Transcatheter device and minimally invasive method for constricting and adjusting blood flow through a blood vessel
Inventors
Goldie, James H. • LaBrecque, Brendan • Galea, Anna M • Klem, Eric • Doyle, Thomas • Cohen, Ian • Robinson, Tim
Assignees
Publication Number
US-11980369-B2
Publication Date
2024-05-14
Expiration Date
2037-01-31
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Abstract
A pulmonary artery flow restrictor system includes a funnel shaped membrane with a proximal base and a restrictive distal opening which is stretchable to larger sizes. A self-expanding frame is attached to the proximal base of the membrane for securing the membrane within the pulmonary artery.
Core Innovation
The invention is a pulmonary artery flow restrictor system comprising a funnel shaped membrane with a proximal wide base opening and a restrictive distal opening that can be irreversibly stretched to a larger size. A self-expanding external frame is connected only to the wide base of the membrane to secure the device within the pulmonary artery. The membrane is made of an inelastic material such as expanded polytetrafluoroethylene (ePTFE), while the frame is made of a shape memory alloy like Nitinol. The frame may include arms extending upward over the membrane's distal opening, crossing and anchoring the membrane inside the artery without contacting the artery wall.
The device is deployed minimally invasively via a transcatheter delivery system that includes a retractable sheath and an inner guidewire lumen. The self-expanding frame and membrane are collapsed for delivery and expand to contact the inner wall of the pulmonary artery upon deployment. The size of the restrictive distal opening can be adjusted in situ by balloon catheter dilation, which stretches the membrane material to increase the effective diameter of the opening, allowing for incremental adjustments of blood flow restriction as needed.
The invention addresses the problem of treating congenital heart disease in infants who require restriction of pulmonary blood flow but for whom complete early surgical repair is not possible or ideal. Conventional pulmonary artery banding or surgical shunts cause pulmonary artery distortion and require open surgery for adjustments, leading to complications and recovery issues. The invention provides a minimally invasive alternative that restricts pulmonary artery blood flow without vessel distortion and allows non-surgical adjustments over time to accommodate patient growth.
Claims Coverage
The patent includes one independent claim outlining a pulmonary artery flow restrictor device with several inventive features centered on the membrane design and frame structure.
Funnel shaped membrane with adjustable restrictive opening
A funnel shaped membrane with a wide area base opening and a narrower distal opening to lower blood flow rate. The membrane is made of an inelastic material which is irreversibly stretchable to enlarge the size of the narrower distal opening.
Self-expanding external frame attached to membrane base
A self-expanding external frame connected only to the wide area base of the funnel shaped membrane for positioning the membrane in the pulmonary artery. The frame is configured to contact the inner wall of the pulmonary artery.
The independent claim defines a pulmonary artery flow restrictor device combining a stretchable funnel shaped membrane with a self-expanding frame attached solely to the membrane base to achieve minimally invasive, adjustable blood flow restriction within the pulmonary artery.
Stated Advantages
Provides a minimally invasive surgical device for pulmonary artery flow restriction to palliate congenital heart disease symptoms.
Allows non-surgical, incremental adjustment of blood flow restriction in situ using balloon catheter expansion of the membrane.
Reduces complications and vessel distortion associated with conventional pulmonary artery banding or surgical shunts.
Potentially eliminates or reduces recovery time in intensive care and hospital stay compared to open surgery.
Enables treatment of children in regions with limited access to surgery by replacing multiple operations with a single planned minimally invasive operation.
Maintains membrane position and contact with the pulmonary artery wall while accommodating vessel growth.
Documented Applications
Treatment of congenital heart disease in infants by restricting pulmonary artery blood flow to manage symptoms when complete surgical repair is not feasible.
Minimally invasive palliation of pulmonary blood flow in children with ventricular septal defects or other forms of congenital heart disease.
Adjustment of pulmonary artery flow resistance over time to accommodate patient growth following initial implantation.
Use in parts of the world with limited or no access to surgical intervention, providing a less invasive option for palliation.
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