Devices and methods for closure of transvascular or transcameral access ports
Inventors
Rafiee, Nasser • MacDonald, Stuart • Lederman, Robert J. • Rogers, Toby • Busold, Rany • Rafiee, Koosha
Assignees
Transmural Systems LLC • US Department of Health and Human Services
Publication Number
US-10058315-B2
Publication Date
2018-08-28
Expiration Date
2035-03-26
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Abstract
The present disclosure provides a variety of prostheses, delivery systems and techniques to facilitate closure of transvascular or transcameral access ports. Various embodiments of prostheses are provided including a plurality of radially expandable mesh discs filled with material to facilitate coagulation and to reduce or stop leakage from punctures in vessel walls.
Core Innovation
The invention provides various prostheses, delivery systems, and techniques designed to facilitate closure of transvascular or transcameral access ports. The prostheses typically include radially expandable mesh discs filled with material to encourage coagulation and to reduce or stop leakage from vessel wall punctures. The devices can self-expand into at least one or multiple discs, joined by a neck region, and are delivered via specialized catheters configured for cardiovascular applications.
The background describes challenges with current transcatheter procedures, particularly the limitations of existing vascular occluders which often require foregoing guidewire access and suffer from inadequate hemostasis. Specifically, the closure of 'caval-aortic' access ports used for transcatheter aortic valve replacement (TAVR) has been problematic, with conventional devices being imperfectly suited for this new access and lacking hemostatic efficacy and continuous wire access.
The invention addresses problems such as variable distances between aortic and caval access points by proposing telescopic designs, and inadequate hemostasis by utilizing 'billowing' nitinol weave and multiple discs to occlude vascular rents. The prostheses include radially expandable mesh bodies with internal resilient members, such as coil springs, that cause expansion radially and shortening axially. Additional features include fabric lining to promote coagulation, articulated delivery systems with bevelled and steerable tips, and deployable wing-like struts to enhance fixation and collapsibility. Alternative embodiments include inflatable bioresorbable bodies capable of radial expansion via fluid inflation, enabling sealing of vascular openings with retrievability and repositionability.
Claims Coverage
The patent contains one independent prosthesis claim and one independent delivery system claim, covering the axially telescoping prosthesis and the system for delivering the prosthesis respectively. The proposed features focus on the structural configuration of the prosthesis and functional aspects of its delivery and deployment.
Axially telescoping prosthesis with discrete radially expandable braided mesh bodies
The prosthesis comprises multiple discrete radially expandable braided mesh bodies forming at least one disc each, which are axially displaceable relative to one another. A structurally distinct resilient member extends co-axially through the central region of the mesh bodies, joining them and allowing telescopic displacement along the prosthesis axis by stretching or relaxing the member. Relaxation causes axial shortening and radial expansion for sealing.
Inclusion of length limiting tethers to control elongation
At least one tether attaches the discrete mesh bodies to prevent the resilient member from elongating beyond a predetermined length, thereby limiting prosthesis extension.
Fabric discs within mesh bodies and tubular fabric neck region
Each radially expandable mesh body includes at least one fabric disc inside to encourage coagulation and sealing. A tubular fabric portion extends proximally from one or more fabric discs into the neck region, enhancing hemostasis and sealing.
Resilient coil spring providing collapse and pull-through prevention
The resilient member is a coil spring surrounded by fabric configured to axially collapse the prosthesis and radially expand the mesh bodies. The coil spring prevents axial pull-through of the prosthesis once deployed, and its unconstrained radial expansion of the neck region aids hemostasis.
Adjustable lumen and self-sealing function
The prosthesis defines a lumen along its length through the mesh bodies, acting as an adjustable shunt with variable length for connecting lumens or sealing holes, particularly for vascular or cardiac defects.
Delivery system with nested tubular members and articulated distal portion
The delivery system includes an outer tubular sheath, a slidably disposed intermediate tubular member with a flexible distal portion extending beyond the sheath, and an inner elongate member for pushing against the prosthesis. The prosthesis is removably mounted on the intermediate member's distal end. Longitudinal stretching of the prosthesis by advancing the inner member causes radial collapse for retraction into the sheath.
Bevelled distal end with radiopaque marker for alignment
The outer tubular sheath distal end is cut at an oblique angle with respect to the central axis and includes a radiopaque marker visible fluoroscopically to facilitate accurate alignment and reduce prosthesis canting during implantation.
Flexible distal portion of intermediate tubular member for navigation
The intermediate tubular member's distal portion is flexible and can be deformed into a reverse curved shape inside a patient's lumen to adapt to anatomical angles, improving navigation and positioning during deployment.
Inner elongate member with guidewire lumen and abutment feature
The inner elongate member is preferably tubular to allow passage of a guidewire through its lumen. Its distal end abuts against the prosthesis inner face to form a guidewire lumen through the prosthesis during deployment.
The independent claims define a telescoping prosthesis made of discrete radially expandable braided mesh discs interconnected and axially adjustable via a resilient member to accommodate variable anatomies, with features enhancing sealing, hemostasis, and retrievability. The delivery system claims cover a multi-lumen catheter arrangement with flexible and steerable distal components, a bevelled and radiopaque distal sheath end, and an inner elongate member that enables controlled prosthesis collapse, repositioning, and guidewire access throughout the procedure.
Stated Advantages
Enhanced hemostasis through use of billowing nitinol weave and multiple expandable discs configured to occlude vascular rents.
Capability to accommodate variable anatomical distances between vascular access points using telescoping design of prosthesis.
Retrievability and repositionability of the prosthesis after deployment, enabled by resilient members and delivery system design.
Improved navigation and placement accuracy via bevelled and radiopaque distal tip of the delivery catheter and flexible intermediate tubular member.
Reduction of prosthesis canting and pull-through risk owing to the resilient coil spring and paddle features that aid fixation and sealing.
Documented Applications
Closure of transvascular or transcameral access ports, including iatrogenic fistulas between inferior vena cava and abdominal aorta.
Treatment of cardiovascular defects such as atrial septal defect, ventricular septal defect, and patent ductus arteriosus.
Sealing of access openings formed in vascular or cardiac walls during transcatheter therapeutic procedures, including aortic valve replacement via alternative access routes.
Use in transcardiac applications like sealing openings through the aortic arch or ventricular wall after surgical or catheter-based interventions.
Delivery and closure of large introducer vascular ports to prevent life-threatening vascular complications during transcatheter structural heart procedures.
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