Systems and methods for treating chronic liver failure based on peritoneal dialysis

• US 8,585,635 B2
• Filed: 02/15/2012
• Issued: 11/19/2013
• Est. Priority Date: 02/15/2012
• 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): Lucchesi, Nicholas
• Assistant Examiner(s): Eisenberg, Rebecca E
• Application Number:
  US13/397,498
• Publication Number:
  US 20130211322A1
• Time in Patent Office: 643 Days
• Field of Search: 604/29
• US Class Current: 604/29
• CPC Class Codes: A61M 1/1676 containing proteins, e.g. albumin
• CPC Class Codes: A61M 1/28 Peritoneal dialysis ; Other peritoneal treatment, e.g. oxygenation
• CPC Class Codes: A61M 1/285 Catheters therefor
• CPC Class Codes: A61M 1/287 Dialysates therefor
• CPC Class Codes: A61M 2205/04 implanted
• CPC Class Codes: A61M 2205/3523 using telemetric means
• CPC Class Codes: A61M 2205/50 with microprocessors or computers
• CPC Class Codes: A61M 2205/52 with memories providing a history of measured variating parameters of apparatus or patient
• CPC Class Codes: A61M 2205/8206 battery-operated
• CPC Class Codes: A61M 2205/8243 by induction
• CPC Class Codes: A61M 2209/088 on the body

Abstract

An artificial liver system for treating liver failure includes a reservoir to provide albumin-containing dialysis fluid to the patient'"'"'s peritoneum, an implantable device including a pump to pump the fluid from the peritoneum to the bladder via respective catheters, control circuitry, battery and transceiver; a charging and communication system configured to periodically charge the battery and communicate with the implantable device to retrieve data reflective of the patient'"'"'s health; 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 monitoring and control software allows a treating physician to remotely adjust the volume, time, and frequency with which fluid is pumped from the peritoneal cavity to the bladder based on the data reflective of the patient'"'"'s health.

Claims

1. An artificial liver system for use with a patient having a peritoneal cavity and a bladder, the system comprising:

a reservoir containing a peritoneal dialysis fluid comprising albumin and configured to provide the peritoneal dialysis fluid to the patient'"'"'s peritoneum;

a peritoneal catheter configured for implantation in the patient'"'"'s peritoneum;

a bladder catheter configured for implantation in the patient'"'"'s bladder;

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, the implantable device being configured to pump the peritoneal dialysis fluid in the peritoneum to the patient'"'"'s bladder via the peritoneal catheter and the bladder catheter;

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

monitoring and control software configured to run on a computer, the monitoring and control software configured to communicate operational parameters to the implantable device via the charging and communication system to control operation of the motor and gear pump.

2. The artificial liver system of claim 1, wherein the reservoir is configured for external use.

3. The artificial liver system of claim 2, further comprising an external pump configured to facilitate flow of the peritoneal dialysis fluid from the reservoir to the patient'"'"'s peritoneum.

4. The artificial liver system of claim 2, further comprising a belt configured to secure the reservoir to the patient'"'"'s body.

5. The artificial liver system of claim 4, wherein the reservoir comprises at least one pouch arranged along the length of the belt.

6. The artificial liver system of claim 2, further comprising a reservoir catheter coupled to the dialysate reservoir and to the implantable device, the pump further being configured to pump the peritoneal dialysis fluid from the reservoir to the patient'"'"'s peritoneum via the reservoir catheter and the peritoneal catheter.

7. The artificial liver system of claim 6, further comprising first and second valves in operable communication with the implantable device, the second valve being configured to be actuated so as to prevent flow from the bladder to the peritoneum when the peritoneal dialysis fluid is pumped from the reservoir to the peritoneum, the first valve being configured to be actuated so as to prevent flow from the peritoneum to the reservoir when the peritoneal dialysis fluid is pumped from the peritoneum to the bladder.

8. The artificial liver system of claim 1, wherein the dialysate reservoir is configured for internal implantation and comprises a port configured to receive fresh peritoneal dialysis fluid.

9. The artificial liver system of claim 8, further comprising a reservoir catheter coupled to the dialysate reservoir and to the implantable device, the pump further being configured to pump the peritoneal dialysis fluid from the reservoir to the patient'"'"'s peritoneum via the reservoir catheter and the peritoneal catheter.

10. The artificial liver system of claim 9, further comprising first and second valves in operable communication with the implantable device, the second valve being configured to be actuated so as to prevent flow from the bladder to the peritoneum when the peritoneal dialysis fluid is pumped from the reservoir to the peritoneum, the first valve being configured to be actuated so as to prevent flow from the peritoneum to the reservoir when the peritoneal dialysis fluid is pumped from the peritoneum to the bladder.

11. The artificial liver system of claim 1, wherein the charging and communication system further comprises:

a handpiece housing the second controller, the second transceiver, the second inductive charging circuit and a second battery; and

a base containing circuitry for charging the second battery.

12. The artificial liver 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.

13. The artificial liver system of claim 1, 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 monitoring and control software.

14. The artificial liver system of claim 13, 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.

15. The artificial liver 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.

16. The artificial liver 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.

17. The artificial liver system of claim 1, wherein the implantable device further comprises sensors configured to measure respiratory rate, fluid temperature, fluid viscosity, fluid pressure in the peritoneum, and fluid pressure in the bladder, the implantable device being configured to store data corresponding to measurements made by the sensors.

18. The artificial liver system of claim 17, wherein the charging and communication system is configured to wirelessly download the data stored on the implantable device to a memory disposed within the charging and communication system via the first and second transceivers.

19. The artificial liver system of claim 18, wherein the monitoring and control software is configured to periodically communicate with the charging and communication system, using either a wired or wireless connection, to retrieve the data stored in the memory.

20. The artificial liver system of claim 19, wherein the monitoring and control software is further configured to detect a change in the patient'"'"'s health 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 information about the detected change in the patient'"'"'s health.

21. The artificial liver system of claim 20, wherein the monitoring and control software is further configured to modify operational parameters of the implantable device based on the detected change in the patient'"'"'s health.

22. The artificial liver system of claim 21, wherein the modified operational parameters include at least one of:

a volume of the peritoneal dialysis fluid, a time period for which the peritoneal dialysis fluid is permitted to remain within the patient'"'"'s peritoneum, and a frequency with which peritoneal dialysis fluid is removed from the patient'"'"'s peritoneum to the bladder.

23. The artificial liver system of claim 20, wherein the detected change in the patient'"'"'s health is an infection or a change in liver function.

24. The artificial liver system of claim 1, wherein the implantable device includes a UV lamp, and wherein the first controller is configured to expose the peritoneal dialysis fluid to light from the UV lamp for a sufficient amount of time to inhibit the growth of colonies of one or more pathogens.