Medical devices employing chain extended polymers
View Patent ↗Medical devices such as catheters and balloons are formed from a thermoplastic polymer composition comprising a melt mixture product of at least one terminally reactive polymer and a chain extender.
1. A method of preparing a medical device balloon comprising
preparing a polymer composition in melt form, and then
extruding the polymer composition to form tubing and
blowing a segment of the tubing to form the balloon,
without remelting the composition, wherein the step of preparing the polymer composition in melt form comprises
forming a melted reaction mixture comprising
a) at least one terminally reactive polymer and
b) a chain extender and
reacting the reaction mixture.
2. A method as in claim 1 wherein the terminally reactive polymer has at least one terminal active hydrogen and/or carboxylic acid group thereon.
3. A method as in claim 1 wherein the terminally reactive polymer is selected from the group consisting of polyesters; polyamides; polyurethanes; block copolymers incorporating a polyester, polyamide, polyurethane and/or polyether segment.
4. A method as in claim 3 wherein the polymer composition further comprises a polymer selected from the group consisting of polyolefins, poly(meth)acrylate esters, silicones, and organic rubbers.
5. A method as in claim 1 wherein the chain extender comprises a bis-lactam compound.
6. A method as in claim 5 wherein the bis-lactam compound is employed in said reaction mixture in an amount of from about 0.1% to about 5% by weight of the terminally reactive polymer.
7. A method as in claim 5 wherein the bis-lactam compound is a member selected from the group consisting of N,N′-isophthaloyl bis-caprolactam, N,N′-adipoyl bis-caprolactam, N,N′-terephthaloyl bis-laurolactam, N,N′-isophthaloyl bis-butyrolactam, carbonyl bis-caprolactam and mixtures thereof.
8. A method as in claim 1 wherein the chain extender comprises a bis-oxazoline and/or bis-oxazine compound.
9. A method as in claim 8 wherein the bisoxazoline and/or bisoxazine compound is a member selected from the group consisting of 2,2′-bis(2-oxazoline), 2,2-bis(4-methyl-2-oxazoline), 2,2′-bis(4-phenyl-2-oxazoline), 2,2′-bis(4-hexyloxazoline), 2,2′-p-phenylene bis(2-oxazoline), 2,2′-m-phenylene bis(2-oxazoline), 2,2′-tetramethylene bis(4,4′-dimethyl-2-oxazoline) 2,2′-bis(2-oxazine), 2,2-bis(4-methyl-2-oxazine), 2,2′-bis(4-phenyl-2-oxazine), 2,2′-bis(4-hexyloxazine), 2,2′-p-phenylene bis(2-oxazine), 2,2′m-phenylene bis(2-oxazine), 2,2-tetramethylene bis(4,4′-dimethyl-2-oxazine) and mixtures thereof.
10. A method as in claim 8 wherein the bis-oxazoline and/or bis-oxazine compound is employed in said reaction mixture in an amount of from about 0.1% to about 4% by weight of the terminally reactive polymer.
11. A method as in claim 1 wherein the chain extender is incorporated into said reaction mixture in an amount which increases polymer molecular weight but does not substantially promote or induce crosslinking.
12. A method of preparing a medical device comprising
preparing a polymer composition in melt form, and then
forming at least a portion of the device from the polymer composition
without remelting the composition, wherein the step of preparing the polymer composition in melt form comprises
forming a melted reaction mixture comprising
a) at least one terminally reactive thermoplastic polymer, and
b) a chain extender and
reacting the reaction mixture.
13. A method as in claim 12 wherein the terminally reactive polymer has at least one active hydrogen and/or carboxylic acid group thereon.
14. A method as in claim 12 wherein said step of forming at least a portion of the device from a thermoplastic polymer composition comprises extruding a tube of said polymer composition.
15. A method as in claim 14 wherein the medical device is a catheter or a balloom.
16. A method as in claim 12 wherein the medical device is a balloon, the method further comprising blowing a segment of the extruded tube at an elevated temperature and pressure to form the balloom.
17. A method as in claim 12 wherein the chain extender is incorporated into said reaction mixture in an amount which increases polymer molecular weight but does not substantially promote or induce crosslinking.
18. A method as in claim 14 wherein said tubing is extruded from an extruder and said reaction mixture is prepared in the extruder.
19. A method claim 1 wherein said tubing is extruded from an extruder and said reaction mixture is prepared in the extruder.