Heart valve prosthesis delivery system
Inventors
Zhang, Ji • Walsh, Brandon G. • Yang, Cheng Yong • Zhu, Jinhua
Assignees
Interested in licensing this patent?
MTEC can help explore whether this patent might be available for licensing for your application.
Publication Number
US-11357626-B2
Publication Date
2022-06-14
Expiration Date
Abstract
The present disclosure relates to heart valve prostheses, delivery devices, actuation handles, and other improved devices and methods that facilitate delivery of a heart valve prosthesis to a defective native valve structure in a patient, such as the aortic valve.
Core Innovation
The invention relates to a valve prosthesis delivery device for delivering a valve prosthesis that comprises a valve frame and a valve anchor. The delivery device includes an elongate core member extending along a longitudinal axis, together with a proximal sheath component slidably coupled to the core member, the proximal sheath component having a proximal sheath lumen configured to receive at least a portion of the valve anchor and being proximally retractable relative to the core member to permit expansion of the valve anchor.
A distal carrier assembly includes a distal enclosure and a proximal enclosure, where the distal enclosure is coupled to the core member and includes a distal lumen configured to receive a distal portion of the valve frame in a compressed configuration. The proximal enclosure is coupled to the core member proximal to the distal enclosure and includes a proximal lumen for receiving a proximal portion of the valve frame in a compressed configuration, and the proximal enclosure is separable relative to the distal enclosure.
A plunger mechanism is disposed within the distal lumen and is moveable between a distal position and a proximal position, with biasing means biasing the plunger mechanism toward the proximal position to urge the valve frame out of the distal lumen. A plurality of grasper components is disposed within the sheath component along the elongate core member, and distal ends of the grasper components are each configured to engage the valve anchor for permitting expansion, with a separate distal hub coupled to the plurality of grasper components to align the distal ends in a common plane as the sheath component is bent.
Claims Coverage
The partial document identifies two independent claims covering 5 inventive features.
Proximally retractable proximal sheath for permitting valve anchor expansion
The device includes an elongate core member with a proximal sheath component slidably coupled to the core member, the proximal sheath component having a proximal sheath lumen configured to receive at least a portion of the valve anchor, and being proximally retractable relative to the core member for permitting expansion of the valve anchor.
Separability of proximal and distal enclosures for compressing valve frame portions
The device includes a distal carrier assembly comprising a distal enclosure and a proximal enclosure, where the distal enclosure is coupled to the core member and includes a distal lumen configured to receive a distal portion of the valve frame within the distal lumen in a compressed configuration, and the proximal enclosure is coupled to the core member proximal to the distal enclosure and includes a proximal lumen configured to receive a proximal portion of the valve frame within the proximal lumen in a compressed configuration, with the proximal enclosure separable relative to the distal enclosure.
Spring-biased plunger mechanism to urge the valve frame out of the distal lumen
The device includes a plunger mechanism and biasing means disposed within the distal lumen of the distal carrier assembly, the plunger mechanism being moveable between a distal position and a proximal position within the distal lumen, and biased toward the proximal position by the biasing means for urging the valve frame out of the distal lumen.
Grasper components engaging the valve anchor for permitting expansion
The device includes a plurality of grasper components disposed within the sheath component and extending along the elongate core member, wherein a distal end of the plurality of grasper components is configured to each engage with the valve anchor for permitting expansion of the valve anchor.
Separate distal hub aligning grasper distal ends in a common plane during sheath bending
The device includes a distal hub separate from the plurality of grasper components and disposed near a distal end of the elongate core member, the distal hub coupled to the plurality of grasper components to align each of the distal ends of the plurality of grasper components in a common plane as the sheath component is bent, wherein the distal hub is bonded to a tubular enclosure of each of the plurality of grasper components.
Overall, the claims cover compression and deployment mechanics through separable proximal and distal enclosures and a biasing means with a plunger mechanism to urge the valve frame out of a distal lumen, together with anchoring expansion support using grasper components and a separate distal hub that aligns grasper distal ends in a common plane as the sheath component is bent.
Stated Advantages
Improved maneuverability.
Reduced passing profile.
Enhanced positional precision.
Reduced migration and paravalvular leakage.
Minimized vascular trauma and coronary blockage risk.
Documented Applications
Transcatheter delivery of a heart valve prosthesis (TAVI/TAVR), including transfemoral retrograde approach, using the described valve prosthesis delivery device.
Interested in licensing this patent?