# US 12,178,701 B2 · Valve delivery system including foreshortening compensator for improved positioning accuracy > Agents: this data is available as JSON from the patentgrep API and MCP server — see https://patentgrep.com/llms.txt - Number: US 12,178,701 B2 - Document ID: US12178701B2 - Status: Granted - Kind: B2 - Application number: 18/181,941 - Filed: 2023-03-10 - Published: 2023-07-06 - Granted: 2024-12-31 - Earliest claimed: 2019-10-09 - Assignees: Medtronic Cv Luxembourg S.A.R.L. - Applicants: Medtronic CV Luxembourg S.a.r.l. - Inventors: Stephen Montgomery; Maro Sciacchitano - Web page: https://patentgrep.com/patent/US12178701B2 ## CPC - A61F 2/2436: {Deployment by retracting a sheath} - A61F 2/9517: {handle assemblies therefor} - A61F 2/2418: {Scaffolds therefor, e.g. support stents} - A61F 2/966: with relative longitudinal movement between outer sleeve and prosthesis, e.g. using a push rod - A61B 2017/00318: {Steering mechanisms} - A61F 2/2439: {Expansion controlled by filaments} - A61F 2002/9665: {with additional retaining means} - A61F 2210/0014: using shape memory or superelastic materials, e.g. nitinol - A61M 25/0136: {Handles therefor} - 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) - A61B: DIAGNOSIS; SURGERY; IDENTIFICATION (usefulness limited to only animals A61D) - 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 system including a self-expanding prosthesis configured to foreshorten during deployment thereof and a delivery device configured to percutaneously deliver the self-expanding prosthesis. The delivery device includes a handle having an actuator thereon, an outer sheath including a proximal end coupled to the handle and a pusher shaft slidingly disposed within the outer sheath. The pusher shaft has a proximal end coupled to the handle and a distal end configured to releasably couple to the self-expanding prosthesis such that the self-expanding prosthesis axially moves therewith. The inner shaft has a distal portion of the inner shaft that is configured to receive a self-expanding prosthesis thereon. The outer sheath and the pusher shaft are configured to simultaneously move in opposing axial directions via actuation of the actuator on the handle to compensate for the foreshortening of the self-expanding prosthesis during deployment. ## Claims ### Claim 1 A method of delivering a self-expanding heart valve prosthesis to a treatment site within the vasculature of a patient using a delivery device comprising an outer sheath, a pusher shaft slidingly disposed within the outer sheath, and an inner shaft disposed within the pusher shaft and coupled to the pusher shaft, the inner shaft comprising a distal portion which receives the self-expanding heart valve prosthesis thereon, a distal end of the distal portion of the inner shaft provided with a distal tip, the method comprising: delivering the delivery device to the treatment site such that a proximal end of the self-expanding heart valve prosthesis is positioned at an annulus of a native heart valve, wherein the distal portion of the inner shaft is disposed within the outer sheath and the distal tip engages and is distal to a distal end of the outer sheath during the step of delivering the delivery device to the treatment site; and deploying the self-expanding heart valve prosthesis at the annulus of the native heart valve via relative axial movement of the outer sheath and an assembly of the inner shaft, the self-expanding heart valve prosthesis, the distal tip and the pusher shaft such that the distal portion of the inner shaft is disposed outside of the outer sheath and the distal tip is distally spaced away from the distal end of the outer sheath after the step of deploying the self-expanding heart valve prosthesis, wherein the self-expanding heart valve prosthesis foreshortens during deployment and wherein the outer sheath is proximally retracted and the assembly is simultaneously distally advanced as the self-expanding heart valve prosthesis is deployed in order to compensate for the foreshortening of the self-expanding heart valve prosthesis. ### Claim 2 (depends on 1) The method of claim 1, wherein the distal advancement movement of the pusher shaft during the step of deploying the self-expanding heart valve prosthesis ensures that the proximal end of the self-expanding heart valve prosthesis remains positioned at the annulus during deployment. ### Claim 3 (depends on 1) The method of claim 1, wherein the self-expanding heart valve prosthesis is configured to foreshorten a first distance during deployment thereof and the pusher shaft is configured to distally advance the self-expanding heart valve prosthesis the first distance during deployment. ### Claim 4 (depends on 1) The method of claim 1, wherein the outer sheath is proximally retracted and the pusher shaft is simultaneously distally advanced at different rates, the pusher shaft being distally advanced at a rate profile that corresponds with a rate of foreshortening of the self-expanding heart valve prosthesis. ### Claim 5 (depends on 4) The method of claim 4, wherein the outer sheath moves at least 50% faster than the pusher shaft. ### Claim 6 A method of delivering a self-expanding heart valve prosthesis to a treatment site within the vasculature of a patient using a delivery device comprising an outer sheath, a pusher shaft slidingly disposed within the outer sheath, and an inner shaft disposed within the pusher shaft and coupled to the pusher shaft, the inner shaft comprising a distal portion which receives the self-expanding heart valve prosthesis thereon, a distal end of the distal portion of the inner shaft provided with a distal tip, the method comprising: delivering the delivery device to the treatment site such that a proximal end of the self-expanding heart valve prosthesis is positioned at an annulus of a native heart valve, wherein the self-expanding heart valve prosthesis is disposed within the outer sheath during delivery and the distal tip is distal to a distal end of the outer sheath during delivery; and deploying the self-expanding heart valve prosthesis at the annulus of the native heart valve via relative axial movement of the outer sheath and an assembly of the inner shaft, the self-expanding heart valve prosthesis, the distal tip and the pusher shaft such that the self-expanding heart valve prosthesis is disposed outside of the outer sheath after deployment, wherein the self-expanding heart valve prosthesis foreshortens during deployment and wherein the outer sheath is proximally retracted and the assembly of the inner shaft, the self-expanding heart valve prosthesis, the distal tip and the pusher shaft is simultaneously distally advanced as the self-expanding heart valve prosthesis is deployed in order to compensate for the foreshortening of the self-expanding heart valve prosthesis. ### Claim 7 (depends on 6) The method of claim 6, wherein the distal advancement movement of the assembly of the inner shaft, the self-expanding heart valve prosthesis, the distal tip and the pusher shaft during the step of deploying the self-expanding heart valve prosthesis ensures that the proximal end of the self-expanding heart valve prosthesis remains positioned at the annulus during deployment. ### Claim 8 (depends on 6) The method of claim 6, wherein the self-expanding heart valve prosthesis is configured to foreshorten a first distance during deployment thereof and the assembly of the inner shaft, the self-expanding heart valve prosthesis, the distal tip and the pusher shaft is configured to distally advance the self-expanding heart valve prosthesis the first distance during deployment. ### Claim 9 (depends on 6) The method of claim 6, wherein the outer sheath is proximally retracted and the assembly of the inner shaft, the self-expanding heart valve prosthesis, the distal tip and the pusher shaft is simultaneously distally advanced at different rates, the pusher shaft being distally advanced at a rate profile that corresponds with a rate of foreshortening of the self-expanding heart valve prosthesis. ### Claim 10 (depends on 9) The method of claim 9, wherein the outer sheath moves at least 50% faster than the pusher shaft. ### Claim 11 (depends on 6) The method of claim 6, wherein the distal tip engages the distal end of the outer sheath during the step of delivering the delivery device to the treatment site and wherein the distal tip is distally spaced away from the distal end of the outer sheath after the step of deploying the self-expanding prosthesis. ### Claim 12 A method of delivering a self-expanding prosthesis to a treatment site within the vasculature of a patient using a delivery device comprising an outer sheath, a pusher shaft slidingly disposed within the outer sheath, and an inner shaft disposed within the pusher shaft and coupled to the pusher shaft, the inner shaft comprising a distal portion which receives the self-expanding prosthesis thereon, a distal end of the distal portion of the inner shaft provided with a distal tip, the method comprising: delivering the delivery device to the treatment site such that a proximal end of the self-expanding prosthesis is positioned at a target location, wherein the self-expanding prosthesis is disposed within the outer sheath during delivery and the distal tip is distal to a distal end of the outer sheath during delivery; and deploying the self-expanding prosthesis at the target location via relative axial movement of the outer sheath and an assembly of the inner shaft, the self-expanding prosthesis, the distal tip and the pusher shaft such that the self-expanding prosthesis is disposed outside of the outer sheath after deployment, wherein the self-expanding prosthesis foreshortens during deployment and wherein the outer sheath is proximally retracted and the assembly of the inner shaft, the self-expanding prosthesis, the distal tip and the pusher shaft is simultaneously distally advanced as the self-expanding prosthesis is deployed in order to compensate for the foreshortening of the self-expanding prosthesis. ### Claim 13 (depends on 12) The method of claim 12, wherein the distal advancement movement of the assembly of the inner shaft, the self-expanding prosthesis, the distal tip and the pusher shaft during the step of deploying the self-expanding prosthesis ensures that the proximal end of the self-expanding prosthesis remains positioned at the target location during deployment. ### Claim 14 (depends on 12) The method of claim 12, wherein the self-expanding prosthesis is configured to foreshorten a first distance during deployment thereof and the assembly of the inner shaft, the self-expanding prosthesis, the distal tip and the pusher shaft is configured to distally advance the self-expanding prosthesis the first distance during deployment. ### Claim 15 (depends on 12) The method of claim 12, wherein the outer sheath is proximally retracted and the assembly of the inner shaft, the self-expanding prosthesis, the distal tip and the pusher shaft is simultaneously distally advanced at different rates, the pusher shaft being distally advanced at a rate profile that corresponds with a rate of foreshortening of the self-expanding prosthesis. ### Claim 16 (depends on 15) The method of claim 15, wherein the outer sheath moves at least 50% faster than the pusher shaft. ### Claim 17 (depends on 12) The method of claim 12, wherein the distal tip engages the distal end of the outer sheath during the step of delivering the delivery device to the treatment site and wherein the distal tip is distally spaced away from the distal end of the outer sheath after the step of deploying the self-expanding prosthesis. ### Claim 18 (depends on 12) The method of claim 12, wherein the self-expanding prosthesis is a heart valve prosthesis.