# US 2014/0190630 A1 · Method for Forming Catheter Balloon > Agents: this data is available as JSON from the patentgrep API and MCP server — see https://patentgrep.com/llms.txt - Number: US 2014/0190630 A1 - Document ID: US20140190630A1 - Status: Published application - Kind: A1 - Application number: 14/204,885 - Filed: 2014-03-11 - Published: 2014-07-10 - Earliest claimed: 2010-09-14 - Assignees: Abbott Cardiovascular Systems Inc. - Applicants: Abbott Cardiovascular Systems Inc. - Inventors: John A. Simpson; Sarah A. Nelson; Jonathan P. Durcan - Web page: https://patentgrep.com/patent/US20140190630A1 ## CPC - A61M 25/1029: {Production methods of the balloon members, e.g. blow-moulding, extruding, deposition or by wrapping a plurality of layers of balloon material around a mandril} - A61F 2/958: Inflatable balloons for placing stents or stent-grafts - A61L 29/04: Macromolecular materials - A61L 29/06: obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds - A61L 29/14: Materials characterised by their function or physical properties {, e.g. lubricating compositions} - A61M 25/0009: {Making of catheters or other medical or surgical tubes} - 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 25/1027: {Making of balloon catheters} - A61M 25/104: {used for angioplasty} - B29C 49/0411: {Means for defining the wall or layer thickness} - B29C 49/18: using several blowing steps (B29C49/16 takes precedence) - B29C 49/22: using multilayered preforms or parisons - A61L 2420/08: Coatings comprising two or more layers - A61M 2025/1075: {having a balloon composed of several layers, e.g. by coating or embedding} - B29L 2031/7543: {Balloon catheters} - Y10T 428/1334: Nonself-supporting tubular film or bag [e.g., pouch, envelope, packet, etc.] - Y10T 428/1352: Polymer or resin containing [i.e., natural or synthetic] - Y10T 428/1386: Natural or synthetic rubber or rubber-like compound containing - Y10T 428/1393: Multilayer [continuous layer] - 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) - 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) - B29C: SHAPING OR JOINING OF PLASTICS; SHAPING OF MATERIAL IN A PLASTIC STATE, NOT OTHERWISE PROVIDED FOR; AFTER-TREATMENT OF THE SHAPED PRODUCTS, e.g. REPAIRING (making preforms B29B11/00; making laminated products by combining previously unconnected layers which become one product whose layers will remain together B32B37/00 - B32B41/00) - B29L: INDEXING SCHEME ASSOCIATED WITH SUBCLASS B29C, RELATING TO PARTICULAR ARTICLES - Y10T: TECHNICAL SUBJECTS COVERED BY FORMER US CLASSIFICATION ## Abstract Method of making a balloon catheter includes providing an elongated shaft having a proximal end and a distal end and an inflation lumen extending therein, providing a multilayer tube, forming a multilayer balloon by blow-molding the multilayer tube such that the multilayer balloon is blown, in at least a first stage, to a final working radial dimension, and securing the multilayer balloon on a distal section of the shaft with an interior of the multilayer balloon in fluid communication with the inflation lumen. The ADDR of the multilayer balloon after formation is approximately 2.0. ## Claims ### Claim 1 A method of making a balloon catheter comprising: a) providing an elongated shaft having a proximal end and a distal end and an inflation lumen extending therein; b) providing a multilayer tube comprising a first layer of a first elastomeric polymeric material and a second layer of a second elastomeric polymeric material, the second elastomeric polymeric material having a lower maximum blow up ratio (BUR) than the first elastomeric polymeric material, and the multilayer tube having an inner diameter and an outer diameter, wherein the second layer is an outer layer relative to the first layer; c) forming a multilayer balloon by blow-molding the multilayer tube such that the multilayer balloon is blown, in at least a first stage, to a final working radial dimension, and further wherein the ADDR of the multilayer balloon after formation is approximately 2.0; and d) securing the multilayer balloon on a distal section of the shaft with an interior of the multilayer balloon in fluid communication with the inflation lumen. ### Claim 2 (depends on 1) The method of claim 1, wherein the second elastomeric polymeric material has a Shore durometer hardness greater than a Shore durometer hardness of the first elastomeric polymer material. ### Claim 3 (depends on 1) The method of claim 1, wherein the multilayer tube is formed by coextrusion. ### Claim 4 (depends on 1) The method of claim 1, wherein the first layer is bonded to the second layer with a tie layer. ### Claim 5 (depends on 1) The method of claim 1, wherein the balloon catheter is a stent delivery catheter, and further wherein an expandable stent is mounted on the multilayer balloon for delivery and deployment within a patient's body lumen. ### Claim 6 (depends on 1) The method of claim 1, wherein the multilayer balloon is blown in the first stage to a first radial dimension, and further wherein the multilayer balloon is blown in a subsequent stage to the final working radial dimension. ### Claim 7 (depends on 1) The method of claim 1, further comprising heating the balloon to at least 100° C. for about fifteen to about sixty minutes after blow-molding. ### Claim 8 (depends on 1) The method of claim 1, wherein the multilayer balloon is blown in the first stage to the final working radial dimension such that axial deformation of the multilayer balloon is near an axial deformation limit of the multilayer balloon, further wherein the multilayer balloon is heat set at a temperature above 100° C. after blow molding. ### Claim 9 (depends on 8) The method of claim 8, wherein the multilayer balloon is heat set for about 15 to about 60 minutes. ### Claim 10 (depends on 8) The method of claim 8, wherein the second layer has a Shore durometer hardness greater than a Shore durometer hardness of the first layer. ### Claim 11 (depends on 8) The method of claim 8, wherein the first layer is bonded to the second layer with a tie layer. ### Claim 12 (depends on 8) The method of claim 8, wherein the balloon catheter is a stent delivery catheter, and further wherein an expandable stent is mounted on the multilayer balloon for delivery and deployment within a patient's body lumen. ### Claim 13 (depends on 1) The method of claim 1, wherein the multilayer balloon has an average blow up ratio (BUR) greater than that of a multilayer balloon having a first layer of the first elastomeric polymeric material and a second outer layer of the second elastomeric polymeric material and an area draw-down ratio (ADDR) near 3. ### Claim 14 (depends on 13) The method of claim 13, wherein the average blow up ratio is an integrated average blow up ratio. ### Claim 15 (depends on 1) The method of claim 1, wherein the multilayer balloon has a circumferential orientation throughout a balloon wall greater than that of a multilayer balloon having a first layer of the first elastomeric polymeric material and a second outer layer of the second elastomeric polymeric material and an area draw-down ratio (ADDR) near 3. ### Claim 16 (depends on 1) The method of claim 1, wherein the multilayer balloon has a compliance less than that of a multilayer balloon having a first layer of the first elastomeric polymeric material and a second outer layer of the second elastomeric polymeric material and an area draw-down ratio (ADDR) near 3. ### Claim 17 (depends on 1) The method of claim 1, wherein the multilayer balloon has a rupture strength greater than that of a multilayer balloon having a first layer of the first elastomeric polymeric material and a second outer layer of the second elastomeric polymeric material and an area draw-down ratio (ADDR) near 3. ### Claim 18 (depends on 1) The method of claim 1, wherein the multilayer balloon is formed by blowing molding an extruded tube, the extruded tube having an elongation to failure between about 125% and about 150%.