System and Method for Treating Pulmonary Edema

• US 20170197021A1
• Filed: 03/28/2017
• Published: 07/13/2017
• Est. Priority Date: 06/01/2014
• Status: Active Grant

• Current Assignee: White Swell Medical, Ltd. (WhiteSwell Ltd.)
• Original Assignee: White Swell Medical, Ltd. (WhiteSwell Ltd.)
• Inventors: Feld, Tanhum, Nitzan, Yaacov, Yacoby, Menashe
• Granted Patent: US 10,195,405 B2
• Time in Patent Office: Days
• CPC Class Codes: A61M 1/34 Filtering material out of the blood by passing it through a membrane, i.e. hemofiltration or diafiltration
• CPC Class Codes: A61M 1/3639 Blood pressure control, pressure transducers specially adapted therefor
• CPC Class Codes: A61M 1/3653 Interfaces between patient blood circulation and extra-corporal blood circuit
• CPC Class Codes: A61M 1/3655 Arterio-venous shunts or fistulae
• CPC Class Codes: A61M 1/3659 Cannulae pertaining to extracorporeal circulation
• CPC Class Codes: A61M 2025/0002 with a pressure sensor at the distal end
• CPC Class Codes: A61M 2025/1015 having two or more independently movable balloons where the distance between the balloons can be adjusted, e.g. two balloon catheters concentric to each other forming an adjustable multiple balloon catheter system
• CPC Class Codes: A61M 2025/1052 for temporarily occluding a vessel for isolating a sector
• CPC Class Codes: A61M 2202/0405 Lymph
• CPC Class Codes: A61M 2205/10 with powered movement mechanisms
• CPC Class Codes: A61M 2205/3331 Pressure; Flow
• CPC Class Codes: A61M 2205/3334 Measuring or controlling the flow rate
• CPC Class Codes: A61M 25/0026 Multi-lumen catheters with stationary elements catheter assemblies comprising a catheter in combination with a guide tube, sheath or sleeve A61M2025/0681; catheters comprising telescoping coaxial elements A61M2025/0175
• CPC Class Codes: A61M 25/1011 Multiple balloon catheters
• CPC Class Codes: A61M 27/002 Implant devices for drainage of body fluids from one part of the body to another intraocular A61F9/00781; middle ear A61F11/202

Abstract

Systems, methods, and devices are provided for the treatment of edema. In one aspect a method for implanting an indwelling catheter within a vein of a patient is provided. The catheter can extend from a position upstream of at least one outflow port of a duct of the lymph system to a terminal position downstream of the at least one outflow port. In use, a first restriction can be created within the vein proximal to a distal region of the catheter. The first restriction can define a localized low pressure zone distal of the restriction and within a portion of the vein housing the catheter. The low pressure zone can be adjacent to the at least one outflow port to enable fluid to pass from the at least one lymph duct outflow port into the vein.

Claims

1. A method of treating edema, comprising:

creating a restriction within a vein of a patient, the restriction being created at a single location upstream from an outflow port of a lymph duct and being effective to at least partially restrict blood flow within the vein past the restriction; and

forming a low pressure zone within the vein at a position downstream of the location of the restriction as a result of creating the restriction, the low pressure zone being effective to enhance clearance of lymphatic fluid from the lymph duct.

2. The method of claim 1, wherein the low pressure zone is adjacent to the outflow port to enable fluid to pass from the outflow port into the vein.

3. The method of claim 1, wherein the lymph duct is at least one of the thoracic duct and the lymphatic duct.

4. The method of claim 1, wherein the restriction comprises a selectively expandable balloon formed on an outer wall of a catheter.

5. The method of claim 4, wherein creating the restriction comprises activating the balloon to move it into an expanded configuration.

6. The method of claim 5, further comprising monitoring pressure in locations in the patient upstream and downstream of the restriction, and adjusting a degree of expansion of the balloon based on the monitoring of the pressure.

7. The method of claim 1, further comprising monitoring pressure in at least one location in the patient upstream and/or downstream of the restriction.

8. The method of claim 7, further comprising adjusting an extent of the restriction based on the monitoring of the pressure.

9. The method of claim 1, wherein the restriction is created in one of the right and left internal jugular veins.

10. An indwelling catheter system configured to be implantable within a vein of a patient, comprising:

a catheter having a lumen configured to accommodate passage of fluid therethrough;

an inflow port formed in a wall of the catheter;

a single selectively deployable restrictor for creating a restriction in the vein, the single restrictor coupled to the catheter at a location proximal to the inflow port, the restriction being effective to occlude the vein and to at least partially restrict blood flow within the vein so as to create a low pressure zone downstream of the restriction; and

an activation lumen associated with the catheter and configured to enable selective activation of the single restrictor.

11. The system of claim 10, wherein the single restrictor comprises a selectively inflatable balloon.

12. The system of claim 10, wherein the single restrictor comprises a selectively deployable adjustable restrictor.

13. The system of claim 12, wherein the selectively deployable adjustable restrictor comprises a balloon.

14. The system of claim 10, wherein the activation lumen comprises an inflation lumen.

15. The system of claim 10, wherein the lumen of the catheter has a diameter in the range of about 1 to 4 mm.

16. The system of claim 10, further comprising at least one pressure sensor.

17. The system of claim 16, further comprising a mechanism configured to adjust a degree of restriction created by the single restrictor, based on information acquired by the at least one pressure sensor.

18. The system of claim 16, wherein the pressure sensor comprises a first pressure sensor located proximal to the restriction and a second pressure sensor located distal to the restriction.