Methods and devices for delivery of a prosthetic valve
Inventors
Zhang, Ji • Walsh, Brandon G. • Yang, Cheng Yong
Assignees
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Publication Number
US-11331184-B2
Publication Date
2022-05-17
Expiration Date
Abstract
Methods of assembling and delivering a valve prosthesis and delivery system are disclosed herein. A method can include housing a valve prosthesis in a compacted state within a sheath of a delivery system. The valve prosthesis can include a valve anchor and a support frame coupled to the valve anchor, and the valve anchor can include a plurality of anchoring legs having a plurality of connection apertures. The method can further include slidably coupling a pin assembly around a core member so that the pin assembly is slidable longitudinally along the core member, and inserting a plurality of pins of the pin assembly through the plurality of connection apertures of the valve anchor and a plurality of lock apertures of the delivery system to engage the plurality of anchoring legs of the valve anchor.
Core Innovation
The invention relates to a delivery system in which a sheath houses a valve prosthesis in a compacted state, where the valve prosthesis includes a valve anchor and a support frame movably coupled to the valve anchor. The valve anchor comprises rounded base portions and anchoring legs interconnected with and alternatingly interposed between the rounded base portions, and each anchoring leg has a connection aperture. The delivery system further includes a core member extending longitudinally and a lock component comprising lock apertures.
A pin assembly positioned distal to the support frame is slidably coupled to the core member, and includes pins that extend proximally through the connection apertures and through the lock apertures to engage the anchoring legs. The pin assembly coacts with an annular component disposed within a cavity, where the annular component is reciprocal between an engaged configuration at a proximal position within the cavity and a disengaged configuration at a distal position within the cavity, and the pins extend proximally from a proximal face of the annular component. A pusher component is slidable along the core member relative to the lock component.
During delivery, the sheath is retracted proximally to expand and position the valve anchor while the pins remain engaged for controlled maneuvering, and then distal advancement of a pusher moves the pin assembly to disengage the pins from the lock apertures and the valve prosthesis. This releases the valve anchor so that the support frame can expand. The system includes a nose cone and cavity that receive and permit movement of the pin assembly.
The document describes use in transcatheter access using a guidewire and positioning of the anchor in aortic sinuses, with optional rotation or repositioning, followed by release of the support frame. The engagement and disengagement of the pin assembly with the anchoring legs are coordinated with relative movement of the pusher component and the sheath, using an engaged configuration and a disengaged configuration.
Claims Coverage
The provided excerpt includes three independent claims covering a compacted sheath-based delivery system with a longitudinal core, a lock component with lock apertures, and a pin assembly whose pins engage and disengage anchoring legs of a valve anchor. Across the independent claims, at least three main inventive structures are emphasized: the specific valve anchor geometry with apertured anchoring legs, the lock/pin mechanism including an engaged/disengaged configuration, and a longitudinal pusher that actuates pin exit from lock apertures, including embodiments with a tubular component for defined face contact.
Compacted sheath-based delivery system with valve anchor and support frame
A sheath having a valve prosthesis housed therein in a compacted state, wherein the valve prosthesis comprises a valve anchor and a support frame movably coupled to the valve anchor; wherein the valve anchor comprises a plurality of rounded base portions and a plurality of anchoring legs interconnected with and alternatingly interposed between the plurality of rounded base portions, wherein each of the anchoring legs has a proximal end joined to one of the plurality of rounded base portions and a distal end having a connection aperture.
Longitudinal core, lock component, and proximal pin engagement through connection apertures and lock apertures
A core member extending longitudinally; a lock component comprising a plurality of lock apertures; a pin assembly positioned distal to the support frame and slidably coupled to the core member, wherein the pin assembly comprises a plurality of pins extending proximally through the plurality of connection apertures and through the plurality of lock apertures to engage the plurality of anchoring legs of the valve anchor.
Reciprocating annular component defining engaged and disengaged configuration with proximal pin extension
An annular component reciprocably disposed within a cavity, wherein the annular component is reciprocal between an engaged configuration at a proximal position within the cavity and a disengaged configuration at a distal position within the cavity, wherein the plurality of pins extend proximally from a proximal face of the annular component.
Pusher component slidable along core relative to lock component to actuate disengagement
A pusher component slidable along the core member and relative to the lock component.
Nose cone fixedly coupled to core with cavity containing movable pin assembly
The lock component is coupled to a nose cone that is fixedly coupled to the core member and the nose cone comprises a cavity and pin assembly is disposed and movable within the cavity.
Pusher contact causing pins to exit lock apertures to disengage from valve prosthesis
A pusher component slidably relative to the core member and the lock component to contact a pin assembly; wherein the pin assembly positioned distal to the pusher component and slidably coupled to the core member, wherein the pin assembly comprises a plurality of pins extending proximally through the plurality of lock apertures for engaging the valve prosthesis therewith, the pin assembly being moveable along the core member in response to contact from the pusher component for causing the plurality of pins to exit the lock apertures and disengage with the valve prosthesis.
Pusher with distal tubular component contacting proximal face of pin assembly
The pusher component comprises a tubular component extending distally along the core member towards the pin assembly, wherein an end of the tubular component is configured to contact a proximal face of the pin assembly.
Across the independent claims, the core coverage is a compacted sheath delivery system using a longitudinal core and a pin-and-lock mechanism to engage anchoring legs via pins extending through connection apertures and lock apertures, with a nose cone cavity that receives and permits pin assembly movement and a pusher component that causes pin exit from the lock apertures to disengage the valve prosthesis, including an embodiment where a distal tubular component of the pusher contacts the proximal face of the pin assembly.
Stated Advantages
Provides controlled maneuvering while pins remain engaged during retraction/positioning of the valve anchor.
Enables release of the valve anchor to allow expansion of the support frame after pin disengagement.
Documented Applications
Transcatheter delivery/access using a guidewire with positioning of the anchor in aortic sinuses, including optional rotation or repositioning, followed by release of the support frame.
Prosthetic heart valve delivery via a radially compact, sheath-based system for venous and other transcatheter access.
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