Patent Grant
10773034
The present invention relates to an inhaler device for delivering a dose of medicament in dry powder form from a container to a patient in need thereof.
Inhalers are commonly used to deliver drugs into the lung of a patient in need thereof. Different types of inhalers have been developed and are available on the market, amongst which dry powder inhalers (DPIs) are becoming attractive in the treatment of various respiratory problems such as asthma, bronchitis or chronic obstructive pulmonary disease (COPD) and for the delivery of non-asthma drugs delivered via inhalation.
In dry powder inhalers, the dose of medicament is present in dry powder form and usually pre-packed in containers such as a capsule. Blister-based dry powder inhalers are also known.
In capsule-based dry powder inhalers, a capsule is placed into a capsule chamber of the inhaler before inhalation and opened, e.g. by piercing the capsule at its ends. Subsequently, the patient inhales through a nosepiece or mouthpiece whereupon an inhalation airflow is generated within the inhaler. The medicament in dry powder form is released from the capsule, entrained into the inhalation airflow and inhaled by the patient.
For dose consistency, it is desirable that as much as possible of the dose of medicament is released from the capsule, inhaled by the patient and delivered to the site of action in the lung.
Medicaments in dry powder form contained in capsules usually consist of a blend of the active ingredient and a bulking agent, e.g. lactose. The powder blend is usually present in form of big agglomerates which are usually a mixture of big and small particles. However, big particles often show a poor release from the capsule and/or a poor lung uptake. Thus, in conventional dry powder inhalers it is desired to break and/or de-agglomerate larger particles into smaller, breathable particles prior or during inhalation in order to allow for an efficient release from the capsule as well as an efficient lung uptake. Particles with a size of not more than 5 μm are believed to be particularly advantageous for an efficient lung uptake.
One approach of breaking down/de-aggregate larger particles inside the capsule during inhalation is to set the capsule into motion thereupon causing impacts between the capsule and the capsule chamber, whereby stronger impacts are believed to lead to a better breakdown of the powder particles and consequently to a more efficient release from the capsule.
Different techniques and capsule chamber geometries have been developed and applied in order to set the capsule into motion during inhalation.
EP 2 739 334 A1 relates to a capsule-based dry powder inhaler wherein the capsule is subjected to a horizontal, propeller-like movement. The inhaler is equipped with means that allow the capsule to serve as an air flow control valve and at the same time, this effect causes repetitive impacts of the capsule against the walls of the chamber in order to improve the outflow of the powder and its breakdown.
EP 1 603 615 B1 relates to an inhaler comprising a capsule chamber having a form and a volume greater than the capsule such that the capsule rotates during inhalation in a propeller-like motion.
U.S. Pat. No. 4,069,819 A relates to a capsule based dry powder inhaler comprising a nebulization chamber for a capsule in which an air passageway is formed in such manner as to set the flowing air in vortical motion such as to cause the capsule, under the action of the flowing air, to make movements of rotation, precession and vibration about and along its longitudinal axis.
However, these approaches often lead to randomly occurring, hardly reproducible and relatively weak impacts between the capsule and the capsule chamber which may cause an unsatisfactory and irreproducible breakdown of the powder and thereby a poor emptying of the capsule.
It is an object of the present invention to provide an inhaler device that overcomes the above problems. In particular, it is an object of the present invention to provide an inhaler device that shows an improved emptying of the capsule during inhalation. It is further an object of the present invention to provide a method for delivering a dose of medicament in dry powder form from a capsule to a patient.
The above mentioned objects are achieved by an inhaler device comprising an inhaler housing comprising at least one air inlet duct. The inhaler device further comprises an elongated capsule chamber adapted for receiving a capsule which contains a dose of medicament in dry powder form. The capsule chamber has a longitudinal axis and is defined by a wall arrangement including a first and a second supporting wall portion opposing each other in a direction perpendicular to the longitudinal axis of the capsule chamber. The wall arrangement further includes first and second sidewall portions opposing each other in the direction of the longitudinal axis of the capsule chamber. The inhaler device further comprises a mouthpiece portion through which the medicament in dry powder form is dispensable and at least first and second airflow paths which extend between the at least one air inlet duct, the capsule chamber and the mouthpiece portion to enable an inhalation airflow formed upon inhalation to flow through the at least one air inlet duct via the capsule chamber and the mouthpiece portion such that the dose of medicament is entrained in air and dispensed through the mouthpiece portion. The first and second airflow paths are arranged such that during inhalation, a capsule having a longitudinal axis and first and second end sections delimiting the capsule on opposing ends located in the capsule chamber performs an oscillating movement in the capsule chamber parallel to the longitudinal axis of the capsule chamber between the first and the second sidewall portions when an airflow is initiated through the first and the second airflow paths in a direction from the at least one air inlet duct towards the mouthpiece portion.
The first airflow path comprises at least a first intermediate duct extending from the at least one air inlet duct to a first capsule chamber inlet adjacent to the first sidewall portion, and at least a first outlet duct extending from a first capsule chamber outlet adjacent to the first sidewall portion to the mouthpiece portion. The second airflow path preferably comprises at least a second intermediate duct extending from the at least one air inlet duct to a second capsule chamber inlet adjacent to the second side wall, and at least a second outlet duct extending from a second capsule chamber outlet adjacent to the second sidewall portion to the mouthpiece portion. The first capsule chamber inlet is formed between the first supporting wall portion and the first sidewall portion. The second capsule chamber inlet is formed between the first supporting wall portion and the second sidewall portion. The first capsule chamber outlet is formed between the second supporting wall portion and the first sidewall portion. The second capsule chamber outlet is formed between the second supporting wall portion and the second sidewall portion.
Preferably, the first supporting wall portion has an extension in a direction extending parallel to the longitudinal axis of the capsule chamber with a length “A” and the second supporting wall portion has an extension in a direction extending parallel to the longitudinal axis of the capsule chamber with a length “B”.
Preferably, while performing the oscillating movement, impacts between the capsule, in particular between its first and second end sections, and the first and second sidewall portions of the capsule chamber are generated such that a dose of medicament in dry powder form contained within the capsule is broken down into fine, breathable particles and finely dispersed inside the capsule, whereupon the fine particles are released into the airstream.
Preferably, the capsule containing a dose of medicament in dry powder form comprises a central section between said first and second end sections. Preferably, the central section is in cylindrical form. The central section of the capsule is preferably adapted to be supported by the first and second supporting wall portions against a movement in a plane extending perpendicular to the longitudinal axis. According to this embodiment, after being inserted into the capsule chamber, the capsule moves only parallel to its longitudinal axis between the first and second sidewall portions.
According to a preferred embodiment, the inhaler device further comprises a moveable piercing means for piercing a capsule located in the capsule chamber. The piercing means is preferably located in the first and second sidewall portions of the capsule chamber. According to this embodiment, the capsule is preferably pierced at its first and second end sections. Alternatively, the capsule may be opened by cutting means.
It is preferred that the distance between the first supporting wall portion and the first sidewall portion (in the following termed “size of the first capsule chamber inlet”) is identical to the distance between the first supporting wall portion and the second sidewall portion (in the following termed “size of the second capsule chamber inlet”). Or in other words: The first capsule chamber inlet and the second capsule chamber inlet are of the same size. It is further preferred that the distance between the second supporting wall portion and the first sidewall portion (in the following termed “size of the first capsule chamber outlet”) is identical to the distance between the second supporting wall portion and the second sidewall portion (in the following termed “size of the second capsule chamber outlet”). Or in other words: The first capsule chamber outlet and the second capsule chamber outlet are of the same size. It is further preferred that the capsule inserted into the capsule chamber has an extension between its first and second end sections that is larger than the larger one of said sizes of the first and second capsule chamber inlets and first and second capsule chamber outlets. In this way, the capsule acts as an airflow barrier preventing air to flow from the first airflow path to the second airflow path (or vice versa) within the capsule chamber.
Is it particularly preferred that the capsule inserted into the capsule chamber has an extension between its first and second end sections that is larger than the larger one of the sum of the length “A” and the size of the first or second capsule chamber inlet and the sum of the length “B” and the size of the first or second capsule chamber outlet. This means that if, for example, the sum of the length “A” and the size of the first or second capsule chamber inlet is larger than the sum of the length “B” and the size of the first or second capsule chamber outlet, the capsule has an extension between its first and second end sections that is larger than the sum of the length “A” and the size of the first or second capsule chamber inlet.
In this way, a constriction zone is created within the capsule chamber between the first or second sidewall portion of the capsule chamber and the first or second end section of the capsule. Thus, according to the principle of continuity, air flowing through the capsule chamber has an increased velocity when flowing through said constriction zone. According to the principle of conservation of mechanical energy, said gain in kinetic energy—due to the increased velocity of the air flowing through the constriction zone—leads to a drop in pressure in the capsule chamber at the proximity of the first or second sidewall. This effect is also known as the Venturi effect. Consequently, due to the reduced pressure in the capsule chamber at the proximity of the first or second sidewall portion, the capsule is moved towards the first or second sidewall portion during inhalation.
According to another embodiment, the first capsule chamber inlet and the second capsule chamber inlet are of different size and/or the first capsule chamber outlet and the second capsule chamber outlet are of different size. Also in this case it is preferred that the capsule inserted into the capsule chamber has an extension between its first and second end sections that is larger than the largest one of said sizes of the first and second capsule chamber inlets and first and second capsule chamber outlets. In this way, the capsule acts as an airflow barrier preventing air to flow from the first airflow path to the second airflow path (or vice versa) within the capsule chamber.
According to this embodiment, it is particularly preferred that the capsule inserted into the capsule chamber has an extension between its first and second end sections that is larger than the largest one of the sum of the length “A” and the size of the first or second capsule chamber inlet and the sum of the length “B” and the size of the first or second capsule chamber outlet. In this way, a constriction zone is created within the capsule chamber between the first or second sidewall and the first or second end section of the capsule.
According to a preferred embodiment of the inhaler device according to the present invention, the first and second intermediate ducts taper in direction from the at least one air inlet duct to the first and second capsule chamber inlets. Thereby, according to the principle of continuity, air flowing from the at least one air inlet duct to the capsule chamber is accelerated when flowing through first and second (tapering) intermediate ducts.
According to a further preferred embodiment of the inhaler according to the present invention, first and second outlet ducts are not curved. Alternatively, according to another preferred embodiment of the inhaler according to the present invention, first and/or second outlet ducts are curved (bent). It is preferred that both of the first and second outlet ducts are curved (bent). Preferably, first and second outlet ducts are connected to form one continuous curve, where the mouthpiece portion is connected to the apex of the curve formed by the first and second outlet ducts. In an embodiment where the inhaler comprises a classifier chamber (see below), the classifier chamber is connected to the apex of the curve formed by the first and second outlet ducts and the mouthpiece portion is connected to the apex of the curve formed by the first and second classifier ducts. According to another preferred embodiment of the inhaler according to the present invention, first and/or second outlet ducts are curved and connected to form a wavy form comprising two crests and one trough. Preferably, the mouthpiece portion is connected to the trough. This design of the first and second outlet ducts shall provide that air flowing through the curved first and/or second outlet ducts changes its direction when flowing through the curve. Thereby, larger and heavier particles hit the walls of the curved sections (inertia impaction) whereby they are broken down and/or de-agglomerated into smaller particles. Or in other words: The curved first and second outlet ducts act as a static classifier during inhalation.
It is further preferred that the first and second outlet ducts expand in direction from the first and second capsule chamber outlets to the mouthpiece portion. Preferably, the first and second outlet ducts continuously expand in direction from the first and second capsule chamber outlets to the mouthpiece portion. Thereby, according to the principle of continuity, air flowing from the capsule chamber to the mouthpiece portion is decelerated when flowing through (expanding) first and second outlet ducts.
It is further preferred that the one or more air inlet duct/s discontinuously expand/s prior to its/their connection with the at least first and second airflow paths. Thus, an inhalation airflow formed upon inhalation forms an air stream into a larger space upon exiting the air inlet duct. Due to the so-called Coanda effect, said air stream is randomly attracted to a nearby surface such that it either streams into the first or into the second airflow path. Whether the air stream flows into the first or second airflow path also depends on whether the capsule blocks one of said first or second airflow paths. If, for example, the capsule inserted into the capsule chamber blocks the second airflow path, airflow is only possible through the first airflow path and thus, said air stream will be attracted to a surface of the first airflow path. In this case, the air stream flows into the first airflow path and a reduced pressure is generated within the capsule chamber at the proximity of the first side wall due to the Venturi effect. Consequently, the capsule is moved towards the first side wall thereby inhibiting airflow through the first airflow path. Or in other words: The first airflow path is now blocked by the capsule. In this situation air can only flow through the second airflow path. If air now flows through the second airflow path and a reduced pressure is generated in the capsule chamber at the proximity of the second sidewall portion due to the Venturi effect and the capsule is now moved towards the second sidewall portion. In this situation airflow through the second airflow path is inhibited. Now, the second airflow path is (re-)closed by the capsule whereby the first airflow path is (re-)opened. Thus, the capsule itself acts as a fluidic trigger that switches the airflow from the first to the second airflow path and vice versa.
According to another preferred embodiment the inlet duct comprises a first inlet sidewall portion and a second inlet sidewall portion which taper towards an inlet opening such that a flow cross-section formed by the first and second inlet sidewall portions decreases towards the inlet opening and discontinuously expands in direction of the inhalation airflow herein after. This furthermore increases the tendency of the air to either stream into the first or into the second airflow path as described above. In detail it increases the tendency of the air to either flow along a first intermediate side wall portion which defines the first intermediate duct on its right side or alternatively flow along a second intermediate side wall portion defining the second intermediate duct on its left side. Because of the discontinuously change of the flow cross-section there are recirculating regions between the air flowing towards the capsule chamber and the intermediate side wall portions. By preferably choosing a width of a bottom wall which comprises the inlet opening in the range of 7 mm to 11 mm, preferably of 9 mm, in combination with a width of the inlet opening in the range of 0.5 mm to 5 mm, preferably of 2 mm of 2 mm there are additional small perturbations which result in a further drop in pressure of the recirculating regions and further drag the air towards an intermediate side wall portion. In other words: A ratio between a diameter of a bottom wall which comprises an inlet opening and a diameter of the inlet opening in the range of 2.2 to 14, preferably 3 to 10, more preferably of 4.5, will result in a further drop in pressure of the recirculating regions and further drag the air towards an intermediate side wall portion.
It has to be understood that the recirculating regions and the additional small perturbations will arise close to the first as well as close to the second intermediate sidewall portion when the air flows along the first airflow path or the second airflow path, respectively. Thus, as described above the air will have a tendency to flow along the first or the second airflow path until the capsule moves horizontally and blocks the corresponding first or second airflow path.
According to a preferred embodiment, the inhaler device further comprises a first inlet loop duct extending from a region within the first intermediate duct to the air inlet duct, and a second inlet loop duct extending from a region within the second intermediate duct to the air inlet duct. Said first and second inlet loop ducts have the function of guiding a part of the inhalation airflow flowing through the first or second intermediate duct to the air inlet duct such that said part of the inhalation airflow laterally impinges on the air stream formed by the inhalation airflow. If for example, the air stream formed by the inhalation airflow streams into the first airflow path, a part of said air stream flowing through the first intermediate duct is guided through the first inlet loop duct to the air inlet duct where it laterally impinges on the air stream thereby causing the air stream to switch into the second airflow path. Subsequently, a part of the air stream flowing through the second intermediate path is guided through the second inlet loop duct to the air inlet duct where it laterally impinges on the air stream thereby causing the air stream to switch back into the first airflow path. Thus, the inhalation airflow alternately flows into the first and second airflow path.
Preferably, the first and second loop ducts narrow prior to their connection with the air inlet duct.
According to a preferred embodiment, the inhaler device further comprises an outlet loop duct extending from the first capsule chamber outlet adjacent to the first sidewall portion and the first outlet duct to a second capsule chamber outlet adjacent to the second sidewall portion and the second outlet duct. The outlet loop duct has the function of guiding a part of the inhalation airflow formed upon inhalation flowing from the capsule chamber through one of the first and second outlet ducts in the direction of the mouthpiece to the other side of the capsule chamber such that said part of the inhalation airflow impinges the capsule in the proximity of its first or second end section such that the capsule is moved aside.
According to another preferred embodiment, the inhaler device further comprises a deflecting wall portion within the mouthpiece portion. The deflecting wall portion preferably extends in a direction parallel to first and second wall portions. During inhalation, larger particles hit the deflecting wall portion and are broken down/de-agglomerated into smaller particles.
According to a further preferred embodiment, the inhaler device comprises, in connection to first and second outlet ducts and the mouthpiece portion, a classifier chamber. The classifier chamber comprises a classifier chamber inlet duct and a classifier chamber outlet duct, wherein the classifier chamber inlet duct is preferably connected to first and second outlet ducts and the classifier chamber outlet duct is preferably connected to the mouthpiece portion. Preferably, when first and second outlet ducts are curved and connected to form one continuous curve, the classifier chamber inlet duct is connected to the apex of the continuous curve formed by the first and second outlet ducts. The classifier chamber further comprises a classifier chamber deflecting wall portion extending in a direction parallel to first and second wall portions and first and second classifier ducts extending between the classifier chamber inlet duct and the classifier chamber outlet duct. Preferably, first and second classifier ducts are curved and connected to form one continuous curve, where the mouthpiece portion is connected to the apex of the curve formed by the first and second classifier ducts. During inhalation, larger particles hit the deflecting wall portion and are broken down/de-agglomerated into smaller particles. Subsequently, larger and heavier particles still remaining in the inhalation airflow hit the walls of the curved section (inertia impaction) whereby they are broken down and/or de-agglomerated into smaller particles.
The above objects are further achieved by a method of delivering a dose of medicament in dry powder form from a capsule to a patient in need thereof. In a first step, a capsule having a longitudinal axis and first and second end sections which contains a dose of medicament in dry powder form is provided.
Furthermore, an inventive inhaler device is provided and the capsule is inserted into the capsule chamber of the inhaler device.
Subsequently, openings are pierced at the first and second end sections of the capsule using movable piercing means. Preferably, said moveable piercing means are located in the first and second sidewalls of the capsule chamber.
After piercing the openings into the first and second end sections of the capsule, the patient inhales through the mouthpiece portion such that an inhalation airflow is formed. The inhalation airflow flows through the one or more air inlet ducts via the capsule chamber and the mouthpiece portion into the patient's lungs. Upon inhalation, the capsule located in the capsule chamber performs an oscillating movement in the capsule chamber parallel to its longitudinal axis between the first and the second sidewall portions when an airflow is initiated through the first and the second airflow paths in a direction from the at least one air inlet duct towards the mouthpiece portion.
The capsule to be inserted into the inhaler according to the present invention is preferably made of gelatin, HPMC, aluminium and/or any other material which can hold the dry powder and which can be pierced or slit to open.
The invention is further described by referring to the appended figures which show preferred embodiments and shall by no means limit the present invention.
With reference to
The inhaler comprises an inhaler housing 10 comprising one air inlet duct 20 through which ambient air flows into the inhaler device during inhalation. The inhaler further comprises an elongated capsule chamber 30 adapted for receiving a capsule 40 containing a dose of medicament in dry powder form.
The capsule chamber 30 has a longitudinal axis and is defined by a wall arrangement including a first and a second supporting wall portion 50, 55 opposing each other in a direction perpendicular to the longitudinal axis. As shown in
The wall arrangement further includes first and second sidewall portions 60, 65 opposing each other in the direction of the longitudinal axis of the capsule chamber 30.
The inhaler device further comprises a mouthpiece portion 70 through which the medicament in dry powder form is dispensable.
Moreover, the embodiment of the inventive inhaler device shown in
The first airflow path 80 comprises a first intermediate duct 100 extending from the one air inlet duct 20 to a first capsule chamber inlet 110 adjacent to the first sidewall portion 60 and a first outlet duct 120 extending from a first capsule chamber outlet 130 adjacent to the first sidewall portion 60 to the mouthpiece portion 70. The second airflow path 85 comprises a second intermediate duct 105 extending from the air inlet duct 20 to a second capsule chamber inlet 115 adjacent to the second sidewall portion 65, and a second outlet duct 125 extending from a second capsule chamber outlet 135 adjacent to the second sidewall portion 65 to the mouthpiece portion 70.
Said first and second outlet ducts 120, 125 expand in direction from the first and second capsule chamber outlets 130, 135 to the mouthpiece portion 70.
The first capsule chamber inlet 110 is formed between the first supporting wall portion 50 and the first sidewall portion 60. The second capsule chamber inlet 115 is formed between the first supporting wall portion 50 and the second sidewall portion 65. The first capsule chamber outlet 130 is formed between the second supporting wall portion 55 and the first sidewall portion 60. The second capsule chamber outlet 135 is formed between the second supporting wall portion 55 and the second sidewall portion 65.
In the embodiment shown in
The capsule 40 inserted into the capsule chamber 30 has an extension between its first and second end sections 90, 95 that is larger than the size of the first and second capsule chamber inlets 110. In particular, the capsule 40 inserted into the capsule chamber 30 has an extension between its first and second end sections that is larger than the sum of length “B” and the size of the first or second capsule chamber outlet 130, 135. In this way, the capsule 40 acts as an airflow barrier preventing air to flow from the first airflow path 80 to the second airflow path 85 (or vice versa) within the capsule chamber 30. Additionally, a constriction zone is created within the capsule chamber 30 between the first or second sidewall portion 60, 65 and the first or second end section 90, 95 of the capsule 40.
Furthermore, the embodiment shown in
During inhalation, an inhalation airflow is formed within the inhaler device. The inhalation airflow forms an air stream into a larger space upon exiting the air inlet duct 20. As the second airflow path 85 is blocked by the capsule 40, said air stream flows into the first airflow path 80. According to the principle of continuity, the inhalation airflow has an increased velocity when flowing through the constriction zone formed between the first end section 90 of the capsule 40 and the first sidewall portion 60. According to the principle of conservation of mechanical energy, said gain in kinetic energy—due to the increased velocity of the air flowing through the constriction zone—leads to a drop in pressure in the capsule chamber 30 at the proximity of the first sidewall portion 60 (Venturi effect). Consequently, due to the reduced pressure in the capsule chamber 30 at the proximity of the first sidewall portion 60, the capsule 40 is moved towards the first sidewall portion 60. Subsequently, after being moved to the first sidewall portion 60, the capsule 40 blocks the first airflow path 80. At the same time, the second airflow path 85 is opened. The capsule 40 now forms a constriction zone within the capsule chamber 30 between the second end section 95 of the capsule 40 and the second sidewall portion 65. Now, as the first airflow path 80 is blocked by the capsule 40, the inhalation airflow stream into the second airflow path 85 thereby creating a reduced pressure inside the capsule chamber 30 when flowing through the constriction zone. Thus, the capsule 40 is moved to the second sidewall portion 65 thereby (re-)opening the first airflow path 80 and (re-)closing the second airflow path 85. In this way, the capsule 40 performs an oscillating movement in the capsule chamber 30 parallel to its longitudinal axis between the first and second sidewall portions 60, 65 when an airflow is initiated through the first and the second airflow paths 80, 85 in a direction from the air inlet duct 20 towards the mouthpiece portion 70. While performing the oscillating movement, impacts between the capsule 40, in particular its first and second end sections 90, 95, and the first and second sidewall portions 60, 65 of the capsule chamber 30 are generated such that a dose of medicament in dry powder form contained within the capsule 40 is broken down into fine, breathable fractions and finely dispersed inside the capsule 40. The finely dispersed powder exits the capsule 40 through holes in the first and second end sections 90, 95, is entrained in the inhalation airflow dispensed through the mouthpiece portion 70.
With reference to
This embodiment of the inventive inhaler device corresponds to the embodiment shown in
With reference to
The inhaler comprises an inhaler housing 10 comprising one air inlet duct 20 through which ambient air flows into the inhaler device during inhalation. The inhaler further comprises an elongated capsule chamber 30 adapted for receiving a capsule containing a dose of medicament in dry powder form. The capsule 40 has a longitudinal axis and first and second end sections 90, 95 delimiting the capsule 40 on opposing ends. The capsule 40 further comprises a central, cylindrical section between said first and second end sections 90, 95.
The capsule chamber 30 has a longitudinal axis and is defined by a wall arrangement including a first and a second supporting wall portions 50, 55 opposing each other in a direction perpendicular to the longitudinal axis of the capsule chamber. The first supporting wall portion 50 has an extension in a direction extending parallel to the longitudinal axis of the capsule chamber 30 with a length “A” and the second supporting wall portion 55 has an extension in a direction extending parallel to the longitudinal axis of the capsule chamber 30 with a length “B”. In the embodiment shown in
The wall arrangement further includes first and second sidewall portions 60, 65 opposing each other in the direction of the longitudinal axis of the capsule chamber.
The inhaler device further comprises a mouthpiece portion 70 through which the medicament in dry powder form is dispensable.
Moreover, the embodiment of the inventive inhaler device shown in
The first airflow path 80 comprises a first intermediate duct 100 extending from the at least one air inlet duct 20 to a first capsule chamber inlet 110 adjacent to the first sidewall portion 60 and a first outlet duct 120 extending from a first capsule chamber outlet 130 adjacent to the first sidewall portion 60 to the mouthpiece portion 70. The second airflow path 85 comprises a second intermediate duct 105 extending from the at least one air inlet duct 20 to a second capsule chamber inlet 115 adjacent to the second side wall 65, and a second outlet duct 125 extending from a second capsule chamber outlet 135 adjacent to the second sidewall 65 to the mouthpiece portion 70.
The first capsule chamber inlet 110 is formed between the first supporting wall portion 50 and the first sidewall portion 60. The second capsule chamber inlet 115 is formed between the first supporting wall portion 50 and the second sidewall portion 65. The first capsule chamber outlet 130 is formed between the second supporting wall portion 55 and the first sidewall portion 60. The second capsule chamber outlet 135 is formed between the second supporting wall portion 55 and the second sidewall portion 65.
The size of the first capsule chamber inlet 110 is identical to the size of the second capsule chamber inlet 115 and the size of the first capsule chamber outlet 130 is identical to the size of the second capsule chamber outlet 135. The size of said first and second capsule chamber inlets 110, 115 is larger than the size of said first and second capsule chamber outlets 130, 135.
The capsule 40 inserted into the capsule chamber 30 has an extension between its first and second end sections 90, 95 that is larger than the size of the first and second capsule chamber inlets 110, 115. In particular, the capsule 40 inserted into the capsule chamber 30 has an extension between its first and second end sections 90, 95 that is larger than the sum of the length “B” and the size of the first or second capsule chamber outlet 130, 135. In this way, the capsule 40 acts as an airflow barrier preventing air to flow from the first airflow path 80 to the second airflow path 85 (or vice versa) within the capsule chamber 30. Furthermore, a constriction zone is created within the capsule chamber 30 between the first or second sidewall portion 60, 65 and the first or second end section 90, 95 of the capsule 40.
Furthermore, the air inlet duct 20 abruptly expands prior to its connection with the at least first and second airflow paths 80, 85 such that an inhalation airflow formed upon inhalation forms air stream into a larger space upon exiting the air inlet duct 20.
Moreover, the embodiment shown in
During inhalation, an inhalation airflow is formed within the inhaler device. The inhalation airflow forms an air stream into a larger space upon exiting the air inlet duct 20. As the second airflow path 85 is blocked by the capsule (see
With reference to
The inhaler comprises an inhaler housing 10 comprising one air inlet duct 20 through which ambient air flows into the inhaler device during inhalation. The inhaler further comprises an elongated capsule chamber 30 adapted for receiving a capsule containing a dose of medicament in dry powder form. The capsule 40 has a longitudinal axis and first and second end sections 90, 95 delimiting the capsule 40 on opposing ends. The capsule 40 further comprises a central, cylindrical section between said first and second end sections 90, 95.
The capsule chamber 30 has a longitudinal axis and is defined by a wall arrangement including a first and a second supporting wall portion 50, 55 opposing each other in a direction perpendicular to the longitudinal axis of the capsule chamber 30. The first supporting wall portion 50 has an extension in a direction extending parallel to the longitudinal axis of the capsule chamber 30 with a length “A” and the second supporting wall portion 55 has an extension in a direction extending parallel to the longitudinal axis of the capsule chamber 30 with a length “B”. In the embodiment shown in
The wall arrangement further includes first and second sidewall portions 60, 65 opposing each other in the direction of the longitudinal axis of the capsule chamber.
The inhaler device further comprises a mouthpiece portion 70 through which the medicament in dry powder form is dispensable.
Moreover, the embodiment of the inventive inhaler device shown in
The first airflow path 80 comprises a first intermediate duct 100 extending from the air inlet duct 20 to a first capsule chamber inlet 110 adjacent to the first side wall 60 and a first outlet duct 120 extending from a first capsule chamber outlet 130 adjacent to the first sidewall 60 to the mouthpiece portion 70. The second airflow path 85 comprises a second intermediate duct 105 extending from the at least one air inlet duct 20 to a second capsule chamber inlet 115 adjacent to the second side wall 65, and a second outlet duct 125 extending from a second capsule chamber outlet 135 adjacent to the second sidewall 65 to the mouthpiece portion 70.
The first capsule chamber inlet 110 is formed between the first supporting wall portion 50 and the first sidewall portion 60. The second capsule chamber inlet 115 is formed between the first supporting wall portion 50 and the second sidewall portion 65. The first capsule chamber outlet 130 is formed between the second supporting wall portion 55 and the first sidewall portion 60. The second capsule chamber outlet 135 is formed between the second supporting wall portion 55 and the second sidewall portion 65.
The size of the first capsule chamber inlet 110 is identical to the size of the second capsule chamber inlet 115 and the size of the first capsule chamber outlet 130 is identical to the size of the second capsule chamber outlet 135. The size of said first and second capsule chamber inlets 110, 115 is smaller than the size of said first and second capsule chamber outlets 130, 135.
The capsule 40 inserted into the capsule chamber 30 has an extension between its first and second end sections 90, 95 that is larger than the size of the first and second capsule chamber outlets 130, 135. In particular, the capsule 40 inserted into the capsule chamber 30 has an extension between its first and second end sections 90, 95 that is larger than the sum of length “A” and the size of the first or second capsule chamber inlet 110, 115. In this way, the capsule 40 acts as an airflow barrier preventing air to flow from the first airflow path 80 to the second airflow path 85 (or vice versa) within the capsule chamber 30.
The inhaler device further comprises an outlet loop duct 150 extending from the first capsule chamber outlet 130 adjacent to the first sidewall portion 60 and the first outlet duct 120 to a second capsule chamber outlet 135 adjacent to the second sidewall portion 65 and the second outlet duct 125. The outlet loop duct 150 has the function of guiding a part of the inhalation airflow formed upon inhalation flowing from the capsule chamber 30 through one of the first and second outlet ducts 120, 125 in the direction of the mouthpiece portion 70 to the other side of the capsule chamber 30 such that said part of the inhalation airflow impinges the capsule 40 in the proximity of its first or second end section 90, 95 such that the capsule 40 is pushed aside.
During inhalation, an inhalation airflow is formed within the inhaler device.
With reference to
This embodiment basically corresponds to the embodiment shown in
Thus, during inhalation, air flowing through the curved first and second outlet ducts 120, 125 changes its direction when flowing through the curve and thereby, larger and heavier particles hit the (outer) wall of the curved sections (inertia impaction) whereby they are broken down and/or de-agglomerated into smaller particles. Or in other words: The curved first and second outlet ducts 120, 125 act as a static classifier during inhalation.
With reference to
This embodiment of the inventive inhaler device basically corresponds to the embodiment shown in
With reference to
The embodiment shown in
Thus, during inhalation, air flowing through the curved first and second outlet ducts 120, 125 changes its direction when flowing through the curve and thereby, larger and heavier particles hit the (outer) wall of the curved sections (inertia impaction) whereby they are broken down and/or de-agglomerated into smaller particles.
With reference to
With reference to
In both embodiments, the inlet duct 20 comprises a first inlet sidewall portion 200 and a second inlet sidewall portion 205 which taper towards an inlet opening 210. The inlet opening 210 is defined at the point where the first and second inlet sidewall portions 200, 205 cease to converge towards each other and either converge with a bottom wall 230 in the case of
A flow cross-section formed by the first and second inlet sidewall portions 200, 205 decreases towards the inlet opening 210, and in the case of
The abrupt change in cross-section and expansion encourages the inhaled air to form a jet as it enters the first intermediate duct. As a jet, the inhaled air will have a tendency to either flow along a first intermediate side wall portion 240 which defines the first intermediate duct 100 on its right side or alternatively to flow along a second intermediate side wall portion 245 defining the second intermediate duct 105 on its left side. The jet can then be encouraged to switch between the ducts 100 and 105 by the presence of natural jetflow instabili-ties, downs-stream blockage from the capsule, or a deliberate pressure pulse targeted laterally at the jet as provided by extra channels similar to those shown in
The first intermediate side wall portion 240 runs from the bottom wall 230 towards the first sidewall portion 60. Analogously the second intermediate side wall portion 245 runs from the bottom wall 230 towards the second sidewall portion 65.
A vertical distance C between the lowermost end of the first and second inlet sidewall portions 200, 205 and the bottom wall 230 comprising the inlet opening 210 is preferably in the range of 5 mm to 10 mm, more preferably about 7 mm. The inlet opening 210 preferably has a width D1 in the range of 0.5 mm to 5 mm, more preferably of about 2 mm. The bottom wall 230 preferably has a width D2 in the range of 7 mm to 11 mm, more preferably of about 9 mm. The first and second intermediate sidewall portions 240, 245 and the bottom wall 230 preferably enclose an angle W1 in the range of 100° to 120°, more preferably about 108°, such that the first and second intermediate sidewall portions 240, 245 diverge towards the capsule chamber 30.
The first supporting wall portion 50 forms a horizontal wall of a first capsule support having a triangular shape. The first capsule support 250 comprises two sidewalls 255 converging at a lower tip 260.
A vertical distance E between the bottom wall 230 and the lower tip 260 of the first capsule support 250 is preferably in the range of 5 mm to 10 mm, more preferably about 8.5 mm. A vertical height F of the first capsule support 250 between the lower tip 260 and the first supporting wall portion is preferably in the range of 2 mm to 7 mm, more preferably about 5 mm. Both sidewalls 255 preferably enclose an angle W2 at the lower tip 260 in the range of 70° to 90°, more preferably about 78°.
A vertical height G of the capsule chamber 30 between the first supporting wall portion 50 and the second supporting wall portion 55 is preferably in the range of 3 mm to 9 mm, more preferably about 6.4 mm. The horizontal width H of the capsule chamber 30 between the first and second sidewall portions 60, 65 is preferably in the range of 15 mm to 20 mm, more preferably 18.8 mm. The first and second outlet ducts 120, 125 preferably have a width I in the range of 1 mm to 6 mm, preferably about 3.7 mm.
It has to be understood that the inhaler device according to the present embodiment may comprise any of the first and second outlet ducts 120, 125 as described with reference to
| Number | Date | Country | Kind |
|---|---|---|---|
| 15191215 | Oct 2015 | EP | regional |
| Filing Document | Filing Date | Country | Kind |
|---|---|---|---|
| PCT/EP2016/075477 | 10/21/2016 | WO | 00 |
| Publishing Document | Publishing Date | Country | Kind |
|---|---|---|---|
| WO2017/068171 | 4/27/2017 | WO | A |
| Number | Name | Date | Kind |
|---|---|---|---|
| 4069819 | Valentini et al. | Jan 1978 | A |
| 5752505 | Ohki | May 1998 | A |
| 10456535 | Hemy | Oct 2019 | B2 |
| 20070240714 | Dunne et al. | Oct 2007 | A1 |
| 20120247465 | Wachtel et al. | Oct 2012 | A1 |
| 20130074841 | Schuckmann | Mar 2013 | A1 |
| 20150107589 | Longest | Apr 2015 | A1 |
| Number | Date | Country |
|---|---|---|
| 102014005646 | Jul 2015 | DE |
| 102014005647 | Jul 2015 | DE |
| 1488819 | Dec 2004 | EP |
| 1603615 | Dec 2005 | EP |
| 2739334 | Jun 2014 | EP |
| 2460281 | Nov 2009 | GB |
| 2013016787 | Feb 2013 | WO |
| 2013169473 | Nov 2013 | WO |
| 2015127258 | Aug 2015 | WO |
| Entry |
|---|
| International Search Report and Written Opinion dated Dec. 6, 2016 in corresponding PCT application No. PCT/EP2016/075477. |
| Behara et al., “Development of a High Efficiency Dry Powder Inhaler: Effects of Capsule Chamber Design and Inhaler Surface Modifications”, Pharmaceutical Research, vol. 31, pp. 360-372, 2014. |
| Number | Date | Country | |
|---|---|---|---|
| 20180264208 A1 | Sep 2018 | US |
