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Title:
AUTOMATIC DRY POWDER INHALER
Document Type and Number:
WIPO Patent Application WO/2023/038607
Kind Code:
A1
Abstract:
The present invention relates to the field of drug inhalers and more particularly to capsule-based dry powder inhalers and a device used to perforate the drug automatically. An inhaler(10) comprising a mouthpiece (11) comprising an airway, a cover (12) movable to close and open said mouthpiece (11) and comprising a cover hinge part (17), a carrier (16) having a capsule chamber (28) in which a dry powder capsule can be placed, a slot (14) in which said carrier (16) can be placed, and a body (13) comprising a body hinge part (18).

Inventors:
ALBUKREK YILMAZ (TR)
ISIK ENIS (TR)
DUDE UDAYA KUMAR (TR)
ERDOGAN UNNUGULSUM (TR)
Application Number:
PCT/TR2022/050973
Publication Date:
March 16, 2023
Filing Date:
September 12, 2022
Export Citation:
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Assignee:
ABDI IBRAHIM ILAC SANAYI VE TICARET ANONIM SIRKETI (TR)
International Classes:
A61M15/00; A61M11/00
Domestic Patent References:
WO2014204417A12014-12-24
WO2013095311A12013-06-27
Foreign References:
US20090165791A12009-07-02
US20200384218A12020-12-10
Attorney, Agent or Firm:
ALPIM PATENT (TR)
Download PDF:
Claims:
CLAIMS

1 . An inhaler (10) comprising

-a mouthpiece (11 ) comprising an airway,

- a cover (12) movable to close and open said mouthpiece (11 ) and comprising a cover hinge part (17),

-a carrier (16) having a capsule chamber (28) in which a dry powder capsule can be placed,

-a slot (14) in which said carrier (16) can be placed, and

-a body (13) comprising a body hinge part (18) wherein,

-a carrier (16) that can be placed in the slot (14) in said body (13) and can move around one edge in a circular manner,

-at least two actuators (23), which can be placed on said carrier (16) and can get closer to each other by moving in an axis perpendicular to the diameter of said circular motion,

-an actuator slide (29) in the form of a protrusion on the actuator (23) that provides said vertical movement,

-at least two side walls (22) that push the actuator slide (29) towards the capsule chamber (28) during said circular motion, and which can be inserted into said body (13) and each of which has sidewall slide (31 ) in the form of protrusions,

-at least two mutually extended needles (20) that move together with said actuator (23) and can reach said capsule chamber (28).

2. An inhaler (10) according to claim 1 , wherein said capsule chamber (28) has at least two needle paths (25) in the form of openings on its two opposite sides.

3. An inhaler (10) according to claim 1 , wherein the inhaler (10) comprises a spring (21 ) that is compressed on the actuator (23) that moves while passing over the sidewall slide (31 ) during the opening and closing of said carrier (16).

4. An inhaler (10) according to claim 1 , wherein said spring (21 ) pushes the actuator (23) towards the surface of the sidewalls (22).

5. An inhaler (10) according to claim 1 , wherein said sidewall slide (31 ) extends diagonally on the sidewall (22).

6. An inhaler (10) according to claim 1 , wherein said sidewall slide (31 ) has a form that tapers towards its periphery.

7. An inhaler (10) according to claim 1 , wherein said sidewall slide (31 ) has a circular form.

8. An inhaler (10) according to claim 1 , wherein said actuator slide (29) has a circular form.

9. An inhaler (10) according to claim 1 , wherein said body (13) comprises at least two actuator mounting (33) that prevent the actuator slide (29) from coming out of said slot (14) when said carrier (16) is open.

10. An inhaler (10) according to claim 1 , wherein said actuator (23) comprises an actuator protrusion (30) that aligns the capsule chamber (28) with the airway in the mouthpiece (11 ).

11. An inhaler (10) according to claim 1 , wherein said actuators (23) are placed at equal distances from an axis of symmetry of the carrier (16).

12. An inhaler (10) according to claim 1 , wherein said sidewalls (22) are placed at equal distances from an axis of symmetry of the body (13).

13. An inhaler (10) according to claim 1 , wherein said actuators (23) comprise a circulation part (15) that covers it like a lid and has a hole for the capsule to be placed in the capsule chamber (28).

14. An inhaler (10) according to claim 1 , wherein said circulation part (15) comprises at least one circulation guide (24) to create turbulence.

15. An inhaler (10) according to any of the preceding claims, wherein the cover (12), mouthpiece (11 ), body (13), carrier (16), circulation part (15), actuators (23) and side walls (22) are made of injection moldable plastics.

16. An inhaler (10) according to any of the preceding claims, wherein there is a carrier slot (36) comprising an opening in which the thinnest body part of shouldered pin can be placed.

Description:
AUTOMATIC DRY POWDER INHALER

FIELD OF THE INVENTION

The present invention relates to the field of drug inhalers and more particularly to capsule-based dry powder inhalers. In particular, the present invention relates to a device used to perforate the drug automatically.

BACKGROUND OF THE INVENTION

Inhalers are widely used in the pharmaceutical field for the treatment of respiratory diseases and other diseases. Drugs are inhaled into the lungs by using inhalers for rapid absorption into the bloodstream and local effect in the lung.

Inhaled drugs are divided into two major categories, one in gas form and the other in powder form. The choice of gas or powder depends on the properties of the drugs to be inhaled. The most common type of inhaler is the pressurized metered-dose inhalers. In this type of inhaler, the drug is commonly stored as a solution in a gascontaining pressurized can. Usually, the box is connected to a manually operated assembly. Upon activation, the pressurized dose inhaler releases a fixed dose of drug in aerosol form.

The other type referred to here is another type in the form of a dry powder inhaler and specifically a capsule-based dry powder inhaler. A metered dose of drug powder is released through the dry powder inhaler. In a capsule-based dry powder inhaler, drug is stored in a capsule inside the inhaler. The capsule is perforated by the user to release the drug before inhalation.

Capsule-based dry powder inhalers based on a significant interaction with the patient creates several challenges in terms of design and usability. In the field of dry powder inhalers, the challenges are being overcome by two major innovative approaches. The first approach prefers to develop sophisticated and mechanically complex devices; second approach prefers a simple construction approach that leads to high dispersion quality with the developments in powder technology and also easy handling and low cost.

First of all, the number of manual steps required from loading the capsule to inhalation should be desirably few, and the mechanical work steps between the inhaler components should be automated to facilitate the use of the device. However, automated mechanical work steps can cause a significant increase in manufacturing and design costs. Inhalers are often the most costly part of a pharmaceutical drug package. The developer is therefore faced with the dilemma of designing and producing an inhaler that is either very expensive to make but easy to use, or very difficult to use but inexpensive to make.

An inhaler should not only be designed to have a minimum number of components or to automate mechanical work steps while maintaining ease of use, but should also be designed for easy, economical, and high-speed industrial assembly. Since industrial assembly can represent a significant fraction of the cost, it is important for the developer to develop devices that can be easily assembled on an industrial scale.

The production of a self-automated device by reducing the number of components and minimizing manual handling allows to reduce the patient’s effort effectively in dispersion and drag forces and allows the most precise preparation of the unit dose of the pharmaceutical powder.

EP 3131611 B1 , a document known in the prior art, discloses a dry powder inhaler (1 ) for pulmonary or nasal use using capsules containing a dose of powder for inhalation, consisting of four main components such as a capsule tray (2), a cover (4) and a mouthpiece (8) and an inhaler body (3). The air is drawn by the patient through the mouthpiece (8), thus the powder dose is distributed and entrained. Capsule (6) is pierced by the piercing elements (18, 19) on the inhaler body (3). When the inhaler body (3), the mouthpiece (8), and the cover (4) are mounted to each other, the hinge sections (20, 35, 42) inside the mouthpiece (8) and the inhaler body (3) form a single hinge (5) and provides cover (4) to rotate freely around the inhaler body (3) and the mouthpiece (8). Another prior art document numbered EP 1809355 B2 describes an inhaler device for inhaling a drug from a pierceable capsule in the system. The inhaler device includes a slot for holding a drug capsule (10); a movable cover (3) to close the body, and piercing pins (7) to pierce the drug capsule. The movement of the cover (3) relative to the slot causes the movement of the piercing pins (7).

EP 2964297B1 discloses a dry powder inhaler (10) comprising a body (12) having a cover (14) and a lower body part (16), mouthpiece (20) where the medicament can be inhaled. The cover (14) is attached to the lower body (16) and is movable between a closed configuration where it covers the mouthpiece (20) and an open configuration where it leaves the mouthpiece (20) open. The inhaler (10) also includes a button (22) connected to the lower body (16) and a spring (82) that moves between this button (22) and the lower body (16). Said button (22) can move towards a position where it protrudes from the surface of the lower body (16). In use, the button (22) is moved from the intended position into the lower body (16) causing the medicament to be blasted for inhalation through the mouthpiece (20).

One object of the invention is to be able to blast the capsule automatically.

Another object of the invention is to ensure that the force used while detonating the capsule remains constant.

Another object of the invention is to enable the user to blast the capsule with minimal effort.

Another object of the invention is to ensure that the needles move from the same starting point to the same endpoint at a constant speed in each use of the device.

Another object of the invention is to enable the production of an easy, economical, and high-speed industrially assembled dry powder inhaler.

Contrary to the prior art, the present invention does not leave the detonation process to the user. While in other devices, differences in the user’s muscle strength during the detonation process may cause an obvious inconsistency, the present invention eliminates the said inconsistency. Generally, dry powder capsule detonating devices make holes on the capsule with the help of piercing elements located on opposite or parallel. This detonation process left to the user in cases where low force is applied, or the piercing needles cannot be pushed forward completely causes capsule not to be blasted and drug not to be inhaled correctly.

In the present invention, the detonation process is performed automatically. Thus, the errors caused by the user are eliminated and the appropriate dose of the drug is safely delivered to the user. Regardless of the user’s muscle strength, the capsule detonation process takes place with the movement of the capsule chamber.

BRIEF DESCRIPTION OF THE DRAWINGS

The figures, which are explained below, aim to exemplify the automatic dry powder inhaler in which advantages against prior art have been summarized and will be explained in detail later.

The drawings should not be interpreted as limiting in terms of the scope of protection defined in the claims and should be referenced simply in interpreting the scope of the said claims without referring to the technique in description.

Figure 1 : The automatic dry powder inhaler is shown according to one embodiment of the present invention.

Figure 2: Shows an automatic dry powder inhaler with the capsule chamber in open position according to one embodiment of the present invention.

Figure 3: A disassembled drawing of an automatic dry powder inhaler according to one embodiment of the present invention.

Figure 4: A vertical sectional view of an automatic dry powder inhaler according to one embodiment of the present invention.

Figure 5: Shows a carrier and an actuator mounted on it, according to an embodiment of the present invention.

Figure 6: The view of the actuator with the capsule chamber in the open position, according to an embodiment of the present invention. Figure 7: The view of the actuator as the capsule chamber is closing, according to an embodiment of the present invention.

Figure 8: The view of the actuator with the capsule chamber in the closed position, according to an embodiment of the present invention.

DETAILED DESCRIPTION OF THE INVENTION

For a better understanding of the present invention below, parts included in the figures included in the description of the invention are individually numbered and the description of each numbered part is shown below.

10) Inhaler

11 ) Mouthpiece

12) Cover

13) Body

14) Slot

15) Circulation part

16) Carrier

17) Cover hinge part

18) Body hinge part

19) Hinge shaft

20) Needle

21 ) Spring

22) Sidewalls 23) Actuator

24) Circulation guide

25) Needle path

26) Mouthpiece protrusion

27) Mouthpiece filter

28) Capsule chamber

29) Actuator slide

30) Actuator protrusion

31 ) Sidewall slide

32) Shaft

33) Actuator mounting

34) Actuator protrusion slot

35) Actuator slide slot

36) Carrier slot

Figure 1 shows the inhaler (10) of the present invention. Said inhaler (10) comprises a cover (12) and a body (13). Said cover (12) provides protection of the inhaler (10) and especially the mouthpiece (11 ) from the external environment. In addition, the rounded shape of the cover (12) and said body (13) ensures that said inhaler (10) is oval in shape. This oval structure offers safe transportation and easy use with its non-pointed tip and easy-to-grip form.

Figure 2 shows the open state of a carrier (16) and the mouthpiece (11 ). Said carrier (16) is opened with a circular motion. Thus, a capsule chamber (28) on the carrier (16) becomes ready to be filled and the capsule to be used is placed inside. Said capsule chamber (28) is in a form suitable for a general capsule form. With the same circular motion, said carrier (16) is closed, and the capsule becomes ready to be inhaled.

Figure 3 is a disassembled view in which all the components of the inhaler (10) can be inspected. The mouthpiece (11 ), which is completely covered by the cover(12), includes a mouthpiece protrusion (26). Said mouthpiece protrusion (26) is placed in a slot on the cover (12) and provides locking, thus opening of the cover (12) in non-sterile environments is prevented. With the angled structure of said mouthpiece protrusion (26), the cover (12) can be opened and closed easily by the user. There is an airway extending along the mouthpiece (11 ). The mouthpiece filter (27), which completely closes the airway in said mouthpiece (11 ), prevents undesirable sized particles coming out of the capsule from entering the respiratory tract. There are at least two sidewalls (22) adjacent to a slot (14) in the middle of said body (13). Said sidewalls (22) have a sidewall slide (31 ). In addition, the sidewalls (22) prevent the circulation part (15) from coming out of the slot (14) with the carrier (16) to be placed in said slot (14) and at least two actuators (23) on it. There are at least two actuator protrusion slots (34) and at least two actuator slide slots (35) on said carrier (16). Said actuator protrusion slot (34) and actuator slide slot (35) ensure that the actuator (23) is placed on the carrier (16) and fixed in such a way that it only allows its circular motion. This fixing process is completed by placing said circulation part (15) on the carrier (16) like a cover. In the middle of said circulation part (15), there is a hole for the capsule to be easily placed in the capsule chamber (28) and at least one circulation guide (24), to create an airflow that will enable easy inhalation of the drug powder. Said carrier (16) includes at least two carrier slots (36). Shouldered pins on the body (13) are placed inside said carrier slots (36). Thus, the carrier (16), one side of which is rotatably fixed and one side free, moves in a circular manner with a minimum force applied by the user. All parts are modularly interconnected with snap-fit extensions and slots. In the inhaler (10), which is the subject of the present invention, small screw-like parts that the user can accidentally inhale are not used.

Figure 4 shows a vertical section of the inhaler (10). A hinge shaft (19) ensures that the main parts of the inhaler (10) are hinged to each other in a way that the cover (12) can be opened by passing through the hole in the middle of a cover hinge part (17); which is a part of the cover (12) and a body hinge part (18); which is a part of the body (13). The longitudinal porous channel structure of said cover hinge part (17) and the body hinge part (18) and the rod-shaped hinge shaft (19) forming a longitudinal axis that allows the cover (12) to rotate.

The actuator (23) shown in Figure 5 is a multi-part assembly comprising several different components and comprises at least one needle (20), at least one spring (21 ), at least one actuator slide (29) and at least one actuator protrusion (30). Said actuator slide (29) and actuator protrusion (30) placed on the actuator protrusion slot (34) and actuator slide slot (35) on said carrier (16). Thus, together with the circular movement of the carrier (16), the actuator (23) also moves circularly. However, said actuator (23) not only moves in a circular motion together with the carrier (16), but also moves in an axis perpendicular to the diameter of said circular motion by pushing the actuator slide (29) on it towards the capsule by the sidewall slide (31 ). In addition, there are at least two needle paths (25) extending parallel to the long side of the capsule chamber (28). Said needle paths (25) allow the needles (20) to reach the capsule in the capsule chamber (28) and blast the capsule.

Figure 6 shows the first position, the position where the capsule chamber (28) is opened and the capsule is ready to be inserted. On the sidewall (22) there is a sidewall slide (31 ) located diagonally. Said sidewall slide (31 ) has a form that tapers towards the edge where it contacts the actuator slide (29) and can move on the actuator slide (29) with its curved, slippery surface. The contact surface between the semicircular actuator slide (29) and the sidewall slide (31 ), is reduced to the smallest area with its curved forms and its structure that tapers towards the edge of the sidewall slide (31 ). This friction-reducing system minimizes the force required by the user. In the first position, said actuator slide (29) is fully inserted between the sidewall slide (31 ) and the actuator mounting (33) on the body (13), and remains fixed if the user does not apply a certain force. In this position, a spring (21 ) wrapped on a shaft (32) has not yet been compressed and the needle (20) has not yet passed through the needle path (25) and blast the capsule.

Figure 7 is the second position, the position where the capsule is blasted. In this position, the user pushes the carrier (16) towards the slot (14) after placing the capsule in the capsule chamber (28). As a result of the pushing movement, the actuator (23) approaches the capsule by sliding on the sidewall slide (31 ) via the actuator slide (29). Thus, the actuator slide (29) and the sidewall slide (31 ) are compressed by said spring (21 ) and the needle (20) is allowed to move only enough to blast the capsule. The actuators (23) on both sides of the capsule chamber (28) move towards each other. Said needles (20) blast the capsule by passing through the needle paths (25) located on opposite short sides of the capsule chamber (28).

Figure 8 shows the third and final position, the position where the capsule is ready to be inhaled. After the capsule blasts, the actuator (23) continues to slide on the sidewall slide (31 ) and causes the carrier (16) to move towards the end of the slot (14). When the carrier (16) is fully closed, the spring (21 ) is not compressed as much as in the second position, the actuators (23) are separated from each other relative to the second position, and the actuator protrusions (30) and the sidewall slides (31 ) are in contact. Thus, the needle (20) is withdrawn from the needle path (25), preventing the user from breathing the needle (20), and the capsule chamber (28) is aligned with the airway in the mouthpiece (11 ). The user inhales the drug powder in the capsule chamber (28) through the mouthpiece (11 ). Through the mouthpiece filter (27), the inhalation of undesired particles in the blasted capsule is prevented. After inhaling the drug powder, the user can empty the remaining capsule parts at any time by opening the carrier (16). It is not necessary to open the cover (12) to perform the unloading process.

In summary, the inhaler (10) of the present invention has a system that is easy to use and automatically makes the capsule ready for inhalation. The user closes the carrier (16) after placing the capsule in the capsule chamber (28). During the closing process, the blast of the capsule is carried out automatically with the movement of the actuators (23). The user easily inhales the drug powder into his lungs through the mouthpiece (11 ).

In one embodiment of the invention, an inhaler(10) comprising a mouthpiece (11 ) comprising an airway, a cover (12) movable to close and open said mouthpiece (11 ) and comprising a cover hinge part (17), a carrier (16) having a capsule chamber (28) in which a dry powder capsule can be placed, a slot (14) in which said carrier (16) can be placed, and a body (13) comprising a body hinge part (18) is proposed. In another embodiment of the present invention, there is a carrier (16) that can be placed in the slot (14) in said body (13) and can move around one edge in a circular manner.

In another embodiment of the present invention, there are at least two actuators (23), which can be placed on said carrier (16) and can get closer to each other by moving in an axis perpendicular to the diameter of said circular motion.

In another embodiment of the present invention, there is an actuator slide (29) in the form of a protrusion on the actuator (23) that provides said vertical movement.

In another embodiment of the present invention, there are at least two side walls (22) that push the actuator slide (29) towards the capsule chamber (28) during said circular motion, and which can be inserted into said body (13) and each of which has sidewall slide (31 ) in the form of protrusions.

In another embodiment of the present invention, there are at least two mutually extended needles (20) that move together with said actuator (23) and can reach said capsule chamber (28).

In another embodiment of the present invention, said capsule chamber (28) has at least two needle paths (25) in the form of openings on its two opposite sides.

In another embodiment of the present invention, the inhaler (10) comprises a spring (21 ) that is compressed on the actuator (23) that moves while passing over the sidewall slide (31 ) during the opening and closing of said carrier (16).

In another embodiment of the present invention, said spring (21 ) pushes the actuator (23) towards the surface of the sidewalls (22).

In another embodiment of the present invention, said sidewall slide (31 ) extends diagonally on the sidewall (22).

In another embodiment of the present invention, said sidewall slide (31 ) has a form that tapers towards its periphery.

In another embodiment of the present invention, said sidewall slide (31 ) has a circular form. In another embodiment of the present invention, said actuator slide (29) has a circular form.

In another embodiment of the present invention, said body (13) comprises at least two actuator mounting (33) that prevent the actuator slide (29) from coming out of said slot (14) when said carrier (16) is open.

In another embodiment of the present invention, said actuator (23) comprises an actuator protrusion (30) that aligns the capsule chamber (28) with the airway in the mouthpiece (11 ).

In another embodiment of the present invention, the actuators (23) are placed at equal distances from an axis of symmetry of the carrier (16).

In another embodiment of the present invention, said sidewalls (22) are placed at equal distances from an axis of symmetry of the body (13).

In another embodiment of the present invention, said actuators (23) comprise a circulation part (15) that covers it like a lid and has a hole for the capsule to be placed in the capsule chamber (28).

In another embodiment of the invention, said circulation part (15) comprises at least one circulation guide (24) to create turbulence.

In another embodiment of the invention, the cover (12), mouthpiece (11 ), body (13), carrier (16), circulation part (15), actuators (23) and side walls (22) are made of injection moldable plastics.

In another embodiment of the present invention, there is a carrier slot (36) comprising an opening in which the thinnest body part of shouldered pin can be placed