Abstract: A valve prosthesis system includes a prosthetic aortic valve and a non-implantable unit. The prosthetic aortic valve includes a plurality of prosthetic leaflets; a frame; a cathode and an anode, which are mechanically coupled to the frame; and a prosthetic-valve coil, which is in non-wireless electrical communication with the cathode and the anode. The prosthetic aortic valve does not include any active electronic components. The non-implantable unit includes an energy-transmission coil; sensing skin ECG electrodes; and non-implantable control circuitry, which drives the cathode and the anode to apply a pacing signal to a heart, detect at least one cardiac parameter using the sensing skin ECG electrodes, and, at least partially responsively to the detected cardiac parameter, to set parameters of the pacing signal, by wirelessly transferring energy from the energy-transmission coil to the prosthetic-valve coil by inductive coupling. Other embodiments are also described.

Abstract: A heart valve assembly has a frame comprising an anchoring section, a generally cylindrical leaflet support section, and a neck section that transitions between the anchoring section and the valve support section. The anchoring section has a ball-shaped configuration defined by a plurality of wires that extend from the leaflet support section, with each wire extending radially outwardly to a vertex area where the diameter of the anchoring section is at its greatest, and then extending radially inwardly to a hub. A plurality of leaflets are stitched to the leaflet support section. The heart valve assembly is delivered to the location of a native pulmonary trunk, the vertex area of the anchoring section is deployed into the native pulmonary arteries such that the vertex area is retained in the pulmonary arteries, and then the leaflet support section is deployed in the pulmonary trunk.

Abstract: Embodiments of a prosthetic heart valve comprise an annular main body, an atrial cap extending radially outwardly from the atrial end of the main body, and a plurality of ventricular anchors extending outwardly from the ventricular end of the main body. Each ventricular anchor can have a proximal end portion connected to the ventricular end, an intermediate portion extending away from the atrial end and then back toward the atrial so as to define a first bend, and a free distal end portion that extends from the intermediate portion. The distal end portion can comprise a first section, a second section, and a second bend between the first and second sections, the first section extending from the intermediate portion in a direction toward the atrial end and radially away from the main body.

Abstract: A method for evaluating the placement of a prosthetic heart valve in a structure of interest. The method comprises acquiring one or more depictions of an anatomical region of interest that includes the structure of interest, wherein each depiction shows the structure of interest and/or the blood pool volume of the left ventricular outflow tract (LVOT) of the patient's heart. The method further comprises designating one or more positions in at least one of the one or more depictions wherein each position corresponds to a respective position in the structure of interest at which the prosthetic valve may be placed. The method still further comprises predicting, for each of the one or more designated positions, an amount of blood flow obstruction through the LVOT of the patient's heart that would occur if the prosthetic valve was to be placed at a corresponding position in the structure of interest.

Abstract: A system and method for conditioning surfaces of a body in vivo includes providing an electrical energy source, coupling the electric energy source to the surface, and delivering electropositive current from the electrical energy source to the surface so as to generate a sub-threshold current density on the surface. In preferred embodiments, the sub-threshold electropositive current density is between about 0.001 and about 1.0 mA/cm2.

Abstract: A heart valve prosthesis has an annular body (2) and with several flap elements (4) which are movably connected to the annular body (2) via joints (10). The joints (10) engage on the flap elements (4) at their ventricular surface (18).

Abstract: A delivery catheter and a method for deploying a cardiovascular prosthetic implant using a minimally invasive procedure are disclosed. The delivery catheter comprises an elongate, flexible catheter body having a proximal end and a distal end, wherein the distal end has an outer diameter of 18 French or less, a cardiovascular prosthetic implant at the distal end of the catheter body, wherein the cardiovascular prosthetic implant comprises an inflatable cuff and a tissue valve coupled to the inflatable cuff, and at least one link between the catheter body and the cardiovascular prosthetic implant.

Abstract: A prosthetic heart valve for functionally replacing a previously implanted prosthetic heart valve is disclosed. The prosthetic heart valve includes a collapsible support structure with leaflets and anchors mounted to the support structure. The support structure also includes an inflow end and an outflow end. The anchors include a radially outwardly extending first anchor proximate to the inflow end and a radially outwardly extending second anchor proximate to the outflow end. The first anchor includes a first configuration and the second anchor includes a second configuration where the first configuration is different than the second configuration. The previously implanted prosthetic heart valve serves as a platform for securement of the prosthetic heart valve to the patient's native tissue.

Abstract: Methods, devices, and systems induce neuromodulation by focusing a source of stimulation through a skull/brain interface in the form of an aperture formed in the skull, a naturally occurring fenestration in the skull, or a transcranial channel. Methods, devices, and systems identify where to locate skull/brain interfaces, accessories that can be used with the interfaces, and features for controlling stimulation delivered through the interfaces. Multiple indications for the skull/brain interfaces include diagnosis and treatment of neurological disorders and conditions such as epilepsy, movement disorders, depression, Alzheimer's disease, autism, coma, and pain.

Abstract: A prosthetic mitral heart valve having four separate flexible leaflets. The heart valve includes a support frame that may be non-circular, for example elliptical or “D-shaped”. The support frame may have an undulating outflow edge defined by four inflow cusps and four outflow commissures to which each of the flexible leaflets attaches. The support frame may comprise an undulating wireform and a surrounding stent defining a structure having four cantilevered posts projecting in the outflow direction to support the four leaflets. The heart valve is designed to be secured in the annulus and function as a standalone unit without papillary muscle connections to the leaflets. The four leaflets may be arranged in two opposed pairs, one pair being smaller than the other pair. The larger pair of leaflets may be identical, or differently sized. Existing sizes of heart valve leaflets may be utilized with the smaller leaflets being at least two leaflet sizes smaller than the larger leaflets in odd millimeter increments.

Abstract: A valved stent including a stent structure having a generally tubular body portion with an interior area, a first end, a second end, and a longitudinal axis; a valve structure including a plurality of leaflets and positioned within the interior area of the stent structure; and an invertible structure extending from one of the first and second ends of the stent structure. The invertible structure can be rotatable relative to the end of the stent structure from which it extends.

Abstract: The invention relates to a housing part containing a lubricant reservoir and at least one respective inlet and outlet opening for filling and draining a lubricating fluid into and from the lubricant reservoir. The inlet and outlet openings are sealed by releasable closure devices each comprising a sensor means for determining the operation parameters in a lubricant contained in the lubricant reservoir and for generating and/or storing sensor signals, as well as a transceiver for the transmission of the sensor signals to an external processing unit.

Abstract: An epicardial clip for reshaping the annulus of the mitral valve of a heart. The epicardial clip includes a curved member having an anterior segment configured to be positioned in the transverse sinus of the heart, a posterior segment configured to be positioned on the posterior side of the heart, such as on or inferior to the atrioventricular groove, and a lateral segment extending between the anterior segment and the posterior segment. The lateral segment includes a curve such that the first end of the member is positioned at or above the plane of the mitral valve and the second end of the member is positioned at or below the plane of the mitral valve.

Abstract: Apparatus for regulating blood flow of a subject is provided, the apparatus comprising a prosthetic valve that comprises a tubular element, shaped to define a lumen therethrough; and a valve member, configured to be coupled to the tubular element and to be disposed within the lumen. The prosthetic valve has (1) a compressed configuration in which the lumen has a compressed width, the valve member is generally cylindrical, and the prosthetic valve is configured to be percutaneously delivered into the subject, and (2) an expanded configuration in which the lumen has an expanded width that is greater than the compressed width, and the valve member is generally disc-shaped, is coupled to the tubular element, and is disposed within the lumen. Other embodiments are also described.

Abstract: A transluminal cardiac valve includes an expandable generally tubular cage including when expanded a generally uniform central region, first and second ends each diametrically constricted relative to the central region, a blood impervious region extending from the first end of the cage to within the generally uniform central region, and an inflatable plunger freely disposed and captured within the cage when inflated.

Abstract: A replacement heart valve can have an expandable frame configured to engage a native valve annulus. A valve body can be mounted onto the expandable frame to provide functionality similar to a natural valve. The valve body has an upstream end and a downstream end, and a diameter at the downstream end is greater than a diameter at the upstream end.

Abstract: A prosthetic blood valve comprises a base body having a hollow, opposing props extending from the body to partition opposing inclined ridges of the body to allow the inclined ridges and each top of the props to define the hollow and to form an upper surface of the body, and a singular leaflet attached to and along the inclined ridges and the prop tops to cover the hollow. The singular leaflet has a substantially central opening between the props and formed of a flexible material so a forward or outward blood flow passes through the opening and a reverse flow or backflow of blood leads to opposing leaflet portions around the opening being abuttingly pulled to each other to thereby prevent the blood backflow.

Abstract: A valve prosthesis for percutaneous placement within a vein is disclosed that includes a valve scaffold and a backflow barrier. The valve scaffold is of a shape memory or resilient material and the backflow barrier is a flap of flexible material attached to the valve scaffold. The valve prosthesis is operable to alternate between open and closed configurations in response to changes in retrograde blood flow pressure. In the open configuration, the valve scaffold has a frustoconical coil shape of consecutive windings with open spaces therebetween and the backflow barrier allows antegrade blood flow through the open spaces. In the closed configuration, the consecutive windings of the valve scaffold are collapsed such that the valve scaffold has a substantially flat profile and the backflow barrier covers the opens spaces of the flattened valve scaffold to prevent retrograde blood flow from leaking there through.

Abstract: Anatomical orifice sizers that are optimally proportional to an associated prosthetic device such as a heart valve, and methods of use are provided. The sizers are desirably slightly larger than the rigid mounting diameter of the corresponding heart valve. The heart valve sizer may be cylindrical and have a diameter about 0.3 mm larger than the valve mounting diameter. The sizer preferably has a length of between about 19 mm to 22 mm, and the edges are desirably rounded to a minimum 1 mm radius. The method includes providing a set of cylindrical sizers having varying diameters; sequentially inserting at least two of the sizers through the annulus; measuring the push force needed to pass each sizer through the annulus; selecting a valve corresponding to the sizer for which the measured push force is between about 150 and 300 grams.

Abstract: An apparatus for treating regurgitation of blood through a diseased heart valve having at least two leaflets includes an occluding member configured to be positioned within the diseased heart valve so that at least a portion of the occluding member is positioned adjacent to one of the at least two leaflets. The at least one portion of the occluding member contacts at least one surface of the at least one leaflet. The occluding member is dimensioned so that the at least one leaflet abuts the at least one surface of the occluding member. The apparatus further includes a suspending wire operatively attached to the occluding member and configured to facilitate positioning of the occluding member within the heart valve. The suspending wire includes an anchoring portion having a coiled shape. The anchoring portion is configured to secure the suspending wire to at least one of a blood vessel and a heart wall surrounding a heart chamber.

Abstract: The invention relates to a prosthetic valve for regulating fluid flow through a body lumen. The valve includes a frame and a valve member comprising at least one semi-rigid leaflet and at least one flexible leaflet.

Abstract: A heart valve prosthesis that can be quickly and easily implanted during a surgical procedure is provided. The prosthetic valve has a base stent that is deployed at a treatment site, and a valve component configured to quickly connect to the base stent. The base stent may take the form of a self- or balloon-expandable stent that expands outward against the native valve with or without leaflet excision. The valve component has a non-expandable prosthetic valve and a self- or balloon-expandable coupling stent for attachment to the base stent, thereby fixing the position of the valve component relative to the base stent. The prosthetic valve may be a commercially available to valve with a sewing ring and the coupling stent attaches to the sewing ring. The system is particularly suited for rapid deployment of heart valves in a conventional open-heart surgical environment. A catheter-based system and method for deployment is provided.

Abstract: A cardiac valve with a first anchor frame and a cover on the first anchor frame for unidirectional flow of a liquid through the valve.

Abstract: A biocompatible valve (200) includes a valve mechanism (250, 230a, 230b), which is mounted and is longitudinally displaceable within a valve mount (210) affixed to a recipient patient. A valve annulus (250) defines an orifice (240) in which a closing mechanism (230a, 230b) is received. Upon a transition from an open position to a closed position of the closing mechanism (230a, 230b), hydraulic shock is introduced into the fluid passing through the valve. The present invention provides a dampening mechanism (280) to mitigate the shock and to dissipate its energy. Various embodiments allow for high order frequency response through relationships between dampening mechanism components.

Abstract: Prosthetic medical devices with delayed valve function and in situ remodeling of a portion thereof are provided, as well as methods of manufacturing the medical devices and methods of treatment using the medical devices. The medical devices may be adapted to initially maintain a remodelable material within a body vessel in a first configuration suitable to contact the remodelable material with a body fluid contacting the remodelable material for a first time period or a second configuration adapted to regulate the flow of body fluid contacting the remodelable material. The medical devices may include a releasable holding member configured to retain the remodelable material in the first configuration.

Abstract: A heart valve prosthesis includes an annulus and a closing element having three leaflets. Hinge mechanisms are provided for attaching each leaflet to a top region of an interior surface of the annulus. In one example, the leaflets have convexo-concave surfaces and a non-uniform thickness. In another example, the top region of the interior surface has two sets of ledges which can be formed by intersecting three pairs of cylindrical surfaces. Ledges within each set are evenly spaced about the interior surface, a ledge in one set alternating with a ledge in the other set. In a further example, a bottom region of the interior surface is formed by intersecting three cylindrical surfaces.

Abstract: A device is presented for assisting an insufficient aortic valve. The device is configured as an auxiliary valve and comprises a resilient deformable sleeve-like valve, deformation of the sleeve-like valve shifting the valve between its closed and opened positions.

Abstract: There is disclosed a medical device adapted to be implanted in the heart of a patient and operable therein i) as a heart valve; or ii) to assist in the functioning of one of the patient's heart valves; or iii) to monitor the functioning of one of the patient's heart valves. The device includes one or more sensors for sensing a physiologically or clinically relevant parameter of a patient. A telemetric communication device telemetrically transmits data related to a parameter sensed by the sensor to a remote device.

Abstract: An implantable prosthesis can be formed from an improved biocompatible material that provides for cellular colonization of the biocompatible material. Specifically, the biocompatible material is a rigid porous material. In embodiments of particular interest, the implantable prosthesis is a mechanical heart valve prosthesis with a rigid occluder. In some embodiments, the rigid occluder is formed from the biocompatible material. A filler comprising a hydrogel or a structural protein can be located within the pores. In some embodiments, a bioactive agent is within the pores. In some embodiments, the rigid occluder is formed from a polymer material, a carbonaceous solid or a ceramic material. The pores can extend through the rigid material.

Abstract: An intraventricular apparatus includes an elongated body having a substantially tubular sidewall that extends substantially axially between spaced apart first and second ends, an opening located proximal the first end. A valve is located adjacent the first end to provide for substantially unidirectional flow of blood therethrough. At least one aperture extends through the tubular sidewall at an axial location between the valve and the second end to provide for substantially free flow of blood between an interior and an exterior of the sidewall.

Abstract: A valve shield comprising a shaped sheet of material adapted to be affixed to the annulus of a valve and adapted to extend over at least a portion of at least one leaflet of the valve so as to assist or replace the closing function of that valve leaflet.

Abstract: A prosthetic aortic valve is designed to be implanted in the natural aortic annulus and to extend into the ascending aorta to a point short of the right and left coronary arteries. Blood leakage around the valve is prevented by tension in one or more circumferential cords drawing annular tissue into sealing contact with an external sealing ring on the valve body. The security of the valve's attachment to a patient is assured with a plurality of interrupted sutures between a semirigid flange on the valve outer surface and the patient's aortic commissures and/or the patient's ascending aortic wall. The sutures are preferably attached to posts or cleats on the semirigid sewing flange, the flange being spaced apart from the valve inlet by the sealing ring.

Abstract: A tri-leaflet heart valve includes an annular valve base with an inner surface forming an orifice through which blood flows from the upstream side to the downstream side. Three protruding hinges, each with concave sockets on opposite sides, are formed on the inner surface. Each hinge has a downstream face and an upstream face connected by a ridge. Three leaflets are respectively arranged between adjacent hinges. Each leaflet has round pivots on both sides that rest inside the concave sockets, allowing the leaflets to freely rotate in the annular valve base. When the leaflets are subject to a positive pressure from the blood flow, the leaflets are pushed open and allow a central flow. When the leaflets are subject to a negative pressure, the leaflets are closed to occlude the blood flow.

Abstract: A multi-leaflet cardiovascular valve having a generally annular valve body (1) and at least two leaflets (4, 5) mounted within the valve body such that the leaflets rotate around a central axis (11) and a transverse pivoting axis (12) between an open configuration wherein blood is permitted to flow through the annular valve body and a closed configuration wherein blood is prevented from flowing in at least one direction through the annular valve body. During the open configuration, the leaflets rotate around the flow axis.

Abstract: A biocompatible heart valve is described having incorporated therein an effective amount of applied coating to render the valve resistant to in vivo pathologic thrombus formation and resistant to in vivo pathologic calcification.

Abstract: A mechanical heart valve prosthesis has a generally rectangular orifice and two leaflets that move between a closed position nearly perpendicular to blood flow and an open position nearly parallel to blood flow. Due to the uniform dimension of a rectangle, the leaflets are hinged at the periphery of the orifice, and present a single large central flow region to the blood when opened. The base provides several means of constraining the leaflet rotation during opening and closing.

Abstract: A heart valve prosthesis includes an annular body that has a fluid passageway and at least one rigid leaflet that is pivotally mounted in the passageway of the body. The leaflet is movable between a closed position wherein the fluid passageway is substantially closed and an open position wherein the fluid passageway is not substantially closed. The heart valve prosthesis has a biasing mechanism that is connected to the body and leaflet and is configured to exert a force on the leaflet to move the leaflet to the closed position before a second fluid pressure exerted on an outflow surface of the leaflet exceeds a first fluid pressure exerted on an inflow surface of the leaflet.

Abstract: An implantable prosthesis can be formed from an improved biocompatible material that provides for cellular colonization of the biocompatible material. Specifically, the biocompatible material is a rigid porous material. In embodiments of particular interest, the implantable prosthesis is a mechanical heart valve prosthesis with a rigid occluder. In some embodiments, the rigid occluder is formed from the biocompatible material. A filler comprising a hydrogel or a structural protein can be located within the pores. In some embodiments, a bioactive agent is within the pores. In some embodiments, the rigid occluder is formed from a polymer material, a carbonaceous solid or a ceramic material. The pores can extend through the rigid material.

Abstract: A mechanical heart valve and packaging wherein the mechanical valve is surrounded by a liquid. In one embodiment, a glutaraldehyde solution is used. In another embodiment, organic solvents are used. The liquid will not cause a particulate to form during storage. In addition, the liquid will not produce harmful changes in the polymeric sewing ring, for example. That is, the liquid does not cause degradation of the polymeric materials comprising the heart valve, nor does it cause swelling of such materials, nor the dissolution of polymeric materials.

Abstract: A heart valve prosthesis having a valve housing providing a lumen therethrough. The valve housing has a first annulus on one end and a second annulus on the other end spaced apart from the first annulus. A suture cuff is used for attaching the valve housing to heart tissue of a patient. The cuff is attached between the first annulus and the second annulus. The cuff is positioned such that prosthesis is attached in a supra-annular position relative to a tissue annulus of the heart. The design allows for an increased valve lumen.

Abstract: A bi-leaflet prosthetic heart valve, comprising an annular body having an upstream edge, a downstream edge and a passageway therebetween includes first and second leaflets pivotally mounted in the annular body. Each leaflet has an upstream edge, a downstream edge and a leaflet length therebetween. First and second pivot axes associated respectively with the first and second leaflets are provided and each leaflet rotates about its respective pivot axes between an open position allowing blood flow through the passageway of the annular body and a closed position blocking blood flow. The valve is configured such that the leaflets have an angle in the naturally open position of more than about 85°.