A prosthetic heart valve assembly includes a self-expandable stent having an inlet end and an outlet end and a passageway extending therethrough. The stent includes a plurality of rows of prongs on the outer surface of the stent. A valve portion comprising a plurality of leaflets is positioned within the passageway for permitting blood to flow through the passageway from the inlet end to the outlet end while blocking flow in the opposite direction. The stent further includes a flared upper portion shaped for placement along a supra-annular surface of an annulus for preventing downward migration of the prosthetic valve assembly into a ventricle. Each of the prongs has a tip pointing toward the inlet end for penetrating surrounding tissue and preventing upward migration of the prosthetic heart valve assembly toward an atrium.

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.

Methods for the conditioning of bioprosthetic material employ bovine pericardial membrane. A laser directed at the fibrous surface of the membrane and moved relative thereto reduces the thickness of the membrane to a specific uniform thickness and smooths the surface. The wavelength, power and pulse rate of the laser are selected which will smooth the fibrous surface as well as ablate the surface to the appropriate thickness. Alternatively, a dermatome is used to remove a layer of material from the fibrous surface of the membrane. Thinning may also employ compression. Stepwise compression with cross-linking to stabilize the membrane is used to avoid damaging the membrane through inelastic compression. Rather, the membrane is bound in the elastic compressed state through addition cross-linking. The foregoing several thinning techniques may be employed together to achieve strong thin membranes.

A method for preserving and reducing the immunogenicity of a tissue, the method including obtaining a first tissue, the first tissue being a wild type tissue or genetically modified tissue; forming a second tissue by immersing the first tissue in a first solution having a cryoprotectant concentration of at least about 75% by weight for at least one hour to kill and lyse the cells of the first tissue; forming a third tissue by removing residual cell materials of the second tissue, the residual cell materials of the second tissue being removed by subjecting the second tissue to decellularization in a bioreactor; and subjecting the third tissue to ice-free cryopreservation.

The present application provides a vascular bioprosthetic graft having an internal diameter of about 3 mm for performing coronary artery bypass grafting surgery. The present application also provides a method for manufacturing the vascular bioprosthetic graft. The vascular bioprosthetic graft is obtained from a xenogeneic venous vessel from the rectum, such as a xenogeneic cranio-rectal vein.

A bioprosthetic tissue having a reduced propensity to calcify in vivo, the bioprosthetic tissue. The bioprosthetic tissue comprises an aldehyde cross-linked and stressed bioprosthetic tissue comprising exposed calcium, phosphate or immunogenic binding sites that have been reacted with a calcification mitigant. The bioprosthetic tissue has a reduced propensity to calcify in vivo as compared to aldehyde cross-linked bioprosthetic tissue that has not been stressed and reacted with the calcification mitigant.

The growth factor profile, connective tissue matrix constituents, and immunoprivileged status of urodele extracellular matrix (ECM) and accompanying cutaneous tissue, plus the presence of antimicrobial peptides there, render urodele-derived tissue an ideal source for biological scaffolds for xenotransplantation. In particular, a biological scaffold biomaterial can be obtained by a process that entails (A) obtaining a tissue sample from a urodele, where the tissue comprises ECM, inclusive of the basement membrane, and (B) subjecting the tissue sample to a decellularization process that maintains the structural and functional integrity of the extracellular matrix, by virtue of retaining its fibrous and on-fibrous proteins, glycoaminoglycans (GAGs) and proteoglycans, while removing sufficient cellular components of the sample to reduce or eliminate antigenicity and immunogenicity for xenograft purposes. The resultant urodele-derived biomaterial can be used to enhance restoration of skin homeostasis, to reduce the severity, durations and associated damage caused by post-surgical inflammation, and to promote progression of natural healing and regeneration processes. In addition, the biomaterial promotes the formation of remodeled tissue that is comparable in quality, function, and compliance to undamaged human tissue.

A method or apparatus for creating a three-dimensional tissue construct of a desired shape for repair or replacement of a portion of an organism. The method may comprise injecting at least one biomaterial in a three-dimensional pattern into a first material such that the at least one biomaterial is held in the desired shape of the tissue construct by the first material. The apparatus may comprise an injector configured to inject at least one biomaterial in a three-dimensional pattern into a first material such that the at least one biomaterial is held in the desired shape of the tissue construct by the first material. The first material may comprise a yield stress material, which may be a material exhibiting Herschel-Bulkley behavior. The tissue construct may have a smallest feature size of ten micrometers or less.

Tissue prostheses having a base structure and a physiological sensor system. The tissue prostheses are adapted and configured to induce remodeling of damaged tissue and regeneration of new tissue and concurrently detect and monitor physiological characteristics when implanted in the subject.

The present invention provides a transapical implantable mitral valve device, which includes an outer valve stent comprising an outer valve stent body that is composed of a plurality of first structure units arranged in the circumferential direction and an anchoring unit that is disposed on the outer valve stent body for anchoring the mitral valve device in a human body, at least one of an inner surface and an outer surface of the outer valve stent body being covered with an outer skirt; an inner valve stent disposed inside the outer valve stent and interconnected with the outer valve stent, a cavity being formed between the outer valve stent and the inner valve stent; and a valve leaflet structure disposed in the inner valve stent to form a prosthetic valve.