Methods and devices for delivery of a prosthetic valve
Inventors
Zhang, Ji • Walsh, Brandon G. • Yang, Cheng Yong
Assignees
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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 assembly and transcatheter delivery of a prosthetic heart valve to a target location in a vessel of a subject. A valve anchor is positioned using a delivery system that includes a nose cone, and a sheath is proximally retracted to permit anchoring members of the valve anchor to expand for anchoring at the target location. During this sheath retraction, engagement between an anchoring leg of the valve anchor and an engagement mechanism of the delivery system is maintained.
The engagement mechanism includes a pusher component, a pin assembly, and a lock component. After the valve anchor is expanded, the pusher component is distally advanced relative to a core member to contact and distally advance the pin assembly relative to the lock component and the sheath, moving the pin assembly toward the nose cone. This action disengages the pin assembly from the lock component, thereby permitting release of the anchoring leg of the valve anchor from the delivery system.
The described configuration further includes structural and positional relationships of components within the sheath, including serial positioning of the anchor and a support frame within the sheath. After release of the anchoring legs, the support frame is described as expanding within a lumen of the valve anchor, and the disclosure also references optional sutures that allow independent or controlled expansion and rotational restriction. Additional geometry features are described as preserving access to coronary ostia.
Claims Coverage
The provided independent claims cover a valve-prosthesis delivery sequence with three recurring inventive features: maintaining engagement during sheath retraction, driving a pin assembly toward a nose cone to disengage a lock component, and using lock-aperture or cavity-based engagement and release structures. Dependent claim content also reflects post-release expansion of a support frame within a lumen of the valve anchor.
Sheath retraction while maintaining engaged delivery-system engagement during anchor expansion
Proximally retracting a sheath of the delivery system to permit anchoring members of the valve anchor to expand for anchoring the valve anchor at the target location while maintaining engagement between an anchoring leg of the valve anchor and an engagement mechanism of the delivery system.
Pusher-driven pin assembly disengagement from a lock component to release the anchoring leg
Distally advancing the pusher component relative to a core member of the delivery system to contact and distally advance the pin assembly relative to the lock component and the sheath and towards the nose cone to disengage the pin assembly from the lock component, thereby permitting release of the anchoring leg of the valve anchor from the delivery system.
Pin assembly engagement and disengagement using lock apertures
Maintaining the engagement mechanism in the engaged configuration comprises extending one or more pins through one or more corresponding lock apertures; shifting the engagement mechanism into the released configuration comprises sliding one or more pins out of one or more corresponding lock apertures.
Piston-in-cavity lock component driven by pusher advancement
The engagement mechanism comprises a pusher component, a pin assembly with a piston member, and a lock component having a cavity; distally advancing the pusher component relative to a core member moves the piston member distally within the cavity and disengages the pin assembly from the lock component.
Across the independent claims, the key claim coverage is directed to maintaining engagement during proximally retracting a sheath to allow valve-anchor expansion, and then distally advancing a pusher to drive a pin assembly relative to a lock component to disengage the pin assembly and release anchoring members. The coverage includes lock-aperture-based pin engagement/disengagement and a piston member moving distally within a lock cavity as part of the disengagement mechanism.
Stated Advantages
Not explicitly described in patent.
Documented Applications
Not explicitly described in patent.
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