JPS5850963A - Serum separating apparatus - Google Patents

Abstract

(57) [Summary] This bulletin contains application data before electronic filing, so abstract data is not recorded.

Description

DETAILED DESCRIPTION OF THE INVENTION 1. Background of the Invention Technical Field The present invention relates to a plasma separation device that separates plasma by passing blood through a filtration membrane.

Prior Art Conventionally, the pore diameter is 0.1-1. There are two types of filtration-type slender separators for continuous P1 separation of blood using a microporous membrane having a diameter of about θ microns: a hollow fiber type and a flat membrane type. The hollow fiber type is widely used because it allows for a large filtration face plate, requires fewer members, and is easy to operate. However, in the hollow fiber type, the pore shape becomes slightly oval due to the fact that tension is applied in the longitudinal direction of the tube compared to a flat membrane during membrane formation, and because there is no support during membrane formation. Also,
Since it is difficult to maintain uniform tension during film formation, it is difficult to make the pore diameters uniform. For this reason, not only does the pore distribution of the obtained hollow fiber membrane become wide-ranging, but also the variation in loft of one membrane is considerably larger than that of a flat membrane. Due to this fact, during filtration, the maximum pore diameter must be selected rather small in order to prevent blood cells from leaking into the plasma, resulting in a low permeability for high-molecular plasma components. Further, when the length of the upstream path of the structure is shortened, both ends of the hollow fiber membrane are covered with a potting agent, which increases the loss of effective surface right, and also reduces the possibility of leakage and productivity.

For this reason, the length of the tube (flow path length) must be increased, resulting in a large pressure loss, and because the tube diameter cannot be reduced due to membrane manufacturing technology, the filtration efficiency per membrane unit surface area decreases. For this reason, the membrane thickness can be reduced, the filtration rate per unit area of the membrane can be increased, and the
One good method is to aim at improving the transmittance of V-quality, but this reduces the strength and increases the risk of leakage, while also increasing the variation in pore size of the membrane.

On the other hand, the flat membrane glaze layer type has a wider selection of membranes and is stable in performance, so although it is expected to be small and high performance, the analysis of the filtration engineering mechanism has not been sufficient. It is said that it is difficult to realize it because it has not been done, and it is difficult to solve hematological problems that cannot be solved by calculation alone, as well as the membrane shape and module structure to uniformly form an extremely fine thin layer. However, as a flat membrane laminated type plasma separator, there is, for example, one shown in FIG. 1 in the past. This device has a rectangular frame-shaped backing part 6b with an empty space wR6a between a side plate 3 having a blood inlet port 1 and a blood outlet part 2 and a side plate S having a plasma outlet part 4. The channel forming plate 6, the filtration membrane 7, and the plasma flow channel forming plate 8 provided with a backing part 8b around the mesh plasma flow part 18a are superposed to hold them liquid-tightly and fixed. . In this device, blood flowing in from the blood inflow port 1 passes through the gap 6a and is filtered by the filtration membrane 7, and blood cell components flow from the blood outflow port 2 and from the plasma flow port 4 through the plasma distribution port 8a. Each is discharged.

However, this device had the following problems in terms of filtration characteristics. In other words, in this type of plasma separation device, it is known that the thinner the blood flow path, the greater the wall shear velocity of the filtration membrane, resulting in better filtration characteristics. In the flow path forming plate 6
By reducing the film thickness, it is possible to reduce the channel thickness of the void 6a through which blood flows. However, since the filtration membrane 7 is easily deformed, the blood flow path formed by the void 6a cannot maintain a uniform flow path thickness set by the thickness of the flow path forming plate 6, resulting in large variations. For example, even if the channel thickness is set to 300 microns, an error of about ±100 microns will occur. Therefore, even if the flow path forming plate 6 is formed extremely thin in this device, it is difficult to secure a desired filtration amount, and the variation is significant.

In order to overcome the drawbacks of such a separation device, filtration is carried out through a rubber gasket having three parallel channels on each side of an elongated manifold plate forming a blood inlet at one end and a blood outlet at the other end. The membranes are brought into contact with each other, and these filtration membranes are pressed against a collecting plate equipped with a plasma p liquid port.
Over-loaded koji has been proposed (Trans, Am, So
c, Ar11if, Intern, Organs
+ XXIL21-26 (1978) Ding. However, such a device has a problem in practical use because the flow path is long compared to the width of the flow path, resulting in a large pressure loss.

At least one stomach-like filter is provided, which is bordered on at least one side by the filtration medium, below which a filtrate discharge member is arranged, and which has an inlet for the medium to be filtered and an outlet for the medium concentrated by the filtration. Ultrade application device particularly suitable for hemofiltration, consisting of a chamber with an inner diameter of not more than 2.5 cm and a base layer of fabric of fiber mesh with a thickness of 0.1 to 0.5 cm. An ultrafiltration device arranged between chamber walls is known (UK Patent No. 1,555,389). However, since such devices are used for ultrafiltration, they are subject to large negative pressures, and there is a structural limit to reducing the channel thickness, so the wall shear rate of the filtration membrane is low, and proteins and blood cells There was a drawback that it was easy to cause clogging due to adhesion of the like to the membrane surface. This clogging causes blood to stagnate, causing problems of blood damage such as hemolysis and coagulation.

M. OBJECTS OF THE INVENTION It is therefore an object of the present invention to provide a novel plasma separation device. Another object of the present invention is to provide a plasma separation device that minimizes damage to blood and decreases in separation performance over time, ensures sufficient filtration rate, and has a satisfactory economical membrane shape and number of laminated layers. I'm inclined to do that.

However, these sub-objectives are (a) with a diameter of 2 to 2 in the center.
It has a circular opening of 8 cm and is concentric with an outer diameter of 10 to 20 m, the ratio of the opening diameter to the outer diameter is 1 = 2 to 1:5, and the hole diameter is 0.1 to 0. .A circular filtration membrane having micropores of 8 microns, (b) a blood flow path formed on one side of the filtration membrane with a gap of 50 to 150 microns, and (C) provided on the layer surface of the filtration membrane. a circular plasma flow path forming member that forms a plasma flow path and has a central opening;
(d) 2 to 60 of the filtration membranes are integrally stacked together via a sealing material to avoid mixing of blood and plasma, resulting in a total filtration membrane area of 100 to 8000; The laminate thus formed is housed in a main body having a blood inlet, a filtration residue outlet, and a plasma outlet.
) Blood injected from the blood inlet passes through the blood flow path, plasma is separated by the filtration membrane, and then reaches the filtration residual liquid outflow port, and plasma filtered and separated by the filtration membrane passes through the plasma flow path. This is achieved by a plasma separator & which is characterized in that a liquid path is formed through a plasma flow path formed by a forming member to a plasma outflow port.

Detailed description of the Seal 0 invention Hereinafter, the present invention will be explained with reference to the drawings.

That is, as shown in FIGS. 2 and 3, there is a cylindrical case 13 equipped with a blood inlet 11 and a side wall KF"61 residual liquid outlet 12 in the center of the bottom, a plasma outlet 14, and a liquid-tight periphery. It consists of a main body 17 consisting of a lid body 16 to which an O-ring 15 is attached as a means, and a filtration membrane, a blood flow path regulating plate, and a plasma flow path forming member are housed within the main body 17.

That is, a circular plasma flow path diagonal member 20 made of a screen mesh having an opening 18 in the center and plasma passage holes 19 near the periphery is placed above and below two circular filtration membranes 21a, 2.
1b, and seal the periphery thereof and the periphery of the central opening by heat fusion, adhesive, etc., and attach a sealing material 26 to the outer periphery of the plasma passage hole 19 to complete the filtration membrane unit 22. Let it form. Here, circular plasma Ni: tract forming member 2
The mesh o can be used to define the plasma flow path, but the mesh is not limited to the above-mentioned mesh as long as the mesh is θ.

m1 sheet of sieving membrane unit 22 is opened, the unit 22
Central opening 18 corresponding to and plasma passage f(,] 9
A circular liquid flow path regulating plate 23 is provided, which is provided with a large number of convex portions on both sides (the outer periphery of the passage hole 19 is flat, however). Further, above the top and below the bottom of the filtration membrane unit 22, the circular blood flow path regulating plate 23 or a center plate corresponding to the unit 22 is provided.
The circular blood flow path regulating plate 24 is provided with a mouth portion 18 and a plasma passage hole 19, and has a large number of convex portions on one side (however, the outer periphery of the passage hole 19 is flat). Place them so that their sides are touching. 1 to 30 of these filtration membrane units 22 and blood flow path regulating plates 23, 24 (2 to 60 filtration membranes) are stacked and inserted into the case 13, and the lid 16 is placed on it and pressed. and fit it into the case 13. ring 1 by tightly sealing the 3rd
As shown in the figure, blood oozes 0 or 1. Due to such pressure, the filtration membrane unit 22 and the blood flow path regulating plates 23 and 24 are integrally connected at the outer periphery of the plasma passage hole 19 by the sealing material 26. The passage holes 19 are formed in communication.

In addition, although the example in which the plasma outflow hole 14 is provided in the lid body 16 has been described above, the plasma outflow hole 14 is not necessarily provided in the lid body 16.
Is it not necessary to provide any outflow hole in the lid body 16? <(, plasma outflow hole 14.1 at the bottom of the case 13
Of course, '4' may also be provided.

Therefore, the above P*$21a and 21b are made of cellulose esters such as organic acid esters such as Ml cellulose and cellulose acetate, and synthetic resin thin films such as polycarbonate (thickness: 50 to 200 microns, preferably 130 to 170 microns). A membrane formed by a phase separation method, an extraction method, a stretching method, a charged particle irradiation method, etc. 1 The pore size is 0.1 to 0.8 microns, preferably 0.2 to 0.6 microns, and the porosity is 4.
0 to 90%, preferably 60 to 90%, and is circular in shape with a circular opening 18 in the center. Its central opening diameter ID is 2~8aR1 outer diameter OD is 10~2ocr
II, the ratio ID:0D=1:2 to 1:5, and the total number of elm layers is 2 to 60 (1 to 30 for the filtration membrane unit 22).

The pore size of the filter membranes 21ae21b can be determined by (a) mercury intrusion method, (b) electron microscopy method, (C) permeation method using fine particles of known particle size (standard particles, microorganisms, etc.), and (d) bubble point method (ASTM). -F316-70), etc., but the apparent pore diameter and effective pore diameter may differ depending on the surface condition, and in the Soubun Benyo 6 film forming method, if the maximum pore diameter is indicated, the minimum pore diameter and fine pore diameter are measured. Since the pore distribution etc. can be easily estimated and furthermore, it is easy to measure, the pore diameter is indicated by the maximum pore diameter using bubble points. Usually 1.
In the case of a hydrophilic membrane, a hydrophilic agent is applied to the surface of the membrane or added to the resin that makes up the membrane, so the liquid used to measure the bubble point is extracted from or added to the membrane. Mineral oil with known surface tension that does not dissolve bleached materials (
The measurement can be carried out using water (light oil, white kerosene, etc.), or by thoroughly washing and extracting the hydrophilizing agent with distilled water. Is it possible to use plasma separation with a maximum pore size of 0.005 to 1.2 microns? When b i5 is near the lower limit, the permeation of the polymer substance becomes insufficient, while when it is near the upper limit, blood cell components leak, so the above range is practically preferable.

The porosity is determined by the weight of the membrane unit area being W (7) and the membrane thickness being 1 (f
fi), and the specific gravity of N is S(f/i), the apparent specific gravity is w/t(f/d), so it is as follows.

Open area rate = -22 ahead! Mu'! -X 1 (!O<%) However, although it is technically possible to achieve a porosity of 40 to 90% in 6-product i' due to phase separation, if it exceeds 90%, the mechanical strength of the shell is insufficient. On the other hand, 40% reduction is unsuitable for normal filtration due to membrane resistance, clogging, etc. A higher δf is advantageous in practical terms for plasma separation, but from a cost perspective, 60 to 90% is preferable (variation in filtration rate ±12.5%).
%).

Technically, it is possible to form a film with a thickness of 50 to 200 microns; if it is less than 50 microns, the mechanical strength is insufficient, and if it exceeds 200 microns, the pore distribution will become wider and the maximum pore diameter will become smaller. Since it is forced to endure bending, the material permeation efficiency decreases and product performance variations also increase.

In addition, the ID:OD ratio of the filtration membrane is set to 1 = 2 to 1:5, and the total @ area is set to 1000 to 5ooo,,y because the ratio exceeds this value or the membrane area exceeds this value. If it is less than that, blood damage will be large and blood W1 clots will likely occur.

On the other hand, if the ID n OD ratio is less than the above value, the economic loss due to providing the opening in the center of the membrane will be large, and if the membrane area exceeds the above value, the shear rate will decrease.
This method is economically undesirable because the separation performance is lowered and a large amount of membranes are used.

The plasma flow path forming member 20 is formed of a circular open screen mesh made of synthetic resin such as polyester, polypropylene, polyamide, etc. and having a central opening.

The blood flow path regulating plates 23 and 24 include the filtration membranes 21a and 21
It forms a blood flow path between the tube and the tube, and as shown in FIGS. 4 and 5, it has a circular shape with a central opening and a large number of convex portions 25. This blood flow path regulating plate 23 may be hard or flexible and elastic. Those that are flexible and elastic have a Young's modulus of 1.0XI06 to 2. OX 10'0dyne/
(111% preferably 1.OX 10' to 1.OX 1
0 dyne/c! It is made of Il material. The reason for this is that when the separation device is pressed to easily narrow and relax the blood flow path, the flow path reversibly restores itself, making it easier to obtain the desired filtration amount. Examples of materials having a Young's modulus in this range include low-density polyethylene, silicone rubber, in-prene rubber, butyl rubber, styrene-butadiene rubber (SBR), and ethylene-vinyl acetate copolymer resin (EVA). Further, the convex portion 2
It is preferable that the surface hardness of the body fluid flow path regulating plate having a Shore A hardness of 10 to 100 is 10 to 100. The convex portions 25 of the blood circulation regulating plates 23 and 24 are connected to the outer membrane 21a, .
2 lb to prevent deformation and ensure a blood flow path in the gap between the protrusions 25. Convex portion 25
It is preferable that the thickness of the channel formed between the two membrane surfaces is 50 to 150 microns. The reason for this is that if the thickness is less than 50 microns, it is difficult to adjust the channel thickness, and if it exceeds 150 microns, the deformation is large and errors are likely to occur, and the wall shear rate cannot be increased. Further, the spacing between these convex portions 2'5 is preferably 100 to 2000 microns, particularly preferably 400 to SOO microns. In addition, the radius of the bottom of the convex part, the length of the diagonal or one side, and the convex part.
The distance ratio between them is preferably 1:1 to 1:3.

As mentioned above, the main body includes the tube case 13 and the lid body 16.
It is made of hard plastic materials such as polycarbonate, polyamide, polyacetal, ^B8 resin, and hard polyvinyl chloride.
3 in a fluid-tight manner.

As the liquid-tight means, other than the method of fitting an O-ring around the peripheral edge of the lid body 1.6, other known sealing means can also be used. FIG. 6 shows another embodiment of the present invention. , 2nd~
In a plasma separation device similar to the embodiment shown in FIG.
6 is fitted into the main body 117 through a 01J ring 115 fitted around the peripheral edge thereof as a liquid-tight means, forming a circular plasma flow path having an opening 118 in the center and a plasma passage hole 119 near the periphery. A unit made by stacking and storing a plurality of units (2 to 60 filter membranes) in which both sides of the member 120 are in contact with the filtration membrane 121 with a sealing material 126 interposed in the vicinity of the opening 119. It is. In this case, the plasma flow path forming member 120 is similar to the blood flow path regulating plate in the apparatus shown in FIGS. Since the unevenness causes unevenness on the membrane surface, a blood flow path is formed between the membrane surfaces, and the gap therebetween is 50 to 150 microns, preferably 70 to 100 microns. In this case, a flat plate with a smooth surface may be provided between each filtration membrane unit as a plasma flow path forming member. FIG. 7 shows still another embodiment of the present invention. In a plasma separation device similar to the embodiment shown in Figure 3,
A cylindrical case 213 equipped with a filtration residual liquid outlet 212, a blood inlet 211, and a plasma outlet 214, and a main body 217 fitted through an O-ring 215 externally fitted on the periphery as a liquid-tight means. A circular plasma flow path forming member 220 made of a relatively coarse open screen mesh with an opening 218 at the periphery and a plasma passage hole 219 near the periphery.
Two upper and lower circular filtration membranes 221a + 221b are sandwiched between the membranes, and the periphery of the membrane and the periphery of the center opening are sealed by heat fusion, adhesion, etc., and a sealing material 2-26 is placed around the outer periphery of the plasma passage hole 219. is adhered to form the filtration membrane unit 222. 1 to 30 pieces of this filtration membrane unit 222 (
By storing 2 to 60 filtration membranes in the main body 217, a plasma separation device can be obtained. In this case, a blood flow path regulating plate is not used, but a coarse open screen mesh is used as a plasma flow path forming plate.
Gate protrusions corresponding to the irregularities of the mesh are formed on the membrane surface, and a blood flow path with a gap of 50 to 150 microns is formed on the opposing membrane surface.

Next, the operation of the plasma separator according to the present invention will be described. That is, as shown in FIG. It is introduced into the inlet 11 . The blood introduced into the device 17 passes through the opening 18 through the blood flow path regulating plates 23, 24 and the filter membrane 21, as shown in FIG.
While flowing through the blood flow path formed between a+21b, the plasma is filtered by a filtration membrane, and the plasma flows between the plasma flow path forming members 20, passes through the plasma passage hole 19, flows out from the plasma outlet 14, and is then weighed. It is collected in a container 34. On the other hand, the blood cells are discharged together with the filtered residual liquid from the K filtered residual liquid outlet 12, and are returned to the human body or the blood container through the circuit outlet 36 through the chamber 35. In addition, in the figure, 37 and 38 are pressure gauges.

Examples 1 to 12 and Comparative Examples 1 to 17 Using the apparatus shown in FIGS. 2 and 3, blood was passed under the experimental conditions shown in Table 1, and the r excess was measured. The results are shown in Table 1. Note that cellulose acetate having an average pore diameter of 0.3 to 0.5 microns was used as the membrane material.

Q -u'+ to t-oo■effect=enemy==5=first
In Table 9, the width of the blood flow path in the filtration device is a, the thickness of the blood flow path is b, the length of the blood flow path is t, the blood flow rate is QB, the blood viscosity is μ, the gravity unit conversion coefficient is ga, and the filtration device is If the pressure drop is PD, the shear rate is J, and the filtration flow rate is QF, then QF = α・! j)'・S (1) (However, α and β are membrane coefficients, and S is the membrane surface hta−L. Note that the channel width a indicates the average channel width, and the circular In the case of a membrane, it is determined by the following formula.

a = jaw π7; mark It is a value and is obtained by transforming equation (1). The blood flow path length t is the length along the blood flow direction, and in this case, it is the value obtained by subtracting the diameter of the circular opening from the outer diameter of the membrane, divided by 2, and is the length measured along the radial direction of the membrane. The length from the inner circumference to the outer circumference. The blood flow rate Qn represents the amount of blood flowing through the blood flow path per unit time.

In the case of the same membrane area and the same blood flow rate, the blood flow path shape should theoretically be as large as possible, with the flow path width a being as large as possible, and the flow path length t and the flow path thickness being small in balance with the flow path width a. Moderate. In other words, it is desirable to reduce the pressure loss that causes hemolysis and to increase the shear rate in order to increase the filtration rate QF.

Therefore, the channel thickness should be as small as possible, and theoretically 0〈b
Ideally, it should be ≦150 microns, but in practice, taking into account dimensional errors, deformation, and distortion of the membrane and support,
On the other hand, the wider the flow path Sb, the more uneven blood flow (channeling) occurs, so the practical limit is preferably 50 microns or more.

The filtration efficiency E (total) indicates how much of the plasma contained in the supplied blood has been filtered and separated, and is expressed by the following equation. In the formula, Pt is the amount of plasma contained in a unit blood volume.

QF E = -X 100 The pressure loss that causes hemolysis is as shown in the critical pressure loss curve at a hemoglobin concentration of 501 mg/dt shown by track 11A in Table 1 and FIG. 9 in relation to the shear rate.

The permissible limit for blood free hemoglobin concentration due to hemolysis is 100111/di or less from a medical perspective, but as a practical safety range it is desirable to keep it below 50 capes/di, O≦PD≦0.2Kg/a/ I TMP≦o, 1Kg/all (TMP: diaphragm pressure) In order not to exceed the critical TMP value that causes hemolysis, the free hemoglobin 7 concentration in the blood is 50'1st/all.
It is possible to keep it to approximately dt. Further, below the track IIA in Fig. 9, the blood free hemoglobin concentration is 50 /d7! It is possible to suppress
It is preferable that the pressure loss is within this range.

In addition, the pressure loss is measured with a pressure gauge, and the filtration amount Get
It was measured using a graduated cylinder and a stopwatch, and the shear rate was calculated as j = 6Qs/ab'', and the hemoglobin concentration was 2,2',414'-tetramethylben.

It was measured by a conventional method using didine. In addition, pressure loss f Δ
PD was measured using a mercury manometer. Plasma separation efficiency E and membrane efficiency Q- are each based on the following calculation formulas.

QF Hemoglobin concentration change is 50.0■/di or more, plasma separation efficiency is 50% or less, membrane efficiency is 1o, o mt/rrl
Below, the pressure drop change is practically preferably 100■Hf or less@;::,::2f-#tprv@Gstplx!
5K, 4 cases of blood damage such as hemolysis and blood coagulation were found in 8 cases that deviate from the structure of the invention, and even in cases where blood damage was small, sufficient filtration volume could not be obtained or plasma separation efficiency was affected. It is unfavorable in clinical practice, such as poor performance. , LSpecific Effects of the Invention Since the plasma separator according to the present invention has the above configuration, (a) drifting is less likely to occur than when the membrane is rectangular, and (b) blood damage and scratches are less likely to occur. Economical membrane surface '#I in the range where hemolysis and blood coagulation do not occur due to it.
It has the following advantages: (C) It is possible to obtain a sufficient one-time amount with little change in economical performance; (d) It has good separation ability; The main body is a cylindrical case and a lid that is fitted into the case in a liquid-tight manner, and by using an O-ring as a liquid-tight means, it is easy to maintain the cylindrical nurse and the lid in a liquid-tight manner. By pressing the lid and the lid, they can be slid against each other, and the thickness of the blood flow path can be adjusted to a predetermined value.

[Brief explanation of the drawing]

FIG. 1 is an exploded perspective view of a conventional plasma separation device, FIG. 2 is an exploded perspective view of an embodiment of the plasma separation device according to the present invention, and FIG. 3 is a cross-sectional view of the device shown in FIG. 2 in an assembled state. Figures 4 and 5 are cross-sectional views of the flow path regulating plate, - Figure 6 is a cross-sectional view showing another implementation of the apparatus of the present invention, and Figure 7 is a cross-sectional view of a further implementation of the apparatus of the present invention. FIG. 8 is a system circuit diagram showing an example of how the device is used, and FIG. 9 is a graph showing the relationship between shear rate and critical pressure drop for hemolysis. 11.111,211・...Blood inlet, 12,112
゜212...Filtration residual liquid outlet, 13 + 113 *
213...Cylindrical case, 14,114,214 River plate serum outlet, 15,115,215...O ring, 1
6゜116.2161-Lid body-17,117,217・
...Body, 18,118.218...Central opening, 1
9, 119, 219--Plasma passage hole, 20, 120
゜220...Plasma flow path forming member, 21s t 21
b + 121 e221a * 221b ”・Yen W
I filtration membrane, 22,222-p filtration membrane unit), 23.24
...Blood flow path regulating plate, 25...Convex portion, 26,126
, 226...Sealing material. 2nd WA 6 311 Figure 4 5 5th, Figure 6 W! h6Figure 2I5 1 (Figure 8

Claims (1)

[Scope of Claims] 1. (a) It has a circular opening in the center with a diameter of 2 to 8 crn, and is a concentric circle with an outer diameter of lθ to 206y+, and the ratio of the opening diameter to the outer diameter is 1. :2 to 1:5 and a circular filtration membrane having micropores with a pore size of 0.1 to 0.8 microns, and (b) a gap of 50 to 150 microns formed on one side of the filtration membrane. (C) a circular plasma flow path forming member provided on the other surface of the filtration membrane to form a plasma flow path and having a central opening; (d) blood and plasma flowing through the membrane; 2#~60 through sealing material to avoid mixing of
1000 to 800
(e) The plate body thus formed is housed in a main body having a blood inlet, a filtrate residual liquid outlet, and a plasma outlet; f) A liquid path in which the blood injected from the blood inlet passes through the blood flow path, plasma is separated by the filtration membrane, and then reaches the filtration residual liquid outflow port, and the plasma F&separated by the filtration membrane passes through the plasma flow path. A plasma separation device characterized in that a liquid path is formed through a plasma flow path formed by a forming member to a plasma outflow port. 2. The device according to claim 1, wherein the main body includes a cylindrical case and a lid attached to the case in a liquid-tight manner. 3. The device according to claim 2, wherein the lid has liquid-tight means. 4. The device according to claim 3, wherein the liquid-tight means is an O-ring fitted around the peripheral edge of the lid. 5. Claim 1, wherein the plasma flow path forming member is enclosed within two membranes whose inner and outer edges are sealed.
Apparatus according to any one of clauses 4 to 4. 6. (a) It has a circular opening in the center with a diameter of 2 to 8 crn, and is a concentric circle with an outer diameter of 10 to 203, and the ratio of the opening diameter to the outer diameter is 1 = 2 to 1:5. Yes, and the pore diameter is 0.1
A circular filtration membrane with micro pores of ~0.8 microns, (
b) Provided close to one side of the filtration membrane, forming a blood flow path with a gap of 50 to 150 microns between the filtration membrane and having a large number of 8 parts at regular intervals on the surface. and (C) a circular blood flow path regulating plate provided on the other side of the furnace and membrane to form a plasma flow path and having a central opening. (d) through a sealing material to avoid mixing of blood and plasma.
~60 of the above filtration membranes are integrally stacked to make 1000
The total filtration membrane area is ~8000 ci, (e) the six-fingered body thus formed is housed in a main body having a blood inlet, a filtrate residue outlet, and a plasma outlet; (f) I1
11 A liquid path in which blood injected from the liquid inlet passes through the blood flow path, plasma is separated by the filtration membrane, and then reaches the filtration residual liquid outflow port, and plasma filtered and separated by the filtration membrane forms a plasma flow path. Plasma separation device 07, characterized in that a plasma flow path formed by a member forms a liquid path leading to a plasma outflow port, and the blood flow path regulating plate is rigid. Apparatus according to claim 6. 8. The blood flow path regulating plate is flexible and elastic. The device 09 according to claim 6m, the blood flow channel regulating plate is 1. OX 10'~2. OX 1G” dyn
Claim 8 has a Young's modulus of e/cIl.
The equipment described in section. 10. The device according to any one of claims 6 to 9, wherein the convex portion is provided on one side of the blood flow path regulating plate. ]1. The device according to any one of claims 6 to 9, wherein the convex portions are provided at both openings 1t of the blood flow path regulating plate. 12. The distance between the protrusions of the blood flow path regulating plate is 100 to 200
The device according to any one of claims 6 to 11, which has a particle size of 0 micron. 13. The device according to any one of claims 6 to 12, wherein the main body includes a cylindrical case and a lid attached to the nurse in a liquid-tight manner. 14. The device according to claim 13, wherein the lid has liquid-tight means. 15. The device according to claim 14, wherein the liquid-tight means is an O-ring fitted around the peripheral edge of the lid. 16, l111 The device according to any one of claims 6 to 15, wherein the serous flow path forming member is enclosed within a membrane whose inner and outer edges are sealed. .