Biodegradable, Polymer Coverings for Breast Implants

• US 20080241212A1
• Filed: 03/28/2008
• Published: 10/02/2008
• Est. Priority Date: 03/29/2007
• Status: Active Grant

• Current Assignee: Medtronic Incorporated (Medtronic Plc)
• Original Assignee: TYRX Pharma, Inc. (Medtronic Plc)
• Inventors: Ge, Qing, Pulapura, Satish, Moses, Arikha, Rajaram, Archana, Shatova, Irene, Nethula, Sarita
• Granted Patent: US 8,911,765 B2
• Time in Patent Office: Days
• US Class Current: 424/423
• CPC Class Codes: A61F 2/12 Mammary prostheses and implants
• CPC Class Codes: A61K 2300/00 Mixtures or combinations of active ingredients, wherein at least one active ingredient is fully defined in groups A61K31/00 - A61K41/00
• CPC Class Codes: A61K 31/167 having the nitrogen of a carboxamide group directly attached to the aromatic ring, e.g. lidocaine, paracetamol
• CPC Class Codes: A61K 31/381 having five-membered rings
• CPC Class Codes: A61K 31/404 Indoles, e.g. pindolol
• CPC Class Codes: A61K 31/41 having five-membered rings with two or more ring hetero atoms, at least one of which being nitrogen, e.g. tetrazole
• CPC Class Codes: A61K 31/445 Non condensed piperidines, e.g. piperocaine
• CPC Class Codes: A61K 31/47 Quinolines; Isoquinolines
• CPC Class Codes: A61K 31/496 Non-condensed piperazines containing further heterocyclic rings, e.g. rifampin, thiothixene or sparfloxacin
• CPC Class Codes: A61K 31/545 Compounds containing 5-thia-1-azabicyclo [4.2.0] octane ring systems, i.e. compounds containing a ring system of the formula: , e.g. cephalosporins, cefaclor, or cephalexine
• CPC Class Codes: A61K 31/65 Tetracyclines
• CPC Class Codes: A61K 31/7036 having at least one amino group directly attached to the carbocyclic ring, e.g. streptomycin, gentamycin, amikacin, validamycin, fortimicins
• CPC Class Codes: A61K 31/7048 having oxygen as a ring hetero atom, e.g. leucoglucosan, hesperidin, erythromycin, nystatin , digitoxin or digoxin
• CPC Class Codes: A61K 38/13 Cyclosporins
• CPC Class Codes: A61P 17/00 Drugs for dermatological disorders
• CPC Class Codes: A61P 29/00 Non-central analgesic, antipyretic or antiinflammatory agents, e.g. antirheumatic agents; Non-steroidal antiinflammatory drugs [NSAID]
• CPC Class Codes: B29C 41/14 Dipping a core B29C41/10 takes precedence

Abstract

A biodegradable, flexible covering for a breast implant is provided which comprises one or more biodegradable polymer layers dimensioned and shaped to cover at least a portion of the breast implant. The implant can be inserted into an opening of the covering immediately prior to surgery, but alternate configurations and times of insertion are contemplated as well as open or sheet type devices. The coverings can optionally contain one or more drugs for delivery at the surgical site, particularly for treating or preventing infection, pain, inflammation, capsular contracture, scarring or other complications associated with breast augmentation or breast reconstruction.

Claims

1. A biodegradable covering for a breast implant, said covering comprising one or more biodegradable polymer layers dimensioned and shaped to cover at least a portion of said breast implant and said covering having an outer surface, an inner surface and a peripheral edge defining a flexible opening for receiving said implant.

3. The covering of claim 1 which comprises a plurality of biodegradable layers.

4. The covering of any one of claims 1-3, wherein at least one layer comprises one or more drugs.

5. The covering of claim 4, wherein said one or more drugs is selected from the group consisting of antimicrobial agents, anesthetics, anti-inflammatory agents, anti-scarring agents, anti-fibrotic agents, anti-neoplastic agents, and leukotriene inhibitors.

6. The covering of claim 5, wherein said one or more drugs is an antimicrobial agent.

7. The covering of claim 6, wherein said an antimicrobial agent is selected from the group consisting of rifampin, minocycline, gentamicin, vancomycin, triclosan, novobiocin, cephalosporin, alone or in combination.

8. The covering of claim 5, wherein said drugs are rifampin and minocyline.

9. The covering of claim 4, wherein said one or more drugs is a leukotriene inhibitor.

10. The covering of claim 9, wherein said leukotriene inhibitor is a leukotriene receptor antagonist selected from the group consisting of acitazanolast, iralukast, montelukast, pranlukast, verlukast, zafirlukast, and zileuton.

11. The covering of claim 4, wherein said one or more drugs is an anesthetic.

12. The covering of claim 11, wherein said anesthetic is selected from the group consisting of lidocaine, bupivacaine, mepivacaine and xylocaine

13. The covering of claim 3, wherein the layer forming said inner surface comprises a drug impermeable, biodegradable barrier layer.

14. The covering of claims 1 or 2, wherein said outer surface is smooth or textured.

15. The covering of any one of claims 1-3, wherein said covering is capable of substantially encasing said breast implant.

16. The covering of any one of claims 1-3, wherein said covering is dimensioned and shaped to form fit a round, teardrop or contoured breast implant.

17. The covering of claim 16, wherein at least one layer comprises one or more drugs.

18. The covering of claim 17, wherein said one or more drugs is selected from the group consisting of antimicrobial agents, anesthetics, anti-inflammatory agents, anti-scarring agents, anti-fibrotic agents, anti-neoplastic agents, and leukotriene inhibitors.

19. The covering of claim 18, wherein said one or more drugs is an antimicrobial agent.

20. The covering of claim 19, wherein said an antimicrobial agent is selected from the group consisting of rifampin, minocycline, gentamicin, vancomycin, triclosan, novobiocin, cephalosporin, alone or in combination.

21. The covering of claim 20, wherein said drugs are rifampin and minocyline.

22. The covering of claim 17, wherein at least one of said biodegradable polymers is a tyrosine-derived polyarylate.

23. The covering of any one of claims 1-3, wherein at least one of said biodegradable polymers is a tyrosine-derived polyarylate or other synthetic tyrosine-containing polymer.

24. The covering of any one of claims 1-3 wherein said biodegradable polymer layer comprises a blend of polymers.

25. The covering of claim 1, wherein said biodegradable polymer covering inhibits or reduces formation of scar tissue in and around said implant and/or inhibits or reduces capsular contracture in and around said implant when implanted as a covering with a breast implant.

26. A kit comprising a breast implant and the biodegradable covering according to any one of claims 1-3.

27. A breast implant assembly comprising a biodegradable covering of any one of claims 1-3 containing a breast implant.

28. A method for reducing post-surgical complications from breast augmentation, breast reconstruction or breast restoration in a subject which comprises surgically implanting a breast implant assembly of claim 27 into said subject.

29. The method of claim 28, wherein said complication is selected from the group consisting of infection, inflammation, capsular contracture, scarring or excess scarring.

2. A biodegradable covering for a breast implant, said covering comprising a sheet, film or mat of nanofibers of one or more biodegradable polymer layers dimensioned and shaped to wrap or cover at least a portion of said breast implant.