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 biomimetic tissue scaffold for repairing an elongated tissue in need of repair can comprise a plurality of coiled flexible polymeric ribbons having a surface on which is formed an array of nanofibers, the ribbons forming a tubular body defining a first open end in which a first end of the elongated tissue is receivable, a second open end in which a second end of the elongated tissue is receivable, and a lumen extending between the first and second open ends.

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.

In a method of integrating an active pharmaceutical ingredient (API) with a thermoplastic polymer, the thermoplastic polymer and API are into a first feed port of a multi-screw extruder or the thermoplastic polymer is fed into the first feed port of a multi-screw extruder, the thermoplastic polymer is conveyed along the heated multi-screw extruder while heating the thermoplastic polymer to a melt temperature of 160° C.-280° C. prior to the thermoplastic polymer being conveyed past a second feed port and the API is fed into the second feeding port in the heated screw extruder to mix with the melted thermoplastic polymer to generate a compounded mixture containing 85-100% of the starting API content. The compounded mixture is extruded from an outlet of the heated screw extruder and cooled via a cooling device such that the compounded mixture contains 85-100% of the starting API content.

According to the invention there is provided inter alia a process for the manufacture of a solid object having a surface comprising a layered coating of cationic and anionic polymer wherein the outer coating layer comprises an anticoagulant entity, comprising the steps of: i) treating a surface of the solid object with a cationic polymer; ii) treating the surface with an anionic polymer; iii) optionally repeating steps i) and ii) one or more times; iv) treating the surface with a cationic polymer; and v) treating the outermost layer of cationic polymer with an anticoagulant entity, thereby to covalently attach the anticoagulant entity to the outermost layer of cationic polymer; wherein, the anionic polymer is characterized by having (a) a total molecular weight of 650 kDa-10,000 kDa; and (b) a solution charge density of >4 μeq/g; and wherein, step ii) is carried out at a salt concentration of 0.25 M-5.0 M.

A system for preventing thrombosis in an implantable medical device includes an implantable medical device sized for implantation at least partially within a patient's body. The device includes an at least partially electrically conductive portion that is disposed within a patient's body upon implantation, an electrode coupled to the electrically conductive portion of the device; and a power source coupled to the electrode. The power source provides a negative electric charge to the at least partially electrically conductive portion for an indefinite period of time. The device may be configured to resist thrombosis, infection, and/or undesired tissue growth via the charged conductive portion once implanted. Exemplary embodiments of the implantable medical device include a hemodialysis vasculature graft, a dialysis catheter, a coronary artery, and a heart valve.

A system for preventing thrombosis in an implantable medical device includes an implantable medical device sized for implantation at least partially within a patient's body. The device includes an at least partially electrically conductive portion that is disposed within a patient's body upon implantation, an electrode coupled to the electrically conductive portion of the device; and a power source coupled to the electrode. The power source provides a negative electric charge to the at least partially electrically conductive portion for an indefinite period of time. The device may be configured to resist thrombosis, infection, and/or undesired tissue growth via the charged conductive portion once implanted. Exemplary embodiments of the implantable medical device include a hemodialysis vasculature graft, a dialysis catheter, a coronary artery, and a heart valve.

The invention is an improved biocompatible surface for a variety of medical purposes. The biocompatible surface employs a unique tight microstructure that demonstrates enhanced cellular response in the body, particularly when placed in contact with blood. As a blood contact surface, the present invention can be beneficially employed in a wide variety of implantable devices and in many other devices and equipment that come in contact with blood.

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.

Intraocular pressure sensors, systems, and methods of use. Implantable intraocular pressure sensing devices that are hermetically sealed and adapted to wirelessly communicate with an external device. The implantable devices can include a hermetically sealed housing, the hermetically sealed housing including therein: an antenna in electrical communication with a rechargeable power source, the rechargeable power source in electrical communication with an ASIC, and the ASIC in electrical communication with a pressure sensor.