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: Methods for replacing a native heart valve. An anchor comprises coils adapted to support a heart valve prosthesis. The anchor is positioned at a native heart valve. An expansible heart valve prosthesis is delivered into the anchor and expanded inside the coils. This moves at least one coil from a first diameter to a second, larger diameter while securing the anchor and the heart valve prosthesis relative to each other. The heart valve prosthesis comprises a seal on the expansible heart valve prosthesis. Additional apparatus and methods are disclosed.

Abstract: Methods and systems for replacing a native heart valve are disclosed. A system comprises a delivery catheter having a deflectable distal tip configured to bend in one or more directions relative to a native annulus of a native heart valve when the distal tip is positioned within an atrium of a heart and a helical anchor configured to be carried within the delivery catheter in a delivery configuration and to be axially movable relative to the deflectable distal tip. The helical anchor has a coiled configuration comprising a plurality of turns after being delivered from the deflectable distal tip into the heart, where the coiled configuration is configured to support a heart valve prosthesis.

Abstract: A system for implanting a repair device onto a native valve of a natural heart to repair the native valve of a patient during a non-open-heart procedure. The system includes a surgical a valve repair device for repairing a native valve of a patient including a pair of paddles, and a pair of gripping members. The paddles are movable between an open position and a closed position, in which the paddles are moved to the open position by moving a pivot point of each paddle in an outward direction and pivoting each of the paddles about the pivot point of the paddle. The paddles and the gripping members are configured to attach to the native valve of the patient when the paddles are in the closed position.

Abstract: A system for implanting a repair device onto a native valve of a natural heart to repair the native valve of a patient during a non-open-heart procedure. The system includes a surgical delivery instrument and a valve repair device. The surgical delivery instrument has at least one lumen. The valve repair device is configured to be delivered through the lumen of the surgical delivery instrument and to be attached to a native valve of a patient. The valve repair device includes a pair of paddles and a pair of gripping members. The paddles are movable between an open position and a closed position, and the paddles are configured to flex upon being attached to the native valve of a patient. The paddles and the gripping members are configured to attach to the native valve of the patient.

Abstract: The present disclosure provides a stabilizing system for a medical device. The stabilizing system includes a table and a stabilizing unit. The table includes a table having a base member and an upper member. The upper member is removably mounted on top of an upper portion of the base member. The upper member includes an inverted T-shaped slot. The stabilizing unit includes a base portion and a support member. The base portion has side rails. The support member is disposed on the base portion. The support member is configured to receive and support a catheter assembly comprising a catheter and a catheter handle. The stabilizing unit is mounted to the upper member of the table by sliding the side rails into the inverted T-shaped slot.

Abstract: Systems and methods for replacing a native heart valve. An anchor comprises multiple coils adapted to support a heart valve prosthesis. At least one of the coils is normally at a first diameter, and is expandable to a second, larger diameter upon application of radial outward force from within the anchor. An expansible heart valve prosthesis is provided and is configured to be delivered into the anchor and expanded inside the multiple coils. This moves at least one coil from the first diameter to the second diameter while securing the anchor and the heart valve prosthesis relative to each other. The system further includes a seal on the anchor that can prevent at least some blood leakage after implantation of the heart valve prosthesis in the helical anchor. Additional apparatus and methods are disclosed.

Abstract: The present disclosure provides a stabilizing unit for a medical device. The stabilizing unit includes a retaining arm having a surface configured to abut a surface of the medical device. The stabilizing unit also includes a stabilizing fork having a slot configured to receive the medical device. A biasing member is in contact with the stabilizing fork and is configured to urge the slot of the stabilizing fork towards the retaining arm. When the medical device is placed in the slot of the stabilizing fork, the basing member urges the stabilizing fork against an adjacent surface of the medical device, and an opposing surface of the medical device against the retaining arm.

Abstract: A flexible delivery catheter can be used to deploy valve repair and replacement devices at an implant site for the repair or replacement of poorly functioning native heart valves. Such a catheter can include a flexible tube having a plurality of links. A control wire can be connected to the plurality of links, such that applying tension to the control wire causes the flexible tube to bend.

Abstract: In one embodiment, an expandable positioning device for improving the coaptation of heart valve leaflets is provided. The expandable positioning device can include one or more expandable members. A first expandable member extends below a leaflet in order to reposition the leaflet to improve coaptation with another leaflet. A second expandable member extends above a leaflet in order to secure the expandable delivery device at the implantation site. The expandable positioning device can include a neck that is inserted through the leaflet on which the device is implanted. The expandable positioning device can include a coupling member to releasably couple the device to a delivery device. One or more sealing members can be included in the expandable positioning device to maintain a desired level of expansion of the one or more expandable members.

Abstract: A system for implanting a repair device onto a native valve of a natural heart to repairing the native valve of a patient during a non-open-heart procedure. The system includes a surgical delivery instrument, a valve repair device, and a gripper control mechanism. The surgical delivery instrument has at least one lumen. The valve repair device is configured to be delivered through the lumen of the surgical delivery instrument and to be attached to a native valve of a patient. The valve repair device includes a pair of paddles, and at least four gripping members. The paddles are movable between an open position and a closed position, and the paddles and the at least four gripping members are configured to attach to the native valve of a patient. The gripper control mechanism is configured to independently move each of the at least four gripping members.

Abstract: A valve repair device for repairing a native valve of a patient includes a spacer element, a pair of paddles, and a pair of gripping members. The pair of paddles is coupled to the spacer element. The pair of gripping members is disposed between the pair of paddles. The paddles and the gripping members are configured to attach to leaflets of a heart valve. The spacer element extends past side edges of the gripping members, extends past side edges of the paddles, or extends past the side edges of both the gripping members and the paddles.

Abstract: An exemplary valve repair system for repairing a native valve of a patient during a non-open heart procedure includes a delivery device and a valve repair device. The valve repair device includes a pair of gripping members that are configured to attach to the native valve of the patient. A gripper control mechanism is configured to independently engage and move each of the gripping members.

Abstract: A valve repair device for repairing a native valve of a patient. The valve repair device includes a compressible spacer element, a pair of paddles, and a pair of gripping members. The pair of paddles are coupled to the spacer element. The pair of gripping members are disposed between the pair of paddles. The paddles and the gripping members are configured to attach to leaflets of a heart valve.

Abstract: A system for implanting a repair device onto a native valve of a natural heart to repairing the native valve of a patient during a non-open-heart procedure. The system includes a paddle and a gripping member. The paddle is movable between an open position and a closed position. The gripping member has a weakened portion and a barbed portion. The barbed portion is configured to secure the gripping member to valve tissue of the native valve of the patient. A gripper control mechanism is configured to move the gripping member between an open position and a closed position. The gripper control mechanism comprises a suture removably attached to the gripping member at a first connection point and a pushing member configured to engage the gripping member at a second connection point. The weakened portion is between the first and second connection points.

Abstract: An exemplary valve repair device for repairing a native valve of a patient has a pair of paddles, a pair of gripping members, and at least one latch member. The paddles are movable between an open position and a closed position. The paddles and/or the gripping members are configured to attach to the native valve of the patient. When the paddles are in the closed position, the latch members latch the paddles in the closed position.

Abstract: A system for implanting a repair device onto a native valve of a natural heart to repair the native valve of a patient during a non-open-heart procedure. The system includes a base assembly, a pair of paddles, and a pair of gripping members. The base assembly includes a shaft and a coupler attached to the shaft such that the coupler can be moved along the shaft. The paddles are movable between an open position, a closed position and a bailout position. The paddles and the gripping members are configured to attach to the native valve of the patient. Movement of the coupler along the shaft causes the paddles to move between the open position, the closed position, and the bailout position. When the paddles are in the bailout position, a bailout angle between each paddle of the pair of paddles and the shaft is greater than or equal to 120 degrees.

Abstract: A system for implanting a repair device onto a native valve of a natural heart to repair the native valve of a patient during a non-open-heart procedure. The system includes a base assembly having a plurality of pivoting links, a pair of paddles attached to the base assembly, a pair of gripping members attached to the base assembly, and at least one coaptation or spacer element disposed between the pair of gripping members. Movement of the pivoting links of the base assembly causes the paddles to move between an open position and a closed position. The paddles and the gripping members are configured to attach to valve leaflets of the patient. The coaptation or spacer element is configured to fill at least a portion of a gap between the valve leaflets of the patient.

Abstract: A pair of paddles are moved laterally away from one another in an exemplary method of repairing a native valve of a patient during a non-open-heart procedure. After the paddles are moved laterally away from one another, first and second gripping members are moved from an open position to a closed position to grasp valve leaflets. The paddles are then moved laterally toward one another. A cam can be used to move the paddles away from one another.

Abstract: A delivery catheter is in various embodiments configured to deliver an anchoring device to a native valve annulus of a patient's heart, where the anchoring device can better secure a prosthesis at the native annulus. The delivery catheter can includes a distal section that includes one or more spines or is laser cut to assume a particular shape for better facilitating delivery of the anchoring device at the implant site and can include a flexible tube, a first pull wire, and a second pull wire. The flexible tube can comprise a bore extending between the first end and the second end sized for passing the anchoring device therethrough. The distal portion can comprise a first flexing section and a second flexing section. Actuation of the first pull wire and the second pull wire can cause the flexible tube to move from a first configuration to a second configuration.