CN103727021A - Method for detecting abnormality of at least one function of infusion assembly - Google Patents
Method for detecting abnormality of at least one function of infusion assembly Download PDFInfo
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- CN103727021A CN103727021A CN201310681186.7A CN201310681186A CN103727021A CN 103727021 A CN103727021 A CN 103727021A CN 201310681186 A CN201310681186 A CN 201310681186A CN 103727021 A CN103727021 A CN 103727021A
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Abstract
The invention relates to a method for detecting abnormality of at least one function of an infusion assembly. The infusion assembly comprises pumping equipment comprising a pump (1), wherein the pumping equipment further comprises a pumping chamber (11), an inlet (2), an outlet (5), an actuator, a fluid path, a pressure sensor (4) and a processing device, wherein the pumping chamber (11) has the variable volume, the inlet (2) is communicated with the pumping chamber (11) and comprises a valve, the outlet (5) is communicated with the pumping chamber and comprises a valve, the actuator is suitable for changing the volume of the pumping chamber, the fluid path comprises the inlet (2), the pumping chamber (11), the outlet (5) and a downstream pipeline (7) located on the downstream of the valve of the outlet, the pressure sensor (4) is used for measuring pressure between the path and the valves, and the processing device is used for processing pressure data received from the pressure sensor (4). The method comprises the steps that pressure in the fluid path is measured in a pumping process, a pressure value obtained finally is processed, and a function state is provided according to the processed pressure value.
Description
The application is that claimant is biotech company, and the applying date is on October 22nd, 2008, denomination of invention for " there is the Mems fluid of the integrated pressure sensor detecting for dysfunction " and the dividing an application of application for a patent for invention.
Technical field
The present invention relates to medical pumping equipment, relate to more precisely the parafunctional detection of this equipment.
Background technique
Parafunctional detection in parafunctional detection, particularly medical equipment, is important, because patient's life may rely on the correct function of this equipment.For example, the in the situation that of infusion pump, it is excessive or not enough that the result of fault potential risk is infused into patient's medicine typically.
Parafunctional example is the existence of leakage, obstruction or bubble in pumping pipeline.
For detection of parafunctional state-of-the-art equipment and method in medical equipment, for example in patent documentation below, disclose: US2008/214979, EP1762263 and US7104763.
When using some drugs, insulin for example, the detection of obstruction may be particular importance, because known catheters may be stopped up in many cases.Any this undetected obstruction all may cause the conveying of insulin not enough, because it is not detected for a long time.Current jam detection equipment operates the piston of syringe driver and need to before detecting it, in injector inside, set up high pressure.Other blocking detector is included in the upper pressure transducer after pumping mechanism of patient's pipeline, and due to the flexibility factor of for example pipeline pipeline, this pressure transducer does not almost have sensitivity.In some cases, when this obstruction starts, the shortage of jam detection causes high glucose PC, this may make patient it seems as if need to increase its insulin level, the reprogramming that causes pump, this may cause in the situation that stopping up releasing suddenly, give relatively large insulin, patient is caused to potential grave danger suddenly.
Summary of the invention
The invention provides a kind of standby selection and several improvement about state-of-the-art equipment and method.
In the present invention, parafunctional detection is based in pumping pipeline, more precisely, in the inlet valve of pumping chamber and the pumping pipeline between outlet valve, presses measurement of force.
The parafunctional ability that this configuration provides higher sensitivity and detected several potential types.
More specifically, the present invention relates to the pumping equipment and related methods as limited in claim.
According to a preferred embodiment of the invention, the entrance and exit of pumping equipment comprises passive valve.
Advantageously, (but being not limited to this) within the scope of the invention, considers the highly infusion pump of miniaturization.It is to have the diaphragm pump of two passive valve and utilize MEMS technology to build.Contrary with the pump that is injected device driving, micro-silicon pump, preferably this micropump is built by silicon, has shown more complicated fluid path and pipage control more accurately, although it comprises the valve with hard seat, with the valve of hard seat, in the situation that there is particulate, may leak potentially.
The present invention further preferably embodiment uses the pressure transducer that comprises silicon fiml.
In another vantage of the present invention, pressure transducer is placed between pumping chamber and outlet.This configuration provides to stop up more accurately controls (during being included in arbitrary pump cycles, detecting immediately the ability starting of stopping up), although also for other objects, as parafunctional detection.
According to another preferred embodiment of the present invention, system comprises another pressure transducer.
This another pressure transducer is arranged in dirty pipeline after preferably can being placed in outlet valve.
In certain embodiments, system also comprises temperature transducer.
Pressure transducer of the present invention can be when pump be worked, and general is in several seconds in the very short time, detects the dysfunction of several types, and for example obstruction, bubble or extrusion infusing pipeline disconnect.
Another target of the present invention is during the manufacturing cycle, to show exactly pump characteristics and/or monitor that pump characteristics is to prevent any incipient fault in using process.
For the manufacture of any medical equipment, target is to guarantee to offer the quality of each pump of patient.For any this medical product, the use of liquid is generally the sole mode of testing pump fault.Although time that this test need to be grown and represented sizable cost, the in the situation that of only changing whole fluid circuit after this test, it is only possible.For example, disposable products (disposable pump) in the situation that, it is impossible changing fluid circuit, thereby can not guarantee 100% test of each this pump of manufacturing, because there is liquid contamination in test process.Thereby only can operate a batch sample, this test is destructive for considered pump, and can not guarantee 100% quality control.
The present invention also provides a kind of system and a kind of method, and it allows to control each produced pump completely and the pollution that can not cause this pump.This test is preferably carried out with the air filtering, and within the very short time in several seconds only, produces the labor of all important parameters and security feature.Which can coexist with this disposable pump's cost objective, and described disposable pump need to manufacture dirt-cheap.
Accompanying drawing explanation
To understand better the present invention by describing in detail below, and describe in detail and comprise example shown in the drawings below:
Fig. 1 represents the cutaway view of the micropump of one embodiment of the present invention;
Fig. 2 and 3 represents the possible process of the FT function test of pump;
Fig. 4 represents another pressure diagram of the FT function test that presentation function is abnormal;
Fig. 5 is typical pressure diagram during the action cycle;
Fig. 6 represents the preferred embodiment of action cycle;
Fig. 7 represents the pump cycles of empty G&W;
Fig. 8 is illustrated in and exists the typical case of outlet pressure curve while stopping up to develop;
Fig. 9 is illustrated in and exists the typical case of inlet pressure curve while stopping up to develop;
Figure 10 is illustrated in the example that monitors outlet pressure in obstruction process;
Figure 11 is illustrated in the pressure diagram that has pump in the situation of leaking;
Figure 12 is illustrated in the supervision of pumping validity while existing flow to reduce;
Figure 13 represents the associated change for the viscosity of the temperature variation of 1 ℃;
Figure 14 represents how to use in the drawings definition " crest " and " steady section ".
Embodiment
micropump
Fig. 1 shows pump, its have as the glassy layer of substrate 8 (blueness), be fixed to substrate 8 conduct the second plate 9 silicon layer (purple) and to be fixed to the second glassy layer 10(as top board of silicon plate 9 blue) heap, thereby define the pumping chamber 11 with volume.
The actuator (not shown at this) that is connected to mesa 6 makes pumping barrier film 3 carry out controlled displacement, also has groove 7 so that by control of export element, and outlet valve 5, is connected to the outlet on the opposition side that is positioned at pump.
detector concept
In pump 1, the pressure in pumping chamber changes in pump cycles process, and this depends on many factors, as the pressure of speed of actions, entrance and exit, the bubble volume that may exist, valve characteristic and their leak-down rate.
According to the present invention, object is to monitor that this pressure the curve of analysis from a stroke to another stroke are to detect possible dysfunction.
integrated pressure sensor
Fluid contacts with the surface of interconnected wire and varistor.By utilizing the opposite polarity other surface doping of polarity and wire and varistor, guarantee that the good electrical of electric bridge insulate.
In another preferred embodiment of the present invention, pressure transducer comprises photoreceptor, this sensor preferably includes the part being included in two pump paths between valve and is positioned at least some optical elements outside this fluid path, and can measure the pressure detecting in fluid path.In another embodiment, optically detecting can also be positioned at pump completely, can measure the pressure between two valves in fluid path simultaneously.In another embodiment, Optic Astigmation element is positioned at light path, between the flexible partition and photoreceptor in pump.Any variation of pump internal pressure all causes the displacement of described barrier film, the variation of light path, thereby due to the existence of astigmatism element, causes the variation of beam shape.For example, by comprising quadrant photodetector, photoreceptor is the shape sensitive to light beam preferably.
fT function test
It according to the present invention, can be the FT function test to described pump in manufacture aspect for example by the first process that pump is carried out.
Although utilize the known FT function test of water to continue several hours and must be counted as destructively, the FT function test of pump in accordance with the present invention can utilize gas only in seconds to complete.For this reason, a people is used for the small dead volume of pump this test and uses above-mentioned integrated pressure sensor.
The principle of this functional test procedures is as follows: with actuator, in pump, produce overvoltage, technician monitors the decline of pressure in pumping chamber, and it has directly shown leak-down rate.Pressure maximum is relevant to compression ratio and the suction capacity thereof of pump.Technician also can obtain valve pretensioning during the typical action cycle.
For at described indoor generation high pressure, technician can for example pneumatically control outlet valve, to make it keep closing in compression process, as shown in Figures 2 and 3.
More particularly, Fig. 2 and 3 represents the FT function test (being schematic process in Fig. 2, is corresponding pressure diagram in Fig. 3) of pump in accordance with the present invention.
In this test process, technician monitors the signal of detector, thus:
-pressure=0 has shown the position of rest of barrier film
-pressure peak has shown the compression ratio of micropump
-decline of pressure has shown the leak-down rate of valve
Pressure gauge in-step 3 understands the pretensioning of outlet valve
Pressure gauge in-step 4 understands the pretensioning of inlet valve
(for example see the continuous position in Fig. 2) as shown in the figure, this test is from standby position.First carry out and draw step, this step is described indoor by gas " suction " from inlet valve 2 by the motion of barrier film 3.
Then carry out and push away step with by the gas emptying in chamber, open outlet valve 5 simultaneously.In Next step, again close outlet valve 5 and technician and utilize barrier film 3 execution to draw again step, then in next step, technician opens outlet valve 5 with the negative pressure in release room.
Finally, in the situation that outlet valve 5 cuts out, technician carries out and pushes away step, and it is corresponding to the compression step that utilizes barrier film 3.Chamber now under high pressure and decline of pressure (seeing Fig. 3) shown the leak-down rate of valve.
Due to produced high pressure and related small volume, so the sensitivity of the method is very high.
If technician supposition in the initial manufacture process of pump (for example, by MEMS technology) due to suitable technology controlling and process, dead volume DV can not change too much, can find directly related between compression ratio and swept volume SV.
Fig. 4 is illustrated in the pressure diagram in the situation of fault of FT function test.
In this case, the inlet valve of pump is in conjunction with (maintenance is closed) and have leakage.By pump draw moving process in decline of pressure after the huge negative pressure that produces and each action, can reduce these problems relevant to inlet valve.In the ending of test period, at the attenuation meter of the ending of high compression step, understand and leak.
In situation about lacking at for example, fluid from the medicament reservoir of (, the end of reservoir) before being positioned at the first valve, if particularly use the closed soft reservoir that there is no vent, also can between action period, obtain identical result pumping up.
online dysfunction detects
As previously mentioned, fluid-operated, when middle, the pressure in pumping chamber not only directly depends on various functions and/or external parameter, for example pressure in entrance or outlet port, acting characteristic, and depend on miniature pump characteristics, for example valve seal, actual stroke volume or valve pretensioning.
Figure 5 illustrates the typical pressure curve in utilizing the action cycle process of liquid.
Any variation of this curve has all shown that the dysfunction of pump or the pressure in entrance or outlet port increase or reduce (for example,, due to bad ventilation, the negative pressure that is positioned at inlet valve liquid storage device before or the obstruction after overvoltage or outlet valve).
Especially, immediately the position of the steady section after the first pressure crest of pumping Indoor measurement has directly shown the pressure at the pump discharge place after outlet valve.After secondary peak, we have the direct reading of the ingress pressure before inlet valve.The sealing of valve and/or the existence of bubble cause the amplitude of crest-crest and the variation of peak width.The leak-down rate of any in the clear valve of decline of pressure analytical table after each crest of pressure.
Figure 6 illustrates the displacement of barrier film according to an embodiment of the invention in the normal operating period process of pump.
According to the embodiment shown in this, by first of barrier film, partly push moving beginning the described cycle, this partly pushes and movingly causes that pressure increases, outlet valve is opened, thereby causes liquid to be discharged.
After the described cycle, be draw stroke completely in case make pump be full of (pump be full of process in be negative pressure crest), then discharge pumping barrier film, thereby pumping barrier film gets back to its position of rest, cause second positive crest of pressure.
As described above, the acting characteristic of barrier film is directly depended in the differentiation of pumping chamber's internal pressure.
For example, also may have the cycle starting from complete stroke, described complete stroke results from roping first completely and moves and push completely subsequently moving.Such cycle is useful conventionally in the high speed operation process of pump, for example, in bolus administration process.In the situation that moving like this, only can measure two crests, be first negative peak, be then positive crest.Analysis can be relevant to operation curve and causes the dysfunction of same type to detect.
Therefore,, by using the pressure signal from the sensor between two valves, following feature always can be measured in pump cycles process, and can cause the direct sign of characteristic below:
1. immediately following the position of the steady section (+) afterwards of the positive crest (+) at pressure, depend on that the pre-of outlet valve opens
The pressure at power and the pump discharge place after outlet valve.
2. immediately following the position of the steady section (-) afterwards of the negative peak (-) at pressure, depend on that the pre-of inlet valve opens
The pressure at power and the pump intake place before inlet valve.
3. the sealing of valve, thereby leakage is relevant to pressure decay in time after each crest.
4. the relative position of two steady sections is also directly related with leak-down rate.
5. the height of pressure crest (plus or minus) and width are directly related with existing of air in pump.
priming charge and air detection
Also can monitor pump priming.Figure 7 illustrates the marked difference of the signal of observing in the pumping procedure of empty G&W.
As previously discussed, the crest of pressure may be changed due to the existence of air in pump.
Air detection can be carried out verification by following manner:
1. monitor the height of pressure crest, it causes in the possible warning in given threshold value place.
2. monitor the width of pressure crest, it causes in the possible warning in given threshold value place.
3. not only monitored highly but also monitored width (for example, by the differential of signal), it causes determining of alarm threshold value.
outlet pressure monitors
In course of action when Fig. 8 shows pump discharge place after outlet valve and has pressure, the typical case of pressure diagram develops.
inlet pressure monitors
Fig. 9 shows the figure same with Fig. 8, wherein has the pressure of ingress.
Therefore,, in an action cycle, can obtain the accurate supervision to inlet pressure and outlet pressure.
For example, when medicament reservoir is while there is no the soft reservoir of vent, whether this inlet pressure monitors and also can help detection of drugs reservoir emptying.
jam detection
To the supervision of outlet pressure, can realize jam detection, as shown in Figure 10.
The curve that has several method analysis to reproduce in Figure 10 in obstruction process.Technician for example can observe simply at each pressure of passing after moving and change.
Jam detection can complete by following manner:
1. monitor the position of steady section (+) and determine alarm threshold value, typically in the position of steady section (+)
Become while equating with the initial height of crest (+).
2. utilize alarm threshold value to monitor height and the width of crest (+).
Due to measurement be in fluid path, carry out and parafunctional other measured values possible to showing other relevant, so the pressure measurement in this pump causes very accurately and jam detection accurately.Thereby the measured value finally obtaining can be relevant to real obstruction or the flow restriction outside pump and can prevents in any delay of notifying patient when checking extrusion infusing pipeline or changing the demand of injection position.
leak testtion
Figure 11 shows the pressure diagram of the pump of leakage.
After each action, pressure very rapidly discharges towards external pressure.In the situation that not leaking, the valve pretensioning that pressure represents the aspect towards from pressure discharges.
Thereby this valve pretensioning has prevented free-flow, also allow to carry out Leak testtion by detecting method of the present invention simultaneously.
According to the sign providing in Figure 14, Leak testtion can complete by following manner:
1. monitor the relative position of steady section (+) and steady section (-) and determine alarm threshold value.
2. monitor the decline of pressure after each pressure crest and utilize typical time constant to determine and report to the police.
the supervision of the pumping precision of for example applying about the closed-loop path of insulin
Utilize the present invention, technician can detect the fault of the pumping precision that can affect in accuracy specifications, and for example valve leaks or bubble.
Figure 12 shows the example of the detector signal of the pump that represents nominal travel volume, and the example of the detector signal of identical pump in the fine-grained situation of tool, wherein in the fine-grained situation of tool, affects pumping precision and reaches 15%.Can easily detect the leakage being caused by these particulates by height difference before analyzing large negative peak and afterwards.
By micropump is attached to blood glucose meter, this feature has realized closed-loop path application, and this is because realized the control of insulin delivery precision by detector.
Detection is similar at this and leak detection, but only concentrates on the leakage that affects precision.
1. monitor the relative position of steady section (+) and steady section (-) and determine alarm threshold value, typically after they are being next to crest (+) and (-) typical time constant afterwards, becoming while equating.
2. monitor the decline of pressure after each pressure crest and utilize typical time constant to determine and report to the police.
In the situation that there is no this accurate supervision to pump precision, any this closed-loop system all can cause increase or the minimizing of for example administration of insulin due to the parameter (being to for example continuous monitoring of the glucose level in blood plasma or subcutaneous area or interstitial fluid in this example) of measurement, and does not consider that the conveying of pump changes.The most important thing is, the in the situation that of closed-loop system, in order to ensure fully understanding pumping parameter and making it controlled along with the past of time, thus prevent any may be relevant to pumping mechanism but not relevant mistake compensates with patient characteristics.Particularly, if relevant to defective pump or the infusion utensil of the unknown, the excessive infusion of insulin causing due to the increase of glucose measurements may cause the harm to patient.
When glucose measurements is the reflection of the glucose plasma level in postponing for 10 to 30 minutes, above-mentioned situation is also real especially.Under these circumstances, defective pump can cause the misinterpretation to patient's condition, and due to this misinterpretation, any change of pump operating condition (releasing that for example extrusion infusing pipeline stops up or the change of pumping performance) thus will the harm that can not prevent patient can not detected in time.
detect the disconnection of extrusion infusing pipeline
In some cases, extrusion infusing pipeline may disconnect from pump, between pump discharge and extrusion infusing pipeline connector, may leak.If user is connected to pump discharge by unauthorized extrusion infusing pipeline, also may there is leakage.Due to this leakage, can cause lower fluid resistance at pump discharge place.When leakage becomes remarkable, by utilizing integrated form detector or by after the second pressure transducer is placed on is positioned at outlet valve in micropump, a small amount of reduction at pump discharge place pressure can being detected.The sensitivity of this sensor should adapt to the pressure loss of extrusion infusing pipeline under normal conditions.
The high instantaneous flow of the pump causing due to the principle of work and power of pump is very favorable because the pressure drop in extrusion infusing pipeline directly and flow proportional.
If needed, preferably, before connecting patient (for example, in pump priming process), in the process that can arrange at pump, for example, by producing at a relatively high speed one, for discharging the stroke of liquid, carry out the special test to extrusion infusing pipeline sealing.
other pressure transducer at pump discharge place
Primary detector is placed in pumping chamber.It is communicated with reference to the air chamber in the housing of mouth and pumping system, as long as pumping system ventilation is good, air chamber is just in barometric pressure.This sensor is also relative pressure sensor.After other pressure transducer is placed on to outlet valve, this relative pressure sensor can be used for obtaining the information about patient's pressure.
This other pressure transducer is directly related with patient's pressure.Two pressure transducers, measure the primary pressure sensor of the pressure in pumping chamber and the pressure transducer of the pressure after measurement outlet valve should have identical reference mouth pressure.Relatively the differentiation of two signals after stroke in pump, the detection of the leakage of (typically, the bad connection of patient's utensil) between valve seat place or pump discharge and patient is useful.This will further describe in more detail in these declaratives.
In addition, immediately, after described stroke,, when no longer including flow, the pressure difference between two sensors is also the good indication of outlet valve sealing.
This other sensor can also, for detection of the abnormal pressure in outlet port, comprise the obstruction of infusion utensil.
If need, can also calibrate this other sensor as described above in this manual during the function manufacturing test that utilizes gas to carry out.
By being designed for tonometric the second barrier film, this other pressure transducer can easily be integrated in pump chip: can be by carrying out measuring pressure in Wheatstone bridge configuration with resistance strain gauge as other pressure transducers in pump.Ideally, for the implantation dosage of resistance strain gauge, equate with the implantation dosage of primary detector in pump.Thereby if needed, technician can be by changing diaphragm size rather than their dosage regulates sensitivity simply.
Preferably make the fluid path between delivery side of pump valve and patient's utensil in the process of initial pump priming, not entrain into air.
utilize the enforcement for the temperature transducer that better leakage and precision monitor of other pressure transducer
This chapter discusses the reliability in the analytic process of the second detector signal.
As previously mentioned, can utilize the width of pressure crest and height to obtain the information about the downstream pipeline sealing between pump and patient.Technician also can propose the qualitative standard for these different characteristics.
In addition, for given fluid resistance, proportional with flow in the Integral Theory of pressure-time curve.The variation of this integration is parafunctional good indication, and dysfunction not only comprises bubble, leakage ..., and comprise temperature variation.
P(t)-P(patient)＝Rf×Q(t)
Wherein Rf is described other pressure transducer and the fluid resistance between patient, and Q (t) is instantaneous flow, and P (t) is by the pressure of described other sensor measurement.Consider laminar flow and provide Rf by Poiseuille's law.P (patient) is patient's pressure, and is also by the pressure of described other sensor measurement after the disappearance of flowing.
This sensor is also the good indicator of pumping precision, because we can directly utilize the changes in flow rate along with the time.Certainly, for the given pumping system that comprises infusion utensil, fluid resistance can be by means of fluid viscosity along with temperature change (Poiseuille's law).Ideally, this pressure transducer is also coupled to temperature transducer.
If use the liquid resemble water, viscosity, along with the variation of temperature is well-known, can be carried out the correction of signal to be no longer temperature dependent.Dysfunction detects and even becomes now more reliable.
Temperature transducer can be placed in pump, for example, contact with liquid, even due to the small size of pump parts and good thermal conductivity, be not to do so really.
Thermosensor can be simple thermal resistor (RTD or resistance temperature detector), and it demonstrates good sensitivity between 5 and 40 ℃.The Wheatstone bridge of pressure transducer has also shown similar temperature dependency and can serve this object, also thermocouple junction can be incorporated in pumping unit.Finally, can use the semiconductor temperature sensor based on diode or transistorized cardinal temperature and current characteristics.
If two identical transistors are with different but constant Collector Current Density operations, the difference of their emitter voltage and transistorized kelvin temperature are proportional.Then, this voltage difference is transformed into voltage or the electric current of single end.Can be offset that signal is transformed into degree centigrade or Fahrenheit temperature from kelvin temperature.
Figure 13 represents the associated change for the viscosity of the temperature variation of 1 ℃.Because fluid resistance changes linearly along with viscosity, so directly utilize the flow accuracy possibility that becomes, can expect this flow accuracy for the temperature transducer resolution of 1 ℃: at 5 ℃, the maximum error being caused by temperature transducer is 2.8% on flow accuracy.Also sensor can be designed to introduce the error lower than the precision target of flow.
The pressure transducer in outlet port can be used as relative Pulsating Flow sensor cleverly with the combination of temperature transducer, due to the little response time of pressure transducer, so Pulsating Flow sensor is effective relatively.
absolute flow rate meter
For absolute flows, measure, should know other pressure transducer and the fluid resistance between patient with good precision.Compare with the fluid resistance of groove in micropump, patient's utensil typically shows the great variety of fluid resistance from a collection of to another batch.Compare with the fluid resistance of outlet slot in micropump, be further noted that very low that the fluid resistance of patient's utensil is kept.
Can control the fluid resistance Rf providing above with measuring compatible precision with absolute flows.
According to discussion above, as long as the fluid resistance of patient's utensil keeps littlely, that is, there is no the obstruction of fluid circuit, flow measurement is effective.
The flow in micropump outlet port is measured.At other pressure transducer (connector ...) any leakage below will cause the variation of the signal shape of two detectors, but the mobile of measurement remains correct.
Mobile supervision is also very strong feature, but we still need the information of two detectors for the correct flow-data of explaining.
In the calibration process of other pressure transducer, also may carry out the calibration (typically by utilizing the commercial flowmeter of in series placing with pump discharge) to the integration of the proportional pressure signal of flow.Here should again note in outlet port, not introducing large fluid resistance in test process.
Certainly, the present invention is not limited to the example of discussing and illustrating in the above, but covers any embodiment in the scope that is included into claim.
Claims (19)
1. for detection of at least one the parafunctional method in infusion assembly, described infusion assembly comprises pumping equipment, and described pumping equipment comprises pump (1), and described pumping equipment also comprises:
-there is the pumping chamber (11) of variable volume,
-be communicated with and comprise the entrance (2) of a valve with described pumping chamber (11),
-be communicated with and comprise the outlet (5) of a valve with described pumping chamber,
-applicable the actuator that changes the volume of described pumping chamber,
-fluid path, the downstream pipeline (7) that it comprises described entrance (2), described pumping chamber (11), described outlet (5) and is positioned at outlet valve downstream,
-for measuring the pressure transducer (4) of the pressure between the described valve in described path,
-for the treatment of the treatment device of the pressure data of receiving from described pressure transducer (4);
The method is included in pumping procedure and measures the pressure in described fluid path, process the force value finally obtaining, and the force value based on described processing provides functional status.
2. the method for claim 1, for pumping mechanism, described pumping mechanism by pump cycles repeat realize; Described in each, pump cycles comprises at least one sucting stage, and during described sucting stage, the volume of described pumping chamber increases, thereby pressure reduces, and also comprise at least one discharge stage, during the described discharge stage, the volume of described chamber reduces, thereby pressure increases; In the ending in described cycle, described pumping chamber volume turns back to its initial size.
3. method as claimed in claim 2, wherein after the described discharge stage and/or after described sucting stage, described in each, pump cycles also comprises at least one quiescent phase, during this quiescent phase, the volume of described pumping chamber does not change, two valves are closed, thereby the pressure in described pumping chamber is substantially constant but be different from the pressure in described entrance or described outlet port.
4. the method as described in any in aforementioned claims 1 to 3 is wherein measured dynamic pressure during each stage of pump cycles.
5. the method as described in any in aforementioned claim 1 to 4, for detection of at least one in following dysfunction: the fault of obstruction, leakage, bubble, bad connection, pumping inaccuracy, actuator, medicament reservoir emptying.
6. the method as described in any in aforementioned claim 1 to 5, the force value measuring described in the processing of the force value wherein finally obtaining is included in compares each other and/or between reference pressure value.
7. the method as described in any in aforementioned claim 1 to 6, determines at least one in pressure variation, pressure maximum and/or pressure minimum during being included at least one stage of pump cycles.
8. the method as described in any in aforementioned claim 1 to 7, determines the time of realizing predetermined pressure during being included in pump cycles.
9. the method as described in any in aforementioned claim 3 to 8, for detecting at least one of following dysfunction: leak, bad connection and pumping inaccuracy during at least one quiescent phase by measuring pressure variance ratio.
10. the method as described in last claim, wherein, when at least two force value that measure of the described quiescent phase after described discharge stage and described sucting stage become equal, detects leakage, bad connection and/or pumping inaccuracy.
11. methods as described in any in aforementioned claim 1 to 10, for detecting downstream and stop up by measuring pressure maximum during the described discharge stage.
12. methods as described in any in aforementioned claim 3 to 11, if wherein after the described discharge stage, the pressure maximum during the force value during described quiescent phase is with respect to the discharge stage does not reduce, at least do not reduce a certain percentage or value, obstruction detected.
13. methods as described in any in aforementioned claim 1 to 12, at least detecting the air of described pumping unit during a discharge stage and/or a sucting stage by measuring pressure.
14. methods as claimed in claim 13, if wherein during compression and/or the cycle of finding time pressure response shown substantially than the low crest of standardization pressure response and/or wide crest, the air in described pump detected.
15. methods as described in any in aforementioned claim 1 to 14, comprise leak-testing, by produce high pressure in described pumping chamber, strengthen leak-testing, wherein for example by closing described outlet valve with external means and producing described high pressure by the volume compressing in described pumping chamber.
16. methods as described in last claim, after wherein producing overvoltage in described pumping chamber, monitor that the maximum value of pressure and decline of pressure are to detect leak-down rate, compression ratio and/or suction capacity, the valve pretensioning of described pump, fault and/or the swept volume of actuator.
17. methods as described in any in aforementioned claim 1 to 16, for measuring the pulsating flow of pumping equipment, described method comprises utilizes the constant sampling interval measure the pressure in the pipeline of described downstream and process the force value finally obtaining.
18. methods as described in any in aforementioned claim 1 to 17, be used for by jointly utilizing the pressure transducer of described pump and the pressure transducer in the pipeline of described downstream to detect at least one in following parameters: flow velocity, stop up, leak, bubble, bad connection, pumping inaccuracy, the fault of described actuator.
19. methods as described in last claim, also, for measuring the leak-down rate at pressure transducer and the valve between the other pressure transducer in the pipeline of described downstream of described pump, described method comprises to be measured the pressure of described outlet valve downstream and upstream and compares each other and/or compare according to reference pressure value in the described force value measuring.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201310681186.7A CN103727021B (en) | 2008-10-22 | 2008-10-22 | Method for detecting at least one dysfunction in infusion assembly |
Applications Claiming Priority (2)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201310681186.7A CN103727021B (en) | 2008-10-22 | 2008-10-22 | Method for detecting at least one dysfunction in infusion assembly |
| CN200880130983.3A CN102143775B (en) | 2008-10-22 | 2008-10-22 | There is the Mems fluid of the integrated pressure sensor for dysfunction detection |
Related Parent Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CN200880130983.3A Division CN102143775B (en) | 2008-10-22 | 2008-10-22 | There is the Mems fluid of the integrated pressure sensor for dysfunction detection |
Publications (2)
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| CN104606738A (en) * | 2015-01-28 | 2015-05-13 | 深圳市科曼医疗设备有限公司 | Signal detection method and device for injection pump |
| CN108120551A (en) * | 2016-11-30 | 2018-06-05 | 福特环球技术公司 | Identification range fuel pressure transducer errors |
| CN108302017A (en) * | 2018-03-19 | 2018-07-20 | 苏州原位芯片科技有限责任公司 | A kind of Diaphragm pump system and its detection method |
| CN108894969A (en) * | 2018-07-05 | 2018-11-27 | 濮阳市百福瑞德石油科技有限公司 | Petroleum drilling engineering drilling pump suppresses the monitoring judgment method and its pump pressure guard system of pump |
| CN109026653A (en) * | 2018-09-29 | 2018-12-18 | 瞬知（广州）健康科技有限公司 | A kind of infusion abnormal state detection and control system based on micro-fluidic pump |
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| CN110248735A (en) * | 2017-02-16 | 2019-09-17 | 国际商业机器公司 | For sorting the automatic machinery of biofluid |
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| TWI679064B (en) * | 2014-10-23 | 2019-12-11 | 日商東京威力科創股份有限公司 | Liquid delivery method, liquid delivery system, and computer-readable storage medium |
| CN111089819A (en) * | 2019-12-17 | 2020-05-01 | 重庆南方数控设备股份有限公司 | Blood detection method for pump working state pre-judgment detection based on hemorheometer |
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| US11033681B2 (en) | 2015-08-20 | 2021-06-15 | Q-Core Medical Ltd. | Automatic catheter recognition and associated methods, systems and circuits |
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| US11033681B2 (en) | 2015-08-20 | 2021-06-15 | Q-Core Medical Ltd. | Automatic catheter recognition and associated methods, systems and circuits |
| CN109069741A (en) * | 2016-04-12 | 2018-12-21 | 拓自达电线株式会社 | Apparatus for testing weeping |
| CN108120551A (en) * | 2016-11-30 | 2018-06-05 | 福特环球技术公司 | Identification range fuel pressure transducer errors |
| CN108120551B (en) * | 2016-11-30 | 2021-07-06 | 福特环球技术公司 | Identifying fuel pressure sensor errors within range |
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| CN111163818A (en) * | 2017-08-10 | 2020-05-15 | 西部制药服务有限公司(以色列) | Syringe door unlocking mechanism with self-test and response of syringe |
| CN111163818B (en) * | 2017-08-10 | 2021-05-14 | 西部制药服务有限公司(以色列) | Syringe door unlocking mechanism with self-test and response of syringe |
| US11857767B2 (en) | 2017-12-22 | 2024-01-02 | West Pharma. Services IL, Ltd. | Injector usable with different dimension cartridges |
| CN108302017B (en) * | 2018-03-19 | 2023-10-10 | 苏州原位芯片科技有限责任公司 | Diaphragm pump system and detection method thereof |
| CN108302017A (en) * | 2018-03-19 | 2018-07-20 | 苏州原位芯片科技有限责任公司 | A kind of Diaphragm pump system and its detection method |
| CN108894969A (en) * | 2018-07-05 | 2018-11-27 | 濮阳市百福瑞德石油科技有限公司 | Petroleum drilling engineering drilling pump suppresses the monitoring judgment method and its pump pressure guard system of pump |
| CN109026653A (en) * | 2018-09-29 | 2018-12-18 | 瞬知（广州）健康科技有限公司 | A kind of infusion abnormal state detection and control system based on micro-fluidic pump |
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| US11890451B2 (en) | 2019-03-05 | 2024-02-06 | Eitan Medical Ltd. | Anti-free-flow valve |
| CN111089819A (en) * | 2019-12-17 | 2020-05-01 | 重庆南方数控设备股份有限公司 | Blood detection method for pump working state pre-judgment detection based on hemorheometer |
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