Electronic inhaler and method of adjusting the same

Abstract

The invention relates to a method for adjusting an inhaler for inhalation of a liquid drug formulation, and an inhaler with a mouthpiece for use in said method. The method is for adjusting an inhaler. The inhaler comprises a mouthpiece portion with an inner cavity and a coupled body portion. The body portion comprises a body with a base facing the inner cavity. The body further comprises a mouthpiece with an outlet for discharge of the drug formulation extending from the base into the inner cavity, a counter electrode at the base at a counter electrode distance from the mouthpiece outlet, and a discharge electrode at a discharge electrode distance from the mouthpiece outlet. The inhaler further comprises a power source and an air inlet. The method comprises the step of adjusting the electrodes relative to the mouthpiece outlet of the inhaler.

Description

Technical Field

[0001] This invention relates to a method for adjusting an inhaler for inhaling a liquid drug formulation. The method for adjusting the inhaler uses an inhaler comprising: - A suction nozzle portion, comprising a circumferential wall extending from the edge of the suction opening, the circumferential wall surrounding an inner cavity, and - A body portion, which is coupled to the nozzle portion, the body portion including a body having a base facing the inner cavity and defining the limits of the inner cavity of the nozzle portion, the body further including: i) A nozzle comprising a nozzle inlet at a first end for receiving a liquid pharmaceutical preparation and a nozzle outlet at a second end for discharging the pharmaceutical preparation, wherein the nozzle extends through a base and a portion of the nozzle, including the nozzle outlet, extends into an inner lumen. ii) A counter electrode, which is arranged at the base, relatively close to the nozzle, and at a distance from the nozzle outlet from the counter electrode, the distance defining the electric field path. iii) A discharge electrode comprising a discharge portion disposed relatively far from the nozzle compared to the counter electrode, wherein the discharge portion is at a distance from the nozzle outlet from the discharge electrode, wherein the distance of the discharge electrode is greater than the distance of the counter electrode. The inhaler further includes: - A power source electrically connected to at least one of the nozzle, the counter electrode, and the discharge electrode, and - Air inlet, which allows air for intake to enter the cavity. Background Technology

[0002] Electronic inhalers are known in the art for their ability to atomize liquid drug formulations, including their manufacture and tuning. Compared to manual inhalers, electronic inhalers offer numerous advantages, particularly the relatively uniform particle size achieved through atomization, and consequently, better delivery and more precise dosing compared to mechanical or pressurized inhalers.

[0003] These electronic inhalers include a body portion with an air inlet through which airflow can pass. The air inlet is fluidly connected to an inner cavity within a mouthpiece portion, which includes an inhalation opening arranged adjacent to the body portion. Within this inner cavity, a liquid medication formulation can be atomized, and the user inhales the atomized medication formulation carried by the airflow through the inhalation opening. A mouthpiece outlet at the end of the nozzle merges into the inner cavity of the mouthpiece portion and is arranged to atomize the liquid medication composition into the inner cavity. Typically, the mouthpiece is a fine capillary needle with a mouthpiece inlet at one end that allows liquid medication formulation contained in a reservoir to enter the mouthpiece. The reservoir may be provided with the inhaler fluidly connected to the mouthpiece inlet, but it may also be provided later, for example, as a replacement refill. A pump may be provided, but is not essential for its function; capillary force generated by the mouthpiece or pressurized reservoir can also achieve proper flow of the liquid medication formulation through the mouthpiece. A pump may be preferred. The nozzle also has a nozzle outlet through which the drug formulation passes and is atomized into the inner cavity of the mouthpiece portion. Typically, the user inhales, causing an airflow through the inner cavity that carries the atomized drug formulation to the target tissues of the user's respiratory system.

[0004] To atomize a liquid drug formulation into the cavity, a Taylor cone is established at the nozzle exit by means of the potential between the nozzle and the counter electrode. This is typically a stable Taylor cone with a single jet, but can also be a temporary Taylor cone. The Taylor cone is a typical cone-shaped liquid volume. The Taylor cone presents an end from which the jet emerges. At a distance from the Taylor cone, the jet breaks into charged liquid particles that move away from the Taylor cone; for the purpose of inhaling the drug formulation, these particles are approximately 0.1 to 10 micrometers in size. The electric field strength between the counter electrode and the nozzle exit is a major determinant of the particle size atomized by the jet. These atomized particles together form a spray in the air within the cavity of the mouthpiece portion, and this spray can be inhaled along 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 size in order to effectively deliver it to selected respiratory tissues. The discharge of particles in the spray is achieved by a discharge electrode having a sharp tip that acts as a discharge section from which corona particles with an opposite charge to the spray particles can be emitted. These corona particles collide with and merge with particles in the spray, thus causing the spray to discharge.

[0005] The drawback of existing electronic inhalers is that they are designed and manufactured accordingly to deliver specific drug formulations to specific tissues of the respiratory system, and each formulation requires the manufacture of different inhalers with different specifications. Summary of the Invention

[0006] The object of this invention is to provide a method for adjusting an electronic inhaler after it has been manufactured to deliver a selected pharmaceutical formulation to selected tissues of the respiratory system.

[0007] Therefore, the method includes the step of adjusting the distance between the counter electrodes.

[0008] In this way, inhalers can be manufactured inexpensively, producing a single model, and after manufacturing, the inhaler can be adjusted to the specifications required for use with the selected liquid drug formulation. 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 also reduces manufacturing errors, where faulty parts might be incorporated into the inhalers. Those skilled in the art can determine the required electrode distance to atomize the selected liquid drug formulation into a spray with the desired particle size and spray shape for delivery to selected tissues of the respiratory system.

[0009] Setting the nozzle outlet relatively close to the counter electrode can generate a spray to improve delivery to alveolar tissue. Setting the nozzle outlet at an increased distance from the counter electrode can generate a spray to improve delivery to any tissue selected from alveoli, bronchioles, bronchi, or trachea.

[0010] The method may also include the step of adjusting the distance to the discharge electrode. Setting the nozzle outlet at an appropriate distance from the discharge electrode produces a spray that is wide enough to ensure uniform particle size, but also narrow enough to reduce loss of the atomized drug formulation on the circumferential walls of the mouthpiece portion of the inhaler, thereby improving the inhaler's delivery of liquid drug formulations to any selected target tissue of the respiratory system.

[0011] Setting the nozzle outlet at an appropriate distance from the counter electrode and / or discharge electrode to target the nebulized drug formulation to specific tissues of the respiratory system is not universally applicable for different drug formulations, and even changes in concentration can affect nebulization. It is necessary to determine suitable settings for each different liquid drug formulation, a determination that can be performed by any technician by determining the particle size in the spray. These settings include the potential to be established on the nozzle, counter electrode, and discharge electrode, wherein the counter electrode is typically set to 0 volts, and, according to the invention, further include the counter electrode distance and / or discharge electrode distance, which can be set post-manufacturing for fine-tuning the inhaler for use with the desired liquid drug formulation.

[0012] US 2019209791 describes an inhaler in which the discharge electrode distance can be selected during the manufacture of 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 manufacture to control the width of the spray.

[0013] According to an advantageous embodiment, the step of adjusting the distance between the electrodes is performed by cutting off the portion of the nozzle that extends into the inner lumen.

[0014] In this way, the relatively long portion of the nozzle can be modified cheaply, and the counter electrode distance can be reduced, without the need for adjustment devices to adjust the portion of the nozzle extending into the lumen. This allows for the manufacture of very inexpensive inhalers that can be modified as needed after production. The truncated nozzle portion removes the old nozzle outlet and creates a new nozzle outlet at the desired counter electrode distance. Those skilled in the art can use their common sense to determine the length by which the portion extending into the lumen should be truncated to obtain the desired characteristics. Once determined, this step can be performed on all inhalers for the same liquid drug formulation targeting the same tissue.

[0015] According to an advantageous embodiment, the inhaler further includes a counter electrode actuator capable of moving the mouthpiece and the counter electrode relative to each other; and In this method, the step of adjusting the distance between the counter electrode is performed by moving the nozzle and the counter electrode relative to each other.

[0016] In this way, more precise adjustments are possible. The inhaler can be adjusted, and if it is detected that the adjustment does not conform to the proper settings for delivering a selected liquid drug formulation to selected tissues of the respiratory system, it can be readjusted.

[0017] According to an advantageous embodiment, the inhaler further includes a counter electrode fixing device for securing the mouthpiece in place relative to the counter electrode; and The method further includes the step of fixing the nozzle in place relative to the counter electrode.

[0018] In this way, the method provides an inhaler with consistent performance. Ultimately, after adjusting the portion of the nozzle extending into the lumen, the counter electrode distance can be securely fixed at the desired distance, thus providing an inhaler that maintains the desired characteristics and is not easily readjusted or tampered with. Therefore, the method may further include a step of fixing the nozzle relative to the counter electrode in place after the step of adjusting or readjusting the counter electrode distance. Preferably, the counter electrode fixing device can only be operated by personnel authorized to operate inhalers in the inhaler market, and therefore its function is compliant and remains compliant.

[0019] According to an advantageous embodiment, the inhaler's nozzle is a removable nozzle; and In this method, the step of adjusting the distance between the 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.

[0020] In this way, an inhaler manufactured for one purpose can be converted into an inhaler suitable for delivering different liquid drug formulations and / or targeting different tissues of the respiratory system by simply replacing a removable nozzle with a replacement nozzle that extends further or closer into the lumen than the removable nozzle. Thus, for example, manufacturers can quickly respond to changes in market demand by rapidly and inexpensively converting inhalers. When the function may change after prolonged use due to the accumulation of dirt or components of liquid drug formulations at or inside the nozzle or at the nozzle outlet, or due to wear of the nozzle or nozzle coating, the inhaler can also be refurbished in this way with the same replacement nozzle. Therefore, refurbishing an inhaler with a clean, unused replacement nozzle of the same size allows the inhaler to be adjusted to its original desired setting.

[0021] According to an advantageous embodiment, the nozzle preferably includes a marking at the portion of the nozzle extending into the lumen; and During the step of adjusting the distance between the electrodes, a marker is used to guide the adjustment.

[0022] In this way, visual inspection allows for checking the correct assembly and setting of the inhaler. The nozzle can be easily adjusted by visually inspecting the position of the markings or by cutting at the markings. Visually inspecting the markings relative to the base (where the counter electrode is located) can also indicate that the nozzle is not properly engaged with the nozzle section, resulting in malfunction or incorrect operation. For example, the markings can indicate the distance from the nozzle outlet or the distance to the base. The markings can include etching or engraving on the nozzle, or the application of markings or a coating with markings on the nozzle.

[0023] According to an advantageous embodiment, the inhaler further includes a discharge electrode actuator capable of moving the mouthpiece and the discharge electrode relative to each other; and In this method, the step of adjusting the distance between the discharge electrodes is performed by moving the nozzle and the discharge electrodes relative to each other.

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

[0025] According to an advantageous embodiment, the inhaler further includes a discharge electrode fixing device for fixing the nozzle in place relative to the discharge electrode; and The method further includes the step of fixing the nozzle in the appropriate position relative to the discharge electrode.

[0026] In this way, the method provides an inhaler with consistent performance. Ultimately, after adjusting the portion of the nozzle extending into the lumen, the discharge electrode distance can be securely fixed at the desired distance, thus providing an inhaler that maintains the desired characteristics and is not easily prone to accidental readjustment or tampering. Therefore, the method may further include a step of fixing the nozzle relative to the discharge electrode in the appropriate position after the step of adjusting or readjusting the discharge electrode distance. Preferably, the discharge electrode fixing device can only be operated by personnel authorized to operate inhalers in the inhaler market, and therefore its function is compliant and remains compliant.

[0027] The present invention also relates to an inhaler for inhaling liquid pharmaceutical preparations, the inhaler comprising: - A suction nozzle portion, comprising a circumferential wall extending from the edge of the suction opening, the circumferential wall surrounding an inner cavity, and - A body portion, which is coupled to the nozzle portion, the body portion including a body having a base facing the inner cavity and defining the limits of the inner cavity of the nozzle portion, the body further including: i) A nozzle comprising a nozzle inlet at a first end for receiving a liquid pharmaceutical preparation and a nozzle outlet at a second end for discharging the pharmaceutical preparation, wherein the nozzle extends through a base and a portion of the nozzle, including the nozzle outlet, extends into an inner lumen. ii) A counter electrode, which is arranged at the base, relatively close to the nozzle, and at a distance from the nozzle outlet from the counter electrode, the distance defining the electric field path. iii) A discharge electrode comprising a discharge portion disposed relatively away from the nozzle, wherein the discharge portion is at a distance from the nozzle outlet from the discharge electrode, wherein the distance from the discharge electrode is greater than the distance from the counter electrode. The inhaler further includes: - A power source electrically connected to at least one of the nozzle, the counter electrode, and the discharge electrode, and - Air inlet, which allows air for intake to enter the cavity.

[0028] The present invention also relates to an electronic inhaler as described in the preamble of claim 1. For the sake of brevity, it is stated that these inhalers have the same disadvantages as those discussed in the preamble of claim 1.

[0029] The object of the present invention is to provide an inhaler that is adjustable after manufacture to improve the delivery of selected liquid pharmaceutical formulations to selected tissues of the respiratory system.

[0030] Therefore, the inhaler described in the preceding section is characterized by an adjustable electrode distance.

[0031] In this way, an inhaler is provided that is inexpensive and can be adjusted post-manufacturing to the specifications required for use with a selected liquid drug formulation. The inhaler can be adjusted by an authorized or qualified skilled person. Adjustment of the inhaler according to the invention can be performed immediately at the manufacturing site after manufacturing, or can be performed later by, for example, a market-authorized supplier, general practitioner, or pharmacist, to ensure proper dosing and targeting of the liquid drug formulation to selected tissues of the respiratory system.

[0032] According to an advantageous embodiment, the nozzle preferably includes a marking at the portion of the nozzle that extends into the lumen.

[0033] In this way, visual inspection allows for checking the correct assembly and setting of the inhaler. The nozzle can be easily adjusted by visually inspecting the position of the markings or by cutting at the markings. Visually inspecting the markings relative to the base (where the counter electrode is located) can also indicate that the nozzle is not properly engaged with the nozzle section, resulting in malfunction or incorrect operation. For example, the markings can indicate the distance from the nozzle outlet or the distance to the base. The markings can include etching or engraving on the nozzle, or applied markings or coatings with markings.

[0034] According to an advantageous embodiment, the inhaler further includes a counter electrode actuator capable of moving the nozzle and the counter electrode relative to each other.

[0035] In this way, the electrode distance setting can be controlled without touching the nozzle. Touching the nozzle can affect its characteristics due to damage or dirt buildup on its surface. For example, racks and pinions allow for quick adjustments. A fine-tuning screw with a worm gear can provide enhanced adjustability depending on the screw's pitch.

[0036] According to an advantageous embodiment, the nozzle and the counter electrode can be moved relative to each other along the longitudinal axis of the portion of the nozzle extending into the lumen.

[0037] In this way, the distance between the counter electrode and the nozzle is adjustable relative to the electric field established between the nozzle outlet and the counter electrode, and has a substantially linear response, thus making it easier to set up an electronic inhaler for use with selected liquid medications delivered to selected tissues of the respiratory system. When adjusted along a single axis, less consideration is needed regarding the three-dimensional configuration of the nozzle and counter electrode.

[0038] In this way, the distance between the discharge electrodes can be adjusted along a single axis, with less consideration for the three-dimensional arrangement of the nozzle, counter electrode, and discharge electrode, making adjustment easier.

[0039] According to an advantageous embodiment, the nozzle outlet coincides with a conical base surface perpendicular to the longitudinal axis of the portion of the nozzle extending into the inner cavity, and the side of the conical base surface facing the nozzle also faces the counter electrode.

[0040] In this way, the counter electrode is positioned such that, during use, particles from the spray do not move toward 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, thus providing a lower dosage than intended in the prior art, wherein more wetting and contamination occurs over time compared to the inhaler according to the invention.

[0041] According to an advantageous embodiment, the counter electrode is annular and is arranged perpendicular to the longitudinal axis of the portion of the nozzle extending into the inner cavity and centered on that longitudinal axis.

[0042] In this way, the inhaler can produce a spray, a larger portion of which can be delivered to the target tissue, making the inhaler more effective.

[0043] According to an advantageous embodiment, the nozzle and / or counter electrode and / or counter electrode actuator are configured to change the counter electrode distance in a discrete manner.

[0044] Due to discrete (i.e., stepwise) adjustability, preset settings are provided on the inhaler, allowing manufacturers, physicians, pharmacists, or users to easily and with reduced error adjust the inhaler, thus providing a spray that reliably delivers the drug formulation to the intended tissue during use. Shape locks, or ratchet or bead-like shapes, formed at discrete positions of the nozzle or electrode actuators can provide discrete adjustability. This also cleverly locks the setting in the desired position.

[0045] According to an advantageous embodiment, the inhaler further includes a counter electrode fixing device for fixing the nozzle in place relative to the counter electrode.

[0046] In this way, once the inhaler has been set in the desired position, the manufacturer, general practitioner, pharmacist, or user can ensure the inhaler is set correctly and thus ensure reliable delivery of the medication. A preset inhaler is not easily altered unintentionally due to factors such as accidental manipulation by the user, vibration, or improper use.

[0047] According to an advantageous embodiment, the distance between the discharge electrodes is adjustable.

[0048] In this way, a single model of inhaler can be adapted for use with different liquid drug formulations. Spray characteristics (e.g., spray volume, spray shape, average particle charge) depend on the properties of the liquid drug formulation to be atomized. Therefore, the adjustability of the discharge electrode distance allows for the production of a single model for different liquid drug formulations, resulting in cheaper manufacturing.

[0049] According to an advantageous embodiment, the distal end of the discharge portion points toward the longitudinal axis of the portion of the nozzle that extends into the inner cavity.

[0050] In this way, the discharge of the spray can be improved. Because the corona discharge particles move away from the distal end in the direction pointed to by the distal end, it is preferable to point the distal end toward the volume associated with the nozzle outlet of the inner cavity, 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°, and even more preferably between 35° and 75°.

[0051] According to an advantageous embodiment, the discharge electrode includes a plurality of discharge portions, preferably at least three, more preferably at least four, and even more preferably at least six, wherein the discharge portions are equidistant from the nozzle outlet by a discharge electrode distance and are uniformly distributed around the longitudinal axis of the portion of the nozzle extending into the inner cavity.

[0052] In this way, the discharge from the spray will be more uniform.

[0053] According to an advantageous embodiment, the nozzle and the discharge electrode can be moved relative to each other along the longitudinal axis of the portion of the nozzle extending into the inner cavity.

[0054] In this way, the distance between the discharge electrodes can be adjusted along a single axis, with less consideration for the three-dimensional arrangement of the nozzle, counter electrode, and discharge electrode, making adjustment easier.

[0055] According to an advantageous embodiment, the discharge portion is located outside the inner cavity.

[0056] In this way, interference from the discharge electrode with the Taylor cone, jet and / or spray formation is reduced, and the delivery efficiency of drug formulations can be improved.

[0057] Finally, the present invention relates to the use of a nozzle in a method for adjusting an inhaler for inhaling a liquid pharmaceutical preparation or in an inhaler for inhaling a liquid pharmaceutical preparation.

[0058] In this way, the inhaler can be adapted to market demand and / or inexpensively and easily refurbished for use with selected liquid drug formulations. Attached Figure Description

[0059] The invention will now be described with reference to the accompanying drawings, in which... Figure 1A A cross-sectional view of the inhaler according to the present invention is shown; Figure 1B It shows along according to Figure 1A The cross section taken along the longitudinal axis of the embodiment; and Figure 2 It shows according to Figure 1A A top view of the inhaler body of an embodiment. Detailed Implementation

[0060] An exemplary embodiment is an inhaler 100 having a tubular shape, comprising two releasably connected portions: a body portion 101, which is formed by a first cylindrical portion 101a having a circumferential wall and an open end; and a mouthpiece portion 102, which is formed by a second cylindrical portion 102a releasably connected to a third cylindrical portion 102b, both cylindrical portions also having circumferential walls and open ends. The body portion surrounds a body portion cavity 103, and the mouthpiece portion surrounds a mouthpiece portion cavity 104. The inhaler 100 has a longitudinal axis along its length extending through the centerline of the three cylindrical portions 101a, 102a, and 102b. The cavities 103 and 104 form an air duct through which air can flow from an air inlet opening 106 in an air inlet cover 105 covering an inhaler inlet 108 of the body portion 101 toward an inhaler outlet 110, thereby allowing the user to inhale an airflow. The air inlet cap 105 further includes a slot 107 through which wiring for supplying power or tubing for supplying liquid medication can pass, thereby allowing the air inlet cap 105 to be removed or replaced with a different air inlet cap if the operation of the inhaler requires more or less airflow through the air duct of the inhaler 100. Removal of the air inlet cap 105 also allows access to the adjustment mechanisms of the inhaler 100, as explained later. The closed outlet cap 111 can be fitted for storage of the inhaler 100 and can be removed before use. The inhaler outlet cap 111 prevents dust from entering the air duct through the inhaler outlet 110 and into the cavity 105 of the mouthpiece portion 102.

[0061] The body portion 101 holds the inhaler body 112. The inhaler body 112 is also cylindrical. The centerline of the inhaler body 112 is aligned with the longitudinal axis of the inhaler 100. The inhaler body 112 is fastened to the interior of the body portion 101 by three bolts, namely bolts 113a, 113b, and 113c (not shown in cross-section), which engage with matching threads in threaded through holes in the cylindrical wall 115 of the body portion 101. Bolt heads 114a, 114b, and 114c (not shown in cross-section) are located outside the body portion 101, allowing bolts 113a, 113b, and 113c to be tightened or loosened. The bolt length extends into the cavity 104 of the body portion 101. Bolts 113a, 113b, and 113c engage with grooves 131 in the outer surface of the cylindrical wall 132 of the inhaler body 112 via their respective distal ends 116a, 116b, and 116c (the latter two ends are obscured by the inhaler body 112 and are not visible), thereby securing the inhaler body 112 and centering it within the air duct of the inhaler 100. In this way, air can be drawn from the inhaler inlet 108 along the inhaler body 112 suspended at the center of the body portion cavity 103 through the air duct, and subsequently through the mouth portion cavity 104, for inhalation by the user via the inhaler outlet 110. During operation, the airflow may include atomized drug formulations. Figure 1B Further details about the inhaler body are discussed in the paper.

[0062] Figure 1B It shows along according to Figure 1A The embodiment is a cross-section taken along the longitudinal axis. The inhaler body 112 is formed by three cylindrical portions: the mouthpiece portion 130, the counter electrode portion 150, and the discharge electrode portion 170. The centerlines of each inhaler body portion 130, 150, and 170 are also aligned along the longitudinal axis. The mouthpiece portion 130, the counter electrode portion 150, and the discharge electrode portion 170 are movable relative to each other along the longitudinal axis of the inhaler.

[0063] The nozzle section 130 is held in place by engaging the distal ends 116a, 116b, and 116c of three corresponding bolts 113a, 113b, and 113c with grooves 131 provided in the outer surface of the cylindrical wall 132 of the nozzle section, thereby suspending the nozzle section 130 at the center of the body section 101. The nozzle section 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 seated in a through-hole passing through the centerline of the nozzle section. 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 or alternatively connected via conduit to the male Luer-Lok fitting 137. A through-hole in the retaining element 136 acts as a snap-lock on the fitting by fitting into a groove 138 provided on the male Luer-Lok fitting 136. This allows the liquid medication to enter and pass through the nozzle 133. At the opposite end of the nozzle 133 from the nozzle inlet 134, a nozzle outlet 139 is provided from which the liquid medication can be atomized into a spray that can be inhaled by the user. The nozzle 133 is partially surrounded by a 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.

[0064] The counter electrode portion 150, having a cylindrical shape and a flange 151, includes a counter electrode 152 and a nozzle shaft 153. The nozzle shaft 153 holds the nozzle sleeve 140 and allows the counter electrode portion 150 to slide relative to the nozzle portion 130 along a longitudinal axis. The nozzle shaft 153 presents a nozzle opening 154 at its end, through which a terminal nozzle section 141 passes. The nozzle portion 130 also includes a fine-tuning screw 142 that is rotatably engaged with the nozzle portion 130. A bolt head 143 and a nut 144 hold the fine-tuning screw worm shaft 145 in place, thereby allowing the fine-tuning screw 142 and worm 146 to rotate. The fine-tuning screw 142 engages with a threaded through-hole 155 provided in the flange 151 on the counter electrode portion 150. Rotation of the fine-tuning screw 142 allows the counter electrode portion 150 to be moved in either direction relative to the nozzle portion 130 along the longitudinal axis. The nut 144 can also be tightened to prevent rotation of the fine-tuning screw 142, thereby effectively locking the position and thus distance of the nozzle outlet 139 relative to the counter electrode 152. The counter electrode portion 150 also presents a base 160 having a base opening 161 and a surface facing the mouthpiece cavity 104. At the surface of the base, an annular counter electrode 152 is positioned centered on the longitudinal axis along which the nozzle 133 extends through the base opening 161 into the mouthpiece cavity 104, with its nozzle outlet 139 merging into said cavity. The annular counter electrode 152 has a width of 2 mm and is positioned such 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 portion relative to the base plane coinciding with the counter electrode 152 and the base 160, but can be adjusted within a 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. A preferred adjustment range is 0-20 mm from the base plane in the direction toward the inner cavity, thereby reducing wetting of the counter electrode 139.

[0065] The discharge electrode portion 170 includes a counter electrode shaft 171 for accommodating the counter electrode portion 150, and is slidably arranged around the counter electrode portion 150 via the shaft 171.

[0066] The discharge electrode portion 170 can be moved relative to the nozzle portion 130 using a second fine-tuning screw. The worm shaft of the second fine-tuning screw is freely rotatable within a through-hole in the nozzle portion 130 and secured by a nut. The worm of the fine-tuning screw extends via the through-hole, thereby allowing free rotation within the flange 151 of the counter electrode portion 150. The worm engages with a mating threaded hole in the discharge electrode portion 170, thereby allowing movement of the discharge electrode portion 170 relative to the nozzle portion 130 (not shown). In this embodiment, the discharge electrode can be adjusted relative to the nozzle along the longitudinal axis in a direction away from the nozzle outlet 139 from the nozzle. It is foreseeable that in another embodiment, the discharge electrode portion can be adjusted relative to the counter electrode portion to achieve the same effect.

[0067] The discharge electrode portion 170 presents a discharge electrode 175 in the form of a ring centered on the longitudinal axis, and is provided with multiple sharp protrusions 176, discharge portions 176a, 176b, 176c, and 176d, from which charged particles can be emitted from the distal ends of the discharge portions. The discharge portions 176a, 176b, 176c, and 176d (a total of 6, 2 of which are not shown) point towards the mouthpiece cavity 104, their distal ends pointing relative to the counter electrode 175 towards the volume near the mouthpiece outlet 139 where a spray will be formed. The distal ends of the discharge portions 176a, 176b, 176c, and 176d are located at a distance of 13 mm from the longitudinal axis of the inhaler 100, and at a distance of 5 mm from the base plane coinciding with the counter electrode 152 and the base 160, on the side of this plane opposite to the second portion of the mouthpiece cavity 104. By actuating the second fine-tuning screw, the distal end included in the discharge electrode can be moved relative to the nozzle outlet 139. The dimension of the discharge electrode portion 170 along the longitudinal axis is relatively shorter than that of the counter electrode portion 150, allowing the discharge portion to be positioned at a range of distances relative to the nozzle outlet 139 on both sides of the base plane. When a particular liquid pharmaceutical formulation sparks, the distance of the discharge electrode 152 relative to the nozzle outlet 139 can be increased to reduce sparking. Reducing this distance can improve the discharge of particles in the spray when the spray deposits on the inner surface of the mouthpiece portion 102, and thus more effectively deliver the atomized pharmaceutical formulation to the user's target tissue.

[0068] The counter electrode portion 150 includes a counter electrode circuit cavity 180, and the discharge electrode portion 170 includes a discharge electrode circuit cavity 181. The nozzle portion 130 includes a circuit conduit 185, the counter electrode portion 150 includes a circuit conduit 186 in its flange 151 and a circuit conduit 187 passing through its body, and the discharge electrode portion 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 the power supply unit, thereby reducing interference from the electronic components and wiring on airflow through the body portion cavity 103 during use, or reducing relative movement between the nozzle portion 130, the counter electrode portion 150, and the discharge electrode portion 170 during adjustment. A potential is established at the nozzle outlet 139 by connecting the nozzle 133 to the power supply unit via wiring or a liquid drug solution.

[0069] Figure 2 A view of the inhaler body 112 as seen from the interior of the mouthpiece portion 102 is shown. The mouthpiece outlet 139 faces the observer and is centered on the longitudinal axis of the inhaler 100. The mouthpiece 133 protrudes through a base opening 161 in the base 160 of the counter electrode portion 150, the base opening 161 allowing the mouthpiece 133 to move through the base 160 and electrically insulating the two from each other. The base opening 161 is adjacent to the base 160, which includes a counter electrode 152 integrated into its surface. The base 160 is held in a recess in the circumferential wall of the circuit cavity 180 in the counter electrode portion 150 by a snap-lock mechanism formed by the shape of its outer edge. The discharge electrode portion 170 includes discharge electrodes 175 with six sharp protrusions 176 from which discharge particles can emerge during operation. Figure 1A The six protrusions 176 of the discharge portions 176e and 176f (not shown) point towards the longitudinal axis of the inhaler and towards the nozzle 133, allowing the liquid drug formulation to be expelled in a spray form during operation. The distal ends of the six discharge portions 176a to 176f are located at equal distances from the nozzle outlet and are evenly distributed around the nozzle outlet, thereby allowing symmetrical discharge of a spray from the nozzle outlet 139. The discharge electrode 175 is also secured in a groove in the circumferential wall of the circuit cavity 181 in the discharge electrode portion 170 by the shape of its outer edge engaging with a snap-lock. The discharge electrode 175 is located at a distance from the outer wall of the counter electrode portion 150, thereby creating a gap 190 that electrically isolates the discharge electrode 175 from the counter electrode portion 150.

Claims

1. An inhaler (100) for inhaling a liquid drug formulation, the inhaler (100) comprising: - A suction nozzle portion (102) comprising circumferential walls (102a, 102b) extending from the edge of the suction opening, the circumferential walls (102a, 102b) surrounding an inner cavity (104), and - A body portion (101) connected to the nozzle portion (102), the body portion (101) including a body (112) having a base (160) facing the cavity (104) and defining the limits of the cavity (104) of the nozzle portion (102), the body (112) further including: i) A nozzle (133) comprising a nozzle inlet (134) at a first end for receiving a liquid pharmaceutical preparation and a nozzle outlet (139) at a second end for discharging the pharmaceutical preparation, 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) disposed at the base (160) at a distance from the nozzle outlet (139) from the counter electrode, the counter electrode distance defining the electric field path. iii) A discharge electrode (175) comprising discharge portions (176a, 176b, 176c, 176d, 176e, 176f) and the nozzle outlet (139) at a distance from the discharge electrode, wherein the distance from the discharge electrode is greater than the distance between the two electrodes; The inhaler (100) further includes: - A power source electrically connected to at least one of the nozzle (133), the pair electrode (152), and the discharge electrode (175), and - An air inlet that allows air for intake to enter the cavity (104). The feature is that the pair of electrodes (152) is arranged at the base (160) relatively close to the nozzle (133), the discharge portions (176a, 176b, 176c, 176d, 176e, 176f) are relatively far from the nozzle (133) relative to the pair of electrodes (152), and the distance between the pair of electrodes is adjustable.

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

3. The inhaler (100) according to claim 1, wherein, The nozzle (133) and the electrode pair (152) are movable relative to each other along the longitudinal axis of the portion of the nozzle (133) extending into the cavity (104).

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

5. The inhaler (100) according to claim 1, wherein, The electrode pair (152) is annular and is arranged perpendicular to the longitudinal axis of the portion of the nozzle (133) extending into the cavity (104) and centered on the longitudinal axis.

6. The inhaler (100) according to claim 2, wherein, The nozzle (133) and / or the electrode pair (152) and / or the electrode pair actuator (142) are configured to change the distance between the electrode pairs in a discrete manner.

7. The inhaler (100) according to claim 1, wherein, The distance between the discharge electrodes is adjustable.

8. The inhaler (100) according to claim 1, wherein, The distal end of the discharge portion (176a, 176b, 176c, 176d, 176e, 176f) points toward the longitudinal axis of the portion of the nozzle (133) that extends into the inner cavity (104).

9. The inhaler (100) according to claim 1, wherein, The discharge electrode (175) includes a plurality of discharge portions (176a, 176b, 176c, 176d, 176e, 176f), which are equidistant from the nozzle outlet (139) by a discharge electrode distance and are uniformly distributed along the longitudinal axis of the portion of the nozzle (133) extending into the inner cavity (104).

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

11. The inhaler (100) according to any one of claims 1-10, wherein the discharge portions (176a, 176b, 176c, 176d, 176e, 176f) are located outside the inner cavity (104).

12. A method for adjusting an inhaler (100) according to any one of claims 1-11, wherein the method includes the step of adjusting the distance between the electrodes.

13. The method of claim 12, wherein the step of adjusting the distance between the electrodes is performed by cutting off the portion of the nozzle (133) extending into the lumen (104).

14. The method according to claim 12 or 13, wherein, The inhaler (100) further includes a counter electrode actuator (142) capable of moving the nozzle (133) and the counter electrode (152) relative to each other; and In this method, the step of adjusting the distance between the electrodes is performed by moving the nozzle (133) and the electrodes (152) relative to each other.

Images