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-10045765-B2
Publication Date
2018-08-14
Expiration Date
2035-03-26
Interested in licensing this patent?
MTEC can help explore whether this patent might be available for licensing for your application.
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 discs that can be filled with material to facilitate coagulation and to reduce or stop leakage from punctures in vessel walls.
Core Innovation
The invention provides a variety of prostheses, delivery systems, and techniques to facilitate closure of transvascular or transcameral access ports. The prostheses include a plurality of radially expandable discs that can be filled with material to promote coagulation and reduce or stop leakage from punctures in vessel walls.
The problem being solved arises from complications in transcatheter procedures, such as inadequate hemostasis, inability to maintain uninterrupted guidewire access, and imperfect fit of existing vascular occluder devices when closing access ports—particularly caval-aortic iatrogenic fistulas created by transcatheter devices between the inferior vena cava and the abdominal aorta. Further problems include difficulty in arterial access due to vessel size or disease, life-threatening vascular complications at femoral artery access, and the need for alternative transcatheter approaches to the heart.
The disclosure addresses these problems by providing prostheses with radially expandable braided mesh bodies and resilient members, such as coil springs, that cause the prostheses to shorten axially and expand radially to prevent pull-through. Features include paddles extending beyond the distal disc periphery to aid in seating and resisting pullout, as well as telescoping designs allowing adjustment to variable distances between access points. Delivery systems include multi-lumen flexible tubular members with bevelled tips and radiopaque markers to reduce canting and enhance deployment precision. The prostheses enable deployment, retrieval, repositioning, and hemostasis in vascular or cardiac walls, with materials and construction enhancing tissue ingrowth and coagulation.
Claims Coverage
The claims include multiple independent claims describing prostheses with radially expandable discs and associated delivery systems, with inventive features focusing on structural design, materials, and delivery methods.
Paddle extending beyond distal disc to facilitate positioning and pullout resistance
The prosthesis includes a radially expandable distal disc with a radially outwardly extending paddle attached. The paddle extends beyond the disc's outer circumference and is configured to seat the prosthesis in a lumenal wall opening and prevent pull-through.
Resilient member causing axial shortening and radial expansion
A resilient member distinct from the braided mesh body is attached proximally and distally and configured to cause the prosthesis to shorten axially and expand radially when relaxed, cooperating with the paddle to prevent pull-through of the prosthesis through a lumen wall hole.
Outer annular fabric section joining proximal and distal discs and surrounding resilient member
An outer annular fabric section extends between and joins the distal and proximal expandable discs, surrounding the resilient member in the neck region and extending to cover inwardly facing faces of discs to facilitate hemostasis and tissue ingrowth.
Delivery system with multi-lumen tubular members and bevelled tip with radiopaque marker
A delivery system includes an outer tubular member with a distal end cut obliquely and marked radiopaque to reduce canting, an intermediate tubular member with a flexible distal portion allowing reverse curved geometry, and an inner elongate member permitting a guidewire to pass. The delivery system allows longitudinal stretching of the prosthesis to radially collapse it for withdrawal into the sheath.
Telescoping radially expandable braided mesh prosthesis with resilient member and length limiting tether
A prosthesis having multiple radially expandable braided mesh bodies connected by mesh and a resilient central member configured to shorten axially and expand radially when relaxed, with tethers to limit extension length. The prosthesis includes an outer fabric covering and defines a lumen through its length to act as an adjustable shunt.
Coil spring with variable diameter sections to prevent exit and facilitate sealing
A tension coil spring connects proximal and distal discs and causes axial shortening and radial expansion of the prosthesis. The coil spring has a larger diameter section centrally located to prevent extension through disc openings and to press graft and mesh materials outward to aid sealing.
The claims cover prostheses with expandable discs and resilient members that enable radial expansion and axial shortening for secure placement and hemostasis, with features like paddles and fabric coverings to enhance sealing and tissue ingrowth. Delivery systems facilitate precise deployment, positioning, retrieval, and adjustment, including telescoping designs to accommodate varied anatomical distances.
Stated Advantages
The prosthesis designs provide improved hemostasis at vascular or cardiac access sites.
The resilient member and paddle cooperate to prevent prosthesis pull-through, enhancing safety and retention.
The telescoping prosthesis design accommodates variable distances between anatomical access points, enhancing versatility.
The delivery system's bevelled tip with radiopaque markers reduces canting and facilitates precise alignment during deployment.
The delivery system and prosthesis allow for delivery, full deployment, recapturing, repositioning, and retrieval, improving procedural control and flexibility.
Fabric coverings on discs and paddles facilitate tissue ingrowth and sealing.
Documented Applications
Closing transvascular or transcameral access ports such as caval-aortic iatrogenic fistulas created by transcatheter devices between the inferior vena cava and the abdominal aorta.
Sealing the arterial and venous walls after transcatheter access procedures, including closure of access tracts formed between veins and arteries.
Closure of congenital heart defects including atrial septal defect, ventricular septal defect, and patent ductus arteriosus.
Closure of iatrogenic heart defects formed from extra-anatomic vascular access ports across left or right ventricular or atrial walls used for structural heart procedures such as valve replacements or repairs.
Use as an adjustable shunt connecting two lumens, with an adjustable lumen along the prosthesis length.
Interested in licensing this patent?