Patent Description:
The present invention concerns also a system for extracting and collecting a sample of a fluid of a patient, e.g. blood, in particular capillary blood, comprising a sample collection device. Such an electronic module and such a system are known from <CIT>.

Venipuncture is a blood collection method where the vein is punctured by a hollow needle, and where blood is collected into a tube. This method allows collection of large and high quality blood samples into tubes. Several tubes can be filled during one blood sampling. Furthermore, these tubes are compatible with highly automated blood analyzers, which can analyze thousands of samples per day. These high throughputs capabilities answer the growing need to fast and clinical grade diagnostics at the lowest cost.

However, this method requires a healthcare professional (e.g. a nurse) with a specific qualification further than a dedicated infrastructure. Moreover, risks are associated with puncturing the vein: if the vein is fragile or if the gesture is not performed properly, it can result in a hematoma. There is also a risk of needle-stick injury, which may expose the healthcare professionals to blood-borne diseases.

On the other hand, the finger prick method consists in the incision of the skin at the fingertip using a lancet. A drop or a few drops of capillary blood can be collected into capillary tubes or into dedicated analytical devices (e.g. microfluidic devices, lab-on-chip, paper-based diagnostic tools,. While this technique does not require highly trained professional and can be performed by the patient himself, it is very difficult to collect blood above <NUM>µl and to perform many analyses per sample.

Moreover, the blood collected into glass capillaries or through other devices, cannot be analyzed by automated analyzers, used by central laboratories, which require to have a minimum dead volume of blood of <NUM>µl to <NUM>µl contained into a single tube.

In some instances, more blood, up to <NUM>, can be collected with the finger prick method. However, this requires to press and squeeze the finger in order to collect more blood. Squeezing too hard may result in hemolysis (damage of the red blood cells) and dilution of the blood sample by the interstitial fluid, contained in spaces between the tissue cells. For these reasons, and to keep a good blood quality, the use of finger prick is generally limited to the collection of small volumes of blood.

An improved system allowing simplifying collection of a fluid of a patient (e.g., blood) while keeping a high-quality standard for its analysis is known from <CIT>, filed in the name of the same applicant. Said known extraction and collection system includes a first suction pack and a second suction pack, the first suction pack being arranged to be received by the second suction pack. Accordingly, a first chamber is defined between the first suction pack and the second suction pack, said chamber being placed under vacuum (e.g., in a manufacturing assembly line or in a healthcare facility). The second suction pack comprises a button, formed on one of its outer surfaces, and a piercing protrusion which is located below the button such that, once a user activates the button, the piercing protrusion pierces a membrane (e.g., an Aluminum membrane) provided in the first suction pack, thereby transferring the vacuum from the first vacuum chamber to a second chamber (i.e., a collection chamber).

However, in such a system, the user has to proactively stop collection of the fluid (e.g., blood) by detaching the system from a collection site on the skin of a patient.

In order to facilitate the user in monitoring blood collection progress, the second suction pack is formed of a transparent material and provided with filling lines.

Upon visually determining that a required amount of fluid for analysis has been collected, the user detaches the system from the collection site on the skin of the patient to stop fluid collection.

In case fluid collection is not stopped before the amount of collected fluid (e.g., blood) exceeds a certain amount, overflow and leakage of fluid may occur. This increases the risk of fluid spilling and dangerous cross-contamination.

On the other hand, in case fluid collection is stopped too soon, the amount of collected fluid can be insufficient for performing analysis.

An aim of the present invention is to propose an electronic element for a sample collection device allowing automatically and reliably detecting when a required amount of fluid for analysis is collected in a sample collection device.

According to the invention, these aims are achieved by means of an electronic module according to the attached independent claim <NUM>.

In particular, an electronic module for a sample collection device is provided, the electronic module at least comprising:.

The invention is based on the basic idea that, by measuring in real time the volume of collected fluid (e.g., blood) and providing a warning signal to the user when it is determined that a predefined amount of fluid has been collected, the user is enabled stopping fluid collection at an appropriate moment, thereby preventing occurrence of fluid overflow and leakage, at the same time ensuring that the collected amount of fluid is sufficient for performing analysis.

When properly used, the electronic module is not contaminated by blood. Thus, the electronic module can be reusable.

The electronic module is configured to be attached to, respectively detached from, the sample collection device.

The electronic module comprises a casing and a protruding body, formed on a surface of the casing.

The protruding body includes an activation button for operating a switch that activates the electronic module.

The protruding body includes a window for the arrangement of the measurement system.

The measurement system may comprise one or more sensors, preferably one or more optical sensors.

The casing and the protruding body can be formed in one piece through injection molding.

The protruding body may be eccentrically located on the surface on which it is formed. The electronic module may further comprise one or more of a battery, a microcontroller, an embedded firmware, and a communication unit for communicating with one or more external devices.

The communication unit is preferably a wireless communication unit.

The means for providing a warning signal may comprise an acoustic indicator and/or a visual indicator.

The visual indicator may comprise a light emitting unit, preferably a LED light emitting unit.

Accordingly, the user can be promptly warned when the required amount of fluid necessary for analysis has been collected, and fluid collection shall therefore be stopped.

The electronic module may further include a cover.

The visual indicator can be provided on the cover.

The cover may be circular in cross-section, and the visual indicator may be formed in the shape of a ring extending around the circumference of a main body portion of the cover.

The electronic module may further comprise means (e.g. sensors) for direct blood analysis.

The present invention further provides a system for extracting and collecting a sample of a fluid of a patient according to the attached independent claim <NUM>. Specifically, the system at least comprises:.

The sample collection device comprises an outer shell comprising a pocket configured for housing the protruding body of the casing of the electronic module. The protruding body and the pocket may be configured to have complementary asymmetrical shapes.

Accordingly, incorrect insertion of the protruding portion inside the pocket can be prevented.

The pocket may be configured to have rounded edges.

Furthermore, the pocket is equipped with an activation element, for example a pin. The activation element, e.g. the pin can be configured and arranged such that it activates the electronic module and especially the sensor, when the electronic module is inserted into the pocket.

The rounded edges provide guidance to the user and allow smooth insertion of the protruding body into the pocket.

Protruding portions can be formed on opposite sides of the pocket, and corresponding undercuts may be formed on a respective external surface of opposite sides of the protruding body, to allow snap fitting of the electronic module into the pocket.

The outer shell of the sample collection device can be made of a optically transparent material.

The invention will be better understood with the aid of the description of an embodiment given by way of example and illustrated by the figures.

<FIG> shows a front view of a system <NUM> for extracting and collecting a sample of a fluid of a patient equipped with an electronic module <NUM> according to one embodiment of the invention.

<FIG> shows a side view of the system of <FIG>.

<FIG> shows a perspective view of the system of <FIG>.

<FIG> show different views of a system <NUM> for extracting and collecting a sample of a fluid of a patient according to an embodiment of the present invention.

The system <NUM> is equipped with an electronic module <NUM>.

Further, the system <NUM> comprises a sample collection device <NUM>.

The sample collection device <NUM> is provided for collection of a sample of a fluid, in particular a bodily fluid, e.g. blood, in particular capillary blood.

The electronic module <NUM> is detachable. It can be reused.

Further, it is possible that the electronic module can be mounted to the sample collection device <NUM> with a snap-fit mechanism as described below.

<FIG> shows a perspective view of an electronic module <NUM> according to an embodiment of the invention, seen from a front side.

<FIG> shows a perspective view of the electronic module <NUM>, seen from a back side.

<FIG> shows an exploded view of the electronic module <NUM>.

As illustrated in <FIG>, the electronic module <NUM> comprises a measurement system <NUM> for measuring a volume of collected fluid (e.g., blood) of a patient in real time, and determining when a predefined amount of fluid for analysis has been collected.

Furthermore, the electronic module <NUM> includes means for providing a warning signal to a user when it is determined that the predefined amount of fluid has been collected.

For example, the means for providing a warning signal may comprise an acoustic indicator <NUM> such as a buzzer (<FIG> and <FIG>).

Additionally or alternatively, the means for providing a warning signal may comprise a visual indicator <NUM> (cf. <FIG>) provided with a light emitting unit, preferably a LED light emitting unit (status LED) <NUM> (see. <FIG> and <FIG>).

Conveniently, in the present embodiment, the electronic module <NUM> is reusable.

<FIG> shows the electronic module <NUM> and a detail of an outer shell of a sample collection device <NUM>, provided with a pocket.

Specifically, the electronic module <NUM> is configured to be attached to, respectively detached from, the sample collection device <NUM> (see <FIG>).

In the shown embodiment, the electronic module <NUM> further comprises a casing <NUM>.

As shown in <FIG>, a protruding body <NUM> is formed on a surface <NUM> of the casing <NUM>.

<FIG> shows a detail of an undercut formed on an external surface of a side of the protruding body <NUM>, formed on the casing <NUM> of the electronic module <NUM>.

<FIG> shows a detail of the pocket <NUM> formed on the outer shell <NUM> of the sample collection device <NUM> as a part of the snap-fit mechanism.

In particular, in the pocket <NUM> as part of the snap-fit mechanism protruding portions <NUM> are formed on opposite sides of the pocket <NUM>.

The protruding portions <NUM> can be provided by protruding ribs or any other suitable structure.

The pocket <NUM> is equipped here with an activation element <NUM>, here in the form of a pin <NUM>. The pin <NUM> is configured and arranged such that it activates the electronic module <NUM> and especially measuring system (e.g. here the sensor), when the electronic module <NUM> is inserted into the pocket.

The protruding body <NUM> comprises an activation button <NUM>, for operating a switch <NUM> (e.g., a mechanic switch) that activates the electronic module <NUM>.

When the electronic module <NUM> is inserted into the pocket <NUM>, then the pin <NUM> engages with the activation button <NUM> and this way the electronic module is activated.

Additionally, the protruding body <NUM> comprises a window <NUM> for the arrangement of the measurement system <NUM>.

The window <NUM> may be provided with a window overlay <NUM> (see <FIG>).

The window overlay <NUM> can be connected to the window <NUM> through an adhesive layer (e.g., and adhesive film) <NUM> (see also <FIG>).

The measurement system <NUM> includes one or more sensors, preferably one or more optical sensors.

The sensors can be advantageously arranged within support and protection means <NUM>, for instance made of foam (<FIG>).

<FIG> shows a block diagram showing components of the electronic module <NUM> and how the components are related and connected to each other.

<FIG> shows a front view of a PCB assembly of the electronic module <NUM>, seen from a front side.

<FIG> shows a perspective view the PCB assembly of <FIG>, seen from a back side.

<FIG> shows a flow diagram showing interaction between the components of the electronic device during a fluid collection process.

<FIG> shows a diagram showing optical properties of blood, here the absorption spectrum of human blood.

The sensors (known in the state of the art), may be selected based on the optical properties of blood, shown in the diagram of <FIG>.

The sensors are configured to perform blood volume measurement.

The sensor on the PCB could be adapted to also detect the type of device (e.g. yellow cap, purple cap,. , wherein the color indicated the type of measurement, which can be done with the electronic module) and adjust the collection parameters according to the type of the device.

The electronic module <NUM> can be further configured for direct blood analysis.

To this end, means for performing blood analysis such as direct blood analysis sensors can be provided in the electronic module <NUM>.

In the shown embodiment, the electronic module <NUM> includes a battery <NUM>.

The battery can be exchanged. It is possible that the user can exchange the battery. It is also possible that the housing of the electronic module is sealed, so that the exchange of the battery can be done by the manufacturer.

The battery <NUM> can be a coin cell, e.g. a CR2032 coin cell as in the shown embodiment. However, any other type of battery (either rechargeable or not rechargeable) may be used. Also, any other type of power source like a solar cell or the like is possible.

Moreover, the electronic module <NUM> includes a microcontroller <NUM>.

The battery <NUM> and the microcontroller <NUM> are arranged on a PCB assembly <NUM> provided in the electronic module <NUM> (<FIG> and <FIG>-11B).

The electronic module <NUM> of the present embodiment is further provided with an embedded firmware.

Still further, the electronic module <NUM> comprises a communication unit, preferably a wireless communication unit, more preferably a Bluetooth® communication unit, for communicating with one or more external devices (not shown). Other communication possibilities and standards can also be used, such as WiFi, Zigbee and the like.

An exemplary architecture of the electronic module <NUM> is shown in <FIG>.

In the example of <FIG>, the electronic module <NUM> includes a sensor PCB <NUM>.

The measurement system <NUM> is included in the sensor PCB <NUM>.

In the present configuration, the measurement system <NUM> is provided with a pair of photodiodes <NUM>.

The source LED <NUM> is (operatively) connected to the microcontroller <NUM>.

The sensor PCB <NUM> is (operatively) connected to the microcontroller <NUM>.

The sensor PCB <NUM> may be further connected to a multiple wavelength and/or infrared emitter and detector unit <NUM>.

The electronic module <NUM> further includes an accelerometer <NUM>, operatively connected to the microcontroller <NUM>.

The accelerometer <NUM> allows to identify the correct orientation of the device. In particular, which accelerometer <NUM> acceleration data can be retrieved, which allow to identify, whether the device is upside down or nor and to make a volume compensation, if the device is tilted. If the device is used upside down, the accelerometer detects it and may emit a sound and/or light signal to warn the user before activation of the device.

The electronic module <NUM> further includes the switch <NUM>, operatively connected to the microcontroller <NUM>.

The switch <NUM> is operated through the operating button <NUM>, so as to turn on/off the electronic module <NUM>.

The microcontroller <NUM> controls operation of the LED light emitting unit <NUM> to emit a light signal to warn the user when it is determined that a predefined amount of fluid for analysis has been collected.

Similarly, the microcontroller <NUM> controls operation of the acoustic indicator (piezoelectric buzzer <NUM>), to emit a warning signal to warn the user when it is determined that a predefined amount of fluid for analysis has been collected.

The electronic module <NUM> may further include an antenna <NUM>.

Still further, the electronic module <NUM> may include an antenna filter <NUM> (<FIG>).

An algorithm <NUM> is implemented in the microcontroller <NUM> for controlling operation of the different components of the electronic module <NUM>.

As shown in <FIG> and <FIG>, the sensor PCB <NUM>, the source LED <NUM>, the microcontroller <NUM>, the accelerometer <NUM>, the antenna <NUM>, the antenna filter <NUM>, the switch <NUM>, the acoustic indicator (piezoelectric buzzer <NUM>), and the LED light emitting unit <NUM>, are arranged on the PCB assembly <NUM>.

An example of the interactions between the different components of the electronic module <NUM> in a fluid collection process is shown in the flowchart of <FIG>.

The electronic module <NUM> is activated by operating the switch <NUM> via the operating button <NUM> (S100).

Then, it is determined whether a battery is in a good status or not (S101).

If the battery is not in a good status, the process is ended (S112).

If the battery is in a good status, the source LED <NUM> is turned on (S102).

Then, an output of the pair of photodiodes (optical sensors) <NUM> is read by the microcontroller <NUM> (S103).

Then, the source LED <NUM> is turned off (S104).

After the source LED <NUM> is turned off, it is determined whether the output of both photodiodes <NUM> is high (S105).

If the output of both the photodiodes <NUM> is high, the process returns to step S102.

If the output of both photodiodes <NUM> is not high, it is determined whether the output of one of the photodiodes <NUM> is low (S106).

If the output of one of the photodiodes <NUM> is low (and the other sensor output is high), the process returns to step S102.

If the output of both of the photodiodes <NUM> is low, the microcontroller <NUM> processes data from the accelerometer <NUM>, and performs calibration based on the processed data (S107, S108).

After performing calibration (S107) and determining that the output of both photodiodes <NUM> is low (S108), the piezoelectric buzzer <NUM> and the LED light emitting unit <NUM> are turned on (S109).

Then, the electronic module <NUM> is switched to a low power mode (S110).

Finally, the electronic module <NUM> is switched off and the process is ended (S112).

When the electronic module <NUM> is switched off and the process is ended (S112), the user can separate the electronic module <NUM> from the sample collection device <NUM> for further use.

Advantageously, data from the electronic module <NUM> can be transmitted to an external device (not shown) via the communication unit (preferably a wireless communication unit, more preferably a Bluetooth® communication unit) (S111) before the electronic module <NUM> is turned off and the fluid collection process is ended (S112).

The electronic module <NUM> is capable of performing its functions with low energy consumption.

The electronic module <NUM> further includes a cover <NUM>.

Specifically, in the shown embodiment, the cover <NUM> is circular in cross-section (<FIG> and <FIG>).

In the shown embodiment, the visual indicator <NUM> is provided on the cover <NUM>.

Specifically, as shown in <FIG>, the visual indicator <NUM> is formed in the shape of a ring extending around the circumference of a main body <NUM> portion of the cover <NUM>.

In the shown embodiment, the PCB assembly <NUM> is sandwiched between the casing <NUM> and the cover <NUM> (<FIG>).

A plurality of LED light emitting units <NUM> are arranged on a front side of the PCB assembly <NUM> to illuminate the ring-shaped visual indicator <NUM> (<FIG>).

The ring-shaped visual indicator <NUM> is preferably made of a translucent material.

An O-ring <NUM> may be interposed between the cover <NUM> and the casing <NUM> (<FIG>).

As an alternative, instead of providing the O-ring <NUM>, an overmolding can be formed on the cover <NUM>.

In the shown embodiment, the protruding body <NUM> is eccentrically located on the surface <NUM> on which it is formed (<FIG>).

Advantageously, the casing <NUM> and the protruding body <NUM> can be formed in one piece through injection moulding.

The sample collection device <NUM> comprises an outer shell <NUM> (as shown in <FIG>).

In the shown embodiment, the outer shell <NUM> comprises a pocket <NUM> (see <FIG>), configured for housing the protruding body <NUM> of the casing <NUM> of the electronic module <NUM>.

The protruding body <NUM> and the pocket <NUM> are configured to have complementary asymmetrical shapes.

Accordingly, the protruding body <NUM> can only be inserted into the pocket <NUM> in one direction.

Thus, incorrect insertion of the protruding body <NUM> into the pocket <NUM> can be prevented.

In the shown embodiment, the pocket <NUM> has rounded edges <NUM> (see <FIG>).

The rounded edges <NUM> provide guidance to the user during insertion of the protruding body <NUM> into the pocket <NUM>.

Further, in the shown embodiment, protruding portions <NUM> are formed on opposite sides of the pocket <NUM> (see <FIG>), and complementary undercuts <NUM> are formed on a respective external surface <NUM> of opposite sides of the protruding body <NUM> (see <FIG>).

This allows easily and reliably coupling the protruding body <NUM> and the pocket <NUM> through snap-fitting (see <FIG>).

Advantageously, the outer shell <NUM> of the sample collection device <NUM> can be made of a transparent material to enable the user visually monitoring a blood collection progress.

Claim 1:
An electronic module (<NUM>) for a sample collection device (<NUM>), comprising:
a measurement system (<NUM>) for measuring a volume of collected fluid of a patient in real time and for determining when a predefined amount of fluid has been collected, and
means for providing a warning signal to a user when it is determined that the predefined amount of fluid has been collected,
wherein
the electronic module (<NUM>) further comprises a casing (<NUM>) and a protruding body (<NUM>) that is formed on a surface (<NUM>) of the casing (<NUM>) for attaching to, respectively detaching from, the sample collection device (<NUM>), thereby providing for a reusable electronic module (<NUM>), characterised in that
the protruding body (<NUM>) comprises an activation button (<NUM>) for operating a switch (<NUM>) that activates the electronic module (<NUM>), and a window (<NUM>) for the arrangement of the measurement system (<NUM>).