Package Including an Areal Medical Device

Abstract

A package, which includes an areal medical device like a surgical mesh, comprises a folder supporting the areal medical device. The folder comprises a base panel, which has two side edges opposing each other and which includes at least one tab adapted for holding the areal medical device on the base panel. The folder further comprises two side flaps, each of the side flaps emerging from a respective one of said side edges of the base panel and being folded about said respective side edge onto the base panel into a respective folded state. The side flaps and the at least one tab cover at most 15% of the area of the areal medical device.

Claims

1. A package including an areal medical device, the package comprising a folder supporting the areal medical device, wherein the folder comprises a base panel which has two side edges opposing each other and which includes at least one tab adapted for holding the areal medical device on the base panel, the folder further comprises two side flaps, each of the side flaps emerging from a respective one of said side edges of the base panel and being folded about said respective side edge onto the base panel into a respective folded state, and the side flaps and the at least one tab cover at most 15% of the area of the areal medical device.

2. A package according to claim 1, wherein each of the side flaps includes at least one nose inserted through a corresponding slit in the base panel when the respective side flap is in its folded state.

3. A package according to claim 2, wherein at least one nose is formed as an extension to a side flap.

4. A package according to claim 2, wherein at least one nose is shaped as a nose tab formed by a cut in a side flap.

5. A package according to claim 1, wherein the base panel includes a plurality of tabs arranged for holding areal medical devices of different shapes and/or sizes.

6. A package according to claim 1, wherein at least one tab is formed by a cut in the base panel.

7. A package according to claim 1, wherein the folder is made in one piece.

8. A package according to claim 1, wherein the folder does not include panels and/or flaps in addition to said base panel and said two side flaps.

9. A package according to claim 1, wherein the folder is made of cardboard or paper.

10. A package according to claim 1, wherein the base panel has a central axis and both side flaps have the same size and are symmetrically arranged with respect to the central axis.

11. A package according to claim 1, wherein both side flaps, when in the folded state, touch the areal medical device.

12. A package according to claim 1, wherein the thickness of the folder including the areal medical device in the folded state of the side flaps is in the range of from 1 mm to 4 mm, measured perpendicularly to the base panel preferably in the range of from 2 mm to 3 mm.

13. A package according to claim 1, wherein the folder including the areal medical device is accommodated in a sealed pouch.

14. A package according to claim 1, wherein the folder is the only packaging component within the pouch.

15. A package according to claim 1, wherein the areal medical device comprises a surgical mesh implant.

Description

[0028] In the following, the invention is further explained by means of embodiments. The drawings show in

[0029] FIG. 1 a top view onto a first embodiment of a folder of a package according to the invention in an unfolded state,

[0030] FIG. 2 a top view onto the folder of FIG. 1 in the unfolded state holding a first type of surgical mesh,

[0031] FIG. 3 a top view onto the folder of FIG. 1 in the unfolded state holding a second type of surgical mesh,

[0032] FIG. 4 a three-dimensional view of the folder of FIG. 1 in the unfolded state,

[0033] FIG. 5 a three-dimensional view of the folder of FIG. 1 in the folded state,

[0034] FIG. 6 a top view onto a second embodiment of a folder of a package according to the invention in the unfolded state,

[0035] FIG. 7 a top view onto a third embodiment of a folder of a package according to the invention in the unfolded state,

[0036] FIG. 8 a three-dimensional view of the folder of FIG. 7 in the folded state, and

[0037] FIG. 9 a top view onto a forth embodiment of a folder of a package according to the invention in the unfolded state.

[0038] FIG. 1 illustrates the folder of a first embodiment of a package, which also includes an areal medical device and a sealed pouch, in which the folder holding the areal medical device can be accommodated. Since areal medical devices like surgical meshes and sealed pouches are well known in the art, these components of the package are not considered in detail, and the following description focuses on several embodiments of the folder and its handling.

[0039] The top view in FIG. 1 shows a first embodiment of the folder, which is designated by 1. The folder 1 comprises a base panel 10 which has two opposing side edges 12 and 13. The area of the base panel 10 is provided with a plurality of tabs 14, 15, 16 and 17, which are formed by an arcuate cut in the material of the base panel 10 each. Moreover, the base panel 10 is provided with two slits 18 and two slits 19 formed as cuts in the material of the base panel 10.

[0040] The folder 1 further comprises two side flaps 20 and 21, which emerge from the side edges 12 and 13, respectively. In the embodiment, the base panel 10 and the side flaps 20, 21 are made in one piece, e.g. punched from biocompatible paper material having an areal weight of, e.g., 220 g/cm.sup.2. The side edges 12 and 13 of the base panel 10 are designed as fold lines (crest lines) for the side flaps 20 and 21, respectively. In the embodiment, these fold lines each comprise a plurality of parallel indentations in the material of the folder 1 so that each fold line has a certain width and provides a smooth fold. The side flap 20 includes two noses 22, and the side flap 21 includes two noses 23. In the embodiment, the noses 22 and 23 are formed as extensions to the respective side flaps 20 and 21.

[0041] FIG. 2 illustrates the folder 1 in the unfolded state (as in FIG. 1) holding a first type of a surgical mesh 30, which is a flexible areal medical device. In FIG. 2, the surgical mesh 30 is held on the base panel 10 by three of the plurality of tabs, i.e. by the tab 14 and both tabs 15. The surgical mesh 30 is flexible and can be easily attached on the base panel 10 by slightly lifting the tabs 14 and 15 and shifting margin areas of the surgical mesh 30 under the respective tabs 14, 15. In the embodiment, the surgical mesh 30 is provided with marks to facilitate its handling (see, e.g., DE 10 2015 013 989 A1). These marks are easily visible when the surgical mesh 30 is presented on the folder 1.

[0042] FIG. 3 shows the folder 1 of FIG. 1 holding a circular surgical mesh 32, the shape of which is different from that of the elliptical surgical mesh 30. In FIG. 3, the tab 14 and both tabs 16 are used to hold the surgical mesh 32. This demonstrates that different types of areal medical devices can be held on one type of folder 1, when the tabs on the base panel 10 are arranged in an appropriate manner. In FIGS. 2 and 3, the tabs 14, 15 and 16 are used. FIG. 1 shows additional tabs, i.e. tabs 17, which can be utilized for holding other types or sizes of surgical meshes.

[0043] FIG. 4 illustrates the folder 1 of FIG. 1 in a three-dimensional view, in the unfolded state as in FIG. 1. The folded state, in which the side flap 20 is folded about the side edge or fold line 12 onto the base panel 10 and the side flap 21 is folded about the side edge or fold line 13 onto the base panel 10, is shown in FIG. 5.

[0044] FIG. 5 is for illustration purposes and does not display the areal medical device. When using the folder 1, first an areal medical device like the elliptical surgical mesh 30 or the circular surgical mesh 32 is attached to the base panel 10, as shown in FIGS. 2 and 3, and afterwards the side flaps 20 and 21 are folded onto the base panel 10 and onto the medical device. In the next step (which is not indicated in FIG. 5), the noses 22 and 23 are put through the respective slits 18 and 19 in order to fix the side flaps 20 and 21 in their folded state. Preferably, first the lower noses are pushed through the respective slits, and afterwards the upper noses, according to the representation in FIG. 5. These steps can be performed quickly, and any adhesive or adhesive labels are not required.

[0045] In the folded state, the side flaps 20, 21 as well as any tabs 14, 15, 16, 17 involved in holding the medical device cover at most 15% of the area of the medical device. Therefore, the elliptical surgical mesh 30 is not covered at all by the side flaps 20, 21, and the circular surgical mesh 32 is just slightly covered at part of its margin. In both cases, the respective surgical mesh 30, 32, which is flexible, can be easily taken from the folder 1, while the side flaps 20, 21 stay attached to the base panel 10 by means of the noses 22, 23 and slits 18, 19.

[0046] The exact position of the slits 18 and 19 determines an amount of upwardly directed vaulting of the side flaps 20 and 21. The closer the slits 18, 19 are located to the respective side edges 12, 13, the more pronounced is the vaulting effect of the side flaps 20, 21. This vaulting effect should not be so strong that the side flaps 20, 21 kink. If a vaulting effect is not desired, the distance of the slits 18, 19 to the respective side edges 12, 13 should be sufficiently large. In any case, when the folder 1 is in the folded state, as shown in FIG. 5, it exhibits at least a slight spacer effect, in particular when the fold lines at the side edges 12, 13 of the base panel 10 are relatively wide. The spacer effect is useful during sterilization of the folder and the medical device held therein, see below.

[0047] FIG. 6 shows a second embodiment of a folder, which is designated by 2. The folder 2 is similar to folder 1, for which reason the same reference numerals are used in FIGS. 6 and 1. The folder 2 is larger than folder 1, and its side flaps 20 and 21 as well as the arrangement of the tabs (here all designated by 17) are more symmetric than in FIG. 1.

[0048] FIG. 7 illustrates a third embodiment of a folder, which is designated by 3. Again, the same reference numerals are used for parts corresponding to each other.

[0049] The main difference between folder 3 and the folders 1 and 2 is the design of the noses put into slits 18 and 19 to keep the side flaps 20 and 21 in the respective folded state. In the folder 3, these noses are designed as nose tabs 42, 43 formed by adequate cuts in the side flaps 20, 21.

[0050] The base panel of folder 3 includes four tabs 44 for holding a smaller surgical mesh and four tabs 46 for holding a large essentially rectangular surgical mesh. The design of the folder 3 is particularly suited for larger surgical meshes, wherein the side flaps 20, 21 just cover narrow margins of the respective surgical mesh when in their folded states.

[0051] The folded state of folder 3 is shown in FIG. 8, wherein the nose tabs 42, 43 have not yet been put through the respective slits 18, 19 on the base panel 10.

[0052] FIG. 9 illustrates a folder 4 of a fourth embodiment, which is designed for a very large rectangular surgical mesh held by four tabs 46 on the base panel 10. The general design of the folder 4 is the same as that of folder 3, and again the same reference numerals are used for parts corresponding to each other.

[0053] So far, it has already been described (in particular in the context of folder 1) how an areal medical device can be placed on the base panel 10 of a folder, how the side flaps 20, 21 are folded and attached to the base panel 10, and how the medical device can be removed from the folder. Folders 2, 3, and 4 are handled in the same or in an analogous way, compared to folder 1.

[0054] It has already been mentioned that usually a package does not only comprise an areal medical device held in a folder, but also a sealed pouch. The sealed pouch encloses the folder including the medical device to protect it and keep it sterile. Such a pouch may be made of laminated film material including an aluminum foil and may have a flat rectangular shape. Initially, three edges of the pouch may be closed, and the folder holding the medical device can be inserted into the pouch via its forth edge.

[0055] To sterilize the folder and the medical device, ethylene oxide gas can be used. In this case, the gas enters the pouch via the fourth edge. Because of the spacer effect provided by the folder, as explained above, the gas can easily reach the medical device inside the pouch. Moreover, as explained as well, the top face of the medical device is largely not in contact with the folder, which avoids discoloration or fading of the medical device. After removal of the gas, e.g. by means of a vacuum pump, optionally followed by one or more than one vacuum drying step, the pouch is sealed along its fourth edge, under sterile conditions.