Dual-layer medical balloon and process of making
A dual-layer dilatation balloon, and a process of making such balloon, which includes an inner layer that includes a plasticizer and a polymer selected from the group consisting of a polyamide, a copolymer thereof, and a combination thereof, and an outer layer that includes an ethylene-propylene rubber. The dual-layer balloon optionally further includes a stent disposed on the balloon. The stent is optionally a drug-eluting stent.
1. A dual-layer dilatation balloon comprising:
an inner layer comprising a plasticizer and a polymer selected from the group consisting of a polyamide, a copolymer thereof, and a combination thereof;
an outer layer comprising a maleated ethylene-propylene rubber and a drug or biologically active material;
wherein the maleated ethylene-propylene rubber reduces and/or prevents migration of the plasticizer out of the inner layer to thereby reduce and/or prevent contact between the plasticizer and the drug or biologically active material.
2. The balloon of claim 1 , wherein said inner layer comprises a nylon polymer.
3. The balloon of claim 2 , wherein the nylon polymer comprises nylon-3, nylon-6, nylon-11, nylon-12, nylon-1/6, nylon-4/6, nylon-6/6, or nylon-6/10.
4. The balloon of claim 1 , wherein the copolymer of a polyamide comprises a polyether block amide.
5. The balloon of claim 1 , wherein the balloon has a hoop strength of 10,000 psi to 60,000 psi.
6. The balloon of claim 1 , wherein the outer layer comprises a maleated ethylene-propylene-diene rubber.
7. The balloon of claim 1 , wherein the plasticizer comprises a carbonamide, sulfonamide, phenolic compound, cyclic ketone, mixture of phenols and esters, sulfonated ester, sulfonated amide, N-alkylarylsulfonamide, aliphatic diol, phosphite ester of an alcohol, phthalate ester, alcohol, ether, amine, or combinations thereof.
8. The balloon of claim 1 , wherein one or both of said inner and outer layers further comprise at least one of a filler, antioxidant, colorant, crosslinking agent, impact strength modifier, or combinations thereof.
9. The balloon of claim 1 , further comprising a stent disposed on said balloon.
10. The balloon of claim 9 , wherein the stent is a drug-eluting stent comprising a drug or biologically active material.
11. A balloon dilatation catheter, comprising:
a tubular elongated catheter shaft having proximal and distal portions; and
a dual-layer dilatation balloon disposed on said shaft, wherein the balloon comprises:
an inner layer comprising a plasticizer and a polymer selected from the group consisting of a polyamide, a copolymer thereof, and a combination thereof;
an outer layer comprising a maleated ethylene-propylene rubber and a drug or biologically active material;
wherein the maleated ethylene-propylene rubber reduces and/or prevents migration of the plasticizer out of the inner layer to thereby reduce and/or prevent contact between the plasticizer and the drug or biologically active material.
12. The catheter of claim 11 , further comprising a stent disposed on the balloon.
13. The catheter of claim 12 , wherein the stent is a drug-eluting stent comprising a drug or biologically active material.
14. The catheter of claim 11 , wherein the inner layer comprises a nylon polymer.
15. The catheter of claim 14 , wherein the nylon polymer is nylon-3, nylon-6, nylon-11, nylon-12, nylon-1/6, nylon-4/6, nylon-6/6, or nylon-6/10.
16. The catheter of claim 11 , wherein the copolymer of a polyamide comprises a polyether block amide.
17. The catheter of claim 11 , wherein the balloon has a hoop strength of 10,000 psi to 60,000 psi.
18. The catheter of claim 11 , wherein the outer layer comprises a maleated ethylene-propylene-diene rubber.
19. A process for forming a dual-layer dilatation balloon, comprising:
forming a dual-layer extrudate comprising:
an inner layer comprising a plasticizer and a polymer selected from the group consisting of a polyamide, a copolymer thereof, and a combination thereof; and
an outer layer comprising a maleated ethylene-propylene rubber; and
forming a dual-layer balloon from the dual-layer extrudate in a balloon forming machine;
adding a drug or biologically active material to the outer layer of the balloon;
wherein the balloon has a hoop strength of 10,000 psi to 60,000 psi; and
wherein the maleated ethylene-propylene rubber reduces and/or prevents migration of the plasticizer out of the inner layer to thereby reduce and/or prevent contact between the plasticizer and the drug or biologically active material.
20. The process of claim 19 , wherein the copolymer of a polyamide comprises a polyether block amide.
21. The process of claim 19 , wherein the outer layer comprises a maleated ethylene-propylene-diene rubber.
22. A balloon dilatation catheter, comprising:
a tubular elongated catheter shaft having proximal and distal portions; and
a dual-layer dilatation balloon disposed on said shaft, wherein the balloon comprises:
an inner layer comprising a plasticizer and a polymer selected from the group consisting of a polyamide, a copolymer thereof, and a combination thereof;
an outer layer comprising a maleated ethylene-propylene rubber; and
a drug-eluting stent disposed on said balloon, wherein said drug-eluting stent comprises a drug or biologically active material;
wherein the outer layer reduces and/or prevents migration of the plasticizer out of the inner layer to thereby reduce and/or prevent contact between the plasticizer and the drug or biologically active material.