JPS6099263A - blood processing equipment - 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 Technical Field The present invention relates to a double filtration type blood processing device. In particular, the present invention relates to a double filtration type blood device that enables stable and efficient plasma separation operations.

<Prior Art> In recent years, plasma exchange therapy has been used as a treatment for renal failure, 111 insufficiency, autoimmune diseases, and the like. In this method, the patient's blood is taken out of the body, separated into blood cell components and plasma components, the plasma component is discarded, and the blood cell components and healthy mother's plasma Ab albumin, etc., which are equivalent to the discarded plasma, are separated. , is a method of returning it to the body.

Methods for plasma separation are broadly divided into centrifugal separation methods and membrane separation methods, but in general, the 116) fractional separation method, which can be easily carried out by means similar to hemodialysis, has become popular.

However, since plasma exchange therapy requires a large amount of plasma or other blood products, it not only causes problems of plasma shortage, but also causes problems such as the occurrence of side effects such as hepatitis and high treatment costs. .

In order to eliminate these problems, sometimes in immune-related diseases, only the pathogen-related substances of high molecular weight substances contained in plasma are selectively removed, and low molecular weight substances such as albumin, which are useful components, are removed. Various attempts have been made to return plasma to the body and thereby reduce the amount of plasma injected into the reservoir. Among them, the double filtration plasma separation method is attracting attention.

This method uses two types of filters with different molecular ifi cut-offs, the first filter separates blood cell components and plasma components, and then the plasma components are separated into high molecular weight components by the second filter. In this method, the high molecular weight components are separated into low molecular weight components, and only the high molecular weight components are selectively removed, while the low molecular weight components are returned to the body.

Such a device has already been disclosed in Japanese Patent Application Laid-Open No. 57-22763.
, Japanese Patent Publication No. 57-22764. It is disclosed in Japanese Patent Application Laid-Open No. 57-22765. These devices are intended to automatically control the pressure and flow rate in the circuit during extracorporeal circulation and perform safe and stable double excess separation, but they are not installed in the high molecular weight component discharge circuit. This pump is linked to the pump installed in the plasma extraction circuit of the first filter at a predetermined flow m ratio, and 4 liters of plasma are always pumped out, which reduces the need for replacement fluids such as plasma. It is not necessarily satisfactory in this respect. If an attempt is made to suppress the discharge m, the pressure of blood flowing into the second evaporator will increase, the filter membrane will become clogged, and efficient separation will not be possible.

<Object of the Invention> The present invention (1) provides a blood treatment method for two types of blood that eliminates such drawbacks and allows for more stable and efficient plasma separation operations!
I! The purpose is to change the @ position to jO. In other words,
The present invention stabilizes the operating pressure of the plasma component in the knee 1nlIAi supertype blood processing equipment, and stabilizes the operating pressure of the second ifa filter to reduce the polymeric Li'L component as much as possible.
The aim is to reduce the replacement fluid injection M accordingly.

<Structure of the Invention> As a result of intensive investigation in order to achieve the above object, the inventors found that a pressure nozzle located on the inlet side of the second filter and a second
The present invention has been achieved based on the discovery that it is very effective to maintain a constant relationship between the amount of high molecular weight components extracted from the filter and the discharge amount to the outside of the system.

1'Narichi The present invention comprises (1) a first filtration means for separating blood drawn from the body into blood cell components and plasma components, and further separating the separated plasma components into high molecular weight components and low molecular weight components. and a second filtration means, the blood cell component separated by the first filtration means, the low-molecular m component separated by the second filtration means, and the replacement fluid supplied by the replenishment means are combined to enter the body. In a double filtration type blood processing apparatus having a return means, a pressure detection means for detecting the pressure of the plasma component is provided in the circuit for introducing the plasma component into the second g-filtration means, and the pressure horn is set to a predetermined set pressure. A blood processing device characterized in that the high molecular weight component discharge circuit of the second filtration means is provided with a pump capable of adjusting the flow rate for discharging high molecular weight components, which is controlled in conjunction with the pressure detection means so that the pressure is within a certain range. ;(a
A replacement fluid that is controlled in conjunction with the pump for discharging the high molecular weight component 1 to 1 so that the amount of the replacement fluid introduced into the device of (1) is substantially equal to the amount of the high molecular weight component discharged.゛A pump that can adjust the flow rate for introduction is installed in the replacement fluid introduction circuit.
A hematology device characterized by: (3) the above (2);
In the apparatus of (2) above, the blood processing apparatus is further provided with an installation for heating the plasma component separated by the second filtration means. A portion of the polymer m component is recycled to the inlet circuit of the second filtration means via the filtration means. A blood processing device with a circuit; (5) In the device of (2) above,
The second filtration means is a microporous hollow fiber membrane having anisotropy in which the average pore diameter D+ of the outer surface is smaller than the average pore diameter D2 of the inner surface, and A permselective hollow fiber +1'J having an average pore diameter of 200 to 700 by the passage method is used as a 414 component, and the outside of the hollow fiber membrane is a flow part for the plasma component or the polymer Ω1 component.

A blood processing device in which the inside of the hollow fiber membrane is used as a flow section for low molecular weight components; and (6) above (2], f5).
The present invention provides a blood processing device having the configurations of (3) and/or (4).

FIG. 1 shows one embodiment of the present invention, and its structure and operation will be explained. First, the patient's blood taken out from the blood extraction circuit (1) via the pump (2) is
filter (3). A pressure gauge (4) for monitoring abnormal blood pressure is provided between the '1st filter (3) and the pump (2). This first filter is partitioned by a porous filtration membrane (5) made of cellulose acetate or the like. The plasma component is separated into the blood cell component derivation circuit (7) to the blood cell component derivation circuit (16). A pressure gauge (8) is provided to monitor abnormal pressure relief.

The plasma components separated there are further passed through a second filter (9
), but the pump (6) and the second filter (9)
A pressure gauge 001 that senses the pressure of the plasma introduced into the second filter is provided in the plasma component circuit between the two filters.

The second filter (9) has a filter membrane (
5) is partitioned by a filtration membrane (111) such as cellulose or cellulose, which has a smaller pore size than that of and,
The second filter (9) is separated into a high molecular weight component and a low molecular weight component by pressure based on a flow rate difference between the second filter (9) and the discharge circuit (high molecular weight component discharge pump 03 provided with lz). The separated polymer m component is discharged and passes through circuit 0'2j,
It is discharged into a storage container (3 times). In this case, it is preferable to reduce the polymer m component to a concentration as high as possible before discharging it in order to perform efficient separation and avoid reducing the amount of replacement fluid injected. For this purpose, it is preferable that the pump 03) is not rotated as much as possible. However, in this case, as the filtration in the second filter (9) progresses and the polymer components become concentrated in the second filter (9), the human plasma pressure increases. If this pressure exceeds the set pressure point, the membrane will rapidly become clogged, and not only will filtration become virtually impossible, but there will also be a risk of the filtration membrane bursting, or the circuit becoming disconnected. .

Therefore, in the present invention, a pressure gauge 00) is installed between the pump recorder and the second filter (9) to sense the human blood plasma pressure and perform interlocking control with this pressure gauge. , by automatically changing the rotation speed of the pump 03) or automatically turning the switch ON-OF tL, the flow of the pump a3 is adjusted so that the pressure gauge (g) is within the predetermined force range. It is for adjustment. For example, if the flow rate in the pump record is 20 m1/min, the pressure it aO) is 20~4
The flow rate of the pump 03 is controlled to 0 to 5 m/min so that the set pressure range is 0 mmHg. Therefore, the pressure] fft 00+ is 40 rrm Hg
If G is not exceeded, the pump can remain stopped. 4
If you exceed the Ornm HW, use the pump (
13) automatically rotates to discharge the polymer (6) component and lower the pressure nozzle, thereby preventing clogging of the membrane.

On the other hand, the low-molecular m component separated by the second filter (9) passes through the derivation circuit 05) to the first filtration 2! i(3
After combining with the blood cell components sent from + through the derivation circuit [161], it will be returned to the body of person j&. In addition, in order to supplement the plasma removed by the second filter, a replacement fluid such as fresh frozen plasma or albumin is introduced from the replacement fluid container into the low molecular weight substance deriving circuit 05) through the replacement fluid introduction circuit 081. ing. In the present invention, when introducing this replacement fluid, a replacement fluid introduction pump 09) is provided in the replacement fluid introduction circuit 08). This pump 09) is installed in the polymer component discharge circuit (pump 03), which is linked to control to adjust the flow rate so that the amount of blood removed and the amount of replacement fluid injected are substantially equal. . The interlocking control in this case may be electrical control, but as other means,
It is also possible to use the same driven roller pumps instead of pumps 03) and 09), to use the same internal diameter duplex for the output circuits 02) and 08), and to squeeze them at the same time. This allows the replacement fluid to be injected in just the right amount,
Extracorporeal circulation can be performed stably.

FIG. 2 shows an embodiment of the apparatus shown in FIG. 1 in which a plasma component humidifying means is further provided. The heating means may be provided in the plasma component introduction circuit as shown in FIG. 2, or may be a means for heating the entire second filter.

FIG. 3 shows an embodiment in which, in addition to FIG. 1, a circuit Q9 for partial circulation of the polymeric component (1) and a pump are provided between the plasma component introduction circuit and the polymeric component derivation circuit Q4.

FIG. 4 shows that in FIG. 1, the second filter (9) is a microporous hollow fiber membrane, the average pore diameter D1 on the outer surface is smaller than the average pore diameter D2J on the inner surface. A permselective hollow fiber membrane with anisotropy and an average pore size of 200 to 700 by the water passage method of membrane formation is used as the constituent part, and the outside of the hollow fiber membrane is used as the plasma component. Alternatively, this is an example of an embodiment in which a high-molecular-weight component flows through the hollow fiber membrane, and the inside of the hollow fiber membrane is used as a low-molecular-weight component flows through the flow area.Here, the average pore diameter of the hollow fiber membrane is 200. Low molecular m if less than human
If the permeation rate of components becomes too low and exceeds 700 A, the permeation rate of high molecular weight components becomes too large, making it difficult to separate a given plasma component, which is not preferable.

Further, it is more preferable in terms of separation characteristics that the ratio D2/DI of D1 and D2 is 1.2 or more.

FIG. 5 shows an example of an embodiment in which the above (1) to (4) are combined.

What has been described above is an example of the present invention, but the first filter and the second filter may be hollow fiber type or other types of filters.

In addition, membrane materials for filtration such as hollow fibers include cellulose ester, polyvinyl alcohol, polymethyl methacrylate, polyacrylonitrile, polysulfone, polyvinylidene fluoride, polyamide, and polyester, among which cellulose ester, polysulfur A, polyvinyldenum fluoride, etc. etc. are preferred.

<Effects of the Invention> According to the present invention as described above, when performing double filtration plasma separation, the pressure of plasma introduced into the second filtration means is automatically controlled to be always within a predetermined value range. extremely stable and efficient filtration.
2, and has excellent effects such as being able to minimize the injection of replacement fluid.

In particular, the second filtration means is of a hollow fiber membrane type, and the hollow fibers have anisotropy in which the pore diameter on the outer surface is smaller than the pore diameter on the inner surface, and the low molecular weight components are filtered from the outside to the inside. Transmission μ
In particular, in cases where the plasma component is of the type B, where the plasma component to be separated has a means for humidifying it, where the polymer is a part of the component that circulates, and where all three of these conditions are combined. The separation characteristics of the second filtration means, that is, the permeation rate of low-molecular components, the removal effect of high-molecular components, and the resistance to clogging, etc., have been greatly improved, making the characteristics more effective and stable. can be demonstrated.

[Brief explanation of the drawing]

1 to 5 are schematic diagrams showing embodiments of a double filtration type blood processing neck according to the present invention. In the figure, 2 is a blood extraction pump, 3 is a first filter, 6 is a plasma extraction pump, 9 is a second filter, 12 is a polymer component discharge circuit, 13 is a high molecular weight component discharge pump, and 15 is a low molecular weight component. Component derivation circuit, 18 is a replacement fluid introduction circuit, 19 is a replacement fluid introduction pump, 4.8.10.20 is a pressure gauge, 22 is a heating means,
23 indicates a polymer zero-component circulation pump. Patent Applicant: Teijin Co., Ltd. Company Procedures (Spontaneous) December 1980, 1 Temple, Senchocho Palace 1, Indication of Case Patent Application No. 1984-204.959 No. 2, Name of the Invention Blood processing device 3, relationship with the case of the person making the amendment Representative of the patent applicant Sa Okamoto Part 4 (1) Changed [albumin, etc.] on page 8, line 7 of the specification to "albumin tti". (2) On page 8, line 15, change “at times” to “especially”] Correct J
Ru. (3) Correct the FIL statement on page 9, line 11. (4) 1-pump (O
)” is corrected. (5) "Circuit 02)" of 6 tj from the bottom of page 13
to 1 circuit OZ.'' (6) Pump (6) "Bonzo Roku" on page 14, line 10
)” and corrected it. (7) This is on page 14, bottom line 65. for example"
The range of the predetermined set pressure is determined by the characteristics of the membrane.
-You can choose. For example,” he corrected. (8) “Record flow rate” at the bottom of page 14 of l1i11, line 64
is corrected as "(6) flow rate". (9) 1 polymeric component of Gb et al., page 15, lower h11, [
Corrected to "high molecular weight component." 00) "Polymer weight" on page 16, line 12 is corrected to "polymer ■ component." (11) Correct ``1 Polysulfone'' in line 2 from No. 17 of the same to ``Polysulfone''. that's all

Claims (1)

[Claims] (1) The first step is to separate blood drawn from the body into blood cell components and plasma components! 2i11!, which further separates the separated plasma components into high molecular weight components and low molecular weight components!
said first i! ! The blood cell components separated by the above means and the 211i! ! A circuit for introducing plasma components into the second filtration means in a double filtration type blood processing device having means for combining low molecular weight components separated by the filtration means and replacement fluid introduced by the replenishment means and returning them to the body. is provided with a pressure detection means for detecting the pressure of the plasma component,
A pump for discharging a polymer group component which can adjust the flow rate m controlled in conjunction with the pressure detection means so that the pressure falls within a predetermined set pressure range is connected to the high molecular weight component discharge circuit of the 2'a passing means. A blood processing device characterized by having been installed in ('2J) a first filtration means for separating blood drawn from the body into blood cell components and plasma components; and the second aa, which is separated into low molecular weight components.
means for combining the blood cell components separated by the 1i1a filtration means, the low molecular weight components separated by the 2'a filtration means, and the replacement fluid introduced by the replenishment means and returning them to the body. Double filtration type blood treatment II! In the apparatus, the second i[fl! A pressure detection means for detecting the pressure of the plasma component is provided in the circuit for introducing the plasma component, and the pressure is controlled in conjunction with the pressure detection means so that the pressure falls within a predetermined set pressure range. A pump with an adjustable flow rate m for component discharge is provided in the high molecular weight component discharge circuit of the second filtration means, and the flow rate of the high molecular weight component discharge is adjusted such that the replacement fluid introduction (6) is substantially equal to the flow rate of the high molecular weight component discharge. 1. A blood processing device characterized in that a replacement fluid introduction circuit is provided with a pump that can adjust the flow rate for introducing replacement fluid and is controlled in conjunction with a pump for discharging molecular weight components. (3) A first filtration means for separating blood drawn from the body into a blood cell component and a plasma component, and a second filtration means for further separating the separated plasma component into a high molecular weight component and a low molecular weight component. , a double filtration type having means for combining the blood cell components separated by the first filtration means, the low molecular weight components separated by the second filtration means, and the replacement fluid introduced by the supplementary components and returning them to the body. In blood processing equipment,
A pressure detection means for detecting the pressure of the plasma component is provided in a circuit for introducing the plasma component into the second filtration means, and the pressure is controlled in conjunction with the pressure detection means so that the pressure is within a predetermined set pressure range. A pump capable of adjusting the flow rate for discharging high molecular weight components is provided in the high molecular weight component discharge circuit of the second aa passing means, and the high molecular weight components The replacement fluid introduction circuit is provided with a pump capable of adjusting the flow rate for introducing replacement fluid that is controlled in conjunction with the pump for discharging components, and means for heating the plasma components separated by the second filtration means are provided. A blood processing device characterized by: (4) A first filtration means for separating blood drawn from the body into a blood cell component and a plasma component, and a second filtration means for further separating the separated plasma component into a high molecular weight component and a low molecular weight component. , a double filtration type blood having a means for combining the blood cell components separated by the first filtration means, the low molecular weight components separated by the second m-filtration means, and the replacement fluid introduced by the replenishment means and returning them to the body. In the processing device, a pressure detection means for detecting the pressure of the plasma component is provided in a circuit for introducing the plasma component into the second filtration means, and is interlocked with the pressure detection means so that the pressure falls within a predetermined set pressure range. A pump with an adjustable flow rate for discharging high molecular weight components, which is controlled by a pump, is provided in the high molecular weight component discharge circuit of the second filtration means, and the amount of the replacement fluid introduced is substantially equal to the amount of discharge of the high molecular weight components. A replacement fluid introducing pump capable of adjusting the flow rate controlled in conjunction with the high molecular weight component discharge pump is provided in the replacement fluid introduction circuit, and the second high molecular weight component discharge circuit is connected via the pump to the high molecular weight component discharge circuit of the second filtration means. A blood processing device comprising a circuit for recirculating a part of the polymer group component to the introduction circuit of the filtration means. (5) 1'a filtration means for separating blood drawn from the body into blood cell components and plasma components, and 2i11 for further separating the separated plasma components into high molecular weight components and low molecular weight M components.
6! filtration means, and means for combining the blood cell components separated by the first filtration means, the low molecular weight components separated by the second filtration means, and the replacement fluid supplied by the replenishment means and returning them to the body. In the double filtration type blood processing device, the second filtration means is a microporous hollow fiber membrane, and the average pore diameter D1 on the outer surface thereof is equal to the average pore diameter D1 on the inner surface.
A hollow fiber membrane is used as a component, and the outside of the hollow fiber membrane is A flow part for plasma components or high molecular weight components, the inner side of the hollow fiber membrane is a flow part for low molecular weight components, and the pressure of the plasma components is detected in the circuit that introduces the plasma components into the second filtration means. A pump for outputting high molecular weight component jJ1, which is controlled in conjunction with the pressure detection means, is provided so that the pressure falls within a predetermined set pressure range. A replacement fluid introduction circuit is provided in the molecular group component Sugi 1 output circuit and is controlled in conjunction with the high molecular weight component discharge pump so that the amount of the replacement fluid introduced is substantially equal to the high molecular weight component discharge nostril. A blood processing device characterized in that a pump with adjustable flow rate is installed in a replacement fluid introduction circuit. (6) Comprising a first filtration means that separates blood drawn from the body into blood cell components and plasma components, and a second filtration means that roughly separates the separated plasma components into a high molecular weight component and a low molecular m component. and a double filtration type having a means for combining the blood cell component separated by the first filtration means, the low molecular m component separated by the 28th M filtration means, and the replacement fluid introduced by the replenishment means and returning them to the body. In blood processing equipment,
The second filtration means is a microporous hollow fiber membrane having anisotropy in which the average pore diameter D1 of the outer surface is smaller than the average pore diameter D2 of the inner surface, and the membrane is formed by a water permeation method. A permselective hollow fiber membrane with an average pore diameter of 200 to 700 is used as a constituent member, the outside of the hollow fiber membrane is a flow area for the plasma component or high molecular weight component, and the inside of the hollow fiber membrane is a low molecular weight component. The circuit for introducing the plasma component into the second filtration means is provided with a pressure detection means for detecting the pressure of the plasma component, and the pressure is adjusted within a predetermined set pressure range. A pump with an adjustable flow rate for discharging high molecular weight components, which is controlled in conjunction with the pressure detection means, is connected to the high molecular weight component of the second filter.
A flow rate adjustable flow rate for introducing replacement fluid is provided in the component discharge circuit and is controlled in conjunction with the pump for discharging the high molecular weight component so that the amount of the replacement fluid introduced is substantially equal to the amount of discharge of the high molecular weight component. A pump is provided in the replacement fluid introduction circuit, and means for heating the plasma component separated by the second filtration means and/or an introduction circuit for the second filtration means from the high molecular weight component deriving circuit of the second filtration means via the pump. A blood processing device comprising a circuit for recirculating a portion of the high molecular weight component.