DE102021202647A1 - Medical device and method for manufacturing such a medical device - Google Patents

Abstract

The invention relates to a method for producing a medical product, in particular a syringe, an infusion set or a vein cannula, comprising the steps: assembling the medical product, with at least one manually detachable joint between a barrier element and at least one other component and/or section of the medical product being formed a removable and germ-proof sterile barrier is formed, by means of which a sterile section of the medical product and/or a sterile section to be sterilized is delimited; Sterilizing the medical product, with at least the sterile section being sterilized, and with the sterilization taking place before the assembly, during the assembly and/or after the assembly; Packaging of the assembled and at least partially sterilized medical product. The invention also relates to a medical product manufactured using the method.

Description

The invention relates to a medical product, in particular a syringe, an infusion set or a vein cannula, and a method for producing such a medical product.

Medical products such as syringes, infusion sets or vein cannulas are usually manufactured in sterile packaging.

Various methods for the production of such medical products are known in the prior art, in which, if necessary, an assembly, then a packaging and finally a sterilization takes place.

Packaging often takes place in so-called blister packs, which usually have a transparent plastic molded part with a receiving recess into which the medical product is placed. The receiving recess fitted with the medical product is usually closed with a rear wall made of paper or aluminum foil and sealed against germs by means of a seal formed between the plastic molded part and the rear wall.

In the methods known in the prior art, the medical product is sterilized together with the previously germ-tight sealed packaging. Various methods have become established for this purpose, in particular chemical methods (ethylene oxide) or radiation methods (beta-gamma and X-rays).

The object of the invention is to provide a method and a medical product of the type mentioned at the outset, each of which offers advantages over the prior art.

In order to solve this problem, the invention provides a method with the features of claim 1 and a medical product with the features of claim 7 . Advantageous configurations are the subject matter of the dependent claims. The wording of all claims is incorporated into the description by reference.

The method according to the invention for producing a medical product, in particular a syringe, an infusion set or a vein cannula, has the steps: Assembling the medical product, with at least one manually detachable joint between a barrier element and at least one other component and/or section of the medical product, forming a a removable and germ-proof sterile barrier is formed, by means of which a sterile and/or sterile section of the medical product that is to be sterilized is delimited; Sterilizing the medical product, with at least the sterile section being sterilized, and with the sterilization taking place before the assembly, during the assembly and/or after the assembly; Packaging of the assembled and at least partially sterilized medical product. The invention is based on the finding that methods known in the prior art are often associated with increased sterilization and packaging costs. The increased sterilization effort results from the fact that conventional methods provide for sterilization of the medical product together with the packaging. If the sterilization is carried out using an irradiation method, the radiation must be dosed correspondingly high due to the existing packaging. This entails different disadvantages. The cost of packaging in the state of the art results on the one hand from the necessary size and on the other hand from the necessary quality of the packaging usually used. Customary packaging must be large enough to accommodate the entire medical device and enclose it in a germ-proof manner. This is accompanied by increased effort for production, logistics, warehousing and disposal. Furthermore, packaging used in the prior art must be sufficiently resistant to damage. Otherwise it cannot be guaranteed that the sterile barrier formed by the packaging will remain intact until the medical device is used. If, on the one hand, the packaging is dimensioned to be sufficiently resistant, this can, on the other hand, result in the packaging being difficult for a user to remove. This slows down the use of the medical device. The solution according to the invention eliminates these disadvantages in that—to put it simply—the sterile barrier is not integrated into the packaging, but rather into the medical product itself. This allows sterilization to take place before packaging. Alternatively or additionally, the sterilization can take place during packaging. The sterilization effort required for this is comparatively less, since the medical product is not yet packaged during sterilization. In addition, there is a comparatively reduced packaging effort. For example, the packaging can have smaller dimensions and in particular be designed as partial packaging. This saves material, logistics, storage and disposal costs. In addition, less resistant and less expensive packaging materials can be used, since the packaging does not have to form a sterile barrier. The assembly includes at least the formation of the sterile barrier. The assembly preferably includes further assembly steps in which different components and/or sections of the medical product are joined together will. Assembling can also be referred to as mounting. In order to ensure that the sterile barrier can be removed by a user, the joint is designed to be manually detachable. In order to ensure germ-proof properties of the sterile barrier, the joint connection is made fluid-tight, ie airtight and/or liquid-tight. The barrier element and/or the sterile barrier delimit the at least one sterile section of the medical product. The sterile section is delimited from the environment by means of the barrier element and/or the sterile barrier. In the case of medical products which, for example, have a hollow needle, a volume provided for receiving and/or conducting a fluid and/or a fluid connector, the sterile section comprises at least one of the aforementioned sections. The barrier element can be a protective cap, a peel-off film or the like, for example. The at least one sterile section is sterilized before, during and/or after assembly. Sterilization methods suitable for this purpose are known to the person skilled in the art. Preferably, only the at least one sterile section is sterilized. The medical device is packaged after sterilization. Preferably, no further sterilization occurs after packaging.

In an embodiment of the invention, the at least one joint connection is designed as a fluid-tight plug-in connection, screw connection, adhesive connection and/or predetermined breaking connection. This enables simple assembly of the medical product on the one hand and uncomplicated, simple and/or ergonomic manual release of the joint on the other. As a result, the sterile barrier can be removed with little manual effort before the medical product is used. This can be accompanied by time savings and improved ergonomics.

In a further embodiment of the invention, the at least one sterile section includes multiple surfaces and/or volumes of the medical product, with the sterilization including multiple separate sterilization steps for sterilizing the multiple surfaces and/or volumes. The separate sterilization steps can each be carried out before assembly, during assembly and/or after assembly. For example, a first surface and/or a first volume can be sterilized in a first sterilization step. A second surface and/or a second volume can be sterilized in a second sterilization step. The first sterilization step preferably takes place before the assembly, the second assembly step afterwards or vice versa. The plurality of surfaces can be exterior exterior surfaces or interior interior surfaces of the medical product. The same applies correspondingly with regard to the multiple volumes. In other words, this embodiment of the invention provides for separate sterilization of different areas (surfaces, volumes) of the medical product. This allows the use of different sterilization methods. Alternatively, one and the same sterilization method can be used with different process parameters.

The multiple sterilization steps can thus advantageously be adapted in each case with regard to specific requirements of the area to be sterilized. This embodiment of the invention offers many advantages, particularly in comparison to a conventional “complete” sterilization of the medical product in the packaged state.

In a further embodiment of the invention, the separate sterilization steps are carried out using different sterilization methods, surface irradiation and/or chemical gas sterilization being used in particular. The surface irradiation serves to sterilize at least one surface of the sterile section. Chemical gas sterilization serves to sterilize at least one volume of the sterile section. Both sterilization methods can be integrated comparatively easily into the manufacture of the medical product and can be used, for example, between and/or during different assembly steps. In addition, this embodiment of the invention allows comparatively gentle sterilization of the material.

In a further embodiment of the invention, the medical product that has been assembled and sterilized at least in sections is packaged with packaging that does not have and/or does not form a sterile barrier. The packaging can therefore have a comparatively simple design and/or be made from an inexpensive packaging material. Further costs can be saved as a result.

In a further embodiment of the invention, the medical product that has been assembled and sterilized at least in sections is packed with a partial packaging that only partially encloses the medical product. There are further advantages compared to the complete packaging that is customary in the prior art. For example, the cost of materials for the partial packaging is comparatively lower. In addition, the partially packaged medical product can have comparatively small overall dimensions. This can offer advantages in logistics and warehousing.

The medical product according to the invention is manufactured using the method according to the invention, in particular as a syringe, infusion set or vein cannula, and has at least one detachable joint between at least one barrier element and at least one other component and/or section of the medical product, the joint connection forming a removable and germ-proof sterile barrier , by means of which a sterile sterile section of the medical device is delimited. The solution according to the invention offers advantages with regard to sterilization, packaging and use of the medical product. To avoid repetition, reference is made to the relevant explanations in connection with the method according to the invention. What was said there applies analogously to the medical product according to the invention.

In a further embodiment of the invention, the at least one barrier element has a protective cap, a peel-off film and/or a sealing lip. The peel-off foil and/or the sealing lip are preferably set up for fluid-tight sealing of the protective cap. Alternatively, the peel-off foil and/or the sealing lip can form the barrier element as such. The protective cap can have a particularly advantageous multiple function and can also be set up to protect against puncture injuries, in particular if the medical product is a syringe, an infusion set or a venous cannula. The peel-off film can, for example, be glued onto a border of an inlet and/or outlet opening of the medical product. Alternatively, the peel-off foil can be glued onto a sealing gap formed in particular between the protective cap and the further component and/or section.

In a further embodiment of the invention, at least one joint connection is a fluid-tight plug-in connection, screw connection, adhesive connection and/or predetermined breaking connection. If the barrier element has a protective cap or is designed as such, the protective cap can be placed, screwed and/or glued onto the further component and/or the further section of the medical product. Alternatively, the at least one barrier element can be molded in one piece onto the further component and/or the further section of the medical product, forming the predetermined breaking connection. This, for example, by means of a casting process, in particular by means of injection molding from a plastic material.

In a further embodiment of the invention, the medical product is a syringe, having a syringe barrel and a syringe plunger that is accommodated in the syringe barrel so that it can move axially, the syringe barrel having a distal syringe attachment for connection to a hollow needle, and the barrier element being manually releasably attached to the syringe attachment and underneath it Formation of the removable and germ-proof sterile barrier apparently closed.

In a further embodiment of the invention, the medical device is an infusion set, having a drip chamber with a distal spike, and having an infusion tube connected proximally to the drip chamber with a proximal fluid connector, the spike being covered by a first barrier element, which forms a removable and germ-proof first sterile barrier is detachably attached to the drip chamber, and wherein the fluid connector is covered by a second barrier element which is detachably attached to the fluid connector to form a removable and germ-proof second sterile barrier. The infusion set can also be referred to as an IV set or transfer set.

In a further embodiment of the invention, the medical device is a venous cannula, having a hollow needle and a cannula hub carrying the hollow needle, the hollow needle being covered by a first barrier element which is detachably attached distally to the cannula hub, forming a removable and germ-proof first sterile barrier, and wherein the cannula hub is covered at its proximal end by a second barrier element, which is detachably attached to the cannula hub, forming a removable and germ-proof second sterile barrier. The venous cannula can in particular be designed as an indwelling venous cannula or venipuncture cannula. The venous cannula can also be referred to as an IV catheter.

• 1 zeigt eine schematisch stark vereinfachte Darstellung zur Verdeutlichung einer Ausführungsform eines erfindungsgemäßen Verfahrens zur Herstellung eines erfindungsgemäßen Medizinprodukts,
• 2 in schematisch stark vereinfachter Darstellung ein aus dem Stand der Technik bekanntes Medizinprodukt in Form einer Venenkanüle,
• 3 in schematischer Darstellung eine Ausführungsform eines erfindungsgemäßen Medizinprodukts in Form einer Venenkanüle mit einer ersten und zweiten Sterilbarriere,
• 4 schematisch stark vereinfachte Detaildarstellungen unterschiedlicher Varianten der ersten und/oder zweiten Sterilbarriere,
• 5 die Venenkanüle nach 3 unter zeichnerischer Hervorhebung eines mittels der Sterilbarrieren abgegrenzten Sterilabschnitts,
• 6 in schematischer Darstellung eine aus mehreren gemeinsam teilverpackten Venenkanülen nach 3 gebildete Anordnung,
• 7 eine Variante der Anordnung nach 6,
• 8 in schematischer Darstellung ein aus dem Stand der Technik bekanntes Medizinprodukt in Form eines Infusionssets,
• 9 eine weitere Ausführungsform eines erfindungsgemäßen Medizinprodukts in Form eines Infusionssets mit einer ersten und zweiten Sterilbarriere,
• 10 das Infusionsset nach 9 unter zeichnerischer Hervorhebung eines mittels der Sterilbarrieren abgegrenzten Sterilabschnitts,
• 11 eine schematische Darstellung zur Verdeutlichung eines Verfahrensschritts zur Herstellung des Infusionssets nach den 9 und 10,
• 12 das Infusionsset nach den 9 bis 11 mitsamt einer Teilverpackung,
• 13 in schematischer Darstellung ein weiteres aus dem Stand der Technik bekanntes Medizinprodukt in Form einer Spritze,
• 14 in schematischer Darstellung eine weitere Ausführungsform eines erfindungsgemäßen Medizinprodukts in Form einer Spritze mit einer ersten und zweiten Sterilbarriere,
• 15, 16 Varianten der Ausführungsform nach 14,
• 17 eine schematische Darstellung der Spritze nach den 14 bis 16 unter zeichnerischer Hervorhebung eines mittels der Sterilbarrieren abgegrenzten Sterilabschnitts,
• 18 eine schematische Darstellung zur Verdeutlichung einzelner Schritte des Verfahrens nach 1 bei einer Herstellung der Spritze nach den 14 bis 17,
• 19 eine schematische Darstellung entsprechend 18 zur Verdeutlichung einer Verfahrensvariante,
• 20 eine schematische Darstellung zur Verdeutlichung eines weiteren Verfahrensschritts der Verfahren nach 18 und 19 und
• 21 eine schematische Darstellung zur Verdeutlichung einer Variante des anhand 20 verdeutlichten Verfahrensschritts.

Further advantages and features of the invention result from the claims and from the following description of preferred exemplary embodiments of the invention, which are illustrated with the aid of the drawings.

• 1 shows a schematically greatly simplified representation to clarify an embodiment of a method according to the invention for the production of a medical product according to the invention,
• 2 a highly simplified schematic representation of a medical product known from the prior art in the form of a venous cannula,
• 3 a schematic representation of an embodiment of a medical product according to the invention in the form of a vein cannula with a first and second sterile barrier,
• 4 schematic, highly simplified detailed representations of different variants of the first and/or second sterile barrier,
• 5 the venous cannula 3 with graphic highlighting of a sterile section delimited by the sterile barriers,
• 6 a schematic representation of one of several jointly partially packaged venous cannulas 3 educated arrangement,
• 7 a variant of the arrangement 6 ,
• 8th a schematic representation of a medical product known from the prior art in the form of an infusion set,
• 9 a further embodiment of a medical product according to the invention in the form of an infusion set with a first and second sterile barrier,
• 10 the infusion set 9 with graphic highlighting of a sterile section delimited by the sterile barriers,
• 11 a schematic representation to illustrate a method step for the production of the infusion set according to 9 and 10 ,
• 12 the infusion set after the 9 until 11 together with a partial packaging,
• 13 a schematic representation of another medical device known from the prior art in the form of a syringe,
• 14 a schematic representation of a further embodiment of a medical product according to the invention in the form of a syringe with a first and second sterile barrier,
• 15 , 16 Variants of the embodiment 14 ,
• 17 a schematic representation of the syringe according to the 14 until 16 with graphic highlighting of a sterile section delimited by the sterile barriers,
• 18 a schematic representation to clarify individual steps of the method 1 in a manufacture of the syringe according to 14 until 17 ,
• 19 a schematic representation accordingly 18 to clarify a variant of the procedure,
• 20 a schematic representation to illustrate a further step of the method according to 18 and 19 and
• 21 a schematic representation to illustrate a variant of the basis 20 clarified process step.

According to 1 a method for the production of a medical product is illustrated schematically and in a greatly simplified manner. The method is particularly suitable for the production of a syringe ( 14 until 21 ), an infusion set ( 9 until 12 ) and/or a vein cannula ( 3 until 7 ) suitable. That based 1 The method illustrated includes assembling A, sterilizing S and packaging V. Before the further details of the method are discussed, the medical products manufactured by means of the method in the form of the venous cannula 10, the infusion set 30 and the syringe 50 are first described in more detail.

The venous cannula 10 has a hollow needle 11 and a cannula hub 12 carrying the hollow needle. In this respect, the design, the mode of operation and the purpose of use of the vein cannula 10 are basically known to the person skilled in the art.

The hollow needle 11 is covered by a first barrier element 13 . The barrier element 13 is attached to the cannula attachment 12 by means of a first joint 15 , forming a removable and germ-proof first sterile barrier 17 . In addition, the venous cannula 10 has a second barrier element 14 . The second barrier element 14 is attached to the cannula attachment by means of a second joint 16 and with the formation of a removable and germ-proof second sterile barrier 18 . The first barrier element 13 is attached to the cannula hub 12 at one end and the second barrier element 14 is attached at the other end. In this respect one can also speak of a distal barrier element 13 and a proximal barrier element 14 .

In the embodiment shown, the joint connection 15 is a fluid-tight plug-in connection B1, which is based on FIG 4 is shown pictorially. The fluid-tight plug-in connection B1 can, for example, have a sealing lip (not shown in detail) for fluid-tight sealing of a sealing gap (not designated in detail) between the first barrier element 13 and the cannula hub 12 .

In the case of embodiments that are not shown in more detail in the drawing, the first joint connection can be in the form of a screw connection B2, an adhesive connection B3 and/or a predetermined breaking connection B4. Said connection types B2, B3, B4 are based on 4 again shown pictorially. Accordingly, the first barrier element can be screwed, glued or integrally connected to the cannula hub, forming the predetermined breaking connection.

With regard to the formation of the second joint 16, what was said about the first joint 15 applies analogously.

In the embodiment shown, the first barrier element 13 is designed as a first protective cap 19 . The first protective cap 19 protects against puncture injuries caused by the hollow needle 11 . The second barrier element 14 can accordingly be interpreted as a second protective cap 20 . The second protective cap 20 protects against unwanted proximal contacting of the hollow needle 11. In this respect, both protective caps 19, 20 have an advantageous multiple function. On the one hand, the protective caps 19, 20 form the sterile barriers 17, 18. On the other hand, both protective caps 19, 20 have said protective function.

In the embodiment shown, the first barrier element 13 and the second barrier element 14 or the respective protective cap 19, 20 are made of a plastic material in a dimensionally stable manner. In an embodiment that is not shown in the drawing, the first barrier element and/or the second barrier element can instead be designed to be flexible in shape and/or formed from a film.

A sterile section SA10 of the venous cannula 10 is delimited by means of the first barrier element 13 and the second barrier element 14 and the respective sterile barrier 17, 18 ( 5 ). In other words, the sterile section SA10 is fluid-tight, ie airtight and/or liquid-tight, sealed from the environment.

In the embodiment shown, the sterile section SA10 comprises inner and outer lateral surfaces of the hollow needle 11 (not designated in more detail), a volume enclosed by the first barrier element 13 and a volume enclosed by the second barrier element 14 . For better clarification, the sterile section SA10 is in 5 highlighted with hatching. The same applies with regard to the representations of 10 and 17 .

The infusion set 30 ( 9 ) has a drip chamber 31 with a distal piercing spike 32 and also an infusion tube 33 with a proximal fluid connector 34 . The infusion tube 33 is connected in a fluid-conducting manner to a proximal end of the drip chamber 31 and is equipped with a roller clamp 35 . The design, the mode of operation and the use of the infusion set 30 are known to the person skilled in the art.

The infusion set 30 also has a first barrier element 36 which is detachably attached to the drip chamber 31 by means of a first joint 38 and forming a first sterile barrier 40 . The fluid connector 34 is covered by a second barrier element 37 . The second barrier element 37 is detachably attached to the fluid connector by means of a second joint connection 39 and with the formation of a second sterile barrier 41 . In the present case, the first barrier element 36 is designed as a first protective cap 42 . The second barrier element 37 is accordingly designed as a second protective cap 43 .

With regard to the design and functioning of the first and second barrier element 36, 37 and the first and second joint connection 38, 39, what was said in connection with the venous cannula 10 applies accordingly.

How based 10 is illustrated graphically, the first and second sterile barriers 40, 41 ( 9 ) a sterile section SA30. In other words, the sterile section SA30 is sealed in a fluid-tight manner from the environment by means of the first and second barrier elements 36, 37 and the respective sterile barrier 40, 41. In the embodiment shown, the sterile section SA30 comprises inner and outer surfaces of the piercing spike 32 that are not designated in any more detail, the interior volume of the drip chamber 31 and the infusion tube 33, and sections of the fluid connector 34 that are not designated in any more detail.

The Syringe 50 ( 14 ) has a syringe cylinder 51 and a syringe plunger 52 accommodated in the syringe cylinder 51 so that it can move axially. The syringe barrel 51 is provided with a distal syringe hub 58 adapted for connection to a hollow needle. The design, functioning and use of the syringe 50 are known to those skilled in the art. In an embodiment not shown in the drawing, a cannula is attached to the distal syringe attachment.

The syringe 50 also has a first barrier element 53, by means of which the syringe attachment 58 is openably closed. The first barrier element 53 is attached to the cannula hub 58 and/or distally to the syringe plunger 51 by means of a first joint connection 54 and with the formation of a first sterile barrier 55 .

With regard to the design and functioning of the first barrier element 53, the first joint 54 and the first sterile barrier 55, reference is made to what has been disclosed in connection with the venous cannula 10 and the infusion set 30. What was said there also applies accordingly with regard to the syringe 50.

In the embodiment shown, the syringe cylinder 51 is sealed at its proximal end in a germ-proof manner by means of a joint connection 56 and with the formation of a further sterile barrier 57 in relation to the environment. The difference to the first sterile barrier 55 is the additional sterile barrier 57 not removable but permanent instead. The further joint connection 56 is formed between the syringe barrel 51 and a component 59 . The component 59 forms a kind of separate closure.

Based 15 a syringe 50' is shown, which differs from the syringe 50 only with regard to the formation of the further sterile barrier 57' and the further joint connection 56' 14 differs. The further joint connection 56 ′ is formed between the syringe cylinder 51 and a section 59 ′ of the syringe plunger 52 .

16 shows a syringe 50" as a variant of the syringes 50, 50' according to FIGS 14 and 15 . The syringe 50" differs with regard to the first barrier element 53". This is designed as a peel-off film F. In contrast to this, the first barrier elements 53 of the syringes 50, 50' are each manufactured as a protective cap from a dimensionally stable plastic material.

How based 17 is shown, the syringes 50, 50', 50" each have a sterile section SA50. This is sealed off from the environment by means of the sterile barriers described above Inner and outer surfaces of the cannula hub 58, designated in more detail.

In summary, the medical products 10, 30, 50, 50', 50" have in common that they each have at least one manually detachable joint between at least one barrier element and at least one other component and/or section of the medical product 10, 30, 50, 50', 50 "Have, wherein the joint connection forms a removable and germ-proof sterile barrier, by means of which a sterile sterile section of the medical product 10, 30, 50, 50 ', 50" is delimited.

• Zur Herstellung der Spritze 50 werden der Spritzenzylinder 51 und der Spritzenkolben 52 auf grundsätzlich bekannte Weise assembliert (18). Hierfür werden mehrere Spritzenzylinder 51 entlang einer ersten - in Bezug auf die Zeichenebene der 18 - horizontal orientierten Zuführrichtung und mehrere Spritzenzylinder 52 entlang einer vertikal orientierten Zuführrichtung der Assemblierung zugeführt. Die Spritzenkolben 52 werden jeweils in ein proximales Stirnende eines der Spritzenzylinder 51 eingeführt.

That based 1 generally illustrated method for the production of the medical products 10, 30, 50, 50 ', 50 "is based on the 18 until 21 and with regard to the production of the syringe 50 clarified in more detail:

• To produce the syringe 50, the syringe cylinder 51 and the syringe plunger 52 are assembled in a manner that is basically known ( 18 ). For this purpose, several syringe barrels 51 along a first - with respect to the plane of the 18 - Horizontally oriented feed direction and a plurality of syringe barrels 52 fed along a vertically oriented feed direction of the assembly. The syringe plungers 52 are each inserted into a proximal end face of one of the syringe cylinders 51 .

A first sterilization step S1 takes place before this assembly step, which can also be referred to as an assembly step. In this sterilization step S1, the respective inner volume SA1 of the syringe cylinder 51 is sterilized. In the present case, this is done using a sterilization method that is not specified in more detail and that provides for surface irradiation of the inner surfaces of the syringe barrel 51 . The irradiation is symbolized by the arrows.

In addition, a second sterilization step S2 is provided, in which the respective surfaces SA2 of the syringe plunger 52 are sterilized. The second sterilization step S2 is carried out before the syringe barrel 51 and the syringe plunger 52 are assembled. In the present case, a sterilization method for surface irradiation is used for this purpose. This is again by means of the reference 18 shown arrows.

After inserting the syringe barrel 52 into the syringe plunger 51, the joints 56, 56' and thus the corresponding sterile barriers 57, 57' ( 14 , 15 ) educated. After the assembly, a third sterilization step S3 for sterilizing the cannula attachments 58 is provided. In this case, surfaces SA3 of the cannula attachments 58 are sterilized by means of surface irradiation.

After sterilizing the cannula attachments 58, another assembly step takes place ( 20 ), in which the barrier elements 53 are detachably attached in the area of the cannula attachments. Before this, the inner volumes SA4 of the barrier elements 53 are sterilized in a fourth sterilization step S4. This is also done in the present case by means of surface irradiation.

The respective sterile barrier 54 ( 14 , 15 ) educated.

After the method steps described above, the sterile section SA50 is firstly sterilized and secondly sealed against the environment in a germ-proof manner. The sterile section SA50 includes the previously described sterilized inner volumes SA1, SA4 and surfaces SA2, SA3.

To put it simply, the sterilization S is integrated into the assembly process of the syringe 50 . After assembly A has been completed, the syringe 50 is in a sterilized state that meets the requirements. The structural design of the syringe is 50 as such germ-proof, the barrier element 53 being manually removable before use.

19 12 shows a variant of the method described above, in which the first sterilization step (S1) is carried out using chemical gas sterilization.

21 shows a variant of the method described above, which was used to manufacture the syringe 50" ( 16 ) is provided. In this case, the barrier element 53" is formed by the peel-off film F. Its surface SA4' is sterilized in a fourth sterilization step S4'. The fourth sterilization step S4' can differ from the fourth sterilization step, for example with regard to an irradiation intensity, type of radiation used or the like S4 ( 20 ) differentiate.

The production of the syringe 50 also provides for the aforementioned packaging V, which is based on the 18 until 21 is not further clarified. The packaging V takes place after the assembly A and sterilization S. It is not necessary with regard to the germ-proof and/or sterile nature of the syringe 50 . The packaging V, for example, in a collective or outer packaging together with several other syringes 50 primarily facilitates logistics, warehousing and use of the syringe 50 by the user. Alternatively, the syringes 50 can be partially packaged, for example with a simple banderole or the like.

The difference here is based on 13 a medical product 300 known from the prior art in the form of a syringe 301 packaged sterilely in a blister pack 302, 303 is shown. The blister pack 302, 303 is shown schematically and in a very clear manner and has a design and mode of operation known to those skilled in the art. The blister pack 302, 303 has, in particular, a deep-drawn plastic molded part 302 with a receiving recess, not designated in any more detail, into which the syringe 301 is inserted. The receiving recess is sealed against germs and can be opened by means of a rear wall 303, which is often also referred to as sterile paper. In the case of the medical product 300 known from the prior art, the blister pack 302, 303 forms a sterile barrier. In contrast to the syringe according to the invention, the syringe 301 has no sterile barrier. The syringe 301 is therefore sterilized together with the blister pack 302, 303.

The production of the venous cannula 10 is identical in its essential steps to the production of the syringe 50. After the assembly A and the sterilization S, the venous cannula 10 is in a sterilized state ready for use ( 5 ), In which the venous cannula 10 is not necessarily a package - as based on the 6 and/or 7 - must have.

In contrast to this, a medical product 100 known from the prior art with a vein cannula 101 and a blister pack 102, 103 is shown. The venous cannula 101 has no sterile barrier. This is in turn formed by means of the blister pack 102, 103.

Based on 6 and 7 different packaging TV10, TV10' for packaging the venous cannula 10 are shown. Both packs TV10, TV10' are designed as partial packs without a sterile barrier and are therefore simple and inexpensive in comparison to the blister packs 102, 103.

The packaging TV10 partially encloses several vein cannulas 10 in the area of the respective piercing spike, so that the vein cannulas 10 are connected by means of the packaging TV10. This can facilitate logistics, warehousing and use. The packaging TV10 has a plurality of perforations P for separating the partially packaged venous cannulas 10 .

The packaging TV10' has a basic plate-like shape with a plurality of receiving openings R. The receiving openings R each receive a venous cannula 10, with the respective piercing spike together with the protective cap 19 being inserted into the receiving opening R. The receiving openings R and the protective caps 19 are matched to one another in such a way that the protective caps 19 remain in the receiving opening R when the respective venous cannula 10 is removed.

The production of the infusion set 30 is identical to the production of the syringe 50 and the venous cannula 10 with regard to the essential process steps 11 is shown, the production of the infusion set 30 only provides a single sterilization step S. This is after the assembly, in particular the formation of the sterile barriers 40, 41 ( 9 ), executed. In this case, the roller clamp 35 is aligned in such a way that the radiation emitted for sterilization is impaired as little as possible by the roller of the roller clamp 35, which is not designated in any more detail. As a result, the radiation dose can be set comparatively low. After the sterilization step S, the infusion set 30 is in a sterilized state ready for use, in which at least the sterile section SA30 ( 10 ) is sterilized as required. Again, no packaging is required for this. This is in contrast to a medical product 200 known from the prior art ( 8th ) that in shape an infusion set 201 packaged by means of a blister pack 202, 203. The infusion set 201 itself has no sterile barrier. As with the blister packs 102, 103 and 302, 303, this is formed on the pack side. The infusion set 201 must therefore be packaged completely and before sterilization.

In contrast to this, the infusion set 30 in the present case is only packed with a partial packaging TV30 ( 12 ), which in turn has no sterile barrier.

Claims (12)

Method for producing a medical product (10, 30, 50, 50', 50"), in particular a syringe (50, 50', 50"), an infusion set (30) or a vein cannula (10), having the steps: Assembling (A) the medical product (10, 30, 50, 50', 50"), wherein at least one manually detachable joint (15, 16, 38, 39, 54, 54") between a barrier element (13, 14, 36, 37, 53, 53") and at least one further component and/or section of the medical product (10, 30, 50, 50', 50"), forming a removable and germ-proof sterile barrier (17, 18, 40, 41, 55, 55 ') is formed, by means of which a sterile section (SA10, SA30, SA50) of the medical product (10, 30, 50, 50', 50") and/or a sterile section to be sterilized is delimited; Sterilizing (S) the medical device (10, 30, 50, 50', 50"), wherein at least the sterile section (SA10, SA30, SA50) is sterilized, and wherein the sterilizing (S) before the assembly (A), during the assembling (A) and/or after assembling (A); Packaging (V) of the assembled and at least partially sterilized medical product (10, 30, 50, 50', 50"). procedure after claim 1 , wherein the at least one joint connection (15, 16, 38, 39, 54, 54") is designed as a fluid-tight plug-in connection (B1), screw connection (B2), adhesive connection (B3) and/or predetermined breaking connection (B4). procedure after claim 1 or 2 , characterized in that the at least one sterile section (SA10, SA30, SA50) has several surfaces (SA2, SA3, SA4') and/or volumes (SA1, SA4) of the medical product (10, 30, 50, 50', 50") and wherein the sterilizing (S) comprises multiple separate sterilizing steps (S1, S1', S2, S3, S4, S4') for sterilizing the multiple surfaces (SA2, SA3, SA4') and/or volumes (SA1, SA4). . procedure after claim 3 , characterized in that the separate sterilization steps (S1, S1', S2, S3, S4, S4') are carried out using different sterilization methods, in particular surface irradiation and/or chemical gas sterilization being used. Method according to one of the preceding claims, characterized in that the assembled and at least partially sterilized medical product (10, 30, 50, 50', 50") is packaged with packaging (TV10, TV10', TV30) which has no sterile barrier and /or trains. procedure after claim 5 , characterized in that the medical product (10, 30, 50, 50', 50") that has been assembled and sterilized at least in sections is packed with a partial packaging (TV10, TV10', TV30) which contains the medical product (10, 30, 50, 50 ', 50") only partially enveloped. Medical product (10, 30, 50, 50', 50"), in particular syringe (50, 50', 50"), infusion set (30) or vein cannula (10), having at least one manually detachable joint (15, 16, 38, 39, 54, 54") between at least one barrier element (13, 14, 36, 37, 53, 53") and at least one further component and/or section of the medical product (10, 30, 50, 50', 50"), wherein the joint connection (15, 16, 38, 39, 54, 54") forms a removable and germ-proof sterile barrier (17, 18, 40, 41, 55, 55') by means of which a sterile sterile section (SA10, SA30, SA50) of the medical device (10, 30, 50, 50', 50"). Medical product (10, 30, 50, 50', 50") claim 7 , characterized in that the at least one barrier element (13, 14, 36, 37, 53, 53") has a protective cap (19, 20, 42, 43), a peel-off film (F) and/or a sealing lip. Medical product (10, 30, 50, 50', 50") claim 7 or 8th , characterized in that the at least one joint connection (15, 16, 38, 39, 54, 54") is a fluid-tight plug connection (B1), screw connection (B2), adhesive connection (B3) and/or predetermined breaking connection (B4). Medical device according to one of Claims 7 until 9 , wherein the medical product is a syringe (50, 50', 50"), having a syringe cylinder (51) and a syringe plunger (52) accommodated in the syringe cylinder (51) so that it can move axially, the syringe cylinder (51) having a distal syringe attachment (58) for connection to a hollow needle, and wherein the barrier element (53, 53") can be manually detachably attached to the Syringe attachment (58) is attached and closes the same openable. Medical device according to one of Claims 7 until 9 , wherein the medical product is an infusion set (30), having a drip chamber (31) with a distal piercing spike (32), and having an infusion tube (33) connected proximally to the drip chamber (31) and having a proximal fluid connector (34), the The piercing spike (32) is covered by a first barrier element (36), which is detachably attached to the drip chamber (31) to form a removable and germ-proof first sterile barrier (40), and the fluid connector (34) is covered by a second barrier element (37) is covered, which is detachably attached to the fluid connector (34) to form a removable and germ-proof second sterile barrier (41). Medical device according to one of Claims 7 until 9 , wherein the medical product is a venous cannula (10) having a hollow needle (11) and a cannula attachment (12) carrying the hollow needle (11), the hollow needle (11) being covered by a first barrier element (13) which, forming a removable and germ-proof first sterile barrier (17) is detachably attached distally to the cannula hub (12), and the cannula hub (12) is covered at its proximal end by a second barrier element (14) which forms a removable and germ-proof second sterile barrier ( 18) is detachably attached to the needle hub (12).

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