WO2018064825A1

WO2018064825A1 - Drug delivery device and system thereof

Info

Publication number: WO2018064825A1
Application number: PCT/CN2016/101536
Authority: WO
Inventors: 林智晖; 郭汉彬; 吴维修; 邹恩仑
Original assignee: 益得生物科技股份有限公司
Priority date: 2016-10-09
Filing date: 2016-10-09
Publication date: 2018-04-12

Abstract

Provided is a drug delivery device (1), comprising: an outer housing (13), a draft tube (12) and a pressure sensor unit. The outer housing (13) comprises a mouthpiece. The draft tube (12) is disposed in the outer housing (13) and is detachably coupled with the outer housing (13). And the pressure sensor unit is for detecting pressure data in the draft tube (12). The draft tube (12) can increase a pressure variation difference value measured by the pressure sensor unit. The drug delivery device (1) can make significant pressure changes, and can more accurately detect the pressure difference value caused by an inhalation action of a patient.

Description

Drug delivery device and system thereof

Technical field

The present invention relates to a drug delivery device, and more particularly to a drug delivery device and system thereof suitable for use in a metered dose inhaler.

Background technique

Therapeutic drugs for the treatment of asthma or chronic obstruction of the lungs (COPD) are mainly administered by inhalation through metered-dose inhalers (MDI), which allows the drug to be delivered directly to the respiratory organs that are not easily accessible to the drug ( Trachea, bronchi, lungs, etc.). In the past few decades, many different inhalation aids have been designed to work with MDI, allowing patients of all ages to control the discomfort caused by asthma by inhaling.

The common MDI on the market consists of a plastic box containing a metal pressurized canister containing a drug that releases the drug mist when the metal can is pushed down. In order to obtain the behavioral characteristics of the patient using traditional MDI medication, the inhaled gas flows through the patient's action of inhaling the medicament, and the gas can flow through the passage in the MDI to the sensor. At this point, the sensor can sense the flow rate pressure of the gas for this action in which the patient inhales the medicament.

However, it is generally recommended that the drug flow rate of MDI is about 30-40 L/min. With regard to the structure of the existing MDI, the flow velocity caused by the MDI is generally lower than that of the pressure sensor on the market, and is highly susceptible to noise interference. Unable to collect valid data. However, if a high-sensitivity pressure sensor is used, there are problems such as elimination of noise, limited volume, and high cost.

Summary of the invention

In view of the above problems of the prior art, it is an object of the present invention to provide a drug delivery device capable of improving the sensitivity and accuracy of a drug delivery device by increasing the difference in pressure variation.

According to an object of the present invention, a drug delivery device is provided, which may include: a drug inhaler body including a nozzle, a drug inhaler body for receiving a drug storage tank; and a draft tube detachable from the drug inhaler body In combination, the drug in the drug storage tank is ejected through the draft tube; and the pressure sensor unit detects pressure data in the draft tube; wherein the draft tube can increase the pressure variation difference measured by the pressure sensor unit.

According to another object of the present invention, a drug delivery device is provided, which may include: an outer casing, which may include a mouthpiece; a draft tube that can be placed in the outer casing and detachably coupled to the outer casing; and a pressure sensor unit The pressure data in the draft tube is detected; wherein the draft tube can increase the pressure change difference measured by the pressure sensor unit.

According to still another object of the present invention, a drug delivery device is provided, which may include: an outer casing including a mouthpiece; and a draft tube disposed in the outer casing and detachably coupled to the outer casing, wherein the draft tube includes a portion, a neck portion and a second portion, the first portion having a first cross section and the second portion having a second cross section, the cross-sectional area of the first cross-section and the second cross-section being greater than the cross-sectional area of the neck portion.

Preferably, the draft tube may include a first portion, a neck portion and a second portion, and the medicine may be ejected sequentially through the first portion, the neck portion and the second portion, wherein the first portion has a first cross section and the second portion has a first portion The cross-sectional area of the two sections, the first section and the second section may be greater than the cross-sectional area of the neck, respectively.

Preferably, the drug is sprayed from the drug storage tank in a cone spray, and the cross-sectional area of the neck is expanded by about 35 to 45% compared to the cross-sectional area of the cone spray.

Preferably, the cross-sectional area of the second section may be greater than or equal to the cross-sectional area of the first section.

Preferably, the cross-sectional area of the first section is the end of the first portion that is furthest from the second portion, and the cross-sectional area of the second section is the end of the second portion that is furthest from the first portion.

Preferably, the inner and outer shapes of the draft tube are not limited, and may be circular, rectangular, square, conical, other geometric figures or a combination thereof; the inner shape is limited to not obstruct the drug cone spray path; the outer shape The internal space of the nozzle that can be placed in the MDI or drug delivery device is dominant.

Preferably, the drug delivery device may further include a motion detecting unit disposed on the outer casing The body is electrically connected to the pressure sensor unit. In another embodiment, the motion detecting unit may be disposed on the drug inhaler body and electrically connected to the pressure sensor unit.

Preferably, the pressure sensor unit can detect the pressure data in the draft tube, and record the pressure and the number of times data when the pressure difference of the pressure data is greater than the preset pressure difference.

Preferably, the drug delivery device may further comprise a prompting unit that issues a prompt signal when the interval between the first time data and the second time data is greater than a predetermined time or the pressure difference is less than the preset pressure difference.

Preferably, the prompting unit may comprise a buzzer unit, a lighting unit, a screen display unit or a combination thereof.

Preferably, the drug delivery device may further comprise a storage unit, storage time data, pressure data, number of times data, or a combination thereof.

Preferably, the drug delivery device may further comprise a transmission unit that transmits the time data, the pressure data, and/or the number of times data to the electronic device in a wireless or wired manner.

Preferably, the transmission unit may be selected from any one or a combination of Bluetooth, RFID, NFC, WIFI, ZigBee, UWB, Li-Fi, ANT, Transfer Jet, IrDA, and MBAN.

Preferably, the motion detecting unit is selected from any one of a group consisting of a piezoelectric device, a button, and a rocking detector, or a combination thereof.

Preferably, the drug delivery device may further comprise a GPS or a gyroscope.

Preferably, the cross-sectional area of the neck may be 30-40% of the second cross-sectional area.

Preferably, the ratio of the length of the first portion to the length of the second portion may be from about 25:75 to 40:60.

Preferably, the drug delivery device can further comprise an outer casing detachably coupled to the medicament inhaler body.

Preferably, the cone spray has a diffusion angle of about 13 to 17 degrees.

Preferably, the difference in pressure change that can be increased using the apparatus of the present invention can at least increase the difference of 5 Pa, 10 Pa, 15 Pa, 20 Pa, 25 Pa, 30 Pa, 35 Pa, or 40 Pa as compared to the unused one.

According to another embodiment of the present invention, a drug delivery indication system is provided. The method includes: the drug delivery device as described above; and the electronic device, which is connected to the drug delivery device via a data transmission unit in a wireless or wired manner.

Preferably, the electronic device may comprise a notebook computer, a mobile phone, a tablet computer, a smart TV or a smart wearable device.

In general, the present invention provides a drug delivery device and system thereof that have the following advantages:

(1) According to the drug delivery device and system thereof of the present invention, the pressure sensor unit can obtain a significant pressure difference without being directly placed beside the nozzle of the drug storage tank.

(2) According to the drug delivery device and the system thereof, the different sizes of the outer casing can be manufactured for different brands and models of MDI, so that the drug delivery device can be applied to different brands and models of MDI, so that the original is not The MDI with counting or reminding function has the function of medication reminder, correct medication dosage and linkage with mobile devices.

(3) The drug delivery device and system thereof according to the present invention, because of the design of the draft tube, it does not block the ejection of the drug from the nozzle of the drug inhaler body, and since the design is used, the pressure changes significantly, and Accurately detect the difference in pressure caused by the patient's inhalation action.

(4) The drug delivery device and system thereof according to the present invention are capable of detecting a problem that the amount of inhaled drug is insufficient due to improper use. In addition, the drug delivery device can monitor the patient's MDI usage mode and remind the patient or notify the physician that the relevant information can interact with the medical staff through the cloud to understand the user's medication frequency and the number of effective medications to achieve the purpose of real-time reminding.

DRAWINGS

1 shows an exploded view of a drug delivery device in accordance with an embodiment of the present invention.

2 shows a cross-sectional view of a draft tube of three different embodiments in accordance with an embodiment of the present invention.

3 shows a flow chart of the operation of a drug delivery device in accordance with an embodiment of the present invention.

4 shows a schematic diagram of a medication delivery indication system in accordance with an embodiment of the present invention.

Figure 5 shows the spray angle and spray of commercially available MDI using a laser camera system. Schematic diagram of the results of the fog shape analysis.

6 shows a flow rate simulation diagram of a drug delivery device in accordance with an embodiment of the present invention.

Figure 7 shows a flow rate simulation diagram of a drug delivery device in accordance with another embodiment of the present invention.

In the following detailed description, numerous specific details are set forth However, it will be apparent that one or more embodiments may be practiced without the specific details. In other instances, well-known structures and processes are shown in a schematic manner in order to simplify the drawings.

detailed description

The following description of the structure of the drug delivery device according to the present invention and the manner in which it is used will be provided to assist in understanding and not limiting the scope of the claimed invention.

At present, the pressure sensor unit of the drug delivery device on the market has low sensitivity and is highly susceptible to noise interference, and the problem of unable to collect effective data has not been effectively solved. According to the Bernoulli's Principle of fluid mechanics, the moving fluid is under the low Mach number flow. Based on the law of conservation of energy, the adjustment of the pipe diameter will be influenced by the specific form (which needs to consider the turbulence and the shape of the pipe). Fluid flow rate. If the diameter is narrowed, the fluid velocity can be accelerated, resulting in a higher pressure difference. According to theory, the smaller the diameter of the pipe, the higher the pressure difference, but in practice it is impossible to reduce the pipe diameter endlessly, because the pipe diameter will affect the drug delivery path. If the delivery path of the drug spray is blocked, in addition to accumulating the drug powder on the pipe surface and affecting the gas efficiency, it is more likely to cause a decrease in the amount of the patient's medication, and it is impossible to effectively control the condition.

In order to solve the foregoing problems, the main spirit of the present invention proposes a drug delivery device comprising a draft tube, which adjusts the diameter of the draft tube based on the principle of fluid mechanics, and increases the pressure difference when the drug delivery device is administered to the market. The pressure sensor unit can stabilize the range of measurements (eg, about 120 Pa) and has a very limited effect on the drug conduction path.

More specifically, one aspect of the invention is a novel draft tube that is capable of Increase the pressure difference after the drug is ejected from the inhaled drug by the user in the metered dose inhaler. Specifically, the aforementioned pressure difference is calculated as: the pressure difference value = the pressure value measured at a measuring point when the medicine is ejected - the pressure measured at the same measuring point after the medicine leaves the drug delivery device value. Based on the disclosure of the present invention, those having ordinary skill in the art to which the present invention pertains may adopt the disclosed draft tube structure, or substantially the same as those disclosed in the present invention, but which can also improve the aforementioned pressure difference. The draft tube structure is within the scope of the claimed invention.

1 and FIG. 2, FIG. 1 is an exploded view of a drug delivery device incorporating a guide tube of the present invention (ie, a three-section diversion of the portion of FIG. 2(A), in accordance with an embodiment of the present invention. Figure 2 is a cross-sectional view of a draft tube in accordance with three different embodiments of the spirit of the present invention. In a possible implementation manner, the foregoing draft tube may be a three-section draft tube (parts of FIG. 1 and FIG. 2 (A)), a tapered draft tube (part of FIG. 2 (B)), or a straight-through draft tube (figure Part 2 (C)). In the embodiment shown in FIG. 2, the drug delivery path is an example from the left side of the drawing to the right side of the drawing, and is not limited thereto.

The "three-section draft tube" according to the present invention means that the draft tube can be mainly composed of a three-layer cross section. In detail (part of Fig. 2(A)), the first section A (into the section), the section of the neck 122 (increasing section), and the second section B are sequentially taken from the spraying hole of the drug storage tank ( The discharge cross section of the patient's mouth contact). In an embodiment, the cross-sectional area of the first section A may be located at one end of the first portion that is furthest from the second portion, and the cross-sectional area of the second section B may be located at an end of the second portion that is furthest from the first portion. It should be noted that the first section A to the neck portion 122 is the first portion 121 of the draft tube 12, and the section from the neck portion 122 to the second section B is the second portion 123 of the draft tube 12. . In an embodiment, the ratio of the length of the first portion to the length of the second portion is from 25:75 to 40:60. Preferably, the ratio of the length of the first portion to the length of the second portion is from 27:73 to 32:68. Most preferably, the ratio of the length of the first portion to the length of the second portion is 30:70.

Referring to FIG. 6 again, FIG. 6 is a flow chart simulation diagram of a drug delivery device equipped with the three-section draft tube of the present invention, wherein part (A) is a flow chart of 30 L/min, and part (B) is 40 L/min. Flow rate simulation map. As shown in the figure, in the design of each section, the use of jet The principle of propulsion is such that the cross-sectional area of each section is sequentially the cross section of the second section B ≥ first section A> neck 122. That is to say, in the three-section draft tube in this embodiment, the cross-sectional area gradually increases from the neck portion 122 to the two end points. It should be noted that the section of the cross section of the first section A to the neck 122 can integrate and guide the air flow, so the cross section of the first section A should be slightly larger than the section of the section of the neck 122. According to the design of the draft tube according to an embodiment of the present invention, when each airflow enters the pipeline of the draft tube, it is quickly integrated into the stable laminar flow at the neck portion 122. In contrast, the effectiveness of the draft tube to increase the pressure differential can be derived from the ratio of the cross-sectional area of the section of the neck 122 to the second section B. In one embodiment, the cross-sectional area of the cross-section of the neck portion 122 is 30-40% of the cross-sectional area of the second cross-section. In a preferred embodiment, the cross-sectional area of the cross-section of the neck portion 122 is 32 to 38% of the cross-sectional area of the second cross-section. Most preferably, the cross-sectional area of the section of the neck 122 is 35% of the cross-sectional area of the second section. In these embodiments, the pressure measurement can be effectively increased to a valid range under normal medication conditions.

If you want to further consider the delivery route of the drug spray, please use the laser imaging system (Oxford Laser Envision System) to spray the spray angle and spray shape on the commercially available MDI (Duasma, Quantitative Spray, Jian Qiao). A schematic diagram of the results of the analysis. After analysis, the diffusion angle of the generally commercially available MDI drug spray path is about 13 to 17 degrees, depending on the device. For example, the MDI shown in the portion of FIG. 5(A) has a spray angle of about 15.1 degrees; the MDI shown in the portion of FIG. 5(B) has a spray angle of about 14.2 degrees. Therefore, in the design of the conduit of the draft tube, it is necessary to effectively avoid the drug conduction path and control the influence of the corresponding turbulence on the path. That is to say, the sections of the sections of the conduit of the draft tube 12 must be evaded from the tapered spray space (or cone-shaped space) at the time of administration of the aforementioned MDI device.

In terms of airflow pattern, at the clinically recommended inspiratory flow rate (30 L/min to 40 L/min), it can be observed that significant turbulence occurs when the airflow flowing from the drug storage tank is collected. Therefore, in an embodiment, in the design of the draft tube, the cross-sectional area of the neck can be amplified and expanded relative to the cross-sectional area of the cone spray according to the cone spray pattern of the drug sprayed by different MDI devices. About 35 to 45% of the space (about 37 to 43% in a preferred embodiment; about 42% in a more preferred embodiment) to avoid turbulence caused by the wall edge of the tube influences. It will be understood by those of ordinary skill in the art to which the present invention pertains that a cone can be viewed as a stack of innumerable sections. Therefore, "the cross-sectional area of the neck relative to the cross-sectional area of the cone spray" as used herein means that the cone-shaped spray is regarded as a cone, and the cross section of the cone in the same plane is compared with the neck. The area of the section. For example, the cross-sectional area of the cone spray of the drug sprayed relative to the neck may be 38% of the cross-sectional area of the neck to avoid turbulence.

On the other hand, as shown in Figs. 2(B) and (C), the draft tube of the present invention may be a tapered draft tube or a straight through draft tube. The "conical draft tube" of the present invention means that the draft tube has a diverging tube diameter change such that the draft tube forms a cone. The tapered draft tube is coupled to the drug inhaler body at its apex end (ie, the end having a smaller diameter) and is coupled to the mouth of the user at its bottom end (ie, the end having the larger diameter). The "straight-through draft tube" as used in the present invention means that the draft tube has no or substantially no change in tube diameter. It should be noted that, in the preferred case, the diameter of the straight-through draft tube should be smaller than the diameter of the nozzle of the drug inhaler body.

In order to improve the safety and effectiveness of medication for patients with asthma or chronic lung obstruction, and at the same time let the doctor know the patient's condition and remind the patient to use the medicine correctly, another aspect of the present invention provides a drug delivery device equipped with the aforementioned invention. Diversion tube. Referring to FIG. 1, the drug delivery device 1 shown in the drawings may include a drug inhaler body 11 including a nozzle 111 and accommodating a drug storage tank 2; a draft tube 12, which is compatible with the drug inhaler body 11 Separately coupled, the draft tube 12 includes a first portion 121, a neck portion 122, and a second portion 123. The drug in the drug storage tank 2 is sequentially ejected through the first portion 121, the neck portion 122, and the second portion 123, wherein The portion 121 has a first section A and the second portion 123 has a second section B, the cross-sectional areas of the first section A and the second section B being greater than the cross-sectional area of the neck 122, respectively. In a preferred embodiment, the drug delivery device 1 can further include an outer casing 13 that is detachably coupled to the medicament inhaler body 11. Further, as shown in the embodiment of the drawing, the draft tube 12 is housed in the inner space of the outer casing 13.

The draft tube 12 can be detachably coupled to the nozzle 111 of the drug inhaler body 11. That is, the draft tube 12 can be mounted on the drug inhaler body 11, and the user can select an appropriate size of the draft tube 12 as needed (eg, the size of the different drug inhaler body 11). The first portion 121 of the draft tube 12 can be brought into close contact with the drug inhaler body 11 so that the drug spray ejected from the drug storage tank 2 can pass completely through the draft tube 12. Therefore, at the time of use, the medicine ejected from the nozzle 111 of the drug inhaler body 11 sequentially passes through the first portion 121, the neck portion 122, and the second portion 123 of the guide tube 12, and then reaches the respiratory tract of the user. It should be noted that, as described in the foregoing paragraphs, the structure design of the draft tube 12 of the present invention can improve the transmission efficiency of the drug delivery device by increasing the pressure variation difference, and can also increase the pressure in the drug delivery device. The sensitivity and accuracy of the detector.

Similarly, the present invention further provides a drug delivery device (not shown) comprising an outer casing and a draft tube, the connection relationship of which is similar to that of the drug delivery device 1, and details are not described herein. In this embodiment, the outer casing has a mouthpiece for the user to inhale the drug, and the draft tube is housed in the outer casing, and the draft tube is detachably coupled to the outer casing. According to the size of the existing drug inhaler, the user can select an appropriate size of the draft tube and the outer casing according to the demand, and install the guiding tube and the outer casing on the existing drug inhaler to make the drug in the drug inhaler. It can be sprayed out through the mouthpiece of the draft tube and the outer casing in order to allow the user to inhale.

In an embodiment, the medicament inhaler body 11 can be made of plastic, which can accommodate a drug storage tank 2, such as a metal pressurized canister, and the drug storage tank 2 contains a drug, which can be guided when the drug storage tank 2 is pushed down. The flow tube 12 releases the drug mist. In another embodiment, the drug inhaler body 11 can also be made of other materials conventional in the art to which the present invention pertains.

According to another embodiment of the present invention, the present invention further provides a drug delivery device, which comprises components and connection relationships as described in the drug delivery device 1, and details are not described herein. The difference is that the drug delivery device further includes a motion detecting unit (not shown) and a pressure sensor unit (not shown). In a preferred embodiment, the motion detecting unit and the pressure sensor unit may be disposed on the drug inhaler body 11 and electrically connected to each other. In another embodiment, when the drug delivery device 1 has the outer casing 13, the motion detecting unit and the pressure sensor unit may be disposed on the outer casing 13. It should be noted that the motion detecting unit and the pressure sensor unit can be disposed at any position of the drug delivery device 1 according to the user or design requirements, as long as the function or use in the drug delivery device 1 is not affected.

In an embodiment, when the motion detecting unit detects the motion of the user, it records time data. On the other hand, through the motion detection unit, it is also possible to detect whether the patient has achieved the correct medication action and behavior when using the medicine, that is, to detect whether the patient uses the drug delivery device with the correct gesture to ensure correct and appropriate amount. Administration.

In a preferred embodiment, the pressure sensor unit detects pressure data of the draft tube and calculates a pressure difference. When the pressure difference is greater than the preset pressure difference, pressure data, time data, and/or number of times data are recorded. In a preferred embodiment, the pressure sensor unit detects pressure data of the first portion 121 and/or the neck portion 122 between the first section A and the neck cross-sectional area (including the cross-sectional area) and calculates a pressure difference. In another preferred embodiment, the pressure sensor unit detects pressure data at the neck portion of the draft tube and calculates a pressure differential.

Please refer to FIG. 3, which is a flow chart of the operation of the drug delivery device according to an embodiment of the present invention. Step S11: When the motion detecting unit detects the motion of the user, the time data is recorded. The motion detecting unit may include a piezoelectric device, a button, or a shake detector. For example, when the user wants to use the drug delivery device for administration, pressing a button on the drug delivery device or shaking the drug delivery device, the motion detection unit detects the user's motion, and records the current time as time data. It can also measure whether the patient is taking the medicine with the correct gesture. Step S12: When the user presses the drug storage tank to eject the medicine and inhales the medicine, the pressure sensor unit detects the pressure values when the medicine is ejected and when the medicine is inhaled, and calculates the pressure difference, wherein the pressure difference is = the pressure value measured at the pressure sensor unit when the drug is ejected - the pressure value measured at the pressure sensor unit after the drug leaves the drug delivery device. Step S13: determining whether the pressure difference is greater than a preset pressure difference. If so, the time data and the number of times data are recorded (step S14), indicating successful administration; if not, only time data is recorded (step S15), indicating that the administration was not successful.

In an embodiment, the drug delivery device may further include a prompting unit (not shown) such as a buzzer unit or a light unit, a screen display unit, and the like. When the interval between the first time data and the second time data is greater than a predetermined time, that is, after the first time data recording, after the predetermined time has elapsed, when the second time data is not generated, the prompting unit transmits the sound, the flashing light, the subtitle, The icon or combinations of these remind the user to administer. For example, the first time data is 8:00, and the predetermined time is 6 hours, that is, when the second time data is not generated at 14:00, The user will be alerted by sound, flashing lights, subtitles, icons or a combination of these. Or, when the pressure difference detected by the pressure sensor unit is less than the preset pressure difference, it indicates that the drug is not successfully administered, and the prompting unit can also remind the user through sound, flashing lights, subtitles, icons or the combination thereof. If the drug is not successfully administered, the procedure of administration is required again. For example, the preset pressure difference is 100 Pa. When the pressure difference detected by the pressure sensor unit is 80 Pa, that is, when the detected pressure difference is less than the preset pressure difference, the sound is transmitted through the sound, the flashing light, Subtitles, icons, or combinations of these remind the user.

In an embodiment, when the light-emitting unit is used as the prompting unit, the light-emitting unit can pass the default or built-in mode such as light and dark, color difference or flashing time interval, so that the user knows whether to hold the medicine in the correct manner and the power status of the device. , or whether the system or online status is normal. This is merely an example, and the manner and type of the prompt are not limited thereto.

According to another embodiment of the present invention, the drug delivery device may further include a transmission unit such as Bluetooth, RFID, NFC, WIFI, ZigBee, UWB, Li-Fi, ANT, Transfer Jet, IrDA or MBAN, or the like. The recorded time data and/or the number of times data can be transmitted to the electronic device such as a notebook computer, a mobile phone, a tablet computer, a smart TV, or a smart wearable device by wireless or wired. Alternatively, the drug delivery device may include a storage unit that stores time data, pressure on the drug delivery device before the recorded time data, pressure data, and/or number of times data has not been transmitted to the electronic device or cannot be transmitted to the electronic device. Data and/or number of times data.

Please refer to FIG. 4. FIG. 4 is a schematic diagram of a medication delivery indication system according to an embodiment of the present invention. According to another embodiment of the present invention, a drug delivery instruction system is provided, comprising: a drug delivery device 1; and an electronic device 3 connected to the drug delivery device 1 via a data transmission unit 31 in a wireless or wired manner. In a preferred embodiment, the electronic device can be a notebook computer, a mobile phone, a tablet computer, a smart TV, or a smart wearable device.

In an embodiment, the drug delivery device 1 and the electronic device 3 are connected by wireless transmission methods such as Bluetooth, RFID, NFC, WIFI, ZigBee, UWB, Li-Fi, ANT, Transfer Jet, IrDA or MBAN to The time data and the number of times data detected by the transfer device 1 are transmitted to the electronic device 3. In a preferred embodiment, the electronic device Can be a smart phone. The smart phone includes a mobile phone application (APP), which can communicate with the transmission unit of the drug delivery device through the APP, and connect and exchange data via a Bluetooth connection. In another preferred embodiment, the drug delivery device 1 and the electronic device 3 are connected and exchange data through a cloud server.

According to the foregoing drug delivery device and/or drug delivery indication system, the prompting unit on the drug delivery device can be used to remind the patient whether the drug is successfully administered or not. On the other hand, doctors can also use the electronic device to connect to the cloud or use other wireless transmission methods to obtain information on the patient's medication (including when to use the medicine, whether to use the medicine correctly, whether the inspiratory volume is sufficient, etc.), to understand the patient's medication status and to remind them in real time. The patient took the medicine.

Related tests of the guiding tube and the drug delivery device of the present invention:

Part (A) of Figure 5 is the spray angle of the commercial Duasma (Di Shuma quantitative spray solution, Jian Qiao Xinyuan). As shown, Duasma's MDI has a spray angle of approximately 15.1 degrees. The spray particle size and flow pressure values were measured before and after the three-section draft tube of the present invention was attached to the MDI of Duasma. In this embodiment, the ratio of the length of the first portion to the second portion of the draft tube is 30:70, and the cross-sectional area of the neck is about 35% of the cross-sectional area of the second section.

Spray particle size and flow pressure value test:

instrument:

Next Generation Impactor (model: 170), sampling device (Sampling apparatus), flow meter (Flowmeter, model: DFM2), high-throughput pump (Model: HCP5) and NGI leak detector ( NGI Leak Tester, serial number: LT-0057).

The above instruments are used to simulate and measure the distribution of drug particle size in the lungs, in accordance with the specifications indicated in the US or European Pharmacopoeia.

Steps:

First, each component of the next-generation impactor device is accurately placed at the relevant position, and a close-close test is performed to confirm that the air pressure does not leak. A guide tube is then connected to the impactor inlet and the other guide tube is connected to the high flux pump and the outlet of the impactor. Open the pumping pump and measure with a flow meter and adjust to the required flow rate (20L/min ± 5% to 70L/min ± 5%). Spraying a drug delivery device according to an embodiment of the present invention The mouth and the impactor are linked by a mouthpiece adapter, and it is confirmed that the number of pumping seconds is set after the close contact, and a pumping dose is immediately ejected into the impactor while the pumping is started. After the end of the evacuation, the guide tube and the sample on the collection tray were collected according to the test method procedure of each test drug. Wherein, when the draft tube is installed or not installed, the position of the pressure sensor unit placed is the same vertical point. And when measuring the pressure value, it is necessary to deduct the background value error caused by the shaking.

The experimental results are shown in Table 1 below.

Table 1: Pressure difference at different flow rates and pumping for 7 seconds

#压力差变化变化=(pressure difference when there is a draft tube - pressure difference when there is no draft tube) / pressure difference when there is no draft tube *100%

N/A: Unmeasurable or impossible to calculate

It is worth noting that when the draft tube is not installed, the test is performed at a flow rate of 30 L/min, and the measured pressure value is unstable, and there are many values that cannot be measured. From the results of Table 1, regardless of the flow rate of 30, 40 or 60 L / min, after the installation of the draft tube in the drug delivery device, the conduit of the draft tube can effectively increase the pressure difference, for example, at a flow rate of 40 L / min The pressure difference can be increased from 71Pa to 134Pa, an increase of about 88%.

Referring to FIG. 7, FIG. 7 is a flow rate simulation diagram of (A) a straight-through draft tube and (B) a tapered draft tube according to an embodiment of the present invention.

When the draft tube is not installed in Table 1, the test at a flow rate of 30 L/min has not been able to detect any numerical conditions. Compared with Table 2, it is shown that the installation of different shapes of the draft tube can increase the pressure difference. In detail, as shown in FIG. 7 and Table 2 below, based on the experimental data, the effects of different shapes of the draft tubes on the pressure are compared interactively. In terms of the duct type of the draft tube, the tapered draft tube performs better than the other two for the increase of the pressure difference. In particular, the tapered draft tube can increase the pressure by more than 60% compared with the three-section draft tube shown in FIG. Force difference. Among them, the straight-through draft tube has the worst effect, although the pressure difference can be increased, but the pressure difference is reduced by about 26% compared with the three-section draft tube.

However, as shown in Fig. 7, if the airflow path is observed, it can be found that the straight flow guiding tube and the tapered draft tube generate turbulent flow at the outlet, and the turbulent flow in the tapered draft tube accounts for about 40% of the cross section, if the flow rate The lift can be slightly improved; the straight-through draft tube causes 80% of the turbulent flow of the cross section, which may disturb the drug delivery effect.

Table 2: Pressure difference of different draft tubes.

That is to say, if the pressure difference is used as the evaluation index, the effect of the tapered draft tube is better. However, it is worth noting that although the cone-shaped draft tube can effectively increase the pressure difference, there is no effective rectification mechanism to cause some turbulent flow, which may cause the influence of the drug delivery path.

Further, a comparison of the placement positions of the pressure sensor units is performed. In this embodiment, the setting of the human lung inspiration for 3 seconds was simulated at a flow rate of 40 L/min.

Table 3: Pressure difference of the pressure sensor unit at different positions of the draft tube and pumping for 3 seconds.

As can be seen from the results of Table 3, regardless of whether the pressure sensor unit is disposed near the end of the spout, away from the end or intermediate point of the spout, a high pressure can be effectively detected by installing a draft tube according to an embodiment of the present invention. Difference. That is to say, increasing the draft tube does increase the pressure difference and provides a stable pressure difference without the background error.

On the other hand, by measuring the drug spray path and the drug recovery rate, it is confirmed whether the drug inhaler is disposed after the introduction of the draft tube according to an embodiment of the present invention. In this embodiment, the cross-sectional area of the neck of the draft tube is 42% larger than that of the cone spray. In terms of the drug spray path, according to the measurement results, after the introduction of the draft tube according to an embodiment of the present invention, the average deviation of the axis of the drug spray path is about 0.2 degrees, which does not affect the path of the actual drug spray. On the other hand, in terms of administration results, after the introduction of the draft tube according to an embodiment of the present invention, the effective dose of the drug inhaler (Fine Particle Fraction) is reduced by only 2.5% on average, and The drug recovery rate decreased by an average of 7.7%, which was not statistically significant, ie, had no significant effect. This also means that the diversion tube according to an embodiment of the present invention does not affect the administration effect of the drug inhaler without effectively increasing the pressure measurement value to the effective range.

In summary, according to the design of the draft tube in the drug delivery device of the present invention, Bernoulli's law is applied to regulate the diameter of the tube, so that the degree of the tube can effectively increase the pressure difference and the cone-shaped range for drug conduction. Dodge to avoid affecting the drug conduction path. Finally, using the knowledge of fluid mechanics pipelines, in the form of three-layer cross-section, the airflow is first integrated and stabilized, and the key shrinkage area ratio is created, and the flow rate is effectively increased to create the stability of sensing.

The above description is merely exemplary and not limiting. Any equivalent modifications or alterations to the spirit and scope of the invention are intended to be included within the scope of the invention.

【Symbol Description】

1: drug delivery device

11: drug inhaler body

111: Nozzle

12: guide tube

121: Part one

122: neck

123: Part II

13: outer casing

2: drug storage tank

3: Electronic device

31: Data transmission unit

A: First section

B: second section

S11~S15: Steps

Claims

A drug delivery device comprising:

a medicament inhaler body comprising a nozzle for containing a drug storage tank;

a draft tube detachably coupled to the drug inhaler body, the drug in the drug storage tank being ejected through the draft tube; and

a pressure sensor unit for detecting pressure data in the draft tube;

The draft tube can increase the difference in pressure variation measured by the pressure sensor unit.
The apparatus of claim 1 further comprising:

The motion detecting unit is disposed on the drug inhaler body and electrically connected to the pressure sensor unit.
The apparatus of claim 2 further comprising:

The prompting unit can issue a prompt signal.
A drug delivery device comprising:

An outer casing comprising a mouthpiece;

a draft tube disposed in the outer casing and detachably coupled to the outer casing; and

a pressure sensor unit for detecting pressure data in the draft tube;

The draft tube can increase the difference in pressure variation measured by the pressure sensor unit.
The apparatus of claim 4 further comprising:

The motion detecting unit is disposed in the outer casing and electrically connected to the pressure sensor unit.
The apparatus of claim 5 further comprising:

The prompting unit sends a prompt signal.
A device according to any one of claims 4 to 6, further comprising a drug inhaler body detachably coupled to the outer casing.
Apparatus according to any one of claims 1 to 6 wherein the draft tube comprises a first portion, a neck portion and a second portion, the drug being sequentially ejected through the first portion, the neck portion and the second portion, wherein the first portion has a first cross section and the second portion has a second cross section, the first portion The cross-sectional area of a section and the second section is greater than the cross-sectional area of the neck, respectively.
The device according to claim 8, wherein the drug is sprayed in a cone spray, wherein the cross-sectional area of the neck is expanded by 35 to 45% with respect to the cross-sectional area of the cone spray.
The apparatus of claim 8 wherein the cross-sectional area of the second section is greater than or equal to the cross-sectional area of the first section.
The device according to claim 8, wherein the neck portion has a cross-sectional area of 30 to 40% of the cross-sectional area of the second section.
The apparatus according to any one of claims 1 to 6, further comprising a storage unit that stores the time data, the pressure data, the number of times of data, or a combination thereof.
The apparatus according to any one of claims 1 to 6, further comprising a transmission unit that transmits the time data, the pressure data, the number of times of data, or a combination thereof to the electronic device in a wireless or wired manner.
The apparatus according to claim 13, wherein the transmission unit is selected from any one or a combination of the group consisting of Bluetooth, RFID, NFC, WIFI, ZigBee, UWB, Li-Fi, ANT, Transfer Jet, IrDA, and MBAN. .
The device according to claim 2 or 5, wherein the motion detecting unit is selected from any one of a group consisting of a piezoelectric device, a button and a rocking detector, or a combination thereof.
The apparatus according to claim 3 or 6, wherein the prompting unit comprises a buzzer unit, a light emitting unit, a screen display unit, or a combination thereof.
The device of claim 8 wherein the ratio of the length of the first portion to the length of the second portion is from 25:75 to 40:60.
A drug delivery indication system comprising:

A device according to any one of claims 1 to 17;

The electronic device is connected to the drug delivery device via a data transmission unit in a wireless or wired manner.
The system of claim 18 wherein the electronic device comprises a note This computer, mobile phone, tablet computer, smart TV or smart wearable device.
A drug delivery device comprising:

An outer casing comprising a mouthpiece; and

a draft tube disposed in the outer casing and detachably coupled to the outer casing, wherein the draft tube includes a first portion, a neck portion and a second portion, the first portion having a first cross section and the second portion having a second cross section The cross-sectional area of the first section and the second section is greater than the cross-sectional area of the neck.