US 2026/0102265 A1 · POLYMER STENT FOR BELOW THE KNEE TREATMENT OF PERIPHERAL ARTERY DISEASE

Abstract

Disclosed are methods of treating peripheral artery disease (particularly chronic limb threatening ischemia (CLTI)) with implantation of a polymeric scaffold into a vessel located below the knee. After implantation into a blood vessel of the patient below the knee, efficacy of the procedure is measured by performing duplex ultrasound (DUS) and/or angiography to measure binary restenosis at the site of the target lesion, where binary restenosis is defined as the presence of a hemodynamically significant restenosis of >50% identified through angiography, or peak systolic velocity ratio (PSVR) ≥2.0 as identified by DUS. The scaffold is made from a bioresorbable polymer. The scaffold has a pattern of interconnected elements. The interconnected elements include a plurality of rings connected by links, wherein each ring includes struts and crowns, and the struts are configured to fold at the crowns when the scaffold is crimped to a balloon.

Claims68

Dependent claims

A method for treating peripheral artery disease (PAD) below the knee, comprising:

inserting into a peripheral artery below a knee at a site of a target lesion of a subject a scaffold made from a material comprising a polymer,
the scaffold having a pattern of interconnected elements, the interconnected elements comprising struts and links, and
performing duplex ultrasound (DUS) and/or angiography after inserting the scaffold into the peripheral artery below the knee to measure binary restenosis at the site of the target lesion,
wherein the binary restenosis is defined as the presence of a hemodynamically significant restenosis of >50% identified through angiography, or peak systolic velocity ratio (PSVR) ≥2.0 as identified by DUS.

1 more element

A method for treating peripheral artery disease (PAD) below the knee, comprising:

inserting into a peripheral artery below the knee at the site of a target lesion of a target vessel of a subject a scaffold made from a material comprising a polymer, the scaffold having a pattern of interconnected elements, the interconnected elements comprising struts and links, the scaffold being configured to, within 1 year of inserting the scaffold into the peripheral artery, reduce, relative to balloon angioplasty, the risk of all of the following in the patient:
(1) a total occlusion of the target vessel, (2) a binary restenosis of the target lesion, and (3) a clinically driven target lesion revascularization (CD-TLR);
and
periodically performing duplex ultrasound (DUS) after inserting the scaffold into the peripheral artery below the knee to measure binary restenosis at the site of the target lesion, wherein the binary restenosis is defined as the presence of the restenosis being a hemodynamically significant restenosis of >50% identified through angiography, or a peak systolic velocity ratio (PSVR) ≥2.0 as identified by DUS.

1 more element

Dependencies are inferred from the claim text.

Polymer stent for below the knee treatment of peripheral artery disease

Life of this patent

Polymer stent for below the knee treatment of peripheral artery disease

Life of this patent

Abstract

Claims68