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.

According to various aspects and embodiments, a growth adaptive expandable stent is provided. The expandable stent includes a stent structure having a cylindrical shape that is self-expanding in a radial direction and includes a plurality of cylindrical rings disposed along a longitudinal axis of the stent structure. The stent structure is configured to exert a continuous outward radial force over time when implanted such that a diameter of the stent structure expands from a first value to a second value that is at least about 1.5 times the first value.

Described herein are artificial valves that have a frame and leaflets that grow or expand with a patient. Upon placing the valve inside the patient, the valve expands as the annulus of the patient expands. The frame of the valve is configured to expand which in turn causes the leaflets to expand (e.g., to grow). The valve includes a thin undulating wire embedded inside the leaflets. As the annulus of the patient grows, the frame expands, and as the frame expands, the leaflets grow. The growth or expansion of the leaflets is configured so that the valve continues to operate properly (e.g., the leaflets continue to coapt) with expansion of the annulus. The change in size of the valve can be configured to accommodate changes in size of the annulus from an infant or child to an adult.

A transcatheter dilatable valve tube prosthesis is provided including a tubular member capable of plastic deformation from a first dimension to a second dimension; a valve component having a plurality of leaflets. The valve component is capable of expansion from the first dimension to the second dimension, and the valve component is secured to an interior portion of the tubular member by an elastomeric glue at two circumferential portions defining an annular cavity therein. An expandable stent is positioned in the annular cavity between the valve component and the tubular member.

According to various aspects and embodiments, a growth adaptive expandable stent is provided. The expandable stent includes a stent structure having a cylindrical shape that is self-expanding in a radial direction and includes a plurality of cylindrical rings disposed along a longitudinal axis of the stent structure. The stent structure is configured to exert a continuous outward radial force over time when implanted such that a diameter of the stent structure expands from a first value to a second value that is at least about 1.5 times the first value.

Systems and methods for the manufacture of an hourglass shaped stent-graft assembly having an hourglass shaped stent, graft layers, and an assembly mandrel having an hourglass shaped mandrel portion. Hourglass shaped stent may have superelastic and self-expanding properties. Hourglass shaped stent may be encapsulated using hourglass shaped mandrel assembly coupled to a dilation mandrel used for depositing graft layers upon hourglass shaped mandrel assembly. Hourglass shaped mandrel assembly may have removably coupled conical portions. The stent-graft assembly may be compressed and heated to form a monolithic layer of biocompatible material. Encapsulated hourglass shaped stents may be used to treat subjects suffering from heart failure by implanting the encapsulated stent securely in the atrial septum to allow blood flow from the left atrium to the right atrium when blood pressure in the left atrium exceeds that on the right atrium. The encapsulated stents may also be used to treat pulmonary hypertension.

An expandable valved conduit for pediatric right ventricular outflow tract (RVOT) reconstruction is disclosed. The valved conduit may provide long-term patency and resistance to thrombosis and stenosis. The valved conduit may enlarge radially and/or longitudinally to accommodate the growing anatomy of the patient. Further, a method is disclosed for the manufacture of the valved conduit based in part on a plastically deformable biocompatible polymer and a computer-optimized valve design developed for such an expandable valved conduit.

Described herein are radially self-expanding stents. The disclosed stents can be used to widen arteries and/or veins of a patient to counteract or combat narrowing of the arteries and/or veins associated with certain congenital diseases, such as aortic coarctation. As an example, the disclosed stents are configured to be placed at or near a narrowed portion of the aorta where the stent produces a radial outward force on the aorta. The radial force produced by the stent widens the aorta and causes the stent to expand with the aorta. The disclosed stents can be crimped to relatively small sizes for placement in small patients (e.g., less than about 10 kg in size) and can be configured to expand to widen the aorta and to accommodate growth in the patient.

Described herein are radially self-expanding stents. The disclosed stents can be used to widen arteries and/or veins of a patient to counteract or combat narrowing of the arteries and/or veins associated with certain congenital diseases, such as aortic coarctation. As an example, the disclosed stents are configured to be placed at or near a narrowed portion of the aorta where the stent produces a radial outward force on the aorta. The radial force produced by the stent widens the aorta and causes the stent to expand with the aorta. The disclosed stents can be crimped to relatively small sizes for placement in small patients (e.g., less than about 10 kg in size) and can be configured to expand to widen the aorta and to accommodate growth in the patient.

Artificial heart valve structures and methods of their fabrication are disclosed. The heart valve structures may be fabricated from a biocompatible polymer and include one or more heart valve leaflet structures incorporated within a conduit. The valve structures may incorporate one or more conduit sinuses, as well as a gap between the lower margin of the valve leaflets and the interior of the conduit. In addition, the valve structures may include one or more valve sinuses created in a space between the valve leaflets and the conduit inner surface. Computational fluid dynamics and mechanical modeling may be used to design the valve leaflets with optimal characteristics. A heart valve structure may also incorporate a biodegradable component to which cells may adhere. The incorporated cells may arise from patient cells migrating to the biodegradable component, or the component may be pre-seeded with cells prior to implantation in a patient.