Edwards Lifesciences Patente

In one representative embodiment, a prosthetic valve assembly for replacing a native heart valve comprises a radially expandable and compressible support structure, the support structure comprising an annular frame having a lumen extending from an inflow end to an outflow end, the support structure further comprising an annular sealing member extending radially inwardly into the lumen of the frame and having an inner peripheral portion defining an orifice, and a radially expandable and compressible valve component, the valve component comprising an annular frame and a valve structure supported inside of the frame for permitting the flow blood through the valve component in one direction and blocking the flow of blood in the opposite direction, wherein the valve component is configured to expand within the orifice of the sealing member and engage the inner peripheral portion of the sealing member when radially expanded.

Devices, systems and methods are described herein to provide improved treatment of a tricuspid valve. Such treatment may include tricuspid valve replacement, which may include providing a prosthetic tricuspid valve within the tricuspid valve annulus. Delivery systems for delivering the prosthetic tricuspid valve to the tricuspid valve annulus are disclosed herein. Treatment may also include repair of the tricuspid valve.

A belt for an implantable prosthetic device can include an annular body including a plurality of alternating peaks and valleys and a plurality of frangible members extending between at least one of adjacent peaks and adjacent valleys. The annular body can be radially expandable from a radially compressed configuration to a first diameter upon application of a radially outwardly directed force via an expandable implantable prosthetic device. A first frangible member of the plurality of frangible members can be configured to break when the radially outwardly directed force exceeds a first predetermined threshold to allow radial expansion of the annular body to a second diameter.

An assembly includes a holder device and a non-self-expandable prosthetic heart valve. The prosthetic heart valve can be radially compressed from an expanded configuration to a compressed configuration. The holder device is configured to hold the prosthetic heart valve in the expanded configuration and to allow the prosthetic heart valve to be inserted in a crimping device so that the prosthetic heart valve can be crimped onto a valve mounting portion of a delivery apparatus.

Disclosed herein are implantable prosthetic valves having outer sealing member comprising a bulge in the expanded configuration. The bulge can be configured to provide sealing against native anatomy when the valve is implanted and to assist in minimizing a paravalvular leakage. In addition, disclosed herein are methods of making the prosthetic valves.

A leaflet clip has an elongated member including a proximal end portion and a distal end portion, and first and second clipping arms movable between an open position and a closed position. The clipping arms include respective proximal end portions coupled to the proximal end portion of the elongated member, and respective distal end portions extending distally and radially outward relative to the elongated member. The leaflet clip further includes a tubular member coaxially disposed about the elongated member. Axial motion of the tubular member with respect to the elongated member or axial motion of the elongated member with respect to the tubular member causes corresponding movement of the clipping arms between the open and closed positions.

A medical implant delivery system can comprise a puncture needle, a medical implant delivery catheter and the puncture needle being configured to be slidably advanced through a puncture needle lumen of the medical implant delivery catheter, a medical implant device positioned on the medical implant delivery catheter, and an outer delivery catheter comprising a medical implant delivery lumen, the medical implant delivery catheter being configured to slidably extend through the medical implant delivery lumen. A medical implant delivery system can comprise a puncture needle, a medical implant delivery catheter and the puncture needle being configured to slidably extend through the puncture needle lumen of the medical implant delivery catheter, a medical implant device positioned on the medical implant delivery catheter, an elongate housing adjacent to the medical implant delivery catheter, and an outer sheath around a portion of the medical implant delivery catheter and the elongate housing.

Examples of an expandable sheath can be used in conjunction with a catheter assembly to introduce a prosthetic device, such as a heart valve, into a patient. Such examples can minimize trauma to the vessel by allowing for temporary expansion of a portion of the introducer sheath to accommodate the delivery apparatus, followed by a return to the original diameter once the prosthetic device passes through. Some examples can include a sheath with inner and outer layers, where a folded portion of the inner layer extends through a slit in the outer layer and a portion of the outer layer overlaps the folded portion of the inner layer. Some examples include an elastic outer cover positioned outside the outer layer. Examples of the present expandable sheath can avoid the need for multiple insertions for the dilation of the vessel, thus offering advantages over prior art introducer sheaths.

A prosthetic heart valve has a plurality of valve leaflets that control directional flow of blood through a heart and a stent structure having a plurality of commissure posts supporting the valve leaflets. The stent structure has a covering over the plurality of commissure posts and has a sewing ring at an inflow end of the stent structure. Each of the plurality of commissure posts has a tip and a suture loop is attached to the covering at a location adjacent to or on the tip of the commissure post. Each suture loop provides a passage for a suture to pass through between the covering and the suture loop.

Certain examples of the disclosure concern a prosthetic device. The prosthetic device can include a radially compressible and expandable frame and a screw actuator coupled to the frame and configured to be rotated to radially expand the frame from a radially compressed state to a radially expanded state. The frame can include two or more pairs of first markers and second markers. The pairs of first and second markers can be circumferentially spaced apart from each other. The first and second markers of each pair can be axially aligned and axially movable relative to one another as the frame radially expands. Positions of the first and second markers can be configured so that a difference in axial distances between respective pairs of the first markers and second markers can indicate a degree of evenness of the frame's radial expansion.

A docking station frame for a medical device includes a plurality of strut portions extending from a proximal end to a distal end and forming a plurality of cells.

Embodiments of a prosthetic heart valve comprise an annular main body, an atrial cap extending radially outwardly from the atrial end of the main body, and a plurality of ventricular anchors extending outwardly from the ventricular end of the main body. Each ventricular anchor can have a proximal end portion connected to the ventricular end, an intermediate portion extending away from the atrial end and then back toward the atrial so as to define a first bend, and a free distal end portion that extends from the intermediate portion. The distal end portion can comprise a first section, a second section, and a second bend between the first and second sections, the first section extending from the intermediate portion in a direction toward the atrial end and radially away from the main body.

An implantable prosthetic device includes a coaption portion, paddles, and clasps. The paddles are moveable from a closed position to an open position. The clasps are also moveable from an open position to a closed position. The implantable prosthetic device can be used to repair a naitive valve, such as a native mitral valve.

An introducer sheath can be used to safely introduce a delivery apparatus into a patient's vasculature (e.g., via the femoral artery). It is advantageous to visualize the placement of an introducer sheath within the vasculature using an imaging system. The sheaths disclosed herein include radiopaque features that assist with imaging without sacrificing the low profile, expandability, and other advantageous aspects of the introducer sheath.

Systems and methods for cardiac monitoring and treatment using left atrial pressure are described herein. In many aspects, a pressure sensor implantable into the left atria, of a patient's heart records a pressure signal. The left atrial pressure can be used to calculate an A/V ratio, which has clinical significance, and in turn can be used to guide treatment and/or as part of an open or closed loop automated treatment system.

Various systems, devices, and methods are described herein pertaining to expandable sheaths. Sheath aspects are described that include a flexible sheath tip that is expandable and bendable. In some aspects, the sheath includes a radially expandible proximal end and a radially expandable distal end. In some aspects, the sheath tip includes a plurality of layers that expand to accept a medical device traveling axially and bi-directionally therethrough with minimal deformation of the sheath tip.

An implantable prosthetic valve comprises an annular frame that is radially expandable from a radially compressed state to a radially expanded state. The frame has an inflow end, an outflow end, and a longitudinal axis extending from the inflow end to the outflow end. The prosthetic valve also comprises a plurality of leaflets positioned to regulate a flow of blood from the inflow end to the outflow end of the frame, and a skirt assembly. The skirt assembly comprises a laminate having a textile layer sandwiched between a first encapsulation layer and a second encapsulation layer. The first and second encapsulation layers are made of an elastomer and the textile layer comprises a first set of yarns and a second set of yarns interwoven with the first set of yarns, wherein the first and second sets of yarns are non-perpendicular and non-parallel to the longitudinal axis.

An exemplary implantable prosthetic device has a coaption element and at least one anchor. The coaption element is configured to be positioned within the native heart valve orifice to help fill a space where the native valve is regurgitant and form a more effective seal. The coaption element can have a structure that is impervious to blood and that allows the native leaflets to close around the coaption element during ventricular systole to block blood from flowing from the left or right ventricle back into the left or right atrium, respectively. The coaption element can be connected to leaflets of the native valve by the anchor.

Embodiments of the present disclosure provide a prosthetic heart valve (10) comprising a valve member (14); a radially expandable and compressible support frame (12) that supports the valve member (14), wherein the support frame (12) comprises a plurality of strut members (16) interconnected to each other to form a mesh structure, an inflow end (26), an inflow end portion (24), an outflow end portion (20), and an outflow end (27); and wherein the prosthetic heart valve (10) has a curved shape that tapers inwardly from the inflow end (26) to a reduced diameter section, increases in diameter from the reduced diameter section to an intermediate section (22), and then tapers from the intermediate section to the outflow end (27).

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