AU2003200025B2 - A fluid management system - Google Patents

Description

AUSTRALIA

Patents Act 1990 COMPLETE SPECIFICATION STANDARD PATENT Applicant: DEKA PRODUCTS LIMITED PARTNERSHIP Invention Title: A FLUID MANAGEMENT SYSTEM The following statement is a full description of this invention, including the best method of performing it known to me/us: 2 A FLUID MANAGEMENT SYSTEM The present application is a divisional application of Australian application 48358/99, the disclosure of which is incorporated herein by reference.

The present application relates to subject matter disclosed but not claimed in that application. Most of the description of application 48358/99 is incorporated herein to facilitate understanding of the present invention.

TECHNICAL FIELD The present invention relates to a fluid management system and a method for determining a first fluid's flow rate.

BACKGROUND ART In fluid management systems, a problem is the inability to rapidly detect an occlusion in a fluid line.

If a patient is attached to a fluid dispensing machine, the fluid line may become bent or flattened and therefore occluded. This poses a problem since the patient may require a prescribed amount of fluid over a given amount of time and an occlusion, if not rapidly detected, can cause the rate of transport to be less than the necessary rate. One solution in the art, for determining if a line has become occluded, is volumetric measurement of the transported fluid. In some dialysis machines, volumetric measurements occur at predesignated times to check if the patient has received the requisite amount of fluid. In this system both the fill and delivery strokes of a pump are timed. This measurement system provides far from instantaneous feedback. If the volumetric measurement is different from the expected volume over the first time period, the system may cycle and remeasure the volume of H,\janel\Keep\Speci\P47769.doc 03/01/03 -C 3-

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fluid sent. In that case, at least one additional period Smust transpire before a determination can be made as to whether the line was actually occluded. Only after at 00 least two timing cycles can an alarm go off declaring a line to be occluded.

C1 SUMMARY OF THE INVENTION C- The invention provides a fluid management system for dispensing an amount of a first fluid and monitoring a Sstate of flow of the first fluid, the system comprising: c-i a chamber having an inlet and an outlet and a septum separating the first fluid and a second fluid; a reservoir tank containing the second fluid in fluid communication with the chamber; a valve disposed between the reservoir tank and the chamber; an energy imparter for applying a time varying amount of energy on the second fluid the energy imparter comprising a membrane disposed within the chamber between the first fluid and the second fluid for pumping the first fluid in response to a pressure differential between the first fluid and the second fluid; a transducer for measuring a pressure of the second fluid within the chamber and creating a signal of the pressure; and a processor for determining whether the first fluid has stopped flowing based on the signal.

The invention provides a computer program for determining a change in a first fluid's flow rate within a line, the computer program comprising: program code for applying a time varying amount of energy to a second fluid separated from the first fluid by a membrane; program code for measuring a pressure of the second fluid in response to the applied energy; and program code for determining when flow of the H,\pau1a\keep\SPEC\P47769 AMENDED 12-O5-06.doc 8/06/06 4

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C first fluid has stopped based at least on the pressure of Sthe second fluid.

00 BRIEF DESCRIPTION OF THE DRAWINGS SThe foregoing features of the invention will be eC more readily understood by reference to the following detailed description taken with the accompanying drawings: SFig. 1 is a schematic drawing of a simplified embodiment of the invention, showing a chamber, reservoir tank and processor.

Fig. 2A shows a flow chart of a method for computing whether a fluid has stopped flowing in a line, in accordance with an embodiment of the invention.

Fig. 2B shows a graphical representation of step 202 of Fig 2A which is the pressure signal of the second fluid graphed with respect to time.

Fig. 2C shows a graphical representation of step 204 of Fig. 2A which is the derivative of step 202 graphed with respect to time.

Fig. 2D shows a graphical representation of step H;\pau1a\keep\SPECI\P47769 AEMNDED 12-O5-06.doe 8/06/06 5 c< 206 of Fig. 2A which is the magnitude of step 204 graphed with respect to time.

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4 Fig. 2E shows a graphical representation of step 208 of Fig. 2A which is step 206 low pass filtered and graphed with respect to time.

Fig. 3 shows a flow chart of a control feedback Sloop for setting the pressure within the chamber of Fig.

1, in accordance with an embodiment of the invention.

H \veronica\keep\speci\P47769A .doc 17/11/05 6 Detailed Description of Specific Embodiments Referring now to FIG. 1, a fluid management system is designated generally by numeral 10. The fluid management system is of the kind that uses the pressure of'one fluid to move another fluid. The invention will be described generally with reference to the fluid management system shown in FIG. 1, however it is to be understood that many fluid systems, such as dialysis machines and blood transport machines, may similarly benefit from various embodiments and improvements which are'subjects of the present invention.

In the following description and claims, the term "line" includes, but is not limited to, a vessel, chamber, holder, tank, conduit and, more specifically, pumping chambers for dialysis machines and blood transport machines. In the following description and claims the term "membrane" shall mean anything, such as a septum, which separates two fluids so that one fluid does not flow into the other fluid. Any instrument for converting a fluid pressure to an electrical, hydraulic, optical or digital signal will be referred to herein as a "transducer." In the following description and claims the term "energy imparter" shall refer to any device that might impart energy into a system. Some examples of energy imparters are pressurized fluid tanks, heating devices, pistons, actuators and compactors.

Overview of the System and Method of Determining if a Fluid is Flowing within a Line The system and method provides a way for quickly determining if a fluid has ceased flowing within a line. In a preferred embodiment the line is a chamber 11. The method determines if a fluid management system's pumping mechanism is at the end of its stroke and a fluid, referred to as a "first fluid", has stopped flowing. In one embodiment, the system and method are part of a fluid management system for transporting dialysis fluid 13 wherein the first fluid is moved through a chamber 11 by a pumping mechanism which may be a flexible membrane 12. The first fluid 13 may be blood, dialysis fluid, liquid medication, or any other fluid. The fluid which is on the opposite side of the membrane from the first fluid is known as the second fluid. The second fluid 14 is preferably a gas, but may be any fluid and in a preferred embodiment the air is the second fluid.

The flexible membrane 12 moves up and down within chamber 11 in response to -7 pressure changes of the second fluid. When membrane 12 reaches its lowest point it has come into contact with the bottom wall 19 of chamber 11. When membrane 12 contacts boctom wall 19 it is said to be at the bottom or end of its stroke. The end of stroke is one indication that first fluid 13 has stopped flowing. To determine if pumping mechanism 12 is at the end of its stroke, the pressure of the second fluid is continuously measured. The pressure of the second fluid is measured-for determining if the first fluid has stopped flowing.

The pressure measurement is performed within the chamber or line by a transducer Transducer 15 sends an output signal to a processor 18 which applies the remaining steps and controls the system. The signal is differentiated by processor 18, then the absolute value is taken, the signal is then low pass filtered, and finally the signal is compared to a threshold. If the signal is below the threshold, fluid has stopped flowing.

The absolute value of the derivative may be referred to as the "absolute value derivative" and either the absolute value, the magnitude or a value indicating the absolute value may be used. Once it is determined that first fluid 13 has stopped flowing, the system is capable of ascertaining whether an occlusion in an exit line 22 or entrance line 23 has occurred or whether the source of fluid is depleted. Because the algorithm detects rapidly when fluid flow has stopped, the delay for detecting whether exit line 22 or entrance line 23 is occluded may be reduced by an order of magnitude with respect to the pric. art for such a system. A more detailed description of this method and its accompanying system will be found below. This system for determining when fluid has stopped flowing may also be operated in unison with a control system.

In a preferred embodiment, the closed loop control system regulates the pressure within the container. It attempts to adjust the pressure of the second fluid to a target pressure by comparing the measured pressure signal of the second fluid to the target pressure and controlling the opening and closing of an inlet valve 16 to adjust the pressure of the second fluid. The term "attempts" is used in a controls-theoretical sense. The inlet valve 16 connects the chamber to a pressurized fluid reservoir tank 17.

Detailed Description of the System for Determining if a Fluid is Flowing Further referring to Fig. I, in accordance with a preferred embodiment, fluid flows 8 through line 11 in which pumping mechanism 12 is located. The mechanism may be of a flexible membrane 12 which divides the line 11 and is attached to the inside of the line's inner sides 20. Membrane 12 can move up or down in response to pressure changes within chamber 11 and is the method by which fluid is transported through chamber 11. The membrane 12 is forced toward or away from the chamber's wall by a computer controlled pneumatic valve 16 which delivers positive or negative pressure to various ports (not shown) on the chamber 11. The pneumatic valve 16 is connected to a pressurized reservoir tank 17. By "pressurized", it is meant that the reservoir tank contains a fluid 14 which is at a pressure greater than the fluid 13 being transported.

Pressure control in line 11 is accomplished by variable sized pneumatic valve 16 under closed loop control. Fluid 13 flows through the chamber in response to the pressure differential between first fluid 13 being transported and second fluid 14 which is let into the line from the reservoir tank. The reservoir tank 17 releases a time varying amount of second fluid 14 into the chamber. As the pressure of the fluid from the reservoir tank becomes greater, membrane 12 constricts the volume in which the transported fluid 13 is located, forcing transported fluid 13 to be moved. The flow of the fluid is regulated by processor 18 which compares the pressure of the second fluid to a target pressure signal and regulates the opening and closing of valve 16 accordingly. When fluid 13 flow stops, valve 16 will close after the pressure is at its target. This indicates either that the membrane or pumping mechanism 12 is at the end of its stroke or the fluid line is occluded. After the fluid flow ceases, the pressure within line 11 will remain at a constant value. Thus, when the pressure signal is differentiated, the differentiated value will be zero. With this information a system has been developed to determine if the fluid flow has stopped.

Description of the Control System and the Feedback Loop For the following section refer to the flow chart of Fig. 3 and to Fig. 1. The control system operates in the following manner in a preferred embodiment. The second fluid/air pressure is measured within the chamber through transducer 15 (step 302). The pressure signal that is produced is fed into processor 18 that compares the signal to the target pressure signal and then adjusts valve 16 that connects pressurized fluid reservoir tank 17 -9and chamber 11 so that the pressure of the second fluid/air in chamber 11 moves toward the target pressure (step 304). The target pressure in the closed loop system is a computer simulated DC target value with a small time varying component superimposed. In the preferred embodiment, the time varying component is an AC component and it is a very small fraction of the DC value. The time varying component provides a way to dither the pressure signal about the desired target value until the stroke is complete. Since the target pressure has the time varying signal superimposed, the difference or differential between the pressure signal and the target value will never remain at zero when fluid is flowing in the line. The target pressure will fluctuate from time period to time period which causes the difference between the pressure and the target pressure to be a value other than zero while fluid is flowing.

When a higher pressure is desired, indicating that the pressure in the chamber 11 is below the target pressure, valve 16 opens allowing the pressurizing fluid, which may be air 14 in a preferred embodiment, to flow from the reservoir tank to the chamber (step 306).

The reservoir tank need not be filled with air: The reservoir tank 17 can be filled with any fluid, referred to as the second fluid 14, which is stored at a greater pressure than the first fluid 13, which is the fluid being transported. For convenience of the description the second fluid will be referred to as "air". As long as there is fluid flow of first fluid 13, valve 16 must remain open to allow air 14 to flow into chamber 11 so that constant pressure is maintained. When a lower pressure is targeted, which indicates that the pressure is greater than the target pressure, valve 16 does not open as much (step 308).

When fluid stops moving valve 16 closes completely. Fluid is allowed to enter or exit chamber 11 depending on the change in pressure.

Detailed Description of the System and Method of Measuring Whether Fluid Flow has Stopped Referring to Fig. 2A the method for determining when a fluid has stopped flowing in a line is described in terms of the apparatus shown in Fig. 1. First in one embodiment, he pressure of the second fluid is measured within the chamber by the transducer which takes a pressure reading (step 202). Fig. 2B shows a graphical representation of step 202 of Fig. 2A which is the pressure signal of the second fluid graphed with respect to time.

10 Each period, the pressure of the second fluid changes so long as membrane 12 is not at the end of its stroke due to the AC component that is superimposed upon the DC target pressure. The AC component causes valve 16 to open and close from period to period, so that the pressure of the second fluid 11 mimics the AC component of the target pressure and is modulated. The pressure change between periods will not be equal to zero, so long as fluid continues to flow.

The measured pressure is sent to processor 18 which stores the information and differentiates the measured pressure signal with respect to the set time interval (step 204).

Fig. 2C shows a graphical representation of step 204 of Fig. 2A which is the derivative of step 202 graphed with respect to time.

Because the AC component of the target pressure causes inlet valve 16 to adjust the actual pressure of the air/second fluid 14 within chamber 11 during the stroke, the pressure differential will change between each time interval in a likewise manner. When pumping mechanism/membrane 12 reaches the end of stroke the pressure differential (dp) per time interval will approach zero, when the fluid stops flowing.

Processor 18 then takes the absolute value of the differentiated pressure signal (step 206). Fig. 2D shows a graphical representation of step 206 of Fig. 2A which is the magnitude of step 204 graphed with respect to time.

The absolute value is applied to avoid the signal from crossing through zero.

During periods of fluid flow, the superimposed time varying signal on the target pressure may cause the target value be larger during one period than the actual pressure and then smaller than the actual pressure in the next period. These changes will cause the valve to open and close so that the actual pressure mimics the time varying component of the target pressure. From one period to the next the differential of the actual pressure signal, when it is displayed on a graph with respect to time may cross through zero. Since a zero pressure reading indicates that fluid has stopped flowing, a zero crossing would indicate that fluid has stopped flowing even when it had not. When the absolute value is applied the magnitude of the signal results and this limits the signal results to positive values.

The pressure signal is then low pass filtered to smooth the curve and to remove any high frequency noise (step 208). The filter prevents the signal from approaching zero 11 until the end of stroke occurs. Fig. 2E shows a graphical representation of step 208 of Fig.

2A which is step 206 low pass filtered and graphed with respect to time.

If the filtered signal falls below a predetermined threshold the fluid has stopped flowing and either the membrane has reached the end of its stroke or the fluid line is occluded (step 210). The threshold value is used as a cutoff point for very small flow rates.

Low flow rates are akin to an occluded line. The threshold is set at a value that is above zero and at such a level that if the signal is above the threshold, false indications that the fluid has stopped will not occur. The threshold is determined through various measurement tests of the system and is system dependent.

Indicating if a Fluid Line is Occluded In a preferred embodiment, when the end of stroke is indicated by processor 18, the system may then determine if one of fluid lines 22,23 is occluded. This can be accomplished through a volumetric fluid measurement. The air volume is measured within line 11. The ideal gas law can be applied to measure the fluid displaced by the system.

Since pressure change is inversely proportional to the change in volume within a fixed space, air volume in pumping chamber 11 can be measured using the following equation.

Va=Vb(Pbi-Pbf)/(Paf-Pai) Where Va=pump chamber air volume Vb= reference air volume (which is known) ,Pbi=initial pressure in reference volume Pbf=final pressure in reference volume Paf=final pressure in pump chamber Pai=initial pressure in pump chamber Once the volume of air is calculated the value of the air volume at the beginning of the stroke is then recalled. The differential between the previous and current volume measurements equates to the volume of fluid 13 that is displaced. If the amount of fluid 3 that is displaced is less than half of what is expected, entrance or exit line 22,23 is considered occluded and an alarm can be sent either visually or through sound or both. The entire process may be performed in less than five seconds as opposed to the prior art which 12 may take upwards of thirty seconds to determine if a fluid line is occluded. The algorithm is very robust over a wide range of fill and delivery pressures and is intolerant to variations in the valve used to control pressure.

It is possible to use the ideal gas law to create a system to measure a no flow condition based on parameters beside pressure. If energy is allowed to enter the system through the second fluid in a time varying manner the change in volume, or temperature may be measured with respect to the second fluid. If the change approaches zero for the volume or temperature the first fluid will have stopped flowing.

Although various exemplary embodiments of the invention have been disclosed, it should be apparent to those skilled in the art that various changes and modifications can be made which will achieve some of the advantages of the invention without departing from the true scope of the invention. These and other obvious modifications are intended to be covered by the appended claims.

For the purposes of this specification it will be clearly understood that the word "comprising" means "including but not limited to", and that the word "comprises" has a corresponding meaning.

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Claims (12)

1. A computer program for determining a change in a 00 first fluid's flow rate within a line, the computer program comprising: program code for applying a time varying amount C- of energy to a second fluid separated from the first fluid by a membrane; Sprogram code for measuring a pressure of the c-i second fluid in response to the applied energy; and program code for determining when flow of the c-i first fluid has stopped based at least on the pressure of the second fluid.

2. A computer program as defined by claim 1, wherein the second fluid is gas.

3. A computer program as defined by claim i, wherein the second fluid is air.

4. A computer program as defined by claim 1, wherein the first fluid is blood.

A computer program as defined by claim 1, wherein the first fluid is dialysis fluid.

6. A computer program as defined by claim 7, wherein the program code for determining a change in the first fluid's flow rate includes: program code for determining a value corresponding to the derivative with respect to a timing period of the pressure of the second fluid creating a derivative value; program code for determining a value corresponding to the magnitude of the derivative value creating a magnitude derivative; program code for low pass filtering the magnitude H:\pauda\keep\SPECI\P47769 AMENDED 12-O5-06.doc 8/06/06 IC 14- \O O derivative creating a low pass output; and Sprogram code for comparing the low pass output to ;Za threshold value for determining that the first fluid's 00 flow has stopped.

7. A computer program as defined by claim 6, the Ci computer program further comprising: program code for taking the difference between Sthe pressure of the second fluid and a target value; and program code for varying inlet valve in response to the difference between the pressure of the second fluid and the target value for changing the pressure of the second fluid toward the target value.

8. A computer program as defined by claim 7, wherein the target value comprises a time varying component having an amplitude and a DC component, the amplitude of the time varying component being less than the DC component.

9. A computer program according to claim 1, further including program code for activating an indicator if the first fluid has stopped flowing.

A fluid management system for dispensing an amount of a first fluid and monitoring a state of flow of the first fluid, the system comprising: a chamber having an inlet and an outlet and a septum separating the first fluid and a second fluid; a reservoir tank containing the second fluid in fluid communication with the chamber; a valve disposed between the reservoir tank and the chamber; an energy imparter for applying a time varying amount of energy on the second fluid the energy imparter comprising a membrane disposed within the chamber between the first fluid and the second fluid for pumping the first fluid in response to a pressure differential between the H&\pau1a\keep\SPECI\P47769 AMENDED 12-05-06.doc 8/06/06 S- 15 \O O first fluid and the second fluid; Sa transducer for measuring a pressure of the second fluid within the chamber and creating a signal of 00 the pressure; and a processor for determining whether the first fluid has stopped flowing based on the signal.

11. A system according to claim 10, further including c an indicator activated if the first fluid has stopped M 10 flowing.

12. A system according to claim 10, wherein the processor further controls opening and closing of the valve. Dated this 8th day of June 2006 DEKA PRODUCTS LIMITED PARTNERSHIP By their Patent Attorneys GRIFFITH HACK Fellows Institute of Patent and Trade Mark Attorneys of Australia H,\pau1a\keep\SPECI\P47769 AMENDED 12-05-06.doc 8/06/06