An device for treating a native valve includes a sealing element and an anchoring element. The sealing element is made from a braided mesh material. The sealing element is dimensioned to be deployed in an annulus of a native valve of a heart at a position between native valve leaflets to contact the native valve leaflets during ventricular systole to create a seal to prevent regurgitation of blood from the left ventricle to the left atrium. The sealing element is configured to both be radially expanded and radially reduced while at the position between the native valve leaflets. The anchoring element is adapted for deployment in the heart, the anchoring element coupled to the sealing element and configured to support the sealing element at the desired position between native valve leaflets.

A replacement heart valve prosthesis for transcatheter repair of a native valve comprises a frame having a distal end, a proximal end, and a length between the distal end and the proximal end, the frame further comprising an exterior surface and an interior surface defining a lumen, the frame expandable from an unexpanded state to an expanded state. The frame further comprises an expandable region near the distal end of the frame and a cusp region near the proximal end of the frame. The cusp region has a plurality of valve attachment features. A valve construct is mounted to the exterior surface of the frame and attached to the frame at least at the valve attachment features.

Delivery systems and methods for delivering a valve anchor and a valve prosthesis to a native valve annulus are provided. The anchor can be deployed near the native valve annulus with a tether attached thereto. A portion of the tether can be positioned inferior to the deployed anchor in an inverted configuration for advantageous positioning for adjusting the anchor position and/or deployment of the valve prosthesis. A positioning tool can be tracked over the tether and used to properly position the anchor. The positioning tool can be configured to transition to a stiffened state that includes one or more bends configured to allow efficient positioning of the deployed anchor and to provide room for deploying the valve prosthesis. Once the anchor is properly positioned, the valve prosthesis can be deployed within the native valve annulus and within the valve anchor.

A catheter device is described. The device is for implanting a leaflet anchor (10) into the heart as part of a procedure for implanting an artificial chordae line (14). The catheter device comprises: a leaflet anchor (10) for attachment to the leaflet (12) of the heart; and a leaflet anchor deployment mechanism (6), (30), (38) for deploying the leaflet anchor (10). The leaflet anchor deployment mechanism (6), (30), (38) allows for retraction and repositioning of the leaflet anchor (10) after deployment of the anchor (10) into the leaflet (12) via an ejector unit (36) having a grasping device (50) with a first configuration arranged to permit deployment of the leaflet anchor (10) into the leaflet (12) without disengagement of the leaflet anchor (10) from the ejector unit (34), and a second configuration in which the leaflet anchor (10) is reversibly released from the ejector unit (36). In the first configuration the grasping device (50) of the ejector unit (36) grasps a proximal end of the leaflet anchor (10), whilst a distal end of the leaflet anchor (10) is unimpeded by the grasping device (50) to enable it to be implanted in the leaflet (12). In the second configuration the grasping device (50) is disengaged from the leaflet anchor (10).

The invention provides an inflatable insertion device capable of being percutaneously introduced into a patient's body. The insertion device comprises an inflatable element having a distal end and a proximal end and which is operable between a collapsed condition and an inflated condition by introducing an inflating fluid therein. An elongate member extends internally of the inflatable element from its distal end. The internal member is capable of being withdrawn towards the proximal end of the inflatable element to result in the distal end of the element being withdrawn towards the proximal end internally of the element. The invention further provides a locating device comprising a catheter having a catheter tube fitted with one or more inflatable insertion devices at a distal end thereof.

A transcatheter valve prosthesis includes an expandable tubular stent, a prosthetic valve within the stent, and an anti-paravalvular leakage component coupled to and encircling the tubular stent. The anti-paravalvular leakage component includes a radially-compressible annular scaffold, which is a sinusoidal patterned ring of self-expanding material, and an impermeable membrane extending over the annular scaffold. The anti-paravalvular leakage component has an expanded configuration in which at least segments of the annular scaffold curve radially away from the tubular stent. Alternatively, the anti-paravalvular leakage component includes a plurality of self-expanding segments and an annular sealing element coupled to inner surfaces of the segments. The anti-paravalvular leakage component has an expanded configuration in which the segments curve radially away from the tubular stent and the annular sealing element is positioned between an outer surface of the tubular stent and inner surfaces of the segments. The segments may be orthogonal or oblique to the outer surface of the tubular stent.

Devices and methods for securing a tissue anchor in tissue of a patient, in particular to ensure proper deployment of a cardiac tissue anchor by regulating the force or pressure of a deployment tool against the tissue. One way to ensure proper deployment force is to visualize the distal end of the tissue anchoring catheter from outside the body using a display for an imaging sensor, where the distal end of the catheter changes configuration when it is pressed against the tissue. Another method involves automatically regulating the pressure applied to the tissue prior to deployment of the tissue anchor, which may also be used in conjunction with visualization. Several safety locks to prevent deployment of the tissue anchor prior to establishment of the proper pressure are disclosed, which again may be used with visualization and/or an automated pressure regulator.

The invention describes a stent of the aortic valve which is self-expandable and also repositionable and preferably made from nitinol. It consists of two parts: the upper part and the lower part. The lower part is a mesh (1) laid out so that it creates a kind of cylinder wall on the entire height of the element. Also other shape of the mesh is acceptable, for example partially conical, or partially resembling flattened side wall of the cylinder. However, the upper part of the stent consists of derived from the mesh (1) upwards and arranged at equal intervals three arms (2) the height of which is slightly larger than the height of the mesh (1), a bit less than the height of the mesh (1) or equal to its height. The stent arms (2) are shaped in such a way that they form together a kind of an oval chalice bowl, and their end, peripheral part is preferably straight and also inclined to the middle. Space between the arms (2) always ensures free access to patient's coronary arteries. At the end of each of the arms (2) is an upper tag (3) of the valve and each upper tag (3) has its corresponding lower tag (8) located at the bottom of the mesh (1) which is on the opposite side and below a given arm (2). The lower valve tag (8) enables precise implantation of the stent according to scheduled plan.

A method includes advancing apparatus including a core toward a patient's heart valve. The core tapers in a distal direction toward the smallest perimeter of the core. The apparatus includes a first ventricular arm, which is articulatable with respect to a first atrial arm at a first articulation site, and a second ventricular arm, which is articulatable with respect to a second atrial arm at a second articulation site. The articulation sites are adjacent to the smallest perimeter. The tapering of the core defines a minimum nonzero angle of the atrial arms with respect to a central longitudinal axis of the core. The method also includes clamping the first and second leaflets between the respective atrial arms and the respective ventricular arms. Other embodiments are also described.

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.