STAGGERED PACKAGE TRAY ASSEMBLY FOR MEDICAL DEVICES

Abstract

The present invention relates to a packaging 100 for medical devices 150, 160, 170, 180, 185, 190 comprising an outer packaging 110 defining an interior space of the outer packaging 110, and at least a first tray 130 and a second tray 140 configured to be placed in the interior space of the outer packaging 110, wherein the second tray 140 comprises at least one protrusion 141 on a lower side 140b of the second tray 140, the first tray 130 comprises at least one recess 131 on an upper side 130a of the first tray 130, the at least one recess 131 being aligned with the at least one protrusion 141, and the second tray 140 is configured to be placed on the first tray 130 such that the protrusion 141 engages the recess 131.

Description

[Technical field]

[0001] The present invention relates to packaging for medical devices. [Background technology]

[0002] A general challenge with such packaging is to reduce the external size, volume and weight whilst ensuring that the packaging is convenient to handle by users, particularly physicians / clinicians. Summary of the Invention

[0003] The problem that the present invention aims to solve is therefore to provide a packaging, in particular for medical devices, which is improved with regard to the above-mentioned properties.

[0004] This problem is solved by a package according to claim 1. Preferred embodiments are set out in the dependent claims and are described below.

[0005] According to claim 1, there is provided a package for a medical device, comprising: - an outer packaging defining an interior space of the outer packaging; - at least a first tray and a second tray configured to be disposed in an interior space of the outer packaging, the second tray comprising at least one protrusion on an underside of the second tray, the first tray comprising at least one recess on an upper side of the first tray, the recess being aligned with the at least one protrusion, and the second tray being configured to be disposed on the first tray such that the protrusion engages the recess; A package comprising:

[0006] In particular, the packaging is compatible with sterilization. The stacking of trays overcomes common problems presented by conventional tray packaging approaches. In particular, the staggered tray assembly has a reduced overall size, volume and weight. This makes the staggered tray assembly easier to transport and store. Thus, less shelf space is required at manufacturing sites, distribution centers and hospitals, allowing for a larger inventory to be stored at any one time.

[0007] According to a preferred embodiment of the packaging, the at least one projection comprises a base forming a spacer and an engagement portion protruding from the base, the engagement portion being configured to be inserted (particularly in the form of a form fit) into the at least one recess such that a front side of the base rests on an upper side of the first tray. In particular, the at least one projection and the at least one recess are deep-drawn in each tray.

[0008] Further, in one embodiment, the at least one projection and the at least one recess are tapered to provide a press fit when the at least one projection is inserted into the respective recess, and / or the at least one projection and the at least one recess are configured to provide a snap fit when the at least one projection is inserted into the at least one recess.

[0009] Further, according to one embodiment of the packaging, the second tray comprises a plurality of protrusions on an underside of the second tray and the first tray comprises a plurality of corresponding recesses on an upper side of the first tray, each recess being aligned with one of the protrusions, and the second tray is configured to be placed on the first tray such that each protrusion engages with a corresponding recess. In particular, each portion and each recess can be designed as described above for at least one protrusion and corresponding recess. In particular, when the two trays are stacked one on top of the other as described above, the trays comprise two pairs of protrusions and corresponding recesses arranged diagonally opposite each other.

[0010] According to yet another embodiment, the first tray and / or the second tray each comprise at least one recess for receiving at least one component of a medical device respectively.

[0011] According to a further embodiment of the invention, the first tray and / or the second tray comprises at least one retaining element configured to hold each component in place when the component is received in the associated recess.

[0012] Moreover, in one embodiment, the packaging comprises an inner packaging in the form of a sterilization pouch configured to hermetically enclose the tray when the tray is placed in the interior space of the outer packaging and carrying the medical device components. In particular, the outer packaging may be a cardboard box.

[0013] Further, in one embodiment of the packaging, the first tray comprises at least a first material and the second tray comprises at least a second material, the first material and the second material being different from each other, in particular the first material and the second material being different in at least one property selected from the group consisting of absorption coefficient for light (the absorption coefficient determines how far light of a particular wavelength can penetrate through a material before being absorbed), modulus of elasticity, flexural modulus, density, and color.

[0014] Additionally, in one embodiment, the first tray is more flexible than the second tray so as to provide a cushion for the second tray for impact resistance.

[0015] Additionally, according to one embodiment, the second tray may contain a light absorbing dye and / or a light blocking material (such as aluminum foil) to protect light sensitive components of the medical devices placed on the first tray from excessive exposure to ultraviolet radiation.

[0016] Additionally, in one embodiment of the packaging, the first tray and / or the second tray may include insulating components and / or insulating materials (such as heat reflective foils) to protect heat-sensitive components of the medical device present in the space formed between the first tray and the second tray from excessive exposure to heat or to maintain a stable internal temperature relative to the external temperature (e.g., to prevent accumulation of hot or cold during storage and transport).

[0017] Additionally, according to yet another embodiment of the packaging, the first tray and / or the second tray may include a permeation control component and / or material (e.g., a material that is impermeable to gases and / or liquids) to protect permeation sensitive components of the medical device present in the space formed between the first tray and the second tray from gases and / or liquids (e.g., water and / or oxygen). Alternatively, the first tray and / or the second tray may include a semi-permeable material that allows gases, particularly ethylene oxide vapor, to move more rapidly across the first tray and the second tray.

[0018] Additionally, the tray preferably comprises or is formed from a plastic material such as polyethylene, polypropylene, polyethylene terephthalate, glycol modified polyethylene terephthalate, polycarbonate and copolymers of the above materials.

[0019] Furthermore, according to one preferred embodiment, the first tray and / or the second tray are formed from a plastic material by a deep drawing process.

[0020] In the following, examples of the invention as well as further features and advantages of the invention are described with reference to the drawings. [Brief description of the drawings]

[0021] [Figure 1] FIG. 1 is an exploded view of one embodiment of a packaging of the present invention for medical devices, particularly in the form of a catheter device. [Diagram 2] FIG. 2 is a top view of a first tray of the packaging embodiment shown in FIG. 1. [Diagram 3] FIG. 2 is a top view of a second tray of the packaging embodiment shown in FIG. 1. [Figure 4] FIG. 4 is a top view of the first and second trays shown in FIGS. 1-3, stacked one on top of the other.

[0022] The present invention relates to a package 100 comprising at least a first tray 130 and a second tray 140 (or more than two such trays) stacked one on top of the other. Such a package is particularly adapted to package medical devices comprising elongated components such as catheter devices. As shown in FIG. 1, in addition to the trays 130, 140, the package 100 may comprise an outer package 110, in particular formed as a cardboard box, and an inner package 120, for example formed as a sterilization pouch, for enclosing the first tray 130 and the second tray 140. The package 100 may further comprise, as an exemplary embodiment, a number of delivery coils 150, 160 for protecting an assortment of medical devices 170, 180, 185, 190 arranged on the trays 130, 140, a compliance card 200, and an Instructions For Use (IFU) 210.

[0023] In particular, in one embodiment, the medical device may be a catheter device comprising a support catheter 185, a handle 180 with a hemostasis valve, a dilatation catheter 170, and a balloon catheter 190. For further protection, the support catheter 185 and the dilatation catheter 170 may be protected by a delivery coil 150 that at least partially surrounds the latter components 170, 185, while the balloon catheter 190 may be protected by a delivery coil 160 that at least partially surrounds the balloon catheter 190.

[0024] Each of the at least two trays 130, 140 may have a recess 135, 145, with the balloon catheter 190 and surrounding delivery coil 160 inserted into the recess 135 of the first tray 130, while the support catheters 180, 185 and the dilation catheter 170 and surrounding delivery coil 150 are inserted into the recess 145 of the second tray 140.

[0025] 2 and 3, each tray 130, 140 preferably incorporates one or more press-fit recesses 131 and press-fit protrusions 141 that correspond to each other in terms of location, shape and height / depth, so that two or more trays 130, 140 can be placed directly on top of each other and partially recessed into each other. The overlap in depth reduces the material or wall strength of the trays 130, 140 and therefore the total weight of the package. In particular, each protrusion 141 may comprise a base 142 forming a spacer and an engagement portion 143 protruding from the base / spacer 142, the engagement portion 143 being configured to engage, in particular in a form-fit manner, within the associated recess 131 such that the front side 142a of the base 142 rests on the top side 130a of the first tray 130.

[0026] Each tray 120, 130 may further include elements such as retaining elements, guiding inserts or locking embossments for temporarily locking said components of the medical device into correspondingly formed recesses 135, 145 which act as containers for each component so that each component can be placed and locked into the respective tray 130, 140. Each tray 130, 130 may be shaped as required by the geometry of the component / medical device to be accommodated thereunder, such that the shape of each tray 130, 140 may differ from one another and be individually adapted to suit packaging requirements.

[0027] The protrusions 141 and recesses 131, or corresponding embossments typically present on two or more trays 130, 140, may be wedge shaped or slightly tapered, or may include horizontal protrusions and corresponding cavities that provide a press-fit or snap-fit ​​assembly when contacted together. To separate the engaged trays 130, 140 (see FIG. 4), a user, when desired, releases the tangible protrusions / hooks to release the engaged trays 130, 140 from each other, thereby allowing access to the contents of each tray 130, 140.

[0028] The height / depth ratio of the protrusions / recesses 141, 131 (e.g., embossments) can be adjusted to adjust the residual height between the trays 130, 140 when engaged to facilitate proper airflow between the trays during ethylene oxide (ETO) sterilization.

[0029] The staggered arrangement improves packaging stability, crush resistance and / or bending resistance of the trays 130, 140, and prevents the trays 130, 140 from moving in an unexpected manner relative to one another during shipping. Two or more trays 130, 140 can be packaged together in a single assembly in the sterilization pouch 120, thereby avoiding the need for additional packaging materials, such as blister foils, for each tray 130, 140. Additionally, the staggered assembly can significantly reduce the overall packaging footprint, as it requires less height than simply stacking two trays on top of one another.

[0030] Because the trays 130, 140 can be made from a combination of different materials having different properties, some properties can be advantageously modified, such as light absorption coefficient, elastic modulus, flexural modulus, weight / density, color, among others. Thus, by combining the same or different tray materials, additional desirable properties can be obtained that are not available in a single type of tray made from the same material.

[0031] Impact resistance is improved by adding a first tray 130 made of a fairly flexible, pliable, foamed or generally cushioning material to a second tray 140 made of a relatively rigid, brittle and / or inflexible material and placing the first tray 130 below the second tray 140, thereby providing better protection for the fragile materials that would otherwise often be destroyed during the rigors of shipping.

[0032] Additionally, by providing a light-blocking material such as a light-absorbing dye or aluminum foil in the second tray 140 and placing the second tray 140 on top of the first tray, light attenuation / absorption can be improved, in particular to protect the light-sensitive material present in the first tray 130 from excessive exposure to natural effects such as the sun or ultraviolet radiation.

[0033] Additionally, the first and second trays may be provided with insulating components and / or materials such as heat reflective foils, and the second tray 140 may be placed on top of the first tray 130 to improve the insulating properties, in particular to protect heat sensitive components in the space formed between the first tray 130 and the second tray 140 from excessive heat exposure. Alternatively, this tray configuration may be employed to keep the internal temperature stable relative to the external temperature, preventing the accumulation of heat or cold during storage and transport.

[0034] Additionally, permeation control materials, such as permeation control components and / or gas barriers, may be provided in the first tray 130 and / or second tray 140, and the second tray 140 may be positioned above the first tray 130 to improve gas or liquid permeability and / or barrier properties, thereby protecting permeation sensitive components in the space formed between the first tray 130 and the second tray 140 from water and / or oxygen. Alternatively, semi-permeable materials may be provided to allow ethylene oxide vapor to move more quickly across the packaging barrier formed by the first tray 130 and the second tray 140.

[0035] Preferably, the trays 130, 140 of the package 100 are preferably formed by a conventional deep drawing process. The staggered packaging assembly 100 according to the present invention may be applied to any product in general, including medical devices. There are no fundamental technical challenges associated with the present technology, as it utilizes conventional manufacturing processes, particularly deep drawing.

Claims

1. A packaging (100) for a medical device (150, 160, 170, 180, 185, 190), comprising: an outer packaging (110) defining an interior space of the outer packaging (110); At least a first tray (130) and a second tray (140) configured to be placed in the interior space of the outer packaging (110), wherein the second tray (140) comprises at least one protrusion (141) on a lower side (140b) of the second tray (140), and the first tray (130) comprises at least one recess (131) on an upper side (130a) of the first tray (130), the at least one recess (131) being aligned with the at least one protrusion (141), and the second tray (140) is configured to be placed on the first tray (130) such that the protrusion (141) engages with the recess (131); A package (100) comprising:

2. 2. The package of claim 1, wherein the at least one protrusion (141) comprises a base (142) forming a spacer and an engagement portion (143) protruding from the base (142), the engagement portion (143) being configured to be inserted into the at least one recess (131) so that a front side (142a) of the base (142) rests on the upper side (130a) of the first tray (130).

3. 3. Packaging according to claim 1 or 2, wherein said at least one protrusion (141) and said at least one recess (131) are formed in each of said trays (130, 140) by deep drawing.

4. 3. The packaging of claim 1 or 2, wherein the at least one protrusion (141) and the at least one recess (130) are tapered to provide a press fit when the at least one protrusion (141) is inserted into the respective recess (130), and / or the at least one protrusion (141) and the at least one recess (130) are configured to provide a snap fit when the at least one protrusion (141) is inserted into the at least one recess (130).

5. 3. The package of claim 1, wherein the second tray (140) comprises a plurality of protrusions (141) on the lower side (140b) of the second tray (140), and the first tray (130) comprises a plurality of corresponding recesses (131) on the upper side (130a) of the first tray (130), each recess (130) being aligned with one of the protrusions (141), and the second tray (140) is configured to be placed on the first tray (130) such that each protrusion (141) engages with a corresponding recess (131).

6. 3. The packaging of claim 1 or 2, wherein the first tray (130) and / or the second tray (140) comprises at least one recess (135, 145) for receiving a component of the medical device.

7. 7. The packaging of claim 6, wherein the first tray (130) and / or the second tray (140) comprises at least one retaining element configured to hold each of the components in place when the each of the components is received in the associated at least one recess (134, 145).

8. 3. The package of claim 1, wherein the package (100) comprises an inner package (120) in the form of a sterilization pouch configured to hermetically enclose the tray (130, 140) when the tray (130, 140) is placed in the interior space of the outer package (110).

9. 3. Packaging according to claim 1 or 2, wherein the outer packaging (110) can be a cardboard box.

10. 3. The package of claim 1 or 2, wherein the first tray (130) comprises at least a first material and the second tray (140) comprises at least a second material, the first material and the second material being different from each other, in particular, the first material and the second material being different in at least one property selected from the group consisting of light absorption coefficient, elastic modulus, bending modulus, density, and color.

11. 3. The package of claim 1 or 2, wherein the first tray (130) is more flexible than the second tray (140) so as to form a buffer for the second tray (140) to provide impact resistance.

12. 3. The packaging of claim 1 or 2, wherein the second tray (140) contains a light-absorbing dye and / or a light-blocking material to protect light-sensitive components of the medical device placed on the first tray (130) from excessive exposure to ultraviolet radiation.

13. 3. The packaging of claim 1 or 2, wherein the first tray (130) and / or the second tray (140) include insulating components and / or insulating materials to protect heat-sensitive components of the medical device present in the space formed between the first tray (130) and the second tray (140) from excessive exposure to heat or to maintain a stable internal temperature relative to the external temperature.

14. 3. The package of claim 1 or 2, wherein the first tray (130) and / or the second tray (140) include permeation control components and / or permeation control materials to protect permeation-sensitive components of medical devices present in a space formed between the first tray (130) and the second tray (140) from gases and / or liquids, or the first tray (130) and / or the second tray (140) include semi-permeable materials that allow gases, particularly ethylene oxide vapors, to move more rapidly across the first tray (130) and the second tray (140).

15. 3. The package of claim 1 or 2, wherein the first tray (130) and / or the second tray (140) are formed by a deep drawing process.

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