Methods and devices for capturing and fixing leaflets in valve repair
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.
1. An interventional tool for repairing a cardiac valve of a patient having leaflets, said tool comprising:
a catheter having an inner shaft, a proximal portion and a distal portion adapted for placement through vasculature of the patient to a location near the cardiac valve; and
a capture device detachably connected to the catheter comprising at least two extendable distal elements and at least two extendable proximal elements, each of the proximal and distal elements having a proximal end adjacent the shaft and a distal end, wherein the at least two extendable distal elements and the at least two extendable proximal elements are disposed near the distal portion of said shaft and held in a retracted position adjacent to the shaft, and
wherein the at least two extendable distal elements and the at least two extendable proximal elements are independently deployable and self-expand in an outward radial direction from the shaft to a deployed position further away from the shaft than the retracted position and to positions in between the retracted position and the deployed position, so as to capture the valve leaflets between the at least two extendable distal elements and the at least two extendable proximal elements, wherein extending the at least two distal and at least two proximal elements adjusts a length in each of the elements protruding from the shaft, the length traversing from the distal end of the element to a distal end of the shaft,
wherein the shaft is movable relative to the catheter so that the at least two proximal elements in the deployed position are moved into engagement with the at least two distal elements in the deployed position.
2. A device as in claim 1 , wherein the at least two proximal elements and the at least two distal elements are adapted to atraumatically capture the valve leaflets.
3. A device as in claim 2 , wherein the at least two distal elements and/or the at least two proximal elements further include a frictional accessory.
4. A device as in claim 1 , wherein the at least two proximal elements and/or the at least two distal elements are adapted to be adjusted angularly after capturing the valve leaflets to adjust the position of the leaflets.
5. A device as in claim 1 , wherein the at least two distal elements are disposed on opposite sides of the shaft.
6. A device as in claim 5 , wherein the at least two distal elements are simultaneously deployable.
7. A device as in claim 1 , wherein the at least two proximal elements are disposed on opposite sides of the shaft.
8. A device as in claim 7 , wherein the at least two proximal elements are simultaneously deployable.
9. A device as in claim 1 , wherein the at least two proximal elements and/or the at least two distal elements have a loop shape when deployed.
10. A device as in claim 1 , wherein the at least two proximal elements and/or the at least two distal elements are comprised of stainless steel, metals, nitinol, shape-memory alloy, polymer, silk, polyester, nylon or a combination thereof.
11. A device as in claim 1 , wherein the at least two distal elements and the at least two proximal elements are adapted to fixedly hold the leaflets as captured.
12. A device as in claim 1 , wherein the at least two proximal elements are configured to be disposed within the edges of the corresponding at least two distal elements when both the at least two proximal elements and corresponding at least two distal elements are in a deployed position.
13. A device as in claim 1 , wherein the at least two extendable distal elements and/or the at least two extendable proximal elements are held in the retracted position under tension.
14. A device as in claim 13 , wherein the tension is provided by a strand of material coupled to the at least two extendable distal elements and/or the at least two proximal elements.
15. A device as in claim 14 , wherein the strand of material comprises a suture.
16. A method of repairing a cardiac valve of a patient having leaflets, said method comprising:
providing an interventional tool comprising a catheter having a shaft, a proximal portion, a distal portion and a capture device detachably connected to the catheter, the capture device comprising at least two extendable distal elements and at least two extendable proximal elements, each of the elements having a proximal end adjacent the shaft and a distal end, wherein the at least two extendable distal elements and the at least two extendable proximal elements are disposed near the distal portion of said shaft and held in a retracted position adjacent to the shaft;
advancing the distal portion through the vasculature to a location near the cardiac valve;
deploying the at least two extendable distal elements and the at least two extendable proximal elements so the extendable proximal and distal elements self-expand either independently or together, in an outward radial direction from the shaft to a deployed position further away from the shaft than the retracted position or to positions therebetween so as to capture the valve leaflets;
adjusting a length of the at least two extendable distal elements and the at least two extendable proximal elements protruding from the shaft, wherein the length traverses from the distal end of the element to a distal end of the shaft; and
detaching the capture device from the interventional tool while said shaft is in the vasculature of the patient.
17. A method as in claim 16 , wherein the deploying step comprises advancing the at least two distal elements or the at least two proximal elements outwardly from the shaft.
18. A method as in claim 16 , wherein the deploying step comprises angularly moving the at least two distal elements and/or the at least two proximal elements so that the at least two distal elements and/or the at least two proximal elements form an angle with the shaft.
19. A method as in claim 16 , further comprising angularly adjusting the at least two proximal elements and/or the at least two distal elements after capturing the valve leaflets to adjust the position of the leaflets.
20. A method as in claim 16 , wherein the at least two distal elements are disposed on opposite sides of the shaft.
21. A method as in claim 20 , wherein deploying the at least two distal elements comprises simultaneously deploying the at least two distal elements.
22. A method as in claim 16 , wherein each of the at least two proximal elements are disposed on opposite sides of the shaft.
23. A method as in claim 22 , wherein deploying the at least two proximal elements comprises simultaneously deploying the at least two proximal elements.
24. A method as in claim 16 , further comprising retracting the at least two distal elements and/or the at least two proximal elements.
25. A method as in claim 24 , further comprising repositioning the capture device in relation to the leaflets and redeploying the at least two distal elements and the at least two proximal element so that the valve leaflets are captured therebetween.
26. A method as in claim 16 , further comprising evaluating the cardiac valve for regurgitation while the leaflets are captured.
27. A method as in claim 16 , further comprising fixing the captured leaflets in place.
28. A method as in claim 16 , wherein the at least two extendable distal elements and/or the at least two extendable proximal elements are held in the retracted position under tension.
29. A method as in claim 28 , wherein the step of deploying the at least two extendable distal elements and the at least two proximal elements comprises releasing the tension.
30. A method as in claim 28 , wherein the tension is provided by a strand of material coupled to the at least two extendable distal elements and/or the at least two proximal elements.
31. A method as in claim 30 , wherein the strand of material comprises a suture.