Catheter system for stenting and drug treatment of bifurcated vessels

Inventors

Hilaire, Pierre • Van Der Leest, Machiel

Assignees

Envision Scientific Pvt Ltd

Abstract

A catheter system and method are described for stenting a vessel at a bifurcation or sidebranch of the vessel. The catheter system includes a first balloon catheter, a second balloon catheter and a releasable linking device for holding the first and second balloon catheters arranged in a side-by-side configuration and aligned with one another along a longitudinal axis so that the catheter system can be advanced as a unit. The catheter system is combined with drug eluting technology to prevent restenosis, inflammation and/or thrombosis and/or to promote reendothelialization in the vessel bifurcation. The main vessel stent and/or the sidebranch stent may be coated or impregnated with one or more drugs or bioactive substances. Alternatively or in addition, the first balloon and/or the second balloon may be coated with or include a mechanism for delivering one or more drugs or bioactive substances to the vessel wall.

Core Innovation

The invention provides a catheter system that includes a first rapid exchange balloon dilatation catheter and a second rapid exchange balloon dilatation catheter. Each catheter has a shaft with a proximal end and a distal end, where a proximal section is constructed of hypodermic tubing joined to a flexible distal section carrying an inflatable balloon. An expandable stent is mounted on the first inflatable balloon, and at least one of the stent, the first balloon, or the second balloon is configured to deliver a drug or bioactive substance to a vessel wall.

An elongated split-tube linking device links the proximal sections. The split-tube linking device has an inner lumen and a longitudinal split through a wall of the split-tube linking device that connects the inner lumen with an exterior of the split-tube linking device, and a distal pull-tab is located on a side opposite to the longitudinal split. The split-tube linking device has a linked position in which the inner lumen holds the proximal sections together with sufficient friction to allow the catheter system to be advanced as a unit without any relative longitudinal movement.

The same split-tube linking device can be released into a released position to allow longitudinal movement of the first and second rapid exchange balloon dilatation catheters with respect to each other. This provides a linked-then-released catheter system architecture for delivering and deploying an expandable stent with drug delivery functionality to the vessel wall.

Claims Coverage

The relevant disclosure contains one independent claim describing a rapid exchange catheter system with two balloon dilatation catheters linked by an elongated split-tube linking device, an expandable stent mounted on the first balloon, and drug or bioactive substance delivery to a vessel wall. The independent claim includes the core inventive combination of linked advancement and releasable longitudinal movement, plus configurable drug delivery among the stent and/or balloons.

Across the independent claim, the inventive focus is on a two-catheter rapid exchange balloon dilatation system that is advanced as a linked unit via an elongated split-tube linking device with a distal pull-tab and then allows relative longitudinal movement after release, while carrying an expandable stent mounted on the first balloon and enabling drug or bioactive substance delivery to the vessel wall.

Stated Advantages

Documented Applications

No documented applications found