Apparatus and methods for treating intracorporeal fluid accumulation

• US 9,149,613 B2
• Filed: 02/15/2012
• Issued: 10/06/2015
• Est. Priority Date: 02/16/2011
• Status: Active Grant

• Current Assignee: Sequana Medical NV
• Original Assignee: Sequana Medical AG (Sequana Medical NV)
• Inventors: Degen, Thomas Werner, Thommen, Daniel Thomas, Johnson, Noel L.
• Primary Examiner(s): Zalukaeva, Tatyana
• Assistant Examiner(s): WENG, KAI H
• Application Number:
  US13/397,509
• Publication Number:
  US 20120209165A1
• Time in Patent Office: 1,329 Days
• Field of Search: 604/9, 604/29
• US Class Current: 1/1
• CPC Class Codes: A61M 1/28 Peritoneal dialysis ; Other peritoneal treatment, e.g. oxygenation
• CPC Class Codes: A61M 2205/10 with powered movement mechanisms
• CPC Class Codes: A61M 2205/3368 Temperature
• CPC Class Codes: A61M 2205/3379 Masses, volumes, levels of fluids in reservoirs, flow rates
• CPC Class Codes: A61M 2205/3507 with implanted devices, e.g. external control
• CPC Class Codes: A61M 2205/3569 sublocal, e.g. between console and disposable
• CPC Class Codes: A61M 2205/502 User interfaces, e.g. screens or keyboards
• CPC Class Codes: A61M 2205/52 with memories providing a history of measured variating parameters of apparatus or patient
• CPC Class Codes: A61M 2205/8243 by induction
• CPC Class Codes: A61M 2230/005 Parameter used as control input for the apparatus
• CPC Class Codes: A61M 2230/42 Rate
• 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 5/14236 Screw, impeller or centrifugal type pumps
• CPC Class Codes: A61M 5/14276 specially adapted for implantation
• CPC Class Codes: G16H 20/17 delivered via infusion or injection
• CPC Class Codes: G16H 40/63 for local operation

Abstract

A fluid management system for the treatment of ascites, pleural effusion or pericardial effusion is provided including an implantable device including a pump, control circuitry, battery and transceiver; a charging and communication system configured to periodically charge the battery and communicate with the implantable device to retrieve performance data; and monitoring and control software, suitable for use with conventional personal computers, for configuring and controlling operation of the implantable device and charging and communication system. The implantable device includes a number of features that provide automated movement of fluid to the bladder with reduced risk of clogging, with no patient involvement other than occasional recharging of the battery of the implantable device. The monitoring and control software is available only to the treating physician, such that the physician interacts with the implantable device via the charging and communication system.

Claims

1. A fluid management system comprising:

an implantable device comprising a housing containing a positive displacement gear pump coupled to an electric motor and a first controller coupled to a first battery, a first transceiver, and a first inductive charging circuit;

an external charging and communication system comprising a housing, a second controller coupled to a second transceiver and a second inductive charging circuit, the charging and communication system configured to wirelessly communicate transcutaneously with the implantable device via the first and second transceivers, and to wirelessly transfer energy transcutaneously from the second inductive circuit to the first inductive circuit to charge the first battery;

a non-transitory computer readable medium programmed with instructions that, when run on a computer, cause the computer to communicate operational parameters to the implantable device via the charging and communication system to control operation of the motor and gear pump;

wherein the first controller is programmed to automatically activate the motor and gear pump to move fluid during predetermined time periods and in predetermined volumes responsive to operational parameters communicated by the computer.

2. The fluid management system of claim 1 wherein the housing of the charging and communication system further comprises:

a handpiece configured to house the second controller, the second transceiver, the second inductive charging circuit and a second battery; and

a base configured to contain circuitry for charging the second battery.

3. The fluid management system of claim 1 wherein the second inductive circuit includes a coil, and the handpiece is configured to facilitate externally positioning the handpiece in alignment with the implantable device.

4. The fluid management system of claim 1 further comprising:

an inflow catheter having an inlet end and an outlet end configured to be coupled to the gear pump;

an outflow catheter having an inlet end configured to be coupled to the gear pump and an outlet end configured to be positioned in a sink cavity,

wherein the first controller is programmed to activate the gear pump to move fluid from the inlet end of the inflow catheter to the sink cavity.

5. The fluid management system of claim 4 wherein the inlet end of the inflow end is configured to be positioned within a peritoneal cavity, the outlet end of the outflow catheter is configured to be positioned within a bladder and the first controller is programmed to activate the gear pump to move ascites from the peritoneal cavity to the bladder.

6. The fluid management system of claim 4 wherein the inlet end of the inflow end is configured to be positioned within a pleural cavity, the outlet end of the outflow catheter is configured to be positioned within either a bladder or a peritoneal cavity, and the first controller is programmed to activate the gear pump to move excess fluid from the pleural cavity to the bladder or the peritoneal cavity.

7. The fluid management system of claim 4 wherein the inlet end of the inflow end is configured to be positioned within a pericardial cavity, the outlet end of the outflow catheter is configured to be positioned within either a bladder or a peritoneal cavity, and the first controller is programmed to activate the gear pump to move excess fluid from the pericardial cavity to the bladder or the peritoneal cavity.

8. The fluid management system of claim 1 wherein the first controller is programmed to automatically activate the motor and gear pump to move fluid at high flow rates during pumping, and thereby clean the inflow and outflow catheters to reduce the risk of clogging.

9. The fluid management system of claim 1 wherein the first controller is programmed to periodically activate the motor and gear pump in a tick mode to reduce potential clogging, substantially without moving fluid through the outflow catheter.

10. The fluid management system of claim 1 wherein the first controller is programmed to operate the motor and gear pump in a boost mode to unblock the gear pump, wherein additional energy to drive the motor is transferred to the first inductive circuit via the second inductive circuit of the charging and communication system.

11. The fluid management system of claim 1 wherein the first controller is programmed to operate the motor and gear pump in a jog mode to unblock the gear pump, wherein the motor is rapidly alternated between forward and reverse directions.

12. The fluid management system of claim 1 wherein the motor includes a splined shaft, the gear pump includes a gear having keyed opening, and the splined shaft floats within the keyed opening.

13. The fluid management system of claim 4 wherein the implantable device further comprises a first pressure sensor configured to measure inflow catheter pressure and a second pressure sensor configured to measure outflow catheter pressure.

14. The fluid management system of claim 13 wherein the implantable device further comprises a third pressure sensor configured to measure ambient pressure, and the first controller is programmed to activate the motor and gear pump responsive to differences between inflow catheter pressure and ambient pressure, and outflow catheter pressure and ambient pressure.

15. The fluid management system of claim 4 wherein the implantable device further comprises at least one valve that prevents reverse flow from the outflow catheter to the inflow catheter.

16. The fluid management system of claim 15 wherein the valve is interposed between two pressure sensors, such that a flow rate may be computed by measuring a pressure drop across the valve.

17. The fluid management system of claim 4 further comprising an accelerometer disposed within the implantable device and coupled to the first controller, the first controller programmed to prevent activation of the motor and gear pump if the accelerometer indicates that a patient is asleep.

18. The fluid management system of claim 1 wherein the implantable device further comprises a temperature sensor coupled to the first controller to generate a temperature value, the second controller programmed to retrieve the temperature value from the implantable device while wirelessly transferring energy from the second inductive circuit to the first inductive circuit to charge the first battery.

19. The fluid management system of claim 1 wherein the second controller is programmed to alternate wirelessly transferring energy from the second inductive circuit to the first inductive circuit between a high power mode and a low power mode to maintain the temperature value less than a predetermined value.

20. The fluid management system of claim 1 wherein the charging and communication system is configured to manually activate the pump and receive test data during a self-prime mode of operation.

21. The fluid management system of claim 1 wherein the charging and communication system is configured to wirelessly download data stored on the implantable device to a memory disposed within the charging and communication system via the first and second transceivers.

22. The fluid management system of claim 21 wherein the instructions cause the computer to periodically communicate with the charging and communication system, using either a wired or wireless connection, to retrieve data stored in the memory.

23. The fluid management system of claim 1 wherein the instructions cause the computer to upload revised firmware for the first controller via the charging and communication system using the first and second transceivers.

24. The fluid management system of claim 1, wherein the implantable device further comprises a sensor configured to measure at least one of respiratory rate, fluid temperature, and fluid viscosity, and

wherein the instructions cause the computer to predict or detect infection based on an increase in at least one of the measured respiratory rate, fluid temperature, or fluid viscosity above a predefined threshold, and to visually display to a user to the prediction or detection of infection.