Devices and methods for delivery of bioactive agents
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.
1. 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; and
wherein the hydrophobic bioactive agent composition layer lacks the hydrophilic polymer.
2. The bioactive agent delivery device of claim 1 , the bioactive agent composition comprising trace amounts of a solvent that does not solvate the hydrophilic polymer layer.
3. The bioactive agent delivery device of claim 1 , further comprising a catheter shaft, wherein the expandable substrate forming part of the balloon is disposed on the catheter shaft.
4. The bioactive agent delivery device of claim 1 , wherein the hydrophilic polymer layer is covalently bonded to the expandable substrate through the reaction product of a latent photoreactive group.
5. The bioactive agent delivery device of claim 1 , the expandable substrate comprising an elastomeric material.
6. The bioactive agent delivery device of claim 1 , the expandable substrate comprising a polyamide.
7. The bioactive agent delivery device of claim 1 , wherein the thickness of the expandable substrate is from 5 μm to 100 μm.
8. The bioactive agent delivery device of claim 1 , wherein the hydrophilic polymer layer is cross-linked through the reaction product of a latent photoreactive group.
9. The bioactive agent delivery device of claim 1 , wherein the paclitaxel releases from the device into an aqueous environment in under 30 seconds when exposed to an aqueous environment.
10. The bioactive agent delivery device of claim 1 , wherein the paclitaxel is present in the hydrophobic bioactive composition layer in crystalline and amorphous forms.
11. 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.
12. The bioactive agent-eluting catheter of claim 11 , wherein the paclitaxel is present in the hydrophobic bioactive composition layer in crystalline and amorphous forms.
13. The bioactive agent-eluting catheter of claim 11 , wherein the paclitaxel releases from the device into an aqueous environment in under 30 seconds when exposed to an aqueous environment.