Devices and methods for treating edema
The disclosure relates to devices and methods for the treatment of edema using a purge-free system. The invention provides devices and methods useful for treating edema by means of an indwelling catheter that is placed in a blood vessel of a patient and used to pump blood to cause a decrease in pressure at an outlet of a lymphatic duct. The catheter pumps blood by means of an impeller but is purge-free in that the catheter does not include a system for purging or flushing catheter components with a purge fluid. The purge-free catheter avoids blood-related mechanical complications such as clotting or thrombosis by means of an impermeable sleeve or shroud that protects moving parts of the impeller drive system.
1. A device comprising:
an indwelling catheter comprising a proximal portion and a distal portion;
an impeller assembly mounted at the distal portion of the catheter, the impeller assembly comprising an impeller housing with an impeller disposed therein, wherein the catheter distal portion and the impeller assembly are dimensioned to be navigated through a blood vessel of a patient, and a cuff comprising a distal surface wherein a proximal end of a core diameter of the impeller rotates in clearance of the distal surface of the cuff;
a motor connected to the proximal portion of the catheter;
a drive cable extending through the catheter from the motor to the impeller; and
an impermeable sleeve extending through the catheter over the drive cable, the sleeve comprising a distal seal adjacent the impeller and/or a proximal seal adjacent the motor such that a body fluid external to the impermeable sleeve is prevented from entering the impermeable sleeve and contacting the drive cable.
2. The device of claim 1 , wherein a clearance between the cuff distal surface and the impeller defines a proximal gap.
3. The device of claim 2 , wherein the proximal gap is configured to define a transition between a static core of the impeller assembly to a rotating core of the impeller.
4. The device of claim 2 , wherein the proximal gap is configured to remain fixed during operation of the device.
5. The device of claim 2 , wherein the proximal gap is configured to allow blood to flow across the proximal gap without flow disturbance, flow recirculation, or vortices.
6. The device of claim 2 , wherein the proximal gap is in fluid communication with a catheter lumen.
7. The device of claim 6 , wherein the fluid lumen is in fluid communication with a fluid reservoir exterior of a patient.
8. The device of claim 7 , wherein the proximal gap is configured to provide resistive fluid pressure to prevent blood from entering the proximal gap.
9. The device of claim 7 , wherein the fluid is a purge fluid to flush blood from the proximal gap.
10. The device of claim 1 , wherein the cuff further comprises a proximal surface, wherein the proximal surface of the cuff comprises a guide surface, and one or more struts extending from the proximal surface of the cuff to the impeller housing.
11. The device of claim 10 , wherein the impeller assembly further comprises a proximal inlet region and a distal outlet region, wherein the guide surface tapers toward the impeller to change a cross sectional area along a length at the inlet region.
12. The device of claim 11 , wherein the guide surface, the struts, and the impeller housing define the inlet region such that fluid divergence in the inlet region is minimized.
13. The device of claim 11 , wherein the guide surface comprises one or more of a curved tapered section, a cylindrical region, and a substantially conical region.
14. The device of claim 12 , wherein operation of the impeller within a blood vessel drives blood into the impeller assembly via the inlet region and out of the impeller assembly via the outlet region such that flow into the inlet region and into the impeller assembly is achieved without recirculation or vortices.
15. The device of claim 11 , further comprising an expandable member connected directly to an outer surface of the impeller housing, wherein the expandable member comprises a collapsed configuration and an expanded configuration.
16. The device of claim 15 , wherein the expandable member is positioned between the proximal inlet region and the distal outlet region.
17. The device of claim 16 , wherein, when in an expanded configuration, an axial length of the expandable member extends beyond the impeller housing.
18. The device of claim 15 , wherein the expandable member comprises a toroidal balloon, wherein, when in an expanded configuration, the toroidal balloon surrounds the impeller housing.
19. The device of claim 1 , wherein the proximal seal comprises a fitting between the impermeable sleeve and a portion of the impeller, wherein the fitting excludes fluids and allows the impeller and drive cable to rotate within the device.
20. The device of claim 1 , wherein the distal portion of the catheter is configured for insertion into a vessel of a patient and the proximal portion of the catheter is configured to extend exterior of the patient.
21. The device of claim 1 , wherein the distal seal is configured to prevent bodily fluid entering the impermeable sleeve.
22. The device of claim 1 , wherein the distal seal is configured to prevent body fluids from contacting the drive cable.
23. The device of claim 1 , wherein the distal seal and the impermeable sleeve are together configured to exclude body fluids and allow the impeller and drive cable to rotate within the device.
24. The device of claim 1 , wherein the impermeable sleeve extending over the drive cable comprises a clearance between the drive shaft and the impermeable sleeve.
25. The device of claim 24 , wherein the clearance between the drive shaft and the impermeable sleeve is less than 0.1 microns.
26. The device of claim 1 , wherein the impermeable sleeve comprises a closed distal end near the impeller configured to protect the drive cable and to exclude blood or bodily fluids.
27. The device of claim 26 , wherein the impermeable sleeve with the closed distal end comprises a sealed sleeve to prevent clotting or hemolysis.
28. The device of claim 26 , wherein the impermeable sleeve with the closed distal end excludes blood from at least some of the catheter moving parts.
29. The device of claim 1 , wherein the impermeable sleeve comprises a hydrophobic polymer material.