MEDICAL DEVICE BALLOONS WITH IMPROVED STRENGTH PROPERTIES AND PROCESSES FOR PRODUCING SAME

摘要

A tubular parison for forming a medical device balloon. The parison is formed of a polymeric material, for instance a thermoplastic elastomer. The parison has an elongation at break which is not more than 80% of the elongation of the bulk polymeric material. The elongation of the parison is controlled by altering extrusion conditions. Balloons prepared from the parisons provide higher wall strength and/or higher inflation durability than balloons prepared from conventional parisons of the same material.

主权项

1. An expandable medical balloon, the expandable medical balloon comprising:
a balloon wall comprising thermoplastic elastomer, the balloon having a calculated burst strength of 32,000 psi or greater in a pre-sterilized condition as defined by the following equation:
Strength=(P×D/2t)×1000where P=internal pressure when the balloon bursts (kg/cm2 (1 kg/cm2=14.2 psi); D is the exterior diameter (mm) of the balloon when a burst pressure of 1 kg/cm2 (14.2 psi) is applied; and t is the wall thickness of the portion of the balloon with the larger exterior diameter.