Implantable fluid management system for the removal of excess fluid

• US 9,913,968 B2
• Filed: 07/27/2016
• Issued: 03/13/2018
• 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:
  US15/220,812
• Publication Number:
  US 20160331947A1
• Time in Patent Office: 594 Days
• Field of Search: 604 8, 604 9, 417417, 4174104
• 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 comprising a gear pump and an integrated controller, the gear pump having an inlet and an outlet;

a first tube coupled between a peritoneal cavity and the inlet;

a second tube coupled between the outlet and a second body cavity; and

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

wherein the integrated controller is programmed to activate the gear pump to pump fluid from the peritoneal cavity to the second body cavity when the sensor detects a fluid parameter in the peritoneal cavity or the second body cavity higher or lower than a predetermined threshold.

2. The system of claim 1, further comprising 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 1, wherein the integrated controller is further programmed to activate the gear pump to pump fluid from the peritoneal cavity to the second body cavity at predetermined intervals.

4. The system of claim 1, wherein the second body cavity comprises a bladder, a stomach, a small intestine, or a large intestine,

wherein the second tube is coupled between the outlet and the bladder, the stomach, the small intestine, or the large intestine, and

wherein the integrated controller is programmed to activate the gear pump to move fluid from the peritoneal cavity to the bladder, the stomach, the small intestine, or the large intestine.

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

6. The system of claim 5, 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.

7. The system of claim 5, 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.

8. The system of claim 1, wherein the fluid parameter detected by the sensor is fluid pressure or fluid flow.

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

10. 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.

11. The system of claim 2, wherein the external control module is configured to transfer 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 peritoneal cavity, the method comprising:

detecting, with a sensor, a fluid parameter in the peritoneal cavity or a second body cavity higher or lower than a predetermined threshold; and

activating an implantable pump comprising a gear pump and an integrated controller to pump fluid from the peritoneal cavity through a first tube coupled between the peritoneal cavity and an inlet of the gear pump, through a second tube coupled between the second body cavity and an outlet of the gear pump, and into the second body cavity,

wherein activating the implantable pump comprises activating the implantable pump to pump fluid from the peritoneal cavity to the second body cavity responsive to detecting the fluid parameter higher or lower than the predetermined threshold.

14. The method of claim 13, further comprising periodically coupling the implantable pump to an external control module to transfer energy to the implantable pump.

15. The method of claim 13, further comprising activating the implantable pump to pump fluid from the peritoneal cavity to the second body cavity at predetermined intervals.

16. The method of claim 13, wherein the second body cavity comprises a bladder, a stomach, a small intestine, or a large intestine, and

wherein the second tube is coupled between the outlet of the pump and the bladder, the stomach, the small intestine, or the large intestine, and

wherein the activating comprises activating the implantable pump to pump fluid from the peritoneal cavity to the bladder, the stomach, the small intestine, or the large intestine.

17. The method of claim 13, wherein the fluid parameter detected by the sensor is fluid pressure or fluid flow.

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

19. The method of claim 13, further comprising periodically coupling the implantable pump to an external control module to transfer data therebetween.

20. The method of claim 13, wherein the implantable pump further comprises a battery, the method further comprising periodically recharging the battery.