# US 11,305,041 B2 · Oxygenator antithrombotic coating and method of manufacture

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- Number: US 11,305,041 B2
- Document ID: US11305041B2
- Status: Granted
- Kind: B2
- Application number: 16/920,877
- Filed: 2020-07-06
- Published: 2020-10-22
- Granted: 2022-04-19
- Earliest claimed: 2018-01-10
- Assignees: Terumo Kabushiki Kaisha
- Applicants: Terumo Kabushiki Kaisha
- Inventors: Takayuki Kido; Takao Anzai
- Web page: https://patentgrep.com/patent/US11305041B2

## CPC

- A61M 1/1625: {Dialyser of the outside perfusion type, i.e. blood flow outside hollow membrane fibres or tubes}
- A61M 1/1645: {with mechanically linked peristaltic dialysis fluid pumps one upstream, the other one downstream of the dialyser}
- A61M 1/1698: {Blood oxygenators with or without heat-exchangers (intracorporal A61M1/1678; manufacturing of membranes therefor B01D67/00; semi-permeable membranes for separation processes characterised by their properties B01D69/00; semi-permeable membranes characterised by their material B01D71/00)}
- A61M 1/3673: {Anticoagulant coating, e.g. Heparin coating}
- B01D 63/031: {Two or more types of hollow fibres within one bundle or within one potting or tube-sheet}
- B01D 63/04: comprising multiple hollow fibre assemblies
- B01D 67/0088: {Physical treatment with compounds, e.g. swelling, coating or impregnation}
- B01D 69/02: characterised by their properties
- A61M 2202/0225: Carbon oxides, e.g. Carbon dioxide
- A61M 2207/10: Device therefor
- B01D 2313/68: Biocompatibility of parts of the module
- 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)}
- B01D: SEPARATION (separating solids from solids by wet methods B03B, B03D; by pneumatic jigs or tables B03B; by other dry methods B07; magnetic or electrostatic separation of solid materials from solid materials or fluids, separation by high-voltage electric fields B03C; centrifuges, vortex apparatus B04; presses per se for squeezing-out liquid from liquid-containing material B30B9/02; treatment of water C02F, e.g. softening by ion-exchange C02F1/42; {arrangements of air intake cleaners in gas turbine plants F02C7/05} ; arrangements or mounting of filters in air-conditioning, air-humidification or ventilation F24F13/28)

## Abstract

Hollow fiber membranes in an oxygenator for an extracorporeal blood circulator are coated with an antithrombotic polymeric material. The porous hollow fiber membranes for gas exchange have outer surfaces, inner surfaces forming lumens, opening portions through which the outer surfaces communicate with the inner surfaces in a housing. A blood flow path is outside of the hollow fiber membrane bundle in the housing, between a blood inlet port and a blood outlet port. The coating is obtained by filling the blood flow path with a colloidal solution containing an antithrombotic polymeric compound, and moving the colloid solution between the blood inlet port and the blood outlet port for a time that coats a predetermined amount of antithrombotic polymeric compound on the outer surfaces of the hollow fiber membranes. Other surfaces within the oxygenator contacting the blood flow likewise receive the coating.

## Claims

### Claim 1

A method for manufacturing an oxygenator having a housing retaining a hollow fiber membrane bundle, wherein the hollow fiber membrane bundle comprises a plurality of porous hollow fiber membranes for gas exchange which have outer surfaces, inner surfaces forming lumens, and opening portions through which the outer surfaces communicate with the inner surfaces, wherein the oxygenator defines a blood flow path which is outside of the hollow fiber membranes in the housing between a blood inlet port and a blood outlet port, the method comprising:
filling the blood flow path with a colloidal solution containing an antithrombotic polymeric compound; and
moving the colloidal solution along the blood flow path between the blood inlet port and the blood outlet port for a time that coats a predetermined amount of antithrombotic polymeric compound on the outer surfaces of the hollow fiber membranes;
wherein the lumens of the hollow fiber membranes are used as a gas flow path, and carbon dioxide gas is passed through the gas flow path while moving the colloidal solution between the blood inlet port and the blood outlet port.

### Claim 2 (depends on 1)

The method for manufacturing an oxygenator according to claim 1, wherein the colloidal solution is moved alternately back and forth between the blood inlet port and the blood outlet port.

### Claim 3 (depends on 1)

The method for manufacturing an oxygenator according to claim 1, wherein the colloidal solution is circulated by a pump coupled to the blood inlet port and the blood outlet port.

### Claim 4 (depends on 1)

The method for manufacturing an oxygenator according to claim 1, wherein a flow rate of the carbon dioxide gas is 0.5 L/min·m2 or more and 20 L/min·m2 or less with respect to a membrane area (m2) of a hollow fiber membrane.

### Claim 5 (depends on 1)

The method for manufacturing an oxygenator according to claim 1, wherein the colloidal solution contains 0.01% by mass or more of an antithrombotic polymeric compound.

### Claim 6 (depends on 1)

The method for manufacturing an oxygenator according to claim 1, wherein the antithrombotic polymeric compound has a structural unit derived from alkoxyalkyl(meth)acrylate represented by the following Formula (I):
wherein R3 represents a hydrogen atom or a methyl group, R1 represents an alkylene group having 1 to 4 carbon atoms, and R2 represents an alkyl group having 1 to 4 carbon atoms.

### Claim 7 (depends on 1)

The method for manufacturing an oxygenator according to claim 1, wherein a weight average molecular weight of the antithrombotic polymeric compound is more than 200,000 and less than 800,000.