the following advantages: (1) Improve the safety and effectiveness of treatment: Through the integrated structural design, the damage to blood cells and platelet reduction during treatment are reduced, the risk of complications such as hypotension is reduced, and the efficiency and effect of plasma separation and adsorption are improved. The target substances can be adsorbed more accurately, thus improving the safety and effectiveness of treatment and reducing the occurrence of long-term complications.
[0062] (2) Reduced cost and operational complexity: The integrated structure reduces the variety of consumables required for plasma adsorption therapy, thereby reducing costs. At the same time, it simplifies the connection of consumables, the operation of the device and medical staff, making plasma adsorption therapy more convenient and easier to implement, which is conducive to the wider application of this treatment method.
[0063] (3) Personalized treatment and precision medicine: By selecting adsorbent materials, determining their volume and optimizing parameters, personalized treatment plans can be provided based on the patient's condition and individual differences, thereby achieving precision medicine and improving treatment effectiveness.
[0064] (3) Promoting the development of plasma adsorption therapy: The design of this integrated plasma separation and adsorption column solves the problems existing in traditional plasma adsorption therapy, provides new ideas and methods for the development of plasma adsorption therapy technology, and is expected to promote the wider application of plasma adsorption therapy in clinical practice, bringing good news to more patients.
[0065] The above description is only a preferred embodiment of the present utility model. It should be noted that for those skilled in the art, several improvements can be made without departing from the principle of the present utility model, and these improvements should also be considered within the protection scope of the present utility model.
Claims
1. An integrated plasma separation and adsorption column, characterized in that, The system includes a plasma separator and an adsorption column, wherein the adsorption column is located at the lower part of the plasma separator and forms an integrated structure with the plasma separator; wherein the plasma separator includes a plasma separation shell (1), a plasma separation membrane (2), and a guide tube (3), wherein the interior of the plasma separation shell (1) is divided into a blood inlet section (101), a plasma separation section (102), and a blood-blood cell outflow section (103) from top to bottom, the plasma separation membrane (2) is located inside the plasma separation section (102), the plasma separation shell (1) is provided with a plasma overflow outlet (104) at the bottom of the plasma separation section (102), and the guide tube (3) is located below the plasma separation shell (1) and its upper end is connected to the blood - The blood cell outflow section (103) is internally connected; the adsorption column includes an adsorption column shell (4) and an adsorption component (5); the adsorption column shell (4) is located at the lower part of the plasma separation shell (1) and is connected to the plasma separation shell (1); the interior of the adsorption column shell (4) is divided into a plasma inflow section (401), an adsorption section (402), and a mixing-outflow section (403) from top to bottom; the plasma inflow section (401) is located outside the plasma overflow port (104) at the bottom of the plasma separation section (102); the adsorption component (5) is located inside the adsorption section (402); the guide tube (3) is also located inside the adsorption section (402) and its lower end extends into the mixing-outflow section (403).
2. The integrated plasma separation and adsorption column according to claim 1, characterized in that, The plasma separation shell (1) includes a blood inlet cap (12), a plasma separation membrane main shell (11), and a guide tube (3). The blood inlet cap (12) is located at the blood inlet section (101) and is connected to the plasma separation membrane main shell (11).
3. The integrated plasma separation and adsorption column according to claim 1, characterized in that, The plasma overflow outlets (104) are arranged in a circular array on the plasma separation shell (1).
4. The integrated plasma separation and adsorption column according to claim 1, characterized in that, The adsorption column housing (4) includes an adsorption column main housing (41) and a blood outlet cover (42); the blood outlet cover (42) is located at the mixing-outflow section (403) and is connected to the adsorption column main housing (41).
5. The integrated plasma separation and adsorption column according to claim 1, characterized in that, The adsorption component (5) includes an annular upper filter (51), an annular lower filter (52), and adsorption material (53). The annular upper filter (51) and the annular lower filter (52) are respectively disposed at the upper and lower ends of the adsorption section (402), and the adsorption material (53) is filled inside the adsorption section (402).
6. The integrated plasma separation and adsorption column according to claim 1, characterized in that, The materials of the plasma separation shell (1), the guide tube (3), and the adsorption column shell (4) are one or more of PP, PC, PET, and ABS.
7. The integrated plasma separation and adsorption column according to claim 1, characterized in that, The plasma separation membrane (2) is made of one or more of polyethylene, polysulfone, and polyethersulfone; the membrane area of the plasma separation membrane (2) is between 0.2 and 0.8 m².
8. The integrated plasma separation and adsorption column according to claim 5, characterized in that, The annular upper filter (51) has a pore size of 100-500 mesh, and the annular lower filter (52) has a pore size of 100-500 mesh; the materials of the annular upper filter (51) and the annular lower filter (52) are nylon; the adsorption material (53) is one or more of activated carbon, resin, and carbonized resin.