Improved bearing assembly for a wearable drug delivery device

Abstract

A bearing assembly for a pump unit of a drug delivery device is described, the bearing assembly comprising: a hollow plunger rod having proximal and distal ends defining a central longitudinal axis and having an internal thread; a threaded rod rotatable about the longitudinal axis, the threaded rod having an external thread and forming a pivot on a proximal section thereof, the external thread being configured to engage the internal thread of the plunger rod; a drive sleeve rotatably coupled to the threaded rod; a base sleeve having an end wall on a proximal side thereof; a bearing element, wherein the base sleeve forms a mounting hole in the proximal wall about the longitudinal axis to axially accommodate the bearing element and the pivot.

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 or methods for manufacturing the drug delivery device. Background Technology

[0002] There are many diseases that require routine treatment with medication administered subcutaneously, and numerous drug delivery devices have been developed to support patients in accurately and controllably delivering a measured amount 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 the patient administering insulin themselves with the aid of a multivariable-dose insulin pen or infusion pump. Alternatively, patch syringes, wearable syringes, or wearable pumps are patched or adhered to the patient's skin.

[0003] In contrast to classic syringes, increasingly sophisticated devices have been designed to support diverse treatments, ensure safety and reliability, and improve ease of use to the point that patients can administer medication themselves, thereby minimizing time-consuming and costly interventions performed by trained healthcare professionals. Examples of suitable self-treatment medication delivery devices include injection pens, auto-injectors, portable infusion pumps, and wearable patch pumps. Despite the technological complexity, an important requirement is to keep manufacturing and device costs as low as possible.

[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 out of the device and into the patient's subcutaneous tissue. Fluid impermeability of the fluid pathway is a fundamental requirement for ensuring the safety and accuracy of delivery. Longer infusion modes and reliable system monitoring rely particularly on controlled fluid pressure along the fluid pathway. While this is relatively easy to achieve with classic syringes, it becomes a challenge as device complexity increases. Designs for self-administration further increase the requirements, meaning use in non-sterile environments, by untrained individuals, 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 automatic inserters are typical solutions for improving ease of use. Reducing the number of mechanical parts during manufacturing and designing for easy assembly are typical methods for minimizing costs.

[0005] US 6,669,668 B1 discloses a drug delivery device having a disposable reservoir and a reusable pump module. The drug is manually filled into the disposable reservoir using a standard syringe. An administration set is used to deliver the drug from the pump into the patient's body.

[0006] A significant step towards ease of use is eliminating the need for a drug delivery device and designing a wearable patch pump that is small and has an adhesive patch to attach the pump to the patient during drug delivery. A typical patch pump design includes: a housing with a reservoir for holding the drug; a cannula for guiding the drug into the patient's body; and a needle assembly for establishing a fluid-proof connection between the reservoir and the cannula. For optimal ease of use, the cannula is made of a soft material, and an automatic 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-proof design, the reservoir is typically built into the housing and needs to be filled from the outside before use. Numerous sealing components are required to ensure the fluid path and the fluid-proof design of the housing. Special solutions are needed for the filling port (where the drug is introduced into the reservoir) and 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 patch pumps, which further increases design and manufacturing complexity. As the most complex 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 treatments with the highest level of ease of use and potentially low cost. Among other applications, they are the preferred solution for intermittent insulin delivery for the treatment of diabetes.

[0007] Clearly, there is a strong need for a wearable drug delivery device that provides 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 optimal solution, all involved components must be designed accordingly.

[0008] US 7,303,549 B2 describes a completely disposable patch pump for percutaneous fluid delivery. While this concept includes an automated insertion mechanism for the injection needle and provides a high level of ease of use, the lack of reusable parts results in the drawbacks of generating a large amount of waste and increasing treatment costs.

[0009] US 8,679,062 B2 describes a semi-disposable patch pump, which describes a modular patch pump in which one of these modules can be reused to reduce waste. However, ease of use is affected by the requirement to handle several different modules and the lack of an automated insertion mechanism for the injection needle.

[0010] US 9,993,595 B2 describes another example of a modular patch pump with a more compact design. Again, the lack of an automatic insertion mechanism affects ease of use.

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

[0012] In other technical fields, different types of materials are often combined to benefit from the advantageous properties of different materials. For example, US 5,597,990 B1 discloses an electrical switch integrated in a switch housing and designed for detecting 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 a folded metal blade, the free end of which protrudes from the switch housing to form a terminal for connection and 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 receiving a reservoir. The reservoir is closed by a needle insertion diaphragm and can be filled using an external filling device via a filling port located in the housing.

[0014] WO2017120251 discloses a filling aid 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. An external filling aid mechanism includes a conical opening for guiding a needle from an external filling device. The presence of the filling aid demonstrates the cumbersome nature of using a filling port integrated into the patch pump.

[0015] US 2019 / 0091404 A1 discloses a cartridge-based drug delivery device in which the reservoir has a sealed membrane at the outlet. The membrane is punctured by the needle assembly to connect the reservoir outlet to a needle assembly and prepare the pump for drug delivery. In a compact design, this membrane would be difficult to manufacture.

[0016] US 6,699,218 B2 describes a patch pump having 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 achieve fluid impermeability at a specified blocking pressure. Fluid impermeability at a specified blocking pressure is necessary for reliably detecting blockages in the fluid path.

[0017] The most common method for sealing the outlet port is by puncturing the diaphragm. Such an arrangement is disclosed in EP 1390089 B1 as part of an infusion set. More complex designs of patch pumps with automatic insertion mechanisms open up additional possibilities for new solutions by expanding upon this basic concept and optimizing the outlet port assembly for application-specific requirements.

[0018] EP 1682203 B1 discloses an outlet port assembly for a patch pump having a flexible sleeve and an insertion mechanism. The disclosed assembly includes numerous sealing components, making it more expensive and less optimal for manufacturing.

[0019] US 7,771,412 B2 describes an environmental seal for a fluid delivery device, wherein the outlet port is designed to comprise a cap consisting of two distinct components mounted within a housing. While two-shot molding is mentioned as a way to improve manufacturability and reduce costs, the proposed outlet port is quite complex. A soft plug remains inside the cap and is not arranged in a way that allows for further optimization by combining it with other functions.

[0020] In patch pumps with an automatic insertion mechanism, a fluid connection between the reservoir and the cannula's output is established 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. One objective is to provide a solution for closing the outlet port that is easy to use and suitable for low-cost manufacturing.

[0021] US 7,018,360 B2 discloses a semi-permeable outlet plug for supporting the filling and infusion of a patch pump with a needle insertion mechanism. The plug may be a sheet attached to an adhesive release liner of an adhesive patch. While simple, this concept tends to tear the semi-permeable sheet during plug removal and requires a solution with improved reliability and therefore improved ease of use.

[0022] US 6,749,587 B2 discloses a patch pump in which an adhesive is provided in a continuous ring surrounding an outlet port assembly to provide a protective seal around penetrated skin. Again, this simple concept can be expanded to include other features and find the overall optimal solution.

[0023] EP 3251585 A1 discloses an adhesive patch assembly for a patch pump, the patch assembly including structures to improve the reliability of the connection with the patient's body by allowing air and moisture to pass through the skin surface to reach the environment. This concept can also be extended and combined with other functions to achieve an optimal state of reliability and ease of use.

[0024] US 2002175062 A1 relates to a switching device for a pump, the switching device comprising a switch and a lighting device, wherein a minimum force must be applied to the switch before a switching signal is generated, and the switching device includes a method for operating the lighting device such that the lighting device emits a different light signal depending on at least one of the switching state of the switch and the operating state of the pump. Figure 1 An embodiment with a round window that includes a ventilation device on the side of the pump housing is depicted.

[0025] US Patent 2004092873 A1 discloses an external infusion device with a ventilated housing for infusing fluid from a reservoir into a 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. Furthermore, the drive mechanism is at least partially housed within the housing and operatively coupled to the at least a portion of the reservoir within the housing. Similarly, the housing is sized for user carrying without significant restriction on mobility. The electronic control circuitry is coupled to the drive system to control the infusion of fluid into the body. Additionally, 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] WO04006981 A2 discloses a device for delivering fluids (such as insulin, for example) to a patient. The device includes a flow path having an outlet port assembly adapted for connection to a percutaneous patient access tool, and includes a reservoir connected to the outlet port assembly. The device also includes a flow limiting system with an air removal filter and a flow limiter located within the flow path between the air removal filter and the outlet port assembly, the air removal filter being in communication with the flow path and allowing air to exit the flow path while preventing fluid from leaving the flow path. Among other features and advantages, the flow limiting system of the invention allows for venting or “pre-charging” of the flow path of the fluid delivery device prior to operation, enabling the device to accurately deliver a desired volume of fluid.

[0027] WO05077438 A1 discloses an external infusion device enclosed in a multi-shell housing. Within the outer walls, a first shell encloses a liquid reservoir and a drive mechanism. A second shell encloses a pump and electronics for controlling the drive mechanism to dispense the liquid from the reservoir according to a selected mode. A separate third shell encloses one or more batteries. The first and third shells are open to the atmosphere via a main vent with a hydrophobic barrier. The second shell is open to at least one of the first and third shells 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 shell is prevented from flowing into other adjacent shells.

[0028] WO 06061354 A1 provides a medical device comprising a transdermal device unit and a processing unit. The transdermal device unit is adapted to be mounted onto 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 skin of the subject. The processing unit includes a second housing having a lower surface and a processing assembly. The first housing and the second housing are adapted to be fixed to each other such that the lower surface of the second housing is allowed to move freely relative to at least a portion of the underlying skin surface or patch. Thus, the relatively flexible patch portion can statically and dynamically adapt to the skin surface to which it is mounted, without being restricted in its movement by the generally more rigid processing unit.

[0029] US 2016106914 A1 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 internal space to hold the at least one reservoir and the at least one other unit. The at least one housing has at least one vent port formed on one or more of its walls. The at least one vent 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 ambient air communication with the at least one other unit requiring air to enable operation of the at least one other unit.

[0030] US 2010106091 A1 discloses an outpatient infusion pump assembly and its housing, the housing having a cap and a base providing a closed 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 housed within the housing cavity. Furthermore, the system includes a seal providing a liquid-tight seal between the cap and the base. A through-channel extends from the closed cavity to the outside of the housing, and an infusion tube extends through the through-channel. A fluid-tight seal is formed around the infusion tube. A vent is provided in the housing, which maintains a balanced pressure between the closed cavity and the atmosphere, while preventing contaminants from entering the closed cavity and fluid from leaving the closed cavity.

[0031] US Patent 2014135693 A1 discloses a medical multi-chamber pump having a pump membrane and a venting channel to ensure the movement of the membrane. The venting channel is covered by a breathable band to protect the interior of the pump from external contamination.

[0032] US 2015080842 A1 discloses an infusion device having a ventilated feature for infusing fluid from a reservoir into a body, the infusion device being connectable at a connection point to an infusion adapter, the infusion device comprising: a drive mechanism operatively coupled to 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; wherein 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 adapter, or at the connection point of the infusion adapter.

[0033] WO 13188866 A1 discloses a pressure and temperature compensated drug infusion device configured to maintain its intended drug delivery rate by monitoring atmospheric effects. The device may include one or more vents allowing gas to pass between the exterior and interior of the device's housing. The device may also include one or more pressure and / or temperature sensors, readings obtained from which can be used to determine malfunctions in the device's ventilation and / or pressure changes that could lead to unexpected over- or under-delivery of the drug.

[0034] WO 14015257 A1 discloses several embodiments of an infusion pump system that can be configured to provide air pressure balance between ambient air pressure outside the infusion pump system and internal air pressure inside the infusion pump system. Particularly in embodiments, the infusion pump system may be equipped with an air-permeable liquid-tight seal along the interface between the pump body and a cap device configured to be attached to the pump body.

[0035] WO 14197389 A1 discloses several embodiments of an infusion pump system that can be configured to provide a desired level of resistance to fluid entering the pump housing while providing air permeability to balance the pressure difference between the inside and outside of the pump housing. Furthermore, some embodiments can detect when moisture within the housing of the infusion pump system is greater than or equal to a threshold level and can activate one or more patient safety measures.

[0036] WO 14209621 A1 discloses an invention generally for a novel ventilated fluid cartridge for use in medical infusion devices. The disclosed invention describes a medical cartridge having an internal venting structure and a hydrophobic venting material to allow pressure equalization between the reservoir chamber of the infusion device and the external environment without the need for an expensive and difficult-to-maintain vent located in the housing of the infusion device.

[0037] US Patent 2016089505 A1 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 to dispense fluid from the fluid reservoir. The fluid delivery device includes a pressure management system at least partially defined in said portion of the drive system for discharging air from the chamber.

[0038] EP3251585 A1 discloses a device that can be installed on the body, particularly a patch for a medical component, including a housing portion adapted to receive the medical component and having a bottom side, and further including a fastening device connected to the housing portion and adapted to secure the housing portion to a patient's body such that the bottom side faces the body, wherein a fluid guiding member is disposed on the bottom side of the housing portion for guiding fluid emanating from the body to the periphery of the housing portion.

[0039] WO19034943 A1, the disclosure relates to a disposable module that can be coupled to a reusable module to form a pump for metering a substance to a user in the coupled state, including a housing enclosing the following components: - a reservoir for receiving the substance to be dispensed; and - an extendable sleeve, particularly a rigid sleeve and / or a flexible sleeve, said rigid sleeve and / or flexible sleeve (one or more) being fluidly connected to the reservoir at least after insertion or in a permanent manner (i.e., also before insertion).

[0040] EP 3928814 A1 discloses a drug delivery device for medical treatment, 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 a fluid tight seal for the outlet port opening and a fluid tight connection between the housing and the rigid outlet port seal retainer.

[0041] EP2618867 B1 discloses an infusion pump system comprising: a disposable first part including a medical cartridge; and a reusable second part including a motor and a clogging sensor, and not containing any part of the drug fluid path of the infusion pump system; wherein the disposable first part and the reusable second part are configured such that the reusable second part can be brought into an operating position, in which operation of the motor causes the drug to be dispensed from the medical reservoir, and wherein the thrust bearing may be a conventional ball bearing, an angular contact bearing, or a combination of radial / thrust bearings. The thrust bearing may include a ball bearing, a retainer guiding the ball bearing, a thrust washer, and a radial ball bearing traveling on the thrust washer and also on the thrust surface of a drive gear. The radial ball bearing can withstand thrust from the lead screw in the retraction direction. The radial bearing can be pressed onto the shaft and, in order to resist axial forces, pressed or bonded into the rear wall of the chassis or more specifically into or bonded into the opening in the gear cap.

[0042] EP3705149 B1 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 components housed within the housing and operatively coupled to the reservoir to deliver fluid from the reservoir to the user's body via a fluid path. 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 a bearing for support.

[0043] US10099005 B2 discloses a drive mechanism for a drug delivery device, wherein the end of a lead screw extending from the second gear is supported by a bearing. The bearing is mounted in a bearing mounting hole in a 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] US2017043098 A1 discloses a unit comprising a connecting sleeve and a threaded rod forming a rigid unit, and elements in which these components are mounted, namely a guide sleeve, a bearing retainer and a ball bearing ring, and a thrust sleeve. This unit constitutes a delivery device that converts the rotational motion of an input member in the form of the connecting sleeve into thrust of a delivery element in the form of the thrust sleeve. Its input member can be detachably connected by the connecting sleeve to be locked to prevent relative rotation with respect to the drive mechanism. Furthermore, it can be detachably connected via the connecting sleeve to be locked to prevent relative rotation with respect to the retaining device (i.e., the housing).

[0045] WO20020680 A1 discloses a drug delivery device comprising: a housing having an opening; a piston rod having a proximal end and a distal end; at least one portion having an interface adapted to engage the opening to guide the piston rod during distal or proximal movement 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 the at least one first attachment element and / or the at least one second attachment element are radially resiliently deformable 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 the at least one first attachment element and the at least one second attachment element (if attached to each other), but preventing disengagement of the at least one first attachment element and the at least one second attachment element (if received in the opening). Summary of the Invention

[0046] One object of the present invention is to provide an improved drug delivery device that is accurate, reliable, easy to use, and cost-effective, thereby overcoming the shortcomings of the prior art or introducing an alternative to the prior art. Several aspects of the invention contribute to overall excellence. All of them are applicable to a wide variety of drug delivery devices, such as pen injectors, patch injectors, mobile pumps, or patch pumps.

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

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

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

[0050] The terms “injection system” or “syringe” 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 having a cannula or needle that remains in the patient’s skin for an extended period (e.g., several hours). Unless otherwise explicitly stated, the term “pump” refers to an infusion system, and in the context of this invention, it generally 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, "seal" or "protrusion" does not exclude the fact that there may be two "seals" or "protrusions" that functionally or structurally achieve the purpose of "one seal" or "one protrusion".

[0052] Description of the present invention In a first aspect of the invention, a modular concept for a semi-disposable patch pump is introduced, thereby providing an optimal trade-off between ease of use and reusability of components. This is achieved by reducing the number of components that the user must handle to two: a reservoir 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 processing steps that the patient needs to perform to apply the pump.

[0053] The reservoir unit includes a reservoir unit housing and a base plate mounted on an adhesive patch (wherein the base plate 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 components will typically include: a reservoir having a reservoir outlet; a pump mechanism; and a needle assembly connected to the reservoir outlet to deliver 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 for inserting a needle into the patient's body without the user applying any force. The pump mechanism may, for example, include a plunger movably mounted in the reservoir, allowing the medication to be pressed out of the reservoir through the reservoir outlet by moving the plunger. Any type of energy can be used to drive the automatic insertion mechanism: energy stored in the reservoir unit (such as a pre-loaded insertion spring) or energy derived from an external source (such as rotation generated by the pump unit). This also includes the possibility of using the same drive unit as that used to drive the pump mechanism to drive or release the automatic inserter. The pump unit includes all components intended for multiple or continuous use, such as: a pump unit housing; a power source, such as a rechargeable battery; a drive mechanism with a drive unit for driving the pump mechanism in the reservoir 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 reservoir, the drive unit may be a combination of, for example, a motor, gearing, and a coupling to 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. This connection must be secure and reliable, allowing for easy separation of the pump unit and reservoir unit to replace disposable parts, while ensuring optimal safety and reliability during normal use should the pump unit be accidentally separated or removed.

[0055] When the two units are connected, the patch pump is preferably shaped to be substantially edgeless for optimal wearability and to prevent accidental removal of the patch pump from the patient's body. The external shape of the encapsulated pump components during normal use also helps to prevent accidental removal of the pump unit from the reservoir unit. Still aiming for optimal ease of use, the mechanical interface between the reservoir unit and the pump unit preferably includes a bayonet coupling, where no button pressing or slider movement is required to release the connection, while still ensuring a mechanical connection with optimal rigidity and minimal axial clearance, as 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 base plate, thereby sealing the pump's substantially edgeless encapsulated outer surface. The closing movement of the reservoir unit is essentially a rotation about an axis defined by the bayonet connector. To open the bayonet, the user pulls on one side of the reusable unit opposite to the axis of rotation of the bayonet, at which side the pump unit is lifted away from the plane of the base plate to release the pump unit.

[0057] While the concept of a semi-disposable patch pump as described in this invention includes any kind of locking mechanism for bayonet connectors, mechanisms that allow the same processing steps to unlock and open the connection are particularly easy to use and are therefore preferred. Examples of such embodiments include mechanical latches, magnetic locks, or a pair of Velcro® bars that engage and disengage via a simple push-pull mechanism.

[0058] Although the external shape of the patch pump is optimized for wearability, the pump unit can still be unlocked and removed if the patient's body part with the pump attached accidentally rubs against the edge. This edge can slide under the patch pump on the open side, causing the pump unit to be lifted off the plane of the base plate. The locking mechanism can open, and the pump unit can be brushed off the patient's body. To avoid such accidental removal, an improved embodiment of the patch pump includes a base plate that extends from the bottom of the reservoir housing along the direction of the pump unit between the open side and the bayonet axis. While this extended base plate effectively reduces the risk of accidental removal of the pump unit from the reservoir unit, it makes it more difficult for the patient to intentionally remove the pump unit. Therefore, a further improvement of the patch pump according to the invention is a cut at the edge of the base plate. The cut serves to allow the patient's fingers to slide at least partially under the pump unit on the open side of the pump while the longer edge remains external. 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 treatment. Despite its ease of use, additional features ensure the patch pump is safe to 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 having 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, the drug delivery device includes a base frame comprising a conductive connector structure including an electrical contact area 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 area can be accessed by the external device from the outside of the non-conductive body. The base frame may further be 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 for a drug delivery device as described in the preceding paragraph, the base frame comprising: 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 be contacted 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, the guide member being combined with the non-conductive body to form an integral part.

[0063] According to existing techniques, different electrical contact elements and supports for holding the contact elements in place within the drug delivery device are individually and mechanically connected to each other, for example, by thermal riveting, riveting, insertion or pressing into sockets, or by using snap-lock connections. The handling of these different electrical components is complex. 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 significant reduction in the number of individual components and also allows for the combination of several functions into a single assembly. The electrical connector structure includes electrical conductors, contacts, tracks, or strips adapted to establish electrical connections between electrical components supported or held by a 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, thereby forming a monolithic component with extended functionality. Other support elements can be, for example, support pins for printed circuit boards, retaining elements for holding batteries on the non-conductive body, guide elements for guiding movable needle assemblies or other movable elements of the inserter mechanism, 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 parts or connector components of the connector structure can be made of any conductive material, such as metals, metal alloys, conductive plastics, or conductive composite materials. 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 part or connector component, or it may include multiple conductive parts 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 part, such as a single metal sheet, in a first production step. The shape of this sheet will include all connector components plus some connecting bridges therebetween to form a single conductive part. In a second production step, the conductive sheet or component is overmolded to form an integral part with a non-conductive frame that holds all connector components and connecting bridges. In a third production step, the connecting bridges are removed (e.g., by punching), resulting in an integral part containing a connector structure with one or more separate electrical paths. This manufacturing process is significantly easier and more efficient than using overmolding techniques, where two or more conductive connector components are all embedded as separate parts.

[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 part 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 separated 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] A non-conductive body of the drug delivery device is injection molded around a connector structure, and thus at least partially encapsulates the connector structure. The connector structure is therefore supported or held in place by the non-conductive body. This allows the connector structure to be securely placed within, 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 nonconductive body is preferably a single integral component. Several elements (such as, for example, retaining elements, guide rails, mechanical stop elements, support elements, or support pins) are integrally formed within the nonconductive body. This means that these elements are preferably made of the same material as the nonconductive body.

[0070] A non-conductive material is injection molded around the connector structure, allowing the electrical contact area of ​​the connector structure to be accessed from the outside of the non-conductive material. This means that the non-conductive material is not designed to prevent the electrical contact area of ​​the connector structure from making contact with the intended connection contacts. The electrical contact area of ​​the connector structure can be designed, for example, in the form of an arm or rod protruding from the non-conductive material, or the non-conductive material can have an opening or recess that allows an external device to contact the electrical contact area through that opening or recess.

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

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

[0073] In a preferred embodiment, the drug delivery device is a patch pump comprising reusable and disposable parts. The reusable parts may include a drive mechanism and a control unit. The disposable parts are adapted to be replaced after each infusion and may include a reservoir containing the drug, a mixing 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 assembly, the cannula moving assembly will include related parts for handling the movement of the needle assembly within the inserter assembly, particularly retainers for rigid cannulas and flexible cannulas.

[0074] In a preferred embodiment, the non-conductive body forms a guide member for the movement of the guide pin assembly itself or the cannula moving assembly. The term "forms" means that the guide member is integrally formed in 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 member can guide the movable portion of the needle assembly or sleeve moving assembly along a linear or straight motion path, along a curved path, along a rotary path, or along a combination of linear, curved, and rotary motion paths. The guide member can be implemented, for example, in the form of a rail, nut, protrusion, or profile.

[0076] Because the guide member is formed as a single component within the non-conductive material, no means of connecting the guide member to the non-conductive material are required; for example, snap-fit ​​or screw fasteners are unnecessary. The guide member 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 insertion position where the cannula is inserted into the user's skin.

[0077] Preferably, the guide member is a linear guide for guiding the needle assembly itself or a portion of the cannula moving assembly along a linear motion path. "Linear" means the motion path is a straight line, causing the needle assembly to move along a straight line. The guide member 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 nonconductive body may include an end stop surface integrated as an integral part within the nonconductive body, wherein the end stop surface is adapted to restrict movement of the needle assembly or cannula movement assembly along a first direction. The end stop surface is integrally formed in the nonconductive body. Preferably, the end stop surface defines an extended position or an initial position of the needle assembly. The needle assembly can move from the initial or starting position to an extended or inserted position, where the cannula has pierced the user's skin. The end stop surface may be, for example, a cushioning stop, a buffer, or simply an element protruding along 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 made entirely of metal, or of metal and other material components, conductive composite materials, or of metal and additional non-metallic materials. Preferably, the connector structure is made of a single conductive metal sheet. This allows for easy and efficient production of the connector structure.

[0080] In this configuration, the connector structure is preferably manufactured by punching and bending. This means that in a first step, the outline of the connector structure is defined by punching it out of a metal sheet, and in a second step, the connector structure is further formed by bending. If the connector structure comprises more than one connector component, these connector components are initially mechanically connected to each other via auxiliary or temporary bridges or connectors. After the non-conductive material has been injection molded around the circuit, these bridges are eliminated or interrupted by a stamping step. This means that the finished connector structure may include several connector components or other electrical paths that are different and separate in terms of current. In this way, the connector structure can be manufactured efficiently and at a lower 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 member. This means that the connector structure includes at least two connector members, each connector member including a resilient element or contact arm that carries the electrical contact areas. Therefore, these electrical contact areas can bounce or flex when an external component mechanically and electrically contacts them. This can help establish a reliable electrical connection between the external contact element and the electrical contact areas of the connector structure. The external contact element may belong to other devices (e.g., a charger) or may belong to any other system component that can be connected to the connector structure (e.g., a unit of a modular pump or an attachment 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 electrically contactable directly or indirectly with the second connector member. The first and second connector members are electrically isolated from each other. If the switching arm electrically contacts the second connector member, an electrical connection is established between the first and second connector members, and thus an electrical signal can be transmitted. Therefore, the switching arm can be switched between a conductive and a non-conductive state via a movable sleeve moving assembly.

[0083] The generated signals can indicate, for example, 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 switch arm must be positioned so that the button, external device, or needle assembly can mechanically contact the switch arm to switch the lever between a conductive and a non-conductive state.

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

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

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

[0087] Furthermore, the non-conductive body may include a retaining element integrated as a single component to hold the battery. Additionally, the connector structure may include a battery contact element integrated as a single component to electrically contact the held battery. The retaining element may be, for example, an arm, clamp, retaining tab, or tongue. Thus, 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 secured in place by the retaining element, the battery mechanically and electrically contacts the battery contact element of the connector structure. The battery contact element may be implemented, for example, in the form of a pin, tab, tongue, or arm, and may be integrated as a single component into the connector structure.

[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 connect to the positive terminal and a second battery contact element is adapted to connect 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 also to an inserter assembly having a cannula movement assembly. The base frame includes: 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 is accessible from the outside of the non-conductive body. The non-conductive body includes a guide member for guiding movement of the needle assembly or the cannula movement assembly, the guide member being integrated as a single component into the non-conductive body. 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 heater assembly or melt release module with a heating element for releasing the puncture process using the needle assembly. The heater assembly is supported by a non-conductive material.

[0091] The release of the puncture process may involve a linear or rotational movement of the needle assembly from an initial or starting position to an extended position, where the cannula has pierced the user's skin. The heating element of the heater assembly preferably causes a fuse to blow or break, which holds the biased needle assembly or cannula moving assembly in its initial position. If the fuse blows or breaks, the insertion trigger or holding device of the mixing assembly breaks or expands, allowing the biased needle assembly or cannula moving assembly to move the cannula freely and pierce the user's skin with a portion of the needle assembly.

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

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

[0094] Preferably, the holding structure for rigidly holding the PCB-RU to the non-conductive material is integrated into the non-conductive material as a single integral component. This structure may include pins, tabs, or arms formed as a single integral component. The PCB-RU may be secured to the holding 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 the pressure requirements derived from the intended function. To achieve the design of this invention, the following pressure requirements have been specified: - To allow successful filling of the reservoir through the filling port in the housing, at least the reservoir seal and the filling port seal must be fluid-proof for a filling pressure of at least 6 bar. - To allow for successful blockage detection, the seals along the fluid path of the agent must be impermeable to fluid at least 2 bar of blockage pressure. - In order to allow for successful protection against intrusion from the environment, at least the seals of the housing must be impermeable to fluids against an environmental overpressure of at least 0.24 bar.

[0096] Meeting these requirements and finding overall optimal sealing at all interfaces related to the function of the drug delivery device is of particular importance. It is further apparent that the pressure requirements given above are merely examples to illustrate the advantages of the invention and should in no way limit the application of the concepts described herein to specific pressure ranges.

[0097] In a third aspect of the invention, a concept for an improved fill port assembly is described to overcome the disadvantages of the prior art. The improved fill port assembly ensures fluid impermeability under filling pressure, facilitates easy assembly, improves device life and robustness, and additionally allows the reservoir to be secured relative to the housing.

[0098] This objective is achieved 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 fill port assembly located within the wall of the housing and accessible from the outside for filling the reservoir, the fill port assembly including a conical opening for receiving a needle and a puncturable fill port seal separating the reservoir from the outside, characterized in that: the fill port assembly includes an insert adapted to be received by a channel in the wall of the housing, and wherein the fill port seal provides a sealing function between the housing and the reservoir. A seal between the housing and the reservoir is provided to ensure that no fluid can pass between the reservoir and the wall of the housing.

[0099] 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 solid reconstituted prior to injection. The reservoir may be a cartridge made of a flexible material, a non-foldable reservoir, or a foldable reservoir. The drug delivery device includes a housing comprising walls separating an internal volume from an external one. The housing may be constructed with any number of components joined together to form a substantially closed shell around the internal volume. The reservoir is located within the internal volume. A filling port assembly is located within or part 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 multi-purpose reservoir. Optionally, the reservoir is filled only once, and the unit comprising the reservoir is discarded after use. The filling port assembly includes a conical or conical 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) containing a drug for filling an empty reservoir. The filling port assembly includes a puncturable filling port seal that separates the reservoir from the outside. The puncturable filling port seal may include a puncturable diaphragm. The filling port seal or the diaphragm of the seal can be punctured by a needle for filling the reservoir. Furthermore, the filling port assembly includes an insert adapted to be received by a channel in the wall of the housing or received within the filling port seal, thereby receiving the filling port seal within the channel of the housing. The filling port assembly is assembled from the outside of the housing. The filling port seal provides a seal between the housing and the reservoir. The filling port seal can provide multiple seals to different sections or components within the drug delivery device, and the seal can be a direct seal between the housing and the reservoir or an indirect seal via other housing parts. Combining multiple seals in the filling port assembly reduces the number of required parts. Using an insert as part of the filling port assembly has the advantages of inserting it into a channel in the wall from the outside during assembly, which may also secure other parts (e.g., housing parts) or components (such as reservoirs) relative to at least a portion of the housing of the drug delivery device or the reservoir unit of the drug delivery device, while simultaneously establishing a seal or multiple seals. Therefore, the filling port assembly combines the features of enabling the filling of an empty reservoir, sealing the reservoir relative to the housing, and securing the cartridge or reservoir. Using an insert separate from the housing has the advantages of allowing both parts to 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 helps reduce the risk of particle abrasion, needle clogging, or needle damage. A conical opening further facilitates needle insertion through the filling port, especially for visually impaired users.

[0100] The insert of the drug delivery device preferably includes a conical opening extending from a base. The conical opening defines a longitudinal axis, and the base is preferably connected to a larger diameter access point 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 conical opening of the insert is adapted to receive and guide a needle tip, for example, toward a diaphragm of a filling port seal. The conical opening is angled relative to the longitudinal axis. The opening of the cone is wide to facilitate needle tip entry. The cone angle between the longitudinal axis and the cone surface ranges from 20 to 40 degrees, more preferably from 25 to 35 degrees, and most preferably from approximately 30 degrees.

[0101] 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 leakage from the interior of the housing to the exterior, or prevents reversed contamination from the exterior from entering the housing. The first seal may be part of a sterile design to protect internal components from environmental influences. The first seal can improve the shelf life or lifespan of the device.

[0102] 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 be received in a second recess or recessed section of a channel within a 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 channel, 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 lateral dimension smaller than that of 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 conical opening and located between the base of the insert and the recessed section of the housing or the channel surrounding the housing. Receiving the flange of the fill port seal in a second recessed section in the wall protects the fill port seal from lateral movement and aligns the parts (e.g., the channel in the housing, the fill port seal, and the insert) before final assembly and / or securing the cartridge. The housing wall and / or the base of the insert facing the fill port seal, configured to receive the fill port seal in the second recessed section, may have raised or protruding structures to locally compress the resilient sealing material of the flange.

[0103] The drug delivery device can be further improved by additionally sealing the filling port of the reservoir 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 conical opening), and once the device has been assembled, the reservoir inlet is aligned relative to a channel in the housing. The reservoir inlet is preferably oriented perpendicular to the longitudinal axis of the reservoir. The reservoir inlet is also aligned relative to the conical opening and the diaphragm, which is part of the filling port seal, such that needle penetration of the diaphragm ensures that the drug can be filled into the reservoir. Therefore, the fluid port assembly provides a fluid-impermeable seal to the reservoir (preferably, the reservoir inlet), and thus prevents drug leakage from the reservoir into the housing or to the outside. The fluid port assembly also prevents contaminants from the outside from entering the reservoir and can be part of a sterile barrier.

[0104] The filling port seal of the drug delivery device may provide a second seal between the filling port seal and the inlet of the reservoir, and this seal is preferably oriented radially in a direction perpendicular to the longitudinal axis of the conical opening. The second seal is preferably axially displaced from the first seal. By positioning the two seals at different locations, two sealing functions are achieved in a single component, each possessing (independent) sealing properties, and the materials or dimensions can be adapted to specific needs.

[0105] Preferably, the insert and the fill port seal secure the reservoir relative to the housing. Thus, by inserting the fill port seal and the insert from the outside into the housing, the reservoir, preferably already present inside the housing, is secured. This securing can 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 parts forming the fill port assembly. The securing preferably uses the fill port assembly or a part of the fill port assembly that is at least partially located inside the inlet of the reservoir. Alternatively, a neck section or the body of the reservoir can be used for securing. The additional use of the fill port assembly for reservoir securing means that sealing and securing are combined, which improves the assembly of the device and reduces the number of parts.

[0106] Preferably, the filling port seal includes a hole extending from the flange and terminating in a pierceable diaphragm. This hole 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 hole. The cylindrical section preferably connects a first seal and a second seal.

[0107] Preferably, the insert of the drug delivery device includes a sleeve extending from a conical opening, beginning at a narrow section of the conical opening, and the sleeve is adapted to be received within an orifice of a fill port seal. Thus, the base of the cone can be connected to the sleeve. The sleeve is connected to the narrow end of the conical opening and preferably extends along the longitudinal axis of the cone. The sleeve guides the needle tip from the conical opening toward a puncturable diaphragm of the fill port seal. This guidance ensures that the diaphragm is punctured perpendicularly to the membrane forming the diaphragm, preventing diaphragm tearing and leakage along the needle during reservoir filling. This guidance also prevents the needle from contacting the inner wall of the inlet, which would carry the risk of abrasive particles from the inlet wall and reduced puncture depth. Furthermore, the sleeve of the insert is coaxially arranged within an orifice 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.

[0108] 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.

[0109] The outer surface of the cylindrical section is preferably press-fitted into the inlet of the reservoir—thereby a) establishing a second seal (due to the elasticity or partial elasticity of the outer surface of the cylindrical section) and b) securing the reservoir to prevent lateral movement. The filling port assembly secures the reservoir such that, preferably due to the elastic properties of the outer surface of the cylindrical section engaging the reservoir's inlet, a shock absorber exists between the reservoir and the housing. This is advantageous for the device because it improves impact resistance, for example, during drop tests.

[0110] 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, zirconia, or alumina particles). One advantage of using metal or toughened plastic is that it prevents the needle tip from abrading particles from the insert or even becoming trapped within it. Another advantage of using metal or toughened plastic is improved abrasion resistance of the insert to the point of reusable reservoirs, for example, where the needle is repeatedly guided and inserted through the filling port assembly without damaging the insert. Therefore, the lifespan of the insert and associated device (especially for reusable devices) can be improved.

[0111] 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 higher modulus to provide the mechanical strength needed to secure the reservoir, while simultaneously improving fit during assembly during pump manufacturing. The advantage of using an elastomer is that its elasticity is beneficial for forming the seal and optionally for shock absorption. Examples of thermoplastic polymers can be polybutylene terephthalate (PBT), polycarbonate, or polycarbonate alloys such as cycoloy, acrylonitrile butadiene styrene copolymer (ABS), or high-modulus polyurethane (PUR). Examples of elastomers can be EPDM rubber, polydimethylsiloxane rubber PDMS (preferably in LSR form), or elastomeric polyurethane (PUR) or thermoplastic elastomer (TPE). The thermoplastic polymer and elastomer are preferably chosen to meet biocompatibility requirements according to ISO 10993 because the parts of the fill port seal may come into contact with pharmaceuticals. 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.

[0112] The insert (more preferably, the base of the insert) of the fill port assembly includes a recess, opening, or cutout 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 pin is preferably integrally formed on the housing and made of a thermoplastic polymer. The retaining pin is oriented substantially parallel to the conical axis, and the engagement between the cutout and the retaining pin ensures proper alignment of the insert with the other parts of the fill port assembly and housing after installation. The engagement between the retaining pin and the opening facilitates assembly and ensures rotational fixation of the insert relative to the housing. The insert may be secured to the housing by thermally riveting at least one of the retaining pins (e.g., by heating and deforming the retaining pin). This axial and rotational fixation is fundamental for reliable and sufficient contact pressure of the fill port seal and therefore for achieving the expected sealing function of the fill port at up to the specified fill pressure.

[0113] 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 to secure the diaphragm and reservoir. The inserts can be made of a different material than the housing material.

[0114] 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, the method comprising the steps of: - Provides housing, reservoir, filler port seals, and inserts. - Insert the reservoir into the housing from the outside along an axis perpendicular to the cone's axis, followed by... - The filling port seal is inserted from the outside into the channel 211c in the wall of the housing along the conical axis, followed by... - Insert the insert 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 the first seal and the second seal and securing the reservoir to the housing.

[0115] 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 heat riveting the retaining pin to secure the insert to the housing. Alternatively, ultrasonic welding, laser welding, adhesives, or thermal welding can be used to secure the insert to the housing.

[0116] In a fourth aspect of the invention, a conception is described for an improved seal for a drug delivery device at the interface between the reservoir and the needle assembly that draws the drug from the reservoir toward the cannula. The reservoir outlet seal design ensures fluid impermeability under choking pressure, facilitates easy assembly, and improves the device's lifespan and robustness.

[0117] This objective is achieved by a drug delivery device comprising: a housing having a reservoir located within the housing to contain a drug; a needle assembly having an inlet portion and an outlet portion; and a puncturable reservoir outlet seal; wherein the reservoir includes a reservoir housing that is at least partially rigid, the reservoir housing having a reservoir outlet seal cavity that is at least partially cylindrical, the reservoir outlet seal cavity being integrated as an integral part into the reservoir housing; 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, punctured by the inlet portion of the needle assembly during manufacture, and to form a fluid-impermeable connection between the reservoir and the inlet portion of the needle assembly. The at least partially cylindrical design of the reservoir outlet seal facilitates ensuring fluid impermeability under filling and / or choking pressures and an easier assembly process compared to other geometries. In a variation of this design, a soft reservoir outlet seal may be manufactured as an integral part together with the rigid reservoir housing using two-shot injection molding.

[0118] In a fifth aspect of the invention, a conception is described of an improved seal for a drug delivery device at the interface between a rigid cannula (as part of the input portion of the needle assembly) and a flexible cannula (as part of the output portion of the needle assembly). The flexible cannula input seal design ensures fluid impermeability under choking pressure, facilitates easy assembly, and improves the device's lifespan and robustness.

[0119] This objective is achieved by a drug delivery device comprising: a housing having a reservoir located within the housing to contain a drug; a needle assembly having an input portion and an output portion; wherein the needle assembly includes a flexible cannula having an open distal end and a rigid cannula at least partially and slidably disposed within a lumen of the flexible 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 flexible cannula is part of the output portion of the needle assembly; wherein the proximal input end of the flexible cannula forms a sliding flexible cannula input seal configured to slide on the rigid cannula while a tightening pressure is applied to ensure a fluid-impermeable seal under choking pressure.

[0120] In a sixth aspect of the invention, a conception for improved seals at the interface of the housing and the output portion of the needle assembly for a drug delivery device is described. The improved outlet port seal ensures fluid impermeability of the housing under ambient pressure, reduces the number of components in the drug delivery device, facilitates easy assembly, saves costs, and improves the device's lifespan and robustness.

[0121] This objective is achieved by a drug delivery device comprising: a housing having an encapsulating surface separating an internal volume from an external one; a reservoir located within the housing to contain a drug; a needle assembly having an inlet portion and an outlet portion; and an outlet port assembly, wherein the housing includes at least two components 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 for providing a passage from the interior to the exterior of the outlet portion of the needle assembly; and the outlet port assembly is configured to connect the housing and the outlet portion of the needle assembly. An impermeable connection is formed between them; the outlet port assembly includes: a rigid outlet port seal holder having an outlet port channel that is at least partially tubular and defines an outlet port channel axis, the outlet port channel being configured to receive the output portion of the needle assembly; and a soft outlet port seal that is attached to the rigid outlet port seal holder during the manufacture of the drug delivery device; the soft outlet port seal is configured to be pierced by the output portion of the needle assembly during the manufacture of the drug delivery device; and thereby the soft outlet port seal is further configured to provide an impermeable closure of the outlet port opening of the housing when the outlet port assembly is mounted on the housing.

[0122] Three exemplary methods for realizing this concept are clearly described in the following paragraphs.

[0123] An outlet port seal design according to the concept described is achieved by manufacturing the outlet port assembly as an integral part using a dual-shot injection molding process, the integral part comprising a rigid outlet port seal retainer and a flexible outlet port seal.

[0124] Another outlet port seal design according to the concept described is achieved by connecting the outlet port assembly to one of the at least two housing components and manufacturing the outlet port assembly as a monolithic part using a two-shot injection molding process. This monolithic part includes at least one of the at least two housing components, a rigid outlet port seal retainer, and a flexible outlet port seal. In terms of including a portion of the housing, this multifunctional component may specifically include other seals of the housing, such as seals at the mechanical interface between the reservoir unit and the pump unit of a semi-disposable patch pump.

[0125] Another outlet port seal design according to the concept described is achieved by adapting a rigid outlet port seal holder to further include: an outlet port sealing plug cavity defining an outlet port sealing plug cavity axis and open at at least one end to receive a flexible outlet port seal; the outlet port sealing plug cavity is arranged to intersect the outlet port channel at an angle of at least 10 degrees, preferably at least 45 degrees, between the outlet port channel axis and the outlet port sealing plug cavity axis; the outlet port sealing plug cavity axis and the outlet port channel axis intersect at an angle of at least 10 degrees, preferably at least 45 degrees; the flexible outlet port seal is inserted into the outlet port sealing plug cavity during the manufacture of the drug delivery element; and the flexible outlet port seal is configured to tightly seal the outlet port sealing plug cavity and the outlet port opening when mounted in the rigid outlet port seal holder.

[0126] Another advantageous feature of the outlet port seal design according to the concept described is achieved by the following steps: modifying the outlet port sealing plug cavity to include a narrowing and / or flattening portion at the outlet port opening to improve the pressing and / or shaping of the soft outlet port seal at the intersection with the outlet port channel. Increased pressing results in higher fluid impermeability at pressure, and the flat shape of the outlet port seal makes it easier to puncture during manufacturing.

[0127] Another advantageous feature of the outlet port seal design according to the concept described is achieved through the following steps: modifying the shape of the housing in one of the devices described above; and introducing a recess from the encapsulating surface of the housing at the outlet port opening. With the outlet port located in the recess, the patch pump can be manufactured to be ready to use with the output portion of the needle assembly already passing through the outlet port, thus providing sufficient sealing and ease of use without any parts protruding from the encapsulating surface of the housing. Furthermore, the recess in the housing forms an external outlet port chamber between the recessed outlet port opening and the encapsulating surface of the housing, which allows the reservoir and fluid path to be filled prior to 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.

[0128] Regardless of the implementation method, the features of the outlet port seal design according to the described concept are particularly advantageous for semi-disposable patch pumps with a needle assembly, 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 lumen of the flexible sleeve; and a needle insertion mechanism configured to bring the output portion of the needle assembly having at least the open distal end of the flexible sleeve from a first position inside the outlet port cavity to a second position outside the outlet port cavity in the housing. This insertion mechanism greatly improves ease of use.

[0129] In a seventh aspect of the invention, a conception is described for an improved seal for a patch pump at the interface of the environment in the area of ​​the housing and the outlet port prior to application of the pump to a patient's body. The outlet port cap design ensures fluid impermeability at the minimum filling pressure specified for use with the patch pump, supports the filling and infusion process, and facilitates easy assembly and use of the device.

[0130] This objective is achieved by a drug delivery device having an outlet port (e.g., the device described in the preceding aspect of the invention) located in a recess of a housing and an outlet port cover, 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 a manner that prevents fluid from entering or leaving the outlet port chamber while allowing air to pass through; the outlet port cover comprises a membrane made 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 having slits for the outlet port opening.

[0131] In an eighth aspect of the invention, a conception is described of an improved seal for the patch pump at the interface of the housing and the environment in the area of ​​the outlet port after the pump has been attached to the patient's body. The design of the housing and the adhesive patch assembly improves the reliability and robustness of the drug delivery device, while also providing easier and more comfortable use of the patch pump.

[0132] This objective is achieved by a drug delivery device as described above and used as a 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 prepared for drug delivery; the adhesive patch assembly includes a removable adhesive release liner for protecting the adhesive layer from accidental adhesion before use, particularly during the preparation of the patch pump for drug delivery; an outlet port cap is permanently fixed to the adhesive release liner and removably connected to the housing; and the outlet port cap is configured to be removed from the housing together with the adhesive release liner during the preparation of the patch pump for drug delivery.

[0133] The design of the housing and adhesive patch assembly in the outlet port region is particularly advantageous for patch pumps as described above, wherein the housing further includes a membrane support structure arranged around the outlet port chamber; the membrane support structure is adapted to protrude outward from the housing 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 when the outlet port cap is removably attached to the housing; the membrane support structure is configured to provide a fluid-impermeable connection between the outlet port cap and the housing during preparation of the patch pump for drug delivery and thereby tightly seal the outlet port chamber.

[0134] 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, a further improvement to the patch pump design at the interface between the housing and the environment in the outlet port area involves introducing numerous airing channels at a distance from the outlet port. These allow air and / or moisture to exit 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 described above, whereby the housing and / or adhesive patch assembly further include at least one ventilation structure having: at least one inner end, which is closed and arranged 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 outer end, which remains open and is arranged at the peripheral edge of the housing and / or adhesive patch. The horizontal distance of the airing channels from the outlet port chamber is important for maintaining a tight seal around the outlet port and preventing the ventilation structure from connecting to the outlet port chamber. The ventilation structure is configured to allow air to pass from the inner end through to the outer end and reach the environment of the patch pump. During drug delivery, the ventilation channels 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 more towards the housing—if the ventilation structure is formed by the housing or by other layers of the adhesive patch assembly.

[0135] In a ninth aspect of the invention, an improved pressure-compensated ventilation assembly for 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 providing safer and more comfortable use of the patch pump.

[0136] According to the invention, these objectives are achieved by a ventilation assembly for a reservoir unit of a wearable drug delivery device, the ventilation assembly comprising: a reservoir unit housing defining an internal volume spaced from the outside, the reservoir unit housing including a bottom wall forming a base plate on the bottom outer side of the reservoir unit housing; an adhesive patch assembly including an adhesive layer and a release liner; an adhesive mounting strip securing a top side of the adhesive layer to the base plate; wherein the bottom wall forms a recessed surface in the base plate, the recessed surface creating a cavity between the recessed surface and the top side of the adhesive layer, and the bottom wall forming one or more through-holes fluidly connecting the cavity to the internal volume of the reservoir unit housing. The ventilation assembly further comprises: a waterproof and breathable pressure-compensating membrane hermetically attached to the bottom wall, wherein all of the one or more through-holes are covered by the pressure-compensating membrane, and wherein the cavity opens to an opening to the outside, the opening being defined by the recessed surface and the top side of the adhesive layer, and wherein the cavity accommodates a permeable spacer structure. Due to its rigid yet permeable form, the permeable spacer structure prevents the adhesive layer from sealing the pressure-compensating membrane nearby. Therefore, good ventilation and pressure balance are ensured even when the use of the patch pump 1 causes the adhesive layer to bulge inwards. This could occur if the target tissue undergoes movement or if the patch pump is exposed to external forces, such as if the user is lying on the pump or wearing tight clothing. In other words, the adhesive layer is restricted from bulging further inwards, i.e., it is restricted from contacting the membrane when it reaches the rigid spacer structure.

[0137] Furthermore, the ventilation assembly for a drug delivery device reservoir unit according to the invention may include a spacer structure comprising a corrugated, curved, or pleated sheet, strip, or mesh formed of metal or rigid plastic. In this 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.

[0138] 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 made of a porous or perforated material having a uniform surface. In this 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.

[0139] 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 this 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 the adhesive layer.

[0140] Furthermore, the ventilation assembly for a drug delivery device reservoir unit according to the invention may include a spacer structure that occupies at least one space in the cavity 211q where the one or more through holes pierce the bottom wall. This arrangement saves space.

[0141] Furthermore, the ventilation assembly for the reservoir unit of a drug delivery device 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.

[0142] Furthermore, the ventilation assembly for a drug delivery device reservoir unit according to the invention may include a pressure-compensating membrane placed on the inner side of the bottom wall within the internal volume of the reservoir unit housing. This arrangement further protects the membrane.

[0143] Furthermore, the ventilation assembly for a drug delivery device reservoir unit according to the invention may include a pressure compensation membrane, which is directly welded or glued to a corresponding side of the bottom wall. This ensures the adhesion is airtight.

[0144] Furthermore, the ventilation assembly for a drug delivery device reservoir unit according to the invention may include a pressure-compensating membrane, which is attached to a corresponding side of the bottom wall via an annular membrane adhesive patch. This ensures a tight seal of the attachment, simplifies assembly, and improves membrane ventilation.

[0145] Furthermore, the ventilation assembly for the reservoir unit of a drug delivery device according to the invention may include a pressure-compensating membrane made of a fabric of expanded polytetrafluoroethylene (ePTFE) (a stretched form of PFAS compound polytetrafluoroethylene (PTFE)). This fabric ensures breathability while maintaining water resistance.

[0146] Furthermore, the ventilation assembly for a drug delivery device reservoir unit according to the invention may include a pressure-compensating membrane made of a nonwoven fabric composed of PET, polyester, or polypropylene. This ensures breathability while maintaining water resistance without the presence of perfluoroalkyl and polyfluoroalkyl substances (PFAS).

[0147] Furthermore, the ventilation assembly for the reservoir 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 mono-substance alternative to perfluoroalkyl substances and polyfluoroalkyl substances (PFAS).

[0148] 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 the base plate 211a. This simplifies the assembly process and improves reliability in use.

[0149] 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.

[0150] 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 channel adapted to receive a filling port assembly. This arrangement saves space.

[0151] In a tenth aspect of the invention, a bearing assembly is described in a drive mechanism for a pump unit, at the interface between a threaded rod and a base sleeve, for improving the operational stability of a patch pump. The bearing assembly includes bearing elements providing support points for support surfaces. Abnormal pump conditions, such as reservoir blockage, can be inferred from inappropriate variations in motor parameters such as power, current, or inductance. Variations in axial load are transmitted by the drive mechanism and occur in corresponding variations in torque on the motor side of the drive mechanism. Friction from within the drive mechanism results in additional torque. Friction generated by 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, thus obscuring the inference of the abnormal pump conditions. One object of the invention is to increase the signal-to-noise ratio of the measured motor parameters and improve the performance of inferring abnormal pump conditions from them.

[0152] According to the invention, these objectives are 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 the hollow plunger rod having an internal thread; a threaded rod rotatable about the central longitudinal axis, having an external thread and forming a pivot on its proximal end section, the external thread being configured to engage the internal thread of the plunger rod; a drive sleeve rotatably coupled 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 in the mounting hole proximal to the pivot, wherein the bearing element supports a proximal-pointing force of the threaded rod when the plunger rod is driven in the distal direction during delivery operations, and wherein the bearing element axially holds the rotating threaded rod in place relative to the base sleeve.

[0153] 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 formed as a through hole having an inner annular protruding edge or flange in the proximal section of the mounting hole. This simplifies the assembly process of the bearing assembly and improves the placement accuracy of the bearing elements.

[0154] 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 sliding bearing. In this way, the threaded rod and drive sleeve are precisely axially guided and retained rotatable about a central longitudinal axis. The effect of the sliding bearing is to hold the support point between the bearing element and the pivot on the central longitudinal axis.

[0155] Furthermore, the bearing assembly for a pump unit of a drug delivery device according to the invention may include a bearing element having a convex surface on its distal side. The convex surface is rotationally symmetric with respect to a central longitudinal axis. Such a single support point may be formed between the convex surface of the bearing element and the surface of the pivot.

[0156] Furthermore, the bearing assembly for a pump unit of a drug delivery device according to the invention may include a spherical bearing element. This allows for easy orientation-independent assembly and cost-effective off-the-shelf sourcing of the bearing element.

[0157] Furthermore, the bearing assembly for a pump unit in a drug delivery device according to the present invention may include bearing elements made of metal or ceramic compounds. This ensures an extended service life with consistently low frictional losses.

[0158] Furthermore, the bearing assembly for a pump unit of a drug delivery device according to the invention may include bearing elements made of medium alloy cold work tool steel, such as rolling bearing steel like material 1.3505 / 100Cr6. This ensures extended service life with consistently low frictional losses and 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 invention may include a threaded rod made of a metal alloy, such as steel 1.4305 / X8CrNiS18-9 or brass or bronze. In addition to the good machinability of this material, the material, together with the bearing element, results in a friction pair with excellent frictional values.

[0160] Furthermore, the bearing assembly for a pump unit of a drug delivery device according to the invention may include a base sleeve made of glass fiber reinforced polyamide, such as GRILAMID LV-50H FWA, or a polymer blend comprising polycarbonate (PC) and acrylonitrile / butadiene / styrene (ABS). This provides improved rigidity and good dimensional stability when temperature changes occur.

[0161] 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 support surface to contact a support point on the distal side of the bearing element at the central longitudinal axis. This provides an extended service life with constant low frictional loss and stabilizes the support point on the central longitudinal axis.

[0162] Furthermore, the bearing assembly for a pump unit of a drug delivery device according to the invention may include a lumen or cavity defined in a mounting hole by support surfaces of bearing elements and a pivot, the lumen or cavity containing a lubricating substance, such as a silica-thickened synthetic hydrocarbon grease, for example NYOGEL 774. This provides an extended service life with consistently low frictional losses and prevents corrosion.

[0163] 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 a drive torque relative to a central longitudinal axis. This allows for a space-saving kinematic arrangement.

[0164] 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 about the central longitudinal axis, or a combination of linear and rotational guidance.

[0165] Furthermore, the bearing assembly for a pump unit of a drug delivery device according to the invention may include a ball bearing housed between a cap and a drive sleeve. The axis of rotation of the ball bearing is on a central longitudinal axis. This arrangement, coaxially holding and stabilizing the drive sleeve about the longitudinal axis at the distal end of the drive sleeve, provides low frictional loss for the rotation of the drive sleeve and the threaded sleeve. Together with the pivot at the proximal end guided by the sliding 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.

[0166] Further within the scope of the invention is a drug delivery device pump unit, which includes a pump unit housing and / or drive mechanism adapted to accommodate a bearing assembly according to the invention. Attached Figure Description

[0167] The subject matter of the invention will be explained in more detail in the following text with reference to preferred exemplary embodiments illustrated in the accompanying drawings, in which: Figure 1 Perspective views of the patch pump as seen from above (away from the patient, left side) and from below (towards the patient, right side) are depicted; Figure 2a , Figure 2b Refers to the mechanical interface between the pump unit and the reservoir unit; Figure 2a The drive mechanism of the patch pump spanning these two units is described; Figure 2b The bayonet connector between the pump unit and the reservoir unit of the patch pump is depicted; Figure 3a , Figure 3b Refers to the steps of attaching the pump unit to the reservoir unit of the patch pump; Figure 3a A patch pump is depicted, wherein the pump module is connected to the reservoir module at a 30° angle via a bayonet. Figure 3b A cross-sectional view of the patch pump at the locking mechanism is depicted, with the locking mechanism closed (left: full cut, right: enlarged view of the locking mechanism). Figure 4 A patch pump is depicted that is attached to the patient's body and ready to deliver medication. Figure 5 The reservoir unit of the patch pump is depicted without a front side housing and an adhesive release liner; Figure 6a , Figure 6b A perspective view of a hybrid assembly with a sleeve movement component; Figure 6a A perspective view of the hybrid assembly is depicted, with the sleeve moving assembly in its initial position; Figure 6b Depicting Figure 6a A hybrid assembly, but in which the sleeve moving assembly is in the extended position; Figure 7 Depicting Figure 6a , Figure 6b A bottom view of the mixed components; Figure 8a -c refers to the perspective view of the base frame; Figure 8aA perspective view of the base frame, which includes a non-conductive body and a connector structure, is depicted. Figure 8b A perspective view of the non-conductive elements of the base frame is depicted from bottom to top; Figure 8c The connector structure of the base frame is depicted; Figure 9a , Figure 9b A perspective view of a reservoir unit with a filled port after it has been fixed by hot stemming; Figure 9a A perspective view of a storage unit is depicted, which is partially assembled and flipped up from bottom to top to show the filling port at the bottom of the unit; Figure 9b A cross-section of a storage unit is depicted, which has a fixed filling port assembly and a storage inlet; Figure 10 The image depicts a structure as seen before the filled port is secured by heat staking. Figure 9a , Figure 9b The cross-section of the storage unit; Figure 11 Depicting from Figure 9a , Figure 9b The cross-section of the storage unit, in which a filler port seal is inserted and no insert is present; Figure 12 Depicting the process from before installing the populated port component Figure 9a , Figure 9b The cross-section of the storage unit; Figure 13 A perspective view of the insert is depicted; Figure 14 The filling port seal is depicted in perspective (left) and cross-section (right); Figure 15 A perspective view of the reservoir, including the plunger, is depicted. Figure 16 An exploded view of the reservoir unit is depicted, showing the insertion of the cartridge and filling port assembly into the reservoir unit housing to form the reservoir unit. Figure 17 A perspective view of the pump unit is depicted, with the housing removed; Figure 18 A perspective view of the storage unit is depicted, with a portion of the casing removed; Figure 19 A patch pump with a reservoir outlet seal is depicted in cross-section of the reservoir outlet. Figure 20 A cross-sectional view of a patch pump with a flexible sleeve inlet seal is depicted. Figure 21a , Figure 21b A schematic diagram of a patch pump, which has an outlet port; Figure 21a A patch pump with an outlet port in a flat area of ​​the housing is depicted; Figure 21b A patch pump with an outlet port in a housing is depicted, wherein a recess is located at the outlet port; Figure 22a , Figure 22b The export port component in 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 22b A cross-sectional view of an embodiment of a fully assembled patch pump is depicted, the patch pump having Figure 22a Export port components; Figure 23a -c refers to the export port component of the second preferred embodiment of the export port; Figure 23a A preferred embodiment of the exit port assembly is depicted in a perspective view cut through the exit port channel; Figure 23b A preferred embodiment of the outlet port assembly is depicted in a cross-sectional view (right); Figure 23c A cross-sectional view of an embodiment of a fully assembled patch pump is depicted, the patch pump having Figure 23a Export port components; Figure 24a -d refers to 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 an external perspective view (left) and a cross-section view of the outlet port (right). Figure 24b A cross-sectional view of the passage through the outlet port, as seen from inside the housing, is depicted to further illustrate the outlet port sealing plug cavity prior to assembly. Figure 24c A cross-sectional view is depicted as seen from inside the housing through the outlet port channel, wherein a soft outlet port seal is installed into the outlet port sealing plug cavity; Figure 24d A cross-sectional view of the outlet port after the seal has been pierced by the needle assembly is depicted; Figure 25a -e refers to the export port component in the fourth preferred embodiment of the export port; Figure 25aThe housing component with an integrated rigid outlet port seal retainer is shown in an external perspective view (left) and a cross-section view of the outlet port (right). Figure 25b A cross-sectional view of the passage through the outlet port, as seen from inside the housing, is depicted to further illustrate the outlet port sealing plug cavity prior to assembly. Figure 25c A cross-sectional view is depicted as seen from inside the housing through the outlet port channel, wherein a soft outlet port seal is installed into the outlet port sealing plug cavity; Figure 25d Depicting insertion into Figure 25b The soft outlet port seals are placed before (left) and after (right) the outlet port sealing plug cavity; Figure 25e A cross-sectional view of the outlet port after the seal has been pierced by the needle assembly is depicted; Figure 26a -c refers to an outlet port that has an outlet port chamber and an outlet port cover; Figure 26a The outlet port cover of the closed outlet port chamber is depicted; Figure 26b An outlet port cover in an embodiment having a membrane support structure is depicted; Figure 26c An exploded view of the adhesive assembly combined with the outlet port cover is depicted. Figure 27 A ventilation recess is depicted 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 depicting a patch pump with the adhesive patch assembly exposed on its bottom side; Figure 30 An exploded perspective view depicting an embodiment of the ventilation assembly; Figure 31 A bottom-up perspective view depicting the patch pump with its bottom side exposed (adhesive patch assembly removed); Figure 32a and Figure 32b Refers to the base plate and bottom wall of the storage unit housing; Figure 32a A sectional perspective view is depicted, viewed from the bottom upwards; Figure 32b Depicting Figure 32a Magnified details; Figure 33a and Figure 33b Refers to the opening of the ventilation component; Figure 33a A perspective side view of patch pump 1 is depicted; Figure 33b Depicting Figure 33a Magnified details; Figure 34a and Figure 34b Refers to the top and sectional views of the pump unit, including the bearing assembly; Figure 34a A top view of the pump unit is depicted; Figure 34b Describing as Figure 34a The enlarged sectional view AA through the pump unit specified in the figure; Figure 35 A perspective side view of the pump unit is depicted; Figure 36 Depicting Figure 35 A rotated perspective side view of the pump unit; Figure 37 A perspective side view of the bearing assembly is depicted; Figure 38 A perspective side view of the bearing assembly (with the base sleeve removed) is depicted. Figure 39 A sectional perspective view of the base sleeve is depicted.

[0168] The reference symbols used in the accompanying drawings and their main meanings are listed in summary form in the name list. In principle, the same reference symbols are used for the same parts in the accompanying drawings. Detailed Implementation

[0169] As outlined in the introductory paragraph, the present invention has many aspects, all of which contribute to the overall optimization of an improved drug delivery device that is accurate, reliable, and easy to use, while still being suitable for complex treatments at the lowest possible cost. Although using... Figure 1 and Figure 2a , Figure 2b The example of the wearable patch pump shown illustrates the most preferred embodiment, but it is evident that the same aspects of the invention can also be used to improve any other kind of drug delivery device, provided comparable features exist. Cost-effectiveness is achieved, in particular, by introducing new and improved manufacturing and / or assembly methods for drug delivery devices, as described in the following aspects.

[0170] Figure 1A perspective view of a preferred embodiment of the drug delivery device according to the present invention is depicted. 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 having a fluid path for carrying the drug from the reservoir into the patient's body. At the bottom of the reservoir unit 200, an adhesive patch assembly 280 is included 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 connector. Figure 1 (Left) Shows the complete patch pump 1 as seen from above, with both units connected. In the context of this invention, "above" or "top" refers to the side of the pump facing away from the patient's body when the pump is 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 (Left) In the middle, arrow 114 indicates the direction toward the open side of the patch pump 1, where the pump unit 100 is lifted away from the bottom of the reservoir unit 200. Figure 1 (Right) shows the same pump turned around to obtain a bottom view of patch pump 1, which has an adhesive patch assembly 280.

[0171] like Figure 2a As illustrated, 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 settings, drug delivery, and monitoring. When the drive mechanism is connected to the storage unit 200, the battery can be recharged from an additional battery in the disposable storage unit 200.

[0172] A drive mechanism 120 mechanically acts from a threaded rod 125 via a plunger rod 122 on a plunger 221 in a reservoir 222 to dispense medical substances 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 a patient. To ensure safe handling, the patch pump is manufactured, transported, stored, and prepared for use entirely within the encapsulated shape of the pump 1, together with the needle assembly 260. The encapsulated shape is an imaginary surface that encapsulates the housing of the pump 1, smoothly bridging all gaps and recesses (if any) to the closed housing. It is the shape of the pump 1 as perceived by the user from a distance and is relevant when it relates to aspects of use such as handling or wearability. In this embodiment, preparing the patch pump 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. An inserter assembly is included in reservoir unit 200 and is configured to bring the output portion of needle assembly 260 (specifically the open distal end of needle assembly 260) out of the pump's encapsulation shape and into the patient's body once the pump is ready to begin drug delivery. In a preferred embodiment of the patch pump, 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 to allow drug delivery.

[0173] The rechargeable battery provides power to the drive mechanism and system control circuitry. The system control circuitry controls the drive mechanism and can exchange data with external control devices, such as via a wireless data connection. Furthermore, the rechargeable battery provides power to the inserter assembly in the storage unit 200.

[0174] Figure 2b A view from above shows the source Figure 1 A semi-disposable patch pump in which the pump unit 100 and the reservoir unit 200 have been removed and separated, wherein the adhesive patch assembly 280 is at the bottom facing the patient's body, and the bayonet connector 212a is in a detached state.

[0175] The first set of preferred embodiments illustrates a first aspect of the invention. They are based on the foregoing description. Figure 1 and Figure 2a , Figure 2b The wearable, semi-disposable patch pumps shown are described in further detail in the following paragraphs.

[0176] The overall 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 more information.) Figure 1 and Figure 2a , Figure 2bAs is evident from the general description of the embodiments, the patient has only two components to assemble: a reusable pump unit 100, all of which is intended for multiple or continuous use; and a disposable reservoir unit 200, all of which is intended for single use. Figure 2b A preferred embodiment of the semi-disposable patch pump according to the invention is shown, wherein the pump unit 100 and the reservoir unit 200 are ready for application. The reservoir unit 200 is shown externally as having a reservoir unit housing 211 mounted on an adhesive patch assembly 280 and a mechanical interface to the pump unit (particularly shown as a bayonet connector 212a on both units), the rotation axis 212b of which is shown on both units, and a locking structure 212d integrated into the reservoir unit housing 211. The locking mechanism for the bayonet connector includes the locking structure 212d on the reservoir unit and a flexible locking spring 113a on the pump unit (see...). Figure 3b The base plate 211a is integrated into the reservoir 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 base plate may be a single integral part or a combination of parts permanently joined together and attached to the adhesive patch assembly 280. The bayonet connector design includes the definition of the pump's open side 114, which refers to the pump unit being lifted away from the base plate to open the connector and remove the overall orientation or external surface of the pump unit. Figure 2b In the diagram, the base plate is shown to have a base plate extension 212c on the open side 114. When the pump unit 100 rotates about the rotation axis 212b of the bayonet, it is apparent that the base plate extension 212c may only cover an area on the open side of the pump starting from the rotation axis of the bayonet connector, since it would otherwise prevent the pump unit from being connected to the reservoir unit.

[0177] exist Figure 16 and 18 The figure illustrates a preferred embodiment of the reservoir unit, with selected parts removed to reveal the internal components. Specifically, reservoir 222 is shown as having 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 be aligned with the rotation axis 212b of the bayonet connector in the fully assembled state. Figure 2b The walls of the reservoir unit housing facing the pump unit coincide with and are substantially orthogonal to the walls of the reservoir unit housing.

[0178] exist Figure 2a , Figure 2b and Figure 17The figure illustrates a preferred embodiment of the pump unit, with selected parts removed to show the internal components. Specifically, the drive mechanism 120 is shown as having: a drive unit implemented as a threaded rod 125 mounted in and cooperating with the plunger rod 122; a rechargeable battery 150; and system control circuitry 140. The threaded rod 125 and the plunger rod 122 are arranged substantially parallel to and substantially orthogonal to the rotation axis 212b of the bayonet connector in the fully assembled state, and to the wall of the pump unit housing facing the reservoir unit.

[0179] To apply the patch pump 1 and begin drug delivery, the patient removes the reservoir unit 200 from the packaging. If the reservoir is not pre-filled with medication, the patient fills the reservoir 222 with medication. The pump unit 100 will typically have been activated from its previous 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 open angle along the bayonet rotation axis 212b. Depending on the design of the bayonet configuration, this open 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 connector 212a and folds the pump unit 100 downward onto the plane of the base plate 211a. In an example of a preferred embodiment, the plunger rod cap 123 at the tip of the plunger rod 122 in the pump unit connects to an opening behind the plunger 221 in the reservoir unit. With the bayonet connector in place, the pump unit 100 folds downward onto the plane of the base plate 211a to close the connection. Figure 3a This step is illustrated with the pump unit at a 30-degree connection angle. The user ensures the bayonet connector 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 reusable pump unit engages with the locking structure 212d integrated into the housing of the disposable reservoir unit 200, locking the bayonet connector in the closed position. Figure 3b The diagram illustrates this state. It is evident that the bayonet connector of the present invention may also include any other locking mechanism, such as a magnetic lock, a velcro, a latch, or an adhesive lock, provided that the lock can be released without introducing additional unlocking steps.

[0180] exist Figure 4In this study, patch pump 1 has been applied to the bodies of 300 patients and is ready for drug delivery. The encapsulation surface or external shape of patch pump 1 is essentially edgeless and suitable for wearing, with minimal risk of the device being rubbed off when it slips over an edge (such as a door frame).

[0181] After successful delivery of the medication from 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 one. The bayonet connection is opened by simply lifting the pump unit 100 off the plane of the base plate 211a at the open side 114 of the pump. The same movement unlocks the locking mechanism and opens the bayonet. To further facilitate this step, a cut 211m may be formed on the base plate 211a or the base plate extension 212c on the open side 114 of the pump 1. The cut 211m reduces the size of the base plate 211a at the position where the patient's fingers grasp the pump unit 100 to unlock and remove it from the reservoir unit 100. The cut may 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 produce a tactile effect. Therefore, the dimensions of the cut 211m along the base plate 211a and / or the base plate extension 212c are typically 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 base plate 211a and / or the base plate extension 212c. Figure 3a An example of a cut is shown at the edge of the base plate extension 211a. When folded to the opening angle of the bayonet connector, the pump unit can be detached from the reservoir unit and attached to a new reservoir unit to continue treatment.

[0182] Another set of preferred embodiments illustrates a second aspect of the invention. These are based on the embodiments described above. Figure 1 and Figure 2a , Figure 2b The wearable, semi-disposable patch pumps shown are described in further detail in the following paragraphs.

[0183] Figure 5 , Figure 6a and Figure 7 The reservoir unit 200 is shown (from bottom to top), with selected parts removed to allow observation of the interior of the reservoir unit 200. The reservoir unit 200 includes a reservoir unit housing 211, a reservoir 222 containing medical substances, a mixing assembly 240 according to the invention, a button battery 244, and an adhesive patch (not shown) for connecting the patch pump 1 to the user's skin.

[0184] Figure 6a , Figure 6b and Figure 7 A hybrid component 240 is depicted, which is arranged as follows: Figure 5 The storage unit 200 shown is inside the storage unit housing 211. The mixing assembly 240 includes parts of the inserter assembly 250, particularly the sleeve movement assembly 251. Figure 6a A hybrid assembly 240 is depicted, in which the cannula movement assembly 251 is in a biased initial position. The inserter assembly 250 moves the cannula movement assembly 251 from the biased initial position into an extended position for drug delivery. This movement can be, for example, by an elastic element (such as an insertion spring 252 built into the inserter mechanism). Figure 7 The system drive, wherein at least one of these 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 A bottom view of the hybrid component 240 is shown.

[0185] like Figure 6a As shown, the hybrid assembly 240 additionally includes a printed circuit board PCB-RU 243, a button battery 244, and a base frame 241 for supporting the hybrid assembly 240, the PCB-RU 243, and the battery 244.

[0186] The structural features of the base frame 241 are described in detail below. The function of the hybrid component 240 is then described.

[0187] Figure 8a The base frame 241 is depicted separately. The base frame 241 includes: a connector structure 270 having four connector members 271a-271d; and a non-conductive body 290 made of plastic, which is injection molded around the connector structure 270.

[0188] In the first manufacturing step, connector components 271a-271d are stamped from metal sheets. At this stage, connector components 271a-271d are physically connected to each other by bridging elements, which are temporary metal elements for connection. 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 the embedded metal structure. In the fourth step, the bridging elements between connector components 271a-271d are eliminated by stamping to electrically separate them. Connector components 271a-271d are made of conductive metal. The injection-molded non-conductive body 290 is made of non-conductive plastic.

[0189] Each of the four connector components 271a-271d includes a contact arm 272 ( Figure 8cEach 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 region 272a.

[0190] The first connector component 271a, the second connector component 271b, and the third connector component 271c each include a second end of a contact arm 272, wherein a second electrical contact region 272b is adapted to make electrical contact with a non-conductive body 290 (see...). Figure 8a , Figure 6a , Figure 6b ) Supported by PCB-RU 243.

[0191] The first connector component 271a additionally includes Figure 8c The switch arm 273 and the first battery contact arm 274 are shown. The switch arm 273 is integrally formed in the first connector member 271a and is resiliently held relative to the rest of the connector member. The switch arm 273 includes a contact surface at its free end, which is adapted to establish contact with the pump unit printed circuit board PCB-PU 141 (see [reference] when the pump unit 100 is connected to the reservoir unit 200). Figure 17 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 button cell 244.

[0192] 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 including a second battery contact area 275a at its free end, the second battery contact area being adapted to be connected to the negative terminal of the button battery 244.

[0193] refer to Figures 8a-8c The nonconductive body 290 is described in detail below. The nonconductive 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 outside the base frame 241. A second electrical contact region 272b can be electrically connected to a storage unit printed circuit board (PCB-RU) 243 via a second opening 292 in the middle of the nonconductive body 290. A switch arm 273 also protrudes through the second opening 292. On the underside of the nonconductive body 290, a first battery contact arm 274 and a second battery contact arm 275 extend from the nonconductive 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.

[0194] like Figure 8a As depicted, a non-conductive body 290 is integrally formed as a linear guide for the bushing movement assembly 251, the linear guide including a flexible bushing retainer 253 and a rigid bushing retainer 254 (see [reference]). Figure 6a , Figure 6b , Figure 7 ).like 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 such that these retainers can be displaced between a retracted position and an extended position at a second end of the guide rails 295, 296. The lower guide rail 296 is adapted to guide a retraction control element for retracting the rigid sleeve retainer 254 such that the control element can be linearly displaced along the lower guide rail 296. An end stop surface 297 is arranged at a first end of the guide rails 295, 296, which restricts the linear movement of the flexible sleeve retainer 253 and the rigid sleeve retainer 254 and defines the initial or retracted position of the retainers 253, 254.

[0195] On the upper side, four retaining pins 293 are integrated into the non-conductive body 290. During assembly, the storage unit printed circuit board (RU-PCB) 243 is mounted on the four retaining pins 293 and secured by thermal riveting.

[0196] On the bottom side of the base frame 241, a non-conductive body 290 forms a battery opening 245 suitable for accommodating a button cell 244. Figure 7 (As shown in the diagram). A retaining element 246 for holding the battery 244 is arranged next to the battery opening 245. Figure 7 The retaining element 246 depicted is integrally formed in the non-conductive body 290. When the battery is inserted into the battery opening 245, the retaining element 246 is elastically deflected to facilitate battery insertion. If insertion is complete and the battery is placed in the battery opening 245, the retaining element 246 elastically moves backward and thus holds the battery 244 in the battery opening 245.

[0197] Figure 8 is a view of the nonconductive body 290 without the embedded conductive structure. Figure 8b In the view of conductive structures, such as those present after manufacturing has been completed ( ) and in the view of conductive structures that exist after manufacturing has been completed ( ) Figure 8c The base frame 241 is shown as a complete integral component in the diagram. Figure 8a ).like Figure 8b In the best visible part, the non-conductive body 290 further has a conical support pin 294 integrally formed on its upper side. The support pin 294 is adapted to pivotally support the insertion trigger 256.

[0198] 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 5As shown. If the pump unit 100 of the patch pump 1 is connected to the reservoir unit 200 via the bayonet connector 212a, then the connecting pin 142 of the pump unit 100 (see...) Figure 17 The contacts are pressed onto the first electrical contact area 272a of each of the contact arms 272. This establishes an electrical connection between the battery 244 of the storage unit 200 and the system control circuit 140 in the pump unit 100, and between the printed circuit board PCB-RU 243 of the storage unit and the system control circuit 140 in the pump unit 100.

[0199] The rechargeable battery 150 in the pump unit 100 can be charged by the button battery 244 in the storage unit 200 via an electrical connection between the pump unit 100 and the storage unit 200. The system control circuit 140 can control the heating element of the heater assembly on the PCB-RU 243 via an electrical connection between the PCB-RU 243 and the PCB-PU 141 in the pump unit 100. Similarly, the system control circuit can control other components on the PCB-RU 243 and / or acquire and process information about the state of the storage unit (such as the position of the needle assembly).

[0200] If the control circuit 140 of pump unit 100 sends a release command to PCB-RU 243 in the reservoir unit, the heating element of the heater assembly is activated. The heating element can then heat the fuse to cause it to blow, extend, or break. This can trigger the release of the biased insert trigger 256, which is supported by the support pin 294 (see...). Figure 6a and Figure 6b The device is pivotally supported. After the biased insertion trigger 256 is released, it can rotate away from the soft cannula holder 253 and the rigid cannula holder 254 and thus release them. After the holders 253 and 254 are released, they are moved to the extended position by the drive of the spring 252 guided by the rails 295 and 296, thereby inserting the soft and rigid cannulas into the user's skin. The insertion mechanism is described in detail in European patent application EP 18199475.7, which is incorporated herein by reference in its entirety.

[0201] Another set of preferred embodiments illustrates a third aspect of the invention. These are based on the embodiments described above. Figure 1 and Figure 2a , Figure 2b The wearable, semi-disposable patch pumps shown are described in further detail in the following paragraphs.

[0202] Figure 9aA 3D overview of a reservoir unit 200, including a reservoir or cartridge 222 and a filling port assembly 230, is shown, flipped from bottom to top, with the filling port located at the bottom in this example. The reservoir unit 200 includes a housing 211 formed by a bottom wall 211g, side walls 211h, and a top wall 211i. These walls define an internal space having openings for receiving the reservoir 222, in particular (among others). 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 the empty reservoir 222, which is closed by a plunger 221, see [link to diagram]. Figure 9b Details of the infill port assembly 230, housing, and reservoir 222 are presented in cross-sectional views for the following: - Figure 9b The assembled and fixed filler port assembly 230 in the middle, - Figure 10 The assembled but not yet fixed filler port assembly 230 in the middle. - Figure 11 The partially assembled filled port assembly without insert 235, and - Figure 12 The components of the housing and storage.

[0203] As in Figure 16 Exploded diagram and Figure 12 As best visible in cross-section, the housing 211 (preferably, the bottom wall 211g) includes a channel 211c adapted to receive a fill port assembly 230 formed by the insert 235 and the fill port seal 231. The channel 211c in the wall of the housing is surrounded by recessed or recessed sections (211d, 211f), and the channel 211c is aligned with the inlet 222a of the reservoir 222 to form an opening for receiving the fill port assembly. The housing 211 (preferably, the bottom wall 211g) includes at least one retaining pin 211e, which is preferably made of the same thermoplastic polymer as the housing.

[0204] 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 The stabilizing protrusion 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 to be applied 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).

[0205] Once the reservoir 222 has been 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 channel 211c in the housing. The stop in the housing may be formed by a protrusion or projection structure on the housing that abuts a portion of the reservoir.

[0206] To establish a fluid path from the outside to the reservoir inlet 222a and ensure fluid impermeability at a specified pressure (such as filling pressure), the filling port assembly includes at least one seal. Figure 16 In the illustrated embodiment, the fill port seal 231 is inserted into the channel 211c of the housing along the 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 connecting a flange 231a to a puncturable diaphragm 231c. Figure 14 The cylindrical section 231f of the filling port seal 231 is aligned with the axis of the inlet 222a of the reservoir when the filling port seal is inserted into the channel 211c. The flange 231a has a lateral dimension that fits tightly into the second recessed section 211d of the housing 211, while the pierceable diaphragm 231c fits tightly into the inlet 222a of the reservoir. The flange 231a is disc-shaped and has a conical opening 231g for access to a hole 231b terminating in the pierceable diaphragm 231c. The flange 231a fits into the disc-shaped second recessed section 211d in the housing. The cylindrical section 231f forms a hole 231b (see below) adapted to receive the sleeve 235c of the insert 235. The inlet of the filling port seal 231, starting from the flange, is conical and adapted to receive the insert 235c. Figure 13 The conical opening 235a of the insert is used. 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 is 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 conical 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 is in Figure 14 The middle part is shown as an integral component. The filling port seal is inserted into... Figure 15 The filling port seal 222g of the reservoir 222 shown is located in the cavity 222g. The filling port seal 231 is preferably made by two-component injection molding using a rigid thermoplastic 231d (such as PBT) and a soft elastomer 231e (such as polysiloxane liquid silicone (LSR) rubber).

[0207] exist Figure 11 The image shows a cross-section of the filler port seal 231, which has been inserted into the channel 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 image). 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 ) has an inlet 222a higher than the storage tank ( Figure 12 The inner and outer dimensions of the ) cause the distal end to be radially compressed as it enters the reservoir, thus at the filling port seal and the reservoir inlet 222a ( Figure 9b A second seal 239 is established between the inlet and the reservoir. The second seal 239 is radially oriented perpendicular to the axis of the reservoir inlet. Optionally, the distal end of the cylindrical section and / or the punctureable diaphragm 231c forms an axial seal with the surface of the reservoir inlet.

[0208] Figure 16 The exploded view shows how the filling port seal 231 and insert 235 are inserted into the channel 211c of the housing. Figure 10 A cross-section of the filler port assembly in this state before fixing is shown. The insert 235 is made of metal (stainless steel Cr-Ni steel, such as AISI 305) and includes a conical opening 235a (see also) that connects the base 235b to the sleeve 235c. Figure 13 A conical opening 235a fits into a cone formed of thermoplastic polymer 231d in the filling port seal 231. A sleeve 235c fits into the bore 231b of the seal for guiding a needle toward the puncturable diaphragm 231c. The base 235b of the insert includes a cut or opening 235d adapted to be received by the at least one retaining pin 211e extending from the housing, and the outer dimensions of the base thus fit into the first recessed section 211f of the housing. Figure 10 The insert 235 is secured to the housing by heat-riveting the retaining pin 211e, thus heating and deforming the retaining pin 211e. Figure 9b During the securing 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 partially compressed by a protruding edge 211j present in a second recessed section 211d in the housing. Figure 11Due to the compression of the flange, a first seal 238 is formed, axially displaced from the second seal 239. The first seal 238 and the second seal 239 are established by filling the port seal and bridging 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 Furthermore, the first seal 238 and the second seal 239 prevent external contaminants from entering the drug delivery device or the reservoir. Lateral movement of the reservoir 222 relative to the housing may also be restricted or even act as an impact absorber for the reservoir when the insert is secured to the housing. The reservoir inlet 222a is coupled to the housing via a fill port seal 231 and the insert 235, and the elastomeric material of the fill port seal 231 can act as a buffer or shock absorber between the rigid reservoir and the rigid housing.

[0209] exist Figure 16 The image shows a method for assembling a drug delivery device or a part thereof. A reservoir 222 is inserted into an opening in a housing along its longitudinal axis 222e. A plunger 221 may already be present in the reservoir. Figure 9b Alternatively, the reservoir may be inserted into the housing 211 after it has been positioned inside the housing 211. Preferably, the walls of the reservoir are reinforced with a plurality of reinforcing ribs 222f, which are also adapted to facilitate 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 channel 211c of the housing 211 when abutted by the reservoir. The inner surface of the housing may have longitudinal ridges for properly guiding the reservoir to its final position. In a subsequent step, the fill port seal 231 and the insert 235 are inserted into the channel 211c in the housing along an axis defined by the conical opening 235a of the insert (or the conical opening of the fill port seal). When the reservoir is in its final position, the axis defined by the conical opening 235a is preferably the same as the axis defined by the inlet 222a of the reservoir. During the insertion of the fill port seal, the distal end of the fill port seal enters the reservoir inlet 222a to establish a second seal 239. A first seal 238 is established during the securing of the insert (preferably by heat-riveting the retaining pin 211e). The mixing assembly 240 is also inserted into the housing before, during, or after insertion into the reservoir.

[0210] Another set of preferred embodiments illustrates a fourth aspect of the invention. These are based on the embodiments described above. Figure 1 and Figure 2a , Figure 2b The wearable, semi-disposable patch pumps shown are described in further detail in the following paragraphs.

[0211] The reservoir outlet seal is improved through a design that is particularly cost-effective to manufacture. This advantageous design has been described in the third aspect of the invention, wherein the reservoir outlet seal is combined with an improved filling port. Figure 18 An improved method of adding a reservoir outlet seal is shown. Figure 1 The storage unit, in which a portion of the housing has been removed, followed by a more detailed cross-sectional view of 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, the reservoir outlet sealing cavity 222d is sealed by inserting a substantially cylindrical reservoir outlet seal 223 made of a soft, fluid-impermeable but puncture-resistant material (such as silicone or any kind of rubber), thereby establishing a fluid-impermeable seal to the reservoir outlet sealing cavity 222d. In a separate manufacturing step, the reservoir outlet seal 223 is punctured by the input portion of the needle assembly. In the current example of the embodiment, the input portion of the needle assembly includes the input portion of a rigid sleeve 258. The result is a fluid-impermeable connection between the reservoir outlet and the needle assembly. Unlike diaphragm seals, the reservoir outlet seal and therefore the substantially cylindrical shape of the reservoir outlet sealing cavity provide significantly improved fluid impermeability, up to a specified filling pressure of 6 to 8 bar 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 completely different in shape, while maintaining a sufficiently large contact area between the reservoir outlet seal cavity and the reservoir outlet seal to provide the required fluid 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 arise by applying improvements to the outlet port seal to the reservoir outlet. All the features described according to aspect 4 of the invention (e.g., reducing the number of parts by applying a two-shot injection molding technique, or improving manufacturability by introducing an outlet port sealing plug cavity intersecting the outlet port opening) also produce variations of the embodiments described for the reservoir outlet.

[0212] Another set of preferred embodiments illustrates the fifth aspect of the invention. These are based on the embodiments described above. Figure 1 and Figure 2a , Figure 2b The wearable, semi-disposable patch pumps shown are described in further detail in the following paragraphs.

[0213] exist Figure 18 In, it is shown Figure 1The storage unit 200, in which a portion of the housing is removed, in particular exposing the rigid sleeve 258 and the flexible sleeve 259, which are the main components of the needle assembly in this embodiment. Figure 20 A cross-sectional view of the needle assembly at the interface between the rigid sleeve 258 and the flexible sleeve 259 is shown. The rigid sleeve 258 has a substantially tubular shape and is configured to slide axially within the flexible sleeve lumen 259a of the flexible sleeve while maintaining a fluid-impermeable sealing connection at the proximal inlet end of the flexible sleeve 259. To achieve fluid impermeability 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 modified 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 outside the needle assembly, or by thickening and / or deforming the flexible sleeve 259 by other means. Although the optimal location of the sleeve inlet seal portion 259b is precisely at the proximal inlet of the flexible sleeve 259, variations of this embodiment are possible, in which the flexible sleeve inlet seal portion 259b further faces the outlet end of the flexible sleeve 259. Further variations could make the flexible sleeve inlet seal a component separate from the flexible sleeve.

[0214] Another set of preferred embodiments illustrates the sixth aspect of the invention. These are based on the embodiments described above. Figure 1 and Figure 2a , Figure 2b The wearable, semi-disposable patch pumps shown are described in further detail in the following paragraphs.

[0215] The number of components at the interface is reduced by integrating one or more initially separate components into a single unit, thus improving the exit port. Figure 21aA schematic overview of the concept for application at the outlet port of a drug delivery device is given. The pump housing is shown having: a first housing component 213 surrounding an outlet port opening 213a; and two other housing components 214 connected to the first housing component 213 via housing seals 215. The combination of housing components (both the housing components of the pump unit and the housing components of the reservoir unit) forms a protective shell to protect the pump from mechanical damage, contamination, or other forms of environmental intrusion when equipped with a filling port and / or an outlet port and / or other sealing elements suitable for the intended use and connected to achieve said intended use. An outlet port assembly 261, including a rigid outlet port seal retainer 262 and a flexible 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 holder 262 not only secures the soft outlet port seal 263 in place to close the outlet port opening 213a, but also serves as a mechanical guide for the process of piercing the soft outlet port seal 263 with the output portion 260b of the needle assembly 260. The rigid outlet port seal holder 262 can have any shape suitable for this purpose. Examples of simple shapes include straight tubes, bends, cones, U-shaped grooves, or combinations of these shapes. At the piercing point (where the output portion 260b of the needle assembly 260 first contacts the soft outlet port seal 263), the rigid outlet port seal holder is tubular in shape, defining an outlet port channel 262a that is at least partially tubular and has an axis 262b.

[0216] Rigid outlet port seal retainer 262 is attached to one of the housing components (in Figure 21a The first housing component 213 is located in the middle. A soft outlet port seal 263 is installed at the outlet port opening 213a to seal the outlet port opening impermeably, while a rigid outlet port seal retainer 262 and the housing (in) are simultaneously present. Figure 21aA fluid-impermeable seal is established between the first housing component 213. This has the advantage that the connection between any housing component and the rigid outlet port seal retainer 262 does not need to be fluid-impermeable at all. The fluid impermeability requirement for the outlet port is entirely guaranteed by a soft outlet port seal, which can be designed to withstand the specified pressure (whether ambient pressure, choking pressure, or filling pressure). The soft outlet port seal 263 is made of a soft and elastic material, such as an elastomer (e.g., silicone rubber) or any other fluid-impermeable material that can be pierced by the output portion 260b of the needle assembly 260 and has sufficient elasticity to provide the surface pressure required to achieve a fluid-impermeable seal at the 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). A soft outlet port seal 263 is attached to a rigid outlet port seal holder 262 during manufacturing to form a fluid-impermeable connection, for example by double-shot injection molding, by press fitting, or by any other means of securing the seal for the intended purpose. The process of manufacturing the patch pump of this embodiment includes attaching the rigid outlet port seal holder to the housing, thereby closing the outlet port opening, and piercing the soft outlet port seal through the output portion 260b of the needle assembly 260. Since the output portion of the needle assembly is intended to be inserted into the patient's body for drug delivery, the output portion 260b will generally have a rigid and pointed end, such as the tip of a sharp needle or a rigid cannula. The order of the manufacturing steps is independent of the function of the outlet port, so the piercing of the outlet port seal 263 can occur before or after the outlet port assembly 261 is installed into the housing of the drug delivery device. Because the soft outlet port seal has two sealing functions, the step of attaching the rigid outlet port seal holder to the housing can be the same as the step of attaching the soft outlet port seal to the rigid outlet port seal holder.

[0217] The result is a patch pump that is easy to manufacture and has an integral outlet port seal that performs three sealing functions in one piece: sealing the housing to a rigid outlet port seal holder, sealing the output portion of the needle assembly to a rigid outlet port seal holder, and sealing the outlet port opening in a fluid-tight manner.

[0218] Further improvements to the outlet port concept of the present invention are 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 is... Figure 21b The schematic overview shows that the figure is for... Figure 21aThe same parts use the same numbers. A recess in the housing forms an outlet port chamber 213b, and the outlet port opening 213a is now located sufficiently within the encapsulation surface 1a of the pump to completely retain the output portion 260b of the needle assembly 260 within it. This arrangement offers the advantages of protecting the output portion of the needle assembly from unintentional physical contact, contamination, or damage to the environment, while simultaneously protecting the user and / or patient from unintentional contact with the output portion of the needle assembly and thus reducing the risk of injury from needle sticks.

[0219] The outlet port concept of the present invention yields at least three main groups of further improved embodiments. In the first group, the outlet port is improved by combining components of the outlet port assembly, the rigid outlet port seal retainer, and the flexible outlet port seal into a single integral component. Figure 22a , Figure 22b A preferred embodiment of the group is illustrated. 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 part (e.g., by two-shot injection molding), wherein a rigid outlet port seal retainer 262 and a soft outlet port seal 263 are injected in separate injections using different materials as defined by the design described above. Alternatively, the outlet port assembly 261 can be prefabricated by attaching the two parts (e.g., by gluing), by applying a press fit, or by any other technique resulting in a fluid-impermeable connection between the two parts. Figure 22a In the middle, the multiple sealing functions of the soft outlet port seal are clearly 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 use in the fully assembled state is shown. Figure 22a The patch pump in an embodiment of the outlet port assembly includes a needle assembly 260 having an output portion 260b.

[0220] In a second group 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 part. Figure 23a -c illustrates one of the many possible preferred embodiments of this group. Figure 23aThe first housing component 213 is shown in perspective, cut along the axis of the outlet port channel, with all soft components attached. The first housing component 213 is manufactured as a single integral part, for example, by two-shot injection molding using both soft and rigid materials. A rigid outlet port seal retainer 262 is an element of the first housing component 213, made of a rigid material, and manufactured, for example, in the first injection molding shot. The soft outlet port seal 263 is injected, for example, in the second injection molding shot using a soft material as described above. Materials can be selected to match the requirements of the drug delivery device, particularly fluid impermeability at the pressure specified for the outlet port. A particular advantage of this group 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 with other seals or functional elements on the same housing component that require soft material. Figure 23a and Figure 23b In this context, the multiple sealing functions of the flexible outlet port seal are clearly visible: the seal not only covers the open distal end of the outlet port channel 262a, but also includes a housing seal 215 within the housing designed for other purposes. The channel, made of a flexible material, can connect different sealing elements to improve manufacturability. Within the constraints of manufacturability, any type of housing component can be implemented, integrating the outlet port assembly with other housing elements as described herein. Figure 23b yes Figure 23a The cross-section of the outlet port assembly is shown to illustrate the shape of the soft outlet port seal 263 in the case of closing the distal end of the outlet port channel 262a. Figure 23c The use in the fully assembled state is shown. Figure 23a The patch pump in an embodiment of the outlet port assembly includes a needle assembly 260 having an output portion 260b.

[0221] In a third group of embodiments according to the sixth aspect of the invention, the outlet port is improved by keeping the flexible outlet port seal as its own component and by improving manufacturability (by introducing an outlet port sealing plug cavity configured to allow easy insertion of the flexible outlet port seal). Using this method, there is no need for an additional component as a rigid outlet port seal holder; the rigid outlet port seal holder is thus integrated into the housing component.

[0222] Figure 24a -d illustrates a preferred embodiment of this group. Figure 24aThe first housing component 213 is shown in perspective (left) and cross-section (right). The first housing component 213 is manufactured as a single integral part (e.g., by injection molding) and may also integrate other components (such as housing seal 215). A rigid outlet port seal holder 262 is an element of the first housing component 213 and is made of a rigid material. A flexible outlet port seal 263 is manufactured as a separate component, for example, by injection molding using a different mold. In this group of embodiments, the element of the first housing component corresponding to the rigid outlet port seal holder 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 of 10 degrees, most preferably between 45 and 90 degrees. Figure 24a This is illustrated by indicating the outlet port channel axis 262b and the outlet port sealing plug cavity axis 213d. In this embodiment, the outlet port sealing plug cavity 213c is open at its axial end. A soft outlet port seal can be easily inserted into the outlet port sealing plug cavity 213c along the outlet port sealing plug cavity 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 cavity while closing the outlet port opening 213a in a fully assembled state. Two additional figures are added to further illustrate the shape of the outlet port sealing plug cavity in this group of embodiments. Figure 24b This is a perspective view of the first housing component 213, in which the rigid outlet port seal retainer 262 is cut along the outlet port channel axis to show the shape of the outlet port seal plug cavity 213c. Figure 24c The same view is shown in the image, but with the soft outlet port seal inserted into the cavity of the rigid outlet port seal. Figure 24aIn the example of -d, both the outlet port sealing plug cavity 213c and the soft outlet port seal 263 are substantially cylindrical in shape, with one 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 side provides 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 with the output portion 260b of the needle assembly 260. An additional advantage of this angle between the axis of the outlet port sealing plug cavity and the axis of the outlet port channel is that when the output portion of the needle assembly pierces the soft outlet port seal, the soft outlet port seal is held in place by the rigid outlet port seal holder 262, with little or no shear or tensile force generated at the connection between the soft outlet port seal and the rigid outlet port seal holder. This again improves the seal to reliably meet the specified fluid impermeability requirements.

[0223] Figure 24d The use in the fully assembled state is shown. Figure 24a The patch pump in the embodiment of the -c outlet port assembly includes a needle assembly 260 having an output portion 260b.

[0224] Figure 25a -e illustrates something similar to Figure 24a Another preferred group of embodiments in the -d group of embodiments. Figure 25a The first housing component 213 is shown in perspective (left) and cross-section (right). As previously described, the first housing component 213 is manufactured as a single integral part (e.g., by injection molding) and may also integrate other components (such as the housing seal 215). The rigid outlet port seal retainer 262 is an element of the first housing component 213 and is made of a rigid material. The flexible outlet port seal 263 is manufactured as a separate component, for example, through injection molding using a different mold. Still like Figure 24a Similar to the group in -d, the element of the first housing component corresponding to the rigid outlet port seal holder 262 has an outlet port sealing plug cavity 213c, which in Figure 25aThe outlet port is filled with a soft outlet port seal 263. The outlet port sealing plug cavity with the outlet port sealing plug 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 and 90 degrees. However, in this group of embodiments, the outlet port seal is no longer a stop in a cylindrical shape, but may have any other shape suitable for being pressed into the outlet port sealing plug cavity through at least one open side. In this group of embodiments, the outlet port seal cavity axis no longer implies rotational symmetry, but rather indicates the path along which the soft outlet port seal is inserted into the rigid outlet port seal retainer. Pushing the wide seal a short distance into the cavity—which can be seen as the lateral assembly of the stop—is significantly easier than pushing a cylindrical seal axially, and results in a significant improvement in manufacturability. This group of embodiments has the additional advantage that the outlet port sealing plug cavity can be designed with a variety of shapes, particularly by adding a narrowing or flattening section around the open distal end of the outlet port channel to increase pressure and optimize fluid impermeability and permeability in that area without compromising ease of assembly during manufacturing. For lateral insertion, the shape of the outlet port seal 263 is preferably not as cylindrical as possible, but rather more like a buffer or tablet, such as... Figure 25d As shown in (left). Two more figures are added to further illustrate the shape of the outlet port sealing plug cavity in this embodiment group. Figure 25b This is a perspective view of the first housing component 213, in which the rigid outlet port seal retainer 262 is cut along the outlet port channel axis to show the shape of the outlet port seal plug cavity 213c. Figure 25c The same view is shown in the image, but with the soft outlet port seal inserted into the cavity of the rigid outlet port seal. Figure 25d It shows the insertion into Figure 25b The soft outlet port seal 263 is located before (left) and after (right) the outlet port sealing plug cavity 262. It is clearly visible that, in the arrangement as described, the soft outlet port seal 263 is elastically deformed and compressed due to the insertion, wherein the flat surface is at a substantially orthogonal angle when the output portion of the needle assembly pierces the seal.

[0225] Figure 25e The use in the fully assembled state is shown. Figure 25a In an embodiment of the -e outlet port assembly, the patch pump includes a needle assembly 260 having an output portion 260b.

[0226] Another set of preferred embodiments illustrates the seventh aspect of the invention. These are based on the embodiments described above. Figure 1 and Figure 2a , Figure 2b The wearable, semi-disposable patch pumps shown are described in further detail in the following paragraphs.

[0227] 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 a component of the patch pump housing 214, such as... Figure 26a As shown in -c. The outlet port cap 285 is configured to allow air to pass through while preventing or blocking any fluid (such as, for example, water or a fluidized drug) from entering or leaving the outlet port chamber 213b. In this case of the outlet port cap, the needle assembly 260 and reservoir 222 can be filled with a drug from the outside without any fluid coming into contact with the patient. During the filling of the reservoir 222 and / or the perfusion 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 forced through the outlet port cap and replaced by fluid. However, the fluid is blocked by the outlet port cap. This has two advantageous effects: first, as mentioned above, no drug 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 the filling pressure required for moving the plunger 221 and filling the reservoir can be applied to the fluid. By supporting the process of filling the reservoir and / or perfusion 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 cover is achieved using a priming membrane 285a, which is made of a semi-permeable material and preferably in sheet form, such as GoreTex® or a similar product. Because such membranes are often mechanically fragile, a membrane reinforcement structure 285b is permanently fixed to the priming membrane 285a, preferably in the area surrounding the outlet port chamber 213b, such as in… Figure 26a As shown in the basic embodiment. The membrane reinforcement structure can be, for example, a plastic ring, mesh, net, or sheet of textile material, which is strong enough to allow removal of the outlet port cap without damaging the cap, and is configured to allow fluid contact with the primer film. The membrane reinforcement structure 285b is removably attached to the housing component 214, for example by means of adhesive or double-sided tape. The double-sided tape can even be the same as the membrane reinforcement structure 285b, wherein a first side is permanently adhered to the primer film 285a, and a second side is removably adhered to the housing component 214. The presence of the membrane reinforcement structure is important for allowing the outlet port to be designed to achieve fluid impermeability at a specified minimum pressure (such as the filling pressure) while still ensuring ease of handling of the pump.

[0228] In this basic embodiment, the outlet port cap 285 further includes an outlet port cap liner 285c, which is permanently attached to the membrane reinforcement structure 285b but not to the housing component 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 infusion of the patch pump. Since filling and infusion are not functions unique to patch pumps, the concept of the outlet port cap can be advantageously applied to all types of drug delivery devices.

[0229] To achieve optimal accuracy and reliability, it is particularly important that the patch pump ensures good adhesion of the area surrounding the output portion of the needle assembly to the patient's body during drug delivery (ideally with a fluid-impermeable connection). The outlet port concept with an outlet port cap is further improved by bringing the edge of the adhesive layer providing this fluid-impermeable connection closer to the outlet port. This is achieved by integrating the outlet port cap into the adhesive patch assembly. Figure 26b A preferred example of this embodiment is shown. The outlet port cap 285 still includes a primer film 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 component 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 in such a way that a fluid-impermeable connection is formed between the housing 214 and the outlet port cap 285 as long as the outlet port cap 285 is attached to the housing. A very simple example is a plastic ring integrated into or permanently attached to the housing component 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 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 primer membrane 285a is permanently fixed to the membrane reinforcement structure 285b. This arrangement is easy to manufacture and can be optimized to achieve fluid impermeability at a specified minimum pressure by removing the dedicated outlet port cap liner (285c, see...). Figure 26a This provides further cost advantages and optimal ease of use. By removing the adhesive release liner 280b from the adhesive layer 280a, the outlet port cover 285 can be easily removed from the outlet port chamber 213b—a task that the user must do anyway to attach the patch pump to the patient's body. Figure 26cA possible embodiment of an adhesive patch assembly 280 combined with an outlet port cap 285 as described is shown. A base coat 285a is mounted on an adhesive release liner 280b using a double-sided adhesive ring, which also acts as a membrane reinforcement structure 285b. An adhesive mounting strip 280d is used to permanently attach the adhesive patch assembly 280 to a base plate 211a (not shown) at the bottom of the reservoir unit. At least a plurality of adhesive cuts 280c are introduced 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 to a location for drug delivery, or pressure compensation.

[0230] 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 outlet port cover attachment may be designed to detach at low fluid pressures, thereby intentionally allowing leakage to indicate to the user that filling of the reservoir has been successfully completed, or to indicate to the user that the maximum pressure has been exceeded.

[0231] Another set of preferred embodiments illustrates the eighth aspect of the invention. These are based on the embodiments described above. Figure 1 and Figure 2a , Figure 2b The wearable, semi-disposable patch pumps shown are described in further detail in the following paragraphs.

[0232] The patch pump is further improved by introducing numerous ventilation channels at the interface between the patch pump and the patient's body. These ventilation channels allow air and moisture to exit through the interface and enter 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 ventilation channels are known, their combination with other aspects of the invention produces… Figure 27 The novel solution is shown. As described above, it is advantageous for the patch pump to ensure good attachment of the area surrounding the output portion of the needle assembly to the patient's body during drug delivery (ideally with a fluid-impermeable connection). Therefore, in embodiments of the invention, the ventilation channel is not connected to the outlet port chamber, but begins only at a distance that is large enough for the adhesive patch assembly to ensure this fluid-impermeable connection, but small enough to improve adhesion in that area of ​​the adhesive patch assembly. A preferred distance range is 1 mm to 20 mm, most preferably 5 mm to 10 mm. Figure 27In a preferred embodiment, the ventilation channel is implemented as a ventilation recess 212f in the base plate 211a of the reservoir unit 200. This example of the embodiment also includes a membrane support structure 212e. Therefore, an adhesive layer covers the entire base plate 211a, including the base plate extension 212c, and has cutouts for an outlet port and for the membrane support structure 212e. Figure 27 Clearly visible is that the ventilation groove 212f is arranged at a distance from the edge of the membrane support structure 212e. With the adhesive patch assembly (not shown) mounted on the base plate 211a, the ventilation groove is covered by the adhesive patch assembly, thus forming a ventilation channel that allows air and moisture to pass from the closed inner end 212g of the ventilation groove 212f to the open outer end 212h of the ventilation groove 212f and exit therein into the environment outside the patch pump. Figure 27 It is also clearly visible that these ventilation channels are not connected to the outlet port chamber 213b. Clearly, the shape or number of ventilation channels is not important to their intended function. Although Figure 27 In the embodiments, the ventilation channels are implemented as two substantially straight semi-cylinders, but they may have any other geometry, size, arrangement, or be placed on the base plate 211a or the base plate extension 212c, as long as they are not connected to the outlet port chamber 213b and at least one open end faces the environment outside the pump.

[0233] The result is a patch pump that provides improved ventilation at the interface between the pump's base and the patient's body, while still allowing for 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 impermeability at the minimum fluid pressure specified for the interface.

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

[0235] 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 liquid fluids are blocked from passing through the interface. By doing so, the pressure values ​​inside and outside the patch pump are maintained equal, thereby preventing pressure conditions (e.g., the pressure gradient inside the reservoir and within the fluid path) from being affected by external pressure fluctuations. This improves the drug delivery accuracy of the patch pump and thus enhances the accuracy, reliability, and safety of drug delivery. While similar ventilation components are known, combinations with other aspects of the invention result in improved embodiments, which... Figure 28 As shown in Figure 33, the pressure outside the patch pump can vary with atmospheric air pressure or due to pressure changes within the compartment (e.g., an aircraft). The pressure inside the patch pump can vary due to volume changes (i.e., during filling or administration and / or due to temperature changes). As previously mentioned, it is advantageous for patch pumps 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.

[0236] Figure 28 This is 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 is covered on its bottom side with an adhesive release liner 280b. Figure 29 The bottom-up perspective view shows the patch pump 1 with the adhesive layer 280a of the adhesive release liner 280b exposed on the bottom side of the patch pump, revealing the adhesive patch assembly 280. The fill port assembly 230 and the outlet port assembly 261 are partially visible through the adhesive cutout 280c. Figure 30An exploded perspective view of an embodiment of a ventilation assembly 201 including a reservoir unit housing 211 is shown, the reservoir unit housing forming a bottom wall 211g having a base plate 211a on its bottom outer side. A recessed surface 211o is formed in the bottom wall 211g, providing dimensions for a cavity 211q. The cavity 211q is interconnected with or integrated with a channel 211c that receives a component of a filling port assembly 230. Thus, the cavity 211q communicates with the environment or external fluids of the patch pump 1 through the channel 211c and the opening 211p. A through-hole 211n pierces the bottom wall 211g in the recessed surface 211o. The exploded perspective view further shows, along an axis perpendicular to the base plate 211a and extending from the top to the bottom of the reservoir housing 211: an annular membrane adhesive patch 203, a circular semi-permeable pressure compensation membrane 216, a spacer structure 204, and an adhesive mounting strip 280d with an adhesive cutout 280c. In its assembled state, the improved ventilation assembly is composed and facilitated by its components as follows: air contained in the compartment or internal volume 202 of the reservoir unit 200 is connected through a through-hole 211n to the top side of a pressure compensation membrane 216, wherein the pressure compensation membrane 216 is sealed to a recessed surface 211o by an annular membrane adhesive patch 203, which restricts a first portion of the volume of the 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 the cavity 211q. The second portion of the cavity 211q is ventilated from the environment via an opening 211p through a channel 211c, wherein an adhesive layer 280a and an adhesive mounting strip 280d form the bottom boundary of the cavity 211q and the channel 211c. A permeable spacer structure 204 is located in the cavity 211q between the bottom side of the pressure compensation membrane 216 and the top side of the adhesive layer 280. Due to its rigid yet permeable form, the permeable spacer structure 204 prevents the adhesive layer 280a from sealing off the pressure compensation membrane 216 nearby. 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 A bottom-up perspective view shows a patch pump 1 (adhesive patch assembly 280 not shown) with a bottom wall 211g and a recessed surface 211o exposed on its bottom side. 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 A cross-sectional perspective view taken from bottom to top is shown; the adhesive patch assembly 280 and pressure compensation diaphragm 216 are not shown. This cross-sectional view reveals the internal volume 202 of the reservoir 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 base plate 211a with a recessed surface 211o is formed on the outer side of the bottom wall 211g, at which a through-hole 211 pierces the bottom wall 211g, thereby fluidly connecting the internal volume 202 to a first portion of the volume of the cavity 211q. The cavity 211q integrates a channel 211c and accommodates components of the filling port assembly 230 and leads to an opening 211p. Figure 33a A perspective side view of patch pump 1 is shown, and Figure 33b Show Figure 33a Magnified details. The reservoir unit 200, including the adhesive patch assembly 280, is visible. The opening 211p is defined by the recessed surface 211o and the top side of the patch assembly 280.

[0237] Another set of preferred embodiments illustrates the tenth aspect of the invention. They are based on the foregoing description of... Figure 1 and Figure 2a , Figure 2b The wearable, semi-disposable patch pumps shown are described in further detail in the following paragraphs. The combination of the advantages of individual point support with other aspects of the invention results in improved embodiments, as shown in Figures 34 to 35. Figure 39 As shown in the example.

[0238] The patch pump is improved by introducing a bearing assembly 101 in the drive mechanism 120 of the pump unit 100, the bearing assembly including a bearing element 126 that provides a support point 126a for a support surface 125b at the interface between a threaded rod 125 and a base sleeve 127.

[0239] Figure 34a A perspective top view depicting a pump unit 100 having a pump unit housing 102 and a cover 102a. A plunger rod 122 is guided within the cover 102a. Figure 34b Depicting Figure 34aAn enlarged sectional view AA through the pump unit 100 is specified in the figure, and a view of the components of the bearing assembly 101 is also given. This sectional view extends along a longitudinal axis 121 defined by a hollow plunger rod 122 having internal threads 122a and a rotatable threaded rod 125 having external threads 125c. The plunger rod 122 is rotatably fixed and can be axially movably guided within the cover 102a along the longitudinal axis 121. The threaded rod 125 is fixedly connected to the proximal end of the drive sleeve 128, and the proximal end of the threaded rod 125 forms a pivot 125a with a support surface 125b on its proximal end. A drive sleeve 128, together with a threaded rod 125, pivots about a longitudinal axis 121 within a base sleeve 127, wherein a ball bearing 129 is received between the distal end of the drive sleeve 128 and a cover 102a, and wherein the proximal end of the drive sleeve 128 is rotatably mounted via a sliding bearing 127a formed between a distal section of a mounting hole 127a in the end wall 127b of the base sleeve 127 and a pivot 125a of the threaded rod 125. The proximal end face of the pivot 125a forms a support surface 125b. A spherical bearing element 126 is axially fixedly received in the proximal end of the mounting hole 127a, the proximal end being adjacent to the support surface 125b, thereby forming a support point 126a on the longitudinal axis 121. A cavity 127c formed between the support surface 125b and the bearing element 126 may be filled with a lubricant 127d. On a section of the outer surface of the drive sleeve 128, a drive pinion 128a is formed or mounted. The base sleeve 127 and the cover 102a, and thus 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 perspective side view of a pump unit 100 having a pump unit housing 102 is depicted. Figure 36 Depicting Figure 35 A rotated perspective side 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 perspective side view of the bearing assembly 101 is depicted, in which the distal end face of the drive sleeve 128 (coaxially surrounding the plunger rod 122), the ball bearing 129, and the base sleeve 127 are visible. Figure 38 A perspective side view depicting the bearing assembly 101 (with the pump unit housing 102 and base sleeve 127 removed) is shown as a subset of the drive mechanism 120. Coaxially around the longitudinal axis 121, the pivot 125a, the spherical bearing element 126, the plunger rod 122, the drive sleeve 128 with a drive pinion 128a, and the ball bearing 129 are visible. Figure 39 A cross-sectional perspective view of the base sleeve 127 is shown. A blind mounting hole 127a is visible at the center of the end wall 127b of the base sleeve 127.

[0240] Although the invention has been described in detail with reference to the accompanying drawings and the foregoing description, such description is to be considered illustrative or exemplary rather than limiting. By studying the drawings, the disclosure, and the appended claims, those skilled in the art can understand and implement variations of the disclosed embodiments in practicing the claimed invention. Given the nature of the invention and its many aspects contributing to its overall optimal state, it will be apparent to those skilled in the art that improvements described in various choices and / or combinations may be applied for better clarity. For example, a solution provided for an improved outlet port seal may be well used to improve a filling port or any other seal in a drug delivery device. A filling port assembly may be combined with an outlet port assembly to further optimize the pump. 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. The mere fact that certain elements or steps are recited in different claims does not indicate that a combination of such elements or steps cannot be beneficial; specifically, any further meaningful combination of claims, in addition to the actual claim dependencies, should be considered disclosed.

[0241] List of reference numerals 1. Patch Pump 1a Encapsulation surface 100 pump units 101 Bearing Assembly 102 Pump Unit Housing 102a cover 102b Seal 113 Locking mechanism 113a Locking Spring 114 Open side 120 drive mechanism 121 Longitudinal axis 122 plunger rod 122a Internal Thread 123 Plunger Cap 125 threaded rod 125a Pivot 125b Support Surface 125c external thread 126 Bearing Components 126a Support Point 127 Base Sleeve 127a Mounting Hole 127b end wall 127c cavity 127d Lubricating Material 127e sliding bearing 128 drive sleeve 128a drive pinion 129 ball bearing 140 System Control Circuit 141 Printed Circuit Board, PCB-PU 142 Connecting pin 150 rechargeable batteries 151 Battery Contact 200 storage units 201 Ventilation Components 202 Internal volume 203 Membrane Adhesive Patch 204 Spacer Structure 211 Storage unit housing 211a base plate 211b wall 211c channel 211d First Depression Section 211e Fixed pin 211f Second Depression Section 211g bottom wall 211h sidewall 211i Top Wall 211j Protruding edge 211k stable recess 211m incision 211n through hole 211o concave surface 211p Opening 211q Cavity 212a Bayonet connector 212b Rotation axis 212c Base plate extension 212d locking structure 212e Membrane Support Structure 212f Ventilation recess 212g inner end 212h external terminal 213 First housing component 213a Outlet port opening 213b Outlet port chamber 213c Outlet port sealing plug cavity 213d Outlet port sealing plug cavity axis 214 Housing components 215 Housing seal 216 Pressure Compensation Membrane 221 Plunger 222 storage 222a Storage Inlet 222b Stable protrusion 222c Storage outlet 222d Container 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 Hole 231c Punctureable 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 cannula lumen 259b Flexible sleeve seal, input 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 Flexible outlet port seal 270 Connector Structure 271a-271d Connector Components 272 Contact Arm 272a First electrical contact area 272b Second electrical contact area 273 Switch 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 Primer Film 285b membrane-reinforced structure 285c Export Port Cover Liner 290 Non-conductive material 291 First Opening 292 Second opening 293 Fixed pin 294 Support pin 295 Upper guide rail 296 Lower guide rail 297 End stop surface 300 patients

Claims

1. A bearing assembly (101) for a pump unit (100) of a drug delivery device, the bearing assembly (101) comprising: - A hollow plunger rod (122) having a proximal end and a distal end, the proximal end and the distal end defining a central longitudinal axis (121), and the hollow plunger rod having an internal thread (122a). - A threaded rod (125) rotatable about the longitudinal axis (121), the threaded rod having an external thread (125c) and forming a pivot (125a) on its proximal section, the external thread (125c) being configured to engage the internal thread (122a) of the plunger rod (122). - A drive sleeve (128) that can be rotatably and securely connected to the threaded rod (125). - Base sleeve (127), the base sleeve having an end wall (127b) on its proximal side. - Bearing components (126); The base sleeve (127) forms a mounting hole (127a) in the proximal wall (127b) around the longitudinal axis (121) to axially accommodate the bearing element (126) and the pivot (125a), wherein the bearing element (126) is arranged adjacent to the pivot (125a) on the proximal side.

2. The bearing assembly (101) for a pump unit (100) of a drug delivery device according to claim 1, wherein, The mounting hole (127a) is formed as a blind hole in the distal side of the end wall (127b) or as a through hole, the through hole having an inner annular protruding edge or flange on the proximal section of the mounting hole (127a).

3. The bearing assembly (101) for a pump unit (100) of a drug delivery device according to claim 1, wherein, The distal section of the mounting hole (127a) and the pivot (125a) form a sliding bearing (127e).

4. The bearing assembly (101) for a pump unit (100) of a drug delivery device according to claim 1, wherein, The bearing element (126) has a convex surface on its distal side.

5. The bearing assembly (101) for a pump unit (100) of a drug delivery device according to claim 1, wherein, The bearing element (126) is a ball.

6. The bearing assembly (101) for a pump unit (100) of a drug delivery device according to claim 1, wherein, The bearing element (126) is made of a metal or ceramic compound.

7. The bearing assembly (101) for a pump unit (100) of a drug delivery device according to claim 1, wherein, The bearing element (126) is made of medium alloy cold work tool steel.

8. The bearing assembly (101) for a pump unit (100) of a drug delivery device according to claim 1, wherein, The threaded rod (125) is made of a metal alloy.

9. The bearing assembly (101) for a pump unit (100) of a drug delivery device according to claim 1, wherein, The base sleeve (127) is made of glass fiber reinforced polyamide or a polymer blend containing polycarbonate (PC) and acrylonitrile / butadiene / styrene (ABS).

10. The bearing assembly (101) for a pump unit (100) of a drug delivery device according to claim 1, wherein, The proximal end face of the pivot (125a) forms a flat or convex support surface (125b) to contact the support point (126a) on the distal side of the bearing element (126) at the longitudinal axis (121).

11. The bearing assembly (101) for a pump unit (100) of a drug delivery device according to claim 1, wherein, The cavity (127c) defined in the mounting hole (127a) by the bearing element (126) and the support surface (125b) of the pivot (125a) contains a lubricating substance (127d).

12. The bearing assembly (101) for a pump unit (100) of a drug delivery device according to claim 1, wherein, The drive sleeve (128) has a drive pinion (128a) formed on its outer surface to introduce a drive torque relative to the longitudinal axis (121).

13. The bearing assembly (101) for a pump unit (100) of a drug delivery device according to claim 1, wherein, The cap (102a) is configured to close the distal side of the base sleeve (127) and is configured to guide the plunger rod (122) along the longitudinal axis (121).

14. The bearing assembly (101) for a pump unit (100) of a drug delivery device according to claim 1, wherein, The ball bearing (129) is housed between the cover (102a) and the drive sleeve (128).

15. A drug delivery device pump unit (100) comprising a pump unit housing (102) adapted to accommodate a bearing assembly (101) according to any one of the preceding claims.

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