Biocompatible self-lubricating polymer compositions and their use in medical and surgical devices

Abstract

The invention comprises self-lubricating polymer compositions that are especially useful in medical devices and valves and gaskets of medical devices. In a preferred embodiment, the polymer compositions comprise a thermosetting or thermoplastic silicone elastomer in combination with a lubricity enhancing polyfluoropolyether fluid or hydrocarbon-based synthetic oil. In other preferred embodiments, the polymer compositions contain only biocompatible components. The improved anti-friction properties of the self-lubricating polymers can be demonstrated over a course of insertion and withdrawal cycles, where conventional polymers have changing and mostly increasing force required for each insertion and withdrawal, while the polymer compositions of the invention remain stable.

1 . A biocompatible, self-lubricating polymer composition comprising a silicone elastomer and about 1 to about 20 parts per hundred by weight (phr) of a lubricity enhancing PFPE or hydrocarbon based synthetic oils. 
   
   
       2 . The self-lubricating polymer composition of  claim 1 , wherein the silicone elastomer is selected from one or more silicone resins having a durometer hardness from about 10 to about 90 on the Shore A scale. 
   
   
       3 . The self-lubricating polymer composition of  claim 1 , wherein the PFPE synthetic oil is present at about 4 to about 20 phr. 
   
   
       4 . The self-lubricating polymer composition of  claim 2 , wherein the PFPE synthetic oil is present at about 4 to about 20 phr. 
   
   
       5 . The self-lubricating polymer composition of  claim 1 , wherein the PFPE synthetic oil is present at about 4 to about 6 phr. 
   
   
       6 . The self-lubricating polymer composition of  claim 2 , wherein the PFPE synthetic oil is present at about 4 to about 6 phr. 
   
   
       7 . The self-lubricating polymer composition of  claim 1 , further comprising a biocompatible, solid lubricant micropowder. 
   
   
       8 . The self-lubricating polymer composition of  claim 1 , wherein the silicone elastomer is a methylvinyl silicone elastomer and has a durometer hardness of about 30 to about 40 in the Shore A scale. 
   
   
       9 . The self-lubricating polymer composition of  claim 8 , wherein the PFPE synthetic oil is present at about 4 to about 6 phr. 
   
   
       10 . The self-lubricating polymer composition of  claim 8 , further comprising a biocompatible, solid lubricant micropowder. 
   
   
       11 . A medical or surgical device having a receiving area for inserting or withdrawing, the receiving area having a seal comprising a self-lubricating polymer composition, the polymer composition comprising a silicone elastomer and one or more of a biocompatible solid lubricant at about 0.1 to 20 phr and a biocompatible liquid lubricant at about 0.1 to 20 phr. 
   
   
       12 . The medical or surgical device of  claim 11 , wherein the silicone elastomer has a durometer hardness from about 10 to about 90 on the Shore A scale. 
   
   
       13 . The medical or surgical device of  claim 12 , wherein the silicone elastomer is a methylvinyl silicone elastomer and has durometer hardness from about 20 to about 40 on the Shore A scale. 
   
   
       14 . The medical or surgical device of  claim 11 , wherein the polymer composition comprises PFPE synthetic oil. 
   
   
       15 . The medical or surgical device of  claim 14 , wherein the PFPE synthetic oil is present at about 4 to about 10 phr. 
   
   
       16 . The medical or surgical device of  claim 14 , wherein the PFPE synthetic oil is present at about 4 to about 6 phr. 
   
   
       17 . The medical or surgical device of  claim 15 , wherein the polymer composition contains no solid lubricant. 
   
   
       18 . The medical or surgical device of  claim 16 , wherein the polymer composition contains no solid lubricant. 
   
   
       19 . The medical or surgical device of  claim 11 , wherein the polymer composition comprises a solid lubricant micropowder at about 0.1 to 20 phr. 
   
   
       20 . A gasket or seal for a biomedical device comprising a self-lubricating polymer composition comprising a silicone elastomer and about 1 to about 20 parts per hundred by weight (phr) of a lubricity enhancing polyfluoropolyether fluid or hydrocarbon-based synthetic oil. 
   
   
       21 . The gasket or seal of  claim 20 , wherein the silicone elastomer is selected from one or more silicone resins having a durometer hardness from about 10 to about 90 on the Shore A scale. 
   
   
       22 . The gasket or seal of  claim 20 , wherein the silicone elastomer is a methylvinyl silicone elastomer and has a durometer hardness of about 20 to about 40 in the Shore A scale. 
   
   
       23 . The gasket or seal of  claim 20 , wherein the lubricity enhancing oil comprises PFPE synthetic oil and where PFPE is present at about 4 to about 10 phr. 
   
   
       24 . The gasket or seal of  claim 22 , wherein the lubricity enhancing oil comprises PFPE synthetic oil and where PFPE is present at about 4 to about 10 phr. 
   
   
       25 . The gasket or seal of  claim 20 , wherein the lubricity enhancing oil comprises PFPE synthetic oil and where PFPE is present at about 4 to about 10 phr. 
   
   
       26 . The gasket or seal of  claim 22 , wherein the lubricity enhancing oil comprises PFPE synthetic oil and where PFPE is present at about 4 to about 10 phr. 
   
   
       27 . The gasket or seal of  claim 20 , further comprising a biocompatible, solid lubricant micropowder. 
   
   
       28 . The gasket or seal of  claim 22 , further comprising a biocompatible, solid lubricant micropowder. 
   
   
       29 . A method of producing a biocompatible self-lubricating polymer for use in a medical or surgical device, comprising mixing a silicone elastomer or silicone elastomer blend having a durometer hardness of about 10 to about 90 on the Shore A scale with one or more liquid lubricants having a surface energy of about 10 to about 20 dyne/cm, and setting the mixture into a desired shape or mold for a selected medical or surgical device of part thereof. 
   
   
       30 . The method of  claim 29 , wherein the liquid lubricant is PFPE synthetic oil and PFPE is present at about 4 to about 10 phr. 
   
   
       31 . The method of  claim 29 , wherein the liquid lubricant is PFPE synthetic oil and PFPE is present at about 4 to about 6 phr. 
   
   
       32 . The method of  claim 29 , wherein the silicone elastomer is a methylvinyl silicone elastomer and has a durometer hardness of about 30 to about 40 on the Shore A scale. 
   
   
       33 . The method of  claim 29 , wherein the medical or surgical device is a tube having an outside diameter from about 5 mm to about 2 mm and an inside diameter of about 3.5 mm to about 1.5 mm. 
   
   
       34 . The method of  claim 29 , wherein the medical or surgical device is an introducer. 
   
   
       35 . The method of  claim 29 , wherein the medical or surgical device is a hemostasis valve. 
   
   
       36 . The method of  claim 29 , further comprising adding a biocompatible, solid lubricant micropowder to the mixture of silicone elastomer or blend and one or more liquid lubricants. 
   
   
       37 . The method of  claim 29 , wherein the polymer is used in the production of a receiving area for medical or surgical device or part thereof. 
   
   
       38 . The method of  claim 26 , wherein the receiving area for medical or surgical device or part thereof is formed into a dynamic seal. 
   
   
       39 . The method of  claim 29 , wherein the receiving area for medical or surgical device or part thereof is formed into a semidynamic seal. 
   
   
       40 . The method of  claim 29 , wherein the medical or surgical device is a catheter. 
   
   
       41 . The method of  claim 29 , wherein the polymer is used in the production of a sheath, tube or tubing, whereby the tube, sheath or tubing comprises at least about 10% or more of the self-lubricating polymer over its insertion length or receiving length. 
   
   
       42 . A medical or surgical device made from the method of  claim 37 . 
   
   
       43 . A medical or surgical device incorporating a sheath, tube or tubing made from the method of  claim 41 . 
   
   
       44 . A biocompatible self-lubricating polymer composition comprising a silicone elastomer and about 1 to about 20 phr of a biocompatible lubricant composition comprising one or more of a polyfluoropolyether synthetic oil, a polytetrafluoroethylene synthetic oil, a hydrocarbon-based synthetic oil, a low molecular weight polytetrafluoroethylene powder, a titanium dioxide micropowder, a molybdenum disulfide micropowder, a graphite micropowder, a baron nitride micropowder, or a porous micropowder. 
   
   
       45 . The self-lubricating polymer composition of  claim 44 , wherein the silicone elastomer is selected from one or more silicone resins having a durometer hardness from about 10 to about 90 on the Shore A scale. 
   
   
       46 . The self-lubricating polymer composition of  claim 44 , wherein the lubricant composition comprises PFPE synthetic oil. 
   
   
       47 . The self-lubricating polymer composition of  claim 46 , wherein PFPE is present at about 4 to about 10 phr. 
   
   
       48 . The self-lubricating polymer composition of  claim 47 , wherein the PFPE synthetic oil is present at about 4 to about 6 phr. 
   
   
       49 . The self-lubricating polymer composition of  claim 44 , wherein the lubricant composition consists essentially of PFPE synthetic oil. 
   
   
       50 . The self-lubricating polymer composition of  claim 49 , wherein the PFPE synthetic oil is present at about 1 to about 10 phr. 
   
   
       51 . The self-lubricating polymer composition of  claim 50 , wherein the PFPE is present at about 4 to 10 phr. 
   
   
       52 . The self-lubricating polymer composition of  claim 44 , wherein the silicone elastomer is a thermosetting or thermoplastic silicone elastomer. 
   
   
       53 . The self-lubricating polymer composition of  claim 52 , wherein the silicone elastomer is a methylvinyl silicone elastomer. 
   
   
       54 . The self-lubricating polymer composition of  claim 46 , wherein the silicone elastomer is a methylvinyl silicone elastomer. 
   
   
       55 . The self-lubricating polymer composition of  claim 49 , wherein the silicone elastomer is a methylvinyl silicone elastomer. 
   
   
       56 . The self-lubricating polymer composition of  claim 50 , wherein the silicone elastomer is a methylvinyl silicone elastomer.