EP2026710A1

EP2026710A1 - Sterile packaging for a medical article

Info

Publication number: EP2026710A1
Application number: EP07701876A
Authority: EP
Inventors: Simon Scheurer; Reto Aeschlimann
Original assignee: F Hoffmann La Roche AG; Roche Diagnostics GmbH
Current assignee: F Hoffmann La Roche AG; Roche Diagnostics GmbH
Priority date: 2006-06-13
Filing date: 2007-02-13
Publication date: 2009-02-25
Also published as: CN101466323A; US20090152148A1; WO2007143863A1

Abstract

The invention relates to sterile packaging for an insulin infusion set, wherein the infusion set (1) is arranged in a sterile packaging chamber (4) formed by a packaging shell (3) and sealed with a sealing cover (5). The sealing cover (5) is sealed on a flange section (6) of the packaging shell (3) and can be detached from the packaging shell in order to open the packaging chamber (4) along the sealed connection. Next to the packaging chamber (4), the packaging shell (3) provides a separate waste disposal chamber (7) with detents (8). The grip part (9), which supports the guide needle (2) of the infusion set and after use of the infusion set (1) is removed together with the guide needle (2), can be placed in said waste disposal chamber and locked, by means of the detents (8), in a position that prevents people from inadvertently coming into contact with the contaminated guide needle (2). Directly after use of the infusion set (1), the gripping part (9) together with the guide needle (2) can be disposed of safely with ordinary domestic waste, using the original packaging, and thereby the risk of injury is reduced to an absolute minimum, and the cost of supply and waste disposal is reduced.

Description

Sterile packaging of a medical. Article

TECHNICAL AREA

The present invention relates to a method for disposing of a medical article with a needle or blade-like physicality for piercing or cutting into the body of a patient, an application of the method and a sterile packaging of such a medical article according to the preambles of the independent claims.

STATE OF THE ART

Sterile medical articles used for piercing or incising into the body of a patient, e.g. Infusion needles, scalpels,

Ports or infusion sets for insulin pumps are nowadays mostly provided as disposables in sterile packs. This development has led to a significant simplification in the management of such articles, especially in the field of outpatient medicine, but the safe disposal of contaminated after use articles represents a previously unsatisfactorily solved problem which in recent years by the increasing prevalence of diseases such as AIDS has become more explosive. While inadvertently contacting a person with the sterile article while being removed from the package is merely painful and usually renders the article unusable for further use, but does not normally result in any health consequences for the injured person, there is one Injury with a contaminated article increases the risk that dangerous diseases will be transmitted. Accordingly, it is of the utmost importance to design the handling and disposal process in such a way that the injury danger with the contaminated article is kept as low as possible.

According to the prior art, e.g. In medical practices, infusion needles are collected in special collection containers after use and then disposed of together, but with the disadvantage that the contaminated needles are left unattended for an extended period of time, leaving you with a latent risk of infection, e.g. through the air or through any liquid leaking from the sump. In addition, the contaminated needles must be handled once more for final disposal, again causing injury.

US Pat. Nos. 5,293,993 and 4,979,616 disclose disposal containers for used syringes in which the syringes, including the needle, are inserted and permanently protected against irreversible occlusion by them, so that they can be disposed of in normal waste. However, such solutions have the disadvantage that the disposal containers must be procured and farmed separately, which is costly and also carries the risk that temporarily no disposal containers are present, although contaminated syringes would be disposed of. US Pat. No. 6,235,006 discloses catheters having an infusion needle connected at the end, which have arranged around the catheter a protective housing, into which the infusion needle can be drawn in after use and irreversibly latched in a protected position, so that problem-free disposal in normal household waste is possible , However, such a solution is costly and also limited to applications in which arranging a protective housing on the medical article technically possible at all and at the same time not disturbing its intended use. PRESENTATION OF THE INVENTION

It is therefore the object to provide methods and products that do not have the disadvantages of the prior art or at least partially avoid them. This object is achieved by the method and the sterile packaging according to the independent patent claims.

Accordingly, a first aspect of the invention relates to a method of disposing of a medical article having a needle or blade-like physical nature for piercing or incising into the body of a patient, such as a patient. an infusion needle, a scalpel, a port or an infusion set for an insulin pump. Here, the article or at least the needle or blade-like physicality providing part of the article after removal of the sterile article from a package and the intended use of the article or needle-like or blade-like physicality providing part of the article in one of the packaging provided Disposal space introduced and thereby secured simultaneously or subsequently with provided by the packaging securing means against removal from the disposal room, so that an inadvertent Inkontaktkommen of people with the contaminated needle or blade-like corporeality is reliably prevented.

In this way, such medical articles or their parts providing the needle or blade-like physicality can be safely disposed of with the normal waste immediately after use using the original packaging. This has the advantage that it can be dispensed with a problematic intermediate storage and must be handled only once with the contaminated needle or blade-like physicality, which can reduce the risk of injury to an absolute minimum. In addition, results the fact that the sales or supply packaging also forms the disposal packaging at the same time has the advantage that automatically there is always a disposal container adapted to the article without having to be provided separately, which increases the security of the disposal process and the logistics overall, relatively little packaging waste is generated and provided for the disposal and disposal of the article, so that savings can be made on the costs of provision and disposal. In a preferred embodiment of the method, the article or the part of the article which forms the needle-like or blade-like corporeality, after the intended use, is again introduced into a space in the packaging in which it was already arranged during the provision. The demanding disposal space here therefore corresponds to the original packaging space.

In an alternative preferred embodiment of the method, the article or the part of the article which forms the needle-like or blade-like corporeality is, after the intended use, introduced into a space in the packaging in which it was not arranged during the provision. The claimed disposal space in this embodiment is therefore a different space than the original packaging space.

Depending on the article and packaging variant, one or the other embodiment may be more preferable. In a further preferred embodiment of the method, the disposal space for securing the article or the needle or blade-like part of the article against being removed from the disposal space is closed with a securing cover provided by the packaging, it being preferred that the Closure of the sorgungsraumes irreversible, so it is not possible to open the same or only by force or destruction of packaging and / or article elements.

In yet another preferred embodiment of the method, the article or the needle-like or blade-like part of the article is provided for securing against removal from the disposal space during or after introduction into the disposal space in a position in which an unauthorized sighted contacting of persons with the contaminated needle- or blade-like corporeality is not possible with one or more locking elements provided by the packaging, it being preferred that the locking takes place irreversibly, ie not releasing the locking or only by force or force Destruction of packaging and / or article elements is possible.

Depending on the article and packaging variant, one or the other of these embodiments or a combination of both embodiments may be more preferable.

A second aspect of the invention relates to the use of the method according to the first aspect of the invention for the disposal of infusion sets or parts of infusion sets for the subcutaneous delivery of liquid medicaments, preferably insulin, into a person's body. In such applications, the benefits of the invention are particularly evident.

A third aspect of the invention relates to a sterile packaging of a medical article for

Piercing or incising into the body of a patient, which is preferably suitable for use in the method according to the first aspect of the invention. The sterile package comprises a sterile packaged medical article with a needle or blade-like physicality for piercing or incising into the body of a patient arranged in a packaging space formed by a packaging. This packaging space can be opened by hand without tools, so that the article can be removed from the packaging space, possibly with another sterile packaging wrapper surrounding it. The packaging of the sterile packaging is designed such that the medical article or a needle or blade-like physicality providing part of the article after removal of the article from the packaging space and the intended use of the medical article or at least after the intended use of the needle or part of the article providing sounding to the body can thus be introduced into a disposal space formed by the packaging and secured there with securing means formed by the packaging, so that an inadvertent contact of persons with the contaminated needle or blade-like corporeality is not possible. After securing, at least the needle-like or blade-like physicality of the article is no longer accessible, or at least no longer accessible, without specific manipulations in this regard, so that unintentional contact and injury to persons is reliably prevented. It goes without saying that the parts of the packaging surrounding the contaminated needle or blade-like corporeality must be formed so tightly that puncturing or cutting them with this physicality under normal disposal conditions is not possible. By providing medical

Articles with a needle-like or blade-like physicality for piercing or cutting into the body of a patient within such a sterile packaging are automatically provided with a disposal container adapted to the article, without having to be provided separately for this purpose. The medical article or the the needle- or blade-like physicality providing part thereof can be disposed of with the normal household waste directly after the intended use using the original packaging, which has the advantage that can be dispensed with problematic intermediate storage and only once with the Contaminated needle or blade-like physicality must be handled, so that the risk of injury can be reduced to an absolute minimum. In addition, as a further advantage, relatively little packaging waste is generated for the provision and disposal of the article, since the packaging used for the sale and the provision of the article at the same time also serves to dispose of the article. As a result, costs in the provision and disposal can be saved.

In a preferred embodiment of the sterile packaging, the securing means are designed such that the securing of the article introduced into the disposal space or the part of the article providing the needlelike or blade-like physicality is irreversible. This backup can not be canceled or only by force or destruction of packaging and / or article elements. As a result, maximum security against a later incontroverting of persons with the contaminated needle- or blade-like physicality is achieved.

In a further preferred embodiment of the sterile packaging, the packaging space is designed as a sterile space, in contrast to likewise provided embodiments, in which the article is arranged in sterile packaging in a non-sterile packaging space in a secondary packaging. This has the advantage that it can be dispensed with such a previously mentioned secondary packaging, which can save costs and waste. In yet another preferred embodiment of the sterile packaging, the packaging comprises a base part, which forms the packaging space, and a lid part, which closes the packaging space formed by the base part, the lid part being separable without tools, partially or completely separable from the base part or tool-free Enabling a removal of the article from the packaging space. The cover part can thus be destroyed by hand at least to the extent or solve the base part that a trouble-free removal of the sterile article from the packaging space is possible. It is conceivable that the cover part is completely separated from the base part or remains captive attached to a partial separation on the base part, which offers the advantage that this does not have to be disposed of separately.

It is preferred that the disposal space and the securing means are formed by the base part, preferably by integrally forming corresponding Körperlichkeiten with the same. As a result, particularly cost-effective solutions are possible.

Furthermore, in the case of rigid packs whose packaging comprises a base part and a cover part, the connection between the cover part and the base part is designed in such a way that the cover part allows the removal of the article along one or more predetermined separation points without tools from the base part is separable, and preferably in such a way that the connection is irreversibly destroyed in the area of the predetermined separation points. Such sterile packages have the advantage that opened packages can be immediately and unambiguously distinguished from unopened packages, which is of essential importance in the packaging of sterile articles. It is also preferred in sterile packaging, the packaging of which comprises a base part and a cover part, that the cover part is sealed onto a flange part formed by the base part, since good and favorable packaging solutions can be realized by this construction method.

Furthermore, in the case of sterile packaging, the packaging of which comprises a base part and a lid part, it is also advantageous if the base part is formed by injection molding from a thermoplastic or by thermoforming a thermoplastic plastic film. Such bases are inexpensive to manufacture and generate relatively little packaging waste.

It is also preferred in such sterile packages whose packaging comprises a base part and a lid part, that the lid part of a medical paper, a paper-like nonwoven fabric (such as available under the name "Tyvek" from Du Pont) or from a Such lidding materials are particularly well suited for the packaging of sterile medical articles.

In yet another preferred embodiment of the sterile packaging, the disposal space is formed by the original packaging space, in another preferred embodiment the disposal space is formed separately from the packaging space. Depending on the nature of the packaged articles and the execution of the packaging, one or the other embodiment may be particularly preferred.

In yet another preferred embodiment of the sterile packaging, the securing means comprise a securing cover with which the disposal space can be closed after the article or the needle or blade-like part of the article has been introduced, preferably irreversibly, so that a reopening of the same not or only by force or destruction tion of packaging and / or article elements is possible. In this way, a maximum of security against contact of a person with the contaminated needle- or blade-like physicality can be achieved. In the case of embodiments in which the packaging includes a base part and a cover part, it is preferred for the securing cover to be formed integrally with the base part, since this makes possible particularly simple and cost-effective solutions.

In yet another preferred embodiment of the sterile packaging, the securing means according to the invention comprise one or more latching elements with which the article or the part of the article providing the needlelike or blade-like physical appearance during introduction or after introduction into the disposal space a position can be locked in which the contaminated needle- or blade-like physicality is not accessible, so that an inadvertent contacting of persons with the same is reliably prevented. It is particularly preferred if the latching takes place irreversibly, that is to say a cancellation of the

Locking is not possible or only by force or destruction of packaging and / or article elements.

In the case of sterile packaging, the packaging of which comprises a base part and a cover part, it is preferred if the latching elements are formed integrally with the base part, since material-saving and cost-effective solutions can thus be realized.

In yet another preferred embodiment of the sterile package, the article is a disposable article, preferably an infusion set for subcutaneous delivery of a liquid drug, particularly insulin, into the body of a patient. In such sterile packaging embodiments, the advantages of the invention are particularly significant. In yet another preferred embodiment, the sterile package comprises exactly one article, in another preferred embodiment it comprises several articles, in which case it then has a separate disposal space as well as separate securing means for each article.

In the case of the last-mentioned embodiment of the sterile packaging, it is preferred that each article is arranged in a packaging space which can be opened separately.

BRIEF DESCRIPTION OF THE DRAWINGS Further preferred embodiments of the invention will become apparent from the dependent claims and from the following description with reference to the figures. Show:

1 shows a perspective top view of a first sterile packaging according to the invention of an infusion set in the original state;

Fig. 2 is a top perspective view of the sterile package of Fig. 1 after removal of the sealing cap from the packaging tray;

Fig. 3 is a plan view of the empty packaging tray of the sterile package of Fig. 2;

FIG. 4 shows a vertical section through the empty packaging tray along the line A-A in FIG. 3; FIG.

Fig. 5 is a perspective plan view of the packaging tray of FIG. 3 after the locking of the used handle part with guide needle in the disposal room of the same. Fig. 6 is a vertical section along the line

B - B in Fig. 5;

7 shows a perspective plan view of a second sterile packaging according to the invention of an infusion set in the original state; FIG. 8 is a side view of the sterile package of FIG. 7; FIG. FIG. 9 is a top perspective view of the sterile package of FIG. 7 after the protective cover has been opened; FIG.

FIG. 10 is a top perspective view of the sterile package of FIG. 9 after removal of the sealing cap from the packaging tray; FIG.

11 is a perspective top view of the packaging tray of the second sterile packaging according to the invention after the introduction of the used handle part with guide needle into the disposal space; FIG. 12 shows a perspective top view of the packaging tray from FIG. 11 after closing and latching of the protective lid; FIG.

FIG. 13 is a side view of the packaging tray of FIG. 12; FIG. and FIG. 14 shows the detail X from FIG. 13, partially cut away.

WAYS FOR CARRYING OUT THE INVENTION

A first preferred embodiment of the sterile packaging according to the invention is in FIGS. 1 and 2 in perspective once completely and unopened in the original state (FIG. 1) and once after opening by removal _. the sealing lid 5 of the packaging tray 3 shown (Fig. 2). FIGS _. 3 to 6 show the packaging shell 3 _. This sterile packaging both in an empty state, in the plan view (Fig. 3) and in vertical section along the line A - A in Fig. 3 (A), as well as in a ready for disposal state with in the packaging tray. 3 secured handle part 9 with contaminated guide needle 2, in a perspective plan view of the packaging tray (Fig. 5) and in vertical section along the line B - B in Fig. 5 (Figure 6). As can be seen from a combination of these figures, the sterile packaging consists of a packaging, which is formed by a packaging tray 3 and a sealing lid 5, and a sterilized in the United States. Pack 3, 5 packed infusion set 1 for insulin. In this case, the packaging tray 3 forms a packaging space 4 in which the infusion set 1 is accommodated and which in the original state is closed by the sealing lid 5. For this purpose, the sealing lid 5 is sealed onto a flange section 6 formed by the packaging shell 3 such that it can be pulled off the flange section 6 by hand to open the packaging 3, 5, wherein the sealing connection with the flange section 6 is irreversibly destroyed. In addition to the packaging space 4, the packaging shell 3 forms a separate disposal space 7, which in the original state is likewise closed off by the sealing lid 5. As can be seen, two locking lugs 8 formed integrally with the packaging shell 3 are arranged in the disposal space 7, with which the grip part 9 of the infusion set 1, which carries the guide needle 2 and after the application of the infusion set 1 on the body of a patient together with this is removed from the rest, applied part of the infusion set, can be locked in a position in the disposal room 7, in which the infusion needle 2 is inaccessible. This situation is shown in FIGS. 5 and 6. A release of the locking between the locking lugs 8 and the handle part 9 is not possible without tools or only with the use of force, so that an inadvertent contacting and injuring persons with the contaminated guide needle 2 is excluded. In the present embodiment, the packaging tray 3 is made by injection molding of a thermoplastic resin having a thickness of about 1.0 mm, and the sealing lid 5 is made of a nonwoven fabric coated on one side with a sealant adhesive.

A second preferred embodiment of the sterile packaging according to the invention is shown in FIGS. 7 to 10, completely and unopened in the original state in FIGS. 7 to 9 and in open position. In this case, FIGS. 7 and 8 show the sterile packaging with the protective cover 10 closed once in the perspective top view (FIG. 7) and once in the side view (FIG. 8). FIG. 9 shows the sterile packaging with the protective cover 10 open in a perspective plan view, and FIG. 10 after opening by removing the sealing lid 5 from the packaging shell 3, likewise in a perspective plan view. 11 shows a perspective top view of the packaging tray 3 of the sterile packaging after the handle part 9 with contaminated guide needle 2 has been introduced into the packaging space 4, which now serves as a demanding disposal space 4. FIGS. 12 and 13 show the packaging shell 3 containing the handle part 9 with the contaminated guide needle 2 sealed with the protective cover 10 now serving as the protection cover 10 in a condition ready for disposal, once in a perspective plan view (FIG. 12) and once in the side view (Fig.13). Again, the sterile packaging thus consists of a package 3, 5 and a sterile in the package 3, 5 packed infusion set 1 for insulin. Again, the package comprises a packaging tray 3 and a sealing lid 5, but the sealing lid 5 in the state of sale by a wegklappbaren protective cover 10 which is integrally formed with the packaging shell 3 and connected thereto along a hinge bar 13, protected from damage (Figures 7 and 8th) . Again, the packaging tray 3 forms a packaging space 4, in which the infusion set 1 is accommodated and which in the original state is closed by the sealing lid 5. In addition, the sealing lid 5, which, however, is accessible only after the protective cover 10 has been folded away (FIG. 9), is also sealed onto a flange section 6 provided by the packaging shell 3 in such a way that it opens the package 3, 5 can be removed by hand from the flange 6. Here, the sealing connection with the flange 6 is irreversibly destroyed and there are detent openings 11 exposed for later engagement of the protective cover 10 arranged locking projections 12. This situation is shown in FIG. In this embodiment, the packaging tray 3 is formed from a thermoformed PET film having a thickness of 0.7 mm, and the sealing lid 5 again consists of a nonwoven fabric coated on one side with a sealant adhesive. In contrast to the previous exemplary embodiment, the packaging tray 3 does not form an additional disposal space here, but the space 4 previously serving as the packaging space serves as a disposal space 4 for receiving the handle part 9 remote from the applied infusion set after removal and application of the sterile infusion set 1 originally arranged therein After this is introduced into the disposal chamber 4 (see FIG. 11), the protective cover 10, which now serves as a sophisticated securing cover 10, is closed and its latching projections 12 are latched into the latching openings 11, so that the disposal room 4 is securely closed and an inadvertent contacting and injuring persons with the contaminated guide needle 2 located therein is precluded. This situation is illustrated in FIGS. 12 to 14, wherein the latching of the latching lugs 12 in the assigned latching opening 11 in FIG. 14 is shown as detail X from FIG. 13 in partial section.

Claims

A method of disposing of a medical article (1) having a needle or blade-like body (2) for piercing or cutting into the body of a patient after removal thereof from a sterile package (3, 5) comprising the steps of: a) Introducing the article (1) or a part of the article (9) providing needle or blade-like physicality (2) after its intended use into a disposal space (4, 7) formed by the packaging (3) and b) Securing the article (1) or the part of the article (9) providing the needle or blade-like physicality (2) with securing means (8, 10, 11, 12) provided by the packaging (3) against removal from the disposal space (4, 7), such that unintentional contact of persons with the contaminated needle or blade-like physicality (2) is made impossible.

2. The method according to claim 1, characterized in that the article (1) or the needle or blade-like physicality (2) providing part of the article (9) after the intended use in a disposal space (4) is introduced, previously as Packaging space (4) for the sterile article (1) has served.

3. The method according to claim 1, characterized in that the article (1) or the needle or blade-like corporeality (2) providing part of the article (9) after the intended use in a disposal space (7) is introduced, the previously not as packaging space (4) for the sterile article (1) has served.

4. Method according to one of the preceding claims, characterized in that for securing the article (1) or the needle or blade-like physicality (2) providing part of the article (9) against removal from the disposal space (4, 7) of the Disposal space (4, 7) is closed in particular irreversible with a provided by the packaging fuse cover (10).

5. The method according to any one of the preceding claims, characterized in that the article (1) or the needle or blade-like corporeality (2) providing part of the article (9) for securing against removal from the disposal space (4, 7) or after being introduced into the disposal space (4, 7) in a position in which an inadvertent incontroverting of persons with the contaminated needle or blade-like physicality (2) is not possible, in particular irreversibly with one or more of the packaging provided Locking elements (8) is latched.

6. Application of the method according to one of the preceding claims for the disposal of infusion sets or parts of infusion sets for subcutaneous delivery of liquid drugs, in particular insulin, in the body of a person. Sterile packaging of a medical article having a needle or blade-like physicality (2) for piercing or cutting into the body of a patient, in particular for use in the method according to one of claims 1 to 5, comprising a medical article (1) having a needle or blade-like corporeality (2) arranged in a packaging space (4) formed by a packaging (3, 5), which can be opened without tools, in order to allow removal of the article (1) from the packaging space (4), characterized that the sterile packaging is designed such that the medical article (1) or a the needle or blade-like physicality (2) providing part of the article (9) after removal from the packaging space (4) and the intended use such in a disposal space formed by the packaging (4,

7) and can be secured there with securing means (8, 10, 11, 12) formed by the packaging, so that inadvertent incontroverting of persons with the contaminated needle or blade-like corporeality (2) can be precluded.

8. sterile packaging according to claim 7, characterized in that the securing means (8, 10, 11, 12) are designed such that the backup of the disposal space (4, 7) introduced article (1) or the needle or blade-like Corporeality (2) providing part of the article (9) is irreversible.

9. sterile packaging according to one of claims 7 to 8, characterized in that the packaging space

(4) is designed as a sterile room.

10. sterile packaging according to one of claims 7 to 9, characterized in that the packaging comprises a base part (3), which forms the packaging space (4), and a cover part (5) which closes the packaging space (4), wherein the lid part (5) Partially or completely destructible without tools from the base part (3) or tool-free, to allow removal of the article (1) from the packaging space (4).

11. Sterile packaging according to claim 10, characterized in that the disposal space (4, 7) and the securing means (8, 10, 11, 12) from the base part (3) are formed.

12. Sterile packaging according to any one of claims 10 to 11, characterized in that the connection between the cover part (5) and the base part (3) is formed such that the cover part (5) for facilitating removal of the article (1) along the target separating points without tools from the base part (3) can be separated, and in particular that while the connection is irreversibly destroyed in the region of the predetermined separation points.

13. sterile packaging according to one of claims 10 to 12, characterized in that the cover part (5) on one of the base part (3) formed flange (6) is sealed.

14. Sterile packaging according to one of claims 10 to 13, characterized in that the base part (3) is formed by injection molding from a thermoplastic or by thermoforming a thermoplastic plastic film.

15. Sterile packaging according to one of claims 10 to 14, characterized in that the cover part (5) is formed by a medical paper, a paper-like nonwoven fabric or an aluminum foil.

16. sterile packaging according to one of claims 7 to 15, characterized in that the disposal space (4, 7) through the packaging space (4) is formed.

17. sterile packaging according to one of claims 7 to 15, characterized in that the disposal space (7) is formed separately from the packaging space (4).

18. Sterile packaging according to one of the claims

7 to 17, characterized in that the securing means (8, 10, 11, 12) comprise a securing cover (10), by means of which the disposal space (4) after insertion of the article (1) or the needle or blade-like corporeality ( 2) providing part of the article (9) can be closed in particular irreversible.

19. sterile pack according to claim 10 and after

Claim 18, characterized in that the securing cover (10) is formed integrally with the base part (3).

20. sterile package according to one of claims 7 to 19, characterized in that the securing means (8, 10, 11, 12) one or more latching elements (8) um- with which the article (1) or the needle- or blade-like physicality (2) providing part of the article (9) during or after introduction into the disposal space (4, 7) in a position in which an inadvertent contact of Persons with the contaminated needle or blade-like physicality

(2) is not possible, in particular irreversibly latched.

21. Sterile packaging according to claim 10 and claim 20, characterized in that the latching elements (8) are integrally formed with the base part (3).

22. Sterile packaging according to one of claims 7 to 21, characterized in that the article (1) is a disposable article, in particular an infusion set (1) for subcutaneous delivery of insulin into the body of a patient.

23. Sterile packaging according to one of claims 7 to 22, characterized in that it comprises exactly one article (1).

24. Sterile packaging according to one of claims 7 to 22, characterized in that it comprises a plurality of articles (1) and per article (1) has a disposal space (4, 7) and securing means (8, 10, 11, 12).

25. Sterile packaging according to claim 24, characterized in that each article (1) is arranged in a separately openable packaging space (4).