Abstract: A mitral valve prosthesis to be implanted in a heart, comprises an asymmetrical ring, the asymmetrical ring is dimensioned to mimic a native mitral annulus of a patient; an anterior flexible leaflet and a posterior flexible leaflet, said leaflets suspended from the asymmetrical ring and configured to substantially coapt with each other; and at least four sets of cords, each set of cords attached to the anterior or posterior leaflet on a first end and attached into a cap on a second end, the cap is configured to be attached onto papillary muscles of the heart on another end of the cap.

Abstract: The invention relates to a medical device, in particular a stent, having a radially self-expandable lattice structure (10) which is tubular at least in some sections and which is made of a single wire (11), which is interwoven with itself and which comprises a core material (11a) which is visible under X-ray and a superelastic jacket material (11b) and forms meshes (12) of the lattice structure (10). The invention is characterized in that a plurality of meshes (12) arranged directly adjacently in the circumferential direction of the lattice structure (10) form a mesh ring (13), and the lattice structure (10), in a fully self-expanded state, has an expansion diameter Dexp, the mesh ring (13) having a mesh number n, and the core material (11a) having a core diameter dKern, and the following being true for the core diameter dKern: dKern=f·(Dexp/n), with the following being true for a visibility factor f: 0.05?f?0.08.

Abstract: Provided is an implant configured for implantation in a bone segment, the implant including a first part that includes a hydrogel portion and a porous material portion, and a second part that includes an annular rim and a bottom that at least partially define a cavity configured to receive the porous material portion of the first part, and a barb extending from the bottom of the second part in a direction away from the cavity.

Abstract: Disclosed are valve replacement devices, systems, and methods. Valve replacement devices may comprise one- or two-piece systems comprising a receiver body (also called an adapter) and a valve assembly with replacement leaflets attached to and located within the receiver body. In two-piece systems, the valve assembly may be removable from the receiver body such that both can be delivered together or separately, and the receiver body may remain implanted while the valve assembly may be removed and replaced. Also described are devices, systems, and methods related to delivering, removing, and replacing a valve replacement. Such delivery methods may include transseptal insertion of a new minimum leaflet structure, and securement of the valve replacement using several securement type (e.g., supra-annular, sub-annular, radial, leaflet securement, etc.). Also described is a braided helical design that mimics the heart's natural movement, and a flange structure for assisting the functioning of the valve replacement.

Abstract: Described herein are prosthetic heart valves and methods for improving the functionality of native heart valves. An exemplary prosthetic heart valve may include one or more support structures, in which at least one support structure defines an elongate central passageway having a longitudinal. The prosthetic heart valve may include a plurality of leaflet elements attached to the at least one support structure and disposed within the elongate central passageway for control of blood flow through the elongate central passageway. The at least one support structure may be configured to biodynamically fix the prosthetic heart valve to native leaflets of a native heart valve of a heart.

Abstract: Apparatus and methods for an implant are provided. The implant may have a constrained configuration and a relaxed configuration. The implant may include a strut having an end that may be captured by a hub and may define a reference angle in the relaxed configuration. The implant may include a swivel body that may engage a shaft of a delivery cable and may be rotated through the reference angle. The apparatus may include a pusher catheter to push the implant. The delivery cable may engage the implant. The apparatus may include gauge handle that may include a force gauge to indicate the presence of a force acting on the implant. The apparatus may include a bushing that may be fixed to an end of a pusher catheter. The bushing may move along a delivery catheter lumen and may guide the implant to a keyed position at the bushing.

Abstract: Apparatus and methods for an implant are provided. The implant may have a constrained configuration and a relaxed configuration. The implant may include a strut having an end that may be captured by a hub and may define a reference angle in the relaxed configuration. The implant may include a swivel body that may engage a shaft of a delivery cable and may be rotated through the reference angle. The apparatus may include a pusher catheter to push the implant. The delivery cable may engage the implant. The apparatus may include gauge handle that may include a force gauge to indicate the presence of a force acting on the implant. The apparatus may include a bushing that may be fixed to an end of a pusher catheter. The bushing may move along a delivery catheter lumen and may guide the implant to a keyed position at the bushing.

Abstract: Apparatus and methods for an implant are provided. The implant may have a constrained configuration and a relaxed configuration. The implant may include a strut having an end that may be captured by a hub and may define a reference angle in the relaxed configuration. The implant may include a swivel body that may engage a shaft of a delivery cable and may be rotated through the reference angle. The apparatus may include a pusher catheter to push the implant. The delivery cable may engage the implant. The apparatus may include gauge handle that may include a force gauge to indicate the presence of a force acting on the implant. The apparatus may include a bushing that may be fixed to an end of a pusher catheter. The bushing may move along a delivery catheter lumen and may guide the implant to a keyed position at the bushing.

Abstract: Devices, systems, and methods for an implantable heart-valve adapter that enables compact and secure delivery into the heart and allows for convenient control of both the adapter during implantation as well as the expansion and retraction of the valve when implanted, removed, or replaced.

Abstract: A prosthetic heart valve includes a first frame shaped having metal segments and defines a lumen therethrough. A leaflet frame is coupled to and disposed within the lumen of the first frame. A second frame is configured to be placed against an upstream surface of the native valve. A plurality of prosthetic leaflets are coupled to the leaflet frame and facilitate upstream-to-downstream bloodflow through the prosthetic valve. Fabric couples the first and second frames together in the collapsed and expanded states of the prosthetic valve. In the expanded state of the prosthetic valve, the fabric separates a downstream end of the second frame and an upstream end of the metal segments of the first frame in a manner in which a gap is defined between the first and second frames, with no metallic structure being disposed within the gap. Other embodiments are also described.

Abstract: A transcatheter growth device for treating congenital illnesses in infantile and other pediatric heart disease patients and methods for making and using the same. The growth device includes an elongated device frame with alternating annular growth cell members and spacing members that axially span proximal and distal end regions of the device frame. The growth cell members and spacing members define a radial periphery for the growth device. Each growth cell member can comprise a scaffolded growth cell member with first and second annular strut arrangements coupled via a growth cell junction to provide device frame flexibility. A retention member for engaging a selected lumen within a patient and a covering member for sealing the growth device, when deployed, are disposed at the device periphery. The growth device advantageously can be deployed for treating heart disease alone or in combination with one or more additional growth devices.

Abstract: The present disclosure relates generally to the field of medical devices for delivering artificial chordae tendineae in a patient. A system for adjusting tension in an artificial chordae tendineae includes an artificial chordae tendineae coupleable between a clip and an anchor. The clip is engageable with a leaflet of a heart valve while the anchor is engageable with a papillary muscle or heart wall. The anchor includes a body portion, and a locking portion coupleable with the artificial chordae tendineae and configured to allow movement of the artificial chordae tendineae in a first direction while preventing movement of the artificial chordae tendineae in a second direction opposite the first direction. An actuator is coupled to the locking portion for selectively releasing the locking portion to enable selective movement of the artificial chordae tendineae in the second direction.

Abstract: A method is described, for use with a native valve of a heart of a subject, the valve being disposed between an atrium and a ventricle of the heart. A first radiopaque marker and a second radiopaque marker are percutaneously advanced to the heart. The first radiopaque marker is placed against a tissue site in the ventricle. The second radiopaque marker is placed against a component of the valve. A distance is fluoroscopically measured between the first radiopaque marker at the tissue site, and the second radiopaque marker at the component. At least one of the radiopaque markers is then withdrawn from the heart. Other embodiments are also described.

Abstract: Medical devices and method for making and using the same are disclosed. An example medical device may include implantable medical device for use along the biliary and/or pancreatic tract. The implantable medical device may include a tubular member having a first end configured to be disposed within the duodenum of a patient and a second end configured to be disposed adjacent to a pancreatic duct and/or bile duct. The tubular member may have a body including one or more wire filaments that are woven together. The tubular member may also have an outer surface with a longitudinal channel formed therein.

Abstract: A loading device for crimping a prosthetic heart valve without an internal support member includes a cone having a cone body with a tapering diameter and defining a lumen therethrough and a cone base extending radially from the cone body. The cone base may couple to a funnel also having a tapering diameter and defining a lumen therethrough. The cone may be coupled to the funnel such that the lumen of the cone is aligned with the lumen of the funnel along a longitudinal axis of the loading device. The cone body may define a plurality of slots configured to receive the tines extending from the prosthetic heart valve as the valve is pulled through the loading device and compressed from an expanded state to a collapsed state by the tapering diameter of the cone and the funnel to be disposed inside a delivery device.

Abstract: A transcatheter valve implant assembly has a ventricular assist device, a prosthetic valve, a stent frame structure, and a docking station, and is implanted at an aortic or a pulmonary valve. During implantation, the native valve leaflets of the respective valve at the implantation site are engaged with the prosthetic valve and/or the stent frame structure while the stent frame structure is connected to the docking station with the prosthetic valve adjacent to the proximal end of the stent frame structure. The ventricular assist device is inserted into the interior the stent frame structure with an inlet of ventricular assist device positioned in the respective ventricle associated with the implantation site and the outlet of the ventricular assist device positioned to discharge into the respective blood vessel associated with the implantation site. The ventricular assist device is releasably connected with the stent frame structure and the docking station.

Abstract: Medical delivery system for accessing a tricuspid valve via an inferior vena cava, including an outer guide catheter, an inner guide catheter and an interventional catheter. The first deflection portion of the outer guide catheter is steerable to define a first outer-guide-catheter curve and the second deflection portion of the outer guide catheter is steerable to define a second outer-guide-catheter curve and the first deflection portion of the inner guide catheter is steerable to define a first inner-guide-catheter curve.

Abstract: The present disclosure includes, in one embodiment, a tensioner instrument having a body having a channel and a plurality of arms projecting outward from the body, each arm including a cleat having a slot adapted to receive a suture; a base member positioned within the channel of the body; an actuating mechanism having a first coupling member adapted to engage a second coupling member on the body to removeably couple the actuating mechanism to the body; and a universal joint adapted to allow for relative movement between the base member and the body such that, when each suture is positioned within each cleat and the actuating mechanism is actuated, the tensioner applies uniform tension to each suture positioned in each cleat.

Abstract: A 3-D honeycomb textile can include a textured yarn. The textile can exhibit a heat-shrinkage rate from about 10% to about 60%. The textile can be configured to reversibly change its dimensions under application of stress. Prosthetic valves can have the disclosed textiles as a sealing member. Additionally, prosthetic valves can the disclosed textiles as cushion materials. In addition, methods of making the disclosed textiles and prosthetic valves are described.

Abstract: The present disclosure relates to a three-dimensionally (3D) printed tissue engineering scaffold for tissue regeneration and a method for manufacturing the 3D printed tissue engineering scaffold. The 3D printed tissue engineering scaffold may be fabricated at least in part from a composite material having an insoluble component and soluble component. The three-dimensional tissue scaffolds of the disclosure may be fabricated via a rapid prototyping machine. In some instances, the three-dimensional shape of the fabricated tissue engineering scaffold may correspond to a three-dimensional shape of a tissue defect of a patient.