JP2800122B2 - Body fluid filtration device - Google Patents

Description

DETAILED DESCRIPTION OF THE INVENTION [Industrial Application Field] The present invention relates to a bodily fluid filtration device for filtering a bodily fluid with a filtration membrane,
For example, the present invention relates to a plasma separation device that filters blood and separates it into concentrated red blood cells and plasma.

[Related Art] As a bodily fluid filtering device that filters a bodily fluid with a filtration membrane, for example, there is a plasma separating device that filters blood and separates it into blood cells and plasma. As this apparatus, there are a hollow fiber type and a flat membrane type, and a number of membrane materials and shapes have been proposed. The flat membrane type plasma separation device has a wider choice of membrane shape and blood channel shape than the hollow fiber type, and a disk shape (Japanese Patent Application Laid-Open No. 58-50963) and a rectangular shape are proposed. Have been. FIG. 9 shows a cross-sectional view of an example of the plasma separator used in the above-mentioned plasma separator. In FIG. 9, a screen mesh 52 is used as the plasma flow path forming body.
A membrane unit 51 formed by sealing the peripheries of two filtration membranes 51a and 51b sandwiching the membrane unit,
A blood flow path forming body 53 is laminated between the 51 by means of adhesion or compression adhesion through a sealing material 54 arranged around the plasma flow hole 55. The plasma separated by the filtration membrane and flowing into the inside of the membrane unit flows into the plasma flow hole.

The reason why the screen mesh is used as the plasma flow path forming material is that the mesh is a woven fabric made of a yarn having a wire diameter of about 100 μ, so that it is easy to form a void as shown in FIG. Even if a strong compressive force is applied, a sufficient plasma flow path can be secured without crushing the gap.

[Problems to be Solved by the Invention] As shown in Fig. 9, in the conventional plasma separation apparatus, a screen mesh or a plate-shaped resin thin plate has been used as the plasma flow path forming body. However,
In the case of a screen mesh, it is difficult to produce a fiber having a small diameter in production. For this reason, when cutting is performed to obtain a predetermined shape, the cut surface has sharpness and a certain degree of rigidity, which damages the membrane, and there is a problem that blood cells are mixed into the plasma flow path. Further, in the case of a plate-shaped resin thin plate, it is difficult to make the thickness as thin as 0.5 mm or less, and to form the plasma flow path without impairing the uniformity of the blood flow path, so that the apparatus can be downsized. could not.

Further, as shown in FIG. 9, each membrane unit laminated in the plasma separation device is sealed at the plasma flow port portion via a sealing material. For this reason, when an external force is applied in the direction of compressing the membrane unit, the plasma flow path forming body at the position corresponding to the sealing material may lose its escape space and be crushed via the separation membrane. Therefore, there is a problem that the outlet of the plasma flowing through the plasma flow path forming body becomes narrow, and a sufficient amount of plasma cannot be filtered.

Therefore, an object of the present invention is to provide a bodily fluid filtration device that is not likely to damage a bodily fluid filtration membrane by a bodily fluid flow path forming material, and that is smaller and has higher performance than a device using a plate-shaped resin thin plate. With the goal.

Further, the object of the present invention is to use a bodily fluid filtering device, even when the bodily fluid filtering body laminated therein is pressed, without crushing the plasma passage of the filtration channel forming body, having a sufficient bodily fluid filtering ability. An object of the present invention is to provide a body fluid filtering device.

[Means for Solving the Problems] What achieves the above object is a housing having a body fluid inlet, a filtrate outlet, and a filtrate outlet, and a plurality of body fluid filters stacked in the housing. After the body fluid flowing in from the body fluid inlet is brought into contact with the body fluid filter and filtered, the body fluid flow path leading to the filtered residual fluid outlet, and the filtrate separated by the body fluid filter to the filtrate outlet. A filtrate flow path for guiding, the body fluid filter has a filtrate flow path forming body formed of a nonwoven fabric, and a bodily fluid filtration membrane enclosing the filtrate flow path forming body; A bodily fluid flow path forming body is provided between the bodily fluid filtering bodies, and further, the bodily fluid filtering membrane has a protruding portion on a surface, and the bodily fluid flow path forming body has a flat surface. Is a body fluid filtration device.

Further, what achieves the above-mentioned object is a housing having a body fluid inlet, a filtrate outlet, and a filtrate residual solution outlet, and a housing accommodated in the housing, having a filtrate outlet, and a periphery of the filtrate outlet. A plurality of body fluid filters stacked via the provided sealing material, and the body fluid flowing from the body fluid inlet,
A bodily fluid flow path that leads to the filtrate residual liquid outlet after contacting and filtering the bodily fluid filter, and a filtrate flow path that guides the filtrate separated by the bodily fluid filter to the filtrate outlet; The body has a filtrate flow path forming body and a bodily fluid filtration membrane enclosing the filtrate flow path forming body, and further, the filtrate flow path forming body has a plurality of body fluid filtering bodies laminated via a sealing material. A body fluid filter having a reinforcing part formed more rigidly than the other part of the filtrate flow path forming body at a portion pressed by the sealing material through the body fluid filtration membrane when an external force is applied to the body. Device. In addition, in the body fluid filtration device, for example, the body fluid inlet is a blood inlet, the filtrate outlet is a plasma outlet, and the filtration residue outlet is a concentrated red blood cell outlet. Device. Further, the body fluid filter includes a filtrate channel forming body, a body fluid filtering membrane enclosing the filtrate channel forming body, and a body fluid channel forming body provided between the body fluid filtering membranes. Is preferred.

Further, the filtrate channel forming body is preferably formed of a nonwoven fabric, the nonwoven fabric has a thickness of 0.4 mm
The following is preferred. Further, it is preferable that the reinforcing portion is formed of a thermosetting resin. Further, the body fluid channel forming body has, for example, a projecting portion on the surface. The bodily fluid filtration membrane has, for example, a protruding portion on the surface, and the bodily fluid flow path forming body has a flat plate surface.

The body fluid filtering device of the present invention will be described in detail with reference to the drawings.

FIG. 1 is an exploded perspective view showing an embodiment in which the body fluid filtration device of the present invention is applied to a plasma separation device. FIG. 2 is a cross-sectional view of the plasma separation device of FIG.

The body fluid filtration device 1 of the present invention will be described using an embodiment in which the device is applied to the plasma separation device shown in FIGS. 1 and 2.

The plasma separator 1 includes a housing 2 and a plurality of plasma separators 15 forming a body fluid filter stacked in the housing 2.
It consists of

The housing 2 has a cylindrical housing having an inflow port 4 for blood, which is a body fluid to be filtered, an outflow port 3 for concentrated red blood cells, which is residual liquid for filtration, and outflow ports 8a, 8b for plasma, which is filtration. And a bottom plate 9 for sealing the opening. Bottom plate 9
Has an O-ring 10 on the side surface, as shown in FIG. The plasma separator 15 includes a plasma separation membrane 14, a blood flow path forming body 17
And the plasma flow path forming body 13. A circular plasma flow path forming body 13 having an opening 11 communicating with the blood inlet 4 at the center and a plasma outlet 12 communicating with the plasma outlets 8a and 8b in the vicinity of the periphery is formed by two upper and lower circular plasma separation membranes. 14
The peripheral portion and the peripheral portion of the central opening are sealed by heat sealing, bonding, and the like, and a plasma-permeable membrane unit is formed by attaching a sealing material to the outer periphery of the plasma distribution port. ing.

In the present invention, by using a nonwoven fabric as the plasma flow path forming body, the fiber diameter can be reduced, the rigidity of the cut surface is reduced, and it is possible to prevent the plasma separation membrane from being damaged.

As the material of the nonwoven fabric, a material formed of synthetic fibers such as polyester, nylon, and polypropylene is preferable. Further, as for the type of the nonwoven fabric, a non-binder type, for example, a nonwoven fabric formed by a mechanical bonding method (needle punching method, stitch method) or a heat bonding method (columnar flow) in consideration of contact with body fluids A method formed by a processing method or a method of fusing the web itself by heat) is preferable. And the plasma flow path forming body,
It may be formed of one nonwoven fabric, but preferably
It is preferable to form a plurality of nonwoven fabrics by stacking a plurality of nonwoven fabrics. By stacking a plurality of nonwoven fabrics, voids are easily formed between the nonwoven fabrics, and the flow resistance of plasma can be reduced.
The thickness of the nonwoven fabric layer (plasma channel forming body) is preferably from 100 to 400 μm. If it is 100 μm or more, the resistance of the plasma for flowing through a portion other than the vicinity of the plasma flow hole can be sufficiently reduced, and sufficient plasma separation ability can be obtained. If the thickness is 400 μm or less, the size of the device can be sufficiently reduced.

Further, the plasma flow path forming body is particularly provided with a sealing material so that a plasma flow path can be sufficiently secured and sufficient plasma separation ability can be maintained even when a compressive force is applied in the vertical direction. It is preferable that the plasma flow path forming body is not collapsed around the flow hole.

As in the case of FIG. 9 described above, also in the case of FIG. 3, each membrane unit laminated in the plasma separation device is sealed via a sealing material at the plasma flow port. . For this reason, when an external force is applied in the direction of pressing the membrane unit, the plasma flow path forming body at a position corresponding to the sealing material is pressed via the separation membrane. And the second
As shown in FIG. 3, FIG. 3, FIG. 4 and FIG. 5, when an external force is applied in the direction of pressing the membrane unit, which is a part of the plasma flow path forming body, around the plasma flow hole and the body fluid filter. In the part of the part pressed by the sealing material via the separation membrane,
It is preferable to provide a reinforcing portion 22 that is reinforced (hardened) from other portions of the plasma flow path forming body. This reinforcement
By providing the nonwoven fabric, even if a compression force (pressing force) is applied without giving the nonwoven fabric a sufficient thickness, the
The blockage of the plasma channel due to the collapse of the nonwoven fabric 13 in the vicinity can be prevented, and good plasma separation ability can be obtained. As shown in FIGS. 4 and 5, the reinforcing portion 22 has a portion near the periphery of the plasma distribution port 12 of the nonwoven fabric 13 and a portion (reinforcement portion 22) sufficient to allow the plasma to flow through the plasma distribution port without difficulty. ) May be of any shape as long as the remaining portion is left. Preferably, 1/2 of the periphery of the plasma flow port
11/10, more preferably 1/3 to 1/5. In particular, the fourth
In the embodiment shown in FIG. 5 and FIG. 5, three reinforcing portions 22 are provided at equal positions on the periphery of the plasma distribution port 12. In addition, as shown in FIGS. 6 and 7, the reinforcing portion 22 may be provided at a position slightly inside rather than at the peripheral edge of the plasma distribution port 12. Then, the reinforcing portion 22 is provided on a part of the plasma flow path forming body 13,
It is preferable to form by impregnating and curing a thermosetting resin. As the thermosetting resin, polyurethane resin, epoxy resin, silicone resin and the like can be preferably used. Further, the reinforcing portion may be provided partially on a portion other than the periphery of the plasma distribution port 12. However, since there is a space for the blood flow path formed between the membrane units in a portion other than the vicinity of the plasma flow port (that is, a portion other than the position adjacent to the sealing material),
Even when an external force is applied, the plasma flow path forming member is not easily crushed.

And, between the plurality of plasma separation membrane units, there is provided a central opening 11 and a plasma distribution port 12 corresponding to each unit, and a circular blood flow path forming body having a large number of projections on both surfaces.
17 are arranged. Further, a circular shape having a central opening of the separation membrane unit and an opening corresponding to the plasma flow opening and a flow opening at the upper and lower portions of the plasma separation membrane unit and having a large number of convex portions on one surface. Blood flow path forming body
18 is in contact with the projection so that the projection contacts the separation membrane unit. A plasma separator 15 is formed by the plasma separation membrane unit and the blood flow path forming body. A plurality of sets of plasma separators 15 are overlapped and inserted into the housing 2, the bottom plate 9 is pressed and fitted into the housing 6, and the O-ring 10 is made liquid-tight. Further, by the above-described pressing, the plasma separation membrane unit and the blood flow path regulator are liquid-tightly connected by the seal member 16 at the outer peripheral portion of the flow opening, and the flow openings communicate with each other.

Therefore, in the plasma separator 1, the blood flowing from the blood inlet 4 of the housing 2 flows between the plasma separation membrane 14 and the blood flow path forming members 17 and 18, and the body fluid flowing to the blood outlet 3 The blood flow, which is a blood flow path, and the blood plasma filtered by the plasma separation membrane 14 flow through the inner surface of the plasma separation membrane, the inner surface of the plasma flow path forming body 13, and the plasma flow, which is a filtrate flow path reaching the plasma outlets 8a, 8b. A road is formed.

As the plasma separation membrane 14, a cellulose ester such as an organic acid ester such as cellulose nitrate or cellulose acetate, or a synthetic resin membrane (thickness: 30 to 200 μm) such as polypropylene, polyethylene, or polycarbonate is subjected to a phase separation method, an extraction method, and a stretching method. Method, a film formed by a known method such as charged particle irradiation method, the average pore diameter of which is about 0.1 to 1 μm, preferably
It is 0.1 to 0.8 μm.

The plasma separation membrane 14 has a circular opening of 1.5 to 5 cm in diameter, preferably 2 to 3 cm in the center, and an outer diameter of 8 to 15 cm.
It is preferably a concentric circle of 10 to 12 cm, and the ratio of the diameter of the opening to the outer diameter is preferably 1: 3 to 1: 6.

The blood flow path forming bodies 17 and 18 form a blood flow path with the plasma separation membrane 14, and have a large number of projections. Its Young's modulus is 1.0 × 10 ^{4 to} 2.0 × 10 dyne / cm ² , and preferably 1.0 × 10 ⁴ to 1.0 × 10 dyne / cm ² . The reason is that when the separator is pressed to narrow and relax the blood flow path, the flow path is plastically self-restored, and a desired filtration membrane is easily obtained. Examples of the material having a Young's modulus in this range include low-density polyethylene, silicone, isoprene rubber, butyl rubber, styrene-butadiene rubber (SBR), and ethylene-vinyl acetate copolymer resin (EVA). Further, it is desirable that the surface hardness of the blood flow path forming body provided with the convex portion has a Shore A hardness of 10 to 100. The projections of the blood flow path forming bodies 17 and 18 support the plasma separation membrane 14 here to prevent deformation, and secure a blood flow path in the gap between the projections. The height of the projection is preferably 50 to 500 μm, particularly 100 μm.
~ 250 µm is preferred. The reason is that when the thickness is 50 μm or more, the thickness of the flow channel can be adjusted relatively easily, and when it is 500 μm or less, it is preferable because the deformation is small, errors hardly occur, and the shear rate can be increased. In addition, the interval between the bottoms of these projections is 100 to 2,000 μm.
Is particularly preferable, and particularly preferably 400 to 800 μm. Further, the ratio of the radius of the bottom of the projection, the length of the diagonal line or one side, and the distance between the projections is desirably 1: 1 to 1: 3.

Further, as another embodiment of the plasma separator 1, for example,
Those shown in FIG. 3 are also preferable. The difference between the embodiment shown in FIG. 3 and that shown in FIG. 1 lies in the configuration of the plasma separator.

In this embodiment, a circular plasma flow path forming body 17 made of a nonwoven fabric having an opening 11 in the center and a plasma flow opening 12 in the vicinity of the periphery, and the protruding portion 14a of the plasma separation membrane 14 is on the blood flow side. Thus, the membrane unit is formed by sandwiching the two plasma separation membranes 14 and sealing the peripheral edge and the peripheral edge of the central opening. And, between the membrane units, a plate-shaped blood flow path forming body 17 in which a sealing material 16 is adhered to a central opening corresponding to the unit and a plasma flow port and an outer periphery of the plasma flow port is provided, and a seal is provided. Material 16 and membrane unit and blood flow path forming body
17 is in a liquid-tight state.

The protruding portion 14a of the plasma separation membrane 14 supports the plasma separation membrane by the blood flow path forming body 17 provided thereon to prevent deformation, and allows blood to flow through the gap between the protruding portions 14a. To secure the road. This protruding portion 14a has a height H of 2
Preferably, 0 to 200 μm, the bottom diameter R is 100 to 1000 μm, the distance D between the vertices of the projection is 300 to 2000 μm, and the area occupied by the projection on the entire film surface is 3 to 20%. More preferably, the height H is 50 to 100 μm, and the bottom diameter R is 200 to 100 μm.
It is desirable that the protrusion D has an apex D of 500 to 1000 m and the protrusion occupies 5 to 15% of the entire film surface. The plate-shaped blood flow path forming body 17 is preferably made of a hard material having a Brinell hardness (JISZ2243) of 10 or more and having a thickness T of 10 to 200 μm, more preferably 20 to 50 μm. Materials having a Brunel hardness in this range include polyethylene, polypropylene, polyester, polycarbonate and the like. The circular filtration membrane 14 has a diameter of 1.5 to 5 cm in the center, preferably 2 to 3 c.
m with a circular opening and an outer diameter of 8-15 cm, preferably 10
~ 12cm concentric circle, the ratio of opening diameter to outer diameter is 1: 3 ~
Preferably it is 1: 6.

Further, as the plasma channel forming member 13, the above-described ones can be suitably used.

By using a plasma separation membrane having a protrusion on the surface as described above, and further using a flat plate as the blood flow path forming body, the plasma separation body can be reduced in size. The size can be reduced. Therefore, a plasma separation device having a small priming volume can be provided. Further, a hard blood flow path forming body is provided on the upper part of the plasma separation membrane with protrusions, and by setting the shape of the protrusions as described above, a highly uniform and stabilized thin-layer blood flow path can be formed. And high plasma separation performance is obtained.

In the above description, as an example of a body fluid filtration device, an embodiment applied to a plasma separation device has been described. However, the present invention is not limited to this, and is applied to, for example, a device for removing pathogenic macromolecules from plasma components, a device for removing medium molecular weight substances, and the like. it can.

[Operation] Next, an embodiment in which the operation of the body fluid filtration device of the present invention is applied to a plasma separation device will be described with reference to FIGS. 1, 2 and 8. FIG. 8 is a circuit diagram showing an extracorporeal circulation circuit to which a plasma separation device is attached.

Blood removed from the human body or a blood container (not shown) is introduced from a circuit inlet 30 by a liquid feed pump 31, passes through a chamber 32, and is introduced from a blood inlet 4 of the plasma separation device 1. The blood that has flowed into the plasma separation device 1 is filtered while flowing through a blood flow path formed between the plasma separation membrane 14 and the flow path regulator 17 shown in FIG. Then, the blood flows through the plasma flow path forming body 13, passes through the plasma flow opening 12, and flows out of the plasma outlets 8 a and 8 b. The outflowing plasma is collected in the plasma collection container 35 while being controlled by the filtration body fluid pump 34. On the other hand, the concentrated red blood cells, which are the residual liquid after filtration, are discharged from the blood outlet 3 and returned to the human body or the blood container through the chamber 36 from the circuit outlet 37. 38 and 3 in the figure
9,40 is a pressure gauge.

[Example] Hereinafter, an example of the present invention will be described.

(Example 1) As a plasma separation membrane, a circular polypropylene filtration membrane (average pore diameter: 0.6 μm, film thickness: 130 μm, outer diameter: 100 mm, central opening diameter: 20 mm, diameter: 15 mm from the outer periphery, 6 mm in diameter at the center
m having two openings at opposite positions). As the plasma channel forming body, the basis weight is 15 g / m ² , and the thickness is 150
μm, outer diameter 94 mm, central opening diameter 26 mm, polypropylene non-woven fabric with a 6 mm diameter plasma outlet at a distance of 12 mm from the outer periphery (polypropylene spun-pound non-woven fabric, manufactured by Mitsui Petrochemical Co., Ltd. Mein Shintex PK-10
3), further, around the plasma flow hole, as shown in FIG. 4 and FIG. One having two reinforcing members was used.
Then, the above-mentioned plasma flow path forming body was sandwiched between two separation membranes, and the outer peripheral portion and the central opening of the separation membrane were heat-sealed to produce a membrane unit. As the blood flow path forming body, the surface (front and back) has a height of 120 μm and a diameter of 3
A 1-mm-thick polypropylene member having a large number of protrusions of 00 μm at regular intervals was used. The membrane unit and the blood flow path forming body are alternately laminated using a hot-melt adhesive as a sealing material. On the upper and lower surfaces of the membrane unit, a convex portion having a height of 120 μm and a diameter of 300 μm is provided only on one surface. A blood flow path forming body made of polypropylene having a thickness of 1 mm and having a large number at regular intervals was provided to prepare a plasma separator. As the housing, a polycarbonate cylindrical housing (outer diameter 112 mm, inner diameter 106 mm, depth 38 mm) has a blood inlet (inner diameter 5 mm) at the center of the upper surface, and two plasma outlets (inner diameter 5 mm).
mm) and a housing provided with a blood outlet having an inner diameter of 5 mm on the side wall of the housing.

Then, after storing the plasma separator in the housing, a bottom plate made of polycarbonate having an O-ring made of silicone rubber was inserted into the side surface, thereby producing the plasma separator of the present invention. The effective membrane area of this plasma separation device was 0.35 m ² .

(Example 2) As a plasma separation membrane and a plasma channel forming member, Example 1 was used.
The same thing as the above was used.
g / m ^2, using an overlay two sheets of polypropylene nonwoven fabric having a thickness of 430 m (which was not the creation processing of the reinforcing portion around the plasma flow holes) to form a membrane unit. As the housing, a polycarbonate cylindrical housing (112 mm outer diameter, 106 mm inner diameter, 45 mm depth) has a blood inlet (5 mm inner diameter) at the center of the upper surface, two plasma outlets (5 mm inner diameter), and a housing. A tube provided with a blood outlet having an inner diameter of 5 mm on the cylinder wall was used. The effective membrane area of this plasma separator is 0.35
It was m ^2. In the apparatus of the second embodiment, the thickness of the
20% increase in priming volume and 15% increase in priming volume.

(Example 3) As a plasma separation membrane, a circular polypropylene filtration membrane (average pore diameter: 0.6 μm, film thickness: 130 μm, outer diameter: 100 mm, central opening diameter: 20 mm, diameter: 6 mm at a position 15 mm away from the outer circumference at the center)
Surface with two m openings facing each other (front only)
Having a large number of protrusions having a height of 80 μm and a diameter of 300 μm at regular intervals). The blood flow path forming body is made of polycarbonate and has a flat plate-like surface with a diameter of 100 mm and a thickness of 50 mm.
μm was used. The same membrane unit as in Example 1 was prepared as the plasma channel forming body. The membrane unit and the blood flow path forming body were alternately laminated using a hot-melt adhesive as a sealing material to prepare a plasma separator.
As the housing, a cylindrical housing made of polycarbonate (outer diameter 112 mm, inner diameter 106 mm, depth 20 mm), blood inlet (inner diameter 5 mm) in the center of the upper surface, and two plasma outlets (inner diameter 5 m)
m) Further, a housing provided with a blood outlet having an inner diameter of 5 mm on the cylindrical wall of the housing was used. The effective membrane area of this plasma separator was 0.30 m ² . In the device of Example 3, the thickness was reduced by 45% and the priming amount was reduced by 30% as compared with the device of Example 1.

(Comparative Example) The same housing as that in Example 1 was used.

The membrane unit consists of two circular polypropylene filtration membranes (average pore diameter: 0.6 μm, film thickness: 130 μm, outer diameter: 100 mm, central opening: 20 mm, 15 mm from the outer periphery, and a distance of 15 mm from the center. 240 μm, 240 μm thick as plasma channel forming body
m, outer diameter 94mm, central opening 26mm, two polyester screen meshes with two openings 6mm inside at a position spaced 12mm from the outer periphery at the center of the outer periphery and center of the separation membrane The opening was made by heat sealing. As the blood flow path forming body, a 1 mm thick polypropylene sheet having a large number of convex portions having a height of 120 μm and a diameter of 300 μm at regular intervals on its front surface (front and back surfaces) was used. The membrane unit and the blood flow path forming body are alternately laminated using a hot-melt adhesive as a sealing material. On the upper and lower surfaces of the membrane unit, a convex portion having a height of 120 μm and a diameter of 300 μm is provided only on one surface. A plasma separator of a comparative example was prepared using a plasma separator having a large number of 1 mm-thick polypropylene blood flow path forming bodies provided at regular intervals. The effective membrane area of this plasma separator is
0.35 m ² .

(Experiment) ACD-added bovine blood having a hematocrit value of 40% and a temperature of 37 ° C. was flowed at a flow rate of 100 ml / min using the plasma separators of Examples 1, 2, 3 and the comparative example. Plasma separation was performed under the conditions, and the plasma filtration amount QF was measured.

As a result, in Example 1, QF was 35 ml / min, in Example 2, QF was 33 ml / min, in Example 3, QF was 38 ml / min, and in Comparative Example, it was 35 ml / min. Further, in the plasma separation device of the comparative example, urgent mixing into plasma, which is considered to be caused by damage to the plasma separation membrane, occurred in 2 out of 25 cases. In the plasma separation devices of Examples 1, 2, and 3, no blood cells were mixed in the plasma (filtrate).

[Effect of the Invention] The bodily fluid filtering device of the present invention includes a bodily fluid inlet, a filtrate outlet,
A housing having a filtration residual liquid outlet, a plurality of bodily fluid filters stacked in the housing, and a bodily fluid flowing from the bodily fluid inflow port being brought into contact with the bodily fluid filter and filtered, and then the filtration residual liquid is removed. A bodily fluid flow path leading to an outlet, and a filtrate flow path that guides the filtrate separated by the bodily fluid filter to the filtrate outflow port, wherein the bodily fluid filter is a filtrate flow path formed body formed of a nonwoven fabric, A bodily fluid filtration membrane enclosing the filtrate channel forming body, wherein a bodily fluid channel forming body is provided between the stacked plurality of bodily fluid filtering bodies, and further, the bodily fluid filtering membrane has a surface. Since the surface of the body fluid flow path forming body has a flat plate shape, the end of the nonwoven fabric does not damage the body fluid separation membrane. Prevents blood cells from entering the plasma due to damage to the filtration membrane Door can be.

Furthermore, the bodily fluid filtration device of the present invention has a housing having a bodily fluid inlet, a filtrate outlet, and a residual filtrate outlet, and a housing accommodated in the housing and having a filtrate flow opening, and a periphery of the filtrate flow opening. A plurality of body fluid filters stacked via the provided sealing material, and the body fluid flowing from the body fluid inlet,
A bodily fluid flow path that leads to the filtrate residual liquid outlet after contacting and filtering the bodily fluid filter, and a filtrate flow path that guides the filtrate separated by the bodily fluid filter to the filtrate outlet; The body has a filtrate flow path forming body and a bodily fluid filtration membrane enclosing the filtrate flow path forming body, and further, the filtrate flow path forming body has a plurality of body fluid filtering bodies laminated via a sealing material. When an external force is applied to the portion, which is pressed by the sealing material through the bodily fluid filtration membrane, has a reinforcing portion formed more hard than the other portion of the filtrate flow path forming body. In use, even when the body fluid filter is pressed during use, the filtrate flow path forming body in the portion where the sealing material is located has a reinforcing portion, so it is difficult to collapse, and the filtrate flow path is reliably maintained, so it is sufficient. With excellent body fluid separation ability and thin wall Because things can be used, it is also possible to miniaturize the apparatus.

[Brief description of the drawings]

FIG. 1 is an exploded perspective view showing one embodiment of the bodily fluid filtering device of the present invention, FIG. 2 is a cross-sectional view of the bodily fluid filtering device shown in FIG. 1, and FIG. FIG. 4 is a partial cross-sectional view of another embodiment of the bodily fluid filtering device, FIG. 4 is a partially enlarged view showing an example of a filtrate flow path forming body used in the bodily fluid filtering device of the present invention, and FIG. FIG. 6 is a partial cross-sectional view of the filtrate flow path forming body shown in FIG. 4, FIG. 6 is a partially enlarged view showing another example of the filtrate flow path forming body used in the present invention, and FIG. And FIG. 6 is a partial cross-sectional view of the filtrate flow path forming body shown in FIG. 6, FIG. 8 is a circuit diagram for explaining the operation of the body fluid filtering device of the present invention, and FIG. It is an expanded sectional view of the plasma separator used for the apparatus. DESCRIPTION OF SYMBOLS 1 ... Plasma separator, 2 ... Housing 3 ... Blood outlet 4 ... Blood inlet 8a, 8b ... Plasma outlet, 9 ... Bottom plate 10 ... O-ring, 13 ... Plasma channel formation Body 14: Plasma separation membrane, 15: Plasma separator, 16: Seal material, 17: Blood flow regulator 22: Reinforcing part

Claims (9)

(57) [Claims] 1. A housing having a body fluid inlet, a filtrate outlet, and a filtrate residual solution outlet, a plurality of body fluid filters stacked in the housing, and a body fluid flowing from the body fluid inlet. After contacting and filtering the filter body, a body fluid flow path leading to the filtration residual liquid outlet, and a filtrate flow path leading the filtrate separated by the body fluid filter to the filtrate outlet,
The body fluid filter includes a filtrate channel forming body formed of a nonwoven fabric and a bodily fluid filtration membrane enclosing the filtrate channel forming body, and a bodily fluid flow is provided between the plurality of stacked body fluid filters. A channel forming body is provided, further, the body fluid filtration membrane has a protruding portion on a surface, and the body fluid channel forming body has a flat surface. Filtration device. 2. A housing having a body fluid inlet, a filtrate outlet, and a filtrate outlet, and housed in the housing,
A plurality of bodily fluid filters, each having a filtrate flow port, stacked through a sealant provided on the periphery of the filtrate flow port, and contacting the bodily fluid flowing from the bodily fluid inflow port with the bodily fluid filter to filter the bodily fluid. After that, a bodily fluid flow path leading to the filtration residual liquid outlet,
A filtrate channel for guiding the filtrate separated by the body fluid filter to the filtrate outlet, the body fluid filter comprising a filtrate channel forming member and a bodily fluid filtration membrane enclosing the filtrate channel forming member; Further, the filtrate flow path forming body is pressed by the sealing material through the bodily fluid filtration membrane when an external force that presses the plurality of bodily fluid filtration bodies stacked via the sealing material is applied. A bodily fluid filtration device comprising a reinforcing portion formed in a portion more rigidly than other portions of the filtrate flow path forming body. 3. The body fluid filtering device according to claim 2, wherein the reinforcing portion is formed of a thermosetting resin. 4. The bodily fluid filtering device according to claim 2, wherein the bodily fluid filtering device includes a bodily fluid flow path forming member provided between a plurality of stacked bodily fluid filtering media. 5. The bodily fluid filtration device according to claim 4, wherein the bodily fluid flow path forming body has a projecting portion on a surface. 6. The bodily fluid filtration device according to claim 4, wherein the bodily fluid filtration membrane has a protruding portion on the surface, and the bodily fluid flow path forming body has a flat surface. 7. The body fluid filtering device according to claim 2, wherein the filtrate flow path forming body is formed of a nonwoven fabric. 8. The body fluid filtration device according to claim 1, wherein the nonwoven fabric has a thickness of 0.4 mm or less. 9. The body fluid filtering device, wherein the body fluid inlet is
The bodily fluid filtration according to any one of claims 1 to 8, wherein the filtration device is a blood inlet, the filtrate outlet is a plasma outlet, and the filtration residue outlet is a concentrated red blood cell outlet. apparatus.