Antimicrobial wraps for medical implants

• US 9,849,217 B2
• Filed: 04/17/2014
• Issued: 12/26/2017
• Est. Priority Date: 04/18/2013
• Status: Active Grant

• Current Assignee: Board of Regents of the University of Texas System (University of Texas System)
• Original Assignee: Board of Regents of the University of Texas System (University of Texas System)
• Inventors: Rosenblatt, Joel, Raad, Issam, Dennis, Andrew P.
• Primary Examiner(s): Gherbi, Suzette J
• Application Number:
  US14/784,697
• Publication Number:
  US 20160074559A1
• Time in Patent Office: 1,349 Days
• Field of Search: 623 7- 8
• CPC Class Codes: A61F 2/12 Mammary prostheses and implants
• CPC Class Codes: A61F 2250/0018 differing in elasticity, stiffness or compressibility
• CPC Class Codes: A61F 2250/0057 made from both cured and uncured parts
• CPC Class Codes: A61F 2250/006 modular
• CPC Class Codes: A61F 2250/0067 Means for introducing or releasing pharmaceutical products into the body
• CPC Class Codes: A61L 2300/404 Biocides, antimicrobial agents, antiseptic agents
• CPC Class Codes: A61L 2430/04 for mammary reconstruction
• CPC Class Codes: A61L 27/222 Gelatin
• CPC Class Codes: A61L 27/502 Plasticizers
• CPC Class Codes: A61L 27/52 Hydrogels or hydrocolloids
• CPC Class Codes: A61L 27/54 Biologically active materials, e.g. therapeutic substances A61L27/227 takes precedence
• CPC Class Codes: A61M 27/00 Drainage appliance for wounds or the like , i.e. wound drains, implanted drains negative pressure wound therapy devices A61M1/90; implements for holding wound open A61B17/02 ; middle ear drainage A61F11/202

Abstract

Biodegradable antimicrobial films are provided that are solid at room temperature and substantially liquefy in situ after implantation into a mammal, such as a human patient. Methods of using the films to cover a medical device, such as a breast implant, prior to insertion into a subject are also provided.

Claims

1. A biodegradable covering for a medical implant, the covering comprising a highly plasticized gelatin and at least one drug to reduce infection or capsular contraction, wherein the plasticized gelatin has a melting temperature of less than 38°

C., and wherein the plasticized gelatin consists essentially of gelatin and from greater than 40% to about 60% plasticizer.

2. The covering of claim 1, wherein the plasticized gelatin has a melting temperature of 27-37°

C.

3. The covering of claim 1, wherein the plasticized gelatin has a melting temperature of 30-37°

C.

4. The covering of claim 2, wherein the plasticized gelatin comprises about 50-55% plasticizer.

5. The covering of claim 4, wherein the plasticizer is glycerol, a propylene glycol, a sugar, a carbohydrate, an amino acid, a salt, an acid, or a polyol.

6. The covering of claim 5 wherein the plasticizer is glycerol.

8. The covering of claim 1, wherein at least a portion of a surface of the covering has been treated with a glycerol-gelatin liquid comprising about 60-90% glycerol or a solution comprising a carbohydrate, a starch, or a sugar.

9. The covering of claim 1, wherein the covering is sufficient in size or shaped to cover a breast implant.

10. The covering of claim 9, wherein the covering is shaped as a film, a wrap, a pouch or a bag.

12. The covering of claim 1, wherein the covering comprises a plurality of biodegradable layers.

13. The covering of claim 1, wherein the at least one drug is selected from the group consisting of an antimicrobial agent, an anti-inflammatory agent, an anti-scarring agent, a hemostatic agent, an anti-neoplastic agent, a calcium channel blocker, and a leukotriene inhibitor.

14. The covering of claim 13, wherein the at least one drug is an antimicrobial agent.

15. The covering of claim 14, wherein the antimicrobial agent is bacitracin, cephalexin, gentamicin, an antiseptic, a chelator, chlorhexidine, gendine, gardine, a leukotriene inhibitor, hydrogen peroxide, a nitroglycerin, or a nitric oxide donor.

16. The covering of claim 1, wherein the covering comprises at least one of mercaptoethane sulfonate (MeSNA), minocycline, rifampin, or glyceryl trinitrate (GTN).

17. The covering of claim 16, wherein the covering comprises at least two of mercaptoethane sulfonate (MeSNA), minocycline, rifampin, and/or glyceryl trinitrate (GTN).

18. The covering of claim 17, wherein the covering comprises minocycline, rifampin, and mercaptoethane sulfonate.

23. The covering of claim 1, wherein at least a portion of the covering has been exposed to crosslinking.

26. The covering of claim 1, wherein the covering comprises multiple layers.

29. A kit comprising a breast implant and the biodegradable covering of claim 1.

30. A breast implant assembly comprising a biodegradable covering of claim 1 containing a breast implant.

31. A method for reducing at least one post-surgical indication from breast augmentation or breast reconstruction in a subject, the method comprising surgically implanting into the subject the breast implant assembly of claim 30.

32. A transcutaneous device assembly comprising a biodegradable covering of claim 1 that is wrapped around at least a portion of the transcutaneous device.

33. A method for reducing at least one post-surgical indication from implantation of a transcutaneous device in a subject, the method comprising surgically implanting into the subject the transcutaneous device assembly of claim 32.

7. A biodegradable covering for a medical implant, the covering comprising a highly plasticized gelatin and at least one drug to reduce infection or capsular contraction, wherein the plasticized gelatin has a melting temperature of less than 38°

C., wherein at least a portion of a surface of the covering has been treated with a gluconic acid solution.

11. A biodegradable covering for a medical implant, the covering comprising a highly plasticized gelatin and at least one drug to reduce infection or capsular contraction, wherein the plasticized gelatin has a melting temperature of less than 38°

C.;

wherein the covering is sufficient in size or shaped to cover a breast implant;

wherein the covering is shaped as a film, a wrap, a pouch or a bag; and

wherein the covering is a pouch or a bag;

wherein the covering has a central region and a plurality of lateral appendages, or the covering is substantially star-shaped.

19. A biodegradable covering for a medical implant, the covering comprising a highly plasticized gelatin and at least one drug to reduce infection or capsular contraction, wherein the plasticized gelatin has a melting temperature of less than 38°

C.;

wherein the covering comprises minocycline, rifampin, and mercaptoethane sulfonate; and

wherein the covering further comprises glyceryl trinitrate (GTN), a monoglyceride, or a fatty acid.

20. The covering of claim 19, wherein the fatty acid is a C_6-12 alkanoic acid.

21. The covering of claim 20, wherein the fatty acid is caprylic acid (octanoic acid).

22. The covering of claim 19, wherein the covering further comprises glyceryl trinitrate (GTN) and caprylic acid.

24. A biodegradable covering for a medical implant, the covering comprising a highly plasticized gelatin and at least one drug to reduce infection or capsular contraction, wherein the plasticized gelatin has a melting temperature of less than 38°

C.;

wherein at least a portion of the covering has been exposed to crosslinking; and

wherein the covering comprises regions that have been exposed to crosslinking and regions that have not been exposed to crosslinking.

25. The covering of claim 24, wherein the regions that have not been exposed to crosslinking comprise minocycline, rifampin, glyceryl trinitrate (GTN), mercaptoethane sulfonate (MeSNA), or caprylic acid.

27. A biodegradable covering for a medical implant, the covering comprising a highly plasticized gelatin and at least one drug to reduce infection or capsular contraction, wherein the plasticized gelatin has a melting temperature of less than 38°

C.;

wherein the covering comprises multiple layers; and

wherein the covering comprises a first layer comprising a partially crosslinked plasticized gelatin and a second layer comprising a plasticized gelatin that has not been crosslinked, wherein the second layer comprises the drug.

28. A biodegradable covering for a medical implant, the covering comprising a highly plasticized gelatin and at least one drug to reduce infection or capsular contraction, wherein the plasticized gelatin has a melting temperature of less than 38°

C.;

wherein the highly plasticized gelatin is comprised on an adhesive backing.