# US 12,594,161 B2 · Systems and methods for predictable commissural alignment of a replacement heart valve > Agents: this data is available as JSON from the patentgrep API and MCP server — see https://patentgrep.com/llms.txt - Number: US 12,594,161 B2 - Document ID: US12594161B2 - Status: Granted - Kind: B2 - Application number: 18/393,475 - Filed: 2023-12-21 - Published: 2024-04-18 - Granted: 2026-04-07 - Earliest claimed: 2021-07-12 - Assignees: Anteris Technologies Corporation - Applicants: Anteris Technologies Corporation - Inventors: Jason L. Quill; Dannah Dean; Cameron James Albin Murto; Edward James Anderson; Brad James Traeger; Payton Kristine Parmett; Nicholas Weldon Pensa; Joseph Allen Duerr - Web page: https://patentgrep.com/patent/US12594161B2 ## CPC - A61F 2/2433: {using balloon catheter} - A61F 2/2418: {Scaffolds therefor, e.g. support stents} - 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 2/9517: {handle assemblies therefor} - A61F 2/958: Inflatable balloons for placing stents or stent-grafts - A61F 2250/0097: Visible markings, e.g. indicia - A61F 2250/0098: radio-opaque, e.g. radio-opaque markers - A61M 2025/1075: {having a balloon composed of several layers, e.g. by coating or embedding} - A61M 2025/1079: {having radio-opaque markers in the region of the balloon} - A61M 2205/0216: Materials providing elastic properties, e.g. for facilitating deformation and avoid breaking - 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) - 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)} ## Abstract A replacement heart valve prosthesis is loaded onto a balloon mounted onto a balloon shaft of a catheter system. The balloon shaft is rotatably engaged with an actuator on the handle of the catheter system. Rotation of the actuator by a first amount in a first direction permits rotation of the heart valve prosthesis by a known amount during the procedure so that alignment of the commissures of the replacement valve with the commissures of the existing valve can be predictably achieved. ## Claims ### Claim 1 A transcatheter prosthetic heart valve delivery system comprising: a balloon shaft; a balloon mounted onto the balloon shaft, the balloon having a delivery diameter, the balloon in fluid communication with a fluid source for expansion of the balloon from the delivery diameter to a deployed diameter; and a handle comprising an actuator engaged with the balloon shaft, wherein rotation of the actuator by an actuator rotation amount in a first direction predictably rotates the balloon in the first direction by a balloon rotation amount that is proportional to the actuator rotation amount. ### Claim 2 (depends on 1) The transcatheter prosthetic heart valve delivery system of claim 1, wherein a ratio of the actuator rotation amount to the balloon rotation amount is 1:1. ### Claim 3 (depends on 1) The transcatheter prosthetic heart valve delivery system of claim 1, further comprising a valve prosthesis loaded onto the balloon wherein the valve prosthesis comprises a valve construct attached to a frame. ### Claim 4 (depends on 3) The transcatheter prosthetic heart valve delivery system of claim 3, wherein the valve construct comprises a sutureless single-piece three-dimensional structure with three leaflets molded into the sutureless single-piece three-dimensional structure. ### Claim 5 (depends on 3) The transcatheter prosthetic heart valve delivery system of claim 3, wherein the frame includes at least one radiopaque marker. ### Claim 6 (depends on 5) The transcatheter prosthetic heart valve delivery system of claim 5, wherein the at least one radiopaque marker is positioned on a commissural post of the frame. ### Claim 7 (depends on 6) The transcatheter prosthetic heart valve delivery system of claim 6, wherein the at least one radiopaque marker is positioned onto at least one of a node or a strut adjacent to the commissural post. ### Claim 8 (depends on 1) The transcatheter prosthetic heart valve delivery system of claim 1, wherein the handle further comprises at least one actuator stop. ### Claim 9 (depends on 1) The transcatheter prosthetic heart valve delivery system of claim 1, wherein the handle further comprises a locking member, wherein when the locking member is engaged with the actuator, the balloon shaft cannot rotate. ### Claim 10 (depends on 1) The transcatheter prosthetic heart valve delivery system of claim 1, wherein the actuator is rotatable in the first direction and in a second direction opposite the first direction. ### Claim 11 A prosthetic heart valve transcatheter delivery system comprising: an inner shaft; a balloon coupled to a distal end portion of the inner shaft; an outer shaft; and a lock having a locked position and an unlocked position, wherein rotation of the inner shaft by a shaft rotation amount in a first direction predictably rotates the balloon in the first direction by a balloon rotation amount that is proportional to the shaft rotation amount, and wherein, when the lock is in the locked position, axial movement of the inner shaft and balloon relative to the outer shaft is prevented. ### Claim 12 (depends on 11) The prosthetic heart valve transcatheter delivery system of claim 11, further comprising a handle with a locking switch that engages the lock into the locked position. ### Claim 13 (depends on 12) The prosthetic heart valve transcatheter delivery system of claim 12, wherein the locking switch disengages the lock from the locked position into the unlocked position. ### Claim 14 (depends on 11) The prosthetic heart valve transcatheter delivery system of claim 11, wherein in the locked position, the inner shaft can be rotated in the first direction. ### Claim 15 (depends on 14) The prosthetic heart valve transcatheter delivery system of claim 14, wherein in the locked position, the inner shaft can be rotated in a second direction. ### Claim 16 (depends on 11) The prosthetic heart valve transcatheter delivery system of claim 11, wherein in the unlocked position, the inner shaft can move in an axial direction relative to the outer shaft and the inner shaft can be rotated in at least the first direction. ### Claim 17 (depends on 11) The prosthetic heart valve transcatheter delivery system of claim 11, wherein the inner shaft is a braided shaft. ### Claim 18 (depends on 11) The prosthetic heart valve transcatheter delivery system of claim 11, further comprising a valve prosthesis comprising at least one alignment marker. ### Claim 19 (depends on 18) The prosthetic heart valve transcatheter delivery system of claim 18, wherein the valve prosthesis comprises at least three alignment markers. ### Claim 20 (depends on 18) The prosthetic heart valve transcatheter delivery system of claim 18, wherein the at least one alignment marker comprises two overlapping serpentine struts forming a numeral 8 shape defining two openings containing radiopaque markers.