Outer packaging for medical products and method for packaging medical products

Abstract

The present invention relates to a foldable outer package (1) for a medical product (3). The outer package (1) comprises a base plate part (6) divided into three segments (6a, 6b, 6c) by two parallel and spaced apart folding creases (10, 11) and a pivot plate part (5) connected to the base plate part (6) by a pivot crease (8) perpendicular to the folding creases (10, 11), the pivot plate part (5) being divided into three segments (5a, 5b, 5c) by the folding creases (10, 11) which extend linearly into the pivot plate part (5). The present invention also relates to a method for packaging a medical product (3) using a foldable outer package (1), the method comprising: a pivot plate portion (5) having a window-like cutout portion (14) (or opening) in a central segment (5b) of the three segments (5a, 5b, 5c), and a side plate portion (7) connected to the pivot plate portion (5) via a folding crease (9) parallel to the pivot crease (8), the side plate portion (7) being subdivided into three segments (7a, 7b, 7c) via folding creases (10, 11) which extend linearly further into the side plate portion (7).

Description

[Technical field]

[0001] The present invention relates to a foldable outer package for a packaged medical product and a method of packaging a medical product using the foldable outer package. [Background technology]

[0002] Medical products, such as bone implants, bone plates, intramedullary devices, artificial joints, etc., are usually packaged in a controlled environment (especially clean rooms) and then sterilized before being transported to a customer, such as a hospital. As a rule, a double sterile barrier system is used. The double sterile barrier may consist of two plastic bags (plastic bags) (primary packaging). The medical product is placed in the first (inner) plastic bag, evacuated and sealed. The sealed first plastic bag is then placed, while still in the controlled environment, in a second (outer) plastic bag, which is also evacuated and sealed. Note that more than two or only one plastic bag may be used as the sterile barrier. The plastic bag containing the medical product is placed in an outer box (secondary packaging), a cardboard box, or similar, for shipping and transportation.

[0003] The sterility barrier must be maintained intact to prevent contamination of the medical product. However, plastic pouches are dimensionally unstable. During shipping, if the plastic pouch is placed loosely in a conventional (standardized) outer box, the plastic pouch and the medical product may rub or bump against each other, damaging the plastic pouch and compromising the sterility guarantee. In particular, large and heavy medical products may be damaged when they move around in the secondary packaging and hit the inner walls of the secondary package. Therefore, additional protective components (e.g., foam or other cushioning materials) are usually used, increasing the overall cost and complexity of the outer packaging system.

[0004] To avoid damage, the plastic bag is instead packaged in a foldable individual package (secondary package), which is further placed in an outer box (tertiary package). For example, Patent Document 1 (EP 2739238) discloses an outer packaging system for medical devices or medical products. The outer packaging system of Patent Document 1 comprises a sealed plastic bag as a sterile primary package for a medical product and a foldable secondary package defining an interior space for holding the plastic bag.

[0005] Furthermore, EP 3357444 discloses an outer packaging assembly for medical devices comprising at least two plastic bags. The outer packaging assembly of EP 3357444 further comprises a support element, which is immovably fixed in the assembled state with respect to the interior of the at least two plastic bags. This fixing is performed by the plastic bags themselves, which are folded around the support element. Furthermore, EP 10014419 A1, EP 3789314 A1, US 2010 / 0320112 A1, EP 69813860 A1 and EP 102005038491 A1 also disclose foldable outer packaging.

[0006] However, known outer packaging always depends on the dimensions of the medical product and cannot be flexibly used in outer boxes of different sizes. The existing configurations are disadvantageous in terms of sustainability and also in terms of separating the outer packaging materials as easily as possible when discarding them, since the outer packaging is made of multiple materials or composite materials (plastic and paper). [Prior art documents] [Patent documents]

[0007] [Patent Document 1] European Patent No. 2739238 [Patent Document 2] European Patent No. 3357444 [Patent Document 3] DE 10014419 A1 [Patent Document 4] European Patent Application Publication No. 3789314 [Patent Document 5] US Patent Application Publication No. 2010 / 0320112 [Patent Document 6] DE 69813860 A1 [Patent Document 7] German Patent No. 102005038491 Summary of the Invention

[0008] The object and goal of the present invention is to eliminate or at least mitigate the disadvantages of the prior art, and in particular to provide a collapsible outer package that allows safe transport and easy disposal of sterile packaged medical products within a standardized outer box (tertiary packaging).

[0009] With regard to the overall outer packaging according to the invention, the above mentioned objects and aims are achieved by the subject matter of claim 1.

[0010] The outer package according to the present invention (e.g. made from cardboard material) comprises a base plate portion (base panel portion) subdivided (divided) into three segments via two parallel and spaced apart fold lines, a pivot plate portion (pivot panel portion, hinge plate portion, hinge panel portion) connected to the base plate portion via pivot (hinge) fold lines arranged perpendicular to the fold lines, the pivot plate portion being subdivided (divided) into the three segments via the fold lines extending linearly into the pivot plate portion, the pivot plate portion having a window-like cutout or opening in a central one of the three segments, and a side plate portion (side panel portion) connected to the pivot plate portion via a fold back fold line arranged parallel to the fold lines, the side plate portion being subdivided (divided) into the three segments via the fold lines extending linearly into the side plate portion.

[0011] According to the invention, the pivot crease extends over the entire length of the base plate portion and the pivot plate portion.

[0012] Advantageous embodiments are set out in the dependent claims and are explained below.

[0013] The folding crease may also advantageously extend over the entire length of the side plate portion and the pivot plate portion.

[0014] According to a particularly advantageous further development, the base plate part, in particular the central one of the three segments, may have a cut pattern, preferably in the form of a number of longitudinal cuts, although the cut pattern may also be configured in any other form, for example in the form of a number of cross sections.

[0015] According to an advantageous embodiment, the outer packaging may be made from conventional packaging materials, such as corrugated cardboard or paperboard (cardboard).

[0016] The present invention further relates to a method for packaging a medical product (3) using the foldable outer package according to the above-mentioned invention, comprising the steps of placing (positioning) a medical product on a central segment of the three segments of the base plate, pivoting the swivel plate along the pivot crease line until the swivel plate is placed on the base plate such that the medical product protrudes from the window-like cutout, folding the side plate along the fold line to sandwich the base plate between the side plate and the swivel plate, and folding both end segments of the base plate, the swivel plate and the side plate along the folding crease line towards the medical product.

[0017] Preferably, the medical product is packaged in a sterile outer packaging before being placed on the central segment of the three segments of the base plate part. The medical product is packaged in a plastic bag as a sterile outer packaging (sterile barrier, sterile barrier system, primary packaging). Alternatively, the medical product may be packaged in two or more plastic bags, for example in the form of a double barrier system.

[0018] According to an advantageous further development, after the step of folding the end segments of the base plate part, the pivot plate part and the side plate part, respectively, along the folding creases in the direction towards the medical product, the outer package may be packed together with the medical product in a preferably standardised outer box. It is particularly advantageous if the outer box is made of the same packaging material as the foldable outer package (e.g. cardboard or carton). Of course, other packaging materials are also conceivable, as long as the outer package and the outer box are made of the same material.

[0019] According to the invention, the window cut-out may be adapted or adaptable (e.g. by cutting) to the dimensions of the medical product, for example if the medical product has a rectangular or oval cross section it may be useful if the cut-out is also rectangular or oval.

[0020] In other words, the present invention relates to a blank (blank sheet) for the outer package, which includes the base plate portion, the pivot plate portion, and the side plate portion. In the blank according to the present invention, the base plate portion, the pivot plate portion, and the side plate portion are arranged in this order and are connected to each other via a pivot crease and a folding crease. The medical product placed on the base plate portion is fixed to the outer package by folding the blank according to the present invention along the pivot crease and the folding crease. Preferably, the blank according to the present invention may further include a first side flap and a second side flap connected to the pivot plate portion and the base plate portion via the first folding crease and the second folding crease. As a result, when the first and second side flaps are folded along the first folding crease and the second folding crease, a cavity into which the medical product is inserted is formed between the first and second side flaps. Preferably, the pivot crease and the folding crease may be arranged parallel to each other and the first folding crease and the second folding crease may be arranged perpendicular to the pivot crease and the folding crease, respectively. Particularly preferably, the first and second side flaps and the base plate portion are capable of fixing the outer package in a preferably standardized outer box (tertiary packaging).

[0021] In other words, the present invention further relates to a method for packaging a medical product preferably within the foldable exterior package according to the above invention. The method includes placing (positioning) the medical product on the base plate portion of the exterior package, folding the exterior package along the folding lines for rotation and the folding lines for folding back so as to fix the medical product to the exterior package, and folding the exterior package along the folding lines for the first folding and the folding lines for the second folding so as to form a cavity portion into which the medical product penetrates.

Brief Description of the Drawings

[0022] The present invention will be described in more detail with reference to the preferred embodiments using the following drawings.

[0023] [Figure 1] Shows a blank of the exterior package according to the preferred embodiment. [Diagram 2] Shows a first step for packaging a medical product with the exterior package according to the preferred embodiment. [Diagram 3] Shows a second step for packaging a medical product with the exterior package according to the preferred embodiment. [Figure 4] Shows a second step for packaging a medical product with the exterior package according to the preferred embodiment. [Diagram 5] Shows a third step for packaging a medical product with the exterior package according to the preferred embodiment. [Figure 6] Shows a third step for packaging a medical product with the exterior package according to the preferred embodiment. [Figure 7] Shows a fourth step for packaging a medical product with the exterior package according to the preferred embodiment. [Figure 8] Shows a step for packaging the medical product packaged with the exterior package according to the preferred embodiment with a tertiary package. [Figure 9] Shows the medical product packaged with the tertiary package. [Figure 10]1 shows a medical product packaged in tertiary packaging. [Figure 11] 1 shows a medical product packaged in tertiary packaging. [Figure 12] 4 shows a blank for an outer package according to a variant of the preferred embodiment; [Figure 13] 1 shows a medical product packaged in an outer package according to a variation of the preferred embodiment. [Figure 14] A medical product packaged in an outer package according to a variation of the preferred embodiment is shown in a tertiary packaging state.

[0024] The above figures are schematic in nature and are provided solely for the purpose of understanding the invention, with identical elements being provided with the same reference numerals. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0025] Figure 1 shows a foldable outer package 1 in an unfolded (unfolded) state. The outer package 1 is used for packaging (secondary packaging) medical products 3 packaged in a sterile primary package (sterile barrier) 2. In other words, Figure 1 shows a blank (folded sheet) 4 of the outer package 1 according to a preferred embodiment.

[0026] The outer package 1 according to the preferred embodiment has a pivot plate portion (pivot panel portion, hinge plate portion, hinge panel portion) 5, a base plate portion (base panel portion) 6, and a side plate portion (side panel portion) 7, which are connected to each other via a pivot crease line 8 and a folding crease line 9. The pivot plate portion 5 is connected to the base plate portion 6 via the pivot crease line 8, and is connected to the side plate portion 7 via the folding crease line 9. In the top view shown in FIG. 1, the side plate portion 7, the pivot plate portion 5, and the base plate portion 6 are disposed adjacent to each other and are connected to each other via the pivot crease line 8 or the folding crease line 9, respectively. The pivot crease line 8 and the folding crease line 9 are disposed approximately parallel to each other, and divide the blank 4 into three elements (i.e., the side plate portion 7, the pivot plate portion 5, and the base plate portion 6) (by the vertical boundary line in FIG. 1). 1, one surface of the pivot plate part 5 is equal to one surface of the base plate part 6, so that the pivot plate part 5 completely covers the base plate part 6 when folded over the base plate part 6 along the pivot crease line 8, as will be explained in more detail below.

[0027] As shown in FIG. 1, the outer package 1, i.e., the blank 4, further has a first folding crease 10 and a second folding crease 11. The first folding crease 10 and the second folding crease 11 are disposed substantially perpendicular to the pivot crease 8 and the fold-back crease 9. As a result, the blank 4 is subdivided into three segments (horizontal segments) in a direction extending along the pivot crease 8 and the fold-back crease 9. In other words, the pivot plate portion 5, the base plate portion 6, and the side plate portion 7 are each subdivided into three overlapping segments by the first folding crease 10 and the second folding crease 11. The pivot plate portion 5 is subdivided into a first (lower) pivot plate segment 5a, a second (middle) pivot plate segment 5b, and a third (upper) pivot plate segment 5c. Similarly, the base plate portion 6 is subdivided into a first (lower) base plate segment 6a, a second (middle) base plate segment 6b, and a third (upper) base plate segment 6c by a first folding crease line 10 and a second folding crease line 11. The side plate portion 7 is subdivided into a first (lower) side plate segment 7a, a second (middle) side plate segment 7b, and a third (upper) side plate segment 7c by a first folding crease line 10 and a second folding crease line 11.

[0028] The first segment (i.e., the first pivot plate segment 5a, the first base plate segment 6a, or the first side plate segment 7a) and the third segment (i.e., the third pivot plate segment 5c, the third base plate segment 6c, or the third side plate segment 7c) have the same size (outer dimensions) as each other. That is, in the plan view of FIG. 1, the distance between the horizontal lower edge of the blank 4 and the first fold line 10 is equal to the distance between the horizontal upper edge of the blank 4 and the second fold line 11.

[0029] As shown in FIG. 1, the blank 4 of the outer package 1 is divided into the nine segments 5a, 5b, 5c, 6a, 6b, 6c, 7a, 7b, 7c by the creases 8, 9, 10, 11. The creases 8 for turning are arranged between the segments 5a, 5b, 5c forming the turning plate part 5 and the segments 6a, 6b, 6c forming the base plate part 6. The creases 9 for folding are formed between the segments 5a, 5b, 5c of the turning plate part 5 and the segments 7a, 7b, 7c of the side plate part 7. The first folding creases 10 are formed between the segments 5a, 6a, 7a forming the first side flap 12 and the segments 5b, 6b, 7b, and the second folding creases 11 are arranged between the segments 5b, 6b, 7b and the segments 5c, 6c, 7c of the second side flap 13.

[0030] As shown in FIG. 1, the pivot plate portion 5 (particularly the second (middle) pivot plate segment 5b) is formed with a cutout (opening) 14. In a preferred embodiment, the cutout 14 is formed in the shape of a rectangular through opening. The shape and dimensions of the cutout 14 are adapted to the medical product 3 to be packaged in the outer package 1, as will be explained in more detail below. For example, the cutout 14 may be circular, oval or in the shape of any polygon.

[0031] To package the medical product 3 in the outer package 1, first, in a first step as shown in Fig. 2, the medical product 3 sterilely packaged in the primary package 2 is placed on the base plate part 6 (particularly the second (middle) base plate segment 6b). As shown in Fig. 2, the primary package 2 may protrude beyond the second base plate segment 6b as long as the medical product 3 in the primary package 2 is placed on the second base plate segment 6b. In other words, the base plate part 6 functions as a place (a receiving part) for the medical product 3 packaged in the primary package 2.

[0032] In a second step, shown in Figures 3 and 4, the pivot plate part 5 together with the side plate part 7 is folded along the pivot crease line 8 towards the base plate part 6, so that the pivot plate part 5 substantially covers the base plate part 6. The medical product 3 in the primary package 2 protrudes through the cut-out 14 of the pivot plate part 5. In other words, in the folded state, the cut-out 14 surrounds the medical product 3 so as to fix the medical product 3 relative to the outer package 1.

[0033] 5 and 6, the side plate portion 7 is folded inward along the folding crease 9 toward the underside of the base plate portion 6. This causes the swivel plate portion 5 to be held on the base plate portion 6. In other words, the side plate portion 7 is folded along the folding crease 9 so as to sandwich the base plate portion 6 between the side plate portion 7 itself and the swivel plate portion 5.

[0034] In a fourth step shown in FIG. 7, the side flaps 12, 13 (i.e. the overlapping segments 5a, 6a, 7a and the overlapping segments 5b, 6b, 7b) are folded upwards towards the medical product 3 protruding from the cutout 14. When the medical product 3 packed in the outer package 1 is then placed in a preferably standardized outer box (tertiary packaging) 15, e.g. for transport or shipping, the inherent elasticity of the material of the outer box causes the side flaps 12, 13 to be folded outwards again and in so doing come into contact with the inner surface of the outer box 15. That is, as shown in FIG. 9, the outer package 1 according to the preferred embodiment is folded with the underside of the base plate portion 6 (i.e. the surface facing away from the medical product 3) facing the first inner surface of the outer box 15. The edges of the side flaps 12, 13 of the outer package 1 come into contact with a second inner surface of the outer box 15 opposite the first inner surface. This holds the outer package 1 in the outer box 15. In other words, the outer package 1 extends within the outer box 15 .

[0035] 9, the pair of side flaps 12, 13 form a cavity therebetween, into which the medical product 3 can be inserted. In other words, the medical product 3 is fixed in the outer box 15 by the outer package 1 without leaning against any one of the inner surfaces of the outer box 15 or coming into contact with the outer box 15. This prevents damage to the primary package 2 and the associated deterioration of the sterility of the medical product 3.

[0036] 10 and 11, the outer package 1 can be used for various sizes of medical products 3. When a large medical product 3 is packed in the outer package 1, and thus in the outer box 15, the side flaps 12, 13 are positioned at a closer angle to the vertical than when a small medical product 3 is packed, thereby forming a larger cavity between the side flaps 12, 13.

[0037] 12 to 14 show an outer package 1 according to a variant of the preferred embodiment. In this variant, the base plate part 6 (particularly the second (middle) base plate segment 6b) has a cut pattern 16. According to the variant of the preferred embodiment, the cut pattern 16 is formed in the base plate part 6 in the form of a plurality of individual longitudinal cuts (arranged in rows). When the outer package 1 is folded according to the variant of the preferred embodiment and placed in the outer box 15, the cut pattern 16 provides additional cushioning between the outer box 15 and the medical product 3. Furthermore, the base plate part 6 (particularly the second (middle) base plate segment 6b) is more flexible (flexible) due to the longitudinal cuts (longitudinal slits) than if no cuts were provided. This allows the base plate part 6 (particularly the second (middle) base plate segment 6b) to adapt to the contour of the medical product 3 placed thereon (see in particular FIG. 13).

[0038] In a preferred embodiment, the outer package 1 is made of a conventional outer packaging material (e.g., cardboard or carton). Since the outer box 15 is also made of a conventional outer packaging material, there is no need to separate the outer packaging components by material type when disposing of the outer package. Of course, materials other than those mentioned above may be used for the outer package 1 and the outer box 15 as long as the same material is used for the outer package 1 and the outer box 15. [Explanation of symbols]

[0039] 1 Outer packaging 2 Primary packaging 3. Medical Products 4 Blank 5 Swivel plate section 5a First pivot plate segment 5b Second pivot plate segment 5c Third pivot plate segment 6 Base plate part 6a First base plate segment 6b Second base plate segment 6c Third base plate segment 7 Side plate part 7a First side plate segment 7b Second side plate segment 7c Third side plate segment 8. Folding lines for turning 9 Folding crease 10 First fold line 11 Second fold line 12 First side flap 13 Second Side Flap 14 Cutting 15 Outer box 16 Cutting Pattern

Claims

1. A foldable outer package (1) for a medical product (3), comprising: a base plate portion (6) subdivided into three segments (6a, 6b, 6c) by two parallel and spaced apart folding creases (10, 11); a pivot plate portion (5) connected to the base plate portion (6) via a pivot crease (8) arranged perpendicular to the folding creases (10, 11), the pivot plate portion (5) being divided into three segments (5a, 5b, 5c) via the folding creases (10, 11) extending linearly into the pivot plate portion (5), the pivot plate portion (5) having a window-shaped cutout (14) (or opening) in the central segment (5b) of the three segments (5a, 5b, 5c); a side plate portion (7) connected to the pivot plate portion (5) via a folding crease (9) arranged parallel to the pivot crease (8), the side plate portion (7) being divided into three segments (7a, 7b, 7c) via the folding creases (10, 11) extending linearly into the side plate portion (7); the pivot crease (8) extends over the entire length of the base plate portion (6) and the pivot plate portion (5), Outer packaging.

2. the folding crease (9) extends over the entire length of the side plate portion (7) and the pivot plate portion (5), The outer package of claim 1 .

3. characterised in that the base plate portion (6), in particular the central segment (6b) of the three segments (6a, 6b, 6c), has a cut pattern (16), preferably in the form of a plurality of individual longitudinal cuts. The outer package according to claim 1 or 2.

4. A method for packaging a medical product (3) using a foldable outer package (1) according to any one of claims 1 to 3, comprising the steps of: placing a medical product (3) on a central segment (6b) of the three segments (6a, 6b, 6c) of the base plate portion (6); pivoting the pivot plate part (5) along the pivot crease (8) until the pivot plate part (5) rests on the base plate part (6) such that the medical product (3) protrudes through the window cutout (14); folding back the side plate portion (7) along the folding crease (9) so as to sandwich the base plate portion (6) between the side plate portion (7) and the swivel plate portion (5); folding both end segments (5a, 5c, 6a, 6c, 7a, 7c) of the three segments of the base plate portion (6), the pivot plate portion (5) and the side plate portion (7) along the folding creases (10, 11) toward the medical product (3); A method for providing the above.

5. characterised in that the medical product (3) is packaged in a sterile outer packaging before being placed on the central segment (6b) of the three segments (6a, 6b, 6c) of the base plate part (6). The method according to claim 4.

6. After the step of folding both end segments (5a, 5c, 6a, 6c, 7a, 7c) of the three segments of the base plate portion (6), the pivot plate portion (5) and the side plate portion (7) along the folding creases (10, 11) toward the medical product (3), characterised in that the outer package (1) is packed together with the medical product (3) in a preferably standardised outer box (15), The method according to claim 4 or claim 5.

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