Serration balloon

Inventors

Schneider, Peter • Giasolli, Robert M.

Assignees

Cagent Vascular Inc

Abstract

A serration balloon can have a number of different components and can be made in a number of different manners. One or more longitudinally extending members with periodic raised wedges can be attached to a medical balloon. They can be attached with a fiber coating, a polymer coating, or other methods. A polymer matrix can be used to bond the longitudinally extending member to the surface of the balloon. The fiber coating can be, for example, a thread or mesh that secures the longitudinally extending member to the balloon. The medical balloon can be an angioplasty balloon, such as an off-the-shelf angioplasty balloon.

Core Innovation

The invention provides a serration balloon and a method of manufacturing a serration balloon in which an off-the-shelf angioplasty balloon is combined with longitudinally extending members in the form of cutting blades. Each cutting blade comprises a strip of material with periodic raised wedges spaced along a length thereof, with wedge features configured to protrude for plaque scoring during balloon use.

A medical balloon is inflated and the cutting blades are attached along a surface of the medical balloon in the inflated state. Attachment is performed by applying an adhesive between the strip of material and the medical balloon, and a second balloon retains the cutting blades. The described approaches for blade attachment and retention include using fiber coatings such as thread or mesh, and bonding in a polymer matrix including multi-layer polymer matrix and over-mold so that the blades are sandwiched between polymer layers while the raised wedge features protrude.

The document describes additional structural and geometric options for the raised wedge cutting blades and their orientation relative to the balloon surface, including a blade primary plane oriented perpendicular to the balloon surface and wedges that are non-hollow. It also describes optional drug/STEM-cell doping via ionic bonding manipulation, and a background assertion that controlled expansion and an energy angle (tangential force at angles of =45b0) promote controlled tearing of plaque.

Claims Coverage

The document includes three independent claims, each directed to manufacturing a serration balloon by inflating a medical balloon and attaching cutting blades in an inflated state, where the blades are strip-based with periodic raised wedges, and the claims distinguish the retention structure (second balloon, mesh, or fiber).

Across the independent claims, the core shared inventive concept is the adhesive attachment of periodic raised wedge cutting blades to a medical balloon while the balloon is inflated, with retention provided by a second balloon, a mesh, or a fiber respectively.

Stated Advantages

Documented Applications