# US 10,369,256 B2 · Use of nanocrystals for drug delivery from a balloon > Agents: this data is available as JSON from the patentgrep API and MCP server — see https://patentgrep.com/llms.txt - Number: US 10,369,256 B2 - Document ID: US10369256B2 - Status: Granted - Kind: B2 - Application number: 12/815,158 - Filed: 2010-06-14 - Published: 2011-01-13 - Granted: 2019-08-06 - Earliest claimed: 2009-07-10 - Assignees: Boston Scientific Scimed, Inc. - Applicants: Aiden Flanagan; Jan Weber; John Clarke - Inventors: Aiden Flanagan; Jan Weber; John Clarke - Web page: https://patentgrep.com/patent/US10369256B2 ## CPC - A61L 29/16: Biologically active materials, e.g. therapeutic substances {(A61L29/048 takes precedence)} - A61P 35/00: Antineoplastic agents - A61L 2300/416: Anti-neoplastic or anti-proliferative or anti-restenosis or anti-angiogenic agents, e.g. paclitaxel, sirolimus - A61L 2300/624: Nanocapsules - A61L 2300/63: Crystals - 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 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 ### Claim 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 μm to 0.1 μm, 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. ### Claim 2 (depends on 1) A drug delivery balloon as in claim 1 wherein said crystalline drug particles comprise at least 95% by weight of said drug. ### Claim 3 (depends on 2) 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. ### Claim 4 (depends on 1) A drug delivery balloon as in claim 1 wherein the tracer particles are admixed with drug particles on the balloon. ### Claim 5 (depends on 4) 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. ### Claim 6 (depends on 4) A drug delivery balloon as in claim 4 comprising a plurality of different tracer particles that differ in the manner that they are detectable. ### Claim 7 (depends on 1) 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. ### Claim 8 (depends on 1) A drug delivery balloon as in claim 1 wherein the balloon comprises textured surface that provides increased particle retention. ### Claim 9 (depends on 1) 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. ### Claim 10 (depends on 1) A drug delivery balloon as in claim 1 having an amount of crystalline dihydrate paclitaxel on the balloon of from 50 to 1000 μg. ### Claim 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 μm to 0.1 μm, wherein a plurality of non-radioactive tracer particles are mixed with the crystalline particles. ### Claim 12 (depends on 11) A drug delivery balloon as in claim 11 wherein said coating is formed of a soft silicone or urethane material.