Catheter system for protected angioplasty and stenting at a carotid bifurcation

Inventors

Theron, Laurence • Hilaire, Pierre • Van Der Leest, Machiel

Assignees

Envision Scientific Pvt Ltd

Abstract

A catheter system is described for performing protected angioplasty and stenting of a patient's carotid bifurcation. A self-expanding stent is deployed across a stenosis in the patient's carotid artery. A catheter system that includes a rapid exchange angioplasty catheter with an occlusion balloon catheter positioned through the guidewire lumen is advanced through the guiding catheter to the distal end of the stent. A releasable linking device holds the catheter system together as a unit. The occlusion balloon is inflated within the stent to occlude the carotid artery and to prevent any embolic debris from traveling downstream from the treatment site. The angioplasty balloon is inflated to dilate the stenosis and to complete the expansion of the stent. The angioplasty catheter is withdrawn and any potential embolic debris is aspirated out through the lumen of the guiding catheter. The occlusion balloon is deflated and the catheter system is withdrawn.

Core Innovation

The invention provides a catheter system for protected angioplasty in which a rapid exchange angioplasty catheter and an embolic protection device are mechanically connected during insertion and then separated during use. The rapid exchange angioplasty catheter includes an inflatable angioplasty balloon and a guidewire lumen that extends through the catheter shaft to a proximal guidewire port, and the embolic protection device extends through the guidewire lumen so the two devices are advanced together as a unit.

A linking device releasably links the rapid exchange angioplasty catheter and the embolic protection device. In a linked position, the linking device links the catheter shaft of the rapid exchange angioplasty catheter with the shaft of the embolic protection device and prevents relative longitudinal movement between them; in a released position, the catheter shafts are released to allow relative longitudinal movement and independent manipulation after advancement.

In further embodiments, the embolic protection device is an occlusion balloon catheter having a tubular shaft and an inflatable occlusion balloon near a distal end. The linking device is a split-tube with an inner lumen sized and configured to hold the catheter shafts together, and release is initiated using a tab located near a distal end of the split-tube, where the catheter shafts are released through a slit in a side wall of the split-tube.

Claims Coverage

The document provides three independent claims. Across these claims, the main inventive features are a rapid exchange angioplasty catheter with a guidewire lumen and guidewire port, an embolic protection device extending through the guidewire lumen, and a releasable linking device that prevents relative longitudinal movement during advancement and enables release thereafter; one independent claim also includes protected angioplasty and stenting of a patient's carotid artery.

Across the independent claims, the central claim coverage is a catheter system that links a rapid exchange angioplasty catheter and an embolic protection device through extension of the embolic device shaft through the angioplasty guidewire lumen, where a linking device provides a linked position that prevents relative longitudinal movement during advancement and a released position that allows relative longitudinal movement. The claim coverage further includes a split-tube linking device with a distal tab and side-wall slit for initiating release, and one independent claim includes protected angioplasty and stenting of a patient's carotid artery using a precurved guiding catheter and a self-expanding stent.

Stated Advantages

Documented Applications