Devices and methods for effectuating percutaneous glenn and fontan procedures
In some implementations, a radially self-expanding endograft prosthesis is provided that includes (i) distal flange that is self-expanding and configured to flip generally perpendicularly with respect to a body of the prosthesis to help seat the prosthesis against a tissue wall, (ii) a distal segment extending proximally from the distal flange that has sufficient stiffness to maintain a puncture open that is formed through a vessel wall (iii) a compliant middle segment extending proximally from the distal segment, the middle segment being more compliant than the distal segment, and having independently movable undulating strut rings attached to a tubular fabric, the combined structure providing flexibility and compliance to allow for full patency while flexed, the segment being configured to accommodate up to a 90 degree bend, (iv) a proximal segment having a plurality of adjacent undulating strut rings that are connected to each other.
1. A method of installing a tubular prosthesis through a sidewall of a native lumenal vessel, comprising:
providing a prosthesis having:
a distal annular flange configured to help seat the prosthesis when it is pulled proximally;
a distal tubular segment extending proximally from the distal flange that has sufficient stiffness to maintain a puncture in an open condition that is formed through a first vessel wall through which the distal segment passes;
a proximal tubular segment that is sufficiently stiff to seat within and urge against a second vessel wall; and
collapsing the prosthesis onto a delivery system;
delivering a distal end of the delivery system to an opening defined through a native lumenal vessel wall; and
deploying the distal annular flange inside of the native luminal vessel wall; further comprising de-tensioning a tether directed through a proximal end of the prosthesis to open the proximal end of the prosthesis;
wherein both ends of the tether are directed proximally through and out of a proximal region of the delivery system, and further wherein tension is applied from outside a patient being treated.
2. The method of claim 1 , further comprising pulling proximally on the delivery system to seat the distal annular flange.
3. The method of claim 2 , further comprising deploying the distal tubular segment from the delivery system.
4. The method of claim 3 , further comprising deploying the proximal tubular segment from the delivery system.
5. The method of claim 4 , wherein the proximal tubular segment is deployed inside of a second lumenal vessel.
6. The method of claim 5 , wherein the prosthesis further includes a proximal annular flange coupled to the proximal tubular segment, and further wherein the method further comprises deploying the proximal annular flange inside of the second lumenal vessel against an inner wall of the second lumenal vessel.
7. The method of claim 5 , wherein the proximal tubular segment is deployed in a second lumenal vessel and further wherein the proximal tubular segment is urged against an inner wall of the second lumenal vessel.
8. The method of claim 1 , further comprising pulling on one end of the tether to remove the tether from the implant.
9. The method of claim 1 , further comprising re-tensioning the tether to cause the proximal end of the prosthesis to collapse radially inwardly.
10. The method of claim 9 , further comprising withdrawing the prosthesis into a sheath of the delivery system.
11. The method of claim 1 , wherein the prosthesis further includes a first set of radiopaque markers near a distal end of the delivery system, and a second set of markers that are visible outside a patient that indicates the relative position of the delivery system and prosthesis, and further wherein the method includes maintaining the first and second set of markers in registration with each other during the procedure.
12. The method of claim 11 , wherein the first set of markers is located on a distal atraumatic tip of the delivery system are visible under MRI, and further wherein the procedure is conducted while imaging using a MRI imaging modality in real time.
13. The method of claim 1 , wherein the prosthesis includes distal markers proximate the distal flange, and further wherein the method includes observing when the distal markers are aligned with the opening in the native lumenal vessel wall.
14. The method of claim 1 , wherein the prosthesis further includes a flared or bell-shaped proximal region, and further wherein the method includes deploying the flared or bell shaped proximal region against the interior wall of a lumen.
15. The method of claim 1 , wherein the prosthesis further defines at least one fenestration through a sidewall thereof and further wherein the method includes positioning the prosthesis in a manner that permits leakage of bodily fluid through the fenestration.
16. The method of claim 1 , wherein the prosthesis can be adjusted in length, and further wherein the method includes adjusting the prosthesis in length when installing the prosthesis.