WO2022194920A1 - Dispositif médical et procédé de fabrication d'un tel dispositif médical - Google Patents

Dispositif médical et procédé de fabrication d'un tel dispositif médical Download PDF

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Publication number
WO2022194920A1
WO2022194920A1 PCT/EP2022/056798 EP2022056798W WO2022194920A1 WO 2022194920 A1 WO2022194920 A1 WO 2022194920A1 EP 2022056798 W EP2022056798 W EP 2022056798W WO 2022194920 A1 WO2022194920 A1 WO 2022194920A1
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WO
WIPO (PCT)
Prior art keywords
medical product
sterile
syringe
barrier
connection
Prior art date
Application number
PCT/EP2022/056798
Other languages
German (de)
English (en)
Inventor
Ralph Geiger
Original Assignee
B. Braun Melsungen Ag
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by B. Braun Melsungen Ag filed Critical B. Braun Melsungen Ag
Publication of WO2022194920A1 publication Critical patent/WO2022194920A1/fr

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/14—Infusion devices, e.g. infusing by gravity; Blood infusion; Accessories therefor
    • A61M5/158—Needles for infusions; Accessories therefor, e.g. for inserting infusion needles, or for holding them on the body
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L2/00—Methods or apparatus for disinfecting or sterilising materials or objects other than foodstuffs or contact lenses; Accessories therefor
    • A61L2/02—Methods or apparatus for disinfecting or sterilising materials or objects other than foodstuffs or contact lenses; Accessories therefor using physical phenomena
    • A61L2/08—Radiation
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L2/00—Methods or apparatus for disinfecting or sterilising materials or objects other than foodstuffs or contact lenses; Accessories therefor
    • A61L2/16—Methods or apparatus for disinfecting or sterilising materials or objects other than foodstuffs or contact lenses; Accessories therefor using chemical substances
    • A61L2/20—Gaseous substances, e.g. vapours
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/14—Infusion devices, e.g. infusing by gravity; Blood infusion; Accessories therefor
    • A61M5/162—Needle sets, i.e. connections by puncture between reservoir and tube ; Connections between reservoir and tube
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L2202/00—Aspects relating to methods or apparatus for disinfecting or sterilising materials or objects
    • A61L2202/10—Apparatus features
    • A61L2202/18—Aseptic storing means
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L2202/00—Aspects relating to methods or apparatus for disinfecting or sterilising materials or objects
    • A61L2202/20—Targets to be treated
    • A61L2202/23—Containers, e.g. vials, bottles, syringes, mail
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L2202/00—Aspects relating to methods or apparatus for disinfecting or sterilising materials or objects
    • A61L2202/20—Targets to be treated
    • A61L2202/24—Medical instruments, e.g. endoscopes, catheters, sharps
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/14—Infusion devices, e.g. infusing by gravity; Blood infusion; Accessories therefor
    • A61M5/158—Needles for infusions; Accessories therefor, e.g. for inserting infusion needles, or for holding them on the body
    • A61M2005/1586—Holding accessories for holding infusion needles on the body
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178—Syringes
    • A61M5/31—Details
    • A61M2005/3117—Means preventing contamination of the medicament compartment of a syringe
    • A61M2005/3118—Means preventing contamination of the medicament compartment of a syringe via the distal end of a syringe, i.e. syringe end for mounting a needle cannula
    • A61M2005/312—Means preventing contamination of the medicament compartment of a syringe via the distal end of a syringe, i.e. syringe end for mounting a needle cannula comprising sealing means, e.g. severable caps, to be removed prior to injection by, e.g. tearing or twisting
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178—Syringes
    • A61M5/31—Details
    • A61M2005/3117—Means preventing contamination of the medicament compartment of a syringe
    • A61M2005/3121—Means preventing contamination of the medicament compartment of a syringe via the proximal end of a syringe, i.e. syringe end opposite to needle cannula mounting end
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2207/00—Methods of manufacture, assembly or production

Definitions

  • 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.
  • 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.
  • 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.
  • 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 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 removable and germ-proof sterile barrier is, by means of which a sterile and / or to be sterilized sterile portion of the medical device 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.
  • packaging used in the prior art must be sufficiently resistant to damage.
  • 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.
  • 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. Assembling can also be referred to as mounting.
  • the joint is designed to be manually detachable. To germ density To ensure the properties of the sterile barrier, the joint is 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.
  • 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.
  • the at least one joint connection is designed as a fluid-tight plug-in connection, screw connection, adhesive connection and/or predetermined breaking connection.
  • 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.
  • 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.
  • 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 be advantageous in each case with regard to specific Requirements of the area to be sterilized can be adjusted. This embodiment of the invention offers many advantages, particularly in comparison to a conventional “complete” sterilization of the medical product in the packaged state.
  • 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.
  • this embodiment of the invention allows comparatively gentle sterilization of the material.
  • 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.
  • 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.
  • a partial packaging that only partially encloses the medical product.
  • 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 in terms of sterilization, packaging and use of the medical product. To avoid repetition, reference is made to the relevant statements in connection with the referenced method according to the invention. What was said there applies analogously to the medical product according to 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.
  • 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.
  • 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.
  • At least one joint connection is a fluid-tight plug-in connection, screw connection, adhesive connection and/or predetermined breaking connection.
  • 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.
  • 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.
  • 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 Training of removable and germ-proof sterile barrier closes openable.
  • 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.
  • 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.
  • Fig. 1 shows a schematically greatly simplified representation to clarify a
  • FIG. 2 shows a medical product known from the prior art in the form of a venous cannula in a highly simplified schematic representation
  • FIG. 3 shows a schematic representation of an embodiment of a device according to the invention
  • Medical product in the form of a vein cannula with a first and second sterile barrier
  • FIG. 4 highly simplified schematic detail representations of different variants of the first and/or second sterile barrier
  • FIG. 5 shows the venous cannula according to FIG.
  • FIG. 6 in a schematic representation of several jointly partially packaged
  • FIG. 7 shows a variant of the arrangement according to Fig. 6,
  • FIG. 8 shows a schematic representation of a medical product known from the prior art in the form of an infusion set
  • FIG. 9 shows 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
  • FIG. 10 shows the infusion set according to FIG. 9 with a sterile section delimited by means of the sterile barriers highlighted
  • FIG. 11 shows a schematic illustration to clarify a method step for producing the infusion set according to FIGS. 9 and 10,
  • FIGS. 9 to 11 shows the infusion set according to FIGS. 9 to 11 together with a partial packaging
  • FIG. 14 shows 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
  • FIG. 17 shows a schematic representation of the syringe according to FIGS. 14 to 16, with a sterile section delimited by means of the sterile barriers being emphasized in the drawing,
  • FIG. 18 shows a schematic representation to clarify individual steps of the method according to FIG. 1 in the production of the syringe according to FIGS. 14 to 17,
  • FIG. 19 shows a schematic representation corresponding to FIG. 18 to illustrate a variant of the method
  • FIGS. 18 and 19 shows a schematic illustration to clarify a further method step of the method according to FIGS. 18 and 19 and Fig. 21 is a schematic representation to illustrate a variant of the basis
  • Fig. 20 clarified method step.
  • FIG. 1 a method for producing a medical product is illustrated schematically and in a greatly simplified manner.
  • the method is particularly suitable for producing a syringe (FIGS. 14 to 21), an infusion set (FIGS. 9 to 12) and/or a vein cannula (FIGS. 3 to 7).
  • the method illustrated with reference to FIG. 1 includes assembling A, sterilizing S and packaging V.
  • 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 described.
  • the venous cannula 10 has a hollow needle 11 and a cannula attachment 12 carrying the hollow needle.
  • 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 hub 12 by means of a first joint 15 , forming a removable and germ-proof first sterile barrier 17 .
  • 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 .
  • the joining connection 15 is a fluid-tight plug-in connection B1, which is shown in the form of a pictogram with reference to FIG.
  • 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 .
  • 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 again shown in the form of pictograms with reference to FIG. Accordingly, the first barrier element can be screwed, glued or integrally connected to the cannula hub, forming the predetermined breaking connection.
  • the second joint 16 what was said about the first joint 15 applies analogously.
  • 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.
  • both protective caps 19, 20 have an advantageous multiple function.
  • the protective caps 19, 20 form the sterile barriers 17, 18.
  • both protective caps 19, 20 have said protective function.
  • 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.
  • 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 as well as the respective sterile barrier 17, 18 (FIG. 5).
  • the sterile section SA10 is fluid-tight, i.e. airtight and/or liquid-tight, sealed from the environment.
  • 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 .
  • the sterile section SA10 is hatched in FIG. 5 . The same applies to the illustrations in FIGS. 10 and 17.
  • the infusion set 30 (FIG. 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 by means of a second barrier element 37 covered.
  • 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 .
  • 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 .
  • the first and second sterile barriers 40, 41 delimit a sterile section SA30.
  • 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.
  • 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 (FIG. 14) has a syringe barrel 51 and a syringe plunger 52 accommodated in the syringe barrel 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.
  • 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 .
  • first barrier element 53 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.
  • the syringe cylinder 51 is sealed at its proximal end by means of a joint connection 56 and with the formation of a further sterile barrier 57 in a germ-proof manner in relation to the environment.
  • the difference to the first sterile barrier 55 is the further sterile barrier 57 not removable, but instead permanent.
  • 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.
  • FIG. 15 shows a syringe 50 ' which differs from the syringe 50 according to FIG. 14 only with regard to the design of the further sterile barrier 57' and the further joint connection 56'.
  • the further joint connection 56 ′ is formed between the syringe cylinder 51 and a section 59 ′ of the syringe plunger 52 .
  • FIG. 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.
  • the first barrier elements 53 of the syringes 50, 50' are each manufactured as a protective cap from a dimensionally stable plastic material.
  • the syringes 50, 50', 50'' each have a sterile section SA50.
  • the sterile section SA50 comprises an inner volume of the syringe cylinder 51, outer surfaces of the syringe plunger 52 and inner and outer surfaces of the cannula attachment 58, which are not designated in any more detail.
  • 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.
  • the syringe barrel 51 and the syringe plunger 52 are assembled in a manner that is basically known (FIG. 18).
  • a plurality of syringe barrels 51 are fed to the assembly along a first horizontally oriented feed direction--relative to the plane of the drawing in FIG. 18--and a plurality of syringe barrels 52 are fed along a vertically oriented feed direction.
  • 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.
  • the respective internal volume SA1 of the syringe cylinder 51 is sterilized.
  • 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.
  • 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.
  • a sterilization method for surface irradiation is used for this purpose. This is in turn symbolized by the arrows shown with reference to FIG.
  • a third sterilization step S3 for sterilizing the cannula attachments 58 is provided.
  • surfaces SA3 of the cannula attachments 58 are sterilized by means of surface irradiation.
  • FIG. 20 After the cannula attachments 58 have been sterilized, there is a further assembly step (FIG. 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 (FIGS. 14, 15) is formed by the detachable, fluid-tight attachment of the barrier elements 53 .
  • 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.
  • FIG. 19 shows a variant of the method described above, in which the first sterilization step (S1) is carried out using chemical gas sterilization.
  • FIG. 21 shows a variant of the above-described method intended for manufacturing the syringe 50'' (FIG. 16).
  • 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 S4 (FIG. 20), for example with regard to an irradiation intensity, type of radiation used or the like.
  • the production of the syringe 50 also provides for the packaging V already mentioned, which is not illustrated in any more detail with reference to FIGS. 18 to 21.
  • 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.
  • the syringes 50 can be partially packaged, for example with a simple banderole or the like.
  • a medical product 300 known from the prior art in the form of a syringe 301 packed in a sterile blister pack 302, 303 is shown with reference to FIG.
  • 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.
  • the blister pack 302, 303 forms a sterile barrier.
  • the syringe 301 has no sterile barrier. The syringe 301 is therefore sterilized together with the blister pack 302, 303.
  • the manufacture of the venous cannula 10 is identical in its essential steps to the manufacture of the syringe 50. After assembling A and sterilizing S, the venous cannula 10 is in a sterilized state ready for use (FIG. 5), in which the venous cannula 10 is not necessarily a Packaging - must have - as shown in FIG. 6 and/or 7.
  • 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.
  • Different packaging TV10, TV10' for packaging the venous cannula 10 is shown on the basis of FIGS. Both packs TV10, TV10' are designed as partial packs without a sterile barrier and are therefore simple and inexpensive compared 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 several 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. As is shown with reference to FIG. This is carried out after the assembly, in particular the formation of the sterile barriers 40, 41 (FIG. 9). 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 the sterile section SA30 (FIG. 10) is sterilized as required.
  • FIG. 8 a medical product 200 (FIG. 8) known from the prior art, which is designed in the form of an infusion set 201 packaged by means of a blister pack 202, 203.
  • the infusion set 201 itself has no sterile barrier.
  • the infusion set 201 must therefore be packaged completely and before sterilization.
  • the infusion set 30 in the present case is only packed with a partial packaging TV30 (FIG. 12), which in turn has no sterile barrier whatsoever.

Abstract

L'invention concerne un procédé de fabrication d'un produit médical, en particulier d'une seringue, d'un ensemble de perfusion ou d'une canule veineuse, ledit procédé comprenant les étapes suivantes : assembler le dispositif médical, au moins une liaison d'assemblage qui peut être détachée manuellement étant formée entre un élément barrière et au moins un autre élément et/ou une partie du produit médical, de manière à former une barrière stérile amovible et étanche aux germes, au moyen de laquelle une partie stérile et/ou à stériliser du produit médical est délimitée; stériliser le produit médical, au moins la partie stérile étant stérilisée, et la stérilisation s'effectuant avant l'assemblage, pendant l'assemblage et/ou après l'assemblage, emballer le produit médical assemblé et stérilisé au moins par endroits. L'invention concerne en outre un produit médical fabriqué au moyen du procédé.
PCT/EP2022/056798 2021-03-18 2022-03-16 Dispositif médical et procédé de fabrication d'un tel dispositif médical WO2022194920A1 (fr)

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DE102021202647.8A DE102021202647A1 (de) 2021-03-18 2021-03-18 Medizinprodukt und Verfahren zur Herstellung eines solchen Medizinprodukts

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Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP0227401A2 (fr) * 1985-12-20 1987-07-01 Mallinckrodt, Inc. (a Delaware corporation) Méthode de production de seringues préremplies, stériles en plastic
EP0597220A2 (fr) * 1992-11-06 1994-05-18 B. Braun Melsungen Ag Dispositif médical de transfert
WO2002005188A1 (fr) * 2000-07-07 2002-01-17 Vasca, Inc. Appareil et necessaires de verrouillage et de desinfection des catheters implantes
DE102004040969A1 (de) * 2004-08-24 2006-03-02 Schering Ag Kolben für eine Spritze und Spritze
EP3248620A1 (fr) * 2016-05-25 2017-11-29 Teleflex Life Sciences Procédé de fabrication d'un ensemble de cathéter prêt à l'emploi et ensemble de cathéter prêt à l'emploi

Family Cites Families (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
DE19652708C2 (de) 1996-12-18 1999-08-12 Schott Glas Verfahren zum Herstellen eines befüllten Kunststoff-Spritzenkorpus für medizinische Zwecke
DE20016069U1 (de) 2000-09-16 2000-12-14 Plachky Michael Vorgefüllte sterile Einwegspritze mit gebrauchsfertiger Injektionslösung
DE20214010U1 (de) 2002-09-11 2002-11-07 Disetronic Licensing Ag Medizinische Durchlassvorrichtung zur subkutanen Injektion

Patent Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP0227401A2 (fr) * 1985-12-20 1987-07-01 Mallinckrodt, Inc. (a Delaware corporation) Méthode de production de seringues préremplies, stériles en plastic
EP0597220A2 (fr) * 1992-11-06 1994-05-18 B. Braun Melsungen Ag Dispositif médical de transfert
WO2002005188A1 (fr) * 2000-07-07 2002-01-17 Vasca, Inc. Appareil et necessaires de verrouillage et de desinfection des catheters implantes
DE102004040969A1 (de) * 2004-08-24 2006-03-02 Schering Ag Kolben für eine Spritze und Spritze
EP3248620A1 (fr) * 2016-05-25 2017-11-29 Teleflex Life Sciences Procédé de fabrication d'un ensemble de cathéter prêt à l'emploi et ensemble de cathéter prêt à l'emploi

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