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    • 专利摘要:
    METHOD FOR OBSTRUCTION DETECTION. Methods for optimizing the accuracy of the obstruction sensor baselines in an infusion pump are described. An infusion pump includes logic to make a decision against continuous growth to determine whether a new administration set has been installed, after access to the administration set has been made. If so, new baselines for the obstruction sensor are established. If not, the current baselines are maintained. The logic of the decision against continuous increase may depend on the value of a baseline delta equal to a difference between the upstream sensor signal and the downstream sensor signal. In another aspect, a baseline of the upstream obstruction sensor is shifted in correspondence to decreases in the upstream sensor signal that occur while an infusion pump pumping mechanism is not operating, to compensate for the displacement of the upstream signal. sensor.
    公开号:BR112014021812B1
    申请号:R112014021812-9
    申请日:2013-03-07
    公开日:2020-12-29
    发明作者:Scott A. Denis；Silke Williams
    申请人:Zevex, Inc.；
    IPC主号:
    专利说明:

    FIELD OF THE INVENTION
    [0001] The present invention relates to the field of infusion pumps for medical use and, more particularly, to methods for detecting an obstruction or blockage in the pipeline through which the fluid is pumped. Background of the Invention
    [0002] Programmable infusion pumps for releasing nutritional fluids and medications to patients, according to predetermined parameters for fluid release, have wide use. One type of infusion pump is a peristaltic pump arranged along a flexible connection tubing, which carries fluids from a fluid source to the patient. The peristaltic pump has a pumping mechanism to progressively press successive portions of the tubing, so that the fluid flows through the tubing, in a flow direction directed at the patient. In a common arrangement, the pumping mechanism includes a motorized wheel with protrusions or radial cylinders that engage a segment of the tubing arranged around a circumferential portion of the wheel. As the wheel turns, fluid is pumped through the tubing to the patient. The pipe segment arranged around the pump wheel can be maintained in a U-shaped configuration by a cassette designed to be received in a channel or receptacle area of the pump. The cassette can provide terminals for connecting a pipeline inlet line from the fluid source, and a pipeline outlet line that goes to the patient, at opposite ends of the U-shaped pipe segment received by the pump. In this specification, the terms "upstream" and "downstream" are in reference to the direction of fluid flow caused by the pumping mechanism. For example, the pipe inlet line is "upstream" of the pumping mechanism, and the pipe outlet line is "downstream" of the pumping mechanism.
    [0003] A recognized concern, especially when pumping viscous nutritional fluids for enteral feeding, is the formation of blockages ("obstructions") inside the tubing, which can reduce or completely prevent the flow. As a safety measure, it is known to use a pair of obstruction sensors in the infusion pump. An upstream obstruction sensor is arranged to interact with the pipeline at an upstream location in relation to the pumping mechanism, and a downstream obstruction sensor is arranged to interact with the pipeline at a downstream location in relation to to the pumping mechanism. Obstruction sensors can include transducers or strain gauges, which detect the deflection of the flexible pipe wall caused by a local pressure differential (either increase or decrease in pressure) in relation to an equilibrium fluid pressure inside the pipe, and provide an electronic signal that indicates the deflection. For example, if an obstruction forms at a location in the downstream pipeline, between the pump and the patient, an outward expansion or deflection in the pipe wall will be detectable by the downstream obstruction sensor. On the other hand, if an obstruction is formed at a location in the upstream pipeline between the fluid source and the pump, the continued operation of the pumping mechanism will create a vacuum between the location of the obstruction and the pumping mechanism, and a deflection inward on the pipe wall will be detectable by the upstream obstruction sensor.
    [0004] The signals coming from the upstream and downstream obstruction sensors are monitored and compared to the respective signal baselines to detect the obstruction. The baseline of the upstream sensor signal is the signal provided by the upstream sensor that corresponds to a fluid pressure equilibrium condition at the upstream sensor location. Similarly, the baseline of the downstream sensor signal is the signal provided by the downstream sensor that corresponds to a fluid pressure equilibrium condition at the downstream sensor location. The upstream and downstream baselines can be established by an initialization routine performed when the pump is started. During the operation of the infusion pump, the respective differences between the upstream sensor signal and the upstream baseline, and between the downstream sensor signal and the downstream baseline are monitored. If a difference between the sensor signal and the corresponding baseline exceeds a predetermined threshold for a predetermined period of time, an upstream obstruction is detected. As will be understood, establishing and maintaining valid baselines for upstream and downstream obstruction sensors is essential for proper obstruction detection.
    [0005] A situation in which an invalid baseline can be inadvertently used occurs when an obstruction is detected, the pump is stopped, and a pump door is opened to give access to the cassette and piping, to allow replacing the clogged tubing. If a new pipe is not installed and the pump is restarted with the blocked pipe still installed, the start-up routine can be mislead and use the pressurized pipe to establish new baselines. This problem is called, in the art, "continuous increase" of the baseline.
    [0006] The displacement of the sensor can also interfere in the proper detection of the obstruction. During infusion protocols with a very low infusion speed, the pump motor can actually run for a very short time (for example, a "step", or increment, of the stepper motor per minute). When the pump motor is not running, it can be assumed that increases in the signal from the downstream sensor are due to displacement of the sensor, not a real increase in pressure caused by an obstruction in the downstream piping. Similarly, when the pump motor is not running, it can be assumed that decreases in the upstream sensor signal are due to sensor displacement, not a real decrease in pressure caused by an obstruction in the upstream pipeline. If changes attributable to sensor displacement are included in the calculation of the difference from the baseline of the associated sensor, false obstruction alarms can occur. SUMMARY OF THE INVENTION
    [0007] The present invention solves the problems mentioned above, and optimizes the detection of obstructions in infusion pump systems. As will be understood, the obstruction detection is made in relation to baseline signals from the upstream and downstream obstruction sensors. The present invention helps to ensure that suitable baseline values are used as a reference, so that obstruction detection prevents false positives while still detecting actual obstruction events.
    [0008] In one aspect, the invention presents a method for making a decision against continuous increase (antiratchet), by which it is determined, each time the pump door is opened, whether a new administration set has been installed ( (ie, cassette and tubing), or if a previous clogged administration set remains installed. This type of decision against continuous increase helps to solve the "continuous increase" problem mentioned in the background, since the previous baselines of the upstream and downstream sensors can be maintained if the decision against continuous increase determines that the set of Obstructed administration remains installed on the pump. On the other hand, if the decision against the continuous increase finds that a new administration set has been installed, new baselines for the sensors can be established. According to an embodiment of the present invention, the method includes calculating a baseline delta equal to a difference between the upstream sensor signal and the downstream sensor signal, and comparing the baseline delta to a delta of the predetermined minimum baseline, and the decision against continuous increase determines that the blocked pipe has not been replaced if the baseline delta is less than the minimum baseline delta. The minimum baseline delta can be determined based on historical baseline delta values stored by the infusion pump. The method may also include the step of comparing the signal from the downstream sensor to a predetermined limit for the downstream signal, with the decision against continuous increase determining that the blocked pipeline was not replaced if the signal from the downstream sensor is greater than the limit of the downstream signal.
    [0009] In another aspect, a method is presented to adjust a baseline of the sensor signal upstream in order to compensate for the sensor signal shift. Accordingly, a baseline of the upstream sensor signal corresponding to the fluid pressure balance at the upstream sensor site is shifted in correspondence to decreases in the upstream sensor signal that occur as a pump pumping mechanism infusion is not working.
    [0010] The invention additionally encompasses an infusion pump programmed to implement the methodology of the present invention. BRIEF DESCRIPTION OF THE VIEWS OF THE DRAWINGS
    [0011] The invention is described in detail below, with reference to the following figures:
    [0012] Figure 1 is a schematic representation of an infusion pump formed according to one embodiment of the present invention, showing the installation of a cassette and a pipe in the pump to illustrate the basic operation;
    [0013] Figure 2 is an electronic block diagram of the pump shown in Figure 1;
    [0014] Figure 3 is a schematic diagram illustrating in general the obstruction detection software stored and executed by the pump, according to an embodiment of the present invention;
    [0015] Figure 4 is a flow diagram of a pump start-up routine, according to an embodiment of the present invention;
    [0016] Figures 5A to 5B are a flow diagram of a pump reset routine, according to an embodiment of the present invention;
    [0017] Figures 6A to 6B are a flow diagram of a pre-motor obstruction check routine, according to an embodiment of the present invention;
    [0018] Figure 7 is a flow diagram of an obstruction check routine, according to an embodiment of the present invention;
    [0019] Figure 8 is a flow diagram of a post-motor obstruction check routine, according to an embodiment of the present invention;
    [0020] Figures 9A to 9G are a flow diagram of an obstruction detection routine, called by the obstruction check routine in Figure 7 and the post-motor obstruction check routine in Figure 8, according to a embodiment of the present invention;
    [0021] Figures 10A to 10B are a flow diagram of a routine against continuous increase, called by the obstruction detection routine of Figures 9A to 9G, according to an embodiment of the present invention;
    [0022] Figure 11 is a flow diagram of an obstruction baseline delta routine, called by the obstruction detection routine of Figures 9A to 9G, according to an embodiment of the present invention;
    [0023] Figures 12A to 12B are a flow diagram of a detected downstream obstruction routine, called by the obstruction detection routine of Figures 9A to 9G, according to an embodiment of the present invention;
    [0024] Figures 13A to 13B are a flow diagram of a detected upstream obstruction routine, called by the obstruction detection routine of Figures 9A to 9G, according to an embodiment of the present invention;
    [0025] Figure 14 is a flow diagram of an obstruction routine pending downstream, called by the obstruction detection routine of Figures 9A to 9G, according to an embodiment of the present invention; and
    [0026] Figure 15 is a flow diagram of an obstruction routine pending upstream, called by the obstruction detection routine of Figures 9A to 9G, according to an embodiment of the present invention. DETAILED DESCRIPTION OF THE INVENTION
    [0027] Figures 1 and 2 schematically represent a programmable infusion pump 10 incorporating the present invention. The infusion pump 10 includes a cabinet 12, a pump wheel or rotor 14 and a cassette receptacle 16 on an external face of the cabinet, and a door 18 connected to the cabinet so that it opens and closes on the cassette receptacle and the pump wheel. As shown in Figure 1, an administration set can be installed in association with the pump to transport fluid from a fluid source to a patient. The administration set includes an upstream pipe 4 going from the fluid source to the pump, a downstream pipe 8 going from the pump to a patient, a cassette 5 received in the cassette receptacle 16, and a U-shaped pipe segment 6 arranged around the pump wheel 14. The cassette 5 is configured with connection terminals 5U and 5D, to connect the upstream piping 4 to an upstream end of the pipe segment 6 and the downstream piping 8 to a downstream end. of the pipe segment 6, in order to complete a flow path from the upstream pipe to the downstream pipe by means of the pump.
    [0028] The pump wheel 14 is part of a pumping mechanism that works to cause the fluid to flow through the pipe in a desired flow direction. The pumping mechanism additionally includes an electric motor 20 connected to the pump wheel 14 and which functions to rotate the pump wheel around its axis. The pump wheel 14 has projections or radial cylinders (not shown) that interact with the pipe segment 6 arranged around a circumferential portion of the wheel. When the pump wheel 14 rotates, successive portions of the pipe segment 6 are progressively pressed to cause the fluid to flow through the pipe in a flow direction directed towards the patient. The flow rate of the infused fluid can be controlled by controlling the speed of the engine 20. Those skilled in the art will understand that variations in the peristaltic pumping mechanism described above are possible. For example, motor 20 can drive a cam element connected to a series of parallel projections or cylinders arranged side by side, so that the peristaltic pumping action is applied to a straight pipe segment, instead of a curved pipe segment. piping, as shown in Figure 1. The present invention is not limited to a specific pumping mechanism configuration.
    [0029] The infusion pump 10 is provided with an upstream obstruction sensor 22 at a location along the pipe segment 6, upstream of the pumping wheel 14, and a downstream obstruction sensor 24 at a location along of the pipe segment 6, downstream of the pumping wheel 14. Each of the upstream sensor 22 and the downstream sensor 24 provides a respective sensor signal indicating a respective local fluid pressure in the pipe. For example, the upstream and downstream sensors, 22 and 24, can be transducers or stress meters arranged to interact with an external wall of the pipe segment 6 to detect the deflection of the flexible pipe wall, caused by the pressure of fluid inside it, and provide an electronic signal proportional to the deflection. In one embodiment of the present invention, each obstruction sensor, 22 and 24, can be configured to generate a voltage signal within a range of 0 to 2,500 mV corresponding to the local pressure in the pipeline. In addition, as an example, the obstruction sensors, 22 and 24, can be calibrated mechanically and by digital potentiometers for displacement and voltage gain, in order to establish a baseline upstream at 1,250 mV, a line of initial downstream base at 750 mV, a differential of -34.5 kPa (-5 psi) from the upstream baseline to 950 mV (300 mV below the upstream baseline), a differential of +103.4 kPa (+15 psi) of the baseline downstream at 1,150 mV (400 mV above the baseline downstream), and a differential of +124.1 kPa (+18 psi) from the baseline downstream at 1,250 mV ( 500 mV above the downstream baseline).
    [0030] The infusion pump 10 additionally includes a door sensor 26, arranged to cooperate with a trigger element 28 on the door 18 to generate an electrical signal indicating the current state of the door as open or closed.
    [0031] As seen in Figure 2, the infusion pump 10 is configured to allow a user to select or create and then execute an infusion protocol determining the amount of fluid to be delivered to the patient, and the speed at which the fluid needs to be supplied. The infusion pump 10 includes a microprocessor 30 connected to a user interface 32 that has input devices such as a key pad, keys and controls per selector. The infusion pump 10 also includes a screen 34 connected to microprocessor 30. Screen 34 can be a touchscreen monitor, sometimes acting as part of user interface 32. Microprocessor 30 is connected to a controller of the motor 36 to drive electric motor 20 in order to administer a chosen protocol. One or more memory modules 38 are connected or integrated with microprocessor 30 in order to store instructions executable by the microprocessor to control the operation of the pump. The stored instructions can be organized into software routines. Among the stored software routines are routines that work to detect obstructions in accordance with the present invention. These routines are described in detail below. For the purposes of the obstruction detection functionality, the microprocessor 30 is connected to the upstream obstruction sensor 22 and to the downstream obstruction sensor 24. The microprocessor 30 also receives the signal from the port sensor 26. The circuit is shown from analog to digital conversion 23, for converting the analog voltage signals from the obstruction sensors and the door sensor to digital form, for use by the microprocessor 30. The infusion pump 10 can also include an audible signal generator 35 connected to microprocessor 30.
    [0032] Now attention is directed to Figure 3, which generally illustrates the obstruction detection software stored and executed by the pump, according to a modality of the present invention. In the mode shown, the logic for evaluating the signals coming from the upstream sensor 22 and the downstream sensor 24, and determining when an obstruction is present, is performed by several software routines synchronized with the activity of the motor 20, by means of a pump status machine 104. When starting the pump, an initialization routine 100 ("OcclusionInit") is performed. An obstruction sensor reset routine ("OcclusionReset") is performed when a therapy protocol or pump priming is initiated. Then, the pump status machine 104 manages execution based on the status of pump 10. Pump 10 has a neutral motor state 106, in which motor 20 is not pumping. The selected protocol program determines when engine 20 needs to be activated and deactivated to obtain the desired flow for the protocol. Under the pump status machine 104, when the pump is in a pre-motor state 108, just before the activation of motor 20, it is called a pre-motor routine ("OcclusionPreMotorCheck"). While pump 10 is in a motor pumping state 110, in which motor 20 is activated and pumping fluids, state machine 104 handles obstruction detection according to a main obstruction check routine ("OcclusionCheck"). As soon as the motor 20 is deactivated and leaves the pumping state 110, the pump enters a post motor state 112, in which the obstruction detection logic is handled by a post motor motor ("OcclusionPostMotorCheck"). The obstruction detection software is executed periodically, whenever new signal values upstream and downstream are available from analog to digital converters 23, for example every 250 ms. The readings from the analog to digital converters 23 can be synchronized with the steps of the motor, so that the data is sampled more frequently when the motor is running at a higher rotation speed.
    [0033] The OcclusionInit routine is illustrated in Figure 4. In block 120, obstruction sensors 22 and 24 are temporarily disabled. Block 122 sets the value of an obstruction status variable OCC_STATUS to a value that indicates no obstruction (for example "OK"), and block 124 sets all obstruction timers to zero. As will be explained later, obstruction timers track how long a specific obstruction signal has exceeded a predetermined threshold representing a difference from the obstruction sensor's baseline. In block 126, the upstream and downstream obstruction signal limit variables, specifically UP_THRESH and DN_THRESH, are set to zero. UP_THRESH tracks the difference in the signal from the upstream obstruction sensor to the baseline of the upstream sensor, and DN_THRESH tracks the difference in the signal from the downstream obstruction sensor to the baseline of the downstream sensor. In essence, block 126 causes a respective new baseline to be established for each obstruction sensor, which is equivalent to the current value of the sensor signal. In block 128, the Boolean variables are adjusted to the initial values. These include bARREQ and bADDBLDELT, which are set to TRUE. These also include bUPREBL, bDNREBL and bTAKEPREBL, which are set to FALSE. The significance of these variables will be evident later in this description. According to block 130, historical data from the "baseline delta" is retrieved from memory 38. The baseline delta is defined as the difference between the baseline of the upstream signal and the baseline of the downstream signal. A variable designated as BL_DELTA_MIN is set to zero in block 132. Finally, in block 134, obstruction sensors 22 and 24 are enabled. Upon completion, OcclusionInit, which can be a Boolean function, returns a value of TRUE.
    [0034] The OcclusionReset routine is shown in Figures 5A and 5B. Decision block 140 checks whether a previous sensor failure has occurred. If no sensor failure has occurred, the OCC_STATUS value is reset to OK by block 142. Variables that are specifically not reset include the previous limits UP_THRESH and DN_THRESH, LAST_UP and LAST_DN corresponding to the last signal values sampled from the upstream sensor 22 and the downstream sensor 24 before the last engine stop, and an engine step counter to count the rotational increments of the engine 20. Block 146 resets all obstruction timers to zero. In block 148, the angular coefficient history of the signals from the upstream and downstream pressure sensors is reset. In block 150, the UP_AVG and DN_AVG variables are reset to maintain the moving averages of the upstream and downstream sensor signals sampled.
    [0035] The OcclusionReset routine then continues to a decision block 152 that directs the flow based on whether cassette 5 was accessible while the pump was stopped. The cassette was accessible if the door sensor 26 indicates that door 18 was opened after the pump had stopped. If not, the OcclusionReset routine is terminated. If the cassette was accessible, there is a possibility that a new cassette and an administration set have been installed, and the flow continues to block 154 to redefine the Boolean variables bARREQ, bADDBLDELT, bUPREBL and bDNREBL, as indicated. Decision block 156 then determines whether the administration set was unobstructed when the pump was last stopped, by checking the OCC_STATUS value. If there is no previous obstruction, it can be assumed that there is no problem of continuous increase, and the boolean variable bTAKEPREBL is set to TRUE in block 158, so that new baselines for obstruction sensors are established. The execution of OcclusionReset is then complete.
    [0036] Figures 6A to 6B illustrate the OcclusionPreMotorCheck routine. An initial decision block 160 ensures that execution continues only when the UP_SAMPLE upstream sensor signal and the currently sampled DN_SAMPLE downstream sensor signal are considered valid. For example, the readings of UP_SAMPLE and DN_SAMPLE can be compared to a predetermined upper or upper limit. If UP_SAMPLE and DN_SAMPLE are valid, the routine calculates the UP_AVG and DN_AVG moving averages of the upstream and downstream sensor signal values according to block 162. For example, the UP_AVG and DN_AVG moving averages can be calculated for the last three sampled readings from the upstream sensor 22 and from the downstream sensor 24, respectively, and are continuously updated as new sensor readings are sampled. In block 164, the motor step counter is started in order to record the motor steps.
    [0037] Decision block 166 branches the flow based on whether the boolean variable bTAKEPREBL has a value of TRUE or FALSE. The value of bTAKEPREBL determines whether new baselines for the sensors are established. If the cassette was previously accessible but there was no previous obstruction, then bTAKEPREBL will be set to TRUE. If decision block 166 finds bTAKEPREBL equal to TRUE, then the UP_THRESH and DN_THRESH limits are set to zero in block 168, effectively establishing UP_AVG and DN_AVG as the respective sensor baselines. Also in block 168, the value of bTAKEPREBL is changed from TRUE to FALSE. The flow then jumps to block 179, where LAST_UP and LAST_DN are defined as equal to UP_AVG and DN_AVG, respectively.
    [0038] If decision block 166 determines that bTAKEPREBL is FALSE, then the current baselines are maintained, but can be adjusted to take into account the possible shift in the upstream and downstream sensor signals while the engine was idle. If the voltage signal from the downstream sensor 24 increased while the motor 20 was switched off, it can be assumed that the signal change is attributable to the signal shift of the sensor, not to a real pressure change. Consequently, the DN_THRESH value, which represents the current difference between pressure signals from the downstream sensor's baseline, is not changed to reflect increases in the downstream sensor signal while the engine was off. In essence, this is the same as adjusting the downstream baseline to account for displacement. If an increase in downstream pressure occurs, decision block 169 has a NO result and the flow jumps to decision block 172. If, on the other hand, the signal from the downstream sensor decreases while motor 20 is idle, it can - it is assumed that some pressure has been released and DN_THRESH should be adjusted to reflect the pressure drop. For this situation, decision block 169 offers a result of YES and DN_THRESH is adjusted according to block 170. According to decision block 172 and block 174, if the adjustment of DN_THRESH results in a negative value, DN_THRESH is set to zero. In other words, DN_THRESH is not allowed to be negative.
    [0039] The change in the UP_THRESH upstream limit is handled by blocks 176 and 178. Decision block 176 determines whether the upstream pressure signal increased while the engine was off. If not, and if there was a decrease in pressure instead while the engine was off, it is assumed that the decrease is a result of the sensor signal shift, and not the result of a real decrease in pressure (an increase in vacuum ). In this case, decision block 176 has a result of NO and UP_THRESH is kept where it is, despite the change in the pressure signal, in essence displacing the baseline upstream to take into account the sensor displacement. The flow jumps to block 179. However, if decision block 176 finds that the signal from the upstream sensor has increased while the engine was off, it is assumed that some vacuum has been released and UP_THRESH is adjusted in block 178. It is allowed that the UP_THRESH upstream limit has a negative value, which ensures that a high pressure that remains for some time after port 18 has been closed does not cause false baseline adjustments.
    [0040] Finally, as indicated by block 179, OcclusionPreMotorCheck sets LAST_UP and LAST_DN as equal to the respective UP_AVG and DN_AVG moving averages.
    [0041] Figure 7 illustrates the flow of the OcclusionCheck routine corresponding to the motor pumping state 110. An initial decision block 180 verifies that the sensor signals UP_SAMPLE and DN_SAMPLE, currently sampled, are considered valid. Block 182 recalculates the UP_AVG and DN_AVG moving averages. Finally, block 184 calls another routine, DetectOcclusion, which determines whether an obstruction is present in the pipeline. The DetectOcclusion routine is described in detail below, with reference to Figures 9A to 9G.
    [0042] The PostMotorCheckRoutine routine, corresponding to a post-motor state 112, is diagrammed in Figure 8 and is very similar to the OcclusionCheck routine. An initial decision block 200 checks whether the sensor signals UP_SAMPLE and DN_SAMPLE currently sampled are considered valid. Another decision block 202 ensures that the motor 20 is completely off, by checking the state of the motor controller 36. Block 204 recalculates the moving averages UP_AVG and DN_AVG. Finally, block 206 calls the DetectOcclusion routine.
    [0043] The DetectOcclusion routine will now be described in association with Figures 9A to 9G. Block 220 sets the variables UP_SLOPE and DN_SLOPE to zero, designed to monitor the angular coefficient of the upstream and downstream sensor signals. Block 220 also adjusts to zero UP_DIFF and DN_DIFF, these variables being used to store pressure changes upstream and downstream, respectively, since the last obstruction check. In block 222, the number of steps of the motor since the last obstruction check is determined. Block 224 calculates UP_DIFF as equal to LAST_UP minus UP_SAMPLE, and DN_DIFF as equal to DN_SAMPLE minus LAST_DN. The calculated pressure differences are then added to the respective obstruction limits according to block 226. Decision block 228 and block 230 prevent the downstream limit DN_THRESH from being negative, effectively shifting the baseline down to downstream.
    [0044] Going to Figure 9B, in block 232, the current sensor signal values are kept as LAST_UP and LAST_DN for later reference. According to block 234, the signal angular coefficients UP_SLOPE and DN_SLOPE are calculated over the last complete rotation of the engine, using the pressure difference data stored in an angular coefficient history buffer. As an example, in this modality, a complete rotation of the motor would correspond to twelve steps of the motor. Then, in decision block 236, the boolean variable bARREQ is used as a reference to determine whether the AntiRatchet routine should be called. If bARREQ is TRUE, then the flow branches to block 238, in which the AntiRatchet routine of Figures 10A to 10B is called. After the call to AntiRatchet, bARREQ is set to FALSE at block 240. If decision block 236 finds that bARREQ is FALSE, then the flow proceeds to decision block 242 for additional logic used to apply sensor offset compensation. If the angular coefficient of the upstream sensor signal is substantially flat and there is no pending upstream obstruction (the pending of an obstruction is described later, in relation to Figures 14 and 15), then an UP_FLATCOUNT variable that consecutively accompanies the UP_SLOPE is below a slope limit (it is substantially flat) it is increased in block 244 and the flow continues to decision block 245. If UP_FLATCOUNT is greater than or equal to a chosen limit (for example, 50) indicating stability in the slope , then the current upstream pressure signal can serve as the new upstream baseline, by setting UP_THRESH to zero in block 246. Additionally, in block 246, the boolean variable bUPREBL is set to TRUE, to indicate that the upstream sensor had its baseline readjusted. On the other hand, if decision block 242 provides a NO result, the baseline readjustment of the upstream sensor is bypassed and UP_FLATCOUNT is set to zero in block 248. Continuing to Figure 9C, it should be understood that the block decision 250, block 251, decision block 252, block 253 and block 254 are analogous to decision block 242, block 244, decision block 245, block 246 and block 248, respectively, but apply to the downstream sensor and the downstream limit.
    [0045] Decision block 256 allows the addition of a new baseline delta value to the baseline delta history buffer, if both the upstream and downstream sensors had their baselines readjusted, as indicated by the boolean variables bUPREBL and bDNREBL, and if the value of the boolean variable bADDBLDELT is TRUE. If these conditions are met, block 258 sets bADDBLDELT to FALSE and block 260 calls an OccBaselineDelta routine to add a baseline delta value to the history buffer, and to calculate the minimum baseline delta BL_DELTA_MIN initialized in the block initialized in the block. 132 of the OcclusionInit routine and used by the AntiRatchet routine. The OccBaselineDelta routine is illustrated in Figure 11, and begins with block 320 calculating the baseline delta BL_DELTA as equal to the baseline UPBL minus the baseline downstream DNBL. In block 322, BL_DELTA is added to the history buffer. Blocks 324 through 330 are programmed to determine a suitable value for BL_DELTA_MIN, based on historical information from the baseline delta to the pump. In the modality described here, the determination of BL_DELTA_MIN may depend on how much historical information of the baseline delta is available in the history buffer. For example, if there are at least some chosen number of baseline delta values in the history buffer to calculate a significant standard deviation of the data, for example at least twenty values, then decision block 324 directs the BL_DELTA_MIN calculation of according to blocks 326 and 328, where BL_DELTA_MIN is set to equal the average of the historical baseline delta values BL_DELTA_AVG minus 3.3 times the standard deviation of the baseline delta values. If there is less than the chosen limit number of baseline delta historical values, decision block 324 directs the flow to block 330, which sets BL_DELTA_MIN equal to 0.6 times BL_DELTA_AVG.
    [0046] Attention is again directed to Figure 9C. The flow continues at block 242 to set OCC_STATUS to OK. Proceeding to Figure 9D, decision block 262 determines if there is an obstruction downstream by executing a Boolean exit routine DownstreamOcclusionDetected that returns TRUE if an obstruction is found downstream. The DownstreamOcclusionDetected logic is described in Figures 12A to 12B. In the present mode, a downstream obstruction is detected if the downstream pressure reading rises to 103.4 kPa (15 psi) above the downstream baseline, and remains above that level for 30 seconds, or if the pressure reading downstream rise to 124.1 kPa (18 psi) above the downstream baseline, and remain above that level for 5 seconds. The two timed criteria are called, in the present invention, "bands" of obstruction. The logic in Figures 12A to 12B is configurable to evaluate one or more obstruction bands, depending on the design choice. In the exemplary modality now described, there are two obstruction bands downstream, but only one obstruction band can be used (this is the case for the upstream obstruction detection scheme described below), or more than two obstruction bands can be used. be used. In Figures 12A to 12B, the flow is iterative from one lane to the next, with the specific obstruction strip being accompanied by an integer number "i", and the total number of downstream obstruction strips is stored under the form of a DNBANDS parameter. The pressure level or the limit for obstruction in a given range "i" is stored as DN_RANGE (i). Therefore, in the present example, DN_RANGE (1) corresponds to 103.4 kPa (15 psi), DN_RANGE (2) corresponds to 124.1 kPa (18 psi) and DNBANDS = 2. The respective timers for each range are designated DN_TIMER ( i), and the respective time limits for each track are stored as DN_OCCTIME (i). Consequently, in the present example, DN_OCCTIME (1) is equal to 30 seconds and DN_OCCTIME (2) is equal to 5 seconds.
    [0047] DownstreamOcclusionDetected sets a boolean obstruction detection variable, bOCCDETECTED, to FALSE in block 340. This variable will be changed to TRUE if the obstruction is detected according to the criteria of at least one obstruction range. The index counter "i" is initialized by block 342 to be equal to the total number of tracks downstream DNBANDS, thus starting the evaluation of the outermost obstruction band. Decision block 344 checks whether the downstream limit DN_THRESH has reached or exceeded DN_RANGE (i). If so, decision block 346 checks whether DN_TIMER (i) is at zero. If DN_TIMER (i) is at zero, block 348 starts DN_TIMER (i). If, however, DN_TIMER (i) is already counting (not at zero), then decision block 350 compares DN_TIMER (i) to DN_OCCTIME (i). If the DN_TIMER (i) exceeds the DN_OCCTIME (i) time limit, then a downstream obstruction is detected and block 352 sets bOCCDETECTED to TRUE. If decision block 344 finds that DN_THRESH did not reach or exceed DN_RANGE (i), then the flow continues directly to decision block 354, to verify that DN_TIMER (i) is greater than zero. If so, DN_TIMER (i) is reset to zero in block 356. Decision block 358 determines whether there are more obstruction ranges to evaluate. If the index counter "i" is greater than 1, then "i" is decremented by 1 in block 359, and the flow returns to decision block 344 to repeat the logic for the next downstream obstruction band. If the index counter "i" is equal to 1, then all obstruction ranges downstream have been evaluated and the bOCCDETECTED value is returned by the routine.
    [0048] Now returning to decision block 262 of the DetectOcclusion routine, if an obstruction is detected downstream, any alarm is suppressed until the AntiRatchet routine has had a chance to be executed. This is done by checking the value of bARREQ in decision block 264. If bARREQ is FALSE, then AntiRatchet has already been executed in block 238 and the obstruction event data is recorded according to block 266, and OCC_STATUS is set to a value that indicates an obstruction downstream (for example "DOWN_OCC") according to block 268.
    [0049] Decision block 270 in Figure 9E determines whether the downstream baseline is outside a predetermined range. The intervals for the baselines both upstream and downstream can be established and applied taking into account the relevant sensor signal intervals and obstruction range limits. In the present example, an interval that requires the downstream baseline to be less than 1,950 mV safely allows an additional +500 mV (18 psi) of pressure to be detected within the 2,500 mV sensor signal range. Also by way of example, an interval that requires the upstream baseline to be greater than 300 mV allows a pressure drop of -300 mV (-5 psi) to be detected. Decision block 270 can call a Boolean routine DownstreamOutOfRange to check if the baseline is outside the predetermined range. If so, this condition is treated in the same way as a downstream obstruction, as indicated by blocks 272 to 276, which correspond substantially to blocks 264 to 268 described above. The DownstreamOutOfRange routine mentioned is considered a simple routine for those skilled in programming, and is not further described in this document.
    [0050] The logic for detecting obstruction downstream, illustrated by Figures 9D to 9E (blocks 262 to 276) is essentially repeated for the detection of obstruction upstream, as can be understood from Figures 9F to 9G (blocks 278 to 292). The UpstreamOcclusionDetected routine, called by decision block 278, is represented in Figures 13A to 13B, being very similar to the DownstreamOcclusionDetected routine in Figures 12A to 12B and, consequently, the detailed description of blocks 360 to 378 is omitted from this document. . It should be noted that, in the present example mode, only an upstream obstruction band is defined. More specifically, an upstream obstruction is detected if the upstream pressure reading drops at least 34.5 kPa (5 psi) below the baseline of the upstream sensor, and remains below that level for 1 second or more. Of course, if desired, more than one upstream obstruction band can be defined.
    [0051] As mentioned above, decision blocks 244 and 255 (see Figures 9B and 9C) make a determination based, in part, on whether an upstream or downstream obstruction is "pending". A pending obstruction refers to the situation in which the obstruction pressure limit has been reached, and the obstruction timer in at least one of the obstruction ranges is counting towards the time period criterion for the range. For example, for the downstream obstruction range where the line pressure must meet or exceed 103.4 kPa (15 psi) for 30 seconds, a pending obstruction exists when the range timer is between 0 and 30 seconds. An OcclusionPendingDownstream routine to assess whether there is a pending obstruction downstream is shown in Figure 14, and a similar OcclusionPendingUpstream routine to assess whether there is a pending obstruction upstream is shown in Figure 15. Block 380 of OcclusionPendingDownstream sets a boolean variable bPENDING to FALSE , and block 382 initializes the index counter "i". The flow is repeated through each obstruction band "i", checking if DN_TIMER (i) is greater than zero in decision block 384 and, if so, setting bPENDING to TRUE in block 386. Decision block 388 determines whether there is another band of obstruction. If "i" is equal to the total number of obstruction strips downstream, then there are no more obstruction strips and the routine returns a bPENDING value where TRUE indicates a pending obstruction downstream. If there is another range, the index counter "i" is incremented in block 389, and the flow returns to decision block 384 to evaluate the next obstruction range. OcclusionPendingUpstream in Figure 15 works in a similar way, with blocks from 390 to 399 of OcclusionPendingUpstream being analogous to blocks from 380 to 389 of OcclusionPendingDownstream. The routines shown in Figures 14 and 15 can be called by blocks 250 and 244, respectively, to determine the obstruction pending.
    [0052] Reference is again made to Figure 9B, in which a routine called AntiRatchet is called in block 238 of DetectOcclusion. Each time port 18 is opened and closed, there is a possibility that a new administration set has been installed, in which case new baselines upstream and downstream need to be established. However, if port 18 is opened and closed, but the administration set is not replaced, then it is important to maintain the existing upstream and downstream baselines and not to establish new baselines for the pipeline that is already pressurized due to previous obstruction. The AntiRatchet routine, illustrated in Figures 10A to 10B, offers the logic for deciding whether to maintain the existing baselines of the sensors or establish new baselines.
    [0053] Block 300 of AntiRatchet sets a boolean variable bGETNEWBL to TRUE. The value of bGETNEWBL will determine whether new baselines are established upstream and downstream, with the initial definition of TRUE representing a standard assumption that a new administration set has been installed and that new baselines are required. According to the present invention, AntiRatchet tests this assumption by calculating the baseline delta value BL_DELTA, which results when the current readings of the pressure sensor UP_SAMPLE and DN_SAMPLE are considered the new baseline values, and comparing BL_DELTA to the delta of the minimum baseline BL_DELTA_MIN calculated by the OccBaselineDelta routine based on historical baseline data, as explained above in relation to Figure 11. The inventors recognized that a challenge to differentiate between an appropriate sensor baseline, taken at equilibrium, and an inadequate baseline, taken from a pressurized pipe, is the fact that, due to the variability of the management set, the baselines of different management sets can vary widely. However, the inventors have observed that the baseline delta BL_DELTA remains relatively stable for a given infusion pump, and does not vary significantly for different administration sets. For example, if a certain cassette is associated with a relatively high downstream baseline, the reading of the upstream baseline will also be relatively high. A different cassette may result in a vastly different level of the downstream baseline, but the upstream baseline will be affected in the same way, resulting in a similar baseline delta. In accordance with the present invention, the baseline delta BL_DELTA is used as a major factor in making a decision against continuous increase. Thus, BL_DELTA is defined as equal to UP_SAMPLE minus DN_SAMPLE in block 302, and decision block 304 verifies that this BL_DELTA is less than BL_DELTA_MIN.
    [0054] As will be understood, a BL_DELTA calculated in block 302 for a pressurized management set will be lower than an expected baseline delta for a new balanced management set (that is, if the set has an upstream obstruction) , UP_SAMPLE is decreased compared to an equilibrium reading, and if the set has an obstruction downstream, DN_SAMPLE is increased compared to an equilibrium reading). Consequently, if BL_DELTA is less than BL_DELTA_MIN in decision block 304, then bGETNEWBL is changed to FALSE in block 306, in order to maintain the current baselines. The decision against the continuous increase determining that the same administration set remains installed can be recorded in a record in block 308.
    [0055] If, however, decision block 304 finds that BL_DELTA is not less than BL_DELTA_MIN, it is likely that a new administration set has been installed. The limits in downstream baseline variability allow for another decision point for logic against continuous increase: if the downstream sensor DN_SAMPLE reading is greater than a certain level, it will always represent a pressurized signal, never a reading baseline in equilibrium. In the present example mode, if DN_SAMPLE exceeds 1,200 mV, it is assumed that the pipeline is pressurized. Decision block 310 makes this determination. If DN_SAMPLE exceeds 1,200 mV, then bGETNEWBL is changed to FALSE in block 312, in order to maintain the current baselines, and the decision against the continuous increase determining that the same management set remains installed can be recorded in a record in the block 313.
    [0056] Blocks 314 to 318, shown in Figure 10B, deal with baseline readjustment based on the value of bGETNEWBL verified in decision block 314. If bGETNEWBL is TRUE, then new baselines are established by adjusting of UP_THRESH and DN_THRESH as equal to zero in block 316. The event against the continuous increase, which determines that a new administration set has been installed, can be recorded in a record in block 318. If bGETNEWBL is FALSE, then blocks 316 and 318 are bypassed to maintain existing upstream and downstream baselines.
    [0057] The present invention is incorporated both in the form of a method and in the form of a pump apparatus programmed to carry out the method. An exemplary embodiment of the obstruction detection method and the pump apparatus of the present invention is described in detail in the present invention, but those skilled in the art will understand that modifications can be made without departing from the spirit and scope of the present invention, as defined the attached claims.
    权利要求:
    Claims (8)
    [0001]
    1. Method for detecting an obstruction in a pipe (4, 6, 8) connected to an infusion pump (10) by means of a cassette (5) received removably by the infusion pump, the infusion pump being it has a pumping mechanism (14, 20) that works to cause the fluid to flow through the tubing in a desired flow direction, a cassette access sensor (26) that provides a signal indicating whether there is access to the cassette to allow removal of the cassette and the installation of a new cassette, a sensor upstream (22) at a location along the pipeline upstream of the pumping mechanism, in the direction of flow, and a sensor downstream (24) in a location along the pipeline downstream of the pumping mechanism, in the flow direction, each of the upstream and downstream sensors providing a respective sensor signal, which indicates a respective local fluid pressure in the pipeline, the method comprising the steps of: establishing a line of b ase of the upstream sensor signal, corresponding to the fluid pressure balance at the upstream sensor site, and a baseline of the downstream sensor signal, corresponding to the fluid pressure balance at the downstream sensor site; characterized by the steps of: making a decision against continuous augmentation when there has been access to the cassette in response to a signal from the cassette access sensor, the decision against continuous augmentation determines whether or not the blocked pipeline has been replaced; maintain the baseline of the upstream sensor signal and the baseline of the downstream sensor signal established when the decision against continuous increase determines that the blocked pipeline has not been replaced; establish a new baseline of the upstream sensor signal and a new baseline of the downstream sensor signal when the decision against continuous increase determines that the blocked pipeline has been replaced; monitor a difference between the upstream sensor signal and the upstream sensor baseline signal to detect an obstruction in the pipeline upstream of the pumping mechanism; and monitoring a difference between the signal from the downstream sensor and the baseline signal from the downstream sensor to detect an obstruction in the piping downstream of the pumping mechanism.
    [0002]
    2. Method, according to claim 1, characterized by the fact that the step of making the decision against the continuous increase includes the sub-steps of calculating a baseline delta equal to a difference between the upstream sensor signal and the signal from the downstream sensor, and compare the baseline delta to a predetermined minimum baseline delta, and the decision against continuous increase determines that the blocked pipeline was not replaced if the baseline delta is less than the minimum baseline delta.
    [0003]
    3. Method, according to claim 1, characterized by the fact that the step of making the decision against the continuous increase includes the sub-step of comparing the downstream sensor signal to a predetermined downstream signal limit, being that the decision against continuous increase determines that the blocked pipeline has not been replaced if the signal from the downstream sensor is greater than the limit of the downstream signal.
    [0004]
    4. Method according to claim 2, characterized by the fact that the step of making the decision against continuous increase additionally includes the sub-step of comparing the downstream sensor signal to a predetermined downstream signal limit , and the decision against continuous increase determines that the blocked pipeline was not replaced if the signal from the downstream sensor is greater than the limit of the downstream signal.
    [0005]
    5. Method, according to claim 2, characterized by the fact that the minimum baseline delta is determined based on the historical baseline delta values stored by the infusion pump.
    [0006]
    6. Method according to claim 1, characterized in that it additionally comprises the step of displacing the baseline of the upstream sensor signal in correspondence with decreases in the upstream sensor signal that occur while the pumping mechanism is not in operation.
    [0007]
    7. Infusion pump (10) comprising: a cabinet (12) that includes a cassette receptacle (16), disposable to receive, in a removable manner, a cassette (5) to connect the tubing (4, 6, 8 ) the bomb; a pumping mechanism (14, 20) that works to cause the fluid to flow through the tubing in a desired flow direction; a cassette access sensor (26) that provides a signal indicating whether there is access to the cassette to allow removal of the cassette and installation of a new cassette; an upstream sensor (22) at a location along the pipeline upstream of the pumping mechanism, in the direction of flow, and a downstream sensor (24) at a location along the pipeline downstream of the pumping mechanism, in the direction of flow flow, each of the upstream and downstream sensors providing a respective sensor signal that indicates a respective local fluid pressure in the pipeline; one or more memory modules (38) configured to store a baseline of the upstream sensor signal, corresponding to the fluid pressure balance at the upstream sensor location, and a baseline of the downstream sensor signal, corresponding the balance of fluid pressure at the downstream sensor site; and a microprocessor (30) connected to one or more memory modules, the pumping mechanism, the cassette access sensor, the upstream sensor and the downstream sensor; characterized by the fact that the one or more memory modules comprises instructions that cause the microprocessor to make a decision against continuous augmentation based on a signal from the cassette access sensor, the decision against continuous augmentation determines whether the pipeline is obstructed has been replaced or not.
    [0008]
    8. Infusion pump, according to claim 7, characterized by the fact that the one or more memory modules is additionally configured to store instructions that cause the microprocessor to establish a new baseline of the sensor signal upstream and a new baseline of the downstream sensor signal when the decision against continuous increase determines that the blocked pipeline has been replaced.
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    法律状态:
    2018-12-04| B06F| Objections, documents and/or translations needed after an examination request according art. 34 industrial property law|
    2019-10-15| B06U| Preliminary requirement: requests with searches performed by other patent offices: suspension of the patent application procedure|
    2020-09-01| B07A| Technical examination (opinion): publication of technical examination (opinion)|
    2020-11-10| B09A| Decision: intention to grant|
    2020-12-29| B16A| Patent or certificate of addition of invention granted|Free format text: PRAZO DE VALIDADE: 20 (VINTE) ANOS CONTADOS A PARTIR DE 07/03/2013, OBSERVADAS AS CONDICOES LEGAIS. |
    优先权:
    申请号 | 申请日 | 专利标题
    US13/416,302|US9101712B2|2012-03-09|2012-03-09|Occlusion detection method|
    US13/416,302|2012-03-09|
    PCT/US2013/029475|WO2013134448A1|2012-03-09|2013-03-07|Occlusion detection method|
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