Fluid control system and disposable assembly

• US 10,010,686 B2
• Filed: 01/29/2014
• Issued: 07/03/2018
• Est. Priority Date: 02/27/2006
• Status: Active Grant

• Current Assignee: Fresenius KABI USA LLC (Fresenius SE & Co. KGaA)
• Original Assignee: Ivenix, Inc. (Fresenius SE & Co. KGaA)
• Inventors: Ambrosina, Jesse E., Powers, Benjamin G.
• Primary Examiner(s): Medway, Scott
• Application Number:
  US14/167,067
• Publication Number:
  US 20140148757A1
• Time in Patent Office: 1,616 Days
• CPC Class Codes: A61M 5/1415 Stands, brackets or the like for supporting infusion accessories
• CPC Class Codes: A61M 5/14224 Diaphragm type
• CPC Class Codes: A61M 5/14593 the diaphragm being actuated by fluid pressure
• CPC Class Codes: A61M 5/16809 by repeated filling and emptying of an intermediate volume pressure infusion using positive displacement pumps A61M5/142
• CPC Class Codes: A61M 5/16813 by controlling the degree of opening of the flow line
• CPC Class Codes: A61M 5/16827 controlling delivery of multiple fluids, e.g. sequencing, mixing or via separate flow-paths infusion of multiple fluids without using a controller A61M5/1407
• CPC Class Codes: A61M 5/38 using hydrophilic or hydrophobic filters

Abstract

A system for controlled delivery of medicinal fluid includes a fluid pathway assembly defining a fluid pathway and including means for calculating a first calculated fluid flow rate using gas laws. The fluid pathway assembly has an inline flow sensor element received within the fluid pathway movable in response to fluid flowing in the fluid pathway. A flow control device is removably attached to the fluid pathway assembly and has a sensor for sensing a position of the inline flow sensor element in the fluid pathway, the position of the inline flow sensor element being representative of a second calculated fluid flow rate. The fluid pathway assembly includes a variable flow resistor adjustable to regulate a rate of fluid flow in the fluid pathway assembly. A drive mechanism attached to the flow control device is operably coupled to the variable flow resistor when the flow control device is attached to the fluid pathway assembly. The variable flow resistor is adjustable by the drive mechanism to achieve a target flow rate when the first calculated flow rate and/or the second calculated flow rate differs from the target flow rate.

Claims

1. A fluid delivery system comprising:

a fluid delivery assembly including an inlet, an outlet, a pneumatic pump, a fluid flow resistor, and a fluid pathway, the fluid pathway extending between the inlet and the outlet, the fluid flow resistor disposed in the fluid pathway, the pneumatic pump being a diaphragm pump;

a pressure sensor to monitor a pressure of gas applied to a pumping chamber of the pneumatic pump, application of the pressure causing the diaphragm pump to pump fluid through the fluid pathway from the inlet to the outlet;

a controller to control a flow rate of the fluid through the fluid pathway, the controller operable to control the pressure of the gas and control a setting of the fluid flow resistor, the controller operable to adjust the setting of the fluid flow resistor to deliver the fluid through the fluid pathway out of the outlet to a recipient, the fluid flow resistor incrementally adjustable by the controller in a range between a full open setting and a full closed setting to control the flow rate as indicated by a received flow rate setting, incremental adjustment of the setting of the fluid flow resistor by the controller operable to produce a corresponding incremental adjustment to the flow rate;

the controller further operable to determine changes to the pressure of the gas and apply the changes to the pressure of the gas to control the flow rate of the fluid through the fluid pathway;

wherein the flow rate of the fluid through the fluid pathway is calculated by;

measuring the pressure of the gas applied to the pumping chamber of the diaphragm pump, measuring pressure of gas in a chamber of known volume, and then calculating a respective volume of the pumping chamber of the diaphragm pump over time based on the pressure of the gas applied to the pumping chamber and the known volume; and

wherein the changes to the pressure represent an adjustment applied to the setting of the pressure of the gas in order to match the flow rate of the fluid through the fluid pathway to the received flow rate setting.

2. The fluid delivery system as in claim 1, wherein the controller operates the pneumatic pump to provide a continuous flow of the fluid in a flow range between one tenth of a milliliter per hour and one thousand milliliters per hour.

3. The fluid delivery system as in claim 1, wherein the fluid delivery assembly is a disposable cassette inserted into a cavity of the controller.

4. The fluid delivery system as in claim 1, wherein the fluid delivery assembly is a detachable and disposable with respect to the controller.

5. The fluid delivery system as in claim 1, wherein the fluid delivery assembly is disposable with respect to the controller and includes a bubble detector integrated into a cavity of the controller.

6. The fluid delivery system as in claim 5, wherein insertion of the fluid delivery assembly into the cavity aligns a portion of the fluid pathway in the cassette to be adjacent to the bubble detector.

7. The fluid delivery system as in claim 5, wherein the bubble detector includes a first element spaced apart from a second element;

wherein the fluid delivery assembly includes a first opening to receive the first element; and

wherein the fluid delivery assembly includes a second opening to receive the second element.

8. The fluid delivery system as in claim 7, wherein the first element and the second element protrude from a surface of the controller;

and

wherein a portion of the fluid pathway resides between the first element and the second element.

9. The fluid delivery system as in claim 5, wherein insertion of the fluid delivery assembly in the cavity aligns a portion of the fluid pathway adjacent to the bubble detector.

10. The fluid delivery system as in claim 1, wherein the controller monitors a pressure of fluid in the fluid pathway at a location in the fluid pathway between the fluid flow resistor and a bubble detector in the fluid delivery assembly.

11. The fluid delivery system as in claim 1, wherein the controller dynamically controls the setting of the fluid flow resistor to control the flow rate of the fluid through the fluid pathway.

12. The fluid delivery system as in claim 1, wherein the controller periodically calculates, based on a pressure of the gas as detected by the pressure sensor, a volume of fluid entering and leaving a chamber of the pneumatic pump over time to dynamically control the flow rate of the fluid through the fluid pathway.

13. The fluid delivery system as in claim 1, wherein the controller controls the pressure of the gas inputted to a chamber of the pneumatic pump to compensate for changes in a height of a source providing the fluid to the inlet.

14. The fluid delivery system as in claim 13, wherein the controller controls the pressure of the gas inputted to a chamber of the pneumatic pump to compensate for changes in fluid back pressure present on the outlet.

15. The fluid delivery system as in claim 4, wherein the controller operates the pneumatic pump to provide a continuous flow of fluid in a flow range between 0.1 milliliter per hour and one thousand milliliters per hour.

16. The system as in claim 1, wherein the pneumatic pump includes a chamber to receive the gas;

and

wherein the controller determines the flow rate of the fluid out the outlet based on measuring an initial volume of the gas in the chamber of the pneumatic pump and then monitoring pressure decay of the volume of the gas in the chamber of the pneumatic pump over time.

17. The fluid delivery system as in claim 1, wherein the received flow rate setting is a non-zero flow rate setting of continuous fluid flow through the fluid flow resistor;

and

wherein the controller, in addition to being operable to adjust the setting of the fluid flow resistor, is operable to control a magnitude of the pressure of the gas applied to operate the pneumatic pump to control the flow rate in accordance with the received flow rate setting.

18. The fluid delivery system as in claim 17, wherein the controller is operable to repeatedly adjust an orifice setting of the fluid flow resistor to fall between the full open setting and the full closed setting to deliver the fluid at a flow rate as indicated by the received flow rate setting.

19. The fluid delivery system as in claim 1, wherein the received flow rate setting indicates a respective flow rate that falls in a range between a non-zero minimum flow rate setting and a non-zero maximum flow rate setting.

20. The fluid delivery system as in claim 19, wherein the controller is operable to sense a flow rate of the fluid through the pathway;

and

wherein the controller is operable to vary adjustment of the setting of the fluid flow resistor to be between the full open setting and the full closed setting in order to match the sensed flow rate of the fluid through the pathway to the received flow rate setting.

21. The fluid delivery system as in claim 20, wherein the controller is operable to control a pressure of the pneumatic pump and controls the setting of the fluid flow resistor to provide a continuous flow of the fluid to a recipient through the fluid pathway at the received flow rate setting.

22. The fluid delivery system as in claim 1, wherein the controller is operable to adjust the setting of the fluid flow resistor to be at an intermediate position in a range between the full open setting and the full closed setting to continuously deliver the fluid to the recipient as indicated by the received flow rate setting.

23. The fluid delivery system as in claim 22, wherein the controller is operable to vary the setting of the fluid flow resistor at intermediate positions in the range to selectively increase or decrease the flow rate of continuously delivering the fluid to the recipient.

24. The fluid delivery system as in claim 1, wherein the pressure sensor is a first pressure sensor, the fluid delivery system further comprising:

a second pressure sensor to detect a respective pressure of fluid in the fluid pathway between the fluid flow resistor and the outlet.

25. The fluid delivery system as in claim 1, wherein the fluid delivery system includes a cavity in which to receive the fluid delivery assembly.

26. The fluid delivery system as in claim 1, wherein the fluid delivery system includes a cavity in which to receive the fluid delivery assembly, the fluid delivery system further comprising:

a pneumatic interface disposed in the cavity, the pneumatic interface operable to guide and sealably couple a port on the fluid delivery assembly to the pneumatic interface when the fluid delivery assembly is inserted into the cavity, the pneumatic interface further operable to control the pneumatic pump and delivery of the fluid through the fluid pathway from the inlet to the outlet.

27. The fluid delivery system as in claim 26 further comprising:

a fluid resistor driver interface disposed in the cavity, the fluid resistor driver interface controlled by the controller to control the setting of the fluid flow resistor to multiple different positions in the range between the full open setting and the full closed setting of the fluid flow resistor to control the flow rate of the fluid through the fluid pathway.

28. The fluid delivery system as in claim 27, wherein the pneumatic pump includes a first chamber and a second chamber separated by a flexible membrane, the first chamber filled with a portion of the fluid passing through the fluid pathway, the second chamber filled with a portion of the gas;

and

wherein the pressure sensor is disposed in the fluid delivery system external to the fluid delivery assembly.

29. The fluid delivery system as in claim 26, wherein the port of the fluid delivery assembly includes a protrusion;

and

wherein the pneumatic interface includes an opening in the cavity to receive the protrusion.

30. The fluid delivery system as in claim 1, wherein the fluid delivery assembly includes multiple valves disposed in the pathway in addition to the fluid flow resistor, the fluid delivery system further comprising:

a control interface operable to control settings of the multiple valves and delivery of the fluid through the fluid pathway.

31. The fluid delivery system as in claim 1 further comprising:

a driver resource in communication with the fluid flow resistor, the driver resource operable to control a degree to which the fluid flow resistor resists the flow of the fluid through the fluid pathway.

32. The fluid delivery system as in claim 24, wherein the fluid delivery assembly is a disposable cassette removably inserted into a cavity of the fluid delivery system, the second pressure sensor disposed in the disposable cassette.

33. The fluid delivery system as in claim 1, wherein the controller is operable to calculate a flow rate of the fluid through the pathway;

and

wherein the controller is operable to modify the setting of the fluid flow resistor to a new setting between the full open setting and the full closed setting in order to control the flow rate of the fluid through the pathway to a desired flow rate setting inputted to the fluid delivery system.

34. The fluid delivery system as in claim 1, wherein application of the changes to the pressure of the gas is operable to control the flow rate of the fluid through the fluid pathway to the received flow rate setting.

35. The fluid delivery system as in claim 1, further comprising:

a flow control valve, the flow control valve disposed in the fluid pathway between the pneumatic pump and the fluid flow resistor, the controller operable to control a setting of the flow control valve to selectively control the flow of the fluid through the fluid flow resistor to a target recipient.

36. The fluid delivery system as in claim 35, wherein the fluid flow resistor is controlled independently with respect to the flow control valve.

37. The fluid delivery system as in claim 1 further comprising:

a flow control valve, the flow control valve disposed in the fluid pathway between the pneumatic pump and the fluid flow resistor, the controller operable to control a setting of the flow control valve to selectively prevent the flow of the fluid through the fluid flow resistor to a target recipient.

38. The fluid delivery system as in claim 37, wherein the controller is further operable to control the setting of the flow resistor independently of controlling the setting of the flow control valve.

39. The fluid delivery system as in claim 1, wherein the controller is operable to control a timing of applying changes to the pressure of the gas to control the flow rate of the fluid through the fluid pathway as indicated by the received flow rate setting.

40. The fluid delivery system as in claim 1 further comprising:

an air elimination filter disposed in the fluid pathway, the air elimination filter operable to remove air from the fluid passing through the fluid pathway; and

wherein the fluid flows in a downstream direction through the fluid pathway from the inlet port to the outlet port, the air elimination filter disposed downstream in the fluid pathway with respect to the pneumatic pump, the fluid flow resistor disposed downstream in the fluid pathway with respect to the air elimination filter.

41. The fluid delivery system as in claim 1, wherein the controller is further operable to:

determine changes to the setting of the fluid flow resistor needed to match the flow rate of the fluid through the fluid pathway to the flow rate setting; and

apply a combination of the changes to the pressure of the gas and the changes to the setting of the fluid flow resistor to match the flow rate of the fluid through the fluid pathway to the received flow rate setting.

42. The fluid delivery system as in claim 1, wherein the changes represent an adjustment needed to be applied to the setting of the pressure of the gas in order to subsequently match the flow rate of the fluid through the fluid pathway to the received flow rate setting.

43. The fluid delivery system as in claim 42, wherein the flow rate of the fluid through the fluid pathway is measured by periodically calculating the respective volume of the pumping chamber of the diaphragm pump over time.

44. The fluid delivery system as in claim 43, wherein the controller is operable to determine the respective volume based at least in part on the pressure of the gas applied to operate the pneumatic pump.

45. The fluid delivery system as in claim 44, wherein application of the changes to the pressure of the gas causes the flow rate of the fluid to match the received flow rate setting.

46. The fluid delivery system as in claim 45, wherein the pressure sensor is a first pressure sensor, the fluid delivery system further comprising:

a second pressure sensor to detect a respective pressure of fluid in the fluid pathway between the fluid flow resistor and the outlet.

47. The fluid delivery system as in claim 46, wherein the controller is further operable to:

determine changes to the setting of the fluid flow resistor needed to match the flow rate of the fluid through the fluid pathway to the flow rate setting; and

apply a combination of the changes to the pressure of the gas and the changes to the setting of the fluid flow resistor to match the flow rate of the fluid through the fluid pathway to the flow rate setting.

48. The fluid delivery system as in claim 1, wherein gas in the chamber of known volume is selectively isolated from the gas in the pumping chamber of the diaphragm pump via a valve.