Device for monitoring a drug pen using sensors

Abstract

The invention relates to a device designed to be coupled to a drug pen, the drug pen comprising a button and a rotary dose selector, wherein the monitoring device comprises: a) a processing unit; and b) one or more sensors configured to monitor one or more parameters related to the drug pen and / or to a drug contained in the drug pen. The processing unit is configured to process data received by the one or more sensors and to monitor the one or more parameters on the basis of the predetermined use of the drug pen.

Description

[0001] Drug Pen Monitoring Device with Sensors

[0002] Technical field of the invention

[0003] The present invention generally belongs to the field of medicine, and more specifically to the field of means designed to ensure adequate periodic application of a drug by chronic patients, such as the application of insulin in diabetic patients, in order to increase adherence to treatment and improve quality of life.

[0004] An object of the present invention is a device designed to be attached to a drug delivery pen of any type in order to monitor various parameters related to drug administration and delivery, so that the patient's treatment can be controlled by the patient or by caregivers, family members, or healthcare professionals. The device is configured to perform this monitoring transparently to the user, so that it does not imply any difference from the use of a non-monitored drug pen, thereby increasing adherence and improving the patient's quality of life.

[0005] Background of the invention

[0006] Diabetes mellitus comprises a range of metabolic disorders that cause chronically high blood glucose levels (hyperglycemia), primarily due to insufficient insulin secretion by the pancreas (type 1 diabetes) or high peripheral insulin resistance (type 2 diabetes). Currently, there are over 485 million people with diabetes worldwide. Insulin therapy is highly effective, so one of the biggest challenges is improving adherence to treatment to prevent severe complications from uncontrolled diabetes. This challenge exists in all chronic diseases.

[0007] Most diabetic patients are treated with regular insulin injections. A variety of devices are specifically designed for insulin injection, but in relation to the present invention, mention should be made of insulin injection pens. These pens are similar to writing pens, with a needle at one end and a button at the other to activate an insulin reservoir housed within the pen body. When the patient presses the button, a plunger pushes the cartridge, injecting a predetermined amount of insulin through the needle. Each cartridge stores enough insulin for several injections, for example, 300 units. When the cartridge is empty, it is discarded and replaced with a new, filled cartridge, or an insulin pen is replaced with a new, filled insulin pen.

[0008] Although these devices allow for easy and quick insulin injection, patients may forget the time of a previous injection, the amount of insulin injected, or whether a specific injection was actually administered. Consequently, patients, their parents or guardians (in the case of very young patients), or even healthcare professionals, lack certainty regarding the progress and data related to these injections. This poses a significant problem, as injecting the wrong amount of insulin can have potentially serious consequences for the patient.

[0009] The same problem arises with the injection of other drugs in chronic patients who require injections several times a day. Examples include growth hormone injections in short-statured individuals, GLP-1 therapy in type 2 diabetic patients, vitamin injections in individuals with iron deficiency, heparin injections to prevent venous thrombosis, and so on.

[0010] To solve this problem, there are devices that consist mainly of a drug application pen that has electronic means to control the injections.

[0011] However, these devices have disadvantages in that the electronic circuitry is embedded in the pen, preventing users from using the pen they are accustomed to. Furthermore, many of these devices are only useful to the patient who wears and uses them; they do not allow for real-time remote access to the information via external devices. Instead, the data is stored internally for later download through physical access to the device. This is important because third parties, such as parents, guardians, or doctors, may want to check this information using devices like tablets, smartphones, or computers.

[0012] Other devices can be added to various traditional drug pen systems, but they require additional handling. This alters the patient's workflow, leading to either incorrect injections or erroneous monitoring, including false positives (i.e., fictitious injections when the pen is accidentally activated). Furthermore, it hinders proper adherence to treatment, exacerbating the problem it is intended to solve. These issues are not limited to insulin in diabetic patients; they are common in other chronic diseases that utilize injection pens, such as multiple sclerosis, infertility, and obesity.

[0013] Therefore, there is a need for a device designed to be attached to a drug delivery pen of any type in order to monitor various parameters related to drug administration and application, without altering the process of using the drug pen to which it is attached.

[0014] Summary of the invention

[0015] The present invention relates to a monitoring device adapted for coupling to a drug pen, said pen comprising a push button and a rotary dose selector. The monitoring device comprises: (a) a processing unit, and (b) one or more sensors configured to monitor one or more parameters related to the drug pen and / or a drug contained in said drug pen. The processing unit is configured to process the data received by the one or more sensors and monitor the one or more parameters based on the predetermined use of the drug pen.

[0016] In a particular embodiment, the one or more sensors comprise a microphone suitable for recording ultrasound and the processing unit is configured to process the audio signal recorded by the microphone to select one or more audio samples in the ultrasound range indicative of one or more of the following: the number of drug units dispensed by the drug pen and / or the number of units selected on the rotary dose selector of the drug pen.

[0017] In a preferred embodiment, the processing unit is configured to process sounds above 25 kHz. In a more preferred embodiment, the processing unit is configured to process sounds of approximately 30 kHz.

[0018] In another preferred embodiment, the processing unit is configured to select one or more audio samples according to an algorithm of patch grouping, peak detection, zero removal, short sample removal, low amplitude removal, distance grouping and / or characterization and grouping.

[0019] In another preferred embodiment, the one or more sensors further comprise an orientation sensor, and the processing unit is further configured to process the one or more selected audio samples using the information recorded by the orientation sensor. In another particular embodiment, the one or more sensors comprise a capacitive sensor, and the processing unit is configured to process the capacitive field detected by the capacitive sensor to determine whether the user is using the drug pen by means of a capacitive threshold value, wherein when said capacitive threshold value is reached, the processing unit determines that the user is using the pen.

[0020] In a preferred embodiment, the processing unit is configured to process the capacitive field by setting a dynamic capacitive threshold value, wherein the dynamic capacitive threshold value is set to decrease slowly when the capacitive field value falls below the dynamic capacitive threshold value, and wherein the dynamic capacitive threshold value is set to increase rapidly to at least equal the capacitive field value once the capacitive field value exceeds the set threshold value.

[0021] In another particular embodiment, the monitoring device further comprises an external push button configured to activate the pen push button, wherein the push button comprises a rigid perimeter frame and a flexible outer layer.

[0022] In another particular embodiment, in which the one or more sensors further comprise an orientation sensor and a pulse sensor, the processing unit is configured to determine whether the drug pen is being purged or injected according to the orientation of the drug pen as determined by the orientation sensor when the pulse sensor detects that the button is pressed.

[0023] In a preferred embodiment, an orientation below 40° to 70° indicates that the Drug Pen 100 is being purged, and / or an orientation above 40° to 70° indicates that the Drug Pen 100 is being injected. The orientation is measured with respect to the vertical axis upwards, as determined by the orientation sensor.

[0024] In another particular embodiment, the one or more sensors further comprise a pulse sensor and a timer, and the processing unit is configured to process the pulse sensor and timer signals to determine whether the drug dose selected by the rotary dose selector has been administered correctly, wherein the orientation is measured with respect to the vertical axis upwards as determined by the orientation sensor.

[0025] In another particular embodiment, the pulse sensor is a mechanical switch. In another particular embodiment, the one or more sensors comprise a microphone suitable for recording ultrasound, a capacitive sensor, a push button, at least one orientation sensor, and a timer.

[0026] In a preferred embodiment, the microphone suitable for recording ultrasound is a microphone suitable for recording ultrasound according to any of the aforementioned embodiments, and / or the capacitive sensor is a capacitive sensor according to any of the aforementioned embodiments, and / or the push button is a push button according to any of the aforementioned embodiments, and / or the push button is a push button according to any of the aforementioned claims, and / or the orientation sensor is an orientation sensor according to any of the aforementioned embodiments, and / or the timer is a timer according to any of the aforementioned claims. Furthermore, the processing unit is a processing unit according to any of the aforementioned embodiments.

[0027] In another preferred embodiment, the microphone suitable for recording ultrasound is a microphone suitable for recording ultrasound according to any of the aforementioned embodiments, the capacitive sensor is a capacitive sensor according to any of the aforementioned embodiments, the push button is a push button according to any of the aforementioned claims, the orientation sensor is an orientation sensor according to any of the aforementioned embodiments, and the timer is a timer according to any of the aforementioned claims. Furthermore, the processing unit is a processing unit according to any of the aforementioned embodiments.

[0028] Brief description of the drawings

[0029] To allow for a better understanding of this disclosure, and to show how this disclosure may be carried out, reference will now be made, by way of example only, to the accompanying schematic drawings, in which:

[0030] Figure 1A shows an exploded view of a monitoring device according to one or more embodiments of the invention.

[0031] Figure 1B shows a perspective view of the monitoring device in Fig. 1A.

[0032] Figure 2A shows an exploded view of another monitoring device according to one or more embodiments of the invention. Figure 2B shows a perspective view of the monitoring device of Fig. 2A.

[0033] Figure 3 shows the mode of use of a monitoring device according to one or more embodiments of the invention, (A) before its coupling with a drug pen,

[0034] (B) after its coupling with a drug pen and before use of the drug pen and

[0035] (C) during use of the drug pen.

[0036] Figure 4 shows the mode of use of another monitoring device according to one or more embodiments of the invention, (A) before its coupling with a drug pen,

[0037] (B) after its coupling with a drug pen and before use of the drug pen and

[0038] (C) during use of the drug pen.

[0039] Figure 5 shows the mode of use of another monitoring device according to one or more embodiments of the invention, (A) before its coupling with a drug pen,

[0040] (B) after its coupling with a drug pen and before use of the drug pen and

[0041] (C) during use of the drug pen.

[0042] Figure 6 shows an exploded view of a toothed mechanism of a monitoring device according to one or more embodiments of the invention.

[0043] Figure 7A shows an example of raw data collected by a sensor according to one or more embodiments of the invention.

[0044] Figure 7B shows an example of the result of a patch grouping algorithm according to one or more embodiments of the invention.

[0045] Figure 7C shows an example of the result of a peak detection algorithm according to one or more embodiments of the invention.

[0046] Figure 7D shows an example of the result of a short sample elimination algorithm according to one or more embodiments of the invention.

[0047] Figure 7E shows an example of the result of a distance grouping algorithm according to one or more embodiments of the invention.

[0048] Figure 7F shows an example of the result of a characterization and grouping algorithm according to one or more embodiments of the invention.

[0049] Figure 8 shows a comparison between the probability of occurrence of the injection orientation angle and purging events according to an example of the present invention. Figure 9 shows a graph of the orientation angle of purging events according to an example of the present invention.

[0050] Figure 10 shows a graph of the probability of occurrence of the injection orientation angle according to an example of the present invention.

[0051] Figure 11 shows a graph of the variation of the capacitive field value according to the distance of an object to the capacitive sensor according to an example of the present invention.

[0052] Figure 12 shows a graph of the capacitive field value and dynamic capacitive threshold together with the activation state of the monitoring device according to an example of the present invention.

[0053] Description of the invention

[0054] Definitions

[0055] It should be noted that, as used herein, the singular forms "a," "an," "the," and "the" include plural references unless the context clearly indicates otherwise. Furthermore, unless otherwise stated, the expression "at least" preceding a series of items shall be understood to refer to all items in the series. Those skilled in the art will recognize, or be able to determine using nothing but routine experimentation, many equivalents to the specific embodiments of the invention described herein. Such equivalents are intended to be covered by the present invention.

[0056] It should be noted that the term "approximately", as used herein, refers to + / - 30%, preferably + / - 20%, preferably + / - 15%, more preferably + / - 10%, of the stated value to which reference is made.

[0057] As used herein, the conjunction "and / or" between multiple recited elements is understood to encompass both individual and combined options. For example, when two elements are joined by "and / or," a first option refers to the applicability of the first element without the second. A second option refers to the applicability of the second element without the first. A third option refers to the joint applicability of the first and second elements. Any one of these options is understood to be included within the meaning and thus satisfy the requirement of the term "and / or" as used herein. It is also understood that the concurrent applicability of more than one of the options is included within the meaning and thus satisfies the requirement of the term "and / or."

[0058] Throughout this specification and the claims that follow, unless the context otherwise requires, the word "comprises," and variations such as "comprising" and "comprising," shall be understood to imply the inclusion of an integer or step or group of integers or steps, but not the exclusion of any other integer or step or group of integers or steps. When used herein, the term "comprises" may be substituted for the term "contains" or "includes," or, sometimes, when used herein, for the term "having." Any of the foregoing terms (comprising, containing, including, having), whenever used herein in the context of an aspect or embodiment of the present invention, may be substituted for the term "consisting of," although less preferred.

[0059] When used herein, "consisting of" excludes any element, step, or ingredient not specified in the claim. When used herein, "consisting essentially of" does not exclude materials or steps that do not materially affect the basic and novel characteristics of the claim.

[0060] Description

[0061] Each embodiment disclosed herein is deemed applicable to each of the other disclosed embodiments. Therefore, all combinations of the various elements described herein are within the scope of the invention. It should also be understood that, unless clearly stated otherwise, in any method claimed herein that includes more than one step or act, the order of the steps or acts of the method is not necessarily limited to the order in which the steps or acts of the method are recited.

[0062] The present invention solves at least the problem of monitoring various parameters related to the administration and application of drugs, without interfering with the process of using the drug pen to which it is attached.

[0063] For this purpose, a monitoring device 1 adapted for coupling to a drug pen 100 is described as an example in Figs. 1A and 1B and 2A and 2B, said pen 100 comprising a push button 101 and a rotary dose selector 104.

[0064] The monitoring device 1 can be adapted to attach to the drug pen 100 in various ways depending on specific needs. A preferred arrangement involves axial attachment to the drug pen. When attached axially, it comprises a coupling section 7, including a cavity or opening that allows it to enclose part of the drug pen 100, preferably the push button 101 and the rotary dose selector 104.

[0065] Pushbutton 101 and rotary dose selector 104 allow the user to control the delivery of a drug from the drug pen 100.

[0066] To do this, the user presses the button (101) located on the back of the pen body (100), which in turn activates an internal plunger that releases insulin through a needle at the opposite end of the cartridge. Before pressing the button, the user rotates the rotary dose selector (104) to select the desired dose.

[0067] The monitoring device 1 comprises: a) a processing unit 2, and b) one or more sensors 3. The processing unit 2 may comprise one or more processing units, such as a microprocessor, GPU, CPU, multi-core processor, or the like. Therefore, the processing unit is not to be understood as a single element or limited by the number of processors. Similarly, the device 1 may further comprise a memory unit, and the memory unit may comprise one or more volatile or non-volatile memory devices, such as DRAM, SRAM, flash memory, read-only memory, ferroelectric RAM, hard disk drives, floppy disks, magnetic tapes, optical discs, or the like.

[0068] The one or more sensors 3 are configured to monitor one or more parameters related to the drug pen 100 or to a drug contained in said drug pen 100. The one or more sensors may be of various types, each intended to measure specific parameters. Examples of sensor types include: pressure sensors, temperature sensors, sound sensors, capacitive sensors, pulse sensors, vibration sensors, accelerometers, and gyroscopes, among others. The present invention is not limited as to the number or type of sensors that the one or more sensors 3 may comprise.

[0069] Each sensor 3 can be configured to measure one or more relevant parameters, as described in later embodiments. Furthermore, two or more sensors can work together to measure the same parameter, improving measurement accuracy. This collaboration between sensors ensures more reliable and detailed results and benefits from a synergistic effect by allowing the measurement of parameters that none of them can reliably measure on their own. The processing unit 2 is configured to process the data received from the one or more sensors 3 and monitor the one or more parameters based on the default use of the drug pen 100.

[0070] The monitoring device 1 is adapted for attachment to a pen comprising, as previously mentioned, a push button 101 and a rotary dose selector 104. Through the process described above, the user can control the pen's operation and determine the amount of medication to administer and when. The process may vary slightly between pens, for example, due to different usage recommendations regarding injection sites, or internal mechanisms with additional functionalities, such as dose correction or prevention of loading doses exceeding the available capacity of the pen or cartridge. Thus, each pen has a predetermined method of use established by the manufacturer, which the user must follow and become accustomed to in order to ensure successful injection.

[0071] To prevent the injection of air bubbles, it is quite common to need to prime pens on their first use, as well as after a long period of disuse, to ensure the needle is completely clear. It is generally recommended to prime pens before any injection. In some cases, the term "priming" is used instead of "priming."

[0072] Thanks to one or more sensors, the processing unit 2 can monitor one or more parameters of the pen without being affected by different scenarios. The use of one or more sensors allows for the detection of different states or events and the monitoring of one or more parameters related to the drug pen 100 or the drug contained in said drug pen 100, based on the predefined use of the drug pen (100), which the user has already become familiar with.

[0073] Advantageously, this allows monitoring of treatment adherence without the monitoring device 1 needing any modification of the drug pen usage process to which it is attached, such as use at certain angles, prior pulses to activate device 1, or waiting for certain time intervals for device 1 to detect a specific event.

[0074] The following details various embodiments of the present invention relating to one or more sensors 3 and the configuration of the processing unit 2, which allows the monitoring device 1 to operate without any modification to the procedure for using the drug pen to which it is attached. It should be noted that Figures 1A, 1B, 2A, and 2B show a monitoring device according to the present invention comprising, in addition to a processing unit 2 and one or more sensors 3, as shown in exploded views 1A and 2A, several other elements such as an external push button 4, a coupling section 7, a battery 6, and an additional housing 5, which are not necessarily present in other embodiments of the invention, or which may be present in different forms, shapes, arrangements, or numbers.Thus, the external push button 4, while present in many monitoring systems, may be absent in some embodiments, where the entire monitoring device moves and acts as a piston, transferring the applied pressure to the push button 101 of the drug pen 100. It is also noted that the shape of the coupling section 7 may differ depending on the drug pen 100 for which device 1 is designed, or may not exist in other embodiments of the present invention. Furthermore, the charging port may be absent, and, for example, another charging mechanism, such as wireless charging, may be used. Therefore, the present invention is not limited by any of the aforementioned elements, nor by the specific features of the monitoring device 1 shown in the figures.

[0075] Furthermore, as shown in Figs. 3 and 4, the monitoring device 1 is not limited to a particular connection mechanism with the drug pen 100 or by the way the pen operates, provided that it contains a push button 101 and a rotary dose selector 104.

[0076] Thus, the drug pen 100 may comprise a separate push button 101 and rotary dose selector 104, or a single element may serve as both push button 101 and rotary dose selector 104. In the latter case, the push button 101 will rotate during the loading of the drug dose, pre-charging a spring, but not during its unloading after pressing the push button 101, at which point the spring is released. To achieve this, the monitoring device 1 may be adapted with various solutions that allow for this rotation without compromising the ergonomics of the drug pen 100 for the user.

[0077] For example, in Fig. 3, a monitoring device 1 according to the present invention is shown, wherein the drug pen 100 comprises an independent push button 101 and rotary dose selector 104. The monitoring device 1 is adapted for coupling to said drug pen, such that the monitoring device 1 comprises a coupling section 7 configured to be externally positioned on the rotary dose selector 104, external to the rest of the monitoring device 1. Thus, as shown in Fig. 3B, when the external push button 4 is not pressed and therefore the push button 101 of the drug pen 100 is not pressed, the coupling section 7 is rotationally fixed with the rest of the monitoring device 1, so that the user can select the drug dose by rotating the monitoring device 1.After pressing button 4, button 101 on the drug pen 100 is simultaneously pressed, initiating the injection. This releases a clutch mechanism associated with coupling section 7, allowing it to rotate freely relative to the rest of the monitoring device 1. Thus, coupling section 7 rotates along with the rotary dose selector 104, and because it is rotationally free from the rest of the monitoring device 1, the only part of the monitoring device 1 that rotates during discharge is coupling section 7. This allows for an ergonomic grip without impeding the free rotation of the rotary dose selector 104 during discharge.

[0078] In Fig. 4, a monitoring device 1 according to the present invention is shown, in which the drug pen 100 comprises a single element that serves as both a push button 101 and a rotary dose selector 104. This allows the user to transmit a rotation for loading the units to be injected before the injection. The monitoring device 1 is adapted for coupling to said drug pen, such that the monitoring device 1 comprises a coupling section 7 configured to be arranged externally on the rotary dose selector, but internally within the rest of the monitoring device 1. Thus, as shown in Fig.4B, when the external push button 4 is not pressed and therefore the push button 101 of the drug pen 100 is not pressed, the coupling section 7 is rotationally fixed with the rest of the monitoring device 1, so the user can select the drug dose by rotating the monitoring device 1. After the push button 4 is pressed, the push button 101 of the drug pen 100 is in turn pressed, initiating the injection. In the process of transferring the movement from the external push button 4 to the push button 101, as shown in Fig. 4C, the rotary dose selector 104 of the drug pen 100 is set to disengage, not rotating back to the initial position, while internally a mechanism rotates, releasing the drug.This allows the rotary dose selector 104 to rotate relative to the internal parts that transmit pressure to the drug reservoir for expulsion, and in this way, during injection, the rotary dose selector 104 and the coupling section 7 remain fixed next to the monitoring device relative to the user's hand.

[0079] Figure 5 shows a monitoring device 1 according to the present invention, wherein the drug pen 100 comprises a push button 101 and a rotary dose selector 104 independent of each other. The monitoring device 1 is adapted for coupling to said drug pen, such that the monitoring device 1 comprises a coupling section 7 configured to be externally positioned on the rotary dose selector, external to the rest of the monitoring device 1. Thus, as shown in Figure 5B, when the external push button 4 is not pressed and therefore the push button 101 of the drug pen 100 is not pressed, the coupling section 7 is rotationally fixed with the rest of the monitoring device 1, so that the user can select the drug dose by rotating the monitoring device 1.After pressing button 4, the button 101 of the drug pen 100 is also pressed, initiating the injection. In the process of transferring the movement from the external button 4 to button 101, as shown in Fig. 5C, the coupling section 7 becomes rotationally free with respect to the rest of the monitoring device 1. Therefore, the rotary dose selector 104 and the coupling section 7 can rotate while the drug pen 100 and the monitoring device 1 remain fixed relative to the user's hand. A clutch mechanism is used to make the coupling section 7 rotationally free. Figs. 5B and 5C show a clutch mechanism consisting of a compressible spring 8 and a toothed mechanism 9.When spring 8 is compressed, the toothed mechanism 9 is released, allowing relative rotation of the coupling section 7 with respect to the rest of the monitoring device, along with the rotary dose selector 104. However, the clutch mechanism can have various alternative configurations. For example, the compressible spring 8 can be replaced by a magnetic system with at least two opposing magnets of the same polarity, such that they repel each other. This creates a system where the magnetic system is capable of performing a function equivalent to that of spring 8. Another alternative to the clutch mechanism is the use of an elastic plastic material. Those skilled in the art can visualize various alternatives to the solutions presented here with the same functionality, all of which are found within the present embodiment.

[0080] The toothed mechanism 9 allows the clutch mechanism to change the relative rotation between the coupling section 7 and the rest of the monitoring device. For example, the toothed mechanism 9 may consist of two opposing toothed rings 9a and 9b, such that when both rings 9a and 9b are in contact, they prevent relative rotation between them, and when they separate, relative rotation between them is permitted. For example, as shown in Fig. 6, one toothed wheel 9a may be associated with the coupling section 7 and the other with the rest of the monitoring device via the additional housing 5. It should be noted that the toothed mechanism 9 may include a rotation encoder which, by means of a sensor in said encoder, allows the relative rotation between the coupling section 7 and the rest of the monitoring device to be determined. As with Figures 1A, 1B, 2A, and 2B, it should be noted that Figs.Figures 3 and 4 show a monitoring device according to the present invention comprising various elements such as an external push button 4, a coupling section 7, and an additional housing 5, which need not be found in other embodiments of the invention, or which could be found in different ways, shapes, arrangements, or numbers. For example, the coupling section 7 and the housing 5 could be the same element and could form part of the same piece comprising the external push button 4.

[0081] In a particular embodiment of the present invention, the one or more sensors (3) comprise a microphone suitable for recording ultrasound. A microphone suitable for recording ultrasound is a device designed to capture, among other things, sound frequencies that are beyond the range audible to the human ear, i.e., ultrasonic frequencies. These frequencies are typically in the range of 20 kHz or higher. However, the microphone can also capture other frequencies, such as the audible range between 20 Hz and 20 kHz.

[0082] Microphones suitable for recording ultrasound can be manufactured using various technologies and materials. Common methods include piezoelectric, which uses piezoelectric crystals that generate an electric current in response to ultrasonic vibrations; and electromagnetic, which employs a moving coil within a magnetic field to generate an electric current in response to ultrasonic vibrations. In this respect, the appropriate microphone for recording ultrasound is not limited to any particular technology.

[0083] Furthermore, the monitoring device 1 may include an opening in its design. This opening allows ultrasonic waves to more easily enter the monitoring device 1 and reach the microphone, thereby improving the device's wave pickup capability.

[0084] In this particular embodiment, processing unit 2 is configured to process the audio signal recorded by the microphone to select one or more audio samples in the ultrasound range. This means that processing unit 2 is configured to select, from all the data continuously collected by the microphone, the most relevant samples for further processing. This allows for efficient use of the memory of monitoring device 1.

[0085] Processing unit 2 can select one or more audio samples indicative of one or more of the following events or actions: the number of drug units dispensed by drug pen 100, and / or the number of units selected on the rotary dose selector 104 of drug pen 100.

[0086] When the medication is dispensed by injection, the pens generate a mechanical sound imperceptible to the user, which indicates the number of medication units dispensed by the 100-unit pen. This sound includes several characteristic frequencies, including those in the ultrasound range. Therefore, using a microphone designed to record ultrasound, among other frequencies, the amount of medication injected by the user can be determined.

[0087] When loading the injection units using the rotary dose selector 104, the pens generate a mechanical sound that indicates the loaded dose. This allows the user to determine not only the amount of drug injected but also the number of corrections made, which can help identify problems with device use and provide usage advice.

[0088] By measuring the duration of the sound during drug dispensing, the duration of the injection can be determined, which can help detect false injections, such as empty discharges.

[0089] These events or parameters can be measured simultaneously.

[0090] In a preferred embodiment, processing unit 2 is configured to process sounds above 25 kHz. To achieve this, processing unit 2 can be configured in various ways, such as focusing all its resources on capturing all the information obtained at such high frequencies and then storing that information for later processing. Given the size of these devices and their processing, storage, and power limitations, this configuration requires precise resource management to work with the data correctly.

[0091] It should be noted that this configuration should not be considered exclusive, as the microphone can also capture other frequencies, such as the audible range, and processing unit 2 can also be configured to process these other frequencies. Therefore, it should be understood that the processing unit is configured to process at least sounds above 25 kHz, but that it can also process sounds equal to or below 25 kHz.

[0092] In a preferred embodiment, processing unit 2 is configured to process sounds of approximately 30 kHz. As before, this requires precise resource management to work with the data as desired. Advantageously, this allows for the clear capture of sounds emitted by the drug pen 100 in its various mechanisms, by the drug contained within it, and by the monitoring device 1, which are typically in these ranges inaudible to the user.

[0093] In another preferred embodiment, processing unit 2 is configured to select one or more audio samples according to an algorithm of patch grouping, peak detection, zero removal, short sample removal, low amplitude removal, distance grouping and / or characterization and grouping.

[0094] The microphone collects raw data. In this context, "raw data" refers to the initial, unaltered readings or observations obtained directly from the source, without any manipulation, filtering, or transformation. These raw measurements serve as the basis for subsequent analysis, processing, or interpretation. The term is commonly used in various fields, including scientific research, engineering, and data science, where capturing accurate, unadulterated data is essential for generating meaningful information and drawing valid conclusions. Raw data measurements provide the most authentic representation of observed phenomena, capturing the inherent variability and characteristics of the signals or information about how they are measured. An example of raw sound pressure data over time can be seen in Fig. 7A.

[0095] Through various algorithms, processing unit 2 can perform sample selection. The "patch clustering algorithm" involves first detecting peaks in a dataset and then grouping data points around each peak into clusters. Clustering methods are then applied to categorize these patches, enabling specific analyses tailored to each cluster, such as feature extraction, statistical analysis, or anomaly detection. This approach facilitates a nuanced understanding of the unique characteristics associated with individual peaks in the data, allowing for more specific and detailed insights. For example, each measured sound patch might have 240 measurements, which begin when a certain sound level threshold is exceeded, but the maximum is not checked anywhere within those 240 measurements. There might be, for example, three such "patches" in a row.The patch grouping algorithm is configured to find the peak of the sound and keep the surrounding audio segment, taking segments from the corresponding patch audio recordings. An example of the result of a patch grouping algorithm can be seen in Fig. 7B, where some of the preceding sound has been removed. However, in other implementations, it can be configured to remove different proportions of sound before and after the peak.

[0096] Distinguishing distinct peaks in a dataset typically involves using signal processing or data analysis techniques to identify and separate the distinct high points. Common methods include peak detection algorithms, such as searching for local maxima or applying filters to accentuate peaks. Clustering techniques can also be used to group data points around each peak. In addition, features such as peak width, amplitude, and separation can be extracted to characterize and differentiate the identified peaks. The goal is to improve the accuracy of peak identification and enable more nuanced analysis of complex datasets with distinct peaks. An example of the output of a peak detection algorithm can be seen in Fig. 7C.

[0097] Zero removal from patches typically refers to the process of eliminating or filtering out data points with a value of zero within specific patches or clusters of a dataset. These zero values ​​correspond to signal outliers, such as those resulting from interference, connectivity failures, or any other error that prevents measurement. This step is performed during data preprocessing or analysis to improve the accuracy of subsequent computational or static measurements. Zero removal can be relevant in situations where zero values ​​could introduce bias or unwanted effects, especially in cases involving reference values, averages, or other mathematical operations where division by zero might occur.Removing zero values ​​from patches is intended to refine the dataset, ensuring that subsequent analyses focus on non-zero data points, which can be especially important in certain contexts, such as signal processing, image analysis, or any domain where zero values ​​may distort the intended interpretation of the data.

[0098] Patch filtering, which removes small samples (e.g., fewer than 40 data points), typically involves a process where patches or clusters within a dataset are retained only if they contain a sufficient number of data points, such as 40 or more. This type of filtering is often used during data analysis or preprocessing to focus on patches that contain a significant amount of information or to reach a minimum threshold for robust analysis. By excluding patches with fewer than a certain number of data points, analysts can ensure that subsequent calculations or statistical measures are based on more reliable measures and substantial datasets, thus reducing the impact of noise or outliers. An example of the result of a short-sample removal algorithm can be seen in Fig. 7D.

[0099] Patch filtering, where peak amplitudes fall below a certain threshold, involves a data processing step in which patches or clusters containing peaks with amplitudes below a specified threshold are excluded or filtered out. This type of filtering is applied in signal processing or data analysis to focus on significant peaks or events that exceed a certain intensity or magnitude. By setting a specific minimum threshold for peak amplitudes, you ensure that only patches containing peaks with amplitudes greater than or equal to the specified threshold—for example, 8 units—are retained. This can eliminate input noise or less significant peaks from the analysis. This approach is useful in various applications, such as identifying important features in signal data or identifying relevant events in datasets where peak amplitudes play a crucial role.

[0100] The process of grouping and ordering patches with minimum separation involves organizing patches in a dataset based on a specified minimum distance criterion. Patches are grouped according to certain characteristics, and an algorithm is applied to arrange them in a specific order while ensuring that the minimum separation requirement is met. This approach is common in temporal or spatial data analysis because it provides a structured way to organize and analyze patches while maintaining a defined minimum distance between them, which is crucial for various applications such as image processing or the analysis of temporal events. An example of the result of a distance-based grouping algorithm can be seen in Fig. 7E.

[0101] Characterization and clustering with minimum and maximum values ​​involve processes in which data are organized and grouped based on specified minimum and maximum criteria. The term "characterization" preferably refers to the identification or extraction of relevant features or factors within the dataset, while the term "clustering" preferably refers to the grouping of data points with similar characteristics. The inclusion of minimum and maximum values ​​means that data points falling within predefined ranges are considered for characterization or clustering. Determining minimum and maximum values ​​plays a crucial role in refining the dataset and adapting analyses to different ranges of interest, contributing to a more nuanced understanding of the underlying parameters or characteristics of the data.An example of the result of a characterization and grouping algorithm can be seen in Fig. 7F. In another more preferred embodiment, processing unit 2 is configured to select one or more audio samples according to a patch grouping algorithm, a peak detection algorithm, a zero removal algorithm, a short sample removal algorithm, a low amplitude removal algorithm, a distance grouping algorithm, and a characterization and grouping algorithm.

[0102] Advantageously, the recorded sound information contains the minimum but essential information to detect the quantity of drug units dispensed by the drug pen (100), the quantity of units selected on the rotary dose selector (104) of the drug pen (100).

[0103] These signals can then be analyzed by an external device, preferably one with access to a database and classification software capable of classifying them.

[0104] Furthermore, it is worth noting that processing unit 2 can be configured to implement any of the aforementioned algorithms: patch grouping, peak detection, zero removal, short sample removal, low amplitude removal, distance grouping, and / or characterization and grouping. These algorithms can be implemented independently or in combination in any of the possible ways, using various programming techniques. Thus, it can be implemented through programming using classical signal processing or neural networks, capable of generating one or more of the previously described effects on an input signal to obtain the output signal. Experts in this field are familiar with different types of algorithms in the machine learning environment, both supervised and unsupervised, capable of implementing the algorithms described above.All these different implementation alternatives are also encompassed in the invention.

[0105] This allows combining a monitoring device 1 that does not require any modification of the use already predetermined by the pen with comprehensive monitoring of adherence to treatment and the use given to the drug pen, effectively allowing to increase adherence without adding technological or usage barriers.

[0106] In another preferred embodiment, the one or more sensors 3 further comprise an orientation sensor, and the processing unit 2 is further configured to process the selected audio samples using the information recorded by the orientation sensor. Thus, the samples indicate the number of drug units dispensed by the drug pen 100 and / or the number of units selected on the rotary dose selector 104 of the drug pen 100. The orientation sensor can be, for example, a gyroscope or any other type of sensor that can at least determine its orientation, such as an IMU. The orientation sensor allows discrimination as to whether two peaks very close together in the audio sample are a single peak or two very close peaks (if the rotation is very rapid).Occasionally, if the user selects a very rapid loading process, the peaks are so close together that before the reverberation / resonance of the sound-emitting components or the processes that give the sound its duration has even subsided, the amplitude of the next peak is already rising. Sometimes the peak fluctuations themselves have shapes similar to two peaks very close together, or when there are many peaks very close together, it is difficult to distinguish them from one another or determine how many there are. This helps us determine whether the peak is an additional unit loading, a correction, or a unit deselection (-1 unit). Since in some models of the 100-drug pen the rotation sounds during loading and unloading are indistinguishable or barely distinguishable, the orientation sensor helps to differentiate between loading and correction.

[0107] In another particular embodiment, the one or more sensors 3 comprise a capacitive sensor. A capacitive sensor is a type of sensor that measures changes in electrical capacitance to detect the presence or changes in the position of a nearby object. Capacitance refers to the ability to store electrical charge. The capacitive sensor detects the variation in capacitance between two conductive plates, one of which may be the sensor surface and the other the object or nearby environment. When an object approaches or touches the sensor, it alters the capacitance, and this change is thus detected.

[0108] In this embodiment, the processing unit 2 is configured to process the capacitive field detected by the capacitive sensor to determine whether the user is using the drug pen 100 by means of a capacitive threshold value, wherein when said capacitive threshold value is reached, the processing unit 2 determines that the user is using the pen.

[0109] By measuring the ambient capacitance, it can be determined whether a user is holding monitoring device 1. This allows for the establishment of a capacitance threshold that indicates the user is holding monitoring device 1.

[0110] Advantageously, this allows us to know when the user is going to use the device and when not, without needing to interact with it in a different way than they would if they were directly using the 100 drug pen.

[0111] In a preferred embodiment, the capacitive sensor is integrated into a flexible PCB strip. This allows for various configurations. For example, the capacitive sensor can take the form of a band surrounding all the electronics, such as the processing unit 2 and / or the one or more sensors 3 and / or the battery 6. In another example, the capacitive sensor includes this band and further comprises a wafer perpendicular to it, preferably external to the battery 6. This enables the detection of a user's hand grasping the device by the coupling section 7 of the monitoring device shown in Figure 3. In the various embodiments, the capacitive sensor is preferably configured to be sensitive in directions opposite to those in which the electronics are located, so that the capacitive sensor is primarily affected by the user's hand grasping the device.

[0112] Typically, users want to be able to turn off medication pen monitoring devices, as they are used sporadically throughout the day and are expected to have a compact size and weight with a long battery life. This is usually achieved through push-button or switch-based mechanisms, requiring the user to turn on the monitoring device before use.

[0113] In this particular implementation, it is possible to determine at any time whether the user is holding the device or not, that is, whether they wish to use it or not. An extreme power-saving mode can be set for situations where the device is not in use. Therefore, simply picking up the pen with the attached monitoring device 1 will automatically turn it on and configure it for a new monitoring session.

[0114] In a preferred embodiment, processing unit 2 is configured to process the capacitive field by setting a dynamic capacitive threshold value.

[0115] The capacitive field measures the electrical capacitance of the capacitive sensor. While the capacitive field is usually measured in Farads, in this embodiment, any type of signal, regardless of its units, that is capable of representing the electrical capacitance of the capacitive sensor is understood to be included. Thus, depending on the signal used, it can be established that the value of the capacitive field of the capacitive sensor increases when an object approaches, for example, a user's hand, and decreases when the object moves away, or that the value of the capacitive field of the capacitive sensor decreases when an object approaches and increases when the object moves away. From now on, the operation of the dynamic capacitive threshold will be described according to the second alternative, in which the value of the capacitive field of the capacitive sensor decreases when an object approaches and increases when it moves away, as can be seen in Fig. 11.However, those skilled in the art know that if the capacitive field value is measured in such a way that it increases as an object approaches and decreases as it moves away, the same technical effect can be achieved by reversing the operation of the dynamic capacitive threshold. The capacitive threshold value is defined as a value that allows one to determine whether or not the user is holding the monitoring device. In the present embodiment, the capacitive threshold value is a dynamic capacitive threshold value, since the capacitive threshold changes over time. This is necessary because the capacitive field value fluctuates with time and the environment, making it impossible to establish a fixed capacitive threshold value.

[0116] In the present embodiment, the dynamic capacitive threshold value is configured to decrease slowly when the capacitive field value falls below the dynamic capacitive threshold value, and the dynamic capacitive threshold value is configured to increase rapidly to at least equal the capacitive field value once the capacitive field value exceeds the set threshold value.

[0117] It should be noted that the terms “slowly” and “rapidly” are preferably defined as follows. The dynamic capacitive threshold value is set to decrease slowly, such that, in the use case, it takes a time T1 to reach the capacitive field value. The dynamic capacitive threshold value is set to increase rapidly, such that, in the use case, it takes at most a few seconds to reach the capacitive field value. It should be emphasized that a subject matter expert is able to calculate and program the rate of change of the dynamic capacitive threshold value according to their use case and the time T1 they determine, as explained below.

[0118] Thus, it is determined that a significant difference between the capacitive field value and the dynamic capacitive threshold value is indicative that the user has interacted with the monitoring device 1. This allows the monitoring device to enter a high activity mode by initiating the various sensors and monitoring the drug pen 100.

[0119] As shown in Fig. 12, once the user interacts with monitoring device 1 by bringing their hand near it, the capacitive field value decreases rapidly. However, the dynamic capacitive threshold value is set to decrease slowly, creating a significant difference (d1) between the capacitive field value and the dynamic capacitive threshold value. Therefore, this significant difference can be considered indicative of user interaction with monitoring device 1, thus activating it. This significant difference can be defined as a value between 2% and 20%. In a preferred embodiment, a difference between 2% and 15% indicates user interaction with monitoring device 1.In a more preferred embodiment, a difference between 5% and 10% is indicative that the user has interacted with monitoring device 1. More preferably, a difference of 5% is indicative that the user has interacted with monitoring device 1.

[0120] It is also determined that once the difference between the capacitive field value and the dynamic capacitive threshold value is no longer significant for a set period of time T2, it indicates that the user is no longer interacting with the monitoring device 1. This allows the monitoring device to enter a sleep or low-power mode, which increases battery life without increasing size or weight. This solution allows for usage times of approximately two weeks before a recharge or battery replacement.

[0121] This non-significant difference (d2) can be set as a value less than between 2% and 20%. In a more preferred embodiment, it can be set as a value less than between 2% and 15%. In a more preferred embodiment, it can be set as a value less than between 5% and 10%. More preferably, it can be set as a difference less than 5%.

[0122] The set time T2 during which the difference between the capacitive field value and the dynamic capacitive threshold value is not significant enough to determine that the user is no longer interacting with the monitoring device 1 is between 2 and 30 seconds. More preferably, the set time T2 is between 5 and 15 seconds, even more preferably around 5 seconds.

[0123] As shown in Fig. 12, while the user interacts with the monitoring device, the dynamic capacitive threshold value decreases until it reaches the capacitive field value. This signal decay can be adjusted in various ways, such as linear, exponential, or logarithmic. In a preferred embodiment, the decay is exponential. Furthermore, the time T1 that the dynamic capacitive threshold value takes to reach the capacitive field value can be controlled. In a preferred embodiment, this T1 value is between 1 and 5 minutes.Advantageously, this allows the monitoring device to remain powered on for a reasonable amount of time, as it delays the point at which the difference between the capacitive field value and the dynamic capacitive threshold value becomes insignificant, thus delaying the start of the T2 time count. This ensures that even if the user takes a long time to perform the injection, the monitoring device remains powered on for at least T1 + T2, preventing it from missing any injections. This avoids false negatives. In the context of this invention, the term "false negative" refers to an injection not detected by the monitoring device.

[0124] Finally, as shown in Fig. 12, once the user stops interacting with the injection pen 100 and the monitoring device 1, the capacitive field value increases rapidly. The dynamic capacitive threshold value is set to increase rapidly until it at least equals the capacitive field value, so the difference between the capacitive field value and the dynamic capacitive threshold value is not significant. It can be seen that the dynamic capacitive threshold value is set to increase immediately until it equals the capacitive field value. After the set time period T2, the monitoring device 1 will know that the user is no longer interacting with the drug pen 100 and will be able to enter a sleep, low-power, or inactive mode.

[0125] It should be noted that, as mentioned previously, if the capacitive field value measures the capacitive field inversely, the dynamic capacitive threshold value will also be configured inversely. In such a case, the dynamic capacitive threshold value is configured to increase slowly when the capacitive field value rises above the dynamic capacitive threshold value, and to decrease rapidly to at least equal the capacitive field value once the capacitive field value falls below the set threshold value. In this respect, the present invention covers both possibilities.

[0126] In another particular embodiment, as shown in Figs. 1A, 1B, 2A, 2B, the monitoring device further comprises an external push button 4 configured to activate the push button 101 of the drug pen 100.

[0127] The external push button 4 can have various shapes and configurations to suit the specific needs of the application. Most monitoring devices 1 rely on axial translation via a piston element that moves when the external push button 4 is pressed, which in turn activates the push button 101 of the drug pen 100. However, electronic or electromechanical elements such as a push button or a touch sensor can be used, which emits a signal indicating that the push button 101 of the drug pen 100 should be pressed, thereby activating an actuator.

[0128] In this embodiment, the push button 4 comprises a rigid perimeter frame 4a and a flexible layer 4b. The perimeter frame 4a is any structure that covers the outer area of ​​the push button. Those skilled in the art are aware of various ways in which this can be done depending on the shape and size of the push button 4, such that the perimeter frame 4a does not cover the central area of ​​the push button 4. In the present invention, a rigid structure is understood to be one with a rigidity that configures it to at least prevent the push button 4 from being actuated when only the rigid perimeter frame 4a is pressed. In the present invention, a flexible structure is understood to be one with a flexibility that configures it to at least allow the push button 4 to be actuated when only the flexible layer 4b is pressed.

[0129] Advantageously, this prevents the external button from being pressed accidentally. When the monitoring device 1 is placed in a bag, pocket, backpack, or container, the button is often compressed by another element or surface of the bag, pocket, backpack, or container. This results in false button press events of the pen's button 101, which can be interpreted as injection or purging attempts, i.e., a false positive. The term "false positive" in the context of the present invention refers to the erroneous detection of an injection event, for example, after an accidental press.

[0130] The provision of a rigid perimeter frame 4a prevents the external push button 4 from being pressed unless the central area of ​​the external push button 4, covered by the flexible outer layer 4b, is pressed, but not the rigid perimeter frame 4a. This occurs only when the push button is intentionally pressed with a user's finger. Advantageously, this embodiment significantly reduces the number of false presses, allowing for more reliable monitoring and tracking of user adherence.

[0131] In a preferred embodiment, the flexible layer 4b is external to the rigid perimeter frame 4a.

[0132] In a preferred embodiment, the push button 4 comprises a visual or haptic element in the flexible outer layer 4b within the area bounded by the rigid perimeter frame 4a. This visual or haptic element allows the user to more easily recognize where to press to ensure that the monitoring system 1 records their activity.

[0133] In another particular embodiment, the one or more sensors 3 comprise a pulse sensor and an orientation sensor.

[0134] The pulse sensor is configured to detect when the user presses button 101 on the drug pen 100. The pulse sensor can be associated with external button 4, as a switch between external button 4 and button 101 on the pen 100.

[0135] The orientation sensor is configured to determine the orientation of the Drug Pen 100. The orientation sensor can be an accelerometer or a gyroscope. An accelerometer can be used to measure the vertical orientation of the pen by analyzing the gravity acting upon it. As the pen tilts, the vertical component of gravity decreases, indicating tilt. The vertical orientation of the Drug Pen 100 can be determined using an accelerometer via a mathematical formula or a table of equivalences.

[0136] In this embodiment, the processing unit (2) is configured to process the pulse sensor and orientation sensor signals to determine whether the drug pen (100) is being purged or injected.

[0137] As shown in Figure 8 and as explained in Example 1, the injection and purging actions by the users are performed at different angles.

[0138] Advantageously, this allows differentiation between two confoundable events such as purging and injection, which otherwise could significantly alter the collected data, leading to a loss of data fidelity and poorer treatment follow-up.

[0139] It is emphasized that, for this purpose, the user does not need to alter their method of injecting or purging the drug pen 100, nor indicate in any way to the monitoring device the intention to perform either of the two actions, thus facilitating adherence

[0140] In a preferred embodiment, a timer is used to avoid false positives. This allows for setting a minimum time that the push button must be pressed for an injection or purging event to be recorded using the pulse sensor and orientation sensor signals.

[0141] In a preferred embodiment, the processing unit (2) is configured to determine whether the drug pen (100) is being purged or injected according to the orientation of the drug pen (100) as determined by the orientation sensor when the pulse sensor detects that the button (101) is pressed.

[0142] In this way, it is only necessary to monitor the orientation of the drug pen 100 at specific times, helping to save energy without requiring the user to take any action other than what the pen requires by default, which is to press button 101 to inject or purge the drug pen 100 as appropriate.

[0143] In another preferred embodiment, an orientation below a value between 40° and 70° indicates that the Drug Pen 100 is being purged, and / or an orientation above a value between 40° and 70° indicates that the Drug Pen 100 is being injected. The orientation is measured with respect to the vertical axis upwards, as determined by the orientation sensor. As shown in Example 1 and Fig. 8, an orientation below a value between 40° and 70° indicates that the Drug Pen 100 is being purged, and / or an orientation above a value between 40° and 70° indicates that the Drug Pen 100 is being injected.

[0144] In another preferred embodiment, an orientation less than 45° from the vertical component indicates that the Drug Pen 100 is being purged, and / or an orientation greater than 45° indicates that the Drug Pen 100 is being injected. The orientation is measured with respect to the vertical axis upwards, as determined by the orientation sensor.

[0145] In an even more preferred embodiment, an orientation lower than any value between 0 o and 40° from the vertical component is indicative that the drug pen 100 is being purged, as shown in Example 1 and Fig. 8.

[0146] In another, even more preferred embodiment, an orientation higher than any value between 40 0 and 180 0The vertical component indicates that the drug pen 100 is being injected, as shown in Example 1 and Fig. 8. In another particular embodiment, the one or more sensors 3 further comprise a pulse sensor and a timer.

[0147] The pulse sensor is configured to detect when the user presses button 101 on the drug pen 100. The pulse sensor can be associated with external button 4, as a switch between external button 4 and button 101 on the pen 100.

[0148] The timer can be an external sensor or integrated into processing unit 2.

[0149] In this embodiment, the processing unit 2 is configured to process the pulse sensor and timer signals to determine whether the drug dose selected by the rotary dose selector 104 has been administered correctly.

[0150] Correct drug administration can be determined either by the complete expulsion or administration of the prescribed drug dose, or by following the manufacturer's recommendations for achieving such complete administration. In this sense, the term "correctly" is interpreted in the context of the present invention as both the complete expulsion or administration of the prescribed drug dose and following the manufacturer's recommendations for achieving such complete administration.

[0151] Drug pen manufacturers recommend minimum injection times before removing the pen needle from the skin. For example, insulin pen manufacturers recommend waiting 4 to 6 seconds, depending on the device, before removing the needle from the skin to prevent insulin leakage.

[0152] Maintaining the insulin injection pulse for a few seconds before removing the needle is an important practice for several reasons.

[0153] • Keeping the injector pressed in place allows the full dose of medication (e.g., insulin) to be delivered before removing the needle. This is crucial to ensure the patient receives the full prescribed amount of medication.

[0154] • Some medications, such as insulin, are liquids that can easily leak if the needle is withdrawn too quickly. Applying pressure for a few seconds after injection helps seal the injection site and reduces the risk of leakage or drug runoff.

[0155] Maintaining pressure facilitates drug absorption into subcutaneous tissues. This can contribute to more consistent and predictable drug absorption, which is essential for effective treatment management. For example, in the case of insulin, it is essential for effective blood sugar control.

[0156] Advantageously, this allows you to know if the drug contained in the 100 drug pen has been fully injected without requiring the user to take any action other than the one the pen requires by default, which is to press button 101 to inject or purge the 100 drug pen as the case may be.

[0157] Furthermore, timing data can be used later to adjust the amount of drug injected, thus better predicting the patient's treatment. If user feedback is available, auditory or visual cues can be provided to the user to improve their injection technique if they are not maintaining the pressure for a sufficient duration.

[0158] In a preferred embodiment, the processing unit 2 is configured to determine that the drug dose selected by the rotary dose selector 104 has been fully administered when the timer determines that the pulse sensor has been pressed for a minimum of between 4 and 6 seconds.

[0159] In another preferred embodiment, of any of the embodiments comprising a pulse sensor, the pulse sensor 3 is a mechanical switch. Advantageously, this allows that when the monitoring device comprises an external push button 4, which can axially transfer the movement towards the weigher 101, the mechanical switch located at said axial translation of the movement can serve as a pulse sensor, such that the processing unit 2 can know the moment when the user presses the push button 101 of the drug pen 100.

[0160] In another particular embodiment, the one or more sensors 3 comprise a microphone suitable for recording ultrasound, a capacitive sensor, a push button, a pulse sensor, at least one orientation sensor, and a timer.

[0161] The combination of these sensors allows for the grouping and integration of different information about parameters related to the Drug Pen 100 and / or a drug contained within it. This enables the detection of various states or events and the monitoring of one or more parameters related to the Drug Pen 100 or a drug contained within it, preventing false positives and erroneous measurements.

[0162] In particular, the combination of all the sensors allows the monitoring device 1 to operate without any user intervention. In this sense, it becomes transparent to the user, functioning autonomously and monitoring the drug pen 100 to which it is attached, while the user uses the drug pen 100 as they normally would without the monitoring device 1 attached. There are no additional processes involved, except for charging the device when the battery is depleted, for example, every two weeks, and transferring the monitoring device 1 from one pen 100 to another each time the disposable pen is changed. Furthermore, changing the pen does not require separating and reattaching different parts of the monitoring device 1, as it is a single unit. This is highly desirable for user adherence to and adoption of the technology.

[0163] • The capacitive sensor turns on automatically without needing to be switched on beforehand via a manual switch or a specific actuation.

[0164] • The added sound to the gyroscope allows a unit device to distinguish the selected and injected units regardless of the position in which the user holds the device, and whether or not they move it.

[0165] • The button and capacitive sensor that prevent false injections help to avoid requiring any on / off process, thus preventing the registration of false injections (false positives).

[0166] • The position-detecting accelerometer helps detect purges naturally and without processing, thus increasing the reliability of recorded injections by preventing them from being confused with purges. In a preferred embodiment, the microphone suitable for recording ultrasound is a microphone according to any of the embodiments mentioned above. Alternatively or additionally, the capacitive sensor is a capacitive sensor according to any of the embodiments mentioned above. Alternatively or additionally, the push button is a push button according to any of the embodiments mentioned above. Alternatively or additionally, the pulse sensor is a pulse sensor according to any of the embodiments mentioned above. Alternatively or additionally, the orientation sensor is an orientation sensor according to any of the embodiments mentioned above.Alternatively or additionally, the timer is a timer according to any of the embodiments mentioned above. Furthermore, processing unit 2 is a processing unit 2 according to any of the embodiments mentioned above, respectively.

[0167] This allows combining two or more of the above advantages in a single monitoring device 1. Since they all contribute to monitoring the drug pen without altering the predetermined use of the drug pen, the monitoring device 1 benefits from not needing to change its behavior with respect to the drug pen 100 in any of the drug pen interactions.

[0168] In a more preferred embodiment, the microphone suitable for recording ultrasound is a microphone suitable for recording ultrasound according to any of the embodiments mentioned above; the capacitive sensor is a capacitive sensor according to any of the embodiments mentioned above; the push button is a push button according to any of the embodiments mentioned above; the pulse sensor is a pulse sensor according to any of the embodiments mentioned above; the orientation sensor is an orientation sensor according to any of the embodiments mentioned above; and the timer is a timer according to any of the embodiments mentioned above. Furthermore, the processing unit 2 is a processing unit 2 according to any of the embodiments mentioned above, respectively.

[0169] By combining each and every one of the aforementioned advantages into a single monitoring device, a synergistic effect is achieved, making the monitoring device completely transparent to the user. The combination of all the aforementioned devices means that the user will not notice any difference in the use of the drug pen with or without the monitoring device, resulting in greater continuity of use and, therefore, better recording and monitoring of treatment adherence.

[0170] In another particular embodiment, the monitoring device 1 comprises user feedback means, configured to indicate to the user how to act on certain occasions or to issue alarms.

[0171] For example, processing unit 2 can be configured to provide the user with various confirmations and acoustic alerts through feedback means:

[0172] • Injection completed by holding the button down long enough for a proper injection

[0173] • Insufficient pressing time

[0174] • Alarm: It's time to take a dose

[0175] • Double click: different sound depending on whether you have already taken the dose or not

[0176] All of the above is fully within the scope of this disclosure and is deemed to form the basis for alternative embodiments in which one or more combinations of the features described above are applied, without limitation to the specific combination disclosed above.

[0177] In light of this, there will be many alternatives for implementing the teaching of this disclosure. It is expected that a person skilled in the art will be able to modify and adapt the above disclosure to suit their own circumstances and requirements within the scope of this disclosure, while retaining some or all of its technical effects, whether disclosed or derived from the above, in light of their common general knowledge of this art. All such equivalents, modifications, or adaptations fall within the scope of this disclosure.

[0178] Example

[0179] To confirm that an injection or purge has occurred, the system also requires the user to press the button for at least two seconds without interruption. A button press event is triggered when the accelerometer measures the orientation of the insulin pen to determine whether the event was a priming or an injection.

[0180] A purge or injection event is detected as a purge if the accelerometer's Z-value exceeds 3450 (gravity is 4900 for our accelerometer), which corresponds to approximately 45 degrees in cases where there is no additional acceleration besides gravity. Above this value, the event is a purge; below this threshold, the event is an injection. This configuration is used because components can inject horizontally or vertically, and therefore the boundary between injections and purges lies between horizontal injections and vertical purges. Horizontal injections, typically in the abdomen and arms, are more common, while downward injections, usually in the legs, occur less frequently.

[0181] Materials and methods

[0182] Accelerometer data is used to assess whether the insulin pen is pointing upwards, indicating that the event was a purge.

[0183] The accelerometer's stored data indicates the direction of acceleration, primarily caused by the inertial force of gravity. The orientation angle is defined by the criterion that upwards is 0 degrees and downwards is 180 degrees.

[0184] A study was conducted using various purge and injection records. A total of 1657 priming events were recorded and analyzed. Figure 9 shows the probability distribution of the user purging the pen with different orientations. The calculation was performed by dividing the number of purges with that orientation by the total number of purges.

[0185] Following the same procedure with the 2506 injections instead of the purges, Fig. 10 shows the probability that the injections have a certain orientation.

[0186] Results

[0187] In Figure 9, for the purges, it can be seen that the maximum is not at 0 degrees. This is understandable since the cross-section around 0 degrees is much smaller than the cross-section at a higher angle. The decay of the distribution is faster than the exponential decay of the Gaussian distribution. Therefore, the tails of the distribution are quite short.

[0188] In Fig. 10, a much more pronounced minimum can be seen around 180 degrees. In this case, the reason is twofold. In addition to the smaller cross-section described above, the second reason is that more horizontal injections occur, applied to the abdomen and arms, and fewer downward-pointing injections occur, usually in the leg.

[0189] By plotting both distributions together (Fig. 8), it can be seen that their overlap is very small.

[0190] Overlap is a way to determine the probability of confusing one event with another. In this figure, it can be experimentally observed that there is a clear section in the orientation between 40 and 70 degrees where there were almost no injections, and no injections were recorded between 40 and 70 degrees. Therefore, a cutoff point can be established at an orientation value between 40° and 70°, where the orientation is measured with respect to the vertical axis upwards, as determined by the orientation sensor.

[0191] The 45° limit is convenient for two reasons:

[0192] • The decline of purging events with orientation is more drastic.

[0193] • The risk of mistaking a purge and a measurement for an injection is less than mistaking an injection and a measurement for a purge, since repeating an injection - because there were no injections in the diary as it was mistaken for a purge - could cause hypoglycemia, which poses a greater risk than not giving an injection because there was already a false injection in the diary.

Claims

CLAIMS 1. A monitoring device (1) adapted for coupling to a drug pen (100), said pen (100) comprising a push button (101) and a rotary dose selector (104), wherein the monitoring device (1) comprises: a. a processing unit (2), and b. one or more sensors (3) configured to monitor one or more parameters related to the drug pen (100) and / or to a drug contained in said drug pen (100); wherein the processing unit (2) is configured to process the data received by the one or more sensors (3) and monitor the one or more parameters from the predetermined use of the drug pen (100).

2. Monitoring device (1) according to claim 1, wherein the one or more sensors (3) comprise a microphone suitable for recording ultrasound and wherein the processing unit (2) is configured to process the audio signal recorded by the microphone to select one or more audio samples in the ultrasound range indicative of one or more of the following: the number of drug units dispensed by the drug pen (100) and / or the number of units selected on the rotary dose selector (104) of the drug pen (100).

3. Monitoring device (1) according to claim 2, wherein the processing unit (2) is configured to process sounds above 25 kHz, preferably sounds of approximately 30 kHz.

4. Monitoring device (1) according to any of claims 2 or 3, wherein the processing unit (2) is configured to select one or more audio samples according to an algorithm of patch grouping, peak detection, zero removal, short sample removal, low amplitude removal, distance grouping and / or characterization and grouping.

5. Monitoring device (1) according to any of claims 2 to 4, wherein the one or more sensors (3) further comprise an orientation sensor, and wherein the processing unit (2) is further configured to process the one or more selected audio samples using the information recorded by the orientation sensor.

6. Monitoring device (1) according to claim 1, wherein the one or more sensors (3) comprise a capacitive sensor, and wherein the processing unit (2) is configured to process the capacitive field detected by the capacitive sensor to determine whether the user is using the drug pen (100) by means of a capacitive threshold value, wherein when said capacitive threshold value is reached, the processing unit (2) determines that the user is using the pen.

7. Monitoring device (1) according to claim 6, wherein the processing unit (2) is configured to process the capacitive field by setting a dynamic capacitive threshold value, wherein the dynamic capacitive threshold value is configured to decrease slowly when the capacitive field value falls below the dynamic capacitive threshold value, and wherein the dynamic capacitive threshold value is configured to increase rapidly to at least equal the capacitive field value once the capacitive field value exceeds the set threshold value.

8. Monitoring device (1) according to any of claims 1 to 7, wherein the monitoring device further comprises an external push button (4) configured to activate the push button (101) of the pen, wherein the push button (4) comprises a rigid perimeter frame (4a) and a flexible layer (4b).

9. Monitoring device (1) according to any of claims 1 to 8, wherein the one or more sensors (3) further comprise an orientation sensor and a pulse sensor, and wherein the processing unit (2) is configured to determine whether the drug pen (100) is being purged or injected according to the orientation of the drug pen (100) as determined by the orientation sensor when the pulse sensor detects that the button (101) is pressed.

10. Monitoring device (1) according to claim 9, wherein an orientation less than a value between 40° and 70° is indicative that the drug pen 100 is Being purged and / or an orientation greater than a value between 40° and 70° is indicative that the drug pen 100 is being injected, where the orientation is measured with respect to the vertical axis upwards as determined by the orientation sensor.

11. Monitoring device (1) according to any of claims 1 to 10, wherein the one or more sensors (3) further comprise a pulse sensor and a timer, and wherein the processing unit (2) is configured to process the pulse sensor and timer signals to determine whether the drug dose selected by the rotary dose selector (104) has been administered correctly.

12. Monitoring device (1) according to any of claims 8 to 11, wherein the pulse sensor is a mechanical switch.

13. Monitoring device (1) according to claim 1, wherein the one or more sensors (3) comprise a microphone suitable for recording ultrasound, a capacitive sensor, a push button, a pulse sensor, at least one orientation sensor, and a timer.

14. Monitoring device (1) according to claim 13, wherein the microphone suitable for recording ultrasound is a microphone according to any of claims 2 to 5, and / or wherein the capacitive sensor is a capacitive sensor according to any of claims 6 to 7, and / or wherein the push button is a push button according to claim 8, and / or wherein the pulse sensor is a pulse sensor according to any of claims 13 to 5. 9 to 11 and / or wherein the orientation sensor is an orientation sensor according to any of claims 9 to 10, and / or wherein the timer is a timer according to claim 11 and wherein the processing unit (2) is a processing unit (2) according to any of claims 2 to 5 and / or 6 to 7 and / or 8 and / or 9 to 11 and / or 9 to 10 and / or 11, respectively.

15. Monitoring device (1) according to claim 13, wherein the microphone suitable for recording ultrasound is a microphone according to any of claims 2 to 5, and wherein the capacitive sensor is a capacitive sensor according to any of claims 6 to 7, and wherein the push button is a push button according to claim 8 and wherein the pulse sensor is a pulse sensor according to any of claims 9 to 11 and wherein the orientation sensor is an orientation sensor according to any of claims 9 to 10, and wherein the timer is a timer according to claim 11 and wherein the processing unit (2) is a processing unit (2) according to any of claims 2 to 5, 6 to 7, 8, 9 to 11, 9 to 10 and 11, respectively.

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