Sterile packaging with attenuation function

Abstract

The present disclosure relates to a medical sterile package (1) for packaging a medical product (8). The package comprises a first sterile barrier (4) prepared and designed to receive the medical product (8) in a heat-sealed or sealed state, a second sterile barrier (6) prepared and designed to form a receiving space (23) for receiving the first sterile barrier (4) in a heat-sealed or sealed state, and an outer protective wrapper (2) prepared and designed to receive the first sterile barrier (4) and the second sterile barrier (6). The second sterile barrier (6) is a film (19) that forms at least two air pockets (10). The at least two air pockets (10) are separated from each other by a predetermined fold or bend edge (30). The air pockets are positioned so as to overlap each other when the film (19) is folded along the fold or bend edge (30) such that a receiving space (23) may be formed between the two air pockets.

Description

[Technical field]

[0001] The present disclosure relates to a sterile packaging for a medical product according to the preamble of claim 1. [Background technology]

[0002] Medical products must be packaged in a suitable manner to maintain their sterility and protect them from damage during transport and / or storage. In recent years, for this purpose, sterile packaging has been established which has at least two sterility barriers, preferably made of plastic materials and / or plastic films, and a further outer casing, for example made of cardboard material.

[0003] It is known to store medical products such as implants, instruments, accessories (especially tubes, containers, etc.), syringes and similar medical supplies in sterile packaging, which consists of an inner sterile barrier immediately surrounding the medical product, an outer sterile barrier supporting the inner sterile barrier, and an outer packaging (outer packaging) containing the outer sterile barrier.

[0004] Often, at least one of the sterile barriers is further made of a puncture-resistant fabric to prevent the medical product from escaping. Often, a sensor element is also provided within each sterile barrier, which indicates the ingress of air and thus the medical product contained therein is no longer sterile.

[0005] It is also known that shock-absorbing packaging materials such as plastic films generally form bubble-like or tubular compartments / pockets and trap air in them, forming multiple individual / independent air cushions uniformly distributed over the entire surface of the plastic film. Their role is to protect the packaged product from external influences such as vibration and impact. For example, by overlapping two plastic films, independent air pockets can be formed at appropriate places.

[0006] Alternatively, it is known to provide an outer casing made of a multi-layer corrugated material with two parallel cover plates and a corrugated intermediate plate, which deforms when an external force is applied to it, providing a shock absorbing effect.

[0007] The above-mentioned packaging materials can ensure both sterility and impact resistance, but the latter property (impact resistance) in particular poses the following problems, particularly in the medical field.

[0008] Shock-absorbing cardboard boxes need to be stored in a dry place to maintain their shape, especially the shape of the shock-absorbing interlayer. In addition, such materials are generally inelastic, i.e., they will undergo plastic deformation under external forces and therefore lose their inherent damping properties.

[0009] Impact-absorbing plastic films are generally pre-made with standardized sizes and spacing of cushioning pockets. In undesirable cases, the packaged product may partially protrude between the cushioning pockets, resulting in unprotected and exposed product portions. Therefore, such products are often wrapped with several layers of impact-absorbing plastic films to cushion (protect from impact) any product portions that may protrude. However, this makes the overall packaging layers quite thick. Summary of the Invention

[0010] In view of the prior art discussed above, one objective of the present disclosure is to provide a sterile medical package for medical products that provides adequate protection against external forces while ensuring sufficient sterility of the packaged product.

[0011] This object is achieved by a sterile medical packaging having the features of claim 1.

[0012] The present disclosure relates to a sterile medical package for packaging a medical product, as described above. The sterile medical package comprises a first sterile barrier, which is prepared and configured to form a first receiving space for receiving the medical product, preferably in a vacuumed, heat-sealed or sealed state, a second sterile barrier, which is prepared and configured to form a second receiving space for receiving the first sterile barrier, and an outer protective packaging, which is prepared and configured to receive the first and second sterile barriers. According to the present disclosure, the second sterile barrier comprises a film or double membrane forming at least two air pockets. The two air pockets are separated from each other by a predetermined folding or bending edge. Thereby, when the double membrane or film is folded along the folding or bending edge, the two air pockets are positioned so as to overlap each other, and a second receiving space can be formed between the two air pockets.

[0013] In other words, in the present disclosure, at least one of the at least two sterility barriers comprises or is a double-membrane film. One membrane of the film forms at least two air pockets that bulge only on one side of the film, while the other membrane remains substantially planar. The film further has a predetermined folding or bend edge extending between the two air pockets. In a state where the film is folded along the predetermined folding or bend edge, the air pockets come into contact in a substantially overlapping (aligned) state, and the planar membranes come into partial contact with each other in a substantially planar state. This allows a heat seal or sealable receiving space to be formed between the planar membrane parts that are positioned flat against each other in the overlapping air pocket area by plastic or elastic deformation of the planar membrane parts that are preferably positioned flat against each other.

[0014] In further words, the sterile package comprises a first sterile barrier, a second sterile barrier, and an outer protective package. The second sterile barrier is a two-layer film. Air is sealed between the two films, which creates an air pocket in the film. The film air pocket does not necessarily have to be symmetrically configured, but may have a convex / concave side and a flat side. The air pocket is folded at the folding edges such that the flat sides are butted against or flush with each other. A receiving space is configured between the flat sides / membrane portions of the folded air pocket to receive the first sterile barrier.

[0015] Thus, the essence of the present disclosure is that at least two air pockets are folded around a first sterility barrier such that the air pockets are arranged one above the other and (completely) surround / enclose the first sterility barrier, thereby (completely) containing the stored product between the two air pockets, and thus a receiving space for the first sterility barrier is formed at the contact surface of the two air pockets.

[0016] In this context, substantially planar means that the membrane is flat. However, slight convex bulges and similarly slight concave depressions may occur in an elastic membrane (stretchable membrane) due to, for example, pressure fluctuations in air pockets. Such slight deviations from a planar membrane are still considered to be substantially planar within the meaning of this disclosure.

[0017] In particular, the folding or bending edge may form a fold line separating two adjacent gas cushions, in particular air pockets / air cushions. In this case, the folding or bending edge in particular connects two membranes of a double membrane. The folding or bending edge may be formed by spot welding or at least partially linear weld seams. If the folding or bending edge is realized by spot welding, the adjacent air cushions can be partially connected to each other, so that the air in the individual cushions communicates. The weld seam may also extend over the entire length of the folding or bending edge, so that the individual air cushions are independent of each other. Furthermore, the linear weld seam may be interrupted so that the individual air cushions can be connected to each other. Several (e.g. two) weld seams or lines may be arranged adjacent to each other, in particular parallel, forming the folding or bending edge between the air cushions.

[0018] The present disclosure has the following advantages:

[0019] Since the sterile package includes two sterility barriers, the medical product within the sterile package is protected by double sterility.

[0020] The medical product is protected from external influences such as shock and vibration by the air pocket.

[0021] Because the air pocket is integrated into the sterile barrier, there is no need to incorporate an additional air cushion or other cushioning means into the outer protective packaging, thus eliminating the need for additional parts and packaging steps.

[0022] Finally, the two air pockets form a gap in the middle when the film is folded, into which the product, already shrink-wrapped with the first sterility barrier, can be fully inserted (due to the elastic deformation of the second sterility barrier). The product is then completely surrounded by a (single-layer) air cushion. This ensures optimal protection of the product while minimizing the amount of packaging material required.

[0023] Preferably, the second sterile barrier has two air pockets. These air pockets are separated from each other by one or more predetermined folding or bend edges and may be folded so that an additional pocket for receiving the first sterile barrier is located between the air pockets. The first sterile barrier with the medical product is introduced into the additional pocket of the second sterile barrier and is heat sealed there, preferably under vacuum. The second sterile barrier may have two air pockets in addition to the additional pocket. These air pockets are separated from the additional pocket by at least one or more predetermined folding or bend edges. It is very easy to manufacture this structure.

[0024] In other words, the second sterile barrier has two parts configured as air pockets and one configured as an additional receiving pocket, which are joined together into a single piece via folding or creasing edges. The additional receiving pocket serves to receive the first sterile barrier and thus the medical product located therein. Thus, almost inevitably, the relative position of the medical product with respect to the two air pockets is determined when the medical product is placed in the receiving pocket together with the first sterile barrier surrounding it, possibly fixed by applying a vacuum to the receiving pocket. When the air pockets are folded over along the folding or creasing edges, the medical product automatically rests between the air pockets in the correct orientation.

[0025] In an advantageous configuration, the air pocket may be folded around the additional (receiving) pocket such that the additional pocket is surrounded by the air pocket on at least two sides. The air pocket is at least partially compressible, such that when the additional pocket containing the first sterility barrier is placed in contact between the two air pockets, the air pocket is (partially) compressed to form a receiving space for the additional pocket and the medical product (including its first sterility barrier) within the additional pocket. As a result, the medical product is stored with the cushioning material and protected by the air pocket.

[0026] According to a further optional feature of the present disclosure, the two air pockets are each disposed opposite the additional pocket. That is, the air pockets are disposed on either side of the additional pocket and are connected to the additional (receiving) pocket via folding or bent edges in a single piece of material. Thus, the air pockets and the additional pockets are each spatially separated or spaced apart, like a hinge, by the folding or bent edges. In this configuration, each of the air pockets is folded (Z-shaped) at the folding or bent edges to the opposite side of the additional pocket. This causes the additional pocket to be surrounded by the air pocket.

[0027] Alternatively, the two air pockets may be located on the same side of the additional pocket with the first sterility barrier. That is, the air pockets may be located next to each other on one side of the additional pocket. The air pockets are separated from each other by a folding or crimping edge. The air pocket is also separated from the additional pocket by a folding or crimping edge. When folding an air pocket around the additional pocket, the air pocket adjacent to the additional pocket is folded first. The other air pocket is then folded on the opposite side of the additional pocket from the first air pocket.

[0028] According to a further optional feature of the present disclosure, the film of the second sterility barrier is made of a double membrane, one membrane bulging outwardly in a concave manner while the other membrane remains flat. In other words, the film consists of two films. The first film forms a concave pocket and the second film is flat and seals the pocket. The concave membrane side provides sufficient volume for the air in the air pocket. The flat membrane allows the flat membrane parts to lie as flat as possible against each other after folding.

[0029] According to a further optional feature of the present disclosure, when the film is folded, the planar membranes come to lie in sections against each other essentially flat. The planar membrane sections lying flat against each other form a receiving space for the first sterility barrier. As a result, the planar membrane surrounds the first sterility barrier as completely as possible. The second sterility barrier is formed by surrounding the first sterility barrier with a membrane and then sealing the planar membrane sections.

[0030] According to a further optional feature of the present disclosure, a heat sealable / sealable receiving space is formed between the planar membrane parts lying flat against each other in the area of ​​the overlapping air pockets. The receiving space is preferably formed by plastic or elastic deformation of the planar membrane parts lying flat against each other. The stretchable membrane (elastic membrane) is deformed to the shape of the first sterile barrier. The first sterile barrier is largely enclosed by said membrane taking the shape of the first sterile barrier. In this way, a good cushioning and sterile packaging with minimal movement is obtained.

[0031] According to a further optional feature of the present disclosure, the second sterility barrier is a film having a double membrane. The first convex membrane of the double membrane is made of a rigid material and the second planar membrane is elastic (has stretchability). The first membrane is relatively rigid and therefore deep-drawable. Air pockets are formed by deep-drawing. Furthermore, the rigid membrane acts as a puncture prevention membrane to prevent a sharp instrument from piercing the sterile packaging. The second membrane is stretchable and therefore can take the shape of the first sterility barrier and can largely surround the first sterility barrier.

[0032] According to a further optional feature of the present disclosure, the first sterility barrier comprises two films and is prepared and configured to heat seal / seal the medical product between the two films such that the relative movement between the films and the medical product is reduced. That is, the medical product is tightly heat sealed between the two films and cannot move within the films. The reduced relative movement between the film and the medical product eliminates or at least reduces particle formation due to friction between the film and the medical product. Particles can contaminate the sterile medical product. In the worst case, this can lead to repeated cleaning and sterilization. Thus, the tightly heat sealed film provides a sterility barrier while effectively protecting the medical product against particles and abrasion.

[0033] According to a further optional feature of the present disclosure, the first sterility barrier is stored in a sterile condition within a second sterility barrier. To achieve a double sterility barrier or double sterility function, the first sterility barrier must be placed in an additional sterile package / second sterility barrier. This is the second sterility barrier. The second sterility barrier encases the first sterility barrier and is heat sealed, so that it functions as a sterility barrier.

[0034] According to a further optional feature of the present disclosure, the sterile package has a plurality of seals: a first and second seal seal the first sterility barrier, a third, fourth and fifth seal each seal the bilayer membrane next to the air pocket of the second sterility barrier, and a sixth seal seals together the two overlapping air pockets.

[0035] The first seal and the second seal seal the two films of the first sterile package on either side of the medical product. The three seals hold together the two membranes of the bilayer of the second sterile barrier. These two membranes may be two films that are heat sealed together by the seals. The three seals are attached to both outsides of the air pocket and between the air pockets. The remaining seal seals the two folded and abutting air pockets together to form a second sterile barrier around the first sterile barrier. Such seals ensure the sterility of the individual packaging layers or individual barriers.

[0036] According to a further optional feature of the present disclosure, the second sterility barrier has exactly two air pockets, which allows exactly one medical product to be stored in a cushioned state between the two air pockets. Of course, it is also conceivable that the second sterility barrier has multiple air pockets, which allows multiple medical products to be stored in a cushioned state.

[0037] The object of the present disclosure may also be solved by a method for producing a sterile package according to one of the above aspects. The method according to the present disclosure comprises the following steps: A first sterile barrier is produced by sealing two films (around the medical product). A second sterile barrier is produced, for example, by deep drawing of an air pocket and subsequent sealing of the air pocket. The first sterile barrier is placed on one of the planar membrane parts of the second sterile barrier or inserted into a receiving pocket between two air pockets. The receiving pockets are joined together with the two air pockets to form a single member and are spatially separated from each other via fold lines. After placing / inserting the first sterile barrier, one of the air pockets is folded in such a way that they surround the first sterile barrier or the receiving pocket for the first sterile barrier. The planar membrane parts form a receiving space around the first sterile barrier / receiving pocket. The air pockets are sealed / heat sealed to form a second sterile barrier around the first sterile barrier / receiving pocket. The second sterility barrier is placed in an outer protective packaging along with the first sterility barrier.

[0038] The method according to the present disclosure has the following advantages: the cushioning material for the first sterility barrier is integrated with the second sterility barrier. Therefore, there is no need to place an additional air cushion film or similar cushioning means on the outer protective packaging. Moreover, this method provides a double sterility barrier in a very simple and low-cost manner.

[0039] It may also be advantageous to manufacture the second sterile barrier by aseptically heat sealing the first sterile barrier to a larger pocket of the second sterile barrier and then folding the air pocket or air cushion of the second sterile barrier around the additional pocket. Thus, the air pocket and the sterile receiving pocket are easy to manufacture.

[0040] The method may further include the steps of: placing a medical product on the first film; placing a second film on the first film with the medical product; and then vacuum / heat sealing the two films on either side of the medical product. By heat sealing the medical product between the two films, a sterile barrier is created. The medical product cannot move or only has minimal movement within the film, which prevents wear of particles due to friction.

[0041] Further, in a method according to the present disclosure for producing a second sterility barrier, the following steps may be carried out. deep drawing the first outer membrane to form a plurality of air pockets adjacent to each other and opening in the same direction; a second, inner membrane sealing the two adjacent air pockets at their respective openings to form adjacent air pockets having a curved side and a flat side; folding the air pockets around the first sterile barrier so that the air pockets substantially overlap and the planar sides of the air pockets are flat against each other, thereby forming a receiving space for receiving the first sterile barrier; Adjacent air pockets are sealed together.

[0042] The first membrane / film is deep drawn to create open pockets / concave bulges. These open pockets are closed by the second membrane / film. To do so, the two membranes are sealed together. The second sterile barrier now has a concave bulge membrane and a flat membrane, which together form an air pocket. The first sterile barrier is placed on top of the flat membrane of the second sterile barrier. Then, one of the air pockets is folded over with a folded or bent edge. The air pockets are folded so that they substantially overlap and the flat sides of the air pockets are flat against each other. The flat sides of the air pockets form a receiving space for the first sterile barrier. To achieve this, the elastic flat membrane portion adapts to the shape of the first sterile barrier. This process allows to provide a second sterile barrier with an integrated air pocket in a simple and cost-effective way.

[0043] The present disclosure further relates to a system including a medical sterile packaging according to one of the above-mentioned aspects and a medical product packaged in the medical sterile packaging in a sterile state. At least two air pockets of the second sterile barrier are folded around the medical product with the flat membrane of the second sterile barrier facing the medical product, forming a receiving space in the flat membrane for receiving the first sterile barrier. The elastic flat membrane takes the shape of the first sterile barrier and completely covers the first sterile barrier. This ensures that the first sterile barrier cannot move in the second sterile barrier and is stored in a sterile state in the second sterile barrier. The other convex membrane is rigid and cannot adapt to the shape of the first sterile barrier.

[0044] According to a further optional feature of the present disclosure, the area of ​​the planar membrane is larger than the area of ​​the medical product. The receiving space of the planar membrane completely or almost completely surrounds the medical product. The planar membrane portion covering the first sterile barrier is larger than the medical product and therefore larger than the first sterile barrier with the medical product, so that the planar membrane portion can completely cover the first sterile barrier. [Brief description of the drawings]

[0045] [Figure 1] FIG. 2 shows a longitudinal section through a sterile packaging according to a first embodiment of the present disclosure comprising a first sterility barrier and a second sterility barrier. [Diagram 2] FIG. 2 shows a longitudinal section of a first sterile barrier together with a medical device. [Diagram 3] FIG. 2 shows a longitudinal section of the second sterility barrier. [Figure 4] FIG. 1 illustrates a flow chart of a method for producing a sterile package according to the present disclosure. [Diagram 5] FIG. 1 illustrates a second sterility barrier during manufacture according to a method according to the present disclosure. [Figure 6] FIG. 2 shows the second sterility barrier in its completed state. [Figure 7] FIG. 2 shows a sterile package according to a second embodiment of the present disclosure. [Figure 8] FIG. 13 shows a sterile packaging according to a third embodiment of the present disclosure. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0046] FIG. 1 shows a longitudinal section of a sterile packaging 1. The sterile packaging 1 comprises a protective packaging 2. The protective packaging 2 is preferably a cardboard box. The protective packaging 2 is approximately rectangular. Two sterile barriers are arranged in the protective packaging 2. The first sterile barrier 4 is arranged in a sterile state in the second sterile barrier 6. The medical product 8 is sealed or heat sealed to the inside of the first sterile barrier 4. The second sterile barrier 6 surrounds the first sterile barrier 4. The outer surface of the second sterile barrier 6 is in contact with the protective packaging 2. That is, the first sterile barrier 4 is completely surrounded by the second sterile barrier 6. The second sterile barrier 6 has two elongated air pockets 10. One of the two air pockets 10 both fills approximately half of the volume of the protective packaging 2. The two air pockets 10 therefore divide the protective packaging 2 in half. The first sterility barrier 4 is supported between two air pockets 10. The two air pockets 10 are connected by a heat seal on one side. On the other side, the two air pockets 10 each have a heat sealed corner 12. The two heat sealed corners 12 are connected by a heat seal. Thus, the two air pockets 10 completely surround the first sterility barrier 4.

[0047] The two air pockets 10 cushion and support the first sterility barrier 4, i.e., they protect the sterility barrier 4 from vibration. Furthermore, the two air pockets 10 stabilize the protective packaging 2. Due to the sealed heat-sealed corners 12, the first sterility barrier 4 is kept sterile within the second sterility barrier 6.

[0048] Figure 2 shows a longitudinal section of the first sterility barrier 4. The first sterility barrier 4 comprises two films, a bottom film 14 and a top film 16. The medical product 8 is on top of the bottom film 14. The top film 16 is placed on top of the bottom film 14 with the medical product 8 and a vacuum is applied with the bottom film connected by a heat seal. This results in the bottom film 14 and top film 16 being connected by a heat seal on either side of the medical product 8. As a result, two seals 18 are formed.

[0049] Due to the medical product 8 being vacuum sealed within the lower film 14 and the upper film 16, there is no or only slight relative movement between the medical product 8 and the two films 14, 16, even when the sterile package 1 is subjected to heavy transport loads. This makes it possible to prevent or at least reduce the formation of particles due to abrasion. In this way, the first sterility barrier 4 simultaneously provides protection against particles and abrasion.

[0050] FIG. 3 shows a longitudinal section of the second sterile barrier 6. The first sterile barrier 4 is embedded between two air pockets 10 of the second sterile barrier 6. The second sterile barrier 6 is or consists of a film that 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 to say, the (outer) membrane 20 is inelastic and does not easily deform. The (inner) membrane 22 is in contact with the first sterile barrier 4 and is elastic. This allows the first sterile barrier 4 to sink into the (inner) membrane 22, which adapts to the shape of the first sterile barrier 4 and (almost) completely surrounds the first sterile barrier 4. The (inner) membrane 22 forms a receiving space 23 for the first sterile barrier 4. The two air pockets 10 are each hermetically sealed. The two heat sealed corners 12 of the two air pockets 10 are heat sealed / sealed to each other, thereby forming a common heat sealed corner of the second sterility barrier 6. The two heat sealed corners 12 are heat sealed / sealed to each other at seal 24.

[0051] FIG. 4 shows a flow chart of the process for producing the sterile package 1. In a first step S1, the first sterile barrier 4 is created by sealing the medical product 8 between two films 14, 16. In this process, the medical product 8 is placed on the bottom film 14 and covered with the top film 16, and the two films 14, 16 are heat sealed under vacuum. In a next step S2, two pockets 26 are formed in the rigid (outer) membrane 20 of the second sterile barrier 6 by deep drawing. These pockets 26 are adjacent to each other and both open in the same direction. The two adjacent pockets 26 are hermetically sealed with an elastic (inner) membrane 22. The elastic (inner) membrane 22 is sealed with three seals 28, one on the outside of the two pockets 26 and one between the pockets 26. By sealing the two membranes 20, 22, the two air pockets 10 are configured with heat sealed corners 12. Between adjacent air pockets 10, a fold or bend edge 30 is located. In a further step S3, the first sterile barrier 4 is placed on 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. In a further step S4, the air pocket 10 on which the first sterile barrier 4 is not placed is folded at the fold or bend edge 30. The seal between the two air pockets 10 is the fold or bend edge 30. One of the air pockets 10 is folded such that the upper air pocket rests on the lower air pocket. The elastic (inner) membrane part of the air pocket 10 contacts and surrounds the first sterile barrier 4. The elastic (inner) membrane 22 forms a receiving space 23 for the first sterile barrier 4. In a step S5, the two heat seal corners 12 are heat sealed / sealed to each other. In a final step S6, the folded and sealed second sterility barrier 6 is placed together with the first sterility barrier 4 within the protective packaging 2 and the protective packaging 2 is sealed.

[0052] Figure 5 shows the bilayer 19 of the second sterility barrier 6 after step S2. Two pockets 26 of the lower film 20 are configured. The elastic (inner) membrane 22 is heat sealed over the openings of the pockets 26 to form the air pockets 10. Three weld spots / seals 28 are configured for this purpose. Between the two pockets 26 a fold or bend edge 30 is configured.

[0053] Figure 6 shows the bilayer 19 of the second sterility barrier 6 after manufacture. In this case, the two pockets 26 are folded over each other and the two heat seal corners 12 are heat sealed together. The second sterility barrier 6 therefore has a weld / seal 24.

[0054] FIG. 7 shows a sterile packaging 1 according to a second embodiment in an unfolded state. The sterile packaging 1 is an integral component made up of a second sterile barrier 6 with two (elongated / rectangular) air pockets 10 and an additional receiving pocket 32 ​​for receiving a medical product. The medical product is likewise packaged in the first sterile barrier. In this example, the two air pockets 10 are located directly adjacent to each other and are separated from each other by a (single) fold or bend edge 30. The second sterile barrier 6 has an additional pocket 32. This additional pocket 32 ​​is prepared and configured to receive the first sterile barrier 4 and the product packaged therein. The additional pocket 32 ​​is separated from the first air pocket 10 by an additional fold or bend edge 30 located immediately next to the pocket 32. The medical product 8 is placed in the pocket 32 ​​and is preferably evacuated and heat sealed / sealed in this pocket. The air pockets 10 are folded / wrapped (continuously) around the pocket 32 ​​with the first sterility barrier 4 so that the air pockets 10 are in contact with each side of the pocket 32. The air pockets 10 are partially compressible and form between them a receiving space 23 for the pocket 32 ​​with the first sterility barrier 4. The folding or bent edge 30 separating the two air pockets 10 and the additional pocket 32 ​​may be configured as a linear and / or point-like welded seam. The linear welded seam may extend over the entire length of the edge or may be interrupted. If the welded seam is linear or point-like and interrupted, the air pockets may be in (fluid) communication with each other. The folding or bent edge 30 may be composed of a number of parallel welded seams.

[0055] The air pocket 10 immediately adjacent to the pocket 32 ​​is first folded onto one side of the pocket 32. The other air pocket 10 is then folded again to contact the opposite side of the pocket 32. As a result, the pocket 32 ​​is surrounded and protected by the air pockets on either side of it.

[0056] FIG. 8 shows a sterile packaging 1 according to a third embodiment in an unfolded state. In this embodiment, two air pockets 10 are located on either side of a pocket 32. A first sterility barrier 4 is placed in the pocket 32, i.e. the pocket 32 ​​is arranged between the two air pockets 10. The pocket 32 ​​is separated from these air pockets by a folding or bent edge 30. The pocket 32 ​​has a tab 34 for sealing the pocket 32 ​​after the first sterility barrier 4 with the medical product 8 is inserted. The two air pockets are each folded at the folding or bent edge 30, thereby contacting one air pocket on each side of the pocket 32. As a result, the pocket and the medical product 8 therein are located in a receiving space 23 between these air pockets 10 and are protected from (at least) two sides. [Explanation of symbols]

[0057] 1 Sterile packaging 2 Outer protective packaging 4. First Sterile Barrier 6 Secondary Sterile Barrier 8 Medical Products 10 Air Pocket 18 Seal part 19 Double membrane 20 (outer) membrane 22 (inner) membrane 23 Receptive Space 24 Seal part 28 Seal Part 30 Folded or bent edges 32 additional pockets 34 Tabs

Claims

1. A sterile medical package (1) for packaging a medical product (8), comprising: a first sterility barrier (4) prepared and configured to receive said medical product (8) in a heat sealed or sealed state; a second sterility barrier (6) arranged and configured to form a receiving space (23) for receiving said first sterility barrier (4) in a heat sealed or sealed state; an outer protective packaging (2) prepared and configured to receive said first sterility barrier (4) and said second sterility barrier (6); said second sterility barrier (6) comprises or is a bilayer (19) forming at least two air pockets (10); At least two of the air pockets (10) are separated from each other by a predetermined folding or bend edge (30) in the double membrane (19), whereby when the double membrane (19) is folded along the folding or bend edge (30), the two air pockets (10) are positioned so as to overlap each other such that the receiving space (23) can be formed between the two air pockets.

2. 2. The sterile medical package (1) of claim 1, wherein the bilayer has an outer membrane (20) that bulges concavely, and an inner membrane (22) of the bilayer (19) remains flat.

3. 3. The sterile medical package (1) according to claim 1 or 2, wherein when the air pockets (10) are folded, the planar membranes (22) lie partially opposite each other in a substantially flat state.

4. 4. The sterile medical packaging (1) according to claim 2 or 3, wherein in the area of ​​the overlapping air pockets (10), the heat-sealable or sealable receiving space (23) can be formed between the planar membrane portions (22) lying flat opposite each other, preferably by plastic or elastic deformation of the planar membrane portions (22) lying flat opposite each other.

5. 5. The sterile medical packaging (1) according to any one of claims 1 to 4, wherein the second sterility barrier (6) has exactly two said air pockets (10).

6. 6. The sterile medical packaging (1) according to any one of claims 1 to 5, wherein the first convex membrane (20) of the second sterility barrier (6) is made of a rigid material and the second flat membrane (22) is elastic.

7. 7. The sterile medical package (1) of any one of claims 1 to 6, wherein the first sterility barrier (4) comprises two films (14, 16) and is prepared and configured to heat seal or seal the medical product (8) between the two films (14, 16) so as to reduce relative movement between the films (14, 16) and the medical product (8).

8. 8. The sterile medical package (1) according to any one of claims 1 to 7, comprising a plurality of seals, wherein a first and a second seal (18) seal the first sterility barrier (4), a third, a fourth and a fifth seal (28) each seal the double membrane (19) adjacent the air pocket (10) of the second sterility barrier (6), and a sixth seal (24) seals together two overlapping air pockets (10).

9. 9. The sterile medical packaging (1) according to any one of claims 1 to 8, wherein the second sterility barrier (6) has two air pockets (10) separated from each other by a predetermined folding edge (30) and is foldable so that an additional pocket (32) for receiving the first sterility barrier (4) is located between the air pockets (10).

10. The sterile medical packaging (1) of claim 9, wherein the two air pockets (10) are arranged on either side of the additional pocket (32), and the first sterility barrier (4) is located within the additional pocket (32).

11. 10. The sterile medical packaging (1) of claim 9, wherein the two air pockets (10) are arranged on the same side of the additional pocket (32) and the first sterility barrier (4) is located within the additional pocket (32).

12. 12. The sterile medical packaging (1) according to any one of claims 9 to 11, wherein the air pocket (10) is folded at the folding edge (30) such that the additional pocket (32) is surrounded by the air pocket (10) on at least two sides.

13. The sterile medical packaging (1) according to any one of claims 1 to 12, wherein the folded edge (30) connects the two membranes (20, 22) of the double membrane (19) and may in particular be produced by a point-like or linear welded seam.

14. A method for treating a medical product comprising: a sterile medical package (1) according to any one of claims 1 to 13; and a medical product (8) packaged in the sterile medical package (1) under sterile conditions, The at least two air pockets (10) of the second sterile barrier (6) are folded around the medical product (8) such that a planar membrane (22) of the double membrane (19) of the second sterile barrier (6) faces the medical product (8), and a receiving space (23) for receiving the first sterile barrier (4) is configured in the planar membrane (22).

15. 15. The system according to claim 14, wherein the area of ​​the planar membrane (22) is greater than the area of ​​the medical product (8) and the receiving space (23) completely or almost completely surrounds the medical product (8).

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