# US 4,397,747 A · Apparatus for plasma separation/exchange by double filtration

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- Number: US 4,397,747 A
- Document ID: US4397747A
- Status: Granted
- Kind: A
- Application number: 06/283,227
- Filed: 1981-07-14
- Granted: 1983-08-09
- Earliest claimed: 1980-07-18
- Assignees: Kawasumi Laboratories, Inc.; Kuraray Co., Ltd.
- Inventors: Saburo Ikeda
- Web page: https://patentgrep.com/patent/US4397747A

## CPC

- A61M 1/3624: {Level detectors; Level control}
- A61M 1/3472: {with treatment of the filtrate}
- A61M 1/3482: {by filtrating the filtrate using another cross-flow filter, e.g. a membrane filter}
- A61M 2205/3382: Upper level detectors
- A61M 2205/3386: Low level detectors
- A61M 2205/705: Testing of filters for leaks
- A61M 2205/707: Testing of filters for clogging
- A61M: DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY (introducing media into or onto the bodies of animals A61D7/00; means for inserting tampons A61F13/26; devices for administering food or medicines orally A61J; containers for collecting, storing or administering blood or medical fluids A61J1/05); DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY (surgery A61B; chemical aspects of surgical articles A61L); DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR {(Electrotherapy, e.g. producing anaesthesia by the use of alternating or intermittent currents A61N1/36021)}

## Abstract

The invention provides an apparatus for plasma separation/exchange by double-step-membrane filtration, namely separation of blood into plasma and a corpuscular fraction and separation of high-molecular-weight substances (e.g. gamma-globulin) in the plasma from low-molecular-weight substances (e.g. albumin), and addition of a substitute fluid. A method of treating blood is also provided. The apparatus and method are effective e.g. in the treatment of blood of patients with peripheral circulatory insufficiency due to arteriosclerosis and of patients with rheumatoid arthritis, which is an autoimmune disease.

## Claims

### Claim 1

An apparatus for plasma separation and exchange utilizing double filtration comprising:
a first filter means for separating the blood withdrawn from a patient's body into a corpuscular fraction and a plasma fraction;
a second filter means for receiving the plasma fraction from said first filter means for separating said plasma fraction further into a high-molecular-weight fraction and a low-molecular-weight fraction containing albumin;
means to combine said corpuscular fraction from said first filter means with said low-molecular-weight fraction from said second filter means;
means for adding an additional fluid to the combined corpuscular and low-molecular-weight fractions;
a plasma reservoir between said first and second filter means for receiving said plasma fraction from said first filter means on its way to said second filter means, said reservoir having an opening which is vented to the atmosphere;
level sensing means for monitoring the plasma level within said plasma reservoir;
a first pump means controlled in association with said level sensing means for adjusting the flow rate of plasma between said first and second filter means for maintaining the plasma level in said reservoir within a predetermined range;
a second pump means for controlling, in association with said first pump means, the flow rate of said high-molecular-weight fraction exiting from said second filter means for maintaining the flow rate ratio between the plasma entering said second filter means and the high-molecular-weight fraction withdrawn therefrom at a predetermined value; and
a third pump means for controlling, in association with said second pump means, the flow rate of additional fluid provided by said adding means so that the amount of high-molecular-weight fraction withdrawn from said second filter means is equal to the amount of additional fluid added by said adding means.

### Claim 2 (depends on 1)

The apparatus of claim 1 further comprising a sterilizing filter attached to the opening in the plasma reservoir.

### Claim 3 (depends on 1)

The apparatus of claim 1 wherein said level sensing means comprises ultrasonic wave transmitting and receiving means.

### Claim 4 (depends on 1)

The apparatus of claim 1 wherein said level sensing means comprises light emitting and light sensing means.

### Claim 5

A method for separating and exchanging blood plasma comprising:
separating the blood withdrawn from a patient's body into a corpuscular fraction and a plasma fraction in a first filter;
passing said plasma fraction through a plasma reservoir, vented to the atmosphere, on its way to a second filter;
separating said plasma fraction further into a high-molecular-weight fraction and an albumin-containing low-molecular-weight fraction in said second filter;
combining said corpuscular fraction from said first filter with said low-molecular-weight fraction from said second filter;
adding an additional fluid to the combined corpuscular and low-molecular-weight fractions in an amount equal to the amount of high-molecular-weight fraction separated from said plasma fraction in said second filter;
monitoring the plasma level within said plasma reservoir;
maintaining said plasma level within a predetermined range by adjusting the flow rate of plasma between said first and second filters in response to the monitored level of plasma within said plasma reservoir; and
maintaining the flow rate ratio between the plasma entering said second filter and the high-molecular-weight fraction withdrawn therefrom at a predetermined value by controlling the flow rate of the high-molecular-weight fraction exiting from said second filter.
