Balloon catheter including drug delivery sheath

Abstract

A balloon catheter includes an elongated catheter shaft, an expandable balloon connected to the elongated catheter shaft, and a sheath that defines a lumen and includes a therapeutic agent disposed within the lumen. The balloon catheter further includes a first configuration and a second configuration. When in the first configuration, the expandable balloon is disposed distally from the sheath such that an outer surface of the expandable balloon does not contact the lumen. Further, when in the second configuration, at least a portion of the outer surface of the expandable balloon is disposed within the lumen of the sheath such that it contacts the therapeutic agent. At least a portion of the therapeutic agent that contacts the outer surface of the expandable balloon is transferred from the lumen of the sheath to the outer surface of the expandable balloon when the balloon catheter is in the second configuration.

Description

technical field [0001] The present invention relates to a drug-coated balloon catheter, and more particularly to a balloon catheter including a drug delivery sheath. Background technique [0002] Blockages in blood vessels, such as arterial blockages, are routinely treated using percutaneous transluminal angioplasty (PTA), in which an inflatable balloon is used to push away and dilate the lumen of the blocked blood vessel. However, PTA may cause vascular intimal hyperplasia and correspondingly arterial restenosis, which causes the lumen of the vessel to constrict again and become at least partially occluded. In recent years, the use of drug-coated balloons has evolved to provide minimally invasive procedures to avoid and prevent restenosis of arteries. However, in such procedures, both conventional PTA balloon catheters and drug-coated balloon catheters are often used. For example, conventional PTA balloon catheters are first used to mechanically pre-dilate an intravascula...

AI Technical Summary

Problems solved by technology

In addition, the expandable sheath may not be compliant and therefore may not make good contact with the vessel wall and / or occlusion

Also, the sheath may not be made of the same materials that have historically been used to manufacture inflatable balloons, potentially compromising compatibility with therapeutic agents and the ability to deliver drugs to the vessel wall

Furthermore, the materials used to make sheaths are often not compliant, and balloon-driven expansion can cause significant changes in the sheath's porosity, mechanical properties, or physical properties, thereby affecting effective sheath loading and delivery The ability of the therapeutic agent

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