WO2016162298A1

WO2016162298A1 - Portable module for detecting an infusion of the contents of a syringe

Info

Publication number: WO2016162298A1
Application number: PCT/EP2016/057320
Authority: WO
Inventors: Albert Sinfreu Alay; Oleguer TAPIAS GARCIA
Original assignee: Albert Sinfreu Alay; Tapias Garcia Oleguer
Priority date: 2015-04-07
Filing date: 2016-04-04
Publication date: 2016-10-13

Abstract

The invention relates to a portable module for detecting an infusion of the contents of a syringe when the portable module is attached to said syringe, the syringe comprising a barrel extending in a longitudinal direction and a plunger seal adapted to slide inside the barrel along said direction, wherein the portable module comprises: a module frame; attachment means disposed on the module frame, the attachment means being adapted for attaching the module frame to the syringe; a control unit arranged in the module frame; a communication unit arranged in the module frame and operatively connected to the control unit; and a sensor arranged in the module frame and operatively connected to the control unit; wherein the sensor is configured to measure a physical signal indicative of a position and/or displacement of the plunger seal along said direction; and wherein the control unit is configured to determine when the plunger seal reaches an end of the barrel proximate to a needle hub based on a sequence of measurements provided by the sensor.

Description

PORTABLE MODULE FOR DETECTING AN INFUSION OF THE CONTENTS OF A

SYRINGE

FI ELD OF THE INVENTION

The present invention relates to a portable module for detecting an infusion of the contents of a syringe. In particular, the portable module of the invention makes it possible to improve the traceability of treatment adherence of self-medicating patients, while at the same time enhances the feedback provided to physicians and/or pharmacists regarding medicine administration. Moreover, the portable module of the invention provides an easy-to-use and reusable module that self-medicating patients can use at home without the supervision or assistance of medical personnel.

BACKGROUND OF THE I NVENTION

Chronic diseases, such as diabetes or hemophilia, require a continued treatment, sometimes even for prophylactic reasons. At the same time, there are several non-chronic health diseases, such as lower back pain or lumbalgia, which still require a long-term treatment. In most cases, the medicines used in the treatments of these diseases are extremely expensive and, for this reason, they are usually commercialized in an injectable format, in which a syringe is preloaded with the predetermined dose of medication prescribed by the physician. In order to improve their life quality, patients typically administer the medicines by themselves at home, rather than having to come periodically to the hospital or medical center to have each dose of medication administered by medical personnel.

However, patient self-medication poses a problem of traceability, as the physician that prescribed the treatment and the medical center lose track of whether a given patient makes an appropriate use of the medicines (i.e., treatment adherence) and date and time when each dose is administered. As a result, the patient's medical history cannot be updated in an accurate way. Not having adequate traceability on treatment adherence leads to a loss of very valuable information for the physician, and makes it difficult for medical centers to justify the costs of the medication that is supplied to the patients.

Another problem associated with patient self-medication is how to ensure that the physician is thoroughly and promptly apprised of the evolution of the treatment on a given patient. For example, in the case of prophylactic therapy, a physician may see the patient once every two or three months whilst he or she is taking the prescribed medicine twice or three times a week. Usually patients are provided with forms to be filled in and to be returned to the physician. However, many times these forms are not filled out correctly, or even they are lost. In other cases the data submitted by the patient is not trustworthy, because the patient filled out the forms several days after the medication was administered.

As the feedback provided by patients to the physician decreases, the physician's knowledge on the adherence of each patient to the treatment is severely compromised. This is especially the case when a patient experiences extra episodes of the disease, to which he or she usually reacts by self-medicating with some extra medicine from the stock of medication delivered to him or her. It is in such situations when submitting real-time information to the physician is key to understand why the extra medication was needed and assess whether the treatment needs to be adapted. Many times, especially when prophylactic treatment is necessary or when the medicine is very expensive, the patient has to go to the hospital's pharmacy usually on a monthly basis to pickup the medication. In this case, if a patient anticipates that it will need extra treatment during a certain month, he or she has to remember to tell the hospital's pharmacy so that they can arrange the stocks.

Document US 2013/0222135 A1 describes a system interconnecting a patient with a physician and a pharmacist, which comprises a refillable medication container configured to contain pills or injection bottles that can be dispensed to the patient as needed and that is capable of sending an alarm to the system when the patient is running out of medicines and the container needs to be refilled.

Although the system disclosed therein represents an improvement on the logistics on the medicine side, as it tries to ensure that the patient has an adequate stock of medicines at any time, this solution does not provide any traceability on treatment adherence because there is no control on whether the medicines dispensed from the medication container are actually administered and when. It is disclosed in document US 8,630,842 B2 a method for producing healthcare data records from graphical inputs by computer users, in which patients can provide feedback to their physicians in a graphical way. However, this feedback is not tied to the moment when some medicine is administered to the patient and, hence, it carries little information on actual treatment adherence.

It is also known the use of devices, such as infusion pumps, adapted to control via different electro-mechanical actuators coupled to the plunger of a syringe the exact dose of a medicine contained in said syringe that is administered to a patient.

Since these devices are designed to administer the medicine at a slow and precise rate, the needle of the syringe needs to remain inserted in the patient's body for quite a long time. Moreover, infusion pumps are typically bulky, as the syringe needs to be kept on a platform where it can be coupled to the electro-mechanical actuators in order to be able to move the plunger. Therefore, such devices are not suitable for detecting a full infusion of the contents of a syringe, let alone for being used in a home environment in the context of supervising patient self-medication. It is therefore an object of the present invention to provide a portable module for detecting an infusion of the contents of a syringe capable of providing the physician with traceability on treatment adherence of a self-medicating patient and information on extra events that may have happened. It is also an object of the present invention to provide a portable module for detecting an infusion of the contents of a syringe in which the information relating to the treatment adherence can be sent to a physician and/or a pharmacist as soon as it is detected the intravenous, intramuscular, intradermal, or subcutaneous administration of an injectable solution or medicine contained in the syringe.

It is yet another object of the present invention that the portable module be a modular, simple and reusable solution to facilitate its use to the patient while at home and without requiring the assistance of medical personnel. SUMMARY OF THE INVENTION

The objects of the present invention are solved with the portable module for detecting an infusion of the contents of a syringe of claim 1 . Other favorable embodiments of the invention are defined in the dependent claims.

An aspect of the present invention relates to a portable module for detecting an infusion of the contents of a syringe when the portable module is attached to said syringe, the syringe comprising a barrel extending in a longitudinal direction and a plunger seal adapted to slide inside the barrel along said direction, wherein the portable module comprises:

a module frame;

attachment means disposed on the module frame, the attachment means being adapted for attaching the module frame to the syringe;

a control unit arranged in the module frame;

- a communication unit arranged in the module frame and operatively connected to the control unit; and

a sensor arranged in the module frame and operatively connected to the control unit; wherein the sensor is configured to measure a physical signal indicative of a position and/or displacement of the plunger seal along said direction; and wherein the control unit is configured to determine when the plunger seal reaches an end of the barrel proximate to a needle hub based on a sequence of measurements provided by the sensor.

In accordance with the invention, by attaching the portable module directly on the syringe, the infusion of the medicine contained in the syringe can be readily detected. The control unit of the portable device processes a sequence of measurements obtained with the sensor to determine accurately when the plunger seal reaches the end of the barrel close to the needle hub, which indicates that the medicine has been administered to the patient. Thus, the portable module of the present invention allows verifying the adherence of a self-medicating patient to the prescribed treatment, and having a record of any extra events needed.

At the same time, the inclusion of a communication unit in the portable module makes it possible to provide information to the physician and/or pharmacist relating to whether the patient complies with the treatment and if extra doses have been necessary. Moreover, this feedback can be provided in real time when the portable module determines that the medicine contained in the syringe has been administered. Having information regarding when and why patients followed or not the treatment, or had extra treatment, improves the traceability on adherence to their treatment and increases the data contained in their medical history, which helps to understand the variability in terms of dosage required by patients suffering a same kind of disease. .

Furthermore, conversely to the systems known in the prior-art, in which the syringe has to be held in a specific position and is actuated by some electro-mechanical actuator, the portable module of the present invention simply attaches to a conventional syringe without interfering with the way the syringe is to be used by the patient. This makes the portable module of the present invention easy to use and allows patients to administer the medication by themselves at home without the supervision or assistance of medical personnel

Although the main use of the portable module of the present invention is to measure treatment adherence in humans self-medicating at home, the invention can also be used for veterinary purposes, such as for example to count the amount of shots administered to farm animals, sending that information in real time to veterinaries for invoicing purposes or farm medical history tracking, among others.

In a first group of embodiments according to the present invention, the attachment means comprises a lower piece adapted to attach the module frame, when the portable module is attached to said syringe, to a plunger top provided at a free end of a plunger mechanically coupled to the plunger seal.

By attaching the portable module to the plunger top of the syringe, the ergonomics of the syringe is essentially not altered, so that the patients can continue to hold the syringe by its barrel as in any conventional syringe.

In the context of the present invention the free end of the plunger of a syringe preferably refers to the end of the plunger that is not adapted to be coupled to the plunger seal of said syringe.

Preferably in the embodiments of this first group, the module frame has a first surface adapted to be mounted on the plunger top and a second surface, opposite to the first surface, operatively coupled to the sensor. In this manner the sensor is advantageously coupled to the surface of the module frame adapted to receive the thumb of the person actuating the plunger of the syringe. More preferably, in these embodiments the module frame is shaped as a disc or a pillbox.

Module frame geometries having low profile are advantageous to avoid an excessive increase in the total length of the plunger, which would degrade the ergonomics of the syringe.

Optionally in this first group of embodiments, the lower piece comprises a flat portion and a perimetral rim, said perimetral rim being adapted to engage a corresponding perimetral recess on the first surface of the module frame. Additionally, when the lower piece is coupled to the module frame and attached to the plunger top, the plunger top is squeezed between the flat portion of the lower piece and the first surface of module frame.

In this way, the portable module can be properly held on the plunger top. The perimetral rim may span an angle of at least 90, 135, 180 or even 225 degrees. Additionally, the flat portion may advantageously comprise a slot having a shape matching at least part of the shape of the cross-section of the plunger of the syringe.

In these embodiments, the lower piece may also comprise a moveable member that can be disposed in a closed position, in which the moveable member in cooperation with the perimetral rim of the lower piece defines a closed perimeter that secures the module frame on the plunger top, and in an open position, in which the moveable member is receded allowing the plunger top to be extracted from the lower piece.

In this manner, any accidental release of the portable module from the plunger top is prevented.

In some embodiments of this first group, the sensor is a force sensor adapted to measure a force applied on the second surface of the module frame. A force (or a mechanical pressure) applied on the second surface of the module frame will be transmitted through the body of the plunger to its end coupled to the plunger seal, which results in a displacement of the latter. Therefore, the force applied to the second surface of the module frame is a signal indicative of a displacement of the plunger seal. More preferably, in these embodiments, the portable device further comprises an upper piece provided with a push button mechanically coupled to the second surface of the module frame, such that a force applied on the push button is transmitted to the second surface of the module frame.

The push button of the upper piece transmits more uniformly the force exerted by the user to the second surface of the portable module, facilitating the detection of this force with the pressure sensor.

Optionally, the upper piece has a substantially semispherical shape; and, preferably, the upper piece comprises a peripheral internal thread adapted to engage a corresponding external thread provided on the module frame.

In some other embodiments of this first group, the sensor is a temperature sensor adapted to measure a temperature on the second surface of the module frame. Alternatively, the sensor may be a motion and/or acceleration sensor adapted to measure a displacement and/or acceleration imparted on the second surface of the module frame.

A temperature sensor coupled to the second surface of the module frame can advantageously measure the change in temperature on said second surface when the thumb of the user pushes the plunger, which results in a displacement of the plunger seal towards the end of the barrel proximate to the needle hub.

In a second group of embodiments according to the present invention, the module frame comprises:

a main body having a surface adapted to receive the cylindrical surface of the barrel of the syringe; and

a positioning element connected to the main body and adapted to receive the end of the barrel proximate to the needle hub and to prevent the displacement of the main body towards the opposite end of the barrel along its longitudinal direction when the portable module is attached to the syringe.

By attaching the portable module to the cylindrical surface of the barrel, the dimensions of the module frame can be more freely selected without the restrictions imposed by the dimensions of the plunger of the syringe. In some embodiments of this second group, the positioning element comprises an annular portion adapted to surround at least partially the end of the barrel proximate to the needle hub when the portable module is attached to the syringe, said annular portion having an inner diameter smaller than the diameter of the barrel but larger than the diameter of the needle hub.

Alternatively, in other embodiments of this second group, the positioning element comprises two flat tabs that protrude from the main body. The flat tabs are adapted to contact the end of the barrel proximate to needle hub at opposite sides of the needle hub when the portable module is attached to the syringe.

In some embodiments of this second group, the sensor is arranged on said surface of the main body adapted to receive the cylindrical surface of the barrel, and proximate to the positioning element. In this manner the sensor is also in contact with the cylindrical surface of the barrel, so that it can more efficiently measure said physical signal indicative of the position and/or displacement of the plunger seal. In some other embodiments of this second group, the module frame comprises two side portions facing each other and each having an end arranged proximate to the positioning element. Moreover, the side portions are connected to the main body such that, when the portable module is attached to the syringe, the side portions are placed on two opposite sides on the cylindrical surface of the barrel. Additionally, the sensor comprises a first sensor element provided on one of the two side portions, and a second sensor element provided on the other side portion.

Such an arrangement of the side portions and the sensor elements is advantageous as the infusion of the contents of the syringe can be more easily and reliably detected when the plunger seal passes between the two sensor elements.

Preferably, the first and second sensor elements are provided, respectively, on said ends of the side portions. In the context of the present invention, a sensor, a sensor element and/or an end of a side portion of the module frame is considered to be proximate to the positioning element of the portable module if the distance of the former to the positioning element along said longitudinal direction is smaller than, or equal to, 1 , 1 .5, 2 or even 2.5 times the thickness of the plunger seal of the syringe to which the portable module is attached. Given that the thickness of a plunger seal in conventional syringes is typically between 1 and 15 mm, said sensor, sensor element and/or end of the side portion will be considered to be proximate to the positioning element of the portable module if said distance is not larger than 25 mm.

Optionally, the first sensor element is an optical transmitter and the second sensor element is an optical receiver operatively coupled to the optical transmitter.

Such an arrangement may be advantageous in those cases in which the contents of syringe does not have a very high light transmission loss coefficient. In said cases, a sudden drop in the level of signal detected at the optical receiver indicates that the plunger seal has interrupted the optical path between the optical transmitter and the optical receiver.

Alternatively, the first sensor element is an optical transceiver comprising a transmitter and a receiver, and the second sensor element is a passive optical element that redirects the light emitted by the transmitter of the optical transceiver to the receiver of the optical transceiver. A reflection-type sensor may be preferred when the light transmission loss coefficient of the contents of the syringe is very low, because the interaction path is doubled as the light travels a round trip starting at the optical transceiver and returning to it after being redirected (e.g., reflected, diffracted, or back-scattered) by the passive optical element. Moreover, since the passive optical element does not require to be powered, the electronics of the sensor and its wiring within the module frame are simplified.

The optical transmitter or the transmitter of the optical transceiver may be a LED or, alternatively, a laser diode. Furthermore, the radiation emitted may be infrared, visible or ultraviolet light.

In some other embodiments, the sensor elements may comprise electromagnetic (EM) field sensor elements capable of creating an EM field and sensing variations of said field produced by the movement of the plunger seal of the syringe. In yet some other embodiments, the sensor elements may comprise an ultrasounds emitter and receiver.

Preferably, in the embodiments of this second group, the attachment means comprises a member, more preferably a resilient member, adapted to be clipped to the barrel of the syringe.

In a third group of embodiments according to the present invention, the module frame is shaped as a plunger comprising a rod that extends between a first end and a second end, the second end having a plunger top. In addition to it, the attachment means are provided on the first end of the rod and are adapted to be mechanically coupled, preferably by screwing, to the plunger seal. Furthermore, the rod comprises a cylindrical casing in which the control unit is housed, and the sensor is provided on said rod. Such embodiments are advantageous because the entire extension of the rod of the plunger becomes available for the electronics of the portable module. In this way, the appearance of the syringe to which the portable module is attached does not significantly differs from that of a conventional syringe, making it easier to use and more ergonomic to the user. Preferably, in the embodiments of this third group, the sensor is either a force sensor adapted to measure a force applied at an end or an intermediate point of the rod of the module frame, or a motion and/or acceleration sensor adapted to measure a displacement and/or acceleration imparted on the rod of the module frame. Also preferably, in the embodiments of this third group, the portable module further comprises a second sensor operatively connected to the control unit. In such embodiments, the sensor is arranged proximate to the first end of the rod, and the second sensor is arranged on the plunger top. Optionally, the second sensor is a force sensor adapted to measure a force applied on the plunger top, or a temperature sensor adapted to measure a temperature on the plunger top.

This allows a more reliable detection of an infusion of the contents of the syringe, as not only a displacement and/or acceleration of the rod of the module frame is sensed but also whether that is accompanied by a force or change of temperature on the plunger top, which confirms that a user is actuating the plunger.

In some embodiments of the present invention, the control unit is adapted to store the measurements provided by the sensor with a predetermined periodicity and to determine that the plunger seal has reached the end of the barrel when a sequence of stored measurements matches a target sequence.

In some embodiments of a portable module including a second sensor, the control unit is adapted to store the measurements provided by the sensor and the second sensor with a predetermined periodicity and to determine that the plunger seal has reached the end of the barrel when a first sequence of stored measurements provided by the sensor matches a first target sequence and a second sequence of stored measurements provided by the second sensor matches a second target sequence.

In this manner, the determination that the plunger seal has reached the end of the barrel and, hence, that the contents of the syringe has been infused is more robust to noise and/or false alarms (such as for instance an accidental partial actuation of the plunger of the syringe).

Preferably, said predetermined periodicity is between 5msec and 20msec. In some embodiments, the portable module further comprises activation means operatively coupled to the attachment means; wherein the activation means are configured to activate the control unit when the module frame is attached to the syringe.

Such activation means allow saving battery to the portable module, as the latter can remain in a state of low or no consumption and wake up only when its module frame is attached to the syringe.

Preferably, the activation means comprises an activation sensor adapted to detect a strain or a mechanical pressure exerted on the attachments means.

Also preferably, the portable module further comprises a power management module to energize the control unit, the communication unit, the attachment means and/or the sensor. The power management module may be based on a battery, such as a rechargeable battery, or on an energy harvesting unit.

In some embodiments, the control unit comprises a processing module and a memory module.

In such embodiments, preferably, the control unit is configured to store infusion data in the memory module every time the control unit determines that the plunger seal has reached the end of the barrel proximate to the needle hub.

Optionally, in such embodiments the portable module further comprises a geolocalization unit arranged in the module frame and operatively connected to the control unit, and the control unit is configured to include a geolocalization stamp in the infusion data stored in the memory module. The geolocalization unit may comprise a GPS receiver or, alternatively, be able to obtain geolocalization data provided by a cellular or Wi-Fi network.

Also optionally, the control unit further comprises a clock module, and wherein the control unit is configured to include a time stamp in the infusion data stored in the memory module.

Also optionally, the control unit is configured to include an identification code unique to said portable module in the infusion data stored in the memory module. In this way, the portable module becomes associated to the medical history of a patient, increasing the traceability of the information sent by the portable device to a physician and/or pharmacist.

In certain embodiments, the communication unit is configured to implement one or more of the following wireless communication standards: 2G, 3G, or 4G cellular communication standards, Wi-Fi, Bluetooth, or ZigBee.

In some embodiments of the present invention, the control unit comprises means to switch across a plurality of operation modes, said plurality of operation modes including a normal operation mode, a configuration mode, a stand-by low power consumption mode and a power- level indication mode.

Another aspect of the present invention relates to a system for monitoring the administration of medication, comprising: one or more portable modules for detecting an infusion of the contents of a syringe according to any of the embodiments defined above; and a remote back- office server; wherein the one or more portable modules are configured to communicate with the remote back-office server to transmit information relative to the infusion of the medication contained in the syringe.

In accordance with the invention, the one or more portable modules can promptly notify the remote back-office server when self-medicating patients are actually having their medication administered. The remote back-office sever is configured to collect the information received from the active portable modules, store it and selectively deliver detailed or aggregated reports on treatment adherence to physicians and/or pharmacists. In this manner, physicians can have near real-time information about the evolution of their patient's treatment, and pharmacists may be able to react sooner to avoid medicine stock depletion. As a result, patients can be better attended and, therefore, their life quality improved. Optionally, the system further comprises a user terminal through which the one or more portable modules communicate with the remote back-office server, and wherein the user terminal is additionally configured to exchange patient information data with the remote back- office server.

The user terminal may act as a router, providing network access to the one or more portable modules. Additionally, the user terminal advantageously allows interaction with the patients, so that they can provide additional information regarding how the treatment is going. In the same way, the user terminal may receive communications from the remote back-office server prompting the patients to administer their medication, requesting them additional feedback on specific infusion events. The remote back-office server may also implement algorithms to interact with patients in order to promote treatment adherence.

BRIEF DESCRIPTION OF THE FIGURES

In the following some preferred embodiments of the invention will be described with reference to the enclosed figures. They are provided only for illustration purposes without however limiting the scope of the invention.

Figure 1 shows a perspective exploded view of a portable module for detecting an infusion of the contents of a syringe according to a first embodiment of the present invention.

Figure 2 depicts in a perspective view the portable module of figure 1 attached to the plunger top of a syringe.

Figure 3 illustrates a portable module according to a second embodiment of the present invention. Figure 4 corresponds to a perspective view of the portable module of figure 3 ready to be attached to the barrel of a syringe.

Figure 5 shows a portable module according to a third embodiment of the present invention about to be attached to the barrel of a syringe.

Figure 6 corresponds to a perspective exploded view of a syringe with a portable module according to a fourth embodiment of the present invention.

Figure 7 is a block diagram of a portable module for detecting an infusion of the contents of a syringe according to an embodiment of the present invention.

Figure 8 is a schematic representation of an example of a system for monitoring the administration of medication.

Figure 9 shows a block diagram a user terminal of the system of figure 8.

Figure 10 corresponds to a block diagram illustrating the architecture of the remote back-office server of figure 8.

DESCRIPTION OF THE PREFERRED EMBODIMENTS

In figures 1 and 2 it is illustrated a first embodiment of a portable module for detecting an infusion of the contents of a syringe, when the module is attached to said syringe, according to the present invention.

The syringe 1 , shown in figure 2, comprises a barrel 2 extending in a longitudinal direction, a plunger seal 6 (not visible in figure 2) adapted to slide inside the barrel along said direction, and a plunger 3 having an end mechanically coupled to the plunger seal 6 and a free end on which a plunger top 4 is provided.

The portable module 100 comprises a module frame 101 , a control unit arranged in the module frame, a communication unit arranged in the module frame and operatively connected to the control unit, and a sensor arranged in the module frame 101 and operatively connected to the control unit. The module frame 101 is shaped as a disc, having a first surface 101 a adapted to be mounted on the plunger top 4 and a second surface 101 b, opposite to the first surface, operatively coupled to the sensor. The sensor is configured to measure a physical signal indicative of a position and/or displacement of the plunger seal 6 along said direction; and the control unit is configured to determine when the plunger seal 6 reaches an end of the barrel 2 proximate to a needle hub 5 based on a sequence of measurements provided by the sensor.

The portable module 100 also includes attachment means disposed on the module frame, and adapted for attaching the module frame 101 to the syringe 1. In particular, the attachment means comprises a lower piece 102 adapted to attach the module frame 101 , when the portable module is attached to said syringe 1 , to the plunger top 4. The lower piece 102 comprises a flat portion 104 and a perimetral rim 105 adapted to engage a corresponding perimetral recess 106 on the first surface 101 a of the module frame.

As it can be seen in figure 1 , the perimetral rim 105 spans an angle of between 180 and 225 degrees, and the flat portion 104 comprises a slot having a shape that matches partially the cross-shaped cross-section of the plunger 3.

When the lower piece 102 is coupled to the module frame 101 and attached to the plunger top 4, the plunger top 4 is squeezed between the flat portion 104 of the lower piece and the first surface 101 a of module frame. The sensor in the portable device 100 is a force sensor adapted to measure a force applied on the second surface 101 b of the module frame. For that purpose, the portable module 100 further comprises an upper piece 103 having a substantially semispherical shape, which is provided with a push button 107 mechanically coupled to the second surface 101 b of the module frame, such that a force applied on the push button is transmitted to the second surface of the module frame.

When the user actuates the plunger 3 to infuse the contents of syringe 1 , the force sensor will initially detect an increase in the force applied on the plunger top 4 from a zero or reference value to a high value. Then the force measurements will remain at this high value for some time, corresponding to the time during which the plunger seal 6 travels towards the end of the barrel 2 proximate to the needle hub 5. Finally, once the plunger seal 6 hits said end, the measured force will decrease from the high value to the zero or reference value.

The control unit of the portable module 100 is adapted to store the measurements provided by the sensor with a periodicity of 10msec and determines whether the plunger seal 6 has reached the end of the barrel 2 by comparing a sequence of stored measurements with a target sequence that simulates the force measurements that should be obtained when the user actuates the plunger 3 of the syringe. To facilitate the assembly of the upper piece 103 to the module frame 101 , the upper piece 103 comprises a peripheral internal thread 108 adapted to engage a corresponding external thread 109 provided on the module frame 101.

Referring now to figures 3 and 4, it is there shown a second embodiment of a portable module for detecting an infusion of the contents of a syringe according to the present invention.

The portable module 200 for detecting an infusion of the contents of the syringe 1 , when the portable module is attached to said syringe, includes a module frame 201 that comprises a main body 208 having a surface 204 adapted to receive the cylindrical surface of the barrel 2 of the syringe, and a positioning element 202 connected to the main body 208 and adapted to receive the end of the barrel 2 proximate to the needle hub 5. The positioning element 202 prevents the displacement of the main body 201 towards the opposite end of the barrel 2 along its longitudinal direction when the portable module is attached to the syringe 1 .

The positioning element 202 comprises an annular portion 203 adapted to surround partially the end of the barrel 2 proximate to the needle hub 5 when the portable module is attached to the syringe 1 . The annular portion 203 has an inner diameter smaller than the diameter of the barrel 2 but larger than the diameter of the needle hub 5.

Additionally, the module frame 201 comprises two side portions 205a, 205b facing each other and each having an end arranged proximate to the positioning element 202. The side portions 205a, 205b are connected to the main body 208 such that, when the portable module 200 is attached to the syringe 1 , the side portions 205a, 205b are placed on two opposite sides on the cylindrical surface of the barrel 2. Although not shown in the figures, the portable module 200 also includes a control unit and a communication unit arranged in the module frame 201 , with the communication unit being operatively connected to the control unit.

In order to determine the infusion of the contents of the syringe 1 , the portable module 200 further includes an optical sensor arranged in the module frame and operatively connected to the control unit which detects the displacement of the plunger seal 6. The control unit will determine when the plunger seal 6 reaches an end of the barrel 2 proximate to the needle hub 5 based on a sequence of measurements provided by the optical sensor. The optical sensor comprises a first sensor element 206a, in the form of an optical transmitter, which is provided on the end of side portion 205a proximate to the positioning element 202. Moreover, the optical sensor also comprises a second sensor element 206b, in the form of an optical receiver, which is provided on the end of side portion 205b proximate to the positioning element 202. Finally, the portable device 200 also includes attachment means 207 disposed on the module frame 201 that comprise a resilient member adapted to be clipped to the barrel 2 of the syringe.

The attachment means 207 are operatively coupled to activation means provided in the portable module 200 that cause the activation of the control unit of the portable module 200 when attached to the syringe 1. Said activation means comprise an activation sensor adapted to detect a strain on the resilient member of the attachment means 207.

A third embodiment of a portable module according to the present invention is depicted in Figure 5. This third embodiment is a variation on the second embodiment just described above.

As in the portable module 200 discussed in the context of figures 3 and 4, the portable module 300 comprises a module frame 301 that includes a main body 305 having a surface 304 adapted to receive the cylindrical surface of the barrel 2 of the syringe, and a positioning element 302 connected to the main body 305 and adapted to receive the end of the barrel 2 proximate to the needle hub 5 and to prevent the displacement of the main body 305 towards the opposite end of the barrel 2 along its longitudinal direction when the portable module 300 is attached to the syringe 1.

The positioning element 302 comprises two flat tabs 302a, 302b that protrude from the main body 305 and which are adapted to contact the end of the barrel 2 proximate to the needle hub 5 at opposite sides of the needle hub 5 when the portable module 300 is attached to the syringe 1 .

Moreover, the portable module 300 comprises a sensor 303 arranged on the surface 304 of the main body 305 adapted to receive the cylindrical surface of the barrel 2, and proximate to the positioning element 302.

Referring now to figure 6, it is there shown a fourth embodiment of a portable module for detecting an infusion of the contents of a syringe according to the present invention.

While sharing the same principle of operation, the portable module 400 differs from the previous three preferred embodiments illustrated in figures 1 -5 in that the module frame 401 is shaped as a plunger comprising a rod 406 that extends between a first end 406a and a second end 406b, the second end having a plunger top 402. In this embodiment, the attachment means 403 are provided on the first end 406a of the rod and are adapted to be mechanically coupled by means of screwing to the plunger seal 6 of the syringe 1 . Thus, the portable module 400 acts as the plunger for the syringe 1 , replacing the conventional plunger 3 of the syringe 1 .

The portable module 400 also comprises activation means operatively coupled to the attachment means 403. The activation means comprise an activation sensor that detects a mechanical pressure exerted on the attachment means 403 when they are screwed to the plunger seal 6 of the syringe, causing the activation of the control unit.

The rod 406 comprises a cylindrical casing 407 in which the control unit and the communication unit are housed. A force sensor 404 adapted to measure a force applied on the rod 406 is arranged proximate to a first end 406a of the rod.

Additionally, the portable module 400 further comprises a second sensor 405 operatively connected to the control unit, and which is arranged on the plunger top 402. The second sensor 405 is also a force sensor adapted to measure a force applied on the plunger top 402.

The control unit of the portable module 400 is adapted to store the measurements provided by the sensor 404 and the second sensor 405 with a periodicity of approximately 10msec, and to determine that the plunger seal 6 has reached the end of the barrel 2 when a first sequence of stored measurements provided by the sensor 404 matches a first target sequence and a second sequence of stored measurements provided by the second sensor 405 matches a second target sequence.

Figure 7 represents a block diagram of a portable module in accordance with the present invention.

The portable module 500 comprises a control unit 501 operatively connected to a communication unit 502 that implements at least one wireless communication standard and is configured to transmit information relative to the infusion of the medication contained in a syringe, one or more sensors 503 configured to measure a physical signal indicative of a position and/or displacement of the plunger seal of the syringe, and a power management module 504 to energize the portable module 500.

The control unit 501 comprises a processing module 506, a memory module 507 configured to store infusion data every time the control unit 501 determines that the plunger seal of the syringe has reached the end of the barrel proximate to the needle hub, and a clock module 508 configured to include a time stamp in the infusion data stored in the memory module 507.

The portable module 500 further includes a geolocalization unit 505 arranged in the module frame and operatively connected to the control unit 501. In this way, the control unit 501 can include a geolocalization stamp in the infusion data stored in the memory module 507.

Additionally, the control unit 501 is also configured to include an identification code unique to the portable module 500 in the infusion data stored in the memory module 507. The operation of the portable module 500 can be configured via some configuration parameters. For that purpose, the control unit 501 comprises means to switch across a plurality of operation modes, which can be selected by rotating the portable module 500 about the axis of symmetry of the barrel of the syringe to which is attached. Among the different operation modes, there are at least the following ones:

Normal operation mode.

Configuration mode, in which configuration parameters relating to wireless network access, sensor settings, or others can be set to their appropriate values.

Power-level indication mode, in which color-coded LEDs indicate the power level to the user.

Stand-by low power consumption mode, which may even include a switched-off mode.

A schematic representation of an exemplary system for monitoring the administration of medication is depicted in figure 8. In which a system 800 comprises portable modules 806 and 807 for detecting an infusion of the contents of a syringe and a remote back-office server 801. The portable modules 806 and 807 are associated, respectively, to patients 802 and 803, and are configured to communicate with the remote back-office server 801 to transmit information relative to the infusion of the medication contained in the syringe. While the portable module 807 can communicate directly with the remote back-office server 801 , the portable module 806 communicates with the remote back-office server 801 through a user terminal 808, which is additionally configured to exchange information data of patient 802 with the remote back-office server 801 .

When an infusion is detected, the portable modules 806, 807 notify the remote back-office server 801. In turn, depending on the patient's specific treatment, the remote back-office server 801 may inquiry the patient 802, 803 for extra information about the reasons why the medicine was administered. Consequently the system 800 enhances the patients' medical history and provides physicians 804 with sophisticated reports, and gives early notice to pharmacists 805 regarding the stock needed of a medicine.

The system 800 uses the Internet to communicate each component and/or user with each other. The remote back-office server 801 is able to register new users 802, 803, 804, 805 or to log them in through different roles. Moreover, the system 800 also has a mechanism through a pairing process to link a patient 802, 803 to his or her portable module or modules 806, 807. In the system 800, the following users can be distinguished:

Self-medicating patients 802, 803, each provided with a portable module 806, 807 capable of communicating with the remote back-office server. Moreover, each patient 802, 803 has a user interface to receive information and inquires from the remote back- office server 801 .

- A physician 804 is authorized, among other things, to sign up new patients to the system 800, review his patients' infusion data through a graphical interface, receive periodically detailed and/or aggregated data reports, set up a patient treatment and send questions to the patients 802, 803.

- A pharmacist 805 will receive notifications from the system 800 when the patients 806,

807 are using extra medication, so that the pharmacist 805 can react accordingly in terms of ensuring enough supply of medicines.

Referring now to figure 9, it is there shown a block diagram of the user terminal 808 that comprises the following modules:

- A core module 901 that controls the other modules implementing a state machine.

- A graphic user interface 902 that allows the patient 802 to interact with the system 800 exchanging patient information data with the remote back-office server 801 .

- A back-office communication module 905 that is in charge of the communications with the remote back-office server 801. - A push message handler 903 configured to receive push messages originating from the remote back-office server 801 and containing inquiries and/or questions that need to be answered by the patient 802.

- A communication handler 904 adapted to communicate with the portable module 806 and act as a network proxy.

Finally, the architecture of the remote back-office 801 is illustrated in the block diagram of figure 10. The remote back-office server 801 manages all the information received from the portable devices 806, 807, stores said information and delivers detailed or aggregated reports to the physician 804 and/or the pharmacist 805.

The main functions that the remote back-office server performs are:

Storing each portable device and patient past activity;

- Linking one or more portable devices to a patient;

Providing means to define each patient's medication pattern (e.g., once a week during 6 months, twice a day during a week...);

Elaborating detailed or aggregated reports on patient treatment adherence;

Defining alarms for particular patient events, which may also be sent to the physician and/or pharmacist; and

Sending to the patients inquiries regarding a given event and general questions posed by the physician.

The remote back-office server 801 comprises the following modules:

- A core module 910 that controls the other modules.

- A web interface 91 1 that enables the users 802, 803, 804, 805 to access the remote back-office server 801 in an easy way to retrieve patient data, portable devices information, reports, and to configure alarms and/or treatments for specific patients.

- A rest API module 912 configured to offer automated access to the portable modules 806 , 807 and user terminal 808 of the system 800.

- An event handler 913 adapted to receive the infusion information events from the portable modules 806, 807 active in the system 800.

- A scheduler 914 of alarms and questions, which is an artificial intelligence module that organizes the known events and/or predicts the future ones according to the patient behavior. This module also determines whether a given event from a portable module is a scheduled infusion or not, and decides whether a question has to be sent to a specific patient.

- A messaging handler 915 that cooperates with the scheduler 914 and is configured to send push messages to the patients, alleviating the scheduler 914 from having to provide such functionality.

- A business intelligence module 916 configured to aggregate the raw data stored in a database 918 to offer high added-value and sophisticated reporting to the physician 804. Some examples of detailed reports are a weekly list of those patients that have not adhered to their prescribed treatment, or a list of patients that have required extra medication, while some examples of aggregated reports are a distribution of patient adherence level, or a distribution of patients with extra medication.

- A data access module 917 to allow users of the system 800 to access specific reports from the database 918.

While the invention has been described with respect to some specific examples, including presently preferred modes of carrying out the invention, those skilled in the art will appreciate that there are numerous variations and permutations of the above described portable module, including substitution of specific elements by others technically equivalent, without departing from the scope of the invention as set forth in the appended claims.

Claims

1 . Portable module (100, 200, 300, 400, 500) for detecting an infusion of the contents of a syringe (1 ) when the portable module is attached to said syringe, the syringe (1 ) comprising a barrel (2) extending in a longitudinal direction and a plunger seal (6) adapted to slide inside the barrel along said direction, wherein the portable module comprises:

- a module frame (101 , 201 , 301 , 401 );

attachment means (102, 207, 403) disposed on the module frame, the attachment means being adapted for attaching the module frame to the syringe;

- a control unit (501 ) arranged in the module frame;

a communication unit (502) arranged in the module frame and operatively connected to the control unit (501 ); and

a sensor (206a, 206b; 303; 404) arranged in the module frame and operatively connected to the control unit (501 );

wherein the sensor is configured to measure a physical signal indicative of a position and/or displacement of the plunger seal (6) along said direction; and

wherein the control unit (501 ) is configured to determine when the plunger seal (6) reaches an end of the barrel (2) proximate to a needle hub (5) based on a sequence of measurements provided by the sensor.

2. The portable module according to claim 1 , wherein the attachment means comprises a lower piece (102) adapted to attach the module frame (101 ), when the portable module is attached to said syringe (1 ), to a plunger top (4) provided at a free end of a plunger (3) mechanically coupled to the plunger seal (6).

3. The portable module according to claim 2, wherein the module frame (101 ) has a first surface (101 a) adapted to be mounted on the plunger top (4) and a second surface (101 b), opposite to the first surface, operatively coupled to the sensor.

4. The portable module according to claim 3, wherein the module frame (1 ) is shaped as a disc or a pillbox.

5. The portable module according to claim 3 or 4, wherein the lower piece (102) comprises a flat portion (104) and a perimetral rim (105), said perimetral rim being adapted to engage a corresponding perimetral recess (106) on the first surface (101 a) of the module frame; and wherein, when the lower piece (102) is coupled to the module frame (101 ) and attached to the plunger top (4), the plunger top is squeezed between the flat portion of the lower piece and the first surface of module frame.

6. The portable module according to claim 5, wherein the lower piece (102) comprises a moveable member that can be disposed in a closed position, in which the moveable member in cooperation with the perimetral rim (105) of the lower piece defines a closed perimeter that secures the module frame (101 ) on the plunger top (4), and in an open position, in which the moveable member is receded allowing the plunger top (4) to be extracted from the lower piece (102).

7. The portable module according to any of claims 3 to 6, wherein the sensor is a force sensor adapted to measure a force applied on the second surface (101 b) of the module frame.

8. The portable module according to claim 7, further comprising an upper piece (103) provided with a push button (107) mechanically coupled to the second surface (101 b) of the module frame, such that a force applied on the push button is transmitted to the second surface of the module frame.

9. The portable module according to claim 8, wherein the upper piece (103) has a substantially semispherical shape; and wherein, preferably, the upper piece (103) comprises a peripheral internal thread (108) adapted to engage a corresponding external thread (109) provided on the module frame (101 ).

10. The portable module according to any of claims 3 or 6, wherein the sensor is a temperature sensor adapted to measure a temperature on the second surface (101 b) of the module frame; or wherein the sensor is a motion and/or acceleration sensor adapted to measure a displacement and/or acceleration imparted on the second surface (101 b) of the module frame.

1 1 . The portable module according to claim 1 , wherein the module frame (201 , 301 ) comprises:

a main body (208, 305) having a surface (204, 304) adapted to receive the cylindrical surface of the barrel (2) of the syringe; and

a positioning element (202, 302) connected to the main body (208, 305) and adapted to receive the end of the barrel (2) proximate to the needle hub (5) and to prevent the displacement of the main body (208, 305) towards the opposite end of the barrel along its longitudinal direction when the portable module is attached to the syringe.

12. The portable module according to claim 1 1 , wherein the positioning element (202) comprises an annular portion (203) adapted to surround at least partially the end of the barrel (2) proximate to the needle hub (5) when the portable module is attached to the syringe, said annular portion (203) having an inner diameter smaller than the diameter of the barrel but larger than the diameter of the needle hub.

13. The portable module according to claim 1 1 , wherein the positioning element (302) comprises two flat tabs (302a, 302b) that protrude from the main body (305); and wherein the flat tabs (302a, 302b) are adapted to contact the end of the barrel (2) proximate to the needle hub (5) at opposite sides of the needle hub when the portable module is attached to the syringe.

14. The portable module according to any of claims 1 1 to 13, wherein the sensor (303) is arranged on said surface (304) of the main body adapted to receive the cylindrical surface of the barrel (2), and proximate to the positioning element (302).

15. The portable module according to any of claims 1 1 to 13, wherein the module frame (201 ) comprises two side portions (205a, 205b) facing each other and each having an end arranged proximate to the positioning element (202); wherein the side portions (205a, 205b) are connected to the main body (208) such that, when the portable module is attached to the syringe, the side portions (205a, 205b) are placed on two opposite sides on the cylindrical surface of the barrel (2); and wherein the sensor comprises a first sensor element (206a) provided on one of the two side portions (205a), and a second sensor element (206b) provided on the other side portion (205b).

16. The portable module according to claim 15, wherein the first and second sensor elements (206a, 206b) are provided, respectively, on said ends of the side portions (205a, 205b).

17. The portable module according to claim 15 or 16, wherein the first sensor element is an optical transmitter and the second sensor element is an optical receiver operatively coupled to the optical transmitter.

18. The portable module according to claim 15 or 16, wherein the first sensor element is an optical transceiver comprising a transmitter and a receiver; and wherein the second sensor element is a passive optical element that redirects the light emitted by the transmitter of the optical transceiver to the receiver of the optical transceiver.

19. The portable module according to any of claims 1 1 to 18, wherein the attachment means comprises a member (207) adapted to be clipped to the barrel (2) of the syringe.

20. The portable module according to claim 1 , wherein the module frame (401 ) is shaped as a plunger comprising a rod (406) that extends between a first end (406a) and a second end (406b), the second end having a plunger top (402); wherein the attachment means (403) are provided on the first end (406a) of the rod and are adapted to be mechanically coupled, preferably by screwing, to the plunger seal (6); wherein the rod (406) comprises a cylindrical casing (407) in which the control unit is housed; and wherein the sensor (404) is provided on said rod (406).

21 . The portable module according to claim 20, wherein the sensor (404) is either a force sensor adapted to measure a force applied at an end or an intermediate point of the rod (406) of the module frame, or a motion and/or acceleration sensor adapted to measure a displacement and/or acceleration imparted on the rod (406) of the module frame.

22. The portable module according to claim 20 or 21 , further comprising a second sensor (405) operatively connected to the control unit; wherein the sensor (404) is arranged proximate to the first end (406a) of the rod; and wherein the second sensor (405) is arranged on the plunger top (402).

23. The portable module according to claim 22, wherein the second sensor (405) is a force sensor adapted to measure a force applied on the plunger top (402), or a temperature sensor adapted to measure a temperature on the plunger top (402).

24. The portable module according to any of claims 1 to 21 , wherein the control unit is adapted to store the measurements provided by the sensor (206a, 206b; 303) with a predetermined periodicity and to determine that the plunger seal (6) has reached the end of the barrel (2) when a sequence of stored measurements matches a target sequence.

25. The portable module according to claim 22 or 23, wherein the control unit is adapted to store the measurements provided by the sensor (404) and the second sensor (405) with a predetermined periodicity and to determine that the plunger seal (6) has reached the end of the barrel (2) when a first sequence of stored measurements provided by the sensor (404) matches a first target sequence and a second sequence of stored measurements provided by the second sensor (405) matches a second target sequence.

26. The portable module according to claim 24 or 25, wherein said predetermined periodicity is between 5msec and 20msec.

27. The portable module according to any of the preceding claims, further comprising activation means operatively coupled to the attachment means; wherein the activation means are configured to activate the control unit when the module frame is attached to the syringe.

28. The portable module according to claim 27, wherein the activation means comprises an activation sensor adapted to detect a strain or a mechanical pressure exerted on the attachments means.

29. The portable module according to any of the preceding claims, further comprising a power management module (504) to energize the control unit, the communication unit, the attachment means and/or the sensor.

30. The portable module according to any of the preceding claims, wherein the control (501 ) unit comprises a processing module (506) and a memory module (507).

31 . The portable module according to claim 30, wherein the control unit (501 ) is configured to store infusion data in the memory module (507) every time the control unit determines that the plunger seal has reached the end of the barrel proximate to the needle hub.

32. The portable module according to claim 31 , further comprising a geolocalization unit (505) arranged in the module frame and operatively connected to the control unit (501 ); and wherein the control unit (501 ) is configured to include a geolocalization stamp in the infusion data stored in the memory module (507).

33. The portable module according to claim 31 or 32, wherein the control unit (501 ) further comprises a clock module (508); and wherein the control unit (501 ) is configured to include a time stamp in the infusion data stored in the memory module (507).

34. The portable module according to any of claims 31 to 33, wherein the control unit (501 ) is configured to include an identification code unique to said portable module (500) in the infusion data stored in the memory module (507).

35. The portable module according to any of the preceding claims, wherein the communication unit (502) is configured to implement one or more of the following wireless communication standards: 2G, 3G, or 4G cellular communication standards, Wi-Fi, Bluetooth, or ZigBee.

36. The portable module according to any of the preceding claims, wherein the control unit comprises means to switch across a plurality of operation modes, said plurality of operation modes including a normal operation mode, a configuration mode, a stand-by low power consumption mode and a power-level indication mode.

37. System (800) for monitoring the administration of medication, comprising:

one or more portable modules (100, 200, 300, 400, 500, 806) for detecting an infusion of the contents of a syringe according to any of the preceding claims; and

a remote back-office server (801 );

wherein the one or more portable modules are configured to communicate with the remote back-office server to transmit information relative to the infusion of the medication contained in the syringe.

38. The system according to claim 37, further comprising a user terminal (808) through which the one or more portable modules (100, 200, 300, 400, 500, 806, 807) communicate with the remote back-office server (801 ), and wherein the user terminal (808) is additionally configured to exchange patient information data with the remote back-office server (801 ).