SENSING AND STORAGE SYSTEM FOR FLUID BALANCE

• US 20160166748A1
• Filed: 12/10/2014
• Published: 06/16/2016
• 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.
• Granted Patent: US 10,098,993 B2
• Time in Patent Office: Days
• US Class Current: 1/1
• 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; and

wherein the outflow sensor and the inflow sensor are in electronic communication with the control pump.

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 the pump rate of the control pump is automatically adjusted to remove a prescribed amount of fluid based on the 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 the flow rate of dialysate at the inflow sensor and the 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 fluid bi-directionally.

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 1, wherein one or more additional flow sensors are provided between any fluid pump and a dialyzer inlet.

13. The sensing and storage system of claim 2, further comprising one or more additional flow sensor 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, wherein the dialysate flow loop has a controlled volume;

determining the rate of fluid flow in the dialysate flow 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 a control pump based on the deviation wherein the control pump is capable of moving fluid from a dialysate flow loop into a 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 further comprising a control system, 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 an extracorporeal flow path, wherein transferring the volume of fluid to the extracorporeal flow path results in blood in the extracorporeal flow path 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 an inflow sensor, and the rate of fluid flow in the dialysate flow loop on the outlet side of the dialyzer is determined with an 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 an inflow sensor, determining the rate of flow in the dialysate flow loop on the outlet side of the dialyzer with an 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 difference between the rate of flow is within a predetermined limit.