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WO2019212442A2 - Procédé de surveillance d'utilisation d'un inhalateur - Google Patents

Procédé de surveillance d'utilisation d'un inhalateur Download PDF

Info

Publication number
WO2019212442A2
WO2019212442A2 PCT/TR2019/050141 TR2019050141W WO2019212442A2 WO 2019212442 A2 WO2019212442 A2 WO 2019212442A2 TR 2019050141 W TR2019050141 W TR 2019050141W WO 2019212442 A2 WO2019212442 A2 WO 2019212442A2
Authority
WO
WIPO (PCT)
Prior art keywords
inhaler
inhalation
drug
monitoring method
usage monitoring
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Ceased
Application number
PCT/TR2019/050141
Other languages
English (en)
Other versions
WO2019212442A3 (fr
Inventor
Merthan OZTURK
Kerem YASAR
Ahmet OGUZ
Burak SONMEZ
Ahmet Burak AKTAS
Kadir Tayyip TASLICA
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Inofab Saglik Teknolojileri AS
Original Assignee
Inofab Saglik Teknolojileri AS
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Priority claimed from TR2018/03793A external-priority patent/TR201803793A2/tr
Application filed by Inofab Saglik Teknolojileri AS filed Critical Inofab Saglik Teknolojileri AS
Publication of WO2019212442A2 publication Critical patent/WO2019212442A2/fr
Publication of WO2019212442A3 publication Critical patent/WO2019212442A3/fr
Anticipated expiration legal-status Critical
Ceased legal-status Critical Current

Links

Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M15/00Inhalators
    • A61M15/0065Inhalators with dosage or measuring devices
    • A61M15/0068Indicating or counting the number of dispensed doses or of remaining doses
    • A61M15/008Electronic counters
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00Measuring for diagnostic purposes; Identification of persons
    • A61B5/08Measuring devices for evaluating the respiratory organs
    • A61B5/087Measuring breath flow
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B7/00Instruments for auscultation
    • A61B7/003Detecting lung or respiration noise
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M15/00Inhalators
    • A61M15/0028Inhalators using prepacked dosages, one for each application, e.g. capsules to be perforated or broken-up
    • A61M15/003Inhalators using prepacked dosages, one for each application, e.g. capsules to be perforated or broken-up using capsules, e.g. to be perforated or broken-up
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M15/00Inhalators
    • A61M15/0028Inhalators using prepacked dosages, one for each application, e.g. capsules to be perforated or broken-up
    • A61M15/003Inhalators using prepacked dosages, one for each application, e.g. capsules to be perforated or broken-up using capsules, e.g. to be perforated or broken-up
    • A61M15/0033Details of the piercing or cutting means
    • A61M15/0041Details of the piercing or cutting means with movable piercing or cutting means
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M15/00Inhalators
    • A61M15/009Inhalators using medicine packages with incorporated spraying means, e.g. aerosol cans
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2205/00General characteristics of the apparatus
    • A61M2205/33Controlling, regulating or measuring
    • A61M2205/3375Acoustical, e.g. ultrasonic, measuring means
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2205/00General characteristics of the apparatus
    • A61M2205/35Communication
    • A61M2205/3546Range
    • A61M2205/3569Range sublocal, e.g. between console and disposable
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2205/00General characteristics of the apparatus
    • A61M2205/35Communication
    • A61M2205/3576Communication with non implanted data transmission devices, e.g. using external transmitter or receiver
    • A61M2205/3592Communication with non implanted data transmission devices, e.g. using external transmitter or receiver using telemetric means, e.g. radio or optical transmission
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2205/00General characteristics of the apparatus
    • A61M2205/50General characteristics of the apparatus with microprocessors or computers
    • A61M2205/502User interfaces, e.g. screens or keyboards
    • A61M2205/505Touch-screens; Virtual keyboard or keypads; Virtual buttons; Soft keys; Mouse touches
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2205/00General characteristics of the apparatus
    • A61M2205/50General characteristics of the apparatus with microprocessors or computers
    • A61M2205/52General characteristics of the apparatus with microprocessors or computers with memories providing a history of measured variating parameters of apparatus or patient
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2205/00General characteristics of the apparatus
    • A61M2205/58Means for facilitating use, e.g. by people with impaired vision
    • A61M2205/587Lighting arrangements
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2205/00General characteristics of the apparatus
    • A61M2205/82Internal energy supply devices
    • A61M2205/8206Internal energy supply devices battery-operated

Definitions

  • the invention is related to an inhaler usage monitoring method which enables the monitoring of the correct use of an inhaler device intended to deliver medication to the lungs and which records information such as the number of uses and time of usage.
  • inhalers which aerosolize drugs by letting the air pass through a restricted cross-section during the user's inhalation are used.
  • the user In order to prevent the medication from accumulating at a different part of the respiratory tract without reaching the lungs, the user needs to inhale at a particular rate. Solutions developed with the purpose of providing feedback to the user regarding the correct inhalation rate are known in the art. Inhalers have been described in the document numbered US2016256641A1 in which inhalation is carried out through a straw along the airway, and in the document numbered GB25146S2A, by means of using a narrow section along the airway or an electronic sound generator which generates sound when correct inhalation takes place.
  • the aim of this invention is to develop an inhaler usage monitoring method which enables to control that the user has inhaled the drug with a correct inhalation rate and duration during the use of the inhaler.
  • Another purpose of this invention is to develop an inhaler usage monitoring method which provides feedback to the user.
  • Another purpose of this invention is to develop an inhaler usage monitoring method which can create a profile of the air flow.
  • Another purpose of this invention is to develop an inhaler usage monitoring method which has low energy consumption.
  • Another purpose of this invention is to develop an inhaler usage monitoring method which enables recording time of inhaler use.
  • Figure 1 is the front view of a dry powder inhaler.
  • Figure 2 is the side view of a dry powder inhaler.
  • Figure 3 is the front view of a dry powder inhaler with an inhaler attachment.
  • Figure 4 is the side view of a dry powder inhaler with an inhaler attachment.
  • Figure 5 is the front view of a metered dose inhaler.
  • Figure 6 is the side view of a metered dose inhaler.
  • Figure 7 is the front view of a metered dose inhaler with an inhaler attachment according to the invention.
  • Figure 8 is the side view of a metered dose inhaler with an inhaler attachment according to the invention.
  • Figure 9 is a sample flow chart related to performing and assessing the measurements of the method according to the invention in order to monitor the use of a metered dose inhaler.
  • Figure 10 is a sample flow chart related to performing and assessing the measurements of the method according to the invention in order to monitor the use of a dry powder inhaler. Definition of the Parts forming the Invention
  • the inhaler attachment (1) which enables to perform method subject to the invention is used together with an inhaler (2) which comprises an airway between a mouthpiece (3), which rests on the mouth of the user, and at least one air inlet (4).
  • the inhaler (2) also comprises a drug release mechanism which releases the medicine in order to aerosolize it by means of a drug chamber, in which at least one medicine that needs to be delivered to the lungs of the user during inhalation is filled and which keeps this medicine along the airway with the purpose of aerosolizing it during the user's inhalation.
  • the method of the invention is performed by means of a hardware located on the attachment (1) that is attached to the inhaler (2) and which is absent from most common inhalers (2) in the market, it is possible to perform the method by means of the hardware already present on the inhaler (2). Therefore, the inhaler (2) only needs to have been produced in order to contain the related hardware.
  • a pre-metered dry powder inhaler (2) dry powder inhaler - DPI
  • the powdered medicine within a single-dose capsule or a blister containing multiple number of single dose cells is aerosolized during the user's inhalation.
  • the drug release mechanism comprises a button (5) which contains at least one needle in order to release the drug within the capsule and pushes the needle in order to pierce the capsule when it is pressed by the user.
  • the powdered drug is carried by the air flow during the user's inhalation and delivered to the user.
  • air inlets (4) which have a direction that, preferably, does not intercept the direction of the airway.
  • the air flow rotates the capsule by creating a vortex in the drug area and provides the release of the powdered drug.
  • inhalers (2) based on transferring a specific drug amount to the drug area from a housing, instead of a capsule, are present. The drug is carried to the target are by the inhalation of the user.
  • a canister (6) containing a drug which is a spray fluid or which can be carried by a spray fluid is placed into the drug chamber.
  • the drug release mechanism comprises a valve which enables a specific amount of drug to be sprayed by being triggered by the user in order to release the drug in the canister. The user triggers the drug release during their inhalation and the drug is delivered to the target area by means of the air flow provided by the user's simultaneous inhalation with the spray of the drug release mechanism.
  • the inhaler attachment (1) basically comprises - a body (7) which is fits on the inhaler (2) and carries the other components, at least one vibration sensor which measures the vibrations in the inhaler (2) during the user's inhalation and drug release, a processor which evaluates the data from the vibration sensor.
  • the attachment (1) is removable.
  • flexible parts can be present on the body (7) or its extensions.
  • the vibration sensor can be a microphone.
  • the vibration data is compared to the recorded vibrations corresponding to possible statuses and the specific values of the related magnitude. As a result of this comparison, the magnitude and the inhaler status corresponding to the vibration sensor data can be detected.
  • the mentioned magnitude information allows creating a profile which is composed of a graphic that enables visualizing the change of the related values, or a data set comprising the related values in relation to measurement time, by means of time and monitoring the air flow provided by the user. The status information obtained enables monitoring of the drug release.
  • the magnitude and status information can be used together to perform the drug release at the proper respiration rate for the subject drug and detect whether this respiration rate is continued for a while after the drug release.
  • the magnitude information and the status information can be kept in memory in the body of the attachment (1) or an external location, and notified to the user.
  • the proper respiration rate and duration can be different for different drugs. Therefore, the proper use information for more than one drug can be kept on the attachment (1) or a server accessible to the attachment (1).
  • the proper use information for each drug is composed of the proper respiration rate depending on time throughout the proper respiration duration.
  • This proper use data can be expressed as reference profiles. After the user chooses from these medications, the proper respiration rate and duration can be evaluated in the light of the proper use information defined for the chosen drug. With the reference profiles presented to the user together with the actual profile after the use or preferably, real-time, enables the user to improve themselves.
  • the subject method basically comprises the steps of; beginning from the point that it is detected that the inhalation has started to the termination of the inhalation, determining the instantaneous flow rate and recording the instantaneous flow rate and the corresponding time of measurement, - within the instantaneous flow rate and the corresponding measurement time series, determining a subseries corresponding to the beginning segment of the inhalation process, calculating at least one variable which will be evaluated during the inhalation process and within the beginning segment, retrieving the variable values corresponding to the proper inhalation manner, comparing the calculated and proper values and generating a feedback in line with the comparison results.
  • Vibration data is, preferably, used for detecting that the inhalation has started and ended and for the measurement of the instantaneous flow rate.
  • the drug can reach the farthest point possible within the lungs right after the start of inhalation. Thanks to determining the data subseries corresponding to the beginning segment, this stage can be evaluated efficiently.
  • the beginning segment is a specific ratio of the inhalation time or a specific period of time starting from the commencement of the inhalation time. This proportion or duration can be predefined as well as being adjusted according to the drug or the user's need.
  • the variables to be evaluated correspond to at least one factor which affects the delivery and dissipation of the drug to the lungs, such as the time of drug release, the flow rate provided following the drug release, total inhalation time, total inhalation volume and the duration time that falls within the beginning segment following the drug release and the highest flow rate within the beginning segment following drug release.
  • variable values that correspond to proper inhalation manner can be retrieved from a memory or a server.
  • variable values which correspond to proper inhalation manner for more than one medication can be used.
  • the method subject to the invention comprises a drug selection step. This step is preferably carried out once, and the drug preference is saved and used each time the method is performed. Nevertheless, it is possible to select the drug again each time the method is performed, hence, at each time of use.
  • An exemplary embodiment of the invention for monitoring the use of a metered dose inhaler (2) basically comprises the steps of; (101) detecting the beginning of inhalation,
  • Detection of the drug release can be realized by detecting that the drug release mechanism is triggered or by evaluating vibration data.
  • the steps 106, 107 and 108 do not take place regarding the detection and evaluation of drug release. That is because the drug release is performed before inhalation and the drug is ready to be aerosolized during inhalation.
  • the conformity of the user to these intervals can be monitored by means of the attachment (1). Therefore, the time information related to the usage can be saved and notified to the user or the related healthcare personnel.
  • the time information comprises the date and hour the attachment (1) is used.
  • the attachment (1) can also comprise means such as an accelerometer or a gyroscope in order to determine whether the inhaler (2) is held in the correct position during use. Thereby, the angle of the inhaler (2) during different stages such as drug release and inhalation can be determined and compared to the angles required for these stages to be performed correctly. The correct use of the drugs which need to be shaken prior to use can also be detected by the accelerometer.
  • the attachment (1) can also comprise positioning hardware which enables to determine the location of the user. By means of monitoring the location of the user, the conformity of the schedule determined for the regularly used drugs to the user's daily life can be developed or the reason behind the user's need for the drugs can be determined if necessary.
  • the attachment (1) comprises at least one connection device in order to send data and notifications to external devices such as a smartphone.
  • the connection device is preferably compatible with at least one of the common wireless connection types such as Bluetooth or Wi-Fi.
  • the connection device can be compatible with cabled connection types instead of wireless connection types or with both cabled and wireless connection types.
  • the attachment (1) can comprise at least one indicator (9) which is located on the body (7) and which provides instructions and feedbacks related to the usage.
  • the indicator (9) can be composed of at least one LED and/or screen.
  • the instructions and feedbacks can be presented to the user by means of changing the color and/or intensity of one LED or activating more than one LED linked with different specifications regarding use. Symbols explaining the meaning of the feature can be found next to or on the LED's linked with different features of use. For example, while the LED's related to the angle and inhalation rate provide feedback to the user in order to prompt a change, a LED related to the duration of the inhalation can instruct the user to continue or end the application. Instructions and feedbacks can be presented to the user by means of a real time graphic that shows text, animations, symbols or the flow of air.
  • the attachment (1) used with a dry powder inhaler (2) comprises arms (8) which partially overlap with the buttons (5) of the drug release mechanism in the inhaler (2) and which move according to the body (7) as the user presses the buttons (5).
  • Arm movement sensors which determine the movement of the arms (8) according to the body (7) have been provided. Bu means of these arm movement sensors, it can be determined that the drug release mechanism is triggered.
  • the mentioned arm movement sensors can be potentiometers at the connection points of the arms (8) with the body (7), a circuit which detects the interaction between the electrical, magnetic, infrared or ultrasonic components positioned opposite to each other on the arm (8) and the body (7), or a component which measures the force created on itself with the movement of the arm (8) according to the body (2), which is located on the arms (8) or at the point where the arms (8) are connected to the body (7).
  • the arms (8) can move angularly around the point the arms (8) are connected to the body (7) or in a linear form according to this point.
  • the arms provide the fastening of the attachment (2) to the inhaler (1). Therefore, the distance between the internal points of the opposite arms (8) is shorter than the distance between the external points of the opposite buttons (5). At the internal part of the arms (8), recesses fitting on the buttons (5) are present. In this manner, the attachment (1) fastened onto the inhaler (2) can be fixed by means of flexing the arms (8).
  • the attachment (1) also comprises a power source which enables the sensors, processor, connection device and the indicators (9) to operate.
  • the power source comprises a battery housing which contains one or more than one battery, a charging device which provides for the batteries to be charged with the battery housing, and one or more than one element which provide the supply of electrical energy such as a wireless power transmission device which is connected to an external source without contact.
  • the attachment (1) when it is in a standby mode in which the vibration sensor is not activated, the attachment (1) becomes activated after the drug release mechanism is determined to have been triggered by arm movement sensors. Thereby, it is provided that the attachment (1) is operated with all of its elements only during the drug intake, the energy consumption of the attachment (1) is decreased and the data compiled and transmitted by the attachment (1) is cleared from redundant input.
  • the vibration sensor can be brought to the standby mode again after a predefined period has passed following its activation or it is detected that the user performed the drug release and the air flow has ended.
  • the method of the invention can comprise the step of initiating the measurement (117) before the beginning of inhalation is detected.

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  • Health & Medical Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Anesthesiology (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Pulmonology (AREA)
  • Biophysics (AREA)
  • Biomedical Technology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Hematology (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Medicinal Preparation (AREA)

Abstract

L'invention concerne un procédé de surveillance de l'utilisation d'un inhalateur qui surveille l'utilisation correcte d'un inhalateur destiné à administrer un médicament aux poumons. Le procédé comprend la détermination d'un segment de début de la durée d'inhalation, permettant une évaluation plus détaillée des paramètres correspondant à la libération de médicament et au débit. L'invention concerne aussi la manière de mettre en oeuvre le procédé objet de l'invention au moyen d'une fixation d'inhalateur ou d'un inhalateur.
PCT/TR2019/050141 2018-03-16 2019-03-06 Procédé de surveillance d'utilisation d'un inhalateur Ceased WO2019212442A2 (fr)

Applications Claiming Priority (4)

Application Number Priority Date Filing Date Title
TR2018/03793 2018-03-16
TR2018/03794 2018-03-16
TR2018/03793A TR201803793A2 (tr) 2018-03-16 2018-03-16 İnhalatör eklenti̇si̇
TR201803794 2018-03-16

Publications (2)

Publication Number Publication Date
WO2019212442A2 true WO2019212442A2 (fr) 2019-11-07
WO2019212442A3 WO2019212442A3 (fr) 2020-01-23

Family

ID=68385974

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/TR2019/050141 Ceased WO2019212442A2 (fr) 2018-03-16 2019-03-06 Procédé de surveillance d'utilisation d'un inhalateur

Country Status (1)

Country Link
WO (1) WO2019212442A2 (fr)

Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN119080211A (zh) * 2024-10-09 2024-12-06 深圳市盘龙环境技术有限公司 一种用于厨余制备的VFAs的污水系统投加装置

Family Cites Families (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
PE20020074A1 (es) * 2000-06-23 2002-02-05 Norton Healthcare Ltd Sistema dosificador para inhalador de medicamento
AU2014311969B2 (en) * 2013-08-30 2019-04-04 Adherium (Nz) Limited A compliance monitor for a medicament inhaler
EP3220986B1 (fr) * 2014-11-20 2022-11-09 Cognita Labs, LLC Appareil destinés à mesurer, faciliter et corriger l'utilisation d'inhalateurs
US20190105450A1 (en) * 2015-09-25 2019-04-11 Adherium (Nz) Limited Adherence monitor for a medicament inhaler

Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN119080211A (zh) * 2024-10-09 2024-12-06 深圳市盘龙环境技术有限公司 一种用于厨余制备的VFAs的污水系统投加装置

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