Sensing and storage system for fluid balance

• US 10,098,993 B2
• Filed: 12/10/2014
• Issued: 10/16/2018
• Est. Priority Date: 12/10/2014
• Status: Active Grant

• Current Assignee: Mozarc Medical US LLC
• Original Assignee: Medtronic Incorporated (Medtronic Plc)
• Inventors: Meyer, Thomas E., Hajko, William P., Hartranft, Thomas P.
• Primary Examiner(s): Kurtz, Benjamin M
• Application Number:
  US14/566,674
• Publication Number:
  US 20160166748A1
• Time in Patent Office: 1,406 Days
• Field of Search: None
• CPC Class Codes: A61M 1/1601 Control or regulation
• CPC Class Codes: A61M 1/1647 with flow rate measurement of the dialysis fluid, upstream and downstream of the dialyser
• CPC Class Codes: A61M 1/1696 with dialysate regeneration
• CPC Class Codes: A61M 2205/3334 Measuring or controlling the flow rate
• CPC Class Codes: A61M 2205/3365 Rotational speed

Abstract

A sensing and storage system for fluid balance during dialysis is provided. The sensing and storage system has flow sensors on either side of a dialyzer in a controlled volume dialysate flow path. The sensors are positioned so that no fluid can be added to or removed from the dialysate flow path between the sensors except for that which is added or removed by action of a control pump. The sensing and storage system can have a fluid removal line for the removal of fluid from the dialysate flow loop.

Claims

1. A sensing and storage system for fluid balance during dialysis, comprising:

a control pump in a dialysate flow loop in fluid communication with a dialyzer, wherein the dialysate flow loop has a controlled volume;

a fluid removal line fluidly connected to the dialysate flow loop and in communication with the control pump;

an extracorporeal flow loop in fluid communication with the dialysate flow loop across a semi-permeable membrane in the dialyzer;

an inflow sensor in the dialysate flow loop and positioned in the dialysate flow loop at a position before the dialyzer;

an outflow sensor in the dialysate flow loop and positioned in the dialysate flow loop at a position after the dialyzer;

a sensor line having a first end positioned in the dialysate flow loop after the inflow sensor and before the dialyzer and a second end positioned after the outflow sensor wherein the sensor line has one or more additional sensors positioned on the sensor line; and

a control system, wherein the control system controls the outflow sensor and the inflow sensor in electronic communication with the control pump wherein the control pump operates selectively in any one of an influx direction and an efflux direction determined by the outflow sensor and the inflow sensor; and

wherein the control system adjusts a pump rate of one or more pumps making an ultrafiltration flow rate equal to zero and compares a first reading at the inflow sensor to a second reading at the outflow sensor;

wherein if said first and second readings are identical within a predetermined error limit, then the control system sends a signal that dialysis is operating properly.

2. The sensing and storage system of claim 1 wherein the dialysate flow loop is controlled compliant dialysis.

3. The sensing and storage system of claim 1, further comprising at least one fluid pump other than the control pump fluidly connected to a fluid source and in fluid communication with the dialysate flow loop;

wherein the at least one fluid pump other than the control pump is positioned in the dialysate flow loop at a position after the outflow sensor and before the inflow sensor.

4. The sensing and storage system of claim 3 wherein the extracorporeal flow loop has at least one blood pump.

5. The sensing and storage system of claim 3 wherein the at least one fluid pump other than the control pump is selected from the group consisting of a sodium chloride pump in fluid communication with a sodium chloride reservoir, a water pump in fluid communication with a water reservoir, a cation infusate pump in fluid communication with a cation infusate reservoir, a bicarbonate pump in fluid communication with a bicarbonate reservoir, and combinations thereof.

6. The sensing and storage system of claim 1, wherein a fluid removal prescription is set for a patient, and a pump rate of the control pump is automatically adjusted by the control system to remove a prescribed amount of fluid based on inputs from the inflow sensor and the outflow sensor, wherein the adjustment of the pump rate of the control pump is determined by a deviation of the fluid removal prescription from a difference between a first flow rate of dialysate at the inflow sensor and a second flow rate of dialysate at the outflow sensor.

7. The sensing and storage system of claim 1 wherein the control pump is a peristaltic pump.

8. The sensing and storage system of claim 1 wherein the control pump is capable of moving the fluid bi-directionally and wherein the system controls patient net fluid volume by reversing the control pump from the efflux direction to the influx direction.

9. The sensing and storage system of claim 1, further comprising a control reservoir fluidly connected to the fluid removal line.

10. The sensing and storage system of claim 9 wherein the control reservoir has a fluid capacity of between 1 L and 30 L, between 1 L and 3 L, between 3 L and 10 L, between 8 L and 15 L, between 12 L and 20 L, between 15 and 18 L, or between 18 L and 30 L.

11. The sensing and storage system of claim 9 wherein the control reservoir is fluidly connected to a drain, and further comprising a clamp on the control reservoir to control the movement of fluid from the control reservoir to the drain.

12. The sensing and storage system of claim 3, wherein one or more additional flow sensors are provided between the at least one fluid pump and a dialyzer inlet.

13. The sensing and storage system of claim 3, further comprising one or more additional flow sensors positioned between a dialyzer outlet and the at least one fluid pump other than the control pump.

14. A method of controlling fluid removed from a patient during dialysis, comprising the steps of:

obtaining a fluid removal prescription for a patient;

determining the rate of fluid flow in a dialysate flow loop on an inlet side of a dialyzer with the sensing and storage system of claim 1, wherein the dialysate flow loop has a controlled volume;

determining the rate of fluid flow in the dialysate How loop on an outlet side of the dialyzer;

determining the deviation of the fluid removal prescription from the difference in the flow rate on the inlet side of the dialyzer and the flow rate on the outlet side of the dialyzer; and

adjusting the pump rate of the control pump based on the deviation wherein the control pump is capable of moving fluid from the dialysate flow loop into the fluid removal line.

15. The method of claim 14 further comprising adding fluid to the dialysate flow path from any one or more of a control reservoir, a water reservoir, a sodium chloride reservoir, an infusate reservoir, or a bicarbonate reservoir;

wherein the fluid is added at a position in the dialysate flow path located before the inflow sensor and after the outflow sensor.

16. The method of claim 14, wherein the control system automatically adjusts the pump rate of the control pump based on the deviation wherein the control pump is capable of moving fluid from the dialysate flow loop into the fluid removal line.

17. The method of claim 14, further comprising transferring fluid from the dialysate flow path to an extracorporeal circuit to deliver a fluid bolus to a patient.

18. The method of claim 14, further comprising transferring a volume of fluid from the dialysate flow path to the extracorporeal flow loop, wherein transferring the volume of fluid to the extracorporeal flow loop results in blood in the extracorporeal flow loop being returned to a patient.

19. The method of claim 14, wherein the rate of fluid flow in the dialysate flow loop on the inlet side of the dialyzer is determined with the inflow sensor, and the rate of fluid flow in the dialysate flow loop on the outlet side of the dialyzer is determined with the outflow sensor.

20. The method of claim 15, wherein fluid is added to the dialysate flow path from the water reservoir, the sodium chloride reservoir, the infusate reservoir, or the bicarbonate reservoir with the use of one or more fluid pumps.

21. The method of claim 20, further comprising stopping the one or more fluid pumps, determining the rate of flow in the dialysate flow loop on the inlet side of the dialyzer with the inflow sensor, determining the rate of flow in the dialysate flow loop on the outlet side of the dialyzer with the outflow sensor, comparing the rate of flow on the inlet side of the dialyzer to the rate of flow on the outlet side of the dialyzer;

and determining whether the difference between the rate of flow is within a predetermined limit.

22. The sensing and storage system of claim 3, wherein all of the pumps periodically stop for the inflow sensor and the outflow sensor to measure a first flow rate and a second flow rate, respectively.

23. The sensing and storage system of claim 22, wherein the control system stops the dialysis in response to the first flow rate being not identical to the second flow rate within the predetermined error limit.

24. The sensing and storage system of claim 3, wherein the control system adjusts the pump rate of the control pump to a desired value according to the inflow and outflow sensors regardless of the at least one additional fluid pump.

25. The sensing and storage system of claim 1, wherein the control system adjusts the pump rate by temporarily stopping the one or more pumps.

26. The sensing and storage system of claim 1, wherein the control system further comprises one or more of a processor, memory, and computer component for periodic self testing.

27. The sensing and storage system of claim 1, wherein the one or more of additional sensors positioned on the sensor line are one or more of ammonia sensor, pH sensor, and carbon dioxide sensor.

28. The sensing and storage system of claim 1, further comprises a blood pressure monitor to monitor a blood pressure of a patient, wherein a pump rate of the control pump is automatically adjusted by the control system communicating with the blood pressure monitor based on the blood pressure.

29. The sensing and storage system of claim 28, wherein the control system reduces the pump rate of the control pump if the blood pressure detected by the blood pressure monitor is below a predetermined range.

30. The sensing and storage system of claim 28, wherein the control system increases the pump rate of the control pump if the blood pressure detected by the blood pressure monitor does not show a predetermined significant drop.

31. The sensing and storage system of claim 1, further comprising one or more chemical sensors to detect one or more chemical concentrations in the dialysate.

32. The sensing and storage system of claim 31, wherein the control system adds fluid to the dialysate flow loop from one or more of a sodium chloride reservoir, a sodium bicarbonate reservoir, a fluid reservoir and a water reservoir, if one or more of the chemical concentrations in the dialysate are outside of proper ranges, the chemical concentrations detected by the one or more chemical sensors in the sensor line.