REPACKAGING OF A MEDICAL PRODUCT AND METHOD FOR REPACKAGING A MEDICAL PRODUCT

Description

[0001] The disclosure relates to a foldable outer packaging for a medical product, as well as a method for repackaging a medical product using the foldable outer packaging. Background of the Revelation

[0002] Medical devices such as bone implants, bone plates, intramedullary devices, artificial joints, or similar devices are typically packaged in a controlled environment, particularly a clean room, and then sterilized before transport to a customer, such as a hospital. Typically, a double sterile barrier system is used for this purpose. The double sterile barrier can consist of two plastic bags (primary packaging). The medical device is inserted into a first, inner plastic bag, which is vacuum-sealed and sealed. While still in the controlled environment, the sealed first plastic bag is then placed into a second, outer plastic bag, which is also vacuum-sealed and sealed. More than two plastic bags, or just a single plastic bag, can be used as a sterile barrier.The plastic bag(s) containing the medical device are then placed in an outer packaging box (secondary packaging), a carton or similar, for shipping and transport and then transported.

[0003] The sterile barrier must remain intact to prevent contamination of the medical device. However, the plastic bag is dimensionally unstable. However, if the plastic bags are arranged loosely in a conventional (standardized) outer packaging box during transport, damage to the plastic bags can occur due to rubbing or impacting of the plastic bags and medical devices, which compromises the guarantee of sterility. Large and heavy medical devices, in particular, can damage the plastic bags when they move within the secondary packaging and impact the inner walls of the secondary packaging. Therefore, additional protective components, such as foam or other cushioning materials, are usually provided, which adversely contribute to the overall cost and complexity of the outer packaging system.

[0004] To prevent damage, the plastic bags are alternatively packaged in foldable individual packages (secondary packaging), which are then placed in the outer packaging box (tertiary packaging). For example, EP 2 739 238 B1 shows an outer packaging system for a medical device or medical product with a sealed plastic bag as sterile primary packaging for the medical product and a foldable secondary packaging that defines an interior space for accommodating the plastic bag.

[0005] Furthermore, EP 3 357 444 B1 discloses an outer packaging arrangement for a medical device, which outer packaging arrangement comprises at least two plastic bags. The outer packaging arrangement further comprises a support element which, in an assembled configuration, is secured against movement relative to the interior of the at least two plastic bags. This securing is achieved by the plastic bags themselves, which are folded around the support element. Furthermore, foldable outer packaging is also shown in DE 100 14 419 A1, EP 3 789 314 A1, US 2010 / 0 320 112 A1, DE 698 13 860 T2, DE 10 2005 038 491 B3, DE 93 17 306 U1, or FR 893 332 A.

[0006] However, the existing outer packaging always depends on the dimensions of the medical device and, moreover, cannot be used flexibly in outer packaging boxes of different sizes. Current solutions are also disadvantageous from the perspective of sustainability and the simplest possible separation of outer packaging materials during disposal, as they consist of different materials / composites (plastic / paper). Summary of Revelation

[0007] The objects and aims of the disclosure are to eliminate or at least mitigate the disadvantages of the prior art and, in particular, to provide a foldable outer packaging which enables safe transport of sterile packaged medical devices in standardized outer packaging boxes (tertiary packaging) while allowing easy disposal.

[0008] The objects and aims are achieved according to the invention with regard to a generic outer packaging by the subject matter of claim 1.

[0009] The outer packaging (made, for example, from cardboard material) accordingly includes a base plate which is divided into three segments by means of two parallel, spaced-apart folding fold lines, a pivoting plate which is coupled to the base plate via a pivoting fold line aligned perpendicular to the folding fold lines, is also divided into three segments by means of the folding fold lines extending in a straight line into the pivoting plate, and has a window-like cutout or opening in the middle of the three segments, and a side plate which is coupled to the pivoting plate via a fold-over line aligned parallel to the pivoting fold line, and is also divided into three segments by means of the folding fold lines extending in a straight line further into the side plate.

[0010] According to the invention, the pivot fold line extends over the entire length of the base plate and the pivot plate.

[0011] According to the invention, the middle of the three segments of the base plate has a cutting pattern in the form of a plurality of longitudinal cuts. Advantageous embodiments are claimed in the subclaims and are explained below.

[0012] Furthermore, it may be advantageous if the fold line extends over the entire length of the side plate and the pivot plate.

[0013] According to an advantageous embodiment, the outer packaging can be made of a conventional packaging material, such as cardboard or paperboard.

[0014] Furthermore, the invention relates to a method for repackaging a medical product using a foldable outer packaging according to claim 1 or 2 with the following method steps: Placing a medical product on the middle of the three segments of the base plate; pivoting the pivot plate along the pivot fold line until the pivot plate rests on the base plate with the medical product protruding through the window-like cutout; folding the side plate along the fold line to sandwich the base plate between the side plate and the pivot plate; and folding the two outermost of the three segments of the base plate, pivot plate, and side plate along the respective fold lines towards the medical product.

[0015] Preferably, the medical device can be packaged in a sterile outer packaging before being placed on the middle of the three segments of the base plate. The medical device can be packaged in a plastic bag as a sterile outer packaging / sterile barrier / sterile barrier system / primary packaging. Alternatively, it is also conceivable for the medical device to be packaged in two or more plastic bags, for example, in the form of a double-barrier system.

[0016] According to an advantageous development, the outer packaging, together with the medical product, can be packaged in a preferably standardized outer packaging box after folding the two outer segments of the base plate, pivot plate, and side plate along the respective folding fold lines toward the medical product. It is particularly advantageous if the outer packaging box is made of the same packaging material as the foldable outer packaging, for example, cardboard or paperboard. Of course, other packaging materials are also conceivable, as long as the outer packaging and the outer packaging box are made of the same material.

[0017] According to the disclosure, it is also conceivable for the window-like cutout to be adapted or adaptable to the dimensions of the medical device (e.g., by cutting it out). For example, if the medical device has a rectangular or elliptical cross-section, it may be expedient for the cutout to also be rectangular or elliptical.

[0018] In other words, the disclosure relates to a blank of the outer packaging comprising the base plate, the pivot plate, and the side plate, which are arranged next to one another in this order and connected via the pivot fold line and the fold-over fold line. Folding the blank along the pivot fold line and the fold-over fold line fixes a medical device placed on the base plate relative to the outer packaging. Preferably, the blank can further comprise a first side flap and a second side flap, which are connected to the pivot plate and the base plate via the first fold-over fold line and the second fold-over fold line, such that when the side flaps are folded along the first fold-over fold line and the fourth fold-over fold line, a cavity is formed between the side flaps, into which the medical device protrudes.Preferably, the pivot fold line and the fold-over fold line can be arranged parallel to each other, and the first folding fold line and the second folding fold line can each be arranged perpendicular to the pivot fold line and the fold-over fold line. Particularly preferably, the side flaps and the base plate can fix the outer packaging in a preferably standardized outer packaging box (tertiary packaging).

[0019] In other words, the disclosure further relates to a method for packaging a medical device in a foldable outer packaging, preferably according to the invention, comprising the following steps: Placing the medical device on the base plate of the outer packaging; folding the outer packaging along a pivot fold line and a fold-over fold line to fix the medical device relative to the outer packaging; and folding the outer packaging along a first fold line and a second fold line to form a cavity into which the medical device protrudes. Short description of the characters

[0020] The disclosure is explained in more detail below using a preferred embodiment with the aid of figures. They show: Fig. 1 shows a blank of an outer packaging; Fig. 2 shows a first step for packaging a medical device with the outer packaging; Figs. 3, 4 show a second step for packaging the medical device with the outer packaging; Figs. 5, 6 show a third step for packaging the medical device with the outer packaging; Fig. 7 shows a fourth step for packaging the medical device with the outer packaging; Fig. 8 shows a step for packaging the medical device packaged with the outer packaging in tertiary packaging; Fig. 9 shows the medical device packaged in the tertiary packaging; Figs. 10, 11 show medical devices packaged in the tertiary packaging; Fig. 12 shows a blank of an outer packaging according to a preferred embodiment of the invention; Fig. 13 shows a medical device packaged in the outer packaging according to the preferred embodiment of the invention; and Fig. 14 shows the medical device packaged in the outer packaging according to the preferred embodiment of the invention in the tertiary packaging

[0021] The figures are schematic in nature and serve only to facilitate understanding of the invention. Identical elements are designated by the same reference numerals. Detailed description of a preferred embodiment

[0022] Fig. 1 shows a foldable (secondary) outer packaging 1 for a medical device 3 packaged in a sterile primary packaging / sterile barrier 2 in an unfolded state. In other words, Fig. 1 a blank or folded sheet 4 of the outer packaging 1 according to a preferred embodiment.

[0023] The outer packaging 1 comprises a pivot plate 5, a base plate 6 and a side plate 7, which are each connected to one another via a pivot fold line 8 and a fold line 9. The pivot plate 5 is connected to the base plate 6 via a pivot fold line 8 and to the side plate 7 via a fold line 9. In the Fig. 1Consequently, in the plan view shown, the side plate 7, the pivot plate 5 and the base plate 6 are arranged next to each other and are connected to each other via the fold line 9 and the pivot fold line 8. The pivot fold line 8 and the fold line 9 are arranged essentially parallel and divide the blank 4 (in Fig. 1 vertically) into three elements, namely the side plate 7, the swivel plate 5 and the base plate 6. A surface of the swivel plate 5 is shown in a plan view as in Fig. 1 shown, equal to an area of ​​the base plate 6, so that, as described in more detail below, the pivot plate 5, when folded along the pivot fold line 8 over the base plate 6, completely covers it.

[0024] As in Fig. 1As shown, the outer packaging 1 or the blank 4 further has a first folding fold line 10 and a second folding fold line 11. The first folding fold line 10 and the second folding fold line 11 are arranged essentially perpendicular to the pivot fold line 8 and the fold-over fold line 9. The blank 4 is thus divided into three (horizontal) segments in its direction of extension along the pivot fold line 8 and the fold-over fold line 9. In other words, the pivot plate 5, the base plate 6 and the side plate 7 are each divided into three segments arranged one above the other by the first folding fold line 10 and the second folding fold line 11. The pivot plate 5 is thus divided into a first, lower pivot plate segment 5a, a second, middle pivot plate segment 5b and a third, upper pivot plate segment 5c.Likewise, the base plate 6 is divided by the first folding fold line 10 and the second folding fold line 11 into a first, lower base plate segment 6a, a second, middle base plate segment 6b, and a third, upper base plate segment 6c. The side plate 7 is divided by the first folding fold line 10 and the second folding fold line 11 into a first, lower side plate segment 7a, a second, middle side plate segment 7b, and a third, upper side plate segment 7c.

[0025] The first and third segments, ie the first pivot plate segment 5a and the third pivot plate segment 5c, the first base plate segment 6a and the third base plate segment 6c as well as the first side plate segment 7a and the third side plate segment 7c, are each the same size or have the same external dimensions. That is, in the plan view in Fig. 1the horizontal distance between the lower, horizontal outer edge of the blank 4 and the first folding fold line 10 is equal to the horizontal distance between the upper, horizontal outer edge of the blank 4 and the second folding fold line 11.

[0026] As in Fig. 1As can be seen, the blank 4 of the outer packaging 1 is divided by the fold lines 8, 9, 10, 11 into the nine segments 5a, 5b, 5c, 6a, 6b, 6c, 7a, 7b, 7c. The pivot fold line 8 is arranged between the segments 5a, 5b, 5c, which form the pivot plate 5, and the segments 6a, 6b, 6c, which form the base plate 6. The fold line 9 is formed between the segments 5a, 5b, 5c of the pivot plate 5 and the segments 7a, 7b, 7c of the side plate 7. The first folding fold line 10 is formed between the segments 5a, 6a, 7a, which form a first side flap 12, and the segments 5b, 6b, 7b, whereas the second folding fold line 11 is arranged between the segments 5b, 6b, 7b and the segments 5c, 6c, 7c of a second side flap 13.

[0027] In the swivel plate 5, in particular in the second, middle swivel plate segment 5b, as shown in Fig. 1As shown, a cutout 14 is formed. In the preferred embodiment, the cutout 14 is shaped as a rectangular through-opening. The shape and dimensions of the cutout 14 are adapted, as described in more detail below, to the medical device 3 to be packaged with the outer packaging 1. For example, the cutout 14 can also be circular or elliptical, or in the shape of any desired polygon.

[0028] In order to package the medical device 3 with the outer packaging 1, first, in a first, in Fig. 2 In the step shown, the medical device 3, which is sterile-packaged in the primary packaging 2, is placed on the base plate 6, in particular the second, middle base plate segment 6b. The primary packaging 2 can, as shown in Fig. 2shown, protrude beyond the second base plate segment 6b as long as the medical device 3 is arranged in the primary packaging 2 on the second base plate segment 6b. In other words, the base plate 6 serves as a receptacle for the medical device 3 packaged in the primary packaging 2.

[0029] In a second, in the Figs. 3 and 4 In the step shown, the pivot plate 5 together with the side plate 7 is folded along the pivot fold line 8 toward the base plate 6, so that the pivot plate 5 essentially covers the base plate 6. The medical device 3 in the primary packaging 2 protrudes through the cutout 14 of the pivot plate 5. This means that the cutout 14 encompasses / encloses the medical device 3 in the folded state in order to fix it relative to the outer packaging 1.

[0030] The side plate 7 is then inserted into a third Figs. 5 and 6In the step shown, the side plate 7 is folded or folded inward along the fold line 9 toward a bottom side of the base plate 6 so as to hold the pivot plate 5 on the base plate 6. In other words, the side plate 7 is folded along the fold line 9 so as to sandwich the base plate 6 between itself and the pivot plate 5.

[0031] In a fourth, in Fig. 7In the step shown, the side flaps 12 and 13, ie the superimposed segments 5a, 6a, 7a as well as the superimposed segments 5b, 6b, 7b, are folded upwards in the direction of the medical device 3 protruding through the cutout 14. If the medical device 3 packaged in the outer packaging 1 is now placed, for example for transport or shipping, in a preferably standardized outer packaging box (tertiary packaging) 15, the side flaps 12, 13 fold outwards again due to the inherent elasticity of the outer packaging material and in doing so abut against the inner surfaces of the outer packaging box 15. This means that the outer packaging 1 according to the preferred embodiment lies, as in Fig. 9As shown, in the folded state, the underside of the base plate 6, i.e., the side facing away from the medical device 3, rests against a first inner surface of the outer packaging box 15. The edges of the side flaps 12, 13 of the outer packaging rest on a second inner surface of the outer packaging box 15 opposite the first inner surface, so that the outer packaging 1 is held in the outer packaging box 15. In other words, the outer packaging 1 spreads out in the outer packaging box 15.

[0032] As in Fig. 9As shown, the side flaps 12, 13 form a hollow space between them into which the medical device 3 can protrude. This means that the medical device 3 is fixed by the outer packaging 1 in the outer packaging box 15 without resting against one of the inner surfaces of the outer packaging box 15 or coming into contact with the outer packaging box 15. This prevents damage to the primary packaging 2 and the associated impairment of the sterility of the medical device 3.

[0033] The outer packaging 1 can also be, as in the Figs. 10, 11 shown, can be used for medical devices 3 of different sizes. When a large medical device 3 is packaged in the outer packaging 1 or in the outer packaging box 15, the side flaps 12, 13 are more vertical than in smaller medical devices 3 and thus form a larger hollow space between them.

[0034] In the Figs. 12 to 14, an outer packaging 1 according to a preferred embodiment of the invention is depicted. The second, middle base plate segment 6b of the base plate 6 has a cutting pattern 16. The cutting pattern 16 is designed according to the preferred embodiment of the invention in the form of a plurality of individual (linearly arranged) longitudinal cuts in the base plate 6. When the outer packaging 1 according to the preferred embodiment of the invention is folded together and placed in the outer packaging box 15, the cutting pattern 16 ensures additional cushioning between the outer packaging box 15 and the medical device 3. In addition, the base plate 6, in particular its middle base plate segment 6b, is given greater flexibility than an uncut plate due to the longitudinal cuts (longitudinal slits) provided therein, so that it can approximately adapt to the external shape of a product placed thereon (see in particular Fig. 13 ).

[0035] In the preferred embodiment of the invention, the outer packaging 1 is made of a conventional outer packaging material, such as cardboard or paperboard. Since the outer packaging box 15 is also made of the conventional outer packaging material, separating the outer packaging components during disposal is no longer necessary. Of course, a different material can also be used for the outer packaging 1 and the outer packaging box 15, as long as the same material is used for the outer packaging components. List of reference symbols

[0036] 1Outer packaging 2Primary packaging 3Medical device 4Cut-out 5Pivot plate 5aFirst pivot plate segment 5bSecond pivot plate segment 5cThird pivot plate segment 6Base plate 6aFirst base plate segment 6bSecond base plate segment 6cThird base plate segment 7Side plate 7aFirst side plate segment 7bSecond side plate segment 7cThird side plate segment 8Pivot fold line 9Fold-over fold line 10First folding fold line 11Second folding fold line 12First side flap 13Second side flap 14Cut-out 15Outer packaging box 16Cutting pattern

Claims

1. A foldable outer packaging (1) for a medical product (3) with: - a base plate (6), which is divided into three segments (6a, 6b, 6c) via two parallel spaced folding fold lines (10, 11), - a pivot plate (5), which - is coupled to the base plate (6) via a pivoting fold line (8) aligned perpendicular to the folding fold lines (10, 11), - is also subdivided into three segments (5a, 5b, 5c) via the folding fold lines (10, 11) extending in a straight line into the pivot plate (5), and - has a window-like cut-out (14) (or aperture) in the middle (5b) of the three segments (5a, 5b, 5c), and - a side plate (7), which - is coupled to the pivot plate (5) via a turn-over fold line (9) aligned parallel to the pivoting fold line (8), and - is also divided into three segments (7a, 7b, 7c) via the folding fold lines (10, 11) that continue to extend in a straight line into the side plate (7), wherein the pivoting fold line (8) extends over the entire length of the base plate (6) and of the pivot plate (5), characterized in that the middle one (6b) of the three segments (6a, 6b, 6c) of the base plate (6) has a cutting pattern (16) in the form of a plurality of individual longitudinal cuts.

2. The outer packaging (1) according to claim 1, characterized in that the turn-over fold line (9) extends over the entire length of the side plate (7) and the pivot plate (5).

3. A method of packaging a medical device (3) using a foldable outer packaging (1) according to claim 1 or 2, comprising the following method steps: - placing a medical product (3) on the middle (6b) of the three segments (6a, 6b, 6c) of the base plate (6); - pivoting of the pivot plate (5) along the pivoting fold line (8) until the pivot plate (5) rests on the base plate (6) with the medical product (3) protruding through the window-like cut-out (14); - turning over the side plate (7) along the turn-over fold line (9) to sandwich the base plate (6) between the side plate (7) and the pivot plate (5), and - folding over the two outer segments (5a, 5c, 6a, 6c, 7a, 7c) of the three segments of the base plate (6), pivot plate (5) and side plate (7) along the respective folding fold lines (10, 11) in the direction of the medical product (3).

4. The method according to claim 3, characterized in that the medical product (3) is packaged in a sterile outer packaging (1) before being placed on the middle one (6b) of the three segments (6a, 6b, 6c) of the base plate (6).

5. The method according to claim 3 or 4, characterized in that the outer packaging (1) together with the medical product (3) is packaged in a, preferably standardized, outer packaging box (15) after folding over the two outer (5a, 5c, 6a, 6c, 7a, 7c) segments of the base plate (6), pivot plate (5) and side plate (7) along the respective folding fold lines (10, 11) in the direction of the medical product (3).