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.

An apparatus for in vitro testing of medical device thrombogenicity includes an enclosure; a heating element thermally coupled to the enclosure; and a temperature feedback circuit operably coupled to the heating element and configured to control the heating element to maintain an interior of the enclosure within a preset temperature range. Positive, negative, and intermediate control rods are provided as standards against which to compare a medical device test article. Multiple blood test loops can be established through the enclosure using a common blood supply. The medical device test article can be placed in one of the loops, while the remaining loops can contain controls. Blood can be circulated through the test loops at a flow rate similar to that encountered in vivo, and thrombus formation can be assessed thereafter.

The present invention provides a valve material having synergistic anti-coagulation and anti-calcification functions and a preparation method therefor. The preparation method comprises the following steps: performing glutaraldehyde cross-linking treatment on an animal-derived biological valve material; immersing the treated valve material in a blocking solution containing an amine compound for 0.5-6 h, thereby blocking the remaining aldehyde groups after glutaraldehyde cross-linking; then placing the valve material into a reaction solution containing an anticoagulant and a cross-linking agent, and performing cross-linking treatment for 6-24 h at 4° C.-37° C.; and finally washing and obtaining the valve material, and storing the valve material in a mixed solvent of glutaraldehyde or isopropyl alcohol/glycerol. The method can effectively solve the problem of calcification and thrombosis caused by residual aldehyde groups in a valve material prepared by the existing method. The valve material prepared by the present method can be used as a valve material required for aortic valve, pulmonary valve, venous valve, mitral valve and tricuspid valve replacement.

A surgical device for assisting in the placement of a prosthetic implant. One or more sheets of polymer are in the form of a conical frustum such that a proximal end is sealed and a distal end is open, with an elongated slit extending from the distal end toward the proximal end. A single opening is formed by the distal opening and the elongated slit with a set of inter-lockable fastener elements disposed along opposing sides and configured to seal the elongated slit such that the distal end remains open to allow for egress of the prosthetic implant for placement into a surgical pocket. A lubricious coating is applied to the interior cavity of the frustum in addition to one or more surface active coatings. Movement of the prosthetic implant across the one or more surface active coatings causes the coatings to provide one or more offered benefits.

There is described inter alia a device having a surface comprising a layered coating wherein the outer coating layer comprises a plurality of cationic hyperbranched polymer molecules characterized by having (i) a core moiety of molecular weight 14-1,000 Da (ii) a total molecular weight of 1,500 to 1,000,000 Da (iii) a ratio of total molecular weight to core moiety molecular weight of at least 80:1 and (iv) functional end groups, whereby one or more of said functional end groups have an anti-coagulant entity covalently attached thereto.

The present disclosure relates to methods of preparing personalized blood vessels, useful for transplantation with improved host compatibility and reduced susceptibility to thrombosis. Also provided are personalized blood vessels produced by the methods and use thereof in surgery.

Provided are an anticoagulation and anticalcification biological material and a preparation method therefor. The preparation method includes the following steps: introducing, on a biological tissue, a polymerizable reactive group, and undergoing free radical copolymerization with a zwitterion. In the present disclosure, by introducing a reactive group capable of free radical polymerization to a biological tissue and undergoing free radical copolymerization with a zwitterionic monomer, collagen in the biological tissue is crosslinked at multiple sites by means of a polymer, thereby achieving sufficient crosslinking within and between collagen fibers, improving the stability of the biological tissue, and prolonging the service life of the biological tissue. Moreover, a zwitterion is introduced to the surface of the biological tissue, to improve the anticoagulation performance, promote the in-situ endothelialization of a biological valve, and prevent the calcium element deposition.

Current approaches in small diameter vascular grafts for coronary artery bypass surgeries fail to address physiological variations along the graft that contribute to thrombus formation and ultimately graft failure. An interlayer drug delivery system can sustain delivery of heparin through the graft with a high degree of temporal and spatial control. A heparin-loaded gelatin methacrylate interlayer sits between a biohybrid composed of decellularized bovine pericardium and poly(propylene fumarate) and UV crosslinking is controlled via 3D printed shadow masks. The masks enable control of the resultant gelMA crosslinking and properties by modulating the incident light intensity on the graft. High doses of heparin have detrimental effects on endothelial cell function. When exposed to heparin in a slower, more sustained manner consistent with the masks, endothelial cells behave similarly to untreated cells. Slower release profiles cause significantly more release of tissue factor pathway inhibitor, an anticoagulant, than a faster release profile.

The present disclosure relates to methods of preparing personalized blood vessels, useful for transplantation with improved host compatibility and reduced susceptibility to thrombosis. Also provided are personalized blood vessels produced by the methods and use thereof in surgery.

A self-expanding wire frame for a pre-configured compressible transcatheter prosthetic cardiovascular valve, a combined inner frame/outer frame support structure for a prosthetic valve, and methods for deploying such a valve for treatment of a patient in need thereof, are disclosed.