Packaging for a medical endoscope

Description

Technical Field

[0001] The invention relates to packaging for a medical endoscope, which is reusable or single-use.

[0002] Medical endoscopes allow access to the internal surface of a hollow organ, cavity, or natural or artificial duct in the human body for various therapeutic, surgical, or diagnostic purposes. Medical endoscopes are used to inspect all internal parts of the human body accessible through natural or artificial orifices. For example, medical endoscopes can be used to examine the urinary tract, gastrointestinal tract, respiratory system, cardiovascular system, trachea, sinus cavity, female reproductive system, abdominal cavity, or any other part of the human body that can be explored through a natural or artificial orifice.

[0003] Given their use, it is essential that medical endoscopes be stored in sterile packaging, which constitutes a sterile barrier and protects them from possible damage that may result from shocks during transport in particular. Previous technique

[0004] A medical endoscope consists of a control handle, an insertion tube, and a power cord. It is typically packaged in a tray or box covered with plastic film. The tray usually includes a compartment for the endoscope, one section of which holds the control handle. This handle is located in line with a second section that holds the insertion tube, and possibly a third section for the power cord. The tray is covered with a plastic film that provides sterilization and creates a sterile barrier. Generally, the film is tightly sealed around the edge of the tray to ensure the sterility of the endoscope.

[0005] Typically, the housing includes a rib in the shape of a circular arc to receive the insertion tube, as seen in US patents 5,947,284 and EP 3,148,396, among others. However, the insertion tube can become deformed and damaged when stored in this position, and it is preferable to use packaging in which the tube is held in a straight position, aligned with the control handle.

[0006] To secure the medical endoscope in its packaging, the packaging may include clips, for example. However, inserting or removing the medical endoscope from its housing can be difficult, and when the clips are located near the insertion tube, the tube can be damaged during these insertion and removal operations. To address this problem, various solutions have been considered. For example, US patent 5,947,284 proposes inserting the medical endoscope's insertion tube into a curved tube that then serves as a guide for removing the tube. However, this solution has the disadvantage of creating significant vibration and stress, particularly during transport. Furthermore, this solution can be difficult for the practitioner to implement, not only when removing the medical endoscope from its packaging but also when setting it down for use.Furthermore, this solution is not economical since it requires the preparation of a tube adapted for packaging. Finally, the insertion tube is stored in a semicircular position, which presents the risks mentioned above.

[0007] This same US patent 5,947,284 proposes another solution for securing the medical endoscope in its packaging: the use of a second film to cover the portion of the housing containing the insertion tube. To achieve this, attachment points for this second film are arranged around the perimeter of the tray, near the peripheral edge. This solution has the disadvantage of not sufficiently securing the insertion tube in the packaging. Furthermore, this solution can be difficult for the practitioner to implement due to the two films that must be removed to take the endoscope out of its packaging. Again, the insertion tube is placed in a semicircular housing, which presents the aforementioned drawbacks. In addition, document EP 0 647 425 discloses an endoscopic sheath designed to protect and / or modify the viewing angle of an endoscope.The sheath includes a distal portion designed to fit the most distal part of the endoscope's imaging optics. This distal portion incorporates a structure for changing the endoscope's viewing angle. US patent 4,262,800 discloses a sterilizable holder for a fiber optic surgical unit or similar delicate medical instrument. This holder includes a base, an instrument contour formed on the base, pairs of retaining pins arranged around the contour on the base, and elastic bands attached to the pins to secure the instrument to the holder. GB patent 2,497,353 discloses a storage device designed to support an endoscope comprising a first flexible tube for insertion into the body, a second flexible transmission tube, and an interface housing connecting the first and second flexible tubes.The storage tray is designed to hold the endoscope in a coiled configuration, such that at least one of the two tubes overlaps the interface housing. US patent 2020 / 214820 discloses a packaging system for use with a ureteral stent having an elongated body extending from a proximal to a distal end, and which may include a tray base. The tray base may include at least a first stud, a second stud, and a projection or groove designed to secure the distal end, proximal end, and a tether of the ureteral stent to the tray base, respectively. EP patent 2,335,636 discloses a sterilizable package comprising a support element and a foil material forming either a cover for the support element or a pouch in which the support element is disposed.The sheet material comprises a barrier material and includes a breathable membrane made of a material permeable to moisture and gases, but impermeable to microorganisms. The breathable membrane allows the introduction of a sterilizing gas into the sterilizable packaging. It is positioned towards a central portion of the sheet material and is spaced away from any welds connecting the sheet material to the support element or from any welds defining the pouch.

[0008] Therefore, there is a need for medical endoscope packaging that is sterilizable and robust enough to provide a sterile barrier until use. There is also a need for user-friendly packaging: it should be easy to open, ideally allowing the practitioner to easily remove the endoscope during use for later reuse. Furthermore, the packaging should securely hold the endoscope in place: the control handle and insertion tube should be properly secured in their compartments to prevent damage during storage or transport. Finally, the packaging should keep the insertion tube straight and aligned with the control handle. Description of the invention

[0009] The invention aims to overcome the drawbacks of the art of the art by proposing packaging for a medical endoscope comprising a control handle and an insertion tube, said packaging comprising: a tray having an inner face having a peripheral area, said tray having on its inner face a housing receiving the medical endoscope, the housing including a cavity receiving the control handle, and a straight groove receiving the insertion tube, the groove having a cross-section greater than the cross-section of the insertion tube to allow its free insertion, a sheet permeable to gases and to beta and gamma radiation, impermeable to microbes, sealed continuously and hermetically to the peripheral area of ​​the inner face of the tray by a pull-out force, characterized in that the tray includes protuberances extending in projection from its inner face and arranged on either side of the groove, and in that the sheet is fixed to the protuberances by a pull-out force less than at least 30% compared to the pull-out force between the sheet and the peripheral area.

[0010] Within the framework of the invention, the pull-out force between the sheet and the peripheral area (or protrusions) corresponds to the force required per unit area to pull the sheet from the peripheral area (or protrusions). The pull-out force can be measured in N / mm².

[0011] Within the framework of the invention, a "removal force between the sheet and the protrusions lower than at least 30% compared to the removal force between the sheet and the peripheral area" means that the ratio between the removal force between the sheet and the protrusions and the removal force between the sheet and the peripheral area at isosurface (i.e. for the same contact area between the sheet and the protrusions on the one hand, and between the sheet and the peripheral area on the other hand) is less than or equal to 0.7.

[0012] The packaging according to the invention allows the insertion tube to be kept in a straight position and in line with the control handle, thus ensuring better preservation of the insertion tube.

[0013] The packaging according to the invention makes it possible to ensure a sterile barrier for the medical endoscope, thanks to the continuous and airtight seal between the tray and the sheet which is impermeable to microbes.

[0014] The presence of protrusions on either side of the groove allows the insertion tube to be held in position in the packaging, without deformation or crushing.

[0015] The packaging according to the invention is easy to use, both for placing the endoscope inside its packaging and for opening the packaging by the practitioner. Opening is quick and easy. According to an advantageous embodiment of the invention, the practitioner can place the medical endoscope back in its packaging during the procedure if necessary, and then use it again for the same patient and during the same procedure, for example.

[0016] The packaging according to the invention advantageously has one or more of the following characteristics: The protrusions are positioned at the edge of the throat; the protrusions are distributed along the throat; the protrusions are arranged alternately on one side or the other of the throat; the housing includes a groove for receiving a power cable for the medical endoscope; at least one protrusion is positioned at the edge of the groove; at least one protrusion is present in the groove to wind the power cable; the protrusions are studs or ribs; the packaging includes two stop lines provided in the portions of the peripheral area located on either side of the throat; the housing includes clips to hold the control handle in position; the housing includes a recess for receiving a connector for the power cable of the medical endoscope; the packaging includes a hanging slot in the peripheral area;The packaging also includes an adhesive surface on the inner face of the tray which is covered with a peelable film.

[0017] The invention also relates to a method for packaging a medical endoscope comprising the following steps: a) to have a medical endoscope comprising a control handle, an insertion tube, and optionally a power cable; b) to have a tray having an inner face with a peripheral area, said tray having on its inner face a housing for receiving a medical endoscope, the housing being composed of a cavity for receiving the control handle, a straight groove for receiving the insertion tube, and optionally a channel for receiving the power cable, the groove having a cross-section larger than that of the insertion tube to allow its free insertion; said tray comprising protrusions extending outward from its inner face and arranged on either side of the groove; c) to have a sheet permeable to gases and beta and gamma radiation, impermeable to microbes, and heat-sealable; d) to place the medical endoscope in the housing.(e) bring the heat-sealable sheet into contact with the peripheral area and with the protrusions, heat to a sealing temperature, apply peripheral sealing pressure to the peripheral area allowing an airtight seal of the sheet to the peripheral area to obtain a pull-out force, and apply central sealing pressure to the protrusions allowing the sheet to be fixed to the protrusions to obtain a pull-out force, the peripheral sealing pressure and the central sealing pressure being such that the pull-out force between the sheet and the protrusions is at least 30% less than the pull-out force between the sheet and the peripheral area.

[0018] Advantageously, step b) of the method according to the invention is such that either the peripheral area and the protrusions extend in projection to the same height relative to the internal surface of the tray, or the protrusions are in projection to a height less than that of the peripheral area relative to the internal surface of the tray. Brief description of the drawings

[0019] [ Fig. 1 ] There figure 1 is a top view showing a tray of packaging for receiving an endoscope according to a first embodiment of the invention in which the protrusions are in the form of studs. Fig. 2 ] There figure 2 is a top view showing a medical endoscope in packaging according to a first embodiment of the invention in which the protrusions are in the form of studs. Fig. 3 ] There figure 3 is a cross-sectional view along line BB of the figure 2 showing the insertion tube of a medical endoscope in the throat of a package according to the invention. Fig. 4 ] There figure 4 represents a detailed top view showing packaging conforming to a second embodiment of the invention in which the protrusions are in the form of ribs and studs. Fig. 5 ] There figure 5 is a top view showing a medical endoscope in packaging according to the second embodiment of the invention, in which the protrusions are in the form of studs and ribs. Fig. 6 ] There figure 6 is a cross-sectional view taken along lines AA of the figure 5 . [ Fig. 7 ] There figure 7 is a cross-sectional view taken along lines II of the figure 5 . [ Fig. 8 ] There figure 8 is a top view showing a medical endoscope in packaging, which also includes a recess for the cable connector. Fig. 9 ] There figure 9 is a top view showing a medical endoscope in packaging, including an adhesive surface for resealing the packaging after opening. Description of the implementation methods

[0020] As shown in the figures, the invention relates to a packaging 1 for a medical endoscope 2, conventionally composed of a control handle 3, an insertion tube 4 and optionally a power cable 5. The packaging 1 according to the invention comprises a tray 6 designed to receive the medical endoscope 2 and closed by a sheet 7 assembled with the tray 6.

[0021] As depicted in the figure 1 The plate 6 is provided with an inner face 6i having a peripheral area 6p. According to a first embodiment illustrated in figures 2 et 3 The peripheral area 6p does not extend beyond the inner face 6i of the plate 6 but is flush with the inner face 6i, meaning that the peripheral area 6p and the inner face 6i of the plate 6 lie in the same plane. Alternatively, according to the embodiment illustrated in figures 5 à 7 , the peripheral range 6p extends in projection from the inner face 6i of the plate 6, thus forming a peripheral rim.

[0022] The tray 6 has a housing 8 on its inner face 6 i to receive the medical endoscope 2, as illustrated in the figure 1 This housing 8 consists of a cavity 9 opening into a straight groove 10, as well as into a channel 11. Although not illustrated, the housing 8 may not have a channel 11 in the case where the medical endoscope 2 does not have a power cable 5.

[0023] The cavity 9 is intended to receive the control handle 3. Its dimensions allow the control handle 3 to be fully inserted so that it does not protrude from the inner face 6 i of the plate 6. According to a particular embodiment of the invention, the cavity 9 includes at least one clip to hold the control handle 3 in position.

[0024] The gutter 11 is intended to receive the power cable 5. The dimensions and shape of the gutter 11 are such that the entire power cable 5 can be inserted into it, so that it does not protrude from the internal surface 6 i of the tray 6.

[0025] According to an embodiment illustrated in the figure 8 The power cable 5 has a connector 5c at its free end. According to this embodiment, the housing 8 further includes a recess 11a for receiving the connector 5c. More precisely, the channel 11 opens into the recess 11a. The recess 11a may include at least one clip to hold the connector 5c in position. According to this embodiment, the connector 5c does not protrude from the internal surface 6i of the tray 6.

[0026] The groove 10 is designed to receive the insertion tube 4 of the medical endoscope 2. The groove 10 therefore has a larger cross-section than the insertion tube 2 to allow for its free insertion. Advantageously, the cross-section of the groove 10 is larger than the cross-section of the insertion tube, with sufficient clearance to allow the insertion tube 4 to engage freely without jamming in the groove 10. Thus, the insertion tube 4 is held laterally by the walls of the groove 10 while still allowing for insertion and removal without obstruction. This avoids the risk of damage to the insertion tube 4 during assembly and removal. The groove 10 is straight along a longitudinal axis L, so that the insertion tube 4 is also straight when placed in the packaging 1. Preferably, the groove 10 is tubular in shape. The groove 10 opens onto the inner face 6i by its edge 10b, as illustrated in the figure 3 .

[0027] Plateau 6 also includes at least two protuberances having a top face 12s and extending outward from the inner face 6i of plateau 6.

[0028] In the context of the invention, the plate 6 includes at least two protrusions 12a arranged on either side of the groove 10, that is to say on each side of the groove 10. In other words, these protrusions 12a extend in projection from the inner face 6i of the plate 6, between the peripheral area 6p and the housing 8. Preferably, these protrusions 12a are positioned at the edge of the groove 10, that is to say that the protrusions 12a are joined to the edge 10b of the groove. Advantageously, the protrusions 12a are contiguous with the groove 10, and in particular the distance between each protrusion 12a and the edge 10b of the groove 10 is less than the diameter of the insertion tube 4, which prevents the insertion tube 4 from coming out of the groove 10. These protrusions 12a are advantageously distributed from one end to the other of the groove 10, although this is not obligatory and they could be arranged along a part of the groove 10.Preferably, the protrusions 12a are arranged alternately on one side or the other of the groove 10. Although not preferred, it could be envisaged that the protrusions 12a be arranged opposite each other on either side of the groove 10. Preferably, the protrusions 12a are distributed at regular intervals along the groove 10. According to one embodiment, the protrusions 12a are aligned along two axes parallel to the longitudinal axis L of the groove 10, these two axes being at an equal or unequal distance from the longitudinal axis L of the groove 10.

[0029] According to a particular embodiment of the invention illustrated in figure 2 In particular, the platform 6 further includes at least one protrusion 12b positioned at the edge of the gutter 11 in order to hold the power cable 5 in position within it. These protrusions 12b may be located on either side of the gutter 11. Alternatively, as shown in figures 1 et 2 In particular, the gutter 11 is arranged to pass through at least one protrusion 12b so that at least one protrusion 12b extends on both sides of the gutter 11. Thus, the same protrusion 12b can be positioned to be at the edge of both the groove 10 and the gutter 11.

[0030] According to a particular embodiment of the invention illustrated in figure 5 In particular, the plate 6 further includes one or more protrusions 12c positioned in the gutter 11 in order to hold the power cable 5 in position in the gutter 11. Thus according to this embodiment, the power cable 5 is wound around the protrusions 12c which are mounted in the gutter 11.

[0031] According to a first embodiment, the protuberances 12a, 12b, 12c can be discrete elements, and are then presented in the form of studs or columns, as shown in figures 1 à 3 In particular, advantageously, the various studs bordering the groove 10 and / or the gutter 11 are of identical dimensions, although a slight variation is possible. According to this embodiment, the protrusions 12c mounted in the gutter 11 may advantageously be of different dimensions from the protrusions 12a bordering the groove 10 and the protrusions 12b bordering the gutter 11, although this is not mandatory.

[0032] According to a second embodiment, the protuberances 12a, 12b, 12c are in the form of ribs, preferably straight and parallel to the longitudinal axis L of the groove 10, as shown in figures 4 et 5 The dimensions of the ribs may be different or, preferably, equal. According to this embodiment, the groove 10 and / or the gutter 11 may be bordered by two ribs running from one end to the other, i.e., each of the two ribs has a length identical to the edge 10b of the groove 10 and / or the edge of the gutter 11. Alternatively, the groove 10 and / or the gutter 11 may be bordered by at least two ribs of shorter length than the length of the groove 10 and / or the gutter 11.

[0033] According to a third embodiment, some protrusions 12a, 12b, 12c are in the form of studs, and some protrusions 12a, 12b, 12c are in the form of ribs parallel to the longitudinal axis L. This embodiment is illustrated in particular in figures 5 And 8 .

[0034] The tray 6 can be made of any material which not only allows its attachment with the sheet 7, but also contributes to the sterility of the medical endoscope 2. The tray 6 is typically made of thermoplastic material, and for example chosen from polyethylene terephthalate (PET), amorphous polyethylene terephthalate (APET), glycolized polyethylene terephthalate (PETg), polystyrene, and polyvinyl chloride (PVC).

[0035] The packaging 1 according to the invention further comprises a sheet or film 7 fixed to the peripheral area 6p of the tray 6 and on the protrusions 12a, 12b, 12c. This fixing can be achieved by heat sealing, for example.

[0036] The peripheral area 6p of the tray 6 and the sheet 7 are sealed. Thus, the connection between the tray 6 and the sheet 7 is continuous and airtight around the entire perimeter of the inner face 6i of the tray 6. According to the embodiment illustrated in the figure 3 The peripheral area 6p does not extend beyond the inner face 6i of the plate 6, and the sheet 7 is deformed towards the plate. According to the embodiment illustrated in figures 6 And 7 , the peripheral area 6p is salient relative to the inner face 6i of the plate 6 and the sheet 7 is flat.

[0037] The fixation between the sheet 7 and the peripheral area 6p of the tray 6 is defined by a pull-out force required to detach the sheet 7 from the peripheral area 6p of the tray 6. This pull-out force is such that the sheet can be removed from the tray without excessive effort by the practitioner, while still allowing for effective and sterile closure of the packaging 1. Typically, the pull-out force between the sheet 7 and the peripheral area 6p of the tray 6 ranges from 0.0015 N / mm² to 2 N / mm², preferably from 0.007 N / mm² to 0.03 N / mm². Within the scope of the invention, the pull-out force can be measured according to EN 868-5.

[0038] Next, sheet 7 is also attached to the plate 6 via the protrusions 12a, 12b, 12c. More precisely, sheet 7 is attached to the upper face 12s of the protrusions 12a, 12b, 12c, regardless of their shape. The attachment between sheet 7 and the protrusions 12a, 12b, 12c is defined by a pull-out force to detach sheet 7 from the protrusions 12a, 12b, 12c. The fixing of the sheet 7 on the protrusions 12a bordering the groove 10 allows the insertion tube 4 to be held inside the groove 10, and the fixing of the sheet 7 on the protrusions 12b bordering the gutter 11 allows the power cable 5 to be held inside the groove 11. Typically, the pull-out force between the sheet 7 and the protrusions 12a, 12b, 12c ranges from 0.001 N / mm² to 0.1 N / mm², preferably from 0.005 N / mm² to 0.02 N / mm².

[0039] Within the framework of the invention, the pull-out force between the sheet 7 and the protuberances 12a, 12b, 12c is less than the pull-out force between the sheet 7 and the peripheral area 6p of the tray 6. Thus, the opening of the package 1 by the practitioner is easy, while ensuring the sterility of the medical endoscope 2 which is inside the package 1 and its safe storage. More specifically, the pull-out force between the sheet 7 and the protrusions 12a, 12b, 12c is less than 30% compared to the pull-out force between the sheet and the peripheral area of ​​the plate, that is to say that the ratio between the pull-out force between the sheet 7 and the protrusions 12a, 12b, 12c and the pull-out force between the sheet 7 and the peripheral area 6p of the plate 6 at isosurface (that is to say for the same unit area) is less than or equal to 0.7.Furthermore, the number, shape, dimensions, and value of the pull-out force of the protrusions 12a, 12b, 12c can be chosen by a person skilled in the art according to the desired total pull-out forces and in such a way as to allow the insertion tube 4 to be held inside the groove 10 and the supply cable 5 to be held in the channel 11.

[0040] The film 7 is made of any material that allows it to be attached to the tray 6 and ensures the sterility of the medical endoscope 2 by forming a sterile barrier. Specifically, the film 7 must be permeable to beta and gamma radiation to allow the sterilization of the packaging 1 containing the medical endoscope 2. Furthermore, the film 7 must be impermeable to microbes to keep the medical endoscope 2 sterile within its packaging. For example, the film 7 can be made of plastic or a combination of paper and plastic. In a preferred embodiment, the film is made of a plastic material, particularly a thermoplastic, such as polyamide or polyethylene, like Tyvek®, marketed by DuPont de Nemours, for example.

[0041] According to a particular embodiment of the invention shown in the figure 5 The packaging 1 further includes two stop lines 13 arranged in the peripheral area 6p. These stop lines 13 are located on either side of the groove 10, and preferably lie on the same axis perpendicular to the longitudinal axis L of the groove 10. Thus, these stop lines pass through both sides of the peripheral area 6p located on either side of the groove 10. Therefore, when the practitioner opens the packaging 1, this opening (consisting of detaching the sheet 7 from the tray 6) can be made up to these two stop lines 13. The opening must then be large enough to allow the medical endoscope 2 to be easily removed from its packaging 1. Advantageously, the medical endoscope can be easily replaced in the packaging 1 by the practitioner, if necessary.

[0042] According to a particular embodiment, the packaging 1 further comprises an adhesive surface 14 on the inner face 6i of the tray 6, preferably opposite the peripheral area 6p as illustrated in the figure 9 , and / or partially covering the peripheral area 6p. The adhesive surface 14 may be continuous or discontinuous. Preferably, the adhesive surface 14 is in the form of a contour extending from one stop line 13 to the other, in the part of the inner face 6i of the tray 6 intended to be opened, i.e., on the side of the cavity 9. Alternatively, as illustrated in the figure 9This adhesive surface 14 is located around the entire perimeter of the packaging, that is, along the entire length of the peripheral area 6p. The adhesive surface 14 is either contiguous with the peripheral area 6p, or close to the peripheral area 6p, and, in any embodiment, may partially cover the peripheral area 6p. The adhesive surface 14 is preferably positioned at the edge of the cavity 9. Advantageously, the adhesive surface 14 is positioned between the peripheral area 6p and the recess 8. According to this embodiment, the adhesive surface 14 is covered with a peelable film. Thus, according to this embodiment, the practitioner can open the package 1 in its entirety or up to the two stop lines 13, use the medical endoscope 2 as needed, replace it in the package, remove the peelable film and close the package 1 by bringing the adhesive surface 14 into contact with the sheet 7.Depending on the practitioner's needs, the packaging can be opened or resealed.

[0043] According to a particular embodiment, the packaging 1 according to the invention includes a hanging slot 15 in the peripheral area 6p, so as to allow the packaging 1 to be suspended. Preferably, this slot 15 is oblong. Preferably, this slot 15 is located in the part of the peripheral area 6p opposite the cavity 9 intended to receive the control handle 3.

[0044] The invention also relates to a method for packaging a medical endoscope 2 comprising the following steps: a) to have a medical endoscope 2 comprising a control handle 3, an insertion tube 4, and optionally a power cable 5, b) to have a tray 6 having an inner face 6i having a peripheral area 6p, said tray 6 having on its inner face 6i a housing 8 for receiving a medical endoscope 2, the housing 8 being composed of a cavity 9 for receiving the control handle 3, a straight groove 10 for receiving the insertion tube 4, and optionally a channel 11 for receiving the power cable 5, the groove 10 having a cross-section larger than the cross-section of the insertion tube 4 to allow its free insertion, said tray 6 comprising protrusions 12a extending outward from its inner face 6i and arranged on either side of the groove 10, c) to have a waterproof and heat-sealable sheet 7, d) Place the medical endoscope 2 in slot 8,e) bring the heat-sealable sheet 7 into contact with the peripheral area 6p and with the protrusions 12a, heat to a sealing temperature, apply a peripheral sealing pressure on the peripheral area 6p allowing a hermetic seal of the sheet 7 on the peripheral area 6p to obtain a pull-out force, and apply a central sealing pressure on the protrusions 12a allowing the sheet 7 to be fixed to the protrusions 12a to obtain a pull-out force, the peripheral sealing pressure and the central sealing pressure being such that the pull-out force between the sheet 7 and the protrusions 12a is at least 30% less than the pull-out force between the sheet 7 and the peripheral area 6p.

[0045] In step b), tray 6 is as described above for packaging 1 according to the invention.

[0046] In step c), sheet 7 is as described above for packaging 1 according to the invention.

[0047] In step e), heating can be achieved by conduction, IR radiation, laser beam, or ultrasound using a sonotrode, for example. The sealing temperature is defined as the temperature at which heat sealing occurs between tray 6 and sheet 7. This temperature depends on the materials used to manufacture tray 6 and sheet 7 and can be determined by a person skilled in the art.

[0048] In step e), pressure is applied using a sonotrode for example.

[0049] In step e), a peripheral sealing pressure is applied to the sheet 7 and the peripheral area 6p of the tray 6, preferably concomitantly with heating, which allows a hermetic seal around the entire perimeter of the package 1, between the sheet 7 and the peripheral area 6p of the tray 6. This heating combined with the application of the peripheral pressure allows heat sealing between the peripheral area 6p of the tray 6 and the sheet 7.

[0050] As described above, the tray 6 may include at least one protrusion 12b bordering the gutter 11 and / or at least one protrusion 12c provided in the gutter 11. According to this embodiment, the central sealing pressure is also applied to the protrusions 12b bordering the gutter 11 and / or the protrusions 12c provided in the gutter 11, to allow the fixing of the sheet 7 on all the protrusions 12a, 12b, 12c and obtain a pull-out force. According to this embodiment, the peripheral sealing pressure and the central sealing pressure are such that the pull-out force between the sheet 7 and the protrusions 12a, 12b, 12c is at least 30% lower than the pull-out force between the sheet 7 and the peripheral range 6p.

[0051] At step e), a central sealing pressure is applied to the sheet 7 and the protrusions 12a, 12b, 12c extending outward from the plate 6, preferably concomitantly with heating, which allows the sheet 7 to be fixed to the upper face 12s of the protrusions 12. Thus, the sheet 7 is fixed to the protrusions 12a, 12b, 12c, and more precisely to the upper face 12s of the protrusions 12a, 12b, 12c.

[0052] In the context of the invention, the pull-out force between the sheet 7 and the peripheral area 6p of the plate 6 is greater than the pull-out force between the sheet 7 and the protrusions 12a, 12b, 12c, by at least 30%. To achieve this, the central sealing pressure is lower than the peripheral sealing pressure. According to a first embodiment, in step b), the peripheral area 6p and the protrusions 12a, 12b, 12c extend to the same height relative to the internal surface 6i of the plate 6. According to this embodiment, the pressure applied in step e) at the level of the peripheral area 6p is then higher than the pressure applied at the level of the protrusions 12a, 12b, 12c. According to a second embodiment, in step b), the protuberances 12a, 12b, 12c are projecting at a height less than that of the peripheral area 6p relative to the internal surface 6i of the platform 6.According to this embodiment, in step e), the pressure applied at the level of the peripheral range 6p can be identical to that applied at the level of the protrusions 12a, 12b, 12c.

Claims

1. A packaging (1) for a medical endoscope (2) including an operating handle (3) and an insertion tube (4), said packaging (1) comprising: - a tray (6) with an inner face (6i) having a peripheral region (6p), said tray (6) including, on its inner face (6i), a housing (8) that receives the medical endoscope (2), the housing (8) comprising a cavity (9) that receives the operating handle (3), and a straight groove (10) that receives the insertion tube (4), the groove (10) having a cross-section greater than that of the insertion tube (4) to allow for its free insertion, - a sheet (7) that is permeable to gases and to beta and gamma radiation, impermeable to microbes, and continuously and hermetically sealed to the peripheral region (6p) of the inner face (6i) of the tray (6) with a specified peel load, characterized in that the tray (6) comprises protrusions (12a) extending outward from its inner face (6i) and arranged on either side of the groove (10), in that the sheet (7) is secured to the protrusions (12a) with a specified peel load, and in that the ratio of the peel load between the sheet (7) and the protrusions to the peel load between the sheet (7) and the isosurface peripheral region (6p) is less than or equal to 0.7.

2. The packaging (1) according to claim 1, wherein the protrusions (12a) are positioned at the edge of the groove (10).

3. The packaging (1) according to any of the preceding claims, wherein the protrusions (12a) are distributed along the groove (10).

4. The packaging (1) according to any of the preceding claims, wherein the protrusions (12a) are arranged alternately on one side or the other of the groove (10).

5. The packaging (1) according to any of the preceding claims, wherein the housing (8) comprises a channel (11) that receives a power cable (5) of the medical endoscope (2).

6. The packaging (1) according to the preceding claim, wherein at least one protrusion (12b) is positioned at the edge of the channel (11).

7. The packaging according to claim 5 or 6, wherein at least one protrusion (12c) is present in the channel (11) in order to wind the power cable (5).

8. The packaging (1) according to any of the preceding claims, wherein the protrusions (12a, 12b, 12c) are studs or ribs.

9. The packaging (1) according to any of the preceding claims, comprising two stop lines formed in the portions of the peripheral region (6p) located on either side of the groove (10).

10. The packaging (1) according to any of the preceding claims, wherein the housing (8) includes clips for holding the operating handle (3) in place.

11. The packaging (1) according to any of the preceding claims, wherein the housing (8) comprises a recess (11a) that receives a connector (5c) of the power cable (5) of the medical endoscope (2).

12. The packaging (1) according to any of the preceding claims, comprising a hooking slot (15) in the peripheral region (6p).

13. The packaging according to any of the preceding claims, further comprising an adhesive surface (14) on the inner face (6i) of the tray (6), covered with a peelable film.

14. A method for packaging a medical endoscope (2) comprising the following steps: a) having a medical endoscope (2) including an operating handle (3), an insertion tube (4), and, optionally, a power cable (5), b) having a tray (6) with an inner face (6i) having a peripheral region (6p), said tray (6) including, on its inner face (6p), a housing (8) designed to receive a medical endoscope (2), the housing (8) consisting of a cavity (9) designed to receive the operating handle (3), a straight groove (10) designed to receive the insertion tube (4), and optionally a channel (11) designed to receive the power cable (5), the groove (10) having a cross-section greater than that of the insertion tube (4) to allow for its free insertion, said tray (6) comprising protrusions (12a) extending outward from its inner face (6i) and arranged on either side of the groove (10), c) having a sheet (7) that is permeable to gases and to beta and gamma radiation, impermeable to microbes, and heat-sealable, d) placing the medical endoscope (2) in the housing (8), e) bringing the heat-sealable sheet (7) into contact with the peripheral region (6p) and with the protrusions (12a), heating to a sealing temperature, applying a peripheral sealing pressure to the peripheral region (6p) to hermetically seal the sheet (7) to the peripheral region (6p) to obtain a peel load, and applying a central sealing pressure to the protrusions (12a) to secure the sheet (7) to the protrusions (12a) to obtain a peel load, the peripheral sealing pressure and the central sealing pressure being such that the peel load between the sheet (7) and the protrusions (12a) is at least 30% lower than the peel load between the sheet (7) and the peripheral region (6p).

15. The method according to the preceding claim, wherein, in step b), the peripheral region (6p) and the protrusions (12a) extend outward by the same height relative to the inner surface (6i) of the tray.

16. The method according to claim 14, wherein, in step b), the protrusions (12a) project to a height less than that of the peripheral region (6p) relative to the inner surface (6i) of the tray.