Catheter system for stenting bifurcated vessels

Inventors

Der Leest, Machiel Van • Pasquier, Lydie • Berc, Olivier

Assignees

Envision Scientific Pvt Ltd

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Publication Number

US-7695508-B2

Patent

Publication Date

2010-04-13

Expiration Date


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. The linking device allows the catheter system to be advanced as a unit and helps prevent premature or inadvertent dislodgement of the stent from the catheters, yet is releasable so that one or both of the balloon catheters can be released from the linking device and maneuvered separately from the rest of the catheter system when desired. The method utilizes the described catheter system for stenting bifurcated vessels using a modified “kissing balloons” technique.

Core Innovation

A catheter system is provided that includes a first balloon catheter with a first inflatable balloon and a second balloon catheter with a second inflatable balloon and an elongated flexible extension tube extending distally from the second inflatable balloon. In an undeployed state with the first inflatable balloon in a deflated condition, at least a portion of the first inflatable balloon is wrapped around a portion of the flexible extension tube, allowing the flexible extension tube to be carried by the deflated first balloon during the undeployed state.

The catheter system further specifies a tandem arrangement in which the flexible extension tube is positioned alongside the first inflatable balloon, with a proximal portion of the first inflatable balloon wrapped around a portion of the flexible extension tube. A distal tip of the flexible extension tube is exposed from under the first inflatable balloon at an intermediate point between a proximal portion of the first inflatable balloon and a distal portion of the first inflatable balloon, and folding configurations may include wing portions wrapped around portions of the flexible extension tube.

A releasable proximal linking device can link the first and second balloon catheters in a side-by-side configuration with longitudinal-axis alignment and enable advancing the catheter system as a unit prior to release. In embodiments, the linking device includes an elongated split-tube with an inner lumen configured to hold the shaft of each balloon catheter together with sufficient friction such that the catheter system can be advanced without any relative longitudinal movement between the first and second balloon catheters. The system also includes an assembly concept where a stent is mounted on the first inflatable balloon so that a distal tip of the flexible extension tube is exposed through a side opening in the stent.

Claims Coverage

The document includes three independent claims. Across these claims, the inventive features focus on the undeployed wrapping and tandem positioning of an elongated flexible extension tube relative to a deflated first inflatable balloon, exposure of a distal tip at an intermediate location including through a side opening in a stent, and a releasable proximal linking device for side-by-side aligned balloon catheters with movement constraints in linked form.

Wrapped deflated first balloon around flexible extension tube in undeployed state

In an undeployed state with the first inflatable balloon in a deflated condition, at least a portion of the first inflatable balloon is wrapped around a portion of the flexible extension tube.

Tandem positioning with proximal wrap and intermediate distal tip exposure

In an undeployed state with the first inflatable balloon and the second inflatable balloon in a deflated condition, the first inflatable balloon and the second inflatable balloon are in a tandem configuration with the flexible extension tube positioned alongside the first inflatable balloon, wherein a proximal portion of the first inflatable balloon is wrapped around a portion of the flexible extension tube, and a distal tip of the flexible extension tube is exposed from under the first inflatable balloon at an intermediate point between the proximal portion of the first inflatable balloon and a distal portion of the first inflatable balloon.

Stent mounted on deflated first balloon with extension distal tip exposed through side opening

Mounting a stent on the first inflatable balloon including at least a portion of the first inflatable balloon that is wrapped around a portion of the flexible extension tube with a distal tip of the flexible extension tube exposed through a side opening in the stent.

Releasable side-by-side proximal linking device with longitudinal-axis alignment

A linking device attachable near the proximal ends of the catheters for releasably linking the first balloon catheter and the second balloon catheter together in a side-by-side configuration and with the first catheter and the second catheter aligned with one another along a longitudinal axis.

Elongated split-tube linking with sufficient friction to prevent relative longitudinal movement

A linking device with an elongated split-tube whose inner lumen is sized and configured to hold the shaft of the first balloon catheter and the shaft of the second balloon catheter together with sufficient friction that the catheter system can be advanced as a unit without any relative longitudinal movement between the first balloon catheter and the second balloon catheter.

Overall, the claims concentrate on configuring the deflated first inflatable balloon to wrap around an elongated flexible extension tube carried by a second balloon catheter, exposing the distal tip of the flexible extension tube at an intermediate location and through a side opening in a stent mounted on the deflated first balloon, and using a releasable proximal linking device to couple two balloon catheters in a side-by-side, longitudinally aligned arrangement with movement constraints in the linked state.

Stated Advantages

Enables advancing the catheter system as a unit to reduce premature stent dislodgement.

Allows the linking device to be released so one or both catheters and optional guidewires can be maneuvered separately.

Provides for distal tip exposure at an intermediate location to enable smoother stent crimping and crossing.

Documented Applications

Stenting bifurcated and sidebranch vessels using side-by-side kissing balloons and low-profile staggered tandem modified kissing balloons configurations.

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