TECHNICAL FIELD

The present invention relates to a detector device for detecting medical items, and related detection method.

BACKGROUND ART

As known, classification and counting systems are commonly used for tracking medical device inventory in operating rooms. In particular, the medical device inventory includes medical items such as gauzes, swabs, scalpel blades, suture needles, implants, tools, and other objects that may be used in a surgical procedure. Tracking surgical or medical device inventory is difficult, and is generally performed by medical staff through visual inspection, at the end of the surgical procedure. Human errors in miscalculating the number of medical items can cause serious health risks. In fact, due to the large number of medical items commonly used within surgical procedures, an error in tracking the medical device inventory could result in leaving a medical item inside an anatomical cavity of the patient's body after the surgical operation is complete. The patient will therefore necessitate a further surgical procedure to remove such medical item, and risk infections, septicaemia and even death if such errors are not detected and treated in due time .

Therefore, classification and counting systems for medical device inventory are used to prevent and avoid such problems. In general, a known classification and counting system includes a container, sensors and counters. The container defines a number of interior cavities adapted to store the medical items (for example, one cavity per each class of medical items) , and a respective number of openings, each one opening to one of the interior cavities. The sensors are coupled to such openings and sense the insertion of each one of the medical items into the interior cavities.

When an operator (such as a surgeon or a member of a medical staff) has made use of the medical items during a surgical procedure, he or she inserts them into the container by passing them through one of the openings. The corresponding sensor senses the insertion of the medical item and transmits a signal to the counter, that updates a counted quantity of the medical items stored in each interior cavity. Information pertaining to the updated quantity of medical items stored in the container are either displayed on a display or stored in a memory included in the classification and counting system.

Because of the medical use, the classification and counting systems must comply with sanitary safe protocols and hygienic requirements. In particular, they must be cleaned, disinfected and sterilized before each use in the operating room. Such operations are onerous both in time and in costs, and need to be carried out by highly trained medical staff. Moreover, the presence of an electronics integrated in the classification and counting systems precludes exploiting usual sterilizing treatments (such as high temperature steam sterilization) , and requires more complex and costly treatments (performed at low temperatures, such as plasma treatment, gamma rays treatment or Ethylene oxide sterilization, EtO) which are scarcely available in hospital facilities.

DISCLOSURE OF INVENTION

The aim of the present invention is to provide a detector device for detecting medical items, and related detection method, overcoming the issues mentioned above.

According to the present invention, a detector device for detecting medical items, and related detection method are provided, as defined in the annexed claims.

BRIEF DESCRIPTION OF THE DRAWINGS

For a better understanding of the present invention, preferred embodiments thereof are now described in a triaxial Cartesian space defined by the reference axes X, Y and Z, purely by way of non-limiting example and with reference to the attached drawings, wherein:

- Figures 1-4 show respective and different views of a detector device, according to an embodiment of the present invention; and

- Figure 5 shows a block diagram describing a method of use of the detector device of Figure 1-4.

BEST MODE FOR CARRYING OUT THE INVENTION

Figure 1 shows a view of a detector device 1 (also indicated as DD 1) according to an embodiment of the present invention.

The DD 1 includes a first housing 3 and a second housing 5, both in the form of containers (having a polyhedron shape, such as a parallelepiped shape) and physically coupled between each other by coupling means 7 (shown in Figure 2). The second housing 5 has lateral walls (not shown and including a joining lateral wall 8) and includes an electronic control module 10 (Figure 4), while the first housing 3 is adapted to host, in an operative condition, medical items 85-88 (shown in Figure 4) such as gauzes, swabs, scalpel blades, suture needles, implants, tools. Moreover, the first housing 3 has a first, a second, a third and a fourth interior side walls 6a-6d (Figure 3), and a bottom wall (not shown) . The first interior side wall 6a is opposed in the first housing 3 to the third interior side wall 6c, and is adjacent to both the second and the fourth interior side walls 6b, 6d, while the second and the fourth interior side walls 6b, 6d are opposed between each other in the first housing 3. Both the first and the third interior side wall 6a, 6c are parallel to an YZ plane, defined by the reference axis Y and Z, while both the second and the fourth interior side walls 6b, 6d are parallel to an XZ plane, defined by the reference axis X and Z .

With reference to Figure 3, the coupling means 7 are shown to include one or more connection elements 17. Each connection element 17 comprises at least one protuberance 19 (in the exemplarily described embodiment, four protuberances 19) , carried by one among the first and the second housing 3, 5 (in the presently described embodiment, jointly connected to the joining lateral wall 8 of second housing 5), and a respective number of seats 21, realized in the other among the first or second housing 3, 5 (in the presently described embodiment, realized in the second interior side wall 6b of the first housing 3) . Therefore, the first housing 3 and the second housing 5 are either jointly connected through the physical coupling of each protuberance 19 with the respective seat 21, or independent between each other when the protuberances 19 are not physically coupled to the respective seats 21. In other words, the first housing 3 and the second housing 5 are either physically coupled in an operating condition, or physically decoupled in a further operating condition. In details, the coupling means 7 can include per se known coupling structures, such as hooks with prismatic coupling.

The first and the second housing 3, 5 are adapted to be covered by a first cover 9 and, respectively, a second cover 11 (Figure 1), included in the DD 1. The first cover 9 has an upper surface and a lower surface (not shown) , and cooperates with the first housing 3 so that the first housing 3 and the first cover 9 are either jointly connected or independent between each other. Moreover, the second cover 11 cooperates with the second housing 5 so that the second housing 5 and the second cover 11 are either jointly connected or independent between each other. In other words, the first housing 3 and the first cover 9 (equivalently, the second housing 5 and the second cover 11) can be physically coupled in a first operating condition (also named closure mode in the following) , or physically decoupled in a second operating condition (also named opening mode in the following) . Such coupling is achieved through per se known coupling methods, such as pressure connections, in dedicated regions of the first housing 3 and the first cover 9 (equivalently, of the second housing 5 and the second cover 11) . Moreover, the first cover 9 includes a plurality of cover openings 27-30 (also named in the following openings 27-30) . In the exemplarily described embodiment shown in Figure 1, the plurality of cover openings 27-30 includes a first cover opening 27, a second cover opening 28, a third cover opening 29 and a fourth cover opening 30, each one having rectangular shape and being parallel one to the other (in particular, each one being perpendicular to a same transversal axis, parallel to the direction of the X axis) . Each cover opening 27-30 has a longitudinal direction along the direction of the Y axis (i.e., a maximum length along the Y axis), and a transversal direction along the direction of the X axis (i.e., a lower length along the X axis). In particular, consecutive cover openings in the plurality of cover openings 27-30 have a fixed and constant relative distance between one another along the X axis.

When physically coupled (i.e., during the closure mode) , the first housing 3 and the first cover 9 internally define a first internal volume 23 (which is thus externally delimited by the first housing 3 and the first cover 9) . Moreover, when physically coupled, the second housing 5 and the second cover 11 internally define a second internal volume 25 (thus being externally delimited by the second housing 5 and the second cover 11) . The cover openings 27- 30 are adapted to make the first internal volume 23 interact with an exterior of the DD 1, thus making the first internal volume 23 an open system and preventing it to be isolated from the exterior of the DD 1. Therefore, they allow mass transfer from the exterior of the DD 1 to the first internal volume 23 and vice versa (for example, they allow the insertion in the first internal volume 23 of medical items 85-88 used in a surgical procedure) . Conversely, the second internal volume 25 is a closed system, and no mass flow occurs between the second internal volume 25 and an exterior of the second housing 5, since the second internal volume 25 is fluidically isolated from the exterior of the second housing 5 (although not electrically isolated, as described later with reference to electrical connections) .

With reference to Figure 2, the first housing 3 is shown to include a number of partition means (in the exemplarily described embodiment, a first, a second and a third partition walls 80-82, of rectangular shape) . Each partition wall 80-82 has an upper edge, a lower edge, a first lateral edge and a second lateral edge (not shown) . The partition walls 80-82 extend in the YZ plane (thus they are parallel between each other) , each of them having the first lateral edge jointly connected to the second interior side wall 6b, and the second lateral edge jointly connected to the fourth interior side wall 6d. Moreover, the lower edge of each partition wall 80-82 is jointly connected to the bottom wall of the first housing 3 and, during the closure mode, each upper edge is in contact with the lower surface of the first cover 9. Each partition wall 80-82 is thus fixed to, and monolithic with, the first housing 3. In the presently described embodiment, a relative distance between consecutive partition walls 80-82 in the first housing 3 is fixed and constant.

The partition walls 80-82 divide the first housing 3 (and thus the first internal volume 23) into a plurality of compartments 33-36 (in Figure 3, a first compartment 33, a second compartment 34, a third compartment 35 and a forth compartment 36) . The first compartment 33 is defined as a portion of the first housing 3 externally delimited by the first interior side wall 6a, the first partition wall 80, a portion of the second interior side wall 6b and a portion of the fourth interior side wall 6d. The second compartment 34 is defined as a portion of the first housing 3 externally delimited by the first partition wall 80, the second partition wall 81, a portion of the second interior side wall 6b and a portion of the fourth interior side wall 6d. The third compartment 35 is defined as a portion of the first housing 3 externally delimited by the second partition wall 81, the third partition wall 82, a portion of the second interior side wall 6b and a portion of the fourth interior side wall 6d. The fourth compartment 36 is defined as a portion of the first housing 3 externally delimited by the third interior side wall 6c, the third partition wall 82, a portion of the second interior side wall 6b and a portion of the fourth interior side wall 6d. During closure mode, each cover opening 27-30 allows a communication (i.e., a matter flow) between one respective compartment 33-36 and the exterior of the DD 1. In particular, the first cover opening 27 faces the first compartment 33 (i.e., it is located at the first compartment 33 and allows an operator to insert medical items 85-88 from the exterior of the DD 1 into the first compartment 33 only), the second cover opening 28 faces the second compartment 34, the third cover opening 29 faces the third compartment 35 and the fourth cover opening 30 faces the fourth compartment 36.

With reference to Figure 3, the second housing 5 further includes at least one sensor supporting opening 37- 40, realized in the joining lateral wall 8. Moreover, the first housing 3 further includes at least one sensor opening 60-63, realized in the second interior side wall 6b. In the presently described embodiment, the joining lateral wall 8 includes a first sensor supporting opening 37, a second sensor supporting opening 38, a third sensor supporting opening 39 and a fourth sensor supporting opening 40, while the second interior side wall 6b includes a first sensor opening 60, a second sensor opening 61, a third sensor opening 62 and a fourth sensor opening 63. Each one of the sensor supporting openings 37-40 faces one respective sensor opening among the sensor openings 37-40 (in particular, each sensor supporting opening and each respective sensor opening are coaxially faced) . In details, the first sensor supporting opening 37 faces the first sensor opening 60, the second sensor supporting opening 38 faces the second sensor opening 61, the third sensor supporting opening 39 faces the third sensor opening 62, and the fourth sensor supporting opening 40 faces the fourth sensor opening 63.

With reference to Figure 4, a sensor apparatus is shown to be further included in the DD 1. According to the presently described embodiment, the sensor apparatus is operatively coupled to the first housing 3, to sense the insertion of medical items 85-88 in the compartments 33-36. In particular, within such embodiment the sensor apparatus is physically coupled to the first housing 3, as better described later, and comprises a plurality of sensors, each one coupled to one respective compartment among the compartments 33-36. Although not limiting of the present invention, in the presently described embodiment the plurality of sensors comprises optoelectronic components, and in particular infrared (IR) optical sensors (such as light emitting diodes, LEDs, operating in the IR range, and coupled to IR photodiodes with matched optical response) . In details, the sensor apparatus includes a first source unit 43, a second source unit 44, a third source unit 45, a fourth source unit 46, a first detector unit 48, a second detector unit 49, a third detector unit 50 and a fourth detector unit 51. The first source unit 43 is carried jointly by both the first sensor supporting opening 37 of the second housing 5 and the first sensor opening 60 of the first housing 3; the second source unit 44 is carried jointly by both the second sensor supporting opening 38 and the second sensor opening 61; the third source unit 45 is carried jointly by both the third sensor supporting opening 39 and the third sensor opening 62; and the fourth source unit 46 is carried jointly by both the fourth sensor supporting opening 40 and the fourth sensor opening 63. The detector units 48-51 are jointly connected to (in particular, fixed to, and monolithic with) the fourth interior side wall 6d of the first housing 3. In particular, each detector unit of the detector units 48-51 lays in one respective compartment among the compartments 33-36 (in other words, each detector unit 48-51 is fixed to the portion of fourth interior side wall 6d facing the respective compartment 33-36) , and is aligned to the respective source unit 43-46 (advantageously, coaxially aligned) , so that a respective light beam (having a respective light path) generated by one of the source units 43-46 is collected by the respective detector unit (extending through the light path) in absence of external medical items 85-88 inserted into the respective cover opening. Moreover, both the detector units 48-51 and the source units 43-46 are placed in contact with the lower surface of the first cover 9, so that the detection performed by the sensor apparatus is only sensitive to the insertion of medical items 85-88, and is independent from the number of medical items 85-88 already present in the compartments 33-36. According to a different embodiment of the present invention, the detector units 48-51 and the source units 43-46 are not placed in contact with the lower surface of the first cover 9. In particular, the location of both the detector units 48-51 and the source units 43-46 in the first housing 3 is chosen so that the detection performed by the sensor apparatus is only sensitive to the insertion of medical items 85-88, and is independent from the number of medical items 85-88 already present in the compartments 33-36.

Furthermore, the second housing 5 is shown to include the electronic control module 10, and therefore the electronic control module 10 and the first housing 3 are movable between a connecting position and a detached position (i.e., when the first housing 3 and the second housing 5 are physically coupled and, respectively, physically decoupled through the connection elements 17) . The electronic control module 10 is jointly connected to the lateral walls of the second housing 5. In particular, the electronic control module 10 is fixed to the lateral walls of the second housing 5 (for example, fixed to the joining lateral wall 8) through per se known fixing techniques, such as plastic bonding or mechanical joining. The electronic control module 10 is a standard IoT ("Internet of Things") technology, implemented in at least one integrated circuit 70. In particular, it includes an elaboration module 72, electrical connections 53-56 and a communication system 74. The electrical connections 53-56, hosted at least partially in the second housing 5, electrically connect the sensor apparatus to the elaboration module 72 (in particular, they connect both the detector units 48-51 and the source units 43-46 to the elaboration module 72, although Figure 4 schematically shown only the electrical connections 53-56 between the source units 43-46 and the elaboration module 72) . The elaboration module 72 includes a control unit (such as a microcontroller or a microprocessor) , an integrated cache memory, a first timer, a second timer, a plurality of counters, a processor memory (for example, a 32-bit Static Random Access Memory, SRAM) and one or more power supply circuits (comprising one or more batteries), electrically coupled between each other. In particular, each counter among the plurality of counters is associated to a respective compartment among the compartments 33-36, to record a number of insertion events in such compartment (i.e., to record a number of medical items 85-88 inserted into such compartment) . Therefore, each counter is adapted to store a respective counter value, indicative of the number of medical items 85-88 inserted in the respective compartment. The elaboration module 72 is adapted to activate the sensor apparatus, to receive sensor output signals from such sensor apparatus and to perform a postprocessing of said sensor output signals, thus generating elaborated output signals, which are representative of the numbers of medical items 85-88 inserted in the respective compartments .

The elaboration module 72 is further configured to control the communication system 74. Advantageously, the communication system 74 is a wireless communication system, including a per se known WiFi module. The communication system 74 is electrically coupled to the elaboration module 72, in order to receive both an electrical activation and said elaborated output signals of the elaboration module 72 as inputs. The communication system 74 includes at least a radio-frequency antenna, an antenna switching circuit, a radio-frequency balun, a power amplifier, a low-noise receiving amplifier and filters. The communication system 74 is configured to perform on said elaborated output signals per se known steps of signal processing (including signal amplification and correction, by means of the power amplifier, the low-noise receiving amplifier the filters) in order to generate transmission signals. Moreover, it is further adapted to transmit said transmission signals through the radio-frequency antenna to an external wireless receiver (included in an external server, which is not included in the DD 1 and thus not part of the present invention) , according to per se known wireless communication protocols. In details, the communication system 74 of the DD 1 communicates (i.e., transfers data strings) with said external sever in HyperText Transfer

Protocol (HTTP) mode, for example through GET, POST or MQTT methods .

In the following section, the working of the DD 1 is described, with reference to Figure 5.

The DD 1 is used for tracking medical device inventory in operating rooms. A step during the fabrication of the DD 1 includes a sterilization procedure through gamma rays irradiation of the DD 1 and a packaging procedure under controlled conditions (in particular, in an environment wherein both the pressure and the concentration in air of micro-organisms are controlled) , to obtain a package including the sterilized DD 1.

In particular, the gamma rays irradiation is a per se known low-temperature sterilization procedure (for example, carried out between 20°C and 25°C), exploiting physical and/or chemical interactions to kill bacteria and pathogen agents by breaking down bacterial DNA and inhibiting bacterial division. The gamma irradiation is an inherently clean process (i.e., it does not create chemical residuals or secondary radioactivity in the medical items 85-88) . A radiation dose to be used during the gamma rays irradiation sterilization procedure depends on the medical items 85-88 to be sterilized and on a desired sterility assurance level (i.e. the probability that a micro-organism survives the sterilization procedure) . According to an embodiment of the present invention, the DD 1 is sterilized at the sterility assurance level of 10 ^~6 .

The packaging procedure includes enclosing the DD 1 in an appropriate package, able to maintain the sterility of the DD 1 until the use of the DD 1. According to an embodiment of the present invention, the package is a peel- open pouche (e.g., self-sealed or heat-sealed plastic and paper pouche) , thus allowing an easy unpacking of the DD 1 in the operating room. According to a further embodiment of the present invention, the package is realized by means of: rigid containers, pouches, roll stock or reels, sterilization wraps. Therefore, the operator (for example, a surgeon or a member of the operating staff) is not required to further perform sterilization procedures before using the DD 1.

A detection process for detecting the insertion of medical items 85-88 in the DD 1 is now described.

In use, the source units 43-46 are configured to emit respective light beams, and the detector units 48-51 are configured to receive the respective light beams emitted by the source units 43-46. In particular, in use the first source unit 43 is adapted to emit a first light beam (not shown) at a first frequency, the second source unit 44 is adapted to emit a second light beam (not shown) at a second frequency, the third source unit 45 is adapted to emit a third light beam (not shown) at a third frequency and the fourth source unit 46 is adapted to emit a fourth light beam (not shown) at a fourth frequency.

The electronic control module 10 is configured to detect the interruption of said respective light paths to detect the number of used medical items 85-88 inserted in the respective compartments 33-36. In details, during the surgical procedure, after each time a medical item 85-88 (such as gauzes, swabs, scalpel blades, suture needles, implants, tools) has been used, such used medical item 85-88 is inserted by the operator into one of the cover openings 27-30. In particular, each cover opening 27-30, and thus each one of the compartments 33-36, is adapted to receive in use a respective kind of medical items 85-88: in the presently described embodiment, the first compartment 33 is configured to host a number of suture needles 85, the second compartment 34 is configured to host a number of scalpel blades 86, the third compartment 35 is configured to host a number of gauzes 87, and the fourth compartment 36 is configured to host a number of swabs 88.

According to an exemplary and not limiting example of operative use of the DD 1, when no suture needle 85 is inserted into the first cover opening 27, the first light beam emitted by the first source unit 37 reaches the first detector unit 48, which consequently generates a first output current having a maximum current value (e.g., equal to about 10 mA) . The first frequency is selected to optimize the optical absorption of the first light beam by the suture needle 85 (i.e., as a frequency at which the optical absorption in the IR range of the suture needle 85 has a maximum value) . In the exemplarily described embodiment, the first frequency is equal to about 330 THz . The first detector unit 48 is adapted to receive and detect the first light beam at the first frequency (i.e., its optical spectral response is optimal at about the first frequency) . In other words, the first output current of the first detector unit 48 has maximum value (i.e., the maximum current value) when the first detector unit 48 detects a light beam (i.e., a radiation) at the first frequency, or in a certain range near the first frequency (in the exemplarily described embodiment, 330120 THz) . The electronic control module 10 is configured to count the number of medical items 85-88 inserted in the each compartment 33-36 of the first housing 3 as a function of a variation of the respective output current caused by the insertion of the medical item 85-88 in the respective opening 27-30. In details, if a suture needle 85 is inserted into the first cover opening 27, the first light beam is at least partially absorbed by the suture needle 85, and is not detected by the first detector unit 48 (or it is only partially detected) . Therefore, the first detector unit 48 generates the first output current having a further current value, lower than the maximum current value. During use of the DD 1, the elaboration module 72 acquires the first output current through the electrical connection 53 and compares it to the maximum current value. If the first output current is lower than a current threshold (which is function of the maximum current value and proportional to it, and in particular is lower than the maximum current value, e.g. equal to 7-10 mA) , the suture needle 85 has been inserted in the first cover opening 27, and thus an insertion event has occurred in the first compartment 33. Therefore, the elaboration module 72 updates the state of a first counter (one counter among the above-mentioned plurality of counters) , associated to the first compartment 33 for recording the number of insertion events in the first compartment 33. In details, the elaboration module 72 updates the state of the first counter by adding one unit (i.e., one insertion event) to the number of insertion events recorded by the first counter .

With reference to figure 5, a method of use of the DD

1 is described, with particular reference to the previously described example concerning the only first compartment 33 (although not limiting of the present invention and valid for each one of the compartments 33-36) .

Before the surgical operation starts, the DD 1 is taken out of its package (not shown because not part of the present invention) : the DD 1 is thus sterile and is advantageously disposed in closure mode (i.e., the first housing 3 and the second housing 5 are covered by the first cover 9 and, respectively, the second cover 11) . Therefore, no medical item 85-88 is present inside any of the compartments 33-36.

According to an embodiment of the present invention, the DD 1 is then switched on (step SO) by means of an on/off button (not shown, and set in the "on" state) , thus starting the electronic control module 10 and setting it into a working mode. According to a different embodiment of the present invention, the DD 1 is switched on (step SO) by removing at least one battery insulating pull tab, coupled to the one or more batteries to prevent them to supply power to the DD 1 and to allow power supply to the DD 1 through the batteries when the battery insulating pull tabs are removed.

In step SI, consecutive to step SO, both the first timer and the second timer are initialized to a reference value (for example, they are set to zero), and are started (i.e., they are activated and they start measuring the elapsing of time from their activation) . Moreover, the plurality of counters is also initialized to a further reference value. In particular, all the counters are set to zero since in such step no medical item 85-88 is already present in the compartments 33-36. Moreover, the communication system 74 establishes a wireless communication with the external sever, according to per se known techniques. In particular, according to an embodiment of the present invention, a registration message is sent by the communication system 74 to the external server in order to register the DD 1 (i.e., to be associated with the DD 1) according to per se known techniques, for example by communicating a unique identification code of the DD 1 to the external server. According to an embodiment of the present invention, the unique identification code is used by the external server to associate the detection events detected by the DD 1 to the specific surgical procedure carried out during the use of the DD 1.

In step S2, consecutive to step SI, both the source units 43-46 and the detector units 48-51 are active and functioning. In particular, the source units 43-46 are emitting the respective light beams, and the detector units 48-51 are receiving the light beams emitted by the source units 43-46.

In step S3, consecutive to step S2, a first time control is performed. In particular, the step S3 verifies if the first timer T ₁ is recording a value which is multiple of a first fixed time period T ₁ , _fix In the presently described embodiment, the first fixed time period T ₁ , _fix is equal to 10 s. Therefore, if the first timer T ₁ is equal to a multiple of such first fixed time period T ₁ , _fix (i.e., if it is equal to 10 s, 20 s, 30 s, 40 s, etc.), the DD 1 is brought into step S8 (exit "Y" of step S3) . Otherwise, the DD 1 is brought into step S4 (exit "N" of step S3 ) .

The step S4 verifies if a second timer T ₂ is recording a second fixed time period T2, _fix . In the presently described embodiment, the second fixed time period T ₂ , _fix is equal to 2 min. If the second timer T2 is equal to the second fixed time period T ₂ , _fix , the DD 1 is brought into step Sll (exit "Y" of step S4). Otherwise, the DD 1 is brought into step S5 (exit "N" of step S4) .

The step S5 verifies if a detection event is occurring in at least one of the compartments 33-36. In particular, the step S5 monitors if a suture needle 85 is inserted into the first cover opening 27. If the first output current is lower than the above-mentioned current threshold, an insertion event has occurred in the first compartment 33 and the DD 1 is brought into step S6 (exit "Y" of step S5) . Otherwise, the DD 1 is brought again into step S2 (exit "N" of step S5 ) .

In the step S6, consecutive to the exit "Y" of the step S5, a value stored in the first counter is updated by adding one unit to the previously stored value, thus obtaining an updated value, representative of the number of suture needles 85 present in the first compartment 33 after the step S5.

In the step S7, consecutive to the step S6, a new- event message is transmitted by the communication system 74 to the external wireless receiver. The new-event message includes an information representative of the updated value of the first counter, and thus of the number of suture needles 85 included in the first compartment 33. The new- event message is adapted to quickly update (i.e., in less than 100ms after the detection event) a status of the external server coupled to the external wireless receiver. Then, the DD 1 is brought again to the step S2.

If the first timer Ti is equal to a multiple of the first fixed time period T ₁ , _fix , the step S8 verifies the state of the on/off button. If the on/off button is set in the "on" state (exit "Y" of step S8) the DD 1 is brought into a step S9. Otherwise (exit "N" of step S8), the DD 1 is brought to the step S4.

In the step S9, consecutive to the step S8, an heartbeat message is transmitted by the communication system 74 to the external wireless receiver. The heartbeat message includes a further information representative of the current value of the first counter, and is adapted to periodically update (i.e., each time the first fixed time period Ti, _fiX elapses, e.g., each 10 s) the number of suture needles 85 in the first compartment 33 recorded by the external server. The heartbeat message is therefore configured to notify to the external server the correct working of the DD 1, and to verify if any discrepancies arise between the number of suture needles 85 recorded by the first counter and the number of suture needles 85 stored in the external server.

In the step S10, consecutive to the step S9, the second timer T2 is re-initialized to the above-mentioned reference value (for example, is set to zero), and is started again (i.e., it starts again measuring the elapsing of time) .

Therefore, if the on/off button is set in the "on" state (i.e., if the DD 1 is working), the heartbeat message is sent to the external server to signal the correct working of the DD 1, and the second timer T2 is re initialized. Conversely, if the on/off button is set in the "off" state (i.e., if the operator switches off the DD 1 because the surgical procedure is finished) , the second timer T2 is not re-initialized and reaches a value equal to the second fixed time period T2, _fix (exit "Y" of step S4) .

In the step Sll, consecutive to the exit "Y" of the step S4, a terminated-process message is transmitted by the communication system 74 to the external wireless receiver, to signal the termination of the working of the DD 1 and the ending of the surgical procedure.

In step S12, consecutive to the step Sll, both the DD 1 and its wireless communication to the external wireless receiver are terminated, and the DD 1 is set in the "off" state .

Furthermore, the wireless communication between the DD 1 and the external server is adapted to implement a voice confirmation process, for enhancing the detection and solution of possible errors caused by the operator in inserting the medical items 85-88 in the cover openings 27- 30.

In particular, when a new-event message is received by the external server, it is memorized, decoded and associated by the external server to a pre-defined audio file, comprising the name of the medical item 85-88 that has been inserted into one of the cover openings 27-30 (for example, the suture needle for the first compartment 33) . The audio file is either previously recorded by the operator in a chosen language, or is generated in real time starting from a text file stored in the external server and including the name of such inserted medical item 85-88, through per se known speech synthesis techniques.

The audio file is then transmitted to a sound reproduction system (not part of the present invention) included in the operating room, to be reproduced and heard by the operator and the medical staff. Advantageously, the text file also includes the number of medical items 85-88 per each compartment 33-36 and a number of medical items 85-88 available in the operating room and not yet inserted into the DD 1 (or, alternatively, the corresponding information limited to the only compartment of the DD 1 interested by such insertion event) .

The operator is expected to either confirm or deny the information included in the text file (also named in the following positive or, respectively, negative operator's feedback) . Such confirmation can be performed by the operator either through a voice confirmation (such as a "yes" voice signal or, respectively, a "no" voice signal, acquired by the external server through a voice recognition system included in the operation room) or by any usual input device (for example, a keyboard, a mouse or a footswitch electrically coupled to the external server) .

If the operator disagrees with the information included in the audio file (i.e., in case of a negative operator's feedback), a warning procedure is started to allow the operator to correct the error. In particular, a warning vocal signal is emitted by the sound reproduction system, and the operator is asked to either manually update the external server (i.e., to correct the number of inserted medical items 85-88 recorded by the external server according to a count performed personally by the operator) , or to rectify the last insertion of the medical item 85-88 (for example, by visually inspecting the DD 1 and removing the medical item 85-88 whose insertion caused the warning procedure) . Nevertheless, an information about the action taken by the operator is recorded in both the external server and the processor memory, so that no data manumission by the operator is possible.

From what has been described and illustrated previously, the advantages of the present invention are evident .

The DD 1 includes IoT technologies and materials having reduced costs, and thus it is used as a disposable device (i.e., at least part of the DD 1 is disposable in the detached position, and in particular at least the first housing 3 is disposable in the detached position) . In other words, at least the first housing 3 is configured to be thrown away after single use, at the end of the surgical procedure (i.e., it is adapted to store the medical items 85-88, and to be thrown away immediately after reaching the step S12 ) .

In particular, the DD 1 is mainly realized in plastic material (besides for the sensor apparatus and the electronic control module 10) , and in particular in polypropylene. The polypropylene is commonly used in medical technologies, because of it has a reduced cost and it can be easily disposed through common hospital waste disposal channels.

Moreover, both the sensor apparatus and the electronic control module 10 are realized through usual "printed circuit board assembly" (PCBA) technologies, by means of processes and materials compliant to the "Restriction of Hazardous Substances" (RoHS) regulations. Furthermore, the DD 1 includes alkaline type batteries, which are easily disposable in hospital structures.

Moreover, the connection elements 17 allow detaching the first housing 3 from the second housing 5. This becomes relevant during the disposing of the DD 1. In fact, the first housing 3 (and the used medical items 85-88 that it hosts at the end of the surgical procedure, i.e. when the DD 1 is switched off in step S12 of Figure 5) follows a disposal process which differs from that one of the second housing 5 (which includes the electronic control module 10) . Since the sanitary and disposing requirements are different between the materials hosted in the first housing 3 and those included in the second housing 5, detaching the first housing 3 from the electronic control module 10 included in the second housing 5 allows to dispose them separately and through different disposing channels. In particular, the first housing 3 (and the medical items 85- 88 that it hosts) is disposed as an hospital waste, while the second housing 5 (including the electronic control module 10) is disposed as an electronic waste. According to an embodiment of the present invention, the sensor apparatus, jointly connected with the first housing 3, is realized with materials compliant with the RoHS regulations, and is disposed together with the first housing 3 (i.e., in the same disposing channel of the first housing 3) . In particular, the sensor apparatus is detachably coupled to the electrical connections 53-56 through per se known electrical coupling means (not shown) , for example by means of plug and play connections, removable connectors (such as those used in Ethernet cables) or further electrical connections detachable by tear. The sensor apparatus can thus be detached from the electrical connections 53-56 (i.e., from the electronic control module 10 and the second housing 5) , and is disposed together with the first housing 3. According to a different embodiment of the present invention, the sensor apparatus is jointly connected to the first housing 3 so that it is detachably couplable to the first housing 3. Therefore, during the use of the DD 1 the sensor apparatus is coupled to the first housing 3, while after the use (after the end of the surgical procedure) the sensor apparatus is detached and physically decoupled from the first housing 3, so that the first housing 3 (and the medical items 85-88 hosted within) is disposed separately from the sensor apparatus and the second housing 5.

The DD 1 hosts a plurality of independent detection channels (in the above described embodiment, four independent detection channels, and in further details one detection channel per compartment among the compartments 33-36) , thus allowing a contemporary detection of multiple medical items 85-88.

The electronic control module 10 works either as a standalone technology or as an MCU host slave. Moreover, the high-speed integrated cache memory enhances the performances of the DD 1, and optimizes its data storing capacity. A compact design of the electronic control module 10 reduces its dimensions, thus minimizing the required space and external components .

The audio files can be freely generated and/or recorded by the operator or by any other final user of the DD 1, therefore allowing a further customization of the use of the DD 1, and consequently of its efficiency in terms of performances .

The first and the second covers 9, 11 are detachable from the first and, respectively, the second housing 3, 5, so that the operator can visually inspect the content of the DD 1, as a final check after the DD is switched off (step S12 in Figure 5) or as a further visual check against possible counting discrepancies among the operator and the DD 1.

The communication system 74 is a wireless communication technology that avoids the presence of wires connections in the operating room. In fact, such wires connections could represent physical obstacles and cause interferences in the surgical procedure. For the same reasons, the power supply is achieved though alkaline type batteries .

The sensor apparatus exploiting IR optoelectronic devices allows reaching optimal detection performances, reducing the overall costs and maximizing the simplicity of implementation. The IR optoelectronic devices allow reducing the cost of, and the volume required by, the DD 1. Moreover, they show high reliability and low sensibility to environmental condition (such as external light or temperature and electromagnetic interferences) .

Finally, it is clear that modifications and variations may be made to what has been described and illustrated herein, without thereby departing from the scope of the present invention, as defined in the annexed claims.

The number of compartments internal to the first housing 3 can vary, and consequently the number of typologies of medical items to be detected. In particular, the number of compartments can be higher or lower than what described with reference to the exemplarily discussed embodiment of Figure 1-4.

The sensor apparatus could include other technologies than the IR optoelectronic devices previously discussed in the exemplarily described embodiment. In particular, the sensor apparatus could exploit devices such as: optoelectronic devices working in the visible range, having low costs, high stability and low variability depending on the working conditions; Hall effect sensors, having high sensitivity; devices based on ultrasound detection, or working in the radiofrequency range, or exploiting inductive or capacitive effects. Moreover, an implementation of the DD 1 including the contemporary presence of a plurality of the above-mentioned sensing techniques (as well as of other sensing techniques here not mentioned) is considered to be obvious to the person skilled in the art. In particular, one or more of such sensing techniques can be implemented in each compartment of the DD 1, according to the medical item to be detected in such compartment.

The relative distance between consecutive partition walls 80-82 could be different between each other, and thus the compartments 33-36 could define different compartment volumes .

The compartments 33-36 could host different medical items from what previously described in the exemplarily embodiment of Figures 1-4. The sensor apparatus is designed and adapted consequently to detect such different medical items, according to techniques known to the person skilled in the art .

The cover openings 27-30 can have different shapes than the rectangular one indicated in the exemplarily embodiment of Figures 1-4. In particular, the cover openings 27-30 could have different shapes between each other. The shape of each cover opening could schematically represent the medical item to be inserted in the respective compartment, as a mnemonic aid and support to the operator to further prevent incorrect insertions event by the operator .

The audio files can be generated to support also other steps of use of the DD 1, such as for the terminated- procedure message of step Sll in Figure 11.

Moreover, the first and the second cover 9, 11 could be substituted by a common cover (not shown) , that could cover, and be physically coupled to, both the first housing 3 and the second housing 5.

The plurality of counters coupled to the compartments 33-36 may be absent. The information regarding the number of medical items hosted in the compartments 33-36 is thus only stored by the external server, while the DD 1 is adapted to sense the insertion of the medical items and to transmit to the external server the new-event message, so that the external provider automatically calculates such number of medical items and updates its status consequently.

According to a further embodiment (not shown) , the sensor apparatus is hosted in the second housing and is operatively coupled to the cover openings to sense the insertion of medical items in the first housing through such cover openings. In such embodiment, the sensor apparatus exploits reflection properties. As an example, light sources (hosted by the second housing) emit respective light beams along respective light paths, extending in proximity of the respective cover openings to sense the insertion of medical items. Along each light path, a respective reflective surface (such as a mirror, reflecting the radiation at the frequency of the respective light beam) is placed, to reflect the light beam toward a light detector (i.e., so that the light beam reflected by the reflective surface is collected by the light detector) , hosted in the second housing. For example, each reflective surface is coupled to the fourth interior side wall of the first housing, at least one reflective surface per compartment. Therefore, when no medical items are inserted in the cover openings, the light beams emitted by the light sources are reflected by the respective reflective surfaces and are collected by the light detectors. When an insertion event occurs, the respective light beam emitted by the respective light source is scattered and/or absorbed by the inserted medical item, and is not collected by the respective light detector (or is only partially detected) , thus signalling an insertion event.

Furthermore, according to a different embodiment (not shown) the second housing and the second cover are absent. The first cover integrates both the electronic control module, the sensor apparatus and the electrical connections. The sensor apparatus is operatively coupled to the first cover, and in particular is placed at the cover openings to sense the insertion of medical items through the cover openings, while the electronic control module is placed in an internal compartment of the first cover. The internal compartment is realized in the first cover, so that no mass transfer occurs between the electronic control module and an exterior of the first cover (in details, the internal compartment is a closed system which is fluidically isolated from the exterior of the first cover, and the electrical connections electrically couple the electronic control module to the sensor apparatus) . According to the present embodiment, the first cover is jointly connected (i.e., physically couplable and detachable) to the first housing through the above- mentioned connection elements. Therefore, the electronic control module and the first housing are movable between the connecting position and the detached position. Since the first cover and the first housing are detachable, they are disposed separately. In particular, when in the detached position, the first housing and the partition walls physically coupled to the first housing are disposable, while the first cover is adapted to be reused. Between consecutive uses, the first cover undergoes cleaning procedures, such as cleaning, disinfection and sterilization, through per se known techniques. The isolation between the electronic control module and the exterior of the first cover allows performing the cleaning procedures without damaging the electronic control module. Moreover, in such embodiment the power supply circuits may either include the above mentioned alkaline type batteries, or power supply means exploiting magnetic induction, so that they can be easily recharged. The first cover can be adapted to first housing having different shapes and dimensions, thus being able to count also bulky medical items .