Antimicrobial compositions and uses thereof

• US 8,906,364 B2
• Filed: 01/11/2006
• Issued: 12/09/2014
• Est. Priority Date: 07/01/2005
• Status: Expired due to Fees

• Current Assignee: Kane Biotech Inc.
• Original Assignee: Kane Biotech Inc.
• Inventors: Madhyastha, Srinivasa
• Primary Examiner(s): Bredefeld, Rachael E
• Assistant Examiner(s): Lazaro, Dominic
• Application Number:
  US11/331,423
• Publication Number:
  US 20070003538A1
• Time in Patent Office: 3,254 Days
• Field of Search: None
• US Class Current: 424/94.61
• CPC Class Codes: A01N 2300/00 Combinations or mixtures of active ingredients covered by classes A01N27/00 - A01N65/48 with other active or formulation relevant ingredients, e.g. specific carrier materials or surfactants, covered by classes A01N25/00 - A01N65/48
• CPC Class Codes: A01N 37/46 N-acyl derivatives
• CPC Class Codes: A01N 47/44 Guanidine; Derivatives thereof
• CPC Class Codes: A01N 61/00 Biocides, pest repellants or attractants, or plant growth regulators containing substances of unknown or undetermined composition, e.g. substances characterised only by the mode of action
• 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 31/155 Amidines (), e.g. guanidine (H2N—C(=NH)—NH2), isourea (N=C(OH)—NH2), isothiourea (—N=C(SH)—NH2)
• CPC Class Codes: A61K 38/17 from animals; from humans enzyme inhibitors A61K38/005
• CPC Class Codes: A61L 12/082 in combination with specific enzymes
• CPC Class Codes: A61L 12/141 Biguanides, e.g. chlorhexidine
• CPC Class Codes: A61L 12/145 Polymeric quaternary ammonium compounds
• CPC Class Codes: A61L 2/16 using chemical substances
• CPC Class Codes: A61L 2/18 Liquid substances or solutions comprising solids or dissolved gases
• CPC Class Codes: A61L 2/22 Phase substances, e.g. smokes, aerosols or sprayed or atomised substances
• CPC Class Codes: A61L 2300/206 Biguanides, e.g. chlorohexidine
• CPC Class Codes: A61L 2300/252 Polypeptides, proteins, e.g. glycoproteins, lipoproteins, cytokines
• CPC Class Codes: A61L 2300/404 Biocides, antimicrobial agents, antiseptic agents
• CPC Class Codes: A61L 2300/42 Anti-thrombotic agents, anticoagulants, anti-platelet agents
• CPC Class Codes: A61L 27/34 Macromolecular materials
• CPC Class Codes: A61L 29/044 Proteins; Polypeptides; Degradation products thereof
• CPC Class Codes: A61L 29/085 Macromolecular materials
• CPC Class Codes: A61L 29/16 : Biologically active materials, e.g. therapeutic substances A61L29/048 takes precedence
• CPC Class Codes: A61P 13/02 : of urine or of the urinary tract, e.g. urine acidifiers
• CPC Class Codes: A61P 31/02 : Local antiseptics
• CPC Class Codes: A61P 31/04 : Antibacterial agents
• CPC Class Codes: C08L 89/00 : Compositions of proteins; Compositions of derivatives thereof foodstuff preparations A23J3/00
• CPC Class Codes: Y02A 50/30 : Against vector-borne diseases, e.g. mosquito-borne, fly-borne, tick-borne or waterborne diseases whose impact is exacerbated by climate change

Abstract

The present invention provides compositions for preventing growth and proliferation of biofilm embedded microorganisms on devices comprising: (a) a cationic polypeptide and (b) a bis-guanide or a salt thereof. The invention further provides methods for preparing medical devices with such compositions.

Claims

1. An insertable or implantable medical device comprising

a coated external surface of said medical device, wherein said coated external surface comprises at least two layers of a composition comprising (a) protamine sulfate and (b) chlorhexidine or a salt thereof.

2. The medical device according to claim 1 prepared by a process comprising:

a) contacting the external surface of the medical device with a solution of i) about 10 mg/ml to about 200 mg/ml of protamine sulfate and ii) about 100 mg/ml to about 400 mg/ml of chlorhexidine or a salt thereof;

b) drying the medical device; and

c) sterilizing the medical device.

3. The medical device according to claim 1, wherein the chlorhexidine salt is selected from the group consisting of chlorhexidine diglucanate, chlorhexidine diacetate, and chlorhexidine dihydrochloride.

4. The medical device according to claim 1, further comprising at least one ingredient selected from the group consisting of:

a binding, bonding, or coupling agent;

a bis-phenol;

a quaternary ammonium compound;

a maleimide;

an antibiotic; and

a pH adjuster.

5. The medical device of claim 1, wherein the medical device is an indwelling catheter.

6. The medical device of claim 5, wherein the indwelling catheter is a central venous catheter, dialysis catheter, long term tunneled central venous catheters, short-term central venous catheters, peripherally inserted central catheters, peripheral venous catheters, pulmonary artery Swan-Ganz catheters, urinary catheters, or peritoneal catheter.

7. The medical device of claim 1, where the medical device is a long-term urinary device, tissue bonding urinary device, vascular catheter port, wound drain tube, hydrocephalus shunt, heart valve, heart assist device, cannula, intravenous tube, breathing tube, feeding tube, or orthopedic implant.

8. An implantable or insertable medical device comprising (a) protamine sulfate and (b) chlorhexidine or a salt thereof incorporated into an external surface of said medical device.

9. The medical device according to claim 8, wherein the chlorhexidine salt is selected from the group consisting of chlorhexidine diglucanate, chlorhexidine diacetate, and chlorhexidine dihydrochloride.

10. The medical device according to claim 8, further comprising at least one ingredient selected from the group consisting of:

a binding, bonding, or coupling agent;

a bis-phenol;

a quaternary ammonium compound;

a maleimide;

an antibiotic; and

a pH adjuster.

11. The medical device of claim 8, wherein the medical device is an indwelling catheter.

12. The medical device of claim 11, wherein the indwelling catheter is a central venous catheter, dialysis catheter, long term tunneled central venous catheters, short-term central venous catheters, peripherally inserted central catheters, peripheral venous catheters, pulmonary artery Swan-Ganz catheters, urinary catheters, or peritoneal catheter.

13. The medical device of claim 8, where the medical device is a long-term urinary device, tissue bonding urinary device, vascular catheter port, wound drain tube, hydrocephalus shunt, heart valve, heart assist device, cannula, intravenous tube, breathing tube, feeding tube, or orthopedic implant.