METHODS OF IMPLANTING MINIMALLY-INVASIVE PROSTHETIC HEART VALVES
First Claim
1. A method for replacing a damaged or diseased aortic valve, the method comprising:
- advancing a delivery cannula over a guidewire into a patient through an access port in a chest of the patient, a self-expanding prosthetic heart valve in a radially compressed state loaded within the delivery cannula, the prosthetic valve comprising;
a collapsible, self-expanding support stent comprising nitinol, the support stent including a generally tubular base along an inflow end and three commissure posts provided along an outflow end and extending in an outflow direction, the commissure posts being spaced in 120 degree intervals with gaps therebetween, the tubular base comprising a mesh or web;
a fabric section connected to the base along the inflow end of the support stent, the fabric section made from a polyester material; and
a leaflet section directly attached to the fabric section at a seam, the leaflet section defining three leaflets formed of bovine pericardium, the three leaflets attached to the commissure posts for opening and closing;
wherein each commissure post has a slot formed therein and wherein portions of the leaflet section pass through the slot in each of the commissure posts for securement to an outside thereof, andwherein the portions of the leaflet section form loops and wherein inserts are disposed within the loops on the outside of each commissure post, the inserts each having a greater width than a circumferential width of the slots to prevent the loops from pulling inward through the slots;
positioning the delivery cannula with the prosthetic heart valve within an annulus of a native aortic valve;
releasing the prosthetic heart valve from the delivery cannula within the annulus of the native aortic valve;
allowing the prosthetic heart valve to self-expand within the annulus of the native aortic valve such that the tubular base of the support stent of the prosthetic heart valve expands to engage the annulus and the three leaflets of the prosthetic heart valve are disposed downstream of the annulus; and
removing the delivery cannula and guidewire from the patient.
1 Assignment
0 Petitions
Accused Products
Abstract
Expandable prosthetic heart valves for minimally invasive valve replacement are disclosed. In one preferred embodiment, an expandable prosthetic heart valve includes a support stent comprising an expandable tubular base along an inflow end and three upstanding commissure posts along an outflow end. The three commissure posts are spaced at 120 degree intervals with gaps therebetween. The prosthetic heart valve further includes a tubular flexible member having a prosthetic section and a fabric section. The prosthetic section is connected to the three commissure posts and defines three leaflets, preferably formed of pericardial tissue. The fabric section is sutured to the expandable tubular base. The tubular base may be formed with a shape memory material and is sized for deployment with an annulus of a native aortic valve. After deployment, the three commissure posts support the leaflets above the tubular base for replacing the function of the native aortic valve. In one variation, flanges may be provided on the support stent for improving attachment of the support stent to the host tissue.
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Citations
20 Claims
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1. A method for replacing a damaged or diseased aortic valve, the method comprising:
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advancing a delivery cannula over a guidewire into a patient through an access port in a chest of the patient, a self-expanding prosthetic heart valve in a radially compressed state loaded within the delivery cannula, the prosthetic valve comprising; a collapsible, self-expanding support stent comprising nitinol, the support stent including a generally tubular base along an inflow end and three commissure posts provided along an outflow end and extending in an outflow direction, the commissure posts being spaced in 120 degree intervals with gaps therebetween, the tubular base comprising a mesh or web; a fabric section connected to the base along the inflow end of the support stent, the fabric section made from a polyester material; and a leaflet section directly attached to the fabric section at a seam, the leaflet section defining three leaflets formed of bovine pericardium, the three leaflets attached to the commissure posts for opening and closing; wherein each commissure post has a slot formed therein and wherein portions of the leaflet section pass through the slot in each of the commissure posts for securement to an outside thereof, and wherein the portions of the leaflet section form loops and wherein inserts are disposed within the loops on the outside of each commissure post, the inserts each having a greater width than a circumferential width of the slots to prevent the loops from pulling inward through the slots; positioning the delivery cannula with the prosthetic heart valve within an annulus of a native aortic valve; releasing the prosthetic heart valve from the delivery cannula within the annulus of the native aortic valve; allowing the prosthetic heart valve to self-expand within the annulus of the native aortic valve such that the tubular base of the support stent of the prosthetic heart valve expands to engage the annulus and the three leaflets of the prosthetic heart valve are disposed downstream of the annulus; and removing the delivery cannula and guidewire from the patient. - View Dependent Claims (2, 3, 4, 5, 6)
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7. A method for replacing a damaged or diseased aortic valve, the method comprising:
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minimally invasively advancing a delivery cannula into a patient, a self-expanding prosthetic heart valve in a radially compressed state loaded within the delivery cannula, the prosthetic valve comprising; a collapsible, self-expanding support stent comprising a shape memory material, the support stent including a generally tubular base along an inflow end and three commissure posts provided along an outflow end and extending in an outflow direction, the three commissure posts being cantilevered from the base, each commissure post having a slot formed therein; and a flexible tubular member attached to the support stent, the flexible tubular member comprising a fabric section connected to the base along the inflow end of the support stent and a leaflet section defining three leaflets connected to the commissure posts along the outflow end of the support stent, wherein portions of the leaflet section extend outward through the slots in the commissure posts for securing the leaflet section to the commissure posts; wherein the leaflet section forms loops that pass through each of the commissure posts slots and the prosthetic heart valve further includes inserts disposed within the loops on an outside region of each commissure post, the inserts each having a greater width than a circumferential width of the slots to prevent the loops from pulling inward through the slots; positioning the delivery cannula with the prosthetic heart valve within an annulus of a native aortic valve; releasing the prosthetic heart valve from the delivery cannula within the annulus of the native aortic valve; allowing the prosthetic heart valve to self-expand within the annulus of the native aortic valve such that the tubular base of the support stent of the prosthetic heart valve expands to engage the annulus and the three leaflets of the prosthetic heart valve are disposed downstream of the annulus; and removing the delivery cannula from the patient. - View Dependent Claims (8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20)
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Specification