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Publication Number
US-10201639-B2
Publication Date
2019-02-12
Expiration Date
Abstract
Disclosed are medical implants for placement within a lumen of a patient. The implants comprise a polymer and drug-coated metal structure having a tubular configuration and designed to deliver the drug to target tissue at tailored linear drug elution rate.
Core Innovation
The patent describes a coated stent comprising a tubular metallic substrate, a paclitaxel-containing first biodegradable-polymer coating, and a second biodegradable-polymer coating that does not contain a therapeutic agent. Specific configurations utilize poly(L-lactide-co-caprolactone) (PLCL) and poly(L-lactide) (PLA) in both coatings, with paclitaxel incorporated in the first coating. The coating composition, thickness, paclitaxel amount, and release profile are configured to regulate paclitaxel elution.
The disclosure demonstrates cumulative paclitaxel-release profiles across multiple stent formulations, showing sustained, near-linear release for up to six months. Coating integrity is preserved after simulated deployment and catheter crimping across several stent platforms, with scanning electron micrographs illustrating coated struts and intersections. Because the background section is omitted from the disclosure, the specific problem being solved is not explicitly described in patent.
Claims Coverage
The supplied relevant independent claims cover two coated-stent configurations across two inventive features.
Biodegradable-polymer coatings on a metallic stent
The claim recites a tubular metallic substrate at least partially covered by a first coating comprising a biodegradable polymer or blend of biodegradable polymers and paclitaxel, and a second coating comprising a biodegradable polymer or blend of biodegradable polymers that does not contain a therapeutic agent. The total paclitaxel amount is 10–80 µg per 10 mm length of stent, the first coating is 1–15 microns thick, and the second coating is 1–35 microns thick.
PLCL and PLA coatings containing paclitaxel
The claim recites a tubular metallic substrate at least partially covered by a first coating comprising a blend of PLCL, PLA, and paclitaxel, and a second coating comprising PLCL and PLA without a therapeutic agent. The first coating comprises 10–99 wt percent PLCL and 1–90 wt percent PLA, and the total paclitaxel amount is 10–80 µg per 10 mm length of stent.
The independent claims cover a metallic stent having a paclitaxel-containing first coating and a therapeutic-agent-free second coating, defined either broadly as biodegradable polymers or specifically as blends of PLCL and PLA.
Stated Advantages
The coatings provide controlled, extended paclitaxel elution, with reported near-linear release for up to six months.
Coating integrity is maintained following simulated deployment and catheter crimping across several stent platforms.
Documented Applications
The coated stent is applied for delivery to a treatment site, with documented stent platforms including EverFlex, LifeStent, Absolute Pro, S.M.A.R.T., and Supera stents.
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