Angioplasty medical devices made of elastomeric material
The present invention relates to a medical device for angioplasty or parts thereof, which is made of elastomeric material, wherein the elastomeric material comprises a polyamide-based polymer obtained from the polymerization of a compound forming polyamide blocks that is selected from the group consisting of an aminocarboxylic acid of Formula (1) and a lactam of Formula (2): with a polyether diamine triblock compound of Formula (3): and a dicarboxylic acid of Formula (4): HOOC—(R3) m -COOH (4) wherein the groups R1, R2 and R3 are each binding groups comprising a hydrocarbon chain therein that may be interrupted by one or more amide groups; x is an integer from 1 to 20; y is an integer from 4 to 50, z is an integer from 1 to 20; m is 0 or 1.
1. An angioplasty balloon comprising a polymer mixture comprising a polyamide and from 10 to 90% by weight of an elastomeric material, characterized in that said elastomeric material comprises a polyamide-based polymer obtained from the polymerization of a compound forming polyamide blocks that is selected from the group consisting of an aminocarboxylic acid of Formula (1) and a lactam of Formula (2):
with a polyether diamine triblock compound of Formula (3):
and a dicarboxylic acid of Formula (4):
HOOC—(R3) m -COOH (4)
wherein the groups R1, R2 and R3 are each binding groups comprising a hydrocarbon chain therein that may be interrupted by one or more amide groups; x is an integer from 1 to 20; y is an integer from 4 to 50, z is an integer from 1 to 20; m is 0 or 1;
wherein the angioplasty balloon is provided on a catheter, and wherein the angioplasty balloon is configured for inflation and deflation during an angioplasty operation.
2. The angioplasty balloon according to claim 1 , wherein R1 and R2 independently comprise an alkylene group having 2 to 20 carbon atoms and amide bonds, R3 comprises an alkylene group having 1 to 20 carbon atoms, x is an integer from 1 to 18, y is an integer from 4 to 50, and z is an integer from 1 to 20.
3. The angioplasty balloon according to claim 1 , wherein x, y and z are 3, 14, 2, respectively.
4. The angioplasty balloon according to claim 1 , wherein said aminocarboxylic acid of Formula (1) and said lactam of Formula (2) are independently aliphatic, alicyclic or aromatic.
5. The angioplasty balloon according to claim 1 , wherein said dicarboxylic acid (4) include dicarboxylic acids having 2 to 20 carbon atoms.
6. The angioplasty balloon according to claim 1 , wherein said dicarboxylic acid (4) is synthesized by dimerization of unsaturated fatty acids.
7. The angioplasty balloon according to claim 1 , wherein said lactams (2) include compounds having 5 to 20 carbon atoms.
8. The angioplasty balloon according to claim 1 , wherein said amino-carboxylic acids (1) include aliphatic w-aminocarboxylic acids having 5 to 20 carbon atoms.
9. The angioplasty balloon according to claim 1 , wherein the polyamide segment is selected from PA 6, PA 6/6, PA 6/9, PA 6/10, PA 6/12, PA 6/36, PA 11, PA 12 and PA 12/12, or is obtained from C 2 -C 36 dicarboxylic acids and C 2 -C 12 diamines, from monomers of C 6 -C 12 lactams or monomers of C 6 -C 12 aminocarboxylic acids.
10. The angioplasty balloon according to claim 1 , wherein said polyamide-based polymer is represented by Formula (5):
HO—(OC-PA-CO—HN-Pe-NH) n —H (5)
wherein PA is the polyamide portion and Pe is a polyether portion, whereas n is the number of units forming the polymer.
11. The angioplasty balloon according to claim 10 , wherein the molecular weight of said polyamide-based polymer ranges between 19000 and 50000.
12. The angioplasty balloon according to claim 1 , wherein x is an integer from 2 to 6, y is an integer from 6 to 12, and z is an integer from 1 to 5.
13. The angioplasty balloon according to claim 1 , wherein said polymerization is carried out using 15 to 70 wt % of said compound of Formula (1) and/or (2) and a mixture of said compounds of Formula (3) and (4), with total weight ranging from 30 to 85%.
14. The angioplasty balloon according to claim 13 , wherein said polymerization is carried out by mixing said compounds of Formula (1) and/or (2), said compound of Formula (3) and said compound of Formula (4), by heating at a temperature ranging between 150 and 300° C.
15. The angioplasty balloon according to claim 13 , wherein said polymerization is carried out by pre-polymerizing said compounds of formula (1) and/or (2) with said compound of Formula (4) and subsequently adding said compound of Formula (3) to the pre-polymer thus obtained, until the polymerization is completed.
16. The angioplasty balloon according to claim 1 , wherein the dicarboxylic acid of Formula (4) is an aliphatic dicarboxylic acid.
17. The angioplasty balloon according to claim 1 , wherein said polyamide-based elastomer is comprised in said elastomeric material in an amount from 75 to 25% by weight, the remaining part being polyamide.
18. The angioplasty balloon according to claim 17 , wherein said polyamide-based elastomer is comprised in said elastomeric material in an amount from 60 to 40% by weight, the remaining part being polyamide.
19. The angioplasty balloon according to claim 1 , wherein said polymer mixture comprising said polyamide and said elastomeric material is in multi-layer form.
20. The angioplasty balloon according to claim 1 , wherein said polyamide is polyamide 12.
21. The angioplasty balloon according to claim 1 , wherein said balloon has a diameter of 1.50 mm, a double average wall thickness lower than 0.023 mm.
22. The angioplasty balloon according to claim 1 , wherein said balloon has a maximum flexural load lower than 0.040 N.
23. The angioplasty balloon according to claim 1 , wherein said balloon has, at 2 mm diameter, an average burst pressure higher than 23 bar, and a calculated RBP higher than 20 bar.
24. The angioplasty balloon according to claim 19 , wherein said balloon has a tensile strength at break higher than 5 N.
25. The angioplasty balloon according to claim 19 , wherein said balloon has a percentage elongation at break higher than 30%.