Medical device component

Abstract

In one aspect the present disclosure relates to a medical device component (50) comprising: a molded body (51), wherein the molded body (51) comprises a first molding material (52) and wherein the first molding material (52) comprises cellulose fibers and a binder. In another aspect the present disclosure relates to a medical device or to an injection device comprising such a device component and to a method of manufacturing such a medical device component (50).

Description

[0001] Medical Device Component

[0002] Description

[0003] Field

[0004] The present disclosure relates to the field of medical device components and respective medical devices comprising such components and in particular to drug delivery devices such as syringes, safety syringes or hand-held pen-type injectors. The disclosure further relates to a method of manufacturing medical device components.

[0005] Background

[0006] Drug delivery devices for setting and dispensing a single or multiple doses of a liquid medicament are as such well-known in the art. Generally, such devices have substantially a similar purpose as that of an ordinary syringe.

[0007] Drug delivery devices, such as pen-type injectors, have to meet a number of user-specific requirements. For instance, with patients suffering chronic diseases, such as diabetes, the patient may be physically infirm and may also have impaired vision. Suitable drug delivery devices especially intended for home medication therefore need to be robust in construction and should be easy to use. Furthermore, manipulation and general handling of the device and its components should be intelligible and easy understandable. Such injection devices should provide setting and subsequent dispensing of a dose of a medicament of equal or variable size. Moreover, a dose setting as well as a dose dispensing procedure must be easy to operate and has to be unambiguous.

[0008] Some drug delivery or injection devices provide selecting of a dose of a medicament of variable size and subsequent injecting of the dose previously set. Other injection devices provide setting and dispensing of a fixed dose. Here, the amount of medicament that should be injected in accordance to a given prescription schedule is always the same and does not change or cannot be changed over time.

[0009] Some injection devices are implemented as reusable injection devices offering a user to replace a medicament container, such as a cartridge. Other injection devices are implemented as a disposable injection device. With disposable injection devices it is intended to discard the entirety of the injection device when the content, i.e. the medicament, has been used up. Disposable injection devices may be prefilled with the injectable medicament.

[0010] Medical devices, such as drug delivery devices or injection devices may have a limited lifetime. Due to regulatory provisions or for reasons of patient safety, medical devices or drug delivery devices may only be used for a rather limited number of times. Also, some medical devices, drug delivery devices or injection devices or parts thereof may be intended only for a one-time use. They may be designed or constructed as disposable devices or device components, which are intended to be discarded after use. Such medical devices or injection devices for single or multiple use may therefore represent or impose a comparatively high environmental burden.

[0011] Such medical devices, drug delivery devices or injection devices commercially distributed for home medication are typically made from injection moldable plastic material, which comes along with some drawbacks in terms of biocompatibility when the respective device has reached its end of lifetime. However, and nowadays injection moldable plastic materials seem to be without alternative in order to provide a cost efficient and lightweight drug delivery device or injection device, which is also easy and intuitive to handle.

[0012] It is therefore desirable to reduce an environmental burden or impact caused by medical devices, drug delivery devices or injection devices. In particular, it would be desirable to provide medical devices, drug delivery devices or injection devices that exhibit an improved ecological footprint. In a similar aspect it may be desirable to improve medical devices with regards to their biodegradability to help improving their ecological footprint.

[0013] Summary

[0014] In one aspect there is provided a medical device component. The medical device component comprises a molded body. The molded body comprises a first molding material. The first molding material comprises cellulose fibers and a binder. Cellulose fibers and the binder may exhibit an excellent degree of biodegradability. Thus, the molded body of the medical device component may exhibit a large degree of environmental compatibility or sustainability. At the same time, the cellulose fibers in connection with the binder may exhibit an excellent mechanical stability, thus allowing to manufacture the molded body from such lightweight and rather cost-efficient material.

[0015] Cellulose fibers used for the molded body may be manufactured or obtained from a biological source, such as wood or wood pulp. Also, the binder may be made or derived from a natural source. The binder may comprise starch or proteins or the like binding material, which may be per se biodegradable. In this way the molded body may easily decompose or rot after disposal, particularly when exposed to humidity and / or thermal energy.

[0016] In some examples the binder may be water soluble. Hence, and after use of the medical device component, i.e. when the medical device component is discarded, the binder may dissolve or disintegrate when getting in contact with water or the like liquid media. In this way, the molded body may chemically and / or mechanically decompose thus allowing and supporting for a rather fast and complete biological decomposition of the molded body.

[0017] The molded body of the medical device component may conform any conceivable moldable form or structure. In this way, the molded body may comprise or may constitute a three- dimensional structure. The molded body may comprise a bulk effectively filled with cellulose fibers and binder.

[0018] In some examples the molded body is of unitary three-dimensional structure. The cellulose fibers and the binder may be homogeneously distributed inside the bulk of the molded body. Due to a manufacturing by way of molding the molded body may conform any conceivable moldable shape. This way, the molded body and hence the medical device component may be universally and / or selectively adapted and designed for a plurality of purposes and application scenarios. Hence, the molded body is not limited to a single application scenario. Generally, it may represent numerous parts or components of a medical device. Particularly, the medical device component and hence the molded body may replace a plastic component of an existing medical device. Substitution of a plastic component of an existing medical device or of a medical device component thereof as described herein enhances the biodegradability of the respective medical device component and hence of the entire medical device.

[0019] In some examples the molded body forms or constitutes the medical device component. Here, the medical device component may consist of the molded body.

[0020] In some examples the molded body is dimensionally stable. It may be operable to transfer forces or momentum between other components of the medical device. In some examples the molded body and hence the medical device component may form part of a housing or of a handle of a medical device, which does not get in contact with a physiological fluid or with a medicament. In some examples, the molded body may be manually handled or operated by a user of the medical device or medical device component. According to another example the molded body is at least partially covered or coated with a waterproof layer. Typically, an outside surface of the molded body may be at least partially covered or coated with such a waterproof layer. In some examples the entirety of the outside surface of the molded body may be covered or coated with the waterproof layer. Since the molding material and / or the binder contained therein may be susceptible to water and / or since the integrity and / or stability of the molding material or of the body may be harmed when getting in contact with water, providing of a waterproof coating or layer on or with the molded body may improve the molded body's resistivity against humidity and liquid in general.

[0021] With a waterproof coating or layer the medical device component or molded body can be used for a large variety of application scenarios, wherein the medical device component may be exposed to water or the like dissolving liquid.

[0022] The waterproof layer or coating may comprise a plastic material. It may comprise a plastic foil, such as cellophane, cellulose, epoxy, lacquer, nitrocellulose, nylon, plastic, polyester, polylactide, polyolefin, polyvinyl alcohol, polyvinylchloride, silicone, wax, and any combinations thereof. These materials or material mixture provides an excellent barrier property against liquids, such as water, and are rather easy to adhere or to fix to the surface of the molded body.

[0023] According to another example the waterproof layer comprises a shrinkable foil, e.g a heat shrinkable foil. The heat shrinkable foil may be easily applied to an outside surface of the molded body. In an original state, i.e. before applying heat to the heat shrinkable foil, the foil may be wrapped around the molded body or may be applied to at least a portion of the molded body. By subsequently applying heat to the arrangement of the heat shrinkable foil and the molded body, the heat shrinkable foil typically shrinks due to the thermal impact and may thus conform to the shape of the molded body. This way, there can be provided a high degree of adhesion between the heat shrinkable foil and an outside surface of the molded body. By way of the heat shrinkable foil even portions of the molded body, which may be difficult to reach, can be effectively covered and sufficiently coated and protected with the waterproof layer.

[0024] In some examples the heat shrinkable foil comprises a polyethylene foil. It may comprise a low- density polyethylene foil (LDPE). The heat shrinkable foil may be produced by extrusion of LDPE. In further examples, the heat shrinkable foil comprises at least one of polyvinylchloride (PVC), polyolefin, polyethylene, polypropylene or mixtures thereof.

[0025] According to another example, the molded body comprises a first body component and a second body component adjoining the first body component. The first body component is made of the first molding material and the second body component is made of a second molding material. The second molding material comprises a plastic material. In some examples the plastic material of the second molding material is selected from one of: Polyvinylchloride, Polyethylene, Polyether ether ketone (PEEK), Polycarbonate, Polyethylenimine (PEI), Polysulfone, Polypropylene and Polyurethane, Cyclic Olefin Copolymer (COC), Polylactide (PLA) and any combinations thereof. Polylactides for instance comprise an excellent biodegradability. They are typically produced from renewable raw materials.. They may comprise or contain biodegradable thermoplastic polyester.

[0026] Here, the molded body may comprise a two-component or more-component body, which may be manufactured in a variety of different ways. Due to the choice of molding material, the second body component may exhibit a higher degree of stiffness and rigidity compared to the first body component. In this way, the molded body may be mechanically stabilized by the second body component. The second body component, which is made of a plastic material, may exhibit a lower degree of elasticity or mechanical deformability compared to the material of the first body component. By making use of an at least two-component or more-component molded body any potential disadvantages due to a comparatively low mechanical rigidity of the first body component may be compensated due to the combination and / or composite with the second body component.

[0027] Insofar, the molded body may comprise a composite article composed of the first body component and the second body component. In some examples the first body component and the second body component form a solid composite and thus form a mechanically stable and rather rigid compound structure. The mechanical properties of the first body component and the second body component may mutually complement each other. In examples wherein the first body component exhibits a lower degree of mechanical stability or mechanical rigidity compared to the second body component this disadvantage can be easily compensated in the compound structure of the first and second body components of the molded body.

[0028] In detail, the second body component may mechanically stabilize the molded body. The first body component may enhance the biodegradability of the molded body.

[0029] According to a further example the second body component is at least in portions overmolded by the first body component. Here, the molded body may be insert molded with the second body component constituting or forming an inlay or insert. The second body component may be completed by the first body component. Here, the first body component may entirely form or constitute an outside surface and may thus dominate the outer appearance of the molded body and hence of the medical device component.

[0030] With the second body component insert molded inside the first body component the second body component may be provided as a rigid pre-fabricated component, which is positioned inside the mold. Thereafter, the first molding material may be filled into the mold thereby entirely or at least partially overmolding the first body component in a subsequent molding process.

[0031] In another example the first body component is molded into a cavity provided or formed by the second body component. Also here, the molded body comprises two components that are mutually fixed to each other and which may form a solid composite and hence a compound structure. But here, the first body component may be at least partially located inside a cavity of the second body component. Also here, the second body component may improve the mechanical rigidity and mechanical stability of the molded body, whereas the first body component and hence the first molding material serves to improve the biodegradability of the molded body and hence of the medical device component.

[0032] According to another example the first molding material makes up at least 50 wt.-% (weight percent), at least 60 wt.-%, at least 75 wt.-%or at least 80 wt.-%of the molded body.

[0033] Accordingly, the contribution of the second molding material to the molded body may be less than 20 wt.-%, less than 25 wt.-%, less than 30 wt.-%, less than 40 wt.-% or less than 50 wt.-% of the molded body.

[0034] The specific weight distribution or volume distribution of first and second molding material inside the molded body may depend on the specific application purpose and geometric design or geometric structure of the molded body and the medical device component. In some examples the molded body is an injection molded body. Here, the molded body is produced by injection molding.

[0035] The injection molded body is typically made at least with one injection moldable material, i.e. with the first molding material and optionally also with the second molding material. At least one of the first and the second molding materials is injection moldable. It may be injected into the closed cavity of a mold with high pressure and in a thermally heated state or configuration.

[0036] The injection moldable first and / or second molding material may fill the cavity of the mold and may cure to a certain predefined degree before it is demolded from the mold. In other examples the molded body is compression molded. Here, the mold may be transferred into an open state for filling the cavity of the mold with the first molding material and optionally also with the second molding material. After filling the cavity of the mold with the first and / or second molding materials the mold is closed and the molding material(s) is / are cured under the effect of heat and / or pressure.

[0037] Compression molded bodies can exhibit an excellent surface quality. In some examples the molded body of the medical device component is a compression molded body comprising cellulose fibers and a binder. The molded body is compression molded, which means that the raw material, e.g. a pulp comprising cellulose fibers and the binder, is provided in a mold in which the raw material is molded, i.e. press molded under the application of pressure and heat. Here, at least one or both of the pressing tool and the mold is heated so as to deposit thermal energy into the raw material during the molding step and / or pressing step.

[0038] The compression molded body may be compression molded in a single stage or in a multistage procedure. Hence, the molded body may be molded in a first mold and / or by a first pressing tool, e.g. under the application of heat and pressure. Thereafter, an intermediate product obtained from such a first molding process may be demolded or removed from the first mold and may be subject to a second step of thermal energy deposition and / or compression to improve the quality of its surface finish. This second step may be conducted by making use of a further compression molding tool, which may operate at a different temperature and / or different pressure compared to the first compression molding tool. This way, cellulose fiber based raw materials, such as paper or cardboard can be used to produce a molded body of a medical device component as described herein.

[0039] Compression molded bodies, which have been subject to deposition of heat during and / or after the molding or pressing operation may exhibit a kind of a densified surface structure, which is less prone to ingress of humidity. Such compression molded bodies may therefore comprise an intrinsic water- or liquid-repellent surface finish. At the same time and due to the application of pressure and / or heat during the molding or press-molding step, the mechanical stability of such compression molded bodies, which are based on or comprise cellulose fibers, may be enhanced.

[0040] According to a further example the molded body comprises a multicomponent injection molded body. A multicomponent injection molding, such as a 2k injection molding may be of particular use to produce and / or to manufacture the molded body comprising a first body component and a second body component as described above. Here, one of the first and second body components may be injection molded in a first injection molding step. In a subsequent injection molding step the other one of the first and second body components may be molded. Molding of the first and second body components may take place sequentially, simultaneously or in an at least partially overlapping temporal manner.

[0041] A multicomponent injection molding procedure is particularly suitable to overmold the second body component with the first body-component; or vice versa. Also, a multicomponent injection molding is of particular benefit to produce and / or to manufacture an insert molded body.

[0042] The cavity of the second body component may be a kind of a blind-hole cavity. It may comprise a cup-shaped receptacle, which is open towards only one end. This open ended cavity may at the same time provide and enable filling of the cavity with the first molding material, which when suitably cured, forms the first body component.

[0043] According to a further example, the cavity, which is at least partially filled with the first body component is sealed or closed by a closure. This way, ingress of humidity or other impurities into the cavity can be effectively prevented. At the same time, the first body component can be fixed inside the cavity by way of the closure. Here, the closure may fulfill a twofold function. It may fix the first body component inside the cavity and may seal the cavity against environmental influences.

[0044] According to a further example the closure comprises at least one of a rigid lid and a foil. In some examples the closure may comprise both, a rigid lid provided with a foil. By way of a foil, the closure can provide a seal for sealing the cavity. With a rigid lid, the same kind of a sealing may be obtained. In addition, the mechanical stability or rigidity of the molded body can be improved.

[0045] The closure may be provided as a separate part. It may be fixed to the cavity, to a sidewall of the cavity and hence to at least one of the first body component and the second body component. Fastening of the closure to the molded body may be provided by a mechanical connection, such as a positive fit, by a friction fit between a fastening structure of the molded body and a complementary-shaped counter fastening structure of the closure. Alternatively or additionally, the closure may be fixed to the molded body by way of welding or by way of a curable adhesive.

[0046] According to another example the closure is provided with at least one of a printed label and an electronic label. A printed label may be provided with medical device related information. Such a printed label may contain or provide readable information, e.g. in form of a plain text, numbers or symbols and / or in form a readable code, such as a one-dimensional or two-dimensional optical code, e.g. readable by a respective code reader. This way, the medical device component may be provided with information being indicative of particular properties of the medical device, the associated medicament and its intended use.

[0047] In some examples, an electronic label may be also provided on or may be integrated into the closure. The electronic label may comprise an electronically readable information, which is obtainable or readable by a suitable electronic reader. The electronic label may comprise an antenna and may be configured for wireless transmission of electromagnetic signals, e.g. in the RF range. The electronic label may comprise a passive or active RFID tag, NFC tag or the like wireless communication tag.

[0048] The electronic label may be integrated or adhered on one of the rigid lid and the foil of the closure. This way, the electronic label may be prefabricated on or in one of the rigid lid and the foil. It may be attached to the medical device component by fastening one of the rigid lid and the foil to the molded body. This way, a separate step of attaching or fastening of the electronic label to the molded body can be circumvented. Rather, the electronic label could be attached or fastened to the molded body by integrating or adhering the electronic label to the closure, e.g. by adhering or integrating the electronic label to one of the rigid lid and the foil and by attaching, fixing or fastening the closure to the molded body thereafter.

[0049] In some examples the electronic label may be provided with an electronic memory, which is operable to store electronic information with the electronic label. This way a wireless reader operable to wirelessly communicate with the electronic label may read the respective information from the electronic memory. In some examples an external electronic reader may be also operable to write information into the electronic memory of the electronic label. This way, the electronic label could be also provided with information being indicative of a past or repeated use of the medical device.

[0050] According to a further example the first molding material comprises 50 wt.-% - 80 wt.- % of the binder, 5 wt.- % - 20 wt.-% of cellulose fibers and 10 wt.-% - 30 wt.-% of water.

[0051] According to another example the first molding material comprises: 60 wt.-% - 75 wt.- % of the binder, 10 wt.- % - 15 wt.-% of cellulose fibers and 10 wt.-% - 30 wt.-% of water.

[0052] These examples of molding material compositions are particularly suitable to provide an injection moldable molded body. The molding material composition may be suitable as a basis for a molded body made of injection molded paper.

[0053] The first molding material may be provided in a slurry containing water, the binder and the cellulose fibers. The slurry may be injection moldable thus forming a molded body, which may be regarded as a paper-based injection molded body.

[0054] The molded body, e.g. in form of so-called injection molded paper or formed by injection molded paper, may exhibit a comparatively high degree of mechanical stability. It may also comprise or exhibit a high-quality surface finish, which may be obtained by the injection molding process. In particular, the surface of the molded body may precisely conform to the inside surface of the injection mold. The surface finish may be particularly smooth and even and may exhibit a comparatively low degree of roughness thus providing the molded body with a smooth surface finish.

[0055] According to a further example the second molding material comprises at least one of Polyvinylchloride, Polyethylene, Polyether ether ketone (PEEK), Polycarbonate, Polyethylenimine (PEI), Polysulfone, Polypropylene, Polyurethane, Cyclic Olefin Copolymer (COC), Polylactide and any combinations thereof and any mixtures thereof. Also, the second molding material may be injected moldable. Specifically, the second molding material may enhance the structural and mechanical stability or rigidity of the molded body and hence of the medical device component.

[0056] According to another example the molded body forms or constitutes at least one of a handle or finger grip of an injection device, a housing component of the injection device, a cap or protective cap of the injection device, a plunger assembly, a plunger of a syringe or a plunger flange of the syringe.

[0057] Specifically and when the molded body of the medical device component is void of the second body component and thus comprises only a first molding material including cellulose fibers and a binder, the molded body may be restricted to the formation or manufacturing of a medical device component that does not get in contact with medicaments or physiological fluids.

[0058] In other examples and wherein the medical device component comprises first and second body components, wherein the second body component is made of a plastic material, the use of the medical device component is void of any restrictions. Here and in particular when the first body component is entirely encapsulated by the second body component, the molded body as such may even get in contact with sensitive liquid substances, such as medicaments or physiological substances, such as bodily fluids.

[0059] According to another aspect the present disclosure relates to a medical device. The medical device comprises a medical device component as described above. The medical device may even comprise numerous medical device component as described above, wherein the numerous medical device components may be of equal constitution or composition or of different constitution or composition.

[0060] According to another aspect the present disclosure also relates to a drug delivery device for administering a dose of a medicament. The drug delivery device comprises at least one medical device component as described above. The drug delivery device may be implemented as a reusable drug delivery device or as a disposable drug delivery device, wherein the disposable drug delivery device is intended to be discarded after a repeated use or a single use.

[0061] By making use of a medical device component as described above in a drug delivery device the biodegradability as well as the environmental compatibility or sustainability of the drug delivery device can be improved and enhanced.

[0062] In still another aspect the present disclosure relates to an injection device for injecting a dose of a medicament. The injection device comprises at least one medical device component as described above.

[0063] In some examples the injection device comprises a syringe. In some examples the injection device comprises a safety syringe. In other examples the injection device comprises a pen-type injector. In some examples the injection device comprises a so-called auto injector. In some examples the injection device comprises a single dose injection device or fixed dose injection device, which is operable to inject a dose of a predefined size only once or multiple times. In other examples the injection device comprises a variable dose injection device, wherein a user may individually select or set a dose of different size for a subsequent injection.

[0064] Also here, the injection device may be implemented as a reusable device or as a disposable device. With a disposable device, the device as such may be entirely discarded after use. In some examples only portions of the injection device are reusable and other portions are disposable. Here, it may be of particular benefit, when the medical device component as described above is provided in or forms the disposable component.

[0065] According to another example the injection device comprises at least one of a medicament container and a barrel containing an injectable medicament.

[0066] In still another aspect the present disclosure also relates to a method of manufacturing a medical device component as described above. The method comprises the steps of providing a mold, filling the mold at least with the first molding material, applying thermal energy to at least one of the mold at and the molding material inside the mold and demolding the molded body from the mold.

[0067] In some examples the method includes an injection molding of the molded body. In other examples the method of manufacturing includes a compression molding of the molded body. In some examples the method includes a single component injection molding of the molded body. In some examples the method of manufacturing the medical device component includes a two- component or more-component injection molding process, wherein first and second body components of the molded body are injection molded sequentially.

[0068] The method of manufacturing the medical device component is particularly configured and intended to manufacture a medical device component as described herein. Insofar all effects, features and benefits as described above in connection with the medical device component equally apply to the method of manufacturing; and vice versa.

[0069] Generally, the scope of the present disclosure is defined by the content of the claims. The disclosure is not limited to specific embodiments or examples but comprises any combination of elements of different embodiments or examples. Insofar, the present disclosure covers any combination of claims and any technically feasible combination of the features disclosed in connection with different examples or embodiments.

[0070] In the present context the term ‘distal’ or ‘distal end’ relates to an end of the injection device that faces towards an injection site of a person or of an animal. The term ‘proximal’ or ‘proximal end’ relates to an opposite end of the injection device, which is furthest away from an injection site of a person or of an animal.

[0071] The terms “drug” or “medicament” are used synonymously herein and describe a pharmaceutical formulation containing one or more active pharmaceutical ingredients or pharmaceutically acceptable salts or solvates thereof, and optionally a pharmaceutically acceptable carrier. An active pharmaceutical ingredient (“API”), in the broadest terms, is a chemical structure that has a biological effect on humans or animals. In pharmacology, a drug or medicament is used in the treatment, cure, prevention, or diagnosis of disease or used to otherwise enhance physical or mental well-being. A drug or medicament may be used for a limited duration, or on a regular basis for chronic disorders.

[0072] As described below, a drug or medicament can include at least one API, or combinations thereof, in various types of formulations, for the treatment of one or more diseases. Examples of API may include small molecules having a molecular weight of 500 Da or less; polypeptides, peptides and proteins (e.g., hormones, growth factors, antibodies, antibody fragments, and enzymes); carbohydrates and polysaccharides; and nucleic acids, double or single stranded DNA (including naked and cDNA), RNA, antisense nucleic acids such as antisense DNA and RNA, small interfering RNA (siRNA), ribozymes, genes, and oligonucleotides. Nucleic acids may be incorporated into molecular delivery systems such as vectors, plasmids, or liposomes. Mixtures of one or more drugs are also contemplated.

[0073] The drug or medicament may be contained in a primary package or “drug container” adapted for use with a drug delivery device. The drug container may be, e.g., a cartridge, syringe, reservoir, or other solid or flexible vessel configured to provide a suitable chamber for storage (e.g., shorter long-term storage) of one or more drugs. For example, in some instances, the chamber may be designed to store a drug for at least one day (e.g., 1 to at least 30 days). In some instances, the chamber may be designed to store a drug for about 1 month to about 2 years. Storage may occur at room temperature (e.g., about 20°C), or refrigerated temperatures (e.g., from about - 4°C to about 4°C). In some instances, the drug container may be or may include a dualchamber cartridge configured to store two or more components of the pharmaceutical formulation to-be-administered (e.g., an API and a diluent, or two different drugs) separately, one in each chamber. In such instances, the two chambers of the dual-chamber cartridge may be configured to allow mixing between the two or more components prior to and / or during dispensing into the human or animal body. For example, the two chambers may be configured such that they are in fluid communication with each other (e.g., by way of a conduit between the two chambers) and allow mixing of the two components when desired by a user prior to dispensing. Alternatively or in addition, the two chambers may be configured to allow mixing as the components are being dispensed into the human or animal body.

[0074] The drugs or medicaments contained in the drug delivery devices as described herein can be used for the treatment and / or prophylaxis of many different types of medical disorders. Examples of disorders include, e.g., diabetes mellitus or complications associated with diabetes mellitus such as diabetic retinopathy, thromboembolism disorders such as deep vein or pulmonary thromboembolism. Further examples of disorders are acute coronary syndrome (ACS), angina, myocardial infarction, cancer, macular degeneration, inflammation, hay fever, atherosclerosis and / or rheumatoid arthritis. Examples of APIs and drugs are those as described in handbooks such as Rote Liste 2014, for example, without limitation, main groups 12 (antidiabetic drugs) or 86 (oncology drugs), and Merck Index, 15th edition.

[0075] Examples of APIs for the treatment and / or prophylaxis of type 1 or type 2 diabetes mellitus or complications associated with type 1 or type 2 diabetes mellitus include an insulin, e.g., human insulin, or a human insulin analogue or derivative, a glucagon-like peptide (GLP-1), GLP-1 analogues or GLP-1 receptor agonists, or an analogue or derivative thereof, a dipeptidyl peptidase-4 (DPP4) inhibitor, or a pharmaceutically acceptable salt or solvate thereof, or any mixture thereof. As used herein, the terms “analogue” and “derivative” refers to a polypeptide which has a molecular structure which formally can be derived from the structure of a naturally occurring peptide, for example that of human insulin, by deleting and / or exchanging at least one amino acid residue occurring in the naturally occurring peptide and / or by adding at least one amino acid residue. The added and / or exchanged amino acid residue can either be codable amino acid residues or other naturally occurring residues or purely synthetic amino acid residues. Insulin analogues are also referred to as "insulin receptor ligands". In particular, the term ..derivative” refers to a polypeptide which has a molecular structure which formally can be derived from the structure of a naturally occurring peptide, for example that of human insulin, in which one or more organic substituent (e.g. a fatty acid) is bound to one or more of the amino acids. Optionally, one or more amino acids occurring in the naturally occurring peptide may have been deleted and / or replaced by other amino acids, including non-codeable amino acids, or amino acids, including non-codeable, have been added to the naturally occurring peptide.

[0076] Examples of insulin analogues are Gly(A21), Arg(B31), Arg(B32) human insulin (insulin glargine); Lys(B3), Glu(B29) human insulin (insulin glulisine); Lys(B28), Pro(B29) human insulin (insulin lispro); Asp(B28) human insulin (insulin aspart); human insulin, wherein proline in position B28 is replaced by Asp, Lys, Leu, Vai or Ala and wherein in position B29 Lys may be replaced by Pro; Ala(B26) human insulin; Des(B28-B30) human insulin; Des(B27) human insulin and Des(B30) human insulin.

[0077] Examples of insulin derivatives are, for example, B29-N-myristoyl-des(B30) human insulin, Lys(B29) (N- tetradecanoyl)-des(B30) human insulin (insulin detemir, Levemir®); B29-N- palmitoyl-des(B30) human insulin; B29-N-myristoyl human insulin; B29-N-palmitoyl human insulin; B28-N-myristoyl LysB28ProB29 human insulin; B28-N-palmitoyl-LysB28ProB29 human insulin; B30-N-myristoyl-ThrB29LysB30 human insulin; B30-N-palmitoyl- ThrB29LysB30 human insulin; B29-N-(N-palmitoyl-gamma-glutamyl)-des(B30) human insulin, B29-N-omega- carboxypentadecanoyl-gamma-L-glutamyl-des(B30) human insulin (insulin degludec, Tresiba®); B29-N-(N-lithocholyl-gamma-glutamyl)-des(B30) human insulin; B29-N-(w- carboxyheptadecanoyl)-des(B30) human insulin and B29-N-(w-carboxyheptadecanoyl) human insulin.

[0078] Examples of GLP-1 , GLP-1 analogues and GLP-1 receptor agonists are, for example, Lixisenatide (Lyxumia®), Exenatide (Exendin-4, Byetta®, Bydureon®, a 39 amino acid peptide which is produced by the salivary glands of the Gila monster), Liraglutide (Victoza®), Semaglutide, Taspoglutide, Albiglutide (Syncria®), Dulaglutide (Trulicity®), rExendin-4, CJC- 1134-PC, PB-1023, TTP-054, Langlenatide / HM-11260C (Efpeglenatide), HM-15211 , CM-3, GLP-1 Eligen, ORMD-0901, NN-9423, NN-9709, NN-9924, NN-9926, NN-9927, Nodexen, Viador-GLP-1, CVX-096, ZYOG-1, ZYD-1, GSK-2374697, DA-3091, MAR-701 , MAR709, ZP- 2929, ZP-3022, ZP-DI-70, TT-401 (Pegapamodtide), BHM-034. MOD-6030, CAM-2036, DA- 15864, ARI-2651, ARI-2255, Tirzepatide (LY3298176), Bamadutide (SAR425899), Exenatide- XTEN and Glucagon-Xten.

[0079] An example of an oligonucleotide is, for example: mipomersen sodium (Kynamro®), a cholesterol-reducing antisense therapeutic for the treatment of familial hypercholesterolemia or RG012 for the treatment of Alport syndrom. Examples of DPP4 inhibitors are Linagliptin, Vildagliptin, Sitagliptin, Denagliptin, Saxagliptin, Berberine.

[0080] Examples of hormones include hypophysis hormones or hypothalamus hormones or regulatory active peptides and their antagonists, such as Gonadotropine (Follitropin, Lutropin, Choriongonadotropin, Menotropin), Somatropine (Somatropin), Desmopressin, Terlipressin, Gonadorelin, Triptorelin, Leuprorelin, Buserelin, Nafarelin, and Goserelin.

[0081] Examples of polysaccharides include a glucosaminoglycane, a hyaluronic acid, a heparin, a low molecular weight heparin or an ultra-low molecular weight heparin or a derivative thereof, or a sulphated polysaccharide, e.g. a poly-sulphated form of the above-mentioned polysaccharides, and / or a pharmaceutically acceptable salt thereof. An example of a pharmaceutically acceptable salt of a poly-sulphated low molecular weight heparin is enoxaparin sodium. An example of a hyaluronic acid derivative is Hylan G-F 20 (Synvisc®), a sodium hyaluronate.

[0082] The term “antibody”, as used herein, refers to an immunoglobulin molecule or an antigenbinding portion thereof. Examples of antigen-binding portions of immunoglobulin molecules include F(ab) and F(ab')2 fragments, which retain the ability to bind antigen. The antibody can be polyclonal, monoclonal, recombinant, chimeric, de-immunized or humanized, fully human, non-human, (e.g., murine), or single chain antibody. In some embodiments, the antibody has effector function and can fix complement. In some embodiments, the antibody has reduced or no ability to bind an Fc receptor. For example, the antibody can be an isotype or subtype, an antibody fragment or mutant, which does not support binding to an Fc receptor, e.g., it has a mutagenized or deleted Fc receptor binding region. The term antibody also includes an antigen-binding molecule based on tetravalent bispecific tandem immunoglobulins (TBTI) and / or a dual variable region antibody-like binding protein having cross-over binding region orientation (CODV).

[0083] The terms “fragment” or “antibody fragment” refer to a polypeptide derived from an antibody polypeptide molecule (e.g., an antibody heavy and / or light chain polypeptide) that does not comprise a full-length antibody polypeptide, but that still comprises at least a portion of a full- length antibody polypeptide that is capable of binding to an antigen. Antibody fragments can comprise a cleaved portion of a full length antibody polypeptide, although the term is not limited to such cleaved fragments. Antibody fragments that are useful in the present invention include, for example, Fab fragments, F(ab')2 fragments, scFv (single-chain Fv) fragments, linear antibodies, monospecific or multispecific antibody fragments such as bispecific, trispecific, tetraspecific and multispecific antibodies (e.g., diabodies, triabodies, tetrabodies), monovalent or multivalent antibody fragments such as bivalent, trivalent, tetravalent and multivalent antibodies, minibodies, chelating recombinant antibodies, tribodies or bibodies, intrabodies, nanobodies, small modular immunopharmaceuticals (SMIP), binding-domain immunoglobulin fusion proteins, camelized antibodies, and VHH containing antibodies. Additional examples of antigen-binding antibody fragments are known in the art.

[0084] The terms “Complementarity-determining region” or “CDR” refer to short polypeptide sequences within the variable region of both heavy and light chain polypeptides that are primarily responsible for mediating specific antigen recognition. The term “framework region” refers to amino acid sequences within the variable region of both heavy and light chain polypeptides that are not CDR sequences, and are primarily responsible for maintaining correct positioning of the CDR sequences to permit antigen binding. Although the framework regions themselves typically do not directly participate in antigen binding, as is known in the art, certain residues within the framework regions of certain antibodies can directly participate in antigen binding or can affect the ability of one or more amino acids in CDRs to interact with antigen.

[0085] Examples of antibodies are anti PCSK-9 mAb (e.g., Alirocumab), anti IL-6 mAb (e.g., Sarilumab), and anti IL-4 mAb (e.g., Dupilumab).

[0086] Pharmaceutically acceptable salts of any API described herein are also contemplated for use in a drug or medicament in a drug delivery device. Pharmaceutically acceptable salts are for example acid addition salts and basic salts. Those of skill in the art will understand that modifications (additions and / or removals) of various components of the APIs, formulations, apparatuses, methods, systems and embodiments described herein may be made without departing from the full scope and spirit of the present invention, which encompass such modifications and any and all equivalents thereof.

[0087] An example drug delivery device may involve a needle-based injection system as described in Table 1 of section 5.2 of ISO 11608-1 :2014(E). As described in ISO 11608-1 :2014(E), needlebased injection systems may be broadly distinguished into multi-dose container systems and single-dose (with partial or full evacuation) container systems. The container may be a replaceable container or an integrated non-replaceable container.

[0088] As further described in ISO 11608-1 :2014(E), a multi-dose container system may involve a needle-based injection device with a replaceable container. In such a system, each container holds multiple doses, the size of which may be fixed or variable (pre-set by the user). Another multi-dose container system may involve a needle-based injection device with an integrated non-replaceable container. In such a system, each container holds multiple doses, the size of which may be fixed or variable (pre-set by the user).

[0089] As further described in ISO 11608-1 :2014(E), a single-dose container system may involve a needle-based injection device with a replaceable container. In one example for such a system, each container holds a single dose, whereby the entire deliverable volume is expelled (full evacuation). In a further example, each container holds a single dose, whereby a portion of the deliverable volume is expelled (partial evacuation). As also described in ISO 11608-1 :2014(E), a single-dose container system may involve a needle-based injection device with an integrated non-replaceable container. In one example for such a system, each container holds a single dose, whereby the entire deliverable volume is expelled (full evacuation). In a further example, each container holds a single dose, whereby a portion of the deliverable volume is expelled (partial evacuation).

[0090] Brief description of the drawings

[0091] In the following, numerous examples of a medical device, drug delivery device, injection devices and components thereof will be described in greater detail by making reference to the drawings, in which:

[0092] Fig. 1 schematically illustrates an example of an injection device,

[0093] Fig. 2 shows a further example of the injection device of Fig. 1 with a finger flange mounted to the injection device,

[0094] Fig. 3 shows the injection device according to Fig. 2 after completion of an injection procedure,

[0095] Fig. 4 schematically shows a longitudinal cross-section through an injection device comprising a syringe,

[0096] Fig. 5 is a perspective view of a finger flange for mounting to an injection device,

[0097] Fig. 6 is another perspective view of the finger flange according to Fig. 5,

[0098] Fig. 7 is a flowchart of a method of manufacturing a medical device component as described herein.

[0099] Fig. 8 schematically shows a plunger assembly of a syringe,

[0100] Fig. 9 shows the plunger assembly of Fig. 8 decomposed into a plunger flange and a plunger,

[0101] Fig. 10 provides two perspective illustrations of another example of a syringe plunger,

[0102] Fig. 11 shows a cross-section through a mold for manufacturing the syringe plunger according to Fig. 10,

[0103] Fig. 12 shows two perspective illustrations of another example of a syringe plunger,

[0104] Fig. 13 is a schematic perspective illustration of a further example of plunger assembly of a syringe,

[0105] Fig. 14 is a cross-section through a molded body providing a syringe plunger comprising first and a second body components of first and second molding materials,

[0106] Fig. 15 is a cross-section through the molded body according to Fig. 14 with a closure,

[0107] Fig. 16 is a perspective illustration of the molded body provided with at least one of a printed label and an electronic label,

[0108] Fig. 17 schematically shows an example of an injection device comprising one or several medical device components featuring the molded body as described herein,

[0109] Fig. 18 is a perspective illustration of a protective cap of the injection device according to Fig. 17.

[0110] Fig. 19 shows another example of a medical device component implemented as a butterfly needle,

[0111] Fig. 20 shows an assembly configuration of the butterfly needle according to Fig. 19,

[0112] Fig. 21 shows a further example of a medical device component to be used with an auto injector,

[0113] Fig. 22 shows the medical device component before assembly or engagement with an auto injector,

[0114] Fig. 23 shows the medical device component connected to a needle sleeve of an autoinjector in cross-section,

[0115] Fig. 24 shows another example of a medical device component comprising a molded body, Fig. 25 shows a further configuration of the medical device component according to Fig. 24,

[0116] Fig. 26 is a perspective illustration of the medical device component according to Figs. 24 and 25,

[0117] Fig. 27 shows another example of a medical device component to be used with a prefilled syringe and

[0118] Fig. 28 shows a further configuration of the medical device component according to Fig. 27.

[0119] Detailed Description

[0120] In Figs. 1-4 there is shown a medical device implemented as drug delivery device 40. In the present example the drug delivery device 40 is implemented as an injection device 1 , particularly as a syringe 30. The syringe 30 comprises a barrel 31 filled with a liquid medicament. The barrel 31 extends along or defines a longitudinal direction with a distal direction 2 towards an outlet 32 and with a proximal direction 3 extending in the opposite direction. The distally located outlet 32 is provided with an injection needle 33, which may be detachably connected to the distal end of the barrel 31 or which may be integrated into the distal end 32. Towards the proximal end and hence towards the proximal direction 3, the barrel 31 is provided with a radially outwardly extending barrel flange 35. The barrel flange 35 may form or constitute a kind of a finger grip, e.g. for allowing a user to apply a proximally directed force effect onto the barrel 31.

[0121] Inside the longitudinal barrel 31 there is movably disposed a plunger assembly 39, which comprises a plunger flange 38 and an elongated plunger 36, i.e. a plunger rod, which terminates in proximal direction 3 with the radially widened plunger flange 38.

[0122] A user intending to expel the medicament from the barrel 31 via the injection needle 33 may hold the distally facing side of the barrel flange 35 with the index and middle fingers whilst applying a distally directed pressure onto the plunger flange 38 with his thumb, thereby urging them plunger 36 and hence the entire plunger assembly 39 towards the distal direction 2.

[0123] The distal end of the plunger 36 is provided with a seal 37, which is operable to seal the interior of the sidewall of the barrel 31 as shown in greater detail in Figs. 7 and 8.

[0124] In some examples the barrel 31 may be made of a chemically or pharmaceutically inert material, such as a plastic material or vitreous material, e.g. made of or comprising at least one of a cyclic olefin copolymer (COC) or glass. As it is particularly illustrated in Fig. 1 the syringe 30 may be provided with a separate finger grip 80, which can be detachably fixed to the barrel flange 35 at the proximal end of the barrel 31. The separate finger grip 80 provides an enlargement of the barrel flange 35 and serves to facilitate the general handling of the syringe 30.

[0125] The finger grip 80 as illustrated in Figs. 5 and 6 comprises a unitary body 81. The body 81 comprises a circumferential frame 82, which may be of rectangular or tubular shape and which may define or comprise an aperture 83 for receiving the barrel 31 or at least a portion thereof there through. The finger grip 80 further comprises a first flange portion 84 protruding radially outwardly from the frame 82 along a first direction. The finger grip 80 further comprises a second flange portion 85 protruding along a second direction opposite to the first direction.

[0126] Compared to the first flange portion 84 the second flange portion 85 protrudes from an opposite side of the frame 82. The first and the second flange portions 84, 85 may be integrally formed with the frame 82. The entirety of the frame 82 and the flange portions 84, 85, i.e. the entirety of the body 81 of the finger grip 80 may be implemented as a molded body 51 representing a medical device component 50 as described herein.

[0127] As it is particularly apparent from the perspective illustration of Fig. 6 the aperture 83 formed in the frame 82 comprises a sidewall 86 with stepped portions 87, 88 adjacent the radially outwardly extending end portions 84, 85. The stepped portions 87, 88 provide a radial narrowing of the aperture 83 and serve to receive the barrel flanges 35 of the barrel 31 of the injection device 30. The inner dimensions and geometry of the aperture 83 and / or of the stepped portions 87, 88 may be in close conformity to the barrel flanges 35 in order to provide a mutual fixing and fastening of the finger grip 80 and the syringe 30.

[0128] The finger grip 80 is one example of a medical device component 50 comprising a molded body 51 made of a first molding material 52. The first molding material 52 comprises cellulose fibers and a binder. In other words, the first molding material 52 may be implemented as a paperbased material. In some examples, the first molding material is a kind of an injection molded paper material, hence a paper-based material which is suitable for injection molding.

[0129] The finger grip 80 may be biodegradable. It may be detachably connectable to the syringe 30. After use, the finger grip 80 may be detached from the syringe 30 and may be discarded separately from the residual components of the syringe 30. The finger grip 80 may deposited as organic waste. In some examples the finger grip 80 consists of the first molding material 52. In other examples, the finger grip 80 comprises a first molding material 52 and a second molding material 54, which will be described in greater detail in Figs. 13 and 14.

[0130] The syringe 30 is further equipped with a needle cap 34, which an initial configuration of the syringe 30 covers the injection needle 33. Before injecting the medicament the needle cap 34 has to be removed and may have to be discarded. Generally, also the needle cap 34 may be implemented as a medical device component 50’ comprising a molded body 51 containing or including the first molding material 52 as described above, which contains or includes cellulose fibers and a binder. Thus, the needle cap 34 may be a biocompatible and may contribute to a reduction of the biological footprint of the syringe 30.

[0131] In the example of Figs. 8 and 9, the plunger assembly 39 of the syringe 30 comprises two separate components, namely an elongated plunger 36 forming an elongated rod and a radially widened disc-shaped plunger flange 38, which is to be fastened to a proximal end of the plunger 36. The distal end of the plunger 36 is provided with a seal 37 to engage with an inside of the sidewall of the barrel 31.

[0132] In one example of Figs. 8 and 9, the plunger flange 38 is implemented as the medical device component 50 as described herein, which comprises a molded body 51 comprising a first molding material 52, wherein the first molding material comprises cellulose fibers and a binder. In some examples the plunger 36 or plunger rod comprises a plastic material, e.g. selected from one of the following plastic materials: of Polyvinylchloride, Polyethylene, Polyether ether ketone (PEEK), Polycarbonate, Polyethylenimine (PEI), Polysulfone, Polypropylene and Polyurethane, Cyclic Olefin Copolymer (COC) and any combinations thereof.

[0133] As e.g. illustrated in Fig. 9, the proximal end of the plunger 36 and a receptacle 43 provided at the distal end of the plunger flange 38 may be provided with complementary shaped or corresponding fastening features 41, 42, by way of which the plunger 36 may be detachably fixable to the plunger flange 38; and vice versa. One of the fastening features 41 , 42 may comprise a radial protrusion and the other one of the fastening features 41 , 42 may comprise a complementary shaped radial recess to provide a snap fit fastening of the proximal end of the plunger 36 to the plunger flange 38. It is also conceivable, that the proximal end of the plunger 36 is frictional ly engaged with the receptacle of the plunger flange 38. Here, an outside surface of the sidewall of the plunger 36 may form a friction fit with an inside surface of the receptacle 43. Such a detachable fastening of plunger flange 38 and plunger 36 may be of particular benefit when the plunger flange 38 and the plunger 36 are made of different materials or material combinations. The detachable configuration allows for a separate and individual waste management of these individual components after use of the respective drug delivery device 40 or injection device 1.

[0134] In other examples, also the plunger 36 may be implemented as a molded body 51 comprising the first molding material 52 including cellulose fibers and a binder. Generally, the binder may be selected from starch or proteins or the like binding material, which is per se biodegradable. Optionally, the plunger flange 38 may be implemented as a plastic component.

[0135] In still other examples, both, the plunger flange 38 and the plunger 36 may be implemented in form of a molded body 51 comprising a first molding material 52 including cellulose fibers and a binder. In some examples, both the plunger flange 38 and plunger 36 may comprise or may consist of the first molding material 52. The plunger flange 38 and plunger 36 may each comprise a molded body 51 , wherein the molded bodies 51 of the plunger flange 38 and the plunger 36 comprise an identical material composition. In other examples, the molded body 51 of the plunger flange 38 and the plunger 36 comprise different material compositions. Here, the composition or percentage of cellulose fibers and binder in the first molding material 51 may differ.

[0136] In Figs. 10 and 12 there are shown two examples of a plunger assembly 39 each of which comprising a molded body 51 representing a molded medical device component 50. Also here, the molded body 51 comprises at least a first molding material 52, which comprises cellulose fibers and a binder. The plunger assemblies 39 as shown in Figs. 10 and 12 are of unitary shape. They comprise a molded body 51, wherein the plunger 36 is integrally formed with the plunger flange 38. Hence, the plunger 36 and the plunger flange 38 are integral components of a single pieced plunger assembly 39.

[0137] The plunger 36 of the plunger assembly 39 according to Fig. 10 comprises a somewhat T- shaped cross-section. Whereas the plunger 36 of the plunger assembly 39 of Fig. 12 is of a semicircular or oval shape.

[0138] The medical device components 50 and in particular the molded bodies 51 forming or constituting the plunger assemblies 39 as shown in Figs. 10 and 12-15 are particularly manufactured by way of molding, e.g. by way of injection molding or compression molding, thereby making use of a mold 90 as shown by the combination of Figs. 7 and 11. In some examples, the plunger 36 or plunger assembly 39 as illustrated herein is made from a single molding material comprising cellulose fibers. It may comprise injection molded paper or may be made from a paper-based pulp. In some examples, the plunger 36 or plunger assembly 39 and in particular their molded bodies 51 comprise a compression molded body, which has been produced by applying pressure and heat. This way, there can be provided a dimensionally stable molded body with a high-quality surface finish.

[0139] In a first step 100 of a method of manufacturing a medical device component 50 as described herein, there is provided a mold 90 comprising a first mold part 91 and a second mold part 93. In the example as shown in Fig. 11 only the first mold part 91 comprises a cavity 92 which is to be filled with the molding material 52 in step 102. Thereafter and in step 104 there is applied thermal energy to at least one of the mold 90 and the molding material 52 inside the mold 90. Thereafter and in step 106 the molded body 51 is demolded from the mold 90 thereby obtaining the molded body 51.

[0140] By varying the geometry of the cavity 92 of the mold 90, there can be provided differently shaped molded articles or molded bodies 51 to be used as a medical device component 50.

[0141] In the example of a medical device component 50 implemented as a plunger assembly 39 as shown in Fig. 13, the molded body 51 is at least partially covered or coated with a waterproof layer 66. In some examples, the waterproof layer may be implemented as a shrinkable foil 68. In some examples the waterproof layer 66 may be provided by coating the outside surface of the molded body 51 with a respective coating material, which may be applied e.g. by spray coating. Also here, the molded body 51 may comprise a compression molded body, which is produced and manufactured by applying heat and / or pressure to a mold.

[0142] The shrinkable foil 68 may be implemented as a heat-shrinkable foil, which is shrinking in response to heat exposure. The foil 68 may cover at least a portion or the entirety of an outside surface of the molded body 51. In some examples the foil 68 comprises at least one of a low- density polyethylene foil (LDPE), polyvinylchloride (PVC), polyolefin, polyethylene, polypropylene. In some examples the foil 68 may comprise a PLA foil, which exhibits excellent biodegradability.

[0143] By way of the waterproof or water repellent layer 66 the molded body 51 can be effectively protected against ingress of water or the like liquids. By way of the waterproof or water repellent layer 66 or cover the water compatibility or water susceptibility of the respective medical device component 50 and hence of its molded body 51 can be enhanced. In this way, the molded body 51 may also get in contact with water or liquids without immediately losing its mechanical integrity and / or rigidity.

[0144] In some examples, the entirety of the T-shaped molded body 51 can be covered with a shrinkable foil 68, which is then shrinked to a reduced dimensioned so as to tightly wrap around an outside surface of the molded body 51. In some examples, the medical device component 50 may comprise a first molded body 51 forming or constituting the plunger 36 and a second molded body 51 constituting or forming the plunger flange 38. Here, the plunger 36 and the plunger flange 38 may be provided as separate pieces that have to be assembled together.

[0145] Here, the thinkable foil 68 may be attached or shrinked separately to the plunger 36 and to the plunger flange 38 before the plunger 36 and the plunger flange 38 are mutually assembled or attached. This way, there may be used separate or differently dimensioned foil sheets, each of which being particularly designed and configured for wrapping the plunger 36 and the plunger flange 38 individually. Hence, after wrapping at least dedicated portions of the plunger 36 and the plunger flange 38 in a shrinkable foil 68 the respective components, i.e. the plunger 36 and the plunger flange 38 may be mutually attached or assembled to form a plunger assembly 39.

[0146] The shrinkable foil 68 may not only improve the water-or liquid-repellent capability of the medical device component or of its molded body 51. A shrinkable foil 68 tightly clasped or wrapped around at least a portion of the molded body 51 may also enhance the bodies mechanical stability or rigidity.

[0147] In the example as shown in Figs. 14 and 15 the medical device component is again represented by a plunger assembly 39. Here, the plunger assembly 39 comprises a first body component 53 made of the first molding material 52 and further comprises a second body component 55 adjoining the first body component 53. The second body component is made from another material. In particular, the second body component 55 may comprise a plastic material.

[0148] In some examples, both, the first body component 53 and the second body component 55 are made from injection moldable materials. The first body component 53 is made of the first molding material 52 and comprises cellulose fibers and a binder. The second body component 55 may comprise a plastic material, e.g. selected from at least one of Polyvinylchloride, Polyethylene, Polyether Ether Ketone (PEEK), Polycarbonate, Polyethylenimine (PEI), Polysulfone, Polypropylene and Polyurethane, Cyclic Olefin Copolymer (COC) or Polylactide (PLA) and any combinations thereof. In some examples, the second body component 55 may be provided as an insert and may be overmolded or insert molded in an injection molding process using a mold 90 as described above. Here, the second body component 55 may be provided as a separate part to be positioned inside the mold cavity 92 before the first molding material 52 is injected or filled into the cavity 92.

[0149] In some examples, both, the first body component 53 and the second body component 55 are injection molded in a sequential manner. Typically, in a first injection molding process the second body component 55 is injection molded in a first mold. Thereafter, the first body component 53 is injection molded in the same or in another mold 90.

[0150] A two- or more component injection molding of the molded body 51 is beneficial in that the second molding material 54 and hence the second body component 55 may exhibit a higher degree of mechanical stability and / or mechanical stiffness compared to the first molding material 52 and the first body component 53. Eventual deficiencies of the first molding material 52 in terms of mechanical stability and / or rigidity may be balanced or compensated by the second body component 55 and the second molding material 54 forming or constituting a composite material with the first molding material 52.

[0151] The use and the fraction of the first molding material 52 in a multicomponent molded body 51 is of particular benefit to improve the degree of sustainability and environmental compatibility of the respective medical device component 50. In effect, and compared to conventional medical device components, e.g. made of plastic, substitution of at least a portion of the medical device component by the first body component 53 made of the first molding material 52 allows to reduce the total amount of plastic material required for manufacturing the respective medical device component 50.

[0152] In some examples, the second body component 55 is at least partially or completely overmolded with the first molding material 52 thus forming the first body component 53 at least partially enclosing or covering an outside surface of the second body component 55. Here, with the second body component 55 forming a mechanically stabilizing insert or insert structure for the molded body 51, it may be the first body component 53, that forms or constitutes an outside surface of the molded body 51 and hence of the respective medical device component 50.

[0153] In other examples such as illustrated in Figs. 14 and 15 the second body component 55, e.g. made of a plastic material, comprises or forms a cavity 56, which may be at least partially filled with the second body component 53 made of cellulose fibers and a binder. Here, any potentiality deficit in terms of a chemical or mechanical instability e.g. arising from a paperbased outside surface of the molded body 51 can be effectively compensated or avoided since the first body component 53 and the first molding material 52 may no longer form part of an outside surface of the molded body 51.

[0154] As becomes apparent from a comparison of Figs. 14 and 15, the plunger assembly 39 comprising an elongated plunger 39 and the radially widened plunger flange 38 each comprise a hollow structure with a cavity 56 which is open towards the proximal end, i.e. near the plunger flange 38 facing away the plunger 36.

[0155] The open-ended structure of the plunger flange 38 may be sealed or closed in proximal direction by a closure 60, e.g. formed by a rigid lid 62 and / or by a foil 64. In some examples, the rigid lid 62 may comprise a structurally stable plastic component, which may be adhesively attached or welded to the sidewall of the proximal end of the second body component 55 thus closing the interior of the cavity 56. The cavity 56 formed inside the second body component 55 may be closed towards the distal end. This way, the cavity 56 can be filled with the first molding material 52 from the proximal direct 10. After filling or injection molding the first molding material 52 into the cavity 56, the respective cavity 56 can be sealed or closed with the closure 60.

[0156] As further shown in Fig. 16, the closure 60 and / or a proximal end of the plunger flange 38 may be provided with at least one of a printed label 70 and an electronic label 72. The printed label 70 may comprise printed and hence readable information being indicative of the medical device component 50 and hence of the respective medical device, a drug delivery device 40 or syringe 30.

[0157] The printed label 70 may be visually printed on the closure 60, e.g. either directly on the rigid lid 62 or on the foil 64. In some examples, the printed foil 64 may be attached to the rigid lid 62 after being printed with readable information.

[0158] In some examples, the electronic label 72 may be attached to one of the rigid lid 62 and the foil 64. It may be also integrated into one of the rigid lid 62 and the foil 64. The electronic label 72 may be implemented as a passive wireless communication tag, such as a RFID communication tag or NFC communication tag. The electronic label 72 may comprise a processor and an antenna as well as a memory. When in a reading distance to a corresponding reading device information stored in the memory of the electronic label 72 can be read out and transmitted to the reading device for further data- and / or signal processing. In other examples, the electronic label 72 may be attached to or integrated into the plunger 36 as indicated in Fig. 4.

[0159] Generally, almost any component of the syringe 30 and hence of the drug delivery device 40 can be implemented as a molded body 51 thus forming or constituting a medical device component 50 as described herein.

[0160] The implementation of the finger grip 80, the plunger assembly 39 as a single-pieced or multicomponent medical device component 50 comprising a molded body 51 including cellulose fibers and a binder and / or manufactured from injection moldable paper is only illustrative of the general principle of manufacturing a medical device component 50 on the basis of a molding material comprising cellulose fibers. Generally, any component of the injection devices 1 or syringe 30 as illustrated and described herein may be manufactured from such first molding material 52 and / or in combination with an optional second molding material 54.

[0161] In Fig. 17 another example of an injection device 1 is schematically illustrated, which injection device 1 is implemented as a handheld injection device 1. The injection device 1 may comprise or may be implemented as a pen-type injector. It may be implemented as a disposable injection device or as a reusable injection device. With some examples the injection device 1 is implemented as an autoinjector. The injection device 1 is of elongated shape. It may extend along a longitudinal direction. Towards the longitudinal distal direction 2 the drug delivery device 1 comprises a dispensing end for dispensing or injecting a medicament 24. Towards the proximal direction 3 the injection device 1 comprises at least one of a dose member 8 and a trigger 9, by way of which a dose of equal size or individual doses or different size can be set and dispensed, respectively.

[0162] The injection device 1 comprises a housing 10. The housing 10 may comprise numerous housing components, such as a body 6 and a container part 7, e.g. implemented as a cartridge holder 7. The body 6 may be sized and configured to accommodate a drive mechanism 20. The container part 7 is sized and configured to accommodate a medicament container 21, e.g. implemented as a cartridge containing the liquid medicament 24. The medicament container 21 comprises a tubular-shaped barrel 22 sealed towards the distal end by a seal 23. The seal 23 may comprise a pierceable septum fixed to an outlet 25 of the medicament container 21. Towards a proximal end the interior of the barrel 22 is sealed by a piston 18 or stopper, which is slidably disposed inside the barrel 22. By advancing the piston 18 towards the distal direction 2 a dose of the medicament 24 can be expelled from the medicament container 21. In use the medicament container 21 is arranged inside the container part 7. The drive mechanism 20 of the injection device 1 comprises a piston rod 19, which is displaceable in distal direction 2 for advancing the piston 18 towards the outlet 25 of the medicament container 21. Details of the drive mechanism are not further illustrated and described here. In some examples, the drive mechanism 20 may be implemented as an allmechanical drive mechanism, where a user provides the entirety of a dispensing force required to move the piston rod 19 and hence the piston 18 in distal direction 2. In other examples, the drive mechanism comprises a mechanical energy storage configured to provide at least a portion of the dispensing force. Examples of drive mechanisms can be found e.g. in W02004 / 078241 A1 , WO 2014 / 033197 A1 or WO 2014 / 033195 A1 the entirety of which are herein incorporated by reference.

[0163] In some examples, the injection device 1 and hence the drive mechanism 20 may comprise a dial extension, which projects and moves in proximal direction 3 from a proximal end of the body 6 during setting a dose and which returns into its initial distal end position during a dose injection procedure. For this, a user may use a thumb of his hand to exert a distally directed pressure onto the trigger 9 thereby urging the dial extension in distal direction 2 during and / or for a dose injection procedure.

[0164] For setting or dialing of a dose a user may twist or rotate the dose dial 8, e.g. in a dose incrementing direction 4, hence in a clockwise sense as seen from the proximal end. For correcting a dose previously set the user may also rotate the dose dial 8 in an opposite dose decrementing direction 5. The size of the dose is typically illustrated in a window 26 provided in or on the body 6 of the injection device 1. Prior to inject a dose of the medicament 24 the distal end of the container part 7 or cartridge holder has to be connected with a needle assembly 12. For this, the distal end of the cartridge holder 7 comprises a connector 11 , e.g. in form of a threaded interface to engage with a complementary shaped threaded counter interface of the needle assembly 12.

[0165] The needle assembly 12 is detachably or releasably fixable to the container part 7. It comprises a double-tipped injection needle 13. A proximal end of the injection needle (not shown) is configured to enter into a through opening at the distal end face of the connector 11 or container part 7 so as to pierce or to penetrate the seal 23 of the medicament container 21. The distal end of the injection needle 13 is typically covered by a detachable inner needle cap 14. The entirety of the needle assembly 12 may be covered by a detachable outer needle cap 15. The container part 7 and hence a portion of the housing 10 is to be received in a protective cap 16, which is detachably connectable to the cartridge holder 7 or body 6.

[0166] In the example of Fig. 18 the protective cap 16 may be implemented as a medical device component 50 as described herein. The protective cap 16 may comprise a molded body 51 comprising a first molding material 52 featuring cellulose fibers and a binder. In other words, the protective cap 16 may be made from injection molded paper. Also, any one of the further caps 14, 15 may be implemented as a medical device component 50 as described herein comprising a molded body 51 containing cellulose fibers.

[0167] During use and over the lifetime of the injection device 1 neither the protective cap 16 nor any one of the further caps 14, 15 will be subject to substantial mechanical forces. The various caps 14, 15, 16 serve to protect the distal end of the injection device 1 against environmental influences. The caps 14, 15, 16 may be snap fitted to or frictionally engaged with at least one of the container part 7, the body 6 and the needle assembly 12 of the injection device 1.

[0168] As it is described with the examples of Figs. 5 and 6 and 8-16 also any one of the caps 14, 15, 16 may be provided with a waterproof or water repellent foil 64 or layer 66. They may be implemented as a single pieced component, e.g. comprising only the first molding material 52. In some examples at least one of the caps 14, 15 and 16 may be implemented as a two- component or multicomponent injection molded part comprising a first body component 53 made of the first molding material 52 and a second body component 55 made of the second molding material 54 as described above.

[0169] In some examples, an outside surface of the sidewall of at least any one of the caps 14, 15 and 16 may be provided, e.g. printed with a visible label. Moreover, any of the caps 14, 15 and 16 could be provided with an electronic label 72, e.g. inside a cavity of the respective cap 14, 15, 16.

[0170] Insofar, all features and effects as described above in connection with the finger grip 80 or plunger assembly 39 equally apply to the protective cap 16 and vice versa.

[0171] In Figs. 19 and 20 there is shown another example of a medical device component 50 as described herein. The medical device component 50 comprises a gripping part 110 to be used with an injection device 1 , which is implemented as a so-called butterfly needle 100. The gripping part 110 comprises a molded body 51 comprising a first molding material as described above. The butterfly needle 100 comprises two individual parts or components that require mutual assembly, namely the gripping part 110 and a needle assembly. The needly assembly comprises at least a needle hub 101 and a needle 33. The needle hub 101 comprises a sleeveshaped structure with a tubular-shaped sidewall 103. The needle 33 protrudes longitudinally from a distal end of the needle hub 101.

[0172] The needle 33, e.g. implemented as an injection needle, is enclosed by a longitudinally extending, e.g. tubular-shaped, sheath 102, which has to be removed from the needle hub 101 and / or from the needle 33 before puncturing a vein or skin of a patient or animal.

[0173] The needle hub 101 may be made of a plastic material. The needle hub 101, e.g., the tubularshaped sidewall 103, is configured to engage with the gripping part 110. For this, the gripping part 110 comprises or constitutes a needle holder 111 and comprises a sleeve 112 with an inside surface or inside cross section that matches with an outside surface or outside cross section of the sidewall 103 of the needle hub 101.

[0174] Hence, the needle hub 101 can be inserted into the hollow sleeve 112 such that the needle 33 protrudes distally from the sleeve 112. The sleeve 112 comprises a longitudinal elongation that may correspond to a respective longitudinal extend or elongation of the needle hub 101. At a longitudinal end the tubular shaped needle hub 101 may comprise at least one radially protruding flange portion 104 that is configured to abut with an end face of the sleeve 112, as e.g. illustrated in a mutual assembly configuration of Fig. 20. The sidewall 103 of the needle hub 101 and the sleeve 112 of the gripping part 110 may form a friction fit when the needle hub 101 is inserted into the sleeve 112 as shown in Fig. 20.

[0175] The gripping part 110 is further provided with a first wing 113 and a second wing 114. The wings 113, 114 each comprise a kind of a flap portion, which is grippable by a user or physician intending to puncture a vein or skin of a patient by way of the needle. The gripping part 110 forms or constitutes a needle holder 111 by way of which the needle hub 101 can be gripped, e.g., by folding the wings 113, 114 towards each other, e.g., by a thumb and by an index finger of a person intending to use the butterfly needle 100.

[0176] In the present example the gripping part 110, which may not get in contact with the needle 33, can be manufactured as a molded body 51 as described above. It may comprise a first molding material featuring cellulose fibers and a binder. This way, a biocompatibility of the butterfly needle 100 can be improved. In Figs. 21-23 there is shown another example of a medical device component 50 as described herein. Here, the medical device component 50 comprises a needle cap remover 130 particularly designed and intended to remove a needle cap 122 or needle sleeve from an injection device 1. Here, the injection device 1 comprises a so-called auto injector 120. The autoinjector 120 is configured to automatically puncture a skin portion of a person and to inject a medicament into the punctured skin portion in response to a user urging a distal dispensing end of the autoinjector 120 against the respective skin portion.

[0177] However, and before conducting such an automated or assisted injection procedure, the user has to remove the needle cap 122, which protects and / or encloses the injection needle of the injection device 1. As becomes apparent from the cross-section of Fig. 23 the needle cap 122 comprises an elongated sleeve 124, which terminates in distal direction by a radially outwardly protruding flange portion 123. The needle cap remover 130 comprises a gripping flange 133, which is larger in radial direction compared to the flange 123. The needle cap remover 130 comprises a slit 131, which is formed or enclosed by a radially inwardly extending ledge 132. The ledge 132 may be of L-shaped geometry in cross section and may comprise a circumferential extent, e.g., forming ll-like shape, interrupted by the slit 131.

[0178] Hence, the surrounding or circumferential ledge 132 may be interrupted in the region of the slit 131. The circumferential extent of the slit 131 may correspond to a diameter of the flange portion 123. In this way, it is possible to arrange or to attach the needle cap remover 132 to the needle cap 123 by way of a radially inwardly directed fastening motion as indicated in Fig. 22. Here, the needle cap remover 130 passes across the flange portion 123 with its slit 131 until it reaches a final assembly configuration, in which the ledge 132 reaches over and engages the flange portion 123. A user may then apply a distally directed force effect onto the needle cap remover 130, thereby transferring and exerting a respective force effect onto the needle cap 122. Consequently, the needle cap 122 can be removed from the auto injector 120.

[0179] The needle cap remover 130 is another example of a medical device component 50 as described herein. The needle cap remover 130 comprises a molded body 51 comprising at least a first molding material including cellulose fibers and a binder. The needle cap remover 130 is particularly made from a material that exhibits an excellent or substantial degree of biodegradability thereby improving the biodegradability of an auxiliary device or device component to be used with an autoinjector 120.

[0180] In the further example of Figs. 24-26 there is shown another possible implementation of a medical device component 50 featuring a molded body 51 as described herein. Here, the molded body 51 and hence the medical device component 50 is part of a cartridge holder 140 of an injection device 1 , e.g. a cartridge holder 140 of an injection pen. Here, the cartridge holder 140 comprises a base part 141 and a cover 150. The base part 141 may be made from a plastic material and the cover 150 is made from a biocompatible material. Hence, the cover 150 may comprise the molded body 50 as described herein whereas the base part 141 may be made from conventional plastic material.

[0181] The base part 141 of the cartridge holder 140 comprises a distal portion 142 which is provided with a connector 11 for a needle assembly 12. The base part 141 further comprises a middle portion 143 connecting the distal portion 142 with the proximal portion 144. At the proximal portion 144 there is typically provided a fastener 145 for connecting the cartridge holder 140 to a body 6 of an injection device 1 , e.g., as illustrated in Fig. 17. The middle portion 143 may comprise an elongated beam or longitudinal profile providing a kind of a connecting structure between the distal portion 142 and the proximal portion 144. Apart from that, the middle portion 143 may be void of an enclosing sidewall. It may be open and almost void of any material as seen in radial direction.

[0182] In order to provide a cover for a medicament container 21 to be accommodated inside the cartridge holder 140 there is provided the cover 150, which is sized to receive at least a part of the distal portion 142, the middle portion 143 and at least a part of the proximal portion 144. The proximal portion 144 may comprise a radially outwardly extending flange portion 147 delimiting a proximal an insert portion 148, which is configured to be inserted into the body 6 of the injection device 1. On the insert portion 148 there is typically provided a fastener 145 configured to engage with a complementary shaped counter fastener provided on or in a distal end of a sidewall of the body 6 of the injection device 1.

[0183] The flange portion 147 further defines or forms a longitudinal or axial abutment for the cover 150. Optionally, there may be provided a radially outwardly extending counter fastener 146 on an outside surface of the proximal portion 144 that engages with a complementary shaped fastener 152 as provided on an inside surface of the cover 150. In some examples the cover 150 may form a friction fit with at least one of the distal portion 142 and the proximal portion 144. It may be then void of a form fitting- or snap-fastener.

[0184] The cover 150 comprises a tubular shaped sleeve 151. The fastener 152 may comprise a circumferential groove provided on an inside surface of the sleeve 151 shaped to receive or to engage with the counter fastener 146 comprising a radially outwardly projecting protrusion or ledge. A distal end of the sleeve 151 may be provided with a radially outwardly extending flange 153 thus allowing and supporting an easy gripping of the cover 150, e.g., for temporarily disassembling or shifting the cover 150 relative to the base part 141. In some examples, the cover 150 may be opaque and may be insofar non-transparent. The flange portion 153 allows and supports an easy and straightforward gripping of the cover 150 to at least temporally remove or to slide the cover 150 relative to the base part 141 in longitudinal direction to reveal at least a portion of the medicament container 21 , thus allowing for a visual inspection of the medicament container 21.

[0185] In Figs. 27 and 28 there are shown two further examples of a device component 50, 50’ according to the present disclosure. The present example pertains to an injection device 1 implemented as a pre-filled syringe 160. The syringe 160 comprises a barrel 162 and a needle 163 as well as a plunger 164 for expelling the medicament through the needle 163 and into biological tissue. Upon delivery to patients or consumers the prefilled syringes 160 is wrapped or packed in a packaging 170. The packaging 170 may comprise a receptacle 173 for receiving the syringe 160. It may further comprise a dedicated gripping portion 174 on an outside surface configured for an easy and intuitive gripping and / or holding of the entire pre-filled syringe 160.

[0186] Typically, the distal injection end of the syringe 160 is protected and covered by a needle shield 161. Upon delivery to patients the needle shield 161 is received in the receptacle 173. The packaging 170 may further comprise a label 171 provided with regulatory information and / or information regarding use of the injection device 1 and / or regarding the medicament contained therein.

[0187] In the present example the packaging 170 may be implemented as a medical device component 50 as described herein. It may comprise a molded body 51 comprising a molding material 52 comprising cellulose fibers and a binder.

[0188] The packaging 170 further comprises a needle reservoir 172, which comprises a hollow receptacle, which is filled or provided with a further medical device component 50’ as described herein. The further medical device component 50’ may also comprise a molded body 5T comprising at least a first molding material 52’ including cellulose fibers and a binder.

[0189] The molded body 51 and the molded body 5T may comprise different molding materials 52, 52’.

[0190] Typically, the molding material 52’ to be used inside the needle reservoir 172 may be particularly suitable for receiving the tipped end of a used injection needle 163. It may be particularly suitable to absorb a residual amount of a liquid medicament contained in the hollow needle after completion of an injection procedure. By making use of at least one of the above- mentioned molding materials 52, 52’ for manufacturing or providing the molded body 51 , 51’, the ecological footprint and the environmental burden of the disposable prefilled syringe 160 can be effectively reduced. After use and when discarded the molded bodies 51 , 51’ may biologically decompose.

[0191] Reference Numbers

[0192] 1 injection device

[0193] 2 distal direction

[0194] 3 proximal direction

[0195] 4 dose incrementing direction

[0196] 5 dose decrementing direction

[0197] 6 body

[0198] 7 container part

[0199] 8 dose dial

[0200] 9 trigger

[0201] 10 housing

[0202] 11 connector

[0203] 12 needle assembly

[0204] 13 injection needle

[0205] 14 inner needle cap

[0206] 15 outer needle cap

[0207] 16 protective cap

[0208] 17 label

[0209] 18 piston

[0210] 19 piston rod

[0211] 20 drive mechanism

[0212] 21 medicament container

[0213] 22 barrel

[0214] 23 seal

[0215] 24 medicament

[0216] 25 outlet

[0217] 30 syringe

[0218] 31 barrel

[0219] 32 outlet

[0220] 33 injection needle

[0221] 34 needle cap

[0222] 35 barrel flange

[0223] 36 plunger

[0224] 37 seal

[0225] 38 plunger flange

[0226] 39 plunger assembly 40 drug delivery device

[0227] 41 fastening feature

[0228] 42 fastening feature

[0229] 43 receptacle

[0230] 50 medical device component

[0231] 51 molded body

[0232] 52 molding material

[0233] 53 body component

[0234] 54 molding material

[0235] 55 body component

[0236] 56 cavity

[0237] 60 closure

[0238] 62 lid

[0239] 64 foil

[0240] 66 layer

[0241] 70 printed label

[0242] 72 electronic label

[0243] 80 finger grip

[0244] 81 body

[0245] 82 frame

[0246] 83 aperture

[0247] 84 flange portion

[0248] 85 flange portion

[0249] 86 sidewall

[0250] 87 stepped portion

[0251] 88 stepped portion

[0252] 82 housing component

[0253] 90 mold

[0254] 91 mold part

[0255] 92 cavity

[0256] 93 mold part

[0257] 100 butterfly needle

[0258] 101 needle hub

[0259] 102 sheath

[0260] 103 sidewall

[0261] 104 flange portion

[0262] 110 gripping part 111 needle holder

[0263] 112 sleeve

[0264] 113 wing

[0265] 114 wing

[0266] 120 auto injector

[0267] 122 needle cap

[0268] 123 flange portion

[0269] 124 sleeve portion

[0270] 130 needle cap remover

[0271] 131 slit

[0272] 132 ledge

[0273] 133 gripping flange

[0274] 140 cartridge holder

[0275] 141 base part

[0276] 142 distal portion

[0277] 143 middle portion

[0278] 144 proximal portion

[0279] 145 fastener

[0280] 146 counter fastener

[0281] 147 flange portion

[0282] 148 insert portion

[0283] 150 cover

[0284] 151 sleeve

[0285] 152 fastener

[0286] 153 flange portion

[0287] 160 syringe

[0288] 161 needle shield

[0289] 162 barrel

[0290] 163 needle

[0291] 164 plunger

[0292] 170 packaging

[0293] 171 label

[0294] 172 needle reservoir

[0295] 173 receptacle

[0296] 174 gripping portion

Claims

Claims1. A medical device component (50) comprising: a molded body (51), wherein the molded body (51) comprises a first molding material (52) and wherein the first molding material (52) comprises cellulose fibers and a binder.

2. The medical device component (50) according to claim 1 , wherein the binder is water soluble.

3. The medical device component (50) according to any one of the preceding claims, wherein the cellulose fibers and the binder are homogeneously distributed inside a bulk of the molded body (51).

4. The medical device component (50) according to any one of the preceding claims, wherein the molded body (51) is at least partially covered or coated with a waterproof layer (66).

5. The medical device component (50) according to claim 4, wherein the waterproof layer (66) comprises a heat shrinkable foil (68).

6. The medical device component (50) according to any one of the preceding claims, wherein the molded body (51) comprises a first a body component (53) and a second body component (55) adjoining the first body component (53), wherein the first body component (53) is made of the first molding material (52) and wherein the second body component (55) is made of a second molding material (54), wherein the second molding material (54) comprises a plastic material.

7. The medical device component (50) according to claim 6, wherein the second body component (55) at least in portions is overmolded by the first body component (53), or wherein the molded body (51) is insert molded with the second body component (55) constituting or forming an inlay or insert.

8. The medical device component (50) according to claim 6, wherein the first body component (53) is molded into a cavity (56) provided or formed by the second body component (55).

9. The medical device component (50) according to claim 8, wherein the cavity (56) at least partially filled with the first body component (53) is sealed or closed by a closure (60).

10. The medical device component (50) according to claim 9, wherein the closure (60) comprises at least one of a rigid lid (62) and a foil (64).

11. The medical device component (50) according to claim 9 or 10, wherein the closure (60) is provided with at least one of a printed label (70) and an electronic label (72).

12. The medical device component (50) according to any one of the preceding claims, wherein the first molding material (52) comprises:50 wt.-% - 80 wt.- % of the binder,5 wt.- % - 20 wt.-% of cellulose fibers and10 wt.-% - 30 wt.-% of water.

13. The medical device component (50) according to any one of the preceding claims, wherein the molded body (51) is compression molded14. The medical device component (50) according to claim 13, wherein the compression molded body (51) exhibits identified surface structure and comprises an intrinsic water-a liquidrepellent surface finish.

15. The medical device component (50) according to any one of the preceding claims 6 to 11, wherein the second molding material (54) comprises at least one of Polyvinylchloride, Polyethylene, Polyether ether ketone (PEEK), Polycarbonate, Polyethylenimine (PEI), Polysulfone, Polypropylene and Polyurethane, Cyclic Olefin Copolymer (COC), Polylactide (PLA) and any combinations thereof.

16. The medical device component (50) according to any one of the preceding claims, wherein the molded body (51) forms or constitutes at least one of: a handle or finger grip (80) of an injection device (1), a housing component (6, 7) of the injection device (1), a cap (14, 15, 16, 34) of the injection device (1). a plunger (36) of a syringe (30), a plunger flange (38) of the syringe (30), and a plunger assembly (39) of the syringe (30).

17. A drug delivery device (40) for administering a dose of a medicament, the drug delivery device (40) comprising at least one medical device component (50) according to any one of the preceding claims.

18. An injection device (1) for injecting a dose of a medicament, the injection device (1) comprising at least one medical device component (50) according to any one of the preceding claims 1-16.

19. A method of manufacturing a medical device component (50) according to any one of the preceding claims 1-16, the method comprising the steps of: providing a mold (90), filling the mold (90) at least with the first molding material (52), applying thermal energy to at least one of the mold (90) and the molding material (52) inside the mold (90) and - demolding the molded body (51) from the mold (90).

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