Devices and methods for treating edema

Patent metadata

Field	Value
Publication number	US-11724095-B2
Application number	US-202016801952-A
Country	US
Kind code	B2
Filing date	Feb 26, 2020
Priority date	Feb 26, 2019
Publication date	Aug 15, 2023
Grant date	Aug 15, 2023

Abstract

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.

First claim

What is claimed is:

1. A device comprising:
an indwelling catheter comprising a proximal portion and a distal portion;
an impeller connected to the distal portion of the catheter, wherein the distal portion and the impeller are dimensioned to be navigated through a jugular vein of a patient to place the impeller in the jugular vein or at least partially within an innominate vein near an outlet of a lymphatic duct;
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 at the impeller and a proximal seal at 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 the sleeve and at least the distal seal exclude fluid from the drive cable.

3. The device of claim 2 , wherein the proximal seal includes an O-ring.

4. The device of claim 1 , further comprising a first lumen and a second lumen, both extending through the catheter, wherein the first lumen and the second lumen have respective first and second proximal ends accessible outside of the motor housing.

5. The device of claim 4 , wherein the first lumen and the second lumen are symmetrically disposed about the drive cable to impart balance to the device.

6. The device of claim 1 , wherein when the catheter does not include a purge system or a purge fluid.

7. The device of claim 1 , wherein the impeller sits in an impeller housing, the device further comprising at least a first expandable member connected to the distal portion of the catheter.

8. The device of claim 7 , wherein the first expandable member is connected to the impeller housing, wherein the device further comprises a second expandable member disposed along the catheter.

9. The device of claim 8 , wherein the first expandable member comprises a toroidal balloon connected directly to a surface of the impeller housing.

10. The device of claim 1 , further comprising at least one pressure sensor disposed along the catheter proximal to the impeller.

11. 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.

12. 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.

13. The device of claim 1 wherein the motor is configured to rotate at high speed and the catheter is configured to transmit said rotational speed through the catheter to the impeller.

14. The device of claim 13 wherein the catheter is configured to transmit a rotational speed of greater than 5,000 rpms to the impeller.

15. The device of claim 14 , wherein the catheter is configured for heatless operation while transmitting high rotational speeds to the impeller.

16. The device of claim 15 wherein the impermeable sleeve comprises a thick walled PTFE tubing.

17. The device of claim 16 wherein the thick walled PTFE tubing comprises a wall thickness of greater than 75 micrometers.

18. The device of claim 1 wherein the drive cable comprises a cylindrical superelastic member over at least a portion of the length of a drive shaft comprising the drive cable.

19. The device of claim 1 wherein the impermeable sleeve comprises hydrophobic material.

20. The device of claim 1 wherein the impermeable sleeve comprises a material with a Hildebrand solubility parameter of less than 16 MPa{circumflex over ( )}(0.5).

Assignees

• White Swell Medical Ltd

Inventors

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

Classifications

• A61M60/414 Primary

  transmitted by a rotating cable, e.g. for blood pumps mounted on a catheter · CPC title

• A61M25/10

  Balloon catheters ({A61M25/0125 takes precedence; embolectomy A61B17/22032; retractors A61B17/02;} inflatable balloons for placing stents or stent-grafts A61F2/958 {; stomach balloons for treatment of obesity A61F5/0003; oesophagal tubes A61J15/00}) · CPC title

• A61M25/1002

  characterised by balloon shape (A61M25/1006, A61M25/1009 take precedence) · CPC title

• A61M1/85

  with gas or fluid supply means, e.g. for supplying rinsing fluids or anticoagulants (for negative pressure wound therapy A61M1/92, A61M1/94; combined with tracheal tubes A61M16/0463; dental instruments with combined rinsing and aspirating A61C17/0208) · CPC title

• A61M60/126

  implantable via, into, inside, in line, branching on, or around a blood vessel · CPC title