Stent apparatus and treatment methods

Inventors

Caro, Colin Gerald • Burke, Martin G. • Gilson, Paul • Heraty, Kevin B. • Yeo, Nicholas

Assignees

Veryan Medical Ltd

Abstract

There is disclosed a method of treating hypoxia in tissue of a blood vessel, the method comprising placing a stent in the vessel, the stent having a center line which curves in three dimensions to promote the supply of oxygen from the blood flowing in the lumen of the stented vessel to the vessel wall. There is disclosed a method of treating a subject with diabetic atherosclerosis, the method comprising placing a stent in a blood vessel of the subject, the stent having a center line which curves in three dimensions to promote the supply of oxygen from the blood flowing in the lumen of the stented vessel to the vessel wall.

Core Innovation

The invention relates to a stent-based therapy for a subject for whom blood vessel stenting is indicated, where treatment is configured to address vascular hypoxia and diabetic atherosclerosis. The method identifies a treatment site and determines whether the natural vessel geometry at that treatment site will impart right-handed swirl flow or left-handed swirl flow to the blood flow along the vessel.

Based on the determined swirl flow handedness, the method selects a stent having a centre line with three-dimensional curvature. The selected stent is chosen to match the swirl handedness by providing right-handed curvature if the vessel imparts right handed swirl flow and left-handed curvature if the vessel naturally imparts left handed swirl flow.

The three-dimensional curvature, including a helical centre line, is described as promoting intraluminal swirling and oxygen transport to the vessel wall through oxygen supply and transmural diffusion. The configuration is also described as reducing hypoxia- and angiogenesis-related markers associated with vascular hypoxia, including adventitial micro vessel density, and as reducing intimal hyperplasia and restenosis.

The disclosure further includes determining swirl-flow handedness at a treatment site and selecting between right- and left-handed stents accordingly. A stent kit with right- and left-handed curvature, an apparatus for performing the method, and imaging methods including Doppler ultrasound, CT, MRI, C-Arm cone beam CT, digital subtraction angiography, and computational fluid dynamics are described.

Claims Coverage

The independent claim set is anchored by a single independent method claim. Across the dependent features, the claims refine how swirl-flow handedness is determined and how the stent is selected and positioned, including vessel-location mapping, downstream-of-bifurcation placement, and stent material constraints.

Overall, the claims center on selecting a three-dimensionally curved stent whose handed curvature is matched to the handedness of swirl flow imparted by the natural vessel geometry at the treatment site, with refinements for determining swirl direction, mapping vessel locations, and constraining stent placement and material.

Stated Advantages

Documented Applications