An implantable, autonomously growing medical device is disclosed. The device may have an outer, braided outer element that holds an inner core. Degradation and/or softening of the inner core permits the outer element to elongate, allowing the device to grow with surrounding tissue. The growth profile of the medical device can be controlled by altering the shape/material/cure conditions of the inner core, as well as the geometry of the out element.

A horseshoe-shaped guide catheter for stent angioplasty of the ductus arteriosus in newborn and infants with ductal-dependent cardiopathies, characterized by a long, straight, hollow first section merged at the distal end thereof to a second section formed by a curved portion shaped as a circle section with radius (Ra) of 7.5 mm to 9 mm, arc (b) of 180° to 280° and distance (d) between the tip of the second section and the straight part of the first section without deformations of 7 mm and 15 mm. The angioplasty makes it possible to insert one or more stents that keep the ductus open in extrauterine life, improving survival of the newborn and young infants, allowing weight gain and undergo corrective surgery a few months later with safer and with better outcomes.

Embodiments herein provide an implantable Flow Streamliner for passively regulating blood streams in a TCPC subject. The implantable Flow Streamliner is configured to split a blood stream from an Inferior Vena Cava (IVC) and a blood stream from a Superior Vena Cava (SVC), without a direct collision between the blood streams. Further, the implantable Flow Streamliner is configured to distribute the blood stream from the IVC containing hepatic nutrients in proportion to a Left Pulmonary Artery (LPA) and a Right Pulmonary Artery (RPA). Further, the implantable Flow Streamliner is configured to distribute the blood stream from the SVC in equal proportion to the LPA and the RPA.

Some embodiments are directed to methods for serially expanding an artificial heart valve within a pediatric patient. For example, the artificial heart valve can be implanted into the pediatric patient during a first procedure, and then expanded during a second procedure to accommodate for the pediatric patient's growth. Some embodiments include introducing an expander into the implanted valve when the frame is expanded to a first working diameter, and then actuating the expander to expand the frame to a second working diameter greater than the first working diameter, to accommodate for the pediatric patient's growth.

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.

A growth stent and valve and methods for making and using the same. The growth stent and valve may be delivered to treat early stage congenital lesions, while expanding to adult vessel diameters. In selected embodiments, the growth stent and valve can comprise a frame and may have a covering on some portion to prevent blood flow through a wall of the frame. The growth stent and valve advantageously can maintain radial strength across an entire range of diameters necessary to treat a narrowed lesion from birth and childhood through adulthood as the vessels grow over the lifetime of a 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.

Some embodiments are directed to methods for serially expanding an artificial heart valve within a pediatric patient. For example, the artificial heart valve can be implanted into the pediatric patient during a first procedure, and then expanded during a second procedure to accommodate for the pediatric patient’s growth. Some embodiments include introducing an expander into the implanted valve when the frame is expanded to a first working diameter, and then actuating the expander to expand the frame to a second working diameter greater than the first working diameter, to accommodate for the pediatric patient’s growth.

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.

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.