Patent Application
20240216615
The present disclosure relates to the field of drug delivery devices and systems, e.g., to injection devices for injecting a liquid medicament. The present disclosure is generally directed to drug delivery devices and systems comprising a multi-component housing, wherein one housing component is configured to accommodate a medicament container, such as a cartridge and wherein another housing component is configured to accommodate a drive mechanism to operably engage with the medicament container for expelling or withdrawing a dose of the medicament.
Drug delivery 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.
Drug delivery devices, such as pen-type injectors, have to meet a number of user-specific requirements. For instance, with patients suffering chronic diseases, such as diabetes, the patient may be physically infirm and may also have impaired vision. Suitable drug delivery 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. Such injection devices should provide setting and subsequent dispensing of a dose of a medicament of variable size. Moreover, a dose setting as well as a dose dispensing procedure must be easy to operate and has to be unambiguous.
A patient suffering from a particular disease may require a certain amount of a medicament to either be injected via a pen-type injection syringe or infused via a pump. With respect to reusable injection or delivery devices, a patient may have to load or to replace a cartridge.
Reusable injection devices typically comprise a multi-component housing. For instance, the housing may comprise a proximal housing component, such as a body and a distal housing component, such as a cartridge holder detachably connectable to the body. Once a medicament provided in a medicament container, such as a cartridge, is empty, the cartridge holder may be disconnected from the body of the injection device and the empty cartridge may be removed and replaced with a new cartridge.
Another concern may arise from cartridges being manufactured in essentially standard sizes and manufactured to comply with certain recognized local and international standards. Consequently, such cartridges are typically supplied in standard sized cartridges (e.g., 3 ml cartridges). Therefore, there may be a variety of cartridges supplied by a number of different suppliers and containing a different medicament but fitting a single drug delivery device. As just one example, a first cartridge containing a first medicament from a first supplier may fit a drug delivery device provided by a second supplier. As such, a user might be able to load an incorrect medicament into a drug delivery device and, then, dispense said medicament (such as a rapid or basal type of insulin) without being aware that the medical delivery device was perhaps neither designed nor intended to be used with such a cartridge.
As such, there is a growing desire from users, health care providers, caregivers, regulatory entities, and medical device suppliers to reduce the potential risk of a user loading an incorrect drug type into a drug delivery device. It is also desirable to reduce the risk of dispensing an incorrect medicament (or the wrong concentration of the medicament) from such a drug delivery device.
There is, therefore, a general need to physically dedicate or mechanically code a cartridge and/or cartridge holder to its drug type and design an injection device that only accepts or works with the dedication or coded features provided on or with the cartridge and/or cartridge holder so as to prevent unwanted cartridge cross use. Similarly, there is also a general need for a dedicated cartridge that allows the medical delivery device to be used with only an authorized cartridge containing a specific medicament while also preventing undesired cartridge cross use.
In one aspect the disclosure relates to a housing of a drug delivery device, e.g., to a housing of an injection device, such as a handheld injection pen. The housing comprises a first housing component configured to accommodate a cartridge filled with a medicament. The first housing component comprises a first connecting end. The housing further comprises a second housing component. The second housing component is configured to accommodate a drive mechanism of the drug delivery device. Typically, the drive mechanism comprises a piston rod extending in longitudinal direction and configured to operably engage with a piston or bung of the cartridge for expelling a dose of the medicament from the cartridge.
The second housing component comprises a second connecting end. Typically, the first connecting end is connectable to the second connecting end to form or to constitute the housing of the drug delivery device. With some examples the first housing component is an elongated or tubular shaped housing component comprising the first connecting end at a longitudinal proximal end. The second housing component may be also of tubular or elongated shape. The second connecting end may be located at a distal longitudinal end of the second housing component.
There is further provided an insert on one of the first connecting end and the second connecting end. The insert is typically integrally formed with the respective first or second housing component. There is further provided a receptacle on the other one of the first connecting end and the second connecting end. The insert is insertable into the receptacle along the longitudinal direction for mutually fastening the first housing component and the second housing component and/or for forming or establishing the housing of the drug delivery device. Typically, the receptacle is provided at one of the first and second connecting ends and forms a respective connecting end. The insert is provided on the other one of the first and second connecting ends and forms a respective connecting end.
The receptacle comprises an inner cross-section sized and shaped to receive the insert therein. Typically, an inside diameter or inside cross-section of the receptacle closely matches an outside diameter or outer cross-section of the insert.
The housing further comprises a fastening element provided on the insert and a counter fastening element complementary shaped to the fastening element and provided in the receptacle. The fastening element comprises a snap element and the counter fastening element comprises a counter snap element to engage with the snap element.
Typically, and when reaching a final assembly configuration the fastening element engages the counter fastening element thereby fastening and fixing the first housing component to the second housing component; and vice versa. The fastening element and the counter fastening element are configured and shaped to positively engage and/or to form a form fit engagement between the first and second housing components.
At least one of the fastening element, the counter fastening element, the mechanical coding and the mechanical counter coding comprises a groove with a first groove portion and a second groove portion. The first groove portion extends along the longitudinal direction and the second groove portion extends along a circumferential direction. The second groove portion merges into the first groove portion. The mechanical coding and the mechanical counter coding being operable to prevent an engagement of the fastening element with the counter fastening element when the mechanical coding does not match the mechanical counter coding.
By providing a groove with a first groove portion and a second groove portion and kind of a L-shaped groove can be provided on one of the insert and the receptacle. The groove provides and defines a two-step assembly process. Typically, a protrusion or projection of one of the fastening element, the counter fastening element, the mechanical coding and the mechanical counter coding complementary shaped to the groove of the other one of the fastening element, the counter fastening element, the mechanical coding and the mechanical counter coding is configured to slide along the first groove portion during a first step or first phase of assembly.
When reaching an end position inside the first groove portion the insert and the receptacle are in an intermediate assembly configuration. With a matching pair of a mechanical coding and a mechanical counter coding the protrusion is then allowed to enter the second groove portion, e.g., by rotating the first housing component relative to the second housing component with regard to an axis of rotation extending parallel or coinciding with a longitudinal central axis of the elongated first housing component or of the second housing component, respectively.
This way a kind of a bayonet connection between the first housing component and the second housing component can be provided. Typically and with some examples the first groove portion is straight shaped and extends substantially perpendicular to the second groove portion.
Insofar the first and second groove portions require and define a two-step assembly process, wherein in a first assembly step the first housing component is subject to a movement relative to the second housing component along a first direction and wherein in a subsequent second step of assembly the first housing component is subject to a movement relative to the second housing component along a second direction. The first and the second directions may be perpendicular with respect to each other or may extend at a predefined non-zero angle. The first and the second directions differ from each other.
With some examples the first direction is a longitudinal direction and extends parallel to the elongation of the first groove portion. The second direction extends parallel to the second groove portion. The second groove portion may extend along a circumferential direction of a tubular-shaped sidewall of at least one of the first and second housing components.
Generally, the coding and counter coding can be provided in a variety of different ways. The coding or counter coding may be integrated or may contribute to the groove. With other examples the groove with first and second groove portions contributes to the fastening element or counter fastening element or forms the same. Then, the coding and counter coding may comprise a coding feature and complementary-shaped counter coding feature that are located offset from the groove and its first or second groove portion.
According to a further example the first groove portion adjoins a longitudinal end face of one of the first connecting end and the second connecting end. Typically, the first groove portion adjoins a longitudinal end face of a longitudinal end of a sidewall of the second housing component or first housing component. When the groove is provided on the insert of the first housing component the first groove portion adjoins a proximal end face of a sidewall of the first housing component. When the groove is integrated into the second housing component the first groove portion adjoins a distally located longitudinal end face of the sidewall of the second housing component.
By adjoining to a longitudinal end face of one of the first connecting end and the second connecting end a complementary shaped protrusion or projection of at least one of a fastening element, a counter fastening element, a mechanical coding or mechanical counter coding may engage and enter the respective first groove portion upon insertion of the insert into the receptacle. This provides a rather smooth sliding and insertion of the first housing component relative to the second housing component.
According to a further example the second groove portion merges into the first groove portion at a longitudinal distance from the longitudinal end face of one of the first and second connecting ends. With some examples the longitudinal distance between the second groove portion and the longitudinal end face of the respective connecting end may define or may contribute to a mechanical coding or counter coding. Typically, the second groove portion extends along a circumferential or transverse direction with regard to a tubular shape of first and/or second housing components. For a projection or protrusion configured to engage with the first and/or second groove portions it is required and intended that the projection or protrusion is circumferentially aligned with the second groove portion when the first and second housing components reach the intermediate assembly configuration.
With some examples the second groove portion merges into a longitudinal end of the first groove portion. The longitudinal end of the first groove portion is typically located at a longitudinal offset from one of the first and second connecting ends. With some examples the first groove portion is of rather straight and elongated shape. It has a first longitudinal end coinciding with the longitudinal end face of one of the first and second connecting ends of one of the first or second housing components, respectively. The first groove portion comprises a second longitudinal end that merges into the second groove portion. The second longitudinal end of the first groove portion is located opposite the first longitudinal end of the first groove portion.
In this way a L-shaped groove with first and second groove portions extending substantially perpendicular to each other can be provided.
According to another example one of the snap element and the counter snap element is arranged in the second groove portion or at a circumferential offset from the first groove portion. Here, the other one of the snap element and the counter snap element comprises a projection or protrusion that slides along at least a first groove portion upon inserting the insert into the receptacle. When reaching an intermediate assembly configuration the projection or protrusion will then be subject to a movement in circumferential direction. It may then slide along the second groove portion and may engage with the snap element or counter snap element provided in the second groove portion.
Alternatively, and wherein one of the snap element and the counter snap element is arranged at a circumferential offset from the first groove portion the other one of the snap element and the counter snap element may then engage with the one of the snap element and the counter snap element located at the circumferential offset from the first groove portion. Here, a respective protrusion or projection of the snap element or counter snap element may traverse a lateral border or edge of the first groove portion in order to engage with the one of the snap element and the counter snap element being located circumferentially offset from the first groove portion.
According to a further example one of the snap element and the counter snap element comprises a radial projection on one of the insert and the receptacle. The other one of the snap element and the counter snap element comprises a radial recess on the other one of the insert and the receptacle. The radial recess is configured to receive the radial projection or radial protrusion. In this way a kind of a snap fit engagement between the fastening element and the counter fastening element can be provided. The mutual engagement of the snap element with the counter snap element is typically accompanied by a slight radial deflection or radial deformation of at least one of the radial projection and the radial recess or of a respective sidewall portion that supports the radial projection or radial recesses.
This way a snap fit engagement may be easily established. Moreover, the snap fit engagement between the fastening element and the counter fastening element may provide a haptic and/or an acoustic feedback to the user, thereby inherently indicating that the snap fit connection has been established.
According to a further example the snap element is configured to engage with the counter snap element to interlock the first and second housing component against a relative movement with regards to the circumferential direction. In this way the mutually engaging of the fastening element and the counter fastening element forms a rotational interlock. When the snap element or counter snap element is located in the second groove portion the first and second housing components may be inherently locked in longitudinal or axial direction as soon as a projection enters the second groove portion in the course of a mutual assembly of the first and second housing components.
Insofar, the L-shaped groove featuring the first and the second groove portion inherently provides an axial interlock, namely when a protrusion or projection enters the second groove portion extending in circumferential direction.
According to a further example the coding feature of the first mechanical coding distinguishes from a coding feature of another mechanical coding with regard to at least one of a number of coding features, a longitudinal position, a longitudinal extent, a circumferential position, a circumferential extent and/or by a cross-sectional geometry or shape in a plane transverse to the longitudinal direction. Likewise, and according to further examples the counter coding feature of a first mechanical counter coding distinguishes from a counter coding feature of another mechanical counter coding with regard to at least one of a number of coding features, a longitudinal position, a longitudinal extent, a circumferential position, a circumferential extent and/or a cross-sectional geometry or shape in a plane transverse to the longitudinal direction.
According to a further example the mechanical coding is integrated into the snap element. The mechanical counter coding is integrated into the counter snap element. Moreover, and the other way around the snap element may be integrated into the mechanical coding and the counter snap element may be integrated into the mechanical counter coding. In this way, the coding may be defined by a position, extent, orientation of cross-sectional geometry of the snap element. The counter coding may be defined by the position, extent and/or by the cross-sectional geometry or shape of the counter snap element. Here, the snap element fulfills a twofold or double function. The same is valid for the mechanical coding and mechanical counter coding.
The mechanical coding and counter coding may not only provide a mechanical code to distinguish between housing components of different housings of the drug delivery devices but may equally serve to connect, e.g., non-releasably or releasably and mutually connect the first housing component and the second housing component.
According to a further example the coding feature is defined by a longitudinal position and by a longitudinal extent of the snap element on the insert. Correspondingly, the counter coding feature is defined by a longitudinal position and by a longitudinal extent of the counter snap element in the receptacle. In other words, the coding feature and/or the counter coding feature are defined by a longitudinal position versus a longitudinal extent of the snap element and the counter snap element, respectively. In this way, a rather unique coding and counter coding can be provided. Thus, it can be ensured, that one combination of a longitudinal position and a longitudinal extent of a coding feature only matches with a single counter coding features of a number of available counter coding features.
A first type of a mechanical coding can only be connected with a first type of the mechanical counter coding. Second and third types of a mechanical codings are hindered to engage or to cooperate with second or third types of mechanical counter codings. Types of codings and counter codings distinguish by the longitudinal position and by the longitudinal extent of the snap element on the insert and/or by the longitudinal position and/or by longitudinal extent of the counter snap element in the receptacle.
According to a further example the coding feature and the counter coding feature comprise a radial protrusion on one of the insert and the receptacle and a radial coding recess on the other one of the insert and the receptacle. With some examples the radial coding protrusion is separated from the radial projection of the snap element or counter snap element. The radial coding recess may be separated from the radial recess of the snap element or counter snap element. With some examples the radial coding protrusion may coincide with a radial projection of the snap element or counter snap element. Then, the radial coding recess may also coincide with the radial recess of one of the snap element and the counter snap element.
With some examples the radial coding recess coincides with the groove featuring a first groove portion, e.g., extending in longitudinal direction and featuring a second groove portion, e.g., extending in circumferential direction. When implementing the coding feature and the counter coding features separate from the fastening element and the counter fastening element, the function of the mechanical coding and the function of mechanically connecting the first and the second housing components can be separated from each other.
Here, the fastening element and the counter fastening element may be shaped and implemented in the same way for all types of differently available codings. This might be beneficial from a manufacturing point of view. Then, the mutual fixing of first and second housing components is not affected by variations of the mechanical coding and the mechanical counter coding.
According to a further example and when the mechanical coding matches the mechanical counter coding the radial coding protrusion fits into the radial coding recess.
According to further examples and when the mechanical coding does not match the mechanical counter coding the radial coding protrusion does not fit into the radial coding recess. Non-matching or incompatible coding recesses and coding protrusions may be provided by different cross-sectional geometries of respective coding features and counter coding features.
A non-matching or incompatible pair of a coding and a counter coding may be also obtained by an arrangement of a mechanical coding feature with regard to a mechanical counter coding feature, wherein the mechanical coding feature does not spatially overlap with the mechanical counter coding feature. Hence, at least in an intermediate or final position of assembly of the first and second housing components the mechanical coding or mechanical coding feature does not overlap a mechanical counter coding or mechanical counter coding feature.
According to a further example the coding feature is a longitudinal position versus a longitudinal extent of one of the radial coding protrusion and the radial coding recess on an outside surface of the insert. Accordingly, the counter coding feature is a longitudinal position versus a longitudinal extent of one of the radial coding protrusion and the radial coding recess on an inside surface of the receptacle.
According to another example the mechanical coding is defined by a combination of a position of the coding feature with regard to the longitudinal direction and an extent of the coding feature in the longitudinal direction. Here, the mechanical coding is subject to a twofold variation or the mechanical coding is defined by two independent parameters, namely by the longitudinal position of the coding feature and by the longitudinal extent of the coding feature.
According to another example at least one of the mechanical coding and the mechanical counter coding comprises the groove as mentioned above. Then, the coding feature and the counter coding feature distinguish from coding features and counter coding features of another housing by varying the longitudinal position of the second groove portion and the longitudinal position of the radial coding protrusion correspondingly. Here, an increase of a longitudinal distance of the second groove portion from a free end of one of the first and second connecting end is accompanied by or combined with an increase of the longitudinal extend and/or transverse extend of the second groove portion and further by a corresponding decrease of a distance of the radial coding protrusion from the other one of the first and second connecting end and a corresponding increase of the longitudinal extent and/or transverse extend of the radial coding protrusion.
Here, variations applying to the longitudinal or transverse or circumferential extent of the groove portion equally applies to a respective variation of the longitudinal and/or transverse or circumferential extent of the corresponding radial coding protrusion. With regard to a variation of the longitudinal position, hence a variation of the longitudinal distance of the second groove portion from a free end, the respective radial coding protrusion is shifted accordingly in longitudinal direction so that it overlaps and engages with the second groove portion when reaching at least the intermediate assembly configuration.
In this way it can be effectively provided and guaranteed, that a mechanical coding of a first type is exclusively engageable with the complementary shaped mechanical counter coding of the first type. The above-mentioned variation of a coding or counter coding from a first type towards a second type, e.g., by simultaneously modifying the longitudinal position and at least one of a longitudinal and a circumferential extent of the respective coding feature prevents an inadvertent engagement of a coding feature of a first type with a counter coding feature of a second or third type; and vice versa.
According to a further example at least one of the mechanical coding and the mechanical counter coding comprises the above-mentioned groove. At least one of the fastening element and the counter fastening element comprises another groove located circumferentially offset from the groove. The another or supplemental groove comprises a first groove portion and a second groove portion. The first groove portion extends along the longitudinal direction. The second groove portion extends along the circumferential direction and merges into the first groove portion. In this way, at least a first and a second L-shaped groove is provided on one of the insert and the receptacle.
In this way, a twofold mechanical engagement can be provided, namely between the mechanical coding and the mechanical counter coding as well as between the fastening element and the counter fastening element. Accordingly, a mechanical rigidity and stability of the interconnect between the first and second housing components can be improved and enhanced.
According to another example one of the coding feature and the counter coding feature is defined by a circumferential distance between the first groove portion of the groove and the first groove portion of the another groove. The first groove portion of the another groove may also adjoin a longitudinal end face of one of the first connecting end and the second connecting end. With some examples the groove and the another groove are provided on the same or on a common housing component. With other examples the groove is provided on one of the first and second housing components and the another groove is provided on the other one of the first and second housing component.
In either way and when the groove and the another groove are provided on a common housing component respective projections or protrusions are provided on the other housing component. Then, a simultaneous engagement of a first and a second protrusion into the groove and into the another groove, respectively is only possible, when the circumferential distance between the projection and the protrusion matches the circumferential distance between the groove and the another groove.
The same is equally valid when the first housing component comprises the groove and a projection and when the second housing component comprises the another groove and a protrusion.
According to a further example the insert comprises a visible or visual indicator on an outside surface and the receptacle comprises a through recess in a sidewall. The indicator is visible through the through recess when the insert is correctly assembled and fixed inside the receptacle. The indicator matches in shape and size with the through recess. The indicator is positioned on the outside surface of the insert such that when reaching a correct final assembly configuration the indicator spatially overlaps with the through recess. Accordingly, and when correctly assembled the visual indicator is visible through the through recess from outside the housing. Typically, the visual indicator distinguishes from the visual appearance of the outside surface of the insert at least by its color, brightness, and/or texture. The spatially overlapping arrangement of the visual indicator and the through recess provides a visual feedback to the user, that a correct and final assembly configuration of the first and second housing components has been obtained.
According to another aspect there is provided an injection device for injecting a dose of a medicament. The injection device comprises a housing as described above and a cartridge arranged inside the housing. The cartridge comprises a barrel filled with a medicament and sealed in a proximal longitudinal direction by a movable bung. The injection device further comprises a drive mechanism arranged inside the housing. The drive mechanism comprises a piston rod operable to exert a distally directed dispensing force onto the bung of the cartridge. Typically, the injection device is implemented as a hand held or portable injection device. The injection device may comprise a pen-type injector.
With some examples the receptacle is provided as a housing insert fixedly attachable or fixedly attached to an elongated housing component, e.g., the first or second housing component of the housing of the drug delivery device. The housing insert may be rotationally and/or longitudinally fixed to the elongated housing component. Insofar all features and benefits as described above in connection with the receptacle equally apply to a housing insert fixedly connectable or fixedly connected to a respective housing component.
According to another aspect the present disclosure relates to a kit of at least a first housing as described above and at least a second housing as described above. Here, the coding feature of the first housing distinguishes from the coding feature of the second housing with regard to at least one of a number of coding features, a longitudinal position, a longitudinal extent, a circumferential position, a circumferential extent and/or a cross-sectional geometry or shape in a plane transverse to the longitudinal direction. Likewise, also the first housing comprises a first counter coding feature that distinguishes from a respective counter coding feature of the second housing with regard to at least one of the above-mentioned features, a longitudinal position, a longitudinal extent, a circumferential position, a circumferential extent and/or a cross-sectional geometry or shape in a plane transverse to the longitudinal direction.
Here, only the housing components of the first housing equipped with complementary shaped mechanical codings and mechanical counter codings are allowed and supported to become mutually fastened and fixed. The first housing is provided with a pair of a coding and counter coding of a first type. A second housing is provided with a pair of a coding and counter coding of a second type. A coding of the first type is incompatible with a counter coding of the second type. A counter coding of the first type is incompatible with a coding of the second type. A user trying to assemble a housing component of the first housing with a housing component of the second housing will be hindered to do so by not-matching mechanical codings and mechanical counter codings.
Generally, and with some examples the first housing components of different housings may distinguish by the size and/or geometry of an accommodating space for receiving a medicament container or cartridge. In particular, a housing with a coding of a first type may be exclusively equipped with a first cartridge or medicament container. A housing with a coding of a second type may be exclusively equipped with a cartridge or a second medicament container. For this, medicament containers, cartridges as well as the interior of the first housing components may comprise further codings or coding features or may distinguish with regard to their size or geometry such that only one dedicated cartridge or medicament container unequivocally fits into only one dedicated first housing component.
With some examples, the first housing component is provided with a mechanical coding to engage with a complementary shaped counter coding of a cartridge. With further examples the first housing component may be provided with at least one of an electronic, a visual or optical coding configured to match with a complementary counter coding of the cartridge, which is also of electronic, visual or optical type.
Moreover, at least one of the cartridge and the first housing component may be provided with a locking or fastening feature by way of which a cartridge can be fixed and/or retained in the first housing component. Here, the first housing component, e.g., implemented as a cartridge holder, and a cartridge assembled therein can be provided as a pre-fabricated housing assembly or as a dedicated cartridge-cartridge holder combination.
In either way, it can be assured or provided that a particular medicament provided in a particular cartridge is unequivocally associated with a particular type of a first housing component, i.e., with a particularly mechanically encoded first housing component. In effect and with some examples, a cartridge provided with a particular medicament can be only accommodated in a correspondingly shaped first housing component equipped with a respective mechanical coding.
With further examples a pre-fabricated housing assembly or a dedicated cartridge-cartridge holder combination is commercially distributed by a pharmaceutical manufacturer. Here, the cartridge may be undetachably or irremovably fixed inside the first housing component and the pharmaceutical manufacturer provides a respective matching between a cartridge filled with a particular medicament and a suitable first housing component, which is mechanically encoded in accordance to the type of medicament located inside the cartridge.
According to a further aspect the present disclosure also relates to a kit of injection devices. The kit of injection devices comprises at least a first injection device comprising a first housing provided with a coding and a counter coding both of a first type and further comprises a second injection device with a second housing provided and equipped with a coding and a counter coding both of a second type non-matching with the respective counter coding or coding of the first type.
Generally, the scope of the present disclosure is defined by the content of the claims. The injection device is not limited to specific embodiments or examples but comprises any combination of elements of different embodiments or examples. Insofar, the present disclosure covers any combination of claims and any technically feasible combination of the features disclosed in connection with different examples or embodiments.
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 terms “drug” or “medicament” are used synonymously herein and describe a pharmaceutical formulation containing one or more active pharmaceutical ingredients or pharmaceutically acceptable salts or solvates thereof, and optionally a pharmaceutically acceptable carrier. An active pharmaceutical ingredient (“API”), in the broadest terms, is a chemical structure that has a biological effect on humans or animals. In pharmacology, a drug or medicament is used in the treatment, cure, prevention, or diagnosis of disease or used to otherwise enhance physical or mental well-being. A drug or medicament may be used for a limited duration, or on a regular basis for chronic disorders.
As described below, a drug or medicament can include at least one API, or combinations thereof, in various types of formulations, for the treatment of one or more diseases. Examples of API may include small molecules having a molecular weight of 500 Da or less; polypeptides, peptides and proteins (e.g., hormones, growth factors, antibodies, antibody fragments, and enzymes); carbohydrates and polysaccharides; and nucleic acids, double 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 may be incorporated into molecular delivery systems such as vectors, plasmids, or liposomes. Mixtures of one or more drugs are also contemplated.
The drug or medicament may be contained in a primary package or “drug container” adapted for use with a drug delivery device. The drug container may be, e.g., a cartridge, syringe, reservoir, or other solid or flexible vessel configured to provide a suitable chamber for storage (e.g., short- or long-term storage) of one or more drugs. For example, in some instances, the chamber may be designed to store a drug for at least one day (e.g., 1 to at least 30 days). In some instances, the chamber may be designed to store a drug for about 1 month to about 2 years. Storage may occur at room temperature (e.g., about 20° C.), or refrigerated temperatures (e.g., from about −4° C. to about 4° C.). In some instances, the drug container may be or may include a dual-chamber cartridge configured to store two or more components of the pharmaceutical formulation to-be-administered (e.g., an API and a diluent, or two different drugs) separately, one in each chamber. In such instances, the two chambers of the dual-chamber cartridge may be configured to allow mixing between the two or more components prior to and/or during dispensing into the human or animal body. For example, the two chambers may be configured such that they are in fluid communication with each other (e.g., by way of a conduit between the two chambers) and allow mixing of the two components when desired by a user prior to dispensing. Alternatively or in addition, the two chambers may be configured to allow mixing as the components are being dispensed into the human or animal body.
The drugs or medicaments contained in the drug delivery devices as described herein can be used for the treatment and/or prophylaxis of many different types of medical disorders. Examples of disorders include, e.g., diabetes mellitus or complications associated with diabetes mellitus such as diabetic retinopathy, thromboembolism disorders such as deep vein or pulmonary thromboembolism. Further examples of disorders are acute coronary syndrome (ACS), angina, myocardial infarction, cancer, macular degeneration, inflammation, hay fever, atherosclerosis and/or rheumatoid arthritis. Examples of APIs and drugs are those as described in handbooks such as Rote Liste 2014, for example, without limitation, main groups 12 (anti-diabetic drugs) or 86 (oncology drugs), and Merck Index, 15th edition.
Examples of APIs for the treatment and/or prophylaxis of type 1 or type 2 diabetes mellitus or complications associated with type 1 or type 2 diabetes mellitus include an insulin, e.g., human insulin, or a human insulin analogue or derivative, a glucagon-like peptide (GLP-1), GLP-1 analogues or GLP-1 receptor agonists, or an analogue or derivative thereof, a dipeptidyl peptidase-4 (DPP4) inhibitor, or a pharmaceutically acceptable salt or solvate thereof, or any mixture thereof. As used herein, the terms “analogue” and “derivative” refers to a polypeptide which has a molecular structure which formally can be derived from the structure of a naturally occurring peptide, for example that of human insulin, by deleting and/or exchanging at least one amino acid residue occurring in the naturally occurring peptide and/or by adding at least one amino acid residue. The added and/or exchanged amino acid residue can either be codable amino acid residues or other naturally occurring residues or purely synthetic amino acid residues. Insulin analogues are also referred to as “insulin receptor ligands”. In particular, the term “derivative” refers to a polypeptide which has a molecular structure which formally can be derived from the structure of a naturally occurring peptide, for example that of human insulin, in which one or more organic substituent (e.g. a fatty acid) is bound to one or more of the amino acids. Optionally, one or more amino acids occurring in the naturally occurring peptide may have been deleted and/or replaced by other amino acids, including non-codeable amino acids, or amino acids, including non-codeable, have been added to the naturally occurring peptide. 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, 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.
Examples of insulin derivatives are, for example, B29-N-myristoyl-des(B30) human insulin, Lys(B29) (N-tetradecanoyl)-des(B30) human insulin (insulin detemir, Levemir®); B29-N-palmitoyl-des(B30) human insulin; B29-N-myristoyl human insulin; B29-N-palmitoyl human insulin; B28-N-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.
Examples of GLP-1, GLP-1 analogues and GLP-1 receptor agonists are, for example, Lixisenatide (Lyxumia®), Exenatide (Exendin-4, Byetta®, Bydureon®, a 39 amino acid peptide which is produced by the salivary glands of the Gila monster), Liraglutide (Victoza®), Semaglutide, Taspoglutide, Albiglutide (Syncria®), Dulaglutide (Trulicity®), rExendin-4, CJC-1134-PC, PB-1023, TTP-054, Langlenatide/HM-11260C (Efpeglenatide), HM-15211, CM-3, GLP-1 Eligen, ORMD-0901, NN-9423, NN-9709, NN-9924, NN-9926, NN-9927, Nodexen, Viador-GLP-1, CVX-096, ZYOG-1, ZYD-1, GSK-2374697, DA-3091, MAR-701, MAR709, ZP-2929, ZP-3022, ZP-DI-70, TT-401 (Pegapamodtide), BHM-034. MOD-6030, CAM-2036, DA-15864, ARI-2651, ARI-2255, Tirzepatide (LY3298176), Bamadutide (SAR425899), Exenatide-XTEN and Glucagon-Xten.
An example of an oligonucleotide is, for example: mipomersen sodium (Kynamro®), a cholesterol-reducing antisense therapeutic for the treatment of familial hypercholesterolemia or RG012 for the treatment of Alport syndrome.
Examples of DPP4 inhibitors are Linagliptin, Vildagliptin, Sitagliptin, Denagliptin, Saxagliptin, Berberine.
Examples of hormones include hypophysis hormones or hypothalamus hormones or regulatory active peptides and their antagonists, such as Gonadotropine (Follitropin, Lutropin, Choriongonadotropin, Menotropin), Somatropine (Somatropin), Desmopressin, Terlipressin, Gonadorelin, Triptorelin, Leuprorelin, Buserelin, Nafarelin, and Goserelin.
Examples of polysaccharides include 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 polysaccharide, 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. An example of a hyaluronic acid derivative is Hylan G-F 20 (Synvisc®), a sodium hyaluronate.
The term “antibody”, as used herein, refers to an immunoglobulin molecule or an antigen-binding portion thereof. Examples of antigen-binding portions of immunoglobulin molecules include F(ab) and F(ab′)2 fragments, which retain the ability to bind antigen. The antibody can be polyclonal, monoclonal, recombinant, chimeric, de-immunized or humanized, fully human, non-human, (e.g., murine), or single chain antibody. In some embodiments, the antibody has effector function and can fix complement. In some embodiments, the antibody has reduced or no ability to bind an Fc receptor. For example, the antibody can be an isotype or subtype, an antibody fragment or mutant, which does not support binding to an Fc receptor, e.g., it has a mutagenized or deleted Fc receptor binding region. The term antibody also includes an antigen-binding molecule based on tetravalent bispecific tandem immunoglobulins (TBTI) and/or a dual variable region antibody-like binding protein having cross-over binding region orientation (CODV).
The terms “fragment” or “antibody fragment” refer to a polypeptide derived from an antibody polypeptide molecule (e.g., an antibody heavy and/or light chain polypeptide) that does not comprise a full-length antibody polypeptide, but that still comprises at least a portion of a full-length antibody polypeptide that is capable of binding to an antigen. Antibody fragments can comprise a cleaved portion of a full length antibody polypeptide, although the term is not limited to such cleaved fragments. Antibody fragments that are 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 (SMIP), binding-domain immunoglobulin fusion proteins, camelized antibodies, and VHH containing antibodies. Additional examples of antigen-binding antibody fragments are known in the art.
The terms “Complementarity-determining region” or “CDR” refer to short polypeptide sequences within the variable region of both heavy and light chain polypeptides that are primarily responsible for mediating specific antigen recognition. The term “framework region” refers to amino acid sequences within the variable region of both heavy and light chain polypeptides that are not CDR sequences, and are primarily responsible for maintaining correct positioning of the CDR sequences to permit antigen binding. Although the framework regions themselves typically do not directly participate in antigen binding, as is known in the art, certain residues within the framework regions of certain antibodies can directly participate in antigen binding or can affect the ability of one or more amino acids in CDRs to interact with antigen. 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).
Pharmaceutically acceptable salts of any API described herein are also contemplated for use in a drug or medicament in a drug delivery device. Pharmaceutically acceptable salts are for example acid addition salts and basic salts.
Those of skill in the art will understand that modifications (additions and/or removals) of various components of the APIs, formulations, apparatuses, methods, systems and embodiments described herein may be made without departing from the full scope and spirit of the present invention, which encompass such modifications and any and all equivalents thereof.
It will be further apparent to those skilled in the art that various modifications and variations can be made to the present disclosure without departing from the scope of the disclosure.
In the following, numerous examples of injection devices with dedicated or coded housing components will be described in greater detail by making reference to the drawings, in which:
In
The first housing component 100 is typically configured to accommodate a cartridge 6 that is filled with a liquid medicament. The cartridge 6 comprises a cylindrically-shaped or tubular-shaped barrel 25 sealed in proximal direction 3 by means of a bung 7 located inside the barrel 25. The bung 7 is displaceable relative to the barrel 25 of the cartridge 6 in a distal direction 2 by means of a piston rod 20. A distal end of the cartridge 6 is sealed by a pierceable seal 26 configured as a septum and being pierceable by a proximally directed tipped end of the injection needle 15. The cartridge holder and hence the first housing component 100 comprises a threaded socket 28 at its distal end to threadedly engage with a correspondingly threaded portion of the injection needle 15. By attaching the injection needle 15 to the distal end of the first housing component 100 the seal 26 of the cartridge 6 is penetrated thereby establishing a fluid transferring access to the interior of the cartridge 6.
When the injection device 1 is configured to administer, e.g., human insulin, the dosage set by a dose 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). The dose dial 12 may comprise or may form a dose dial.
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 click sound is typically generated by a click noise generator 45. Generally, a click noise generator 45 may be implemented in various different ways. 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 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, the dose is actually injected into the patient's body. Ejection of a dose of the liquid medicament may also cause a mechanical click sound, which is however different from the click sound produced when using the dose dial 12. For this, the injection device one may comprise a separate, hence a second click noise generator (not illustrated).
In this embodiment, during delivery of the insulin dose, the dose 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.
An example of the drive mechanism 8 is 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, e.g., to the second housing component 200. 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.
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 there between. 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 click noise generator 45, and the clutch 60 engaged, the drive sleeve 30, the spring 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 to prevent further movement in a first sense of rotation, e.g. 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. Here, the clutch may serve as a ratchet mechanism.
As an alternative or in addition the ratchet mechanism 90 may comprise at least one ratchet feature 91, such as a flexible arm on the sidewall of the tubular-shaped clutch 60. The at least one ratchet feature 91 may comprise a radially outwardly extending protrusion e.g. on a free end of the flexible arm. The protrusion is configured to engage with a correspondingly shaped counter ratchet structure on an inside of the number sleeve 80. The inside of the number sleeve 80 may comprise longitudinally shaped grooves or protrusions featuring a saw-tooth profile.
During dialing or setting of a dose the ratchet mechanism 90 allows and supports a rotation of the number sleeve 80 relative to the clutch 60 along a second sense of rotation 5, which rotation is accompanied by a regular clicking of the flexible arm of the clutch 60. An angular momentum applied to the number sleeve 80 along the first sense of rotation for is unalterably transferred to the clutch 60. Here, the mutually corresponding ratchet features of the ratchet mechanism 90 provide a torque transmission from the number sleeve 80 to the clutch 60.
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 housing 10 as illustrated in any of the
The first connecting end 101 is mechanically connectable to the second connecting end 201. As illustrated, the first housing component 100 comprises an insert 110 forming the first connecting end 101. The second housing component 200 comprises a receptacle 210 shaped and sized to receive the insert 110. The insert 110 is insertable into the receptacle 210 by a longitudinal sliding movement relative to the second housing component 200, in particular along the proximal direction 3.
The insert 110 forms a proximal end of the first housing component 100. The insert 110 comprises a proximal end face 112. Towards the distal direction 2 the insert 110 is confined by a flange section 115 protruding radially outwardly from the tubular shaped sidewall 102 of the first housing component 100 and hence also from a sidewall 102 of insert 110.
The flange section 115 comprises a circumferential rim extending all around the tubular shaped insert 110. Towards the proximal direction 3 the flange section 115 comprises an abutment face 114 facing in proximal direction 3. The abutment faces 114 is configured to axially abut a distal end face 214 of the sidewall 202 of the second housing component.
For mutually fixing the first and second housing components 100, 200 there is provided a fastening element 120 on the insert 110 to operably engage with a correspondingly or complementary-shaped counter fastening element 220 provided inside the receptacle 210. In the presently illustrated examples, as for instance shown in greater detail in
The proximal connecting end 101 of the first housing component 100 is provided with a mechanical coding 150 comprising a mechanical coding feature 151. Here, the mechanical coding feature 151 comprises a coding protrusion 152 protruding radially outwardly from a sidewall of the insert 110. As illustrated in
Only when the geometry of the radial protrusion 152 matches the cross-sectional geometry of the complementary shaped radial recess 252 the respective protrusion 152 can be inserted in longitudinal direction (z) into the radial recess 252 in the course of inserting the insert 110 into the receptacle 210 as provided at the distal connecting and 201 of the second housing component.
The first and second housing components 100, 200 are further equipped and provided with a fastening element 120 and with a complementary-shaped counter fastening element 220. In the illustrated example the fastening element 120 comprises a radially outwardly extending protrusion 122 forming a snap element 121. The complementary-shaped counter fastening element 220 comprises a counter snap element 221 to positively engage with the snap element 121 when reaching a final assembly configuration.
The counter fastening element 220 comprises a groove 224 that is provided as a radial recess 222 on the inside surface 203 of the sidewall 202 of the receptacle 210. The groove 224 comprises a first groove portion 225 and a second groove portion 226. The first and second groove portions 225, 226 extend in different directions. The first groove portion 225 adjoins the distal end face 214 of the sidewall 202 and extends in longitudinal direction of the second housing component 200. The second groove portion 226 merges into the first groove portion 225 and extends in circumferential direction (w).
The L-shaped groove 224 defines and requires a two-step assembly process. During a first step of assembly the insert 110 of the housing component 100 is inserted into the receptacle 210 along the longitudinal direction (z) without any rotation. When reaching an intermediate assembly configuration, e.g. when the flange section 115 or the proximally facing abutment face 114 thereof longitudinally abuts with the distal end face 214 the longitudinally directed insert motion is blocked. Then, and during a second step of assembly the first housing component 100 is subject to a rotation relative to the second housing component 200 with an axis of rotation coinciding or extending parallel to a longitudinal axis of the tubular-shaped sidewall 102 of the housing component 100.
As illustrated in
The mechanical counter coding 250 may comprise a geometry or shape that directly matches and corresponds with the shape of the groove 224. Even though not illustrated the mechanical counter coding 250 may also comprise a radial recess in form of a L-shaped groove 254 with a first groove portion 255 and a second groove portion 256. An example of such a mechanical counter coding is for instance shown in
In
Any one of the coding features 151, 151′, 151″ distinguishes from the other two of the coding features 151, 151′, 151″ at least with regards to the radial extent and/or circumferential extent. In this way, it can be guaranteed, that each one of the mechanical coding features 151, 151′, 151″ can engage with only one of a complementary-shaped counter coding feature, which are not illustrated in greater detail here.
The mechanical coding 150, 150′, 150″ is at a well-defined circumferential position relative to the radial protrusion 122 of the fastening element 120, which is configured to engage with the groove 224. With the examples of
In the further example of
Both grooves 224, 254 are in L-shaped. Here, the second groove portion 226, 256 extends substantially perpendicular to the elongation of the first groove portion 225, 255. The first groove portion 225 of the groove 224 distinguishes with regard to a cross-section or shape from the first groove portion 255 of the further groove 254. This requires, that the insert 110 can only be inserted in a well-defined orientation into the receptacle.
As indicated by the illustration of the receptacle 210 of
As further illustrated in
The coding 150 and the counter coding 250 may be defined by a number of coding features, e.g. by defining a longitudinal position, e.g. of the second groove portion 256 relative to the longitudinal position of the second groove portion 226. The coding may be further defined by a longitudinal or transverse extent of the second groove portion 256. The coding may be further defined by a circumferential position of the supplemental coding groove 254 relative to the groove 224. Moreover, the coding may be defined by a cross-sectional geometry or shape of the coding feature 151 and the complementary-shaped counter coding feature 251 in the plane transverse or perpendicular to the longitudinal direction.
The visual indicator 158 is located at a well-defined position nearby or close to the coding feature 151. In the sidewall 202 of the receptacle 210 there is provided a through recess 258. As illustrated, the through recess 258 intersects a portion of the groove 254. It may be located in the first groove portion 255. When appropriately assembled and when the first and second housing components 100, 200 are in a final assembly configuration the visual indicator 158 spatially overlaps with the through recess 258. Then, and when correctly assembled the visual indicator 158 is visible through the through recess 258.
In this way, a visual feedback can be provided to the user, that the first and the second housing component 100, 200 are correctly assembled.
By providing a snap element 121 separately from the mechanical coding 150 it can be provided, that for each type of different codings and counter codings there will be used one and the same and hence a non-modified fastening mechanism for fastening and fixing the first and second housing components together. A variation of the coding and of the respective counter coding then will have no influence on the fastening mechanism as such.
In
In the example of
In
With the further example of a fourth type of a coding 150″ complementary shaped to a respective counter coding 250″ the circumferential or transverse position of the coding 150″ has been further shifted counterclockwise compared to the mechanical coding 150″ of the third type as shown in
With the example of
In
In the illustrated example the fastening element 320 is integrated into the coding feature 350. Here, the fastening element 320 comprises a snap element 321. The fastening element 320 comprises a radial protrusion 322 protruding radially outwardly on the outside surface 105 of the sidewall 102. The radial protrusion 322 comprises an elongated rib aligned along the longitudinal direction. In the illustrated example the radial protrusion 322 adjoins the end face 112.
The counter coding feature 450 as illustrated in
The first groove portion 455 extends in longitudinal direction. It is rather straight shaped and extends from the end face 214 towards the oppositely located end face 212 formed by a radially inwardly extending flange portion of the sidewall 202 and delimiting the receptacle 210 towards the proximal direction 3. The second groove portion 456 extends in circumferential direction (w). The second groove portion 456 merges into the first groove portion 455. The first groove portion 455 and the second groove portion 456 form a L-shaped coded groove 454. In the illustrated example the second groove portion 456 adjoins the distal side of the end face 212.
The coded groove 454 coincides with a groove 424 of the counter fastening element 420. In other words, the counter fastening element 420 and the counter coding 450 share the same geometric structure on the inside surface 203 of the receptacle 210. In other words, the counter fastening element 420 is integrated into the mechanical counter coding 450. Vice versa, the mechanical counter coding 450 is integrated into the counter fastening element 420. In this way, the counter fastening element 420 comprises a counter snap feature 421 to engage with the snap feature 321 of the fastening element 320. The counter fastening element 420 comprises a raised ridge 423 and a recess 422. The recess 422 and the raised ridge 423 constitute or form the counter snap element 421 to engage with the snap element 321 of the fastening elements 320.
As illustrated the raised ridge 423 comprises a radially inwardly extending protrusion at or near a dead end of the second groove portion 426. Here, the second groove portion 426 coincides with the second groove portion 456. A first groove portion 425 coincides with the first groove portion 455.
For connecting the first connecting end 101 to the second connecting end 201 the insert 110 is inserted into the receptacle 210 along the longitudinal direction. In order to enable a longitudinal sliding insert motion of the insert 110 into the receptacle 210 the fastening element 320 and hence the coding feature 350 has to be aligned with the complementary-shaped counter fastening element 420 and the respective counter coding feature 450, respectively. When appropriately aligned, the radial protrusion 322, 352 can be inserted into the first groove portion 425, 455. The insert 110 is then allowed to move in longitudinal direction relative to the second housing component 200 until the longitudinal end face 112 get in axial abutment with the end face 212 of the receptacle.
Then, an intermediate assembly configuration has been reached. If appropriate encoded, hence if the holding 350 matches the counter coding 450 the coding feature 351 matches with the counter coding feature 451 with regards to its longitudinal position as well as with regard to its longitudinal extend. Then in the intermediate assembly configuration the radial protrusion 322, 352 is longitudinally aligned with the second groove portion 426, 456 and the longitudinal extent of the protrusion 322, 352 matches a longitudinal width of the second groove portion 426, 456.
Then and in a second step of assembly the first housing component 100 and hence the insert 110 is allowed to be rotated clockwise relative to the receptacle 210 with a longitudinal central axis of the housing component 100, 200 as an axis of rotation. As a consequence, the radial protrusion 322, 352 enters the second groove portion 426, 456 until the radial protrusion 322 and hence the snap feature 321 positively engages with the counter snap element 421.
Finally, and when reaching a final assembly configuration the protrusion 322, 352 is located in the radial recess 422 at the dead end of the second groove portion 426, 456, which is opposite to that particular end of the second groove portion 426, 456 that merges into the first groove portion 425, 455.
With the example of
In
The second groove portion 426, 456 of the counter fastening element 420 and of the counter coding 451′ is located at a distance from the longitudinal end face 214 that is smaller than the respective distance as shown in the example of
Apart from that the overall geometry of the receptacle 210 and of the insert 110 have remain substantially unamended and the cross-section of the groove 455 of the counter coding feature 451′ of the second type is identical to the cross-section of the first groove portion 455 of the counter coding feature 451 of the first type.
The coding 350 and counter coding 450 of a first type as illustrated in
Vice versa, the mechanical coding 350′ of the second type is incompatible with the mechanical counter coding 450 of the first type. It may be possible to insert the insert 110 as illustrated in
Accordingly, a rotation of the insert 110 relative to the receptacle 210 with the longitudinal axis as an axis of rotation is effectively blocked and impeded. The non-matching or in compatible coding and counter coding of first and second types prevent and block an engagement of the fastening element 320 engaging the counter fastening element 420.
As a general rule and for establishing a kit of at least a first housing 10 and a second housing 10′ it is provided that an increase of a longitudinal distance of a radial recess 452, hence the longitudinal position of the second groove portion 426, 456 from a free end of the respective connecting end 201 is accompanied by an increase of the longitudinal extend of the radial recess and buy a corresponding increase of the distance and the longitudinal extend of the correspondingly shaped radial protrusion 352. The larger the longitudinal extent of the protrusion 352 the larger should be the distance of the radial protrusion 352 from a free end of the respective connecting end 101.
Numerous examples of different codings 350, 350′, 350″ and correspondingly shaped counter codings 450, 450′, 450″ are illustrated in the sequence of
As becomes apparent from a comparison of the number of codings 350, 350′, 350″ the longitudinal position of a coding protrusion 352, 352′, 352″ changes together with the longitudinal extent of the respective radial protrusion 352, 352′, 352″. As can be seen by a comparison of the coding 350 of a first type with the coding 350′ of a second type the longitudinal extent of the protrusion 352′ is larger than the longitudinal extent of the protrusion 352.
Also, the longitudinal position and hence the longitudinal distance between the radial protrusion 352′ to the longitudinal end face 112 is shorter with the second type of a coding 350′ than a longitudinal distance between the protrusion 352 and the end face 112 with the first type of a coding 350. In the same way and when comparing the coding 350′ and the respective coding feature 351′ with the coding 350″ and the respective coding features 351′, respectively, the longitudinal extent of the radial protrusion 352″ is larger than the longitudinal extent of the protrusion 352′. Moreover, the longitudinal position of the radial protrusion 352″ is shifted towards the longitudinal end face 112 compared to the longitudinal position of the radial protrusion 352′.
The complementary-shaped counter codings 450, 450′, 450″ and the respective counter coding features 451, 451′, 451″ are subject to respective modifications.
With all examples the counter coding feature 451, 451′, 451″ comprises a coded groove 455 on the inside surface 203 of the receptacle 210. The coded groove 454 comprises a longitudinally extending first groove portion 455 and a circumferentially extending second groove portion 456 merging into the first groove portion 455. The first sections of the first groove portion 455 of the counter coding features 451, 451′, 451″ remain unamended are equal with all counter coding features 451, 451′, 451″.
The coding feature 451′ distinguishes from the coding feature 451 in that the longitudinal extent of the first groove portion 451 is larger. Moreover, the longitudinal extent of the first groove portion 455 of the counter coding feature 451″ of the third type is larger than the longitudinal extent of the first groove portion 455 of the counter coding feature 451′ of the second type.
The longitudinal width and hence the longitudinal extent of the second groove portion 456 varies with the counter coding features 451, 451′, 451″. The longitudinal width of the second groove portion 456 of the counter coding feature 451″ is larger than the longitudinal width of the second groove portion 456 of the counter coding feature 451′. The longitudinal width of the second groove portion 456 of the counter coding feature 451′ is larger than the longitudinal width of the second groove portion 456 of the counter coding feature 451. In this way it can be provided and ensured, that the coding 350 only and exclusively matches the counter coding or 450. It cannot engage or cooperate with any of the further counter codings 450′, 450″ or counter coding features 451′, 451″.
Likewise, the coding 350′ of the second type is incompatible with any of the mechanical counter coding 450 of the first type or the mechanical counter coding 450″ of the second type. The same is valid for the coding feature 350″ of the second type. The coding 350″ and the respective coding feature 351″ are incompatible with any of the counter coding 450 or counter coding feature 451 of the first type and are further incompatible with any of the counter coding 450′ or counter coding feature 451′ of the second type.
As further illustrated in
Accordingly, and when correctly assembled the visual indicator 358 is visible through the through recess 458 from outside the housing 10. Typically, the visual indicator 358 distinguishes from the visual appearance of the outside surface 105 of the insert 110 at least by its color, brightness and/or texture.
In a further example of
In principle, the fastening mechanism of the first housing component 100 and of the second housing component 200 is quite similar to the fastening mechanism as described above, e.g. in connection with any one of the
As illustrated the fastening element 520 is located longitudinally adjacent the radially outwardly extending flange section 115. Hence, the fastening element 520 as well as the visual indicators 558, 559 are provided at a distal end of the insert 110.
There is further provided a radial protrusion 130 on the outside surface 105 of the insert 110. The protrusion 130 is longitudinally aligned with the fastening element 520. It is located longitudinally offset from the fastening element 520. It may be arranged at the same longitudinal position as the mechanical coding 550 but it is located circumferentially offset from the mechanical coding 550.
The receptacle 210 of the second housing component 200 is separately illustrated in
Both grooves 624, 654 comprises a first longitudinally extending groove portion 625, 655 and a second groove portion 626, 656. The groove 654 is a coding groove or coded groove and is configured to operate or to engage with the coding feature 551. The groove 654 is part of a radial recess 652 of a counter coding feature 651 of the mechanical counter coding 650 is provided on the inside surface and 203 of the receptacle 210.
The groove 624 is configured to engage with the protrusion 130 and with the fastening element 520. The circumferential extent of the second groove portion 656 and of the second groove portion 626 is somewhat equivalent if not identical. This allows to perform the above-mentioned two-step assembly process. In a first step, the insert 110 is longitudinally inserted into the receptacle 210 without any rotation relative to the second housing component 200. Here, the protrusion 552 slides along the first groove portion 655 and the protrusion 130 as well as the protrusion 522 slide along the first groove portion 625. This insert motion in longitudinal direction may be blocked either when the flange section 115 abuts with the distal end face 214 of the receptacle 210 or when any one of the protrusions 130, 552 axially abuts with a longitudinal end of the first groove portion 625, 655.
Thereafter, the insert 110 can be subject to a rotation with regard to an axis of rotation extending parallel to an axis of symmetry of the first housing component 100 or second housing component 200. When in the intermediate assembly configuration, the visual indicator 258 may spatially overlap with a through recess 658 extending through the sidewall 202 of the receptacle 210 thereby indicating that the preassembly configuration has been reached.
Starting from the intermediate assembly configuration and by twisting the first housing component 100 relative to the second housing components 200 the protrusion 552 of the coding feature 551 slides along the second groove portion 656. The same applies to the protrusion 130. The protrusion 130 will slide along the circumferential extent of the second groove portion 626. The snap element 521 is located longitudinally offset from the second groove portion 626. When reaching the intermediate assembly configuration, the snap element 521 and its radially outwardly extending projection 522 is still located in the rather narrow portion of the first groove portion 625. Here, the side edge of the first groove portion 625 comprises a raised ridge 623, which exhibits a beveled side edge. Circumferentially offset from the ridge 623 there is provided a radial recess 622 which is sized and configured to positively engage with the projection 522 of the fastening element 520.
Contrary to the numerous examples as described above in connection with
This implementation provides the benefit, that the fastening element 520 and the complementary-shaped counter fastening element 620 can be longitudinally shifted in close vicinity to the flange section 115. Accordingly, the counter fastening element 620 can be arranged near the distal end face 214 of the receptacle 210, which may facilitate a releasable or detachable engagement of the first and second housing components 100, 200.
When reaching a final assembly configuration, the further visual indicator 559 will align and overlap with the through recess 658, thereby indicating, that a final assembly configuration has been reached. Since the second visual indicator 559 is visible through the through recess 658 from outside the housing 10 a respective visual feedback can be provided to the user. Typically, the visual indicator 558 and the visual indicator 559 mutually distinguish by at least one of a color, a brightness and/or texture. They are visually distinguishable.
The receptacle 210 as shown in
With the presently illustrated examples the insert 110 is provided on the first housing component 100 and the receptacle 210 is provided in the second housing component 200. There are numerous further examples conceivable and within the disclosure of the present application, wherein the insert is provided on the second housing component and wherein the correspondingly-shaped receptacle is provided on the first housing component. Likewise, the specific implementation of radially protruding and radially recessed features, as described in connection with the mechanical coding, the mechanical counter coding or as described in connection with the protrusion and the groove or in connection with the fastening element and counter fastening element may be interchanged provided and implemented in an inverted way compared to the presently shown examples.
| Number | Date | Country | Kind |
|---|---|---|---|
| 21315075.8 | May 2021 | EP | regional |
The present application is the national stage entry of International Patent Application No. PCT/EP2022/061645, filed on May 2, 2022, and claims priority to Application No. EP 21315075.8, filed on May 3, 2021, the disclosures of which are incorporated herein by reference.
| Filing Document | Filing Date | Country | Kind |
|---|---|---|---|
| PCT/EP2022/061645 | 5/2/2022 | WO |
