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-11179156-B2
Publication Date
2021-11-23
Expiration Date
2036-09-15
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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 provides devices and methods for transcatheter Glenn shunt and Fontan systems, allowing for nonsurgical, percutaneous extra-anatomic bypass between two adjacent vessels. The disclosed radially self-expanding endograft prosthesis includes a distal flange configured to flip generally perpendicularly to help 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 for flexibility, and a proximal segment with adjacent undulating strut rings to seat against a vessel wall. The prosthesis also includes features such as a tether to facilitate collapsing and removal, and a delivery system with radiopaque markers for visualization and precise placement.
The problem solved by the invention arises from the burden and invasiveness of current surgical procedures for children born with single ventricle physiology (SVP), a form of cyanotic congenital heart disease. Traditional management requires a series of staged open-heart surgeries, including the Norwood Procedure, bi-directional Glenn operation, and Fontan procedure. These surgical interventions are invasive, traumatic, and entail significant recuperation times and burdens on young patients, with no commercial nonsurgical alternatives available for performing cavopulmonary anastomosis.
The invention addresses this unmet need by providing a purpose-built, transcatheter cavopulmonary bypass endograft prosthesis that can be delivered percutaneously, reducing the burden of surgery, shortening recovery, and lowering costs. The device enables an interventional cardiologist to create a shunt between the Superior Vena Cava and the main pulmonary artery via a nonsurgical approach, offering an urgently needed alternative to staged surgeries and heart transplantation for children with congenital heart failure.
Claims Coverage
The claims include one independent method claim describing the inventive features of a transcatheter method for installing a tubular prosthesis to effectuate a cavopulmonary bypass.
Method for installing a tubular prosthesis with a self-expanding distal annular flange
The method includes providing a prosthesis comprising a distal annular flange that helps seat the prosthesis when pulled proximally, a distal tubular segment with stiffness sufficient to maintain a puncture open through a first vessel wall, and a proximal tubular segment sufficiently stiff to seat and urge against a second vessel wall; collapsing the prosthesis onto a delivery system; delivering the distal end of the delivery system to an opening in a native lumenal vessel wall; deploying the distal annular flange inside the native vessel; and detensioning a tether directed through the proximal end of the prosthesis to open the proximal end.
The independent claim covers the inventive method of deploying a specifically designed self-expanding tubular prosthesis featuring a distal annular flange for seating, a stiff distal segment for maintaining vessel wall puncture patency, and a proximal segment for vessel wall apposition, with control via a tether and deployment through a delivery system.
Stated Advantages
Provides a safe, less burdensome, and effective alternative to open heart surgery for congenital heart failure patients.
Enables a nonsurgical transcatheter intervention limiting the burden of surgery on infants.
Reduces recuperation time and overall treatment cost compared to staged surgical procedures.
Offers a purpose-built device for cavopulmonary anastomosis where no commercial alternatives exist.
Documented Applications
Percutaneous transcatheter Glenn procedure to create a shunt between the Superior Vena Cava and main pulmonary artery.
Percutaneous transcatheter Fontan procedure connecting inferior vena cava through the ventricle to the main pulmonary artery.
Formation of extra-anatomic bypass between two adjacent vessels in children with congenital heart disease.
A shunt from the descending aorta to the main pulmonary artery to decompress the aorta.
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