Method and system for balloon counterpulsation during aortic valve replacement

#1. Field of the Invention

#The present invention relates generally to medical devices and methods. More particularly, the present invention relates to a method and system for facilitating percutaneous aortic valve replacement.

#Patients suffering from significant aortic valve disease are frequently treated by aortic valve replacement procedures. While most aortic valve replacements are still performed in open chest procedures, recently there have been significant advances in minimally invasive aortic valve replacement where the valve is introduced through either a transapical approach (minimally invasive) or a transvascular (percutaneous) approach over the aortic arch.

#FIG. 1 is a schematic illustration of a native aortic valve and the surrounding tissue structures including the ascending aortic, the Sinus of Valsalva, and the coronary ostium leading to the coronary arteries.

#FIG. 2 illustrates a system constructed in accordance with the principles of the present invention including a temporary aortic valve (TAV) catheter and system controller.

#FIG. 2A illustrates a multiple-balloon structure present at a distal end of the catheter of the system in FIG. 2 with all balloons inflated.

#A native aortic valve (NAV) is illustrated in FIG. 1. The native aortic valve is positioned just below the ascending aorta (AA) and the Sinus of Valsalva (SV). Coronary ostia (CO) branch off from the Sinus of Valsalva and provide perfusion to coronary arteries which feed the heart muscle (not illustrated). Beneath the native aortic valve is the left ventricle, and the aortic valve is closed during diastole (as shown in full line in FIG. 1) and opens during systole (shown in broken line in FIG. 1) when the left ventricle contracts and ejects blood from the ventricle into the aorta.

#Referring to FIG. 2, a system 10 for regulating aortic regurgitation according to the present invention comprises a temporary aortic valve (TAV), catheter 12 and a controller 14. The catheter 12 has a balloon structure 16 at or near its distal end and an inflation hub 18 at or near its proximal end. In the illustrated embodiment, the balloon structure 16 includes six identical cylindrical balloons disposed coaxially and symmetrically about the body of the catheter 12. FIG. 2A illustrates individual balloons 20 of the balloon structure 16, with all the individual balloons being inflated. FIG. 2B is similar to FIG. 2A, except that only three of the balloons 20a are inflated while three other balloons 20b (only one of which can be seen in FIG. 2B) are deflated.

#The system controller 14 will provide for balloon inflation, typically providing at least one inflation tube or conduit 22 which is connected to the hub 18. Optionally, individual branches of the inflation conduit 22 can be manifolded into a plurality of inflation connectors 24 on the inflation hub 18. It will be appreciated that internal valving within the controller 14 and/or the hub 18 may allow for selective inflation of individual ones and/or individual groups of the balloons 20 of the balloon structure 16.