Method and apparatus for placing a catheter within a vasculature

Inventors

Farhangnia, MehrdadMiller, JohnTaber, MarkYang, Mark C.

Assignees

Roxwood Medical Inc

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Publication Number

US-11065028-B2

Patent

Publication Date

2021-07-20

Expiration Date


Abstract

A catheter for insertion into vasculature of a patient to a target area in the vasculature includes a hollow inner shaft, a non-occluding self-expandable scaffold coupled to the distal end of the inner shaft and disposed at the distal end of the inner shaft, and a hollow outer shaft. The outer shaft is slidable over the inner shaft and scaffold such that the scaffold is in a non-expanded state when the outer shaft is around the scaffold. The outer shaft has a state where the distal end of the outer shaft remains near the target area without the inner shaft and the scaffold being within the outer shaft. The inner shaft and the scaffold are removable through the proximal end of the outer shaft while the distal end of the outer shaft remains near the target area.

Core Innovation

The invention relates to a catheter apparatus and method for positioning a catheter close to an occlusion in a vasculature. The catheter apparatus includes a microcatheter, an outer shaft, and a non-occluding self-expandable scaffold, and the scaffold is positioned to expand within the vasculature to center the microcatheter and the scaffold.

The method tracks the catheter apparatus along a guidewire located in proximity to the occlusion and contacts a leading edge of the occlusion with a distal tip of the outer shaft. The non-occluding self-expandable scaffold is expanded to center the microcatheter and scaffold within the vasculature, and the guidewire and the microcatheter are advanced out of the distal tip through the occlusion.

After advancement through the occlusion, the microcatheter and the non-occluding self-expandable scaffold are withdrawn through a proximal opening in the outer shaft while the outer shaft remains near the occlusion in the vasculature. An instrument is then advanced through the proximal opening of the outer shaft and through the occlusion, with embodiments including an independently operable telescoping arrangement of outer and inner shafts and scaffold configurations including loop-based and lattice/cellular scaffolds.

Claims Coverage

The independent claim covers a method for positioning a catheter close to a vascular occlusion using a catheter apparatus with a microcatheter, an outer shaft, and a non-occluding self-expandable scaffold, including centering by scaffold expansion, advancing through the occlusion, withdrawing the microcatheter and scaffold while leaving the outer shaft near the occlusion, and then advancing an instrument through the outer shaft and through the occlusion. The claim coverage identifies 5 inventive features.

Centering using a non-occluding self-expandable scaffold

centering the microcatheter and the non-occluding self-expandable scaffold within the vasculature by expanding the non-occluding self-expandable scaffold within the vasculature

Tracking along a guidewire and contacting with an outer shaft leading edge

tracking the catheter apparatus along a guidewire located in proximity to the occlusion; contacting a leading edge of the occlusion with a distal tip of the outer shaft

Advancing guidewire and microcatheter through the occlusion

advancing the guidewire and the microcatheter out of the distal tip through the occlusion

Withdrawing microcatheter and scaffold while leaving outer shaft near the occlusion

withdrawing the microcatheter and the non-occluding self-expandable scaffold through a proximal opening in the outer shaft, wherein, after withdrawing the microcatheter and non-occluding self-expandable scaffold, the outer shaft remains near the occlusion in the vasculature

Advancing an instrument through the outer shaft into the occlusion

advancing an instrument through the proximal opening of the outer shaft and through the occlusion

Overall, the claim coverage centers on expanding the non-occluding self-expandable scaffold to center a microcatheter at an occlusion, advancing the guidewire and microcatheter through the occlusion, withdrawing the microcatheter and scaffold while leaving the outer shaft near the occlusion, and advancing an instrument through the remaining outer shaft into the occlusion.

Stated Advantages

Facilitates reliable central access.

Reduces off-axis deflection.

Reduces false-lumen entry.

Atraumatic non-occlusive anchoring to facilitate guidewire crossing.

Documented Applications

Positioning a catheter close to a chronic total occlusion (CTO) in a vasculature, to enable guidewire and microcatheter crossing and subsequent instrument advancement through the occlusion.

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