Anastomotic devices and methods
View Patent ↗Exemplary embodiments comprise AV fistulas and other anastomotic devices for creating new or reinforcing existing side-branch vessels, and/or bridging neighboring vessels together. An exemplary embodiment may comprise a sidewall port, such as a flanged sidewall port, and/or flow frame design, such as a partially bare, flexible stent or a whisk, for purposes of creating a transmural flow. Another exemplary embodiment may comprise a compliant vessel support to aid in the transition from device to vessel and/or vessel to device, and to promote vessel dilation.
1. A fistula device comprising:
a generally continuous conduit configured to transport a fluid without leakage between a first vessel and a second vessel and having a proximal portion and a distal portion;
a sidewall port device connected to the conduit and locatable in the proximal portion wherein the sidewall port device is configured to engage a first vessel wall about an aperture in the first vessel wall and form a seal with the first vessel wall when deployed, the sidewall port device comprising a lattice inverted onto itself to form an inner tube disposed coaxially within an outer tube; and
a compliant support locatable on the distal portion and configured to expand outwardly toward inner walls of the second vessel when deployed,
wherein the compliant support is sufficiently flexible and compliant to minimize radial distension of the second vessel after deployment.
2. The fistula device as set forth in claim 1 , wherein the first vessel is an artery and the second vessel is a vein.
3. The fistula device as set forth in claim 1 , wherein the sidewall port device comprises a first flange that extends radially with respect to the aperture.
4. The fistula device as set forth in claim 3 , wherein the sidewall port device further comprises a second flange that extends radially with respect to the aperture, the second flange being axially spaced apart from the first flange to receive a portion of the first vessel wall therebetween, the first and second flanges configured to mechanically engage opposite surfaces of the first vessel wall.
5. The fistula device as set forth in claim 4 , wherein the first and second flanges include a lattice that radially outwardly biases the flanges toward an outer peripheral dimension that is larger than that of the conduit.
6. The fistula device as set forth in claim 5 , wherein the lattice is formed from Nitinol.
7. The fistula device as set forth in claim 5 , wherein the lattice is substantially covered by an ePTFE film.
8. The fistula device as set forth in claim 1 , wherein the sidewall port device includes a plurality of outwardly extending anchors configured to engage an inner surface of the first vessel wall to secure the sidewall port device to the first vessel about the aperture.
9. The fistula device as set forth in claim 1 , wherein the compliant support in an uncompressed state has an outer diameter that is larger than that of the distal portion of the conduit.
10. The fistula device as set forth in claim 1 , wherein the compliant support comprises a wire frame made from Nitinol.
11. The fistula device as set forth in claim 1 , wherein the compliant support is fixedly secured to the conduit by an annular band.
12. The fistula device as set forth in claim 11 , wherein the annular band is formed from an ePTFE film.
13. The fistula device as set forth in claim 11 , wherein the compliant support is spaced apart from the conduit and coupled thereto solely by the annular band.
14. The fistula device as set forth in claim 1 , further comprising a compressed configuration and an expanded configuration.
15. The fistula device as set forth in claim 14 , wherein the device is percutaneously deployable.
16. A fistula device comprising:
a generally continuous conduit to allow flow between a first vessel and a second vessel and having a proximal portion and a distal portion;
a sidewall port device connected to the conduit and locatable in the proximal portion, the sidewall port device comprising a lattice inverted onto itself to form an inner tube disposed coaxially within an outer tube;
wherein the conduit comprises a flow frame locatable in the distal portion and configured to span at least a portion of the lumen cross-section of the first vessel to allow to allow downstream perfusion in addition to transmural flow; and
a compliant support locatable on the distal portion and configured to expand outwardly toward the inner walls of the second vessel when deployed.
17. The fistula device as set forth in claim 16 , wherein the first vessel is an artery and the second vessel is a vein.
18. The fistula device as set forth in claim 16 , wherein the compliant support is sufficiently flexible and generally compliant to minimize radial distension of the second vessel after deployment.
19. The fistula device as set forth in claim 16 , wherein the conduit is configured to bend and maintain an open lumen.
20. The fistula device as set forth in claim 19 , wherein the proximal portion of the conduit is configured to deploy within the first vessel and wherein conduit passes though an aperture within a sidewall of the first vessel.
21. The fistula device as set forth in claim 20 , wherein the conduit passes through an aperture within a sidewall of the second vessel and wherein the distal portion of the conduit is configured to deploy within the second vessel.
22. The fistula device as set forth in claim 16 , wherein the flow frame is formed from Nitinol.
23. The fistula device as set forth in claim 16 , wherein the flow frame comprises a whisk.
24. The fistula device as set forth in claim 23 , wherein the whisk comprises a cap configured to seal a puncture on a vessel wall.
25. The fistula device as set forth in claim 16 , wherein the flow frame comprises a bare stent.
26. The fistula device as set forth in claim 16 , wherein the compliant support in an uncompressed state has an outer diameter that is larger than that of the distal portion of the conduit.
27. The fistula device as set forth in claim 16 , wherein the compliant support comprises a wire frame made from Nitinol.
28. The fistula device as set forth in claim 16 , wherein the compliant support is fixedly secured to the conduit by an annular band.
29. The fistula device as set forth in claim 28 , wherein the annular band is formed from an ePTFE film.
30. The fistula device as set forth in claim 16 , wherein the compliant support is spaced apart from the conduit and coupled thereto solely by the annular band.
31. The fistula device as set forth in claim 16 further comprising a compressed configuration and an expanded configuration.
32. The fistula device as set forth in claim 16 is percutaneously deployable.