This invention relates to the design and function of a compressible valve replacement prosthesis, collared or uncollared, which can be deployed into a beating heart without extracorporeal circulation using a transcatheter delivery system. The design as discussed focuses on the deployment of a device via a minimally invasive fashion and by way of example considers a minimally invasive surgical procedure preferably utilizing the intercostal or subxyphoid space for valve introduction. In order to accomplish this, the valve is formed in such a manner that it can be compressed to fit within a delivery system and secondarily ejected from the delivery system into the annulus of a target valve such as a mitral valve or tricuspid valve.

A low pressure gradient prosthetic heart valve for implant in a human. The valve includes a support frame with undulating inflow cusps and outflow commissure posts to which flexible leaflets attach and coapt in a flow area. The commissure posts angle outward in a neutral state to widen the outflow orifice area. Also, the leaflets are designed to fit within the support frame and expand outward in a valve open state without creating a shelf or belly that would restrict flow.

A method for manufacturing a cardiac valve prosthesis is disclosed. This method comprises the following steps: a) shaping human or animal body tissue in a shaping process to give the body tissue a shape of a cardiac valve, and b) fixation and stabilization of the body tissue by a cross-linking agent, thereby preserving the shape given to the body tissue by the shaping process and thus obtaining a cardiac valve prosthesis. Furthermore, a method of implanting an autologous or allogenic cardiac valve prosthesis to an individual in need thereof is disclosed.

There is disclosed a process for treatment to avert enzymatic degradation and tissue degeneration of bovine pericardium tissue, used for making bioprosthesis for implant application, comprising the steps of collecting and harvesting raw bovine pericardial tissue; chemically cross-linking the rinsed tissue to generate fixed tissue; laser cutting said fixed tissue to produce tissue leaflet; chemically treating said tissue leaflet with AAS; chemically sterilising and storing the fixed bovine pericardium tissue to maintain the structural integrity and characteristics; and wherein all the above steps are carried out in a low-oxygen and controlled temperature environment.

Described are embodiments of a multilaminate or multiple layer implantable surgical graft with an illustrative graft comprising a remodelable collagenous sheet material, the graft including one or more interweaving members to stitch together the graft to help prevent the layers from delaminating or separating during handling and the initial stages of remodeling. The interweaving members may comprise lines of suture, thread, individual stitches, strips of material, etc. that are woven through the layers of biomaterial in a desired pattern. In one embodiment, the interweaving members comprise a pharmacologically active substance, such as a drug, growth factors, etc. to elicit a desired biological response in the host tissue. In another embodiment, the graft further comprises a reinforcing material, such as a synthetic mesh, within the layers of remodelable biomaterial and stitched together by one or more interweaving members.

A bioprosthetic valve for repairing a deep venous insufficiency in a subject includes a single leaflet from a xenogeneic heart valve attached at natural margins of attachment to a patch of valve wall tissue. The patch may extend axially above and below the leaflet and circumferentially on either side of the leaflet to provide a region for attaching the patch to a fenestration in a host vein. A bioprosthetic valve may be manufactured by excising a portion of a xenogeneic heart valve including a single leaflet and contiguous wall tissue, and may further comprise shaving off excess leaflet tissue from adjacent leaflets. A method of replacing a malfunctioning venous valve in a subject includes providing a bioprosthetic valve as described above and inserting it to the host vein.

A method for optimizing a shape of a replacement valve leaflet, wherein the shape of the replacement valve leaflet is determined by defining variable parameters of the replacement valve leaflet. The variable parameters may comprise: a valve height; a leaflet coaptation height, a first set of two control points for a first B-spline plane of symmetry; and a second set of two control points for a second B-spline plane tangent to a frame of the valve. The method may further comprise creating iterations of potential shapes of the replacement valve leaflet by changing one or more of the variable parameters using modeling software. The method may also comprise calculating the maximum stresses or strains on each of the potential shapes.

A method for preparing tissue, in particular pericardial tissue, in particular for a heart valve prosthesis, the method including: decellularizing the tissue; subjecting the decellularized tissue to a cross-linking solution including glutaraldehyde; subjecting the tissue to a shape- and structure-stabilizing step, in which the tissue is exposed to a first solution containing glycerol and is exposed to a second solution containing polyethylene glycol; and drying the tissue after the shape- and structure-stabilizing step.

Embodiments herein relate to a method of providing features (LCD, HD, HD_IN, HD_OUT) on an implantable material (ID), the method comprising: providing an implantable material (ID) comprising a decellularized sterilized mammalian tissue having an extracellular matrix, wherein a plurality of interstitial spaces of the extracellular matrix include a solution of one or more polyols, providing one or more features (LCD, HD, HD_IN, HD_OUT) on said implantable material (ID) by laser treatment.

Disclosed herein are compositions and methods to decellularize an isolated organ or portion thereof. Also disclosed herein are compositions and methods for treatment of disease utilizing a decellularized or recellularized organ. Also disclosed herein are methods of improving decellularization and/or recellularization of an isolated organ or portion thereof.