Holding device, apparatus including the holding device, drug delivery device, and method
The holding device uses negative gas pressure and alignment structures to ensure correct orientation of objects, addressing the challenges of orientation verification in pick-and-place technologies, enhancing assembly accuracy and reducing costs.
Patent Information
- Application Number
- JP2025529220
- Authority / Receiving Office
- JP · JP
- Patent Type
- Applications
- Current Assignee / Owner
- Priority Date
- 2022-11-21
- Filing Date
- 2023-11-20
- Publication Date
- 2025-11-28
AI Technical Summary
Existing pick-and-place technologies face challenges in accurately orienting special objects like coin cells and objects requiring orientation, often necessitating expensive image processing to verify orientation during assembly.
A holding device with a retaining structure and alignment structure that utilizes negative gas pressure through openings to ensure correct orientation by interacting differently with objects based on their surface configurations, preventing hold in incorrect orientations.
Enables cost-effective and accurate orientation of objects during assembly, reducing the need for image processing and preventing assembly errors, ensuring proper electrical connections and device functionality.
Smart Images

Figure 2025538521000001_ABST
Abstract
Description
[Technical Field]
[0001] The present disclosure relates to a holding device that can be used to hold an object during device assembly. Pick-and-place technology is widely used, for example, to assemble electronic devices. Typically, a suction head is used that is positioned at the center of an object, such as an IC (integrated circuit) or discrete electronic component. Surface-mounted devices (SMDs) and / or IC packages (e.g., those with lead frames) can be assembled to PCBs (printed circuit boards) or other circuit carriers by a pick-and-place machine. Soldering the PCB can be the next step to produce a complete PCBA (printed circuit board assembly) or other assembly. However, although pick-and-place technology has been used for a long time, limitations may exist for special objects, such as coin cells (button cells) and / or objects that require orientation. Expensive image processing may be required to verify or determine the orientation of these objects during automated pick-and-place. Summary of the Invention [Problem to be solved by the invention]
[0002] An object of the present disclosure can be to provide an improved holding device. Preferably, the holding device should be able to ensure correct orientation of an object, for example during manual or automated assembly. Furthermore, a corresponding article and a corresponding method should be provided. [Means for solving the problem]
[0003] This object is solved by a holding device according to claim 1. Further embodiments are set forth in the dependent claims.
[0004] According to one embodiment, a holding device for holding an object during assembly of a device, for example a medical device, comprises: - a retaining structure, and - Alignment Structure It may include at least one, some, or all of the following:
[0005] According to one embodiment, the holding structure may include at least one opening configured to provide a negative gas pressure, e.g., a suction gas flow, which may come from the environment surrounding the holding device and be directed to the opening.
[0006] According to one embodiment, the alignment structure may be configured to align the object with respect to the holding structure, e.g., laterally, which may enable positioning of the object with respect to the at least one opening, in particular a positioning that allows dedicated holding of the object by suction force applied through the at least one opening depending on the orientation of the object within the holding device.
[0007] According to one embodiment, an object can include a first side and a second side opposite the first side of the object. The first side can have a first surface configuration that is different from the second surface configuration of the second side. This can enable dedicated holding of the object, for example, by using the same gas flow that interacts differently with the two sides. The object can be, for example, a battery, particularly a non-rechargeable battery or a rechargeable battery. Another example of an object with two different surface configurations on opposite sides is a transistor in a plastic case, for example, a TO-92 (transistor outer periphery) package. Correct orientation of the device can be important, as failure to do so can result in destruction of the object and / or destruction of other components, particularly electronic components.
[0008] According to one embodiment, the at least one opening can be positioned to apply negative pressure to a first side of the object. The application of negative pressure to a second side can be prevented or reduced by a second surface configuration, for example, by a "macro" profile difference, for example, a profile difference of at least 0.5 mm (millimeter) or at least 1 mm. Alternatively or additionally, there can be a "micro" profile difference of the surface, for example, a profile difference of less than 0.5 mm (millimeter).
[0009] According to one embodiment, the holding device can be configured to hold the object using negative pressure only in a first orientation in which a first side of the object faces and / or may abut against the at least one opening, but not in a second orientation in which a second side faces the at least one opening. Thus, a dedicated hold is provided. The dedicated hold can be used to at least implicitly ensure correct orientation, e.g., the object is held in the holding device in the correct orientation but not in the wrong orientation.
[0010] According to one embodiment, the at least one opening may be at least one slit, e.g. at least one curved slit (arcuate), at least one straight slit, or at least one hole, e.g. at least one round hole (circular), at least one oval hole, etc. A combination of holes / slits of different shapes may also be used.
[0011] According to one embodiment, all openings may have the same shape, or different shapes or shapes with different extents may be used, for example to provide a uniform suction force.
[0012] The at least one abutment area may provide an area or surface for abutment of an object, for example, in the axial direction. The at least one opening may be located within the abutment area. Alternatively, the at least one opening may be located at a different position compared to the position of the at least one abutment area. The edge of the opening, for example, the entire edge or only a part of the edge, may be used as the abutment area.
[0013] According to one embodiment, the device may be a medical device, e.g., a drug delivery device, that includes electronic components or electronic modules for generating and / or storing data, e.g., digital data related to drug delivery. When the coin cell is applied to a medical device, ensuring the correct orientation (e.g., polarity) of the connections to the electronic circuitry may be critical to the life of the patient. The medical device may be a drug delivery device, e.g., an autoinjector, an electronic thermometer, a pacemaker, etc. However, correct polarity may also be important in other devices, e.g., key fobs for lock systems, remote control devices, etc., among others.
[0014] According to one embodiment, the negative pressure may be applied via a system including a pneumatic system, for example, a system that can be controlled by a control unit and / or an operator. It may therefore be possible to apply or stop the suction force, for example, by using a foot switch or other suitable switch. However, automatic release of the object from the holding device may also be used. When the negative pressure is turned off, the object may be released from the holding device in a simple manner. However, additionally or alternatively, other release methods may be used, for example, using a tool to remove the object from the holding device.
[0015] The object may be inserted manually into the holding device, insertion in the wrong orientation may for example prevent further transport of the object, however automatic insertion is also possible.
[0016] One technical effect of a holding device may be to enable selective holding and / or selective transport of an object in the correct orientation against gravity. In the wrong orientation, the holding force may not be strong enough and the object may fall out of the holding device due to gravity. Therefore, an object orientation selective holding device (ooshd) may be provided.
[0017] Different surface configurations may be achieved, for example, by different geometric shapes in the edge region and / or different surface structures and / or different sizes and / or different diameters in the case of a circular first surface and a circular second surface, as will be explained in more detail below. The first surface of the object and the second surface of the object may face in opposite directions.
[0018] The holding device may be configured to hold an object in the holding device when the first surface faces the holding structure, and not to hold an object in the holding device when the second surface faces the holding structure.
[0019] Image processing may no longer be necessary to detect the orientation of the object or may be used additionally, for example as a double check. Thus, a very simple and / or cost-effective solution for orienting an object is provided by the holding device. Errors of a human operator assembling the device, for example inserting an object, may be prevented. However, there may also be errors in automated production that may be prevented using the proposed holding device.
[0020] The use of gas / air can be cost effective compared to, for example, other complex mechanically operated holding devices and / or imaging processes.
[0021] According to one embodiment, the alignment structure may include at least one alignment region arranged to laterally align an object. The at least one alignment region may preferably be arranged adjacent to at least one opening to hold the object at at least one edge region of the object and / or to provide highly accurate lateral alignment. "Adjacent" may mean within 0.5 percent to 5 percent of the maximum lateral extension of the object. The at least one entrance opening may be arranged preferably near or adjacent to a lateral alignment surface of the alignment structure. The distance between the lateral alignment surface and the opening (e.g., the edge of the opening) may be less than 2 mm (millimeters) or less than 1 mm, and preferably greater than 0.5 mm, as a lower limit example.
[0022] The boundary or edge region of an object may be particularly suitable for achieving dedicated holding of an object having different edge regions on different sides, such as a coin cell, a transistor in a plastic housing, etc. Thus, an object may be held at the edge region in the correct orientation, but not or only poorly held in the central region, for example because the central region does not have a different surface configuration that allows for selective or dedicated holding of the object in the holding device.
[0023] According to one embodiment, the retaining structure may include at least one abutment area configured to abut the second side of the object, or alternatively, the first side and the second side of the object.
[0024] According to a first embodiment, the at least one opening may be arranged in a different position compared to the at least one abutment region. According to the first embodiment, the at least one opening may be covered only when the object is arranged in the holding device in a first orientation, but not when the object is arranged in the holding device in a second configuration.
[0025] Alternatively or additionally, at least one opening may be arranged in the at least one abutment region. According to a second embodiment, the at least one opening may be covered when the object is arranged in the holding device in a first orientation and may also be covered when the object is arranged in the holding device in a second configuration. In this case, different surface roughnesses may be used, for example, to achieve selective holding of the object only in the first orientation.
[0026] According to one embodiment, the different surface configurations may be achieved by at least one of the following features: a) the maximum lateral extent or diameter of the most prominent first surface of the first side of the object is greater than the maximum lateral extent or diameter of the most prominent second surface of the second side of the object. Preferably, the first surface may have a larger surface area than the second surface. b) the first surface of the first side of the object has a smaller surface roughness compared to the surface roughness of the second surface of the second side of the object. Preferably, the first surface may have a smoother surface profile compared to the second surface. c) A chamfered or rounded peripheral region on a first side of the object, while a second side of the object does not have such a chamfered or rounded peripheral region. The second side may have a relatively sharp edge, for example, compared to the edge of the chamfered or rounded peripheral region. The chamfer may preferably extend along the entire periphery. The rounding may be present not only in the circumferential direction but also in a cross section including the longitudinal axis and preferably also the radial axis of the object. Thus, rotation of the object is not an issue, and rotational alignment may not be necessary. However, the chamfer may also extend only to at least one region of the periphery of the object, and not to at least one other peripheral region of the object. Thus, for example, two chamfered or rounded peripheral regions may be present on the first side of the object, preferably at opposite lateral positions. d) Other physical properties suitable for interacting with a gas (e.g., air) flow through the at least one opening to achieve dedicated holding of the object depending on its orientation relative to the holding device.
[0027] According to one embodiment, the holding device may include at least one, a discretionary selection, or all of the following features: a) the abutment area is arranged to provide an abutment surface for the object in a first direction, preferably in the axial direction of the object, and the alignment structure may include at least one lateral retention surface or surface portion configured to align the object in a second direction different from the first direction; b) the holding device comprises a gas transport structure, which may comprise at least one channel or tube connected to or connectable to the at least one opening and configured to be connected to a negative pressure source;
[0028] According to one embodiment, the holding device may include a housing or casing. The holding and / or alignment structures may be provided on or within the housing. The housing may include at least a portion of the gas transport structure. "Provided" may mean that each structure may be an integral part of the housing or may be located on the housing, for example as a separate part. The gas transport structure is described below in other embodiments. The use of a housing may enable a compact holding device to be realized.
[0029] According to further embodiments, the housing may include at least one, some, or all of the following: a housing; - a cylindrical shell surface, the axis of rotational symmetry of which may define a longitudinal axis of the housing. - a circular proximal surface, and - It does not concern an annular or essentially annular distal surface, such as an air flow (leakage) recess as described herein.
[0030] The housing may include a cylindrical retaining space extending from, for example, an annular or essentially annular distal surface along the longitudinal axis of the housing to a circular abutment surface. The circular abutment surface may preferably be arranged coaxially with respect to the longitudinal axis of the housing. The cylindrical retaining space may be part of an alignment structure. The circular abutment surface may preferably include at least one opening of the pneumatic subsystem within a peripheral region. The circular abutment surface may be a flat surface.
[0031] According to a further embodiment, the housing may preferably include at least one lateral main channel extending radially and connected to the at least one opening, and the at least one main channel may be configured to be connected to at least one tube or hose, for example by inserting the tube or hose into an open end of the at least one main channel.
[0032] The cylindrical shell surface may extend from a circular proximal surface to an annular distal surface.
[0033] The housing may thus be adapted for assembly of an object, e.g., an essentially flat, cylindrically shaped object, into a medical injection device, in particular a pen device or a pen-shaped autoinjector. Illustratively, the cylindrical outer surface may allow for easy alignment of the holding device with a cylindrical housing of a drug delivery device or with a cylindrical housing of an electronic module configured to be, e.g., mechanically connected to the drug delivery device. The other technical advantages mentioned above may also apply to the housing.
[0034] According to one embodiment, the holding device may include a cylindrical holding space adapted to hold an object and delimited by holding and / or alignment structures. The diameter of the cylindrical holding space may be slightly larger than the maximum diameter of the object, for example, by up to 1 percent or up to 2 percent, but may be at least 0.5 percent larger than the diameter of the object, for example, to give a lower limit. The height of the cylindrical holding space may preferably be within a range from half the maximum height of the object to the maximum height of the object. Thus, inserting an object into the holding device may be simple. Furthermore, release of the object may be possible by switching on negative pressure and using gravity alone. However, it may also be possible to facilitate release by providing positive pressure through at least one opening and / or by using a separate tool. Because the cylindrical holding space may be complementary to the cylindrical outer shape of the object, the cylindrical holding space may be most suitable for cylindrical coin cell batteries. Using the cylindrical holding space, easy alignment, particularly in all lateral directions, may be possible. However, it is also possible to use separate ribs at the borders of the cylindrical holding space, or to use no cylindrical holding space at all, but ribs, for example three ribs or more than three ribs.
[0035] According to one embodiment, at least one first opening of the at least one opening can be located at a first location. At least one second opening of the at least one opening can be located at a second location. The first and second locations can be located on opposite lateral surfaces of the retaining structure. The first and second locations can correspond to opposite peripheral regions of the first side of the object.
[0036] Thus, the holding device may be configured such that exclusive holding of an object is achieved by blocking (e.g., closing or nearly closing) the first opening by the first peripheral region on the first side and at least the second opening by the second peripheral region on the first side. The first peripheral region may thereby not block or close the second opening. The second peripheral region may thereby not block or close the first opening. The "peripheral region" may refer to the outermost portion, for example, a portion in the range of 60 percent to 100 percent or 75 percent to 100 percent of the radius of the first side of the coin cell battery or other object and / or the storage space for the coin cell or another object within the holding device.
[0037] Preferably, the at least one first opening can be part of a first group of at least one opening. The at least one second opening can be part of a second group of at least one opening. This can make it possible to simply hold an object in the holding device by its opposite side (e.g., a disk-shaped object) or end (e.g., a bar-shaped object). When a group of openings is used, a larger holding area can be provided. This can provide a more secure hold and / or redundancy, for example, if one of the openings or holes is closed by dust or the like.
[0038] According to further embodiments, the holes may be arranged around the entire periphery of the holding space, for example to provide a greater and / or more uniform holding force.
[0039] According to one embodiment, the gas transport structure of the holding device may include at least one of the following: a) At least one main channel that can be connected to at least a portion of at least one opening. The main channel can have a larger cross-sectional area, for example, at an angle of 80 to 100 degrees with the main flow direction, compared to the cross-section of the secondary channels that lead to it. Thus, the main channel can bundle the flows of several secondary channels. b) a first main channel that may be fluidly connected to at least a portion of the openings of at least one opening of the first group, and a second main channel that may be different from the first main channel and that may be fluidly connected to the openings of the second group. The use of two main channels can simplify the gas transport structure, for example, by avoiding complex internal channels. Alternatively, more than two main channels or more than three main channels may be used. c) At least one gas flow (leakage) recess adjacent to (e.g., near) the at least one opening, e.g., a recess recessed laterally (or radially) outward and / or an axially recessed recess. The at least one gas flow (e.g., gas leakage) recess may be arranged so that gas flow between the at least one gas flow recess and the at least one opening is essentially restricted (blocked) by the object when a first side of the object faces the at least one opening, resulting in a relatively high suction force of the object against the holding device, and is effective (essentially unblocked) when a second side of the object faces the at least one abutment area and / or the at least one opening, resulting in a low suction force for holding the object. Thus, when the second side of the object faces the at least one opening, the object may form a wall, e.g., a wall portion, of a gas channel formed by the at least one gas flow recess and the at least one opening. At least two functions may be combined by providing at least one gas flow (leakage) recess, e.g., providing an air flow channel, and providing lateral alignment.
[0040] According to one embodiment, the at least one gas flow recess may be configured such that, when the second side faces the at least one opening, at least two gas channels are formed between the at least one gas flow recess and at least two of the at least one opening. The at least two gas channels between the at least one gas flow recess and the at least two openings may be blocked or at least essentially blocked by an object when the first side faces the at least one opening. Providing gas flow (leakage) recesses for some of the openings may simplify the holding device. However, a 1:1 arrangement of gas flow recesses and openings of the at least one opening may also be used.
[0041] According to a further embodiment, the at least one gas flow (leakage) recess may be a cylindrical or approximately cylindrical recess, for example open only on one lateral side of the cylinder, in particular adjacent to the holding space. Cylindrical recesses can be easily produced using a drill tool. However, other shapes may also be used.
[0042] According to one embodiment, the holding device may include at least one main channel that may be fluidly connected to at least one of the openings and that may redirect the gas flow in, for example, the suction channel starting at the at least one opening from a first flow direction to a second flow direction, wherein the angle between the first direction and the second direction may be in the range of 80 degrees to 100 degrees, preferably about 90 degrees or 90 degrees.
[0043] Preferably, the primary channels may include at least one, some (optional) or all of the following: a) an inlet portion including at least one inlet opening fluidly connected to a suction channel coming from at least one opening; b) A pipe offset structure or hose offset structure arranged downstream of the inlet portion of the main channel, preferably at the end of a pipe / hose arranged within the main channel, configured to define an offset between the sidewall of the main channel and the pipe / hose fluidly connected to the main channel. c) An outlet section comprising at least one or only one outlet opening, preferably a cylindrical or approximately cylindrical outlet section.
[0044] The inlet portion may have a cylindrical lower wall. The cylindrical wall, e.g., about half of a cylinder, may be laterally bounded on one side by a flat circular or semicircular shaped flat surface. The inlet portion may be open on the side opposite the flat surface. The open side may lead to another part of the gas transport structure, e.g., a space configured to hold one end of a tube or hose.
[0045] Thus, the inlet openings in the cylindrical lower wall may have different lateral offsets relative to the flat surface due to the circular arrangement of at least one opening for holding an object and due to the use of linear channels from these openings to the inlet portion, for example linear suction channels arranged parallel or essentially parallel to the flat surface.
[0046] Alternatively, the inlet section may be curved, following the curvature of the arc-shaped arrangement of at least one opening for holding an object. Again, there may be a lower cylindrical wall that includes a portion of the cylindrical surface. The cylindrical wall may be bounded by a curved circular or semicircular surface. The same distance of the inlet opening to the curved surface may be used. As above, the inlet section may be open on the side opposite the curved surface. A linear suction channel may be present between each of the at least one opening and each of the inlet openings. The linear suction channel may be aligned along a curve that follows the curve along which the at least one opening is arranged, for example, an arc-shaped curve.
[0047] The pipe or hose offset structure may provide a holding and / or sealing function for the pipe / pipe or flexible hose. The use of a flexible hose may make it easier to move the holding device, for example, by manual operation. The pipe or hose offset structure may be arc-shaped, for example, arc-shaped, or may have a semi-circular disk shape or any other suitable shape.
[0048] The offset structure may preferably extend only around a portion of the circumference of the circular side surface, for example, between more than one-quarter and less than three-quarters of the circumference. The remaining portion of the circumference may be used as an air channel forming a connection between the channel to the at least one opening and the rest of the gas transport structure. Thus, the offset structure may form a stop surface for a pipe or hose placed thereon.
[0049] However, alternatively, an external flange may be used to connect the tube / pipe / hose to the main channel by pulling or pushing the pipe or tube onto the flange, which may result in a better fit, e.g., less air leakage, etc., compared to an internal placement of the tube or pipe.
[0050] The outlet portion of the main channel may be configured to form an interior surface that can interact with the exterior surface of the tube / pipe or hose to form an airtight connection without further sealing means or without the use of further sealing means, such as gaskets, seal rings, etc.
[0051] The main channel may be hydrodynamically optimized to produce a uniform flow profile at the opening within the retention space.
[0052] According to further embodiments, the holding device may be manufactured by 3D (three-dimensional) printing. Additive manufacturing (additive manufacturing) may be used, as opposed to molding, for example, using expensive molds and expensive injection molding machines. Therefore, cost-effective production may be used even when only a small number of holding devices, for example, less than 1000, but for example, more than 10 or even more than 100, are produced. Filament printing or lithographic printing may be used. Optionally, a support material, for example, soluble in water or other chemical solutions, may be used selectively to the main material of the holding device. Furthermore, CAD (computer-aided design) data of the 3D printed model may be protected.
[0053] Alternatively, injection molding may be used to produce a holding device based on plastic material, however metal may also be used as the material for the holding device, for example using subtractive production machines (subtractive manufacturing).
[0054] According to a further aspect, the retention system may include: The holding device of any one of the preceding embodiments, wherein the holding device may include at least one opening disposed in a region that is covered by the object in a correct object orientation and that is not or is less covered by the object in a wrong object orientation. a negative pressure source, e.g., a pump; and a connection system for connecting or configured to connect a holding device and a negative pressure source. The gas transport structure described above may be part of the connection system. The connection system may be part of a pneumatic system. The pneumatic system may include, for example, a control unit and / or at least one valve. The control unit may control the negative pressure source and / or the valve to stop or interrupt the delivery of negative pressure, for example to release the object from the holding device.
[0055] Therefore, the technical effects described above with respect to the holding device may also apply to the holding system.
[0056] According to one aspect, the above object is solved by an apparatus comprising: a holding device according to any one of the above-mentioned embodiments or a holding system according to the above-mentioned embodiments, - an object configured to be held by a holding system for placing the object in a device during assembly of the device; and may include:
[0057] Therefore, the technical effects described above with respect to the holding device may also apply to the apparatus.
[0058] According to one aspect, there is provided a method of assembling a drug delivery device or an electronic module for a drug delivery device, the method may include at least one, any selection of, or all of the following: - providing or using a holding device according to any one of the above-mentioned embodiments, or providing a holding system according to the above-mentioned embodiments. - placing an object in the holding device. The object can be held in the holding device when the first side faces the at least one opening (e.g., correct orientation). The object, or another object of the same type, for example, especially having the same outer shape, can fall out of the holding device when the second side faces the at least one opening (e.g., incorrect orientation). This can be seen as an implicit confirmation of whether the object has been placed in the holding device in the correct or incorrect orientation. - Using the holding device to place an object in or on an object receiving space, e.g. in a drug delivery device or e.g. in an electronic module, where there may be relative movement between the holding device and the device or module to which it is assembled.
[0059] Thus, it can be ensured that an object is placed in the correct orientation and with the correct electrical contacts, e.g., relative to the positive and negative contacts of an electrical circuit, during assembly of a device or module. Proper operation of the electrical circuit can be ensured. Importantly, particularly in the medical field, for example, a patient's life may depend on the correct orientation and / or correct polarity of an object, e.g., a coin cell, being assembled into a device.
[0060] If an object is placed in the holding device in the wrong orientation, gravity and the low holding force will cause the object to fall out of the holding device, making it impossible to transport the object to a desired location with the wrong orientation.
[0061] Releasing the object can be achieved by interrupting the negative pressure, e.g., by turning off the pump, or by cutting off the air flow in an appropriate manner, e.g., using a valve. The pump of the pneumatic subsystem can be turned off, e.g., to release the electric battery (e.g., a coin cell) from the holding device. Alternatively and / or additionally, a tool can be used to release, e.g., the electric battery from the holding device, e.g., by inserting the tool into the gas leakage recess mentioned above or by pushing the tool from above through a hole extending through the holding device to the holding space.
[0062] Thus, the technical effects described above with respect to the holding device may also apply to the method, and vice versa.
[0063] According to one aspect, there is provided a drug delivery device, in particular a drug delivery device manufactured or manufacturable (producible) using the method described above. The drug delivery device may be, for example, an axially extending pen-type device. The drug delivery device may include at least one, or a discretionary selected number or all of the following: Preferably a housing, for example a housing containing a drive mechanism. - a container receptacle, for example, provided on or within the housing. The container receptacle may be configured to receive a container containing a drug (e.g., see the drug list below). Preferably, the container containing the drug may also be included within the drug delivery device, for example, the container may be disposed within the container receptacle. The container may be a cartridge including a coupling structure that is or can be coupled to a needle, for example, a needle having two sharp ends. An electronic module is preferably disposed within or on the housing. The electronic module may be configured to detect drug delivery, particularly the amount of drug delivered or a selected dose. The electronic module may be electrically powered by a power source contained within or formed by the object. A first surface of the object may be disposed more proximally than a second surface of the object. The first surface may be a flat surface that may have a first maximum lateral extent or diameter. The second surface may be a flat surface that may have a second maximum lateral extent or diameter. Preferably, the first maximum lateral extent or diameter may be at least 1 percent or at least 2 percent greater than the second maximum lateral extent or diameter. Preferably, the first surface may have an opposite electrical polarity compared to the second surface. The first maximum lateral extent or diameter may be no greater than 10 percent or 5 percent of the second maximum lateral extent or diameter.
[0064] Therefore, the technical effects described above with respect to the holding device may also apply to a drug delivery device assembled using the holding device.
[0065] The manufacture of drug delivery devices may allow for the use of standardized coin cells, for example, where the positive electrode may have a larger surface compared to the surface of the negative electrode. A chamfer or radius may be present on the side of the coin cell where the negative electrode is located.
[0066] Distal may refer to the end of the drug delivery device that is closest to the patient during use of the drug delivery device, e.g., the needle end. Proximal may refer to the opposite end, e.g., the end that is further from the needle.
[0067] The drug delivery device A plunger configured to interact with a stopper in a syringe or in another drug container, for example in a cartridge. - A manually actuated drive sleeve that extends proximally, for example during dose setting. - Holding space for containers containing medication. Optionally, the container itself. - A dose setting mechanism, including for example a number sleeve. - Caps, etc. may include at least one, a arbitrarily selected number, or all of:
[0068] The drug may be a drug as described below in the list of drugs, for example insulin.
[0069] The electronic module may be configured to detect drug delivery and / or detect or measure the amount of drug delivered and / or set. The electronic module may include a memory configured to store data regarding the drug, drug delivery time, and / or drug delivery amount. Furthermore, the electronic module may be configured to establish a data communication link with another device, for example, a smartphone or computing device. Thus, the electronic module may be configured to transmit data, for example, digital data, and / or receive data. Furthermore, the electronic module may include any of the components mentioned below.
[0070] According to a further aspect, there is provided an electronic module for a drug delivery device, in particular an electronic module manufactured using the holding device according to any one of the preceding embodiments. The electronic module may be configured to be mechanically connected to a drug delivery device configured to deliver a drug, in particular to a proximal end of the drug delivery device. The electronic module may be configured to detect drug delivery, in particular the amount of drug delivered or a selected (set) dose. The electronic module may be powered by or by an object, for example, a coin cell. The positive electrode of the object may be positioned more proximally compared to the negative electrode of the object, for example, a coin cell. The meaning of "proximal" may be the same as described above and may be used for an electronic module coupled to a drug delivery device.
[0071] Furthermore, the electronic module may be configured to establish a data communication link with another device, for example a smartphone or a computing device. Bluetooth (Special Interest Group, SIG), Bluetooth low energy, or other suitable data communication protocols, such as ZigBee (ZigBee-Alliance), may be used. The electronic module may include: - a microprocessor or microcontroller (which includes more peripheral circuits compared to a microprocessor that can be configured to execute operational code stored in a memory. Alternatively, another control unit, such as a finite state machine (ASIC (Application Specific Circuit)) may be used. - At least one motion detection sensor (e.g. rotational or translational). - at least one switch for switching to a second of the two operating modes, for example to a high-power mode that may consume significantly more power compared to the low-power mode, which may be selected, for example, by a further switch or by the passage of a predetermined time without user action;
[0072] According to a first embodiment, the sensor may include, for example, at least one light pipe or two light pipes, each of which transmits radiation to a rotating element having, for example, a tooth and a recess between adjacent teeth, and each light pipe receives light reflected from the rotating element. This may be axial detection. This embodiment may allow combining an electronic module with a drug delivery device that can also be used without an electronic module. The angular offset may be less than 30 degrees, for example, when two light pipes are used.
[0073] According to a second embodiment, the sensor may comprise, for example, at least one or at least two pairs of radiation source and radiation detector, for example an LED (light emitting diode) and a photodiode or a phototransistor, arranged, for example, at an angle of about 135 degrees, for example, or at other suitable values, for example, in the range of 10 degrees to 140 degrees, around the circumference of the encoder ring or other rotating part. The sensor may, for example, be arranged on a flexible PCB, to allow bending the sensor to its final sensing position and / or to avoid a separate electronic connection between the sensor and a main control unit of the electronic module, for example a processor or the like.
[0074] According to a further aspect, there is provided a method for holding an object, particularly during assembly of a drug delivery device or an electronic module for a drug delivery device, comprising at least one, arbitrarily selected ones or all of the following: - Laterally aligning an object. The object may include a first side and a second side opposite the first side of the object. The first side may have a different surface configuration compared to the second side. - Applying negative pressure through at least one opening to the aligned object, e.g. aligned using the alignment structure. - Realizing exclusive holding of the object depending on the side surfaces of the object adjacent to the at least one opening and depending on blocking of the at least one opening by each one of the side surfaces of the object, for example by blocking by an edge region of the object, preferably on a lateral surface opposite the first side surface of the object.
[0075] Thus, the technical effects described above with respect to the holding device may also apply to the method, and vice versa.
[0076] According to further embodiments, the method may comprise holding the object preferably in its lateral regions rather than in the central region. Details have been given above, see the description of the arrangement of the at least one opening. Due to different surface configurations on both relevant sides of the object, holding the object laterally may provide better possibilities for dedicated holding depending on the object's orientation. The method may be combined with any of the above-mentioned embodiments.
[0077] This application claims priority from European Patent Application Publication No. 22315293.5, filed with the European Patent Office in November 2022, the disclosure of which is expressly incorporated by reference into this disclosure for all legal purposes.
[0078] In the following, a series of aspects are disclosed. The aspects are numbered to facilitate reference to features of one aspect in other aspects. The aspects form part of the disclosure of this application and may be the subject of independent and / or dependent claims regardless of what is currently claimed in this application and independently of any references in parentheses.
[0079] 1. A holding device (10) for holding an object (O) during assembly of a medical device, comprising: Holding structure (HS) and Alignment structure (AS), Including, The holding structure (HS) includes at least one opening (21-1 to 21-4; 22-1 to 22-4), the alignment structure (AS) is configured to align the object (O) with respect to the holding structure (HS); The object (O) includes a first side (62) and a second side (66) of the object (O) opposite the first side (62); the first side (62) has a first surface configuration that is different from a second surface configuration of the second side (66); At least one opening (21-1 to 21-4; 22-1 to 22-4) is arranged to apply a negative pressure to a first side of the object (O); The holding device (10) is configured to hold the object (O) using negative pressure only in a first orientation in which a first side (62) of the object (O) faces the at least one opening (21-1 to 21-4; 22-1 to 22-4), but not in a second orientation in which a second side (66) of the object (O) faces the at least one opening (21-1 to 21-4; 22-1 to 22-4). A holding device (10).
[0080] 2. The alignment structure (AS) comprises at least one alignment area arranged to laterally align the object (O); At least one alignment region is preferably provided adjacent to at least one opening (21-1 to 21-4; 22-1 to 22-4) for holding the object (O) at at least one edge region of the object (O); 2. The holding device (10) according to embodiment 1.
[0081] 3. The holding structure (HS) comprises at least one abutment area (19) configured to abut the second side of the object, or alternatively the first side (62) and the second side (66), The holding device (10) according to aspect 1 or 2, wherein at least one opening (21-1 to 21-4; 22-1 to 22-4) is arranged at a different position compared to at least one abutment region (19), or at least one opening (21-1 to 21-4; 22-1 to 22-4) is arranged in at least one abutment region (19).
[0082] 4. Different surface configurations have the following characteristics, namely: a) the maximum lateral extent or diameter of the most prominent first surface (64) of the first side (62) is greater than the maximum lateral extent or diameter of the most prominent second surface (68) of the second side (66); Preferably, the first surface (64) has a larger surface area compared to the second surface (68); b) the surface roughness of the first surface (64) of the first side (62) is smaller than the surface roughness of the second surface (68) of the second side (66); c) a chamfered or rounded peripheral area on the first side (62) and an absence of such a peripheral area on the second side (66); d) other physical properties suitable for interacting with the gas flow through at least one opening (21-1 to 21-4; 22-1 to 22-4) to achieve dedicated retention of the object (O) depending on the orientation of the object (O) relative to said retention device (10); 10. The holding device (10) of any one of the preceding aspects, wherein the holding device (10) can be at least one of:
[0083] 5. The following characteristics: a) at least one abutment area (19) is arranged to provide an abutment surface for the object (O) in a first direction, preferably in the axial direction of the object (O), the alignment structure (AS) comprises at least one lateral support surface (20) or surface portion configured to align the object (O) in a second direction different from the first direction; b) the retention device (10) comprises a gas transport structure (GTS); The gas transport structure (GTS) includes at least one channel (23-1 to 23-4; 24-1 to 24-4; 25-1, 25-2) or tube (40-1, 40-2) connected to or connectable to at least one opening (21-1 to 21-4; 22-1 to 22-4) and configured to be connected to a negative pressure source; 10. The holding device (10) of any one of the preceding embodiments, comprising at least one of:
[0084] 6. Including the housing (H), The holding structure (HS) and / or alignment structure (AS) are provided on or within the housing (H), The housing (H) contains at least a portion of the gas transport structure (GTS), 10. The holding device (10) of any one of the preceding embodiments.
[0085] 7. A holding device (10) according to any one of the preceding aspects, comprising a cylindrical holding space (18) adapted to hold an object (O) and bounded by a holding structure (HS) and an alignment structure (AS).
[0086] 8. At least one first opening (21-1 to 21-4) of the at least one opening (21-1 to 21-4; 22-1 to 22-4) is arranged at a first location, and at least one second opening (22-1 to 22-4) of the at least one opening (21-1 to 21-4; 22-1 to 22-4) is arranged at a second location; the first location and the second location are located on opposite lateral surfaces of the holding structure (HS); Preferably, the at least one first opening (21-1 to 21-4) is part of a first group (G1) of at least one opening (21-1 to 21-4; 22-1 to 22-4), and / or the at least one second opening (22-1 to 22-4) is part of a second group (G2) of at least one opening (21-1 to 21-4; 22-1 to 22-4).
[0087] 9. Gas Transport Structures (GTS) are: a) at least one main channel (25-1, 25-2) connected to at least a portion of at least one opening (21-1 to 21-4; 22-1 to 22-4); b) a first primary channel (25-1) fluidly connected to at least a portion of at least one opening (21-1 to 21-4) of a first group (G1), and a second primary channel (25-2) different from the first primary channel (25-1) fluidly connected to at least a portion of at least one opening (22-1 to 22-4) of a second group (G2); c) at least one gas flow recess (29-1 to 29-3; 29-4 to 29-6) adjacent to at least one opening (21-1 to 21-4; 22-1 to 22-4), wherein the at least one gas flow recess (29-1 to 29-3; 29-4 to 29-6) is configured to allow gas flow between the at least one gas flow recess (29-1 to 29-3; 29-4 to 29-6) and the at least one opening (21-1 to 21-4; 22-1 to 22-4) to flow through the object (O at least one gas flow recess (29-1 to 29-3; 29-4 to 29-6) arranged so as to be essentially restricted by the object (O) when a first side of the recess (29-1 to 29-3; 29-4 to 29-6) faces the at least one opening (21-1 to 21-4; 22-1 to 22-4) and to be active when a second side of the recess (29-1 to 29-3; 29-4 to 29-6) faces at least one of the at least one opening (21-1 to 21-4; 22-1 to 22-4) and the at least one retention area (19); The holding device (10) according to any one of the preceding embodiments, in particular according to embodiment 5, comprising at least one of:
[0088] 10. the at least one gas flow recess (29-1 to 29-3; 29-4 to 29-6) is configured such that, when the second side (66) faces the at least one opening (21-1 to 21-4; 22-1 to 22-4), at least two gas channels are formed between the at least one gas flow recess (29-1 to 29-3; 29-4 to 29-6) and at least two of the at least one opening (21-1 to 21-4; 22-1 to 22-4); at least two gas channels between at least one gas flow recess (29-1 to 29-3; 29-4 to 29-6) and at least two openings (21-1 to 21-4; 22-1 to 22-4) are blocked or at least essentially blocked by an object (O) when the first side (62) faces the at least one opening (21-1 to 21-4; 22-1 to 22-4); 10. The holding device (10) of embodiment 9.
[0089] 11. at least one primary channel (25-1, 25-2) fluidly connected to at least one of the openings (21-1 to 21-4; 22-1 to 22-4) and redirecting the gas flow in at least one opening (21-1 to 21-4; 22-1 to 22-4) from a first flow direction to a second direction, wherein the angle between the first direction and the second direction is in the range of 80 degrees to 100 degrees, preferably about 90 degrees or 90 degrees; Preferably, the main channels (25-1, 25-2) are: a) an inlet portion including at least one inlet opening fluidically connected to a suction channel coming from at least one opening (21-1 to 21-4; 22-1 to 22-4); b) a pipe or hose offset structure (27) disposed downstream of the inlet portion of the main channel and configured to define an offset between a sidewall of the main channel and a pipe fluidly connected to the main channel; c) an outlet section comprising an outlet opening, preferably an essentially cylindrical outlet section or a cylindrical outlet section including at least one of 10. The retention device (10) of any one of the preceding embodiments, comprising a main channel (25-1, 25-2).
[0090] 12. A holding device (10) according to any one of the preceding embodiments; A negative pressure source; a connection system that connects or is configured to connect the holding device (10) to a negative pressure source; A retention system including:
[0091] 13. An apparatus (1) comprising: a holding device (10) according to any one of aspects 1 to 11 or a holding system according to aspect 12; and an object (O), the object (O) being configured to be held by the holding system for placing the object (O) within a device during assembly of the device.
[0092] 14. A method of assembling a drug delivery device (100) or an electronic module (EM) for a drug delivery device (100), comprising: Providing a holding device (100) according to any one of aspects 1 to 12 or an apparatus (1) according to aspect 13; Placing (240) an object (O) in a holding device (10), When the first side (62) faces the at least one opening (21-1 to 21-4; 22-1 to 22-4), the object (O) is held in the holding device (10); the object (O) or another object (O) falls from the holding device (10) when the second side (66) faces at least one opening (21-1 to 21-4; 22-1 to 22-4); Placement (240) and placing (270) an object (O) in or on an object receiving space in the drug delivery device (100) or in the electronic module (EM) using the holding device (10); A method comprising:
[0093] 15. A drug delivery device (100) manufactured or producible using the method of embodiment 14, comprising: a container receptacle configured to receive a container (106) containing a medication (Dr, M); a container receptacle, the container containing the drug (Dr, M) and the container (106) being placed in the container receptacle; an electronic module (EM); Including, The electronic module (EM) is electrically powered by a power source contained within or formed by the object (O), a first surface (64) of the object (O) disposed more proximally than a second surface (68) of the object (O); the first surface (64) is a flat surface having a first maximum lateral extent or diameter; the second surface (68) is a flat surface having a second maximum lateral extent or diameter; the first maximum lateral extent or diameter is greater than the second maximum lateral extent or diameter; The first surface (64) has an opposite electrical polarity compared to the second surface (68). A drug delivery device (100).
[0094] The making and use of this preferred embodiment is discussed in detail below. It should be understood, however, that this disclosure provides many applicable concepts that can be embodied in a wide variety of specific contexts. The specific embodiments discussed are merely illustrative of specific ways to make and use the disclosed concepts, and do not limit the scope of the claims.
[0095] Furthermore, the same reference numbers refer to the same technical features unless otherwise stated. When the word "may" is used in this application, it refers not only to the actual technical implementation but also to the possibility of doing so. This concept of the present disclosure will be described in a more specific context, namely, in a drug delivery device, particularly a drug delivery device for humans or animals, with reference to the preferred embodiments below. However, the disclosed concept may also be applied to other situations and / or configurations, such as other injectors, nebulizer devices, or inhalation devices. Alternatively, devices from other technical fields, such as remote controls, may be assembled using the proposed holding device and method.
[0096] The foregoing has outlined rather broadly the features and technical advantages of embodiments of the present disclosure. Additional features and advantages of embodiments of the present disclosure will be described below, e.g., in the subject matter of the dependent claims. Those skilled in the art will appreciate that the disclosed concepts and specific embodiments may be readily utilized as a basis for modifying or designing other structures or processes for achieving concepts having the same or similar purposes as those specifically discussed herein. Those skilled in the art will also recognize that equivalent constructions do not depart from the spirit and scope of the present disclosure, as defined in the appended claims.
[0097] For a more complete understanding of the concepts disclosed herein and their advantages, reference is now made to the following description taken in conjunction with the accompanying drawings, which are not drawn to scale, in which: [Brief explanation of the drawings]
[0098] [Figure 1] FIG. 1 is a plan view of a drug delivery device including a dose knob as an example of an application device for an object whose orientation should be correctly defined. [Figure 2] A cross-sectional view of one embodiment of an electronic module / dosage knob as an example of an application device for a coin cell battery, which contains a coin cell battery in the correct orientation and is an example of an object whose orientation should be correctly defined. [Figure 3] FIG. 3 is a cross-sectional view of the electronics module / dosage knob of FIG. 2 containing a coin cell battery in the wrong orientation. [Figure 4] FIG. 1 is a perspective view of an exemplary embodiment of an assembly, the assembly including an embodiment of an object orientation-sensitive holding device and a coin cell battery as an exemplary embodiment of an object whose orientation should be correctly defined, the coin cell being held in the correct orientation within a receiving area of the device. [Figure 5] 1A and 1B are perspective views of an exemplary embodiment of an object orientation sensitive holding device. [Figure 6]A cross-sectional view of an exemplary embodiment of an assembly including an object orientation sensitive holding device and a coin cell as an exemplary embodiment of an object, the coin cell being held and housed in the correct orientation within a housing area of the device. [Figure 7] 7 is a cross-sectional view of an assembly including the object orientation sensitive holding device of FIG. 6 and a coin cell, the coin cell being received in the receiving area of the device in the wrong orientation. [Figure 8] FIG. 1 is a flow diagram of a method for providing an object in its correct orientation for use in an object application device. DETAILED DESCRIPTION OF THE INVENTION
[0099] Identical elements, elements of the same type, and elements that act identically or similarly may be provided with the same reference numbers within the drawings.
[0100] A cylindrical coordinate system may be referenced, i.e., each position may be defined by three coordinates: an axial value (height, distance to the zero plane), a radial distance to the axis, and an angle between the current radial position and a plane defined as having an angle of zero. As used herein, the term "at an axial position" may mean having an axial coordinate.
[0101] The distal end D may be the end closer to the needle than the proximal end P.
[0102] FIG. 1 shows a plan view of a drug delivery device 100 including a dose knob 116 as an example of an application device 90 of an object O whose orientation should be correctly defined.
[0103] The drug delivery device 100 may be manufactured or may be manufacturable using the methods described below (see description of FIG. 8 and corresponding description). a housing 102; a container receptacle, which may be configured to receive a container 106 containing a drug Dr, M (see e.g. the list of drugs below), a container receptacle, preferably containing a drug Dr, M, in which the container 106 can be placed; - an electronic module EM, preferably arranged in or on the housing 102, which electronic module EM can be electrically powered by a power source contained in or formed by the object O (see Figures 2 to 7).
[0104] A first surface 64 (see, e.g., FIG. 2 ) of the object O may be disposed more proximally P than a second surface 68 (see, e.g., FIG. 2 ) of the object O. The first surface 64 may be a flat surface having a first maximum lateral extent or diameter. The second surface 68 may be a flat surface having a second maximum lateral extent or diameter. The first maximum lateral extent or diameter may be greater than the second maximum lateral extent or diameter, preferably at least 1 percent or at least 2 percent of the second maximum lateral extent or diameter. The first surface 64 may have an opposite electrical polarity, e.g., a positive potential, compared to the second surface 68, which may have, e.g., a negative potential.
[0105] The window 104 may be used to display the amount of drug Dr, M selected by a user or patient using the drug delivery device 100. The drug delivery device 100 may be an axially extending pen-type device. The drive sleeve may extend proximally from the housing 102 during dose selection or dose setting and may be pushed into the housing 102 during drug delivery performed manually by the user. However, the drug delivery device 100 may also be another type of drug delivery device, such as an autoinjector, or a device that includes a torsion spring to provide force to support drug delivery or to provide the overall force for drug delivery.
[0106] The needle 108 may be attached to the container 106 or to a receptacle in the container 106. The container 106 may be a cartridge, and the receptacle may be a cartridge holder. The needle 108 may have two sharp ends. One end of the needle 108 may be configured to pierce a sealing member of the cartridge. The other end of the needle 108 may be configured to pierce the skin of a patient.
[0107] The needle 108 may be protected by an inner needle cap 110 and either an outer needle cap 112 or a cap 114 of the drug delivery device 100 .
[0108] The dose of drug Dr or medication M, e.g., insulin, to be expelled from the drug delivery device 100 may be set, for example, by turning the dose knob 116, after which the currently programmed or set dose may be displayed, for example in multiples of units, via the dose window 104. This may be achieved by a suitable internal dose setting mechanism of the drug delivery device 100. The indicia displayed in the dose window 104 may be provided on a dial or number sleeve 120.
[0109] The dose knob 116 may also have an injection button 118, for example on its proximal end. Alternatively, the dose knob 116 may be configured to function as the injection button 118. When the needle 108 is inserted into a portion of the patient's skin and the dose knob 116 or injection button 118 is then pressed axially, for example distally, a dose of drug (e.g., insulin) contained within the container 106, the amount of which may be displayed in the dose window 104, is expelled from the drug delivery device 100.
[0110] The electronic module EM may be arranged in the drug delivery device 100, for example as an integral component, for example in the dose knob 116. Alternatively, the electronic module EM may be an additional part that may be coupled to the proximal end of the drug delivery device 100, for example clipped, screwed, etc. to the dose knob 116. A second alternative may allow the use of the electronic module EM in several drug delivery devices 100 of the same type, thereby providing for multiple use of a relatively expensive electronic module EM. Furthermore, only one power source (battery) or one power source set may be used by a user or patient over a long period of time, thereby reducing the environmental impact of the production and / or waste disposal of the electronic module EM.
[0111] An electrical energy source, for example an electric battery, may be provided for powering the electrical module EM. The electric battery may be rechargeable or non-rechargeable. An example of a non-rechargeable battery is a battery in the form of a coin cell battery 98 (see, for example, Figures 2 and 3). An example of a coin cell is a CR1225 type coin cell. However, other types of coin cells may also be used. According to the international standard IEC (International Electrotechnical Commission) 60086-3, "C" stands for lithium and "R" stands for round.
[0112] FIG. 2 shows a cross-sectional view of one embodiment of an electronic module EM or dosage knob 116 as an example of an application device 90 for a coin cell battery 98 as an example of an object O whose orientation should be correctly defined, containing a coin cell battery 98 in the correct orientation.
[0113] The object O may be, for example, a coin cell 98. The coin cell 98 may include a first side 62 and a second side 66. The first side 62 may include a first surface 64, for example, an essentially flat surface. The second side 66 may include a second surface 68, for example, an essentially flat surface. The first surface 64 may have a larger diameter and / or a larger surface area compared to the diameter and / or surface area of the second surface 68.
[0114] The first surface 64 may be part of the positive electrode PE of the coin cell 98. The positive electrode PE may also extend circumferentially around the coin cell or at the boundary of the second side surface 66. The second surface 68 may be part of the negative electrode ME of the coin cell 98. An insulating region, such as a seal ring, may be disposed between the positive electrode PE and the negative electrode ME of the second side surface 66, which may also perform a sealing function to seal the internal components of the coin cell 98 from the outside of the coin cell 98, such as environmental gas 30, humidity, dust, etc.
[0115] The external or internal electronic module EM may include a base part 91 (e.g., a chassis), which may be essentially cylindrical and which contains the main components of the electronic module EM, e.g. - circuit board 92, - Coin Cell 98, - electromechanical contact elements that electrically connect the coin cell 98 to the circuit board 92; - a sensor element (not shown), and / or - switching elements (not shown), etc. may be configured to hold
[0116] The circuit board 92 may be, for example, a "printed" circuit board (PCB) having at least one layer of conductors that appear printed on the circuit board, although photolithography techniques may typically be used to manufacture the circuit board 92.
[0117] The circuit board 92 may have and connect several electronic and / or electromechanical components to form a printed circuit board assembly (PCBA). Examples of components are, for example, a processor, conductors, resistors, and / or capacitors, etc. An example of a sensor element is a radiation sensor, such as a sensor for electromagnetic radiation, preferably in the visible spectrum or the UV (ultraviolet) or IR (infrared) spectral region.
[0118] The contact elements that contact the coin cell 98 or other components may include at least one resilient metal sheet element (see, for example, positive electrical contact clamp 94). The negative contact element may also include a resilient metal sheet element or another suitable conductive surface. The negative contact element is not shown in FIGS. 2 and 3.
[0119] An exemplary positive electrical contact clamp 94 includes: - a positive electrical contact bridge 95, and At least two positive electrical contact ends 96, connected to the bridge 95, for example on opposite sides of the bridge 95, and conductively connected to the circuit board 92; may include:
[0120] Other shapes of the positive contact clamp 94 are possible.
[0121] A cover portion 97 may form a housing for the electronic module EM and may also be disposed on the base portion 91 (e.g., chassis). A dose dial interface may be disposed on the periphery of the electronic module. An injection button interface may be formed on the proximal end face of the electronic module EM.
[0122] The axis of rotation 99 may be the axis about which the electronic module EM rotates during dose selection (dose setting) and along which the electronic module EM slides during dose injection.
[0123] The following examples relate to dedicated assembly in the correct orientation of the battery, e.g., a coin cell assembly holder with polarity exclusion / detection, however, the concepts may also be applicable to other objects O, especially objects O with different surface configurations in the edge regions, and / or flat objects.
[0124] The embodiments relate to the use of gas suction to hold a coin cell 98 or another object O in an assembly tool (see holding device 10 (FIGS. 4-7)) when it is correctly oriented, but not when it is incorrectly oriented. Illustratively, this concept may be applicable to assembly tools for electronic devices requiring coin cells 98, and may be intended to ensure that the coin cells are assembled with the correct polarity. This may be particularly useful on manual assembly lines where a human operator may be responsible for selecting the orientation of the coin cell 98 or another object O. The embodiments may be applicable to any component having an asymmetric geometry relative to the midplane of the object O, for example. A prototype assembly tool including these features has performed well in initial testing.
[0125] Thus, a manual assembly tool (see, e.g., holding device 10 or a similar device) can allow a coin cell 98 or other object O to be held only when it is correctly oriented, thereby preventing incorrect assembly.
[0126] The correct orientation of the coin cell 98 may be as shown in Figure 2, for example, with the positive electrode PE disposed proximal to the negative electrode ME. Thus, the positive electrical contact clamp 94 may contact the positive electrode PE on the first side 62 and / or first surface 64. The negative electrode ME may be oriented toward a negative contact element, not shown in Figures 2 and 3. The negative contact element may contact the second surface 68 of the second side 66 to provide the correct electrical connection.
[0127] FIG. 3 shows a cross-sectional view of the electronics module EM / dosage knob 116 of FIG. 2 with the coin cell battery O, 98 contained within the electronics module EM / dosage knob 116 in the wrong orientation.
[0128] Therefore, it may be possible to easily assemble the coin cell 98 to the add-on electronic module EM in two orientations. In each orientation, the coin cell is connected with a different polarity. If the coin cell is connected to the PCBA with the reverse polarity, voltage will be applied to the circuit in the wrong direction and the electronic module EM will not function. Having a power supply voltage outside the absolute maximum rating may also damage electrical components, requiring the PCBA to be discarded because, for example, the damage may be invisible, difficult to detect, and impossible to correct an assembly error.
[0129] An incorrect orientation of the coin cell 98 may be, for example, the orientation shown in Figure 3, in which the negative electrode ME is disposed proximal to the positive (positive) electrode PE. Thus, the positive electrical contact clamp 94 may contact the negative (negative) electrode ME on the second side 66 and / or second surface 68. The positive electrode PE may be oriented toward a negative contact piece / element not shown in Figures 2 and 3. The negative contact piece may contact the first surface 64 of the first side 62, thereby providing an incorrect electrical connection.
[0130] 4 shows a perspective view of an exemplary embodiment of assembly 1. Assembly 1 may include an embodiment of object orientation sensitive holding device 10 and a coin cell battery 98 as an exemplary embodiment of object O. The orientation of coin cell battery 98 is properly defined, and coin cell 98 is held in the correct orientation within a receiving area or holding space 18 (see FIG. 5 ) of holding device 10. The properly oriented coin cell 98 is transferred to the electronic module in the correct orientation, thereby ensuring that assembly of coin cell 98 to the electronic module is also performed in the correct orientation, as described in more detail below (see FIG. 8 and corresponding description).
[0131] The holding device 10 may be used to hold an object O, e.g., a coin cell 98, during assembly of a medical device, e.g., a drug delivery device 100, or an electronic module EM that may form part of a medical device, e.g., a drug delivery device 100. - a retaining structure HS (see FIG. 5), (see for example the abutment area 19 (abutment surface) in FIG. 5), - alignment structures AS (see e.g. lateral support surfaces 20); may include:
[0132] The retaining structure HS may include at least one opening 21-1 to 21-4; 22-1 to 22-4 (see FIG. 5).
[0133] The alignment structure AS may be configured to laterally align the object O, e.g., coin cell 98, with respect to the holding structure HS. As already mentioned above, the object O may include a first side, e.g., 62, and a second side, e.g., 66, opposite the first side, e.g., 62, of the object O. The first side, e.g., 62, may have a first surface configuration that differs from a second surface configuration of the second side, e.g., 66. At least one opening 21-1 to 21-4; 22-1 to 22-4 may be arranged to apply a negative pressure to the first side, e.g., 62, of the object O. The holding device 10 may be configured to hold the object O using negative pressure only in a first orientation in which a first side of the object O, e.g., 62, faces and / or abuts the at least one opening 21-1 to 21-4; 22-1 to 22-4, but not in a second orientation in which a second side, e.g., 66, faces the at least one opening 21-1 to 21-4; 22-1 to 22-4.
[0134] The housing H of the holding device 10 is a first major surface 12, for example an essentially flat annular surface; a second main surface 14, for example a circular flat surface, a cylindrical outer surface 16; a cylindrical holding space 18 (see FIG. 5); abutment area 19 (abutment surface) (see FIG. 5 ); - lateral support surfaces 20, e.g. cylindrical walls; may include:
[0135] The axis A may extend from the proximal end of the housing H to the distal end of the housing H. The housing H may have any suitable shape, and in particular the outer surface may be modified, for example, into a rectangular parallelepiped shape.
[0136] The cylindrical holding space 18 (see FIG. 5) may be sufficiently adapted to, e.g., have an essentially complementary shape to, the shape of the object O, e.g., the coin cell 98. The same may therefore be true with respect to the abutment surface 19 (at least on one side of the object O) and with respect to the lateral holding surfaces 20.
[0137] Gas flow recesses 29-1 to 29-3; 29-4 to 29-6 (or air leakage recesses if air is used as the gas) may be arranged adjacent to the openings 21-1 to 21-4; 22-1 to 22-4 (see, for example, FIG. 5).
[0138] The first gas hose 40-1, particularly the first end 42-1 of the gas hose 40-1, can be fluidly connected to the openings 21-1 to 21-4. The second gas hose 40-2, particularly the first end 42-2 of the gas hose 40-2, can be fluidly connected to the openings 22-1 to 22-4. The second end of the first gas hose 40-1 and the second end of the second gas hose 40-2 can be fluidly connected to a negative pressure source, such as a pump device. A Y-connector or other connector including at least three ports can be used to connect the second ends of the gas hoses 40-1 and 40-2 to a pressure source. Alternatively, two pressure sources or a pressure source including at least two ports can be used.
[0139] An electrical control unit may be connected to the pressure source to control the pressure and / or turn the negative pressure source on and off. Alternatively, a valve may be used to turn the negative pressure off or on. The valve may be electrically connected to the control unit and fluidly connected to the first gas hose 40-1 and / or the second gas hose 40-2. Alternatively, at least two valves may be used. Furthermore, the control unit may have or be connected to an input switch, for example, operated by an operator's foot, for turning off the negative pressure in the holding device to release the object O, e.g., coin cell 98, when it is transported to a final assembly location within the device, e.g., within the drug delivery device 100 or the electronic module EM.
[0140] 4, second side 66 is the underside and second surface 68 is the bottom surface, which is the correct orientation for object O, e.g., coin cell 98, as described above with reference to FIG.
[0141] In the described concept, a coin cell 98 or another object O may be held against gravity within an assembly tool (holding device 10), for example, using a negative pressure gas flow that creates suction. An external gas flow source capable of generating negative gas pressure may be connected to, for example, a suction array, e.g., openings 21-1 to 21-4, using hoses, e.g., 40-1, 40-2, etc. Gas hoses, e.g., 40-1, 40-2, etc., may be assembled to the upper tool (holding device 10) with an interference fit. Pipe offset surfaces 28 (see FIG. 5) may prevent the hose openings from being flush with the end face, which would impede flow. The coin cell 98 or another object O may be laterally aligned by a cylindrical holding surface. Gas leakage recesses 29-1 to 29-6 may ensure that gas flow to the suction array is not restricted by radial contact between the coin cell 98 or another object O and the upper tool (holding device 10).
[0142] 5 shows a perspective view of an exemplary embodiment of an object orientation-sensitive holding device. The alignment structure AS may include at least one alignment region (see, for example, cylindrical wall 20) provided for laterally aligning the object O. The at least one alignment region may preferably be provided (arranged) adjacent to at least one opening 21-1 to 21-4; 22-1 to 22-4 for holding the object O at at least one edge region of the object O.
[0143] Cylindrical wall 20 may be essentially closed along its periphery, e.g., not with respect to the area having gas flow regions 29-1 through 29-6. Alternatively, only a segment of a circular wall, e.g., two segments, may be used, e.g., in combination with gas flow regions 29-1 through 29-6. There may be no lateral alignment region between the segments, e.g., no wall, or there may be another wall (segment) of a different shape, e.g., a straight wall (segment).
[0144] The openings 21-1 to 21-4; 22-1 to 22-4 may be grouped into two groups G1, G2 separated from each other by an area that does not include openings. The openings in each group G1, G2 may be arranged in a one-dimensional array of openings. In this example, for example, seven openings may be arranged along an arc, such as a circular arc. Of course, fewer or more than seven openings may be present in a group G1, G2. The distance, particularly the circumferential distance, between adjacent openings 21-1 to 21-4; 22-1 to 22-4 in one group G1, G2 of openings 21-1 to 21-4; 22-1 to 22-4 may be constant; for example, adjacent openings 21-1 to 21-4; 22-1 to 22-4 in one group G1, G2 may be arranged equidistantly. However, different distances between adjacent openings 21-1 to 21-4; 22-1 to 22-4 may be used, for example, to generate the same suction force for each opening.
[0145] In this example, one group G1, G2 (array) of openings 21-1 to 21-4; 22-1 to 22-4 extends in the circumferential direction only along an angle less than 30 degrees or less than 20 degrees, for example, more than 10 degrees.
[0146] Furthermore, in this example, circular holes are used as the openings 21-1 to 21-4; 22-1 to 22-4. However, alternatively, openings having or including other shapes may also be used, such as relatively short or long slits, oval shapes, etc.
[0147] Furthermore, there may be other possibilities, for example, to arrange the openings in no groups along the entire perimeter or in more than two groups G1, G2 along the entire perimeter.
[0148] The retaining structure HS may include at least one abutment area 19 configured to abut the second side 66 of the object O, 98, or alternatively the first side 62 and the second side 66. The abutment area 19 may extend in a plane, for example a circular plane.
[0149] At least one opening 21-1 to 21-4; 22-1 to 22-4 may be arranged at a different position compared to at least one contact area 19. This may result in separation of the contact function and the suction function, particularly when the second side surface 66 is in contact with the contact area 19 and the object O is not held.
[0150] Alternatively, at least one opening 21-1 to 21-4; 22-1 to 22-4 may be arranged in at least one abutment region 19. Thus, the abutment function and the suction function may be tightly combined in the abutment region 19.
[0151] Also, there may be two different abutment areas depending on the side of the object O facing the abutment area. Thus, the central abutment area 19 may be used when the second side 66 of the object O, 98 faces the abutment area. The abutment areas around the openings 21-1 to 21-4; 22-1 to 22-4 may be used when the first side 62 of the object O, 98 faces the abutment area.
[0152] The different surface configurations may be due to at least one of the following characteristics: a) The maximum lateral extent or diameter of the most prominent first surface 64 of the first side 62 is greater than the maximum lateral extent or diameter of the most prominent second surface 68 of the second side 66. The first surface 64 may have a greater surface area than the second surface 68. b) The first surface 64 of the first side 62 has a smaller surface roughness compared to the surface roughness of the second surface 68 of the second side 66. Thus, a coin cell battery may have a second side 68, e.g., a negative electrode ME, that has a pattern. The pattern may result in a greater surface roughness compared to the first side 62 and its first surface 64, e.g., a positive electrode PE. Thus, the first surface 64 may have a smoother surface profile compared to the second surface 68. c) A chamfered peripheral region on the first side 62, but there may be no such chamfered peripheral region on the second side 66, preferably along the entire periphery. Thus, rotation of the object O, 98 about its longitudinal axis is not an issue, and for example, rotational alignment may not be required. This is typically the case for coin cell shaped batteries. d) Other physical properties suitable for interacting with a gas flow, e.g., an air flow, through at least one opening 21-1 to 21-4; 22-1 to 22-4 to achieve dedicated holding of the object O depending on its orientation relative to the holding device 10.
[0153] The retention device 10 may have two side openings 26-1, 26-2. The offset structure 27 may be disposed in a recess extending radially inward from the side openings 26-1, 26-2. An offset surface 28 may be formed on the offset structure 27, as will be described in more detail below.
[0154] FIG. 6 shows a cross-sectional view of an exemplary embodiment of an assembly 1 including an object orientation-sensitive holding device 10 and a coin cell O, 98 as an exemplary embodiment of an object O, where the coin cell 98 is held and housed in the correct orientation within a storage area (e.g., a cylindrical holding space 18) of the holding device 10.
[0155] The holding device 10 may include at least one of the following features. a) The at least one abutment area 19 may be arranged to provide an abutment surface for the object O in a first direction, preferably in the axial direction of the object O. The alignment structure AS may comprise at least one lateral retaining surface 20 or surface portion configured to align the object O in a second direction different from the first direction, for example laterally, for example to the left or right of Figure 6, or in the plane of Figure 6 or out of the plane of Figure 6, i.e. in or out of the plane of the paper sheet or the display on which Figure 6 is displayed. b) The holding device 10 may include a gas transport structure GTS, for example an air transport structure. However, other gases may also be used. The gas transport structure GTS may include at least one channel 23-1 to 23-4; 24-1 to 24-4; 25-1, 25-2 or tube 40-1, 40-2 connected to or connectable to at least one opening 21-1 to 21-4; 22-1 to 22-4 and configured to be connected to a negative pressure source, for example a pump, preferably a diaphragm pump or a membrane pump.
[0156] The holding device 10 may include a housing H. Alternatively, a hose system and holding plates may be used. The holding structure HS and / or the alignment structure AS may be provided on or in the housing H. Furthermore, the housing H may include gas transport structures GTS, e.g., at least parts of gas channels, adjacent the openings 21-1 to 21-4; 22-1 to 22-4, etc. The housing H may be made of plastic or another suitable material, e.g., metal.
[0157] The holding device 10 may be adapted to hold an object O and may include a cylindrical holding space 18 which may be bounded by holding structures HS and / or alignment structures AS.
[0158] At least one first opening 21-1 to 21-4 of the at least one opening 21-1 to 21-4; 22-1 to 22-4 may be located at a first location. At least one second opening 22-1 to 22-4 of the at least one opening 21-1 to 21-4; 22-1 to 22-4 may be located at a second location. The first and second locations may be located on opposite lateral surfaces of the retaining structure HS. At least one first opening 21-1 to 21-4 or all first openings 21-1 to 21-4 may be part of a first group G1 of at least one opening 21-1 to 21-4; 22-1 to 22-4. At least one or all of the second openings 22-1 to 22-4 may be part of a second group G2 of at least one of the openings 21-1 to 21-4; 22-1 to 22-4.
[0159] The gas transport structure GTS may include at least one of the following: a) at least one main channel 25-1, 25-2 that can be connected to at least a portion of at least one opening 21-1 to 21-4; 22-1 to 22-4; b) a first primary channel 25-1 that may be fluidly connected with at least a portion or all of at least one opening 21-1 to 21-4 of the first group G1, and a second primary channel 25-2 that may be different from the first primary channel 25-1 and that may be fluidly connected with at least a portion or all of at least one opening 22-1 to 22-4 of the second group G2; c) at least one gas flow recess 29-1 to 29-3; 29-4 to 29-6 adjacent, e.g., close to, at least one opening 21-1 to 21-4; 22-1 to 22-4. The at least one gas flow (e.g., gas leakage) recess 29-1 to 29-3; 29-4 to 29-6 may be arranged such that gas flow between the at least one gas flow recess 29-1 to 29-3; 29-4 to 29-6 and the at least one opening 21-1 to 21-4; 22-1 to 22-4 is restricted, e.g., essentially blocked, by the object O when a first side 62 of the object O faces the at least one opening 21-1 to 21-4; 22-1 to 22-4, and is active when a second side 66 of the object O faces the at least one opening 21-1 to 21-4; 22-1 to 22-4 and / or the at least one abutment area 19.
[0160] At least one gas flow recess 29-1 to 29-3; 29-4 to 29-6 may be configured such that at least two gas channels are formed between at least one gas flow recess 29-1 to 29-3; 29-4 to 29-6 and at least two of the at least one opening 21-1 to 21-4; 22-1 to 22-4 when the second side 66 of the object O faces the at least one opening 21-1 to 21-4; 22-1 to 22-4. The at least two gas channels between the at least one gas flow recess 29-1 to 29-3; 29-4 to 29-6 and the at least two openings 21-1 to 21-4; 22-1 to 22-4 may be blocked or at least essentially blocked by the object O when the first side 62 faces the at least one opening 21-1 to 21-4; 22-1 to 22-4.
[0161] It goes without saying that more or less than three gas flow recesses 29-1 to 29-3; 29-4 to 29-6 may be used on each lateral side of the holding device 10.
[0162] Gas flow recesses 29-1 to 29-3; 29-4 to 29-6 may have, for example, a cylindrical shape with an open side relative to cylindrical wall 20. Alternatively, gas flow recesses 29-1 to 29-3; 29-4 to 29-6 may have other shapes, for example, an elliptical base and an elliptical cross section parallel to the base. Rectangular shapes may also be used for gas flow recesses 29-1 to 29-3; 29-4 to 29-6.
[0163] The primary channels 25-1, 25-2 may be fluidly connected to at least one of the openings 21-1 to 21-4; 22-1 to 22-4, preferably to the openings 21-1 to 21-4 of group G1 and to the openings 22-1 to 22-4 of group G2, respectively. The primary channels 25-1, 25-2 may redirect the gas flow (first flow direction 36) coming from at least one of the openings 21-1 to 21-4; 22-1 to 22-4 into a second direction 38 of gas (e.g., air) flow. The angle between the first direction 36 and the second direction 38 may be in the range of 80 degrees to 100 degrees, preferably about 90 degrees or 90 degrees.
[0164] The primary channels 25-1, 25-2 may include at least one of the following: a) an inlet portion including at least one inlet opening fluidically connected to a suction channel coming from at least one opening 21-1 to 21-4; 22-1 to 22-4, the inlet portion extending along the lower half of the main channels 25-1, 25-2; b) A tube or hose offset structure 27 disposed downstream of the inlet portion of the primary channel 25-1, 25-2 and configured to define an offset between the sidewall of the primary channel 25-1, 25-2 and a tube or hose 40-1, 40-2 fluidly connected to the primary channel 25-1, 25-2. Preferably, one end 42-1, 42-2 of the tube / hose 40-1, 40-2 may be disposed within the primary channel 25-1, 25-2. The first end 42-1, 42-2 of the tube or hose 40-1, 40-2 may abut an offset surface 28 on the offset structure 27, thereby defining a distance between the tube or hose 40-1, 40-2 and the opposite sidewall of the primary channel 25-1, 25-2. This distance may prevent channels 23-1 through 23-4, etc., from being blocked by the hose 40-1, e.g., the first end 42-1 of the hose 40-1. A similar distance may prevent channels 24-1 to 24-4, etc. from being blocked by hose 40-2, for example, by first end 42-2 of hose 40-2. c) An outlet portion comprising an outlet opening, preferably an essentially circular outlet opening, which may comprise two semicircles of different radii, for example a smaller semicircle defined by the offset structure 27 and a larger semicircle defined by the inlet portion.
[0165] The following channels may be present: - suction channels 23-1 to 23-4 etc. between the inlet portion of the main channel 25-1 and each of the openings 21-1 to 21-4 etc., and - Suction channels 24-1 to 24-4 etc. between the inlet portion of the main channel 25-1 and each of the openings 22-1 to 22-4.
[0166] The negative pressure supply openings 26-1 and 26-2 may be fluidly connected to a negative pressure source (not shown) via hoses 40-1 and 40-2, respectively. Rigid pipes may be used instead of the flexible hoses 40-1 and 40-2. The negative pressure source may be, for example, a pump.
[0167] As shown in FIG. 6, the following relatively weak gas flow (eg, when compared to the corresponding flow shown in FIG. 7) may be established between the gas (eg, air) environment 30 and the negative pressure source. a gas flow 32 from the environment 30 through the gas flow recesses 29-2, 29-5, etc. and through small gaps between the first surface 64 and the openings 21-1 to 21-4, etc.; 22-1 to 22-4, etc. to reach the openings 21-1 to 21-4, etc., 22-1 to 22-4, etc. This means that an object O, for example a battery in the form of a coin cell 98, may essentially or completely block the resulting gas flow; for example, the flow may be less than 30 percent or less than 10 percent of the corresponding flow associated with FIG. 7 . A gas flow 36 from the openings 21-1 to 21-4 etc., 22-1 to 22-4 etc. through the suction channels 23-1 to 23-4 etc.; 24-1 to 24-4 etc. into the inlet portions of the main channels 25-1, 25-2, respectively. - A gas flow 38 entering the hoses 40-1, 40-2 from the outlet portions of the main channels 25-1, 25-2, respectively. Further gas flow (not shown) through hoses 40-1, 40-2, any connections and / or valves to a negative pressure source (also not shown).
[0168] The resulting attractive force 34 may be relatively high, for example, when compared to the attractive force 35 associated with the embodiments and apparatus shown in FIG. 7 and described in detail below. Thus, the object O (e.g., coin cell 98) may be held with a relatively high holding force in the orientation shown in FIG. 6 , where, for example, the first normal vector 74 of the first surface 64 (e.g., the positive electrode PE) is directed toward the holding device 10 and the second normal vector 84 of the second surface 68 (e.g., the negative electrode ME) is directed away from the holding device 10. Holding of the object O, e.g., coin cell 98, may be possible because the holding force is higher than the force of gravity acting on the object O, 98.
[0169] The retention system is a holding device 10 according to any one of the above-mentioned embodiments, - a negative pressure source, and a connection system for connecting or adapted to connect the holding device 10 to a negative pressure source; It may include at least one of:
[0170] The apparatus 1 may include a holding device 10 described in any one of the above-described embodiments or the above-described holding system, and an object O, 98 configured to be held in the holding system for placing the object O, 98 in a device, e.g., a drug delivery device 100 or an electronic module EM, during assembly of the device, e.g., a device 100 or an electronic module EM.
[0171] When an operator places a properly oriented coin cell 98 or other object O into the upper tool 10, the coin cell 98 or other object O covers a recess, such as an array of suction openings 21-1 through 22-4, which may be positioned toward the edge of the holding space 18, restricting gas flow. The resulting suction force 34 is greater than the gravitational attraction, so the coin cell 98 or other object O is held within the upper tool (holding device 10).
[0172] Figure 7 shows a cross-sectional view of an assembly 1 including the object orientation sensitive holding device 10 of Figure 6 and a coin cell 98, where the coin cell 98 or another object is contained in an incorrect orientation within a storage area, e.g., holding space 18, of the holding device 10.
[0173] If an operator places an incorrectly oriented coin cell 98 or other object O in an upper tool, e.g., holding device 10, the coin cell 98 or other object O will not cover the suction array, e.g., openings 21-1 to 22-4, for example, due to a reduced diameter area on its negative polarity side (e.g., negative electrode ME), and no suction, or only very weak suction, will be applied to the coin cell 98 or other object O, causing the coin cell 98 or other object O to fall out of the tool, e.g., holding device 10, under gravity.
[0174] As shown in FIG. 7, the following relatively strong gas flow (eg, when compared to the corresponding gas flow shown in FIG. 6) can be established between the gas (eg, air) environment 30 and the negative pressure source. a gas flow 32 from the environment 30 through the gas flow recesses 29-2, 29-5, etc., through channels formed between the holding device 10 and the boundary or object O, coin cell 98 (e.g., there may be a relatively large gap between the edge of the second side 66 of the object O and the openings 21-1 to 21-4, etc.; 22-1 to 22-4, etc.) to reach the openings 21-1 to 21-4, etc., 22-1 to 22-4, etc. This means that the object O, for example a battery in the form of a coin cell 98, may allow for a gas (e.g. air) flow or flow 32 that is much higher than the gas flow 32 associated with the apparatus shown in FIG. 6 . A gas flow 36 from the openings 21-1 to 21-4 etc., 22-1 to 22-4 etc. through the suction channels 23-1 to 23-4 etc.; 24-1 to 24-4 etc. into the inlet portions of the main channels 25-1, 25-2, respectively. The gas flow 36 shown in Figure 7 can be much higher compared to the gas flow 36 shown in Figure 6 (see the thick arrows used in Figure 7). - A gas flow 38 entering the hoses 40-1, 40-2 from the outlet portions of the main channels 25-1, 25-2, respectively. Further gas flow (not shown) through hoses 40-1, 40-2, any connections and / or valves to a negative pressure source (also not shown).
[0175] The resulting suction force 35 may be relatively low, for example, when compared to the suction force 34 associated with the embodiment and apparatus shown in FIG. 6 and described in detail above (see the thin arrows in FIG. 7 used to visualize the suction force 35). Thus, the object O (e.g., coin cell 98) is not held, or is held only with a relatively low holding force (e.g., lower than the force acting on the object O / coin cell 98 by gravity), in the orientation shown in FIG. 7 , for example, where the first normal vector 74 of the first surface 64 (e.g., the positive electrode PE) is pointed away from the holding device 10. The second normal vector 84 of the second surface 68 (e.g., the negative electrode ME) is pointed toward the holding device 10. Thus, it is not possible to transport the object O, e.g., coin cell 98, to an assembly location, for example, to the end of the drug delivery device 100 or another application device, e.g., the electronic module EM or the dose knob 116.
[0176] 8 shows a flow diagram of a method 200 for providing an object O, for example a coin cell 98, in its correct orientation for use in an application device 90 (see FIGS. 2 and 3) for the object O. A method for assembling a drug delivery device 100 or an electronic module EM for a drug delivery device 100 includes: - using or providing a holding device 10 according to any one of the above-mentioned embodiments or a holding system as described above, placing 240 an object O, 98 in a holding device 10, When the first side 62 faces the at least one opening 21-1 to 21-4; 22-1 to 22-4 (e.g., in the correct orientation), the object O can be held in the holding device 10, When the second side 66 faces at least one of the openings 21-1 to 21-4; 22-1 to 22-4 (e.g., in the wrong orientation), the object O or another object O may fall out of the holding device 10. 240 to be placed, - Preferably, transporting or transferring 260 the object O, 98 to the assembly position. Alternatively, other components to be assembled can be transported or transferred to a position below the holding device 10. The object O, 98 will in the meantime only be held in the holding device 10 if it is placed in the holding device 10 in the correct orientation (see for example Figure 6). Otherwise, i.e. if it is placed in the holding device 10 in the wrong orientation (see for example Figure 7), the object O, 98 will in the meantime fall out of the holding device 10. - using the holding device 10 to release the object O, 98, for example by turning off or reducing the absolute value of the negative gas (e.g. air) pressure, and positioning 270 the object O, 98 in or on an object receiving space in the drug delivery device 100 or in the electronic module EM; may include:
[0177] More specifically, method 200 may begin at step 210. At step 220, an object orientation sensitive holding device 10 may be provided for selectively holding an object O, 98 according to an orientation 74, 84 of the object O, 98 relative to the holding device 10. For example, the object orientation sensitive holding device 10 may be the holding device 10 shown in Figures 4-7.
[0178] In step 230, the holding device 10 may be set to an operational state. The object orientation-sensitive holding device 10 may include a holding space 18 (storage area) adapted to accommodate an object O, 98 in a first orientation 74 relative to the holding device 10 or in a second orientation 84 relative to the holding device 10. Herein, the holding device 10 may be adapted to selectively retain the object O, 98 in the holding space 18 when the object O, 98 is accommodated in the holding space 18 in the first orientation 74 of the object O, 98 (as shown in FIG. 6 ) during operation of the holding device 10. Conversely, the holding device 10 may be adapted not to retain the object O, 98 in the holding space 18 when the object O, 98 is accommodated in the holding space 18 in the second orientation 84 of the object O, 98 (as shown in FIG. 7 ) during operation of the holding device 10. The negative pressure source may be turned on or negative pressure may be applied by controlling each valve of the holding system as described above.
[0179] In step 240, a new object O, 98 may be placed in the holding space 18 (receiving area) of the holding device 10, with the object O, 98 in one of the first orientation 74 and the second orientation 84 relative to the holding device 10. For example, the object O, 98 may be a coin cell battery O, 98, and the application device 90 may be a dose knob 116 or an electronic module EM as shown in Figures 2 and 3.
[0180] If the object O, 98 is not held within the holding space 18 (receiving area) and falls therefrom (i.e., step 250, N), the method flow may return to step 240. This may be seen as an implicit confirmation that the object O, 98 is positioned in the holding device 10 in the correct orientation.
[0181] Step 240 is performed with the same object O, 98 in the other orientation or with a new object O, 98 in the correct orientation, e.g., the same object O, 98 or a new object O, 98 is placed in the holding space 18.
[0182] If the object O,98 is held in the holding space 18 (i.e. step 250, Y), the method flow may proceed to step 260, where the object O,98 may be transferred from the holding space 18 of the object orientation sensitive holding device 10 to a new application device 90 for the object O,98, for example an electronic module EM. As already mentioned above, alternatively or additionally, the device to be assembled may also be transferred or transported to a position below the holding device 10.
[0183] In step 270, the negative gas (air) pressure may be turned off, for example to release the object O, 98 from the holding device 10. The object O, 98 may be placed directly in the device / module to be assembled, for example at its final assembly location and assembly position. Further, the object O, 98 may be assembled in the same manner. Method 200 may end in step 280.
[0184] Method 200 may include at least one intermediate step not described. Additionally, other variations of method 200 are possible.
[0185] List of drugs The terms "drug" or "medicament" are used synonymously herein to refer to a pharmaceutical formulation containing one or more active pharmaceutical ingredients or pharmaceutically acceptable salts or solvates thereof, and, optionally, a pharmaceutically acceptable carrier. An active pharmaceutical ingredient ("API"), in its broadest sense, is a chemical structure that has a biological effect on humans or animals. In pharmacology, drugs or medications are used to treat, cure, prevent, or diagnose disease or otherwise improve physical or mental well-being. Drugs or medications may be used for a limited period of time or periodically for chronic conditions.
[0186] As described below, drugs or pharmaceutical agents can include at least one API or a combination thereof in various types of formulations for the treatment of one or more diseases. Examples of APIs include small molecules, i.e., polypeptides, peptides, and proteins (e.g., hormones, growth factors, antibodies, antibody fragments, and enzymes) with a molecular weight of 500 Da or less, carbohydrates and polysaccharides, as well as nucleic acids, double-stranded or single-stranded DNA (including naked and cDNA), RNA, antisense nucleic acids such as antisense DNA and RNA, small interfering RNA (siRNA), ribozymes, genes, and oligonucleotides. Nucleic acids can be incorporated into molecular delivery systems such as vectors, plasmids, or liposomes. Mixtures of one or more drugs are also contemplated.
[0187] The drug or agent may be contained within a primary package or "drug container" adapted for use with a drug delivery device. The drug container may be, for example, a cartridge, syringe, reservoir, or other sturdy or flexible vessel configured to provide a chamber suitable for storage (e.g., short-term or long-term storage) of one or more drugs. For example, in some cases, the chamber may be designed to store the drug for at least one day (e.g., from one day to at least 30 days). In some cases, the chamber may be designed to store the drug for about one month to about two years. Storage may occur at room temperature (e.g., about 20°C) or at refrigerated temperatures (e.g., from about -4°C to about 4°C). In some cases, the drug container may be or include a dual-chamber cartridge configured to separately store two or more components of a pharmaceutical formulation to be administered (e.g., an API and a diluent, or two different drugs), one in each chamber. In such cases, the two chambers of the dual-chamber cartridge may be configured to allow mixing of the two or more components prior to and / or during administration to the human or animal body. For example, the two chambers may be configured so that they are in fluid communication with each other (e.g., by a conduit between the two chambers), allowing the user to mix the two components if desired prior to administration. Alternatively, or additionally, the two chambers may be configured to allow mixing upon administration of the components into the human or animal body.
[0188] Drugs or agents contained in drug delivery devices as described herein can be used to treat and / or prevent many different types of medical disorders. Examples of disorders include, for example, diabetes mellitus or complications associated with diabetes mellitus, such as diabetic retinopathy, and thromboembolic disorders, such as deep vein thromboembolism or pulmonary thromboembolism. Further examples of disorders include acute coronary syndrome (ACS), angina pectoris, myocardial infarction, cancer, macular degeneration, inflammation, hay fever, atherosclerosis, and / or rheumatoid arthritis. Examples of APIs and drugs are those listed in handbooks such as the Rote Liste 2014, including, but not limited to, Main Group 12 (antidiabetic drugs) or 86 (oncology drugs), and the Merck Index, 15th edition.
[0189] Examples of APIs for the treatment and / or prevention of type 1 or type 2 diabetes mellitus or complications of type 1 or type 2 diabetes mellitus include insulin, e.g., human insulin, or an insulin analog or derivative, glucagon-like peptide (GLP-1), a GLP-1 analog or GLP-1 receptor agonist, or an analog or derivative thereof, a dipeptidyl peptidase-4 (DPP4) inhibitor, or a pharmaceutically acceptable salt or solvate thereof, or any mixture thereof. As used herein, the terms "analog" and "derivative" refer to a polypeptide having a molecular structure that is formally derivable from the structure of a naturally occurring peptide, e.g., the structure of human insulin, by deleting and / or replacing at least one amino acid residue occurring in the naturally occurring peptide and / or by adding at least one amino acid residue. The added and / or replaced amino acid residue may be either a codable amino acid residue or another naturally occurring residue, or a purely synthetic amino acid residue. Insulin analogs are also referred to as "insulin receptor ligands." In particular, the term "derivative" refers to a polypeptide having a molecular structure formally derivable from that of a naturally occurring peptide, such as the structure of human insulin, in which one or more organic substituents (e.g., fatty acids) are attached to one or more of the amino acids. Optionally, one or more amino acids present in the naturally occurring peptide may be deleted and / or substituted with other amino acids, including non-codable amino acids, or amino acids, including non-codable amino acids, may be added to the naturally occurring peptide.
[0190] Examples of insulin analogues are Gly(A21), Arg(B31), Arg(B32) human insulin (insulin glargine); Lys(B3), Glu(B29) human insulin (insulin glulisine); Lys(B28), Pro(B29) human insulin (insulin lispro); Asp(B28) human insulin (insulin aspart); human insulin in which the proline in position B28 can be replaced by Asp, Lys, Leu, Val or Ala and in position B29 Lys can be replaced by Pro; Ala(B26) human insulin; Des(B28-B30) human insulin; Des(B27) human insulin and Des(B30) human insulin.
[0191] Examples of insulin derivatives are, for example, B29-N-myristoyl-des(B30) human insulin, Lys(B29)(N-tetradecanoyl)-des(B30) human insulin (insulin detemir, Levemir®); B29-N-palmitoyl-des(B30) human insulin; B29-N-myristoyl human insulin; B29-N-palmitoyl human insulin; B28-N-myristoylLysB28ProB29 human insulin; B28-N-palmitoyl-LysB28ProB29 human insulin; B30-N-myristoyl-ThrB29LysB30 human insulin. B29-N-palmitoyl-ThrB29LysB30 human insulin; B29-N-(N-palmitoyl-gamma-glutamyl)-des(B30) human insulin, B29-N-omega-carboxypentadecanoyl-gamma-L-glutamyl-des(B30) human insulin (insulin degludec, Tresiba®); B29-N-(N-lithocholyl-gamma-glutamyl)-des(B30) human insulin; B29-N-(ω-carboxyheptadecanoyl)-des(B30) human insulin, and B29-N-(ω-carboxyheptadecanoyl) human insulin.
[0192] Examples of GLP-1, GLP-1 analogs and GLP-1 receptor agonists are, for example, lixisenatide (Lyxumia®), exenatide (exendin-4, Byetta®, Bydureon®, a 39 amino acid peptide produced by the salivary glands of the Gila monster), liraglutide (Victoza®), semaglutide, taspoglutide, albiglutide (Syncria®), dulaglutide (Trulicity®), rexendin-4, CJC-1134-PC, PB-1023, TTP-054, langrenatide / HM-11260C (efpegrenatide), HM-15211 , CM-3, GLP-1 Erigen, ORMD-0901, NN-9423, NN-9709, NN-9924, NN-9926, NN-9927, Nodexene, Viador-GLP-1, CVX-096, ZYOG-1, ZYD-1, GSK-2374697, DA-3091, MAR-701, MAR709, ZP-2929, ZP-3022, ZP-DI-70, TT-401 (pegapamodtide), BHM-034, MOD-6030, CAM-2036, DA-15864, ARI-2651, ARI-2255, tirzepatide (LY32O176), bamadutide (SAR425899), exenatide-XTEN, and glucagon-Xten.
[0193] An example of an oligonucleotide is mipomersen sodium (Kynamro®), a cholesterol-lowering antisense therapeutic agent for the treatment of familial hypercholesterolemia, or RG012 for the treatment of Alport syndrome.
[0194] Examples of DPP4 inhibitors are linagliptin, vildagliptin, sitagliptin, denagliptin, saxagliptin, berberine.
[0195] Examples of hormones include pituitary hormones or hypothalamic hormones or regulatory active peptides such as gonadotropins (follitropin, lutropin, chorion gonadotropin, menotropin), somatropin (somatropin), desmopressin, terlipressin, gonadorelin, triptorelin, leuprorelin, buserelin, nafarelin and goserelin, and their antagonists.
[0196] Examples of polysaccharides include glycosaminoglycans, hyaluronic acid, heparin, low molecular weight heparin, or ultra-low molecular weight heparin, or derivatives thereof, or sulfated forms of the above polysaccharides, such as polysulfated forms, and / or pharmaceutically acceptable salts thereof. An example of a pharmaceutically acceptable salt of polysulfated low molecular weight heparin is enoxaparin sodium. An example of a hyaluronic acid derivative is Hylan GF 20 (Synvisc®), sodium hyaluronate.
[0197] As used herein, the term "antibody" refers to an immunoglobulin molecule or an antigen-binding portion thereof. Examples of antigen-binding portions of immunoglobulin molecules include F(ab) and F(ab')2 fragments that retain antigen-binding ability. An antibody may be a polyclonal antibody, a monoclonal antibody, a recombinant antibody, a chimeric antibody, a deimmunized or humanized antibody, a fully human antibody, a non-human (e.g., murine) antibody, or a single-chain antibody. In some embodiments, an antibody has effector function and is capable of fixing complement. In some embodiments, an antibody has reduced or no binding ability to Fc receptors. For example, an antibody may be an isotype or subtype, antibody fragment, or mutant that does not support Fc receptor binding, e.g., with a mutation or deletion of the Fc receptor binding region. The term antibody also includes antigen-binding molecules based on tetravalent bispecific tandem immunoglobulins (TBTIs) and / or dual variable region antibody-like binding proteins with a crossover binding region orientation (CODV).
[0198] The term "fragment" or "antibody fragment" refers to a polypeptide derived from an antibody polypeptide molecule (e.g., an antibody heavy and / or light chain polypeptide) that does not include the full-length antibody polypeptide but comprises at least a portion of the full-length antibody polypeptide that is still capable of binding to antigen. Antibody fragments can include truncated portions of a full-length antibody polypeptide, although the term is not limited to such truncated fragments. Antibody fragments useful in the present invention include, for example, Fab fragments, F(ab')2 fragments, scFv (single-chain Fv) fragments, linear antibodies, monospecific or multispecific antibody fragments, such as bispecific, trispecific, tetraspecific, and multispecific antibodies (e.g., diabodies, triabodies, tetrabodies), monovalent or multivalent antibody fragments, such as bivalent, trivalent, tetravalent, and multivalent antibodies, minibodies, chelating recombinant antibodies, tribodies or bibodies, intrabodies, nanobodies, small modular immunopharmaceuticals (SMIPs), binding domain immunoglobulin fusion proteins, camelized antibodies, and VHH-containing antibodies. Additional examples of antigen-binding antibody fragments are known in the art.
[0199] The term "complementarity determining region" or "CDR" refers to short polypeptide sequences within the variable regions of both heavy and light chain polypeptides that are primarily responsible for mediating specific antigen recognition. The term "framework region" refers to amino acid sequences within the variable regions of both heavy and light chain polypeptides that are not CDR sequences but are primarily responsible for maintaining the proper orientation of the CDR sequences to enable antigen binding. Although the framework regions themselves typically do not directly participate in antigen binding, as is known in the art, certain residues within the framework regions of a particular antibody can be directly involved in antigen binding or can affect the ability of one or more amino acids in the CDRs to interact with the antigen.
[0200] Examples of antibodies are anti-PCSK-9 mAb (e.g., alirocumab), anti-IL-6 mAb (e.g., sarilumab), and anti-IL-4 mAb (e.g., dupilumab).
[0201] Further examples of APIs for the prevention of hemophilia A or B, with or without inhibitors, include siRNAs that target antithrombin. One example of an siRNA that targets antithrombin is fitusiran. The terms "prevention" and "prophylactic treatment" are used interchangeably herein.
[0202] Pharmaceutically acceptable salts of any of the APIs described herein are also contemplated for use in the drug or medicament within the drug delivery device. Pharmaceutically acceptable salts include, for example, acid addition salts and base salts.
[0203] It will be understood by those skilled in the art that modifications (addition and / or deletion) of various components of the APIs, formulations, devices, methods, systems and embodiments described herein may be made without departing from the full scope and spirit of the invention, and that the invention encompasses all such modifications and any and all equivalents thereof.
[0204] An exemplary drug delivery device may include a needle-based injection system as described in Table 1 of Section 5.2 of ISO 11608-1:2014(E). As described in ISO 11608-1:2014(E), needle-based injection systems may be broadly divided into multi-dose container systems and single-dose (partial or full discharge) container systems. The container may be a replaceable container or an integrated, non-replaceable container.
[0205] As further described in ISO 11608-1:2014(E), a multi-dose container system may include a needle-based injection device with replaceable containers. In such a system, each container holds multiple doses and the size may be fixed or variable (pre-set by the user). Another multi-dose container system may include a needle-based injection device with an integrated non-replaceable container. In such a system, each container holds multiple doses and the size may be fixed or variable (pre-set by the user).
[0206] As further described in ISO 11608-1:2014(E), a single-dose container system may include a needle-based injection device with replaceable containers. In one example of such a system, each container holds a single dose, thereby discharging the entire deliverable amount (full discharge). In a further example, each container holds a single dose, thereby discharging a portion of the deliverable amount (partial discharge). Also as described in ISO 11608-1:2014(E), a single-dose container system may include a needle-based injection device with an integrated, non-replaceable container. In one example of such a system, each container holds a single dose, thereby discharging the entire deliverable amount (full discharge). In a further example, each container holds a single dose, thereby discharging a portion of the deliverable amount (partial discharge).
[0207] Although the embodiments and advantages of the present disclosure have been described in detail, it should be understood that various changes, substitutions, and alterations can be made therein without departing from the spirit and scope of the present disclosure, as defined by the appended claims. For example, those skilled in the art will readily understand that many of the features, functions, processes, and methods described herein can be modified while remaining within the scope of the present disclosure. Furthermore, the scope of the present application is not intended to be limited to the particular embodiments of the systems, processes, manufacture, methods, or steps described in the present disclosure. As will be readily apparent to those skilled in the art from the disclosure of the present disclosure, any currently existing or later-developed system, process, manufacture, method, or step that performs substantially the same function or achieves substantially the same result as the corresponding embodiment described herein can be utilized in accordance with the present disclosure. Therefore, the appended claims are intended to include within their scope such systems, processes, methods, or steps. The embodiments described in the first part of the description may be combined with each other. The embodiments described in the figures may also be combined with each other. Furthermore, the embodiments described in the first part of this specification can be combined with the examples in the second part of this specification related to Figures 1-8. [Explanation of symbols]
[0208] 1 device 10. Holding Device 12 first main surface 14 second main surface 16 Cylindrical outer surface 18 Cylindrical holding space 19 Contact area (surface) 20 Lateral Support Surface (Cylindrical Wall) 21-1~21-4 etc. Suction opening 22-1~22-4 etc. Suction opening G1 and G2 groups 23-1~23-4 Suction channel 24-1~24-4 Suction Channel 25-1, 25-2 Main Channels 26-1, 26-2 Negative pressure supply opening 27 Offset structure 28 Offset Surface 29-1~29-3 Gas flow recess (air) 29-4~29-6 Gas flow recess (air) 30 Gas Environment 32 Gas Flow 34, 35 Suction power 36, 38 Gas flow 40-1, 40-2 gas hose 42-1, 42-2 First end O Object (e.g. coin cell) 62 First Aspect 64 First Surface 66 Second Aspect 68 Second Surface PE positive electrode ME negative electrode EM Electronic Module Dr. M Drugs, Medications P proximal D. Distal A-axis H Housing AS alignment structure HS retention structure GTS Gas Transport Structure 74 First normal vector 84 Second normal vector 90 Applicable Devices / Components 91 Base part 92 Circuit Board 93 Negative electrical contact parts (and / or electronic components, capacitors, etc.) 94 Positive Electrical Contact Clamp 95 Positive Electrical Contact Bridge 96 Positive Electrical Contact End 97 Cover part 98 Electrical Components / Coin Cell Batteries / Objects 99 Rotational Axis 100 Injection Device 102 Housing 104 Window 106 Container 108 needles 110 Inner needle cap 112 Outer needle cap 114 Other Caps 116 Dosage knob 118 Injection button 120 Dial or Number Sleeve 200 How to provide the correct orientation of an object 210 start 220 Provide a holding device that is sensitive to the object's orientation 230 Set the device to operational state 240 Place a new object into the containment area of the object orientation sensitive holding device 250 Check if object is being held within containment area 260 Transfer the object from the containment area to a new application device 270 Turn off negative gas pressure 280 End
Claims
1. A holding device (10) for holding an object (O) during assembly of a medical device (100), comprising: a holding structure (HS); an alignment structure (AS); Including, The holding structure (HS) includes at least one opening (21-1 to 21-4; 22-1 to 22-4), the alignment structure (AS) is configured to align the object (O) with respect to the holding structure (HS); the object (O) is a coin cell battery, The object (O) includes a first side (62) and a second side (66) of the object (O) opposite the first side (62); the first side (62) has a first surface configuration that is different from a second surface configuration of the second side (66); the at least one opening (21-1 to 21-4; 22-1 to 22-4) is arranged to apply a negative pressure to the first side of the object (O); the holding device (10) is configured to hold the object (O) using the negative pressure only in a first orientation in which the first side (62) of the object (O) faces the at least one opening (21-1 to 21-4; 22-1 to 22-4), and not in a second orientation in which the second side (66) faces the at least one opening (21-1 to 21-4; 22-1 to 22-4). A holding device (10).
2. the alignment structure (AS) comprises at least one alignment area arranged to laterally align the object (O); the at least one alignment region is provided adjacent to the at least one opening (21-1 to 21-4; 22-1 to 22-4) for holding the object (O) at at least one edge region of the object (O); A holding device (10) according to claim 1.
3. the holding structure (HS) comprises at least one abutment area (19) configured to abut the second side of the object, or alternatively the first side (62) and the second side (66), 3. The holding device (10) according to claim 1 or 2, wherein the at least one opening (21-1 to 21-4; 22-1 to 22-4) is arranged at a different position compared to the at least one abutment area (19), or the at least one opening (21-1 to 21-4; 22-1 to 22-4) is arranged in the at least one abutment area (19).
4. Said different surface configurations have the following characteristics: a) the maximum lateral extent or diameter of the most prominent first surface (64) of said first side (62) is greater than the maximum lateral extent or diameter of the most prominent second surface (68) of said second side (66); b) the surface roughness of the first surface (64) of the first side (62) is smaller than the surface roughness of the second surface (68) of the second side (66); c) a chamfered or rounded peripheral area on said first side (62), while said second side (66) is free of such a peripheral area; d) other physical properties suitable for interacting with the gas flow through said at least one opening (21-1 to 21-4; 22-1 to 22-4) to achieve dedicated retention of said object (O) depending on the orientation of said object (O) relative to said holding device (10); A holding device (10) according to any one of claims 1 to 3, characterized in that at least one of
5. The following characteristics: a) at least one abutment area (19) is arranged to provide an abutment surface for said object (O) in a first direction; the alignment structure (AS) comprises at least one lateral support surface (20) or surface portion configured to align the object (O) in a second direction different from the first direction; b) said holding device (10) comprises a gas transport structure (GTS); the gas transport structure (GTS) comprises at least one channel (23-1 to 23-4; 24-1 to 24-4; 25-1, 25-2) or tube (40-1, 40-2) connected to or connectable to the at least one opening (21-1 to 21-4; 22-1 to 22-4) and configured to be connected to a negative pressure source, A holding device (10) according to any one of claims 1 to 4, comprising at least one of:
6. A housing (H) is included, The holding structure (HS) and the alignment structure (AS) are provided on or within the housing (H), The housing (H) comprises at least a portion of a gas transport structure (GTS), A holding device (10) according to any one of claims 1 to 5.
7. The holding device (10) according to any one of claims 1 to 6, comprising a cylindrical holding space (18) adapted to hold the object (O) and bounded by the holding structure (HS) and the alignment structure (AS).
8. At least one first opening (21-1 to 21-4) of the at least one opening (21-1 to 21-4; 22-1 to 22-4) is arranged at a first location, and at least one second opening (22-1 to 22-4) of the at least one opening (21-1 to 21-4; 22-1 to 22-4) is arranged at a second location; the first location and the second location are located on opposite lateral sides of the holding structure (HS); and / or the holding device (10) is configured so that the object (O) is held by the negative air pressure applied in the first direction by the at least one opening (21-1 to 21-4; 22-1 to 22-4) to the edge region of the object (O) but not applied or only slightly applied to the central region, A holding device (10) according to any one of claims 1 to 7.
9. The Gas Transport Structure (GTS) comprises: a) at least one main channel (25-1, 25-2) connected to at least a portion of said at least one opening (21-1 to 21-4; 22-1 to 22-4); b) a first main channel (25-1) fluidly connected with at least a portion of said at least one opening (21-1 to 21-4) of a first group (G1), and a second main channel (25-2) different from said first main channel (25-1) fluidly connected with at least a portion of said at least one opening (22-1 to 22-4) of a second group (G2); c) at least one gas flow recess (29-1 to 29-3; 29-4 to 29-6) adjacent to said at least one opening (21-1 to 21-4; 22-1 to 22-4), said at least one gas flow recess (29-1 to 29-3; 29-4 to 29-6) being configured such that said gas flow between said at least one gas flow recess (29-1 to 29-3; 29-4 to 29-6) and said at least one opening (21-1 to 21-4; 22-1 to 22-4) is controlled by said object (O) at least one gas flow recess (29-1 to 29-3; 29-4 to 29-6) which is arranged to be essentially restricted by the object (O) when the first side thereof faces the at least one opening (21-1 to 21-4; 22-1 to 22-4) and to be effective when the second side (O) of the object faces at least one of the at least one opening (21-1 to 21-4; 22-1 to 22-4) and the at least one holding area (19). A holding device (10) according to any one of claims 1 to 8, in particular claim 5, comprising at least one of:
10. Alternative c) the at least one gas flow recess (29-1 to 29-3; 29-4 to 29-6) is configured such that, when the second side (66) faces the at least one opening (21-1 to 21-4; 22-1 to 22-4), at least two gas channels are formed between the at least one gas flow recess (29-1 to 29-3; 29-4 to 29-6) and at least two of the at least one opening (21-1 to 21-4; 22-1 to 22-4), the at least two gas channels between the at least one gas flow recess (29-1 to 29-3; 29-4 to 29-6) and the at least two openings (21-1 to 21-4; 22-1 to 22-4) are blocked or at least essentially blocked by the object (O) when the first side (62) faces the at least one opening (21-1 to 21-4; 22-1 to 22-4), A holding device (10) according to claim 9.
11. at least one primary channel (25-1, 25-2) fluidly connected to at least one of the openings (21-1 to 21-4; 22-1 to 22-4) and redirecting the gas flow in the at least one opening (21-1 to 21-4; 22-1 to 22-4) from a first flow direction to a second direction, wherein an angle between the first direction and the second direction is in the range of 80 degrees to 100 degrees; The main channels (25-1, 25-2) are as follows: a) an inlet section comprising at least one inlet opening fluidically connected to a suction channel coming from said at least one opening (21-1 to 21-4; 22-1 to 22-4); b) a pipe or hose offset structure (27) disposed downstream of the inlet portion of the main channel and configured to define an offset between a sidewall of the main channel and a pipe fluidly connected to the main channel; c) an outlet portion including an outlet opening; at least one of At least one primary channel (25-1, 25-2) A holding device (10) according to any one of claims 1 to 10, comprising:
12. A holding device (10) according to any one of claims 1 to 11, A negative pressure source; a connection system configured to connect or to connect said holding device (10) and said negative pressure source; A retention system including:
13. 13. An apparatus (1) comprising a holding device (10) according to any one of claims 1 to 11 or a holding system according to claim 12, and an object (O) configured to be held by the holding system for placing the object (O) in a device during assembly of the device.
14. A method of assembling a drug delivery device (100) or an electronic module (EM) for a drug delivery device (100), comprising: Providing a holding device (100) according to any one of claims 1 to 12 or an apparatus (1) according to claim 13; Placing (240) the object (O) in the holding device (10), the object (O) is held in the holding device (10) when the first side (62) faces the at least one opening (21-1 to 21-4; 22-1 to 22-4); the object (O) or another object (O) falls from the holding device (10) when the second side (66) faces the at least one opening (21-1 to 21-4; 22-1 to 22-4), placing (240); placing (270) the object (O) in or on an object receiving space in the drug delivery device (100) or in the electronic module (EM) using the holding device (10); A method comprising:
15. A drug delivery device (100) manufactured or manufacturable using the method of claim 14, comprising: a container receptacle configured to receive a container (106) containing a medication (Dr, M); an electronic module (EM); Including, said electronic module (EM) being electrically powered by a power source contained in or formed by said object (O), the object (O) is a coin cell battery, a first surface (64) of the object (O) being located more proximally compared to a second surface (68) of the object (O); the first surface (64) is a flat surface having a first maximum lateral extent or diameter; the second surface (68) is a flat surface having a second maximum lateral extent or diameter; the first maximum lateral extent or diameter is greater than the second maximum lateral extent or diameter; The first surface (64) has an opposite electrical polarity compared to the second surface (68). A drug delivery device (100).