CN100490909C - Soft package blood component filter and its processing process - Google Patents

Soft package blood component filter and its processing process Download PDF

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Publication number
CN100490909C
CN100490909C CNB2006100283805A CN200610028380A CN100490909C CN 100490909 C CN100490909 C CN 100490909C CN B2006100283805 A CNB2006100283805 A CN B2006100283805A CN 200610028380 A CN200610028380 A CN 200610028380A CN 100490909 C CN100490909 C CN 100490909C
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blood
soft package
blood component
filter element
filter
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CN1899631A (en
Inventor
李云
钱伟良
许斌
孙健芳
姜跃琴
周惠革
姚蓝
戴勇超
邓明安
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SHANGHAI BLOOD-TRANSFUSION TECHNOLOGY Co Ltd
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SHANGHAI BLOOD-TRANSFUSION TECHNOLOGY Co Ltd
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Abstract

The blood component filter with soft package includes one soft casing, one filter element, one liquid inlet pipe and one liquid outlet pipe. The filter element connected between the liquid inlet pipe and the liquid outlet pipe consists of one or several layers of non-woven fabric and active carbon fiber, and the soft casing is made of medical polymer material. The present invention also discloses the production process and application of the blood component filter with soft package. The blood component filter has no leakage in the periphery of the filter element, can filter out leucocyte, blood fat, virus deactivating medicine and other harmful or unnecessary components from blood effectively.

Description

Soft package blood component filter and processing method thereof
Technical field
The present invention relates to a kind of disposable use medical device product, especially soft package blood component filter and production and processing method thereof, application.
Background technology
Infusion contains leukocytic blood constituent can cause many blood transfusion untoward reaction,, graft versus host disease (GVHD) invalid as nonhemolytic febrific reaction (FNHTR), platelet infusion etc.Simultaneously, leukocyte is still had a liking for the carrier of leukocyte virus, as cytomegalovirus (MCV), human T-lymphocyte leukemia virus, (HTLV-I/II) and human defective immunity virus (HIV), blood transfusion may cause these viruses to be propagated and the activation of latent virus through blood.Adopting the leukocyte in the special-purpose filter filtering of leucocyte-removing blood/blood constituent, is simple and effective, the most the most frequently used so far method.Gong Ying leucocyte-removing blood/blood constituent filter in the market, all in the cabinet that employing hard ABS, macromolecular materials such as PVC, PC are made, defecator is made of inlet tube 14, shell 11, filtering material 12, lid 13 and outlet 15, and ultrasonic bonding or the adherent method of binding agent are adopted in the processing of filter element.It is reported, the blood component filter of above-mentioned traditional structure can be eliminated the leukocyte more than 99%, its appearance profile is generally positive circle, there is concavo-convex character pattern on the surface, as trade mark, manufacturer's sign, specifications and models, import and export etc., its overall dimensions generally is diameter 40~100mm, thickness is between 6~25nm, the defecator of this spline structure, with a whole set of plastic blood bag place, in the process of cryopreservation, can the infringement plastic blood bag, can not carry out more that low-temperature and high-speed is centrifugal to come separating blood constituents with plastic blood bag.
And at present domestic multi-joint bag leucocyte-removing filter is after integral body adopts sterilization, can not reach relevant national standard to the filter effect of the fresh blood gathered the same day and require (residue leukocyte count<2.5 * 10 6/ 1 unit).In order to reach the leucocyte-removing effect, must reduce the temperature to below 10 ℃ or gather the back during filtration places more than the 3h in 2~8 ℃ of refrigerators, this concerning the client prepares fresh frozen plasma (requiring freezing in 6~8 hours after blood sampling) it is pressed for time, for this reason, if can be during use earlier through centrifugal, carry out leucocyte-removing again and filter behind preparation FFP, the two all can be protected then to prepare fresh frozen plasma and leucocyte-removing effect.
But present domestic traditional leucocyte-removing filter device, the shell of its hard, it is centrifugal to be not suitable for any kind of, thus have only adopt whole blood to filter (having lost platelet) after separating blood constituents or behind the centrifugal preparation blood constituent with red cell suspension with the sterile catheter adapter with carry out the leucocyte-removing filtration again after the leucocyte-removing filter is connected.In addition, because just being in full swing rapidly at home of leucocyte-removing and blood-plasma virus killing project comes filtering whole blood as still adopting traditional hard filter, then blood plasma needs to filter through 2 times behind the inactivation of virus, causes in the blood plasma various protein contents low excessively.
Only French abroad at present marcopharma company's production (name is called soft shell filter), it is centrifugal to adapt to various model centrifuges, can carry out various blood constituent filtering removing leukocytes again behind the centrifugal preparation blood constituent earlier to whole blood, filter back residue leukocyte count is conform European standard (≤1.0 * 10 according to the literature 6/ 400ml), but its filter back erythrocyte response rate is low, loses blood volume in the filter element〉35mL/200mL, only about 80%.
And U.S. Pall company is at the centrifugal demand that refilters of customer requirement elder generation, centrifuge is transformed, increase special racks and place the leucocyte-removing filter element, in order to avoid the filter element shell damages plastic blood bag when centrifugal, the client is when using its product, must transform according to the requirement purchase centrifuge of the said firm or to centrifuge, increase the special racks of placing the leucocyte-removing filter element, cause many inconvenience.
Summary of the invention
Main purpose of the present invention is to solve deficiency of the prior art, a kind of leukocyte removal efficiency height, the requirement of blood constituent response rate conformance with standard are provided and can be used for centrifugal soft package blood component filter and production method thereof, the present invention also provide several relatively suitable, the multi-joint bag constructions example of the plastics of soft package blood component filter in this patent is installed, can be for hospital, blood station at different levels, Blood Transfusion Services's use.
For realizing above purpose, this utility model is achieved through the following technical solutions:
Soft package blood component filter, comprise soft housing, filter element, feed tube, drain pipe, the filter element two ends are connected with feed tube and drain pipe respectively, filter element is made up of one or more layers non-woven fabrics and activated carbon fiber, described non-woven fabrics is identical with hull shape, described filter element thickness is greater than the feed tube diameter, and filter element is sealed in the housing, and described housing is that soft medical macromolecular materials are made.
Wherein, described drain pipe is threeway.Described threeway has slit 52, and slit 52 is between threeway import 51,53.
Wherein, described housing is that soft medical PVC material film is made.
Wherein, the soft medical PVC film thickness of described case material is at 0.4~0.8mm, stretcher strain rate<10%.
Wherein, described filter element is made up of two-layer above non-woven fabrics and activated carbon fiber, accompanies activated carbon fiber between every two-layer nonwoven, and the edge of multi-layer nonwoven fabrics merges, edge 42 after multi-layer nonwoven fabrics merges in the filter element and inboard 43 driving fits of housing.
Wherein, described non-woven fabrics aperture is 10~25 μ m; Thickness is 0.5mm~8mm.
Wherein, described activated carbon fiber thickness is 0.4mm~2mm.
Wherein, described non-woven fabrics and activated carbon fiber are biocompatibility.
Wherein, between feed tube and the drain pipe exhaust manifolds are installed, flow-stopping clip or unidirectional blocking vessel are installed on the described exhaust manifolds.
A kind of method of producing soft package blood component filter may further comprise the steps:
PVC thin film and non-woven fabrics and activated carbon fiber are cut into suitable shape;
Multi-layer nonwoven fabrics and activated carbon fiber edge are merged, make filter element;
The filter element middle part is slightly bonding;
Feed tube and drain pipe are connected the filter element two ends;
Fused edge 42 parts and the housing inboard 43 of filter element are fused into one;
Filter element after the edge fusion is sealed in the housing, and housing covers the part of drain pipe and feed tube.
Wherein, by ultrasound wave or ultrasound method the multi-layer nonwoven fabrics edge is converted into after the molten condition bondingly, the edge thickness after bonding is 0.1mm~0.6mm.
Wherein, use high frequency or high-frequency mode that filter element is sealed in the housing; Use ultrasound wave, ultrasound, high frequency, high-frequency mode with feed tube, drain pipe and filter element and housing driving fit.
The blood collection device of soft package blood component filter is installed, comprise blood taking bag, reservoir bag, it is characterized in that, between described reservoir bag and the blood taking bag exhaust manifolds are installed, have been installed in parallel described soft package blood component filter with exhaust manifolds between blood taking bag and the reservoir bag.
Foregoing soft package blood component filter mixes the application in blood such as platelet and the blood products in processing whole blood, blood plasma, red cell suspension, Red Blood Cells Concentrate, Platelets Pheresis/Apheresis platelets, manual many person-portions.
The described blood collection device that soft package blood component filter is installed can be used for processing blood and blood products such as whole blood, blood plasma, red cell suspension, Red Blood Cells Concentrate, Platelets Pheresis/Apheresis platelets, manual many person-portion mixing platelet.
Can be on the market professional nonwoven production of described non-woven fabrics and activated carbon fiber producer buys, handle on the method work surface that it is suitable that described non-woven fabrics can pass through γ irradiation grafting, chemical graft, plasma or face coat processing etc., improves the biocompatibility and the selection adsorptivity to blood/blood component of filtering material.The charcoal granule of described activated carbon fiber meets beautiful ANS/AWWA
B6406-90 standard, product meet beautiful ANSI/NSF42/53 requirement, and the methylene blue absorption amount is pressed the GB7702.6 detection should be between 10~100mg/g, and thickness is 0.4mm~2mm.Wherein, soft medical PVC film can be processed or outsourcing voluntarily with blow moulding equipment, but its macromolecule pellet should meet the requirement of GB15593-1995, and the wrapping film material cytotoxicity after the blowing should be not more than 2 grades, no Intradermal to stimulate and skin allergy.Can there be strip or latticed decorative pattern in soft medical PVC film surface to prevent inside and outside adhesion behind the high pressure steam sterilization.The thickness of soft medical PVC film is between 40~200um, and PVC content is answered〉90%, should be able to bear and be refrigerated to-80 ℃ low temperature environment, and store 24h, immerse subsequently
60min in the water-bath of (37 ± 2) ℃, and then return to room temperature, still can satisfy every instructions for use.
Through experiment, the soft package blood component filter among the present invention can keep not having leakage in two minutes under the 50Kpa compressed air.Under 115~121 ℃, high pressure steam sterilization 30 minutes does not all have adhesion inside and outside the device of sterilization back, does not have distortion, does not have and leak.
The blood component filter that defecator production technology provided by the invention is produced, can stop blood constituent occurs in the filter material edge in filter process side leakage fully, thereby effectively the leukocyte in filtering blood/blood constituent, blood fat, viral inactivating agents etc. are harmful to or unwanted composition, make filtering efficient height, effective ingredient composition loss amount is few, function admirable.
Use soft package blood component filter of the present invention, can be centrifugal with the multi-joint bag system of the plastics at its place, thus can prepare more kinds of blood products, mode of operation is various, uses convenient.
Soft package blood component filter beneficial effect described in the utility model is:
1. the multi-layer nonwoven fabrics edge combines together, the side leakage phenomenon that can avoid blood to produce between filtering material edge and hard filter housing fully.Because filter element and housing almost completely fuse and be one, sealing property is good, and side leakage partly appears in the contact surface that can effectively stop housing and filtering material, thereby has improved leukocyte removal efficiency.
Can with the multi-joint bag of a whole set of plastics stand under any condition centrifugal, realized after the centrifugal blood of gathering is prepared FFP and manual platelet, again cold red cell suspension is carried out the leucocyte-removing operation, both guaranteed FFP quality, prepared manual platelet, remove the leukocyte in the red cell suspension again, met market demands more.
3. leukocyte removal efficiency is greater than 99.9% in the blood constituent after filtering, and the blood constituent response rate is greater than 85%.
4. the soft package blood component filter among the present invention can fit together with blood sampling, blood component preparation and blood-plasma virus killing apparatus, and can not influence other operations.Real blood collection, the composition realized prepares integrated.
5. the present invention of exhaust manifolds has been installed, can have discharged the air in the reservoir bag in filter process or after filtering end, improved the leukocytic response rate.
Description of drawings
Fig. 1 is soft package blood component filter of the prior art (rigid package) structural representation;
The soft package blood component filter processing sketch map that Fig. 2 designs for this patent;
Fig. 3 is the right pseudosection of Fig. 2;
Fig. 4 is the profile of drain pipe;
Fig. 5 is the soft package blood component filter that exhaust manifolds are installed;
Fig. 6 is the blood-taking device structural representation that soft package blood component filter is installed.
Fig. 7 is the first application example sketch map of soft package blood component filter of the present invention;
Fig. 8 is the second application example sketch map of soft package blood component filter of the present invention.
The specific embodiment
The present invention will be further described below in conjunction with accompanying drawing:
Referring to Fig. 2, Fig. 3, Fig. 4, soft package blood component filter, comprise feed tube 1, filter element 4, drain pipe 5 is threeways, housing 7 is made for soft medical PVC material or macromolecule material film, filter element 4 is made up of multi-layer nonwoven fabrics 41 and carbon fiber 44, described non-woven fabrics 41 apertures are 10~25um, gross thickness is 0.5mm~8mm, non-woven fabrics 41 passes through irradiation grafting, chemical graft, suitable method such as plasma or face coat is done surface treatment, improve the biocompatibility of filtering material to blood/blood constituent, the gross thickness of filter element 4 is greater than the diameter of feed tube 1.At first non-woven fabrics 41 is cut into the shape same with housing 7, accompany activated carbon fiber 44 between every two-layer nonwoven 41, combine together after using ultrasound, ultrasound wave or other proper method that multi-layer nonwoven fabrics 41 edges 42 are treated to molten condition, edge 42 thickness are 0.1~0.6mm;
Drain pipe 5 is threeway, has import 51,53, and slit 52 is between import 51,53; Feed tube 1, drain pipe 5 link to each other with filter element 4 by ultrasound wave, ultrasound, high frequency, high frequency or other suitable methods, the edge 42 of filter element 4 embeds in the slit 52, can make blood flow into drain pipe outlet 54 from import 51,53 through filter element 4, use high frequency, high frequency mode with non-woven fabrics edge 42 and shell rim 43 driving fits, non-woven fabrics 41 is sealed in the housing 7, part with feed tube 1, drain pipe 5 is sealed in the housing 7 simultaneously, in case hemostasis liquid seepage.
Referring to Fig. 5, exhaust manifolds 3 two ends communicate with feed tube 1, drain pipe 5 respectively, and flow-stopping clip or unidirectional blocking vessel 2 are installed on the exhaust manifolds 3.
During use, utilize blood deadweight to make blood enter into the middle part of filter element 4, filter, after absorption removes leukocyte, ooze out blood reservoir bag 8 after drain pipe 5 enters filter from two sides of filter element 4 through filter element 4 from feed tube 1.
Foregoing soft package blood component filter can be applicable to process blood and blood products such as whole blood, blood plasma, red cell suspension, Red Blood Cells Concentrate, Platelets Pheresis/Apheresis platelets, manual many person-portion mixing platelet.
Referring to Fig. 6, the blood collection device of soft package blood component filter is installed, comprise blood taking bag 6, blood reservoir bag 8, conduit 9 two ends communicate with blood taking bag 6 and feed tube 1 respectively, and conduit 10 two ends communicate with drain pipe 5 and blood reservoir bag 8 respectively.
During use, blood in the blood taking bag 6 is input to filter element 4 through conduit 9, feed tube 1, after filtering, be input in the blood reservoir bag 8 from drain pipe 5, conduit 10, air in the blood reservoir bag 8 can be discharged by exhaust manifolds 3, flow-stopping clip or unidirectional blocking vessel 2 are used to control the switching of exhaust manifolds 3.
The described blood collection device that soft package blood component filter is installed can be used for processing blood and blood products such as whole blood, blood plasma, red cell suspension, Red Blood Cells Concentrate, Platelets Pheresis/Apheresis platelets, manual many person-portion mixing platelet.
Referring to first application example of Fig. 7 for soft package blood component filter of the present invention, based on the blood collection device that soft package blood component filter is installed shown in Figure 6, transfering bag 16,17,18 is in parallel with blood reservoir bag 8 by conduit.
Referring to second application example of Fig. 8 for soft package blood component filter of the present invention, the difference of itself and first application example is, between reservoir bag 8 and transfering bag 16, be parallel with irradiation bag 20, reservoir bag 8 and irradiation bag 20 are communicated with by conduit, virus inactivating agent adding set 19 is installed on the conduit, be used to blood plasma to add viral inactivating agents (as methylene blue etc.), irradiation bag 20 is communicated with transfering bag 16 by conduit, between irradiation bag 20 and transfering bag 16, absorption of flexible package viral inactivating agents and leucocyte filtration device 21 are installed, are used for adsorbing the leukocyte more than the virus inactivating agent and 99.9% of blood plasma more than 85% after the illumination.And soft package blood defecator 4 is used for the leukocyte of the red cell suspension after filtering prepares.Transfering bag 17,18 is in parallel with reservoir bag 8.
The foregoing description only is used for that the present invention will be described, does not constitute the restriction to the claim scope, and other alternative means that it may occur to persons skilled in the art that are all in claim scope of the present invention.

Claims (16)

1. soft package blood component filter, comprise soft housing, filter element, feed tube, drain pipe, it is characterized in that, the filter element two ends are connected with feed tube and drain pipe respectively, filter element is made up of one or more layers non-woven fabrics and activated carbon fiber, described non-woven fabrics is identical with hull shape, described filter element thickness is greater than the feed tube diameter, filter element is sealed in the housing, described housing is that soft medical macromolecular materials are made, described drain pipe is threeway, and described threeway has slit (52), and slit (52) is positioned between the threeway import (51,53).
2. soft package blood component filter according to claim 1 is characterized in that, described housing is that soft medical PVC material film is made.
3. soft package blood component filter according to claim 2 is characterized in that, the soft medical PVC film thickness of described case material is at 0.4~0.8mm, stretcher strain rate<10%.
4. soft package blood component filter according to claim 1, it is characterized in that, described filter element is made up of two-layer above non-woven fabrics and activated carbon fiber, accompany activated carbon fiber between every two-layer nonwoven, the edge of multi-layer nonwoven fabrics merges, edge (42) and housing inboard (43) driving fit after multi-layer nonwoven fabrics merges in the filter element.
5. according to claim 1 or 4 described soft package blood component filters, it is characterized in that described non-woven fabrics aperture is 10~25 μ m, thickness is 0.5mm~8mm.
6. according to claim 1 or 4 described soft package blood component filters, it is characterized in that described activated carbon fiber thickness is 0.4mm~2mm.
7. soft package blood component filter according to claim 1 is characterized in that described non-woven fabrics and activated carbon fiber are biocompatibility.
8. according to claim 1 to 4, the described soft package blood component filter of 7 arbitrary claim, it is characterized in that, between feed tube and the drain pipe exhaust manifolds are installed, flow-stopping clip or unidirectional blocking vessel are installed on the described exhaust manifolds.
9. soft package blood component filter according to claim 5 is characterized in that, between feed tube and the drain pipe exhaust manifolds is installed, and flow-stopping clip or unidirectional blocking vessel are installed on the described exhaust manifolds.
10. soft package blood component filter according to claim 6 is characterized in that, between feed tube and the drain pipe exhaust manifolds is installed, and flow-stopping clip or unidirectional blocking vessel are installed on the described exhaust manifolds.
11. a method of producing soft package blood component filter is characterized in that, may further comprise the steps:
PVC thin film and non-woven fabrics and activated carbon fiber are cut into suitable shape;
Multi-layer nonwoven fabrics and activated carbon fiber edge are merged, make filter element;
The filter element middle part is slightly bonding;
Feed tube and drain pipe are connected the filter element two ends;
Fused edge (42) part of filter element is fused into one with housing inboard (43);
Filter element after the edge fusion is sealed in the housing, and housing covers the part of drain pipe and feed tube.
12. the method for production soft package blood component filter according to claim 11 is characterized in that, by ultrasound wave or ultrasound method the multi-layer nonwoven fabrics edge is converted into after the molten condition bondingly, the edge thickness after bonding is 0.1mm~0.6mm.
13. the method for production soft package blood component filter according to claim 11 is characterized in that, uses high frequency or high-frequency mode that filter element is sealed in the housing; Use ultrasound wave, ultrasound, high frequency, high-frequency mode with feed tube, drain pipe and filter element and housing driving fit.
14. the blood collection device of soft package blood component filter is installed, comprise blood taking bag, reservoir bag, it is characterized in that, between described reservoir bag and the blood taking bag exhaust manifolds are installed, are installed in parallel the described soft package blood component filter of requirement 1-10 arbitrary claim of having the right with exhaust manifolds between blood taking bag and the reservoir bag.
15. the application of the described soft package blood component filter of the arbitrary claim of claim 1-10, it is characterized in that described soft package blood component filter mixes the application in blood such as platelet and the blood products in processing whole blood, blood plasma, red cell suspension, Red Blood Cells Concentrate, Platelets Pheresis/Apheresis platelets, manual many person-portions.
16. the described application that the blood collection device of soft package blood component filter is installed of claim 14, it is characterized in that the described blood collection device that soft package blood component filter is installed mixes the application in blood such as platelet and the blood products in processing whole blood, blood plasma, red cell suspension, Red Blood Cells Concentrate, Platelets Pheresis/Apheresis platelets, manual many person-portions.
CNB2006100283805A 2006-06-29 2006-06-29 Soft package blood component filter and its processing process Active CN100490909C (en)

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Application Number Priority Date Filing Date Title
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CN100490909C true CN100490909C (en) 2009-05-27

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Publication number Priority date Publication date Assignee Title
CN102626544B (en) * 2012-04-27 2014-08-20 北京久久神龙消防器材有限公司 Efficient simple fire extinguisher
CN102861365B (en) * 2012-09-14 2015-03-04 南京双威生物医学科技有限公司 Leukocyte filter with soft shell and manufacturing method of leukocyte filter
CN106110750B (en) * 2016-08-15 2018-10-16 鲁绍荣 A kind of efficient blood recovery system

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