Infusion device and method at the infusion device

Abstract

An infusion device and a method at an infusion device, wherein the infusion device includes: a receptacle configured to receive a syringe; a plunger driver configured to releasably engage an end of a plunger of the syringe; a controller configured to control travel of the plunger driver in at least one direction; wherein the controller is configured with functions including a first function protected using first authorization that is enabled or not enabled to provide authorized access; and a user interface with a display and one or more input elements. The first authorization may include an access code enabling a health care professional to change settings at the controller for controlling infusion in accordance with the settings. The method enables authorized resetting of the access code.

Description

[0001] Infusion device and method at the infusion device

[0002] The present disclosure relates to an infusion device including a controller and a method at the infusion device including controlling access to the controller.

[0003] INTRODUCTION

[0004] Patients with chronic diseases and conditions may require regular injections of intravenous and / or subcutaneous medicament treatment. For some medicament types, this may also require injection on a regular basis as determined by a treating physician. For certain patients, including younger and less-able patients, care is often provided in a clinical setting. However, this requires patients and caregivers to be present at a treatment location. Many clinics therefore, when possible, educate patients and caregivers so they can administer intravenous infusion at home. This reduces burdens on all parties. However, difficulties may arise when self-administering treatment, including determining correct dosages and ensuring the infusion takes place at the appropriate rate. Improvements in existing methods are desired.

[0005] Certain treatments involve the infusion of a volume of a reconstituted medicament (i.e. , a dried drug medicament restored to its original state by adding liquid). The amount of reconstituted medicament necessary may depend on many factors, including the type of medicament, the condition of the patient, and the type or stage of the disease (or condition). For some diseases, such as e.g. hemophilia, the presence of clotting factor antibodies may also affect the volume of treatment that must be infused. In addition to dosage, intravenous treatments must be administered at a controlled rate, as the capacity of a given vein to receive the drug, in addition to blood flow rate and volume in the vein, is limited. It is therefore possible to infuse an intravenous treatment at an excessive flow rate, particularly if administered via a syringe. This can result in too much drug being infused and can even result in physical damage to the vein. This is particularly true for longer- duration infusions, which require greater control over a longer period of time. Excessive flow rates, at the extreme, can cause a vein to “blow out” or balloon, potentially injuring the patient. Therefore, controlling the flow rate and volume of an infusion is imperative. Moreover, certain drugs, including hemophilia drugs, are prohibitively expensive. Thus, administering the correct amount and at the correct rate reduces the likelihood of wasted product, and thus reduces expense.

[0006] In many situations, it is advantageous that a user of an infusion device is able to access the controller of the device. For instance, it could be the case that a dose setting must be adjusted under supervision by a remote Health Care Person (HCP) so that it is avoided that the device must be sent or brought to the HCP or that the HCP must come to the user for adjusting the setting.

[0007] Many modern infusion devices can be accessed remotely, for instance changing device settings, updating software or other reasons. For security reasons, it may be required that an access code must be physically entered to the device in order for allowing remote access to the device.

[0008] This means that the user of the device must know the access code, which may constitute a security risk, because it allows the user to change dose settings or other settings of the device without involving an HCP.

[0009] It is therefore an object to provide an infusion device and a method for controlling the access to an infusion device, which maintain the advantages of the solutions known in the art but avoid the above-mentioned security risk.

[0010] SUMMARY

[0011] An object is to provide a method at an infusion device and an infusion device enabling only authorized access to at least one protected function at the infusion device. The infusion device is e.g. a portable continuous infusion device, including an electronic controller with only limited processing power and not having communication network access.

[0012] It is a further object to enable only authorized access while being compliant with a data-protection-regulation, e.g. the general data-protection regulation, GDPR, drafted and passed by the European Union (EU).

[0013] There is provided: A method at an infusion device, wherein the infusion device includes: a receptacle configured to receive a syringe; a plunger driver configured to releasably engage an end of a plunger of the syringe; a controller configured to control travel of the plunger driver in at least one direction; wherein the controller is configured with functions including a first function protected using first authorization that is enabled or not enabled to provide authorized access; and a user interface with a display and one or more input elements; the method comprising: in accordance with a determination that the first authorization, requiring an access code value, is not enabled: generating a display code value, based on a first value and a second value, using a display code generating algorithm; generating an unlock code value, based on the display code value only, using an unlock code generating algorithm; displaying the display code, via the display, and forgoing displaying the unlock code; receiving a third value, via the input elements, entered by a user; in accordance with a determination that the third value corresponds with the unlock code value, enabling access, via the user interface, to reset the access code and / or enabling the first authorization; in accordance with a determination that the third value fails to correspond with the unlock code value, forgoing enabling access, via the user interface, to reset the access code (PIN) and forgoing enabling the first authorization.

[0014] An advantage is that the infusion device, e.g. a portable e.g. body-worn continuous infusion device, enables resetting of the access code value until a correct unlock code value is inputted to the infusion device while reducing the risk of providing unintended access to the first function. In some examples, the first function enables changing settings at the controller for controlling infusion, at the infusion device, in accordance with the settings. On the one hand, it may be associated with serious health risks if unintended access to the first function is given. On the other hand, it may also be associated with serious health risks if access, via the user interface, is irreversible blocked.

[0015] In particular, the infusion device enables only authorized access to at least the first function, at the controller. Other functions at the controller may or may not require authorization. In some examples, a health care professional, HOP, is authorized to access the first function to change settings related to a patient’s prescription, whereas no authorization (of a patient) is required to receive an infusion via the infusion device.

[0016] An HOP may operate the infusion device, via the user interface, to reset the access code value by inputting a code value identical to the unlock code. The HCP may obtain the code value, identical to the unlock code, from a support facility based on stating the display code only. Essentially, the display code itself is void of information revealing the identity of the patient let alone the identity of the infusion device. Thereby it is possible to enable access to the first function at the infusion device while not leaking or enabling a leak of sensitive information associated with the patient.

[0017] Advantageously, the infusion device can be compliant with a data-protection- regulation, e.g. the general data-protection regulation, GDPR. In particular the infusion device can be an infusion device including an electronic controller with only limited processing power and not having wired and / or wireless communication network access. The electronic controller may include one or more so-called micro-controllers or complex programmable logic devices. The infusion device typically includes a battery, e.g. a coin-cell-battery or a penlightbattery.

[0018] The support facility is configured or arranged in the form of e.g. a call-centre, to issue an unlock code value to an identified HCP in response to receiving a display code value. The support facility may require the identity or authorization from the HCP as a condition for issuing an unlock code value based on a display code value. Thus, the call centre can refuse to issue an unlock code to a person not identifying her- / himself as an HCP e.g. an HCP registered at the call centre. The HCP, rather than the patient prescribed to receive infusions from the infusion device, is thus able to enter the unlock code and e.g. change settings of the infusion device via the first function. The support facility may use a lookup table or an app running on an electronic device to obtain and issue the unlock code value.

[0019] The display code value can be considered a pseudo-random code drawn from a set consisting of a finite number of code values e.g., limited to about 1000 unique value. Alternatively, limited to about 100 unique values or about 10,000 unique values.

[0020] The unlock code value is generated based solely on the display code and changes when the display code value changes. Thereby, an attempt to guess the unlock code is at best equivalent to statistical sampling with replacement.

[0021] In some examples, e.g. in all examples, the infusion device forgoes displaying the unlock code value at all times.

[0022] As stated, the first function is protected using first authorization that is enabled or not enabled to provide authorized access. For instance, the first authorization is not enabled to provide authorized access following reaching or exceeding a threshold number of failed attempts to input the access code. When the first authorization is not enabled to provide authorized access, authorization is locked. When the first authorization is enabled to provide authorized access, a valid access code provides authorization. For instance, the first authorization is enabled to provide authorized access following a reset of the access code. For instance, each access code ceases to provide first authorization at times when the first authorization is not enabled.

[0023] In some aspects the method comprises: in response to a detection that the first authorization is enabled to provide authorized access to the first function, enabling the controller to move the plunger driver in at least one direction without requiring authorization, via the user interface, including the access code value. An advantage is that a patient can use the infusion device, for prescribed infusions, e.g. prescribed continuous infusions, without the hindrance of authorization.

[0024] In some examples, a patient needing prescribed infusions, using the infusion device, can operate the infusion device, without authorization at the infusion device, to receive the prescribed infusions in accordance with settings operatively protected from being changed, via the user interface, using the first authorization.

[0025] In some examples, the first authorization is not enabled to provide authorized access following reaching or exceeding a threshold number of failed attempts to input the access code; and / or at a time before the unlock code is entered a first time (e.g. when the infusion device is not yet set up by the HCP), and / or at a time during reset, before a new access code is set.

[0026] In some examples, a detection that the first authorization is not enabled to provide authorized access to the first function, disables the controller to move the plunger driver in at least one direction with or without authorization via the user interface.

[0027] In some aspects the method comprises: receiving a fourth value, via the one or more input elements; in accordance with a determination that the fourth value corresponds with the access code value, enabling access to the first function; in accordance with a determination that the fourth value fails to correspond with the access code value, forgoing enabling access to the first function.

[0028] An advantage is that an HCP entrusted with the access code value can use the first function to e.g. change settings defining an amount and / or rate and / or frequency of infusion.

[0029] In some examples, only an HCP is entrusted by an institution, external to the infusion device, to obtain access to the unlock code based on the display code. Only the HCP is thus enabled to reset the access code via the user interface e.g. in a situation wherein the first authorization, protecting the first function, ceases to be enabled e.g. when a threshold number of failed attempts to authorize is reached or exceeded.

[0030] In some aspects the method comprises: in accordance with a determination that the fourth value fails to correspond with the access code value: forgoing enabling the controller to move the plunger driver in at least one direction and forgoing enabling the first function; and / or setting the first authorization to be not enabled.

[0031] An advantage is that the risk of enabling infusion based on an erroneous setting is reduced.

[0032] In some aspects of the method the first function, protected using the first authorization, includes: receiving, via the input elements, one or more inputs corresponding with settings at the controller for controlling infusion, at the infusion device, in accordance with the settings.

[0033] An advantage is that the risk of inadvertent operation of the infusion device to infuse an unhealthy dose of medicament can be prevented or at least reduced.

[0034] In some examples, the first settings of the controller are associated with controlling travel of the plunger driver. In some examples, the first function at the controller enables the controller to generate signals controlling travel of the plunger driver at least in a first direction.

[0035] In some aspects the method comprises: in accordance with reaching and / or exceeding a threshold number of consecutive determinations that the fourth value fails to correspond with the access code value, setting the first authorization, requiring the access code value, to be not enabled.

[0036] An advantage is that an HCP may be allowed a few attempts to enter a code correctly. This may give the HCP a better chance to operate the infusion device as intended without jeopardizing prevention of unintended access to the first function.

[0037] In some examples, a determination that one value corresponds with another value includes a determination that the one value is identical to the other value.

[0038] In some examples, a few consecutive determinations include less than six, e.g. less than four consecutive determinations that that the third value fails to correspond with the unlock code value.

[0039] In some examples, the method at the infusion device comprises: starting a timer; in accordance with reaching and / or exceeding a timer threshold, setting the first authorization, requiring the access code value, to be not enabled. The timer may be set at a time when the display shows a prompt to enter the access code or at a time when the third value is received, via the input elements, e.g. a first time.

[0040] In some aspects the method comprises, comprising: in accordance with a determination that the third value fails to correspond with the unlock code value: generating the display code value anew based on the second value and based on obtaining the first value anew from the generator; and generating the unlock code value anew in response to the display code being generated anew.

[0041] An advantage is that the infusion device is not completely and persistently blocked following one or more unsuccessful attempts to input the unlock code value. Rather, the infusion device keeps being accessible for continued attempts to input an unlock code, however each time based on a new display code.

[0042] An attempted approach to gain access to the first functions based on repeatedly trying to guess the unlock code value likely will be in vain. The attempted approach will at best correspond to sampling with replacement, and not to sampling without replacement.

[0043] In some examples, the first value obtained anew from the generator is likely having a first value different from the previous first value. The generator may generate values with some degree of repetitiveness, e.g. pseudo-random values. The display code values may thus show a corresponding repetitiveness.

[0044] In some examples, the unlock code value generated anew overwrites a precedingly generated unlock code value. A current unlock code value is thus the only unlock value for determining that the third value corresponds with the unlock code value or fails to correspond with the unlock code value.

[0045] In some aspects the method comprises: in accordance with a determination that the third value corresponds with the unlock code value, and in response to detecting a reset of the access code, enabling the first authorization.

[0046] An advantage is that a reset of the access code is required before a newly set access code value can provide access to the first function protected using the first authorization. A previous access code value is thereby dismissed and ceases to provide authorization to the first function.

[0047] In some aspects of the method, wherein the controller is configured to enter one or more states including a first state and / or to detect one or more events including a first event, the method comprises: detecting that the controller has entered the first state and / or that the first event is detected; and setting the first authorization, requiring an access code value, to be not enabled in response to detecting that the controller has entered the first state and / or that the first event is detected.

[0048] The first event may include that the controller is ready e.g. after insertion of a battery in a battery compartment at the infusion device. The first state may include that the controller is running a start-up procedure or has completed a start-up procedure e.g. after insertion of a battery in a battery compartment at the infusion device. In some examples, the first event correspond to receiving an input via the input elements.

[0049] In some aspects the method, the controller includes a generator generating time-varying values; the first value is obtained from the generator generating time-varying values including the first value; and the second value is based on a serial number associated with the infusion device.

[0050] An advantage is that the method can be performed by an infusion device including an electronic controller with only limited processing power and not having wired and / or wireless communication network access. The electronic controller may include one or more so-called micro-controllers or complex programmable logic devices. The infusion device typically includes a battery, e.g. a coin-cell-battery or a penlight-battery.

[0051] In some examples, the generator generating time-varying values includes a timer, generating time-codes, or a counter running in an endless loop and continually counting up until a reset or alternately counting up-and-down.

[0052] In some aspects of the method, the display code generating algorithm combines the first value and the second value based on: one or more of: multiplication, addition and subtraction, not including division; and bit-shifting.

[0053] An advantage is that the controller can generate the display code, using the display code generating algorithm, based on only limited processing resources. Processing resources may be limited in terms of e.g. processing speed, memory, arithmetic-logic units, and bit-width.

[0054] In some examples, the first code and the second code are combined using one or more of multiplication, addition and subtraction. In some examples, the display code value is generated via a bit-shifting operation.

[0055] The controller at the infusion device is configured to generate the display code based on e.g. addition and bit-shifting. Bit-shifting may be applied to any of the values before or after addition and / or subtraction and / or multiplication.

[0056] An advantage is that the safety is improved. In some examples, a valid access code value enables access to more frequently used functions of the infusion device, whereas an unlock code enables access to a first-time use or access to renew a period of use of the infusion device.

[0057] In some examples, the first function does not include one or more functions enabling the controller to generate signals controlling travel of the plunger driver.

[0058] In some aspects of the method, the time-varying values recurrently increment or decrement at a rate faster than once per 30 minutes, such as faster than once per minute, such as faster than or at once per second.

[0059] In some aspects of the method the time-varying values recurrently increment or decrement at a rate slower than once per 100 milliseconds, such as slower than or at once per second, such as slower than once per minute.

[0060] An advantage is that the risk of drawing the same display code two or more consecutive times is reduced.

[0061] In some examples, the time-varying values correspond with a time of day or a time including a date.

[0062] In some examples, the display code includes a 3-digit value. In some examples, the unlock code includes a 4-digit value.

[0063] In some aspects of the method, the display code value consists of a first number of characters; the unlock code consists of a second number of characters; and the second number is different from the first number.

[0064] An advantage is that the risk of the HCP confusing the display code and the third code value corresponding with the unlock code is reduced.

[0065] In some examples, the first display code value consists of three, four or five characters, and the unlock code consists of four, five or six characters.

[0066] In some aspects of the method, the infusion device is associated with a support facility; and the method comprises: at the support facility: receiving a value corresponding with the display code; determining a code value identical to the unlock code value based on the value corresponding with the display code and an implementation of the unlock code generating algorithm; and delivering the third value to a user based on the code value identical to the unlock code value.

[0067] An advantage is that the support facility can provide the unlock code value without obtaining information, including code values, revealing a serial number of the infusion device and revealing information identifying the patient using the infusion device to receive infusions. The support facility is configured or arranged to issue an unlock code value in response to receiving a display code value.

[0068] The support facility may operate under a non-publicly available phone number and / or require a foregoing registration of the HCP. The risk of revealing an access code to a non-qualified person may thereby be sufficiently reduced.

[0069] The support facility is separate from the infusion device. The support facility is e.g. operated from a remote location.

[0070] In some aspects of the method, the support facility includes a call centre.

[0071] The call centre may use a lookup table or an and an app running on an electronic device to determine the third value based on the code value identical to the unlock code value.

[0072] There is also provided:

[0073] An infusion device, comprising: a receptacle configured to receive a syringe; a plunger driver configured to releasably engage an end of a plunger of the syringe; a controller configured to control travel of the plunger driver in at least one direction; wherein the controller is configured with functions including a first function protected using first authorization that is enabled or not enabled to provide authorized access; and a user interface with a display and one or more input elements; wherein the infusion device is configured to execute the method according to any of claims 1-12.

[0074] There is also provided:

[0075] A computer-readable medium, comprising: computer readable instructions making an infusion device perform the method according to any of claims 1-12 when executed by the controller at the infusion device; wherein the infusion device includes: a receptacle configured to receive a syringe; a plunger driver configured to releasably engage an end of a plunger of the syringe; a controller configured to control travel of the plunger driver in at least one direction; wherein the controller is configured with functions including a first function protected using first authorization that is enabled or not enabled to provide authorized access; and a user interface with a display and one or more input elements.

[0076] BRIEF DESCRIPTION OF THE FIGURES

[0077] Various examples are described hereinafter with reference to the figures. Like reference numerals refer to like elements throughout. Like elements will, thus, not be described in detail with respect to the description of each figure. It should also be noted that the figures are only intended to facilitate the description of the examples. They are not intended as an exhaustive description of the claimed invention or as a limitation on the scope of the claimed invention. In addition, an illustrated example needs not have all the aspects or advantages shown. An aspect or an advantage described in conjunction with a particular example is not necessarily limited to that example and can be practiced in any other examples even if not so illustrated, or if not so explicitly described. figs. 1 A and 1 B show an example of an infusion device; fig. 1C shows a housing of the infusion device; fig. 1 D shows an infusion with a syringe connected to an infusion line; figs. 1 E-H show some of the internal parts of the infusion device shown in figs. 1A and 1 B; fig. 11 shows a schematic overview of the relation between some of the internal parts of the infusion device shown in figs. 1 A and 1 B; fig. 2 is a flow chart showing the procedure for changing an access code; fig. 3 shows an example of how a display code can be calculated; fig. 4A is a flow chart showing the procedure for changing an access code; fig. 4B shows a table used for the determination of an unlock code; fig. 5 shows a flowchart for a first method performed by the controller amd enabling authorized resetting of an access code; and fig. 6 shows a flowchart for a second method performed by the controller and enabling authorized access a function at the infusion device and resetting of the access code.

[0078] DETAILED DESCRIPTION

[0079] Exemplary examples will now be described more fully hereinafter with reference to the accompanying drawings. In this regard, the present examples may have different forms and should not be construed as being limited to the descriptions set forth herein. Accordingly, the examples are merely described below, by referring to the figures, to explain aspects. As used herein, the term "and / or" includes any and all combinations of one or more of the associated listed items. Expressions such as "at least one of," when preceding a list of elements, modify the entire list of elements and do not modify the individual elements of the list.

[0080] In the drawings, thicknesses of a plurality of layers and areas are illustrated in an enlarged manner for clarity and ease of description thereof. When a layer, area, element, or plate is referred to as being “on” another layer, area, element, or plate, it may be directly on the other layer, area, element, or plate, or intervening layers, areas, elements, or plates may be present therebetween. Conversely, when a layer, area, element, or plate is referred to as being “directly on” another layer, area, element, or plate, there are no intervening layers, areas, elements, or plates therebetween. Further when a layer, area, element, or plate is referred to as being “below” another layer, area, element, or plate, it may be directly below the other layer, area, element, or plate, or intervening layers, areas, elements, or plates may be present therebetween. Conversely, when a layer, area, element, or plate is referred to as being “directly below” another layer, area, element, or plate, there are no intervening layers, areas, elements, or plates therebetween.

[0081] The spatially relative terms “lower” or “bottom” and “upper” or “top”, "below", "beneath", "less", "above", and the like, may be used herein for ease of description to describe the relationship between one element or component and another element or component as illustrated in the drawings. It will be understood that the spatially relative terms are intended to encompass different orientations of the device in use or operation, in addition to the orientation depicted in the drawings. For example, in the case where a device illustrated in the drawings is turned over, elements described as being on the “lower” side of other elements, or "below" or "beneath" another element would then be oriented on “upper” sides of the other elements, or "above" another element. Accordingly, the illustrative term "below" or “beneath” may include both the “lower” and “upper” orientation positions, depending on the particular orientation of the figure. Similarly, if the device in one of the figures is turned over, elements described as “below” or “beneath” other elements would then be oriented ’’above” the other elements. The exemplary terms “below” or “beneath” can, therefore, encompass both an orientation of above and below, and thus the spatially relative terms may be interpreted differently depending on the orientations described.

[0082] Throughout the specification, when an element is referred to as being “connected” to another element, the element is “directly connected” to the other element, or “electrically connected” to the other element with one or more intervening elements interposed therebetween.

[0083] The terminology used herein is for the purpose of describing particular examples only and is not intended to be limiting. As used herein, the singular forms “a,” “an,” and “the” are intended to include the plural forms, including “at least one,” unless the content clearly indicates otherwise. “At least one” is not to be construed as limiting “a” or “an.” It will be further understood that the terms “comprises," "comprising," "includes" and / or "including," when used in this specification, specify the presence of stated features, integers, steps, operations, elements, and / or components, but do not preclude the presence or addition of one or more other features, integers, steps, operations, elements, components, and / or groups thereof.

[0084] It will be understood that, although the terms “first,” “second,” “third,” and the like may be used herein to describe various elements, these elements should not be limited by these terms. These terms are only used to distinguish one element from another element. Thus, “a first element” discussed below could be termed “a second element” or “a third element,” and “a second element” and “a third element” may be termed likewise without departing from the teachings herein.

[0085] "About" or "approximately" as used herein is inclusive of the stated value and means within an acceptable range of deviation for the particular value as determined by one of ordinary skill in the art, considering the measurement in question and the error associated with measurement of the particular quantity (i.e. , the limitations of the measurement system). For example, "about" may mean within one or more standard deviations, or within ± 30%, 20%, 10%, 5% of the stated value.

[0086] Unless otherwise defined, all terms used herein (including technical and scientific terms) have the same meaning as commonly understood by those skilled in the art to which this invention pertains. It will be further understood that terms, such as those defined in commonly used dictionaries, should be interpreted as having a meaning that is consistent with their meaning in the context of the relevant art and will not be interpreted in an idealized or overly formal sense unless expressly so defined in the present specification.

[0087] Exemplary examples are described herein with reference to cross section illustrations that are schematic illustrations of idealized examples, wherein like reference numerals refer to like elements throughout the specification. As such, variations from the shapes of the illustrations as a result, for example, of manufacturing techniques and / or tolerances, are to be expected. Thus, examples described herein should not be construed as limited to the particular shapes of regions as illustrated herein but are to include deviations in shapes that result, for example, from manufacturing. For example, a region illustrated or described as flat may have rough and / or nonlinear features. Moreover, sharp angles that are illustrated may be rounded. Thus, the regions illustrated in the figures are schematic in nature and their shapes are not intended to illustrate the precise shape of a region and are not intended to limit the scope of the present claims. Some of the parts which are not associated with the description may not be provided in order to specifically describe exemplary examples of the present disclosure.

[0088] Figs. 1A and 1 B show an example of an infusion device 100 with a syringe 200 comprising a plunger 202 according to an example of the invention. Fig. 1 B shows the infusion device 100 and the syringe 200 side by side, whereas in Fig. 1A, the syringe 200 is arranged within the infusion device 100 so that the plunger 202 cannot be seen in this figure. The syringe 200 may be supported within the receptacle 120 shown in Fig. 1C such that an end of syringe 200 and / or an infusion line coupled to the syringe 200 extends through a distal end of the infusion device 100. The syringe 200 supported in the receptacle 120 is shown in Fig. 1A and Fig. 1 D, where Fig. 1 D shows an infusion line 210 coupled to the syringe 200.

[0089] In one or more examples, the syringe 200 may be a generic, over-the-counter syringe comprising a plunger 202 that is movable, e.g., by hand, to administer fluids and / or a treatment agent (e.g., medication or drug, such as, for example, a reconstituted drug) for example subcutaneously or intravenously. In other examples, the syringe 200 may be a specially-designed syringe, e.g., that is specifically suited for administering a treatment agent. Further, the syringe 200 may be prefilled with medication, i.e. not needing a syringe filling application where typically the user fills the syringe by withdrawal of medicament I drug from a primary container vial. The infusion device 100 can, e.g., be worn by a patient. The infusion device 100 may be coupled to an infusion line 210 as shown in Fig. 1 D. The infusion line 210 is coupled to a needle 212 with a needle outlet 214 through which the medicament exits the syringe infusion line 210.

[0090] The infusion device 100 as shown in Figs. 1A-B comprises a housing 122 inside which is found a receptacle 120 for receiving the syringe 200. The receptacle 120 may thus be configured to support syringe 200 and to control the syringe 200 for the administration of medicament into and from the syringe 200. An example of the housing 122 and the receptacle 120 is shown in Fig. 1C showing an open empty housing 122. The housing 122 comprises a housing top part 124 and a housing bottom part 126. The housing top part 124 of the infusion device 100 is movable with respect to the housing bottom part 126 such that access to the interior of the infusion device 100 is possible for mounting of a syringe 200 inside the infusion device 100. The housing top part 124 may secure over an upper edge of the housing bottom part 126 and may form an interior volume of the infusion device 100 when in a closed state. The housing top part 124 may be connected to the housing bottom part 126 by one or more hinges 128, allowing the housing top part 124 to rotate relative to the housing bottom part 126 when transitioning between an open state and the closed state. Together with the hinges 128, one or more latches or connectors may also be disposed along an edge of the housing top part 124 or the bottom housing part 126 to secure the housing top part 124 to the housing bottom part 126. The one or more latches may be disposed on an edge of the housing bottom part 126 and / or the housing top part 124 that are not shared with the one or more the hinges 128. The housing top part 124 may be preferably opened by pivoting about the hinges 128, revealing the interior volume of the infusion device 100 when inserting syringe 200 into or removing syringe 200 from the infusion device 100. The receptacle 120 may preferably extend along a substantial portion of the infusion device 100 such that a length of the receptacle 120 may be configured to accommodate syringe 200 and the plunger 202 when the plunger 202 is fully extended and positioned within the receptacle 120. However, it is also contemplated that the receptacle 120 may be formed merely by the syringe opening 101 in the infusion device 100, wherein the syringe opening 101 alone may support the syringe 200.

[0091] On the outside of the housing top part 124 (see Figs. 1A-B) is a user interface

[0092] 102 configured to allow a user, such as a health care person, to enter e.g. codes and to access and adjust settings of a controller 112 of the infusion device 100 is also shown in Figs. 1A-1 B. In addition to the user interface 102, a set of plunger moving controllers 103 are seen in Figs. 1A-B. The plunger moving controllers

[0093] 103 may be configured for controlling the movement of a plunger 104 (see Figs. 1 F-H) inside the infusion device 100.

[0094] The infusion device 100 comprises a number of internal parts inside the infusion device 100 as shown in Figs. 1 E-H. In Fig. 1 E, it is seen how the plunger driver

[0095] 104 of the infusion device 100 interacts with the plunger 202 of the syringe 200, the latter which is in contact with a medicament compartment 204 of the syringe 200. The plunger driver 104 is configured to releasably engage a driver end 203 of the plunger 202 and to move the plunger 202 in a longitudinal direction of the syringe 200. The medicament compartment 204 may have a generally cylindrical shape, although other shapes are also contemplated. A portion of the medicament compartment 204 may be disposed within the infusion device 100 while a remaining portion of the medicament compartment 204 may project out through a syringe opening 101. The plunger 202 may be slidably received within the medicament compartment 204. For example, the medicament compartment 204 may include a generally hollow and elongated enclosure and the plunger 202 may be slidingly disposed in the enclosure within the medicament compartment 204. The plunger 202 may extend from the driver end 203 disposed outside the medicament compartment 204 to a medicament end 205 disposed within the medicament compartment 204. The medicament end 205 of the plunger 202 may be in contact with a movable seal 206 with the medicament compartment 204.

[0096] In addition to having a plunger rod mounted on the syringe, the syringe may optionally be mounted without a plunger rod, whereby the plunger (or a piston) in the pump instead is shaped to allow for pressing into the syringe body during delivery of the medicament / drug to the patient. By using a syringe without a plunger rod may allow for other syringe mountings in the pump by axially loading the syringe from e.g. the front end of the pump (not shown in the figures).

[0097] Fig. 1 E also illustrates how the plunger driver 104 is driven by drive train 105 comprising a rotating motor 106, such as a DC motor, via a lead screw 108, which is connected to the motor 106 through a gearing arrangement comprising one or more gears 110.

[0098] The plunger interface between the plunger driver 104 and the plunger 202 may be configured as a ‘push only’ interface moving in a forward longitudinal direction for emptying the syringe as shown in three stages in Figs. 1 F-H. However, the plunger interface may also be implemented for both pushing and pulling, hence allowing a pump to support aspiration (needle in blood vessel) and / or filling the syringe from an external vial primary container. Thus, the lead screw 108 may be configured to engage the driver end 203 of the plunger 202 to move the plunger 202 in a first direction. The lead screw 108 may also be configured to move the plunger 202 in a second direction, opposite the first direction. The lead screw 108 may be configured to engage with and / or grasp the driver end 203 of the plunger 202 when the driver end 203 is located adjacent or close to the lead screw 108. The grapping of the driver end 203 may be obtained by the lead screw 108 being connected to or equipped with a grip arrangement (not shown) gripping the driver end 203 of the plunger.

[0099] The plunger moving controllers 103 as shown in Figs. 1A-B, allows the user to provide input to the infusion device 100 and thereby control the movement of the plunger 202 of syringe 200 when the syringe 200 is supported in the infusion device 100. The plunger moving controllers 103 may comprise two push buttons, one for each opposite direction, which, when pressed, may provide inputs to a controller 112 (see Fig. 11) of the infusion device 100 to control the movement of the plunger 202 in the first direction or in the second direction. The placement of the plunger moving controllers 103 around a middle region of the infusion may allow a user to grip the infusion device 100 with one hand and make inputs to the plunger moving controllers 103 with the user’s thumb. As an alternative to the two plunger moving controllers 103 shown in Fig. 1A-B, a joystick capable of moving and / or tilting in two opposite directions for moving the plunger 202 in the first direction or in the second direction may also be envisioned.

[0100] The user interface 102 may include a digital display and / or touch screen display. As an alternative or in addition to the user interface 102 and the plunger moving controllers 103 shown in Fig. 1A-B, additional user controls may also be envisioned. These may include buttons, switches, or any other interface that is configured to receive input from a user and provide signals to the controller 112 of the infusion device 100. In some examples, user controls may comprise mechanical and / or electronic interfaces that can receive inputs from the touch of a user or a motion imparted by the user and provide signals to the controller 112 of the infusion device 100. Exemplary electronic interfaces include resistive touch, capacitive, or equivalent interfaces. Further still, user controls may be integrated into the user interface 102 by way of a touchscreen display. User controls and the user interface 102 may be preferably disposed on the outside of the infusion device 100.

[0101] Fig. 11 shows a schematic overview of the relation between the internal parts 102, 104, 106, 108, 110, 112 of the infusion device. In Fig. 11, the main controller 112 is also shown. The gearing arrangement comprising one or more gears 110 may comprise a planetary gear 110b and two gear wheels 110a as shown in Fig. 11. Also shown in Fig. 11 is an orientation sensor 114, an orientation sensor self-test system 115, a battery 116 powering the infusion device 100, a driver 117, and a current measuring sensor 118.

[0102] The motor 106 may drive the lead screw 108. The motor 106 may be controlled by the plunger moving controllers 103, user controls, and / or one or more signals generated from a control algorithm stored in the main controller 112.

[0103] The drive train 105 comprises the lead screw 108 that may be configured to be rotated by the motor 106, causing the lead screw 108 to translate in the first direction or in the second direction based on a direction of rotation of the lead screw 108. The lead screw 108 may preferably extend along a length of the infusion device 100 such that the position of the lead screw 108 along the length of the receptacle 120 is controllable. A length of travel of the lead screw 108 may be determined by a length of the lead screw 108. The lead screw 108 may be configured to engage the driver end 203 of the plunger 202 when the plunger 202 is fully extended from or fully inserted into the medicament compartment 204, and anywhere in between. Thus, the lead screw 108 may be configured to engage an extended the plunger 202 and drive the plunger 202 completely into the syringe compartment 204 of syringe 200 to administer and / or otherwise evacuate the entire contents of syringe 200. Similarly, the lead screw 108 may be configured to engage the plunger 202 regardless of how far the plunger 202 is inserted into the medicament compartment 204, and to retract the plunger 202 in the syringe compartment 204 of syringe 200 to load and / or otherwise fill syringe 200.

[0104] The motor 106 of the infusion device 100 may receive inputs from the plunger moving controllers 103 and may either directly drive the lead screw 108 or indirectly drive the lead screw 108 via the drive train 105.

[0105] The drive train 105 may include one or more gears 110 to reduce or increase the rotational speed and torque of the motor 106 on the lead screw 108. The relative size of each gear may vary based on a desired gear reduction or amplification between the motor 106 and the lead screw 108, and the anticipated load being imparted on the gear.

[0106] The lead screw 108 may preferably include a threaded outer surface having a thread pitch and a thread direction. The lead screw 108 may be coupled to the gears 110, whereby rotation of the gears 110 may cause the threads of the lead screw 108 to impart a translation on the lead screw 108 along a length of the lead screw 108.

[0107] The motor 106, imparting a rotation on the lead screw 108, may control the position of the lead screw 108 by controlling a direction of rotation and rotational velocity of the lead screw 108. The plunger moving controllers 103 may send signals to the motor 106 to control the direction of travel and speed of plunger driver. The plunger moving controllers 103 may also control the lead screw 108 when it attaches to the plunger 202 and when the lead screw 108 is otherwise being moved or positioned within the interior of the infusion device 100. During an infusion procedure, the controller 112 may utilize inputs from the plunger moving controllers 103, or in other examples may only receive inputs from user controls and stored algorithms in a memory. For example, it may be desirable to control an infusion using a predefined infusion algorithm stored in the memory rather than allowing a user to control the speed at which fluid and treatment agent is administered. For example, certain treatment agents may require a particular infusion rate based on different variables. These variables may relate to characteristics of the user (e.g., height, weight, blood diagnostics, etc.), and they may relate to the type of fluid or treatment agent being infused. Therefore, it may be desirable to carefully control the infusion rate without allowing the user to interfere, for instance, by speeding up or slowing down an infusion. In this situation, a stored algorithm in the memory may be executed by the controller 112, whereby the controller 112 may carry out specific sequences by sending signals to plunger driver assembly to control the movement of the lead screw 108 and thus movement of syringe the plunger 202. The particular algorithm selected for an infusion and the variables serving as inputs for the algorithm may be loaded in various ways into the memory or provided to the controller 112. For instance, user controls and / or the user interface 102 may allow a user to manually input characteristics necessary to determine the infusion rate (e.g., by selecting the treatment agent to be infused, entering information about the user, etc.). The user interface 102 may prompt the user for necessary inputs and either the display itself (e.g., a touchscreen display) may be used or user controls may be utilized to respond to the prompts before the infusion begins. Alternatively, the infusion variables for the infusion algorithm may be preloaded or loaded using an alternative data transfer protocol that does not rely on manual input using the infusion device 100.

[0108] For instance, the infusion device 100 may include a serial interface, near-field communications (e.g., RFID, BlueTooth, Wi-Fi, etc.), or equivalent wired or wireless data transfer protocol for transferring information relating to algorithms that may be stored in the memory for execution by the controller 112. In some examples, the infusion device 100 may have an NFC reader capable of wirelessly reading the infusion variables or other information from a label or other description on a vial containing a fluid and / or a treatment agent. A third-party device, such as a smartphone or PC computer may also be used to prepare the algorithm and enter the necessary variables, after which the algorithm may be transferred to the infusion device 100 for execution by the controller 112. It is understood that a combination of inputs may be utilized to select and configure an infusion algorithm used to carry out the infusion. The algorithm may also operate completely independently of user input during execution (e.g., from input via the plunger moving controllers 103 or user controls), or the controller 112 may accept and process inputs from the user to alter, stop, or initiate the infusion algorithm.

[0109] For examples in which inputs may alter the infusion algorithm, user controls, such as buttons, switches, or a touchscreen interface, may be used to, among other things, increase the infusion rate, decrease the infusion rate, start the infusion, or cease the infusion. Alternatively, the inputs may be provided using the plunger moving controllers 103. During an infusion, the user may also receive feedback from the infusion device 100 in the form of visual, audible, and / or tactile responses. In one or more examples, the user interface 102 may provide the user with visual information about the infusion setup and its progress, or may provide any other indication necessary during, prior to, or after an infusion. For example, the user interface 102 may display images, icons, and / or text for providing instructions to the user regarding use of the infusion device 100. In addition, the user interface 102 may indicate a current status of the infusion or provide instructions for operating the plunger moving controllers 103 prior to, during, or after an infusion. Further still, these functions may be provided using an indicator, which may include an audible noise generator, a tactile feedback device such as a vibratory device, or equivalent device providing auditory or tactile feedback for a user.

[0110] Fig. 2 is a flow chart showing the procedure for changing an access code. Please note that the PUK code mentioned in the figure is identical to the unlock code mentioned in the claims and the PIN mentioned in the figure is identical to the access code mentioned in the claims. In the illustrated embodiment, the controller 112 of the infusion device 100 generates a 3-digit display code using a display code generating algorithm, which takes the actual time and the serial number of the infusion device 100 as input. The display code is displayed to the user of the infusion device 100, in this case an HCP, and is used as input for an unlock code generating algorithm. The 4- digit unlock code generated by the unlock code generating algorithm is not displayed to the user of the infusion device. The HCP communicates the generated display code to a support function along with the serial number of the infusion device 100. Using this information, the support function generates an unlock code using the same unlock code generating algorithm as the infusion device 100 so that the two independently generated unlock codes are identical. The support function returns the generated unlock code to the HCP, which can now use it for unlocking the infusion device 100 so that a new access code can be chosen. Should the HCP enter an incorrect unlock code, i.e. an unlock code not matching the one generated within the infusion device 100, five times in a row, a new display code is generated and displayed and the procedure starts from the beginning again.

[0111] Fig. 3 shows a display code generating algorithm, which generates a 3-digit display code from the actual time and the serial number of the infusion device 100. In the illustrated embodiment, the actual time and the serial number (both represented by 32 bits unsigned integers) are added to each other. Then the sum is logical shifted bitwise to the right three times, and the three last digits of the decimal number represented by the result of this shifting constitute the display code.

[0112] Fig. 4A is a flow chart showing the procedure for changing an access code according to an embodiment of the invention. In the illustrated embodiment, the infusion device 100 uses time and the infusion device serial number to generate a display code (2 1 7). The health care personal then calls a support line and communicates this display code to the support personnel. The support personnel looks in column 7 and row 21 of a table (shown in Fig. 4B) to determine a 4-digit unlock code (4 5 1 3) and communicates this unlock code to the health care personal, which can then use it for unlocking the controller 112 of the infusion device 100 to set a new access code.

[0113] The table referred to in the above description of Fig. 4A could look like the one shown in Fig. 4B. In the illustrated embodiment only 30 of which are illustrated, the table comprises 100 rows and 10 columns and provides a simple means to convert a 3-digit display code into a 4-digit unlock code by simply using the two first digits of the display code as a row index and the last digit of the display code as a column index for finding the cell in the table comprising the correct unlock code. In the shown example, display code 2 1 7 points to row 21 and column 7, in which the unlock code 4 5 1 3 is found.

[0114] Once the 1 ,000 different unlock codes for a given infusion device 100 has been found by running the unlock code generating algorithm for the given serial number and each of the 1 ,000 possible display codes, the use of such a table significantly reduces the complexity of the task put onto the support personnel when being asked to provide an unlock code for a given infusion device.

[0115] References used above include: infusion device 100; syringe opening in the infusion device 101 ; user interface 102; plunger moving controllers 103; plunger driver 104; drive train 105; motor 106; lead screw 108; gearing arrangement, gear 110; gear wheel 110a; planetary gear 110b; controller 112; orientation sensor 114; orientation sensor self-test system 115; battery 116; driver 117; current measuring sensor 118; receptacle 120; housing 122; housing top part 124; housing bottom part 126; hinge 128; syringe 200; plunger 202; driver end of the plunger 203; medicament compartment 204; medicament end of the plunger 205; movable seal 206; syringe outlet 208; infusion line 210; needle 212; needle outlet 214.

[0116] The user interface 102 is also denoted a display herein. The plunger moving controllers 103 are also denoted input elements herein. The display and the input elements are collectively also referred to as a user interface, III.

[0117] Fig. 5 shows a flowchart for a first method performed by the controller and enabling authorized resetting of an access code. At step 500 a display code, DC, is generated using a display code generating algorithm. Step 500 may be performed in response to detecting that the controller has entered a first state and / or that a first event is detected. At step 500, the first authorization may not be enabled. Step 500 may be reached from the point designated by capital ‘A’ (see fig. 6).

[0118] Step 500 receives a first value from a generator generating time-varying values, TVC, in step 501 , and a second value, SN, based on a serial number of the infusion device. The generator responds with the first value in response to a request for a time-varying value. The display code generating algorithm may generate the display code, DC, by combining the first value and the second value based on one or more of: multiplication, addition and subtraction, not including division; and bit-shifting. The display code is displayed in step 503 via a display at the user interface, III.

[0119] At step 502, the method generates an unlock code value, ULC, based on the display code value only, using an unlock code generating algorithm. The unlock code algorithm is configured to correspond with an implementation of the unlock code algorithm at a support facility, such that the unlock code generating algorithm at the controller and the support facility can generate identical pairs of display code values and unlock code values. The unlock code generating algorithm thus represents a shared secret at the controller and at the support facility. The unlock code value is not displayed via the display at the infusion device.

[0120] At step 504, via input elements 103, at the user interface receives a value input by the HCP or another person. The input elements 103 are also denoted

[0121] As described herein, the HCP obtains the third value via the support facility. At step 505 the method determines that the third value corresponds (Y) with the unlock code value, ULC, or fails to correspond (N) with the unlock code value, ULC. The ULC is stored in the controller.

[0122] In accordance with a determination, in step 505, that the third value corresponds with the unlock code value, the method proceeds via step 506 to enable access, via the user interface, to reset the access code and / or enabling the first authorization at least via step 508. The method may proceed from step 508 via point ‘C’. Correspondingly, in accordance with a determination, in step 505 that the third value fails to correspond with the unlock code value, the method proceeds via step 506 to forgo enabling access, via the user interface, to reset the access code and forgoes enabling the first authorization at least via step 507. The method may proceed from step 507 via point ‘B’ to resume at point ‘A’. As mentioned herein, the access code is also denoted a PIN code and the unlock code is also denoted a PUK code, e.g. a dynamic PUK code.

[0123] In continuation of the above-described authorized resetting of an access code, the below relates to obtaining authorization via the access code or initiating resetting of the access code.

[0124] Fig. 6 shows a flowchart for a second method performed by the controller and enabling authorized access at the infusion device and resetting of the access code. The second method arrives at point ‘A’ (cf. also fig. 5) in case authorization fails or at point ‘F’ in case authorization is successful. As mentioned, point ‘A’ leads to authorized resetting of an access code (cf. also fig. 5).

[0125] Point ‘F’ is reached via step 608 which provides access to the first function, which enables changing settings at the controller for controlling infusion, at the infusion device, in accordance with the settings. Via point ‘F’ the method may enable the controller to move the plunger driver in at least one direction without requiring authorization, via the user interface.

[0126] The second method starts however in point ‘E’ or in point ‘C’ (cf. fig. 5). Whereas point ‘E’ relates to getting access to the first function by inputting the access code value, point ‘C’ relates to inputting a new access code value following a reset (cf. fig. 5).

[0127] Point ‘E’ leads to step 601 and 603 wherein the method, via the display of the user interface, III, displays a prompt to enter an access code value. At step 604 a fourth value is received via the input elements of the user interface, III. At step 606 it is determined that the fourth value corresponds with or fails to correspond with a stored access code value, PIN. In accordance with a determination that the fourth value corresponds (Y) with the access code value, PIN, the method gives access via step 607 to the first function. As mentioned above, the first function enables changing settings at the controller for controlling infusion, at the infusion device, in accordance with the settings. Alternatively, in accordance with a determination that the fourth value fails to correspond (N) with the access code value, the method forgoes via step 607 enabling access to the first function. This is done by not enabling the first authorization to provide authorized access. In this situation, settings cannot be changed via the first function. Further, the method may further prevent the controller from moving the plunger driver in at least one direction at least until the access code is reset. In accordance with the determination that the fourth value fails to correspond (N) with the access code value, the method may proceed to step 609 to determine if a threshold number (N) of unsuccessful attempts to input the access code value is reached or exceeded. If the threshold is not reached or exceeded (N), the method may resume at step 604 to give the user another chance to input the access code. Alternatively, if the threshold is reached or exceeded (Y), the method may continue at step 610, which is described above.

[0128] Point ‘C’ leads to steps 602 and 603 wherein the wherein the method, via the display of the user interface, III, displays a prompt to enter a new (reset) access code value. At step 604 a fourth value is received via the input elements of the user interface, III. In this case the fourth value represent a new (reset) access code that is stored in step 605. The method may then proceed to point ‘E’.

[0129] The invention is further described in the following items.

[0130] 1 . An infusion device comprising: o a receptacle configured to receive a syringe, o a plunger driver configured to releasably engage an end of a plunger of the syringe, o a controller configured to generate signals controlling travel of the plunger driver in at least one direction, and o a user interface configured to allow a user, such as a health care person, to enter codes and to access and adjust settings of the controller after entering a valid access code, wherein the controller is configured to:

[0131] - generate a display code using a display code generating algorithm, which display code is displayed in the user interface, and

[0132] - generate an unlock code using an unlock code generating algorithm, which unlock code is not displayed in the user interface, whenever the valid access code must be reset or changed.

[0133] 2. The infusion device according to item 1 , wherein the display code generating algorithm generates the display code based on the present time and a serial number of the infusion device.

[0134] 3. The infusion device according to any of the preceding items, wherein the unlock code generating algorithm generates the unlock code based on the display code and the serial number of the infusion device.

[0135] 4. The infusion device according to any of the preceding items, wherein the display code consists of a number of characters, such as three, four or five characters. 5. The infusion device according to any of the preceding items, wherein the unlock code consists of a number of characters, such as four, five or six characters.

[0136] 6. The infusion device according to any of the preceding items, wherein the number of characters in the unlock code is different from the number of characters in the display code.

[0137] 7. The infusion device according to any of the preceding items, wherein the controller is configured to change the valid access code every time the access code has been used to access the controller of the infusion device.

[0138] 8. The infusion device according to any of items 1-6, wherein an access code is only valid until the next display code is generated by the display code generating algorithm or until the expiration of a limited period of time, such as two minutes, five minutes or ten minutes, calculated from the time of generation of the latest display code by the display code generating algorithm, whatever comes first.

[0139] 9. The infusion device according to item 8, wherein the generation of a display code by the display code generating algorithm and the generation of an unlock code by the unlock code generating algorithm is initiated by a user of the infusion device, for instance by pressing a button.

[0140] 10. The infusion device according to any of items 7-9, wherein the valid access code is identical to the latest unlock code generated by the unlock code generating algorithm.

[0141] 11 . The infusion device according to any of items 1-6, wherein the controller is configured to reset the valid access code if an incorrect access code has been entered a number of times, such as three times, four times or five times, since a valid access code was entered. The infusion device according to any of items 7-9 and 11 , wherein, when the valid access code has been reset, entering the unlock code generated by the unlock code generator allows the user to enter a new valid access code. The infusion device according to item 12, wherein the controller is configured to generate a new display code and a new unlock code if an incorrect unlock code is entered a number of times, such as three times, four times or five times. A method for controlling the access to a controller of an infusion device, which infusion device comprises: o a receptacle configured to receive a syringe, o a plunger driver configured to releasably engage an end of a plunger of the syringe, o a controller configured to generate signals controlling travel of the plunger driver in at least one direction and o a user interface configured to allow a user, such as a health care person, to enter codes and to access and adjust settings of the controller after entering a valid access code, wherein the controller is further configured to be able to reset or change the valid access code, which method comprises the steps of:

[0142] - generating a display code using a display code generating algorithm, which display code is displayed in the user interface of the infusion device, and

[0143] - generating an unlock code using an unlock code generating algorithm, which unlock code is not displayed in the user interface of the infusion device, whenever the valid access code must be reset or changed. 15. The method according to item 14, wherein the step of generating a display code generates the display code based on the present time and a serial number of the infusion device.

[0144] 16. The method according to item 14 or 15, wherein step of generating the unlock code generates the unlock code based on the display code and the serial number of the infusion device.

[0145] 17. The method according to any of items 14-16, wherein the step of generating the display code generates a display code consisting of a number of characters, such as three, four or five characters.

[0146] 18. The method according to any of items 14-17, wherein the step of generating the unlock code generates an unlock code consisting of a number of characters, such as four, five or six characters.

[0147] 19. The method according to any of items 14-18, wherein the number of characters in the generated unlock code is different from the number of characters in the generated display code.

[0148] 20. The method according to any of items 14-19, wherein the step of generating a display code and the step of generating an unlock code are performed every time a valid access code has been used to access the controller of the infusion device.

[0149] 21. The method according to any of items 14-19, wherein an access code is only valid until the next display code is generated by the display code generating algorithm or until the expiration of a limited period of time, such as two minutes, five minutes or ten minutes, calculated from the time of generation of the latest display code by the display code generating algorithm, whatever comes first. 22. The method according to item 21 , wherein the step of generating a display code and the step of generating an unlock code is initiated by a user of the infusion device, for instance by pressing a button.

[0150] 23. The method according to any of items 20-21 , wherein the step of generating a display code and the step of generating an unlock code are followed by a step of changing the valid access code to be identical to the unlock code generated in the step of generating an unlock code.

[0151] 24. The method according to any of items 14-19, wherein the step of generating a display code and the step of generating an unlock code are performed if an incorrect access code has been entered a number of times, such as three times, four times or five times, since a valid access code was entered.

[0152] 25. The method according to any of items 20-22 and 24, wherein the step of generating a display code and the step of generating an unlock code are followed by a step of enabling the user to enter a new valid access code, when the unlock code generated in the step of generating an unlock code has been entered.

[0153] 26. The method according to item 25, wherein the step of generating a display code, the step of generating an unlock code and the step of enabling the user to enter a new valid access code are repeated if an incorrect unlock code is entered a number of times, such as three times, four times or five times.

[0154] 27. The method according to any of items 14-26, wherein the method is performed by a controller of an infusion device according to any of items 1- 13.

[0155] Thus, the infusion device according to the first item allows for changing the access code, for instance, whenever it has been used. However, as only a display code, which is not identical to the new access code, is displayed to the user, the user needs to contact an authorised person, typically an HCP, in order to receive the unlock code, which may be identical to the new access code. Thus, the user can access the controller of the device, but only when he / she is supposed to do so, already being in contact with an HCP or another authorised person. Thus, the method according to the second item allows for changing the access code, for instance, whenever it has been used. However, as only a display code, which is not identical to the new access code, is displayed to the user, the user needs to contact an authorised person, typically an HCP, in order to receive the unlock code, which may be identical to the new access code. Thus, the user can access the controller of the device, but only when he / she is supposed to do so, already being in contact with an HCP or another authorised person.

Claims

CLAIMS1. A method at an infusion device, wherein the infusion device includes: a receptacle configured to receive a syringe; a plunger driver configured to releasably engage an end of a plunger of the syringe; a controller configured to control travel of the plunger driver in at least one direction; wherein the controller is configured with functions including a first function protected using first authorization that is enabled or not enabled to provide authorized access; and a user interface with a display and one or more input elements; the method comprising: in accordance with a determination that the first authorization, requiring an access code value, is not enabled: generating a display code value, based on a first value and a second value, using a display code generating algorithm; generating an unlock code value, based on the display code value only, using an unlock code generating algorithm; displaying the display code, via the display, and forgoing displaying the unlock code; receiving a third value, via the input elements, entered by a user; in accordance with a determination that the third value corresponds with the unlock code value, enabling access, via the user interface, to reset the access code and / or enabling the first authorization; in accordance with a determination that the third value fails to correspond with the unlock code value, forgoing enabling access, via the user interface, to reset the access code (PIN) and forgoing enabling the first authorization.

2. A method according to any preceding claim, comprising: in response to a detection that the first authorization is enabled to provide authorized access to the first function, enabling the controller to move the plunger driver in at least one direction without requiring authorization, via the user interface, including the access code value.

3. A method according to the preceding claim, comprising: receiving a fourth value, via the one or more input elements; in accordance with a determination that the fourth value corresponds with the access code value, enabling access to the first function; in accordance with a determination that the fourth value fails to correspond with the access code value, forgoing enabling access to the first function.

4. A method according to the preceding claim, comprising: in accordance with a determination that the fourth value fails to correspond with the access code value: forgoing enabling the controller to move the plunger driver in at least one direction and forgoing enabling the first function; and / or setting the first authorization to be not enabled.

5. A method according to any preceding claim, wherein the first function, protected using the first authorization, includes: receiving, via the input elements, one or more inputs corresponding with settings at the controller for controlling infusion, at the infusion device, in accordance with the settings.

6. A method according to the preceding claim, comprising: in accordance with reaching and / or exceeding a threshold number of consecutive determinations that the fourth value fails to correspond with the access code value, setting the first authorization, requiring the access code value, to be not enabled.

7. A method according to any preceding claim, comprising: in accordance with a determination that the third value fails to correspond with the unlock code value: generating the display code value anew based on the second value and based on obtaining the first value anew from the generator; and generating the unlock code value anew in response to the display code being generated anew.

8. A method according to any preceding claim, comprising: in accordance with a determination that the third value corresponds with the unlock code value, and in response to detecting a reset of the access code, enabling the first authorization.

9. A method according to any preceding claim, wherein the controller is configured to enter one or more states including a first state and / or to detect one or more events including a first event, comprising: detecting that the controller has entered the first state and / or that the first event is detected; and setting the first authorization, requiring an access code value, to be not enabled in response to detecting that the controller has entered the first state and / or that the first event is detected.

10. A method according to any preceding claim, wherein the controller includes a generator generating time-varying values; wherein the first value is obtained from the generator generating time-varying values including the first value; and wherein the second value is based on a serial number associated with the infusion device.

11. A method according to any preceding claim, wherein the display code generating algorithm combines the first value and the second value based on: one or more of: multiplication, addition and subtraction, not including division; and bit-shifting.

12. A method according to any preceding claim, wherein the time-varying values recurrently increment or decrement at a rate faster than once per 30 minutes, such as faster than once per minute, such as faster than or at once per second.

13. A method according to any preceding claim, wherein the time-varying values recurrently increment or decrement at a rate slower than once per 100 milliseconds, such as slower than or at once per second, such as slower than once per minute.

14. A method according to any preceding claim, wherein the display code value consists of a first number of characters; wherein the unlock code consists of a second number of characters; wherein the second number is different from the first number.

15. A method according to any of the preceding claims, wherein the infusion device is associated with a support facility; the method comprising: at the support facility: receiving a value corresponding with the display code; determining a code value identical to the unlock code value based on the value corresponding with the display code and an implementation of the unlock code generating algorithm; and delivering the third value to a user based on the code value identical to the unlock code value.

16. A method according to the preceding claim, wherein the support facility includes a call centre.

17. An infusion device, comprising: a receptacle configured to receive a syringe; a plunger driver configured to releasably engage an end of a plunger of the syringe; a controller configured to control travel of the plunger driver in at least one direction; wherein the controller is configured with functions including a firstfunction protected using first authorization that is enabled or not enabled to provide authorized access; and a user interface with a display and one or more input elements; wherein the infusion device is configured to execute the method according to any of claims 1-12.

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