Devices and methods for percutaneous mitral valve repair
First Claim
1. A method of repairing a mitral valve in the heart of a patient, such method comprising the steps of:
- inserting a catheter through the atrium to the mitral valve, the catheter having a distal end and a proximal end;
gripping opposed leaflets of the mitral valve with the distal end of the catheter so as to effectively juxtapose the opposed leaflets at a point thereof; and
fastening the opposed leaflets at said point.
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Abstract
Devices and methods are provided for diagnosing and repairing mitral valve defects such as mitral valve regurgitation. According to an exemplary method, mitral valve function is visualized by transesophageal echocardiography. A catheter is inserted along the venous system of the patient through the atrium into the mitral valve. A suction tip grasps the leaflets of the mitral valve to immobilize and juxtapose the leaflets at a point simulating a stitch, and the mitral valve is again observed to confirm that fastening at that point will repair the prolapse or other defect. The mitral valve leaflets are then via a fastening such as a staple or shape memory rivet. The fastener may be inserted by a stapling assembly in the venous catheter tip, or by a separate stapler that is inserted along an arterial path from the opposite direction and guided along a transcardiac rail to the immobilized point. Upon completion of the repair process, the mitral valve is once again visualized by transesophageal echocardiography to determine whether repair thereof has been effected.
228 Citations
28 Claims
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1. A method of repairing a mitral valve in the heart of a patient, such method comprising the steps of:
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inserting a catheter through the atrium to the mitral valve, the catheter having a distal end and a proximal end;
gripping opposed leaflets of the mitral valve with the distal end of the catheter so as to effectively juxtapose the opposed leaflets at a point thereof; and
fastening the opposed leaflets at said point. - View Dependent Claims (2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 19)
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18. A method of repairing a mitral valve in the heart of a patient, such method comprising the steps of:
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inserting a catheter along the venous system of the patient to approach the mitral valve through the atrium;
applying suction at a distal end of the catheter to draw opposed leaflets of the mitral valve into contact;
extending a guide wire from the catheter into the ventricle and along the arterial system of the patient; and
guiding a stapling device along said guide wire to the opposed leaflets to staple the opposed leaflets together while the heart is beating.
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20. A method of repairing a mitral valve in the heart of a patient, such method comprising the steps of:
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inserting a catheter along the venous system of the patient to approach the mitral valve through the atrium, the catheter having a distal end and a proximal end, the catheter containing a fastener, and the catheter also having a balloon, a fluid inflation line, and a plunger device attached thereto;
applying suction at the distal end of the catheter to draw opposed leaflets of the mitral valve into contact;
inflating the balloon via the fluid inflation line;
using the plunger to move the fastener distally out of the catheter; and
causing the fastener to curl around the inflated balloon such that is ends penetrate and fasten together the opposed leaflets.
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21. A diagnostic method for repair of a mitral valve defect, such method comprising the steps of:
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visualizing mitral valve function by transesophageal echocardiography;
inserting a catheter along the venous system of the patient to the mitral valve;
applying suction at the tip of the catheter to draw opposed leaflets of the valve together at a selected point;
visualizing mitral valve function by transesophageal echocardiography to confirm the efficacy of fastening the selected point to repair the defect; and
fastening the opposed leaflets at said point.
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22. An endovascular device for cardiac treatment, such device comprising:
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an elongated catheter body adapted for percutaneous insertion along the venous system of a patient to the heart; and
a suction assembly disposed at a distal end of said catheter body, the suction assembly being effective to define negative flow into said catheter body along opposed sides thereof, whereby insertion of the catheter into the atrium with the distal end of the catheter positioned in the mitral valve is effective to draw opposed leaflets of said mitral valve together in juxtaposition for simulating an Alfieri leaflet stitch repair. - View Dependent Claims (23, 24, 25, 26, 28)
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27. A method of repairing a mitral valve, such method comprising the steps of:
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immobilizing opposed leaflets of the mitral valve with an endovascular catheter assembly inserted from a first direction; and
stapling the immobilized leaflets with a stapling device inserted from a direction opposite to said first direction.
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Specification