Abstract: The present invention provides a prosthetic heart valve device that has a frame, and a leaflet assembly having a plurality of leaflets that are secured to the frame. The frame is defined by an annular body and has three spaced-apart commissure regions, each commissure region having a commissure post extending from a proximal outflow end of the frame. A first clipping arm and a second clipping arm extend from opposite sides of each commissure post, each clipping arm extending from each commissure post at an obtuse angle with respect to each commissure post. Each clipping arm has a free end with a tip provided at the free end. The body has a first diameter at a location where the tips of the clipping arms are located, and the tips of the clipping arms extend away from define a second diameter, with the second diameter being greater than or equal to the first diameter.

Abstract: A gradually-expandable stent includes a base ring completely encircling a central valve-accepting area. A plurality of uprights is provided. Each upright includes two longitudinally extending upright struts. Each upright strut has a strut base directly connected to the base ring and a strut tip directly attached to the other strut tip of the upright strut at a rounded upright apex. The upright apex is longitudinally spaced from the base ring. At least one expansion feature is associated with the base ring and gradually expands to enlarge the central valve-accepting area toward a maximum valve-accepting area responsive to growth of the patient over an extended dwell time.

Abstract: A medical device and method for facilitating a surgery through a body opening is disclosed. The medical device includes a flexible member configured to be placed within the body opening so as to cover a portion of the body opening. The flexible member includes a distal end portion with a closed end, a proximal end portion with an open end and an elongate portion joining the proximal end portion and the distal end portion. The proximal end portion is configured to extend out of the patient's body opening to cover an area around and outside the patient's body opening.

Abstract: An orthopedic implant comprising a metallic substrate coated with a diamond-like carbon (DLC) layer, and a layer of a polymeric material placed over the DLC layer that is less stiff than the substrate, and methods of manufacturing the same.

Abstract: This disclosure relates to substrates containing at least one polyphosphazene with a forming surface as matrices for producing biological materials that can be implanted in a mammal. The disclosure also relates to a method for producing such substrates and substrates containing polyphosphazene with a micro-structured surface.

Abstract: A thin, biocompatible, high-strength, composite material is disclosed that is suitable for use in various implanted configurations. In one aspect, the composite material maintains flexibility in high-cycle flexural applications, making it particularly applicable to high-flex implants such as heart pacing lead or heart valve leaflet. The composite material includes a porous expanded fluoropolymer membrane and an elastomer, wherein the elastomer fills substantially all of the pores of the porous expanded fluoropolymer, and the composite material comprising less than about 80% fluoropolymer by weight.

Abstract: A thin, biocompatible, high-strength, composite material is disclosed that is suitable for use in various implanted configurations. The composite material maintains flexibility in high-cycle flexural applications, making it particularly applicable to high-flex implants such as heart pacing lead or heart valve leaflet. The composite material includes at least one porous expanded fluoropolymer layer and an elastomer substantially filling substantially all of the pores of the porous expanded fluoropolymer.

Abstract: Medical devices for positioning a valve in a subject's body, such as a prosthetic heart valve in a subject's heart, are disclosed. The prosthetic heart valve may include a valve assembly, a frame, and a control arm. The prosthetic heart valve may include a commissural post or multiple commissural posts. The prosthetic heart valve may include a positional marker on a control arm. The prosthetic heart valve may include multiple positional markers on one or more control arms. The positional markers can be shapes, characters, or other symbols. The positional markers may themselves be asymmetric. The positional markers may be placed in an asymmetric location on a control arm. The control arm may be asymmetrically shaped.

Abstract: The present invention relates to a biomedical implant for use in a fluid shear stress environment of a subject. The biomedical implant of the present invention includes a patterned surface having a plurality of cellular niches. The cellular niches of the patterned surface are effective to maintain at least one localized layer of living cells within the plurality of cellular niches by decreasing fluid shear stress within the cellular niches as compared to fluid shear stress measured outside of the cellular niches, with the fluid shear stress measured outside of the cellular niches having a peak fluid shear stress of at least about 50 dynes per square centimeter (dynes/cm2). The present invention also relates to methods of making and using the biomedical implant. The present invention further relates to a biomedical implant system.

Abstract: A structure for sealing a gap between a medical device and adjacent body tissue includes a ring-shaped body formed at least in part of a material that expands from a compressed condition to an expanded condition when heated to a transition temperature and that is adapted to conform to the body tissue in the expanded condition.

Abstract: Embodiments provided herein are related to prosthetic heart valve leaflets comprising one or more imageable elements that allow for visualization of the movement of the leaflets using imaging techniques, such as, but not limited to fluoroscopy, x-ray, ultrasound, and MRI. When visualized using visualization techniques, the movement of the imageable element is directly related to the movement of the leaflet to which it is coupled, and therefore the movement of the leaflet may be determined.

Abstract: The invention concerns a minimally invasive valve repair system (2), in particular a mitral valve repair system (2) or a tricuspid valve repair system. The system comprises a valve component (3), in particular a mitral valve component (3) or a tricuspid valve component, holding or adapted to hold a valve (4), in particular a mitral valve (4) or a tricuspid valve, respectively. The system (2) comprises a linker-component (6) by means of witch the valve component (3) is linked or linkable to an anchor support (5), in particular an in particular an aortic valve or aortic anchor support (5) or a pulmonic valve or pulmonary artery anchor support, respectively.

Abstract: A prosthetic heart valve assembly comprises a plurality of leaflets configured to replace the function of a native heart valve. Each leaflet comprises laminar pericardium tissue. Each leaflet has a coaptation edge formed by laser cutting. The tissue layers of each leaflet are fused together along an entire length of the coaptation edge, and tissue adjacent each coaptation edge does not have significant thermal energy damage.

Abstract: This disclosure describes decellularized, biologically-engineered tubular grafts and methods of making and using such decellularized, biologically-engineered tubular grafts.

Abstract: Disclosed are an apparatus and a method for manufacturing an implant having a screw thread on an inner peripheral surface or an outer peripheral surface thereof by die-casting or pressing an amorphous alloy. The apparatus for manufacturing an implant using an amorphous alloy includes: a heating unit for heating a pre-form formed of an amorphous alloy into a semi-solid state; a forming unit for forming a screw thread in the heated pre-form by using a pressing mold; and a cooling unit for cooling the pre-form having the screw thread.

Abstract: Disclosed is a medical device treated with a phenolic compound and a process for treating a device with the phenolic compound. For example, a collagen or elastin-based scaffold can be treated with pentagalloyl glucose (PGG). The treated scaffold can become resistant to glycoxidative stress associated with advanced glycation end products (AGEs) that are present in a hyperglycemic environments associated with diabetes mellitus. The treated scaffold can exhibit a reduced increase in stiffness as compared to an untreated scaffold. The treated scaffold can also exhibit reduced inflammation without negatively affecting the ability of the scaffold to remodel in vivo.

Abstract: An intra-annular mounting frame for an aortic valve having native aortic cusps is provided which includes a frame body with native leaflet reorienting curvatures and interconnecting points; the curvatures shaped to be received inside the valve below the native aortic cusps and to reorient the native aortic cusps within the aortic valve, where each of the curvatures extends concavely upward from a reference latitudinal plane tangential to each curvature's base.

Abstract: The invention is directed to an ion plasma deposition (IPD) method adapted to coat polymer surfaces with highly adherent antimicrobial films. A controlled ion plasma deposition (IPD) process is used to coat a metal or polymer with a selected metal/metal oxide. Exposing the coated surface to ultraviolet light significantly improves the antimicrobial properties of the deposited coatings.

Abstract: Expandable sealing means for endoluminal devices have been developed for controlled activation. The devices have the benefits of a low profile mechanism (for both self-expanding and balloon-expanding prostheses), contained, not open, release of the material, active conformation to the “leak sites” such that leakage areas are filled without disrupting the physical and functional integrity of the prosthesis, and on-demand, controlled activation, that may not be pressure activated.

Abstract: The invention relates to scaffolds for artificial heart valves and vascular structures comprising a biocompatible block copolymer. A method and means for producing said scaffold are also provided.

Abstract: Methods and devices for treating defective heart valves are disclosed herein. In one exemplary embodiment, a transcatheter heart valve includes an expandable shape memory stent and a valve member supported by the stent. A plurality of micro-anchors can be disposed along an outer surface of the stent for engaging native tissue. The transcatheter heart valve can be configured to be advanced into a dilated valve annulus via a balloon catheter. The balloon can be inflated to expand the transcatheter heart valve from a collapsed diameter to an over-expanded diameter such that the micro-anchors engage tissue along the surrounding valve annulus. After engaging the tissue, the balloon can be deflated and the shape memory stent can retract or recoil toward its predetermined recoil diameter. As the stent recoils, the surrounding tissue is pulled inward by the stent such that the diameter of the valve annulus is reduced.

Abstract: A modified polyurethane including a lipid substituent pendant from at least one urethane nitrogen and/or at least one carbon atom of the modified polyurethane, methods of preparing modified polyurethanes and the use thereof as an implantable biomaterial.

Abstract: A prosthetic valve device, a method for making a valve device, and a method for implanting a valve device into a recipient are provided. The valve device includes at least one flexible member formed at least partially from a woven layer. The woven layer includes a first material and a second material being at least partially woven together. The at least one flexible member is movable between a first position that permits fluid flow in a first direction and a second position that substantially prevents fluid flow in a second direction. The valve has a first, unexpanded configuration and a second, expanded configuration.

Abstract: A valve for a heart valve prosthesis comprising a valve membrane composed of at least one spiral strip which, in the closed state of the valve membrane, assumes the form of an Archimedean spiral, wherein the outer edge regions of the spiral strip overlap an inner edge region of the spiral strip of a previous winding of the spiral.

Abstract: In various embodiments, a coated device comprises: a substrate; a film coating at least part of the substrate, which film comprises a multilayer unit comprising a first layer and a second layer associated with one another via a hydrogen bond, wherein the first layer comprises a first natural polymeric material and a hydrogen bond donor and wherein the second layer comprises a second natural polymeric material and a hydrogen bond acceptor; and an agent for delivery associated with the coated device. In various embodiments, a coated device comprises: a substrate; a film coating at least part of the substrate, which film comprises a multilayer unit comprising a tetralayer with alternating layers of opposite charge; and an agent for delivery associated with the coated device.

Abstract: A device for regulating blood pressure between a patient's left atrium and right atrium comprises an hourglass-shaped stent comprising a neck region and first and second flared end regions, the neck region disposed between the first and second end regions and configured to engage the fossa ovalis of the patient's atrial septum; and a one-way tissue valve coupled to the first flared end region and configured to shunt blood from the left atrium to the right atrium when blood pressure in the left atrium exceeds blood pressure in the right atrium. The inventive devices may reduce left atrial pressure and left ventricular end diastolic pressure, and may increase cardiac output, increase ejection fraction, relieve pulmonary congestion, and lower pulmonary artery pressure, among other benefits. The inventive devices may be used, for example, to treat subjects having heart failure, pulmonary congestion, or myocardial infarction, among other pathologies.

Abstract: Prosthetic valve devices for implantation in body vessels are provided. The prosthetic valve device includes at least one flexible member that permits fluid flow in a first direction and substantially prevents fluid flow in a second. The valve device also includes an inflatable chamber at least partially attached to the flexible member. The inflatable chamber is adapted to receive inflating media and is adapted to contact the body vessel. A delivery system is also provided that includes a valve device and a delivery apparatus. The delivery apparatus includes a member adapted for filling the chamber of the valve device with inflating media. A related method of making the valve device is also provided.

Abstract: A system and method for treating and repairing complex anatomy characterized by a plurality of vessel portions oriented at various angles relative to each other. The system including a graft device that is capable of being assembled in situ and has associated therewith a method that avoids the cessation of blood flow to vital organs. A delivery catheter system and various graft supporting, mating and anchoring structures are additionally included.

Abstract: The invention relates to medical technology and could be used in manufacturing artificial cardiac valves having one or more cusps made of a polymer composite. The method for manufacturing a cusp of an artificial cardiac valve, includes the steps of: manufacturing a casting mold, and molding a cusp from a polymer composite comprising 78 to 92% by weight of polyamide and 8 to 22% by weight of radiographic contrast medium dispersed therein. The polymer composite can comprise additionally fine acetylene black in amount of 1 to 2% by weight. The preferred radiographic contrast medium is barium sulphate. In one embodiment of the method, the casting mold is manufactured for the molding size 1 to 5% less than necessary, and the cusp is placed after molding into an anticoagulant solution and matured therein until expanding by 1 to 5%.

Abstract: The invention is directed to two minimally invasive therapeutic procedures, particularly for patients with congestive heart failure, and devices and systems for such procedures. One procedure involves providing a valved passageway through the patient's left ventricular wall at the apex of the patient's heart and advancing instruments through the valved passageway to connect the valve leaflets of the patient's heart valve, e.g. the mitral valve, in a “Bow-Tie” configuration to prevent or minimize regurgitation through the valve. The second procedure involves advancing a pacing lead and a pacing lead implanting device through a trocar in the patient's chest and implanting the pacing lead on an exposed epicardial region of the patient's heart wall. The pacing lead has a penetrating electrode which is secured within the heart wall. One or both procedures may be performed on a patient with CHF.

Abstract: Disclosed are cellulose-based pliable, porous and non-porous prosthesis structures that can be formed to various geometries such as thin films, membranes, hollow tubes, heart valves, including an aortic heart valve. Also disclosed are methods for preparing a cellulose-based porous prosthesis structure.

Abstract: The invention relates to an implantable valve prosthesis, optionally comprising a support structure and at least one valve leaflet. The valve prosthesis comprises a material structure of unidirectional reinforcing elements of drawn ultra high molecular weight polyolefin, extending in at least two directions, wherein the modulus of elasticity of the polyolefin reinforcing elements is at least 60 GPa. The invention furthermore relates to a method for manufacturing such an implantable valve. The valve is easily manufactured and has an improved durability.

Abstract: A method for direct therapeutic treatment of myocardial tissue in a localized region of a heart having a pathological condition. The method includes identifying a target region of the myocardium and applying material directly and substantially only to at least a portion of the myocardial tissue of the target region. The material applied results in a physically modification the mechanical properties, including stiffness, of said tissue. Various devices and modes of practicing the method are disclosed for stiffening, restraining and constraining myocardial tissue for the treatment of conditions including myocardial infarction or mitral valve regurgitation.

Abstract: Methods for treating xenogenic tissue for implantation into a human body including in-situ polymerization of a hydrogel polymer in tissue, and tissue treated according to those methods, where the polymerization takes place in tissue that has not been fixed with glutaraldehyde. The polymerization may only fill the tissue, bind the polymer to the tissue, or cross-link the tissue through the polymer, depending on the embodiment. One method includes free radical polymerization of a first vinylic compound, and can include cross-linking through use of a second compound having at least two vinyl groups. Another method utilizes nucleophilic addition polymerization of two compounds, one of which can include PEG and can further include hydrolytically degradable regions. In one embodiment, applicants believe the in-situ polymerization inhibits calcification, and that the polymerization of tissue un-fixed by glutaraldehyde allows for improved penetration of the polymer.

Abstract: Disclosed is a biocompatible block copolymer containing the polycondensation product of a diol and an additional component selected from the group of the same diol, an ?,?-dihydroxy-polyester or an ?,?-dihydroxy-polyether. Also disclosed are a medical implant containing the block copolymer, the use of said block copolymer for the production of a medical implant, a diol and a method for the production thereof. The diol may be obtained by transesterification of ?,?-dihydroxy-[(oligo(3-(R)-hydroxybutyrate)-ethylene-oligo-(3-(R)-hydroxybutyrate)] with diglycolide. Transesterification is carried out, preferably, in the presence of a catalyst.

Abstract: This disclosure encompasses a bioprosthetic heart valve having a polyphosphazene polymer such as poly[bis(trifluoroethoxy)phosphazene], which exhibits improved antithrombogenic, biocompatibility, and hemocompatibility properties. A method of manufacturing a bioprosthetic heart valve having a polyphosphazene polymer is also described.

Abstract: This invention provides a new class of medical devices and implants comprising amorphous metal alloys. The medical devices and implants may be temporary or permanent and may comprise other materials as well, such as polymers, ceramics, and conventional crystalline or polycrystalline metal alloys. Specifically, this invention provides an artificial heart component, such as an artificial heart valve or a pacemaker, wherein the artificial heart component includes an amorphous metal alloy component. The artificial heart valve may be a ball valve comprising an amorphous metal alloy cage. Alternatively, the artificial heart valve can include leaves made of amorphous metal alloy. The amorphous metal alloy component may also be a sheath or a strut. The pacemaker containing the amorphous metal alloy may house an energy source which is shielded from the body by the amorphous metal alloy.

Abstract: A biomaterial useful for bioprostheses such as bioprosthetic heart valves is provided in which the fixed tissue has improved elastic properties. The high elastin-containing biomaterial is further characterized by having anisotropic properties wherein the biological material has a greater stiffness in one direction and a greater elasticity in a cross direction. For instance, the biological material has an elastin content of about 30% by weight. In one embodiment, the biological material is vena cava tissue.

Abstract: Provided herein are implantable medical devices comprising a biodegradable multiblock copolymer comprising at least three blocks; wherein the at least three blocks includes at least one inner block and two end blocks; further wherein each of the at least one inner block comprises monomers selected from the group consisting of e-caprolactone, r-butylactone, trimethylene carbonate, caprolactone derivatives, P-Dioxanone, and combinations thereof; and further wherein each of the end blocks comprises monomers selected from the group consisting of l-lactide, D-lactide, glycolide, L,D-lactide, and combinations thereof.

Abstract: An objective of the present invention is to analyze the function of anti-angiogenic factors in cardiac valves or such to elucidate the developmental mechanism of angiogenesis-induced diseases. A more specific objective is to provide therapeutic agents for angiogenesis-induced diseases such as valvular heart disease, and methods of efficiently screening for the therapeutic agents. The present inventors discovered that chondromodulin-I was markedly expressed in cardiac valves, and plays an important role in maintaining normal functions of the valves by preventing angiogenesis, thickening, and calcification which lead to valvular heart diseases. Chondromodulin-I proteins and substances that activate the expression or function of the proteins are expected to have therapeutic effects against angiogenesis-induced diseases.

Abstract: Methods of reducing retrograde fluid flow through a valve within a body vessel are provided. The methods can include the steps of identifying a valve exhibiting an undesirable amount of retrograde fluid flow within a body vessel, such as a venous valve or a heart valve, and providing a means for reducing the retrograde fluid flow. A medical device providing a desired amount of retrograde fluid flow can be modified after permitting the medical device to remain in a body cavity for a remodeling-effective time period. The implanted medical device can be modified by subsequently reducing the amount of retrograde fluid flow permitted across the implanted prosthetic valve within the body vessel.

Abstract: A biocompatible biological component is provided comprising a membrane-mimetic surface film covering a substrate. Suitable substrates include hydrated substrates, e.g. hydrogels which may contain drugs for delivery to a patient through the membrane-mimetic film, or may be made up of cells, such as islet cells, for transplantation. The surface may present exposed bioactive molecules or moieties for binding to target molecules in vivo, for modulating host response when implanted into a patient (e.g. the surface may be antithrombogenic or antiinflammatory) and the surface may have pores of selected sizes to facilitate transport of substances therethrough. An optional hydrophilic cushion or spacer between the substrate and the membrane-mimetic surface allows transmembrane proteins to extend from the surface through the hydrophilic cushion, mimicking the structure of naturally-occurring cells.

Abstract: Medical devices for implantation in a body vessel are provided. Each medical device comprises a main body, a valve, and a vessel engaging member. The vessel engaging member is disposed on an outer surface of the main body. Kits including a plurality of vessel engaging members for use with one or more valve members are also provided. The vessel engaging members have varying radial dimensions, allowing assembly of medical devices having varying radial dimensions. Methods of treating a patient using medical devices according to the invention are also provided.

Abstract: The invention provides an article of manufacture comprising a substantially non-immunogenic heart valve xenograft for implantation into humans. The invention further provides methods for preparing a heart valve xenograft by removing at least a portion of a soft tissue from a non-human animal to provide a xenograft; washing the xenograft in saline and alcohol; subjecting the xenograft to cellular disruption treatment; treating the xenograft with crosslinking agents, and digesting the xenograft with a proteoglycan-depleting factor and/or glycosidase. The invention also provides an article of manufacture produced by the above-identified method of the invention. The invention further provides a heart valve xenograft for implantation into a human including a portion of a heart valve from a non-human animal, wherein the portion has extracellular components and substantially only dead cells. The extracellular components have reduced proteoglycan molecules.

Abstract: Medical devices can be formed from improved composite materials that include a composition that has at least about 50 percent by volume pyrolytic carbon and a second composition having at least about 50 percent by volume metal/metalloid carbide. The composite material can optionally include a substrate. Some embodiments of the composite material have the pyrolytic carbon material at exposed surfaces.

Abstract: Disclosed are cellulose-based pliable, porous and non-porous prosthesis structures that can be formed to various geometries such as thin films, membranes, hollow tubes, heart valves, including an aortic heart valve. Also disclosed are methods for preparing a cellulose-based porous prosthesis structure.

Abstract: In accordance with one embodiment of the present disclosure, a prosthetic valve is provided. The prosthetic valve includes an annulus, a pair of leaflets, and a pair of support elements. The annulus has a generally saddle-shape formed by a movable pair of first portions separated from each other by a movable pair of second portions. The pair of leaflets extend from the annulus and are separated from each other by the pair of support elements. The first portions of the annulus and the second portions of the annulus are configured to move back and forth from being generally concave to being generally convex such that any movement of the first portions of the annulus occurs at generally the same time as any movement of the second portions of the annulus.

Abstract: The disclosure relates to implantable prosthetic valves comprising support frames. The support frames may include a plurality of symmetrically arrayed interconnected U-shaped member structures. Preferred support frames are tubular structures enclosing a longitudinal axis and including a plurality of U-shaped member structures facing a distal or a proximal end of the support frame. Each U-shaped member structure may be connected to a single longitudinally adjacent U-shaped member facing in an opposite longitudinal direction, as well as two laterally adjacent U-shaped members.

Abstract: It has been discovered that improved yields of engineered tissue following implantation, and engineered tissue having enhanced mechanical strength and flexibility or pliability, can be obtained by implantation, preferably subcutaneously, of a fibrous polymeric matrix for a period of time sufficient to obtain ingrowth of fibrous tissue and/or blood vessels, which is the removed for subsequent implantation at the site where the implant is desired. The matrix is optionally seeded prior to the first implantation, after ingrowth of the fibrous tissue, or at the time of reimplantation. The time required for fibrous ingrowth typically ranges from days to weeks. The method is particularly useful in making valves and tubular structures, especially heart valves and blood vessels.

Abstract: It has been discovered that improved yields of engineered tissue following implantation, and engineered tissue having enhanced mechanical strength and flexibility or pliability, can be obtained by implantation, preferably subcutaneously, of a fibrous polymeric matrix for a period of time sufficient to obtain ingrowth of fibrous tissue and/or blood vessels, which is the removed for subsequent implantation at the site where the implant is desired. The matrix is optionally seeded prior to the first implantation, after ingrowth of the fibrous tissue, or at the time of reimplantation. The time required for fibrous ingrowth typically ranges from days to weeks. The method is particularly useful in making valves and tubular structures, especially heart valves and blood vessels.