Apparatus and methods for treating intracorporeal fluid accumulation

• US 10,252,037 B2
• Filed: 10/02/2015
• Issued: 04/09/2019
• 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): Weng, Kai H
• Application Number:
  US14/874,187
• Publication Number:
  US 20160022971A1
• Time in Patent Office: 1,285 Days
• Field of Search: 604 9, 604 29
• 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 inflow catheter comprising an inlet end and an outlet end;

an outflow catheter comprising an inlet end and an outlet end adapted to be positioned in a sink cavity;

an implantable pump coupled to the outlet end of the inflow catheter and the inlet end of the outflow catheter, the implantable pump comprising a housing containing at least one sensor, a positive displacement gear pump coupled to an electric motor and a controller coupled to a battery, the controller programmed to automatically activate the motor and gear pump to move fluid from the inlet end of the inflow catheter to the sink cavity responsive to operational parameters stored at the controller; and

a non-transitory computer readable medium programmed with instructions that, when run on a computer, cause a graphical user interface of the computer to visually display information indicative of status of the implantable pump, including a volume of fluid pumped via a session volume window, a measured pressures window, a patient parameters window, and an alarm condition window, the information wirelessly transmitted from the implantable pump to the computer, the computer readable medium further configured to store adjusted operational parameters responsive to user input,

wherein the at least one sensor is configured to sense movement of the positive displacement gear pump to generate a signal indicative of the sensed movement such that the instructions, when run on the computer, cause the graphical user interface to visually display the volume of fluid pumped based on the signal from the at least one sensor.

2. The fluid management system of claim 1, wherein the information comprises at least one of respiratory rates fluid temperature, fluid viscosity, volume of fluid pumped at predetermined intervals, pressure, and battery status.

3. The fluid management system of claim 1, wherein the computer readable medium is further configured to cause the computer to wirelessly transmit the adjusted operational parameters to the implantable pump to control operation of the motor and gear pump responsive to the adjusted operational parameters.

4. The fluid management system of claim 1, wherein the operational parameters are selectively adjustable by a physician responsive to the information indicative of status of the implantable pump.

5. The fluid management system of claim 1, wherein the implantable pump further comprises a first transceiver and a first inductive charging circuit.

6. The fluid management system of claim 5, further comprising 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 pump via the first and second transceivers, and to wirelessly transfer energy transcutaneously from the second inductive to the first inductive circuit to charge the battery.

7. The fluid management system of claim 6, wherein the computer is configured to wirelessly communicate with the implantable pump via the external charging and communication system.

8. The fluid management system of claim 6, 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.

9. The fluid management system of claim 1, wherein the inlet end of the inflow catheter is adapted to be positioned within one of a peritoneal cavity, a pleural cavity, or a pericardial cavity, and the sink cavity is configured to be one of a bladder or the peritoneal cavity.

10. The fluid management system of claim 1, further comprising a first pressure sensor configured to measure inflow catheter pressure and a second pressure sensor configured to measure outflow catheter pressure.

11. The fluid management system of claim 10, further comprising a third pressure sensor configured to measure ambient pressure,

wherein the controller is further 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.

12. The fluid management system of claim 1, further comprising at least one valve that prevents reverse flow from the outflow catheter to the inflow catheter.

13. The fluid management system of claim 12, 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.

14. The fluid management system of claim 1, further comprising an accelerometer disposed within the implantable pump and coupled to the controller, the controller programmed to prevent activation of the motor and gear pump if the accelerometer indicates that a patient is asleep.

15. The fluid management system of claim 1, wherein the implantable pump is configured to operate in a self-prime mode wherein feedback is provided based on whether a pumping session is successful or not.

16. The fluid management system of claim 1, wherein the operational parameters comprise at least one of a minimum pressure at the inflow catheter, a minimum pressure at the outflow catheter, a maximum pressure at the inflow catheter, a maximum pressure at the outflow catheter, a maximum temperature differential during charging, times when the implantable pump may and may not operate, a target daily volume of fluid to transport, volume of fluid to be transported per pumping session, a maximum volume to be pumped, a minimum volume to be pumped, motor speed, duration per pumping session, and motor voltage.

17. A method for treating intracorporeal fluid accumulation, the method comprising:

storing operational parameters at a controller of an implantable pump, the implantable pump comprising a housing containing at least one sensor and a positive displacement gear rump;

pumping fluid from an inflow catheter coupled to the implantable pump to an outflow catheter coupled to the implantable pump responsive to the stored operation parameters;

generating using the at least one sensor, a signal indicative of movement of the positive displacement gear pump;

determining a volume of fluid pumped based on the signal;

displaying information indicative of status of the implantable pump, including the volume of fluid pumped via a session volume window, a measured pressures window, a patient parameters window, and an alarm condition window, the information based on status information data;

wirelessly transmitting adjusted operation parameters from the computer to the implantable pump;

storing the adjusted operational parameters at the controller of the implantable pump; and

pumping fluid from the inflow catheter to the outflow catheter responsive to the stored adjusted operation parameters.

18. The method of claim 17, wherein wirelessly transmitting the status information data from the implantable pump to the computer comprises wirelessly transmitting the status information data from the implantable pump to the computer via an external charging and communication system, and

wherein wirelessly transmitting the adjusted operation parameters from the computer to the implantable pump comprises wirelessly transmitting the adjusted operation parameters from the computer to the implantable pump via the external charging and communication system.

19. The method of claim 17, wherein the information comprises at least one of respiratory rate, fluid temperature, fluid viscosity, volume of fluid pumped at predetermined intervals, pressure, and battery status.

20. The method of claim 17, wherein an in let end of the inflow catheter is adapted to be positioned within one of a peritoneal cavity, a pleural cavity, or a pericardial cavity, and an outlet end of the outflow catheter is adapted to be positioned within one of a bladder or a peritoneal cavity.

21. The method of claim 17, wherein the operational parameters comprise at least one of a minimum pressure at the inflow catheter, a minimum pressure at the outflow catheter, a maximum pressure at the inflow catheter, a maximum pressure at the outflow catheter, a maximum temperature differential during charging, times when the implantable pump may and may not operate, a target daily volume of fluid to transport, volume of fluid to be transported per pumping session, a maximum volume to be pumped, a minimum volume to be pumped, motor speed, duration per pumping session, and motor voltage.