Epicardial anchor devices and methods
Inventors
Vidlund, Robert M. • Christianson, Mark • Ekvall, Craig
Assignees
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Publication Number
US-12274615-B2
Publication Date
2025-04-15
Expiration Date
Abstract
Apparatus and methods are described herein for anchoring a prosthetic heart valve. In some embodiments, an apparatus includes a tether attachment member that includes a base member that defines at least a portion of a tether passageway through which a portion of a tether extending from a prosthetic heart valve can be received therethrough. The base member defines a locking pin channel that intersects the tether passageway. A locking pin is disposable within the locking pin channel and movable between a first position in which the locking pin is at a spaced distance from the tether passageway, and a second position in which the locking pin intersects the tether passageway and can engage the portion of a tether disposed therein to secure the tether to the tether attachment member.
Core Innovation
The disclosed invention relates to an epicardial anchor device for securing a tether of a prosthetic heart valve at a ventricular end and for sealing a ventricular wall puncture site. The system includes a tether attachment member or base member defining a tether passageway sized and shaped to receive the tether therethrough, and the base member defines a locking pin channel that intersects the tether passageway so that a locking pin can engage the tether when actuated.
The anchor device includes a hub and a base member with the hub received within a retaining channel so that the hub rotates relative to the base member. Hub rotation moves a locking pin assembly between an unpinned condition and a pinned condition, and in the unpinned condition the piercing portion of the locking pin assembly is disposed outside of the tether passageway such that no portion extends through the tether passageway, while in the pinned condition the piercing portion extends through the tether passageway to pierce the tether.
The hub includes a driver portion received within a curved cam channel to drive the locking pin through the tether passageway, including a lever arm with open and closed states and a rotatable hub with an asymmetrical or spiral curved cam channel. The description further includes optional epicardial pad(s) and/or a sleeve gasket for sealing, and additional features for tether threading and tensioning and for coupling to a delivery device via structural cutouts, side openings, and coupling pins.
Claims Coverage
The provided independent claims are 3 in total (clm-00001, clm-00014, clm-00017). Across these independent claims, the coverage centers on an epicardial anchor device with a rotating hub that drives a locking pin to pierce a tether only in a pinned condition, together with a curved cam channel, a tube member portion of the tether passageway, and an optional ventricular wall contact pad assembly.
Hub-driven locking pin via curved cam channel
A prosthetic heart valve system including an anchor device having a base member and a hub, with the hub rotatable between an unpinned condition and a pinned condition so that a piercing portion of a locking pin assembly is disposed outside the tether passageway in the unpinned condition and extends through the tether passageway to pierce the tether in the pinned condition, wherein rotating the hub drives the locking pin through the tether passageway and the locking pin assembly includes a driver portion received within a curved cam channel of the hub.
Hub-driven locking pin with tube member portion of tether passageway
A prosthetic heart valve system including an anchor device having a base member and a hub defining a tether passageway and a locking pin channel intersecting the tether passageway, with hub rotation between an unpinned condition and a pinned condition such that the piercing portion of the locking pin assembly is outside the tether passageway in the unpinned condition and extends through the tether passageway to pierce the tether in the pinned condition, wherein the anchor device includes a tube member coupled to the base member and the tube member defines a portion of the tether passageway.
Ventricular wall contact pad in pinned tether condition
A prosthetic heart valve system including an anchor device with a base member and a hub defining a tether passageway and a locking pin channel intersecting the tether passageway, with hub rotation between an unpinned condition and a pinned condition so that the piercing portion of the locking pin assembly is outside the tether passageway in the unpinned condition and extends through the tether passageway to pierce the tether in the pinned condition, wherein the anchor device includes a pad assembly configured to contact a ventricular wall of a heart when the prosthetic heart valve is implanted, the tether is received within the tether passageway, and the hub is in the pinned condition.
All independent claims share a tether passageway intersected by a locking pin channel, where hub rotation transitions the locking pin assembly between an unpinned condition and a pinned condition. The differentiation in the independent claims is tied to a driver portion received in a curved cam channel, a tube member that forms part of the tether passageway, and an anchor device pad assembly configured to contact the ventricular wall when implanted.
Stated Advantages
Reduction of hemodynamic leakage at a ventricular puncture site via sealing by the disclosed anchor-device configuration and optional pads or sleeve gasket.
Documented Applications
Transcatheter/epicardial deployment scenarios for implanting a prosthetic heart valve with an anchored tether and an epicardial anchor device for puncture closure and leakage reduction.
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