# US 6,296,655 B1 · Catheter balloon with biased multiple wings > Agents: this data is available as JSON from the patentgrep API and MCP server — see https://patentgrep.com/llms.txt - Number: US 6,296,655 B1 - Document ID: US6296655B1 - Status: Granted - Kind: B1 - Application number: 09/067,450 - Filed: 1998-04-27 - Granted: 2001-10-02 - Earliest claimed: 1998-04-27 - Assignees: Advanced Cardiovascular Systems, Inc. - Inventors: Henri A. Gaudoin; Philip C. Foreman; Tri-Phuoc V. Le - Web page: https://patentgrep.com/patent/US6296655B1 ## CPC - A61M 25/1038: {Wrapping or folding devices for use with balloon catheters} - A61F 2/958: Inflatable balloons for placing stents or stent-grafts - A61M 25/1002: {characterised by balloon shape (A61M25/1006, A61M25/1009 take precedence)} - A61F 2/9522: {Means for mounting a stent or stent-graft onto or into a placement instrument} - A61M 2025/1004: {Balloons with folds, e.g. folded or multifolded} - 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) ## Abstract A balloon catheter for dilating a stenotic region of a patient's body lumen such as an artery or for the implantation of an expandable stent within a patient's body lumen. The balloon of the catheter has a plurality of canted wings which are inclined at an angle of about 15° to about 75°, preferably about 30° to about 60° from a line tangent to an inner tubular member extending within the interior of the balloon. ## Claims ### Claim 1 A balloon catheter, comprising: a) an elongated shaft having proximal and distal ends, a port in the distal end, an inner tubular member defining at least in part a guidewire lumen extending to and in fluid communication with the port in the distal end and an inflation lumen extending to a location spaced proximal to the distal end; and b) an inflatable deflated balloon on a distal portion of the elongated shaft and having an interior in fluid communication with the inflation lumen and having a first unwrapped configuration and a second wrapped configuration when the balloon is wrapped around the inner tubular member, the balloon in the first unwrapped configuration having a plurality of canted wings, each of which is formed to have a base inclined at an angle of about 15° to about 75° from a line at the base of said wing tangent to an exterior surface of the inner member, the angle being measured in a cross-sectional plane which is perpendicular to the longitudinal axis of said elongated shaft, and the balloon in the second wrapped configuration having a curvilinear junction between the base of the wing and a balloon section located between the wing and an adjacent wing. ### Claim 2 (depends on 1) The catheter of claim 1 wherein the balloon has at least three canted wings. ### Claim 3 (depends on 1) The catheter of claim 1 wherein the balloon is formed of a thermoplastic polymeric material. ### Claim 4 (depends on 3) The catheter of claim 3 wherein the thermoplastic polymeric material is selected from the group consisting of polyolefins, polyesters, polyamide, polyurethanes and copolymers and blends thereof. ### Claim 5 (depends on 1) The catheter of claim 1 wherein the interior of the balloon is at a partial vacuum of about 10 to about 29 inches of Hg. ### Claim 6 (depends on 1) The catheter of claim 1 wherein the interior of the balloon is at a partial vacuum of about 20 to about 27 inches of Hg. ### Claim 7 (depends on 1) The catheter of claim 1 wherein the base of each wing of the balloon is inclined at an angle of about 30° to about 60° from the line at the base of said wing. ### Claim 8 A method of forming a low profile balloon formed of relatively non-compliant polymeric material having a plurality of wings canted at an angle comprising: a) providing a balloon having a cylindrical working section and tapered ends which define an interior chamber within the balloon and an elongated tubular inner member extending within the interior chamber of the balloon; b) inflating the balloon to a pressure of less than 20 psi; c) pressing a plurality of shaping surfaces against the exterior of the inflated balloon so as to form a plurality of wings, each wing having a base inclined at an angle of about 15° to about 75° from a line at the base of said wing tangent to an exterior surface of the inner member; d) subjecting the interior chamber of the balloon to a partial vacuum of about 10 to about 29 inches of Hg; and e) wrapping the wings about an inner member. ### Claim 9 (depends on 8) The method of claim 8 wherein at least three shaping members are pressed against the exterior of the partially inflated balloon. ### Claim 10 (depends on 8) The method of claim 8 wherein the vacuum applied within the interior of the balloon is about 20 to about 27 inches of Hg. ### Claim 11 A method of mounting a cylindrically shaped stent onto cylindrically shaped balloon on a stent delivery catheter, comprising: a) providing a stent delivery catheter having proximal and distal portions and a balloon on the distal portion having a cylindrical working section and tapered ends which define an interior chamber within the balloon and an elongated inner member extending within the interior chamber of the balloon; b) inflating the balloon to a relatively low pressure; c) pressing a plurality of shaping surfaces against the exterior of the partially inflated balloon so as to form a plurality of wings each wing having a base inclined at an angle of about 15° to about 75° from a line at the base of said wing tangent to an exterior surface of the inner member; and d) reducing the pressure within the interior chamber of the balloon to a vacuum of about 10 to about 29 inches of Hg so as to maintain the balloon wings in the desired inclined position; e) wrapping the wings about the balloon in the same directions as the wings are inclined; f) mounting a stent about the wrapped balloon; and g) crimping the stent onto the wrapped balloon. ### Claim 12 (depends on 11) The method of claim 11 wherein a vacuum of about 20 to about 27 inches of Hg is applied to the interior of the balloon. ### Claim 13 A stent delivery system, comprising: a) a catheter with an elongated shaft having proximal and distal ends, a port in the distal end, an inner tubular member defining at least in part a guidewire lumen extending to and in fluid communication with the port in the distal end and an inflation lumen extending to a location spaced proximal to the distal end, and an inflatable deflated balloon on a distal portion of the elongated shaft and having an interior in fluid communication with the inflation lumen and having a first unwrapped configuration and a second wrapped configuration when the balloon is wrapped around the inner tubular member, the balloon in the first unwrapped configuration having a plurality of canted wings, each of which is formed to have a base inclined at an angle of about 15° to about 75° from a line at the base of said wing tangent to an exterior surface of the inner member, the angle being measured in a cross-sectional plane which is perpendicular to the longitudinal axis of said elongated shaft, and the balloon in the second wrapped configuration having a curvilinear junction between the base of the wing and a balloon section located between the wing and an adjacent wing; and b) an expandable stent mounted on the exterior of the balloon. ### Claim 14 (depends on 13) The stent delivery system of claim 13 wherein a sheath is disposed between the exterior of the balloon and the stent mounted thereon. ### Claim 15 A balloon catheter comprising: a) an elongated shaft having proximal and distal ends, a port in the distal end, an inner tubular member defining at least in part a guidewire lumen extending to and in fluid communication with the port in the distal end and an inflation lumen extending to a location spaced proximal to the distal end; and b) an inflatable deflated balloon on a distal portion of the elongated shaft which has an interior in fluid communication with the inflation lumen and which has a plurality of canted wings, each of which is formed to have a base inclined at an angle of about 15° to about 75° from a line at the base of said wing tangent to an exterior surface of the inner member, the angle being measured in a cross-sectional plane which is perpendicular to the longitudinal axis of said elongated shaft, and wherein each of the wings is substantially straight as viewed in a cross-section taken perpendicular to the longitudinal axis of said elongated shaft. ### Claim 16 A stent delivery system comprising: a) a catheter with an elongated shaft having proximal and distal ends, a port in the distal end, an inner tubular member defining at least in part a guidewire lumen extending to and in fluid communication with the port in the distal end and an inflation lumen extending to a location spaced proximal to the distal end, and an inflatable deflated balloon on a distal portion of the elongated shaft which has an interior in fluid communication with the inflation lumen and which has a plurality of canted wings, each of which is formed to have a base inclined at an angle of about 15° to about 75° from a line at the base of said wing tangent to an exterior surface of the inner member, the angle being measured in a cross-sectional plane which is perpendicular to the longitudinal axis of said elongated shaft, and wherein each of the wings is substantially straight as viewed in a cross-section taken perpendicular to the longitudinal axis of said elongated shaft; and b) an expandable stent mounted on the exterior of the balloon. ### Claim 17 A balloon catheter, comprising: a) an elongated shaft having proximal and distal ends, a port in the distal end, an inner tubular member defining at least in part a guidewire lumen extending to and in fluid communication with the port in the distal end and an inflation lumen extending to a location spaced proximal to the distal end; and b) an inflatable deflated balloon on a distal portion of the elongated shaft and having an interior in fluid communication with the inflation lumen and having a first unwrapped configuration and a second wrapped configuration when the balloon is wrapped around the inner tubular member, the balloon in the first unwrapped configuration having a plurality of canted wings, each of which is formed to have a base inclined at an angle of about 15° to about 75° from a line at the base of said wing tangent to an exterior surface of the inner member, the angle being measured in a cross-sectional plane which is perpendicular to the longitudinal axis of said elongated shaft.