US2008125857A1PendingUtilityA1

Hemocompatible polymers on hydrophobic porous polymers

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Assignee: ADVANCED CARDIOVASCULAR SYSTEMPriority: Oct 31, 2000Filed: Jan 28, 2008Published: May 29, 2008
Est. expiryOct 31, 2020(expired)· nominal 20-yr term from priority
Inventors:Wouter E. RoordaNiraj ShahAndre-Jean Lundkvist
A61L 31/16A61L 31/10A61L 2300/42A61L 27/34A61L 2300/236A61L 2300/208A61L 33/0011A61L 31/08A61L 31/048A61L 31/146
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Claims

Abstract

Various embodiments of the present invention provide a medical device comprising at least one blood-contacting surface comprising a porous hydrophobic polymer substrate, wherein at least a portion of the at least one blood-contacting surface comprises a hemocompatible polymer substrate. One embodiment of the present invention relates to the providing of expanded poly(tetrafluoroethylene) with one or more complexes of heparin, typically containing heparin in combination with a hydrophobic counter ion. The hemocompatible substance is dissolved in a mixture of solvents in which a first solvent wets the polymer substrate to be coated and the second solvent enhances the solubility of the hemocompatible substance material in the solvent mixture. Typical first solvents wetting a hydrophobic polymer substrate include non-polar such as hydrocholorofluorocarbons. Typical second solvents include polar solvents such as organic alcohols and ketones. Azeotropic mixtures of the second solvent in the first solvent are used in some embodiments of the present invention although second solvents may be employed in a range of concentration ranges from less than 0.1% up to saturation.

Claims

exact text as granted — not AI-modified
1 . A medical device, comprising at least one blood-contacting surface comprising a porous hydrophobic polymer substrate, wherein at least a portion of the at least one blood-contacting surface comprises a hemocompatible polymer substrate produced by:
 a) providing a hemocompatible substance,   b) preparing a solution comprising a mixture of:
 first solvent that wets the porous hydrophobic polymer substrate; 
 a second solvent that enhances the solubility of the hemocompatible substance in the solution; and 
 the hemocompatible substance; and, 
   c) contacting the surface of the porous hydrophobic polymer substrate with the solution thereby causing the hemocompatible substance to deposit onto the surface of the porous hydrophobic polymer substrate,   provided that the hemocompatible substance is not subjected to a dialdehyde cross-linking or dialdehyde stabilization step before in vivo use.   
   
   
       2 . The medical device of  claim 1  wherein the medical device is a stent. 
   
   
       3 . The medical device of claim I wherein the porous hydrophobic polymer substrate composes a blood-contacting component of a medical device. 
   
   
       4 . The medical device of claim I wherein the porous hydrophobic polymer substrate includes at least one polymer material selected from the group consisting of porous polyethylene materials, porous polypropylene materials, porous polyurethane materials, porous polyacrylate materials, porous polymethacrylate materials and porous fluoropolymer materials. 
   
   
       5 . The medical device of  claim 4  wherein the porous fluoropolymer material comprises an expanded poly(tetrafluoroethylene) material. 
   
   
       6 . The medical device of  claim 1  wherein the hemocompatible substance comprises ionic heparin and a hydrophobic counter ion. 
   
   
       7 . The medical device of  claim 6  wherein the hydrophobic counter ion is a hydrophobic quaternary ammonium ion. 
   
   
       9 . The medical device of  claim 6  wherein the hydrophobic counter ion is one or more of benzylalkonium ion and tridodecylmethylammonium ion. 
   
   
       10 . The medical device of  claim 1  wherein the hemocompatible substance is deposited on the hydrophobic polymer substrate by dipping. 
   
   
       11 . The medical device of  claim 10  wherein the second solvent particularly enhances solubility of the hemocompatible substance. 
   
   
       12 . A medical device, comprising at least one blood-contacting surface comprising a porous hydrophobic polymer substrate, wherein at least a portion of the at least one blood-contacting surface comprises a hemocompatible polymer substrate produced by:
 a) providing a hemocompatible substance,   b) preparing a solution comprising a mixture of:
 a first solvent that wets the porous hydrophobic polymer substrate; 
 a second solvent that particularly enhances the solubility of the hemocompatible substance in the solution; and 
 the hemocompatible substance; and 
   c) contacting the surface of the porous hydrophobic polymer substrate with the solution thereby causing the hemocompatible substance to deposit onto the surface of the porous hydrophobic polymer.   
   
   
       13 . The medical device of  claim 12  wherein the medical device is a stent. 
   
   
       14 . The medical device of  claim 12  wherein the porous hydrophobic polymer substrate composes a blood-contacting component of a medical device. 
   
   
       16 . The medical device of  claim 12  wherein the porous hydrophobic polymer substrate includes at least one polymer material selected from the group consisting of porous polyethylene materials, porous polypropylene materials, porous polyurethane materials, porous polyacrylate materials, porous polymethacrylate materials and porous fluoropolymer materials. 
   
   
       17 . The medical device of  claim 16  wherein the porous fluoropolymer material comprises an expanded poly(tetrafluoroethylene) material. 
   
   
       18 . The medical device of  claim 12  wherein the hemocompatible substance comprises ionic heparin and a hydrophobic counter ion. 
   
   
       19 . The medical device of  claim 18  wherein the hydrophobic counter ion is a hydrophobic quaternary ammonium ion. 
   
   
       20 . The medical device of  claim 18  wherein the hydrophobic counter ion is one or more of benzylalkonium ion and tridodecylmethylammonium ion. 
   
   
       21 . The medical device of  claim 12  wherein the hemocompatible substance is deposited on the hydrophobic polymer substrate by dipping. 
   
   
       22 . A medical device, comprising at least one blood-contacting surface comprising a porous hydrophobic polymer substrate, wherein at least a portion of the at least one blood-contacting surface comprises a hemocompatible polymer substrate produced by:
 a) providing a hemocompatible substance,   b) preparing a solution comprising a mixture of:
 a first solvent that wets the porous hydrophobic polymer substrate; 
 a second solvent that enhances the solubility of the hemocompatible substance in the solution; and 
 the hemocompatible substance; and, 
   c) contacting the surface of the porous hydrophobic polymer substrate with the solution thereby causing the hemocompatible substance to deposit onto the surface of the porous hydrophobic polymer substrate,   provided that the amount of a mixture of trichloro trifluoro ethanes is 10 wt % or less.   
   
   
       23 . The medical device of  claim 22  wherein the medical device is a stent. 
   
   
       24 . The medical device of  claim 22  wherein the porous hydrophobic polymer substrate composes a blood-contacting component of a medical device. 
   
   
       25 . The medical device of  claim 22  wherein the porous hydrophobic polymer substrate includes at least one polymer material selected from the group consisting of porous polyethylene materials, porous polypropylene materials, porous polyurethane materials, porous polyacrylate materials, porous polymethacrylate materials and porous fluoropolymer materials. 
   
   
       26 . The medical device of  claim 25  wherein the porous fluoropolymer material comprises an expanded poly(tetrafluoroethylene) material. 
   
   
       27 . The medical device of  claim 22  wherein the hemocompatible substance comprises ionic heparin and a hydrophobic counter ion. 
   
   
       28 . The medical device of  claim 27  wherein the hydrophobic counter ion is a hydrophobic quaternary ammonium ion. 
   
   
       29 . The medical device of  claim 27  wherein the hydrophobic counter ion is one or more of benzylalkonium ion and tridodecylmethylammonium ion. 
   
   
       30 . The medical device of  claim 22  wherein the hemocompatible substance is deposited on the hydrophobic polymer substrate by dipping. 
   
   
       31 . The medical device of  claim 30  wherein the second solvent particularly enhances solubility of the hemocompatible substance. 
   
   
       32 . A medical device, comprising at least one blood-contacting surface comprising a porous hydrophobic polymer substrate, wherein at least a portion of the at least one blood-contacting surface comprises a hemocompatible polymer substrate produced by:
 a) providing a hemocompatible substance,   b) preparing a solution comprising a mixture of:
 a first solvent that wets the porous hydrophobic polymer substrate; 
 a second solvent that enhances the solubility of the hemocompatible substance in the solution; and 
 the hemocompatible substance; and 
   c) contacting the surface of the porous hydrophobic polymer substrate with the solution thereby causing the hemocompatible substance to deposit onto the surface of the porous hydrophobic polymer substrate,   provided that the solution has a maximum ethanol content of 10 wt %.   
   
   
       33 . The medical device of  claim 32  wherein the medical device is a stent. 
   
   
       34 . The medical device of  claim 32  wherein the porous hydrophobic polymer substrate composes a blood-contacting component of a medical device. 
   
   
       35 . The medical device of  claim 32  wherein the porous hydrophobic polymer substrate includes at least one polymer material selected from the group consisting of porous polyethylene materials, porous polypropylene materials, porous polyurethane materials, porous polyacrylate materials, porous polymethacrylate materials and porous fluoropolymer materials. 
   
   
       36 . The medical device of  claim 35  wherein the porous fluoropolymer material comprises an expanded poly(tetrafluoroethylene) material. 
   
   
       37 . The medical device of  claim 32  wherein the hemocompatible substance comprises ionic heparin and a hydrophobic counter ion. 
   
   
       38 . The medical device of  claim 37  wherein the hydrophobic counter ion is a hydrophobic quaternary ammonium ion. 
   
   
       39 . The medical device of  claim 37  wherein the hydrophobic counter ion is one or more of benzylalkonium ion and tridodecylmethylammonium ion. 
   
   
       40 . The medical device of  claim 32  wherein the hemocompatible substance is deposited on the hydrophobic polymer substrate by dipping. 
   
   
       41 . The medical device of  claim 40  wherein the second solvent particularly enhances solubility of the hemocompatible substance.

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