Abstract: Embodiments of delivery systems, devices and methods for delivering a prosthetic heart valve device to a heart chamber for expanded implementation are disclosed. More specifically, methods, systems and devices are disclosed for delivering a self-expanding prosthetic mitral valve device to the left atrium, with no engagement of the left ventricle, the native mitral valve leaflets or the annular tissue downstream of the upper annular surface during delivery, and in some embodiments with no engagement of the ventricle, mitral valve leaflets and/or annular tissue located downstream of the upper annular surface by the delivered, positioned and expanded prosthetic mitral valve device.

Abstract: Systems, devices and methods for attaching an operator-manipulatable tether(s) to the stent for: loading and/or collapsing the expandable stent into a delivery catheter or sheath, translating the collapsed stent along the delivery catheter or sheath, delivering the expandable stent into the subject heart chamber, repositioning the expandable stent as necessary within the subject heart chamber, recapturing or resheathing the expandable stent within the delivery catheter or sheath if needed, and deploying the expandable stent to, and within, the subject heart chamber.

Abstract: A device and method for predictably and controlling the collapsing of a collapsible and expandable stent for subsequent translation through a delivery sheath lumen to an anatomical target such as a heart valve or intravascular location for expansion and implantation. The loading device defines in inner lumen comprising a successively decreasing, from the proximal to the distal direction, inner diameter to a region of constant inner diameter wherein the stent is in a collapsed configuration. The device and method may provide for an at least partially collapsed configuration of the stent that may be further collapsed as a part of the implantation procedure and may comprise a stent that is pre-loaded for future use.

Abstract: Loading systems for prosthetic heart valve devices are disclosed. A loading funnel is provided within a watertight interior space that is at least partially filled or fillable with biocompatible fluid. Funnel may have a cylindrical end to which is connected a delivery catheter having a lumen that will receive the collapsed prosthetic heart valve device. An expanded prosthetic heart valve device may be placed within the funnel and pushed or pulled into the funnel which provides a predictable, reliable and repeatable surface for collapsing the prosthetic heart valve device. Ultimately the prosthetic heart valve device is collapsed and translated into the lumen of the delivery catheter for further translation therealong and release into the heart chamber of interest.

Abstract: Loading systems for prosthetic heart valve devices are disclosed. A loading funnel is provided within a watertight interior space that is at least partially filled or fillable with biocompatible fluid. Funnel may have a cylindrical end to which is connected a delivery catheter having a lumen that will receive the collapsed prosthetic heart valve device. An expanded prosthetic heart valve device may be placed within the funnel and pushed or pulled into the funnel which provides a predictable, reliable and repeatable surface for collapsing the prosthetic heart valve device. Ultimately the prosthetic heart valve device is collapsed and translated into the lumen of the delivery catheter for further translation therealong and release into the heart chamber of interest.

Abstract: A device and method for predictably and controlling the collapsing of a collapsible and expandable stent for subsequent translation through a delivery sheath lumen to an anatomical target such as a heart valve or intravascular location for expansion and implantation. The loading device defines in inner lumen comprising a successively decreasing, from the proximal to the distal direction, inner diameter alternating between two sections of decreasing diameter and two sections of constant diameter until reaching the inner diameter of the delivery sheath. A fluid-filled reservoir is provided at the proximal end of the loading device that is configured to provide moisture or wetting for materials associated with or attached to the stent that require moisture retention. Thus, as the stent is being collapsed with the loading device, at least a portion of the stent may be immersed in the fluid reservoir to preserve the subject material.

Abstract: Systems, devices and methods for attaching an operator-manipulatable tether(s) to the stent for: loading and/or collapsing the expandable stent into a delivery catheter or sheath, translating the collapsed stent along the delivery catheter or sheath, delivering the expandable stent into the subject heart chamber, repositioning the expandable stent as necessary within the subject heart chamber, recapturing or resheathing the expandable stent within the delivery catheter or sheath if needed, and deploying the expandable stein to, and within, the subject heart chamber.

Abstract: Systems, devices and methods for attaching an operator-manipulatable tether(s) to the stent for: loading and/or collapsing the expandable stent into a delivery catheter or sheath, translating the collapsed stent along the delivery catheter or sheath, delivering the expandable stent into the subject heart chamber, repositioning the expandable stent as necessary within the subject heart chamber, recapturing or resheathing the expandable stent within the delivery catheter or sheath if needed, and deploying the expandable stent to, and within, the subject heart chamber.

Abstract: The invention provides methods, devices and systems for delivering, positioning and/or repositioning an expandable prosthetic heart valve in a patient's heart chamber. At least one non-looped wire and looped wire pair is operatively connected with an expanded prosthetic heart valve that is collapsed within a delivery catheter lumen having its distal end positioned in the subject heart chamber. The collapsed prosthetic heart valve is translated through the delivery catheter lumen to and out of its distal end where the prosthetic heart valve expands to a working configuration. The wire(s) of the non-looped and looped wire pair may be manipulated by pulling proximately or pushing distally to position or reposition the expanded prosthetic stent into position, then released from connection with the positioned stent and withdrawn from the patient.

Abstract: A loading, delivery, deployment and positioning system for a prosthetic heart valve device includes a stent that is biased to expand and adapted to collapse into the lumen of a delivery catheter. A torque wire of the system includes a distal threaded region, has length that is longer than a length of the delivery catheter, and is adapted for movement within the delivery catheter lumen. A stent cap is non-rotationally attached at or near the top of the stent and defines a channel and a pair of lateral locking grooves therethrough. A male engagement member of the system includes a threaded region adapted to threadingly engage the threaded region of the torque wire, a stem region extending distally from the threaded region; and engagement handles extending laterally from a distal end of the stem region, the engagement handles being adapted to detachably engage the stent cap.

Abstract: Loading systems for prosthetic heart valve devices are disclosed. A loading funnel is provided within a watertight interior space that is at least partially filled or fillable with biocompatible fluid. Funnel may have a cylindrical end to which is connected a delivery catheter having a lumen that will receive the collapsed prosthetic heart valve device. An expanded prosthetic heart valve device may be placed within the funnel and pushed or pulled into the funnel which provides a predictable, reliable and repeatable surface for collapsing the prosthetic heart valve device. Ultimately the prosthetic heart valve device is collapsed and translated into the lumen of the delivery catheter for further translation therealong and release into the heart chamber of interest.

Abstract: Embodiments of delivery systems, devices and methods for delivering a prosthetic heart valve device to a heart chamber for expanded implementation are disclosed. More specifically, methods, systems and devices are disclosed for delivering a self-expanding prosthetic mitral valve device to the left atrium, with no engagement of the left ventricle, the native mitral valve leaflets or the annular tissue downstream of the upper annular surface during delivery, and in some embodiments with no engagement of the ventricle, mitral valve leaflets and/or annular tissue located downstream of the upper annular surface by the delivered, positioned and expanded prosthetic mitral valve device.

Abstract: Embodiments of delivery systems, devices and methods for delivering a prosthetic heart valve device to a heart chamber for expanded implementation are disclosed. More specifically, methods, systems and devices are disclosed for delivering a self-expanding prosthetic mitral valve device to the left atrium, with no engagement of the left ventricle, the native mitral valve leaflets or the annular tissue downstream of the upper annular surface during delivery, and in some embodiments with no engagement of the ventricle, mitral valve leaflets and/or annular tissue located downstream of the upper annular surface by the delivered, positioned and expanded prosthetic mitral valve device.

Abstract: Embodiments of delivery systems, devices and methods for delivering a prosthetic heart valve device to a heart chamber for expanded implementation are disclosed. More specifically, methods, systems and devices are disclosed for delivering a self-expanding prosthetic mitral valve device to the left atrium, with no engagement of the left ventricle, the native mitral valve leaflets or the annular tissue downstream of the upper annular surface during delivery, and in some embodiments with no engagement of the ventricle, mitral valve leaflets and/or annular tissue located downstream of the upper annular surface by the delivered, positioned and expanded prosthetic mitral valve device.

Abstract: The invention provides methods, devices and systems for delivering, positioning and/or repositioning an expandable prosthetic heart valve in a patient's heart chamber. At least one non-looped wire and looped wire pair is operatively connected with an expanded prosthetic heart valve that is collapsed within a delivery catheter lumen having its distal end positioned in the subject heart chamber. The collapsed prosthetic heart valve is translated through the delivery catheter lumen to and out of its distal end where the prosthetic heart valve expands to a working configuration. The wire(s) of the non-looped and looped wire pair may be manipulated by pulling proximately or pushing distally to position or reposition the expanded prosthetic stent into position, then released from connection with the positioned stent and withdrawn from the patient.

Abstract: A device and method for predictably and controlling the collapsing of a collapsible and expandable stent for subsequent translation through a delivery sheath lumen to an anatomical target such as a heart valve or intravascular location for expansion and implantation. The loading device defines in inner lumen comprising a successively decreasing, from the proximal to the distal direction, inner diameter alternating between two sections of decreasing diameter and two sections of constant diameter until reaching the inner diameter of the delivery sheath. A fluid-filled reservoir is provided at the proximal end of the loading device that is configured to provide moisture or wetting for materials associated with or attached to the stent that require moisture retention. Thus, as the stent is being collapsed with the loading device, at least a portion of the stent may be immersed in the fluid reservoir to preserve the subject material.

Abstract: A device and method for predictably and controlling the collapsing of a collapsible and expandable stent for subsequent translation through a delivery sheath lumen to an anatomical target such as a heart valve or intravascular location for expansion and implantation. The loading device defines in inner lumen comprising a successively decreasing, from the proximal to the distal direction, inner diameter to a region of constant inner diameter wherein the stent is in a collapsed configuration. The device and method may provide for an at least partially collapsed configuration of the stent that may be further collapsed as a part of the implantation procedure and may comprise a stent that is pre-loaded for future use.

Abstract: An expandable and collapsible stent comprising prosthetic leaflets attached to an inner valve support section that extends radially upward into an outer stent section. A transition stent section is disposed between the inner valve support section and the outer stent section. Each of the outer stent section, the inner valve support section and the transition stent section may comprise struts or the equivalent that form and define cells having a pattern, wherein each section may comprise a different cell pattern. Transition stent section preferably comprises struts that are of equal curvature, with adjacent struts equally spaced from each other to allow nested collapsing of the transition stent section struts. A boss section extending downstream away from the inner valve support section may be provided to aid in alignment and retention of the expanded stent and may comprise a shape that is complementary to a heart chamber annulus.

Abstract: Devices and methods for supplementing and/or replacing native cardiac valve functionality, e.g., the mitral valve with a single prosthetic leaflet. An exemplary device is directed to dysfunctional mitral valves. In some cases, the entire device, including the single prosthetic leaflet, will be arranged entirely above the dysfunctional mitral valves and, therefore, disposed entirely within the left atrium. In other cases, the valve support and/or single prosthetic leaflet may extend a distance into the annulus between the left atrium and left ventricle. In some cases, the device will not physically interact with the native leaflets. In other cases, the device may physically interact with the native leaflets.

Abstract: Embodiments of delivery systems, devices and methods for delivering a prosthetic heart valve device to a heart chamber for expanded implementation are disclosed. More specifically, methods, systems and devices are disclosed for delivering a self-expanding prosthetic mitral valve device to the left atrium, with no engagement of the left ventricle, the native mitral valve leaflets or the annular tissue downstream of the upper annular surface during delivery, and in some embodiments with no engagement of the ventricle, mitral valve leaflets and/or annular tissue located downstream of the upper annular surface by the delivered, positioned and expanded prosthetic mitral valve device.