Method of delivering a prosthetic heart valve
First Claim
1. A method of deploying a prosthetic valve within a native aortic valve in a human heart, the prosthetic valve comprising a radially compressible and expandable metallic stent and a flexible valvular structure mounted within the stent, the method comprising:
- providing a delivery system comprising a tubular sleeve and a selectively steerable section permanently attached to a distal end of the tubular sleeve, the delivery system further comprising a balloon catheter extending through a central lumen in the tubular sleeve and the steerable section and wherein a distal end portion of the balloon catheter is positioned distal to a distal end of the steerable section;
crimping the prosthetic valve along the distal end portion of the balloon catheter such that the prosthetic valve is positioned distal to the distal end of the steerable section;
advancing the prosthetic valve, balloon catheter, tubular sleeve and steerable section through a femoral artery and an aortic arch;
actuating a pull wire for selectively controlling a curvature of the steerable section during advancement around the aortic arch, the pull wire having a distal end portion permanently fixed to the steerable section;
distally advancing the balloon catheter and prosthetic valve relative to the tubular sleeve and steerable section for positioning the prosthetic valve within the native aortic valve; and
radially expanding the prosthetic valve by inflating a balloon disposed along the distal end portion of the balloon catheter.
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Accused Products
Abstract
A method of delivering a prosthetic heart valve to a native valve site within the human vasculature. The prosthetic valve is disposed on a balloon at the end of a balloon catheter. The balloon catheter passes through a delivery sleeve assembly. A pull wire travels from the handle to a distal end of the delivery sleeve assembly. Actuation of the handle pulls on the pull wire, which causes the delivery sleeve assembly to bend for facilitating navigation through a patient'"'"'s vasculature. A stretchable cover is preferably placed over the slotted tube for biasing the steerable catheter toward a straight position. Once advanced to the vicinity of the native valve site, the prosthetic valve may be accurately positioned by advancing the balloon catheter relative to the delivery sleeve assembly and then deployed within the native valve site by inflating the balloon. In an alternative embodiment, the delivery sleeve assembly may be used to advance a self-expanding prosthetic heart valve through a patient'"'"'s vasculature and a pusher member may be used to eject the prosthetic valve at the native valve site.
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Citations
12 Claims
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1. A method of deploying a prosthetic valve within a native aortic valve in a human heart, the prosthetic valve comprising a radially compressible and expandable metallic stent and a flexible valvular structure mounted within the stent, the method comprising:
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providing a delivery system comprising a tubular sleeve and a selectively steerable section permanently attached to a distal end of the tubular sleeve, the delivery system further comprising a balloon catheter extending through a central lumen in the tubular sleeve and the steerable section and wherein a distal end portion of the balloon catheter is positioned distal to a distal end of the steerable section; crimping the prosthetic valve along the distal end portion of the balloon catheter such that the prosthetic valve is positioned distal to the distal end of the steerable section; advancing the prosthetic valve, balloon catheter, tubular sleeve and steerable section through a femoral artery and an aortic arch; actuating a pull wire for selectively controlling a curvature of the steerable section during advancement around the aortic arch, the pull wire having a distal end portion permanently fixed to the steerable section; distally advancing the balloon catheter and prosthetic valve relative to the tubular sleeve and steerable section for positioning the prosthetic valve within the native aortic valve; and radially expanding the prosthetic valve by inflating a balloon disposed along the distal end portion of the balloon catheter. - View Dependent Claims (2, 3, 4, 5, 6, 7)
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8. A method of deploying a prosthetic valve within a stenotic native aortic valve, the prosthetic valve comprising a radially compressible and expandable metallic stent and a flexible valvular structure mounted within the stent, the method comprising:
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providing a delivery system comprising a tubular sleeve and a selectively steerable section attached to a distal end of the tubular sleeve, the delivery system further comprising a balloon catheter extending through a lumen defined by the tubular sleeve and the steerable section, wherein a distal end portion of the balloon catheter is located distal to a distal end of the steerable section; crimping the prosthetic valve along the distal end portion of the balloon catheter such that the prosthetic valve is positioned distal to the distal end of the steerable section; pre-dilating leaflets of the native aortic valve for increasing the flow area through the native aortic valve; advancing the prosthetic valve, balloon catheter, tubular sleeve and steerable section through a femoral artery and an aortic arch; actuating a pull wire for selectively controlling a curvature of the steerable section during advancement around the aortic arch, the pull wire having a distal end portion fixed to the steerable section; advancing the balloon catheter and prosthetic valve relative to the tubular sleeve and steerable section for positioning the prosthetic valve within the native aortic valve; and radially expanding the prosthetic valve by inflating a balloon disposed along the distal end portion of the balloon catheter. - View Dependent Claims (9, 10, 11, 12)
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Specification