Devices and methods for delivery of bioactive agents
Inventors
Chappa, Ralph A. • Bach, Andrew G.
Assignees
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Publication Number
US-11027049-B2
Publication Date
2021-06-08
Expiration Date
Abstract
Embodiments of the invention include bioactive agent eluting devices. In an embodiment the invention includes a bioactive agent delivery device including a substrate, a hydrophilic polymer disposed on the substrate, and a substantially amorphous bioactive agent disposed on the surface of the hydrophilic polymer. In an embodiment, the invention includes a method of making a bioactive agent delivery device including depositing a hydrophilic polymer on a substrate forming a hydrophilic surface and depositing a substantially amorphous bioactive agent on the hydrophilic surface. In an embodiment, the invention includes a bioactive agent-eluting catheter including a catheter shaft and an expandable balloon disposed on the catheter shaft. Other embodiments are included herein.
Core Innovation
The invention relates to a bioactive agent eluting device having a substrate with a hydrophilic polymer layer disposed over the substrate, where the hydrophilic polymer layer comprises a hydrophilic polymer comprising poly(ethylene glycol). Disposed over the surface of the hydrophilic polymer layer is a hydrophobic bioactive agent composition layer comprising one or more forms of paclitaxel, and the hydrophobic bioactive agent composition layer lacks the hydrophilic polymer.
The invention further addresses forming and attaching the hydrophilic polymer layer and the bioactive agent layer while maintaining separation from the hydrophilic polymer. Covalently bonded hydrophilic layers are formed using photo-polymers with latent photoreactive groups and actinic radiation to create covalent bonding, and the amorphous bioactive agent layer is formed using deposition solvents that do not solvate the hydrophilic polymer to prevent interpenetrating networks.
In balloon catheter implementations, the invention provides an expandable balloon comprising an expandable substrate with a hydrophilic basecoat and an amorphous topcoat positioned on the hydrophilic surface. Example results show increased transfer of amorphous paclitaxel from balloons to simulated and ex vivo vessel models, where transfer depends on hydrophilic basecoat composition and solvent effects.
Claims Coverage
Two independent claims define the core delivery structures, with two main inventive aspects: an expandable balloon/catheter architecture using a hydrophilic poly(ethylene glycol)-containing layer and a separate hydrophobic paclitaxel layer that lacks the hydrophilic polymer, plus dependent refinements specifying covalent attachment via latent photoreactive groups and quantitative performance/structural constraints including paclitaxel forms, solvent behavior, release timing, and substrate thickness.
Hydrophilic poly(ethylene glycol) layer with hydrophobic paclitaxel layer lacking hydrophilic polymer
A bioactive agent delivery device comprising an expandable substrate forming part of a balloon; a hydrophilic polymer layer disposed over the substrate, the hydrophilic polymer layer comprising a hydrophilic polymer comprising poly(ethylene glycol); and a hydrophobic bioactive agent composition layer disposed over the surface of the hydrophilic polymer layer, the hydrophobic bioactive composition layer comprising one or more forms of paclitaxel, wherein the hydrophobic bioactive agent composition layer lacks the hydrophilic polymer.
Catheter with expandable balloon substrate coated with hydrophilic poly(ethylene glycol) layer and hydrophobic paclitaxel layer lacking hydrophilic polymer
A bioactive agent-eluting catheter comprising a catheter shaft; an expandable balloon disposed on the catheter shaft, the expandable balloon comprising an expandable substrate; and a hydrophilic polymer layer disposed over the substrate, the hydrophilic polymer layer comprising a hydrophilic polymer comprising poly(ethylene glycol); a hydrophobic bioactive agent composition layer disposed over the surface of the hydrophilic polymer layer, the hydrophobic bioactive composition layer comprising one or more forms of paclitaxel; and wherein the hydrophobic bioactive agent composition layer lacks the hydrophilic polymer.
Across the independent claims, the inventive coverage centers on a hydrophilic poly(ethylene glycol)-containing layer and a separately disposed hydrophobic paclitaxel composition layer that lacks the hydrophilic polymer, implemented for an expandable balloon and a catheter balloon. Dependent features further specify attachment via latent photoreactive group covalent bonding, paclitaxel solid-state forms, solvent constraints that do not solvate the hydrophilic polymer, an aqueous release performance threshold, and an expandable substrate thickness range.
Stated Advantages
Increased transfer of amorphous paclitaxel from balloons to simulated and ex vivo vessel models.
Documented Applications
Balloon catheter delivery of paclitaxel, including transfer testing in simulated vessel and ex vivo porcine artery models.
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