Devices and methods for treating edema

Patent metadata

Field	Value
Publication number	US-11660426-B2
Application number	US-202016801994-A
Country	US
Kind code	B2
Filing date	Feb 26, 2020
Priority date	Feb 26, 2019
Publication date	May 30, 2023
Grant date	May 30, 2023

Abstract

The disclosure relates to devices and methods for the treatment of edema that uses an impeller with a balloon that may be mounted on the impeller housing. The invention provides devices and methods for treatment of edema that use an indwelling catheter with an impeller to lower pressure at an outlet of a lymphatic duct and a balloon on the impeller to guide and to restrict blood flow. The balloon restricts return flow from the jugular and guides that flow into the impeller cage. By funneling the flow into the impeller cage, a rate of flow down the vessel may be increased, resulting in a lateral pressure decrease effecting the lymphatic outlet. Because the lymphatic outlet is subject to a pressure decrease, fluids in the lymphatic system drain to the outlet and into the circulatory system.

First claim

What is claimed is:

1. A device comprising:
a catheter comprising a proximal portion and a distal portion;
an impeller housing attached to the distal portion of the catheter with an impeller disposed therein; and
an expandable member aligned over an outside of the impeller housing, wherein an exterior surface of the expandable member is physically coupled directly to the exterior surface of the impeller housing without any membrane, sheath, or device between the exterior surface of the expandable member and the exterior surface of the impeller housing, and wherein, when the expandable member is expanded, the expandable member directs fluid flow to an inlet of the impeller housing.

2. The device of claim 1 , wherein the expandable member is physically coupled to an exterior surface of the impeller housing.

3. The device of claim 2 , wherein the exterior surface of the expandable member is physically coupled directly to the exterior surface of the impeller housing without any membrane, sheath, or device between the exterior surface of the expandable member and the exterior surface of the impeller housing.

4. The device of claim 1 , wherein the expandable member surrounds, and is attached to, a proximal end of the impeller housing.

5. The device of claim 1 , wherein the expandable member is a balloon that, when expanded, defines a toroidal shape and wherein a proximal surface of the toroidal shape directs fluid into the impeller housing.

6. The device of claim 5 , wherein the balloon is inflatable and further wherein the balloon surrounds, and is attached to, a proximal end of the impeller housing, and further wherein the toroidal shape funnels fluid into an inlet of the impeller housing.

7. The device of claim 1 , wherein the impeller housing comprises a metal and a portion of the expandable member is fixed to a surface of the metal by an adhesive.

8. The device of claim 7 , wherein at least a portion of the surface of the metal is impregnated with a polymer to promote bonding to the adhesive.

9. The device of claim 1 , further comprising:
a motor housing connected to the proximal portion of the catheter;
a motor disposed within the motor housing;
a drive cable extending through the catheter from the motor to the impeller; and
an inflation lumen extending along the catheter to the expandable member.

10. A method of using the device of claim 1 for treating edema, the method comprising inserting the distal portion of the catheter into an innominate vein of a patient, operating the impeller, and expanding the expandable member to thereby decrease pressure at a lymphatic duct.

11. A device comprising:
a catheter with a proximal portion and a distal portion, the distal portion dimensioned for insertion into a lumen of a patient and comprising a housing having a pump disposed within the housing; and
an expandable member connected to the pump, wherein when expanded, the expandable member comprises a toroidal shape, wherein a proximal surface of the toroidal shape and an inner surface of the housing form a smooth continuous surface that funnels fluid, under power of pump, through the housing.

12. The device of claim 11 , wherein the housing comprises a metal and a portion of the expandable member is fixed to a surface of the metal by an adhesive, wherein at least a portion of the surface of the metal is impregnated with a polymer to promote bonding to the adhesive.

13. The device of claim 11 , wherein the expandable member comprises an inflatable balloon mounted on a proximal end of the housing of the pump.

14. The device of claim 13 , wherein the pump comprises an impeller disposed within the housing, with the balloon mounted around the proximal end of the housing.

15. The device of claim 14 , wherein the housing comprises a distal portion and a proximal portion, wherein an external diameter of proximal portion is smaller than an external diameter of the distal portion, wherein the expandable member, when not expanded, is disposed around the proximal portion of the housing.

16. The device of claim 15 , wherein the impeller comprises one or more blades on a shaft, wherein a radial measurement taken from an axis of the impeller to an outer edge of the blades decreases from a distal to a proximal portion of the impeller.

17. The device of claim 16 , wherein the outer edge of each blade includes a dogleg defining a step-down in radius located adjacent a transition between the distal portion and the proximal portion of the impeller housing.

18. The device of claim 15 , wherein the distal portion of the impeller housing comprises one or more outlets and, wherein the impeller shaft flares outwards near a distal end of the impeller such that when the impeller is rotated, the impeller pumps blood through the impeller housing and out of the one or more outlets.

19. The device of claim 11 , wherein the pump comprises an impeller disposed within the housing and the expandable member comprises an inflatable balloon connected to an exterior surface at a proximal end of the impeller housing.

20. The device of claim 19 , wherein when the balloon is inflated, it defines a torus.

Assignees

• White Swell Medical Ltd

Inventors

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

Classifications

• A61M60/833 Primary

  Occluders for preventing backflow · CPC title

• A61M2205/3341

  stabilising pressure or flow to avoid excessive variation · CPC title

• A61M2025/1022

  driven by a rotary motor-activated pump · CPC title

• A61M25/1018 Primary

  Balloon inflating or inflation-control devices · CPC title

• A61M2205/3334

  Measuring or controlling the flow rate · CPC title