Two-step heart valve implantation
First Claim
1. A method of treating a defective native aortic valve in a human heart, comprising:
- creating an incision in a chest wall of a patient and accessing the native aortic valve through an apex of the heart;
advancing a balloon through the incision in the chest wall and inflating the balloon within the native aortic valve;
advancing a first percutaneously implantable heart valve in a crimped state through the incision in the chest wall and apex of the heart, the first percutaneously implantable heart valve comprising a radially-expandable first stent supporting a radially-expandable temporary valve within an interior portion of the first stent;
positioning the first stent within the native aortic valve;
expanding the first stent to an operational diameter within the native aortic valve, compressing the native leaflets, so that the temporary valve becomes operational;
while the incision in the chest wall remains open, advancing a second percutaneously implantable heart valve in a crimped state through the incision in the chest wall and apex of the heart, the second percutaneously implantable heart valve comprising a radially-expandable second stent supporting a radially-expandable replacement valve within an interior portion of the second stent;
positioning the radially-expandable second stent within the operational temporary valve of the expanded first stent; and
expanding the radially-expandable second stent so as to compress the temporary valve between the first stent and the second stent while maintaining the first stent at the operational diameter;
wherein, after expansion of the second stent, the replacement valve becomes operational for replacing the function of the defective native aortic valve.
1 Assignment
0 Petitions
Accused Products
Abstract
A two-part implantable heart valve and procedure are disclosed that allow expansion and positioning of a first part of the implantable heart valve having a temporary or transient valvular structure. A second part of the implantable heart valve is deployed within the first part and attaches thereto. The valvular structure of the second part then acts to function as the heart valve replacement. A tool or system is provided for determining an adequate percutaneous heart valve size for a given stenotic valve. A balloon can be inflated inside the stenotic valve to a desired pressure. When this pressure is reached an angiographic image is taken and the balloon diameter is measured at a waist area created by contact between the balloon and the stenotic valve. The diameter represents the minimum percutaneous heart valve diameter to be implanted.
274 Citations
22 Claims
-
1. A method of treating a defective native aortic valve in a human heart, comprising:
-
creating an incision in a chest wall of a patient and accessing the native aortic valve through an apex of the heart; advancing a balloon through the incision in the chest wall and inflating the balloon within the native aortic valve; advancing a first percutaneously implantable heart valve in a crimped state through the incision in the chest wall and apex of the heart, the first percutaneously implantable heart valve comprising a radially-expandable first stent supporting a radially-expandable temporary valve within an interior portion of the first stent; positioning the first stent within the native aortic valve; expanding the first stent to an operational diameter within the native aortic valve, compressing the native leaflets, so that the temporary valve becomes operational; while the incision in the chest wall remains open, advancing a second percutaneously implantable heart valve in a crimped state through the incision in the chest wall and apex of the heart, the second percutaneously implantable heart valve comprising a radially-expandable second stent supporting a radially-expandable replacement valve within an interior portion of the second stent; positioning the radially-expandable second stent within the operational temporary valve of the expanded first stent; and expanding the radially-expandable second stent so as to compress the temporary valve between the first stent and the second stent while maintaining the first stent at the operational diameter; wherein, after expansion of the second stent, the replacement valve becomes operational for replacing the function of the defective native aortic valve. - View Dependent Claims (2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12)
-
-
13. A method of implanting a prosthetic cardiac valve within a native heart valve, comprising:
-
deploying a temporary valve and expanding a radially-expandable first stent in the native heart valve so that the first stent has a first diameter in which the temporary valve is operational; and during the same implantation procedure deploying a replacement valve and a second stent by inserting the replacement valve and the second stent into the operational temporary valve and by expanding the replacement valve and second stent so as to compress the temporary valve between the first and second stents, while maintaining the first stent at the first diameter; wherein the first and second stents are advanced using a common delivery catheter having first and second balloons coupled in series. - View Dependent Claims (14, 15, 16, 17, 18, 19, 20, 21, 22)
-
Specification