Abstract: A tricuspid regurgitation treatment tool to be inserted into the pulmonary artery is proposed. The tricuspid regurgitation treatment tool to be inserted into the pulmonary artery is used to verify whether the right ventricular dysfunction may occur when treating the tricuspid regurgitation by surgeries or other permanent treatments. A test insertion of the tricuspid regurgitation treatment tool to be inserted into the pulmonary artery is made to pass obliquely through the tricuspid valve of a patient, and after a certain time has elapsed, the tool is removed. The tricuspid regurgitation treatment tool to be inserted into the pulmonary artery includes: a blocking part blocking the tricuspid valve; and an insertion tube provided with a guidewire-guiding lumen formed therein to be movable along the guidewire.

Abstract: Medical devices and methods for making and using medical devices are disclosed. An example medical device may include a guide extension catheter. The guide extension catheter may include a proximal member having a proximal end, a distal end, and a proximal diameter. The guide extension catheter may additionally include a collar member attached to the distal end of the proximal member, the collar member comprising a base portion and one or more ribs connected to the base portion and extending distally away from the base portion. In still some additional embodiments, the guide extension catheter may further include a distal sheath member attached to the collar member, the distal sheath member having a distal diameter larger than the proximal diameter.

Abstract: Some embodiments are directed to methods for serially expanding an artificial heart valve within a pediatric patient. For example, the artificial heart valve can be implanted into the pediatric patient during a first procedure, and then expanded during a second procedure to accommodate for the pediatric patient's growth. Some embodiments include introducing an expander into the implanted valve when the frame is expanded to a first working diameter, and then actuating the expander to expand the frame to a second working diameter greater than the first working diameter, to accommodate for the pediatric patient's growth.

Abstract: The present disclosure relates generally to the field of medical devices. In particular, the present disclosure relates to devices and methods for controlled delivery of a stent, such as a self-expanding stent, and more particularly for controlling the full deployment of a stent in incremental steps from a sheath and for controlling the reconstrainment of a stent in incremental steps within a sheath.

Abstract: A sutureless implant for replacing damaged natural chordae tendineae of a human or possibly animal heart, the implant including a distal implant part, a proximal implant part, and an artificial chord. The distal implant part is configured to fit in a lumen of an implant delivery device and includes a self-spreading portion spreading radially outside when the distal implant part is released from the lumen, the self-spreading portion being capable of anchoring the distal implant part in human muscle tissue. The proximal implant part is configured to fit in the lumen of the implant delivery device and comprises a self-spreading portion spreading radially outside when the proximal implant part is released from the lumen, the self-spreading portion being capable of bearing on a tissue portion of leaflet tissue. The distal implant part and the proximal implant part are connected by the chord.

Abstract: The present disclosure provides methods of improving cardiac function, including transcutaneously inserting at least one catheter into a heart, delivering a band to a ventricle of the heart via the at least one catheter, guiding the band through a plurality of spaces among a trabeculae in the ventricle, tightening the band in a single loop, locking the band in a loop, and removing the at least one catheter from the heart.

Abstract: An assembly-type device for the treatment of tricuspid regurgitation is proposed. The assembly-type device includes: a fixing member for the pulmonary artery, the fixing member installed in the pulmonary artery; a connecting tube provided with a connecting tube lumen formed therein to be movable along a connecting wire; an assembly part provided with a first assembly coupled to a lower end of the fixing member for the pulmonary artery and a second assembly coupled to an upper end of the connecting tube, wherein the fixing member for the pulmonary artery and the connecting tube are assembled together; a fixing member for inferior vena cava, the fixing member coupled to a lower end of the connecting tube and installed in the inferior vena cava; and a blocking part coupled to one side of the connecting tube and obliquely passing through a tricuspid valve to block an orifice of the tricuspid valve.

Abstract: In some examples, a delivery device includes a handle that includes a control member, an elongate body, a plurality of arms extending from a distal portion of the elongate body to a distal collar configured to releasably couple to an annuloplasty device. The plurality of arms is operatively coupled to the control member and configured to position the annuloplasty device at a target site in a patient. The delivery device further comprises a plurality of anchors configured to secure the annuloplasty device to tissue at the target site, each respective anchor of the plurality of anchors deployable from a respective arm of the plurality of arms.

Abstract: A minimally-invasive annuloplasty ring for implant at a mitral annulus. The annuloplasty ring has an inner core member with a C-shaped plan view that generally defines an oval with a major axis and a minor axis, and is symmetric about the minor axis. A posterior portion of the core member bisected by the minor axis has a thicker radial dimension than a pair of free end regions terminating on an anterior side of the core member. The radial thickness smoothly transitions between the posterior portion and the end regions. The inner core member may be covered with a fabric, and is a superelastic metal so that it can be straightened out and delivered through an access tube. The curvatures and thicknesses around the core member are selected so that the strain experienced when straightened does not exceed 7-8%.

Abstract: Methods, systems, and coaptation measurement devices as described herein include an elongate sensor body at the end of a proximal connecting member, and a plurality of sensors in an array across a face of the sensor body, wherein each sensor of the plurality of sensors is configured to detect if a portion of a heart valve is in contact with the sensor.

Abstract: A device for improving the function of a heart valve comprises a first loop-shaped support, which is configured to abut a first side of the heart valve, and a first flange unit being connected to said first loop-shaped support. The flange unit is configured to be arranged against said annulus when said first loop-shaped support is abutting said heart valve.

Abstract: Described is a prosthetic valve, comprising: an expandable stent including an inner lumen and having a first and a second end; and a spring attached to the first end of the expandable stent; wherein the expandable stent and the spring can expand radially to a desired diametric configuration in order to anchor the prosthetic valve at an implantation position in a body lumen. Related systems and methods.

Abstract: A valve repair device for repairing a native valve of a patient includes a pair of paddles and a pair of gripping members. The pair of paddles are movable between an open position and a closed position. Each paddle comprises a metal loop that is moveable from a compressed condition where each metal loop has a first width to an expanded condition where each loop has a second width that is greater than the first width. The pair of gripping members are configured to attach to the native valve of the patient.

Abstract: Prosthetic heart valves and methods of implantation thereof are disclosed herein. In embodiments, a prosthetic heart valve includes a self-expandable frame configured to support of valve member and comprising a plurality of interconnected strut members forming a mesh structure. An inflow end and outflow end portions of the mesh structure respectively define an inflow terminal end and an outflow terminal end of the frame. A portion of the frame tapers inwardly from the inflow terminal end to form a reduced diameter section. In implementations, the frame increases in diameter from the reduced diameter section to an intermediate section. In implementations, the valve member is secured to the frame at the inflow end portion. In implementations, the frame further comprises a plurality of retaining arms that extend from the outflow terminal end and are configured to engage with a valve retaining mechanism of a delivery apparatus.

Abstract: A delivery device includes an inner shaft, an outer sheath, a nosecone, and a tether component. The outer sheath is slidably disposed over the inner shaft. The nosecone is removably coupled to the inner shaft. The nosecone includes a delivery configuration for delivery to a treatment site, a radially compressed configuration in which a portion of the nosecone is configured to traverse through a heart wall, and a radially expanded configuration in which an outer surface of the nosecone contacts an outer surface of the heart wall. The tether component includes a first end coupled to the nosecone. The nosecone is configured to plug a piercing in the heart wall when in the radially expanded configuration.

Abstract: A delivery device for a stented heart valve includes a handle, an elongate shaft extending from a distal end of the handle, and a conical housing having a proximal end coupled to the elongate shaft and an open distal end, the conical housing having a conical lumen therein with a first internal diameter adjacent to the proximal end of the conical housing and a larger second internal diameter adjacent to the open distal end of the conical housing.

Abstract: Prosthetic valves and methods of use of prosthetic valves may be provided. In one implementation, a prosthetic valve may include an annular outer frame, an inner frame, and a plurality of ventricular anchoring legs extending from the outer frame. The outer frame may be formed at least partially of struts intersecting at junctions. At least one ventricular anchoring leg may include a first curved leg portion on a first surface of the leg, and a second curved leg portion on a second, opposite surface of the leg. The outer frame may also include a strut extending between a downstream end of the outer frame and the junction from which the at least one ventricular anchoring leg extends.

Abstract: A loading assembly for crimping and loading a prosthetic heart valve into a delivery device includes a loading base, a base funnel, and a compression member. The loading base has a support and a body extending from the support with a recess defined within the body. The recess is configured to receive a substantial portion of the annulus section of the heart valve in an at least partially collapsed condition. The base funnel is configured to be coupled to the loading base and to at least partially collapse the annulus section of the heart valve as it is inserted into the recess in the loading base. The compression member is configured to be coupled to the loading base with the heart valve inserted in the recess for further collapsing the heart valve and loading it into the delivery device.

Abstract: The invention relates in general to the field of heart surgery. In the surgical field, instruments are used in order to examine the interior of living organisms and/or to use for operative interventions. These also include implants for the production of the functionality of a heart. The invention relates to such an implantable device and a method for eliminating regurgitation in the area of the heart. The implantable device is an annuloplasty ring with a large number of tissue anchors. An unfolded annuloplasty ring is positioned in the cavity of a body element in order to constrict a bodily opening. Using the minimally-invasive technique, each tissue anchor of the annuloplasty ring is intravascularly inserted in advance into a precise position on the edge of the mitral valve annulus.

Abstract: Apparatus and methods are described herein for use in the delivery and deployment of a prosthetic mitral valve into a heart. In some embodiments, an apparatus includes a catheter assembly, a valve holding tube and a handle assembly. The valve holding tube is releasably couplable to a proximal end portion of the catheter assembly and to a distal end portion of the handle assembly. The handle assembly includes a housing and a delivery rod. The delivery rod is configured to be actuated to move distally relative to the housing to move a prosthetic heart valve disposed within the valve holding tube out of the valve holding tube and distally within a lumen of the elongate sheath of the catheter assembly. The catheter assembly is configured to be actuated to move proximally relative to the housing such that the prosthetic valve is disposed outside of the lumen of the elongate sheath.

Abstract: A prosthetic cardiac valve assembly and method of implanting the same is disclosed. In certain disclosed embodiments, the prosthetic valve assembly is an annuloplasty ring with an attached artificial valve. The prosthetic valve assembly can be secured to native heart tissue by suturing or other suitable method of the annuloplasty ring to the native heart tissue. The prosthetic valve leaflets of the prosthetic valve can also be anchored to the native heart tissue to prevent prolapse. In certain embodiments, the prosthetic valve leaflets are anchored to the native papillary muscles. In still other embodiments, the prosthetic valve assembly contains exactly the number of prosthetic valve leaflets as are in the native valve that the prosthetic valve assembly is configured to replace. With the prosthetic valve assembly properly positioned, it will replace the function of the native valve.

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: The present disclosure relates to delivery devices and interventional devices configured to enable monitoring of pressure and other hemodynamic properties before, during, and/or after a cardiac procedure. A guide catheter includes a routing lumen or a routing groove for routing a sensor wire to a desired location during a cardiac procedure. A guide catheter includes one or more pressure sensors positioned to provide desired pressure measurements when the guide catheter is deploying an interventional device. An interventional device may also include one or more associated sensors for providing hemodynamic information before, during, and/or after deployment.

Abstract: A prosthetic heart valve is provided with a cuff having features which promote sealing with the native tissues even where the native tissues are irregular. The cuff may include a portion adapted to bear on the LVOT when the valve is implanted in a native aortic valve. The valve may include elements for biasing the cuff outwardly with respect to the stent body when the stent body is in an expanded condition. The cuff may have portions of different thickness distributed around the circumference of the valve in a pattern matching the shape of the opening defined by the native tissue. All or part of the cuff may be movable relative to the stent during implantation.

Abstract: Methods of delivering a prosthetic aortic heart valve are disclosed.

Abstract: A ringless web is configured to repair heart valve function in patients suffering from degenerative mitral valve regurgitation (DMR) or functional mitral valve regurgitation (FMR). In accordance with various embodiments, a ringless web can be anchored at one or more locations below the valve plane in the ventricle, such as at a papillary muscle, and one or more locations above the valve plane, such as in the valve annulus. A tensioning mechanism connecting the ringless web to one or more of the anchors can be used to adjust a tension of the web such that web restrains the leaflet to prevent prolapse by restricting leaflet motion to the coaptation zone and/or promotes natural coaptation of the valve leaflets.

Abstract: This invention relates to the design and function of a compressible valve replacement prosthesis, collared or uncollared, which can be deployed into a beating heart without extracorporeal circulation using a transcatheter delivery system. The design as discussed focuses on the deployment of a device via a minimally invasive fashion and by way of example considers a minimally invasive surgical procedure preferably utilizing the intercostal or subxyphoid space for valve introduction. In order to accomplish this, the valve is formed in such a manner that it can be compressed to fit within a delivery system and secondarily ejected from the delivery system into the annulus of a target valve such as a mitral valve or tricuspid valve.

Abstract: A surgical access device includes a cannula body and an anchor. The cannula body includes a housing, and an elongated portion extending distally from the housing. The elongated portion defines a longitudinal axis and defines a channel extending therethrough. The anchor is disposed in mechanical cooperation with the elongated portion of the cannula body and is longitudinally translatable relative to the elongated portion. The anchor defines an aperture and includes a ratchet mechanism configured to selectively lock a size of the aperture.

Abstract: Devices, systems and methods are provided for stabilizing and grasping tissues such as valve leaflets, assessing the grasp of these tissues, approximating and fixating the tissues, and assessing the fixation of the tissues to treat cardiac valve regurgitation, particularly mitral valve regurgitation.

Abstract: Methods for generating aortic heart valve leaflets are disclosed wherein the aortic sinus surfaces (the inner surfaces of the sinuses of Valsalva) are used as a template to generate geometric representations of replacement aortic heart valve leaflets. As such, sinus-matched replacement leaflets can be sized and shaped according to the patient-specific geometry of the aortic root. Patient-specific aortic valve assemblies based on aortic root and sinus geometry are also described. Methods for estimating the coaptation area of a sinus-matched valve and assessing whether the valve is functionally competent for implantation are described.

Abstract: The invention relates to a device for use in the transcatheter treatment of mitral valve regurgitation, specifically a coaptation assistance element for implantation across the valve; a system including the coaptation assistance element and anchors for implantation; a system including the coaptation assistance element and delivery catheter; and a method for transcatheter implantation of a coaptation element across a heart valve.

Abstract: Embodiments hereof relate to methods of delivering a valve prosthesis to an annulus of a native valve of a heart, the native valve having chordae tendineae. A chordae management catheter is positioned within a ventricle of the heart, the chordae management catheter having a displacement component at a distal end thereof. The displacement component has an annular shape and defines a central lumen therethrough. The displacement component is radially expanded to push chordae tendineae within the ventricle radially outward. A valve delivery system is introduced into the ventricle of the heart via a ventricular wall of the heart. The valve delivery system has the valve prosthesis at a distal portion thereof. The valve delivery system is advanced through the central lumen of the radially expanded displacement component towards the annulus of the native valve of the heart. The valve prosthesis is deployed into apposition with the annulus of the native valve.

Abstract: Disclosed herein are designs for improved inflatable structures for use during minimally invasive cardiovascular procedures. These inflatable structures facilitate the perfusion of blood through an anatomical structure, such as a heart valve, during the cardiovascular procedure. The inflatable structures are formed of a plurality of balloons arranged radially around a central location. The plurality of balloons form a lumen through which blood flows. Each balloon of the plurality is shaped or configured to stabilize the adjacent balloons, limiting their movement relative to each other. For example, some embodiments can feature balloons with a keystone shape that limits movement of the balloons inward toward the lumen. Some implementations can also include a support coil running through the lumen. The support coil holds enables the lumen to be open to perfusion even in the early stages of balloon inflation.

Abstract: A method and device for anchoring a prosthetic heart valve or annuloplasty ring to a valve annulus in a heart and a method of implanting same is disclosed. The device can include a prosthetic valve or annuloplasty ring with one or more anchors configured to be threaded or otherwise passed underneath a native leaflet and/or subvalvular tissue to secure the device at the native annulus.

Abstract: A system for delivering a collapsible and re-expandable prosthetic heart valve into a patient includes a valve support structure around which the valve is disposed in a collapsed condition. A sheath structure surrounds the collapsed valve, but can be moved relative to the valve to uncover it for expansion at the desired implant site in the patient. The sheath structure may be variously mounted and moved to deploy the valve in various ways. For example, the sheath structure may include multiple parts, each of which can be moved separately to separately deploy various parts of the valve. The apparatus may have other aspects, such as the ability to reverse deployment of the valve, the ability to pass other instrumentation through the valve delivery apparatus, the ability to be smoothly withdrawn from the patient after deployment of the valve, etc.

Abstract: A valve prosthesis, implantation device, and methods for use are provided. The devices described herein may be used for transcatheter delivery of an aortic valve prosthesis or transapical delivery of a mitral valve prosthesis. The implantation device can utilize movable claspers for both positioning and anchoring the valve prosthesis, reducing the extent of imaging needed during the implantation procedure.

Abstract: The present invention relates to a device (3) intended to be attached to or interconnected with a medical implant (1), and intended to be attached to or interconnected with a catheter (5), the catheter (5) being intended for implanting the implant (1). The invention further relates to a catheter (5) suited for receiving at least one such device (3) and to a method.

Abstract: A percutaneous device including a temporary valve attached to a sheath, the sheath having an inverting section for delivery and removal thereof from a blood vessel. The sheath is inverted for delivery, housing the valve between inverted layers thereof. To deploy said valve, the sheath is everted to position the temporary valve on an outer surface thereof. The temporary valve and sheath are reversibly movable between inverted and deployed configurations. Upon eversion, the temporary valve assumes a radially expanded canopy shape having an outer diameter selected to contact the vessel wall and allow blood flow in only one direction. The temporary valve may be removed by releasing one end of the valve from the sheath, flattening the temporary valve along the longitudinal axis of the sheath. Also provided is a temporary valve system comprising a dilator for inverting and everting the sheath, said dilator being removably connected to the sheath.

Abstract: Methods of delivering a prosthetic aortic heart valve are disclosed.

Abstract: A system for delivering an implantable medical device includes an outer sheath drive assembly and an actuation shaft drive assembly. The outer sheath drive assembly is configured to cause an outer sheath to translate relative to a handle, and includes an outer sheath drive motor. The actuation shaft drive assembly is configured to cause an actuation shaft to translate relative to the handle, and includes an actuation shaft drive motor. The outer sheath drive motor and/or the actuation shaft drive motor may be removed from the system, and the outer sheath drive assembly and/or the actuation shaft drive assembly may instead be manually driven.

Abstract: A prosthetic heart valve may include a collapsible and expandable stent extending in a flow direction between a proximal end and a distal end, a cuff attached to an annulus section of the stent and having an outer surface facing in a radial direction orthogonal to the flow direction, a plurality of prosthetic valve leaflets attached to the cuff, and a sealing structure attached to the annulus section of the stent at an inner edge of the sealing structure. The flow direction may be defined from the proximal end toward the distal end. The sealing structure may have an outer edge remote from the inner edge. The sealing structure may have a collapsed condition with the outer edge disposed adjacent the outer surface of the cuff and an expanded condition with the outer edge spaced apart from the outer surface of the cuff.

Abstract: A prosthetic cardiac valve comprises an anchor having an atrial skirt, an annular region, and a ventricular skirt. The prosthetic valve also has a plurality of prosthetic valve leaflets each having a first end and a free end. The first end is coupled with the anchor and the free end is opposite the first end. The prosthetic cardiac valve has an open configuration in which the free ends of the prosthetic valve leaflets are disposed away from one another to allow antegrade blood flow therepast, and a closed configuration in which the free ends of the prosthetic valve leaflets engage one another and substantially prevent retrograde blood flow therepast. The anchor has a collapsed configuration for delivery to the heart and an expanded configuration for anchoring the prosthetic cardiac valve to a patient's heart.

Abstract: Methods, systems and devices for applying energy to tissue, and more particularly relates to a system for ablating or modifying structures in a body with systems and methods that generate a flow of vapor at a controlled flow rate for applying energy to the body structure.

Abstract: A delivery device for percutaneously delivering a stented prosthetic heart valve includes a capsule assembly, a handle, and an outer stability shaft. The capsule assembly includes a capsule and a proximal shaft coupled to the capsule. The capsule includes an expanded configuration wherein the capsule has a first outer diameter, and a collapsed configuration wherein the capsule has a second outer diameter smaller than the first outer diameter. The outer stability shaft defines a lumen and is coupled to the handle and configured to receive the proximal shaft within the lumen of the outer stability shaft. The outer stability shaft has an inner diameter, wherein the first outer diameter of the capsule is greater than the inner diameter of the outer stability shaft and the second outer diameter of the capsule is smaller than the inner diameter of the outer stability shaft.

Abstract: Transcatheter guidewire delivery systems, catheter assemblies and associated methods for percutaneous guidewire delivery across heart valves are disclosed herein. A catheter assembly configured in accordance herewith includes an elongated tubular component and an alignment assembly at a distal portion of the tubular component and which is adapted to be located at a target location adjacent a heart valve of a patient. In one embodiment, the alignment assembly deploys to a shape set loop configuration with a side port in an open configuration positioned to allow advancement of a guidewire to exit the catheter in an aligned path with a leaflet coaptation region of the heart valve. In another embodiment, the alignment assembly has a plurality of spaced apart side ports that a guidewire may advance therethrough and toward the heart valve. In some embodiments, a wire guide is used to align the guidewire with a selected side port.

Abstract: The present application relates to a cardiac valve prosthesis and a stent thereof. The stent comprises an inflow channel, an outflow channel, and a transitional area between the inflow channel and the outflow channel along an axial direction; the outflow channel comprises a cyclic structure and at least two convex structures extending along the axial direction; the at least two convex structures are respectively connected to the end of the cyclic structure distant from the transitional area; a restricted vacant area is formed between adjacent convex structures. The cardiac valve prosthesis and the stent thereof are not only suitable for multiple types of valve replacement, risks of injuries and operation costs are reduced for patients, and the influence of the stent to cardiac functions is minimized.

Abstract: A valve stent and a valve prosthesis. The valve stent is in the shape of a mesh tube, and has a compressed state and an expanded state. The valve stent includes an inflow tract structure, a transition tract structure, an outflow tract structure, and a barb structure. The transition tract structure has a fifth end portion, a sixth end portion, and a first middle section. In the expanded state, the diameters of the radial sections of the fifth end portion and the sixth end portion are greater than the diameter of the radial section of the first middle section of the transition tract structure. The outflow tract structure has a seventh end portion and an eighth end portion. The seventh end portion of the outflow tract structure is fixedly connected to the sixth end portion of the transition tract structure, and the eighth end portion is a free end.

Abstract: A device for loading a prosthesis onto a delivery system includes a first housing having a central bore, One or more actuators on the first housing may be actuated radially inward to selectively compress a discrete portion of the prosthesis disposed in the central bore.

Abstract: A method of preventing paravalvular leakage includes concurrent delivery of a heart valve prosthesis and an annular sealing component. During delivery, the sealing component is moved from a first position to a second position of the heart valve prosthesis which is longitudinally spaced apart from the first position of the heart valve prosthesis. The sealing component is secured around the heart valve prosthesis at the second position by a contoured outer surface of the heart valve prosthesis. The sealing component may be a flexible ring or may be a cylindrical flexible sleeve having a plurality of ribs longitudinally extending over the cylindrical sleeve. The ribs operate to deploy the sealing component such that at least a portion of the cylindrical sleeve buckles outwardly away from the outer surface of the heart valve prosthesis.

Abstract: An implantable prosthetic spacer device can include an inflatable spacer having a plurality of inflatable members and a frame, the frame comprising one or more anchors and one or more clasps. The inflatable spacer can be configured to be disposed between native leaflets of a heart. The implantable prosthetic spacer can be disposed in a symmetrical or an asymmetrical configuration. The inflatable spacers can be inflatable between an uninflated and an inflated configuration.