Catheter balloon liner with variable thickness and method for making same

Abstract

A method of making a catheter balloon, and a balloon catheter formed thereby, in which a layer of a catheter balloon is formed by providing a tubular member to serve as a non porous liner for cooperation with a polymeric tube, and enlarging radially a central or working section of the tubular member such that a first end of the tubular member is smaller in the radial direction with respect to the working section. The tubular member may also have a thickness at the working section that is less than a thickness of the first and second end portions. The first end section of the tubular member is bonded to a catheter shaft having a first outer diameter to form at least a portion of a skirt section of the balloon, and the second end section is bonded to the catheter shaft having a second outer diameter to form a portion of a skirt section, where the skirt sections have an improved high rupture pressure.

Description

BACKGROUND OF THE INVENTION [0001] This invention generally relates to catheters, and particularly intravascular catheters for use in percutaneous transluminal coronary angioplasty (PTCA) or for the delivery of stents. [0002] In percutaneous transluminal coronary angioplasty (PTCA) procedures a guiding catheter is advanced in the patient's vasculature until the distal tip of the guiding catheter is seated in the ostium of a desired coronary artery. A guidewire is first advanced out of the distal end of the guiding catheter into the patient's coronary artery until the distal end of the guidewire crosses a lesion to be dilated. A dilatation catheter, having an inflatable balloon on the distal portion thereof, is advanced into the patient's coronary anatomy over the previously introduced guidewire until the balloon of the dilatation catheter is properly positioned across the lesion. Once properly positioned, the dilatation balloon is inflated with inflation fluid one or more times to a...

AI Technical Summary

Benefits of technology

The modified liner configuration enhances the balloon's integrity and rupture resistance, allowing for higher inflation pressures without premature rupture, and results in a lower profile design.

Problems solved by technology

One difficulty has been providing an ePTFE balloon with sufficiently high rupture pressure.

Some liner bonding techniques such as laser bonding the liner tubing to the outer surfaces of the catheter shaft results in wall thinning of the tubular liner in proximity with the bonding area.

This reduction in wall thickness of the liner can be uneven and result in thin spots or weakened areas that place the integrity of the balloon at risk.

Upon inflation of the balloon to elevated pressures of eight atmospheres or higher, these weaknesses due to the liner thinning at the bonding surfaces may lead to early rupture of the balloon.

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