# US 2016/0250453 A1 · Drug releasing coatings for balloon catheters > Agents: this data is available as JSON from the patentgrep API and MCP server — see https://patentgrep.com/llms.txt - Number: US 2016/0250453 A1 - Document ID: US20160250453A1 - Status: Published application - Kind: A1 - Application number: 15/154,669 - Filed: 2016-05-13 - Published: 2016-09-01 - Earliest claimed: 2006-11-20 - Assignees: Lutonix, Inc. - Applicants: Lutonix, Inc. - Inventors: Lixiao Wang - Web page: https://patentgrep.com/patent/US20160250453A1 ## CPC - A61M 25/10: Balloon catheters ({A61M25/0125 takes precedence; embolectomy A61B17/22032; retractors A61B17/02;} inflatable balloons for placing stents or stent-grafts A61F2/958 {; stomach balloons for treatment of obesity A61F5/0003; oesophagal tubes A61J15/00}) - A61F 2/844: folded prior to deployment - A61F 2/958: Inflatable balloons for placing stents or stent-grafts - A61K 31/337: having four-membered rings, e.g. taxol - A61K 31/436: the heterocyclic ring system containing a six-membered ring having oxygen as a ring hetero atom, e.g. rapamycin - A61L 29/08: Materials for coatings - A61L 29/085: {Macromolecular materials} - A61L 29/16: Biologically active materials, e.g. therapeutic substances {(A61L29/048 takes precedence)} - A61L 31/08: Materials for coatings - A61L 31/10: Macromolecular materials - A61L 31/16: Biologically active materials, e.g. therapeutic substances {(A61L31/047 takes precedence)} - A61K 2300/00: Mixtures or combinations of active ingredients, wherein at least one active ingredient is fully defined in groups A61K31/00 - A61K41/00 - A61L 2300/416: Anti-neoplastic or anti-proliferative or anti-restenosis or anti-angiogenic agents, e.g. paclitaxel, sirolimus - A61L 2300/428: Vitamins, e.g. tocopherol, riboflavin - A61L 2300/606: Coatings - A61L 2300/608: having two or more layers - A61L 2300/802: Additives, excipients, e.g. cyclodextrins, fatty acids, surfactants - A61M 2025/105: {having a balloon suitable for drug delivery, e.g. by using holes for delivery, drug coating or membranes} - A61M: DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY (introducing media into or onto the bodies of animals A61D7/00; means for inserting tampons A61F13/26; devices for administering food or medicines orally A61J; containers for collecting, storing or administering blood or medical fluids A61J1/05); DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY (surgery A61B; chemical aspects of surgical articles A61L); DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR {(Electrotherapy, e.g. producing anaesthesia by the use of alternating or intermittent currents A61N1/36021)} - A61F: FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS (dental prosthetics A61C) - A61K: PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES (devices or methods specially adapted for bringing pharmaceutical products into particular physical or administering forms A61J3/00; chemical aspects of, or use of materials for deodorisation of air, for disinfection or sterilisation, or for bandages, dressings, absorbent pads or surgical articles A61L; soap compositions C11D) - 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) ## Abstract Balloon catheters, methods for preparing balloon catheters, and uses of balloon catheters are disclosed. The balloon catheter includes an elongate member, an expandable balloon, and a coating layer overlying an exterior surface of the expandable balloon. The coating layer includes a total drug load of a hydrophobic therapeutic agent and a combination of additives including a first additive and a second additive. The hydrophobic therapeutic agent is paclitaxel, rapamycin, or paclitaxel and rapamycin. The first additive is a surfactant. The second additive is a chemical compound having one or more hydroxyl, amino, carbonyl, carboxyl, acid, amide, or ester groups. ## Claims ### Claim 1 A balloon catheter for delivering a therapeutic agent to a blood vessel while the balloon catheter is deployed at a target site of the blood vessel, the balloon catheter comprising: an elongate member having a lumen and a distal end, an expandable balloon attached to the distal end of the elongate member and in fluidic communication with the lumen; and a dried coating layer overlying an exterior surface of the expandable balloon, wherein: the dried coating layer comprises a total drug load of a hydrophobic therapeutic agent and a combination of additives comprising a first additive and a second additive; the hydrophobic therapeutic agent is one of paclitaxel, rapamycin, or combinations thereof; the first additive is one of PEG sorbitan monolaurates, PEG sorbitan monooleates, or combinations thereof; and the second additive is one of sorbitol, sorbitan, xylitol, gluconolactone, lactobionic acid, or combinations thereof. ### Claim 2 (depends on 1) The balloon catheter of claim 1, wherein the hydrophobic therapeutic agent is paclitaxel. ### Claim 3 (depends on 1) The balloon catheter of claim 1, wherein the hydrophobic therapeutic agent is rapamycin. ### Claim 4 (depends on 1) The balloon catheter of claim 1, wherein the hydrophobic therapeutic agent is uniformly distributed in the dried coating layer. ### Claim 5 (depends on 1) The balloon catheter of claim 1, wherein the total drug load of the hydrophobic therapeutic agent is from 1 μg to 20 μg per square millimeter of the expandable balloon. ### Claim 6 (depends on 1) The balloon catheter of claim 1, wherein the total drug load of the hydrophobic therapeutic agent is from 2.5 μg to 6 μg per square millimeter of the expandable balloon. ### Claim 7 (depends on 1) The balloon catheter of claim 1, wherein the first additive is a PEG sorbitan monolaurate. ### Claim 8 (depends on 7) The balloon catheter of claim 7, wherein the PEG sorbitan monolaurate is PEG-20 sorbitan monolaurate. ### Claim 9 (depends on 1) The balloon catheter of claim 1, wherein the first additive is a PEG sorbitan monooleate. ### Claim 10 (depends on 9) The balloon catheter of claim 9, wherein the PEG sorbitan monooleate is PEG-20 sorbitan monooleate. ### Claim 11 (depends on 1) The balloon catheter of claim 1, wherein the first additive is one of PEG-20 sorbitan monolaurate, PEG-20 sorbitan monooleate, or combinations thereof. ### Claim 12 (depends on 1) The balloon catheter of claim 1, wherein the second additive is one of sorbitol, gluconolactone, or combinations thereof. ### Claim 13 (depends on 1) The balloon catheter of claim 1, wherein the second additive is sorbitol. ### Claim 14 (depends on 1) The balloon catheter of claim 1, wherein the second additive is gluconolactone. ### Claim 15 (depends on 1) The balloon catheter of claim 1, wherein the ratio by weight of the combination of additives in the dried coating layer to the hydrophobic therapeutic agent in the dried coating layer is about 10 to 0.5. ### Claim 16 (depends on 1) The balloon catheter of claim 1, wherein: the dried coating layer consists essentially of the hydrophobic therapeutic agent, the first additive, and the second additive; the hydrophobic therapeutic agent is paclitaxel; the first additive is one of PEG-20 sorbitan monolaurate, PEG-20 sorbitan monooleate, or combinations thereof; and the second additive is one of sorbitol, gluconolactone, or combinations thereof. ### Claim 17 (depends on 1) The balloon catheter of claim 1, wherein: the dried coating layer consists essentially of the hydrophobic therapeutic agent, the first additive, and the second additive; the hydrophobic therapeutic agent is paclitaxel; the first additive is PEG-20 sorbitan monolaurate; and the second additive is sorbitol. ### Claim 18 (depends on 1) The balloon catheter of claim 1, wherein: the dried coating layer consists essentially of the hydrophobic therapeutic agent, the first additive, and the second additive; the hydrophobic therapeutic agent is paclitaxel; the second additive is gluconolactone; and the total drug load of the hydrophobic therapeutic agent is from 2 μg to 6 μg per square millimeter of the expandable balloon. ### Claim 19 (depends on 1) The balloon catheter of claim 1, wherein the dried coating layer has a thickness of from about 0.1 μm to 15 μm. ### Claim 20 A balloon catheter for delivering a therapeutic agent to a blood vessel while the balloon catheter is deployed at a target site of the blood vessel, the balloon catheter comprising: an elongate member having a lumen and a distal end, an expandable balloon attached to the distal end of the elongate member and in fluid communication with the lumen; and a dried coating layer overlying an exterior surface of the expandable balloon, wherein: the dried coating layer comprises a total drug load of a hydrophobic therapeutic agent and a combination of additives comprising a first additive and a second additive; the total drug load of the hydrophobic therapeutic agent is from 2.5 μg to 6 μg per square millimeter of the expandable balloon; the hydrophobic therapeutic agent is one of paclitaxel, rapamycin, or combinations thereof; the first additive is one of PEG-20 sorbitan monolaurate, PEG-20 sorbitan monooleate, or combinations thereof; the second additive is one of sorbitol, gluconolactone, or combinations thereof; and the ratio by weight of the combination of additives in the dried coating layer to the hydrophobic therapeutic agent in the dried coating layer is about 10 to 0.5.