Patent ID: 9132064
Filing Date: 2015-09-15
Classification: A61J,A61M,G01L

Abstract:
1. An indicator assembly for use in a medical device having a head located outside the human body and an inflatable retainer balloon for deployment within a lumen of a human body, the indicator assembly comprising: an inflatable thin-walled retainer balloon having a predetermined fill volume, the retainer balloon configured to contain a fluid under pressure upon inflation to its predetermined fill volume and after inflation further configured to contain a reserve volume of fluid that is less than the predetermined fill volume when the fluid is no longer under pressure; and an indicator in fluid communication with the retainer balloon, the indicator comprising a pre-biased indicator comprising a housing having an axial dimension, a flexible sleeve fitted within the housing, and a biasing element in communication with the flexible sleeve, the biasing element being configured to deform at a predetermined pressure so the flexible sleeve travels along the axis of the housing from a first axial position to a second axial position, the indicator being responsive at all times to actual pressure communicated from the retainer balloon, upon the actual pressure crossing a predetermined threshold pressure, the indicator providing only a first discrete visual signal at the first axial position when the retainer balloon is inflated to its predetermined fill volume and a second discrete visual signal at the second axial position when the fluid in the retainer balloon is no longer under pressure; whereby the second discrete visual signal provides warning that the retainer balloon volume has reached the reserve volume; and the indicator in direct fluid communication with the retainer balloon by way of a lumen that extends between the retention balloon and the indicator such that the retention balloon is supplied with the fluid under pressure prior to the indicator.