Medical device balloons with improved strength properties and processes for producing same
AssigneeBoston Scientific Scimed, Inc.
InventorsLixiao Wang, Jeffrey S. Lindquist, Pao Nao Lee, John Jianhua Chen, Douglas A. Devens
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Abstract
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.
Claims15
An expandable medical balloon, the expandable medical balloon comprising:
- a balloon wall comprising a 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)
- where 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 pressure of 6 kg/cm2 (85.2 psi) is applied;
- and t is the wall thickness (mm) of the portion of the balloon with the larger exterior diameter.
Dependencies are inferred from the claim text.