Device for nasal delivery of fluid products

Abstract

An apparatus includes: a fluid product container (10) containing a dose of fluid product; a compressed gas container (20) adapted to dispense a dose of compressed gas to discharge a dose of fluid product; and an intermediate portion (30) including a body (31), connecting devices (40, 50, 60) for connecting the fluid product container (10) to the compressed gas container (20), and actuating devices (35, 36) for actuating the device, the connecting devices including: a second support member (50) and a first support member (40), and a deformable tube (60) attached to both the first support member (40) and the second support member (50), the first support member (40) including a first opening device (45) for opening the fluid product container in an actuated position. (10), and the second support member (50) includes a second opening device (55) for opening the compressed gas container (20) in an actuated position, a loading spring (70) is disposed between the first support member (40) and the second support member (50), the actuating device includes an actuation button (35) rigidly connected to the hollow cage (36), the hollow cage (36) axially locking the first support member (40) and the second support member (50) in their respective rest positions in the rest position, and when the actuation button (35) moves radially to its actuated position, the first support member (40) and the second support member (50) axially unlock, and the spring (70) moves the first support member (40) and the second support member (50) to their respective actuated positions.

Description

Technical Field

[0001] The present invention relates to an apparatus for delivering a fluid product to the nose, and more specifically, to an apparatus for dispensing a dose of a pharmaceutical fluid product contained in a container into the nostrils using a pressurized airflow, wherein the pharmaceutical fluid product is a liquid or a powder. Background Technology

[0002] Documents WO9946055 and WO0245866 disclose nasal delivery devices in which a spherical closure element blocking the container outlet is expelled by an airflow generated by a user-manually actuated air purge. A drawback of this type of device is the manual air purge mechanism, which, in the example of WO9946055, delivers a variable airflow depending on the actuation device. Document WO0245866 addresses this issue by proposing a mechanical opening at the actuated end position; however, it has been shown that actuation of the air purge can be difficult for susceptible individuals to ensure sufficient airflow.

[0003] Reference WO2020154182 proposes using a compressed gas container instead of manual air purging, which opens during actuation to dispense a dose of fluid product. The device includes a double-pointed needle, which pierces both the fluid product container and the compressed gas container when the user presses the bottom of the container, allowing the compressed gas to dispense a dose of the fluid product. A disadvantage of this implementation is that axial force must be applied when the device is in the user's nose, posing a risk of discomfort or injury during the triggering of the compressed gas flow.

[0004] Document US2020121871 describes another prior art device. Summary of the Invention

[0005] One object of the present invention is to provide an apparatus for delivering fluid products to the nose that does not have the above-mentioned defects.

[0006] In particular, the object of the present invention is to provide an apparatus that ensures the dispensing of a fluid product independently of speed or actuation force.

[0007] Another object of the present invention is to provide a device that prevents any risk of nasal injury during actuation.

[0008] Another objective of this invention is to provide an apparatus that is simple to manufacture, assemble, fill, and use, and is low in cost.

[0009] Therefore, the object of the present invention is to provide a fluid product dispensing device comprising: a container holding a predetermined dose of fluid product to be dispensed; a compressed gas container adapted to dispense a predetermined dose of compressed gas to discharge a predetermined dose of fluid product during actuation; and an intermediate portion comprising a main body, a connecting device for connecting the fluid product container to the compressed gas container, and an actuating device for actuating the device, the connecting device comprising a first support member and a second support member axially movable relative to the main body, and a flexible deformable tube attached to both the first support member and the second support member, the first support member comprising a means for opening the fluid product in an actuated position. The container has a first opening device and a second support member, each including a second opening device for opening the compressed gas container in an actuated position. A loading spring is disposed between the first and second support members for elastically pushing the first and second support members to their respective actuated positions. The actuating device includes an actuation button that is radially movable between a rest position and an actuated position. The actuation button is rigidly connected to a hollow cage. In the rest position of the actuation button, the hollow cage axially locks the support members in their respective rest positions. When the actuation button is radially moved to its actuated position, the support members are axially unlocked, and the spring moves the two support members to their respective actuated positions.

[0010] According to the first advantageous variant, the fluid product container contains a single dose of fluid product.

[0011] Advantageously, the first opening device includes a first needle connected to the flexible tube, and in the actuated position, the first needle pierces the membrane of the fluid product container.

[0012] According to the first advantageous variant, the compressed gas container holds a single dose of compressed gas.

[0013] Advantageously, the second opening device includes a second needle connected to the flexible tube, and in the actuated position, the second needle pierces the membrane of the compressed gas container.

[0014] According to a second advantageous variant, the compressed gas container holds several doses of compressed gas.

[0015] Advantageously, the second opening device includes a valve well connected to the flexible tube and engaged with a valve of a metering valve mounted on the compressed gas container.

[0016] Advantageously, the hollow cage includes an upper axial wall and a lower axial wall, each axial wall including a wall portion and an axial opening.

[0017] Advantageously, in the rest position, the upper axial edge of the first support member is axially locked by the wall portion of the upper axial wall, and the lower axial edge of the second support member is axially locked by the wall portion of the lower axial wall.

[0018] Advantageously, when the actuation button is moved radially to its actuated position, the axial opening of the upper axial wall is positioned facing the upper axial edge of the first support member, and the axial opening of the lower axial wall is positioned facing the lower axial edge of the second support member.

[0019] Advantageously, in the rest position, the flexible tube deforms and / or twists, and when the two support members move axially relative to each other to their respective actuated positions, the flexible tube straightens to compensate for the axial clearance generated between the two support members during actuation.

[0020] Advantageously, during actuation, the fluid product container and the compressed gas container open simultaneously.

[0021] In one variation, the fluid product container opens just before the compressed gas container during actuation.

[0022] Advantageously, the container is of the BFS (Blow-Fill-Seal) or FFS (Form-Fill-Seal) type, i.e., produced continuously by blowing or forming, filling and sealing.

[0023] Advantageously, the container includes an attachment device for attaching the container to the intermediate portion, in particular, for detachably attaching the container to the intermediate portion. Attached Figure Description

[0024] These features and advantages, as well as other features and advantages, will become clearer in the detailed description below, with reference to the accompanying drawings given as non-limiting examples, wherein:

[0025] Figure 1 This is a schematic vertical sectional view of the apparatus for dispensing fluid products according to a first advantageous embodiment before actuation.

[0026] Figure 2 It is similar to Figure 1 The view shows the view after actuation.

[0027] Figure 3 and Figure 4 Is with Figure 1 and Figure 2 Similar views, viewed from different angles.

[0028] Figure 5 yes Figure 3 A detailed schematic vertical sectional view of the device.

[0029] Figure 6 yes Figure 4 A detailed schematic vertical sectional view of the device.

[0030] Figure 7 This is a schematic top horizontal cross-sectional view of the middle section before actuation.

[0031] Figure 8 It is similar to Figure 7 The view shows the view after actuation.

[0032] Figure 9 This is a schematic perspective view of a device for dispensing fluid products according to a second advantageous embodiment before actuation.

[0033] Figure 10 yes Figure 9 A schematic three-dimensional cross-sectional view of the device after actuation. Detailed Implementation

[0034] It should be understood that in the following description, the terms "upper," "lower," "top," "bottom," "vertical," and "horizontal" refer to... Figures 1 to 4 , Figure 9 and Figure 10 The device is shown in its upright position. The terms "axial" and "radial" refer to the longitudinal central axis A of the device, as shown in the figure. Figure 1 As shown.

[0035] The device comprises three main parts: a container 10 which holds a dose of fluid product to be dispensed, particularly a drug in powder or liquid form; a compressed gas container 20 adapted to dispense a dose of compressed gas during actuation to expel a dose of fluid product during actuation; and an intermediate section 30 which connects the container 10 to the compressed gas container 20 and enables actuation of the device.

[0036] The container 10 can be directly formed in an axially elongated dispensing head 11, the axial end of which includes a dispensing hole 12, and the dispensing head 11 is for insertion into a user's nostril, as shown in the example in the figure. In a variant, the container can be detached from the dispensing head.

[0037] In the preferred embodiment shown in the figure, the container 10 is of the BfS (Blow-Fill-Seal) or FFS (Form-Fill-Seal) type, that is, the container 10 is produced continuously by blowing or forming, filling and sealing, preferably in a sterile enclosure.

[0038] The dispensing hole 12 is closed by a removable plug 15, which is removed before using the device. After the plug 15 is removed, the dispensing hole 12 is opened.

[0039] On the side opposite to the axial direction of the dispensing orifice 12, the container 10 is closed by a membrane 17, which is adapted to be opened during actuation, in particular to be punctured, as will be described below.

[0040] Advantageously, the reservoir 10 includes a fastening device 16 for securing the reservoir 10 to the intermediate portion 30. This attachment may be non-removable when the device is for single use and can be discarded after actuation. In a variant, the attachment may be removable when the device is reusable, allowing a full container to replace an empty one. An example of a removable attachment is the Luer-type rotary attachment known in the field of syringes.

[0041] exist Figures 1 to 6 In the first embodiment shown, the compressed gas container 20 contains a single dose of compressed gas. In this case, if the device is disposable and can be discarded after use, the compressed gas container 20 may not be detachable from the intermediate portion 30. In a variant, when the device is reusable, the compressed gas container 20 may be detachable, allowing a full gas container 20 to replace an empty one.

[0042] In this first embodiment, the compressed gas container 20 is sealed by a membrane 21, which is adapted to be opened during actuation, in particular to be punctured, as will be described below.

[0043] exist Figure 9 and Figure 10 In the second embodiment shown, the compressed gas container 20 contains several doses of compressed gas.

[0044] In this configuration, the compressed gas container 20 preferably includes a metering valve 25 comprising a valve 26 that is axially movable within the valve body during actuation to dispense a measured dose of compressed gas. Thus, the compressed gas container 20 opens when the valve 26 is moved to its actuated position by axial pressure within the valve body in a known manner. Operating a metering valve with compressed gas is known, and in this context, any existing type of metering valve 25 will not be described in further detail.

[0045] The intermediate portion 30 includes a body 31 having an upper body portion 32 and a lower body portion 33. The upper body portion 32 advantageously includes a complementary attachment device of the attachment device 16 of the container 10, such as a standard attachment device of the Luer type. The lower body portion 33 houses the compressed gas container 20.

[0046] The actuation button 35 is radially slidably mounted in the body 31 between a rest position and an actuated position, wherein the actuation button 35 is radially pressed into the interior of the body 31. The actuation button 35 is rigidly connected to the hollow cage 36.

[0047] Advantageously, the hollow cage 36 includes an upper axial wall 37 and a lower axial wall 38, each axial wall 37, 38 including wall portions 371, 381 and axial openings 372, 382, ​​which can... Figures 5 to 8 I saw it in the middle.

[0048] The main body 31 of the intermediate portion 30 houses a first support member 40 and a second support member 50, which are arranged around each other by means of axial mobility relative to the main body 31. The first support member 40 is axially upward movable between its rest position and its actuated position, and the second support member 50 is axially downward movable between its rest position and its actuated position.

[0049] The first support member 40 includes an upper axial edge 41, and the second support member 50 includes a lower axial edge 51.

[0050] The flexible deformable tube 60 is attached to both the first support member 40 and the second support member 50. In the rest position, the flexible tube deforms and / or twists, and when the two support members 40, 50 move axially relative to each other to their respective actuated positions, the flexible tube 60 straightens, thereby compensating for the axial clearance generated between the two support members 40, 50 during actuation.

[0051] The first support member 40 includes a first opening device 45 for the fluid product container 10. In the example shown, this first opening device includes a first needle 45 connected to the flexible tube 60, and in the actuated position, the first needle 45 pierces the membrane 17 of the container 10.

[0052] The second support member 50 includes a second opening device 55 for the compressed gas container 20. Figures 1 to 6 In the example shown, these second opening devices include a second needle 55 connected to the flexible tube 60, and in the actuated position, the second needle 55 pierces the membrane 21 of the compressed gas container 20.

[0053] Therefore, in the actuated position, the contents of the compressed gas container 20 are connected to the contents of the fluid product container 10 via two needles 55, 45 and a flexible tube 60, thereby ensuring that the fluid product is dispensed through the dispensing orifice 12.

[0054] A loading spring 70 is disposed between the first support member 40 and the second support member 50 for elastically pushing the first support member 40 and the second support member 50 to their respective actuation positions.

[0055] In the rest position of the actuation button 35, the hollow cage 36 locks the support members 40 and 50 in their rest positions, and when the actuation button 35 moves radially to its actuated position, the support members 40 and 50 unlock, and the spring 70 moves the two support members 40 and 50 to their respective actuated positions. Thus, actuation of the side actuation button 35 simultaneously opens the fluid product container and the compressed gas container 20. Optionally, particularly by adjusting the corresponding positions of the two support members 40 and 50, it can be ensured that during actuation, the fluid product container 10 opens just before the compressed gas container 20 opens.

[0056] The characteristics of the spring 70, particularly its stiffness and / or the force it exerts on the two support members 40, 50 during actuation, allow the performance of the spray generated at the outlet of the dispensing orifice 12 to be predetermined.

[0057] Other parameters also affect these properties of the spray, particularly the volume and pressure of the dose of compressed gas delivered during actuation, and the volume of the fluid product contained in container 10.

[0058] Advantages, such as Figure 7 As shown, in the rest position, the upper axial edge 41 of the first support member 40 abuts the wall portion 371 of the upper axial wall 37 of the cage 36, and the lower axial edge 51 of the second support member 50 abuts the wall portion 381 of the lower axial wall 38 of the cage 36.

[0059] When the actuation button 35 moves radially to its actuation position, such as Figure 8 As shown, the axial opening 372 of the upper axial wall 37 of the cage 36 is positioned facing the upper axial edge 41 of the first support member 40, and the axial opening 382 of the lower axial wall 38 of the cage 36 is positioned facing the lower axial edge 51 of the second support member 50. Therefore, the two support members 40, 50 are no longer axially locked, and the spring 70 moves each support member 40, 50 to its corresponding actuated position.

[0060] When the user wishes to use the device, the user first removes the plug 15 from the dispensing hole 12 of container 10 and places the dispensing head into the nostril. The user then presses the actuation button 35, an actuation movement that is lateral and non-axial, thereby radially moving the cage 36 within the body 31 and axially releasing the two support members 40, 50. Thus, the spring 70 is automatically actuated by the compressed gas contained in the compressed gas container 20 and dispenses the dosage of the fluid product contained in container 10.

[0061] If the device is for single use only, discard it after use.

[0062] In a variant, the intermediate section 30 can be reused by replacing the empty fluid product container 10 with a new fluid product container 10 and by replacing the empty compressed gas container 20 with a new compressed gas container 20. In this case, the actuation button 35 advantageously includes a re-arming device to return the actuation button to its rest position after each actuation. Advantageously, these re-arming devices include elastic elements, such as a second spring. Preferably, the force applied by the second spring is greater than the force applied by the spring 70, thereby automatically re-arming first by returning the actuation button 35 to its rest position, and also by refilling the spring 70 to return the two support members 40, 50 to their respective rest positions.

[0063] exist Figure 9 and Figure 10 In the second embodiment shown, a compressed gas container 20 is used, which holds several doses of compressed gas, so the device is reusable and the container 10 is replaced after each actuation.

[0064] In this second embodiment, the second support member 50 does not include a needle for piercing the membrane, but instead engages with valve 26 of a metering valve 25 mounted on the compressed gas container 20. Thus, upon each actuation, a dose of compressed gas is delivered to dispense the fluid product contained in the container 10.

[0065] In cases where the device is reusable, the actuation button 35 includes refitting devices to return the actuation button to its rest position after each actuation. Advantageously, these refitting devices include elastic elements, such as a second spring. Preferably, the force applied by the second spring is greater than the force applied by the spring 70, such that refitting is performed automatically first by returning the actuation button 35 to its rest position, and also by refilling the spring 70 to return the two support members 40, 50 to their respective rest positions.

[0066] The device according to the invention improves the dispensing of fluid products into the nostrils by enabling the fluid product to reach the furthest parts, such as the sieve openings.

[0067] In particular, the device according to the invention is suitable for treating allergic rhinitis and central pain syndrome.

[0068] Within the scope of allergic rhinitis, fluid products may be selected from the following list, given as non-limiting examples: fluticasone, mometasone, fluticasone furoate, budesonide, beclometasone, azelastine fluticasone, azelastine, tixocortol, triamcinolone acetonide, ipratropium bromide, prednisolone, ciclesonide, flunisolide, levocabastine, azelastine fluticasone furoate, olopatadine, azelastine mometasone, mometasone olopatadine. olopatadine and fluticasone olopatadine.

[0069] Within the scope of central pain syndromes, fluid products may be selected from the following list, given as non-limiting examples: sumatriptan, zolmitriptan, naloxone, fentanyl, esketamine, midazolam, butorphanol, dihydroergotamine, diazepam, tapentadol, alfentanil, diamorphine, and ketorolac.

[0070] The invention has been described with reference to various embodiments and variations, but it should be understood that any modifications may be made thereto by those skilled in the art without departing from the scope of the invention as defined by the appended claims.

Claims

1. An apparatus for dispensing fluid products, comprising: A fluid product container (10) contains a certain dose of fluid product to be dispensed; A compressed gas container (20) adapted to dispense a dose of compressed gas to discharge the dose of fluid product during actuation; and The intermediate portion (30) includes a main body (31), connecting devices (40, 50, 60) for connecting the fluid product container (10) to the compressed gas container (20), and actuating devices (35, 36) for actuating the device. The connecting device is characterized by comprising: a second support member (50) and a first support member (40) axially movable relative to the body (31), and a flexible deformable tube (60) attached to both the first support member (40) and the second support member (50). The first support member (40) includes a first opening device (45) for opening the fluid product container (10) in an actuated position, and the second support member (50) includes a second opening device (55) for opening the compressed gas container (20) in the actuated position. A loading spring (70) is disposed between the first support member (40) and the second support member (50) for connecting the first support member (40) and the second support member (50). The actuating device includes an actuation button (35) that is radially movable between a rest position and an actuation position. The actuation button (35) is rigidly connected to a hollow cage (36). The hollow cage (36) axially locks the first support member (40) and the second support member (50) in their respective rest positions in the rest position of the actuation button (35). When the actuation button (35) moves radially to its actuation position, the first support member (40) and the second support member (50) are axially unlocked, and the loading spring (70) moves the first support member (40) and the second support member (50) to their respective actuation positions.

2. The apparatus according to claim 1, wherein, The fluid product container holds a single dose of fluid product.

3. The apparatus according to claim 1 or 2, wherein, The first opening device (45) includes a first needle connected to the flexible deformable tube (60), and at the actuation position, the first needle pierces the membrane (17) of the fluid product container (10).

4. The apparatus according to claim 1 or 2, wherein, The compressed gas container (20) contains a single dose of compressed gas.

5. The apparatus according to claim 4, wherein, The second opening device (55) includes a second needle connected to the flexible deformable tube (60), and at the actuated position, the second needle pierces the membrane (21) of the compressed gas container (20).

6. The apparatus according to claim 1 or 2, wherein, The compressed gas container (20) contains several doses of compressed gas.

7. The apparatus according to claim 6, wherein, The second opening device (55) includes a valve well connected to the flexible deformable tube (60) and engaged with a valve (26) of a metering valve (25) mounted on the compressed gas container (20).

8. The apparatus according to claim 1 or 2, wherein, The hollow cage (36) includes an upper axial wall (37) and a lower axial wall (38), each of which includes a wall portion (371, 381) and an axial opening (372, 382).

9. The apparatus according to claim 8, wherein, In the rest position, the upper axial edge (41) of the first support member (40) is axially locked by the wall portion (371) of the upper axial wall (37), and the lower axial edge (51) of the second support member (50) is axially locked by the wall portion (381) of the lower axial wall (38).

10. The apparatus according to claim 9, wherein, When the actuation button (35) moves radially to its actuation position, the axial opening (372) of the upper axial wall (37) is configured to be positioned facing the upper axial edge (41) of the first support member (40), and the axial opening (382) of the lower axial wall (38) is configured to be positioned facing the lower axial edge (51) of the second support member (50).

11. The apparatus according to claim 1 or 2, wherein, In the rest position, the flexible deformable tube (60) deforms and / or twists, and when the first support member (40) and the second support member (50) move axially relative to each other to their respective actuated positions, the flexible deformable tube (60) is configured to straighten to compensate for the axial gap generated between the first support member (40) and the second support member (50) during actuation.

12. The apparatus according to claim 1 or 2, wherein, During actuation, the fluid product container (10) and the compressed gas container (20) are configured to open simultaneously.

13. The apparatus according to claim 1 or 2, wherein, During actuation, the fluid product container (10) is configured to open just before the compressed gas container (20).

14. The apparatus according to claim 1 or 2, wherein, The fluid product container (10) is of type BFS or FFS, meaning it is produced continuously by blowing or forming, filling and sealing.

15. The apparatus according to claim 1 or 2, wherein, The fluid product container (10) includes an attachment device (16) for attaching the fluid product container (10) to the intermediate portion (30).

16. The apparatus according to claim 15, wherein, The attachment device (16) detachably attaches the fluid product container (10) to the intermediate portion (30).

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