JP2006212088A - Inhaler - Google Patents

Abstract

<P>PROBLEM TO BE SOLVED: To provide an inhaler having a sensing means for sensing or measuring the inclination of an enclosure which allows a patient to inhale a medicine efficiently with an easy operation by reducing mental and physical burdens of the patient when the medicine is inhaled using the inhaler. <P>SOLUTION: The inhaler is used by a user for inhaling a liquid medical agent via its inhalation port. The inhaler has the sensing means for detecting or measuring the inclination of the enclosure with respect to an inclination reference. The inhaler may further has either or both of a notice means connected to the sensing means for giving a notice to the user on the basis of information from the sensing means and/or a control means connected to the sensing means for controlling a discharge of the liquid medical agent on the basis of the information from the sensing means. The inhaler may further has a memory means for storing the information from the sensing means. <P>COPYRIGHT: (C)2006,JPO&NCIPI

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 heater element or a piezoelectric element provided in the discharge head section (discharge section) imparts discharge energy to the liquid containing the drug, and a physiologically effective drug is introduced into the air flow sucked from the mouthpiece or the like. A method of discharging a predetermined number of appropriate droplets from the discharge orifice has been devised (see Patent Document 1 and Patent Document 2).
International Publication WO95 / 01137 International Publication WO02 / 04043

However, the conventional example includes a method in which the particle size and the discharge amount of the droplets to be discharged vary depending on the posture of the inhaler. The particle size of the droplets affects the probability of reaching the alveoli, and the change in the discharge amount affects the appropriate amount administration, which may cause inability to inhale the correct dose prescribed by the doctor.

In view of the above problems, an inhaler according to the present invention is an inhaler for a user to inhale a liquid medicine from a mouthpiece, and has a detecting means for detecting or measuring the inclination of the casing from an inclination reference. It is characterized by that. In the present invention, there is provided a notification means (such as a vibration motor described later) connected to the detection means for notifying the user based on information from the detection means, or discharging the liquid agent based on information from the detection means. Control means (such as a control circuit to be described later) that performs control relating to the above, or both of them, or storage means (such as a memory that will be described later) for storing information from the detection means. .

As the detection means, for example, an acceleration sensor can be used. Using an acceleration sensor as means for detecting this tilt is an effective method because the direction of gravity G in the environment where the apparatus is used is the vertical direction.

According to the present invention described above, since it has detection means for detecting or measuring the inclination of the housing from the inclination reference, for example, when the inhaler is used as a medicine inhaler, the mental state of the patient, The physical burden is reduced, and the drug can be efficiently inhaled by simple operation of the patient. That is, depending on how the patient is held, for example, by changing the ejection drive parameters (applied voltage to the ejection head, pulse width, particle size, ejection amount, ejection time, etc.) and also informing the patient As a result, the inhalation efficiency is improved by sending more drugs to the lungs, and the drugs are effectively administered. Furthermore, the inclination detection result can be used for various purposes.

Hereinafter, in order to clarify the embodiment of the present invention, specific examples will be described in detail with reference to FIGS.

[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 120 denotes a power switch, and 104 denotes a display LED for displaying whether a discharge head cartridge (CRG) unit or a mouthpiece, which will be described later, is not installed, or that the liquid in the tank of the cartridge unit is empty. belongs to. The display LED 104 will be further described later.

FIG. 2 illustrates a state where the access cover 2 is opened. When the access cover 2 is opened, the cartridge unit 6 and the mouthpiece 4 mounted in the housing along the cartridge guide 20 can be seen. The mouthpiece 4 is under the cartridge unit 6 and these are mounted in a crossing manner. The entire cartridge unit 6 is shown in FIG. The cartridge unit 6 includes a tank 7 containing a liquid agent, a head portion (discharge portion) 8 that discharges the liquid agent, and a battery 10 (FIG. 7) that applies heat energy to generate bubbles in a heater provided in the head portion 8. It comprises a part (electric connection part) 9 etc. having an electric connection surface for supplying from (see). The configuration of the head portion is not limited to this, and a configuration in which a piezoelectric element is provided in place of the heater may be used. Furthermore, a droplet is formed by applying vibration energy to a mesh structure film having a large number of holes. The structure which forms may be sufficient. The battery 10 can be recharged as a secondary battery holding electric power for applying energy to such a heater or the like inside the inhaler. The front surface portion of the cartridge 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 only with the mouthpiece 4, and a liquid agent is introduced into the mouthpiece 4 from a discharge port provided in the head portion 8 of the cartridge 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 (connector 25 in FIG. 7) is disposed under the cartridge unit 6, and the electrical connection portion 9 of the cartridge unit 6 is connected to the probe board 16. Therefore, a contact probe 17 for energizing the head unit 8 of the cartridge unit 6 for generating heat 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. FIG. 8 shows the relationship between the inhalation curve in breathing and the discharge period. 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 cartridge unit 6 is controlled by the control substrate 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 cartridge 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.

FIG. 9 shows a modification in which only the configuration of the flow path to the pressure detection unit (the communication hole 13 with the negative pressure sensor 19) is different. In this modification, the communication hole 13 is provided outside the flow path outlet 14 of the mouthpiece outlet 15 at the distal end of the mouthpiece 4, whereby the negative pressure detection flow path 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

FIG. 10 shows an overall block diagram around the control board 21 of the present apparatus. In FIG. 10, reference numeral 101 denotes a CPU which is an arithmetic processing unit, and has a built-in flash ROM storing a program. An SRAM 102 is a readable / writable memory for temporarily storing data when the program operates. Reference numeral 104 denotes the above-described LED which is a display device for notifying the user of the state of the device to a user, a maintenance worker, and the like. Reference numeral 105 denotes a wireless unit that manages wireless communication for transferring the status and stored contents of the apparatus to the host and receiving data from the host. Reference numeral 106 denotes an antenna for the wireless unit. Reference numeral 107 denotes a cover sensor for detecting the open / closed state of the access cover 2. Reference numeral 108 denotes an amplifier that converts and amplifies the output of the negative pressure sensor 19, and reference numeral 109 denotes an AD converter that converts an analog output of the amplifier 108 into a digital signal. Reference numeral 110 denotes a driver that controls the head unit 8. 111 is an RTC (real
112 is a backup battery for the RTC 111. A power source 113 generates various voltages to be supplied to the electric circuit, and includes a main battery, a charging circuit, a reset circuit, the power switch 120, and the like.

Reference numeral 114 denotes a sensor that detects the inclination of the machine, which is a characteristic part of the present invention. Reference numeral 115 denotes a detection circuit that processes the output of the sensor 114. Reference numeral 116 denotes an analog signal that is the output of the detection circuit 115. It is an AD converter that converts to The sensor 114 is attached in a predetermined posture in an appropriate space in the inhaler body. Reference numeral 117 denotes a control circuit that processes output or input signals for various blocks and is connected to the CPU 101 via a bus. A USB port connected to the CPU 101 is also provided as an external interface.

As the sensor 114 for detecting the tilt, various tilt sensors and acceleration sensors can be used, and an appropriate sensor may be employed according to the specifications of the inhaler. As an acceleration sensor, for example, a plurality of pairs of electrostatic capacitance elements that are arranged to be opposed to each other are provided by mounting electrodes on opposing surfaces of a fixed substrate made of glass or the like and a flexible substrate made of silicon or the like. Capacitance-type acceleration sensor configured to detect changes in acceleration in the X, Y, and Z-axis direction components based on capacitance changes between capacitive elements, around the weight when acceleration acts on the weight There is a piezoelectric three-axis acceleration sensor configured to bend at a portion of the piezoelectric ceramic substrate. Three-axis acceleration sensors are available from various companies, such as HAAM301 (trade name) manufactured by Hokuriku Electric Industry, ML8950 (trade name) manufactured by Oki Electric Industry, and the like.

The reference of the inclination of the apparatus when detecting the inclination is, for example, an inclination attitude of the apparatus in which the discharge direction of the discharge head is the horizontal direction, an inclination attitude of the apparatus that is also downward in the vertical line direction, and a certain angle from the vertical line direction. For example, the tilting posture of the device. The inclination reference may be determined in consideration of the characteristics and performance of the discharge head and the use of the inclination detection result.

In the above configuration, when the power switch 120 is operated, the power supply 113 outputs a reset signal to the CPU 101, and the CPU 101 is initialized by the signal and operates according to a program stored in the internal flash ROM. For the first time, if no special setting is made, the operation starts as a normal operation mode. When the user inhales, the output of the negative pressure sensor 19 changes, and the change is transmitted to the CPU 101 via the amplifier 108, the AD converter 109, and the control circuit 117. When the inhalation amount exceeds a predetermined threshold, the CPU 101 applies a voltage to the vibration motor 18 to vibrate it, and sends a pulse signal or the like to the head unit 8 via the control circuit 117 and the driver 110, whereby the cartridge The liquid agent contained in the unit 6 is discharged. Even after discharging for a specified time, the vibration motor 18 continues to vibrate for a specified time and prompts the user to inhale during that time.

In this series of operations, the CPU 101 sequentially monitors the information of the sensor 114. For example, when the tilt information exceeds a certain threshold value, the control to the head unit 8 is changed via the control circuit 117 (for example, , Change applied voltage, pulse width, etc.). Thereby, for example, the particle size of the droplets ejected by the head unit 8 is controlled. For example, when the inclination further exceeds the second threshold value, the CPU 101 changes the vibration pattern of the vibration motor 18 and instructs the user not to tilt further. FIG. 11 shows the vibration pattern when it is normal and when the second threshold is exceeded. In the former, the vibration is continuously performed, and in the latter, the vibration is interrupted. At this time, when the state where the inclination exceeds the second threshold value continues for a certain period of time, control may be performed so as to stop the discharge of the liquid droplets.

As described above, any sensor 114 can be used, but some of these sensors include a detection circuit and an AD converter. In this case, the sensor 114 is not connected to the detection circuit 115 or the AD converter 116. It can be directly connected to the control circuit 117 or the CPU 101. FIG. 12 illustrates an example of control when the inclination exceeds a threshold value. During normal times, the driver drives the head 8a for normal posture. When the tilt exceeds the threshold, the tilt head 8b is driven. The head 8a for normal posture and the head 8b for tilt are made, for example, in structures having different discharge particle diameters (in this case, both heads may be mounted side by side in the same posture). As another example, there is a method in which the head 8a for normal posture and the head 8b for tilting are the same and are arranged with different tilts. Further, as described above, there is also a method of changing the particle size, amount, etc. of the ejection by changing the drive pulse for one head.

As described above, various countermeasures such as changing the discharge mode, stopping the discharge, and notifying the user are possible according to the detection of the inclination of the inhaler, and the combination is appropriately designed depending on the case. do it. Furthermore, the detection information of the inclination of the inhaler can be used for the following purposes, instead of being used for controlling the ejection head. That is, the inclination of the usage state of the apparatus can be stored in a memory and used later by a doctor or the like to check the usage state history. In such a case, for example, an appropriate determination based on the usage history (e.g., paying attention to the patient's usage, estimating the patient's physical condition, knowing whether the patient is sleeping or inhaling standing, It is possible to use a material or the like that adjusts the discharge amount or the like and replaces the discharge head with another one.

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 cartridge (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 cross-sectional view showing the positional relationship among the mouthpiece, negative pressure sensor, and ejection head portion of the cartridge unit of FIG. 4. It is whole sectional drawing of the inhalation device of FIG. It is a graph explaining the example of inhalation operation | movement of the inhaler of FIG. It is sectional drawing of the structure of the mouthpiece vicinity of a flow path parallel type. It is a block diagram of an example of the inhalation device of the present invention. It is a figure which shows the vibration pattern of the vibration motor of an example of the inhaler of this invention. It is a block diagram of the head driver of an example of the inhalation device of the present invention.

Explanation of symbols

1 Inhaler body (housing)
4 Mouthpiece 6 Discharge head cartridge (CRG) unit 8 Discharge head section (discharge section)
11 Outside air (air) intake 12 Portion where the discharge port of the liquid agent discharge part is arranged (liquid agent intake)
15 Mouthpiece outlet (mouth)
18 Vibration motor (notification means)
19 Negative pressure sensor 114 Sensor for detecting inclination (detection means)
117 Control circuit (control means)

Claims (6)

An inhaler for inhaling a liquid from a mouthpiece by a user, the inhaler having a detecting means for detecting or measuring an inclination of the casing from an inclination reference. The inhaler according to claim 1, further comprising a notification unit connected to the detection unit and configured to notify the user based on information from the detection unit. 2. The inhaler according to claim 1, further comprising a control unit connected to the detection unit and configured to control the discharge of the liquid agent based on information from the detection unit. A notifying means connected to the detecting means for notifying a user based on information from the detecting means, and a control means connected to the detecting means for controlling the discharge of the liquid agent based on the information from the detecting means. The inhaler according to claim 1, comprising: The inhaler according to claim 1, further comprising a storage unit connected to the detection unit and storing information from the detection unit. The inhaler according to any one of claims 1 to 5, wherein an acceleration sensor is used as the detection means.

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