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Publication Number
US-8672996-B2
Publication Date
2014-03-18
Expiration Date
Abstract
The invention relates to a helical coil comprising multiple reversing sense helical coil units that are capable of drug elution, come in lengths appropriate for long, diffuse lesions, have the ability to have a step-wise tapering diameter, and provide all the benefits of a small closed cell stent design while maintaining high flexibility, high radial force and crush resistance due to an underlying helical coil.
Core Innovation
The invention relates to a self-expanding helical-coil medical device for placement in a lumen. The device includes a plurality of segments in which each segment comprises a first helical coil and a second helical coil of opposing winding sense, and adjacent segments are connected by a first structure that changes the winding sense through a cross-over point where an end of one helical coil overlaps an end of the opposing helical coil and the ends are joined.
Each first structure extends into and fills a gap created by divergence of the segments connected to the first structure. The first structure pushes the end of the first helical coil and the end of the second helical coil against a wall of the lumen and exerts force on the lumen. The segment-to-segment linkage is described in terms of left-hand and right-hand helical coil units joined by link structures that change winding sense and fill divergence gaps.
The disclosed device further supports drug elution and enhanced mechanical behavior for intraluminal placement, including high flexibility, high radial force, and crush resistance. A covering may be attached along edges, including a mesh coverage configured as non-expandable and/or non-encompassing tissue scaffolding to reduce prolapse/restenosis and to prevent migration. The device is delivered using a catheter mechanism that winds down and then expands the device with accurate placement, and tunable coil tapering is described via coil parameters and link spacing, including a step-wise tapering diameter capability.
Claims Coverage
The independent claim coverage centers on a lumen-placed device built from multiple reversing-sense helical coil segments whose connected structures create cross-over points, fill divergence gaps, and exert force on the lumen wall. Across the dependent claims, the coverage adds inventive features related to drug release, optional coverings, variable diameter along length, and delivery-system implementation details.
Reversing-sense helical-coil segments with winding-sense changing first structure
A device for placement in a lumen comprising a plurality of segments, each segment including a first helical coil and a second helical coil of opposing winding sense, where each segment is connected to another segment by a first structure that changes the winding sense of adjacent segments.
Cross-over point overlapping joined coil ends
Each first structure comprises a cross-over point comprising an end of one of the first helical coils overlapping an end of the second helical coils, wherein the end of the first helical coil and the end of the second helical coil are joined.
Filling divergence gaps and exerting force on the lumen wall
Each first structure extends into and fills a gap created by the divergence of the segments connected to each first structure, and wherein each first structure pushes the end of the first helical coil and the end of the second helical coil against a wall of the lumen and exerts force on the lumen.
Drug-loaded segments with drug release into the lumen or lumen wall
One or more drugs are contained in the plurality of segments and are configured to be released either into the lumen or into the lumen wall.
Optional covering for the device
A covering is provided and is made from a mesh, sheet, cloth, foam, or film.
Diameter changing along the device length
The device is configured so that its diameter changes along its length.
System delivery with mechanical delivery mechanism
A system further defined such that its delivery means includes a mechanical delivery mechanism.
Overall, the claims cover a lumen-placed device made of multiple segments with opposing winding sense helical coils whose connected first structures include cross-over points that are joined at overlapping coil ends, fill divergence gaps, and push against the lumen wall to exert force. Dependent claim coverage further adds drug release options, an optional covering material set, a diameter that changes along length, and a system delivery configuration that can include a mechanical delivery mechanism.
Stated Advantages
Improved retention/anchoring behavior by exerting force on the lumen wall to hold the device in place within the lumen.
Support for reducing prolapse/restenosis and preventing migration via non-expandable and/or non-encompassing mesh coverage.
Enhanced flexibility, high radial force, and crush resistance are stated in the disclosed content.
Documented Applications
Intraluminal placement of a medical device in a lumen.
Stents and stent grafts.
Anchors including vena cava filter anchors and catheter anchors.
A-V shunt anchor.
Vaso-occlusive device.
Airway and airway-related stents (tracheal/bronchial stent).
Biliary system.
Urinary tract and ureter.
Esophagus.
Crohn's disease.
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