Sensing and storage system for fluid balance

• US 10,195,327 B2
• Filed: 09/12/2017
• Issued: 02/05/2019
• 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:
  US15/701,641
• Publication Number:
  US 20180001011A1
• Time in Patent Office: 511 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 configured to receive data from the inflow sensor and the outflow sensor;

wherein said control system is configured to electronically communicate with the control pump, wherein the control system is configured to utilize a fluid balancing system configured to automatically adjust a pump rate of the control pump based on a difference between the flow measured at inflow sensor and outflow sensor to maintain a controlled volume in the dialysate flow loop.

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

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 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.

5. The sensing and storage system of claim 3, wherein the control system is in electronic communication with the at least one fluid pump other than the control pump.

6. The sensing and storage system of claim 1, wherein the control system is configured to maintain a controlled volume in the dialysate flow loop based on a fluid removal prescription for a patient.

7. 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.

8. 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.

9. The sensing and storage system of claim 1, wherein the control system is configured to periodically self-test by adjusting a pump rate of one or more pumps to make an ultrafiltration flow rate equal to zero and comparing a first reading at an inflow sensor to a second reading at an outflow sensor, wherein if said first reading and second reading are identical within a predetermined error limit, then the control system is operating properly.

10. The sensing and storage system of claim 1, wherein the control system is configured to determine a deviation of a fluid removal prescription from a difference in a flow rate measured by the inflow sensor and a flow rate measured by the outflow sensor.

11. The sensing and storage system of claim 10, wherein the control system is configured to automatically adjust the pump rate of the control pump to lower the deviation of the fluid removal prescription from the difference in the flow rate measured by the inflow sensor and the flow rate measured by the outflow sensor.

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

13. The sensing and storage system of claim 12, wherein the control system is configured to stop dialysis in response to the first flow rate being not identical to the second flow rate within a predetermined error limit.

14. The sensing and storage system of claim 1, wherein the control system is configured to obtain the controlled volume in the dialysate flow loop from a fluid removal prescription for a patient.

15. The sensing and storage system of claim 1, wherein the control system is in electronic communication with a water pump;

and wherein the control system is configured to automatically adjust a pump rate of the water pump based on the difference between the flow measured at inflow sensor and outflow sensor to maintain the controlled volume in the dialysate flow loop.

16. The sensing and storage system of claim 1, wherein the control system is configured to deliver a fluid bolus to a patient by increasing a pump rate of a water pump.

17. The sensing and storage system of claim 1, the control system in electronic communication with a sensor measuring patient blood pressure;

the control system configured to adjust the pump rate of the control pump in response to changes in patient blood pressure.

18. The sensing and storage system of claim 1, wherein the dialysate flow loop comprises a sorbent cartridge.

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

20. The sensing and storage system of claim 19, further comprising a control reservoir fluidly connected to the fluid removal line.

21. 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.