The present disclosure relates to the field of fluid dispensing devices and in particular to fluid dispensing devices configured as nasal inhalers. The disclosure further relates to spray devices configured to dispense a fluid or a liquid substance by way of spraying or atomizing. The disclosure also relates to a mechanical energy storage for use in a fluid dispensing device, e.g. for driving a discharge mechanism of the fluid dispensing device.
Fluid dispensing devices operable to atomize a liquid substance are as such known. Such devices typically comprise an outlet orifice, e.g. integrated in or provided by a nozzle. Upon application of a force by a user to an actuation lever or a button the fluid is dispensed via the outlet orifice. Such devices may be arranged to dispense a single or multiple doses and may be equipped with a container providing a reservoir for the fluid thus allowing and supporting the dispensing of several doses.
Such fluid dispensing devices may be provided with a mechanical energy storage operable to provide a force effect for discharging and/or atomizing of the fluid. Here, a user may induce a spray dispensing of the fluid by depressing a trigger by way of which mechanical energy provided by the mechanical energy storage is released for the fluid dispensing.
Charging or preloading of the mechanical energy storage may be induced by user interaction. With existing fluid dispensing devices a user has to recharge or preload the mechanical energy storage every time a fluid dispensing action has been triggered.
It is particularly desirable to provide an improved way of how to bias or to recharge a mechanical energy storage of such fluid dispensing devices. It is a particular aim to improve general handling of the device and user acceptance for such devices.
It is generally desirable to improve operability and user handling of such fluid dispensing devices.
In one aspect there is provided a fluid dispensing device. The fluid dispensing device e.g. implemented as a nasal inhaler comprises a housing. The housing is sized to accommodate a container filled with a fluid. The housing comprises a sidewall extending along a longitudinal direction (z). The fluid dispensing device further comprises an outlet orifice and a discharge mechanism. The discharge mechanism is operable for spray discharging at least one or multiple doses of the fluid via the outlet orifice. The fluid dispensing device also comprises a protective cap. The protective cap is pivotally supported on or by the housing between an open position and a closed position. When in the closed position the outlet orifice is effectively covered or enclosed by the protective cap.
The fluid dispensing device further comprises a mechanical energy storage coupled to the discharge mechanism. The mechanical energy storage is reversibly transferable between a preloaded state and an unloaded state. The mechanical energy storage is configured to store mechanical energy in the preloaded state, wherein the stored mechanical energy is effective to produce a spray discharging of the fluid, e.g. via the outlet orifice. The fluid dispensing device further comprises a biasing mechanism comprising a biasing member. The biasing member is operationally coupled to the protective cap and is selectively engageable with the mechanical energy storage to transfer the mechanical energy storage into the preloaded state when the protective cap moves into the closed position.
The fluid dispensing device further comprises a pinion segment connected to or integrated into the protective cap and further comprises a rack segment engaged with the pinion segment and connected to or integrated into the biasing member. The pinion segment typically mates with the rack segment. The rack segment may be of rather elongated shape. As the pinion segment is subject to a pivoting or rotating motion the rack segment may be subject to a longitudinal or translational motion relative to the housing thereby longitudinally displacing the biasing member towards and/or into a position, in which the mechanical energy storage assumes the preloaded state.
A pinion segment engaged with a rack segment provides a rather easy and elegant approach of how to transfer a pivoting motion of the protective cap into a reloading or biasing of a mechanical energy storage of the fluid dispensing device. The mutual engagement of the pinion segment and the rack segment can be provided at or near a hinged attachment of the protective cap to the housing of the fluid dispensing device. Moreover, by the pinion segment in e.g. permanent engagement with the rack segment the entirety of a pivoting motion of the protective cap when moved from the open position towards and into the closed position can be used to transfer mechanical energy into the mechanical energy storage. Mechanical backlash and/or a no load operation or movement of the protective cap can be reduced to a minimum.
With some examples the fluid dispensing device is implemented as a nasal inhaler. The outlet orifice may be provided on or integrated into a nozzle. The outlet orifice may be provided at a free end or distal end of a tapered nozzle. Such a nozzle may be configured and shaped for insertion into a nostril of a user.
Generally and as used herein, a preloaded state is a state, in which the mechanical engineering storage stores at least a non-zero portion of mechanical energy. Insofar the preloaded state is a loaded state. The term “preloaded” as used herein may further indicate and/or imply, that the fluid dispensing device can be stored in a loaded state, e.g. over a comparatively long time interval. Then and while not in use the fluid dispensing device is and remains mechanically biased and is immediately ready to use for discharging a dose of the fluid. Typically, preloading of the mechanical energy storage may be provided at the end of a dose dispensing procedure.
According to a further example the protective cap is connected and/or fixed to the housing by a hinge. The protective cap is pivotable relative to the housing with regards to a hinge axis of the hinge. The hinge provides a rather elegant and user-friendly approach of how to permanently connect a protective cap to the housing of a fluid dispensing device. For using of the fluid dispensing device and in order to reveal the outlet orifice the protective cap has to be pivoted into the open position. When in the open position the outlet orifice is accessible for discharging a dose of the fluid.
After use the protective cap can be easily pivoted into the closed position, thereby biasing the mechanical energy storage with mechanical energy, which is branched off from a user-induced pivoting motion of the protective cap. Insofar, the biasing mechanism is rather elegantly integrated into the protective cap. Providing of a separate biasing component can be therefore avoided and the total number of components the fluid dispensing device is made of can be reduced to a minimum.
According to a further example a radial center of the pinion segment coincides with the hinge axis. In this way, a radial position of a particular portion of the pinion segment that is in engagement with the rack segment of the biasing member remains substantially constant as the pinion segment and/or the protective cap is subject to a pivoting motion with the hinge axis as an axis of rotation. In this way a pivoting motion of the pinion segment and/or a pivoting motion of the protective cap can be transferred into a longitudinal and/or straight forward displacement or movement of the rack segment and hence of the biasing member relative to the housing. This way, the mechanical energy storage, which requires a longitudinal displacement of e.g. a driver along a longitudinal direction, can be easily provided with the biasing member urged in longitudinal direction through the pivoting motion of the pinion segment in engagement with the rack segment as the protective cap is subject to a pivoting movement towards the closed position.
According to a further example the discharge mechanism comprises a driver operatively coupled to the mechanical energy storage and movable relative to one of the container and the outlet orifice to effectuate the spray discharging of the fluid. The driver is longitudinally slidably guided in or on the housing along the longitudinal direction between a biased position and an unbiased position. Typically, the driver may be reversibly movable between a biased position and an unbiased position. When the driver is in the biased position the mechanical energy storage is in the preloaded state. When the driver is in the unbiased position the mechanical energy storage is in the unloaded state. Typically, the driver is movable from the unbiased position towards and into the biased position through movement of the biasing member operably coupled with the driver.
This way, the driver is configured to urge and/or to transfer the mechanical energy storage into the preloaded state. An oppositely directed movement of the driver is induced by the mechanical energy storage, namely when mechanical energy is released, e.g. stepwise from the mechanical energy storage. Such a movement of the driver as induced by mechanical energy released from the mechanical energy storage serves to effectuate the spray discharging of the fluid through the discharge mechanism.
According to a further example one of the container and the outlet orifice is connected to, fixed to, or is integrally formed with the housing. This way, the driver is movable relative to the housing for discharging a dose of the fluid as well as for transferring mechanical energy into the mechanical energy storage.
According to a further example the driver is mechanically coupled or is mechanically connected to the mechanical energy storage. The driver may be even integrated into the mechanical energy storage. The mechanical energy storage is transferable into the preloaded state upon moving the driver into the biased position relative to the housing. Transferring and/or moving the driver into the biased position relative to the housing is typically effectuated or provided by the biasing member being mechanically engaged with the driver.
With some examples the biasing member is in longitudinal mechanical abutment with the driver so as to urge the driver in the longitudinal direction in order to reach the biasing position.
According to a further example the driver is in longitudinal abutment with a first longitudinal end of a drive spring of the mechanical energy storage. Here, the housing is in abutment with a second longitudinal end of the drive spring. Accordingly, the driver is movable in longitudinal direction relative to the housing under the action of the drive spring or against the action of the drive spring. Typically, the driver is movable towards the biased position by mechanically deforming the drive spring so that the drive spring stores mechanical energy. Vice versa, the driver is movable towards the unbiased position under the effect of the drive spring, namely when mechanical energy stored by the drive spring is released.
According to a further example the sidewall of the housing of the fluid dispensing device comprises at least a first and a second longitudinally extending guiding rib on an inside surface slidably engaged with at least a first and a second complementary shaped guiding extending outwardly from a sidewall of the driver. With some examples the first and the second longitudinally extending guiding ribs are separated along a first transverse direction (y), e.g. perpendicular to the longitudinal direction (z).
This way, there is provided a twofold longitudinal guiding for the driver inside the housing of the fluid dispensing device. An at least twofold longitudinal guiding for the driver provides a rather tilt- and/or cant-free longitudinal sliding of the driver inside the housing. This supports a rather smooth and low friction sliding motion of the driver relative to the housing.
With some examples there may be provided even three, four or even more longitudinally extending guiding ribs on the inside surface of the housing slidably engaged with a respective number of three, four or even more complementary shaped guiding protrusions extending outwardly from a sidewall of the driver. This way, an even more stable and tilt-free guiding or sliding support can be provided for the driver relative to the housing.
By providing first and second inwardly protruding longitudinally extending guiding ribs in sliding engagement with complementary-shaped guiding protrusions protruding outwardly from a sidewall of the driver, mechanical friction for a sliding and/or a guided movement of the driver inside or relative to the housing can be reduced to a minimum. The guiding protrusions of the driver may comprise a rather limited longitudinal size. They may be provided in form of guiding pins or guiding studs that are only punctually in mechanical sliding engagement with the longitudinally extending guiding ribs as provided on the inside of the sidewall of the housing.
With another alternative example it may be outside surface or sidewall of the driver that is provided with at least first and second longitudinally extending guiding ribs whereas there are provided comparatively short, pin- or stud-shaped complementary shaped gliding protrusions extending inwardly from an inside surface of the sidewall of the housing.
According to a further example the at least first and second complementary shaped guiding protrusions are located near a proximal longitudinal end of the driver. The biasing member of the biasing mechanism may be configured to engage or to abut a longitudinally oppositely located end of the driver. With some examples the biasing member of the biasing mechanism may be shaped and configured to engage with a distal end of the driver. With further examples the biasing member of the biasing mechanism is implemented to abut or to engage only one side of the driver as seen along a second transverse direction.
Insofar, the biasing mechanism may be limited to apply a biasing force onto the driver rather asymmetrically. By providing at least first and second guiding structures and/or guiding protrusions on the driver separated along the second transverse direction (x) such an asymmetric force effect can be effectively equalized or compensated thereby supporting and allowing a rather smooth and easy sliding or gliding of the driver relative to the housing.
According to a further example the driver comprises a hollow interior sized to receive the container. The driver may comprise or provide an inner housing sized to receive the entirety of the container. The driver may form or constitute a kind of a chassis movably disposed inside the housing of the fluid dispensing device. This way, the driver may provide a longitudinal displacement of the container relative to the outlet orifice, when the outlet orifice is fixed to the housing of the fluid dispensing device.
By moving the container relative to the outlet orifice e.g. towards a proximal longitudinal direction, a well-defined amount of the fluid may be withdrawn from the interior of the container. By moving the driver in distal direction relative to the housing the amount of the fluid previously withdrawn from the interior of the container can be dispensed via the outlet orifice. It may be expelled from a dispensing chamber of the discharge mechanism.
According to a further example the biasing member comprises at least a first abutment face to abut in longitudinal direction with a complementary-shaped first counter abutment face of the driver. The first abutment face of the biasing member gets in direct contact with the first counter abutment face of the driver when the biasing member is moved towards the driver in the course of a closing motion of the protective cap. Typically and when the protective cap is closed, the biasing member is moved in longitudinal proximal direction. Then, the abutment face is or gets in direct abutment with the first counter abutment face of the driver and serves to move or to urge the driver into the biased position, thereby transferring the mechanical energy storage into the preloaded state.
Accordingly, and with another example the biasing member is longitudinally guided in or on the housing along the longitudinal direction between a distal end position and a proximal end position. The biasing member is movable from the distal end position towards and into the proximal end position through a pivoting motion of the protective cap from the open position towards and into the closed position, typically by the pinion segment engaged with the rack segment.
This movement of the biasing member towards the proximal end position is transferable onto the driver by the mutual abutment of the first abutment face of the biasing member with the complementary-shaped first counter abutment face of the driver. The motion of the driver in proximal direction is typically directed against the action of the drive spring of the mechanical energy storage. This way, mechanical energy can be provided to the mechanical energy storage, which by way of an interaction with a releasable interlock is effectively stored in the mechanical energy storage until a trigger mechanism operationally engageable with the interlock is activated by a user in order to release at least a portion of the mechanical energy of the mechanical energy storage.
According to a further example the at least one abutment face faces in the proximal direction along which the biasing member is movable from the distal end position towards and into the proximal end position. Here, the proximal direction is also the direction along which the driver is movable into the biased position.
When the protective cap is transferred from the closed position into the open position the releasable interlock is configured to retain the mechanical energy storage in the preloaded state. Then, the biasing member, which is permanently in mechanical engagement with the protective cap via the pinion segment mating with the rack segment, is separated from the driver towards the distal direction. Upon release of mechanical energy from the mechanical energy storage, e.g. through a single or repeated actuation of a trigger the drivers is subject to a distally directed motion relative to the housing until it may re-engage, e.g. re-abut with the biasing member. Closing of the protective cap may again move the biasing member towards the proximal direction, thereby slaving or pushing the driver accordingly towards and into the biased position.
According to a further example the biasing member comprises a first side wall section, a second sidewall section and a third sidewall section. The first and third side wall sections extend substantially parallel to each other. The first and the third side wall sections are interconnected by the second side wall section extending therebetween.
The rack portion is provided on an outside facing surface of the second side wall section. It is typically provided on that portion of the second sidewall section that faces away from an interior free space confined by the first and third side wall sections. Typically, the first abutment face is provided on a longitudinal end of at least one of the first and the third side wall sections. Preferably, the first sidewall section comprises a first abutment face and the third side wall section comprises a complementary or correspondingly shaped second abutment face.
The first and the second abutment faces are configured to simultaneously engage complementary shaped first and third counter abutment faces of the driver. In this way, a force effective to move the biasing member towards the proximal direction can be distributed across the first and third sidewall sections and can be rather symmetrically introduced into or transferred to the driver.
As seen in a plane perpendicular to the longitudinal direction, the first, the second and the third side wall sections form conform a U-shaped geometry or transverse cross section, wherein the first and third sidewall sections extend in a plane as defined by the longitudinal direction (z) and the second transverse direction (x) and wherein the second sidewall section is extending in a plane as defined by the longitudinal direction (z) and the first transverse direction (y).
According to a further example the first abutment face is provided at a proximally facing edge of a lateral protrusion of the first sidewall section. The second abutment face is provided at a proximally facing edge of a lateral protrusion of the third side wall section. The driver typically comprises a second complementary shaped counter abutment face to engage with the second abutment face of the third side wall section of the biasing member. This way, there can be provided an at least twofold longitudinal abutment between the biasing member and the driver so as to provide a rather tilt-free and/or cant-free sliding displacement of the driver under the effect of the biasing member moving towards the proximal direction as the protective cap is subject to a pivoting motion towards the closed position.
With a further example of the fluid dispensing device the driver comprises a sidewall section with a longitudinally extending recess adjoining a distal end of the driver. The longitudinal extending recess is shaped to slidably receive the lateral protrusion of the first side wall section of the biasing member. With some examples, wherein the biasing member comprises a first and a second abutment face also the driver comprises a further longitudinally extending recess on another sidewall section, which is typically located opposite to the above-mentioned side wall section. The another sidewall section comprises another longitudinal recess adjoining the distal end of the driver and being shaped to slidably receive the lateral protrusion of the third sidewall section of the biasing member.
Providing of (a) longitudinally extending recess(es) on the driver provides a rather compact and space saving arrangement of the biasing member and the driver. Moreover, the biasing member and the driver can be arranged in a somewhat overlapping or nested manner. This way, the biasing member may be at least partially guided or mechanically stabilized by the driver.
Moreover, the second sidewall section of the biasing member may comprise an extension along the first transverse direction that substantially matches the respective extension of the driver in this direction. This way, the first and the third sidewall sections with their lateral protrusions may be located on oppositely located outside surfaces of the driver facing in the first transverse direction. This way, the first and third sidewall sections of the biasing member with the respective lateral protrusions may at least partially enclosed a border or edge section of the driver located in close vicinity to the hinge of the protective cap.
According to a further example the longitudinal recesses as provided on the sidewall section(s) of the driver is/are delimited towards a longitudinal proximal direction by the counter abutment face as mentioned above. Hence, the first and/or the second sidewall sections of the biasing member may slidably engage the longitudinal recess on the outside surface of oppositely located side wall sections of the driver. Since the longitudinal recesses are delimited towards the longitudinal proximal direction the lateral protrusions provided with the proximally facing abutment faces may engage the counter abutment faces at the proximal end of the longitudinal recesses of the driver thereby urging or pushing the driver in the proximal direction and hence towards the biased position as the protective cap is subject to a closing pivoting motion.
According to a further example the biasing member comprises at least one of a longitudinal extending rib and a longitudinally extending notch on an outside surface slidably engaged with a complementary shaped elongated notch or rib provided on an inside of the sidewall of the housing. This way the biasing member itself is longitudinally slidably engaged with the housing and can be moved in longitudinal proximal and distal direction as the protective cap is opened and closed.
The longitudinally extending rib or notch on the outside surface of the biasing member engaged with a complementary-shaped elongated notch of rib on the inside of the sidewall of the housing provides a smooth and precise longitudinally guided sliding motion of the biasing member relative to the housing.
Typically, opposite side walls of the biasing member each comprise at least one of a longitudinally extending rib at a longitudinal extending notch on their outside surface slidably engaged with a complementary-shaped elongated notch on each of the oppositely located inside surfaces of the sidewall of the housing. In this way, an at least twofold longitudinally guided sliding motion of the biasing member relative to the housing can be provided. Here, the biasing member is rather safely longitudinal guided in or by the housing and serves to exert a longitudinally directed force effect onto the driver as the protective cap is subject to a pivoting motion.
According to a further example the fluid dispensing device is equipped with the container, which is filled with the fluid. The container is connected to the outlet orifice in a fluid transferring manner. Typically, the fluid dispensing device may comprise a pump or spray delivery mechanism by way of which the fluid located in the container can be withdrawn from the container and can be stored or accommodated in a dispensing chamber of a dispensing or discharge mechanism.
With some examples the container may be releasably attachable to the discharge mechanism. The container may be arranged in a removable manner inside the housing of the fluid dispensing device. Hence, the fluid dispensing device may be implemented as a reusable device offering to replace the container when empty. With other examples the fluid dispensing device is implemented as a disposable device. Here, the container filled with the fluid may be permanently located inside the housing of the fluid dispensing device. Then, the container may not be exchangeable arranged inside the housing. When the container is empty the entire fluid dispensing device may be intended to become discarded.
With some examples the mechanical energy storage comprises at least a first drive spring which is resiliently compressible in the longitudinal direction (z) to store mechanical energy. The drive spring is operable to induce a longitudinal motion of the driver when the interlock is released by actuation of the trigger. With some examples the mechanical energy storage comprises a first drive spring and a second drive spring. The first and the second drive springs may be oriented parallel to each other and may be arranged on opposite sides of the driver. This way, a rather smooth and tilt free longitudinal sliding displacement of the driver relative to the housing can be provided.
Generally, the scope of the present disclosure is defined by the content of the claims. The fluid dispensing 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 fluid dispensing device that faces towards an application site of a person or of an animal. The term ‘proximal’ or ‘proximal end’ relates to an opposite end of the application device, which is furthest away from an injection site of a person or of an animal.
The terms “fluid”, “drug” or “medicament” are used synonymously herein and may describe at least one of a consumer health care product and 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. A consumer health care product may be void of an active pharmaceutical ingredient. It may be commercially available free of prescription. As a nonlimiting examples consumer health care products may include products such as nasal sprays, cough syrups, eyedrops, creams, ointments, dietary and nutrition supplements and/or cosmetics.
As described below, a fluid, 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, alternatively 1 to at least 10, 15, 20, or 25 days). In some instances, the chamber may be designed to store a drug for about 1 month to about 2 years, alternatively from about 1 month to about 6 months, alternatively from about 1 month to about a year, alternatively from about 1 month to 1.5 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 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. 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.
The details of particular implementations are set forth in the accompanying drawings and description below. Like reference numerals may refer to like elements throughout the specification. Other features will be apparent from the following description, including the drawings and claims. The drawings, though, are for the purposes of illustration and description only and are not intended as a definition of the limits of the disclosure.
In the following, numerous examples of a fluid dispensing device will be described in greater detail by making reference to the drawings, in which:
In
The fluid container 110 may be entirely arranged inside the hollow and rather cup-shaped body 11 of the housing 10. The housing 10 further comprises a protective cap 12. The protective cap 12 is sized and shaped to enclose an outlet orifice 3, e.g. provided at or in a nozzle 14. The nozzle 14 may comprise a conically-shaped protrusion sized for insertion into a nostril of a user. A distal end of the nozzle 14 may be provided with the outlet orifice 3. The outlet orifice 3 may be part of an atomizer 2 configured and shaped to atomize or to nebulize the fluid when dispensed by or through the nozzle 14.
The nozzle 14 may be implemented as a part of a closure 13 configured for fastening to a distal end of the cup-shaped body 11. The closure 13 may be clip-fastened to the upper or distal end of the body 11. The closure 13 may be detachably or undetachably connected to the sidewall 18 of the body 11.
The protective cap 12 is pivotally supported or arranged on the housing 11. It may be hingedly attached to the housing 11 by way of a hinge 20. For this, the protective cap 12 comprises a hinge axis 21. The housing 11 comprises two oppositely located recesses 22 sized and shaped to receive an axial protrusion 152 of a pinion segment 151 integrally formed or attached to the protective cap 12 as illustrated in
The axial protrusions 152 may be snap fitted into the oppositely located recesses 22 and may be pivotally supported in the recesses 22 on the inside surface of the sidewall 18. This way, the protective cap 12 can be pivoted relative to the body 11 between a closed position as illustrated in
Inside the fluid dispensing device 1 there is provided a driver 30, which is longitudinally displaceable relative to the housing 10 along a longitudinal direction (z). The driver 30 is implemented as a part of a discharge mechanism 130. The discharge mechanism 130 comprises or forms a pump by way of which one or several doses of the fluid can be extracted or withdrawn from the fluid container 110 and by way of which one or multiple doses of the fluid can be expelled through the nozzle 14 by one or several spray delivery actions.
The driver 30 and hence the discharge mechanism 130 is biased by a mechanical energy storage 50. The mechanical energy storage 50 comprises at least one drive spring 51, 52 by way of which mechanical energy can be stored in the fluid dispensing device 1. The mechanical energy storage 50 is operatively coupled or engaged with the discharge mechanism 130 and is transferable between a preloaded state and an unloaded state. The mechanical energy storage 50 is configured to store mechanical energy in the preloaded state, which mechanical energy is effective and sufficient to produce the spray discharging of the fluid.
The fluid dispensing device 1 further comprises a releasable interlock 70, which is configured to retain the mechanical energy storage 50 in the preloaded state. The fluid dispensing device 1 further comprises a trigger mechanism 90 operably engageable or operably engaged with the interlock 70. When engaged with the trigger mechanism 90 the interlock is operable to release at least a first portion of the mechanical energy stored in the mechanical energy storage when actuated for a first time. The trigger mechanism 90 is further operable to release at least a second portion of the mechanical energy stored in the mechanical energy storage 50 when actuated for a second time.
In other words, the mechanical energy storage 50, the releasable interlock 70 and the trigger mechanism 90 are configured to provide numerous, i.e. at least a first and a second spray delivery or spray discharging of the fluid upon repeated actuation of the trigger mechanism without an intermediate preloading or re-charging of the mechanical energy storage 50.
As will be described below in greater detail the mechanical energy storage 50 can be preloaded or charged by transferring the protective cap 12 from the open position as illustrated in
With the presently illustrated example it is intended that the mechanical energy storage 50 is preloaded or charged with mechanical energy upon and by transferring the protective cap 12 from the open position into the closed position. This way it can be ensured, that the mechanical energy storage is sufficiently charged or preloaded since the closing action of the protective cap 12 is easily controllable by the end user and is inherently provided with a mechanical, haptic, and e.g. audible feedback, e.g. when a snap feature 5 as provided on one of the body 11 or a closure 13 engages with a complementary shaped counter snap feature 7 as provided on the protective cap 12.
Dispensing of a dose of the fluid contained inside the fluid container 110 is provided by moving the driver 30 relative to the nozzle 14. Since the nozzle 14 is rigidly connected or fixed to the body 11 delivery or dispensing of a dose of the fluid is also provided by moving the driver 30 relative to the housing 10 or relative to the body 11 along the longitudinal direction (z).
With the presently illustrated example a dose of the fluid is dispensed by moving the driver 30 relative to the housing 10 in longitudinal distal direction, hence towards the nozzle 14. The driver 30 is part of a discharge mechanism 130. The discharge mechanism 130 comprises a kind of a pump mechanism. The discharge mechanism 130 comprises an inlet valve 131 and an outlet valve 141 as illustrated in
The dispensing chamber 140 comprises a tubular sidewall 142 provided inside the nozzle 14 as illustrated in the sequence of
An outside surface of the inner tubular section 134 is sealed by a tubular sheath 138 of a flexible material. The tubular sheath 138 may comprise a polymeric or elastomeric material being elastically deformable. The inner tubular section 134 and hence its hollow interior is confined in distal direction by a closed end face 137. At a predefined distance from the distal end face 137 the sidewall 135 comprises at least one through opening 136. The through opening 136 or several through openings is/are a radially covered and sealed by the tubular sheath 138. A distal end face 139 of the tubular sheath 138 is flush with a respective outer end face of the inner tubular section 134.
Towards a proximal end, the dispensing chamber 140 is sealingly engaged with an outside surface of the tubular sheath 138. Here, an inside surface of the sidewall 142 is provided with a sealing lip 6. The sealing lip 6 may comprise an annular protrusion and may be in fluid-tight but longitudinally smoothly movable engagement with the outside surface of the tubular sheath 138. The tubular sheath 138 is tightly fitted to the outside surface of the inner tubular section 134. In situations, wherein a fluid pressure inside the dispensing chamber 140 is lower than a fluid pressure inside the inner tubular section 134 the fluid provided inside the hollow part of the inner tubular section 134 is sucked or drawn into the dispensing chamber 140.
Here, a pressure gradient between the dispensing chamber 140 and the hollow interior of the inner tubular section 134 serves to urge the fluid through the at least one through opening 136 into a slot or gap formed between the inside surface of the tubular sheath 138 and the outside surface of the inner tubular section 134. Due to the pressure gradient the distal end of the tubular sheath 138 may widen in radial direction so as to form a respective slot, gap or slit and to enable a transfer of the fluid from the interior of the inner tubular section 134 into the dispensing chamber 140.
The distal end of the dispensing chamber 140 is sealed by the outlet valve 141. The outlet valve 141 and the inlet valve 131 are implemented in a technically similar or substantially identical manner. The outlet valve 141 comprises a tubular section 144 with a hollow interior in permanent fluid contact with the dispensing chamber 140. The tubular section 144 may extend distally from the dispensing chamber 140. The tubular section 144 may be stepped down in radial direction compared to the geometry or diameter of the dispensing chamber 140.
Towards the distal end the tubular section 144, hence the sidewall 145 of the outlet valve 141 is confined in distal direction by a closed end face 147. The sidewall 145 also comprises a through opening 146 or several through openings 146 near the distal end face 147. An outside surface of the sidewall 145 is also tightly engaged with another tubular sheath 148, which is elastically deformable at least in radial direction. As soon as a pressure inside the tubular section 144 is larger than a pressure outside the outlet the fluid provided in the dispensing chamber 140 will be urged through the through opening(s) 146 into a gap or a slit provided between the outside surface of the sidewall 146 and an inside surface of the radially widened tubular sheath 148 of elastic material.
This way, the fluid may flow into and through the atomizer 2 enclosing the distal end of the outlet valve 141 . . . . With the presently illustrated example the atomizer 2 is rigidly fastened, e.g. snap fitted on the distal end of the nozzle 14 and comprises the outlet orifice 3 located downstream and hence distally from the tubular section 144 of the outlet valve 141. Due to an increase of the fluid pressure inside the dispensing chamber 140 fluid is expelled through the hollow tubular section 144 of the outlet valve 141 through the at least one through opening 146, thereby radially widening the tubular sheath 148 so as to enter the orifice 3 by way of which the fluid expelled through the atomizer 2 is effectively atomized or nebulized.
With other examples (not illustrated) the outlet orifice 3 is in fluid connection with the dispensing chamber 140 and/or with the outlet valve 144 and is void of an atomizer 2. Here, the fluid dispensing device 1 may be configured to dispense other types of fluids, e.g. highly viscous fluids, such as syrups, that do not require to be atomized or nebulized. The outlet orifice 3 may be also configured to produce single or multiple drops or droplets of the fluid in a dispensing action. Generally, the outlet orifice 3 may be arranged the housing 10 or may be integrated into the housing 10 without a nozzle 14.
The dispensing chamber 140 can be filled with the fluid by moving the inlet valve 131 in proximal direction relative to the nozzle 14, which is downwardly in the illustration of
Accordingly, and due to the pressure gradient, the fluid will then start to flow through the at least one or several through openings 136, thereby slightly radially outwardly widening the tubular sheath 138. This way, the dispensing chamber 140 will the filled with the fluid.
For dispensing a dose of the fluid by the outlet valve 141 it is intended to longitudinally displace the inlet valve 131 in distal direction towards the outlet valve 141. This way, the volume of the dispensing chamber 140 is reduced and the fluid pressure inside the dispensing chamber 140 will raise. When the inside pressure of the dispensing chamber 140 is larger than an inherent resistance of the outlet valve 141 the rising fluid pressure will be effective to urge the fluid through the through opening(s) 146, thereby radially widening the tubular sheath 148 and expelling the fluid through the atomizer 2. In the sequence of
In
When the trigger mechanism 90 is actuated a second time, the driver 30 and the inlet valve 131 are subject to a further distally directed discrete movement, thus leading to a further reduction of the volume or size of the dispensing chamber 140″ as illustrated in
Moving of the inlet valve 131 and hence moving of the driver 30 towards a proximal direction is effective and configured to fill the dispensing chamber 140 with the fluid. Here, a respective amount of the fluid is withdrawn from the interior of the fluid container 110 by way of suction. For dispensing multiple doses or strokes the driver 30 and hence the inlet valve 131 is moved in numerous discrete steps in longitudinal distal direction relative to the outlet valve 141 as illustrated by the sequence of
The driver 30 is slidably displaced with regard to the longitudinal direction inside the body 11. The driver 30 is movable in longitudinal direction under the effect of the mechanical energy storage 50. The driver 30 is also operable to bias or to preload the mechanical energy storage 50. The driver 30 is longitudinally slidably guided in the housing 10 between a biased position as illustrated in
The driver 30 is displaceable towards the biased position, hence towards the proximal direction against the action of the mechanical energy storage 50. The driver 30 is movable in the opposite direction under the action of the mechanical energy storage. When the mechanical energy storage 50 releases mechanical energy this mechanical energy is operable to urge or to move the driver 30 in distal direction so as to effectuate a spray discharging by moving the inlet valve 131 relative to the outlet valve 141 as described above.
The driver as illustrated in
With the presently illustrated examples there are provided four outwardly extending guiding protrusions 49 on the outside surface of the sidewall 18 of the driver 30. This way, there can be provided a rather tilt-free and/or cant-free and hence rather smooth longitudinal guiding of the driver 30 inside the body 11 of the housing 10. The driver 30 is movably and slidably displaceable between the unbiased position as illustrated in
The mechanical energy storage 50 comprises a first drive spring 51 and a second drive spring 52. The first drive spring 51 and the second drive spring 52 are provided on opposite side edges of the driver 30. The driver 30 comprises a continues cross sectional profile extending in the longitudinal direction (z). The driver 30 and hence the carrier 31 comprises a sidewall 32 extending in longitudinal direction and comprises a somewhat rectangular shaped cross-section. A long side of the sidewall extends along a second transverse direction (x) and a short side of the sidewall extends along a first transverse direction (y).
The first and the second drive springs 51 are provided on the opposite side of the sidewall 32 of the driver 30 that are separated along the second direction (x). Towards or near the distal end 33 the driver 30 comprises an abutment 35 with a V-shaped recess 36. A distal end of the recess 36 forms a proximally facing abutment 35 for a respective distally located longitudinal end 53 of the drive spring 51, 52. In the opposite direction and hence towards the distal end the drive springs 51, 52 each comprise a proximal longitudinal end 54 that is in abutment with a distally facing abutment 15 provided at a respective V-shaped recess 16 on the inside surface of the body 11 as indicated in
Hence, the driver 30 comprises a driver abutment 35 to engage with the first longitudinal end 53 of the first drive spring 51 and/or of the second drive spring 52. The housing 10 comprises a housing abutment 15 to engage with the second longitudinal end 34 of the drive spring(s) 51, 52.
The mechanical energy storage 50 is reversibly transferable into a preloaded state by resiliently compressing the drive spring(s) 51, 52 in the longitudinal direction. As illustrated in
This way, the drive spring 51, 52 are compressible into a S-shaped, double S-shaped or M-shaped deformed configuration. In order to induce a well-defined transverse deformation of the drive springs 51, 52 at least one of the driver 30 and the housing 10 comprises a spring fixing notch 65, 66 through which the longitudinal extending slot profile of the drive spring 51, 52 is guided and/or fixed in longitudinal direction (z).
A free space of the spring fixing notch is 65, 66, through which the drive spring 51, 52 is longitudinally guided is only slightly larger than a thickness of the lateral profile of the drive spring 51, 56. Hence, in the region of the spring fixing notches 65, 66 the position of the drive spring 51, 52 is substantially fixed with regards to the first transverse direction (y).
The spring fixing notches 65, 66 are separated in longitudinal direction. This way, and when the oppositely located longitudinal ends 53, 54 of the drive spring(s) 51, 52 are subject to a compression in longitudinal direction (z) there will evolve oppositely directed arc-shaped undulations 57, 58, 59 extending in the first transverse direction (y). The undulations are provided by respective deformable portions 67, 68, 69 of the respective drive springs 51, 52.
As illustrated in
Between the second spring fixing notch 66 and the housing abutment 15 there is located a third bendable or deformable portion 69 of the drive spring 52. When subject to longitudinal compression the third bendable portion 69 also forms an arc-shaped undulation 59 extending in the same direction as the first undulation 57.
On the outside surface of the sidewall 32 of the driver 30 there are further provided spring deformation guiding elements 37, 38 and 39 that are located e.g. midway between adjacently arranged prefixing notches 65, 66 and between an upper or lower prefixing large and a respective abutment 15, 35 of the housing 10 and/or of the driver 30. A first spring deformation guiding element 37 is located longitudinally between the driver abutment 35 and the first prefixing notch 65. A second spring deformation guiding element 38 is located longitudinally between the first spring fixing notch 65 and the second spring fixing notch 66 and a third spring deformation guiding element 39 is located, e.g. longitudinally midway, between the second spring fixing notch 66 and the housing abutment 15.
Spring deformation guiding elements positioned adjacently in longitudinal direction (z) are located on opposite sides of the drive spring 51, 52 as seen with regards to the first transverse direction (y). The spring deformation guiding elements 37, 38, 39 are configured to induce a deformation of the first, second and third deformable or bendable portions 67, 68, 69 of the drive spring 51, 52 away from the respective spring deformation guiding element 37, 38, 39 into a respective arc-shaped undulation 57, 58, 59.
Insofar, the spring deformation guiding elements 37, 38, 39 are arranged and configured to break the longitudinal symmetry of the rather straight shaped elongated first and second drive springs 51, 52. A side edge of the spring deformation guiding elements, which protrude from the sidewall 32 of the driver 30 with regard to the second transverse direction (x) are arranged slightly offset from a virtual longitudinal center line of the first and second drive springs 51, 52 as seen in the first transverse direction (y).
This way, the drive springs 51, 52, which may be of substantially straight shape when in the completely unbiased position as illustrated in
By way of the V-shaped recesses 16, 36 as provided by the housing 10 and the driver 30, a rather precise abutment and alignment of the drive springs 51, 52 can be provided with regards to the first transverse direction (y). The V-shaped recesses 16, 36 provide a kind of a self-centered arrangement of the drive Springs 51, 52 with regard to the first transverse direction (y).
The drive springs 51, 52 as illustrated in
In effect, the longitudinally extending elongated and rather straight shaped drive springs 51, 52 are beneficial to provide a rather constant spring force in longitudinal direction (z) when subject to the deformation with regards to the first lateral direction (y). Rather independently of the degree of deformation in the first lateral direction (y) as illustrated in the various configurations of
The spring arrangement is further of particular benefit to provide a sequence of dispensing actions without an intermediate charging or reloading of the mechanical energy storage 50.
Hence, the mechanical energy stored by the drive springs 51, 52 and hence stored by the mechanical energy storage 50 can be released in a sequence of discrete steps, each of which releasing an amount of mechanical energy sufficient to effectuate a spray discharging of a dose of the fluid.
Apart from that, the longitudinal and rather elongated straight shape of the drive springs 51, 52 is beneficial with regards to a compact design of the mechanical energy storage 50. The drive springs 51, 52 only require a rather limited construction space.
In the example of
With the integrated drive spring assembly is also conceivable to implement a further spring element 73 into the drive spring assembly. The further spring 73 may belong to the releasable interlock 70 and may serve to keep a locking element 71, e.g. provided as a free end of the slab-like locking spring 73 in engagement with a complementary shaped counter locking structure 40 of the driver 30 as will be explained further below.
Here, all metal components of the fluid dispensing device 1 may be integrated in the drive spring assembly, thereby facilitating the mass manufacturing and assembly of individual parts of the fluid dispensing device 1. Also, the number of individual parts for assembly of the device 1 can be reduced.
As will be explained and described further below the locking element 71 of the interlock 70 is operable to retain the mechanical energy stored in the mechanical energy storage 50. The releasable interlock 70 is operably engaged with the trigger mechanism 90. Actuation of a trigger button 91 may at least temporally disengage the locking element 70 from the counter locking structure 40 and may thus allow to release at least a portion of the mechanical energy from the mechanical energy storage 50 in order to move the driver 30 towards the unbiased position, thereby dispensing a dose of the fluid.
In the illustration of
When the protective cap 12 is about to reach the closed position the abutment 8 gets in direct mechanical contact with the counter abutment 9. When reaching the closed position the abutment 8 is effective to press down onto the counter abutment 9 and to exert a respective proximally directed force effect onto the counter abutment 9, thereby inducing a further proximally directed movement of the driver 30 towards the proximal direction.
This leads to a kind of an over-pressing of the mechanical energy storage 50. As illustrated with this kind of a primed configuration as shown in
In
When the fastening structure 114 of the rigid fastening adapter 112 engages with the complementary or correspondingly shaped counter fastening structure 126 of the fluid dispensing device 1 there is provided a fluid-tight connection between the fluid discharge mechanism 130 of the dispensing device 1 and the outlet shaft 113 as provided by the rigid fastening adapter 112.
The flexible bag 120 provides a rather easy and smooth withdrawal of the fluid from the interior volume 123. When withdrawing a portion of the fluid from the interior volume 123, the flexible bag 120 may collapse due to the reduced interior volume 123. As indicated in
A collapsible sidewall 122 of the flexible bag 120 and hence a collapsible fluid-tight bag 120 allows and supports a suction-based withdrawal of the fluid from the interior volume 123.
The rigid fastening adapter 112 that is sealingly engaged with the bag outlet 124 provides a well-defined mechanical fastening of the fluid container 110 with the discharge mechanism 130.
As indicated in
With the example of
The fastening structure 114 and hence the beveled shaped snap element 116 may comprise an annular structure to engage with a complementary shaped annular structure of the counter snap element 128. In order to enable a rather smooth and easy mutual snap-fit engagement there may be provided at least one or several interruptions or recesses in the annular structure of at least one of the beveled shaped snap element 116 and the complementary shaped beveled counter snap element 128. As illustrated in the cross-section of
As particularly illustrated in
The outside surface of the tubular shaped valve insert 132 and the inside surface of the receptacle 117 of the outlet shaft 113 are configured such that a fluid tight engagement is provided between the bag outlet 124 and the hollow portion of the valve insert 132 as the fastening structure 114 engages with the complementary-shaped counter fastening structure 126.
With another example occurs in not illustrated it is also conceivable, that the inlet valve 131 comprises a hollow shaft with a receptacle configured for receiving and insertion of the outlet shaft 113 of the fluid container 110.
As further illustrated in
With the example of
With some examples the outer rigid casing 111 is made of a material or a material composition comprising at least one of a high-density polyethylene and a polypropylene. With some examples the outer rigid casing comprises a multilayer structure with a first layer made of a high-density polyethylene and a second layer made of a polypropylene. The lexical bag 120 may be blow molded or injection molded into the outer rigid casing 111. With other examples the flexible bag 120 and the outer rigid casing 111 co-extruded. Any of these manufacturing methods may have certain advantages for a cost efficient and reliable mass manufacturing of such fluid containers.
With the example of
The rigid fastening adapter 112, comprises the hollow outlet shaft 113 protruding outwardly from the interior volume 123 of the flexible bag 120. An inside facing side of the shoulder portion 115 is in a sealing engagement with the flexible sidewall 122. Here, the shoulder portion 115 comprises numerous snap elements 116 protruding outwardly in distal direction from the shoulder portion 115. Alternatively or additionally, there may be provided respective snap elements 116 at a lateral side edge of the shoulder portion 115. Towards the inside the shoulder portion 150 may comprise a comparatively short sidewall portion 119 extending in longitudinal direction, e.g. forming a circumferentially closed rim.
The sidewall portion 119 may be in abutment with the longitudinal, hence with the distal end of the sidewall 122 of the flexible bag 120. Here, an inside surface of the sidewall 122 may be sealingly engaged with an outside surface of the sidewall portion 119. Alternatively, an outside surface of the sidewall is sealingly engaged with an inside surface of the sidewall portion 119.
Optionally, the fastening adapter 112 and hence the rather planar-shaped shoulder portion 115 may be connected with a cup-shaped rigid casing 111 as illustrated in the cross-section of
Even though not particularly shown, also here the sidewall 120 may comprise a bag outlet 124 comprising a diameter that is smaller than the diameter of the sidewall 122 near a proximal end or in a longitudinal middle portion of the sidewall 122. Also here, and as illustrated in the example of
Charging and/or preloading of the mechanical energy storage 50 is described below in further detail. For biasing or charging of the mechanical energy storage 50, there is provided a biasing mechanism 150 comprising a biasing member 160 as shown in
The biasing mechanism 150 with the biasing member 160 comprises a pinion segment 151 connection to or integrated into the protective cap 12. The biasing member 160 further comprises a rack segment 161 with numerous teeth engaged with the pinion segment 151, e.g. engaged with the teeth of the pinion segment. As illustrated in greater detail in
The rack segment 161 comprises numerous teeth that are arranged next to each other along the longitudinal direction (z). The rack segment 161 is of rather elongated shape and extends along the longitudinal direction. As the protective cap 12 is subject to a pivoting motion relative to the housing 10 the teeth of the pinion segment 151 successively engage with the teeth of the rack segment 161, thereby inducing a longitudinal sliding motion of the rack segment 161 and hence of the biasing member 160 relative to the housing 10 and relative to the body 11. The biasing member 160 comprises a somewhat U-shaped profile as seen in the transverse cross-section.
The biasing member 160 comprises a first sidewall section 162, a second side wall section 163 and a third sidewall section 164, wherein the first and the third sidewall sections 162, 164 extend substantially parallel to each other. They are separated with regards to the first transverse direction (y). The second sidewall section 163 extends between the first and the third side wall sections 162, 164. The numerous sidewall sections 162, 163, 164 are integrally formed. Hence, the biasing member 160 is implemented as a single piece.
On the outside surfaces of the first and the third sidewall sections 162, 164 there are provided longitudinal extending guiding ribs 165, 166 to engage with complementary shaped guiding ribs 24, 25 as provided on an inside surface of the sidewall 18 of the body 11. This way, the biasing member 160 is longitudinally guided in the body 11 of the housing 10. By way of a pair wise mutual engagement of guiding ribs 166, 25 and guiding ribs 165, 24 a rather smooth, tilt-free and/or cant-free longitudinal sliding displacement of the biasing member 160 relative to the body 11 can be provided.
The first sidewall section 162 further comprises a lateral protrusion 167 extending and protruding along the second lateral direction (x) from a lower portion of the second sidewall 162. The lateral protrusion 167 lies in the plane of the second sidewall section and forms an abutment face 169 facing in proximal direction. The abutment face 169 is formed by a lower edge of the lateral protrusion 167 and is complementary shaped to a counter stop face or counter abutment face 29 of the driver 30. Here, the driver 30 comprises a longitudinally recess 27 adjoining a distal end 33 of the side wall of the driver 30. The longitudinally extending recess 27 is provided in an outside section of the sidewall 32. It is complementary shaped to the lateral protrusion 167 and provides a supplemental guiding function for the longitudinal sliding motion of the biasing member 160.
As it is further apparent from
During a closing motion of the protective cap 12 and when the driver 30 is in the upper or distal end position, which coincides with the unbiased position of the driver 30, the pivoting motion of the protective cap 12 towards the closed position leads to a respective rotation of the pinion segment 151 which is directly transferred into a longitudinal sliding displacement of the biasing member 160 in longitudinal proximal direction relative to the body 11. In this configuration the proximally facing abutment or side edge 169 is in longitudinal abutment with a complementary shaped counter stop face 29 of the driver 30.
As the protective cap 12 is moved further towards the closed position the biasing member 160 applies a respective proximally directed force effect onto the driver 30, thereby moving the driver 30 against the action of the mechanical energy storage 50 into the proximal end position, hence into the biased position. When reaching the biased position the driver 30 engages with the interlock 70 by way of which the driver 30 is prevented from moving towards the distal direction, hence into the unbiased position. A re-opening of the protective cap 12 may then be accompanied by a respective distally directed motion of the biasing member 160 as illustrated in
From
In the following, interaction between the trigger mechanism 90 and the releasable interlock 70 for producing a sequence of dose dispensing procedures is described in greater detail. The driver 30 comprises a counter locking structure 40 on the sidewall 32. The counter locking structure 40 comprises numerous counter locking elements 41, 42, 43, 44 that are separated along the longitudinal direction (z). The interlock 70 comprises a locking element 71 sized and configured to engage with each one of the counter locking elements 41, 42, 43, 44. The mutual interaction between the locking element 71 with each one or with several of the counter locking elements 41, 42, 43, 44 is apparent by the sequence of
The locking element 71 of the releasable interlock 70 is provided on a longitudinal end of an elongated locking spring 73. The locking spring 73 serves to urge or to keep the locking element 71 in engagement with a counter locking structure 40. In the present case the locking spring 73 serves to displace the locking element 71 in the first transverse direction (y). The locking element comprises a pawl 72 configured to engage into recesses 45, 46 provided longitudinally between the row or sequence of the counter locking elements 41, 42, 43, 44. Towards the distal direction the free end of the locking element 71 comprises a beveled edge 74. This way and as the driver 30 provided with the counter locking structure 40 is subject to a longitudinal sliding displacement towards the proximal direction the beveled edge 74 slides along the sequence of counter locking elements 44, 43, 42, 41 and is thereby deflected against the action of the locking spring 73.
When the driver 30 has reached the biased position, and hence when the driver 30 is in a proximal end position the locking element 71 is in engagement with a first counter locking element 41. Here and as illustrated in
As indicated in
Depression of the trigger button 91 leads to an insertion of the trigger head 92 into the second side 48 of the through recess 45, thereby urging the retaining pawl 72 out of the respective recess 45 as illustrated in
Here, the retaining pawl 72, e.g. its free end 75, enters the through recess 46 and engages with its stop face 76 with the second counter locking element 42. Consequently, the dispensing motion of the driver 30 towards the unbiased position is stopped. During this distally directed longitudinal sliding movement of the driver 30 the trigger button 91 may still remain in the depressed configuration as illustrated in
The trigger button 91 is attached to the housing 10. It may be integrally formed with the closure 13. As illustrated in
The inwardly directed depression of the trigger button 91 urges the trigger head 92 into one of the through recesses 45, 46 as provided by the counter locking structure 40. When the driver 30 is subject to a distally directed dispensing motion while the trigger button 91 one is still depressed the trigger head 92 remains trapped in the respective through recess 45 as illustrated in
As shown in detail in
Now and when the trigger button 91 is released the resilient members 97, 98 serve to deflect the trigger button 91 into the initial configuration. As becomes apparent from the illustration of
This way, the trigger head 92 returns into an initial configuration or initial position relative to the trigger button 91. Since in effect, the relative position of the trigger head 91 to the trigger button 91 is the same in both configurations of
Accordingly, and when the trigger button 91 is released in
This way, the trigger mechanism 90 can be actuated at least two times or even several times thereby releasing only a portion of the mechanical energy stored in the mechanical energy storage 50. Between repeated actuations of the trigger mechanism 90 it is not necessary to reload or to recharge the mechanical energy storage 50. Once the user has opened the protective cap 12 the fluid dispensing device 1 can be readily used to dispense a first dose of the fluid e.g. in a first nostril and to subsequently dispense a second dose of the fluid into a second nostril.
While the invention has been described and illustrated herein by references to various specific materials, it is understood that the invention is not restricted to the combinations of material and procedures selected for that purpose. Numerous variations of such details can be implied as will be appreciated by those skilled in the art. It is intended that the specification and examples be considered as exemplary, only, with the true scope and spirit of the invention being indicated by the following claims.
Filing Document | Filing Date | Country | Kind |
---|---|---|---|
PCT/IB2021/061700 | 12/14/2021 | WO |