# US 7,407,742 B2 · Plasma or serum separator, plasma or serum sampling method, plasma or serum separating method, test carrier and glass fiber

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- Number: US 7,407,742 B2
- Document ID: US7407742B2
- Status: Granted
- Kind: B2
- Application number: 10/505,557
- Filed: 2003-02-25
- Published: 2005-05-19
- Granted: 2008-08-05
- Earliest claimed: 2002-02-27
- Assignees: Sanko Junyaku Co., Ltd.
- Inventors: Eiji Ikeda
- Web page: https://patentgrep.com/patent/US7407742B2

## CPC

- G01N 33/491: {by separating the blood components (G01N15/05 takes precedence)}
- B01L 3/502: {with fluid transport, e.g. in multi-compartment structures}
- G01N: INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES (measuring or testing apparatus or processes other than immunoassay, involving enzymes or microorganisms C12M, C12Q)
- B01L: CHEMICAL OR PHYSICAL LABORATORY APPARATUS FOR GENERAL USE

## Abstract

Provided are a plasma or serum separator and a plasma or serum sampling method capable of isolating plasma or serum with good efficiency from a small amount of blood without using a centrifuge and without causing leakage of a blood cell component or hemolysis, and in addition, capable of isolating and collecting plasma or serum from a whole blood test sample in a short time with simplicity in a blood test in the scene of medical care requiring an instant treatment any time such as an emergency test, home-use test or the like. The plasma or serum separator for isolating plasma or serum from whole blood comprises: a blood separation member, a holding member covering and holding the blood separation member; a blood introducing portion formed in a portion of the holding member covering a proximal end portion of the blood separation member; and a plasma or serum sampling aperture formed in a portion of the holding member covering a distal end portion of the blood separation member, wherein the whole blood is introduced into the blood separation member through the blood introducing portion, the introduced whole blood is separated such that the plasma or serum is located in the distal end portion of the blood separation member, while blood cells are located in the proximal end portion of the blood separation member; thereby enabling the plasma or serum located in the distal end portion of the blood separation member to be sampled through the plasma or serum sampling aperture.

## Claims

### Claim 1

A plasma or serum separator for isolating plasma or serum from whole blood, said separator comprising:
a blood separation member,
a holding member covering and holding the blood separation member;
a blood introducing portion formed in a portion of the holding member covering a proximal end portion of the blood separation member; and
a plasma or serum sampling aperture formed in a portion of the holding member covering a distal end portion of the blood separation member,
wherein the whole blood is introduced into the blood separation member through the blood introducing portion, and the introduced whole blood is separated such that the plasma or serum is located in the distal end portion of the blood separation member, while blood cells are located in the proximal end portion of the blood separation member; thereby enabling the plasma or serum located in the distal end portion of the blood separation member to be sampled through the plasma or serum sampling aperture,
wherein the blood separation member is made of a fibrous material and/or a porous material, and
wherein the fibrous material and/or the porous material (A) is one kind or two or more kinds selected from the group consisting of glass fibers, non-woven fabrics, cellulose fibers, polyester, polypropylene, polyamide, polyethylene, polyurethane and polyvinyl formal, and (B) is coated with propanol with a butoxy group and/or acrylamide with a butoxy group.

### Claim 2 (depends on 1)

The plasma or serum separator according to claim 1, wherein the fibrous material is glass fibers.

### Claim 3 (depends on 1)

The plasma or serum separator according to claim 1, wherein the propanol with butoxy is butoxypropanol.

### Claim 4 (depends on 1)

The plasma or serum separator according to claim 1, wherein the acrylamide with a butoxy group is butoxymethylacrylamide.

### Claim 5 (depends on 1)

The plasma or serum separator according to claim 1, wherein the holding member is a transparent or semi-transparent liquid non-penetrable film.

### Claim 6 (depends on 1)

The plasma or serum separator according to claim 1, wherein the blood introducing portion is covered with a network member capable of being penetrated by blood.

### Claim 7 (depends on 1)

A plasma or serum sampling method employing a plasma or serum separator according to claim 1, said method comprising the steps of:
sticking a needle-like tool in a blood sampling portion to cause the portion to bleed;
bringing the blood introducing portion of the plasma or serum separator into contact with the bleeding site to introduce whole blood into the blood separation member;
subjecting the introduced whole blood to separation by the blood separation member such that the plasma or serum is located in the distal end portion thereof, while blood cells are located in the proximal end portion thereof; and
sampling plasma or serum staying in the distal end portion of the blood separation member through the plasma or serum sampling aperture.

### Claim 8 (depends on 7)

The plasma or serum sampling method according to claim 7, wherein the fibrous material is glass fibers.

### Claim 9 (depends on 7)

The plasma or serum sampling method according to claim 7, wherein the propanol with a butoxy group is butoxypropanol.

### Claim 10 (depends on 7)

The plasma or serum sampling method according to claim 7, wherein the acrylamide with a butoxy group is butoxymethylacrylamide.

### Claim 11 (depends on 7)

The plasma or serum sampling method according to claim 7, wherein the holding member is a transparent or semi-transparent liquid non-penetrable film.

### Claim 12 (depends on 7)

The plasma or serum sampling method according to claim 7, wherein the blood introducing portion is covered with a network member capable of being penetrated by blood.

### Claim 13

A plasma or serum separator for isolating plasma or serum from whole blood, said separator comprising a blood separation member having a fibrous material and/or a porous material coated with propanol with a butoxy group and/or acrylamide with a butoxy group.

### Claim 14 (depends on 13)

The plasma or serum separator according to claim 13, wherein the propanol with a butoxy group is butoxypropanol.

### Claim 15 (depends on 13)

The plasma or serum separator according to claim 13, wherein the acrylamide with a butoxy group is butoxymethylacrylamide.

### Claim 16 (depends on 13)

The plasma or serum separator according to claim 13, wherein the fibrous material and/or the porous material is one kind or two or more kinds selected from the group consisting of glass fibers, non-woven fabrics, cellulose fibers, polyester, polypropylene, polyamide, polyethylene, polyurethane and polyvinyl formal.

### Claim 17 (depends on 13)

The plasma or serum separator according to claim 13, wherein plasma or serum is isolated from whole blood by bringing the whole blood into contact with the blood separation member to hold red blood cells in the blood separation member and hemolysis is suppressed by using the blood separation member.

### Claim 18 (depends on 13)

A plasma or serum separating method of isolating plasma or serum from whole blood by bringing the whole blood into contact with the blood separation member to hold red blood cells in the blood separation member, wherein hemolysis is suppressed by using a plasma or serum separator according to claim 13.

### Claim 19 (depends on 13)

A test carrier comprising: a plasma or serum separation layer for isolating plasma or serum from a blood sample component and a test region for testing the isolated plasma or serum, wherein the plasma or serum separation layer comprises a plasma or serum separator according to claim 13 to thereby suppress hemolysis.

### Claim 20

A plasma or serum separator for isolating plasma or serum from whole blood, said separator comprising:
a blood separation member,
a holding member covering and holding the blood separation member;
a blood introducing portion formed in a portion of the holding member covering a proximal end portion of the blood separation member; and
a plasma or serum sampling aperture formed in a portion of the holding member covering a distal end portion of the blood separation member,
wherein the whole blood is introduced into the blood separation member through the blood introducing portion, and the introduced whole blood is separated such that the plasma or serum is located in the distal end portion of the blood separation member, while blood cells are located in the proximal end portion of the blood separation member; thereby enabling the plasma or serum located in the distal end portion of the blood separation member to be sampled through the plasma or serum sampling aperture,
wherein the blood separation member is made of a fibrous material, and
wherein the fibrous material is glass fibers and coated with hexylene glycol.

### Claim 21 (depends on 20)

A plasma or serum sampling method employing a plasma or serum separator according to claim 20, said method comprising the steps of:
sticking a needle-like tool in a blood sampling portion to cause the portion to bleed;
bringing the blood introducing portion of the plasma or serum separator into contact with the bleeding site to introduce whole blood into the blood separation member;
subjecting the introduced whole blood to separation by the blood separation member such that the plasma or serum is located in the distal end portion thereof, while blood cells are located in the proximal end portion thereof; and
sampling plasma or serum staying in the distal end portion of the blood separation member through the plasma or serum sampling aperture.

### Claim 22 (depends on 20)

The plasma or serum separator according to claim 20, wherein the holding member is a transparent or semi-transparent liquid non-penetrable film.

### Claim 23 (depends on 20)

The plasma or serum separator according to claim 20, wherein the blood introducing portion is covered with a network member capable of being penetrated by blood.

### Claim 24 (depends on 21)

The plasma or serum sampling method according to claim 21, wherein the holding member is a transparent or semi-transparent liquid non-penetrable film.

### Claim 25 (depends on 21)

The plasma or serum sampling method according to claim 21, wherein the blood introducing portion is covered with a network member capable of being penetrated by blood.

### Claim 26

A test carrier comprising:
a plasma or serum separation layer for isolating plasma or serum from a blood sample component and a test region for testing the isolated plasma or serum, wherein the plasma or serum separation layer comprises a plasma or serum separator,
wherein said separator includes a blood separation member having a fibrous material coated with hexylene glycol,
wherein the fibrous material is glass fibers, and
wherein said separator suppresses hemolysis.
