Anti-infective and antithrombogenic medical articles and method for their preparation

• US 4,999,210 A
• Filed: 12/07/1989
• Issued: 03/12/1991
• Est. Priority Date: 01/18/1989
• Status: Expired due to Term

• Current Assignee: Trustees Of Columbia University In The City Of New York (Columbia University)
• Original Assignee: Becton, Dickinson & Co
• Inventors: Solomon, Donald D., Byron, M. Parke
• Primary Examiner(s): Brown, Johnnie R.
• Assistant Examiner(s): Pili-Curtis, Carmen
• Application Number:
  US07/449,382
• Time in Patent Office: 460 Days
• Field of Search: 424/83, 424/78, 514/822, 523/122, 523/112, 604/266, 524/916, 524/195, 427/2
• US Class Current: 427/2.25
• CPC Class Codes: A61L 2300/104 Silver, e.g. silver sulfadiazine
• CPC Class Codes: A61L 2300/206 Biguanides, e.g. chlorohexidine
• CPC Class Codes: A61L 2300/406 Antibiotics
• CPC Class Codes: A61L 2300/42 Anti-thrombotic agents, anticoagulants, anti-platelet agents
• CPC Class Codes: A61L 2300/608 having two or more layers
• CPC Class Codes: A61L 29/06 obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds
• 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: A61M 2025/0056 provided with an antibacterial agent, e.g. by coating, residing in the polymer matrix or releasing an agent out of a reservoir
• CPC Class Codes: C08L 75/00 Compositions of polyureas or polyurethanes; Compositions of derivatives of such polymers
• CPC Class Codes: Y10S 524/916 Hydrogel compositions

Abstract

An anti-infective medical article has chlorhexidine bulk distributed throughout a polyurethane base layer and may have a coating layer on the base layer. The coating layer may be chlorhexidine, an antibiotic, or an antithrombogenic agent permeated into the surface or it may be a polymeric surface layer having bulk distributed chlorhexidine laminated onto the base layer. The invention includes a method for preparing the article wherein a homogeneous melt of polymer and chlorhexidine is prepared by twin screw compounding and the melt is extruded to give a medical article having bulk distributed chlorhexidine. The article may then be laminated by dipping into a solution of chlorhexidine and a substantially hydrophilic polymer in a solvent.

Claims

1. A method for preparing a medical article comprising:

a. extruding a first polymer having a water absorption of at least 0.6% by weight to obtain a shaped first polymer.

b. applying a laminated layer comprising a second polymer having a water absorption of at least 0.6% by weight and an antiinfective agent selected from the group consisting of a biguanide and silver sulfadiazine bulk distributed therein onto a surface of said shaped first polymer.

2. The method of claim 1 wherein said biguanide is chlorhexidine.

3. The method in accordance with claim 2 wherein said chlorhexidine is selected from the group consisting of chlorhexidine base and a salt thereof.

4. The method in accordance with claim 3 wherein said salt of chlorhexidine is selected from the group consisting of the hydrochloride, acetate and gluconate.

5. The method in accordance with claim 1 wherein said first and second polymers are selected from the group consisting of polyurethane, polyurethaneurea and siloxane-urethane block copolymer.

6. The method of claim 1 further comprising preparing a melt of said second polymer and said anti-infective agent by twin screw compounding and performing said applying step by dipping said shaped first polymer into said melt.

7. The method of claim 1 wherein said preparing step includes preparing a melt of said first polymer and said applying step includes preparing a homogeneous melt of said second polymer and said anti-infective agent and coextruding said melts.

8. The method of claim 1 further comprising preparing a solvent solution of said second polymer and said anti-infective agent and performing said applying step by dipping said shaped article into said solution.

9. The method in accordance with claim 1 further comprising permeating a quaternary ammonium salt into said laminated layer and reacting the permeated salt with a material selected from the group consisting of an antibiotic and an antithrombogenic agent.