Improved vent assembly for a wearable drug delivery device

Abstract

A vent assembly for a drug delivery device reservoir unit is described, the vent assembly comprising: a reservoir unit housing defining an interior volume separate from an exterior with a bottom wall, a viscous patch assembly, wherein the bottom wall forms a recessed surface creating a cavity, and a through hole fluidically connecting the cavity with the interior volume of the reservoir unit housing. A water-resistant and air-permeable pressure compensating membrane is sealingly attached to the bottom wall, wherein the through hole is overlaid by the pressure compensating membrane, and wherein the cavity opens to an opening to the exterior, and wherein the cavity contains a permeable spacer structure.

Description

Technical Field

[0001] This invention relates to a drug delivery device, and more particularly to a wearable patch pump for subcutaneous delivery of a fluid drug from a reservoir. Advantageous variations of the invention include improved designs of the drug delivery device or improved methods of manufacturing the drug delivery device. Background Technology

[0002] There are many diseases for which routine treatment requires subcutaneous administration of medication, and numerous drug delivery devices have been developed to support patients in delivering precise and controlled amounts of medication during self-administration. Delivery devices include those removed from the injection site after each medication event or delivery, and infusion devices with cannulas or needles that remain in the patient's skin for an extended period. For example, diabetes can be treated by patients administering insulin themselves using a variable-dose insulin pen or infusion pump. Alternatively, patch-type injection devices, wearable injection devices, or wearable pump patches are attached to or adhered to the patient's skin.

[0003] Moving away from traditional syringes, increasingly sophisticated devices are designed to support diverse therapies, ensuring safety and reliability while improving ease of use to the point where patients can administer medication themselves, minimizing time-consuming and costly interventions by trained healthcare professionals. Examples of medication delivery devices suitable for self-treatment include injection pens, autoinjectors, portable infusion pumps, and wearable patch pumps. Despite the technological complexity, keeping manufacturing and device costs as low as possible is a crucial requirement.

[0004] All devices used for subcutaneous drug delivery share a common feature: a reservoir for storing the fluid medication and a fluid pathway for carrying the medication from the device and into the patient's subcutaneous tissue. The impermeability of the fluid pathway is a fundamental requirement for ensuring safe and accurate delivery. Long-term infusion modes and reliable system monitoring rely particularly on controlled fluid pressure along the fluid pathway. While this is relatively easy to achieve with conventional syringes, it becomes challenging as device complexity increases. The requirements are further heightened by designing for self-administration, meaning use in non-sterile environments, by untrained medical personnel, or even by individuals with impaired vision or tactile abilities. The use of pre-filled cartridges, user-friendly filling ports, modular devices with disposable modules, and wearable devices with automated inserters are typical solutions for improving ease of use. Reducing the number of mechanical components and designing for easy assembly during manufacturing are typical approaches to minimizing costs.

[0005] US6,669,668B1 discloses a drug delivery device comprising a disposable reservoir and a reusable pump module. The drug is manually filled into the disposable reservoir using a standard syringe. An administration kit is used to deliver the drug from the pump into the patient's body.

[0006] A key step toward ease of use is eliminating the need for an application kit and designing wearable patch pumps that are small and have an adhesive patch to attach the pump to the patient during drug delivery. A typical patch pump design has a housing with a reservoir for holding the drug; a cannula for introducing the drug into the patient's body; and a needle assembly for establishing a fluid-tight connection between the reservoir and the cannula. For optimal ease of use, the cannula is made of a soft material, and an automated insertion mechanism with a rigid needle or cannula is built into the pump to insert the soft cannula into the patient's body for drug delivery. For a compact and fluid-tight design, the reservoir is largely built into the housing and needs to be filled from the outside before use. Numerous sealing elements are required to ensure the fluid path and the fluid-tight design of the housing. Special solutions are needed for the filling port where the drug is introduced into the reservoir and for the outlet port where the cannula passes from the inside of the housing to the outside for drug delivery. Wearability requires a compact overall design for the patch pump, which further increases the complexity of design and manufacturing. As the most sophisticated variant of subcutaneous drug delivery devices, semi-disposable patch pumps with internal automatic insertion mechanisms and soft cannulas open the door to the most complex therapies with potentially low cost and the highest level of ease of use. Among other applications, they are the preferred solution for intermittent insulin delivery in the treatment of diabetes.

[0007] Clearly, there is a strong need for wearable drug delivery devices that offer accurate and reliable drug delivery in a compact, easy-to-use, fluid-impermeable, and robust design, and can be manufactured at low cost. To achieve the best solution, all involved components must be designed accordingly.

[0008] US7,303,549B2 describes a completely disposable patch pump for percutaneous fluid delivery. While the concept includes an automated insertion mechanism for the injection needle and offers a high level of ease of use, the lack of a reusable component results in the drawback of generating significant waste and increasing the cost of therapy.

[0009] US8,679,062B2 describes a semi-disposable patch pump, which describes a modular patch pump in which one of the modules can be reused to reduce waste. However, ease of use is affected by requiring the handling of several different modules and by the lack of an automated insertion mechanism for the injection needle.

[0010] US9,993,595B2 describes another example of a modular patch pump with a more compact design. Again, the loss of an automatic insertion mechanism impacts ease of use.

[0011] For wearable delivery devices, a compact design is particularly important. Due to the advantageous manufacturing properties and low density of plastics, the materials used in such wearable drug delivery devices are typically plastics.

[0012] In other technical fields, different types of materials are often combined to benefit from the advantageous properties of different materials. For example, US5,597,990B1 discloses an electrical switch integrated in a switch housing and designed to detect the presence of an electronic memory card in a card reader device. The housing of the switch housing carries two fixed electrical contact elements arranged laterally on either side of the housing. Each fixed contact element is made of folded metal blades, with its free end extending from the switch housing to form a terminal for connection and soft soldering onto a printed circuit board. The contact elements are partially embedded in the overmolded plastic housing of the switch housing.

[0013] WO03103763 discloses a patch injection device including an outer housing for housing a reservoir. The reservoir is closed by a needle insertion diaphragm and can be filled by an external filling device using a filling port located in the housing.

[0014] WO2017120251 discloses a filling assistance mechanism for a patch pump, which includes features to allow easier and more reliable filling of a reservoir located inside the patch pump. The reservoir is closed by a needle insertion diaphragm and can be filled through a filling port located in the pump housing. The external filling assistance mechanism includes a tapered opening for guiding a needle of an external filling device. The very existence of the filling assistance demonstrates that, in the context of integration into a patch pump, the filling port is cumbersome to use.

[0015] US2019 / 0091404A1 discloses a cartridge-based drug delivery device in which a reservoir has a sealing membrane at its outlet. The membrane is punctured by the needle assembly to connect the reservoir outlet to a needle assembly and to prepare the pump for drug delivery. Such membranes can be difficult to manufacture in a compact design.

[0016] US6,699,218B2 describes a patch pump with a flexible sleeve and a rigid sleeve, the rigid sleeve being axially slidable within the flexible sleeve for insertion. All connections along the fluid path are designed to prevent leakage, but no solution is given on how to design the interface between the two sleeves to provide impermeability at a specified closure pressure. Impermeability at a specific closure pressure is necessary for reliable detection of closure in the fluid path.

[0017] The most common method for sealing the outlet port is by puncturing the diaphragm. One such arrangement is disclosed as part of an infusion kit in EP1390089B1. More complex designs of patch pumps with automatic insertion mechanisms open up additional possibilities for new solutions by expanding on this basic concept and optimizing the outlet port assembly for the specific requirements of the application.

[0018] EP1682203B1 discloses an outlet port assembly for a patch pump with a flexible sleeve and an insertion mechanism. The disclosed assembly includes numerous sealing components, making it more expensive to manufacture and not optimal for production.

[0019] US7,771,412B2 describes an environmental seal for a fluid delivery device, wherein the outlet port is designed as a cap comprising two distinct components and mounted within a housing. While both molding references are cited as methods to improve manufacturability and reduce costs, the proposed outlet port is quite complex. A soft plug is retained inside the cap and is not arranged in a manner that allows for combination with other functions for further optimization.

[0020] In patch pumps with automatic insertion mechanisms, a fluid connection is established between the reservoir and the cannula's output during pump manufacturing. This open path can affect the accuracy of drug delivery and also the functionality of the filling process. Therefore, it is desirable to close this path until drug delivery is intended to begin. The goal is to provide an easy-to-use and cost-effective solution for closing the outlet port.

[0021] US7,018,360B2 discloses a semi-permeable outlet plug for supporting the filling and pre-filling of a patch pump with a needle insertion mechanism. The plug may be a sheet of adhesive release liner attached to an adhesive patch. While simple, this concept is prone to tearing of the semi-permeable sheet during plug removal and requires a solution with improved reliability and therefore improved ease of use.

[0022] US6,749,587B2 discloses a patch pump in which the adhesive is arranged in a continuous ring surrounding an outlet port assembly to provide a protective seal around penetrated skin. Again, this simple concept can be extended to include other functions and to find the overall optimal solution.

[0023] EP3251585A1 discloses an adhesive patch assembly for a patch pump, which includes a structure for improving the reliability of the connection with the patient's body by allowing air and moisture to pass from the surface of the skin to the environment. This concept is also scalable and can be combined with other functions to achieve optimal reliability and ease of use.

[0024] US2002175062A1 relates to a switching device for a pump, the switching device including a switch and an illumination device, wherein a minimum force must be applied to the switch before a switching signal is generated; and covers a method for operating the illumination device such that the illumination device emits different light signals depending on at least one of the switching state of the switch and the operating state of the pump. Figure 1 An embodiment depicting a circular window, including a ventilation device, on the lateral side of a pump housing.

[0025] US2004092873A1 discloses an external infusion device with a ventilated housing for infusing fluid from a reservoir into the body, comprising a drive system, a housing, electronic control circuitry, and at least one vent port. The drive system is operatively coupled to the reservoir to infuse fluid into the body. The housing is adapted for use on the exterior of the body and is sized to accommodate at least a portion of the reservoir. Additionally, the drive mechanism is at least partially housed within the housing and operatively coupled to at least a portion of the reservoir within the housing. Furthermore, the housing is sized for user carrying without significantly restricting mobility. The electronic control circuitry is coupled to the drive system to control the infusion of fluid into the body. Moreover, the housing has at least one vent port that allows air to enter and exit the housing and prevents liquid from entering the housing through the at least one vent port.

[0026] WO04006981A2 discloses an apparatus for delivering fluids (such as insulin) to a patient. The apparatus includes a flow path having an outlet port assembly adapted for connection to a percutaneous patient access tool, and a reservoir connected to the outlet port assembly. The apparatus also includes a flow restraint system having an air removal filter in communication with the flow path that allows air to leave the flow path and prevents fluid from leaving the flow path, and a flow restraint positioned within the flow path between the air removal filter and the outlet port assembly. Among other features and advantages, the flow restraint system of the present invention allows for the purging, or "pre-filling," of air from the flow path of the fluid delivery apparatus prior to operation, enabling the device to precisely deliver a desired volume of fluid.

[0027] WO05077438A1 discloses an external infusion device enclosed in a multi-shell housing. A first housing, enclosed within an outer wall, houses a liquid reservoir and a drive mechanism. A second housing houses a pump and electronics for controlling the drive mechanism to dispense liquid from the reservoir according to a selected mode. A separate third housing houses one or more batteries. The first and third housings are ventilated to the atmosphere via a main vent with a hydrophobic barrier. The second housing is ventilated to at least one of the first and third housings via a secondary vent with a hydrophobic barrier. The hydrophobic barrier allows air to pass through and allows pressure equalization, but prevents liquid from passing through. Liquid entering one housing is prevented from flowing into other adjacent housings.

[0028] WO06061354A1 provides a medical device comprising a transdermal device unit and a processing unit. The transdermal device unit is adapted for application to the skin surface of a subject and includes a first housing, a transdermal device, and may include a flexible patch portion having an upper surface and a lower mounting surface adapted for application to the subject's skin. The processing unit includes a second housing with a lower surface and a processing assembly. The first and second housings are adapted to be secured to each other in such a way that the lower surface of the second housing is allowed free movement relative to the underlying skin surface or at least a portion of the patch. In this manner, the relatively flexible patch portion can adapt both statically and dynamically to the skin surface to which it is mounted, without being constrained in its movement by the generally more rigid processing unit.

[0029] US2016106914A1 discloses a fluid dispensing device comprising at least one reservoir for containing a therapeutic fluid, at least one other unit requiring at least partial communication with ambient air for operation, and at least one housing defining an interior to hold the at least one reservoir and the at least one other unit. The at least one housing has at least one ventilation port formed on one or more of its walls. The at least one ventilation port is adapted to direct or deliver air to maintain pressure balance between the air pressure inside the at least one housing and the ambient air pressure outside the at least one housing, and to provide communication with the ambient air to the at least one other unit (which requires air for operation of the at least one other unit).

[0030] US2010106091A1 discloses a non-stationary infusion pump assembly and housing, which thus has a cap and a base providing an enclosed cavity. The system includes a liquid pump in fluid communication with a supply source of a liquid medication. The pump and the supply source are received within the housing cavity. Furthermore, the system includes a seal that provides a liquid-impermeable seal between the cap and the base. A through passage extends from the enclosed cavity to the outside of the housing, and an infusion tube extends through the through passage. The liquid-impermeable seal is formed around the infusion tube. A vent is disposed within the housing that maintains a balanced pressure state between the enclosed cavity and the atmosphere, while simultaneously preventing contaminants from entering the enclosed cavity and preventing fluid from leaving the enclosed cavity.

[0031] US2014135693A1 discloses a medical multi-chamber pump with a pumping membrane and a ventilation channel to ensure membrane movement. The ventilation channel is covered with an air-permeable strip to protect the pump's interior from external contamination.

[0032] US2015080842A1 discloses a ventilated infusion device for infusing fluid from a reservoir into a body. The infusion device is connectable to an infusion kit adapter at a connection point. The infusion device includes: a drive mechanism for operatively engaging at least a portion of the reservoir; a housing sized to accommodate at least a portion of the reservoir, wherein the drive mechanism is at least partially or completely accommodated within the housing; and a sealing device that allows air to enter and exit the housing or housing compartment and prevents liquid from entering the housing or housing compartment through the sealing device. The sealing device is disposed at the drive mechanism, or at a location between a portion of the drive mechanism and the connection point of the infusion kit adapter, or at the connection point of the infusion kit adapter.

[0033] WO13188866A1 discloses a drug infusion device with pressure and temperature compensation, configured to maintain its intended drug delivery rate by monitoring atmospheric effects. The device may include one or more vents that allow gas to pass between the exterior and interior of the device housing. The device may also include one or more pressure and / or temperature sensors, readings from which can be used to determine malfunctions in the device's ventilation and / or pressure changes that could cause unintended over- or under-delivery of the drug.

[0034] WO14015257A1 discloses some embodiments of an injection pump system that can be configured to provide pressure balance between ambient air pressure outside the injection pump system and internal air pressure inside the injection pump system. In a particular embodiment, the injection pump system may be equipped with an air-transmittable, liquid-impermeable seal along the interface between the pump body and a cap device configured to be attached to the pump body.

[0035] WO14197389A1 discloses some embodiments of an infusion pump system that can be configured to provide a desired level of resistance to liquid inflow into the pump housing while providing air transferability to balance the pressure difference between the inside and outside of the pump housing. Furthermore, some embodiments can detect when the moisture level inside the infusion pump system is greater than or equal to a threshold level and can activate one or more patient safety measures.

[0036] WO14209621A1 discloses an invention that is generally directed to a novel ventilated fluid cartridge for medical infusion devices. The disclosed invention describes a cartridge having an internal ventilation structure and a hydrophobic ventilation material to allow pressure equalization between the reservoir chamber of the infusion device and the external environment without the need for expensive, difficult-to-maintain vents located in the housing of the infusion device.

[0037] US2016089505A1 discloses a system for managing pressure in a fluid reservoir chamber of a fluid delivery device. For example, the fluid delivery device includes a housing having a chamber for receiving a fluid reservoir. The fluid delivery device also includes a drive system housed within the housing. A portion of the drive system is movable for dispensing fluid from the fluid reservoir. The fluid delivery device includes a pressure management system, at least partially defined in a portion of the drive system, for venting air from the chamber.

[0038] EP3251585A1 discloses a body-mountable device, particularly a patch for a medical component, comprising a housing portion adapted to receive the medical component and having a bottom side, and further comprising a fastening device connected to the housing portion and adapted to attach the housing portion to a patient's body such that the bottom side faces the body, wherein a fluid guiding member is configured on the bottom side of the housing portion for guiding fluid flowing from the body to the periphery of the housing portion.

[0039] The disclosure of WO19034943A1 relates to a disposable module that can be coupled to a reusable module to form a pump for dispensing a substance to a user in a metering manner in a coupled state. The disposable module includes a housing that encapsulates the following components: a reservoir for receiving the substance to be dispensed; and an extendable sleeve, particularly a hard sleeve and / or a soft sleeve, which is fluidly connected to the reservoir at least after insertion or in a permanent manner (i.e., before insertion).

[0040] EP3928814A1 discloses a drug delivery device for medical therapy, wherein the drug delivery device has a housing with an outlet port opening and an outlet port assembly, wherein the outlet port assembly includes a rigid outlet port seal retainer and a soft outlet port seal, and provides both an impermeable fluid closure of the outlet port opening and an impermeable fluid connection between the housing and the rigid outlet port seal retainer.

[0041] EP2618867B1 discloses an infusion pump system comprising a disposable first part containing a drug cartridge and a reusable second part, the reusable second part including a motor and a second part containing a stop sensor, and without any part of the drug fluid path of the infusion pump system; wherein the disposable first part and the reusable second part are respectively configured such that the reusable second part can be brought into an operating position, in which operation of the motor causes drug to be dispensed from a drug reservoir, and wherein the thrust bearing can be a conventional ball bearing, an angular contact bearing, or a combined radial / thrust bearing. The thrust bearing may include a ball bearing, a cage guiding the ball bearing, a thrust washer, and a radial ball bearing riding on the thrust washer and also on the thrust surface of a drive gear. The radial ball bearing can withstand the thrust of the screw in the retraction direction. The radial bearing can be pressed onto a shaft and, to resist axial forces, pressed into the rear wall of a base, or more specifically, pressed into or engaged in an opening in a gear cover.

[0042] EP3705149B1 discloses an infusion pump for delivering fluid from a reservoir to a user's body. The infusion pump includes a housing and a drive mechanism comprising a motor and one or more drive members housed within the housing and operatively coupled to the reservoir to deliver fluid from the reservoir through a fluid path to the user's body. A drive shaft rotates a gear to transmit torque to a lead screw, causing the lead screw to rotate in a distal direction. The lead screw is mounted on bearings for support.

[0043] US10099005B2 discloses a drive mechanism for a drug delivery device, wherein the end of a screw extending from a second gear is supported by a bearing. The bearing is mounted in a bearing mounting hole in the gear cover. In the illustrated embodiment, the bearing mounting hole is a countersunk hole. The bearing is preferably a ball bearing. A first collar is disposed between the ball bearing and the second gear for axially positioning the ball bearing.

[0044] US2017043098A1 discloses a unit comprising a connecting sleeve and a threaded rod (which form a rigid unit), on which are mounted elements, namely, a guide sleeve, a bearing housing and a ball bearing ring, and a thrust sleeve. This unit constitutes a delivery arrangement that converts the rotational movement of an input component in the form of the connecting sleeve into thrust of a delivery element in the form of the thrust sleeve. Its input component can be detachably connected via a coupling to lock against relative rotation with respect to the drive arrangement. Additionally, it can be detachably connected via a coupling to lock against relative rotation with respect to the holding arrangement (i.e., the housing).

[0045] WO20020680A1 discloses a drug delivery device comprising: a housing with an opening; a piston rod having a proximal end and a distal end; at least a portion having an interface adapted to engage the opening for guiding the piston rod during movement of the piston rod distally or proximally relative to the housing; at least one first attachment element located at the distal end; and a bearing having at least one second attachment element for rotatable attachment of the bearing at the distal end of the piston rod, wherein at least one first attachment element and / or at least one second attachment element are resiliently deformable in a radial direction for snap-fit ​​engagement of the piston rod and the bearing, wherein the opening includes at least one portion having a profile adapted to receive at least one first attachment element and at least one second attachment element (if attached to each other), but preventing disengagement of at least one first attachment element and at least one second attachment element if received in the opening.

[0046] The objective of this invention is to provide an improved drug delivery device that is accurate, reliable, easy to use, and cost-effective, overcoming the shortcomings of the prior art or introducing alternatives to it. Several aspects of this invention contribute to an overall optimal solution. They are all applicable to all types of drug delivery devices, such as pen injection devices, patch injection devices, mobile pumps, or patch pumps.

[0047] An additional objective is to provide an improved assembly method for a drug delivery device, as disclosed in the corresponding claims.

[0048] definition The terms “substance,” “drug,” “pharmaceutical,” or “medicinal product” include any flowable medical preparation suitable for controlled administration via a device (such as, for example, a cannula or a hollow needle), and include liquids, solutions, gels, or fine suspensions containing one or more medically active ingredients. A pharmaceutical preparation may be a composition comprising a single active ingredient, or a premixed or co-formulated composition having more than one active ingredient in a single container. Pharmaceutical products include drugs such as peptides (e.g., insulin, insulin-containing drugs, GLP-1-containing drugs or derivatives, or similar preparations), proteins and hormones, active ingredients derived from or harvested from biological sources, hormone- or gene-based active ingredients, nutritional preparations, enzymes, and other substances in both solid (suspension) and liquid forms, as well as polysaccharides, vaccines, DNA, RNA, oligonucleotides, antibodies, or portions of antibodies, and suitable basic, auxiliary, and carrier substances.

[0049] The distal end or distal direction is defined by the orientation of the needle configured to penetrate the patient's skin. For an injection pen, this can be the injection needle, and the retaining needle or the end of the pen configured as a retaining needle is the distal end. For an infusion device, the distal end and distal direction face the needle configured to penetrate the patient's skin, which may be tilted or perpendicular to the axis of the device or about the axis of the device. The distal direction in an infusion device represents the direction in which the medication flows toward the insertion needle. The proximal direction or end is opposite to the distal direction or end.

[0050] The terms "injection system" or "injection device" refer to a device that is removed from the injection site after each pharmaceutical event or drug delivery process, while the term "infusion system" refers to a device with a cannula or needle that remains in the patient's skin for an extended period of time (e.g., several hours). Unless otherwise explicitly stated, the term "pump" refers to an infusion system, and in the context of this invention, typically refers to a patch pump.

[0051] In the claims, the word "comprising" does not exclude other elements or steps, and the indefinite article "a" or "an" does not exclude a plurality. For example, "sealing" or "protrusion" does not exclude the fact that there may be two "sealings" or "protrusions" that functionally or structurally satisfy the purpose of "sealing" or "protrusion". Summary of the Invention

[0052] In a first aspect of the invention, a modular concept for a semi-disposable patch pump is introduced, providing an optimal trade-off between ease of use and component reusability. This is achieved by reducing the number of components the user needs to handle to two (a storage unit intended for single use and a pump unit intended for multiple or continuous use). The fact that there are only two units minimizes waste while still minimizing the number of procedures the patient needs to perform to apply the pump.

[0053] The reservoir unit includes a reservoir unit housing and a substrate mounted on an adhesive patch, wherein the substrate is attached to or integrated into the bottom of the reservoir unit housing, and includes all components intended for single use, particularly all components in contact with the medication and the adhesive patch. The medication delivery component will typically include a reservoir with a reservoir outlet, a pump mechanism, and a needle assembly connected to the reservoir outlet to transport the medication from the reservoir into the patient's body. For optimal ease of use, the reservoir unit further includes an inserter assembly comprising an automatic insertion mechanism to insert the needle into the patient's body without the user applying any force. For example, the pump mechanism may include a plunger movably mounted in the reservoir, allowing the medication to be expelled through the reservoir outlet by moving the plunger. Any kind of energy can be used to drive the automatic insertion mechanism, either energy stored in the reservoir unit (like a preloaded insertion spring) or energy from an external source (like rotation generated by the pump unit). This also includes the possibility of using the same drive unit used to drive the pump mechanism to drive or release the automatic inserter. The pump unit includes all components intended for repeated or continuous use, such as the pump unit housing, an electrical power source (like a rechargeable battery), a drive mechanism with a drive element for driving the pump mechanism in the storage unit, acoustic and / or visual and / or tactile elements for user interaction, a communication unit for sending and / or receiving data from other system components, and a control unit for controlling the device. In embodiments where the pump mechanism is a plunger movably mounted in the storage unit, the drive element may be, for example, a combination of a motor, gears, and a threaded rod cooperating with the plunger rod.

[0054] The pump unit is further configured to be releasably attached to the reservoir unit. An important aspect of the invention is how the reservoir unit and the pump unit are mechanically connected. The connection must be secure and reliable, allowing for easy separation of the pump unit and the reservoir unit for replacement of disposable parts, while ensuring optimal safety and reliability in the event of accidental separation or removal of the pump unit during normal use.

[0055] When the two units are connected, the patch pump is preferably formed into a substantially edgeless shape for optimal wearability and to prevent accidental removal of the patch pump from the patient's body. The external shape covering the pump components during normal use also helps prevent accidental detachment of the pump unit from the reservoir unit. Still for optimal ease of use, the mechanical interface between the reservoir unit and the pump unit preferably includes a bayonet connection, where releasing the connection requires no button press or slider movement, while still ensuring the mechanical connection has the optimal rigidity and minimal axial clearance required for accurate and reliable drug delivery.

[0056] The pump unit is simply pushed onto the reservoir unit at an angle of at least 5 degrees (preferably at least 15 degrees) and folded down onto the plane of the substrate, thereby closing the pump's substantially edgeless outer surface. The closing movement of the reservoir unit is essentially a rotation about an axis defined by the bayonet connection. To open the bayonet, the user pulls the side of the reusable unit away from the axis of rotation facing the bayonet, whereby the pump unit is lifted from the plane of the substrate to release the pump unit.

[0057] While the concept of a semi-disposable patch pump as described in this invention encompasses any type of locking mechanism for bayonet connections, mechanisms that allow unlocking and opening of the connection via the same processing steps are particularly easy to use and are therefore preferred. Examples of this type of embodiment include mechanical latches, magnetic locks, or a pair of Velcro® hook and loop fasteners that engage and disengage via simple push and pull.

[0058] Although the patch pump's outer shape is optimized for wearability, unlocking and removing the pump unit can still occur if the patient's body part, to which the pump is attached, unintentionally brushes against the edge. The edge can slide under the patch pump on the open side, lifting the pump unit from the plane of the substrate. The locking mechanism can be opened, and the pump unit can be brushed off the patient's body. To avoid this type of accidental removal, an improved embodiment of the patch pump includes a substrate that extends from the bottom of the reservoir housing between the open side and the bayonet axis in the direction of the pump unit. While this extended substrate effectively reduces the risk of accidental removal of the pump unit from the reservoir unit, it can make it more difficult for the patient to intentionally remove the pump unit. Therefore, a further improvement to the patch pump according to the invention is a cut at the edge of the substrate. The effect of the cut is that the patient's fingers can at least partially slide under the pump unit on the open side of the pump, while the longer edge remains on the outside. To achieve this effect, the cut will have a length of 5 mm to 30 mm, preferably 15 mm to 25 mm, and a width of 1 mm to 10 mm, preferably 3 mm to 5 mm.

[0059] The patch pump according to the invention minimizes the number of processing steps required to apply the pump, while also minimizing waste generated by the therapy. Additional features ensure the patch pump is safe to use, despite its ease of use.

[0060] In a second aspect of the invention, a concept for a compact design of a drug delivery device is introduced. This objective is achieved by a drug delivery device comprising a reservoir for containing liquid drugs, a needle assembly for delivering the drugs, and a base frame.

[0061] According to a second aspect of the invention, a drug delivery device includes a base frame comprising a conductive connector structure including an electrical contact region for establishing an electrical connection between the base frame and an external device. The base frame further includes a non-conductive body injection-molded around the connector structure, such that the electrical contact region can be contacted by the external device from the outside of the non-conductive body. The base frame may be further integrated into or form part of the housing of the drug delivery device.

[0062] The present aspect of the invention may further include the base frame itself of the drug delivery device as described in the preceding paragraphs, the base frame including a conductive connector structure including an electrical contact area for establishing an electrical connection, and a non-conductive body injection-molded around the connector structure such that the electrical contact area can contact from the outside of the non-conductive body, characterized in that the non-conductive body includes a guide member for guiding the movement of a needle assembly, which is combined with the non-conductive body to form an integral component.

[0063] According to existing techniques, different electrical contact elements and supports for holding the contact elements in place within the drug delivery device are mechanically connected to each other, for example, by thermal riveting, riveting, insertion or pressing into sockets, or by using snap-locking connections. The different electrical components are complex to handle. Furthermore, establishing electrical connections between different components requires a considerable number of manufacturing steps.

[0064] According to a second aspect of the invention, the base frame serving as a support structure allows for a substantial reduction in the number of individual components and also allows for the integration of several functions into a single assembly. The electrical connector structure includes electrical conductors, contacts, traces, or strips adapted to establish electrical connections between electrical components supported or held by the non-conductive body. The connector structure can be formed from only one component, or a small number of components. The non-conductive body of the drug delivery device is preferably injection molded around the connector structure. This concept allows for the integration of various other support elements into the non-conductive body, forming a monolithic assembly with expanded functionality. For example, other support elements may be support pins for printed circuit boards, holding elements for securing batteries to the non-conductive body, guiding elements for guiding other movable elements of movable needle assemblies or inserter mechanisms, or stop elements for stopping such movement. By reducing the number of components, the base frame according to the invention allows for a compact design of the drug delivery device.

[0065] The conductive portions or connector components of the connector structure can be made of any conductive material, such as metal, metal alloy, conductive plastic, or conductive composite material. The connector structure provides an electrical connection between a component supported by a base frame and an external device that is inseparably or releasably connected to the electrical contact area of ​​the base frame. Furthermore, the connector structure can provide electrical connections between various electrical and / or electronic components supported or guided by the base frame.

[0066] A connector structure may include only a single conductive portion or connector component, or it may include multiple conductive portions or connector components. Preferably, the connector structure includes at least two separate connector components that are electrically insulated from each other. In this case, all connector components of at least one connector structure are preferably manufactured as a single component, such as a single metal sheet, in a first production step. The shape of the sheet will include all connector components plus some connecting bridges between the connector components to form a single conductive component. In a second production step, the conductive sheet or component is overmolded to form a monolithic component with a non-conductive frame that holds all connector components and connecting bridges. In a third production step, the connecting bridges are removed, for example by punching, resulting in a monolithic component containing a connector structure with one or more separate electrical paths. This manufacturing process is much easier and more efficient than overmolding techniques that embed two or more conductive connector components as separate components.

[0067] Electrical contact areas are integrated into the connector structure to form a single integral component. However, as mentioned above, the connector structure itself may include more than one conductive portion or connector component. Preferably, a first electrical contact area is formed in a first connector component, and a second electrical contact area is formed in a second connector component, wherein the first and second electrical contact areas are different in current and are separate from each other. In this case, the first electrical contact area is preferably adapted to connect to the positive terminal, and the second electrical contact area is adapted to connect to the negative terminal.

[0068] The non-conductive body of the drug delivery device is injection molded around the connector structure and thus at least partially covers the connector structure. The connector structure is therefore supported or held by the non-conductive body. This allows the connector structure to be securely placed inside, for example, the housing of the drug delivery device. The non-conductive body can be made of non-conductive plastic, non-conductive composite material, or any other non-conductive injection moldable material.

[0069] The non-conductive body is preferably a single integral component. Several elements, such as, for example, retaining elements, guide rails, mechanical stops, support elements, or bearing pins, are integrated into the non-conductive body. This means that the elements are preferably made of the same material as the non-conductive body.

[0070] The non-conductive body is injection molded around the connector structure, allowing the electrical contact areas of the connector structure to make contact from the outside of the non-conductive body. This means that the non-conductive body is designed not to prevent the electrical contact areas of the connector structure from making contact with the intended connection contacts. For example, the electrical contact areas of the connector structure can be designed in the form of an arm or rod protruding from the non-conductive body, or the non-conductive body can have openings or recesses that allow external devices to contact the electrical contact areas through the openings or recesses.

[0071] The connector structure and the non-conductive body injection-molded around the connector structure can form a hybrid component or a monolithic component manufactured using a two-component (2C) molding technique. This technique is also known as insert molding or overmolding.

[0072] The drug delivery device can be an infusion system or an injection system. For example, the drug delivery device can be an injection pen, or it can be a patch injection device that can be applied to the user's skin for the duration of the injection. For example, the infusion system can be a conventional medical drug pump, such as an insulin pump with an infusion kit, or it can be a drug patch pump without an infusion kit that can be directly attached to the user's skin.

[0073] In a preferred embodiment, the drug delivery device is a patch pump comprising a reusable portion and a disposable portion. The reusable portion may include a drive mechanism and a control unit. The disposable portion is adapted to be replaced after each infusion and may include a reservoir with the drug, a hybrid assembly with a needle assembly, a cannula moving assembly for moving at least a portion of the needle assembly, and a base frame according to the invention. In this series, the cannula moving assembly will include the relevant portion for handling the movement of the needle assembly of the inserter assembly, particularly for rigid cannulas and for flexible cannulas, a retainer.

[0074] In a preferred embodiment, the non-conductive body forms a guide member for guiding the movement of the needle assembly itself or the cannula moving assembly. The term "forms" means that the guide member is integrally formed within the non-conductive body as a single component. Therefore, the guide member is made of the same material as the rest of the non-conductive body.

[0075] The guide component can guide the movable portion of the needle assembly or the sleeve moving assembly to move along a linear or straight movement path, along a curved path, along a rotational path, or along a combination of linear, curved, and rotational movement paths. The guide component can be implemented, for example, in the form of a rail, nut, protrusion, or profile.

[0076] Because the guide component is formed as a single integral part within the non-conductive body, no device is required to connect the guide component to the non-conductive body; for example, snap-fit ​​or threaded connections are not necessary. The guide component allows for easy and rapid movement of the cannula and / or other parts of the needle assembly, for example, from a starting or initial position to an extended or inserted position, where the cannula is inserted into the user's skin.

[0077] Preferably, the guide element is a linear guide for guiding the needle assembly itself or a portion of the cannula moving assembly along a linear movement path. "Linear" means the movement path is a straight line, causing the needle assembly to move along a straight line. The guide element may include one or more guides. Preferably, the guide element includes at least one guide adapted to engage with a corresponding mating part (e.g., a groove) of the needle assembly and / or the cannula moving assembly.

[0078] Advantageously, the non-conductive body may include an end stop surface integrated into the non-conductive body as a single integral component, wherein the end stop surface is adapted to restrain the movement of the needle assembly or cannula movement assembly in a first direction. The end stop surface is integrally formed in the non-conductive body. Preferably, the end stop surface defines an extended or initial position of the needle assembly. The needle assembly is movable from the initial or initial position to an extended or inserted position, at which the cannula pierces the user's skin. For example, the end stop surface may be a cushioning stop, a buffer, or simply an element protruding in the direction of movement of the needle assembly.

[0079] Preferably, the connector structure is primarily made of metal. This means that the connector structure is either entirely made of metal, or made of a combination of metal and other materials, a conductive composite material, or a combination of metal and additional non-metallic materials. Preferably, the connector structure is made from a single sheet of conductive metal. This allows for easy and efficient production of the connector structure.

[0080] In this case, the connector structure is preferably formed by punching and bending. This means that the outline of the connector structure is defined in the first step by punching the connector structure from a metal sheet, and in the second step, the connector structure is further formed by bending. If the connector structure includes more than one connector component, the connector components are initially mechanically connected to each other via auxiliary or temporary bridging elements or connectors. After the non-conductive body is injection molded around the circuit, these bridging elements are eliminated or interrupted by a stamping step. This means that the finished connector structure may include several electrically different and separate connector components or other electrical paths. In this way, the connector structure can be manufactured efficiently and at low cost.

[0081] In a preferred embodiment, the connector structure includes at least two electrical contact areas. Preferably, each of the at least two electrical contact areas is arranged on a resilient element or contact arm of a connector component. This means that the connector structure includes at least two connector components, each including a resilient element or contact arm that carries the electrical contact area. Therefore, when an external element mechanically contacts and electrically contacts the electrical contact area, the electrical contact area can bounce or flex. This facilitates a reliable electrical connection between the external contact element and the electrical contact area of ​​the connector structure. The external contact element may belong to other devices, such as a charger, or may belong to any other system component that can be connected to the connector structure, such as a unit of a modular pump or an additional device for monitoring the injection or infusion process.

[0082] Preferably, the drug delivery device includes a switching arm that flexibly protrudes outside the base frame and is formed as a single integral component within the first connector member. Therefore, the switching arm is made of the same material as the connector structure. The switching arm is preferably capable of direct or indirect electrical contact with the second connector member. The first and second connector members are electrically separated from each other. If the switching arm makes electrical contact with the second connector member, an electrical connection is established between the first and second connector members, and thus electrical signals can be transmitted. Therefore, the switching arm can be switched between a conductive and a non-conductive state via a movable sleeve assembly.

[0083] For example, the generated signals can indicate whether a release button has been pressed, whether an external device has been connected, or whether the needle assembly has moved to a specific position. Of course, the switching arm must be positioned so that the button, external device, or needle assembly can mechanically contact the switching arm to switch the lever between a conductive and a non-conductive state.

[0084] Advantageously, the switching arm can be switched via the pin assembly or via the inserter assembly, such that the switching arm establishes an electrical connection or interrupts the existing electrical connection between the first connector component and the second connector component.

[0085] The switching arm is advantageously positioned beside or near the movement path of the cannula moving assembly or the needle assembly, such that elements of the cannula moving assembly or the needle assembly (e.g., edges, protrusions, actuators) can mechanically contact and thus switch the switching arm. The conductive (electrically connected) or non-conductive (electrically disconnected) state of the switching arm can indicate whether the needle assembly is in the initial position or the extended position, or simply no longer in the initial or extended position.

[0086] In a preferred embodiment, the non-conductive body may be made primarily of plastic. The non-conductive body may comprise plastic only, or primarily plastic and other non-conductive materials or composites. In either case, the material of the non-conductive body is injection moldable and can therefore be used to overlay molded connector structures.

[0087] Furthermore, the non-conductive body may include holding elements for securing a battery integrated into the non-conductive body as a single unit. Additionally, the connector structure may include battery contact elements for electrically contacting the secured battery integrated into the connector structure as a single unit. The holding elements may be, for example, arms, clamps, holding tabs, or tongues. Therefore, the battery can be reliably held relative to the non-conductive body. The battery may be a button cell, a conventional cylindrical battery, or a rechargeable battery. If the battery is held and held in place by the holding elements, the battery mechanically contacts and electrically contacts the battery contact elements of the connector structure. The battery contact elements may be implemented in the form of, for example, pins, tabs, tongues, or arms, and may be integrated into the connector structure as a single unit.

[0088] Preferably, the connector structure forms at least two battery contact elements. For electrical contact with the battery, a first battery contact element is adapted to be connected to the positive terminal of the battery, and a second battery contact element is adapted to be connected to the negative terminal of the battery.

[0089] The present invention further relates to a base frame for a drug delivery device having a needle assembly, and preferably an inserter assembly having a cannula movement assembly. The base frame includes a conductive connector structure comprising an electrical contact area for establishing an electrical connection and a non-conductive body injection-molded around the connector structure, such that the electrical contact area can contact from the outside of the non-conductive body. The non-conductive body includes a guide member for guiding the movement of the needle assembly or the cannula movement assembly, the guide member being integrated into the non-conductive body as a single integral component. Furthermore, the present invention relates to a hybrid assembly comprising the base frame, cannula movement assembly, and needle assembly described above.

[0090] In a preferred embodiment, the hybrid assembly further includes a heating assembly or melt release module with a heating element for releasing the puncture process utilizing the needle assembly. The heater assembly is supported by a non-conductive body.

[0091] The release of the puncture process may involve linear or rotational movement of the needle assembly from an initial or starting position to an extended position, where the cannula punctures the user's skin. The heating element of the heater assembly preferably melts or disconnects a fuse that holds the biased needle assembly or cannula moving assembly in its initial position. If the fuse melts or disconnects, the insertion trigger or retaining device of the hybrid assembly disconnects or expands, allowing the biased needle assembly or cannula moving assembly to freely move the cannula and puncture the user's skin using a portion of the needle assembly.

[0092] The heater assembly having a heating element is preferably directly or indirectly connected via another element supported by and arranged on the non-conductive body.

[0093] To control the insertion process, the hybrid assembly preferably includes a printed circuit board (reservoir unit printed circuit board, PCB-RU) supported and held by a non-conductive body. The heating elements and other control elements of the heater assembly may be arranged on the PCB-RU.

[0094] Preferably, the retaining structure for rigidly holding the PCB-RU to the non-conductive body is integrated into the non-conductive body as a single integral component. The structure may include pins, tabs, or arms forming a single integral component. The PCB-RU may be secured to the retaining structure, for example, by adhesive, by thermal riveting, or by snap-locking.

[0095] The design of seals for drug delivery devices is not an isolated task. Fluid impermeability is always defined for a specific area or volume based on pressure requirements derived from the intended functionality. To achieve the design of this invention, the following pressure requirements are specified: - Allows the reservoir to be successfully filled through the filling port in the housing, with at least the reservoir seal and the filling port seal being impermeable to fluid at a filling pressure of at least 6 bar.

[0096] - To allow for successful occlusion detection, the fluid path of the agent must be sealed against an occlusion pressure of at least 2 bar to prevent fluid penetration.

[0097] - Successful prevention of intrusion from the environment, at least the housing seal is impermeable to fluids under environmental overpressure of at least 0.24 bar.

[0098] It is of particular importance to meet these requirements and to find the overall optimal solution for sealing at all interfaces related to the function of the drug delivery device. It is further apparent that the pressure requirements given above are merely examples to illustrate the advantages of the invention, and the application of the concepts described herein should in no way be limited to specific pressure ranges.

[0099] In a third aspect of the invention, a concept for improving the fill port assembly is described, which overcomes the disadvantages of the prior art. The improved fill port assembly ensures impermeability at fill pressure, facilitates easy assembly, improves device life and robustness, and can additionally secure the reservoir relative to the housing.

[0100] This objective is addressed by a drug delivery device for delivering a drug from a reservoir to a patient, the device comprising: a housing including a wall separating an internal volume from an external one; a reservoir located within the internal volume; and a filling port assembly located within the wall of the housing and accessible from the outside for filling the reservoir, the filling port assembly including a tapered opening for receiving a needle, and a punctureable filling port seal separating the reservoir from the outside, characterized in that the filling port assembly includes an insert adapted to be received by a passage in the wall of the housing, and wherein the filling port seal satisfies a sealing function between the housing and the reservoir. The seal between the housing and the reservoir is configured to ensure that no fluid can pass between the reservoir and the wall of the housing.

[0101] The present aspect of the invention is preferably applied to a drug delivery device for delivering a drug from a reservoir, the drug preferably being a liquid or a solid reconstituted prior to injection. The reservoir may be a cylinder, a non-collapseable reservoir, or a collapsible reservoir made of a flexible material. The drug delivery device includes a housing comprising a wall separating an internal volume from an external one. The housing may be constructed of any number of components joined together to form a substantially closed shell surrounding the internal volume. The reservoir is located within the internal volume. A filling port assembly is located within or is a portion of the wall forming the housing and is accessible from the outside for filling the reservoir. The reservoir may be filled at the factory or by a user prior to use. Preferably, the reservoir is a multiple-use reservoir. Alternatively, the reservoir is filled only once and the unit including the reservoir is discarded after use. The filling port assembly includes a conical or tapered opening adapted to receive a needle. The conical opening facilitates the entry of a needle from a filling or transfer device (e.g., a syringe) for filling the empty reservoir with the drug. The fill port assembly includes a puncturable fill port seal separating the reservoir from the outside. The puncturable fill port seal may include a puncturable diaphragm. The fill port seal or the diaphragm of the seal can be punctured by a needle for filling the reservoir. Furthermore, the fill port assembly includes an insert adapted to be received by a passage in the wall of the housing, or received within the fill port seal, whereby the latter is received within a passage in the housing. The fill port assembly is assembled from the outside of the housing. The fill port seal provides a seal between the housing and the reservoir. The fill port seal may provide multiple seals to different sections or components within the drug delivery device, and the seals may be a direct seal between the housing and the reservoir, or an indirect seal via other housing portions. Combining multiple seals in the fill port assembly reduces the number of parts required. The advantage of using an insert as part of the fill port assembly is that, during assembly, the insert is inserted from the outside into a passage in the wall, thereby potentially securing other portions (e.g., housing portions) or components (such as the reservoir) relative to at least a portion of the housing of the drug delivery device or the reservoir unit of the drug delivery device, and simultaneously establishing one or more seals. Therefore, the filling port assembly combines the following features: filling of the empty reservoir, sealing of the reservoir relative to the housing, and securing of the cylinder or reservoir. The advantage of using a separate insert from the housing is that the two parts can be adapted to their specific needs. The insert can be made of a different material than the housing, thus reducing manufacturing costs, or made of materials with different stiffness or abrasion resistance, which reduces the risk of particle abrasion, needle clogging, or needle damage. The tapered opening further facilitates needle insertion through the filling port, especially for visually impaired users.

[0102] The insert of the drug delivery device preferably includes a tapered opening that extends from a base. The tapered opening defines a longitudinal axis, and the base is preferably connected to a larger diameter inlet of the cone and oriented perpendicular to the longitudinal axis. The outer dimensions of the base fit into a first recess or recessed section of the housing or the wall of the housing. Thus, the tapered opening of the insert is adapted to receive and guide a needle tip, for example, toward a diaphragm of a filling port seal. The tapered opening has an angle relative to the longitudinal axis. The opening of the cone is wide to facilitate the entry of the needle tip. The cone angle between the longitudinal axis and the cone surface ranges from 20 degrees to 40 degrees, more preferably from 25 degrees to 35 degrees, and most preferably, the cone angle is approximately 30 degrees.

[0103] The filler port seal is preferably sandwiched between the base of the insert and the wall of the housing to provide a first seal between the insert and the housing. The first seal prevents fluid and / or gas from leaking from the inside of the housing to the outside, or from entering the housing from the outside, causing back contamination. The first seal may be a sterile design to protect the inner portion of the housing from the environment. The first seal can improve the shelf life or lifespan of the device.

[0104] The filling port seal includes a flange or edge, preferably made of a compressible or elastic material (such as an elastomer). The flange is adapted to receive in a second recess or recessed section of a passage within the wall surrounding the housing. A first recessed section for the insert may differ from the second recessed section of the flange for the filling port seal. Both recessed sections surround the passage, and the second recessed section for the flange may be deeper than the first recessed section for the insert. The second recessed section for the flange is adapted to receive the flange or edge, and preferably has a smaller lateral dimension than the first recessed section adapted to receive the base of the insert. Preferably, the flange is sandwiched between the insert (or the base of the insert) and the wall. The first seal is preferably an axial seal oriented along the longitudinal axis of the tapered opening and located between the base of the insert and the recessed section of the housing or the passage surrounding the housing. The flange of the fill port seal is received in a second recessed section in the wall to secure the fill port seal and prevent lateral movement, and to align portions (e.g., the passage in the housing, the fill port seal, and the insert) prior to final assembly and / or fixation of the cylinder. The wall of the housing in the second recessed section, configured to receive the base of the fill port seal and / or the insert facing the fill port seal, may have raised or protruding structures to locally compress the resilient sealing material of the flange.

[0105] The drug delivery device can be further improved by additionally sealing the filling port of the reservoir's inlet. The reservoir inlet is preferably oriented parallel to the longitudinal axis of the filling port assembly (e.g., parallel to the longitudinal axis of the tapered opening), and once the device is assembled, the reservoir inlet is aligned with a passageway in the housing. The reservoir inlet is preferably oriented perpendicular to the reservoir's longitudinal axis. The reservoir inlet is also aligned with the tapered opening and the diaphragm portion that seals the filling port, such that needle penetration of the diaphragm ensures that the drug can be filled into the reservoir. Thus, the fluid port assembly provides a fluid-tight closure of the reservoir's inlet, and therefore prevents leakage of the drug from the reservoir into the housing or to the outside. The fluid port assembly also prevents contaminants from entering the reservoir from the outside and may serve as part of a sterile barrier.

[0106] The filling port seal of the drug delivery device can provide a second seal between the filling port seal and the inlet of the reservoir, and the seal is preferably oriented in a radial direction perpendicular to the longitudinal axis of the tapered opening. The second seal is preferably axially displaced from the first seal. By positioning the two seals in different locations, two sealing functions in one part are achieved, both of which have (independent) sealing performance, and the materials or dimensions can be adapted to specific needs.

[0107] Preferably, the insert and the fill port seal secure the reservoir relative to the housing. Thus, the reservoir, which preferably already exists inside the housing, is secured by inserting the fill port seal and the insert from the outside into the housing. The securing may be based on a form-fit, alternatively using a friction fit or a force fit. The securing may additionally benefit from a snap-fit ​​connection between the reservoir or its inlet and at least one of the portions forming the fill port assembly. The securing preferably uses the fill port assembly or a portion thereof, at least partially located inside the inlet of the reservoir. Alternatively, the neck section or body of the reservoir may be used for securing. The additional use of the fill port assembly for reservoir securing implies a sealing and securing combination, which improves device assembly and reduces the number of parts.

[0108] Preferably, the filling port seal includes an opening extending from the flange and terminating in the pierceable diaphragm. The opening may be formed by a cylindrical section that connects the pierceable diaphragm to the flange of the filling port seal. Preferably, the pierceable diaphragm forms the end of the opening. The cylindrical section preferably connects the first seal and the second seal.

[0109] Preferably, the insert of the drug delivery device includes a sleeve extending from a tapered opening, the sleeve beginning at a narrow section of the tapered opening, and the sleeve is adapted to be received within an opening of the fill port seal. Thus, the base of the cone can be attached to the sleeve. The sleeve is attached to the narrow end of the tapered opening and preferably extends along the longitudinal axis of the cone. The sleeve guides the needle tip from the tapered opening toward a puncturable diaphragm of the fill port seal. Guiding ensures that during reservoir filling, the diaphragm is punctured perpendicularly to the membrane forming the diaphragm, preventing tearing of the diaphragm and leakage along the needle. Guiding also prevents the needle from contacting the inner wall of the inlet, which would carry the risk of scraping particles from the inlet wall and reducing the depth of puncture. Furthermore, the sleeve of the insert is coaxially arranged within an opening formed by a cylindrical section of the fill port seal. The sleeve of the insert, the cylindrical section of the seal, and the inlet of the reservoir can be coaxially arranged for insertion of the insert and seal during assembly, and for reservoir fixation of the assembled device. Since the base of the insert is fixed in at least one of the recessed sections of the housing and prevents lateral movement of both the fill port seal and the reservoir, the reservoir can be secured by installing the fill port assembly.

[0110] Preferably, the outer surface of the filling port seal or the outer surface of the cylindrical section is at least partially received in the inlet of the reservoir.

[0111] Preferably, the outer surface of the cylindrical section is press-fitted into the inlet of the reservoir, thereby a) establishing a second seal (due to the resilience or partial resilience of the outer surface of the cylindrical section) and b) securing the reservoir to prevent lateral movement. The fill port assembly secures the reservoir such that a shock absorber exists between the reservoir and the housing, preferably due to the elastic properties of the outer surface of the cylindrical section engaging the reservoir's inlet. This is advantageous for the device because it improves its impact resistance, for example, during drop tests.

[0112] Inserts for drug delivery devices are made of metal, such as steel, preferably stainless steel or aluminum. Alternatively, inserts are made of plastic material coated with a metal layer, or of plastic material reinforced with mineral fillers such as glass, zirconium oxide, or alumina particles. One advantage of using metal or reinforced plastic is that it prevents the needle tip from scraping the particles from the insert, or even prevents the needle tip from getting stuck in the insert. Another advantage of using metal or reinforced plastic is that it improves the abrasion resistance of the insert to the extent that the reservoir can be reused multiple times; for example, the needle can be guided and inserted multiple times through the filling port assembly without damaging the insert. Therefore, the lifespan of the insert, and the device associated with it, can be improved, especially for reusable devices.

[0113] The fill port seal preferably comprises a thermoplastic polymer and an elastomer. Preferably, the elastomer surrounds the thermoplastic polymer. The advantage of using a thermoplastic polymer is that it has a high modulus, providing mechanical strength to secure the reservoir while improving fit during pump manufacturing. The advantage of using an elastomer is that its elasticity facilitates seal formation and, optionally, damping. Examples of thermoplastic polymers include polybutylene terephthalate (PBT), polycarbonate, or polycarbonate alloys such as cyclopentadiene, acrylonitrile-butadiene-styrene copolymer (ABS), or high-modulus polyurethane (PUR). Examples of elastomers include EPDM rubber, polydimethylsiloxane rubber PDMS (preferably in LSR form), elastomeric polyurethane (PUR), or thermoplastic elastomers (TPE). When a portion of the fill port seal may come into contact with a pharmaceutical agent, the thermoplastic polymer and elastomer are preferably selected to meet biocompatibility requirements according to ISO 10993. Thermoplastic polymers and elastomers are preferably injection molded using two-component injection molding, thereby reducing the number of parts because multiple functions are combined in a single part.

[0114] The insert for the fill port assembly, more preferably, includes a recess, opening, or cutout at its base configured to receive a retaining pin extending from the wall of the housing. The insert may include multiple recesses, openings, or cutouts adapted to engage multiple retaining pins. The retaining pins are preferably integrally formed on the housing and are made of a thermoplastic polymer. The retaining pins are oriented substantially parallel to the cone axis, and the engagement between the cutouts and the retaining pins ensures that, after installation, the insert is properly aligned with the other parts of the fill port assembly and the housing. The engagement between the retaining pins and the openings facilitates assembly and ensures that the insert is rotatably secured relative to the housing. The insert can be secured to the housing by thermally riveting at least one of the retaining pins, for example, by heating and deforming the retaining pins. This axial and rotational securing is essential for reliable and sufficient contact pressure of the fill port seal, and therefore for achieving the intended sealing function of the fill port up to a specified fill pressure.

[0115] The drug delivery method according to this aspect of the invention allows for assembly of the filling port from the outside of the housing, and the use of separate inserts for securing the diaphragm and reservoir. The inserts may be made of a material different from the housing material.

[0116] The present aspect of the invention also includes an improved method for assembling a drug delivery device having a filling port according to the above description, comprising the following steps: - Provides housing, reservoir, filler port seal, and insert. - Insert the storage device into the housing from the outside along an axis perpendicular to the cone's axis, then... - The filling port seal is inserted from the outside along the cone axis into the passage 211c in the wall of the housing, followed by... - The insert is inserted into the fill port seal from the outside, thereby clamping the fill port seal (preferably, the flange of the fill port seal) between the insert (preferably, the base of the insert) and the housing, and establishing a first seal and a second seal, and securing the reservoir to the housing.

[0117] The method may additionally include the following steps: The opening or cutout of the insert is positioned on a retaining pin extending from the wall of the housing of the drug delivery device or disposable unit, followed by thermal riveting of the retaining pin to secure the insert to the housing. Alternatively, the insert can be secured to the housing using ultrasonic welding, laser welding, adhesives, or thermal welding.

[0118] In a fourth aspect of the invention, a concept for an improved seal for a drug delivery device is described, the improved seal being located at the interface between the reservoir and the needle assembly that guides the drug from the reservoir to the cannula. The reservoir outlet seal design ensures impermeability at occlusion pressures, facilitates easy assembly, and enhances the lifespan and robustness of the device.

[0119] This objective is achieved through a drug delivery device comprising: a housing having a reservoir located inside the housing to contain a drug; a needle assembly having an inlet portion and an outlet portion; and a punctureable reservoir outlet seal; wherein the reservoir comprises at least partially rigid reservoir housing having a at least partially cylindrical reservoir outlet seal cavity integrated into the reservoir housing as an integral component; the reservoir outlet seal is at least partially cylindrical and configured to be inserted into the reservoir outlet seal cavity during the manufacture of the patch pump, to be punctured by the inlet portion of the needle assembly during manufacture, and to form an impermeable fluid connection between the reservoir and the inlet portion of the needle assembly. The at least partially cylindrical design of the reservoir outlet seal helps to ensure impermeability at filling and / or occlusion pressures, as well as a easier assembly process compared to other geometries. In a variation of this design, a soft reservoir outlet seal may be manufactured as an integral component together with the rigid reservoir housing using a two-stage injection molding process.

[0120] In a fifth aspect of the invention, a concept for an improved seal for a drug delivery device is described, wherein the improved seal is located at the interface between a rigid sleeve, which is a portion of the needle assembly's input section, and a flexible sleeve, which is a portion of the needle assembly's output section. The flexible sleeve input seal design ensures impermeability at occlusion pressures, facilitates easy assembly, and enhances the device's lifespan and robustness.

[0121] This objective is achieved by a drug delivery device comprising: a housing having a reservoir located inside the housing to contain a drug; a needle assembly having an input portion and an output portion; wherein the needle assembly includes a soft cannula having an open distal end, and a rigid cannula at least partially and slidably disposed within the soft cannula cavity of the soft cannula; the proximal input end of the rigid cannula is part of the input portion of the needle assembly, and the distal output end of the soft cannula is part of the output portion of the needle assembly; wherein the proximal input end of the soft cannula forms a sliding soft cannula input seal configured to slide on the rigid cannula when a tightening pressure is applied to ensure an impermeable fluid seal at the occlusion pressure.

[0122] In a sixth aspect of the invention, a concept for an improved seal for a drug delivery device is described, wherein the improved seal is located at the interface between the housing and the output portion of the needle assembly. The improved outlet port seal ensures the impermeability of the housing to ambient pressure, reduces the number of components in the drug delivery device, facilitates easy assembly, saves costs, and enhances the device's lifespan and robustness.

[0123] This objective is achieved through a drug delivery device comprising: a housing with a covering surface separating an internal volume from an external volume; a reservoir located inside the housing to contain a drug; a needle assembly with an inlet and an outlet portion; and an outlet port assembly, wherein the housing includes at least two members configured to attach to each other to form a protective shell of the drug delivery device; the reservoir includes a reservoir outlet coupled to the inlet portion of the needle assembly; the housing includes an outlet port opening to provide a passage from the interior to the exterior of the output portion of the needle assembly; and the outlet port assembly is configured to form an opaque space between the housing and the output portion of the needle assembly. Fluid connection; the outlet port assembly includes a rigid outlet port seal retainer and a soft outlet port seal, the rigid outlet port seal retainer having at least a partially tubular outlet port channel defining an axis of the outlet port channel, configured to receive the output portion of the needle assembly, the soft outlet port seal being attached to the rigid outlet port seal retainer during the manufacture of the drug delivery device; the soft outlet port seal being configured to be pierced by the output portion of the needle assembly during the manufacture of the drug delivery device; and thus the soft outlet port seal being further configured to provide an impermeable fluid closure of the outlet port opening of the housing when the outlet port assembly is mounted on the housing.

[0124] The following paragraphs explicitly describe three exemplary approaches to realizing this concept.

[0125] An outlet port seal design according to the concept described is achieved by manufacturing the outlet port assembly as a monolithic component through a two-stage injection molding process, the monolithic component comprising a rigid outlet port seal retainer and a soft outlet port seal.

[0126] Another outlet port sealing design according to the concept described is achieved by connecting the outlet port assembly to one of at least two housing members and manufacturing the outlet port assembly as a monolithic component through two injection molding processes. This monolithic component includes at least one of the at least two housing members, a rigid outlet port seal retainer, and a soft outlet port seal. By including the housing portion, this multifunctional component can specifically include other seals for the housing, such as a seal at the mechanical interface between the reservoir unit and the pump unit of a semi-disposable patch pump.

[0127] According to another outlet port sealing design based on the concept described, this is achieved by adapting a rigid outlet port seal holder to further include an outlet port sealing cavity defining the axis of the outlet port sealing cavity, and opening at at least one end to receive a soft outlet port seal; the outlet port sealing cavity is arranged to intersect the outlet port channel at an angle of at least 10 degrees, preferably at least 45 degrees, between the axis of the outlet port channel and the axis of the outlet port sealing cavity; the axis of the outlet port sealing cavity and the axis of the outlet port channel intersect at an angle of at least 10 degrees, preferably at least 45 degrees; during the manufacture of the drug delivery device, the soft outlet port seal is inserted into the outlet port sealing cavity; and the soft outlet port seal is configured to tightly close the outlet port sealing cavity and the outlet port opening when installed in the rigid outlet port seal holder.

[0128] Another advantageous feature of the outlet port seal design according to the described concept is achieved by modifying the outlet port seal plug cavity to include contraction and / or flattening at the outlet port opening, thereby improving the compression and / or shaping of the soft outlet port seal at the intersection with the outlet port channel. Increased compression results in impermeability at higher pressures, while the flat shape of the outlet port seal makes it easier to puncture during manufacturing.

[0129] Another advantageous feature of the outlet port sealing design according to the concept described is achieved by modifying the shape of the housing in one of the previously described devices and by introducing a recess from the covering surface of the housing at the outlet port opening. With the outlet port located in the recess, the patch pump can be manufactured ready for use with the output portion of the needle assembly already passing through the outlet port, providing sufficient sealing and ease of use without any part protruding from the covering surface of the housing. Furthermore, the recess in the housing forms an external outlet port chamber between the recessed outlet port opening and the covering surface of the housing, which allows the reservoir and fluid path to be filled before use without the risk of injecting any medication into the patient's body. By filling the fluid path with medication before inserting the cannula into the patient's body and before initiating drug delivery, the pump avoids infusing air instead of medication at the start of the infusion process and improves the accuracy of drug delivery.

[0130] Regardless of the implementation approach, the features of the outlet port sealing design according to the concept described are particularly advantageous for semi-disposable patch pumps with needle assemblies, wherein the needle assembly includes: a flexible sleeve having an open distal end; a rigid sleeve at least partially and slidably disposed within the inner cavity of the flexible sleeve; and a needle insertion mechanism configured to bring the output portion of the needle assembly, at least with the open distal end of the flexible sleeve, from a first position inside the outlet port chamber to a second position outside the housing on the outlet port exterior. Such an insertion mechanism significantly improves ease of use.

[0131] In a seventh aspect of the invention, a concept for an improved seal for a patch pump is described, which is located in the area of ​​the outlet port at the interface between the housing and the environment before the pump is applied to a patient's body. The outlet port cap design ensures impermeability at the minimum filling pressure specified for use with the patch pump, supports the filling and pre-filling process, and facilitates easy assembly and use of the device.

[0132] This objective is achieved by a drug delivery device (e.g., a device described in previous aspects of the invention) having an outlet port and an outlet port cover located in a recess of the housing, wherein the outlet port cover is removably attached to the housing at a portion surrounding the outlet port opening; the outlet port cover covers the outlet port chamber in such a way that it prevents fluid from entering or leaving the outlet port chamber while allowing air to pass through; the outlet port cover comprises a membrane of any semi-permeable material adapted to allow air to pass through while preventing liquid from passing through; the outlet port cover includes a membrane reinforcement structure permanently fixed to the membrane to ensure that the membrane is not damaged during removal of the outlet port cover from the housing. Such a membrane reinforcement structure may be a plastic sheet with slits for the outlet port opening.

[0133] In an eighth aspect of the invention, a concept for an improved seal for a patch pump is described, which, after the pump is attached to a patient's body, is located at the interface between the housing and the environment in the area of ​​the outlet port. The design of the housing and the adhesive patch assembly improves the reliability and stability of drug delivery, while also providing easier and more comfortable use of the patch pump.

[0134] This objective is achieved by a drug delivery device as previously described and used as a patch pump, the patch pump having an adhesive patch assembly for attaching the pump to a patient, wherein the adhesive patch assembly includes an adhesive layer configured to attach the adhesive patch assembly to the patient after the patch pump is ready for drug delivery; the adhesive patch assembly includes a removable adhesive release liner to protect the adhesive layer from accidental adhesion prior to use, particularly during patch pump preparation for drug delivery; an outlet port cap is permanently fixed to the adhesive release liner and removably attached to the housing; and the outlet port cap is configured to be removed from the housing together with the adhesive release liner during patch pump preparation for drug delivery.

[0135] The design of the housing and adhesive patch assembly in the outlet port region is particularly advantageous for patch pumps as previously described, wherein the housing further includes a membrane support structure arranged around the outlet port chamber; the membrane support structure is adapted to protrude from the housing toward the outside to a height substantially the same as the thickness of the adhesive patch assembly; the membrane support structure is configured to provide contact with the outlet port cap in a state in which the outlet port cap is removably attached to the housing; the membrane support structure is configured to provide an impermeable fluid connection between the outlet port cap and the housing during patch pump preparation for drug delivery, and thereby tightly close the outlet port chamber.

[0136] While reliable attachment of the adhesive patch assembly to the patient's body (particularly in the outlet port area) is important for reliable drug delivery, further improvements to the patch pump design at the interface between the housing and the environment in the outlet port area involve introducing numerous venting channels at a distance from the outlet port. These allow air and / or moisture to leave the interface and improve the adhesion of the patch pump to the patient's body during drug delivery. This is achieved using a patch pump as previously described, whereby the housing and / or adhesive patch assembly further includes at least one ventilation structure with at least one closed inner end disposed at a horizontal distance of 1 mm to 20 mm, preferably 5 mm to 10 mm, from the outlet port chamber, and at least one open outer end disposed at the peripheral edge of the housing and / or adhesive patch. The horizontal distance of the venting channels from the outlet port chamber is important for maintaining a tight closure around the outlet port and for preventing connection between the ventilation structure and the outlet port chamber. The ventilation structure is configured to allow air to pass from the inner end through the outer end and to the environment of the patch pump. During drug delivery, the ventilation channel formed by the ventilation structure can be on the surface of the patient's body (if the ventilation structure is implemented in the adhesive patch assembly) or further toward the housing (if the ventilation structure is formed by the housing or by another layer of the adhesive patch assembly).

[0137] In a ninth aspect of the invention, a ventilation assembly for improved pressure compensation of a patch pump is described, the ventilation assembly being located at the interface between the interior of the housing and the external environment. The design of the ventilation assembly according to the invention includes the design of the housing and the design of the adhesive patch assembly. The ventilation assembly according to the invention improves the reliability and robustness of drug delivery while also providing a safer and more comfortable use of the patch pump.

[0138] According to the present invention, these objectives are achieved by a ventilation assembly for a storage unit of a wearable drug delivery device, the ventilation assembly comprising: a storage unit housing defining an internal volume separate from the outside, the storage unit housing including a bottom wall forming a substrate on the bottom of the storage unit housing; an adhesive patch assembly including an adhesive layer and a release liner; an adhesive mounting strip securing the top side of the adhesive layer to the substrate, wherein the bottom wall forms a recessed surface in the substrate, creating a cavity between the recessed surface and the top side of the adhesive layer, and the bottom wall forms one or more through-holes fluidly connecting the cavity to the internal volume of the storage unit housing. The ventilation assembly further comprises: a waterproof and breathable pressure compensation membrane hermetically attached to the bottom wall, wherein all of the one or more through-holes are covered by the pressure compensation membrane, and wherein the cavity opens to an opening to the outside, the opening being edged by the recessed surface and the top side of the adhesive layer, and wherein the cavity contains a permeable spacer structure. Due to its rigid yet permeable form, the permeable spacer structure prevents the adhesive layer from closing the pressure compensation membrane nearby. Therefore, good ventilation and pressure balance are ensured even when the use of patch pump 1 causes the adhesive layer to bulge inward. This is possible if the target tissue is moved, or if the patch pump is exposed to external forces (e.g., a user lying on the pump or wearing tight clothing). Or in other words, the adhesive layer is restrained from further inward bulging, i.e., touching the membrane, as it reaches the rigid spacer structure.

[0139] Furthermore, the ventilation assembly for a drug delivery device reservoir unit according to the invention may include a spacer structure comprising corrugated, raised, or pleated sheets, strips, or meshes formed of metal or rigid plastic. In such an arrangement, ambient air can easily reach the surface of the pressure-compensating membrane, and the surface or perforations of the membrane are protected from being covered by an adhesive layer.

[0140] Furthermore, the ventilation assembly for a drug delivery device reservoir unit according to the invention may include a spacer structure comprising a permeable cylindrical element having a uniform surface and made of a porous or perforated material. In such an arrangement, ambient air can easily reach the surface of the pressure-compensating membrane, and the surface or pores of the membrane are protected from being covered by an adhesive layer.

[0141] Furthermore, the ventilation assembly for a drug delivery device reservoir unit according to the invention may include a spacer structure having one or more cuts and / or protrusions and / or recesses and / or punctures. In such an arrangement, ambient air can easily reach the surface of the pressure-compensating membrane, and the surface of the membrane or its perforations is protected from being covered by an adhesive layer.

[0142] Furthermore, the ventilation assembly for a drug delivery device storage unit according to the invention may include a spacer structure that occupies at least the space in the cavity (211q), wherein one or more through holes penetrate the bottom wall. This arrangement saves space.

[0143] Furthermore, the ventilation assembly for a drug delivery device reservoir unit according to the invention may include a pressure-compensating membrane placed on the outer side of the bottom wall within the cavity. This alternative arrangement saves space.

[0144] Furthermore, the ventilation assembly for a drug delivery device reservoir unit according to the invention may include a pressure-compensating membrane disposed on the inner side of the bottom wall within the internal volume of the reservoir unit housing. This arrangement further protects the membrane.

[0145] Furthermore, the ventilation assembly for a drug delivery device reservoir unit according to the invention may include a pressure-compensating membrane directly welded or glued to a corresponding side of the bottom wall. This ensures the attachment is leak-proof.

[0146] Furthermore, the ventilation assembly for a drug delivery device reservoir unit according to the invention may include a pressure-compensating membrane attached to a corresponding side of the bottom wall via an annular membrane bonding patch. This ensures leak-proof adhesion, facilitates assembly, and improves membrane ventilation.

[0147] Furthermore, the ventilation assembly for a drug delivery device reservoir unit according to the invention may include a pressure-compensating membrane made of a fabric of expanded PTFE (ePTFE), which is a stretched form of the PFAS compound polytetrafluoroethylene (PTFE). Such fabrics ensure gas permeability while maintaining water resistance.

[0148] Furthermore, the ventilation assembly for the storage unit of the drug delivery device according to the invention may include a pressure-compensating membrane made of a fleece fabric of PET, polyester, or polypropylene. This ensures gas permeability while maintaining water resistance, and is free of perfluorinated and polyfluoroalkyl substances (PFAS).

[0149] Furthermore, the ventilation assembly for the storage unit of the drug delivery device according to the invention may include a pressure compensation membrane made of expanded polyethylene, which is a sustainable and harmless single-substance alternative to perfluorinated and polyfluoroalkyl substances (PFAS).

[0150] Furthermore, the ventilation assembly for a drug delivery device reservoir unit according to the present invention may include a spacer structure formed by or attached to the substrate (211a). This facilitates the assembly process and improves reliability in use.

[0151] Furthermore, the ventilation assembly for a drug delivery device reservoir unit according to the invention may include a spacer structure formed by or attached to an adhesive patch assembly. This simplifies the assembly process and improves reliability in use.

[0152] Furthermore, the ventilation assembly for a drug delivery device reservoir unit according to the invention may include a cavity fluidly connected to or integrated into a passage suitable for receiving a filling port assembly. This arrangement saves space.

[0153] In a tenth aspect of the invention, a bearing assembly for improving operational stability of a patch pump is described. This bearing assembly is used in the drive mechanism of a pump unit and includes a bearing element at the interface between the threaded rod and the base sleeve, the bearing element providing a bearing point to a bearing surface. Abnormal conditions of the pump (such as reservoir blockage) can be inferred from inappropriate variations in motor parameters (such as power, current, or induction). Variations in axial load are converted by the drive mechanism and occur with corresponding torque variations on the motor side of the drive mechanism. Friction within the drive mechanism results in additional torque. The frictional force generated due to the axial support of the threaded rod is highly dependent on the axial load itself, and its variation is superimposed on the variation in axial load, obscuring the inference of pump abnormal conditions. The object of the invention is to increase the signal-to-noise ratio of the measured values ​​of the motor parameters and to improve the inference of pump abnormal conditions therefrom.

[0154] According to the invention, this objective is achieved by a bearing assembly for a pump unit of a drug delivery device, the bearing assembly comprising: a hollow plunger rod having a proximal end and a distal end, defining a central longitudinal axis, and having internal threads; a threaded rod rotatable about the central longitudinal axis, having external threads, and forming a pivot in its proximal end section, the external threads configured to engage the internal threads of the plunger rod; a drive sleeve rotatably fixed to the threaded rod; a base sleeve having an end wall on its proximal side; and a bearing element wherein the base sleeve forms a mounting hole in its proximal end wall about the central longitudinal axis to axially receive the bearing element and the pivot, wherein the bearing element is arranged proximally adjacent to the pivot in the mounting hole, wherein the bearing element supports forces in the proximal direction of the threaded rod during delivery operations while driving the plunger rod in the distal direction, and wherein the bearing element axially holds the rotating threaded rod in place relative to the base sleeve.

[0155] Furthermore, the bearing assembly for a pump unit of a drug delivery device according to the present invention may include a mounting hole formed as a blind hole in the distal side of the end wall, or a through hole with an inner annular protruding edge or flange formed in the proximal section of the mounting hole. This facilitates the assembly process of the bearing assembly and improves the placement accuracy of the bearing elements.

[0156] Furthermore, the bearing assembly for a pump unit of a drug delivery device according to the invention may include a mounting hole, wherein the distal section of the mounting hole and the pivot form a planar bearing. Such a threaded rod and drive sleeve are precisely guided axially and remain capable of rotation about a central longitudinal axis. The effect of the planar bearing is to hold the bearing point between the bearing element and the pivot on the central longitudinal axis.

[0157] Furthermore, the bearing assembly for a pump unit of a drug delivery device according to the invention may include a bearing element with a convex surface on its distal side. The convex surface is rotationally symmetrical about a central longitudinal axis. Such a single bearing point may be formed between the convex surface of the bearing element and the surface of the pivot.

[0158] Furthermore, the bearing assembly for a pump unit of a drug delivery device according to the invention may include spherical bearing elements. This allows for easy assembly regardless of orientation and allows for cost-effective off-the-shelf sourcing of bearing elements.

[0159] Furthermore, the bearing assembly for a pump unit of a drug delivery device according to the present invention may include bearing elements made of metal or ceramic compounds. This ensures extended service life and consistently low frictional losses.

[0160] Furthermore, the bearing assembly for the pump unit of the drug delivery device according to the invention may include bearing elements made of medium alloy cold work steel (e.g., roller bearing steel, such as material 1.3505 / 100Cr6). This ensures extended service life and consistently low frictional losses, and ensures cost-effective off-the-shelf sourcing of bearing elements.

[0161] Furthermore, the bearing assembly for a pump unit of a drug delivery device according to the invention may include a threaded rod made of a metal alloy (e.g., steel 1.4305 / X8CrNiS18-9 or brass or bronze). In addition to the good machinability of this material, together with the material of the bearing elements, a friction pair with excellent frictional values ​​is produced.

[0162] Furthermore, the bearing assembly for a pump unit of a drug delivery device according to the invention may comprise a base sleeve made of glass fiber reinforced polyamide (e.g., GRILAMIDLV-50HFWA) or a polymer blend comprising polycarbonate (PC) and acrylonitrile / butadiene / styrene (ABS). This provides improved stiffness and good dimensional stability with temperature variations.

[0163] Furthermore, the bearing assembly for a pump unit of a drug delivery device according to the invention may include a pivot, wherein the proximal end face of the pivot forms a flat, convex, or concave bearing surface to contact a bearing point on the distal side of a bearing element at the central longitudinal axis. This provides extended service life and consistently low frictional losses, and stabilizes the bearing point on the central longitudinal axis.

[0164] Furthermore, the bearing assembly for a pump unit of a drug delivery device according to the invention may include an inner cavity or chamber defined by bearing elements in a mounting hole, and the bearing surface of the pivot contains a lubricating substance, such as a silica-thickened synthetic hydrocarbon grease, for example, NYOGEL 774. This provides extended service life and consistently low frictional losses, and prevents corrosion.

[0165] Furthermore, the bearing assembly for a pump unit of a drug delivery device according to the invention may include a drive sleeve having a drive pinion formed on its outer surface to introduce drive torque relative to a central longitudinal axis. This allows for a space-saving kinematic arrangement.

[0166] Furthermore, the bearing assembly for a pump unit of a drug delivery device according to the invention may include a cover configured to close the distal side of the base sleeve and configured to guide the plunger rod along a longitudinal axis. The cover, together with the plunger rod, may be configured for linear guidance of the plunger rod along and around the central longitudinal axis, or a combination of linear and rotational guidance.

[0167] Furthermore, the bearing assembly for a pump unit of a drug delivery device according to the invention may include a ball gear housed between a cap and a drive sleeve. The axis of rotation of the ball gear is on a central longitudinal axis. This arrangement allows the drive sleeve to be held and stabilized coaxially about the longitudinal axis at its distal end, and provides low frictional loss for rotation of the drive sleeve and the threaded sleeve. Together with a pivot at the proximal end guided by a planar bearing and bearing elements, improved accuracy and smoother operation of the drive sleeve and the threaded rod, as well as undisturbed thrust of the piston rod, are achieved.

[0168] Furthermore, a drug delivery device pump unit is within the scope of the present invention, the drug delivery device pump unit comprising a pump unit housing and / or a drive mechanism adapted to accommodate a bearing assembly according to the present invention. Attached Figure Description

[0169] The subject matter of the invention will be explained in more detail below with reference to preferred exemplary embodiments shown in the accompanying drawings, in which: Figure 1 A perspective view depicting the patch pump as seen from above (away from the patient, left side) and from below (towards the patient, right side); Figure 2a , 2b The mechanical interface between the pump unit and the storage unit; Figure 2a Describe the drive mechanism of the patch pump spanning two units; Figure 2b Describes the bayonet connection between the pump unit and the storage unit of the patch pump; Figure 3a , 3b This refers to the steps of attaching the pump unit to the storage unit of the patch pump; Figure 3a Depict a surface mount pump, wherein the pump module is connected to the memory module at a 30° angle via a bayonet; Figure 3b A cross-sectional view depicting the patch pump across the locking mechanism, with the locking mechanism closed (left: full cross-section, right: enlarged view of the locking mechanism); Figure 4 Depicts a patch pump that is attached to a patient's body and ready to deliver medication; Figure 5 Depicts the reservoir unit of the patch pump (front side without housing and adhesive release liner); Figure 6a , 6b A perspective view of a hybrid assembly with a sleeve moving component; Figure 6a Depict a perspective view of the hybrid assembly, with the sleeve moving assembly in its initial position; Figure 6b Depicting Figure 6a A hybrid component, but in which the sleeve moving component is in an extended position; Figure 7 Depicting Figure 6a , 6b A bottom view of the hybrid components; Figure 8a -c refers to the perspective view of the base frame; Figure 8a A perspective view depicting the base frame, including the non-conductive body and connector structure; Figure 8b A bottom-up perspective view depicting the non-conductive body of the base frame; Figure 8c Describe the connector structure of the base frame; Figure 9a , 9b A perspective view of a memory cell with a filled port after it has been fixed by thermal plugging; Figure 9a A perspective view depicting a storage cell partially assembled and inverted to show the filling port at the bottom of the cell; Figure 9b A cross-sectional view depicting a memory cell with a fixed fill port assembly and a memory inlet; Figure 10 Depicting as seen before the filling port is fixed by heat riveting, from Figure 9a , 9b A cross-sectional view of the memory cell; Figure 11 Depicting from Figure 9a , 9b A cross-sectional view of the storage unit (with an inserted fill port seal, but without an insert); Figure 12 Depicting from Figure 9a , 9b A cross-sectional view of the memory cell before the filling port assembly is installed; Figure 13 Depict the perspective view of the insert; Figure 14 The filled port seal is depicted in perspective (left) and cross-sectional view (right); Figure 15 A perspective view depicting a reservoir including a plunger; Figure 16 An exploded view of a storage cell is depicted, showing the cylinder and filling port assembly inserted into the storage cell housing to form the storage cell; Figure 17 Depict a perspective view of the pump unit, with the housing removed; Figure 18 A perspective view of the storage unit, with the casing removed; Figure 19 A patch pump with a reservoir outlet seal is depicted across a section spanning the reservoir outlet. Figure 20 A cross-sectional view depicting a patch pump with a flexible inlet seal; Figure 21a , 21b A schematic diagram of a patch pump with an outlet port; Figure 21a A patch pump depicting an outlet port in a flat area with a housing; Figure 21b A patch pump is depicted with an outlet port in the housing, wherein a recess is located at the outlet port; Figure 22a , 22b The export port component of the first preferred embodiment of the export port; Figure 22a A preferred embodiment of the outlet port assembly is depicted in perspective view (left) and cross-sectional view (right); Figure 22bDescribing across with Figure 22a A cross-sectional view of an embodiment of a fully assembled patch pump with outlet port components; Figure 23a -c indicates the export port component of the second preferred embodiment of the export port; Figure 23a A preferred embodiment of the outlet port assembly is depicted in a perspective view cut through the outlet port channel; Figure 23b A preferred embodiment of the cross-sectioned outlet port assembly is depicted (right side); Figure 23c Describing across with Figure 23a A cross-sectional view of an embodiment of a fully assembled patch pump with outlet port components; Figure 24a -d indicates the exit port component of the third preferred embodiment of the exit port; Figure 24a The housing component with an integrated rigid outlet port seal retainer is shown in a perspective view (left) from the outside and a cross-sectional view (right) across the outlet port before the soft outlet port seal is inserted. Figure 24b A cross-sectional view depicting the passage through the outlet port as seen from the middle side of the shell body, further illustrating the outlet port sealing plug cavity before assembly; Figure 24c A cross-sectional view depicting the passage through the outlet port as seen from the middle side of the shell, wherein a soft outlet port seal is installed in the outlet port sealing plug cavity; Figure 24d A cross-sectional view depicting the outlet port after the needle assembly pierces the seal; Figure 25a -e indicates the export port component of the fourth preferred embodiment of the export port; Figure 25a The housing component with an integrated rigid outlet port seal retainer is shown in a perspective view (left) from the outside and a cross-sectional view (right) across the outlet port before the soft outlet port seal is inserted. Figure 25b A cross-sectional view depicting the passage through the outlet port as seen from the middle side of the shell body, further illustrating the outlet port sealing plug cavity before assembly; Figure 25c A cross-sectional view depicting the passage through the outlet port as seen from the middle side of the shell, wherein a soft outlet port seal is installed in the outlet port sealing plug cavity; Figure 25d Depicting in Insertion Figure 25b The soft outlet port seals are placed before (left) and after (right) the outlet port sealing plug cavity; Figure 25eA cross-sectional view depicting the outlet port after the needle assembly pierces the seal; Figure 26a -c refers to an outlet port with an outlet port chamber and an outlet port cover; Figure 26a Depicts the outlet port cover of the closed outlet port chamber; Figure 26b An illustration of an outlet port cover in an embodiment with a membrane support structure; Figure 26c An exploded view depicting the adhesive assembly combined with the outlet port cover; Figure 27 Describe the ventilation recess at the bottom of the patch pump; Figure 28 A bottom-up perspective view depicting an embodiment of a patch pump including a ventilation assembly; Figure 29 A bottom-up perspective view of the patch pump, exposing the adhesive patch assembly on its underside; Figure 30 An exploded perspective view depicting an embodiment of the ventilation assembly; Figure 31 A bottom-up perspective view of the patch pump, exposing its bottom side, with the adhesive patch assembly removed; Figure 32a , 32b Refers to the base plate and bottom wall of the storage unit housing; Figure 32a Draw a bottom-up perspective view; Figure 32b Depicting Figure 32a Magnified details; Figure 33a , 33b Refers to the opening of the ventilation components; Figure 33a A side perspective view of patch pump 1 is depicted; Figure 33b Depicting Figure 33a Magnified details; Figure 34a , 34b Refers to the top view and sectional view of the pump unit, including the bearing assembly; Figure 34a Depict a top view of the pump unit; Figure 34b Depicting passing through, such as Figure 34a Enlarged sectional view AA of the pump unit specified in the diagram; Figure 35 Depicting a side perspective view of the pump unit; Figure 36 Depicting Figure 35 Rotating side perspective view of the pump unit; Figure 37 Depicts a side perspective view of the bearing assembly; Figure 38 A side perspective view of the bearing assembly is shown, with the base sleeve removed; Figure 39 Depict a cross-sectional perspective view of the base sleeve.

[0170] The reference numerals used in the accompanying drawings and their main meanings are listed in a summary form in the name list. In principle, the same parts are given the same reference numerals in the drawings. Detailed Implementation

[0171] As outlined in the introductory paragraph, the present invention has many aspects, all of which contribute to improving the overall optimal solution for a drug delivery device that is accurate, reliable, and easy to use, while still being suitable for complex therapies at the lowest possible cost. Although most preferred embodiments use... Figure 1 and Figure 2a , 2b The example of a wearable patch pump shown is used to illustrate this, but it is clear that the same aspects of the invention can also be used to improve any other kind of drug delivery device, provided that comparable features exist. Cost-effectiveness is achieved in particular by introducing new and improved methods for manufacturing and / or assembling drug delivery devices, as described below.

[0172] Figure 1 A perspective view depicting a preferred embodiment of the drug delivery device according to the present invention. The drug delivery device is implemented as a patch pump 1. The patch pump 1 includes a reusable pump unit 100 and a disposable reservoir unit 200. The reservoir unit 200 includes a reservoir for storing a drug and a needle assembly with a fluid path for carrying the drug from the reservoir into the patient's body. An adhesive patch assembly 280 is included at the bottom of the reservoir unit 200 to attach the patch pump 1 to the patient's body. The pump unit 100 is releasably and sealingly connected to the reservoir unit 200 via a bayonet connection. Figure 1 (Left side) Shows the complete patch pump 1, with two units connected, as seen from above. In the context of this invention, "above" or "top" refers to the side of the pump facing away from the patient's body when attached to the patient for drug delivery. Therefore, "bottom" or "base" refers to the side of the pump facing the patient's body during drug delivery. Figure 1 In the left image, arrow 114 indicates the direction toward the opening side of the patch pump 1, where the pump unit 100 is raised from the bottom of the storage unit 200. Figure 1 (Right side) A bottom view of the same pump 1, flipped up, and the adhesive patch assembly 280.

[0173] like Figure 2aAs shown, the pump unit 100 includes a drive mechanism for driving the plunger rod 122, an encoder for monitoring the movement of the drive mechanism, a rechargeable battery, and programmable electronic system control circuitry configured to control pump setup, drug delivery, and monitoring. When the drive mechanism is connected to the storage unit 200, the battery can be recharged using another battery in the disposable storage unit 200.

[0174] A drive mechanism 120 acts mechanically from a threaded rod 125 via a plunger rod 122 on a plunger 221 in a reservoir 222 to dispense medical material from the reservoir 222. A needle assembly 260 within the reservoir unit provides a fluid connection from the reservoir 222 to the outside of the pump for application to the patient. To ensure safe handling, the patch pump is manufactured, transported, stored, and prepared for use with the needle assembly 260, which is entirely within the cover shape of the pump 1. The cover shape is an imaginary surface that covers the housing of the pump 1 while smoothly bridging all gaps and recesses (if any) into a closed shell. The cover shape is the shape of the pump 1 as perceived by the user from a distance and is relevant when considering aspects of use, such as handling or wearability. Preparation of the patch pump in this embodiment includes: filling the reservoir within the reservoir unit 200 from the outside using a transfer syringe and attaching the pump to the patient's body by means of an adhesive patch assembly 280. The inserter assembly is included in the reservoir unit 200 and is configured to bring the output portion of the needle assembly 260 (particularly the open distal end of the needle assembly 260) out of the pump's envelope shape and into the patient's body once the pump is ready to begin drug delivery. In a preferred embodiment of the patch pump, the needle assembly 260 includes a rigid cannula and a soft cannula, and the inserter is configured to use the rigid cannula to insert the distal end of the soft cannula into the patient's body, the rigid cannula subsequently retracting for drug delivery.

[0175] The rechargeable battery provides power to the drive mechanism and system control circuitry. The latter controls the drive mechanism and can exchange data with external control devices, for example, via a wireless data connection. Furthermore, the rechargeable battery can provide power to the inserter assembly in the storage unit 200.

[0176] Figure 2b To display from the view above Figure 1 A semi-disposable patch pump in which the pump unit 100 and the storage unit 200 are disassembled and separated, wherein the adhesive patch assembly 280 at the bottom faces the patient's body and the bayonet connection 212a is in a disengaged state.

[0177] The first set of preferred embodiments illustrates a first aspect of the invention. They are based on what has been described previously. Figure 1 and Figure 2a , 2bThe wearable, semi-disposable patch pumps shown are described in detail in the following paragraphs.

[0178] The general objective of this invention is to provide a semi-disposable patch pump optimized for ease of use, cost-effectiveness, and minimal waste. (See below for details.) Figure 1 and Figure 2a , 2b As is evident from the general description of the embodiments, the patient assembly consists of only two components: a reusable pump unit 100 with all components intended for multiple or continuous use, and a disposable storage unit 200 with all components intended for single use. Figure 2b This illustrates a preferred embodiment of the semi-disposable patch pump according to the invention, wherein the pump unit 100 and the reservoir unit 200 are ready for application. The reservoir unit 200 is shown externally, having a reservoir unit housing 211 mounted on the adhesive patch assembly 280, and a mechanical interface with the pump unit, particularly the bayonet connection 212a shown on both units, the rotation axis 212b of the bayonet connection shown on both units, and a locking structure 212d integrated in the reservoir unit housing 211. The locking mechanism for the bayonet connection includes the locking structure 212d on the reservoir unit and a flexible locking spring 113a on the pump unit (see [link to original text]). Figure 3b The substrate 211a is integrated into the storage unit housing 211 and forms the bottom of the housing, at which the housing is attached to the adhesive patch assembly 280. Depending on the embodiment, the substrate may be a single integral component or a combination of components permanently joined together and attached to the adhesive patch assembly 280. The bayonet connection design includes the definition of an opening side 114 of the pump, which refers to the general direction or outside in which the pump unit is lifted from the substrate to open the connection and remove the pump unit. Figure 2b In the diagram, the substrate is shown with a substrate extension 212c on the opening side 114. When the pump unit 100 rotates about the rotation axis 212b of the bayonet, it is evident that the substrate extension 212c may only cover the area on the opening side of the pump starting from the rotation axis connected to the bayonet, because otherwise it would inhibit the connection of the pump unit to the storage unit.

[0179] A preferred embodiment of the storage unit is in Figure 16 and Figure 18 The diagram shows the selection section removed to reveal the internal components. Specifically, reservoir 222 shows a plunger 221 and a reservoir outlet 222c leading to a needle assembly 260 mounted on an inserter assembly 250, which provides an automatic insertion mechanism. In this embodiment, the reservoir axis 222e, along the axial center of reservoir 222 and plunger 221, is arranged to coincide with the rotation axis 212b of the bayonet connection. Figure 2bIn its fully assembled state, it is substantially orthogonal to the wall of the storage unit housing facing the pump unit.

[0180] A preferred embodiment of the pump unit is in Figure 2a , 2b and Figure 17 The diagram shows the internal components with the selection section removed. Specifically, the drive mechanism 120 shows a drive element (implemented as a threaded rod 125 mounted in and cooperating with the plunger rod 122), a rechargeable battery 150, and system control circuitry 140. In the fully assembled state, the threaded rod 125 and the plunger rod 122 are arranged in substantially the same direction as the rotation axis 212b connected to the bayonet, and are substantially orthogonal to the wall of the pump unit housing facing the storage unit.

[0181] To apply the patch pump 1 and begin drug delivery, the patient removes the reservoir 200 from its packaging. If the reservoir is not pre-filled with medication, the patient fills the reservoir 222 with medication. The pump unit 100 will typically be actuated due to prior use. If not, the patient may need to perform additional steps, such as unpacking, charging, or programming, to prepare the pump unit. External devices and / or system components, such as a remote control unit with wireless connectivity and software for interacting with the user and establishing communication with the pump unit, may be used. To attach the pump unit 100 to the reservoir unit 200, the user engages the bayonet connector 212a on the pump unit 100 with the bayonet connector 212a on the reservoir unit 200 at an opening angle along the bayonet rotation axis 212b. Depending on the design of the bayonet configuration, the opening angle is typically in the range of 5 degrees to 180 degrees, preferably 15 degrees to 45 degrees. The user pushes the two components together along the rotation axis of the bayonet connection 212a and folds the pump unit 100 downward onto the plane of the substrate 211a. In an example of a preferred embodiment, the plunger cap 123 at the end of the plunger rod 122 in the pump unit is connected to an opening behind the plunger 221 in the storage unit. With the bayonet components in place, the pump unit 100 folds downward onto the plane of the substrate 211a to close the connection. Figure 3a This step shows the pump unit at a 30-degree connection angle. The user ensures the bayonet connection is properly locked by pressing the pump unit 100 down onto the base plate 211a. By doing so, the flexible latch spring 113a of the pump unit can then engage with the locking structure 212d integrated into the housing of the disposable storage unit 200, locking the bayonet connection in the closed position. This state is... Figure 3b As shown in the figure. It is evident that the bayonet connection of the present invention may also include any other locking mechanism, such as a magnetic lock, Velcro, latch, or adhesive lock, provided that the lock can be released without introducing additional unlocking steps.

[0182] exist Figure 4 In this process, patch pump 1 is applied to the body of patient 300 and is ready for drug delivery. The covering surface or external shape of patch pump 1 is substantially edgeless and suitable for wearing, with minimal risk of the device being brushed off when slid over an edge such as a door frame.

[0183] After successful drug delivery within the reservoir, the patient removes the pump from his or her body. A single mechanical step is required to remove the pump unit from the used reservoir unit and prepare it for a new reservoir unit. The bayonet connection is opened by simply lifting the pump unit 100 from the plane of the base plate 211a at the pump's open side 114. The same movement unlocks the locking mechanism and opens the bayonet. To further facilitate this step, a cut 211m can be made on the pump 1's open side 114, on the base plate 211a or the base plate extension 212c. The cut 211m reduces the size of the base plate 211a at the location where the patient's fingers grip the pump unit 100 for unlocking and removing the reservoir unit 100. The cut can have any shape along the edge of the base plate 211a, preferably elongated, approximately as long as the width of a finger, and wide enough to create a tactile effect. Therefore, the size of the cut 211m along the substrate 211a and / or substrate extension 212c will typically be: 5 mm to 30 mm in length along the edge, and 1 mm to 10 mm in width away from the original edge of the substrate 211a and / or substrate extension 212c. Figure 3a The image shows an example of a cut at the edge of the substrate extension 211a. When folded upwards to the opening angle of the bayonet connection, the pump unit can be separated from the storage unit and attached to a new storage unit to continue the therapy.

[0184] Another set of preferred embodiments illustrates a second aspect of the invention. They are based on what has been described previously. Figure 1 and Figure 2a , 2b The wearable, semi-disposable patch pumps shown are described in detail in the following paragraphs.

[0185] Figure 5 , 6a Image 7 (from bottom to top) shows the storage unit 200, with a selected portion removed to allow observation of the inside of the storage unit 200. The storage unit 200 includes a storage unit housing 211, a reservoir 222 containing medical materials, a hybrid component 240 according to the invention, a button battery 244, and an adhesive patch (not shown) for attaching the patch pump 1 to the user's skin.

[0186] Figure 6a , 6bFigure 7 depicts a hybrid component 240, which is arranged inside the storage unit housing 211 of the storage unit 200, as shown in Figure 7. Figure 5 As shown in the image. The hybrid assembly 240 includes a portion of the inserter assembly 250, particularly the sleeve movement assembly 251. Figure 6a Hybrid assembly 240 is depicted, wherein cannula movement assembly 251 is in a biased initial position. Insertor assembly 250 brings cannula movement assembly 251 from the biased initial position into an extended position for drug delivery. For example, this movement may be achieved by an elastic element (like insert spring 252) built into the inserter mechanism. Figure 7 The system drive, wherein at least one of the elastic elements is preloaded during the manufacture of the patch pump. Figure 6b A hybrid assembly is depicted in which the cannula moving assembly 251 is in an extended position for drug delivery. Figure 7 Showing a bottom view of the hybrid component 240.

[0187] like Figure 6a As shown, the hybrid assembly 240 additionally includes a printed circuit board PCB-RU243, a button battery 244, and a base frame 241 for supporting the hybrid assembly 240, PCB-RU243, and battery 244.

[0188] The structural features of the base frame 241 are described in detail below. The function of the hybrid component 240 is then described.

[0189] Figure 8a The base frame 241 is depicted separately. The base frame 241 includes a connector structure 270 with four connector parts 271a-271d, and a non-conductive body 290 made of plastic, which is injection molded around the connector structure 270.

[0190] In the first production step, connector components 271a-271d are stamped from metal sheets. At this stage, connector components 271a-271d are physically connected to each other via bridging elements (which are temporary connecting metal elements). In the second step, the connector components 271a-271d, stamped from metal sheets, are bent to form electrical contact areas and arms. In the third step, connector components 271a-271d are overmolded from non-conductive plastic to form a non-conductive body 290 around an embedded metal structure. In the fourth step, the bridging elements between connector components 271a-271d are eliminated by stamping to electrically decouple connector components 271a-271d from each other. Connector components 271a-271d are made of conductive metal. The injection-molded non-conductive body 290 is made of non-conductive plastic.

[0191] Each of the four connector components 271a-271d includes a contact arm 272. Figure 8c Each contact arm includes a curved section. (e.g.) Figure 8c As shown, the first free end of the contact arm 272 forms a first electrical contact area 272a.

[0192] The first connector component 271a, the second connector component 271b, and the third connector component 271c all include a second end of a contact arm 272 having a second electrical contact region 272b. The second electrical contact region 272b is suitable for electrical contact with a PCB-RU243 (see [link to PCB-RU243]) supported by a non-conductive body 290. Figure 8a , 6a 6b).

[0193] The first connector component 271a additionally includes Figure 8c The switching arm 273 and the first battery contact arm 274 are shown in the diagram. The switching arm 273 is integrated into the first connector component 271a and resiliently held relative to the rest of the connector component. The switching arm 273 includes a contact surface at its free end, which is adapted to contact the pump unit printed circuit board PCB-PU141 (see [reference]) when the pump unit 100 is connected to the storage unit 200. Figure 17 Electrical contact is established in the electrical contact area of ​​the coin cell 244. The first battery contact arm 274 includes a first battery contact area 274a at its free end, which is adapted to be connected to the positive terminal of the coin cell 244.

[0194] The fourth connector component 271d includes only a first electrical contact area 272a and a second battery contact arm 275. The second battery contact arm 275 includes a second battery contact area 275a at its free end, and the second battery contact area 275a is adapted to be connected to the negative terminal of the button battery 244.

[0195] See Figures 8a-8c The non-conductive body 290 is described in detail. The non-conductive body 290 includes a first opening 291 extending through it, through which a first electrical contact region 272a of a contact arm 272 can be contacted from the outside of the base frame 241. A second electrical contact region 272b is electrically connected to a memory cell printed circuit board (PCB-RU) 243 through a second opening 292 in the middle of the non-conductive body 290. A switching arm 273 also protrudes through the second opening 292. On the underside of the non-conductive body 290, a first battery contact arm 274 and a second battery contact arm 275 extend from the non-conductive body 290, such that the first battery contact arm 274 and the second battery contact arm 275 can contact the positive and negative terminals of the battery 244, respectively.

[0196] like Figure 8aAs depicted, a non-conductive body 290 is integrated to form a linear guide for a cannula movement assembly 251, which includes a soft cannula retainer 253 and a rigid cannula retainer 254 (see [reference]). Figure 6a , 6b 7). For example Figure 8a As depicted in -c, the linear guide includes an upper guide rail 295 and a lower guide rail 296. The upper guide rail 295 is adapted to guide the flexible sleeve retainer 253 and the rigid sleeve retainer 254, allowing the retainers to transfer between a retracted position and an extended position at the second ends of the guide rails 295 and 296. The lower guide rail 296 is adapted to guide a retraction control portion for retracting the rigid sleeve retainer 254, allowing the control portion to transfer linearly along the lower guide rail 296. An end stop surface 297 is disposed at the first ends of the guide rails 295 and 296, constraining the linear movement of the flexible sleeve retainer 253 and the rigid sleeve retainer 254 and defining the initial or retracted position of the retainers 253 and 254.

[0197] On the upper side, four retaining pins 293 are integrated into the non-conductive body 290. During assembly, the memory unit printed circuit board (RU-PCB) 243 is mounted on the four retaining pins 293 and secured by thermal riveting.

[0198] On the bottom side of the base frame 241, the non-conductive body 290 forms a battery opening 245. Figure 7 (As shown in the image), it is suitable for accommodating a button cell 244. A holding element 246 for retaining the battery 244 is arranged next to the battery opening 245. Figure 7 The retaining element 246 depicted is integrated into the non-conductive body 290. When the battery is inserted into the battery opening 245, the retaining element 246 resiliently deflects to facilitate battery insertion. Once insertion is complete and the battery is placed in the battery opening 245, the retaining element 246 resiliently moves backward, thus retaining the battery 244 in the battery opening 245.

[0199] Figure 8 shows the base frame 241 as a complete integral component. Figure 8a ), shown in view of the non-conductive body 290 without embedded conductive structures ( Figure 8b ), and shown in a view of the conductive structure as presented after manufacturing is complete ( Figure 8c ).like Figure 8b In the best visible part of the non-conductive body 290, a tapered bearing pin 294 is further integrated on the upper side of the non-conductive body 290. The bearing pin 294 is adapted to pivotally support the insertion trigger 256.

[0200] In the final assembled state, the complete hybrid component 240 is placed inside the storage unit housing 211 of the storage unit 200, such as... Figure 5 As shown in the diagram. If the pump unit 100 of the patch pump 1 is connected to the storage unit 200 via bayonet connection 212a, then the connection pin 142 of the pump unit 100 (see...) Figure 17 The first electrical contact area 272a of each of the contact arms 272 is pressed onto the contact arm 272. Thus, an electrical connection is established between the battery 244 of the storage unit 200 and the system control circuit 140 in the pump unit 100, and between the storage unit printed circuit board PCB-RU243 and the system control circuit 140 in the pump unit 100.

[0201] The rechargeable battery 150 in pump unit 100 can be charged by the coin cell battery 244 in storage unit 200 via an electrical connection between pump unit 100 and storage unit 200. The system control circuit 140 can control the heating element of the heater assembly on PCB-RU243 via an electrical connection between PCB-RU243 and PCB-PU141 in pump unit 100. Similarly, the system control circuit can control other components on PCB-RU243 and / or acquire and process information about the state of the storage unit, such as the position of the needle assembly.

[0202] If the control circuit 140 of pump unit 100 sends a release command to PCB-RU243 in the storage unit, the heating element of the heater assembly is actuated. The heating element may then heat the fuse to melt, extend, or break. This may trigger the release of bias insert trigger 256, which is pivotally supported by bearing pin 294 (see [link]). Figure 6a and 6b After the bias insertion trigger 256 is released, it can rotate away from the soft sleeve retainer 253 and the rigid sleeve retainer 254, and thus release them. Following the release of the retainers 253 and 254, they are moved to an extended position by the actuation of the spring 252 guided by guide rails 295 and 296, thereby inserting the soft and rigid sleeves into the user's skin. The insertion mechanism is described in detail in European patent application EP18199475.7, which is hereby incorporated in its entirety.

[0203] Another set of preferred embodiments illustrates a third aspect of the invention. They are based on what has been described previously. Figure 1 and Figure 2a , 2b The wearable, semi-disposable patch pumps shown are described in detail in the following paragraphs.

[0204] Figure 9aA three-dimensional overview view of a storage unit 200 is shown inverted. The storage unit 200 includes a storage container or cylinder 222 and a filling port assembly 230, in this example, the filling port is located at the bottom. The storage unit 200 includes a housing 211 formed by a bottom wall 211g, side walls 211h, and a top wall 211i. The walls of the housing define an internal space having openings for receiving the storage container 222 (among other things). The filling port assembly 230 is preferably located in the bottom wall 211g, but may also be located in other wall sections. The filling port assembly 230 is used to fill an empty storage container 222, which is closed by a plunger 221. See [reference needed] Figure 9b Details of the infill port assembly 230, housing, and storage unit 222 are presented in the following cross-sectional view: - Figure 9b The assembled and fixed filling port assembly 230 in the middle, - Figure 10 The assembled but not yet fixed filler port assembly 230, - Figure 11 The partially assembled filler port assembly without insert 235, and - Figure 12 The components of the casing and storage unit.

[0205] like Figure 16 Exploded view and Figure 12 As best visible in the cross-sectional view, housing 211, preferably, has a bottom wall 211g including a passage 211c adapted to receive a fill port assembly 230 formed by insert 235 and fill port seal 231. The passage 211c in the wall of the housing is surrounded by recesses or recessed sections (211d, 211f), and the passage 211c is aligned with the inlet 222a of reservoir 222 to form an opening for receiving the fill port assembly. The bottom wall of housing 211, preferably, includes at least one retaining pin 211e, which is preferably made of the same thermoplastic polymer as the housing.

[0206] To properly position and secure the reservoir within the housing of the drug delivery device, a stabilizing protrusion 222b is integrated into the reservoir. When the reservoir is inserted into the housing of the drug delivery device, the stabilizing protrusion 222b slides into a recess in the inner wall of the housing. Figure 12 In this design, the recess is shown as a stabilizing recess 211k. With the stabilizing protrusion positioned within the stabilizing recess 211k, the reservoir is properly positioned and laterally secured to allow lateral pressure for mounting the filling port assembly. Furthermore, the interaction between the stabilizing protrusion and the stabilizing recess can be designed as a snap-fit ​​connector. Figure 12 and Figure 16 (Not shown in the image).

[0207] Once the reservoir 222 is inserted and guided into the housing 211, preferably until the reservoir abuts a stop in the housing, the inlet 222a of the reservoir is aligned with the passage 211c in the housing. The stop in the housing may be formed by a protrusion or projection on the housing portion adjacent to the reservoir.

[0208] To establish a fluid path from the outside to the reservoir inlet 222a and to ensure impermeability at specified pressures (such as filling pressure), the filling port assembly includes at least one seal. Figure 16 In the embodiment shown, a fill port seal 231 is inserted into a passage 211c of the housing along a longitudinal axis formed by the inlet 222a of the reservoir. The longitudinal axis of the inlet 222a is preferably perpendicular to the longitudinal axis 222e of the reservoir. The fill port seal 231 includes a cylindrical section 231f that connects the flange 231a to the punctureable diaphragm 231c. Figure 14 When the fill port seal is inserted into passage 211c, the axis of the cylindrical section 231f is aligned with the axis of the inlet 222a of the reservoir. The flange 231a has a lateral dimension that fits tightly into the second recessed section 211d of the housing 211, while the piercing diaphragm 231c fits tightly into the inlet 222a of the reservoir. The flange 231a is disc-shaped with a tapered opening 231g for access to the opening 231b, which terminates in the piercing diaphragm 231c. The flange 231a fits into the disc-shaped second recessed section 211d in the housing. The cylindrical section 231f forms the opening 231b, which is adapted to receive the sleeve 235c of the insert 235 (see below). The inlet of the fill port seal 231, starting from the flange, is tapered and adapted to receive the tapered opening 235a of the insert 235 (see below). Figure 13 The longitudinal axis of the cone of the insert coincides with the longitudinal axis of the inlet of the reservoir. In this example, the fill port seal 231 is made of both an elastomer and a thermoplastic polymer. Alternatively, only an elastomer may be used. The outer surfaces of the flange 231a and the cylindrical section 231f are made of an elastomer, such that the flange can form a seal toward the housing, and the distal end of the cylindrical section 231f can form a seal with the inlet 222a of the reservoir 222. The tapered section of the fill port seal 231 is made of a thermoplastic polymer to provide mechanical strength to the fill port seal 231. The fill port seal 231 in Figure 14 The image shows the entire component. The filling port seal is inserted into the filling port seal cavity 222g of the reservoir 222 (in...). Figure 15 (as shown in the image). The filled port seal 231 is preferably made using a rigid thermoplastic 231d (like PBT) and a soft elastomer 231e (like polysiloxane liquid silicone (LSR) rubber) by two-component injection molding.

[0209] Figure 11 The image shows a cross-section of the filling port seal 231 inserted into the passage 211c in the bottom wall 211g of the housing. The distal surface of the flange 231a contacts the proximal surface of the second recessed section 211d of the housing (see [reference]). Figure 12 Optionally, the housing includes a protruding edge 211j of the flange 231a of the contact fill port seal 231. The distal end of the cylindrical section 231f of the fill port seal 231 ( Figure 14 It has internal dimensions higher than the inlet 222a of the storage device. Figure 12 The external dimensions of the reservoir cause the distal end to be radially compressed as it enters the reservoir, thus establishing a second seal 239 between the filling port seal and the reservoir inlet 222a. Figure 9b The second seal 239 is oriented radially perpendicular to the axis of the reservoir inlet. Optionally, the distal end of the cylindrical section and / or the puncture-resistant diaphragm 231c forms an axial seal with the surface of the reservoir inlet.

[0210] Figure 16 The exploded view shows how the filling port seal 231 and insert 235 are inserted into the passage 211c of the housing. Figure 10 Shows a cross-section of the filler port assembly in this state before fixing. Insert 235 is made of metal (stainless Cr-Ni steel, such as AISI 305) and includes a tapered opening 235a connecting the base 235b to the sleeve 235c (see also...). Figure 13 A tapered opening 235a fits into the cone of a fill port seal 231 formed of thermoplastic polymer 231d. A sleeve 235c fits into an opening 231b in the seal for guiding a needle toward a piercing diaphragm 231c. The base 235b of the insert includes a cut or opening 235d adapted to be received by at least one retaining pin 211e extending from the housing, and the external dimensions of the base fit into a first recessed section 211f of the housing in this respect. Figure 10 The insert 235 is fixed to the housing by heat riveting with the retaining pin 211e, therefore the retaining pin 211e is heated and deformed. Figure 9b During the fixation of the insert 235, the flange 231a of the filling port seal 231 is axially compressed between the base 235b of the insert and the bottom wall 211g of the housing. Optionally, the flange is locally compressed by a protruding edge 211j present in the second recessed section 211d in the housing. Figure 11Due to the compression of the flange, a first seal 238 is formed, which is axially displaced from the second seal 239. The first seal 238 and the second seal 239 are established by a fill port seal and bridge the gap between the inlet of the reservoir 222 and the housing 211, preventing leakage from the reservoir into the housing and to the outside. Figure 9b In addition, the first seal 238 and the second seal 239 prevent contamination from the outside into the drug delivery device or into the storage container.

[0211] When the insert is fixed to the housing, the lateral movement of the reservoir 222 relative to the housing can also be restricted, or even act as an impact absorber for the reservoir. The reservoir inlet 222a is connected to the housing via a fill port seal 231 and an insert 235, and the elastomeric material of the fill port seal 231 can act as a pad or shock absorber between the rigid reservoir and the rigid housing.

[0212] Figure 16 The image shows a method for assembling a drug delivery device or a portion thereof. A reservoir 222 is inserted into an opening in the housing along its longitudinal axis 222e. A plunger 221 may already be present in the reservoir. Figure 9b Alternatively, the reservoir can be inserted into the housing 211 after it has been placed inside the housing 211. Preferably, the walls of the reservoir are reinforced with a number of reinforcing ribs 222f, which are also adapted to facilitate the orientation and guidance of the reservoir within the housing 211 during assembly. The housing of the drug delivery device may further have a stop surface that ensures that the inlet 222a of the reservoir is aligned with the passage 211c of the housing 211 when abutted by the reservoir. The inner surface of the housing may have longitudinal ridges to properly guide the reservoir to its final position. In a subsequent step, the fill port seal 231 and the insert 235 are inserted into the passage 211c in the housing along an axis defined by the tapered opening 235a of the insert (or the tapered opening of the fill port seal). The axis defined by the tapered opening 235a is preferably the same as the axis defined by the inlet 222a of the reservoir when the reservoir is in its final position. During the insertion of the fill port seal, the distal end of the fill port seal enters the inlet 222a of the reservoir to establish a second seal 239. During the securing of the insert, a first seal 238 is preferably established by thermal riveting of the retaining pin 211e. The hybrid assembly 240 is also inserted into the housing before, during, or after the insertion of the reservoir.

[0213] Another set of preferred embodiments illustrates a fourth aspect of the invention. They are based on what has been described previously. Figure 1 and Figure 2a , 2b The wearable, semi-disposable patch pumps shown are described in detail in the following paragraphs.

[0214] The reservoir outlet seal is improved through a design that is particularly cost-effective in manufacturing. Such an advantageous design has been described with respect to a third aspect of the invention, wherein the reservoir outlet seal is combined with an improved filling port. Figure 18 This shows an additional method used to improve the reservoir outlet seal. Figure 1 The storage unit is shown, with part of the housing removed, followed by a more detailed cross-sectional view spanning the storage outlet. Figure 19 The reservoir 222 has a rigid structure forming the reservoir outlet 222c. In this example, the reservoir outlet has a substantially cylindrical reservoir outlet sealing cavity 222d. During manufacturing, an impermeable closure of the reservoir outlet sealing cavity 222d is established by inserting a substantially cylindrical reservoir outlet seal 223 made of a soft, impermeable but punctureable material (such as silicone or any kind of rubber). In a separate manufacturing step, the reservoir outlet seal 223 is punctured by the input portion of the needle assembly. In this current example, the input portion of the needle assembly is formed by the input portion of a rigid sleeve 258. The result is an impermeable connection between the reservoir outlet and the needle assembly. Unlike a membrane-like seal, the substantially cylindrical shape of the reservoir outlet seal and therefore the reservoir outlet sealing cavity provides considerably improved impermeability (up to 6 to 8 bar of specified filling pressure in this example). A wide range of variations of this embodiment are possible within the scope of the invention. The reservoir outlet seal cavity and the reservoir outlet seal may be only partially cylindrical or have entirely different shapes, while maintaining a sufficiently large contact area between the reservoir outlet seal cavity and the reservoir outlet seal to provide the desired impermeability. The manufacture of the reservoir outlet can be varied by changing the order of the manufacturing steps, for example by piercing the reservoir outlet seal before or after inserting it into the reservoir outlet seal cavity. Further variations are generated by improving the outlet port seal applied to the reservoir outlet. All the features described under the fourth aspect of the invention (e.g., reducing the number of components by applying a two-stage injection molding technique, or improving manufacturability by introducing an outlet port sealing plug cavity intersecting the outlet port opening) also result in variations of the embodiments described for the reservoir outlet.

[0215] Another set of preferred embodiments illustrates a fifth aspect of the invention. They are based on what has been described previously. Figure 1 and Figure 2a , 2b The wearable, semi-disposable patch pumps shown are described in detail in the following paragraphs.

[0216] exist Figure 18 middle, Figure 1The storage unit 200 is shown, with a portion of the housing removed, revealing in particular the rigid sleeve 258 and the soft sleeve 259, which are the main components of the needle assembly in this embodiment. Figure 20 A cross-sectional view of the needle assembly is shown at the interface between the rigid sleeve 258 and the flexible sleeve 259. The rigid sleeve 258 has a generally tubular shape and is configured to slide axially within the flexible sleeve cavity 259a of the flexible sleeve while maintaining a fluid-tight seal at the proximal inlet end of the flexible sleeve 259. To achieve fluid-tightness at a specified fill pressure of up to 6 to 8 bar, the flexible sleeve has a flexible sleeve inlet seal portion 259b, wherein the material of the flexible sleeve 259 is deformed, thickened, or otherwise altered to increase the pressure of the flexible sleeve on the surface of the rigid sleeve. The sleeve inlet seal portion 259b of the flexible sleeve 259 may be formed during the manufacture of the needle assembly or during a later manufacturing step of the pump by injection molding, by applying heat and / or mechanical pressure from the outside of the needle assembly, or by other means used to thicken and / or deform the flexible sleeve 259. While the most preferred location for the sleeve input seal portion 259b is near the input portion of the flexible sleeve 259, variations of this embodiment in which the flexible sleeve input seal portion 259b further extends toward the output end of the flexible sleeve 259 are possible. Further variations may include a flexible sleeve input seal that is separate from the flexible sleeve.

[0217] Another set of preferred embodiments illustrates a sixth aspect of the invention. They are based on what has been described previously. Figure 1 and Figure 2a , 2b The wearable, semi-disposable patch pumps shown are described in detail in the following paragraphs.

[0218] The exit port is improved by reducing the number of components at the interface by integrating one or more previously separate components into a single component. Figure 21aA schematic overview view of the concept for application at the outlet port of a drug delivery device is provided. The pump housing shows a first housing member 213 surrounding an outlet port opening 213a, and two other housing members 214 connected to the first housing member 213 via housing seals 215. The combination of housing members (both the pump unit and the reservoir unit) forms a protective housing when equipped with a filling port and / or an outlet port and / or other sealing elements suitable for the intended use and connected for said intended use, to protect the pump from mechanical damage, contamination, or other forms of environmental intrusion. An outlet port assembly 261, including a rigid outlet port seal retainer 262 and a soft outlet port seal 263, is mounted at the outlet port opening 213a of the housing. To support the manufacturing process of the patch pump, the rigid outlet port seal retainer 262 not only holds the soft outlet port seal 263 in place to close the outlet port opening 213a, but also acts as a mechanical guide for the process of piercing the soft outlet port seal 263 using the output portion 260b of the needle assembly 260. The rigid outlet port seal retainer 262 may have any shape suitable for this purpose. Examples of simple shapes include straight tubes, bends, cones, U-shaped grooves, or combinations thereof. At the puncture point where the output portion 260b of the needle assembly 260 first contacts the soft outlet port seal 263, the rigid outlet port seal retainer is tubular in shape, which defines at least a partially tubular outlet port channel 262a with an axis 262b.

[0219] Rigid outlet port seal retainer 262 is attached to one of the housing components, in Figure 21a In the middle, the first housing component 213. A soft outlet port seal 263 is installed at the outlet port opening 213a to close the outlet port opening without fluid leakage, while a rigid outlet port seal retainer 262 is attached to the housing (in Figure 21aIn this process, a fluid-impermeable seal is established between the first housing member 213. This has the advantage that the connection between any housing member and the rigid outlet port seal retainer 262 does not need to be fluid-impermeable at all. The fluid-impermeability requirement of the outlet port is entirely ensured by a soft outlet port seal, which can be designed to withstand specified pressures, such as ambient pressure, occlusion pressure, or filling pressure. The soft outlet port seal 263 is made of a soft and elastic material, such as an elastomer similar to silicone rubber, or any other fluid-impermeable material, which can be pierced by the output portion 260b of the needle assembly 260 and is sufficiently elastic to provide the surface pressure required for a fluid-impermeable seal at a specified fluid pressure. Other examples of such elastomers may be EPDM rubber, polydimethylsiloxane rubber PDMS (preferably in LSR form), or elastomeric polyurethane (PUR) or thermoplastic elastomer (TPE). During manufacturing, a soft outlet port seal 263 is attached to a rigid outlet port seal retainer 262 to form an impermeable fluid connection, for example, by double injection molding, by press fitting, or by any other means of securing the seal for its intended use. The manufacturing process of the patch pump in this embodiment includes the steps of attaching the rigid outlet port seal retainer to the housing, thereby closing the outlet port opening, and the step of piercing the soft outlet port seal by the output portion 260b of the needle assembly 260. When the output portion of the needle assembly is intended to be inserted into a patient's body for drug delivery, the output portion 260b will typically have a rigid and sharp end, such as the end of a sharp needle or a rigid cannula. The order of the manufacturing steps is independent of the function of the outlet port; therefore, piercing the outlet port seal 263 can occur before or after mounting the outlet port assembly 261 into the housing of the drug delivery device. When the soft outlet port seal has two sealing functions, the step of attaching the rigid outlet port seal retainer to the housing can be the same as the step of attaching the soft outlet port seal to the rigid outlet port seal retainer.

[0220] The result is a patch pump that is easy to manufacture and features an integrated outlet port seal that performs three sealing functions in one piece: sealing the housing to a rigid outlet port seal retainer, sealing the output portion of the needle assembly to a rigid outlet port seal retainer, and sealing the outlet port opening to prevent fluid leakage.

[0221] A further improvement to the outlet port concept of the present invention is achieved by modifying the shape of the housing of the drug delivery device and by introducing a recess in the region of the outlet port. This alternative solution... Figure 21b As shown in the schematic overview, Figure 21b Targeting and Figure 21aThe same markings are used for the same parts. A recess in the housing creates an outlet port chamber 213b, and the outlet port opening 213a is now located deep enough within the pump's covering surface 1a that the output portion 260b of the needle assembly 260 is completely contained within it. This arrangement has the advantage of protecting the output portion of the needle assembly from unintentional physical contact, contamination, or damage to the environment, while also protecting the user and / or patient from unintentional contact with the output portion of the needle assembly, thus reducing the risk of injury due to needlesticking.

[0222] The outlet port concept of the present invention leads to at least three main groups of further improved embodiments. In the first group, the outlet port is improved by combining the outlet port assembly, the rigid outlet port seal retainer, and the soft outlet port seal into a single integral component. Figure 22a , 22b A preferred embodiment of this group is shown. Figure 22a The outlet port assembly 261 is shown in perspective (left) and cross-section (right). The outlet port assembly 261 is manufactured as a single integral component, for example, by two-stage injection molding, wherein the rigid outlet port seal retainer 262 and the soft outlet port seal 263 are injected in separate injections using materials different from those defined by the previously described design. Alternatively, the outlet port assembly 261 can be pre-manufactured by attaching the two components, for example, by gluing, by applying a pressure fit, or by any other technique that results in a fluid-tight connection between the two components. Figure 22a In the present invention, the multiple sealing functions of the soft outlet port seal are well visible: the seal not only covers the open distal end of the outlet port channel 262a, but also includes a sealing area surrounding the outlet port channel to seal the interface with the housing and close the outlet port opening in the assembled state. Figure 22b The device is shown to be fully assembled and in use. Figure 22a The patch pump in an embodiment of the outlet port assembly includes a needle assembly 260 with an output portion 260b.

[0223] In a second set of embodiments according to the sixth aspect of the invention, the outlet port is improved by combining the outlet port assembly with one of the components of the housing into an integral component. Figure 23a -c indicates one of the many possible preferred embodiments of this group. Figure 23aThe first housing member 213 is shown in a perspective view cut along the axis of the outlet port channel, with all soft components attached. The first housing member 213 is manufactured as a single integral component, for example, by two injection molding processes utilizing both soft and hard materials. A rigid outlet port seal retainer 262 is an element of the first housing member 213, made of a rigid material, and manufactured, for example, in the first injection molding. For example, as previously described, a soft outlet port seal 263 is injected using a soft material in the second injection molding. The material can be selected to match the requirements of the drug delivery device, particularly its impermeability at the specified pressure for the outlet port. A particular advantage of this set of embodiments is that not only can the rigid outlet port seal retainer be integrated into the housing, but the soft outlet port seal can also be combined on the same housing member with other seals or functional elements requiring soft materials. Figure 23a and 23b In this design, the multiple sealing functions of the soft outlet port seal are readily apparent: the seal not only covers the open distal end of the outlet port channel 262a, but also includes a housing seal 215 designed for other purposes within a housing. The soft material channel can connect different sealing elements to improve manufacturability. Within the limits of manufacturability, any type of housing component integrating the outlet port assembly with other housing elements, as described in this invention, can be realized. Figure 23b yes Figure 23a The cross-section of the outlet port assembly is shown to reveal the shape of the soft outlet port seal 263, which closes the distal end of the outlet port channel 262a. Figure 23c The device is shown to be fully assembled and in use. Figure 23a The patch pump in an embodiment of the outlet port assembly includes a needle assembly 260 with an output portion 260b.

[0224] In a third set of embodiments according to the sixth aspect of the invention, the outlet port is improved by retaining the soft outlet port seal as an independent component and by improving manufacturability through the introduction of an outlet port sealing plug cavity configured to allow easy insertion of the soft outlet port seal. Using this approach, no additional component is required as a rigid outlet port seal retainer; therefore, the rigid outlet port seal retainer is integrated into the housing component.

[0225] Figure 24a -d indicates a preferred embodiment of this group. Figure 24aThe first housing member 213 is shown in perspective (left) and cross-section (right). The first housing member 213 is manufactured as a single integral component, for example by injection molding, and may also integrate other elements, such as the housing seal 215. A rigid outlet port seal retainer 262 is an element of the first housing member 213 made of a rigid material. A soft outlet port seal 263 is manufactured as a separate component, for example by injection molding using a different mold. In this set of embodiments, the element of the first housing member corresponding to the rigid outlet port seal retainer 262 has an outlet port sealing plug cavity 213c, which is at least partially tubular and intersects the outlet port channel 262a at a minimum angle between 10 degrees, most preferably 45 degrees and 90 degrees. Figure 24a All of this is illustrated by indicating the outlet port channel axis 262b and the outlet port sealing plug axis 213d. In this embodiment, the outlet port sealing plug 213c is open at its axial end. A soft outlet port seal can be easily inserted into the outlet port sealing plug 213c along the outlet port sealing plug axis 213d and provides a fluid-impermeable seal for the outlet port opening 213a. In this example, the outlet port seal has a substantially cylindrical shape, but may have any other shape suitable for easy insertion through the open surface of the outlet port sealing plug while closing the outlet port opening 213a in a fully assembled state. Two additional figures are added to further explain the shape of the outlet port sealing plug in this embodiment. Figure 24b This is a perspective view of the first housing member 213, wherein the rigid outlet port seal retainer 262 is sectioned along the outlet port channel axis to show the shape of the outlet port sealing plug cavity 213c. Figure 24c The same view is shown in the middle, but in which the soft outlet port seal is inserted into the rigid outlet port seal cavity. Figure 24a In the example of -d, both the outlet port sealing plug cavity 213c and the soft outlet port seal 263 are essentially cylindrical in shape with a section cut off. This shape is advantageous because the soft outlet port seal can be inserted into the rigid outlet port seal holder like a cylindrical plug, while the flat sides provide better retention during the piercing step. The minimal angle between the outlet port sealing plug cavity 213c and the axis of the outlet port channel facilitates the manufacturing step of piercing the outlet port seal using the output portion 260b of the needle assembly 260. Another advantage of the angle between the axis of the outlet port sealing plug cavity and the axis of the outlet port channel is that the soft outlet port seal is held in place by the rigid outlet port seal holder 262 when the output portion of the needle assembly pierces through it, resulting in small or no shear or tension forces at the connection between the soft outlet port seal and the rigid outlet port seal holder, further improving the seal to reliably meet the specified impermeability requirements.

[0226] Figure 24d The device is shown to be fully assembled and in use. Figure 24a The patch pump in the embodiment of the -c outlet port assembly includes a needle assembly 260 with an output portion 260b.

[0227] Figure 25a -e indicates the connection with Figure 24a Another set of preferred embodiments is similar to the set of embodiments in -d. Figure 25a The first housing member 213 is shown in perspective (left) and cross-section (right). As before, the first housing member 213 is manufactured as a single integral component, for example by injection molding, and may also integrate other elements, such as the housing seal 215. The rigid outlet port seal retainer 262 is an element of the first housing member 213 made of a rigid material. The soft outlet port seal 263 is manufactured as a separate component, for example by injection molding using a different mold. Still like Figure 24a Like the group in -d, the element of the first housing member corresponding to the rigid outlet port seal retainer 262 has an outlet port sealing plug cavity 213c (in Figure 25a The outlet port seal is filled with a soft outlet port seal 263. The outlet port seal cavity with the outlet port seal cavity axis 213d still intersects the outlet port channel 262a with the outlet port channel axis 262b at a minimum angle of 10 degrees, most preferably between 45 degrees and 90 degrees. However, in this set of embodiments, the outlet port seal is no longer a cylindrical plug, but can have any other shape suitable for being pressed into the outlet port seal cavity through at least one open side. In this set of embodiments, the outlet port seal cavity axis no longer implies rotational symmetry, but indicates the path along which the soft outlet port seal is inserted into the rigid outlet port seal retainer. Pushing a wide seal into the cavity a short distance (which can be seen as a lateral assembly of the plug) is significantly easier than pushing a cylindrical seal axially, and results in a significant improvement in manufacturability. An additional advantage of this set of embodiments is that the outlet port seal cavity can be designed in a wide variety of shapes, particularly by adding a contraction or flattening portion around the open distal end of the outlet port channel to increase compression and optimize the impermeability and punctureability of this area without compromising ease of assembly during manufacturing. For lateral insertion, the outlet port seal 263 is preferably irregularly shaped like a cylinder, but more like a gasket or plate, such as Figure 25d As shown on the left. Two more figures are added to further explain the shape of the outlet port sealing plug cavity in this set of embodiments. Figure 25b This is a perspective view of the first housing member 213, wherein the rigid outlet port seal retainer 262 is sectioned along the outlet port channel axis to show the shape of the outlet port sealing plug cavity 213c. Figure 25cThe same view is shown in the middle, but in which the soft outlet port seal is inserted into the rigid outlet port seal cavity. Figure 25d Show Inserted Figure 25b The soft outlet port seal 263 is located before (left) and after (right) the outlet port sealing plug cavity 262. It is readily apparent that, in the arrangement described, the soft outlet port seal 263 is elastically deformed by the insertion and compressed at a substantially orthogonal angle using a flat surface at the point where the output portion of the needle assembly will pierce the seal.

[0228] Figure 25e The device is shown to be fully assembled and in use. Figure 25a The patch pump in the embodiment of the -e outlet port assembly includes a needle assembly 260 with an output portion 260b.

[0229] Another set of preferred embodiments illustrates a seventh aspect of the invention. They are based on what has been described previously. Figure 1 and Figure 2a , 2b The wearable, semi-disposable patch pumps shown are described in detail in the following paragraphs.

[0230] like Figure 26a As shown in -c, the patch pump is further improved by covering the outlet port chamber 213b with a semi-permeable outlet port cap 285, which is removably attached to the patch pump housing 214. The outlet port cap 285 is configured to allow air to pass through while stopping and preventing any fluid (such as water or fluid medication) from entering or leaving the outlet port chamber 213b. With such an outlet port cap, the needle assembly 260 and the reservoir 222 can be filled with medication from the outside without any fluid coming into contact with the patient. During the filling of the reservoir 222 and / or the pre-filling of the fluid path through the needle assembly 260, the air initially present in the fluid path and / or the outlet port chamber is at least partially pushed over the outlet port cap and replaced by fluid. However, the fluid is stopped by the outlet port cap. This has two advantageous effects: first, as mentioned earlier, no medication spills through the outlet port when the outlet port cap is in place; second, the outlet port cap 285 closes the fluid path and ensures that filling pressure can be applied to the moving plunger 221 and the fluid required to fill the reservoir. By supporting the process of filling the reservoir and / or pre-filled fluid path, the outlet port cap of the present invention makes a significant contribution to the safe and reliable operation of the drug delivery device. The outlet port cap is implemented using a pre-filled membrane 285a (preferably in sheet form, such as GoreTex® or similar products) made of a semi-permeable material. Figure 26aAs shown in the basic embodiment, because such membranes are often mechanically weak, a membrane reinforcement structure 285b is preferably permanently fixed to the pre-charged membrane 285a in the region surrounding the outlet port chamber 213b. For example, the membrane reinforcement structure can be a plastic ring, mesh, net, or sheet of textile material, strong enough to allow removal of the outlet port cover without damaging it, and configured to allow fluid contact with the pre-charged membrane. The membrane reinforcement structure 285b can be removably attached to the housing member 214, for example, by means of adhesive or double-sided adhesive tape. The double-sided adhesive tape can even be the same as the membrane reinforcement structure 285b, having a first side permanently adhered to the pre-charged membrane 285a and a second side removably adhered to the housing member 214. The presence of the membrane reinforcement structure is important to allow the outlet port to be designed for impermeability at a specified minimum pressure (such as the filling pressure) while still ensuring easy handling of the pump.

[0231] In this basic embodiment, the outlet port cap 285 further includes an outlet port cap liner 285c permanently fixed to the membrane reinforcement structure 285b, but not attached to the housing member 214. Using the outlet port cap liner 286, the outlet port cap 285 can be easily removed from the housing 214 after successful filling and / or pre-filling of the patch pump. The concept of the outlet port cap can be advantageously applied to all types of drug delivery devices where filling and pre-filling are not functions unique to patch pumps.

[0232] For optimal accuracy and reliability, it is particularly important for patch pumps to maintain good adhesion of the area surrounding the output portion of the needle assembly to the patient's body during drug delivery (ideally utilizing an impermeable fluid connection). The outlet port concept with an outlet port cap is further improved by bringing the edge of the adhesive layer providing this impermeable fluid connection closer to the outlet port. This is achieved by integrating the outlet port cap into the adhesive patch assembly. Figure 26bA preferred example of such an embodiment is shown. The outlet port cover 285 still includes a pre-filled membrane 285a and a membrane reinforcement structure 285b. To bring the adhesive patch assembly 280 as close as possible to the boundary of the outlet port chamber 213b, a membrane support structure 212e is introduced. The membrane support structure is permanently attached to the housing member 214, preferably integrated therein as an element of the same integral component. The membrane support structure has substantially the same thickness as the adhesive patch assembly 280 and is shaped to surround the outlet port chamber such that an impermeable fluid connection is created between the housing 214 and the outlet port cover 285 as long as the outlet port cover 285 is attached to the housing. A very simple example is a plastic ring integrated into or permanently attached to the housing member 214. In this embodiment, the adhesive patch assembly 280 has an adhesive layer 280a and an adhesive release liner 280b. With the membrane support structure 212e in place (as previously described), the membrane reinforcement structure can remain in substantially the same plane while being removably attached to the membrane support structure 212e and permanently fixed to the adhesive release liner 280b. As previously described, the pre-filled membrane 285a is permanently fixed to the membrane reinforcement structure 285b. This device is easy to manufacture and can be optimized for impermeability at a specified minimum pressure by eliminating the need for a dedicated outlet port cover liner (285c, see below). Figure 26a This provides another cost advantage and results in optimal ease of use. The outlet port cover 285 is simply removed from the outlet port chamber 213b by removing the adhesive release liner 280b from the adhesive layer 280a (a task that the user must do anyway in order to attach the patch pump to the patient's body). Figure 26c A possible embodiment of the adhesive patch assembly 280 combined with the outlet port cap 285 as described is shown. A pre-filled membrane 285a is mounted on an adhesive release liner 280b using a double-sided adhesive ring, which also serves as a membrane reinforcement structure 285b. An adhesive mounting strip 280d is used to permanently attach the adhesive patch assembly 280 to a substrate 211a (not shown) at the bottom of the reservoir unit. A plurality of adhesive cuts 280c are introduced at least in the adhesive layer 280a, preferably cutting through all layers of the adhesive patch assembly 280 to allow access to the pump housing for functions such as filling the reservoir, bringing the needle assembly into position for drug delivery, or pressure compensation.

[0233] Further modifications to the outlet port cover within the scope of this invention include combinations of the outlet port cover and / or the membrane support structure with any other elements on the pump housing, or combinations of the outlet port cover concept with other functions. As an example of such extended functionality, the attachment of the outlet port cover may be designed to detach at low fluid pressures, intentionally allowing leakage to indicate to the user that the reservoir filling has been successfully completed, or to indicate to the user that the maximum pressure has been exceeded.

[0234] Another set of preferred embodiments illustrates an eighth aspect of the invention. They are based on what has been described previously. Figure 1 and Figure 2a , 2b The wearable, semi-disposable patch pumps shown are described in detail in the following paragraphs.

[0235] The patch pump is further improved by introducing numerous venting channels at the interface between the patch pump and the patient's body. These venting channels allow air and moisture to escape from the interface into the environment. By doing so, the temperature and humidity in the adhesive patch assembly and surrounding components are reduced, which improves the adhesion of the patch pump to the patient's body and thus improves the accuracy and reliability of drug delivery. While similar venting channels are known, their combination with other aspects of the invention results in... Figure 27 The new solution shown is as follows. As previously described, for patch pumps, it is advantageous to maintain good adhesion of the area surrounding the output portion of the needle assembly to the patient's body during drug delivery (ideally utilizing an impermeable fluid connection). Therefore, in embodiments of the invention, the venting channel is not connected to the outlet port chamber, but begins only at a distance that, for adhesive patch assemblies, is large enough to ensure the impermeable fluid connection, but small enough to improve adhesion in that area of ​​the adhesive patch assembly. The preferred range of the distance is 1 mm to 20 mm, and most preferably 5 mm to 10 mm. Figure 27 In a preferred embodiment, the venting channel is implemented as a ventilation recess 212f in the substrate 211a of the storage unit 200. This example of the embodiment also includes a membrane support structure 212e. Therefore, an adhesive layer covers the entire substrate 211a, including the substrate extension 212c, with cutouts for an outlet port and for the membrane support structure 212e. Figure 27 As is clearly visible, the ventilation groove 212f is arranged at a distance from the edge of the membrane support structure 212e. When the adhesive patch assembly (not shown) is mounted on the substrate 211a, the ventilation groove is covered by the adhesive patch assembly, creating a venting channel that allows air and moisture to pass from the closed inner end 212g of the ventilation groove 212f through to the open outer end 212h of the ventilation groove 212f, and from there exit to the environment outside the patch pump. Figure 27 It is also clearly visible that these venting channels are not connected to the outlet port chamber 213b. It is evident that the shape or number of venting channels is not important to their intended function. Although in Figure 27 In one embodiment, the venting channel is implemented as two substantially straight semi-cylinders, but they may have any other geometry, size, arrangement, or placement on the substrate 211a or substrate extension 212c, as long as they are not connected to the outlet port chamber 213b and have at least one open end facing the environment outside the pump.

[0236] As a result, the patch pump has improved permeability at the interface between the pump bottom and the patient's body, while still allowing optimal fluid-impermeable connection between the two sides of the interface surrounding the outlet port chamber, leading to improved accuracy and reliability of drug delivery. Furthermore, the arrangement of the present invention allows the pump housing and adhesive patch assembly to be designed to achieve fluid-impermeable properties at the minimum fluid pressure specified for this interface.

[0237] Another set of preferred embodiments illustrates a ninth aspect of the invention. They are based on what has been described previously. Figure 1 and Figure 2a , 2b The wearable, semi-disposable patch pumps shown are described in detail in the following paragraphs.

[0238] The patch pump is further improved by introducing a ventilation component at the interface between the inside and outside (i.e., the environment of the patch pump) of the reservoir unit. This ventilation component allows gaseous fluids (e.g., air) to pass through while simultaneously preventing liquid fluids from passing through the interface. By doing so, the pressure values ​​inside and outside the patch pump remain equal, thus the pressure conditions (e.g., the pressure gradient inside the reservoir and the fluid path) are not affected by external pressure fluctuations. This improves the drug delivery accuracy of the patch pump, and therefore improves the precision, reliability, and safety of drug delivery. While similar ventilation is known, its combination with other aspects of the invention leads to… Figure 28 The improved embodiment shown in -33. The pressure outside the patch pump may vary with atmospheric pressure or due to pressure changes within the compartment (such as an aircraft). The pressure inside the patch pump may vary due to volume changes (i.e., during filling or administration) and / or by temperature changes. As previously described, it is advantageous for the patch pump to maintain the absolute pressures inside and outside the pump equal; in other words, to keep the relative pressure between the inside and outside of the patch pump close to zero.

[0239] Figure 28 A bottom-up perspective view showing an embodiment of the patch pump 1. The patch pump 1 includes a pump unit 100 and a reservoir unit 200. An adhesive patch assembly 280 has an adhesive release liner 280b covering its bottom side. Figure 29 The patch pump 1 is shown in a bottom-up perspective view, exposing the adhesive layer 280a of the adhesive patch assembly 280 on its bottom side, where the adhesive release liner 280b has been removed. The fill port assembly 230 and the outlet port assembly 261 are partially visible through the adhesive cutout 280c. Figure 30An exploded perspective view shows an embodiment of a ventilation assembly 201, which includes a reservoir unit housing 211 forming a bottom wall 211g with a substrate 211a on its outer bottom side. A recessed surface 211o is formed in the bottom wall 211g, creating dimensions for a cavity 211q. The cavity 211q is interconnected or integrated with a passage 211c that accommodates a portion of a filling port assembly 230. Such a cavity 211q is fluidly connected to the environment or the external environment of the patch pump 1 via the passage 211c and an opening 211p. A through-hole 211n penetrates the bottom wall 211g in the recessed surface 211o. Along an axis perpendicular to the substrate 211a and extending from the top to the bottom of the reservoir housing 211, the exploded perspective view further shows: an annular membrane bonding patch 203, a circular semi-permeable pressure compensation membrane 216, a spacer structure 204, and an adhesive mounting tape 280d with an adhesive cutout 280c. In the assembled state, the improved ventilation assembly is constructed and facilitated by the following components: air contained in the compartment or internal volume 202 of the storage unit 200 is connected to the top side of a pressure compensation membrane 216 via a through-hole 211n, wherein the pressure compensation membrane 216 is sealed to a recessed surface 211o by an annular membrane bonding patch 203, which restricts a first portion of the volume of cavity 211q between the top side of the pressure compensation membrane 216 and the recessed surface 211o. The bottom side of the pressure compensation membrane 216 is exposed in a second portion of cavity 211q. The second portion of cavity 211q is vented to the environment through an opening 211p via a passage 211c, wherein an adhesive layer 280a and an adhesive mounting strip 280d form the bottom boundary of cavity 211q and passage 211c. A permeable spacer structure 204 is seated in cavity 211q between the bottom side of pressure compensation membrane 216 and the top side of adhesive layer 280. Due to its rigid yet permeable form, the permeable spacer structure 204 prevents the pressure compensation membrane 216 near the adhesive layer 280a from closing. Therefore, good ventilation and pressure balance are ensured even when the use of the patch pump 1 causes the adhesive layer 280a to bulge inward. Figure 31 The patch pump 1 is shown in a bottom-up perspective view, exposing its bottom side with a bottom wall 211g and a recessed surface 211o. The adhesive patch assembly 280 is not shown. A corrugated spacer structure 204 is placed in the cavity 211q. The pressure compensation membrane 216 is partially visible through the central hole of the corrugated spacer structure 204. Figure 32a The view shown is a bottom-up sectional perspective view, excluding the adhesive patch assembly 280 and the pressure compensation membrane 216. The sectional view reveals the internal volume 202 of the storage unit housing 211, and... Figure 32b show Figure 32aEnlarged details. The internal volume 202 of the storage unit housing 211 is limited by a wall 211b including a bottom wall 211g. A substrate 211a with a recessed surface 211o is formed on the outer side of the bottom wall 211g, wherein a through-hole 211 penetrates the bottom wall 211g, fluidly connecting the internal volume 202 to a first portion of the volume of the cavity 211q. The cavity 211q integrates a passageway 211c and accommodates a portion of the filling port assembly 230, and opens to an opening 211p. Figure 33a Showing a side perspective view of patch pump 1, and Figure 33b show Figure 33a Magnified details. The storage unit 200, including the adhesive patch assembly 280, is visible. The opening 211p has a recessed surface 211o and the top side of the patch assembly 280 as its edges.

[0240] Another set of preferred embodiments illustrates the tenth aspect of the invention. They are based on what has been described previously. Figure 1 and Figure 2a , 2b The wearable, semi-disposable patch pumps shown are described in detail below. As illustrated in the examples of Figures 34-39, the advantages of individual point bearings, combined with other aspects of the invention, result in improved embodiments.

[0241] The patch pump is improved by introducing a bearing assembly 101 into the drive mechanism 120 of the pump unit 100. The bearing assembly 101 includes a bearing element 126 that provides a bearing point 126a to the bearing surface 125b at the interface between the threaded rod 125 and the base sleeve 127.

[0242] Figure 34a A top perspective view depicting a pump unit 100 with a pump unit housing 102 and a cover 102a. The plunger rod 122 is guided within the cover 102a. Figure 34b Depicting passing through, such as Figure 34aAn enlarged sectional view AA of the pump unit 100 specified in the diagram is shown, along with a view of the components of the bearing assembly 101. The section is taken along a longitudinal axis 121, defined by a hollow plunger rod 122 with internal threads 122a and a rotatable threaded rod 125 with external threads 125c. The plunger rod 122 is rotatably fixed and axially guided within a cover 102a along the longitudinal axis 121. The threaded rod 125 is fixedly connected to the proximal end of a drive sleeve 128, and the proximal end of the threaded rod 125 forms a pivot 125a, which has a bearing surface 125b on its proximal end. A drive sleeve 128, together with a threaded rod 125, pivots about a longitudinal axis 121 in a base sleeve 127. A ball bearing 129 is accommodated between the distal end of the drive sleeve 128 and a cover 102a, and the proximal end of the drive sleeve 128 is rotatably mounted via a planar bearing 127a, which is formed between the distal section of a mounting hole 127a in the end wall 127b of the base sleeve 127 and the pivot 125a of the threaded rod 125. The proximal end face of the pivot 125a forms a bearing surface 125b. A spherical bearing element 126 is axially fixedly accommodated in the proximal end of the mounting hole 127a, and a bearing point 126a is formed on the longitudinal axis 121 proximal to the bearing surface 125b. A cavity 127c formed between the bearing surface 125b and the bearing element 126 can be filled with a lubricating substance 127d. A drive pinion 128a is formed or mounted on a section of the outer surface of the drive sleeve 128. The base sleeve 127 and the cover 102a, together with the bearing assembly 101, are fixedly housed in the pump unit housing 102 of the pump unit 100. The cover 102a and the pump unit housing are connected by a seal 102b. Figure 35 A side perspective view of a pump unit 100 with a pump unit housing 102 is depicted. Figure 36 Depicting Figure 35 A rotating side perspective view of the pump unit 100, showing a view of the cover 102a that closes the distal opening of the pump unit housing 102 and axially guides the plunger rod 122 along the longitudinal axis 121. Figure 37 A side perspective view of the bearing assembly 101 is depicted, in which the distal end face of the drive sleeve 128, the ball bearing 129, and the base sleeve 127 (coaxially surrounding the plunger rod 122) are visible. Figure 38 A side perspective view depicting the bearing assembly 101, a subset of the drive mechanism 120 (pump unit housing 102 and base sleeve 127 are removed). Pivot 125a, ball bearing element 126, plunger rod 122, drive sleeve 128 with drive pinion 128a, and ball bearing 129 (coaxially about longitudinal axis 121) are visible. Figure 39A cross-sectional perspective view of the base sleeve 127 is shown. A blind hole 127a is visible at the center of the end wall 127b of the base sleeve 127.

[0243] Although the invention has been described in detail in the accompanying drawings and the foregoing description, such description is to be considered illustrative or exemplary rather than restrictive. Those skilled in the art will understand and implement variations of the disclosed embodiments and practice the claimed invention by studying the drawings, the disclosure, and the appended claims. Given the nature of the invention, which has many aspects contributing to the overall optimal solution, it will be apparent to those skilled in the art that improvements described as different aspects for clarity can be applied in any choice and / or combination. For example, a solution provided for improving the outlet port seal can be well used to improve the filling port or any other seal in a drug delivery device. The filling port assembly can be combined with the outlet port assembly to further optimize the pump. In the claims, the word "comprising" does not exclude other elements or steps, and the indefinite articles "a" or "an" do not exclude a plurality. The fact that certain elements or steps are recited in different claims does not indicate that combinations of such elements or steps cannot be used advantageously outside of the actual claim dependents, and any further meaningful combination of claims should be considered disclosed.

[0244] List of reference numerals 1. Patch Pump 1a Covered surface 100 pump units 101 Bearing Assembly 102 Pump Unit Housing 102a cover 102b seal 113 Locking mechanism 113a locking spring 114 Opening side 120 drive mechanism 121 Longitudinal axis 122 plunger rod 122a internal thread 123 Plunger Cap 125 threaded rod 125a pivot 125b bearing surface 125c external thread 126 Bearing Components 126a bearing point 127 Base Sleeve 127a mounting hole 127b end wall 127c cavity 127d lubricant 127e thrust bearing 128 drive sleeve 128a drive pinion 129 ball bearing 140 System Control Circuit 141 Printed Circuit Board, PCB-PU 142 connection pins 150 rechargeable batteries 151 Battery Contacts 200 memory units 201 Ventilation Components 202 Internal volume 203 membrane-bonded patch 204-slot structure 211 Storage unit housing 211a substrate 211b wall 211c pathway 211d First Concave Section 211e fixed pin 211f Second Concave Section 211g bottom wall 211h sidewall 211i top wall 211j protruding edge 211k stable recess 211m incision 211n through hole 211o recessed surface 211p opening 211q cavity 212a bayonet connection 212b Rotation Axis 212c substrate extension 212d locking structure 212e membrane support structure 212f ventilation groove 212 Inner end 212 Outer end 213 First Shell Component 213a Export Port Opening 213b Exit Port Room 213c outlet port sealing plug cavity 213d outlet port sealing plug shaft 214 Shell Components 215 Housing seal 216 Pressure Compensation Membrane 221 Plunger 222 storage 222a storage entry 222b stable protrusion 222c storage outlet 222d storage tank outlet seal cavity 222e storage axis 222f Reinforcing Rib 222g filler port seal cavity 223 Storage tank outlet seal 230 Fill Port Component 231 Filler Port Seal 231a flange 231b opening 231c can puncture the septum 231d thermoplastic polymer 231e elastomer 231f cylindrical section 231g conical opening 235-pin guide / insert 235a conical opening 235b base 235c sleeve 235d opening or cut 238 First Seal 239 Second Seal 240 Hybrid Components 241 Base Frame 243 Printed Circuit Board, PCB-RU 244 batteries 245 Battery Opening 246 Holding element 250 inserter components 251 Sleeve Moving Assembly 252 Insert spring 253 Flexible sleeve retainer 254 Rigid Sleeve Retainer 256 Insertion Trigger 258 Rigid Sleeve 259 Flexible Sleeve 259a Flexible Sheath Inner Lumen 259b Flexible sleeve input seal section 260-pin assembly 260a Input Section 260b output section 261 Export Port Component 262 Rigid Outlet Port Seal Retainer 262a Export Port Channel 262b Export Port Channel Axis 263 Soft outlet port seal 270 Connector Structure 271a-271d connector components 272 Contact Arm 272a First Electrical Contact Area 272b Second Electrical Contact Area 273 Switching Arm 274 First battery contact arm 274a First Battery Contact Area 275 Second battery contact arm 275a Second Battery Contact Area 280 Adhesive Patch Assembly 280a adhesive layer 280b adhesive release liner 280c adhesive cut 280d adhesive mounting tape 285 Export Port Cover 285a pre-filled membrane 285b membrane reinforced structure 285c outlet port cover liner 290 Non-conductive body 291 First Opening 292 Second opening 293 Fixed pin 294 Bearing Pin 295 Upper guide rail 296 Lower guide rail 297 End stop surface 300 patients.

Claims

1. A ventilation assembly (201) for a drug delivery device storage unit (200), the ventilation assembly (201) comprising: - A storage unit housing (211) defining an internal volume (202) separate from the outside, the storage unit housing (211) including a bottom wall (211g) on ​​its outer side forming a substrate (211a), - An adhesive patch assembly (280), comprising an adhesive layer (280a) and a release liner (280b), - An adhesive mounting tape (280d) secures the top side of the adhesive layer (280a) to the substrate (211a). The bottom wall (211g) forms a recessed surface (211o) in the substrate (211a), creating a cavity (211q) between the recessed surface (211o) and the top side of the adhesive layer (280a), and the bottom wall (211g) forms one or more through holes (211n) that fluidly connect the cavity (211q) to the internal volume (202) of the storage unit housing (211). The ventilation assembly (201) further includes: - A waterproof and breathable pressure compensation membrane (216) is hermetically attached to the bottom wall (211g), wherein all of the one or more through-holes (211n) are covered by the pressure compensation membrane (216). Furthermore, the cavity (211q) leads to an opening (211p) to the outside, the opening (211p) having its edge along the top side of the recessed surface (211o) and the adhesive layer (280a). The cavity (211q) is characterized in that it accommodates a spacer structure (204), which is permeable.

2. The ventilation assembly (201) for a drug delivery device storage unit (200) according to claim 1, wherein, The spacer structure (204) is a corrugated, raised, or wrinkled sheet made of metal or rigid plastic.

3. The ventilation assembly (201) for a drug delivery device storage unit (200) according to any one of the preceding claims, wherein, The spacer structure (204) is a permeable element made of porous or perforated material.

4. The ventilation assembly (201) for a drug delivery device storage unit (200) according to any one of the preceding claims, wherein, The spacer structure (204) has one or more cuts and / or protrusions and / or depressions and / or punctures.

5. A ventilation assembly (201) for a drug delivery device storage unit (200) according to any one of the preceding claims, wherein, The spacer structure (204) occupies at least the space in the cavity (211q), wherein one or more through holes (211n) penetrate the bottom wall (211g).

6. A ventilation assembly (201) for a drug delivery device storage unit (200) according to any one of the preceding claims, wherein, The pressure compensation membrane (216) is placed on the outside of the bottom wall (211g) in the cavity (211q).

7. The ventilation assembly (201) for a drug delivery device storage unit (200) according to any one of claims 1 to 5, wherein, The pressure compensation membrane (216) is placed on the inside of the bottom wall (211g) in the internal volume (202) of the storage unit housing (211).

8. The ventilation assembly (201) for a drug delivery device storage unit (200) according to claim 6 or claim 7, wherein, The pressure compensation membrane (216) is directly welded or glued to the corresponding side of the bottom wall (211g).

9. The ventilation assembly (201) for a drug delivery device storage unit (200) according to claim 6 or claim 7, wherein, The pressure compensation membrane (216) is attached to the corresponding side of the bottom wall (211g) via a membrane bonding patch (203).

10. A ventilation assembly (201) for a drug delivery device storage unit (200) according to any one of the preceding claims, wherein, The pressure compensation membrane (216) is made of a fabric of expanded PTFE (ePTFE), which is a stretched form of the PFAS compound polytetrafluoroethylene (PTFE).

11. A ventilation assembly (201) for a drug delivery device storage unit (200) according to any one of the preceding claims, wherein, The pressure compensation membrane (216) is made of a fleece fabric composed of PET, polyester or polypropylene.

12. The ventilation assembly (201) for a drug delivery device storage unit (200) according to any one of the preceding claims, wherein, The pressure compensation membrane (216) is made of expanded polyethylene.

13. A ventilation assembly (201) for a drug delivery device storage unit (200) according to any one of the preceding claims, wherein, The spacer structure (204) is formed by or attached to the substrate (211a).

14. A ventilation assembly (201) for a drug delivery device storage unit (200) according to any one of the preceding claims, wherein, The spacer structure (204) is formed by or attached to the adhesive patch assembly (280).

15. A ventilation assembly (201) for a drug delivery device storage unit (200) according to any one of the preceding claims, wherein, The cavity (211q) is fluidly connected to or integrated into a passage (211c) suitable for receiving a fill port assembly (230).

Images