METHOD FOR RADIATION STERILIZATION OF HYDROPHILIC POLYMER-COATED MEDICAL DEVICE

• US 20110058982A1
• Filed: 04/30/2009
• Published: 03/10/2011
• Est. Priority Date: 05/16/2008
• Status: Active Grant

• Current Assignee: Terumo Kabushiki Kaisha
• Original Assignee: Terumo Kabushiki Kaisha
• Inventors: Kaneko, Takashi
• Granted Patent: US 8,968,648 B2
• Time in Patent Office: Days
• US Class Current: 422/22
• CPC Class Codes: A61L 2/08 Radiation
• CPC Class Codes: A61L 2/087 Particle radiation, e.g. electron-beam, alpha or beta radiation
• CPC Class Codes: A61L 2202/24 Medical instruments, e.g. endoscopes, catheters, sharps
• CPC Class Codes: A61M 2025/0046 Coatings for improving slidability
• CPC Class Codes: A61M 25/0017 specially adapted for long-term hygiene care, e.g. urethral or indwelling catheters to prevent infections
• CPC Class Codes: A61M 25/002 Packages specially adapted therefor combined with means for introducing catheters, e.g. dispensers, A61M25/0113; catheter kit packages for surgical articles A61B50/30
• CPC Class Codes: A61M 25/0045 multi-layered, e.g. coated coating materials A61L29/08
• CPC Class Codes: A61M 25/09 Guide wires

Abstract

A radiation sterilization method of a disposable medical device and a manufacturing method are provided, which method comprising the steps of packaging a disposable medical device, which has applied thereto with hydrophilic polymer coating, with a gas permeable packaging material, controlling a product moisture content of the thus packaged medical device by maintaining the device in a given humidity atmosphere for not less than a time at which an equilibrated moisture content is reached, and subjecting, to radiation sterilization, the medical device whose product moisture content has been controlled, so that an eluted matter is reduced in amount and a sliding performance is ensured according to the radiation sterilization method of the hydrophilic polymer-coated, disposable medical device and the manufacturing method.

Claims

1. A radiation sterilization method of medical devices, which comprising packaging a disposable medical device having a hydrophilic polymer coating with a gas-permeable packaging material, controlling a product moisture content, and subjecting to radiation sterilization.

2. The radiation sterilization method as defined in claim 1, wherein said disposable medical device is a catheter or a guide wire.

3. The radiation sterilization method as defined in claim 1, wherein the product moisture content is so controlled that said disposable medical device packaged with the gas-permeable packaging material is maintained in a predetermined humidity atmosphere for more than a time at which the moisture content reaches an equilibrium.

4. The radiation sterilization method as defined in claim 1, wherein the product moisture content is so controlled that said disposable medical device packaged with the gas-permeable packaging material is maintained in a humidity environment of a relative humidity of 60 to 98% RH for three hours or over.

5. The radiation sterilization method as recited in claim 1, wherein the gas-permeable packaging material is a moisture permeable pouch having a moisture permeability of 1000 g/m²-24 hours (25°

C., 90% RH) or over and incapable of transmitting water at a normal pressure.

6. The radiation sterilization method as defined in claim 1, wherein the hydrophilic polymer is made of a monoalkyl ester of methyl vinyl ether/maleic anhydride copolymer or a copolymer made primarily of the monoalkyl ester of the copolymer and a moisture content of the medical device at the time of the radiation irradiation ranges 0.1 to 0.5 mass %.

7. The radiation sterilization method as defined in claim 1, wherein the hydrophilic polymer is made of polyvinylpyrrolidone or a copolymer made primarily of polyvinylpyrrolidone and a moisture content of the medical device at the time of radiation irradiation ranges 0.1 to 0.5 mass %.

12. The radiation sterilization method as defined in claim 2, wherein the product moisture content is so controlled that said disposable medical device packaged with the gas-permeable packaging material is maintained in a predetermined humidity atmosphere for more than a time at which the moisture content reaches an equilibrium.

13. The radiation sterilization method as defined in claim 2, wherein the product moisture content is so controlled that said disposable medical device packaged with the gas-permeable packaging material is maintained in a humidity environment of a relative humidity of 60 to 98% RH for three hours or over.

14. The radiation sterilization method as recited in claim 2, wherein the gas-permeable packaging material is a moisture permeable pouch having a moisture permeability of 1000 g/m²-24 hours (25°

C., 90% RH) or over and incapable of transmitting water at a normal pressure.

15. The radiation sterilization method as defined in claim 2, wherein the hydrophilic polymer is made of a monoalkyl ester of methyl vinyl ether/maleic anhydride copolymer or a copolymer made primarily of the monoalkyl ester of the copolymer and a moisture content of the medical device at the time of the radiation irradiation ranges 0.1 to 0.5 mass %.

16. The radiation sterilization method as defined in claim 2, wherein the hydrophilic polymer is made of polyvinylpyrrolidone or a copolymer made primarily of polyvinylpyrrolidone and a moisture content of the medical device at the time of radiation irradiation ranges 0.1 to 0.5 mass %.

8. A method for manufacturing a medical device, which comprising providing a disposable medical device having a hydrophilic polymer coating, packaging said medical device with a gas-permeable packaging material, controlling a product moisture content, and subjecting to radiation sterilization.

9. The manufacturing method as defined in claim 8, wherein said product moisture content is controlled by keeping the disposable medical device packaged with the gas-permeable packaging material in a predetermined humidity atmosphere for more than a time at which the moisture content reaches an equilibrium.

10. The manufacturing method as defined in claim 8, wherein said product moisture content is controlled by keeping the disposable medical device packaged with the gas-permeable packaging material in a humidity environment of a relative humidity of 60 to 98% RH for three hours or over.

11. The manufacturing method as defined in claim 8, wherein said gas-permeable packaging material is a moisture permeable pouch having a moisture permeability of 1000 g/m²-24 hours (25°

C., 90% RH) or over and incapable of transmitting water at a normal pressure.

17. The manufacturing method as defined in claim 9, wherein said product moisture content is controlled by keeping the disposable medical device packaged with the gas-permeable packaging material in a humidity environment of a relative humidity of 60 to 98% RH for three hours or over.

18. The manufacturing method as defined in claim 9, wherein said gas-permeable packaging material is a moisture permeable pouch having a moisture permeability of 1000 g/m²-24 hours (25°

C., 90% RH) or over and incapable of transmitting water at a normal pressure.