CN102861365B - Leukocyte filter with soft shell and manufacturing method of leukocyte filter - Google Patents
Leukocyte filter with soft shell and manufacturing method of leukocyte filter Download PDFInfo
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- CN102861365B CN102861365B CN201210343078.4A CN201210343078A CN102861365B CN 102861365 B CN102861365 B CN 102861365B CN 201210343078 A CN201210343078 A CN 201210343078A CN 102861365 B CN102861365 B CN 102861365B
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Abstract
The invention discloses a leukocyte filter with a soft shell and a manufacturing method of the leukocyte filter. The leukocyte filter with the soft shell comprises two PVC (Polyvinyl Chloride) external membranes and a filter membrane assembly; the filter membrane assembly is arranged between the two PVC external membranes to form an unfiltered liquid cavity and a filtered liquid cavity; the filter membrane assembly comprises a combined filter membrane as well as two PVC internal membrane rings which are respectively arranged at two sides of the combined filter membranes; the internal edges of the PVC internal membrane rings are in sealed connection with the external edge of the combined filter membrane, and meanwhile, the internal membrane rings are in sealed connection with the edges of the PVC external membranes; the unfiltered liquid cavity is provided with an inlet catheter; and the filtered liquid cavity is provided with an outlet catheter and a support tube. According to the leukocyte filter with the soft shell and the manufacturing method of the leukocyte filter, the soft shell material and the filter membrane are adopted, and the binding site has the characteristics of high fusion strength, good flexibility and strong elasticity; the soft shell material and the filter membrane are capable of resisting high temperature and high pressure without breakage during the steam sterilization, and are not broken during the high-speed centrifugal separation of blood, resulting in leakage; and meanwhile, the leukocyte filter with the soft shell has the advantages of simple and attractive appearance and high utilization rate of materials and is easy to realize mass production.
Description
Technical field
The invention belongs to medical instruments field, particularly relate to the leucocyte filter of safe transfusion.
Background technology
Modern transfusion science research shows, in blood, non-therapeutic composition leukocyte is a kind of " polluter ", can produce leucocyte antibody, cause a series of untoward reaction and side effect after allogenic blood transfusions.Clinical data shows that a certain proportion of blood donor has transfusion reaction in various degree, as: nonhemolytic febrific reaction, Inefficacy of Platelets Transfusion, transfusion-associated graft versus host disease (GVHD), cytomegalovirus (CMV) infects.Therefore, blood and composition removal leukocyte thereof are of great significance to transfusion safety and clinical treatment.
In order to improve transfusion safety, some country's inventions have manufactured various defecator for the leukocyte in filtering blood and composition thereof, and also there are some Patents in our country.As: CN94111296.9 discloses the leucocyte filter of a kind of glass fibre membrane as filter medium, makes by containing alkali ultra-fine fibre glass material; CN200310110360.9 discloses a kind of single use filter for removing white blood cell, it is characterized in that the filter course in leucocyte filtration device is the double-decker that different pore size organic fiber forms, the fibrolaminar maximum diameter of hole of intake chamber side is 45 μm, and the fibrolaminar maximum diameter of hole of liquid outtake chamber side is 25 μm; CN00236855.2 discloses a kind of leucocyte filter, comprise plastics bracket, diaphragm and upper plastic cover, wherein plastics bracket central authorities have liquid outlet, and upper plastic cover has liquid inlet and air vent, and the exit of air vent is provided with hydrophobic membrane, upper plastic cover and plastics bracket are thread connection.The housing majority of these filters is the duricrust filter of ABS, PC moulding.Although duricrust filter is applied in large quantities, when using, there is limitation.General duricrust filter not ability high speed centrifugation, under the effect of high speed centrifugation power, filter housing produces cracking, and filter membrane is damaged, and affects strainability, and the blood bag of hard shell body to surrounding also may cause damage simultaneously.In this case, first to Whole Blood Filtration, afterwards filter heat seal can only be separated after blood sampling, then centrifugalize is carried out to whole blood after filter.Characteristic due to erythrocytic form filter determines this process not only filtering leukocyte, also filters out useful platelet, wastes valuable platelet resource.Some whole blood filter service conditions are harsh, need blood refrigerating could filter for more than 6 hours, just cannot obtain fresh frozen plasma and produce cryoprecipitate.
US Patent No. 20100108596A1, discloses the filter of a kind of two-layer soft pvc film as shell body, but the technological process of not mentioned substep heat seal and filter membrane structure.Domestic have resistance to centrifugal filter patent, as CN200510033270.3 discloses a kind of bag sealed type leukocyte filter, it is characterized in that: the leucocyte filter of duricrust is contained in sealing bag.When put into centrifuge carry out powerful centrifugal time, even if duricrust produce crack, sealing bag still can ensure that leucocyte filter can not be polluted by outside air.This is not real resistance to centrifugal filter obviously.The domestic filter patent also having soft-shell, as: soft blood component filter disclosed in CN200820153904.8, adopt ultrasonic welding process, outward appearance adopts circle, water-drop-shaped, heart, and blood externally permeates in the middle of filter membrane, and middle filter membrane forms filter ante-chamber, two filter back cavity is formed between external filter and housing, although internal structure is unique, the maximum shortcoming membrane filtration efficiency of this structure is relatively low, and production difficulty is larger simultaneously.Soft-shell filter product performance on domestic market is not ideal enough.A kind of leucocyte-removing filter device disclosed in CN200820021399.1, comprise soft structure bag, polyester fiber filter element that plastic sheeting makes, bag side is provided with liquid-inlet, can be centrifugal in Large Copacity centrifuge together with connection bag easily.
The soft-shell filter that CN200820153904.8 and CN200820021399.1 relates to has resistance to centrifugal function, but do not mention filtercondition, and filtercondition on strainability impact greatly, according to the market information collected, domestic filter filter is meeting the blood filtration at 4 DEG C of cold preservation 6-48h, strainability is more satisfactory, but strainability when blood heat is higher does not reach standard-required.
Summary of the invention
For the defect existed in prior art and technical problem, the invention provides a kind of soft shell leucocyte filter and preparation method thereof, it adopts soft sheathing material and filter membrane, the binding site of filter has the advantages that fusion intensity is high, pliability good, retractility is strong, can withstand high temperatures high pressure and not breaking in steam sterilization process, can not rupture in the separation process of blood high speed centrifugation and leak; External form is succinct, attractive in appearance simultaneously, and stock utilization is high.This Structure and energy feature makes easily to realize batch production.
For solving the problems of the technologies described above, the present invention is by the following technical solutions: a kind of soft shell leucocyte filter, comprise two panels PVC adventitia and filter membrane component, this filter membrane component is located between two panels PVC adventitia, thus sap cavity after forming the front sap cavity of filter and filter, described filter membrane component comprises combination filter membrane and is located at zona in the two panels PVC of these combination filter membrane both sides respectively, and in this PVC, the inward flange of zona is connected with the outer fringe seal of combination filter membrane, and this interior zona is connected with the edge seal of PVC adventitia simultaneously; Before described filter, sap cavity is provided with inlet ducts, and after described filter, sap cavity is provided with delivery channel and stay pipe.
As preferably, in described combination filter membrane and PVC, the place of being tightly connected of zona is provided with enhancing anchor point.It is adopt the embedded heat seal of bi-concave that sealing connects, and heat seal EDS maps has enhancing anchor point, and shape can be circular, square or rhombus.Its effect one, can effectively reduce heat seal area under guarantee fusion intensity, avoid excessive heat seal, if excessively heat seal, sealing loci can harden; Its effect two, strengthens anchor point and can make the effective centering of upper and lower heat-seal mould, and Timeliness coverage is eccentric and heat seal is bad.Such as, the not of uniform size of each point causes, and illustrates that heat sealing die has inclination, needs adjustment level; As fruit dot dislocation, illustrate that upper/lower die misaligns, need the centering adjusting upper/lower die.
As preferably, the material of described combination filter membrane is the polyester fiber non-woven fabric of different pore size.
As preferably, described combination filter membrane comprises coarse filtration layer and filter bed of essence, and wherein coarse filtration layer is 1 ~ 4 layer, and every layer thickness is 1.0 ~ 1.5mm, and maximum diameter of hole is 40 ~ 150 μm; Described filter bed of essence is 4 ~ 20 layers, and every layer thickness is 0.5 ~ 1.5mm, and maximum diameter of hole is 15 ~ 25 μm.Its coarse filtration layer and filter bed of essence can according to actual requirement specifications design.
As preferably, in described PVC adventitia and PVC, zona adopts medical grade calendered film or cylinder film.
Another object of the present invention there is provided a kind of preparation method of above-mentioned soft shell leucocyte filter, and it comprises the following steps:
The preparation of a, filter membrane component: successively zona in zona in a slice PVC, combination filter membrane and another sheet PVC is stacked gradually, then by high frequency heat seal by zona in PVC inward flange be connected and sealed with the outer rim of combination filter membrane;
B, periphery heat seal: then successively a slice PVC adventitia, inlet ducts, filter membrane component, stay pipe, delivery channel and another sheet PVC adventitia are carried out stacked, and inlet ducts and delivery channel all in be lined with stainless steel bar, then by high frequency heat seal zona in the PVC in filter membrane component be connected with the edge seal of PVC adventitia and take out stainless steel bar, before making filter, sap cavity is provided with inlet ducts simultaneously, and after filter, sap cavity is then provided with delivery channel and stay pipe.
Beneficial effect: relative to prior art, the present invention has the following advantages: adopt with soft sheathing material and filter membrane, and binding site has the advantages that fusion intensity is high, pliability good, retractility is strong, can withstand high temperatures high pressure and not breaking in steam sterilization process, can not rupture in the separation process of blood high speed centrifugation and leak; External form is succinct, attractive in appearance simultaneously, and stock utilization is high, easily realizes batch production.
Accompanying drawing explanation
Fig. 1 is the structural representation before leucocyte filter of the present invention is tightly connected;
Fig. 2 is that in leucocyte filter of the present invention, in PVC, zona is respectively and PVC adventitia and the structural representation be tightly connected that combines between filter membrane;
Fig. 3 is the structural representation after leucocyte filter of the present invention is tightly connected;
Fig. 4 is structural representation leucocyte filter of the present invention being applied to white blood taking bag.
Wherein, zona 3, combination filter membrane 4, inlet ducts 5, delivery channel 6, stay pipe 7, enhancing anchor point 8 in PVC adventitia 1, filter membrane component 2, PVC.
Detailed description of the invention
Below in conjunction with specific embodiments and the drawings, the present invention is described in further detail.
As shown in Figures 1 to 3, a kind of bladder leucocyte filter, forms primarily of inlet ducts 5, filter membrane component 2, PVC adventitia 1, stay pipe 7, delivery channel 6.Filter membrane component 2 is located between two panels PVC adventitia 1, thus sap cavity sap cavity rear with filter before forming isolated filter.Inlet ducts 5 is communicated with sap cavity before filter, and delivery channel 6 is communicated with sap cavity after filter.Filter membrane component 2 and PVC adventitia 1 shell are all soft materials, distinctive structure and heat seal process, sealing loci is had intensity is high, retractility is strong feature, can withstand high temperatures high pressure and not breaking in steam sterilization process; Sealing loci pliability is good, ensures that it can not rupture in high speed centrifugation separation process and blood leakage occurs.Combination filter membrane 4 is made up of coarse filtration layer, filter bed of essence.Wherein the maximum diameter of hole of coarse filtration layer is 40-150 μm, and the maximum diameter of hole of filter bed of essence is 15-25 μm.Material is polyester fiber nonwoven filter membrane.Concrete combination filter membrane 4 structure can according to the use model of filter, specification and determining.Combination filter membrane 4 has ladder filter effect, and guarantee to filter smooth, filter loss amount is few, filtration 24 DEG C below, and the ratio that leukocyte depletion rate is greater than 99.9% accounts for more than 95%, and the ratio that leukocyte depletion rate is greater than 99.99% accounts for more than 80%.The shape of the external structure of blood filter, large I, according to use model, specification and changing, are convenient to identify.No matter which kind of profile, its heat seal periphery is all arc-shaped transition, be conducive to sterilizing be heated after not crimping, keep the advantage of good looking appearance.
Above-mentioned soft shell leucocyte filter is prepared mainly through two-step method high frequency heat seal technique.
The first step, the heat seal of filter membrane component 2.First in order zona 3 in zona in a slice PVC 3, combination filter membrane 4 and a slice PVC is fixed on lower mould, make combination filter membrane 4 outer rim parallel with the inner rim heat sealed portion of PVC film ring, control time, frequency, electric current and pressure, integral by high frequency heat seal, form filter membrane component 2.This step heat seal adopts relatively high power high frequency heat seal equipment.
Sealing loci structure: the embedded heat seal of bi-concave, heat seal EDS maps has enhancing anchor point 8, and shape can be circular, square or rhombus.Strengthening anchor point actual is on heat-seal mould, produce difform salient point, is formed during heat seal.Its effect one, can effectively reduce heat seal area under guarantee fusion intensity, avoid excessive heat seal, if excessively heat seal, sealing loci can harden; Its effect two, strengthens anchor point 8 and can make the effective centering of upper and lower heat-seal mould, and Timeliness coverage is eccentric and heat seal is bad.Such as, the not of uniform size of each point causes, and illustrates that heat sealing die has inclination, needs adjustment level; As fruit dot dislocation, illustrate that upper/lower die misaligns, need the centering adjusting upper/lower die.
Second step, periphery heat seal.In order a slice PVC adventitia 1, inlet ducts 5, filter membrane component 2, stay pipe 7, delivery channel 6 and a slice PVC adventitia 1 are fixed on mould, wherein two conduit inner liner stainless steel rods, control heat sealed time, frequency, electric current and pressure, thermal synthesis one, stainless steel bar is extracted after heat seal, formation is closed, independently filter front sap cavity and the rear sap cavity of filter, and the front sap cavity of filter is communicated with inlet ducts 5, and after filtering, sap cavity is communicated with delivery channel 6.Form product type, the flow direction, manufacturer make etc. in this heat seal process at periphery simultaneously.This heat seal total amount is relatively little, adopts the heat seal equipment of smaller power.Deburring can be completed with periphery heat seal one step, also can carry out deburring after periphery heat seal.
As shown in Figure 4, above-mentioned soft shell leucocyte filter is used for white blood taking bag system (namely remove leukocyte and retain erythrocyte): the inlet ducts 5 of erythrocytic form soft shell leucocyte filter is connected with blood bag delivery channel 6 before filter, and delivery channel 6 is connected with the inlet ducts 5 of alserver's solution bag.The white blood taking bag that goes that soft shell leucocyte filter and each blood bag connect into stands steam sterilization process.Do not need cold preservation to get final product high speed centrifugation after adopting whole blood, isolate blood plasma and erythrocyte concentrated solution.Again filter is carried out to isolated erythrocyte concentrated solution white: first alserver's solution is poured into erythrocyte concentrated solution, can filter after mixing; Filter proerythrocyte suspension enters the front sap cavity of filter from inlet ducts 5, and enter sap cavity after filter through the filtration of combination filter membrane 4, after filter, blood flows into red cell preservation bag through delivery channel 6, namely obtains and removes leukocytic red cell suspension.The meaning of this structure is: can isolate blood plasma in time for the preparation of fresh frozen plasma, cryoprecipitate and mixing Platelet concentrates, leukocyte simultaneously in online filtering red cell suspension, all operations operates in the system closed, and removes the chance of pollution from, increases transfusion safety.
The strainability of the present embodiment: the about 15-20ml of filter loss amount, filter below 24 DEG C, the ratio that leukocyte depletion rate is greater than 99.9% accounts for more than 95%, and the ratio that leukocyte depletion rate is greater than 99.99% accounts for more than 80%, 100% response rate is greater than 85%, and 90% response rate is greater than 90%.Many batches of filter samples are through ethylene oxide sterilizing, high-temp steam sterilizing, large each flow process of centrifugal force, and casing peripheral is smooth, and filter membrane, PVC film have no damage, and through air-leakage test, none leaks, and demonstrates the unfailing performance of this bladder filter.Meanwhile, this filter adopts combination filter membrane 4 structure, and the filtercondition set point of the filter made is wide, and when 4-24 DEG C, strainability is excellent, and filter smooth, filter loss amount is few, and leukocyte depletion rate is high.
Claims (6)
1. a soft shell leucocyte filter, it is characterized in that: comprise two panels PVC adventitia and filter membrane component, this filter membrane component is located between two panels PVC adventitia, thus sap cavity after forming the front sap cavity of filter and filter, described filter membrane component comprises combination filter membrane and is located at zona in the two panels PVC of these combination filter membrane both sides respectively, in this PVC, the inward flange of zona is connected with the outer fringe seal of combination filter membrane, and this interior zona is connected with the edge seal of PVC adventitia simultaneously; Before described filter, sap cavity is provided with inlet ducts, and after described filter, sap cavity is provided with delivery channel and stay pipe; In described combination filter membrane and PVC, the place of being tightly connected of zona is provided with enhancing anchor point; Described combination filter membrane comprises coarse filtration layer and filter bed of essence, and wherein coarse filtration layer is 1 ~ 4 layer, and every layer thickness is 1.0 ~ 1.5mm, and maximum diameter of hole is 40 ~ 150 μm; Described filter bed of essence is 4 ~ 20 layers, and every layer thickness is 0.5 ~ 1.5mm, and maximum diameter of hole is 15 ~ 25 μm.
2. soft shell leucocyte filter according to claim 1, is characterized in that: the material of described combination filter membrane is the polyester fiber non-woven fabric of different pore size.
3. soft shell leucocyte filter according to claim 1, is characterized in that: in described PVC adventitia and PVC, zona adopts medical grade calendered film or cylinder film.
4. a preparation method for soft shell leucocyte filter described in claim 1, is characterized in that comprising the following steps:
The preparation of a, filter membrane component: successively zona in zona in a slice PVC, combination filter membrane and another sheet PVC is stacked gradually, then by high frequency heat seal by zona in PVC inward flange be connected and sealed with the outer rim of combination filter membrane;
B, periphery heat seal: then successively a slice PVC adventitia, inlet ducts, filter membrane component, stay pipe, delivery channel and another sheet PVC adventitia are carried out stacked, and inlet ducts and delivery channel all in be lined with stainless steel bar, then by high frequency heat seal zona in the PVC in filter membrane component be connected with the edge seal of PVC adventitia and take out stainless steel bar, before making filter, sap cavity is provided with inlet ducts simultaneously, and after filter, sap cavity is then provided with delivery channel and stay pipe.
5. the preparation method of soft shell leucocyte filter according to claim 4, is characterized in that: the punishment that is tightly connected of the heat seal in described PVC between zona and PVC adventitia is furnished with enhancing anchor point.
6. the preparation method of soft shell leucocyte filter according to claim 5, it is characterized in that: the material of described combination filter membrane is polyester fiber non-woven fabric, and it comprises coarse filtration layer and filter bed of essence, and wherein coarse filtration layer is 1 ~ 4 layer, every layer thickness is 1.0 ~ 1.5mm, and maximum diameter of hole is 40 ~ 150 μm; Described filter bed of essence is 4 ~ 20 layers, and every layer thickness is 0.5 ~ 1.5mm, and maximum diameter of hole is 15 ~ 25 μm.
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| CN103341219A (en) * | 2013-07-15 | 2013-10-09 | 中国人民解放军南京军区南京总医院 | Blood collection and transfusion integrated device |
| CN106102790B (en) | 2014-03-10 | 2018-06-08 | 旭化成医疗株式会社 | blood processing filter |
| CN105435320A (en) * | 2015-11-06 | 2016-03-30 | 南京双威生物医学科技有限公司 | Double-layer-membrane soft-shell leucocyte filter and preparation method thereof |
| RU2721494C1 (en) * | 2019-06-14 | 2020-05-19 | Общество с ограниченной ответственностью "ЭСДИАР" | Device for sorption purification of biological fluids |
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| Publication number | Priority date | Publication date | Assignee | Title |
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| CN1729027A (en) * | 2002-12-02 | 2006-02-01 | 旭化成医疗有限公司 | Method of removing leukocytes, leukocyte-removing filter and utilization thereof |
| CN1899631A (en) * | 2006-06-29 | 2007-01-24 | 上海输血技术有限公司 | Soft package blood component filter and its processing process |
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| FR2835752B1 (en) * | 2002-02-13 | 2004-11-26 | Maco Pharma Sa | FILTRATION UNIT COMPRISING CALENDERED DECOOLING LAYERS |
| US7854845B2 (en) * | 2003-09-05 | 2010-12-21 | Hemerus Medical Llc | Biological fluid filtration apparatus |
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| Publication number | Priority date | Publication date | Assignee | Title |
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| CN1729027A (en) * | 2002-12-02 | 2006-02-01 | 旭化成医疗有限公司 | Method of removing leukocytes, leukocyte-removing filter and utilization thereof |
| CN1899631A (en) * | 2006-06-29 | 2007-01-24 | 上海输血技术有限公司 | Soft package blood component filter and its processing process |
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Denomination of invention: Leukocyte filter with soft shell and manufacturing method of leukocyte filter Effective date of registration: 20200615 Granted publication date: 20150304 Pledgee: Bank of China Limited Nanjing Jiangbei New Area Branch Pledgor: NANJING SHUANGWEI BIOTECHNOLOGY Co.,Ltd. Registration number: Y2020980003076 |