Abstract: A system for implanting a repair device onto a native valve of a natural heart to repair the native valve of a patient during a non-open-heart procedure. The system includes a base assembly having a plurality of pivoting links, a pair of paddles attached to the base assembly, a pair of gripping members attached to the base assembly, and at least one coaptation or spacer element disposed between the pair of gripping members. Movement of the pivoting links of the base assembly causes the paddles to move between an open position and a closed position. The paddles and the gripping members are configured to attach to valve leaflets of the patient. The coaptation or spacer element is configured to fill at least a portion of a gap between the valve leaflets of the patient.

Abstract: A system for implanting a repair device onto a native valve of a natural heart to repairing the native valve of a patient during a non-open-heart procedure. The system includes a pair of paddles and a pair of gripping members. The paddles are movable between an open position and a closed position. Each of the gripping members has a barbed portion for securing the gripping members to the native valve of a patient. Each gripping member is slidably attached to a corresponding paddle. Each gripping member can be moved in a first direction along the paddle before the barbed portion of the gripping member pierces the native valve of the patient. Each gripping member can be moved in a direction substantially opposite the first direction after the barbed portion pierces the native valve of the patient such that the gripping members create a tensioning force on the native valve of the patient.

Abstract: A system for implanting a repair device onto a native valve of a natural heart to repairing the native valve of a patient during a non-open-heart procedure. The system includes a pair of paddles and a pair of gripping members. The paddles are moveable between an open position and a closed position. The gripping members can have different configurations for effective attachment and release from the native valve of the patient.

Abstract: A system for implanting a repair device onto a native valve of a natural heart to repairing the native valve of a patient during a non-open-heart procedure. The system includes a surgical delivery instrument, a valve repair device, and a gripper control mechanism. The surgical delivery instrument has at least one lumen. The valve repair device is configured to be delivered through the lumen of the surgical delivery instrument and to be attached to a native valve of a patient. The valve repair device has a pair of paddles, and first and second gripping members. The paddles are movable between an open position and a closed position. The paddles and the first and second gripping members are configured to attach to the native valve of the patient. The gripper control mechanisms each include a suture and a wire having a loop at a distal end. The suture extends from the surgical delivery instrument and through the loop of the wire. The suture is removably attached to the gripping member.

Abstract: A system for implanting a repair device onto a native valve of a natural heart to repair the native valve of a patient during a non-open-heart procedure. The system includes a pair of paddles and a pair of gripping members. The paddles are movable between an open position and a closed position. The paddles and the gripping members are configured to attach to the native valve of the patient. The paddles are biased to the closed position, latched to the gripping members in the closed position, maintained in the closed position by a threaded connection, or otherwise maintained in the closed position.

Abstract: A system for implanting a repair device onto a native valve of a natural heart to repairing the native valve of a patient during a non-open-heart procedure. The system includes a surgical delivery instrument, a valve repair device, and a gripper control mechanism. The surgical delivery instrument has at least one lumen. The valve repair device is configured to be delivered through the lumen of the surgical delivery instrument and to be attached to a native valve of a patient. The valve repair device includes a pair of paddles, and at least four gripping members. The paddles are movable between an open position and a closed position, and the paddles and the at least four gripping members are configured to attach to the native valve of a patient. The gripper control mechanism is configured to independently move each of the at least four gripping members.

Abstract: A method of making a replacement heart valve device whereby a fragment of biocompatible tissue material is treated and soaked in one or more alcohol solutions and a solution of glutaraldehyde. The dried biocompatible tissue material is folded and rehydrated in such a way that forms a two- or three-leaflet/cusp valve without affixing of separate cusps or leaflets or cutting slits into the biocompatible tissue material to form the cusps or leaflets. After the biocompatible tissue material is folded, it is affixed at one or more points on the outer surface to the inner cavity or a stent.

Abstract: A personalized prosthetic valve for implantation at a native valve treatment site includes a self-expanding mesh and a plurality of valve leaflets coupled to the mesh. The mesh may be delivered to the native valve in a collapsed configuration, and in an expanded configuration the mesh engages the native valve. The mesh in the expanded configuration is also personalized to match the treatment site, such that the outer mesh surface substantially matches the treatment site shape and size. The self-expanding mesh forms a central lumen configured to allow blood or other body fluids to pass therethrough. In the open configuration, blood passes through the prosthetic valve, and in the closed configuration, the plurality of leaflets are closer together and blood is prevented from flowing upstream through the prosthetic valve.

Abstract: A method of assembling an electronic prosthetic aortic valve is provided. The method includes inserting an electronics component into a valve component, the electronics component including one or more electrodes and a prosthetic-valve coil, and the valve component including a frame and prosthetic leaflets coupled to the frame; and coupling the electronics component to the valve component. Other embodiments are also described.

Abstract: A prosthetic heart valve for replacing a native valve includes a stent extending between a proximal end and a distal end and including a plurality of struts forming cells, the stent having a collapsed condition and an expanded condition. At least one runner is coupled a cell, the at least one runner being configured to transition from a first configuration to a second configuration when the stent moves from the collapsed condition to the expanded condition, the at least one runner projecting radially outwardly from the cell in the second configuration. A valve assembly is disposed within the stent, the valve assembly including a plurality of leaflets, a cuff at least partially disposed on a luminal surface of the stent, and a covering material disposed on an abluminal surface of the stent and covering the at least one runner in the second configuration.

Abstract: A prosthetic valve, solving the technical problem of an existing prosthetic valve, when implanted in a certain valve site, not being adaptive to the physiological anatomy condition of the heart, being difficult to mount and fix properly and being easy to become displaced, and consequently affecting the function of the valve. The prosthetic valve comprises an annular frame (2) which has a mesh structure and can radially expand to deform; a connection line (10) is provided on the frame (2); the prosthetic valve is connected and fixed to an anatomical structure of a mounting position of a human body by means of the connection line (10); the connection line (10) surrounds the outside of the frame (2) to form several connection portions which extend out along the radial direction of the frame (2); the space surrounded by the connection portions can receive the thickness of the anatomical structure.

Abstract: A system for implanting a repair device onto a native valve of a natural heart to repairing the native valve of a patient during a non-open-heart procedure. The system includes a paddle and a gripping member. The paddle is movable between an open position and a closed position. The gripping member has a weakened portion and a barbed portion. The barbed portion is configured to secure the gripping member to valve tissue of the native valve of the patient. A gripper control mechanism is configured to move the gripping member between an open position and a closed position. The gripper control mechanism comprises a suture removably attached to the gripping member at a first connection point and a pushing member configured to engage the gripping member at a second connection point. The weakened portion is between the first and second connection points.

Abstract: Devices and methods for retrieving percutaneously implanted catheter systems such as a heart valve repair system. The devices include at least one locking connector at the distal end of a flexible elongated extension for coupling to an implanted tubular member. The locking connector may be a tubular anchor having a pair of distal prongs which are biased outward and face in a proximal direction, as well as an expandable auxetic midsection. Inserting the tubular anchor into the implanted tubular member flexes the distal prongs inward such that they prevent proximal movement of the tubular anchor. A user pulls on the proximal end of the tubular anchor to expand the auxetic midsection and lock the two pieces together. The devices and methods are particularly useful to attach extensions to implanted concentric tubes to enable relative axial force application.

Abstract: A system for implanting a repair device onto a native valve of a natural heart to repair the native valve of a patient during a non-open-heart procedure. The system includes a surgical a valve repair device for repairing a native valve of a patient including a pair of paddles, and a pair of gripping members. The paddles are movable between an open position and a closed position, in which the paddles are moved to the open position by moving a pivot point of each paddle in an outward direction and pivoting each of the paddles about the pivot point of the paddle. The paddles and the gripping members are configured to attach to the native valve of the patient when the paddles are in the closed position.

Abstract: Embodiments hereof relate to centering devices for use with a valve delivery system and methods of delivering a valve prosthesis within a vasculature. A valve centering catheter is configured for use with a valve delivery system. The valve centering catheter includes a circumferential centering device at a distal portion thereof, and the circumferential centering device defines a central opening there-through when in an expanded configuration. The circumferential centering device is annular or has a C-shaped cross-section. The valve delivery system is tracked through the vasculature until the valve prosthesis is positioned through the central opening of the expanded circumferential centering device. The valve centering catheter may alternatively include a longitudinal centering device which acts as a marker for depth control during delivery of a valve delivery system, which may include an integral circumferential centering device.

Abstract: A system for repairing a native heart valve can comprise a first fastener, a second faster, a first leaflet brace, and a second leaflet brace. The first leaflet brace can be configured to extend partially around a first native leaflet. The second leaflet brace can be configured to extend partially around a second native leaflet. The first fastener can be configured to be deployed on respective first end portions of the first and second braces so as to connect the first end portions to each other. The second fastener can be configured to be deployed on respective second end portions of the first and second braces so as to connect the second end portions to each other. When the first end portions are connected to each other and the second end portions are connected to each other, the first and second leaflet braces encircle the first and second native leaflets.

Abstract: Certain embodiments of the present disclosure provide a prosthetic valve (e.g., prosthetic heart valve) and a valve delivery apparatus for delivery of the prosthetic valve to a native valve site via the human vasculature. The prosthetic valve comprises a frame or stent that comprises multiple cells arranged in unique ways. The prosthetic valve also comprises a leaflet assembly coupled to the frame and having a plurality of leaflets, wherein the leaflets are configured to allow blood to flow through the prosthetic heart valve in one direction from an inflow end portion to an outflow end portion of the frame or stent.

Abstract: The present disclosure relates to heart valve prostheses, delivery devices, actuation handles, and other improved devices and methods that facilitate delivery of a heart valve prosthesis to a defective native valve structure in a patient, such as the aortic valve.

Abstract: The present disclosure relates to heart valve prostheses, delivery devices, actuation handles, and other improved devices and methods that facilitate delivery of a heart valve prosthesis to a defective native valve structure in a patient, such as the aortic valve.

Abstract: The present disclosure relates to heart valve prostheses, delivery devices, actuation handles, and other improved devices and methods that facilitate delivery of a heart valve prosthesis to a defective native valve structure in a patient, such as the aortic valve.

Abstract: The present disclosure relates to heart valve prostheses, delivery devices, actuation handles, and other improved devices and methods that facilitate delivery of a heart valve prosthesis to a defective native valve structure in a patient, such as the aortic valve.

Abstract: The present disclosure relates to heart valve prostheses, delivery devices, actuation handles, and other improved devices and methods that facilitate delivery of a heart valve prosthesis to a defective native valve structure in a patient, such as the aortic valve.

Abstract: The present disclosure relates to heart valve prostheses, delivery devices, actuation handles, and other improved devices and methods that facilitate delivery of a heart valve prosthesis to a defective native valve structure in a patient, such as the aortic valve.

Abstract: A valve prosthesis and a system for delivering a valve prosthesis are described herein. The system can include a core member and an engagement mechanism for releasably engaging a radially expandable valve anchor of the valve prosthesis along the core member. The engagement mechanism can include a pin assembly slidably coupled to the core member and a nose cone including a lock component slidably coupled along the core member to permit the valve anchor to disengage from the pin assembly.

Abstract: Methods of assembling and delivering a valve prosthesis and delivery system are disclosed herein. A method can include housing a valve prosthesis in a compacted state within a sheath of a delivery system. The valve prosthesis can include a valve anchor and a support frame coupled to the valve anchor, and the valve anchor can include a plurality of anchoring legs having a plurality of connection apertures. The method can further include slidably coupling a pin assembly around a core member so that the pin assembly is slidable longitudinally along the core member, and inserting a plurality of pins of the pin assembly through the plurality of connection apertures of the valve anchor and a plurality of lock apertures of the delivery system to engage the plurality of anchoring legs of the valve anchor.

Abstract: A prosthetic heart valve, and associated methods therefore, configured to replace a native heart valve, and having a support frame configured to be reshaped into an expanded form in order to receive and/or support an expandable prosthetic heart valve therein. The prosthetic heart valve may be configured to have a generally rigid and/or expansion-resistant configuration when initially implanted to replace a native valve (or other prosthetic heart valve), but to assume a generally non-rigid and/or expanded/expandable form when subjected to an outward force such as that provided by a dilation balloon.

Abstract: An annuloplasty device formed from a Nitinol stent frame that expands into contact with the annulus above the native leaflets. A torus balloon activates barbs along the perimeter to fasten the stent frame to the annulus. A cinch ring is placed under tension to reduce the perimeter of the stent frame. The cinch ring and torus balloon are implanted along with the stent frame.

Abstract: An annuloplasty repair segment for heart valve annulus repair and a method for forming. A multi-stranded cable replaces solid core wire for both the tricuspid and mitral valves which allows for greater deployment flexibility for minimally-invasive surgical (MIS) implant, while still maintaining the required strength and similar tensile properties of solid-core wire. The particular shape of the annuloplasty ring is fixed using a heat setting process including heating the flexible core member to a temperature higher than 500° C. and holding it in a desired heat-set saddle shape for a period of time. The core is then rapidly cooled to impart physical properties such that the flexible core member can be straightened, during implantation, to fit through a tubular access device and regain the heat-set saddle shape after exiting the access device and, when attached to the native heart valve, the flexible core member is strong enough to remodel the native heart valve.

Abstract: Disclosed herein are devices for improving coaption of the mitral valve leaflets to reduce or eliminate mitral valve regurgitation. The devices may be used to perform mitral valve annuloplasty, or to serve as a docking station for a transcatheter prosthetic heart valve. The various embodiments of devices are configured for percutaneous and, in some cases, transvascular delivery. Delivery systems useful for routing the devices to the mitral valve are also disclosed, including catheters, balloons and/or mechanical expansion systems. The devices themselves include at least one tissue penetrating member. Methods of delivery include partially embedding the devices in the mitral valve annulus via at least one tissue penetrating member. Tissue penetrating members may be embedded into the tissue in a simultaneous or a nearly simultaneous fashion. Upon embedding, the devices employ various expansion and/or contraction features to adjust the mitral valve diameter.

Abstract: A system for implanting a repair device onto a native valve of a natural heart to repair the native valve of a patient during a non-open-heart procedure. The system includes a surgical delivery instrument, a valve repair device, and a gripper control mechanism. The surgical delivery instrument has at least one lumen. The valve repair device is configured to be delivered through the lumen of the surgical delivery instrument and to attach to a native valve of a patient. The valve repair device includes a pair of paddles, and a pair of gripping members. The paddles are movable between an open position and a closed position. The paddles and the gripping members are configured to attach to a native valve of the patient. The gripper control mechanism is configured to independently move the first and second gripping members.

Abstract: A system for implanting a repair device onto a native valve of a natural heart to repair the native valve of a patient during a non-open-heart procedure. The system includes a surgical delivery instrument and a valve repair device. The surgical delivery instrument has at least one lumen. The valve repair device is configured to be delivered through the lumen of the surgical delivery instrument and to be attached to a native valve of a patient. The valve repair device includes a pair of paddles and a pair of gripping members. The paddles are movable between an open position and a closed position, and the paddles are configured to flex upon being attached to the native valve of a patient. The paddles and the gripping members are configured to attach to the native valve of the patient.

Abstract: Two minimally invasive therapeutic procedures, particularly for patients with congestive heart failure, may be performed separately or together. 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. 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. Improved devices for these procedures include a minimally invasive grasping device for heart leaflets, a leaflet connector with artificial cordae tendenae and a pacing lead implant instrument.

Abstract: Embodiments of the present disclosure include a method of transcatheterly delivering a band to encircle multiple papillary muscles in a heart. The method may comprise transcutaneously inserting a catheter into a heart and delivering a first end of a first guidewire to a ventricle in the heart via the catheter. The method may further comprise looping a first end of a first guidewire around a first papillary muscle and a second end of a second guidewire around a second papillary muscle. The first end of the first guidewire and the second end of the second guidewire may be brought out of the body while the first and second guidewires remain looped around the first and second papillary muscles, respectively. The first and second guidewires may be interconnected, and at least one end of the first and second guidewires may be pulled to establish a single loop around the papillary muscles.

Abstract: An implant for repairing a segmental defect in a subject's bone at a segmental defect site, the implant comprising a scaffold for implantation at the segmental defect site and the implant optionally comprising: a plate for internal fixation, the plate being attachable to or integral with the scaffold, and the plate having means for securing it to bone outside of the segmental defect site; a hollow cavity within the scaffold; a plurality of longitudinal channels within the scaffold; and or a membrane received around the scaffold.

Abstract: A universal low-profile intercranial assembly includes a mounting plate and a low profile intercranial device composed of a static cranial implant and an interdigitating functional neurosurgical implant. The low profile intercranial device is shaped and dimensioned for mounted to the mounting plate.

Abstract: The augments, systems and methods for supporting acetabular implants described herein can include an augment (100) for supporting an acetabular shell (90) having a first portion (136) of a locking mechanism. The system can also include a shell having a second portion of a locking mechanism (96). The first portion of the locking mechanism and the second portion of the locking mechanism can be adapted to move relative to one another from an unlocked state to a locked state to fixedly couple the augment to the shell. In some examples, the augment can be contourable to match the shape of a bone.

Abstract: The present invention relates to an implant (10) comprising an implant body having a first surface area (A1, A2, A3, A4) configured for contact with soft connective tissue and a second surface area configured for contact with bone tissue, wherein the first surface area is covered with a coating comprising tantalum and the second surface area is formed by a material, which is different than the one forming the coating.

Abstract: A method of manufacturing at least one component of a joint prosthesis, the method comprising creating a first database representing an anatomy of an articulating bone of a joint of a subject; accessing a second database representing a geometry of a generic prosthetic component being sized to fit around an outer articulating surface of the articulating bone of the joint of the subject; creating a third database representing kinematic data of the subject's joint; merging the databases within a three-dimensional image-based medium. The generic prosthetic component is attached to the outer articulating surface of the articulating bone of the joint creating a prosthetic articulating surface that is moved through the kinematic data of the subject through a bearing template thereby modifying the bearing template to create a kinematically appropriate bearing surface; and manufacturing the component of the joint prosthesis to have a geometry corresponding to the kinematically appropriate bearing surface.

Abstract: A modular femoral prosthesis system for an orthopaedic hip implant and method of use is disclosed. The prosthesis system includes a femoral stem component and a plurality of collar components configured to be selectively coupled to the stem component in a fixed position adjacent to a neck of the stem component. Each of the collar components includes a base and is configured to secure an assembled femoral prosthesis to a patient's surgically prepared femur to provide stability for the assembled femoral prosthesis.

Abstract: According to one example, a tibial bearing component for articulation with a medial condyle and a lateral condyle of a femoral component in a knee replacement procedure is disclosed. The tibial bearing component can include a distal surface and an articular surface opposing the distal surface. The articular surface can include a medial compartment and a lateral compartment configured for articulation with the medial condyle and the lateral condyle of the femoral component, respectively. The lateral compartment can have a lateral articular track with a lateral anterior-posterior extent. The lateral articular track can comprise a plurality of distal-most points along a proximal surface of the lateral compartment that are contacted by the lateral condyle during rollback of the femoral component. The medial compartment can differ in configuration from the lateral compartment and can have an anterior lip height of between about 9 mm and about 13 mm.

Abstract: A subtalar implant that can be expanded/contracted in vivo to adjust the amount of distraction applied to the subtalar joint of a patient and a related insertion device are disclosed herein. More specifically, the subtalar implant can expand both radially and also in the angle between the proximal and distal end of the outer component of the implant. The implant comprises an internal component that allows for the distal or proximal ends of the implant to be manipulated via the insertion device. The subtalar implant and the related insertion device permit a surgeon to adjust the implant construct to suit a particular patient.

Abstract: A spinal construct includes a first endplate that is configured to engage a first vertebral surface. An expandable member is connected with the first endplate and includes a mating element. A second endplate is configured to engage a second vertebral surface and includes an in-situ guide surface engageable with the mating element to connect the member with the second endplate. Systems and methods are disclosed.

Abstract: An expandable intervertebral implant, including an inferior component, including a first plate, a second plate connected to the first plate and including a first plurality of locking apertures, and a third plate connected to the first plate and including a second plurality of locking apertures, a superior component slidingly engaged with the inferior component, including, a fourth plate, a fifth plate connected to the fourth plate and including a third locking aperture, and a sixth plate connected to the fourth plate and including a fourth locking aperture, and a locking pin assembly arranged at least partially in the third and fourth locking apertures, and operatively arranged to engage the first and second pluralities of locking apertures to lock the inferior component to the superior component.

Abstract: Spinal implants are disclosed. One spinal implant includes a support body, an articulating element, a blocking member and a motion limiting member. The support body includes a superior end surface and a lower end surface having teeth. In between the superior end surface and the lower end surface is a recess formed in a sidewall of the support body for receiving the articulating element. The blocking member can be received in the recess to prevent inadvertent back-out of the articulating element from within the recess. The articulating element can articulate in one or more directions, thereby allowing articulation of the spinal implant into a desired position within a disc space.

Abstract: According to some embodiments, a method of inserting a lateral implant within an intervertebral space defined between an upper vertebral member and a lower vertebral member includes creating a lateral passage through a subject in order to provide minimally invasive access to the intervertebral space, at least partially clearing out native tissue of the subject within and/or near the intervertebral space, positioning a base plate within the intervertebral space, wherein the base plate comprise an upper base plate and a lower base plate and advancing an implant between the upper base plate and the lower base plate so that the implant is urged into the intervertebral space and the upper vertebral member is distracted relative to the lower vertebral member.

Abstract: An intervertebral scaffolding system is provided having a laterovertically-expanding frame operable for a reversible collapse from an expanded state into a collapsed state, the laterovertically-expanding frame having a stabilizer, one or more tensioners, or a combination of the stabilizer with one or more tensioners. The stabilizer slidably engages with the distal region of the laterovertically-expanding frame and both the stabilizer and the one or more tensioners are configured for retaining the laterovertically-expanding frame from a lateral movement that exceeds the expanded state, and the stabilizer can include a locking element that engages with the expansion member to lock the expansion member to the stabilizer when the expansion member is fully inserted into the frame. The expanded state, for example, can be configured to have an open graft distribution window that at least substantially closes upon the reversible collapse.

Abstract: A device for delivering a bone material to a surgical site is provided. The device comprises a body having an upper portion and a lower portion. The lower portion of the body is substantially transverse to the upper portion and has an opening for receiving a bone material. An internal chamber is disposed within the upper portion and the lower portion, and a plunger is slidably disposed in at least the internal chamber of the body. The plunger has a distal end configured for delivering the bone material out of the lower portion of the body, wherein movement of the plunger in a first position toward the lower portion of the body delivers the bone material from the lower portion of the body to the surgical site. Methods of delivering the bone material are also provided.

Abstract: Protection devices are described herein. The protection devices include a body having a first end comprising a curved portion integral with the body for engaging a femoral head, the curved portion having a front face that is concave and terminates at an edge extending between a first side of the body and a second side of the body, and a second end integral with and spaced apart from the first end by a middle portion. The second end and the middle portion are generally planar. The front face of the curved portion has a radius of curvature that corresponds to a radius of curvature of an outer surface of the femoral head to guide the femoral head into an acetabular cup. Methods of protecting a femoral head are also described herein.

Abstract: Technologies for aligning an acetabular prosthetic component in a patient's surgically prepared acetabulum include a reference sensor module securable to the patient's bony anatomy, an inserter sensor module securable to an acetabular prosthetic component inserter, and a display module. Each sensor module generates sensor data indicative of the orientation of the sensor module and/or structures to which the sensor module is coupled. The display module receives the sensor data from the sensor modules, determines the orientation of the acetabular prosthetic component relative to the patient's bony anatomy, and displays indicia of the determined orientation on a display.

Abstract: The invention relates to a method for the removal of a bone insert, for example a bone insert for a shoulder prosthesis, comprising: forming a hole of predefined diameter inside a proximal bone portion from which said bone insert is to be removed; inserting inside said hole an operating end of an instrument provided with a cutting element, wherein said cutting element is moveable to project through a side opening in said operating end, transversely with respect to a longitudinal axis of the instrument; deep-cutting by the cutting element a distal base of said bone insert, wherein said instrument is pushed and is rotated through 360 degrees around its longitudinal axis; removing the instrument from said hole; inserting and fixing a pin element inside said hole; perimetrally milling the bone insert at a predefined second diameter, by centering a milling cutter on said pin element; removing the bone insert and the pin element attached thereto.