Mesh Pouches for Implantable Medical Devices

• US 20080132922A1
• Filed: 11/06/2007
• Published: 06/05/2008
• Est. Priority Date: 02/08/2006
• Status: Active Grant

• Current Assignee: Medtronic Incorporated (Medtronic Plc)
• Original Assignee: TYRX Pharma, Inc. (Medtronic Plc)
• Inventors: Timothy, Shari, Pulapura, Satish, Buevich, Fatima, Moses, Arikha, Edelman, William, Diamond, Mason, Do, Frank, McJames, William
• Granted Patent: US 8,591,531 B2
• Time in Patent Office: Days
• US Class Current: 606/151
• 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 2300/00 Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices
• 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

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 for the purpose of securing it in position, inhibiting or reducing bacterial growth, providing pain relief and/or inhibiting scarring or fibrosis on or around the CRM or other implantable medical device. Preferred embodiments include surgical mesh pouches coated with one or more biodegradable polymers that can act as a stiffening agent by coating the filaments or fibers of the mesh to temporarily immobilize the contact points of those filaments or fibers and/or by increasing the stiffness of the mesh by at least 1.1 times its original stiffness. The pouches of the invention can also provide relief from various post-operative complications associated with their implantation, insertion or surgical use, and, optionally, include one or more drugs in the polymer matrix of the coating to provide prophylactic effects and/or alleviate side effects or complications associated with the surgery or implantation of the CRM or other implantable medical device.

Claims

1. A mesh pouch comprising a surgical mesh with one or more biodegradable and resorbable polymer coatings, said pouch being a prophylactic encasement for a medical device unit.

2. The mesh pouch of claim 1, wherein said mesh has one or more coatings which temporarily stiffen the mesh to at least 1.1 times its original stiffness;

said mesh being formed to encapsulate an implantable device; and

said one or more coatings comprising one or more biodegradable polymers and one or more drugs which, alone or in combination, are capable of providing pain relief, inhibiting scarring or fibrosis and/or inhibiting bacterial growth.

3. The mesh pouch of claim 1, wherein said mesh has one or more coatings, wherein said one or more coatings comprise one or more biodegradable polymers which act as a stiffening agent and coat filaments or fibers of said mesh to temporarily immobilize contact points of the filaments or fibers of said mesh;

said mesh is formed to encapsulate an implantable device; and

said one or more coatings further comprise one or more drugs which, alone or in combination, are capable of providing pain relief, inhibiting scarring or fibrosis and/or inhibiting bacterial growth.

4. The mesh pouch of claim 3, wherein said mesh remains porous when coated with said agent.

5. The mesh pouch of claim 3, wherein said agent selectively and/or partially coats said filaments or said fibers.

6. The mesh pouch of claim 3, wherein said contact points comprise the knots in a woven mesh.

7. The mesh pouch of claim 2 or 3, wherein said one or more coatings increases stiffness of said mesh by at least 1.1 to about 4.5 times its uncoated stiffness.

8. The mesh pouch of any one of claims 1, 2 or 3, wherein said mesh comprises woven polypropylene.

9. The mesh pouch of any one of claims 1, 2 or 3, wherein said one or more biodegradable polymers are selected from the group consisting of a polylactic acid, polyglycolic acid, poly(L-lactide), poly(D,L-lactide), polyglycolic acid, poly(L-lactide-co-D,L-lactide), poly(L-lactide-co-glycolide), poly(D, L-lactide-co-glycolide), poly(glycolide-co-trimethylene carbonate), poly(D,L-lactide-co-caprolactone), poly(glycolide-co-caprolactone), polyethylene oxide, polyoxaester, polydioxanone, polypropylene fumarate, poly(ethyl glutamate-co-glutamic acid), poly(tert-butyloxy-carbonylmethyl glutamate), polycaprolactone, polycaprolactone co-butylacrylate, polyhydroxybutyrate, poly(phosphazene), poly(phosphate ester), poly(amino acid), polydepsipeptide, maleic anhydride copolymer, polyiminocarbonates, poly[(97.5% dimethyl-trimethylene carbonate)-co-(2.5% trimethylene carbonate)], poly(orthoesters), tyrosine-derived polyarylate, tyrosine-derived polycarbonate, tyrosine-derived polyiminocarbonate, tyrosine-derived polyphosphonate, polyalkylene oxide, hydroxypropylmethylcellulose, polysaccharide, protein, and copolymers, terpolymers and blends of any thereof.

10. The mesh pouch of any one of claims 1, 2 or 3, wherein at least one of said biodegradable polymers comprise one or more tyrosine-derived diphenol monomer units.

11. The mesh pouch of claim 10, wherein said polymer is a polyarylate.

12. The mesh pouch of claim 11, wherein said polyarylate is DT-DTE succinate having from about 1% DT to about 30% DT.

13. The mesh pouch of claim 11, wherein said polyarylate is a random copolymer of desaminotyrosyl-tyrosine (DT) and an desaminotyrosyl-tyrosyl ester (DT ester), wherein said copolymer comprises from about 0.001% DT to about 80% DT and said ester moiety can be a branched or unbranched alkyl, alkylaryl, or alkylene ether group having up to 18 carbon atoms, any of group of which can, optionally have a polyalkylene oxide therein.

14. The mesh pouch of any one of claims 1, 2 or 3, wherein said coating comprises one or more drugs are selected from the group consisting of antimicrobial agents, anesthetics, analgesics, anti-inflammatory agents, anti-scarring agents, anti-fibrotic agents and leukotriene inhibitors.

15. The mesh pouch of claim 14, wherein said drug is an anesthetic.

16. The mesh pouch of claim 15, wherein said anesthetic is bupivacaine HCl.

17. The mesh pouch of claim 14, wherein said drug is an antimicrobial agent.

18. The mesh pouch of claim 17, wherein said antimicrobial agent is selected from the group consisting of rifampin, minocycline, silver/chlorhexidine, vancomycin, a cephalosporin, gentamycin, triclosan and combinations thereof.

19. The mesh pouch of claim 17, comprising two antimicrobial agents, said agents being rifampin in combination with gentamycin or vancomycin.

20. The mesh pouch of claim 17, comprising two antimicrobial agents, said agents being rifampin and a tetracycline derivative.

21. The mesh pouch of claim 20, wherein at least one of said coatings comprises rifampin and minocycline HCl.

22. The mesh pouch of claim 14, wherein at least one of said coatings comprises an anti-inflammatory agent selected from non-selective cox-1 and cox-2 inhibitors

23. The mesh pouch of claim 14 wherein at least one of said coatings comprises an anti-inflammatory agent selected from selective cox-1 or cox-2 inhibitors.

24. The mesh pouch of any one of claims claim 1, 2 or 3, wherein said implantable device is a pacemaker, a defibrillator, a pulse generator, an implantable access system, a drug pump or a neurostimulator.

25. A kit comprising an implantable medical device unit and the mesh pouch of any one of claims 1, 2 or 3.

26. The kit of claim 25, wherein said medical device unit is a CRM device.

27. The kit of claim 25, wherein said medical device unit is a pacemaker, a defibrillator, a pulse generator, an implantable access system, a drug pump or a neurostimulator.

28. The kit of claim 25, wherein said one or more biodegradable polymers are selected from the group consisting of a polylactic acid, polyglycolic acid, poly(L-lactide), poly(D,L-lactide), polyglycolic acid, poly(L-lactide-co-D,L-lactide), poly(L-lactide-co-glycolide), poly(D, L-lactide-co-glycolide), poly(glycolide-co-trimethylene carbonate), poly(D,L-lactide-co-caprolactone), poly(glycolide-co-caprolactone), polyethylene oxide, polyoxaester, polydioxanone, polypropylene fumarate, poly(ethyl glutamate-co-glutamic acid), poly(tert-butyloxy-carbonylmethyl glutamate), polycaprolactone, polycaprolactone co-butylacrylate, polyhydroxybutyrate, poly(phosphazene), poly(phosphate ester), poly(amino acid), polydepsipeptide, maleic anhydride copolymer, polyiminocarbonates, poly[(97.5% dimethyl-trimethylene carbonate)-co-(2.5% trimethylene carbonate)], poly(orthoesters), tyrosine-derived polyarylate, tyrosine-derived polycarbonate, tyrosine-derived polyiminocarbonate, tyrosine-derived polyphosphonate, polyalkylene oxide, hydroxypropylmethylcellulose, polysaccharide, protein, and copolymers, terpolymers and blends of any thereof.

29. The kit of claim 25, wherein at least one of said biodegradable polymers comprise one or more tyrosine-derived diphenol monomer units.

30. The kit of claim 25, wherein said coating comprises one or more drugs are selected from the group consisting of antimicrobial agents, anesthetics, analgesics, anti-inflammatory agents, anti-scarring agents, anti-fibrotic agents and leukotriene inhibitors.

31. The kit of claim 30, wherein said drug is an anesthetic.

32. The kit of claim 30, wherein said drug is an antimicrobial agent.

33. The kit of claim 32, wherein said antimicrobial agent is selected from the group consisting of rifampin, minocycline, silver/chlorhexidine, vancomycin, a cephalosporin, gentamycin, triclosan and combinations thereof.

34. The kit of claim 32, comprising two antimicrobial agents, said agents being rifampin and a tetracycline derivative.