Device for testing medicament inhalers

Abstract

A device for testing medicament inhalers, comprises: a sampling tube (2) having an inlet (3) configured to be connected to a mouth of a medicament inhaler (4), an outlet (5) opposite the inlet (3) and a plurality of seats (27) made through a lateral wall (28) of the sampling tube (2). One holder (11) is mounted in each seat (27). A temperature sensor (22) is mounted in the holder (11) such that a sensing part (25) of the temperature sensor (22) protrudes inside a volume (29) internally delimited by the sampling tube (2). A blocking element works in the seat (27) and is movable between a locking position, in which the blocking element locks the holder (11) in the seat (27), and a release position, in which the holder (11) is free to be extracted from the seat (27) or inserted in the seat (27).

Description

[0001] “Device for testing medicament inhalers”

[0002] DESCRIPTION

[0003] Technical field of the invention

[0004] The present invention relates to a device for testing medicament inhalers. Particularly, the present invention relates to a device for testing temperatures of plume emitted from a medicament metered dose inhaler (MDI) upon actuation of the inhaler.

[0005] Background art

[0006] Plume temperature testing equipment is used for product development of inhalers. For instance, plume temperature testing equipment is employed to measure temperatures of plume ejected from pressurized metered dose inhalers at increasing distances from the plume origin, to detect the Cold Freon Effect which causes patient discomfort and influences the efficiency of the medicament delivery. The Cold Freon Effect is the chilling sensation that the user experiences in the throat upon actuation of the inhaler due to impaction of the delivered dose and quick evaporation of any remaining propellant.

[0007] Public document - “Existing plume temperature testing equipment” by Mark Copley and David Lewis, Inhalation Magazine, December 2012 - discloses a trial test apparatus comprising a propylene sampling tube with four centrally aligned thermocouples mounted vertically at a distance of 25, 50, 75, 100 mm from the inlet. Public document - “Driving Results in Inhaler Testing” by Copley Scientific AG, Edition 2020 - discloses (page 112) the plume Temperature Tester Model PTT 1000 comprising a polypropylene sampling tube with four centrally aligned thermocouples mounted vertically 25, 50, 75, 100 mm from the inlet and linked to a data acquisition system under the control of a PC.

[0008] Public document - “Plume temperature emitted from metered dose inhalers” by G. Brambilla, T. Church, D. Lewis, B. Meakin, International Journal of Pharmaceutics 405 (2011 ) 9-15 - discloses a sampling tube of polyethylene terephthalate provided with an upper, a middle and a lower thermocouple mounted 20 mm from the inlet of the apparatus. Summary

[0009] The Applicant realized that the plume testing equipment of the prior art may be improved to ease the operation by the users and to improve the quality and accuracy of the measurements.

[0010] The Applicant noted that the thermocouples disclosed in the documents cited above are wedged in seats fashioned in the respective tube (e.g. “Plume temperature emitted from metered dose inhalers”) or are screwed in holders lodged in seats made in the respective tube (e.g. “Driving Results in Inhaler Testing”).

[0011] The Applicant realized that these kind of fastening means do not allow the user to easily mount, dismount and handle the thermocouples.

[0012] The Applicant also realized that these kind of fastening means do not allow the placement of the thermocouples in the desired orientation, particularly once they have been removed and reinstalled in the tube.

[0013] It is an object of the present invention to eliminate the above drawbacks of hitherto known plume testing equipment.

[0014] It is an object of the present invention to provide a device for testing medicament inhalers capable of improving the ease of use.

[0015] It is another object of the present invention to provide a device for testing medicament inhalers allowing improvement of the speed of assembly and disassembly of the thermocouples.

[0016] It is also an object of the present invention to provide a device for testing medicament inhalers capable of increasing the accuracy of positioning the thermocouples.

[0017] It is also an object of the present invention to improve the accuracy of the measurements made through said thermocouples.

[0018] At least one of the above objects is substantially achieved by a device for testing medicament inhalers according to one or more of the appended claims and / or of the following aspects.

[0019] In accordance with an independent aspect, a device for testing medicament inhalers, comprises: a sampling tube having an inlet configured to be connected to a mouthpiece of a medicament inhaler, an outlet opposite the inlet and at least one seat made through a lateral wall of the sampling tube; at least one holder mounted in the seat; at least one temperature sensor mounted in the holder such that a sensing part of the temperature sensor protrudes inside a volume internally delimited by the sampling tube; the temperature sensor being connected to a data acquisition unit; at least one blocking element working in the seat and movable between a locking position, in which the blocking element locks the holder in the seat, and a release position, in which the holder is free to be extracted from the seat or inserted in the seat.

[0020] The volume delimited by the sampling tube stands as a schematic representation of the patient’s throat.

[0021] In the locking position, the holder is locked in the seat such that said holder and the temperature sensor do not move unintentionally, for instance by moving the sampling tube.

[0022] The Applicant verified that the blocking element allows the temperature sensor housed in the sensor holder to be mounted and dismounted on and from the tube easily, quickly and accurately. Since it is not necessary to screw or unscrew the holders, as is the case for the known devices, but simply pull them out or insert them axially, the cables connecting the sensors to the data acquisition unit are no longer in hindrance and there is no risk of them getting twisted. Cleaning of the temperature sensors during and after the analysis is also facilitated.

[0023] Further aspects of the invention are described in the following.

[0024] In an aspect, the holder is configured to be locked by the blocking element in a plurality of discrete angular positions in the seat.

[0025] The Applicant verified that this makes it possible to guarantee a certain angular position of the sensing part of the temperature sensor about its main axis. The holder not only facilitates the assembling of the temperature sensor within the sampling tube, reducing the risk of breaking the probe exposed junction, but also provides reliable, replicable and accurate positioning of the sensing part in the desired location within the sampling tube. This way, each junction may be exposed in the same way to the emitted plume.

[0026] In an aspect, when the blocking element is in the release position, the holder is free to be extracted from the seat or inserted in the seat by translation along a main axis of the sensing part.

[0027] In an aspect, the blocking element is a snap-coupling (or click-in) and a transition between the locking position and the release position is achieved by pushing or pulling the holder. The Applicant verified that the user has simply to push the holder in the seat to install the temperature sensor on the tube or to pull the holder out of the seat to remove the temperature sensor from the tube.

[0028] In an aspect, the blocking element comprises a plunger placed in a housing fashioned in the lateral wall.

[0029] In an aspect, the housing opens into the seat such that the plunger protrudes into the seat at least in the locking position.

[0030] In an aspect, the plunger is engageable in at least one recess fashioned on an outer face of the holder.

[0031] In an aspect, the at least one recess comprises a plurality of recesses distributed around the holder.

[0032] In an aspect, the recesses are from two to ten in number.

[0033] In an aspect, the plunger is engageable in one of the plurality of recesses at a time as a function of an angular position of the holder in the seat.

[0034] In an aspect, the outer face of the holder is a cylinder.

[0035] In an aspect, the holder can be fully rotated 360°.

[0036] In an aspect, the recesses are angularly equidistant one from the other.

[0037] In an aspect, each recess has a circular outline.

[0038] In an aspect, the plunger moves in the housing along a direction perpendicular to the outer face of the holder.

[0039] In an aspect, the plunger is a ball.

[0040] In an aspect, the blocking element comprises a spring configured to push the plunger towards the seat and into the recesses.

[0041] In an aspect, the spring is a coil spring.

[0042] In an aspect, the spring pushes the plunger along the direction perpendicular to the outer face of the holder.

[0043] In an aspect, the blocking element comprises a retainer configured to prevent the plunger from falling into said seat when no holder is present.

[0044] In an aspect, the blocking element comprises a body screwed in the housing.

[0045] In an aspect, the body delimits a cavity for the plunger.

[0046] In an aspect, the plunger protrudes from an exit of the cavity.

[0047] In an aspect, a position of the body in the housing is adjustable by screwing or unscrewing the body. In an aspect, the spring is placed in the cavity between the plunger and a bottom of said cavity.

[0048] In an aspect, the retainer is positioned at the exit of the cavity.

[0049] In an aspect, the retainer is shaped on an edge of the exit as a narrowing of the cavity.

[0050] In an aspect, the housing is a through hole in the lateral wall.

[0051] In an aspect, the housing opens through an opening on a lateral face of the sampling tube.

[0052] In an aspect, the body has a maneuvering end accessible through the opening to allow a user to screw or unscrew the body.

[0053] In an aspect, the holder is brought in the release position by manually pulling the holder partially out of the seat until overcoming the force of the spring and making the plunger exit the recess and / or by unscrewing the body and moving away the body and the plunger from the recess. In the release position, the holder is free to be extracted from the seat by translation along the axis.

[0054] In an aspect, the holder delimits a through passage for the temperature sensor.

[0055] In an aspect, the holder comprises a fastener operating in the through passage and configured to removably fix the temperature sensor in the holder.

[0056] In an aspect, the fastener is configured to prevent axial and rotational dislodgment of the temperature sensor.

[0057] In an aspect, the fastener comprises a dowel.

[0058] In an aspect, the dowel is screwed through a hollow in the holder and protrudes into the through passage.

[0059] In an aspect, the hollow in the holder opens, through a window, on an external face of said holder.

[0060] In an aspect, the dowel has a maneuvering extremity accessible through the window to allow a user to screw or unscrew the dowel.

[0061] In an aspect, the through passage of the holder comprises a parallelepipedal seat configured to house a connector of the temperature sensor. The external shape of the connector and the conjugate shape of the parallelepipedal seat allow different placements of the temperature sensor inside the holder.

[0062] In an aspect, the through passage of the holder comprises an elongated channel configured to partly house a rod of the temperature sensor carrying the sensing part. In an aspect, the sensing part is at an extremity of the rod. In an aspect, the through passage of the holder comprises a junction channel between the parallelepipedal seat and the elongated channel, wherein the dowel in the hollow protrudes into the junction channel.

[0063] In an aspect, the parallelepipedal seat is connected to the elongated channel through at least one converging section; optionally, the parallelepipedal seat is connected to the junction channel through a first converging section; optionally, the junction channel is connected to the elongated channel through a second converging section. These converging sections simplify the removal and reconnection of the temperature sensors and avoid damaging the sensing parts. This improvement is also believed to allow a more frequent, easier, and more accurate cleaning process of the sensing parts.

[0064] In an aspect, the sensing part protrudes from the elongated channel.

[0065] In an aspect, temperature sensors with different rod lengths are available, to allow measurements from the central axis or near an inner surface of the sampling tube.

[0066] In an aspect, the holder comprises a parallelepipedal body delimiting internally the parallelepipedal seat, a cylindrical body and a tip protruding from the cylindrical body.

[0067] In an aspect, the seat made through the lateral wall of the sampling tube presents a conjugate shape to that of the holder.

[0068] In an aspect, the cylindrical body and the tip delimit internally the elongated channel.

[0069] In an aspect, the hollow is made through the cylindrical body.

[0070] In an aspect, holders having cylindrical bodies of different lengths are available to allow placement of the sensing parts of the temperature sensors within the sampling tube at different depths. This solution makes the use of cylindrical sheaths, protruding from the tip to partially cover and protect the rod, unnecessary and little disrupts the plume flow. Indeed, the rod is protected by the cylindrical body.

[0071] In an aspect, the seat comprises a large cylindrical portion opening outwards on the lateral face of the sampling tube and configured for housing the cylindrical body of the holder.

[0072] In an aspect, the seat comprises a small cylindrical portion opening inwards in the volume internally delimited by the sampling tube and configured to house the tip of the holder.

[0073] In an aspect, when the holder is properly mounted in the seat, an end face of the tip is flush with an inner surface of the sampling tube. In an aspect, an annular seal is mounted around the tip.

[0074] In an aspect, the holder comprises a cylindrical sheath protruding from the tip to partially cover and protect the rod.

[0075] In an aspect, the temperature sensor is a thermocouple.

[0076] In an aspect, the sensing part of the temperature sensor is a junction of electrical conductors of the thermocouple.

[0077] In an aspect, the junction is at an extremity of the rod.

[0078] In an aspect, the thermocouple is type K.

[0079] In an aspect, a temperature range of the thermocouple for short term exposures goes from -180 °C to 800 °C.

[0080] In an aspect, the device for testing medicament inhalers comprises a plurality of said holders and a plurality of temperature sensors each mounted in one holder.

[0081] In an aspect, the sensing parts of the temperature sensors are aligned along an axial path parallel to a central axis of the sampling tube.

[0082] In an aspect, the sensing parts of the temperature sensors are spaced one from the other of a same length interval.

[0083] In an aspect, said length interval is between 20 mm and 30 mm, optionally of 25 mm.

[0084] In an aspect, the sensing part of the temperature sensor or of each temperature sensor is oriented along a radial directions of the tube.

[0085] In an aspect, the device for testing medicament inhalers comprises a device for generating a directional airflow stream through the sampling tube, to simulate a flow used to perform delivered dose analysis, as per European Pharmacopoeia instructions. The device for generating the directional airflow stream is connected to the outlet of the sampling tube.

[0086] In an aspect, the device for testing medicament inhalers comprises a Dosage Unit Sampling Apparatus (DUSA) connected to the outlet of the sampling tube.

[0087] In an aspect, the device for testing medicament inhalers comprises a pump connected to the Dosage Unit Sampling Apparatus.

[0088] In an aspect, the device for testing medicament inhalers comprises a mouthpiece adaptor configured to connect the inlet of the sampling tube to the mouth of the medicament inhaler.

[0089] In an aspect, the device for testing medicament inhalers comprises a computer connected to the data acquisition unit or the data acquisition unit of the device for testing medicament inhalers is configured to be connected to a computer. A program running on the computer is configured to perform temperatures analysis and optionally delivered dose analysis.

[0090] In an aspect, the program is configured to detect the Cold Freon Effect which causes patient discomfort and influences the efficiency of the medicament delivery.

[0091] In accordance with an aspect, a method for mounting a temperature sensor in the device for testing medicament inhalers disclosed above, comprises: inserting the temperature sensor in the through passage of the holder and fixing the temperature sensor in the holder through the fastener; pushing the holder with the temperature sensor into the seat until the plunger engages one of the recesses of the holder.

[0092] In accordance with an aspect, a method for dismantling a temperature sensor in the device for testing medicament inhalers disclosed above, comprises: pulling the holder until disengaging the plunger from the recess and extracting the holder from the seat.

[0093] In accordance with another aspect, the method for dismantling comprises: removing the temperature sensor from the holder before or after extracting the holder from the seat.

[0094] Further features and advantages will be clearer from the detailed description of a preferred but not exclusive embodiment of a device for testing medicament inhalers according to the present invention.

[0095] Description of the drawings

[0096] Figure 1 shows a device for testing medicament inhalers according to the invention; Figure 2 shows a holder and a temperature sensor employed in the device of figure 1 ;

[0097] Figure 3 shows a longitudinal cross section of the holder and temperature sensor of figure 2;

[0098] Figure 4 is a 3D view of the holder of figures 2 and 3;

[0099] Figure 5 shows a longitudinal cross section of the holder of figure 4;

[0100] Figure 6 is a cross section of a part of a sampling tube with the holder and temperature sensor of the device of figure 1 ;

[0101] Figure 7 is a 3D view of a variant embodiment of the holder of figures 2 to 6;

[0102] Figure 8 is a longitudinal cross section of the holder of figure 7;

[0103] Figure 9 is a 3D view of another embodiment of the holder of figures 2 to 6; Figure 10 is a longitudinal cross section of the holder of figure 9.

[0104] Detailed description

[0105] With reference to the appended drawings, Figure 1 shows a device for testing medicament inhalers according to the present invention.

[0106] The device 1 comprises a sampling tube 2 having an inlet 3 connected to a mouth of a medicament inhaler 4 (pMDI in figure 1 ) and an outlet 5 opposite the inlet 3. Mouthpiece adaptors, like the one 2A shown in figure 1 , may be employed to connect the inlet 3 of the sampling tube 2 to the mouth of different medicament inhalers 4. The sampling tube 2 has a straight central axis “X-X”. Inlet 3 and outlet 5 are aligned along said straight central axis “X-X”.

[0107] The outlet 5 of the sampling tube 2 is connected to a Dosage Unit Sampling Apparatus (DUSA) 6. The Dosage Unit Sampling Apparatus 6 may be per se known and is not detailed here. A DUSA is used to perform those tests specified in the Pharmacopoeias relating to “delivered” or “emitted” dose. One end of the DUSA 6 is connected to the outlet 5 of the sampling tube 2, an opposite end of the DUSA 6 is connected to a pump 7. The pump 7 is configured to generate a directional airflow stream through the sampling tube 3 and through the Dosage Unit Sampling Apparatus 6, to simulate a flow used to perform delivered dose analysis, as per European Pharmacopoeia instructions.

[0108] The device 1 comprises four temperature assemblies 8 aligned one to the other along an axial path parallel to the central axis “X-X” of the sampling tube 2. The temperature assemblies 8 are connected to a data acquisition unit 9 connected to a computer 10, for instance a PC, configured to perform temperatures analysis.

[0109] The temperature assemblies 8 are identical. Therefore, only one will be outlined in the following.

[0110] The temperature assembly 8 comprises a holder 11 made for instance of molded plastic, e.g. polypropylene. The holder 11 shown in the attached figures is made of a single piece of molded plastic and comprises a parallelepipedal body 12, a cylindrical body 13 and a tip 14 protruding from the cylindrical body 13.

[0111] The holder 11 delimits internally a through passage extending along an axis “Y-Y”. The through passage comprises (figure 5) a parallelepipedal seat 15 delimited in the parallelepipedal body 12 and opening on a proximal end of the holder 11 , an elongated channel 16 opening on a distal end of the tip 14 and a junction channel 17 placed between and connecting the parallelepipedal seat 15 and the elongated channel 16. The parallelepipedal seat 15 is connected to the junction channel 17 through a first converging section which tapers from the parallelepipedal seat 15 towards the junction channel 17. The junction channel 17 is connected to the elongated channel 16 through a second converging section which tapers from the junction channel 17 towards the elongated channel 16.

[0112] A hollow 18 is fashioned in the cylindrical body 13. The hollow 13 opens inside the junction channel 17 and outside, through a window, on an external face of the cylindrical body 13. The hollow 18 is internally threaded and a dowel 19 is screwed in the hollow 18. The dowel 19 has a maneuvering extremity accessible through the window to allow a user to screw or unscrew the dowel 19. The dowel 19 can be screwed in as far as it will protrude in the junction channel 17.

[0113] An annular seal 20 is mounted in an annular groove around the tip 14.

[0114] Furthermore, a plurality of recesses 21 are distributed on an outer face of the cylindrical body 13 and around the axis “Y-Y”. Each recess 21 is defined by a depression having a circular outline. In the example embodiment of the attached figures, the recesses 21 are eight in number and are angularly spaced one from the other of 45°.

[0115] The temperature assembly 8 comprises a temperature sensor 22 which may be a thermocouple of a kind per se known, for instance of K-type. The thermocouple comprises a male connector 23, a rod 24 and a sensing part 25 carried at an extremity of the rod 24. The rod 24 is connected to the connector 23 through a sleeve 26. The sensing part 25 is a junction of electrical conductors of the thermocouple. A temperature range of the thermocouple for short term exposures goes from -180 °C to 800 °C. The rod 24 and the sensing part 25 are aligned along a main axis of the rod 24.

[0116] In figure 1 , the sensing parts 25 of the four thermocouples, not visible, are aligned along an axial path parallel to the central axis “X-X” of the sampling tube 2 and spaced one from the other of a same length interval of about 25 mm.

[0117] Each thermocouple is connected to the data acquisition unit 9 to provide signals to said data acquisition unit 9 indicative of a temperature detected inside the sampling tube 2.

[0118] When the thermocouple is housed in the through passage of the holder 11 , like in figures 2, 3, 6, the connector 23 is housed in the parallelepipedal seat 15, the sleeve 26 is housed in the junction channel 17, the rod 24 is partly housed in the elongated channel 16 and protrudes from the tip 14. Since the cross section of the parallelepipedal seat 15 is rectangular, the external shape of the connector 23 of the attached figures and the conjugate shape of the parallelepipedal seat 15 allow two different placements of the thermocouple inside the holder 11. The thermocouple is fastened in the holder 11 through the dowel 19 which is screwed to protrude in the junction channel 17 and to clamp the sleeve 26. The main axis of the rod 24 matches with the axis “Y-Y” (figure 6).

[0119] The temperature assembly 8 is mounted in a seat 27 made through a lateral wall 28 of the sampling tube 2 (figure 6). The seat 27 presents a conjugate shape to that of the cylindrical body 13 and of the tip 14 of the holder 11 . The seat 27 comprises a large cylindrical portion opening outwards on the lateral face of the sampling tube 2 and configured for housing part of the cylindrical body 13 of the holder 11 and a small cylindrical portion opening inwards in a volume 29 internally delimited by the sampling tube 2 and configured to house the tip 14 of the holder 11 .

[0120] When the holder 11 is properly mounted in the seat, an end face of the tip 14 is flush with an inner surface of the sampling tube 2, like in figure 6, and the rod 24 of the thermocouple provided with the sensing part 25 protrudes inside the volume 29 along a radial direction referred to the sampling tube 2. The radial direction of the sampling tube 2 matches with the main axis of the rod 24 and with the axis “Y-Y” (figure 6).

[0121] A housing 30 is fashioned like a through hole in the lateral wall 28 of the sampling tube 2 and opens into the seat 27 and, through an opening, on a lateral face of the sampling tube 2. The housing 30 extends along an axis perpendicular to the axis “Y-Y” of the through passage of the holder 11 .

[0122] A body 31 is screwed in the housing 30 and its position is adjustable by screwing or unscrewing said body 31 through its maneuvering end accessible through the opening. The body 31 delimits a cavity 32 for a coil spring 33 and a plunger 34 shaped like a ball. The spring 33 is placed in the cavity 32 between the plunger 34 and a bottom of said cavity 32. An exit of the cavity 32 is opposite to the bottom and faces the seat 27. The spring 33 pushes the plunger 34 along a direction perpendicular to the axis “Y-Y” and towards the exit, such that the plunger 34 partly protrudes from the exit of the cavity 32 and into the seat 27. An edge of the exit, shaped as a narrowing of the cavity 32, prevents the plunger 34 from falling into the seat 27 when no holder 11 is present.

[0123] When the holder 11 is in the seat 27, the recesses 21 are positioned at a same height as the exit and the plunger 34, such that the spring 33 can push the plunger 34 into one of the recesses 21 in a locking position, eventually after little rotating the holder 11 in the seat 27 about the axis “Y-Y”. In the locking position, the plunger 34 locks the holder 11 in the seat 27 such that the holder 11 and the thermocouple do not move unintentionally, for instance by moving the sampling tube 2.

[0124] The holder 11 can be brought in a release position by manually pulling the holder 11 partially out of the seat 27 along the axis “Y-Y” until overcoming the force of the spring 33 and making the plunger 34 exit the recess 21 and / or by unscrewing the body 31 and moving away the body 31 and the plunger 34 from the recess 21. In the release position, the holder 11 is free to be extracted from the seat 27 by translation along the axis “Y-Y”.

[0125] The thermocouple may also be removed from the holder 11 after unscrewing the dowel 19 and before or after extracting the holder 11 from the seat 27.

[0126] To install again the holder 11 and the thermocouple on the sampling tube 2, the user has to push the holder 11 in the seat 27 along the axis “Y-Y” and to little rotate the holder 11 until the plunger 34 is again pushed in one of the recesses 21 by the spring 33 (snap-coupling or click-in). Furthermore, the body 31 may also be screwed to better lock the holder 11 .

[0127] The holder 11 can also be manually rotated about the axis “Y-Y” to dislodge the plunger 34 from one recess 21 , by overcoming the force of the spring 33, and then letting the plunger 34 entering a different recess 21 . Therefore, the holder 11 can be locked in the seat 27 in a plurality of discrete angular positions spanning 360°, each corresponding to one recess 21 . The angular position of the holder 11 can also be adjusted without removing the holder 11 from the sampling tube 2.

[0128] The variant embodiment of figures 7 and 8 differs from the one detailed above in a cylindrical sheath 35 protruding from the tip 14 and partially covering and protecting the rod 24. Only the sensing part 25 remains outside the cylindrical sheath 35.

[0129] The variant embodiment of figures 9 and 10 differs from the embodiment of figures 2 and 3 for the longer cylindrical body 13, which, once inserted in the seat 27, allow placement of the sensing part 25 of the thermocouple within the sampling tube 2 at different depths, to allow measurements from the central axis or near an inner surface of the sampling tube 2. However, also thermocouples having different rod lengths are available.

[0130] List of parts

[0131] 1 device for testing medicament inhalers

[0132] 2 sampling tube

[0133] 2A mouthpiece adaptor

[0134] 3 inlet

[0135] 4 pressurized Metered Dose Inhaler (pMDI)

[0136] 5 outlet

[0137] 6 Dosage Unit Sampling Apparatus

[0138] 7 pump

[0139] 8 temperature assembly

[0140] 9 data acquisition unit

[0141] 10 computer

[0142] 11 holder

[0143] 12 parallelepipedal body

[0144] 13 cylindrical body

[0145] 14 tip

[0146] 15 parallelepipedal seat

[0147] 16 elongated channel

[0148] 17 junction channel

[0149] 18 hollow

[0150] 19 dowel

[0151] 20 annular seal

[0152] 21 recesses

[0153] 22 temperature sensor, thermocouple

[0154] 23 connector

[0155] 24 rod

[0156] 25 sensing part

[0157] 26 sleeve

[0158] 27 seat

[0159] 28 lateral wall

[0160] 29 volume 30 housing

[0161] 31 body

[0162] 32 cavity

[0163] 33 spring 34 plunger

[0164] 35 cylindrical sheath

[0165] X-X central axis

[0166] Y-Y axis

Claims

CLAIMS1 . A device for testing medicament inhalers, comprising: a sampling tube (2) having an inlet (3) configured to be connected to a mouth of a medicament inhaler (4), an outlet (5) opposite the inlet (3) and at least one seat (27) made through a lateral wall (28) of the sampling tube (2); at least one holder (11 ) mounted in the seat (27); at least one temperature sensor (22) mounted in the holder (11 ) such that a sensing part (25) of the temperature sensor (22) protrudes inside a volume (29) internally delimited by the sampling tube (2); the temperature sensor (22) being connected to a data acquisition unit (9); at least one blocking element working in the seat (27) and movable between a locking position, in which the blocking element locks the holder (11 ) in the seat (27), and a release position, in which the holder (11 ) is free to be extracted from the seat (27) or inserted in the seat (27).

2. The device according to claim 1 , wherein the holder (11 ) is configured to be locked by the blocking element in a plurality of discrete angular positions in the seat (27).

3. The device according to claim 1 or 2, wherein, when the blocking element is in the release position, the holder (11 ) is free to be extracted from the seat (27) or inserted in the seat (27) by translation along a main axis of the sensing part (25).

4. The device according to any of claims 1 to 3, wherein the blocking element is a snap-coupling and a transition between the locking position and the release position is achieved by pushing or pulling the holder (11 ).

5. The device according to any of claims 1 to 4, wherein the blocking element comprises a plunger (34) placed in a housing (30) fashioned in the lateral wall (28); wherein the housing (30) opens into the seat (27) such that the plunger (34) protrudes into the seat (27) at least in the locking position; wherein the plunger (34) is engageable in at least one recess (21 ) fashioned on an outer face of the holder6. The device according to claim 5, wherein the at least one recess (21 ) comprises a plurality of recesses (21 ) distributed around the holder (11 ); the plunger (34) being engageable in one of the plurality of recesses (21 ) at a time as a function of an angular position of the holder (11 ) in the seat (27).

7. The device according to claim 5 or 6, wherein the blocking element comprises: a spring (33) configured to push the plunger (34) towards the seat (27) and into the recesses (21 ); a retainer configured to prevent the plunger (34) from falling into said seat (27) when no holder (11 ) is present.

8. The device according to any of claims 5 to 7, wherein the blocking element comprises a body (31 ) screwed in the housing (30), the body (31 ) delimiting a cavity (32) for the plunger (34); wherein the plunger (34) protrudes from an exit of the cavity (32); wherein a position of the body (31 ) in the housing (30) is adjustable by screwing or unscrewing the body (31 ).

9. The device according to claim 8 when depending on claim 7, wherein the spring (33) is placed in the cavity (32) between the plunger (34) and a bottom of said cavity (32); wherein the retainer is positioned at the exit of the cavity (32).

10. The device according to claim 8 or 9, wherein the housing (30) opens through an opening on a lateral face of the sampling tube (2) and the body (31 ) has a maneuvering end accessible through the opening to allow a user to screw or unscrew the body (31 ).11 . The device according to any of claims 1 to 10, wherein the holder (11 ) delimits a through passage for the temperature sensor (22) and comprises a fastener operating in the through passage and configured to removably fix the temperature sensor (22) in the holder (11 ); the fastener being configured to prevent axial and rotational dislodgment of the temperature sensor (22).

12. The device according to claim 11 , wherein the fastener comprises a dowel (19) screwed through a hollow (18) in the holder (11 ) and protruding into the through passage.

13. The device according to claim 12, wherein the hollow (18) in the holder (11 ) opens, through a window, on an external face of said holder (11 ) and the dowel (19) has a maneuvering extremity accessible through the window to allow a user to screw or unscrew the dowel (19).

14. The device according to any of claims 1 to 13, wherein the temperature sensor (22) is a thermocouple and the sensing part (25) of the temperature sensor (22) is a junction of electrical conductors of the thermocouple.

15. The device according to any of claims 1 to 14, comprising a plurality of said holders (11 ) and a plurality of temperature sensors (22) each mounted in one holder (11 ); wherein the sensing parts (25) of the temperature sensors (22) are aligned along an axial path parallel to a central axis (X-X) of the sampling tube (2).

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