Droplet delivery device with high dose confidence mode

Abstract

A droplet delivery device includes a high dose confidence mode that monitors a user's inhalation of a composition and activates and deactivates aerosol generation by monitoring the user's inhalation when the user does not inhale a full dose of the composition while using the device to assist the user in full dose administration.

Description

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS

[0002] This application claims priority to U.S. Provisional Application No. 63 / 437,909, filed on January 9, 2023, entitled “Droplet Delivery Device with High Dose Confidence Mode,” which is incorporated herein by reference in its entirety. Technical Field

[0003] The present disclosure relates to droplet delivery devices, and more particularly, to droplet delivery devices for delivering fluids for inhalation into the mouth, throat, nasal cavity, and / or lungs. While the present disclosure is particularly directed to the delivery of therapeutic compositions, in some embodiments, non-therapeutic compositions capable of being aerosolized may also be used. Background Art

[0004] This application incorporates by reference the contents of WO2020 / 264501 (describing “annular mode” injection), PCT / US2022 / 034552 (describing “push mode” injection), U.S. Patent No. 10,449,314 (describing dose verification) and U.S. Patent Application Publication No. 20190134330 (describing user feedback and instructions) in their entirety.

[0005] There is a need for a droplet delivery device, such as those described in the patent publication cited by the applicant, to measure the patient's dose throughout the administration / inhalation process to provide a high-dose confidence model that the appropriate dose was administered to the patient. Specifically, the present invention can determine if the patient did not initially receive a full dose, then the device calculates the remaining dose and issues a voice command, visual notification, or similar communication to the patient to inhale again to complete the dose. Summary of the Invention

[0006] The droplet delivery device of the present invention, such as a droplet delivery device for inhaled drugs, pharmaceuticals, biologics, vaccines, and other therapeutic substances, uses a differential pressure sensor to measure the user's inhalation profile during a dose administration process. In some embodiments, the droplet delivery device includes a Sensirion SDP3x with a pressure update rate of 0.5 milliseconds and an accuracy of 0.1 Pa. TM Sensors (available from Laubis ruetis tras se 50,8712 The company acquired the device from Sensirion AG of Switzerland, whose U.S. branch is Sensirion Connected Solutions Inc., located at 11 East Adams Suite 220, Chicago, IL 60603, to measure the user's inhalation profile in near real time.

[0007] In an embodiment, a user initiates a dose by inhaling from the mouthpiece of a droplet delivery device. After inhalation, the device begins actuating an injector component, such as a piezoelectric element / transducer in combination with a grid or plate with holes, to generate an aerosol—such as the piezoelectric transducer in a "push mode" injector device and the piezoelectric element in a "ring mode" injector device (disclosed herein and incorporated by reference). If the patient stops inhaling from the mouthpiece before their metered dose is complete, the device will stop generating aerosol. The device will then wait until the patient inhales from the mouthpiece to deliver the remaining dose.

[0008] For example, if a user's dose requires 1.5 seconds of inhalation and they stop inhaling halfway at 0.75 seconds, they still need to take the other half of their dose. The droplet device of the present invention senses that the remaining dose has not been completed and stops generating aerosol, then prompts the user that they have not received their full dose and instructs them to inhale from the mouthpiece again. When the user starts spraying for the second time, the device will start generating aerosol and continue until the other half of their dose is inhaled. It should be appreciated that the remaining dose and the aerosol generation time for the remaining amount of the dose can be any difference between the full dose and the amount inhaled by the user during the initial dosing event (e.g., based on time). BRIEF DESCRIPTION OF THE DRAWINGS

[0009] Figure 1 A block diagram illustrating the relationship between the droplet device components and a microcontroller unit (MCU) in one embodiment of the present invention. DETAILED DESCRIPTION

[0010] refer to Figure 1 The MCU 100 reads all switches and sensors and controls all major functions, including piezoelectric waveform generation, dosing and user interface (UI) display, voice prompts, chip ID reading, and user compliance documentation. The main MCU 100 activates and maintains digital power when digital power is activated by the power MCU 175. When the mouth cover is open, the on / off switch 120 can be closed to activate the device's power and prepare it for aerosol generation. A battery tester 135 can also be operably connected to the MCU 100.

[0011] The total inhalation time is determined by the drug application. The droplet device of the present invention meters for a specific drug dispensing rate, and based on this parameter, the total inhalation time can be determined. A predetermined single-dose administration time is then specified in the microcontroller software to provide a high-dose confidence mode. The cartridge ID resistor 110 can provide different resistances to identify different liquid supply cartridges, thereby determining the appropriate dose for the corresponding drug application, including the dispensing rate and inhalation time.

[0012] In some embodiments, drug efficacy can be calculated based on some combination of the instantaneous flow rate from the user and the amount of inhalation time. For example, if the user inhales at a sufficient flow rate for the full dose time, the drug efficacy is 100%. If the user inhales at an insufficient flow rate for the full dose time, the drug efficacy is less than 100%. If the user inhales at a sufficient flow rate for half the dose time, the drug efficacy is 50%. The device can then allow continued administration to deliver the remainder of the dose.

[0013] The timing of the start / stop method is based on the microcontroller's timer program based on the pressure changes measured from the pressure sensor 105. When the system notices a drop in pressure from the user inhaling at the mouthpiece, as sensed by the pressure sensor 105, the droplet delivery device begins actuating the piezoelectric element / transducer via the piezoelectric driver IC 155 and starts a timer via the clock IC 150. After the pressure sensor value sensed from the sensor 105 drops below an acceptable value, the device stops the timer via the clock IC 150 and stops actuating the piezoelectric element / transducer. TM The delay from the user starting to inhale to the device actuating the spray can be less than or equal to 0.5 milliseconds, as measured on the pressure sensor 105. The delay from the start of the dose timer to the actuation of the piezoelectric element is much smaller, in the microsecond range.

[0014] The pressure sensor 105 can be calibrated, for example, using a standard 3 L spirometry syringe as described at http: / / www.a-msys tems.com / p-60-fixed-volume-calibration-syringe.aspx (incorporated herein by reference). The start / stop conditions can be triggered by any of the following (which may help ensure drug delivery to a specific part of the lung):

[0015] (1) a transient pressure threshold—either the user stops inhaling completely or the user is unable to inhale at an adequate flow rate; and

[0016] (2) A threshold value of air volume or some other calculated value may be used as the start / stop condition.

[0017] In some embodiments, a communication or notification can be provided to the user that there is still a remaining dose required to reach a full dose. The user can be prompted to inhale again on the device to complete the administration of the dose, such as by an audio speaker or visual notification in communication with the sound chip 115. The input functions of the voice switch increase 125 and the voice switch decrease 130 allow the user to adjust the volume of the audio from the speaker. The user is provided with a visual notification for conveying user actions and device readiness status through an LED indicator 160, such as a three-color LED, and the power status is notified by a battery LED indicator 165. The LCD driver 170 can display a dose counter or similar indication of the administered dose and / or remaining dose to the user.

[0018] When the user inhales to complete a dose, if a pressure drop is detected again from the pressure sensor, the piezoelectric element / transducer is then activated for the remainder of the dose time (i.e., the remaining amount is delivered to achieve the full dose based on the calculated remaining time remaining to achieve the full dose). After the user completes the remaining inhalation time required to achieve the full dose, the microcontroller will deactivate the piezoelectric element.

[0019] The trickle-charge real-time clock circuit 150 is crucial for Internet of Things (IoT) applications, such as mobile / desktop applications paired via Bluetooth module 140, because it enables accurate tracking of each dose administered in real time. This circuit can use a very small amount of power to keep the clock on the device running even when the device is completely powered off.

[0020] There are at least two alternative approaches for driving the piezoelectric element / transducer. The first alternative utilizes a waveform generated by a boost converter or H-bridge circuit to drive the piezoelectric element / transducer. The second alternative utilizes an autotransformer and MOSFET circuit 180. The operating principles of these two approaches are similar, as the frequency of the waveform applied to the piezoelectric element / transducer is determined by pulse-width modulation (PWM) by a microcontroller or a frequency generated by a separate integrated circuit. The difference between these two alternatives lies in how the high voltage (>30V) is generated. The start of injection, or activation of the piezoelectric element / transducer, is initiated by the microcontroller using software by sending a PWM signal to the MOSFET or an I2C signal to a frequency generator chip. Stopping injection, or deactivating the piezoelectric element / transducer, is initiated by stopping the PWM signal to the MOSFET or sending another I2C signal to the frequency generator chip.

[0021] In an embodiment, a Bluetooth module 140 may be provided to allow communication with a smart device, such as a smart phone, so as to track dosage management and / or other data related to the user or the device via a Bluetooth-enabled application running on the smart device. Data received by the application may be transmitted to a network (e.g., via an Internet connection), including processing such data to provide resulting messages and information about the user's treatment, compliance, dosage, and use of the device to a healthcare provider or patient / personal monitoring service. An accelerometer 145 may also be operably connected to the MCU 100 to provide orientation and tilt information of the device, which may require changes to dosage calculations or trigger notifications to the user to adjust the positioning of the device to optimize the delivery of the drug administration.

[0022] Although piezoelectric electronic components, including specific types and brands of electronic components, are described in the embodiments of the present invention, it should be appreciated that other components can be used as transducers to provide vibration functions to the sprayer to generate aerosol. Similarly, although specific data communication protocols (I2C, SPI, etc.) are described or illustrated in certain embodiments of the present invention, those skilled in the relevant art will appreciate that various other data communication protocols can be applied and achieve the same effect.

[0023] Various embodiments of the present invention have been described above. However, it will be apparent that various modifications and variations may be made thereto, and further embodiments may be implemented, without departing from the broader scope of the invention as set forth in this disclosure. This description is to be regarded as illustrative rather than restrictive.

Claims

1. A droplet delivery device comprising: a vibrating ejector member coupled to a supply of the composition; and A dose monitor turns power to the vibrating ejector member on and off based on incomplete inhalation of a full dose of the composition by a user.

2. The device of claim 1 further comprising a pressure sensor in communication with a microcontroller of the device, wherein the microcontroller turns the vibrating ejector member on and off based on a user's inhalation pressure value relative to the device.

3. The device of claim 2, further comprising a speaker in communication with the microcontroller to provide an audible notification to a user of the remaining dose required to complete administration of a full dose of the composition.

4. The device of claim 3 further comprising a display or light in communication with the microcontroller to provide a user with visual notification of the remaining dose required to complete administration of a full dose of the composition.

5. The device of claim 2, further comprising a display or light in communication with the microcontroller to provide a user with visual notification of the remaining dose required to complete administration of a full dose of the composition.

6. The device of claim 1 further comprising a liquid supply cartridge having an identifier, said identifier communicating full dose parameters of said composition corresponding to said liquid supply cartridge to said dose monitor.

7. The device of claim 2, further comprising a liquid supply cartridge having an identifier, said identifier communicating full dose parameters of said composition corresponding to said liquid supply cartridge to said microcontroller.

8. The device of claim 3, further comprising a liquid supply cartridge having an identifier, said identifier communicating full dose parameters of said composition corresponding to said liquid supply cartridge to said microcontroller.

9. The device of claim 4, further comprising a liquid supply cartridge having an identifier, said identifier communicating full dose parameters of said composition corresponding to said liquid supply cartridge to said microcontroller.

10. The device of claim 5, further comprising a liquid supply cartridge having an identifier, said identifier communicating full dose parameters of said composition corresponding to said liquid supply cartridge to said microcontroller.

11. The device of claim 2, wherein the microcontroller is programmed to calculate drug efficacy by detecting a combination of instantaneous flow rate and amount of inhalation time from a pressure sensor during inhalation by a user, and to determine the remaining dose required to complete administration of a full dose of the composition.

12. The device of claim 3, wherein the microcontroller is programmed to calculate drug efficacy by detecting a combination of instantaneous flow rate and amount of inhalation time from a pressure sensor during inhalation by a user, and to determine the remaining dose required to complete administration of a full dose of the composition.

13. The device of claim 4, wherein the microcontroller is programmed to calculate drug efficacy by detecting a combination of instantaneous flow rate and amount of inhalation time from a pressure sensor during inhalation by a user and to determine the remaining dose required to complete administration of a full dose of the composition.

14. The device of claim 5, wherein the microcontroller is programmed to calculate drug efficacy by detecting a combination of instantaneous flow rate and amount of inhalation time from a pressure sensor during inhalation by a user, and to determine the remaining dose required to complete administration of a full dose of the composition.

15. The device of claim 7, wherein the microcontroller is programmed to calculate drug efficacy by detecting a combination of instantaneous flow rate and amount of inhalation time from a pressure sensor during inhalation by a user, and to determine the remaining dose required to complete administration of a full dose of the composition.

16. The device of claim 8, wherein the microcontroller is programmed to calculate drug efficacy by detecting a combination of instantaneous flow rate and amount of inhalation time from a pressure sensor during inhalation by a user and determine the remaining dose required to complete administration of a full dose of the composition.

17. The device of claim 9, further comprising a liquid supply cartridge having an identifier, said identifier communicating full dose parameters of said composition corresponding to said liquid supply cartridge to said microcontroller.

18. The device of claim 10, further comprising a liquid supply cartridge having an identifier, said identifier communicating full dose parameters of said composition corresponding to said liquid supply cartridge to said microcontroller.

19. A droplet delivery device comprising: a vibrating ejector member coupled to a supply of the composition; a transducer coupled to the vibrating ejector member; and A microcontroller turns power to the transducer on or off based on incomplete inhalation of a full dose of the composition by a user.

20. The device of claim 19, further comprising a pressure sensor in communication with the microcontroller, wherein the microcontroller automatically turns the transducer on and off based on a user's inhalation pressure value relative to the device.

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