METHOD FOR DELIVERING A PROSTHETIC HEART VALVE
First Claim
1. A method of implanting a balloon expandable prosthetic valve within a native aortic valve in a patient, the method comprising:
- introducing a delivery system into a femoral artery of the patient, the delivery system comprising an outer sleeve comprising a selectively steerable distal end portion, the delivery system further comprising a balloon catheter extending through a central lumen in the outer sleeve, wherein a distal end portion of the balloon catheter is positioned distal to a distal end of the steerable distal end portion, and a prosthetic valve is crimped over a balloon disposed along the distal end portion of the balloon catheter;
advancing the prosthetic valve through the femoral artery until the prosthetic valve reaches an aortic arch of the patient;
actuating a pull wire for selectively controlling a curvature of the steerable distal end portion so as to advance the prosthetic valve through the aortic arch, the pull wire having a distal end portion fixedly connected to the steerable distal end portion;
positioning the prosthetic valve at a target site within the native aortic valve; and
radially expanding the prosthetic valve by inflating the balloon.
2 Assignments
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Accused Products
Abstract
An assembly for delivering a prosthetic heart valve to a native heart valve is disclosed. The assembly includes a self-expanding prosthetic heart valve formed with an expandable metallic stent and a flexible valvular structure. The assembly also includes a delivery apparatus having a delivery sleeve. The delivery sleeve includes a selectively steerable section and a distal portion for retaining the prosthetic heart valve in a compressed state. A handle is coupled to a proximal end of the delivery sleeve and a pull wire extends from the handle to the steerable section of the delivery sleeve. The handle preferably includes a rotatable portion for actuating the pull wire and thereby selectively controlling a curvature of the steerable section during advancement through the patient'"'"'s vasculature. In preferred embodiments, the steerable section includes a flexible metallic tubular portion formed with a plurality of circumferentially extending openings.
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Citations
20 Claims
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1. A method of implanting a balloon expandable prosthetic valve within a native aortic valve in a patient, the method comprising:
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introducing a delivery system into a femoral artery of the patient, the delivery system comprising an outer sleeve comprising a selectively steerable distal end portion, the delivery system further comprising a balloon catheter extending through a central lumen in the outer sleeve, wherein a distal end portion of the balloon catheter is positioned distal to a distal end of the steerable distal end portion, and a prosthetic valve is crimped over a balloon disposed along the distal end portion of the balloon catheter; advancing the prosthetic valve through the femoral artery until the prosthetic valve reaches an aortic arch of the patient; actuating a pull wire for selectively controlling a curvature of the steerable distal end portion so as to advance the prosthetic valve through the aortic arch, the pull wire having a distal end portion fixedly connected to the steerable distal end portion; positioning the prosthetic valve at a target site within the native aortic valve; and radially expanding the prosthetic valve by inflating the balloon. - View Dependent Claims (2, 3, 4, 5, 6, 7, 8, 9, 10)
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11. A method of implanting a balloon expandable prosthetic valve within a native aortic valve in a patient, the method comprising:
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introducing a delivery system into a femoral artery of the patient, the delivery system comprising a tubular sleeve and a selectively steerable section fixedly 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, wherein a distal end portion of the balloon catheter is positioned distal to a distal end of the steerable section, and a prosthetic valve is crimped over a balloon disposed along the distal end portion of the balloon catheter; advancing the prosthetic valve, the balloon catheter, and the steerable section through the femoral artery and an aortic arch of the patient; selectively controlling a curvature of the steerable section during advancement around the aortic arch; positioning the prosthetic valve at a target site within the native aortic valve; and inflating the balloon so as to radially expand the prosthetic valve. - View Dependent Claims (12, 13, 14, 15, 16, 17, 18, 19)
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20. A method of implanting a balloon expandable prosthetic valve within a native aortic valve in a patient, the method comprising:
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inserting an introducer into a femoral artery of the patient; inserting a prosthetic valve and a distal end portion of a balloon catheter into a loader, wherein the prosthetic valve is crimped over a balloon disposed along the distal end portion of the balloon catheter, wherein the balloon catheter extends through a central lumen of an outer sleeve comprising a selectively steerable distal end portion, and wherein the distal end portion of the balloon catheter and the prosthetic valve are positioned distal to a distal end of the steerable distal end portion; inserting the loader through a proximal opening of the introducer; pushing the prosthetic valve, the balloon catheter, and the outer sleeve as a single unit outwardly through a distal opening of the loader, into and through the introducer and into the femoral artery; advancing the prosthetic valve through the femoral artery until the prosthetic valve reaches an aortic arch of the patient; actuating a pull wire for selectively controlling a curvature of the steerable distal end portion so as to advance the prosthetic valve through the aortic arch, the pull wire having a distal end portion fixedly connected to the steerable distal end portion at a location proximal to the prosthetic valve such that the prosthetic valve remains straight when the pull wire is actuated to change the curvature of the steerable distal end portion; aligning the prosthetic valve with respect to the native aortic valve by controlling the curvature of the steerable section; advancing the balloon catheter and the prosthetic valve across the native aortic valve; and inflating the balloon so as to radially expand the prosthetic valve.
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Specification