JP4695940B2 - Inhaler - Google Patents

Description

The present invention relates to an inhaler, and more particularly to an inhaler that ejects liquid medicines such as drugs, aromas, and nicotine as fine droplets and inhales a user.

In recent years, with the advancement of medicine and science, the average life span has been extended and it is becoming an aging society. On the other hand, new diseases and infectious diseases due to changes in eating habits and living environment, environmental pollution, viruses and fungi have been found, and people's health concerns are increasing. In particular, in countries called developed countries, an increase in patients with lifestyle-related diseases such as diabetes and hypertension is a problem.

For example, insulin patients are required for diabetics, but conventionally, administration by meal injection has been common. Administration by a syringe imposes considerable pain on a patient, and as a solution for this, administration of a drug via the respiratory system is considered. There are generally three ways to do this. Metered dose inhalers, dry powder inhalers, and nebulizers.

Metered dose inhalers (MDI) are widely used for the treatment of asthma. This MDI is equipped with a valve that ejects a metered dose of aerosol during operation, and the main body of the device can be made compact and convenient to carry, but the change in the ejected dose is considerable. It becomes the range. Also, the use of MDI requires some degree of synchronization between manual valve operation and inhalation, and many users find this synchronization difficult.

A dry powder inhaler (DPI) must be inhaled with a large amount of air in order to be fluid and to administer an effective powder inside the bronchial system. This seems to avoid the problem of synchronization between the MDI valve operation and inhalation, but inhaling a large amount of air imposes a considerable burden on the user. Also, DPI cannot be used for such patients because it may cause asthma attacks in those who are sensitive to moisture and sensitive to inhaled powder. In addition, since the suction input varies from person to person, the amount administered by a person varies.

Nebulizers generate aerosols by atomizing a liquid in a carrier gas stream, but require a gas compressor that operates continuously and a large amount of compressed gas. In general, aerosol droplet size is a function of carrier gas pressure and velocity, so it is not easy to vary the concentration of the drug independently in the gas stream. Inhalation also reduces the pressure in the nebulizer nozzle, so dose and particle size are affected by the duration and intensity of each breath.

As described above, in general, these devices have a problem in accuracy of administering an appropriate amount of a drug having an appropriate particle size to an application site, and are limited to use of only a drug having a wide margin in dose. In either case, the current administration is dependent on the user's technique for proper administration.

On the other hand, not only is there a need for improved dosing systems that optimize current nasal and pulmonary treatments using locally acting drugs, but medical advances have led to protein, peptides, analgesics, etc. Administration of drugs to the lung (transpulmonary) has been shown to be significantly advantageous over conventional means of oral or injection administration. However, the conventionally proposed inhalers cannot be used in the above cases due to large variations in particle size and dose.

A specific example will be described. Among patients with diabetes that are currently on the rise, patients with insulin-dependent diabetes called type I do not secrete insulin from the pancreas, and therefore need to regularly administer insulin. Since insulin is currently administered by subcutaneous injection, the physical and mental burden on the patient is great. In order to reduce the burden on the patient, a pen-type syringe that has a thin needle and does not feel much pain has been developed. However, patients with type I diabetes often work in the same way as healthy people except that they need to administer insulin on a regular basis. This makes it difficult to administer at an appropriate time.

In such cases, in order to facilitate administration by the patient himself / herself, there is a need for an easy method for dispensing the drug from the lung by ejecting the drug as a droplet instead of an injection to ensure that it reaches the lung together with inhalation. It is.

Therefore, recently, a physiologically effective drug is appropriately discharged from the discharge orifice into the air flow sucked from the mouthpiece or the like by the force of the bubble jet (registered trademark) or the piezoelectric element provided in the discharge head section (discharge section). A method of discharging a predetermined number of small droplets has been devised (see Patent Document 1 and Patent Document 2).
International Publication WO95 / 01137 International Publication WO02 / 04043

In these apparatuses, it is possible to make the particle size of the ejected droplets uniform. However, since a negative pressure, which is a pressure difference from the atmospheric pressure generated at the time of inhalation, is directly applied to the discharge head portion, there is a possibility of causing liquid leakage from the orifice at the time of inhalation. When a liquid leak occurs, the droplet does not become an appropriate droplet, and the ejection from the blocked orifice is not performed, so that a predetermined amount of ejection is not performed. In addition, since negative pressure is directly applied to the discharge head portion, there is a problem that affects the life of the discharge head portion, and the actual situation is that it is not practical.

In view of the above problems, the inhaler of the present invention has a mouth portion and an outside air intake, and a flow path for forming an air flow from the outside air intake to the mouth by a user's inhalation, Provided outside the flow path in communication with a liquid agent discharge section provided in the flow path and having a discharge port for discharging the liquid agent into the flow path, and a hole (13) provided in the flow path. A pressure detection unit for detecting a negative pressure generated in the flow path at the time of inhalation by a user, and inhaling from the mouthpiece by the user in response to a detection result by the pressure detection unit In the suction device for discharging the liquid agent, a pressure relaxation means (4a) for relaxing negative pressure generated in the discharge port is provided on the suction port side of the liquid agent discharge portion in the flow path. And a hole (13) provided in the flow path Is provided on the suction port side from the pressure relaxation means, and has an enlarged space (22) in the middle of a flow path communicating the hole (13) and the pressure detection unit. And

Further, in view of the above problems, the mouthpiece of the present invention is a mouthpiece that can be attached to and detached from the inhaler, and constitutes a flow path that forms an air flow between the mouthpiece and the outside air intake, A portion having pressure relief means for relieving negative pressure in the discharge part in the middle of the flow path, and a portion where the pressure detection part is arranged on the suction side from the pressure relief means (for example, a negative pressure sensor described later) And a portion (for example, a liquid agent intake port, which will be described later) in which the discharge port of the liquid agent discharge unit is disposed closer to the outside air intake side than the pressure relaxing means.

According to the present invention, the pressure relief means for relieving the negative pressure generated at the discharge port is provided on the suction port side of the flow path from the liquid agent discharge portion, so that the possibility of liquid leakage from the discharge portion is low. As a result, the adverse effect on the life of the discharge unit is reduced.

An embodiment of the present invention will be described. In one embodiment of the inhaler or inhaler of the present invention, the storage device is configured to be carried and carried by the user, and stores information relating to the individual user including information on the user's medical record and prescription. The liquid agent can be quantitatively discharged as fine droplets with high uniformity in particle size, and inhaled by the user. In order to allow the user to efficiently and hygienically inhale the liquid according to the prescription information, the user has a mouthpiece having a mouthpiece portion for inhaling and a tank for storing the liquid at the time of use. A discharge head cartridge (CRG) unit that discharges the liquid agent supplied from as droplets can be mounted on the inhaler body.

In addition, the flow path that forms the air flow of the entire inhaler is formed only by the mouthpiece, and a throttle portion that is a pressure relief means is provided in the middle of the mouthpiece, and the user side (ie, the mouthpiece side) from the throttle portion ), A pressure detection unit having a pressure detection function is arranged, and a discharge unit of the CRG unit is arranged on the outside air intake side from the throttle unit. When a negative pressure of a certain level or more (for example, −0.3 kPa or more (absolute value of 0.3 or more)) is applied to the ejection head unit, the liquid agent flows out from the ejection port, blocks the ejection port, and thereafter The liquid agent is not discharged well. Therefore, by providing the throttle portion, the discharge port does not directly receive the negative pressure generated by the user's inhalation, and the fine droplets can be discharged from the discharge port of the discharge head portion continuously and satisfactorily. In this way, the discharge port of the discharge unit is configured to be disposed at a position that causes a pressure difference that does not naturally discharge the liquid agent from the discharge port due to a negative pressure that is a pressure difference from the atmospheric pressure generated during inhalation, The liquid droplet can be discharged well. As a discharge method in the discharge unit, either thermal energy (method using an electrothermal transducer) or piezoelectric energy (method using a piezoelectric element) may be used. In any method, since the liquid is supplied from the tank opened to the atmosphere by the capillary force of the nozzle, a pressure environment in a range where the (negative) pressure and the outlet meniscus by the tank can be balanced is necessary.

As shown in FIG. 8, the pressure detection unit detects a certain negative pressure and starts to discharge from the discharge port. The minimum negative pressure detected by the pressure detection unit is generated in the pressure detection unit depending on the amount of suction. There are individual differences in negative pressure, and it is generally related to vital capacity, so it needs to be set appropriately. Therefore, considering the use of children and elderly people with low vital capacity, the throttle section cross-sectional area should be set to about 10 mm ² so that the negative pressure is −0.5 kPa or more (0.5 or more in absolute value). As a result, a negative pressure change (inhalation curve shown in FIG. 8) generated by inhalation can be accurately measured by the pressure detection unit. Depending on the user's vital capacity, the throttle area may be changed to facilitate inhalation. For example, for a person with a large vital capacity, the throttle area may be increased.

Here, the airflow of the entire inhaler is formed only by the mouthpiece, so that the dirt of the airflow part due to the liquid becomes only the flow path in the mouthpiece, and if only the mouthpiece is washed, the inside of the inhaler Is kept safe and hygienic.

Further, when the liquid agent is discharged in the inhaler, parameters (discharge speed, discharge time, etc.) relating to the discharge of the liquid agent are changed, for example, in accordance with the amount of inhalation (that is, detected by the pressure detection unit). The inhalation efficiency can be improved by feeding more liquid preparation to the user's lungs by changing the inhalation curve according to the degree of change of the inhalation curve shown in FIG. As described above, when the user has a discharge control means for changing a parameter related to the discharge of the liquid agent in accordance with a change in the flow rate of suction (negative pressure change) obtained from the negative pressure sensor within a predetermined time during which the user performs the suction. There may be provided means for notifying the re-inhalation when the predetermined inhalation cannot be performed within a predetermined time when the person performs the inhalation. Such an embodiment attaches importance to ease of use and eliminates troublesome operations as much as possible, and can be easily used by anyone anywhere.

The following configuration can also be adopted.
As the pressure relaxation means, it is possible to use a valve that always closes the flow path forming the air flow but opens at the time of inhalation, and a pressure detection part is arranged on the suction side from this valve, and the discharge part on the opposite side. A discharge port is arranged. The valve that has been closed until then begins to open by suction, so the negative pressure reaches the discharge port of the discharge part on the opposite side of the suction part with the valve slightly delayed and relaxed. It will function as a pressure relaxation means.

The discharge port of the pressure detection unit and the discharge unit may be arranged so as to face separate flow paths from the suction port unit. In this case, the flow channel forms a flow channel outlet at the suction port, and the suction port has a portion that is formed around the flow channel outlet in accordance with the shape of the human mouth and forms another flow channel. And the part (communication hole with a negative pressure sensor) by which a pressure detection part is arrange | position faces the said another flow path.

In addition, a negative pressure sensor is used to monitor the inhalation amount (that is, the inhalation curve shown in FIG. 8 is monitored), and whether the inhalation amount is an appropriate value is indicated to the user by blinking the LED, vibration of the vibration motor Means for informing by a change of the aspect may be provided. Further, there may be provided means for informing the user of the inhalation time for starting the inhalation and how long it should be inhaled. As means for notifying the inhalation time, means utilizing vibration of a vibration motor can be used.

With the inhaler configured as described above, the mental and physical burden on the patient (user) can be reduced, and the inhalation of the medicine (solution) can be performed by a simple operation of the patient, and the medicine is accurately discharged and managed according to the prescription. At the same time, by changing the ejection drive parameter in accordance with the inhalation amount of the patient, there is an effect of sending more medicine to the lungs to improve the inhalation efficiency and efficiently administering the medicine.

Hereinafter, embodiments of the present invention will be described in detail with reference to the drawings.

[Example 1]
FIG. 1 is a perspective view showing an appearance of an inhaler. Reference numeral 1 denotes an inhaler body, 2 an access cover, and 3 a front cover, which form a housing. Reference numeral 5 denotes a lock lever, and a claw-shaped portion provided at the tip of the lock lever 5 biased by a spring is caught on the protrusion 2a provided at the tip of the access cover 2 so that the access cover 2 does not open during use. It is formed to have. When the lock lever 5 is slid downward, the access cover 2 opens about a hinge shaft (not shown) as a rotation center by the force of an access cover return spring (not shown) that biases the access cover 2. Reference numeral 101 denotes a power switch, and reference numeral 102 denotes a display LED for displaying whether a discharge head cartridge (CRG) unit or mouthpiece, which will be described later, is not installed, or whether the liquid in the tank of the CRG unit is empty. belongs to.

FIG. 2 illustrates a state where the access cover 2 is opened. When the access cover 2 is opened, the CRG unit 6 and the mouthpiece 4 mounted in the housing along the CRG guide 20 can be seen. The mouthpiece 4 is under the CRG unit 6 and these are mounted in a crossing manner. The entire CRG unit 6 is shown in FIG. The CRG unit 6 includes a tank 7 containing a liquid agent, a head portion (discharge portion) 8 that discharges the liquid agent, and electric power for generating thermal energy in a heater that is an electrothermal converter provided in the head portion 8. It is comprised from the part (electrical connection part) 9 etc. which have the electrical connection surface for supplying from FIG. The battery 10 can be charged as a secondary battery that retains electric power for generating heat energy in the heater inside the inhaler. The front portion of the CRG unit 6 can be opened around the hinge portion 24 and can access the tank 7. For example, a projection is formed on the rear surface of the front portion, and at the same time the front portion is closed, the projection enters the tank 7 and applies a slight pressure to the liquid in the tank 7 to refresh the discharge port of the head portion 8. It is supposed to do.

Cross-sectional views of the mouthpiece 4 are shown in FIGS. The mouthpiece 4 forms an air flow path with the mouthpiece 4 alone, and a liquid agent is introduced into the mouthpiece 4 from a discharge port provided in the head portion 8 of the CRG unit 6 in a portion near the air intake port 11. An intake window (liquid supply inlet) 12 is opened. In the middle of the mouthpiece 4, a throttle portion 4 a having a shape that gradually changes in the direction in which the cross-sectional area decreases is formed. As shown in detail in FIG. 6, a negative pressure for detecting a negative pressure to detect a suction speed or a flow rate as an integral value thereof is detected in a portion where the cross-sectional area is widened from the throttle portion 4 a having a reduced cross-sectional area. A hole 13 communicating with the measurement hole of the sensor 19 is provided. The negative pressure sensor 19 is disposed on the control board 21 (see FIGS. 6 and 7). In the middle of the flow path communicating from the air hole 13 to the negative pressure sensor 19, an expanded space 22 is provided. This is provided as a reservoir for dirt, dirt, water droplets, liquid agent, etc., and prevents these from entering through the air holes 13 and adhering to the surface of the negative pressure sensor 19 to cause malfunction.

At the opposite end of the air intake port 11, a mouthpiece outlet (suction port) 15 is formed that has a shape that makes a person feel. The mouthpiece outlet 15 has an elliptical cross section in accordance with the shape of the mouth of the person, and a flow path outlet 14 serving as a passage for the liquid agent is provided inside the double structure. The cross-sectional area of the channel outlet 14 gradually increased so that the mixed fluid of air and liquid suddenly spreads at the outlet and the mixed fluid does not adhere to the teeth of the mouth of the person holding the mouthpiece outlet 15. It has a shape. Therefore, when the user grips the mouthpiece outlet 15, the end of the channel outlet 14 may be slightly in the teeth. In order to facilitate this, the end of the channel outlet 14 may be formed slightly outside the end of the mouthpiece outlet 15. Moreover, as shown in FIGS. 1 and 2, the cross section of the air flow path of the mouthpiece 4 has a quadrangular shape, and the air intake 11 faces upward when the mouthpiece 4 is mounted in the housing. It is designed to be securely attached in the state.

In FIG. 7, the whole longitudinal cross-sectional view of the inhalation device of a present Example is shown. A control board 21 for controlling the inhaler is disposed under the battery 10. A probe board 16 connected to the control board 21 by a cable or a connector (using a connector 25 in FIG. 7) is disposed under the CRG unit 6, and the electrical connection portion 9 of the CRG unit 6 is connected to the probe board 16. Therefore, a contact probe 17 for energizing the head 8 of the CRG unit 6 for heat generation is provided. A vibration motor 18 is disposed in the space between the battery 10 and the mouthpiece 4 so as to be in contact with the control board 21.

The inhalation operation of the present embodiment having the above configuration will be described with reference to FIG.
When the user's inhalation is started and the negative pressure (related to the suction speed or flow rate) detected by the negative pressure sensor 19 reaches a dischargeable region, the head portion 8 of the CRG unit 6 is controlled by the control board 21. Then, the discharge of the liquid agent is started, and at the same time, the vibration of the vibration motor 18 is started to inform the user that the discharge of the liquid agent has started. Based on the inhalation speed and the inhalation duration calculated from the negative pressure measurement value of the negative pressure sensor 19 so that the last ejected liquid agent reaches the lung after the discharge of the predetermined amount of liquid agent from the head unit 8 is completed. The vibration motor 18 vibrates for the preliminary inhalation time after the end of the ejection to inhale the preliminary inhalation, and prompts the user to inhale so that the ejected liquid completely reaches the lungs. When the vibration of the vibration motor 18 ends, the user or patient stops inhalation. According to this, the ejection of the liquid agent and the inhalation are interlocked, so that the liquid agent can be surely sent to the lung, and there is no failure such as insufficient inhalation.

In this way, by the user's inhalation operation, air enters the mouthpiece 4 from the air intake port 11 and becomes a liquid agent and a mixed fluid discharged from the discharge port provided in the head portion 8 of the CRG unit 6. It heads for the mouthpiece outlet 15 which has the shape to be able to do. The mouthpiece outlet 13 prevents leakage of the mixed fluid from the side of the mouth, reduces inhalation waste, makes the mixed fluid difficult to collide with obstacles such as teeth in the mouth, and the liquid agent is efficient. Inhaled into the user's body.

In this embodiment, the patient or user dislikes being known to the people around him and the annoyance to the people around him, so that vibration using the vibration motor 18 is preferred over sound notification. A vibration motor is provided. Thereby, inhalation can be easily performed anywhere.

An example of the overall operation of the inhaler will be described with reference to the flowchart of FIG. When the power switch 101 is turned on, the opening / closing of the access cover 2 is detected (S801), and if it is opened, a warning is issued by the display LED 102 or the like. If closed, it is next detected whether or not the CRG unit 6 is attached (S802). In this example, when not worn, Bluetooth communication is started (S803), and data such as a prescription amount related to the user is transmitted / received (S804). When the communication is completed (S805), the operation is completed. This mode is mainly used by user doctors.

When the CRG unit 6 is mounted, the operation is as follows. This mode is usually used by patients or users. When the user starts inhaling (S806) and this inhalation is detected and a certain negative pressure is detected by the negative pressure sensor 19 (S807), the ejection head unit 8 starts ejecting liquid droplets (S808). When a constant negative pressure is not detected, a warning that encourages stronger inhalation may be issued.

The liquid discharge is continued for a predetermined time from the start time, and a predetermined amount of liquid is discharged. This amount is determined from the read data. After that, the negative pressure sensor 19 monitors the temporal change of the negative pressure due to inhalation, and whether or not a predetermined amount has been inhaled from the integral amount (which time point should be determined appropriately) (Since this integral amount is related to the inhalation amount of the gas mixture of the user's air and liquid agent, it corresponds to detecting the inhalation of the predetermined amount of liquid agent) (S809) finish. During this time, the vibration motor 18 is vibrated. If a predetermined amount of liquid inhalation cannot be detected even after a predetermined time has elapsed, a warning is issued to the user due to a change in the vibration mode of the vibration motor 18 and the like, prompting re-inhalation (S806). At this time, the amount of insufficient suction is calculated (S810), and the amount of liquid droplet discharged by the discharge head unit 8, the suction time (that is, the vibration time of the vibration motor 18) and the like are set accordingly.

According to the embodiment described above, the discharge port of the liquid agent discharge unit is reliably arranged at a position where a pressure difference smaller than the pressure difference from the atmospheric pressure detected by the pressure detection unit at the time of inhalation is generated. The possibility of causing liquid leakage is reduced, and the adverse effect on the life of the discharge unit is reduced. And a predetermined amount of a liquid agent can be reliably and efficiently administered to a user with a simple operation.

[Example 2]
FIG. 10 shows Example 2 that differs from Example 1 only in the configuration of the flow path to the pressure detection unit (the communication hole 13 with the negative pressure sensor 19). In the second embodiment, the communication hole 13 is provided outside the flow channel outlet 14 of the mouthpiece outlet 15 at the distal end of the mouthpiece 4, whereby the negative pressure detection flow channel to the negative pressure sensor 19 is provided as a mouthpiece. The four air flow paths are completely separated and arranged in parallel. When the mounting method is employed in which the mouthpiece 4 is inserted from above and in front of the inhaler, the mounting direction is the direction in which the communication hole 13 is in close contact with the negative pressure detection flow path to the negative pressure sensor 19, thus preventing air leakage. Is advantageous. Therefore, negative pressure detection is reliably performed. Further, since the negative pressure detection flow path to the negative pressure sensor 19 and the liquid agent flow path are completely separated, contamination by the liquid agent in the negative pressure detection flow path is reduced, and accurate detection is ensured. The The other points are the same as in the first embodiment.

[Example 3]
FIG. 11 shows a third embodiment provided with a pressure relaxing means different from the flow path restricting method of the first embodiment. In the third embodiment, in the flow path of the mouthpiece 4, the portion between the communication hole 13 to the negative pressure sensor 19 and the liquid agent inlet 12 where the discharge head unit 8 comes is approximately the same size as the cross-sectional area of the flow path. The valve 30 is rotatably provided. The valve 30 is in a state shown in FIG. 11 (a), which always hits the valve stopper 31 and closes the flow path except during inhalation. When the user inhales, the valve 30 opens as shown in FIG. 11 (b). At this time, a relatively strong negative pressure is generated in the flow path space on the negative pressure sensor 19 side. Not so much negative pressure is generated in the channel space. Therefore, the same effect as Example 1 is produced. The other points are the same as in the first embodiment.

It is a perspective view of an example of the inhaler or inhaler of the present invention. FIG. 2 is a perspective view showing a state where an access cover is opened in FIG. 1. It is a perspective view of an example of a CRG unit. It is side surface sectional drawing of an example of a mouthpiece. It is front direction sectional drawing of the mouthpiece of FIG. FIG. 5 is a side sectional view showing an arrangement relationship of the mouthpiece, the negative pressure sensor, and the discharge head portion of the CRG unit of FIG. FIG. 2 is an overall cross-sectional view of the inhaler or inhaler of FIG. 1. It is a graph explaining the inhalation operation example of the inhaler or inhaler of FIG. 2 is a flowchart for explaining the overall operation of the inhaler or inhaler of FIG. It is sectional drawing of the structure of the mouthpiece vicinity of Example 2 of a flow path parallel type. It is a figure explaining operation | movement of Example 3 using a valve.

Explanation of symbols

1 Inhaler body 4 Mouthpiece 4a, 30, 31 Pressure relaxation means (throttle part, valve)
6 Discharge head cartridge (CRG) unit 8 Discharge head section (discharge section)
11 Outside air (air) intake port 12 Portion where the discharge port of the liquid agent discharge part is arranged (liquid agent intake port)
13 The part where the pressure detection part is arranged (the communication hole to the negative pressure sensor)
15 Mouthpiece outlet (mouth)
19 Negative pressure sensor (pressure detector)

Claims (3)

A flow path for forming an air flow from the outside air intake port to the suction port by inhalation of a user, having a suction port portion and an outside air intake port;
Provided in the flow path, a liquid discharge portion having a discharge port for discharging the liquid in the flow path,
A pressure detection unit that communicates with a hole (13) provided in the flow path and is provided outside the flow path to detect a negative pressure generated in the flow path when inhaled by a user. And
In response to a detection result by the pressure detection unit, an inhaler that discharges the liquid that is inhaled by the user from the mouthpiece,
A pressure relaxation means (4a) is provided on the suction port side of the liquid agent discharge portion in the flow path to relieve a negative pressure generated in the discharge port,
The hole (13) provided in the flow path is provided on the suction port side from the pressure relaxing means, and an enlarged space is provided in the middle of the flow path connecting the hole (13) and the pressure detection unit. (22) Inhalation device characterized by having . 2. The inhaler according to claim 1 , wherein the pressure relaxing means is a throttle portion in which a cross-sectional area of the flow path forming the air flow is reduced. The liquid discharge portion, the suction device according to claim 1 or 2, wherein the further comprising electrothermal transducers or piezoelectric elements for generating energy for discharging the liquid.

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