This application is the U.S. national phase of International Application No. PCT/IB2011/055771, filed 19 Dec. 2011, which designated the U.S. and claims priority to EP Application No. 10196809.7, filed 23 Dec. 2010, the entire contents of each of which are hereby incorporated by reference.
The present invention concerns an electronic control system and a smart process to optimise the power consumption of a micropump (for example a piezoelectric micropump) and to verify the reliability of the pumping mechanism in functioning, typically by analysing the signals of two integrated detectors as a function of the actuator voltage.
Lifetime of the batteries is one of the most sensitive limitations for portable medical devices like insulin pumps and other similar devices. It is defined as the ratio between battery capacity and power consumption. Considering a defined battery, its lifetime can only be increased by reducing the power consumption of the device powered by said battery.
In most membrane pumps, the pumping membrane is over-actuated against precise mechanical stops, in order to have an excellent repeatability and a pumping precision by controlling the stroke volume (see for example EP 0 737 273).
In the particular case of a piezoelectric actuator, the maximum voltage is set to compensate misalignments of the actuator and also to ensure the pumped volume does not depend on environmental conditions. Despite all the variations and uncertainties related to tolerances, the actuated membrane should always reach the same amplitude. However, it is clear that the larger the safety margin, the larger the voltage applied, and therefore the larger the power consumption.
The patent application WO 03/023226 A1 (applicant: Medtronic Minimed Inc.) presents an electronic control systems and process for infusion devices and pump configurations that can provide a highly efficient use of electrical power.
In this prior art, the system may include a capacitor, which is controlled to partially, but not fully discharge, to provide a power pulse to a pump coil. A power cut-off switch may be provided to control the discharge of the capacitor such that the capacitor is stopped from discharging prior to the actual end of the armature stroke. The time at which the capacitor discharge is stopped may be selected such that energy remaining in the coil after the capacitor stops discharging is sufficient to continue the pump stroke to the actual end of the stroke. A power disconnect switch may be provided between the capacitor and the battery, to allow the capacitor to be electrically disconnected from the battery during storage or other periods of non-use.
Document US 2009/0140185 discloses a system and method to improve and optimize the flow rate accuracy of a fluidic delivery system, for example an implantable drug infusion delivery system, whereby the desired flow rate is achieved by varying the duty cycle of the valve. The disclosed valve assembly comprises a piston that is actuated by a piezoelectric actuator, the movement of the piston allowing fluid (e.g. a drug in liquid form) supplied to an inlet passage moving past piston via a groove to enter a collection space at the other end of the piston and then, from there, to be forced into an outlet passage and eventually directed to site of interest, such as a desired treatment area of a patient. The downward movement of the piston is controlled by applying a specific electric signal to the piezoelectric actuator which as a result deforms with a slight downward displacement.
A desired constant flow rate of fluid delivered can be defined by varying the duty cycle, i.e. the ratio of valve opened time to the valve closed time.
Other prior art publications relating to similar pumps are for example U.S. Pat. No. 5,759,015, WO 01/90577, EP 1 839 695 and EP 2 059 283 and WO 2010/046728 all incorporated by reference in the present application as regards the construction of such pumps.
EP application No. 09178168.2 filed on Dec. 7, 2009 by the same Applicant as the present application discloses a flexible element for micro-pump which may be actuated by a piezoelectric element. This earlier application is incorporated in its entirety in the present application as regards the description of micro-pumps actuated by a piezoelectric element.
Considering piezoelectric actuated reciprocating membrane pump including a sensor, as for example disclosed in EP 09178168.2 mentioned here above, the present invention provides an improved method and control system able to minimize the driving voltage of an actuator based on the measurements of at least one embedded sensor, in order make the pumping membrane of a medical device reach a defined position, with the following targets:
Preferably, the defined position corresponds to one or more mechanical stops that limit the stroke of the pumping membrane.
Preferably, the actuator is a piezoelectric actuator.
Preferably, the optimum voltage is reached through a learning process.
Preferably, the learning process necessary to determine this optimal actuation voltage is done during the first pumping stroke but can be also performed:
Preferably, one of the sensor used is:
Of course, the preferred embodiments mentioned above are only possible examples of realization and should not be construed in a limiting manner.
The present invention and its embodiments will be better understood from the following detailed description and drawings of illustrative embodiments of the invention, in which
Description of the Pump
In order to clearly define the innovation, we will describe the different element composing the pump system (typically for example as disclosed in EP 09178168.2 incorporated in its entirety in the present application) by reference to
Such highly miniaturized and reciprocating membrane pumping mechanisms are preferably made in silicon using MEMS techniques according to the prior art cited here above. In such preferred embodiment, the micro-pump (101) as illustrated in
An actuator (not represented here) linked to the mesa (106) allows the controlled displacement of the pumping membrane (103). The pumping membrane (103) displacement is limited, in the upward direction, by the plate (110) which corresponds to the mechanical stop (2) of the
The inlet (3, 102) of the pumping mechanism is connected to a liquid reservoir that should comprise a filter while the outlet (5, 105) is connected to a patient via a fluidic pathway that should comprise valves or flow restrictors, pressure sensor, air sensor, flowmeter, filter, vent, septum, skin patch, needles and any other accessories.
The Sensor (104) measures defined characteristics of the pump stroke. These characteristics can be the pressure at one or multiple points of the system, as integrated in known pump design (see publication WO 2010/046728) but can be, for example:
In one embodiment, the sensor (104) is preferably a pressure sensor placed within the pumping chamber cavity (111) and between the inlet chamber (102) and the outlet chamber (105). These inlet (102) and outlet (105) can be valves preferably passive, or flow restrictors. For MEMS micropumps, the pressure sensor (104) could be made of a silicon flexible membrane comprising a set of strain sensitive resistors in a Wheatstone bridge configuration, making use of the huge piezo-resistive effect of the silicon. A change of pressure induces a distortion of the membrane and therefore the bridge is no longer in equilibrium. The sensor (104) is designed to make the signal linear with the pressure within the typical pressure range of the micropump (101). The sensor backside can be vented for differential pressure measurement or sealed under vacuum for absolute pressure measurements. The membrane of the sensor (104) is preferably circular or square shaped. Depending on the micropump structure, the strain gauges and the interconnection leads may be implanted on the sensor surface which is intended to be in contact with the pumped liquid. To ensure a good electrical insulation of the sensor (104), a protective and insulating layer shall be used. Alternatively, an additional sensor surface doping of polarity opposite to that of the leads and the piezo-resistors could be used to prevent current leakage.
The very low compressibility of the silicon micropump (101) coupled to the small pumping cavity volume (111) (few hundreds of nanoliters) and the high compression ratio (up to 2 or more) make the pressure sensor placed within the pumping cavity (111) very sensitive to change of pressure as low as 1 mbar. This sensor (104) is suitable to detect very small change of the pumping membrane (103) position (fractions of microns) during the actuation phases as described hereafter. More details on the integrated pressure sensor (104) capabilities are given in the document WO2010046728.
At a higher level, the control system of the pump is composed of the following elements, as represented on
An idea of the present invention is to determine the minimal actuation voltage that, should be applied to the piezoelectric actuator to ensure the pumping membrane (1) reaches the mechanical stop(s) (2). After contact, the mechanical stop(s) (2) is (are) pushed ideally with a force equal to zero, or with a minimal force only high enough to withstand a pressure exerted on the membrane (1). Hereafter, this minimum voltage is referred to as the optimal voltage and labelled VAct Optimal.
This behaviour illustrated by
More specifically, the two figures on the first line (left and right column) illustrate the idle state where the applied voltage is equal to zero (V=0). The piezoelectric actuator (6) does not move and the membrane (1) is not displaced. The fluidic pathway is therefore “open”.
On the second line, the illustrated behaviour is the one where the optimal actuation voltage is used, i.e. where the displacement “d” of the piezoelectric actuator corresponds exactly to the necessary distance for the membrane (1) to reach the desired mechanical stop (2), i.e. the distance “d”. This is the behaviour one tries to reach in the present invention. As illustrated in the right column, the free displacement of the actuator also corresponds to the distance “d”.
On the third line, an over-actuation behaviour (and voltage) is illustrated. In this configuration, the voltage used is higher than the optimum value so that the displacement of the actuator (6) is over the distance “d” (as illustrated in the drawing of the right column). In this case, energy is lost because the system has a mechanical stop that will block the movement of the actuator and the membrane (1) would have reached this mechanical stop using a lower voltage, for example the optimal actuation voltage.
It is therefore an aim to be able to determine the optimal actuation voltage that is necessary for the device to function properly as illustrated in the second line of
Objectives of Using VAct Optimal
There are mainly three objectives in the present invention, which will be detailed hereafter:
This invention allows the reduction of power consumption in a system that uses piezoelectric actuators by applying the lowest voltage necessary. The energy required for the actuation of the piezoelectric actuator can be calculated using the capacitor equivalent model:
EPiezo=½CV2
Where C is the piezoelectric actuator capacity and V the voltage applied. This formula demonstrates that a 50% voltage reduction decrease the energy by a factor of 4, a 29.3% voltage reduction leads to a factor of 2.
This invention is also powerful to determine the reliability of the actuator during pumping.
For example, the assembly of a piezoelectric actuator (6) includes a mechanical loop made of: a substrate, a pump, an actuator and a flexible link between the pumping membrane (1) and this actuator (6) (See the application EP09178168.2). These different elements are typically glued together. During the normal use of the pump, these glues undergo high stresses which can lead to a failure of this mechanical loop and thus of the pump itself. A typical failure is the delamination of the piezoelectric actuator (6). This delamination is progressive and often very difficult to observe before the complete failure: the overdriving of the piezoelectric actuator (6) compensates at least at the beginning the delamination of the actuator (6). For portable drug infusion system, a method that can help to identify the beginning of the failure is desirable.
In one embodiment described below, the learning phase comprises the recording first of the nominal values of the pressure sensors at the maximum voltage. Then the voltage is decreased and the signals are monitored up to a significant change in the detector signals, indicating the mechanical stops (2) are not reached.
We assume first that the mechanical loop is functional before the first start of the pump. During the priming of the pump the learning phase can be achieved. It is important to note that a second pressure sensor located after the chamber outlet can be used as a flowmeter since the integral of its signal is proportional, for a given temperature, to the flow rate. Therefore we assume that the nominal signal of the second detector at the maximum voltage Vmax is representative of the nominal stroke volume of the pump, i.e. when the two mechanical stops are reached by the pumping membrane during the actuation.
By reducing step by step the actuation voltage and by monitoring the signal of the pressure sensor (104), it is possible to detect a minimum (and thus optimal) voltage VAct Optimal necessary to reach the nominal stroke volume.
It is obvious that this VAct Optimal depends on the reliability of the mechanical loop, any delaminating will increases the value of VAct Optimal. This method is very sensitive and reliable because the overdriving of the piezoelectric actuator (6) is bypassed and also because we have a direct access to the stroke volume, which is the more relevant value in terms of safety and reliability.
In practice, a functional reliability test consists of the checking of the pressure signals amplitude by using an actuation voltage slightly larger than VAct Optimal.
The first pressure sensor (104) located within the pumping chamber (4, 111) should also be used for this process.
It is also important to note that the rest position of the membrane (no voltage on the piezoelectric actuator electrodes) can be located anywhere between the upper and the lower mechanical stops. In the most general case, the amplitudes of the strokes from the rest position to the mechanical stops are not symmetric. This dissymmetry can be due to the design itself, the machining and assembly tolerances and also misalignments. If dissymmetric strokes are not expected by design, it is relevant to estimate the minimum voltage necessary to reach the mechanical stop (2) in both directions, in order to reduce the power consumption. The actuator (6) can be advantageously made of a bimorph or a multimorph piezoelectric actuator that allow large bi-directional deflections and large forces. In that configuration the assembly may induce dissymmetry, typically by using glues for the mechanical loop. It could be therefore useful to determine the offset in the position of the membrane (1) at the rest position to optimize the actuator power consumption. The maximum voltages for the two strokes VAct max (up) and VAct max (down) are equal to VAct max in absolute value at the beginning. In practice, the test consists of checking the pressure signal amplitude by reducing first only VAct (up) in order to determine VAct Optimal (up), and then VAct (up) is set again at VAct max and now VAct (down) is varied to determine VAct Optimal (down).
It is important to note that the idle position of the membrane (1) and the minimum force necessary to reach the mechanical stops (2) not only depend on mechanical assembly or machining tolerances but also on environmental conditions. The usual over-driving of the pumping actuators typically prevents under infusion due to these effects but it is not efficient in term of energy consumption. The typical range of pressure variations depends on the foreseen application. For medical application, considering for instance insulin pumps having infusion lines, the head height of the liquid in the infusion line has a major influence on the pressure at the outlet of the pumping chamber. The pumping mechanism should overcome this additional pressure to ensure a correct infusion volume. In such devices having long infusion lines, the over-driving voltage may be as high as two times the minimum voltage necessary to reach the mechanical stop (2) in normal conditions.
The use of the preferred embodiment of the present method (an integrated silicon sensor (104) located within the pumping chamber (111) and between a chamber inlet (102) and a chamber outlet (105), preferably two valves and more specifically two check valves as depicted in
For non-continuous monitoring of the full stroke completion, a safety margin shall be implemented for the optimal voltage to prevent infusion errors due to environmental condition changes that are not monitored via dedicated sensors like thermometers or pressure sensors.
Finally, present invention allows the calculation of the pumping membrane offset by knowing the piezoelectric actuator (6) characteristics and the voltage that is necessary to reach one or several mechanical stops (2). The sub-micron determination of the membrane (103) offset with the integrated pressure sensor (104) in silicon micropump is a smart, accurate, efficient, compact and low cost alternative to other measurement means like optical sensors or proximity sensors.
Method to Determine VAct Optimal
In the further description, the principle will be explained for a single mechanical stop (2). However, the same principle can be extended to systems with two mechanical stops (see
In order to determine the optimal actuation voltage of a system, different methods are proposed as examples in the following paragraphs.
Method 1: Multi Strokes Top-Down Learning Method
The first method is implemented as follows (see
The points 1-4 form a Learning Phase which is used to precisely determine the optimal energy (i.e. actuation voltage) necessary. This Learning Phase can be executed during the priming of the pump. Also, as it can be repeated periodically to take physical changes of the system (fatigue, mechanical deformation, modification of environmental conditions . . . ) into account or even to adapt to a changing environment.
Method 2: Single Stroke Bottom-Up Learning Method
The bottom-up method is implemented as follows (see
This method illustrated in
Other Convergence Methods
The three methods presented above are convergence methods that use sensor data to optimize the voltage value and converge to VAct Optimal. However, the methods to converge to VAct Optimal are numerous and not limited to these three. Also, an algorithm can be used that allows finding the optimal voltage within the shortest time, by using voltage steps ΔV that start with large values and decrease progressively, following for example a geometric series (½, ¼, ⅛, 1/16, . . . ).
Method 4: Modulation Learning Method
This modulation method which is illustrated in
The definition of AC voltage signal is not limited to the square signal represented on
When using a bimorph or a multimorph piezoelectric bender, it is also possible not to apply the AC voltage signal on the electrode that is actuated, but on the other electrode(s), as represented on
The present invention is not limited to the above described embodiments which are given as examples that should not be construed in a limiting manner. Variants are possible with equivalent means and within the scope of the present invention. For example, the method and device of the present invention may be used with other actuators than a piezoelectric actuator as described above.
Number | Date | Country | Kind |
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10196809 | Dec 2010 | EP | regional |
Filing Document | Filing Date | Country | Kind | 371c Date |
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PCT/IB2011/055771 | 12/19/2011 | WO | 00 | 6/24/2013 |
Publishing Document | Publishing Date | Country | Kind |
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WO2012/085814 | 6/28/2012 | WO | A |
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Number | Date | Country | |
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20130272902 A1 | Oct 2013 | US |