FIELD OF THE INVENTION

The present invention relates to battery powered medical devices, such as extracorporeal in sulin pumps as well as methods for powering up such battery-powered medical devices. The method especially relates to testing battery in the powering up.

BACKGROUND OF THE INVENTION

Battery-powered medical devices are used in large and increasing numbers in a plurality of diagnostic or therapeutic applications. A field to which reference is made in the following for exemplary purposes are extracorporeal insulin pumps that are carried by a Person with Dia- betes (PwD) substantially continuously in the context of Continuous Subcutaneous Insulin Infusion (CSII).

Such extracorporeal insulin pumps and a variety of other medical devices are powered by a general-purpose battery that is removably arranged in a corresponding battery compartment of the medical device. When empty, the battery is typically replaced directly by the user. Battery-powered medical devices are typically designed to monitor the battery and provide an alarm or alert to the user when the battery approaches emptiness and needs to be replaced. Further it is common for battery-powered medical devices to carry out battery tests as part of a powering-up routine after replacing the battery. Thereby, it is ensured that the newly in serted battery is in fact capable of powering the medical device. For testing the battery of a medical device, a number of approaches have been developed and generally depend on volt age and internal resistance measurements.

SUMMARY OF THE INVENTION

Executing battery tests according to the prior art, however, is generally associated with a sub stantial stress to the battery, which may result in an unexpected power breakdown. This may especially occur if a generally unsuited battery is used, or if a weak or substantially empty battery is mistakenly used instead of a fresh battery. If such power breakdown occurs when powering up the medical device, the medical device may completely stop operation without providing any warning or alarm to the user, which is known to be a reason of concern and weary for some users. Further, no information regarding the battery test is in this case stored in the history memory or history file of the medical device, thereby complicating the diag nostics of the power breakdown reason and further being critical from a regulatory point of view.

It is an overall objective of the present invention to improve the state of the art regarding battery tests of a battery-powered medical device. Favorably, the risk of unexpected power breakdowns due to a weak or empty battery is avoided or at least reduced.

The overall objective is achieved by the subject mater of the independent claims, with par- ticular end/or exemplary embodiments being defined by the dependent claims as well as the overall disclosure. A method for powering up a medical device powered by a battery includes executing an initial battery test. The initial battery test including the steps of:

a) determining a no-test-load voltage of the battery without a test load being

connected to the battery ;

b) providing an alarm if the no-test-load voltage is below a predetermined

no-test-load voltage threshold and terminating the method;

c) if the no-test-load voltage U _{NoTest Load} is above the no-test-load voltage threshold executing the steps of.

cl) determining a test-load voltage U of

the battery with a test load being connected to the battery ;

c2) comparing a difference voltage AU between the no-test-load voltage U _NoTestLoad and the test-load voltage with a difference voltage threshold the difference voltage threshold being predefined in de

pendence of the no-test-load voltage

c3) if the difference voltage AU is above the difference voltage threshold

providing an alarm; wherein the method further includes executing subsequent steps of the method if the differ ence voltage AU is below the difference voltage threshold

A battery-powered medical device may include:

- a battery compartment , the battery compartment being designed to removably hold a battery and contact elements for electrically contacting the battery;

- a test load , the test load being selectively coupleable to the battery ; - a control circuit , the control circuit being configured to execute a method for powering up the medical device upon a battery being inserted into the battery compartment .

The method for powering up the medical device may be a method according to any embodi ment as described above and/or further below.

The battery generally be of any suited type. In typical embodiments, the battery is a generally available standard battery, such as for example, a AA or AAA cell of rechargeable or non- rechargeable type. The battery may also be made of a number of individual batteries in series. It is noted, however that the present invention is not limited to particular types of battery, but that an in principle any type of battery, being it a non-rechargeable battery (primary cell) or a rechargeable battery (secondary cell) may be used in accordance with the specifications and requirements of the medical device. The battery compartment is generally designed to allow battery replacement by a user.

Since the battery is contacted via contact elements of the battery compartment, the transition resistance between the contact elements and the battery terminals of the battery acts in series to the internal resistance of the battery as such. The combined resistance is in this document referred to as effective internal resistance A _έ . In some typical embodiments, at least one of the contact elements is realized as a contact spring. In this document, the reference to the battery voltage generally refer to the terminal voltage that can be measured in the operational medical device, taking into account the voltage drop over the effective internal resistance i? _j . Subsequent steps of a method for powering up the medical device may include, for example, memory checks, communication controller checks, electrode checks, sensor checks, alarm checks, general checks of the medical device circuitry, tests of acoustic and/or tactile indica tion devices, such as loudspeakers buzzers or vibrators, display tests, and general initialization steps as generally known in the art as well as a further battery test as explained in more detail below. Some of these subsequent steps may be associated with a substantial power consump tion and accordingly substantially stress the battery. In accordance with the present inven tion, these subsequent steps are only executed if the initial battery test is passed successfully. It is to be understood that the medical device draws, when performing any operation and in particular when executing the initial battery test, a baseline current that cannot be avoided. As a consequence, the true open-circuit voltage U ₀ of the battery is not available and cannot be measured, since the baseline current will in any case cause a voltage drop over the effective internal resistance. The baseline current is drawn by the control circuitry in operation. In the following, the baseline current during the initial battery test is generally assumed as constant.

When determining respectively measuring the no-test-load voltage in step (a), the baseline current is the only current that is drawn from the battery. Consequently, the battery load is minimum and the no-test-load voltage is as close as possible to the open-circuit voltage.

In step (b) of the method, an alarm is provided and the method is terminated, i. e. the subse quent steps are not executed, if the no-test-load voltage is below a predetermined no-test- load voltage threshold. This step ensures that the subsequent steps, of the initial battery test are only executed if the battery is at least capable of providing the power that is required for such steps. Very weak or close-to-empty batteries are accordingly sorted out in this step. The alarm may be provided, like further alarms, on one or more indication devices of the medical device, indicated on a display of the medical device and/or provided on a remote device, such as a remote control or smart phone. In step (cl), a farther voltage of the battery is determined respectively measured as test-load voltage with a test load being connected to the battery . Connecting and disconnecting the test load is controlled by the control circuit of the medical device. For this measurement, an additional test load current is drawn from the battery in addition to the baseline current, resulting a larger voltage drop over the effective internal resistance.

The test load and the test load current are selected such that connecting the test load does not significantly stress the battery and may therefore be considered as "weak" test load. The test load current only needs to be sufficiently large to result in a safely measurable difference voltage between the no-test-load voltage and the test-load voltage. In step (c2), the difference voltage AU between the no-test-load voltage U _NoTes tLoad ^as deter mined in step (b) and the test-load voltage as determined in step (cl) is compared with a difference voltage threshold. This difference voltage threshold is predefined in dependence of the no-test-load voltage. A relation between the difference voltage threshold and the no-test-load voltage y be stored in a memory of the control

circuit , for example by way of a mathematical function or in form of a look-up table.

In dependence of the comparison result, an alarm is provided in step (c3) as explained before if the difference voltage is above the difference voltage threshold and the method terminates. Otherwise, the powering up is continued and completed by executing subsequent steps of the method. The subsequent steps of the method are accordingly only executed if the battery is capable of powering the medical device at for the subsequent steps of the powering up routine respectively method without the risk of a sudden breakdown. It is particularly noted that the initial battery test does not rely on an explicit impedance measurement and does further not require any demanding computational steps. What is re quired are only two voltage measurements and a subsequent threshold comparison. There fore, it can be implemented in an efficient and straight-forward way. The determination of the difference voltage threshold in dependence of the no-test- load voltage is explained further below in more detail.

Overall, the initial battery test is a two-step test with a first step being defined by method steps (a), (b), and the second step being defined by method steps (cl), (c2), (c3).

In an embodiment, the difference voltage threshold is a linear function of the no-test-load voltage. This type of embodiment is particularly favourable with respect to a simple evalua tion with very little computational effort.

In an embodiment, the test load is a constant resistance test load. In a non-limiting example that is typical, e. g. for some types of extracorporeal insulin pumps, the n-test-load voltage may be in a range of, e. g. 1.0V to 1.6Y and a baseline current l _B of ~500mA may

be typical used.

In an embodiment, the initial battery test includes storing a result of the initial battery test in a history memory of the medical device. The initial battery test in accordance with the present discloser ensures that the battery, even if weak or close-to-empty, provides sufficient power for storing the result of the battery test prior to any full breakdown. Storing the result of the battery test is highly desirable for the purpose of device diagnostics and may further be a regulatory requirement. In a particular embodiment, the result is not stored in any case but only if a storing criterion is met that indicates that the battery may be weak. As a minimum, it may be stored whether or not the initial battery test as explained before is passed or failed. In further embodiments, the result may be stored for the first step of the initial battery test as defined by steps (a), (b) and the second step of the initial battery test as defined by steps (cl), (c2), (c3). Further, numerical values such as the no-test-load voltage and the test-load voltage may be stored and/or a binary test result (e. g. "passed" or "failed") may be stored.

In an embodiment, the method includes, if it is determined in step (c2) that the difference voltage AU is below the difference voltage threshold AU _TreSh0i a, executing a further battery test. The further battery test includes drawing a further test load current, thereby stressing the battery beyond a limit that is expected to occur during regular operation of the medical device .

In an embodiment the method may further include before step a):

0) turning on the power of the medical device.

The power may for example be turned on by activating a switch, by establishing a connection between the battery with a conductor of the medical device, such as by means of closing the battery compartment or by inserting of the battery in to battery compartment, by connecting the battery to the battery contacts, etc. This preferably closes the circuitry of the battery with a processor of the medical device. Such switches are generally known to the skilled person and include buttons, transistors, induction switches, relays, etc. In contrast to the initial battery test that is designed not to significantly stress the battery, the further battery test is a dedicated stress test which stresses the newly inserted battery to the limits of regular operation. By way of example for some types of extracorporeal insulin pumps, the further battery test may include drawing a battery current of ~1.0A for 4ms. The further battery test may e.g. be considered as failed if the voltage at the end of the test falls below a predetermined threshold of, e.g. 985mV is fallen below.

In an embodiment, the battery-powered medical device includes one or more DC/DC step- up converter(s), the DC/DC step-up converter (s) powers at least some functional units of the medical device . In an example, the test load of such embodiment is electrically arranged between the battery contacts and an input side of the DC/DC step-up converter(s). Functional units that are powered via DC/DC step-up converter(s) typically include the control circuit, in particular microcontrollers or processors, one or more indication devices or displays as ex plained before, actuators such as a motor in case of an infusion pump, communication inter faces, and the like. Typically, most of the functional components and circuitry of the medical device is powered via DC/DC step-up converter(s). For operation of the medical device, it must be ensured that at any point in time required minimum input voltage at the input side of the side of the DC/DC step-up converter is not fallen below. This requirement also holds true for the initial battery test. In some alternative embodiments, however, the test load is arranged on the output side of a DC/DC step-up converter. In an embodiment, the control circuit comprises a processor or computer and a computer readable storage medium , the computer-readable storage medium comprising instructions which, when executed by the processor or computer cause the processor or computer to con trol execution the method for powering up the medical device . In an embodiment with DC/DC step-up converter(s) as explained before, the processor or computer is typically pow ered via a DC/DC step-up converter.

In an embodiment, the medical device is an extracorporeal insulin pump, the extracorporeal insulin pump being configured to be carried by a user for an extended time period under clothing and/or attached to the body.

In an embodiment the present disclosure is applicable to and useful for a variety of battery- powered devices including any battery-powered medical device including but not limited to a drag infusion pump including an insulin pump, a blood glucose sensor, a continuous glucose sensor, a heart defibrillator, a heart monitoring device, etc. Extracorporeal insulin pumps, however, are particularly critical since their failure may directly result in severe medical com plications and they need to be operable substantially continuously around the clock. Further, they are frequently powered by ordinary general-purpose batteries, such as, for example re chargeable or non-rechargeable AA or AAA cells, and it is known that generally unsuited and/or almost empty batteries are occasionally used or reused by mistake and/or lack of aware- ness. Under such circumstances, a breakdown of the power supply as explained before is likely to occur during the process of powering up.

As known in the art, an insulin pump is designed for the administration of small liquid quan tities in the microliter or sub microliter range with high precision. Further insulin pumps are generally designed to administer drag substantially continuously according to a time-varying basal infusion profile and further administer larger drag amounts on demand. A method for determining the difference voltage threshold Ai/ _TresftoM in dependence of the no-test-load voltage U _{NoTest Load} for use in a method as described above includes t the steps of:

(1) experimentally determining a functional relation between values of an effective inter- nal resistance and values of an open-circuit voltage for which the battery is capa

ble of powering-up the medical device ;

(2) determining a minimum no-test-load voltage of the battery for power

ing up the medical device without a test load being connected to the battery as a func tion of the open-circuit voltage U ₀ based on the functional relation as determined in step (1);

(3) determining a minimum test-load voltage of the battery for powering up

the medical device with a test load being connected to the battery as a function of the open-circuit voltage U _Q based on the functional relation as determined in step (1);

(4) computing the difference voltage threshold from the difference between the minimum no-test-load voltage and the minimum test-load voltage

u Testload; min ⁱⁿ dependence of the minimum no-test-load voltage U _{NoTestLoad>min} with the open circuit voltage as parameter.

In an embodiment, the method includes determining the functional relation between values of the effective internal resistance and values of the open-circuit voltage U ₀ as approxi-

mated linear functional relation.

In an embodiment, the method includes computing the difference voltage threshold a ^s linear approximation.

It is noted that the method for determining the difference voltage threshold kUrrestwid does not need to be implemented in the battery-powered medical device. Only the determined difference voltage threshold in dependence of the minimum no-test-load voltage

UNoTestLoad,min ^is stored in the medical device. Instead, the method for determining the difference voltage threshold in depend

ence of the no-test-load voltage is carried out by a medical device supplier in its facilities. Here, the open-circuit voltage and the effective internal resistance

R _i can be de termined respectively measured.

Further explanations and aspects regarding this aspect of the present invention are provided in more detail below in the context of exemplary embodiment.

BRIEF DESCRIPTION OF THE DRAWINGS

In the following, exemplary embodiments are discussed in more detail with additional refer ence to the figures.

Fig. 1 schematically shows an exemplary battery-powered medical device with a bat- tery;

Fig. 2 shows an exemplary operational flow for powering up a medical device;

Fig. 3 shows exemplary graphs for a threshold difference voltage in dependence of a no-test-load voltage. DESCRIPTION OF THE EMBODIMENTS

Figure 1 shows a battery-powered medical device 1 which is exemplarily an insulin pump together with a battery 2 in a schematic functional view. The battery 2 is removably arranged inside a battery compartment 11 of the medical device 1. Further the battery 2, for example a rechargeable or non-rechargeable AA cell or AAA cell, is modelled as ideal battery 21 with open-circuit voltage U ₀ and an internal resistance R^. The battery 2 is contacted and con nected with the further components of the medical device 1 via battery contacts 11a. The battery contacts 11a have a transition resistance R^. in series with the internal resistance R^ of the battery 2. In combination, the internal resistance R^ of the battery 2 and the transition resistance R _{i 2} form the effective internal resistance I¾. The terminal voltage of the battery 2 is referred to as U.

The medical device 1 further includes a DC/DC step-up converter 14 that is connected to the battery contacts 11a. The medical device 1 further includes a control circuit 15 that is con nected to the output side of the DC/DC step-up converter. The control circuit 15 as well as further components as explained below are accordingly powered from the battery 2 via the DC/DC step-up converter 14.

The control circuit 15 includes a processor 151 with corresponding software respectively firmware code, memory 152 and a voltage measurement circuit 153 for determining respec tively measuring the terminal voltage U of the battery 2. Memory 151 may include both pro- gram storage that stores software respectively firmware code for processor 151 as well as Ran dom Access Memory RAM as data memory. Further, control circuit 15 controls opening and closing of switch 13. Via switch 13, a constant resistance test load Rf _est test load that is im plemented as can be connected to the battery in parallel to the contact elements 11a.

The current that is drawn by the test load Rf _est if switch 13 is closed is the test load current hest- The current I that is drawn by the medical device 1 apart from the test load current Ijest is referred to as 1. During an initial battery test as explained further below, it is the base line current I _B .

It is notated that processor 151, memory 152, and voltage measurement circuit 153 may also be integrated e. g. in form of a microcontroller as core element of control circuit 15. The control circuit 15 may and typically does further comprise a variety of further components and functional units as generally known in the art.

The battery-powered medical device 1 in form of an extracorporeal insulin further includes an actuator 16 in form of an electric motor, a display 17 and at least one acoustic and/or tactile indication device 18, all of which operate under control of the control circuit 15.

It is noted that the design as shown in Figure 1 is schematic and simplified for the sake of clarity and conciseness and in order to focus on aspects of particular relevance in the context of the present invention. By way of example more than one DC/DC step-up converters may be present that supply different functional components shown DC/DC step-up converter may be omitted. Further, the test load R _Test may be arranged on the output side of the DC/DC step-up converter 14. Further, the test load Rfest is not necessarily realized by a standard constant resistor, but may be realized by other circuitry such as a FET to form a controlled resistor. The control circuit 15 implements a method for powering up the medical device 1 which is explained in more detail with additional reference to Figure 2. The operational flow starts in step S where battery 2 is into the battery compartment 11, resulting in the medical device 1 and in particular the control circuit 15 being supplied with power. In step SOI, the voltage U is measured via the voltage measurement circuit 153. In this state, the switch 13 is open, and the measured voltage is accordingly the no-test-load voltage, with as baseline current.

In subsequent step S02, the no-test-load is compared with a no-test-load

voltage threshold U _T ureshoid,NoTestLoad that is stored in memory 152 and the operational flow branches in dependence of the result. If the no-test-load voltage is below the no-

test-load voltage threshold the operational flow proceeds with step S03.

In Step SOS an alarm is generated and indicated via display 17 and indication devices 18. Fur ther, a corresponding entry is written into a history memory which is part of memory 152. Subsequently, the operational flow ends with step E and the powering up is terminated. The alarm may be indicated until the battery 2 is fully emptied respectively removed. In an exem plary realization where the battery 2 is a an ordinary, commercially available standard cell and the no-test-load voltage threshold ma be, for example 1000 mV re

spectively 1 V.

If it is determined in step S02 that the no-test-load voltage is above the no-test-

load voltage threshold the operational flow proceeds with step S04. In

step S04, the voltage U is measured via the voltage measurement circuit 153 with switch 13 being temporarily closed. The measured voltage is accordingly the test-load voltage, U = and the current that is drawn from the battery 2 corresponds to the sum of the

baseline current I and the test current

In subsequent step S05, the a difference voltage is determined and compared with a difference voltage threshold which is predefined in depend-

ence of the no-test-load voltage The relation between the difference voltage threshold MJ _TreshoU and the no-test-load voltage may be stored in and retrieved

from memory 152 in form of a look-up table or may be provided in form of an equation

which may especially be a linear equation and is evaluated by control circuit 15, in particular processor 151. This aspect is also discussed further below.

If it is determined in step S05 that the difference voltage MJ is above the difference voltage threshold MJ _TreshoM , the operational flow proceeds with step S06. In Step S06 an alarm is generated and indicated as explained before in the context of step S03 and a corresponding entry is again written into the history memory. Also like in step S03, the operational flow ends with step E and the powering up is terminated.

If it is determined in step S05 that the difference voltage AU is below the difference voltage threshold the operational flow proceeds with step S07 where the powering up is continued and completed. Step S07 may include executing a further battery test as explained before in the general description. In the following, the functional relation between the difference voltage threshold

and the no-test-load voltage is discussed in more detail.

In investigating the start-up behavior of a battery-powered medical device and in particular an extracorporeal insulin pump as explained before, it is found that correct start-up is in any case possible if the effective internal resistance ¾ meets the condition

Consequently, for the effective internal resistance 1¾ being given, the open-circuit voltage U ₀ needs to meet the condition

Further, it can be seen from Fig. 1 that the following applies:

with Eqn. (2a) applying during the initial battery test with switch 13 being open and Eqn. (2b) applying during the initial battery test with switch 13 being closed.

In the following, a voltage on the output side of the DC/DC step-up converter 14 (I. e., the supply voltage of control circuit 15) is referred to as U'. Further, the (virtual) load resistance that is seen by the battery 2 as drawing the baseline current I _B is referred to as R _B . Eqn (2a), (2b) can accordingly be re-written as

By re-arranging Eqn. (3a), (3b) fo and , respectively and solving the

resulting quadratic equations, the following is obtained:

Eqn. (4a), 4b) accordingly express the voltages for the battery 2 that

can be measured in the medical device 1 in operation as function of the generally unknown open-circuit voltage U ₀ and effective internal resistance

In Eqn. (4a, 4b), the effective internal resistance may be substituted by its threshold value for which a powering-up is possible according to Eqn. (la), resulting in equations for the mini- mum no-test-load voltage UNoTestLoad, min and the minimum test load voltage U _{TestLoad Jnin} with the open-circuit voltage U ₀ as sole parameter.

The graph of Figure 3 schematically shows the difference voltage

when plotted over the no-test-load voltage with the open-circuit volt as parameter. Curve A is obtained from directly applying Eqn. (4a), (4b). In a region II

above curve, A powering up the medical device 1 is not possible, while in the area I below the curve, powering up is possible. Curve A accordingly defines the difference voltage thresh old as a function respectively in dependence of the no-test-load voltage

· Curve A may be implemented in the control circuit 151 by way of a mathemat

ical function that is evaluated by the processor 151 or may be implemented as look-up table in the memory 152. A further computational simplification as explained in the following may be used in a further embodiment. Instead of curve A, the linear approximation of curve B is used. Curve B may be obtained as tangent to curve A at a reference value AU ₀ . Like curve A, Curve B may be im plemented in the control circuit 151 by way of a (linear) mathematical function that is eval- uated by the processor 151 or may be implemented as look-up table in the memory 152. In an exemplary implementation, the reference value may be in the range of 1 mV.