Medical implant having a durable, resilient and effective antimicrobial coating

• US 5,853,745 A
• Filed: 03/26/1997
• Issued: 12/29/1998
• Est. Priority Date: 11/08/1995
• Status: Expired due to Term

• Current Assignee: Baylor College of Medicine (Baylor College)
• Original Assignee: Baylor College of Medicine (Baylor College)
• Inventors: Darouiche, Rabih O.
• Primary Examiner(s): DUDASH, DIANA L
• Application Number:
  US08/824,596
• Time in Patent Office: 643 Days
• Field of Search: 623/1, 623/3, 623/4, 623/9, 623/11, 623/12, 623/901, 604/264, 604/265, 424/423, 424/424, 424/405
• US Class Current: 424/423
• CPC Class Codes: A61F 2/30767 Special external or bone-contacting surface, e.g. coating for improving bone ingrowth
• CPC Class Codes: A61F 2002/3007 Coating or prosthesis-covering structure made of elastic material, e.g. of elastomer
• CPC Class Codes: A61F 2002/30677 Means for introducing or releasing pharmaceutical products, e.g. antibiotics, into the body
• CPC Class Codes: A61F 2002/30929 having at least two superposed coatings
• CPC Class Codes: A61L 27/26 Mixtures of macromolecular compounds
• CPC Class Codes: A61L 27/28 Materials for coating prostheses
• CPC Class Codes: A61L 27/34 Macromolecular materials
• CPC Class Codes: A61L 27/54 Biologically active materials, e.g. therapeutic substances A61L27/227 takes precedence
• CPC Class Codes: C08L 1/18 Cellulose nitrate , i.e. nitrocellulose
• CPC Class Codes: C08L 29/00 Compositions of homopolymers or copolymers of compounds having one or more unsaturated aliphatic radicals, each having only one carbon-to-carbon double bond, and at least one being terminated by an alcohol, ether, aldehydo, ketonic, acetal or ketal radical; Compositions of hydrolysed polymers of esters of unsaturated alcohols with saturated carboxylic acids; Compositions of derivatives of such polymers
• CPC Class Codes: C08L 29/04 Polyvinyl alcohol; Partially hydrolysed homopolymers or copolymers of esters of unsaturated alcohols with saturated carboxylic acids
• CPC Class Codes: C08L 29/14 Homopolymers or copolymers of acetals or ketals obtained by polymerisation of unsaturated acetals or ketals or by after-treatment of polymers of unsaturated alcohols
• CPC Class Codes: C08L 31/04 Homopolymers or copolymers of vinyl acetate
• CPC Class Codes: C08L 77/06 Polyamides derived from polyamines and polycarboxylic acids C08L77/10 takes precedence

Abstract

A medical implant, such as an orthopedic implant, having a first antimicrobial coating layer and a second protective layer, and a method for coating such an implant is provided. The medical implant has one or more of its surfaces coated with an antimicrobial coating layer and a protective coating layer formed over the antimicrobial coating layer. The protective coating layer includes a durable coating layer composed of material such as collodion and nylon, and a resilient coating layer composed of material such as collodion. The coating layers are applied by applying an antimicrobial coating layer to at least a portion of the surfaces of the medical implant, applying a durable coating layer over the antimicrobial coating layer, and applying a resilient coating layer over the durable coating layer.

Claims

1. A medical implant having at least one of its surfaces coated with a composition comprised of:

an antimicrobial coating layer having an antimicrobial agent in an effective concentration to inhibit the growth of bacterial and fungal organisms relative to uncoated medical implant; and

a protective coating formed over said antimicrobial coating layer, wherein said protective coating is comprised of;

a durable coating layer; and

a resilient coating layer; and

wherein said resilient coating layer is comprised of collodion.

2. A medical implant having at least one of its surfaces coated with a composition comprised of:

an antimicrobial coating layer having an antimicrobial agent in an effective concentration to inhibit the growth of bacterial and fungal organisms relative to uncoated medical implant; and

a protective coating formed over said antimicrobial coating layer, wherein said protective coating is comprised of;

a durable coating layer; and

a resilient coating layer; and

wherein said durable coating layer is comprised of a mixture of collodion and nylon, and said material of said resilient coating layer is comprised of collodion.

3. A medical implant having at least one of its surfaces coated with a composition comprised of:

an antimicrobial coating layer having an antimicrobial agent in an effective concentration to inhibit the growth of bacterial and fungal organisms relative to uncoated medical implant; and

further wherein said antimicrobial coating layer coats at least one surface of said medical implant, wherein the antimicrobial coating layer includes polyvinyl butyryl-co-vinyl alcohol co-vinyl acetate dissolved in a 50;

50 solution of glacial acetic acid and formic acid and a mixture of antimicrobial compounds selected from the group of mixtures consisting of minocycline and rifampin;

chlorhexidine, methylisothiazolone and thymol;

chlorhexidine, α

-terpineol and methylisothiazolone;

thymol and chloroxylenol;

methylisothiazolone and thymol;

chlorhexidine and chloroxylenol; and

chlorhexidine and cetylpyridinium chloride, and wherein the compounds in said mixture are in an effective concentration to inhibit the growth of bacterial and fungal organisms relative to uncoated medical implant;

a protective coating formed over said antimicrobial coating layer;

a durable coating layer selected from the group consisting of nylon, a mixture of collodion and nylon, and a mixture of polyvinyl and nylon covering said antimicrobial coating layer; and

a resilient coating layer of collodion covering said durable coating layer.

4. A medical implant having at least one of its surfaces coated with a composition comprised of:

an antimicrobial coating layer having an antimicrobial agent in an effective concentration to inhibit the growth of bacterial and fungal organisms relative to uncoated medical implant;

wherein said antimicrobial coating layer coats at least one surface of said medical implant, wherein the antimicrobial coating layer includes polyvinyl butyryl-co-vinyl alcohol co-vinyl acetate dissolved in glacial acetic acid or a 50;

50 solution of glacial acetic acid and formic acid and a mixture of antimicrobial compounds selected from the group of mixtures consisting of minocycline and rifampin;

chlorhexidine, methylisothiazolone and thymol;

chlorhexidine, α

-terpineol and methylisothiazolone;

thymol and chloroxylenol;

methylisothiazolone and thymol;

chlorhexidine and chloroxylenol; and

chlorhexidine and cetylpyridinium chloride, wherein the compounds in said mixture are in an effective concentration to inhibit the growth of bacterial and fungal organisms relative to uncoated medical implant;

a protective coating formed over said antimicrobial coating layer;

a resilient coating layer of collodion covering said antimicrobial coating layer; and

a durable coating layer selected from the group consisting of nylon, a mixture of collodion and nylon, and a mixture of polyvinyl and nylon covering said resilient layer.