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.

Various features and associated advantages are described for diametrically adjustable support structures, adjustable valve structures, removable/replaceable valve structures, and associated systems and methods. Although some examples are directed toward prosthetic valve that is a conduit having a valve structure, or a “valved conduit” (e.g., used to replace a pulmonary valve and a portion of the corresponding pulmonary artery or an aortic valve and the aortic root), and other examples are directed toward prosthetic valves implanted native valve orifices (e.g., to replace an aortic or mitral valve), the features and advantages of the structures associated with those examples are interchangeable regardless of a particular application for which the examples are described.

The devices and methods of this disclosure relate to a heart valve prosthesis that is configured to be implanted within a native heart valve having a smaller perimeter annuli with a generally elliptical shape.

Implantable devices including conduits that have markings along the length of the conduit are described herein.

A gradually-expandable stent includes a base ring completely encircling a central valve-accepting area. A plurality of uprights is provided. Each upright includes two longitudinally extending upright struts. Each upright strut has a strut base directly connected to the base ring and a strut tip directly attached to the other strut tip of the upright strut at a rounded upright apex. The upright apex is longitudinally spaced from the base ring. At least one expansion feature is associated with the base ring and gradually expands to enlarge the central valve-accepting area toward a maximum valve-accepting area responsive to growth of the patient over an extended dwell time.

Various features and associated advantages are described for diametrically adjustable support structures, adjustable valve structures, removable/replaceable valve structures, and associated systems and methods. Although some examples are directed toward prosthetic valve that is a conduit having a valve structure, or a “valved conduit” (e.g., used to replace a pulmonary valve and a portion of the corresponding pulmonary artery or an aortic valve and the aortic root), and other examples are directed toward prosthetic valves implanted native valve orifices (e.g., to replace an aortic or mitral valve), the features and advantages of the structures associated with those examples are interchangeable regardless of a particular application for which the examples are described.

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.

A diametric adjustment mechanism for an implantable medical device including a track defining a series of diametric setpoints, including a first diametric setpoint and a second diametric setpoint, a rider engaged with the track such that the rider is selectively movable along the track from the first diametric setpoint to the second diametric setpoint and from the second diametric setpoint to the first diametric setpoint, and a biasing element biasing the rider toward the first diametric setpoint when the rider is at the second diametric setpoint.

Implantable devices including conduits that have markings along the length of the conduit are described herein.