Heart valve prosthesis delivery system
Inventors
Zhang, Ji • Walsh, Brandon G. • Yang, Cheng Yong • Zhu, Jinhua
Assignees
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Abstract
A heart valve prosthesis delivery device can be modified in situ to facilitate retrieval of the device from a patient after delivery of a heart valve prosthesis. The device can include a nose cone that permits enclosures of the device to be drawn together in an aligned configuration, reducing the likelihood that the device will get caught on the prosthesis or vasculature as the device is retrieved from the patient.
Core Innovation
The invention relates to a valve prosthesis delivery device for delivering a valve prosthesis, including an elongate core member extending along a longitudinal axis. A distal carrier assembly includes a distal enclosure and a proximal enclosure, where the proximal enclosure is separable relative to the distal enclosure and receives at least a portion of the valve prosthesis. A nose cone is disposed within the distal enclosure.
The nose cone is biased toward a proximal position such that a ramped surface extends from the distal enclosure and contacts to facilitate axial alignment of the proximal enclosure with the distal enclosure upon movement of the proximal enclosure toward a collapsed configuration. Upon release of the valve prosthesis, the nose cone is movable to an extended position, and the separable enclosure arrangement is configured to move to a collapsed or retrieval configuration with abutting and axial alignment between the enclosures and the nose cone.
The nose cone includes features that promote self-alignment into an abutting or nested retrieval configuration, including a ramped surface and, in refinements, a plunger head with deflectable petals and biasing means. In refinements, an engagement surface on the petal abuts a proximal end of a corresponding enclosure in a proximal position, and the petal can be biased to a radially extended position. The delivery device further includes arrangements intended to reduce catching during withdrawal, including smooth exterior realignment using conical or tapered ramp geometry and an alignment hub for grasper engagement alignment under vessel tortuosity.
Claims Coverage
The provided claim set includes two independent claims, each directed to a valve prosthesis delivery device that uses a separable or relative-position enclosure arrangement and a nose cone configured to produce axial alignment in a retrieval configuration. Across the two independent claims, the inventive features consistently center on (i) an elongate core member, (ii) enclosures that move relative to one another into an abutting/axially aligned retrieval configuration, and (iii) a biased or movable nose cone with a ramped surface that facilitates axial alignment.
Elongate core member with distal carrier enclosure assembly
A valve prosthesis delivery device comprising an elongate core member extending along a longitudinal axis of the device and a distal carrier assembly comprising a distal enclosure and a proximal enclosure, the distal enclosure configured to receive a portion of the valve prosthesis and the proximal enclosure coupled to the core member proximal to the distal enclosure and configured to receive at least a portion of the valve prosthesis, wherein the proximal enclosure is separable relative to the distal enclosure.
Biased nose cone with ramped surface for axial alignment during collapse
A nose cone disposed within the distal enclosure, the nose cone biased toward a proximal position in which a ramped surface of the nose cone extends from the distal enclosure, the ramped surface contacting and facilitating axial alignment of the proximal enclosure with the distal enclosure upon movement of the proximal enclosure toward the distal enclosure to a collapsed configuration.
First and second enclosures move to an abutting, axially aligned retrieval configuration with a movable nose cone
A valve prosthesis delivery device comprising an elongate core member, a first enclosure coupled to the core member and configured to receive at least a portion of the valve prosthesis, a nose cone disposed within the first enclosure and movable to an extended position in which the nose cone extends from the first enclosure upon release of the valve prosthesis therefrom, and a second enclosure coupled to the core member and moveable relative to the first enclosure, the second enclosure moveable toward the first enclosure and the nose cone to an abutting position in which the second enclosure is abutting the nose cone and axially aligned with the first enclosure in a retrieval configuration.
The claim coverage emphasizes a delivery device architecture that achieves axial alignment in a collapsed or retrieval configuration by combining separable/relative enclosures with a nose cone having a ramped surface and/or an extended abutting interface. Dependent refinements described in the claim set further specify biasing, plunger head with deflectable petals and engagement abutting features, and ramp geometry constraints such as conical tapering.
Stated Advantages
Reduced catching on prosthesis/vasculature during retrograde transfemoral delivery.
Smoother retrieval profile.
Improved maneuverability/control.
Reduced trauma during retrograde transfemoral delivery.
Documented Applications
Transcatheter aortic valve implantation (TAVI) / TAVR via retrograde transfemoral delivery.
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