Balloon catheter including inner and outer balloons

摘要

An introducer assembly (10) includes a balloon catheter (12) for deploying a medical device (19) in a body lumen or for dilating a body lumen at a range of diameters from a minimum deployment diameter to a maximum deployment diameter. The balloon catheter includes an outer balloon (42) and an inner balloon (40) located within the outer balloon (42). The outer balloon (42) has an unstretched diameter equivalent to the minimum deployment diameter and the inner balloon (40) has an unstretched diameter equivalent to the maximum deployment diameter. The outer balloon (42) is made of an elastic material able to stretch from the minimum deployment diameter to the maximum deployment diameter, while the inner balloon (40) is preferably of an non-compliant material.

主权项

1. A balloon catheter for deploying a medical device in or for dilating a body lumen at a range of diameters from a minimum deployment or dilatation diameter to a maximum deployment or dilatation diameter, wherein the minimum deployment or dilatation diameter is selected to correspond substantially with a minimum expected diameter of a lumen type into which the medical device is to be fitted and the maximum deployment or dilatation diameter is selected to correspond substantially with a maximum expected diameter of the lumen type into which the medical device is to be fitted; the balloon catheter including a catheter body, an outer balloon having a proximal end and a distal end which are fixed to the catheter body and an inner balloon fixed to the catheter body located within the outer balloon; the outer balloon having an unstretched inflated diameter equivalent to the minimum deployment or dilatation diameter and the inner balloon having an unstretched inflated diameter equivalent to the maximum deployment or dilatation diameter; wherein the outer balloon is made of an elastic material able to stretch from the minimum to the maximum deployment or dilatation diameters; and wherein the elastic material of the outer balloon is uninflatable and is one of: vented and porous, and the inner balloon is made of an inflatable material that is not vented or porous;
wherein a minimum inflation applied to the inner balloon expands the inner and outer balloons to the minimum deployment or dilatation diameter at which the outer balloon is unstretched and attains a smooth outer surface, inflation beyond the minimum inflation stretching the outer balloon as the inner balloon unwraps from the minimum deployment or dilatation diameter to the maximum deployment or dilatation diameter, the outer balloon retaining the smooth outer surface from the minimum deployment or dilatation diameter to the maximum deployment or dilatation diameter; and wherein there is no port or lumen in the catheter body to feed an interior location between the inner balloon and the outer balloon.