A leaflet for a heart valve replacement includes poly(glycerol sebacate) urethane. A heart valve replacement includes a leaflet including poly(glycerol sebacate) urethane. A process forms a leaflet for a heart valve replacement. The process includes casting a first solution including poly(glycerol sebacate) and isocyanate to form a leaflet composition including poly(glycerol sebacate) urethane. The process also includes shaping the leaflet composition to form the leaflet.

An implantable medical device system is configured to generate signals and deliver the signals to a heart of a patient. The implantable medical device system includes electronic circuitry configured to deliver cardiac pacing, couplings for an implantable medical lead receptacle, at least some of the couplings electrically connected with the electronic circuitry, a polymeric enclosure having the electronic circuitry contained therein, the polymeric enclosure formed of polymeric material filled around the electronic circuitry and couplings and forming the implantable medical lead receptacle. The implantable medical device may include a first cavity filled with a first material and a second cavity filled with a second material, and the first material is different than the second material.

The present invention aims to provide a method for producing a porous substrate containing a bioabsorbable polymer and heparin in a simple manner without use of a surfactant, a porous substrate containing a bioabsorbable polymer and heparin, and an artificial blood vessel. The present invention provides a method for producing a porous substrate containing a bioabsorbable polymer and heparin, including: a solution preparing step of preparing a heparin-bioabsorbable polymer solution having heparin uniformly dispersed therein and a bioabsorbable polymer dissolved therein, using the bioabsorbable polymer, the heparin, a solvent 1 that is a poor solvent having a lower solvency for the bioabsorbable polymer, a solvent 2 that is a good solvent having a higher solvency for the bioabsorbable polymer and is incompatible with the solvent 1, and a common solvent 3 compatible with the solvent 1 and the solvent 2; a precipitating step of cooling the heparin-bioabsorbable polymer solution to precipitate a porous body containing the bioabsorbable polymer and the heparin; and a freeze-drying step of freeze-drying the porous body containing the bioabsorbable polymer and the heparin to provide a porous substrate containing the heparin.

A prosthetic heart valve includes a support structure and a valve assembly. The valve assembly includes a cuff and a plurality of leaflets, each of the prosthetic leaflets being composed of a synthetic material. The prosthetic leaflets have a closed condition in which the prosthetic leaflets coapt to restrict blood from flowing in a retrograde direction through the support structure and an open condition in which the prosthetic leaflets allow blood to flow in an antegrade direction through the structure. The synthetic material may be heat set to bias the leaflets to the open or closed condition, or to bias one portion of the leaflet to the open condition and another portion of the leaflet to the closed condition.

Embodiments herein relate to prosthetic heart valves constructed with animal tissue wherein the leaflets are unitary with the inner skirt. In an embodiment, an implantable heart valve assembly is included having a plurality of valve leaflets, an inner skirt, and a metal frame, wherein the plurality of valve leaflets and the inner skirt are formed of a continuous piece of animal tissue. In another embodiment, a method of making an implantable heart valve assembly is included, the method including placing a piece of pericardial tissue over a mold, cross-linking the pericardial tissue in place over the mold, removing the pericardial tissue from the mold, and attaching the pericardial tissue to a frame, wherein the pericardial tissue forms a seamless junction between a plurality of valve leaflets and an inner skirt. Other embodiments are also included herein.

Embodiments herein include a cardiac stent-valve for transcatheter delivery being compressible to a compressed state for delivery, and expandable to an expanded state for implantation. The stent-valve including a stent with an axial inflow end and an axial outflow end, a plurality of leaflets arranged within the stent, and a sealing skirt for reduction or prevention of paravalvular leakage. In the expanded state, the sealing skirt includes a tubular inner wall and at least one pocket which is positioned on the tubular inner wall and comprises an outer wall which extends radially outward from the tubular inner wall. The pocket is configured to be distended radially outward in response to inflow of blood in the expanded state. In the expanded state, the outer wall of the pocket includes one or more pre-shaped bulges which extend radially outward from the outer wall of the pocket. Other embodiments are also included herein.

A method of forming a three-dimensional object, is carried out by (a) providing a carrier and a build plate, the build plate comprising a semipermeable member, the semipermeable member comprising a build surface with the build surface and the carrier defining a build region therebetween, and with the build surface in fluid communication by way of the semipermeable member with a source of polymerization inhibitor; (b) filling the build region with a polymerizable liquid, the polymerizable liquid contacting the build surface, (c) irradiating the build region through the build plate to produce a solid polymerized region in the build region, while forming or maintaining a liquid film release layer comprised of the polymerizable liquid formed between the solid polymerized region and the build surface, wherein the polymerization of which liquid film is inhibited by the polymerization inhibitor; and (d) advancing the carrier with the polymerized region adhered thereto away from the build surface on the build plate to create a subsequent build region between the polymerized region and the build surface while concurrently filling the subsequent build region with polymerizable liquid as in step (b). Apparatus for carrying out the method is also described.

A multilayer bioresorbable stent having sustained drug delivery is disclosed herein. The bioresorbable stent releases a therapeutic substance from the body of the bioresorbable stent starting when the bioresorbable stent is implanted within an anatomical lumen and ending when the entire mass of the bioresorbable stent is no longer present within the anatomical lumen. The bioresorbable stent releases the therapeutic substance gradually during the treatment as the mass of the each layer of the bioresorbable stent erodes. Methods of making the therapeutic layers within the bioresorbable sent are further disclosed. Sustained drug delivery reduces the risk of late and very late stent thrombosis.

A crystallized bioabsorbable polymer scaffold comprises a polymer composition of poly (L-lactide-co-tri-methylene-carbonate) or poly (D-lactide-co-tri-methylene-carbonate) or poly (L-lactide-co-ε-caprolactone) or poly (D-lactide-co-ε-caprolactone) in the form of block copolymers of blocky copolymers, wherein the scaffold is cold-bendable.

A method of forming an implantable biomaterial comprising the steps of providing a polyether-diisocyanate prepolymer, reacting the prepolymer with one or more chain extender molecules typically including benzene 1,4-diol to form a mouldable polymer selected from a polyurethane or polyurethane-urea polymer or a polyurethane-urea block copolymer; placing the mouldable polymer into an implantable biomaterial shaped mould, and shaping and curing the mouldable polymer in the implantable biomaterial shaped mould to form the implantable biomaterial. An implantable biomaterial such as a heart valve leaflet is also disclosed.