Implantable fluid management system for the removal of excess fluid

• US 8,517,973 B2
• Filed: 02/16/2011
• Issued: 08/27/2013
• 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:
  US13/029,069
• Publication Number:
  US 20110178455A1
• Time in Patent Office: 923 Days
• Field of Search: 604 7- 10, 604/19, 604/30, 604/48, 604/93.01, 604/94.01, 604/95.01, 604/96.01, 604/104, 604245-247, 604/264, 604500-508, 604/514, 604/517, 604/540, 604/544, 623/3.1, 623/3.26, 623/3.28, 623/11.11, 623/23.64, 623/23.65, 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 first pressure sensor disposed in fluid communication with the first tube and operatively coupled to the controller;

a second tube coupled between the outlet and a bladder; and

a second pressure sensor disposed in fluid communication with the second tube 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 bladder responsive to the first pressure sensor detecting a fluid parameter in the pleura exceeding a first predetermined threshold and the second sensor detecting a fluid parameter in the bladder lower than a second 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 2, wherein the external control module transfers the energy to the implantable pump.

5. The system of claim 1, wherein the implantable pump further comprises a housing having anchors.

6. The system of claim 5, wherein the anchors are 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.

7. The system of claim 5, wherein the housing comprises a material promoting fibrotic ingrowth into the housing.

8. The system of claim 5, wherein one or more anti-infective coatings are provided on the housing.

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

10. The system of claim 1, further comprising a housing made of a biocompatible material.

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

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 first pressure sensor, a second tube, and a second pressure sensor such that the first tube is coupled between the pleura and an inlet of the pump, the first pressure sensor is disposed in fluid communication with the first tube, the second tube is coupled between a bladder and an outlet of the pump, and the second pressure sensor is disposed in fluid communication with the second tube;

activating the pump to pump fluid from the pleura to the bladder responsive to the first pressure sensor detecting a fluid parameter in the pleura exceeding a first predetermined threshold and the second sensor detecting a fluid parameter in the bladder lower than a second 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 14, wherein the external control module transfers the energy to the pump.

16. The method of claim 13, wherein the pump further comprises a biocompatible housing having anchors.

17. The method of claim 16, wherein the anchors are 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.

18. The method of claim 16, wherein the housing comprises a material promoting fibrotic ingrowth into the housing.

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

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