Patent Description:
Such a dry powder inhaler is known, for example from <CIT> or from <CIT>. Those dry powder inhalers are typically non-pressurized inhalers. A capsule that is arranged in the capsule receptacle of the dry powder inhaler can be pierced by the needles. When air is sucked in by a patient through a mouthpiece, the capsule is lifted from the capsule receptacle into a capsule chamber and rotates in the capsule chamber. Upon rotation of the capsule, dry powder contained in the capsule is dispersed by centrifugal forces during rotation and mixed with air such that it can be inhaled by a patient.

<CIT> discloses a dry powder inhaler for a capsule containing dry powder. The inhaler comprises a housing having a capsule receptacle, two actuator buttons arranged on opposing sides of the housing and two perforation needles, each needle being fixedly connected to an actuator button and movable relative to the housing towards each other from a normal position to a perforation position along an actuation direction to perforate a capsule arranged in the capsule receptacle, wherein a first end of each actuator button is connected to the housing at a lower portion of the housing and in that a second free end of each actuator button is movable into the perforation position such that the perforation needle is moved along a circular line.

In order to disperse the dry powder contained in the capsule, the capsule has to be perforated by the needles.

The problem of the known mono-dose dry powder inhalers is that the dosage of powder is limited. When piercing the capsule directly in its hemispherical ends, the amount of powder to be dispersed during inhalation is limited because the flow of the dry powder out of the pierced openings is obstructed during rotational movement of the capsule due to the arrangement of the openings. The obstruction can be caused by cut-out portions of the capsule shell are bended inwards by the needles when piercing the capsule. Moreover, the known dry powder inhalers are limited in the maximum dosage of dry powder. In certain areas of application a high dosage in the range of about <NUM> to about <NUM> of dry powder in one or multiple capsules is required such as in treatments or clinical tests for cystic fibrosis, tuberculosis, pulmonary artery hypertension, neurologic and congenital disorders, Parkinson, asthma, Chronic obstructive pulmonary disease (COPD) etc..

Moreover, known inhalers often have the problem that a wide variation in the inhalation resistance can occur depending on the pulmonary capacity of a user or patient, wherein a high inhalation resistance - at a typical pulmonary capacity of about <NUM>/min - should preferably be avoided. It is therefore an object of the present invention to provide a cost effective dry powder inhaler for dispersion of dry powder, which provides for easy handling of large dosages of dry powder without a high inhalation resistance.

This object is solved by a dry powder inhaler according to the features of claim <NUM>. Preferred embodiments are matter of the dependent claims.

An aspect of the description is directed to the following subject-matter: A dry powder inhaler for a capsule containing dry powder, the inhaler comprising a base body having a capsule receptacle, two actuator buttons arranged on opposing sides of the base body and two perforation needles, each needle being fixedly connected to a respective one of the actuator buttons and movable relative to guiding sections of the base body towards each other from a normal position to a perforation position along an actuation direction to perforate a capsule arranged in the capsule receptacle, wherein the capsule receptacle is arranged in an inclined angle within the range of about <NUM>° to about <NUM>° with respect to the actuation direction, characterized in that an extra-centric tip of at least one of the piercing needle is facing the longitudinal axis of the other piercing needle.

When using the dry powder inhaler, the extra-centric tip and its arrangement result in a larger and triangular-shaped opening when piercing the capsule. This makes it easier to expel the powder contained in the capsule. The air-powder mixture inhaled by the patient can be improved in this way. As a result of the fact that larger quantities of powder are safely discharged from the capsule, a reduction of emitted dose variaton is achieved and thus the drug can be delivered more precisely. Therefore, exact dosing of drugs is improved.

Moreover, the piercing method results in more homogeneous shaping and size of the piercing holes. Accordingly, a homogeneity between different doses of the drug is achieved compared to other forms of capsule piercing.

The cutted shape of the opening prevents the closing of the inwards portion of the capsule due to its unique triangular-like shape with two lateral parts bended inwards. This has to do with the needle-tip shape and a contact direction with the capsule.

A beneficial example is characterized by that the extracentric tip of both the piercing needles face the longitudinal axis of the other piercing needle.

Another example is characterized by that the extracentric tip of at least one of the perforation needles passes an imaginary plane, which is tangential to an associated curved section of the capsule receptacle, with an angle between <NUM>° and <NUM>°, in particular between <NUM>° and <NUM>°, in particular between <NUM>° and <NUM>°, when being moved between the normal position to the perforation position along the actuation direction.

This nearly perpendicular movement of the needle tip through the imaginary plane causes the needle tip to enter the capsule shell nearly perpendicularly. By this piercing arrangement, the hole in the capsule will be enlarged.

Another example is characterized by that a central longitudinal axis of the guiding section enters a distal portion of the curved section in the capsule receptacle.

This arrangement causes the needle to enter in a distal portion of the associated capsule hemisphere. Therefore, the hole generated in the capsule is at a distal point easing the way for the powder to be released from the inside of the capsule.

For example, benefits can be achieved by that at least one of the guiding sections and the associated needle are arranged such that the tip of at least one of the needles enters the capsule receptacle in a distal portion of a curved section of the capsule receptacle.

Going further, an example is advantageous by that the guiding sections of the base body extend in imaginary parallel planes.

According to an example of the inhaler, the first end of each actuator button is pivotally attached to the housing.

It is particularly preferred if the first end of each actuator button is connected to the housing via a ball joint snap-on connection pivoting around a pivot axis. By providing a ball joint snap-on connection, the actuator buttons can be attached to the lower portion of the housing by engaging the ball point snap-on connection.

Advantageously, the actuator buttons are pivotable around a pivoting angle of about <NUM> to <NUM>°, preferably of about <NUM>°.

In another preferred example of the inhaler, the ball joint snap-on connection comprises hemi-spherical protrusions arranged on the housing and hemi-spherical recesses arranged on the actuator buttons complementary to the hemispherical protrusions, wherein the protrusions and recesses extend along the pivot axis. In order to engage the ball joint snap-on connection, the hemi-spherical protrusions are preferably arranged on the housing such that they can be elastically pushed into a release position along the direction of the pivot axis. In the release position, the recesses of the actuator buttons and the protrusions of the housing can be superimposed such that the protrusions can engage the recesses and elastically move back into an engagement position of the ball joint snap-on connection.

It is particularly preferred if the perforation needles are arranged in an area of the second free end of each actuator button spaced away from the first end of the actuator button. Preferably, the perforation needles are arranged on the inside surfaces of the actuator buttons facing each other. By arranging the perforation needles in an area of the second free end of each actuator button, a large movement range can be provided despite connecting a first end of each actuator button to the housing.

In a particularly preferred example, the dry powder inhaler comprises a spring element acting upon the actuator buttons such that the actuator buttons are pre-loaded into the normal position. Preferably, the spring element is a helical spring.

In another preferred example of the dry powder inhaler, the housing comprises two openings configured to receive the actuator buttons such that an outside surface of the housing and the actuator buttons is substantially flush when the actuator buttons are in the normal position. It is particularly preferred if the actuator buttons in particular their flaps on the laterals close the openings in the housing in the normal position in a substantially airtight manner such that no or substantially no air can pass between the actuator buttons and the opening edges.

The dry powder inhaler is characterized in that an intermediate air chamber is formed between the base body and the covering body, wherein the mouthpiece has an inhaling inlet fluidly connected to the capsule chamber and at least one mouthpiece air inlet arranged on a lateral outside of the mouthpiece and fluidly connected to the intermediate air chamber and wherein the base body has at least one base body air inlet being fluidly connected to the capsule chamber and to the intermediate air chamber and ending in the capsule chamber.

Preferably, the base body is connected to the covering body such that no or substantially no air can be sucked out of the capsule chamber at the joint surface between the base body and the covering body. It is particularly preferred if two actuator buttons are provided on opposing sides of the covering body movable between a normal position and a perforation position. Advantageously, the actuator buttons are closing the covering body in the normal position in a substantially airtight manner such that no or substantially no air can pass between the actuator buttons and opening edges of the openings which are configured to receive the actuator buttons. It is therefore particularly preferred that substantially no air can be sucked in between the covering body and the actuator buttons when the actuator buttons are in the normal position. In a preferred embodiment of the dry powder inhaler the at least one base body air inlet ends tangentially into the capsule chamber. Preferably, two base body air inlets are provided. This provides a more stable resistance to air flow during inhalation as no quanity of air stream can erraticly enter the housing chamber during inhalation.

When a patient or user is using the dry powder inhaler, a capsule arranged in the capsule chamber can be pierced by moving the actuator buttons from the normal position into the perforation position along an actuation direction. After piercing the capsule, the actuator buttons are moved back into the normal position. When a patient or user is sucking in air through the inhaling inlet of the mouthpiece, a partial vacuum in the capsule chamber can be generated wherein air is sucked through the capsule chamber through the at least one base body air inlet generating an air flow that lifts the capsule in the capsule chamber and rotates the capsule in the capsule chamber such that dry powder contained in the capsule chamber can be dispersed.

Advantageously, the air sucked through the capsule chamber through the at least one base body air inlet can be directed from the mouthpiece air inlet and through the intermediate air chamber. By directing the airflow through the intermediate air chamber, a dry powder inhaler can be provided with less necessary pressure for achieving a certain average flow rate.

According to a preferred example of the dry powder inhaler, the capsule chamber is circular cylindrical and comprises a hemi-spherical end-section having a capsule receptacle. The capsule receptacle can be arranged in an angle with respect to an actuation direction of the actuator buttons. Nevertheless, it is also possible that the capsule receptacle is arranged parallel to the actuation direction.

Preferably, the mouthpiece comprises a cylindrical protrusion configured to extend at least partially into the capsule chamber.

In a particularly preferred example of the dry powder inhaler, the cylindrical protrusion of the mouthpiece extends into the capsule chamber wherein a lateral surface of the cylindrical protrusion is configured to sealingly abut on an inside surface of the capsule chamber. Preferably, the cylindrical protrusion abuts such the inside surface of the capsule chamber that substantially no air can be sucked out of the capsule chamber between the inside surface of the capsule chamber and the lateral surface of the cylindrical protrusion.

In another preferred example of the dry powder inhaler, the base body comprises at least one base body duct overlapping with and in fluid connection with the mouthpiece air inlet, wherein the base body duct is fluidly connected to the intermediate air chamber and ends in the intermediate air chamber. Preferably, the base body duct is an opening in the base body overlapping with the mouthpiece air inlet.

Preferably, the base body comprises a cylindrical shoulder which is preferably oval and a base body plate which is preferably oval and arranged perpendicular to the cylindrical shoulder. Preferably, the base body plate defines an outside wall of the intermediate air chamber. Advantageously, the at least one base body duct is an opening in the base body plate overlapping with the mouthpiece air inlet such that the intermediate air chamber is fluidly connected to the mouthpiece air inlet.

In a preferred example of the dry powder inhaler, the capsule chamber is attached to the base body plate and opens into the base body plate.

According to an advantageous example, the respective actuator button is pivotable around a pivot axis with a pivoting angle, for example of about <NUM>° to <NUM>°, preferably of about <NUM>°, wherein the respective actuator button comprises a countour moving along a circular path around the pivot axis, and wherein the countour engages in a guiding countour of the base body.

Advantageously, guiding means are provided to obtain piercing results that are stable and repetitive with regard to the realeased powder.

According to an advantageous example, the actuator button comprises a sealing surface that surrounds at least partly an outward actuator surface, and wherein the contour that engages in the guiding contour of the base body is arranged proximal to or flush to the outwardly facing sealing surface of the respective actuator button.

Advantageously, the functions of guiding and sealing are seperated.

Further details and advantages of the invention can be taken from the following description, on the basis of which the embodiments of the invention that are represented in the Figures are described and explained in more detail.

<FIG> show a dry powder inhaler <NUM> for a capsule containing dry powder (shown in <FIG>). The dry powder inhaler <NUM> comprises a housing <NUM> having a base body <NUM> and a covering body <NUM>. The dry powder inhaler <NUM> furthermore comprises a mouthpiece <NUM>. The mouthpiece <NUM> has a mouth portion <NUM> having a central opening <NUM> for inhaling air that mixes with dry powder contained in a capsule arranged in the dry powder inhaler <NUM>.

The dry powder inhaler <NUM> comprises two actuator buttons <NUM> arranged on opposing sides of the housing <NUM> which are movable relative to the housing <NUM> towards each other along an actuation direction which is indicated by arrows <NUM> from a normal position to a perforation position to perforate a capsule arranged in the dry powder inhaler <NUM>. The housing <NUM> comprises two openings <NUM> configured to receive the actuator buttons <NUM> such than an outside surface <NUM> of the housing <NUM> and the actuator buttons <NUM> is substantially flush when the actuator buttons <NUM> are in the normal position.

<FIG> shows a sectional view of a part of the dry powder inhaler <NUM> of <FIG> and <FIG>. Each actuator button <NUM> is attached the covering body <NUM>, i.e. the housing <NUM>, wherein a perforation needle <NUM> is provided being fixedly connected to an actuator button <NUM>. <FIG> shows only one perforation needle <NUM> because the needles <NUM> are arranged with an offset concerning the cutting plane of <FIG>.

A first end <NUM> of each actuator button <NUM> is connected to the housing <NUM>, i.e. the covering body <NUM> in a lower portion of the housing <NUM>. The perforation needles <NUM> are arranged in an area of a second free end <NUM> of the actuator buttons <NUM>. This second free end <NUM> is spaced away from the first end <NUM>. The second free end <NUM> of the actuator buttons <NUM> is movable from the normal position into the perforation position shown in <FIG> such that a tip of the perforation needle <NUM> is moved along a circular line.

The first end <NUM> of each actuator button <NUM> is pivotably attached to the housing <NUM> by use of a ball joint snap-on connection <NUM> pivoting around a pivot axis, wherein the actuator button is pivotable around a pivoting angle <NUM> of about <NUM>° to <NUM>°, preferably of about <NUM>°. Accordingly, the perforation needles <NUM> are inclined with respect to a plane <NUM> which is perpendicular to a longitudinal axis <NUM> of the dry powder inhaler <NUM> in a perforation angle <NUM> of about <NUM>° to <NUM>°, preferably of about <NUM>° when the actuator buttons <NUM> are in the perforation position.

The ball joint snap-on connection <NUM> comprises hemispherical protrusions (not shown in the drawings) arranged on the housing <NUM> and hemi-spherical recesses <NUM> (shown in <FIG>) arranged on the actuator buttons <NUM>, wherein the protrusions and recesses extend along the pivot axis and wherein the protrusions engage the recesses.

By arranging the two actuator buttons <NUM> on opposing sides of the housing <NUM> and connecting each actuator button <NUM> to the housing <NUM> at a lower portion of the housing <NUM>, the actuator buttons <NUM> can be pre-loaded into the normal position by use of only one spring element.

Such a spring element is shown in <FIG> which shows a perspective view with of parts of the dry powder inhaler. The dry powder inhaler <NUM> comprises a helical spring <NUM> arranged in shell-like spring-guiding members <NUM> of the base body <NUM> and acting upon the actuator buttons <NUM> such that the actuator buttons <NUM> are pre-loaded into the normal position against the direction depicted by arrows <NUM>.

The base body <NUM> of the dry powder inhaler <NUM> which is made of one piece is shown in more detail in <FIG> and <FIG>. <FIG> furthermore shows a top view of the base body <NUM> of <FIG> and <FIG>. The base body <NUM> has an elliptical or oval base body plate <NUM> and an oval cylindrical shoulder <NUM> extending perpendicular to the base body plate <NUM> and connected to the base body plate <NUM>. The base body <NUM> has a capsule chamber <NUM> having a capsule receptacle <NUM> for receiving a dry powder capsule and two downwardly extending plate members <NUM> that are substantially parallel to each other. The spring-guiding members <NUM> are arranged coaxially to the actuation direction <NUM> wherein the plate members <NUM> are arranged perpendicular to the actuation direction <NUM>. At a free end of the plate members <NUM>, bearing sections <NUM> for the actuator buttons <NUM> are provided.

The capsule chamber <NUM> is open towards an upper end portion <NUM> of the base body <NUM>. The capsule chamber <NUM> has a circular cylindrical section <NUM> and a hemi-spherical or conical end section <NUM>, wherein the capsule receptacle <NUM> is arranged in the hemi-spherical end section <NUM> of the capsule chamber <NUM>. The capsule chamber <NUM> has, for example, a volume of about <NUM> to about <NUM><NUM> or less. The capsule receptacle <NUM> is arranged perpendicular to the longitudinal axis <NUM> of the dry powder inhaler <NUM>.

The capsule receptacle <NUM> is furthermore arranged in an inclined angle <NUM> within the range of <NUM>° to <NUM>° with respect to the actuation direction <NUM>. The base body <NUM> comprises two hollow needle guiding sections <NUM> configured to guide the needles <NUM> and being arranged perpendicular to the longitudinal axis <NUM> of the inhaler <NUM> and ending in the capsule receptacle <NUM>. Those needle guiding sections <NUM> and the needles <NUM> are arranged parallel to the actuation direction <NUM> and spaced apart from a middle plane <NUM> of the base body <NUM> in a distance <NUM>. The needles <NUM> are arranged on opposing sides of the middle plane <NUM>.

According to another embodiment not shown in the drawings and not claimed, the capsule receptacle <NUM> is not arranged in an inclined angle with respect to the actuation direction <NUM> but is parallel to the actuation direction <NUM>. In that case the needle guiding sections <NUM> and the needles <NUM> are arranged parallel to the actuation direction <NUM> but are not spaced apart from the middle plane <NUM> of the base body <NUM>. With this embodiment, a capsule arranged in the capsule receptacle <NUM> can be pierced directly in the hemi-spherical end-section of the capsule.

The circular cylindrical section <NUM> has a diameter <NUM> which is bigger than the length of the capsule receptacle <NUM>. The size of the capsule receptacle <NUM> corresponds with the size of the capsule such that the capsule receptacle <NUM> is only slightly bigger than the capsule to ensure that the capsule is held in the capsule receptacle <NUM> when pushing the actuator buttons <NUM> and piercing the capsule with the needles <NUM>. Preferably, the capsule receptacle <NUM> is configured to receive a capsule with a volume in the range of about <NUM> to about <NUM><NUM>.

The base body <NUM> furthermore has two base body air inlets <NUM> in the area of the cylindrical shoulder <NUM> which are ending tangentially into the capsule chamber <NUM> and are arranged perpendicular to the middle plane <NUM> of the base body <NUM>. The mouthpiece <NUM> is fastened to the base body <NUM> via a hinge. A lower part of the hinge is depicted in <FIG> and having the reference numeral <NUM>. The base body <NUM> also comprises two base body ducts <NUM>.

Between the base body <NUM> and the covering body <NUM> of the housing <NUM> an intermediate air chamber <NUM> is formed. The central opening <NUM> of the mouthpiece <NUM> functions as inhaling inlet and is fluidly connected to the capsule chamber <NUM> via a perforated plate <NUM> as shown in <FIG>. The mouthpiece <NUM> has two mouthpiece air inlets <NUM> on a lateral outside of the mouthpiece which are fluidly connected to the intermediate air chamber <NUM>.

The base body air inlets <NUM> are also fluidly connected to the intermediate air chamber <NUM> and to the capsule chamber <NUM>. The base body comprises two base body ducts <NUM> overlapping with and in fluid connection with the mouthpiece air inlets <NUM>. The base body ducts <NUM> are also fluidly connected to the intermediate air chamber <NUM> and end in the intermediate air chamber <NUM>.

On the side facing away from the mouth portion <NUM>, the mouthpiece <NUM> comprises a cylindrical protrusion <NUM> configured to extend at least partially into the capsule chamber <NUM>. The perforated plate <NUM> is arranged in an end-section of the cylindrical protrusion <NUM>. A lateral surface <NUM> of the cylindrical protrusion <NUM> is configured to sealingly abut on an inside surface <NUM> of the capsule chamber <NUM> such that substantially no air can pass between the inside surface <NUM> of the capsule chamber <NUM> and the lateral surface <NUM> of the cylindrical protrusion.

<FIG> shows a top view of the base body <NUM> of <FIG> when viewing in the direction of arrow <NUM> in <FIG>. The capsule receptacle <NUM> has a longitudinal axis <NUM> which is arranged in an inclined angle <NUM> within the range of about <NUM>° to about <NUM>° with respect to the actuation direction <NUM> or the middle plane <NUM>. The needles <NUM> are piercing a capsule which can be arranged in the capsule receptacle <NUM> in an angle <NUM> with respect to the longitudinal axis <NUM> of the capsule receptacle <NUM> or the capsule.

Such a capsule <NUM> is shown in <FIG>. The longitudinal axis <NUM> of the capsule <NUM> is arranged to a longitudinal axis <NUM> of the needles <NUM> in the angle <NUM>.

<FIG> depicts a schematical cross section of the base body <NUM> along the middle axes of the guiding sections <NUM>.

The figure concerns a dry powder inhaler <NUM> for a capsule <NUM> containing dry powder, the inhaler <NUM> comprising a base body <NUM> having a capsule receptacle <NUM>, two actuator buttons <NUM> arranged on opposing sides of the base body <NUM> and two perforation needles <NUM>, each needle <NUM> being fixedly connected to a respective one of the actuator buttons <NUM> and movable relative to guiding sections <NUM> of the base body <NUM> towards each other from a normal position to a perforation position along an actuation direction <NUM> to perforate a capsule <NUM> arranged in the capsule receptacle <NUM>, wherein the capsule receptacle <NUM> is arranged in an inclined angle <NUM> within the range of about <NUM>° to about <NUM>° with respect to the actuation direction <NUM>, characterized in that an extracentric tip <NUM> of at least one of the piercing needle <NUM> is facing the longitudinal axis <NUM> of the other piercing needle <NUM>.

There is depicted that the extracentric tip <NUM> of both the piercing needles <NUM> face the longitudinal axis <NUM> of the other piercing needle <NUM>.

Shown is that the extracentric tip <NUM> of at least one of the perforation needles <NUM> passes an imaginary plane <NUM>, which is tangential to an associated curved section <NUM> of the capsule receptacle <NUM>, with an angle between <NUM>° and <NUM>°, in particular between <NUM>° and <NUM>°, in particular between <NUM>° and <NUM>°, when being moved between the normal position to the perforation position along the actuation direction <NUM>. In other words, the axis of movement of the perforation needle <NUM> passes the imaginary plane <NUM> perpendicularly or nearly perpendicularly.

In the section shown perpendicular to the vertical axis z, the imaginary plane <NUM> abuts the section <NUM> and passes through an edge of the opening <NUM>, wherein said edge faces the axis <NUM> of the opposing guiding section <NUM>.

Shown is that a central longitudinal axis <NUM> of the guiding section <NUM> enters a distal portion 204D of the curved section <NUM> in the capsule receptacle <NUM>.

The distal region 204D of the curved section <NUM> differs from the proximal regions 204P in that the distal region 240D of the curvature are disposed along the longitudinal extent according to the axis <NUM> away from the center wall <NUM>, whereas the proximal regions 204P of the curvature are disposed between the wall <NUM> and the distal region 204D.

An imaginary plane <NUM>, which corresponds to the cross-sectional plane in <FIG>, is defined by the two central longitudinal axes <NUM>. In the imaginary plane <NUM>, the distal region 240D comprises an arc of the semicircle of the curved section <NUM> with an angle AD of about <NUM>° starting from an imaginary center point M. The proximal regions 204P arranged on both sides of the distal region 204D comprise a respective angle AP of about <NUM>° starting from the imaginary center point M. The former aspect can also be applied to the capsule <NUM> to be opened.

The needle tip <NUM> of the respective needle <NUM> is arranged in such a way that it contacts the shell of the capsule <NUM> in its distal region of the hemisphere. In line with the current invention, the needle tip <NUM> is arranged extracentrically and is located on an imaginary cylindrical barrel of the needle <NUM>. The present rotational position of the needle <NUM> determines the needle tip <NUM> in a tip position which faces the other axis <NUM> of the opposite guide section <NUM>. This arrangement ensures that the needle tip <NUM> hits the capsule shell substantially perpendicularly. The more perpendicular the impact direction, the larger the opening in the capsule <NUM>. Nonetheless, the opening in the shell of the capsule <NUM> is created in a distal region of the surface of the hemisphere, the distal region of the hemisphere including an angle of <NUM>° to the center M surrounded by a proximal region of the hemisphere, the proximal region of the hemisphere being arranged in a cross-section lateral to the proximal region and each including an angle of <NUM>° to the center M.

There is illustrated that at least one of the guiding sections <NUM> and the associated needle <NUM> are arranged such that the tip <NUM> of at least one of the needles <NUM> enters the capsule receptacle <NUM> in a distal portion 204D of a curved section <NUM> of the capsule receptacle <NUM>.

The figure is directed to an example in that the guiding sections <NUM> of the base body <NUM> extend in parallel imaginary planes.

The capsule receptacle <NUM> is delimited by two distal curved sections <NUM>, each of which follows a semicircle in perpendicular cross-section to the vertical axis z of the dry powder inhaler <NUM>. The curved sections <NUM> follow a hemisphere at least partly. The two curved sections <NUM> are connected to each other by a wall <NUM> extending parallel to the axis <NUM>. The sections <NUM> and the wall <NUM> form the capsule receptacle <NUM>. The guiding sections <NUM> enter the capsule receptacle <NUM> via an opening <NUM>. A longitudinal axis <NUM> of the guiding section <NUM> coincides with the axis <NUM> of the associated needle <NUM>.

The piercing needles are rotated <NUM>° left with respect to the axis <NUM> in relation to the prior art.

<FIG> depicts a side view of one of the needles <NUM> of the dry powder inhaler <NUM>. The needles <NUM> have a length <NUM>, a needle diameter <NUM> and a cutting tip angle <NUM>. The needle diameter <NUM> is in the range of about <NUM>,<NUM> to about <NUM>,<NUM> wherein the cutting tip angle <NUM> is in the range of about <NUM>° to <NUM>°. A distal part comprises a bevel following the angle <NUM>. Said bevel includes two lateral chamferings meeting at the tip <NUM> to improve the sharpness of the tip <NUM>. The respective distal part of the needle <NUM> is bevel-like or lancet-like.

<FIG> shows a top view of the needle <NUM> of <FIG> when looking into the direction of arrow <NUM> in <FIG>.

<FIG> shows a partial cross-section A-A of the needle <NUM> of <FIG> in a front view when looking into the direction of arrow <NUM> in <FIG>.

The needles <NUM> have lateral cutting edges <NUM> which are arranged in an angle <NUM> in the range of about <NUM> to <NUM>° with respect to an axis <NUM> perpendicular to the longitudinal axis <NUM> of the needle <NUM> and lying in a plane <NUM> parallel to the longitudinal axis <NUM>. The needles <NUM> are symmetrical to a middle plane <NUM>.

The dry powder inhaler <NUM> functions as follows:
In order to insert a dry powder capsule <NUM> into the capsule receptacle <NUM> of the base body <NUM>, the mouthpiece <NUM> can be pivoted into an opening position via the hinge <NUM> as shown in <FIG>. After insertion of the capsule <NUM>, the mouthpiece <NUM> is pivoted back into a closed position as depicted in <FIG> and <FIG>. In order to pierce the capsule <NUM>, the actuator buttons <NUM> are pressed against the force of the helical spring <NUM> into the actuation direction <NUM>.

The cutting tip angle <NUM>, the lateral cutting edges <NUM> and the arrangement of the capsule receptacle <NUM> and the needles <NUM> provide for an accurate cutting of a shell of the capsule <NUM> during piercing of the capsule <NUM> without detaching the cut-out portion from the capsule shell.

<FIG> depicts a schematic view of a pierced capsule <NUM> during inhalation. Cut-out portions <NUM> can be bent inwards into the interior of the capsule <NUM> in a hinged or flap-like manner.

Because of the comparably large needle diameter <NUM>, comparably big openings <NUM> can be pierced into the capsule <NUM> in a transition area of the hemispherical ends <NUM> and the tubular middle section of the capsule <NUM>.

When a patient or user is using the dry powder inhaler <NUM>, a capsule <NUM> arranged in the capsule receptacle <NUM> can be pierced by moving the actuator buttons <NUM> from the normal position into the perforation position. After piercing the capsule <NUM>, the actuator buttons <NUM> are moved back into the normal position. When a patient or user is sucking in air through the inhaling inlet <NUM> of the mouthpiece <NUM>, a partial vacuum in the capsule chamber <NUM> can be generated wherein air is sucked into the capsule chamber <NUM> through the at least one base body air inlet <NUM> generating an air flow that lifts the capsule <NUM> from the capsule receptacle <NUM> into the capsule chamber <NUM> and rotates the capsule <NUM> in the capsule chamber <NUM> in the direction of arrow <NUM> as shown in <FIG> such that dry powder contained in the capsule <NUM> can be dispersed.

When sucking in air on the inhaling inlet <NUM> through the capsule chamber <NUM>, air is directed from the mouthpiece air inlets <NUM> via the base body ducts <NUM> and through the intermediate air chamber <NUM> into the capsule chamber <NUM> via the base body air inlets <NUM>.

Table <NUM> and Table <NUM> shown below show comparative tests of flow resistances of a dry powder inhaler <NUM> having an intermediate air chamber <NUM> and flow resistances of a dry powder inhaler without an intermediate air chamber <NUM>.

By directing the air flow through the intermediate air chamber <NUM>, a dry powder inhaler <NUM> can be provided with less necessary pressure for achieving a certain average flow rate in contrast to a dry powder inhaler which has no intermediate air chamber <NUM>.

Overall, an inhaler <NUM> with an intermediate air chamber <NUM> can be provided that has less flow resistance at regular lung capacities. When a user or patient has less lung capacity of about <NUM>/min, a dry powder inhaler <NUM> can be provided with significantly less flow resistance in comparison to a dry powder inhaler without an intermediate air chamber <NUM>.

Because of the arrangement of the capsule receptacle <NUM> and the needles <NUM>, the capsule <NUM> can be pierced in a position that allows powder to be efficiently dispersed during the rotational movement in an inhalation process while providing little or almost no obstruction to the powder flow.

To sum up, a dry powder inhaler <NUM> is provided which allows for a high dosage inhalation in the range of about <NUM> to about <NUM>.

<FIG> shows internal images of capsule hollow mold portions H1, H2 which can be inserted into one another and which, in the right-hand illustration, have been opened using the dry powder inhaler according to the embodiment shown in <FIG>. That is the views of <FIG> show the internal wall of the hemispherical part of the hollow molds H1, H2.

For comparison purposes, two capsule halves are shown on the left which were opened using a dry powder inhaler according to prior art. The hard capsules consist of two prefabricated cylindrically shaped hollow mold parts H1, H2 with hemispherical ends. In the images shown, perforations have been introduced into both of the hemispherical ends by piercing with a respective needle. It can be clearly seen that the capsule parts shown on the right have larger perforations O1, O2 than the openings Oa, Ob which are achievable by a piercing method according to the prior art. This results in one small and strong flap per per mold part H1, H2, which can be bended back outwards during inhalation preventing the powder to easily exit the capsule. Larger flaps tend to return to its original position of the shell in case of large portions of powder wheight inside the capsule.

In the prior art piercing method, only a single segment Sa, Sb of the hollow molds is created by piercing the capsule hemispheres along a continuous crack border Ca, Cb. The single segment Sa, Sb per hemisphere projects inwards with respect to the shell of the capsule.

The piercing method described in this description provides, in contrast to the prior art method, that the respective piercing needle creates two segments S1a, S1b and S2a, S2b of the shell per hemisphere. Both segments S1a, S1b and S2a, S2b per hemisphere.

The two fold edges of the flaps or segments S1a, S1b and S2a, S2b join at a point towards a central longitudinal axis <NUM> of the capsule. In contrast, a semi-circular shaped crack edge C1, C2, which is part of the respective perforation opening O1, O2, is arranged pointing away from the central longitudinal axis of the capsule. Therefore, the perforation opening O1, O2 is larger and more stable flaps than that provided by the prior art piercing method.

Small strong flaps are created. This construction allows to create even well-cutted triangular-like bent flaps instead of one bigger flap.

In particular, one reason for the larger perforation opening O1, O2 is that the extracentric tip of the piercing needle first hits the capsule at a point, where the crack edge C1, C2 is located afterwards. While entering the hemispherical part of the capsule the piercing needle, the needle cuts the shell of the hemispherical regions oriented towards the axis <NUM> apart into the two segments S1a, S1b or S2a, S2b. By providing two separate segments, the perforation opening tends to be more stable after retraction of the needle.

The below table <NUM> shows results from measurements and reveals how the improvement works in terms of emitted dose. Apparently, there is a better comparative performance, meaning a higher-end dose and less variation between delivered doses DD in percent (DD%) that leaves the capsule and enters the lung.

<FIG> depict an example of the dry powder inhaler <NUM> without the covering body <NUM>. The features are compatible to and combinable with the other examples of the dry powder inhaler <NUM> described before.

The first end <NUM> of each actuator button <NUM> is pivotally attached to the housing <NUM> by use of the ball joint snap-on connection <NUM> pivoting around the pivot axis, wherein the actuator button <NUM> is pivotable around a pivoting angle <NUM> of about <NUM>° to <NUM>°, preferably of about <NUM>°.

The ball joint snap-on connection <NUM> comprises the hemispherical protrusions (not shown in the drawings) arranged on the housing <NUM> and the hemi-spherical recesses <NUM> (shown in <FIG>) arranged on the actuator buttons <NUM>, wherein the protrusions and recesses extend along the pivot axis and wherein the protrusions engage the recesses.

A contour <NUM>, as shown in <FIG>, or second end faces away from the connection <NUM>. The contour <NUM> or second end has the shape of a fin and engages in a guiding contour <NUM>, which is configured, for example, as a groove. The respective second end <NUM> moves along a circular path around the pivot axis. According to another example, the contour or second end <NUM> is a groove and the guiding contour <NUM> of the base body <NUM> is a fin guided in the groove. Of course, the contour does not rely on being arranged on the second or rotating end of the actuator button <NUM>.

The contact surface of the actuator button <NUM>, which is pressed by the user with his hands, is at least partly surrounded by an outwardly facing sealing surface <NUM>. The sealing surface <NUM>, when pressed outwardly by the spring <NUM>, abuts an inwardly facing mating surface of the covering body <NUM>, which is not shown here, thereby reducing the air supply over the edges of the actuator buttons <NUM>. The contour or second end <NUM> is arranged proximal to or flush to the outwardly facing sealing surface <NUM> of the respective actuator button <NUM>.

In other words, the respective actuator button <NUM> comprises a contour, especially the at least one guiding fin, moving along a circular path around the pivot axis, wherein the contour engages in the guiding contour <NUM>, especially a groove, of the base body <NUM>. Advantageously, the base body serves an additional guiding means to maintain a stable guiding of the actuator button <NUM> and the piercing needle <NUM> attached thereto.

<FIG> depicts the base body <NUM>. The hollow needle guiding section <NUM> comprises a through slot <NUM> extending from the exterior of the capsule receptacle <NUM> to the interior of the capsule receptacle <NUM>. The respective needle <NUM> extends through the through slot <NUM>.

Claim 1:
A dry powder inhaler for a capsule (<NUM>) containing dry powder, the inhaler (<NUM>) comprising a base body (<NUM>) having a capsule receptacle (<NUM>), two actuator buttons (<NUM>) arranged on opposing sides of the base body (<NUM>) and two perforation needles (<NUM>), each needle (<NUM>) being fixedly connected to a respective one of the actuator buttons (<NUM>) and movable relative to guiding sections (<NUM>) of the base body (<NUM>) towards each other from a normal position to a perforation position along an actuation direction (<NUM>) to perforate a capsule (<NUM>) arranged in the capsule receptacle (<NUM>), wherein the capsule receptacle (<NUM>) is arranged in an inclined angle (<NUM>) within the range of about <NUM>° to about <NUM>° with respect to the actuation direction (<NUM>), characterized in that at least one of or both of the piercing needles (<NUM>) comprise an extracentric tip (<NUM>) located on an imaginary cylindrical barrel of said needle (<NUM>) and the rotational position of said needle (<NUM>) determines that the needle tip (<NUM>) is in a tip position which faces a longitudinal axis (<NUM>) of the other piercing needle (<NUM>) to ensure that in use the needle tip (<NUM>) of said needle (<NUM>) hits the capsule shell substantially perpendicularly.