Methods and devices for capturing and fixing leaflets in valve repair
DCFirst Claim
1. 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, wherein the capture device comprises at least one distal element, wherein each distal element is capable of independently protruding radially outward from the shaft;
capturing at least one leaflet with the capturing device by atraumatically pressing the at least one distal element against the leaflet;
repositioning the captured leaflets independently of each other by applying an upward force against a downstream surface of each leaflet; and
fixing the leaflets together.
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Accused Products
Abstract
The present invention provides methods and devices for grasping, and optional repositioning and fixation of the valve leaflets to treat cardiac valve regurgitation, particularly mitral valve regurgitation. Such grasping will typically be atraumatic providing a number of benefits. For example, atraumatic grasping may allow repositioning of the devices relative to the leaflets and repositioning of the leaflets themselves without damage to the leaflets. However, in some cases it may be necessary or desired to include grasping which pierces or otherwise permanently affects the leaflets. In some of these cases, the grasping step includes fixation.
946 Citations
142 Claims
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1. A method for repairing a cardiac valve having valve leaflets, said method comprising:
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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, wherein the capture device comprises at least one distal element, wherein each distal element is capable of independently protruding radially outward from the shaft;
capturing at least one leaflet with the capturing device by atraumatically pressing the at least one distal element against the leaflet;
repositioning the captured leaflets independently of each other by applying an upward force against a downstream surface of each leaflet; and
fixing the leaflets together. - View Dependent Claims (2, 3, 4, 5, 6, 7)
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8. A method for repairing a cardiac valve having valve leaflets, each leaflet comprising a proximal side and a distal side, said method comprising:
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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. - View Dependent Claims (9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19)
penetrating the first leaflet from the proximal side to the distal side with a penetrating device;
deploying a snare on the distal side of the leaflet so that the snare captures at least part of the first anchor; and
retracting the snare so that the anchor is drawn through the penetration of the snare.
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13. A method as in claim 12, further comprising:
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penetrating the second leaflet from the proximal side to the distal side with a penetrating device;
deploying a snare on the distal side of the leaflet so that the snare captures at least part of the second anchor; and
retracting the snare so that the anchor is drawn through the penetration of the snare.
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14. A method as in claim 8, further comprising:
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penetrating the second leaflet from the proximal side to the distal side with a penetrating device;
deploying a snare on the distal side of the leaflet so that the snare captures at least part of the first anchor; and
retracting the snare so that the anchor is drawn through the penetration of the snare.
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15. A method as in claim 14, further comprising:
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penetrating the first leaflet from the proximal side to the distal side with a penetrating device;
deploying a snare on the distal side of the leaflet so that the snare captures at least part of the second anchor; and
retracting the snare so that the anchor is drawn through the penetration of the snare.
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16. A method as in claim 8, further comprising:
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accessing a patient'"'"'s vasculature remote from the heart;
advancing an interventional tool having at least one guide conduit through the vasculature to a location near the cardiac valve; and
advancing the penetration devices through the guide conduits prior to the penetrating steps.
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17. A method as in claim 16, further comprising extending the guide conduits to desired positions prior to the penetrating steps.
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18. A method as in claim 16, wherein the interventional tool further comprises a capture device comprising at least one loop which is protrudable radially outward from a shaft, the method further comprising:
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protruding the loop(s) radially outward from the shaft;
positioning the guide conduit(s) so that the conduit guides the penetration device through the loop upon advancement of the penetration device; and
advancing the penetration device so that the leaflet is penetrated within the loop.
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19. A method as in claim 18, further comprising retracting one or more loops to radially translate the penetration devices and penetrated leaflets toward the shaft.
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20. A device for repairing a cardiac valve, said device comprising:
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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. - View Dependent Claims (21, 22, 23, 24, 25, 26, 27, 28, 29, 30, 31, 32, 33, 34, 35, 36, 37, 38, 39, 40, 41, 42, 43, 44)
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45. A method for repairing a cardiac valve having valve leaflets, said method comprising:
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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. - View Dependent Claims (46, 47, 48, 49, 50, 51, 52, 53, 54, 55, 56, 57, 58)
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59. A kit for repairing a cardiac valve having valve leaflets, said kit comprising:
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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. - View Dependent Claims (60)
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61. A kit for repairing a cardiac valve having valve leaflets, said kit comprising:
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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. - View Dependent Claims (62)
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63. A kit for repairing a cardiac valve having valve leaflets, said kit comprising:
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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.
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64. A method for repairing a cardiac valve having leaflets, said method comprising:
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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. - View Dependent Claims (65, 66, 67, 68)
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69. A method for repairing a cardiac valve having valve leaflets, said method comprising:
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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. - View Dependent Claims (70, 71, 72, 73, 74, 75, 76, 77, 78, 79, 80, 81, 82)
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83. A method for repairing a cardiac valve having valve leaflets, said method comprising:
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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. - View Dependent Claims (84, 85, 86, 87, 88, 89, 90, 91, 92, 93, 94, 95)
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96. A method for repairing a cardiac valve having valve leaflets, said method comprising:
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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. - View Dependent Claims (97, 98, 99, 100, 101, 102, 103, 104, 105, 106, 107, 108, 109)
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110. A method for repairing a cardiac valve having valve leaflets, said method comprising:
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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.
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111. A device for repairing a cardiac valve, said device comprising:
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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.
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112. A device for repairing a cardiac valve, said device comprising:
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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.
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113. A device for repairing a cardiac valve, said device comprising:
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an interventional catheter comprising at least one guide conduit, the 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. - View Dependent Claims (114, 115, 116, 117, 118, 119, 120, 121, 122, 123, 124, 125, 126, 127, 128, 129)
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130. A device for repairing a cardiac valve, said device comprising:
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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 and wherein the distal element has at least one friction accessory comprising prongs, windings, bands or barbs. - View Dependent Claims (131, 132, 133, 134, 135, 136, 137, 138, 139, 140, 141, 142)
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Specification