Implantable fluid management system for the removal of excess fluid

• US 8,882,699 B2
• Filed: 08/22/2013
• Issued: 11/11/2014
• Est. Priority Date: 02/25/2002
• Status: Active Grant

• Current Assignee: Sequana Medical NV
• Original Assignee: Sequana Medical AG (Sequana Medical NV)
• Inventors: Burnett, Daniel R.
• Primary Examiner(s): Wiest, Philip R
• Application Number:
  US13/973,981
• Publication Number:
  US 20130338565A1
• Time in Patent Office: 446 Days
• Field of Search: 604 8- 10, 604 93- 1, 604/64.01, 604/95.01, 604/96.01, 604/104, 604245-247, 604/264, 604/540, 604/544, 604/19, 604/30, 604/48, 604500-508, 604/514, 604/517, 623/301, 623/3.26, 623/3.28, 623/11.11, 623 2364- 2365, 128/898
• US Class Current: 604/9
• CPC Class Codes: A61M 1/28 Peritoneal dialysis ; Other peritoneal treatment, e.g. oxygenation
• CPC Class Codes: A61M 2039/248 Ball-valve
• CPC Class Codes: A61M 2205/103 rotating
• CPC Class Codes: A61M 2205/3331 Pressure; Flow
• CPC Class Codes: A61M 2205/3334 Measuring or controlling the flow rate
• CPC Class Codes: A61M 2205/3355 Controlling downstream pump pressure
• CPC Class Codes: A61M 2205/8206 battery-operated
• CPC Class Codes: A61M 2205/8237 Charging means
• CPC Class Codes: A61M 2205/8287 operated by an external magnetic or electromagnetic field
• CPC Class Codes: A61M 2210/0693 Brain, cerebrum
• CPC Class Codes: A61M 2210/101 Pleural cavity
• CPC Class Codes: A61M 2210/1017 Peritoneal cavity
• CPC Class Codes: A61M 2210/1053 Stomach
• CPC Class Codes: A61M 2210/106 Small intestine
• CPC Class Codes: A61M 2210/1064 Large intestine
• CPC Class Codes: A61M 2210/1085 Bladder
• CPC Class Codes: A61M 2210/122 Pericardium
• CPC Class Codes: A61M 2230/005 Parameter used as control input for the apparatus
• CPC Class Codes: A61M 2230/208 pH-value
• CPC Class Codes: A61M 2230/50 Temperature
• 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
• CPC Class Codes: A61M 27/006 : Cerebrospinal drainage; Accessories therefor, e.g. valves
• CPC Class Codes: A61M 39/24 : Check- or non-return valves
• CPC Class Codes: A61M 5/14276 : specially adapted for implantation
• CPC Class Codes: A61M 5/1723 : using feedback of body parameters, e.g. blood-sugar, pressure measurement of body parameters A61B5/00

Abstract

An implantable fluid management device, designed to drain excess fluid from a variety of locations in a living host into a second location within the host, such as the bladder of that host. The device may be used to treat ascites, chronic pericardial effusions, normopressure hydrocephalus, hydrocephalus, pulmonary edema, or any fluid collection within the body of a human, or a non-human mammal.

Claims

1. An implantable fluid management system comprising:

an implantable pump having an inlet, an outlet, an electromechanical motor and an integrated controller, the implantable pump configured to be implanted subcutaneously;

a first tube coupled between a pleura and the inlet;

a second tube coupled between the outlet and an abdomen; and

a sensor disposed in fluid communication with at least one of the first and second tubes and operatively coupled to the controller,

wherein the integrated controller is programmed to activate the electromechanical motor to pump fluid from the pleura to the abdomen at predetermined intervals when the sensor detects a fluid parameter in the pleura higher than a predetermined threshold.

2. The system of claim 1, wherein the implantable pump further comprises an external control module configured to be periodically coupled to the implantable pump to transfer energy to the implantable pump.

3. The system of claim 2, wherein the external control module comprises a driveshaft and a magnet holding arm, the driveshaft transferring power to the magnet holding arm.

4. The system of claim 1, wherein the predetermined intervals are adjustable.

5. The system of claim 1, wherein the abdomen comprises a bladder,

wherein the second tube is coupled between the outlet and the bladder, and

wherein the integrated controller is programmed to activate the electromechanical motor to pump fluid from the pleura to the bladder.

6. The system of claim 1, wherein the implantable pump further comprises a housing made of a biocompatible material.

7. The system of claim 6, wherein the housing comprises anchors selected from the group consisting of barbed insertion pins, a screw threading defined on an outside surface of the implantable pump, staples, sutures, adhesive compounds, a porous solid promoting interstitial cell growth, one or more pins designed to be inserted into the abdominal wall, and combinations thereof.

8. The system of claim 6, wherein the housing comprises a material promoting fibrotic ingrowth into the housing, and

wherein one or more anti-infective coatings are provided on the housing.

9. The system of claim 1, wherein the sensor comprises a first pressure sensor disposed at an end of the first tube, and

further comprising a second pressure sensor disposed at an end of the second tube.

10. The system of claim 1, wherein the implantable pump and integrated controller are configured to be remotely activated.

11. The system of claim 2, wherein the external control module transfers data with the implantable pump.

12. The system of claim 1, wherein the implantable pump further comprises a battery.

13. A method of removing fluid from a pleura, the method comprising:

subcutaneously implanting a pump, a first tube, a second tube, and a sensor such that the first tube is coupled between the pleura and an inlet of the pump, the second tube is coupled between an abdomen and an outlet of the pump, and the sensor is disposed in fluid communication with at least one of the first and second tubes; and

activating the pump to pump fluid from the pleura to the abdomen at predetermined intervals responsive to the sensor detecting a fluid parameter in the pleura higher than a predetermined threshold.

14. The method of claim 13, wherein the pump further comprises an external control module configured to be periodically coupled to the pump to transfer energy to the pump.

15. The method of claim 13, wherein the predetermined intervals are adjustable.

16. The method of claim 13, wherein the abdomen comprises a bladder, wherein the second tube is coupled between the bladder and the outlet of the pump, and wherein the activating comprises activating the pump to pump fluid from the pleura to the bladder.

17. The method of claim 13, wherein the activating comprises activating the pump to pump fluid from the pleura to the abdomen at the predetermined intervals responsive to the sensor detecting a pressure in the abdomen lower than the predetermined threshold.

18. The method of claim 13, wherein activating the pump comprises remotely activating the pump.

19. The method of claim 13, wherein the pump further comprises an external control module configured to be periodically coupled to the pump to transfer data therebetween.

20. The method of claim 13, wherein the pump further comprises a battery.