Biodegradable, polymer coverings for breast implants

• US 8,911,765 B2
• Filed: 03/28/2008
• Issued: 12/16/2014
• Est. Priority Date: 03/29/2007
• Status: Active Grant

• Current Assignee: Medtronic Incorporated (Medtronic Plc)
• Original Assignee: TYRX, INC. (Medtronic Plc)
• Inventors: Moses, Arikha, Pulapura, Satish, Ge, Qing, Nethula, Sarita, Shatova, Irene, Rajaram, Archana
• Primary Examiner(s): Wax, Robert A
• Assistant Examiner(s): AL-AWADI, DANAH J
• Application Number:
  US12/058,060
• Publication Number:
  US 20080241212A1
• Time in Patent Office: 2,454 Days
• Field of Search: None
• US Class Current: 424/426
• 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 biodegradable covering comprising one or more biodegradable polymer layers with elastomeric properties said biodegradable covering having a T_g of less than about 40°

C., and an outer surface, an inner surface for non-adherent contact with an outer surface of said breast implant, and a flexible opening allowing insertion of said breast implant through said flexible opening into said biodegradable covering such that when said breast implant is disposed within said biodegradable covering said inner surface of said biodegradable covering is in contact with but not adhered to said breast implant, said one or more biodegradable polymer layers include one or more drugs consisting of antimicrobial agents, and at least one of an anesthetic and anti-inflammatory agent.

2. The biodegradable covering of claim 1, wherein said antimicrobial agent is selected from the group consisting of rifampin, minocycline, gentamicin, vancomycin, triclosan, novobiocin, cephalosporin, alone or in combination.

3. The biodegradable covering of claim 1, wherein said one or more drugs are rifampin and minocycline.

4. The biodegradable covering of claim 1, wherein said anesthetic is selected from the group consisting of lidocaine, bupivacaine, mepivacaine and xylocaine.

5. The biodegradable covering of claim 1 including a plurality of said biodegradable polymer layers, and wherein the layer forming said inner surface of said biodegradable covering is a drug impermeable, biodegradable barrier layer capable of preventing one or more drugs from contacting the breast implant when the breast implant is disposed within said biodegradable covering.

6. The biodegradable covering of claim 1, wherein said outer surface of said biodegradable covering is smooth or textured.

7. The biodegradable covering of claim 1, wherein said biodegradable covering is substantially encasing said breast implant.

8. The biodegradable covering of claim 1, wherein said biodegradable covering is dimensioned and shaped to form fit a round, teardrop or contoured shaped breast implant therein.

9. The biodegradable covering of claim 1, wherein one or more of said biodegradable polymer layers is constructed from a tyrosine-derived polyarylate.

10. The biodegradable covering of claim 1, wherein one or more of said biodegradable polymer layers is a synthetic tyrosine-containing polymer.

11. The biodegradable covering of claim 1, wherein one or more of said biodegradable polymer layers comprises a blend of polymers.

12. The biodegradable covering of claim 1, wherein said biodegradable covering is effective to inhibit or reduce formation of scar tissue in and around said breast implant or inhibits or reduces capsular contracture in and around said implant when said breast implant is disposed in said biodegradable covering, and implanted in a patient.

23. A kit comprising a breast implant and a biodegradable covering according to claim 1, 14, or 20.

24. The biodegradable claim 1 including a plurality of said biodegradable polymer layers, wherein the layer forming said inner surface of said biodegradable covering is free of said one or more drugs and the layer forming said outer surface of said biodegradable covering comprises said one or more drugs.

25. The biodegradable claim 24, wherein the layer forming said inner surface is a drug impermeable, biodegradable barrier layer capable of preventing one or more drugs from contacting the breast implant when the breast implant is disposed within said biodegradable covering.

26. The biodegradable claim 24, wherein the layer forming said inner surface is smooth and the layer forming said outer surface is textured.

27. The biodegradable claim 1 including a plurality of said biodegradable polymer layers, wherein the layer forming said inner surface is free of said one or more drugs, the layer forming said outer surface comprises said one or more drugs and one or more polymeric layers between the layer forming said inner surface and the layer forming said outer surface comprise said one or more drugs.

28. The biodegradable claim 1, wherein the T_g is in a range of about 20°

C. to about 30°

C.

29. The biodegradable claim 1, wherein said one or more biodegradable polymer layers comprises one to five layers.

13. A breast implant assembly comprising:

a biodegradable covering having elastomeric properties and a T_g of less than about 40°

C., said biodegradable covering include one or more drugs consisting of antimicrobial agents, and at least one of an anesthetic and anti-inflammatory agent; and

a breast implant, said breast implant and said biodegradable covering being preassembled such that said breast implant is disposed within at least a portion of said biodegradable covering, said biodegradable covering being in contact with but not adhered to said breast implant whereby said breast implant can move relative to said biodegradable covering when said breast implant is disposed within said biodegradable covering.

14. A biodegradable covering for a breast implant, said biodegradable covering comprising one or more biodegradable polymer layers comprising a sheet, film or mat of nanofibers, and including an outer surface and an inner surface for non-adherent contact with an outer surface of said breast implant, whereby said inner surface of said biodegradable covering can be in contact with but not adhered to said breast implant, said one or more biodegradable polymer layers include one or more drugs consisting of antimicrobial agents, and at least one of an anesthetic and anti-inflammatory agent.

15. The biodegradable covering of claim 14 wherein said one or more drugs is an antimicrobial agent.

16. The biodegradable covering of claim 15 wherein said antimicrobial agent is selected from the group consisting of rifampin, minocycline, gentamicin, vancomycin, triclosan, novobiocin, cephalosporin, alone or in combination.

17. The biodegradable covering of claim 14 wherein said one or more biodegradable polymer layers comprises a tyrosine-derived polyarylate.

18. The biodegradable covering of claim 14 wherein said one or more biodegradable polymers comprises a synthetic tyrosine-containing polymer.

19. The biodegradable covering of claim 14 wherein said one or more biodegradable polymer layers comprises electrospun nanofibers.

20. A biodegradable covering for a breast implant comprising a plurality of biodegradable polymer layers having elastomeric properties, said biodegradable covering having an outer surface, an inner surface for contact with an outer surface of said breast implant, and a flexible opening allowing insertion of said breast implant through said flexible opening in said biodegradable covering, said plurality of biodegradable polymer layers including a first biodegradable polymer layer comprising said inner surface and comprising a drug-impermeable biodegradable barrier layer for preventing drugs from contacting said breast implant when said breast implant is disposed within said biodegradable covering, and including at least one additional biodegradable polymer layer including one or more drugs whereby a predetermined drug release profile for said biodegradable covering can be provided wherein said one or more drugs consists of antimicrobial agents, and at least one of an anesthetic and anti-inflammatory agent.

21. The biodegradable covering of claim 20 wherein said at least one additional biodegradable polymer layer comprises a plurality of additional biodegradable polymer layers, each of said plurality of biodegradable polymer layers including one or more drugs incorporated therein.

22. The biodegradable polymer covering of claim 21 wherein said one or more drugs incorporated in each of said plurality of additional biodegradable polymer layers comprises a different drug.