CN103727021B - Method for detecting at least one dysfunction in infusion assembly - Google Patents
Method for detecting at least one dysfunction in infusion assembly Download PDFInfo
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- CN103727021B CN103727021B CN201310681186.7A CN201310681186A CN103727021B CN 103727021 B CN103727021 B CN 103727021B CN 201310681186 A CN201310681186 A CN 201310681186A CN 103727021 B CN103727021 B CN 103727021B
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Abstract
The present invention relates to the method for detecting at least one dysfunction in infusion assembly, infusion assembly includes, and pumping equipment includes pump（1）, pumping equipment also includes：Pumping chamber with variable volume（11）, with the pumping chamber（11）Connect and include the entrance of a valve（2）, connected with the pumping chamber and include the outlet of a valve（5）, it is adapted to the actuator for changing the volume of the pumping chamber, fluid path, it includes the entrance（2）, the pumping chamber（11）, the outlet（5）With the downstream pipe positioned at the outlet valve downstream（7）, the pressure sensor of the pressure between the valve for measuring the path（4）, for handling from the pressure sensor（4）The processing unit of the pressure data received；This method is included in the pressure measured in pumping procedure in the fluid path, handles the pressure value finally obtained, and the pressure value based on the processing provides functional status.
Description
The application is that applicant is biotech company, and the applying date is on October 22nd, 2008, entitled " have and use
In dysfunction detection integrated pressure sensor Mems fluid " application for a patent for invention division Shen
Please.
Technical field
The present invention relates to medical pumping equipment, more specifically to the detection of the dysfunction of this equipment.
Background technology
The detection of dysfunction in the detection of dysfunction, particularly Medical Devices, it is important, because the life of patient
It may rely on the correct function of the equipment.For example, in the case of infusion pump, the result of failure potential danger is typically transfused
Medicine to patient is over or under.
The example of dysfunction is leakage, blocking or the presence of bubble in pump tubing length.
For detecting the state-of-the-art apparatus and method of dysfunction in Medical Devices for example in following patent document
Disclose：US2008/214979, EP1762263 and US7104763.
When using some drugses, such as insulin, the detection of blocking is probably especially important, because it is known that conduit can
It can block in many cases.Any this undetected block may all cause the conveying of insulin insufficient, because it grows
Phase is not detected.Current jam detection equipment is operated and needed before it is detected to the piston of syringe driver
High pressure is established inside syringe.Other blocking detectors are included in the upper pressure after pumping mechanism of patient's pipeline and passed
Sensor, due to the submissive sexual factor of such as conduit line, the pressure sensor does not almost have sensitivity.In some cases, exist
This shortage for blocking jam detection when starting causes high glucose plasma concentration, and this, which may be such that patient apparently likes, needs to increase
Its insulin level, cause the reprogramming of pump, this may cause, in the case where blocking releasing suddenly, to give suddenly relatively large
Insulin, potential grave danger is caused to patient.
The content of the invention
The invention provides a kind of standby selection on state-of-the-art apparatus and method and several improvement.
In the present invention, the detection of dysfunction is based in pump tubing length, more precisely the inlet valve of pumping chamber
In pump tubing length between outlet valve, the measurement of pressure.
This configuration provides the ability of the dysfunction of higher sensitivity and several potential types of detection.
More particularly it relates to such as the pumping equipment and related methods limited in claim.
According to a preferred embodiment of the invention, the entrance and exit of pumping equipment includes passive valve.
Advantageously, within the scope of the invention（But it is not limited to this）, consider the infusion pump of higher miniaturization.It is that have
The membrane pump and utilization MEMS technology of two passive valves are built.With being injected the pump of device driving on the contrary, micro-silicon pump, preferably
This micropump is built by silicon, illustrates more complicated fluid path and more accurately conveying control, although it is included with hard
The valve of seat, the valve with hard seat may be leaked potentially in the case where particulate be present.
Further preferably embodiment uses the pressure sensor for including silicon fiml to the present invention.
In another vantage of the invention, pressure sensor is placed between pumping chamber and outlet.The configuration provides
More accurately block control（Including detection blocks the ability started immediately during any pump cycles）Although also directed to other
Purpose, such as the detection of dysfunction.
According to another preferred embodiment of the present invention, system includes another pressure sensor.
Another pressure sensor preferably may be positioned at after outlet valve, in dirty pipeline.
In certain embodiments, system also includes temperature sensor.
The pressure sensor of the present invention can be several seconds in typically in the very short time in pump just at work, inspection
The dysfunction of several types is surveyed, such as blocking, bubble or extrusion infusing pipeline disconnect.
Another target of the present invention is the characteristic for showing pump exactly during the manufacturing cycle and/or the characteristic for monitoring pump
To prevent any incipient fault during use.
For manufacture for any Medical Devices, target is to ensure that the quality for being supplied to each pump of patient.For appointing
For what this medical product, the use of liquid is usually to detect the sole mode of failure of pump.Although this test needs long
Time and sizable cost is represented, but in the case of only changing whole fluid circuit after this test, it is
It is possible.In disposable products（Such as disposable pump）In the case of, it is impossible thus impossible to change fluid circuit
100% test of manufactured each this pump is ensured, because liquid pollution in test process be present.Thus only can be with
A collection of sample is operated, this test is destructive for the pump considered, and cannot ensure 100% quality control.
Present invention also offers a kind of system and a kind of method, its permission controls each pump produced without leading completely
Cause the pollution of this pump.This test is preferably performed with the air of filtration, and in the very short time of only several seconds
It is interior to produce all important parameters and the labor of security feature.Which can coexist with the cost objective of this disposable pump,
The disposable pump needs to be very cheap to manufacture.
Brief description of the drawings
The present invention will be more fully understood by describing in detail below, detailed description includes following example shown in the drawings：
Fig. 1 represents the cutaway view of the micropump of one embodiment of the present invention；
Fig. 2 and 3 represents the possibility process of the functional test of pump；
Fig. 4 represents another pressure curve of the functional test of dysfunction；
Fig. 5 typical pressure curves during the action cycle；
Fig. 6 represents the preferred embodiment of action cycle；
Fig. 7 represents the pump cycles of air and water；
Fig. 8 represents that the typical case of the outlet pressure curve when blocking be present develops；
Fig. 9 represents that the typical case of the inlet pressure curve when blocking be present develops；
Figure 10 represents to monitor the example of outlet pressure during blocking；
Figure 11 represents depositing the pressure curve of pump in the case of a leak；
Figure 12 represents to pump the monitoring of accuracy when flow reduction be present；
Figure 13 represents the sticky associated change for 1 DEG C of temperature change；
How Figure 14 is represented in figure using definition " crest " and " steady section ".
Embodiment
Micropump
Micropump 1 as shown in Figure 1 is higher miniaturization and shuttle barrier film pumping mechanism.It, which is utilized, is referred to as
MEMS（Microelectromechanical systems）Technology by silicon and glass manufacture.It includes in-let dimple element, is inlet valve 2 herein, pump
Send barrier film 3, it is allowed to the Function detection device 4 and outlet valve 5 of various failures in detecting system.The principle of this micropump is existing skill
It is known in art, such as from US5759014.
Fig. 1 shows pump, and it has the glassy layer as substrate 8（Blueness）, fixed to substrate 8 as the second plate 9
Silicon layer（Purple）With the second glassy layer 10 as top plate fixed to silicon plate 9（Blueness）Heap, so as to define with volume
Pumping chamber 11.
It is connected to the actuator of mesa 6（It is not shown here）So that pumping barrier film 3 carries out controlled displacement, also deposit
In groove 7 so as to by control of export element, outlet valve 5, the outlet being connected on the opposite side of pump.
Detector concept
In pump 1, the pressure in pumping chamber changes during pump cycles, and this depends on many factors, such as acts speed
Rate, the pressure of entrance and exit, bubble volume that may be present, valve characteristic and their slip.
According to the present invention, it is therefore an objective to monitor the pressure and analyze the curve from a stroke to another stroke to detect
Possible dysfunction.
Integrated pressure sensor
Pressure sensor 4 in micropump 1 is made up of the silicon fiml being placed between pumping chamber and pump discharge, and it is located at miniature
In the groove formed between the surface of pump silicon layer and the glassy layer at the top of it.In addition, it include it is a set of on the barrier film in favour this
The resistor of the strain sensitive of energization bridge configuration, it utilizes the huge piezoresistive effect of silicon.The change of pressure causes the change of barrier film
Shape, thus electric bridge not releveling.Sensor Design is into producing the letter linear with the pressure in the typical pressures range of pump
Number.
Fluid is in contact with the wire interconnected and the surface of piezoresistor.By using polarity and wire and pressure-sensitive
The opposite polarity other surface doping of resistor ensures the good electric insulation of electric bridge.
In another preferred embodiment of the present invention, pressure sensor includes optical sensor, and the sensor preferably includes
A part in pump path between two valves and at least some optical elements outside the fluid path, and
The pressure detected in fluid path can be measured.In another embodiment, optical detection can also be fully located in pump, simultaneously
The pressure between two valves in fluid path can be measured.In another embodiment, Optic Astigmation element is located in light path, that is, exists
Between flexible partition and optical sensor in pump.Any change of pressure all causes the displacement of the barrier film, the change of light path in pump
Change, thus due to the presence of astigmatic element, cause the change of beam shape.Such as by being passed including quadrant photodetector, light
Sensor is preferably to the shape sensitive of light beam.
Functional test
Can be for example in functional test of the manufacture aspect to the pump with the first process that pump performs according to the present invention.
Although using water known functional test continue several hours and must be regarded as it is destructive, according to this
The functional test of the pump of invention can only be completed in seconds using gas.Therefore, a people uses the small dead volume of pump
In the test and use above-mentioned integrated pressure sensor.
The principle of the functional test procedures is as follows：Overvoltage is produced in pump with actuator, technical staff is monitored in pumping chamber
Decline of pressure, it directly indicates slip.Maximum pressure is related to the compression ratio and its suction capacity of pump.Technical staff
Valve pretension can be obtained during the typical action cycle.
In order to for example can pneumatically control outlet valve in the indoor generation high pressure, technical staff, to press it
Remained turned-off in compression process, as shown in Figures 2 and 3.
More specifically, Fig. 2 and 3 represents the functional test of the pump according to the present invention（It is schematical process in Fig. 2, Fig. 3
In be corresponding pressure curve）.
In this test process, technical staff monitors the signal of detector, thus：
- pressure=0 indicates the resting position of barrier film
- pressure peak indicates the compression ratio of micropump
- decline of pressure indicates the slip of valve
Pressure in-step 3 indicates the pretension of outlet valve
Pressure in-step 4 indicates the pretension of inlet valve
As shown in the figure（Such as the continuous position seen in Fig. 2）, the test is since standby position.It is first carried out drawing step
Suddenly, the step by the motion of barrier film 3 from inlet valve 2 by gas " suction " interior.
Then perform and push away step so that the gas in room to be vented, while open outlet valve 5.In next step, then
Secondary closing outlet valve 5 and technical staff are performed using barrier film 3 draws again step, then technical staff in the next step
Outlet valve 5 is opened with the negative pressure in release room.
Finally, in the case where outlet valve 5 is closed, technical staff performs and pushes away step, and it corresponds to the compression using barrier film 3
Step.Room is now arranged under high pressure and decline of pressure（See Fig. 3）Indicate the slip of valve.
Due to caused high pressure and involved tiny volume, sensitivity in this way it is very high.
If technical staff is assumed in the initial manufacturing process of pump（For example, pass through MEMS technology）Due to suitable technique
Control, dead volume DV will not change too much, then can find directly related between compression ratio and swept volume SV.
Fig. 4 represents the pressure curve in the case of the failure of functional test.
In this case, the inlet valve of pump combines（Remain turned-off）And there is leakage.Pass through the drawing moving process in pump
In decline of pressure after caused huge negative pressure and each action, these problems related to inlet valve can be reduced.Surveying
The ending in cycle is tried, leakage is indicated in the decay of the ending of high compression step.
From before the first valve（For example, the end of reservoir）Medicament reservoir fluid lack situation
Under, particularly if using the closed soft reservoir of no passage, then it can also obtain identical during effect is pumped up
As a result.
On-line funchon abnormality detection
When as previously mentioned, in fluid operation, the pressure in pumping chamber not only directly depend on various functions and/or
External parameter, such as the pressure in entrance or exit, acting characteristic, and the characteristic of micropump is depended on, such as valve sealing,
Actual stroke volume or valve pretension.
Figure 5 illustrates the typical pressure curve during the action cycle using liquid.
Any change of the curve all indicates the dysfunction of pump or the pressure in entrance or exit increaseds or decreases
（It is for example, stifled after the negative pressure of liquid storage device due to bad ventilation, before inlet valve or overvoltage or outlet valve
Plug）.
Especially, the position of the steady section after the first pressure crest measured in pumping chamber directly indicates out
The pressure at pump discharge after mouth valve.After secondary peak, we have the direct of the pressure at inlet before inlet valve
Reading.The sealing of valve and/or the presence of bubble cause the amplitude of crest-crest and the change of peak width.In each ripple of pressure
Decline of pressure after peak analysis shows the slip of any of valve.
Figure 6 illustrates the position of the barrier film according to an embodiment of the invention during the normal operating period of pump
Move.
Embodiment according to this, moved by first half push of barrier film and start the cycle, half push is dynamic to be led
Cause pressure increase, outlet valve to open, thus cause liquid to be discharged.
The cycle is followed by completely drawing stroke to be full of pump（It is negative pressure wave during being full of of pump
Peak）, then release pumps barrier film, thus pumps barrier film and return to its resting position, causes second positive crest of pressure.
As described above, the differentiation for pumping room pressure directly depends on the acting characteristic of barrier film.
Such as, it is also possible to there is the cycle since complete stroke, the complete stroke results from roping complete first
Dynamic and subsequent complete push is moved.Such cycle is useful generally during the high speed operation of pump, such as is given in bolus
During medicine.In the case where acting like this, two crests can be only measured, are negative peak first, followed by positive wave
Peak.Analysis can dysfunction related to operation curve and causing same type detect.
Therefore, by using the pressure signal from the sensor between two valves, following features always can be
It is measured during pump cycles, and the direct sign of following characteristic can be caused：
1. immediately the positive crest of pressure（+）Steady section afterwards（+）Position depend on pre- of outlet valve
Power and the pressure at the pump discharge after outlet valve.
2. immediately the negative peak of pressure（-）Steady section afterwards（-）Position depend on pre- of inlet valve
Power and the pressure at the pump intake before inlet valve.
3. the sealing of valve, thus leak, it is related with the decay of time to pressure after each crest.
4. the relative position of two steady sections is also directly related with slip.
5. pressure crest（It is positive or negative）Height and width it is directly related with the presence of air in pump.
Priming charge and air detection
The priming charge of pump can also be monitored.Figure 7 illustrates the letter observed in the pumping procedure of air and water
Number marked difference.
As previously discussed, the crest of pressure may be changed due to the presence of air in pump.
Air detection can be verified in the following manner：
1. monitoring the height of pressure crest, it causes the possible alarm at given threshold value.
2. monitoring the width of pressure crest, it causes the possible alarm at given threshold value.
3. height was not only monitored but also had monitored width（Such as the differential for passing through signal）, it causes the determination of alarm threshold value.
Outlet pressure monitors
Fig. 8 shown in action process when pressure be present at the pump discharge after outlet valve, the typical case of pressure curve
Develop.
Inlet pressure monitors
Fig. 9 shows the figure same with Fig. 8, wherein the pressure with porch.
Therefore, in an action cycle, the accurate monitoring to inlet pressure and outlet pressure can be obtained.
Such as when medicament reservoir is the soft reservoir of no passage, this inlet pressure monitoring can also help to examine
Survey whether medicament reservoir empties.
Jam detection
Monitoring to outlet pressure can realize jam detection, as shown in Figure 10.
There is several methods that the curve that analysis reproduces in Fig. 10 during blocking.Technical staff for example can simply see
Examine the pressure change after each passage is dynamic.
Jam detection can be completed in the following manner：
1. monitor steady section（+）Position and determine alarm threshold value, typically in steady section（+）Position
It is changed into and crest（+）Initial height it is equal when.
2. utilize alarm threshold value monitoring crest（+）Height and width.
Due to measurement be in fluid path carry out and it is related to showing other measured values of other possible dysfunctions,
So the pressure measxurement in this pump causes very accurate and accurate jam detection.Thus, the measured value finally obtained can be with
To really block or pump outside flowing limitation it is related and can prevent notifying patient for inspection extrusion infusing pipeline or change note
Penetrate any delay during the demand of position.
Leak detection
Figure 11 shows the pressure curve of the pump of leakage.
After each action, pressure very rapidly discharges towards external pressure.In the case of no leakage, pressure
It will be discharged towards the valve pretension represented in terms of pressure.
Thus, the valve pretension prevents free-flowing, while also allows the detection method by the present invention to be leaked
Detection.
According to the mark provided in Figure 14, leak detection can be completed in the following manner：
1. monitor steady section（+）And steady section（-）Relative position and determine alarm threshold value.
2. the decline of pressure and the typical time constant of utilization after each pressure crest of monitoring determine alarm.
Such as on insulin closed-loop path apply pumping precision monitoring
Using the present invention, technical staff can detect the failure for the pumping precision that can be influenceed in accuracy specifications, such as valve is let out
Leakage or bubble.
Figure 12 shows the example of the detector signal for the pump for representing nominal travel volume, and identical pump is with particulate
In the case of detector signal example, wherein influenceing pumping precision in the case of with particulate up to 15%.It can pass through
Difference in height before and after analyzing big negative peak easily detects the leakage as caused by these particulates.
By the way that micropump is attached into blood glucose meter, this feature realizes closed-loop path application, because passing through detector
Realize the control of insulin delivery precision.
Detection is similar with leak detection herein, but is only focusing only on the leakage for influenceing precision.
1. monitor steady section（+）And steady section（-）Relative position and determine alarm threshold value, typically when they are immediately
In crest（+）With（-）When becoming equal after typical time constant afterwards.
2. the decline of pressure and the typical time constant of utilization after each pressure crest of monitoring determine alarm.
In the case of no this accurate monitoring to pump precision, any this closed-loop system all can be due to measurement
Parameter（It is the continuous monitoring to the glucose level for example in blood plasma or subcutaneous area or interstitial fluid in this example）And
Cause increasing or decreasing for the administration of such as insulin, the conveying change without considering pump.Most of all, in closed-loop path system
In the case of system, in order to ensure being fully understood by pumping parameter and it is controlled over time, so as to prevent appointing
What may Error Compensation related to pumping mechanism rather than with patient characteristicses correlation.Particularly, if with it is unknown defective
Pump or delivery device are related, and insulin Superfusion may cause to patient caused by the increase of glucose measurements
Harm.
When glucose measurements are the reflections of the glucose plasma level in delay in 10 to 30 minutes, the above situation
It is especially true.In this case, defective pump can cause the misinterpretation to patient's condition, and due to this mistake
Erroneous judgement is read, any change of pump operating condition（Such as the releasing of extrusion infusing pipeline blocking or the change of pumping performance）Will not by and
When detect so as to which harm to patient can not be prevented.
Detect the disconnection of extrusion infusing pipeline
In some cases, extrusion infusing pipeline may disconnect from pump, may hair between pump discharge and extrusion infusing pipeline connector
Raw leakage.If unauthorized extrusion infusing pipeline is connected to pump discharge by user, leakage also likely to be present.Let out due to this
Leakage, relatively low fluid resistance can be caused at pump discharge.When leakage becomes notable, by using integrated detection device or pass through
Second pressure sensor is placed on after being located at outlet valve in micropump, can detect a small amount of drop of the pressure at pump discharge
It is low.The sensitivity of the sensor should adapt to the pressure loss of extrusion infusing pipeline under normal condition.
The high instantaneous delivery of pump is very favorable caused by the principle of work and power of pump, because the pressure in extrusion infusing pipeline
Drop is directly proportional to flow.
If desired, preferably before patient is connected（Such as during the priming charge of pump）, can be set in pump
During, such as by producing one at a relatively high speed be used to discharge the stroke of liquid to carry out to the special of extrusion infusing pipeline sealing
Gate test.
Other pressure sensor at pump discharge
Primary detector is placed in pumping chamber.It is connected with reference to mouth with the air chamber in the housing of pumping system, as long as pumping system
Ventilation is good, and air chamber is at atmospheric pressure.The sensor is also relative pressure sensor.By the way that other pressure sensor is put
Put after outlet valve, the relative pressure sensor can be used for obtaining the information of the pressure on patient.
The other pressure sensor is directly related with the pressure of patient.Two pressure sensors, measurement pumping interior
The pressure sensor of pressure after the primary pressure sensor and measurement outlet valve of pressure should have identical to refer to mouth pressure.
Compare the differentiation of two signals after stroke in pump, at valve seat or between pump discharge and patient（Typically, patient's utensil
Bad connection）The detection of leakage be useful.This will further be more fully described in this declaratives.
In addition, after the stroke, i.e., when there is no during flow, the pressure differential between two sensors is also
The good instruction of mouth valve sealing.
The other sensor can be also used for detecting the abnormal pressure in exit, include the blocking of delivery device.
If desired, it can also be manufactured in the function of such as being carried out as described above using gas in this manual
The other sensor is calibrated during test.
By the second barrier film designed for pressure measxurement, the other pressure sensor is easily integrated to pump core
In piece：Can be as other pressure sensors in pump by being measured in Wheatstone bridge configuration using strain gauge
Pressure.It is desirable that the implantation dosage for strain gauge is equal with the implantation dosage of the primary detector in pump.Thus, if it is desired,
Technical staff can adjust sensitivity by simply changing the dosage of diaphragm size rather than themselves.
Preferably make the fluid path between the outlet valve of pump and patient's utensil during initial pump priming
Do not entrain into air.
Utilize the implementation for being used to preferably leak the temperature sensor monitored with precision of other pressure sensor
Reliability of this chapter discussion during the analysis of the second detector signal.
As it was previously stated, the width of pressure crest can be utilized and highly obtained on the downstream between pump and patient
The information of pipeline sealing.Technical staff can also propose the qualitative standard for these different characteristics.
In addition, for given fluid resistance, it is proportional to flow in the Integral Theory of pressure-time curve.The integration
Change be dysfunction good instruction, dysfunction not only includes bubble, leakage ..., and including temperature change.
P (t)-P (patient)=Rf × Q (t)
Wherein Rf is the fluid resistance between the other pressure sensor and patient, and Q (t) is instantaneous delivery, P (t)
It is the pressure measured by the other sensor.Consider laminar flow and Rf is provided by Poiseuille's law.P(patient)
It is the pressure of patient, and is also the pressure measured after flowing disappears by the other sensor.
The sensor is also the good indicator for pumping precision, because we directly can be become using flow over time
Change.Certainly, can be changed for the given pumping system including delivery device, fluid resistance by means of fluid viscosity with temperature
（Poiseuille's law）.It is desirable that the pressure sensor is also coupled to temperature sensor.
If using the liquid as water, viscosity is as the change of temperature is it is well known that signal can be carried out
Amendment to be no longer temperature dependent.Dysfunction detection even becomes more reliable now.
Temperature sensor can be placed in pump, such as be contacted with liquid, even if due to the small size of pump part and good
Thermal conductivity, this is not necessarily so really.
Heat sensor can be simple thermal resistance（RTD or resistance temperature detector）, it shows between 5 and 40 DEG C
Go out good sensitivity.The Wheatstone bridge of pressure sensor also show similar temperature dependency and can serve the mesh
, thermocouple can also be attached in pumping unit.Finally, can use cardinal temperature based on diode or transistor and
The semiconductor temperature sensor of current characteristics.
If two identical transistors are operated with different but constant Collector Current Densities, their emitter stage electricity
The difference and the PTAT of transistor of pressure.Then, the voltage difference is transformed into the voltage or electric current of single end.Can be with
Enter line displacement so that signal is transformed into Celsius temperature or Fahrenheit temperature from absolute temperature.
Figure 13 represents the sticky associated change for 1 DEG C of temperature change.Because fluid resistance is linear with viscosity
Ground changes, so directly become possibility using flow accuracy, can be expected the flow for 1 DEG C of temperature sensor resolution ratio
Precision：At 5 DEG C, the worst error as caused by temperature sensor is 2.8% on flow accuracy.Can also design sensor so as to
Introduce the error of the precision target less than flow.
The combination of the pressure sensor and temperature sensor in exit is used as cleverly relative pulsation flow sensor,
Due to the small response time of pressure sensor, so relative pulsation flow sensor is effective.
Absolute flow rate meter
Measured for absolute flows, it should which the fluid between other pressure sensor and patient is known with good precision
Resistance.Compared with the fluid resistance of the groove in micropump, patient's utensil typically shows fluid resistance from a collection of to another batch of
Great variety.Compared with the fluid resistance of the outlet slot in micropump, it is further noted that the fluid resistance of patient's utensil is kept
It is very low.
Compatible precision controlling fluid resistance Rf given above can be measured with absolute flows.
According to discussion above, if the fluid resistance of patient's utensil be kept as it is small, i.e. without the blocking of fluid circuit,
Then flow measurement is effective.
The flow in micropump exit is measured.In other pressure sensor（Connector ...）Any leakage below
The change of the signal shape of two detectors will be caused, but the flowing measured is still correct.
Flowing monitors and very strong feature, but we still need the information of two detectors for correctly explaining stream
Dynamic data.
In the calibration process of other pressure sensor, it is also possible to carry out the integration of the pressure signal proportional to flow
Calibration（The commercial flowmeter placed in series with pump discharge typically via utilizing）.Here it should be again noted that testing
Big fluid resistance is not introduced in journey in exit.
Certainly, the example that the present invention is not limited to be discussed above and shown, but the model of claim is included into covering
Enclose interior any embodiment.
Claims (21)
1. the method for detecting at least one dysfunction in infusion assembly, the infusion assembly include pumping equipment, institute
Stating pumping equipment includes pump (1), and the pumping equipment also includes：
- the pumping chamber (11) with variable volume,
- connected with the pumping chamber (11) and the entrance (2) including a valve,
- connected with the pumping chamber and the outlet (5) including a valve,
- it is adapted to the actuator that changes the volume of the pumping chamber,
- fluid path, it includes the entrance (2), the pumping chamber (11), the outlet (5) and the valve positioned at the outlet
The downstream pipe (7) in downstream,
The pressure sensor (4) of-pressure for being used to measure between the valve of the fluid path,
The processing unit of-the pressure data received for processing from the pressure sensor (4)；
This method is included in the pressure measured in pumping procedure in the fluid path, handles the pressure value finally obtained, and base
Functional status is provided in the pressure value of processing；
Wherein, this method is used for pumping equipment, and the pumping equipment realizes the repetition of pump cycles；Each pump cycles
Including at least one complete or partial sucting stage driven by the actuator, in the sucting stage phase completely or partially
Between, the volume increase of the pumping chamber, thus pressure reduces, and the pump cycles also include what is driven by the actuator
In at least one discharge stage completely or partially, during the discharge stage completely or partially, the volume of the pumping chamber reduces,
Thus pressure increase；In the ending of the pump cycles, pumping chamber's volume returns to its initial size；And
Wherein described pump cycles include two part stages separated by perfect state.
2. the method as described in claim 1, wherein after the discharge stage and/or after the sucting stage, often
The individual pump cycles also include at least one quiescent phase, and during the quiescent phase, the volume of the pumping chamber does not change,
Two valves are closed, thus the pressure in the pumping chamber is substantially constant but is different from the pressure in the entrance or the exit
Power.
3. the method as described in claim 1, wherein measuring dynamic pressure during each stage of pump cycles.
4. the method as described in claim 1, at least one in following dysfunction for detecting：Blocking, leakage, bubble,
Bad connection, pump the inaccurate, emptying of the failure of actuator, medicament reservoir.
5. the method as described in claim 1, wherein the processing of the pressure value finally obtained be included in the pressure value that measures that
Compared between this and/or between the pressure value measured and reference pressure value.
6. the method as described in claim 1, including pressure change, maximum are determined during at least one stage of pump cycles
It is at least one in pressure and/or minimum pressure.
7. the method as described in claim 1, including the time of predetermined pressure is realized in determination during pump cycles.
8. method as claimed in claim 2, for being detected during at least one quiescent phase by measuring pressure change rate
It is at least one in following dysfunction：Leakage, bad connection and pumping are inaccurate.
9. method as claimed in claim 8, wherein described static after in the discharge stage and the sucting stage
When the pressure value that at least two of stage measure becomes equal, leakage, bad connection and/or pumping are inaccurately examined
Survey.
10. the method as described in claim 1, for detecting downstream by measuring maximum pressure during the discharge stage
Block.
11. method as claimed in claim 2, if wherein pressure after the discharge stage during the quiescent phase
Force value does not reduce relative to the maximum pressure during the discharge stage, then detects blocking.
12. the method as described in claim 1, at least passing through during a discharge stage and/or a sucting stage
Pressure is measured to detect the air in the pumping equipment.
13. method as claimed in claim 12, if wherein in suction and pressure-responsive is shown substantially during the discharge stage
It is upper than the standardization low crest of pressure-responsive and/or wide crest, then detect the air in the pump.
14. the method as described in claim 1, including leak-testing, strengthen this by producing high pressure in the pumping chamber
Leak-testing.
15. method as claimed in claim 14, wherein after producing overvoltage in the pumping chamber, monitor the maximum of pressure
With decline of pressure with detect the slip of the pump, compression ratio and/or suction capacity, valve pretension, actuator failure and/or
Swept volume.
16. the method as described in claim 1, for measuring the pulsating flow of pumping equipment, methods described is using constant
Sampling interval measure pressure in the downstream pipe and pressure value that processing finally obtains.
17. the method as described in claim 1, for by utilizing pressure sensor and the downstream tube in the pump jointly
Pressure sensor in road is at least one in following parameters to detect：Flow velocity, block, leakage, bubble, bad connection, pumping
Inaccurately, the failure of the actuator.
18. method as claimed in claim 17, it is additionally operable to pressure sensor and the downstream tube that measurement is located in the pump
The slip of the valve between other pressure sensor in road, methods described include measure the outlet the valve downstream and
The pressure of upstream is simultaneously compared between the pressure value measured and/or is compared according to reference pressure value.
19. the method as any one of claim 2 to 10, if wherein described static after the discharge stage
Pressure value during stage does not reduce relative to the maximum pressure during the discharge stage, then detects blocking.
20. method as claimed in claim 14, wherein closing the valve of the outlet and by compressing by using external device (ED)
The volume stated in pumping chamber produces high pressure in the pumping chamber.
21. the method for at least one dysfunction for detecting infusion assembly, the infusion assembly include pumping equipment and defeated
Pipeline is noted, the pumping equipment includes pump (1), and the pumping equipment also includes：
- the pumping chamber (11) with variable volume,
- connected with the pumping chamber (11) and the entrance (2) including valve,
- connected with the pumping chamber and the outlet (5) including valve,
- it is adapted to the actuator that changes the volume of the pumping chamber,
- fluid path, it includes the entrance (2), the pumping chamber (11), the outlet (5) and the valve positioned at the outlet
The downstream pipe (7) in downstream,
The pressure sensor (4) of-pressure for being used to measure between the valve of the fluid path,
The processing unit of-the pressure data received for processing from the pressure sensor (4)；
This method includes measuring the pressure in the fluid path, handles the pressure value finally obtained, and the pressure based on processing
Value determines functional status；
This method also includes realizing by the repetition of the activation cycles of the pumping equipment, and each activation cycles are wrapped
Include：
- complete or partial the sucting stage driven by the actuator, the pumping chamber during the complete or partial sucting stage
It is filled,
- complete or partial discharge the stage driven by the actuator, the pumping chamber during the complete or partial discharge stage
It is drained, and
- wherein at least one activation cycles include two part stages separated by perfect state,
Wherein methods described is at least one in following parameters for detecting：Flow velocity, block, leakage, the state of priming charge, gas
Bubble, bad connection, pump accuracy, the failure of the actuator, the pretension of at least one valve, the compression of the pump
Than the disconnection of the extrusion infusing pipeline.
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 |
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| Publication Number | Publication Date |
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| CN103727021A CN103727021A (en) | 2014-04-16 |
| CN103727021B true CN103727021B (en) | 2018-01-23 |
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Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| EP3705148A1 (en) * | 2019-03-04 | 2020-09-09 | Avoset Health Ltd. | In cycle pressure measurement |
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| US11207465B2 (en) | 2015-06-04 | 2021-12-28 | West Pharma. Services Il. Ltd. | Cartridge insertion for drug delivery device |
| US20170049959A1 (en) | 2015-08-20 | 2017-02-23 | Sorrel Medical Ltd. | Automatic Catheter Recognition and Associated Methods, Systems and Circuits |
| US11185630B2 (en) * | 2016-04-12 | 2021-11-30 | Tatsuta Electric Wire & Cable Co., Ltd. | Liquid leakage detection device |
| US10011269B2 (en) * | 2016-11-30 | 2018-07-03 | Ford Global Technologies, Llc | Identifying in-range fuel pressure sensor error |
| US10471425B2 (en) * | 2017-02-16 | 2019-11-12 | International Business Machines Corporation | Automated machine for sorting of biological fluids |
| ES2871812T3 (en) * | 2017-03-16 | 2021-11-02 | Novartis Ag | Injector device |
| WO2019032375A1 (en) * | 2017-08-10 | 2019-02-14 | West Pharma, Services Il, Ltd. | Injector self-test and injector door unlocking mechanism responsive thereto |
| 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 |
| CN108894969B (en) * | 2018-07-05 | 2022-02-08 | 濮阳市百福瑞德石油科技有限公司 | Monitoring and judging method for drilling pump of petroleum drilling engineering and pumping pressure protection system thereof |
| 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 |
| US11890451B2 (en) | 2019-03-05 | 2024-02-06 | Eitan Medical Ltd. | Anti-free-flow valve |
| CN111089819B (en) * | 2019-12-17 | 2023-05-02 | 重庆南方数控设备股份有限公司 | Blood detection method for prejudging and detecting working state of pump based on hemorheology instrument |
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| DE102005058080A1 (en) * | 2005-12-06 | 2007-06-14 | Albert-Ludwigs-Universität Freiburg | Monitoring unit for micro pump, has fluid reservoir arranged between inlet valve and outlet valve, and including flexible reservoir diaphragm area, and strain measuring strip detecting volume and/or pressure in reservoir |
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| EP3705148A1 (en) * | 2019-03-04 | 2020-09-09 | Avoset Health Ltd. | In cycle pressure measurement |
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