Methods and devices for capturing and fixing leaflets in valve repair

A method for repairing a cardiac valve having valve leaflets, each leaflet comprising a proximal side and a distal side, said method comprising:

• penetrating a first leaflet from the proximal side to the distal side with a penetrating device;
• deploying at least a portion of a first anchor having a first attached suture on the distal side of the first leaflet;
• penetrating a second leaflet from the proximal side to the distal side with a penetrating device;
• deploying at least a portion of a second anchor having a second attached suture on the distal side of the second leaflet;
• securing the first suture and the second suture together.

A device for repairing a cardiac valve, said device comprising:

• an interventional catheter configured to pass from the remote vasculature of a patient to a position within the heart adjacent to the cardiac valve;
• and
• a capture device on the interventional catheter comprising at least one distal element, wherein the distal element is protrudable radially outward and has a loop shape configured for pressing against a downstream surface of at least one leaflet,
• wherein the interventional tool further comprises at least one fixation tool for fixing the valve leaflet together, wherein the fixation tool comprises a penetrating device which has a suture and an anchor disposed at the distal end of the suture.

A method for repairing a cardiac valve having valve leaflets, said method comprising:

• accessing a patient's vasculature remote from the heart;
• advancing an interventional tool having a capturing device through the vasculature to a location near the cardiac valve;
• applying an upward force against a downstream surface of at least one leaflet with the capturing device to reposition at least one leaflet so as to reduce leakage through the valve during ventricular systole,
• wherein the interventional tool comprises an elongate shaft having a proximal end and a distal end and the capture device is disposed near the distal end, wherein the capture device comprises at least one distal element capable of protruding radially outward from the shaft and wherein the applying step includes atraumatically pressing the distal element against the downstream surface of the leaflet;
• and
• adjusting the length of protrusion of the distal element from the shaft, wherein adjusting the length comprises retracting or extending the distal element.

A kit for repairing a cardiac valve having valve leaflets, said kit comprising:

• an interventional catheter configured to pass from the remote vasculature of a patient to a position within the heart adjacent to the cardiac valve, said catheter having a capture device comprising at least one distal element;
• a fixation tool comprising a penetrating device having a suture and an anchor disposed at the distal end of the suture;
• and
• instructions for use setting forth a method comprising
• accessing a patient's vasculature remote from the heart,
• advancing the interventional tool through the vasculature to a location near the cardiac valve, and
• applying an upward force against a downstream surface of at least one leaflet with the capturing device to reposition at least one leaflet so as to reduce leakage through the valve during ventricular systole.

A kit for repairing a cardiac valve having valve leaflets, said kit comprising:

• an interventional catheter configured to pass from the remote vasculature of a patient to a position within the heart adjacent to the cardiac valve, said catheter having a capture device comprising at least one distal element;
• a fixation tool comprising a penetrating device having a suture and an anchor disposed at the distal end of the suture;
• and
• instructions for use setting forth a method comprising
• accessing a patient's vasculature remote from the heart;
• advancing an interventional tool having a capturing device through the vasculature to a location near the cardiac valve;
• capturing at least one leaflet with the capturing device;
• and
• repositioning the captured leaflets independently of each other.

A kit for repairing a cardiac valve having valve leaflets, said kit comprising:

• an interventional catheter configured to pass from the remote vasculature of a patient to a position within the heart adjacent to the cardiac valve, said catheter having a capture device comprising at least one distal element, wherein the distal element is protrudable radially outward and has a loop shape configured for pressing against a downstream surface of at least one leaflet;
• a fixation tool comprising a penetrating device having a suture and an anchor disposed at the distal end of the suture;
• and
• instructions for use.

A method for repairing a cardiac valve having leaflets, said method comprising:

• accessing a patient's vasculature remote from the heart;
• advancing an interventional tool having a detachable capturing device through the vasculature to a location near the cardiac valve;
• atraumatically capturing the valve leaflets with the capture device;
• and
• detaching the capture device to leave the valve leaflets permanently affixed.

A method for repairing a cardiac valve having valve leaflets, said method comprising:

• accessing a patient's vasculature remote from the heart;
• advancing an interventional tool having a capturing device through the vasculature to a location near the cardiac valve;
• applying an upward force against a downstream surface of at least one leaflet with the capturing device to reposition at least one leaflet so as to reduce leakage through the valve during ventricular systole,
• wherein the interventional tool comprises an elongate shaft having a proximal end and a distal end and the capture device is disposed near the distal end, wherein the capture device comprises at least one distal element capable of protruding radially outward from the shaft and wherein the applying step includes pressing the distal element against the downstream surface of the leaflet;
• and
• adjusting the curvature of the distal element, wherein adjusting the curvature comprises retracting or extending the distal element.

A method for repairing a cardiac valve having valve leaflets, said method comprising:

• accessing a patient's vasculature remote from the heart;
• advancing an interventional tool having a capturing device through the vasculature to a location near the cardiac valve;
• applying an upward force against a downstream surface of at least one leaflet with the capturing device to reposition at least one leaflet so as to reduce leakage through the valve during ventricular systole,
• wherein the interventional tool comprises an elongate shaft having a proximal end and a distal end and the capture device is disposed near the distal end, wherein the capture device comprises at least one distal element capable of protruding radially outward from the shaft and wherein the applying step includes pressing the distal element against the downstream surface of the leaflet, and
• wherein the capture device further comprises at least one proximal element capable of protruding radially outward from the shaft and wherein the method further comprises holding one or more leaflets between the proximal and distal elements;
• and
• adjusting the length of protrusion of the proximal element from the shaft, wherein the adjusting the length step is performed after the applying step which serves to adjust the position of the leaflet.

A method for repairing a cardiac valve having valve leaflets, said method comprising:

• accessing a patient's vasculature remote from the heart;
• advancing an interventional tool having a capturing device through the vasculature to a location near the cardiac valve;
• and
• applying an upward force against a downstream surface of at least one leaflet with the capturing device to reposition at least one leaflet so as to reduce leakage through the valve during ventricular systole,
• wherein the interventional tool comprises an elongate shaft having a proximal end and a distal end and the capture device is disposed near the distal end, wherein the capture device comprises at least one distal element capable of protruding radially outward from the shaft and wherein the applying step includes pressing the distal element against the downstream surface of the leaflet, and
• wherein the capture device further comprises at least one proximal element capable of protruding radially outward from the shaft and wherein the method further comprises holding one or more leaflets between the proximal and distal elements;
• and
• detaching the capture tool from the interventional tool so that the capture tool serves as a fixation device.

A method for repairing a cardiac valve having valve leaflets, said method comprising:

• accessing a patient's vasculature remote from the heart;
• advancing an interventional tool having a capturing device through the vasculature to a location near the cardiac valve;
• capturing at least one leaflet with the capturing device, wherein the capture device comprises at least one proximal element which has at least one friction accessory and at least one distal element, the proximal and distal elements each capable of protruding radially outward from the shaft and wherein the capturing step comprises holding the leaflet between the proximal and distal elements and applying friction to the leaflet with the friction accessory;
• and
• repositioning the captured leaflets independently of each other.

A device for repairing a cardiac valve, said device comprising:

• an interventional catheter configured to pass from the remote vasculature of a patient to a position within the heart adjacent to the cardiac valve;
• and
• a capture device on the interventional catheter comprising at least one distal element, wherein the distal element is protrudable radially outward and has a loop shape configured for pressing against a downstream surface of at least one leaflet,
• wherein the interventional tool further comprises at least one fixation tool for fixing the valve leaflet together, wherein the fixation tool comprises a penetrating device comprising a snare.

A device for repairing a cardiac valve, said device comprising:

• an interventional catheter configured to pass from the remote vasculature of a patient to a position within the heart adjacent to the cardiac valve;
• and
• a capture device on the interventional catheter comprising at least one distal element, wherein the distal element is protrudable radially outward and has a loop shape configured for pressing against a downstream surface of at least one leaflet,
• wherein the interventional tool further comprises at least one fixation tool for fixing the valve leaflet together, wherein the fixation tool comprises a penetrating device which has a slot through which a suture is passable.