Drug-eluting medical implants
Inventors
Palasis, Maria • You, Changcheng • Concagh, Danny • Core, Lee • Ho, Kicherl • Sharma, Upma • Zugates, Gregory T
Assignees
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Abstract
Disclosed are self-expanding medical implants for placement within a lumen of a patient. The implants comprise a woven or non-woven structure having a substantially tubular configuration, and are designed to be low-profile such that they are deliverable with a small diameter catheter. The implants have a high recoverability and desired mechanical properties.
Core Innovation
The invention describes implants formed from polymeric strands or monofilaments that contain a therapeutic agent and salt, with at least part of the strands or monofilaments covered by an elastomeric polymeric coating or crosslinked thermoset elastomer. In some claims, the coating conforms to the shape of individual strands and, when compressed, applies a force in favor of radial expansion; another claim describes a conforming coating that does not cover the implant framework.
The supplied partial content reports that conformal elastomeric support coatings improve radial strength and diameter recovery, and that salts can strengthen strands and neutralize acidic degradation products. It also describes paclitaxel elution and sheep study outcomes. The supplied content does not include the background section, so the problem being solved from that section is not explicitly described in patent.
Claims Coverage
The five independent claims cover three implant configurations and two methods of delivering an implant to a body lumen.
Therapeutic-agent strands with a radial-expansion coating
An implant has a therapeutic agent contained within one or more polymeric strands and a salt incorporated within at least one strand. An elastomeric polymeric coating at least partially coats the strands, conforms to the shape of the individual strands, and, when compressed, applies a force in favor of radial expansion.
Monofilaments coated with a crosslinked thermoset elastomer
An implant structure comprises one or more polymeric monofilaments and a salt, with a thermoset elastomer comprising crosslinks at least partially coating the monofilaments.
Delivery of a therapeutic-agent implant with an elastomeric coating
The method provides an implant with a therapeutic agent and salt in one or more polymeric strands, at least partially coated by an elastomeric polymeric coating that conforms to the individual strands and, when compressed, applies a force in favor of radial expansion. The implant is placed in contact with a lumen of a body such that the therapeutic agent is eluted over time.
Delivery of a therapeutic-agent implant with a crosslinked thermoset coating
The method provides an implant comprising one or more polymeric monofilaments, a therapeutic agent, and a salt, with a crosslinked thermoset elastomer at least partially coating the monofilaments. The implant is placed in contact with a lumen of a body such that the therapeutic agent is eluted over time.
Framework of polymeric strands with a conforming coating
An implant has a framework made up of individual polymeric strands, a therapeutic agent contained within the strands, and a salt incorporated within at least one strand. An elastomeric polymeric coating conforms to the shape of the individual strands and does not cover the implant framework.
The independent claims cover implants that combine polymeric strands or monofilaments, therapeutic agents and salts, with elastomeric or crosslinked thermoset coatings; they also cover methods of placing such implants in contact with a body lumen for therapeutic-agent elution over time.
Stated Advantages
The elastomeric support coatings improve radial strength and diameter recovery.
Salts can strengthen polymeric strands and neutralize acidic degradation products.
Documented Applications
The implant is adapted for placement in a subject’s lumen. The delivery claims describe placing the implant in contact with a body lumen so that the therapeutic agent is eluted over time.
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