AUTOMATED FLUID FLOW CONTROL SYSTEM

• US 20110028937A1
• Filed: 10/16/2010
• Published: 02/03/2011
• Est. Priority Date: 02/27/2006
• Status: Abandoned Application

• Current Assignee: Ivenix, Inc. (Fresenius SE & Co. KGaA)
• Original Assignee: Fluidnet Corporation (Fresenius SE & Co. KGaA)
• Inventors: Powers, Benjamin G., Carlisle, Jeffrey A., Kuba, Lawrence M.
• Application Number:
  US12/906,077
• Publication Number:
  US 20110028937A1
• Time in Patent Office: Days
• US Class Current: 604/500
• 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

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 system for the controlled delivery of medicinal fluid, the system comprising:

a flow control device including a processor, a source of pressurized gas, a first pressure sensor, position sensor, and a motor;

a fluid pathway assembly having an inlet, an outlet, a fluid pathway extending between said inlet and said outlet, and a variable flow resistor;

a pneumatic pumping chamber in said fluid pathway assembly, said pnuematic pumping chamber including a gas receiving volume, a fluid receiving volume, and a flexible membrane separating said gas receiving volume and said fluid receiving volume;

said source of pressurized gas fluidically coupled to said gas receiving volume for selectively increasing or decreasing a gas pressure within said gas receiving volume, wherein flow rate of the medicinal fluid during operation is responsive to pressure changes in said gas receiving volume;

said first pressure sensor fluidically coupled to said gas receiving volume for sensing a pressure in said gas receiving volume;

an inline flow sensor element received within said fluid pathway, said inline flow sensor element movable in response to a fluid flowing in said fluid pathway;

said position sensor for sensing a position of said inline flow sensor element in said fluid pathway, the position of said inline flow sensor element in said fluid pathway correlated to a rate of fluid flowing in said fluid pathway;

said motor coupled to said variable flow resistor to adjust said variable flow resistor wherein the rate of fluid flowing in said fluid pathway is responsive to adjustments to said variable flow resistor;

said processor for calculating a first calculated flow rate using pressure information from said first pressure sensor;

said processor for selectively adjusting one or both of the pressure within said gas receiving volume and said variable flow resistor during operation to achieve a target flow rate.

2. The system of claim 1, further comprising:

said processor for calculating a second calculated flow rate using a sensed position of said inline flow sensor element in said fluid pathway.

3. The system of claim 1, wherein said variable flow resistor is manually adjustable to regulate a rate of fluid flow in the fluid pathway assembly.

4. The system of claim 1, wherein the source of pressurized gas is a pump.

5. The system of claim 1, wherein the first calculated flow rate is calculated based on a change in a volume of gas contained within said gas receiving volume over time and further wherein the volume of gas contained within said gas receiving volume is calculated using an ideal gas law.

6. The system of claim 1, wherein said position sensor is calibrated using said first calculated flow rate.

7. The system of claim 1, further comprising:

said motor adjusting said variable flow resistor in accordance with the sensed signal from said position sensor representative of the position of said inline sensor element within said fluid pathway assembly.

8. The system of claim 1, further comprising:

said inlet fluidically coupled to a fluid source and said outlet fluidically coupling to a patient.

9. The system of claim 7, further comprising a visual indicator of fluid flow selected from one or both of a human viewable display and a drip chamber.

10. The system of claim 1, further comprising:

a display on said flow control device coupled to said processor for displaying flow rate information in human-viewable form.

11. The system of claim 1, further comprising:

said inline flow sensor element including an elongated element positioned to impede flow from the inlet to the outlet, said fluid pathway assembly further including a spring received within said fluid pathway to urge said elongated element in a direction opposite flow from said inlet, said elongated element further comprising a transparent spherical element centrally positioned in said elongated element; and

said position sensor including a light source and an optical detector for generating signals in response to movement of said spherical element.

12. The system claim 11, wherein said transparent spherical element acts as a lens to condition light transmitted from the light source to the optical sensor.

13. The system of claim 1, further comprising:

said inline flow sensor element including an elongated element positioned to impede flow from the inlet to the outlet, said fluid pathway assembly further including a spring received within said fluid pathway to urge said elongated element in a direction opposite flow from said inlet, said elongated element including an optically transparent element centrally positioned in said elongated element; and

said position sensor including a light source and an optical detector for generating signals in response to movement of said optically transparent element.

14. The system of claim 13, wherein said optically transparent element acts as a lens to condition light transmitted from the light source to the optical sensor.

15. The system of claim 1, further comprising:

at least one chamber of known volume

a second pressure sensor for sensing a pressure of said chamber of known volume; and

a valve for selectively isolating and fluidically coupling said chamber of known volume and said gas receiving volume.

16. The system of claim 15, wherein the volume of said pneumatic pumping chamber is not precisely known.

17. The system of claim 1, further comprising:

an inlet check valve for drawing the medicinal fluid from said inlet into said fluid receiving volume when a negative pressure is applied to said gas receiving volume and preventing passage of the medicinal fluid from said fluid receiving volume toward said inlet when a positive pressure is applied to said gas receiving volume; and

an outlet check valve for expelling the medicinal fluid from said fluid receiving volume to said outlet when a positive pressure is applied to said gas receiving volume and preventing passage of the medicinal fluid downstream of said fluid receiving volume into said fluid receiving volume when a negative pressure is applied to said gas receiving volume.

18. The system of claim 17, where said membrane seals an outlet of said fluid receiving volume preventing fluid flow when an increased gas pressure is maintained in said gas receiving volume.

19. The system of claim 15, further comprising:

said processor for calculating a volume of gas in said gas receiving volume using an initial pressure in the gas receiving volume and an initial pressure in the chamber of known volume when the gas receiving volume and the chamber of known volume are fluidically isolated, a final pressure in the gas receiving volume and the chamber of known volume when the gas receiving volume and chamber of known volume are fluidically combined, and a known volume of gas in the chamber of known volume.

20. The system of claim 19, further comprising:

said processor using periodic measurements of said volume of gas in said gas receiving volume to calculate said first calculated flow rate.

21. The system of claim 20, further comprising:

said processor comparing said first calculated fluid flow rate with a target flow rate and controlling said source of pressurized gas to change the pressure in said gas receiving volume until the first calculated fluid flow rate is substantially equal to the target flow rate.

22. The system of claim 20, further comprising:

said processor calibrating said position sensor by associating said first calculated flow rate with a sensed position of said inline flow sensor element in said fp.

23. A method for the controlled delivery of medicinal fluid from a fluid source to a patient, said method comprising:

connecting a first fluid source containing a first fluid to be infused into a patient to a first inlet of a fluid pathway assembly having a manually adjustable variable flow resistor, the fluid pathway assembly defining a fluid pathway and having a first pneumatic pumping chamber for driving fluid though the pathway and an inline flow sensor element received within the fluid pathway, the sensor element movable in response to fluid flowing in the fluid pathway;

connecting a fluid control device which is removably attachable to the fluid pathway assembly, the fluid control device providing the pneumatic control to drive fluid through the fluid pathway and having a sensor for detecting movement of the inline flow sensor element;

calculating an actual flow rate by one or both of measuring pressure changes in the pneumatic pumping chamber as a function of time or sensed position of the inline flow sensor element; and

monitoring the actual flow rate and automatically adjusting one or both of pressure in the pneumatic pumping chamber and the variable flow resistor to achieve a first target flow rate.

24. The method of claim 23, further comprising:

connecting a second fluid source containing a second fluid to be infused into a patient to a second inlet of said fluid pathway, said fluid pathway having a second pneumatic pumping chamber for driving fluid though the pathway.

25. The method of claim 23 further comprising:

calculating a difference between the actual flow rate and the first target flow rate;

if the difference between the actual flow rate and the first target flow rate is greater than a preselected threshold value, periodically varying a pressure in the pneumatic pumping chamber and measuring the actual flow rate until the difference between the actual flow rate and the first target flow rate is less than the preselected threshold value; and

if the difference between the actual flow rate and the first target flow rate is less than a preselected threshold value, periodically varying the pressure in the pneumatic pumping chamber and measuring the actual flow rate until the actual flow rate is equal to the first target flow rate.

26. The method of claim 25, further comprising:

providing the fluid pathway with at least one chamber of known volume, said chamber including check valve means to allow fluid in said fluid pathway to flow only from said inlet towards said outlet, said chamber divided with a flexible membrane moveable within said chamber and in fluidic contact with said first fluid to be infused to be delivered, said chamber including a port to pneumatically couple said control device to said chamber of said fluid pathway;

further providing means for varying gas pressure on said membrane through said port, said varying gas pressure causing said membrane to move within said chamber, expelling said first fluid to be infused from said chamber towards said outlet when the pressure is increased or drawing said first fluid to be infused from said inlet when the pressure is decreased; and

monitoring the actual flow rate and automatically adjusting the either or both of the pneumatic profile on the membrane and the variable flow resistor to achieve a first target flow rate.

27. The method of claim 25, further comprising:

monitoring a signal provided by the flow sensor and triggering an alarm if the signal indicates the passage of air.

28. The method of claim 23, further comprising:

monitoring the actual flow rate and triggering an alarm if the actual flow rate is unable to match the first target flow rate.

29. The method of claim 23, further comprising:

communicating infusion status information to a computer based information handling system via a wireless communication link.

30. The method of claim 29, further comprising:

automatically detecting device location and communicating location information to the computer based information handling system.

31. The method of claim 30, further comprising:

determining if the location of the device is associated with a patient identifier;

if the location of the device is associated with a patient identifier, associating the device with the patient identifier.

32. The method of claim 30, where the wireless communication link is accomplished through a mesh network.

33. The method of claim 29, further comprising:

automatically detecting caregiver identification and communicating caregiver identification to the computer based information handling system.

34. A system for the controlled delivery of medicinal fluid, the system comprising:

a first medicinal fluid to be delivered;

a fluid pathway assembly defining a fluid pathway and having an inline flow sensor element received within said fluid pathway, said inline flow sensor element movable in response to a fluid flowing in said fluid pathway;

a flow control device removably attached to said fluid pathway assembly and having a position sensor for detecting movement of said inline flow sensor element;

said fluid pathway assembly having a variable flow resistor which is manually adjustable to regulate a rate of fluid flow in the fluid pathway assembly;

said fluid pathway including a first chamber including a first chamber volume and a second chamber volume separated by a first flexible member intermediate the first chamber volume and the second chamber, the first chamber volume being filled with said first medicinal fluid to be delivered and the second volume filled with gas and including a port;

check valves for controlling flow into and out of said first chamber;

said flow control device including means for pneumatically coupling a chamber of known volume to said port in said second chamber volume, said flow control device further including means to selectively increase or decrease the pressure in said second chamber volume, said increase or decrease in pressure acting to move said first flexible member in said chamber to selectively expel the first medicinal fluid from the first chamber volume or draw the first medicinal fluid into said first chamber volume;

a motor attached to the flow control device, said motor operably coupled to said variable flow resistor when said flow control device is attached to said fluid pathway assembly; and

said variable flow resistor adjustable by said motor under automatic control to adjust a rate of flow of said first medicinal fluid in said fluid pathway.

35. The system of claim 34, further comprising:

means to measure a pressure of said gas in said second chamber volume;

means to determine a volume of the medicinal fluid present in said first chamber volume based on said pressure of said gas in said second volume; and

means for periodically calculating the volume of the medicinal fluid in said first chamber volume over time to determine a measured flow rate.

36. The system of claim 35, further comprising:

means for modifying the pressure in said second chamber volume until the measured flow rate matches a preselected target flow rate.

37. The system of claim 34, further comprising:

said position sensor for detecting movement of said inline flow sensor element including a light source and an optical detector;

said inline flow sensor element received within said fluid pathway including a flow element positioned in a tapered portion of the flow path;

said inline flow sensor element further including a spring to urge said flow element to oppose flow from said inlet; and

said light source and said optical detector positioned around said flow element to detect a position of the flow element when the force of fluid flow causes said flow element to move towards said outlet, compressing said spring.

38. The system of claim 37, wherein said flow element includes a spherical element to focus said light to improve resolution on said detector.

39. The system of claim 35, further comprising means to wirelessly communicate infusion status information to a computer based information handling system.

40. The system of claim 39, wherein the computer based information handling system is a network.

41. The system of claim 40, wherein said network is a mesh network.

42. The system of claim 41, wherein said flow control device include means to automatically detect a location of the system.

43. The system of claim 34, further comprising:

means for determining when said position sensor for detecting movement of said inline flow sensor element indicates the passage of air; and

means for generating an alarm when said air passage is detected.

44. The system of claim 35, wherein said measured flow rate is used to calibrate the output of said position sensor for detecting movement of said inline flow sensor element.

45. The system of claim 34, further comprising:

a second medicinal fluid to be delivered, said fluid pathway including a second inlet;

said second medicinal fluid being fluidically connected to said second inlet;

said second inlet including a pathway to a second chamber including a third chamber volume and a fourth chamber volume separated by a second flexible membrane, said third chamber volume being filled with said second medicinal fluid to be delivered and said fourth chamber volume filled with gas and including a second port;

check valves for controlling flow into and out of said second chamber;

said flow control device including means for pneumatically coupling the chamber of known volume to said second port in said second chamber, said device further including a means to selectively increase or decrease the pressure in said fourth chamber volume, said increase or decrease in pressure acting to move said flexible member in said second chamber to selectively expel the second medicinal fluid out of or draw the second medicinal fluid into said third chamber volume; and

means to preferentially modify pressure in either said second chamber volume or said fourth chamber volume to selectively deliver said first or said second medicinal fluid to be delivered.

46. The system of claim 44, further comprising a program of instructions for:

sensing an abrupt flow increase from the flow sensor;

measuring a duration of the abrupt flow increase;

integrating the sensed abrupt flow increase; and

creating an electronic record of a possible upstream manual bolus.

47. The system of claim 46, further comprising:

a user interface for generating output prompting a caregiver to confirm and identify the possible upstream manual bolus.

48. The system of claim 47, further comprising:

said user interface for receiving input from the caregiver for updating the electronic record based on said input.