Methods of using a fluid management system

• US 9,956,336 B2
• Filed: 11/11/2013
• Issued: 05/01/2018
• 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): Eisenberg, Rebecca E
• Application Number:
  US14/077,005
• Publication Number:
  US 20140066841A1
• Time in Patent Office: 1,632 Days
• 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. A method of using a fluid management system with a patient having a peritoneum and a bladder, the method comprising:

introducing a peritoneal dialysis fluid from a reservoir to the patient'"'"'s peritoneum;

pumping, using an implantable device, the peritoneal dialysis fluid in the peritoneum to the patient'"'"'s bladder via a peritoneal catheter and a bladder catheter;

transferring data from the implantable device to a charging and communication system external to the patient;

providing the data from the charging and communication system to monitoring and control software running on a computer separate from the charging and communication system; and

communicating operational parameters from the monitoring and control software to the implantable device via the charging and communication system to control the pumping.

2. The method of claim 1, wherein the implantable device comprises a housing containing a positive displacement gear pump coupled an electric motor and a first controller coupled to a battery, a first transceiver, and a first inductive charging circuit.

3. The method of claim 2, wherein the charging and communication system comprises a second controller coupled to a second transceiver and a second inductive charging circuit and wherein the charging and communication system is configured to wirelessly transfer the data with the implantable device via the first and second transceivers,

the method further comprising wirelessly transferring energy from the second inductive circuit to the first inductive circuit to charge the battery.

4. The method of claim 1, wherein the reservoir is configured for external use.

5. The method of claim 4, wherein introducing the peritoneal dialysis fluid further comprises introducing the peritoneal dialysis fluid from the reservoir to the patient'"'"'s peritoneum using an external pump.

6. The method of claim 4, further comprising providing a belt configured to secure the reservoir to the patient'"'"'s body.

7. The method of claim 6, wherein the reservoir comprises at least one pouch arranged along the length of the belt.

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

9. The method of claim 1, wherein the data comprises measurements of at least one of:

respiratory rate, fluid temperature, fluid viscosity, fluid pressure in the peritoneum, or fluid pressure in the bladder measured by at least one sensor coupled to the implantable device.

10. The method of claim 1, wherein transferring the data comprises wirelessly downloading the data stored on the implantable device to a memory disposed within the charging and communication system.

11. The method of claim 10, wherein providing the data comprises periodically communicating via the monitoring and control software with the charging and communication system, using either a wired or wireless connection, to retrieve the data stored in the memory.

12. The method of claim 1, further comprising:

detecting a change in the patient'"'"'s health based on an increase in at least one of a measured respiratory rate, fluid temperature, or fluid viscosity above a predefined threshold; and

displaying information about the detected change in the patient'"'"'s health on a display of the computer.

13. The method of claim 12, further comprising:

modifying the operational parameters of the implantable device based on the detected change in the patient'"'"'s health; and

communicating the modified operational parameters from the monitoring and control software to the implantable device via the charging and communication system.

14. The method of claim 13, 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, or a frequency with which peritoneal dialysis fluid is removed from the patient'"'"'s peritoneum to the bladder.

15. The method of claim 12, wherein the detected change in the patient'"'"'s health is an infection or a change in liver function.

16. The method of claim 1, further comprising exposing the peritoneal dialysis fluid to light from a UV lamp for a sufficient amount of time to inhibit the growth of colonies of one or more pathogens.

17. The method of claim 1, wherein the method is for treating liver failure.

18. The method of claim 1, wherein the pumping comprises moving the fluid during predetermined time periods and in predetermined volumes responsive to the operational parameters communicated by the monitoring and control software.

19. The method of claim 1, further comprising operating the implantable device in a tick mode to reduce potential clogging, substantially without moving fluid.

20. The method of claim 1, further comprising rapidly alternating a motor of the implantable device between forward and reverse directions to unblock a gear pump of the implantable device.

21. The method of claim 1, wherein the peritoneal dialysis fluid comprises albumin.