Devices and methods for treating edema

Patent metadata

Field	Value
Publication number	US-11717652-B2
Application number	US-202016802029-A
Country	US
Kind code	B2
Filing date	Feb 26, 2020
Priority date	Feb 26, 2019
Publication date	Aug 8, 2023
Grant date	Aug 8, 2023

Abstract

The disclosure relates to devices and methods for the treatment of edema, which devices use a restrictor for flow compensation. Devices and methods of the invention further use a flow-restrictor in the circulatory system, upstream of an intravascular pump, to balance pressure changes induced by the pump and to compensate for downstream flow. The device may be provided as an indwelling, intravascular catheter with a mechanical pump such as an impeller and a selectively deployable restrictor such as an inflatable balloon. Congestive heart failure or edema is treated by \ operating the pump in an innominate vein and using the restrictor for flow compensation, to restrict the upstream flow and thus amplify or maintain pressure reduction at the lymphatic outlet.

First claim

What is claimed is:

1. A device comprising:
a catheter with a proximal portion and a distal portion;
a cap over a distal end of the catheter, wherein the cap comprises a guide surface;
a plurality of struts extending distally from the cap; and
an impeller assembly connected to the distal portion, the impeller assembly comprising an impeller housing attached to distal ends of the struts and an impeller operably disposed within the assembly wherein the cap extends into a proximal base of the impeller assembly such that a distal end of the cap is adjacent to a proximal end of the impeller, wherein the housing, the cap, and the struts define inlets with rounded corners along an outer surface of the impeller housing and into the impeller assembly, and wherein the guide surface is configured to smoothly change a cross-sectional area at the inlets, such that flow into the inlets and into the impeller assembly is achieved without recirculation.

2. The device of claim 1 , wherein when the impeller operates within a blood vessel, blood flows through a housing of the impeller assembly without recirculation.

3. The device of claim 1 , wherein the strut comprises an inflation lumen extending therethrough for inflating a balloon mounted on the impeller assembly.

4. The device of claim 1 , wherein the strut is substantially parallel to an axis of the impeller and wherein the device further comprises an expandable member attached to the outer surface of the impeller housing distal to the inlets.

5. The device of claim 1 , wherein the strut defines a vane within the impeller assembly that channels fluid flow when the impeller operates to thereby prevent the recirculation or vortices.

6. The device of claim 5 , wherein the strut comprises a fluidic lumen extending therethrough, wherein the fluidic lumen is non-concentric with at least a portion of the body of the strut due to material of the strut forming the vane within the impeller assembly.

7. The device of claim 1 , comprising three of the struts, wherein each of the three struts defines a vane within the impeller assembly that channels fluid flow when the impeller operates to thereby prevent the recirculation or vortices.

8. The device of claim 2 , further comprising a medicament lumen extending through the catheter and terminating substantially within a proximal portion of the impeller assembly such that a medicament released from the medicament lumen flows through the inlet and impeller assembly.

9. The device of claim 2 , wherein the catheter comprises a tube with a drive cable extending there through with the cap connected around a terminal portion of the tube.

10. The device of claim 1 , wherein the impeller housing includes one or more outlets around a distal portion of the impeller, wherein operation of the impeller within a blood vessel drives blood into the impeller assembly via the inlets and out of the impeller assembly via the outlets such that the blood exhibits laminar flow without the recirculation or vortices.

11. A method of treating edema, the method comprising:
inserting into an innominate vein of a patient a distal portion of a catheter, the catheter comprising an impeller assembly on the distal portion; and
driving an impeller disposed within the impeller assembly to thereby decrease pressure at a lymphatic duct, wherein a proximal portion of the impeller assembly is configured to facilitate flow into inlets into an outer surface of a housing of the impeller assembly without recirculation, wherein the catheter comprises a cap secured over a distal end of a tube, the cap comprising a guide surface, at least one strut extending distally from the cap and parallel to an axis of the impeller, and the housing connected to distal ends of the struts, wherein the cap extends into a proximal base of the impeller assembly such that a distal end of the cap is adjacent to a proximal end of the impeller, wherein the housing, the cap, and the at least one strut define the inlets and define rounded corners of the inlets, and wherein the guide surface is configured to smoothly change a cross-sectional area at the inlets, such that smooth contact surfaces are provided to achieve blood flow through the impeller housing without recirculation.

12. The method of claim 11 , wherein the catheter comprises a plurality of struts and said struts define vanes within the impeller assembly that channel fluid flow when the impeller operates to thereby prevent the recirculation or vortices.

13. The method of claim 12 , wherein at least one strut comprises a fluidic lumen extending therethrough, wherein the fluidic lumen is non-concentric with at least a portion of the body of the strut due to material of the strut forming the vane within the impeller assembly.

14. The method of claim 11 , further comprising inflating an inflatable flow restrictor mounted on the outer surface of the housing of the impeller assembly by delivering an inflation fluid to the restrictor via an inflation lumen extending through the catheter.

15. The method of claim 11 , wherein the impeller housing includes one or more outlets around a distal portion of the impeller, wherein operation of the impeller within a blood vessel drives blood into the impeller assembly via the inlets and out of the impeller assembly via the outlets such that the blood exhibits smooth laminar flow without the recirculation or vortices.

Assignees

• White Swell Medical Ltd

Inventors

• Nitzan Yaacov
• Keating Ronan
• Marmur Shahaf
• Inbar Or
• Brady Eamon
• Mccaffrey Gerry
• Williston Reed
• Raz Sagi

Classifications

• A61M25/10184 Primary

  Means for controlling or monitoring inflation or deflation · CPC title

• A61M2205/3337

  Controlling, regulating pressure or flow by means of a valve by-passing a pump · CPC title

• A61M60/205 Primary

  Non-positive displacement blood pumps · CPC title