Technical field

The present invention relates to a medical dispenser comprising a base having at least one sealed cavity containing medicament.

Background of the Invention

There are various types of medical dispensers, such as packages or devices for dispensing tablets, salves or inhalable substances, to mention a few. Some dispensers are provided with one or more compartments containing medicament, the compartments being sealed by a foil. Such compartments may take the form of sealed blisters, sealed pockets or a cavities-containing strip joined to a sealing strip or other suitable forms.

US 6,941,947 discloses a dispenser in the form of a dry powder inhaler. The inhaler comprises a powder-containing blister having a shear layer. The shear layer of the blister is adhered to a blister post. When the user removes a mouthpiece cover from the mouthpiece of the inhaler, a cam- like mechanism drives the blister post to shear the shear layer of the blister. As this occurs, some of the powder in the blister will fall out of the blister into a flow path for subsequent inhalation. The inhaler, being a unit dose inhaler, thus containing only a single dose, contains quite a large number of parts to be assembled.

Summary of the Invention

An object of the present invention is to provide a medical dispenser for which the number of parts to be assembled may be kept low and which nevertheless has a reliable mechanism for opening a sealed compartment or cavity. This and other objects, which will become apparent in the following disclosure, are accomplished by the invention defined in the accompanied claims.

According to a first aspect of the invention, a medical dispenser is provided. The medical dispenser comprises a base having at least one sealed cavity containing medicament, a foil comprising two sides, one side being attached to the base for sealing the medicament within the cavity, a separating element which is attached to the other side of the foil for separating the foil from the cavity, and a link arranged between and attached to the separating element and the base, wherein the link has

- an initial flexed or contracted state in which the foil is attached to the base and

- a subsequent extended state in which the separating element is moved-away from the base, thereby separating the sealing foil from the cavity which becomes uncovered.

When the sealing foil has been separated from the cavity the medicament contained therein becomes accessible. For instance, if the dispenser is in the form of an inhaler the medicament may become entrained in an inhalation flow, or if the dispenser is in the form of a pill container the medicament may be dispensed by shaking or turning the container upside down.

The link arranged between the separating element and the base may be of any suitable type of connecting structure which can shift from said initial flexed or contracted state to said subsequent extended state. An extended state should simply be interpreted as becoming longer in a certain direction compared to the flexed or contracted state. A flexed state may, for instance, be represented by a bent or curved material portion, wherein in the extended state the material portion would be unbent, less curved or straightened out. Alternatively, a flexed state may be represented by two or more joined and angled portions, wherein in the extended state the angle between the portions is larger. A contracted state may, for instance, be represented by a spring portion or a compressed material portion, such as a resilient material. Such a compressed material portion may be squeezed in one direction so that it expands in another direction to shift to said extended state.

It should be noted that "arranged between" is not limited to the link being attached to opposing surfaces of the separating element and the base, respectively. It should rather be understood as allowing a path to be followed from one of the components to the other. Thus, the link may, for instance, be attached to the top surface of the separating element and/or the bottom surface of the base.

Although the link may comprise a single connector extending between the separating element and the base on one side of or circumferentially around the cavity and foil, the link may suitably comprise at least two connectors. This is reflected in at least one example embodiment of the invention, according to which the link comprises two connectors, each connector being arranged between and attached to the separating element and the base, wherein each connector is arrangable in an initial flexed or contracted state and in a subsequent extended state. As previously mentioned, the link may be embodied in various forms. According to at least one example embodiment, each connector of the link is in the form of a hinge. The hinge may be any suitable type of bearing that connects the separating element and the base, allowing a relative movement between them. The hinge may be made of moving components or of flexible material. According to at least one example embodiment, each hinge comprises a knee joint.

Suitably, the knee joint comprises a first leg portion attached to the separating element and a second leg portion attached to the base. In said initial flexed state of the link, the first and second leg portions are positioned at a first angle relative to each other, in said extended state of the link, the first and second leg portions are positioned at a second angle being larger than the first angle. The second angle may e.g. be about 180°. Although the first and second leg portions may be made from separate parts that have been jointed, they may suitably be made in one piece which is represented in at least one example embodiment, according to which said hinges are in the form of living hinges.

According to at least one example embodiment, the hinges are pressable towards each other for reconfiguring the connectors from said initial flexed or contracted state to said subsequent extended state. Thus, in the case of the hinges comprising knee joints, in said initial flexed state the leg portions would extend from the separating element and the base, respectively in a peripheral direction and would then be pressed in a central direction to achieve said extended state. In other words, in said initial flexed state, the two hinges would have leg portions forming respective v-shapes, the tips of which point away from each other. Nevertheless, as an alternative, the hinges could initial be turned the other way. That is, the tips of the v-shapes could point towards each other in said initial flexed state, whereby pulling the hinges away from each other would cause them to shift to said subsequent extended state. According to at least one example embodiment, said initial flexed or contracted state and said subsequent extended state are semi-stable states, wherein, between said initial and subsequent states, each hinge has an intermediate state which is unstable, such that the each hinge snaps to said subsequent state when it changes from said initial state via the intermediate state. The intermediate state may thus represent a threshold, at which the hinge is unstable. Thus, even if not affected by any pressing force, once the threshold has been passed, the hinge will snap into said subsequent extended state. Conversely, if the hinge is let go of before reaching the threshold, it will snap back to said initial state. The movement of the two knee joints is transformed into a movement lifting the separating element from the base. When manually pressing together two knee joints, an imbalance between forces occurs. This leads to one knee joint shifting first, thereby providing an asymmetrical lifting effect on the separating element, whereby one end of the separating element is moved away from the base before the other end of the separating element is moved away from the base. This gradual separation is understood to require less force than if the entire separating element would need to come off at one go. The general idea of utilising asymmetrical separation, not being limited to said manual handling of knee joints, is reflected in at least one example embodiment, according to which the link is configured and dimensioned to provide an asymmetric motion of the separating element when the link shifts from said initial flexed or contracted state to said subsequent extended state, whereby one end of the separating element is moved away from the base before the other end. Rather than manual handling, such as pressing or pulling of the link components, an auxiliary component may be provided. According to at least one example embodiment, such an auxiliary component may be an actuator component which is movable relatively to the link so as to provide a force to the link and reconfigure the link from said initial flexed or contracted state to said subsequent extended state. The actuator component may be connected to the other parts of the dispenser or may be a completely separate part which, in use, is mounted to provide the force to the link.

According to at least one example embodiment, the actuator component comprises a cup-shaped portion having an internal diameter which is undersized in relation to the dimensions of the link when in said initial flexed or contracted state so that when the link is inserted into the cup-shaped portion it is forced to change to said subsequent extended state. Thus, in the case of the link comprising two knee joints, the distance between the actual knee portions (i.e. where the respective leg portions meet) are initially located at a greater distance from each other than the internal diameter of the cup-shaped portion. An asymmetrical separation may be obtained in various ways. For instance, the circumferential wall of the cup-shaped portion may have varying height, so that first a higher wall portion comes into contact with one knee joint, and then later a lower wall portion comes into contact with the other knee joint, thereby the knee joints will become extended one after the other resulting in an asymmetrical separation action. Another alternative would be to have a symmetrical cup-portion, while the two knee portions of the knee joints are located at different levels or the v-shape of the two knee portions having different angles.

According to at least one example embodiment, the separating element, the base and the link are made in one piece. Alternatively, the components may be made as separate pieces which are then assembled.

According to at least one example embodiment, the medical dispenser is in the form of an inhaler which comprises an outlet, such as a mouthpiece or nasal adapter for enabling inhalation of the medicament contained in the cavity. The cavity may suitably be provided with dry powder medicament. After the foil has been separated from the cavity, the powder becomes entrained in a fluid flow when a user inhales. The inhaler may suitably be provided with just a single dose. Nevertheless, the inhaler may be provided with more than one cavity, such as two cavities having one common associated separating element. For instance, if two incompatible drug components are to be inhaled essentially simultaneously, they are suitably provided in two separate cavities. The two cavities may be covered and sealed by one common foil (or one foil portion each), which in turn is attached to a common associated separating element extending across both cavities. Thus, when the separating element is moved away from the cavity, it will bring along the foil, uncovering both cavities from which the drug components can be entrained in an inhalation flow. The cavities could either be located in series in the base, i.e. one cavity being downstream of the other one, or they could be located in parallel, i.e. the inhalation flow reaches the cavities essentially simultaneously.

In the case of the dispenser being in the form of an inhaler, according to at least one example embodiment, after separation of the foil from the cavity, the space established between the separating element and its attached foil on the one side and the base and its cavity on the other side forms part of a flow path. Thus, the separating element is not just discarded when it has been used to open the sealed cavity. Rather it now functions as a flow path-defining element together with the attached foil.

The foil in the medical dispenser (such as an inhaler, a container or other type of package, etc.) may be attached to the base and the separating element by welding, gluing or other suitable method. It should be noted that the term "foil" is not limited to a single material layer. On the contrary a foil may comprise a plurality of layers. For instance, the foil may comprise a metal layer which is coated with lacquer or polymer layer on one or both sides in any suitable combination in order to provide the desired stiffness, attachment capability, etc. In order to separate the foil from the cavity, the foil should be appropriately attached to the separating element. According to at least one example embodiment, the attachment force between the separating element and the foil is larger than the attachment force between the base and the foil.

There are various ways to obtain a larger attachment force at the separating element/foil interface than at the foil/base interface. According to at least one example embodiment, the contact surface between a separating element and the foil is larger than the contact surface between the foil and the base. In other words the separating element/foil interface is larger than the foil /base interface. If the separating element covers the entire foil, then the contact surface will automatically be larger between the separating element and the foil than the contact surface between the foil and the base, because the piece of the foil located directly above the cavity opening is not attached to anything and only the surrounding area of the foil is attached to the base.

Another way to obtain different attachment forces is considered in at least one other example embodiment. The foil may comprise a first coating layer to which the base is attached and a second coating layer to which the separating element is attached, wherein the tensile strength of the second coating layer is larger than the tensile strength of the first coating layer. The layers can provide different bonding properties, e.g. welds of different types of material, or glues of different types or amounts, or any combination thereof. Other ways to obtain the difference in attachment forces could be to provide the separating element with specially designed geometric features, e.g. grooves into which the foil may be attached or other features that e.g. pierce the foil to create a firm grip.

Although the foil may be folded into grooves of the separating element or otherwise curved around the separating element e.g. to increase the attachment area, the foil may suitably just be flat, i.e. only extending in a single plane parallel to the base. This enables a simple assembling of the separating element to the foil. When they have become assembled the foil may be attached to the base. An alternative would be to first attach the foil to the base, and then attach the separating element onto the foil.

Suitably, the stiffness of the separating element is substantially larger than the stiffness of the foil, wherein the separating element enables the foil to perform a rigid body motion, and may thus become snapped off the base rather than peeled off.

In a medical dispenser designed in the form of an inhaler, the contact area between the foil and the attached separating element is suitably dimensioned in such way that no ruptured flow-obstructing foil parts will remain after the separation has occurred. In other words, the flow path downstream and upstream of the cavity opening should be free from any obstructing fringes of foil. Suitably, on the base, the flow path upstream and downstream of the cavity opening is completely foil free after the separation has occurred. This may be accomplished by designing the separating element with longer (or equal) extension in the flow path direction than that of the foil. Since the foil extends across the cavity opening in order to seal the cavity, the attached separating element should also extend at least across the cavity opening. In the case of the medical dispenser being in the form of an inhaler, it may contain various drugs and/or bioactive agents to be inhaled.

The bioactive agent may be selected from any therapeutic or diagnostic agent. For example it may be from the group of antiallergics, bronchodilators, bronchoconsitrictors, pulmonary lung surfactants, analgesics, antibiotics, leukotrine inhibitors or antagonists, anticholinergics, mast cell inhibitors, antihistamines, antiinflammatories, antineoplastics, anaesthetics, anti-tuberculars, imaging agents, cardiovascular agents, enzymes, steroids, genetic material, viral vectors, antisense agents, proteins, peptides and combinations thereof. Examples of specific drugs which can be incorporated in the inhalation device according to the invention include mometasone, ipratropium bromide, tiotropium and salts thereof, salemeterol, fluticasone propionate, beclomethasone dipropionate, reproterol, clenbuterol, rofleponide and salts, nedocromil, sodium cromoglycate, flunisolide, budesonide, formoterol fumarate dihydrate, Symbicort™ (budesonide and formoterol), terbutaline, terbutaline sulphate, salbutamol base and sulphate, fenoterol, 3-[2-(4-Hydroxy- 2-oxo-3H-l,3-benzothiazol-7-yl)ethylamino]-N-[2-[2-(4- methylphenyl)ethoxy]ethyl]propanesulphonamide, hydrochloride. All of the above compounds can be in free base form or as pharmaceutically acceptable salts as known in the art. Combinations of drugs may also be employed, for example formoterol/budesonide; formoterol/fluticasone; formoterol/mometasone; salmeterol/fluticasone; formoterol/tiotropium salts; zafϊrlukast/formoterol, zafϊrlukast/budesonide; montelukast/formoterol; montelukast/budesonide; loratadine/montelukast and loratadine/zafϊrlukast. Further combinations include tiotropium and fluticasone, tiotropium and budesonide, tiotropium and mometasone, mometasone and salmeterol, formoterol and rofleponide, salmeterol and budesonide, salmeterol and rofleponide, and tiotropium and rofleponide.

According to a second aspect of the invention, a method of producing a medical dispenser is provided. The method comprises: - forming in one piece: a base having at least one cavity, a separating element, and a link arranged between the separating element and the base,

- introducing medicament into said cavity, and - arranging the separating element to cover the cavity in such manner which provides the link in a flexed or contracted state.

According to at least one example embodiment, the method comprises providing a foil for sealing the cavity containing the medicament by:

- attaching one side of a foil to either one of said base and said separating element, and - attaching, after said act of arranging the separating element, the other side of the foil to the other one of said base and said separating element. For instance, the foil may initial become attached to the separating element before, during or after the medicament is introduced into the cavity, and then subsequently be attached to the base to seal the cavity. Alternatively, the foil may be attached to the base after the introduction of the medicament, and then when placing the separating element on top, the foil is also attached to the separating element.

According to at least one example embodiment, the link comprises a first connector and a second connector, wherein said act of forming comprises

- forming the first connector connected to both the separating element and the base, and

- forming the second connector connected to only one of said separating element and said base, the method further comprising,

- attaching, after said act of arranging the separating element, the second connector to the other one of said separating element and said base. The act of attaching the free end of the connector may comprise welding, gluing, etc.

It should be understood that the second aspect of the invention encompasses any embodiments or any features described in connection with the first aspect of the invention, as long as those embodiments or features are compatible with the method of the second aspect. Brief description of the drawings

Fig. Ia is a schematic perspective view, partly in cross-section, of a medical dispenser in the form of an inhaler before it is used, in accordance with at least one example embodiment of the invention.

Fig. Ib is a schematic illustration of the medical dispenser when an airflow passes through it.

Figs. 2a-c illustrate schematically an opening sequence of a medical dispenser, in accordance with at least one example embodiment of the invention. Figs. 3a-c illustrate schematically an opening sequence of a medical dispenser, in accordance with at least one other example embodiment of the invention.

Figs. 4a-e illustrate schematically a method of assembling a medical dispenser, in accordance with at least one example embodiment of the invention.

Figs. 5a-5b is a schematic illustration of a medical dispenser in accordance with at least yet another example embodiment of the invention.

Detailed description of the drawings

Fig. Ia is a schematic perspective view, partly in cross-section, of a medical dispenser in the form of an inhaler 2 before it is used, in accordance with at least one example embodiment of the invention. The inhaler 2 is a single dose inhalation device which comprises one cavity 4 in a base 6. However, an alternative would be to have two cavities containing different substances to be inhaled simultaneously in a single dose. The shown cavity 4 contains a dry powder substance to be inhaled and is sealed by a foil 8. The foil 8 is attached by any suitable type of bonding, welding, gluing etc, to an area 6a of the base 6 which surrounds the rim of the cavity opening. The foil 8 extends past the diameter of the cavity 4, both upstream and downstream. A separating element 10 is attached to the foil 8 by any suitable type of bonding, welding, gluing, etc., the separating element 10 having at least as large extension as the foil 8 both upstream and downstream of the cavity 4. Thus, the contact area between the separating element 10 and the foil 8 is larger than the contact area between the foil 8 and the base 6, enabling the achievement of a larger attachment force between the separating element 10 and the foil 8 compared to the attachment force between the foil 8 and the base 6. The separating element 10 is herein exemplified as having the shape of a rectangular parallelepiped, however, other shapes are conceivable.

A desiccant may be provided below the cavity. The cavity 4 may either be provided in a separate cassette which is insertable into a mating space in the rest of the base 6 or made in one piece with the base, e.g. if no desiccant is used.

A link 12 is arranged between and attached to the separating element 10 and the base 6. The link 12 is herein presented as a pair of knee joints 14 functioning as living hinges. Each knee joint 14 has a first leg 16 attached to the separating element 10 and a second leg 18 attached to the base 6. The legs 16, 18 meet at a joint 20.

Fig. Ib is a schematic illustration of the inhaler 2 when an inhalation flow passes through it. The two joints 20 have been pressed towards each other, i.e. towards the centre of the inhaler 2, resulting in the legs 16, 18 moving from an angled (flexed) state shown in Fig. Ia to a substantially straight (extended) state shown in Fig. Ib. As the link 12 has moved from the initial flexed state to the subsequent extended state the separating element 10 has now been lifted up from said base area 6a and has brought along the attached foil 8. The cavity 4 now being uncovered enables an airflow, caused by a user's inhalation, to entrain the powdered substance and deliver it to an outlet, such as a mouthpiece or a nasal adapter. Most components of the inhaler, such as the base 6, the separating element 10 and the link 12 are suitably made of a plastic material, such as a polymer, however, other materials, such as metal or ceramic are conceivable alternatives.

Figs. 2a-c illustrate schematically an opening sequence of a medical dispenser 102, in accordance with at least one example embodiment of the invention. Although the medical dispenser may suitably be in the form of an inhaler, the illustrated opening sequence may also be provided for other types of dispensers.

In Fig. 2a the medical dispenser 102 is illustrated as comprising a base 106 provided with a foil-sealed cavity 104, under which a desiccant may be provided if desired. A separating element 110 in the form of a lid is attached to the top of the foil 108. A link 112 comprises two connectors, comprising two leg portions which are joined to form a respective v-shaped knee joint 114a, 114b. The tips 120a, 120b of the two v-shaped joints 114a, 114b point away from each other. The link 112 is now in its initial flexed state. A user may with his/her fingers apply a centrally directed pressure to the knee joints, as illustrated by the arrows in Fig. 2b. When the tips 120a, 120b of the knee joints 114a, 114b are pressed towards each other, they will shift from the current semi-stable initial state past an unstable intermediate state into another semi-stable state, namely an extended state (Fig. 2c). The horizontal movement of the knee joints 114a, 114b is transformed into a vertical movement lifting the separating element 110. The transformation provides a mechanical effect in that, when pressing the two knee joints 114a, 114b, an imbalance between the forces occurs. This leads to one knee joint 114b shifting to its extended state before the other 114a, which results in an asymmetrical lifting of the separating element 110, as illustrated in Fig. 2b. Continued pressing of the knee joints 114a, 114b, after the state- shifting of one of the knee joints 114b and the resulting raising of one end 110b of the separating element 110, leads to a state-shifting of the second knee joint 114a as well, whereby the entire separating element 110 becomes raised, as illustrated in Fig. 2c. The medicament is now accessible for dispensing.

Figs. 3a-c illustrate schematically an opening sequence of a medical dispenser 202, in accordance with at least one other example embodiment of the invention. Rather than pressing the knee joints 214a, 214b with his/her fingers, as was discussed in connection with Figs. 2a-c, the user has an auxiliary actuator component 250 at his/her disposal. The actuator component 250 is cup-shaped and is asymmetrically designed in such way that a first wall 252 portion is higher than a second wall portion 254. The internal diameter d of the cup-shaped actuator component 250 is smaller than the distance D between the tips 220a, 220b of the v-shaped knee joints 214a, 214b. Thus, by pushing (Fig. 3b) the base 206 of the dispenser 202 and the knee joints 214a, 214b through the opening of the actuator component 250 the tips 220a, 220b of the v-shapes will be forced closer towards each other, resulting in a shift from the initial flexed state to the subsequent extended state of the knee joints 214a, 214b, . The higher first wall portion 252 will affect its associated knee joint 214b with the horizontal force first, resulting in the vertical lifting of the corresponding end portion 210b of the separating element 210 (Fig. 3b), and thereafter the lower second wall portion 254 will affect its associated knee joint 214a, resulting in lifting the rest of the separating element 210 (Fig. 3c).

Figs. 4a-e illustrate schematically a method of assembling a medical dispenser, in accordance with at least one example embodiment of the invention. In a first step illustrated in Fig. 4a, the base 306, the separating element 310 and the link (comprising two connectors which comprise knee joints 314a, 314b) are moulded in one piece. One of the connectors (comprising knee joint 314a) is connected to both the separating element 310 and the base 306. The other connector (comprising knee joint 314b) is, at this stage, only connected to the separating element 310 while its other end 315 is loose.

In a second step illustrated in Fig. 4b, the foil 308 is attached to the separating element 310.

In a third step illustrated in Fig. 4c, a desiccant-containing cassette 360 forming a cavity 304 is inserted into the moulded cavity opening in the base 306. This step may be optional.

In a fourth step illustrated in Fig. 4d, the medicament 322 is introduced onto the desiccant containing cassette 360, or if the cassette 360 is not used, directly into the base cavity.

In a fifth step illustrated in Fig. 4e, the separating element 310 is folded over the base 306. The foil 308 and the loose end 315 of the connector and are welded to the base 306. The loose end 315 is herein exemplified as a bulge which fits into a mating recess in a ledge 307 of the base 306, however, other means of fitting them together are conceivable.

Figs. 5a-5b is a schematic illustration of a medical dispenser 402 in accordance with at least yet another example embodiment of the invention. As with the previously discussed figures, the illustrated dispenser comprises a link arranged between and attached to the separating element 410 and the base 406. The link comprises a circumferentially oriented bellows 470 which is connected to a hydraulic or pneumatic pump 472. In Fig. 5a, the bellows 470 is in an initial contracted state in which the foil 408 is attached to the base 406. In Fig. 5b, the pump 472 has introduced more fluid into the bellows 470, wherein it is now changed into an extended state in which the separating element 410 is moved- away from the base 406, thereby separating the sealing foil 408 from the cavity 404 which becomes uncovered.

Although, the drawings have illustrated various embodiments, it should be understood that there are numerous more. For instance, the base may have an H-shaped cross section, i.e. two parallel walls connected by a substantially perpendicular connecting wall. Sealing foil portions may be attached onto the top and the bottom, respectively, of the parallel walls in order to create an upper sealed compartment above the connecting wall and a lower sealed compartment below the connecting wall. Powdered medicament may be provided in the upper sealed compartment and a desiccant may be provided in the lower sealed compartment. A separating element may be attached to the foil that seals the compartment containing the medicament. A link, such as comprising hinges, may extend from the separating element to the parallel walls of the base.