PACKAGING AND METHOD OF MANUFACTURING THE PACKAGING FOR A PRODUCT TO BE RECEIVED THEREIN

Abstract

A packaging with a packaging arrangement and at least one product received therein, such as in particular a medical product, and a method for manufacturing the packaging are disclosed. The packaging arrangement has a first packaging element, which has a trough-shaped receiving space for receiving the product, wherein the receiving space is delimited by a receiving base and a peripheral wall, which is connected with the receiving base. The packaging arrangement has a second packaging element inserted into the receiving space, which element has a plastically deformable deformation region and a plug-in region which extends peripherally around the deformation region and spans the same, wherein the product is arranged between the deformation region and the receiving base and the deformation region is at least plastically deformed in sections complementarily to the product, by contacting the same. The product is elastically clamped between the receiving base and the deformation region.

Claims

1. A packaging with a packaging arrangement and at least one product received therein, comprising: a first packaging element having a trough-shaped receiving space for receiving the at least one product, the receiving space being delimited by a receiving base and a peripheral wall connected to the receiving base; and a second packaging element inserted into the receiving space and having a plastically deformable deformation region and a plug-in region extending peripherally around the deformation region and spanning the deformation region, the at least one product being arranged between the deformation region and the receiving base, wherein the deformation region, due to the deformation region being in contact with the at least one product, is plastically deformed at least in regions complementary thereto, and wherein the at least one product is elastically clamped between the receiving base (14) and the deformation region.

2. The packaging of claim 1, wherein the receiving base is deformed and elastically prestressed against the at least one product.

3. The packaging of claim 2, wherein the first packaging element has a support spanning a positioning plane, wherein the receiving base extends with an offset in the gravitational direction above the positioning plane and thereby defines a lower-side cavity therewith, the receiving base being stretched into the cavity in order to produce the elastic prestressing.

4. The packaging of claim 3, wherein the receiving base extends at least in sections parallel to the positioning plane spanned by the support.

5. The packaging of claim 1, wherein the second packaging element is blister-shaped.

6. The packaging of claim 1, wherein a closing element for fixing the second packaging element on the first packaging element is provided, the closing element being connected with the first packaging element by interposing the second packaging element.

7. The packaging of claim 6, wherein the closing element and the first packaging element are designed in such a way that they have mutual sealable materials at least in the region where they contact one another.

8. The packaging of claim 6, wherein the first packaging element and the closing element have a peelable connection.

9. A packaging arrangement for manufacturing the packaging of claim 1.

10. A method for manufacturing the packaging of claim 1, comprising: in a first step, positioning the at least one product into the receiving space of the first packaging element; in a second step, subjecting the second packaging element to a heat treatment, with at least the deformation region being heated in such a way that the deformation region reaches a plastically deformable state; in a third step, inserting the second packaging element into the receiving space, wherein between the deformation region and the receiving base, a clamping region for the product is formed and the deformation region is plastically deformed at least in sections by contacting the product in a manner complementary to the product, and the receiving base is subjected to an external force, which generates a restoring force acting on the product, so that the receiving base is prestressed against the product and elastically deformed; and in a fourth step, fixing the second packaging element to the first packaging element.

11. The method according to claim 10, wherein the receiving base for producing the prestress acting on the product is stretched in the cavity on the underside of the first packaging element before and/or during the third step.

12. The method of claim 10, wherein the receiving base is heated before and/or during the third step.

13. The method of claim 10, wherein the prestress acting on the product is generated by a negative pressure applied on a outside and/or a positive pressure applied on an inside of the receiving base.

14. The method of claim 10, wherein in the fourth step, the receiving opening of the receiving space is closed with the interposition of the second packaging element by the closing element.

15. The method of claim 10, wherein the product received in the packaging is subjected to sterilization together with the first packaging element and/or with the second packaging element and/or with the closing element.

16. The packaging of claim 1, wherein the at least one product is a medical product.

17. The packaging of claim 2, wherein the second packaging element is blister-shaped.

18. The packaging of claim 3, wherein the second packaging element is blister-shaped.

19. The packaging of claim 4, wherein the second packaging element is blister-shaped.

20. The packaging of claim 2, wherein a closing element for fixing the second packaging element on the first packaging element is provided, the closing element being connected with the first packaging element by interposing the second packaging element.

Description

[0021] Further advantages and features of the invention result from the claims and the following description of the figures, in which exemplary embodiments of the invention are explained in detail with reference to the drawings. An exemplary embodiment of the invention is shown in the figures. In particular:

[0022] FIG. 1 shows a perspective exploded view of a packaging arrangement according to the invention,

[0023] FIG. 2 shows a section through the packaging arrangement according to the invention according to FIG. 1 with the product received,

[0024] FIG. 3 shows a section of a packaging made from the packaging arrangement according to FIG. 2.

[0025] FIG. 1 shows a packaging 1 with a packaging arrangement 2 for receiving a medical product 4, for example, such as in particular a hip joint, a dental implant, a bone plate, a bone screw, a spinal column implant, a surgical tool or another medical product individually manufactured, for example by laser sintering. The packaging arrangement 2 has a first packaging element 6, a second packaging element 8 and a closing element 10. The individual components of the packaging arrangement 2 are shown in the aforementioned order and counter to the direction of gravity G from bottom to top.

[0026] The first packaging element 6 is made in the form of a blister made of plastic, such as PET, PE or PP, and is essentially rigid at normal ambient temperature and forms a trough-shaped or blister-shaped receiving space 12, which is delimited by a receiving base 14 and a peripheral wall 16 connected to the receiving base 14. The wall 16 extends vertically upwards, starting from the receiving base 14, and has a collar region 18 at its end facing away from the receiving base 14. The first packaging element 6 forms a receiving opening 20 delimited by the collar region 18 via which the product 4 can be placed on the receiving base 14 in order for the product to be received within the receiving space 12. The receiving base 14 is designed to be elastically deformable.

[0027] In addition, the second packaging element 8 can also be inserted into the receiving space 12 via the receiving opening 20. This second packaging element 8 is also formed by a blister with a trough-shaped deep-drawn region, which is made of a plastic that is essentially dimensionally stable or rigid at normal ambient temperature. The second packaging element 8 forms a deep-drawn plug-in region 24 and a planar deformation region 22 that extends within the plug-in region 24 and is spanned by it. This deformation region 22 is made of a plastic that, when heated above the glass transition temperature or to a deformation temperature in the range of 50° C. to 170° C., in particular 90 to 140° C., is plastically deformable. In comparison to the deformation region 22, the plug-in region 24 is formed from a more heat-resistant plastic.

[0028] In addition, a depression 26 is embedded in the collar region 18 and is designed to complement a peripheral collar 28 of the plug-in region 24. In this way, the second packaging element 8 can be arranged in a predetermined end position within the receiving space 12 with a positive fit such that the collar 28 rests in the depression 26.

[0029] The size of the closing element 10 is adapted to the collar region 18 of the first packaging element 6 so that the second packaging element 8 inserted into the first packaging element 6 can be fixed between the first packaging element 6 and the closing element 10. Furthermore, the closing element 10 serves as a cover for closing the receiving opening 20 and thus for additional protection of the product 4.

[0030] As can be gathered in particular from FIG. 2, support means 30 are provided on the side of the wall 16 facing away from the receiving opening 20, for a stable standing support of the first packaging element 6 on the undersurface U. The support means 30 are part of the wall 16 and can be designed, for example, in the form of a peripheral base or shoulder or in the form of feet, which are divided in sections or are isolated. In the present embodiment, the support means 30 are designed in such a way that they form a standing surface 32 that spans a horizontally extending positioning plane S. Between the receiving base 14 and the standing surface 32, the support means 30 form a deformation region 34 in the manner of a film hinge, which allows additional elastic deformation in the region of the receiving base 14 and thereby the generation of additional elastic restoring forces of the same.

[0031] As can also be seen from FIG. 2, in the unloaded state, the receiving base 14 spans a base plane B, which is arranged offset in the vertical gravitational direction of the packaging arrangement 2 above the positioning plane S. In this way, a free cavity 36 is formed between the base plane B and the positioning plane S, which is delimited by the receiving base 14 and the deformation region 34.

[0032] To produce the finished, closed packaging 1 for the product 4 according to FIG. 3, in a first step the product 4 is placed in the receiving space 12, as illustrated by the arrow S1 in FIG. 2. Subsequently, in a second step S2, the deformation region 22 of the second packaging element 8 is heated by heat input W to the above-mentioned deformation temperature of, in particular, 90 to 140° C., as shown in FIG. 2.

[0033] Thereafter, in a third step, the second packaging element 8 is inserted through the receiving opening 20 into the receiving space 14 in accordance with arrow S3. The heated deformation region 22 comes into contact with the product 4, with a contour being formed on the side of the deformation region 22 which is complementary to the corresponding region of the surface of the product 4. The plastic deformation of the deformation region 22 thus forms a positive fitting receptacle for the corresponding part of the product 4.

[0034] In addition, in the third step S3, the receiving base 14 of the first packaging element 6 is stretched into the cavity 36 when the second packaging element 8 is inserted, as a result of which the receiving base 14 generates elastic restoring forces F, which prestress the product 4 in the direction of the positive fitting reception of the deformation region 22. The product 4 is clamped in a clamping region 38 formed between the receiving base 14 and the deformation region 22. The external forces required for the elastic deformation of the receiving base 14 can, for example, be applied solely via the product 4 inserted into the receiving space 12. As an alternative or in addition to this, it is also possible to apply an external force to the receiving base 14 by applying a negative pressure on the outside and/or an overpressure on the inside. In addition, the receiving base 14 can also be heated before or during the third step S3 in order to achieve improved stretching behavior.

[0035] In a subsequent fourth step, the closing element 10 is connected to the collar region 18 of the first packaging element 6 with the second packaging element 8 being interposed, as shown in FIG. 2 by the arrow S4. The attachment of the closing element 10 fixes the collar 28 of the second packaging element 8 received in the depression 26 in relation to the collar region 18 so that the position of the second packaging element 8 as a whole in relation to the first packaging element 6 is also fixed. In addition, the product 4 clamped in the clamping region 38 between the receiving base 14 and the deformation region 22 is permanently secured in its position.

[0036] In order to be able to fix the closing element 10 to the first packaging element 6, these have sealable plastic materials at least in their contact region. The connection of the closing element 10 to the collar region 18 can be made peelable, so that the packaging 1 can be opened easily and quickly, in particular by hand. As an alternative to the sealed connection, the closing element 10 can also be connected to the collar region 18 by gluing or welding, for example.

[0037] After the packaging 1 has been completed, the packaging arrangement 2 with the product 4 received therein can also be sterilized, for example by means of superheated steam, hot air, ethylene oxide, plasma or gamma radiation or by means of any other known and suitable sterilization method.

[0038] As can be seen from FIG. 3, the product 4 is fixed in position in the finished packaging 1 between the deformation region 22 and the receiving base 14. In addition to the positive fitting reception of the product 4 on the side of the deformation region 22, the product 4 is clamped in place by means of the elastic restoring force or prestressing force F acting against the product 4 or in the direction of the receiving opening 20. The result of the prestressing force F acting on the product 4 is that the product 4 is pressed into positive engagement with the complementarily shaped region of the deformation region 22 and is held stably therein. As a result, even a weakly developed contour on the side of the deformation region 22 is sufficient to be able to be held in a stable position in the clamping region 38.

[0039] It is pointed out that all of the above-described elements and features of the various embodiments of the subject matter according to the invention can be interchanged or combined with one another, provided that an exchange or a combination thereof is not ruled out for technical reasons.