Packaged antimicrobial medical device having improved shelf life and method of preparing same

Patent metadata

Field	Value
Publication number	US-11707272-B2
Application number	US-201916272671-A
Country	US
Kind code	B2
Filing date	Feb 11, 2019
Priority date	Apr 6, 2012
Publication date	Jul 25, 2023
Grant date	Jul 25, 2023

Abstract

A packaged antimicrobial suture. The packaged antimicrobial suture includes an inner package having a source of antimicrobial agent, the source of antimicrobial agent comprising a plurality of patches, each patch having a pair of antimicrobial material reservoirs; at least one suture positioned within the inner package, the at least one suture comprising one or more surfaces; and an outer package having an inner surface, the outer package having the inner package positioned within; wherein the at least one suture, the inner package and the inner surface of the outer package are subjected to time, temperature and pressure conditions sufficient to transfer an effective amount of the antimicrobial agent from the antimicrobial agent source to the at least one suture and the inner package, thereby substantially inhibiting bacterial colonization on the at least one suture and the inner package. A method of making a packaged antimicrobial suture having is also provided.

First claim

What is claimed:

1. A method of making a packaged antimicrobial medical device, comprising:
providing a package having at least an inner surface and an outer surface;
positioning at least one medical device within the package;
providing a source of antimicrobial agent external to the package;
subjecting the medical device, at least the inner surface of the package and the antimicrobial agent source to time, temperature, and pressure conditions sufficient to transfer an effective amount of the antimicrobial agent from the antimicrobial agent source to the medical device and the inner surface of the package, thereby substantially inhibiting bacterial colonization on the medical device and the inner package surface; and
providing an adsorbent or absorbent material within the package,
wherein an inner package comprises a containment compartment that includes a plurality of patches, each patch having at least a pair of reservoirs formed of a porous medical grade paper or a permeable polymeric film or a fabric having a matrix structure, and an outer cover, the outer cover having one surface coated with the adsorbent or absorbent material.

2. The method of making a packaged antimicrobial medical device according to claim 1 , wherein the adsorbent or absorbent material is formed by coating a substrate with an adsorbent material.

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

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

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

6. The method of making a packaged antimicrobial medical device according to claim 1 , wherein the step of subjecting the medical device and the inner surface of the package to conditions sufficient to transfer an effective amount of the antimicrobial agent comprises the steps of:
placing the package and the medical device 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 package and the medical device 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 medical device; and
drying the packaged antimicrobial medical device to a desired moisture level.

7. The method of making a packaged antimicrobial medical device according to claim 6 , wherein the step of introducing a chemical sterilization agent comprises introducing ethylene oxide gas into the sterilization unit.

8. The method of making a packaged antimicrobial medical device according to claim 1 , wherein the medical device is selected from a suture, a surgical mesh, a hernia plug, a brachy seed spacer, a suture clip, a suture anchor, an adhesion prevention mesh or film or a suture knot clip.

9. The method of making a packaged antimicrobial medical device according to claim 1 , wherein the package including the medical device is placed in a sealed environment and the antimicrobial agent source is contained in the sealed environment.

10. The method of making a packaged antimicrobial medical device according to claim 1 , wherein the package including the medical device is placed in a sealed environment and the antimicrobial agent source is subsequently introduced into the sealed environment.

11. A method of making a packaged antimicrobial suture, the method comprising the steps of:
providing an inner package having a source of antimicrobial agent, the source of antimicrobial agent comprising a plurality of patches, each patch having at least a pair of antimicrobial agent reservoirs;
positioning at least one suture within the inner package, the at least one suture comprising one or more surfaces;
covering the inner package with an outer package having an inner surface; and
subjecting the at least one suture, the inner package, and the inner surface of the outer package to time, temperature, and pressure conditions sufficient to transfer an effective amount of the antimicrobial agent from the antimicrobial agent source to the at least one suture and the inner package, thereby substantially inhibiting bacterial colonization on the at least one suture and the inner package,
wherein said antimicrobial agent reservoirs are formed of a porous medical grade paper or a permeable polymeric film.

12. A method of making a packaged antimicrobial suture, the method comprising the steps of:
providing an antimicrobial agent from an external source to an inner package the inner package comprising a containment compartment having a base member and a channel cover member, the base member including an outer periphery, and an outer cover positioned upon channel cover member and within the outer periphery, to at least partially enclose at least one suture within the inner package, the at least one suture comprising one or more surfaces;
covering the inner package with an outer package having an inner surface; and
subjecting the at least one suture, the inner package, and the inner surface of the outer package to time, temperature, and pressure conditions sufficient to transfer an effective amount of the antimicrobial agent from the antimicrobial agent source to the at least one suture and the inner package, thereby substantially inhibiting bacterial colonization on the at least one suture and the inner package.

13. The method of making a packaged antimicrobial suture according to claim 12 , wherein the antimicrobial agent is selected from the group consisting of halogenated hydroxyl ethers, acyloxydiphenyl ethers, and combinations thereof.

14. The method of making a packaged antimicrobial suture according to claim 12 , wherein the antimicrobial agent is selected from the group consisting of halogenated hydroxyl ethers, acyloxydiphenyl ethers, and combinations thereof.

Assignees

• Ethicon Llc
• Cilag Gmbh Int

Inventors

• Prikril Michael David
• Scalzo Jr Howard L
• Gisin Leon

Classifications

• A61B17/06133 Primary

  of parallelepipedal shape, e.g. made of rectangular or slightly oval panels · CPC title

• A61L17/005

  containing a biologically active substance, e.g. a medicament or a biocide · CPC title

• B65B55/18

  by liquids or gases (B65B55/14 takes precedence) · CPC title

• A61B17/06166

  Sutures (suture materials A61L17/00; manufacture of artificial threads D01D; treatment of threads D06M) · CPC title

• A61B2017/00526

  Methods of manufacturing · CPC title