Novel pulmonary drug delivery system

Abstract

The present application provides a new type of pulmonary drug delivery system, by setting multiple parallel arranged capsule chambers for a capsule type dry powder inhalation device, a drug dispenser containing each active component or mixture thereof of a combination product in a separated way is provided, which is simple in structure and convenient to operate. In addition, the parameters of the air inlet channel and the air outlet channel can be adjusted according to the properties of the powder of the drug or its composition, so as to set the suitable mist particle distribution for each active component.

Description

TECHNICAL FIELD

[0001] The present invention belongs to the field of medical devices, and relates to a novel pulmonary drug delivery system, in particular to a capsule-based dry powder inhaler. BACKGROUND

[0002] The use of dry powder inhalers (DPI) in bronchodilator therapy is well known, which are generally driven by the inspiratory flow of the patient and disperse the drug into an inhalable powder by aerodynamic means.

[0003] Capsule-based dry powder inhalers are a known type of dry powder inhaler, which comprise a capsule chamber and an actuation portion for opening the capsule chamber, the opening of the capsule is mainly achieved by shearing force, needle piercing or cutting, among which needle piercing is the most common opening mechanism, such as the capsule-based inhaler disclosed in US 8196578 B2.

[0004] For the capsule-based DPI with needle piercing mechanism, the powder contained in the capsule is released through the needle piercing hole of the capsule during atomization, when the patient inhales to generate sufficient flow, the capsule starts to rotate and vibrate in the capsule chamber, as the inspiratory flow increases, the rotation speed of the capsule will increase, thereby generating sufficient centrifugal force to release the powder from the capsule. Therefore, the capsule-based DPI also has the problem of insufficient inspiratory flow for patients whose ability to generate sufficient inspiratory flow is impaired, and is generally not recommended for children under 5 years old and patients with partially impaired respiratory function.

[0005] In addition, combination therapy involving different and complementary active drugs is also known, and currently, not only combinations of two, but even three, four active drugs have emerged. Although combination products provide additional convenience for patients, certain drug actives are difficult to formulate into unique combination products. For example, when formulated together, the actives can interact with each other chemically to produce a negative effect.

[0006] The applicant found that a capsule-based dry powder inhaler provides an effective solution to the above problems, which comprises at least two capsule chambers and an actuation portion matched with the number of capsule chambers, each capsule chamber is loaded with capsules containing different drug actives, and by mixing the drug powder released from the capsules in each capsule chamber, a combination inhalation drug product can be provided for administration to patients. SUMMARY

[0007] In one aspect, the present invention provides a powder release device for inhalation administration, comprising:

[0008] a capsule chamber, which is a cylindrical chamber capable of upright accommodating a capsule, the top of the capsule chamber being open;

[0009] an actuating portion comprising a lancet needle mounted to be movable towards the capsule chamber side wall to puncture the capsule, at least a portion of the actuating portion being located outside the device for manipulation by the user;

[0010] a mouthpiece extending from top to bottom with one air outlet channel, a mesh cover being fixed at the bottom opening of the air outlet channel, the mesh cover having a mesh embedded therein and being detachably connected to the top of the capsule chamber so that the mesh covers the top of the capsule chamber;

[0011] wherein the capsule chamber is provided with a set of deflection air inlet channels at its bottom and / or side wall, the set of deflection air inlet channels comprising at least two deflection air inlet channels arranged around the central axis of the capsule chamber and synchronously deflecting in the clockwise or counterclockwise direction to provide a spiral air flow upward from the deflection air inlet channels when the user inhales.

[0012] Preferably, the lower side of the mesh is protruded towards the capsule chamber.

[0013] Preferably, the bottom of the capsule chamber is provided with an air inlet channel opening upward and communicating with the ambient air to provide an air flow from bottom to top.

[0014] Further preferably, the air inlet channel at the bottom of the capsule chamber is opening upward along the central axis of the capsule chamber.

[0015] Further preferably, the air inlet channel at the bottom of the capsule chamber is a set of deflection air inlet channels.

[0016] Further preferably, the set of deflection air inlet channels is arranged as a fixed impeller structure at the bottom.

[0017] Further preferably, the openings of the deflection air inlet channels are tangential to the side wall of the capsule chamber.

[0018] Preferably, the side wall of the capsule chamber is provided with a set of deflection air inlet channels.

[0019] Further preferably, the lower part of the side wall of the capsule chamber is provided with a set of deflection air inlet channels.

[0020] Further preferably, the openings of the deflection air inlet channels are tangential to the side wall of the capsule chamber.

[0021] Preferably, the lower part of the side wall of the capsule chamber is provided with a set of deflection air inlet channels comprising two deflection air inlet channels, and the bottom of the capsule chamber is provided with a straight air inlet channel.

[0022] Preferably, the capsule chamber has a diameter of 1.1 to 2.5 times the diameter of the capsule and a height of 1.02 to 2.0 times the height of the capsule.

[0023] Further preferably, the diameter of the capsule chamber is 1.2 to 1.5 times the diameter of the capsule, and the height of the capsule chamber is 1.05 to 1.3 times the height of the capsule.

[0024] In a specific embodiment of the present application, the diameter of the capsule chamber is 1.35 times the diameter of the capsule, and the height of the capsule chamber is 1.15 times the height of the capsule.

[0025] Preferably, the side wall of the capsule chamber is provided with a first set of deflection air inlet channels, and the bottom of the capsule chamber is provided with a second set of deflection air inlet channels.

[0026] In another aspect, the present application provides a method for releasing inhalable powder in a capsule by using the powder releasing device as described above.

[0027] The powder releasing device of the present application provides a spiral air flow by setting deflection air inlet channels in the capsule chamber when a user inhales, reduces the start-up flow rate of capsule rotation, and enables a user to provide a lower inhalation flow rate to rotate the capsule at a high speed, thereby providing a way for children under 5 years old and patients with impaired respiratory function to use a capsule-type DPI.

[0028] The third aspect of the present application provides a dry powder inhalation device, comprising:

[0029] a capsule chamber, which is a cylindrical chamber capable of vertically accommodating a capsule, the top of the capsule chamber being open, and the bottom and / or side wall of the capsule chamber being provided with air inlet channels communicating with the outside air;

[0030] an actuating part, which comprises a piercing needle and is installed to be movable by a user to the side wall of the capsule chamber to pierce the capsule;

[0031] a mouthpiece, which comprises an air outlet channel below;

[0032] wherein the number of capsule chambers is two to four, all the capsule chambers are arranged in parallel as a one-piece multi-capsule chamber, and the actuating part is provided separately or commonly between the capsule chambers, the actuating part is provided with at least as many piercing needles as the number of the capsule chambers in the width direction, a screen cover is fixed at the bottom of the air outlet channel below the mouthpiece, a screen is fixed in the screen cover, and the screen cover is detachably connected to the top of the multi-capsule chamber so that the screen covers the top of all the capsule chambers.

[0033] Preferably, the side wall of the air outlet channel is provided with at least one small hole communicating with the outside air, and the small hole is opened in a direction not towards the central axis of the air outlet channel to promote the rotation of the air flow in the air outlet channel when a user inhales.

[0034] Preferably, the air outlet channel gradually decreases in diameter from bottom to top to form a narrow neck before reaching the mouthpiece, and the small hole of the air outlet channel is provided on the lower side of the narrow neck.

[0035] Further preferably, the side wall of the air outlet channel has two holes, which are symmetrically arranged around the central axis of the air outlet channel.

[0036] Preferably, the bottom of each capsule chamber is provided with an air inlet channel to provide air flow from bottom to top when the user inhales.

[0037] Further preferably, the air inlet channel of the bottom of the capsule chamber is a deflected air inlet channel group, which comprises at least two deflected air inlet channels arranged around the central axis of the capsule chamber and synchronously deflected in the clockwise or counterclockwise direction to provide a spiral air flow from bottom to top when the user inhales.

[0038] In a specific embodiment of the present application, the deflected air inlet channels of the bottom of each capsule chamber are arranged as a fixed impeller structure as a whole.

[0039] Preferably, the side wall of each capsule chamber is provided with a deflected air inlet channel group, which comprises at least two deflected air inlet channels arranged around the central axis of the capsule chamber and synchronously deflected in the clockwise or counterclockwise direction to provide a spiral air flow from the deflected air inlet channel upward when the user inhales.

[0040] Further preferably, the deflected air inlet channel group is arranged at the lower part of the side wall of the capsule chamber.

[0041] Further preferably, the opening direction of the deflected air inlet channel is tangent to the side wall of the capsule chamber.

[0042] Further preferably, the number of deflected air inlet channels of the deflected air inlet channel group is two.

[0043] Preferably, the size of the air inlet channel and / or the top opening of at least one capsule chamber is different from those of other capsule chambers, so that the air flow rate in the capsule chamber is different from those of other capsule chambers.

[0044] Further preferably, the aperture of the air inlet channel of at least one capsule chamber is different from those of other capsule chambers, so that the air flow rate in the capsule chamber is different from those of other capsule chambers.

[0045] Preferably, the diameter of the capsule chamber is 1.1 to 2.5 times the diameter of the capsule, and the height of the capsule chamber is 1.02 to 2.0 times the height of the capsule.

[0046] Further preferably, the diameter of the capsule chamber is 1.2 to 1.5 times the diameter of the capsule, and the height of the capsule chamber is 1.05 to 1.3 times the height of the capsule.

[0047] In a specific embodiment of the present application, the diameter of the capsule chamber is 1.35 times the diameter of the capsule, and the height of the capsule chamber is 1.15 times the height of the capsule.

[0048] Preferably, the multi-capsule chamber is formed by closely arranged first and second capsule chambers, and a first actuating part and a second actuating part are arranged at both ends of the line on which the first and second capsule chambers are located, and the first and second actuating parts can move from both sides to the middle to respectively pierce the capsules in the first and second capsule chambers.

[0049] Preferably, the multi-capsule chamber is formed by closely arranged first and second capsule chambers, and an actuating part is arranged at one side of the line on which the first and second capsule chambers are located, and the actuating part includes at least two piercing needles in the width direction to simultaneously pierce the capsules in the first and second capsule chambers.

[0050] Further preferably, the air resistance value of the dry powder inhalation device is 0.01-0.08 KPa 0.5 min / L.

[0051] Still further preferably, the air resistance value of the dry powder inhalation device is 0.02-0.05 KPa 0.5 min / L.

[0052] In a specific embodiment of the present application, the air resistance value of the dry powder inhalation device is 0.0325 KPa 0.5 min / L.

[0053] Preferably, the multi-capsule chamber is formed by closely arranged first, second and third capsule chambers in a triangle, a first actuating part is arranged at one side of the line on which the first and second capsule chambers are located, the first actuating part is arranged with at least two piercing needles in the width direction and can move to the multi-capsule chamber to simultaneously pierce the capsules in the first and second capsule chambers, and a third actuating part is arranged at the side of the third capsule chamber away from the first and second capsule chambers and can move in the direction perpendicular to the line on which the first and second capsule chambers are located to pierce the capsules in the third capsule chamber.

[0054] Further preferably, the air resistance value of the dry powder inhalation device is 0.015-0.073 KPa 0.5 min / L.

[0055] Still further preferably, the air resistance value of the dry powder inhalation device is 0.02-0.04 KPa 0.5 min / L.

[0056] In a specific embodiment of the present application, the air resistance value of the dry powder inhalation device is 0.0305 KPa 0.5 min / L.

[0057] Preferably, the plurality of capsule chambers are arranged in a square shape by a first capsule chamber, a second capsule chamber, a third capsule chamber and a fourth capsule chamber, the first actuating part and the second actuating part are arranged on the central axis of the square and are movable from both sides to the middle, the first actuating part and the second actuating part comprise at least two piercing needles in the width direction, so that the first actuating part pierces capsules in the first capsule chamber and the second capsule chamber at the same time, and the second actuating part pierces capsules in the third capsule chamber and the fourth capsule chamber at the same time.

[0058] Further preferably, the air resistance value of the dry powder inhalation device is 0.01-0.06 KPa 0.5 min / L.

[0059] Still further preferably, the air resistance value of the dry powder inhalation device is 0.015-0.035 KPa 0.5 min / L.

[0060] In a specific embodiment of the present application, the air resistance value of the dry powder inhalation device is 0.029 KPa 0.5 min / L.

[0061] Preferably, the dry powder inhalation device further comprises:

[0062] a lower shell defining a cavity open at the top and capable of fixing the plurality of capsule chambers, the lower shell being provided with notches on the side matching the number and position of the actuating parts, so that at least a part of each actuating part is located outside the device for the user to operate, and being provided with air inlets on the side and / or bottom for the internal cavity to communicate with the outside air through slits or holes;

[0063] a linking plate covering the top of the lower shell and being provided with a hollow linking interface at the top of the plurality of capsule chambers, the screen cover being detachably mounted to the linking interface, so that the screen covers the top of each capsule chamber through the linking interface.

[0064] an upper shell extending downward from the top of the suction nozzle and defining a cavity open at the bottom surrounding the air outlet channel, and covering the linking plate when the screen cover is mounted to the linking interface.

[0065] Preferably, the notches are widened and / or lengthened relative to the size of the actuating parts to provide air inlets.

[0066] Preferably, the side wall of the air outlet channel is provided with at least one small hole communicating with the outside air, the small hole being opened in a direction not towards the central axis of the air outlet channel to promote the rotation of the airflow in the air outlet channel when the user inhales.

[0067] Preferably, the upper shell, the lower shell and the linking plate are connected together in a hinged manner through a rotating shaft located on the same side.

[0068] Preferably, the adapter plate is integrally formed with the capsule chamber, and the adapter port constitutes the top opening of each capsule chamber.

[0069] Preferably, the air outlet channel has a gradually decreasing diameter from bottom to top, forming a narrow neck portion before reaching the mouthpiece.

[0070] Preferably, the joint between the upper shell and the adapter plate is provided with a slit or hole, so that the internal cavity can be in communication with the external air through the slit or hole.

[0071] Further preferably, the air outlet channel has two holes, which are symmetrically arranged around the central axis of the air outlet channel.

[0072] Further preferably, the holes on the air outlet channel are located below the narrow neck portion.

[0073] The dry powder inhalation device of the present application provides a medicine dispenser containing each active component (or mixture thereof) of a combination product in a separate manner by arranging multiple capsule chambers in parallel, which is simple in structure and convenient to operate. In addition, the parameters of the air inlet channel and the air outlet channel can be adjusted according to the properties of the powder of the medicine (combination), so as to set the appropriate particle distribution for each active component. BRIEF DESCRIPTION OF DRAWINGS

[0074] Figure 1 A structural exploded view of a powder release device of the present application is shown

[0075] Figure 2 A cross-sectional view of a capsule chamber region of the powder release device is shown Figure 1

[0076] A cross-sectional view of another capsule chamber region of the powder release device is shown Figure 3 Figure 2 A cross-sectional view of another capsule chamber region of the powder release device is shown

[0077] Figure 4 Figure 1 A cross-sectional view of another capsule chamber region of the powder release device is shown

[0078] Figure 5 A cross-sectional view of another capsule chamber region of the powder release device is shown Figure 4

[0079] A cross-sectional view of another capsule chamber region of the powder release device is shown Figure 6 Figure 1 A cross-sectional view of another capsule chamber region of the powder release device is shown

[0080] Figure 7 Figure 6 A cross-sectional view of another capsule chamber region of the powder release device is shown

[0081] ​​​​Figure 8 shown is Figure 1 A cross-sectional view of a capsule chamber region of the powder release device shown

[0082] Figure 9 shown is Figure 8 A cross-sectional top view of the capsule chamber region shown

[0083] Figure 10 shown is a partial enlarged view of the impeller at the bottom of the capsule chamber of the present invention

[0084] Figure 11 shown is Figure 1 Another cross-sectional view of a capsule chamber region of the powder release device shown

[0085] Figure 12 shown is Figure 11 A cross-sectional top view of the capsule chamber region shown

[0086] Figure 13 shown is an exploded view of the construction of a dry powder inhalation device of the present invention

[0087] Figure 14 shown is Figure 13 A partial cross-sectional view of the dry powder inhalation device shown

[0088] Figure 15 shown is Figure 13 A perspective view of the mouthpiece of the dry powder inhalation device shown

[0089] Figure 16 shown is Figure 13 A perspective view of the screen cover of the dry powder inhalation device shown

[0090] Figure 17 shown is Figure 13 A cross-sectional top view of the multiple capsule chamber of the dry powder inhalation device shown

[0091] Figure 18 shown is a cross-sectional top view of the multiple capsule chamber of another dry powder inhalation device of the present invention

[0092] Figure 19 shown is a cross-sectional top view of the multiple capsule chamber of another dry powder inhalation device of the present invention DETAILED DESCRIPTION

[0093] The present invention will be further described in connection with the specific embodiments. It should be understood, however, that the above-described subject matter, rather than the specific embodiments, is intended to be illustrative of the present invention. Any technical solution achieved based on the content of the present invention is within the scope of the present invention.

[0094] Referring to Figure 1 , Figure 2 and Figure 3 whereinFigure 1 As a specific embodiment of the powder releasing device of the present application, it comprises: (a) a capsule chamber 1, which is a cylindrical chamber for accommodating a capsule, the capsule chamber 1 is provided with an air outlet passage 11 at its top, and a breathable screen 12 is installed at the joint of the air outlet passage 11 and the capsule chamber 1. (b) an actuating part 2, which comprises at least one piercing needle 21 and is installed to be movable to the capsule chamber 1 to pierce the capsule, at least a part of the actuating part 2 is located outside the device to be manipulated by the user. (c) a mouthpiece 3, which is connected to the top of the capsule chamber 1 through the air outlet passage 11. Referring to Figure 2 , the capsule chamber 1 is provided with a deflected air inlet passage group which is in communication with the outside air, referring to Figure 3 , the deflected air inlet passage group comprises at least two deflected air inlet passages 13 which are arranged around the central axis of the capsule chamber and are synchronously deflected in the clockwise or counterclockwise direction, to provide a spiral airflow from the deflected air inlet passage group to the top air outlet passage 11 when the user inhales.

[0095] In this embodiment, the user first opens the screen 12 installed above the capsule chamber 1, and then puts in the capsule, and then presses the actuating part 2 to pierce the capsule, and then the actuating part 2 is reset by hand or elastic component, because the mouthpiece 3 is in communication with the capsule chamber 1 through an air outlet passage 11, and the capsule chamber 1 is in communication with the outside environment through the deflected air inlet passage group, when the user inhales, the outside environment air generates a spiral airflow around the capsule chamber 1 through the deflected air inlet passage group, which promotes the rapid rotation of the pierced capsule to release the inhalable powder contained therein, and the inhalable powder moves to the air outlet passage 11 at the top of the capsule chamber 1 along with the airflow, and enters the user's body through the mouthpiece 3.

[0096] It should be noted that the deflected air inlet passages 13 in this embodiment are deflected in the clockwise or counterclockwise direction, which does not mean that the deflected air inlet passage group must be opened in the horizontal direction, as long as it can provide a part of the airflow deflected in the horizontal direction, of course, the at least two deflected air inlet passages 13 should be synchronously deflected, for example, when the deflected air inlet passages 13 are located on the side wall, they should all be deflected upward, all be deflected downward, or all be deflected in the horizontal direction.

[0097] Compared with the prior art, the powder releasing device of the present application greatly reduces the requirement for the user's inhalation flow during the capsule rotation in the prior art, makes the powder release easier, and reduces the residual amount.

[0098] Further preferably, referring to Figure 1 , in an embodiment, the lower side of the breathable screen 12 is convex to the capsule chamber 1, which can provide a low-resistance capsule rotation contact surface.

[0099] Further preferably, referring toFigure 2 and Figure 3 In one embodiment, the deflected air inlet channel group is arranged on the lower part of the side wall of the capsule chamber 1, and the capsule chamber 1 is further provided with an air inlet channel 14 at the bottom thereof, which is opened upward along the central axis of the capsule chamber 1 to provide a through air flow from bottom to top through the capsule chamber 1.

[0100] In the present embodiment, the air inlet channel 14 at the bottom of the capsule chamber 1 can provide a through air flow from bottom to top through the entire capsule chamber 1 to help the capsule top end rotate against the top air-permeable screen 12 of the capsule chamber 1 and make the powder released by the capsule move more smoothly toward the top air outlet channel 11.

[0101] Further preferably, referring to Figure 4 and Figure 5 In one embodiment, the deflected air inlet channel group is arranged on the lower part of the side wall of the capsule chamber 1, and the capsule chamber 1 is further provided with an air inlet channel 14 at the bottom thereof, which is opened upward along the central axis of the capsule chamber 1 to provide a through air flow from bottom to top through the capsule chamber 1.

[0102] Arranging the deflected air inlet channel group on the lower part of the side wall of the capsule chamber 1 can better provide a through air flow from bottom to top through the entire capsule chamber 1 to help the capsule top end rotate against the top air-permeable screen 12 of the capsule chamber 1 and make the powder released by the capsule move more smoothly toward the top air outlet channel 11.

[0103] Further preferably, referring to Figure 6 and Figure 7 In one embodiment, the deflected air inlet channel group is arranged on the lower part of the side wall of the capsule chamber 1, and the capsule chamber 1 is further provided with an air inlet channel 14 at the bottom thereof, which is opened upward along the central axis of the capsule chamber 1 to provide a through air flow from bottom to top through the capsule chamber 1.

[0104] Arranging the deflected air inlet channel group on the lower part of the side wall of the capsule chamber 1 can better provide a through air flow from bottom to top through the entire capsule chamber 1 to help the capsule top end rotate against the top air-permeable screen 12 of the capsule chamber 1 and make the powder released by the capsule move more smoothly toward the top air outlet channel 11.

[0105] Referring to Figure 8 , Figure 9 and Figure 10 In another embodiment of the drug powder releasing device of the present application, the capsule chamber 1 is provided with a deflected air inlet channel group at the bottom thereof.

[0106] In the embodiment, the deflection air inlet passage groups at the bottom of the capsule chamber 1 can also be arranged uniformly around the central axis of the capsule chamber 1 and synchronously deflect in the clockwise or counterclockwise direction, which can provide a part of the deflected spiral airflow in the horizontal direction to help the capsule rotate and release the medicine, and also provide another part of the upward penetrating airflow to help the top end of the capsule rotate against the sieve screen 12 at the top of the capsule chamber 1 for ventilation, and make the powder released by the capsule more smoothly move towards the top air outlet passage 11, which is simple in structure and achieves two purposes at once.

[0107] Further preferably, referring to Figure 9 and Figure 10 , in an embodiment, the deflection air inlet passage groups at the bottom are arranged as a fixed impeller structure.

[0108] In the embodiment, the deflection air inlet passage groups of the impeller structure at the bottom of the capsule chamber 1 can be understood as four deflection air inlet passages 13 separated by four blades.

[0109] Further preferably, referring to Figure 11 and Figure 12 , in an embodiment, the deflection air inlet passage groups are provided at the bottom and the side wall of the capsule chamber 1.

[0110] In the embodiment, the deflection air inlet passage groups at the bottom of the capsule chamber 1 and the deflection air inlet passage groups at the side wall both play the role of providing deflected airflow, and the deflection air inlet passage groups at the bottom can also provide upward penetrating airflow, which can also achieve the purpose of the application.

[0111] Referring to Figure 13 , Figure 14 , an embodiment of a dry powder inhalation device of the application comprises: (a) a capsule chamber 1, which is a cylindrical container that can vertically contain a capsule, the top of the capsule chamber 1 is open, and the bottom is provided with an air inlet passage 14 in communication with the outside air; (b) an actuating part 2, which comprises a piercing needle 21 and is installed to be moved by a user to the side wall of the capsule chamber 1 to pierce the capsule; (c) a mouthpiece 3, referring to Figure 13 , 15 , which comprises an air outlet passage 11 below (in order to show clearly, Figure 13 the lower part of the air outlet passage 11 in the middle is cut off and separated to be shown separately); wherein the number of the capsule chambers 1 is two, the two capsule chambers 1 are arranged in parallel as an integrally formed double capsule chamber, and the actuating part 2 is separately provided between the two capsule chambers 1, each actuating part 2 is provided with two piercing needles 21 in the height direction, a sieve screen cover 15 is fixed at the bottom opening of the air outlet passage 11, referring to Figure 16 , a sieve screen 12 is fixed in the sieve screen cover 15 and is separately connected to the top of the double capsule chamber, so that the sieve screen 12 covers the top of the two capsule chambers 1.

[0112] In this embodiment, the double capsule chamber is composed of the first capsule chamber 1a and the second capsule chamber 1b which are closely arranged, and the first actuating part 2a and the second actuating part 2b are arranged at the two ends of the line on which the first capsule chamber 1a and the second capsule chamber 1b are located, and the first actuating part 2a and the second actuating part 2b can move from both sides to the middle to respectively pierce the capsules in the first capsule chamber 1a and the second capsule chamber 1b.

[0113] Firstly, the user separates the screen cover 15 from the top of the double capsule chamber to open the top of the double capsule chamber, fills the respective capsule chambers 1 with capsules containing two different active ingredients, and then closes the screen cover 15 to make the screen 12 cover the top of the capsule chambers 1 again; then, the user operates the actuating part 2 to move from both sides to the middle to respectively pierce the capsules in the first capsule chamber 1a and the second capsule chamber 1b, and the actuating part 2 is reset by the elastic part commonly used in the prior art; finally, the user tightly fits the mouth part to the mouthpiece 3 and forcibly inhales, and the external air enters the capsule chamber through the air inlet channel 14 at the bottom of the capsule chamber, so that the capsules are shaken and rotated at the screen 12 to release the powder, the released powder in the capsules enters the air outlet channel 11 through the screen 12, and finally enters the human body.

[0114] Although the actuating part 2 of this embodiment moves from both sides to the middle to respectively pierce the capsules in the first capsule chamber 1a and the second capsule chamber 1b, those skilled in the art can adjust the arrangement mode of the actuating part, for example, the actuating part 2 is arranged on one side of the line on which the first capsule chamber 1a and the second capsule chamber 1b are located, and the actuating part 2 includes at least two piercing needles in the width direction to simultaneously pierce the capsules in the first capsule chamber 1a and the second capsule chamber 1b by one actuating part 2 when operated.

[0115] Further preferably, referring to Figure 17 In one embodiment, each capsule chamber 1 side wall is respectively provided with a deflection air inlet channel group, and the deflection air inlet channel group includes two deflection air inlet channels 13 which are arranged around the axis of the capsule chamber 1 and are synchronously deflected in the clockwise or counterclockwise direction, to provide a spiral airflow moving upward from the deflection air inlet channel 13 when the user inhales.

[0116] Compared with the foregoing embodiments, the powder releasing device of this embodiment provides a spiral airflow moving upward from the deflection air inlet channel 13 when the user inhales by arranging the deflection air inlet channel group on the side wall of the capsule chamber 1, which can more smoothly help the capsule rotate, greatly reducing the requirement for the user's inhalation flow in the prior art when the capsule rotates to release the medicine, and making the powder releasing easier.

[0117] Further preferably, referring to Figure 13 , Figure 14 In one embodiment, the deflection air inlet channel group is arranged at the lower part of each capsule chamber 1 side wall.

[0118] Compared with the foregoing embodiments, the medicine powder releasing device of the present embodiment can not only provide the spiral air flow moving upward from the deflected air inlet channel 13, but also assist the bottom air inlet channel 14 to make the capsules abut against the top screen 12 of the capsule chamber.

[0119] Further preferably, referring to Figure 17 In one embodiment, the opening direction of the deflected air inlet channel 13 is tangent to the sidewall of each capsule chamber 1, so that the spiral air flow can more smoothly drive the capsules to rotate

[0120] Further preferably, referring to Figure 13 In one embodiment, the dry powder inhalation device further comprises:

[0121] (d) the lower housing 4, which defines a top-opened cavity for accommodating the double capsule chambers, the lower housing 4 is provided with two notches 41 on the side, so that at least a part of the actuating part 2 is located outside the device for the user to operate, the size of the notches 41 is extended and widened downward relative to the actuating part 2, so as to provide air inlet holes 42, so that the internal cavity can be in communication with the external air through the air inlet holes 42; (e) the adapter plate 5, which covers the top of the lower housing 4 and is provided with a hollow adapter port 51 at the top position of the double capsule chambers, referring to Figure 13 and Figure 14 the screen cover 15 is detachably mounted to the adapter port 51, so that the screen 12 covers the top of each capsule chamber 1. Referring to Figure 13 and 15 (f) the upper housing 6, which extends downward from the top of the mouthpiece 3 and defines a bottom-opened cavity surrounding the air outlet channel 11, and covers the adapter plate 5 when the screen cover 15 is mounted to the adapter port.

[0122] Firstly, the user separates the lower housing 4 and the upper housing 6, so that the screen cover 15 is separated from the top of the double capsule chambers, then the user fills each capsule chamber 1 with capsules containing two different active ingredients respectively, and finally closes the upper housing 6 and the lower housing 4, so that the screen 12 covers the top of each capsule chamber 1 again. Then, the user operates the part of the actuating part 2 located outside the housing to pierce the capsules in each capsule chamber 1, and the actuating part 2 is reset by the elastic member commonly used in the prior art. Finally, the user tightly fits the mouth to the mouthpiece 3 and inhales forcibly, so that the external air enters the internal cavity through the air inlet holes 42 of the lower housing 4, and enters the capsule chamber 1 from the air inlet channel 14 at the bottom of the capsule chamber 1, so that the capsules abut against the screen 12 and vibrate and rotate to release the powder, the released powder in the capsules enters the air outlet channel 11 through the small holes of the screen 12, and finally enters the human body.

[0123] Compared with the foregoing embodiments, the dry powder inhalation device of the present embodiment adds the upper shell 6, the lower shell 4 and the connecting plate 5, and increases the structural firmness of the device, thereby facilitating operation.

[0124] Further preferably, referring to Figure 13 、 Figure 14 and 15 , in an embodiment, a slit 52 is arranged at the joint of the upper shell 6 and the connecting plate 5, so that the internal cavity of the upper shell 6 is in communication with the external air through the slit 52. The sidewall of the air outlet channel 11 is provided with a small hole 111, which is arranged in a direction not facing the central axis of the air outlet channel 11, so as to promote the rotation of the airflow in the air outlet channel 11 when the user inhales.

[0125] When the user inhales, the external air can enter the internal cavity of the upper shell 6 through the slit, and then enter the air outlet channel 11 from the small hole 111 of the air outlet channel 11, so as to promote the rotation of the airflow in the air outlet channel 11. After the capsule medicine powder in each capsule chamber 1 of the present embodiment is released, the capsule medicine powder is transmitted in the air outlet channel 11 and mixed sufficiently by rotation, so that the movement speed of the capsule medicine powder reaching the suction port 3 is appropriate and the composition is uniform.

[0126] Further preferably, referring to Figure 14 , in an embodiment, the air outlet channel 11 gradually decreases in diameter from bottom to top, and forms a narrow neck portion 112 before reaching the outlet, so as to further make the movement speed of the capsule medicine powder reaching the suction port 3 appropriate and the composition uniform.

[0127] Referring to Figure 18 , the present embodiment is another embodiment of the dry powder inhalation device, wherein the multiple capsule chambers are arranged in a triangle shape by the first capsule chamber 1a, the second capsule chamber 1b and the third capsule chamber 1c. The first actuating portion 2a is arranged on one side of the line connecting the first capsule chamber 1a and the second capsule chamber 1b, and is provided with two piercing needles 21 arranged in the width direction, and can move towards the multiple capsule chambers to simultaneously pierce the capsules in the first capsule chamber 1a and the second capsule chamber 1b. The second actuating portion 2c is arranged on the side of the third capsule chamber 1c away from the first capsule chamber 1a and the second capsule chamber 1b, and is arranged to move in a direction perpendicular to the line connecting the first capsule chamber 1a and the second capsule chamber 1b to pierce the capsule in the third capsule chamber 1c.

[0128] The present embodiment provides a medicine dispenser containing three active components (or mixtures thereof) of a combination product in a separated manner by arranging three capsule chambers. The bottom of each capsule chamber 1 is provided with an air inlet channel 14, and the side or bottom is not provided with a deflection air inlet channel group. The arrangement of other components is the same as or similar to that of other embodiments, and will not be described here.

[0129] Further preferably, referring to Figure 18 In one embodiment, the hole diameter of the air inlet channel 14 at the bottom of one capsule chamber 1 is different from that of the other two capsule chambers 1, so that the air flow rate at the inlet of the capsule chamber 1 is different from that of the other two capsule chambers 1.

[0130] In some cases, the components of a combination product need to reach a specific aerosol particle distribution to maximize their effects. Since each component of the present application is released separately in the corresponding capsule chamber 1, by adjusting the size, position, opening angle and / or number of the deflected air inlet channel 13, air inlet channel 14 and / or air outlet channel 11, different aerodynamic parameters can be set for each capsule chamber 1 to maximize the therapeutic effect of each active ingredient under the premise of simultaneous administration. This embodiment adjusts the size of the air inlet channel 14 at the bottom of the capsule chamber 1 to give it different air flow rates, which affects the aerosol particle distribution of the drug powder in the capsule.

[0131] Referring to Figure 19 For another embodiment of the dry powder inhalation device of the present application, the multiple capsule chambers 1 are arranged in a square by the first capsule chamber 1a, the second capsule chamber 1b, the third capsule chamber 1c and the fourth capsule chamber 1d, the first actuating part 2a and the second actuating part 2b are arranged on the central axis of the square and can move from both sides to the middle, the first actuating part 2a and the second actuating part 2b include at least two piercing needles 21 in the width direction, so that the first actuating part 2a simultaneously pierces the capsules in the first capsule chamber 1a and the second capsule chamber 1b, and the second actuating part 2b simultaneously pierces the capsules in the third capsule chamber 1c and the fourth capsule chamber 1d.

[0132] This embodiment provides a pharmaceutical dispenser containing four active components (or mixtures thereof) of a combination product in a separate manner by providing four capsule chambers. The provision of four capsule chambers results in a higher requirement for patient inhalation flow for the inhalation device. In order to fully rotate the capsules for drug release, the bottom of each capsule chamber 1 of this embodiment is provided with a deflected air inlet channel group, which is arranged as a fixed impeller structure as a whole to provide a spiral airflow from bottom to top when the user inhales, effectively promoting the rotation of the capsules for drug release, wherein the specific shape of the impeller structure can refer to Figure 10 .

[0133] The above description is only a specific embodiment of the present application and is not intended to limit the scope of the present application. Any equivalent changes, modifications and combinations made by those skilled in the art without departing from the concept and principles of the present application shall fall within the scope of the present application.

Claims

1. A dry powder inhaler device comprising: a capsule chamber (1) which is a cylindrical cavity capable of upright containing a capsule, the top of the capsule chamber (1) being open; an actuating part (2) comprising a piercing needle (21) mounted to be moved by a user to the side wall of the capsule chamber (1) to pierce the capsule; a mouthpiece (3) comprising a gas outlet channel (11) below; wherein the number of the capsule chambers (1) is two to four, all the capsule chambers (1) are arranged in parallel as an integrated multi-capsule chamber, the capsule chambers (1) are provided with the actuating part (2) individually or in common, the actuating part (2) is provided with at least as many piercing needles (21) as the number of the capsule chambers (1) matched in the width direction, a mesh cover (15) is fixed at the bottom of the gas outlet channel (11) below the mouthpiece (3), the mesh cover (15) is inlaid with a mesh (12) and is detachably connected to the top of the multi-capsule chamber so that the mesh (12) covers the top of all the capsule chambers (1); wherein the bottom of each capsule chamber (1) is provided with an air inlet channel (14), and the side wall of each capsule chamber (1) is provided with a deflection air inlet channel group; wherein the side wall of the gas outlet channel (11) is provided with at least one small hole (111) communicating with the outside air, the small hole (111) is opened in a direction not towards the central axis of the gas outlet channel (11) to promote the rotation of the airflow in the gas outlet channel (11) when the user inhales, the caliber of the gas outlet channel (11) gradually decreases from bottom to top to form a narrow neck (112) before reaching the mouthpiece (3), and the small hole (111) of the gas outlet channel (11) is arranged on the lower side of the narrow neck (112).

2. A dry powder inhalation device according to claim 1, wherein, The deflection air inlet channel group comprises at least two deflection air inlet channels (13) arranged around the central axis of the capsule chamber (1) and deflected synchronously in the clockwise or counterclockwise direction.

3. The dry powder inhalation device of claim 1, wherein, The lower part of the side wall of each capsule chamber (1) is provided with a deflection air inlet channel group.

4. A dry powder inhalation device according to claim 2, wherein, The deflection air inlet channel group comprises two deflection air inlet channels (13) tangent to the side wall of the capsule chamber (1).

5. The dry powder inhalation device of claim 1, wherein, The size of the air inlet channel (14) and / or the top opening of at least one capsule chamber (1) is different from that of the other capsule chambers (1).

6. The dry powder inhalation device of claim 1, wherein, The number of the small holes (111) of the gas outlet channel (11) is two, which are symmetrically arranged around the central axis of the gas outlet channel (11).

7. The dry powder inhalation device of claim 1, wherein, The multi-capsule chamber is composed of closely arranged first capsule chambers (1a) and second capsule chambers (1b), and the first actuating part (2a) and the second actuating part (2b) are arranged at both ends of the line where the first capsule chambers (1a) and the second capsule chambers (1b) are located, and the first actuating part (2a) and the second actuating part (2b) can move from both sides to the middle to pierce the capsules in the first capsule chambers (1a) and the second capsule chambers (1b), respectively.

8. The dry powder inhalation device of claim 1, wherein, The multi-capsule chamber is composed of closely arranged first capsule chambers (1a) and second capsule chambers (1b), and the actuating part (2) is arranged on one side of the line where the first capsule chambers (1a) and the second capsule chambers (1b) are located, and the actuating part (2) comprises at least two piercing needles (21) in the width direction to pierce the capsules in the first capsule chambers (1a) and the second capsule chambers (1b) at the same time.

9. The dry powder inhalation device of claim 1, wherein, The multiple capsule chamber is arranged in a triangle by the first capsule chamber (1a), the second capsule chamber (1b) and the third capsule chamber (1c), the first actuating part (2a) is arranged on one side of the line connecting the first capsule chamber (1a) and the second capsule chamber (1b), the first actuating part (2a) is arranged with at least two needles (21) in the width direction and can move to the multiple capsule chamber to simultaneously pierce the capsules in the first capsule chamber (1a) and the second capsule chamber (1b), the second actuating part (2b) is arranged on the side of the third capsule chamber (1c) away from the first capsule chamber (1a) and the second capsule chamber (1b), and the second actuating part (2b) is arranged to move in the direction perpendicular to the line connecting the first capsule chamber (1a) and the second capsule chamber (1b) to pierce the capsules in the third capsule chamber (1c).

10. The dry powder inhalation device of claim 1, wherein, The multiple capsule chamber is arranged in a square by the first capsule chamber (1a), the second capsule chamber (1b), the third capsule chamber (1c) and the fourth capsule chamber (1d), the first actuating part (2a) and the second actuating part (2b) are arranged on the central axis of the square and can move from both sides to the middle, the first actuating part (2a) and the second actuating part (2b) include at least two needles (21) in the width direction, so that the first actuating part (2a) can simultaneously pierce the capsules in the first capsule chamber (1a) and the second capsule chamber (1b), and the second actuating part (2b) can simultaneously pierce the capsules in the third capsule chamber (1c) and the fourth capsule chamber (1d).

11. The dry powder inhalation device of claim 1, wherein, Further comprising: The lower shell (4) defines a top-open cavity capable of fixing the multiple capsule chamber, the side of the lower shell (4) is provided with a notch (41) matching the number and position of the actuating part (2), so that at least a part of each actuating part (2) is located outside the device for the user to operate, and the side and / or bottom is provided with a ventilated air inlet hole (42) so that the internal cavity can communicate with the outside air through the air inlet hole (42); The adapter plate (5) covers the top of the lower shell (4) and is provided with a hollow adapter port (51) at the top of the multiple capsule chamber, and the screen cover (15) is detachably mounted to the adapter port (51) so that the screen (12) covers the top of each capsule chamber (1) through the adapter port (51); The upper shell (6) extends downward from the top of the suction nozzle (3) and defines a bottom-open cavity surrounding the air outlet channel (11), and covers the adapter plate (5) when the screen cover (15) is mounted to the adapter port (51), and the joint between the upper shell (6) and the adapter plate (5) is provided with a gap (52) so that the internal cavity of the upper shell (6) can communicate with the outside air through the gap (52).

12. A dry powder inhaler device according to any one of claims 1 to 11, wherein, The diameter of the capsule chamber (1) is 1.1 to 2.5 times the diameter of the capsule, and the height is 1.02 to 2.0 times the height of the capsule.

13. A dry powder inhaler device according to claim 12, wherein, The diameter of the capsule chamber (1) is 1.2 to 1.5 times the diameter of the capsule, and the height is 1.05 to 1.3 times the height of the capsule.

14. The dry powder inhalation device of claim 12, wherein, The diameter of the capsule chamber (1) is 1.35 times the diameter of the capsule, and the height is 1.15 times the height of the capsule.

15. The dry powder inhalation device of claim 1, wherein, The number of capsule chambers (1) is two, the air resistance value of the dry powder inhalation device is 0.01-0.08 KPa 0.5 min / liter.

16. A dry powder inhaler device according to claim 15, wherein, The air resistance value of the dry powder inhalation device is 0.02-0.05 KPa 0.5 min / liter.

17. The dry powder inhalation device of claim 15, wherein, The air resistance value of the dry powder inhalation device is 0.0325 KPa 0.5 min / liter.

18. The dry powder inhalation device of claim 1, wherein, The number of capsule chambers (1) is three, the air resistance value of the dry powder inhalation device is 0.015-0.073 KPa 0.5 min / liter.

19. A dry powder inhaler device according to claim 18, wherein, The air resistance value of the dry powder inhalation device is 0.02-0.04 KPa 0.5 min / liter.

20. The dry powder inhalation device of claim 18, wherein, The air resistance value of the dry powder inhalation device is 0.0305 KPa 0.5 min / liter.

21. The dry powder inhalation device of claim 1, wherein, The number of capsule chambers (1) is four, the air resistance value of the dry powder inhaler device is 0.01-0.06 KPa 0.5 min / liter.

22. A dry powder inhaler device according to claim 21, wherein, The air resistance value of the dry powder inhalation device is 0.015-0.035 KPa 0.5 min / liter.

23. The dry powder inhalation device of claim 21, wherein, The air resistance value of the dry powder inhalation device is 0.029 KPa 0.5 min / liter.

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