CN115887836A - Respiratory drug delivery device and drug delivery automation method - Google Patents

Abstract

The invention discloses a respiratory drug delivery device and an automatic method for drug delivery. The respiratory drug delivery device is used to deliver a drug to the respiratory tract of a patient, and mainly includes an inhalation piece, a trachea, and a sound sensor , and a drug delivery module, the drug delivery module outputs an atomized drug at least when the patient inhales according to a sound signal sensed by the sound sensor.

Description

Respiratory drug delivery device and automated drug delivery method

Technical Field

The present invention relates to a respiratory drug delivery device and an automated drug delivery method, and in particular to a respiratory drug delivery device for intermittent drug delivery and an automated method for delivering a drug to a patient's respiratory tract using the respiratory drug delivery device.

Background Art

At present, the mist therapy devices used in clinical respiratory therapy usually adopt a continuous aerosol supply method. Even when the patient is in the exhalation state, the aerosol-state drug is continuously supplied. Therefore, the drug delivery efficiency is poor. Generally, only 20% to 30% of the drug enters the patient's body through the respiratory tract, and the rest of the drug cannot be used, resulting in a serious waste of drugs.

Therefore, there is an urgent need for a novel mist therapy device that can detect the patient's breathing time for patients of different ages or different disease types, and accurately administer medication at the appropriate breathing time point to improve the delivery efficiency of aerosol drugs.

Summary of the invention

The present invention provides a respiratory drug delivery device for delivering a drug to the respiratory tract of a patient, comprising: an inhalation device; an air supply pipe connected to the inhalation device; a sound sensor arranged in the air supply pipe and detecting a wind sound of the patient's breathing to generate a sound signal; and a drug delivery module connected to the air supply pipe and the sound sensor, the drug delivery module is used to atomize the drug into an atomized medicine and output it to the air supply pipe; wherein the drug delivery module outputs the atomized medicine according to the sound signal at least when the patient inhales.

In one embodiment, the sound signal includes a plurality of respiratory cycles, and each respiratory cycle sequentially includes an inhalation segment, a rest segment, and an exhalation segment, and the drug delivery module outputs the atomized medicament at least in the inhalation segment.

In one embodiment, the drug delivery module outputs the aerosolized medicament from 0.1 to 5 seconds before the start of the inhalation segment to the end of the inhalation segment.

In one embodiment, the drug delivery module outputs the atomized medicament 0.1 to 5 seconds before the start of the inhalation segment and 0.5 to 3 seconds before the end of the inhalation segment.

In one embodiment, the aerosolized medicament is a micronized drug, a water-soluble drug, or a drug suspension that is aerosolized.

In one embodiment, the drug delivery module comprises a nebulizer for generating the aerosolized medicament.

In one embodiment, the atomization aperture of the atomized medicine is less than 10 μm.

In one embodiment, the nebulizer is an ultrasonic oscillation nebulizer.

In one embodiment, the inhalation device is a nasal mask, a mouthpiece, or a nasal cannula.

The respiratory drug delivery device provided by the present invention can be connected to an existing respirator, and while assisting the patient's breathing, atomized drugs can be delivered simultaneously for respiratory tract treatment.

The present invention also provides an automated drug delivery method for delivering a drug to the respiratory tract of a patient, and the steps mainly include: Step 1: providing a respiratory drug delivery device, which includes an inhalation component, an air supply tube, connected to the inhalation component, a sound sensor, arranged in the air supply tube, and a drug delivery module, outputting an atomized drug to the air supply tube; Step 2: the air supply tube obtains the patient's respiratory airflow through the inhalation component, and senses the wind sound of the respiratory airflow with the sound sensor to generate a sound signal; Step 3: judging the patient's respiratory cycle through the sound signal, and at least when the patient inhales, the drug delivery module outputs the atomized drug to the air supply tube, and the inhalation component outputs the atomized drug.

In one embodiment, in step 2, the patient has a respiratory frequency of 0.2-1 Hz.

In one embodiment, in step 2, the respiratory airflow is emitted from the patient's nose and delivered to the airway.

In one embodiment, in step 3, the sound signal includes a plurality of respiratory cycles, and each respiratory cycle sequentially includes an inhalation segment, a rest segment, and an exhalation segment, and the drug delivery module outputs the atomized medicament at least in the inhalation segment.

In one embodiment, in step 3, the drug delivery module outputs the aerosolized medicament from 0.1 to 5 seconds before the start of the inhalation segment to the end of the inhalation segment.

In one embodiment, in step 3, the drug delivery module outputs the aerosolized medicament from 0.1 to 5 seconds before the start of the inhalation segment to 0.5 to 3 seconds before the end of the inhalation segment.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG1 is a schematic structural diagram of a respiratory drug delivery device according to an embodiment of the present invention;

FIG2 is a schematic diagram of a sound signal of a breathing simulation device in an embodiment of the present invention;

FIG. 3 is a schematic diagram of a respiratory cycle sound signal of a respiratory simulation device in an embodiment of the present invention.

Reference numerals

1000-Respiratory Drug Delivery Device

1-Suction piece

2-Gas pipeline

3- Sound sensor

4-Dosing module

41-Signal Processor

42-Atomizer

DETAILED DESCRIPTION

In order to make the objectives, technical solutions and advantages of the present invention more clearly understood, the present invention is further described in detail below in conjunction with specific embodiments and with reference to the accompanying drawings.

The following is an explanation of the implementation of the present invention through specific embodiments. Those skilled in the art can easily understand other advantages and effects of the present invention from the contents disclosed in this specification. The present invention can also be implemented or applied through other different specific embodiments, and the details in this specification can also be modified and changed in various ways based on different viewpoints and applications without departing from the spirit of the present invention.

A respiratory medication device 1000 according to an embodiment of the present invention is shown in FIG. 1 , and mainly includes an inhalation device 1 , an air delivery tube 2 , a sound sensor 3 , and a medication module 4 .

In this embodiment, the inhalation device 1 is a nasal mask for covering the patient's mouth and nose. In other embodiments, the inhalation device 1 may be a nasal mask or a nasal catheter. The inhalation device to be used may be determined according to the patient's condition, as long as the inhalation device 1 is connected to the patient's respiratory tract and can obtain the patient's breath.

The air delivery tube 2 is connected to the inhalation device 1, and the sound sensor 3 is a microphone, which is arranged on the inner wall of the air delivery tube 2, and preferably arranged near the inhalation device 1, to collect the wind sound generated by the patient's breathing, and convert the wind sound into a sound signal and transmit it to the drug delivery module. The wind sound of the patient's breathing is generated by the airflow passing through the sound sensor 3 during inhalation and exhalation.

The drug delivery module 4 includes a signal processor 41 and a nebulizer 42. The signal processor 41 receives the sound signal of the patient's breathing detected by the sound sensor 3. After processing, it is determined that the sound signal may include multiple breathing cycles, and each breathing cycle includes an inhalation segment, a stop segment, and an exhalation segment in sequence; and the nebulizer 42 is arranged in the air supply pipe 2, and is preferably arranged at a position away from the inhalation component 1 and the sound sensor 3. The nebulizer 42 outputs an atomized medicine in the inhalation segment, and transmits it to the inhalation component 1 through the air supply pipe 2, so as to be further transmitted to the patient's respiratory tract. That is, when the patient is in the inhalation segment, the atomized medicine can be transmitted from the inhalation component 1 to the patient's respiratory tract, and when the patient is in the exhalation segment, the output of the atomized medicine is stopped, thereby improving the efficiency of drug delivery and avoiding wasting medicine. In detail, the nebulizer is an ultrasonic oscillation nebulizer, which is used to atomize a medicine to produce the atomized medicine, and the medicine can be a micronized drug, a water-soluble drug or a drug suspension, etc., and the atomization aperture of the atomized medicine is less than 10μm.

The respiratory drug delivery device of this embodiment can be further connected to an existing respirator to assist the patient's breathing while administering atomized medicine for respiratory treatment. However, the present invention is not limited thereto and can be configured according to the needs during use.

In another embodiment, the nebulizer 42 can output the atomized medicine from 0.1 to 5 seconds before the start of the inhalation segment to the end of the inhalation segment, that is, it can start outputting the atomized medicine from the last 0.1 to 5 seconds of the exhalation segment until the end of the inhalation segment, so that when the patient starts to inhale, the inhalation device 1 (oronasal mask) is already filled with atomized medicine, which can further improve the efficiency of drug administration.

In another embodiment, the nebulizer 42 starts to output the atomized medicine in the last 0.1 to 5 seconds of the exhalation segment, and stops outputting the atomized medicine 0.5 to 3 seconds before the end of the inhalation segment. Such a drug administration time allows the inhalation component 1 to be filled with atomized medicine when the patient starts to inhale, and stopping the drug supply before the end of the inhalation segment can avoid excessive residual atomized medicine filling the inhalation component at the beginning of the exhalation segment, thereby increasing the drug administration efficiency and avoiding drug waste.

The following is a detailed description of an automated method for drug delivery using the respiratory drug delivery device 1000 provided by the present invention. The method is to deliver a drug to the respiratory tract of a patient, and the steps are as follows:

Step 1: Provide a respiratory drug delivery device, which includes an inhalation device, an air delivery tube connected to the inhalation device, a sound sensor disposed in the air delivery tube, and a drug delivery module that outputs an atomized drug to the air delivery tube. In detail, the respiratory drug delivery device and the above-mentioned respiratory drug delivery device have a component structure as described above.

Step 2: The air supply tube obtains the patient's respiratory airflow through the suction piece, and senses the wind sound of the respiratory airflow with the sound sensor to generate a sound signal. In this embodiment, the respiratory airflow is emitted from the patient's nose and transmitted to the air supply tube. The sound sensor is arranged in the air supply tube to sense the wind sound of the respiratory airflow. This can prevent the sound sensor from being too close to the patient and receiving the patient's heartbeat or noise emitted by other medical equipment. Therefore, it can ensure that the inhalation segment, a stop segment, and the exhalation segment in the sound signal generated by the sound sensor are correct. In addition, generally speaking, a patient's respiratory frequency is usually 0.2 to 1 Hz. If the respiratory frequency of the sound signal exceeds this range, it may be necessary to check whether the sound sensor senses noise other than the respiratory wind sound, or whether the instrument may be faulty.

Step 3 determines the patient's breathing cycle through the sound signal, and at least when the patient inhales, the drug delivery module outputs the atomized medicine to the air pipe, and the atomized medicine is output by the inhalation part. In detail, when the patient is in the inhalation stage, the drug delivery module transfers the atomized medicine from the inhalation part to the patient's respiratory tract, and stops outputting the atomized medicine when the patient is in the exhalation stage, thereby improving the efficiency of drug delivery and avoiding waste of medicine. Similarly, in another embodiment, the drug delivery module outputs the atomized medicine from 0.1 to 5 seconds before the start of the inhalation stage to the end of the inhalation stage; and in another embodiment, the drug delivery module outputs the atomized medicine from 0.1 to 5 seconds before the start of the inhalation stage to 0.5 to 3 seconds before the end of the inhalation stage, thereby further increasing the drug delivery efficiency and avoiding waste of medicine.

Evaluation of drug administration efficiency This embodiment uses a breathing simulator to simulate the patient's breathing, and is connected to the breathing drug administration device provided by the present invention through the inhalation component. The breathing simulator is used to simulate the normal breathing conditions of healthy patients, and has a ventilation tube connected to the breathing drug administration device. A filter paper is also provided in the ventilation tube to absorb the atomized medicine. The weight of the medicine absorbed on the filter paper is used to evaluate the drug administration efficiency. The setting parameters of the breathing simulator are as follows: the inhalation/exhalation ratio (I/E ratio) is 1/2.5; the volume of air inhaled or exhaled in each breathing cycle is 410mL; and the total amount of water is 1mL. The breathing drug administration device uses water simulation as the medicine, and it becomes water mist after atomization.

When the breathing simulated by the breathing simulator enters the airway through the inhalation part, the sound signal generated after the sound sensor senses the wind noise is shown in Figure 2, and the sound signal of a breathing cycle is shown in Figure 3. It can be seen from the figure that the inhalation segment lasts for 1.35 seconds, the exhalation segment lasts for 3 seconds, and there is a short stop segment between the inhalation segment and the exhalation segment. This evaluation has six groups of embodiments, namely, Embodiment 1 to Embodiment 6. In Embodiment 1 to Embodiment 6, the drug delivery device transfers the atomized medicine (water mist) to the airway and enters the ventilation tube of the breathing simulation device within 1.35 seconds of the inhalation segment, and is adsorbed onto the filter paper along with the simulated inhalation airflow. The weight of the filter paper is measured before the drug is input and after the drug is sprayed dry, and then converted into drug delivery efficiency, and the formula is:

Drug administration efficiency (%) = (weight of filter paper after drug administration - weight of filter paper before drug administration) / total weight of water.

In addition, 8 groups of comparative examples (Comparative Examples 1 to Comparative Examples 8) in this evaluation were tested in a continuous dosing manner, and the weight of the filter paper was measured before and after the drug was injected to convert its dosing efficiency, and the dosing efficiency of the embodiment and the comparative example was compared. The results of this evaluation are shown in Table 1 below:

Table 1

It is obvious from the evaluation results in Table 1 that the drug administration efficiency of Examples 1 to 6, which control drug administration only during the inhalation phase, is significantly higher than that of Comparative Examples 1 to 8, which control drug administration continuously. This proves that the respiratory drug administration device provided by the present invention can indeed increase drug administration efficiency.

Next, the setting parameters of the breathing simulator are changed as follows: the inhalation/exhalation ratio (I/E ratio) is 1/2.5; the air volume inhaled or exhaled in each breathing cycle is 250mL, 500mL, and 800mL; and the total amount of water is 1mL, to simulate the drug being used as a medicine and becoming water mist after atomization. Similarly, the drug delivery device transfers the atomized drug (water mist) to the air pipe and enters the ventilation tube of the breathing simulation device within 1.35 seconds of the inhalation segment, and measures the weight of the filter paper set in the ventilation tube before and after the drug input, and then converts it into drug delivery efficiency. In detail, the embodiment in this evaluation only transfers the atomized drug (water mist) to the air pipe and enters the ventilation tube of the breathing simulation device within 1.35 seconds of the inhalation segment, while the comparative example is tested in a continuous drug delivery manner. The evaluation of 250mL air volume has three groups of embodiments and three groups of comparative examples, which are embodiments 7 to 9 and comparative examples 9 to 11; the evaluation of 500mL air volume has three groups of embodiments and three groups of comparative examples, which are embodiments 10 to 12 and comparative examples 12 to 14; the evaluation of 800mL air volume also has three groups of embodiments and three groups of comparative examples, which are embodiments 13 to 15 and comparative examples 15 to 17. The results of this evaluation are shown in Table 2 below:

Table 2

From the evaluation results shown in Table 2, it can be seen that the drug administration efficiency of intermittent administration is still significantly higher than that of continuous administration, with a drug administration efficiency as high as 50 to 75%.

Next, the breathing of patients with chronic obstructive pulmonary disease (COPD) of different degrees was simulated, including severe COPD, mild COPD, common COPD, and interstitial lung disease (ILD). The total amount of water in this evaluation was 1 mL, the air volume was 500 ml, and the setting parameters of other breathing simulators (inhalation/expiration ratio and resistance), the groups of the embodiments and comparative examples, and the evaluation results are shown in Table 3:

Table 3

According to the evaluation results shown in Table 3, when the breathing simulator simulates COPD and ILD of different degrees, the intermittent drug administration mode in the inhalation stage can still significantly improve the drug administration efficiency by 2 to 3 times. Therefore, the respiratory drug administration device provided by the present invention can improve the utilization rate of the atomized drug entering the patient's body through the respiratory tract, significantly improving the drug waste problem of continuous drug administration, and the respiratory drug administration device provided by the present invention uses the wind sound of the patient's breathing as the standard for judging the patient's breathing condition, and the sound sensor is arranged in the airway, so it is not easily affected by the patient's heartbeat or other noises in the ward, and can accurately judge the patient's breathing frequency and thus intermittently administer the drug.

Claims (15)

1. A respiratory drug delivery device for delivering a drug to the respiratory tract of a patient, comprising: a suction member; an air delivery pipe connected to the suction member; a sound sensor disposed in the air supply tube and detecting a wind sound of the patient's breathing to generate a sound signal; and a drug delivery module connected to the air delivery tube and the sound sensor, the drug delivery module is used to atomize the drug into an atomized medicament and output it to the air delivery tube; The drug delivery module outputs the atomized medicine at least when the patient inhales according to the sound signal. 2. The respiratory drug delivery device according to claim 1 is characterized in that the sound signal includes multiple respiratory cycles, and each respiratory cycle sequentially includes an inhalation segment, a stop segment, and an exhalation segment, and the drug delivery module outputs the atomized drug at least in the inhalation segment. 3 . The respiratory drug delivery device according to claim 2 , wherein the drug delivery module outputs the atomized drug from 0.1 to 5 seconds before the start of the inhalation segment to the end of the inhalation segment. 4. The respiratory drug delivery device according to claim 3, characterized in that the drug delivery module outputs the atomized drug from 0.1 to 5 seconds before the start of the inhalation segment to 0.5 to 3 seconds before the end of the inhalation segment. 5 . The respiratory drug delivery device according to claim 1 , wherein the atomized drug is a micronized drug, a water-soluble drug, or a drug suspension that is atomized. 6. The respiratory drug delivery device according to claim 5, characterized in that the drug delivery module comprises a nebulizer for generating the atomized drug. 7. The respiratory drug delivery device according to claim 5, characterized in that the atomization aperture of the atomized medicine is less than 10 μm. 8. The respiratory drug delivery device according to claim 6, wherein the nebulizer is an ultrasonic oscillation nebulizer. 9. The respiratory drug delivery device of claim 1, wherein the inhalation member is a nasal mask, a mouthpiece, or a nasal catheter. 10. An automated drug delivery method for delivering a drug to the respiratory tract of a patient, comprising: Step 1: Provide a respiratory drug delivery device, which includes an inhalation device, an air delivery tube connected to the inhalation device, a sound sensor disposed in the air delivery tube, and a drug delivery module that outputs an atomized drug to the air delivery tube; Step 2: The air supply tube obtains the patient's respiratory airflow through the suction component, and the sound sensor senses the wind noise of the respiratory airflow to generate a sound signal; Step 3: Determine the patient's breathing cycle through the sound signal, and at least when the patient inhales, the drug delivery module outputs the atomized medicine to the air supply pipe, and the atomized medicine is output by the inhalation component. 11. The automated drug delivery method according to claim 10, wherein in step 2, a respiratory frequency of the patient is 0.2-1 Hz. 12. The automated drug delivery method according to claim 11, wherein in step 2, the respiratory airflow is emitted from the patient's nose and delivered to the airway. 13. The automated drug delivery method according to claim 10, characterized in that in step 3, the sound signal includes multiple breathing cycles, and each breathing cycle sequentially includes an inhalation segment, a stop segment, and an exhalation segment, and the drug delivery module outputs the atomized drug at least in the inhalation segment. 14. The automated drug delivery method according to claim 13, characterized in that in step 3, the drug delivery module outputs the atomized drug from 0.1 to 5 seconds before the start of the inhalation segment to the end of the inhalation segment. 15. The automated drug delivery method according to claim 13, characterized in that in step 3, the drug delivery module outputs the atomized medicine between 0.1 to 5 seconds before the start of the inhalation segment and 0.5 to 3 seconds before the end of the inhalation segment.

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