Endovascular flexible stapling device

Abstract

A flexible endovascular stapling device is used for an intravascular procedure to repair a defect, such as a foramen ovale closure. The procedure is designed to avoid open heart surgery by permitting the closure of the defect utilizing a stapling means which is positioned by using a flexible/shaft/guidewire system. Also, in a staple useful for surgical application in a body, there is an improvement wherein the distal portion of a filament having proximal and distal portions is fixedly attached to the staple.

1 . In a staple useful for surgical application in a body, the improvement wherein the distal portion of a filament having proximal and distal portions is fixedly attached to the staple. 
     
     
         2 . A method of effecting intravascular closure comprising;
 advancing a guide wire percutaneously or by incision into a patient's vein;   advancing an introducer over the guide wire where the introducer has distal and proximal ends and the proximal end of the introducer remains outside the patient's body;   advancing a guide wire through the introducer and distally to a position through a defect in the patient's heart septum or other appropriate location;   advancing a flexible stapling device having distal and proximal ends, where said distal end comprises staples and the proximal end comprises actuating means to cause the staples to be fired;   positioning the distal end of the flexible shaft stapling device in proximity to the defect;   activating the actuating means to fire the staples to close at least a portion of the defect; and   withdrawing the flexible stapling device and then the introducer from the patient's vein.   
     
     
         3 . A method of effecting intravascular closure comprising;
 advancing a guide wire percutaneously or by incision into a patient's vein;   advancing an introducer over the guide wire where the introducer has distal and proximal ends and the proximal end of the introducer remains outside the patient's body;   advancing a guide wire through the introducer and distally to a position through a defect in the patient's heart septum or other appropriate location;   advancing a flexible stapling device having distal and proximal, ends, where said distal end comprises staples and a retractable external housing and the proximal end comprises a slide mechanism operably connected to the external housing, said slide mechanism causing the external housing to move from an extended position to a retracted position and causing the staples to he fired in the retracted position;   positioning the distal end of the flexible shaft stapling device in proximity to the defect;   activating the slide mechanism to effect the positioning of the staples located at the distal end of the flexible shaft; and   withdrawing the flexible stapling device and then the introducer from the patient's vein.   
     
     
         4 . A method for closing a patent foramen ovale defect in the heart comprising the steps of:
 introducing a guide wire into a femoral vein to a location in the right atrium of the heart, and through defect to be repaired;   placing a flexible shaft device over the guide wire;   moving the device along the guide wire into a position proximate the detect to he repaired under the guidance of echocardiography; and   activating the flexible shaft device to close at least a portion of the defect,   
     
     
         5 . A method for correcting a defect in the heart by closing said defect, comprising the steps of:
 introducing a guide wire into a femoral vein to a location in the heart and to the defect to be repaired;   placing a flexible shaft device over the guide wire;   moving the device along the guide wire into a position proximate the defect to be repaired under the guidance of echocardiography; and   activating the flexible shaft device to close at least a portion of the defect.   
     
     
         6 . A method of claim  36  wherein the defect to be corrected is chosen from a list comprising: a valvular leak, a patent foramen ovale, an atrial septal defect, a ventricular septal defect, or an annulus of the heart. 
     
     
         7 . A method for closing a cardiac defect, comprising the steps of:
 introducing a guide wire into a patient's femoral artery;   advancing the guide wire through the patient's vasculature to the situs of a cardiac defect to be closed;   mounting a flexible stapling device onto the guide wire and moving the device along the guide wire into a position proximate the cardiac defect to be closed; and   actuating the device such that a staple closes at least a portion of the cardiac defect.