Abstract: The invention is a device, system, and method for repairing heart valve function, which may include bisecting native valve leaflets for improved deployment of a prosthetic heart valve in the native valve annulus. The invention may include a catheter having a cutting element shaft with a cutting element configured to puncture a valve leaflet and/or make a controlled cut through the leaflet. The device may have an extendable foot configured to be positioned on an opposite side of the valve leaflet from the cutting element shaft. The device may include magnets to guide the cutting element and/or cutting element shaft in proper alignment with the extendable foot and to hold the elements in place during leaflet bisection.

Abstract: The invention is a device, system, and method for repairing heart valve function, which may include bisecting native valve leaflets for improved deployment of a prosthetic heart valve in the native valve annulus. The invention may include a catheter having a cutting element shaft with a cutting element configured to puncture a valve leaflet and/or make a controlled cut through the leaflet. The device may have an extendable foot configured to be positioned on an opposite side of the valve leaflet from the cutting element shaft. The device may include magnets to guide the cutting element and/or cutting element shaft in proper alignment with the extendable foot and to hold the elements in place during leaflet bisection.

Abstract: An implantable sensor device includes a sensor-support substrate, a microelectromechanical systems (MEMS) pressure sensor device mounted to the sensor-support substrate, a transduction medium applied over the pressure sensor device, and a biocompatibility layer applied over the transduction medium

Abstract: The invention is a device, system, and method for repairing heart valve function, which may include bisecting native valve leaflets for improved deployment of a prosthetic heart valve in the native valve annulus. The invention may include a catheter having a cutting element shaft with a cutting element configured to puncture a valve leaflet and/or make a controlled cut through the leaflet. The device may have an extendable foot configured to be positioned on an opposite side of the valve leaflet from the cutting element shaft. The device may include magnets to guide the cutting element and/or cutting element shaft in proper alignment with the extendable foot and to hold the elements in place during leaflet bisection.

Abstract: A septal closure and port device for implantation in the atrial septum of a patient's heart comprises an expandable frame can comprise a central portion defining a lumen, and first and second opposing end portions. The frame is configured to expand and contract between a compressed, tubular configuration for delivery through the patient's vasculature and an expanded configuration in which the first and second end portions extend radially outwardly from the opposite ends of the central portion. The device can further comprise a valve member supported on the frame and positioned to block at least the flow of blood from the left atrium to the right atrium through the lumen of the frame. The valve member is configured to permit a medical instrument inserted through the lumen and into the left atrium, such as for performing a subsequent medical procedure in the left side of the heart.

Abstract: A septal closure and port device for implantation in the atrial septum of a patient's heart includes an expandable frame with a central portion defining a lumen, and first and second opposing end portions. The frame can expand and contract between a compressed, tubular configuration for delivery through the patient's vasculature and an expanded configuration in which the first and second end portions extend radially outwardly from the opposite ends of the central portion. The device can also have a valve member supported on the frame and positioned to block at least the flow of blood from the left atrium to the right atrium through the lumen of the frame. The valve member permits a medical instrument to be inserted through the lumen and into the left atrium, for performing a subsequent medical procedure in the left side of the heart.

Abstract: The invention is a device, system, and method for repairing heart valve function, which may include bisecting native valve leaflets for improved deployment of a prosthetic heart valve in the native valve annulus. The invention may include a catheter having a cutting element shaft with a cutting element configured to puncture a valve leaflet and/or make a controlled cut through the leaflet. The device may have an extendable foot configured to be positioned on an opposite side of the valve leaflet from the cutting element shaft. The device may include magnets to guide the cutting element and/or cutting element shaft in proper alignment with the extendable foot and to hold the elements in place during leaflet bisection.

Abstract: The invention is a device, system, and method for repairing heart valve function, which may include bisecting native valve leaflets for improved deployment of a prosthetic heart valve in the native valve annulus. The invention may include a catheter having a cutting element shaft with a cutting element configured to puncture a valve leaflet and/or make a controlled cut through the leaflet. The device may have an extendable foot configured to be positioned on an opposite side of the valve leaflet from the cutting element shaft. The device may include magnets to guide the cutting element and/or cutting element shaft in proper alignment with the extendable foot and to hold the elements in place during leaflet bisection.

Abstract: A septal closure and port device for implantation in the atrial septum of a patient's heart comprises an expandable frame can comprise a central portion defining a lumen, and first and second opposing end portions. The frame is configured to expand and contract between a compressed, tubular configuration for delivery through the patient's vasculature and an expanded configuration in which the first and second end portions extend radially outwardly from the opposite ends of the central portion. The device can further comprise a valve member supported on the frame and positioned to block at least the flow of blood from the left atrium to the right atrium through the lumen of the frame. The valve member is configured to permit a medical instrument inserted through the lumen and into the left atrium, such as for performing a subsequent medical procedure in the left side of the heart.

Abstract: A septal closure and port device for implantation in the atrial septum of a patient's heart includes an expandable frame having a central portion defining a lumen, and first and second opposing end portions. The frame is configured to expand and contract between a compressed, tubular configuration for delivery through the patient's vasculature and an expanded configuration in which the first and second end portions extend radially outwardly from the opposite ends of the central portion. The device can further include a valve member supported on the frame and positioned to block at least the flow of blood from the left atrium to the right atrium through the lumen of the frame. The valve member is configured to permit a medical instrument to be inserted through the lumen and into the left atrium, such as for performing a subsequent medical procedure in the left side of the heart.

Abstract: The invention is a device, system, and method for repairing heart valve function, which may include bisecting native valve leaflets for improved deployment of a prosthetic heart valve in the native valve annulus. The invention may include a catheter having a cutting element shaft with a cutting element configured to puncture a valve leaflet and/or make a controlled cut through the leaflet. The device may have an extendable foot configured to be positioned on an opposite side of the valve leaflet from the cutting element shaft. The device may include magnets to guide the cutting element and/or cutting element shaft in proper alignment with the extendable foot and to hold the elements in place during leaflet bisection.

Abstract: Embodiments of the present disclosure are directed to implantable sealing devices, delivery apparatuses, and methods of their use, for closing surgical openings or defects in a sidewall of a vessel in a subject. In several embodiments, the disclosed implantable sealing devices, delivery apparatuses, and methods can be used to close a surgical opening in a sidewall of the heart.

Abstract: A septal closure and port device for implantation in the atrial septum of a patient's heart includes an expandable frame having a central portion defining a lumen, and first and second opposing end portions. The frame is configured to expand and contract between a compressed, tubular configuration for delivery through the patient's vasculature and an expanded configuration in which the first and second end portions extend radially outwardly from the opposite ends of the central portion. The device can further include a valve member supported on the frame and positioned to block at least the flow of blood from the left atrium to the right atrium through the lumen of the frame. The valve member is configured to permit a medical instrument to be inserted through the lumen and into the left atrium, such as for performing a subsequent medical procedure in the left side of the heart.

Abstract: Disclosed herein are exemplary embodiments of suture securement devices that replace the need to tie knots in sutures. Some embodiments comprise an annular outer body and one or more suture engagement tabs extending inwardly from the outer body. The devices can comprise a superelastic and/or shape-memory material and have a generally in-plane initial configuration. The suture engagement portions are deformable out-of-plane to an active configuration with the outer body compressed and the tabs interlocked with each other. The device can be heat-set in the deformed configuration. The interlocked tabs exert a pinching force on sutures passing between them that restricts the sutures from sliding through the opening in one longitudinal direction.

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 multiple-fire securing device includes a hollow outer shaft, a reloader, a reloader movement assembly, a rail, and securing structures each defining an inner securing orifice. The reloader longitudinally moves within the outer shaft and has a distal end shaped to temporarily contact one of the securing structures. The rail is disposed within the reloader and has an installing location. The securing structures are disposed on the rail. The reloader movement assembly moves the reloader longitudinally in a distal direction to deliver a first securing structure to the installing location from a first proximal position and moves the reloader proximally away from the installing location without the first securing structure to a position in which the distal end of the reloader temporarily contacts a second one of the securing structures. The second and successive securing structures are moved one at a time to the installing location.

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: Embodiments of the present disclosure are directed to implantable sealing devices, delivery apparatuses, and methods of their use, for closing surgical openings or defects in a sidewall of a vessel in a subject. In several embodiments, the disclosed implantable sealing devices, delivery apparatuses, and methods can be used to close a surgical opening in a sidewall of the heart.

Abstract: Disclosed herein are exemplary embodiments of suture securement devices that replace the need to tie knots in sutures. Some embodiments comprise an annular outer body and one or more suture engagement tabs extending inwardly from the outer body. The devices can comprise a superelastic and/or shape-memory material and have a generally in-plane initial configuration. The suture engagement portions are deformable out-of-plane to an active configuration with the outer body compressed and the tabs interlocked with each other. The device can be heat-set in the deformed configuration. The interlocked tabs exert a pinching force on sutures passing between them that restricts the sutures from sliding through the opening in one longitudinal direction.

Abstract: Disclosed herein are exemplary embodiments of suture securement devices that replace the need to tie knots in sutures. Some embodiments comprise an annular outer body and one or more suture engagement tabs extending inwardly from the outer body. The devices can comprise a superelastic and/or shape-memory material and have a generally in-plane initial configuration. The suture engagement portions are deformable out-of-plane to an active configuration with the outer body compressed and the tabs interlocked with each other. The device can be heat-set in the deformed configuration. The interlocked tabs exert a pinching force on sutures passing between them that restricts the sutures from sliding through the opening in one longitudinal direction.