# US 11,026,823 B2 · Method and apparatus for controlling the deployment of a stent > Agents: this data is available as JSON from the patentgrep API and MCP server — see https://patentgrep.com/llms.txt - Number: US 11,026,823 B2 - Document ID: US11026823B2 - Status: Granted - Kind: B2 - Application number: 16/180,804 - Filed: 2018-11-05 - Published: 2019-03-07 - Granted: 2021-06-08 - Earliest claimed: 2011-06-03 - Assignees: Vascutek Limited - Applicants: Vascutek Limited - Inventors: Gary Peter McDonald; David Granville Stevenson - Web page: https://patentgrep.com/patent/US11026823B2 ## CPC - A61F 2/966: with relative longitudinal movement between outer sleeve and prosthesis, e.g. using a push rod - A61F 2/07: Stent-grafts - A61F 2/9517: {handle assemblies therefor} - A61F 2002/9511: {the retaining means being filaments or wires} - A61F 2002/9665: {with additional retaining means} - 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 control system for deploying a stent graft including a resilient ring stent at one end, provides a delivery shaft carrying the stent graft with the ring stent adjacent a proximal end of the shaft for insertion into a lumen; a retractable sleeve for containing the stent graft on the delivery shaft; a control handle adjacent the distal end, of the delivery shaft; and stent peak and valley control wires extending from the proximal end of the delivery shaft to peak and valley controllers at the control handle. Use of the control wires effects movement and/or rotation of the graft allowing fine control of deployment in the lumen. ## Claims ### Claim 1 A delivery apparatus, the apparatus comprising: a delivery shaft with a tubular prosthesis mounted on a proximal end thereof for insertion into a lumen and a distal end remote from the proximal end, the tubular prosthesis comprising a sleeve and at least one discrete axially-extending ring stent that includes a plurality of peaks defining a first axial end thereof and a plurality of valleys defining a second axial end thereof opposite the first axial end, the plurality of peaks and the plurality of valleys being alternatingly arranged and comprising portions thereof that change axial directions, wherein the at least one discrete axially-extending ring stent is attached to the sleeve and configured to maintain patency of the sleeve after deployment of the tubular prosthesis; a retractable sleeve adapted to contain the tubular prosthesis mounted on the delivery shaft; a control handle proximate to the distal end of the delivery shaft; at least one stent peak control wire extending from the control handle and physically coupled to at least one peak of the plurality of peaks at an at least one peak connection point located directly at the at least one peak; at least one peak controller at the control handle adapted to control the position of the at least one stent peak control wire to selectively open the at least one peak from a collapsed state and collapse the at least one peak from an open state; at least one stent valley control wire extending from the control handle and physically coupled to at least one valley of the plurality of valleys at an at least one valley connection point located directly at the at least one valley; and at least one valley controller at the control handle adapted to control the position of the at least one stent valley control wire to selectively open the at least one valley from a collapsed state and collapse the at least one valley from an open state. ### Claim 2 (depends on 1) The apparatus of claim 1, wherein the at least one discrete axially-extending ring stent comprises a plurality of discrete axially-extending ring stents attached to the sleeve at spaced intervals. ### Claim 3 (depends on 2) The apparatus of claim 2, wherein the sleeve is a flexible tubular conduit. ### Claim 4 (depends on 1) The apparatus of claim 1, wherein the selectively opening and collapsing the at least one peak comprises selectively opening and collapsing at least a first portion of the at least one discrete axially-extending ring stent, and the selectively opening and collapsing the at least one valley comprises selectively opening and collapsing at least a second portion of the at least one discrete axially-extending ring stent. ### Claim 5 (depends on 1) The apparatus of claim 1, wherein the at least one discrete axially-extending ring stent of the tubular prosthesis is mounted on the delivery shaft in a collapsed configuration and is naturally biased into an open configuration from the collapsed configuration. ### Claim 6 (depends on 1) The apparatus of claim 1, wherein the at least one stent peak control wire is directly physically coupled to the at least one peak at the at least one peak connection point. ### Claim 7 (depends on 1) The apparatus of claim 1, wherein the at least one stent valley control wire is directly physically coupled to the at least one valley at the at least one valley connection point. ### Claim 8 (depends on 1) The apparatus of claim 1, wherein the at least one peak connection point comprises a respective peak connection loop. ### Claim 9 (depends on 1) The apparatus of claim 1, wherein the at least one valley connection point comprises a respective valley connection loop. ### Claim 10 (depends on 1) The apparatus of claim 1, wherein the at least one peak connection point comprises at least one peak eyelet, and the at least one stent peak control wire is threaded through the at least one peak eyelet. ### Claim 11 (depends on 10) The apparatus of claim 10, wherein the at least one stent peak control wire comprises at least one looped wire which extends from the control handle, to the at least one peak connection point, and back to the control handle. ### Claim 12 (depends on 11) The apparatus of claim 11, further comprising at least one release wire extending from the control handle and to the at least one peak connection point, and wherein release of the at least one release wire releases the at least one peak connection point such that the at least one stent peak control wire is physically decoupled from the at least one peak. ### Claim 13 (depends on 1) The apparatus of claim 1, wherein the at least one release wire is releasably coupled to the control handle. ### Claim 14 (depends on 1) The apparatus of claim 1, wherein the at least one valley connection point comprises at least one valley eyelet, and the at least one stent valley control wire is threaded through the at least one valley eyelet. ### Claim 15 (depends on 14) The apparatus of claim 14, wherein the at least one stent valley control wire comprises at least one looped wire which extends from the control handle, to the at least one valley connection point, and back to the control handle. ### Claim 16 (depends on 15) The apparatus of claim 15, further comprising at least one release wire extending from the control handle and to the at least one valley connection point, and wherein release of the at least one release wire releases the at least one valley connection point such that the at least one stent valley control wire is physically decoupled from the at least one valley. ### Claim 17 (depends on 16) The apparatus of claim 16, wherein the at least one release wire is releasably coupled to the control handle. ### Claim 18 (depends on 1) The apparatus of claim 1, wherein at least one of: the at least one peak connection point comprises at least one point on the at least one peak of the at least one discrete axially-extending ring stent; and the at least one valley connection point comprises at least one point on the at least one valley of the at least one discrete axially-extending ring stent. ### Claim 19 (depends on 1) The apparatus of claim 1, wherein the at least one discrete axially-extending ring stent comprises at least one discrete saddle-shaped ring stent, wherein the plurality of peaks are only a pair of peaks and the plurality of valleys are only a pair of valleys. ### Claim 20 (depends on 19) The apparatus of claim 19, wherein the pair of peaks are diametrically opposed to each other, and the pair of valleys are diametrically opposed to each other. ### Claim 21 (depends on 1) The apparatus of claim 1, wherein the at least one discrete axially-extending ring stent is formed of a resilient alloy material. ### Claim 22 (depends on 1) The apparatus of claim 1, wherein the at least one stent peak control wire comprises at least two stent peak control wires extending from the control handle, and wherein the at least one peak controller is adapted to control the position of the at least two stent peak control wires. ### Claim 23 (depends on 1) The apparatus of claim 1, wherein the at least one stent valley control wire comprises at least two stent valley control wires extending from the control handle, and wherein the at least one valley controller is adapted to control the position of the at least two stent valley control wires. ### Claim 24 (depends on 1) The apparatus of claim 1, wherein the delivery shaft includes a plurality of longitudinal passages, each stent peak control wire and stent valley control wire extending through a respective longitudinal passage. ### Claim 25 (depends on 1) The apparatus of claim 1, comprising one or more tow wires extending from the proximal end of the delivery shaft to a proximal end of the tubular prosthesis mounted on the delivery shaft. ### Claim 26 (depends on 1) The apparatus of claim 1, comprising one or more back tether wires extending from the proximal end of the delivery shaft to a distal end of the tubular prosthesis mounted on the delivery shaft. ### Claim 27 (depends on 1) The apparatus of claim 1, wherein the control handle includes a manifold having a plurality of apertures, each stent peak control wire and stent valley control wire extending through a respective aperture. ### Claim 28 (depends on 27) The apparatus of claim 27, wherein the manifold includes a plurality of haemostasis valves switchable between open and closed positions. ### Claim 29 (depends on 1) The apparatus of claim 1, wherein the at least one peak controller comprises a rotatable collar that is rotatable about a longitudinal axis of the control handle. ### Claim 30 (depends on 29) The apparatus of claim 29, wherein rotation of the rotatable collar about the longitudinal axis of the control handle selectively opens or closes at least a portion of the at least one discrete axially-extending ring stent. ### Claim 31 (depends on 1) The apparatus of claim 1, wherein the at least one valley controller comprises at least one slider. ### Claim 32 (depends on 31) The apparatus of claim 31, wherein the at least one valley controller includes at least one actuating surface and at least one ratchet adapted to allow the at least one slider to move when the at least one actuating surface is depressed and to hold the at least one slider in an engaged position when the at least one actuating surface is released. ### Claim 33 (depends on 31) The apparatus of claim 31, wherein the at least one slider is mounted for longitudinal sliding movement. ### Claim 34 (depends on 31) The apparatus of claim 31, wherein the at least one slider includes a wire connector to which is connected the at least one stent valley control wire. ### Claim 35 (depends on 31) The apparatus of claim 31, wherein sliding movement of the at least one slider in a first direction opens at least a portion of the at least one discrete axially-extending ring stent, and sliding movement of the at least one slider in a second direction collapses at least a portion of the at least one discrete axially-extending ring stent. ### Claim 36 (depends on 1) The apparatus of claim 1, wherein the at least one peak controller is positioned proximally relative to the at least one valley controller at the control handle. ### Claim 37 (depends on 1) The apparatus of claim 1, wherein the at least one peak controller and the at least one valley controller are separately controllable with respect to each other. ### Claim 38 (depends on 1) The apparatus of claim 1, wherein the at least one stent peak control wire comprises a first stent peak control wire and a second stent peak control wire, and the at least one stent valley control wire comprises a first stent valley control wire and a second stent valley control wire, wherein the at least one peak connection point comprises a first peak connection point and a second peak connection point, and the at least one valley connection point comprises a first valley connection point and a second valley connection point, wherein the plurality of peaks comprise a first peak and a second peak, and the plurality of valleys comprise a first valley and a second valley, wherein the first stent peak control wire is physically coupled to the first peak at the first peak connection point, and the second stent peak control wire is physically coupled to the second peak at the second peak connection point, and wherein the first stent valley control wire is physically coupled to the first valley at the first valley connection point, and the second stent valley control wire is physically coupled to the second valley at the second valley connection point. ### Claim 39 (depends on 38) The apparatus of claim 38, wherein the at least one valley controller comprises a first valley controller and a second valley controller, and wherein the first valley controller is adapted to control the position of at least the first stent valley control wire to selectively open at least the first valley from the collapsed state and collapse at least the first valley from the open state, and the second valley controller is adapted to control the position of at least the second stent valley control wire to selectively open at least the second valley from a collapsed state and collapse at least the second valley from an open state. ### Claim 40 (depends on 1) A method, comprising: providing the delivery apparatus of claim 1; holding the at least one stent peak control wire under tension such that the at least one peak connection point is held by the at least one stent peak control wire and the at least one peak is held in a collapsed arrangement positioned proximate to the delivery shaft; holding the at least one stent valley control wire under tension such that the at least one valley connection point is held by the at least one stent valley control wire and the at least one valley is held in a collapsed arrangement positioned proximate to the delivery shaft; operating the at least one peak controller and the at least one valley controller to permit movement of the at least one stent peak control wire and the at least one stent valley control wire along the delivery shaft such that the at least one peak and the at least one valley are urged by resilience of the at least one discrete axially-extending ring stent to adopt at least partially deployed positions positioned distal to the delivery shaft as compared to the collapsed arrangement. ### Claim 41 (depends on 40) The method of claim 40, further comprising further operating the at least one peak controller and the at least one valley controller to effectuate movement of the at least one stent peak control wire and the at least one stent valley control wire along the delivery shaft such that the at least one peak and the at least one valley are forced toward the delivery shaft to at least partially collapsed arrangements. ### Claim 42 (depends on 40) The method of claim 40, wherein operating the at least one peak controller and the at least one valley controller comprises separately operating the at least one peak controller and the at least one valley controller with respect to each other. ### Claim 43 (depends on 40) The method of claim 40, wherein the at least one peak controller is positioned proximally relative to the at least one valley controller at the control handle. ### Claim 44 (depends on 40) The method of claim 40, wherein operating the at least one peak controller and the at least one valley controller comprises rotating and axially sliding the at least one peak controller and the at least one valley controller, respectively. ### Claim 45 (depends on 40) The method of claim 40, wherein at least one of: the at least one stent peak control wire is directly physically coupled to the at least one peak at the at least one peak connection point; and the at least one stent valley control wire is directly physically coupled to the at least one valley at the at least one valley connection point. ### Claim 46 (depends on 40) The method of claim 40, wherein the at least one peak connection point comprises at least one peak eyelet, and the at least one stent peak control wire is threaded through the at least one peak eyelet, and wherein the at least one stent peak control wire comprises at least one looped wire. ### Claim 47 (depends on 46) The method of claim 46, wherein the delivery apparatus further comprises at least one release wire extending from the control handle and to the at least one peak connection point, and wherein the method further comprises releasing the at least one release wire to release the at least one peak connection point to physically decouple the at least one stent peak control wire from the at least one peak. ### Claim 48 (depends on 40) The method of claim 40, wherein the at least one valley connection point comprises at least one valley eyelet, and the at least one stent valley control wire is threaded through the at least one valley eyelet, and wherein the at least one stent valley control wire comprises at least one looped wire. ### Claim 49 (depends on 48) The method of claim 48, wherein the delivery apparatus further comprises at least one release wire extending from the control handle and to the at least one valley connection point, and wherein the method further comprises releasing the at least one release wire to release the at least one valley connection point to physically decouple the at least one stent valley control wire from the at least one valley.