Catheter assemblies and methods for stabilizing a catheter assembly within a subintimal space

Inventors

Silvestro, Claudio

Assignees

Invatec SpA

Abstract

Catheter assemblies include a stabilization mechanism disposed at a distal end of the catheter assembly for stabilizing the catheter assembly within a subintimal space. The stabilization mechanism includes a self-expanding support structure that is slidably positionable within an inflatable balloon. The catheter assemblies include an outer shaft which has the balloon at a distal end thereof and an inner shaft which has the support structure mounted on a distal end thereof. The inner shaft is slidably disposed within a lumen of the outer shaft and has a first configuration in which the support structure is held in a compressed state within the outer shaft and a second configuration in which the support structure is permitted to return to an expanded state within the inflatable balloon. In the expanded state, the stabilization mechanism has a flattened laterally-extending profile.

Core Innovation

The patent describes a catheter assembly for stabilizing within a subintimal space, using an outer shaft with an inflatable balloon having an inflated state and an uninflated state at a distal end. The inflatable balloon is an integral portion of the outer shaft, with the proximal end of the balloon coupled to a proximal portion of the outer shaft and the distal end coupled to a distal tip portion of the outer shaft. The catheter assembly further includes an inner shaft disposed within a lumen of the outer shaft, the inner shaft being movable relative to the outer shaft and carrying a self-expanding support structure on a distal portion of the inner shaft.

The self-expanding support structure is held in a compressed state within the outer shaft in a first configuration and is permitted to return to an expanded state within the inflatable balloon in an uninflated state in a second configuration. When the support structure returns to the expanded state, it dictates a flattened laterally-extending profile of the inflatable balloon in its inflated state. Together, the inflated balloon and the expanded support structure are configured for stabilizing the catheter assembly within a subintimal space.

The patent describes how the flattened laterally-extending profile is achieved by wing-like features of the support structure, including first and second wings that bow outward in opposite directions in the expanded state. The flattened balloon profile is described as having opposing triangular portions formed by the first and second wings. Structural implementations described include first and second longitudinally extending bands forming the wings that bridge proximal and distal tube segments, with optional thinner or weakened joints for selective bending, and alternative mechanisms for allowing expansion by alignment with sidewall openings. In some configurations, the proximal portion of the outer shaft, the distal tip portion of the outer shaft, and the balloon together form a continuous lumen through the device.

Claims Coverage

The provided material includes three independent claims directed to catheter stabilization in a subintimal space using an inflatable balloon whose inflated profile is flattened and dictated by a self-expanding support structure, with claim-to-claim differences centered on how expansion is permitted and the presence of sidewall openings and the balloon/support geometry. Across these independent claims, the main inventive features are the coordinated compressed-to-expanded behavior, flattened laterally-extending profile shaping, and anchoring stabilization in the subintimal space.

Across the independent claims, stabilization within a subintimal space is achieved by a self-expanding support structure that transitions from a compressed state to an expanded state within an inflatable balloon, where the expanded support structure dictates a flattened laterally-extending balloon profile used to anchor the catheter assembly. One independent claim additionally requires an outer shaft sidewall opening that permits the support to return to the expanded state, while another independent claim defines a distal anchoring stabilization mechanism where positioning of the expanded support within an uninflated balloon causes the inflated balloon to exhibit a corresponding flattened profile.

Stated Advantages

Documented Applications