# US 11,439,801 B2 · Balloon catheters for body lumens > Agents: this data is available as JSON from the patentgrep API and MCP server — see https://patentgrep.com/llms.txt - Number: US 11,439,801 B2 - Document ID: US11439801B2 - Status: Granted - Kind: B2 - Application number: 17/108,517 - Filed: 2020-12-01 - Published: 2021-04-22 - Granted: 2022-09-13 - Earliest claimed: 2012-10-26 - Assignees: Urotronic, Inc. - Applicants: Urotronic, Inc. - Inventors: Lixiao Wang; Peter Barnett - Web page: https://patentgrep.com/patent/US11439801B2 ## CPC - A61M 29/02: Dilators made of swellable material {(balloon catheters for angioplasty A61M25/104)} - A61L 29/16: Biologically active materials, e.g. therapeutic substances {(A61L29/048 takes precedence)} - 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}) - A61M 25/1002: {characterised by balloon shape (A61M25/1006, A61M25/1009 take precedence)} - A61K 31/337: having four-membered rings, e.g. taxol - A61L 29/08: Materials for coatings - A61L 2300/41: Anti-inflammatory agents, e.g. NSAIDs - A61L 2300/602: Type of release, e.g. controlled, sustained, slow - A61L 2300/606: Coatings - A61L 2300/802: Additives, excipients, e.g. cyclodextrins, fatty acids, surfactants - A61L 2420/06: Coatings containing a mixture of two or more compounds - A61L 2430/22: for reconstruction of hollow organs, e.g. bladder, esophagus, urether, uterus - A61M 2025/0081: {Soft tip} - 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)} - 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) - 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) ## Abstract Various embodiments disclosed relate to drug-coated balloon catheters for treating strictures in body lumens and methods of using the same. A drug-coated balloon catheter for delivering a therapeutic agent to a target site of a body lumen stricture includes an elongated balloon having a main diameter. The balloon catheter includes a coating layer overlying an exterior surface of the balloon. The coating layer includes one or more water-soluble additives and an initial drug load of a therapeutic agent. ## Claims ### Claim 1 A method for treating a body lumen stricture comprising a gastrointestinal stricture, the method comprising: flushing the body lumen stricture with a flushing media comprising water, saline solution, or a water solution comprising at least one water-soluble additive; inserting a balloon catheter into a body lumen such that the balloon catheter is in the body lumen stricture, the balloon catheter comprising an elongated balloon, the balloon comprising a coating layer overlying external balloon surfaces, the coating layer comprising at least one additive and an initial drug load of a therapeutic agent; exposing the balloon catheter to a liquid comprising the flushing media in the body lumen stricture for a soaking period prior to inflation to hydrate the coating layer; inflating the balloon catheter in the body lumen stricture to contact walls of the body lumen stricture with the coating layer and until the stricture in the body lumen is dilated to a desired diameter; deflating the balloon catheter; and withdrawing the balloon catheter from the body lumen. ### Claim 2 (depends on 1) The method of claim 1, wherein the balloon has thereon a residual drug amount after the withdrawing, wherein the residual drug amount is 70% or less of the initial drug load. ### Claim 3 (depends on 1) The method of claim 1, wherein the soaking period in combination with the contacting of the coating layer with the stricture is sufficient to release 37% to 97% of the initial drug load. ### Claim 4 (depends on 1) The method of claim 1, wherein the soaking period is predetermined prior to the exposing the balloon catheter to the liquid comprising the flushing media for the soaking period. ### Claim 5 (depends on 1) The method of claim 1, wherein the soaking period comprises at least 1 minute. ### Claim 6 (depends on 1) The method of claim 1, wherein the body lumen stricture comprises a stricture in an esophagus, biliary tract, stomach, small intestine, duodenum, jejunum, ileum, colon, rectum, large intestine, or an achalasia stricture. ### Claim 7 (depends on 1) The method of claim 1, wherein the flushing is prior to the inserting of the balloon catheter into the body lumen stricture. ### Claim 8 (depends on 1) The method of claim 1, wherein after the inflating the method further comprises keeping the balloon inflated to release the therapeutic agent into the tissue. ### Claim 9 (depends on 1) The method of claim 1, comprising keeping the balloon inflated prior to the deflating for 0.1 minutes to 10 minutes. ### Claim 10 (depends on 1) The method of claim 1, wherein the therapeutic agent comprises paclitaxel, a paclitaxel analogue, docetaxel, a docetaxel analogue, taxol, a taxol analogue, rapamycin, a rapamycin analogue, sirolimus, a sirolimus analogue, everolimus, an everolimus analogue, tacrolimus, a tacrolimus analogue, mammalian target of rapamycin (mTOR) inhibitors, an mTOR inhibitor analogue, or a combination thereof. ### Claim 11 (depends on 1) The method of claim 1, wherein a ratio by weight of the therapeutic agent to the total weight of the one or more additives in the coating layer is from 2 to 6. ### Claim 12 (depends on 1) The method of claim 1, wherein the initial drug load of the hydrophobic therapeutic agent is from 1 microgram to 20 micrograms per square millimeter of the balloon. ### Claim 13 (depends on 1) The method of claim 1, wherein the one or more additives in the coating layer comprise one or more water-soluble additives. ### Claim 14 (depends on 1) The method of claim 1, wherein the one or more additives in the coating layer comprise one or more surfactants. ### Claim 15 (depends on 14) The method of claim 14, wherein the surfactant is a nonionic, anionic, cationic, or zwitterionic surfactant, and wherein the surfactant has a molecular weight of 750 g/mol or less. ### Claim 16 (depends on 1) The method of claim 1, further comprising, prior to the step of inserting the balloon catheter, inserting an uncoated balloon catheter into the body lumen stricture; inflating the uncoated balloon catheter until the balloon contacts the walls of the body lumen stricture; deflating the uncoated balloon; and withdrawing the uncoated balloon from the body lumen. ### Claim 17 (depends on 1) The method of claim 1, wherein inflating the balloon catheter comprises inflating the balloon to at least the nominal pressure. ### Claim 18 (depends on 1) The method of claim 1, wherein the balloon catheter has a ratio of inflated balloon diameter to normative body lumen diameter at the stricture of 1.0 to 20, or the balloon catheter has a stretch ratio of the nominal balloon diameter to the normative body lumen diameter at the stricture of 1.0 to 10, or a combination thereof. ### Claim 19 (depends on 1) The method of claim 1, wherein the balloon catheter has a ratio of inflated balloon diameter to normative body lumen diameter at the stricture of 1.31 to 10, or the balloon catheter has a stretch ratio of the nominal balloon diameter to the normative body lumen diameter at the stricture of 1.31 to 10, or a combination thereof. ### Claim 20 (depends on 1) The method of claim 1, wherein the balloon catheter has a ratio of inflated balloon diameter to normative body lumen diameter at the stricture of less than 1.01, or the balloon catheter has a stretch ratio of the nominal balloon diameter to the normative body lumen diameter at the stricture of less than 1.01, or a combination thereof. ### Claim 21 (depends on 1) The method of claim 1, wherein inserting the balloon catheter into the body lumen comprises inserting the balloon catheter and a scope in the body lumen, wherein the balloon catheter and the scope are positioned side-by-side or the balloon catheter is loaded into the scope. ### Claim 22 (depends on 21) The method of claim 21, wherein the balloon catheter and the scope are positioned side-by-side. ### Claim 23 (depends on 21) The method of claim 21, wherein the balloon catheter is loaded into the scope. ### Claim 24 (depends on 23) The method of claim 23, wherein the balloon is positioned withing a working channel of the scope prior to inserting the scope into the body lumen. ### Claim 25 (depends on 23) The method of claim 23, wherein the balloon is positioned within a working channel of the scope after inserting the scope into the body lumen. ### Claim 26 (depends on 21) The method of claim 21, wherein balloon catheter is visualizable with the scope. ### Claim 27 (depends on 21) The method of claim 21, further comprising visualizing the balloon catheter with the scope before and/or during the inflating. ### Claim 28 (depends on 21) The method of claim 21, further comprising visualizing the therapeutic agent that deposits from the balloon onto the body lumen stricture via the scope. ### Claim 29 (depends on 21) The method of claim 21, wherein the scope comprises an endoscope, enteroscope, colonoscope, sigmoidoscope, rectoscope, anoscope, rhinoscope, bronchoscope, or a cystoscope.