Flow modification in body lumens
The devices and methods described herein include an implantable body lumen fluid flow modulator including an upstream flow accelerator separated by a gap from a downstream flow decelerator. The gap is a pathway to entrain additional fluid from a branch lumen(s) into the fluid stream flowing from the upstream flow accelerator to the downstream flow decelerator.
1. A method for modifying blood flow to treat heart failure, the method comprising:
percutaneously delivering a flow modulator compressed in a delivery sheath into an inferior vena cava, the flow modulator comprising a frame having a coating;
deploying a downstream diffuser of the flow modulator from the delivery sheath within the inferior vena cava downstream from a branch off to a renal vein, wherein the downstream diffuser comprises a cross-sectional flow area that diverges from an entry of the downstream diffuser in a downstream direction towards an exit of the downstream diffuser; and
deploying an upstream nozzle of the flow modulator from the delivery sheath within the inferior vena cava upstream from the branch off to the renal vein such that uncoated portions of the frame, which are located around a circumference of the downstream diffuser where the downstream diffuser is diverging, define a gap positioned where the branch off to the renal vein intersects with the inferior vena cava,
wherein blood flow passing through the upstream nozzle is accelerated towards the downstream diffuser to generate a low pressure region in a vicinity of the gap to draw and entrain additional blood into the flow modulator via the gap from the renal vein, thereby treating heart failure.
2. The method of claim 1 , wherein the coating comprises polyurethane.
3. The method of claim 1 , wherein the frame comprises nitinol.
4. The method of claim 1 , wherein the upstream nozzle and the downstream diffuser are formed from the frame having the coating.
5. The method of claim 1 , wherein the upstream nozzle and the downstream diffuser are formed from the frame which is a single frame.
6. The method of claim 1 , wherein the upstream nozzle comprises a cross-sectional flow area that converges from an inlet of the upstream nozzle in a downstream direction towards an outlet of the upstream nozzle.
7. The method of claim 1 , wherein deploying the downstream diffuser and the upstream nozzle comprises expanding the downstream diffuser and the upstream nozzle within the inferior vena cava.
8. The method of claim 1 , wherein the flow modulator is configured for an acute treatment, the method further comprising: after the acute treatment, removing the flow modulator from the inferior vena cava.
9. The method of claim 1 , wherein a cross-sectional flow area at an outlet of the upstream nozzle is less than a cross-sectional flow area at an entry of the downstream diffuser.
10. The method of claim 1 , wherein the upstream nozzle and the downstream diffuser are configured to share a common, collinear flow axis with the inferior vena cava's flow axis.
11. The method of claim 1 , wherein the upstream nozzle's average angle of convergence is greater than the downstream diffuser's average angle of divergence.
12. The method of claim 1 , wherein the downstream diffuser's length is greater than the upstream nozzle's length.
13. The method of claim 1 , wherein the gap's length is equal to a distance between an outlet of the upstream nozzle and an entry of the downstream diffuser.
14. The method of claim 13 , wherein the distance between the outlet of the upstream nozzle and the entry of the downstream diffuser is less than 15 mm.
15. The method of claim 1 , wherein drawing blood from the renal vein improves kidney functionality.
16. The method of claim 1 , wherein the flow modulator modulates blood flow without any input from an external energy source.
17. The method of claim 1 , wherein the flow modulator further comprises a retrieval portion extending in an upstream direction from an inlet of the upstream nozzle, the method further comprising:
coupling a retrieval device to the retrieval portion; and
pulling the retrieval portion via the retrieval device to compress the flow modulator into a collapsed delivery state.
18. The method of claim 17 , wherein the retrieval portion comprises a cross-sectional area that converges from the inlet towards an upstream end of the retrieval portion.
19. The method of claim 18 , wherein the upstream end of the retrieval portion comprises a hook.