Medical device and plasticized nylon

1. A medical device comprising a plasticized nylon which forms at least a portion of the medical device, wherein the medical device is a balloon, wherein the plasticized nylon comprises a nylon and 0.1 wt-% to 50 wt-% of an amide-containing plasticizer, based on the total weight of the plasticized nylon, wherein the plasticizer is mixed within the nylon and has the following structure:

wherein:

each R 1 , R 3 , and R 5 is independently selected from a C2-C18 linear, branched, or cyclic alkyl group, a C5-C12 monovalent aromatic group, and combinations thereof; and

each R 2 and R 4 is independently selected from a C1-C5 linear alkylene group, a C5-C12 divalent aromatic group, and combinations thereof.

2. The medical device of claim 1 wherein each R 1 , R 3 , and R 5 is independently selected from a C6-C12 linear, branched, or cyclic alkyl group.

3. The medical device of claim 1 wherein each R 2 and R 4 is independently selected from a C2-C4 linear, branched, or cyclic alkylene group.

4. The medical device of claim 1 wherein the amide-containing plasticizer is prepared from an amine and a fatty acid in a stoichiometric amount.

5. The medical device of claim 1 which is a dilatation balloon.

6. The medical device of claim 5 wherein the nylon is selected from the group of nylon-6, nylon-7, nylon-8, nylon-9, nylon-10, nylon-11, nylon-12, nylon-13, nylon-14, nylon-15, nylon-16, nylon-17, nylon-18, nylon-6,6, nylon-6,8, nylon-6,10, nylon-6,12, nylon-6,14, nylon-8,8, nylon-8,10, nylon-8,12, nylon-8,14, nylon-10,10, nylon-10,12, nylon-8,12, nylon-10,14, nylon-12,12, nylon-12,14, nylon-14,16, and combinations thereof.

7. The medical device of claim 6 wherein the nylon is selected from the group of nylon-10, nylon-11, nylon-12, nylon-10,10, nylon-10,12, and combinations thereof.

8. The medical device of claim 5 wherein the amide-containing plasticizer is selected to decrease the flexural modulus and/or tensile modulus of the nylon and is used in an amount of 3.5 wt-% to 50 wt-%, based on the total weight of the plasticized nylon.

9. The medical device of claim 8 wherein the nylon is selected from the group of nylon-6, nylon-7, nylon-8, nylon-9, nylon-10, nylon-11, nylon-12, nylon-13, nylon-14, nylon-15, nylon-16, nylon-17, nylon-18, nylon-6,6, nylon-6,8, nylon-6,10, nylon-6,12, nylon-6,14, nylon-8,8, nylon-8,10, nylon-8,12, nylon-8,14, nylon-10,10, nylon-10,12, nylon-8,12, nylon-10,14, nylon-12,12, nylon-12,14, nylon-14,16, and combinations thereof.

10. The medical device of claim 9 wherein the nylon is selected from the group of nylon-10, nylon-11, nylon-12, nylon-10,10, nylon-10,12, and combinations thereof.

11. The medical device of claim 1 wherein the nylon is selected from the group of nylon-6, nylon-7, nylon-8, nylon-9, nylon-10, nylon-11, nylon-12, nylon-13, nylon-14, nylon-15, nylon-16, nylon-17, nylon-18, nylon-6,6, nylon-6,8, nylon-6,10, nylon-6,12, nylon-6,14, nylon-8,8, nylon-8,10, nylon-8,12, nylon-8,14, nylon-10,10, nylon-10,12, nylon-8,12, nylon-10,14, nylon-12,12, nylon-12,14, nylon-14,16, and combinations thereof.

12. The medical device of claim 11 wherein the nylon is selected from the group of nylon-10, nylon-11, nylon-12, nylon-10,10, nylon-10,12, and combinations thereof.

13. The medical device of claim 1 wherein the amide-containing plasticizer is selected to decrease the flexural modulus and/or tensile modulus of the nylon and is used in an amount of 1 wt-% to 50 wt-%, based on the total weight of the plasticized nylon.

14. A dilatation balloon comprising a plasticized nylon which forms at least a portion of the dilatation balloon, wherein the plasticized nylon comprises nylon-12 and 0.1 wt-% to 50 wt-% of an amide-containing plasticizer, based on the total weight of the plasticized nylon, wherein the amide-containing plasticizer is mixed within the nylon-12 and has the following structural formula:

wherein:

each R 1 , R 3 , and R 5 is independently selected from a C2-C18 linear, branched, or cyclic alkyl group, a C5-C12 monovalent aromatic group, and combinations thereof; and

each R 2 and R 4 is independently selected from a C1-C5 linear alkylene group, a C5-C12 divalent aromatic group, and combinations thereof.

15. A balloon dilatation catheter, comprising:

a tubular elongated catheter shaft having proximal and distal portions; and

a dilatation balloon disposed on said shaft, wherein the shaft and/or balloon comprises a plasticized nylon, wherein the plasticized nylon comprises Nylon-12 and 0.1 wt-% to 50 wt-% of an amide-containing plasticizer, based on the total weight of the plasticized nylon, wherein the amide-containing plasticizer is mixed within the Nylon-12 and has the following structural formula:

wherein:

each R 1 , R 3 , and R 5 is independently selected from a C2-C18 linear, branched, or cyclic alkyl group, a C5-C12 monovalent aromatic group, and combinations thereof; and

each R 2 and R 4 is independently selected from a C1-C5 linear alkylene group, a C5-C12 divalent aromatic group, and combinations thereof.

16. The catheter of claim 15 further comprising a stent disposed on the balloon.

17. The dilatation balloon of claim 14 wherein the amide-containing plasticizer is selected and used in an amount that decreases the flexural modulus and/or tensile modulus of the nylon-12.

18. The dilatation balloon of claim 17 wherein the amide-containing plasticizer is selected and used in an amount that decreases the flexural modulus and/or tensile modulus of the nylon-12 while maintaining the tensile strength of the nylon.

19. A medical device comprising a plasticized nylon which forms at least a portion of the medical device, wherein the medical device is a balloon, wherein the plasticized nylon comprises a nylon and 0.1 wt-% to 50 wt-% of an amide-containing plasticizer, based on the total weight of the plasticized nylon, wherein the plasticizer is mixed within the nylon and has the following structure:

wherein:

each R 1 , R 3 , and R 5 is independently selected from a C7-C8 linear, branched, or cyclic alkyl group; and

each R 2 and R 4 is independently selected from a C1-C5 linear alkylene group, a C5-C12 divalent aromatic group, and combinations thereof.