Balloon and manufacture thereof

Claim 2

High molecular weight, biaxially oriented, flexible polymeric balloon having a burst pressure of at least 200 psi (1.4 MPa) and a radial expansion of less than 5% at 200 psi (1.4 MPa).

Claim 3

Balloon of claim 1 having a burst pressure of at least 400 psi (2.8 MPa) and a radial expansion of less than 10% at 400 psi (2.8 MPa).

Claim 4

Balloon of claim 1 having a burst pressure of at least 500 psi (3.4 MPa) and a radial expansion of less than 10% at 500 psi (3.4 MPa).

Claim 5

Balloon of claim 3 wherein the polymer is a polyethylene terephthalate homopolyester having an intrinsic viscosity of 0.8 to 1.1.

Claim 6

Process for forming a high molecular weight, biaxially oriented, flexible polymeric balloon, the process comprising, at a temperature within the range extending from the second order transition temperature to the first order transition temperature, drawing a polymeric tubing having a finite length (L 1 ) and an internal diameter (ID) which is about one-half the outer diameter (OD) to a length (L 2 ) which is 3 to 6 L 1 , and thereafter expanding the drawn tubing of internal diameter ID 1 and outer diameter OD 1 by expanding means to an internal diameter (ID 2 ) which is 6 to 8 ID and an outer diameter (OD 2 ) which is about 3 to 4 OD, following by cooling the drawn and expanded tubing to less than its second order transition temperature, said balloon thus formed having a burst pressure of at least 200 psi (1.4 MPa) and a radial expansion beyond nominal inflated diameter of less than 5% at 200 psi (1.4 MPa).

Claim 7

Process for forming a high molecular weight, biaxially oriented, flexible polymeric balloon, the process comprising, at a temperature within the range extending from the second order transition temperature to the first order transition temperature, drawing a polymeric tubing having a finite length (L 1 ) and an internal diameter (ID) which is about one-half the outer diameter (OD) to a length (L 2 ) which is 3 to 6 L 1 , and thereafter expanding the drawn tubing of internal diameter ID 1 and outer diameter OD 1 by expanding means to an internal diameter (ID 2 ) which is 6 to 8 ID and an outer diameter (OD 2 ) which is about 3 to 4 OD, following by cooling the drawn and expanded tubing to less than its second order transition temperature, said balloon thus formed having a burst pressure of at least 200 psi (1.4 MPa) and a radial expansion beyond nominal inflated diameter of less than 5% at 200 psi (1.4 MPa).

Claim 8

Process of claim 5 wherein the expanding means is pressurized fluid applied to the inside of the tubing.

Claim 9

Process of claim 6 wherein the pressurized fluid is a pressurized gas.

Claim 10

Process of claim 5 wherein the tubing is formed by extrusion of polyethylene terephthalate homopolyester resin having an intrinsic viscosity of 1.0 to 1.3 and a density of 1.35 to 1.45 and the balloon has a burst pressure of at least 400 psi (2.8 MPa).

Claim 11

Process of claim 8 wherein the temperature is in the range 84°-99° C.

Claim 12

Process of claim 8 wherein the temperature is in the range 86°-96° C.

Claim 13

Process of claim 8 wherein the tubing drawing temperature is different from the tubing expanding temperature.

Claim 14

Dilatation balloon catheter comprising the balloon of claim 1. .Iadd.

Claim 15

Process for forming a high molecular weight, biaxially oriented, flexible polymeric balloon having a wall tensile strength of at least 31,714 psi (218.86 MPA), the process comprising, at a temperature within the range extending from the second order transition temperature to the first order transition temperature, drawing a polymeric tubing having a finite length (L 1 ) and an internal diameter (ID) to a length (L 2 ) which is 3 to 6 L 1 , and thereafter expanding the drawn tubing of internal diameter (ID 1 ) and outer diameter (OD 1 ) by expanding means to an internal diameter (ID 2 ) which is 6 to 8 ID, followed by cooling the drawn and expanded tubing to less than its second order transition temperature. .Iaddend. .Iadd.

Claim 16

Process for forming a high molecular weight, biaxially oriented, flexible polymeric balloon having a wall tensile strength of at least 31,714 psi (218.86 MPA), the process comprising, at a temperature within the range extending from the second order transition temperature to the first order transition temperature, drawing a polymeric tubing having a finite length (L 1 ) and an internal diameter (ID) to a length (L 2 ) which is 3 to 6 L 1 , and thereafter expanding the drawn tubing of internal diameter (ID 1 ) and outer diameter (OD 1 ) by expanding means to an internal diameter (ID 2 ) which is 6 to 8 ID, followed by cooling the drawn and expanded tubing to less than its second order transition temperature. .Iaddend. .Iadd.

Claim 17

Process of claim 13 wherein the balloon thus formed has a burst pressure of at least 200 psi (1.4 MPa). .Iaddend. .Iadd.15. Process of claim 13 wherein the expanding means is pressurized fluid applied to the inside of the tubing. .Iaddend. .Iadd.16. Process of claim 15 wherein the pressurized fluid is a pressurized gas. .Iaddend. .Iadd.17. Process of claim 13 wherein the polymeric tubing is formed by extrusion of polyethylene terephthalate homopolyester resin having an intrinsic viscosity of 1.0 to 1.3 and a density of 1.35 to 1.45. .Iaddend. .Iadd.18. Process of claim 13 wherein the tubing drawing temperature is different from the tubing expanding temperature. .Iaddend. .Iadd.19. Balloon produced by the process of claim 13. .Iaddend.