Heart valve delivery system and method with rotational alignment
Inventors
Tang, Gilbert H. L. • Bapat, Vinayak • Kodali, Susheel K.
Assignees
Columbia University in the City of New York • Icahn School of Medicine at Mount Sinai
Publication Number
US-12016775-B2
Publication Date
2024-06-25
Expiration Date
2039-09-09
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Abstract
A delivery system for a transcatheter heart valve (THV) to a subject is provided, the delivery system includes a delivery catheter housing the THV therein; an elongated member for receiving the THV thereon and having an accessory extending from the distal portion thereof, the accessory comprising a plurality of components for alignment with commissures of the THV during delivery of the THV, and a rotational member connected to the elongated member to rotate the accessory and THV together to align with a native or bioprosthetic valve commissure or valve leaflet at a desired angle.
Core Innovation
The invention relates to a delivery system and method for implantation of a transcatheter heart valve (THV) with the capability to align the prosthetic valve commissures precisely to the native or bioprosthetic valve commissures or valve leaflets. The delivery system includes a delivery catheter housing the THV and an elongated member with an accessory extending from its distal portion. This accessory comprises radially outwardly extending projections that align with commissures of the native or bioprosthetic valve during delivery, and a rotational member connected to the elongated member to rotate the accessory and THV together, thus allowing the THV to be positioned at a desired angle relative to the native valve anatomy.
The problem being solved is the lack of a predictable and consistent method for aligning THV neo-commissures with native or bioprosthetic valve commissures during transcatheter implantation. This misalignment can impair valve function, durability, and complicate coronary access after THV placement. Specifically, difficulties in coronary artery reaccess after TAVR due to improper commissural alignment represent significant clinical challenges with increased risks during interventions. Current delivery systems do not enable the rotational alignment necessary to optimize the anatomical and functional outcome after THV implantation.
The invention further addresses the need for a delivery system that can independently and precisely manipulate the accessory projections for atraumatic alignment of the THV, allowing engagement with native or prosthetic valve structures across a range of valve types (aortic, mitral, tricuspid). The system supports retractable and extendable accessory projections that are radiopaque and echogenic to aid visualization and rotational alignment under imaging. It also facilitates repositioning or recapturing of the THV while maintaining or restoring alignment via independent rotation of the accessory, improving implantation accuracy and post-deployment valve function.
Claims Coverage
The patent includes nine independent claims presenting inventive features related to the medical device and its method for delivering a transcatheter heart valve with alignment capability.
Accessory with radially outwardly extending projections for commissural alignment
The device includes an accessory extending from a distal portion of an elongated member with multiple radially outwardly extending projections spaced to align with leaflets or commissures of native or bioprosthetic valves. These projections are disposed distally and spaced apart from the THV during delivery to achieve desired angular alignment.
Rotational member to rotate accessory and THV in unison
A rotational member connected to the elongated member rotates the accessory and THV together, enabling alignment of the THV commissures with native or bioprosthetic valve commissures or valve leaflets at a desired angle.
Independent rotatability of delivery catheter and accessory
The delivery catheter housing the THV and the accessory are independently rotatable, allowing fine control and repositioning of the THV and accessory during delivery.
Projections with independent movement and compression capability
Projections can extend radially outward and be compressed within the delivery catheter during delivery. Each projection can be moved independently, including extend/retract functionality to conform to valve anatomy.
Projection embodiments as atraumatic filamentous or loop-shaped structures
Projections can be designed as atraumatic filamentous projections or loop-shaped projections to safely interact with native valve tissue.
Accessory with extendable and retractable projections
Projections are configured to extend from the elongated member and retract within the elongated member, supporting atraumatic navigation and positioning.
Method for THV delivery with accessory extension, rotation, and deployment
The method involves providing an elongated member with accessory projections extending from its distal portion, deploying the member and THV, extending projections, rotating the accessory to align the THV with native or bioprosthetic valve commissures or leaflets at a desired angle, and expanding the THV at the valve location.
Method including compressing and advancing projections from a compressed configuration
Prior to deployment, projections are compressed within the delivery catheter and subsequently advanced to a radially outward configuration during the procedure.
Method adaptation for delivery to various heart valves
The method accommodates delivery and alignment of the THV at the aortic, mitral, or tricuspid valves.
The claims comprehensively cover a delivery system comprising an accessory with radially outwardly extending projections and an associated rotational member to achieve precise angular alignment of a THV with native or bioprosthetic valve commissures or leaflets during delivery. The inventive features include accessory independent rotation, extension and retraction of projections, and method steps for alignment and deployment applicable to multiple heart valve positions.
Stated Advantages
Provides consistent and predictable alignment of transcatheter heart valve commissures with native or bioprosthetic valve commissures, improving valve function and durability.
Facilitates easier and more reliable coronary artery access after THV implantation, reducing risks during diagnostic and therapeutic coronary interventions.
Allows atraumatic navigation and positioning via compressible, extendable, and retractable accessory projections, minimizing tissue injury.
Enables independent rotation of accessory and delivery catheter for fine control and repositioning during deployment.
Supports visualization under fluoroscopy and echocardiography through radiopaque and echogenic components, enhancing procedural accuracy.
Can be applied to multiple heart valves (aortic, mitral, tricuspid), extending the utility of the delivery system across various valve replacement procedures.
Documented Applications
Delivery and implantation of transcatheter heart valves in native and bioprosthetic aortic valves to improve commissural alignment and coronary access.
Delivery and implantation of transcatheter heart valves in native and bioprosthetic mitral valves with alignment to commissures and posterior annulus to improve valve function.
Delivery and implantation of transcatheter heart valves in native or bioprosthetic tricuspid valves, with accessory component designs adapted to tricuspid anatomy.
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