Antimicrobial wraps for medical implants

• US 10,434,221 B2
• Filed: 11/21/2017
• Issued: 10/08/2019
• 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:
  US15/820,154
• Publication Number:
  US 20180093018A1
• Time in Patent Office: 686 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; and

wherein the covering comprises a plurality of voids or holes.

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

C.

3. The covering of claim 1, wherein the plasticized gelatin comprises about 31-60% plasticizer.

4. The covering of claim 1, wherein the plasticizer is glycerol.

5. The covering of claim 1, wherein at least a portion of a surface of the covering has been treated with a gluconic acid solution.

6. 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.

7. The covering of claim 1, wherein the covering is shaped as a film, a wrap, a pouch or a bag.

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

9. 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.

10. The covering of claim 6, wherein the at least one drug is an antimicrobial agent, and 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.

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

12. The covering of claim 1, wherein covering further comprises a C_6-12 alkanoic acid.

13. The covering of claim 12, wherein the C_6-12 alkanoic acid is caprylic acid (octanoic acid).

14. The covering of claim 1, wherein the covering further comprises glyceryl trinitrate (GTN) and capyrilic acid.

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

16. The covering claim 1, wherein the covering has multiple layers.

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

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

19. The covering of claim 1, wherein the plurality of voids or holes are circular or oval in shape.

20. The covering of claim 1, wherein the plurality of voids or holes are in a sponge-like pattern.