Abstract: A prosthetic heart valve for replacing a native valve includes a collapsible and expandable stent having a proximal end and a distal end, and a valve assembly including a plurality of leaflets, the valve assembly being disposed within the stent. The heart valve further includes a plurality of elongated legs each with a first end coupled to the stent and a free end, the elongated legs being configured to transition from an extended configuration to a relaxed configuration. A sealing portion connected to the plurality of legs forms a sealing structure when the legs transition to the relaxed configuration to reduce perivalvular leakage between the implanted valve and surrounding tissue.

Abstract: The invention is a system and method for accurately positioning a prosthetic valve such as a prosthetic heart valve at a desired position for deployment. The invention includes extendable positioning elements which provide tactile feedback to a user to confirm proper positioning of the catheter with respect to the native valve annulus. During delivery, the extendable positioning elements lie against the catheter, over the prosthetic valve and expandable balloon, providing a low profile for advancing the catheter to the desired treatment location via small passages such as body lumens. Prior to valve deployment, the positioning elements are extended and brought into contact with tissue of the native annulus to confirm the proper positioning of the delivery system and prosthetic valve.

Abstract: A vascular implant for replacing a native heart valve comprises a self expanding stent supporting a valve body having leaflets. The stent preferably comprises an anchoring structure configured to prevent the implant from passing through the valve annulus. For delivery, the implant is compacted within a delivery device and secured at one end. During delivery the implant is partially released from the delivery device, and positioning of the implant can be verified prior to full release. The implant can be at least partially resheathed and repositioned if desired.

Abstract: A vascular implant for replacing a native heart valve comprises a self expanding stent supporting a valve body having leaflets. The stent preferably comprises an anchoring structure configured to prevent the implant from passing through the valve annulus. For delivery, the implant is compacted within a delivery device and secured at one end. During delivery the implant is partially released from the delivery device, and positioning of the implant can be verified prior to full release. The implant can be at least partially resheathed and repositioned if desired.

Abstract: A device for heart valve replacement comprises a valve component having at least two valve leaflets preferably made of pericardium tissue. Each valve leaflet includes at least two tabs. The device further includes a stent component configured to be radially compressible into a compressed state and expandable into a functional state. The stent component comprises a first end, a second end and at least one intermediate section arranged between said first and said second end. The intermediate section has at least two commissural posts generally aligned parallel to an axis spanning from the first end to the second end. The commissural posts are formed in the shape of a wishbone.

Abstract: A vascular implant for replacing a native heart valve comprises a self expanding stent supporting a valve body having leaflets. The stent preferably comprises an anchoring structure configured to prevent the implant from passing through the valve annulus. For delivery, the implant is compacted within a delivery device and secured at one end. During delivery the implant is partially released from the delivery device, and positioning of the implant can be verified prior to full release. The implant can be at least partially resheathed and repositioned if desired.

Abstract: A method for percutaneously replacing a heart valve of a patient. In some embodiments the method includes the steps of percutaneously delivering a replacement valve and an expandable anchor to a vicinity of the heart valve in an unexpanded configuration; expanding the anchor to a deployed configuration in which the anchor contacts tissue at a first anchor site; repositioning the anchor to a second anchor site; and deploying the anchor at the second anchor site.

Abstract: Devices and methods for implantation at a native mitral valve having a non-circular annulus and leaflets. One embodiment of the device includes a valve support having a first region configured to be attached to a prosthetic valve with a plurality of prosthetic leaflets and a second region. The device can further include an anchoring member having a longitudinal dimension and including a first portion configured to contact tissue at the non-circular annulus, a second portion configured to be attached to the valve support, and a lateral portion between the first portion and the second portion. The second portion of the anchoring member is attached to the second region of the valve support while in a low-profile configuration in which the anchoring member and the valve support are configured to pass through vasculature of a human. The lateral portion is transverse to the longitudinal dimension.

Abstract: A heart valve prosthesis configured for placement at a mitral valve in the heart is disclosed that includes a stent-like support structure for supporting a prosthetic mitral valve. The support structure is configured to have a low ventricular profile with only a short length thereof protruding into the left ventricle when deployed in vivo. The support structure includes an upstream section that is outwardly expandable to sit against the atrial wall so as to at least partially anchor the prosthesis therein and a downstream section to which the prosthetic mitral valve is coupled that extends between the left atria and ventricle through the native mitral valve. The low-ventricular profile of the prosthesis is achieved by shaping the support structure such that the downstream section extends within and overlaps with the upstream section at given regions around the circumference of the support structure in an expanded configuration.

Abstract: Excessive dilation of the annulus of a mitral valve may lead to regurgitation of blood during ventricular contraction. This regurgitation may lead to a reduction in cardiac output. Disclosed are systems and methods relating to an implant configured for reshaping a mitral valve. The implant comprises a plurality of struts with anchors for tissue engagement. The implant is compressible to a first, reduced diameter for transluminal navigation and delivery to the left atrium of a heart. The implant may then expand to a second, enlarged diameter to embed its anchors to the tissue surrounding and/or including the mitral valve. The implant may then contract to a third, intermediate diameter, pulling the tissue radially inwardly, thereby reducing the mitral valve and lessening any of the associated symptoms including mitral regurgitation.

Abstract: Prosthetic valves and their component parts are described, as are prosthetic valve delivery devices and methods for their use. The prosthetic valves are particularly adapted for use in percutaneous aortic valve replacement procedures. The delivery devices are particularly adapted for use in minimally invasive surgical procedures.

Abstract: A prosthetic medical device is formed by the combination of a biological tissue a shape memory polymer structure. The biological tissue provides an in-situ physiological function of the device. The shape memory polymer provides a capability for minimizing the device profile during insertion and then deploying after placement into a memory shape that achieves suitable mechanical structure and stability within an anatomical lumen or cavity. This configuration may be applied to form various prosthetic devices including aortic, mitral, and tricuspid valves in the heart; venous valves; anti-reflux valves for the lower esophageal sphincter; and other biological valve structures. Alternatively, an entirely non-biologic implementation using only shape memory polymer-based structures may be used as a prosthetic valve device.

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: Disclosed herein are compositions and methods for treating or preventing a cardiac arrhythmia in a subject.

Abstract: A device for the transvascular implantation and fixation of prosthetic heart valves having a self-expanding heart valve stent (10) with a prosthetic heart valve (11) at its proximal end is introducible into a patient's main artery. With the objective of optimizing such a device to the extent that the prosthetic heart valve (11) can be implanted into a patient in a minimally-invasive procedure, to ensure optimal positioning accuracy of the prosthesis (11) in the patient's ventricle, the device includes a self-expanding positioning stent (20) introducible into an aortic valve positioned within a patient. The positioning stent is configured separately from the heart valve stent (10) so that the two stents respectively interact in their expanded states such that the heart valve stent (10) is held by the positioning stent (20) in a position in the patient's aorta relative the heart valve predefinable by the positioning stent (20).

Abstract: Devices and methods for implantation at a native mitral valve. One embodiment of the device includes a valve support having a first region and a second region, and anchoring member having a longitudinal dimension with a first portion configured to contact tissue at the non-circular annulus, a second portion configured to be attached to the valve support, and a lateral portion transverse to the longitudinal dimension between the first portion and the second portion. The anchoring member and the valve support are configured to move from a low-profile configuration to an expanded configuration in which the first portion of the anchoring member at least partially adapts to the non-circular annulus of the native mitral valve and a shape of the first region of the valve support is at least partially independent of a shape of the first portion of the anchoring member.

Abstract: An endoluminal support structure includes strut members interconnected by pivot joints to form a series of linked scissor mechanisms. The structure can be remotely actuated to compress or expand its shape by adjusting the scissor joints within a range of motion. In particular, the support structure can be repositioned within the body lumen or retrieved from the lumen. The support structure can be employed to introduce and support a prosthetic valve within a body lumen.

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

Abstract: A stent graft has a cylindrical wall, an internal lumen within the cylindrical wall and a fenestration in the wall. The fenestration is closed off by a valve arrangement to prevent the flow of liquids from within the internal lumen to outside of the wall. The valve arrangement is a tube of graft material which can be closed off by pressure on its outside surface. The end of the tube remote from the fenestration can be held shut by having its periphery fastened to a flattened resilient ring. Fluid pressure on the tube of graft material causes the tube to close off to prevent fluid flow therethrough and by resilient deflection of the resilient ring the end of the tube of graft material can be opened to enable the passing of a medical device therethrough.

Abstract: A prosthetic valve in the form of a flap valve which includes one or more flaps arranged to allow movement of liquid through the valve only in one direction, in which the or each flap is made of a flexible open work structure of a medically acceptable metal such as titanium or a titanium alloy.

Abstract: Methods, devices and systems are described for treating venous insufficiency in which the vein is compressed at least partially along a treatment zone. A system can be provided including an injection device, such as a glue gun, that is operably connected to a delivery catheter that can be advanced across a treatment zone in the vein. The delivery catheter can be used to deliver one, two, or more boluses of media (e.g., cyanoacrylate) to occlude the vein along different spaced-apart sections of the treatment zone. External compression can also be applied to the vein by a compression element, such as a hand or multifunctional ultrasound transducer, to occlude portions of the vein along the treatment zone prior to or during the introduction of the boluses of media.

Abstract: An endoluminal support structure includes strut members interconnected by pivot joints to form a series of linked scissor mechanisms. The structure can be remotely actuated to compress or expand its shape by adjusting the scissor joints within a range of motion. In particular, the support structure can be repositioned within the body lumen or retrieved from the lumen. The support structure can be employed to introduce and support a prosthetic valve within a body lumen.

Abstract: A quick-connect heart valve prosthesis that can be quickly and easily implanted during a surgical procedure is provided. The heart valve includes a substantially non-expandable, non-compressible prosthetic valve and a plastically-expandable coupling stent, thereby enabling attachment to the annulus without sutures. A small number of guide sutures may be provided for aortic valve orientation. The prosthetic valve may be a commercially available valve with a sewing ring with the coupling stent attached thereto. The coupling stent may expand from a conical deployment shape to a conical expanded shape, and may include web-like struts connected between axially-extending posts. A system and method for deployment includes a hollow two-piece handle through which a balloon catheter passes. A valve holder is stored with the heart valve and the handle easily attaches thereto to improve valve preparation steps.

Abstract: Biomedical valve devices, support frames for use in such devices, methods of making such devices, and methods of treating animals, including humans, for valve-related conditions are described. The biomedical valve devices can includes a native tissue valve attached to a support frame or a tissue attached to a support frame in a manner to form a valve. The tissue valve or tissue can be autogenous to the animal being treated.

Abstract: This invention relates to prosthetic cardiac and venous valves and a single catheter device and minimally invasive techniques for percutaneous and transluminal valvuloplasty and prosthetic valve implantation.

Abstract: A prosthetic valve assembly for use in replacing a deficient native valve comprises a replacement valve supported on an expandable valve support. The valve support, which entirely supports the valve annulus, valve leaflets, and valve commissure points, is configured to be collapsible for transluminal delivery and expandable contact the anatomical annulus of the native valve when the assembly is properly positioned. Portions of the valve support may expand to a preset diameter to maintain coaptivity of the replacement valve and to prevent occlusion of the coronary ostia.

Abstract: A stent comprised of a valve and a scaffolding structure having components configured to allow at least a portion of the stent to decrease in diameter in response to an axial force applied to the stent. Further, the components and elements of the stent may be configured to balance transverse forces applied to the stent, thus reducing the incidence of infolding.

Abstract: An implantable device for regulating blood flow through a blood vessel includes an elongated support. The support includes axially spaced apart first and second substantially annular support portions, and an x-shaped linking member linking the axially spaced apart portions to one another. The device also includes a valve membrane extending between the axially spaced apart support portions and having an upper portion, a lower portion and an intermediate portion. The valve membrane includes a first region and a second lower region. The first region is folded over the linking member for attachment and the second region is adjacent the first region and unattached to the linking member. The second region is movable between a first position to enable blood flow and a second position to inhibit blood flow.

Abstract: The present embodiments provide a stent graft having a tubular configuration defining a lumen therethrough, the stent graft having a proximal section and a distal section. A folded section is positioned between the proximal section and the distal section. The folded section includes a first fold directed toward the distal end and engaged with the proximal section and a second fold directed toward the proximal end and engaged with the distal section. A valve arrangement is positioned in at least one of the first and second folds providing access from an exterior of the graft to the interior of the stent graft for insertion of an additional device.

Abstract: An implantable flow adjuster (20) includes proximal and distal support rings (22, 24) which support a flow adjuster panel (26). The flow adjuster panel (26) divides the lumen through the device (20) into two sections, one of reducing cross sectional area and the other of increasing of increasing cross sectional area. The two sections (40, 42) cause, respectively, an increase in blood pressure and blood flow and a decrease in blood pressure and blood flow. These result is a pressure differential beyond the distal end of the device (20). This pressure differential can be used to divert blood flow away from the neck (14) into an aneurysm (12), thus to reduce pressure and wall sheer stress within the aneurysm in order to assist in the repair of the vessel.

Abstract: This disclosure includes embodiments of vascular prosthetic assemblies (e.g., heart valves) and methods for using (e.g., percutaneously) and manufacturing (e.g., overmolding) the assemblies. In one embodiment, a vascular prosthetic assembly comprises a frame and a cellulose-based body coupled to the frame, wherein the frame is configured to be altered from an expanded configuration to a collapsed configuration. The frame can be biased toward the expanded configuration, and the assembly can be configured for placement within a catheter when the frame is in the collapsed configuration. In the embodiment shown, the frame can comprise any number of biocompatible materials, including, but not limited to, nitinol. Stainless steel, or cobalt chromium.

Abstract: A medical device used in patients with inefficient heart function to improve the efficiency of the pumping action of the heart. This device adds one or more one-way valves in the blood vessels and/or arteries, very near, but not in, the heart, thereby increasing the efficiency of the native heart. The device includes one or more one-way heart valves designed to go in arteries/veins that are connected to the heart, and which arteries and/or veins are the conduits for taking blood into/out of the heart. The one-way heart valve allows blood flow in only one direction. An optional sleeve (stent) may be placed outside the arteries/veins where the valve(s) are located to add support to the walls. An optional sleeve (stent) may also be used on the inside of the artery to insure the artery does not collapse during a vacuum phase of the beating.

Abstract: Devices and methods for assisting valve function, replacing venous valves, and predicting valve treatment successes. In at least one exemplary embodiment of an endograft body configured for expansion within a luminal organ of the present disclosure, the endograft body comprises (a) a first portion having a proximal end defining a proximal end aperture and a distal end defining a distal end aperture, the first portion configured to increase a velocity of fluid flowing therethrough, (b) a second portion having a second portion proximal end defining a second portion proximal end aperture and a second portion distal end defining a second portion distal end aperture.

Abstract: A reperfusion system and method of perfusing a blood vessel using the reperfusion system are provided. The system includes an introducer sheath, a middle catheter extending through the introducer sheath, and a balloon microcatheter extending through the middle catheter. A connecting tube extends between a lumen of the introducer sheath and a valve at a proximal end of the microcatheter. A flow path is defined along a lumen of the introducer sheath, through the connecting tube, into the microcatheter, and out of a distal opening of the microcatheter. The balloon is disposed adjacent the exit point of the flow path to reduce reflux. Embolic material can be introduced into the microcatheter at the valve to exit at the same location as the blood flow.

Abstract: A collapsible prosthetic heart valve includes a stent and a valve assembly. The stent has a proximal end and a distal end and includes a plurality of struts. The struts have free ends configured to inhibit tissue penetration. The valve assembly, including a plurality of leaflets, is disposed within the stent.

Abstract: A prosthetic aortic conduit (1) for use during surgery on the aorta of a patient. The conduit includes an elongate tubular portion (10) extending along a longitudinal axis (11) between a first conduit terminal end (12) and a second conduit terminal end (13). The first conduit terminal end (12) is configured with two substantially U-shaped tongues (21, 22) extending away from the tubular portion (10) generally along the longitudinal axis (11). Each of the tongues (21, 22) is appropriately sized to together collectively approximate the shape of the scalloped bicuspid valve annulus. The second conduit terminal end (13) is configured with three substantially U-shaped tongues (31, 32, 33) extending away from the tubular portion (10) generally along the longitudinal axis (11). Each of the tongues (31, 32, 33) is appropriately sized to together collectively approximate the shape of the scalloped tricuspid valve annulus.

Abstract: A heart valve prosthesis configured for deployment within a native heart valve. The heart valve prosthesis includes a tubular stent and a prosthetic valve component disposed within and secured to the stent. In addition, one or more elements are coupled to a distal end of the stent to position, anchor, and/or seal the prosthesis within the native heart valve. Each element transforms from a compressed configuration in which the elements distally extend from the distal end of the stent to a deployed configuration in which the elements proximally extend from the distal end of the stent. Each element includes at least one U-shaped or V-shaped support arm that bends radially outward and then towards an outer surface of the stent such that it translates more than ninety degrees from the compressed configuration. Each element may include an outer support arm and an inner support arm.

Abstract: Embodiments of an apparatus for treating a deficient mitral valve include an expandable spacer configured for placement between the native leaflets of the mitral valve, the spacer anchorable to a wall of the ventricle. Methods and apparatus for delivering and implanting the prosthetic are also described.

Abstract: A medical implant (20) includes first and second ring members (22, 24), each including a resilient framework (26) having a generally cylindrical form. A tubular sleeve (28) is fixed to the first and second ring members so as to hold the ring members in mutual longitudinal alignment, thereby defining a lumen (32) passing through the ring members. A constricting element (30) is fit around the sleeve at a location intermediate the first and second ring members so as to reduce a diameter of the lumen at the location.

Abstract: A medical treatment system and method of treatment is described having an implant that can be positioned and deployed, then undeployed to allow repositioning of the implant. The system includes a self-expanding medical implant that longitudinally foreshortens upon radially expanding from a radially compacted state, a distal interface configured to attach the implant to a distal mount of a delivery device, and a proximal interface configured to attach the implant to a proximal mount of the delivery device. Moving the distal mount longitudinally away from the proximal mount applies a longitudinal tension to the implant causing the implant to expand longitudinally and contract radially, and moving the distal mount toward the proximal mount reduces a longitudinal tension in the implant allowing the implant to expand radially toward a fully expanded state.

Abstract: The invention includes a medical device and more specifically relates to a valve found generally within a frame. In a preferred device, the frame preferably comprises a self-expanding stent frame, and the valve has at least one expandable and contractible pocket member within the stent frame for resisting and permitting fluid flow, respectively.

Abstract: Described, in certain aspects of the invention, are apparatuses and methods for deploying artificial devices within the vascular system. One apparatus includes a delivery device having a lumen and a deployment member slidably received within the lumen. This apparatus further includes an artificial device having an anchoring element releasably engaged with the deployment member. Such an apparatus can be percutaneously delivered to a site within a vascular vessel, and thereafter manipulated so that the anchoring element attaches to the vessel wall. The delivery device and deployment member can then be withdrawn from the vessel, whereby the deployment member disengages from the anchoring element, leaving the artificial device implanted in the vessel.

Abstract: A method of treating a native heart valve includes delivering a replacement valve to the native heart valve. The native heart valve can be any one of aortic, pulmonary, mitral and tricuspid valves. The replacement valve comprising an expandable frame and a valve body attached to the expandable frame. The method can also include expanding the frame at a patient's valve annulus, wherein expansion of the frame causes respective ends of both proximal anchors and distal anchors connected to the frame to draw closer together to grasp native tissue between the respective ends of the proximal anchors and distal anchors.

Abstract: A two valve caval stent for functional replacement of an incompetent tricuspid valve. The device is designed for minimally invasive percutaneous transcatheter placement and includes two stents connected by a bridge sized to span the right atrium, and two valves anchored by the stents in the superior and inferior vena cavas. Each of the valves optionally has a conical shape divided by supporting struts into three cusps that simulate the action of a native tricuspid valve.

Abstract: A stent is provided that is able to resist clogging from cumulative matter found within a fluid that passes therethrough. The stent includes a mass moveably disposed therein, wherein movement of the stent tends to dislodge any cumulative matter accumulated within the stent. As a result, the device is able to remain resident within the patient for an extended period of time before becoming clogged and needing to be replaced.

Abstract: A medicinal device with a tubular wall made of webs which delimit the cells, and a flexible membrane which forms at least one flap which has a first end connected to at least one first web of a cell, and a free second end which is disposed opposite the first end in the longitudinal direction of the flap. The flap, in the closed position, extends along the tubular wall and at least partially closes the cells, and can be moved to an open position in which the flap is radially deviated in relation to the wall in order to open the cells in a valve-like manner.

Abstract: A heart valve prosthesis has a supported valve including a biological valve portion mounted within a support structure. The supported valve has inflow and outflow ends spaced axially apart from each other. A fixation support member includes an inflow portion that extends from a radially inner contact surface of the fixation support member radially outwardly and axially in a direction of the inflow end of the supported valve. An outflow portion of the fixation support member extends from the radially inner contact surface radially outwardly and axially in a direction away from the inflow portion of the fixation support member. The radially inner contact surface is attached to a radially outer surface of the supported valve adjacent the inflow end of the supported valve.

Abstract: A device for the transvascular implantation and fixation of prosthetic heart valves having a self-expanding heart valve stent (10) with a prosthetic heart valve (11) at its proximal end is introducible into a patient's main artery. With the objective of optimizing such a device to the extent that the prosthetic heart valve (11) can be implanted into a patient in a minimally-invasive procedure, to ensure optimal positioning accuracy of the prosthesis (11) in the patient's ventricle, the device includes a self-expanding positioning stent (20) introducible into an aortic valve positioned within a patient. The positioning stunt is configured separately from the heart valve stent (10) so that the two stents respectively interact in their expanded states such that the heart valve stent (10) is held by the positioning stent (20) in a position in the patient's aorta relative the heart valve predefinable by the positioning stent (20).

Abstract: A heart valve prosthesis includes an expandable prosthetic valve including three valve leaflets coupled to an anchoring structure. The anchoring structure includes an annular member and a plurality of arms movably coupled to the annular member at one end. The free ends of the arms extend radially away from the prosthesis toward a valve annulus. The arms are configured to fit in a space defined between an open native valve leaflet and a wall of a valve sinus. The arms are sufficiently resilient such that they resist downward movement in response to pressure exerted on the prosthesis, facilitating anchorage and stabilization of the prosthesis at the implantation site.

Abstract: A vascular device comprising a body movable from a collapsed insertion position to an expanded position having a larger cross-sectional dimension. The body includes a plurality of struts. At least two elongated struts extend distally from the body. A plurality of vessel engaging members extend outwardly from the body for engaging the internal wall of a vessel. A valve is movable between a collapsed delivery position and an expanded placement position, wherein at least a portion of the valve extends distally from the body in the delivery and placement positions and the elongated struts engage a distal portion of the valve in the placement position of the valve to retain the valve.