Dry powder inhaler

Abstract

The invention provides a dry powder inhaler for a capsule (90) containing dry powder, the inhaler (10) comprising a base body (14) having a capsule container (56), two actuator buttons (24) disposed on opposite sides of the base body (14), and two piercing needles (28), each piercing needle (28) being fixedly connected to a respective one of the actuator buttons (24), the base body (14) is movable relative to a guide portion (70) of the base body (14) from a normal position into a perforation position in an actuation direction (26) towards each other in order to perforate a capsule (90) arranged in a capsule container (56). Wherein the capsule container (56) is arranged at an inclination angle (68) of about 40 DEG to about 50 DEG with respect to the actuation direction (26), characterized in that the eccentric tip (202) of at least one perforating needle faces the longitudinal axis (92) of the other perforating needle (28).

Description

Technical Field

[0001] The present invention relates to a dry powder inhaler for capsules containing dry powder. Background Art

[0002] Such a dry powder inhaler is known, for example, from EP 1 270 034 A1 or US2003 / 0000523. These dry powder inhalers are non-pressurized inhalers normally. The capsule that is arranged in the capsule container of the dry powder inhaler can be perforated by a needle. When the patient inhales air through the suction nozzle, the capsule can be lifted into the capsule chamber from the capsule container and rotated in the capsule chamber. When the capsule rotates, the dry powder contained in the capsule disperses and mixes with air by centrifugal force during rotation, thereby enabling the patient to inhale.

[0003] In order to disperse the dry powder contained in the capsule, the capsule must be pierced with a needle.

[0004] The problem of known single dose dry powder inhaler is that the dosage of powder is limited.When directly piercing the capsule at the hemispherical end of the capsule, the amount of powder dispersed in the suction process is limited, because in the rotary motion process of the capsule, due to the setting of the perforated opening, the dry powder is hindered when flowing out from the perforated opening. This obstruction may be due to the inward bending of the cutout portion of the capsule shell when the perforating needle pierces the capsule. In addition, known dry powder inhaler also has limitations for the maximum dose of dry powder. In some application fields, for example, in the treatment or clinical trials for the diseases such as cystic fibrosis, tuberculosis, pulmonary hypertension, nervous system and congenital diseases, Parkinson's disease, asthma, chronic obstructive pulmonary disease (COPD), it is necessary to contain a high dose of dry powder of about 25mg to about 200mg in one or more capsules.

[0005] Furthermore, known inhalers generally suffer from the problem that the inhalation resistance varies greatly depending on the lung capacity of the user or patient, wherein at typical lung capacities of approximately 60 liters per minute, high inhalation resistances are preferably avoided.

[0006] It is therefore an object of the present invention to provide a cost-effective dry powder inhaler for dispensing dry powders, which can easily handle high doses of dry powders and has low inhalation resistance. Summary of the invention

[0007] The above object is achieved by a dry powder inhaler according to the features of claim 1 .

[0008] One aspect of the present specification relates to the following subject matter: a dry powder inhaler for a capsule containing a dry powder, the inhaler comprising:

[0009] a base body having a capsule container;

[0010] two actuator buttons, the two actuator buttons being disposed on opposite sides of the base; and

[0011] Two piercing needles, each of which is fixedly connected to a corresponding one of the actuator buttons and can be moved from a normal position to a piercing position toward each other along an actuation direction relative to the guide portion of the base to pierce a capsule arranged in the capsule container, wherein the capsule container is arranged at an inclined angle of about 40° to about 50° relative to the actuation direction, characterized in that the eccentric tip of at least one or both of the piercing needles is facing the longitudinal axis of the other piercing needle.

[0012] When using a dry powder inhaler, the eccentric tip and its arrangement form a larger triangular opening when piercing the capsule. This makes it easier for the powder contained in the capsule to be discharged. In this way, the air-powder mixture inhaled by the patient can be improved. Since a larger amount of powder can be safely discharged from the capsule, the variation of the released dose is reduced, so that the drug can be delivered more accurately. Therefore, the accurate dosage of the drug is improved.

[0013] In addition, this perforation method makes the shape and size of the perforation holes more uniform, thus achieving uniformity between different doses of drugs compared to other forms of capsule perforation.

[0014] Since the opening has a unique triangle-like shape with two side portions bent inwards, the cut shape of the opening prevents the capsule from closing inwardly. This is related to the shape of the needle tip and the contact direction with the capsule.

[0015] An advantageous example is characterized in that the eccentric tips of both perforating needles are each oriented toward the longitudinal axis of the other perforating needle.

[0016] Another example is characterized in that when the eccentric tip of at least one perforating needle moves from the normal position to the perforating position along the actuation direction, it passes through an imaginary plane at an angle between 90° and 83°, in particular between 90° and 85°, more particularly between 90° and 88°, which is tangent to the relevant curved portion of the capsule container.

[0017] The eccentric tip of the perforating needle passes through the imaginary plane nearly vertically, which makes the eccentric tip of the perforating needle enter the capsule shell nearly vertically. Through this perforation arrangement, the perforation hole on the capsule will be enlarged.

[0018] Another example is characterized in that a central longitudinal axis of the guide portion enters a distal end portion of the curved portion in the capsule container.

[0019] This arrangement allows the needle to enter the distal portion of the corresponding capsule hemisphere. Therefore, the hole produced in the capsule is located at the distal point, thereby facilitating the release of the powder from the interior of the capsule.

[0020] For example, benefits may be achieved by configuring at least one guide portion and a corresponding perforating needle such that a needle tip of at least one perforating needle enters the capsule container in a distal portion of a curved portion of the capsule container.

[0021] Furthermore, one example is advantageous in that the guide sections of the basic body extend in imaginary parallel planes.

[0022] According to one example of the inhaler, a first end of each actuator button is pivotally attached to the housing.

[0023] Particularly preferably, the first end of each actuator button is connected to the housing by a ball joint snap connection piece pivoted around a pivot axis.By providing a ball joint snap connection piece, the actuator button can be attached to the lower part of the housing by engaging with the ball joint snap connection piece.

[0024] Advantageously, the actuator button is pivotable about a pivot angle of approximately 5° to 15°, preferably approximately 10°.

[0025] In another preferred example of the inhaler, the ball joint snap connection comprises a hemispherical protrusion arranged on the housing and a hemispherical groove complementary to the hemispherical protrusion arranged on the actuator button, wherein the protrusion and the groove extend along the pivot axis. In order to engage with the ball joint snap connection, the hemispherical protrusion is preferably arranged on the housing so that they can be elastically pushed into the release position along the direction of the pivot axis. In the release position, the groove of the actuator button and the protrusion of the housing can overlap so that the protrusion can snap into the groove and elastically return to the engagement position of the ball joint snap connection.

[0026] It is particularly preferred that the piercing needle is arranged in a region where the second free end of each actuator button is spaced apart from the first end of the actuator button. Preferably, the piercing needle is arranged on inner surfaces of the actuator buttons that are opposite to each other. By arranging the piercing needle in the region of the second free end of each actuator button, a larger range of movement can be provided despite the first end of each actuator button being connected to the housing.

[0027] In a particularly preferred example, the dry powder inhaler comprises a spring element acting on the actuator button so that the actuator button is preloaded into a normal position. Preferably, the spring element is a helical spring.

[0028] In another preferred example of the dry powder inhaler, the housing comprises two openings configured to accommodate the actuator button, so that when the actuator button is in the normal position, the outer surface of the housing and the actuator button are substantially flush. It is particularly preferred if the actuator button, in particular its fins on the sides, closes the opening in the housing in a substantially airtight manner in the normal position, so that no or substantially no air can pass between the actuator button and the edge of the opening.

[0029] The dry powder inhaler is characterized in that an intermediate air chamber is formed between the base and the cover, wherein the mouthpiece has an inhalation port connected to the fluid of the capsule chamber, and at least one mouthpiece air inlet arranged outside the mouthpiece and connected to the fluid of the intermediate air chamber, and wherein the base has at least one base air inlet, which is connected to the fluid of the capsule chamber and the intermediate air chamber and terminates in the capsule chamber.

[0030] Preferably, the matrix is ​​connected to the cover so that there is no or substantially no air that can be sucked out from the capsule chamber at the joint surface between the matrix and the cover. Particularly preferably, two actuator buttons are arranged on the opposite side of the cover and can move between the normal position and the perforation position. Advantageously, the actuator button closes the cover in a substantially airtight manner when in the normal position so that there is no or substantially no air that can pass between the actuator button and the opening edge of the opening that is configured to hold the actuator button. Therefore, particularly preferably, when the actuator button was in the normal position, there was substantially no air that could be sucked between the cover and the actuator button. In the preferred example of the dry powder inhaler, at least one matrix air inlet terminates in the capsule chamber tangentially. Preferably, two matrix air inlets are provided. This provides more stable resistance for air flow during inhalation, because a certain amount of air flow will not enter the housing chamber unstably during inhalation.

[0031] When a patient or user uses the dry powder inhaler, the capsule disposed in the capsule chamber can be pierced by moving the actuator button from the normal position to the perforation position in the actuation direction. After piercing the capsule, the actuator button moves back to the normal position. When the patient or user inhales through the inhalation port of the mouthpiece, a partial vacuum can be generated in the capsule chamber, and air can be sucked into the capsule chamber through at least one base air inlet, thereby generating an airflow, which can lift the capsule in the capsule chamber and rotate it in the capsule chamber, thereby dispersing the dry powder contained in the capsule chamber.

[0032] Advantageously, the air sucked into the capsule chamber by at least one matrix air inlet can be guided from the nozzle air inlet and pass through the intermediate air chamber. By guiding the airflow to pass through the intermediate air chamber, the required pressure of the dry powder inhaler can be made smaller when realizing a certain average flow rate.

[0033] According to a preferred example of Diskus, the capsule chamber is cylindrical and comprises a hemispherical end portion with a capsule container. The capsule container can be arranged at an angle relative to the actuation direction of the actuator button. Nevertheless, the capsule container can also be arranged parallel to the actuation direction.

[0034] Preferably, the nozzle comprises a cylindrical protrusion configured to extend at least partially into the capsule chamber.

[0035] In a particularly preferred example of the dry powder inhaler, the cylindrical protrusion of the mouthpiece extends into the capsule chamber, wherein the side surface of the cylindrical protrusion is configured to seal against the inner surface of the capsule chamber. Preferably, the cylindrical protrusion abuts against the inner surface of the capsule chamber so that substantially no air can be sucked out of the capsule chamber between the inner surface of the capsule chamber and the side surface of the cylindrical protrusion.

[0036] In another preferred example of the dry powder inhaler, the substrate comprises at least one substrate conduit, at least one substrate conduit overlaps with the mouthpiece air inlet and is in fluid communication with the mouthpiece air inlet, wherein the substrate conduit is in fluid communication with the intermediate air chamber and terminates in the intermediate air chamber. Preferably, the substrate conduit is an opening on the substrate that overlaps with the mouthpiece air inlet.

[0037] Preferably, the base comprises a cylindrical shoulder, preferably elliptical, and a base plate, preferably elliptical and arranged perpendicularly to the cylindrical shoulder. Preferably, the base plate defines an outer wall of the intermediate air chamber. Advantageously, at least one base duct is an opening in the base plate that overlaps the suction nozzle air inlet, thereby placing the intermediate air chamber in fluid communication with the suction nozzle air inlet.

[0038] In a preferred example of the dry powder inhaler, the capsule chamber is attached to the base plate and the opening leads to the base plate.

[0039] According to a preferred example, the actuator buttons are each capable of pivoting around a pivot axis at a pivot angle of, for example, approximately 5° to 15°, preferably approximately 10°, wherein the actuator buttons each include an outer contour that moves along a circular path around the pivot axis and wherein the outer contour engages with a guide contour of the base body.

[0040] Advantageously, a guide device is provided to achieve a stable and reproducible perforation effect for the released powder.

[0041] According to an advantageous example, the actuator button comprises a sealing surface which at least partially surrounds an outer surface of the actuator and wherein the outer contour engaged in the guide contour of the base body is arranged close to or flush with the outward sealing surface of the corresponding actuator button.

[0042] Advantageously, the guiding function and the sealing function are separated.

[0043] Further details and advantages of the invention can be gathered from the following description, based on which an embodiment of the invention represented in the drawing is described and explained in more detail. BRIEF DESCRIPTION OF THE DRAWINGS

[0044] The accompanying drawings show the following:

[0045] Figure 1 is a side view of a dry powder inhaler according to the present invention;

[0046] Figure 2 for Figure 1 A perspective view of a medium dry powder inhaler;

[0047] Figure 3 for Figure 1 and Figure 2 A cross-sectional view of a portion of a medium dry powder inhaler;

[0048] Figure 4 for Figures 1 to 3 A perspective view of some components of a dry powder inhaler;

[0049] Figure 5 for Figures 1 to 4 A perspective view of a base of a medium dry powder inhaler;

[0050] Figure 6 for Figure 5 A top perspective view of the middle matrix;

[0051] Figure 7 for Figures 1 to 4 A top perspective view of a dry powder inhaler in an open position;

[0052] Figure 8 for Figure 5 and Figure 6 A top view of the middle matrix;

[0053] Fig. 9 A capsule and two piercing needles in a piercing position;

[0054] Fig.10 for Figures 1 to 4 Side view of a piercing needle of a medium dry powder inhaler;

[0055] Fig.11 for Fig.10 A top view of the perforating needle;

[0056] Fig.12 for Fig.10 and Fig.11 A front view of the middle perforating needle;

[0057] Fig.13is a schematic diagram of a capsule that has been punctured during inhalation;

[0058] Fig.14 A comparison diagram of the achieved perforation results and the prior art results;

[0059] Fig.15 It is a partial cross-sectional view of a dry powder inhaler;

[0060] Fig.16 for Fig.15 Close-up of;

[0061] Fig.17 is a side view of a dry powder inhaler;

[0062] Fig.18 for Fig.17 Close-up of

[0063] Fig.19 The view of the base. Specific embodiments

[0064] Figures 1 to 12 A capsule for containing dry powder (such as Fig.13 1. The dry powder inhaler 10 of the present invention is shown in FIG. The dry powder inhaler 10 comprises a housing 12 having a substrate 14 and a cover 16. The dry powder inhaler 10 also comprises a mouthpiece 18. The mouthpiece 18 comprises a mouth 20 having a central opening 22 for inhaling air mixed with the dry powder contained in the capsule disposed in the dry powder inhaler 10.

[0065] The dry powder inhaler 10 includes two actuator buttons 24 disposed on opposite sides of the housing 12, and the two actuator buttons 24 can be moved from a normal position to a perforation position toward each other relative to the housing 12 along an actuation direction indicated by an arrow 26 to perforate a capsule disposed in the dry powder inhaler 10. The housing 12 includes two openings 23, which are configured to accommodate the actuator buttons 24, so that when the actuator buttons 24 are in the normal position, the outer surface 25 of the housing 12 and the actuator buttons 24 are substantially flush.

[0066] Figure 3 Shows Figure 1 and Figure 2 1 is a cross-sectional view of a portion of a dry powder inhaler 10. Each actuator button 24 is connected to the cover body 16, that is, the housing 12, wherein a piercing needle 28 fixedly connected to the actuator button 24 is provided. Figure 3 Only one punch needle 28 is shown in FIG. 1 because the two punch needles 28 are relative to each other. Figure 3 The cutting planes are staggered.

[0067] The first end 30 of each actuator button 24 is connected to the housing 12, i.e., to the cover 16 in the lower part of the housing 12. The piercing needle 28 is arranged in the region of the second free end 32 of the actuator button 24. The second free end 32 is spaced apart from the first end 30. The second free end 32 of the actuator button 24 can be moved from a normal position to a Figure 3 The piercing position shown is such that the tip of the piercing needle 28 moves along a circular trajectory.

[0068] The first end 30 of each actuator button 24 is pivotably connected to the housing 12 using a ball joint snap connection 34 pivoting about a pivot axis, wherein the actuator button can pivot about a pivot angle 36 of about 5° to 15°, preferably about 10°. Thus, when the actuator button 24 is in the piercing position, the piercing needle 28 is inclined at a piercing angle 42 of about 5° to 15°, preferably about 10°, relative to a plane 38 perpendicular to the longitudinal axis 40 of the dry powder inhaler 10.

[0069] The ball joint snap connector 34 includes a hemispherical protrusion (not shown) disposed on the housing 12 and a hemispherical recess 44 ( Figure 4 ), wherein the protrusion and the groove extend along the pivot axis and wherein the protrusion engages with the groove.

[0070] By providing two actuator buttons 24 on opposite sides of the housing 12 and connecting each actuator button 24 to the housing 12 at a lower portion of the housing 12 , the actuator button 24 can be preloaded to a normal position by using only one spring element.

[0071] This spring element Figure 4 It is shown in Figure 4 The dry powder inhaler 10 comprises a coil spring 46 which is arranged in a shell-like spring guide 48 of the base body 12 and acts on the actuator button 24 so that the actuator button 24 is preloaded to a normal position against the direction indicated by the arrow 26 .

[0072] exist Figure 5 and Figure 6 The base body 14 of the integrally formed dry powder inhaler 10 is shown in more detail in FIG. Figure 8 It also shows Figure 5 and Figure 61 is a top view of a base 14 of FIG. The base 14 has an elliptical or oval base plate 50 and an oval cylindrical shoulder 52 extending perpendicularly to the base plate 50 and connected to the base plate 50. The base 14 has a capsule chamber 54, which has a capsule container 56 for containing dry powder capsules and two plate-like members 58 extending downward and substantially parallel to each other. The spring guide 48 is arranged coaxially with the actuation direction 26, wherein the plate-like member 58 is arranged perpendicularly to the actuation direction 26. At the free end of the plate-like member 58, a bearing portion 60 for the actuator button 24 is arranged.

[0073] The capsule chamber 54 opens toward the upper end 62 of the base 14. The capsule chamber 54 has a cylindrical portion 64 and a hemispherical or conical end portion 66, wherein the capsule container 56 is disposed in the hemispherical end portion 66 of the capsule chamber 54. The capsule chamber 54 has a diameter of, for example, about 2500 mm. 3 To about 3000mm 3 The capsule container 56 is disposed perpendicular to the longitudinal axis 40 of the dry powder inhaler 10 .

[0074] In addition, the capsule container 56 is arranged at an angle of inclination 68 in the range of 40° to 50° relative to the actuation direction 26. The base body 14 includes two hollow piercing needle guides 70, which are configured to guide the piercing needles 28 and are arranged perpendicular to the longitudinal axis 40 of the inhaler 10 and terminate at the capsule container 56. These piercing needle guides 70 and the piercing needles 28 are arranged parallel to the actuation direction 26 and are spaced apart by a distance 74 from a median plane 72 of the base body 14. The piercing needles 28 are arranged on opposite sides of the median plane 72.

[0075] According to another embodiment not shown in the figures, the capsule container 56 is not arranged at an inclined angle relative to the actuation direction 26, but parallel to the actuation direction 26. In this case, the perforating needle guide portion 70 and the perforating needle 28 are arranged parallel to the actuation direction 26, but are not spaced apart from the middle plane 72 of the base body 14. With this embodiment, the capsules arranged in the capsule container 56 can be perforated directly at the hemispherical end portion of the capsule.

[0076] The diameter 76 of the cylindrical portion 64 is greater than the length of the capsule container 56. The size of the capsule container 56 corresponds to the size of the capsule, so that the capsule container 56 is only slightly larger than the capsule to ensure that the capsule is retained in the capsule container 56 when the actuator button 24 is pressed and the capsule is pierced by the piercing needle 28. Preferably, the capsule container 56 is configured to accommodate a volume of about 400 mm 3 To about 500mm 3 of capsules.

[0077] Furthermore, the base body 14 has two base body air inlet openings 78 in the region of the cylindrical shoulder 52, which end tangentially in the capsule chamber 54 and are arranged perpendicular to the center plane 72 of the base body 14. The suction nozzle 18 is fixed to the base body 14 via a hinge. The lower part of the hinge is Figure 6 1 and has the reference number 80 . The base body 14 also includes two base body ducts 82 .

[0078] An intermediate air chamber 81 is formed between the base body 14 and the cover body 16 of the housing 12. Figure 7 As shown, the central opening 22 of the nozzle 18 is used as a suction port and is in fluid communication with the capsule chamber 54 through a perforated plate 83. The nozzle 18 has two nozzle air inlets 85 on the lateral outer side of the nozzle, which are in fluid communication with the intermediate air chamber 81.

[0079] The base air inlet 78 is also in fluid communication with the intermediate air chamber 81 and the capsule chamber 54. The base includes two base conduits 87 overlapping and in fluid communication with the nozzle air inlet 85. The base conduits 87 are also in fluid communication with the intermediate air chamber 81 and terminate in the intermediate air chamber 81.

[0080] On the side facing away from the mouth 20, the nozzle 18 includes a cylindrical protrusion 91, which is configured to extend at least partially into the capsule chamber 54. A perforated plate 83 is provided at the end of the cylindrical protrusion 91. The side surface 93 of the cylindrical protrusion 91 is configured to abut against the inner surface 95 of the capsule chamber 54 in a sealing manner, so that substantially no air can pass between the inner surface 95 of the capsule chamber 54 and the side surface 93 of the cylindrical protrusion.

[0081] Figure 8 Shows when along Figure 6 When looking in the direction of arrow 84 Figure 6 1. The capsule container 56 has a longitudinal axis 86 which is arranged at an angle 68 of inclination in the range of about 40° to about 50° relative to the actuation direction 26 or the middle plane 72. The piercing needle 28 pierces the capsule, which can be arranged in the capsule container 56 at an angle 88 relative to the capsule container 56 or the longitudinal axis 86 of the capsule.

[0082] This capsule is 90 Fig. 9 The longitudinal axis 86 of the capsule 90 is disposed at an angle 88 to the longitudinal axis 92 of the piercing needle 28 .

[0083] Fig. 9 A schematic cross section of the base body 14 along the center axis of the guide section 70 is shown.

[0084] The figure relates to a dry powder inhaler 10 for a capsule 90 containing dry powder, the inhaler 10 comprising a base 14 having a capsule container 56, two actuator buttons 24 arranged on opposite sides of the base 14, and two piercing needles 28, each piercing needle 28 being fixedly connected to a corresponding one of the actuator buttons 24 and being movable from a normal position to a piercing position toward each other along an actuation direction 26 relative to a guide portion 70 of the base 14 so as to pierce a capsule 90 arranged in the capsule container 56, wherein the capsule container 56 is arranged at an inclination angle 68 in the range of approximately 40° to approximately 50° relative to the actuation direction 26, and characterized in that an eccentric tip 202 of at least one piercing needle 28 is directed toward the longitudinal axis 92 of the other piercing needle 28.

[0085] The figure depicts the eccentric tips 202 of both piercing needles 28 as being oriented toward the longitudinal axis 92 of the other piercing needle 28 .

[0086] It is shown that when at least one piercing needle 28 moves between the normal position and the piercing position along the actuation direction 26, its eccentric tip 202 passes through an imaginary plane 212 at an angle between 90° and 83°, in particular between 90° and 85°, and in particular between 90° and 88°, which is tangential to the associated curved portion 204 of the capsule container 56. In other words, the movement axis of the piercing needle 28 passes through the imaginary plane 210 vertically or nearly vertically.

[0087] In the section shown perpendicular to the vertical axis z, an imaginary plane 210 rests against the curved portion 204 and passes through the edge of the opening 208 , which edge faces the axis 210 of the opposite guide portion 70 .

[0088] As shown in the figure, the central longitudinal axis 204 of the guide portion 210 enters the distal portion 204D of the curved portion 204 in the capsule container 56.

[0089] The difference between the distal portion 204D and the proximal portion 204P of the curved portion 204 is that the distal portion 204D of the curved portion is arranged away from the central wall 206 along the longitudinal extension direction according to the axis 86, while the proximal portion 204P of the curved portion is arranged between the central wall 206 and the distal portion 204D.

[0090] and Fig. 9 The imaginary plane 220 corresponding to the cross-sectional plane in FIG. 2 is defined by the two central longitudinal axes 210. In the imaginary plane 220, the distal portion 240D includes an arc of a semicircle of the curved portion 204, and the angle AD formed by the arc starting from the imaginary center point M is about 90°. The proximal portions 204P disposed on both sides of the distal portion 204D each form an angle AP of about 45° starting from the imaginary center point M. The above situation also applies to the capsule 90 to be opened.

[0091] The eccentric tip 202 of each piercing needle 28 is arranged in such a way that it contacts the shell of the capsule 90 at the distal end of the hemisphere of the capsule 90. The eccentric tip 102 is arranged eccentrically and is located on an imaginary cylindrical barrel of the piercing needle 28. The current rotational position of the piercing needle 28 determines that the eccentric tip 102 is at the tip position of the other axis 92 facing the opposite guide portion 70. This arrangement ensures that the eccentric tip 202 penetrates the capsule shell substantially vertically. The more vertical the penetration direction, the larger the opening on the capsule 90. Nevertheless, the opening on the shell of the capsule 90 is formed at the distal end of the hemisphere surface, the distal end of the hemisphere includes an angle of 90° relative to the center M surrounded by the proximal part of the hemisphere, and the proximal part of the hemisphere is arranged in a cross section on the side of the proximal part, and each is at an angle of 45° relative to the center M.

[0092] As shown in the figure, at least one guide portion 70 and the associated piercing needle 28 are arranged so that the eccentric tip 202 of the at least one piercing needle 28 enters the capsule container 56 at the distal portion 204D of the curved portion 204 of the capsule container 56.

[0093] This figure relates to an example in which the guide portion 70 of the base body 14 extends in parallel imaginary planes.

[0094] Capsule container 56 is limited by two distal curved portions 204, and each curved portion is semicircular on the cross section perpendicular to the vertical axis z of Diskus 10.Curved portion 204 is hemispherical at least in part.Two curved portions 204 are connected to each other by a center wall 206 extending parallel to axis 86.Curved portion 204 and center wall 206 have formed capsule container 56.Guiding portion 70 enters capsule container 56 through opening 208.The longitudinal axis 210 of guiding portion 70 overlaps with the longitudinal axis 92 of relevant piercing needle 28.

[0095] Compared with the prior art, the perforating needle is rotated 90° to the left relative to the longitudinal axis 210 .

[0096] Fig.10 A side view of a piercing needle 28 of a dry powder inhaler 10 is depicted. The piercing needle 28 has a length 92, a piercing needle diameter 94, and a cutting tip angle 96. The piercing needle diameter 94 is about 1.10 to about 1.95 mm, and the cutting tip angle 96 is about 20 ° to 40 °. The distal portion includes a bevel along the cutting tip angle 96. The bevel includes two side chamfers that intersect at the eccentric tip 202 to improve the sharpness of the eccentric tip 202. The corresponding distal portion of the piercing needle 28 is beveled or lancet-shaped.

[0097] Fig.11 Shown along Fig.10 Observe in the direction of arrow 98 Fig.10 A top view of the punch needle 28.

[0098] Fig.12 Shown along Fig.11 Observe in the direction of arrow 100 Fig.10 and Fig.11 A front view of a partial cross section AA of the punch needle 28.

[0099] Punch needle 28 has lateral cutting edges 102 disposed at an angle 104 of about 25° to 35° relative to an axis 106 perpendicular to longitudinal axis 92 of punch needle 28 and lying in a plane 108 parallel to longitudinal axis 92. Punch needle 28 is symmetrical relative to median plane 110.

[0100] The working principle of dry powder inhaler 10 is as follows:

[0101] To insert the dry powder capsule 90 into the capsule receptacle 56 of the base 14, the dry powder capsule 90 can be inserted into the capsule receptacle 56 by Figure 7 The hinge 80 shown pivots the nozzle 18 to the open position. After the capsule 90 is inserted, the nozzle 18 is pivoted back to the closed position. Figure 1 and Figure 2 In order to pierce the capsule 90 , the actuator button 24 needs to be pressed along the actuation direction 26 against the force of the coil spring 46 .

[0102] The cutting tip angle 96, the lateral cutting edge 102, and the arrangement of the capsule container 56 and the piercing needle 28 enable the shell of the capsule 90 to be accurately cut during the piercing of the capsule 90 without causing the cut portion to separate from the capsule shell.

[0103] Fig.13 A schematic diagram of the capsule 90 which has been punctured during inhalation is depicted. The cutout portion 112 may be folded inwardly to the interior of the capsule 90 in a hinged or flap-like manner.

[0104] Since the piercing needle diameter 94 is relatively large, a relatively large opening 114 can be formed by piercing the capsule 90 in the transition area between the hemispherical end 116 and the tubular middle portion of the capsule 90 .

[0105] When the patient or user uses the dry powder inhaler 10, the capsule 90 disposed in the capsule container 56 can be pierced by moving the actuator button 24 from the normal position to the perforation position. After piercing the capsule 90, the actuator button 24 moves back to the normal position. When the patient or user inhales air through the inhalation port 22 of the mouthpiece 18, a partial vacuum can be generated in the capsule chamber 54, and air can be sucked into the capsule chamber 54 through at least one substrate air inlet 78, thereby generating an air flow, which can lift the capsule 90 from the capsule container 56 into the capsule chamber 54 and cause the capsule 90 to move along the capsule chamber 54. Fig.13 The capsule 90 is rotated in the direction indicated by the arrow 118, thereby dispersing the dry powder contained in the capsule 90.

[0106] When air is sucked through the capsule chamber 54 at the suction port 22 , the air enters the capsule chamber 54 from the suction nozzle air inlet 85 through the base duct 87 , and through the intermediate air chamber 81 , and then through the base air inlet 78 .

[0107] Tables 1 and 2 shown below show a comparative test of the airflow resistance of the dry powder inhaler 10 with the intermediate air chamber 81 and the airflow resistance of the dry powder inhaler without the intermediate air chamber 81 .

[0108] Table 1: Airflow resistance at different air flow rates

[0109]

[0110] Table 2: Airflow resistance at different air flow rates

[0111]

[0112] Compared with a dry powder inhaler without the intermediate air chamber 81 , by directing the air flow through the intermediate air chamber 81 , the dry powder inhaler 10 requires less pressure to achieve a certain average flow rate.

[0113] In general, an inhaler 10 with an intermediate air chamber 81 can be provided, which has a smaller airflow resistance under normal vital capacity. When the vital capacity of the user or patient is low, about 60 liters / minute, the airflow resistance of the dry powder inhaler 10 with the intermediate air chamber 81 is significantly smaller than that of the dry powder inhaler without the intermediate air chamber 81.

[0114] Due to the arrangement of the capsule container 56 and the piercing needle 28, the capsule 90 can be pierced at a specific location that allows the powder to be effectively dispersed during the rotational motion during the inhalation process, while having little or no obstruction to the flow of the powder.

[0115] In summary, a dry powder inhaler 10 is provided that enables high dose inhalation in the range of about 25 mg to about 200 mg.

[0116] Fig.14 The internal image of the hollow mold parts H1 and H2 of the capsule is shown, which can be nested in each other and in the illustration on the right, which is based on Figure 7 The dry powder inhaler of the embodiment shown is opened. That is, Fig.15 The view of shows the inner wall of the hemispherical part of the hollow molds H1, H2.

[0117] For comparison, two capsule halves opened using a dry powder inhaler of the prior art are shown on the left. The hard capsule consists of two prefabricated cylindrical hollow mold parts H1, H2, which have hemispherical ends. In the image shown, perforations are formed by perforating the two hemispherical ends with corresponding perforators. It can be clearly seen that the capsule parts shown on the right have perforations O1, O2 that are larger than the openings Oa, Ob that can be formed by the perforation method of the prior art. This results in a small and solid flap being formed on each mold part H1, H2, which can be bent outward during the inhalation process, thereby preventing the powder from being easily discharged from the capsule. If the weight of the powder inside the capsule is large, the larger flap tends to return to its original position on the capsule shell.

[0118] In the perforation method of the prior art, by perforating the capsule hemisphere along the continuous crack edges Ca, Cb, only a single piece Sa, Sb is formed on the hollow mold. The single piece Sa, Sb on each hemisphere protrudes inwardly relative to the capsule shell.

[0119] Compared with the prior art method, the perforation method described in this specification is that the corresponding perforation needle forms two pieces S1a, S1b and S2a, S2b of the shell on each hemisphere. There are two pieces S1a, S1b and S2a, S2b on each hemisphere.

[0120] The two folded edges of the flaps or sheets S1a, S1b and S2a, S2b meet at a point facing the central longitudinal axis 86 of the capsule. In contrast, the semicircular crack edges C1, C2, which are part of the corresponding perforated openings O1, O2, are arranged to face away from the central longitudinal axis of the capsule. Therefore, the perforated openings O1, O2 are larger than the openings formed by the perforation methods of the prior art, and the flaps are more stable. A small and strong flap is formed. This structure can form a well-cut triangle-like bent flap instead of a large flap.

[0121] In particular, one reason for the larger perforation openings O1, O2 is that the eccentric tip of the perforation needle first penetrates the capsule at one point, followed by the formation of the slit edges C1, C2. When the perforation needle enters the hemispherical portion of the capsule, the perforation needle cuts the shell of the hemispherical region toward the axis 86 into two pieces S1a, S1b or S2a, S2b. By providing two separate pieces, the perforation opening tends to be more stable after the perforation needle is retracted.

[0122] Table 3 below shows the results of the measurements and reveals the effect of this improvement in terms of released dose. Clearly, it has a better comparative performance, meaning a higher final dose and a smaller percentage variation (DD%) between the delivered dose DD leaving the capsule and entering the lungs.

[0123] Table 3

[0124]

[0125] Figures 15 to 17 One example of a dry powder inhaler 10 is shown without a cover 16. These features are compatible and combinable with other examples of dry powder inhalers 10 described previously.

[0126] A first end 30 of each actuator button 24 is pivotably connected to the housing 12 via a ball joint snap connection 34 pivoting about a pivot axis, wherein the actuator button 4 is pivotable about a pivot angle 36 of approximately 5° to 15°, preferably approximately 10°.

[0127] The ball joint snap connector 34 includes a hemispherical protrusion (not shown) disposed on the housing 12 and a hemispherical recess 44 (not shown) disposed on the actuator button 24. Fig.15 ), wherein the protrusions and recesses extend along the pivot axis and the protrusions engage with the recesses.

[0128] like Fig.18 As shown, the outer contour 150 or the second end faces away from the connecting piece 24. The outer contour 150 or the second end is fin-shaped and engages with a guide contour 152, which is configured as a groove, for example. The corresponding second end 150 moves along a circular path around the pivot axis. According to another example, the outer contour or the second end 150 is a groove, and the guide contour 152 of the base 14 is a guide fin in the groove. Of course, this contour is not necessarily provided on the second end or the rotating end of the actuator button 24.

[0129] The contact surface of the actuator button 24 that is pressed by the user's hand is at least partially surrounded by the outwardly facing sealing surface 160. When the sealing surface 160 is pressed outwardly by the spring 46, it abuts against the inwardly facing mating surface (not shown here) of the cover body 16, thereby reducing the air supply through the edge of the actuator button 24. The outer contour or second end 150 is arranged close to or flush with the outwardly facing sealing surface 160 of the corresponding actuator button 24.

[0130] In other words, each actuator button 24 comprises a profile, in particular at least one guide fin, which moves along a circular path around the pivot axis, wherein the profile engages with a guide profile 152, in particular a groove, of the base body 14. Advantageously, the base body serves as an additional guide to maintain a stable guidance of the actuator button 24 and the piercing needle 28 connected thereto.

[0131] Fig.19 The base 14 is shown. The hollow piercing needle guide portion 70 includes a through slot 180 extending from the outside of the capsule container 56 to the inside of the capsule container 56. The corresponding piercing needle 28 extends through the through slot 180.

[0132] The through slot 180 has a larger dimension in a direction parallel to the longitudinal axis 40 than in a plane perpendicular to the longitudinal axis 40. This enables the piercing needle, in particular its tip, to move along a circular path toward the capsule to be opened. When in contact with the capsule, the capsule is pressed down into the capsule container 56 and fixed in place, and its shell is pierced due to the rotation of the piercing needle tip.

Claims

1. A dry powder inhaler for a capsule (90) containing a dry powder, the inhaler (10) comprising: A base body (14), the base body (14) having a capsule container (56); two actuator buttons (24), the two actuator buttons (24) being disposed on opposite sides of the base (14); and Two piercing needles (28), each of which is fixedly connected to a corresponding one of the actuator buttons (24) and can be moved from a normal position to a piercing position toward each other along an actuation direction (26) relative to a guide portion (70) of the base (14) to pierce a capsule (90) arranged in the capsule container (56), wherein the capsule container (56) is arranged at an inclination angle (68) of about 40° to about 50° relative to the actuation direction (26), characterized in that the eccentric tip (202) of at least one or both of the piercing needles (28) is directed toward the longitudinal axis (92) of the other piercing needle (28).

2. The dry powder inhaler according to claim 1, wherein: The eccentric tips (202) of the two piercing needles (28) are both oriented toward the longitudinal axis (92) of the other piercing needle (28).

3. The dry powder inhaler according to claim 1 or 2, wherein: The eccentric tip (202) of at least one of the piercing needles (28) passes through an imaginary plane (212) tangential to the associated curved portion (204) of the capsule container (56) at an angle between 90° and 83°, in particular between 90° and 85°, more in particular between 90° and 88°, when moving from a normal position to a piercing position along the actuation direction (26).

4. The dry powder inhaler according to any one of claims 1 to 3, wherein: The central longitudinal axis (204) of the guide portion (210) enters the distal end portion (204D) of the curved portion (204) in the capsule container (56).

5. The dry powder inhaler according to any one of claims 1 to 4, wherein: At least one of the guide portions (70) and the associated piercing needle (28) are arranged so that the eccentric tip (202) of at least one of the piercing needles (28) enters the capsule container (56) in a distal portion (204D) of a curved portion (204) of the capsule container (56).

6. The dry powder inhaler according to any one of claims 1 to 5, wherein: The guide portions (70) of the base body (14) extend in parallel in parallel planes.

7. The dry powder inhaler according to any one of claims 1 to 6, wherein the inhaler (10) comprises: Capsule room (54); a cover (16), the cover (16) being connected to the base (14); and A suction nozzle (18) covers the capsule chamber (54) and is operable to suck air through the capsule chamber (54), wherein the suction nozzle (18) has a suction port (22) in fluid communication with the capsule chamber (54).

8. The dry powder inhaler (10) according to any one of claims 1 to 7, wherein: The capsule chamber (54) is cylindrical and includes an at least partially hemispherical end portion (66) having the capsule receptacle (56).

9. The dry powder inhaler (10) according to any one of claims 1 to 8, wherein: The nozzle (18) includes a cylindrical protrusion (91) configured to extend at least partially into the capsule chamber (54).

10. The dry powder inhaler according to claim 8 and 9, wherein: The cylindrical protrusion (91) of the suction nozzle (18) extends into the capsule chamber (54), wherein a side surface (93) of the cylindrical protrusion is configured to sealingly abut against an inner surface (95) of the capsule chamber (54).

11. The dry powder inhaler (10) according to any one of claims 1 to 10, wherein: The base (14) includes at least one base duct (87), which overlaps with the suction nozzle air inlet (85) and is fluidly connected to the suction nozzle air inlet (85), wherein the base duct (87) is fluidly connected to the intermediate air chamber (81) and terminates in the intermediate air chamber (81).

12. The dry powder inhaler (10) according to any one of claims 1 to 11, wherein: The base (14) includes a cylindrical shoulder (52) and a base plate (50) arranged perpendicular to the cylindrical shoulder (52).

13. The dry powder inhaler (10) according to any one of claims 1 to 12, wherein: The capsule chamber (54) is attached to the base plate (50) and opens to the base plate (50).

14. A dry powder inhaler (10) according to any one of the preceding claims, wherein When the eccentric tip (202) of the at least one perforating needle (28) pierces a certain point of the capsule, a crack edge (C1, C2) of a perforated opening (O1, O2) is subsequently formed at the point, and wherein, when the at least one perforating needle (28) further pierces the corresponding hemispherical part of the capsule (90), the shell of the corresponding hemispherical part is broken into at least two pieces (S1a, S1b; S2a, S2b).

15. A dry powder inhaler (10) according to any one of the preceding claims, wherein: The respective distal end portion of the piercing needle (28) is beveled and / or lancet-shaped.

16. A dry powder inhaler (10) according to any one of the preceding claims, wherein Each of the actuator buttons (24) is capable of pivoting around a pivot axis at a pivot angle (36) of, for example, approximately 5° to 15°, preferably approximately 10°, wherein each of the actuator buttons (24) comprises an outer contour moving along a circular path around the pivot axis, in particular at least one guide fin, and wherein the outer contour engages in a guide contour (152), in particular a groove, of the base body (14).

17. A dry powder inhaler (10) according to any preceding claim, wherein: The actuator button (24) comprises a sealing surface (160) which at least partially surrounds an outer surface of the actuator, and wherein the outer contour engaged in the guide contour (150) of the base body (14) is arranged to be close to or flush with the outward sealing surface (160) of the corresponding actuator button (24).

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