WO2024088625A1 - Dispositif d'administration de médicament comportant un corps et des pièces de corps construites à partir de polymères d'origine biologique - Google Patents

Dispositif d'administration de médicament comportant un corps et des pièces de corps construites à partir de polymères d'origine biologique Download PDF

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Publication number
WO2024088625A1
WO2024088625A1 PCT/EP2023/074235 EP2023074235W WO2024088625A1 WO 2024088625 A1 WO2024088625 A1 WO 2024088625A1 EP 2023074235 W EP2023074235 W EP 2023074235W WO 2024088625 A1 WO2024088625 A1 WO 2024088625A1
Authority
WO
WIPO (PCT)
Prior art keywords
connector
housing part
main housing
housing
medicament delivery
Prior art date
Application number
PCT/EP2023/074235
Other languages
English (en)
Inventor
Nadine Kaufmann
Thomas FONTANELLAZ
Lukas HEINIGER
Bernhard GYGAX
Roger Fischer
Original Assignee
Ypsomed Ag
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Ypsomed Ag filed Critical Ypsomed Ag
Publication of WO2024088625A1 publication Critical patent/WO2024088625A1/fr

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/50—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests having means for preventing re-use, or for indicating if defective, used, tampered with or unsterile
    • A61M5/5086—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests having means for preventing re-use, or for indicating if defective, used, tampered with or unsterile for indicating if defective, used, tampered with or unsterile
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2207/00—Methods of manufacture, assembly or production
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/14—Infusion devices, e.g. infusing by gravity; Blood infusion; Accessories therefor
    • A61M5/142—Pressure infusion, e.g. using pumps
    • A61M5/14244—Pressure infusion, e.g. using pumps adapted to be carried by the patient, e.g. portable on the body
    • A61M5/14248—Pressure infusion, e.g. using pumps adapted to be carried by the patient, e.g. portable on the body of the skin patch type
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178—Syringes
    • A61M5/20—Automatic syringes, e.g. with automatically actuated piston rod, with automatic needle injection, filling automatically

Definitions

  • a Medicament Delivery Device With a Housing and Housing Parts Constructed from Bio- Based Polymers
  • the disclosure relates to a medicament delivery device including a main housing and housing parts constructed from bio-based polymers.
  • Medicament delivery devices are used for the subcutaneous or intravenous delivery of fluid medicaments to a patient.
  • the medicament delivery device may be an infusion device for delivering bolus injections on top of a continuous basal delivery rate.
  • the infusion device may be an infusion pump that may be worn by a patient but may not be adhered to the skin of the patient or, a patch pump that may be directly attached to the patient’s skin.
  • the medicament delivery device may be an injection device such as an injection pen, an autoinjector, an autopen or a wearable bolus injector (WBI).
  • WBI wearable bolus injector
  • the medicament delivery device may be a disposable device that is discarded after use or a reusable device. In the latter case, a new and full medicament reservoir is inserted into the medicament delivery device once the previous reservoir has been emptied.
  • a reusable device may provide that only the empty reservoir or empty reservoir unit is discarded.
  • the combined drug delivery device is discarded after use including the reservoir and a dose setting mechanism and a dose delivery mechanism which are all encased in a housing.
  • electronic components for example a battery, a microprocessor and a transmitter/receiver unit are disposed after use.
  • Disposable devices may provide that they are ready to use without any further handling steps that need to be performed by the patient or health care professional. Disposable devices may, when they are not part of or included in a recycling program, end up in the environment increasing pollution. For disposable insulin pens, where annually hundreds of millions of devices are produced, this may have a significant environmental impact.
  • the medicament delivery devices are enclosed in a housing that mechanically supports, for example, the dose setting mechanism, the dose delivery mechanism and/or an electronic module that may include a control unit.
  • the housing protects the inner parts from contamination from the environment.
  • the medicament delivery devices are constructed from a plurality of parts that are assembled for obtaining a ready-to-use device.
  • the housing may include a main housing and several additional housing parts that are assembled during manufacturing to form a fully assembled device.
  • the main housing and additional housing parts may be constructed from a polymeric material as this can be injection molded thereby having a great degree of freedom in providing complex parts that may integrate multiple functionalities. Additionally, injection molding offers standardized and high precision production of parts in quantities that can be easily scaled up to high (i.e. multi-million) volumes.
  • the polymeric materials may be medical grade polymers which are biocompatible (for example tested after ISO 10993, or a USP Class VI material) and do not lead to adverse skin reactions.
  • the polymeric material and the leachables are required to be non-toxic.
  • the polymeric materials may have a high mechanical strength and a high impact resistance, for example to withstand the impact forces of a drop test.
  • the housing parts and the main housing are configured for easy and cost efficient assembly as they need to be assembled in high volume, automated assembly lines. Furthermore, the medicament delivery device and the parts forming the medicament delivery device need to provide for a safe, robust and reliable delivery of the medicament.
  • a requirement, especially for disposable medicament delivery devices may be to lower the environmental impact.
  • using recycled polymers may be eco-friendly, e.g., lead to closing the recycling loop.
  • Another aspect may be to reduce the carbon footprint of the medicament delivery device by using bio-polymeric materials (e.g., bio-polymers) which are not polymerized from petroleum -based raw materials.
  • the bio-polymers may be based on natural, raw materials such as, for example glucose or other saccharides.
  • eco-friendly resources and processes such as, for example by using fermentation processes to obtain the raw materials.
  • Glucose, municipal waste, agricultural waste may be used to obtain bioethanol, biomethanol or iso-butanol that may be catalytically converted into ethylene or propylene monomers for polymerization into polyethylene or polypropylene.
  • Alternative eco-friendly resources may include crude tall oil from the wood pulping industry, used cooking oil or residues from vegetable oil processing.
  • eco-friendly resources alone, do not always lead to a low carbon footprint. Polymerization of the plastics may require a large amount of fossil fuels. Simpler plastics with low energy requirements for polymerization such as bio-polypropylene or bio-polyethylene may lead to a lower carbon footprint of the final product.
  • Using bio-based polymers for the components of the medicament delivery devices may facilitate reducing environmental impacts; another aspect may be to configure the medicament delivery devices such that the parts can be easily disassembled and fed into the recycling stream after the delivery device has been used, e.g., the device may be configured to be recyclable or “designed for recycling”.
  • bio-based polymers for example bio-polymers requiring a low energy consumption for polymerization or the recycled polymers, may be inferior compared to their petroleum-derived counterparts that may require different shapes and mechanical configurations for assembling (and disassembling) the device including the housing parts.
  • the present disclosure provides medicament delivery devices that lower the environmental impact after use and which are configured to be recyclable. Furthermore, methods which facilitate recycling of medicament delivery devices are also provided.
  • the medicament delivery devices may be injection or an infusion devices.
  • the injection devices may be a variable or fixed dose injection pen, an autoinjector or an autopen.
  • the infusion devices may be an infusion pump or a patch pump.
  • the medicament delivery devices may include a main housing including a first connector and a housing part including a second connector. A connection may be formed between the first connector and the second connector thereby connecting the housing part to the main housing.
  • the main housing may enclose or encase other housing parts and may be the outer housing that a user may grip for holding the device during administering medicament from the device, or for placing the delivery device onto the skin.
  • the main housing may provide mechanical support to the other housing parts and protect the housing parts located inside the main housing from contamination.
  • the main housing may be part of a sterile barrier.
  • the main housing may be a sleeveshaped housing or a tubular housing defining a longitudinal axis and include a wall that defines an interior space.
  • the main housing may be of rectangular shape, sleeve-shaped or disc-shaped.
  • the housing part with the second connector may be configured for attachment to the main housing and may be configured for insertion into the interior space.
  • the outer shape of the housing part may be configured to be received by an interior sidewall of the main housing, or vice-versa.
  • the housing part may be, for example, a closure cap or end cap for the main housing, or a reservoir holder for holding a syringe or a cartridge, or a mechanism holder for holding a dose delivery mechanism, or a dose setting mechanism.
  • the housing part may be a dose dial sleeve for a dose setting mechanism.
  • the housing part may hold an electronic module for the medicament delivery device.
  • connection between the first connector on the main housing and the second connector on the housing part may be configured as a snap-fit connection.
  • the connection may be configured as a ratchet or a form fit connection.
  • the second connector or a part of the second connector on the housing part may be configured to abut against a stopping surface in the main housing, for example against a wall of the main housing, .
  • a distance or play between an inner wall of the main housing and an outer surface of the housing part may define a lever arm for the second connector and the second connector may include a protrusion or ledge at the end of a rim of the housing part or at the end of a flexible arm of the housing part and the protrusion or ledge is configured to abut the stopping surface in the main housing for forming the connection.
  • the connection once established, may axially and/or rotationally secure the housing part to the main housing.
  • connection may be a permanent or a releasable connection, and for example, after medicament has been delivered from the delivery device, the housing parts, a drive mechanism, and/or an electronic module may be releasable from each other, for example to allow for recycling of one or more of the components of the medicament delivery device such as the main housing.
  • the second connector on the housing part may be configured with an outer radius in the area connecting the protrusion (or ledge) to a rim or flexible arm of the housing part and the outer radius may be at least equal to the lever arm.
  • a material with inferior mechanical properties may be selected as being a cost-efficient alternative for a high performance material or, alternatively, a material is selected that may be based on recycled polymers or on bio-based polymers that may be beneficial for reducing the environmental impact, for example the carbon footprint for polymerization, but may have lower mechanical properties as well. Avoiding sharp edges (or increasing an outer radius) may therefore enable the combination of using a bio-based (or a recycled) polymer together with a robust configuration of the connection between the main housing and the housing part.
  • the medicament delivery device may include a main housing with a wall defining an inner volume and a first connector may be provided by or be a part of the wall.
  • a first housing part may be located within or inside the inner volume of the main housing and the first housing part may include the second connector.
  • the second connector may be located at an outer surface or periphery of the first housing part.
  • a connection between the first connector and the second connector connecting the housing part to the main housing may be established. The connection may prevent relative movement between the main housing and the first housing part in an axial direction and/or in a rotational direction.
  • a second housing part may be configured for attachment, or may be attached to the main housing, for example to an outer surface of the main housing.
  • the second housing part may fix or reinforce the first connector thereby securing the connection between the first connector and the second connector.
  • the second housing part may fix the first connector against movement, such as radial movement.
  • the second housing part may, for example, at least partially cover the first connector to thereby fix the first connector against movement.
  • the second housing part may be attached to the main housing before or after assembling the main housing and the first housing part.
  • the main housing and/or the first housing part and/or the second housing part may be at least partially constructed from a bio-based polymer or from a recycled polymer for example using injection molding.
  • the connection between the first and second connectors may be a permanent connection or a releasable connection facilitating disassembly of the medicament delivery device after use for recycling of materials or components aiming to close the recycling loop for the parts or for the materials.
  • the use of a bio-based polymer may lower the carbon footprint of the main housing and/or the first and/or second housing parts and therewith the carbon footprint of the assembled medicament delivery device.
  • the use of a recycled polymer implies that no new and a potentially fossil-based polymer is used for manufacturing of parts of the medicament delivery device and additionally contributes to closing the loop for recycling.
  • the bio-based polymer or recycled polymer may be a medical grade polymer.
  • the use of a bio-based or recycled polymer may result in reduced mechanical properties of the main housing and/or the first housing part and therewith also weaken the connection between the first and second connector. Applying the second housing part to the main housing may therefore fix and strengthen the connection between the first and second connectors to obtain a robust and impact resistant connection while using bio-based polymers.
  • the main housing and/or the first housing part and/or the second housing part may be constructed, for example, injection molded, using a bio-based polymer that is selected from polypropylene (bio-PP), polyethylene (bio-PE), a bio-polyester such as polyethylene terephthalate (bio-PET), polyethylene 2,5 -furandicarboxylate (bio-PEF), polyamide (bio-PA), polyoxymethylene (bio-POM), polycarbonate (bio-PC), poly acrylonitrile-butadiene-styrene copolymer (bio-ABS), thermoplastic elastomer (bio-TPE).
  • bio-PP polypropylene
  • bio-PE polyethylene
  • bio-PET polyethylene terephthalate
  • bio-PEF polyethylene 2,5 -furandicarboxylate
  • bio-PA polyamide
  • bio-POM polyoxymethylene
  • bio-PC polycarbonate
  • bio-ABS poly acrylonitrile-butadiene-s
  • blends may be used including a bio-based polymer, for example with a bio-based polymer content that is above 50% Weight/Weight (W/W) or from blends including a recycled polymer.
  • the content of recycled polymer may be above 50% W/W.
  • the blends may be based on fossil based counterparts of the same bio-based polymer.
  • mixtures of polymers may be used, for example a blend of polycarbonate and ABS and one, or both of the polymers may be bio-based.
  • the blend may be based on a recycled polymer and a bio based polymer, or the blend may be based on a recycled polymer and a fossil based polymer.
  • a recycled polymer may be at least partially made from (mechanical or chemical) recycling plastic waste. Examples are recycled polypropylene (R- PP), recycled polyethylene (R-PE) or recycled cycoloyTM (a blend based on polycarbonate and ABS).
  • the original polymer producing the waste may be fossil-based or bio-based.
  • bio-based polymers may lower the carbon footprint of the housing parts and therewith the carbon footprint of the medicament delivery device.
  • recycled polymers may contribute to closing the recycling loop.
  • the bio-based polymer or the recycled polymer may be a medical grade polymer according to USP Class VI or tested after ISO 10993.
  • the first connector on the main housing may include a stopping surface and the second connector on the first housing part may include a protrusion or alternatively, the first connector on the main housing may include a protrusion and the second connector on the first housing part may include a stopping surface, and the connection may be a snap-fit connection configured to be formed between the protrusion abutting the stopping surface.
  • the stopping surface may be formed by a passage in the wall of the main housing.
  • the first connector and/or the second connector may include ramped surfaces facilitating formation of the snap-fit connection during relative movement between the first and second connector.
  • the snap-fit connection may be configured to be a non-releasable connection or a releasable connection.
  • a releasable connection may be beneficial for waste separation as the main housing and the first housing part may be separated and treated as separate components for recycling or re-use.
  • the main housing may include a guide or guiding means for a guiding the protrusion that may be part of the second connector towards the location of the first connector for establishing the connection.
  • the guide may be, for example, a longitudinal groove in the main housing that may accommodate the protrusion and may facilitate the orientation and axial guidance of the first housing part in the main housing.
  • the first connector on the main housing may include a flexible arm adapted to flex radially.
  • the flexible arm may, at least partially, be covered and/or mechanically supported by the second housing part thereby securing the connection when the second housing part is attached to the main housing.
  • the second housing part may at least partially cover the flexible arm and at least partially cover the wall of the main housing.
  • the second housing part may at least partially bridge a gap that may exist between the flexible arm and the remainder of the main housing.
  • the second housing part may thus for instance secure the flexible arm from flexing radially inward or outward, and may facilitate retaining the connection between the first and second connectors.
  • the flexible arm may include the protrusion and/or the stopping surface.
  • the corresponding stopping surface may be available on the first housing part.
  • the first connector on the main housing may include the flexible arm with the stopping surface configured for engaging a matching protrusion on the second connector of the first housing part.
  • the first connector and/or the second connector may include ramped surfaces that may be adjacent to the protrusion or ledge and adjacent to the stopping surface such that relative axial movement between the main housing and the first housing part first leads to a mutual engagement between the ramped surfaces on the first and second connectors thereby flexing the flexible arm before establishing the connection between the stopping surface and the protrusion as the flexible arm flexes back to form the snap-fit connection.
  • Bio-based polymers with a lower carbon footprint may have lower mechanical properties in terms of stiffness such that the flexible arm may flex easily for establishing the connection, but the connection may not be robust enough for withstanding mechanical forces such as during an impact as the arm may flex again for unintended release of the connection.
  • the flexible arm of a housing constructed from a material having lower mechanical properties may therefore be supported, e.g., mechanically supported, by the second housing part which may prevent flexing of the arm and unintended release of the connection. Removing the second housing part may facilitate intended release of the connection between the first and second housing part.
  • the second housing part may be attached to the main housing after forming the connection between the first and second connectors, for example during assembly of the device.
  • the second housing part may be detached or removed from the main housing for disassembly of the main housing and the first housing part.
  • the stopping surface may be arranged in the main housing and may be formed by a passage in the main housing.
  • the passage may include a first slit oriented perpendicular to a longitudinal axis of the main housing connecting two second slits in the main housing oriented parallel to the longitudinal axis thereby forming an essentially U-shaped passage (or wall opening) leaving a free standing tongue as the flexible arm with a free end that may, for instance, point in the proximal or distal direction.
  • the stopping surface may be located at the free end, or in a final section of the flexible arm.
  • the stopping surface may be formed by a wall in the passage or the stopping surface may be shaped as a hook at the end of the flexible arm.
  • the second housing part may be a label or adhesive film that may be at least partially adhesively attached to the main housing.
  • the adhesive film or label may be attached to an outer surface of the main housing when the first and second connectors engage for forming the connection.
  • the label or adhesive film may completely surround a section of the wall of the main housing, or may only partially surround the main housing.
  • the label or adhesive film may be used for displaying information about the medicament, for example a tradename or expiry date may be printed onto the surface of the label prior to attachment to the main housing.
  • the label may be constructed of paper and/or a polymeric material such as polypropylene. In case a polymeric material is used, the material may include or be formed of a bio-based polymer.
  • the label or film may also be non-adhesively attached to the main housing, for example using a form fit or friction fit engagement between the main housing and the second housing part.
  • the label or adhesive film may be attached to the main housing after insertion of the first housing part, which may be for example a syringe holder and/or a closure cap for the housing.
  • the label may be attached after forming the connection between the first connector and the second connector.
  • the label or adhesive film may include perforations to form a predetermined breaking point or predetermined breaking points aligned for predetermined fracture of the label for releasing the label or adhesive film after medicament delivery or after use of the medicament delivery device.
  • the predetermined breaking point may be located in a section of the label or adhesive film that is not adhesively attached to the outer wall of the main housing.
  • the label or adhesive film may include a tear line separating an adhesive area from an arm -covering area of the label.
  • a pull tab may be part of the label or adhesive film located close to, e.g., proximate or adjacent to, the predetermined breaking point facilitating removal of the label or adhesive film. Detachment of the label may be facilitated by steam, hot water or chemicals that may dissolve the adhesive, for example using alcohol.
  • the label or adhesive film may be mechanically reinforced.
  • the reinforcement may be anisotropic for example by uniaxial orientation or stretching of the label when the label is constructed of a polymeric material such as polypropylene.
  • the label may be reinforced using fibers such as flax, hemp or jute.
  • the orientation direction may be oriented perpendicular to a longitudinal axis of the main housing when the label or adhesive fdm has been attached.
  • the label or adhesive fdm may be mechanically reinforced and/or include the predetermined breaking point or breaking line.
  • the predetermined breaking line formed by the perforations may be parallel, perpendicular or angulated to the orientation direction of the reinforced label or fdm.
  • the second housing part may be constructed of a heat- shrinkable material, for example, the main housing may be inserted into a sleeve of a heat shrinkable material after forming the connection and subsequently the connection is fixed or mechanically supported by heating and shrinking the sleeve such that the first connector and a part of the wall of the main housing are covered by the sleeve.
  • the second housing part may be a clip latched to the outer surface of the main housing.
  • the clip may be constructed from a polymeric material, such as a biobased polymer or a recycled polymer. Additionally or alternatively, the clip may be constructed from a metal. The clip may not only fix or reinforce the first connector in the wall of the main housing but may also have an extension for attaching the medicament delivery device to clothing of a patient or health care provider.
  • connection between the first and second connector of the medicament delivery device may be configured to be released such that the second housing part may be detached and/or removed from the main housing.
  • the second housing part may be attached to the main housing during manufacturing and assembly of the medicament delivery device and may be detached from the main housing when a medicament reservoir present in the medicament delivery device has been emptied or has expired.
  • the medicament delivery device may include a main housing including a wall defining an inner volume and may include a first connector that is part of or attached to the wall.
  • the first housing part may be located within the inner volume and may include a second connector for establishing a connection between the first connector and the second connector connecting the first housing part to the main housing.
  • the second housing part may be attached to an outer surface of the main housing thereby at least partially covering and fixating the first connector before medicament delivery or use of the medicament delivery device.
  • the main housing and/or the first housing part and/or the second housing part may be constructed from a biobased polymer or from a recycled polymer and the second housing part may be configured for removal from the outer surface of the main housing after medicament delivery or after use of the medicament delivery device.
  • the first connector may include a flexible arm including a stopping surface configured for engaging a protrusion on the second connector and the flexible arm may be at least partially covered and mechanically supported by the second housing part for securing the connection.
  • the second housing part may be a label that can be adhesively attached to the main housing or the second housing part may be a clip that can be latched onto the outer surface.
  • the label may be adhesively attached to the main housing after forming the connection between the first connector and the second connector connecting the first housing part to the main housing.
  • the label may include predetermined breaking points facilitating fracture and removal of the label after medicament delivery.
  • An embodiment of the disclosure may further include a method for facilitating recycling of a medicament delivery device including a main housing with a wall defining an inner volume having a first connector in the wall, a first housing part including a second connector and a second housing part.
  • the main housing and/or the first housing part and/or the second housing part may be constructed from a bio-based polymer made from non-petroleum derived raw materials or from a recycled polymer; the method including the following steps: inserting the first housing part into the inner volume of the main housing and establishing a connection between the first connector and the second connector, attaching the second housing part to an outer surface of the main housing thereby at least partially covering and fixating the first connector , using the medicament delivery device, removing the second housing part from the medicament delivery device, followed by releasing the connection between the first connector and the second connector such that the main housing and/or the first housing part and or the second housing part are available for waste treatment or material recycling or component re-use.
  • the second housing part may be a label or adhesive film that is adhesively attached to an outer wall of the main housing thereby at least partially covering an outside surface of the main housing and at least partially covering the first connector.
  • connection in the method disclosed above may be a snap-fit connection between a protrusion (or ledge) on the second connector engaging a stopping surface on the main housing that is part of the first connector, or between a stopping surface on the second connector engaging a protrusion on the main housing.
  • the first connector may include a flexible arm and the flexible arm may be, at least partially, covered and mechanically supported by the label or adhesive film.
  • the flexible arm may be formed as a U-shaped passage formed in the wall of the main housing leaving the free standing tongue as a flexible arm.
  • the first connector may include a flexible arm and the stopping surface may be part of the flexible arm and the flexible arm is at least partially covered and mechanically supported by the label or adhesive fdm.
  • the first connector and the second connector may include each a ramped surface promoting flexing of the arm when the ramped surfaces engage each other thereby facilitating establishing the connection between the protrusion and the stopping surface as the arm flexes or snaps back.
  • the stopping surface may be formed at the end of the flexible arm, for example as a hook that is configured to engage the protrusion.
  • Figure la Main housing of a medicament delivery device according to a first embodiment of the present disclosure
  • Figure lb Longitudinal section of Figure la illustrating the assembly of the main housing and a syringe holder
  • Figure 1c Detail of Figure lb illustrating the connection between the first and second connector
  • Figure Id Main housing of Figure la covered by an adhesive film
  • Figure 2a Main housing of a medicament delivery device according to a second embodiment of the present disclosure
  • Figure 2b Longitudinal section of Figure 2a illustrating the assembly of the main housing and a syringe holder
  • Figure 2c Detail of Figure 2b illustrating the connection between the first and second connector
  • Figure 2d Main housing of Figure 2a covered by an adhesive film
  • Figure 3a Exploded view illustrating an assembly of a main housing, a syringe holder and a clips of a medicament delivery device according to a third embodiment of the present disclosure
  • Figure 3b Longitudinal section illustrating the assembly of the main housing, the a syringe holder, and the clips of Figure 3a,
  • Figure 3c Cross-section perpendicular to the longitudinal axis in a plane through the first and second connectors and clips of Figure 3a,
  • Figure 3d Detail illustrating the connection between the first and second connector and positioning of the clips of Figure 3b
  • Figure 4a Assembly of a main housing and an end cap for the main housing of a medicament delivery device according to a fourth embodiment of the present disclosure
  • Figure 4b Detail for Figure 4a illustrating the connection between the first and second connector.
  • medicament includes any flowable medical formulation suitable for controlled administration through a means such as, for example, a cannula or a hollow needle and includes a liquid, a solution, a gel or a fine suspension containing one or more medical active ingredients.
  • a medicament can be a composition including a single active ingredient or a pre-mixed or co-formulated composition with more than one active ingredient present in a single container.
  • Medication includes drugs such as peptides (e.g., insulin, insulin-containing drugs, GLP-1 containing drugs or derived or analogous preparations), proteins and hormones, active ingredients derived from -or harvested by- biological sources, active ingredients based on hormones or genes, nutritional formulations, enzymes and other substances in both solid (suspended) or liquid form but also polysaccharides, vaccines, DNA, RNA, oligonucleotides, antibodies or parts of antibodies but also appropriate basic, auxiliary and carrier substances.
  • drugs such as peptides (e.g., insulin, insulin-containing drugs, GLP-1 containing drugs or derived or analogous preparations), proteins and hormones, active ingredients derived from -or harvested by- biological sources, active ingredients based on hormones or genes, nutritional formulations, enzymes and other substances in both solid (suspended) or liquid form but also polysaccharides, vaccines, DNA, RNA, oligonucleotides, antibodies or parts of antibodies but also appropriate basic, auxiliary and
  • the distal end or distal direction is defined by the direction of the hollow needle configured to penetrate the skin of the patient.
  • an injection device such as an injection pen or an autoinjector this may be the injection needle and the end of the pen holding the needle or being configured to hold the needle is the distal end.
  • the distal end and the distal direction is towards the needle configured to penetrate the skin of the patient, which may be along the axis of the device or tilted or perpendicular to the axis of the device .
  • the distal direction in an infusion device represents the direction in which the medicament flows towards the insertion needle.
  • the proximal direction or end is opposite to the distal direction or end.
  • Figures la, lb, 1c and Id depict a main housing 3 for a medicament delivery device, for example an auto injector or an autopen or a patch injection device, according to the present disclosure.
  • the main housing 3 may be sleeve-shaped, alternatively, the main housing may be disc, oval, or rectangularshaped.
  • the sleeve-shaped main housing 3 defines a longitudinal axis and includes a proximal end 22 and a distal end 23.
  • the main housing 3 includes a wall 4 defining an inner volume or interior 5 configured to receive other housing parts such as, for example, a first housing part 1.
  • the main housing 3 may include a viewing window 24.
  • the first housing part 1 may be a reservoir holder configured to receive and hold a reservoir, for example a cartridge or a syringe.
  • the cartridge or syringe may be empty, pre-filled with a liquid medicament or filled with a solid medicament such as a lyophilisate.
  • the first housing part 1 or reservoir holder may include a flange or sleeve-shaped extension la configured for connecting the first housing part 1 to the main housing 3.
  • the main housing 3 may include a first connector 6.
  • the first connector 6 may include a flexible arm 11 that is part of the wall 4 of the main housing 3.
  • the wall 4 includes a passage 12 formed by a first slit 13 oriented perpendicular to the longitudinal axis of the main housing 3 connecting two second slits 14 oriented parallel to the longitudinal axis thereby forming a U-shaped opening 15 leaving the flexible arm 11 as a free-standing tongue 17 with a free end that points in the distal direction.
  • the first connector 6 may include a sloped surface 6a facilitating insertion of the first housing part 1 from the proximal end 22 into the main housing 3 and the sloped surface 6a is configured to engage a sloped surface 7a that is part of a second connector 7 (see detailed view in Figure 1c).
  • the second connector 7 of the first housing part 1 may be located on, or may be part of the flange or sleeve shaped extension la (depicted in Figure 1c).
  • the second connector 7 may include a protrusion 9 configured to engage a stopping surface 8 of the first connector 6.
  • the stopping surface 8 may be part of the wall 4 and formed by the passage 12.
  • the stopping surface 8 may be located at an end 16 of the flexible arm 11 and configured to prevent proximal movement of the first housing part 1.
  • another stopping surface 8a may be located adjacent to the passage 12 and may prevent distal movement of the first housing part 1.
  • the protrusion 9 of the second connector 7 may thus be confined in the passage 12 thereby limiting axial movement of the first housing part in the proximal and distal direction.
  • the second connector 7 may include the sloped surface 7a configured to engage the sloped surface 6a of the first connector when the snap-fit connection is established.
  • the sloped surfaces 6a, 7a may engage during relative movement thereby radially flexing the flexible arm 11 until the flexible arm relaxes for establishing a snap-fit connection 10 between the first and second connectors 6, 7.
  • a guide 21, for example a groove may be disposed on the inside surface of the wall 4 of the main housing 3, which may be configured to guide the protrusion 9 of the first housing part 1 through the main housing 3 ( Figure 1c).
  • the guide 21 may be, for example, a groove that accommodates the protrusion 9 and guides the protrusion 9 and therewith the first housing part 1 towards the flexible arm 11 and/or the first sloped surface 6a of the first connector 6 of the main housing 3.
  • a second housing part 2 for example an adhesive film 18 or a label (e.g., foil) may be attached to the outer surface of the wall 4 of the main housing 3 (depicted in Figures 1c and Id).
  • the second housing part 2 may at least partially cover the first connector 6 of the main housing 3, for example at least partially cover the flexible arm 11 of the first connector 6.
  • the second housing part 2 may be attached to the outer surface of the main housing 3 after establishing the snap-fit connection 10 between the first connector 6 of the main housing 3 and the second connector 7 of the second housing part 2.
  • the first housing part 1 may be configured as a reservoir holder, for example a syringe holder, and may be inserted into the proximal end 22 of the main housing 3 followed by flexing of the arm 11 of the main housing 3 due to the engagement of the sloped surfaces 6a, 7a of the first connector 6 and the second connector 7, respectively.
  • the second housing part 2 for example, the adhesive film 18 may be adhesively attached to the surface of the main housing 3 once the snap-fit connection 10 has been established, for instance as illustrated in Figure Id.
  • the second housing part 2 may prevent flexing of the flexible arm 11 of the main housing 3 and may thereby prevent unintended release of the snap-fit connection 10, for example during storage or upon a mechanical impact.
  • the adhesive label or adhesive film 18 may be removed for instance when release of the snap-fit connection 10 is desired, such as after use of the medicament delivery device.
  • Providing a releasable snap-fit connection 10 may facilitate intentional disassembly of the medicament delivery device after use for waste treatment or recycling of separate components of the device.
  • Figures 2a, 2b, 2c and 2d depict a second embodiment of a medicament delivery device including a first housing part 1 , a second housing part 2 and a main housing 3 , according to the present disclosure .
  • the main difference between the first embodiment disclosed herein and the second embodiment is that the orientation of the U-shaped opening 15 is reversed and the tongue 17 projects in the proximal direction (Figure 2a).
  • the stopping surface 8 on the flexible arm 11 of the main housing 3 is located close to the end 16 and adjacent to the sloped surface 6a of the first connector 6 ( Figure 2c).
  • the snap-fit connection 10 between the first connector 6 and the second connector 7 may be configured to prevent movement of the first housing part 1 in the proximal direction as the protrusion 9 of the first housing part 1 may abut the stopping surface 8 of the main housing 3.
  • a second housing part 2 (including film 18) may be attached to the outer surface of the main housing 3 and may at least partially cover the first connector 6 which may thereby limit or prevent the flexing of the flexible arm 11 radially outward thereby facilitating securing the snap-fit connection 10 against unintended release, for instance as shown in Figures 2c and 2d.
  • a third embodiment of the medicament delivery device is depicted in Figures 3a, 3b, 3c and 3d.
  • the main housing 3 includes a depression 3a configured to receive the second housing part 2.
  • the second housing part 2 may be configured as a clip 19 having projections 2a.
  • the projections 2a may be configured to engage an undercut 3b of the main housing, and upon engagement may form a snap-fit connection 25.
  • the outer surface of the clip 19 may be flush with the outer surface of the main housing 3 when snap-fitted onto the main housing 3 in the snap-fit connection 25, for instance as shown in Figures 3c and 3d.
  • the clip 19 may prevent flexing of the arm 11 and therewith unintended release of the snap-fit connection 10 between the main housing 3 and the first housing part 1.
  • the clip 19 may be removed for intentional disassembly of the main housing 3 from the first housing part 1.
  • the first housing part 1 may be configured as an end cap 20 that is mounted to a proximal end 22 of the main housing 3.
  • the main housing 3 may include the first connector 6 configured for engagement with the second connector 7 on the end cap 20.
  • the end cap 20 may include a proximal end surface 20a and a skirt 20b that extends from the proximal end surface 20a in the distal direction and may be configured to fit into the inner volume 5 of the main housing 3.
  • a protrusion or ledge 20c may protrude in the radial outward direction.
  • a sloped surface 20d may be located at the distal end of the end cap 20 which may be configured to engage sloped surface 3a as the end cap 20 is inserted into the proximal end 22 of the main housing 3.
  • the engagement of the sloped surfaces 20d, 3a during assembly may flex the skirt 20b of the end cap 20 radially inward towards the longitudinal axis of the main housing 3 and/or the wall 4 of the main housing 3 may locally flex or elastically deform radially outward.
  • the main housing 3 includes the passage 12, in this example (see for example Figure 3a) a slit in the housing oriented perpendicular to the longitudinal axis, configured to engage the protrusion 20c such that the end cap 20 may snap-fit into the main housing 3.
  • the distance between the outer surface of the skirt 20b and the inner surface of the first connector 6 defines a lever arm 20f for the second connector 7.
  • the protrusion 20c is configured to abut the stopping surface 8 such that the end cap may be axially and/or rotationally fixed to the main housing 3.
  • the second connector 7 on the end cap has an outer radius 20e in the area connecting the protrusion (or ledge) to the skirt 20b and the outer radius 20e is at least equal to the lever arm 20f.
  • the lever arm 20f may be, for example between 0.05 mm and 0.15 mm in combination with a radius 20e of the second connector 7 that ranges between 0.15 mm and 0.25 mm.
  • the outer radius having a value greater than the lever arm may be of interest when selecting a material having a lower impact resistance.
  • the main housing 3 may be made from a polymer blend comprising polycarbonate and acrylonitrile butadiene styrene (PC-ABS) which is sold under the tradename CycoloyTM (for example CycoloyTM HCX1640) and may provide a good combination of stiffness (expressed in the tensile modulus) and impact strength (expressed in Charpy Impact strength). This may allow for constructing thin walled parts for the main housing 3 and/or the first housing part 1 and/or the second housing part 2.
  • the CycoloyTM material may, however not be available as a medical grade material based on biopolymers or the carbon footprint for this complex blend of polymers is above the carbon footprint of simpler commodity polymers like polyethylene or polypropylene.
  • the main housing 3, the first and the second housing parts 1,2 may be made from a polypropylene (PP) which has a lower stiffness and impact strength compared to the CycoloyTM material but may be beneficial as having a lower carbon footprint.
  • PP polypropylene
  • the main housing and the housing parts may have a thickwalled construction to compensate for the lower mechanical properties or the lower impact strength is compensated for by increasing the radius in locations that may be subjected to high impact stresses.
  • the reduced mechanical properties may be compensated by one of the embodiments of the current disclosure, for example by using the second housing part fixing the first connector while still using thin walled housing or housing parts.
  • polypropylene materials examples are presented in the table below and the combination of a bio-based polymer and a polymer that fulfills the requirements of a medical grade polymer (for example by fulfilling the ISO 10993 standard, or fulfilling the USP Class VI requirements) may provide guidance for material selection.
  • a bio-based polymer for example by fulfilling the ISO 10993 standard, or fulfilling the USP Class VI requirements
  • a polymer that fulfills the requirements of a medical grade polymer for example by fulfilling the ISO 10993 standard, or fulfilling the USP Class VI requirements
  • the Purell HP671 T bio-based PP may be used for the main housing 3, and/or the first housing part 1 and/or the second housing part 2.

Landscapes

  • Health & Medical Sciences (AREA)
  • Vascular Medicine (AREA)
  • Engineering & Computer Science (AREA)
  • Anesthesiology (AREA)
  • Biomedical Technology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Hematology (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Infusion, Injection, And Reservoir Apparatuses (AREA)

Abstract

L'invention concerne un dispositif d'administration de médicament comprenant un corps principal incluant une paroi qui délimite un volume interne, et incluant un premier élément de liaison qui fait partie de la paroi. Une première pièce du corps se situant à l'intérieur du volume interne comprend un second élément de liaison, une liaison entre le premier élément de liaison et le second élément de liaison reliant la première pièce du corps au corps principal. Une seconde pièce du corps conçue pour être fixée à une surface externe du corps principal de manière à recouvrir et à fixer au moins partiellement le premier élément de liaison et le corps principal et/ou la première pièce du corps et/ou la seconde pièce du corps, est construite à partir d'un polymère d'origine biologique ou d'un polymère recyclé.
PCT/EP2023/074235 2022-10-28 2023-09-05 Dispositif d'administration de médicament comportant un corps et des pièces de corps construites à partir de polymères d'origine biologique WO2024088625A1 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US202263420388P 2022-10-28 2022-10-28
US63/420,388 2022-10-28

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PCT/EP2023/074235 WO2024088625A1 (fr) 2022-10-28 2023-09-05 Dispositif d'administration de médicament comportant un corps et des pièces de corps construites à partir de polymères d'origine biologique

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Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20130261552A1 (en) * 2010-12-21 2013-10-03 Sanofi-Aventis Deutschland Gmbh Drug delivery device with housing comprising frangible zone
US20130261555A1 (en) * 2010-12-21 2013-10-03 Sanofi-Aventis Deutschland Gmbh Drug Delivery Device with Housing Comprising Frangible Zone
WO2022171343A1 (fr) * 2021-02-15 2022-08-18 Shl Medical Ag Supports de seringue

Patent Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20130261552A1 (en) * 2010-12-21 2013-10-03 Sanofi-Aventis Deutschland Gmbh Drug delivery device with housing comprising frangible zone
US20130261555A1 (en) * 2010-12-21 2013-10-03 Sanofi-Aventis Deutschland Gmbh Drug Delivery Device with Housing Comprising Frangible Zone
WO2022171343A1 (fr) * 2021-02-15 2022-08-18 Shl Medical Ag Supports de seringue

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