Balloon and manufacture thereof

Claim 2

High molecular weight, biaxially oriented, flexible polymeric balloon, the tensile strength of the wall of said balloon being at least 218.66 MPa (31,714 psi).

Claim 3

Balloon of Claim 1 having a burst pressure of at least 1.4 MPa (200 psi).

Claim 4

High molecular weight, high tensile strength, biaxially oriented, flexible polymeric balloon having a burst pressure of at least 1.4 MPa (200 psi).

Claim 5

High molecular weight, high tensile strength, biaxially oriented, flexible polymeric balloon having a burst pressure of at least 1.4 MPa (200 psi).

Claim 6

Balloon of any one of Claims 1 to 3 wherein the polymer is a polyethylene terephthalate homopolyester having an intrinsic viscosity of 0.8 to 1.1.

Claim 7

Balloon of any one of Claims 1 to 4 having a wall thickness of 0.028 to 0.045 mm.

Claim 8

Dilatation balloon catheter comprising the balloon of any one of Claims 1 to 5.

Claim 9

Process for forming a high molecular weight, high tensile strength, biaxially oriented, flexible polymeric balloon according to Claim 1 or Claim 3, 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 (L₁), an internal diameter (ID) and an outer diameter (OD) to a length (L₂), and thereafter expanding the drawn tubing of internal diameter (ID₁) and outer diameter (OD₁) by expanding means to an internal diameter (ID₂) and an outer diameter (OD₂) whereby the ratio (ID₂)/(ID) is substantially greater than the ratio (OD₂)/(OD), followed by cooling the drawn and expanded tubing to less than its second order transition temperature.

Claim 10

Process of Claim 7 (when referred to Claim 1) wherein the balloon thus formed has a burst pressure of at least 1.4 MPa (200 psi).

Claim 11

Process of Claim 7 or Claim 8 wherein the expanding means is pressurized fluid applied to the inside of the tubing.

Claim 12

Process of Claim 9 wherein the pressurized fluid is a pressurized gas.

Claim 13

Process of any one of Claims 7 to 10 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.

Claim 14

Process of any one of Claims 7 to 11 wherein the tubing drawing temperature is different from the tubing expanding temperature.

Claim 15

Process of any one of Claims 7 to 12 wherein the ratio (ID₂)/(ID) to (OD₂)/(OD) is in the range 1.5 to 2.67.

Claim 16

Dilatation balloon catheter comprising the balloon produced by the process of any one of Claims 7 to 13.

Claim 17

High molecular weight, biaxially oriented, flexible polymeric balloon, the tensile strength of the wall of said balloon being at least 218.66 MPa (31,714 psi), obtainable by drawing and radially expanding high molecular weight biaxially orientable polymeric tubing of internal diameter (ID) and outer diameter (OD) to an internal diameter (ID₂) and outer diameter (OD₂) whereby the ratio (ID₂)/(ID) is substantially greater than the ratio (OD₂)/(OD).

Claim 18

High molecular weight, biaxially oriented, flexible polymeric balloon, the tensile strength of the wall of said balloon being at least 218.66 MPa (31,714 psi), obtainable by drawing and radially expanding high molecular weight biaxially orientable polymeric tubing of internal diameter (ID) and outer diameter (OD) to an internal diameter (ID₂) and outer diameter (OD₂) whereby the ratio (ID₂)/(ID) is substantially greater than the ratio (OD₂)/(OD).

Claim 19

High molecular weight, high tensile strength, biaxially oriented, flexible polymeric balloon having a burst pressure of at least 1.4 MPa (200 psi) obtainable by drawing and radially expanding high molecular weight biaxially orientable polymeric tubing of internal diameter (ID) and outer diameter (OD) to an internal diameter (ID₂) and outer diameter (OD₂) whereby the ratio (ID₂)/(ID) is substantially greater than the ratio (OD₂)/(OD).

Claim 20

High molecular weight, high tensile strength, biaxially oriented, flexible polymeric balloon having a burst pressure of at least 1.4 MPa (200 psi) obtainable by drawing and radially expanding high molecular weight biaxially orientable polymeric tubing of internal diameter (ID) and outer diameter (OD) to an internal diameter (ID₂) and outer diameter (OD₂) whereby the ratio (ID₂)/(ID) is substantially greater than the ratio (OD₂)/(OD).