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-10568634-B2
Publication Date
2020-02-25
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 as described is a pulmonary artery flow restrictor system comprising a funnel shaped membrane with a proximal base and a restrictive distal opening that is stretchable to larger sizes. Attached to the proximal base of the membrane is a self-expanding frame that secures the membrane within the pulmonary artery. The frame includes arms extending upward over the membrane distal opening and crossing above it to extend into branches of the pulmonary artery, ensuring position and anchoring. The membrane is preferably made of polytetrafluoroethylene (ePTFE) or similar polymer, while the frame may be made of a shape memory alloy such as Nitinol, often in a stent-like structure with spaced upper and lower apexes to which the membrane is secured.
The problem being solved arises from congenital heart disease (CHD) where excessive pulmonary blood flow leads to severe complications and death if untreated. Current surgical treatments, such as pulmonary artery banding or surgical shunts, are effective but have significant drawbacks including distortion of pulmonary arteries, complexity of additional surgeries for adjustment, risks of thrombosis, and the need for invasive operations with lengthy recoveries. There exists a need for a minimally invasive, adjustable, and less traumatic method to restrict pulmonary artery blood flow.
The invention provides such a minimally invasive device and method allowing deployment of the restrictor via catheterization into the pulmonary artery. The restrictive membrane initially provides high flow resistance to palliate severe CHD symptoms, but its restrictive opening can be irreversibly expanded in situ via balloon catheter to adjust the level of blood flow without requiring open surgery. The self-expanding frame maintains position and apposition to the artery wall while accommodating vessel growth, and flexible arms crossing over the distal opening aid anchoring and prevent collapse. This system can be delivered and adjusted incrementally via minimally invasive procedures, potentially reducing surgical trauma, recovery time, and improving long-term outcomes.
Claims Coverage
The patent includes three independent claims detailing the pulmonary artery flow restrictor system, the pulmonary artery flow restrictor with specific frame and membrane features, and the restrictor comprising an irreversibly stretchable membrane and a self-expanding frame.
Funnel shaped membrane with stretchable restrictive distal opening
The system features a funnel shaped membrane having a proximal base and a distal restrictive opening which can be stretched to larger diameters to adjust blood flow.
Self-expanding frame with arms crossing above restrictive opening
A self-expanding frame is attached to the proximal base of the membrane, including arms that extend upward over the membrane and cross above the restrictive distal opening, extending into a branch of the pulmonary artery to secure the membrane.
Membrane made of polymer material
The funnel shaped membrane is made of a polymer, specifically polytetrafluoroethylene (ePTFE), providing suitable physical properties for flow restriction and stretchability.
Frame made of shape memory alloy and stent-like structure
The frame is constructed of a shape memory alloy, such as Nitinol, arranged in a stent-like structure with spaced upper and lower apexes, where the lower apexes are secured to the membrane base, providing self-expanding and securing functions.
Frame includes bent anchoring arms extending over distal opening
The frame includes a plurality of bent anchoring arms that extend upwardly over the restrictive distal opening, each formed from members extending from adjacent upper apexes, enhancing anchoring within pulmonary artery branches.
Transcatheter delivery device with inner guide wire lumen and retractable lumen
The system may include a transcatheter device for delivery, featuring an inner lumen about a guide wire and a retractable lumen retractable relative to the inner lumen. The frame is removably attached to the inner lumen via pins and eyelets, allowing precise placement and deployment.
Pulmonary artery flow restrictor with irreversibly stretchable membrane
The restrictor comprises a membrane made of material irreversibly stretchable via balloon catheter to enlarge the restrictive opening, enabling adjustable blood flow.
The independent claims cover a pulmonary artery flow restrictor system with a funnel shaped, stretchable membrane secured by a self-expanding frame with anchoring arms crossing the restrictive opening, made from polymers and shape memory alloys, and deployable via a transcatheter delivery device, wherein the membrane size can be irreversibly expanded to adjust flow resistance.
Stated Advantages
Provides a minimally invasive surgical device implantable within the pulmonary artery to elevate flow resistance for palliation of congenital heart disease symptoms.
Allows non-surgical adjustment over time of pulmonary blood flow resistance to accommodate patient growth.
Reduces or eliminates recovery time in intensive care and hospital stays compared to conventional pulmonary artery banding requiring open surgery.
Maintains pulmonary artery wall geometry without distortion, unlike conventional pulmonary artery bands or shunts.
Enables deployment and incremental adjustment via catheterization, reducing the need for multiple surgeries.
Can be used to replace a series of operations with a single, planned operation.
Provides a minimally invasive approach potentially useful in areas with limited access to surgery.
Documented Applications
Palliation of children with congenital heart disease by restricting pulmonary artery blood flow in conditions such as ventricular septal defect.
Minimally invasive method to adjust pulmonary blood flow resistance, allowing patients to reach an age at which definitive surgical repair is feasible.
Use in parts of the world where access to surgery is limited or nonexistent as a temporary intervention for pulmonary blood flow control.
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