Patent Application
20210077741
The present disclosure relates in one aspect to injection device, such as a pen-type injector for setting and dispensing of a dose of a medicament. In particular, the disclosure relates to an injection device comprising a preselector configured to preselect or limit a maximum dose that can be a set and dispensed by the injection device. In another aspect the disclosure relates to an add-on device for use with an injection device in order to monitor and/or to control operation of the injection device
Injection devices for setting and dispensing a single or multiple doses of a liquid medicament are as such well-known in the art. Generally, such devices have substantially a similar purpose as that of an ordinary syringe.
Injection devices, in particular pen-type injectors have to meet a number of user-specific requirements. For instance, with patient's suffering chronic diseases, such as diabetes, the patient may be physically infirm and may also have impaired vision. Suitable injection devices especially intended for home medication therefore need to be robust in construction and should be easy to use. Furthermore, manipulation and general handling of the device and its components should be intelligible and easy understandable. Moreover, the dose setting as well as dose dispensing procedure must be easy to operate and has to be unambiguous.
Typically, such devices comprise a housing including a particular cartridge holder, adapted to receive a cartridge at least partially filled with the medicament to be dispensed. Such devices further comprise a drive mechanism, usually having a displaceable piston rod which is adapted to operably engage with a piston of the cartridge. By means of the drive mechanism and its piston rod, the piston of the cartridge is displaceable in a distal direction or dispensing direction and may therefore expel a predefined amount of the medicament via a piercing assembly, which is to be releasably coupled with a distal end section of the housing of the injection device.
The medicament to be dispensed by the injection device is provided and contained in a multi-dose cartridge. Such cartridges typically comprise a vitreous barrel sealed in a distal direction by means of a pierceable seal and being further sealed in proximal direction by the piston. With reusable injection devices an empty cartridge is replaceable by a new one. In contrast, injection devices of disposable type are to be discarded when the medicament in the cartridge has been dispensed or used-up.
For some applications it can be advantageous to limit a maximum size of a dose that can be dispensed or expelled from the cartridge. Then, unintended overdosing of the medicament could be prevented.
It is therefore an object of the present disclosure to provide an injection device with an increased patient safety and which comprises a mechanism that prevents unintended overdosing of a medicament. The injection device should provide a limited capability to set and to dispense doses of different sizes. The injection device should at least temporally provide setting and dispensing of only one or a few differently sized doses. In particular, the injection device should be configured to allow and enable setting and dispensing of only a few, e.g. of two, three or four differently sized doses of the medicament. Moreover, indication or displaying of a size of a dose of appropriate size should be simplified. Indicating or displaying of a size of a dose should be unequivocal, intuitive and straightforward even for patients suffering side effects such as impaired vision.
It is a further aim to provide an add-on device configured for attachment to such an injection device or being configured to be coupled to such an injection device in a data transferring or information transferring way
In one aspect there is provided an injection device for setting and injecting a dose of a medicament. The injection device comprises a housing as well as a dose setting mechanism which is arranged in the housing. The injection device further comprises a dose dial displaceable relative to the housing for setting of a dose. The dose dial may be rotatably supported in or on the housing. It may be rotationally supported at a proximal end section of the housing. The dose dial is user actuatable. Hence, a user may grip and rotate or displace the dose dial relative to the housing for setting or selecting of a dose of variable size. The degree of displacement of the dose dial relative to the housing is indicative to the size of the dose.
Typically, the housing is also sized and configured to accommodate a container filled with the liquid medicament. The container may comprise a cartridge with a tubular shaped barrel and sealed in proximal direction by means of a bung displaceably arranged inside the barrel for expelling the dose of the medicament via a distal end of the barrel. The distal end of the barrel may be sealed by a pierceable seal, such as a septum.
The injection device and/or its dose setting mechanism further comprises a dose tracker. The dose tracker is operably connectable to the dose dial at least during setting of a dose. The dose tracker is at least one of translationally or rotationally displaceable relative to the housing during setting of a dose. A positional state of the dose tracker, i.e. a position and/or an orientation of the dose tracker relative to the housing is indicative of a size of the dose actually set. Hence, in the present context a ‘positional state’ of a component includes a position of the component and an angular orientation of the component relative to another component or relative to the housing. A positional state of the dose tracker reflects for instance at least one or both of the geometric position as well as an angular orientation of the dose tracker relative to the housing of the injection device.
The injection device further comprises a preselector configured to define a maximum dose positional state of the dose tracker relative to the housing. The preselector is configured to vary a maximum dose positional state of the dose tracker. The maximum dose positional state of the dose tracker defines and coincides with a maximum size of a dose that can be set and dispensed with the injection device. By means of the preselector the maximum dose positional state can be changed between at least two states that reflect different maximum dose sizes of the injection device. The preselector may be configured to block a displacement of the dose tracker beyond the maximum dose positional state. Depending on the configuration of the preselector the maximum displacement of the dose dial and hence of the dose tracker for setting of a dose can be varied.
The injection device further comprises at least a first marker provided on one of the dose tracker and the preselector. The first marker is configured to indicate the positional state of the dose tracker relative to the preselector. During dose setting the preselector is typically immobilized relative to the housing. Since the positional state of the dose tracker relative to the housing is indicative of a size of a dose the same is then also valid for the preselector. Before setting of a dose or before conducting a dose setting procedure the preselector is configured to define a maximum dose positional state.
The position or configuration of the preselector is known. Since the preselector is immobile or fixed to the housing at least during setting of a dose by detecting a position or orientation of the first marker on one of the dose tracker and the preselector a positional state of the dose tracker relative to the preselector can be determined. This relative position or orientation of the first marker and hence of the dose tracker relative to the preselector indicates whether the dose tracker has reached the maximum dose positional state or whether the dose tracker has to be displaced further relative to the housing in order to reach the maximum dose positional state.
With at least a first marker a relative position and/or orientation of the dose tracker relative to the preselector can be determined. In this way a conventional display to indicate or to visualize a momentary positional state of the dose tracker and/or of the dose dial can be substituted by the first marker and its ability to distinguish only between two positional states of the dose tracker in relation to the preselector.
The preselector is configured to define one of a plurality of generally possible maximum dose positional states of the dose tracker. The configuration or manipulation of the preselector defines one of a variety of maximum dose positional states. After a definition of one maximum dose positional state on the basis of the preselector the dose dial is user actuatable in order to displace the dose tracker relative to the housing until it reaches the maximum dose positional state.
Dispensing of a dose is only to be conducted when the dose tracker is in the maximum dose positional state. It is therefore sufficient and easily understandable for a user when an indication is given on or with regard to the injection device that either a maximum dose positional state has been reached or not. In case the maximum dose positional state has not yet been reached the user is encouraged to dial the dose dial further until the dose tracker reaches the maximum dose positional state. Upon reaching the maximum dose positional state the injection device is configured to indicate the maximum dose positional state on the basis and by means of the first marker.
The first marker provided on one of the dose tracker and the preselector enables and provides a rather simple, intuitive and easily understandable approach to provide an indicator assembly to visualize a correct setting of a dose of predefined size. A conventional display, e.g. in form of a dosage window in a sidewall of a housing of an injection device, through which window a section of a rotatable number sleeve is visible can be substituted. The complexity of the injection device and of its operation can be therefore reduced.
According to another example the preselector is at least one of translationally or rotationally displaceable relative to the housing between at least two preselection positional states. The preselector is lockable relative to the housing in one of the two preselection positional states. A first preselection positional state may represent and define a first maximum dose positional state. A second preselection positional state of the preselector defines a second maximum dose positional state. The first and the second maximum dose positional states are different.
The preselector is typically only one of translationally or rotationally displaceable relative to the housing. It may comprise a slider being slidably displaceable along a longitudinal axis of the elongated housing. The elongated housing may comprise a tubular or cylindrical shape. It may extend along an axial direction. In the following, the terms axial and longitudinal are used as synonyms. It is also conceivable that the preselector is rotationally displaceable relative to the housing with the longitudinal axis as an axis of rotation. Also, the preselector can be displaced along a sidewall of the housing in a circumferential or tangential direction. Hence, the preselector may comprise a slider being either slidably displaceable relative to the housing along the axial direction and/or along a tangential or circumferential direction.
The preselector is displaceable along a displacement path. The at least two preselection positional states of the preselector are separated along the displacement path. In any of the at least two preselection positional states the preselector is lockable or fixable to the housing. In this way the preselector is stationary and hence fixed to the housing during setting of a dose. After completion of a dose dispensing procedure and if desired the preselector may be displaced to another of the at least two preselection positional states.
With the preselector, the operability and function of the dose dial can be reduced. With the preselector a maximum size of a dose that can be dialed or selected by means of the dose dial can be predefined and hence limited to a given maximum. During setting or selecting of a dose the dose dial can be displaced relative to the housing to displace the preselector to the maximum dose positional state. Since the maximum dose positional state is defined by the preselector it cannot be overruled by the dose dial or dose tracker.
In this way the dose setting procedure is divided into two separate steps. In a first step and by making use of the preselector a maximum dose positional state is defined for the injection device. In a second step thereafter the dose dial is user actuatable to move the dose tracker until it reaches the maximum dose positional state. The separation of the dose setting procedure into these two steps by means of two separate components, namely by the preselector and the dose dial or dose tracker has the benefit that the operability of the injection device in terms of dose setting can be restricted to a limited number of dose sizes.
A caregiver or medical staff may use or configure the preselector to define a maximum dose positional state for the dose tracker. Control of the preselector may be prohibited for the end user or patient. The preselector may be locked in one of the at least two preselection positional states in such a way that the end user or patient is unable to unlock and to modify the preselection positional state of the preselector. In this way the end user or patient is only given the possibility to set a dose by making use of the dose dial, which according to the interaction between the preselector and the dose tracker is only enabled and configured to displace the dose tracker at maximum to the maximum dose positional state. Overdosing can be thus effectively prevented.
Use of the injection device by a patient becomes safer since the injection device is preconfigured for only one predefined dose size. By means of the preselector the injection device originally configured as a variable dose size injection device can be transferred or transformed into a fixed dose injection device preconfigured to set and to dispense numerous doses of a medicament of a predefined size.
On demand and without the necessity to change the injection device a dose size can be modified by reconfiguring the preselector and/or by translationally or rotationally displacing the preselector to a different preselection positional state.
According to another example the injection device comprises an indicator assembly that is configured to indicate when the dose tracker reaches the maximum dose positional state. The indicator assembly is typically configured to visually indicate the coincidence of a momentary state of the dose tracker with the maximum dose positional state. However, the indicator assembly is not limited to visual indicator assemblies. Generally, the indicator assembly may comprise an audible or tactile indicator that produces a sound or that starts to vibrate in response to the dose tracker reaching the maximum dose positional state.
The indicator assembly is typically configured to indicate the relative positional state between the preselector and the dose tracker. If the at least first marker is provided on the dose tracker the indicator assembly or at least a portion thereof is provided on the preselector. In another example, wherein the at least first marker is provided on the preselector the indicator assembly or at least a portion thereof is provided on the dose tracker. The indicator assembly is configured to cooperate or to interact with the at least first marker. One of the dose tracker and the preselector is typically provided with the at least first marker wherein the other one of the dose tracker and the preselector is provided with the indicator or at least a portion thereof. In this way the indicator and that at least first marker are configured to provide an indication representing a relative position of the preselector relative to the dose tracker or vice versa.
In another example the first marker is located on the dose tracker. The indicator assembly is configured to reveal the first marker on the dose tracker when the dose tracker reaches the maximum dose positional state. The dose tracker may comprise a longitudinally extending component of the dose setting mechanism. The dose tracker may comprise a dose sleeve rotatable inside the housing, axially displaceable inside the housing or being threadedly engaged inside the housing. The preselector may comprise a button, a dial or a slider displaceable between the at least two preselection positional states.
The dose tracker and the preselector may be arranged in a radially overlapping way on or inside the housing of the injection device. During setting of a dose the dose tracker is typically displaceable relative to the preselector and relative to the housing of the injection device. Typically, the indicator assembly is located on or is attached to one of the preselector and the housing of the injection device. The housing, the preselector and/or the indicator assembly may cover the first marker that may be provided on an outside surface of the dose tracker as long as the dose tracker has not yet reached the maximum dose positional state. The indicator assembly, the preselector and the dose tracker may be configured to reveal the at least first marker provided on the dose tracker only when the dose tracker reaches the maximum dose positional state. The indicator assembly may be provided by the preselector and/or by the housing of the injection device.
In a further example the indicator assembly is integrated into the preselector. The indicator assembly comprises an aperture extending through the preselector. Here, the preselector may cover at least a portion of the dose tracker. The preselector may also cover at least a portion of a sidewall of the housing of the injection device. The first marker that is provided on an outside surface of the dose tracker is discernible and visible through the aperture of the indicator assembly when the dose tracker reaches the maximum dose positional state.
It is conceivable that the preselector is located in a recess on the sidewall of the housing of the injection device such that a plurality or a major portion of the recess in the sidewall, which recess may be a through opening in the sidewall, is covered by the preselector. Typically, the preselector is displaceable relative to the housing along the displacement path. The dose tracker may be also displaceable at least parallel or in the direction of the elongation of the displacement path of the preselector. In the maximum dose positional state the position of the dose tracker relative to the preselector is always the same irrespective on the position of the preselector relative to the housing. In this way an aperture extending through the preselector and revealing at least a portion on an outside surface of the dose tracker is generally sufficient to indicate whether the dose tracker has reached a maximum dose positional state or not.
The integration of the indicator assembly into the preselector is of particular benefit since there is no need for any further mechanical or electronic components to indicate whether a maximum dose positional state of the dose tracker has been reached or not. The preselector may therefore provide a twofold or double function. On the one hand it is configured to define a maximum dose positional state of the dose tracker. On the other hand the preselector is enabled to visualize whether the dose tracker has reached the predefined maximum dose positional state or not.
In another example the indicator assembly comprises a magnifying lens arranged in the aperture. A magnifying or magnification lens enables an enlarged view of the at least first marker provided on the dose tracker when the at least first marker shows up in the aperture of the preselector. A magnifying lens provides a good, intuitive and easy legibility of the at least first marker.
The at least first marker may comprise any visual symbol, such as a character, a number or a colored area. For instance, the at least first marker may comprise a green colored surface section on the outside surface of the dose tracker. Other portions on the outside surface of the dose tracker, such as a dedicated second surface portion may comprise a different color, such as a red color. As long as a red color shows up in the aperture of the preselector this is an indication to a user, that the maximum dose positional state of the preselector has not yet been reached. The user is hence encouraged to dial the dose dial further in a dose incrementing direction until the green colored first marker shows up in the aperture of the preselector. This would be a clear and unequivocal indication to the end user or patient that the maximum dose positional state has been reached and that the injection procedure, hence dispensing of a dose actually set may commence.
In another embodiment the dose tracker comprises at least one tracking stop feature wherein the preselector comprises at least one preselector stop feature. The preselector stop feature is configured to engage with the at least one tracking stop feature to block and to prevent a displacement of the dose tracker beyond the maximum dose positional state. Insofar the dose tracker and the preselector are mechanically engageable.
The positional state of the preselector, hence the preselection positional state of the preselector relative to the housing provides an end stop and a barrier for the dose tracker travelling in a dose incrementing direction. As soon as the dose tracker mechanically engages with the preselector any further displacement of the dose tracker relative to the housing in a dose increasing direction is effectively blocked. Here, the preselector behaves and acts as a limiter that is configured to limit a dose setting displacement of the dose tracker and hence of the dose dial in a dose incrementing direction relative to the housing.
As soon as the dose tracker reaches the maximum dose positional state its tracking stop feature engages and hence abuts with the preselector stop feature that is at least temporally locked to a predefined longitudinal or axial portion of the sidewall of the housing in accordance to the respective preselection positional state of the preselector. The preselector stop feature and the tracking stop feature may comprise mutually corresponding stop faces, e.g. extending in circumferential and/or radial direction so as to engage axially. Alternatively or additionally the preselector stop feature and the tracking stop feature may comprise mutually corresponding stop faces extending in axial direction and radial direction so as to engage circumferentially.
When configured to engage axially, the mutual engagement of the preselector stop feature and the tracking stop feature provides an axial stop thereby impeding and blocking a longitudinal or axial translation of the dose tracker beyond the maximum axial dose positional state.
When configured to engage circumferentially or tangentially, the mutual engagement of the preselector stop feature and the tracking stop feature provides a rotational stop, thereby impeding and blocking a rotation of the dose tracker relative to the preselector and hence relative to the housing beyond a predefined maximum rotational dose positional state.
The selector stop feature and the limiter stop feature may comprise both, longitudinally and circumferentially extending stop faces configured to mutually engage. In this way a longitudinal as well as a rotational displacement of the dose tracker relative to the housing and hence relative to the preselector can be effectively prevented in a twofold manner. This provides an even improved stop configuration and mechanical abutment for the dose tracker.
In another example the first marker is provided on the dose tracker wherein a second marker is provided on the preselector. In this example the first marker of the dose tracker is subject to a displacement relative to the housing during a dose setting procedure. The second marker which is provided on the preselector is subject to a displacement relative to the housing during a preselection procedure. During dose setting only the dose tracker is moveable relative to the housing while the preselector is stationary relative to the housing. The dose tracker is displaceable relative to the housing until the first marker overlaps, aligns or coincides with the second marker of the preselector. Mutually overlapping, mutually aligning or mutually coinciding first and second markers may be a direct indication to the user or patient that the maximum dose positional state of the preselector has been reached.
The first and the second markers may comprise mutually corresponding symbols or signs, such as mutually corresponding arrows or the like pointers providing a clear and unequivocal appearance when aligning or overlapping mutually thus indicating that the dose tracker has reached the maximum dose positional state.
In another example the indicator assembly is configured to determine the positional state of the dose tracker on the basis of the first marker and wherein the indicator assembly is configured to determine the preselection positional state of the preselector on the basis of the second marker. For this it is not required that the first and the second markers mutually align, overlap or coincide. Rather, the indicator assembly is configured to separately determine the positional state of the first marker and to determine the positional state of the second marker. The acquired positional states of the first and the second markers may be further evaluated or processed by the indicator assembly in order to determine whether the maximum dose positional state has been reached or not.
For this the indicator assembly may comprise at least a first position detector and a second position detector, wherein the first position detector is configured to determine or to measure a positional state of the first marker and wherein the second position detector is configured to determine or to measure a positional state of the second marker. In this way the indicator assembly is configured to separately and independently determine a positional state of the first marker and of the second marker and hence of the dose tracker and the preselector, respectively.
This provides a multitude of geometric variations for the specific implementation of the dose tracker and the preselector. The preselector and the dose tracker do not have to be arranged in an overlapping or partially overlapping configuration. The preselector may be located at a totally different position on or in the housing of the injection device compared to the position of the dose tracker. This allows and enables a universal and variable design of the injection device.
According to another example the indicator assembly is configured to compare the positional state of the dose tracker with the preselection positional state of the preselector. This comparison is typically based on previously acquired or detected positions of the first marker, e.g. provided on the dose tracker and on the position or positional state of the second marker provided on the preselector.
In particular, the indicator assembly may comprise an electronic indicator assembly having at least a processor and a display, preferably an electronic display. The processor may be configured to compare the positional state of the dose tracker as detected by way of of the first marker and on the basis of the first position detector with the preselection positional state of the preselector as detected by the second position detector by way of of the second marker that is provided on the preselector.
First and second position detectors may be provided in or on the housing of the injection device. The first position detector may be configured to determine a positional state of the first marker relative to the housing. Likewise, the second position detector may be configured to determine the positional state of the second marker relative to the housing. The positional states of the first marker and the second marker as detected or measured by first and second position detectors can be mutually compared in order to extract and in order to determine a positional state of the dose tracker relative to the preselector which is indicative of whether the maximum dose positional state of the preselector has been reached or not.
In another example the indicator assembly comprises a processor and an electronic display. The processor and the electronic display are configured to visualize at least one of the positional state of the dose tracker and the preselection positional state of the preselector. Additionally or alternatively, the processor and the electronic display are configured to visualize the positional state of the dose tracker relative to the preselection positional state of the preselector. Since the positional state of the preselector governs and defines the maximum dose positional state of the dose tracker it is generally sufficient to visualize the positional state of the dose tracker relative to the preselection positional state of the preselector.
As long as the dose tracker is not in the maximum dose positional state, the indicator assembly, the processor and the electronic display are configured to provide an indication that the maximum dose positional state has not been reached. As soon and in response to a detection that the dose tracker has reached a positional state relative to the preselector that corresponds to its maximum dose positional state the processor and the electronic display are configured to indicate that the preselector has reached the predefined maximum dose positional state.
Apart from that the processor and the electronic display may also provide information regarding the preselection positional state and the momentary positional state of the dose tracker. In this way, additional information is provided to the user during a dose setting procedure.
According to a further example the indicator assembly comprises a communication unit connected to the processor to exchange electronic data with a remote electronic device. A communication unit is typically implemented as a wireless communication unit. It may be based on conventional radio-frequency wireless transmission standards, such as one of the communication protocols: near field communication NFC, RFID or IEEE 802.11.
The communication unit enables data transmission and data exchange with a remote electronic device. The remote electronic device may comprise or may be provided by a smartphone or some other portable electronic device. In this way, operation of the indicator assembly and data acquired by the indicator assembly can be transmitted to the remote electronic device. In addition, the communication unit may enable and control a reconfiguration of the preselector.
The presently described concept of the injection device is not only limited to purely mechanically operated injection devices, such as mechanically implemented injection pens. The preselector and the injection device may be electromechanically implemented and may be remote controlled by means of the communication module of the indicator assembly.
Here, the remote electronic device may reconfigure the preselector via the communication unit of the indicator assembly. In this way and by means of the communication unit the electronically or electromechanically implemented preselector can be switched to one of the at least two preselection positional states. This provides a further approach to hinder the patient or end user to manipulate the preselector. The reconfiguration of the preselector via the communication unit of the injection device may be password protected or may be encoded. A reconfiguration or manipulation of the electromechanically implemented preselector requires knowledge of a respective electronic authorization or code. Typically, the remote electronic device comprises a software to enable communication with the communication unit in order to reconfigure the preselector and/or the indicator assembly.
The communication unit, the processor and the indicator assembly may be provided as integral components of the injection device that are undetachably connected to the housing of the injection device. In other embodiments a detachable solution is provided, wherein the indicator assembly, the communication unit and/or the processor is provided as a part of an add-on device detachably connectable to the housing of the injection device.
According to a further example the injection device comprises a piston rod and a cartridge. The cartridge comprises a barrel which is filled with a medicament and which is sealed by a bung or a piston. The bung or piston seals a proximal end of the barrel. The bung or the piston is axially displaceable relative to the barrel by means of the piston rod. The piston rod is displaceable in distal direction, hence towards a distal dispensing end of the injection device. An advancing and expelling motion of the piston rod can be induced and controlled by a drive mechanism. The drive mechanism may be configured to drive the piston rod in distal direction in accordance to the positional state of the dose tracker as previously set during a dose setting procedure. During dose dispensing and while the piston rod advances in distal direction the dose tracker returns from a maximum dose positional state to a zero dose positional state.
The injection device may comprise a drive mechanism which is purely mechanically implemented, wherein a driving force for displacing the piston rod in distal direction is exclusively provided by the operator, e.g. by a thumb or a finger of the operator or user of the device. The injection device is not limited to all mechanically implemented injection devices. The injection device may comprise an electric drive or may comprise at least a mechanical energy reservoir providing at least a portion of a dispensing force required for displacing the piston rod in distal direction during expelling of a dose from the cartridge.
According to another aspect an add-on device that is configured for attachment to an injection device is provided. Alternatively, the add-on device may be configured to be coupled to the injection device. The add-on device may be coupled to the injection device for exchanging electronic data. The add-on device is particularly configured for attachment to or for data transferring coupling with an injection device as described above. The add-on device comprises at least a remote indicator assembly that is configured to indicate a positional state of the dose tracker of the injection device relative to the preselector of the injection device. In this way, the injection device may be void of an own indicator assembly. The remote indicator assembly of the add-on device may provide and substitute the indicator assembly as described above in connection with the injection device. This applies when the add-on device is correctly attached to the housing of the injection device or when the add-on device is correctly coupled to the injection device, e.g. in a data transferring way.
The add-on device is particularly configured for use with disposable injection devices that are intended to be discarded after the content of the cartridge has been used or expelled. Typically the add-on device may comprise a fastener to engage with a counter fastener of the housing of the injection device. In this way the add-on device can be positioned at a well-defined location on or at the housing of the injection device. The add-on device may precisely determine a positional state of the dose tracker relative to at least one of the preselector and the housing of the injection device. Additionally or alternatively the add-on device and the remote indicator assembly may determine a positional state of the preselector relative to the dose tracker and/or relative to the housing of the injection device. Swapping and exchanging one injection device by another injection device only requires to detach the add-on device from an initial injection device and to attach the add-on device to the new injection device.
In a further example the remote indicator assembly of the add-on device comprises at least one of a first position sensor and a second position sensor. Here, the first position sensor is particularly configured to determine the positional state of the dose tracker. The second position sensor is particularly configured to determine the preselection positional state of the preselector. Insofar the remote indicator assembly may be configured to separately determine and to separately measure a positional state of the dose tracker and/or a preselection positional state of the preselector independently from each other.
As described above with regard to the electronically implemented indicator assembly also the remote indicator assembly of the add-on device may be configured to compare the positional state of the dose tracker with the preselection positional state of the preselector. The first position sensor may be particularly adapted to identify or to determine the position of the first marker that is provided on the dose tracker. The second position sensor may be likewise configured to determine or to detect a positional state of the second marker that is provided on the preselector.
In general, the remote indicator assembly may be identically shaped and configured compared to the electronically implemented indicator assembly of the injection device. Insofar any features, benefits and advantages described above with regard to the indicator assembly of the injection device are also valid and disclosed for the remote indicator assembly of the add-on device.
Accordingly and in another example of the add-on device the remote indicator assembly comprises a processor and an electronic display. The processor and the electronic display are configured to visualize at least one of the positional state of the dose tracker and the preselection positional state of the preselector. Additionally or alternatively the processor and the electronic display of the remote indicator assembly are configured to visualize the positional state of the dose tracker relative to the preselection positional state of the preselector.
The processor and the electronic display may be configured to visualize the absolute positional states of at least one or both of the dose tracker and the preselector simultaneously or concurrently. It is also conceivable, that the indicator assembly or the remote indicator assembly of the injection device and/or of the add-on device provide an alternating visualization of the actual or momentary positional state of the dose tracker and the preselection positional state of the preselector. The processor and the electronic display may be configured to provide alternative illustrations of the momentary preselection positional state and the actual positional state of the dose tracker. Both indications, e.g. provided in form of numbers or confirmation symbols may be provided next to each other on the electronic display or in an overlapping but temporally alternating way.
The first and second position sensors for determining a positional state of the dose tracker and/or for determining the preselection positional state of the preselector may comprise at least one of electromechanical contact switches, a light detector, such as a photodiode in connection with a light source and/or a transmissive or reflective pattern on the dose tracker and the preselector, respectively, a magnetic sensor in combination with a magnetic encoding on at least one of the dose tracker and the preselector or an electrically conductive structure on at least one of the dose tracker and the preselector.
In the present context the term ‘distal’ or ‘distal end’ relates to an end of the injection device that faces towards an injection site of a person or of an animal. The term ‘proximal’ or ‘proximal end’ relates to an opposite end of the injection device, which is furthest away from an injection site of a person or of an animal.
The term “drug” or “medicament”, as used herein, means a pharmaceutical formulation containing at least one pharmaceutically active compound,
wherein in one embodiment the pharmaceutically active compound has a molecular weight up to 1500 Da and/or is a peptide, a proteine, a polysaccharide, a vaccine, a DNA, a RNA, an enzyme, an antibody or a fragment thereof, a hormone or an oligonucleotide, or a mixture of the above-mentioned pharmaceutically active compound,
wherein in a further embodiment the pharmaceutically active compound is useful for the treatment and/or prophylaxis of diabetes mellitus or complications associated with diabetes mellitus such as diabetic retinopathy, thromboembolism disorders such as deep vein or pulmonary thromboembolism, acute coronary syndrome (ACS), angina, myocardial infarction, cancer, macular degeneration, inflammation, hay fever, atherosclerosis and/or rheumatoid arthritis,
wherein in a further embodiment the pharmaceutically active compound comprises at least one peptide for the treatment and/or prophylaxis of diabetes mellitus or complications associated with diabetes mellitus such as diabetic retinopathy, wherein in a further embodiment the pharmaceutically active compound comprises at least one human insulin or a human insulin analogue or derivative, glucagon-like peptide (GLP-1) or an analogue or derivative thereof, or exendin-3 or exendin-4 or an analogue or derivative of exendin-3 or exendin-4.
Insulin analogues are for example Gly(A21), Arg(B31), Arg(B32) human insulin; Lys(B3), Glu(B29) human insulin; Lys(B28), Pro(B29) human insulin; Asp(B28) human insulin; human insulin, wherein proline in position B28 is replaced by Asp, Lys, Leu, Val or Ala and wherein in position B29 Lys may be replaced by Pro; Ala(B26) human insulin; Des(B28-B30) human insulin; Des(B27) human insulin and Des(B30) human insulin.
Insulin derivates are for example B29-N-myristoyl-des(B30) human insulin; 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-Y-glutamyl)-des(B30) human insulin; B29-N—(N-lithocholyl-Y-glutamyl)-des(B30) human insulin; B29-N-(ω-carboxyheptadecanoyl)-des(B30) human insulin and B29-N-(ω-carboxyheptadecanoyl) human insulin.
Exendin-4 for example means Exendin-4(1-39), a peptide of the sequence H-His-Gly-Glu-Gly-Thr-Phe-Thr-Ser-Asp-Leu-Ser-Lys-Gln-Met-Glu-Glu-Glu-Ala-Val-Arg-Leu-Phe-Ile-Glu-Trp-Leu-Lys-Asn-Gly-Gly-Pro-Ser- Ser-Gly-Ala-Pro-Pro-Pro-Ser-NH2.
Exendin-4 derivatives are for example selected from the following list of compounds:
Hormones are for example hypophysis hormones or hypothalamus hormones or regulatory active peptides and their antagonists as listed in Rote Liste, ed. 2008, Chapter 50, such as Gonadotropine (Follitropin, Lutropin, Choriongonadotropin, Menotropin), Somatropine (Somatropin), Desmopressin, Terlipressin, Gonadorelin, Triptorelin, Leuprorelin, Buserelin, Nafarelin, Goserelin.
A polysaccharide is for example a glucosaminoglycane, a hyaluronic acid, a heparin, a low molecular weight heparin or an ultra low molecular weight heparin or a derivative thereof, or a sulphated, e.g. a poly-sulphated form of the above-mentioned polysaccharides, and/or a pharmaceutically acceptable salt thereof. An example of a pharmaceutically acceptable salt of a poly-sulphated low molecular weight heparin is enoxaparin sodium.
Antibodies are globular plasma proteins (˜150 kDa) that are also known as immunoglobulins which share a basic structure. As they have sugar chains added to amino acid residues, they are glycoproteins. The basic functional unit of each antibody is an immunoglobulin (Ig) monomer (containing only one Ig unit); secreted antibodies can also be dimeric with two Ig units as with IgA, tetrameric with four Ig units like teleost fish IgM, or pentameric with five Ig units, like mammalian IgM.
The Ig monomer is a “Y”-shaped molecule that consists of four polypeptide chains; two identical heavy chains and two identical light chains connected by disulfide bonds between cysteine residues. Each heavy chain is about 440 amino acids long; each light chain is about 220 amino acids long. Heavy and light chains each contain intrachain disulfide bonds which stabilize their folding. Each chain is composed of structural domains called Ig domains. These domains contain about 70-110 amino acids and are classified into different categories (for example, variable or V, and constant or C) according to their size and function. They have a characteristic immunoglobulin fold in which two β sheets create a “sandwich” shape, held together by interactions between conserved cysteines and other charged amino acids.
There are five types of mammalian Ig heavy chain denoted by α, δ, ε, γ, and μ. The type of heavy chain present defines the isotype of antibody; these chains are found in IgA, IgD, IgE, IgG, and IgM antibodies, respectively.
Distinct heavy chains differ in size and composition; α and γ contain approximately 450 amino acids and δ approximately 500 amino acids, while μ and ε have approximately 550 amino acids. Each heavy chain has two regions, the constant region (CH) and the variable region (VH). In one species, the constant region is essentially identical in all antibodies of the same isotype, but differs in antibodies of different isotypes. Heavy chains γ, α and δ have a constant region composed of three tandem Ig domains, and a hinge region for added flexibility; heavy chains μ and ε have a constant region composed of four immunoglobulin domains. The variable region of the heavy chain differs in antibodies produced by different B cells, but is the same for all antibodies produced by a single B cell or B cell clone. The variable region of each heavy chain is approximately 110 amino acids long and is composed of a single Ig domain.
In mammals, there are two types of immunoglobulin light chain denoted by λ and κ. A light chain has two successive domains: one constant domain (CL) and one variable domain (VL). The approximate length of a light chain is 211 to 217 amino acids. Each antibody contains two light chains that are always identical; only one type of light chain, K or A, is present per antibody in mammals.
Although the general structure of all antibodies is very similar, the unique property of a given antibody is determined by the variable (V) regions, as detailed above. More specifically, variable loops, three each the light (VL) and three on the heavy (VH) chain, are responsible for binding to the antigen, i.e. for its antigen specificity. These loops are referred to as the Complementarity Determining Regions (CDRs). Because CDRs from both VH and VL domains contribute to the antigen-binding site, it is the combination of the heavy and the light chains, and not either alone, that determines the final antigen specificity.
An “antibody fragment” contains at least one antigen binding fragment as defined above, and exhibits essentially the same function and specificity as the complete antibody of which the fragment is derived from. Limited proteolytic digestion with papain cleaves the Ig prototype into three fragments. Two identical amino terminal fragments, each containing one entire L chain and about half an H chain, are the antigen binding fragments (Fab). The third fragment, similar in size but containing the carboxyl terminal half of both heavy chains with their interchain disulfide bond, is the crystalizable fragment (Fc). The Fc contains carbohydrates, complement-binding, and FcR-binding sites. Limited pepsin digestion yields a single F(ab′)2 fragment containing both Fab pieces and the hinge region, including the H—H interchain disulfide bond. F(ab′)2 is divalent for antigen binding. The disulfide bond of F(ab′)2 may be cleaved in order to obtain Fab′. Moreover, the variable regions of the heavy and light chains can be fused together to form a single chain variable fragment (scFv).
Pharmaceutically acceptable salts are for example acid addition salts and basic salts. Acid addition salts are e.g. HCl or HBr salts. Basic salts are e.g. salts having a cation selected from alkali or alkaline, e.g. Na+, or K+, or Ca2+, or an ammonium ion N+(R1)(R2)(R3)(R4), wherein R1 to R4 independently of each other mean: hydrogen, an optionally substituted C1-C6-alkyl group, an optionally substituted C2-C6-alkenyl group, an optionally substituted C6-C10-aryl group, or an optionally substituted C6-C10-heteroaryl group. Further examples of pharmaceutically acceptable salts are described in “Remington's Pharmaceutical Sciences” 17. ed. Alfonso R. Gennaro (Ed.), Mark Publishing Company, Easton, Pa., U.S.A., 1985 and in Encyclopedia of Pharmaceutical Technology.
Pharmaceutically acceptable solvates are for example hydrates.
It will be further apparent to those skilled in the art that various modifications and variations can be made to the injection device without departing from the spirit and scope of what is disclosed herein. Further, it is to be noted, that any reference numerals used in the appended claims are not to be construed as limiting the scope of the disclosure.
In the following, embodiments of the drive mechanism and the injection device are described in detail by making reference to the drawings, in which:
The schematic illustration of an injection device 1 in accordance to
The injection device 1 also comprises a dose setting mechanism 9. The dose setting mechanism comprises at least a dose tracker 50. The dose tracker 50 is displaceable relative to the housing 10. It is at least one of translationally or rotationally displaceable relative to the housing 10 during setting of a dose. Typically and during dose dispensing under the action of the drive mechanism 8 the dose tracker 50 returns into a zero dose configuration. In a subsequent dose setting procedure the dose tracker 50 can be become repeatedly subject to at least one of a translational or rotational displacement relative to the housing 10. The displacement of the dose tracker 50 during setting of a dose is controllable or inducible by means of a dose dial 12 that is displaceable relative to the housing 10 for setting of the dose. For instance the dose dial 12 is rotationally supported on a proximal end of the housing 10.
Insofar the illustration of
In addition to the dose tracker 50 the injection device 1 comprises a preselector 70. The preselector 70 is configured to define a maximum dose positional state 55 of the dose tracker relative to the housing 10. The maximum dose positional state 55 is that positional state of the dose tracker 50 that is furthest away from a zero dose positional state of the dose tracker. The maximum dose positional state 55 defines the maximum sized dose of a medicament that can be dispensed with the injection device.
By means of the preselector 70 the maximum dose positional state 55 and hence the maximum dose to be dispensed with the injection device 1 can be varied and modified. Insofar the preselector 70 provides a limiter or is a limiter for the dose setting mechanism 9. The dose setting mechanism 9 and the dose tracker 50 may be originally configured and designed to provide a selection of doses of variable size. With the preselector 70 only one or a few predefined doses among a range of differently sized doses that could be originally dispensed with the injection device 1 are pre-set. Hence, by means of the preselector 70 the capability of the dose setting mechanism 9 to set and to select numerous differently sized doses is reduced to only one or a few differently sized doses of the medicament.
Insofar and by means of the preselector 70 the injection device 1 can be transformed or transferred into a kind of a fixed dose injection device. This is of particular benefit for situations where the user himself should not decide about the size of a dose of the medicament to be administered. From a user perspective the preselector therefore facilitates overall usage and handling of the injection device.
Typically, the preselector 70 and the dose tracker 50 are configured to mechanically engage. The dose tracker 50 may comprise at least one tracking stop feature 51 and the preselector may comprise at least one preselector stop feature 73. By means of the preselector stop feature 73 the preselector 70 mechanically engages with the correspondingly shaped tracking stop feature 51 of the dose tracker 50. In this way a displacement of the dose tracker 50 beyond the maximum dose positional 55 state can be blocked and prevented. The preselector 70 may be only operable by caregivers or medical staff. It may be protected against misuse and may not be operable or actuatable or reconfigurable by the end user or patient. However and according to an individual prescription schedule or medication schedule the care giver may individually modify or configure the preselector 70 so that the injection device becomes capable to dispense and to expel a dose of required size.
The injection device 1 further comprises an indicator assembly 90 by way of which at least a relative position of the dose tracker 50 relative to the preselector 70 can be indicated. Since the device 1 is limited to expel or to dispense only a single sized dose of known size the injection device 1 may be void of a specific dose indicating mechanism, e.g. illustrating the dose size in terms of units of the medicament, such as international units of insulin. It is not required for the indicator assembly 90 to visualize or illustrate a number of units of the medicament actually set. Since the injection device can be limited or restricted to the dispensing or expelling of multiple doses of equal size that particular size is known to at least the caregiver. It is hence sufficient for the patient when the indicator assembly has a limited function and is only capable to provide a comparison between the actual positional state 54 of the dose tracker compared to the predefined maximum dose positional state 55 of the dose tracker 50.
In
In the configuration according to
The illustration of
With the present injection device 1 injection and hence dispensing of the dose should only be triggered and commence when the dose tracker has reached the maximum dose positional state 55.
The preselector 70 is at least one of translationally or rotationally displaceable relative to the housing 10 between the at least two preselection positional states 110, 110′. In any of the available preselection positional states 110, 110′ the preselector is lockable relative to the housing 10. Hence during dose setting the preselector 70 is stationary or fixed to the housing 10 while the dose tracker 50 is subject to at least one of a translational or rotational displacement relative to the housing 10.
The schematic illustration of the injection device 1 directly corresponds to the implementation of an injection device as described later with regard to
In the schematic representation of
Typically, the indicator assembly 190 comprises a first position sensor 430 configured to determine or to detect a positional state of the dose tracker 150. The indicator assembly 190 may comprise a second position sensor 390 configured to determine or to detect a positional state of the preselector 170. Moreover, the electronically implemented indicator assembly 190 may comprise a processor 420 to process signals obtainable from the first position sensor 390 and obtainable from the second position sensor 430.
The processor 420 may be configured to compare the positional state of the dose tracker 150. If the processor 420 determines that the positional state of the dose tracker 150 corresponds to the maximum dose positional state 55 as governed and defined by the momentary preselection positional state 110 of the preselector 70 the processor 420 is configured go provide a respective indicator on an electronic display 410 of the indicator assembly 190. The indicator assembly 190 may further comprise a communication unit 440, e.g. implemented in form of an antenna to receive and/or to transmit electronic data or signals. By means of the communication unit 440 the indicator assembly 190 may exchange data with an external electronic device 500.
The external electronic device 500 may be implemented as a smartphone. The external electronic device may comprise a portable electronic device. It may be provided with a software or a software application that is configured to communicate with the communication unit 440 in a wireless way.
The drive mechanism 8 and the dose setting mechanism 9 as well as the preselector 170 and the dose tracker 150 do not have to be implemented all mechanically. At least one of the drive mechanism 8, the dose setting mechanism 9, the dose tracker 150 and the preselector 170 may be implemented electromechanically. In this way the indicator assembly 190 or its processor 420 can be configured to reconfigure the preselector 170. For instance, the external electronic device 500 may be configured to communicate with the processor 420 via the communication unit 440 to modify the configuration of the preselector 170. When implemented as an electromechanical dose setting mechanism 9 the preselector 170 may be electronically implemented and may be reconfigurable remotely by means of at least one of the electronic device 500 and the processor 420.
In
In
The communication unit 440 may comprise an antenna, such as an RFID antenna. The external electronic device 500 may comprise an RFID reader configured to wirelessly provide and to wirelessly transfer electric energy to the remote indicator assembly 490. Alternative or additional the communication unit 440 may comprise other radio frequency based antennas that may be configured to support one of a WLAN, Wi-Fi or Bluetooth communication protocol. In this way the processor 420 and the electronic display 410 may receive sufficient power for visualizing or for generally indicating the positional state of the dose tracker 150 relative to the preselector 170. The add-on device 400 and/or the remote indicator assembly 490 may also comprise at least one actuation element 450, in form of at least one or several buttons. The actuation element 450 may be also integrated into the electronic display 410. Here, the electronic display 410 may comprise a touch sensitive display.
By means of the actuation element 450 a user may confirm that a dose dispensing operation has just been conducted. Also during dispensing or during dose setting the user may press on the actuation element 450 thus inducing a change of the visual appearance of the electronic display 410. In this way, the electronic display 410 may alternately provide information regarding the preselection positional state and a momentary positional state of the dose tracker.
In the following an example of a handheld and all mechanically implemented injection device 1 is described with regard to
The injection device 1 as shown in
When the injection device 1 is configured to administer e.g. human insulin, the dosage set by a dial 12 at a proximal end of the injection device 1 may be displayed in so-called international units (IU, wherein 1 IU is the biological equivalent of about 45.5 μg of pure crystalline insulin (1/22 mg).
As shown further in
The injection device 1 may be configured so that turning the dosage knob 12 causes a mechanical click sound to provide acoustical feedback to a user. The number sleeve 80 mechanically interacts with a piston in the insulin cartridge 6. When the needle 15 is stuck into a skin portion of a patient, and when the trigger 11 or injection button is pushed, the insulin dose displayed in display window 13 will be ejected from injection device 1. When the needle 15 of the injection device 1 remains for a certain time in the skin portion after the trigger 11 is pushed, a high percentage of the dose is actually injected into the patient's body. Ejection of an insulin dose may also cause a mechanical click sound, which is however different from the sounds produced when using the dial 12.
In this embodiment, during delivery of the insulin dose, the dial 12 is turned to its initial position in an axial movement, that is to say without rotation, while the number sleeve 80 is rotated to return to its initial position, e.g. to display a dose of zero units.
The injection device 1 may be used for several injection processes until either the cartridge 6 is empty or the expiration date of the medicament in the injection device 1 (e.g. 28 days after the first use) is reached.
Furthermore, before using injection device 1 for the first time, it may be necessary to perform a so-called “prime shot” to remove air from the cartridge 6 and the needle 15, for instance by selecting two units of the medicament and pressing trigger 11 while holding the injection device 1 with the needle 15 upwards. For simplicity of presentation, in the following, it will be assumed that the ejected amounts substantially correspond to the injected doses, so that, for instance the amount of medicament ejected from the injection device 1 is equal to the dose received by the user.
The expelling or drive mechanism 8 as illustrated in more detail in
The piston rod 20 is further provided with a second thread 24 at its proximal end. The distal thread 22 and the proximal thread 24 are oppositely handed.
There is further provided a drive sleeve 30 having a hollow interior to receive the piston rod 20. The drive sleeve 30 comprises an inner thread threadedly engaged with the proximal thread 24 of the piston rod 20. Moreover, the drive sleeve 30 comprises an outer threaded section 31 at its distal end. The threaded section 31 is axially confined between a distal flange portion 32 and another flange portion 33 located at a predefined axial distance from the distal flange portion 32. Between the two flange portions 32, 33 there is provided a last dose limiter 35 in form of a semi-circular nut having an internal thread mating the threaded section 31 of the drive sleeve 30.
The last dose limiter 35 further comprises a radial recess or protrusion at its outer circumference to engage with a complementary-shaped recess or protrusion at an inside of the sidewall of the housing 10. In this way the last dose limiter 35 is splined to the housing 10. A rotation of the drive sleeve 30 in a dose incrementing direction 4 or clockwise direction during consecutive dose setting procedures leads to an accumulative axial displacement of the last dose limiter 35 relative to the drive sleeve 30. There is further provided an annular spring 40 that is in axial abutment with a proximally facing surface of the flange portion 33. Moreover, there is provided a tubular-shaped clutch 60. At a first end the clutch 60 is provided with a series of circumferentially directed saw teeth. Towards a second opposite end of the clutch 60 there is located a radially inwardly directed flange.
Furthermore, there is provided a dose dial sleeve also denoted as number sleeve 80. The number sleeve 80 is provided outside of the spring 40 and the clutch 60 and is located radially inward of the housing 10. A helical groove 81 is provided about an outer surface of the number sleeve 80. The housing 10 is provided with the dosage window 13 through which a part of the outer surface of the number 80 can be seen. The housing 10 is further provided with a helical rib at an inside sidewall portion of an insert piece 62, which helical rib is to be seated in the helical groove 81 of the number sleeve 80. The tubular shaped insert piece 62 is inserted into the proximal end of the housing 10. It is rotationally and axially fixed to the housing 10. There are provided first and second stops on the housing 10 to limit a dose setting procedure during which the number sleeve 80 is rotated in a helical motion relative to the housing 10. As will be explained below in greater detail, at least one of the stops is provided by a preselector stop feature 73 provided on a preselector 70.
The dose dial 12 in form of a dose dial grip is disposed about an outer surface of the proximal end of the number sleeve 80. An outer diameter of the dose dial 12 typically corresponds to and matches with the outer diameter of the housing 10. The dose dial 12 is secured to the number 80 to prevent relative movement therebetween. The dose dial 12 is provided with a central opening.
The trigger 11, also denoted as dose button is substantially T-shaped. It is provided at a proximal end of the injection device 10. A stem 64 of the trigger 11 extends through the opening in the dose dial 12, through an inner diameter of extensions of the drive sleeve 30 and into a receiving recess at the proximal end of the piston rod 20. The stem 64 is retained for limited axial movement in the drive sleeve 30 and against rotation with respect thereto. A head of the trigger 11 is generally circular. The trigger side wall or skirt extends from a periphery of the head and is further adapted to be seated in a proximally accessible annular recess of the dose dial 12.
To dial a dose a user rotates the dose dial 12. With the spring 40 also acting as a clicker and the clutch 60 engaged, the drive sleeve 30 the spring or clicker 40, the clutch 60 and the number sleeve 80 rotate with the dose dial 12. Audible and tactile feedback of the dose being dialed is provided by the spring 40 and by the clutch 60. Torque is transmitted through saw teeth between the spring 40 and the clutch 60. The helical groove 81 on the number sleeve 80 and a helical groove in the drive sleeve 30 have the same lead. This allows the number sleeve 80 to extend from the housing 10 and the drive sleeve 30 to climb the piston rod 20 at the same rate. At a limit of travel a radial stop on the number sleeve 80 engages either with a first stop or a second stop provided on the housing 10 provided on the pre-selector 70 to prevent further movement in a dose incrementing direction 4. Rotation of the piston rod 20 is prevented due to the opposing directions of the overall and driven threads on the piston rod 20.
The last dose limiter 35 keyed to the housing 10 is advanced along the threaded section 31 by the rotation of the drive sleeve 30. When a final dose dispensed position is reached, a radial stop formed on a surface of the last dose limiter 35 abuts a radial stop on the flange portion 33 of the drive sleeve 30, preventing both, the last dose limiter 35 and the drive sleeve 30 from rotating further.
Should a user inadvertently dial beyond the desired dosage, the injection device 1, configured as a pen-injector allows the dosage to be dialed down without dispense of the medicament from the cartridge 6. For this the dose dial 12 is simply counter-rotated. This causes the system to act in reverse. A flexible arm of the spring or clicker 40 then acts as a ratchet preventing the spring 40 from rotating. The torque transmitted through the clutch 60 causes the saw teeth to ride over one another to create the clicks corresponding to dialed dose reduction. Typically, the saw teeth are so disposed that a circumferential extent of each saw tooth corresponds to a unit dose.
When the desired dose has been dialed the user may simply dispense the set dose by depressing the trigger 11. This displaces the clutch 60 axially with respect to the number sleeve 80 causing dog teeth thereof to disengage. However, the clutch 60 remains keyed in rotation to the drive sleeve 30. The number sleeve 80 and the dose dial 12 are now free to rotate in accordance with the helical groove 81.
The axial movement deforms the flexible arm of the spring 40 to ensure the saw teeth cannot be overhauled during dispense. This prevents the drive sleeve 30 from rotating with respect to the housing 10 though it is still free to move axially with respect thereto. The deformation is subsequently used to urge the spring 40 and the clutch 60 back along the drive sleeve 30 to restore the connection between the clutch 60 and the number sleeve 80 when the distally directed dispensing pressure is removed from the trigger 11.
The longitudinal axial movement of the drive sleeve 30 causes the piston rod 20 to rotate through the through opening of the support of the housing 10, thereby to advance the bung 7 in the cartridge 6. Once the dialed dose has been dispensed, the number sleeve 80 is prevented from further rotation by contact of at least one stop extending from the dose dial 12 with at least one corresponding stop of the housing 10. A zero dose position may be determined by the abutment of one of axially extending edges or stops of the number sleeve 80 with at least one or several corresponding stops of the housing 10.
The expelling mechanism or drive mechanism 8 as described above is only exemplary for one of a plurality of differently configured drive mechanisms that are generally implementable in a disposable pen-injector. The drive mechanism as described above is explained in more detail e.g. in WO2004/078239A1, WO 2004/078240A1 or WO 2004/078241A1 the entirety of which being incorporated herein by reference.
The injection device 1 further comprises a preselector 70 that is configured to define a maximum dose positional state 55 of the number sleeve 80. Here, the number sleeve 80 represents or substitutes the dose tracker 50 as described above. Although and in view of the indicator assembly 90 the number sleeve is no longer required to illustrate dose indicating numbers in the dosage window 13 of the housing 10. The dose tracker 50 and hence the number sleeve 80 comprises a tracking stop feature 51 to engage with a correspondingly shaped preselector stop feature 73 as will be described in greater detail with regard to
As shown in
The dose tracker 50 comprises a correspondingly shaped tracking stop feature 51. As shown in
The preselector 70 further comprises a slider 72 that is accessible from outside the housing 10. The slider 72 can be integrally formed with the sleeve portion 71. The sleeve portion 71 and the slider 72 may be also provided as separate pieces that are connected together by mutually corresponding connectors, not explicitly illustrated here. The slider 72 is axially guided along a displacement path 49 formed by a recess 41 on an outside facing surface portion of the sidewall 48 of the housing 10. The recess 41 may be circumferentially confined by a surrounding edge 44 forming a stepped down portion in the outside surface of the sidewall 48. The recess 41 comprises a through opening 42 as indicated in
The preselector 70 further comprises a detent structure 76 best shown in
The axial position of the preselector 70 determines a maximum distance the dose tracker 50 can be displaced starting from a zero dose configuration as shown in
The dose tracker 50 and hence the number sleeve 80 comprises a helical groove 81 engaged with a correspondingly shaped protrusion 63 provided at the proximal end of the housing 10. The protrusion 63 may be provided on an inside facing surface portion of the insert 62 fixed to the proximal end of the housing 10. The insert facilitates assembly of the components inside the housing of the injection device.
Also a portion of the bottom section 43 and hence of the recess 41 may be provided by the insert 62. The insert 62 may provide a proximal end cap of the housing 10 of the injection device 1.
The preselector 70 is arrestable or fixable to the sidewall 48 of the housing 10 in at least two different discrete positions denoted as preselection positional states 110, 110′, 110″. The axial distance between neighboring preselection positional states 110, 110′ is identical and corresponds to the longitudinal advancing motion of the dose tracker 50 as the dose tracker 50 undergoes a complete revolution relative to the housing 10. In this way it is guaranteed, that the tracking stop feature 51 always exactly engages with the preselector stop feature 73 when reaching the maximum dose positional state 55.
In the configuration as shown in
In the configuration of
In
The second surface section 84 and hence the second indication 92 may provide a confirmation symbol indicating to the end user that the dose tracker 50 has reached the predefined maximum dose positional state 55. The second surface section 84 and the second indication 92 are arranged in such a distance to the tracking stop feature 51 which distance substantially corresponds to the longitudinal distance between the preselector stop feature 73 and an aperture 75 provided in the preselector 70. The aperture 75 extends radially through the preselector 70. The aperture 75 may extend through an overlapping portion of the sleeve portion 71 and the slider 72. As illustrated in
In this way and when reaching the maximum dose positional state 55 in which the tracking stop feature 51 engages with the preselector stop feature 73 the second surface portion 84 and hence the second indication 92 overlaps with and aligns with the aperture 75 so that the second surface portion 84 and the second indication 92 provided thereon becomes discernible and visible through the aperture 75. This is an indication to the end user that the maximum dose positional state 55 has been reached.
Before reaching the maximum dose positional state 55 the first surface portion 82, eventually with the first indication 91 is revealed in the aperture 75 thus indicating to the user that the maximum dose positional state 55 has not yet been reached and that dispensing should not yet commence.
On an outside surface of the sidewall 48 of the housing 10 there is further provided at least one preselection indication 45. Apparently and as illustrated in
In the sketches of
The position of the preselector 70 relative to the housing 10 is therefore indicative of the maximum dose that can be set with the dose setting mechanism 9. The indicator assembly 90 presently integrated into the preselector 70 is then indicative, that the momentary configuration and status of the dose setting mechanism 9 corresponds to the pre-set dose.
Even though the presently illustrated embodiments only show a fixing or locking of the limiter 70 or the preselector 70 at discrete positions relative to the housing 10 that correspond to consecutive and complete revolutions of the dose tracker 50 it is also conceivable that the dose tracker 50 comprises two or even three tracking stop features 51 to engage with the limiter stop feature or preselector stop feature 73. Alternatively also the preselector 70 may comprise two or more preselector stop feature 73 to engage with the tracking stop feature 51. In this way the maximum dose positional state could be assigned with every half or every third revolution of the dose tracker 50 relative to the housing 10. Furthermore it is conceivable, that two or more tracking stop feature 51 simultaneously engage with correspondingly shaped two or more preselector stop feature 73. In this way the mechanical interaction and robustness of the abutment between the dose tracker 50 and the preselector 70 can be enhanced and increased.
The sleeve portion 171 encloses a portion of an outside surface of the dose tracker 150. Also here the dose tracker 150 comprises a number sleeve 180. The dose tracker 150 also comprises a tracking stop feature 151 to abut and to engage with a correspondingly shaped preselector limiting stop feature 173. The sleeve portion 171 is connected to a slider 172 having a gripping structure 177 on an outside facing surface section. The slider also comprises a pointer 179 to point to one of the three preselection indications 45 that are arranged along the displacement path 49 of the slider 172. Even though not illustrated in detail the preselector 70 and the housing 10 comprise a detent structure 76 and a counter detent structure 46 as described in connection with
In this way the preselector 170 can be fixed and locked to the sidewall 48 of the housing 10 in any of the available preselection positional states 110, 110′, 110″.
Contrary to the example as shown in
The indicator assembly 190 further comprises a processor 420 connected to the first position sensor 430 and connected to the second position sensor 390. In this way the indicator assembly 190 is enabled to compare a measured or detected positional state 54 of the dose tracker 150 with the preselection positional state 110 of the preselector 170. Depending on the comparison the electronically implemented indicator assembly 190 is configured to provide one of at least two indicators 191, 192 as shown in
If the dose dial 12 has been rotated further so that the dose tracker 50 is screwed out of the housing 10 in proximal direction the tracking stop feature 151 engages with the preselector stop feature 173. The position of the dose tracker 150 detected by the indicator assembly 190 then reveals that the maximum dose positional state 55 has been reached. Accordingly, the indicator assembly 190 is configured to provide the second indication 192 in the second display section 414 of the display 410 thereby confirming to the user that the dose tracker 150 has reached the intended maximum dose positional state 55. In the configuration as shown in
In the first display section 412 there is provided the preselection indication 45 to which the pointer 179 of the slider 172 actually points. In the configuration of
By rotating and displacing the dose tracker 50 relative to the housing 10 along the dose incrementing direction 4 until the maximum dose positional state 55 has been reached, as shown in
The preselector 170 comprises an extension 176. In the present illustration the extension 176 is radially overlapping at least with a portion of the electronic indicator assembly 190. The extension 176 is provided with a second marker 175. The second marker 175 is configured to interact with the sensor sections 391, 392, 393 of the second position sensor 390 as shown in
In an intermediate preselection positional state 110′ the second marker 175 is aligned with the sensor section 392. In the preselection positional state 110″ representing a maximum dose the second marker 175 is aligned with the sensor section 391. The second marker 175 may be electrically conducting. Its presence or vicinity to any one of the sensor sections 391, 392, 393 can be electronically detected by means of the processor 420 of the indicator assembly 190 being electrically connected to the position sensor 390.
In a similar way the first position sensor 430 may comprise a first detector element 422 and a second detector element 424. The detector elements 422424 are arranged axially offset. They may be implemented as electrical contacts or as electromechanical switches, which upon mechanical contact with another structure or component may generate or interrupt an electrical signal that is transferrable to the processor 420. On an outside surface of the number sleeve 180 and hence on an outside surface of the dose tracker 150 there are provided two surface sections, namely a first surface section 182 and a second surface section 184. The surface sections 182, 184 comprise the shape of a helical thread.
The lead of the helical threads of the first and second surface sections 182, 184 is identical to a lead of a helical groove 181 of the dose tracker 150 or the number sleeve 180. As the dose tracker 150 is subject to a helical motion relative to the sidewall 48 of the housing 10 the first detector element 422 slides along the first surface section 182. Likewise, the second detector element 424 slides along the second surface section 184.
In the zero dose configuration as shown in
As illustrated in
After two revolutions the opposite situation occurs as illustrated in
The detector elements 421, 422, 424 can be implemented as mechanical switches when the surface sections 382, 384 and the interrupts 183, 186 comprise different radial height or depth on the outside surface of the 150. For instance, the surface sections 382, 384 each comprise a longitudinal groove on the outside surface of the number sleeve 180. The interrupts 183, 186 may flush with the outside surface of the number sleeve 180 or of the dose tracker 150. When implemented as mechanical switches, the detector elements 422, 424 may each comprise a radially displaceable and spring biased pin running along the respective surface section 182, 184 as the number sleeve 180 is subject to a rotation relative to the housing 10. When a pin of one of the detector elements 422, 424 aligns with an interrupt 183, 186 the respective pin is depressed against the action of the spring. Such a depression is accompanied by a closing or opening of an electrical switch or contact inside the detector element 422, 424.
There is further illustrated an optional detector element 421 that serves as an on-off switch for the add-on device 400. The further detector element 421 is configured to engage with a further surface section 188 on the outside surface of the number sleeve 80. The surface section 188 as illustrated in
As soon as the number sleeve 180 is subject to a rotation relative to the housing 10 the detector element 421 and the recess 188 get out of engagement. Consequently, the detector element 421 will be subject to a radially outwardly directed depression as it starts to slide outside the recessed surface section 188 and hence along the outside surface of the number sleeve 180. In this way the add-on device 400 and hence the electronic components thereof, in particular its processor 420, is switched on and the status of the further detector elements 422, 424 can be monitored and processed. By means of a detector element 421 implemented as on/off switch, electric energy consumption of the add-on device 400 can be reduced and battery lifetime can be prolonged.
When after completion of a dose dispensing procedure the detector element 421 re-engages the recessed surface section 188 the add-on device 400 is switched off and electric energy can be saved.
The first position sensor 430 and the second position sensor 390 can be implemented in many different ways. Here, the first and second surface sections 182, 184 may be provided as radial grooves while the interrupts 183, 186 protrude radially from the respective groove. Alternatively, the interrupts 183, 186 can be provided as non-conductive sections on respective first and second electrically conductive surface sections 182, 184; or vice versa. Alternatively, the first and/or second surface sections 182, 184 could be electrically or magnetically encoded. For instance, the surface sections 182, 184 may be electrically conductive while the interrupts 183, 186 are electrically insulating or non-conductive. It is also conceivable that the surface sections 182, 184 and the interrupts 183, 186 mutually distinguish in terms of their visual appearance or light absorption characteristic as well and/or with regards to their magnetic properties.
In this way also other encoding schemes based on an optic encoding or magnetic encoding can be generally implemented. With an optically or magnetically implemented encoding of the outside surface 85 of the dose tracker 150 or the number sleeve 180 also respective first and second detector elements 422, 424 should be implemented. Here, first and second detector elements 422, 424 may be implemented as light detectors or as magnetic sensors.
In a situation wherein the slider 172 is located near the proximal end of the displacement path and wherein a maximum dose has been pre-selected, i.e. with the pointer 179 of the slider 172 aligns with the preselection indication 45 provided with number 3 the configurations as shown in
These electronic components may belong to the injection device 1 and hence to the dose setting mechanism 9 thereof. The injection device 1 may be further equipped with one or several electric power sources 402, such as button batteries. The electric power sources 402 can be integrated into the housing 10 or can be detachably mounted inside the housing 10 and/or its sidewall 48.
In a further embodiment and as indicated in
Here, the injection device 1 could be void of an own indicator assembly 190. The add-on device 400 can be provided with a remote indicator assembly 490 which has the same structure as the indicator assembly 190 as described above. Here, all components belonging to the indicator assembly 190 are provided on the detachable add-on device 400, which may have a fastener or fastening structure 404 to engage with a correspondingly shaped counter fastener 406 in order to guarantee a correct and well-defined position of the add-on device 400 relative to the housing 10, to the dose tracker 150 and to the preselector 170.
The add-on device 400 is further equipped with the above mentioned first and second position sensors 430, 390 configured to detect and to determine a position of the dose tracker 150 relative to the preselector 170.
| Number | Date | Country | Kind |
|---|---|---|---|
| 17200317.0 | Nov 2017 | EP | regional |
The present application is the national stage entry of International Patent Application No. PCT/EP2018/080081, filed on Nov. 5, 2018, and claims priority to Application No. EP 17200317.0, filed on Nov. 7, 2017, the disclosures of which are incorporated herein by reference.
| Filing Document | Filing Date | Country | Kind |
|---|---|---|---|
| PCT/EP2018/080081 | 11/5/2018 | WO | 00 |
