JP4455626B2 - Drug delivery device - Google Patents

Description

The present invention relates to a liquid agent discharge device such as a pulmonary suction type drug discharge device used by a user for inhaling a liquid droplet of a liquid agent such as a drug, and in particular, configured to stably perform normal discharge of the liquid agent. It is related with the liquid agent discharge apparatus made.

In recent years, a telemedicine system and a home health management system have been proposed that can perform medical examinations and daily health management without going to hospital for elderly people or patients with lifestyle-related diseases or chronic diseases.

The typical configuration of these systems is that the target individual installs a terminal at home, etc., connects to a server in a medical institution or center via a communication line such as the Internet, and answers to an inquiry, blood pressure, Measurement values such as body temperature are input and transmitted, and nurses and doctors check the data collected in the server, and return the presence or absence of an abnormality and a message.

In order to operate such a medical system, an electronic medical record for electronically recording each user's medical record (medical chart) and a medical database for storing electronic medical record data and various measurement values are required.

Further, to achieve a medical at home, the device appropriate medication administered to the patient based on the data written in the electronic medical record is made and is indispensable now ejecting drug as fine droplets, the user Development of portable drug delivery devices that inhale from the lungs is underway. This device also has a function as a portable terminal capable of receiving medical information such as an electronic medical record, and enables accurate drug prescription by the user.

Using such a drug delivery device, users can take drugs in a way that is much easier than injections with a large mental load, and can make optimal prescriptions by utilizing information databases such as electronic medical records. Become.

For this purpose, the medicine ejection device ejects the medicine at an appropriate timing according to the inhalation profile of the user and efficiently flows it into the lung, or appropriately controls the total amount of minute medicine particles to be ejected, It is assumed that the dose can be managed. As such an apparatus, a liquid agent discharge apparatus (dispenser) using liquid ejecting means used in an ink jet recording apparatus is known (see Patent Document 1).
JP-T 8-511966

The above-mentioned medicine ejection device performs appropriate ejection control according to the inhalation profile of each user and can manage the dosage of the medicine and efficiently administer the medicine, but the medicine ejection is performed normally. If not, the reliability of the discharge state of the drug particles is impaired.

For example, in order to inhale and take a medicine from the lung, it is necessary to reduce the size of the medicine particles to be discharged to about 10 microns or less, and the medicine outlet is inevitably small. Since the medicine discharge port is in direct contact with the outside air, it may be caused by sticking of the medicine due to drying, adhesion of foreign substances brought in from the outside, etc. It is a place with the danger of causing Making the medicine discharge port smaller increases the probability of causing clogging, and affects the discharge sensitively to foreign matter adhesion.

When the ejection abnormality is caused, the dose that the drug prescription system is scheduled to differ from the actually administered dose. As a result, an error occurs between the history of drug administration recognized by the system and the actual history, and normal prescription management cannot be performed. This is an obstacle to the effective use of the original database.

Further, if germs brought in from the outside of the apparatus adhere to the vicinity of the discharge port, the user may inhale it together with the medicine. Therefore, the installation surface of the discharge port needs to be kept clean.

The present invention has been made in view of the above situation, and provides a liquid agent discharge apparatus such as a drug discharge apparatus with high operation reliability that enables appropriate liquid agent discharge with a relatively simple configuration. It is aimed.

A medicine ejection device according to the present invention that achieves the above object is a medicine ejection device that ejects a medicine for inhalation by a user, the medicine containing tank for containing the medicine, and the ejection for discharging the medicine. has a holder for accommodating the head therein, to cut off the interior of the holder from the outside air, the outside air shielding member for protecting the cap to protect the discharge ports of the ejection head for ejecting the drug, the The cap is formed integrally with the outside air shielding member, and the inside of the holder can be protected by the outside air shielding member, and the discharge head can be protected by the cap .

As described above in detail, according to the liquid agent discharge apparatus of the present invention, the outside air shielding member for blocking and protecting the inside of the holder from the outside air and the discharge port of the discharge head for discharging the medicine are protected. The cap is integrally formed, and the inside of the holder is protected by the outside air shielding member, and the discharge head is protected by the cap. Therefore, it is possible to realize a medicine ejection device with high operation reliability that enables appropriate liquid medicine ejection with a relatively simple configuration.

Embodiments of a liquid agent discharge device such as a medicine discharge device of the present invention will be described in detail below with specific examples.

[First embodiment]
FIG. 1 and FIG. 2 are perspective views showing a drug injecting device for lung inhalation that is a first embodiment of the present invention, and FIGS. 1 (a) and 1 (b) show a standby state, FIG. 1 (c) shows a state where inhalation is performed. FIG. 2 (a) shows the internal structure of the medicine ejection device, and FIG. 2 (b) shows the exchange of the internal member. FIG. 3 shows a state where inhalation is performed according to a modification of the present embodiment. In order to express the structure in an easy-to-understand manner, a perspective expression is partially used in these drawings and is indicated by a broken line.

The left end of FIG. 1 (a) and FIG. 1 (c) is a medicine inhalation port, and the user inserts the mouthpiece 4 into the mouth to inhale the medicine. The mouthpiece 4 can be cleaned if it is removable, and can be replaced with a new one when it becomes old or damaged. Furthermore, it can be customized to an optimum shape according to the personal preferences and convenience of the user. As shown in the modification of FIG. 3, the mouthpiece 4 can be stored in the holder 5 and may be provided so as to pop out when inhaling.

When not discharging, replace the mouthpiece 4 and replace the outside air shielding member (holder cap) 10 to shield the inside of the device from outside air and prevent intrusion of dust and bacteria as shown in Fig. 1 (b). May be. Alternatively, a shutter (not shown) may be provided at the tip of the inlet of the mouthpiece so that the shutter is closed when the apparatus is not used and the shutter is opened when discharging is performed.

The discharge head 2 has a function of discharging a drug by an ink jet system provided with a plurality of drug discharge ports, and is connected to a drug storage tank 3 for supplying a drug through a drug flow path (not shown). Yes. Further, the ejection head 2 is electrically connected to the control unit 6, and the control unit 6 has a function of sending an electrical signal instructing ejection to the ejection head 2 as necessary.

The medicine storage tank 3 is a tank that contains a predetermined amount of medicine. If a memory (not shown) for storing information such as the internal capacity of the tank 3, the type of medicine, and the date and time of manufacture is attached, the control unit 6 reads the information so that more appropriate medicine management can be performed. In addition, if the medicine is injected again into the tank once used and reused, the purity of the chemical solution may be reduced or it may be contaminated by bacteria. It is good also as a structure. In addition, a different color for each prescription may be given to the tank or medicine itself so that the user can easily identify it.

The face cap 1 opens the discharge head 2 (FIG. 1 (c)) and protects it (FIG. 1 (a)), and the protection is performed by covering the entire discharge port installation area on the discharge head 2 so as to be sealed. . The protection of the face cap 1 prevents the medicine filled in the discharge port from being directly exposed to the atmosphere except when necessary, thereby preventing evaporation of the drug from the discharge port. As a result, it is possible to prevent the deterioration of the dosing effect by preventing the change in the discharge characteristics due to the fixation of the drug near the discharge port or the alteration of the drug in the discharge port. In addition, during the protection by the face cap 1, it is possible to prevent the invasion of dust and other germs, and the contamination of the medicine to be inhaled can be prevented.

As shown in FIG. 1 (c), when the face cap 1 has the absorber 13 attached so as to be in contact with the discharge port installation area, it adheres to the discharge port installation area when the discharge port installation area is sealed. Can absorb excess chemicals and trash.

If the user has used up the prescribed amount of medicine stored in the medicine storage tank 3, or if it is necessary to replace the medicine storage tank 3 for other reasons, the medicine storage tank 3 is installed. It can be removed from the main unit and replaced. Further, the face cap 1 may be removable so that it can be replaced with a new one when its sealing function is lowered.

The medicine storage tank of this example shown in FIG. 2 (b) has a structure in which the medicine storage tank 3, the ejection head 2, and the face cap 1 can be removed as a unit and replaced. The medicine storage tank 3 and the discharge head 2 and the face cap 1 that are removed as a whole may be configured to be replaced at once, or only arbitrary members (for example, conspicuous members) may be selected and replaced. You may comprise so that it can do. At this time, if the face cap 1 is replaced with the discharge head 2 as an integrated unit, the adhesion between the discharge head 2 and the face cap 1 is optimized for each unit, and the sealing performance of the face cap 1 after replacement is reduced. Can be avoided. The As, among the ejection head 2 and the tank 3 and the face cap 1, one or Re not have two not a Re or Moshikuwai or be selectively replaced all three.

The apparatus main body is provided with a face cap opening / closing mechanism 16 that moves the face cap 1 and changes the ejection head 2 from the open state to the protected state or from the protected state to the open state. When the face cap 1 is attached to the main body of the apparatus, a protruding member protruding from the face cap 1 is inserted into an insertion port provided in the face cap opening / closing mechanism 16. In the insertion port, there is a spring member (not shown) that pushes upward while inserting a protruding member, and fixes the face cap 1 in a state of being pressed against the ejection head 2. By rotating the face cap opening / closing mechanism 16, the face cap 1 is protected and released from the ejection head 2.

At this time, a small contact sensor (not shown) is attached to a portion of the face cap 1 that contacts the ejection head 2, and the sensor and the control unit 6 are electrically connected through the insertion port of the face cap opening / closing mechanism 16. Then, the control unit 6 can detect whether the face cap 1 opens the discharge head 2 or seals it, and if the detected state is different from the predetermined state at that time, the control unit 6 It can also be controlled to give a warning.

Further, the unit in which the discharge head 2 and the medicine storage tank 3 are combined is attached to the apparatus main body along the attachment guide (holder part) 17. At this time, the mounting guide 17 presses the unit toward the contact pad 15 so that an electric signal terminal (not shown) provided in the ejection head 2 contacts the contact pad 15 on the apparatus. The ejection head 2 is electrically connected to the control unit 6 through the contact pad 15.

The control unit 6 includes a CPU that controls the entire system. In addition to the drive control of the ejection head 2, the control unit 6 communicates information with a medical database, reads / rewrites internal memory and external memory (not shown), and stores various information. Based on the control of the device, display of information on the display 9, warning to the user by voice, and the like.

The power supply unit 7 is a detachable / rechargeable battery, and the control unit 6 also monitors the power supply voltage. Further, 8 is a medicine discharge start switch, and when the discharge start switch 8 is turned on, the sealing of the discharge port installation area of the face cap 1 is opened and the medicine discharge from the medicine discharge port is started. As in the modification shown in FIG. 3, in addition to the discharge start switch 8, a switch 30 for shifting the apparatus from the standby state to the state for performing discharge in FIG. 3 is provided. Restrictions on the device that 8 cannot be turned on may be added. In this variation, when the device changes to a state where inhalation is performed by switching the switch 30, the ejection head 2 is opened by the face cap 1, the holder 5 is opened by the holder cap 10, the mouthpiece 4 is triggered by the switching of the switch 30. And the displacement of the ejection head 2 is interlocked.

Further, 12 is an antenna for remote communication, and is connected to the control unit 6. Through the external memory slot 14, the control unit 6 can exchange information such as identification data of individual users, drug prescriptions, and device malfunction history with an external memory (not shown). In this way, the medicine ejection device is configured to be carried and carried by the user, connected to an information management organization or the like via a predetermined line as a terminal, and information related to the user performing medicine inhalation Can be referenced and updated.

Here, a cartridge which is a unit in which the ejection head 2 and the medicine storage tank 3 used in this embodiment are combined will be described. The cartridge ejects a liquid medicine as fine droplets based on an ink jet system using heat or a piezoelectric effect. This is basically the same as a method that has been put into practical use in a recording apparatus such as a printer, but has some features that are different from the recording apparatus in terms of ejection heads and tanks for use in medical applications.

For example, as the constituent material of the ejection head, gold-plated material that does not react with chemicals, ceramic, glass, or the like is used. In addition, the arrangement and shape of the ejection ports (nozzles) are different depending on the type of medicine to be ejected and the method of administration (whether it is necessary to reach the lung, etc.).

The ejection drive control will be described in the case where a liquid medicine is ejected as fine droplets based on an ink jet method using heat. This method is suitable for applications in which the ejection amount is accurately managed because the number of droplets to be ejected can be controlled by the number of pulses by making the drive waveform pulsed.

However, in this embodiment, ejection control different from that of the recording apparatus is performed for use in medical use. That is, the recording apparatus performs recording by ejecting ink from above onto a recording medium such as paper. In the inhaler of the present embodiment, the medicine is ejected so as to be in the form of mist or aerosol, and the medicine is taken together with the user's inhaled air Needs to reach the lungs.

For this reason, it is necessary to perform control so that the size of the droplet is much smaller than that of a normal recording apparatus, and an appropriate amount of such a small size droplet is reliably ejected. On the other hand, when the droplet size is reduced, the kinetic energy of the ejected droplet is small, so there is no need for the ejection direction to be almost one direction as in the recording apparatus, and droplets ejected in various directions It may fly or the droplets may collide with each other.

Therefore, in this embodiment, the drive parameter is changed according to the profile (pattern) of air intake. For example, at the time of air inhalation, the amount of inhalation per unit time is large at the start time and decreases just before the end. Accordingly, when a plurality of discharges are performed within the suction time (1 second to 2 seconds), the discharge speed, the drive frequency, and the like are changed between the first discharge and the last discharge. Further, the ejection method may be changed, or the ratio of the main droplet / sub-droplet may be changed.

The flow of the medicine inhaling operation using the medicine ejection apparatus of the present embodiment described above will be described below.
First, a determination is made as to whether or not adjustments relating to drug administration to be used have been completed. Adjustment consists of initial settings for registering data such as a single dose of drug and dosing interval, and test inhalation for determining the discharge conditions by measuring the amount and profile of each user's air intake.

This adjustment operation is performed under the guidance of a specialist such as a doctor, for example, when it is diagnosed that administration of a medicine is necessary.The measured amount and profile of air inhalation and the determined discharge conditions are: It is stored as inhaler setting data in both the database and the user terminal memory card.

Next, in order to perform an actual inhalation operation, a predetermined medicine is loaded into the medicine ejection device. Then, the user is collated by combining either the password or password and biometric authentication means such as a fingerprint. When authentication that the person performing inhalation is the person is obtained, the apparatus enters a standby state for discharging medicine.

Before the actual suction operation is performed, the medicine is sucked from the discharge port using suction means (not shown) inside or outside the apparatus, and the normalization process (recovery operation) of the discharge state is performed. Thereafter, the user picks up the end of the medicine intake port of the apparatus and executes an inhalation operation. The discharge of the medicine is started by turning on the discharge start switch 8 or detecting the user's inhalation with a negative pressure sensor or the like. It is preferable to generate a signal sound or the like. When a predetermined amount of medicine is discharged by repeating inhalation several times, inhalation is completed. Also at this time, it is preferable to notify the end of inhalation by a signal sound or a display on the display 9.

[Second embodiment]
FIG. 4 shows a second embodiment of the medicine ejection device. If this apparatus is used, the reliability regarding the medicine discharge of the apparatus can be further improved. FIG. 4 schematically shows a cross section in the vicinity of the medicine ejection port of the medicine ejection device as shown in FIG.

The discharge sensor unit 18, which is an optical sensor or the like, is installed so as to be able to monitor the chemical liquid particle group discharged from the discharge head 2. By performing a small amount of discharge and monitoring the state of discharge, it is possible to inspect whether or not normal discharge is being performed.

The time when the inspection of the discharge state is necessary is, for example, immediately before the user inhales the medicine. Alternatively, it may be controlled to monitor the discharge at regular time intervals during the use standby state.

When abnormal discharge is detected as a result of the discharge state inspection, the control unit 6 takes a discharge state recovery using suction means (not shown) and a warning means to the user based on the information.

When performing the above-described discharge state inspection, the face cap 1 opens the discharge port installation area as shown in FIG. 4. At this time, if the inspection is performed with the outside air shielding member (holder cap) 10 closed, It can prevent the entry of garbage and bacteria and prevent the medicine from leaking out. If there is no problem in monitoring the discharge state when both the holder cap 10 and the face cap 1 are open, the face cap 1 and the holder cap 10 are opened as a unit as shown in FIG. It is also possible to inspect the discharge state inside. In that case, the mouthpiece 4 is configured not to interfere with the inspection. Other points are the same as in the first embodiment .

(a) is a perspective view schematically showing the entire medicine ejection apparatus according to the first embodiment of the present invention, showing a standby state, (b) is a perspective view schematically showing a part thereof FIG. 8C is a perspective view schematically showing a part of the standby state, and shows a state at the time of execution of discharge. (a) is a perspective view schematically showing the inside of the medicine ejection device of the first embodiment, showing a tank mounted state, (b) is a perspective view schematically showing the inside, with the tank removed Indicates the state. It is a perspective view showing typically the modification of the medicine discharge device which is the 1st example by the present invention, and shows the state at the time of discharge execution. It is a section lineblock diagram showing typically the inside of the medicine discharge device which is the 2nd example by the present invention, and shows the state where the inspection of the discharge state is performed .

Explanation of symbols

1 Face cap
2 Discharge head
3 Drug storage tank
4 mouthpiece
5 Holder
6 Control unit
7 Power supply unit
8 Discharge start switch
9 Display
10 Outside air shielding member (holder cap)
12 Communication antenna
13 Absorber
14 External memory slot
15 Contact pad
16 Face cap opening / closing mechanism
17 Installation guide (holder)
18 Discharge sensor unit
30 Discharge standby state transition switch

Claims (1)

A drug ejection device that ejects a drug for inhalation by a user,
A holder for accommodating therein a medicine storage tank for containing the medicine and a discharge head for discharging the medicine;
An outside air shielding member for shielding and protecting the inside of the holder from outside air ;
Having a cap for protecting the discharge port of the discharge head for discharging the medicine ;
The cap is configured integrally with the outside air shielding member, the medicine ejection device according to claim said to protect the interior of the holder by the outside air shielding member, be possible to protect the ejection head by said cap .

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