Prosthetic valve with expandable frame and associated systems and methods
Aspects of the disclosure relate to prosthetic valves having a frame, a frame cover, and a leaflet construct. Some aspects are directed to a diametric taper for the prosthetic valve for achieving enhanced performance of the prosthetic valve under operational conditions, enhanced compressibility and delivery characteristics, and other additional or alternative advantages. Other aspects are directed toward unique assembly and attachment methods for securing leaflet constructs to support structures. Other aspects are directed toward features for interacting with transcatheter delivery systems. Still other aspects are directed to such apparatuses, systems, and methods for valve replacement, such as cardiac valve replacement.
1 . A prosthetic valve comprising:
a radially compressible and expandable frame comprising a plurality of frame members and a plurality of commissure posts, the frame extending from an inflow end to an outflow end, the plurality of frame members arranged in a plurality of rows of frame members, wherein the rows of frame members are arranged to form a plurality of cells, wherein the plurality of cells form a plurality of rows of cells including an inflow row of cells and an outflow row of cells, wherein the rows of cells define a central lumen of the frame extending from the inflow row of cells to the outflow row of cells; and
a leaflet construct including a plurality of leaflets, wherein an outflow end portion of each leaflet of the plurality of leaflets is coupled to one or more of the plurality of commissure posts and an inflow end portion of each leaflet of the plurality of leaflets is disposed in the central lumen and coupled to at least a portion of the plurality of cells;
wherein each of the commissure posts comprises an intermediate member, a first leg member, and a second leg member, and wherein the first and second leg members are disposed on opposing sides of the intermediate member and form a first slot between the first leg member and the intermediate member and a second slot between the second leg member and the intermediate member, wherein the first slot extends from a first upper end to a first lower end, wherein the second slot extends from a second upper end to a second lower end, wherein the first leg member is connected to the intermediate member to form a closed end at the first upper end of the first slot, wherein the second leg member is connected to the intermediate member to form a closed end at the second upper end of the second slot, wherein the closed ends of the first and second slots are located in an outflow end portion of the commissure post; and
wherein the first slot comprises a first parallel portion extending from the first lower end toward the first upper end, wherein the second slot comprises a second parallel portion extending from the second lower end toward the second upper end, wherein the first parallel portion is parallel to the second parallel portion.
2 . The prosthetic valve of claim 1 , wherein the intermediate member extends from an apex of one of the cells at the outflow end of the frame.
3 . The prosthetic valve of claim 1 , wherein the first and second slots extend from an inner side to an outer side of the frame.
4 . The prosthetic valve of claim 1 , wherein the first and second slots extend in a radial direction relative to a central longitudinal axis of the frame.
5 . The prosthetic valve of claim 1 , the respective first and second lower ends of the first and second slots are oriented toward the inflow end of the frame, and the respective first and second upper ends of the first and second slots are oriented toward the outflow end of the frame.
6 . The prosthetic valve of claim 1 , wherein each commissure post further comprises a distal end portion, and wherein each of the first leg member and the second leg member extends from the distal end portion in a direction away from the outflow end of the frame.
7 . The prosthetic valve of claim 1 , wherein the first slot comprises a first diverging portion extending between the first parallel portion and the first upper end and the second slot comprises a second diverging portion extending between the second parallel portion and the second upper end, wherein each of the first and second parallel portions is parallel to a longitudinal axis of the intermediate member, and wherein the first diverging portion extends in a first direction that diverges from the longitudinal axis of the intermediate member, and wherein the second diverging portion extends in a second direction that diverges from the longitudinal axis of the intermediate member.
8 . The prosthetic valve of claim 1 , wherein the plurality of leaflets comprises a first leaflet and a second adjacent leaflet, wherein a first commissure tab of the first leaflet extends through the first slot and a second commissure tab of the second leaflet extends through the second slot.
9 . The prosthetic valve of claim 8 , further comprising first and second retaining members, wherein the first retaining member contacts the first commissure tab exterior of an outer surface of the frame, and wherein the second retaining member contacts the second commissure tab exterior of the outer surface of the frame.
10 . The prosthetic valve of claim 9 , wherein the first retaining member is configured to resist movement of the first commissure tab relative to the first slot, and wherein the second retaining member is configured to resist movement of the second commissure tab relative to the second slot.
11 . The prosthetic valve of claim 9 , wherein the first retaining member is coupled to the first commissure tab and the second retaining member is coupled to the second commissure tab.
12 . The prosthetic valve of claim 9 , wherein first and second passes of the first commissure tab extend through the first slot to form a first loop exterior of the outer surface of the frame, wherein first and second passes of the second commissure tab extend through the second slot to form a second loop exterior of the outer surface of the frame, and wherein the first retaining member extends through the first loop and the second retaining member extends through the second loop.
13 . The prosthetic valve of claim 12 , wherein a third pass of the first commissure tab is wrapped around the first leg member from an inner surface to the outer surface of the frame, and wherein a third pass of the second commissure tab is wrapped around the second leg member from the inner surface to the outer surface of the frame.
14 . The prosthetic valve of claim 13 , wherein the third passes of each of the first commissure tab and the second commissure tab are coupled to each other exterior of the outer surface of the frame via a secondary coupler.
15 . The prosthetic valve of claim 1 , wherein, in a radially expanded state of the frame, each of the first and second leg members extends in a direction that is parallel to the intermediate member.
16 . The prosthetic valve of claim 1 , wherein the first parallel portion extends from the first lower end to the first upper end and the second parallel portion extends from the second lower end to the second upper end.
17 . A prosthetic valve comprising:
a first leaflet and a second leaflet; and
a radially compressible and expandable frame extending from an inflow end to an outflow end and comprising a commissure support structure, the commissure support structure including a first slot having a first commissure tab of the first leaflet extending therethrough and a second slot having a second commissure tab of the second leaflet extending therethrough;
wherein a first retaining member is engaged with the first commissure tab on an outer side of the commissure support structure for retaining a position of the first commissure tab relative to the first slot, and a second retaining member is engaged with the second commissure tab on the outer side of the commissure support structure for retaining a position of the second commissure tab relative to the second slot; and
wherein the first commissure tab is looped around the first retaining member and the second commissure tab is looped around the second retaining member.
18 . The prosthetic valve of claim 17 , wherein the commissure support structure comprises a first leg member, a second leg member, and an intermediate member disposed between the first and second leg members, wherein the first slot extends from an inner side to an outer side of the frame between the first leg member and the intermediate member, and wherein the second slot extends from the inner side to the outer side of the frame between the second leg member and the intermediate member.
19 . The prosthetic valve of claim 17 , wherein the first commissure tab looped around the first retaining member forms a first loop and the second commissure tab looped around the second retaining member forms a second loop; and
wherein the first loop has a greater width than the first slot and the second loop has a greater width than the second slot.
20 . A prosthetic valve comprising:
a leaflet construct including a first leaflet and a second adjacent leaflet;
a radially compressible and expandable frame comprising a commissure support structure and a plurality of frame members forming a plurality of diamond-shaped cells, the frame extending from an inflow end to an outflow end; and
wherein the commissure support structure comprises an intermediate member extending from an outflow end apex of one of the diamond-shaped cells and first and second leg members on opposing sides of the intermediate member; and
wherein a first commissure tab of the first leaflet extends through a first slot between the first leg member and the intermediate member and extends around the first leg member and a second commissure tab of the second leaflet extends through a second slot between the second leg member and the intermediate member and extends around the second leg member.
21 . The prosthetic valve of claim 20 , wherein the first commissure tab is looped around a first retaining member exterior of the frame to form a first loop and the second commissure tab is looped around a second retaining member exterior of the frame to form a second loop, wherein the first loop has a greater width than the first slot and the second loop has a greater width than the second slot.
22 . A prosthetic valve comprising:
a radially compressible and expandable frame comprising a plurality of frame members and a plurality of commissure posts, the frame extending from an inflow end to an outflow end, the plurality of frame members arranged in a plurality of rows of frame members, wherein the rows of frame members are arranged to form a plurality of cells, wherein the plurality of cells form a plurality of rows of cells including an inflow row of cells and an outflow row of cells, wherein the rows of cells define a central lumen of the frame extending from the inflow row of cells to the outflow row of cells; and
a leaflet construct including a plurality of leaflets, wherein an outflow end portion of each leaflet of the plurality of leaflets is coupled to one or more of the plurality of commissure posts and an inflow end portion of each leaflet of the plurality of leaflets is disposed in the central lumen and coupled to at least a portion of the plurality of cells;
wherein each of the commissure posts comprises an intermediate member, a first leg member, and a second leg member, and wherein the first and second leg members are disposed on opposing sides of the intermediate member and form a first slot between the first leg member and the intermediate member and a second slot between the second leg member and the intermediate member, wherein the first slot extends from a first upper end to a first lower end, wherein the second slot extends from a second upper end to a second lower end;
wherein the first slot comprises a first parallel portion extending from the first lower end toward the first upper end, wherein the second slot comprises a second parallel portion extending from the second lower end toward the second upper end, wherein the first parallel portion is parallel to the second parallel portion; and
wherein the first slot comprises a first diverging portion extending between the first parallel portion and the first upper end and the second slot comprises a second diverging portion extending between the second parallel portion and the second upper end, wherein each of the first and second parallel portions is parallel to a longitudinal axis of the intermediate member, and wherein the first diverging portion extends in a first direction that diverges from the longitudinal axis of the intermediate member, and wherein the second diverging portion extends in a second direction that diverges from the longitudinal axis of the intermediate member.
23 . A prosthetic valve comprising:
a radially compressible and expandable frame comprising a plurality of frame members and a plurality of commissure posts, the frame extending from an inflow end to an outflow end, the plurality of frame members arranged in a plurality of rows of frame members, wherein the rows of frame members are arranged to form a plurality of cells, wherein the plurality of cells form a plurality of rows of cells including an inflow row of cells and an outflow row of cells, wherein the rows of cells define a central lumen of the frame extending from the inflow row of cells to the outflow row of cells, wherein each of the commissure posts comprises an intermediate member, a first leg member, and a second leg member, and wherein the first and second leg members are disposed on opposing sides of the intermediate member and form a first slot between the first leg member and the intermediate member and a second slot between the second leg member and the intermediate member, wherein the first slot extends from a first upper end to a first lower end, wherein the second slot extends from a second upper end to a second lower end;
a leaflet construct including a plurality of leaflets, wherein an outflow end portion of each leaflet of the plurality of leaflets is coupled to one or more of the plurality of commissure posts and an inflow end portion of each leaflet of the plurality of leaflets is disposed in the central lumen and coupled to at least a portion of the plurality of cells, wherein the plurality of leaflets comprises a first leaflet and a second adjacent leaflet, wherein a first commissure tab of the first leaflet extends through the first slot and a second commissure tab of the second leaflet extends through the second slot; and
first and second retaining members, wherein the first retaining member contacts the first commissure tab exterior of an outer surface of the frame, and wherein the second retaining member contacts the second commissure tab exterior of the outer surface of the frame;
wherein the first slot comprises a first parallel portion extending from the first lower end toward the first upper end, wherein the second slot comprises a second parallel portion extending from the second lower end toward the second upper end, wherein the first parallel portion is parallel to the second parallel portion.