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

Assignee: Columbia University
•
Filing: 1989-01-18
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Granted: 1990-05-15
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Expires: 2009-01-18
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Abstract

Abstract A substantially hydrophilic polymeric medical article has a coating of chlorhexidine and a silicone on its surface and may have chlorhexidine bulk distributed throughout the polymer. The invention includes a method for preparing the article which includes dipping the article into a solution of chlorhexidine and silicone in a solvent. The method may also include preparing a melt of a substantially hydrophilic polymer having bulk distributed chlorhexidine by twin screw compounding a mixture of polymer and chlorhexidine and extruding the melt into the shape of the desired article prior to applying the coating.

Inventors

  • 👤 Mohammad A. Khan
  • 👤 Donald D. Solomon
  • 👤 Matthew P. Byron

Bibliographic Details

Application Number —
Jurisdiction US
Data Source google_patents
Last Synchronized 2026-10-23 13:40
CPC Classifications
A; A61; A61M; A61M39/00; A61M39/10; A61M39/16; A61M39/162; A61L; A61L29/00; A61L29/04; A61L29/06; A61L29/08; A61L29/085; A61L29/14; A61L29/16; A61L2300/00; A61L2300/20; A61L2300/204; A61L2300/206; A61L2300/40; A61L2300/404; A61L2300/452; A61M2039/0036

Claims Analysis

Total Claims: 25
Claim 1
Independent Claim 114 words
A method for preparing a medical article comprising: (a) preparing a blend of a first increment of chlorhexidine and pellets of a substantially hydrophilic polymer selected form the group consisting of polyurethane, polyurethaneurea and siloxane-urethane block copolymer; (b) heating said blend to a sufficient temperature and for a sufficient time to form a homogeneous melt of said polymer having said first increment of chlorhexidine uniformly distributed therein; (c) extruding said melt through a die to form a medical article having said first increment of chlorhexidine bulk distributed throughout said polymer; and (d) applying a coating of silicone lubricant and a second increment of chlorhexidine to the surface of said article having bulk distributed chlorhexidine.
Claim 2
Independent Claim 114 words
A method for preparing a medical article comprising: (a) preparing a blend of a first increment of chlorhexidine and pellets of a substantially hydrophilic polymer selected form the group consisting of polyurethane, polyurethaneurea and siloxane-urethane block copolymer; (b) heating said blend to a sufficient temperature and for a sufficient time to form a homogeneous melt of said polymer having said first increment of chlorhexidine uniformly distributed therein; (c) extruding said melt through a die to form a medical article having said first increment of chlorhexidine bulk distributed throughout said polymer; and (d) applying a coating of silicone lubricant and a second increment of chlorhexidine to the surface of said article having bulk distributed chlorhexidine.
Claim 3
Dependent Claim 35 words
The method in accordance with claim 1 wherein said first and second increments of chlorhexidine are selected from the group consisting of chlorhexidine base and about 1 to 10% by weight of a salt thereof.
Claim 4
Dependent Claim 11 words
An article produced in accordance with the method of claim 1.
Claim 5
Dependent Claim 16 words
The method in accordance with claim 1 wherein said polymer absorbs at least 0.6% of water.
Claim 6
Dependent Claim 36 words
The method in accordance with claim 1 wherein said applying step is performed by dipping said article having bulk distributed chlorhexidine into a solution of said silicone and said second increment of chlorhexidine in a solvent.
Claim 7
Dependent Claim 24 words
The method in accordance with claim 5 wherein said solvent is selected from the group consisting of ethanol, isopropanol, hexane, dichloro-difluoromethane and mixtures thereof.
Claim 8
Dependent Claim 16 words
The method in accordance with claim 1 wherein said melt is formed by twin screw compounding.
Claim 9
Dependent Claim 19 words
The method in accordance with claim 1 further comprising wetting said pellets with a polyol prior to said preparing.
Claim 10
Independent Claim 45 words
A method for rendering a medical article fabricated from a polymer selected form the group consisting of polyurethane, polyurethaneurea and siloxane-urethane block copolymer both lubricious and anti-infective comprising applying to a surface of said article a coating comprising a silicone lubricant and an anti-infective agent.
Claim 11
Independent Claim 45 words
A method for rendering a medical article fabricated from a polymer selected form the group consisting of polyurethane, polyurethaneurea and siloxane-urethane block copolymer both lubricious and anti-infective comprising applying to a surface of said article a coating comprising a silicone lubricant and an anti-infective agent.
Claim 12
Independent Claim 125 words
A method for preparing a medical article comprising: (a) preparing a blend of pellets of a substantially hydrophilic polymer selected from the group consisting of polyurethane, polyurethaneurea and siloxane-urethane block copolymer and about 1 to 10% by weight of a first increment of a salt of chlorhexidine; (b) forming a homogeneous melt by twin screw compounding said blend at a temperature of at least 160° C.; (c) extruding said melt through a die to form a medical article having said chlorhexidine salt bulk distributed throughout said polymer; and (d) dipping said medical article having said first increment of chlorhexidine bulk distributed therein into a solution of a silicone lubricant and a second increment of a chlorhexidine salt to form a coating on said medical article.
Claim 13
Independent Claim 125 words
A method for preparing a medical article comprising: (a) preparing a blend of pellets of a substantially hydrophilic polymer selected from the group consisting of polyurethane, polyurethaneurea and siloxane-urethane block copolymer and about 1 to 10% by weight of a first increment of a salt of chlorhexidine; (b) forming a homogeneous melt by twin screw compounding said blend at a temperature of at least 160° C.; (c) extruding said melt through a die to form a medical article having said chlorhexidine salt bulk distributed throughout said polymer; and (d) dipping said medical article having said first increment of chlorhexidine bulk distributed therein into a solution of a silicone lubricant and a second increment of a chlorhexidine salt to form a coating on said medical article.
Claim 14
Dependent Claim 48 words
A medical article comprising a substantially hydrophilic polymer selected from the group consisting of polyurethane, polyurethaneurea and siloxane-urethane block copolymer and a coating thereon, said polymer having a first increment of chlorhexidine bulk distributed throughout and said coating comprising a second increment of chlorhexidine and a silicone lubricant.
Claim 15
Dependent Claim 48 words
A medical article comprising a substantially hydrophilic polymer selected from the group consisting of polyurethane, polyurethaneurea and siloxane-urethane block copolymer and a coating thereon, said polymer having a first increment of chlorhexidine bulk distributed throughout and said coating comprising a second increment of chlorhexidine and a silicone lubricant.
Claim 16
Dependent Claim 33 words
The article of claim 11 wherein said first and second increments of chlorhexidine are selected from the group consisting of chlorhexidine base and about 1 to 10% by weight of a chlorhexidine salt.
Claim 17
Dependent Claim 11 words
An article produced in accordance with the method of claim 9.
Claim 18
Dependent Claim 16 words
The article of claim 11 wherein said polymer absorbs at least 0.6% by weight of water.
Claim 19
Dependent Claim 31 words
A medical article comprising a substantially hydrophilic polymer selected from the group consisting of polyurethanes, polyurethaneurea and siloxane-urethane block copolymer and a coating of an anti-infective agent and a silicone lubricant.
Claim 20
Dependent Claim 31 words
A medical article comprising a substantially hydrophilic polymer selected from the group consisting of polyurethanes, polyurethaneurea and siloxane-urethane block copolymer and a coating of an anti-infective agent and a silicone lubricant.
Claim 21
Dependent Claim 37 words
A medical article comprising a polyurethane having a coating thereon, said polyurethane having about 0.1 to 10% by weight of a salt of chlorhexidine bulk distributed throughout, said coating comprising a chlorhexidine salt and a silicone lubricant.
Claim 22
Dependent Claim 37 words
A medical article comprising a polyurethane having a coating thereon, said polyurethane having about 0.1 to 10% by weight of a salt of chlorhexidine bulk distributed throughout, said coating comprising a chlorhexidine salt and a silicone lubricant.
Claim 23
Dependent Claim 9 words
The article of claim 16 which is a catheter.
Claim 24
Dependent Claim 10 words
The article of claim 16 which is a drainage bag.
Claim 25
Dependent Claim 11 words
An article produced in accordance with the method of claim 10.

References Cited (Backward Citations)

US4117035A Cited
US4186745A Cited
US4460369A Cited
US4604412A Cited
US4675347A Cited
US4806621A Cited

USPTO Annuity & Maintenance Windows

Annuity Stage Window Opens Payment Deadline Surcharge Period Until Estimated Fee Status
3.5 Years (Year 4) 1993-05-14 1993-11-13 1994-05-15 $2000.00 Window Closed / Lapsed
7.5 Years (Year 8) 1997-05-14 1997-11-13 1998-05-15 $3760.00 Window Closed / Lapsed
11.5 Years (Year 12) 2001-05-14 2001-11-13 2002-05-15 $7700.00 Window Closed / Lapsed

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