Device and methods for delivery and transfer of temporary radiopaque element
View Patent ↗A device for the transfer of radiopaque material within the body comprises a valvuloplasty or other balloon coated with the radiopaque material. The balloon is inflated in the aortic valve for marking the site of an aortic annulus to enable accurate placement of prosthetic valves under fluoroscopic imaging.
1. A method for marking a valve structure in a heart, said method comprising:
providing an expandable member having a radiopaque material releasably carried on an external surface thereof;
expanding the expandable member within the valve structure in the heart to transfer at least a portion of the radiopaque material to an implantation site in the valve structure prior to implanting a prosthetic valve at the implantation site;
removing the expandable member from the valve structure after the radiopaque material has been transferred to the implantation site; and
fluoroscopically imaging the transferred radiopaque material on the valve structure, wherein the radiopaque material delineates the implantation site on the valve structure prior to implantation of the prosthetic valve.
2. A method as in claim 1 , wherein the valve structure comprises an aortic valve site and the implantation site includes at least one of an aortic root, aortic valve, and aortic valve annulus.
3. A method as in claim 2 , further comprising:
implanting the prosthetic aortic valve at the implantation site.
4. A method as in claim 3 , wherein expanding the expandable member comprises inflating a balloon within the aortic valve site.
5. A method as in claim 4 , wherein said balloon inflation opens the valve leaflets and breaks calcification present on or between the leaflets.
6. A method as in claim 5 , wherein the balloon is inflated to a pressure in the range from 0.1 atmosphere to 20 atmospheres.
7. A method as in claim 1 , wherein the radiopaque material is coated over at least a portion of the surface of the expandable member.
8. A method as in claim 1 , wherein the radiopaque material is disposed in a porous structure of the expandable member.
9. A method as in claim 1 , wherein the radiopaque material is disposed in wells found on the external surface of the expandable member.
10. A method as in claim 1 , wherein the radiopaque material is present on the external surface as a plurality of microdots.
11. A method as in claim 1 , wherein the radiopaque material is present on the external surface under a membrane.
12. A method as in claim 1 , wherein the valve structure comprises mitral valve chordae.
13. A method as in claim 1 , further comprising removing expandable member prior to fluoroscopically imaging the valve structure.
14. A method as in claim 13 , further comprising performing an intervention at the target site while fluoroscopically imaging the valve structure after the expandable member has been removed.
15. A method as in claim 14 , wherein performing an intervention comprises placing a prosthetic valve at the target site.