Abstract: A prosthetic apparatus configured for implantation in the native mitral valve region of the heart includes a main body that is self-expandable from a compressed state to a radially expanded state. The prosthetic apparatus comprises at least one ventricular anchor coupled to the main body and disposed outside of the main body for capturing a native valve leaflet between the anchor and an outer surface of the main body. In one preferred method of implantation, the prosthetic apparatus is rotated within the native mitral valve region such that a portion of the anchor moves horizontally behind adjacent chordae for anchoring the prosthetic apparatus in the native mitral valve.

Abstract: An annuloplasty ring having a three-dimensional discontinuous form generally arranged about an axis with two free ends that are axially offset. The ring is particularly suited for repair of the tricuspid valve, and more closely conforms to the annulus shape. The ring is more flexible in bending about radially extending axes than about the central axis. The ring may have an inner structural support covered by a pliable sleeve and/or a fabric tube. The structural support may have a varying cross-section, such as a C-shaped cross-section in a mid-section between two free ends and a rectangular cross-section at the free ends.

Abstract: This disclosure pertains generally to prosthetic devices and related methods for helping to seal native heart valves and prevent or reduce regurgitation therethrough, as well as devices and related methods for implanting such prosthetic devices. In some cases, a spacer having a single anchor can be implanted within a native heart valve. In some cases, a spacer having dual anchors can be implanted within a native heart valve. In some cases, devices can be used to extend the effective length of a native heart valve leaflet.

Abstract: Described herein are systems and methods for securing sutures that obviate the need for tying knots. Disclosed suture clips can comprise a first part and a second part that are attachable together to secure one or more sutures in a suture engagement region between the first and second parts. The first and second parts can include locking projections and slots at opposing ends of the suture engagement region to align the two parts, contain sutures, and/or secure the clip onto sutures. When the first and second parts are attached together, first engagement features of the first part inter-engage with second engagement features of the second part to grip and secure sutures within suture engagement region. An exemplary delivery device has hold a plurality of such suture clips in an elongated shaft portion and deploy the clips successively to sutures via actuation of a handle portion.

Abstract: The disclosure generally relates to a patient monitoring and display system. The system allows a clinician to trigger the occurrence of a clinical event, and record a patient's status following the clinical event. The system calculates and displays a change in a patient's status resulting from the clinical event. The system allows multiple parameters to be tracked and displayed on a single screen. The system can also display various animated organs, such as a heart or a lung, corresponding to an operation of the organs in the patient.

Abstract: Embodiments of a radially collapsible and expandable prosthetic heart valve are disclosed. A valve frame can have a tapered profile when mounted on a delivery shaft, with an inflow end portion having a smaller diameter than an outflow end portion. The valve can comprise generally V-shaped leaflets, reducing material within the inflow end of the frame. An outer skirt can be secured to the outside of the inflow end portion of the frame, the outer skirt having longitudinal slack when the valve is expanded and lying flat against the frame when the valve is collapsed. A diagonally woven inner skirt can elongate axially with the frame. Side tabs of adjacent leaflets can extend through and be secured to window frame portions of the frame to form commissures. The window frame portions can be depressed radially inward relative to surrounding frame portions when the valve is crimped onto a delivery shaft.

Abstract: A system and method for repairing a human heart uses a catheter with an extendable tip and multiple tissue fasteners. The catheter is advanced into a human heart with the extendable tip adjacent a first tissue portion. The extendable tip is extended to form a tissue-receiving opening, the first tissue portion is positioned within the tissue-receiving opening, and the extendable tip is withdrawn to mechanically hold the first tissue portion. A first tissue fastener is secured to the first tissue portion, which is then released from the tissue-receiving opening. A second tissue fastener may subsequently be passed through a second tissue portion.

Abstract: The invention is a system and method for accurately positioning a prosthetic valve such as a prosthetic heart valve at a desired position for deployment. The invention includes extendable positioning elements which provide tactile feedback to a user to confirm proper positioning of the catheter with respect to the native valve annulus. During delivery, the extendable positioning elements lie against the catheter, over the prosthetic valve and expandable balloon, providing a low profile for advancing the catheter to the desired treatment location via small passages such as body lumens. Prior to valve deployment, the positioning elements are extended and brought into contact with tissue of the native annulus to confirm the proper positioning of the delivery system and prosthetic valve.

Abstract: A prosthetic heart valve having an internal support frame with a continuous, undulating leaflet frame defined therein. The leaflet frame has three cusp regions positioned at an inflow end intermediate three commissure regions positioned at an outflow end thereof. The leaflet frame may be cloth covered and flexible leaflets attached thereto form occluding surfaces of the valve. The support frame further includes three cusp positioners rigidly fixed with respect to the leaflet frame and located at the outflow end of the support frame intermediate each pair of adjacent commissure regions. The valve is desirably compressible so as to be delivered in a minimally invasive manner through a catheter to the site of implantation. Upon expulsion from catheter, the valve expands into contact with the surrounding native valve annulus and is anchored in place without the use of sutures.

Abstract: Disclosed herein are suture clip delivery devices that can be loaded with several flat, disk-shaped suture clips and can deploy the suture clips one after another onto respective sutures without reloading the device with additional suture clips. An exemplary device includes a handle portion with an actuation mechanism that is coupled to a shaft portion that holds and deploys the suture clips. The shaft portion includes a mandrel on which the suture clips are mounted and a retainer that restricts the suture clips from moving proximally when the actuation mechanism pulls the mandrel proximally, which causes a distal-most suture clip to slide off the mandrel and be deployed onto one or more suture. The mandrel and remaining suture clips can them move distally to prepare to deploy the next suture clip.

Abstract: A device, system, and method for providing access to, and sealing of, a body organ includes an implant device. An implant device has a main body having an internal access lumen, with a plurality of prongs extending from a distal end of the main body. The main body can include two lumens, one slidable within the other, to form a single continuous lumen with an adjustable length. The main body has an expanded configuration with an expanded diameter, and an unexpanded configuration with an unexpanded diameter. The prongs have a generally straight configuration where they extend distally of the distal end of the main body, and a bent configuration where the prongs bend around so that their tips extend proximally of the distal end of the main body. The device may include a hemostatic barrier to prevent fluid leakage therethrough when the main body is in the unexpanded configuration.

Abstract: A prosthetic heart valve configured to replace a native heart valve and having a support frame configured to be reshaped into an expanded form in order to receive and/or support an expandable prosthetic heart valve therein is disclosed, together with methods of using same. The prosthetic heart valve may be configured to have a generally rigid and/or expansion-resistant configuration when initially implanted to replace a native valve (or other prosthetic heart valve), but to assume a generally expanded form when subjected to an outward force such as that provided by a dilation balloon or other mechanical expander.

Abstract: A quick-connect heart valve prosthesis that can be quickly and easily implanted during a surgical procedure is provided. The heart valve includes a substantially non-expandable, non-compressible prosthetic valve and a plastically-expandable stent frame, thereby enabling attachment to the annulus without sutures. The prosthetic valve may be a commercially available valve with a sewing ring and the stent frame attached thereto. The stent frame may expand from a conical deployment shape to a conical expanded shape, and may have a cloth covering its entirety as well as a plush sealing flange around its periphery to prevent paravalvular leaking.

Abstract: Disclosed herein are representative embodiments of methods, apparatus, and systems used to deliver a prosthetic heart valve to a deficient valve. In one embodiment, for instance, a support member is positioned to at least partially surround the native leaflets of a valve. A locking member is used to couple both ends of the support member, forming a support band. An expandable prosthetic heart valve is delivered into the native heart valve and expanded while the expandable prosthetic valve is at least partially within the support band, thereby causing one or more of the native leaflets of the native heart valve to be frictionally secured between the support band and the expanded prosthetic heart valve.

Abstract: A medical device configured for placement in a blood vessel, in which an elastic tube extends between first and second expandable anchoring stents. The elastic tube is constructed of a resilient material that deflects outward in response to increased blood pressure of a heart beat and that moves back inward as the blood pressure drops, thereby aiding the heart's pumping action.

Abstract: Disclosed herein is a prosthetic heart valve, and associated methods therefore, configured to replace a native heart valve, and having a support frame configured to be reshaped into an expanded form in order to receive and/or support an expandable prosthetic heart valve therein. The prosthetic heart valve is configured to have an expansion-resistant configuration when initially implanted to replace a native valve (or other prosthetic heart valve), but to assume a generally expanded form when subjected to an outward force such as that provided by a dilation balloon or other mechanical expander.

Abstract: A method for delivering a self-expanding prosthetic heart valve comprises positioning the prosthetic heart valve in an annulus of a native heart valve while mounted in a radially compressed state in a delivery cylinder, the delivery cylinder coupled to a distal end portion of the torque shaft, and rotating a torque shaft coupled to the delivery cylinder. Rotating the torque shaft retracts the delivery cylinder, thereby exposing the prosthetic heart valve, allowing the prosthetic heart valve to self-expand in the native valve annulus. In some embodiments, the torque shaft is rotated by a motor disposed in a handle at a proximal end of the delivery device.

Abstract: This disclosure relates generally to systems and methods for occluding vessels of the heart and inducing cardioplegic arrest to facilitate the performance of cardiac procedures. An aortic occlusion and perfusion device includes an expandable member configured to expand within the aorta to secure the device within the aorta, and a catheter extending proximally from the expandable member and in fluid communication with the expandable member. The catheter can define a plurality of openings along its length through which blood can pass with one or more of the openings located proximal to the expandable member and one or more of the openings located within the expandable member. The device can also include a flow control sheath disposed around the catheter member such that axial movement of the flow control sheath relative to the catheter selectively occludes or uncovers one or more of the openings located proximal to the expandable member.

Abstract: 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.

Abstract: Systems, dies, and methods are provided for processing pericardial tissue. The method includes positioning a die-cut assembly over the pericardial tissue, the die-cut assembly including a die having a plate, a die pattern, and an opening, the die pattern attached to the plate, the opening formed in the plate to provide access to the pericardial tissue, and measuring a thickness of the tissue through the opening. The die-cut assembly may be mounted for automated vertical movement, and a platen on which the tissue is placed is capable of automated horizontal movement. Different target areas on the tissue can be assessed by measuring the thickness through the die, and when an area is deemed suitable the die pattern cuts a shape therefrom. The system is useful for cutting uniform thickness heart valve leaflets, and can be automated to speed up the process.