专利摘要:
Machine (1) for packaging with at least one sterilization packaging material, in particular a sterilization sheet (F), of an object, in particular a sterilization basket (B), comprising: - a tray (10) for receiving the sterilization packaging material (F) and the object to be packaged (B) placed thereon, - a gripping tool (110) configured to grip a corner (F1; F2; F3; F4) of the sterilization packaging material (F), the gripping tool (110) and the tray (10) being movable l '' relatively to each other so as to allow the gripping tool (110) to drive the corner above the object (B) and thus form at least one fold covering the object (B) .
公开号:FR3075181A1
申请号:FR1762381
申请日:2017-12-18
公开日:2019-06-21
发明作者:Clementine Auffray;Christophe Simon;Laurent LEBRETTE
申请人:Sterimed Sas;
IPC主号:
专利说明:

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 theaters, such as surgical instruments, are generally packaged in sterilization baskets (also called trays) which are then packaged with sterile barrier systems.
These can be of several types: bags, pouches, sachets, sleeves, envelopes, containers or sterilization sheets.
The choice of packaging depends on the size of the devices,. their weight and the risks associated with their handling and transport.
Packages in the form of sachets or envelopes are limited in capacity and do not allow the reception of bulky and / or heavy objects.
Given their low cost and their adaptability to the different baskets available, sterilization sheets are commonly used in sterilization centers. The sterilization sheets are in particular particularly suitable for packaging bulky and / or heavy objects such as the 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 folded repeatedly so as to obtain a tortuosity sufficient 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 maintaining sterility.
It is known to wrap the sterilization baskets in a double packaging, 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 stages, 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 of sterility, constitutes an impermeable barrier against microorganisms around the sterilization basket. The secondary packaging, which surrounds the primary packaging, is designed to protect the primary packaging and its contents up to 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, improves the maintenance of sterility. However, it requires a sequential folding operation, which has the disadvantage of lengthening the time of the folding operation performed by the operator.
Applications EP 0 707 460 A1 and EP 1 362 557 A1 teach the possibility of wrapping the sterilization baskets in a double package, the folding operation being carried out in a single step, which saves time and simplicity of implementation of the folding operation. The sterilization package then consists of two sterilization sheets fixed 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, a puncture, a thermal or ultrasonic bond. For example, the sterilization package consists of two polypropylene sterilization sheets of SMS structure (Spunbond-Meltblown-Spunbond) which are heat-sealed together at the edges.
The methods of packaging baskets with sterilization sheets remain manual to this day. The quality of the folding, and therefore the maintenance of sterility, therefore has the disadvantage of being very dependent on human intervention. Furthermore, the folding operation requires operator training. This folding operation is therefore costly in time and labor, in addition to being repetitive and tedious.
A second technique consists in putting the object to be sterilized in a peelable package. Once the item is in the package, the package is sealed and then subjected to the sterilization step. Packages are most often made up of two separate sheets made of different materials. One of the leaves is most often 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 the peelable packaging is made up of two heat-sealed sheets, the mechanical resistance can be limited by the mechanical resistance of the weld which provides the junction between the two sheets, or by the resistance of the packaging itself. This technique is therefore not the first choice for packaging bulky and / or heavy sterilization baskets.
The invention aims to further improve the devices and methods used to package sterilization baskets, and in particular to remedy all or part of the above drawbacks. It achieves this by means of a machine for packaging with at least one sterilization packaging material, in particular a sterilization sheet, of an object, in particular a sterilization basket, comprising:
- a tray to receive the sterilization packaging material and the object to be wrapped placed on it,
- a gripping tool configured to grip a corner of the sterilization packaging material, the gripping tool and the tray being movable relative to each other so as to allow the gripping tool to drive the corner above the object and thus form at least one fold covering the object.
The machine according to the invention allows packaging with at least one packaging material for sterilization of an object which may contain medical devices, in particular reusable, freshly washed and disinfected. These medical devices can be elements intended to be in contact with the human body and / or used in operating theaters, 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 health establishments, and / or by manufacturers of surgical packs.
The machine according to the invention can be used to package an object, such as a sterilization basket, whether it is a standardized basket such as a basket meeting ISO 3394 or DIN 58952, 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 sterilization basket, in particular by transferring part of the available labor to d other tasks.
On the other hand, the risk of human error is reduced.
The risk of developing musculoskeletal disorders is also reduced.
Another advantage is that, in terms of productivity, the automated folding operation performed by the machine according to the invention is at least as fast as a manual folding operation performed by a human operator.
By "sterilization packaging material" is meant 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 dry heat and / or by low-temperature formulated steam (LTFS process) and / or any other oxidative sterilization process or not, while providing the bacterial barrier required to allow sterility to be maintained during the period of claimed life for the packed object. The sterilization packaging material is for example a sterilization sheet and must therefore meet the general requirements described in international standard ISO 11607-1: 2006 / A1: 2014: Packaging for terminally sterilized medical devices - Part 1: Requirements relating to materials, sterile barrier systems and packaging systems defining, in particular, the microbial barrier properties and compatibility with the sterilization process. The performance of sterilization sheets is also described in European standard EN 868-2: 2017: "Packaging materials and systems for terminally sterilized medical devices - Part 2: sterilization shell - Requirements and test methods" . The sterilization packaging material can also be a sterile drape according to ISO 13795 and / or AAMI PB 70 standards. The sterilization packaging material can also be a sterile presentation drape (also called "inner wrap") allowing the aseptic transfer of medical devices. The sterilization packaging material may or may not be a shape memory sterilization packaging material. In the case where the sterilization packaging material is a shape memory sterilization packaging material, the latter may be cellulose-based.
Preferably, the plate and the gripping tool are provided to rotate relative to one another. This makes it possible to use only one gripping tool to carry out all of the folding steps, therefore to have a simpler construction machine.
Preferably, the plate is rotatable about 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 chassis, without rotational movement. This approach simplifies the machine by reducing the number of axes of movement necessary for moving the machine tools. This thus minimizes 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 shoe movable vertically opposite a support surface. This allows the sterilization packaging material to be held 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 carried out with several sterilization packages, for example a double packaging produced with two sterilization sheets sequentially, this allows the sterilization sheets to be separated by a suction effect. This vacuum source allows optimization of the grip of the sterilization packaging material as well as its unit selection.
In an exemplary embodiment, the orifice opens onto the underside of the shoe of the gripping tool.
Preferably, the gripping tool includes a member for pushing the sterilization packaging material under the object. This makes it possible to form a flap for holding a fold previously formed.
This member can be in the form of a horizontal plate mounted at the lower end of the gripping tool, this plate preferably thinning towards its distal edge. Thus, the plate can 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 tray includes at least one vertically movable finger, for lifting the object and the packaging material for sterilization locally. This finger can be actuated when the aforementioned plate is used to push the sterilization packaging material under the object.
Preferably, the machine has a table extending around the tray. Preferably, the sterilization packaging material is larger than the tray, so that its four corners extend beyond the tray. The table accommodates these corners of the sterilization packaging material.
Preferably, the table has at least one truncated corner. Thus, the corner of the sterilization packaging material which is in this truncated corner does not rest on the table, but extends in overhang beyond this truncated corner, which facilitates the accessibility of the platform for operators, when the placement and removal of the object is not automated, or to any suitable conveying and / or automated system.
The machine can comprise at least one holding and / or folding tool, the holding and / or folding tool and the plate being able to move relative to the other, the holding tool and / or fold being arranged to intervene on the sterilization packaging material when at least one fold has been formed along one side of the object, coming to press using at least one pressing member the sterilization packaging material on at least one adjacent side of the object, near the side along which the fold has been formed and around which the next fold is to be made. Such a holding and / or folding tool facilitates the production of the other three folds after the first, ensuring that the previously formed fold is brought inward and pressed against the object when the next 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, in look at 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 pushing 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 plating member and / or its pushing member, makes it possible to solve the problems of using packaging materials of 3Ό shape memory sterilization, such as materials cellulose-based sterilization packaging, especially crepe papers, reinforced papers and / or cellulose 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 (s) thus raised. . This or these packaging portions may be formed from one or more thicknesses of the sterilization packaging material, which are found to cover the object as a result of the preceding folding operations.
The two clamps can be mounted so that they can move away from each other and stretch the gripped portion (s). This facilitates the engagement of a portion of the sterilization packaging material under the portion (s) thus stretched and raised. Preferably, the clamps are pivotally mounted on the holding and / or folding tool.
Preferably, the machine comprises an object holding system 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 must be formed.
The lateral holding members can be formed by two pivoting flaps, mounted on the folding and / or holding tool.
Thus, the latter can carry several organs implemented at different stages, which makes it possible to pool for all these organs the drive mechanism relative to the chassis, therefore simplifying the machine and optimizing its cost.
In an exemplary implementation of the invention, the holding and / or folding tool comprises two lateral parts each comprising a U-shaped frame, with a front section carrying one of the thrust members and a rear profile carrying one of the clamps.
Each side part may include an intermediate section, each of the flaps being articulated between this intermediate section and the rear section.
The machine may include a system for verifying the positioning of the object in relation to the sterilization packaging material and / or a system for verifying the positioning of the sterilization packaging material in relation to the tray. This or these verification systems are for example optical, and are based on image processing by one or more cameras.
The machine may include a system for verifying the conformity of the composition of the content 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 include 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 package enveloping the object, and in particular a system for validating the closure of a surgical pack. This provides repeatable and reproducible closings according to international validation standards ISO 11607-2: 2016.
The machine may include a system for closing the packaging with at least one adhesive tape containing or not containing at least one sterilization indicator. The closure system meets the requirements of ISO 11607-1, which notably defines a closure system with a tamper-evident device. The closure system operates until the point of use.
The machine may include at least one reel for unwinding a roll of adhesive tape containing or not 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.
As a variant, the sterilization packaging materials are precut, 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 packed.
The subject of the invention is also an assembly comprising a machine according to the invention, as defined above, at least one object to be packaged, preferably a sterilization basket, and at least one sterilization packaging material, of preferably a sterilization sheet to wrap the object.
The subject of the invention is also a method of packaging with at least one sterilization packaging material, preferably an object sterilization sheet, preferably a sterilization basket, the packaging being carried out using 'a machine according to the invention, as defined above.
In particular, during this process, at least four folds can be formed by successively gripping a corner of the sterilization packaging material using the gripping tool and by moving the sterilization packaging material by this corner above the object.
Advantageously, between two folds, the sterilization packaging material is rotated with the object above relative to the gripping tool, preferably by rotating the plate, in particular by 90 °.
After the first fold is formed, you can push the first corner that has been grabbed 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 back laterally inwards.
Preferably also, after the last fold has been formed, at least a portion of the sterilization packaging material located on top of the object, formed during a previous fold, is grabbed and the last fold is folded under this or these portions. To form this flap, said portion (s) is preferably stretched between two clamps, and it is 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 by pushing the first corner under the object. During this operation, the holding and / or folding tool can be used to both grip said portion (s) with the pliers, and block the object laterally between the aforementioned lateral holding members.
Preferably, the machine is thus used to carry out a Pasteur type folding. This type of folding reduces the size of the machine and the area of 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 amount of waste produced. In addition, Pasteur-type folding is recognized by the various standards for sterilization.
The packaging can be done with one or, better, two sterilization packaging materials.
In this case, for example, the packaging is carried out sequentially, by packaging the object a first time with a first sterilization packaging material, then by packaging the object thus packed a second time using 'a second sterilization packaging material.
It can still be done at once using sterilization packaging materials joined together at one or more binding sites.
The packaging can be carried out with two sterilization packaging materials, these two sterilization packaging materials being able to be joined together at one or more binding sites and the packaging can be carried out simultaneously with the two sterilization packaging materials.
The invention will be better understood on reading the detailed description which follows, of an example of non-limiting implementation thereof, and on examining the appended drawing, in which:
- Figures IA to 1D schematically and in perspective show an example of a machine according to the invention,
- Figures 2 and 3 show the gripping tool of the machine of Figure 1 in isolation,
- Figure 4 shows a detail of the gripping tool,
FIG. 4A is a cross section in plane A of FIG. 4,
FIGS. 5 to 9 show the holding and / or folding tool in isolation, in different configurations,
FIGS. 10A to 10U illustrate different stages of the operation of the machine for packaging a sterilization basket,
FIG. 11 represents the sterilization sheet F in isolation from above,
FIG. 12 is a view similar to FIG. 11 with the sterilization basket B placed on the sheet,
FIG. 13 represents the sterilization basket B in perspective in isolation,
FIGS. 14 and 15 are schematic and partial cross sections, according to XII-XII of FIG. 12, after the first and second flaps have been formed respectively,
FIG. 16 illustrates a system for feeding the machine with sterilization sheets, and
- 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 FIG. 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 into a production line and connected to conveyors and / or automatic machines making it possible to bring the sterilization sheets and the baskets to be packed as well as, if necessary, to recover the packed baskets. These additional elements have not been shown in the drawing, for the sake of clarity.
The term “basket” here designates any receptacle capable of receiving objects to be sterilized.
The machine 1 comprises a turntable 10 disposed in the center of a horizontal table 11, for example of square or rectangular shape with a truncated front corner 12.
The table 11 has at its lower face 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 continues with a second part 301b oblique upwards and forwards, as illustrated in FIG. 10F. In the example considered, the fingers 301 are fixed. The fingers 301 can be used to maintain a corner of a sterilization sheet F in a horizontal position. The element 300 is movable horizontally (along the Y axis) between a retracted position where the truncated corner 300a of the element 300 is flush with the truncated corner 12 of the table 11, as illustrated in FIG. 1A, and a position outlet where the element 300 is located in front of the truncated corner 12 of the table, as illustrated in FIG. 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 suitable conveying and / or automatic system, 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.
The table 11 can be carried by the chassis 2, as illustrated. The presence of the truncated front corner 12 can allow a user to approach the turntable 10.
The turntable 10 is driven by a drive system, not shown, which makes it possible to drive it 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, movable vertically 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. Illustrated in FIG. 1C, the plate 10 with the fingers 15a in the extended position and the fingers 15b in the retracted position, and in FIG. 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 includes a gripping tool 110 and a folding tool 20, which are movable relative to the frame of the chassis 2 during the operation of the machine to perform different 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 displacement in depth, from front to back and vice versa, and the X axis to a lateral displacement.
The gripping tool 110 is movable along the Y axis and the Z axis, in a controlled manner. For this purpose, the chassis 2 comprises two horizontal rails 6, parallel, disposed at different heights, oriented along the axis Y, along which move two respective carriages 7. 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 course of the packaging process, for example using stepping 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 to its base to the carriage 119. This console 111 carries a pressure system 113 and a frame 112 carrying a plate 114.
The pressing system 113 comprises at its lower end a horizontal shoe 115, of longitudinal axis parallel to the axis X, carried by two vertical columns 117, which are guided in their movement by a guide device 116 provided internally with a mechanism drive which controls the vertical movement of the shoe 115. In the example considered, the tool 110 also includes a pipe 118 selectively connected to a source of vacuum. This pipe 118 opens via at least one internal channel 118a on the underside of the shoe 115 by at least one orifice 118b and allows, when it is connected to the vacuum source, to hold the sheet by a suction effect, thanks to the depression created, in particular to raise it.
The plate 114 is carried by a section 112a which defines the lower side of the frame 112. This section 112a has, on its upper face 112c which serves to support the shoe 115, a groove 112b. The shoe 115 has, on its underside, a boss 115a whose profile has a cross section complementary to that of the groove 112b, as can be seen in FIG. 4A.
As can be seen in Figures 2 to 4, the plate 114 is fixed under the profile 112a, and preferably has a thickness which decreases away from the profile 112a. In the example considered, the plate 114 has a rectangular shape, with a long side parallel to the longitudinal axis of the profile 112a, which may or may not be centered relative to the latter.
The depth p of the plate 114, measured in a direction perpendicular to the longitudinal axis of the profile 112a, is for example between 100 and 200 mm.
The width / i of the plate 114 is for example between 150 and 250 mm.
The length of the shoe 115 may be slightly greater than that of the plate
114, being for example between 150 and 300 mm.
The shoe 115 is preferably centered within the frame 112, as illustrated.
The plate 114 can project towards the rear of the profile 112a from a distance of between 100 and 200 mm.
The top 115c of the boss 115a can be flattened, the boss 115a for example projecting by a distance ei with respect to the rest of the lower face 115b of the shoe
115, this distance ei being for example between 0 and 30 mm.
The width h 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 this is for example of semicircular section, in a variant not illustrated.
We will now describe, with reference to FIGS. 5 to 9, the folding 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 chassis 2 , this column 40 being carried by the carriages 41 which themselves can move horizontally along the Y axis on respective parallel horizontal rails 42. Thus, the folding 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 X axis.
The folding 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 stepping motors or brushless motors (also called brushless motors).
Preferably, the horizontal displacement along the axis X of the lateral parts 22 is effected symmetrically in approach or in distance, relative to a median plane of symmetry for the folding tool 20.
The displacement travel along the axis X of each lateral part 22 is for example between 0 and 250 mm. Each side part 22 can be of identical construction to that of the other side part 22.
In the example illustrated in FIGS. 5 to 9, each lateral part 22 comprises a U-shaped frame 26 directed inwards, the guide rods 23 connecting to a profile 26a whose longitudinal axis is parallel to the axis Y, 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 on the outer front face of the profile 26b.
Each lateral part 22 also comprises, as can be seen in FIG. 6 in particular, a mobile 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 being effected by the action of a jack 30, one end 31 of which is articulated on the profile 26b and the other end 32 of which is articulated on an axis 33 integral with the plate 29, near the axis of rotation K.
The plate 29 is longer than that of the plate 28, so that when it is folded vertically along the plate 28, as illustrated in FIG. 7, it extends below it.
In the example illustrated, the plates 29 are located in front of the plates 28.
As can be seen more particularly in FIG. 8, the rear section 26c of the frame 26 comprises a clamp 50, articulated around a vertical axis of rotation R at the free end of the section 26c. The clamp 50 comprises a U-shaped support 51, a jack 53 being mounted on the upper branch of the support 51. The jack 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 support 51 is driven in rotation using a jack 57, articulated at one end on a yoke 58, itself pivotally connected, around a vertical axis of rotation, to a base 26th. The latter is fixed to the base profile 26a, on the inner side thereof.
The opposite end of the jack 57 is articulated at 59 on the upper branch 52 of the support 51.
Each lateral part 22 of the folding tool 20 also 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 section 26c and on a section intermediate 26f, perpendicular to the base section 26a, located substantially mid-length thereof and shorter in length than the front sections 26b and rear 26c.
The holding flap 70 is rotated about the axis S by a jack 73, one end of which is articulated on a clevis 74 fixed on 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 thereof is transformed into a rotation of the flap holding 70.
We will now describe, with reference to FIGS. 10A to 10U, different stages of the operation of the machine 1 for packaging 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 Ml, M2, M3 and M4.
First, as illustrated in FIG. 10A, a first sterilization sheet F is brought by any suitable means, for example by being deposited manually as illustrated, 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 process of which is manual or automated.
In the case where the sterilization sheets are produced by cutting a coil of sterilization packaging material, the cutting of the sterilization sheets can be carried out by a blade which is moved manually or by motor. Alternatively, the sterilization sheets are precut.
As illustrated in FIG. 16, the sterilization sheet F can be brought to the table 11 from a reel 305 of sterilization packaging material which is unwound by a reel 304. Guide rollers 302 allow guide the sterilization sheet F to a cutting device 301 making it possible to cut the sheet F to the desired size.
The dimensions of the sheet F are smaller than those of the table 1L 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.
The machine 1 may include an automatic measurement system for the size of the sterilization basket B to be packed, and for adapting the dimensions of the sterilization sheet accordingly. In order to allow the size of the sterilization sheets to be adapted to the dimensions of the baskets, this system can be based, in the case where the sterilization sheet F is square, on the formula L side = =- with V2 ù C removed = 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-recovery value (in mm).
The sterilization sheet F is known in itself, 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 cellulose nonwoven or a sheet of the type SMS. The basis weight of the F sterilization sheet may be between 30 and 90g / m 2, preferably between 40 and 80 g / m 2. The choice of grammage of the sterilization sheet can in particular be made according to the size of the basket to be packed.
As illustrated in FIGS. 11 and 12, the sterilization sheet F has opposite corners Fl and F3 on the one hand, and F2 and F4 on the other hand.
The sterilization sheet F is for example that sold by the company STERIMED in the STERISHEET range.
Once the sheet F placed on the table 11, the gripping tool 110 can be activated as illustrated in FIG. 10B, by being displaced along the axes Y and Z so as to be brought closer to the turntable 10, which appears by transparency in the drawing under sheet F.
Then, as illustrated in FIG. 10C, the sterilization basket B is placed on the sterilization sheet F, this basket B being brought in by any suitable means, for example manually by an operator H as illustrated, or alternatively by any conveyor and / or adapted automaton. As illustrated in FIG. 12, the sterilization basket B can be placed in the center of the sterilization sheet F, the uprights Ml and M3 being oriented perpendicular to the diagonal connecting the corners Fl and F3 of the sterilization sheet F.
The sterilization basket B contains 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 by the sterilization sheet F.
As illustrated in FIGS. 12 and 13, the bottom B0 is preferably rectangular in shape, the opposite uprights Ml 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 Ml to M4 is for example between 15 and 400 mm.
The edges formed at the junction of the uprights Ml to M4 are referenced Al 2, A23, A34 and A41. The free edges of the uprights Ml 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. The sterilization baskets B do not have a cover.
Basket B is placed on the turntable 10, preferably in the center of the latter, for example with the long side of basket B oriented parallel to the front truncated corner 12 of the table 11, that is to say in the reference XYZ associated with chassis 2, with its large side parallel to the X axis.
In this configuration, the straight line joining the opposite corners F1 and F3 of the sheet F is perpendicular to the long sides of the basket B.
It can be seen in FIG. 10B that the sheet F, by its dimensions and its positioning on the table 11, has a first corner F1 which projects beyond the front truncated corner 12.
The gripping tool 110 is brought in front of the truncated corner 12 so as to be able to grasp, as illustrated in FIG. 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 ensure that the point of the latter extends above the profile 112a , under the pad 15. Thus, when the latter is lowered and pressed against the upper face of the section 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 towards the rear by the movement of the gripping tool 110 in the direction of an opposite corner F3 of the sheet F, as illustrated in FIG. 10E.
The sheet F is thus folded over the opening of the basket, as illustrated in FIG. 10E. We get a first fold.
The corner Fl can then be released by the gripping tool 110, then the plate 114 can be moved forward so as to push the corner Fl under the basket B, as illustrated in FIG. 10F.
To help the gripping tool 110 to slide the corner Fl of the sheet F under the basket B, the fingers 15a and 15b can be actuated so that they are in the extended position so as to raise the central part of the sheet F located under the basket B. This allows the corner Fl of the sheet F to pass under the upright M3 of the basket B using the plate 114 of the gripping tool 110. A first flap RI is thus obtained, as illustrated in Figure 14.
This first flap RI is located, in the view of FIG. 10G, on the right side of the basket, under the upright M3.
The folding tool can then be moved back, and the fingers 15a and 15b lowered so that they return to their original retracted position.
Once this first flap RI has been made, it is possible, as illustrated in FIG. 10H, to make the plate 10 rotate 90 ° clockwise, so as to move with it the sheet F and the basket B placed on it, and bring a corner F2 of the sheet F to protrude from the front truncated corner 12 of the table 11, as illustrated in FIG. 10H.
This corner F2 can be gripped by the gripping tool 110.
The lateral parts 22 of the folding tool 20 are used with, initially, the plates 29 in the raised position, as illustrated in FIG. 101, to come to press with the plates 28 a portion F6 of the sheet F against the upright M2 of the basket B. Once this plating has been made, the plates 29 are pivoted downwards, as illustrated in FIG. 10J. In its pivoting movement, the plate 29 of the lateral part 22 of the folding tool 20 located on the left in FIG. 10J drives a portion F7 of the sheet F and forms an inward fold against the upright M2 of the basket B. In FIG. 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 grasps the corner F2 of the sterilization sheet F.
The gripping tool 110 is then moved to drive the corner F2, so as to come 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 over from the basket. This leads to the configuration as illustrated in Figure 10K. A second fold is thus formed.
FIG. 10K represents the basket B once this second fold has been produced.
Then, as illustrated in FIG. 10L, a rotation of 180 ° clockwise of the turntable 10 is carried out to bring the corner F4 which is opposite 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 grasp this corner F4.
As before, the folding tool 20 is brought in front of the upright M4 opposite the upright M2, as illustrated in FIG. 10M, and the folding sequence described previously with reference to FIGS. 101 and 10J is reproduced, from so as to form a third fold.
Figure 10N shows the basket after this third fold.
Then, as illustrated in FIG. 10O, a rotation of the plate 10 by 90 ° anti-clockwise or a rotation of 270 ° clockwise is carried out, so as to bring the last corner F3 of the sheet F to exceed of the front corner 12 of the table 1L We are then in a configuration, after gripping this corner F3 by the gripping tool 110, as illustrated in FIG. 10P.
The folding tool 20 is then used to press using the plates 28 of the portions F8 of the sheet F against the upright M3. During this operation, the plates 29 are in the raised position, as illustrated in FIG. 10P. Once this plating has been carried out, the plates 29 are pivoted downwards, so as to cause in their movement portions F9 of the sheet F and form folds inwards against the upright M3, as illustrated in FIG. 10Q . In FIG. 10Q, 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 grasps 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 the figure
10R. Concurrently with this movement, the folding tool 20 is withdrawn.
As illustrated in FIG. 17, after the fourth fold has been formed, two portions F5 of the sterilization sheet F are delimited. These portions F5 are located on the 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 the edge Al is R / 2 mm (with R = non-recovery value). The value of R is chosen so as to facilitate the operation of the clamps 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 edge Al is R / 2 = 58 mm.
Then, as illustrated in FIG. 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 holding flaps 70 are applied, as illustrated in FIG. 10T, to the lateral uprights M3 and M4 of the basket.
The clamps 50 are then pivoted inwards, as illustrated in FIG. 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 jacks 53 are actuated so as to lower the pressure rollers 54 and thus pinch these portions of the packaging which extend above the feet 55.
The folding tool 20 is then actuated so as to slightly lift the portions F5 thus captured.
The clamps 50 can pivot away from one another so as to tension the portions F5 which extend between them. We thus end up with portions F5 which are held taut between the clamps 50, and slightly raised relative to the rest of the basket B, which provides an opening in 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 FIG. 15. In this figure, the possibility has been illustrated for the portions F5 of the packaging to be formed by several superimposed thicknesses of the sheet F, due to the folding operations. preceding.
Then, the pressure rollers 54 can be raised so as to release the sheet.
F and the clamps 50 pivoted outwards, as illustrated in FIG. 8, to release the feet 55.
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 FIG. 10U or by any suitable automaton or conveyor.
The machine 1 can be used to wrap sterilization baskets, sequentially, in a double packaging, consisting for example of two sterilization sheets. The basket to be packed is then placed on two superimposed sterilization sheets and the operating sequence of the machine 1 previously described for packaging a sterilization basket with a sterilization sheet is repeated twice. When packing the basket with the first sterilization sheet, the gripping tool, by a suction effect, allows the separation of the first and second sterilization sheet, which allows that only the first sheet is gripped by the gripping tool.
Alternatively, the machine 1 is used to wrap sterilization baskets in a double package in a single step, for example using two sterilization sheets integral with one another, the two sterilization sheets being joined together at the level of one or more link sites.
In another variant, the machine is used for packaging an object, in particular a sterilization basket, with a folding technique other than folding of the Pasteur type, such as the folding technique of the envelope type, square, American or any other folding 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 folding tool 20 move independently of one another along the axis X.
In a variant, the machine 1 is used to package sterilization baskets with a lid.
The machine 1 can also be used to package ancillaries characterized by flanges of low height, or even by the absence of flanges.
The term "comprising" should be understood with its current acceptance, that is to say as being synonymous with "comprising at least one", unless otherwise specified.
权利要求:
Claims (35)
[1" id="c-fr-0001]
1. Machine (1) for packaging with at least one sterilization packaging material, in particular a sterilization sheet (F), of an object, in particular a sterilization basket (B), comprising:
- a tray (10) to receive the sterilization packaging material (F) and the object to be packaged (B) placed on it,
a gripping tool (110) configured to grip a corner (F1; F2; F3; F4) of the sterilization packaging material (F), the gripping tool (110) and the tray (10) being movable l '' relatively to each other so as to allow the gripping tool (110) to drive the corner above the object (B) and thus form at least one fold covering the object (B) .
[2" id="c-fr-0002]
2. Machine according to claim 1, the plate (10) and the gripping tool (110) being rotatable relative to each other.
[3" id="c-fr-0003]
3. Machine according to claim 2, the plate (10) being rotatable about a vertical axis of rotation (Z).
[4" id="c-fr-0004]
4. Machine according to any one of the preceding claims, the gripping tool (110) being movable vertically and along at least one horizontal axis (Y).
[5" id="c-fr-0005]
5. Machine according to any one of the preceding claims, the gripping tool (110) comprising a pressing system (113) comprising a shoe (115) movable vertically opposite a support surface (112c).
[6" id="c-fr-0006]
6. Machine according to any one of the preceding claims, the gripping tool (110) having a surface (115b) onto which opens at least one orifice (118b) selectively connected to a source of vacuum, in particular a depression created by effect Venturi.
[7" id="c-fr-0007]
7. Machine according to claims 5 and 6, the orifice (118b) opening onto the underside of the shoe (115).
[8" id="c-fr-0008]
8. Machine according to any one of the preceding claims, the gripping tool (110) comprising a member (114) for pushing the sterilization packaging material (F) under the object (B).
[9" id="c-fr-0009]
9. Machine according to claim 8, said member (114) being in the form of a horizontal plate mounted at the lower end of the gripping tool (110), this plate (114) preferably thinning in direction of its distal edge.
[10" id="c-fr-0010]
10. Machine according to any one of the preceding claims, the plate (10) comprising at least one finger (15) movable vertically, for lifting the object (B) and the sterilization packaging material (F) locally.
[11" id="c-fr-0011]
11. Machine according to any one of the preceding claims, comprising a table (11) extending around the plate (10), with at least one truncated corner (12).
[12" id="c-fr-0012]
12. Machine according to any 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 be move relative to each other, the holding and / or folding tool (20) being arranged to intervene on the sterilization packaging material (F) when at least one fold has been formed on along one side (Ml) of the object, by pressing with the aid of at least one plating member (28) the sterilization packaging material (F) on at least one adjacent side (M3) of the object, near the side along which the fold was formed and around which the next fold should be made.
[13" id="c-fr-0013]
13. Machine according to claim 12, the holding and / or folding tool (20) comprising a pushing member (29), movable inwardly for pushing inward a portion (F7) of the material. sterilization package (F) extending along the fold already formed, facing the portion (F6) of the sterilization package material (F) already pressed against the object (B).
[14" id="c-fr-0014]
14. Machine according to claims 12 and 13, the plating member (28) being in the form of a vertical fixed plate, and the pushing member (29) in the form of a vertical plate, movable around a horizontal axis of rotation (K), preferably between a raised position and a lowered position where it overlaps at least partially with the fixed plate.
[15" id="c-fr-0015]
15. Machine according to any one of the preceding claims, comprising at least two clamps (50) making it possible to grasp at least a portion (F5) of the packaging between them and to lift it or them, so as to allow a corner of the sterilization packaging material (F) under the portion (s) (F5) thus raised.
[16" id="c-fr-0016]
16. Machine according to claim 15, the two clamps (50) being mounted so as to be able to move away from one another and to stretch the portion (s) (F5) seized.
[17" id="c-fr-0017]
17. Machine according to claims 15 and 16, the clamps being pivotally mounted on the holding and / or folding tool (20).
[18" id="c-fr-0018]
18. Machine according to any one of the preceding claims, comprising an object holding system comprising at least two movable holding members (70), between which the object (B) can be held laterally.
[19" id="c-fr-0019]
19. Machine according to claim 18, the holding members (70) being formed by two pivoting flaps (70), mounted on the folding and / or holding tool (20).
[20" id="c-fr-0020]
20. Machine according to any one of claims 15 to 19, the holding and / or folding tool (20) comprising two lateral parts (22) each comprising a U-shaped frame, with a front profile (26b) carrier of one of the thrust members (29) and a rear section (26c) carrier of one of the clamps (50).
[21" id="c-fr-0021]
21. Machine according to claim 20, each side part comprising an intermediate section (26f), each of the flaps (70) being articulated between this intermediate section (26f) and the rear section (26c).
[22" id="c-fr-0022]
22. Machine according to any one of the preceding claims, comprising a system for verifying the conformity of the composition of the content of the object (B) before and / or after packaging, in particular by laser analysis or by weighing the object (B).
[23" id="c-fr-0023]
23. Machine according to any one of the preceding claims, comprising a system for labeling and / or marking the object (B), in particular by laser printing or ink jet, before and / or after packaging, in particular allowing its traceability.
[24" id="c-fr-0024]
24. Machine according to any one of the preceding claims, comprising a system for validating the closure of the sterilization packaging enveloping the object (B), and in particular a system for validating the closure of a surgical pack.
[25" id="c-fr-0025]
25. Machine according to any one of the preceding claims, comprising a system for recording, storing and managing data allowing the traceability of the operations carried out by the machine (1).
[26" id="c-fr-0026]
26. Machine according to any one of the preceding claims, comprising at least one reel (304) for unwinding a reel (305) of sterilization packaging material (F) and a cutting device (301) of this material sterilization packaging (F).
[27" id="c-fr-0027]
27. Machine according to any one of the preceding claims, comprising a system for closing the packaging with at least one adhesive tape containing or not containing at least one sterilization indicator.
[28" id="c-fr-0028]
28. Machine according to any one of the preceding claims, comprising at least one reel for unwinding a roll of adhesive tape or not containing at least one sterilization indicator and a device for cutting this tape to close the packaging.
[29" id="c-fr-0029]
29. Assembly comprising a machine according to 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).
[30" id="c-fr-0030]
30. Method of packaging with at least one sterilization packaging material (F), in particular an object sterilization sheet, preferably a sterilization basket (B), the packaging being carried out using a machine (1) according to any one of claims 1 to 28, in which at least four plies are formed by successively gripping a corner of the sterilization packaging material (F) using the gripping tool (110) and by moving the sterilization packaging material (F) by this corner above the object (B).
[31" id="c-fr-0031]
31. The method of claim 30, wherein between two plies is rotated the sterilization packaging material (F) with the object (B) above relative to the gripping tool (110), preferably by performing a rotation with the plate (10), in particular by 90 °.
[32" id="c-fr-0032]
32. Method according to one of claims 30 and 31, wherein after the formation of the first fold is pushed the first corner (Fl) having been gripped to make this first fold, under the object (B).
[33" id="c-fr-0033]
33. Method according to any one of claims 30 to 32, in which the sterilization packaging material (F) is held against the object (B) and a previously formed fold is pushed back laterally inwards.
[34" id="c-fr-0034]
34. The packaging method according to any one of claims 30 to 33, the packaging being carried out with two sterilization packaging materials (F), in particular sequentially.
[35" id="c-fr-0035]
35. The packaging method according to any one of claims 30 to 33,
5 the packaging being produced with two sterilization packaging materials (F), these two sterilization packaging materials (F) being joined together at one or more binding sites and the packaging being produced simultaneously with the two sterilization packaging materials (F).
1/35
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同族专利:
公开号 | 公开日
EP3728048A1|2020-10-28|
US20200391890A1|2020-12-17|
EP3728048B1|2022-02-09|
CA3084884A1|2019-06-27|
FR3075181B1|2020-01-10|
WO2019121571A1|2019-06-27|
引用文献:
公开号 | 申请日 | 公开日 | 申请人 | 专利标题
GB953551A|1959-10-01|1964-03-25|Hedwig Gamble|Wrapping device|
US5502954A|1993-07-21|1996-04-02|Tokyo Automatic Machinery Works, Ltd.|Flap folding device of wrapping machine|
EP1281617A1|2001-08-02|2003-02-05|Coppens Verpakkings-systemen B.V.|Method and device for packing a product, such as one or more slices of a cheese or meat product, in film material|
EP1717149A1|2005-04-21|2006-11-02|Atlanta Stretch s.p.a.|Apparatus for placing a covering sheet over the top of palletized loads during wrapping with stretch film|CN111361777A|2020-03-26|2020-07-03|广东智源机器人科技有限公司|Packaging method|CA2111071E|1993-06-30|2011-08-23|Sonya Nicholson Bourne|Single step sterilization wrap system|CN111821040A|2020-05-28|2020-10-27|皇润佳医疗科技南京有限责任公司|Surgical knife auxiliary robot and auxiliary method thereof|
CN111591486A|2020-05-31|2020-08-28|黄静|Plastic packaging device|
法律状态:
2018-10-30| PLFP| Fee payment|Year of fee payment: 2 |
2019-06-21| PLSC| Publication of the preliminary search report|Effective date: 20190621 |
2019-10-30| PLFP| Fee payment|Year of fee payment: 3 |
2021-01-29| PLFP| Fee payment|Year of fee payment: 5 |
2021-10-28| PLFP| Fee payment|Year of fee payment: 5 |
优先权:
申请号 | 申请日 | 专利标题
FR1762381A|FR3075181B1|2017-12-18|2017-12-18|MACHINE FOR PACKAGING WITH AT LEAST ONE STERILIZATION PACKAGING MATERIAL|
FR1762381|2017-12-18|FR1762381A| FR3075181B1|2017-12-18|2017-12-18|MACHINE FOR PACKAGING WITH AT LEAST ONE STERILIZATION PACKAGING MATERIAL|
PCT/EP2018/085319| WO2019121571A1|2017-12-18|2018-12-17|Machine and method for packaging by at least one sterilisation packaging material|
CA3084884A| CA3084884A1|2017-12-18|2018-12-17|Machine for packaging with at least one sterilization packaging material|
US16/955,017| US20200391890A1|2017-12-18|2018-12-17|Machine for packaging with at least one sterilization packaging material|
EP18816096.4A| EP3728048B1|2017-12-18|2018-12-17|Machine and method for packaging by at least one sterilisation packaging material|
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