Abstract
A medicinal sterile packaging for packaging a medicinal product includes a first sterile barrier designed to receive the medicinal product in a heat-sealed/sealed manner. A second sterile barrier forms a receiving space for receiving the first sterile barrier in a heat-sealed/sealed manner. An outer protective packaging receives the first sterile barrier and the second sterile barrier. The second sterile barrier is a film that forms at least two air pockets separated from one another in the film by a predefined fold-over or folding edge. When the film is folded over along the fold-over or folding edge, the two air pockets come to lie one on top of the other in alignment, such that the receiving space can be produced between them.
Claims
1.-15. (canceled)
16. A sterile medical packaging for packaging a medical product, the sterile medical packaging comprising: a first sterile barrier; a second sterile barrier; and an outer protective packaging, the first sterile barrier configured to receive the medical product in a sealed manner, the second sterile barrier configured to form a receiving space for receiving the first sterile barrier in a sealed manner, the outer protective packaging configured to receive the first sterile barrier and the second sterile barrier, the second sterile barrier comprising a double membrane forming at least two air pockets, the at least two air pockets being separated from each other by a predefined folding edge in the double membrane, the double membrane being foldable into a folded-down state along the predefined folding edge, and the at least two air pockets being aligned with each other in the folded-down state such that the receiving space is created between the at least two air pockets.
17. The sterile medical packaging according to claim 16, wherein: the double membrane comprises an inner membrane and an outer membrane, the outer membrane bulges out concavely, and the inner membrane is planar.
18. The sterile medical packaging according to claim 17, wherein the predefined folding edge connects the inner membrane and the outer membrane.
19. The sterile medical packaging according to claim 18, wherein the predefined folding edge is manufactured by a point-shaped or line-shaped weld seam.
20. The sterile medical packaging according to claim 17, wherein the outer membrane is made of a rigid material and the inner membrane is elastic.
21. The sterile medical packaging according to claim 17, wherein: the inner membrane comprises at least two inner membrane sections, the at least two inner membrane sections are aligned adjacent to each other in proximity to the at least two air pockets in the folded-down state, and the receiving space is positioned between the at least two inner membrane sections.
22. The sterile medical packaging according to claim 21, wherein the receiving space is formable by plastic or elastic deformation of the at least two inner membrane sections.
23. The sterile medical packaging according to claim 21, wherein the at least two inner membrane sections lie flat in sections against each other in the folded-down state.
24. The sterile medical packaging according to claim 21, wherein the at least two air pockets consists of exactly two air pockets.
25. The sterile medical packaging according to claim 16, wherein: the first sterile barrier comprises two films, and the first sterile barrier is configured to seal the medical product between the two films to limit movement of the medical product relative to the two films.
26. The sterile medical packaging according to claim 16, wherein: the sterile medical packaging comprises a first sealing, a second sealing, a third sealing, a fourth sealing, a fifth sealing, and a sixth sealing, the first sealing and the second sealing seal the first sterile barrier, the third sealing, the fourth sealing and the fifth sealing each seal the double membrane next to the at least two air pockets, and the sixth sealing seals the at least two air pockets.
27. The sterile medical packaging according to claim 16, wherein: the at least two air pockets consists of two air pockets, the two air pockets are separated from each other by predefined folding edges, and the two air pockets are foldable in such a way that an additional pocket for receiving the first sterile barrier is positioned between the two air pockets.
28. The sterile medical packaging according to claim 27, wherein the two air pockets are each arranged on opposite sides of the additional pocket, and the first sterile barrier is located in the additional pocket.
29. The sterile medical packaging according to claim 27, wherein the two air pockets are arranged on a same side of the additional pocket, and the first sterile barrier is located in the additional pocket.
30. The sterile medical packaging according to claim 27, wherein the two air pockets are folded down on the predefined folding edges in such a way that the additional pocket is surrounded by the two air pockets on at least two sides.
31. A system comprising: the sterile medical packaging according to claim 16; and a medical product that is packaged in a sterile manner in the sterile medical packaging, the at least two air pockets being folded down around the medical product such that a planar membrane of the double membrane faces toward the medical product and the receiving space is configured in the planar membrane.
32. The system according to claim 31, wherein the planar membrane extends beyond the medical product, and the receiving space completely encloses the medical product.
Description
BRIEF DESCRIPTION OF THE DRAWINGS
[0049] 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;
[0050] FIG. 2 shows a longitudinal section through the first sterile barrier with a medical device;
[0051] FIG. 3 shows a longitudinal section through the second sterile barrier;
[0052] FIG. 4 shows a flow chart of a method for producing the sterile packaging according to the disclosure;
[0053] FIG. 5 shows the second sterile barrier during manufacture according to the method according to the disclosure;
[0054] FIG. 6 shows the second sterile barrier in the finished state;
[0055] FIG. 7 shows a sterile packaging according to a second embodiment of the present disclosure; and
[0056] FIG. 8 shows a sterile packaging according to a third embodiment of the present disclosure.
DETAILED DESCRIPTION
[0057] FIG. 1 shows a longitudinal section through a sterile packaging 1. The sterile packaging 1 comprises a protective packaging 2, which is preferably a cardboard box. The protective packaging 2 is approximately rectangular. Two sterile barriers are arranged within the protective packaging 2. A first sterile barrier 4 is arranged in a sterile manner within a second sterile barrier 6. A medical product 8 is sealed or heat-sealed inside the first sterile barrier 4. The second sterile barrier 6 surrounds the first sterile barrier 4 and is in contact on its outer side with the protective packaging 2. I.e. 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. One of the two air pockets 10 in each case almost fills 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 supported between the two air pockets 10. The two air pockets 10 are connected by heat-sealing 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 heat-sealing. Thus, the two air pockets 10 completely surround the first sterile barrier 4.
[0058] The two air pockets 10 support the first sterile barrier 4 in a cushioning manner. This means that the two air pockets 10 protect the sterile barrier 4 from vibrations. In addition, the two air pockets 10 stabilize the protective packaging 2. Due to the sealed heat-sealed corner 12, the first sterile barrier 4 is stored in a sterile manner within the second sterile barrier 6.
[0059] FIG. 2 shows a longitudinal section through the first sterile barrier 4. The first sterile barrier 4 comprises two films, namely a lower film 14 and an upper film 16. The medical product 8 lies on the lower film 14. The upper film 16 is placed on the lower film 14 with the medical product 8 and vacuumized with the lower film connected by heat-sealing. The lower film 14 and the upper film 16 are thereby connected by heat-sealing on both sides of the medical product 8. This results in two sealings 18.
[0060] Due to the vacuum sealing of the medical product 8 in the lower film 14 and the upper film 16, there is no or only minimal relative movement between the medical product 8 and the two films 14, 16, even when the sterile packaging 1 is subject to heavy transport loads. This helps to prevent or at least reduce the formation of particles through abrasion. The first sterile barrier 4 thus provides simultaneous protection against particles and abrasion.
[0061] FIG. 3 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 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, the (outer) membrane 20 is not elastic or not readily deformable. The (inner) membrane 22 is in contact with the first sterile barrier 4 and is elastic. This means that 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 encloses it (almost) completely. 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 and thus form a common heat-sealed corner of the second sterile barrier 6. The two heat-sealed corners 12 are heat-sealed/sealed to each other with a seal 24.
[0062] FIG. 4 shows a flow chart of a process for manufacturing the 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, 16. In this process, the medical product 8 is placed on the lower film 14, covered with the upper film 16 and the two films 14, 16 are heat-sealed under vacuum. 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 to each other 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 sealings 28, once outside the pockets 26 and once between the pockets 26. By sealing the two membranes 20, 22, the two air pockets 10 are configured with the heat-sealed corners 12. A fold-down or folding edge 30 is positioned between the adjacent air pockets 10. 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. The air pocket 10 on which the first sterile barrier 4 is not located is folded down in a further step S4 around the fold-down or folding edge 30, wherein the sealing between the two air pockets 10 is the fold-down or folding edge 30. One of the air pockets 10 is folded down 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 23 for the first sterile barrier 4. The two heat-sealed corners 12 are heat-sealed/sealed to each other in step S5. The folded-down and sealed second sterile barrier 6 together with the first sterile barrier 4 is placed in the protective packaging 2 in a final step S6 and the protective packaging 2 is sealed.
[0063] FIG. 5 shows the double membrane 19 of the second sterile barrier 6 after step S2. The two pockets 26 of the lower film 20 are configured. The elastic (inner) membrane 22 is heat-sealed onto the openings of the pockets 26 to form the air pockets 10. The three weld spots/sealings 28 are configured for this purpose. The fold-down or folding edge 30 is configured between the two pockets 26.
[0064] FIG. 6 shows the double membrane 19 of the second sterile barrier 6 after manufacturing. In this case, the two pockets 26 are folded onto each other and the two heat-sealed corners 12 are heat-sealed to each other. The second sterile barrier 6 therefore has the weld point/seal 24.
[0065] FIG. 7 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 in turn is packed 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) fold-down or folding edge 30. The second sterile barrier 6 has the additional pocket 32, which is prepared and configured 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 by an additional fold-down or folding edge 30, which is positioned directly next to the pocket 32. The medical product 8 is placed in the pocket 32 and is preferably vacuumed and heat-sealed/sealed in this pocket. The air pockets are (continuously) folded/wrapped around 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 between them the receiving space 23 for the pocket 32 with the first sterile barrier 4. The fold-down or folding edges 30, which separate the two air pockets 10 and the additional pocket 32, may be configured as a linear and/or point-shaped weld seam. The linear weld seam may extend over the entire length of the edge, but it may also be interrupted. If the weld seam is interrupted in a linear or point-shaped manner, the air pockets may be in (fluid) communication with each other. The fold-down or folding edges 30 may also consist of several parallel weld seams.
[0066] The air pocket 10, which is positioned directly next to the pocket 32, is first folded down onto one side of the pocket 32. The other air pocket 10 is then folded down again to rest on the opposite side of the pocket 32. As a result, the pocket 32 is surrounded and protected by the air pockets on both sides.
[0067] FIG. 8 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 with the first sterile barrier 4 located therein. The pocket 32 is therefore arranged between the two air pockets 10. The pocket 32 is separated from the air pockets by the fold-down or folding edge 30. The pocket 32 has a tab 34 for sealing the pocket 32 after the first sterile barrier 4 with the medical product 8 has been inserted. The two air pockets are each folded down at the fold-down or folding edge 30 so that one air pocket rests against each side of the pocket 32. As a result, the pocket and the medical product 8 in the pocket are located in the receiving space 23 between the air pockets 10 and are protected from (at least) two sides.
LIST OF REFERENCE SIGNS
[0068] 1 sterile packaging [0069] 2 outer protective packaging [0070] 4 first sterile barrier [0071] 6 second sterile barrier [0072] 8 medical product [0073] 10 air pocket [0074] 18 sealing [0075] 19 double membrane [0076] 20 (outer) membrane [0077] 22 (inner) membrane [0078] 23 receiving space [0079] 24 sealing [0080] 28 sealing [0081] 30 fold-down or folding edge [0082] 32 additional pocket [0083] 34 tab
