Use of nanocrystals for drug delivery from a balloon

• US 10,369,256 B2
• Filed: 06/14/2010
• Issued: 08/06/2019
• Est. Priority Date: 07/10/2009
• Status: Active Grant

• Current Assignee: Boston Scientific Scimed (Boston Scientific Corporation)
• Original Assignee: Boston Scientific Scimed (Boston Scientific Corporation)
• Inventors: Flanagan, Aiden, Weber, Jan, Clarke, John
• Primary Examiner(s): Young, Micah Paul
• Application Number:
  US12/815,158
• Publication Number:
  US 20110008260A1
• Time in Patent Office: 3,340 Days
• Field of Search: 424489, 424448, 424465
• CPC Class Codes: A61L 2300/416 Anti-neoplastic or anti-proliferative or anti-restenosis or anti-angiogenic agents, e.g. paclitaxel, sirolimus
• CPC Class Codes: A61L 2300/624 Nanocapsules
• CPC Class Codes: A61L 2300/63 Crystals
• CPC Class Codes: A61L 29/16 Biologically active materials, e.g. therapeutic substances A61L29/048 takes precedence
• CPC Class Codes: A61P 35/00 Antineoplastic agents

Abstract

A drug delivery balloon (10) has a drug thereon in the form of crystalline particles (12), the drug having a predetermined size distribution. Optionally marker particles (14, 16) are also provided. A texturized coating (18), a cap layer (20) and/or other methods may be used to increase particle loading capacity of the balloon.

Claims

1. A drug delivery balloon adapted for delivery of a drug to a site in a body passageway, the balloon comprising a balloon wall with an outer surface, and the balloon having a drug disposed on the outer surface, wherein the drug includes a plurality of crystalline drug particles provided directly on and contacting an outer surface of the balloon, wherein the crystalline drug particles comprise paclitaxel, the crystalline drug particles having a predetermined size distribution, wherein said size distribution is in a range of from 0.01 μ

m to 0.1 μ

m, wherein the crystalline drug particles are present in mixture with a water soluble excipient material, wherein the water soluble excipient material forms a fibrous matrix holding the crystalline drug particles, wherein a plurality of non-radioactive tracer particles are mixed with the crystalline drug particles, wherein the non-radioactive tracer particles are detectable by one or more of X-Ray, magnetic resonance imaging, or ultrasound.

2. A drug delivery balloon as in claim 1 wherein said crystalline drug particles comprise at least 95% by weight of said drug.

3. A drug delivery balloon as in claim 2 wherein said crystalline drug particles comprise an anti-agglomeration agent in an amount of less than 1% by weight.

4. A drug delivery balloon as in claim 1 wherein the tracer particles are admixed with drug particles on the balloon.

5. A drug delivery balloon as in claim 4 wherein said tracer particles are of similar size distribution and in a predetermined ratio whereby the amount of drug delivered to the site can be estimated on the basis of detection of the tracer particles.

6. A drug delivery balloon as in claim 4 comprising a plurality of different tracer particles that differ in the manner that they are detectable.

7. A drug delivery balloon as in claim 1 wherein said excipient is a member of the group consisting of water soluble polymers, sugars, polysaccharides, contrast agents, citrate esters, and pharmaceutically acceptable salts.

8. A drug delivery balloon as in claim 1 wherein the balloon comprises textured surface that provides increased particle retention.

9. A drug delivery balloon as in claim 1 wherein the balloon has a capping layer over crystalline drug particles that is water soluble and biodegradable and that breaks free from the balloon upon balloon expansion.

10. A drug delivery balloon as in claim 1 having an amount of crystalline dihydrate paclitaxel on the balloon of from 50 to 1000 μ

g.

11. A drug delivery balloon comprising a coating thereon and a drug applied over the coating, wherein the coating has a textured surface that increases the drug carrying capacity of the balloon, wherein the drug is provided as crystalline particles free from a polymeric material along an outer surface of the crystalline particles, the crystalline particles are held in a fibrous matrix defined by a water soluble excipient material, wherein the crystalline particles having a predetermined size distribution in a range of from 0.01 μ

m to 0.1 μ

m, wherein a plurality of non-radioactive tracer particles are mixed with the crystalline particles.

12. A drug delivery balloon as in claim 11 wherein said coating is formed of a soft silicone or urethane material.