초록 ▼

The invention is an annuloplasty ring, and associated methods therefore, configured to reshape a native heart valve annulus to correct heart valve function, and also configured to be reshaped into a generally circular form in order to receive and/or support a prosthetic heart valve. The annuloplasty

The invention is an annuloplasty ring, and associated methods therefore, configured to reshape a native heart valve annulus to correct heart valve function, and also configured to be reshaped into a generally circular form in order to receive and/or support a prosthetic heart valve. The annuloplasty ring may be configured to have a generally D-shaped configuration when initially implanted to correct native valve function, but to assume a generally circular form when subjected to an outward force such as that provided by a dilation balloon.

대표청구항 ▼

1. A method of repairing a patient's heart function, comprising: providing an annuloplasty ring having a first configuration having a first inner area but configured to assume a second configuration having a second inner area when subjected to a dilatational force, wherein in the first configuration

1. A method of repairing a patient's heart function, comprising: providing an annuloplasty ring having a first configuration having a first inner area but configured to assume a second configuration having a second inner area when subjected to a dilatational force, wherein in the first configuration the annuloplasty ring has a generally non-circular shape, in the second configuration the annuloplasty ring has a generally circular shape, and the second inner area is greater than the first inner area; andrestoring the functionality of a native heart valve by implanting the annuloplasty ring in a heart valve annulus of the native heart valve, wherein the annuloplasty ring is implanted in the first configuration and the shape of the heart valve annulus is thereby remodeled to provide proper alignment and closure of the native heart valve leaflets;and deploying an expandable prosthetic heart valve within the annuloplasty ring and heart valve annulus;wherein deploying the expandable prosthetic heart valve within the annuloplasty ring and heart valve annulus further comprises: dilating the annuloplasty ring to transform the annuloplasty ring from the first configuration to the second configuration, to dilate the heart valve annulus. 2. The method of claim 1, wherein the step of dilating the annuloplasty ring further comprises crushing the native leaflets against the heart valve annulus. 3. The method of claim 1, comprising, prior to the step of deploying the expandable prosthetic heart valve, the further steps of: providing the expandable prosthetic heart valve on an inflatable balloon of a dilation catheter; andadvancing the inflatable balloon with expandable prosthetic heart valve thereon into the heart valve annulus;wherein deploying the expandable prosthetic heart valve comprises inflating the inflatable balloon to a pressure sufficient to dilate the annuloplasty ring from the first configuration to the second configuration, to dilate the heart valve annulus, to crush the native valve leaflets against the heart valve annulus, and to expand the expandable prosthetic heart valve. 4. The method of claim 3, wherein inflating the inflatable balloon to a pressure sufficient to dilate the annuloplasty ring comprises inflating the balloon to a pressure of no more than 6 atmospheres. 5. The method of claim 4, wherein inflating the inflatable balloon to a pressure sufficient to dilate the annuloplasty ring comprises inflating the balloon to a pressure of no more than 4 atmospheres. 6. The method of claim 1, further comprising: dilating the annuloplasty ring to transform the annuloplasty ring from the first configuration to the second configuration and to dilate the heart valve annulus. 7. The method of claim 6, wherein dilating the annuloplasty ring further comprises crushing the native leaflets against the heart valve annulus. 8. The method of claim 6, wherein dilating the annuloplasty ring comprises expanding an inflatable balloon to a pressure of no more than 6 atmospheres. 9. A method for modifying a native heart valve, comprising: providing an annuloplasty ring having a first substantially rigid configuration having a substantially non-circular shape and a second substantially non-rigid configuration having a substantially circular shape;repairing the functionality of the native heart valve by implanting the annuloplasty ring into a valve annulus of the native heart valve with the annuloplasty ring in the first substantially rigid configuration, wherein after implantation the annuloplasty ring is in the first generally rigid configuration and whereby the shape of the heart valve annulus is thereby remodeled to provide proper alignment and closure of the native heart valve leaflets;and after repairing the functionality of the native heart valve, dilating the annuloplasty ring and valve annulus and crushing the native heart valve leaflets against the valve annulus;wherein dilating the annuloplasty ring and valve annulus and crushing the native heart valve leaflets against the valve annulus comprises deploying an expandable prosthetic valve within the valve annulus. 10. The method of claim 9, wherein dilating the annuloplasty ring comprises transforming the annuloplasty ring from the first substantially rigid configuration to the second substantially non-rigid configuration. 11. The method of claim 9, wherein the expandable prosthetic valve is a balloon-expandable prosthetic valve mounted on an expandable balloon, and wherein dilating the expandable prosthetic valve within the valve annulus comprises inflating the expandable balloon within the valve annulus to dilate the expandable prosthetic valve while simultaneously dilating the annuloplasty ring and transforming the annuloplasty ring from the first substantially rigid configuration to the second substantially non-rigid configuration. 12. The method of claim 11, wherein repairing the functionality of the native heart valve by implanting the annuloplasty ring into a valve annulus of the native heart valve comprises implanting the annuloplasty ring using an open chest surgical or keyhole minimally-invasive procedure, and wherein dilating the annuloplasty ring and valve annulus and crushing the native heart valve leaflets against the valve annulus comprises advancing the expandable balloon into the valve annulus via a percutaneous route. 13. The method of claim 9, wherein repairing the functionality of the native heart valve by implanting the annuloplasty ring into a valve annulus of a native heart valve comprises implanting the annuloplasty ring using an open chest surgical or keyhole minimally-invasive procedure. 14. A method of repairing a human heart in the body of a patient, comprising: repairing functionality of a native mitral valve by surgically implanting a substantially D-shaped annuloplasty ring within the valve annulus of the native mitral valve to thereby remodel the valve annulus to a desired substantially non-circular configuration to provide proper alignment and closure of the native heart valve leaflets; andafter repairing functionality of the native mitral valve by surgically implanting the substantially D-shaped annuloplasty ring, dilating the native mitral valve to permanently permanently transform the annuloplasty ring into a substantially circular shape and substantially non-rigid configuration and to remodel the valve annulus into a substantially circular configuration;and implanting an expandable prosthetic heart valve within the valve annulus. 15. The method of claim 14, further comprising: advancing a dilation balloon into the native mitral valve;and wherein dilating the native mitral valve comprises inflating the dilation balloon to a pressure of 1 to 6 atmospheres. 16. The method of claim 15, wherein the expandable prosthetic heart valve is positioned on the dilation balloon, wherein dilating the native mitral valve further comprises deploying the expandable prosthetic heart valve within the valve annulus. 17. The method of claim 16, wherein advancing the dilation balloon comprises advancing the dilation balloon to the native mitral via the femoral artery in a percutaneous approach, the method further comprising: after dilating the native mitral valve, removing the dilation balloon from the body of the patient, whereby the expandable prosthetic heart valve remains within the valve annulus and the valve annulus remains in the substantially circular configuration. 18. The method of claim 14, wherein the valve annulus has a pre-dilation inner orifice area and a post-dilation inner orifice area, and wherein dilating the native mitral valve comprises remodeling the valve annulus into a substantially circular configuration wherein the post-dilation inner orifice area is at least 15% larger than the pre-dilation inner orifice area.