WO2023078768A1 - Packaging of a medical product - Google Patents

Packaging of a medical product Download PDF

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Publication number
WO2023078768A1
WO2023078768A1 PCT/EP2022/080041 EP2022080041W WO2023078768A1 WO 2023078768 A1 WO2023078768 A1 WO 2023078768A1 EP 2022080041 W EP2022080041 W EP 2022080041W WO 2023078768 A1 WO2023078768 A1 WO 2023078768A1
Authority
WO
WIPO (PCT)
Prior art keywords
sterile barrier
medical product
section
sterile
packaging
Prior art date
Application number
PCT/EP2022/080041
Other languages
German (de)
French (fr)
Inventor
Florian Etzel
Christian Huber
Original Assignee
Aesculap 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 Aesculap Ag filed Critical Aesculap Ag
Publication of WO2023078768A1 publication Critical patent/WO2023078768A1/en

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B50/00—Containers, covers, furniture or holders specially adapted for surgical or diagnostic appliances or instruments, e.g. sterile covers
    • A61B50/30—Containers specially adapted for packaging, protecting, dispensing, collecting or disposing of surgical or diagnostic appliances or instruments
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B29—WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
    • B29C—SHAPING OR JOINING OF PLASTICS; SHAPING OF MATERIAL IN A PLASTIC STATE, NOT OTHERWISE PROVIDED FOR; AFTER-TREATMENT OF THE SHAPED PRODUCTS, e.g. REPAIRING
    • B29C64/00—Additive manufacturing, i.e. manufacturing of three-dimensional [3D] objects by additive deposition, additive agglomeration or additive layering, e.g. by 3D printing, stereolithography or selective laser sintering
    • B29C64/30—Auxiliary operations or equipment
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B33—ADDITIVE MANUFACTURING TECHNOLOGY
    • B33Y—ADDITIVE MANUFACTURING, i.e. MANUFACTURING OF THREE-DIMENSIONAL [3-D] OBJECTS BY ADDITIVE DEPOSITION, ADDITIVE AGGLOMERATION OR ADDITIVE LAYERING, e.g. BY 3-D PRINTING, STEREOLITHOGRAPHY OR SELECTIVE LASER SINTERING
    • B33Y10/00—Processes of additive manufacturing
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B33—ADDITIVE MANUFACTURING TECHNOLOGY
    • B33Y—ADDITIVE MANUFACTURING, i.e. MANUFACTURING OF THREE-DIMENSIONAL [3-D] OBJECTS BY ADDITIVE DEPOSITION, ADDITIVE AGGLOMERATION OR ADDITIVE LAYERING, e.g. BY 3-D PRINTING, STEREOLITHOGRAPHY OR SELECTIVE LASER SINTERING
    • B33Y40/00—Auxiliary operations or equipment, e.g. for material handling
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B33—ADDITIVE MANUFACTURING TECHNOLOGY
    • B33Y—ADDITIVE MANUFACTURING, i.e. MANUFACTURING OF THREE-DIMENSIONAL [3-D] OBJECTS BY ADDITIVE DEPOSITION, ADDITIVE AGGLOMERATION OR ADDITIVE LAYERING, e.g. BY 3-D PRINTING, STEREOLITHOGRAPHY OR SELECTIVE LASER SINTERING
    • B33Y70/00—Materials specially adapted for additive manufacturing
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B33—ADDITIVE MANUFACTURING TECHNOLOGY
    • B33Y—ADDITIVE MANUFACTURING, i.e. MANUFACTURING OF THREE-DIMENSIONAL [3-D] OBJECTS BY ADDITIVE DEPOSITION, ADDITIVE AGGLOMERATION OR ADDITIVE LAYERING, e.g. BY 3-D PRINTING, STEREOLITHOGRAPHY OR SELECTIVE LASER SINTERING
    • B33Y80/00—Products made by additive manufacturing
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/56—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor
    • A61B17/58—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor for osteosynthesis, e.g. bone plates, screws, setting implements or the like
    • A61B17/68—Internal fixation devices, including fasteners and spinal fixators, even if a part thereof projects from the skin
    • A61B17/84—Fasteners therefor or fasteners being internal fixation devices
    • A61B17/86—Pins or screws or threaded wires; nuts therefor
    • A61B17/865—Packages or dispensers for bone screws or threaded wires
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B50/00—Containers, covers, furniture or holders specially adapted for surgical or diagnostic appliances or instruments, e.g. sterile covers
    • A61B2050/005—Containers, covers, furniture or holders specially adapted for surgical or diagnostic appliances or instruments, e.g. sterile covers with a lid or cover
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B50/00—Containers, covers, furniture or holders specially adapted for surgical or diagnostic appliances or instruments, e.g. sterile covers
    • A61B2050/005—Containers, covers, furniture or holders specially adapted for surgical or diagnostic appliances or instruments, e.g. sterile covers with a lid or cover
    • A61B2050/0089—Containers, covers, furniture or holders specially adapted for surgical or diagnostic appliances or instruments, e.g. sterile covers with a lid or cover having permanent closure means
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B50/00—Containers, covers, furniture or holders specially adapted for surgical or diagnostic appliances or instruments, e.g. sterile covers
    • A61B50/30—Containers specially adapted for packaging, protecting, dispensing, collecting or disposing of surgical or diagnostic appliances or instruments
    • A61B2050/3014—Containers specially adapted for packaging, protecting, dispensing, collecting or disposing of surgical or diagnostic appliances or instruments waterproof
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B50/00—Containers, covers, furniture or holders specially adapted for surgical or diagnostic appliances or instruments, e.g. sterile covers
    • A61B50/20—Holders specially adapted for surgical or diagnostic appliances or instruments
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/0095—Packages or dispensers for prostheses or other implants
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B29—WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
    • B29C—SHAPING OR JOINING OF PLASTICS; SHAPING OF MATERIAL IN A PLASTIC STATE, NOT OTHERWISE PROVIDED FOR; AFTER-TREATMENT OF THE SHAPED PRODUCTS, e.g. REPAIRING
    • B29C64/00—Additive manufacturing, i.e. manufacturing of three-dimensional [3D] objects by additive deposition, additive agglomeration or additive layering, e.g. by 3D printing, stereolithography or selective laser sintering
    • B29C64/10—Processes of additive manufacturing
    • B29C64/106—Processes of additive manufacturing using only liquids or viscous materials, e.g. depositing a continuous bead of viscous material
    • B29C64/112—Processes of additive manufacturing using only liquids or viscous materials, e.g. depositing a continuous bead of viscous material using individual droplets, e.g. from jetting heads
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B29—WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
    • B29C—SHAPING OR JOINING OF PLASTICS; SHAPING OF MATERIAL IN A PLASTIC STATE, NOT OTHERWISE PROVIDED FOR; AFTER-TREATMENT OF THE SHAPED PRODUCTS, e.g. REPAIRING
    • B29C64/00—Additive manufacturing, i.e. manufacturing of three-dimensional [3D] objects by additive deposition, additive agglomeration or additive layering, e.g. by 3D printing, stereolithography or selective laser sintering
    • B29C64/10—Processes of additive manufacturing
    • B29C64/106—Processes of additive manufacturing using only liquids or viscous materials, e.g. depositing a continuous bead of viscous material
    • B29C64/118—Processes of additive manufacturing using only liquids or viscous materials, e.g. depositing a continuous bead of viscous material using filamentary material being melted, e.g. fused deposition modelling [FDM]
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B29—WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
    • B29C—SHAPING OR JOINING OF PLASTICS; SHAPING OF MATERIAL IN A PLASTIC STATE, NOT OTHERWISE PROVIDED FOR; AFTER-TREATMENT OF THE SHAPED PRODUCTS, e.g. REPAIRING
    • B29C64/00—Additive manufacturing, i.e. manufacturing of three-dimensional [3D] objects by additive deposition, additive agglomeration or additive layering, e.g. by 3D printing, stereolithography or selective laser sintering
    • B29C64/10—Processes of additive manufacturing
    • B29C64/106—Processes of additive manufacturing using only liquids or viscous materials, e.g. depositing a continuous bead of viscous material
    • B29C64/124—Processes of additive manufacturing using only liquids or viscous materials, e.g. depositing a continuous bead of viscous material using layers of liquid which are selectively solidified

Definitions

  • the present disclosure relates to a method for sterile packaging of a medical product.
  • Medical products generally have to be packaged in a sterile manner after they have been manufactured.
  • the packaging must ensure that the medical product is not contaminated or damaged during transport, storage or other handling. In other words, it must be ensured that the medical product does not come into contact with an environment surrounding the packaging until the packaging is intentionally opened by a user. Sterile barriers are used as packaging for this.
  • sterile barriers or sterile packaging are manufactured using conventional manufacturing processes. For example, molded film parts in the form of blisters are produced using molds, these are filled and then sealed with a film, for example.
  • Various molds are required for this, which have different sizes and geometries depending on the product to be packaged.
  • the individual molds are expensive to purchase or manufacture and require a lot of storage space. This results in significant packaging costs.
  • One approach to reducing packaging costs would be to reduce the wall thickness of the packaging and thus save on material. This would have however, the disadvantage that puncture resistance and dimensional stability of the sterile barrier would be reduced.
  • sterile barriers with a universal shape for different medical products.
  • medical products that do not completely fill the sterile barrier could move within it and be damaged in the process.
  • the object and aim of the disclosure is therefore to eliminate or at least reduce the disadvantages of the prior art and to provide a method for sterile packaging of a product that saves on packaging costs.
  • the process for sterile packaging of a medical product includes the following process steps: a. Additive molding of a first section of a sterile barrier b. inserting the medical device into the first segment of the sterile barrier, and c. Additive molding of a second section of the sterile barrier directly onto the first section to create a sterile, closed packaging interior containing the medical product.
  • Molding is to be understood as meaning that shaping or primary shaping/forming of the second part by additive manufacturing processes is directly attached to the first part is done.
  • the second section is built up in layers directly on the first section.
  • forming the second section and connecting the second section to the first section occurs simultaneously.
  • the formation of the second section is in continuity with the first section.
  • the process for sterile packaging of the medical product can be divided into three process steps.
  • a first step the first section of the sterile barrier / sterile packaging is formed using additive manufacturing.
  • the medical product is inserted into the section formed in the first step.
  • the second section is integrally formed onto the first section of the sterile barrier using additive manufacturing.
  • the first section and the second section thus form a one-piece sterile barrier, in particular one piece of material, which completely encloses the medical product.
  • the sterile barrier thus forms a packaging interior that is protected against the ingress of, for example, microorganisms from the environment surrounding the sterile barrier.
  • the essence of the invention is to pack a medical product in a sterile barrier, with the first section of the sterile barrier being additively manufactured, the medical product being placed in the first section and the sterile barrier then being additively completed with the second section.
  • Such a method for the sterile packaging of medical products makes it possible to package the medical product in a sterile barrier without expensive individual molds and to react flexibly to adjustments made to the geometry of the medical product.
  • the first method step of the sterile packaging of the medical product can include forming a product receptacle in the first section, which is provided and formed to receive the medical product.
  • a product receptacle is preferably formed in the first process step of sterile packaging by means of additive manufacturing, which is adapted/matched to a geometry of the medical product and is intended and formed to receive the medical product in particular in a form-fitting manner. This ensures that the medical product cannot move in the sterile barrier during transport or that the medical product does not move relative to the sterile barrier in a packed state.
  • a predetermined breaking point can be formed in an outer wall of the sterile barrier in the method for sterile packaging of the medical product.
  • a particularly linear section is formed in an outer wall of the sterile barrier, which has a smaller wall thickness than the adjacent outer wall and as the predetermined breaking point when opening serves as the sterile barrier.
  • the linear section preferably runs in such a way that it divides the sterile barrier into two sections that can move relative to one another. The provision of such a predetermined breaking point ensures that the sterile barrier can be opened easily and in a controlled manner by a user without the aid of tools.
  • two predetermined breaking points arranged in parallel can be formed on the outer wall of the sterile barrier.
  • a pull tab may be formed between the parallel predetermined breaking points.
  • the tear-off tab preferably has a tear-off handle that allows the user to easily tear open the tear-off tab and thus easily open the sterile barrier.
  • the tear-open tab acts as a connecting element, which connects the two sections that are movable relative to one another in an open state when the sterile barrier is in a closed state.
  • the first part and the second part of the sterile barrier can be formed in one piece of material.
  • the first part and the second part are preferably made of an identical material and are formed in one piece.
  • the medical product can be formed with the sterile barrier in one manufacturing process by means of additive manufacturing.
  • the medical product is preferably formed additively after the first method step in the first section of the sterile barrier.
  • the medical product can be formed at the same time as the sterile barrier.
  • both the structure of the medical product and the structure of the sterile barrier can take place in layers, with layers of the sterile barrier and layers of the medical product, which are in one plane, being produced at the same time.
  • the medical product and the sterile barrier are preferably made of the same material.
  • the medical product can be formed from a material that differs from the material of the sterile barrier, as long as the materials are compatible.
  • the sterile barrier can be formed from a plastic, preferably from polypropylene, from polylactide, from poly-L-lactide or polyethylene terephthalate.
  • the sterile barrier is preferably formed from a thermoplastic. Due to the construction from the thermoplastic, it is possible to integrally form the second section onto the first section.
  • fused deposition modelling, multi-jet modeling or a photopolymer printing process can be used for the additive shaping of the first section of the sterile barrier and the shaping of the second section of the sterile barrier on the first section and/or the additive shaping of the medical product.
  • an additive is preferably used for the formation of the sterile barrier and/or the formation of the medical product Manufacturing process used in which the material is applied by means of a nozzle.
  • the training can be carried out with additive manufacturing processes, which a layered Use melting or sintering of a powder bed.
  • the present invention further relates to a sterile barrier monolithically enclosing a medical product.
  • the sterile barrier is formed in one piece around the medical product.
  • the sterile barrier can be additive.
  • the invention also relates to a sterile-packaged medical product which is packaged using one of the methods described above.
  • FIG. 1a is a perspective view of a closed sterile barrier for packaging a medical product according to a first embodiment.
  • Fig. 1b is a side view of the closed sterile barrier for packaging the medical product according to the first embodiment.
  • FIG. 2a is a perspective view of the opened sterile barrier for packaging the medical product according to the first embodiment.
  • 2b is a side view of the opened sterile barrier for packaging the medical product according to the first embodiment.
  • 3a is a perspective view of a first portion of the sterile barrier for packaging the medical product according to the first embodiment.
  • 3b is a side view of the first section of the sterile barrier for packaging the medical product according to the first embodiment.
  • FIG. 4a is a perspective view of the opened and unfolded sterile barrier for packaging the medical product according to the first embodiment.
  • 4b is a side view of the opened and unfolded sterile barrier for packaging the medical product according to the first embodiment.
  • 5a is a perspective view of a closed sterile barrier for packaging the medical product according to a second embodiment.
  • 5b is a side view of the closed sterile barrier for packaging the medical product according to the second embodiment.
  • 6a is a perspective view of the opened sterile barrier for packaging the medical product according to the second embodiment.
  • 6b is a side view of the opened sterile barrier for packaging the medical product according to the second embodiment.
  • FIG. 7a is a perspective view of the opened and unfolded sterile barrier for packaging the medical product according to the second embodiment.
  • 7b is a side view of the opened and unfolded sterile barrier for packaging the medical product according to the second embodiment.
  • Fig. 1a and Fig. 1b show a closed cuboid sterile barrier 2 in a perspective view (Fig. 1a) and in a side view (Fig. 1b) according to a first embodiment, wherein the sterile barrier 2 is provided and designed, a medical record product.
  • the sterile barrier 2 includes two symmetrical half-shells 4, each with a rectangular base 6, each with two long side walls 8 and two short side walls 10, with the long side walls 8 extending at a right angle on long sides of the rectangular base 6 and the short side walls on extend short sides of the rectangular base 6 at a right angle.
  • the half-shells 4 with the rectangular base area 6, the long side walls 8 and the short side walls 10 are made of one piece of material and are connected to one another by means of a hinge 12 at an edge of the short side walls of the half-shells 4.
  • the hinge 12 is, for example, a film hinge.
  • the half-shells 4 are additionally connected to one another with a tear-off tab 14 on the side walls 8, 10, which are not connected by means of the hinge 12.
  • the tear-off tab 14 is provided with predetermined breaking points in the form of grooves 16 on the side edges at which the tear-off tab 14 is connected to the half-shells 4 .
  • the grooves 16 are areas with a reduced wall thickness, which allow the tear-off tab 14 to be torn out.
  • the tear-open tab 14 In order to be able to grip the tear-open tab 14 better, it is provided with a pull-open handle 18 .
  • the pull tab 18 is formed on an end of the pull tab 14 adjacent the hinge 12 .
  • gripping sections 20 are formed on opposite side surfaces 8 , which facilitate a secure gripping of the sterile barrier 2 .
  • Fig. 2a and Fig. 2b show the opened cuboid sterile barrier 2 in a perspective view (Fig. 2a) or in a side view (Fig. 2b) according to the first embodiment, with the tear-off tab 14 compared to Fig. 1a and Fig. 1b away.
  • the sterile barrier 2 is in FIGS. 2a and 2b open.
  • the two half-shells 4 are connected to the hinge 12 so that they can be folded. In other words, the two half-shells 4 can be folded relative to one another.
  • FIG. 3a and 3b show a first section 22 of the cuboid sterile barrier 2 in a perspective view (FIG. 3a) and in a side view (FIG. 3b) according to the first embodiment.
  • the first section 22 is formed in a first step of the method according to the invention.
  • the first section 22 is designed in one piece, in particular in one piece of material, and includes first sections of the half-shells 4, each with the rectangular base area 6, the long side wall 8 and two short side walls 10.
  • the first sections of the half-shells 4 are connected by means of the hinge 12.
  • a receptacle 24 is provided and formed in an interior space of the packaging formed by the two half-shells 4 .
  • the receptacle 24 has a recess 26 matched to the geometry of the medical product.
  • the receptacle 24 is provided and designed to receive the medical product in the recess 26 in particular in a form-fitting manner.
  • the receptacle 24 is integrally formed with the two half-shells 4 and also includes joints 28 that allow the receptacle 24 to be folded.
  • the receptacle 24 is also in a folded-in state.
  • the first receiving sections 30 rest flat on the inside of the base area 6 of the half-shells 4 .
  • a second receiving section 32 which includes the recess 26, is oriented parallel to the short side walls 10.
  • FIG. The angle between the first receiving sections 30 and the second receiving section 32 is 90 degrees.
  • the medical product to be sterilely packaged can be inserted into the first section 22 shown in FIGS. 3a and 3b.
  • FIG. 4a and 4b show the opened and unfolded sterile barrier 2 in a perspective view (FIG. 4a) and in a side view (FIG. 4b) according to the first embodiment.
  • the half-shells 4 are folded against one another or folded apart in the joint 12 .
  • the half-shells 4 form a V-shape in an unfolded state, with the joint 12 connecting the two Half-shells 4 connects, is located in the top of the V.
  • the receptacle 24 is also in an unfolded state. That is, the first receiving portions 30 and the second receiving portion 32 are uniformly oriented. In other words, the first receiving sections 30 and the second receiving section 32 are in one plane.
  • FIG. 5a and 5b show a closed cuboidal sterile barrier 34 in a perspective view (FIG. 3a) or in a side view (FIG. 3b) according to a second embodiment, the sterile barrier 34 being provided and designed to accommodate a medical product .
  • the sterile barrier 34 includes an upper shell 36 and a lower shell 38 which are designed as cuboid half-shells which are oriented towards one another with their openings. Both the upper shell 36 and the lower shell 38 are designed with a grip section 40 that facilitates a secure grip on the sterile barrier 34 .
  • the upper shell 36 and the lower shell 36 are connected by means of a tear-off tab 42 .
  • the tear-off tab 42 is formed all around in the outer wall of the sterile barrier 34 and forms a connecting section between the upper shell 34 and the lower shell 36. In other words, the tear-off tab 42 is between an edge forming the opening in the upper shell 36 and an edge forming the opening in the lower shell 38 edge formed.
  • the tear-off tab 42 is delimited by two parallel grooves 44 all the way around.
  • the grooves 44 are areas with a reduced wall thickness, which allow the tear-off tab 42 to be torn out. In order to be able to grip the tear-open tab 42 better, it is provided with a pull-open handle 46 .
  • Fig. 6a and Fig. 6b show the opened cuboid sterile barrier 34 in a perspective view (Fig. 3a) or in a side view (Fig. 3b) according to a second embodiment, with the tear-off tab 42 compared to Fig. 5a and Fig. 5b is removed.
  • the sterile barrier 2 is open in FIGS. 6a and 6b.
  • 7a and 7b show the opened cuboid sterile barrier 34 in a perspective view (FIG. 3a) or in a side view (FIG. 3b) according to a second embodiment, with the upper shell 36 and the lower shell 38 being separated from one another.
  • a medical product 48 is formed in the upper shell 36 .
  • the medical device 48 is preferably made of the same material as the sterile barrier 34 and is preferably formed by additive manufacturing during the packaging process.
  • the upper shell 36 and the medical product 48 are connected to one another by a breakaway geometry (not shown).
  • the medical product 48 and the upper shell 36 are formed in one piece and are connected to one another via the demolition geometry, preferably in the form of support structures with a small cross section. It is thus easily possible for the user to use force to separate the upper shell 36 and the medical product from one another.

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  • Engineering & Computer Science (AREA)
  • Manufacturing & Machinery (AREA)
  • Materials Engineering (AREA)
  • Chemical & Material Sciences (AREA)
  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Surgery (AREA)
  • Mechanical Engineering (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Optics & Photonics (AREA)
  • Physics & Mathematics (AREA)
  • Biomedical Technology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Medical Informatics (AREA)
  • Molecular Biology (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Packages (AREA)

Abstract

The invention relates to a method for sterile packaging of a medical product (48), comprising the following method steps: a. additively forming a first portion (22) of a sterile barrier (2), b. inserting the medical product (48) in the first portion (22) of the sterile barrier (2) and c. additively forming a second portion of the sterile barrier (2) onto the first portion (22) in order to create a sterile-closed packaging interior containing the medical product (48).

Description

Verpackung eines medizinischen Produktes Packaging of a medical product
Beschreibung Description
Technisches Gebiet technical field
Die vorliegende Offenbarung betrifft ein Verfahren zum Sterilverpacken eines medizinischen Produktes. The present disclosure relates to a method for sterile packaging of a medical product.
Hintergrund der Offenbarung Background to the Revelation
Medizinische Produkte müssen im Allgemeinen nach ihrer Herstellung steril verpackt werden. Hierbei muss die Verpackung gewährleisten, dass das medizinische Produkt während eines Transports, einer Lagerung oder sonstiger Handhabung nicht kontaminiert oder beschädigt wird. In anderen Worten muss gewährleistet sein, dass das medizinische Produkt erst dann in Kontakt mit einer die Verpackung umgebende Umgebung kommt, wenn die Verpackung durch einen Benutzer vorsätzlich geöffnet wird. Hierfür werden als Verpackung Sterilbarrieren eingesetzt. Medical products generally have to be packaged in a sterile manner after they have been manufactured. The packaging must ensure that the medical product is not contaminated or damaged during transport, storage or other handling. In other words, it must be ensured that the medical product does not come into contact with an environment surrounding the packaging until the packaging is intentionally opened by a user. Sterile barriers are used as packaging for this.
Heutzutage werden Sterilbarrieren oder Sterilverpackungen durch konventionelle Fertigungsverfahren gefertigt. So werden beispielsweise mittels Formwerkzeugen Folienformteile in Form von Blistern hergestellt, diese befüllt und anschließend beispielsweise mit einer Folie versiegelt. Hierfür werden diverse Formwerkzeuge benötigt, die je nach zu verpackendem Produkt unterschiedliche Größen und Geometrien aufweisen. Nowadays, sterile barriers or sterile packaging are manufactured using conventional manufacturing processes. For example, molded film parts in the form of blisters are produced using molds, these are filled and then sealed with a film, for example. Various molds are required for this, which have different sizes and geometries depending on the product to be packaged.
Die individuellen Formwerkzeuge sind kostenintensiv in der Anschaffung bzw. Herstellung und benötigen viel Platz in der Lagerung. Dies resultiert in erheblichen Verpackungskosten. Um die Verpackungskosten zu reduzieren wäre ein Ansatz, die Wandstärke der Verpackung zu reduzieren und damit Material einzusparen. Dies hätte jedoch den Nachteil, dass eine Durchstichsicherheit und eine Formstabilität der Sterilbarriere reduziert wäre. The individual molds are expensive to purchase or manufacture and require a lot of storage space. This results in significant packaging costs. One approach to reducing packaging costs would be to reduce the wall thickness of the packaging and thus save on material. This would have however, the disadvantage that puncture resistance and dimensional stability of the sterile barrier would be reduced.
Alternativ wäre vorstellbar, Sterilbarrieren mit einer universellen Form für unterschiedliche medizinische Produkte zu verwenden. Hierbei ergäbe sich jedoch der Nachteil, dass die Sterilbarriere unnötig groß gestaltet werden müsste, um auch das größte medizinische Produkt welches für die Sterilbarriere vorgesehen ist, aufnehmen zu können. Ferner könnten sich medizinische Produkte, welche die Sterilbarriere nicht vollständig ausfüllen in dieser bewegen und dabei zu Schaden kommen. Alternatively, it would be conceivable to use sterile barriers with a universal shape for different medical products. However, this would result in the disadvantage that the sterile barrier would have to be made unnecessarily large in order to be able to accommodate the largest medical product intended for the sterile barrier. Furthermore, medical products that do not completely fill the sterile barrier could move within it and be damaged in the process.
Zusammenfassung der Offenbarung Summary of Revelation
Aufgabe und Ziel der Offenbarung ist es daher, die Nachteile aus dem Stand der Technik zu beheben oder zumindest zu reduzieren und ein Verfahren zum Sterilverpacken eines Produktes bereitzustellen, das Verpackungskosten einspart. The object and aim of the disclosure is therefore to eliminate or at least reduce the disadvantages of the prior art and to provide a method for sterile packaging of a product that saves on packaging costs.
Die Aufgaben der vorliegenden Offenbarung werden hinsichtlich eines Verfahrens zum Sterilverpacken eines medizinischen Produkts erfindungsgemäß durch Merkmale des Anspruch 1 gelöst. The objects of the present disclosure are achieved according to the invention by features of claim 1 with regard to a method for sterile packaging of a medical product.
Das Verfahren zum Sterilverpacken eines medizinischen Produkts beinhaltet die folgenden Verfahrensschritte: a. Additives Ausformen eines ersten Teilstücks einer Steril barriere b. Einsetzen des medizinischen Produkts in das erste Teilstück der Sterilbarriere und c. Additives Anformen eines zweiten Teilstücks der Sterilbarriere direkt an das erste Teilstück zur Schaffung eines steril-geschlossenen, das medizinische Produkt enthaltenden Verpackungsinnenraums. The process for sterile packaging of a medical product includes the following process steps: a. Additive molding of a first section of a sterile barrier b. inserting the medical device into the first segment of the sterile barrier, and c. Additive molding of a second section of the sterile barrier directly onto the first section to create a sterile, closed packaging interior containing the medical product.
Unter Anformen ist zu verstehen, dass eine Formgebung bzw. ein Urformen/das Ausformen des zweiten Teilstücks durch additive Fertigungsverfahren direkt an das erste Teilstück erfolgt. Anders ausgedrückt erfolgt ein schichtweiser Aufbau des zweiten Teilstücks direkt an das erste Teilstück. In nochmals anderen Worten erfolgt das Ausbilden des zweiten Teilstücks und das Verbinden des zweiten Teilstücks mit dem ersten Teilstück simultan. In nochmals anderen Worten Erfolgt die Ausbildung des zweiten Teilstücks in Kontinuität mit dem ersten Teilstück. Molding is to be understood as meaning that shaping or primary shaping/forming of the second part by additive manufacturing processes is directly attached to the first part is done. In other words, the second section is built up in layers directly on the first section. In other words, forming the second section and connecting the second section to the first section occurs simultaneously. In other words, the formation of the second section is in continuity with the first section.
Anders ausgedrückt lässt sich das Verfahren zum Sterilverpacken des medizinischen Produkts in drei Verfahrensschritte einteilen. In einem ersten Schritt wird mittels additiver Fertigung das erste Teilstück der Sterilbarriere / Sterilverpackung ausgebildet. In einem zweiten Schritt wird das medizinische Produkt in das in dem ersten Schritt ausgebildete Teilstück eingesetzt. In einem dritten Schritt wird mittels additiver Fertigung das zweite Teilstück additiv stoffschlüssig an das erste Teilstück der Sterilbarriere angeformt. Das erste Teilstück und das zweite Teilstück bilden somit eine einstückige, insbesondere stoffeinstückige Sterilbarriere, welche das medizinische Produkt vollumfänglich umschließt. Die Sterilbarriere bildet somit einen Verpackungsinnenraum, der gegen ein Eindringen von beispielsweise Mikroorganismen aus einer die Sterilbarriere umgebenden Umwelt geschützt ist. In other words, the process for sterile packaging of the medical product can be divided into three process steps. In a first step, the first section of the sterile barrier / sterile packaging is formed using additive manufacturing. In a second step, the medical product is inserted into the section formed in the first step. In a third step, the second section is integrally formed onto the first section of the sterile barrier using additive manufacturing. The first section and the second section thus form a one-piece sterile barrier, in particular one piece of material, which completely encloses the medical product. The sterile barrier thus forms a packaging interior that is protected against the ingress of, for example, microorganisms from the environment surrounding the sterile barrier.
Kem der Erfindung ist, ein medizinisches Produkt in einer Sterilbarriere zu verpacken, wobei das erste Teilstück der Sterilbarriere additiv gefertigt wird, das medizinische Produkt in das erste Teilstück eingelegt wird und die Sterilbarriere anschließend mit dem zweiten Teilstück additiv vervollständigt wird. The essence of the invention is to pack a medical product in a sterile barrier, with the first section of the sterile barrier being additively manufactured, the medical product being placed in the first section and the sterile barrier then being additively completed with the second section.
Durch ein solches Verfahren zum Sterilverpacken von medizinischen Produkten ist es möglich, das medizinische Produkt ohne teure individuelle Formwerkzeuge in einer Sterilbarriere zu verpacken und flexibel auf Anpassungen, die an der Geometrie des medizinischen Produkts vorgenommen werden, zu reagieren. Such a method for the sterile packaging of medical products makes it possible to package the medical product in a sterile barrier without expensive individual molds and to react flexibly to adjustments made to the geometry of the medical product.
In einem ersten Aspekt kann der erste Verfahrensschritt des Sterilverpackens des medizinischen Produkts ein Ausbilden einer Produktaufnahme in dem ersten Teilstück beinhalten, die vorgesehen und ausgebildet ist, das medizinische Produkt aufzunehmen. In anderen Worten wird vorzugsweise in dem ersten Verfahrensschritt des Sterilverpackens mittels der additiven Fertigung eine Produktaufnahme ausgebildet, die auf eine Geometrie des medizinischen Produktes angepasst / abgestimmt ist und vorgesehen und ausgebildet ist, das medizinische Produkt insbesondere formschlüssig aufzunehmen. So ist gewährleistet, dass sich das medizinische Produkt bei einem Transport nicht in der Sterilbarriere bewegen kann bzw. sich das medizinische Produkt in einem eingepackten Zustand nicht relativ zu der Sterilbarriere bewegt. In a first aspect, the first method step of the sterile packaging of the medical product can include forming a product receptacle in the first section, which is provided and formed to receive the medical product. In other words, a product receptacle is preferably formed in the first process step of sterile packaging by means of additive manufacturing, which is adapted/matched to a geometry of the medical product and is intended and formed to receive the medical product in particular in a form-fitting manner. This ensures that the medical product cannot move in the sterile barrier during transport or that the medical product does not move relative to the sterile barrier in a packed state.
In einem weiteren Aspekt kann bei dem Verfahren zum Sterilverpacken des medizinischen Produkts eine Sollbruchstelle in einer Außenwandung der Sterilbarriere ausgebildet werden. In a further aspect, a predetermined breaking point can be formed in an outer wall of the sterile barrier in the method for sterile packaging of the medical product.
In anderen Worten wird vorzugsweise bei der additiven Ausbildung des ersten Teilstücks und / oder bei der Ausbildung des zweiten Teilstücks der Sterilbarriere ein insbesondere linienförmiger Abschnitt in einer Außenwandung der Sterilbarriere ausgebildet, welcher eine geringere Wandstärke aufweist als die angrenzende Außenwandung und als die Sollbruchstelle bei einem Öffnen der Sterilbarriere dient. Der linienförmige Abschnitt verläuft vorzugsweise so, dass er die Sterilbarriere in zwei zueinander bewegliche Abschnitte teilt. Durch das Vorsehen einer solchen Sollbruchstelle ist gewährleistet, dass die Sterilbarriere von einem Benutzer problemlos und kontrolliert ohne eine Zuhilfenahme von Werkzeug geöffnet werden kann. In other words, in the additive formation of the first section and/or in the formation of the second section of the sterile barrier, a particularly linear section is formed in an outer wall of the sterile barrier, which has a smaller wall thickness than the adjacent outer wall and as the predetermined breaking point when opening serves as the sterile barrier. The linear section preferably runs in such a way that it divides the sterile barrier into two sections that can move relative to one another. The provision of such a predetermined breaking point ensures that the sterile barrier can be opened easily and in a controlled manner by a user without the aid of tools.
In einem weiteren Aspekt können zwei parallel angeordnete Sollbruchstellen an der Außenwandung der Sterilbarriere ausgebildet werden. Eine Aufreißlasche kann zwischen den parallelen Sollbruchstellen ausgebildet sein. Vorzugsweise weist die Aufreißlasche einen Aufreißgriff auf, der dem Benutzer ein einfaches Aufreißen der Aufreißlasche und damit ein einfaches Öffnen der Sterilbarriere ermöglicht. Die Aufreißlasche fungiert hierbei als ein Verbindungselement, welche die zwei in einem geöffneten Zustand zueinander beweglichen Abschnitte in einem geschlossenen Zustand der Sterilbarriere miteinander verbindet. In a further aspect, two predetermined breaking points arranged in parallel can be formed on the outer wall of the sterile barrier. A pull tab may be formed between the parallel predetermined breaking points. The tear-off tab preferably has a tear-off handle that allows the user to easily tear open the tear-off tab and thus easily open the sterile barrier. In this case, the tear-open tab acts as a connecting element, which connects the two sections that are movable relative to one another in an open state when the sterile barrier is in a closed state.
In einem weiteren Aspekt können bei dem Verfahren das erste Teilstück und das zweite Teilstück der Sterilbarriere stoffeinstückig ausgebildet sein. In anderen Worten bestehen das erste Teilstück und das zweite Teilstück vorzugsweise aus einem identischen Werkstoff und sind an einem Stück ausgebildet. In a further aspect, in the method the first part and the second part of the sterile barrier can be formed in one piece of material. In other words, the first part and the second part are preferably made of an identical material and are formed in one piece.
In einem weiteren Aspekt kann das medizinische Produkt mittels additiver Fertigung in einem Herstellvorgang mit der Sterilbarriere ausgebildet werden. In a further aspect, the medical product can be formed with the sterile barrier in one manufacturing process by means of additive manufacturing.
In anderen Worten wird das medizinische Produkt vorzugsweise additiv nach dem ersten Verfahrensschritt in dem ersten Teilstück der Sterilbarriere ausgebildet. Alternativ kann das medizinische Produkt zeitgleich mit der Sterilbarriere ausgebildet werden. Insbesondere kann sowohl der Aufbau des medizinischen Produktes als auch der Aufbau der Sterilbarriere schichtweise erfolgen, wobei Schichten der Sterilbarriere und Schichten des medizinischen Produktes, welche sich in einer Ebene befinden, zeitgleich hergestellt werden. Vorzugsweise sind das medizinische Produkt und die Sterilbarriere aus demselben Material ausgebildet. Alternativ kann das medizinische Produkt aus einem Material ausgebildet werden, das von dem Material der Sterilbarriere abweicht, so lange die Materialien aufeinander abgestimmt sind. In other words, the medical product is preferably formed additively after the first method step in the first section of the sterile barrier. Alternatively, the medical product can be formed at the same time as the sterile barrier. In particular, both the structure of the medical product and the structure of the sterile barrier can take place in layers, with layers of the sterile barrier and layers of the medical product, which are in one plane, being produced at the same time. The medical product and the sterile barrier are preferably made of the same material. Alternatively, the medical product can be formed from a material that differs from the material of the sterile barrier, as long as the materials are compatible.
In einem weiteren Aspekt kann die Sterilbarriere aus einem Kunststoff, vorzugsweise aus Polypropylen, aus Polylactid, aus Poly-L-Lactid oder Polyethylenterephthalat gebildet werden. In a further aspect, the sterile barrier can be formed from a plastic, preferably from polypropylene, from polylactide, from poly-L-lactide or polyethylene terephthalate.
In anderen Worten ist die Sterilbarriere vorzugsweise aus einem Thermoplast gebildet. Durch den Aufbau aus dem Thermoplast ist es möglich, das zweite Teilstück stoffschlüssig an das erste Teilstück anzuformen. In other words, the sterile barrier is preferably formed from a thermoplastic. Due to the construction from the thermoplastic, it is possible to integrally form the second section onto the first section.
In einem weiteren Aspekt kann für die additive Ausformung des ersten Teilstücks der Sterilbarriere und die Anformung des zweiten Teilstücks der Sterilbarriere an das erste Teilstück und / oder die additive Ausformung des medizinischen Produktes Fused Deposition Modeling, Mulit- Jet Modeling oder ein Photopolymer Druckverfahren verwendet werden. In a further aspect, fused deposition modelling, multi-jet modeling or a photopolymer printing process can be used for the additive shaping of the first section of the sterile barrier and the shaping of the second section of the sterile barrier on the first section and/or the additive shaping of the medical product.
In anderen Worten wird für die Ausbildung der Sterilbarriere und / oder die Ausbildung des medizinischen Produktes vorzugsweise ein additives Fertigungsverfahren verwendet, bei welchem der Werkstoff mittels einer Düse appliziert wird. In other words, an additive is preferably used for the formation of the sterile barrier and/or the formation of the medical product Manufacturing process used in which the material is applied by means of a nozzle.
In einem weiteren Aspekt kann, wenn die Sterilbarriere und das medizinische Produkt schichtweise gleichzeitig ausgebildet werden, wobei Schichten der Sterilbarriere und Schichten des medizinischen Produkts, welche sich in einer Ebene befinden, zeitgleich hergestellt werden, die Ausbildung mit additiven Fertigungsverfahren ausgeführt werden, welche ein schichtweises Aufschmelzen bzw. Sintern eines Pulverbettes nutzen. In a further aspect, if the sterile barrier and the medical product are formed layer by layer at the same time, wherein layers of the sterile barrier and layers of the medical product, which are in one plane, are produced at the same time, the training can be carried out with additive manufacturing processes, which a layered Use melting or sintering of a powder bed.
Die vorliegende Erfindung betrifft weiterhin eine Sterilbarriere, die ein medizinisches Produkt monolitisch einschließt. The present invention further relates to a sterile barrier monolithically enclosing a medical product.
In anderen Worten ist die Sterilbarriere stoffeinstückig um das medizinische Produkt herum ausgebildet. In other words, the sterile barrier is formed in one piece around the medical product.
In einen weiteren Aspekt kann die Sterilbarriere additiv ausgebildet sein. In a further aspect, the sterile barrier can be additive.
Die Erfindung betrifft zudem ein sterilverpacktes medizinisches Produkt, welches nach einem der obenstehenden beschriebenen Verfahren verpackt ist. The invention also relates to a sterile-packaged medical product which is packaged using one of the methods described above.
Kurzbeschreibung der Figuren Brief description of the figures
Fig. 1 a ist eine perspektivische Darstellung einer verschlossenen Sterilbarriere zum Verpacken eines medizinischen Produktes nach einer ersten Ausführungsform. 1a is a perspective view of a closed sterile barrier for packaging a medical product according to a first embodiment.
Fig. 1 b ist eine Seitenansicht der verschlossenen Sterilbarriere zum Verpacken des medizinischen Produktes nach der ersten Ausführungsform. Fig. 1b is a side view of the closed sterile barrier for packaging the medical product according to the first embodiment.
Fig. 2a ist eine perspektivische Ansicht der geöffneten Sterilbarriere zum Verpacken des medizinischen Produktes nach der ersten Ausführungsform. 2a is a perspective view of the opened sterile barrier for packaging the medical product according to the first embodiment.
Fig. 2b ist eine Seitenansicht der geöffneten Sterilbarriere zum Verpacken des medizinischen Produktes nach der ersten Ausführungsform. Fig. 3a ist eine perspektivische Ansicht eines ersten Teilstücks der Sterilbarriere zum Verpacken des medizinischen Produktes nach der ersten Ausführungsform. 2b is a side view of the opened sterile barrier for packaging the medical product according to the first embodiment. 3a is a perspective view of a first portion of the sterile barrier for packaging the medical product according to the first embodiment.
Fig. 3b ist eine Seitenansicht des ersten Teilstücks der Sterilbarriere zum Verpacken des medizinischen Produktes nach der ersten Ausführungsform. 3b is a side view of the first section of the sterile barrier for packaging the medical product according to the first embodiment.
Fig. 4a ist eine perspektivische Ansicht der geöffneten und aufgeklappten Sterilbarriere zum Verpacken des medizinischen Produktes nach der ersten Ausführungsform. 4a is a perspective view of the opened and unfolded sterile barrier for packaging the medical product according to the first embodiment.
Fig. 4b ist eine Seitenansicht der geöffneten und aufgeklappten Sterilbarriere zum Verpacken des medizinischen Produktes nach der ersten Ausführungsform. 4b is a side view of the opened and unfolded sterile barrier for packaging the medical product according to the first embodiment.
Fig. 5a ist eine perspektivische Darstellung einer verschlossenen Sterilbarriere zum Verpacken des medizinischen Produktes nach einer zweiten Ausführungsform. 5a is a perspective view of a closed sterile barrier for packaging the medical product according to a second embodiment.
Fig. 5b ist eine Seitenansicht der verschlossenen Sterilbarriere zum Verpacken des medizinischen Produktes nach der zweiten Ausführungsform. 5b is a side view of the closed sterile barrier for packaging the medical product according to the second embodiment.
Fig. 6a ist eine perspektivische Ansicht der geöffneten Sterilbarriere zum Verpacken des medizinischen Produktes nach der zweiten Ausführungsform. 6a is a perspective view of the opened sterile barrier for packaging the medical product according to the second embodiment.
Fig. 6b ist eine Seitenansicht der geöffneten Sterilbarriere zum Verpacken des medizinischen Produktes nach der zweiten Ausführungsform. 6b is a side view of the opened sterile barrier for packaging the medical product according to the second embodiment.
Fig. 7a ist eine perspektivische Ansicht der geöffneten und aufgeklappten Sterilbarriere zum Verpacken des medizinischen Produktes nach der zweiten Ausführungsform. 7a is a perspective view of the opened and unfolded sterile barrier for packaging the medical product according to the second embodiment.
Fig. 7b ist eine Seitenansicht der geöffneten und aufgeklappten Sterilbarriere zum Verpacken des medizinischen Produktes nach der zweiten Ausführungsform. 7b is a side view of the opened and unfolded sterile barrier for packaging the medical product according to the second embodiment.
Detaillierte Beschreibung der Ausführungsformen Nachstehend werden Ausführungsbeispiele der vorliegenden Offenbarung auf der Basis der zugehörigen Figuren beschrieben. Detailed description of the embodiments Embodiments of the present disclosure will be described below based on the accompanying figures.
Erstes Ausführungsbeispiel First embodiment
Fig. 1a und Fig. 1 b zeigen eine verschlossene quaderförmige Sterilbarriere 2 in einer perspektivischen Ansicht (Fig. 1a) bzw. in einer Seitenansicht (Fig. 1 b) nach einer ersten Ausführungsform, wobei die Sterilbarriere 2 vorgesehen und ausgebildet ist, ein medizinisches Produkt aufzunehmen. Die Sterilbarriere 2 beinhaltet zwei symmetrische Halbschalen 4 mit jeweils einer rechteckigen Grundfläche 6, jeweils zwei langen Seitenwänden 8 und zwei kurzen Seitenwänden 10, wobei sich die langen Seitenwände 8 an langen Seiten der rechteckigen Grundfläche 6 in einem rechten Winkel erstrecken und die kurzen Seitenwände sich an kurzen Seiten der rechteckigen Grundfläche 6 in einem rechten Winkel erstrecken. Die Halbschalen 4 mit der rechteckigen Grundfläche 6, den langen Seitenwände 8 und den kurzen Seitenwänden 10 sind stoffeinstückig ausgebildet und mittels eines Scharniers 12 an einer Kante der kurzen Seitenwände der Halbschalen 4 miteinander verbunden. Bei dem Scharnier 12 handelt es sich beispielsweise um ein Filmscharnier. Die Halbschalen 4 sind zusätzlich mit einer Aufreißlasche 14 an den Seitenwänden 8, 10, miteinander verbunden, welche nicht mittels des Scharniers 12 verbunden sind. Die Aufreißlasche 14 ist an Seitenkanten, an denen die Aufreißlasche 14 mit den Halbschalen 4 verbunden ist, mit Sollbruchstellen in Form von Nuten 16 versehen. Bei den Nuten 16 handelt es sich um Bereiche mit reduzierter Wandstärke, die ein Ausreißen der Aufreißlasche 14 ermöglichen. Um die Aufreißlasche 14 besser greifen zu können, ist diese mit einem Aufreißgriff 18 versehen. Der Aufreißgriff 18 ist an einem Ende der Aufreißlasche 14 ausgebildet, das an das Scharnier 12 angrenzt. An einer Außenseite der Halbschalen 4 sind an gegenüberliegenden Seitenflächen 8 Griffabschnitte 20 ausgebildet, die ein sicheres Greifen der Sterilbarriere 2 erleichtern. Fig. 1a and Fig. 1b show a closed cuboid sterile barrier 2 in a perspective view (Fig. 1a) and in a side view (Fig. 1b) according to a first embodiment, wherein the sterile barrier 2 is provided and designed, a medical record product. The sterile barrier 2 includes two symmetrical half-shells 4, each with a rectangular base 6, each with two long side walls 8 and two short side walls 10, with the long side walls 8 extending at a right angle on long sides of the rectangular base 6 and the short side walls on extend short sides of the rectangular base 6 at a right angle. The half-shells 4 with the rectangular base area 6, the long side walls 8 and the short side walls 10 are made of one piece of material and are connected to one another by means of a hinge 12 at an edge of the short side walls of the half-shells 4. The hinge 12 is, for example, a film hinge. The half-shells 4 are additionally connected to one another with a tear-off tab 14 on the side walls 8, 10, which are not connected by means of the hinge 12. The tear-off tab 14 is provided with predetermined breaking points in the form of grooves 16 on the side edges at which the tear-off tab 14 is connected to the half-shells 4 . The grooves 16 are areas with a reduced wall thickness, which allow the tear-off tab 14 to be torn out. In order to be able to grip the tear-open tab 14 better, it is provided with a pull-open handle 18 . The pull tab 18 is formed on an end of the pull tab 14 adjacent the hinge 12 . On the outside of the half-shells 4 , gripping sections 20 are formed on opposite side surfaces 8 , which facilitate a secure gripping of the sterile barrier 2 .
Fig. 2a und Fig. 2b zeigen die geöffnete quaderförmige Sterilbarriere 2 in einer perspektivischen Ansicht (Fig. 2a) bzw. in einer Seitenansicht (Fig. 2b) nach der ersten Ausführungsform, wobei die Aufreißlasche 14 im Vergleich zu Fig. 1a und Fig. 1 b entfernt ist. Anders ausgedrückt ist die Sterilbarriere 2 in der Fig. 2a und Fig. 2b geöffnet. Die beiden Halbschalen 4 sind mit dem Scharnier 12 klappbar verbunden. Anders ausgedrückt können die beiden Halbschalen 4 relativ zueinander geklappt werden. Fig. 2a and Fig. 2b show the opened cuboid sterile barrier 2 in a perspective view (Fig. 2a) or in a side view (Fig. 2b) according to the first embodiment, with the tear-off tab 14 compared to Fig. 1a and Fig. 1b away. In other words, the sterile barrier 2 is in FIGS. 2a and 2b open. The two half-shells 4 are connected to the hinge 12 so that they can be folded. In other words, the two half-shells 4 can be folded relative to one another.
Fig. 3a und Fig. 3b zeigen ein erstes Teilstück 22 der quaderförmigen Sterilbarriere 2 in einer perspektivischen Ansicht (Fig. 3a) bzw. in einer Seitenansicht (Fig. 3b) nach der ersten Ausführungsform. Das erste Teilstück 22 wird in einem ersten Schritt des erfindungsgemäßen Verfahrens ausgebildet. Das erste Teilstück 22 ist einstückig, insbesondere stoffeinstückig ausgebildet und beinhaltet erste Abschnitte der Halbschalen 4 mit jeweils der rechteckigen Grundfläche 6, der langen Seitenwand 8 und zwei kurzen Seitenwänden 10. Die ersten Abschnitte der Halbschalen 4 sind mittels des Scharniers 12 verbunden. In einem Verpackungsinnenraum, der von den beiden Halbschalen 4 ausgebildet ist, ist eine Aufnahme 24 vorgesehen und ausgebildet. Die Aufnahme 24 weist eine auf die Geometrie des medizinischen Produkts abgestimmte Aussparung 26 auf. Die Aufnahme 24 ist vorgesehen und ausgebildet, das medizinische Produkt in der Aussparung 26 insbesondere formschlüssig aufzunehmen. Die Aufnahme 24 ist stoffschlüssig bzw. einstückig mit den beiden Halbschalen 4 ausgebildet und beinhaltet ferner Gelenke 28, die ein Klappen der Aufnahme 24 ermöglichen. In einem in Fig. 3a und Fig. 3b dargestellten Zustand, in dem die Halbschalen 4 in dem Scharnier 12 eingeklappt sind, befindet sich die Aufnahme 24 ebenfalls in einem eingeklappten Zustand. In diesem eingeklappten Zustand liegen erste Aufnahmeabschnitte 30 an der Innenseite der Grundfläche 6 der Halbschalen 4 flächig an. Ein zweiter Aufnahmeabschnitt 32, welcher die Aussparung 26 beinhaltet, ist parallel zu den kurzen Seitenwänden 10 orientiert. Der Winkel zwischen den ersten Aufnahmeabschnitten 30 und dem zweiten Aufnahmeabschnitt 32 beträgt 90 Grad. In das in Fig. 3a und Fig. 3b dargestellte erste Teilstück 22 kann in dem zweiten erfindungsgemäßen Verfahrensschritt das steril zu verpackende medizinische Produkt eingesetzt werden. 3a and 3b show a first section 22 of the cuboid sterile barrier 2 in a perspective view (FIG. 3a) and in a side view (FIG. 3b) according to the first embodiment. The first section 22 is formed in a first step of the method according to the invention. The first section 22 is designed in one piece, in particular in one piece of material, and includes first sections of the half-shells 4, each with the rectangular base area 6, the long side wall 8 and two short side walls 10. The first sections of the half-shells 4 are connected by means of the hinge 12. A receptacle 24 is provided and formed in an interior space of the packaging formed by the two half-shells 4 . The receptacle 24 has a recess 26 matched to the geometry of the medical product. The receptacle 24 is provided and designed to receive the medical product in the recess 26 in particular in a form-fitting manner. The receptacle 24 is integrally formed with the two half-shells 4 and also includes joints 28 that allow the receptacle 24 to be folded. In a state shown in FIGS. 3a and 3b, in which the half-shells 4 are folded in the hinge 12, the receptacle 24 is also in a folded-in state. In this folded-in state, the first receiving sections 30 rest flat on the inside of the base area 6 of the half-shells 4 . A second receiving section 32, which includes the recess 26, is oriented parallel to the short side walls 10. FIG. The angle between the first receiving sections 30 and the second receiving section 32 is 90 degrees. In the second method step according to the invention, the medical product to be sterilely packaged can be inserted into the first section 22 shown in FIGS. 3a and 3b.
Fig. 4a und Fig. 4b zeigen die geöffnete und aufgeklappte Sterilbarriere 2 in einer perspektivischen Ansicht (Fig. 4a) bzw. in einer Seitenansicht (Fig. 4b) nach der ersten Ausführungsform. Die Halbschalen 4 sind in dem Gelenk 12 gegeneinander verklappt bzw. auseinadergeklappt. In anderen Worten bilden die Halbschalen 4 in einem aufgeklappten Zustand eine V-Form, wobei sich das Gelenk 12, das die beiden Halbschalen 4 verbindet, in der Spitze des V verortet ist. Die Aufnahme 24 befindet sich in ebenfalls in einem aufgeklappten Zustand. Das heißt, die ersten Aufnahmeabschnitte 30 und der zweite Aufnahmeabschnitt 32 sind einheitlich orientiert. In anderen Worten befinden sich die ersten Aufnahmeabschnitte 30 und der zweite Aufnahmeabschnitt 32 in einer Ebene. 4a and 4b show the opened and unfolded sterile barrier 2 in a perspective view (FIG. 4a) and in a side view (FIG. 4b) according to the first embodiment. The half-shells 4 are folded against one another or folded apart in the joint 12 . In other words, the half-shells 4 form a V-shape in an unfolded state, with the joint 12 connecting the two Half-shells 4 connects, is located in the top of the V. The receptacle 24 is also in an unfolded state. That is, the first receiving portions 30 and the second receiving portion 32 are uniformly oriented. In other words, the first receiving sections 30 and the second receiving section 32 are in one plane.
Zweites Ausführungsbeispiel Second embodiment
Fig. 5a und Fig. 5b zeigen eine verschlossene quaderförmige Sterilbarriere 34 in einer perspektivischen Ansicht (Fig. 3a) bzw. in einer Seitenansicht (Fig. 3b) nach einer zweiten Ausführungsform, wobei die Sterilbarriere 34 vorgesehen und ausgebildet ist, ein medizinisches Produkt aufzunehmen. Die Sterilbarriere 34 beinhaltet eine Oberschale 36 und eine Unterschale 38, welche als mit ihrer Öffnung zueinander orientierte quaderförmige Halbschalen ausgebildet sind. Sowohl die Oberschale 36 als auch die Unterschale 38 ist mit einem Griffabschnitt 40 ausgebildet, die ein sicheres Greifen der Sterilbarriere 34 erleichtern. Die Oberschale 36 und die Unterschale 36 sind mittels einer Aufreißlasche 42 verbunden. Die Aufreißlasche 42 ist um laufend in der Außenwandung der Sterilbarriere 34 ausgebildet und bildet einen Verbindungsabschnitt zwischen der Oberschale 34 und der Unterschale 36. In anderen Worten ist die Aufreißlasche 42 zwischen einem die Öffnung der Oberschale 36 ausbildenden Rand und einem die Öffnung der Unterschale 38 ausbildenden Rand ausgebildet. Die Aufreißlasche 42 ist umlaufend von zwei parallelen Nuten 44 begrenzt. Bei den Nuten 44 handelt es sich um Bereiche mit reduzierter Wandstärke, die ein Ausreißen der Aufreißlasche 42 ermöglichen. Um die Aufreißlasche 42 besser greifen zu können, ist diese mit einem Aufreißgriff 46 versehen. 5a and 5b show a closed cuboidal sterile barrier 34 in a perspective view (FIG. 3a) or in a side view (FIG. 3b) according to a second embodiment, the sterile barrier 34 being provided and designed to accommodate a medical product . The sterile barrier 34 includes an upper shell 36 and a lower shell 38 which are designed as cuboid half-shells which are oriented towards one another with their openings. Both the upper shell 36 and the lower shell 38 are designed with a grip section 40 that facilitates a secure grip on the sterile barrier 34 . The upper shell 36 and the lower shell 36 are connected by means of a tear-off tab 42 . The tear-off tab 42 is formed all around in the outer wall of the sterile barrier 34 and forms a connecting section between the upper shell 34 and the lower shell 36. In other words, the tear-off tab 42 is between an edge forming the opening in the upper shell 36 and an edge forming the opening in the lower shell 38 edge formed. The tear-off tab 42 is delimited by two parallel grooves 44 all the way around. The grooves 44 are areas with a reduced wall thickness, which allow the tear-off tab 42 to be torn out. In order to be able to grip the tear-open tab 42 better, it is provided with a pull-open handle 46 .
Fig. 6a und Fig. 6b zeigen die geöffnete quaderförmige Sterilbarriere 34 in einer perspektivischen Ansicht (Fig. 3a) bzw. in einer Seitenansicht (Fig. 3b) nach einer zweiten Ausführungsform, wobei die Aufreißlasche 42 im Vergleich zu Fig. 5a und Fig. 5b entfernt ist. Anders ausgedrückt ist die Sterilbarriere 2 in der Fig. 6a und Fig. 6b geöffnet. Die Oberschale 36 und die Unterschale 38 sind in diesem Zustand voneinander vollständig getrennt. Fig. 7a und Fig. 7b zeigen die geöffnete quaderförmige Sterilbarriere 34 in einer perspektivischen Ansicht (Fig. 3a) bzw. in einer Seitenansicht (Fig. 3b) nach einer zweiten Ausführungsform, wobei die Oberschale 36 und die Unterschale 38 voneinander getrennt sind. In der Oberschale 36 ist ein medizinisches Produkt 48 ausgebildet. Das medizinische Produkt 48 ist vorzugsweise aus dem identischen Werkstoff wie die Sterilbarriere 34 und wurde vorzugsweise während des Verpackungsvorgangs durch additive Fertigung ausgebildet. Die Oberschale 36 und das medizinische Produkt 48 sind durch eine Abbruchgeometrie (nicht dargestellt) miteinander verbunden. In anderen Worten sind das medizinische Produkt 48 und die Oberschale 36 stoffeinstückig ausgebildet und über die Abbruchgeometrie, vorzugsweise in Form von Stützstrukturen mit geringem Querschnitt, miteinander verbunden. Durch eine Kraftaufwendung des Benutzers ist es so leicht möglich, die Oberschale 36 und das medizinische Produkt voneinander zu trennen. Fig. 6a and Fig. 6b show the opened cuboid sterile barrier 34 in a perspective view (Fig. 3a) or in a side view (Fig. 3b) according to a second embodiment, with the tear-off tab 42 compared to Fig. 5a and Fig. 5b is removed. In other words, the sterile barrier 2 is open in FIGS. 6a and 6b. In this state, the upper shell 36 and the lower shell 38 are completely separated from one another. 7a and 7b show the opened cuboid sterile barrier 34 in a perspective view (FIG. 3a) or in a side view (FIG. 3b) according to a second embodiment, with the upper shell 36 and the lower shell 38 being separated from one another. A medical product 48 is formed in the upper shell 36 . The medical device 48 is preferably made of the same material as the sterile barrier 34 and is preferably formed by additive manufacturing during the packaging process. The upper shell 36 and the medical product 48 are connected to one another by a breakaway geometry (not shown). In other words, the medical product 48 and the upper shell 36 are formed in one piece and are connected to one another via the demolition geometry, preferably in the form of support structures with a small cross section. It is thus easily possible for the user to use force to separate the upper shell 36 and the medical product from one another.
Bezugszeichenliste Reference List
2 Sterilbarriere 2 sterile barrier
4 Halbschale 4 half shell
6 (rechteckige) Grundfläche 6 (rectangular) base
8 lange Seitenwand 8 long side panel
10 kurze Seitenwand 10 short side panel
12 Scharnier 12 hinge
14 Aufreißlasche 14 pull tab
16 Nut / Sollbruchstelle 16 groove / predetermined breaking point
18 Aufreißgriff 18 rip handle
20 Griffabschnitt 20 handle section
22 erstes Teilstück 22 first part
24 (Produkt-) Aufnahme 24 (product) recording
26 Aussparung 26 recess
28 Gelenk 28 joint
30 erster Aufnahmeabschnitt 30 first recording section
32 zweiter Aufnahmeabschnitt 32 second recording section
34 Sterilbarriere 34 sterile barrier
36 Oberschale Unterschale Griffabschnitt Aufreißlasche Nut / Sollbruchstelle Aufreißgriff medizinisches Produkt 36 upper shell Lower shell Handle section Tear-off tab Groove / predetermined breaking point Tear-off handle medical product

Claims

Ansprüche Expectations
1. Verfahren zum Sterilverpacken eines medizinischen Produkts (48) mit den folgenden Verfahrensschritten: a. Additives Ausformen eines ersten Teilstücks (22) einer Sterilbarriere (2) b. Einsetzen des medizinischen Produkts (48) in das erste Teilstück (22) der Sterilbarriere (2) und c. Additives Anformen eines zweiten Teilstücks der Sterilbarriere (2) direkt an das erste Teilstück (22) zur Schaffung eines steril-geschlossenen, das medizinische Produkt (48) enthaltenden Verpackungsinnenraums. 1. Method for the sterile packaging of a medical product (48) with the following method steps: a. Additive shaping of a first section (22) of a sterile barrier (2) b. inserting the medical product (48) into the first section (22) of the sterile barrier (2) and c. Additive molding of a second section of the sterile barrier (2) directly onto the first section (22) to create a sterile, closed packaging interior containing the medical product (48).
2. Verfahren nach Anspruch 1 , dadurch gekennzeichnet, dass der erste Verfahrensschritt des Sterilverpackens des medizinischen Produktes (48) ein Ausbilden einer Produktaufnahme (24) in dem ersten Teilstück (22) beinhaltet, welche vorgesehen und ausgebildet ist, das medizinische Produkt (48) aufzunehmen. 2. The method according to claim 1, characterized in that the first method step of sterile packaging of the medical product (48) includes forming a product receptacle (24) in the first section (22), which is provided and designed to hold the medical product (48) record.
3. Verfahren nach Anspruch 1 oder 2, dadurch gekennzeichnet, dass bei dem Verfahren zum Sterilverpacken des medizinischen Produktes (48) eine Sollbruchstelle (44) in einer Außenwandung der Sterilbarriere (2) ausgebildet wird. 3. The method according to claim 1 or 2, characterized in that in the method for sterile packaging of the medical product (48) a predetermined breaking point (44) is formed in an outer wall of the sterile barrier (2).
4. Verfahren nach einem der Ansprüche 1 bis 3, dadurch gekennzeichnet, dass bei dem Verfahren das erste Teilstück (22) und das zweite Teilstück der Sterilbarriere (2) stoffeinstückig ausgebildet sind. 4. The method according to any one of claims 1 to 3, characterized in that in the method the first section (22) and the second section of the sterile barrier (2) are formed in one piece of material.
5. Verfahren nach einem der Ansprüche 1 bis 4, dadurch gekennzeichnet, dass bei dem Verfahren das medizinische Produkt (48) mittels additiver Fertigung in einem Herstellvorgang mit der Sterilbarriere (2) ausgebildet wird. 5. The method according to any one of claims 1 to 4, characterized in that in the method the medical product (48) is formed by means of additive manufacturing in a manufacturing process with the sterile barrier (2).
6. Verfahren nach einem der Ansprüche 1 bis 5, dadurch gekennzeichnet, dass die Sterilbarriere (2) aus einem Kunststoff, vorzugsweise aus Polylactid, aus Poly-L- Lactid oder Polyethylenterephthalat ausgebildet wird. 6. The method according to any one of claims 1 to 5, characterized in that the sterile barrier (2) is formed from a plastic, preferably from polylactide, from poly-L-lactide or polyethylene terephthalate.
7. Verfahren nach einem der Ansprüche 1 bis 6, dadurch gekennzeichnet, dass für die additive Ausformung des ersten Teilstücks (22) der Sterilbarriere (2) und die Anformung des zweiten Teilstücks der Sterilbarriere (2) an das erste Teilstück (22) und / oder die additive Ausformung des medizinischen Produktes (48) Fused Deposition Modeling, Mulit - Jet Modeling oder ein Photopolymer Druckverfahren verwendet wird. 7. The method according to any one of claims 1 to 6, characterized in that for the additive formation of the first section (22) of the sterile barrier (2) and the molding of the second section of the sterile barrier (2) on the first section (22) and / or the additive formation of the medical product (48) fused deposition modeling, multi-jet modeling or a photopolymer printing process is used.
8. Sterilbarriere (2), die ein medizinisches Produkt (48) monolitisch einschließt. 8. Sterile barrier (2) monolithically enclosing a medicinal product (48).
9. Sterilverpacktes medizinisches Produkt, welches nach einem Verfahren gemäß einem der Ansprüche 1 bis 7 verpackt ist. 9. sterile packaged medical product, which is packaged according to a method according to any one of claims 1 to 7.
10. Sterilbarriere (2) welche nach einem Verfahren gemäß einem der Ansprüche 1 bis 7 ausgebildet ist. 10. sterile barrier (2) which is formed by a method according to any one of claims 1 to 7.
PCT/EP2022/080041 2021-11-03 2022-10-27 Packaging of a medical product WO2023078768A1 (en)

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