WO2022081100A1

WO2022081100A1 - Inhalation device

Info

Publication number: WO2022081100A1
Application number: PCT/TR2020/050932
Authority: WO
Inventors: Yilmaz Albukrek
Original assignee: Bi̇med Tekni̇k Aletler Sanayi̇ Ve Ti̇caret Anoni̇m Şi̇rketi̇
Priority date: 2020-10-12
Filing date: 2020-10-12
Publication date: 2022-04-21
Also published as: EP4240455A1; EP4240455A4

Abstract

The invention is an inhalation device (A) comprising a body (10) having at least one housing (11) in which the capsule containing the pharmaceutical composition is placed, a mouthpiece (20) which is attached to the body (10) and providing the inhalation of the pharmaceutical composition in the capsule and at least one needle (40) which provides puncturing of the capsule, in that it comprises at least one puncturing mechanism (50) which enables the needle (40) to move both in the linear axis and to rotate around its own axis.

Description

INHALATION DEVICE

Technical Field

The present invention relates to inhalation devices used for inhalation of pharmaceutical compositions that are useful for treating respiratory diseases such as asthma, bronchitis, COPD (Chronic Obstructive Pulmonary Disease).

In particular, the invention relates to the inhalation device and the puncturing mechanism that enables the pharmaceutical composition in powder form in the capsule to be taken by inhalation.

Background of The Invention

Despite the advances in diagnosis and treatment in recent years, diseases such as asthma, bronchitis and COPD significantly reduce the quality of human life. The deterioration of environmental conditions, bad habits and genetic factors increase the rate of encountering these problems day by day.

Medicaments suitable for inhalation are used in the treatment of many respiratory diseases, especially asthma and COPD. Some advantages of medicament use via inhalation are that more effective treatment can be provided by using less medicaments, higher concentrations of medicaments can be administered to the respiratory system, and systematic side effects of medicaments can be reduced. Various inhalation devices are designed to ensure adequate delivery of these drugs to the patient. These inhalation devices differ from each other due to their mechanisms and components.

Dry powder inhalation devices basically comprise mouthpiece, body and puncturing mechanism. In dry powder inhalation devices, the capsule is punctured with puncturing means and become ready for inhalation. After the puncturing, the pharmaceutical composition in powder form contained in the capsule is inhaled through the dry powder inhalation device. Dry powder inhalation devices are small, easy to use, contain fewer parts and are economical because they can be reused.

US3991761 discloses an inhalation device comprising a body and a mouthpiece, suitable for the administration of powdered medicaments contained in the capsule. It is of the uttermost importance that as much as possible of the medication contained in the capsules is inhaled. Ideally, the capsule should be entirely empty after inhalation. For this purpose, different puncturing mechanisms are developed in the state of the art.

EP3138601 discloses a dry powder inhaler for a capsule containing powder. The dry powder inhaler comprises a housing with a capsule receptacle, two actuator buttons arranged on opposite sides of the housing, and two needles. Each needle is fixedly attached to an actuator button and moved from the normal position to the puncturing position to puncture the capsule. A first end of each actuator button is connected to the lower portion of the housing. A second free end of each actuator button moves the needle along a circular line to the puncturing position.

During the puncturing process, it is common for the capsule to be damaged or detached the cut-out portion of the capsule from the capsule. In this case, the capsule pieces reach the respiratory system of the patient and cause discomfort. On the other hand, the size and shape of the holes created in the capsule have a significant effect on the delivery of the pharmaceutical composition to the respiratory system of the patient. During the puncturing process, damage of the capsule causes the pharmaceutical composition to reach the patient very quickly. A smaller than necessary diameter of the hole in the capsule or reclosing of the cut-out portion of the capsule limit the outflow of pharmaceutical composition in the capsule. In both cases, the repeatability of the administered dose and the effectiveness of the treatment decrease.

As a result, due to above described disadvantages and inadequacy of existing solutions, it has been necessary to make development in the related art.

Purpose of The Invention

The invention has been developed with inspiration from existing situation and purposes to eliminate the above-mentioned disadvantages.

The main purpose of the invention is to develop an inhalation device and puncturing mechanism so that the required dose can be administered to the patient in a repeatable manner. The puncturing mechanism of the present invention assists the required dose to reach the patient by ensuring proper puncturing of the capsule.

Another purpose of the invention is to provide the capsule puncturing process to be performed effectively and without shattering the capsule. The cut-out portion of the capsule punctured by the puncturing mechanism of the present invention remains attached to the capsule as a hinge or a flap. The hinge or flap shaped capsule portion is permanently bent, preventing it from closing or obstructing the hole.

Another purpose of the invention is to carry out the puncturing process independent of needle sharpening angle. The puncturing mechanism of the present invention enables the needle to move in a linear axis while at the same time allowing it to perform a rotational movement. Thus, the puncturing process is carried out independent of the needle sharpening angle.

Another purpose of the invention is to ensure that the user does not feel the rotational movement of the needle. In the present invention, the disk is added to the button in the puncturing mechanism. In this way, the user does not feel the rotational movement of the needle. Also, the disc also prevents the user from restraining the rotational movement.

In order to fulfill the objectives described above, the invention is an inhalation device comprising a body having at least one housing in which the capsule containing the pharmaceutical composition is placed, a mouthpiece which is attached to the body and providing the inhalation of the pharmaceutical composition in the capsule and at least one needle which provides puncturing of the capsule, in that it comprises at least one puncturing mechanism which enables the needle to move both in the linear axis and to rotate around its own axis.

The structural and characteristic features and all advantages of the invention will be clarified with the detailed description of the figures and the following description. Therefore, the evaluation should be done by taking into account these figures and detailed explanation.

Brief Description of Figures

Figure 1 : is an exploded view of the inhalation device.

Figure 2: is a general view of the button.

Figure 3: is a general view of the button plate. Description of Part References

A. Inhalation device

10. Body

11 . Housing

20. Mouthpiece

30. Cap

40. Needle

50. Puncturing mechanism

51. Spring

52. Button

53. First rotation element

54. Protrusion

55. Disc

56. Button Plate

57. Second rotation element

58. Aperture

Detailed Description of The Invention

In this detailed description, the preferred embodiments of an inhalation device (A) disclosed under the invention have been disclosed solely for the purpose of better understanding of the subject.

Referring to Figure 1 , the inhalation device (A) comprises a body (10) which a capsule is placed, a mouthpiece (20) which allows the patient to inhale the pharmaceutical composition in the capsule, and a cap (30). The inhalation device (A) furthermore comprises at least one needle (40) which punctures the capsule and at least one puncturing mechanism (50) which allows the needle (40) to move on a linear axis while rotating around its own axis.

The body (10) of the inhalation device (A) comprises at least one housing (11 ) for placing a capsule. There is at least one air flow channel (not shown in the figures) on the body (10) in connection with the housing (11 ). The air flow channel provides air entry into the body (10) during inhalation. When the punctured capsule is inhaled by the patient, the air entering through the air flow channel creates a vortex in the housing (11 ) and provides the pharmaceutical composition to reach the patient's lungs.

The pharmaceutical composition is inhaled by the patient through the opening on the mouthpiece (20). The mouthpiece (20) is attached to the body (10) by means of at least one connection element. In preferred embodiments of the invention, the mouthpiece (20 pivots around the body (10). With the pivoting movement, the mouthpiece (20) can move between the opening and closing positions. The opening position can be defined as moving the mouthpiece (20) away from the body (10). When the mouthpiece (20) is in the opening position, the housing (11) becomes visible. The closing position can be defined as the overlap of the mouthpiece (20) and the body (10). The cap (30) protects the mouthpiece (20) when the inhalation device (A) is not used for inhalation.

The inhalation device (A) has at least one puncturing mechanism (50). The puncturing mechanism (50) punctures the capsule by moving at least one needle (40) and the capsule becomes ready for inhalation. The puncturing mechanism (50) enables the needle (40) to move on a linear axis while rotating on its own axis between 0 - 360°. In alternative embodiments of the invention, the needle (40) rotates around its own axis between 0 - 180°, preferably 0 - 90°. In preferred embodiments of the invention, the needle (40) is made of a pharmaceutically acceptable stainless steel or abrasion resistant rigid plastic material. The puncturing mechanism (50) basically comprises at least one spring (51), at least one button (52), and at least one button plate (56).

Referring to Figure 2, the puncturing mechanism (50) comprises at least one button (52) that enables the needle (40) to move towards the puncturing position. When a force is applied to the button (52), the needle (40) moves towards the capsule in the housing (11 ). The spring (51 ) is compressed by the force applied to the button (52) and brings the needle (40) to the puncturing position of the capsule. When the force applied to the button (52) disappears, the spring (51) and the needle (40) return to their original position. The needle (40) can be moved by the spring (51 ) on a linear axis. Depending on the position of the button (52) and the needle (40) on the body (10), this movement can be performed as back-forth or up-down. At least one first rotation element (53) located on the button (52) assists the needle (40) to rotate around its own axis. During the rotation of the needle (40) around its own axis, the second rotation element (57) guides the first rotation element (53). In a preferred embodiment of the invention, the first rotation element (53) is in the form of a helical channel extending along the button (52). When force is applied on the button (52), the first rotation element (53), preferably in the form of a helical channel, is guided by the second rotation element (57), preferably in the form of a protrusion. Thus, the needle (40) moving in the linear axis also moves by rotating. There is at least one protrusion (54) on the button (52) that prevents the button (52) from removing. In preferred embodiments of the invention, the button (52) has at least one disc (55). Thus, the user does not feel the rotational movement of the needle (40). The disc (55) also prevents the user from restraining the rotational movement.

Referring to Figure 3, the puncturing mechanism (50) has at least one button plate (56) which enables the button (52) to be kept in the body (10). In preferred embodiments of the invention, the button plate (56) can be integrated to or replaced from the body (10). The button plate (56) also assists the needle (40) to rotate. There is at least one second rotation element (57) on the button plate (56). The second rotation element (57) guides the first rotation element (53) and enables the needle (40) to rotate around its own axis. In the preferred embodiment of the invention, the second rotation element (57) is in the form of a protrusion. There is an aperture (58) on the button plate (56) through which the button (52) can pass. The button plate (56) assists to keep the parts forming the puncturing mechanism (50) in the body (10).

Claims

7

CLAIMS An inhalation device (A) comprising;

- a body (10) having at least one housing (11) in which a capsule containing a pharmaceutical composition is placed,

- a mouthpiece (20) which is attached to the body (10) and providing the inhalation of the pharmaceutical composition in the capsule,

- and at least one needle (40) which punctures the capsule characterized in that, the inhalation device (A) comprises at least one puncturing mechanism (50) which enables the needle (40) to move both in the linear axis and to rotate around its own axis. An inhalation device (A) according to claim 1 , characterized in that the puncturing mechanism (50) comprises at least one spring (51 ) that enables the needle (40) to move on the linear axis. An inhalation device (A) according to claim 1 , characterized in that the puncturing mechanism (50) comprises at least one button (52) that enables the needle (40) to move towards the puncturing position. An inhalation device (A) according to claim 1 , characterized in that the puncturing mechanism (50) comprises at least one first rotation element (53) located on the button (52) and assisting the needle (40) to rotate around its axis. An inhalation device (A) according to Claim 1 , characterized in that the puncturing mechanism (50) comprises at least one button plate (56) which enables the button (52) to be kept in the body (10). An inhalation device (A) according to Claim 1 , characterized in that the puncturing mechanism (50) comprises at least one second rotation element (57) located on the button plate (56) and guiding the first rotation element (53). 8 An inhalation device (A) according to Claim 3, characterized in that it comprises at least one protrusion (54) located on the button (52) and preventing the button (52) from removing. An inhalation device (A) according to Claim 3, characterized in that it comprises at least one disc (55) located on the button (52) which enables the user not to feel the rotational movement of the needle and prevents the rotational movement from restraining. An inhalation device (A) according to claim 5, characterized in that the button plate (56) comprises at least one aperture (58) that allows passage of at least one button (52). An inhalation device (A) according to Claim 1 , characterized in that it comprises a cap (30) covering and protecting the mouthpiece (20).