IP Library Granted Patent US 10,960,189
Granted Patent B2
US 10,960,189 · App. 15/799,562 · Granted Mar 30, 2021

Systems and methods for treatment of fluid overload

Inventors: Yaacov Nitzan (Hertzeliya, IL); Sagi Raz (Tel-Aviv, IL); Shani Chen (Givatayim, IL); Or Inbar (Tel-Aviv, IL)
Assignee: White Swell Medical Ltd
A61M27/002A61B17/12045A61B17/12136A61F2/00A61F2/06A61M1/00A61M25/10184A61F2002/068A61M2025/1015A61M2025/1022A61M2025/1052A61M2025/1097A61M2202/0405A61M2205/3317A61M2205/3344A61M2205/8206A61M2210/12A61M2230/30
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Quick Facts
Patent No.
US 10,960,189
App. No.
15/799,562
Granted
Mar 30, 2021
Kind
B2
Abstract

Various systems and methods are provided for reducing pressure at an outflow of a duct, such as the thoracic duct or the lymphatic duct, for example, the right lymphatic duct. A catheter system can be configured to be at least partially implanted within a vein of a patient in the vicinity of an outflow port of a duct of the lymphatic system. The catheter system includes first and second selectively deployable restriction members each configured to be activated to at least partially occlude the vein within which the catheter is implanted and to thus restrict fluid within a portion of the vein. The catheter system includes an impeller configured to be driven by a motor to induce a low pressure zone between the restriction members by causing blood to be pumped through the catheter when the restriction members occlude the vein.

Claims (29)

1. A medical system for treating fluid overload, comprising:

a catheter configured for at least partial placement within a vein of a patient, the catheter including

an indwelling catheter tube having a lumen extending therethrough, the lumen configured to receive a drive shaft having a distal end thereof operatively coupled to an impeller,

a first selectively deployable restriction member adjacent to the impeller, the impeller disposed at least partially distal to the first selectively deployable restriction member, the first selectively deployable restriction member disposed around a first portion of the catheter shaft;

a second selectively deployable restriction member proximal to the first restriction member when the catheter is inside the vein; and

a motor configured to rotate the drive shaft and thereby rotate the impeller coupled to the drive shaft.

2. The system of claim 1 , further comprising a flow regulation component configured to direct a controlled volume of fluid from an upstream side of the second restriction member to a downstream side of the second restriction member, the flow regulation component having at least one opening configured to allow fluid flow therethrough.

3. The system of claim 2 , wherein the flow regulation component is operatively coupled to the second restriction member.

4. The system of claim 2 , wherein the flow regulation component is configured to direct fluid through a lumen defined by second restriction member.

5. The system of claim 1 , further comprising a controller configured to control operation of the motor based on measurements of fluid pressure acquired by at least one pressure sensor located between the first and second restrictors.

6. The system of claim 1 , wherein the first and second restriction members each include a selectively expandable element configured to be expanded radially.

7. The system of claim 1 , wherein the catheter tube has at least one inflation lumen configured to deliver a fluid or gas to activate the first and second restriction members.

8. The system of claim 1 , wherein the first restriction member has a first inner lumen that allows fluid to pass therethrough.

9. The system of claim 8 , further comprising an impeller housing configured to encompass the impeller.

10. The system of claim 9 , wherein the impeller housing comprises at least one opening at a distal end thereof such that fluid passing through the impeller housing from a proximal end thereof towards the distal end thereof can exit the impeller housing through the opening.

11. A medical system for treating fluid overload, comprising:

a catheter configured for at least partial placement within a vein of a patient, the catheter including

an indwelling catheter tube having a lumen extending therethrough, the lumen configured to receive a drive shaft having a distal end thereof operatively coupled to an impeller,

a first selectively deployable restriction member adjacent to the impeller the first selectively deployable restriction member disposed around a first portion of the catheter shaft;

a second selectively deployable restriction member proximal to the first restriction member when the catheter is inside the vein wherein the first restriction member has a first inner lumen comprising a shaft holder, the shaft holder being configured to receive the catheter tube thereto so as to maintain a position of the catheter tube; and

a motor configured to rotate the drive shaft and thereby rotate the impeller coupled to the drive shaft.

12. A method of treating fluid overload, comprising:

implanting a catheter within a vein of a patient, the catheter extending from a first position at one side of an outflow port of a duct to a second position at another side of the outflow port;

creating a first restriction within the vein proximal to a distal region of the catheter;

creating a second restriction within the vein proximal to a first restriction; and

activating an impeller of the catheter so as to define a localized low pressure zone between the second and first restrictions and adjacent to the outflow port of the duct, at least a portion of the impeller located distal to the first restriction, the low pressure zone being created by causing fluid to pass from a proximal side of the second restriction to a distal side of the second restriction and from a proximal side of the first restriction to a distal side of the first restriction.

13. The method of claim 12 , wherein creating the first restriction comprises deploying a first selectively expandable restrictor and creating the second restriction comprises deploying a second selectively expandable restrictor such that the fluid passes from the proximal side of the second restriction to the distal side of the first restriction by passing through an inner lumens of the first restrictor and towards the impeller.

14. The method of claim 12 , wherein the vein includes at least one of an internal jugular vein and a subclavian vein.

15. The method of claim 12 , wherein the duct includes one of a thoracic or a right lymphatic duct.

Assignments (1)
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded May 23, 2018
From: NITZAN, YAACOV; RAZ, SAGI; CHEN, SHANI; INBAR, OR
To: WHITE SWELL MEDICAL LTD
Reel/Frame 045879/0057 →
Continuity (4)
Provisional Application 62415684 · Nov 1, 2016
Provisional Application 62415964 · Nov 1, 2016
Provisional Application 62445231 · Jan 11, 2017
Related Publication 20180126130A1 · May 10, 2018
Cited By (10)
US 12,257,425 US 12,318,561 US 12,458,359 US 12,472,334 US 12,502,474 US 12,544,075 US 12,569,654 US 12,605,494 US 12,667,704 US 12,673,180