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Publication Number

US-10786374-B2

Patent

Publication Date

2020-09-29

Expiration Date


Abstract

A stent (scaffold) or other luminal prosthesis comprising circumferential structural elements which provides high strength after deployment and allows for scaffold to uncage, and/or allow for scaffold or luminal expansion thereafter. The circumferential scaffold may be formed from degradable material, or may be formed from non-degradable material and will be modified to expand and/or uncage after deployment.

Core Innovation

The invention relates to an endoluminal prosthesis having a scaffold patterned from a non-degradable material that expands from a crimped configuration to a deployed configuration. The scaffold includes a plurality of circumferential rings, with at least some circumferential rings comprising struts joined by crowns and axially joined to adjacent circumferential rings. At least some circumferential rings have at least one separation region arranged along a length of the prosthesis in a helical pattern.

The separation regions comprise a lock and key junction or a pair of structures made from non-degradable material, including ball and socket, disc and cap, tongue in slot, interlocking combs, interlocking teeth, grooves or V’s or U’s with suitable opposing shapes, or wavy or undulating interlocking surfaces. The lock and key or pair of structures are held together during expansion with a degradable material and separate after expansion in a physiologic environment.

In additional embodiments, the separation regions include a pre-formed break or gap in the strut of the circumferential ring, with a male portion on one side and a female portion on the other side. The separation regions are joined by, covered by, or embedded in a biodegradable polymer and/or adhesive that degrades in a physiologic environment, and the prosthesis is configured to separate into at least two segments.

Claims Coverage

The document provides three independent claims. The claims collectively cover a non-degradable expandable endoluminal prosthesis with circumferential rings and helical separation regions that remain joined during expansion and separate after deployment in a physiologic environment, using degradable material and specific junction geometries.

Non-degradable expandable scaffold with helical separation regions

A scaffold having a plurality of circumferential rings patterned from a non-degradable material, configured to expand from a crimped configuration to a deployed configuration, where at least some rings comprise struts joined by crowns, at least some rings are axially joined to adjacent circumferential rings, and at least some rings have at least one separation region arranged in a helical pattern along a length of the prosthesis.

Lock-and-key junction held during expansion and separated after deployment

The at least one separation region comprises a lock and key junction with lock and key comprising non-degradable material, where the lock and key are configured to be held together during expansion with a degradable material and to separate after expansion of the scaffold to the deployed configuration in a physiologic environment.

Paired interlocking structures in helical separation regions

The at least one separation region comprises a pair of structures comprising one or more of a ball and socket, disc and cap, tongue in slot, interlocking combs, interlocking teeth, grooves or V’s or U’s with suitable opposing shapes, or wavy or undulating interlocking surfaces, each pair comprising non-degradable material, and the pair of structures are configured to be held together during expansion with a degradable material and to separate after expansion of the scaffold to the deployed configuration in a physiologic environment.

Pre-formed break or gap with male and female portions joined by biodegradable polymer or adhesive

The separation regions comprise a pre-formed break or gap in the strut of the circumferential ring, with a male portion on one side and a female portion on the other, and the separation regions are joined by, covered by, or embedded in a biodegradable polymer and/or adhesive which degrades in a physiologic environment and are configured to be held together during expansion and to separate after expansion of the scaffold to the deployed configuration in a physiologic environment.

Across the independent claims, the core claim coverage is directed to a non-degradable expandable scaffold with circumferential rings and helical separation regions, where non-degradable lock-and-key or paired interlocking structures, or male/female portions at pre-formed breaks or gaps, are held together during expansion by degradable or biodegradable material and separate after deployment in a physiologic environment.

Stated Advantages

Enables uncaging to increase compliance over time after deployment while maintaining high initial radial strength.

Supports vessel functionality including vasomotion, vasodilation, and vasoconstriction response.

Improves performance relative to conventional metallic/biodegradable stents that can experience recoil/jailing, impaired vasomotion/vasodilation, bulky struts, fracture, and insufficient strength/compliance over time.

Enables separation after expansion of the scaffold to the deployed configuration in a physiologic environment.

Allows the prosthesis to remain held together during expansion while separation is configured to occur after deployment.

Documented Applications

Endoluminal implantation using a luminal stent/prosthesis scaffold configured to separate after expansion in a physiologic environment, enabling vessel functionality such as vasomotion, vasodilation, and vasoconstriction response.

Use in a physiologic environment as an endoluminal prosthesis configured to separate after expansion to a deployed configuration.

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