Improvement of RV-PA Conduit
Right ventricle-pulmonary artery/left ventricle-aorta conduit
Congenital heart defects such as hypoplastic left heart syndrome, Tetralogy of Fallot, pulmonary atresia, and pulmonary stenosis restrict the flow of blood from the heart to the lungs, compromising the transport of oxygen throughout the body. Complex operations shortly after birth, including the Rastelli procedure, Ross procedure, and Norwood procedure, are typically required to address these heart conditions. These surgical procedures involve directly connecting the right ventricle to pulmonary artery or left ventricle to aorta, increasing blood flow to the lungs and rest of the body via a conduit sutured at both sites. These open-heart operations are arduous, due to their long duration, as well as delicate, owing to the extremely small size of the newborn patients. Similar procedures to access the heart are utilized in adult populations to redirect blood flow during surgical aortic valve replacement in patients with aortic valve disease and during ventricular assist device placement in patients undergoing a heart transplant. In the United States, more than 80,000 aortic valve replacements are performed per year and approximately 50% of adults undergoing heart transplants receive a ventricular assist device.
In an effort to greatly improve these difficult operations, cardiothoracic surgeon Dr. Randy Stevens of St. Christopher's Hospital for Children has developed a new conduit that can be deployed and connected more easily, requiring less suturing to complete, potentially reducing surgical time by hours. During a Norwood or Rastelli procedure, for example, a needle is inserted into the pericardium and ventricle through which a catheter is inserted to deploy a disk that opens and is flush against the wall of the ventricle, sealing the incision from the inside. As the catheter is removed, a second disk is deployed around the incision on the outside of the pericardium, sealing the incision from the outside. The opening that remains between the disks is connected to a conduit that can be cut to the necessary length and sutured to an opening in the pulmonary artery to complete the connection between the ventricle and artery. In addition to pediatric operations, the device can also be utilized in adult populations, for bypassing leaky valves and in other shunt applications. The same procedure as above would be followed for other operations, to redirect blood flow between two tissues, with two disks sealed around the first tissue and the other side of the conduit sutured to an opening in the second tissue.
Applications
- Conduit to connect blood vessels and heart chambers in surgery to treat congenital heart defects
- Conduit to bypass leaky or occluded valves in the heart or blood vessels
- ECMO arterial or venous cannulation
- Shunt applications
Advantages
- Anchor of conduit is deployed through needle access and seals with discs on both sides of target chamber or vessel without suturing
- Conduit can be cut to desired length in situ after first end is anchored
- Device requires significantly less suturing than current devices, substantially reducing surgical time
- Utility in both pediatric and adult surgical procedures
Intellectual Property and Development Status
Published United States Patent 2021/0077791