CN109663385B - Plasma methylene blue virus inactivation and filtration device and preparation method thereof - Google Patents
Plasma methylene blue virus inactivation and filtration device and preparation method thereof Download PDFInfo
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- B—PERFORMING OPERATIONS; TRANSPORTING
- B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
- B01D—SEPARATION
- B01D15/00—Separating processes involving the treatment of liquids with solid sorbents; Apparatus therefor
- B01D15/08—Selective adsorption, e.g. chromatography
- B01D15/10—Selective adsorption, e.g. chromatography characterised by constructional or operational features
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Abstract
The invention discloses a plasma methylene blue virus inactivation and filtration device and a preparation method thereof. According to the invention, the filtering material non-woven fabric and the carbon fiber are separated to form a plurality of independent filtering function areas with cavities, and multiple filtration of a leaching tower type can be realized, so that the utilization efficiency of the filtering material can be effectively improved, the removal rate of methylene blue is improved, the loss of plasma is reduced, the filtering performance is stable, and the influence caused by protein precipitation and floccule precipitation in the plasma is effectively reduced.
Description
Technical Field
The invention relates to a medical device and a preparation method thereof, in particular to a plasma methylene blue virus inactivation and filtration device and a preparation method thereof.
Background
The plasma virus-inactivating component product is a substitute product of the plasma product, and aims to prevent high risk of virus infection after plasma infusion. The current method for inactivating the plasma of the methylene blue virus, which is commonly used worldwide, can effectively inactivate lipid-coated viruses and partial non-lipid-coated viruses in the plasma, such as: HBV, HCV, HIV, etc., a hazardous virus that must be detected and controlled by the health administration. The effect of the methylene blue virus-inactivated plasma filter device is to remove residual methylene blue in plasma after photochemical treatment of the methylene blue, so that the methylene blue content in the methylene blue virus-inactivated plasma is reduced as much as possible, and the exposure risk of the methylene blue during large-dose infusion is minimized; and simultaneously, white blood cells in the plasma are removed so as to reduce the occurrence of transfusion reactions such as FNHTR and the like.
The filters used in the market at present are flat disc-shaped or square, the filter materials (comprising non-woven fabrics and carbon fibers) are fixed in the filter shell in a tight pressing mode, and then the filter shell is sealed in a welding or heat sealing mode. The filtration modes are side osmosis methods, namely, the inlet and the outlet are parallel to the filtration surface. In practical application, in order to ensure the effective removal effect of methylene blue and white blood cells, the flat filter surface needs to have larger diameter, generally from 40mm to 70mm, and even 100mm diameter is adopted for the inactivated plasma of more than 300ml of methylene blue viruses abroad; not only increases the cost, but also greatly increases the loss of plasma. In addition, due to the large filtration surface area, when plasma enters the filter material from the inlet face of the filtration, the liquid to be filtered often passes through the easy-to-filter part, and the filter material cannot be fully soaked until the filtration is finished, so that the effective utilization rate of the filter material is low. On the other hand, because the non-woven fabrics and the carbon fiber materials are tightly laminated in the filter, no buffer space exists in the middle, and the filter is easy to be blocked due to the problems of precipitation of a small amount of fibrin in the blood plasma and the like in the actual use process, thereby affecting the filtering effect and even leading to the failure of completing the filtering process when serious.
Disclosure of Invention
The invention aims to solve the technical problems that the plasma content is 100 ml-500 ml, especially the plasma content of more than 200ml, and provides a plasma methylene blue virus inactivation and filtration device and a preparation method thereof, which can effectively improve the utilization rate of a filtration material, improve the removal rate of methylene blue, reduce the loss of plasma, and have stable filtration performance, thereby effectively reducing the influence caused by protein precipitation and floccule precipitation in the plasma.
The invention provides a plasma methylene blue virus inactivation and filtration device which aims at solving the technical problems and comprises an inlet pipe cavity, an outlet pipe cavity and a plurality of sections of middle pipe cavities, wherein a filter layer is arranged at the joint of two adjacent pipe cavities, and a rough filtration area, a methylene blue adsorption area and a leukocyte removal area are sequentially formed at the joint of the pipe cavities from the inlet to the outlet.
Further, the coarse filtration area consists of a plurality of layers of non-woven fabrics with larger aperture, the aperture of the non-woven fabrics is 70-100 μm, and the number of layers is 1-4; the leucocyte removing area consists of a plurality of layers of non-woven fabrics with thinner pore diameters, the pore diameters are 12-21 mu m, and the number of layers is 2-4.
Further, the number of layers of the nonwoven fabric in the leukocyte removal zone is 4, and the pore diameter is 12 μm to 21 μm, and the gradient decreases from 21 μm, 18 μm, 15 μm to 12 μm in order from the inlet to the outlet.
Further, an intermediate lumen and a filter layer are arranged between the leucocyte removing area and the outlet lumen, and the filter layer is formed by 10-14 layers of non-woven fabrics with the aperture of 0.65-0.22 mu m.
Further, the methylene blue adsorption zone is formed by combining carbon fibers and non-woven fabrics, the total thickness of the carbon fibers is between 4 and 12mm, the aperture of the non-woven fabrics is between 21 and 35 mu m, and the number of layers is between 1 and 2; the non-woven fabric is sandwiched between or spaced apart from the carbon fibers.
Further, the number of layers of the non-woven fabrics in the methylene blue adsorption area is two, the aperture of one non-woven fabric layer is gradually changed from 21 mu m to 35 mu m along the pipe wall to the center of the pipe cavity, and the aperture of the other non-woven fabric layer is gradually changed from 35 mu m to 21 mu m along the pipe wall to the center of the pipe cavity.
Further, the space volume of the multi-section intermediate lumen is controlled to be 100-3000 cubic millimeters.
Further, the inner wall of the middle tube cavity is provided with a diversion trench which spirals forwards along the flowing direction of the blood plasma; and the spiral directions of the diversion trenches on the inner walls of the middle cavities at two sides of the methylene blue adsorption area are opposite.
The invention also provides a preparation method of the plasma methylene blue virus inactivation and filtration device, which comprises the following steps: s1, firstly, injection molding to form an inlet pipe cavity, an outlet pipe cavity and a plurality of sections of intermediate pipe cavities, forming a step structure outside one end edge of the intermediate pipe cavity, forming a step structure inside the other end edge, forming a step structure inside or outside the lower end edge of the inlet pipe cavity, and forming a step structure inside or outside the upper end edge of the outlet pipe cavity; s2, then, superposing and compacting the non-woven fabrics and the carbon fibers, cutting to form a filter layer, and then, mixing tetrahydrofuran and cyclohexanone according to a ratio of 2:1, mixing the materials as an adhesive, and tightly fixing a filter layer on a step at the joint of each lumen; and S3, finally bonding all the tube cavities together through an adhesive, wherein the central axis of the whole tube cavity from the inlet tube cavity to the outlet tube cavity is a straight line, so that the leaching tower type multiple filtration is formed.
Further, the material of the inlet lumen, the outlet lumen and the multi-section middle lumen is soft medical plastic or hard medical plastic, the filter layer is tightly fixed at the joint of the lumens in an adhesive mode, and the total length of the connected lumens is 4 cm-6 cm; the diameter of the middle lumen is 20-25 mm, the diameters of the inlet end and the outlet end of the inlet lumen are smaller than the diameter of the middle lumen, and the diameters of the other ends of the inlet lumen and the outlet lumen are consistent with the diameter of the middle lumen; when the material of the lumen is hard medical plastic, the lumen is bonded by adopting UV glue, and the light curing treatment is carried out for 5-10 s to enhance the bonding firmness.
Compared with the prior art, the invention has the following beneficial effects: the plasma methylene blue virus inactivation filter device and the preparation method thereof provided by the invention are different from the existing filtration mode of tightly laminating and penetrating the non-woven fabric of the filter material and the carbon fiber, the non-woven fabric of the filter material and the carbon fiber are separated to form a plurality of independent filtration function areas, each filtration unit is provided with a buffer space for storing waste, and the multi-filtration of a leaching tower type is realized, so that the removal rate of methylene blue can be effectively improved, the loss of plasma is reduced, the filtration performance is stable, the filtration effect is effectively improved, and the blocking influence caused by plasma protein precipitation and floccule precipitation is reduced.
Drawings
FIG. 1 is a schematic diagram of the plasma methylene blue virus inactivating filter apparatus according to the present invention.
Detailed Description
The invention is further described below with reference to the drawings and examples.
FIG. 1 is a schematic diagram of the structure of an inventive plasma methylene blue virus inactivation filter.
Referring to fig. 1, the plasma methylene blue virus inactivation and filtration device provided by the invention comprises an inlet pipe cavity 1, an outlet pipe cavity 3 and a plurality of sections of middle pipe cavities 2, wherein a filter layer is arranged at the joint of two adjacent pipe cavities, and a rough filtration area 4, a methylene blue adsorption area 5 and a leukocyte removal area 6 are sequentially formed at the joint of the pipe cavities from the inlet to the outlet. The invention separates the non-woven fabric of the filtering material and the carbon fiber and forms an independent filtering function area, and is divided into a rough filtering area 4, a methylene blue adsorption area 5 and a leucocyte removing area 6; the areas are connected by a plurality of sections of intermediate tube cavities 2 and are tightly fixed at the connecting positions in the tube cavities in a gluing mode and the like; multiple filtration in the form of a leaching tower can be achieved.
The plasma methylene blue virus inactivating and filtering device provided by the invention is characterized in that the rough filtering area 4 consists of a plurality of layers of non-woven fabrics with larger pore diameters, the pore diameters of the non-woven fabrics are more than 70 mu m, preferably 70 mu m to 100 mu m, the number of layers is 1 to 4, and the fibrous protein precipitation and floccule precipitation in the plasma are primarily filtered out, so that the anti-blocking effect is realized. Compared with the existing filtering mode, the anti-blocking capability of the coarse filtering layer is obviously improved, the coarse filtering layer is mainly characterized by high and relatively stable filtering speed, smaller filtering time deviation, shortened filtering time and contribution to shortening the working time of operators
The plasma methylene blue virus inactivation and filtration device is characterized in that the methylene blue adsorption zone 5 is formed by combining carbon fibers and non-woven fabrics, wherein the total thickness of the carbon fibers is between 4 and 12mm, the aperture of the non-woven fabrics is between 21 and 35 mu m, and the number of layers is between 1 and 2; the carbon fiber adsorbs the methylene blue, and the non-woven fabric is clamped between the carbon fibers or placed at intervals to play a certain flow rate regulating role, so that the adsorption effect of the methylene blue is enhanced.
Preferably, the number of layers of the non-woven fabrics in the methylene blue adsorption zone 5 is two, wherein the aperture of one non-woven fabric is gradually changed from 21 mu m to 35 mu m along the pipe wall to the center of the pipe cavity, and the aperture of the other non-woven fabric is gradually changed from 35 mu m to 21 mu m along the pipe wall to the center of the pipe cavity; the carbon fiber can absorb and coat the methylene blue virus better through the change of the local radial flow velocity, and the integral filtering speed is not influenced; meanwhile, part of plasma forms certain roundabout flushing, so that the methylene blue adsorption zone 5 is effectively prevented from being blocked due to protein precipitation, floccule and other deposits.
The plasma methylene blue virus inactivation and filtration device of the invention, the leukocyte removal zone 6 is composed of a plurality of layers of non-woven fabrics with thinner pore diameters, the pore diameters are within 21 mu m, preferably 12 mu m to 21 mu m, and the number of layers is between 2 and 4, so as to filter residual leukocytes in the plasma. In addition, a plurality of layers of non-woven fabrics with superfine pore diameters can be selected as required in the leucocyte removing area 6, so that the leucocyte removing area is reinforced into microorganisms and leucocyte removing areas, and the effects of removing microorganism pollution in plasma are achieved by generally using 1-2 layers of non-woven fabrics with pore diameters smaller than 0.22 mu m and 10-12 layers of non-woven fabrics with pore diameters smaller than 0.65 mu m, so as to intercept bacteria in plasma. Of course, by adding a section of intermediate lumen 2, a microorganism removal zone (not shown) is additionally added at the lower end of the leukocyte removal zone 6.
Preferably, the number of layers of the nonwoven fabric in the leukocyte removal zone 6 is 4, and the pore diameter is gradually decreased from 21 μm, 18 μm, 15 μm to 12 μm in the direction from the inlet to the outlet, so that the amount of the filter medium, the filtration rate and the amount of the blood adsorption loss are simultaneously taken into consideration.
Different from the filtering mode that current platykurtic structure and filter material range upon range of are in the same place from the side infiltration, after adopting tower shower integrated structure, the filter surface diameter can show to reduce, separates filter material non-woven fabrics and carbon fiber, forms independent filtration function region, sets up the lumen of certain space volume in the middle, compares the beneficial effect who obtains with original device and does:
1) The removal rate of methylene blue is effectively improved by about 16%;
2) The loss amount of the plasma is reduced by about 39.6 percent;
3) The effective utilization rate of the material is 4 times that of the existing device, and the filtering performance is stable.
4) The filtering time can be shortened by about 20.1 percent, and the working time of operators is shortened.
5) The anti-blocking capability of plasma filtration is improved, and the influence caused by protein precipitation and floccule precipitation in plasma can be effectively reduced.
6) The side leakage short circuit condition of the existing device can be effectively avoided, and the stability of the filtering performance is ensured.
7) The invention also provides for the addition of a microorganism removal zone to remove microorganisms from the plasma without degrading the filtration performance.
In the embodiment of the invention, the arranged pipe cavity is a cavity with a certain space volume, so that the liquid flowing to the filter layer can completely cover the surface of the filter layer, avoid the liquid from passing through only part of channels due to the inertia of the liquid, and ensure that the filter material is fully utilized; simultaneously, the whole lumen from the inlet to the outlet can smoothly pass through the gas even in the filtering process, so that negative pressure generated by cavitation is avoided, and the bypass exhaust pipeline can be omitted in design when the device is combined with the multi-connected plasma bag. When the inlet pipe cavity 1, the middle pipe cavity 2 and the outlet pipe cavity 3 are all formed by injection molding of hard PVC plastic, the internal pipe cavity structure is shown in figure 1; however, the materials of the lumen used in the present embodiment are not limited to hard PVC plastic, and other suitable materials, such as PP, PC, etc., may be used; meanwhile, the soft medical plastic can be used for manufacturing the soft filter device so as to adapt to integral centrifugation. When medical polypropylene materials, polycarbonate or other hard materials are used for injection molding, UV glue or other suitable binders are used for bonding, and photo-curing treatment is carried out for 5-10 seconds to enhance the bonding firmness.
The embodiment can be used for manufacturing the surgery of the filter device by integral injection molding or split injection molding; when the filter device is separately injection molded, the inner side and the outer side of the edge of each pipe cavity 2 adopt a step structure, so that the filter layer is tightly fixed on the steps at the joint of each pipe cavity in an adhesive mode. The preparation process comprises the following steps:
s1, firstly, injection molding is carried out to form an inlet pipe cavity 1, an outlet pipe cavity 3 and a plurality of sections of middle pipe cavities 2, a step structure is formed outside one end edge of each middle pipe cavity 2, meanwhile, a step structure is formed inside the other end edge, a step structure is formed inside or outside the lower end edge of the inlet pipe cavity 1, and a step structure is formed inside or outside the upper end edge of the outlet pipe cavity 3.
S2, then, superposing and compacting the non-woven fabrics and the carbon fibers, cutting to form a filter layer, and then, mixing tetrahydrofuran and cyclohexanone according to a ratio of 2:1, mixing the materials as an adhesive, and tightly fixing a filter layer on a step at the joint of each lumen;
and S3, finally connecting all the tube cavities together through the adhesive, and forming multiple filtration of a leaching tower type by the plasma pathway from the inlet tube cavity 1, the rough filtration area 4, the middle tube cavity 2, the methylene blue adsorption area 5, the middle tube cavity 2 and the leucocyte removing area 6 to the outlet tube cavity 3.
The space volume of the multi-section middle tube cavity is 100-3000 cubic millimeters, the diameter of each section middle tube cavity 2 is 20-25 mm, the diameters of the inlet end of the inlet tube cavity 1 and the outlet end of the outlet tube cavity 3 are smaller than the diameter of the middle tube cavity 2, and the diameters of the other ends of the inlet tube cavity 1 and the outlet tube cavity 3 are consistent with the diameter of the middle tube cavity 2; the volume of the whole device is greatly reduced, and the total length of each lumen after connection is not more than 6cm, preferably 4 cm-6 cm; so that it can be conveniently connected with the existing blood donation collecting device.
In addition, the inner wall of the middle tube cavity 2 of the embodiment can be provided with a diversion trench (not shown) which spirals forward along the flow direction of the blood plasma; the plasma filtration flow rate near the inner wall of the lumen is generally slower than the flow rate near the center of the lumen, and the characteristics enable the average flow rates of the inner wall of the middle lumen and the center to be consistent, and a certain turbulence effect can be formed, so that the blocking phenomenon can be prevented better. The spiral directions of the diversion trenches on the inner wall of the middle pipe cavity 2 at the two sides of the methylene blue adsorption zone 5 are opposite, so that a certain aggregation effect is played on flocculent precipitate, and the methylene blue virus can be adsorbed better. For the tube cavity adopting the step structure, the diversion trench penetrates through the step, so that the filter layer and the tube cavity are tightly fixed, and the influence on the filtering effect can be well avoided.
In the embodiment, the rough filtration area 4 consists of 1-4 layers of non-woven fabrics with the aperture of more than 70 mu m, and is fixed between the inlet pipe cavity 1 and the middle pipe cavity 2; the methylene blue adsorption zone 5 consists of carbon fibers with the total thickness of 4-12 mm and 1-2 layers of non-woven fabrics with the aperture of 21-35 mu m, wherein the non-woven fabrics are clamped between the carbon fibers or placed at intervals and fixed between two sections of middle tube cavities 2; the leukocyte removing zone 6 is composed of 2-4 layers of non-woven fabrics with the aperture smaller than 21 μm, and is fixed between the outlet lumen 3 and the middle lumen 2, and meanwhile, 1-2 layers of non-woven fabrics with the aperture smaller than 0.22 μm and 10-12 layers of non-woven fabrics with the aperture smaller than 0.65 μm can be selected to be reinforced into a microorganism and leukocyte removing zone (not shown).
The surface of the rough filtering area 4 can be paved after the plasma enters through the inlet pipe cavity 1, and the filtering material is fully utilized; filtering in a rough filtering area 4 to remove the influence of fibrin precipitation and floccule precipitation in the blood plasma; the surface of the methylene blue adsorption zone 5 is paved through the middle pipe cavity 2, and methylene blue is removed through filtration; then the surface of the leukocyte removing zone 6 is fully paved through the middle lumen 2, and the leukocytes are removed by filtration.
The invention adopts the matching scheme of a phi 40mm filter with the minimum filtering area in the prior 200ml methylene blue virus inactivated plasma filtering consumable material on the market and 200ml plasma containing about 3 mu mol/L methylene blue as a filtering solution, and carries out comparative experiments of equivalent filtering to verify the practical utility of the invention. Three examples of diameters phi of 15mm, 20mm and 25mm, respectively, were made to find the most suitable filter size.
Under the same condition, the filter time of the group with the diameter phi of 15mm is prolonged by 8.5 percent compared with the prior device (with the diameter of 40 mm), the filter time of the group with the diameter phi of 20mm is shortened by about 19 percent compared with the prior device, and the filter time of the group with the diameter phi of 25mm is shortened by about 31.8 percent compared with the prior device; from the methylene blue residue, the methylene blue residue of the group with the diameter phi 15mm is increased by about 122.6 percent compared with the prior device, the methylene blue residue of the group with the diameter phi 20mm is reduced by about 18.3 percent compared with the prior device, and the methylene blue residue of the group with the diameter phi 25mm is reduced by about 25.5 percent compared with the prior device; from the plasma loss, the plasma loss was reduced by about 47.9% for the group with diameter phi 15mm compared to the prior art device, by about 37.2% for the group with diameter phi 20mm compared to the prior art device, and by about 14.9% for the group with diameter phi 25mm compared to the prior art device. As the plasma loss is less, the methylene blue residue is low and the filtration time is short, which is the main attention index of virus inactivation plasma filtration, the invention considers that the embodiment with phi of 20mm is superior to the prior device in terms of the plasma loss, the methylene blue residue and the filtration time from the comparison test results of the three design schemes and the prior mature products, and has obvious improvement. While the design with diameter phi 15mm is inferior to the existing device in both filtration time and methylene blue residue, the design with diameter phi 25mm, while optimal in filtration time and methylene blue residue, increases plasma depletion by about 22% compared to diameter phi 20 mm. Thus, in combination with the above factors, a design of 20mm in diameter was determined as an example of optimization. Further verification of material embodiments of diameter phi 20mm was performed, yet with comparison to existing mature devices. The test results prove that compared with the prior device, the filtration time is reduced by 12.90% -27.30%, the methylene blue residue is reduced by 12.90% -19.35%, the plasma loss is reduced by 32.82% -46.37%, and the method is consistent with the previous data, so that the implementation of the diameter phi 20mm is feasible.
The invention experiments the influence of different proportions on the filtering performance according to the embodiment with the diameter phi of 20mm, and determines the optimal proportion according to the experimental result, namely, the rough filtering area 4 consists of 1-4 layers of non-woven fabrics with the aperture of more than 70 mu m, the methylene blue adsorption area 5 consists of carbon fibers with the total thickness of 4-12 mm and 1-2 layers of non-woven fabrics with the aperture of 21-35 mu m, and the leukocyte removing area 6 consists of 2-4 layers of non-woven fabrics with the aperture of less than 21 mu m. The nonwoven fabric with the pore diameter of more than 70 μm selected in the rough filtration area 4 can effectively intercept the fibrin precipitation in the blood plasma, has little influence on the filtration speed, but when the filtration speed reaches 5 layers, the stability of the filtration speed is reduced, and partial liquid is slowly discharged. The invention collects the plasma separated from the obvious fibrin, and evenly mixes and averages the plasma so as to verify the anti-blocking capability of the single-layer non-woven fabrics with different apertures. The experimental result shows that the non-woven fabric with the diameter of 21 mu m has obvious blockage and can not pass under the condition of pressurization; blocking of the nonwoven fabrics of 35 μm and 45 μm also occurred, but plasma was allowed to pass under pressurized conditions; whereas the non-woven fabric of 70 μm does not show clogging. 200ml of non-woven fabric with the thickness of 70 mu m is selected as a fluid, and the influence of the number of non-woven fabric layers on the flow rate is verified. The experimental results show that the flow rate of one to five layers of non-woven fabrics is greatly increased when five layers are used, the time consumption for liquid outflow is long, and the difference is not obvious when one to four layers are used. Therefore, the preferable effect can be obtained when 1 to 4 layers of non-woven fabrics with a thickness of 70 μm or more are used in the rough filtration region.
The non-woven fabrics in the methylene blue adsorption zone 5 play a role in controlling the buffering effect of the flow rate, so that the poor adsorption effect caused by too high flow rate is avoided, but the filtering speed can be greatly influenced by too many layers, and the filtering speed of the non-woven fabrics with more than 3 layers is reduced by about 25%. When the thickness of the carbon fiber is 4mm, the residual quantity of the methylene blue accords with the requirements of related national standards, and when the thickness reaches 12mm, the methylene blue is hardly detected. Therefore, the carbon fiber with the total thickness of 4-12 mm and the non-woven fabric with the aperture of 1-2 layers and 21-35 mu m are selected as the preferable scheme.
The filling of carbon fibers in the middle lumen 2 can further improve the methylene blue adsorption effect, for example, a layer of carbon fibers is added in the embodiment with the diameter of 20mm, and the methylene blue residue is reduced by about 30%.
The non-woven fabrics of the leukocyte removal zone 6 are selected according to experimental data accumulation for years, two layers of non-woven fabrics with the aperture of 21 mu m can meet the requirement of leukocyte removal of blood plasma separated by two units of whole blood, and no leukocyte residue is found according to the results of a leukocyte count experiment carried out by the method according to the 2015 edition of blood transfusion technical operation procedure; and as the number of layers of the non-woven fabric increases, the filtration rate decreases more and more. Comprehensively considering, 2-4 layers of non-woven fabrics with the aperture smaller than 21 mu m are selected.
The invention also verifies that the device can reach the lowest allocation scheme of the current industry standard, namely, the rough filtration area 4 consists of one layer of non-woven fabric with the thickness of 70 mu m, the methylene blue adsorption area 5 consists of two layers of non-woven fabric with the thickness of 21 mu m and the total thickness of 4mm, and the leukocyte removing area 6 consists of two layers of non-woven fabric with the thickness of 17 mu m. The experiment adopts about 220ml of plasma, the concentration of the methylene blue before illumination after adding the methylene blue is about 1 mu mol/L, and the experiment result shows that all performances meet the national relevant standard requirements after the normal illumination inactivation flow.
The embodiment of the invention also analyzes the change of the plasma components before and after filtration, and experimental results show that the recovery rate of main proteins (total proteins, albumin, globulin, protein C and the like) in the plasma before and after filtration is more than 85 percent, the recovery rate of effective coagulation factor activity (such as FVIII, fibrinogen, antithrombin and the like) in the plasma is more than 80 percent, and the method is consistent with the influence of the existing device on the blood components and does not increase the quality influence on the plasma components.
In conclusion, the embodiment of the invention has little influence on main active ingredients in blood plasma, all performances meet the related standard requirements, and compared with the existing filter device, the filter device has obvious advantages in terms of the filtering speed and the filtering loss, meanwhile, the application efficiency of the filter material is greatly improved, on the basis of saving 75% of the filter material, the filtering speed is improved by 20.1%, the methylene blue adsorption performance is improved by 16.1%, the blood plasma loss is reduced by 39.6%, and the defect of insufficient fixation of the filter material by the welding mode of the existing filter device is overcome by the mode of integral bonding assembly.
While the invention has been described with reference to the preferred embodiments, it is not intended to limit the invention thereto, and it is to be understood that other modifications and improvements may be made by those skilled in the art without departing from the spirit and scope of the invention, which is therefore defined by the appended claims.
Claims (9)
1. The plasma methylene blue virus inactivation and filtration device is characterized by comprising an inlet pipe cavity (1), an outlet pipe cavity (3) and a plurality of sections of middle pipe cavities (2), wherein a filter layer is arranged at the joint of two adjacent pipe cavities, a rough filtration area (4), a methylene blue adsorption area (5) and a leucocyte removal area (6) are sequentially formed at the joint of the pipe cavities from the inlet to the outlet;
the inner wall of the middle tube cavity (2) is provided with a diversion trench which spirals forwards along the flowing direction of the blood plasma; the spiral directions of the diversion trenches on the inner wall of the middle pipe cavity (2) at the two sides of the methylene blue adsorption zone (5) are opposite.
2. The plasma methylene blue virus inactivation and filtration device according to claim 1, wherein the rough filtration area (4) is composed of a plurality of layers of non-woven fabrics with larger pore diameters, the pore diameter of the non-woven fabrics is 70 μm-100 μm, and the number of layers is 1-4; the leucocyte removing area (6) is composed of a plurality of layers of non-woven fabrics with finer pore diameters, the pore diameters are 12-21 mu m, and the number of layers is 2-4.
3. The plasma methylene blue virus inactivating filter apparatus according to claim 2, wherein the number of layers of the nonwoven fabric in the leukocyte removal zone (6) is 4, and the pore diameter is 12 μm to 21 μm; the gradient was decreasing from 21 μm, 18 μm, 15 μm to 12 μm in order from the inlet to the outlet.
4. The plasma methylene blue virus inactivating filter apparatus according to claim 2, wherein an intermediate lumen and a filter layer are further provided between the leucocyte removing area (6) and the outlet lumen (3), and the filter layer is composed of 11-14 layers of non-woven fabrics with a pore diameter of 0.65 μm-0.22 μm to form a microorganism removing area.
5. The plasma methylene blue virus inactivation and filtration device according to claim 1, wherein the methylene blue adsorption zone (5) is formed by combining carbon fibers and non-woven fabrics, the total thickness of the carbon fibers is between 4 and 12mm, the pore diameter of the non-woven fabrics is between 21 and 35 μm, and the number of layers is between 1 and 2; the non-woven fabric is sandwiched between or spaced apart from the carbon fibers.
6. The plasma methylene blue virus inactivation filter apparatus according to claim 5, wherein the number of layers of the non-woven fabrics in the methylene blue adsorption area (5) is two, one layer of the non-woven fabrics has pore diameters gradually changed from 21 μm to 35 μm along the pipe wall to the center of the pipe cavity, and the other layer of the non-woven fabrics has pore diameters gradually changed from 35 μm to 21 μm along the pipe wall to the center of the pipe cavity.
7. The plasma methylene blue virus inactivation filter apparatus of claim 1, wherein the spatial volume of the multi-segment intermediate lumen is 100 cubic millimeters to 3000 cubic millimeters.
8. A method of preparing a plasma methylene blue virus inactivation filter apparatus according to any one of claims 1 to 7, comprising the steps of:
s1, firstly, injection molding to form an inlet pipe cavity (1), an outlet pipe cavity (3) and a plurality of sections of intermediate pipe cavities (2), forming a step structure outside one end edge of the intermediate pipe cavity (2), forming a step structure inside the other end edge, forming a step structure inside or outside the lower end edge of the inlet pipe cavity (1), and forming a step structure inside or outside the upper end edge of the outlet pipe cavity (3);
s2, then, superposing and compacting the non-woven fabrics and the carbon fibers, cutting to form a filter layer, and then, mixing tetrahydrofuran and cyclohexanone according to a ratio of 2:1, mixing the materials as an adhesive, and tightly fixing a filter layer on a step at the joint of each lumen;
and S3, finally bonding all the tube cavities together through the adhesive, wherein the central axis of the whole tube cavity from the inlet tube cavity (1) to the outlet tube cavity (3) is a straight line, so that the leaching tower type multiple filtration is formed.
9. The method for preparing the plasma methylene blue virus inactivation filter device according to claim 8, wherein the material of the inlet lumen (1), the outlet lumen (3) and the multi-section middle lumen (2) is soft medical plastic or hard medical plastic, the filter layer is tightly fixed at the joint of the lumens in a gluing way, and the total length of the connected lumens is 4 cm-6 cm; the diameter of the middle tube cavity (2) is 20-25 mm, the diameters of the inlet end of the inlet tube cavity (1) and the outlet end of the outlet tube cavity (3) are smaller than the diameter of the middle tube cavity (2), and the diameters of the other ends of the inlet tube cavity (1) and the outlet tube cavity (3) are consistent with the diameter of the middle tube cavity (2); when the material of the lumen is hard medical plastic, the lumen is bonded by adopting UV glue, and the light curing treatment is carried out for 5-10 s to enhance the bonding firmness.
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| CN2631603Y (en) * | 2003-07-03 | 2004-08-11 | 中国人民解放军军事医学科学院野战输血研究所 | Adsorption filter |
| CN1714292A (en) * | 2002-11-19 | 2005-12-28 | 积水化学工业株式会社 | Plasma or serum separation membrane and filter including plasma or serum separation membrane |
| CN206616221U (en) * | 2017-02-21 | 2017-11-07 | 北京旌准医疗科技有限公司 | A kind of virus filtration adsorbent equipment |
| CN209596610U (en) * | 2019-02-25 | 2019-11-08 | 上海输血技术有限公司 | A kind of blood plasma methylenum careuleum virus inactivating filter device |
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| CN1714292A (en) * | 2002-11-19 | 2005-12-28 | 积水化学工业株式会社 | Plasma or serum separation membrane and filter including plasma or serum separation membrane |
| CN2631603Y (en) * | 2003-07-03 | 2004-08-11 | 中国人民解放军军事医学科学院野战输血研究所 | Adsorption filter |
| CN206616221U (en) * | 2017-02-21 | 2017-11-07 | 北京旌准医疗科技有限公司 | A kind of virus filtration adsorbent equipment |
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