Cardiac devices and methods for percutaneous repair of atrioventricular valves

• US 20040122448A1
• Filed: 08/13/2003
• Published: 06/24/2004
• Est. Priority Date: 08/13/2002
• Status: Active Grant

• Current Assignee: The General Hospital Corporation (Mass General Brigham, Inc.)
• Original Assignee: The General Hospital Corporation (Mass General Brigham, Inc.)
• Inventors: Levine, Robert A.
• Granted Patent: US 7,559,936 B2
• Time in Patent Office: Days
• US Class Current: 606/139
• CPC Class Codes: A61B 17/00234 for minimally invasive surgery A61B17/0218, A61B17/0469, A61B17/12013, A61B17/1285, A61B17/29, A61B17/320016 take precedence
• CPC Class Codes: A61B 17/064 Surgical staples, i.e. penetrating the tissue
• CPC Class Codes: A61B 17/0644 penetrating the tissue, deformable to closed position
• CPC Class Codes: A61B 17/0682 for applying U-shaped staples or clamps, e.g. without a forming anvil
• CPC Class Codes: A61B 2017/00243 cardiac
• CPC Class Codes: A61B 2017/00783 Valvuloplasty
• CPC Class Codes: A61B 2017/00867 shape memory effect
• CPC Class Codes: A61B 2017/306 holding by means of suction

Abstract

Novel apparatus and minimally invasive methods to treat The present invention provides methods and devices for grasping, stabilizing an d fastening of cardiac valve leaflets to treat atrioventricular valve regurgitation, particularly mitral valve regurgitation, in the context of prolapse and/or flail mitral valve. Independent leaflet grasping elements provide the ability to reposition the leaflets for fastening and enough stability to prevent leaflet movement during fastening.

Claims

1. A device for repairing a cardiac valve, comprising:

a catheter assembly configured to pass from the remote vasculature of a patient to a position within the heart adjacent the cardiac valve;

a pair of maneuverable grasping elements independently translatable through the catheter assembly, the grasping elements reversibly and radially extendable from the catheter assembly to capture and reposition portions of two valve leaflets into an apposed position; and

fastening mechanism translatable through the catheter assembly to secure the stabilized portions of the two valve leaflets.

2. The device of claim 1, wherein the catheter assembly comprises a single catheter having a curved distal end so as to enable valve access retrograde via the aorta.

3. The device of claim 2, wherein the distal end is composed at least in part of a shape memory material.

4. The device of claim 1, wherein the catheter assembly is comprised of a pair of slidably linked catheters, one of the grasping elements disposed in each catheter, and wherein each catheter includes at least one side port through which the fastening mechanism is extendable and disengagable from the catheter assembly.

5. The device of claim 1, wherein the fastening mechanism is radially extendable and disengagable from the catheter assembly through at least one side port of the catheter assembly.

6. The device of claim 5, wherein the fastening mechanism comprises a staple or rivet insertable through each of the captured leaflet portions without displacing the leaflets.

7. The device of claim 5, wherein the fastening mechanism is composed at least in part of a shape memory material.

8. The device of claim 5, further comprising a rectractable portion of the catheter assembly proximate the at least one side port, in its retracted state creating a notch in the catheter assembly through which the fastening mechanism is disengagable from the catheter assembly.

9. The device of claim 1, wherein each of the grasping elements extends from the distal end of the catheter assembly with reverse deformation so as to clip a ventricular surface of one of the valve leaflets.

10. The device of claim 9, further comprising:

a pair of steerable grasping elements independently translatable through the catheter assembly, each grasping element reversibly and radially extendable from one of at least two opposed side ports in the catheter assembly with an adjustable deformation so as to grasp an atrial surface of one of the valve leaflets.

11. The device of claim 1, wherein each of the grasping elements extends from one of at least two opposed side ports in the catheter assembly with a deformation so as to clip a ventricular surface of one of the valve leaflets.

12. The device of claim 1, wherein each of the grasping elements extends from one of at least two opposed side ports in the catheter assembly with an adjustable deformation so as to grasp an atrial surface of the valve leaflets.

13. The device of claim 12, wherein a pair of operable jaws are disposed on each distal end of the grasping elements.

14. The device of claim 12, wherein a suction assembly is disposed on each distal end of the grasping elements.

15. The device of claim 1, wherein the grasping elements are composed at least in part of shape memory material.

16. The device of claim 1, further comprising an introducer catheter for advancing the catheter assembly toward the cardiac valve.

17. The device of claim 16, wherein the introducer catheter further comprises a directing arm through which the catheter assembly is maneuverable to a position proximate the cardiac valve.

18. The device of claim 16, wherein the introducer catheter further comprises a means for temporarily stabilizing the position of the introducer catheter within the left ventricle.

19. The device of claim 18, wherein the stabilization means comprises one or more contact elements reversibly extendable from the introducer catheter so as to contact an internal surface of the heart cavity at one or more points.

20. The device of claim 19, wherein the one or more contact elements are composed of shape memory elastic material.

21. The device of claim 1, further comprising an imaging device oriented so as to image a region near the cardiac valve.

22. The device of claim 1, further comprising:

a capture triggering mechanism including one or more sensors for detecting the position of the valve leaflets with respect to the grasping elements, wherein the grasping elements extend in response to an indication that the leaflets are within a predetermined distance from the grasping elements.

23. A method for repairing a cardiac valve, comprising the steps of:

advancing a catheter assembly from the remote vasculature of a patient to a position within the heart adjacent the cardiac valve;

independently capturing and stabilizing in an apposed position two valve leaflets via a pair of grasping elements translated through the catheter assembly;

fastening the two valve leaflets at one or more points; and

disengaging the catheter assembly from the valve leaflets.

24. The method of claim 23, wherein the catheter assembly is advanced via a pathway selected from the group consisting of:

retrograde via the aterial system into the left ventricle, through the venous system and right atrium into the left atrium across the atrial septum, directly through a wall of the heart, and percutaneously through a small incision in the chest wall and pericardium.

25. The method of claim 23, wherein the capturing step further comprises the steps of:

positioning each grasping element composed at least in part of shape memory material proximate the cardiac valve; and

reversibly extruding the grasping elements from the catheter assembly, each grasping element reversibly and radially extending from the catheter assembly so as to clip a portion of one of the valve leaflets.

26. The method of claim 25, wherein the capturing step further comprises the steps of:

positioning each grasping element proximate the cardiac valve;

reversibly and radially extending each of the grasping elements through one of at least two opposed side ports in the catheter assembly;

steering each grasping element to a position proximate an atrial surface of one of the valve leaflets; and

grasping the atrial surface.

27. The method of claim 23, further comprising the step of temporarily stabilizing the position of the catheter assembly within the heart.

28. The method of claim 23, further comprising the step of imaging a region near the cardiac valve during the repair method.

29. The method of claim 28, wherein the imaging comprises transducing ultrasound energy to the region.

30. The method of claim 29, wherein the ultrasound energy is transduced from the chest surface, esophagus, or within the heart.

31. The method of claim 29, wherein the ultrasound energy transduced from within the heart is provided by an ultrasound transducer positioned proximate the cardiac valve.

32. The method of claim 23, further comprising the step of:

triggering the independent capturing of each leaflet based on sensor output indicating leaflet position.