Systems and method for stent manufacturing using protective shields

Inventors

Senin, Vladlen • Stein, Oded

Assignees

Medinol Ltd

Abstract

The present disclosure is directed to a stent manufacturing assembly including an inner shield, a patterned metal sheet, and an outer shield. The patterned metal sheet may include a polymer coating with an embedded therapeutic agent. The inner shield, patterned metal sheet, and outer shield are arranged in a layered configuration and placed in a stent rolling mechanism with a mandrel. In particular, the patterned metal sheet is disposed on the outer shield and the inner shield is disposed on the patterned metal sheet in the layered configuration. In the layered configuration, the stent manufacturing assembly is rolled by the rolling mechanism into a tubular shape and welded to form a tubular stent.

Core Innovation

The disclosed invention relates to a stent manufacturing assembly that includes an outer shield, a patterned metal sheet, and an inner shield configured to protect different sides of the patterned sheet during stent formation. The outer shield has an outer cutout portion and an outer alignment portion, and the patterned metal sheet is positioned on the outer shield with a stent portion and a stent alignment portion. The inner shield has an inner cutout portion and an inner alignment portion and is positioned on the patterned metal sheet.

During rolling into a tubular stent, the assembly includes cutout features that enable access to selected regions while shielding other regions of the patterned metal sheet. The cutout edges are described as jagged or toothed long edges, and the shielding arrangement provides gaps for argon gas, illumination, or laser welding during formation. Alignment is implemented using alignment holes and/or alignment pins associated with the outer alignment portion, the patterned sheet stent alignment portion, and the inner alignment portion.

The invention further describes forming and joining the stent portion by welding long edges after rolling around a mandrel, and then removing the tubular stent from the mandrel. The documented disclosure includes optional removal of the protective shields, including outer shield and/or inner shield, and discusses that a flat sheet configuration can achieve coating uniformity on the patterned metal sheet when the sheet is optionally coated with a polymer and an embedded therapeutic agent such as an anti-proliferative drug.

Claims Coverage

The partial document identifies two independent claims. The inventive features focus on a layered shielded assembly structure and a rolling-and-welding method using that assembly.

Across the independent claims, the core claim coverage centers on an outer shield/patterned metal sheet/inner shield layered assembly with cutout and alignment portions and a manufacturing method that rolls the shielded cutout and stent portions around a mandrel, welds long edges to form a tubular stent, and removes the tubular stent from the mandrel.

Stated Advantages

Documented Applications