Wearable drug delivery device

Abstract

The present invention relates to an improved filling port for filling a liquid medicament into a reservoir of a drug delivery device, wherein the reservoir is located inside the drug delivery device, an insert is fixed in a channel of a wall of the drug delivery device, and a pierceable filling port seal is sandwiched between the insert and both the housing and the reservoir of the drug delivery device to provide a fluid-tight seal between the reservoir and the housing.

Description

Technical Field

[0001] The present invention relates to a drug delivery device, in particular to a wearable patch pump for delivering a fluid medicament subcutaneously from a reservoir. Advantageous variants of the invention include an improved design or an improved method of manufacturing a drug delivery device. Background Art

[0002] There are many diseases that require conventional treatment by subcutaneous administration of medicaments, and many drug delivery devices have been developed to support patients in accurately and controllably delivering a certain amount of drugs during self-administration. Delivery devices include drug delivery devices that are removed from the injection site after each drug event or drug delivery process, and infusion devices with cannulas or needles that remain in the patient's skin for a long time. As an example, diabetes can be treated by the patient's own administration of insulin with the help of a multi-variable dose insulin injection pen or infusion pump. Alternatively, a patch injector, a wearable injector, or a wearable pump is patched or adhered to the patient's skin.

[0003] In a departure from the classical syringe, increasingly sophisticated devices have been designed to support different treatments, ensure safety and reliability, and improve ease of use to the point where patients can apply the medication themselves, minimizing time-consuming and expensive intervention by trained medical personnel. Examples of drug delivery devices suitable for self-treatment include injection pens, autoinjectors, portable infusion pumps, and wearable patch pumps. Despite the technological sophistication, an important requirement is to keep manufacturing and device costs as low as possible.

[0004] The common point of all devices for subcutaneous drug delivery is a reservoir for storing fluid medicaments and a fluid path for taking the drug out of the device and into the patient's subcutaneous tissue. The fluid impermeability of the fluid path is a basic requirement to ensure the safety and accuracy of delivery. Longer-term infusion mode and reliable system monitoring function are particularly dependent on the controlled fluid pressure along the fluid path. Although this is quite easy to achieve for classic syringes, it becomes a challenge as the complexity of the device increases. The design for self-administration further increases the requirements, which means using in a non-sterile environment, by people without medical training, or even by people with reduced visual 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 bring the drug from the pump into the patient's body.

[0006] An important step towards ease of use is to omit the drug delivery device and design 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 has the following: a housing with a reservoir for accommodating the drug; a cannula for guiding the drug into the patient's body; and a needle assembly for establishing a fluid-tight connection between the reservoir and the cannula. In order to obtain 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 compact and fluid-tight designs, the reservoir is usually built into the housing and needs to be filled from the outside before use. Many sealing components are required to ensure the fluid-tight design of the fluid path and the housing. For the filling port (at the filling port, the drug is brought into the reservoir) and the outlet port (at the outlet port, the cannula passes from the inside of the housing to the outside of the housing for drug delivery), special solutions are required. Wearability requires a compact overall design for the patch pump, which further increases the complexity of design and manufacturing. 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 ease of use and at a potentially low cost. Among other applications, they are the preferred solution for intermittent delivery of insulin 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-tight and robust design and that can be manufactured at low cost. In order to arrive at an optimal solution, all involved components must be designed accordingly.

[0008] US 7,303,549 B2 describes a completely disposable patch pump for transdermal fluid delivery. Although this concept includes an automatic insertion mechanism for the injection needle and provides a high level of ease of use, the lack of reusable parts presents the disadvantage of generating large amounts of waste and increasing the cost of treatment.

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

[0010] US 9,993,595 B2 describes another example of a modular patch pump in 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 material used for such wearable drug delivery devices is typically plastic due to its favorable manufacturing properties and its low density.

[0012] In other technical fields, different types of materials are often combined to benefit from the advantageous properties of the different materials. For example, US 5,597,990 B1 discloses an electrical switch which is integrated in a switch box and is designed to detect the presence of an electronic memory card in a card reader device. The housing of the switch box carries two fixed electrical contact elements which are 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 box to form a terminal for connection and soldering on a printed circuit board. The contact element is partially embedded in the overmolded plastic housing of the switch box.

[0013] In WO03103763 a patch injection device is disclosed which comprises an external housing for accommodating a reservoir. The reservoir is closed by a needle-insertable septum and can be filled by an external filling device using a filling port located in the housing.

[0014] In WO2017120251, a filling aid for a patch pump is disclosed, 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 septum and can be filled through a filling port located in the housing of the pump. The external filling aid includes a conical opening for guiding the needle of an external filling device. It is the presence of the filling aid that proves that the filling port is cumbersome to use in terms of being integrated in the patch pump.

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

[0016] US 6,699,218 B2 describes a patch pump having a soft cannula and a rigid cannula that is axially slidably movable in the soft cannula 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 cannulae to achieve fluid impermeability at a specified occlusion pressure. Fluid impermeability at a specified occlusion pressure is necessary for reliable detection of blockages in the fluid path.

[0017] The most common method of sealing the outlet port is by piercing the septum. One such 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 extending this basic concept and by optimizing the outlet port assembly for the specific requirements of the application.

[0018] An outlet port assembly for a patch pump having a flexible cannula and an insertion mechanism is disclosed in EP 1682203 B1. The assembly as disclosed comprises many sealing components, making it more costly and less optimal for manufacturing.

[0019] US 7,771,412 B2 describes an environmental seal for a fluid delivery device in which the outlet port is designed as a cap comprising two distinct parts and mounted into a housing. Although two-shot molding is mentioned as a way to improve manufacturability and reduce costs, the proposed outlet port is rather complex. The soft plug remains in the interior of the cap and is not arranged in a way that allows combination with other functions for further optimization.

[0020] In a patch pump with an automatic insertion mechanism, a fluid connection between the output of the reservoir and the cannula is established when the pump is manufactured. This open path may affect the accuracy of drug delivery or also affect the function of the filling process. Therefore, it is desirable to close the path until the drug delivery is intended to begin. One purpose 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 semipermeable outlet plug to support filling and priming of a patch pump with a needle insertion mechanism. The plug may be a sheet material that is attached to an adhesive release liner of an adhesive patch. Although simple, this concept tends to tear the semipermeable sheet material during removal of the plug and requires a solution with improved reliability and thus improved ease of use.

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

[0023] EP 3251585 A1 discloses an adhesive patch assembly for a patch pump, the patch assembly including a structure to improve the reliability of the connection with the patient's body by letting air and moisture pass from the skin surface to the environment. This concept can also be expanded and combined with other functions to achieve the best state of reliability and ease of use. Summary of the invention

[0024] An 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 present invention contribute to the overall optimization. All of them can be applied to a variety of drug delivery devices, such as pen injectors, patch injectors, mobile pumps or patch pumps.

[0025] An additional object is to provide an improved assembly method for a drug delivery device as disclosed in the corresponding claims.

[0026] definition

[0027] The terms "substance", "drug", "medicament" and "drug" include any flowable medical preparation suitable for controlled administration by 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 medicament may be a composition comprising a single active ingredient, or a premixed or co-formulated composition with more than one active ingredient present in a single container. Drugs include drugs such as peptides (e.g., insulin, insulin-containing drugs, GLP-1-containing drugs or derived or similar preparations), proteins and hormones, active ingredients derived from or harvested from biological sources, hormone- or gene-based active ingredients, nutritional preparations, enzymes and other substances in both solid (suspended) or liquid form, and also polysaccharides, vaccines, DNA, RNA, oligonucleotides, antibodies or antibody portions, and also suitable alkaline, auxiliary and carrier substances.

[0028] The distal end or distal direction is defined by the direction of the needle configured to penetrate the patient's skin. For an injection pen, this may be the injection needle, and the pen's holding needle or the end configured to hold the needle is the distal end. For an infusion device, the distal end and the distal direction are toward the needle configured to penetrate the patient's skin, which may be along the axis of the device or oblique or perpendicular to the axis of the device. The distal direction in an infusion device means the direction of the flow of the medicament toward the insertion needle. The proximal direction or proximal end is opposite to the distal direction or distal end.

[0029] The term "injection system" or "syringe" refers to a device that is removed from the injection site after each drug event or drug delivery process, while the term "infusion system" refers to a device with a cannula or needle that remains in the patient's skin for a long period of time (e.g., several hours). If not explicitly mentioned otherwise, the term "pump" refers to an infusion system, which in the context of the present invention typically refers to a patch pump.

[0030] 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, "a seal" or "a projection" does not exclude the fact that there may be two "seals" or "projections" that functionally or structurally achieve the purpose of "a seal" or "a projection".

[0031] Description of the Invention

[0032] In a first aspect of the invention, a modular concept for a semi-disposable patch pump is introduced, providing an optimal compromise between ease of use and reuse of components. This is achieved by reducing the number of components that the user has to 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.

[0033] The reservoir unit includes a reservoir unit housing and a base plate mounted on an adhesive patch (wherein the base plate is attached to the bottom of the reservoir unit housing or integrated into the bottom of the reservoir unit housing), and includes all parts intended for disposable use, particularly all parts in contact with the drug and the adhesive patch. The drug-bearing component will generally include the following: a reservoir having a reservoir outlet; a pump mechanism; and a needle assembly connected to the outlet of the reservoir to transport the drug from the reservoir to the patient's body. In order to obtain optimal ease of use, the reservoir unit further includes an inserter assembly, which includes an automatic insertion mechanism for inserting the needle into the patient's body without the user applying any force. The pump mechanism can, for example, include a plunger, which is movably mounted in the reservoir, thereby allowing the drug to be pressed out of the reservoir through the reservoir outlet by moving the plunger. Any kind of energy can be used to drive the automatic insertion mechanism: energy stored in the reservoir unit (such as a preloaded insertion spring), or energy from the outside (such as rotation generated by the pump unit). This also includes the possibility of using the same drive unit to drive or release the automatic inserter as used to drive the pump mechanism. 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 device to drive the pump mechanism in the reservoir unit; acoustic and / or visual and / or tactile elements to interact with the user; a communication unit to send data to other system components and / or receive data from other system components; and a control unit to control the device. In embodiments where the pump mechanism is a plunger movably mounted in the reservoir, the drive device can be, for example, a combination of a motor, gearing, and a coupling to a threaded rod that cooperates with the plunger rod.

[0034] The pump unit is further configured to be releasably attached to the reservoir unit. An important aspect of the present invention is how the reservoir unit and the pump unit are mechanically connected. The connection must be safe and reliable, allowing easy separation of the pump unit and the reservoir unit to replace disposable parts, while ensuring optimal safety and reliability when the pump unit is accidentally separated or removed during normal use.

[0035] With the two units connected, the patch pump is preferably formed into a substantially edgeless shape for optimal wearability and to avoid accidental removal of the patch pump from the patient's body. The outer shape that encapsulates the pump components during normal use also contributes to avoiding accidental removal of the pump unit from the reservoir unit. Still with the goal of achieving optimal ease of use, the mechanical interface between the reservoir unit and the pump unit preferably includes a bayonet coupling, in which no button needs to be pressed or a slider needs to be moved to release the connection, while still ensuring a mechanical connection with optimal rigidity and minimal axial play as required for accurate and reliable drug delivery.

[0036] 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 closing the substantially edgeless encapsulating outer surface of the pump. The closing movement of the reservoir unit is substantially a rotation about the axis defined by the bayonet connection. To open the bayonet, the user will pull on the side of the reusable unit facing away from the axis of rotation of the bayonet, at which side the pump unit is lifted out of the plane of the base plate to release the pump unit.

[0037] Although the concept of a semi-disposable patch pump as described in the present invention includes any kind of locking mechanism for the bayonet connection, a mechanism that allows the same processing step to unlock and open the connection is particularly easy to use and is therefore preferred. Examples of such embodiments are a mechanical latch that snaps in and out by a simple push and pull, a magnetic lock, or a pair of Velcro® strips.

[0038] Although the encapsulated outer shape of the patch pump is optimized for wearability, unlocking and removing the pump unit may still occur if the patient's body part to which the pump is attached accidentally brushes the edge. The 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 be opened, and the pump unit can be wiped off the patient's body (brushed off). In order to avoid such accidental removal, an improved embodiment of the patch pump includes a base plate, which extends between the open side and the bayonet axis from the bottom of the reservoir unit housing in the direction of the pump unit. Although this extended base plate effectively reduces the risk of accidentally removing the pump unit from the reservoir unit, it can make it more difficult for the patient to intentionally remove the pump unit. Therefore, a further improvement of the patch pump according to the present invention is a cutout at the edge of the base plate. The effect of the cutout is that the patient's finger can slide at least partially under the pump unit on the open side of the pump, while the longer edge remains outside. To achieve this, the incision 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.

[0039] The patch pump according to the present invention reduces to a minimum the number of handling steps required to apply the pump, while also minimizing the waste generated by the treatment.Despite the ease of use of the patch pump, additional features ensure that the patch pump is safe to use.

[0040] In a second aspect of the invention, a concept for a compact design of a drug delivery device is introduced.This object is achieved by a drug delivery device having a reservoir for containing a liquid drug, a needle assembly for delivering the drug, and a base frame.

[0041] According to a second aspect of the invention, a drug delivery device comprises a base frame comprising a conductive connector structure comprising an electrical contact area for establishing an electrical connection between the base frame and an external device. The base frame further comprises a non-conductive body injection molded around the connector structure so that the electrical contact area can be contacted by the external device from outside the non-conductive body. The base frame can further be integrated into a housing of the drug delivery device or form part of a housing of the drug delivery device.

[0042] The current aspect of the invention may further include a base frame itself for a drug delivery device as described in the previous paragraph, the base frame comprising: a conductive connector structure, which includes an electrical contact area for establishing an electrical connection; and a non-conductive body, which is injection molded around the connector structure so 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 the needle assembly, and the guide member is combined with the non-conductive body to form an integral component.

[0043] According to prior art methods, the different electrical contact elements and the support for holding the contact elements in place inside the drug delivery device are individually mechanically connected to each other, for example by heat riveting, by riveting, by plugging or pressing into a socket, or by using a snap-lock connection. The different electrical elements are complex to handle. In addition, establishing electrical connections between the different elements requires considerable manufacturing steps.

[0044] According to a second aspect of the present invention, the base frame as a support structure allows the number of individual components to be significantly reduced, and also allows several functions to be combined in one assembly. The electrical connector structure includes an electrical conductor, contact, track or strip line suitable for establishing an electrical connection between electrical components supported or held by a non-conductor. The connector structure can be formed by only one component or a small number of components. The non-conductor of the drug delivery device is preferably injection molded around the connector structure. This concept allows various other supporting elements to be integrated into the non-conductor, thereby forming an integral component with extended functions. Other supporting elements can be, for example, support pins for printed circuit boards, retaining elements for holding batteries on non-conductors, guide elements for guiding a movable needle assembly or other movable elements of an inserter mechanism, or stop elements for stopping such movement. By reducing the number of components, the base frame according to the present invention allows the design of the drug delivery device to be compact.

[0045] The conductive parts or connector members of the connector structure can be made of any conductive material, such as metal, metal alloy, conductive plastic or conductive composite material. The connector structure provides an electrical connection between the components supported by the base frame and an external device, which is connected to the electrical contact area of ​​the base frame inseparably or releasably. In addition, the connector structure can provide an electrical connection between various electrical and / or electronic components supported or guided by the base frame.

[0046] The connector structure may include only a single conductive part or connector member, or it may include multiple conductive parts or connector members. Preferably, the connector structure includes at least two separate connector members that are electrically insulated from each other. In this case, all connector members of at least one connector structure are preferably manufactured as a single component, such as a single metal sheet, in a first production step. The shape of the sheet will include all connector members plus some connecting bridges therebetween to form a single conductive component. In a second production step, the conductive sheet or component is overmolded to form an integral component with a non-conductive frame that holds all connector members and connecting bridges. In a third production step, the connecting bridges are removed (e.g., by punching), resulting in an integral component containing a connector structure with one or more separate electrical paths. Compared with using overmolding technology, the manufacturing process is significantly easier and more time-efficient, in which two or more conductive connector members are all inlaid as separate components.

[0047] The electrical contact regions are integrated into the connector structure to form one integral part. However, as mentioned above, the connector structure itself may include more than one conductive part or connector member. Preferably, the first electrical contact region is formed in the first connector member and the second electrical contact region is formed in the second connector member, wherein the first electrical contact region and the second electrical contact region are galvanically different and separated from each other. In this case, the first electrical contact region is preferably adapted to be connected to the positive pole and the second electrical contact region is adapted to be connected to the negative pole.

[0048] The non-conductive body of the drug delivery device is injection molded around the connector structure and thus at least partially encapsulates the connector structure. Thus, the connector structure is supported or held by the non-conductive body. This allows the connector structure to be securely placed, for example, inside 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.

[0049] The non-conductive body is preferably an integral part. Several elements, such as, for example, retaining elements, guide rails, mechanical stop elements, support elements or bearing pins, are integrally formed in the non-conductive body. This means that these elements are preferably made of the same material as the non-conductive body.

[0050] The non-conductive body is injection molded around the connector structure so that the electrical contact area of ​​the connector structure is accessible from outside the non-conductive body. This means that the non-conductive body is not designed to prevent the electrical contact area of ​​the connector structure from establishing contact with the intended connection contact. The electrical contact area of ​​the connector structure may be designed, for example, in the form of an arm or a rod protruding from the non-conductive body, or the non-conductive body may have an opening or a recess, thereby allowing an external device to contact the electrical contact area through the opening or recess.

[0051] The connector structure and the non-conductive body injection molded around the connector structure may form a hybrid component or an integral component manufactured using a two-component (2C) molding technique, also known as insert molding or overmolding.

[0052] The drug delivery device may be an infusion system or an injection system. The drug delivery device may be, for example, an injection pen, or it may be a patch injector that may be applied to the user's skin for the duration of the injection. The infusion system may be, for example, a conventional medical drug pump (such as an insulin pump with an infusion device), or it may be a drug patch pump without an infusion device and that may be attached directly to the user's skin.

[0053] In a preferred embodiment, the drug delivery device is a patch pump comprising reusable parts and disposable parts. The reusable parts may include a drive mechanism and a control unit. The disposable parts are suitable for being replaced after each infusion, and it may include a reservoir with a drug, a mixing assembly with a needle assembly, a sleeve moving assembly for moving at least a portion of the needle assembly, and a base frame according to the present invention. In this cluster, the sleeve moving assembly will include the relevant parts of the inserter assembly that handle the movement of the needle assembly, particularly a retainer for a rigid sleeve and for a soft sleeve.

[0054] In a preferred embodiment, the non-conductive body forms a guide member for guiding the movement of the needle assembly itself or the cannula moving assembly. The term "formed" means that the guide member is integrally formed in the non-conductive body as one integral part. Therefore, the guide member is made of the same material as the rest of the non-conductive body.

[0055] The guide member may guide the movable part of the needle assembly or cannula moving assembly along a linear or straight motion path, along a curved path, along a rotational path, or along a combination of linear, curved and rotational motion paths. The guide member may be implemented, for example, in the form of a rail, a nut, a protrusion or a profile.

[0056] Because the guide member is formed as an integral component in the non-conductive body, no means for connecting the guide member to the non-conductive body are required, e.g., no snap or screw connections are required. The guide member allows easy and quick movement of the cannula and / or other parts of the needle assembly, e.g., from a starting or initial position to an extended or inserted position, where the cannula is inserted into the user's skin.

[0057] Preferably, the guide member is a linear guide for guiding the needle assembly itself or a part of the cannula moving assembly along a linear motion path. "Linear" means that the motion path is a straight line, so that the needle assembly is displaced along a straight line. The guide member may include one or more guides. Preferably, the guide element includes at least one guide, which is adapted to engage with a corresponding counterpart (e.g., a groove) of the needle assembly and / or the cannula moving assembly.

[0058] Advantageously, the non-conductive body may comprise an end stop surface integrated as an integral part in the non-conductive body and wherein the end stop surface is adapted to limit the movement of the needle assembly or the cannula moving assembly in a first direction. The end stop surface is integrally formed in the non-conductive body. Preferably, the end stop surface defines an extended position or an initial position of the needle assembly. The needle assembly is movable from an initial or starting position to an extended or inserted position in which the cannula has pierced the user's skin. The end stop surface may be, for example, a buffer stop, a buffer or simply an element protruding in the direction of movement of the needle assembly.

[0059] Preferably, the connector structure is mainly made of metal. This means that the connector structure is completely made of metal or made of metal and other material components, conductive composite materials or made of metal and additional non-metallic materials. Preferably, the connector structure is made of one conductive metal sheet. This allows easy and efficient production of the connector structure.

[0060] In this case, the connector structure is preferably made by punching and bending. This means that in a first step the outline of the connector structure is defined by punching the connector structure 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-conductor 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 comprise several galvanically different and separate connector components or other electrical paths. In this way, the connector structure can be produced efficiently and at a lower cost.

[0061] In a preferred example, the connector structure comprises at least two electrical contact areas. Preferably, each of the at least two electrical contact areas is arranged on a resilient element or a contact arm of a connector component. This means that the connector structure comprises at least two connector components, each of which comprises a resilient element or a contact arm carrying the electrical contact areas. Therefore, when an external element mechanically and electrically contacts the electrical contact areas, these electrical contact areas can bounce or flex. This can help to reliably establish an electrical connection between the external contact element and the electrical contact area of ​​the connector structure. The external contact element may belong to another device (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 add-on for monitoring an injection or infusion process).

[0062] Preferably, the drug delivery device comprises a switch arm which flexibly protrudes outside the base frame and is formed in the first connector component as an integral part. Thus, the switch arm is made of the same material as the connector structure. The switch arm is preferably directly or indirectly electrically contactable with the second connector component. The first connector component and the second connector component are galvanically separated from each other. If the switch arm electrically contacts the second connector component, an electrical connection is established between the first connector component and the second connector component and thus an electrical signal can be transmitted. Thus, the switch arm can be switched between a conductive state and a non-conductive state by a movable sleeve moving assembly.

[0063] The signal generated can indicate, for example, whether a release button is pressed, whether an external device is connected, or whether a needle assembly is moved into 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 the conductive state and the non-conductive state.

[0064] Advantageously, the switch arm is switchable by the needle assembly or by the inserter assembly such that the switch arm establishes an electrical connection between the first connector component and the second connector component or interrupts an existing electrical connection between the first connector component and the second connector component.

[0065] The switch arm is advantageously positioned beside or near the path of motion of the cannula moving assembly or the needle assembly so that an element of the cannula moving assembly or the needle assembly (e.g., an edge, a protrusion, an actuating lever) can mechanically contact and thus switch the switch arm. The conductive state (electrical connection) or non-conductive state (connection is electrically interrupted) of the switch arm can indicate that the needle assembly is in the initial position or in the extended position or that it is just no longer in the initial or extended position.

[0066] In a preferred embodiment, the non-conductive body may be made mainly of plastic. The non-conductive body may include only plastic or mainly include plastic and other non-conductive materials or composite materials. In either case, the material of the non-conductive body is injection moldable and can therefore be used to overmold the connector structure.

[0067] Further, the non-conductive body may include a retaining element integrated into the non-conductive body as an integral part, the retaining element being used to retain the battery. In addition, the connector structure may include a battery contact element integrated into the connector structure as an integral part, the battery contact element being used to electrically contact the retained battery. The retaining element may be, for example, an arm, a clamp, a retaining tab or a tongue. Thus, the battery can be reliably held relative to the non-conductive body. The battery may be a button cell, a conventional cylindrical cell or a storage battery. If the battery is held and held 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 realized, for example, in the form of a pin, a tab, a tongue or an arm, and may be integrated into the connector structure as an integral part.

[0068] Preferably, the connector structure forms at least two battery contact elements.For electrically contacting the battery, a first battery contact element is adapted to be connected to the positive pole and a second battery contact element is adapted to be connected to the negative pole of the battery.

[0069] 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 sleeve moving assembly. The base frame comprises: a conductive connector structure, which comprises an electrical contact area for establishing an electrical connection; and a non-conductive body, which is injection molded around the connector structure so that the electrical contact area can be contacted from the outside of the non-conductive body. The non-conductive body comprises a guide member for guiding the movement of the needle assembly or the sleeve moving assembly, and the guide member is integrated into the non-conductive body as an integral part. In addition, the present invention relates to a hybrid assembly, which comprises the base frame, the sleeve moving assembly and the needle assembly described above.

[0070] In a preferred example, the mixing assembly further comprises a heater assembly or a melt release module having a heating element, the heater assembly or the melt release module being used to release the piercing process with the needle assembly. The heater assembly is supported by a non-conductive body.

[0071] Release of the piercing process may involve linear or rotational movement of the needle assembly from an initial or starting position to an extended position in which the cannula has pierced the user's skin. The heating element of the heater assembly preferably melts or breaks a fuse that holds the biased needle assembly or cannula moving assembly in its initial position. If the fuse melts or breaks, the insertion trigger or retaining 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.

[0072] The heater assembly with the heating element is preferably supported by and arranged on the non-conductive body, directly or indirectly via further elements.

[0073] In order to control the insertion process, the mixing assembly preferably comprises a printed circuit board (reservoir unit printed circuit board, PCB-RU) supported and held by a non-conductor. The heating element of the heater assembly and other control elements may be arranged on the PCB-RU.

[0074] Preferably, a holding structure for rigidly holding the PCB-RU on the non-conductive body is integrated into the non-conductive body as an integral part. The structure may comprise a pin, a tab or an arm formed as an integral part. The PCB-RU may be fixed to the holding structure, for example by an adhesive, by heat riveting or by a snap lock.

[0075] The design of seals for drug delivery devices is not an isolated task. Fluid impermeability is always defined for a specific area or volume according to the pressure requirements derived from the intended function. To arrive at the design of the present invention, the following pressure requirements have been specified:

[0076] - to allow successful filling of the reservoir through the filling port in the housing, at least the reservoir seal and the filling port seal are fluid tight for a filling pressure of at least 6 bar,

[0077] - in order to allow a successful occlusion detection, at least the seal of the fluid path of the medicament is fluid-tight to an occlusion pressure of at least 2 bar,

[0078] - In order to allow successful protection against intrusion from the environment, at least the seal of the housing is fluid-tight for an ambient overpressure of at least 0.24 bar.

[0079] It is particularly important to meet these requirements and find an overall optimum for sealing at all interfaces relevant to the functioning of the drug delivery device. It is further evident that the values ​​of pressure requirements given above are only examples to explain the advantages of the invention and should by no means limit the application of the concepts described in the present invention to a specific pressure range.

[0080] In a third aspect of the invention, a concept for an improved fill port assembly is described that overcomes the disadvantages of the prior art. The improved fill port assembly ensures fluid tightness at fill pressure, facilitates easy assembly, improves the life and robustness of the device, and can additionally secure the reservoir relative to the housing.

[0081] The object is solved by a drug delivery device for delivering a medicament from a reservoir to a patient, the drug delivery device comprising: a housing comprising a wall separating an inner volume from an exterior; a reservoir located in the inner volume; a filling port assembly located in the wall of the housing and accessible from the exterior for filling the reservoir, the filling port assembly comprising a conical opening for receiving a needle and a pierceable filling port seal separating the reservoir from the exterior, characterized in that the filling port assembly comprises an insert adapted to be received by a channel in the wall of the housing, and wherein the filling port seal performs a sealing function between the housing and the reservoir. Providing a seal between the housing and the reservoir ensures that no fluid can pass between the reservoir and the wall of the housing.

[0082] The current aspect of the present invention is preferably applied to a drug delivery device for delivering a medicament from a reservoir, which is preferably a liquid or solid reconstituted before injection. The reservoir can be a cartridge made of a flexible material or a non-collapsible reservoir or a collapsible reservoir. The drug delivery device includes a housing including a wall separating an internal volume from an external part. The housing can be constructed with any number of components that are connected together to form a substantially closed shell around the internal volume. The reservoir is located in the internal volume. The filling port assembly is located in the wall forming the housing or is a part of the wall forming the housing and is accessible from the outside for filling the reservoir. The reservoir can be filled at the factory, or the user fills the reservoir before use. Preferably, the reservoir is a multi-use reservoir. Optionally, the reservoir is only filled once, and the unit including the reservoir is discarded after use. The filling port assembly includes a cone or conical opening suitable for receiving a needle. The conical opening facilitates the entry of a needle of a filling or transfer device (e.g., a syringe) that contains a medicament for filling an empty reservoir with the medicament. The filling port assembly includes a pierceable filling port seal that separates the reservoir from the outside. The pierceable filling port seal may include a pierceable septum. The filling port seal or the septum of the seal may be pierced by a needle for filling the reservoir. In addition, the filling port assembly includes an insert that is adapted to be received by a passage in the wall of the housing or to be received in the filling port seal, whereby the filling port seal is received in the passage 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 may provide multiple seals to different sections or components in the drug delivery device, and the seal may be a direct seal between the housing and the reservoir or an indirect seal via other housing parts. Multiple seals in the combined filling port assembly may reduce the number of required parts. Using an insert as part of a filling port assembly has the advantage that during assembly, the insert is inserted from the outside into the passage in the wall, thereby also making it possible to fix other parts (e.g., housing parts) or components (such as a reservoir) relative to at least a portion of the housing of the drug delivery device or a reservoir unit of the drug delivery device and simultaneously establish a seal or multiple seals. Thus, the filling port assembly combines the features of enabling the filling of an empty reservoir, sealing the reservoir relative to the housing, and fixing the cartridge or reservoir. Using an insert separate from the housing has the advantage that the two parts can be adapted to their specific needs. The insert can be made of a different material from the housing and thus reduce manufacturing costs, or made of a material with different stiffness or wear resistance, which has the effect of reducing the risk of particle wear, needle blockage or needle damage. The conical opening further facilitates the insertion of the needle through the filling port, especially for visually impaired users.

[0083] The insert of the drug delivery device preferably includes a conical opening and the conical opening extends from the base. The conical opening defines a longitudinal axis and the base is preferably connected to the larger diameter access 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 a wall of the housing. Thus, the conical opening of the insert is adapted to receive and guide a needle tip, such as toward a septum of a filling port seal. The conical opening has a certain angle relative to the longitudinal axis. The opening of the cone is wide to facilitate entry of the needle tip. The cone angle between the longitudinal axis and the conical surface ranges between 20 and 40 degrees, more preferably between 25 and 35 degrees, and most preferably the cone angle is about 30 degrees.

[0084] The fill port seal is preferably sandwiched between the base of the insert and the wall of the housing to provide a first seal between the insert and the housing. The first seal prevents fluid and / or gas from leaking from the interior of the housing to the exterior, or prevents reverse contamination from the exterior from entering the housing. The first seal can be part of the sterility concept to protect the parts inside the housing from environmental influences. The first seal can increase the shelf life or life of the device.

[0085] The filling port seal comprises a flange or rim, which is 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 in the wall surrounding the housing. The first recessed section for the insert may be different 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 rim and preferably has a lateral dimension that is smaller than the lateral dimension of the first recessed section of the base adapted to receive 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, which is oriented along the longitudinal axis of the conical opening and is located between the base of the insert and the housing or the recessed section of the channel surrounding the housing. Receiving the flange of the filling port seal in the second recessed section in the wall protects the filling port seal from lateral movement and aligns the parts (e.g., the channel in the housing, the filling port seal, and the insert) prior to final assembly and / or securing the cartridge. The wall of the housing configured to receive the second recessed section of the filling port seal and / or the base of the insert facing the filling port seal may have a protrusion or convex structure to locally compress the resilient sealing material of the flange.

[0086] The drug delivery device can be further improved by additionally sealing the filling port of the inlet of the reservoir. The inlet of the reservoir 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 inlet of the reservoir is aligned relative to the passage in the housing. The inlet of the reservoir is preferably oriented perpendicular to the longitudinal axis of the reservoir. The inlet of the reservoir is also aligned relative to the conical opening and the diaphragm as a part of the filling port seal so that the needle penetrates the diaphragm to ensure that the medicament can be filled into the reservoir. Therefore, the fluid port assembly provides a fluid-tight closure to the reservoir (preferably, the inlet of the reservoir), and therefore prevents the medicament from leaking into the housing or leaking to the outside from the reservoir. The fluid port assembly also prevents contaminants from the outside from entering the reservoir, and can be a part of a sterile barrier.

[0087] The filling port seal of the drug delivery device can provide a second seal between the filling port seal and the inlet of the reservoir, and the seal is preferably oriented in a radial direction perpendicular to the longitudinal axis of the conical opening. The second seal is preferably axially displaced from the first seal. By positioning the two seals at different positions, two sealing functions in one part are achieved, both of which have (independent) sealing properties, and the material or size can be adapted to specific needs.

[0088] Preferably, the insert and the filling port seal fix the reservoir relative to the housing. Thus, by inserting the filling port seal and the insert into the housing from the outside, the reservoir, which is preferably already present inside the housing, is fixed. The fixation may be based on a form-fit fixation, which alternatively uses a friction fit or a force fit. The fixation may additionally benefit from a snap-fit ​​connection between the reservoir or the inlet of the reservoir and at least one of the parts forming the filling port assembly. The fixation preferably uses the filling port assembly or a part of the filling port assembly that is at least partially located inside the inlet of the reservoir. Alternatively, the neck section or the body of the reservoir is used for fixation. Using the filling port assembly additionally for reservoir fixation means that sealing and fixation are combined, which improves the assembly of the device and reduces parts.

[0089] Preferably, the filling port seal comprises a hole extending from the flange and terminating in the pierceable septum. The hole may be formed by a cylindrical section connecting the pierceable septum to the flange of the filling port seal. Preferably, the pierceable septum forms the end of the hole. The cylindrical section preferably connects the first seal and the second seal.

[0090] Preferably, the insert of the drug delivery device includes a sleeve extending from a conical opening, which starts from the narrow section of the conical opening and is suitable for being received in the hole of the filling port seal. Therefore, the cone can connect the base 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 the pierceable septum of the filling port seal. The guide ensures that the septum is pierced perpendicular to the film forming the septum to prevent the septum from tearing and leaking along the needle during the filling reservoir. The guide also prevents the needle from contacting the inner wall of the entrance, which will bear the risk of wearing particles from the entrance wall and reducing the piercing depth. In addition, the sleeve of the insert is coaxially arranged in the hole formed by the cylindrical section of the filling port seal. The sleeve of the insert, the cylindrical section of the seal and the entrance of the reservoir can be coaxially arranged for inserting the insert and the seal during assembly and for fixing the reservoir of the assembled device. The reservoir may be secured by installing the fill port assembly because the base of the insert is secured in at least one of the recessed sections of the housing and prevents lateral movement of both the fill port seal and the reservoir.

[0091] Preferably, an exterior surface of the fill port seal or an exterior surface of the cylindrical section is at least partially received in the inlet of the reservoir.

[0092] The outer surface of the cylindrical section is preferably press fit 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 against lateral movement. The fill port assembly can secure the reservoir so that there is a shock absorber between the reservoir and the housing, preferably due to the elastic properties of the outer surface of the cylindrical section engaging the inlet of the reservoir. This is advantageous for the device because it improves impact resistance, such as during a drop test.

[0093] The insert for the drug delivery device is made of metal, such as steel, preferably stainless steel or aluminum. Alternatively, the insert is made of a plastic material coated with a metal layer, or made of a plastic material reinforced with a mineral filler (such as glass, zirconium oxide or aluminum oxide particles). An advantage of using metal or toughened plastic is to prevent the needle tip from wearing particles from the insert or even being trapped in the insert. Another advantage of using metal or toughened plastic is to improve the wear resistance of the insert to the extent that the reservoir can be used multiple times, such as the needle is guided and inserted through the filling port assembly multiple times without damaging the insert. Therefore, the life of the insert and the device therewith (particularly for reusable devices) can be improved.

[0094] The filling port seal preferably comprises a thermoplastic polymer and an elastomer. Preferably, the elastomer surrounds the thermoplastic polymer. The advantage is that the thermoplastic polymer has a higher modulus to provide mechanical strength for fixing the reservoir, while improving the suitability of the assembly during the manufacture of the pump. The advantage of using an elastomer is that the elasticity is beneficial to the formation of the seal, and optionally beneficial to the shock absorber. 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 the form of LSR) or elastomeric polyurethane (PUR) or thermoplastic elastomer (TPE). Thermoplastic polymers and elastomers are preferably selected to meet the biocompatibility requirements according to ISO10993, because the parts of the filling port seal can be in contact with the medicament. Thermoplastic polymers and elastomers are preferably injection molded using 2-component injection molding, thereby reducing the number of parts since multiple functions are combined in a single part.

[0095] The insert of the filling port assembly (more preferably, the base of the insert) includes a recess or opening or cutout configured to receive a fixing pin extending from the wall of the housing. The insert may include a plurality of recesses, openings or cutouts suitable for engaging a plurality of fixing pins. The fixing pin is preferably integrally formed on the housing and made of a thermoplastic polymer. The fixing pin is oriented substantially parallel to the cone axis, and the engagement between the cutout and the fixing pin ensures that the insert is properly aligned with the other parts of the filling port assembly and the housing after installation. The engagement between the fixing pin and the opening facilitates assembly and ensures that the insert is rotationally fixed relative to the housing. The insert can be fixed to the housing by heat riveting at least one of the fixing pins (e.g., by heating and deforming the fixing pin). This axial and rotational fixation is fundamental to the reliable and sufficient contact pressure of the filling port seal and therefore to the expected sealing function of the filling port in the case of up to a specified filling pressure.

[0096] Drug delivery according to this aspect of the invention allows assembly of the filling port from the outside of the housing and the use of a separate insert to secure the septum and reservoir.The insert may be made of a different material than the housing material.

[0097] The present aspect of the invention also comprises providing an improved method for assembling a drug delivery device having a filling port according to the above description, the method comprising the steps of:

[0098] - Provide housing, reservoir, fill port seal and insert,

[0099] - Insertion of the reservoir into the housing from the outside along an axis perpendicular to the cone axis, followed by

[0100] - Insert the fill port seal from the outside into the channel 211c in the wall of the housing along the cone axis, followed by

[0101] - Inserting 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.

[0102] The method may additionally comprise the following steps:

[0103] The opening or cutout of the insert is positioned over a securing pin extending from a wall of the housing of the drug delivery device or disposable unit, followed by heat staking the securing pin to secure the insert to the housing. Alternatively, ultrasonic welding, laser welding, use of an adhesive or heat welding may be used to secure the insert to the housing.

[0104] In a fourth aspect of the invention, the concept of an improved seal for a drug delivery device at the interface of a reservoir and a needle assembly that directs the drug from the reservoir and toward the cannula is described. The reservoir outlet seal design ensures fluid tightness at occlusion pressures, facilitates easy assembly, and improves the life and robustness of the device.

[0105] The object is solved by a drug delivery device, the drug delivery device comprising: a housing having a reservoir located inside the housing to accommodate a drug; a needle assembly having an input portion and an output portion; and a pierceable reservoir outlet seal; whereby the reservoir comprises 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 into the reservoir housing as an integral component; the reservoir outlet seal is at least partially cylindrical and is configured to be inserted into the reservoir outlet seal cavity during the manufacture of the patch pump, pierced by the input portion of the needle assembly during manufacture, and to form a fluid-tight connection between the reservoir and the input portion of the needle assembly. The at least partially cylindrical design of the reservoir outlet seal facilitates the assembly process that ensures fluid impermeability under filling and / or blocking pressures and an easier assembly process than other geometries. In a variation of this design, the soft reservoir outlet seal can be manufactured as an integral component using double shot injection molding together with the rigid reservoir housing.

[0106] In the fifth aspect of the present invention, the concept of an improved seal for a drug delivery device at the interface of a rigid cannula (as part of the input portion of the needle assembly) and a soft cannula (as part of the output portion of the needle assembly) is described. The soft cannula input seal design ensures fluid tightness at occlusion pressure, facilitates easy assembly and improves the life and robustness of the device.

[0107] This object is solved by a drug delivery device, which includes: a housing having a reservoir located inside the housing to contain a drug; a needle assembly having an input part and an output part; whereby the needle assembly includes a soft sleeve having an open distal end and a rigid sleeve at least partially and slidably arranged in a soft sleeve inner lumen of the soft sleeve; the proximal input end of the rigid sleeve is part of the input part of the needle assembly, and the distal output end of the soft sleeve is part of the output part of the needle assembly; whereby the proximal input end of the soft sleeve forms a sliding soft sleeve input seal, which is configured to slide on the rigid sleeve while applying a tightening pressure to ensure a fluid-tight seal under occlusion pressure.

[0108] In a sixth aspect of the invention, the concept of an improved seal for a drug delivery device at the interface of the housing and the output portion of the needle assembly is described. The improved outlet port seal ensures fluid tightness of the housing at ambient pressure, reduces the number of components of the drug delivery device, promotes easy assembly, saves costs and improves the life and robustness of the device.

[0109] The object is solved by a drug delivery device, which includes: a housing having an encapsulating surface that separates an internal volume from an exterior; a reservoir located inside the housing to contain a drug; a needle assembly having an input portion and an output portion; and an outlet port assembly, whereby the housing includes at least two components configured to be attached to each other to form a protective shell of the drug delivery device; the reservoir includes a reservoir outlet coupled to the input portion of the needle assembly; the housing includes an outlet port opening for providing a passage from the interior of the housing to the exterior of the output portion of the needle assembly; the outlet port assembly is configured to be connected between the housing and the output portion of the needle assembly The outlet port assembly comprises: 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 an output portion of a needle assembly; and a soft outlet port seal that is attached to the rigid outlet port seal holder during manufacture of the drug delivery device; the soft outlet port seal being configured to be pierced by the output portion of the needle assembly during manufacture of the drug delivery device; and whereby the soft outlet port seal is further configured to provide a fluid-tight closure to the outlet port opening of the housing when the outlet port assembly is mounted on the housing.

[0110] Three exemplary methods of implementing this concept are explicitly described in the following paragraphs.

[0111] One outlet port seal design according to the concept as described is achieved by manufacturing the outlet port assembly as an integral component including a rigid outlet port seal retainer and a soft outlet port seal using a two-shot injection molding process.

[0112] Another outlet port seal design according to the concept as described is achieved by coupling the outlet port assembly with one of the at least two housing parts and manufacturing the outlet port assembly as an integral part using a two-shot injection molding process, the integral part comprising at least one of the at least two housing parts, a rigid outlet port seal holder and a soft outlet port seal. Insofar as it comprises a portion of the housing, the multifunctional part may particularly comprise other seals of the housing, such as a seal at the mechanical interface between the reservoir unit and the pump unit of a semi-disposable patch pump.

[0113] Another outlet port seal design according to the concept as described is achieved by adapting the rigid outlet port seal holder to further include the following: an outlet port seal plug cavity, which defines an outlet port seal plug cavity axis and is open on at least one end to receive a soft outlet port seal; the outlet port seal 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 seal plug cavity axis; the outlet port seal plug cavity axis and the outlet port channel axis intersect at an angle of at least 10 degrees, preferably at least 45 degrees; the soft outlet port seal is inserted into the outlet port seal plug cavity during manufacture of the drug delivery device; and the soft outlet port seal is configured to tightly close the outlet port seal plug cavity and the outlet port opening when installed in the rigid outlet port seal holder.

[0114] Another advantageous feature of the outlet port seal design according to the concept as described is achieved by modifying the outlet port seal plug cavity to include a narrowing and / or flattening portion at the outlet port opening to improve the compression and / or shaping of the soft outlet port seal at the intersection with the outlet port channel. The increased compression brings fluid impermeability at higher pressures, and the flat shape of the outlet port seal is easier to pierce during manufacturing.

[0115] According to the outlet port seal design of the concept as described, the other advantageous features are achieved by the following steps: modifying the shape of the housing in one of the devices described above; and introducing a recess from the encapsulation surface of the housing at the outlet port opening. In the case where the outlet port is located in the recess, the patch pump can be manufactured to be ready to use when the output portion of the needle assembly has passed through the outlet port, thereby providing sufficient sealing and ease of use without any parts protruding from the encapsulation surface of the housing. Further, the recess in the housing forms an external outlet port chamber between the recessed outlet port opening and the encapsulation surface of the housing, which allows the reservoir to be filled and the fluid path to be filled before use without the risk of any medicament being injected into the patient's body. By filling the fluid path with medicament before inserting the cannula into the patient's body and before starting drug delivery, the pump avoids infusing air instead of medicament at the beginning of the infusion process and improves the accuracy of drug delivery.

[0116] Regardless of the method of implementation, the features of the outlet port seal design according to the concept as described are particularly advantageous for a semi-disposable patch pump having a needle assembly, whereby the needle assembly comprises: a flexible cannula having an open distal end; a rigid cannula at least partially and slidably disposed in an inner flexible cannula lumen of the flexible cannula; and a needle insertion mechanism configured to bring an output portion of the needle assembly having at least the open distal end of the flexible cannula from a first position inside the outlet port chamber to a second position outside the outlet port chamber in the exterior of the housing. Such an insertion mechanism greatly improves ease of use.

[0117] In a seventh aspect of the invention, the concept of an improved seal for a patch pump at the interface with the environment in the area of ​​the housing and the outlet port before the pump is applied to the patient's body is described. The outlet port cover design ensures fluid impermeability at the minimum filling pressure as specified for use of the patch pump, supports the process of filling and priming, and promotes easy assembly and use of the device.

[0118] This object is solved by a drug delivery device having an outlet port located in a recess of a housing (such as, for example, the device described in the previous aspect of the invention) and an outlet port cover, whereby the outlet port cover is removably attached to the housing at a portion of the housing 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 includes a membrane made of any semi-permeable material, the membrane being suitable for allowing air to pass through while preventing liquid from passing through; the outlet port cover includes a membrane reinforcement structure that is 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 can be a plastic sheet with a cutout for the outlet port opening.

[0119] In an eighth aspect of the invention, the concept of an improved seal for a patch pump at the interface with the environment in the area of ​​the housing and the outlet port after the pump is attached to the patient's body is described. The design of the housing and the design of the adhesive patch assembly improves the reliability and robustness of the drug delivery while also providing an easier and more comfortable use of the patch pump.

[0120] This object is solved by a drug delivery device as described above and used as a patch pump, the patch pump having an adhesive patch assembly for attaching the pump to a patient, whereby the adhesive patch assembly includes an adhesive layer configured to attach the adhesive patch assembly to the patient after preparing the patch pump for drug delivery; the adhesive patch assembly includes a removable adhesive release liner for protecting the adhesive layer from accidental adhesion prior to use, in particular during preparing the patch pump for drug delivery; the outlet port cover is permanently fixed to the adhesive release liner and removably connected to the housing; and the outlet port cover is configured to be removed from the housing together with the adhesive release liner during preparing the patch pump for drug delivery.

[0121] The design of the housing and adhesive patch assembly in the area of ​​the outlet port is particularly advantageous for a patch pump as described above, whereby the housing further includes a membrane-supporting structure arranged around the outlet port chamber; the membrane-supporting structure is suitable for protruding outwardly from the housing to a height substantially the same as the thickness of the adhesive patch assembly; the membrane-supporting structure is configured to provide contact with the outlet port cover when the outlet port cover is removably attached to the housing; the membrane-supporting structure is configured to provide a fluid-tight connection between the outlet port cover and the housing and thereby tightly seal the outlet port chamber during preparation of the patch pump for drug delivery.

[0122] Although the adhesive patch assembly is reliably attached to the patient's body (particularly in the region of the outlet port) is important for the reliability of drug delivery, the further improvement of the patch pump design at the interface between the environment in the region of the housing and the outlet port is to introduce many ventilation channels (airing channel) at a distance from the outlet port. They allow air and / or moisture to leave the interface and improve the adhesion of the patch pump to the patient's body during drug delivery. This is achieved with the patch pump as described above, whereby the housing and / or the adhesive patch assembly further include at least one ventilation structure, the 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 the adhesive patch. The horizontal distance of the ventilation channel from the outlet port chamber is important for maintaining tight closure around the outlet port and avoiding the connection of the ventilation structure with the outlet port chamber. The ventilation structure is configured to allow air to pass from the inner end 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 toward the shell - if the ventilation structure is formed by the shell or by other layers of the adhesive patch assembly. BRIEF DESCRIPTION OF THE DRAWINGS

[0123] 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:

[0124] Figure 1 depicts perspective views of a patch pump as seen from above (away from the patient, left) and from below (toward the patient, right);

[0125] Figure 2a , Figure 2b Refers to the mechanical interface between the pump unit and the reservoir unit;

[0126] Figure 2a The drive mechanism of the patch pump spanning these two units is depicted;

[0127] Figure 2b A bayonet connection between a pump unit and a reservoir unit of a patch pump is depicted;

[0128] Figure 3a , Figure 3b refers to the step of attaching the pump unit to the reservoir unit of the patch pump;

[0129] Figure 3a A patch pump is depicted in which the pump module is connected to the bayonet of the reservoir module at a 30° angle;

[0130] Figure 3b Depicted is a cross-section of the patch pump at the locking mechanism, with the locking mechanism enclosed (left: full cut, right: magnified view of the locking mechanism);

[0131] Figure 4 depicts a patch pump attached to a patient's body and ready for drug delivery;

[0132] Figure 5 depicts the reservoir unit of the patch pump without the front side of the housing and the adhesive release liner;

[0133] Figure 6a , Figure 6b refers to a perspective view of a mixing assembly having a sleeve moving assembly;

[0134] Figure 6a depicts a perspective view of the mixing assembly with the sleeve moving assembly in an initial position;

[0135] Figure 6b Depicted Figure 6a A mixing assembly, but wherein the sleeve moving assembly is in an extended position;

[0136] Figure 7 Depicted Figure 6a , Figure 6b A bottom view of a mixing assembly;

[0137] Figure 8a -c refers to the perspective view of the base frame;

[0138] Figure 8a depicts a perspective view of a base frame including a non-conductive body and a connector structure;

[0139] Figure 8b A perspective view of the non-conductive body of the base frame is depicted from the bottom up;

[0140] Figure 8c depicts the connector structure of the base frame;

[0141] Figure 9a , Figure 9b refers to a perspective view of a reservoir unit with a filling port after being secured by hot stemming;

[0142] Figure 9a depicts a perspective view of a reservoir unit partially assembled and turned bottom-up to show a fill port at the bottom of the unit;

[0143] Figure 9b depicts a cross section of a reservoir unit having a fixed fill port assembly and a reservoir inlet;

[0144] Fig.10 Depicts the fill port from the as seen before it is secured by heat staking. Figure 9a , Figure 9b A cross section of a reservoir unit;

[0145] Fig.11 Depicted from Figure 9a , Figure 9b A cross section of a reservoir unit with a fill port seal inserted and without an insert;

[0146] Fig.12 Depicts the fill port assembly from Figure 9a , Figure 9b A cross section of a reservoir unit;

[0147] Fig.13 depicts a perspective view of the insert;

[0148] Fig.14 The fill port seal is depicted in perspective (left) and cross-section (right);

[0149] Fig.15 depicts a perspective view of a reservoir including a plunger;

[0150] Fig.16 depicts an exploded view of a reservoir unit showing the insertion of a cartridge and fill port assembly into a reservoir unit housing to form the reservoir unit;

[0151] Fig.17 depicts a perspective view of a pump unit with the housing removed;

[0152] Fig.18 depicts a perspective view of a reservoir unit with a portion of the housing removed;

[0153] Fig.19 A patch pump with a reservoir outlet seal is depicted in cross-section through the reservoir outlet;

[0154] Fig. 20 depicts a cross-section of a patch pump having a flexible cannula input seal;

[0155] Fig.21a , Figure 21b A schematic diagram referring to a patch pump having an outlet port;

[0156] Fig.21a depicts a patch pump having an outlet port in a flat region of the housing;

[0157] Figure 21b depicts a patch pump having an outlet port in a housing, wherein a recess is at the outlet port;

[0158] Fig.22a , Figure 22b refers to an outlet port assembly of a first preferred embodiment of an outlet port;

[0159] Fig.22a A preferred embodiment of an outlet port assembly is depicted in perspective view (left) and cross-section view (right);

[0160] Figure 22b Depicts a cross-sectional view of an embodiment of a fully assembled patch pump having Fig.22a An outlet port component;

[0161] Fig.23a -c refers to an outlet port assembly of a second preferred embodiment of an outlet port;

[0162] Fig.23a A preferred embodiment of the outlet port assembly is depicted in a perspective view cut through the outlet port passage;

[0163] Figure 23b A preferred embodiment of the outlet port assembly is depicted in cross-section (right);

[0164] Fig.23c Depicts a cross-sectional view of an embodiment of a fully assembled patch pump having Fig.23a An outlet port component;

[0165] Fig.24a -d refers to the outlet port assembly of the third preferred embodiment of the outlet port;

[0166] Fig.24a The housing component with the integrated rigid outlet port seal holder is shown in a perspective view from the outside (left) and in a cross-section of the outlet port (right) before the insertion of the soft outlet port seal;

[0167] Figure 24b depicts a cross-sectional view through the outlet port passage as viewed from within the housing to further illustrate the outlet port sealing plug cavity prior to assembly;

[0168] Fig.24c depicts a cross-sectional view through an outlet port passage as viewed from the interior of a housing with a soft outlet port seal installed into an outlet port sealing plug cavity;

[0169] Fig.24d depicts a cross-sectional view of the outlet port after the seal has been pierced by the needle assembly;

[0170] Fig.25a -e refers to the outlet port assembly of the fourth preferred embodiment of the outlet port;

[0171] Fig.25a The housing component with the integrated rigid outlet port seal holder is shown in a perspective view from the outside (left) and in a cross-section of the outlet port (right) before the insertion of the soft outlet port seal;

[0172] Fig.25b depicts a cross-sectional view through the outlet port passage as viewed from within the housing to further illustrate the outlet port sealing plug cavity prior to assembly;

[0173] Fig.25c depicts a cross-sectional view through an outlet port passage as viewed from the interior of a housing with a soft outlet port seal installed into an outlet port sealing plug cavity;

[0174] Fig.25d Depicts the insertion into Fig.25b The soft outlet port seal before (left) and after (right) in the outlet port seal plug cavity;

[0175] Fig.25e depicts a cross-sectional view of the outlet port after the seal has been pierced by the needle assembly;

[0176] Fig.26a -c refers to an outlet port having an outlet port chamber and an outlet port cover;

[0177] Fig.26a depicting an outlet port cover enclosing an outlet port chamber;

[0178] Figure 26b depicts an outlet port cover in an embodiment having a membrane bearing structure;

[0179] Fig.26c depicts an exploded view of an adhesive assembly in combination with an outlet port cover;

[0180] Fig. 27 depicts the ventilation grooves at the base of the patch pump;

[0181] The reference symbols used in the drawings and their main meanings are listed in summary form in the list of names. In principle, identical parts are provided with the same reference symbols in the drawings. DETAILED DESCRIPTION

[0182] 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 suitable for performing complex treatments at the lowest possible cost. Figure 1 and Figure 2a , Figure 2bThe example of a wearable patch pump shown in explains the most preferred embodiment, but it is obvious that the same aspects of the invention can also be used to improve any other kind of drug delivery device as long as comparable features exist. Cost benefits are particularly achieved by introducing new and improved manufacturing and / or assembly methods for drug delivery devices, as described according to the following aspects.

[0183] Figure 1 A perspective view of a preferred embodiment of a 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 medicament and a needle assembly having a fluid path for bringing the medicament 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 by a bayonet connector. Figure 1 (Left) shows the complete patch pump 1 with both units connected and seen from a position above the pump. In the context of the present invention, "above" or "top" refers to the side of the pump that faces away from the patient's body when the pump is attached to the patient for drug delivery. Thus, "bottom" or "base" refers to the side of the pump that faces the patient's body during drug delivery. Figure 1 (left), arrow 114 indicates the direction towards the open side of the patch pump 1 where the pump unit 100 is lifted off the bottom of the reservoir unit 200 . Figure 1 (Right) The same pump is shown turned around to obtain a bottom view of the patch pump 1 with the adhesive patch assembly 280 .

[0184] like Figure 2a As shown in the figure, the pump unit 100 includes: a drive mechanism for driving a plunger rod 122; an encoder for supervising the movement of the drive mechanism; a rechargeable battery; and a programmable electronic system control circuit, which is configured to control the settings, drug delivery and supervision of the pump. When the drive mechanism is connected to the reservoir unit 200, the battery can be recharged by another battery in the disposable reservoir unit 200.

[0185] The drive mechanism 120 acts mechanically on the plunger 221 in the reservoir 222 via the plunger rod 122 from the threaded rod 125 to dispense the medical substance out of the reservoir 222. The needle assembly 260 inside the reservoir unit provides a fluid connection from the reservoir 222 to the outside of the pump for application to the patient. In order to ensure safe handling, the patch pump is manufactured, transported, stored and prepared for use completely inside the encapsulated shape of the pump 1 with the needle assembly 260. The encapsulated shape is an imaginary surface that encapsulates the housing of the pump 1 while smoothly bridging all gaps and recesses (if any gaps and recesses exist) to the closed shell. It is the shape of the pump 1 as perceived by the user from a distance, and is relevant when it comes to use aspects such as handling or wearability. In this embodiment, preparing the patch pump includes: filling the reservoir in the reservoir unit 200 from the outside using a transfer syringe; and attaching the pump to the patient's body by means of an adhesive patch assembly 280. The inserter assembly is included in the reservoir unit 200 and is configured to bring the output portion of the needle assembly 260 (particularly the open distal end of the needle assembly 260) out of the encapsulated shape of the pump and into the patient's body once the pump is ready to begin drug delivery. In a preferred embodiment of the patch pump, the needle assembly 260 includes a rigid cannula and a soft cannula, and the inserter is configured to insert the distal end of the soft cannula into the patient's body using the rigid cannula, which will then be retracted for drug delivery.

[0186] The rechargeable battery provides power for the drive mechanism and the system control circuit. The system control circuit controls the drive mechanism and can exchange data with an external control device, such as via a wireless data connection. In addition, the rechargeable battery can provide power for the inserter assembly in the reservoir unit 200.

[0187] Figure 2b The view from above shows the Figure 1 A semi-disposable patch pump in which the pump unit 100 and the reservoir unit 200 have been removed and separated, with the adhesive patch assembly 280 at the bottom toward the patient's body and the bayonet connector 212a in a disengaged state.

[0188] The first group of preferred embodiments illustrates the first aspect of the present invention. They are based on the above described Figure 1 and Figure 2a , Figure 2b The wearable semi-disposable patch pumps shown in . They are further described in the following paragraphs.

[0189] The overall objective of the present invention is to provide a semi-disposable patch pump that is optimized for ease of use, cost-effectiveness, and minimal waste. Figure 1 and Figure 2a , Figure 2bGENERAL DESCRIPTION OF EMBODIMENTS It is apparent that the patient has only two components to assemble: a reusable pump unit 100, all components of which are intended for multiple or continuous use; and a disposable reservoir unit 200, all components of which are intended for a single use. Figure 2b A preferred embodiment of a semi-disposable patch pump according to the present invention is shown, wherein the pump unit 100 and the reservoir unit 200 are ready for application. The reservoir unit 200 is shown from the outside with a reservoir unit housing 211 mounted on an adhesive patch assembly 280 and a mechanical interface to the pump unit (in particular, a bayonet connector 212a shown on both units, the axis of rotation 212b of the bayonet connector is shown on both units, and a locking structure 212d is integrated in the reservoir unit housing 211. The locking mechanism for the bayonet connector includes a 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 where the housing is attached to the adhesive patch assembly 280. Depending on the embodiment, the base plate can be one integral component or a combination of components permanently connected together and attached to the adhesive patch assembly 280. The design of the bayonet connector includes the definition of an opening side 114 of the pump, which refers to the general direction or external face of the pump unit that is lifted off the base plate to open the connector and remove the pump unit. Figure 2b , the base plate is shown with a base plate extension 212c on the open side 114. When the pump unit 100 is rotated 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 connection, as it would otherwise inhibit connection of the pump unit to the reservoir unit.

[0190] exist Fig.16 and 18 , with selected parts removed to show the internal components. In particular, the reservoir 222 is shown with 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, a reservoir axis 222e along the axial center of the reservoir 222 and plunger 221 is arranged to be aligned with the rotation axis 212b ( Figure 2b ) coincides with and is substantially orthogonal to the wall of the reservoir unit housing that faces the pump unit.

[0191] exist Figure 2a , Figure 2b and Fig.17, with selected parts removed to show the internal components. In particular, the drive mechanism 120 is shown with: a drive device, which is realized as a threaded rod 125 mounted in and cooperating with a plunger rod 122; a rechargeable battery 150; and a system control circuit 140. The threaded rod 125 and the plunger rod 122 are arranged in a direction that is substantially identical to the rotation axis 212b of the bayonet connection in the fully assembled state and is substantially orthogonal to the wall of the pump unit housing facing the reservoir unit.

[0192] In order to apply the patch pump 1 and start drug delivery, the patient removes the reservoir unit 200 from the package. If the reservoir is not pre-filled with drugs, the patient fills the drug into the reservoir 222. The pump unit 100 will usually have been activated from the 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 can be used, such as remote control units with wireless connections and software for interacting with users and establishing communications with pump units. In order to attach the pump unit 100 to the reservoir unit 200, the user makes the bayonet connector 212a on the pump unit 100 contact the bayonet connector 212a on the reservoir unit 200 along the bayonet rotation axis 212b at an open angle. Depending on the design of the bayonet structure, the open angle is usually in the range of 5 degrees to 180 degrees, preferably 15 degrees to 45 degrees. The user pushes the two components together along the axis of rotation of the bayonet connection 212a and folds the pump unit 100 down 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 the opening behind the plunger 221 in the reservoir unit. With the bayonet components in place, the pump unit 100 is folded down onto the plane of the base plate 211a to close the connection. Figure 3a This step is shown with the pump unit at a connection angle of 30 degrees. The user ensures that the bayonet connection is properly locked by pressing the pump unit 100 down onto the base plate 211a. By doing so, the flexible latch spring 113a of the reusable pump unit engages with the locking structure 212d integrated into the housing of the disposable reservoir unit 200 and locks the bayonet connection in the closed position. Figure 3b This state is illustrated in . Obviously, the bayonet connection of the present invention may also include any other locking mechanism, such as a magnetic lock, velcro, a latch or an adhesive lock, provided that the lock can be released without introducing an additional unlocking step.

[0193] exist Figure 4, the patch pump 1 has been applied to the body of the patient 300 and is ready for drug delivery. The encapsulating surface or outer shape of the patch pump 1 is substantially edgeless and suitable for wearing with minimal risk of wiping the device off when sliding over an edge, such as a door frame.

[0194] After successfully delivering the drug inside the reservoir, the patient removes the pump from his or her body. A single mechanical handling step is required to remove the pump unit from the used reservoir unit and prepare for a new reservoir unit. 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 will unlock the locking mechanism and open the bayonet. To further facilitate this handling step, a cutout 211m can be formed on the base plate 211a or the base plate extension 212c on the open side 114 of the pump 1. The cutout 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 cutout can have any shape along the edge of the base plate 211a, preferably elongated, about as long as the width of a finger and wide enough to produce a tactile effect. Thus, the dimensions of the cutout 211m along the base plate 211a and / or base plate extension 212c will typically be 5 mm to 30 mm in length along the edge and 1 mm to 10 mm in width away from the original edge of the base plate 211a and / or base plate extension 212c. Figure 3a , an example of a cutout is shown at the edge of the base plate extension 211a. When folded to the open angle of the bayonet connection, the pump unit can be detached from the reservoir unit and attached to a new reservoir unit to continue treatment.

[0195] Another group of preferred embodiments illustrates the second aspect of the present invention. They are based on the above described Figure 1 and Figure 2a , Figure 2b The wearable semi-disposable patch pumps shown in . They are further described in the following paragraphs.

[0196] Figure 5 , Figure 6a and Figure 7 The reservoir unit 200 is shown (from bottom to top) with selected parts removed to allow viewing of the interior of the reservoir unit 200. The reservoir unit 200 comprises a reservoir unit housing 211, a reservoir 222 with a medical substance, a mixing assembly 240 according to the present invention, a button cell battery 244, and an adhesive patch (not shown) for connecting the patch pump 1 to the skin of a user.

[0197] Figure 6a , Figure 6b and Figure 7 A mixing assembly 240 is depicted, which is arranged as shown in FIG. Figure 5 The interior of the reservoir unit housing 211 of the reservoir unit 200 is shown in FIG. The mixing assembly 240 includes parts of the inserter assembly 250, specifically the cannula moving assembly 251. Figure 6a The mixing assembly 240 is depicted with the cannula moving assembly 251 in a biased initial position. The inserter assembly 250 moves the cannula moving assembly 251 from the biased initial position to an extended position for drug delivery. This movement can be, for example, caused by an elastic element such as an insertion spring 252 ( Figure 7 )) of the system drive, wherein at least one of the elastic elements is preloaded during manufacture of the patch pump. Figure 6b The mixing assembly is depicted with the cannula movement assembly 251 in an extended position for drug delivery. Figure 7 A bottom view of mixing assembly 240 is shown.

[0198] like Figure 6a As shown in FIG. 2 , 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 .

[0199] Hereinafter, the structural features of the base frame 241 are described in detail. Subsequently, the function of the mixing assembly 240 is described.

[0200] 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 that is injection molded around the connector structure 270.

[0201] In the first manufacturing step, the connector components 271a-271d are stamped from sheet metal. At this stage, the connector components 271a-271d are physically connected to each other by bridges, which are metal elements for temporary connection. In the second step, the connector components 271a-271d stamped from sheet metal are bent to form electrical contact areas and arms. In the third step, the connector components 271a-271d are overmolded by non-conductive plastic to form a non-conductive body 290 around the inlaid metal structure. In the fourth step, the bridges between the connector components 271a-271d are eliminated by stamping to separate the connector components 271a-271d from each other in the current. The connector components 271a-271d are made of conductive metal. The injection molded non-conductive body 290 is made of non-conductive plastic.

[0202] Each of the four connector members 271a-271d includes a contact arm 272 ( Figure 8c). Each contact arm includes a bent portion. Figure 8c As shown in FIG. 2 , the first free end of the contact arm 272 forms a first electrical contact region 272 a .

[0203] The first connector member 271a, the second connector member 271b and the third connector member 271c each include a second end of the contact arm 272, wherein the second electrical contact region 272b is adapted to electrically contact the non-conductive body 290 (see Figure 8a , Figure 6a , Figure 6b ) Supporting PCB-RU 243.

[0204] The first connector member 271a additionally includes Figure 8c 271a and the first battery contact arm 274. The switch arm 273 is integrally formed in the first connector member 271a and is resiliently retained relative to the rest of the connector member. The switch arm 273 includes a contact surface on its free end, which is suitable for establishing contact with the pump unit printed circuit board PCB-PU 141 (see FIG. 141 ) when the pump unit 100 is connected to the reservoir unit 200. Fig.17 ). The first battery contact arm 274 includes a first battery contact area 274a on its free end, which is suitable for connecting to the positive terminal of the button battery 244.

[0205] The fourth connector member 271d comprises only the first electrical contact region 272a and a second battery contact arm 275 comprising at its free end a second battery contact region 275a adapted to be connected to the negative pole of the button cell 244 .

[0206] refer to Figure 8a-8c , the non-conductive body 290 is described in detail. The non-conductive body 290 includes a first opening 291 extending through the non-conductive body, through which the first electrical contact area 272a of the contact arm 272 can be contacted from the outside of the base frame 241. Through a second opening 292 in the middle of the non-conductive body 290, the second electrical contact area 272b can be electrically connected to the reservoir unit printed circuit board (PCB-RU) 243. The switch arm 273 also protrudes through the second opening 292. On the bottom side of the non-conductive body 290, the first battery contact arm 274 and the second battery contact arm 275 extend from the non-conductive body 290, so that the first battery contact arm 274 and the second battery contact arm 275 can contact the positive and negative poles of the battery 244, respectively.

[0207] like Figure 8a As depicted in FIG. 1 , the non-conductive body 290 integrally forms a linear guide for the sleeve moving assembly 251, which includes a soft sleeve retainer 253 and a rigid sleeve retainer 254 (see FIG. 1 ). Figure 6a , Figure 6b , Figure 7 ).like Figure 8a -c, the linear guide comprises an upper guide rail 295 and a lower guide rail 296. The upper guide rail 295 is adapted to guide the flexible sleeve holder 253 and the rigid sleeve holder 254 so that these holders can be displaced between a retracted position and an extended position, the extended position being at the second end of the guide rails 295, 296. The lower guide rail 296 is adapted to guide a retraction control part for retracting the rigid sleeve holder 254 so that the control part can be linearly displaced along the lower guide rail 296. An end stop surface 297 is arranged at the first end of the guide rails 295, 296, which limits the linear movement of the flexible sleeve holder 253 and the rigid sleeve holder 254 and defines the initial or retracted position of the holders 253, 254.

[0208] On the upper side, four fixing pins 293 are integrated into the non-conductive body 290. During assembly, a reservoir unit printed circuit board (RU-PCB) 243 is mounted on the four fixing pins 293 and fixed by heat riveting.

[0209] On the bottom side of the base frame 241, the non-conductive body 290 forms a battery opening 245 ( Figure 7 ). A holding element 246 for holding the battery 244 is arranged next to the battery opening 245. Figure 7 The holding element 246 depicted in FIG. 2 is integrally formed in the non-conductive body 290. When the battery is inserted into the battery opening 245, the holding element 246 is elastically deflected to facilitate the insertion of the battery. If the insertion is completed and the battery is placed in the battery opening 245, the holding element 246 elastically moves backward and thus holds the battery 244 in the battery opening 245.

[0210] FIG. 8 is a view of a non-conductive body 290 without an embedded conductive structure ( Figure 8b ) and in a view of the conductive structure as it exists after completed manufacturing ( Figure 8c ) shows the base frame 241 as a complete integral component ( Figure 8a ).like Figure 8b As best seen in FIG. 2 , the non-conductive body 290 further integrally forms a conical support pin 294 on an upper side of the non-conductive body 290. The support pin 294 is adapted to pivotally support the insertion trigger 256.

[0211] In the final assembled state, the complete mixing assembly 240 is placed inside the reservoir unit housing 211 of the reservoir unit 200, as shown in FIG. Figure 5If the pump unit 100 of the patch pump 1 is connected to the reservoir unit 200 via the bayonet connector 212a, the connecting pin 142 (see Fig.17 ) is pressed onto the first electrical contact area 272a of each of the contact arms 272. Thereby, electrical connections are established between the battery 244 of the reservoir unit 200 and the system control circuit 140 in the pump unit 100, and between the reservoir unit printed circuit board PCB-RU 243 and the system control circuit 140 in the pump unit 100.

[0212] Through the electrical connection between the pump unit 100 and the reservoir unit 200, the rechargeable battery 150 in the pump unit 100 can be charged by the button battery 244 in the reservoir unit 200. With the help of the electrical connection between the PCB-RU 243 and the PCB-PU 141 in the pump unit 100, the system control circuit 140 can control the heating element of the heater assembly on the PCB-RU 243. In the same way, the system control circuit can control other elements on the PCB-RU 243 and / or obtain and process information about the status of the reservoir unit (such as the position of the needle assembly).

[0213] If the control circuit 140 of the pump unit 100 sends a release command to the PCB-RU 243 in the reservoir unit, the heating element of the heater assembly is activated. The heating element may then heat the fuse to cause it to melt, extend, or break. This may trigger the release of the biased insertion trigger 256, which is supported by the support pin 294 (see Figure 6a and Figure 6b ) 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, 254 are released, they are driven by the spring 252 guided by the guide rails 295, 296 to move to the extended position and thereby insert the soft cannula and the rigid cannula into the user's skin. The insertion mechanism is described in detail in European patent application EP 18199475.7, which is incorporated by reference in its entirety.

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

[0215] Figure 9aA 3-dimensional overview of a reservoir unit 200 comprising a reservoir or cartridge 222 and a filling port assembly 230 is shown, the reservoir unit being turned upside down from the bottom up, where the filling port is located in this example. The reservoir unit 200 comprises a housing 211 formed by a bottom wall 211g, side walls 211h and a top wall 211i. These walls of the housing define an interior space having an opening for receiving the reservoir 222 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 an empty reservoir 222 closed by a plunger 221, see Figure 9b Details of the fill port assembly 230, housing, and reservoir 222 are presented in cross-sectional views for each of the following:

[0216] - Figure 9b The assembled and fixed fill port assembly 230,

[0217] - Fig.10 The assembled but not yet secured fill port assembly 230,

[0218] - Fig.11 a partially assembled fill port assembly without insert 235, and

[0219] - Fig.12 The housing and reservoir components.

[0220] As in Fig.16 Exploded diagram and Fig.12 As best seen in the cross-section of FIG. 2 , the housing 211 (preferably, the bottom wall 211g) includes a channel 211c adapted to receive the 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 a recess or recessed section (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 of the housing) includes at least one fixing pin 211e, which is preferably made of the same thermoplastic polymer as the housing.

[0221] In order to properly position and fix the reservoir inside 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, which is located at the bottom of the reservoir. Fig.12211k. With the stabilizing protrusion positioned in the stabilizing recess 211k, the reservoir is properly positioned and laterally secured to allow lateral pressure to be used to install the fill port assembly. Further, the interaction between the stabilizing protrusion and the stabilizing recess can be designed as a snap-fit ​​connector ( Fig.12 and Fig.16 not shown).

[0222] Once the reservoir 222 has been inserted and guided into the housing 211, preferably until the reservoir abuts a stopper in the housing, the reservoir inlet 222a is aligned with the channel 211c in the housing. The stopper in the housing may be formed by a protrusion or raised structure on the housing abutting a portion of the reservoir.

[0223] In order to establish a fluid path from the outside to the reservoir inlet 222a and ensure fluid tightness at a specified pressure (such as the filling pressure), the fill port assembly includes at least one seal. Fig.16 In the embodiment shown in FIG. 1 , the filling 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 filling port seal 231 includes a flange 231a connected to a pierceable septum 231c ( Fig.14 ) of a cylindrical section 231f. When the fill port seal has been inserted into the passage 211c, the axis of the cylindrical section 231f is aligned with the axis of the inlet 222a of the reservoir. The flange 231a has a lateral dimension that fits tightly into the second recessed section 211d of the housing 211, while the pierceable septum 231c fits tightly into the inlet 222a of the reservoir. The flange 231a is disc-shaped and has a conical opening 231g for accessing the hole 231b that terminates in the pierceable septum 231c. The flange 231a fits into the disc-shaped second recessed section 211d in the housing. The cylindrical section 231f forms a hole 231b that is suitable for receiving a sleeve 235c of an insert 235 (see below). The inlet of the fill port seal 231 starting from the flange is conical and is suitable for receiving the insert 235 ( Fig.13 ) conical opening 235a. The longitudinal axis of the cone of the insert coincides with the longitudinal axis of the inlet of the reservoir. In this example, the filling port seal 231 is made of both an elastomer and a thermoplastic polymer. Alternatively, only an elastomer is used. The flange 231a and the outer surface of the cylindrical section 231f are made of elastomer so 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 filling port seal 231 is made of a thermoplastic polymer to provide mechanical strength to the filling port seal 231. The filling port seal 231 is Fig.14 The fill port seal is inserted into the Fig.15 The fill port seal 231 is preferably made using 2-component injection molding using a rigid thermoplastic 231d such as PBT and a soft elastomer 231e such as polysiloxane liquid silicone (LSR) rubber.

[0224] exist Fig.11 1 shows a cross section of a fill port seal 231 inserted into a channel 211c in a bottom wall 211g of a housing. The distal surface of the flange 231a contacts the proximal surface of a second recessed section 211d of the housing (see FIG. Fig.12 Optionally, the housing includes a protruding rim 211j that contacts the flange 231a of the filling port seal 231. The distal end of the cylindrical section 231f of the filling port seal 231 ( Fig.14 ) has an inlet 222a higher than the reservoir ( Fig.12 ) of the inner dimension so that the distal end is radially compressed as it enters the reservoir, thereby sealing the fill port seal with the reservoir inlet 222a ( Figure 9b ) establish a second seal 239. The second seal 239 is radially oriented perpendicular to the axis of the inlet of the reservoir. Optionally, the distal end of the cylindrical section and / or the pierceable septum 231c forms an axial seal with the surface of the inlet of the reservoir.

[0225] Fig.16 The exploded view of 211 shows how the fill port seal 231 and insert 235 are inserted into the channel 211c of the housing. Fig.10 A cross section of the filling port assembly is shown in this state before fixing. The insert 235 is made of metal (stainless steel Cr-Ni steel, such as AISI 305) and comprises a conical opening 235a connecting a base 235b to a sleeve 235c (see also Fig.13 ). The conical opening 235a fits into the cone formed by the thermoplastic polymer 231d of the filling port seal 231. The sleeve 235c fits into the hole 231b of the seal for guiding the needle toward the pierceable septum 231c. The base 235b of the insert includes a cutout 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 ( Fig.10 The insert 235 is fixed to the housing by heat-caulking the fixing pin 211e, thereby heating and deforming the fixing pin 211e ( Figure 9bDuring the fixing of the insert 235, the flange 231a of the filling port seal 231 is axially compressed between the base 235b of the insert and the bottom wall 211g of the housing. Optionally, the flange is locally compressed by a protruding rim 211j present in the second recessed section 211d in the housing ( Fig.11 ). Due to the compression of the flange, a first seal 238 is formed which is axially displaced from the second seal 239. The first seal 238 and the second seal 239 are established by the filling port seal and bridge the gap between the inlet of the reservoir 222 and the housing 211 and prevent leakage from the reservoir into the housing and the outside ( Figure 9b ). In addition, the first seal 238 and the second seal 239 prevent contaminants from the outside from entering the drug delivery device or entering the reservoir. When the insert is fixed to the housing, the lateral movement of the reservoir 222 relative to the housing may also be restricted or even act as a shock absorber for the reservoir. The inlet 222a of the reservoir is connected to the housing via the filling port seal 231 and the insert 235, and the elastomeric material of the filling port seal 231 can act as a buffer or shock absorber between the rigid reservoir and the rigid housing.

[0226] exist Fig.16 A method for assembling a drug delivery device or a portion of a drug delivery device is shown in FIG. The reservoir 222 is inserted into the opening of the housing along the longitudinal axis 222e of the reservoir. The plunger 221 may already be present in the reservoir ( Figure 9b ) or inserted into the reservoir after the reservoir is positioned inside the housing 211. Preferably, the wall of the reservoir is reinforced with a number of reinforcing ribs 222f, which are also suitable for facilitating the orientation and guidance of the reservoir in 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 interior surface of the housing may have longitudinal ridges for correctly guiding the reservoir to its final position. In a subsequent step, the filling port seal 231 and the insert 235 are inserted into the channel 211c in the housing along the axis defined by the conical opening 235a of the insert (or the conical opening of the filling 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 insertion of the fill port seal, the distal end of the fill port seal enters the inlet 222a of the reservoir to establish the second seal 239. During the securing of the insert (preferably by heat staking the securing pin 211e), the first seal 238 is established. Before, during or after insertion into the reservoir, the mixing assembly 240 is also inserted into the housing.

[0227] Another group of preferred embodiments illustrates the fourth aspect of the present invention. They are based on the above described Figure 1 and Figure 2a , Figure 2b The wearable semi-disposable patch pumps shown in . They are further described in the following paragraphs.

[0228] The reservoir outlet seal is improved by a design that is particularly cost-effective to manufacture.This advantageous design has been described in the context of the third aspect of the invention, wherein the reservoir outlet seal is combined with an improved filling port. Fig.18 An additional way to improve the reservoir outlet seal is shown. Figure 1 A reservoir unit with a portion of the housing removed, followed by a more detailed cross-section of the reservoir outlet ( Fig.19 ). The reservoir 222 has a rigid structure forming a reservoir outlet 222c. In this example, the reservoir outlet has a substantially cylindrical reservoir outlet seal cavity 222d. During manufacturing, the reservoir outlet seal cavity 222d is closed by inserting a substantially cylindrical reservoir outlet seal 223 made of a soft, fluid-tight but pierceable material (such as silicone or any kind of rubber), thereby establishing a fluid-tight closure of the reservoir outlet seal cavity 222d. In a separate manufacturing step, the reservoir outlet seal 223 is pierced by the input portion of the needle assembly. In the current example of the embodiment, the input portion of the needle assembly includes an input portion of the rigid sleeve 258. The result is a fluid-tight connection between the outlet of the reservoir and the needle assembly. Unlike a membranous seal, the substantially cylindrical shape of the reservoir outlet seal and therefore the reservoir outlet seal cavity provides significantly improved fluid impermeability, in this example up to a specified filling pressure of 6 to 8 bar. A wide range of variations of this embodiment are possible within the scope of the present invention. The reservoir outlet seal cavity and the reservoir outlet seal may be only partially cylindrical or have completely different shapes, while keeping the contact area between the reservoir outlet seal cavity and the reservoir outlet seal large enough 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 the reservoir outlet seal into the reservoir outlet seal cavity. More variations are produced by applying improvements to the outlet port seal to the reservoir outlet. All of the features described in accordance with aspect 4 of the invention (for example, reducing the number of parts by applying double-shot injection molding technology, or improving manufacturability by introducing an outlet port seal plug cavity that intersects with the outlet port opening) also produce variations of the embodiments described for the reservoir outlet.

[0229] Another group of preferred embodiments illustrates the fifth aspect of the present invention. They are based on the above described Figure 1 and Figure 2a , Figure 2b The wearable semi-disposable patch pumps shown in . They are further described in the following paragraphs.

[0230] exist Fig.18 In the Figure 1 1. The reservoir unit 200 of FIG. 1 is shown in FIG. 1 , wherein a portion of the housing is removed, in particular, the rigid sleeve 258 and the flexible sleeve 259 which are the main components of the needle assembly in this embodiment are exposed. Fig. 20 A cross-section of the needle assembly at the interface between the rigid cannula 258 and the soft cannula 259 is shown. The rigid cannula 258 has a substantially tubular shape and is configured to slide axially in the soft cannula lumen 259a of the soft cannula while maintaining a fluid-tight seal connection at the proximal input end of the soft cannula 259. In order to achieve fluid-tightness up to a specified filling pressure of 6 to 8 bar, the soft cannula has a soft cannula input seal portion 259b, wherein the material of the soft cannula 259 is deformed, thickened or otherwise altered to increase the compression of the soft cannula on the surface of the rigid cannula. The cannula input seal portion 259b of the soft cannula 259 can be formed by injection molding, by applying heat and / or mechanical pressure from outside the needle assembly, or by thickening and / or deforming the soft cannula 259 by other means during the manufacture of the needle assembly or during a later manufacturing step of the pump. While the most preferred location for the cannula input seal portion 259b is just at the proximal input of the flexible cannula 259, variations of this embodiment are possible where the flexible cannula input seal portion 259b is further toward the output end of the flexible cannula 259. Further variations may provide the flexible cannula input seal as a separate component from the flexible cannula.

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

[0232] The outlet port is improved by reducing the number of components at the interface by integrating one or more initially separate components into a unitary component. Fig.21aA schematic overview of the concept applied at the outlet port of a drug delivery device is given. The housing of the pump is shown as having: a first housing part 213 surrounding an outlet port opening 213a; and two other housing parts 214, which are connected to the first housing part 213 via housing seals 215. The combination of housing parts (both the housing part of the pump unit and the housing part 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 other sealing elements suitable for the intended use and connected to achieve the intended use. An outlet port assembly 261 including a rigid outlet port seal holder 262 and a soft outlet port seal 263 is installed at the outlet port opening 213a of the housing. In order to support the manufacturing process of the patch pump, the rigid outlet port seal holder 262 not only fixes the soft outlet port seal 263 in place for closing 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 pipes, curved pipes, 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 shape of the rigid outlet port seal holder is tubular, which defines an outlet port channel 262a that is at least partially tubular with an axis 262b.

[0233] A rigid outlet port seal holder 262 is attached to one of the housing components (at Fig.21a The soft outlet port seal 263 is installed at the outlet port opening 213a to seal the outlet port opening in a fluid-tight manner, while the rigid outlet port seal holder 262 and the housing (in Fig.21aA fluid-tight seal is established between the first housing component 213 in the figure. This has the following advantages: the connection between any housing component and the rigid outlet port seal holder 262 does not need to be fluid-tight at all. The fluid-tight requirement for the outlet port is fully guaranteed by the soft outlet port seal, which can be designed to withstand the specified pressure (whether it is ambient pressure, blocking pressure or filling pressure). The soft outlet port seal 263 is made of a soft and elastic material, such as an elastomer (such as silicone rubber) or any other fluid-tight material, which 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-tight seal at a specified fluid pressure. Other examples of such elastomers can be EPDM rubber, polydimethylsiloxane rubber PDMS (preferably, in the form of LSR) or elastomeric polyurethane (PUR) or thermoplastic elastomer (TPE). Soft outlet port seal 263 is attached to rigid outlet port seal holder 262 during manufacturing to form a fluid-tight connection, such as by double shot injection molding, by press fit or by any other means of fixing the seal to achieve the intended use. The process of manufacturing the patch pump of this embodiment includes the step of rigid outlet port seal holder being attached to housing while closing the outlet port opening and the step of piercing the soft outlet port seal by the output portion 260b of needle assembly 260. Because the output portion of 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 rigid cannula. The order of 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 in the housing of the drug delivery device. Because the soft outlet port seal has two sealing functions, the step of rigid outlet port seal holder being attached to housing can be identical with the step of attaching the soft outlet port seal to the rigid outlet port seal holder.

[0234] 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: sealing the housing to a rigid outlet port seal holder, sealing the output portion of the needle assembly to the rigid outlet port seal holder, and fluid-tightly closing the outlet port opening.

[0235] A further improvement of the outlet port concept of the present invention is achieved by modifying the shape of the housing of the drug delivery device and by introducing a recess in the region of the outlet port. Figure 21b The schematic overview of Fig.21aLike parts in the pump are numbered the same. The recess in the housing forms the outlet port chamber 213b, and the outlet port opening 213a is now located far enough inside the pump's envelope surface 1a to keep the output portion 260b of the needle assembly 260 completely inside. This arrangement has the advantage of protecting the output portion of the needle assembly from inadvertent physical contact with the environment, contamination or damage, while at the same time protecting the user and / or patient from inadvertent contact with the output portion of the needle assembly and thereby reducing the risk of injury from punctures.

[0236] 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 the components of the outlet port assembly, the rigid outlet port seal holder and the soft outlet port seal into one integral component. Fig.22a , Figure 22b A preferred embodiment of the group is illustrated. Fig.22a The outlet port assembly 261 is shown in perspective view (left) and cross-section view (right). The outlet port assembly 261 is manufactured as one integral part (e.g., by two-shot injection molding), wherein the rigid outlet port seal retainer 262 and the soft outlet port seal 263 are injected in separate shots using different materials as defined by the design described above. Alternatively, the outlet port assembly 261 can be pre-manufactured by attaching the two parts (e.g., by gluing), by applying a press fit, or any other technique that results in a fluid-tight connection between the two parts. Fig.22a , 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 Shown in fully assembled state for use Fig.22a The patch pump in an embodiment of the outlet port assembly includes a needle assembly 260 having an output portion 260b.

[0237] In a second group of embodiments according to the sixth aspect of the invention, the outlet port is modified by combining the outlet port assembly with one of the components of the housing into an integral component. Fig.23a -c illustrates one of many possible preferred embodiments for this group. Fig.23aThe first housing part 213 is shown in perspective with all soft parts attached, cut along the outlet port channel axis. The first housing part 213 is manufactured as an integral part, for example by two-shot injection molding with a soft material and a rigid material. The rigid outlet port seal holder 262 is an element of the first housing part 213, made of a rigid material and manufactured, for example, in a first shot of injection molding. The soft outlet port seal 263 is injected, for example, in a second shot of injection molding using a soft material as described above. The material can be selected to match the requirements of the drug delivery device, in particular fluid impermeability at a pressure specified for the outlet port. A particular advantage of this group of embodiments is that not only the rigid outlet port seal holder can 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 part that require a soft material. Fig.23a and Figure 23b 2, the multiple sealing functions of the soft outlet port seal are clearly visible: the seal does not only cover the open distal end of the outlet port channel 262a, but also includes the housing seal 215 in the housing that is designed for other purposes. The channel made of soft material can connect different sealing elements to improve manufacturability. Within the limits of manufacturability, any kind of housing parts can be realized, which integrates the outlet port assembly with other housing elements, as described in the present invention. Figure 23b yes Fig.23a 26 is a cross-section of the outlet port assembly to illustrate the shape of the soft outlet port seal 263 when closing the distal end of the outlet port channel 262a. Fig.23c Shown in fully assembled state for use Fig.23a The patch pump in an embodiment of the outlet port assembly includes a needle assembly 260 having an output portion 260b.

[0238] In a third group of embodiments according to the sixth aspect of the invention, the outlet port is improved by keeping the soft outlet port seal as its own component and by improving manufacturability (by introducing an outlet port seal plug cavity configured to allow easy insertion of the soft outlet port seal). With this approach, there is no need to make an additional component as a rigid outlet port seal holder; the rigid outlet port seal holder is therefore integrated into the housing component.

[0239] Fig.24a -d illustrates a preferred embodiment of this group. Fig.24aThe first housing component 213 is shown in a perspective view (left) and a cross-sectional view (right). The first housing component 213 is manufactured as an integral component (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 soft 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 retainer 262 has an outlet port seal 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. Fig.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 on the axial end. The 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 provide a fluid-tight seal of 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 face of the outlet port sealing plug cavity while closing the outlet port opening 213a in a fully assembled state. Two figures are added to further explain the shape of the outlet port sealing plug cavity of this embodiment group. Figure 24b 2 is a perspective view of the first housing component 213 with the rigid outlet port seal retainer 262 cut along the outlet port passage axis to illustrate the shape of the outlet port seal plug cavity 213c. Fig.24c In , the same view is shown, but with the soft outlet port seal inserted into the rigid outlet port seal cavity. Fig.24a-d example, both outlet port sealing plug cavity 213c and soft outlet port seal 263 have the shape of cylinder basically, and one section is cut off.This shape is advantageous, because soft outlet port seal can be inserted into rigid outlet port seal holder like cylindrical plug, and flat side provides better fixation during piercing step.The minimum angle between outlet port sealing plug cavity 213c and the axis of outlet port passage promotes the manufacturing step of piercing outlet port seal with the output part 260b of needle assembly 260.The other advantage of the angle between outlet port sealing plug cavity axis and outlet port passage axis is: when the output part of needle assembly pierces soft outlet port seal, described soft outlet port seal is held in place by rigid outlet port seal holder 262, and shear force or pulling force is hardly produced or not produced at the connection between soft outlet port seal and rigid outlet port seal holder, which improves sealing again to reliably meet the fluid impermeability requirement as specified.

[0240] Fig.24d Shown in fully assembled state for use Fig.24a -c, the patch pump comprising a needle assembly 260 having an output portion 260b.

[0241] Fig.25a -e illustrates something like Fig.24a Another preferred embodiment group of the embodiment group in -d. Fig.25a The first housing component 213 is shown in perspective view (left) and in cross-section (right). As before, the first housing component 213 is manufactured as one integral component (e.g., by injection molding) and may also integrate other components (such as the housing seal 215). The rigid outlet port seal holder 262 is an element of the first housing component 213 and is made of a rigid material. The soft outlet port seal 263 is manufactured as a separate component, for example, by injection molding using a different mold. Still like Fig.24a -d, the element of the first housing component corresponding to the rigid outlet port seal holder 262 has an outlet port seal plug cavity 213c, which is located at Fig.25aThe outlet port seal plug cavity is filled with a soft outlet port seal 263. The outlet port seal plug cavity with the outlet port seal plug cavity axis 213d still intersects with 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 embodiment group, the outlet port seal is no longer a stopper in the shape of a cylinder, but can have any other shape suitable for being pressed into the outlet port seal plug cavity through at least one open side. In this embodiment group, the outlet port seal cavity axis no longer implies rotational symmetry, but indicates the path along which the soft outlet port seal is inserted into the rigid outlet port seal holder. Pushing the wide seal a short distance into the cavity - this can be regarded as the sideways assembly of the stopper - is significantly easier than axially pushing the cylindrical seal, and brings significant improvements in manufacturability. This group of embodiments has the following additional advantages: the outlet port seal plug cavity can be designed to have a variety of shapes, particularly adding a narrowing or flattening portion around the open distal end of the outlet port passage to increase compression and optimize fluid impermeability and penetration in this area without compromising easy assembly during manufacturing. For sideways insertion, the shape of the outlet port seal 263 is preferably not like a cylinder, but more like a bumper or tablet, such as Fig.25d (left). Two figures are added to further explain the shape of the outlet port sealing plug cavity of this embodiment group. Fig.25b 2 is a perspective view of the first housing component 213 with the rigid outlet port seal retainer 262 cut along the outlet port passage axis to illustrate the shape of the outlet port seal plug cavity 213c. Fig.25c , the same view is shown, but with the soft outlet port seal inserted into the rigid outlet port seal cavity. Fig.25d Shows the insertion into Fig.25b FIG. 2 is a diagram of a flexible outlet port seal 263 before (left) and after (right) in an outlet port seal plug cavity 262. It can be clearly seen that in the arrangement as described, the flexible outlet plug seal 263 is elastically deformed and compressed due to the insertion, wherein the flat surfaces are at a substantially orthogonal angle when the output portion of the needle assembly will pierce the seal.

[0242] Fig.25e Shown in fully assembled state for use Fig.25a -e outlet port assembly, the patch pump includes a needle assembly 260 having an output portion 260b.

[0243] Another group of preferred embodiments illustrates the seventh aspect of the present invention. They are based on the above described Figure 1 and Figure 2a , Figure 2b The wearable semi-disposable patch pumps shown in . They are further described in the following paragraphs.

[0244] The patch pump is further modified by covering the outlet port chamber 213b with a semi-permeable outlet port cover 285 that is removably attached to a component of the patch pump housing 214, such as Fig.26a -c. The outlet port cover 285 is configured to allow air to pass through, while any fluid (such as, for example, water or fluid medicament) is blocked or prevented from entering or leaving the outlet port chamber 213b. In the case of such an outlet port cover, the needle assembly 260 and the reservoir 222 can be filled with medicament from the outside without any fluid contacting the patient. During the filling of the reservoir 222 and / or the perfusion fluid path by the needle assembly 260, the air initially present in the fluid path and / or in the outlet port chamber is at least partially pressed through the outlet port cover and replaced with fluid. However, the fluid is blocked by the outlet port cover. This has the following two advantageous effects: first, as mentioned above, when the outlet port cover is in place, no drug overflows through the outlet port; second, the outlet port cover 285 closes the fluid path and ensures that the filling pressure required to move the plunger 221 and fill the reservoir can be applied to the fluid. By supporting the process of filling the reservoir and / or perfusing the fluid path, the outlet port cover of the present invention has made a significant contribution to the safe and reliable operation of the drug delivery device. The outlet port cover is implemented using a priming membrane 285a made of a semi-permeable material, preferably in the form of a sheet, 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 Fig.26a The membrane reinforcement structure can be, for example, a plastic ring, a mesh, a net or a sheet of textile material that is strong enough to allow the outlet port cover to be removed without damaging the cover and is configured to allow fluid to contact the primer membrane. The membrane reinforcement structure 285b is removably attached to the housing part 214, for example by means of glue or double-sided tape. The double-sided tape can even be the same as the membrane reinforcement structure 285b, wherein the first side is permanently adhered to the primer membrane 285a and the second side is removably adhered to the housing part 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 easy handling of the pump.

[0245] In this basic embodiment, the outlet port cover 285 further includes an outlet port cover liner 285c, which is permanently fixed to the membrane reinforcement structure 285b but is not attached to the housing part 214. Using the outlet port cover liner 286, after successfully filling and / or priming the patch pump, the outlet port cover 285 can be easily removed from the housing 214. Since filling and priming are not functions that only exist in patch pumps, the concept of the outlet port cover can be advantageously applied to all kinds of drug delivery devices.

[0246] In order to achieve the best state of accuracy and reliability, it is particularly important for the patch pump to have the area surrounding the output portion of the needle assembly well attached to the patient's body (ideally with a fluid-tight connection) during drug delivery. The outlet port concept with an outlet port cover is further improved by bringing the edge of the adhesive layer that provides this fluid-tight connection closer to the outlet port. This is achieved by integrating the outlet port cover into the adhesive patch assembly. In Figure 26b In the preferred example of this embodiment is shown. The outlet port cover 285 still includes a primer film 285a and a film reinforcement structure 285b. In order to make the adhesive patch assembly 280 as close as possible to the boundary of the outlet port chamber 213b, a film bearing structure 212e is introduced. The film bearing structure is permanently attached to the housing part 214, preferably integrated therein as an element of the same integral part. The film bearing structure has a thickness substantially the same as the adhesive patch assembly 280, and is shaped to surround the outlet port chamber in such a way that as long as the outlet port cover 285 is attached to the housing, a fluid-tight connection is formed between the housing 214 and the outlet port cover 285. A very simple example is a plastic ring that is integrated in the housing part 214 or permanently attached to the housing part 214. In this embodiment, the adhesive patch assembly 280 has an adhesive layer 280a and an adhesive release liner 280b. With the membrane supporting structure 212e in place as described, the membrane reinforcing structure can remain in substantially the same plane while being removably attached to the membrane supporting structure 212e and permanently secured to the adhesive release liner 280b. As previously described, the primer film 285a is permanently secured to the membrane reinforcing 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 cover liner (285c, see Fig.26a ) brings further cost advantages and brings the best of ease of use. The outlet port cover 285 can be simply removed from the outlet port chamber 213b by removing the adhesive release liner 280b from the adhesive layer 280a - a task that the user must do anyway to attach the patch pump to the patient's body. Fig.26cA possible embodiment of an adhesive patch assembly 280 combined with an outlet port cover 285 as described is shown. A primer film 285a is mounted on an adhesive release liner 280b using a double-sided adhesive ring, which also serves as a membrane reinforcement structure 285b. Adhesive mounting tape 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 many adhesive cutouts 280c are introduced in the adhesive layer 280a, preferably all layers of the adhesive patch assembly 280 are cut through to allow access to the pump housing to achieve functions such as filling a reservoir, bringing a needle assembly to a position for drug delivery or pressure compensation.

[0247] Further improvements to the outlet port cover within the scope of the present invention include combinations of the outlet port cover and / or the membrane bearing structure with any other element on the pump housing or combinations of the outlet port cover concept with other functions. As an example of such extended functionality, the attachment of the outlet port cover can be designed to break free at low fluid pressures, thereby intentionally allowing leakage to indicate to the user that the filling of the reservoir has been successfully completed, or to indicate to the user that the maximum pressure has been exceeded.

[0248] Another group of preferred embodiments illustrates the eighth aspect of the present invention. They are based on the above described Figure 1 and Figure 2a , Figure 2b The wearable semi-disposable patch pumps shown in . They are further described in the following paragraphs.

[0249] The patch pump is further improved by introducing a number of ventilation channels at the interface between the patch pump and the patient's body. These ventilation channels allow air and moisture to exit 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. Although similar ventilation channels are known, the combination with other aspects of the present invention produces Fig. 27 The new solution shown in . As previously described, it is advantageous for a patch pump to have the area surrounding the output portion of the needle assembly well attached to the patient's body (ideally with a fluid-tight connection) during drug delivery. Therefore, in an embodiment of the present invention, the ventilation channel is not connected to the outlet port chamber, but only begins at a distance that is large enough for the adhesive patch assembly to ensure such a fluid-tight connection, but small enough to improve adhesion in that area of ​​the adhesive patch assembly. The preferred distance range is 1 mm to 20 mm, most preferably 5 mm to 10 mm. In Fig. 27In a preferred embodiment of the invention, the ventilation channel is implemented as a ventilation groove 212f in the base plate 211a of the reservoir unit 200. This example of embodiment also includes a membrane bearing structure 212e. Thus, the adhesive layer covers the complete base plate 211a including the base plate extension 212c, with cutouts for the outlet port and for the membrane bearing structure 212e. Fig. 27 It is clearly visible that the ventilation groove 212f is arranged at a distance from the edge of the membrane supporting structure 212e. When the adhesive patch assembly (not shown) is installed on the base plate 211a, the ventilation groove is covered by the adhesive patch assembly, thereby 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 out from there into the environment outside the patch pump. Fig. 27 It is also clearly visible in the figure that these ventilation channels are not connected to the outlet port chamber 213b. It is obvious that the shape or number of the ventilation channels is not important to their intended function. Although Fig. 27 The ventilation channels in the embodiment are implemented as two substantially straight semi-cylinders, but they may have any other geometric shape, size, arrangement or placement 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.

[0250] The result is a patch pump that has improved ventilation at the interface between the base of the pump and the patient's body while still allowing for an optimal state of fluid-tight connection between the two sides of the interface surrounding the outlet port chamber, resulting in improved accuracy and reliability of drug delivery. Again, the arrangement of the present invention allows the housing of the pump and the adhesive patch assembly to be designed to achieve fluid-tightness at the minimum fluid pressure specified for the interface.

[0251] Although the present invention has been described in detail in the drawings and the foregoing description, such description will be considered to be illustrative or exemplary rather than restrictive. By studying the drawings, the disclosure and the appended claims, those skilled in the art can understand and implement variations of the disclosed embodiments when practicing the claimed invention. Considering that the nature of the present invention has many aspects that contribute to the overall optimal state, it is obvious to those skilled in the art that, for the sake of better clarity, improvements described as different aspects can be applied in any selection and / or combination. For example, the solution provided for the improved outlet port seal can be well used to improve the filling port or any other seal in the drug delivery device. The filling port assembly can be combined with the outlet port assembly to further optimize the pump. In the claims, the word "including" does not exclude other elements or steps, and the indefinite article "one" or "an" does not exclude multiple. The mere fact that certain elements or steps are described in different claims does not indicate that the combination of these elements or steps cannot be used to benefit, and specifically, any further meaningful claim combination should be considered to be disclosed in addition to the actual claim dependency.

[0252] Reference numerals list

[0253] 1 Patch Pump

[0254] 1a Encapsulation surface

[0255] 100 Pump Units

[0256] 113 Locking mechanism

[0257] 113a Locking spring

[0258] 114 Open side

[0259] 120 driving mechanism

[0260] 122 Plunger rod

[0261] 123 Plunger rod cap

[0262] 125 Threaded rod

[0263] 140 System control circuit

[0264] 141 Printed Circuit Board, PCB-PU

[0265] 142 Connecting pin

[0266] 150 Rechargeable batteries

[0267] 151 Battery contacts

[0268] 200 Storage Units

[0269] 211 Reservoir unit housing

[0270] 211a Base plate

[0271] 211b Wall

[0272] Channel 211c

[0273] 211d First concave section

[0274] 211e Fixing pin

[0275] 211f Second concave section

[0276] 211g bottom wall

[0277] 211h Sidewall

[0278] 211i Top Wall

[0279] 211j Raised edge

[0280] 211k Stable concave

[0281] 211m Cut

[0282] 212a Bayonet connection

[0283] 212b Rotation axis

[0284] 212c Base plate extension

[0285] 212d Locking structure

[0286] 212e membrane bearing structure

[0287] 212f Ventilation grooves

[0288] 212g inner end

[0289] 212h External

[0290] 213 first housing component

[0291] 213a Outlet port opening

[0292] 213b Outlet port chamber

[0293] 213c Outlet port sealing plug cavity

[0294] 213d Axis of the cavity of the outlet port sealing plug

[0295] 214 Shell parts

[0296] 215 Housing seal

[0297] 216 Pressure compensation membrane

[0298] 221 Plunger

[0299] 222 Storage

[0300] 222a Reservoir inlet

[0301] 222b Stable protrusion

[0302] 222c Reservoir outlet

[0303] 222d Reservoir outlet seal cavity

[0304] 222e Reservoir axis

[0305] 222f Reinforcement rib

[0306] 222g Fill port seal cavity

[0307] 223 Reservoir outlet seal

[0308] 230 Fill port assembly

[0309] 231 Fill port seal

[0310] 231a Flange

[0311] 231b hole

[0312] 231c Pierceable Diaphragm

[0313] 231d Thermoplastic polymers

[0314] 231e Elastomer

[0315] 231f Cylindrical section

[0316] 231g Conical opening

[0317] 235 Needle Guide / Insert

[0318] 235a Conical opening

[0319] 235b Base

[0320] 235c sleeve

[0321] 235d Opening or incision

[0322] 238 First seal

[0323] 239 Second seal

[0324] 240 Mixing components

[0325] 241 Base frame

[0326] 243 Printed Circuit Board, PCB-RU

[0327] 244 Batteries

[0328] 245 Battery opening

[0329] 246 Holding element

[0330] 250 Inserter Assembly

[0331] 251 Casing moving assembly

[0332] 252 Insert Spring

[0333] 253 Flexible Casing Holder

[0334] 254 Rigid Casing Holder

[0335] 256 Insert Trigger

[0336] 258 Rigid casing

[0337] 259 Soft casing

[0338] 259a Soft cannula lumen

[0339] 259b Flexible sleeve seal, input section

[0340] 260-pin assembly

[0341] 260a Input section

[0342] 260b Output Section

[0343] 261 Outlet Port Assembly

[0344] 262 Rigid Outlet Port Seal Retainer

[0345] 262a Egress Port Channel

[0346] 262b Outlet port channel axis

[0347] 263 Soft outlet port seal

[0348] 270 Connector Structure

[0349] 271a-271d Connector components

[0350] 272 Contact Arm

[0351] 272a First electrical contact region

[0352] 272b Second electrical contact region

[0353] 273 Switch Arm

[0354] 274 First battery contact arm

[0355] 274a First battery contact area

[0356] 275 Second battery contact arm

[0357] 275a Second battery contact area

[0358] 280 Adhesive patch components

[0359] 280a Adhesive layer

[0360] 280b Adhesive release liner

[0361] 280c Adhesive Cutout

[0362] 285 Outlet port cover

[0363] 285a Primer film

[0364] 285b Membrane reinforced structure

[0365] 285c Outlet port cover lining

[0366] 290 Non-conductive body

[0367] 291 First Opening

[0368] 292 Second Opening

[0369] 293 Fixing pin

[0370] 294 Support pin

[0371] 295 Upper rail

[0372] 296 Lower rail

[0373] 297 End stop surface

[0374] 300 patients.

Claims

1. A drug delivery device for delivering a medicament from a reservoir (222), comprising: a housing (211) comprising a wall (211b) separating an interior volume from an exterior; a reservoir (222) located within the interior volume; a fill port assembly (230) located in the wall (211b) of the housing (211) and accessible from the exterior for filling the reservoir (222); The fill port assembly (230) includes a conical opening (235a) for receiving a needle and a pierceable fill port seal (231) separating the reservoir (222) from the exterior; Characterized in that the fill port assembly (230) includes an insert (235) adapted to be received by a channel (211c) in a wall (211b) of the housing (211), and wherein the fill port seal (231) provides a seal (238, 239) between the housing (211) and the reservoir (222), wherein the insert (235) and the fill port seal (231) mechanically secure the reservoir (222) relative to the housing (211).

2. The drug delivery device according to claim 1, wherein: The insert (235) includes a conical opening (235a) extending from a base (235b).

3. The drug delivery device according to claim 2, wherein: The fill port seal (231) is sandwiched between a base (235b) of the insert (235) and a wall (211b) of the housing (211) to provide a first seal (238) between the insert (235) and the housing (222).

4. The drug delivery device according to claim 3, wherein: The fill port seal (231) includes a flange (231a) adapted to be received in a recessed section (211d) of a channel (211c) in a wall (211b) surrounding the housing (211) to form the first seal (238) as an axial seal between a base (235b) of the insert (235) and the housing (211) along the longitudinal axis of the conical opening.

5. The drug delivery device according to claim 3 or 4, wherein: The fill port seal (231) seals the inlet (222a) of the reservoir (222).

6. The drug delivery device according to claim 5, wherein: The filling port seal (231) provides a second seal (239) between the filling port seal (231) and the inlet (222a) of the reservoir (222), the second seal being oriented in a radial direction perpendicular to the longitudinal axis of the conical opening, and wherein the second seal (239) is axially displaced from the first seal (238).

7. The drug delivery device according to claim 1, wherein: The fill port seal (231) includes a hole (231b) terminating in a pierceable septum (231c).

8. The drug delivery device according to claim 7, wherein: A sleeve (235c) extends from the conical opening (235a) of the insert (235), the sleeve being adapted to be received within the bore (231b) of the fill port seal (231).

9. The drug delivery device according to claim 8, wherein: An outer surface of the fill port seal (231) is received in the inlet (222a) of the reservoir (222).

10. A drug delivery device according to any one of the preceding claims, wherein: The insert (235) is made of metal.

11. A drug delivery device according to any one of the preceding claims, wherein: The fill port seal (231) comprises thermoplastic and elastomer.

12. A drug delivery device according to any one of the preceding claims, wherein: The insert (235) includes a recess or opening or cutout (235d) configured to receive a securing pin (211e) extending from a wall (211b) of the housing (211).

13. A method for assembling a drug delivery device according to claim 6, comprising the steps of: - providing the housing (211), the reservoir (222), the fill port seal (231) and the insert (235); - inserting the reservoir (222) from the outside into the housing (211) along an axis perpendicular to the cone axis; followed by - inserting the filling port seal (231) from the outside along the cone axis into the channel (211c) in the wall (211b) of the housing (211); followed by -Insert the insert (235) into the filling port seal (231) from the outside, thereby clamping the filling port seal (231) between the insert (235) and the shell (211), and establishing the first seal (238) and the second seal (239) and mechanically fixing the reservoir (222) to the shell (211) with the help of the insert (235) and the filling port seal (231).

14. The method according to claim 13, wherein: The insert (235) includes a recess or opening or cutout (235d) configured to receive a securing pin (211e) extending from a wall (211b) of the housing (211), the method further comprising the steps of: - positioning the recess or opening or cutout (235d) of the insert (235) on a fixing pin (211e) extending from the wall (211b) of the housing (211), and subsequently heat-staking the fixing pin (211e) to fix the insert (235) to the housing (211).

Images