Derivative works — US Patent 10814058

The following "Defensive Disclosure" document details derivative variations of US patent 10814058, aiming to establish prior art for potential future incremental improvements by competitors. This document focuses on Independent Claim 1 of US10814058.

Defensive Disclosure Document for US10814058: Nasal Aspiration and Wash Device

This document outlines various technical derivatives and potential combinations of the core inventive concepts disclosed in US patent 10814058, a "Nasal aspiration and wash device." The purpose of this disclosure is to expand the existing body of prior art, making incremental advancements in this domain more readily deemed obvious or non-novel to a person having ordinary skill in the art.

Independent Claim 1 Analysis (US10814058)

Independent Claim 1 describes a nasal aspiration and wash device comprising: a shell member; a pump with inhalation and exhaust ports; a suction part having a suction inlet and an exhaust outlet communicated respectively with the pump's inhalation and exhaust ports; and a spray part having a spray outlet, a liquid storage cavity, and an electrical atomizer. Crucially, the suction inlet and spray outlet are spaced apart, and the exhaust outlet is positioned under the suction inlet on the shell member's outer surface. [cite: US10814058B2]

The following derivatives expand upon these core elements and their functional relationships.

Derivative Variations

1. Material & Component Substitution: Piezoelectric Micro-Pump Integration

Enabling Description: The conventional pump (12) within the nasal aspiration and wash device (1) is replaced with a solid-state piezoelectric micro-pump system. This system incorporates a piezoelectric actuator bonded to a flexible diaphragm, which, upon excitation by an alternating current (AC) voltage (e.g., 50-200 kHz, 5-50 Vpp), generates rhythmic displacement, inducing fluidic oscillations within a pump chamber. Integrated one-way micro-valves (e.g., diffuser or nozzle/diffuser elements) rectify this oscillatory motion into a net directional flow for both aspiration and exhaust functions. For aspiration, the piezoelectric pump creates a negative pressure differential at the inhalation port (121), drawing external gas into the suction part (13) at controlled flow rates (e.g., 0.1 to 1.0 L/min) and pressures (up to -10 kPa). The exhaust outlet (1241) is similarly coupled to a piezoelectric pump or a reversible configuration. This substitution enhances durability, reduces operational noise significantly, and facilitates further miniaturization. The electrical atomizer (141) also utilizes a piezoelectric element for vibrating mesh atomization, controlled synchronously by the device's printed circuit board (16) and battery (15).

graph TD
    A[Battery 15] --> B(PCB 16);
    B --> C{Piezoelectric Micro-Pump Controller};
    C --> D[Piezoelectric Diaphragm - Aspiration];
    C --> E[Piezoelectric Diaphragm - Atomization];
    D --> F[Inhalation Port 121];
    E --> G[Atomization Unit 141];
    F --> H[Suction Part 13];
    G --> I[Spray Part 14];
    H --> J[Collection Cavity 132];
    I --> K[Liquid Storage Cavity 142];
    J --> L[Exhaust Outlet 1241];

2. Material & Component Substitution: Ultrasonic Nebulizer using Vibrating Mesh (VMN)

Enabling Description: The electrical atomizer (141) is specifically realized as a vibrating mesh nebulizer (VMN). This VMN incorporates a precisely fabricated mesh (e.g., an electroformed or laser-drilled nickel alloy membrane with apertures ranging from 2-5 micrometers in diameter) positioned at the interface between the liquid storage cavity (142) and the spray outlet (1411). A piezoelectric transducer is mechanically coupled to this mesh. When driven by a high-frequency alternating current (e.g., 100 kHz - 2 MHz) from the printed circuit board (16), the piezoelectric element causes the mesh to oscillate rapidly. This rapid oscillation forces the liquid (143) through the mesh pores, generating a fine aerosol with a consistent droplet size (typically 1-5 μm). The liquid storage cavity is designed with wicking structures to ensure continuous liquid supply to the mesh surface. This VMN design ensures silent operation, high atomization efficiency, and precise control over droplet size for optimized therapeutic delivery.

graph TD
    A[Liquid Storage Cavity 142] --> B{Liquid 143};
    B --> C[Vibrating Mesh];
    D[Piezoelectric Transducer] --> C;
    E[PCB 16] --> F{High-Frequency Driver};
    F --> D;
    C --> G[Atomized Liquid];
    G --> H[Spray Outlet 1411];

3. Operational Parameter Expansion: Thermally Conditioned Nasal Wash Device

Enabling Description: The nasal aspiration and wash device (1) is enhanced with an integrated liquid thermal conditioning unit. This unit includes a micro-resistive heating element or a Peltier thermoelectric module disposed within or adjacent to the liquid storage cavity (142). Controlled by the printed circuit board (16), this element warms the liquid (143) to a physiologically optimal temperature range, typically 30°C to 40°C, and maintains it within a narrow tolerance (e.g., ±1°C). A thermistor or Resistance Temperature Detector (RTD) sensor provides real-time temperature feedback to the PCB. An external indicator (e.g., a multi-color LED or small LCD) on the shell member (11) displays the current liquid temperature and confirms readiness for use. This thermal conditioning improves user comfort during nasal irrigation and can enhance the efficacy of mucociliary clearance and the delivery of temperature-sensitive medicinal solutions. The pump (12) and suction part (13) operate independently, unaffected by the thermal conditioning.

graph TD
    A[Battery 15] --> B(PCB 16);
    B --> C{Temperature Controller};
    C --> D[Heating Element];
    E[Thermistor Sensor] --> C;
    D -- heats --> F[Liquid Storage Cavity 142];
    F --> G[Atomization Unit 141];
    G --> H[Spray Outlet 1411];
    B --> I[Pump 12];
    I --> J[Suction Part 13];

4. Operational Parameter Expansion: Variable Pressure Aspiration with Flow Control

Enabling Description: The pump (12) is implemented as a variable-speed miniature diaphragm pump, and the suction part (13) is augmented with a MEMS-based differential pressure transducer located within the collection cavity (132) or the second inhalation tube (134). The printed circuit board (16) incorporates a closed-loop Proportional-Integral-Derivative (PID) control algorithm. This algorithm continuously monitors the negative pressure generated at the suction inlet (1331) via the pressure sensor and dynamically adjusts the pump's motor speed (e.g., via Pulse Width Modulation, PWM) to maintain a user-selected aspiration pressure. The device offers multiple preset aspiration pressure modes (e.g., gentle: -5 kPa, moderate: -15 kPa, strong: -30 kPa) accessible through the start button (17) or a dedicated control. Additionally, a micro-flow sensor (e.g., thermal mass flow sensor) can be integrated to prevent excessive flow rates that might cause tissue irritation or insufficient aspiration due to air leakage.

graph TD
    A[Start Button 17] --> B(PCB 16);
    C[Pressure Sensor] --> B;
    B --> D{Pump Speed Controller};
    D --> E[Variable Speed Pump 12];
    E --> F[Inhalation Port 121];
    F --> G[Suction Part 13];
    G --> H[Suction Inlet 1331];
    G --> I[Collection Cavity 132];
    I --> C;

5. Cross-Domain Application: Automated Plant Treatment and Pest Monitoring Device (AgTech)

Enabling Description: The fundamental architecture of the nasal aspiration and wash device (1) is adapted for automated agricultural applications. The shell member (11) is re-engineered for integration into an autonomous robotic platform or a specialized handheld sprayer for controlled environment agriculture (e.g., vertical farms). The spray part (14) delivers atomized pesticides, fungicides, or targeted nutrient solutions to plant foliage or specific zones. The electrical atomizer is optimized for generating fine mists (e.g., 20-50 µm droplet size) to ensure efficient coverage and minimize waste. The liquid storage cavity (142) is scaled for larger volumes of agricultural liquids. The suction part (13) is equipped with a specific suction inlet (1331) design (e.g., with passive filtration or electrostatic collection) to capture airborne pests (e.g., aphids, mites, fungal spores) or environmental particulate matter from plant surfaces or ambient air. The collection cavity (132) includes a removable, sealed analytical cartridge for subsequent microscopic examination or rapid molecular analysis of collected biological samples, facilitating early disease detection and targeted pest management. The independent operation of spray and suction prevents cross-contamination.

graph TD
    A[Robotic Platform/Handheld Shell] --> B(Control System PCB);
    B --> C[Spray Part (Nutrient/Pesticide)];
    C --> D[Atomization Unit];
    D --> E[Spray Outlet (Plant Target)];
    B --> F[Suction Part (Pest/Spore)];
    F --> G[Suction Inlet (Plant/Air)];
    G --> H[Collection Cavity (Analysis Cartridge)];

6. Cross-Domain Application: Precision Dusting and Cleaning System (Consumer Electronics)

Enabling Description: The nasal aspiration and wash device (1) is re-purposed as a precision cleaning and maintenance tool for sensitive electronic components. The suction part (13) provides a controlled, low-pressure, high-flow aspiration function to meticulously remove dust, lint, and micro-particulates from intricate circuit boards, delicate cooling fins, and sensitive electrical connectors without requiring physical contact. The suction inlet (1331) is modular, accepting various interchangeable, anti-static nozzle tips (e.g., fine brush, narrow crevice, wide fan). The spray part (14) delivers atomized, non-conductive cleaning solvents (e.g., high-purity isopropyl alcohol), specialized cooling agents (e.g., de-ionized water mist), or anti-static coatings. The liquid storage cavity (142) is designed for secure containment of these specialized liquids. The spaced-apart arrangement of the suction inlet (1331) and spray outlet (1411) is critical to prevent immediate re-deposition of aspirated dust or premature suction of applied cleaning agents. Both functions are independently activated via distinct control buttons (17, 18).

graph TD
    A[Shell Member (Ergonomic Handle)] --> B(Control PCB);
    B --> C[Suction Part (Dust Removal)];
    C --> D[Interchangeable Nozzles];
    D --> E[Suction Inlet (Component Target)];
    B --> F[Spray Part (Cleaning/Cooling Agent)];
F --> G[Atomization Unit];
G --> H[Spray Outlet (Component Target)];
I[Liquid Storage Cavity] --> F;
C --- F; % Indicate independent but co-located functions

7. Integration with Emerging Tech: Smart Nasal Care Device with AI-driven Biofeedback

Enabling Description: The nasal aspiration and wash device (1) is upgraded with AI-driven optimization capabilities. This involves integrating a suite of miniature biosensors, such as an optical turbidity sensor within the collection cavity (132) to assess mucus viscosity, a localized moisture sensor at the spray outlet (1411) to evaluate nasal cavity hydration, and a miniature gas sensor for ambient air quality. Data from these sensors is fed into an embedded microcontroller on the printed circuit board (16), which executes a pre-trained, lightweight AI model (e.g., a recurrent neural network or decision tree). This AI model dynamically adjusts the pump (12) suction power (e.g., by modulating motor Pulse Width Modulation, PWM) and the atomization unit (141) output (e.g., by altering vibration frequency or amplitude). For example, if high-viscosity mucus is detected, the AI increases suction pressure; if the nasal cavity is deemed insufficiently hydrated after a spray, the atomization intensity is boosted. User profiles and historical usage data are stored locally or synced to a cloud platform to continuously refine the AI's adaptive algorithms, providing personalized and optimized nasal care.

graph TD
    A[Start/Atomization Buttons] --> B(Input Interface);
    C[Optical Turbidity Sensor] --> D(Sensor Data Module);
    E[Moisture Sensor] --> D;
    F[Air Quality Sensor] --> D;
    D --> G{Embedded Microcontroller with AI Model};
    G --> H[Pump 12 Controller];
    G --> I[Atomization Unit 141 Controller];
    H --> J[Suction Part 13];
    I --> K[Spray Part 14];
    G -- Personalization --> L[User Profile Database];

8. Integration with Emerging Tech: Connected Nasal Health Monitor with IoT Sensors

Enabling Description: The device (1) is transformed into a connected nasal health monitor through the integration of multiple IoT sensors and a wireless communication module (e.g., Bluetooth Low Energy (BLE) or Wi-Fi, compliant with IEEE 802.11 b/g/n) on the printed circuit board (16). The integrated sensors include:
1. A capacitive or optical liquid level sensor in the liquid storage cavity (142).
2. A precise battery charge level indicator for battery (15).
3. A digital usage counter (tracking activations of aspiration and spray functions).
4. A pressure sensor in the suction pathway (as described in Derivative 4).
5. An ambient temperature and humidity sensor.
  All sensor data is periodically transmitted via the wireless module to a connected smartphone application or a secure, cloud-based health platform. This enables real-time monitoring of the device's operational status, tracking of personal nasal hygiene patterns, automated reminders for liquid refills or cleaning, and remote diagnostics. Data can be anonymized and aggregated for public health trend analysis.

graph TD
    A[Nasal Device 1] --> B(PCB 16);
    B --> C[Wireless Module (BLE/Wi-Fi)];
    D[Liquid Level Sensor] --> B;
    E[Battery Sensor] --> B;
    F[Usage Counter] --> B;
    G[Pressure Sensor] --> B;
    H[Ambient Temp/Humidity Sensor] --> B;
    C --> I(Smartphone App/Cloud Platform);
    I -- Data Aggregation --> J(Health Insights Database);

9. The "Inverse" or Failure Mode: Intelligent Obstruction Detection and Safe Shutdown

Enabling Description: The suction part (13) of the device is augmented with an intelligent safety mechanism for obstruction detection. This involves a micro-differential pressure sensor, strategically placed to measure pressure variations across the suction path, and a miniature flow sensor (e.g., a hot-wire anemometer or ultrasonic flow sensor) embedded in the second inhalation tube (134). The printed circuit board (16) continuously monitors the data from these sensors. If the control algorithm detects a sudden and significant decrease in flow rate concurrently with a sharp increase in negative pressure at the suction inlet (1331)—indicative of an obstruction such as complete occlusion by nasal tissue or dense mucus—exceeding a predefined safety threshold (e.g., pressure > -50 kPa for longer than 1 second), the pump (12) automatically initiates a safe shutdown. This immediate cessation of aspiration prevents potential tissue damage or pump motor overload. A visual (e.g., flashing LED) and/or auditory alarm alerts the user to clear the obstruction. The system logs these events, including duration and pressure peaks, for diagnostic and safety analysis.

graph TD
    A[Suction Part 13] --> B[Differential Pressure Sensor];
    A --> C[Flow Sensor];
    B --> D(PCB 16);
    C --> D;
    D --> E{Obstruction Detection Algorithm};
    E -- Threshold Exceeded --> F[Pump 12 Controller];
    F --> G[Pump 12];
    G -- Power Off --> H[Safe Shutdown];
    E -- Alert --> I[LED/Auditory Alarm];
    E -- Log --> J[Event Log];

10. The "Inverse" or Failure Mode: Eco-Mode for Extended Operation and Gentle Use

Enabling Description: The device (1) features an "Eco-Mode" for extended battery life and gentler operation, activatable via a dedicated button or a specific press sequence on the start button (17). In this mode, the printed circuit board (16) adjusts the operational parameters of both the pump and the atomizer. For the spray part (14), the electrical atomizer (141) operates at a reduced power setting, resulting in a lower atomization rate or a slightly coarser droplet size (e.g., 8-12 μm), thereby extending the usable volume from the liquid storage cavity (142) and conserving battery (15) energy. For the suction part (13), the pump (12) operates at a lower rotational speed, generating a milder negative pressure (e.g., -5 kPa to -10 kPa), making it suitable for sensitive users, infants, or for general, less intensive aspiration. The device's battery status LED provides visual feedback, indicating the active mode (e.g., a distinct color or blinking pattern for Eco-Mode). The PCB manages adaptive power profiles to ensure optimal energy efficiency while maintaining core functionality.

graph TD
    A[Start Button 17] --> B(PCB 16);
    B --> C{Mode Selection Logic};
    C -- Eco-Mode Activated --> D[Pump 12 Controller (Low Power)];
    C -- Eco-Mode Activated --> E[Atomizer 141 Controller (Low Power)];
    D --> F[Pump 12];
    E --> G[Atomization Unit 141];
    F --> H[Suction Part 13 (Gentle)];
    G --> I[Spray Part 14 (Reduced Output)];
    C -- Status Update --> J[Battery Status LED];

Combination Prior Art Scenarios

These scenarios combine aspects of US10814058 with existing open-source standards, further solidifying prior art and rendering future claims obvious.

US10814058 + Bluetooth Low Energy (BLE) (IEEE 802.15.1 Standard):
- Description: A nasal aspiration and wash device (US10814058) integrating a Bluetooth Low Energy (BLE) module (compliant with the IEEE 802.15.1 standard) on its printed circuit board (16). This module enables wireless communication with external user devices such as smartphones, tablets, or wearable health trackers. The device is configured to transmit usage data (e.g., duration of aspiration, number of spray cycles, remaining liquid levels, battery status) to a companion mobile application. This application, developed using open-source BLE profiles (e.g., Health Device Profile (HDP) or custom Generic Attribute Profile (GATT) services), provides a user interface for tracking nasal hygiene routines, scheduling reminders, and potentially allowing remote activation of non-critical device functions (e.g., initiating a pre-warm cycle for the spray liquid, as described in Derivative 3). This combination renders the "smart" or connected functionality of such medical devices obvious by leveraging a widely adopted, low-power wireless communication standard.
US10814058 + MQTT (Message Queuing Telemetry Transport) Protocol:
- Description: An advanced iteration of the nasal aspiration and wash device (US10814058) designed for centralized monitoring and management in clinical, institutional, or multi-user home environments. The device incorporates a Wi-Fi or cellular module (for internet connectivity) and communicates using the MQTT protocol. Embedded sensors (e.g., liquid level in cavity 142, battery charge of 15, pump run-time, atomizer activation count) gather telemetry data. This data is published as lightweight MQTT messages to a central MQTT broker, which could be hosted on a local network or a cloud platform. A designated IT system or healthcare management application subscribes to these MQTT topics to monitor device readiness across a fleet, manage inventory of medicinal liquids, track cumulative device utilization, and predict maintenance requirements. The MQTT protocol (an OASIS and ISO standard, widely deployed in IoT and open-source projects) provides an efficient and scalable messaging paradigm, thereby making the remote, networked monitoring of medical devices obvious.
US10814058 + DICOM (Digital Imaging and Communications in Medicine) / HL7 (Health Level Seven International) Standards for Data Export:
- Description: A diagnostic-enabled variant of the nasal aspiration and wash device (US10814058, incorporating advanced sensor capabilities such as those described in Derivative 7). This device collects not only basic usage metrics but also specific biofeedback data, such as optical turbidity readings of aspirated mucus (indicative of inflammation or infection), or even micro-analytical data from captured samples within the collection cavity (132). To ensure seamless interoperability and integration with existing healthcare information systems, the device's embedded software is capable of formatting and exporting this diagnostic and usage data according to established medical standards. Specifically, it can generate data compliant with DICOM (for any image-based analyses or structured reports) or HL7 (for general structured health information, including usage logs, sensor readings, and AI-derived insights). This integration allows the device to function as a data-generating endpoint within a broader healthcare ecosystem, making the standardized exchange of medical device data obvious. For example, a "Nasal Health Activity Report" could be generated, conforming to the HL7 Clinical Document Architecture (CDA).