Preventing biofilm formation on implantable medical devices

• US 8,315,700 B2
• Filed: 12/28/2009
• Issued: 11/20/2012
• Est. Priority Date: 02/08/2006
• Status: Active Grant

• Current Assignee: Medtronic Incorporated (Medtronic Plc)
• Original Assignee: TYRX, INC. (Medtronic Plc)
• Inventors: McJames, William, Citron, Mark
• Primary Examiner(s): Wax, Robert A
• Assistant Examiner(s): CRAIGO, WILLIAM A
• Application Number:
  US12/648,126
• Publication Number:
  US 20100168808A1
• Time in Patent Office: 1,058 Days
• Field of Search: None
• US Class Current: 607/5
• CPC Class Codes: A61B 2017/00889 antimicrobial, disinfectant
• CPC Class Codes: A61B 2017/00893 pharmaceutically effective
• CPC Class Codes: A61B 2090/0815 Implantable devices for insertion in between organs or other soft tissues
• CPC Class Codes: A61L 2300/404 Biocides, antimicrobial agents, antiseptic agents
• CPC Class Codes: A61L 31/10 Macromolecular materials
• CPC Class Codes: A61L 31/146 Porous materials, e.g. foams or sponges
• CPC Class Codes: A61L 31/148 Materials at least partially resorbable by the body
• CPC Class Codes: A61L 31/16 Biologically active materials, e.g. therapeutic substances A61L31/047 takes precedence
• CPC Class Codes: A61N 1/375 Constructional arrangements, e.g. casings
• CPC Class Codes: A61N 1/37512 Pacemakers
• CPC Class Codes: C08L 67/03 the dicarboxylic acids and dihydroxy compounds having the carboxyl- and the hydroxy groups directly linked to aromatic rings

Abstract

Biodegradable polymer-coated surgical meshes formed into pouches are described for use with cardiac rhythm management devices (CRMs) and other implantable medical devices. Such meshes are formed into a receptacle, e.g., a pouch or other covering, capable of encasing, surrounding and/or holding the cardiac rhythm management device or other implantable medical device and preventing or retarding the formation of a biofilm.

Claims

1. A method of retarding biofilm formation on an implantable medical device which comprises:

(a) enveloping or covering said device, in whole or in part, in a polymer pouch comprising a polymer-coated mesh pouch comprising one or more resorbable polymers comprising tyrosine-based polyarylates coated on the mesh and including one or more antimicrobial agents in amounts effective to retard biofilm formation; and

(b) implanting said enveloped device in a subject.

2. The method of claim 1, wherein the polymer-coated mesh pouch comprises one or more resorbable polymers coated on the mesh.

3. The method of claim 1, wherein the one or more antimicrobial agents inhibit biofilm formation by one or more of Staphylococcus aureus, Staphylococcus epidermidis, Escherichia coli or Acinetobacter baummanii.

4. The method of claim 2, wherein the one or more antimicrobial agents inhibit biofilm formation by one or more of Staphylococcus aureus, Staphylococcus epidermidis, Escherichia coli or Acinetobacter baummanii.

5. The method of claim 1, wherein said implantable medical device is a cardiac rhythm management device (CRMD), a neurostimulator, a pulse generator, a drug pump or infusion device, a physiological monitoring device, or a textured or smooth breast implant.

6. The method of claim 5, wherein the implantable medical device is a CRMD selected from the group consisting of a pacemaker, a defibrillator, an implantable cardioverter defibrillator (ICD), and a cardiac resynchronization therapy defibrillator (CRT device).

7. The method of claim 1, wherein said coating comprises two or more layers, and at least one layer of the coating comprises at least one antimicrobial agent and at least one biocompatible polymer.

8. The method of claim 1, wherein the at least one antimicrobial agent comprises rifampin and minocycline.

9. The method of claim 2, wherein the at least one antimicrobial agent comprises rifampin and minocycline.

10. The method of claim 9, wherein the amounts of rifampin and minocycline in the coating ranges from about 60-90 μ

g/cm² for each of rifampin and minocycline.

11. The method of claim 10, wherein the coating comprises about 0.5-1.0 mg resorbable polymer/cm².

12. The method of claim 9, wherein the tyrosine-based polyarylates comprise a DTE-27.5% DT succinate polyarylate.

13. The method of claim 11, wherein the resorbable polymer is DTE-27.5% DT succinate polyarylate.