Packaging for medical devices

Abstract

Sterilizable packaging (1) for a medical device (20), comprising a pouch (2) for housing the device (20) to be packaged, said pouch (2) being insertable into a resealable case (10) comprising a lower container (11), said container being arranged with a base (18) and a side wall extending around the entire perimeter of the container (11) and an outer rim (13) forming a support for attaching a closure cap (15) permeable to at least one sterilizing agent. FIGURE 1

Description

Title of the invention: Packaging for a medical device

[0001] technical field

[0002] The present invention relates to a sterilizable packaging for a medical device, comprising an envelope that can be positioned in a case that can be resealed using a lid. Previous technique

[0003] Many types of packaging are known to package and protect fragile medical devices from direct contact with pathogens and to protect them from possible shocks that could cause damage.

[0004] In addition, several types of packaging are known that allow various forms of sterilization of a packaged product.

[0005] For example, document EP2944583 describes a medical device package with membrane closure allowing sterilization of the packaged device.

[0006] Document FR2816926 also describes packaging for sterilization. It comprises a plastic box and a lid fixed to the box so as to seal the latter by means of a hermetic sealing zone. The lid comprises a plastic cover sheet, transparent to electron beam irradiation and to light radiation, at least one window formed in the cover sheet, at least one sheet of a selectively airtight material, integral with the cover sheet and blocking the window, and an opaque screen for at least one electron beam passing through the cover sheet or the selectively airtight material, said screen extending inside the packaging, in the vicinity of the cover sheet so as to allow the penetration of a sterilizing gas, for example ethylene oxide or water vapor, through the selectively airtight material.

[0007] US2020268920 describes a sterile container comprising a container, a container lid, a closure device for closing the sterile container, and a sealing element between the container and the container lid. The sealing element is vapor-permeable.

[0008] Other medical packaging provides means of protection against shocks, commonly used in the field of packaging.

[0009] Document CN219116099 describes a medical device package comprising an absorbent piece intended to cushion shocks and protect the packaged object.

[0010] Document EP4000585 describes packaging for a medical device comprising a container having an opening, a medical device housed inside the container, and a gas-permeable sealing film applied by heat sealing. The inside of the container is adjusted to a negative pressure relative to atmospheric pressure so that the medical device is compressed by the gas-permeable film.

[0011] However, no packaging allows both sterilization capabilities for the packaged product and a satisfactory level of protection against shocks and vibrations that could damage the packaged object.

[0012] There is therefore a need for more efficient packaging that provides more complete protection for expensive and fragile medical devices.

[0013] To overcome these various drawbacks, the invention provides various technical means. Summary of the invention

[0014] First of all, a first objective of the invention is to provide packaging for a medical device that offers effective protection against shocks.

[0015] Another objective of the invention is to provide packaging for a medical device that allows the packaged device to be isolated from vibrations.

[0016] Another objective of the invention is to provide packaging for a medical device that offers protection against contaminants.

[0017] To this end, the invention provides a sterilizable package for a medical device, comprising:

[0018] a) an envelope with two faces separated by a hinge, at least one of the two faces having a cavity to house the device to be packaged, said envelope being insertable into a resealable case;

[0019] b) a resealable housing comprising a lower tank, said tank being arranged with:

[0020] i) a bottom and a side wall running around the entire perimeter of the tank;

[0021] ii) an internal support rim for the casing, at a distance H2 from the bottom of the tank;

[0022] iii) an external rim forming a support for fixing a closure operculum permeable to at least one sterilizing agent;

[0023] iv) the outer edge being at a distance H1 from the inner edge;

[0024] v) the volume of the tank between the heights H1 and H2 forming a suspension volume for the casing;

[0025] vi) at least a part of the periphery of the envelope being held in cooperation with the inner rim so that the cavity is suspended in said suspension zone.

[0026] Thanks to this design, with at least a portion of the casing held at its periphery and the cavity suspended within the casing's suspension zone, the two faces of the casing are separated from the adjacent walls, thus preventing any contact and any risk of impact with the packaged medical device. The casing forms a shock-absorbing membrane that freely supports the packaged product, which is thus completely disconnected from the walls that could damage it in the event of an impact.

[0027] This architecture makes it possible to create packaging that provides triple protection for the packaged device(s): protection against vibration, protection against shock, and protection against contaminants, while also allowing for sterilization of the packaged device. This type of packaging is particularly advantageous for expensive and fragile medical devices such as pacemakers, and / or fragile medical devices with abrasive areas or edges, such as a jaw repair bar, which could damage certain types of packaging.

[0028] According to an advantageous embodiment, the inner rim comprises a plurality of studs and the envelope comprises a corresponding arrangement of openings for inserting the studs and fixing the envelope.

[0029] This arrangement allows the envelope to be held securely, and eliminates micro-movements that could create vibrations.

[0030] Advantageously, each of the heights H1 and H2 is at least 0.5 times the maximum thickness T of the device to be packaged, and preferably at least once the maximum thickness T and even more preferably three times the thickness T or more.

[0031] These clearances at height make it possible to separate the packaged product well from the neighboring walls to avoid any risk of contact with the packaged object, even in the event of a violent impact.

[0032] Advantageously, the casing is made of thermoplastic polyurethane (TPU) or thermoplastic elastomer (TPE) or silicone (LSR “Liquid Silicone Rubber”).

[0033] Thanks to this design and choice of materials, the packaging protects the medical device against shocks and vibrations. These materials are inexpensive and easy to implement.

[0034] According to an advantageous embodiment, the packaging also includes a protective cover for fixing to the inner wall, above the envelope and forming an inverted upper container, the material of the protective cover having a higher level of rigidity than that of the closure lid.

[0035] The lid preferably comprises a plurality of openings arranged on a lid rim and aligned with the openings in the casing. This arrangement allows the lid to be held securely by the studs, without risk of detachment, and without vibration.

[0036] According to an advantageous embodiment, the protective cover and the cushioning envelope have distribution channels for conveying a sterilizing gas from outside the cover to the medical device.

[0037] According to yet another advantageous embodiment, the packaging includes an overpack capable of housing the case, the envelope and a possible protective cover.

[0038] Advantageously, the overwrap has a sealing surface against which an overwrap lid can be applied.

[0039] According to an advantageous embodiment, a range of packaging is provided, the overpack of which has a standard profile compatible with a plurality of boxes of different profiles and / or dimensions. Brief description of the drawings

[0040] All implementation details are given in the following description, supplemented by Figures 1 to 11, presented solely for the purpose of non-limiting examples, and in which: Fig. 1

[0041] [Fig.1] [Fig.1] is an exploded perspective view of a first example of the realization of packaging for a medical device; Fig. 2

[0042] [Fig.2] [Fig.2] is a longitudinal cross-sectional view of the packaging of [Fig.1]; Fig.3

[0043] [Fig.3] [Fig.3] is a cross-sectional view of the packaging of [Fig.1]; Fig. 4

[0044] [Fig.4] [Fig.4] is an exploded perspective view of a second example of production of packaging for a medical device, including a protective lid; Fig. 5

[0045] [Fig.5] [Fig.5] is a longitudinal cross-sectional view of the packaging of [Fig.4]; Fig. 6

[0046] [Fig.6] [Fig.6] is a cross-sectional view of the packaging of [Fig.4]; Fig. 7

[0047] [Fig.7] [Fig.7] is an exploded perspective view of a third example of production of packaging for a medical device, including over-packaging; Fig. 8

[0048] [Fig-8] [Fig.8] is a longitudinal cross-sectional view of the packaging of [Fig.7]; Fig. 9

[0049] [Fig.9] [Fig.9] is an exploded perspective view of a fourth example of production of packaging for a medical device, including an overwrap and a lid; Fig. 10

[0050] [Fig.10] [Fig.10] is a longitudinal cross-sectional view of the packaging of [Fig.9]; Fig. II

[0051] [Fig. 11] [Fig. 11] is an exploded perspective view of a fifth example of an embodiment of packaging for a medical device, the envelope of which allows several devices to be housed. Description of the implementation methods

[0052] Figures 1 to 3 present a first example of an embodiment of a sterilizable package 1 for a medical device 20. As illustrated, the package 1 comprises a wrapper 2 formed from a film of a flexible material described later. The wrapper has a lower face 3 and an upper face 4, each generally flat. The two faces 3 and 4 are separated by a hinge 5 or fold, allowing the upper face 4 to be tilted onto the lower face 3 to close the wrapper. Each face has a thickness of between 0.3 and 1.5 mm. The closure is not permanent, and the wrapper can easily be opened by lifting and tilting the upper face 4 around the hinge 5.

[0053] This envelope 2 allows for the placement and support of the device 20 to be packaged, which can be housed in a cavity 6 provided in at least one of the envelope's faces. In the example shown in Figures 1 to 3, only one cavity is provided, in the lower face 3. Alternatively, as illustrated in [Fig. 4], each of the faces 3 and 4 has a cavity 6. In such a case, they may or may not be identical, depending on the devices to be packaged. The shape and dimensions of the cavities 6 are designed to allow the device to be completely housed. They may be an impression whose contours correspond to the contours of the device, with a slight oversize to facilitate the placement of the device. As shown in [Fig. 1], the cavity may include a gripping area 7, facilitating the placement and removal of the device from the cavity.The cavity is advantageously configured to include one or more clamping zones for the device, allowing for firm retention of the device 20 and the elimination of vibrations. The flexibility and thinness of the material used allow for easy handling during installation and removal.

[0054] As illustrated, the envelope 1 is positionable in a case 10, shaped to allow the packaged device 6 to be suspended, simply held by the envelope, and away from the neighboring walls.

[0055] This suspension is achieved by means of a two-tiered configuration of the housing 10. As clearly visible in [Fig. 1], and also in Figures 2 and 3, the housing 10 forms a lower chamber 11 with a bottom 18 surrounded by a continuous side wall 19 around the entire perimeter of the housing. The first tier, adjacent to the bottom 18, is delimited by a height H2, between the bottom 18 and an internal rim 12 forming a support for at least part of the perimeter of the casing 1. The second tier, of height H1, is delimited between the internal rim 12 and an external edge 13 surrounding the entire wall 19 of the housing. The external edge 13 serves as a bearing surface for attaching a closure lid 15. The lid is advantageously attached to the external edge 13 by gluing, although other attachment methods such as clipping are also compatible.

[0056] Thus, as clearly visible in the cross-sections and longitudinal sections of Figures 2 and 3, the heights H1 and H2 of the two levels of the housing allow for the formation of a suspension volume 14. Thanks to this volume 14 and the casing 1 placed against the inner rim 12, the device 20 is positioned in suspension, protected from shocks and vibrations.

[0057] To further secure the positioning of the envelope 2 within the casing 10, lugs 16 are arranged on the inner rim 12. In the illustrated example, the lugs 16 are positioned at the four corners (for a parallelepiped-shaped package), and the envelope 2 has a corresponding number and positioning of openings 17 into which the lugs 16 can be inserted to securely fasten the envelope. The dimensions of the lugs and the corresponding openings are preferably designed with a tight fit.

[0058] To allow sufficient separation of the packaged device 20 from the adjacent walls of the packaging, and thus a sufficient suspension volume 14, each height H1 and H2 is at least 0.5 times the maximum thickness T of the device 20 to be packaged. Preferably, these heights are at least one time the maximum thickness T. According to an even more preferred embodiment, the heights H1 and H2 are at least three times the thickness T or more.

[0059] Figures 4, 5, and 6 show an alternative embodiment of a package 1 having similar or identical characteristics to that shown in Figures 1 to 3, with two differentiating elements. First, the envelope 1 has two cavities 6, one arranged in each face of the envelope. Second, the package 1 also includes a protective lid 21, which can be positioned on top of the envelope 2 and forms an inverted upper container 22 opposite the containerThe device 20 remains suspended in the volume 14, but with an additional protective layer formed by the bottom of the upper container 22, protecting the envelope 2 in case the lid 15 is damaged or accidentally removed. As illustrated, the protective cover 21 is positioned and sized so that the bottom of the upper container 22 is in the immediate vicinity of the lid 15, thus maintaining a maximum suspension volume 14. The cover is held in place similarly to the envelope 2, by being inserted into the notches 16 of the housing 10, over the envelope 2. For this purpose, the cover 21 has a plurality of openings 23 arranged on a rim 24 of the cover and aligned with the openings 17 of the envelope 2. The dimensions of the notches and the corresponding openings are preferably designed with a tight fit.The cover 21 provides additional protection in case an object manages to pass through the operculum 15.

[0060] Figures 7 and 8 show another embodiment of a package 1 having similar or identical characteristics to that shown in Figures 1 to 3, with two differentiating technical features. As illustrated, the package 1 also includes a protective overwrap 25, which can be positioned under the case 10, shaped and sized to accommodate all the elements described above, in particular a case 11, an envelope 2, an optional protective lid 21, and a seal 15.

[0061] To ensure its closure, the overwrap 25 has a sealing surface 26 against which an overwrap lid 27 can be applied. In the illustrated example, the overwrap lid 27 is similar to the lid 15 of the case 10 but with a larger dimension corresponding to the sealing surface 26.

[0062] To optimize the industrialization process and costs, a range of packaging is planned in which the overwrap 25 is advantageously designed with a single standard profile compatible with a plurality of cases 10 of different profiles and / or dimensions. This feature allows, for a single type of overwrap, the packaging of different types of devices.

[0063] Figures 9 and 10 illustrate an example of an embodiment similar to that described in Figures 7 and 8 but also comprising a cover 21, similar to that previously described in relation to Figures 4 to 6.

[0064] Figure 11 illustrates another embodiment in which the envelope 2 is designed to contain more than one device 20 to be packaged. In the illustrated example, three complementary devices are each housed in a cavity 6 of a specific shape and size. In this example, the packaged items could be screws, ball joint heads, positioning sensors for surgical robots, or other items. An envelope with multiple devices can be offered with or without lid 21 and / or with or without overwrap. MATERIALS

[0065] The envelope 2 is made of flexible material, to dampen the vibrations generated by a single impact or series of shocks, but sufficiently rigid to ensure that the device remains suspended in the suspension volume.

[0066] Thermoplastic polyurethane (TPU), thermoplastic elastomer (TPE), or silicone rubber (LSR) are preferably used. TPU has the advantage of particularly high abrasion resistance, which makes it possible to package devices with abrasive or sharp edges without risk of damage to the casing. The table below shows the mechanical resistance in terms of elasticity (elongation at break) for the different materials that can be used for the casing. Material Forming Technology (Elongation at Break) Thermoforming Injection Molding TPU 350-500% 300-700% TPE 300-600% 300-800% LSR — 300-800%

[0067] The casing 10, the lid 21, and the overwrap 26 use identical or similar material characteristics, with a higher level of rigidity than the outer casing 2, for impact protection. Amorphous polyethylene terephthalate (APET) or glycol-modified polyethylene terephthalate (PETG) is preferably used. APET and PETG have excellent impact resistance and are recyclable. PETG has greater flexibility than APET. Polypropylene (PP) or polycarbonate (PC) can also be used.

[0068] The lids 15 and 27 are advantageously made of a selectively airtight material, for example, a non-woven textile sheet of high-density polyethylene (HDPE) fibers marketed under the name "Tyvek" (registered trademark). These sheets have a thickness of between 0.5 and 10 µm. By "selectively airtight," we mean a material whose characteristics allow it to regulate exchanges from the outside to the inside of the package. In addition, the material creates a sterile barrier in that it prevents contamination that could occur through microorganisms, bacteria, or biologically active substances that could come into contact with or be in the immediate vicinity of the package. This same selectively airtight material is also permeable to at least one sterilizing agent (gas, steam, radiation, or other), such as, for example,

[0069]

[0070] The sterilizing agent is a type of ethylene oxide or a high-temperature decontaminating or sterilizing fluid, such as steam up to 130°C. This allows for the sterilization of the packaged device and its packaging. To enable the sterilizing agent to reach the packaged device, internal packaging components such as the protective lid 21 and the shock-absorbing sleeve 2 have openings or distribution channels for conveying a sterilizing gas from outside the lid to the medical device 20. Thanks to the previously described architecture and the judicious choice of materials as outlined, the packaging protects the medical device against shocks and vibrations. Indeed, an overly rigid casing would transmit shocks and vibrations to the device, which would then be inadequately protected. Furthermore, the packaging meets the requirements of ATSM 4169 / 5276 / 6673 and ISTA 3. List of reference signs 1. Sterilizable packaging 2. Envelope 3. Underside of the envelope 4. Upper surface of the envelope 5. Hinge 6. Cavity 7. Gripping area 8. 9. 10. Case 11. Lower tank 12. Inner rim 13. Outer border 14. Suspension volume 15. Operculum 16. Plot 17. Opening 18. Background 19. Side wall 20. Medical device 21. Lid 22. Upper tank 23. Opening the lid 24. Lid rim 25. 26. 27. Overwrap Closure surface Overwrap lid

Claims

Demands

1. Sterilizable packaging (1) for a medical device (20), comprising: a) a two-sided (3, 4) envelope (2) separated by a hinge (5), at least one of the two sides having a cavity (6) for housing the device (20) to be packaged, said envelope (2) being insertable into a resealable case (10); b) a resealable case (10) comprising a lower container (11), said container being arranged with: i) a bottom (18) and a side wall (19) extending around the entire perimeter of the container (11); ii) an internal rim (12) for supporting the envelope (2), at a distance H2 from the bottom (18) of the container (11); iii) an external rim (13) forming a support for attaching a closure seal (15) permeable to at least one sterilizing agent; (iv) the outer rim (13) being at a distance H1 from the inner rim (12); (v) the volume of the tank (11) between the heights H1 and H2 forming a suspension volume (14) for the envelope (2);(vi) at least a part of the periphery of the envelope (2) being held in cooperation with the inner rim (12) so that the cavity (6) is suspended in said suspension volume (14).

2. Packaging according to claim 1, wherein the inner rim (12) has a plurality of studs (16) and the envelope (2) has a corresponding arrangement of openings (17) for inserting the studs (16) and fixing the envelope.

3. Packaging according to any one of claims 1 or 2, wherein each of the heights H1 and H2 is at least 0.5 times the maximum thickness T of the device (20) to be packaged, and preferably at least once the maximum thickness T and even more preferably three times the thickness T or more.

4. Packaging according to any one of claims 1 to 3, wherein the envelope (2) is made of TPU or TPE or silicone.

5. Packaging according to any one of claims 1 to 4, wherein the resealable case (10) has a protective cover (21) for attachment to the inner wall (12), above the envelope (2) and forming an upper tank (22), the material of the protective cover (21) having a higher level of rigidity than that of the lid (15).

6. Packaging according to claim 5, wherein the lid (21) has a plurality of openings (23) arranged on a rim (24) of the lid and in alignment with the openings (17) of the envelope (2).

7. Packaging according to any one of claims 5 or 6, wherein the protective cover (21) and the cushioning envelope (2) have distribution channels for conveying a sterilizing gas from outside the cover to the medical device (20).

8. Packaging according to any one of claims 1 to 7, also comprising an overpack (25) capable of housing the case (10), the envelope (2) and a possible protective cover (21).

9. Packaging according to claim 8, wherein the overwrap (25) has a closing surface (26) against which an overwrap lid (27) is capable of being applied.

10. Packaging according to any one of claims 8 or 9, wherein the overpack (25) has a standard profile compatible with a plurality of cases (10) of different profiles and / or dimensions.

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