CN109663385A - A kind of blood plasma methylenum careuleum virus inactivating filter device and preparation method thereof - Google Patents
A kind of blood plasma methylenum careuleum virus inactivating filter device and preparation method thereof Download PDFInfo
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Classifications
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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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- Chemical Kinetics & Catalysis (AREA)
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Abstract
The invention discloses a kind of blood plasma methylenum careuleum virus inactivating filter devices and preparation method thereof, including import lumen, the multistage intermediary canal for exporting lumen and having certain space volume, the junction of two neighboring lumen is provided with filter layer, coarse filter area, methylenum careuleum adsorption zone and leucocyte-removing area successively are formed in lumen junction from import to outlet.The present invention separates filtering material non-woven fabrics and carbon fiber to form independent multiple filtering function regions with cavity, the tower multi-filtering of elution can be achieved, so as to effectively improve the utilization efficiency of filtering material, promote the removal rate of methylenum careuleum, reduce the loss of blood plasma, and strainability is stablized, being effectively reduced albumen precipitation and floccule precipitating bring in blood plasma influences.
Description
Technical field
The present invention relates to a kind of medical devices and preparation method thereof more particularly to a kind of blood plasma methylenum careuleum virus inactivating filters
Device and preparation method thereof.
Background technique
Blood-plasma virus killing composition product is the substitute products of blood plasma product, and the purpose is to prevent high risk after plasma infusion
Viral infection.Common methylenum careuleum virus inactivated plasma method in world wide at present, can effectively inactivate lipid envelope in blood plasma
Virus and part non-lipid enveloped virus, such as: the harm that HBV, HCV, HIV health administration department must detect and control
The big virus of property.The effect of methylenum careuleum virus inactivated plasma filter device is, after removal methylenum careuleum photochemical treatment in blood plasma
The methylenum careuleum of remaining, the methylenum careuleum content in methylenum careuleum virus inactivated plasma is reduced as far as possible, thus when large dosage is transfused
Methylenum careuleum exposure minimize；The leucocyte in blood plasma is removed, simultaneously to reduce the generation of the transfusion reactions such as FNHTR.
Filter currently used in the market be it is flat discoid or rectangular, filter material (including non-woven fabrics and carbon fiber) with
Close pressing mode is fixed in filter shell, then keeps filter shell closed in a manner of welding or heat seal.Filter type is side
Face osmosis, i.e. import and outlet are parallel with filtering surface.In practical applications, in order to guarantee effective methylenum careuleum and leucocyte
Removal effect, flat filtering surface is both needed to using biggish diameter, and generally between 40mm~70mm, foreign countries are directed to
The methylenum careuleum virus inactivated plasma of 300ml or more even uses the diameter of 100mm；Cost is not only increased, and is greatly increased
The loss amount of blood plasma.Further, since filter table area is big, it is to be filtered when blood plasma is entered in filtering material from the inlet face of filtering
Liquid usually passes through from easy filtration position, tends not to all and is arrived by infiltration, filtering material to filtering material at the end of filtering
Effective rate of utilization it is low.On the other hand, due to non-woven fabrics and carbon fibre material in filter it is tightly stacked together, centre does not have
Cushion space exists, and is easy in actual use because blocking the problems such as a small amount of fibrin deposition in blood plasma, thus
Affect the effect of filtering, in addition it is serious when lead to not complete filter process.
Summary of the invention
The technical problem to be solved by the present invention is to be directed to plasma volume range in 100ml~500ml, especially to 200ml
With the plasma volume of upper volume, a kind of blood plasma methylenum careuleum virus inactivating filter device and preparation method thereof is provided, can be effectively improved
The utilization rate of filtering material promotes the removal rate of methylenum careuleum, reduces the loss of blood plasma, and strainability is stablized, and is effectively reduced
Albumen is precipitated in blood plasma and floccule precipitating bring influences.
The present invention is to solve above-mentioned technical problem and the technical solution adopted is that provide a kind of blood plasma methylenum careuleum inactivation of virus
Filter device, including import lumen, outlet lumen and multistage intermediary canal, the junction of two neighboring lumen are provided with filtering
Layer successively forms coarse filter area, methylenum careuleum adsorption zone and leucocyte-removing area in lumen junction from import to outlet.
Further, the coarse filter area is made of the biggish non-woven fabrics in multilayer aperture, and non-woven fabrics aperture is in 70 μm~100 μ
M, the number of plies is between 1~4；The leucocyte removal area is made of the thinner non-woven fabrics in multilayer aperture, aperture at 12 μm~21 μm,
The number of plies is between 2~4.
Further, the number of plies of the non-woven fabrics in the leucocyte removal area is 4 floor, 12 μm~21 μm of aperture, from import
To export direction, from 21 μm, 18 μm, 15 μm to 12 μm successively gradient declines.
Further, intermediary canal and filter layer, the mistake are also set up between the leucocyte removal area and outlet lumen
Filtering layer is shaped to microorganism removal area by the non-woven fabrics group in 0.65 μm~0.22 μm of 10~14 floor aperture.
Further, the methylenum careuleum adsorption zone is composed of carbon fiber and non-woven fabrics, and the carbon fiber overall thickness is 4
Between~12mm, the non-woven fabrics aperture is between 21~35 μm, and the number of plies is between 1~2；The non-woven fabrics folder is in the carbon fibers
Between or be spaced apart.
Further, the number of plies of non-woven fabrics is two layers in the methylenum careuleum adsorption zone, and layer of non-woven fabric aperture is arrived along tube wall
Lumen center is gradient to 35 μm by 21 μm, and another layer of non-woven fabric aperture is gradient to 21 μm by 35 μm along tube wall to lumen center.
Further, the spatial volume of the multistage intermediary canal is controlled at 100 cubic millimeters~3000 cubic millimeters.
Further, the intermediary canal inner wall is equipped with along the forward diversion trench of plasma flow direction spiral；The methylene
The spiral opposite direction of diversion trench on blue adsorption zone two sides intermediary canal inner wall.
The technical problems to be solved by the invention also provide a kind of system of above-mentioned blood plasma methylenum careuleum virus inactivating filter device
Preparation Method, wherein include the following steps: that S1, first injection molding form import lumen, export lumen and multistage intermediary canal, and
Form step structure on the outside of one end margin of intermediary canal, while forming step structure on the inside of another end margin, it is described into
It is formed with step structure on the inside or outside of the lower edge of mouth lumen, is formed on the inside or outside of the upper end-face edge of the outlet lumen
There is step structure；S2, then will non-woven fabrics and carbon fiber superposition compress after cutting form filter layer, then by tetrahydrofuran and ring
Hexanone is used as binder by 2:1 mixing, filter layer is tightly fixed on the step of each lumen junction；S3, finally by each pipe
Chamber is bonded together by binder, and the entire lumen central axes from import lumen to outlet lumen are straight line, forms leaching
Wash tower multi-filtering.
Further, the import lumen, outlet lumen and multistage intermediary canal material be soft medical plastic or
Person's hard medical plastic, the filter layer is tightly fixed to the junction of each lumen by adhesive means, after each lumen connection
Total length is 4cm~6cm；The intermediary canal diameter is 20mm~25mm, and the import lumen arrival end and outlet lumen go out
The diameter at mouthful end is less than the diameter of intermediary canal, the diameter and intermediary canal of the import lumen and the outlet lumen other end it is straight
Diameter is consistent；It when lumen material is hard medical plastic, is bonded using UV glue, while carrying out photocuring and handling 5~10s
To enhance the firmness of bonding.
The present invention comparison prior art has following the utility model has the advantages that blood plasma methylenum careuleum virus inactivating filter provided by the invention
Device and preparation method thereof, be different from it is existing by filtering material non-woven fabrics it is tightly stacked with carbon fiber together with the filtering side that permeates
Formula separates filtering material non-woven fabrics and carbon fiber to form independent multiple filtering function regions, each filter element
There is cushion space to store waste, realizes and elute tower multi-filtering, so as to effectively improve the removal rate of methylenum careuleum,
The loss of blood plasma is reduced, and strainability is stablized, effectively improve filter effect, reduces plasma protein precipitation and floccule precipitating
Bring blocking influences.
Detailed description of the invention
Fig. 1 is blood plasma methylenum careuleum virus inactivating filter apparatus structure schematic diagram of the present invention.
Specific embodiment
The invention will be further described with reference to the accompanying drawings and examples.
Fig. 1 is invention blood plasma methylenum careuleum virus inactivating filter apparatus structure schematic diagram.
Referring to Figure 1, blood plasma methylenum careuleum virus inactivating filter device provided by the invention, including import lumen 1, outlet
Chamber 3 and multistage intermediary canal 2, the junction of two neighboring lumen are provided with filter layer, from import to outlet successively in lumen
Junction forms coarse filter area 4, methylenum careuleum adsorption zone 5 and leucocyte-removing area 6.The present invention divides filtering material non-woven fabrics and carbon fiber
Independent filtering function region is opened and formed, coarse filter area 4, methylenum careuleum adsorption zone 5, leucocyte-removing area 6 are divided into；Each region is with multistage
Intermediary canal 2 is connected, and each intraluminal junction is tightly fixed in a manner of gluing etc.；It can be achieved tower multiple in eluting
Filtering.
Blood plasma methylenum careuleum virus inactivating filter device of the invention, the coarse filter area 4 is by the biggish non-woven fabrics in multilayer aperture
Composition, non-woven fabrics aperture is at 70 μm or more, and preferably 70 μm~100 μm, the number of plies tentatively filters out fiber egg in blood plasma between 1~4
White precipitation and floccule precipitating, play the role of anti-clogging.Existing filter type, anti-clogging energy are compared in the presence of coarse filtration layer
Power is obviously improved, and is mainly reflected in that the rate of filtration is fast and relatively stable, and filtration time deviation is smaller, and when shortening filtering
Between, facilitate the working time for shortening operator
Blood plasma methylenum careuleum virus inactivating filter device of the invention, the methylenum careuleum adsorption zone 5 is by carbon fiber and non-woven fabrics
Be composed, wherein carbon fiber overall thickness between 4~12mm, non-woven fabrics aperture between 21~35 μm, the number of plies 1~2 it
Between；Carbon fiber adsorption methylenum careuleum, and non-woven fabrics is clipped among carbon fiber or is spaced apart, and plays certain flow velocity adjustment effect,
To reinforce the adsorption effect of methylenum careuleum.
Preferably, the number of plies of non-woven fabrics is two layers in methylenum careuleum adsorption zone 5, and layer of non-woven fabric aperture is along tube wall into lumen
Centre is gradient to 35 μm by 21 μm, and another layer of non-woven fabric aperture is gradient to 21 μm by 35 μm along tube wall to lumen center；Pass through part
The variation of radial flow speed so that carbon fiber preferably carries out absorption cladding to methylenum careuleum virus, and does not influence integral filter speed；
Part blood plasma forms certain detour and washes away simultaneously, and effectively prevent protein to be precipitated causes methylenum careuleum to be inhaled with the deposition of floccule etc.
Attached area 5 blocks.
Blood plasma methylenum careuleum virus inactivating filter device of the invention, the leucocyte-removing area 6 is by the thinner nothing in multilayer aperture
Woven fabric composition, aperture is within 21 μm, and preferably 12 μm~21 μm, the number of plies is white to filter out the residue in blood plasma between 2~4
Cell.In addition, as needed also the non-woven fabrics in the ultra-fine aperture of multilayer can be selected in leucocyte removal area 6, reinforced as micro- life
Object and leucocyte removal area, generally by 1~2 layer 0.22 μm of aperture < of non-woven fabrics and 10~12 layers 0.65 μm of aperture < of nonwoven
Cloth, it is therefore an objective to intercept the bacterium in blood plasma, achieve the effect that remove microbial contamination in blood plasma.Certainly, by increasing in one section
Between lumen 2,6 lower end of leucocyte removal area additionally increase microorganism removal area's (not shown).
Preferably, the number of plies of the non-woven fabrics in leucocyte removal area 6 is 4 floor, aperture direction from inlet to outlet, from 21 μ
M, 18 μm, 15 μm to 12 μm successively gradient declines, to take into account filter material dosage, the rate of filtration and Blood index loss amount.
Different from existing flat structure and the filtering material filter type stacked together infiltrated from side, use is tower
It takes a shower after integral structure, filtering surface diameter is significantly reduced, and filtering material non-woven fabrics and carbon fiber are separated, and is formed independent
Filtering function region, the lumen of centre setting certain space volume, what is obtained compared with original device has the beneficial effect that
1) removal rate of methylenum careuleum is effectively improved, removal rate improves about 16%；
2) loss amount of blood plasma is reduced, loss amount reduces about 39.6%；
3) material effective rate of utilization is 4 times of existing apparatus, and strainability is stablized.
4) filtration time about 20.1% can be shortened, shorten the working time of operator.
5) plasmapheresis anti-blockage capability is promoted, and can be effectively reduced albumen precipitation and floccule precipitating bring in blood plasma
It influences.
6) it can effectively avoid existing apparatus from there is a situation where side leakage short circuit, ensure that the stabilization of strainability.
7) present invention can also increase a microorganism removal area, remove in blood plasma in the case where not reducing strainability
Microorganism.
In the embodiment of the present invention, because the lumen of setting is the cavity for having certain spatial volume, so that flow direction filtering
Filtering layer surface can be completely covered in the liquid of layer, avoid only passing through from passage portion because of fluid inertia, guarantee made full use of
Filter material material；Even if gas can also pass through the entire lumen for making from import to outlet simultaneously during the filtration process, avoid because
It cavitates and generates negative pressure, when being combined with multi-joint plasma bags, the setting of By-pass vent pipeline can be saved in design.When import lumen 1,
When intermediary canal 2 and outlet lumen 3 are that hard PVC is molded, interior lumen construction is as shown in Figure 1；But this implementation
Lumen material used in example is not limited to hard PVC, other suitable materials, such as PP, PC can also be used；Meanwhile may be used also
Soft filter device is fabricated to using soft medical plastic, to adapt to whole centrifugation.When using medical polypropylene material, poly- carbonic acid
It when ester or other hard materials are molded, is bonded using UV glue or other suitable binders, while carrying out photocuring processing 5
~10s is to enhance the firmness of bonding.
Integral molded plastic or Split injection manufacture filter device surgery can be used in the present embodiment；Filter device fission is molded respectively
When, outside uses step structure in each 2 edge of lumen, so that filter layer is tightly fixed to each lumen junction by adhesive means
Step on.Specific preparation process is as follows:
S1, first injection molding form import lumen 1, outlet lumen 3 and multistage intermediary canal 2, and in the intermediary canal 2 one
Step structure is formed on the outside of end margin, while step structure is formed on the inside of another end margin, the lower end edge of the import lumen 1
It is formed with step structure on the inside or outside of edge, is formed with step structure on the inside or outside of the upper end-face edge of the outlet lumen 3.
S2, then will non-woven fabrics and carbon fiber superposition compress after cutting form filter layer, then by tetrahydrofuran and hexamethylene
Ketone is used as binder by 2:1 mixing, filter layer is tightly fixed on the step of each lumen junction；
S3, finally each lumen linked together by above-mentioned binder, blood plasma approach import lumen 1, coarse filter area 4, in
Between lumen 2, methylenum careuleum adsorption zone 5, intermediary canal 2, leucocyte-removing area 6 to outlet lumen 3, formed and elute tower multiple mistake
Filter.
The spatial volume of the multistage intermediary canal of the present embodiment is 100 cubic millimeters~3000 cubic millimeters, every section of centre
The diameter of lumen 2 is 20mm~25mm, and 1 arrival end of import lumen and the diameter for exporting 3 outlet end of lumen are less than intermediate tube
The diameter of chamber 2, the import lumen 1 and the diameter for exporting 3 other end of lumen are consistent with the diameter of intermediary canal 2；Subtract significantly
The volume of small whole device, the total length after each lumen connection is no more than 6cm, preferably 4cm~6cm；To being convenient to and
Existing acquisition device of donating blood is connected.
In addition, 2 inner wall of intermediary canal of the present embodiment can be also equipped with along the forward diversion trench of plasma flow direction spiral (figure
Do not show)；The plasmapheresis flow velocity for being generally proximal to lumen wall is slower than the flow velocity of lumen center, and features described above makes intermediary canal
Inner wall is consistent with the mean flow rate in center, and can form certain turbulent flow, is better protected from clogging.The methylene
The spiral opposite direction of diversion trench on blue 5 two sides intermediary canal of adsorption zone, 2 inner wall, to play certain gather to flocky precipitate
Hold together effect, preferably to adsorb to methylenum careuleum virus.For the lumen using step structure, diversion trench extends through platform
Rank to not only can guarantee that filter layer and lumen were tightly fastened, but also can preferably avoid influencing filter effect.
In the present embodiment, coarse filter area 4 is made of the non-woven fabrics in 1~4 layer of 70 μm of aperture or more, be fixed on import lumen 1 with
Between intermediary canal 2；Methylenum careuleum adsorption zone 5 by the carbon fiber of 4~12mm of overall thickness and 1~2 layer of 21~35 μm of aperture nonwoven
Cloth composition, non-woven fabrics are clipped between carbon fiber or are spaced apart, be fixed between two sections of intermediary canals 2；Leucocyte-removing area 6 is by 2
Non-woven fabrics composition of~4 layers of aperture less than 21 μm, is fixed between outlet lumen 3 and intermediary canal 2, while can be selected 1~2 layer
The non-woven fabrics and 10~12 layers 0.65 μm of aperture < of non-woven fabrics that 0.22 μm of aperture < are reinforced going for microorganism and leucocyte
Except area's (not shown).
Blood plasma can be paved with 4 surface of coarse filter area after entering by import lumen 1, make full use of filter material；Through 4 mistake of coarse filter area
Filter, removal blood plasma inner fibrin is precipitated and the influence of floccule precipitating；5 table of methylenum careuleum adsorption zone is paved with by intermediary canal 2
Face removes methylenum careuleum through filtering；It is paved with 6 surface of leucocyte-removing area through intermediary canal 2 again, through filtering removing leukocytes.
The present invention filters the φ of minimum filter area in consumptive material using commercially available existing 200ml methylenum careuleum virus inactivated plasma
Blood plasma of the mix proportion scheme and 200ml of 40mm filter containing about 3 μm of ol/L methylenum careuleum carries out equivalent filtering as filtering solution
Comparative experiments is to verify actual utility of the invention.The present invention has made three that diameter phi is respectively 15mm, 20mm and 25mm
Embodiment, to look for most suitably used filter sizes.
It is under equal conditions verified, from filtration time, the filtration time of diameter phi 15mm group compares existing apparatus
(diameter 40mm) extends 8.5%, and the filtration time of diameter phi 20mm group shortens about 19% than existing apparatus, diameter phi 25mm group
Filtration time than existing apparatus shorten about 31.8%；From the point of view of methylenum careuleum residual quantity, the methylenum careuleum of diameter phi 15mm group is remained
Than existing apparatus increase about 122.6%, the methylenum careuleum residual of diameter phi 20mm group reduces about 18.3% than existing apparatus, diameter phi
The methylenum careuleum residual of 25mm group reduces about 25.5% than existing apparatus；From the point of view of blood plasma loss amount, the blood plasma of diameter phi 15mm group
Damage loss amount than existing apparatus reduce about 47.9%, the blood plasma loss amount of diameter phi 20mm group fewer than existing apparatus about 37.2%,
The blood plasma loss amount of φ 25mm group fewer than existing apparatus about 14.9%.Due to when blood plasma loses less, methylenum careuleum residual is low and filtering
Between it is short be that virus inactivated plasma filters be primarily upon index, and from pair of above-mentioned three kinds of design schemes and existing matured product
From the point of view of test result, the present invention assert that the embodiment of φ 20mm is equal on blood plasma loss amount, methylenum careuleum residual and filtration time
Better than existing apparatus, it is significantly improved.And the cases of design of diameter phi 15mm is equal on filtration time and methylenum careuleum residual quantity
It is inferior to existing apparatus, the cases of design of diameter phi 25mm is although upper optimal in filtration time and methylenum careuleum residual, blood plasma loss
Amount will increase about 22% compared with diameter phi 20mm.Therefore, amid all these factors, the design scheme for determining diameter phi 20mm is most
Optimal Example.The material embodiments of diameter phi 20mm are further verified, still uses and is compared with existing maturing appts
Compared with.Test result verifying shows that compared with the prior device filtration time reduces 12.90% -27.30%, and methylenum careuleum residual subtracts
Few 12.90% -19.35%, blood plasma waste reduction 32.82% -46.37% is consistent with data before this, illustrates diameter
The embodiment of φ 20mm is feasible.
The present invention has tested influence of the different ratio to strainability with the embodiment of diameter phi 20mm, and ties according to experiment
Fruit has determined optimal proportion, i.e. coarse filter area 4 is made of the non-woven fabrics in 1~4 layer of 70 μm of aperture or more, and methylenum careuleum adsorption zone 5 is by total
The carbon fiber of 4~12mm of thickness and the non-woven fabrics in 1~2 layer of 21~35 μm of aperture composition, leucocyte-removing area 6 are small by 2~4 floor aperture
It is formed in 21 μm of non-woven fabrics.The non-woven fabrics in 70 μm of the aperture that coarse filter area 4 is selected or more, can effectively intercept the fibre in blood plasma
Fibrillarin is precipitated, and smaller on rate of filtration influence, but when reaching 5 layers, the stability of the rate of filtration declines, under part occurs
The slow situation of liquid.The present invention collects the blood plasma for having obvious fibrin deposition, and mixing is divided equally, to verify the single layer of different pore size
The anti-blockage capability of non-woven fabrics.Experimental result shows, apparent blocking and under an increased pressure still occurs in 21 μm of non-woven fabrics
It can not pass through；Also there is clogging in 35 μm and 45 μm of non-woven fabrics, but blood plasma can pass through under an increased pressure；And 70 μm
Non-woven fabrics do not cause blockages then.It selects 70 μm of the non-woven fabrics of 200ml using blood plasma as liquid, verifies the non-woven fabrics number of plies pair
The influence of flow velocity.Experimental result shows that the flow velocity time-consuming of one to five layers of non-woven fabrics is significantly increased at five layers, liquid flow occurs
The case where taking a long time out, and difference is unobvious in the case of one to four layers.Therefore, coarse filter area selects 1~4 layer 70 μm or more of nothing
It can get preferable effect when woven fabric.
Non-woven fabrics in methylenum careuleum adsorption zone 5 plays the buffer function of coutroi velocity, absorption caused by avoiding flow velocity too fast
It is ineffective, but the number of plies excessively then can significantly influence the rate of filtration, select 3 layers or more of the non-woven fabrics rate of filtration that can reduce
25% or so.And the thickness of carbon fiber, in 4mm, the residual quantity of methylenum careuleum has met the requirement of concerned countries standard, is reaching
When 12mm, methylenum careuleum is almost examined and is not measured.Therefore it selects by the carbon fiber of 4~12mm of overall thickness and 1~2 layer of 21~35 μm of aperture
Non-woven fabrics is preferably.
Carbon fiber is clogged in intermediary canal 2 can further promote methylenum careuleum adsorption effect, such as reality in above-mentioned φ 20mm
It applies and adds in example into one layer of carbon fiber, methylenum careuleum residual reduces 30% or so.
The non-woven fabrics selection in leucocyte-removing area 6 is then according to the experimental data accumulation of many years, the nonwoven in two layers of 21 μm of apertures
Cloth is able to satisfy the blood plasma leucocyte-removing requirement that two unit whole bloods separate, according to 2015 editions blood transfusion regulations for technical operation the methods
The white blood cell count(WBC) experimental result of progress does not find that leucocyte remains；And with the increase of the non-woven fabrics number of plies, filtering rate drop
It is low that amplitude is increasing.Comprehensively consider, selects 2~4 layers of non-woven fabrics of aperture less than 21 μm.
The present invention, which also demonstrates the present apparatus, can reach the minimalist configuration scheme of existing professional standard, i.e., coarse filter area 4 is by one layer
70 μm of non-woven fabrics composition, methylenum careuleum adsorption zone 5 are made of the non-woven fabrics that the carbon fiber of two layers of overall thickness 4mm presss from both sides one layer 21 μm,
Leucocyte-removing area 6 is made of two layers of 17 μm of non-woven fabrics.Experiment uses the blood plasma of about 220ml, after addition methylenum careuleum before illumination
About 1 μm of ol/L of methylenum careuleum concentration carries out filtration test after normal illumination inactivates process, the experimental results showed that properties are full
Sufficient relevant national standard requirement.
The embodiment of the present invention also analyzes the variation of filtering Plasma Before And After ingredient, experimental result display filtering front and back
The rate of recovery effective blood coagulation in 85% or more, blood plasma of major protein (total protein, albumin, globulin, PROTEIN C etc.) in blood plasma
The rate of recovery of factor active (such as FVIII, fibrinogen, antithrombase) 80% or more, with existing apparatus to blood at
The influence divided is consistent, does not increase on the influence of the quality of plasma composition.
In conclusion the embodiment of the present invention is minimum on the main active influence in blood plasma, properties meet phase
Standard requirements are closed, and compared with existing filter device, had a clear superiority in the rate of filtration, filtering waste, while significantly
The application efficiency for improving filtering material, on the basis of saving 75% filtering material, the rate of filtration improves 20.1%, methylene
Blue absorption property improves 16.1%, and blood plasma waste reduces 39.6%, and the mode of whole bonding assembling also makes up now
There is filter device welding manner to the defect of filtering material hypopexy.
Although the present invention is disclosed as above with preferred embodiment, however, it is not to limit the invention, any this field skill
Art personnel, without departing from the spirit and scope of the present invention, when can make a little modification and perfect therefore of the invention protection model
It encloses to work as and subject to the definition of the claims.
Claims (10)
1. a kind of blood plasma methylenum careuleum virus inactivating filter device, which is characterized in that including import lumen (1), outlet lumen (3) with
And multistage intermediary canal (2), the junction of two neighboring lumen are provided with filter layer, successively connect in lumen from import to outlet
Place is formed coarse filter area (4), methylenum careuleum adsorption zone (5) and leucocyte-removing area (6).
2. blood plasma methylenum careuleum virus inactivating filter device as described in claim 1, which is characterized in that the coarse filter area (4) by
The biggish non-woven fabrics composition in multilayer aperture, non-woven fabrics aperture is at 70 μm~100 μm, and the number of plies is between 1~4；The leucocyte is gone
Except area (6) are made of the thinner non-woven fabrics in multilayer aperture, aperture is at 12 μm~21 μm, and the number of plies is between 2~4.
3. blood plasma methylenum careuleum virus inactivating filter device as claimed in claim 2, which is characterized in that the leucocyte removal area
(6) number of plies of the non-woven fabrics in is 4 layers, 12 μm~21 μm of aperture；Direction from inlet to outlet, from 21 μm, 18 μm, 15 μm to 12
μm successively gradient declines.
4. blood plasma methylenum careuleum virus inactivating filter device as claimed in claim 2, which is characterized in that the leucocyte removal area
(6) outlet lumen (3) between also settable intermediary canal and filter layer, the filter layer by 11~14 layers of 0.65 μm of aperture~
0.22 μm of non-woven fabrics group is shaped to microorganism removal area.
5. blood plasma methylenum careuleum virus inactivating filter device as described in claim 1, which is characterized in that the methylenum careuleum adsorption zone
(5) it is composed of carbon fiber and non-woven fabrics, the carbon fiber overall thickness is between 4~12mm, and the non-woven fabrics aperture is 21
Between~35 μm, the number of plies is between 1~2；The non-woven fabrics is clipped among carbon fiber or is spaced apart.
6. blood plasma methylenum careuleum virus inactivating filter device as claimed in claim 5, which is characterized in that the methylenum careuleum adsorption zone
(5) number of plies of non-woven fabrics is two layers in, and layer of non-woven fabric aperture is gradient to 35 μm by 21 μm along tube wall to lumen center, another layer
Non-woven fabrics aperture is gradient to 21 μm by 35 μm along tube wall to lumen center.
7. blood plasma methylenum careuleum virus inactivating filter device as described in claim 1, which is characterized in that the multistage intermediary canal
Spatial volume be 100 cubic millimeters~3000 cubic millimeters.
8. blood plasma methylenum careuleum virus inactivating filter device as described in claim 1, which is characterized in that the intermediary canal (2)
Inner wall is equipped with along the forward diversion trench of plasma flow direction spiral；Methylenum careuleum adsorption zone (5) two sides intermediary canal (2) inner wall
On diversion trench spiral opposite direction.
9. a kind of preparation method of blood plasma methylenum careuleum virus inactivating filter device as described in any one of claims 1 to 8, special
Sign is, includes the following steps:
S1, first injection molding form import lumen (1), outlet lumen (3) and multistage intermediary canal (2), and in the intermediary canal
Step structure is formed on the outside of (2) one end margins, while step structure is formed on the inside of another end margin, the import lumen (1)
Lower edge on the inside or outside of be formed with step structure, be formed on the inside or outside of the upper end-face edge of outlet lumen (3)
Step structure；
S2, then will non-woven fabrics and carbon fiber superposition compress after cutting form filter layer, then tetrahydrofuran and cyclohexanone are pressed
2:1 mixing is used as binder, filter layer is tightly fixed on the step of each lumen junction；
S3, finally each lumen bonded together by above-mentioned binder, from import lumen (1) to the entire of outlet lumen (3)
Lumen central axes are straight line, are formed and elute tower multi-filtering.
10. the preparation method of blood plasma methylenum careuleum virus inactivating filter device as claimed in claim 9, which is characterized in that described
The material of import lumen (1), outlet lumen (3) and multistage intermediary canal (2) is soft medical plastic or hard medical plastic
Material, the filter layer are tightly fixed to the junction of each lumen by adhesive means, the total length after each lumen connection for 4cm~
6cm；Intermediary canal (2) diameter is 20mm~25mm, import lumen (1) arrival end and outlet lumen (3) outlet end
Diameter be less than intermediary canal (2) diameter, the import lumen (1) and outlet lumen (3) other end diameter and intermediate tube
The diameter of chamber (2) is consistent；When lumen material is hard medical plastic, bonded using UV glue, while carrying out photocuring
5~10s is handled to enhance the firmness of bonding.
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| CN201910138157.3A CN109663385B (en) | 2019-02-25 | 2019-02-25 | Plasma methylene blue virus inactivation and filtration device and preparation method thereof |
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| CN201910138157.3A CN109663385B (en) | 2019-02-25 | 2019-02-25 | Plasma methylene blue virus inactivation and filtration device and preparation method thereof |
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Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN111346108A (en) * | 2020-04-28 | 2020-06-30 | 国药集团武汉血液制品有限公司 | Preparation method of virus inactivated plasma for treating COVID-19 |
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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 apparatus including the 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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| Publication number | Priority date | Publication date | Assignee | Title |
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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 apparatus including the 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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