Electronic inhaler and adjustment method thereof

Abstract

The present invention relates to a method for adjusting an inhaler for inhaling a liquid drug preparation, and an inhaler with a nozzle for use in the method. The method is used to adjust the inhaler. The inhaler comprises a nozzle portion having an inner cavity and a connected body portion. The body portion comprises a body having a base facing the inner cavity. The body further comprises: a nozzle having an outlet extending from the base into the inner cavity for discharging the drug preparation; a counter electrode at the base, which is at a counter electrode distance from the nozzle outlet; and a discharge electrode, which is at a discharge electrode distance from the nozzle outlet. The inhaler further comprises a power supply and an air inlet. The method comprises the step of adjusting the electrode relative to the nozzle outlet of the inhaler.

Description

Technical Field

[0001] The present invention relates to a method for regulating an inhaler for inhaling a liquid pharmaceutical preparation, the method for regulating an inhaler using an inhaler comprising:

[0002] a nozzle portion comprising a circumferential wall extending from an edge of the suction opening, said circumferential wall surrounding the inner cavity, and

[0003] - a body portion coupled to the mouthpiece portion, the body portion comprising a body having a base facing the inner cavity and defining the limit of the inner cavity of the mouthpiece portion, the body further comprising:

[0004] i) a nozzle comprising a nozzle inlet at a first end of the nozzle for receiving a liquid drug formulation and a nozzle outlet at a second end of the nozzle for expelling the drug formulation, wherein the nozzle passes through the base and a portion of the nozzle including the nozzle outlet extends into the lumen,

[0005] ii) a counter electrode arranged at the base, relatively close to the nozzle, at a counter electrode distance from the nozzle outlet, the counter electrode distance defining an electric field path,

[0006] iii) a discharge electrode, the discharge electrode comprising a discharge portion arranged relatively far from the nozzle compared to the counter electrode, the discharge portion being spaced apart from the nozzle outlet by a discharge electrode distance, wherein the discharge electrode distance is greater than the counter electrode distance;

[0007] The inhaler further comprises:

[0008] - a power source electrically connected to at least one of the nozzle, the counter electrode, and the discharge electrode, and

[0009] - an air inlet for admitting air for inhalation into the inner cavity. Background Art

[0010] Electronic inhalers are capable of aerosolizing liquid drug formulations and are well known in the art, including the production and tuning of such inhalers. The advantages of electronic inhalers over manual inhalers are manifold, particularly the relatively uniform particle size achieved by aerosolization and thus better delivery and more accurate dosing compared to mechanical or pressurized inhalers.

[0011] These electronic inhalers include a body portion with an air inlet through which an air flow can pass. The air inlet is fluidically connected to an inner cavity in the mouthpiece portion, which includes an inhalation opening disposed adjacent to the body portion. In the inner cavity, a liquid drug preparation can be atomized, and a user can inhale the atomized drug preparation carried by the air flow through the inhalation opening. The nozzle outlet at the end of the nozzle merges into the inner cavity of the mouthpiece portion and is arranged to be used for atomizing a liquid drug composition into the inner cavity. Typically, the nozzle is a thin capillary needle, which has a nozzle inlet at one end that allows the liquid drug preparation contained in the reservoir to enter the nozzle. The reservoir can be provided with an inhaler that is fluidically connected to the nozzle inlet, but the reservoir can also be provided later, for example, as a replacement charge. A pump can be provided, but it is not necessary for its function, and the capillary force generated by the nozzle or pressurized reservoir can also achieve the appropriate flow of the liquid drug preparation through the nozzle. A pump may be preferred. The nozzle also has a nozzle outlet, through which the drug preparation passes, and from which the drug preparation is atomized into the inner cavity of the mouthpiece portion. Typically, the user causes an airflow through the inner cavity by inhalation, and the airflow carries the atomized drug preparation to the target tissue of the user's respiratory system.

[0012] In order to atomize the liquid drug preparation into the inner cavity, a Taylor cone is established at the nozzle outlet by means of the potential between the nozzle and the counter electrode. This is typically a stable Taylor cone with a single jet, but it can also be a temporary Taylor cone. The Taylor cone is a typical conical liquid volume. The Taylor cone presents a tip from which the jet emerges. At a distance from the Taylor cone, the jet splits into charged liquid particles that move away from the Taylor cone, and for the purpose of inhaling the drug preparation, these particles are about 0.1 to 10 microns. The electric field strength between the counter electrode and the nozzle outlet is the main determinant of the particle size of the jet atomization. These atomized particles together constitute a spray in the air in the inner cavity of the mouth portion, and the spray can be inhaled together with the airflow caused by the user's inhalation. Importantly, the spray is discharged in large quantities and includes a relatively uniform distribution of particle sizes so as to be effectively delivered to the selected respiratory system tissue. The discharge of the particles in the spray is achieved by a discharge electrode, which has a sharp tip that acts as a discharge portion, from which corona particles with a charge opposite to the spray particles can be emitted. These corona particles collide and fuse with particles in the spray and thus cause a discharge of the spray.

[0013] A disadvantage of prior art electronic inhalers is that they are designed and manufactured accordingly for delivery of specific drug formulations to specific tissues of the respiratory system, each formulation requiring the manufacture of a different inhaler having different specifications. Summary of the invention

[0014] It is an object of the present invention to provide a method for tuning an electronic inhaler after it has been manufactured to deliver a selected drug formulation to a selected tissue of the respiratory system.

[0015] To this end, the method according to the preamble is characterized in that the method comprises the step of adjusting the discharge electrode distance.

[0016] In this way, inhalers can be manufactured cheaply, and single models are produced, and after manufacturing, inhalers can be adjusted to the required specifications for use with selected liquid pharmaceutical preparations. Therefore, only a single production line is needed to manufacture the same batch of inhalers, without the need to stop production and change parts. This can also reduce errors in the manufacturing process, wherein wrong parts may be incorporated into the inhaler during the manufacturing process. Those skilled in the art can determine that the selected liquid pharmaceutical preparation is atomized into a spray with a desired particle size and spray shape to be delivered to the required counter electrode distance of the selected tissue of the respiratory system.

[0017] Setting the nozzle outlet at an appropriate distance from the discharge electrode can produce a spray that is wide enough to ensure that the particle size remains uniform, but the spray is narrow enough to reduce the loss of the aerosolized drug formulation to the circumferential wall of the mouth portion of the inhaler, thereby improving the inhaler's delivery of the liquid drug formulation to any selected target tissue of the respiratory system.

[0018] The method may further comprise the step of adjusting the distance between the electrodes.

[0019] Setting the nozzle outlet relatively close to the counter electrode can produce a spray to improve delivery to alveolar tissue. Setting the nozzle outlet at an increased distance from the counter electrode can produce a spray to improve delivery to any tissue selected from the group consisting of alveoli, bronchioles, bronchi or trachea, respectively.

[0020] The nozzle outlet is set at a suitable distance from the counter electrode and / or the discharge electrode to deliver the atomized drug preparation to the specific tissue of the respiratory system, which is not universal for different drug preparations, even if the concentration changes and also can affect atomization. It is necessary to determine suitable settings for each different liquid drug preparation, and this determination can be performed by any technician by determining the particle size in the spray. These settings include the potential to be set up on the nozzle, the counter electrode and the discharge electrode, wherein the counter electrode is usually set to 0 volts, and further include the counter electrode distance and / or the discharge electrode distance according to the present invention, which can be set after production, and used together with the desired liquid drug preparation for fine-tuning the inhaler.

[0021] US2019209791 describes an inhaler in which the discharge electrode distance can be selected when manufacturing the inhaler to avoid electrical breakdown of the air, but does not disclose an inhaler in which the discharge electrode distance can be adjusted after manufacturing to control the width of the spray.

[0022] According to an advantageous embodiment, the inhaler further comprises a discharge electrode actuator capable of moving the nozzle and the discharge electrode relative to each other; and

[0023] Therein, in the method, the step of adjusting the discharge electrode distance is performed by moving the nozzle and the discharge electrode relative to each other.

[0024] In this way, more precise adjustment is possible. The inhaler can be adjusted and, if it is detected that the adjustment does not meet the appropriate settings for delivering the selected liquid drug formulation to the selected tissue of the respiratory system, can be readjusted. The discharge of the spray adjusts the size and thus the efficiency of delivery to the target tissue, if the spray is too large for the mouthpiece portion, part of it will be lost on the inner surface of its circumferential wall.

[0025] According to an advantageous embodiment, the inhaler further comprises discharge electrode fixing means for fixing the nozzle in a suitable position relative to the discharge electrode; and

[0026] The method further comprises the step of fixing the nozzle in position relative to the discharge electrode.

[0027] In this way, the method provides an inhaler with consistent performance.Finally, after adjusting the part of the nozzle extending into the inner cavity, the discharge electrode distance can be firmly fixed at the desired distance, thereby providing the inhaler that maintains the desired characteristics and is not prone to accidentally readjusting or tampering with.Therefore, the method can further be included in the step of adjusting or readjusting the discharge electrode distance, and the nozzle is fixed in the step in the appropriate position relative to the discharge electrode.Preferably, the discharge electrode fixture can only be operated by the personnel who obtain the inhaler market authorization, and therefore its function meets the requirements and keeps meeting the requirements.

[0028] According to an advantageous embodiment, the step of adjusting the distance to the electrodes is performed by cutting off the portion of the nozzle extending into the lumen.

[0029] In this way, the relatively long part of the nozzle can be modified cheaply, and the discharge electrode distance is reduced, without the need for adjusting the adjustment device of the part extending into the inner cavity of the nozzle. This allows the manufacture of a very cheap inhaler, which can be modified as needed after production. The cut-off nozzle portion removes the old nozzle outlet and creates a new nozzle outlet at the desired electrode distance from the counter electrode. Those skilled in the art can use their common sense to determine that the part extending into the inner cavity should be cut off to obtain the length of the desired characteristics. Once determined, this step can be performed on all inhalers for the same liquid drug preparation to be targeted to the same tissue.

[0030] According to an advantageous embodiment, the inhaler further comprises a counter electrode actuator capable of moving the nozzle and the counter electrode relative to each other; and

[0031] Therein, in the method, the step of adjusting the distance to the counter electrode is performed by moving the nozzle and the counter electrode relative to each other.

[0032] In this way, more precise adjustment is possible.The inhaler may be adjusted and readjusted if it is detected that the adjustment does not correspond to the appropriate setting for delivering the selected liquid drug formulation to the selected tissue of the respiratory system.

[0033] According to an advantageous embodiment, the inhaler further comprises counter electrode fixing means for fixing the nozzle in a suitable position relative to the counter electrode; and

[0034] The method further comprises the step of fixing the nozzle in position relative to the counter electrode.

[0035] In this way, the method provides an inhaler with consistent performance.Finally, after adjusting the part extending into the inner cavity of the nozzle, the electrode distance can be firmly fixed at the desired distance, thereby providing the inhaler that maintains the desired characteristics and is not prone to accidentally readjusting or tampering with.Therefore, the method can further be included in after adjusting or readjusting the step of the electrode distance, the nozzle is fixed in the step in the proper position relative to the electrode.Preferably, the electrode fixture can only be operated by the personnel who obtain the inhaler market authorization, and therefore its function meets the requirements and keeps meeting the requirements.

[0036] According to an advantageous embodiment, the mouthpiece of the inhaler is a removable mouthpiece; and

[0037] Therein, in the method, the step of adjusting the distance of the counter electrodes is performed by replacing the removable nozzle with a replacement nozzle that is shorter or longer than the removable nozzle or has the same size as the removable nozzle.

[0038] In this way, by simply replacing the removable nozzle with the replacement nozzle, the inhaler produced that is suitable for a purpose can be converted into the inhaler that is suitable for sending different liquid drug preparations and / or the different tissues of the target respiratory system, and the replacement nozzle comprises a part that extends to the inner chamber farther or closer than the removable nozzle after insertion.Therefore, for example, the manufacturer can quickly respond to the change of market demand by converting the inhaler quickly and cheaply.After using for a long time, due to the accumulation of the composition of dirt or liquid drug preparation at the nozzle or in the nozzle or at the nozzle outlet, or due to the wear and tear of the nozzle or nozzle coating, when function may change, the inhaler also can be renovated in this way with the same replacement nozzle.Therefore, renovating the inhaler with the clean and unused replacement nozzle of same size allows the inhaler to be adjusted to the original desired setting.

[0039] According to an advantageous embodiment, the nozzle preferably comprises a marking at the portion of the nozzle extending into the lumen; and

[0040] During the step of adjusting the distance between the electrodes, the markings are used to guide the adjustment.

[0041] In this way, visual inspection allows to check the correct assembly and setting of inhaler. The nozzle allows to easily adjust by the position of visual inspection mark or cutting at the mark. Visual inspection mark can also indicate the nozzle does not correctly engage with the nozzle division with respect to the base (the electrode is arranged at this base), thereby causing bad or incorrect function. For example, mark can indicate the nozzle outlet distance or the distance to the base. Mark can include etching or carving on the nozzle or apply mark or the coating with mark on the nozzle.

[0042] The present invention also relates to an inhaler for inhaling a liquid pharmaceutical preparation, the inhaler comprising:

[0043] a nozzle portion comprising a circumferential wall extending from an edge of the suction opening, said circumferential wall surrounding the inner cavity, and

[0044] - a body portion coupled to the mouthpiece portion, the body portion comprising a body having a base facing the inner cavity and defining the limit of the inner cavity of the mouthpiece portion, the body further comprising:

[0045] i) a nozzle comprising a nozzle inlet at a first end of the nozzle for receiving a liquid drug formulation and a nozzle outlet at a second end of the nozzle for expelling the drug formulation, wherein the nozzle passes through the base and a portion of the nozzle including the nozzle outlet extends into the lumen,

[0046] ii) a counter electrode arranged at the base, relatively close to the nozzle, at a counter electrode distance from the nozzle outlet, the counter electrode distance defining an electric field path,

[0047] iii) a discharge electrode, the discharge electrode comprising a discharge portion arranged relatively far from the nozzle, the discharge portion being spaced apart from the nozzle outlet by a discharge electrode distance, wherein the discharge electrode distance is greater than the counter electrode distance;

[0048] The inhaler further comprises:

[0049] - a power source electrically connected to at least one of the nozzle, the counter electrode, and the discharge electrode, and

[0050] - an air inlet for admitting air for inhalation into the inner cavity.

[0051] It is an object of the present invention to provide an inhaler which is adjustable after manufacture to improve the delivery of selected liquid drug formulations to selected tissues of the respiratory system.

[0052] For this purpose, the discharge electrode distance is adjustable.

[0053] In this way, a cheap inhaler is provided and can be adjusted to the required specifications for use with a selected liquid pharmaceutical preparation after manufacture. The inhaler can be adjusted by authorized or qualified skilled personnel. The adjustment of the inhaler according to the present invention can be performed immediately at the manufacturing site after manufacture, or can be performed later by, for example, a supplier, a general practitioner or a pharmacist who obtains market authorization to ensure appropriate dosing and targeting of the liquid pharmaceutical preparation to the selected tissue of the respiratory system.

[0054] According to an advantageous embodiment, the discharge electrode comprises a plurality of discharge portions, preferably at least 3, more preferably at least 4, even more preferably at least 6, which are at equal discharge electrode distances from the nozzle outlet and are evenly distributed around the longitudinal axis of the portion of the nozzle extending into the inner cavity.

[0055] In this way, the discharge of the spray will be more uniform.

[0056] According to an advantageous embodiment, the nozzle and the discharge electrode are movable relative to each other in the direction of the longitudinal axis of the portion of the nozzle extending into the inner cavity.

[0057] In this way, the discharge electrode distance can be adjusted along a single axis with less concern for the three-dimensional arrangement of the nozzle, counter electrode and discharge electrode, thereby making adjustment easier.

[0058] According to an advantageous embodiment, the discharge part is located outside the inner cavity.

[0059] In this way, interference of the discharge electrode with Taylor cone, jet and / or spray formation is reduced, and the delivery efficiency of the drug formulation can be improved.

[0060] According to an advantageous embodiment, the distal end of the discharge portion is directed towards the longitudinal axis of the portion of the nozzle extending into the lumen.

[0061] In this way, the discharge of the spray can be improved. Since the corona discharge particles move away from the distal end in the direction in which the distal end is pointing, it is preferred to point the distal end toward the volume of the lumen associated with the nozzle outlet, in which the jet and spray will be formed. Preferably, the angle between the distal end and the base is between 25° and 85°, more preferably between 30° and 80°, even more preferably between 35° and 75°.

[0062] According to an advantageous embodiment, the nozzle preferably comprises markings at the portion of the nozzle extending into the lumen.

[0063] In this way, visual inspection allows to check the correct assembly and setting of inhaler. The nozzle allows to easily adjust by the position of visual inspection mark or cutting at the mark. Visual inspection mark can also indicate the nozzle does not correctly engage with the nozzle division with respect to the base (the electrode is arranged at this base), thereby causing bad or incorrect function. For example, mark can indicate the nozzle outlet distance or the distance to the base. Mark can include etching or carving on the nozzle or the applied mark on the nozzle or the coating with mark.

[0064] According to an advantageous embodiment, the counter-electrode distance is adjustable.

[0065] In this way, a single model of inhaler can be adjusted for use with different liquid drug preparations. The spray characteristics (e.g., spray volume, spray shape, spray average particle charge) depend on the characteristics of the liquid drug preparation to be atomized. Therefore, the adjustability of the distance to the electrodes allows one model to be produced and used for different liquid drug preparations, thereby achieving cheaper production.

[0066] According to an advantageous embodiment, the inhaler further comprises a counter electrode actuator capable of moving the nozzle and the counter electrode relative to each other.

[0067] In this way, the setting of the electrode distance can be controlled without touching the nozzle. Touching the nozzle may affect its characteristics due to damage or dirt deposits on its surface. For example, a rack and pinion allows for quick adjustment. A fine adjustment screw with a worm can provide an enhanced adjustable precision depending on the pitch of the fine adjustment screw.

[0068] According to an advantageous embodiment, the nozzle and the counter electrode are movable relative to each other in the direction of the longitudinal axis of the portion of the nozzle extending into the lumen.

[0069] In this way, the counter electrode distance is adjustable with a substantially linear response relative to the electric field established between the nozzle outlet and the counter electrode, so that it becomes easier to set up the electronic inhaler for use with a selected liquid medicament for delivery to a selected tissue of the respiratory system. When adjusting along a single axis, the three-dimensional configuration of the nozzle and counter electrode is less of a concern.

[0070] In this way, the discharge electrode distance can be adjusted along a single axis with less concern for the three-dimensional arrangement of the nozzle, counter electrode and discharge electrode, thereby making adjustment easier.

[0071] According to an advantageous embodiment, the nozzle outlet coincides with a cone base perpendicular to the longitudinal axis of the portion of the nozzle extending into the lumen, and the side of said cone base facing the nozzle also faces the counter electrode.

[0072] In this way, the counter electrode is positioned so that, in use, particles from the spray do not migrate towards and deposit on the counter electrode, such wetting and contamination of the counter electrode by the drug formulation may interfere with the electric field and result in suboptimal delivery of the drug formulation included in the spray to the target tissue, thereby providing a lower than expected dosing in the prior art, wherein more wetting and contamination occurs over time than in an inhaler according to the present invention.

[0073] According to an advantageous embodiment, the counter electrode is annular and is arranged perpendicularly to and centered on the longitudinal axis of the portion of the nozzle extending into the lumen.

[0074] In this way, the inhaler may be able to produce a spray wherein a larger portion may be delivered to the target tissue, thereby making the inhaler more effective.

[0075] According to an advantageous embodiment, the nozzle and / or the counter electrode and / or the counter electrode actuator are configured to vary the counter electrode distance in a discrete manner.

[0076] Due to the discrete (i.e. stepwise) adjustability, preset settings are provided on the inhaler, thereby allowing, for example, manufacturers, general practitioners, pharmacists or users to adjust the inhaler easily and with reduced error, thereby providing a spray that reliably delivers the drug preparation to the expected tissue during use. A shape lock is formed at the discrete position of the nozzle or the electrode actuator, or a ratchet or beaded shape can provide discrete adjustability. This also cleverly locks the setting in the desired position.

[0077] According to an advantageous embodiment, the inhaler further comprises counter electrode fixing means for fixing the nozzle in a suitable position relative to the counter electrode.

[0078] In this way, after the inhaler has been set in the desired position, the manufacturer, general practitioner, pharmacist or user can ensure the setting of the inhaler and thus ensure reliable delivery of the drug preparation. The preset inhaler is not prone to being accidentally changed due to accidental manipulation, vibration or improper use by the user, for example.

[0079] Finally, the invention relates to the use of a mouthpiece in a method for regulating an inhaler for inhaling a liquid pharmaceutical preparation or in an inhaler for inhaling a liquid pharmaceutical preparation,

[0080] In this way, the inhaler can be adapted to market demands and / or cheaply and easily retrofitted for selected liquid drug formulations. BRIEF DESCRIPTION OF THE DRAWINGS

[0081] The present invention will now be described with reference to the accompanying drawings, in which

[0082] Figure 1A shows a cross-sectional view of an inhaler according to the invention;

[0083] Figure 1B Shown along the basis Figure 1A A cross section taken along the longitudinal axis of an embodiment of the present invention; and

[0084] Figure 2 Shown according to Figure 1A A top view of the inhaler body of an embodiment of the present invention. DETAILED DESCRIPTION

[0085] Exemplary embodiment is the inhaler 100 with tubular shape, and this inhaler comprises two parts that can be releasably connected, i.e. body part 101, and this body part is made of the first cylindrical division 101a with body part circumferential wall and open end; And mouthpiece part 102, this mouthpiece part is made of the second cylindrical division 102a that can also be releasably connected to the 3rd cylindrical division 102b, and two cylindrical divisions also have circumferential wall and open end.The body part surrounds the body part inner chamber 103, and the mouth part surrounds the mouth part inner chamber 104.Inhaler 100 has the longitudinal axis along its length, and this longitudinal axis extends through the center lines of three cylindrical divisions 101a, 102a and 102b.Inner chamber 103 and 104 form air conduit, and air can flow towards inhaler outlet 110 by this air conduit from the air inlet cover 105 of the inhaler inlet 108 that covers the body part 101, thereby allows the user to inhale airflow. Air inlet cover 105 further comprises slit 107, can pass this slit for the wiring of supplying electric power or for the pipeline of supplying liquid medicine preparation, thereby if the operation of inhaler needs more or less air flow through the air conduit of inhaler 100, then allow to remove air inlet cover 105 or replace it with different air inlet covers.The removal of air inlet cover 105 also allows to reach the adjustment device of inhaler 100, as explained later.The outlet cover 111 of closing can be assembled into the storage that is used for inhaler 100, and can be taken off before use.Inhaler outlet cover 111 prevents dust from entering the air conduit and entering the inner chamber 105 of mouthpiece part 102 by inhaler outlet 110.

[0086] Body part 101 holds inhaler body 112.Inhaler body 112 is also cylindrical in shape.The center line of inhaler body 112 is aligned along the longitudinal axis of inhaler 100.Inhaler body 112 is fastened in the inside of body part 101 by three bolts, i.e. bolt 113a, bolt 113b and bolt 113c (not shown due to sectioning), and these bolts are engaged in the matching thread in the threaded through hole in the cylindrical wall 115 of body part 101 by its thread.Bolt head 114a, bolt head 114b and bolt head 114c (not shown due to sectioning) are positioned at body part 101 outsides, thereby allow to tighten or loosen bolt 113a, 113b and 113c.Bolt length extends in the inner chamber 104 of body part 101. Bolt 113a, 113b and 113c are engaged with the outer surface of the cylindrical wall 132 of inhaler body 112 by its corresponding distal end 116a, 116b and 116c (the latter two ends are blocked by inhaler body 112 and cannot be seen), thereby holding inhaler body 112 and making it centered in the air conduit in inhaler 100. In this way, air can pass the air conduit from inhaler inlet 108 along the inhaler body 112 suspended in the center of body part inner cavity 103, and pass the mouth part inner cavity 104 subsequently, to be sucked by the user via inhaler outlet 110. When operating, airflow can include atomized pharmaceutical preparations. Figure 1B Further details of the inhaler body are discussed in .

[0087] Figure 1B Shown along the basis Figure 1A The cross section intercepted by the longitudinal axis of the embodiment of the invention. Inhaler body 112 is formed by three cylindrical shaped divisions, i.e. nozzle division 130, counter electrode division 150 and discharge electrode division 170. The center lines of each inhaler body division 130,150 and 170 are also aligned along the longitudinal axis. Nozzle division 130, counter electrode division 150 and discharge electrode division 170 can move relative to each other along the longitudinal axis of inhaler.

[0088] The nozzle division 130 is held in place by engaging the distal ends 116a, 116b and 116c of three corresponding bolts 113a, 113b and 113c with the grooves 131 arranged in the outer surface of the nozzle division cylindrical wall 132, thereby suspending the nozzle division 130 in the center of the body portion 101. The nozzle division 130 includes a capillary nozzle 133 having a nozzle inlet 134 associated with a female Luer-Lok fitting 135. The nozzle with the female Luer-Lok fitting 135 is removably positioned in a through hole passing through the center line of the nozzle division. The female Luer-Lok fitting 135 and the nozzle 133 are held in place by a retaining element 136. The retaining element 136 has a through hole through which a male Luer-Lok fitting 137 is inserted into the female Luer-Lok fitting 135. The reservoir can be directly connected to or alternatively connected to a male Luer-Lok fitting 137 by a pipeline. The through hole in the retaining element 136 acts as a snap lock on the fitting by being fitted into a groove 138 arranged on the male Luer-Lok fitting 136. This allows liquid drug preparations to enter the nozzle 133 and pass through the nozzle. At the other end of the nozzle 133 opposite to the nozzle inlet 134, a nozzle outlet 139 is provided, from which the liquid drug preparations can be atomized into a spray that can be inhaled by the user. The nozzle 133 is partially surrounded by the rigid nozzle sleeve 140 that protects the fragile nozzle, and the nozzle terminal section 141 of the nozzle 133 near the nozzle outlet 139 is not covered by the nozzle sleeve 140.

[0089] The counter electrode section 150 having a cylindrical shape and provided with a flange 151 comprises a counter electrode 152 and a nozzle shaft 153. The nozzle shaft 153 holds the nozzle sleeve 140 and allows the counter electrode section 150 to slide relative to the nozzle section 130 along the longitudinal axis. The nozzle shaft 153 presents a nozzle opening 154 at its end through which the terminal nozzle section 141 passes. The nozzle section 130 also includes a fine adjustment screw 142 that is freely rotatably engaged with the nozzle section 130, and the bolt head 143 and the nut 144 hold the fine adjustment screw worm shaft 145 in the appropriate position, thereby allowing the fine adjustment screw 142 and the worm 146 to rotate. The fine adjustment screw 142 is engaged with a threaded through hole 155 provided in the flange 151 on the counter electrode section 150. Rotation of the fine-tuning screw 142 allows the counter electrode section 150 to be moved in either direction relative to the nozzle section 130 along the longitudinal axis. The nut 144 can also be tightened to prevent the fine-tuning screw 142 from rotating, thereby effectively locking the position and therefore the distance of the nozzle outlet 139 relative to the counter electrode 152. The counter electrode section 150 also presents a base 160 having a base opening 161 and a surface facing the nozzle lumen 104. At the surface of the base, the annular counter electrode 152 is arranged to be centered on the longitudinal axis, and the nozzle 133 extends along the axis through the base opening 161 and enters the nozzle lumen 104, and its nozzle outlet 139 merges into the lumen. The annular counter electrode 152 has a width of 2 mm and is positioned so that its inner diameter is 6 mm away from the longitudinal axis. The nozzle outlet 139 extends 10 mm into the inner cavity of the second part relative to the base plane coinciding with the counter electrode 152 and the base 160, but can be adjusted within the range of 5 mm from the base plane in the direction away from the inner cavity to 25 mm from the base plane in the direction toward the inner cavity. The preferred adjustment range is 0-20 mm from the base plane in the direction toward the inner cavity, thereby reducing the wetting of the counter electrode 139.

[0090] The discharge electrode section 170 includes a counter electrode shaft 171 for accommodating the counter electrode section 150 , and is slidably disposed around the counter electrode section 150 via the shaft 171 .

[0091] The discharge electrode subdivision 170 can be moved relative to the nozzle subdivision 130 using a second fine adjustment screw, the worm shaft of which can rotate freely in the through hole of the nozzle subdivision 130 and is fixed by a nut. The worm of the fine adjustment screw extends through the through hole, thereby allowing free rotation in the flange 151 of the counter electrode subdivision 150. The worm engages with a matching threaded hole in the discharge electrode subdivision 170, thereby allowing the discharge electrode subdivision 170 to be moved relative to the nozzle subdivision 130 (not shown). In this embodiment, the discharge electrode is allowed to be adjusted 0 to 50 mm along the longitudinal axis relative to the nozzle in a direction away from the nozzle outlet 139. It is foreseeable that in another embodiment, the discharge electrode subdivision can be adjusted relative to the counter electrode subdivision to achieve the same effect.

[0092] Discharge electrode division 170 presents the discharge electrode 175 of the annular ring form centered on the longitudinal axis, and is provided with a plurality of sharp protrusions 176, discharge portion 176a, discharge portion 176b, discharge portion 176c and discharge portion 176d, and charged particles can be emitted from the distal end of the discharge portion. Discharge portion 176a, 176b, 176c and 176d (total 6, wherein 2 are not shown) point to the suction nozzle inner chamber 104, and their distal end points to the volume that will form spray near the nozzle outlet 139 with respect to the electrode 175. The distal end of discharge portion 176a, 176b, 176c and 176d is located at a distance of 13mm from the longitudinal axis of inhaler 100, and is located at a distance of 5mm from the base plane that overlaps with the electrode 152 and base 160, on a side of the suction nozzle inner chamber 104 that deviates from the second part of the plane. By actuating the second fine adjustment screw, the distal end included in the discharge electrode can be moved relative to the nozzle outlet 139. The size of the discharge electrode section 170 along the longitudinal axis direction is relatively short compared to the size of the electrode section 150, which allows the discharge portion to be positioned at a certain range of distances relative to the nozzle outlet 139 on both sides of the base plane. When sparks occur in a specific liquid drug preparation, the distance of the discharge electrode 152 relative to the nozzle outlet 139 can be increased to reduce sparks. When the spray is deposited on the inner surface of the mouthpiece portion 102, reducing the distance can increase the discharge of the particles in the spray, and thus the atomized drug preparation can be more effectively delivered to the target tissue of the user.

[0093] The counter electrode subdivision 150 includes a counter electrode circuit cavity 180, and the discharge electrode subdivision 170 includes a discharge electrode circuit cavity 181. The nozzle subdivision 130 includes a circuit conduit 185, the counter electrode subdivision 150 includes a circuit conduit 186 in its flange 151 and a circuit conduit 187 passing through its body, and the discharge electrode subdivision 170 also includes a circuit conduit 188. These cavities and conduits can accommodate electrical components that connect the counter electrode 152 to ground and the discharge electrode 175 to a power supply unit, thereby reducing interference of the electronic components and wiring with the airflow through the body portion lumen 103 during use, or reducing relative movement between the nozzle subdivision 130, the counter electrode subdivision 150 and the discharge electrode subdivision 170 during adjustment. Establishing an electrical potential at the nozzle outlet 139 is achieved by connecting the nozzle 133 to the power supply unit via wiring or a liquid drug solution.

[0094] Figure 2 A view of the inhaler body 112 as seen from the lumen of the mouthpiece portion 102 is shown. The nozzle outlet 139 faces the observer and is centered on the longitudinal axis of the inhaler 100. The nozzle 133 protrudes through a base opening 161 in the base 160 of the counter electrode division 150, which allows the nozzle 133 to move through the base 160 and electrically insulates the two from each other. The base opening 161 is adjacent to the base 160, which includes the counter electrode 152 integrated in its surface. The base 160 is retained in a groove in the circumferential wall of the circuit cavity 180 in the counter electrode division 150 by a shape-fitting snap lock of the outer edge of the base 160. The discharge electrode division 170 includes a discharge electrode 175 having 6 sharp protrusions 176, from which discharge particles can emerge when in action. Contains Figure 1A 176e and 6 projections 176 of the discharge portion 176f not shown in the figure point to the longitudinal axis of the inhaler, to the nozzle 133, and can discharge the volume of the liquid drug preparation in the form of spray during operation. The distal ends of the 6 discharge portions 176a to 176f are located at an equal distance from the nozzle outlet, and are evenly distributed around the nozzle outlet, thereby allowing the symmetrical discharge of the spray to be formed from the nozzle outlet 139. The discharge electrode 175 is also retained in the groove in the circumferential wall of the circuit cavity 181 in the discharge electrode division 170 by the shape-matching snap lock of its outer edge. The discharge electrode 175 is located at a certain distance from the outer wall of the counter electrode division 150, thereby generating a gap 190 that the discharge electrode 175 is electrically isolated from the counter electrode division 150.

Claims

1. An inhaler (100) for inhaling a liquid pharmaceutical preparation, the inhaler (100) include: - a nozzle portion (102) comprising a circumferential wall (102a, 102b) extending from an edge of the suction opening, said circumferential wall (102a, 102b) surrounding an inner cavity (104), and - a body portion (101) coupled to the nozzle portion (102), the body portion (101) comprising a body (112) having a base (160), the base (160) facing the inner cavity (104) and defining the limit of the inner cavity (104) of the nozzle portion (102), the body (112) further comprising: i) a nozzle (133) comprising a nozzle inlet (134) at a first end of the nozzle (133) for receiving a liquid drug formulation and a nozzle outlet (139) at a second end of the nozzle (133) for discharging the drug formulation, wherein the nozzle (133) passes through the base (160) and a portion of the nozzle (133) including the nozzle outlet (139) extends into the lumen (104), ii) a counter electrode (152) arranged at the base (160) at a counter electrode distance from the nozzle outlet (139), the counter electrode distance defining an electric field path, iii) a discharge electrode (175), the discharge electrode (175) comprising a discharge portion (176a, 176b, 176c, 176d, 176e, 176f), the discharge portion (176a, 176b, 176c, 176d, 176e, 176f) being spaced apart from the nozzle outlet (139) by a discharge electrode distance, wherein the discharge electrode distance is greater than the pair of electrode distances; The inhaler (100) further comprises: - a power source electrically connected to at least one of the nozzle (133), the pair of electrodes (152), and the discharge electrode (175), and - an air inlet for allowing air for inhalation to enter the inner cavity (104); The invention is characterized in that the pair of electrodes (152) are arranged at the base (160) relatively close to the nozzle (133), and the discharge part (176a, 176b, 176c, 176d, 176e, 176f) is arranged relatively far away from the nozzle (133) compared with the pair of electrodes (152), and the discharge electrode distance is adjustable.

2. The inhaler (100) according to claim 1, in, The discharge electrode (175) includes a plurality of discharge portions (176a, 176b, 176c, 176d, 176e, 176f), wherein the discharge portions (176a, 176b, 176c, 176d, 176e, 176f) are at equal discharge electrode distances from the nozzle outlet (139) and are evenly distributed around the longitudinal axis of the portion of the nozzle (133) extending into the inner cavity (104).

3. The inhaler (100) according to claim 1, in, The nozzle (133) and the discharge electrode (175) are movable relative to each other along the longitudinal axis direction of the portion of the nozzle (133) extending into the inner cavity (104).

4. The inhaler (100) of claim 1, wherein the discharge portions (176a, 176b, 176c, 176d, 176e, 176f) are located outside the inner cavity (104).

5. The inhaler (100) according to claim 1, in, The distal end of the discharge portion (176a, 176b, 176c, 176d, 176e, 176f) is directed toward the longitudinal axis of the portion of the nozzle (133) extending into the lumen (104).

6. The inhaler (100) according to claim 1, in, The distance between the electrodes is adjustable.

7. The inhaler (100) according to claim 1, in, The inhaler (100) further comprises a counter electrode actuator (142) capable of moving the nozzle (133) and the counter electrode (152) relative to each other.

8. The inhaler (100) according to claim 1, in, The nozzle (133) and the pair of electrodes (152) are movable relative to each other along the longitudinal axis direction of the portion of the nozzle (133) extending into the lumen (104).

9. The inhaler (100) according to claim 1, in, The nozzle outlet (139) coincides with a conical base perpendicular to the longitudinal axis of the portion of the nozzle (133) extending into the inner cavity (104), and the side of the conical base facing the nozzle (133) also faces the pair of electrodes (152).

10. The inhaler (100) according to claim 1, in, The pair of electrodes (152) are annular and are arranged perpendicular to and centered on the longitudinal axis of the portion of the nozzle (133) extending into the lumen (104).

11. A method for adjusting the inhaler (100) according to any one of claims 1 to 10, in, The method comprises the step of adjusting the discharge electrode distance.

12. The method according to claim 11, in, The inhaler (100) further comprises a discharge electrode actuator capable of moving the nozzle (133) and the discharge electrode (175) relative to each other; as well as Wherein, in the method, the step of adjusting the discharge electrode distance is performed by moving the nozzle (133) and the discharge electrode (175) relative to each other.

13. The method according to claim 11 or 12, in, The inhaler (100) further comprises a discharge electrode fixing device for fixing the nozzle (133) in a suitable position relative to the discharge electrode (175); and The method further comprises the step of fixing the nozzle (133) in a suitable position relative to the discharge electrode (175).

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