FI3797511T3

FI3797511T3 - Device and method for recognising a label deposited on an object in order to securely produce drug preparations

Info

Publication number: FI3797511T3
Application number: FIEP19726053.2T
Authority: FI
Inventors: Franc Benoît Le; Olivier Conan
Original assignee: Eurekam
Priority date: 2018-05-22
Filing date: 2019-04-15
Publication date: 2023-06-07
Also published as: EP3797511A1; PL3797511T3; HRP20230530T1; DK3797511T3; FR3081584A1; PT3797511T; ES2946592T3; FR3081584B1; EP3797511B1; WO2019224438A1

Description

1 19726053.2

DESCRIPTION

DEVICE AND METHOD FOR RECOGNISING A LABEL DEPOSITED ON AN

OBJECT IN ORDER TO SECURELY PRODUCE DRUG PREPARATIONS

Technical field

The invention relates to a method for the safe production, namely controlled and assisted, of medicinal preparations and to an imaging system capable of implementing such a method.

The field of application of the invention relates to the secured manufacture of medicinal preparations allowing release control of these preparations. This release control is necessary, since the medicinal preparations are carried out according to complex protocols, from reaction mixtures between components, each component having a concentration suitable for a custom treatment for a given patient.

Any error as to the nature of a component or its dosage may lead to serious consequences on the patient to whom the preparation is administered, in particular when a toxic active substance occurs, such as the preparations of cytotoxic agents which can be used in anticancer treatments.

In practice, the operators can work several hours consecutively, for example in hospitals preparation units, which substantially increases the risk of error on the composition or on the amounts of the components. The securing of the preparations usually results from a double visual check: verification of the key steps of each preparation and transfer written on an appropriate traceability medium, generally called a "production log”.

In order to guarantee the quality of medicinal preparations, the AFSSAPS (French

Health Safety Agency of the Health Products) has published "Good Preparation

Practices” which constitute a reference text intended for pharmacists. The "Good

Preparation Practices” specify the three obligations to which the implementation of the starting materials used in the medicinal preparations must comply with: - the method for measuring the guantities of raw materials is chosen according to their nature and the guantity to be measured;

2 19726053.2 - the volume measurement or the weighing of the guantities of raw materials is recorded; - the raw materials are permanently identifiable during the aforementioned operations.

Thus, during the preparation, the nature of each raw material used as well as its mass or its volume are checked independently either by an automatic recording means, or by a second person qualified within the meaning of the French Public

Health Code, and the verification is noted in the preparation log. To respond to the ”Good Preparation Practices” and for the safety of patients, it is therefore recommended to carry out a double control of the nature and amounts of the compositions used in each preparation.

State of the prior art

Document WO99/10027 A1 discloses a device for recognizing information data present on a surface of an object such as a vial, syringe or ampule, with a view tothe secure production of medicinal preparations. U

From the applicant's publication WO 2014/202859 A1, a method and device for taking the secure production of medicinal preparations and a support for positioning associated objects are known.

With reference to the perspective view of Figure 1, which reuses Figure 1 from the aforementioned publication, the context of monitoring the drug preparation developed by the applicant is now repeated.

A portable hood 1 incorporates a site 2 for preparing medicines. This site 2 is eguipped with an imaging system 3 (not shown) making it possible to prepare such preparations in a secure manner. This imaging system 3 comprises a so-called processing camera 4. The focal length of this camera 4 is adjusted to focus on containers and drug administration tools, here a vial 5, an infusion bag 6 containing a saline solution, and a syringe 7. In the example, vial 5 contains cisplatin to be diluted in infusion bag 6. To do this, a sample is taken by the operator into the vial 5 of cisplatin using the syringe / and then injected into the infusion bag 6. The

3 19726053.2 operation is repeated until the desired dilution of the active ingredient is obtained in the pouch to prepare, in the example, a polychemotherapy component.

Advantageously, a bottom 8 of the hood 1 has a surface structure shape adapted to the contours of the objects, promoting a stabilized, reproducible placement of the vials and syringes, and incorporates a backlight device 9 making it possible to better read the graduations of the syringe 7.

The processing camera 4 is positioned at the hood bottom 8 slightly above a work surface on which the portable hood 1 is placed, that is substantially, in the example, at stomach level of an operator (not shown).

The processing camera 4 is connected to a digital management unit, a laptop computer 11 in the example. The computer 11 mainly comprises a processor and memories (not shown) that process video signals Sv1 coming from the processing camera 4 to provide images to a display screen 12 and record them.

The display screen 12 then makes it possible to view information corresponding tothe preparation in progress from a video stream Fv1 supplied by the processing camera 4.

Another camera 13 for recording and viewing, known as a scene camera, has a focal length that is set for a general detection of the site 2. The lens of the scene camera 13 is advantageously positioned at an upper level 14 of the hood 1 so as to allow a broad view of the site 2 by transmitting a video stream Fv2 to the display screen 12.

The processing 4 and scene 13 cameras provide video signals Sv1,

Sv2 synchronized by the processor of the computer 11 in order to constitute a dynamic graphical interface for real-time and post-facto control.

The processing camera 4 is advantageously composed of two cameras 4a, 4b, of focallengths adjusted to detect objects - generally vials and syringes - in complementary dimensional ranges, less than 3 cm and comprised between 3 and 307 cm in the example.

The video streams from the processing cameras 4a and 4b are analyzed by a shape and character recognition tool, integrated into the processor of the computer 11.

4 19726053.2

The analysis allows automatic identification of the objects used, the vial 5 and syringe 7, by processing the first video streams using the recognition tool. The detection of the volumes of product contained in the syringes and the vials allows non-destructive control of the active ingredient used in the preparation.

Thus, all the data appearing on the vial 5, in particular the concentration of the active ingredient, are identified by said recognition tool. These data are stored in the computer 11. During the preparation, data for analyzing the contents of the vial and the syringe are displayed on the screen 12 and recorded in order to validate each step of the preparation: quantity of liquid in the syringe 7 and level of liquid in the vial 5.

The processor of the computer 11 searches in a memory, where a set of prescriptions is stored, for the prescription corresponding to the preparation in progress. To do this, the stored prescriptions are indexed by steps using a digital indexing tool. The key steps - which are the specific steps particular to each prescription.

The processor compares the stored data of the preparation in progress provided by the first recorded images - names of the components, amounts poured into the syringes, etc. - and the steps of the stored prescriptions. As soon as a key step of this prescription is recognized, the prescription corresponding to the preparation in progress is then identified and displayed by its steps. The information is selected according to the prescription detected from a list of available vials and a list of vials used stored in the computer as a function of data provided by the laboratory management center.

An alert display is integrated, as well as the possibility of manual interaction to remove or inject a determined volume, or to add a vial.

In addition, the state of progress of the preparation is displayed as a function of the data of the stored protocol corresponding to the identified prescription: information concerning the management of the volume contained in the vial 5 and the changes in the injected/missing/prescribed volumes of the component in the syringe 7 are displayed. This management information is initiated by incrementing the injected volumes and consequently the remaining volume, the number of injections, the number of vials and the remainders. This incrementation is automated from the

19726053.2 graphical user interface of the synchronized video streams of the cameras 4 and 13.

Such management makes it possible to substantially reduce handling errors.

The alert display is activated in real time as soon as the vial and/or the component volumes detected before injection in a step are not in accordance with the stored 5 protocol of the identified prescription. The steps detected as erroneous are identified by comparison with the steps of the prescription. The non-conformity of a key step triggers an error search in the identification of the prescription that has been selected.

The display then provides instructions and the alert is eliminated and the preparation continues only if compliance between the steps of the preparation and the ones constituting the protocol of said prescription is validated. The progress of the preparation is then updated in real time until the final validation.

The preparation is thus secured by almost instantaneous responsiveness, and the reproducibility of the preparations is optimized.

Validating the steps detected as erroneous, in particular the key preparation steps, makes it possible to continue the preparation until it is completed.

Thus, the preparation may be carried out under a fixed hood or any environment suitable for installing the imaging system.

With reference to Figures 2 to 7, which show Figures 4 to 9 of the aforementioned publication, an example of a camera system implementing the method for the secured production of medicinal preparations is described.

This system is arranged on either side of a transparent bay 15 of an enclosure for secure production of a medicinal preparation, and comprises a image capturing device 16 arranged outside the enclosure against the transparent wall 15, and a support 17 for positioning objects arranged inside the enclosure facing the image capturing device.

More precisely, as can be seen more clearly in Figure 4, the image capturing device 16 comprises two processing cameras 18, 19 arranged at the two ends of an elongated and rectangular base 20, a reflecting element 21, 22 for each of the cameras 18, 19, arranged midway through the base 20.

6 19726053.2

The two reflective elements 21, 22 are oriented along the axis defined by the two cameras, so as to reflect, in the direction of the corresponding camera, images of the object positioning support 17.

More precisely, these two reflective elements are formed by the two adjacent rectangular faces of a straight prism with a triangular base 23, the prism being mounted on the base by one of its triangular bases.

The two cameras 18, 19 have different focal lengths making it possible to focus on objects of different sizes located on the syringe and vial support. For example, the right camera can be devoted to the focus for small vials and syringes with a 12 mm lens, that of the left being able to be devoted to the focus for large vials and syringes with an 8 mm lens.

In order to provide the image capturing device with small dimensions, the two cameras will themselves have small dimensions, for example 47 x 29 x 29 mm (L x W x H). An example of cameras suitable for this use is the brand Imaging

SourceG reference DFK23F445.

The elongated base 20 is secured inside a cabinet 24 comprising a flat and substantially rectangular front face 25, the two short sides of which are slightly rounded, and provided with a substantially rectangular central visibility window 26, and an elongated rear shell 27 inside which the base 20 is rigidly secured, by its longitudinal rear edge, the prism 23 being located in the opening of the window 26 when the front face 25 of the cabinet closes the shell 27, so that the images of the syringe and vial support arrive via this prism, to the two cameras 18, 19.

The front face 25 can be secured to the shell 27 by means of screws passing through holes 28 provided for this purpose at the four corners of the front face 25 and screwed into a corresponding sleeve 29 provided for this purpose on the inner wall of the rear shell 27.

The rear shell 27 further comprises two tabs 30 extending vertically from its lower lateral edge 31, these tabs being provided with a circular central recess for receiving a magnetic means of complementary shape (metal or magnetized dot, not shown), intended to retain against the glass bay 15 and the front face 25 of

7 19726053.2 the enclosure, the syringe and vial support 17 which is provided with complementary magnetized means.

The shell 27 further comprises two rigid lateral strips 32 secured to the external face of its rear wall and projecting on either side of its ends, these two strips 32 bearing two suction cups 33 directed towards the front in order to be attached to the glazed wall of the enclosure.

Furthermore, in accordance with Figure 5, the syringe and vial support 17 comprises a flat support base 34, an inclined screen 35 raised behind the base intended to form a white back, and a syringe carrier 36 translationally mounted with respect to the base 34 between a disengaged position independent of the base 34 (shown in Figure 5) and an engaged position rigidly connected to the base 34 (shown in Figure 2).

More specifically, the syringe holder 36 comprises a rectangular plate 37, at an end of which a block 38 of substantially rectangular shape protrudes, but the upper wall of which is longitudinally recessed 39 (the upper wall is composed of inclined panels converging toward one another and joining by a common edge, defining an M-shaped cross-section) in order to serve as support for the body of a syringe, and to retain this syringe body laterally by the inclined panels.

At the other end, the plate 37 of the syringe-holder 36 comprises a stand 40 for retaining the wings 41 of a syringe 42. The stand 40 is formed by two parallel walls, separated from one another by a sufficient distance to accommodate the wings 41 of the syringe 42 (see Figure 6), and have, like the block 38, an M-shaped contour in order to support and laterally retain the syringe part near the wings 41.

In accordance with Figure 7, there is provided, for the support of small-sized syringes, an additional stand 43 between the block 38 and the main stand 40, being closer to the block 38, and taking the form of a single wall 43 with an M-shaped contour, the groove of which is found at the same level as that of the block 38.

The plate 37 of the syringe holder 36 comprises, according to Figure 5, two thinned lateral edges 44 capable of sliding in grooves formed on the lateral edges of a recess of the plate formed in the base 34, in order to be able to engage by sliding the syringe holder in the base to an engaged position (Figure 2).

8 19726053.2

In this engaged position, the syringe holder 36 and the base 34 together define a receiving relief 45 for the cup of a vial.

Indeed, the upper surfaces of the base 34 and of the plate 37 of the syringe holder 36 are coplanar when the syringe holder is in its engaged position and comprises complementary recesses 45 for receiving a vial in the shape of a half- disc, and which, when the syringe holder is in its engaged position, form a circular recess for receiving the bottom of a vial, this recess being located between the retaining stand 40 and the bearing block 38. Of course, another relief, such as a circular rib, can fulfill the same function.

The base 34 carries the complementary magnetic means 46 of those provided on the tabs 30 of the image capturing device. More precisely, these magnetic means (magnetized or metallic dot, depending on that used for the magnetic means of the image capturing device) are housed inside two lugs 47 projecting vertically from the edge of the base 34 opposite the screen 35, and having a flat front wall that can press against the inner face of the glazed bay, at the corresponding tabs 30 of the image capturing device.

The system as described above makes it possible to implement the method for the secure production of medicinal preparations, even when syringes and vials of different sizes are used, thanks to the plurality of cameras of different lenses used and to the reflective elements allowing these devices to collect images of the same zone: the syringe and vial support.

This objective is also achieved with a small form factor due to the use of a central prism for the two cameras.

However, the applicant has continued to innovate.

The applicant has noted that its system was not suitable for use with different inclinations of transparent bays relative to the work surface. Indeed, between two predetermined sites on which the drug preparation must be carried out, the inclinations of the bays may be different, forcing the applicant to adapt its system to each bay inclination.

9 19726053.2

The applicant has also noted that the positioning of the system described in the aforementioned publication could be imprecise, in particular due to the use of a suction cup. Indeed, during installation, calibration is necessary. The cleaning of the bay 15 can require the removal of the image capturing device and therefore of its suction cups. It is then difficult to reposition it identically, which may lead to image capture problems.

The applicant has also noted that the operators are subject to musculoskeletal disorders (MSDs) and that the presence of the screen involves a gesture leading to tendinitis of the rotator cuff of the shoulder of the operator when the operator uses the product.

Finally, the applicant has noted that the control of the lighting environment can be improved.

Disclosure of the invention

One aim of the invention is notably to remedy all or some of the aforementioned drawbacks.

To that end, it discloses a device for recognizing information data present on a surface of an object such as a vial, syringe or ampule, with a view to the secure production of medicinal preparations, comprising: - a so-called positioning enclosure which is arranged to receive the object and has a so-called reference surface of a predetermined color (such as white or otherwise), - a so-called capturing enclosure in which an image capturing device is arranged, the image capturing device having an optical axis which is oriented in the direction of the reference face.

The positioning enclosure and the capturing enclosure have a common wall, said common wall having a target surface which is arranged such that the optical axis of said capturing device intersects said target surface, said target surface being produced in the form of an orifice opening into the positioning enclosure and the capturing enclosure, or in a rigid and transparent material.

10 19726053.2

The device according to the invention further comprises a computation unit, configured to perform optical character recognition from an image captured by the image capturing device, said computation unit being further configured to generate output data intended for an output peripheral.

Thus, it then becomes possible to avoid musculoskeletal disorders (MSDs) since the object is easily insertable into the positioning enclosure, against the wall formed by the target surface.

The problems related to the positioning of the prior art system are solved, as well as those linked to the inclination of the glazed bays.

Finally, the output data make it possible to alert the preparer when information data that does not correspond to its expectations is recognized, or to cause it to rise when the recognized information data matches its expectations.

The information data may be carried by a label deposited on the surface of the object.

Alternatively, or additionally, information data can be carried directly on the surface of the object, for example by means of an ink printer, screen printing, or etching.

The information data can be shown in the form of digits, for example digits forming a number indicating a volume, as can be the case in the case of a syringe graduation.

The information data may be shown in the form of characters and/or digits, for example to indicate a substance and a concentration.

The information data can be encoded in two-dimensional barcode form, for example in the form of codes known as a QR code or a data matrix.

The computation unit can be inserted directly into the device or be separate.

The output peripheral may be a loudspeaker. For example, a loudspeaker of a computer screen comprising the computation unit or a separate loudspeaker. The output data are then voice information, for example recorded within a database.

The device according to the invention may further comprise a display device, configured to display an image generated by the computation unit.

11 19726053.2

The image generated by the computation unit can be produced from an image captured by the image capturing device and/or from the output data.

Advantageously, the device according to the invention may further comprise a device for illuminating a region arranged in the capturing enclosure, on the optical axis, between the capturing device and the common wall.

According to one possibility, the lighting device may be a light panel.

According to one embodiment, the device according to the invention may comprise an internal electric battery. The device is then self-contained with respect to energy and easily movable.

By way of example, the device according to the invention can be deposited on a wheeled structure, comprising for example a chassis and casters.

According to another aspect of the invention, it discloses a method for recognizing information data present on a surface of an object such as a vial, syringe or ampule, with a view to the secure production of medicinal preparations, comprising: - positioning the object in a so-called positioning enclosure, the positioning enclosure having a so-called reference face, of a predetermined color, - a capturing process in a so-called capturing enclosure, by an image capturing device, the image capturing device having an optical axis which is oriented in the direction of the reference face.

According to the second aspect of the invention, the positioning enclosure and the capturing enclosure have a common wall, said common wall having a target surface which is arranged such that the optical axis of said capturing device intersects said surface, said target surface being produced in the form of an orifice opening into the positioning enclosure and the capturing enclosure, or in a rigid and transparent material.

The method according to the second aspect of the invention further comprising: - optical character recognition by a computation unit from an image captured by the image capturing device

12 19726053.2 - generation of output data by the computation unit, to an output peripheral

Description of the figures

Other data, characteristics, and advantages of the invention will become apparent on reading the detailed description of implementations and embodiments which are in no way exhaustive, with respect to the appended drawings wherein: - Figure 1 is a perspective view of a medicinal preparation site eguipped with an example of a secure system for imaging such preparations; - Figure 2 is a perspective front view of a system for capturing images of syringes and vials of different sizes, positioning itself on the transparent bay of a preparation chamber, a syringe and vial support, internal to the enclosure, and an image capturing device external to the enclosure, - Figure 3 is a top perspective view of the system of Figure 2, - Figure 4 is an exploded view of the device of Figure 2, - Figure 5 is an exploded view of the syringe and vial support of Figure 2, showing a syringe holder in disengaged position with respect to a base of the support, - Figure 6 is a perspective view of the right side of the support supporting a syringe, - Figure 7 is a perspective view of the left side of the support without a syringe, - Figure 8 is a perspective view of the front, above and from the right of an embodiment of an image capturing device according to the invention, - Figure 9 is a perspective view of the front, below and from the left, of the image capturing device shown in Figure 8, - Figure 10 is a perspective view from the left and above the image capturing device shown in Figure 9.

Description of the embodiments

13 19726053.2

Since the embodiments described below are in no way limiting, it will in particular be possible to consider variants of the invention comprising only a selection of the features described, subsequently isolated from the other features described, if this selection of characteristics is sufficient to confer a technical advantage or to differentiate the invention from the prior art. This selection comprises at least one feature, preferably functional, without structural details, or with only a portion of the structural details if this part only is sufficient to confer a technical advantage or to differentiate the invention from the prior art.

With reference to Figure 8, a label recognition device 100 according to the invention is now described.

The device 100 has a general block shape, provided with an upper face 102, a lower face 104, two lateral faces 106 and 108, respectively left and right, a rear face 110, and a front face 112 (see Figures 9 and 10).

The image capturing device 100 is divided, by means of an opaque vertical separation wall 114, into two chambers, respectively for capturing 116 and positioning 118.

The rear face 110 and the front face 112 extend from the left lateral face 106 to the separation wall 114, leaving the compartment 118 accessible to the rear and the front.

The upper face 102 extends from the separation wall to the right lateral face 108.

A target surface 120, in the form of an orifice 120, of rectangular shape according to the shown example, is formed in the separation wall 114.

Still in the example shown, a transparent glass plate 122 of substantially identical shape to the separating wall 114 is arranged against the latter, on the side of the compartment 118.

According to another embodiment, the separation wall 114 and glass plate 122 could be joined in a single piece, for example sandblasted glass, except at the orifice portion, which would then be transparent.

14 19726053.2

The glass plate 122 constitutes, on the side of the compartment 118, a bearing surface for presenting a vial 124, provided with a label 126.

On the inside of the compartment 118, the wall 108 is provided with a reference face 128, of white color.

The compartment 116 is divided, by means of a horizontal separation plate 130 extending horizontally between the left lateral face 106 and the separation wall 114, into two housings, 132 and 134, respectively bottom and top.

A camera 136, as an image capturing device, is arranged in the housing 132 and its optical axis is directed towards the white bottom 128 and passes through the orifice 120.

More specifically, in the example shown, the orifice 120 is entirely formed in the separation wall 114, without opening into the housing 118.

Still in the example shown, the optical axis of the camera 136 is perpendicular to the plane of the orifice 120 and centered in the middle of the orifice 120.

In the embodiment shown, the camera 136 is attached to a camera support 138, itself mounted to slide along an axis parallel to the optical axis, on two slides, 140 and 142, respectively front and rear.

In a variant of this first embodiment of a device according to the invention, only described for its difference with this first embodiment, the camera could be secured to the image capturing device 100, for example directly attached to the lower face 104.

As can more clearly be seen in Figures 2 and 3, an LED-type illumination plate 144, as a lighting device, is mounted on the separation plate 130, on the side of the housing 132.

Also, the image capturing environment, both on the side of the compartment 118 and of the housing 132, is controlled, both from the point of view of the light and the back, but also from the distance of the object to the camera.

15 19726053.2

The upper face 102 also makes it possible to better control the environment, for example preventing neon light rays from disturbing the environment of the image capturing device.

The housing 134 is arranged to receive, in a retractable manner, a computer- screen 146.

The screen computer is also equipped with loudspeakers.

When an object 124 having a label 126 is placed in front of the orifice 120, the object is detected by the camera 136.

The camera 136 then carries out several image captures, which are sent to the microprocessor of the computer-screen 146.

The microprocessor is configured to perform an OCR-type recognition of the characters inscribed on the label 126.

When this recognition is successful, the microprocessor is configured to play a sound, via the loudspeakers, associated with the label 126.

The microprocessor may further be configured to display the image captures on the screen.

The microprocessor can also be configured to time-stamp, if appropriate, the recognized image and, for example, to write the time, the day, the name of the institution, and a room number, thus ensuring traceability.

The screen computer may also be equipped with a webcam.

The screen computer may also be provided with a wired or non-wired network connection.

The screen computer may also be equipped with a USB port.

Also, the operator can have an oral, and/or visual confirmation by means of the screen, of the content of the object, by reading the label.

The object could be an ampule, or a syringe, or a mere label.

16 19726053.2

Of course, the loudspeaker, the screen and even the computer could be remote.

In this case, the housing 134 could be provided with a preparation surface for placing a preparation plate.

The image capturing device 100 can be supplied with energy, or be self- contained in energy.

The image capturing device 100 may be provided with a wheeled structure, for example casters.

Of course, the invention is not limited to the examples that have just been described and numerous modifications can be made to these examples without departing from the scope of the invention. In addition, the different features, forms, variants and embodiments of the invention may be associated with one another in various combinations insofar as they are not incompatible or exclusive of one another.

Claims

1 19726053.

2 DESCRIPTION DEVICE AND METHOD FOR RECOGNISING A LABEL DEPOSITED ON AN OBJECT IN ORDER TO SECURELY PRODUCE DRUG PREPARATIONS Technical field The invention relates to a method for the safe production, namely controlled and assisted, of medicinal preparations and to an imaging system capable of implementing such a method.

The field of application of the invention relates to the secured manufacture of medicinal preparations allowing release control of these preparations.

This release control is necessary, since the medicinal preparations are carried out according to complex protocols, from reaction mixtures between components, each component having a concentration suitable for a custom treatment for a given patient.

In practice, the operators can work several hours consecutively, for example in hospitals preparation units, which substantially increases the risk of error on the composition or on the amounts of the components.

The securing of the preparations usually results from a double visual check: verification of the key steps of each preparation and transfer written on an appropriate traceability medium, generally called a "production log”. In order to guarantee the quality of medicinal preparations, the AFSSAPS (French Health Safety Agency of the Health Products) has published "Good Preparation

Practices” which constitute a reference text intended for pharmacists.

The "Good Preparation Practices” specify the three obligations to which the implementation of the starting materials used in the medicinal preparations must comply with: - the method for measuring the guantities of raw materials is chosen according to their nature and the guantity to be measured;

Thus, during the preparation, the nature of each raw material used as well as its mass or its volume are checked independently either by an automatic recording means, or by a second person qualified within the meaning of the French Public Health Code, and the verification is noted in the preparation log.

To respond to the ”Good Preparation Practices” and for the safety of patients, it is therefore recommended to carry out a double control of the nature and amounts of the compositions used in each preparation.

State of the prior art Document WO99/10027 A1 discloses a device for recognizing information data present on a surface of an object such as a vial, syringe or ampule, with a view tothe secure production of medicinal preparations.

U From the applicant's publication WO 2014/202859 A1, a method and device for taking the secure production of medicinal preparations and a support for positioning associated objects are known.

A portable hood 1 incorporates a site 2 for preparing medicines.

This site 2 is eguipped with an imaging system 3 (not shown) making it possible to prepare such preparations in a secure manner.

This imaging system 3 comprises a so-called processing camera 4. The focal length of this camera 4 is adjusted to focus on containers and drug administration tools, here a vial 5, an infusion bag 6 containing a saline solution, and a syringe 7. In the example, vial 5 contains cisplatin to be diluted in infusion bag 6. To do this, a sample is taken by the operator into the vial 5 of cisplatin using the syringe / and then injected into the infusion bag 6. The

Advantageously, a bottom 8 of the hood 1 has a surface structure shape adapted to the contours of the objects, promoting a stabilized, reproducible placement of the vials and syringes, and incorporates a backlight device 9 making it possible to better read the graduations of the syringe 7. The processing camera 4 is positioned at the hood bottom 8 slightly above a work surface on which the portable hood 1 is placed, that is substantially, in the example, at stomach level of an operator (not shown).

The processing camera 4 is connected to a digital management unit, a laptop computer 11 in the example.

The computer 11 mainly comprises a processor and memories (not shown) that process video signals Sv1 coming from the processing camera 4 to provide images to a display screen 12 and record them.

The processing 4 and scene 13 cameras provide video signals Sv1,

4 19726053.2 The analysis allows automatic identification of the objects used, the vial 5 and syringe 7, by processing the first video streams using the recognition tool.

The detection of the volumes of product contained in the syringes and the vials allows non-destructive control of the active ingredient used in the preparation.

Thus, all the data appearing on the vial 5, in particular the concentration of the active ingredient, are identified by said recognition tool.

These data are stored in the computer 11. During the preparation, data for analyzing the contents of the vial and the syringe are displayed on the screen 12 and recorded in order to validate each step of the preparation: quantity of liquid in the syringe 7 and level of liquid in the vial 5.

The processor of the computer 11 searches in a memory, where a set of prescriptions is stored, for the prescription corresponding to the preparation in progress.

To do this, the stored prescriptions are indexed by steps using a digital indexing tool.

The key steps - which are the specific steps particular to each prescription.

The processor compares the stored data of the preparation in progress provided by the first recorded images - names of the components, amounts poured into the syringes, etc. - and the steps of the stored prescriptions.

As soon as a key step of this prescription is recognized, the prescription corresponding to the preparation in progress is then identified and displayed by its steps.

The information is selected according to the prescription detected from a list of available vials and a list of vials used stored in the computer as a function of data provided by the laboratory management center.

In addition, the state of progress of the preparation is displayed as a function of the data of the stored protocol corresponding to the identified prescription: information concerning the management of the volume contained in the vial 5 and the changes in the injected/missing/prescribed volumes of the component in the syringe 7 are displayed.

This management information is initiated by incrementing the injected volumes and consequently the remaining volume, the number of injections, the number of vials and the remainders.

This incrementation is automated from the

19726053.2 graphical user interface of the synchronized video streams of the cameras 4 and 13. Such management makes it possible to substantially reduce handling errors.

The alert display is activated in real time as soon as the vial and/or the component volumes detected before injection in a step are not in accordance with the stored 5 protocol of the identified prescription.

The steps detected as erroneous are identified by comparison with the steps of the prescription.

The non-conformity of a key step triggers an error search in the identification of the prescription that has been selected.

The display then provides instructions and the alert is eliminated and the preparation continues only if compliance between the steps of the preparation and the ones constituting the protocol of said prescription is validated.

The progress of the preparation is then updated in real time until the final validation.

6 19726053.2 The two reflective elements 21, 22 are oriented along the axis defined by the two cameras, so as to reflect, in the direction of the corresponding camera, images of the object positioning support 17. More precisely, these two reflective elements are formed by the two adjacent rectangular faces of a straight prism with a triangular base 23, the prism being mounted on the base by one of its triangular bases.

The two cameras 18, 19 have different focal lengths making it possible to focus on objects of different sizes located on the syringe and vial support.

For example, the right camera can be devoted to the focus for small vials and syringes with a 12 mm lens, that of the left being able to be devoted to the focus for large vials and syringes with an 8 mm lens.

In order to provide the image capturing device with small dimensions, the two cameras will themselves have small dimensions, for example 47 x 29 x 29 mm (L x W x H). An example of cameras suitable for this use is the brand Imaging SourceG reference DFK23F445. The elongated base 20 is secured inside a cabinet 24 comprising a flat and substantially rectangular front face 25, the two short sides of which are slightly rounded, and provided with a substantially rectangular central visibility window 26, and an elongated rear shell 27 inside which the base 20 is rigidly secured, by its longitudinal rear edge, the prism 23 being located in the opening of the window 26 when the front face 25 of the cabinet closes the shell 27, so that the images of the syringe and vial support arrive via this prism, to the two cameras 18, 19. The front face 25 can be secured to the shell 27 by means of screws passing through holes 28 provided for this purpose at the four corners of the front face 25 and screwed into a corresponding sleeve 29 provided for this purpose on the inner wall of the rear shell 27. The rear shell 27 further comprises two tabs 30 extending vertically from its lower lateral edge 31, these tabs being provided with a circular central recess for receiving a magnetic means of complementary shape (metal or magnetized dot, not shown), intended to retain against the glass bay 15 and the front face 25 of

Furthermore, in accordance with Figure 5, the syringe and vial support 17 comprises a flat support base 34, an inclined screen 35 raised behind the base intended to form a white back, and a syringe carrier 36 translationally mounted with respect to the base 34 between a disengaged position independent of the base 34 (shown in Figure 5) and an engaged position rigidly connected to the base 34 (shown in Figure 2). More specifically, the syringe holder 36 comprises a rectangular plate 37, at an end of which a block 38 of substantially rectangular shape protrudes, but the upper wall of which is longitudinally recessed 39 (the upper wall is composed of inclined panels converging toward one another and joining by a common edge, defining an M-shaped cross-section) in order to serve as support for the body of a syringe, and to retain this syringe body laterally by the inclined panels.

At the other end, the plate 37 of the syringe-holder 36 comprises a stand 40 for retaining the wings 41 of a syringe 42. The stand 40 is formed by two parallel walls, separated from one another by a sufficient distance to accommodate the wings 41 of the syringe 42 (see Figure 6), and have, like the block 38, an M-shaped contour in order to support and laterally retain the syringe part near the wings 41. In accordance with Figure 7, there is provided, for the support of small-sized syringes, an additional stand 43 between the block 38 and the main stand 40, being closer to the block 38, and taking the form of a single wall 43 with an M-shaped contour, the groove of which is found at the same level as that of the block 38. The plate 37 of the syringe holder 36 comprises, according to Figure 5, two thinned lateral edges 44 capable of sliding in grooves formed on the lateral edges of a recess of the plate formed in the base 34, in order to be able to engage by sliding the syringe holder in the base to an engaged position (Figure 2).

8 19726053.2

The base 34 carries the complementary magnetic means 46 of those provided on the tabs 30 of the image capturing device.

More precisely, these magnetic means (magnetized or metallic dot, depending on that used for the magnetic means of the image capturing device) are housed inside two lugs 47 projecting vertically from the edge of the base 34 opposite the screen 35, and having a flat front wall that can press against the inner face of the glazed bay, at the corresponding tabs 30 of the image capturing device.

However, the applicant has continued to innovate.

The applicant has noted that its system was not suitable for use with different inclinations of transparent bays relative to the work surface.

Indeed, between two predetermined sites on which the drug preparation must be carried out, the inclinations of the bays may be different, forcing the applicant to adapt its system to each bay inclination.

9 19726053.2 The applicant has also noted that the positioning of the system described in the aforementioned publication could be imprecise, in particular due to the use of a suction cup.

Indeed, during installation, calibration is necessary.

The cleaning of the bay 15 can require the removal of the image capturing device and therefore of its suction cups.

It is then difficult to reposition it identically, which may lead to image capture problems.

Disclosure of the invention

To that end, it discloses a device for recognizing information data present on a surface of an object such as a vial, syringe or ampule, with a view to the secure production of medicinal preparations, comprising:

- a so-called positioning enclosure which is arranged to receive the object and has a so-called reference surface of a predetermined color (such as white or otherwise),

- a so-called capturing enclosure in which an image capturing device is arranged, the image capturing device having an optical axis which is oriented in the direction of the reference face.

10 19726053.2 The device according to the invention further comprises a computation unit, configured to perform optical character recognition from an image captured by the image capturing device, said computation unit being further configured to generate output data intended for an output peripheral.

The computation unit can be inserted directly into the device or be separate.

The output peripheral may be a loudspeaker.

For example, a loudspeaker of a computer screen comprising the computation unit or a separate loudspeaker.

The output data are then voice information, for example recorded within a database.

11 19726053.2

According to one possibility, the lighting device may be a light panel.

According to one embodiment, the device according to the invention may comprise an internal electric battery.

The device is then self-contained with respect to energy and easily movable.

According to another aspect of the invention, it discloses a method for recognizing information data present on a surface of an object such as a vial, syringe or ampule, with a view to the secure production of medicinal preparations, comprising:

- positioning the object in a so-called positioning enclosure, the positioning enclosure having a so-called reference face, of a predetermined color,

- a capturing process in a so-called capturing enclosure, by an image capturing device, the image capturing device having an optical axis which is oriented in the direction of the reference face.

12 19726053.2

- generation of output data by the computation unit, to an output peripheral Description of the figures Other data, characteristics, and advantages of the invention will become apparent on reading the detailed description of implementations and embodiments which are in no way exhaustive, with respect to the appended drawings wherein: - Figure 1 is a perspective view of a medicinal preparation site eguipped with an example of a secure system for imaging such preparations; - Figure 2 is a perspective front view of a system for capturing images of syringes and vials of different sizes, positioning itself on the transparent bay of a preparation chamber, a syringe and vial support, internal to the enclosure, and an image capturing device external to the enclosure,

- Figure 3 is a top perspective view of the system of Figure 2,

- Figure 4 is an exploded view of the device of Figure 2,

- Figure 5 is an exploded view of the syringe and vial support of Figure 2,

showing a syringe holder in disengaged position with respect to a base of the support, - Figure 6 is a perspective view of the right side of the support supporting a syringe,

- Figure 7 is a perspective view of the left side of the support without a syringe, - Figure 8 is a perspective view of the front, above and from the right of an embodiment of an image capturing device according to the invention, - Figure 9 is a perspective view of the front, below and from the left, of the image capturing device shown in Figure 8, - Figure 10 is a perspective view from the left and above the image capturing device shown in Figure 9.

Description of the embodiments

13 19726053.2 Since the embodiments described below are in no way limiting, it will in particular be possible to consider variants of the invention comprising only a selection of the features described, subsequently isolated from the other features described, if this selection of characteristics is sufficient to confer a technical advantage or to differentiate the invention from the prior art.

This selection comprises at least one feature, preferably functional, without structural details, or with only a portion of the structural details if this part only is sufficient to confer a technical advantage or to differentiate the invention from the prior art.

The device 100 has a general block shape, provided with an upper face 102, a lower face 104, two lateral faces 106 and 108, respectively left and right, a rear face 110, and a front face 112 (see Figures 9 and 10). The image capturing device 100 is divided, by means of an opaque vertical separation wall 114, into two chambers, respectively for capturing 116 and positioning 118. The rear face 110 and the front face 112 extend from the left lateral face 106 to the separation wall 114, leaving the compartment 118 accessible to the rear and the front.

The upper face 102 extends from the separation wall to the right lateral face 108. A target surface 120, in the form of an orifice 120, of rectangular shape according to the shown example, is formed in the separation wall 114. Still in the example shown, a transparent glass plate 122 of substantially identical shape to the separating wall 114 is arranged against the latter, on the side of the compartment 118. According to another embodiment, the separation wall 114 and glass plate 122 could be joined in a single piece, for example sandblasted glass, except at the orifice portion, which would then be transparent.

14 19726053.2 The glass plate 122 constitutes, on the side of the compartment 118, a bearing surface for presenting a vial 124, provided with a label 126. On the inside of the compartment 118, the wall 108 is provided with a reference face 128, of white color.

A camera 136, as an image capturing device, is arranged in the housing 132 and its optical axis is directed towards the white bottom 128 and passes through the orifice 120. More specifically, in the example shown, the orifice 120 is entirely formed in the separation wall 114, without opening into the housing 118. Still in the example shown, the optical axis of the camera 136 is perpendicular to the plane of the orifice 120 and centered in the middle of the orifice 120. In the embodiment shown, the camera 136 is attached to a camera support 138, itself mounted to slide along an axis parallel to the optical axis, on two slides, 140 and 142, respectively front and rear.

In a variant of this first embodiment of a device according to the invention, only described for its difference with this first embodiment, the camera could be secured to the image capturing device 100, for example directly attached to the lower face 104. As can more clearly be seen in Figures 2 and 3, an LED-type illumination plate 144, as a lighting device, is mounted on the separation plate 130, on the side of the housing 132. Also, the image capturing environment, both on the side of the compartment 118 and of the housing 132, is controlled, both from the point of view of the light and the back, but also from the distance of the object to the camera.

15 19726053.2 The upper face 102 also makes it possible to better control the environment, for example preventing neon light rays from disturbing the environment of the image capturing device.

The screen computer is also equipped with loudspeakers.

When an object 124 having a label 126 is placed in front of the orifice 120, the object is detected by the camera 136. The camera 136 then carries out several image captures, which are sent to the microprocessor of the computer-screen 146. The microprocessor is configured to perform an OCR-type recognition of the characters inscribed on the label 126. When this recognition is successful, the microprocessor is configured to play a sound, via the loudspeakers, associated with the label 126.

The screen computer may also be equipped with a webcam.

The screen computer may also be equipped with a USB port.

The object could be an ampule, or a syringe, or a mere label.

16 19726053.2 Of course, the loudspeaker, the screen and even the computer could be remote.

Of course, the invention is not limited to the examples that have just been described and numerous modifications can be made to these examples without departing from the scope of the invention.

In addition, the different features, forms, variants and embodiments of the invention may be associated with one another in various combinations insofar as they are not incompatible or exclusive of one another.