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 replacement heart valve device is disclosed. In some embodiments, the device includes a frame coupled to one or more leaflets that are moveable between open and closed configurations. In some embodiments, the frame comprises at least two frame sections that join at a pair of commissural posts. In some embodiments, the device may be geometrically accommodating to adapt to different vasculature shapes and sizes and/or to be able to change size while implanted within a growing patient.

Disclosed herein is a valve system with an original deployed diameter that is suitable for a child and/or young adult and that can accommodate the patient's growth by a one-time balloon expansion to attain an expanded diameter in that patient. This novel valve addresses an unmet need for children with valve dysfunction and to stop valve-related progressive ventricular dysfunction, and ultimately avoid heart failure in children and young adults.

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

A device for treating regurgitation of a tricuspid valve (4). The device comprises a tricuspid valve plug (21) capable of compressing and expanding and a tricuspid valve plug fixing device used for anchoring the tricuspid valve plug (21) to an orifice of the tricuspid valve (4). The tricuspid valve plug (21) is provided with an inflow end (42, 52) and an opposite outflow end (47, 57), and a prosthetic valve (50, 70) capable of being opened and closed is disposed in the tricuspid valve plug (21). When the tricuspid valve (4) is closed, the prosthetic valve (50, 70) is automatically closed, and when the tricuspid valve (4) is opened, the prosthetic valve (50, 70) is automatically opened. The device for treating regurgitation of a tricuspid valve (4) and the implantation method therefor help to treat regurgitation of a tricuspid valve and do not block the flow of blood in a heart, and the device can be recycled, has the characteristics of high operationality and high safety in minimally-invasive repair, and has high clinical value.

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.

The invention relates to a radially expandable stent (1) comprising a plurality of flexibly interconnected meandering ring elements (2, 3) defining a stent (1) having a proximal and a distal end and a longitudinal axis, wherein said ring elements (2, 3) being arranged side by side along the longitudinal axis of the stent and adjoining ring elements (2, 3) being attached to each other through connection elements (4), wherein connection elements (4) are arranged between at least two adjoining ring elements (2, 3), said connection elements each having at least one expandable expansion element with predetermined breaking point (10), wherein the expansion being possible in the longitudinal and/or transverse direction and the predetermined breaking points (10) only disrupting after the expansion element has been overstretched beyond its maximum expansion point.

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 outer element.

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 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.