Derivative works

Defensive Disclosure Document for US Patent 12089889

Current Date: April 26, 2026

This Defensive Disclosure document outlines derivative variations of the technology described in US Patent 12089889, "Systems and methods for therapeutic nasal treatment using handheld device." The intent is to establish prior art, rendering future incremental advancements or obvious modifications by competitors non-novel or obvious, thereby limiting the scope of potential future patent claims. This disclosure is structured around the independent claims of US12089889.

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Derivatives for Independent Claim 1: Handheld Device

Claim 1 Summary (Internal Reference Only): A handheld device for treating a condition within a nasal cavity, comprising an elongate body, a handle, and a multi-segment end effector. The end effector is retractable and expandable, with at least first and second flexible segments that conform to anatomical structures and position electrodes for energy delivery. The elongate body also includes electrodes for energy delivery to tissue. The handle has separate mechanisms for end effector deployment and energy control for one-handed operation. Markings on the device provide spatial orientation.

Derivative 1.1: Material & Component Substitution - Shape Memory Polymer End Effector with Piezoelectric Elements

Enabling Description: The multi-segment end effector is constructed from a shape memory polymer (SMP) matrix, such as a polyurethane-based SMP or a semicrystalline polymer like poly(ε-caprolactone) (PCL), which transitions from a rigid, retracted state to a pre-programmed expanded shape upon localized thermal activation (e.g., resistive heating wires embedded within the SMP or external warm saline irrigation). Instead of conventional RF electrodes, each segment of the end effector integrates an array of lead zirconate titanate (PZT) piezoelectric ceramic elements. These PZT elements are configured to deliver targeted, high-frequency ultrasonic energy for localized mechanical cell disruption (cavitation) or low-frequency mechanical vibration for neural modulation, rather than thermal energy. The elongate body, similarly, can integrate flexible piezoelectric film transducers (e.g., PVDF) along its length for broader, lower-power ultrasonic neuromodulation or for localized fluid agitation to clear mucus. The handle's energy control mechanism modulates the frequency, amplitude, and pulse duration of the piezoelectric output.

classDiagram
    class HandheldDevice {
        +ElongateBody elongateBody
        +Handle handle
        +SMPEndEffector endEffector
    }
    class SMPEndEffector {
        +FlexibleSegment firstSegment
        +FlexibleSegment secondSegment
        +PiezoelectricElement[*] piezoElements
        +SMPMatrix smpMaterial
        +ThermalActivationUnit heater
        +retract()
        +expand(thermalInput)
        +deliverUltrasonicEnergy()
    }
    class FlexibleSegment {
        +SMPMatrix smpMaterial
        +PiezoelectricElement[*] piezoElements
    }
    class PiezoelectricElement {
        +PZTMaterial material
        +deliverUltrasonicEnergy(frequency, amplitude)
    }
    class ElongateBody {
        +PVDFTransducer[*] pvdfTransducers
        +deliverLowPowerUltrasonic()
    }
    class Handle {
        +DeploymentMechanism deployMechanism
        +EnergyControlMechanism energyControl
    }
    HandheldDevice --> ElongateBody
    HandheldDevice --> Handle
    ElongateBody --o SMPEndEffector : retracts/expands
    SMPEndEffector *-- FlexibleSegment
    FlexibleSegment *-- PiezoelectricElement
    ElongateBody *-- PVDFTransducer
    Handle --> DeploymentMechanism
    Handle --> EnergyControlMechanism

Derivative 1.2: Operational Parameter Expansion - Nanoscale Micro-Electrode Arrays with Tunable Pulsed Electric Fields

Enabling Description: The device is miniaturized to operate at a nanoscale, with the multi-segment end effector featuring MEMS-fabricated flexible segments, approximately 100-500 micrometers in thickness. These segments deploy micro-electrode arrays, each electrode having a tip diameter of 1-10 micrometers, fabricated using platinum-iridium thin films on a polymer substrate. The elongate body also integrates similar micro-electrode arrays. The energy delivered is in the form of tunable pulsed electric fields (PEF) for non-thermal electroporation (reversible or irreversible) of neural membranes, operating at frequencies from 1 kHz to 1 MHz, pulse durations from nanoseconds to microseconds, and field strengths from 100 V/cm to 10 kV/cm. This allows for highly localized, intracellular-level neuromodulation without significant bulk tissue heating. The device includes a microfluidic channel for delivering localized buffers to control tissue conductivity.

flowchart TD
    A[Handheld Device] --> B{Nanoscale End Effector}
    B --> C[MEMS Flexible Segments]
    C --> D[Micro-Electrode Arrays (1-10 µm tips)]
    B --> E[Elongate Body Micro-Electrode Arrays]
    F[Console/Generator] --> G{Tunable Pulsed Electric Field (PEF) Generation}
    G --> D
    G --> E
    D -- (1kHz-1MHz, ns-µs pulses) --> H[Localized Electroporation]
    E -- (100V/cm-10kV/cm) --> I[Neural Membrane Modulation]
    B --> J[Microfluidic Channel for Buffer Delivery]

Derivative 1.3: Cross-Domain Application - Precision Micro-Solder Reflow Tool for Circuit Boards

Enabling Description: This handheld device is adapted as a precision micro-solder reflow tool for intricate circuit board repair or component attachment. The elongate body is a thermally conductive ceramic probe. The multi-segment end effector, also ceramic or high-temperature polymer, expands to precisely contact specific solder pads or component leads. Instead of therapeutic energy, the electrodes deliver highly focused, controlled thermal energy (e.g., resistive heating to 250-350°C, or localized inductive heating) to reflow solder without damaging adjacent components. The handle's deployment mechanism precisely controls the pressure and contact area of the end effector, while the energy control modulates the reflow temperature and duration. Markings on the device indicate spatial orientation relative to target components.

classDiagram
    class MicroSolderTool {
        +CeramicProbe ceramicProbe
        +ErgonomicHandle handle
        +ExpandableReflowHead reflowHead
    }
    class ExpandableReflowHead {
        +CeramicSegments segments
        +InductiveHeatingCoils heatingCoils
        +TemperatureSensors sensors
        +expand()
        +retract()
        +applyControlledHeat(temp, duration)
    }
    class CeramicSegments {
        +Material ceramicPolymer
    }
    class ErgonomicHandle {
        +DeploymentControl deployControl
        +ThermalControl thermalControl
    }
    MicroSolderTool --> CeramicProbe
    MicroSolderTool --> ErgonomicHandle
    CeramicProbe --o ExpandableReflowHead : extends/retracts
    ExpandableReflowHead *-- CeramicSegments
    ExpandableReflowHead *-- InductiveHeatingCoils
    ExpandableReflowHead *-- TemperatureSensors
    ErgonomicHandle --> DeploymentControl
    ErgonomicHandle --> ThermalControl

Derivative 1.4: Integration with Emerging Tech - AI-Optimized Nasal Treatment Device with IoT Monitoring

Enabling Description: The handheld device incorporates an array of IoT sensors (e.g., miniature accelerometers, gyroscopes, temperature, impedance, oxygen saturation sensors) within the end effector and along the elongate body. These sensors transmit real-time anatomical and physiological data wirelessly (e.g., via Wi-Fi or Bluetooth LE) to a console with an integrated AI module. The AI-driven optimization system processes this data to: (1) autonomously guide the deployment and positioning of the end effector segments to the optimal target sites based on a pre-loaded patient 3D anatomical model and intra-operative sensor feedback; (2) predict optimal energy delivery parameters (e.g., RF power, pulse duration, temperature profile) for therapeutic modulation, continuously adjusting in real-time to maximize efficacy and minimize collateral damage; and (3) provide haptic or visual feedback to the operator for manual adjustments if necessary. The system maintains a blockchain-verified immutable ledger of device usage, treatment parameters, sensor readings, and AI decisions for auditing and regulatory compliance.

sequenceDiagram
    participant H as Handheld Device (IoT Sensors)
    participant C as Console (AI Module)
    participant B as Blockchain Ledger
    participant O as Operator (Haptic/Visual Feedback)

    H->>C: Transmit Real-time Sensor Data (Temp, Imp, O2Sat, Pos)
    C->>C: AI processes data & patient 3D model
    C->>C: AI determines optimal EE position & energy params
    C->>H: Send Deployment & Energy Control Commands
    H->>O: Provide Haptic/Visual Feedback (for manual adj.)
    H->>H: Adjust EE deployment & Energy delivery
    H->>C: Confirm actions/new sensor data
    C->>B: Record Immutable Treatment Log (Params, Sensor Data, AI Decisions)
    O->>B: Verify/Sign-off on Treatment Log

Derivative 1.5: The "Inverse" or Failure Mode - Diagnostic-Only Handheld with Safe Retraction Mechanism

Enabling Description: This derivative functions primarily as a diagnostic tool, with all therapeutic energy delivery capabilities (e.g., RF generator connection) removed or permanently deactivated. The electrodes on the end effector and elongate body are re-purposed as highly sensitive bio-impedance sensors and temperature probes, used for detailed mapping of tissue characteristics and nerve pathways without any therapeutic intent. In the event of a detected critical error (e.g., excessive tissue contact force, device malfunction, loss of communication with the console), the end effector's deployment mechanism automatically and rapidly engages a spring-loaded, passive retraction system, drawing the flexible segments into the elongate body. This retraction is designed to be gentle and atraumatic, ensuring safe removal from the nasal cavity without causing injury, operating on an independent, non-powered mechanical failsafe or minimal stored energy. The device includes a clear visual indicator (e.g., an LED) that changes color to confirm diagnostic-only mode and safe-state status.

stateDiagram-v2
    [*] --> Initialized: Device Power On
    Initialized --> DiagnosticMode: Energy Delivery Deactivated
    DiagnosticMode --> Sensing: Activate Bio-impedance & Temp Sensors
    Sensing --> DataAcquisition: Collect & Transmit Data
    DataAcquisition --> DiagnosticMode: Continuous Monitoring

    Sensing --> ErrorDetected: Force > Threshold OR Malfunction
    DataAcquisition --> ErrorDetected: Malfunction OR Comm. Loss
    ErrorDetected --> SafeRetraction: Activate Spring-Loaded Retraction
    SafeRetraction --> RetractedSafe: End Effector Fully Retracted
    RetractedSafe --> [*]: Device Safe & Ready for Removal

    DiagnosticMode --> VisualConfirmation: LED Indicator (Green for Safe)
    ErrorDetected --> VisualConfirmation: LED Indicator (Red for Error)

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Derivatives for Independent Claim 11: Method for Improving Sleep

Claim 11 Summary (Internal Reference Only): A method for improving a patient's sleep by treating at least one of rhinitis, congestion, and rhinorrhea within a sino-nasal cavity of the patient, comprising delivering energy to one or more target sites to disrupt neural signals and/or result in local hypoxia, thereby reducing mucus production and/or mucosal engorgement, and improving nasal breathability. The energy delivery causes thermal ablation of targeted tissue.

Derivative 11.1: Material & Component Substitution (Method) - Targeted Drug Delivery via Micro-Needle Arrays

Enabling Description: The method involves delivering a targeted pharmacological agent to disrupt neural signals and/or reduce mucosal engorgement, replacing thermal ablation. Instead of an energy delivery element, the end effector segments and elongate body are equipped with arrays of hollow, dissolvable micro-needles (e.g., composed of hyaluronic acid or polylactic-co-glycolic acid). These micro-needles contain and deliver highly localized doses of a neuromodulatory agent (e.g., a long-acting acetylcholine receptor antagonist like ipratropium bromide, a vasoactive intestinal peptide antagonist, or a localized vasoconstrictor like oxymetazoline) directly to the postganglionic parasympathetic nerve fibers or submucosal glands in the target sites (e.g., sphenopalatine foramen region, inferior turbinate). The dissolution of the micro-needles ensures precise, sustained release without systemic side effects. The "energy delivery" step is reinterpreted as the mechanical insertion and subsequent dissolution of the drug-loaded micro-needles, disrupting neural function through chemical means.

flowchart TD
    A[Identify Target Sites (Rhinitis, Congestion)] --> B{Advance Device to Sino-Nasal Cavity}
    B --> C[Deploy End Effector Segments]
    C --> D[Micro-Needle Arrays Contact Tissue]
    D --> E[Deliver Neuromodulatory Agent (e.g., Ipratropium Bromide)]
    E --> F{Dissolvable Micro-Needles Release Agent}
    F --> G[Localized Neural Signal Disruption / Vasoconstriction]
    G --> H[Reduce Mucus Production / Mucosal Engorgement]
    H --> I[Improve Nasal Breathability]
    I --> J[Improve Patient Sleep]

Derivative 11.2: Operational Parameter Expansion (Method) - Cryo-Neuromodulation with Ultra-Low Temperatures

Enabling Description: The method utilizes cryo-neuromodulation instead of thermal ablation. Energy delivery involves highly focused application of cryogenic temperatures (e.g., -80°C to -196°C) to the target sites. The end effector and elongate body incorporate miniature cryo-probes that circulate a supercooled fluid (e.g., liquid nitrogen, supercooled ethanol vapor) or utilize Peltier effect cooling elements. The controlled ultra-low temperature induces reversible cryo-blockade of nerve conduction or, with sustained exposure, irreversible cryo-ablation of the targeted postganglionic parasympathetic fibers and mucosal engorgement elements. The process monitors tissue temperature in real-time to precisely control the depth and extent of cooling, balancing between temporary neuromodulation and permanent ablation to achieve desired symptom relief while preserving tissue integrity.

stateDiagram-v2
    state "Initial State" as Init
    state "Target Site Identification" as Target
    state "Device Positioning" as Position
    state "Cryo-Probe Deployment" as Deploy
    state "Temperature Control" as TempControl
    state "Cryo-Neuromodulation" as CryoMod
    state "Neural Signal Disruption" as Disrupt
    state "Mucosal Effect Reduction" as ReduceEffect
    state "Improved Breathability" as Breathe
    state "Improved Sleep" as Sleep
    state "Re-warming / Recovery" as Recover

    Init --> Target
    Target --> Position
    Position --> Deploy
    Deploy --> TempControl : Circulate Cryo-Fluid / Activate Peltier
    TempControl --> CryoMod : Maintain -80°C to -196°C
    CryoMod --> Disrupt : Reversible Block or Irreversible Ablation
    Disrupt --> ReduceEffect
    ReduceEffect --> Breathe
    Breathe --> Sleep
    CryoMod --> TempControl : Monitor Tissue Temp
    CryoMod --> Recover : After Treatment
    Recover --> [*]

Derivative 11.3: Cross-Domain Application (Method) - Targeted Pest Control in Hydroponic Systems

Enabling Description: This method applies the concept of targeted energy delivery to disrupt biological function in hydroponic agricultural systems for pest control. The "sino-nasal cavity" is analogous to the root zone or nutrient reservoir of a hydroponic system. The "target sites" are specific locations where pests (e.g., fungus gnats, root aphids, nematodes) or pathogens (e.g., root rot fungi) are identified. The method involves advancing a specialized probe (analogous to the elongate body and end effector) into the hydroponic medium or nutrient solution. The probe delivers highly localized, pulsed electromagnetic energy (e.g., specific frequencies of UV-C light, pulsed electric fields, or low-power microwave radiation) to disrupt the life cycle of pests or the cell walls of pathogens, resulting in their demise or inactivation, thereby preventing root damage or nutrient uptake interference. This reduces plant stress, analogous to improving "nasal breathability," and optimizes crop growth, analogous to "improving sleep."

flowchart TD
    A[Identify Pest/Pathogen Infestation in Hydroponic System] --> B{Advance Specialized Probe into Root Zone/Reservoir}
    B --> C[Deploy Multi-Segment End Effector (Micro-Emitters)]
    C --> D[Deliver Localized Electromagnetic Energy (UV-C, PEF, Microwave)]
    D --> E{Disrupt Pest Life Cycle / Pathogen Cell Walls}
    E --> F[Eliminate Pests / Inactivate Pathogens]
    F --> G[Reduce Plant Stress / Optimize Nutrient Uptake]
    G --> H[Improve Crop Growth & Yield]

Derivative 11.4: Integration with Emerging Tech (Method) - AI-Guided Multi-Omics Based Neuromodulation

Enabling Description: This method integrates AI with multi-omics data for personalized neuromodulation. Prior to treatment, a patient undergoes comprehensive multi-omics profiling (genomics, proteomics, metabolomics, lipidomics) to identify individual biomarkers correlated with rhinitis, congestion, and rhinorrhea severity and specific neural pathway activity. This data, combined with real-time intra-operative impedance and temperature feedback, is fed into an AI model. The AI determines optimal, patient-specific energy delivery parameters (e.g., RF waveform, power, pulse duration, cooling cycles) and electrode activation sequences to achieve precise disruption of neural signals and/or hypoxia. Post-procedure, IoT sensors in a wearable nasal patch (for continuous nasal airflow and sleep quality monitoring) and periodic multi-omics re-profiling provide feedback to the AI model, which refines future treatment recommendations. This ensures highly personalized and adaptive therapeutic outcomes, minimizing adverse effects and maximizing long-term symptom relief.

graph TD
    A[Patient Multi-Omics Profiling (Genomics, Proteomics)] --> B{AI Model}
    C[Patient 3D Anatomy (MRI/CT)] --> B
    D[Real-time Intra-Op Data (Impedance, Temp)] --> B
    B --> E[Determine Optimal Energy Parameters & Electrode Sequence]
    E --> F[Deliver Personalized Energy to Target Sites]
    F --> G[Disrupt Neural Signals / Induce Local Hypoxia]
    G --> H[Reduce Symptoms]
    H --> I[Improve Sleep]
    I --> J[Post-Op IoT Sensor Data (Wearable)] --> B
    I --> K[Post-Op Multi-Omics Re-Profiling] --> B
    B --> L[Refine Treatment Recommendations]

Derivative 11.5: The "Inverse" or Failure Mode (Method) - Reversible Neuro-Inhibition for Diagnostic Mapping

Enabling Description: This method focuses on reversible neuro-inhibition for diagnostic purposes. Instead of permanent thermal ablation, the device delivers highly localized, low-frequency electrical stimulation (e.g., 1-10 Hz, sub-threshold current) or focused magnetic pulses (transient magnetic stimulation) to temporarily inhibit nerve conduction or induce a transient nerve block. This "energy delivery" causes a temporary, reversible disruption of neural signals without tissue damage or hypoxia. By selectively inhibiting different nerve branches and monitoring the patient's subjective symptoms or objective physiological responses (e.g., nasal airflow, mucus production rate), clinicians can precisely map the specific neural pathways contributing to the patient's rhinitis/congestion symptoms. This diagnostic approach allows for confirmation of target nerve involvement before proceeding with potentially irreversible therapeutic modulation, improving patient safety and efficacy of subsequent treatments. The "improved sleep" aspect here is a secondary effect of successful diagnostic mapping leading to more effective, targeted, and safe definitive treatments.

sequenceDiagram
    participant P as Patient
    participant D as Diagnostic Device (End Effector)
    participant C as Console (Monitoring)
    participant CL as Clinician

    CL->>P: Identify Symptoms (Rhinitis, Congestion)
    CL->>D: Position End Effector at suspected Target Site
    D->>C: Transmit Baseline Physiological Data
    C->>D: Deliver Low-Frequency Electrical / Magnetic Pulses
    D->>P: Induce Reversible Neuro-Inhibition
    P->>C: Report Symptom Changes / Objective Data (airflow, mucus)
    C->>CL: Display Neural Pathway Mapping & Response
    CL->>D: Reposition Device / Adjust Parameters (if needed)
    Note over C,CL: Repeat to map relevant neural pathways
    C->>P: Neuro-Inhibition Wears Off (Reversible)
    CL->>P: Plan Definitive Treatment based on map

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Derivatives for Independent Claim 19: System for Therapeutic Nasal Treatment

Claim 19 Summary (Internal Reference Only): A system for therapeutic nasal treatment, including a console, an energy generator, and a handheld neuromodulation device (elongate body, handle, multi-segment end effector). Both the end effector and elongate body have electrodes. The system is configured for the energy generator to deliver energy to both sets of electrodes simultaneously to multiple, distinct target sites.

Derivative 19.1: Material & Component Substitution (System) - Hybrid Opto-RF Energy System with Biodegradable Device

Enabling Description: The system's energy generator is a hybrid unit capable of delivering both radiofrequency (RF) energy and pulsed laser energy (e.g., from a solid-state fiber laser) simultaneously. The handheld neuromodulation device features an elongate body and multi-segment end effector constructed from biocompatible, biodegradable polymers (e.g., polyglycolic acid, polylactic acid) that safely resorb over time post-procedure, eliminating the need for device removal or long-term foreign body presence. The end effector's "electrodes" are re-designed as integrated RF electrode patches (e.g., platinum film) AND optical fibers with miniature diffusers or lenses for precise laser energy delivery (e.g., 1470 nm diode laser for interstitial heating, or 532 nm KTP laser for selective vascular photocoagulation). The elongate body similarly integrates RF electrodes and optical fibers. The console's control system allows for dynamic adjustment and simultaneous application of RF (e.g., 460 kHz, 10-50W) and laser energy (e.g., 5-20W) to distinct target sites, offering multi-modal therapeutic modulation (thermal ablation via RF, photo-coagulation via laser, or combined effects) for enhanced tissue specificity and reduced collateral damage.

classDiagram
    class OptoRFEnergySystem {
        +HybridEnergyGenerator hybridGenerator
        +BiodegradableHandheldDevice handheldDevice
        +ControlConsole console
    }
    class HybridEnergyGenerator {
        +RFModule rfGenerator
        +LaserModule laserSource
        +deliverRF(power, freq)
        +deliverLaser(wavelength, power, pulse)
    }
    class BiodegradableHandheldDevice {
        +BiodegradableElongateBody elongateBody
        +BiodegradableHandle handle
        +BiodegradableEndEffector endEffector
    }
    class BiodegradableEndEffector {
        +RFElectrode[*] rfPatches
        +OpticalFiber[*] opticalFibers
    }
    class BiodegradableElongateBody {
        +RFElectrode[*] rfPatches
        +OpticalFiber[*] opticalFibers
    }
    OptoRFEnergySystem --> HybridEnergyGenerator
    OptoRFEnergySystem --> BiodegradableHandheldDevice
    OptoRFEnergySystem --> ControlConsole
    BiodegradableHandheldDevice --o BiodegradableEndEffector
    BiodegradableHandheldDevice --o BiodegradableElongateBody
    BiodegradableEndEffector *-- RFElectrode
    BiodegradableEndEffector *-- OpticalFiber
    BiodegradableElongateBody *-- RFElectrode
    BiodegradableElongateBody *-- OpticalFiber
    HybridEnergyGenerator --> BiodegradableHandheldDevice : delivers energy

Derivative 19.2: Operational Parameter Expansion (System) - Sub-Hertz Low-Frequency Pulsed Electrical Field System

Enabling Description: This system focuses on non-ablative neuromodulation using ultra-low frequency (sub-Hertz) pulsed electrical fields (PEF). The energy generator delivers biphasic or monophasic electrical pulses at frequencies ranging from 0.1 Hz to 50 Hz, with pulse durations of 10-100 milliseconds and amplitudes up to 50V. This low-frequency stimulation aims to modulate neural activity through depolarization block or fatigue without causing thermal damage or ablation, rather than the higher-frequency RF typical for ablation. The electrodes on both the multi-segment end effector and the elongate body are specifically designed for low-impedance contact over larger surface areas to safely deliver these lower frequency, longer duration pulses. The system is configured for prolonged treatment sessions (e.g., 10-30 minutes) to achieve cumulative neuromodulatory effects, unlike rapid ablative procedures. The console provides precise control over frequency, pulse width, and amplitude, and includes biofeedback (e.g., ENG signals, impedance) to monitor neural response.

graph LR
    A[Console] --> B(Sub-Hertz PEF Generator)
    B --> C(Handheld Neuromodulation Device)
    C --> D[Multi-Segment End Effector (Large Surface Electrodes)]
    C --> E[Elongate Body (Large Surface Electrodes)]
    D -- (0.1Hz-50Hz, 10-100ms, <50V) --> F{Non-Ablative Neural Modulation}
    E -- (Monophasic/Biphasic) --> G{Targeted Neural Inhibition/Stimulation}
    F --> H[Reduced Mucus/Engorgement]
    G --> H
    H --> I[Improved Sleep]
    C --> J[Biofeedback Sensors (ENG, Impedance)]
    J --> B
    B -- Controls --> C

Derivative 19.3: Cross-Domain Application (System) - Precision Soil Remediation System for Contaminated Sites

Enabling Description: The system is repurposed for precision soil remediation in contaminated agricultural or industrial sites. The "console" becomes a mobile command unit, and the "energy generator" is a high-power, multi-frequency electromagnetic (EM) generator. The "handheld neuromodulation device" is a ruggedized, remotely operated probe designed for insertion into soil. The "elongate body" acts as a delivery shaft, and the "multi-segment end effector" deploys as a ground-contacting array. Both the end effector and elongate body incorporate robust electrodes designed to deliver various forms of EM energy (e.g., resistive heating for thermal desorption of organic pollutants, high-frequency pulsed EM for electrokinetic soil flushing, or microwave energy for soil sterilization). The system delivers energy simultaneously to distinct contaminated zones, promoting breakdown, immobilization, or extraction of pollutants. This targeted energy application minimizes disturbance to surrounding healthy soil, analogous to minimizing collateral damage in nasal tissue, and improves soil health, akin to improving a patient's breathing and sleep.

flowchart TD
    A[Mobile Command Unit] --> B{High-Power Multi-Frequency EM Generator}
    B --> C[Remotely Operated Soil Probe]
    C --> D[Ruggedized Elongate Body]
    C --> E[Multi-Segment End Effector (Soil-Contacting Electrode Array)]
    D -- Delivers EM Energy --> F{Targeted Pollutant Remediation}
    E -- Delivers EM Energy --> F
    F --> G[Breakdown / Immobilization / Extraction of Pollutants]
    G --> H[Improved Soil Health / Crop Yield]
    C --> I[Integrated Soil Sensors (Moisture, Temp, Conductivity)]
    I --> B

Derivative 19.4: Integration with Emerging Tech (System) - AR-Guided Robotic Neuromodulation System with DLT Authentication

Enabling Description: This system combines AI-driven robotic assistance, Augmented Reality (AR) guidance, and Distributed Ledger Technology (DLT) for enhanced precision and accountability. The handheld device is mounted on a robotic arm controlled by an AI navigation module integrated into the console. The console's energy generator delivers RF energy to electrodes on the device. Surgeons wear AR glasses that project patient-specific 3D anatomical models (from pre-operative CT/MRI) and real-time intra-operative data (e.g., electrode contact pressure, predicted thermal lesion geometry, nerve pathway visualization) directly onto the patient's nasal region. The AI autonomously refines the robotic arm's movements and energy delivery parameters based on this AR feedback and real-time impedance/temperature data. Furthermore, all device serial numbers, consumable component IDs (e.g., end effector cartridges), calibration data, and treatment logs (including AI decisions and surgeon sign-offs) are immutably recorded on a private blockchain. This DLT ensures tamper-proof device authentication, traceability, and verifiable treatment records, addressing regulatory compliance and liability concerns.

sequenceDiagram
    participant S as Surgeon (AR Glasses)
    participant C as Console (AI, DLT)
    participant R as Robotic Arm
    participant H as Handheld Device (Electrodes, Sensors)
    participant P as Patient (Nasal Cavity)
    participant B as Blockchain Ledger

    S->>C: Load Patient 3D Model & Treatment Plan
    C->>S: AR Overlay (Anatomy, Nerves, Lesions)
    C->>R: AI commands Robotic Arm for Device Positioning
    R->>H: Manipulates Handheld Device
    H->>P: End Effector & Elongate Body Contact Tissue
    H->>C: Transmit Real-time Sensor Data (Impedance, Temp, Contact)
    C->>R: AI refines R arm movement & Energy params
    C->>H: Deliver RF Energy (to End Effector & Elongate Body)
    H->>P: Therapeutic Modulation
    C->>S: Update AR Overlay (Actual Lesion, Temp Map)
    S->>C: Surgeon Approval / Override (recorded by AI)
    C->>B: Record Device ID, Consumables, Calibration, AI Decisions, Surgeon Sign-off

Derivative 19.5: The "Inverse" or Failure Mode (System) - Fail-Safe Diagnostic and Environmental Monitoring System

Enabling Description: This system is designed with inherent fail-safe mechanisms and operates primarily as a diagnostic and environmental monitoring platform, with all therapeutic energy delivery circuits completely isolated or permanently disabled. The energy generator in the console is replaced by a multi-channel biological signal analyzer (e.g., for ENG, EEG, impedance spectroscopy). The handheld device's electrodes are re-purposed as highly robust biosensors for collecting neural electrical activity and physiological parameters. In the event of any detected system anomaly, power failure, or critical parameter excursion (e.g., excessive force, unexpected impedance changes), the system immediately triggers a full power down of all active components, a mechanical retraction of the end effector, and initiates an emergency data dump to a secure, local storage. The system incorporates redundant, independent monitoring circuits and battery backups to ensure that diagnostic data collection and safe retraction functions are maintained even during primary system failures, guaranteeing patient safety and data integrity under all circumstances.

stateDiagram-v2
    state "System Standby" as Standby
    state "Diagnostic Mode" as Diagnostic
    state "Data Acquisition" as Acquire
    state "Anomaly Detected" as Anomaly
    state "Fail-Safe Shutdown" as Shutdown
    state "Emergency Data Dump" as Dump
    state "Device Retracted" as Retracted

    Standby --> Diagnostic: Initiate Diagnostic Session
    Diagnostic --> Acquire: Activate Biosensors
    Acquire --> Diagnostic: Continuous Monitoring

    Acquire --> Anomaly: System Fault OR Critical Parameter Exceeded
    Diagnostic --> Anomaly: Fault Detected

    Anomaly --> Shutdown: Trigger Full Power Down
    Shutdown --> Dump: Initiate Emergency Data Dump
    Dump --> Retracted: Mechanical Retraction of End Effector
    Retracted --> Standby: Safe State, Ready for Service

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Combination Prior Art Scenarios

1. US12089889 (Therapeutic Nasal Treatment Device) + DICOM Standard for Image Guidance:

   • Description: The system described in US12089889, including its console and handheld device, is integrated with existing medical imaging workflows by conforming to the Digital Imaging and Communications in Medicine (DICOM) standard. Pre-operative patient CT or MRI scans of the nasal cavity, formatted in DICOM, are loaded into the system's console. The console's GUI (Graphical User Interface) then provides real-time overlay of the handheld device's position (derived from optical tracking or electromagnetic tracking sensors on the device) onto the 3D DICOM image reconstruction. This allows the surgeon to visualize the exact placement of the end effector and elongate body electrodes relative to critical anatomical structures (e.g., turbinates, sphenopalatine foramen, nerves) during the procedure, enhancing precision and minimizing off-target energy delivery. Post-operative scans can also be compared in DICOM for treatment efficacy assessment.
   • Open-Source Standard: DICOM (Digital Imaging and Communications in Medicine)

2. US12089889 (Handheld Neuromodulation Device) + IEEE 802.11 (Wi-Fi) for Wireless Communication:

   • Description: The handheld neuromodulation device of US12089889 incorporates an embedded IEEE 802.11 (Wi-Fi) module for secure, real-time wireless communication with the neuromodulation console and/or a hospital's IT network. This eliminates the need for the physical cable (e.g., cable 120 in FIG. 1) for power, control, and data transmission. The Wi-Fi connection facilitates remote monitoring, software updates, and streaming of high-bandwidth data from the device's sensors (e.g., temperature, impedance, ENG signals) to the console's controller and evaluation/feedback algorithms. Power can be supplied via a high-capacity, rechargeable battery integrated within the handle, with inductive charging capability, further enhancing ergonomic design and reducing infection risk associated with cables. The communication uses standard Wi-Fi security protocols (e.g., WPA3) and medical device communication standards for data integrity and patient privacy.
   • Open-Source Standard: IEEE 802.11 (Wi-Fi)

3. US12089889 (Method for Improving Sleep) + HL7 Standard for Electronic Health Record (EHR) Integration:

   • Description: The method described in US12089889 for improving a patient's sleep by treating nasal conditions is integrated into a comprehensive healthcare information system via the Health Level Seven (HL7) standard. After a therapeutic nasal treatment procedure using the device, all relevant patient data, treatment parameters (e.g., energy levels, duration, electrode activation patterns), pre- and post-procedure symptom scores (e.g., NOSE score, sleep quality assessments), and outcomes are automatically formatted into HL7 messages. These messages are then transmitted and stored within the patient's Electronic Health Record (EHR) system. This ensures seamless data flow, improves continuity of care, facilitates clinical research, and enables automated billing and regulatory reporting, directly linking the treatment method to patient health outcomes within a standardized interoperable framework.
   • Open-Source Standard: Health Level Seven (HL7)

4. US12089889 (Energy Delivery System) + ROS (Robot Operating System) for Robotic Assistance:

   • Description: The therapeutic nasal treatment system of US12089889 is enhanced by incorporating a robotic arm, operating under the Robot Operating System (ROS) framework, to assist in the precise positioning and manipulation of the handheld neuromodulation device. The handheld device, specifically designed for robotic coupling, includes a ROS-compatible interface. A surgeon would initially guide the robotic arm, and then ROS-based control algorithms, leveraging real-time 3D optical tracking data of the nasal anatomy and device, would take over for micro-scale adjustments to ensure optimal end effector deployment and electrode contact. ROS provides modular software components for perception (e.g., camera/sensor integration), motion planning (e.g., collision avoidance, path optimization), and control (e.g., fine motor control of the robotic arm), enabling high-precision, repeatable treatment delivery. This system utilizes ROS's extensive libraries for robotic manipulation and sensor data processing to automate repetitive tasks or achieve superhuman precision in complex anatomical regions.
   • Open-Source Standard: Robot Operating System (ROS)