STERILE PACKAGING WITH INTEGRATED SUSPENSION

Description

Technical field

[0001] The present disclosure relates to a medical sterile packaging for a medical product.

[0002] Medical products must be packaged appropriately to maintain their sterility and protect them from damage during transport and / or storage. In recent years, sterile packaging with at least two sterile barriers, preferably made of a plastic material and / or a plastic film, and an outer packaging, for example made of cardboard, has become the standard. State of the art

[0003] It is known to store medical products such as implants, instruments, accessories, especially hoses, containers, etc., syringes and similar medical utensils in sterile packaging consisting of an inner sterile barrier immediately surrounding the medical product, an outer sterile barrier containing the inner sterile barrier, and an outer packaging containing the outer sterile barrier.

[0004] Often, at least one of the sterile barriers is additionally made of a puncture-resistant fabric to prevent the medical product from leaking out. Sensors are also frequently incorporated within the sterile barriers to detect air ingress and thus indicate that the medical product inside is no longer sterile.

[0005] Shock-absorbing packaging materials such as plastic films are also commonly used. These films form bubble- or tube-like compartments / pockets containing trapped air, creating individual / separate air cushions evenly distributed across the film. Their purpose is to protect the packaged product from external influences such as vibrations or impacts. These cushions can be created, for example, by laminating two plastic films together, forming self-contained air pockets at the relevant points.

[0006] Alternatively, it is also known to provide outer packaging made of a multi-layered cardboard material with two parallel-spaced top plates and a wave-shaped intermediate plate, which consequently deforms under external force and thus acts as a shock absorber.

[0007] Although the aforementioned packaging material can guarantee both sterility and impact protection, problems have arisen, particularly with regard to the latter property and especially in the medical field, as indicated below: Shock-absorbing cardboard packaging must be stored dry to maintain its shape, especially the shock-absorbing inner layer. These materials are also generally inelastic, meaning they deform plastically under external forces and therefore lose their original cushioning properties. Shock-absorbing plastic films are typically pre-made with standardized padding pocket sizes and spacing. In unfavorable conditions, products packaged within these films can protrude in sections between the padding pockets, creating unprotected, exposed product areas. Therefore, such products are often wrapped in multiple layers of shock-absorbing plastic film to cushion any protruding product sections, which, however, significantly increases the overall packaging thickness.

[0008] WO 2006 / / 028 933 A2 discloses a packaging in which two films are arranged in a suitcase-shaped protective package. When two halves of the protective package are folded over, the films lie against each other and form a receiving space for a medical product.

[0009] In general packaging, it is known to place the items to be protected between two air cushions to protect them from shocks. For example, WO 98 / 51585 A1 and WO 95 / 02548 A1 each show an inflatable air cushion that can be folded around the item in such a way that the item to be protected is surrounded by the air cushion on two sides.

[0010] US Patent 5,487,470 A also discloses a sterile packaging for medical products with two sterile barriers. Brief description of the Revelation

[0011] Based on the aforementioned prior art, one objective of the present disclosure is to provide a medical sterile packaging for medical products which provides suitable protection against external forces and ensures sufficient sterility of the product packaged therein.

[0012] This problem is solved by a medical sterile packaging with the features of claim 1.

[0013] The present disclosure therefore relates to a medical sterile packaging for packaging a medical product, comprising a first sterile barrier prepared and configured to form a first receiving chamber for receiving the medical product in a preferably vacuum-sealed manner, a second sterile barrier prepared and configured to form a second receiving chamber for receiving the first sterile barrier, and an outer protective packaging prepared and configured to receive the first and the second sterile barriers. According to the disclosure, the second sterile barrier has a film or a double membrane forming at least two air pockets. The two air pockets are separated from each other by a predefined fold-over or folding edge, whereby, in the folded-over state of the double membrane orThe foil should be positioned along the folded or creased edge so that the two air pockets lie flush against each other, creating a second recording space between them.

[0014] In other words, the present disclosure consists in that at least one of at least two sterile barriers comprises or is a film made of the double membrane. One membrane of the film forms at least two air pockets bulging on only one side of the film, whereas the other membrane remains essentially planar. The film further has a predefined folding or creasing edge extending between the two air pockets such that, when the film is folded over, the air pockets lie in pairs along the predefined folding or creasing edge, essentially aligned, and the planar membrane sections lie in section, essentially flat against each other, so that a weldable / sealable receiving space can be created between the planar, flatly adhering membrane sections in the region of the aligned air pockets, preferably by plastic or elastic deformation of the planar, flatly adhering membrane sections.

[0015] In other words, the sterile packaging comprises the first sterile barrier, the second sterile barrier, and the outer protective packaging. The second sterile barrier is a two-layer film. Air is sealed between the two layers, creating air pockets. These air pockets do not necessarily have to be symmetrical; they can have one concave side and one flat side. The air pockets are folded over a hinge edge so that the flat sides lie against each other. The space between these flat sides / membrane sections forms the receiving area for the first sterile barrier.

[0016] The core of the present disclosure therefore consists in the fact that the at least two air pockets are folded around the first sterile barrier in such a way that the air pockets are arranged one above the other and (completely) enclose / surround the first sterile barrier in order to (completely) enclose the product to be stored between them. The receiving space for the first sterile barrier is thus formed at the contact surface of the two air pockets.

[0017] Essentially planar in this context means that the membrane is flat. However, pressure fluctuations in the air bubble, for example, can cause a slight convex bulge or an equally slight concave indentation of the elastic membrane. These minor deviations from a planar membrane are also to be considered essentially planar within the meaning of the disclosure.

[0018] The folding edge can, in particular, form a fold line that separates two adjacent gas cushions, especially air pockets / air cushions. The folding edge connects the two membranes of the double membrane. The folding edge can be formed either by spot welding or by linear welds, at least in sections. If the folding edge is created by spot welding, the adjacent air cushions can be connected in sections such that the air in the individual cushions can communicate with each other. The weld can also extend over the entire length of the folding edge, so that the individual air cushions are independent of each other. Furthermore, the linear welds can be interrupted, allowing the individual air cushions to be connected.Several, for example two, weld seams or lines can be arranged next to each other, especially parallel, and form the folding or folding edge between the air cushions.

[0019] The present disclosure offers the following advantages: Since the sterile packaging has two sterile barriers, the medical product is doubly protected against sterility within the sterile packaging.

[0020] The air pockets protect the medical product from external influences such as shocks or vibrations.

[0021] Because the air pockets are integrated into the sterile barrier, no additional air cushions or other cushioning materials need to be added to the outer protective packaging. This eliminates parts and additional steps in the packaging process.

[0022] Finally, when the film is folded, the two air pockets form a gap into which the product, already sealed in the first sterile barrier, can be completely inserted (with elastic deformation of the second sterile barrier), thus completely surrounding it with the (single-layer) air cushion. This ensures optimal product protection and minimizes packaging material usage.

[0023] Preferably, the second sterile barrier has two air pockets separated by one or more predefined fold-over or folding edges, which can be folded over such that a further pocket for receiving the first sterile barrier is located between the air pockets. The first sterile barrier containing the medical product is inserted into the further pocket of the second sterile barrier and sealed therein, preferably under vacuum. In addition to the further pocket, the second sterile barrier can also have the two air pockets separated from the further pocket by the at least one or more predefined fold-over or folding edges. This design is very easy to manufacture.

[0024] In other words, the second sterile barrier has two sections designed as air pockets and one section designed as a further receiving pocket, which are joined together as a single component via fold-over or pleated edges. The further receiving pocket serves to hold the first sterile barrier and thus the medical product within it. This virtually automatically determines the relative position of the medical product to the two air pockets as soon as the medical product, along with the first sterile barrier surrounding it, is placed in the receiving pocket and, if necessary, secured by vacuum sealing the receiving pocket. When the air pockets are then folded over along their edges, the medical product automatically lies in the correct orientation between the air pockets.

[0025] In With an advantageous design, the air pockets can be folded around the additional (receiving) pocket in such a way that the additional pocket is surrounded by the air pockets on at least two sides. The air pockets are at least partially compressible. This means that when the additional pocket with the first sterile barrier rests between the two air pockets, the air pockets are (partially) compressed, forming the receiving space for the additional pocket or the medical product along with its first sterile barrier within the additional pocket. This ensures that the medical product is cushioned and protected by the air pockets.

[0026] According to a further optional feature of the disclosure, the two air pockets are arranged on opposite sides of the additional pocket. That is, an air pocket is arranged on each side of the additional pocket and is integrally connected to the additional (receiving) pocket via fold-over or folding edges. The air pockets and the additional pocket are thus spatially separated or spaced apart by these fold-over or folding edges, acting like hinges. In this embodiment, each air pocket is folded over its fold-over or folding edge onto a opposite side of the additional pocket (in a Z-shape). In this way, the additional pocket is enclosed by the air pockets.

[0027] Alternatively, the two air pockets can be arranged on the same side of the second pocket containing the first sterile barrier. This means that the air pockets are positioned side by side on one side of the pocket. The air pockets are separated from each other by the folded edges. The air pockets are also separated from the second pocket by the folded edges. When folding the air pockets around the second pocket, the air pocket adjacent to the second pocket is folded first. Then, the second air pocket is folded onto the side of the second pocket that is opposite the first air pocket.

[0028] According to another optional feature of the disclosure, the film of the second sterile barrier is made of a double membrane, wherein one membrane curves concavely outwards and the other remains planar. In other words, the film consists of two films. A first film forms the concave pockets, while a second film is planar and seals the pockets. The concave side of the film allows sufficient volume for the air within the air pockets. The planar membrane allows the planar membrane sections to lie as flat against each other as possible after being folded over.

[0029] According to a further optional feature of the disclosure, when the film is folded over, the planar membrane sections lie essentially flat against each other. These flat, adjacent planar membrane sections form the receiving space for the first sterile barrier. In this way, the planar membrane sections enclose the first sterile barrier as completely as possible. The second sterile barrier is formed by enclosing the first sterile barrier with the membrane and subsequently sealing the planar membrane sections.

[0030] According to a further optional feature of the disclosure, the weldable / sealable receiving space between the planar, adjacent membrane sections in the area of ​​the aligned air pockets can be created. The receiving space is preferably created by plastic or elastic deformation of the planar, adjacent membrane sections. The elastic membrane deforms and assumes the shape of the first sterile barrier. Since the membrane assumes the shape of the first sterile barrier, the first sterile barrier is largely enclosed. This results in good damping with minimal movement and sterile packaging.

[0031] According to another optional feature of the disclosure, the second sterile barrier is a film with a double membrane. A first, convex membrane of the double membrane is made of a rigid material, and a second, planar membrane is elastic. The first membrane is relatively rigid so that it can be deep-drawn. This deep-drawing process creates the air pockets. Furthermore, the rigid membrane acts as a puncture barrier, preventing a sharp instrument from penetrating the sterile packaging. The second membrane is elastic so that it can conform to the shape of the first sterile barrier and largely encompass / enclose it.

[0032] According to a further optional feature of the disclosure, the first sterile barrier comprises two films and is designed and configured to weld / seal the medical product between the two films in such a way that relative movement between the films and the medical product is reduced. The medical product is thus welded so tightly between the two films that it cannot move or shift within them. This reduced relative movement between the films and the medical product eliminates or at least minimizes particle generation due to friction between the films and the medical product. Particles can contaminate sterile medical products, potentially necessitating repeated cleaning and sterilization. The tightly welded films therefore constitute a sterile barrier and additionally provide effective protection against particles and abrasion.

[0033] According to another optional feature of the disclosure, the first sterile barrier is stored sterilely within the second sterile barrier. To enable the functionality of a double sterile barrier, or double sterility, the first sterile barrier must be placed inside another sterile package / second sterile barrier. This is the second sterile barrier. Since the second sterile barrier encompasses and seals the first sterile barrier, it functions as a sterile barrier.

[0034] According to a further optional feature of the disclosure, the sterile packaging has multiple seals. A first and a second seal seal the first sterile barrier; a third, a fourth, and a fifth seal each seal the double membrane adjacent to the air pockets of the second sterile barrier. A sixth seal seals the two overlapping air pockets together.

[0035] The first and second seals seal the two films of the first sterile packaging on both sides of the medical product. Three seals hold together the two membranes of the double membrane of the second sterile barrier. The two membranes can also be two films welded together by the seals. The three seals are located on the two outer sides of the air pockets and between the air pockets. The final seal seals the two folded-over, overlapping air pockets together to form the second sterile barrier around the first. The seals ensure the sterility of the individual packaging layers or barriers.

[0036] According to another optional feature of the disclosure, the second sterile barrier has exactly two air pockets. These two air pockets allow exactly one medical product to be stored in a steam-insulated manner between them. It is, of course, also conceivable that the second sterile barrier has multiple air pockets. This would allow multiple medical products to be stored in a steam-insulated manner.

[0037] The problem described in this disclosure can also be solved by a method for producing a sterile packaging according to one of the foregoing aspects. The disclosed method comprises the following steps: The first sterile barrier is produced by sealing two films (around the medical product). The second sterile barrier is produced, for example, by deep drawing and subsequent sealing of the air pockets. The first sterile barrier is placed onto one of the planar membrane sections of the second sterile barrier or inserted into a receiving pocket between the two air pockets, which are joined together with the two air pockets to form a single component and spatially spaced apart from each other by means of fold lines. After the first sterile barrier is placed / inserted, one of the air pockets is folded over such that the air pockets form the first sterile barrier or the second sterile barrier.Enclose the receiving pocket for the first sterile barrier. The planar membrane sections form the receiving space around the first sterile barrier / receiving pocket. The air pockets are sealed / welded together to create the second sterile barrier around the first sterile barrier / receiving pocket. The second sterile barrier, along with the first sterile barrier, is placed in the outer protective packaging.

[0038] The disclosed method has the following advantages. The cushioning for the first sterile barrier is integrated into the second sterile barrier. Therefore, no additional bubble wrap or similar cushioning material needs to be included in the outer protective packaging. Furthermore, the method provides a double sterile barrier very simply and cost-effectively.

[0039] It can also be advantageous to create the second sterile barrier by sterilely welding the first sterile barrier inside the wider pocket of the second sterile barrier, and then folding the air pockets or air cushions of the second sterile barrier over the wider pocket. This simplifies the production of both the air pockets and the sterile receiving pocket.

[0040] The process can further include the following steps: The medical product is placed on a first film. A second film is placed on top of the first film containing the medical product. Then, both films are vacuum-sealed / welded on both sides of the medical product. Sealing the medical product between the films creates a sterile barrier. The product cannot move, or can only move minimally, within the films. This prevents the abrasion of particles due to friction.

[0041] Furthermore, the following steps can be carried out in the disclosed procedure for producing the second sterile barrier: Deep drawing of a first outer membrane to form the air pockets, which lie side by side and open in the same direction; sealing the two adjacent air pockets at their respective openings with a second inner membrane to form adjacent air pockets with one convex and one flat side; after insertion of the first sterile barrier, folding over the air pockets so that the air pockets are substantially aligned and the flat sides lie against each other, forming a receiving space for the first sterile barrier; and sealing the adjacent air pockets together.

[0042] The first membrane / film is deep-drawn to create open pockets / concave bulges. These open pockets are then closed off by the second membrane / film. The two membranes are sealed together. The second sterile barrier now consists of the concave bulged membrane and the planar membrane, which together form the air pockets. The first sterile barrier is placed on the planar membrane of the second sterile barrier. One of the air pockets is then folded over the folded edge. The air pockets are folded in such a way that they are essentially aligned and the planar sides lie flat against each other. The planar sides form the receiving space for the first sterile barrier. The elastic, planar membrane sections adapt to the shape of the first sterile barrier. This process provides a simple and cost-effective way to create a second sterile barrier with integrated air pockets.

[0043] The present disclosure further relates to a system comprising a medical sterile packaging according to one of the foregoing aspects and a medical product sterilely packaged within the medical sterile packaging. The at least two air pockets of the second sterile barrier are folded around the medical product such that a planar membrane of the second sterile barrier faces the medical product and the receiving space for the first sterile barrier is formed in the planar membrane. The elastic, planar membrane assumes the shape of the first sterile barrier and completely encloses it. This ensures that the first sterile barrier cannot move within the second sterile barrier and is also stored sterilely within the second sterile barrier. The other convex membrane is rigid and cannot conform to the shape of the first sterile barrier.

[0044] According to a further optional feature of the disclosure, the extent of the planar membrane is larger than the medical product. The receiving space of the planar membrane completely or nearly completely surrounds the medical product. Since the planar membrane segment encompassing the first sterile barrier is larger than the medical product and thus also larger than the first sterile barrier containing the medical product, the planar membrane segment can completely encompass / surround the first sterile barrier. Brief description of the characters

[0045] Fig. 1 shows a longitudinal section through a sterile packaging according to a first embodiment of the present disclosure with a first sterile barrier and a second sterile barrier; Fig. 2 shows a longitudinal section through the first sterile barrier containing a medical product; Fig. 3 shows a longitudinal section through the second sterile barrier; Fig. 4 shows a flowchart of a process for manufacturing the sterile packaging according to the present disclosure; Fig. 5 shows the second sterile barrier during manufacturing according to the disclosed process; and Fig. 6 shows the second sterile barrier in its finished state; Fig. 7 shows a sterile packaging according to a second embodiment of the present disclosure; and Fig. 8 shows a sterile packaging according to a third embodiment of the present disclosure. Detailed description of the figures

[0046] Fig. 1 Figure 1 shows a longitudinal section through a sterile packaging 1. The sterile packaging 1 has a protective packaging 2, which is preferably a cardboard box. The protective packaging 2 is approximately rectangular. Two sterile barriers are arranged inside the protective packaging 2. A first sterile barrier 4 is arranged sterilely within a second sterile barrier 6. A medical product 8 is sealed or welded inside the first sterile barrier 4. The second sterile barrier 6 surrounds the first sterile barrier 4 and is in contact with the protective packaging 2 on its outer surface. That is, the first sterile barrier 4 is completely enclosed by the second sterile barrier 6. The second sterile barrier 6 has two elongated air pockets 10. Each of the two air pockets 10 fills approximately half of the volume of the protective packaging 2. Thus, the two air pockets 10 divide the protective packaging 2 into two halves.The first sterile barrier 4 is positioned between the two air pockets 10. The two air pockets 10 are welded together on one side. On the other side, each of the two air pockets 10 has a weld tab 12. The two weld tabs 12 are welded together. Thus, the two air pockets 10 completely surround the first sterile barrier 4.

[0047] The two air pockets 10 cushion the first sterile barrier 4. This means that the two air pockets 10 protect the sterile barrier 4 from shocks. Additionally, the two air pockets 10 stabilize the protective packaging 2. The sealed welding tabs 12 ensure that the first sterile barrier 4 is stored sterile within the second sterile barrier 6.

[0048] Fig. 2 Figure 1 shows a longitudinal section through the first sterile barrier 4. The first sterile barrier 4 has two films: a bottom film 14 and an top film 16. The medical product 8 rests on the bottom film 14. The top film 16 is placed on the bottom film 14 with the medical product 8 and vacuum-sealed to the bottom film. The bottom film 14 and the top film 16 are sealed together on both sides of the medical product 8. This creates two weld points / seals 18.

[0049] Due to the vacuum sealing of the medical product 8 in the lower film 14 and the upper film 16, even under heavy transport stress of the sterile packaging 1, no or only minimal relative movement occurs between the medical product 8 and the two films 14, 16. This prevents or at least reduces the formation of particles through abrasion. The first sterile barrier 4 therefore serves as both particle and abrasion protection.

[0050] Fig. 3 Figure 1 shows a longitudinal section through the second sterile barrier 6. The first sterile barrier 4 is embedded between the two air pockets 10 of the second sterile barrier 6. The second sterile barrier 6 is a film, or is made of a film, which is a double membrane 19. The double membrane 19 has a first (outer) membrane 20 and a second (inner) membrane 22. The (outer) membrane 20 is in contact with the protective packaging 2 and is rigid. That is, the (outer) membrane 20 is not elastic or easily deformable. The (inner) membrane 22 is in contact with the first sterile barrier 4 and is elastic. That is, the first sterile barrier 4 sinks into the (inner) membrane 22, the membrane 22 adapts to the shape of the first sterile barrier 4 and (almost) completely encloses it. The (inner) membrane 22 forms a receiving space for the first sterile barrier 4. The two air pockets 10 are each hermetically sealed.The two welding tabs 12 of the two air pockets 10 are welded / sealed together, thereby forming a common welding tab of the second sterile barrier 6. The two welding tabs 12 are welded / sealed together by a seal 24.

[0051] Fig. 4 Figure 1 shows a flowchart of a process for manufacturing sterile packaging 1. In a first step S1, the first sterile barrier 4 is produced by sealing the medical product 8 between two films 14 and 16. The medical product 8 is placed on the lower film 14, covered with the upper film 16, and the two films 14 and 16 are vacuum-sealed. In a further step S2, two pockets 26 are formed in the rigid (outer) membrane 20 of the second sterile barrier 6 by deep drawing. The pockets 26 are adjacent and both open in the same direction. The two adjacent pockets 26 are hermetically sealed with the elastic (inner) membrane 22. The elastic (inner) membrane 22 is sealed by three seals 28, one outside the pockets 26 and one between the pockets 26.By sealing the two membranes 20, 22, the two air pockets 10 with the welding tabs 12 are formed. A fold-over edge 30 is positioned between the adjacent air pockets 10. In a further step S3, the first sterile barrier 4 is placed onto the elastic (inner) membrane 22 of one of the air pockets 10. The elastic (inner) membrane 22 yields and adapts to the shape of the first sterile barrier 4. The air pocket 10 on which the first sterile barrier 4 is not located is folded over the fold-over edge 30 in a further step S4, with the fold-over edge 30 forming the seal between the two air pockets 10. One of the air pockets 10 is folded over in such a way that an upper air pocket rests on the lower air pocket, the elastic (inner) membrane sections of the air pockets 10 touch and surround the first sterile barrier 4.The elastic (inner) membrane 22 forms the receiving space for the first sterile barrier 4. The two sealing tabs 12 are welded / sealed together in step S5. In a final step S6, the folded and sealed second sterile barrier 6, together with the first sterile barrier 4, is inserted into the protective packaging 2 and the protective packaging 2 is closed.

[0052] Fig. 5 Figure 1 shows the double membrane 19 of the second sterile barrier 6 after step S2. The two pockets 26 of the lower film 20 are formed. The elastic (inner) membrane 22 is welded to the openings of the pockets 26 to form the air pockets 10. Three weld points / seals 28 are formed for this purpose. The fold-over or folding edge 30 is formed between the two pockets 26.

[0053] Fig. 6 Figure 1 shows the double membrane 19 of the second sterile barrier 6 after manufacture. The two pockets 26 are folded over each other and the two sealing tabs 12 are welded together. The second sterile barrier 6 therefore has the weld point / seal 24.

[0054] Fig. 7 Figure 1 shows a sterile packaging 1 according to a second embodiment in an unfolded state. The sterile packaging 1 is therefore an integral component consisting of the second sterile barrier 6 with the two (elongated / rectangular) air pockets 10 and an additional receiving pocket 32 ​​for receiving a medical product, which is in turn packaged in the first sterile barrier. In this example, the two air pockets 10 are positioned directly next to each other and separated from each other by the (one) folding or creasing edge 30. The second sterile barrier 6 has the additional pocket 32, which is prepared and designed to receive the first sterile barrier 4 and thus the product packaged therein. The additional pocket 32 ​​is separated from the one air pocket 10, which is positioned directly next to the pocket 32, by another folding or creasing edge 30.The medical product 8 is placed in the pocket 32 ​​and is preferably vacuum-sealed within it. The air pockets 10 are folded over the pocket 32 ​​with the first sterile barrier 4 in such a way that an air pocket 10 rests against each side of the pocket 32. The air pockets 10 are partially compressible and form the receiving space for the pocket 32 ​​with the first sterile barrier 4 between them. The folded edges 30, which separate the two air pockets 10 and the further pocket 32, can be formed as a linear and / or spot weld. The linear weld can extend over the entire edge length or can be interrupted. If the weld is interrupted, linear, or spot, the air pockets can be in (fluid) contact with each other.The folding or folding edges 30 can also consist of several parallel welds.

[0055] The air pocket 10, positioned directly next to the bag 32, is first folded to one side of the bag 32. Then, the other air pocket 10 is folded over again to lie against the opposite side of the bag 32. This ensures that the bag 32 is surrounded and protected by the air pockets on both sides.

[0056] Fig. 8 Figure 1 shows a sterile packaging 1 according to a third embodiment in an unfolded state. In this embodiment, the two air pockets 10 are positioned on two opposite sides of the pocket 32 ​​containing the first sterile barrier 4. The pocket 32 ​​is thus arranged between the two air pockets 10. The pocket 32 ​​is separated from the air pockets by the fold-over edge 30. The pocket 32 ​​has a flap 34 for sealing the pocket 32 ​​after the first sterile barrier 4 containing the medical product 8 has been inserted. The two air pockets are each folded over at the fold-over edge 30 such that one air pocket rests against each side of the pocket 32.

[0057] This means that the bag and the medical product 8 lie in the bag in the receiving space between the air pockets 10 and are protected from (at least) two sides. Bezugszeichenliste

[0058] 1 Sterile packaging 2 Outer protective packaging 4 First sterile barrier 6 Second sterile barrier 8 Medical product 10 Air pocket 18 Seal 19 Double membrane 20 (Outer) membrane 22 (Inner) membrane 24 Seal 28 Seal 30 Fold-over or folding edge 32 Additional pocket 34 Flap

Claims

1. A sterile medical packaging (1) for packaging a medical product (8), comprising: - a first sterile barrier (4) prepared and configured to receive the medical product (8) in a heat-sealed / sealed manner, - a second sterile barrier (6) prepared and configured to form a receiving space for receiving the first sterile barrier (4) in a heat-sealed / sealed manner, and - an outer protective packaging (2) prepared and configured to receive the first sterile barrier (4) and the second sterile barrier (6), wherein the second sterile barrier (6) comprises or is a double membrane (19) that forms at least two air pockets (10), which are separated from each other by a predefined fold-down or folding edge (30) in the double membrane (19), whereby, in the folded-down state of the double membrane (19) along the fold-down or folding edge (30), the two air pockets (10) come to lie in alignment with each other in such a way that the receiving space can be created between them.

2. The sterile medical packaging (1) according to claim 1, characterized in that the double membrane has an outer membrane (20) that bulges out concavely, and an inner membrane (22) of the double membrane (19) remains planar.

3. The sterile medical packaging (1) according to claim 1 or 2, characterized in that when the air pockets (10) are folded down, the planar membrane (22) comes to lie in sections against each other essentially flat.

4. The sterile medical packaging (1) according to claim 2 or 3, characterized in that the heat-sealable / sealable receiving space can be created between the planar membrane sections (22), which lie flat against each other, in the area of the aligned air pockets (10), preferably by plastic or elastic deformation of the planar membrane sections (22) which lie flat against each other.

5. The sterile medical packaging (1) according to one of the claims 1 to 4, characterized in that the second sterile barrier (6) has exactly two air pockets (10).

6. The sterile medical package (1) according to one of claims 1 to 5, characterized in that the first convex membrane (20) of the second sterile barrier (6) is made of a rigid material and the second planar membrane (22) is elastic.

7. The sterile packaging (1) according to one of claims 1 to 6, characterized in that the first sterile barrier (4) comprises two films (14, 16) and is prepared and configured to heat-seal / seal the medical product (8) between the two films (14, 16) such that relative movement between the films (14, 16) and the medical product (8) is reduced.

8. The sterile medical packaging (1) according to one of claims 1 to 7, characterized by several sealings, wherein a first and a second sealing (18) seal the first sterile barrier (4), a third, a fourth and a fifth sealing (28) each seal the double membrane (19) next to the air pockets (10) of the second sterile barrier (6), and a sixth sealing (24) seals the two air pockets (10) which lie on top of each other together.

9. The sterile medical packaging (1) according to one of claims 1 to 8, characterized in that the second sterile barrier (6) has two air pockets (10), which are separated from each other by predefined folding edges (30) and can be folded down in such a way that an additional pocket (32) for receiving the first sterile barrier (4) is positioned between the air pockets (10).

10. The sterile medical packaging (1) according to claim 9, characterized in that the two air pockets (10) are each arranged on opposite sides of the additional pocket (32) with the first sterile barrier (4) located therein.

11. The sterile medical packaging (1) according to claim 9, characterized in that the two air pockets (10) are arranged on the same side of the additional pocket (32) with the first sterile barrier (4) located therein.

12. The sterile medical packaging (1) according to one of the claims 9 to 11, characterized in that the air pockets (10) are folded down on the folding edges (30) in such a way that the additional pocket (32) is surrounded by the air pockets (10) on at least two sides.

13. The sterile medical packaging (1) according to one of the claims 1 to 12, characterized in that the folding edge (30) connects the two membranes (20, 22) of the double membrane (19) and can be manufactured in particular by a point-shaped or line-shaped weld seam.

14. A system comprising a sterile medical packaging (1) according to one of claims 1 to 13 and a medical product (8) that is packaged in a sterile manner in the sterile medical packaging (1), characterized in that the at least two air pockets (10) of the second sterile barrier (6) are folded down around the medical product (8) such that the planar membrane (22) of the double membrane (19) of the second sterile barrier (6) faces toward of the medical product (8) and the receiving space for receiving of the first sterile barrier (4) is configured in the planar membrane (22).

15. The system according to claim 14, characterized in that the extent of the planar membrane (22) is greater than that of the medicinal product (8), and the receiving space completely or almost completely encloses the medicinal product (8).