Method of making a packaged antimicrobial suture

• US 8,112,973 B2
• Filed: 06/29/2009
• Issued: 02/14/2012
• Est. Priority Date: 10/04/2002
• Status: Active Grant

• Current Assignee: Ethicon Incorporated (Johnson & Johnson)
• Original Assignee: Ethicon Incorporated (Johnson & Johnson)
• Inventors: Scalzo, Howard, Pokropinski, Henry Jr., Fischer, Jerry
• Primary Examiner(s): DESAI, HEMANT
• Application Number:
  US12/493,992
• Publication Number:
  US 20100163435A1
• Time in Patent Office: 960 Days
• Field of Search: 534/25, 534/28, 531/11.R, 535/10
• US Class Current: 53/428
• CPC Class Codes: A61B 17/06114 Packages or dispensers for needles or sutures packages for sharps A61B50/3001; for dental floss A61C15/043; packages for needles in general B65D85/24
• CPC Class Codes: A61B 17/06138 including a retainer comprising three or more foldable panels
• CPC Class Codes: A61B 17/06166 Sutures suture materials A61L17/00; manufacture of artificial threads D01D; treatment of threads D06M
• CPC Class Codes: A61B 2017/00526 Methods of manufacturing
• CPC Class Codes: A61B 2017/00889 antimicrobial, disinfectant
• CPC Class Codes: A61B 2017/06142 having needle- or suture- retaining members, e.g. holding tabs or needle parks
• CPC Class Codes: A61B 2050/314 Flexible bags or pouches
• CPC Class Codes: A61L 17/005 containing a biologically active substance, e.g. a medicament or a biocide
• CPC Class Codes: A61L 2300/404 Biocides, antimicrobial agents, antiseptic agents

Abstract

A method of making a packaged antimicrobial suture having improved shelf life. The method comprising the steps of providing an inner package having a source of antimicrobial agent, providing an adsorbent material effective to adsorb a portion of the antimicrobial agent over time, positioning a suture within the inner package, the suture comprising one or more surfaces, covering the inner package with an outer package having an inner surface and subjecting the suture, the inner package and the inner surface of the outer package to time, temperature and pressure conditions sufficient to vapor transfer an effective amount of the antimicrobial agent from the antimicrobial agent source to the suture and the inner package, thereby substantially inhibiting bacterial colonization on the suture and the inner package, wherein the packaged antimicrobial suture exhibits improved shelf life. A packaged antimicrobial suture and a method of increasing the shelf life of a packaged antimicrobial medical device are also provided.

Claims

1. A method of making a packaged antimicrobial suture having improved shelf life, the method comprising the steps of:

providing an inner package having a source of antimicrobial agent;

providing an adsorbent material effective to adsorb a portion of the antimicrobial agent over time;

positioning a suture within the inner package, the suture comprising one or more surfaces;

covering the inner package with an outer package having an inner surface; and

subjecting the suture, the inner package and the inner surface of the outer package to time, temperature and pressure conditions sufficient to vapor transfer an effective amount of the antimicrobial agent from the antimicrobial agent source to the suture and the inner package, thereby substantially inhibiting bacterial colonization on the suture and the inner package, wherein the packaged antimicrobial suture exhibits improved shelf life.

2. The method of making a packaged antimicrobial suture according to claim 1, wherein the adsorbent material is provided by coating the adsorbent material on at least a portion of one surface of the inner package.

3. The method of making a packaged antimicrobial suture according to claim 1, wherein the adsorbent material is provided by placing an adsorbent substrate within the outer package.

4. The method of making a packaged antimicrobial suture according to claim 3, wherein the adsorbent substrate is formed by coating a substrate with an adsorbent material.

5. The method of making a packaged antimicrobial suture according to claim 3, wherein the adsorbent substrate is formed of an adsorbent material.

6. The method of making a packaged antimicrobial suture according to claim 1, wherein the suture positioned within the inner package is substantially free of antimicrobial agent.

7. The method of making a packaged antimicrobial suture according to claim 1, wherein the suture positioned within the inner package is coated with antimicrobial agent.

8. The method of making a packaged antimicrobial suture according to claim 1, wherein the antimicrobial agent is selected from the group consisting of halogenated hydroxyl ethers, acyloxydiphenyl ethers, and combinations thereof.

9. The method of making a packaged antimicrobial suture according to claim 1, wherein the effective amount of the antimicrobial agent transferred from the source of antimicrobial agent to the suture and the inner package is transferred during an ethylene oxide sterilization process.

10. The method of making a packaged antimicrobial suture according to claim 1, wherein the step of subjecting the suture, the inner package and the inner surface of the outer package to conditions sufficient to vapor transfer an effective amount of the antimicrobial agent comprises the steps of:

placing the outer package having the inner package and the suture therein in a sterilization unit;

heating the sterilization unit to a first temperature;

adjusting the pressure in the sterilization unit to a first pressure value;

injecting steam into the sterilization unit to expose the inner surface of the outer package, the inner package and the suture to water vapor for a first period of time;

adjusting the pressure within the sterilization unit to a second pressure value;

introducing a chemical sterilization agent into the sterilization unit;

maintaining the chemical sterilization agent in the sterilization unit for a second period of time to render a sufficient amount of microorganisms non-viable;

removing residual moisture and chemical sterilization agent from the suture; and

drying the packaged antimicrobial suture to a desired moisture level.

11. The method of making a packaged antimicrobial suture according to claim 10, wherein the step of introducing a chemical sterilization agent comprises introducing ethylene oxide gas into the sterilization unit.

12. The method of making a packaged antimicrobial suture according to claim 1, wherein the inner package comprises a universal envelope formed from a paperboard stock having at least one surface coated with an adsorbent material.

13. The method of making a packaged antimicrobial suture according to claim 12, wherein the adsorbent material is selected from bentonite, activated carbon, activated alumina, silica gel, zeolite, super-absorbant polymers, humectants, polymeric coatings, ground polymeric coatings, natural products, non-paper substrates, and clays, including kaolin.

14. The method of making a packaged antimicrobial suture according to claim 1, wherein the inner package comprises a containment compartment and an outer cover, the outer cover having an one surface coated with an adsorbent material.

15. The method of making a packaged antimicrobial suture according to claim 14, wherein the adsorbent material is selected from bentonite, activated carbon, activated alumina, silica gel, zeolite, super-absorbant polymers, humectants, polymeric coatings, ground polymeric coatings, natural products, non-paper substrates, and clays, including kaolin.

16. A method of increasing the shelf life of a packaged antimicrobial medical device, the method comprising the steps of:

providing an inner package having a source of antimicrobial agent;

providing an adsorbent material effective to adsorb a portion of the antimicrobial agent over time;

positioning a medical device within the inner package, the medical device comprising one or more surfaces;

covering the inner package with an outer package having an inner surface; and

subjecting the medical device, the inner package and the inner surface of the outer package to time, temperature and pressure conditions sufficient to vapor transfer an effective amount of the antimicrobial agent from the antimicrobial agent source to the medical device and the inner package, thereby substantially inhibiting bacterial colonization on the medical device and the inner package,

wherein the packaged antimicrobial medical device exhibits improved shelf life.

17. The method of increasing the shelf life of a packaged antimicrobial medical device according to claim 16, wherein the adsorbent material is provided by coating the adsorbent material on at least a portion of an one surface of the inner package.

18. The method of increasing the shelf life of a packaged antimicrobial medical device according to claim 16, wherein the adsorbent material is provided by placing an adsorbent substrate within the outer package.

19. The method of increasing the shelf life of a packaged antimicrobial medical device according to claim 18, wherein the adsorbent substrate is formed by coating a substrate with an adsorbent material.

20. The method of increasing the shelf life of a packaged antimicrobial medical device according to claim 18, wherein the adsorbent substrate is formed of an adsorbent material.

21. The method of increasing the shelf life of a packaged antimicrobial medical device according to claim 16, wherein the inner package comprises a universal envelope formed from a paperboard stock having at least one surface coated with an adsorbent material.

22. The method of increasing the shelf life of a packaged antimicrobial medical device according to claim 21, wherein the adsorbent material is selected from bentonite, activated carbon, activated alumina, silica gel, zeolite, super-absorbant polymers, humectants, polymeric coatings, ground polymeric coatings, natural products, non-paper substrates, and clays, including kaolin.

23. The method of increasing the shelf life of a packaged antimicrobial medical device according to claim 16, wherein the inner package comprises a containment compartment and an outer cover, the outer cover having an one surface coated with an adsorbent material.

24. The method of increasing the shelf life of a packaged antimicrobial medical device according to claim 23, wherein the adsorbent material is selected from bentonite, activated carbon, activated alumina, silica gel, zeolite, super-absorbant polymers, humectants, polymeric coatings, ground polymeric coatings, natural products, non-paper substrates, and clays, including kaolin.