Devices and methods for effectuating percutaneous Glenn and Fontan procedures
Inventors
Rafiee, Nasser • MacDonald, Stuart • Lederman, Robert J. • Ratnayaka, Kanishka • MACDONALD, Biwei • RAFIEE, Alana
Assignees
Transmural Systems LLC • US Department of Health and Human Services
Publication Number
US-10426482-B2
Publication Date
2019-10-01
Expiration Date
2036-09-15
Interested in licensing this patent?
MTEC can help explore whether this patent might be available for licensing for your application.
Abstract
In some implementations, a radially self-expanding endograft prosthesis is provided that includes (i) distal flange that is self-expanding and configured to flip generally perpendicularly with respect to a body of the prosthesis to help seat the prosthesis against a tissue wall, (ii) a distal segment extending proximally from the distal flange that has sufficient stiffness to maintain a puncture open that is formed through a vessel wall (iii) a compliant middle segment extending proximally from the distal segment, the middle segment being more compliant than the distal segment, and having independently movable undulating strut rings attached to a tubular fabric, the combined structure providing flexibility and compliance to allow for full patency while flexed, the segment being configured to accommodate up to a 90 degree bend, (iv) a proximal segment having a plurality of adjacent undulating strut rings that are connected to each other.
Core Innovation
The invention disclosed in this patent relates to a radially self-expanding endograft prosthesis designed for percutaneous transcatheter Glenn shunt and Fontan procedures. This prosthesis includes distinct segments: a self-expanding distal flange configured to flip generally perpendicularly to seat the prosthesis against a tissue wall, a distal segment with sufficient stiffness to maintain a puncture open through a vessel wall, a compliant middle segment with independently movable undulating strut rings attached to tubular fabric allowing flexibility and compliance to accommodate up to a 90 degree bends, and a proximal segment with multiple adjacent connected undulating strut rings designed to seat within and urge against a vessel wall. The proximal end also includes openings for a tether that collapses the prosthesis radially inward when tensioned.
The problem addressed by the invention arises from children born with single ventricle physiology (SVP), a cyanotic congenital heart disease that requires multiple invasive and traumatic staged surgical procedures such as the Norwood Procedure, Bi-directional Glenn operation, and Fontan procedure. These surgeries are burdensome, require significant recovery, and impose excessive physical and financial strain on infants. Currently, no commercial device exists to facilitate a nonsurgical, percutaneous cavopulmonary anastomosis.
This disclosure proposes a transcatheter cavopulmonary bypass endograft (TCBE) that enables an interventional cardiologist to create shunts between vessels such as the Superior Vena Cava (SVC) and the main pulmonary artery (MPA) via a nonsurgical catheter-based approach. The prosthesis is designed with multiple segments providing a combination of stiffness and compliance to maintain vessel openings while accommodating vessel curvature. The delivery system is designed with features such as radiopaque markers and an atraumatic tip for precise navigation and deployment. The prosthesis includes features such as flanges at one or both ends for secure seating, fenestrations for fluid leakage, and adjustable length configurations to adapt to different anatomical requirements.
Claims Coverage
The patent includes one main independent claim directed to a reinforced endograft shunt prosthesis and one independent claim regarding a delivery system incorporating the prosthesis, describing several inventive features.
Reinforced endograft shunt prosthesis multi-segment design
The prosthesis comprises: a distal flange that aids seating when pulled proximally; a distal segment with sufficient stiffness to maintain a puncture through a vessel wall open; a more compliant middle segment with undulating strut rings attached to tubular fabric to allow full patency while flexed and to accommodate up to a 90 degree bend; a proximal segment having adjacent connected undulating strut rings sufficiently stiff to seat within and push against a vessel wall; and an undulating proximal end with a tether threaded through openings to collapse the prosthesis radially inward when tensioned.
Prosthesis flange and fenestration features
The distal flange has a multi-pointed star shape and self-expands by flipping from a position generally parallel to the prosthesis axis to one generally perpendicular or at an acute angle (70 to 90 degrees) to the prosthesis, enhancing seating against the vessel wall. The prosthesis can include fenestrations in its sidewall to allow bodily fluid leakage, and may include inner and outer tubular fabric layers.
Proximal segment and length adjustment
The proximal segment can be flared or bell-shaped to improve apposition against a vessel wall. The prosthesis can include a flange at its proximal end, with both flanged ends configured to seat within respective body lumens. The prosthesis can have an adjustable telescoping length feature, maintaining substantially unchanged inside diameter during length adjustment. Tubular structural regions at each flanged end may be structurally joined by an elastic member to maintain tension and seating.
Delivery system with visualization and deployment features
The delivery system includes the prosthesis mounted on a longitudinal inner member and inside a retractable sheath. The tether ends extend proximally outside the delivery system. It incorporates first and second radiopaque marker sets near the distal end of the system to indicate and register relative positions of the prosthesis during deployment. The distal atraumatic tip made of iron oxide facilitates MRI or other imaging navigation. The markers indicate when the distal flange is properly configured to pull against the inner face of a vessel wall.
The independent claims cover a multi-segment radially self-expanding endograft prosthesis with specialized distal and proximal flanges, flexible and stiff segments designed for vessel wall seating and patency, fenestrations, adjustable length, and a delivery system with advanced visualization and tether mechanisms to facilitate minimally invasive Glenn and Fontan procedures.
Stated Advantages
Provides a safe, less-burdensome, and effective alternative to open heart surgery for children with congenital heart failure.
Limits the burden of multiple staged palliative surgeries and potentially avoids heart transplantation or lifelong medication intake.
Offers a nonsurgical transcatheter intervention that reduces recovery time and cost compared to conventional surgery.
The prosthesis design accommodates vessel curvature up to 90 degrees while maintaining vessel patency.
The delivery system includes radiopaque markers and MRI-compatible features for precise navigation and deployment.
Documented Applications
Percutaneous transcatheter Glenn procedure connecting the superior vena cava (SVC) to the main pulmonary artery (MPA).
Percutaneous transcatheter Fontan procedure connecting the inferior vena cava (IVC) to the main pulmonary artery (MPA).
Formation of shunts between two adjacent vessels or body lumens to facilitate extra-anatomic bypass.
Potential use to form a shunt from the descending aorta to the main pulmonary artery for aortic decompression.
Interested in licensing this patent?