# US 11,027,049 B2 · Devices and methods for delivery of bioactive agents

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- Number: US 11,027,049 B2
- Document ID: US11027049B2
- Status: Granted
- Kind: B2
- Application number: 15/994,263
- Filed: 2018-05-31
- Published: 2018-09-27
- Granted: 2021-06-08
- Earliest claimed: 2009-04-28
- Assignees: SurModics, Inc.
- Applicants: Surmodics, Inc.
- Inventors: Ralph A. Chappa; Andrew G. Bach
- Web page: https://patentgrep.com/patent/US11027049B2

## CPC

- A61L 29/085: {Macromolecular materials}
- A61L 29/16: Biologically active materials, e.g. therapeutic substances {(A61L29/048 takes precedence)}
- A61P 35/00: Antineoplastic agents
- A61P 37/06: Immunosuppressants, e.g. drugs for graft rejection
- A61P 43/00: Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00
- A61L 2300/416: Anti-neoplastic or anti-proliferative or anti-restenosis or anti-angiogenic agents, e.g. paclitaxel, sirolimus
- A61L 2300/60: characterised by a special physical form
- A61L: METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES (preservation of bodies or disinfecting characterised by the agents employed A01N; preserving, e.g. sterilising, food or foodstuffs A23; preparations for medical, dental or toiletry purposes A61K)
- A61P: SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS

## 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.

## Claims

### Claim 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.

### Claim 2 (depends on 1)

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.

### Claim 3 (depends on 1)

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.

### Claim 4 (depends on 1)

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.

### Claim 5 (depends on 1)

The bioactive agent delivery device of claim 1, the expandable substrate comprising an elastomeric material.

### Claim 6 (depends on 1)

The bioactive agent delivery device of claim 1, the expandable substrate comprising a polyamide.

### Claim 7 (depends on 1)

The bioactive agent delivery device of claim 1, wherein the thickness of the expandable substrate is from 5 μm to 100 μm.

### Claim 8 (depends on 1)

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.

### Claim 9 (depends on 1)

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.

### Claim 10 (depends on 1)

The bioactive agent delivery device of claim 1, wherein the paclitaxel is present in the hydrophobic bioactive composition layer in crystalline and amorphous forms.

### Claim 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.

### Claim 12 (depends on 11)

The bioactive agent-eluting catheter of claim 11, wherein the paclitaxel is present in the hydrophobic bioactive composition layer in crystalline and amorphous forms.

### Claim 13 (depends on 11)

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.