Uncaging stent
Inventors
Sirhan, Motasim • Yan, John • Bhat, Vinayak • Paraschac, Joseph • Cryer, Brett • Serna, Benjamyn
Assignees
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Publication Number
US-10918505-B2
Publication Date
2021-02-16
Expiration Date
Abstract
A stent (scaffold) or other luminal prosthesis comprising circumferential structural elements which provide high strength after deployment and allows for scaffold to uncage, and/or allow for scaffold or luminal expansion thereafter. The circumferential scaffold is typically 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 with a scaffold patterned from a non-degradable material. The scaffold includes a plurality of circumferential rings with struts joined by crowns, and at least two adjacent circumferential rings are circumferentially separable and joined by at least one circumferentially separable axial link. The scaffold is expandable from a crimped configuration to an expanded deployed configuration in a physiologic environment.
The separable axial links and the separable circumferential rings are configured to be held together during expansion and to separate after expansion of the scaffold to the deployed configuration. After separation, the scaffold is configured to form one continuous structure with sufficient strength in the deployed configuration to support a body lumen. Separation regions create discontinuities and increase radial compliance and radial strain after discontinuity formation while the scaffold supports a body lumen.
The disclosed embodiments include separation regions arranged on ring and/or link structures, including ring, strut, and crown location of separations and separable axial links configured with non-linear or curved interfaces, including S/Ω/U/Z/W-shaped geometries. The disclosure also describes options for maintaining continuity during deployment via degradable or non-degradable adhesive or sleeve arrangements, and defines discontinuities, bisection, and uncaging behavior in physiologic conditions.
Claims Coverage
The independent claim coverage centers on a non-degradable ring-and-link scaffold that deploys from a crimped to an expanded configuration in a physiologic environment while separable axial links and separable circumferential rings are held together during expansion and then separate after expansion, after which the scaffold forms one continuous structure with sufficient deployed strength to support a body lumen. Four inventive features are identified.
Non-degradable ring-and-link scaffold with circumferential rings and axial links
The scaffold is patterned from a non-degradable material and includes a plurality of circumferential rings, the rings comprising struts joined by crowns, where at least two adjacent circumferential rings are circumferentially separable and the adjacent circumferential rings are joined by at least one circumferentially separable axial link.
Crimp-to-expanded deployment with held-together separable links
The scaffold is expandable from the crimped configuration to an expanded deployed configuration in a physiologic environment, where the separable axial link and separable circumferential rings are configured to be held together during expansion.
Post-expansion separation to form a continuous structure
The separable axial link and separable circumferential rings are configured to separate after expansion of the scaffold to the deployed configuration in a physiologic environment, and the scaffold is configured to form one continuous structure after all separable rings and all separable axial links have separated.
Sufficient deployed strength to support a body lumen
The scaffold has sufficient strength in the deployed configuration to support a body lumen.
Overall, the claim coverage centers on coordinated separable axial links and separable circumferential rings that remain connected during crimped-to-expanded expansion and then separate after deployment, while the scaffold ultimately forms one continuous structure with enough strength to support a body lumen.
Stated Advantages
Improved vasomotion/area changes after formation of discontinuities.
Reduced mechanical bending/stress after formation of discontinuities.
Bench tests and model/FEA/model testing indicate quantified force/stress reductions.
Allows the scaffold to separate during expansion after deployment to reach an expanded deployed configuration in a physiologic environment while then forming one continuous structure.
Provides sufficient strength in the deployed configuration to support a body lumen.
Increased radial compliance and radial strain after discontinuity formation.
Prevention of ring opening during crimped-to-expanded delivery.
Decreased radial strength over time.
Increased compliance and displacement while maintaining enough strength and crush resistance to support the lumen in the physiologic environment.
Documented Applications
Used as an endoluminal prosthesis having a scaffold expandable to a deployed configuration in a physiologic environment to support a body lumen.
Endoluminal prostheses/stents or scaffolds intended for deployment in a physiologic environment to support a body lumen.
Inclusion of biologically active agents, including mTOR inhibitors such as sirolimus-family compounds, in the device.
Endoluminal implantation in a physiologic environment to support a body lumen.
Valve replacement or repair.
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