A system and method are provided for manufacturing filamentous polymer matrices, comprising electrospinning a polymer fiber into a gap between two or more spaced-apart electrodes.

A prosthetic heart valve provided herein can include at least one leaflet having a body portion and two opposite sleeve portions. The body portion can be defined by at least two side edges adjacent each sleeve portion. The at least one leaflet can define at least one notch between at least one of the two side edges and the adjacent sleeve portion, or at least one aperture positioned adjacent at least one side edge and an adjacent sleeve portion.

Disclosed prosthetic valves can comprise a sewing ring configured to secure the valve to an implantation site. Some disclosed valves comprise a resiliently collapsible frame having a neutral configuration and a collapsed deployment configuration. Some disclosed frames can self-expand to the neutral configuration when released from the collapsed deployment configuration. Collapsing a disclosed valve can provide convenient access to the sewing ring, such as for securing the valve to the implantation site, as well as for the insertion of the valve through relatively small surgical incisions.

A polymeric heart valve is disclosed including: a valve body having a central axis having a body fluid pathway extending along the central axis from an inflow end to an outflow end; a flexible stent disposed about an outer circumference of the body and including at least three flexible stent posts each extending in the axial direction to a tip; and at least three flexible leaflets extending from the stent, each of the leaflets having an attached edge defining an attachment curve along the stent extending between a respective pair of stent posts.

A seal member for use with a replacement heart valve implant may include a tubular polymeric seal element configured to be disposed on an outer surface of a replacement heart valve implant, the tubular polymeric seal element defining a central longitudinal axis; and a reinforcement strip fixedly attached to the tubular polymeric seal element proximate a first end of the tubular polymeric seal element, the reinforcement strip extending circumferentially around the central longitudinal axis. The reinforcement strip may include a radiopaque element extending circumferentially around the central longitudinal axis.

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.

Systems and methods for the manufacture of an hourglass shaped stent-graft assembly comprising 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 dilatation 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 device prepares leaflets for cardiovascular valve reconstruction from a pericardial tissue sheet harvested from a patient. A cutter is adapted to cut a predetermined pattern having a selected leaflet size. A tissue marker automatically aligned with the predetermined cutting pattern is configured to mark suture positions on the leaflet in response to placement of the cutter. Cutting of a leaflet from the tissue sheet and marking of suture positions on the leaflet are obtained concurrently. A set of such devices spanning a variety of leaflet sizes may be provided in a kit that results in an ability to quickly obtain a properly sized and marked leaflet for reconstruction.

A prosthetic heart valve includes a stent extending in a longitudinal direction and having a collapsed condition and an expanded condition. The stent includes a plurality of struts forming cells and a plurality of commissure attachment features spaced apart in an annular direction of the stent and extending in a medial direction of the stent. A valve assembly is secured to the commissure attachment features, the valve assembly including a cuff and a plurality of leaflets, each of the leaflets having a free edge and being capable of alternating between an open position and a closed position. A method of manufacturing the prosthetic heart valve is also provided.

A stented valve having at least one leaflet made of pericardium or other material having a relatively thin profile at the annulus. The leaflets are attached via chords to a stent frame, where the chords are positioned to mimic the native valve anatomy and functionality. In particular, the valves of one exemplary embodiment of the invention are sized to replace a mitral valve and therefore the chords are arranged to prevent prolapse of the leaflets into the atrium. The stented valve has a relatively short height at its annulus due to the positioning of the chords. In addition, the stented valve is capable of being crimped to a small enough size that it can be delivered to the implantation site via transcatheter delivery systems and methods.