Subintimal recanalization with bio-absorbable stent

摘要

A recanalization catheter assembly and method for establishing a subintimal pathway around an occlusion in a blood vessel. The recanalization catheter assembly an inflatable balloon structure including a distal anchoring portion configured to expand within a true lumen portion of the blood vessel distal of the occlusion to anchor the recanalization catheter from unintentional movement during expansion of a stent in the subintimal pathway. The expandable stent, such as a bioabsorbable stent, may be configured to promote native tissue regrowth around the stent to create a superficial intimal layer along the subintimal pathway.

主权项

1. A recanalization catheter assembly for establishing a subintimal pathway around an occlusion in a blood vessel, the recanalization catheter assembly comprising:
an elongate catheter shaft extending distally from a hub assembly; an inflatable balloon structure mounted on a distal portion of the catheter shaft, the inflatable balloon structure configured to be expanded from a deflated configuration to an inflated configuration with a fluid delivered to an interior of the inflatable balloon structure through an inflation lumen extending through the catheter shaft; a stent surrounding a body portion of the inflatable balloon structure; wherein the inflatable balloon structure includes a proximal anchoring portion positioned proximal of the stent and a distal anchoring portion positioned distal of the stent; wherein the proximal anchoring portion of the inflatable balloon structure is configured to expand within a true lumen portion of the blood vessel proximal of the occlusion to anchor the recanalization catheter from unintentional movement during expansion of the stent in the subintimal pathway; wherein the distal anchoring portion of the inflatable balloon structure is configured to expand within a true lumen portion of the blood vessel distal of the occlusion to anchor the recanalization catheter from unintentional movement during expansion of the stent in the subintimal pathway; wherein the distal anchoring portion of the inflatable balloon structure has a radially outermost diameter in the inflated configuration greater than an outer diameter of the stent in a fully expanded configuration; and wherein the outermost diameter of the distal anchoring portion in the inflated configuration is greater than an outermost diameter of the proximal anchoring portion in the inflated configuration.