System and Method for Treatment of Pulmonary Edema

• US 20150343136A1
• Filed: 02/19/2015
• Published: 12/03/2015
• 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: Nitzan, Yaacov, Yacoby, Menashe, Feld, Tanhum
• Granted Patent: US 9,901,722 B2
• Time in Patent Office: Days
• US Class Current: 1/1
• 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:

implanting an indwelling catheter within a vein of a patient, the catheter extending 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; and

creating a first restriction within the vein proximal to a distal region of the catheter, the first restriction defining a localized low pressure zone distal of the restriction and within a portion of the vein housing the catheter, the low pressure zone being 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.

2. The method of claim 1, further comprising creating a second restriction within the vein that is distal to the first restriction and adjacent to a proximal region of the catheter, the localized low pressure zone extending between the first and second restrictions.

3. The method of claim 2, wherein the catheter is a multilumen catheter including a suction lumen and a discharge lumen, the suction lumen being in communication with a suction port formed in the catheter to withdraw fluid from the vein through the action of an external pump, and the discharge lumen being in communication with a discharge line of the pump to return fluid to venous circulation through a discharge port in the catheter.

4. The method of claim 3, wherein the suction port is disposed between the first and second restrictions and the discharge port is disposed distal of the second restriction.

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

6. The method of claim 2, wherein the second restriction is a selectively expandable balloon formed on an outer wall of the catheter.

7. The method of claim 3, wherein the catheter includes a plurality of control lumens, each configured to receive a pressure sensor.

8. The method of claim 7, further comprising monitoring the pressure in at least one of a position within the vein upstream of the first restriction, between the first and second restrictions, and downstream of the second restriction.

9. The method of claim 1, wherein the catheter is a first catheter and further comprising a second catheter implanted within a second vein, the second catheter being in communication with an external pump and wherein fluid is withdrawn from the second vein through the action of the pump and returned to the first catheter through a discharge line of the pump.

10. The method of claim 9, wherein the fluid is discharged into the vein through a discharge port in the first catheter at a position downstream of the second restriction.

11. The method of claim 3, further comprising a hemofilter in communication with the discharge line of the pump, the hemofilter having a discharge line in communication with the discharge line of the pump downstream of the hemofilter.

12. The method of claim 11, further comprising a diverter upstream of the hemofilter.

13. The method of claim 3, wherein the catheter is implanted in one of the right and left internal jugular vein and advanced to a position such that the discharge port is distal to the junction of the subclavian vein and the internal jugular vein, the first restriction being within the internal jugular vein, the second restriction being within the innominate vein, and the suction port being adjacent the subclavian vein.

14. A system for treating edema, comprising:

a catheter system configured for placement within a vein of a patient, the catheter system having selectively deployable proximal and distal restrictions disposed within an indwelling portion of the catheter system, a blood inflow suction port disposed between the proximal and distal restrictions and in fluid communication with a suction lumen of the catheter system that is effective to remove fluid from venous circulation, a discharge port disposed distally of the distal restrictor and in fluid communication with a discharge lumen of the catheter and configured to return fluid to venous circulation;

a pump configured to create a pressure differential to withdraw fluid from the suction port and through the suction lumen to withdraw a fluid within a vein from venous circulation and to return the fluid to venous circulation through the discharge lumen and the discharge port;

a plurality of pressure sensors disposed within the catheter system, the pressure sensors being configured to determine venous pressure upstream of the proximal restriction, between the proximal and distal restriction, and downstream of the distal restriction; and

a control module configured to control operation of the system.

15. The system of claim 14, wherein the pump is configured to be positioned external to the patient.

16. The system of claim 14, wherein the pump a peristaltic flow pump.

17. The system of claim 14, wherein the sensor is a blood pressure sensor.

18. An indwelling catheter configured to be implantable within a vein of a patient, comprising;

a catheter body having a plurality of lumens, including

an inflow lumen configured to be in communication with a suction port of a pump,

an outflow lumen configured to be in communication with a discharge line of the pump, and

a plurality of sensor lumens, each configured to receive a pressure sensor;

a selectively deployable proximal restriction disposed within a proximal region of the catheter body;

a selectively deployable distal restriction disposed on at least a portion of an outer wall of the catheter body;

a blood inflow suction port formed in a wall of the catheter and in fluid communication with the inflow lumen; and

a discharge port disposed distally of the second restriction,

the catheter further including an inflation lumen for each of the first restriction and the second restriction.

19. The indwelling catheter of claim 18, wherein the distal restriction is a selectively inflatable balloon.

20. The indwelling catheter of claim 19, wherein the proximal restriction is a selectively inflatable balloon.

21. The indwelling catheter of claim 19, wherein the indwelling catheter has a diameter in the range of about 5 to 20 mm.

22. The indwelling catheter of claim 19, wherein each of the inflow lumen and the outflow lumen have a diameter in the range of about 1 to 4 mm.

23. The indwelling catheter of claim 19, wherein the suction port is disposed substantially midway between the proximal and distal restrictions.

24. The indwelling catheter of claim 19, wherein the distance between the proximal and distal restrictions is about 1 to 15 cm.

25. The indwelling catheter of claim 19, further comprising a sensor port in communication with each of the sensor lumens.

26. The indwelling catheter of claim 25, wherein a first sensor port is disposed proximally of the proximal restriction, a second sensor port is disposed between the proximal and distal restrictions, and a third sensor port is disposed distally of the distal restriction.

27. A method of positioning an indwelling catheter for treating pulmonary edema, comprising;

inserting the indwelling catheter into a jugular vein of a patient;

advancing the indwelling catheter until a distal restriction, a proximal sensor and a distal sensor positioned on the indwelling catheter are disposed within the jugular vein of the patient;

activating the distal restriction until an initial pressure gradient is present between the proximal sensor and the distal sensor, which is disposed distally of the distal restriction;

maintaining the distal restrictor activation level at the activation level at which the pressure gradient is detected;

advancing the indwelling catheter until the pressure gradient deviates from the initial pressure gradient between the proximal sensor and the distal sensor, thereby indicating a distal end of the indwelling catheter is positioned within a subclavian vein ostium of the patient;

observing a percutaneous insertion length of the indwelling catheter; and

advancing the indwelling catheter a pre-determined distance until the distal restrictor is within an innominate vein of the patient.

28. A system for treating edema, comprising:

a stent configured for placement within a vein of a patient, the stent having opposed ends of an expanded diameter configured to engage walls of a vein and a central portion having a reduced diameter, the stent having a fluid conduit extending therethrough from a first end to a second end and a suction conduit extending from a suction port formed in a central portion of the stent;

a pump configured to create a pressure differential to withdraw fluid from the suction port and through the suction conduit to withdraw a fluid adjacent to the suction port and the discharge port; and

a control module configured to control operation of the system.