Stent-valve delivery system
A delivery system for delivering a stent-valve may include an inner shaft including a distal tip, a stent-valve crimped onto the inner shaft, a distal sheath disposed over at least a lower portion of the stent-valve, and a proximal sheath disposed over at least an upper portion of the stent-valve. The distal sheath has a proximal free end with an angled proximal edge defining a short side and a long side of the distal sheath. The proximal sheath is actuatable independently from the distal sheath, and moveable proximally to release the upper portion of the stent-valve. The distal sheath is moveable distally to release the lower portion of the stent-valve. The angled proximal edge releases a first side of the lower portion of the stent-valve before an opposite second side.
1 . A delivery system configured to deliver a stent-valve, the delivery system comprising:
an inner shaft including a distal tip;
a stent-valve crimped onto the inner shaft, the stent-valve including an upper portion, a lower portion, and a valve;
a distal sheath disposed over at least the lower portion of the stent-valve, the distal sheath having a distal end coupled to the distal tip and a proximal free end having an angled proximal edge defining a short side and a long side of the distal sheath; and
a proximal sheath disposed over at least the upper portion of the stent-valve;
wherein the proximal sheath is actuatable independently from the distal sheath, and moveable proximally to release the upper portion of the stent-valve;
wherein the distal sheath is moveable distally to release the lower portion of the stent-valve, wherein the angled proximal edge releases a first side of the lower portion of the stent-valve before an opposite second side.
2 . The delivery system of claim 1 , wherein the angled proximal edge on the distal sheath is angled 10 degrees to 70 degrees relative to a transverse axis of the distal sheath.
3 . The delivery system of claim 2 , wherein the angled proximal edge has a 10-degree to 20-degree angle.
4 . The delivery system of claim 1 , further comprising a marker indicating a position of the long side of the distal sheath.
5 . The delivery system of claim 4 , wherein the marker is a radiopaque marker on the distal sheath along the long side.
6 . The delivery system of claim 4 , wherein the marker is a radiopaque marker on the lower portion of the stent-valve.
7 . The delivery system of claim 1 , wherein the lower portion of the stent-valve includes a plurality of lower crowns, wherein the long side includes a proximal extension configured to cover 1-5 of the lower crowns while the remaining lower crowns are released.
8 . The delivery system of claim 1 , wherein the proximal sheath has a distal free end with an angled distal edge, wherein when the proximal sheath is moved proximally, the angled distal edge releases a first side of the upper portion of the stent-valve before an opposite second side.
9 . The delivery system of claim 1 , wherein the upper portion of the stent-valve includes a plurality of arches and a plurality of upper crowns, wherein a distal end of the proximal sheath extends over the plurality of arches and the plurality of upper crowns.
10 . The delivery system of claim 1 , wherein the distal sheath includes a polymer sheath and a reinforcement coil, wherein the reinforcement coil extends from the distal end of the distal sheath to a position adjacent the angled proximal edge.
11 . The delivery system of claim 10 , wherein the distal sheath includes a braid disposed proximal of the reinforcement coil.
12 . A delivery system configured to deliver a stent-valve, the delivery system comprising:
an inner shaft including a distal tip;
a stent-valve crimped onto the inner shaft, the stent-valve including a plurality of upper crowns, a plurality of lower crowns, and a valve;
a distal sheath disposed over and constraining the lower crowns, the distal sheath having a distal end coupled to the distal tip and a proximal free end having an angled proximal edge angled 5 degrees to 70 degrees relative to a transverse axis of the distal sheath; and
a proximal sheath disposed over the upper crowns of the stent-valve;
wherein the proximal sheath is actuatable independently from the distal sheath, and moveable proximally to release the upper crowns of the stent-valve;
wherein the distal sheath is moveable distally to release the lower crowns of the stent-valve, wherein the angled proximal edge releases the lower crowns incrementally from a first side to a second side of the stent-valve.
13 . The delivery system of claim 12 , wherein the angled proximal edge has a 10-degree to 20-degree angle.
14 . The delivery system of claim 12 , wherein the angled proximal edge of the distal sheath defines a long side and an opposing short side of the distal sheath, the delivery system further comprising a marker indicating a position of the long side of the distal sheath.
15 . The delivery system of claim 14 , wherein the marker is a radiopaque marker on the distal sheath along the long side.
16 . The delivery system of claim 14 , wherein the marker is a radiopaque marker on one of the lower crowns positioned under the long side of the distal sheath.
17 . The delivery system of claim 14 , wherein the long side includes a proximal extension configured to cover 1-5 of the lower crowns while the remaining lower crowns are released.
18 . A method of delivering a stent-valve, comprising:
inserting a distal tip of a stent-valve delivery system through a patient's aorta and aortic valve, the delivery system including:
an inner shaft including the distal tip;
a stent-valve crimped onto the inner shaft, the stent-valve including an upper portion, a lower portion, and a valve;
a distal sheath disposed over at least the lower portion of the stent-valve, the distal sheath having a distal end coupled to the distal tip and a proximal free end having an angled proximal edge defining a short side and a long side, the distal sheath including a radiopaque marker on the long side; and
a proximal sheath disposed over at least the upper portion of the stent-valve;
aligning the radiopaque marker along an outer curve of the aorta;
moving the proximal sheath proximally to release the upper portion of the stent-valve; and
moving the distal sheath distally to release the lower portion of the stent-valve, the angled proximal edge releasing a first side of the lower portion of the stent-valve positioned on an inner curve of the aorta, before an opposite second side.
19 . The method of claim 18 , wherein moving the distal sheath includes a first stage in which the distal sheath is moved distally to a first position in which a first side of the lower portion of the stent-valve is released while a second side of the lower portion of the stent-valve remains constrained by the distal sheath, and a second stage in which the distal sheath is moved further distally until an entirety of the lower portion of the stent-valve is released from the distal sheath.
20 . The method of claim 19 , wherein after the first stage, the first side of the lower portion of the stent-valve is allowed to engage a desired portion of the patient's anatomy, and then the second stage is performed to fully release the stent-valve.