Method of preparing a packaged antimicrobial medical device

• US 8,156,718 B2
• Filed: 04/02/2009
• Issued: 04/17/2012
• Est. Priority Date: 10/04/2002
• Status: Active Grant

• Current Assignee: Ethicon Incorporated (Johnson & Johnson)
• Original Assignee: Ethicon Incorporated (Johnson & Johnson)
• Inventors: Scalzo, Howard, Fischer, Jerome A., Rothenburger, Stephen, Cerwin, Robert, McDivitt, James R.
• Primary Examiner(s): HARMON, CHRISTOPHER R
• Application Number:
  US12/417,518
• Publication Number:
  US 20090301033A1
• Time in Patent Office: 1,111 Days
• Field of Search: 534/25, 534/26, 534/49, 531/67, 606/228, 606/229, 606/230, 606/232, 604/172, 206/63.3
• US Class Current: 53/425
• 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 17/06166 Sutures suture materials A61L17/00; manufacture of artificial threads D01D; treatment of threads D06M
• CPC Class Codes: A61B 2017/00889 antimicrobial, disinfectant
• CPC Class Codes: A61B 50/00 Containers, covers, furniture or holders specially adapted for surgical or diagnostic appliances or instruments, e.g. sterile covers drapes specially adapted for instruments A61B46/10
• CPC Class Codes: A61L 17/005 containing a biologically active substance, e.g. a medicament or a biocide
• CPC Class Codes: A61L 2300/202 with halogen atoms, e.g. triclosan, povidone-iodine
• CPC Class Codes: A61L 2300/404 Biocides, antimicrobial agents, antiseptic agents
• CPC Class Codes: A61L 2300/606 Coatings

Abstract

A method of making a packaged antimicrobial suture comprising the steps of providing a containment compartment that is substantially free of an antimicrobial agent; positioning a suture within the containment compartment, said suture comprising one or more surfaces having an antimicrobial agent disposed thereon, said antimicrobial agent being selected from the group consisting of halogenated hydroxyl ethers, acyloxydiphenyl ethers, and combinations thereof; placing the containment compartment having the suture in an outer package; and subjecting the outer package, the containment compartment and the suture to time, temperature and pressure conditions sufficient to vapor transfer an effective amount of the antimicrobial agent from the suture to the containment compartment, while retaining an effective amount of said antimicrobial agent on the suture, thereby substantially inhibiting bacterial colonization on the suture and the containment compartment.

Claims

1. A method of making a packaged antimicrobial suture comprising the steps of:

providing a containment compartment that is substantially free of an antimicrobial agent;

positioning a suture within the containment compartment, said suture comprising one or more surfaces having an antimicrobial agent disposed thereon, said antimicrobial agent being selected from the group consisting of halogenated hydroxyl ethers, acyloxydiphenyl ethers, and combinations thereof;

placing the containment compartment having the suture in an outer package; and

subjecting the outer package, the containment compartment and the suture to time, temperature and pressure conditions sufficient to vapor transfer an effective amount of the antimicrobial agent from the suture to an inner surface of the containment compartment, while retaining an effective amount of said antimicrobial agent on the suture, thereby substantially inhibiting bacterial colonization on the suture and the containment compartment,

wherein said step of subjecting the outer package, the containment compartment and the suture to conditions sufficient to vapor transfer an effective amount of the antimicrobial agent from the suture to an inner surface of the containment compartment, while retaining an effective amount of said antimicrobial agent on the suture includes adjusting the pressure to not more than 0.005 kPa at a temperature greater than room temperature.

2. The method for making a packaged antimicrobial suture according to claim 1, wherein said step of subjecting the outer package, the containment compartment and the suture to conditions sufficient to vapor transfer an effective amount of the antimicrobial agent from the suture to an inner surface of the containment compartment, while retaining an effective amount of said antimicrobial agent on the suture includes an ethylene oxide sterilization process.

3. The method for making a packaged antimicrobial suture according to claim 1, wherein the step of subjecting the outer package, the containment compartment and the suture to conditions sufficient to vapor transfer an effective amount of the antimicrobial agent from the suture to an inner surface of the containment compartment, while retaining an effective amount of said antimicrobial agent on the suture further comprises the steps of:

placing the outer package having the containment compartment 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 outer package, the containment compartment 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 within the package nonviable;

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

drying the packaged antimicrobial suture to a desired moisture level.

4. The method for making a packaged antimicrobial suture according to claim 3, wherein the step of introducing a chemical sterilization agent comprises introducing ethylene oxide gas into the sterilization unit.

6. The method of claim 1, wherein the suture comprising one or more surfaces having an antimicrobial agent disposed thereon further comprises at least one active agent selected from the group consisting of a biocide, a disinfectant, an antiseptic, an antibiotic, an antimicrobial peptide, a lytic bacteriophage, a surfactant;

an adhesion blocker;

an oligonucleotide, an efflux pump inhibitors;

a photosensitive dye, an immune modulator and a chelator.

5. A method of making a packaged medical device comprising the steps of:

providing a package comprising an inner surface that is substantially free of an antimicrobial agent;

positioning a medical device within the package, said medical device comprising one or more surfaces having an antimicrobial agent disposed thereon, said antimicrobial agent being selected from the group consisting of halogenated hydroxyl ethers, acyloxydiphenyl ethers, and combinations thereof; and

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

wherein said step of subjecting the outer package, the containment compartment and the suture to conditions sufficient to vapor transfer an effective amount of the antimicrobial agent from the suture to an inner surface of the containment compartment, while retaining an effective amount of said antimicrobial agent on the suture includes adjusting the pressure to not more than 0.005 kPa at a temperature greater than room temperature.

7. The method of claim 5, wherein the medical device comprising one or more surfaces having an antimicrobial agent disposed thereon further comprises at least one active agent selected from the group consisting of a biocide, a disinfectant, an antiseptic, an antibiotic, an antimicrobial peptide, a lytic bacteriophage, a surfactant;

an adhesion blocker;

an oligonucleotide, an efflux pump inhibitors;

a photosensitive dye, an immune modulator and a chelator.

8. The method according to claim 5, wherein said step of subjecting the outer package, the containment compartment and the suture to conditions sufficient to vapor transfer an effective amount of the antimicrobial agent from the suture to an inner surface of the containment compartment, while retaining an effective amount of said antimicrobial agent on the suture includes an ethylene oxide sterilization process.

9. The method according to claim 8, wherein the package is subjected to a pressure of less than about 1.0 kPa.