Biological fluid flow control apparatus and method

• US 10,220,132 B2
• Filed: 12/19/2014
• Issued: 03/05/2019
• Est. Priority Date: 12/19/2014
• Status: Active Grant

• Current Assignee: Fenwal Incorporated (Fresenius SE & Co. KGaA)
• Original Assignee: Fenwal Incorporated (Fresenius SE & Co. KGaA)
• Inventors: Patel, Amit J., Planas, Samantha M., Higginson, Kathleen M., Thill, Melissa A., Moore, Courtney
• Primary Examiner(s): Lo, Kenneth M
• Assistant Examiner(s): Wynne, David J
• Application Number:
  US14/577,322
• Publication Number:
  US 20160175510A1
• Time in Patent Office: 1,537 Days
• CPC Class Codes: A61M 1/341 by measuring the filtrate rate or volume
• CPC Class Codes: A61M 1/3496 Plasmapheresis; Leucopheresis; Lymphopheresis A61M1/3472 takes precedence
• CPC Class Codes: A61M 1/3607 Regulation parameters
• CPC Class Codes: A61M 1/3621 Extra-corporeal blood circuits single-needle circuits A61M1/30
• CPC Class Codes: A61M 1/3639 Blood pressure control, pressure transducers specially adapted therefor
• CPC Class Codes: A61M 2005/16863 Occlusion detection
• CPC Class Codes: A61M 2005/16868 Downstream occlusion sensors
• CPC Class Codes: A61M 2205/18 with alarm
• CPC Class Codes: A61M 2205/3331 Pressure; Flow
• CPC Class Codes: A61M 2205/3334 Measuring or controlling the flow rate
• CPC Class Codes: A61M 2205/3337 Controlling, regulating pressure or flow by means of a valve by-passing a pump
• CPC Class Codes: A61M 2205/3341 stabilising pressure or flow to avoid excessive variation
• CPC Class Codes: A61M 2205/50 with microprocessors or computers
• CPC Class Codes: A61M 5/14212 Pumping with an aspiration and an expulsion action
• CPC Class Codes: A61M 5/16831 Monitoring, detecting, signalling or eliminating infusion flow anomalies low-level float-valves causing cut-off A61M5/40; indicating or recording presence, absence or direction of flow in general G01P13/0066
• CPC Class Codes: A61M 5/16854 by monitoring line pressure
• CPC Class Codes: G01F 7/005 by measuring pressure or differential pressure, created by the use of flow constriction
• CPC Class Codes: G05D 16/2066 using controlling means acting on the pressure source
• CPC Class Codes: G05D 7/0676 by action on flow sources G05D7/0688, G05D7/0694 take precedence

Abstract

Apparatus, system and method are provided for controlling flow through a biological fluid processing device. Pressure of fluid flow through a flow path is monitored and flow rate in the flow path is increased or decreased based on sensed pressure levels for selected periods of time. This has particular application in controlling flow in an infusion or return flow path of an apheresis device that separates whole blood into one or more blood components.

Claims

1. A method for controlling flow through a biological fluid processing device fluid flow path into a living subject, comprising:

flowing fluid through the fluid flow path at a flow rate;

repeatedly monitoring the pressure of fluid flowing in the fluid flow path relative to at least a low pressure level, an upper pressure level above the low pressure level and a maximum pressure level above the upper pressure level, the repeated monitoring being at a selected time interval between each monitoring cycle;

decreasing the fluid flow rate in the fluid flow path by a selected amount of decrease if the monitored pressure is continuously between the upper pressure level and the maximum pressure level for a certain amount of time greater than the selected time interval;

incrementally advancing a flow rate increase clock at each monitoring cycle if the monitored pressure is below the low pressure level and the fluid flow rate is at a desired rate;

increasing the flow rate of fluid in the fluid flow path by a selected amount of increase if the flow rate increase clock indicates that the monitored pressure has been continuously below the low pressure level for at least another amount of time greater than the selected time interval and, if so, restarting the flow rate increase clock;

restarting the flow rate increase clock if the monitored pressure is above the low pressure level, and

leaving the fluid flow rate unchanged if the monitored pressure is between the low pressure level and the upper pressure level.

2. The method of claim 1 wherein the flow rate of fluid in the fluid flow path is not increased if the monitored pressure is above the maximum pressure level or decreased if the flow rate is below a minimum fluid flow rate.

3. The method of claim 1 including repeating the monitoring, increasing, decreasing and leaving steps until a selected amount of fluid is flowed through the fluid flow path.

4. The method of claim 1 in which the selected amount of increase is less than the selected amount of decrease.

5. The method of claim 1 in which the certain amount of time is less than the other amount of time.

6. The method of claim 2 in which the maximum, low and upper pressure levels are based at least in part on the viscosity of the fluid flowing in the fluid flow path.

7. The method of claim 1 in which the fluid flow rate does not exceed the lesser of an operator-selected flow rate and a citrate tolerance flow rate.

8. The method of claim 1 in which at least one of the low pressure level, upper pressure level, the selected amount of decrease, the selected amount of increase, the other amount of time and certain amount of time is varied while flowing fluid through the fluid flow path.

9. The method of claim 8 including incrementally advancing a flow rate decrease clock at each monitoring cycle if the monitored pressure is between the upper pressure level and the maximum pressure level;

decreasing the fluid flow rate by the selected amount of flow rate decrease if the flow rate decrease clock indicates that the certain time period has passed and, if so, restarting the flow rate decrease clock; and

restarting the flow rate decrease clock if the monitored pressure is below the upper pressure level.

10. A durable biological fluid processing device for processing biological fluid in a disposable fluid processing flow circuit of the type including a fluid flow path for directing fluid flow from the processing circuit to a living subject, the device including a pump for pumping fluid through the fluid flow path, a pressure sensor for monitoring fluid pressure in the flow path and a controller cooperatively associated with the pump and the pressure sensor for controlling the flow rate and pressure of fluid flowing through the fluid flow path, wherein the controller is configured to, at least:

repeatedly monitor the pressure of fluid flowing in the fluid flow path relative to at least a low pressure level, an upper pressure level above the low pressure level and a maximum pressure level above the upper pressure level, the repeated monitoring being at a selected time interval between each monitoring cycle;

decrease the fluid flow rate in the fluid flow path by a selected amount of decrease if the monitored pressure is continuously between the upper pressure level and the maximum pressure level for a certain amount of time greater than the selected time interval; and

leave the fluid flow rate unchanged if the monitored pressure is between the low pressure level and the upper pressure level;

the controller including a flow rate increase clock operable to determine if another time period greater than the selected time interval has passed, the controller being further configured to (i) incrementally advance the flow rate increase clock at each monitoring cycle if the monitored pressure is below the low pressure level and the flow rate is at a desired rate, (ii) increase the fluid flow rate by a selected amount of flow rate increase if the flow rate increase clock indicates that the monitored pressure has been continuously below the low pressure low pressure level for at least the other time period and, if so, restart the flow rate increase clock, and (iii) restart the flow rate increase clock if the monitored pressure is above the low pressure level.

11. A durable biological fluid processing device in accordance with claim 10 wherein the controller is configured so that the flow rate of fluid in the fluid flow path is not increased if the monitored pressure is above the maximum pressure level or decreased if the flow rate is below a minimum fluid flow rate.

12. A durable biological fluid processing device in accordance with claim 10 wherein the controller is configured so that the selected amount of flow rate increase is less than the selected amount of flow rate decrease.

13. A durable biological fluid processing device in accordance with claim 10 wherein the controller is configured so that the certain amount of time is less than the other amount of time.

14. A durable biological fluid processing device in accordance with claim 10 wherein the controller is configured so that the maximum, low and upper pressure levels are based at least in part on the viscosity of the fluid flowing in the fluid flow path.

15. A durable biological fluid processing device in accordance with claim 10 wherein the controller is configured so that at least one of the low pressure level, the upper pressure level, the selected amount of flow rate decrease, the selected amount of flow rate increase, the certain amount of time and/or the other amount of time is changeable while flowing fluid through the fluid flow path.

16. A durable biological fluid processing device in accordance with claim 10 wherein the controller is configured so that the monitoring, increasing, decreasing and leaving steps are repeated until a selected amount of fluid is flowed through the fluid flow path.

17. A durable biological fluid processing device in accordance with claim 10 further comprising a disposable fluid processing flow control circuit.

18. A durable biological fluid processing device in accordance with claim 10 in which the controller is configured to incrementally advance a flow rate decrease clock at each monitoring cycle if the monitored pressure is between the upper pressure level and the maximum pressure level;

decrease the fluid flow rate by the selected amount of flow rate decrease if the flow rate decrease clock indicates that the certain time period has passed and, if so, restart the flow rate decrease clock; and

restart the flow rate decrease clock if the monitored pressure is below the upper pressure level.