CN103191016B - The soft bag of separation of blood plasma DNA purity is improved when a kind of blood is continuously separated - Google Patents
The soft bag of separation of blood plasma DNA purity is improved when a kind of blood is continuously separated Download PDFInfo
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Abstract
The present invention relates to the soft bag of separation improving blood plasma DNA purity when a kind of blood is continuously separated, blood continuous centrifugal is separated in curved body container and carries out, separation lacuna is provided with in this curved body container, this separation lacuna is a curved body structure, be provided with one in it and be separated soft bag, the pipeline that the soft bag of this separation comprises bag and is attached thereto, a long limit of this bag is provided with blood plasma mouth, blood inlet and blood cell mouth, and the position near blood plasma mouth between blood inlet and blood plasma mouth is provided with a retention device.The soft bag of separation of the present invention has the feature improving blood plasma DNA purity in blood continuous centrifugal is separated.
Description
Technical field
The present invention relates to blood separation technology, be particularly applied to the soft bag of separation on blood continuous centrifugal separation equipment.
Background technology
No matter scientific research or medical clinical practice or commercial production, and more occasion, all need blood separation, as gone out single component from separation of whole blood, usual use centrifuging isolates various single component from blood, for occasions such as clinical treatment, scientific research or raw materials.Modal is that whole blood is isolated erythrocyte, granulocyte, mononuclear cell, platelet and blood plasma by centrifugal separation system, maybe erythrocyte and cleaning mixture is isolated in the FRC washing after thawing.
The operation principle of continuous centrifugal separation system is: the primary structure of said system includes centrifuge, infusion pump and control device; Blood introduced in the soft bag on centrifuge in knock-out drum by the infusion pipeline that is connected with infusion pump, high speed rotating knock-out drum, and drive this soft bag synchronous high-speed to rotate, the not same-action that blood in it is subject to centrifugal force field causes the visible component such as blood plasma and blood cell to do centrifugal sedimentation campaign, and presses the size layering of respective density or proportion or sedimentation coefficient; When reaching sedimentation equilibrium, being arranged each single component layer forming concentric circles from the periphery of radial direction to axle center by the high to Low enrichment of density, then utilizing infusion pump to be extracted by the single component layer of separation again.
It is the effect providing rotary power by airtight flexible pipe and play input continuously and extract out that blood single component realizes continuous acquisition within the system, one end of flexible pipe is communicated with the soft bag that is separated in knock-out drum, with knock-out drum high-speed rotation, the other end of flexible pipe is fixed on support, therefore, rotation one end, flexible pipe one end is fixed, coil arrangement is had in the middle of it to twine to realize flexible pipe solution of untwisting, make whole blood to be inputed in the knock-out drum of rotation under rotation status, and extract the single component such as blood plasma and blood cell out in the knock-out drum rotated.Knock-out drum, i.e. separator disk, combine with coil arrangement and achieve blood continuous centrifugal and be separated.
Relate in prior art be applied to separator disk on blood continuous centrifugal separation equipment and coil arrangement mainly contain US Patent No. 5360542.In that patent, separator disk be one columnar structured, be called knock-out drum, have a columnar lacuna in it, soft bag is placed on the centrifugalize realizing blood in circular lacuna; Coil arrangement includes underframe, rotatable top-support, top-support suspends knock-out drum in midair, originates in bottom knock-out drum a flexible pipe is secured across two bearings of top-support side from cabinet place after, the end of its flexible pipe is a square spigot, originates in the square groove of knock-out drum central axis.Flexible pipe is hollow structure, has several transfer pipeline in it, and realize power provides and Liquid transfer function simultaneously.Based on above-mentioned structure, power makes top-support rotate, and drives flexible pipe untwist and produce torque forces, and is made it by this power transmission to knock-out drum to produce rotating in same direction, and then realizes the separation process of blood continuous centrifugal.
The separator disk of another version is disclosed in Chinese patent application 200710046991.7.Point out in this patent: the separator disk in many cells composition mixing material piece-rate system, comprise durable hard-caked sediment dish and disposable soft bag, the circular discs that hard-caked sediment dish is made up of inner core and base, formed between inner core and base one section around this hard-caked sediment dish circle core shaft one week and the continuous lacuna do not closed of stem and afterbody, soft bag is for being provided with the single cavity structure of liquid inlet and outlet pipe, and this soft bag can be inserted in described lacuna.Because centrifugal force everywhere in described continuous lacuna is inconsistent, therefore under centrifugal force continuous action, each composition of mixing material in segmentation distribution, can extract corresponding single component in soft bag in above-mentioned segmentation.Above-mentioned inner core is equivalent to described interior cylinder, base is equivalent to described outer cylinder.Above-mentioned hard-caked sediment dish that is to say separator disk.
No matter be foreign patent or domestic patent, all have employed the mode that separator disk adds soft bag, soft bag is disposable consumable component part.The separator disk of these the two kinds of forms mentality of designing in actual use due to blood separation is different, and the former be concentric design, and the latter designs for non-concentric, and the separation efficiency of the latter improves a lot compared with the former.Though the latter is comparatively ingenious with the design being separated soft bag at hard-caked sediment dish, and has certain effect in practice, but still has the leeway of Curve guide impeller.
Summary of the invention
The object of the present invention is to provide a kind of soft bag of separation improving blood plasma DNA purity when being separated for blood continuous centrifugal.Being applied on curved body separator disk of this separation bag can realize, total enclosing, safety, high-quality, high efficiency sampled plasma.
In order to reach foregoing invention object, technical scheme provided by the invention is as follows:
The soft bag of separation of blood plasma DNA purity is improved when a kind of blood continuous centrifugal is separated, it is characterized in that, blood continuous centrifugal is separated in curved body container and carries out, separation lacuna is provided with in described curved body container, described separation lacuna is the curved body including outer wall and inwall, and the outer wall curved surface of this separation lacuna is as follows with polar coordinate representation perpendicular to the curve that the plane of rotating shaft projects:
Wherein, polar limit O is the intersection point of rotating shaft and described plane, and polar pole axis L is the ray that limit arrives curve initiating terminal direction, the positive direction of polar angle is clockwise, r is the footpath, pole of any point on curve, and R is the footpath, pole of curve distalmost end, θ
1for the polar angle of curve initiating terminal, its value is 0 degree of this polar coordinate system, θ
2for curve and blood plasma separating factor critical radius F
rthe polar angle of intersection point, blood plasma separating factor critical radius F
rfor blood plasma in unit interval when rotating speed is determined is separated required minimum centrifugal radius, θ
3be a polar angle, its value is θ
21.5 ~ 3.5 times, θ
4for the polar angle of curve distalmost end; In described separation lacuna, [θ
1, θ
2) be blood plasma district, [θ
2, θ
3) be chaotic region, [θ
3, θ
4] be blood cell district, b
1for the curve coefficients in blood plasma district, b
2for the curve coefficients of chaotic region, b
3for the curve coefficients in blood cell district.Be provided with one in described separation lacuna and be separated soft bag, the soft bag of described separation comprises bag and is connected to the pipeline on bag, this bag is rectangle, the long limit of one is respectively arranged with the plasma tube inside and outside connection, whole blood pipeline and blood cell pipeline, described plasma tube initiating terminal is positioned at the blood plasma mouth of bag minor face end, blood inlet in the middle part of described whole blood pipeline connection bag, described blood cell pipeline initiating terminal is positioned at the blood cell mouth of another minor face end of bag; The separation process of blood continuous centrifugal completes in the soft bag of described separation; The soft bag inherence of described separation is separated the [θ of lacuna
1, θ
2) in interval, the blood plasma district namely between above-mentioned blood plasma mouth and blood inlet is provided with retention device.
The internal membrane that in the soft bag of described separation, retention device is corresponding with being separated soft bag is bonded together.
The initiating terminal of described retention device is positioned at blood plasma mouth, blood inlet and blood cell mouth and is separated on the same long limit of soft bag, distance between described retention device and blood plasma mouth is less than 1/2 of the spacing of blood plasma mouth and blood inlet, and it is highly for being separated 1/4 ~ 3/4 of soft bag bag width.
The height of described retention device and the distance between itself and blood plasma mouth are inversely proportional to.
Described retention device can by stretching to the tube wall of the plasma tube be separated in soft bag as its barrier structure, and this plasma tube length stretched in bag is greater than 2/3rds of the width of bag.
Described retention device is a thickness is 2 ~ 5mm semi-rigid plastic rod.
Described retention device directly bonds formation bonding width by being separated soft bag internal membrane is 2 ~ 5mm.
Described retention device is ramp shaped structure, and the bottom width of this ramp shaped structure is 5 ~ 15mm.When applying method of the present invention and carrying out the separation of blood plasma continuous centrifugal, blood enters into from the blood inlet being separated soft bag and is separated soft bag, whole blood containing various blood constituent fills gradually, and the inwall making the two side of the soft bag of separation be close to separation lacuna forms separated space.By the continuous action of centrifugal force, the visible component such as blood plasma and blood cell is separated gradually, from the low centrifugal force district of separated space near-end to the high centrifugal force field of far-end, is rendered as the distribution of the visible component segmentation and regionalizations such as blood plasma, whole blood and blood cell according to this.Assemble the non-separating whole blood of major part in the middle part of separated space and be called chaotic region, the low centrifugal force region of separated space near-end is called blood plasma district, the high centrifugal force region of separated space far-end is called blood cell district.
In the separated space of high speed rotating, due to the continuous action of centrifugal force, enter into from blood inlet the whole blood be separated in soft bag to flow and accumulation along the medial wall being separated soft bag to the separated space far-end that centrifugal force is higher, the near-end gradually to separated space after the far-end of this separated space is full of develops.
In the process that whole blood is piled up, be deposited in the whole blood of separated space distalmost end owing to being subject to the effect of centrifugal force comparatively greatly, the various compositions in whole blood start to be separated.Along with the continuous action of centrifugal force, blood plasma strengthens gradually with visible components such as blood cells and is separated, the blood inlet piled up to centre from separated space far-end after the visible components such as blood cell are separated develops, the blood inlet that blood plasma is then piled up to centre from separated space near-end develops, when these two kinds of deposits meet near blood inlet, there will be mixed interface, the whole blood simultaneously owing to constantly injecting impacts impact, the single component be separated herein mixes with whole blood, forms chaotic region.
When whole blood is full of soft bag and the visible components such as blood plasma and blood cell realize being separated, be separated the blood plasma that Plasma Pheresis/Apheresis Plasma standard appears meeting in soft bag near-end, blood plasma can be extracted out from the blood plasma mouth being separated soft bag near-end respectively and extract the visible components such as blood cell out with from the blood cell mouth being separated soft bag far-end, inject whole blood at blood inlet simultaneously, whole blood input quantity is the summation of blood cell and blood plasma extracted amount, thus it is constant to maintain the cumulative volume being separated liquid in soft bag, realizes dynamic equilibrium.
When blood plasma continuous centrifugal is separated collection, wish that the blood plasma mouth from being separated soft bag near-end continues to extract out the blood plasma meeting blood plasma collecting quality standard, but, in the actual application of curved body container in the past, in separation process, often occur that the visible components such as a small amount of blood cell are mixed in the blood plasma of extraction, thus affect the quality of Plasma Pheresis/Apheresis Plasma.
Under the dynamic balance state that in curved body container, continuous centrifugal is separated, form blood plasma separating interface between blood plasma district and chaotic region, its shape is comparatively special.Overlook direction from rotating shaft to observe, in visible separated space, blood plasma separating interface be that skew surface distributes along the lateral wall being separated lacuna proximal direction to the medial wall of disengagement chamber distal direction, and be blood cell outside separating interface, inner side is blood plasma; Observe from rotation shaft side apparent direction, visible blood plasma separating interface is from being from bottom to top that skew surface distributes to separated space top by being separated lacuna distal direction gradually by the near-end of blood plasma mouth along gravity direction bottom separated space, and top is blood plasma, and below is blood cell; And present a blood cell at separated space bottom margin and assemble line, it is the main reason causing blood cell to mix blood plasma that this blood cell assembles line.
Blood in separated space receives many-sided active force, and the flow dynamics analysis forming above-mentioned phenomenon is as follows:
One, blood itself is non-newtonian liquid, blood plasma in blood and visible component have significant viscosity, the negative pressure that the malleation of whole blood input and blood plasma blood cell extract has impelled the whole blood flow in separated space, and the lateral wall of separated space, medial wall produce frictional force to the flowing of whole blood, stop whole blood flow, the closer to sidewall, flow velocity is slower, produces current gradient lamination;
They are two years old, by the continuous action of centrifugal force, the visible component such as the blood cell that whole blood Midst density is larger trend is distributed in far-end and the lateral wall of separated space, thus is rendered as the distribution of the visible component segmentation and regionalizations such as blood plasma, whole blood and blood cell successively to the high centrifugal force field of far-end by the low centrifugal force district of near-end in separated space;
Its three, the impact of gravitate, the visible components such as the blood cell that separated space Midst density is larger trend towards the bottom being deposited in separated space.When blood plasma is extracted out by plasma tube fast in blood plasma district, blood plasma axial flow closes on the visible components such as the blood cell of separating interface and produces drag force to lateral wall and bottom, the bottom of these visible components against the component effect of centrifugal force along separated space is impelled to spread along blood plasma axial flow direction, form blood cell and assemble line, diffuse into even blood plasma mouth and affect the plasma purity of collection.
For this reason, the present invention arranges a retention device bottom the soft bag of separation, stops the visible components such as blood cell spread mobile along blood plasma axial flow to blood plasma mouth and be incorporated in blood plasma, improves the DNA purity of Plasma Pheresis/Apheresis Plasma.Before the visible components such as blood cell are advanced to retention device by drag force effect, due to the existence of retention device, the laminar flow that blood plasma axial flow brings is obstructed, because its prime kinetic energy effect can produce an elastic force contrary with its flow direction, form fluidised form herein disorderly and cause local turbulence, the visible components such as blood cell by this multinomial active force impact gradually before retention device, bottom sedimentation and backflow.Blood plasma axial flow produces the flowing break-in of ascent direction because of the existence of retention device herein simultaneously, also its drag force is made to produce the component effect of ascent direction, the visible components such as blood cell are driven to move up bottom separated space, if this retention device has certain altitude, the component of this part drag force is offset in the action of gravity this moved past in journey, the visible components such as blood cell effectively can be stoped to cross retention device and to arrive blood plasma mouth, thus improve the DNA purity of blood plasma.
Based on foregoing invention content, the soft bag of separation of the present invention is applied to and carries out having following technique effect in the method for continuous centrifugal separation compared with method of the prior art to blood:
1. the soft bag of separation of the present invention is in blood plasma continuous acquisition, prevents the visible components such as blood cell to be drawn out of by arranging retention device at the suitable position being separated soft bag, thus realizes the object improving blood plasma DNA purity.This retention device is very easily realize making in the soft bag of separation, and production cost increases atomic, but the effect of the raising purity realized is very huge.
2. the soft bag of separation of the present invention can make the component of counteract gravity forces drag force due to the existence of retention device, therefore likely in the system that same continuous centrifugal is separated, by arranging the retention device of proper height, and improving blood plasma extraction speed, realizing other technological innovation measure.
Accompanying drawing explanation
Fig. 1 is the structural representation of centrifugal separation system.
Fig. 2 is that the present invention carries out the polar coordinate schematic diagram of continuous curve surface in the method for continuous curve surface centrifugalize to blood.
Fig. 3 is the structural representation of separator disk in the present invention.
Fig. 4 is that in the present invention, retention device overlaps with plasma tube, by extending the soft bag structural representation of separation that plasma tube realizes in the length be separated in soft bag.
Fig. 5 schematic diagram that to be the retention device being separated soft bag in the present invention be in semi-rigid plastic rod situation.
Fig. 6 schematic diagram that to be the retention device being separated soft bag in the present invention be in the two side forms directly bonding situation that bag is relative.
Fig. 7 schematic diagram that to be the retention device being separated soft bag in the present invention be under ramp shaped structure situation.
Fig. 8 be blood just entered blood cell when being separated in lacuna flow to schematic diagram.
Fig. 9 be blood be full of be separated blood cell before lacuna flow to schematic diagram.
Figure 10 be blood just fully separated after gap of having one's bosom filled with blood cell flow to schematic diagram.
Figure 11 is the view that the Separation of the soft bag of separation not arranging retention device extracts point cloth-like of blood cell in Separation when blood plasma and blood cell reach balance respectively.
Figure 12 is the distribution schematic diagram extracting blood cell when blood plasma and blood cell reach balance in the present invention in separated space respectively.
Figure 13 is that separated space of the present invention comprises the plane stressing conditions schematic diagram of blood cell in interior visible component.
Figure 14 is the stressed schematic diagram of blood cell before retention device in separated space of the present invention.
Figure 15 is the fluidised form schematic diagram of blood cell before retention device in separated space of the present invention.
Figure 16 be in the embodiment of the present invention 1 blood just entered blood cell when being separated in soft bag flow to schematic diagram.
Figure 17 be in the embodiment of the present invention 1 blood be full of be separated blood cell after soft bag flow to schematic diagram.
Figure 18 is be separated in soft bag to start to extract blood plasma and erythrocytic view respectively in fact Example 2 of the present invention.
Figure 19 is that in the embodiment of the present invention 2, blood has just entered and erythrocyticly when being separated in soft bag flows to schematic diagram.
Figure 20 is that in the embodiment of the present invention 2, blood is full of to be separated and erythrocyticly after soft bag flows to schematic diagram.
Figure 21 is separated in soft bag in thing embodiment 2 of the present invention to start to extract blood plasma and erythrocytic view respectively.
Detailed description of the invention
We are separated soft bag with specific embodiment and do to of the present invention and further elaborate by reference to the accompanying drawings below, in the hope of understanding operation principle of the present invention and workflow more lucidly, but can not limit the scope of the invention with this.
The present invention relates to the soft bag of separation a kind of centrifugal blood system improving blood plasma DNA purity.The application of the soft bag of this separation is based on following principle: blood is placed in one and has the curved body separation container being separated lacuna, by this curved body container of high speed rotating, utilize the density size of composition in the different and blood of the centrifugal force of zones of different in curved body device, thus blood plasma in blood and other visible components are separated.
If realize isolating blood high-density composition and low-density composition continuously and efficiently.First to design one and be separated lacuna in curved body container, the shape of this lacuna includes the curved body of outer wall and inwall, separation container containing this curved body lacuna is called curved body container, can be reached the object of blood constituent high-efficiency and continuous centrifugalize by this curved body container and the Combination application being separated soft bag.The outer wall curved surface of above-mentioned separation lacuna is as follows with polar coordinate representation perpendicular to the curve that the plane of rotating shaft projects:
Wherein, as shown in Figure 1, polar limit O is the intersection point of rotating shaft and described plane, polar pole axis L is the ray that limit arrives curve initiating terminal direction, and the positive direction of polar angle is that r is the footpath, pole of any point on curve clockwise, R is the footpath, pole of curve distalmost end, θ
1for the polar angle of curve initiating terminal, its value is 0 degree of this polar coordinate system, θ
2for curve and blood plasma separating factor critical radius F
rthe polar angle of intersection point, blood plasma separating factor critical radius F
rfor blood plasma in unit interval when rotating speed is determined is separated required minimum centrifugal radius, θ
3be a polar angle, its value is θ
21.5 ~ 3.5 times, θ
4for the polar angle of curve distalmost end; In described separation lacuna, [θ
1, θ
2) be blood plasma district, [θ
2, θ
3) be chaotic region, [θ
3, θ
4] be blood cell district, b
1for the curve coefficients in blood plasma district, b
2for the curve coefficients of chaotic region, b
3for the curve coefficients in blood cell district.The form of expression due to drop shadow curve is helix, therefore defines key point wherein with footpath, pole, polar angle.Curve coefficients refers to the rate of change of footpath, pole relative to polar angle of any point on curve.Extract desired blood component out in the separation lacuna of curved body container while, constantly supplement whole blood again, make liquid capacity in separation lacuna reach a dynamic equilibrium, and then realize the object of blood continuous centrifugal separation.
The structure of curved body container includes the separation lacuna of curved body form, and this Vessel Design is a disc-shaped structure, can be referred to as separator disk, as shown in Figure 3.This separator disk comprises interior cylinder 1 and outer cylinder 2 two parts.Interior cylinder 1 is removably fixed in the inner chamber of outer cylinder 2, leaves certain space between the internal chamber wall of outer cylinder 2 and the lateral wall of interior cylinder, and this space is exactly the separation lacuna 3 on separator disk.Hold the soft bag of separation that once property uses in it, the separation process of blood continuous centrifugal is carried out in the soft bag of separation.Can the separator disk of Reusability and disposable separation soft bag time patent of the present invention inventive point place.
The above-mentioned soft bag of disposable separation is a kind of flat bag shaped structure with multiple liquid transmission pipeline, and Fig. 5 is the deployed configuration schematic diagram being separated soft bag in the present invention.The soft bag of described separation is by being separated soft bag bag and three pipelines being connected with bag form.Wherein, being separated soft bag bag is rectangular soft medical plastic bag; On the soft bag bag of this separation is long, be provided with three pipelines be communicated with inside and outside bag, lay respectively at be separated soft bag front portion, middle part, rear portion; Wherein, be positioned at apart from the nearest front portion of rotating shaft and originate in the pipeline of blood plasma mouth, its region is blood plasma district, is called plasma tube 4, for extracting isolated blood plasma; Be positioned at middle part and originate in the pipeline of blood inlet, its region is chaotic region, is called whole blood pipeline 5, for carrying whole blood in the soft bag of separation; Be positioned at apart from rotating shaft rear portion farthest and originate in blood cell mouth, its region is blood cell district, is called blood cell pipeline 6, for extracting isolated blood cell.
When applying method of the present invention and carrying out the separation of blood plasma continuous centrifugal, blood enters into from the blood inlet being separated soft bag and is separated soft bag, whole blood containing various blood constituent fills gradually, and the inwall making the two side of the soft bag of separation be close to separation lacuna forms separated space.By the continuous action of centrifugal force, the visible component such as blood plasma and blood cell is separated gradually, from the low centrifugal force district of separated space near-end to the high centrifugal force field of far-end, is rendered as the distribution of the visible component segmentation and regionalizations such as blood plasma, whole blood and blood cell according to this.Assemble the non-separating whole blood of major part in the middle part of separated space and be called chaotic region, the low centrifugal force region of separated space near-end is called blood plasma district, the high centrifugal force region of separated space far-end is called blood cell district.
As separator disk high speed rotating under the drive of flexible axle of centrifugalize container, the structure of its whole centrifugal separation system and operation logic illustrate in patent application 201020293871.4, as shown in Figure 2, repeat no more herein.Separator disk needs around the rotating shaft high speed rotating being positioned at center under the drive of flexible axle, for the centrifugalize of blood provides power.Flexible axle stretches into the rotary shaft position being connected and fixed on and being positioned at separator disk center, drive separation container rotates, described plasma tube 4, whole blood pipeline 5 are communicated with the tube for transfusion in flexible axle with blood cell pipeline 6, thus require that flexible axle possesses the dual-use function of power transmission and liquid transfer.
On centrifugalize container, there is an intersection point central shaft of separator disk and separator disk bottom surface, and this intersection point is the junction point of flexible axle and separator disk, are also the power resources points that separator disk rotates.When the whole blood containing whole blood composition enters in the soft bag of separation from blood inlet, because the outboard sidewalls of the soft bag bag of this separation and the lacuna 3 of separator disk fit formation separated space, namely can think that blood has entered in the separation lacuna 3 of centrifugalize container.In the separated space of high speed rotating, owing to being subject to the continuous action of centrifugal force, enter into from blood inlet the whole blood being separated soft bag to flow and accumulation along the medial wall being separated soft bag to the separated space far-end that centrifugal force is higher, near-end gradually to separated space after the far-end of this separated space is full of increases to be piled up, as shown in Figure 8.
In the process that whole blood is piled up, be deposited in the whole blood of separated space distalmost end owing to being subject to the effect of centrifugal force comparatively greatly, the various compositions in whole blood start to be separated.Along with the continuous action of centrifugal force, blood plasma strengthens gradually with visible components such as blood cells and is separated, the visible components such as blood cell are piled up from separated space far-end to the blood inlet of centre after being separated, blood plasma is then piled up from separated space near-end to the blood inlet of centre, when these two kinds of deposits meet near blood inlet, there will be mixed interface, the whole blood simultaneously owing to constantly injecting impacts impact, the single component be separated herein mixes with whole blood, forms chaotic region.Now the state of blood in the soft bag of separation as shown in Figure 9, in figure, the whole blood that is oriented to of arrow 8 enters separation lacuna 3 with the flow direction of backward disengagement chamber gap 3 far-end, figure arrow 9 is after whole blood is accumulated to blood inlet, and the whole blood fraction entered is to the direction being separated the flowing of lacuna 3 near-end.
When the input of whole blood be full of be separated soft bag and the visible components such as blood plasma and blood cell realize being separated time, there is the blood plasma meeting Plasma Pheresis/Apheresis Plasma standard in separated space near-end, can blood plasma be extracted out from separated space near-end respectively and extract the visible components such as blood cell out from separated space far-end, inject whole blood at blood inlet simultaneously, whole blood input quantity is the summation of blood cell and blood plasma extracted amount, thus the total liquid volume maintained in whole separated space is constant, realizes dynamic equilibrium.Blood and the various compositions separated thereof the state now in separated space as shown in Figure 10.In figure, arrow 8 and arrow 9 are respectively when whole blood enters separated space to the direction being separated lacuna near-end and far-end flowing, arrow 10 is positioned at the flow direction when blood plasma being separated lacuna 3 near-end is extracted out by blood plasma mouth, and arrow 11 is positioned at the flow direction when blood cell being separated lacuna far-end is extracted out by blood cell mouth.
When blood plasma continuous centrifugal is separated collection, wish that the blood plasma mouth from being separated soft bag near-end continues to extract out the blood plasma meeting blood plasma collecting quality standard, but, in the actual application of curved body container in the past, in separation process, often occur that the visible components such as a small amount of blood cell are mixed in the blood plasma of extraction, thus affect the quality of Plasma Pheresis/Apheresis Plasma.Trace it to its cause:
Under the dynamic balance state that in curved body container, continuous centrifugal is separated, form blood plasma separating interface between blood plasma district and chaotic region, its shape is comparatively special.Overlook direction from rotating shaft 15 to observe, in visible separated space, blood plasma separating interface is along medial wall 19 in the skew surface distribution of lateral wall 17 to disengagement chamber distal direction being separated lacuna proximal direction, and be blood cell outside separating interface, inner side is blood plasma; Observe from rotation shaft side apparent direction, visible blood plasma separating interface is from being from bottom to top that skew surface distributes to separated space top by being separated lacuna distal direction gradually by the near-end of plasma tube 4 along gravity direction bottom separated space, top is blood plasma, below is blood cell, and present a blood cell at separated space bottom margin and assemble line, as shown in figure 11.It is the main reason causing blood cell to mix blood plasma that this blood cell assembles line.
Blood in separated space receives many-sided active force, and as shown in figure 13, the flow dynamics analysis forming above-mentioned phenomenon is as follows:
One, blood itself is non-newtonian liquid, blood plasma in blood and visible component have significant viscosity, the negative pressure that the malleation of whole blood input and blood plasma blood cell extract has impelled the whole blood flow in separated space, and the flowing of the lateral wall 17 of separated space, the 19 pairs of whole bloods in medial wall produces frictional force 14, stop whole blood flow, the closer to sidewall, flow velocity is slower, produces current gradient lamination;
They are two years old, by the continuous action of centrifugal force, the visible component 16 such as the blood cell that whole blood Midst density is larger trend is distributed in far-end and the lateral wall 17 of separated space, thus is rendered as the distribution of the visible component segmentation and regionalizations such as blood plasma, whole blood and blood cell successively to the high centrifugal force field of far-end by the low centrifugal force district of near-end in separated space;
Its three, the impact of gravitate, the visible components such as the blood cell that separated space Midst density is larger trend towards the bottom being deposited in separated space, thus make these visible components closer to blood plasma mouth.When blood plasma is extracted out by plasma tube 4 fast in blood plasma district, blood plasma axial flow 20 pairs of lateral walls and bottom are closed on the visible components 16 such as the blood cell of separating interface and are produced drag force effect 12, impel the bottom of these visible components against the component effect of centrifugal force along separated space to spread along blood plasma axial flow direction 20, diffuse into even blood plasma mouth and affect the plasma purity of collection.
For this reason, the present invention arranges a retention device 7 bottom the soft bag of separation, stops the visible components 16 such as blood cell to spread movement along blood plasma axial flow 20 to blood plasma mouth, thus stops that the visible components such as blood cell are drawn out of, and improves the DNA purity of Plasma Pheresis/Apheresis Plasma.The Curve guide impeller of the soft bag structure of above-mentioned separation is as shown in Fig. 4, Fig. 5, Fig. 6, Fig. 7, and the blood plasma district between described blood plasma mouth and blood inlet is provided with retention device 7.Above-mentioned retention device 7 is one and half partition-type structures when blood carries out centrifugalize, and this structure is because the drag force effect 12 by blood plasma axial flow 20 makes blood cell mix the physical unit of blood plasma when can stop that blood plasma extracts.Blood and the various compositions separated thereof are now being separated the state of soft bag as shown in figure 12.
As shown in Figure 14, Figure 15, before the visible components such as blood cell 16 are advanced to retention device 7 by drag force 12 effect, due to the existence of retention device 7, the laminar flow that blood plasma axial flow 20 brings is obstructed, because its prime kinetic energy active force can produce an elastic force 21 contrary with its flow direction, fluidised form can be formed herein disorderly and cause local turbulence, the visible components such as blood cell 16 by this multinomial active force impact gradually before retention device 7, bottom sedimentation and backflow.Simultaneously blood plasma axial flow produces the flowing break-in of ascent direction because of the existence of retention device herein, also the component effect making its drag force 12 produce ascent direction drives the visible components such as blood cell to move up bottom separated space, if this retention device 7 has certain altitude, the gravity 22 this moved past in journey acts on the component of offsetting this part drag force 12, the visible components such as blood cell effectively can be stoped to cross retention device 7 and to arrive blood plasma mouth, thus improve the DNA purity of blood plasma.
Retention device 7 in the soft bag of above-mentioned separation is thickness 2 ~ 5mm semi-rigid plastic rod, and the both sides inwall of retention device and bag is bonded together.Retention device 7 also can be directly be bonded by the both sides inwall film being separated soft bag, and its width is 2 ~ 5mm.Retention device 7 can also make a ramp shaped structure, and its bottom width is 5 ~ 15mm.
As the general requirement of retention device, retention device 7 be separated input and output channel in soft bag be positioned at be separated soft bag same long limit on, distance between itself and plasma tube 4 is less than 1/2 of the spacing of plasma tube 4 and whole blood pipeline 5, and it is highly for being separated 1/4 ~ 3/4 of soft bag bag width.When retention device excessive height, the space being positioned at the blood plasma flowing above retention device diminishes, and will affect blood plasma to the flowing of blood plasma mouth, thus affect the separation efficiency of blood plasma.And when highly too low, the visible component such as blood cell that blood plasma axial flow and the drag force zone of action produced are come, suffered drag force effect is greater than its action of gravity be subject to and crosses retention device and enter blood plasma mouth, affects the purity of blood plasma.
As in an optimal design of retention device, can by the position of blood plasma mouth in the soft bag of separation be promoted the object reaching the DNA purity improving blood plasma.Based on above-mentioned thinking, take plasma tube to stretch to be separated in soft bag making the opening of plasma tube as blood plasma mouth.The length stretched into is greater than 2/3rds of the width being separated soft bag bag, be separated the tube wall of plasma tube in soft bag as retention device, now the drag force component upwards that produces of the axial flow of blood plasma is minimum, along with the lifting of climb altitude, farthest can reduce the probability entering blood plasma mouth at the blood cell of separating interface critical zone under gravity, and the extraction efficiency of blood plasma is not affected.In this state, retention device need not being set specially, its function can being realized only by extending the length of plasma tube in the soft bag of separation.Meanwhile, it is more succinct that above-mentioned design also makes to be separated soft bag structure, manufactures more convenient.
Embodiment 1
As shown in Fig. 6, Figure 16, Figure 17 and Figure 18, being separated soft bag in the present embodiment is a kind of flat bag shaped structure with multiple liquid transmission pipeline, and it structurally includes three pipelines being separated soft bag bag and being connected with bag.Wherein, being separated soft bag bag is rectangular soft medical plastic bag, and the long limit of the soft bag of this separation is provided with three pipelines be communicated with inside and outside bag, be respectively be positioned at be separated the front portion of soft bag, middle part and rear portion.Be arranged in front portion and the region extending into the pipeline place being separated soft bag is the blood plasma district being separated lacuna, because the density of blood plasma is less, be in the nearest position of distance rotating shaft being separated in lacuna, therefore claim this pipeline to be plasma tube 4.Being arranged in middle part and the region stretching into the pipeline place being separated soft bag is the chaotic region of separation lacuna, for carrying whole blood in the soft bag of centrifugalize, being referred to as whole blood pipeline 5.Be positioned at the pipeline connection at rear portion and extend into the soft bag of separation, because the density of blood cell is larger, distance rotating shaft position is farthest in separation lacuna, the region at this pipeline place is the blood cell district be separated in lacuna, therefore claim this pipeline to be blood cell pipeline 6, for extracting isolated blood cell for extracting isolated blood plasma from the soft bag of separation from the soft bag of separation.
The present embodiment is that the blood plasma district in the soft bag of separation is provided with a ramp shaped structure barrier device 7, and the bottom width of ramp shaped structure is 5 ~ 15mm.Its central point is 1/2nd of its central point distance whole blood pipeline distance apart from the distance of plasma tube, and it is highly for being separated the half of soft bag bag bond length.
When the whole blood containing whole blood composition to enter from blood inlet be separated in soft bag time, because the soft outboard sidewalls of bag bag of this separation and the lacuna of separator disk fit formation separated space, namely can think that blood has entered in the separation lacuna 3 of centrifugalize container.In the separated space of high speed rotating, owing to being subject to the continuous action of centrifugal force, enter into from blood inlet the whole blood being separated soft bag to flow and accumulation along the medial wall being separated soft bag bag to the separated space far-end that centrifugal force is higher, near-end gradually to separated space after the far-end of this separated space is full of increases to be piled up, as shown in Figure 16, Figure 17.
When the input of whole blood is full of soft bag, blood plasma is separated with the realization of the visible components such as blood cell, there is the blood plasma meeting Plasma Pheresis/Apheresis Plasma standard in separated space near-end, blood plasma can be extracted out respectively from separated space near-end, extract the visible components such as blood cell out from separated space far-end, inject whole blood at blood inlet, whole blood input quantity is the summation of blood cell and blood plasma extracted amount simultaneously, thus ensure that the cumulative volume of whole blood, blood plasma and the blood cell in whole separated space remains unchanged, realize dynamic equilibrium.Blood and the various compositions separated thereof the state now in separated space as shown in figure 18.
Whole blood input and blood plasma and blood cell output procedure dynamic equilibrium in, the blood in separated space receives many-sided active force.One, blood itself is non-newtonian liquid, the visible components such as the blood cell in blood have significant viscosity, the malleation of input and the negative pressure of output have impelled the whole blood flow in separated space, and the flowing of the lateral wall 17 of separated space, the 19 pairs of blood cells 16 in medial wall produces frictional force 14, stop whole blood flow, the closer to sidewall 19, flow velocity is slower, produce current gradient lamination, flowing (its direction is as shown in arrow in Figure 14 20) drag force 12 to visible components such as blood cells of blood plasma, makes the direction flowing that the visible components such as blood cell flow along with blood plasma; They are two years old, by the continuous action of centrifugal force, the visible component such as the blood cell that whole blood Midst density is larger trend is distributed in far-end and the lateral wall 17 of separated space, thus is rendered as the segmentation distribution of the visible components such as blood plasma, whole blood and blood cell successively to the high centrifugal force field of far-end by the low centrifugal force district of near-end in separated space; Its three, the impact of gravitate, the visible components such as the blood cell that the density in separated space is larger trend towards the bottom being deposited in separated space.
For this reason, when blood plasma is extracted out by plasma tube fast in blood plasma district, the gravity effect that the visible components such as the blood cell on blood plasma generation axial flow oppose side wall produce drag force 12 and self are subject to, the bottom of these visible components against the component effect of centrifugal force along separated space is impelled to spread along blood plasma axial flow 20 direction, as shown in figure 11, the blood cell spread moves to blood plasma mouth, even can affect the plasma purity of separation.When blood cell along be separated bottom soft bag along blood plasma axial flow 20 spread direction run into ramp shaped retention device 7 time, the visible components such as the blood cell that can cut off extension move to blood plasma mouth position, simultaneously formed backflow by visible components such as the part blood cells that stops because of the existence of ramp shaped retention device 7 to flow to blood cell district under the effect of centrifugal force 13, thus improve the purity that blood plasma district extracts blood plasma, as shown in figure 18.
Embodiment 2
As shown in Fig. 4, Figure 19, Figure 20 and Figure 21, be separated difference in the structure of soft bag and embodiment 1 in the present embodiment to be, as a kind of optimal design, plasma tube stretches to and to be separated in soft bag and the length stretched into is greater than 2/3rds of the width being separated soft bag bag, is separated the tube wall of plasma tube in soft bag as retention device.Retention device and the part of plasma tube in the soft bag of separation, its length is greater than 2/3rds of the soft bag bag bond length of separation.
Because the retention device 7 in the present embodiment is equivalent to the position that improve plasma tube outlet, the blood plasma being so only positioned at plasma outlet port position is just extracted out by plasma tube 4, even if part blood cell invades the bottom section of plasma tube, the position that plasma tube 4 exports can not be arrived under the effect of gravity and centrifugal force, namely the pure blood plasma being positioned at blood plasma district upper position just can be drawn out of, the meeting being positioned at blood plasma district inner bottom part is subject to the region that blood cell invades and then can not be drawn out of, this ensures that there the degree of purity that blood plasma extracts, improve the efficiency that blood plasma extracts.
Certainly, the soft bag of separation improving blood plasma DNA purity of the present invention, except the version enumerated in above-described embodiment, can also design the type structure form that other are similar.Generally speaking, protection scope of the present invention also comprises other conversion that it will be apparent to those skilled in the art that and substitutes.
Claims (7)
1. when a blood is continuously separated, improve the soft bag of separation of blood plasma DNA purity, the pipeline that the soft bag of this separation comprises bag and is attached thereto, a long limit of this bag is provided with blood plasma mouth, blood inlet and blood cell mouth, it is characterized in that, position near blood plasma mouth between blood plasma mouth and blood inlet in the soft bag of described separation is provided with a retention device, the initiating terminal of described retention device and blood plasma mouth, blood inlet and blood cell mouth are positioned on the same long limit of the soft bag of separation, distance between described retention device and blood plasma mouth is less than 1/2 of the spacing of blood plasma mouth and blood inlet, it is highly for being separated 1/4 ~ 3/4 of soft bag bag width.
2. improve the soft bag of separation of blood plasma DNA purity when a kind of blood according to claim 1 is continuously separated, it is characterized in that, the internal membrane that in the soft bag of described separation, retention device is corresponding with being separated soft bag is bonded together.
3. improve the soft bag of separation of blood plasma DNA purity when a kind of blood according to claim 1 is continuously separated, it is characterized in that, the height of described retention device and the distance between itself and blood plasma mouth are inversely proportional to.
4. when a kind of blood according to claim 3 is continuously separated, improve the soft bag of separation of blood plasma DNA purity, it is characterized in that, described retention device can by stretching to the tube wall of the plasma tube be separated in soft bag as its barrier structure, and this plasma tube length stretched in bag is greater than 2/3rds of the width of bag.
5. improve the soft bag of separation of blood plasma DNA purity when a kind of blood according to claim 1 is continuously separated, it is characterized in that, described retention device is a thickness is 2 ~ 5mm semi-rigid plastic rod.
6. improve the soft bag of separation of blood plasma DNA purity when a kind of blood according to claim 1 is continuously separated, it is characterized in that, described retention device directly bonds formation bonding width by being separated soft bag internal membrane is 2 ~ 5mm.
7. improve the soft bag of separation of blood plasma DNA purity when a kind of blood according to claim 1 is continuously separated, it is characterized in that, described retention device is ramp shaped structure, and the bottom width of this ramp shaped structure is 5 ~ 15mm.
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| US4863452A (en) * | 1986-02-12 | 1989-09-05 | Minntech Corporation | Venous reservoir |
| US5656163A (en) * | 1987-01-30 | 1997-08-12 | Baxter International Inc. | Chamber for use in a rotating field to separate blood components |
| US5102407A (en) * | 1990-03-13 | 1992-04-07 | Miles Inc. | Blood separation system |
| US5154716A (en) * | 1990-11-06 | 1992-10-13 | Miles Inc. | Bottom blood bag separation system |
| JPH06105904A (en) * | 1992-09-28 | 1994-04-19 | Nissho Corp | Blood separation and blood bag set |
| JP3283641B2 (en) * | 1993-06-29 | 2002-05-20 | テルモ株式会社 | Blood processing method |
| JP3163608B2 (en) * | 1993-04-23 | 2001-05-08 | 株式会社ニッショー | Blood separation method |
| US5525218A (en) * | 1993-10-29 | 1996-06-11 | Baxter International Inc. | Centrifuge with separable bowl and spool elements providing access to the separation chamber |
| WO2000062828A1 (en) * | 1996-04-30 | 2000-10-26 | Medtronic, Inc. | Autologous fibrin sealant and method for making the same |
| CN101172207B (en) * | 2007-10-12 | 2012-09-05 | 经建中 | Separator disk on multi-cell component mix liquid separating system and application method of the same |
| CN201676759U (en) * | 2010-08-17 | 2010-12-22 | 金卫医疗科技(上海)有限公司 | Differential centrifugal separation system for mixing liquid |
| CN202526573U (en) * | 2012-01-09 | 2012-11-14 | 金卫医疗科技(上海)有限公司 | Soft separation bag for separating high-purity blood plasma |
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