Abstract: A prosthetic valve having a frame, a leaflet structure having leaflets forming a primary valve mounted inside the frame, and at least one secondary valve is disclosed. The secondary valve can have a valve element with stationary portion and a detached portion, and at least one aperture in at least one leaflet. The secondary valve can be formed by a portion of at least one leaflet.

Abstract: An implantable prosthetic valve that is radially collapsible to a collapsed configuration and radially expandable to an expanded configuration includes an annular frame including a plurality of angled strut members, a plurality of leaflets disposed within the frame and secured to the frame, and a skirt member secured to the frame. The skirt member is disposed about an edge portion of a leaflet of the plurality of leaflets, and the skirt member includes a plurality of extension portions wrapped around at least one strut member. A cord member is threaded through at least a portion of the plurality of extension portions in a direction along an axis of the at least one strut member to secure the skirt member to the at least one strut member.

Abstract: A method and apparatus for non-invasively determining a blood oxygen saturation level within tissue of an internal organ is provided. The method includes: applying a near infrared spectrophotometric sensor on an external surface of an organ; operating the sensor to emit light from a light source directly into the tissue of the organ at a first tissue location, and to sense the emitted light at a second tissue location, which emitted light has traveled through the tissue between the first and second tissue locations, and to produce signals representative of the intensity of the sensed emitted light; using a processor to execute instructions, which instructions cause the processor to: determine an attenuation value of the emitted light for each wavelength, and determine a blood oxygen saturation level of the organ tissue using the determined attenuation values for each of the plurality of wavelengths.

Abstract: A method of delivering a prosthetic heart valve to the aortic valve annulus while a patient's heart is beating is disclosed. The method includes accessing the left ventricle through an intercostal incision and forming a puncture in the left ventricle. A guidewire is advanced into the left ventricle and through the native aortic valve. An introducer is passed over the guidewire and into the left ventricle. A valve delivery device is advanced over the guidewire and through the introducer until a prosthetic heart valve positioned thereon is located within the native aortic valve. The prosthetic heart valve is then radially expanded within the aortic valve annulus for replacing the function of the native aortic valve.

Abstract: Disclosed is a system to provide adaptive tuning through a control system to a finger cuff connectable to a patient's finger to be used in measuring the patient's blood pressure in the patient's artery by a blood pressure measurement system utilizing a volume clamp method. When the finger cuff is placed around the patient's finger, the bladder and the LED-PD pair aid in measuring the patient's blood pressure by the blood pressure measurement system utilizing the volume clamp method, wherein the adaptive tuning system: applies a first pressure impulse and measures a pleth versus time response; from the pressure versus time response, determines pleth servo gains that compensate for delays in a pleth response of the finger; and uses the determined pleth servo gains in the control system in measuring the patient's blood pressure by the blood pressure measurement system utilizing the volume clamp method.

Abstract: An implantable prosthetic valve comprises a radially collapsible and expandable annular frame and a leaflet structure that regulates the flow of blood through the prosthetic valve. A fabric inner skirt is positioned along an inner surface of the frame. The inner skirt comprises a first set of yarns extending in a first direction and a second set of yarns extending in a second direction and woven with the first set of yarns. The yarns of the first set are thinner than the yarns of the second set and are woven with the second set of yarns such that an inner surface of the skirt is formed from more of the yarns of the first set than the yarns of the second set and an outer surface of the skirt is formed from more of the yarns of the second set than the yarns of the first set.

Abstract: An implantable prosthetic valve can include a radially expandable and collapsible annular frame having an inflow end and an outflow end. A valvular structure can be positioned within the frame. A plurality of sealing members can be positioned around an outer surface of the frame, wherein the sealing members are configured to transform from an unfurled configuration extending along the outer surface of the frame when the frame is in the radially collapsed configuration to a coiled configuration when the frame is radially expanded to the radially expanded configuration.

Abstract: An expandable sheath is disclosed herein, which has a first polymeric layer and a braided layer positioned radially outward of the first polymeric layer. The braided layer includes a plurality of filaments braided together. The expandable sheaths further include a resilient elastic layer positioned radially outward of the braided layer. The elastic layer is configured to apply radial force to the braided layer and the first polymeric layer. The expandable sheath further includes a second polymeric layer positioned radially outward of the elastic layer and bonded to the first polymeric layer such that the braided layer and the elastic layer are encapsulated between the first and second polymeric layers. Methods of making and using the devices disclosed herein are also disclosed, as are crimping devices that may be used in methods of making the devices disclosed herein.

Abstract: A prosthetic valve assembly includes a radially expandable and compressible annular frame. The frame includes a plurality of interconnected struts, which include a plurality of inner struts and a plurality of outer struts. The inner struts overlap adjacent outer struts at a plurality of pivot joints. Radial expansion or compression of the annular frame causes the inner struts to pivot relative to the outer struts at the pivot joints. The assembly also includes a valvular structure inside the frame having a plurality of leaflets that regulate blood flow through the frame. Some of the struts include recessed portions and other struts that cross the recessed portions include segments that are seated in the recessed portions at the pivot joints. This provides a continuous or flush inner or outer surface of the frame.

Abstract: Anchoring or docking devices configured to be positioned at a native valve of a human heart and to provide structural support for docking a prosthetic valve therein. The docking devices can have coiled structures that define an inner space in which the prosthetic valve can be held. The docking devices can have enlarged end regions with circular or non-circular shapes, for example, to facilitate implantation of the docking device or to better hold the docking device in position once deployed. The docking devices can be laser-cut tubes with locking wires to assist in better maintaining a shape of the docking device. The docking devices can include various features to promote friction, such as frictional cover layers. Such docking devices can have ends configured to more securely attach the cover layers to cores of the docking devices.

Abstract: An assembly can comprise a radially expandable and compressible annular frame, at least one linear actuator assembly coupled to the frame and at least one locking mechanism coupled to the frame. The linear actuator can be configured to apply a distally directed force and/or a proximally directed force to the frame to radially expand or compress the frame. The locking mechanism can comprise a first sleeve member connected to the frame at a first location, a second sleeve member having internal threads and being connected to the frame at a second location, and a first screw configured to engage the internal threads of the second sleeve member to retain the frame in a radially expanded state.

Abstract: An exemplary valve repair device for repairing a native valve of a patient includes: a coaption element formed from a strip of material; a pair of extension members; a pair of paddles formed from the strip of material and connected to the coaption element; and a cap attached to the paddles. The paddles are movable between an open position and a closed position, are disposed over the extension member, and are configured to attach to the native valve of the patient. Movement of the cap toward the coaption element causes the pair of paddles to move to the closed position, and movement of the cap away from the coaption element causes the pair of paddles to move to the open position. The cap has a retention body for receiving attachment portions of the extension members, a retaining nut, and a retaining bolt for securing the retaining nut.

Abstract: Embodiments of a crimping device for crimping a radially expandable and compressible prosthetic valve are disclosed. A crimping device can comprise a housing configured to receive a prosthetic valve in a radially expanded state. The housing member can include a funnel segment and an outlet in communication with the funnel segment. The crimping device can further comprise an actuator rotatably coupled to the housing, wherein rotation of the actuator relative to the housing causes the prosthetic valve to move axially through the funnel segment such that at least a portion of the prosthetic valve compresses radially by engagement with the funnel segment and exits the crimping device via the outlet.

Abstract: The present invention relates to devices and methods for improving the function of a defective heart valve, and particularly for reducing regurgitation through an atrioventricular heart valve—i.e., the mitral valve and the tricuspid valve. For a tricuspid repair, the device includes an anchor deployed in the tissue of the right ventricle, in an orifice opening to the right atrium, or anchored to the tricuspid valve. A flexible anchor rail connects to the anchor and a coaptation element on a catheter rides over the anchor rail. The catheter attaches to the proximal end of the coaptation element, and a locking mechanism fixes the position of the coaptation element relative to the anchor rail. Finally, there is a proximal anchoring feature to fix the proximal end of the coaptation catheter subcutaneously adjacent the subclavian vein. The coaptation element includes an inert covering and helps reduce regurgitation through contact with the valve leaflets.

Abstract: An implantable prosthetic device comprises a frame comprising a first set of first struts and a second set of second struts. The first struts are pivotably connected to each other at a plurality of distal and proximal apices at distal and proximal ends of the frame. The second struts are pivotably connected to each other at a plurality of distal and proximal apices at the distal and proximal ends of the frame. The first struts have a first thickness, and the second struts have a second thickness, wherein the first thickness is greater than the second thickness. One or more actuators are coupled only to one or more corresponding pairs of a distal apex and a proximal apex formed by the first struts, wherein the one or more actuators are configured to apply axially directed forces to the frame to radially expand the frame.

Abstract: Disclosed are techniques for construction of prosthetic heart valves, particularly techniques for attachment of scalloped edges of valvular leaflets to struts of mechanical frames using sutures and/or other materials as intermediate coupling members. In some embodiments, the scalloped edges of the leaflets are coupled to the segments of the struts of the frame via suture loops that are oriented transverse to the scalloped edges of the leaflets. In some embodiments, central portions of scallop line segments are attached to the scalloped edges of the leaflets and are not attached to the frame. In some embodiments, strut segments are tapered to limit translation of suture loops. In some embodiments, a cloth strip couples the scalloped edges of the leaflets to frame struts. In some embodiments, the scalloped edge is attached to adjacent segments of intersecting struts via sliding suture loops, where the adjacent segments join at a common pivot joint.

Abstract: A prosthetic heart valve and delivery device for delivering the prosthetic heart valve to a target implantation site, which reduce contact between the prosthetic heart valve and a delivery sheath through which the delivery device is advanced to the target implantation site, is disclosed. As one example, a prosthetic heart valve may comprise a frame including a first end with a plurality of apices spaced apart from one another around a circumference of the first end and a cover element covering the plurality of apices. The cover element may include a cushioning element or a bio-resorbable element.

Abstract: This application relates to methods, systems, and apparatus for replacing native heart valves with prosthetic heart valves and treating valvular insufficiency. In a representative embodiment, a support frame configured to be implanted in a heart valve comprises a main body formed by formed by a plurality of inner members forming an inner clover and a plurality of outer members forming an outer clover. The support frame can include gaps located between inner members of the plurality of inner members and outer members of the plurality of outer members. The inner clover can be radially inside the outer clover, and the outer clover can have larger dimensions than the inner clover. The support frames herein can be radially expandable and collapsible.

Abstract: Valve holders and introducers for delivering a prosthetic heart valve to an implant site are configured to facilitate insertion of prosthetic valves through small incisions or access sites on a patient's body. The valve holders can also be configured to reduce or eliminate the occurrence of suture looping or other damage to the prosthetic valve during implantation. A valve holder according to embodiments of the invention includes features that reduce or eliminate mistakes during implantation of the prosthetic valves, such as a handle that prevents implantation of the valve prior to proper deployment or adjustment of the holder. An introducer is provided which can facilitate temporary deformation of a nitinol prosthetic valve to pass between adjacent ribs of a patient without rib spreading. Valves are provided having a wireform and stiffener band made of materials that exhibit superelastic properties.

Abstract: A prosthetic heart valve includes a support frame and a plurality of leaflets disposed inside the support frame. The support frame extends between an inflow end and an outflow end and includes a leaflet frame and a plurality of positioning members coupled to the leaflet frame. The leaflet frame has an undulating shape at the outflow end of the support frame and includes a plurality of commissure regions spaced apart from each other. The positioning members are disposed between the commissure regions of the leaflet frame and extend radially outwardly relative to the leaflet frame. The positioning members are configured to contact native tissue and anchor the support frame relative to the native tissue. The leaflets are coupled to the commissure regions of the leaflet frame. The leaflets are configured to allow flow in a first direction and to substantially block flow in an opposite direction.