User interface member for drug delivery device and drug delivery device - Patents.com

Abstract

The present invention relates to a user interface member (1) for a drug delivery device (100), comprising a light emitting area (2) configured to be illuminated by at least one light emitting element (3, 4) for emitting light from the light emitting area and for visually indicating an operational state of the drug delivery device to a user. The light emitting area comprises two or more sub-areas (23, 24) which can be illuminated independently of one another by at least one light emitting element for presenting different illumination patterns to a user via the light emitting area. The different illumination patterns indicate different operational states of the drug delivery device to a user.

Description

[Technical field]

[0001] A user interface member for a drug delivery device is provided. Further, a drug delivery device is provided. Further, a method of operating a user interface member is provided. [Background technology]

[0002] Administering an injection is a process that poses many risks and challenges, both mentally and physically, for users and medical personnel. Drug delivery devices may aim to make self-injection easier for patients. Drug delivery devices that use electronics are becoming more and more popular not only in the pharmaceutical industry, but also among users or patients. By visually indicating the different operating states of the drug delivery device, the use of the drug delivery device may become easier and more comfortable. Summary of the Invention [Problem to be solved by the invention]

[0003] One object achieved is to provide an improved user interface member for a drug delivery device. Preferably, the user interface member is capable of visually indicating different operating states of the drug delivery device to a user. A further object achieved is to provide an improved drug delivery device and an improved method of operating the user interface member. [Means for solving the problem]

[0004] These objects are achieved, inter alia, by the subject matter of the independent claims. Advantageous embodiments and further developments are the subject matter of the dependent claims, which are also set forth in the following description and in the figures.

[0005] First, the user interface member will be described in detail. The user interface member may be a button and / or knob for operating or activating the drug delivery device. The user interface member may be coupled or coupleable to a drug container holder of the drug delivery device. The user interface member may form the proximal end of the drug delivery device.

[0006] According to at least one embodiment, the user interface member includes a light emitting region configured to be illuminated by at least one light emitting element to emit light from or through the light emitting region, respectively, for example to visually indicate to a user an operational status of the drug delivery device, for example light from the light emitting element is directed to the light emitting region and then emitted from the user interface member via the light emitting region.

[0007] The light-emitting region may be a continuous region of the user interface member. The light-emitting region may be at least partially transparent or translucent, in particular to visible light. In particular, the light-emitting region is transparent or translucent over a large portion of its area, for example at least 60%, or at least 75%, or at least 90% or 100% of its area. For example, the light-emitting region is at least partially, in particular completely, formed from a transparent or translucent material, for example a plastic. The light-emitting region may be ring-shaped.

[0008] The light-emitting region may be formed to be continuously transparent or translucent, or may alternatively comprise, for example, two or more transparent or translucent sub-regions separated from one another by one or more opaque regions.

[0009] The light-emitting area may in particular be an area of ​​the outer surface of a user interface member, for example an area that can be physically touched by a user and / or that can be seen from the outside, in other words, the light-emitting area may be formed by a light-emitting surface that is a partial surface of the outer surface of the user interface member.

[0010] The light emitting region may be the only region of the user interface member that is transparent or semi-transparent to visible light. Other regions of the user interface member, particularly regions of the exterior surface of the user interface member adjacent to the light emitting region, may be opaque, i.e. not transparent or semi-transparent to visible light. During operation of the user interface member, light from the at least one light emitting element is preferably emitted only through the light emitting region.

[0011] "At least one light emitting element" means exactly one or more, for example exactly two or more light emitting elements.

[0012] According to at least one embodiment, the light-emitting region comprises two or more partial regions. The partial regions may be illuminable independently of one another by at least one light-emitting element in order to present different illumination patterns to the user via the light-emitting region. The partial regions may be separated from one another, for example, by opaque or non-illuminated regions, or may be directly adjacent to one another. Each partial region may be transparent or semi-transparent over its entire area, for example completely formed from a transparent or semi-transparent material. In operation, light may be emitted from the user interface member via each of the partial regions. For example, an illuminated partial region emits light over its entire area.

[0013] According to at least one embodiment, the different lighting patterns indicate to a user one or more operational states, e.g., different operational states, of the drug delivery device. For example, the drug delivery device has two or more operational states. The different operational states may be assigned different lighting patterns, e.g., one-to-one, i.e., each state may have a unique lighting pattern assigned to it.

[0014] For example, the operating state may include a first operating state or a pairing state. In this state, the device may attempt to perform (e.g. advertise) a wireless pairing procedure and / or may perform a wireless pairing procedure. The wireless pairing procedure may be configured to pair the drug delivery device or user interface member with the further device, e.g. to create a secure or protected wireless connection between the further device and the drug delivery device or user interface member. Once the pairing procedure is completed, the further device is paired with the user interface member or drug delivery device. The pairing may be temporary, e.g. for only one communication session, or may be permanent, e.g. for multiple separate communication sessions. The paired electronic elements (e.g. the further device and the user interface member or drug delivery device) may advantageously establish a secure communication channel without going through the pairing procedure again, especially if the elements are both operational and one element attempts to connect to the other element. During the pairing procedure, a key for encrypting data transmitted through the channel may be transmitted from one electronic element to the other electronic element, and vice versa. When advertising for pairing or attempting pairing, the electronic element may for example communicate its readiness to be paired with other electronic elements in its vicinity. The pairing procedure may be a Bluetooth pairing procedure. A Bluetooth pairing may be established between the paired electronic elements. Data transmission between the user interface member or drug delivery device and the further device, for example dosage data or information from the user interface member or drug delivery device to the further device, may be restricted to the further device paired with the user interface member or drug delivery device.

[0015] Alternatively or additionally, the operating state may include a second operating state or a transmission or synchronization state. In this state, the drug delivery device or the user interface member may transmit, e.g. synchronize or attempt to transmit, e.g. synchronize, data to a further device, e.g. a further device paired with the drug delivery device or the user interface member. First, the drug delivery device or the user interface member may advertise its intention to transmit data, e.g. dose or dose history data. When the further device is within reach of the communication interface, a (secure) communication channel is established and data can be transmitted, e.g. synchronized. The data may be dose data, e.g. dose history data.

[0016] The illumination pattern of each state may indicate that the drug delivery device or the user interface member is advertising / attempting to pair or transmit. When the pairing or transmission process is running, the light emitting element may not emit light, thereby conserving power.

[0017] The further device may be, for example, a computer, a smartphone or a smartwatch. The user interface member or the drug delivery device may include a wireless communication interface, for example a Bluetooth communication interface. This wireless communication interface may be configured to communicate with the further device. Alternatively or in addition, the operating state may include a third operating state or a warning state, for example a state in which the power stored in a power source of the user interface member or the drug delivery device is nearing the end. Alternatively or in addition, the operating state may include a fourth operating state or a dose adjustment state, in which a drug dose is dialed in and / or a fifth operating state or a dose delivery state, in which a drug dose is delivered, for example injected.

[0018] In at least one embodiment, a user interface member for a drug delivery device includes a light emitting region configured to be illuminated by at least one light emitting element to emit light from the light emitting region and visually indicate an operational state of the drug delivery device to a user. The light emitting region includes two or more sub-regions that are independently illuminable from each other by the at least one light emitting element to present different illumination patterns to a user via the light emitting region. The different illumination patterns indicate different operational states of the drug delivery device to a user.

[0019] Light emitting elements such as LEDs may be used in electronic devices to indicate a status to a user, for example an on / off state or a standby state. Colors may be incorporated, for example green to indicate ready and red to indicate not ready, while letters and / or symbols adjacent to the LED may provide further information.

[0020] As a medical device, regulations and standards limit the use of some colors to specified conditions or prohibit the use of other colors for patient safety reasons. Furthermore, color vision deficiencies in a certain percentage of the user population can cause confusion when some color combinations are used.

[0021] The user interface members detailed herein allow the operational state of the drug delivery device to be communicated by means other than color, i.e., by different illumination patterns. This is achieved by using a light emitting area having two or more sub-areas that can be illuminated independently of each other.

[0022] The user interface members and / or drug delivery devices detailed herein may be elongate and / or include a longitudinal axis, e.g., a main axis of elongation. Additionally or alternatively, the user interface members and / or drug delivery devices may have rotational symmetry about the longitudinal axis. A direction parallel to the longitudinal axis is referred to herein as the axial direction. By way of example, the drug delivery device and / or user interface members may be cylindrical.

[0023] Furthermore, the drug delivery device may include an end, e.g. a longitudinal end, that may be arranged to face or be pressed against a skin area of ​​the human body. This end is referred to herein as the distal end. A drug or agent may be delivered via the distal end. The opposite end is referred to herein as the proximal end. The proximal end is away from the skin area during use. The axial direction pointing from the proximal end to the distal end is referred to herein as the distal direction. The axial direction pointing from the distal end to the proximal end is referred to herein as the proximal direction. The distal end of a member or element or feature of a drug delivery device, e.g. a user interface member, is understood herein to be the end of the most distally located member / element / feature. Thus, the proximal end of a member or element or feature is understood herein to be the end of the most proximal located member / member / feature.

[0024] In other words, distal is used herein to designate a direction, end or surface that is arranged or positioned to face or orient towards the dosing end of the drug delivery device or a component thereof and / or that faces away from the proximal end. On the other hand, "proximal" is used herein to designate a direction, end or surface that is arranged or positioned to face or orient away from the dosing end and / or the distal end of the drug delivery device or a component thereof. The distal end may be the end closest to the dosing end and / or the end furthest from the proximal end, and the proximal end may be the end furthest from the dosing end. The proximal face may face away from the distal end and / or towards the proximal end, and the distal face may face towards the distal end and / or away from the proximal end. The dosing end may be, for example, the needle end at which the needle unit is attached or attached to the device.

[0025] Directions perpendicular to and / or intersecting the longitudinal axis are referred to herein as radial. Radially inward is a radial direction that points toward the longitudinal axis. Radially outward is a radial direction that points away from the longitudinal axis. The terms "angular", "azimuthal" or "rotational" are used synonymously herein. Such directions are perpendicular to the longitudinal axis and perpendicular to the radial direction.

[0026] According to at least one embodiment, the user interface member includes at least one light emitting element. The light emitting element may be a light emitting diode, LED for short. Other light emitting elements are also possible, for example electroluminescent elements such as light emitting foils. The light emitting element may be configured to emit white light. In particular, the user interface member may be configured such that light generated by the light emitting element is directed onto the light emitting area to emit light through the light emitting area.

[0027] The user interface member may further include an energy source, such as a cell or battery, for powering the at least one light-emitting element. The at least one light-emitting element may be mounted on a carrier, such as a PCB, such as a flexible PCB. The light-emitting element may be electrically connected through the carrier.

[0028] According to at least one embodiment, the user interface member is configured to operate the at least one light emitting element depending on an operational state of the drug delivery device to present different illumination patterns to a user via the light emitting region, for example, the user interface member is configured to operate the light emitting element in a flashing mode and / or a continuous mode.

[0029] To operate the light-emitting elements, the user interface member may include a control unit configured to control the light-emitting elements. The control unit may be mounted on the same carrier as the light-emitting elements.

[0030] According to at least one embodiment, the light emitting element is a sidelooker, which is a light emitting element that emits light substantially parallel to a mounting surface on which the light emitting LED is mounted and / or has a radiation exit side that extends obliquely or perpendicularly to the mounting surface.

[0031] According to at least one embodiment, the user interface member includes two or more light emitting elements. For example, the user interface member includes exactly two light emitting elements. All features disclosed herein for one light emitting element are also disclosed for the other light emitting element. In particular, all light emitting elements can be LEDs, for example sidelooker LEDs.

[0032] According to at least one embodiment, the light emitting elements emit light of the same color, for example, the light emitting elements emit white light.

[0033] According to at least one embodiment, each light emitting element is assigned to one partial region. Preferably, each light emitting element is assigned to one partial region on a one-to-one basis. For example, a large portion of the light generated by the light emitting element, for example at least 75% or at least 90% of the generated light or even all of the generated light, is directed to the assigned partial region and then emitted from the user interface member via the assigned partial region.

[0034] According to at least one embodiment, the partial regions of the light-emitting region are arranged to emit light in different directions, in particular in opposite directions. For example, the partial regions are arranged to emit light in opposite radial directions. For example, the partial regions are arranged on different or opposite sides of the user interface member. Thus, during operation of the user interface member, light emitted from the different partial regions can be emitted in different or opposite directions, in particular in opposite radial directions.

[0035] According to at least one embodiment, the two light emitting elements are arranged to emit light in different, e.g., opposite, directions during operation, e.g., the light emitting elements are arranged to emit in opposite radial directions.

[0036] According to at least one embodiment, the user interface member is configured to operate the light emitting elements depending on an operational state of the drug delivery device to present different illumination patterns to a user via the light emitting regions. For example, the user interface member is configured to operate different light emitting elements individually and / or independently of each other. For example, the user interface member is configured to operate each of the light emitting elements in a flashing mode and / or a continuous mode.

[0037] According to at least one embodiment, the different lighting patterns include one or more of a first lighting pattern, a second lighting pattern, a third lighting pattern, and a fourth lighting pattern.

[0038] According to at least one embodiment, the first lighting pattern is a lighting pattern in which light is emitted simultaneously from at least two different partial areas, for example all partial areas, in a continuous or flashing mode over a predefined period of time.

[0039] In this specification, continuous mode means that light is emitted from each sub-region so that it appears to the user as being emitted continuously during a predetermined time or a certain time window, i.e. without interruption. In this specification, blinking mode is understood to be a mode in which flashes are emitted periodically during a predetermined time. For example, at least two flashes or at least five flashes are emitted during a predetermined time. Between two flashes, no light or less light is emitted from each sub-region so that the user perceives it. For example, in blinking mode, the flashes are less than 1 second in time, for example 100 ms long. For example, in blinking mode, the frequency of occurrence of the flashes is at least 0.5 Hz, for example 1 Hz.

[0040] According to at least one embodiment, the second lighting pattern is a lighting pattern in which light is emitted from at least two different partial regions in an alternating manner over a predefined time period. This means that a first partial region emits light, for example in a continuous or blinking mode, over a certain time window, for example less than 2 seconds or less than 1 second, for example 100 ms, during which at least another partial region emits no light or emits less light. Then, another partial region emits light, for example in a continuous or blinking mode, over a certain time window, and the first partial region emits no light or emits less light during this time window. The alternation is performed, for example, at a frequency of at least 0.5 Hz.

[0041] According to at least one embodiment, the third lighting pattern is a lighting pattern in which light is emitted from one sub-region for a predefined time, for example in a continuous or flashing mode, while another sub-region emits no light or less light during the predefined time, for example the other sub-region is switched off for the entire predefined time.

[0042] According to at least one embodiment, the fourth illumination pattern is an illumination pattern in which light of different intensities is emitted from different partial regions over a given time, for example a first partial region emits light with a higher intensity than a second partial region over a given time, for example an intensity that is at least twice as high as the intensity of the second partial region.

[0043] The predetermined time period may be, for example, at least 0.5 seconds, or at least 1 second, or at least 2 seconds. Additionally or alternatively, the predetermined time period may be at most 20 seconds, or at most 10 seconds, or at most 5 seconds.

[0044] Other lighting patterns can be realized as well: by using more partial areas and / or more light emitting elements, more lighting patterns are possible.

[0045] According to at least one embodiment, the user interface member is configured to present two or more, or each, of the above-mentioned lighting patterns, each of which may be assigned, for example on a one-to-one basis, a different operational state of the drug delivery device.

[0046] According to at least one embodiment, the user interface member has a cylindrical shape. In particular, an outer surface for gripping or manipulating the user interface member, for example for dose setting or dial setting, may have a cylindrical shape. Additionally or alternatively, the user interface member may have rotational symmetry about the longitudinal axis.

[0047] According to at least one embodiment, the user interface member has a lateral surface. The lateral surface may be an outer surface configured to be touched by a user. The lateral surface may define the user interface member radially outward. In particular, the lateral surface may extend parallel or at an acute angle to the longitudinal axis. The lateral surface may be provided to be touched for a dose setting operation.

[0048] The lateral surface may be configured to be held by a user using two fingers to effect rotation of the user interface member about the longitudinal axis.

[0049] Alternatively or additionally, the user interface member may further include a proximal surface facing in a proximal direction. The proximal surface may extend perpendicularly or obliquely to the longitudinal axis and / or the lateral surface. The proximal surface may be configured for a user to touch using only one finger, e.g., a thumb. The proximal surface may be configured, for example, such that a user touches the surface to push the user interface member in a distal direction. The proximal surface may be provided to be touched for a dose delivery operation.

[0050] According to at least one embodiment, the lateral surface may include gripping features, such as grooves. The grooves may extend parallel to the longitudinal axis or at an acute angle. The gripping features may simplify gripping and / or manipulation of the user interface member by a user.

[0051] According to at least one embodiment, the light emitting area extends circumferentially on an outer surface of the user interface member. The light emitting area may be formed on or adjacent to a lateral surface of the user interface member.

[0052] "Circumferentially extending" can particularly mean that the light emitting region extends around, for example all the way around, the longitudinal axis. For example, the light emitting region forms a closed loop around the longitudinal axis.

[0053] According to at least one embodiment, the light emitting region forms an edge between the lateral and proximal surfaces of the user interface member, for example, the light emitting region forms a transition region between the lateral and proximal surfaces.

[0054] According to at least one embodiment, the light emitting surface forming the light emitting region extends obliquely with respect to the longitudinal axis and / or the lateral and / or proximal surface. For example, the angle between the light emitting surface and the longitudinal axis and / or the lateral and / or proximal surface is at least 10° or at least 20° or at least 30°. Additionally or alternatively, the angle may be at most 80°, or at most 70°, or at most 60°.

[0055] According to at least one embodiment, the light-emitting area or the light-emitting surface forming the light-emitting area, respectively, has a linear shape. This means that the length of the light-emitting area is much larger than the width of the light-emitting area, for example at least 5 times or at least 10 times the width. For example, the width of the light-emitting area is at most 5 mm or at most 2 mm.

[0056] The light-emitting region may in particular have a curved linear shape and / or a shape with a variable extension. For example, the light-emitting region is ring-shaped. The partial regions may be formed as segments of the ring.

[0057] According to at least one embodiment, the user interface member further includes a light distribution element. The light distribution element may have a light input side and a light output side. The light distribution element may be configured to receive light from the light emitting element at or via the light input side and transmit the light to the light output side. The light may exit the light distribution element via the light output side. The light output side may be assigned to a light emitting area.

[0058] The light distribution element may be a solid body. For example, the light distribution element may be formed of a single piece or may be integrally formed. The light input side and / or the light output side may be surfaces, such as opposing surfaces, of the light distribution element. The light distribution element may be formed of a transparent or translucent material, such as plastic.

[0059] The light output side may face the light emitting area or form the light emitting area or surface, respectively. In other words, the light output side of the light distributing element may form part of the outer surface of the user interface member. In particular, the light output side may be ring-shaped and / or may define the light distributing element in the outward and / or radial direction.

[0060] At least one light-emitting element may be arranged on the user interface member such that the radiation output side of the light-emitting element faces the light input side of the light distribution element, e.g., such that a majority of the light emitted by the light-emitting element is coupled into the light distribution element via the light input side.

[0061] According to at least one embodiment, the user interface member includes a gripping element. The gripping element may be formed from plastic. The gripping element may be opaque to the light of the light emitting element. The gripping element may form a majority of a lateral surface of the user interface member, for example at least 75% or at least 90% of the area of ​​the lateral surface. For example, the gripping element has a hollow cylindrical shape. The gripping element may be formed in one piece.

[0062] According to at least one embodiment, the user interface member includes a cover element. The cover element may be formed in one piece and / or may be opaque to the light of the light emitting element and / or may be formed of plastic. The cover element may form a proximal surface of the user interface member.

[0063] According to at least one embodiment, the light-emitting area is disposed between the cover element and the gripping element, for example in the axial direction. In particular, the light-distributing element is disposed between the gripping element and the cover element, for example in the axial direction. The light-distributing element can be form-fitted and / or adhesively connected to the gripping element. The cover element can be form-fitted and / or adhesively connected to the light-distributing element and / or the gripping element. Alternatively, two of the components, for example the cover element and the light-distributing element, are twin-shot molded. However, the same functional shape can be formed using any combination of twin-shot molding, gluing, clipping, welding, etc. between any of the three individual components.

[0064] According to at least one embodiment, the light distribution element includes a further surface. The light distribution element may be arranged with respect to the gripping element such that the further surface faces or abuts an inner surface of the gripping element. The inner surface of the gripping element may be a surface facing longitudinally or radially inward, respectively. For example, the further surface is covered by the gripping element in a radial direction. The further surface may define the light distribution element radially outward and / or may be ring-shaped.

[0065] According to at least one embodiment, the light distributing element has the shape of a plate, which in particular means that the light distributing element is essentially formed as a plate, for example the light distributing element is disk-shaped.

[0066] According to at least one embodiment, the light distributing element has a main extension surface, where the thickness of the light distributing element measured perpendicularly to the main extension surface may be, for example, at least 5 or 10 times smaller than the extension of the light distributing element along the main extension surface. The light distributing element may be arranged such that the main extension surface of the light distributing element extends obliquely or perpendicularly to the longitudinal axis and / or the lateral plane.

[0067] According to at least one embodiment, the light output side of the light distribution element is formed by a surface of the light distribution element that extends obliquely or perpendicularly to the main extension plane of the light distribution element. Additionally or alternatively, the light input side is formed by a surface of the light distribution element that extends obliquely or perpendicularly to the main extension plane of the light distribution element. During operation, light can be transmitted or guided within the light distribution element from the light input side to the light output side, for example parallel or substantially parallel to the main extension plane of the light distribution element.

[0068] According to at least one embodiment, the light distribution element has at least two subsections. Each subsection can be assigned to one partial region of the light-emitting region, for example, one-to-one. For example, each subsection comprises a part of the light-emitting side, which part of the light-emitting side faces or forms the assigned partial region. The subsections can be separated from each other by one or more structures, for example grooves or recesses, in the light distribution element. For example, the subsections are formed symmetrically with respect to mirroring in the longitudinal axis. The structures can be radially oriented or extend radially, respectively.

[0069] According to at least one embodiment, the two subsections are optically separated from each other. For example, light coupled into the light distribution element of one subsection via the light input side is prevented from reaching the other subsection, for example due to internal reflection within the light distribution element. For example, the light distribution element includes one or more reflective surfaces or interfaces that optically separate the two subsections. The reflective surfaces or interfaces may extend in a radial direction.

[0070] According to at least one embodiment, e.g. instead of or in addition to structures separating the subsections, the light distribution element may be configured such that light from one light-emitting element is guided, e.g. at least largely or entirely, to a first partial region, e.g. a region on the light output side and / or with an angular spread of more than 120° and / or less than or equal to 180°. Light from a further light-emitting element is guided, e.g. at least largely or entirely, to a second partial region, preferably with an angular spread of more than 120° and / or less than or equal to 180°. The first partial region and the second partial region may be angularly adjacent to each other.

[0071] According to at least one embodiment, a recess is formed in the light distributing element. For example, the recess is formed in the center of the light distributing element. The longitudinal axis may extend through the recess.

[0072] According to at least one embodiment, the recess is a hole, which may extend completely through the light distributing element, for example axially and / or perpendicularly to a main extension plane of the light distributing element.

[0073] According to at least one embodiment, the recess is configured to receive at least one light emitting element. In other words, the recess is sized such that at least one light emitting element, preferably two or more light emitting elements, can be disposed inside the recess. A light emitting element of a user interface member can be disposed within the recess.

[0074] According to at least one embodiment, the light entry side is adjacent to or defines a recess, for example, the light entry side circumferentially surrounds the recess, in particular, the light entry side may define a recess radially outward.

[0075] According to at least one embodiment, the light distribution element is configured to guide light from the light inlet side to the light outlet side by reflection and / or refraction. By way of example, the light is guided in the light distribution element by non-imaging optics. For example, each subsection of the light distribution element includes or is defined by a structure configured to guide light from the light inlet side towards the assigned partial region by reflection and / or refraction. The structures may be radially oriented or extend radially, respectively. The structures may be surfaces or interfaces of the light distribution element, for example material-air interfaces. The light distribution element may be a plastic component, for example a molded plastic component.

[0076] According to at least one embodiment, the user interface member is a button and / or knob for the drug delivery device. The user interface member may be configured to be rotated and / or axially moved and / or pressed relative to the housing of the drug delivery device. The user interface member may be configured such that by manipulating it in a first way, e.g. by rotating it, a dose adjustment is initiated or performed, and by manipulating it in a second way, e.g. by moving it axially, an injection process is initiated or performed. Thus, the user interface member may realize a dose adjustment function and an injection function.

[0077] According to at least one embodiment, the user interface member is configured to be manually manipulated by a user to initiate different operational states of the drug delivery device. For example, the user interface member and / or the drug delivery device is configured to set the operational state depending on a time-related feature of the manual manipulation. In particular, different time-related features may be assigned different operational states.

[0078] For example, the user interface member and / or the drug delivery device are configured such that different operating states are initiated by moving the user interface member in the same direction and / or the same distance and / or by holding the user interface member in the same position, but with different time-related characteristics, which may for example be different lengths of time of manipulation of the user interface member and / or different numbers of repetitions of the manipulation.

[0079] According to at least one embodiment, the user interface member is configured to generate different electronic signals depending on how the user interface member is operated, for example depending on a time-related characteristic of the operation. Each of the different electronic signals can be assigned to a different operating state. For example, different electronic signals are generated depending on a time-related characteristic of operating the user interface member.

[0080] According to at least one embodiment, different electronic signals are associated with different operating states of the drug delivery device. For example, each electronic signal is associated with a different operating state of the drug delivery device. The different electronic signals can be used to initiate different operating states of the drug delivery device, for example by using a control unit of the user interface member.

[0081] According to at least one embodiment, different lighting patterns are assigned to different operating states, for example the drug delivery device or the user interface member is configured such that the assigned lighting pattern is automatically generated when initiating an operating state, thereby providing the user with information about which operating state he or she has initiated.

[0082] In at least one embodiment, the user interface member is configured to be manually manipulated by a user to initiate different operational states of the drug delivery device, and configured to generate different electronic signals depending on how the user interface member is manipulated, the different electronic signals being associated with different operational states of the drug delivery device, the different operational states being assigned different lighting patterns.

[0083] According to at least one embodiment, manual manipulation of a user interface member includes at least one of touching, pressing, and rotating. The user interface member may include one or more sensors for detecting manual manipulation, such as a touch sensor, an acceleration sensor, an IR sensor, etc.

[0084] Next, a method of operation of the user interface members will be described in detail. The user interface members for the method of operation may be any of the user interface members described in detail above. Thus, all features disclosed for the user interface members are also specified for the method of operation and vice versa.

[0085] In at least one embodiment, a method of operating a user interface member comprises the steps of: - generating an electronic or electrical signal in response to a manner in which a user manually manipulates a user interface member, the electronic signal being associated with an operational state of the drug delivery device; - operating at least one light emitting element in response to the operational state and / or the electronic signal to present a lighting pattern to a user via a lighting area assigned to the operational state. Includes.

[0086] An electronic signal may also be used to initiate an operating state.

[0087] Next, the drug delivery device will be described in detail. The drug delivery device may be an injection device and / or a pen-type device, such as a dial-extension pen. The drug delivery device may be a variable dose device that allows the drug dose delivered to the user to be variably set. For example, the drug delivery device is a reusable device.

[0088] According to at least one embodiment, the drug delivery device includes a user interface member, which may in particular be a user interface member as detailed herein, and therefore all features disclosed for the user interface member are also disclosed for the drug delivery device and vice versa.

[0089] According to at least one embodiment, the drug delivery device includes a container holder for holding the drug container. The container holder may be the housing of the drug delivery device or may be connected or connectable to the housing. The container holder may be configured to hold the drug container axially and / or rotationally fixed relative to the housing of the drug delivery device. In particular, the container holder may hold the drug container such that the drug container does not move axially and / or rotationally during the drug delivery process.

[0090] According to at least one embodiment, the drug delivery device includes a drug container filled with a drug. The drug container can be a syringe with a needle pre-attached to its distal end. Alternatively, the needle can be attachable to the drug container, for example, at its distal end.

[0091] A method of operating the drug delivery device may be as follows: the user dials the dose to be injected to the user, for example by touching or holding the user interface member at a lateral surface and rotating it. The user interface member may be rotated in a helical path relative to the housing and / or the drug container (holder), thereby moving, for example, in a proximal direction. After dialing the desired dose, the user interface member may be pushed axially, for example in a distal direction, and the dose of drug is injected. For this purpose, the user may press the proximal surface of the user interface member. Before or after dialing the dose and injecting the dose, the user may manipulate the user interface member in a first way, for example pushing in a distal direction for a first period of time, to initiate a first operating state, for example advertising for pairing with a further device, such as to establish a Bluetooth connection / pairing. This first operating state may be indicated to the user by generating a lighting pattern assigned to the first operating state. Additionally or alternatively, the user may manipulate the user interface member in a second manner, e.g., pushing it distally for a second period of time, to attempt or initiate a second operational state, e.g., data synchronization of the drug delivery device with a further device, e.g., synchronization of dosage information. The second operational state may be indicated to the user by generating a further lighting pattern assigned to the second operational state.

[0092] Operating the user interface member in the first and / or second manner may be performed without dialing in a drug dose and / or injecting a dose before or after, i.e., the first and second manners of operating the user interface member may be used in an initial or zero dose setting position.

[0093] The features described for the user interface members, drug delivery devices and methods may be combined with each other, even if such combination is not explicitly disclosed herein, e.g., a feature relating to a user interface member or a drug delivery device also applies to the method and vice versa.

[0094] In the following, the user interface member, the drug delivery device and the method of operation of the user interface member described herein will be explained in more detail based on exemplary embodiments with reference to the drawings. The same reference numbers indicate the same elements in the individual figures. However, the relevant size ratios are not necessarily to scale and the individual elements may rather be illustrated with exaggerated size for better understanding. [Brief description of the drawings]

[0095] [Figure 1] 1 illustrates an exemplary embodiment of a drug delivery device in an exploded view. [Diagram 2] 1 illustrates a proximal section of an exemplary embodiment of a drug delivery device in different operating states. [Diagram 3] 1 illustrates a proximal section of an exemplary embodiment of a drug delivery device in different operating states. [Figure 4] 1A-1D show different views of the proximal section of an exemplary embodiment of a drug delivery device. [Diagram 5] 1A-1D show different views of the proximal section of an exemplary embodiment of a drug delivery device. [Figure 6] 4 illustrates an exemplary embodiment of different illumination patterns. [Figure 7] 4 illustrates an exemplary embodiment of different illumination patterns. [Figure 8] 4 illustrates an exemplary embodiment of different illumination patterns. [Figure 9] 1 illustrates an embodiment of a user interface member based on a cross-sectional view. [Figure 10A] 13 illustrates another embodiment of a light distributing element. [Figure 10B] 13 illustrates another embodiment of a light distributing element. [Figure 10C] 13 illustrates another embodiment of a light distributing element. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0096] In the following, exemplary embodiments are described with respect to an insulin injection device, however, the present disclosure is not limited to such application and can be equally deployed with injection devices configured to deliver other medicaments or drug delivery devices in general, preferably pen-type devices and / or injection devices.

[0097] Some exemplary embodiments herein are described with respect to a drug delivery device in the form of an injection device in which the user interface member is formed as a knob that simultaneously realizes an injection button and a dose setting (dial setting) member, similar to the devices disclosed, for example, in WO 2014 / 033195 A1 or WO 2014 / 033197 A1. The knob can thus be used to initiate and / or execute a dose delivery operation of the drug delivery device and can also be used to initiate and / or execute a dose setting operation. The device can be of the dial extension type, i.e. during dose setting the length of the device increases. Other injection devices having the same kinematic behavior of dial extension during dose setting and dose ejection operating modes are known, for example, as the Kwikpen® or Savvio® devices sold by Eli Lilly, and the FlexPen®, FlexTouch® or Novopen® devices sold by Novo Nordisk. The application of the general principles to these devices is therefore clearly straightforward and will not be further described. However, the general principles of this disclosure are not limited to that kinematic behavior.

[0098] Some other embodiments can be envisaged for application to injection devices with separate injection button and gripping component / dose setting member, such as the device disclosed in WO 2004 / 078239 A1. The present disclosure therefore also relates to a system having two separate user interface members, for example one for the dose setting operation and one for the dose delivery operation. To switch between the dose setting and dose delivery configurations of the device, the user interface member for dose delivery can be moved relative to the user interface member for dose setting.

[0099] If one user interface member is provided, it can be moved distally relative to the housing. In the course of each movement, a clutch between the two members of the dose setting and the drive mechanism of the device changes its state, for example from engaged to disengaged or vice versa. For example, a clutch formed by a set of interlocking teeth on the two members can lock the two members against rotation with respect to each other when engaged, and when the clutch is disengaged or released, one of the two members can rotate relative to the other of the two members. One of the members can be a drive member or drive sleeve that engages with the piston rod of the dose setting and drive mechanism. The drive sleeve can be designed to rotate relative to the housing during dose setting and can be locked against rotation with respect to the housing during dose delivery. The engagement between the drive sleeve and the piston rod can be a threaded engagement. Thus, during dose delivery, the drive sleeve cannot rotate, so that an axial movement of the drive sleeve relative to the housing rotates the piston rod. This rotation can be translated into an axial displacement of the piston rod during the delivery movement due to the threaded connection between the piston rod and the housing.

[0100] 1 is an exploded view of an exemplary embodiment of a drug delivery device 100. In this exemplary embodiment, the drug delivery device 100 is an injection device, such as a pen-type injector.

[0101] The injection device 100 of FIG. 1 is an injection pen including a housing 10 for holding a drug container 14, e.g. an insulin container or a container holder for such a container 14. The container 14 may contain a medication, e.g. insulin. The container 14 may be a cartridge or a receptacle for a cartridge, which may be configured to contain or receive a cartridge. A needle 15 may be attached to the container 14 or receptacle. The container 14 may be a cartridge and the receptacle may be a cartridge holder. The needle 15 is protected by an inner needle cap 16 and either an outer needle cap 17 or another cap 18. The insulin dose to be expelled from the injection device 100 may be set, programmed or "dialed" by turning a user interface member 1 in the form of a knob 1, and the currently programmed or set dose is then displayed via a dosage window 13, e.g. in multiples of units. The units can be determined by a dose setting mechanism that can only allow rotation of the knob 1 relative to the housing 10 in integer multiples of one unit setting increments that can define a single dose increment. This can be achieved, for example, by a suitable ratchet system. The markings displayed in the window can be provided on the number sleeve or on the dial sleeve 70. For example, if the injection device 100 is configured to administer human insulin, the dose can be displayed in so-called international units (IU), where 1 IU is bioequivalent to approximately 45.5 micrograms (1 / 22 mg) of pure crystalline insulin. In injection devices for delivering analog insulin or other medications, other units can be employed. It is noted that the selected dose can likewise be displayed differently than that shown in the dose window 13 of FIG. 1.

[0102] The dose window 13 may be in the form of an aperture in the housing 10 that allows the user to view a limited portion of the dial sleeve 70 that is configured to move when the knob 1 is turned to provide a visual indication of the currently programmed dose. The knob 1 rotates in a helical path relative to the housing 10 as it is turned during programming.

[0103] In this exemplary embodiment, the knob 1 includes one or more features 71a, 71b, 71c in the form of structures that facilitate grasping and / or attachment of a data collection device or electronic system.

[0104] The injection device 100 may be configured to provide audible feedback to the user by generating a mechanical click sound when the knob 1 is turned. In this embodiment, the knob 1 also acts as an injection button. When the needle 15 is inserted into the patient's skin portion and the knob 1 is then pressed axially, the insulin dose displayed in the display window 13 is expelled from the injection device 100. After the knob 1 is sufficiently pressed, the needle 15 of the injection device 100 remains in the skin portion for a certain period of time, and the dose is injected into the patient's body. The expulsion of the insulin dose may also generate a mechanical click sound, which is different from the sound generated when the knob 1 is rotated during the dialing of the dose.

[0105] In this exemplary embodiment, during delivery of the insulin dose, knob 1 is returned to its initial position with an axial movement without rotation, while dial sleeve 70 or number sleeve 70 is rotated back to its initial position, for example to indicate a dose of zero units. As already mentioned, the present disclosure is not limited to insulin, but should encompass all drugs in drug container 14, particularly liquid drugs or drug formulations.

[0106] The injection device 100 can be used for several injection processes until the insulin container 14 is empty or the expiration date of the medication within the injection device 100 is reached (eg, 28 days after first use).

[0107] Furthermore, before using the injection device 100 for the first time, it may be necessary to perform a so-called "priming shot" to ensure correct fluid flow from the insulin container 14 and needle 15, for example by selecting 2 units of insulin and pressing knob 1 while holding the injection device 1 with the needle 15 up. For ease of presentation, in the following it is assumed that the expelled amount corresponds substantially to the injected dose, e.g. such that the amount of drug expelled from the injection device 100 is equal to the amount received by the user.

[0108] As explained above, the knob 1 also functions as an injection button, so that the same component is used for dialing / setting the dose and dispensing / delivering the dose. It should be noted that here too, a configuration with two different user interface members that are movable relative to each other, preferably only in a limited way, is also possible. However, the following discussion focuses on a single user interface member that provides dose setting and dose delivery functions. In other words, the setting surface of the member that the user touches for the dose setting operation and the dose delivery surface that the user touches for the dose delivery operation are immovably connected. Instead, if different user interface members are used, they may be movable relative to each other. During the respective operations, the user interface member is preferably moved relative to the body or housing of the device. During dose setting, the user interface member is moved proximally and / or rotated relative to the housing. During dose delivery, the user interface member is preferably moved axially, e.g. distally, without rotating relative to the housing or body.

[0109] 1 also shows the coordinate system used herein to specify the location of parts or elements or functions. The distal direction D and the proximal direction P run parallel to the longitudinal axis L. The longitudinal axis L is the main axis of elongation of the device 100. The radial direction R is perpendicular to and intersecting the longitudinal axis L. The azimuthal direction C, also called the angular or rotational direction, is perpendicular to the radial direction R and to the longitudinal axis L. In the following figures, in order to increase the clarity of the figures, the different directions and axes are not shown in all of the figures.

[0110] 2 shows the proximal section of the drug delivery device 100. The knob 1 has a luminous area 2 which comprises two partial areas 23, 24. The luminous area 2 forms a transition area, in particular an edge, between the lateral surface formed by the grip element 12 and the proximal surface formed by the cover element 11. The luminous area 2 is formed, for example, from a transparent material, for example a transparent plastic. The grip element 12 and the cover element 1 may each be formed from an opaque material, for example a colored plastic.

[0111] 2 shows the drug delivery device 100 in a first operating state, e.g. attempting to establish (Bluetooth) pairing with a further device such as a smartphone, a smartwatch or a computer. The first operating state is visualized to the user by an illumination pattern comprising alternating emissions from the two part regions 23 and 24.

[0112] 3 shows the drug delivery device 100 in a second operating state, e.g. when the drug delivery device 100 synchronizes data with a further device, e.g. a computer or a smartphone. This second operating state is indicated by an illumination pattern in which the two part areas 23, 24 emit light simultaneously in a blinking mode, the illumination being switched on and off repeatedly.

[0113] The knob 1 can also be configured to initiate two different operating states. For example, the knob 1 can be configured such that pressing the knob 1 in the distal direction D for at least 0.5 seconds, but less than 3 seconds, initiates the second operating state. Pressing the knob 1 in the distal direction D for at least 3 seconds, but less than 20 seconds, can initiate the first operating state. The lighting patterns assigned to the operating states can be presented immediately after the respective operating state is initiated, for example up to 100 ms after initiation.

[0114] Further, pressing knob 1 distally for more than 20 seconds or less than 0.5 seconds can initiate a further operating state in which knob 1 or drug delivery device 100, respectively, is shut down to conserve energy. For example, in a third operating state, one or more electronic elements of the drug delivery device are powered off or interrupted.

[0115] Whether or not the knob 1 is pressed and / or the time for which it is pressed or touched can be determined via a sensor or a switch. When pressed, the knob can be moved relative to, for example towards, the housing. This can trigger a switch, for example by establishing a conductive connection, or a sensor can detect that the knob is being touched or pressed. The signal of the sensor or switch can be evaluated by a control unit (not shown in FIG. 4, for example a microprocessor) of the device. If it is found that the manipulation of the knob fulfills the condition of one of the (predefined) operating states that should trigger an illumination (pattern), the control unit can issue a command to the light-emitting elements or LEDs 3, 4 to operate according to the pattern. The control unit and the LEDs can be mounted on the same carrier, for example a PCB.

[0116] The device may include an electronic dose capture system (not shown in FIG. 4) that uses an encoder component and one or more sensors, such as an optical encoder and one or more optical sensors. The dose capture system is configured to monitor and / or quantify relative movement between the encoder component and the sensor, for example, via a signal generated by the sensor in response to the relative movement. This relative movement may indicate the size of the delivered dose. An example of such a dose capture system is disclosed in WO 2019 / 101962 A1, the disclosure of which is specifically, but not limited to, dose capture systems and is incorporated herein by reference.

[0117] The condition for one of the operating states to trigger the illumination (pattern) may include a certain duration that the knob is pressed (see further times above). For example, a first and a second operating state may be indicated by illumination, with the first operation (e.g. (Bluetooth) pairing or advertising) requiring the knob to be pressed longer than the second operation (e.g. (dose data) synchronization). Another condition (in addition to or instead of the conditions mentioned above) may be whether the dose capture system generates a signal within a certain time, e.g. 0.5 seconds, after the button is pressed, for example. If a signal is detected within the certain time, no illumination may occur (e.g. because it is assumed that the user has covered the knob with their finger for a longer time and / or that the needle has already pierced the user's skin and therefore does not require any further indication). The illumination (pattern) may only be provided if the knob is in its initial or zero dose setting position (if the dose capture system does not generate a signal in response to the knob being pressed, the knob is likely in that position).

[0118] 4 shows the proximal section of the drug delivery device 100 with the cover element 11 removed from the knob 1. The knob 1 comprises a light-distributing element 5. The light-distributing element 5 is made in one piece from a transparent material, for example a transparent plastic. The light-distributing element 5 is disk-shaped with a main extension plane extending perpendicularly to the longitudinal axis L. The light-distributing element 5 comprises two subsections 53, 54 that are assigned to different partial regions 23, 24 of the light-emitting area 2. The two subsections 53, 54 are optically separated from each other by the structure of the light-distributing element 5.

[0119] A recess 50 in the form of a hole is formed in the light distributing element 5. Inside the recess or hole 50 two radiation emitting elements 3, 4 are arranged. The radiation emitting elements 3, 4 are for example LEDs, in particular so-called sidelookers.

[0120] The knob 1 is configured to operate the LEDs 3, 4 depending on the operating state of the drug delivery device 100. The light emitted from the LEDs 3, 4 is coupled into a light-input side 51 of the light-distributing element 5, said light-input side 51 or its surface extending perpendicularly to the main extension plane of the light-distributing element 5. In the present case, the LEDs 3, 4 emit light in opposite radial directions. The light-distributing element 5 may include two faces (light-input faces) where the light enters the light-distributing element. These faces may be parallel and / or facing each other. These faces may be parallel to the longitudinal axis L and / or may laterally define a part of a recess or hole 50.

[0121] Light entering the light distribution element 5 via the light entrance side 51 is guided to the light exit side 52 of the light distribution element 5. The light exit side 52 forms the light-emitting area 2. The light exit side 52 is a surface of the light distribution element 5 that extends obliquely with respect to the longitudinal axis L and with respect to the lateral surface of the gripping element 12. The light emitted via the light-emitting area 2 is therefore directed not only in the radial direction but also in the proximal direction P. The light-emitting area 2 or the light exit side 52, respectively, is ring-shaped.

[0122] FIG. 5 shows the drug delivery device 100 of FIG. 4, but now with a cover element 11 attached. The cover element 11 forms the proximal face of the knob 1. The light output side also extends obliquely to the proximal face formed by the cover element 11. The light distribution element and the cover element can be twin shot molded together to form one component. This component can be clipped onto the user interface member or its body. Other manufacturing methods are possible, for example as mentioned in the overview section.

[0123] Figures 6 to 8 show different lighting patterns that can be achieved by knob 1. In particular, the figures show different blinking patterns of LEDs 3, 4, respectively. Each pattern can indicate a particular operating state.

[0124] In Fig. 6, LEDs 3, 4 are operated simultaneously or synchronized in blinking mode so that the LEDs are activated at the same time. This may indicate that the device is advertising to perform and / or is performing a synchronization process (of dose data). In Fig. 7, LEDs 3, 4 are operated in blinking mode, respectively, but alternately, so that when LED 3 is activated (emits light) LED 4 is off (does not emit light) and when LED 4 is activated LED 3 is off. The period during which LEDs 3, 4 are activated may be 100 ms, and the frequency at which LEDs 3, 4 are activated may be 1 Hz or 0.5 Hz.

[0125] Figure 8 shows a lighting pattern where both LEDs 3, 4 are operated in blinking mode and alternating. The time window in which LEDs 3, 4 are activated is longer compared to Figure 7. This pattern may indicate that the device is advertising for pairing and / or that the pairing procedure is taking place. Of course, further states may also be indicated, e.g. a dose setting or dose delivery state, an alarm state, etc.

[0126] FIG. 9 shows an embodiment of a drug delivery device for a user interface member or knob 1 or an injection device having this knob or user interface member based on a cross-sectional view. The knob 1 has a body 80. The body 80 can provide an outer side or side of the knob available for manipulation by the user. One or more electric or electronic elements are arranged in the knob. Purely by way of example, a battery or power source 82, e.g. a coin cell; an electronic control unit 84, e.g. a microprocessor or microcontroller or an ASIC (Application Specific Integrated Circuit); one or more sensors 86, e.g. a sensor suitable for measuring the movement between an element of the dose setting and a drive mechanism of the device 100, e.g. a radiation sensor that is sensitive to radiation reflected from a moving element that is coded to cause a change in the radiation reflected to the sensor when there is a relative movement, the sensor 86 can communicate with the electronic control unit; for example, a sensor or switch 88 is shown that detects whether the knob 1 is pressed towards the housing or not, preferably in communication with the electronic control unit.

[0127] The knob 1 may have corresponding elements in the previously discussed embodiment. Other features discussed in the previous embodiment also apply to this embodiment of the user interface member, unless differences are highlighted. For example, in the proximal end region of the knob 1, a light distribution element 5 is shown. This element may be configured as described above or further below. A cover element 11 is also shown. The light distribution element 5 and the cover element 11 close the body 80 proximally and / or are rigidly connected to the body 80, for example fixed by a snap fit. The light distribution element 5 provides a light output side 52. As shown in FIG. 9, the light output side is formed by or includes a surface of the light distribution element 5 that extends obliquely to the longitudinal axis L and / or to the main extension direction or plane of the light distribution element. The main extension direction or plane of the light distribution element may be perpendicular to the longitudinal axis L. The light emitting elements or LEDs 3, 4 are not explicitly shown in this figure. However, they are provided in the region of the recess or hole 50 and / or the light-input side 51 of the light-distributing element.

[0128] One or more conductor carriers 90, e.g., circuit boards such as printed circuit boards (e.g., flexible or rigid-flexible printed circuit boards), may be disposed within the user interface member or knob 1. For example, the light-emitting elements 3, 4 and the electronic control unit 84 may be disposed on the same conductor carrier, which may have flexible regions, thus achieving the configuration shown in Figure 9. Alternatively, the electronic control unit 84 and the light-emitting elements 3, 4 may be disposed on separate carriers 90 that are preferably conductively connected to each other such that the electronic control unit 84 can control the operation of the light-emitting elements 3, 4.

[0129] 10A-10C show an embodiment of a light distributing element 5, for example the one shown in FIG. 9. FIG. 10A shows a top view of the light distributing element 5, in particular its proximal end, which in FIG. 9 is covered by a cover element. The light output side 52, which may be ring-shaped and / or formed by a continuous surface of the light distributing element, has two partial regions 21 and 22. The light input side 51 comprises one or more light input surfaces 91, 92. The surfaces 91, 92 are arranged opposite and / or parallel to each other. Each surface 91, 92 may be parallel to a longitudinal axis L, which in the illustrated situation is perpendicular to the plane of the drawing. To each light input surface 91, 92 one light emitting element 3, 4 can be assigned.

[0130] The light distributing element 5 is configured in such a way that light entering the light distributing element 5 through different light entry faces 91, 92 is guided or directed to different partial regions 21, 22. In particular, in contrast to the light distributing element 5 considered in the previous embodiment, the partial regions 21, 22 of the light-emitting area 2 are not optically separated from one another. That is, if the element 5 is configured to direct light from a light entry face into the associated one partial region (and preferably not into the other partial region), optical crosstalk is in principle possible. Light entering the light distributing element 5 through face 91 is guided into partial region 21, and light entering the light distributing element 5 through face 91 is guided into partial region 22.

[0131] The light distributing element 5 includes or defines one or more light distributing systems 93. Each light inlet surface may have one associated light distributing system 93. The respective light inlet surface 91, 92 may be assigned a light distributing system for a different light inlet surface positionally, but otherwise may be configured similarly when viewed along the light path from the respective light inlet surface 91 or 92 to the associated partial area 21 or 22. The light distributing system 93 is configured to diverge or spread the light or light beam bundle incident through the light inlet surface. The divergence or spread may occur in a plane perpendicular to the longitudinal axis L and / or along the main emission direction of the light emitting element 3, 4 or the main extension plane of the light distributing element. Alternatively or additionally, the light distributing system 93 is configured such that the light is deflected towards the light output side 52, for example by reflection and / or refraction. The deflection allows the light to travel obliquely, for example at an angle of 45°, relative to the parallel and / or opposing main emission direction of the light-emitting elements 3, 4, relative to the main extension plane of the light distribution element and / or relative to the longitudinal axis L.

[0132] 10B and 10C show light distributing system 93 in more detail. FIG. 10B shows a cross-sectional view of light distributing element 5.

[0133] FIG. 10B shows the light spreading or diverging subsystem of the light distribution system 93. Light emitting elements 3, 4 are shown. Each light emitting element 3, 4 is assigned to one of the light entry faces 91, 92. The light distribution system 93 includes a first or primary light distribution feature 94 when viewed from the respective light entry face along the light path. The first light distribution feature 94 can be a recess or a hole in the light distribution element 5. The first light distribution feature 94 defines an air / material interface, where the material is one of the materials of the light distribution element 5. The interface can be used to reflect or refract radiation depending on the angle of incidence on the interface, or to pass the radiation unchanged. The first light distribution feature 94 can be a first feature that affects the light path in the light distribution element 5 after the light enters the light distribution element 5. The light distribution feature 94 has two (inclined) faces 941 and / or tapers towards the light entry face 91 or 92 associated with the light distribution system. The (inclined) faces 941 may be connected to each other, for example by a direct transition area, in the region of the function 94 closest to the light entrance side 91, 92. The inclined faces 941 may be curved, for example convexly curved when the respective faces are viewed from within the function 94. The inclined faces are connected by a further face 942, remote from the light entrance face 51. The face 942 is curved, for example concavely curved when the face 942 is viewed from within the function 94. The radius of curvature may be smaller than the radius of curvature of the light exit side in a plane perpendicular to the longitudinal axis L. The face 942 may comprise or be formed by a segment of a circle centered on the longitudinal axis L. The light distribution feature 94 may have an approximately triangular shape. The light manipulated by the light distribution feature 94 may illuminate the associated partial region 21 or 22, in particular its central part. The feature 94 may allow the passage of light through a recess associated with refraction at the interface or may reflect radiation towards a second or secondary light distribution feature 95, for example by total internal reflection. After passing through the light distributing feature 94 , the light can re-enter the light distributing element 5 and travel further towards the light output side 52 .

[0134] The light distribution system 93 further comprises a secondary or second light distribution feature 95, for example formed by a recess or hole in the element 5 with an associated interface (material / air). The light distribution feature 95 is advantageously arranged to receive the light reflected towards it by the first light distribution feature 94 and can further distribute the light in an angular direction (i.e. diverge or widen the beam). One secondary light distribution feature is associated to each side of the primary or first light distribution feature 94. The light distribution feature 95 can be offset in an angular direction from the light distribution feature 94 and / or overlap radially with the light distribution feature 94, for example the inclined surface 941 of the light distribution feature 94 that is closest to the feature 95. Each of the light distribution features 95 can distribute light to an edge portion of the associated partial area 21 or 22. The central portion illuminable via the feature 94 is arranged between the edge portions illuminable via the light distribution feature 95. Each light distribution feature 95 has two, for example oppositely arranged, faces 951, 952. The faces may be curved differently, for example one concavely curved and one concavely curved. The radius of curvature may vary along face 951 and / or face 952. Face 951 closer to feature 94 and / or the outer edge of light distributing element 5 is concavely curved when looking on face 951 from within feature 95. Face 952 further from feature 94 and / or the outer edge of light distributing element 5 is convexly curved when looking on face 952 from within feature 95.

[0135] Via the light distribution system 93, a partial area of ​​at least 120° angular spread of the light output side 52 is illuminated via one light-emitting element 3 or 4 associated with the light input surface 91 or 92 (i.e. partial area 21 or 22), which illumination can be perceived by the user. The illuminated partial area may have an angular spread of 160° or more or 180° (or more). The illuminated partial area may have an angular spread of 200° or less or 180° or less, for example about 180°. The light distribution element serves to guide the light emitted from different light-emitting elements to the ring-shaped light output side 52 or different parts of the light output side, when viewed along the main extension plane of the light distribution element 5.

[0136] FIG. 10C shows a light deflection subsystem of the light distribution system 93. The light deflection system may be a system that diverges or widens the light when viewed along the light path from the light input side 51 to the light output side 52. That is, the light may be widened or diverged before reaching the light deflection system. The light deflection subsystem includes a light deflection surface 96. The light deflection surface 96 may be constructed and arranged to reflect the light incident thereon and thus direct the light to the light output side 52 where the light may exit the light distribution element. The light deflection surface 96 is oriented obliquely with respect to the longitudinal axis L, the main emission direction of the light-emitting element and / or the main extension plane of the light distribution element 5. The light deflection surface 96 may reflect light by total internal reflection or by a reflective coating applied to the surface externally. Light traveling through the first light distribution feature 93 re-enters the light distribution element 5 and then strikes the light deflection surface 96, where the light may be deflected, for example, by an angle of 90° due to a 45° inclination of the surface 96 (relative to the main emission direction of the light-emitting element and / or the main extension surface of the light distribution element relative to the longitudinal axis L) and exits the light distribution element via the light exit side 52. The light exit side 52 or the associated surface may be elevated relative to the recess 50 and / or the light-emitting element. This further facilitates providing a space bounded by the light distribution element 5 that may receive the closure element 11, which may be opaque as described above. Below the light exit side or surface, a radially oriented surface portion may be provided to form a support surface 97 on which the light distribution element 5 is supported on the body 80 of the user interface member or knob 1.

[0137] The terms "drug" or "medicament" are used interchangeably herein to describe a pharmaceutical formulation containing one or more active pharmaceutical ingredients or pharma- ceutically acceptable salts or solvates thereof, and optionally a pharma- ceutically 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 medicines are used to treat, cure, prevent, or diagnose diseases or otherwise improve physical or mental well-being. Drugs or medicines can be used for a limited duration or periodically for chronic disorders.

[0138] As described below, a drug or agent may 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 with molecular weights of 500 Da or less, polypeptides, peptides and proteins (e.g., hormones, growth factors, antibodies, antibody fragments and enzymes), 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.

[0139] The drug or agent may be contained in a primary package or "drug container" adapted for use in a drug delivery device. The drug container may be, for example, a cartridge, syringe, reservoir, or other rigid 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 be 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 between the two or more components before and / or during administration to the human or animal body. For example, the two chambers may be configured to be in fluid communication with each other (e.g., via a conduit between the two chambers) and to allow mixing of the two components by a user, if desired, prior to administration. Alternatively or additionally, the two chambers may be configured to allow mixing upon administration of the components to the human or animal body.

[0140] The drugs or agents contained in the drug delivery devices described herein can be used for the treatment and / or prevention of many different types of medical disorders. Examples of disorders include, for example, diabetes or complications associated with diabetes, such as diabetic retinopathy, thromboembolic disorders, such as deep vein thromboembolism or pulmonary thromboembolism. Further examples of disorders are acute coronary syndromes (ACS), angina, myocardial infarction, cancer, macular degeneration, inflammation, hay fever, atherosclerosis and / or rheumatoid arthritis. Examples of APIs and drugs are those found in handbooks such as the Rote Liste 2014 (for example, but not limited to, main groups 12 (antidiabetic agents) or 86 (oncology agents)) and the Merck Index 15th Edition.

[0141] Examples of APIs for the treatment and / or prevention of type 1 or type 2 diabetes or complications associated with type 1 or type 2 diabetes include insulin, e.g., human insulin or a human insulin analog or derivative, glucagon-like peptide (GLP-1), a GLP-1 analog or GLP-1 receptor agonist, analog or derivative thereof, a dipeptidyl peptidase-4 (DPP4) inhibitor or a pharma-ceutically acceptable salt or solvate thereof, or any mixture thereof. The terms "analog" and "derivative" as used herein 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 deletion and / or replacement of at least one amino acid residue present in the naturally occurring peptide and / or by addition of at least one amino acid residue. The added and / or replaced amino acid residue may be either a codable amino acid residue or other 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 the structure of a naturally occurring peptide, such as the molecular structure of human insulin with one or more organic substituents (e.g., fatty acids) attached to one or more of the amino acids. Optionally, one or more amino acids present in the naturally occurring peptide are deleted and / or replaced by other amino acids, including non-codeable amino acids, or amino acids, including non-codeable ones, are added to the naturally occurring peptide.

[0142] 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 the Lys in position B29 can be replaced by Pro; Ala(B26) human insulin; Des(B28-B30) human insulin; Des(B27) human insulin and Des(B30) human insulin.

[0143] Examples of insulin derivatives are e.g. 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-myristoyl LysB28ProB29 human insulin; B28-N-palmitoyl-LysB28ProB29 human insulin; B30-N-myristoyl-ThrB29LysB30 human insulin. ; B30-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.

[0144] 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 flatfish), liraglutide (Victoza®), semaglutide, taspoglutide, albiglutide (Syncria®), dulaglutide (Trulicity®), rExendin-4, CJC-1134-PC, PB-1023, TTP-054, langrenatide / HM-112 60C (Efpeglenatide), 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, MAR7 09, ZP-2929, ZP-3022, ZP-DI-70, TT-401 (pegapamoditide), BHM-034, MOD-6030, CAM-2036, DA-15864, ARI-2651, ARI-2255, tirzepatide (LY3298176), bamadutide (SAR425899), exenatide-XTEN and glucagon-Xten.

[0145] An example of an oligonucleotide is, for example, the cholesterol-lowering antisense therapeutic mipomersen sodium (Kynamro®) for the treatment of familial hypercholesterolemia or RG012 for the treatment of Alport Syndrome.

[0146] Examples of DPP4 inhibitors are linagliptin, vildagliptin, sitagliptin, denagliptin, saxagliptin, berberine.

[0147] Examples of hormones include pituitary or hypothalamic hormones or regulatory active peptides and their antagonists, such as gonadotropins (follitropin, lutropin, chorion gonadotropin, menotropin), somatropine (somatropin), desmopressin, terlipressin, gonadorelin, triptorelin, leuprorelin, buserelin, nafarelin and goserelin.

[0148] Examples of polysaccharides include glycosaminoglycans, hyaluronic acid, heparin, low molecular weight heparin or very low molecular weight heparin or derivatives thereof or sulfated polysaccharides, such as the above-mentioned polysaccharides in polysulfated form and / or their pharmaceutically acceptable salts.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 G-F20 (Synvisc®), sodium hyaluronate.

[0149] The term "antibody" as used herein refers to an immunoglobulin molecule or an antigen-binding portion thereof. Examples of antigen-binding portions of an immunoglobulin molecule include F(ab) and F(ab')2 fragments that retain the ability to bind to an antigen. The 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, the antibody has effector function and is capable of fixing complement. In some embodiments, the antibody has reduced or no binding ability to Fc receptors. For example, the antibody may be an isotype or subtype, an antibody fragment, or a mutant that does not support binding to Fc receptors, 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 (TBTI) and / or dual variable region antibody-like binding proteins (CODV) with crossover binding region orientation.

[0150] The term "fragment" or "antibody fragment" refers to a polypeptide (e.g., antibody heavy and / or light chain polypeptide) derived from an antibody polypeptide molecule 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 an antigen. An antibody fragment may include truncated portions of a full-length antibody polypeptide, but 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.

[0151] The term "complementarity determining region" or "CDR" refers to short polypeptide sequences in 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 in the variable regions of both heavy and light chain polypeptides that are not CDR sequences and that are primarily responsible for maintaining the proper arrangement of the CDR sequences to allow antigen binding. Although the framework region itself typically does not directly participate in antigen binding, as is known in the art, certain residues in the framework region of a particular antibody may be directly involved in antigen binding or may affect the ability of one or more amino acids in the CDR to interact with the antigen.

[0152] 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).

[0153] Pharmaceutically acceptable salts of any of the APIs described herein are contemplated for use in the drug or medicament in the drug delivery device. Pharmaceutically acceptable salts include, for example, acid addition salts and base salts.

[0154] Those of skill in the art will appreciate that modifications (additions and / or removals) of the 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, which encompasses such modifications and all equivalents thereof.

[0155] Exemplary drug delivery devices may include needle-based injection systems as described in Table 1 of Chapter 5.2 of ISO11608-1:2014(E). As described in ISO11608-1:2014(E), needle-based injection systems can be broadly distinguished into multi-dose container systems and single-dose container systems (with partial or complete ejection). The container may be an exchangeable container or an integrated non-exchangeable container.

[0156] As further described in ISO11608-1:2014(E), a multi-dose container system may include a needle-based injection device with an exchangeable container. In such a system, each container holds multiple doses and the dose 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-exchangeable container. In such a system, each container holds multiple doses and the dose size may be fixed or variable (pre-set by the user).

[0157] As further described in ISO11608-1:2014(E), the single-dose container system may include a needle-based injection device with a replaceable container. In one example for such a system, each container holds a single dose, thereby discharging the entire deliverable volume (full discharge). In a further example, each container holds a single dose, thereby discharging a portion of the deliverable volume (partial discharge). Also as described in ISO11608-1:2014(E), the single-dose container system may include a needle-based injection device with an integrated non-replaceable container. In one example for such a system, each container holds a single dose, thereby discharging the entire deliverable volume (full discharge). In a further example, each container holds a single dose, thereby discharging a portion of the deliverable volume (partial discharge).

[0158] The invention described herein is not limited by the description in relation to the exemplary embodiments, but on the contrary, the invention includes any novel feature and any combination of features, in particular any combination of features in the claims, even if said feature or said combination is not itself explicitly recited in the claims or in the exemplary embodiments. [Explanation of symbols]

[0159] 1 User interface components / buttons / knobs 2. Light-emitting area 3, 4 Light emitting element / LED 5 Light distribution element 10 Drug container holder / housing 11 Cover Elements 12 Gripping elements 13 Dosage window 14 Drug containers 15 needles 16 Inner needle cap 17 Outer needle cap 18 Cap 21 Partial region of light-emitting region 2 22 Partial area of ​​light-emitting area 2 50 Recess 51 Light receiving side 52 Idemitsu side 53 Light Distribution Element Subsection 54 Light Distribution Element Subsection 70 Dial Sleeve 71a...71c Functions 80 Main unit 82 Power supply 84 Electronic Control Unit 86 Sensors 88 Switch 90 Career 91 Light entrance surface 92 Light entrance surface 93 Light Distribution System 94 First light distribution function 941 sides 942 sides 95 Second light distribution function 951 sides 952 sides 96 Light deflection surface 97 Support surface 100 Drug delivery device D Distal direction P Proximal direction L Longitudinal axis R Radial direction C Azimuth direction / Rotation direction / Angle direction

Claims

1. A user interface member (1) for a drug delivery device (100), comprising: a light-emitting area (2) configured to be illuminated by at least two light-emitting elements (3, 4) to emit light from said light-emitting area (2) and to visually indicate to a user the operating status of said drug delivery device (100); Including, - the light-emitting area (2) comprises two or more partial areas (23, 24) which can be illuminated independently of one another by the at least two light-emitting elements (3, 4) in order to present different lighting patterns to the user via the light-emitting area (2); - a user interface member (1), wherein the different lighting patterns indicate to the user different operating states of the drug delivery device (100).

2. - comprising said at least two light emitting elements (3, 4), - A user interface member (1) as described in claim 1, configured to operate the at least two light-emitting elements (3, 4) depending on the operating state of the drug delivery device (100) in order to present different lighting patterns to a user via the light-emitting area (2).

3. - comprising two or more light emitting elements (3, 4), - said light emitting elements (3, 4) emit light of the same color; A user interface member (1) according to claim 1 or 2, wherein each light emitting element (3, 4) is assigned to one partial area (23, 24).

4. The different illumination patterns include: a first lighting pattern in which light is emitted simultaneously from at least two different partial areas (21, 22) in continuous or flashing mode over a predetermined time period; a second illumination pattern in which light is emitted alternately from at least two different partial areas (23, 24) over a given period of time; a third, in which light is emitted from one partial area (23) in continuous or flashing mode for a predetermined time, while another partial area (24) does not emit light during said predetermined time; lighting patterns, a fourth lighting pattern in which light of different intensities is emitted from the different partial areas (23, 24) over a given time period; A user interface member (1) according to any one of claims 1 to 3, comprising one or more of:

5. - has a cylindrical shape, - said light emitting area (2) extends circumferentially on the outer surface of said user interface element (1); - said light-emitting area (2) has a linear shape, A user interface member (1) according to any one of claims 1 to 4, wherein the light emitting area (2) is formed at the proximal end of the user interface member (1).

6. the light-emitting area (2) is ring-shaped, and / or The user interface member (1) comprises: a light distribution element (5) configured to receive light from said at least two light-emitting elements (3, 4) on a light-input side (51) and to transmit said light to a light-output side (52) assigned to said light-emitting area (2); A user interface member (1) according to any one of claims 1 to 5, further comprising:

7. A user interface member (1) according to claim 6, wherein the light exit side (52) is formed by a surface of the light distribution element (5) that extends obliquely relative to the main plane of extension of the light distribution element (5).

8. the light distribution element (5) has at least two subsections (53, 54), each subsection (53, 54) being assigned to one partial area (23, 24) of the light-emitting area (2); A user interface member (1) according to claim 6 or 7, wherein the two subsections (53, 54) are optically separated.

9. a recess (50) is formed in said light distribution element (5), - said recess (50) is a hole, - said recess (50) is adapted to receive said at least two light emitting elements (3, 4); A user interface member (1) according to any one of claims 6 to 8, wherein the light entrance side (51) adjoins the recess (50).

10. A user interface member (1) according to any one of claims 6 to 9, wherein the light distribution element (5) is configured to guide light from the light entrance side (51) to the light exit side (52) by reflection and / or refraction.

11. A user interface member (1) according to any one of claims 1 to 10, which is a knob configured to be rotated and / or moved axially relative to the housing (10) of the drug delivery device (100) when operated by a user.

12. - manually operated by a user to initiate different operating states of said drug delivery device (100); - generating different electronic signals depending on how the user interface member (1) is operated It is configured as follows: - said different electronic signals are associated with different operating states of said drug delivery device (100); - the different operating states are assigned to the different lighting patterns, A user interface member (1) according to any one of claims 1 to 11, wherein manual manipulation comprises touching the user interface member, pressing it and / or rotating it.

13. A drug delivery device (100), comprising: a user interface element (1) according to any one of claims 1 to 12, and a container holder (10) for holding a medication container (20); A drug delivery device (100) comprising:

14. - a drug container filled with a drug (14) The drug delivery device (100) of claim 13, further comprising:

15. 15. The drug delivery device (100) of claim 13 or 14, which is an injection device, for example a pen-type injector.

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