Implantable fluid management system for the removal of excess fluid

• US 7,621,886 B2
• Filed: 07/13/2005
• Issued: 11/24/2009
• Est. Priority Date: 02/25/2002
• Status: Active Grant

• Current Assignee: Sequana Medical NV
• Original Assignee: NovaShunt AG (Sequana Medical NV)
• Inventors: Burnett, Daniel R.
• Primary Examiner(s): Deak; Leslie R
• Assistant Examiner(s): Wiest; Philip R.
• Application Number:
  US11/181,539
• Publication Number:
  US 20050273034A1
• Time in Patent Office: 1,595 Days
• Field of Search: 604/890.1, 604/891.1, 604 7- 10, 604/93.01, 604/94.01, 604/95.01, 604/96.01, 604/104, 604245-247, 604/264, 604/540, 604/544, 604/19, 604/48, 604/30, 604/500, 604/507, 604/508, 604/514, 604/517, 604/131, 604/151, 604/541, 604/164.01, 604/164.11, 604/317, 604/118, 604/323, 623/3.1, 623/3.26, 623/3.28, 623/11.11, 623 2364- 2365, 623/66.1, 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. A method of draining a fluid from a patient'"'"'s peritoneal cavity to the patient'"'"'s bladder, the method comprising:

implanting within the patient'"'"'s peritoneal cavity an apparatus comprising an electromechanical pump, a battery and a programmable controller coupled to the electromechanical pump and the battery, the electromechanical pump including an inlet and an outlet;

establishing fluid communication between the peritoneal cavity and the inlet with a first tube and between the outlet and the bladder with a second tube; and

periodically activating the electromechanical pump, responsive to the programmable controller, in an oscillating or pulsatile manner to jar proteinaceous buildup free from within the pump and the first and second tubes to prevent clogging.

2. The method of claim 1, further comprising activating the electromechanical pump, responsive to the programmable controller, to attain a predetermined drainage per day of fluid from the peritoneal cavity to the bladder.

3. The method of claim 1, wherein the apparatus further comprises a sensor coupled to the programmable controller, the method further comprising controlling activation of the electromechanical pump responsive to an output of the sensor.

4. The method of claim 3, further comprising preventing activation of the electromechanical pump when a sensor senses a specific circumstance.

5. The method of claim 4, wherein the sensor is configured to sense a fluid pressure within the bladder, the method further comprising Preventing activation of the electromechanical pump by the programmable controller when the output of the sensor indicates that the bladder is at a pressure exceeding a predetermined pressure.

6. The method of claim 3, further comprising activating the electromechanical pump when a sensor senses a specific circumstance.

7. The method of claim 6, wherein the sensor is configured to sense a fluid pressure within the peritoneal cavity, the method further comprising activating the electromechanical pump when the output of the sensor indicates that the peritoneal cavity is at a pressure exceeding a predetermined threshold.

8. The method of claim 1, wherein the electromechanical pump further comprises first and second gear elements that rotate in opposite directions, wherein the method further comprises activating the electromechanical pump so as to cancel torques generated by the first and second gear elements.

9. The method of claim 1, further comprising communicating information related to a pump function to an external source.

10. The method of claim 1, further comprising programming a pump function of the programmable controller from an external source.

11. The method of claim 1, wherein the battery is recharged wirelessly, the method further comprising recharging the battery via a magnetic coupling.

12. The method of claim 1, further comprising providing means for anchoring the electromechanical pump to bodily tissue.

13. An apparatus for draining a fluid from a patient'"'"'s peritoneal cavity to the patient'"'"'s bladder, the apparatus comprising:

a housing configured for subcutaneous implantation;

an electromechanical pump disposed within the housing, the pump having an inlet and an outlet;

a first tube having a first end configured to be disposed within the peritoneal cavity and a second end coupled to the inlet;

a second tube having a first end coupled to the outlet and a second end configured to be coupled to the bladder;

a battery disposed within the housing; and

a controller disposed within the housing, the controller coupled to the electromechanical pump and the battery, the controller programmed to periodically activate the electromechanical pump in an oscillating or pulsatile manner to jar proteinaceous buildup free from within the electromechanical pump and the first and second tubes to prevent clogging.

14. The apparatus of claim 13, wherein the controller is programmed to activate the electromechanical pump to attain a maximum drainage per day of fluid from the peritoneal cavity to the bladder.

15. The apparatus of claim 13, further comprising a sensor coupled to the controller, the controller programmed to activate the electromechanical pump responsive to an output of the sensor.

16. The apparatus of claim 15, wherein the controller is programmed to prevent activation of the electromechanical pump when the sensor senses a specific circumstance.

17. The apparatus of claim 16, wherein the sensor is configured to sense a fluid pressure within the peritoneal cavity and the controller is programmed to activate the electromechanical pump when the output of the sensor indicates that the peritoneal cavity is at a pressure exceeding a predetermined threshold.

18. The apparatus of claim 15, wherein the controller is programmed to activate the electromechanical pump when the sensor senses a specific circumstance.

19. The apparatus of claim 13, wherein the electromechanical pump comprises first and second gear elements configured to rotate in opposite directions so as to cancel torques generated by the first and second gear elements.

20. The apparatus of claim 19, wherein the sensor is configured to sense a fluid pressure within the bladder and the controller is programmed to prevent activation of the electromechanical pump when the output of the sensor indicates that the bladder is at a pressure exceeding a predetermined pressure.

21. The apparatus of claim 13, wherein the controller is configured to communicate information related to a pump function to an external source.

22. The apparatus of claim 13, wherein a pump function of the controller is configured to be programmed from an external source.

23. The apparatus of claim 13, wherein the battery is configured to be recharged wirelessly via a magnetic coupling.

24. The apparatus of claim 13, further comprising means for anchoring the electromechanical pump to bodily tissue.