EP3728048B1 - Machine and method for packaging by at least one sterilisation packaging material - Google Patents

Description

The present invention relates to the packaging of sterilization baskets and more particularly to a machine for the automated or semi-automated packaging of a sterilization basket and an associated packaging method.

Medical devices and in particular instruments intended to be in contact with the human body and/or used in operating theatres, such as surgical instruments, are generally packaged in sterilization baskets (also called trays) which are then packed with sterile barrier systems.

These can be of several types: pouches, pouches, sachets, sheaths, envelopes, containers or sterilization sheets.

The choice of packaging depends on the size of the devices, their weight and the risks associated with handling and transporting them.

Packaging in the form of sachets or envelopes is limited in capacity and cannot accommodate bulky and/or heavy objects.

Given their low cost and adaptability to the different baskets available, sterilization sheets are commonly used in sterilization centers. Sterilization sheets are in particular particularly suitable for packaging bulky and/or heavy objects such as sterilization baskets.

A first technique commonly used in the medical environment for packaging sterilization baskets with sterilization sheets is the so-called “Pasteur folding” technique. According to this technique, a sterilization sheet is repeatedly folded so as to obtain sufficient tortuosity to maintain the sterility of the contents of the package, without any sealing being carried out.

However, if the folding is of poor quality, the sterility of the object will not be maintained over time. Indeed, the quality of the folding depends on the maintenance of sterility.

It is known to wrap the sterilization baskets in a double wrap, consisting of two sterilization sheets, in order to improve the preservation of the sterile state. The folding operation is then carried out sequentially, in two steps, first using a first sterilization sheet also called primary or inner packaging, then a second sterilization sheet also called secondary packaging. or outside. The primary packaging, which has an individual protective role in sterility, constitutes an impermeable barrier to micro-organisms around the sterilization basket. The secondary packaging, which surrounds the primary packaging, is designed to ensure the protection of the primary packaging and its contents until its point of use. Secondary packaging prevents any damage that may occur to the primary packaging and its contents, in particular during handling, transport or storage operations.

This double packaging system combining microbiological protection by the primary packaging and mechanical protection by the secondary packaging, makes it possible to improve the maintenance of sterility. However, it requires a sequential folding operation, which has the disadvantage of lengthening the time of the folding operation carried out by the operator.

Requests EP 0 707 460 A1 and EP 1 362 557 A1 teach the possibility of wrapping the sterilization baskets in a double packaging, the folding operation being carried out in a single step, which offers a saving in terms of time and simplicity of implementation of the folding operation. The sterilization wrap then consists of two sterilization sheets attached to each other at the edges so as to be held together. The edges of the sterilization sheets can be joined together, in particular by adhesives, stitching, thermal or ultrasonic bonding. For example, the sterilization wrap is made of two polypropylene sterilization sheets with an SMS (Spunbond-Meltblown-Spunbond) structure that are heat sealed together at the edges.

The methods of packaging baskets with sterilization sheets remain manual to this day. The quality of folding, and therefore the maintenance of sterility, therefore has the disadvantage of depending very significantly on human intervention. Furthermore, the bending operation requires operator training. This folding operation is therefore costly in terms of time and labor, in addition to being repetitive and tedious.

A second technique consists in putting the object to be sterilized in a peelable packaging. Once the object is in the packaging, the packaging is sealed and then subjected to the sterilization step. The packaging is most often made up of two separate sheets made of different materials. One of the sheets is usually transparent. The packaging is adapted to the sterilization technique used. This technique has the advantage of not requiring a folding operation, which saves time. However, since peelable packaging consists of two heat-sealed sheets, the mechanical strength can be limited by the mechanical strength of the weld which provides the junction between the two sheets, or by the strength of the packaging itself. This technique is therefore not the first choice for packaging bulky and/or heavy sterilization baskets.

Requirement EP 1 281 617 A1 discloses a device for wrapping a product, such as one or more slices of cheese or meat, in film material to form a wrap having a predefined maximum wrap height, the device comprising a base frame.

The invention aims to further improve the devices and methods used to condition sterilization baskets, and in particular to remedy all or part of the above drawbacks. It achieves this by means of a machine for the packaging by at least one sterilization packaging material, in particular a sterilization sheet, of an object, in particular a sterilization basket, according to claim 1.

The machine according to the invention allows the packaging by at least one sterilization packaging material of an object which can contain medical devices, in particular reusable, freshly washed and disinfected. These medical devices may be items intended to be in contact with the human body and/or used in operating theatres, such as surgical gowns and/or surgical instruments, in particular scalpels, forceps, scissors, endoscopes, basins, trays or tongue depressors.

The machine according to the invention can be used in sterilization centers, in particular hospitals and healthcare establishments, and/or by manufacturers of surgical packs.

The machine according to the invention can be used to wrap an object, such as a sterilization basket, whether it is a standardized basket such as a basket meeting the ISO 3394 standard or the DIN 58952 standard, or a basket not standardized.

The machine according to the invention allows automation of the folding operation, which generates on the one hand a reduction in the cost of production of a basket of sterilization, in particular by transferring part of the available workforce to other tasks.

On the other hand the risk of human error is reduced.

The risks of developing musculoskeletal disorders are also reduced.

Another advantage is that, in terms of productivity, the automated folding operation carried out by the machine according to the invention is at least as fast as a manual folding operation carried out by a human operator.

The term "sterilization packaging material" denotes any packaging material intended for sterilization, that is to say any packaging material which is compatible with a sterilization process, in particular by EtO gas and/or by steam and/or by dry heat and/or by low-temperature formaldehyde steam (LTFS process) and/or any other oxidative or non-oxidative sterilization process, while providing the bacterial barrier required to allow sterility to be maintained for the duration of life claimed for the packed object. The sterilization packaging material is for example a sterilization sheet and must then meet the general requirements described in the international standard ISO 11607-1: 2006/A1: 2014: "Packaging of medical devices sterilized at the terminal stage - Part 1: Requirements for materials, sterile barrier systems and packaging systems" defining, in particular, the microbial barrier properties and the compatibility with the sterilization process. The performance of sterilization sheets is also described in the European standard EN 868-2: 2017: "Packaging materials and systems for terminally sterilized medical devices - Part 2: Sterilization wrap - Requirements and test methods" . The sterilization packaging material can also be a sterile field according to ISO 13795 and/or AAMI PB 70 standards. The sterilization packaging material can also be a sterile presentation field (also called "inner wrap") allowing the aseptic transfer of medical devices. The sterilization wrap material may or may not be shape memory sterilization wrap material. In the case where the sterilization packaging material is a shape memory sterilization packaging material, the latter may be based on cellulose.

The plate and the gripping tool are designed to rotate relative to each other. This makes it possible to use only one gripping tool to carry out all the bending steps, therefore to have a simpler construction machine.

The plate is rotatable around a vertical axis of rotation. This makes it possible to have a gripping tool whose movement is simpler, for example is carried out in translation along several axes relative to a frame, without rotational movement. This approach makes it possible to simplify the machine by reducing the number of axes of movement necessary for the movement of the tools of the machine. This makes it possible to minimize the cost of the machine.

The gripping tool can thus be movable vertically and along at least one horizontal axis.

The gripping tool preferably comprises a pressing system comprising a movable pad vertically facing a support surface. This makes it possible to hold the sterilization packaging material effectively, by pinching between the pad and the support surface.

The gripping tool preferably has a surface on which opens at least one orifice selectively connected to a vacuum source. This vacuum source can be a depression created by the Venturi effect. In the case where the packaging of the object is made with several sterilization packaging, for example a double packaging made with two sterilization sheets in a sequential manner, this allows the separation of the sterilization sheets by a suction cup effect. This vacuum source allows optimization of the gripping of the sterilization packaging material as well as its unitary selection.

In an exemplary embodiment, the orifice opens onto the underside of the pad of the gripping tool.

Preferably, the gripping tool comprises a member for pushing the sterilization packaging material under the object. This makes it possible to form a retaining flap of a previously formed pleat.
This member may be in the form of a horizontal plate mounted at the lower end of the gripping tool, this plate preferably becoming thinner in the direction of its distal edge. Thus, the plate may have a thin free edge, which facilitates its insertion between the object and the portion of the sterilization packaging material on which it is placed. Preferably, the plate comprises at least one vertically movable finger, to lift the object and the sterilization packaging material locally. This finger can be actuated when the aforementioned plate is used to push the sterilization packaging material under the object.

Preferably, the machine comprises a table extending around the plate. Preferably, the sterilization wrap material is larger than the tray, such that its four corners extend beyond the tray. The table accommodates these wedges of sterilization wrap material.

Preferably, the table has at least one truncated corner. Thus, the corner of the sterilization wrap material that is in this truncated corner does not rest on the table, but extends cantilevered beyond this truncated corner, which facilitates the accessibility of the tray to the operators, when the placement and removal of the object are not automated, or to any conveying system and/or suitable automaton.

The machine may comprise at least one holding and/or bending tool, the holding and/or bending tool and the plate being able to move relative to each other, the holding tool and/or folding being arranged to act on the sterilization packaging material when at least one fold has been formed along one side of the object, by coming flattened with the aid of at least one flattening member the sterilization wrap material on at least one adjacent side of the object, adjacent to the side along which the fold was formed and around which the next fold is to be made. Such a holding and/or folding tool facilitates the making of the other three folds after the first, by ensuring that the previously formed fold is brought inwards and pressed against the object when the next one is formed.

Preferably, the holding and/or folding tool comprises a pushing member, movable inwards to push inwards a portion of the sterilization packaging material extending along the fold already formed, next to the portion of the sterilization packaging material already pressed against the object.

The pressing member may be in the form of a vertical fixed plate, and the thrust member in the form of a vertical plate, movable around a horizontal axis of rotation, preferably between a raised position and a lowered position where it overlaps at least partially with the fixed plate. The holding and/or folding tool, in particular with its pressing member and/or its pushing member, makes it possible to solve the problems of use of packaging materials of shape memory sterilization, such as cellulose-based sterilization packaging materials, including crepe papers, reinforced papers and/or cellulosic nonwovens.

Preferably, the machine comprises at least two clamps making it possible to grasp at least a portion of the packaging between them and to lift it, so as to allow a corner of the sterilization packaging material to be pushed under the portion or portions thus lifted . This or these packaging portions can be formed from one or more thicknesses of the sterilization packaging material, which happen to cover the object due to the preceding folding operations.

The two clamps can be mounted so as to be able to move away from each other and stretch the gripped portion or portions. This facilitates engagement of a portion of the sterilization wrap material under the stretched and lifted portion(s). Preferably, the clamps are pivotally mounted on the holding and/or bending tool.

Preferably, the machine comprises a system for holding the object comprising at least two movable lateral holding members, between which the object can be held laterally. This holding system can in particular be useful when the last flap has to be formed.

The side holding members can be formed by two pivoting flaps, mounted on the bending and/or holding tool.

Thus, the latter can carry several members implemented at different stages, which makes it possible to pool the drive mechanism relative to the frame for all these members, thus simplifying the machine and optimizing its cost.

In an exemplary implementation of the invention, the holding and/or bending tool comprises two lateral parts each comprising a U-shaped frame, with a front profile carrying one of the thrust members and a rear profile carrying one of the clamps.

Each side part may comprise an intermediate profile, each of the flaps being hinged between this intermediate profile and the rear profile.

The machine may include a system for verifying the positioning of the object relative to the sterilization packaging material and/or a system for verifying the positioning of the sterilization packaging material relative to the tray. This or these verification systems are for example optical, and rely on image processing by one or more cameras.

The machine may include a system for verifying the conformity of the composition of the contents of the object before and/or after packaging. This verification system is for example optical, being done in particular by laser analysis, or by weighing the object, or any other verification system.

The machine may include a system for labeling and/or marking the object before and/or after packaging, in particular allowing its traceability. This labeling and/or marking system is for example of the laser or inkjet printing type.

The machine may comprise a system for recording, storing, and managing data allowing the traceability of the operations carried out by the latter.

The machine may include a connection with a computerized data management system.

Preferably, the machine comprises a system for validating the closure of the sterilization packaging enveloping the object, and in particular a system for validating the closure of a surgical pack. This makes it possible to obtain repeatable and reproducible closures according to international validation standards ISO 11607-2: 2016.

The machine may comprise a packaging closing system with at least one adhesive tape containing or not containing at least one sterilization indicator. The closing system meets the requirements of the ISO 11607-1 standard which notably defines a closing system with a tamper-evident device. The closure system is operative up to the point of use.

The machine may comprise at least one dispenser for unwinding a reel of adhesive tape, whether or not containing at least one sterilization indicator, and a device for cutting this tape to close the packaging.

The machine may include at least one reel for unwinding a reel of sterilization packaging material and a device for cutting this sterilization packaging material. The machine may, in particular in this case, include a system for automatically measuring the size of the object and adapting the size of the sterilization packaging material accordingly.

Alternatively, the sterilization packaging materials are pre-cut, and are present for example in a stack next to the machine.

The machine may include a system for placing the sterilization packaging material on the tray and/or a system for placing the object on the sterilization packaging material.

The machine may include a system for recovering the object once wrapped.

Another subject of the invention is an assembly comprising a machine according to claim 1, at least one object to be wrapped, preferably a sterilization basket, and at least one sterilization packaging material, preferably a sterilization sheet for wrapping the object.

A further subject of the invention is a packaging method according to claim 13.

During this process, at least four folds are formed by successively grasping a corner of the sterilization packaging material using the gripping tool and by moving the sterilization packaging material by this corner above above the object.

Advantageously, between two folds, the sterilization packaging material is rotated with the object on it relative to the gripping tool, preferably by rotating the platen, in particular through 90°.

After the formation of the first fold, one can push the first corner having been seized to make this first fold, under the object.

Preferably, for the formation of the following folds, the sterilization packaging material is held against the object and a previously formed fold is pushed laterally inwards.

Also preferably, after the formation of the last fold, at least a portion of the sterilization packaging material located on the top of the object, formed during a previous fold, is seized and the last fold is folded under this or these portions. To form this flap, said portion or portions are preferably stretched between two clamps, and they are lifted slightly.

The sterilization packaging material can be pushed under this or these portions using the same member as that used to form the first flap in pushing the first wedge under the object. During this operation, the holding and/or bending tool can be used to both grasp said portion(s) with the pliers, and block the object laterally between the aforementioned lateral holding members.

Preferably, the machine is thus used to perform a Pasteur-type folding. This type of folding makes it possible to reduce the size of the machine and the area of the sterilization packaging materials used. Thus, the size of the machine is reduced and the surface of the sterilization packaging materials used is optimized, which in particular makes it possible to reduce the quantity of waste produced. In addition, Pasteur-type folding is recognized by the various standards for sterilization.

The packaging can be made with one or, better, two sterilization packaging materials.

In this case, the packaging is carried out for example sequentially, by packaging the object a first time with a first sterilization packaging material, then by packaging the object thus packaged a second time using a second sterilization wrap material.

It is also possible to proceed all at once using sterilization packaging materials joined together at one or more bonding sites.

The wrap may be made with two sterilization wrap materials, wherein the two sterilization wrap materials may be joined together at one or more bonding sites and the wrap may be made simultaneously with both sterilization packaging materials.

• Les figures 1A à 1D représentent de façon schématique et en perspective un exemple de machine selon l'invention,
• les figures 2 et 3 représentent isolément l'outil de préhension de la machine de la figure 1,
• la figure 4 représente un détail de l'outil de préhension,
• la figure 4A est une section transversale dans le plan A de la figure 4,
• les figures 5 à 9 représentent isolément l'outil de maintien et/ou de pliage, dans différentes configurations,
• les figures 10A à 10U illustrent différentes étapes du fonctionnement de la machine pour emballer un panier de stérilisation,
• la figure 11 représente isolément la feuille de stérilisation F en vue de dessus,
• la figure 12 est une vue analogue à la figure 11 avec le panier de stérilisation B posé sur la feuille,
• la figure 13 représente isolément le panier de stérilisation B en perspective,
• les figures 14 et 15 sont des sections transversales schématiques et partielles, selon XII-XII de la figure 12, après formation de premier et deuxième rabats respectivement,
• la figure 16 illustre un système d'alimentation de la machine en feuilles de stérilisation, et
• la figure 17 illustre isolément le panier de stérilisation B après formation du quatrième pli et avant formation du deuxième rabat.

The invention can be better understood on reading the detailed description which follows, of a non-limiting example of implementation thereof, and on examining the appended drawing, in which:

• The figures 1A to 1D represent schematically and in perspective an example of a machine according to the invention,
• the figures 2 and 3 represent in isolation the gripping tool of the machine of the figure 1 ,
• the figure 4 represents a detail of the gripping tool,
• the figure 4A is a cross section in plane A of the figure 4 ,
• the figures 5 to 9 represent the holding and/or bending tool in isolation, in different configurations,
• the figures 10A to 10U illustrate different stages in the operation of the machine to wrap a sterilization basket,
• the figure 11 represents in isolation the sterilization sheet F in top view,
• the figure 12 is a view analogous to figure 11 with the sterilization basket B placed on the sheet,
• the figure 13 represents in isolation the sterilization basket B in perspective,
• the figures 14 and 15 are schematic and partial cross-sections, according to XII-XII of the figure 12 , after formation of first and second flaps respectively,
• the figure 16 illustrates a system for supplying the machine with sterilization sheets, and
• the figure 17 illustrates in isolation the sterilization basket B after formation of the fourth fold and before formation of the second flap.

The machine 1 according to the invention, shown in figure 1 in particular, comprises a chassis 2 as well as a control panel 3 and one or more electrical and/or pneumatic and/or hydraulic cabinets 4.

The machine 1 can be integrated within a production line and connected to conveyors and/or automatons making it possible to bring the sterilization sheets and the baskets to be packaged as well as, where appropriate, to recover the packaged baskets. These ancillary elements have not been shown in the drawing, for the sake of clarity.

The term “basket” designates here any receptacle capable of receiving objects to be sterilized.

The machine 1 comprises a turntable 10 arranged in the center of a horizontal table 11, for example of square or rectangular shape with a truncated front corner 12.

The table 11 comprises at its underside an element 300, for example of triangular shape, with a truncated corner 300a comprising fingers 301. In the example considered, these fingers 301 are two in number. The fingers 301 may be of circular cross-section and may have a first horizontal part 301a, connected to the truncated corner 300a, which is continued by a second part 301b oblique upwards and forwards, as illustrated in figure 10F . In the example considered, the fingers 301 are fixed. The fingers 301 can make it possible to maintain a corner of a sheet of F sterilization in horizontal position. The element 300 is horizontally movable (along the Y axis) between a retracted position where the truncated corner 300a of the element 300 is flush under the truncated corner 12 of the table 11, as illustrated in Figure 1A , and an extended position where the element 300 is located in front of the truncated corner 12 of the table, as illustrated in figure 1B . The element 300 can make it possible, in its retracted position, to facilitate the approach to the turntable 10 of a human operator H or any conveyor system and/or suitable automaton, in particular for placing the basket and/or removing it from the table 11. In its extended position, the element 300 can make it possible to receive a corner of a sterilization sheet F. The movement of the element 300 takes place in a controlled manner, depending on the course of the packaging process , for example using stepper motors or any other suitable drive mechanism.

Table 11 can be carried by frame 2, as shown. The presence of the truncated front corner 12 can allow a user to approach the turntable 10.

The turntable 10 is moved by a drive system, not shown, which allows it to be driven in rotation about a vertical axis by a desired angle, preferably in one direction or the other, depending on the progress of the stages of the packaging process, as will be detailed later.

The plate 10 is equipped with fingers 15a and 15b, vertically movable between a retracted position where the upper end of the fingers 15a and 15b is flush with the surface of the turntable 10 or is set back, and an extended position where the fingers 15a and 15b protrude above the surface of the turntable 10. In the example considered, these fingers 15a and 15b are four in number and their function will be detailed below. We have illustrated, figure 1C , the plate 10 with the fingers 15a in the extended position and the fingers 15b in the retracted position, and at the figure 1D , the plate 10 with the fingers 15a in the retracted position and the fingers 15b in the extended position.

The fingers 15a and 15b can be of circular cross-section for example, and their drive is carried out by any suitable mechanism, driven by an electric, pneumatic or hydraulic motor.

The machine 1 also comprises a gripping tool 110 and a bending tool 20, which are movable relative to the frame of the frame 2 during operation of the machine to perform various operations of the packaging process.

For the following description, reference is made to an orthonormal reference frame XYZ associated with the machine. The Z axis is vertical, the Y axis corresponds to a movement in depth, from front to back and vice versa, and the X axis corresponds to a lateral movement.

The gripping tool 110 is movable along the Y axis and the Z axis, in a controlled manner. To this end, the frame 2 comprises two horizontal rails 6, parallel, arranged at different heights, oriented along the Y axis, along which two respective carriages 7 move. A vertical column 8 is fixed to the carriages 7 and moves with them. A carriage 119 can move vertically on this column 8.

The movement of the carriages 7 and 119 takes place in a controlled manner, depending on the progress of the packaging process, for example using stepper motors or any other suitable drive mechanism.

If we refer to figures 2 to 4 , we see that the gripping tool 110 comprises a console 111 fixed at its base to the carriage 119. This console 111 carries a presser system 113 and a frame 112 carrying a plate 114.

The presser system 113 comprises at its lower end a horizontal pad 115, with a longitudinal axis parallel to the axis X, carried by two vertical columns 117, which are guided in their movement by a guide device 116 fitted internally with a mechanism drive which makes it possible to control the vertical displacement of the shoe 115. In the example considered, the tool 110 also comprises a pipe 118 selectively connected to a vacuum source. This pipe 118 emerges via at least one internal channel 118a on the underside of the shoe 115 by at least one orifice 118b and makes it possible, when it is connected to the vacuum source, to hold the sheet by a suction cup effect, thanks to the depression created, in particular to lift it.

The plate 114 is carried by a profile 112a which defines the lower side of the frame 112. This profile 112a has, on its upper face 112c which serves as a support for the pad 115, a groove 112b. The shoe 115 has, on its underside, a boss 115a whose profile has a complementary cross-section to that of the groove 112b, as can be seen in the figure 4A .

As can be seen on the figures 2 to 4 , the plate 114 is fixed under the profile 112a, and preferably has a thickness which decreases in distance from the profile 112a. In the example considered, the plate 114 has a rectangular shape, large side parallel to the longitudinal axis of the section 112a, which may or may not be centered relative to the latter.

The depth p ₁ of the plate 114, measured in a direction perpendicular to the longitudinal axis of the section 112a, is for example between 100 and 200 mm.

The width l ₁ of the plate 114 is for example between 150 and 250 mm.

The length of pad 115 may be slightly greater than that of plate 114, being for example between 150 and 300 mm.

Pad 115 is preferably centered within frame 112, as shown.

The plate 114 can project towards the rear of the profile 112a by a distance of between 100 and 200 mm.

The top 115c of the boss 115a can be flattened, the boss 115a projecting for example by a distance e ₂ relative to the rest of the lower face 115b of the pad 115, this distance e ₂ being for example between 0 and 30 mm.

The width l ₂ of the boss 115a can be between 0 and 30 mm.

The invention is not limited to a particular profile for the boss 115a and the latter is for example of semi-circular section, in a variant not illustrated.

We will now describe, with reference to figures 5 to 9 , the bending tool 20. The latter is carried by a console 21 which is connected to a carriage 222, which can move vertically on a vertical column 40 of the frame 2, this column 40 being carried by carriages 41 which can themselves move horizontally along the Y axis on respective parallel horizontal rails 42. Thus, the bending tool 20 can be controlled in position along the Y and Z axes.

The console 21 has a lower beam 21a with a longitudinal axis oriented parallel to the axis X.

The bending tool 20 comprises two lateral parts 22. Each lateral part 22 comprises a set of guide rods 23 which slide in guides 24 and whose movement is controlled by motors 25, for example stepper motors or brushless motors (also called "brushless" motors).

Preferably, the horizontal displacement along the X axis of the side parts 22 is carried out symmetrically towards or away from a median plane of symmetry for the bending tool 20.

The displacement stroke along the X axis of each side part 22 is for example between 0 and 250 mm. Each side part 22 may be of identical construction to that of the other side part 22.

In the example shown on the figures 5 to 9 , each side part 22 comprises a U-shaped frame 26 directed inwards, the guide rods 23 being connected to a section 26a whose longitudinal axis is parallel to the Y axis, constituting the base of the U.

The front branch 26b of the frame 26 carries at its free end a vertical plate 28, which is directed downwards. This plate 28 is preferably fixed to the front exterior face of the profile 26b.

Each side part 22 also comprises, as can be seen in the figure 6 in particular, a movable element 29, in the form of a plate in the example considered, which is articulated around an axis of rotation K parallel to the axis Y, the rotational movement of this plate 29 taking place under the action of a cylinder 30, one end 31 of which is articulated on the section 26b and the other end 32 is articulated on a pin 33 integral with the plate 29, close to the axis of rotation K.

Plate 29 is longer than plate 28, so that when folded vertically along plate 28, as shown in figure 7 , it extends under it.

In the example shown, the plates 29 are located in front of the plates 28.

As can be seen more particularly in the figure 8 , the rear profile 26c of the frame 26 comprises a clamp 50, articulated around a vertical axis of rotation R at the free end of the profile 26c. The gripper 50 comprises a U-shaped support 51, a cylinder 53 being mounted on the upper branch of the support 51. The cylinder 53 carries at its lower end a pressure roller 54, which can be lowered in the direction of the foot 55 of the support 51.

The drive in rotation of the support 51 is carried out using a cylinder 57, articulated at one end on a yoke 58, itself connected in a pivoting manner, around a vertical axis of rotation, to a base 26th. The latter is fixed to the base profile 26a, on the inside of the latter.

The opposite end of cylinder 57 is articulated at 59 on upper branch 52 of support 51.

Each side part 22 of the bending tool 20 further comprises a holding flap 70, which is articulated around a horizontal axis of rotation S, by means of articulation axes mounted respectively on the rear profile 26c and on a profile intermediate 26f, perpendicular to the base profile 26a, located substantially halfway along the latter and of shorter length than the front 26b and rear 26c profiles.

The holding flap 70 is driven in rotation about the axis S by a cylinder 73, one end of which is articulated on a yoke 74 fixed to a profile 26g, connecting perpendicularly to the base profile 26a, on the outside of the latter. this. The cylinder is connected at 75, at its other end, to a link 76 which rotates with the holding flap 70. Thus, when the cylinder 73 is actuated, the elongation or shortening of the latter is transformed into a rotation of the holding flap 70.

We will now describe, with reference to figures 10A to 10U , different stages of the operation of the machine 1 for wrapping a sterilization basket using one or more sterilization sheets.

The sterilization basket B has in the example considered a horizontal bottom B0 and four vertical uprights M1, M2, M3 and M4.

First, as shown in figure 10A , a first sterilization sheet F is brought by any suitable means, for example by being deposited manually as shown, by an operator H, on the table 11.

The sterilization sheet F can be taken from a stack of sheets, or cut to the desired format from a reel of sterilization packaging material, the unwinding of which is manual or automated.

In the case where the sterilization sheets are produced by cutting a reel of sterilization packaging material, the cutting of the sterilization sheets can be performed by a blade which is moved manually or motorized. Alternatively, the sterilization sheets are pre-cut.

As shown in figure 16 , the sterilization sheet F can be brought onto the table 11 from a reel 305 of sterilization packaging material which is unwound by a reel 304. Guide rollers 302 make it possible to guide the sterilization sheet F to a cutting device 301 enabling the sheet F to be cut to the desired size.

The dimensions of the sheet F are smaller than those of the table 11. The sheet F has for example a square or rectangular shape, the length of the sides being between 750 and 1000 mm.

The dimensions of the sterilization sheets F used are determined by the dimensions of the baskets B to be packaged.

avec L_côté = longueur du côté de la feuille de stérilisation F, l = largeur du panier de stérilisation, L = longueur du panier de stérilisation, h = hauteur du panier de stérilisation et R = valeur de non recouvrement (en mm).The machine 1 may include a system for automatically measuring the size of the sterilization basket B to be packaged, and for adapting the dimensions of the sterilization sheet accordingly. In order to make it possible to adapt the dimension of the sterilization sheets to the dimensions of the baskets, this system can be based, in the case where the sterilization sheet F is square in shape, on the formula $L_{\mathit{side}}=\frac{3\left(L+h\right)+L-\mathrm{<figure-callout\; id="2"\; label="R"\; filenames="imgf0001.png,imgf0002.png"\; state="\{\{state\}\}">R</figure-callout>}}{\sqrt{2}}$

with L _side = length of the side of the sterilization sheet F, l = width of the sterilization basket, L = length of the sterilization basket, h = height of the sterilization basket and R = non-covering value (in mm).

The sterilization sheet F is known per se, having the property of being permeable to a sterilization gas such as ethylene oxide, while constituting a sterile barrier against microorganisms.

Depending on the resistance and the elasticity sought for the packaging of the sterilization basket B, the sterilization sheet F can be, in particular chosen from a crepe paper, a reinforced paper, a cellulosic nonwoven or a sheet of the type SMS. The basis weight of the sterilization sheet F can be between 30 and 90 g/m ² , better still between 40 and 80 g/m ² . The choice of the grammage of the sterilization sheet can in particular be made according to the size of the basket to be packaged.

As shown in figures 11 and 12 , the sterilization sheet F has opposite corners F1 and F3 on the one hand, and F2 and F4 on the other hand.

The sterilization sheet F is for example that marketed by the company STERIMED in the STERISHEET range.

Once the sheet F has been deposited on the table 11, the gripping tool 110 can be activated as illustrated in figure 10B , being moved along the Y and Z axes so as to be closer to the turntable 10, which appears by transparency on the drawing under the sheet F.

Then, as shown in figure 10C , the sterilization basket B is placed on the sterilization sheet F, this basket B being brought by any suitable means, for example manually by an operator H as illustrated, or alternatively by any conveying system and/or suitable automaton. As shown in figure 12 , the sterilization basket B can be placed in the center of the sterilization sheet F, the uprights M1 and M3 being oriented perpendicular to the diagonal connecting the corners F1 and F3 of the sterilization sheet F.

The sterilization basket B contains the instruments intended to be in contact with the human body and/or used in the operating room, such as surgical instruments. These instruments are intended to be sterilized with the basket once the latter is wrapped in the sterilization sheet F.

As shown in figures 12 and 13 , the bottom B0 is preferably rectangular in shape, the opposite uprights M1 and M3, corresponding to the long sides, and M2 and M4 to the short sides. The length of the long sides is for example between 200 and 700 mm and that of the short sides between 200 and 500 mm. The height of the uprights M1 to M4 is for example between 15 and 400 mm.

The edges formed at the junction of uprights M1 to M4 are referenced A12, A23, A34 and A41. The free edges of uprights M1 to M4 are referenced A1 to A4 respectively.

The weight of the sterilization basket B with the instruments inside can be less than 16 kg, better still less than 14 kg. B sterilization baskets do not have a lid.

The basket B is placed on the turntable 10, preferably in the center of the latter, with for example the long side of the basket B oriented parallel to the front truncated corner 12 of the table 11, that is to say in the mark XYZ associated with frame 2, with its large side parallel to the X axis.

In this configuration, the line joining the opposite corners F1 and F3 of the sheet F is perpendicular to the long sides of the basket B.

You can see on the figure 10B that the sheet F, by its dimensions and its positioning on the table 11, has a first corner F1 which overflows from the front truncated corner 12.

The gripping tool 110 is brought in front of the truncated corner 12 so as to be able to grip, as illustrated in the figure 10B , the first corner F1 of the sheet F. During this operation, the folding tool 20 is inactive.

To grip the first corner F1 of the sheet F, the frame 112 of the gripping tool 110 is positioned so as to surround the corner F1 and cause the tip of the latter to extend above the profile 112a , under the shoe 15. Thus, when the latter is lowered and pressed against the upper face of the profile 112a, the corner F1 is pinched between the boss 115a and the groove 112b, which ensures its maintenance.

The first corner F1 thus maintained can then be driven backwards by the movement of the gripping tool 110 in the direction of an opposite corner F3 of the sheet F, as illustrated in figure 10E .

The sheet F is thus folded over the opening of the basket, as illustrated in figure 10E . We get a first fold.

The wedge F1 can then be released by the gripping tool 110, then the plate 114 can be moved forwards so as to push the wedge F1 under the basket B, as illustrated in figure 10F .

To help the gripping tool 110 to slide the corner F1 of the sheet F under the basket B, the fingers 15a and 15b can be actuated so that they find themselves in the extended position so as to lift the central part of the sheet F located under the basket B. This allows the passage of the corner F1 of the sheet F under the upright M3 of the basket B using the plate 114 of the gripping tool 110. A first flap R1 is thus obtained, as illustrated to the figure 14 .

This first flap R1 is located, in the view of the figure 10G , on the right side of the basket, under the M3 upright.

The bending tool can then be moved back, and the fingers 15a and 15b lowered so that they find themselves in their retracted initial position.

Once this first flap R1 has been made, it is possible, as illustrated in Fig. 10H , cause the plate 10 to rotate 90° clockwise, so as to move the sheet F and the basket B placed on it with it, and cause a corner F2 of the sheet F to protrude from the front truncated corner 12 of the table 11, as shown in Fig. 10H .

This corner F2 can be gripped by the gripping tool 110.

The side parts 22 of the bending tool 20 are used with, initially, the plates 29 in the raised position, as illustrated in the Fig. 10I , to come and press with the plates 28 a portion F6 of the sheet F against the upright M2 of the basket B. Once this pressing has been carried out, the plates 29 are pivoted downwards, as than illustrated on the figure 10J . In its pivoting movement, the plate 29 of the side part 22 of the bending tool 20 located on the left on the figure 10J causes a portion F7 of the sheet F and forms an inward fold against the upright M2 of the basket B. On the figure 10J , in order to facilitate the visualization of the operations carried out by the folding tool 20, the gripping tool 110 has not been shown in its position in which it grips the corner F2 of the sterilization sheet F.

The gripping tool 110 is then moved to drive the corner F2, so as to cover the basket B, this movement taking place concomitantly with the withdrawal of the folding tool 20, to allow the corner F2 to pass above of the basket. This leads to the configuration as shown in figure 10K . A second fold is thus formed.

The figure 10K represents basket B once this second trick has been made.

Then, as shown in figure 10L , a 180° rotation in the clockwise direction of the turntable 10 is carried out to cause the corner F4 which is opposite to the corner F2, to protrude from the front truncated corner 12 of the table.

The gripping tool 110 is positioned so as to be able to grip this corner F4.

As before, the bending tool 20 is brought forward of the upright M4 opposite to the upright M2, as illustrated in figure 10M , and the folding sequence previously described with reference to the figures 10I and 10J is reproduced, so as to form a third fold.

The figure 10N represents the basket once this third trick has been made.

Then, as shown in figure 10O , a rotation of the plate 10 by 90° in the anti-clockwise direction or a rotation of 270° in the clockwise direction is carried out, so as to bring the last corner F3 of the sheet F to protrude from the front corner 12 of the table 11 We are then in a configuration, after gripping this corner F3 by the gripping tool 110, as illustrated in Figure 10P .

The bending tool 20 is then used to press, using the plates 28, portions F8 of the sheet F against the upright M3. During this operation, the plates 29 are in the raised position, as illustrated in Figure 10P . Once this plating has been carried out, the plates 29 are pivoted downwards, so as to entrain portions F9 of the sheet F in their movement and form inward folds against the upright M3, as illustrated in figure 10Q . On the figure 10Q , in order to facilitate the visualization of operations performed by the folding tool 20, the gripping tool 110 has not been shown in its position in which it grips the corner F3 of the sterilization sheet F.

Then, the gripping tool 110 is moved so as to drive the corner F3 of the sheet F above the basket B and form a fourth fold, as illustrated in figure 10R . Concomitantly with this movement, the bending tool 20 is withdrawn.

As shown in figure 17 , after formation of the fourth ply, two portions F5 of the sterilization sheet F are delimited. These portions F5 are located on top of the sterilization basket B along the edges A2 and A4. These portions F5 are not covered by the sterilization sheet F during the formation of the fourth fold, ie when the corner F3 of the sheet F is brought to the top of the basket B. The width of each of the portions F5 at the level of the edge A1 is R/2 mm (with R = non-covering value). The value of R is chosen so as to facilitate the operation of the grippers 50. For example, a value of R=116 mm can be chosen, which means that the width of each of the portions F5 at the level of the edge A1 is R/2 = 58mm.

Then, as shown in figure 10S , the folding tool 20 is brought above the basket and the retaining flaps 70 are actuated, so as to clamp the basket B between them. The retaining flaps 70 apply, as shown in the figure 10T , on the side uprights M3 and M4 of the basket.

The clamps 50 are then pivoted inwards, as illustrated in figure 9 , so that the feet 55 of the support 51 engage under portions F5 of the packaging covering the top of the basket B. Then, the cylinders 53 are actuated so as to lower the pressure rollers 54 and thus pinch these portions of the wrapper that span over 55 feet.

The folding tool 20 is then actuated so as to slightly lift the portions F5 thus gripped.

The clamps 50 can pivot away from each other so as to tension the portions F5 which extend between them. We thus end up with portions F5 which are kept taut between the clamps 50, and slightly raised relative to the rest of the basket B, which provides an opening into which the plate 114 can be introduced, to push the last corner F3 of the sheet F in this opening. A second flap R2 is obtained, as illustrated in figure 15 . In this figure, we have shown the possibility for the portions F5 of the packaging to be formed by several superposed thicknesses of the sheet F, due to the preceding folding operations.

Then, the pinch rollers 54 can be raised so as to release the sheet F and the clamps 50 pivoted outwards, as illustrated in figure 8 , to clear 55 feet.

The tools 110 and 20 can then be moved away from the packed basket, the holding flaps 70 moving apart to release it.

The basket can then be removed from the table 11 by any suitable means, for example by a human operator H as illustrated in figure 10U or by any suitable automaton or conveyor.

The machine 1 can be used to wrap sterilization baskets, sequentially, in a double wrap, consisting for example of two sterilization sheets. The basket to be wrapped is then placed on two superposed sterilization sheets and the operating sequence of the machine 1 previously described for wrapping a sterilization basket with a sterilization sheet is repeated twice. When wrapping the basket with the first sterilization sheet, the gripping tool, by a suction cup effect, allows the separation of the first and second sterilization sheet, which allows only the first sheet to be gripped by the gripping tool.

Alternatively, the machine 1 is used to wrap sterilization baskets in a double wrapper in a single step, using for example two sterilization sheets secured to each other, the two sterilization sheets being joined together at the level of one or more binding sites.

In another variant, the machine is used for packaging an object, in particular a sterilization basket, with a folding technique other than Pasteur type folding, such as the envelope, square, American type folding technique. or any other bending technique described in ANSI/AAMI ST79:2010/A4:2013.

The invention is not limited to the example which has just been described. For example, in a variant, the two lateral parts 22 of the bending tool 20 move independently of each other along the X axis.

Alternatively, machine 1 is used to wrap sterilization baskets with lids.

The machine 1 can also be used to package ancillaries characterized by low rims, or even by the absence of rims.

The term "comprising" must be understood with its current acceptance, that is to say as being synonymous with "comprising at least one", unless the contrary is specified.

Claims (15)

1. A machine (1) for packaging an object, notably a sterilization basket (B), with at least one sterilization packaging material, notably a sterilization sheet (F), the machine comprising:

   - a plate (10) configured to receive the sterilization packaging material (F) and the object to be packaged (B) placed on top,

   - a gripping tool (110) configured to grasp hold of a corner (F1; F2; F3; F4) of the sterilization packaging material (F), the gripping tool (110) and the plate (10) being able to move relative to one another so as to allow the gripping tool (110) to bring the corner over the top of the object (B) and thus form at least one fold covering the object (B),
   characterized in that the plate (10) and the gripping tool (110) are able to rotate one relative to the other and the plate (10) is able to rotate about a vertical axis of rotation (Z).
2. The machine as claimed in claim 1, the gripping tool (110) being able to move vertically and along at least one horizontal axis (Y), the gripping tool (110) preferentially comprising a pressing system (113) comprising a shoe (115) able to move vertically facing a bearing surface (112c), the gripping tool (110) preferentially having a surface (115b) onto which there opens at least one orifice (118b) selectively connected to a source of vacuum, notably a depression created through a Venturi effect, the orifice (118b) preferentially opening onto the underside face of the shoe (115), the gripping tool (110) preferentially comprising a member (114) for pushing the sterilization packaging material (F) under the object (B), said member (114) preferentially taking the form of a horizontal plate mounted at the lower end of the gripping tool (110), this plate (114) tapering preferably toward its distal end.
3. The machine as claimed in claim 1 or claim 2, the plate (10) comprising at least one finger (15) able to move vertically so as to lift the object (B) and the sterilization packaging material (F) locally.
4. The machine as claimed in any one of the preceding claims, comprising a table (11) extending around the plate (10), with at least one truncated corner (12).
5. The machine as claimed in any one of the preceding claims, comprising at least one holding and/or folding tool (20), the holding and/or folding tool (20) and the plate (10) being able to move one relative to the other, the holding and/or folding tool (20) being designed to act on the sterilization packaging material (F) when at least one fold has been formed along one side (M1) of the object, by using at least one smoothing-down member (28) to smooth the sterilization packaging material (F) down along at least one adjacent side (M3) of the object, near the side along which the fold has been formed and around which the next fold is to be made, the holding and/or folding tool (20) preferably comprising a pushing member (29), able to move toward the inside in order to push inward a portion (F7) of the sterilization packaging material (F) that extends along the fold already formed, facing the portion (F6) of the sterilization packaging material (F) that has already been smoothed down against the object (B), the smoothing-down member (28) preferably taking the form of a vertical fixed plate, and the pushing member (29) preferably the form of a vertical plate, able to move about a horizontal axis of rotation (K), preferably between a raised position and a lowered position in which it is superposed at least partially with the fixed plate.
6. The machine as claimed in any one of the preceding claims, comprising at least two grippers (50) making it possible to grasp hold of at least one portion (F5) of the packaging between them and lift it or them so as to allow a corner of the sterilization packaging material (F) to be pushed under the portion or portions (F5) thus lifted, the two grippers (50) being preferably mounted in such a way as to be able to move away from one another and keep the grasped portion or portions (F5) taut.
7. The machine as claimed in claim 6, dependent on claim 5, the grippers being mounted with the ability to pivot on the holding and/or folding tool (20).
8. The machine as claimed in any one of the preceding claims, comprising an object holding system comprising at least two mobile holding members (70), between which the object (B) can be held laterally.
9. The machine as claimed in claim 8, dependent on claim 5, the holding members (70) being formed by two pivoting panels (70) which are mounted on the folding and/or holding tool (20).
10. The machine as claimed in any one of claims 6 to 9, dependent on any claim 5, the holding and/or folding tool (20) comprising two lateral parts (22) each comprising a U-shaped frame, with a front profile section (26b) bearing one of the pushing members (29) and a rear profile section (26c) bearing one of the grippers (50), each lateral part preferably comprising an intermediate profile section (26f), each of the panels (70) being articulated between this intermediate profile section (26f) and the rear profile section (26c).
11. The machine as claimed in any one of the preceding claims, comprising a system for checking the conformity of the composition of the contents of the object (B) before and/or after packaging, notably by laser analysis or by weighing the object (B), and/or comprising a system for labeling and/or marking the object (B), notably by laser or ink-jet printing, before and/or after packaging, notably providing traceability thereof, and/or comprising a system for validating the closure of the sterilization packaging wrapping the object (B), and notably a system for validating the closure of a surgical pack, and/or comprising a system for recording, storing and managing data providing traceability of the operations performed by the machine (1), and/or comprising at least one reel (304) for unrolling a roll (305) of a sterilization packaging material (F) and a cutting device (301) for cutting this sterilization packaging material (F), and/or comprising a system for closing the packaging with at least one adhesive tape that may or may not contain at least one sterilization indicator, and/or comprising at least one reel for unrolling a roll of adhesive tape which may or may not contain at least one sterilization indicator, and a cutting device for cutting this tape in order to close the package.
12. An assembly comprising a machine as claimed in any one of the preceding claims, at least one object (B) to be packaged and at least one sterilization packaging material (F) for packaging the object (B).
13. A method for packaging an object, preferably a sterilization basket (B), with at least one sterilization packaging material (F), notably a sterilization sheet, the packaging being performed using a machine (1) as claimed in any one of claims 1 to 28, wherein at least four folds are formed by successively grasping hold of one corner of the sterilization packaging material (F) using the gripping tool (110) and by bringing the sterilization packaging material (F), via this corner, over the object (B), method wherein, preferentially, between two folds, the sterilization packaging material (F) with the object (B) on top is turned relative to the gripping tool (110), preferably by rotating the plate (10), notably by 90°, method wherein, preferentially, after the first fold is formed, the first corner (F1) that was grasped in order to make this first fold, is pushed under the object (B), method wherein, preferentially, the sterilization packaging material (F) is held against the object (B) and a fold previously formed is pushed laterally inward.
14. The packaging method as claimed in claim 13, the packaging being performed using two sterilization packaging materials (F), notably sequentially.
15. The packaging method as claimed in claim 13, the packaging being performed using two sterilization packaging materials (F), these two sterilization packaging materials (F) being joined together at one or more connection sites and the packaging being performed with the two sterilization packaging materials (F) simultaneously.

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