Systems and methods for fluid management

• US 10,569,003 B2
• Filed: 04/27/2018
• Issued: 02/25/2020
• Est. Priority Date: 02/15/2012
• Status: Active Grant

• Current Assignee: Sequana Medical NV
• Original Assignee: Sequana Medical NV
• Inventors: Degen, Thomas Werner, Thommen, Daniel Thomas, Johnson, Noel L.
• Primary Examiner(s): Eisenberg, Rebecca E
• Application Number:
  US15/965,727
• Publication Number:
  US 20180243495A1
• Time in Patent Office: 669 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

A system includes 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 fluid management system for use with a patient having a peritoneal cavity and a bladder, the system comprising:

a peritoneal catheter comprising a first end and a second end configured to be implanted in the peritoneal cavity;

a bladder catheter comprising a first end and a second end configured to be implanted in the bladder;

an implantable pump coupled to the first end of the peritoneal catheter and coupled to the first end of the bladder catheter, the implantable pump comprising a housing containing a first processor, and a battery, the implantable pump further comprising a first inductive circuit coupled to the battery, the first processor configured to cause the implantable pump to pump fluid, introduced into the peritoneal cavity from a reservoir, to the bladder via the peritoneal catheter and the bladder catheter;

an external charging and communication system comprising a second inductive circuit, the external charging and communication system configured to wirelessly communicate with the implantable pump and to wirelessly transfer energy from the second inductive circuit to the first inductive circuit of the implantable pump to charge the battery; and

a non-transitory computer readable medium having instructions stored thereon, wherein the instructions, when executed by a second processor of an external computer separate from the external charging and communication system, cause the external computer to communicate operational parameters to the implantable pump via the charging and communication system to control operation of the implantable pump.

2. The fluid management system of claim 1, wherein the implantable pump is configured for use with the reservoir designed for external use.

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

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

5. The fluid management system of claim 4, wherein the implantable pump is configured for use with the reservoir that comprises at least one pouch arranged along the length of the belt.

6. The fluid management system of claim 2, further comprising a reservoir catheter configured to be coupled to the reservoir and to the implantable pump, the implantable pump further configured to pump the fluid from the reservoir to the patient'"'"'s peritoneal cavity via the reservoir catheter.

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

8. The fluid management system of claim 1, further comprising the reservoir, wherein the reservoir is configured for internal implantation and comprises a port configured to receive fresh fluid.

9. The fluid management system of claim 8, further comprising a reservoir catheter coupled to the reservoir and to the implantable pump, the implantable pump further being configured to pump the fluid from the reservoir to the patient'"'"'s peritoneal cavity via the reservoir catheter.

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

11. The fluid management system of claim 1, wherein the implantable pump further comprises a first transceiver, and wherein the charging and communication system further comprises:

a handpiece housing a third processor, a second transceiver, the second inductive circuit, and a second battery; and

a base containing circuitry for charging the second battery.

12. The fluid management system of claim 11, wherein the second inductive circuit includes a coil, and the handpiece is configured to facilitate externally positioning the handpiece in alignment with the implantable pump.

13. The fluid management system of claim 1, wherein the first processor is programmed to automatically activate a motor and a gear pump within the housing of the implantable pump to move fluid during predetermined time periods and in predetermined volumes responsive to operational parameters communicated by the external computer.

14. The fluid management system of claim 13, wherein the first processor is programmed to automatically activate the motor and gear pump to move fluid at high flow rates during pumping, and thereby clean the peritoneal catheter to reduce the risk of clogging.

15. The fluid management system of claim 1, wherein the first processor is programmed to periodically activate the implantable pump in a tick mode to reduce potential clogging, substantially without moving fluid through the bladder catheter.

16. The fluid management system of claim 1, wherein the first processor is programmed to operate the implantable pump in a jog mode to unblock gears within the housing of the implantable pump, wherein a motor of the implantable pump is rapidly alternated between forward and reverse directions.

17. The fluid management system of claim 1, wherein the fluid is dialysate.

18. The fluid management system of claim 17, wherein the dialysate comprises albumin.

19. The fluid management system of claim 1, wherein the implantable pump further comprises sensors configured to measure fluid pressure in the peritoneal cavity and fluid pressure in the bladder, the implantable pump being configured to store data on memory corresponding to measurements made by the sensors.

20. The fluid management system of claim 19, wherein the charging and communication system is configured to wirelessly download the data stored on the implantable pump to a memory disposed within the charging and communication system.

21. The fluid management system of claim 20, wherein the instructions, when executed by the second processor of the external computer, cause the external computer to periodically communicate with the charging and communication system, using either a wired or wireless connection, to retrieve the data stored in the memory.

22. The fluid management system of claim 21, wherein the instructions, when executed by the second processor of the external computer, cause the external computer to detect a change in the patient'"'"'s health and to visually display to a user information about the detected change in the patient'"'"'s health.

23. The fluid management system of claim 22, wherein the instructions, when executed by the second processor of the external computer, cause the external computer to modify operational parameters of the implantable pump based on the detected change in the patient'"'"'s health.

24. The fluid management system of claim 23, wherein the modified operational parameters include at least one of:

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