Transvascular and transcameral device access and closure
Inventors
Lederman, Robert J. • Kocaturk, Ozgur
Assignees
US Department of Health and Human Services
Publication Number
US-10376253-B2
Publication Date
2019-08-13
Expiration Date
2033-11-27
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Abstract
Transcatheter methods are disclosed for introducing a large transcatheter implant or other device into an artery from an adjacent vein, for example from the inferior vena cava into the abdominal aorta. Such an access route can be formed by direct puncture through the adjoining vessels. In addition, methods and devices are also disclosed for closing arteriovenous fistulas or other cardiovascular passageways.
Core Innovation
The invention discloses transcatheter methods for introducing large transcatheter implants or other devices into an artery from an adjacent vein, such as accessing the abdominal aorta from the inferior vena cava. This access route is formed by direct puncture through adjoining vessels, providing an alternative to traditional femoral artery access for large devices. Furthermore, the invention encompasses methods and devices for closing arteriovenous fistulas or other cardiovascular passageways created by such access or other conditions.
The problem addressed is the difficulty and risk associated with transcatheter aortic and left heart procedures performed via the femoral artery, which can be precluded or complicated by small artery caliber or intravascular disease. Large introducer sheaths placed in the femoral artery pose a life-threatening risk of vascular complications. The invention aims to provide a safer, non-surgical access route using the larger and more compliant iliofemoral veins, thereby reducing risks associated with arterial access.
The disclosed methods involve advancing a puncture device through a femoral vein to a venous crossing site and puncturing both the venous wall and an adjacent arterial wall to form an access tract. A catheter is then advanced through this tract to deliver cardiovascular devices such as a prosthetic heart valve or aortic endograft into the artery. After device delivery, occlusion devices are introduced to close the access tract or fistula. The occlusion devices are radially compressible for delivery and radially expandable for implantation, with features ensuring sealing, retention, and adaptability to variations in vessel anatomy and fistula configuration.
Claims Coverage
The patent includes one independent claim with multiple inventive features covering an occlusion system and related delivery system for transcatheter closure of cardiovascular passageways.
Occlusion implant with radially expandable end portions and central neck
An implant resiliently deformable for transcatheter delivery, having proximal and distal end portions and an intermediate neck; the distal end forms a radially enlarged skirt that contacts and blocks blood flow at one end of the passageway, with a longitudinal guidewire channel that is occluded when the guidewire is absent.
Detachable delivery system with pivoting attachment and torque transfer
A detachable delivery system including an attachment member and delivery shaft with aligned guidewire channels; the delivery shaft has a distal ball joint engaging the attachment member, allowing pivot in only one plane during implant positioning and transfer of torque for selective attachment and detachment.
The independent claim covers a transcatheter occlusion implant with specialized structural features for sealing and retention within cardiovascular passageways, combined with a sophisticated detachable delivery system that enables precise implant positioning and secure attachment/detachment.
Stated Advantages
Provides a non-surgical alternative for large transcatheter device introduction into arteries via adjacent veins, reducing vascular complications associated with femoral artery access.
Venous access via larger, more compliant veins reduces risk of hemorrhage due to lower pressure and venous decompression.
Occlusion devices with radially expandable end portions and adjustable necks provide effective sealing and retention across variable cardiovascular passageways.
The detachable delivery system with pivoting and torque transmission features enhances precise device placement and secure release.
Adjustable and articulable occlusion devices accommodate anatomical variations and movement between vessels, improving long-term sealing and device stability.
Documented Applications
Transcatheter delivery of large cardiovascular devices such as prosthetic heart valves, aortic endografts, left ventricular assist devices, and cardiopulmonary bypass devices via venous access crossing into arteries.
Closure of arteriovenous fistulas or access tracts formed between adjacent veins and arteries, including caval-aortic fistulas formed by direct puncture methods.
Closure of other cardiovascular passageways such as ventricular or atrial septal holes, transthoracic ports into heart chambers, paravalvular leaks, coronary-cameral fistulas, fistulas between aorta and heart chambers, and iatrogenic injuries or holes in great vessels or heart walls.
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