Method for estimating the inhaled dose of a user

Abstract

The invention relates to a method for estimating an inhaled dose of a medicament when delivered to a user by an inhaler (12, 52). A predicted inhaled dose (PID) of the medicament is estimated from at least one first type parameter and at least one second type parameter. The first type parameter is related to a breathing pattern of the user and the second type parameter is related to the inhaler (12, 52).

Description

Technical Field

[0001] This invention relates to a method for estimating a patient's inhaled dose, and more particularly to a method for estimating the inhaled dose based on different types of parameters. Background Technology

[0002] An inhaler is a medical device used to deliver medication through the user's breathing. This allows the medication to be delivered to the lungs and absorbed, enabling targeted medical treatment to specific areas of the body and reducing the side effects of oral medications. There are many types of inhalers, such as metered-dose inhalers, dry powder inhalers, and nebulizers.

[0003] For example, nebulizers deliver medication to the lungs in a mist form to treat asthma, cystic fibrosis, chronic obstructive pulmonary disease (COPD), and other respiratory illnesses or conditions. Nebulizers refine solutions and suspensions into small aerosol droplets, which are mixtures of gaseous and solid or liquid particles, and are inhaled by the patient.

[0004] The actual amount of medication delivered to a user's respiratory tract via an inhaler may differ significantly from the amount initially consumed by the aerosol. For example, the amount of medication delivered as aerosol droplets may be affected by different breathing patterns in different individuals. To more effectively utilize inhalers for the treatment of respiratory illnesses, it is crucial to accurately estimate the inhaled dosage of the medication, taking into account various parameters. Summary of the Invention

[0005] A method for estimating the inhaled dose when delivering a drug to a user using an inhaler is disclosed. The estimated predicted inhaled dose (PID) of the drug is based on at least one first-type parameter and at least one second-type parameter. The first-type parameter relates to the user's breathing pattern, and the second-type parameter relates to the inhaler.

[0006] In one embodiment, the first type of parameter may include the user's inhalation time or the user's exhalation time. The second type of parameter may include the amount of drug deposited in the inhaler's inlet path or the amount of drug residue in the inhaler's outlet path. The predicted inhaled dose can be estimated according to the following formula: PID = (TD - RC) * (I / (E + I)) - DP + RP, where TD is the total amount of drug in the nebulizer of the inhaler, RC is the amount of drug residue in the nebulizer, I is the user's inhalation time, E is the user's exhalation time, DP is the amount of drug deposited in the inhaler's inlet path, and RP is the amount of drug residue in the inhaler's outlet path.

[0007] In one embodiment, a first type of parameter can be obtained by measuring the user's breathing pattern, and a second type of parameter can be obtained from a lookup table based on the type of inhaler.

[0008] The present invention also discloses a device for estimating an inhaled dose when delivering a medication to a user using an inhaler. The device includes a processor and a memory. The memory stores instructions for the processor to execute to perform the following steps: acquiring a first type of parameter related to the user's breathing pattern, acquiring a second type of parameter related to the inhaler, and estimating a predicted inhaled dose of the medication based on the first type of parameter and the second type of parameter. A non-transitory storage medium is also disclosed, on which instructions for estimating the inhaled dose when delivering a medication to a user using an inhaler are stored.

[0009] When a medication is delivered to a user using an inhaler, another user measures that user's breathing pattern and inputs information related to the inhaler type. The inhaled dose is determined based on the predicted inhaled dose of the medication, wherein the expected inhaled dose of the medication is estimated based on a first type of parameter related to the user's breathing pattern and a second type of parameter related to the inhaler. Attached Figure Description

[0010] The structures and technical means adopted by the present invention to achieve the above and other objectives can be understood with reference to the following detailed description and accompanying drawings of preferred embodiments, wherein:

[0011] Figure 1 This is a schematic diagram of a system for estimating a user's inhaled dose according to an embodiment of the present invention.

[0012] Figure 2A This is for Figure 1 A schematic diagram of the inhaler system.

[0013] Figure 2B This is for the purpose of Figure 1 A schematic diagram of another inhaler used in the system shown.

[0014] Figure 3 This is a line graph of recorded data for a real-world breathing pattern, used as an example.

[0015] Figure 4 This is a bar chart comparing the predicted inhaled dose (PID) and the actual inhaled dose (AID) for two tests on two different individuals.

[0016] Figure 5 This is another comparative bar chart of PID and AID for three test subjects using three different inhalers.

[0017] Figure 6 This is a line graph of recorded data for another example of a measured breathing pattern.

[0018] Figure 7This is another comparative bar chart of PID and AID for two tests conducted on two different individuals.

[0019] Figure 8 This is a schematic diagram of another system for estimating a user's inhaled dose according to an embodiment of the present invention. Detailed Implementation

[0020] System Overview

[0021] like Figure 1 As shown, a system 1 for estimating a user's inhaled dose according to one embodiment includes a breathing module 11, an inhaler 12, and an analyzer 13. The breathing module 11 may be a pressure sensor or flow sensor for measuring the user's breathing pattern, such as the user's tidal volume (Vt), inspiratory time (I), and expiratory time (E). The breathing module 11 may be disposed within a flow loop.

[0022] like Figure 2A As shown, the inhaler 12 includes a three-way connector comprising an aerosol inlet 121, an inlet path 122, an outlet path 123, a filter 124, and a patient port 125. The aerosol inlet 121 is detachably attached to an aerosol initiation location, such as an aerosol generator 126 that produces aerosol droplets entering the inhaler 12. The aerosol inlet 121 may also be detachably connected to the outlet of a nebulizer that produces aerosol droplets. Other aerosol generation sources, such as metered-dose inhalers or jet nebulizers, may also be connected to the aerosol inlet 121.

[0023] A filter 124, such as a high-efficiency particulate air filter or a respiratory circuit bacterial filter (VF-2160), is detachably connected between the inlet path 122 and the patient port 125 to filter out aerosol droplets in the airflow flowing into and out of the patient port 125. The amount of medication deposited in the filter 124 indicates the actual dose of medication inhaled by the user when breathing through the patient port 125.

[0024] The patient port 125 can be, for example, a mouthpiece, face mask, breathing cannula, or any other device that delivers aerosol droplets into the patient's airway. When the filter 124 is disconnected from the inlet path 122, the patient port 125 can be connected to the inlet path 122, with the filter 124 not positioned between them. That is, the patient can use the inhaler 12 to inhale his or her medication directly in the form of aerosol droplets without having to filter the medication through the filter 124.

[0025] The aerosol generator 126 can be a portable nebulizer having a container for containing medication and a vibrating module that converts the medication in the container into tiny droplets for inhalation therapy. The aerosol generator 126 can be connected directly or via other means such as tubing to the aerosol inlet 121.

[0026] Furthermore, the inhaler 12 can be modified in its construction according to the specific application. For example, as... Figure 2B As shown, the inlet path 122 and outlet path 123 may not be arranged in a straight line, but rather perpendicular to each other. The aerosol generator 126 is an atomizer that is fluidly connected to the aerosol inlet 121 via a tube. Those skilled in the art can use different types of aerosol generators with different constructions.

[0027] The analyzer 13 can be a general-purpose computer or a device with a computing chip, such as a central processing unit or microprocessor equipped with software for estimating the inhaled dose. The analyzer 13 can receive measurements of the user's breathing pattern from the breathing module 11 and estimate the inhaled dose based on the breathing pattern and other parameters. For example, the analyzer 13 can receive data via wired transmission (e.g., Universal Sequential Bus cable) or wireless transmission (e.g., Bluetooth Low Energy or Wi-Fi). After receiving data from the breathing module 11, the analyzer 13 can display the data on a monitor via a user graphical interface, allowing the operator to view the user's breathing pattern in real time. The analyzer 13 can also receive operator input via the user graphical interface, such as the type of inhaler 12.

[0028] Example 1

[0029] Figure 3 An example of a breathing pattern measured by breathing module 11 is shown. Personnel A uses Microbase at patient port 125. -T3 was inhaled, and the nebulization rate of salbutamol aerosol was 0.55 ml / min (5 mg / 2.5 ml).

[0030] Analyzer 13 estimates the predicted inhaled dose (PID) according to the following equation (1):

[0031] PID = (TD-RC)*(I / (E+I)) - DP + RP (1)

[0032] Where TD is the total drug amount, RC is the drug residue in the aerosol generator 126, I is the inhalation time, E is the exhalation time, DP is the parameter of drug deposition in the inhaler 12, and RP is the parameter of drug residue in the inhaler 12.

[0033] Of the parameters above, TD and RC can be obtained through operator input after checking the aerosol generator 126 connected to the aerosol inlet 121. I and E can be obtained from the breathing module 11. DP and RP are related to the type of inhaler 12 and can be obtained from a lookup table stored in the memory of the analyzer 13 after the operator inputs the inhaler type. The analyzer 13 selects the device parameters based on the type of inhaler 12 input by the operator and the breathing parameters output by the breathing module 11. Table 1 is an example of a lookup table:

[0034]

[0035] The operation is described below. After setting up system 1, the operator first inputs the type of inhaler 12 and the total aerosol medication from aerosol generator 126. Analyzer 13 retrieves parameters DP and RP from a lookup table based on the input inhaler type. Then, the operator instructs person A to begin breathing using the patient port 125 of inhaler 12. The breathing module 11 then measures person A's breathing pattern, including inspiratory time I and expiratory time E, and outputs I and E to analyzer 13. Figure 3 It is a waveform-based breathing pattern. After a predetermined time, the operator instructs personnel A to stop breathing using patient port 125 and inputs the residual amount in aerosol generator 126 into analyzer 13. Then, analyzer 13 calculates the PID according to the above equation (1).

[0036] In other cases, specific parameters DP and RP can be pre-set for a particular inhaler 12 in analyzer 13. The operator does not need to input the inhaler type, but only needs to measure the breathing pattern of analyzer 13 to calculate the patient's PID. Analyzer 13 can also store preset residual doses. The operator also does not need to input the residual dose into aerosol generator 126.

[0037] The operator then removes the filter 124 from the inhaler 12 and checks the amount of medication deposited on the filter 124 to obtain the actual inhaled dose (“AID”) of person A. Figure 4 The comparison of PID and AID for two tests conducted on two different individuals is shown. Figure 4 In this study, test subject 1 was female, and test subject 2 was male. The PID (Physical Intake) of female test subject 1 was 37.40% of the medication atomized by the aerosol generator, while the PID of male test subject 2 was 33.70%. Figure 4 As shown, regardless of gender, both PIDs are close to their corresponding AIDs, at 40.91% and 36.76%, respectively.

[0038] Figure 5Another comparison of PID and AID for different detectors (detector 1, detector 2, detector 3) using different inhalers (inhaler 1, inhaler 2, inhaler 3) is shown. Figure 5 As shown, although the AID varies significantly depending on the inhaler used, the PID is still close to the AID of the inhaler because a second type of parameter is added when estimating the PID to account for the different characteristics of the inhaler. Therefore, a more accurate PID can be obtained.

[0039] Example 2

[0040] Figure 6 Another example of a breathing pattern measured by breathing module 11 is shown. Person B breathes using another nebulizer, with the nebulized salbutamol aerosol (5 mg / 2.5 ml) at patient port 125 at a rate of 0.3 ml / min. Analyzer 13 estimates the PID according to equation (1) above.

[0041] Figure 7 The comparison of PID and AID after two tests is shown. Figure 7 In the study, the PID of Test 1 was similar to the AID of the patient in Test 1, while the PID of Test 2 was similar to the AID of the patient in Test 2.

[0042] Use Cases

[0043] Figure 8 Another system 5 is shown, which includes a breathing module 51, a device 52, and an analyzer 53. System 5 is related to... Figure 1 The system shown is largely the same as system 1, except that a filter for measuring the actual inhaled dose is not installed between the inlet path 522 of the inhaler 52 and the patient port 525. Figure 1 The inhaler shown is the same.

[0044] After establishing system 5, the operator first inputs the type of device 52. Analyzer 53 retrieves parameters DP and RP from a lookup table based on the inhaler type input by the operator. Then, the operator turns on the nebulizer 526 and instructs patient C to begin breathing using the patient port 525 of device 52. The breathing module 51 then begins to measure parameters of patient C's breathing pattern in real time and outputs these parameters to analyzer 53.

[0045] After a predetermined period of time, analyzer 53 calculates the PID of patient C. This PID can be displayed to the doctor for reference. The doctor can adjust the flow rate of nebulizer 526 in real time based on the PID to more effectively deliver the medication in aerosol form to patient C.

[0046] This disclosure has been described through some preferred embodiments, and it should be understood that the preferred embodiments are merely illustrative and are not intended to limit the invention in any way. Many changes and modifications can be made to the described embodiments without departing from the scope and spirit of the invention, which is intended to be limited only by the appended claims.

Claims

1. A device for estimating the inhaled dose of a user when delivering a drug to the user via an inhaler, comprising: processor; as well as Memory on which instructions are stored, wherein the processor is capable of executing the instructions to accomplish the following steps: Obtain a first type of parameter, which includes the user's inhalation time and the user's exhalation time; Obtain a second type of parameter, which includes the amount of drug deposited in the inlet path of the inhaler and the amount of drug residue in the outlet path of the inhaler; as well as The predicted inhaled dose of the drug is estimated based on the first type parameter and the second type parameter; The predicted inhaled dose is estimated using the following formula: PID = (TD-RC) (I / (E+I)) + (DP - RP) Wherein, TD is the total amount of drug in the nebulizer of the inhaler, RC is the amount of drug residue in the nebulizer, I is the user's inhalation time, E is the user's exhalation time, DP is the amount of drug deposited in the inhaler's inlet path, and RP is the amount of drug residue in the inhaler's outlet path.

2. The device according to claim 1, wherein, This first type of parameter is obtained by measuring the user's breathing pattern.

3. The device according to claim 1, wherein, The second type parameter is obtained from a lookup table based on the type of inhaler.

4. A non-transitory storage medium storing instructions for estimating the inhaled dose when a drug is delivered to a user using an inhaler, wherein, The processor is able to execute this instruction to perform the following steps: Obtain a first type of parameter, which includes the user's inhalation time and the user's exhalation time; Obtain a second type of parameter, which includes the amount of drug deposited in the inlet path of the inhaler and the amount of drug residue in the outlet path of the inhaler; as well as The predicted inhaled dose of the drug is estimated based on the first type parameter and the second type parameter; The predicted inhaled dose is estimated using the following formula: PID = (TD-RC) (I / (E+I)) + (DP - RP) Wherein, TD is the total amount of drug in the nebulizer of the inhaler, RC is the amount of drug residue in the nebulizer, I is the user's inhalation time, E is the user's exhalation time, DP is the amount of drug deposited in the inhaler's inlet path, and RP is the amount of drug residue in the inhaler's outlet path.

5. The non-transitory storage medium according to claim 4, wherein, This first type of parameter is obtained by measuring the user's breathing pattern.

6. The non-transitory storage medium according to claim 4, wherein, The second type parameter is obtained from a lookup table based on the type of inhaler.

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