Patent Description:
In the field of transfusion medicine, but also in the administration of drugs by intravenous infusion, the use of special bags is known which can be connected to infusion means, such as e.g. needles, for the infusion of their contents into the bloodstream of a patient.

In particular, in the specific case of blood components, the bags are previously provided with mixtures of anticoagulants and preservative solutions adapted to preserve the vitality and functionality of blood cells. Once filled, in the so-called blood banks, the bags are stored at refrigerated temperatures for more than one month or can be frozen for longer periods.

At the time of use, bags must be transported under refrigerated conditions from the blood bank to a destination facility in order to preserve the above characteristics until infusion. It is easy to understand that interruptions in the cold chain, even if of short duration, can lead to alterations in the contents of the bags.

For this reason, it is well known to use bags provided with temperature sensors, able to detect and monitor the temperature values to which each bag is subjected.

Such bags are generally made with a sensor built into them and, once used, are disposed of together with the sensor itself.

It is clear, therefore, that this solution is decidedly impractical and expensive compared to traditional bags and can involve very high costs for the facilities responsible for the collection. Not least, according to current regulations, the blood component bags must necessarily be disposed of as special waste. The electronic components, which make up the sensors associated with them, cannot, therefore, be properly differentiated, with a consequent high environmental impact.

In addition, the sensors used are not capable of detecting other physical entities or other identifying data useful in correctly associating the bag with a particular patient.

In this regard, it is clear that it is of paramount importance that the bags are delivered to the correct patient. In fact, administering blood types to an incompatible patient can be fatal.

In addition, doubts about the origin of the bag, the conditions to which it was subjected during transport, or the patient for whom it is intended may require disposal of the bag prior to use.

These issues are partially overcome by the monitoring system described in document <CIT>.

<CIT> describes a monitoring system for biological products provided with a sensing device configured to record bag temperature values and identifying data such as identifying data about the bag, its contents, the destination transfusion center, the assigned patient, and the like.

At the time of the blood component collection, the sensing device is inserted into a special pocket formed in the bag, or applied to the bag by adhesive means and, following patient administration, it is removed before disposal for reuse. The monitoring system described by <CIT> does however have some drawbacks.

In fact, such a monitoring system does not ensure secure bag tracking. The sensing device may accidentally fall out of the pocket or be removed, or it can be applied to a different bag without any possibility for the operator to notice it. It follows that the aforementioned system does not allow monitoring in an unequivocal way the environmental conditions to which the bag is subjected, nor does it allow verifying that the bag is intended for a specific patient, with the risk of incurring the problems discussed above.

Documents <CIT>, <CIT> and <CIT> disclose devices forming part of the close prior art.

The main aim of the present invention is to devise a monitoring system of blood component bags which allows a blood component bag to be unambiguously monitored and which ensures proper and safe association between the bag itself and a sensing device.

Another object of the present invention is to devise a monitoring system for blood component bags which will also detect temporary removal of the sensing device from the respective bag.

Still one object of the present invention is to devise a monitoring system for blood component bags which allows detecting a plurality of different environmental conditions to which the bag is subjected.

Another object of the present invention is to devise a monitoring system for blood component bags which allows overcoming the aforementioned drawbacks of the prior art within a simple, rational, easy and effective to use as well as affordable solution.

The aforementioned objects are achieved by the present monitoring system of blood component bags having the characteristics of claim <NUM>.

Other characteristics and advantages of the present invention will become more apparent from the description of a preferred, but not exclusive, embodiment of a monitoring system of blood component bags, illustrated by way of an indicative, yet non-limiting example, in the accompanying tables of drawings wherein:.

With particular reference to these figures, reference numeral <NUM> globally indicates a monitoring system of blood component bags.

The monitoring system <NUM> comprises at least one sensing device <NUM> comprising at least one temperature sensor <NUM> configured to detect at least one value of temperature of at least one bag S containing blood components.

In the present discussion, "bag" means a container consisting of a pair of sheets of polymeric material welded together around their perimeter edges to obtain an internal cavity, in which a product for intravenous infusion is inserted, in this case blood or blood components. It cannot, however, be ruled out that the present monitoring system may be applied to bags for the containment and transport of drugs for intravenous infusion or bags of different types.

The sensing device <NUM> is movable with respect to the bag S between an operating position, wherein it is positioned at the point where the bag S is located and wherein the temperature sensor <NUM> detects the value of temperature, and a far-away position, wherein it is moved away from the bag S.

The sensing device <NUM> is associable in a removable manner with the bag S so that it can be reused several times as a result of the infusion operations of the bag contents.

According to the invention, the monitoring system <NUM> is also provided with:.

The support <NUM> comprises a transit opening <NUM> adapted to allow the insertion/extraction of the bag S into/from the support itself.

More in detail, according to a preferred embodiment, the support <NUM> comprises at least two opposite and mutually associated walls <NUM>, preferably by interlocking, along their respective side edges to define the housing <NUM> between them. The walls <NUM> comprise at least two corresponding free side edges <NUM> delimiting the transit opening <NUM>.

Substantially, through the transit opening <NUM>, the bag S is positionable in the housing <NUM> and is retained inside the support <NUM> by means of the retaining means <NUM>.

The sensing device <NUM> is associable with the support <NUM> in a removable manner. Furthermore, the sensing device <NUM> comprises at least one contact sensor <NUM> configured to detect the positioning of the sensing device <NUM> in the operating position.

The contact sensor <NUM> allows sensing and recording any removal of the sensing device <NUM> from the support <NUM> so as to ensure proper traceability of the bag S.

In this case, the contact sensor <NUM> is of the type of, e.g., a pressure sensor. Again, in the operating position, the sensing device <NUM> is configured to lock the retaining means <NUM> in the closed configuration.

In other words, when the sensing device <NUM> is associated with the support <NUM>, in its own seat <NUM>, the retaining means <NUM> cannot be moved to the open configuration and the bag S cannot be removed from the support. The removal of the sensing device <NUM> to allow extraction of the bag S is readily detected by the contact sensor <NUM>.

The retaining means <NUM> comprise a retaining element <NUM> movable with respect to the support <NUM> between the open configuration and the closed configuration.

In detail, in the closed configuration, the retaining element <NUM> is shaped so as to at least partly obstruct the transit opening <NUM>.

In the embodiment shown in the figures, the retaining element <NUM> is of a substantially elongated conformation.

The retaining element <NUM> is positionable to be arranged between the free side edges <NUM> so as to prevent the transit of the bag S through the transit opening <NUM>. Conveniently, the support <NUM> comprises an abutment portion <NUM> which is shaped to accommodate the retaining element <NUM> in the closed configuration.

The abutment portion <NUM> is formed in at least one of the walls <NUM> at the point where the free side edge <NUM> is located.

Conveniently, the retaining element <NUM> comprises a first portion <NUM> associated with the support <NUM> and a second portion <NUM>, opposite the first portion <NUM>, shaped to engage with the abutment portion <NUM>, in the closed configuration.

The retaining means <NUM> comprise fastening means <NUM>, <NUM>, of the interlocking type, positioned between the second portion <NUM> and the abutment portion <NUM>.

In more detail, according to a possible embodiment, the fastening means <NUM>, <NUM> comprise a protrusion <NUM> formed on the second portion <NUM> and shaped so as to mate with a corresponding recess <NUM> formed in the abutment portion <NUM>.

The interaction between the protrusion <NUM> and the recess <NUM> results in a firm mating between the retaining element <NUM> and the abutment portion <NUM> and prevents accidental opening of the retaining means <NUM>.

It cannot, however, be ruled out that the fastening means <NUM>, <NUM> may be of a different type, e.g. of the type of a pair of small teeth of complementary conformation to each other.

Advantageously, the retaining element <NUM> is movable in rotation around a relevant axis of rotation R, at the point where the first portion <NUM> is located, between the open configuration and the closed configuration.

In more detail, the axis of rotation R extends parallel to one of the free side edges <NUM> and in the proximity thereof.

The first portion <NUM> is associated with the support <NUM> along the axis of rotation and is rotatable with respect thereto.

By rotating around the axis of rotation R towards the closed configuration, the second portion <NUM> reaches the abutment portion <NUM> and engages with the latter. Advantageously, the seat <NUM> of the sensing device <NUM> is defined at the point where the abutment portion <NUM> is located.

In other words, the seat <NUM> is obtained on the wall <NUM>, on which the abutment portion <NUM> is defined, at the point where the relevant free side edge <NUM> is located.

In the operating position, the sensing device <NUM> is positioned at the point where the abutment portion <NUM> is located to prevent the retaining element <NUM> from rotating from the closed configuration towards the open configuration.

The positioning of the sensing device <NUM> in the seat <NUM> keeps, therefore, the second portion <NUM> engaged with the abutment portion <NUM>.

This makes it impossible to remove the bag from the support <NUM> without first removing the sensing device from the seat <NUM>.

Conveniently, the support <NUM> comprises anchoring means <NUM> of the sensing device <NUM> to the seat <NUM>, of the interlocking type.

In more detail, the anchoring means <NUM> comprise a pair of sliding rails <NUM> formed on the wall <NUM> of the support <NUM> and adapted to fit into corresponding grooves <NUM> formed on the sensing device <NUM>.

In the embodiment shown in the figures, the sliding rails <NUM> extend transversely to the free side edges <NUM>.

The sensing device <NUM> is, therefore, positioned in the seat <NUM> by sliding along the sliding rails <NUM> until it reaches the operating position.

The sensing device <NUM> comprises an enclosure <NUM>, <NUM> provided with a contact wall <NUM> facing a wall of the housing <NUM> at the point where the seat <NUM> is located, in the operating position and an external wall <NUM> facing outwards.

Conveniently, the temperature sensor <NUM> and the contact sensor <NUM> are arranged on the contact wall <NUM>.

In this way, in the operating position, the temperature sensor <NUM> is arranged adjacent to the bag S and the contact sensor <NUM> is activated by the abutment with the wall of the support <NUM>.

Advantageously, the sensing device <NUM> comprises at least one humidity sensor <NUM> configured to detect at least one value of humidity external to the bag S and at least one brightness sensor <NUM> configured to detect at least one value of brightness external to the bag S.

The presence of the humidity sensor <NUM> and of the brightness sensor <NUM> therefore allows sensing additional environmental parameters that could compromise the quality of the product contained in the bag S.

The sensing device <NUM> is capable of periodically recording these values so as to ensure near-constant monitoring.

The sensing device <NUM> also comprises acquisition means <NUM> configured to acquire at least one control datum.

In this case, the control datum is selected out of: an identification control datum of a patient or an identification control datum of at least one caregiver.

Preferably, the acquisition means <NUM> are configured to acquire at least one identification control datum of a patient.

The acquisition means <NUM> allow, therefore, recording at least one datum concerning the patient in order to ensure the correct and quick assignment of the bag S to the patient him/herself.

Conveniently, the acquisition means <NUM> are of the radio frequency type. Preferably, the acquisition means <NUM> are of the NFC (Near Field Communication) type.

The NFC transceiver technology is of a type known to the engineer of the industry and will not be described in detail in the present disclosure.

The monitoring system <NUM> comprises identification means of the NFC type, not shown in detail in the figures, configured to communicate a corresponding control datum to the acquisition means <NUM>.

In this case, the identification means are of the type of a bracelet and/or a badge provided to the receiving facility for the patient and/or caregivers.

The sensing device <NUM> comprises at least one electronic unit <NUM> provided with a memory unit <NUM> configured to store at least one of either a value of temperature, a value of humidity, a value of brightness, at least one control datum or at least one preset datum.

In this case, the preset datum is selected out of: a preset datum identifying the bag S, a preset datum identifying the contents of the bag S, a preset datum identifying a patient, a preset datum identifying a destination of use of the bag S.

Substantially, the sensing device <NUM> allows storing a set of preset data, at the beginning of the monitoring operations of the bag S, and a set of control data, acquired by means of the acquisition means <NUM>, during the transit of the bag S to the patient.

Similarly to the control data, the preset data are also loaded onto the memory unit <NUM> by means of the acquisition means <NUM>.

In more detail, the monitoring system <NUM> comprises loading means, not shown in detail in the figures, configured to communicate the preset data to the acquisition means <NUM>.

The loading means are of the type of an NFC writer.

The memory unit <NUM> is also configured to store values of position detected by the contact sensor <NUM>. In other words, the memory unit <NUM> is able to store any removal of the sensing device <NUM> from the seat <NUM>.

Conveniently, the electronic unit <NUM> comprises a processing unit <NUM> configured to check the matching between the preset datum and a corresponding control datum.

For example, the processing unit <NUM> is configured to compare the identification control datum of the patient receiving the bag S with the corresponding preset identification datum of the patient loaded on the memory unit <NUM> at the beginning of the monitoring operations.

The sensing device <NUM> also comprises indication means <NUM> configured to indicate a result of the check.

In the embodiment shown in the figures, the indication means <NUM> are of the luminous type and comprise one or more LED units, each corresponding to a control datum to be acquired.

The indication means <NUM> may be fixed and/or intermittent light.

It cannot however be ruled out that the indication means <NUM> are of different types. For example, the indication means <NUM> may be of an audible type or both of a luminous and an audible type.

Advantageously, the sensing device <NUM> comprises transmission means <NUM> operationally connected to the memory unit <NUM> and configured to transmit at least one of at least one of the values or at least one of the identification datum to at least one external unit <NUM>.

The sensing device <NUM> allows transferring the acquired data to the external unit <NUM> in order to allow them to be stored on different electronic devices or to carry out an additional control.

According to a preferred embodiment, the transmission means <NUM> are of the Bluetooth type.

In combination or alternatively, the transmission means <NUM> may be of the CAN (Controller Area Network) type.

Bluetooth and CAN technologies are of a type known to the engineer in the industry and will not be described in detail in the present disclosure.

The sensing device <NUM> comprises storage means <NUM> for storing electrical energy which are configured to supply the sensing device <NUM>.

The storage means <NUM> are of the type of a rechargeable battery. Advantageously, the monitoring system <NUM> comprises a charging station <NUM> configured to house at least one sensing device <NUM> and comprising at least electrical charging means <NUM> of the sensing device <NUM>.

In turn, the electrical charging means <NUM> are connectable to an energy source, such as e.g. the power grid.

In the embodiment shown in the figures, the charging station <NUM> is configured to house a plurality of sensing devices <NUM>.

The storage means <NUM> of each sensing device <NUM> comprise connecting elements <NUM> connectable to the electrical charging means <NUM>.

When the sensing device <NUM> is in the charging station <NUM>, the connecting elements <NUM> interact with the electrical charging means <NUM> to enable the transfer of electrical energy.

Conveniently, the charging station <NUM> comprises communication means <NUM> configured to receive at least one of at least one of the values or at least one of the control data from each of the sensing devices <NUM> and to transmit them to the external unit <NUM>.

For this purpose, the transmission means <NUM> are connectable to the communication means <NUM>.

The communication means <NUM> are also configured to acquire the preset data from the external unit <NUM> and to transfer them to the sensing devices <NUM>.

The operation of the monitoring system of blood component bags according to the present invention is as follows.

At the beginning of the monitoring operations, the sensing device <NUM> is arranged in the charging station <NUM>, with the connecting elements <NUM> in contact with the electrical charging means <NUM>.

The bag S is inserted inside the support <NUM>, into the housing <NUM>, the retaining means <NUM> are brought to the closed configuration.

In more detail, the retaining element <NUM> is rotated around the axis of rotation R so that the second portion <NUM> comes into contact with the abutment portion <NUM>. At this position, the curved protrusion <NUM> of the second portion <NUM> engages with the recess <NUM> of the abutment portion <NUM>.

When the sensing device <NUM> is in the seat <NUM>, the retaining means <NUM> cannot be brought to the open configuration again.

The contact sensor <NUM> detects the correct positioning of the sensing device <NUM> in the operating position.

In the event of the sensing device <NUM> being removed from its own seat <NUM>, the contact sensor <NUM> detects this removal and stores it in the memory unit <NUM>.

The sensors <NUM>, <NUM>, <NUM> begin the detection of their respective values and continue for the entire duration of the transit of the bag S towards a receiving facility. The loading means communicate to the sensing device <NUM>, by means of the acquisition means <NUM>, the preset data concerning the bag S, the destination of the bag S and the patient. The preset data are stored on the memory unit <NUM>.

At this point, the bag S, inside the housing <NUM> is transferred towards the receiving facility where the identification means communicate to the sensing device <NUM>, by means of the acquisition means <NUM>, at least one identification control datum of the patient and the processing unit <NUM> checks the correspondence thereof with the relevant preset datum.

The indication means <NUM> indicate to an operator the outcome of such a check, and if successful, the bag S is administered to the patient.

During such operations, the sensing device <NUM> may also acquire and store the control data identifying the caregivers involved.

Upon completion of infusion of the contents of the bag S, the sensing device <NUM> is removed from the support <NUM> to allow the disposal of the bag S.

The sensing device <NUM> is, then, connected to the charging station <NUM> to allow the acquired control data to be transferred and stored by the external unit <NUM>.

It has in practice been ascertained that the described invention achieves the intended objects, and in particular, the fact is emphasized that the present monitoring system allows monitoring a blood component bag, thus enabling the certification of the collected data and ensuring a correct and safe association between the bag itself and a sensing device.

This is accomplished by the operation of the sensing device, in the operating position, in conjunction with the retaining means, in the closed configuration, wherein the bag cannot be removed without the sensing device keeping track of it.

Thus, the monitoring system also allows for the temporary removal of the sensing device from the bag.

Claim 1:
Monitoring system (<NUM>) of blood component bags, comprising at least one sensing device (<NUM>) comprising at least one temperature sensor (<NUM>) configured to detect at least one value of temperature of at least one bag (S) containing blood components, said sensing device (<NUM>) being moveable with respect to said bag (S) between an operating position, wherein it is positioned at the point where said bag (S) is located and wherein said temperature sensor (<NUM>) detects said value of temperature, and a far-away position, wherein it is moved away from said bag (S), wherein the monitoring system comprises:
- at least one support (<NUM>) which is adapted to contain said bag (S) and comprising at least one housing (<NUM>) of said bag (S) and at least one seat (<NUM>) of said sensing device (<NUM>) in said operating position; and
- retaining means (<NUM>) of said bag (S) associated with said support (<NUM>) and positionable between an open configuration, wherein said bag (S) is movable with respect to said housing (<NUM>), and a closed configuration, wherein said bag (S) is retained inside said housing (<NUM>);
characterized by the fact that
said sensing device (<NUM>) comprises at least one contact sensor (<NUM>) configured to detect the positioning of said sensing device (<NUM>) in said operating position and by the fact that, in said operating position, said sensing device (<NUM>) is configured to lock said retaining means (<NUM>) in said closed configuration.