Derivative works — US Patent 12096973

Defensive Disclosure for US Patent 12096973

Date: 2026-05-18

This Defensive Disclosure document outlines derivative variations and combination prior art scenarios for US Patent 12096973, "Systems and methods for therapeutic nasal treatment using handheld device." The intent is to establish prior art that renders future incremental improvements or related inventions obvious or non-novel, thereby strengthening the defensive intellectual property posture.

Analysis of Independent Claim 1: Method for Improving Sleep by Treating Rhinitis, Congestion, and/or Rhinorrhea

Claim 1: 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, the method comprising delivering energy to one or more target sites within a sino-nasal cavity of the patient to disrupt multiple neural signals to, and/or result in local hypoxia of, mucus producing and/or mucosal engorgement elements, thereby reducing production of mucus and/or mucosal engorgement within a nose of the patient and reducing or eliminate one or more symptoms associated with at least one of rhinitis, congestion, and rhinorrhea to improve nasal breathability of the patient.

Derivative 1.1: Cryo-Modulation with Targeted Neural Blocking Agents

Enabling Description: This derivative method involves applying cryotherapeutic energy (e.g., via a cryo-probe delivering supercooled nitrogen gas or liquid nitrous oxide to achieve tissue temperatures below -40°C) to the target sites within the sino-nasal cavity, specifically associated with postganglionic parasympathetic fibers innervating the nasal mucosa. Concurrently or sequentially, a localized injection of a neural blocking agent, such as a botulinum toxin or a long-acting local anesthetic encapsulated in nanoparticles, is delivered directly to the cryo-modulated neural tissue via a micro-needle array integrated into the cryo-probe. The cryotherapy induces temporary neurolysis, making the tissue more permeable to the neural blocking agent, which then provides a sustained disruption of neural signals to mucus-producing glands and mucosal engorgement elements. The procedure targets foramina and microforamina of the palatine bone, aiming for precise, multi-point neural interruption without significant collateral thermal or mechanical damage.

graph TD
    A[Patient with Rhinitis] --> B{Deliver Cryo-Energy to Target Site};
    B --> C{Tissue Cooling to -40°C};
    C --> D{Local Neurolysis & Increased Tissue Permeability};
    D --> E{Deliver Neural Blocking Agent via Micro-Needle Array};
    E --> F{Sustained Neural Signal Disruption};
    F --> G{Reduced Mucus Production/Engorgement};
    G --> H{Improved Nasal Breathability & Sleep};

Derivative 1.2: Pulsed Focused Ultrasound (pFUS) for Non-Thermal Neural Modulation

Enabling Description: This method employs pulsed focused ultrasound (pFUS) delivered transnasally via a specialized transducer to target neural bundles within the sino-nasal cavity. Unlike thermal ablation, pFUS parameters are precisely controlled to induce non-thermal neuromodulatory effects, such as sonoporation or mechanotransduction, which temporarily or semi-permanently disrupt neural signal propagation without causing necrotic tissue damage. The pFUS energy is focused at identified target sites, such as the sphenopalatine ganglion (SPG) efferent fibers and branches innervating the inferior turbinate, to modulate their activity. Real-time elastography or acoustic radiation force impulse (ARFI) imaging is used to confirm precise targeting and monitor tissue response, ensuring that the acoustic pressure and pulse repetition frequency are within thresholds for neuromodulation rather than thermal ablation. This approach aims to reduce parasympathetic tone and mucosal engorgement.

graph TD
    A[Patient with Rhinitis] --> B{Position pFUS Transducer Transnasally};
    B --> C{Real-time Elastography/ARFI Imaging};
    C --> D{Target Neural Bundles (e.g., SPG efferents)};
    D --> E{Deliver Pulsed Focused Ultrasound};
    E --> F{Non-Thermal Neuromodulation (Sonoporation/Mechanotransduction)};
    F --> G{Disrupted Neural Signals};
    G --> H{Reduced Mucus Production/Engorgement};
    H --> I{Improved Nasal Breathability & Sleep};

Derivative 1.3: Photosensitizer-Enhanced Photodynamic Therapy (PDT)

Enabling Description: This method involves the systemic or localized administration of a photosensitizing agent (e.g., porfimer sodium or aminolevulinic acid) which selectively accumulates in hyperactive neural or vascular endothelial cells associated with rhinitis. After a predetermined incubation period, the target sites within the sino-nasal cavity (e.g., postganglionic parasympathetic fibers, submucosal glands, vascular plexus of turbinates) are illuminated with a specific wavelength of laser light (e.g., 630 nm for porfimer sodium) delivered via an optical fiber integrated into a nasal endoscope or device. The light activates the photosensitizer, generating reactive oxygen species that induce localized cellular damage, leading to disruption of neural signals, vascular occlusion, and subsequent local hypoxia. This selective phototoxicity reduces mucus production and mucosal engorgement.

sequenceDiagram
    participant P as Patient
    participant DS as Delivery System (Optical Fiber)
    participant LS as Laser Source
    participant PS as Photosensitizer
    P->PS: Systemic/Localized Administration
    Note over P: Photosensitizer accumulates at target sites
    P->DS: Insert Optical Fiber to Target Site
    DS->LS: Request Laser Activation
    LS->DS: Deliver Laser Light (e.g., 630nm)
    DS->P: Illuminate Target Sites
    P->PS: Photosensitizer Activation
    PS->P: Reactive Oxygen Species Generation
    Note over P: Cellular damage, neural/vascular disruption, local hypoxia
    P->P: Reduced Mucus/Engorgement
    P->P: Improved Nasal Breathability & Sleep

Derivative 1.4: Multi-Spectral Laser Ablation for Selective Tissue Targeting

Enabling Description: This method utilizes a multi-spectral laser system, integrated into a handheld nasal device, to selectively ablate different tissue components at target sites. For example, a 1470 nm diode laser can be used to target water-rich submucosal tissue and glands, causing bulk reduction and disrupting glandular function, while a 980 nm diode laser, absorbed by hemoglobin, can target microvasculature to induce local hypoxia and reduce engorgement. The device delivers these specific wavelengths through optical fibers that emerge at the tip of the end effector, with real-time spectroscopic feedback to identify tissue composition and guide laser parameter selection. This allows for precise, differential ablation of mucus-producing elements and engorgement elements based on their unique optical absorption profiles, minimizing damage to surrounding critical structures.

graph TD
    A[Patient with Rhinitis] --> B{Insert Handheld Device with Multi-Spectral Laser};
    B --> C{Real-time Spectroscopic Tissue Analysis};
    C --> D{Identify Tissue Type (Water-rich vs. Vascular)};
    D -- If Water-rich --> E{Deliver 1470nm Laser Energy};
    D -- If Vascular --> F{Deliver 980nm Laser Energy};
    E --> G{Disrupt Glandular Function & Reduce Bulk Tissue};
    F --> H{Induce Local Hypoxia & Reduce Engorgement};
    G & H --> I{Reduced Mucus Production/Engorgement};
    I --> J{Improved Nasal Breathability & Sleep};

Derivative 1.5: High-Frequency Reversible Electroporation (H-FIRE) for Non-Ablative Neuromodulation

Enabling Description: This method applies high-frequency irreversible electroporation (H-FIRE) pulse sequences to target neural structures in the nasal cavity. Instead of causing irreversible cell death (as in conventional IRE), H-FIRE uses short, high-voltage, bipolar or multi-polar electrical pulses at a high repetition rate (e.g., 500 kHz to 1 MHz) to temporarily increase cell membrane permeability or reversibly disrupt nerve conduction. This non-thermal, non-ablative approach selectively modulates neural function (e.g., inhibiting parasympathetic nerve activity) without causing significant tissue destruction. Electrodes on a multi-segment end effector are positioned at the sphenopalatine foramen region and along the inferior turbinate, and impedance monitoring ensures proper electrical coupling and real-time assessment of the neuromodulatory effect, allowing for titration of treatment to achieve desired symptom reduction.

flowchart TD
    A[Patient with Rhinitis] --> B{Position End Effector Electrodes at Target Sites};
    B --> C{Impedance Monitoring};
    C --> D{Deliver H-FIRE Pulses (High Freq, Bipolar/Multi-polar)};
    D --> E{Reversible Electroporation of Neural Membranes};
    E --> F{Temporary/Semi-Permanent Nerve Conduction Disruption};
    F --> G{Modulated Neural Signals (Reduced Parasympathetic Tone)};
    G --> H{Reduced Mucus Production/Engorgement};
    H --> I{Improved Nasal Breathability & Sleep};

Derivative 1.6: Targeted Gene Therapy or Neurotrophic Factor Delivery

Enabling Description: This advanced method involves delivering gene therapy vectors (e.g., adeno-associated virus, AAV) encoding inhibitory neuropeptides or enzymes that degrade neurotransmitters, or directly delivering neurotrophic factors that induce selective apoptosis of hyperactive parasympathetic neurons. The delivery is highly localized, using a microcatheter or microneedle array integrated into the elongate body of the device, placed directly into the target neural tissue near the sphenopalatine foramen or within the turbinate mucosa. The gene therapy expression or neurotrophic factor action leads to a sustained, precise reduction in parasympathetic innervation to the nasal mucosa, thereby decreasing mucus production and engorgement. This provides a long-term therapeutic effect.

graph TD
    A[Patient with Rhinitis] --> B{Identify Target Neural Tissue};
    B --> C{Position Microcatheter/Microneedle Array};
    C --> D{Deliver Gene Therapy Vector/Neurotrophic Factor};
    D --> E{Cellular Uptake & Expression of Inhibitory Agents OR Selective Neuronal Apoptosis};
    E --> F{Long-term Reduction in Parasympathetic Innervation};
    F --> G{Reduced Mucus Production/Engorgement};
    G --> H{Improved Nasal Breathability & Sleep};

Combination Prior Art Scenarios for Claim 1 (Method Claim):

US12096973 (Method Claim 1) + DICOM Standard (Digital Imaging and Communications in Medicine): The method of delivering energy to target sites for neuromodulation can be enhanced by integrating real-time pre-procedural and intra-procedural imaging data conforming to the DICOM standard. This includes importing patient-specific CT or MRI scans (DICOM files) into the treatment planning system to precisely identify neural pathways, foramina, and mucosal engorgement areas. During the procedure, live endoscopic video can be overlaid with the DICOM anatomical maps, providing augmented reality guidance for probe placement and energy delivery, ensuring accurate targeting and minimizing off-target effects. This open-source standard (DICOM) provides a robust framework for managing and integrating medical images to improve the accuracy and safety of the therapeutic method.
```
graph TD
    A[Patient CT/MRI (DICOM)] --> B{Treatment Planning System};
    B --> C{3D Anatomical Model};
    D[Live Endoscopic Video] --> E{Image Fusion & AR Guidance};
    C & E --> F{Real-time Probe Placement Guidance};
    F --> G{Deliver Energy to Target Sites (US12096973 Method)};
    G --> H{Neuromodulation/Hypoxia};
```
US12096973 (Method Claim 1) + OpenMRS (Open Medical Record System): The method's effectiveness can be tracked and optimized by integrating patient outcome data into an open-source Electronic Health Record (EHR) system like OpenMRS. Before and after treatment, patient-reported outcomes (PROs) related to sleep quality, nasal congestion, and rhinorrhea are recorded. Energy delivery parameters, target site locations, and intra-procedural feedback (e.g., impedance changes, temperature profiles) are automatically logged into the patient's OpenMRS record. This structured data allows for population-level analysis to identify optimal treatment protocols, correlate device parameters with long-term symptom relief, and support continuous improvement of the method, fostering evidence-based practice within an open data framework.
```
graph TD
    A[Patient (Rhinitis/Congestion)] --> B{US12096973 Method};
    B --> C{Energy Delivery & Neuromodulation};
    C --> D{Log Treatment Parameters (Energy, Location, Duration)};
    D --> E{OpenMRS Patient Record};
    F[Patient-Reported Outcomes (PROs)] --> E;
    E --> G{Outcome Tracking & Optimization Algorithms};
    G --> H{Improved Treatment Protocols};
```
US12096973 (Method Claim 1) + MQTT (Message Queuing Telemetry Transport) Protocol: To facilitate real-time communication and monitoring within a networked operating room or remote consultation scenario, the energy delivery method can be integrated with devices communicating via the MQTT protocol. The handheld device, console, and imaging systems publish real-time telemetry data (e.g., electrode temperature, power output, end effector position) to an MQTT broker. Authorized subscribers (e.g., a remote expert, an AI monitoring system, or a centralized control unit) can receive this data with low latency, enabling remote oversight, collaborative decision-making, and immediate alerts for critical events during the procedure. This ensures robust and secure data exchange for enhancing safety and efficacy of the treatment.
```
sequenceDiagram
    participant HD as Handheld Device
    participant CS as Console
    participant IS as Imaging System
    participant MQ as MQTT Broker
    participant AI as AI Monitoring System
    participant RE as Remote Expert
    HD->MQ: Publish (Temp, Power, Position)
    CS->MQ: Publish (Control Signals, Status)
    IS->MQ: Publish (Image Data Stream)
    MQ->AI: Subscribe (All Telemetry)
    MQ->RE: Subscribe (All Telemetry)
    AI->CS: Publish (Optimal Parameters/Alerts)
    RE->CS: Publish (Guidance/Instructions)
    CS->HD: Control Energy Delivery
    Note over HD: US12096973 Method Execution
```

Analysis of Independent Claim 10: Therapeutic System (Handheld Device)

Claim 10: A therapeutic system for improving a patient's sleep by treating at least one of rhinitis, congestion, and rhinorrhea, the system comprising: a handheld device comprising a handle, an elongate body extending therefrom, and a retractable and expandable multi-segment end effector operably associated with the elongate body, the end effector comprising: a first flexible segment configured in a deployed configuration to fit around at least a portion of a middle turbinate at an anterior position relative to a lateral attachment and a posterior-inferior edge of the middle turbinate and position one or more energy delivery elements into contact with one or more respective tissue locations associated with the middle turbinate; and a distal segment configured in a deployed configuration to position one or more energy delivery elements into contact with one or more respective tissue locations in a cavity at a posterior position relative to the lateral attachment and posterior-inferior edge of the middle turbinate.

Derivative 2.1: Bioresorbable Polymer End Effector with Integrated Thin-Film Electrodes

Enabling Description: The multi-segment end effector's flexible support elements (struts) are fabricated from a bioresorbable polymer, such as poly(L-lactide-co-glycolide) (PLGA) or polydioxanone (PDO), which degrades harmlessly in vivo over weeks or months. This eliminates the need for removal and reduces long-term foreign body sensation. The energy delivery elements are thin-film electrodes of conductive hydrogel (e.g., PEDOT:PSS embedded in a hydrogel matrix) or sputtered platinum/iridium, seamlessly integrated onto the surface of the polymer struts. These electrodes are micro-patterned using photolithography, providing precise control over ablation zones. The bioresorbable struts initially provide mechanical apposition to the nasal anatomy, ensuring optimal electrode contact, then gradually resorb, leaving only the therapeutic effect.

classDiagram
    class EndEffector {
        +BioR_Polymer_Struts
        +Thin_Film_Electrodes
        +ShapeMemoryActuator
        +ControlUnit
    }
    class BioR_Polymer_Struts {
        +PLGA_or_PDO_Material
        +SegmentedDesign
        +FlexibleDeployment()
        +InVivoDegradation()
    }
    class Thin_Film_Electrodes {
        +PEDOT_PSS_Hydrogel | Pt/Ir_Sputtered
        +MicroPatternedGeometry
        +EnergyDelivery()
        +TissueContact()
    }
    class ShapeMemoryActuator {
        +NiTi_Wires
        +ThermalExpansionControl()
        +RetractionMechanism()
    }
    EndEffector <|-- BioR_Polymer_Struts
    EndEffector <|-- Thin_Film_Electrodes
    EndEffector <|-- ShapeMemoryActuator

Derivative 2.2: Miniaturized End Effector for Pediatric Use with Fluidic Control

Enabling Description: This derivative features a miniaturized multi-segment end effector, specifically scaled for pediatric nasal anatomies (e.g., overall diameter in retracted state < 2.0 mm). The flexible segments are made from ultra-fine nitinol wires, enabling highly conformable deployment within delicate structures. Instead of conventional electrodes, it incorporates micro-nozzles for precise fluidic delivery of a cryo-spray (e.g., highly localized evaporative cooling with a medical-grade coolant) or a chemical neuromodulator. Deployment and fluidic control are managed via a fine-pitch lead screw mechanism in the handle, offering sub-millimeter precision. A separate lumen within the elongate body provides continuous low-flow irrigation to clear mucus and ensure clear visualization.

graph TD
    A[Handle (Fine-Pitch Lead Screw)] --> B[Elongate Body (Micro-Lumen)];
    B --> C{Miniaturized End Effector (Nitinol Struts)};
    C --> D[Micro-Nozzles];
    D -- Cryo-Spray/Chemo-Modulator --> E[Target Pediatric Tissue];
    B --> F[Irrigation Lumen];
    F --> G[Low-Flow Irrigation];
    G --> H[Clear Visualization];
    C --> I[Precise Fluidic Delivery];
    I --> J{Neuromodulation/Symptom Reduction};

Derivative 2.3: Robotic Arm-Assisted System with Haptic Feedback and AR Guidance

Enabling Description: This system integrates the handheld device (elongate body, multi-segment end effector) with a stereotactic robotic arm. The handheld device is cradled by the robotic arm, which provides enhanced stability and precision beyond human capabilities. The system incorporates an Augmented Reality (AR) display for the surgeon, overlaying real-time 3D endoscopic views with pre-operative CT/MRI data and planned treatment zones. Haptic feedback is provided through the robotic arm to the surgeon's hand, simulating tissue resistance, proximity to critical structures, and successful electrode contact, derived from real-time impedance sensing at the end effector. This combination allows for highly precise, image-guided deployment and energy delivery, particularly beneficial for complex or variable anatomies.

flowchart TD
    A[Pre-operative CT/MRI] --> B{3D Anatomical Reconstruction};
    C[Handheld Device (End Effector)] --> D{Robotic Arm Interface};
    E[Real-time Endoscopic Video] --> F{AR Display (Surgeon)};
    B & E --> F;
    F --> G{Surgeon Input (Manual + Haptic Feedback)};
    D --> C;
    C --> H{Real-time Impedance/Temp Sensing};
    H --> G;
    G --> I{Precise Energy Delivery};
    I --> J{Therapeutic Modulation};

Derivative 2.4: Self-Adjusting Electrodes with Integrated Micro-Thermal Sensors

Enabling Description: The energy delivery elements (electrodes) on both the first and second flexible segments are constructed with bimetallic strips or shape memory polymer composites that self-adjust their curvature and apposition force based on local tissue temperature. Each electrode is paired with an embedded micro-thermal sensor (e.g., thin-film thermistor). During energy delivery, if a localized "hot spot" develops, the electrode's geometry subtly changes, reducing its contact area or increasing its standoff distance from the overheated tissue, thereby automatically regulating energy density and preventing overheating. This passive, integrated feedback mechanism enhances safety and minimizes collateral damage, even in variable tissue impedance environments.

graph LR
    A[Multi-Segment End Effector] --> B[Flexible Segment 1];
    A --> C[Flexible Segment 2];
    B --> D[Self-Adjusting Electrode with Micro-Thermal Sensor];
    C --> D;
    D --> E{Energy Delivery};
    E --> F{Local Tissue Heating};
    F -- Temp > Threshold --> D;
    D --> G{Electrode Self-Adjustment (Reduced Contact/Increased Standoff)};
    G --> H{Regulated Energy Density};
    H --> I{Minimized Collateral Damage};

Derivative 2.5: Modular End Effector with Interchangeable Therapeutic Modalities

Enabling Description: The therapeutic system features a modular design where the multi-segment end effector is a detachable cartridge. This allows a clinician to quickly exchange end effectors, each pre-loaded with a different therapeutic modality, onto the same elongate body and handle assembly. Examples of interchangeable modalities include: an RF ablation end effector, a cryotherapy end effector (with integrated fluidic lines), a low-power laser delivery end effector (with optical fibers), or a drug delivery end effector (with micro-needles and a drug reservoir). This modularity offers physicians the flexibility to select the most appropriate treatment for patient-specific anatomies and conditions, enhancing the versatility of the handheld device.

flowchart LR
    A[Handheld Device Handle + Elongate Body] -- Accepts --> B{Modular End Effector Interface};
    B -- Connects To --> C[RF Ablation End Effector];
    B -- Connects To --> D[Cryotherapy End Effector];
    B -- Connects To --> E[Laser Delivery End Effector];
    B -- Connects To --> F[Drug Delivery End Effector];
    C -- Provides --> G[RF Energy Delivery];
    D -- Provides --> H[Cryo-Treatment];
    E -- Provides --> I[Laser Photomodulation];
    F -- Provides --> J[Localized Drug Delivery];
    A -- Controls --> G, H, I, J;

Combination Prior Art Scenarios for Claim 10 (System Claim):

US12096973 (System Claim 10) + USB-C Power Delivery Standard: The handheld device, specifically its handle and elongate body, can be adapted to receive power and transmit data via a universal USB-C connection, adhering to the USB-C Power Delivery (PD) standard. This replaces proprietary power cables and connectors, offering interoperability with a wide range of standard power sources (e.g., hospital power bricks, portable battery packs). The USB-C connection would also facilitate high-speed data transfer of sensor feedback (temperature, impedance) from the end effector to the console for real-time monitoring and control, streamlining device connectivity and reducing equipment complexity in clinical settings.
```
graph LR
    A[Handheld Device] --> B[USB-C Connector];
    B --> C[USB-C Power Delivery (PD) Source];
    B --> D[USB-C Data Link];
    D --> E[Therapeutic Console];
    E --> F[Energy Generator];
    E --> G[Controller];
    A --> H[Elongate Body];
    H --> I[End Effector (Sensors/Electrodes)];
    I --> D;
```
US12096973 (System Claim 10) + IEC 60601 Standard (Medical Electrical Equipment): The entire therapeutic system, including the handheld device, handle, elongate body, and end effector, is designed and certified to comply with the IEC 60601 series of standards for the safety and essential performance of medical electrical equipment. This includes specific requirements for electrical safety (e.g., insulation, leakage currents), mechanical safety (e.g., patient protection mechanisms), electromagnetic compatibility (EMC), and usability. Adherence to this widely adopted open standard ensures the device meets fundamental safety and performance criteria recognized globally, directly improving the reliability and clinical acceptance of the disclosed system.
```
stateDiagram
    state IEC60601_Compliance {
        [*] --> Electrical_Safety
        Electrical_Safety --> Mechanical_Safety
        Mechanical_Safety --> EMC_Compliance
        EMC_Compliance --> Usability_Requirements
        Usability_Requirements --> [*]
    }
    Handheld_Device -- Adheres to --> IEC60601_Compliance
    Elongate_Body -- Adheres to --> IEC60601_Compliance
    End_Effector -- Adheres to --> IEC60601_Compliance
```
US12096973 (System Claim 10) + Apache Kafka (Distributed Streaming Platform): For large-scale deployment and continuous improvement across multiple clinical sites, the therapeutic system's operational data (device usage, energy profiles, patient demographics, aggregated outcomes) can be streamed to a centralized analytical platform using Apache Kafka. Each handheld device and its console can act as a Kafka producer, sending real-time operational metrics and anonymized treatment data. This distributed streaming architecture enables robust, scalable collection of data for fleet management, predictive maintenance, and machine learning models that optimize device performance and patient selection for the treatment of rhinitis, congestion, and rhinorrhea.
```
graph LR
    HD1[Handheld Device 1] -- Produces Data --> K[Apache Kafka Cluster];
    CS1[Console 1] -- Produces Data --> K;
    HDn[Handheld Device n] -- Produces Data --> K;
    CSn[Console n] -- Produces Data --> K;
    K --> AP[Analytical Platform (ML Models)];
    AP --> DD[Data Dashboard (Performance/Outcomes)];
    AP --> PI[Predictive Insights (Maintenance/Treatment)];
    DD --> HD1;
    DD --> CS1;
```

Analysis of Independent Claim 19: Handheld Device

Claim 19: A handheld device for delivering energy to a sino-nasal cavity of a patient, the handheld device comprising: an ergonomically designed handle including a grip portion which provides ambidextrous use for both left and right handed use and conforms to hand anthropometrics to allow for at least one of an overhand grip style and an underhand grip style during use in a procedure, the handle including one or more recesses configured to naturally receive one or more of an operator's fingers; an elongate body extending from the handle, the elongate body including one or more electrodes provided on one or more respective portions along a length thereof and configured to deliver energy to tissue associated with an inferior turbinate of the patient; and a retractable and expandable multi-segment end effector operably associated with the elongate body, the end effector including one or more electrodes and configured to deliver energy to tissue associated with a sphenopalatine foramen within the sino-nasal cavity of the patient; wherein the handle further includes multiple user-operated mechanisms, including at least a first mechanism for deployment of the end effector from the retracted configuration to the expanded deployed configuration and a second mechanism for controlling of energy output by the end effector, the user inputs for the first and second mechanisms positioned a sufficient distance to one another to allow for simultaneous one-handed operation of both user inputs during a procedure.

Derivative 3.1: Haptic Feedback-Enabled Ergonomic Handle with Biometric Authentication

Enabling Description: The ergonomically designed handle incorporates advanced haptic feedback actuators (e.g., linear resonant actuators or voice coil motors) that provide real-time tactile cues to the operator. This feedback is generated in response to tissue impedance changes, proximity to critical structures (e.g., bone, nerve bundles detected by sensing electrodes), and optimal apposition force of the end effector. The handle's grip portion is constructed from a medical-grade, textured elastomer providing enhanced grip and comfort, and features dynamically adjustable recesses that conform to the operator's individual hand anatomy via micro-actuators, activatable via a quick calibration process. A fingerprint scanner or palm vein sensor is integrated into the grip for biometric authentication, ensuring only authorized personnel can operate the high-energy device and automatically linking procedure data to the specific operator.

graph TD
    A[Operator Finger/Palm] --> B{Biometric Sensor (Fingerprint/Vein)};
    B --> C{Authentication Module};
    C -- Authenticated --> D[Handle Control Unit];
    C -- Unauthenticated --> E[Device Lockout];
    D --> F{Dynamically Adjustable Recesses (Micro-Actuators)};
    D --> G{Haptic Feedback Actuators};
    H[Tissue Impedance/Proximity Sensors] --> G;
    I[Elongate Body & End Effector] --> H;
    G & F --> J[Enhanced Operator Control & Comfort];
    J --> K[Energy Delivery & Deployment Mechanisms];

Derivative 3.2: Wireless Power Transfer and Inductive Charging for Enhanced Mobility

Enabling Description: The handheld device is completely wireless, eliminating the cable connection to a console for power. It features an integrated high-capacity, medical-grade lithium-ion battery with a wireless power transfer coil embedded in the handle. The console includes a corresponding inductive charging pad. During standby or between procedures, the device is placed on the pad for charging. During operation, the battery powers the device, and real-time operational data (e.g., electrode parameters, end effector position, sensor readings) is transmitted wirelessly via a secure, low-latency Wi-Fi or Bluetooth Low Energy (BLE) module to the console. This design enhances mobility in the operating room, reduces entanglement, and improves sterility by minimizing external connections.

flowchart TD
    A[Handheld Device] --> B[Integrated Li-Ion Battery];
    B --> C[Wireless Power Coil (Rx)];
    C -- Inductive Charging --> D[Console Inductive Pad (Tx)];
    A --> E[Wireless Data Module (Wi-Fi/BLE)];
    E -- Secure Data Link --> F[Console Processing Unit];
    F --> G[Energy Generator];
    F --> H[Deployment Control];
    A --> I[Elongate Body & End Effector];
    I --> E;
    I --> B;

Derivative 3.3: AI-Driven Voice Command Interface for User Mechanisms

Enabling Description: The handle's user-operated mechanisms for deployment and energy control are augmented with an AI-driven voice command interface. Embedded microphones in the handle capture the surgeon's voice commands (e.g., "End Effector Deploy," "Energy On, Level 3," "Retract Half"). A local, edge-AI processor within the handle processes these commands, utilizing natural language processing (NLP) and speech recognition optimized for medical terminology, to actuate the respective mechanisms. This minimizes the need for manual button presses during critical procedural steps, freeing the surgeon's hands for delicate manipulation and potentially reducing cognitive load. A small, integrated display or LED indicator provides visual confirmation of voice commands.

sequenceDiagram
    participant S as Surgeon
    participant HD as Handheld Device
    participant AI as Edge-AI Processor
    participant DM as Deployment Mechanism
    participant EM as Energy Mechanism
    S->HD: Voice Command (e.g., "Deploy End Effector")
    HD->AI: Audio Input
    AI->AI: NLP & Speech Recognition
    AI->DM: Actuate Deployment
    AI->HD: Visual/Auditory Confirmation
    S->HD: Voice Command (e.g., "Energy On, Level 3")
    HD->AI: Audio Input
    AI->AI: NLP & Speech Recognition
    AI->EM: Set Energy Output
    AI->HD: Visual/Auditory Confirmation
    Note over HD: Energy Delivery to Tissue

Derivative 3.4: Modular Elongate Body for Variable Stiffness and Curvature

Enabling Description: The elongate body is a modular, multi-segment assembly, where each segment has independently controllable stiffness and/or pre-set curvature. The segments are made of interlocking, flexible polymer rings with embedded shape memory alloy (SMA) wires (e.g., nitinol) or micro-braids. By applying specific electrical currents or thermal profiles to the SMA wires, the operator can dynamically alter the stiffness of individual segments (e.g., from highly flexible for navigation to rigid for stable apposition) or induce specific curvatures in real-time. This allows for unparalleled maneuverability through tortuous nasal anatomies and precise positioning of both the elongate body's and the end effector's electrodes, without requiring multiple pre-shaped shafts. Control is integrated into the handle's user mechanisms, potentially via a joystick or touch-sensitive interface.

stateDiagram
    state "Elongate Body States" {
        Flexible: NavigationMode
        Rigid: AppositionMode
        Curved_Left: SteerLeft
        Curved_Right: SteerRight
        
        [*] --> Flexible
        Flexible --> Rigid: Apply Current (SMA)
        Rigid --> Flexible: Release Current (SMA)
        Flexible --> Curved_Left: Apply Current (SMA Left Side)
        Flexible --> Curved_Right: Apply Current (SMA Right Side)
        Curved_Left --> Flexible
        Curved_Right --> Flexible
    }
    Handle_Control --> "Elongate Body States"

Derivative 3.5: Multi-Modal Sensing Integration on Elongate Body Electrodes

Enabling Description: The electrodes provided on the elongate body, in addition to delivering energy, are also capable of multi-modal sensing. Each electrode, or a subset thereof, functions as a combined impedance sensor, a temperature sensor (e.g., via a miniaturized thermistor or differential impedance), and a local nerve stimulation/recording electrode. The system automatically cycles between energy delivery and sensing modes. Before energy delivery, low-level electrical pulses are applied to stimulate nerves, and electromyography (EMG) or evoked potential responses are recorded to map neural pathways and confirm safe distances from non-target nerves. During energy delivery, real-time impedance and temperature feedback ensure precise control and prevent overheating. This integrated sensing capability on the elongate body's electrodes provides comprehensive tissue characterization and enhanced safety during treatment of the inferior turbinate.

graph TD
    A[Elongate Body Electrodes] --> B{Impedance Sensing};
    A --> C{Temperature Sensing};
    A --> D{Nerve Stimulation / Recording};
    B & C & D --> E[Multi-Modal Sensing Data];
    E --> F{Console Processing Unit};
    F -- Pre-treatment --> G{Neural Mapping / Safety Zone Delimitation};
    F -- Intra-treatment --> H{Energy Control Feedback};
    H --> I[Energy Delivery to Inferior Turbinate];
    G --> I;

Combination Prior Art Scenarios for Claim 19 (Handheld Device Claim):

US12096973 (Handheld Device Claim 19) + ROS (Robot Operating System): The control architecture for the deployment and energy mechanisms within the handheld device and its console can be built upon the open-source Robot Operating System (ROS) framework. ROS nodes would manage individual components such as actuator control for end effector deployment, energy generator parameters, and sensor data acquisition from electrodes. This modular, message-passing architecture allows for flexible development, easy integration of new features (e.g., advanced control algorithms, new sensors), and robust communication between the device and its various subsystems. It also supports simulation environments for testing and validation, fostering rapid iteration and reliable system design.
```
graph TD
    HD[Handheld Device ROS Node] -- Pub/Sub --> EB[Elongate Body Control Node];
    HD -- Pub/Sub --> EE[End Effector Control Node];
    HD -- Pub/Sub --> UM[User Mechanism Interface Node];
    CS[Console ROS Node] -- Pub/Sub --> HD;
    EB --> ES[Electrode Sensing Node];
    EE --> EGE[Energy Generator Interface Node];
    EGE --> EE;
    UM --> DM[Deployment Actuator];
    UM --> EC[Energy Control Interface];
    DM & EC & ES & EGE --> CS;
```
US12096973 (Handheld Device Claim 19) + Zigbee (IEEE 802.15.4 Standard): For wireless communication between the handheld device and the console, particularly in environments where low power consumption and mesh networking capabilities are desirable, the Zigbee protocol (based on IEEE 802.15.4) can be utilized. This would enable the device to transmit sensor data (e.g., temperature, impedance, device status) to the console and receive control commands without a direct cable connection. The mesh networking capability could also allow for communication with other Zigbee-enabled devices in the operating room, such as a remote display or an automated sterilization unit, creating a connected ecosystem with minimal energy overhead.
```
graph TD
    HD[Handheld Device] -- Wireless (Zigbee) --> C[Console (Zigbee Coordinator)];
    C -- Wireless (Zigbee) --> RD[Remote Display];
    C -- Wireless (Zigbee) --> ASU[Automated Sterilization Unit];
    HD --> S[Sensors (Temp, Impedance)];
    HD --> EC[Electrodes/Energy Control];
    HD --> DM[Deployment Mechanisms];
    S & EC & DM --> HD;
```
US12096973 (Handheld Device Claim 19) + GNU Octave (Numerical Computation Software): The console's control system, particularly for advanced energy delivery algorithms and real-time feedback processing, can leverage open-source numerical computation software like GNU Octave. This allows for the development and execution of complex algorithms for impedance feedback control, tissue heating models, and nerve mapping analysis without relying on proprietary software environments. Clinicians or researchers could easily develop and deploy custom treatment protocols using Octave's scripting capabilities, fostering innovation and transparency in the device's operational logic. The console would run an embedded Octave interpreter or compiler for real-time execution.
```
flowchart TD
    A[Handheld Device (Electrode Data)] --> B{Console Input Module};
    B --> C[GNU Octave Runtime Environment];
    C --> D{Custom Control Algorithms (Octave Script)};
    D --> E{Real-time Feedback Processing};
    E --> F{Energy Generator Control};
    E --> G{Deployment Mechanism Control};
    F & G --> A;
```

Analysis of Independent Claim 20: Method of Treating Rhinosinusitis

Claim 20: A method of treating rhinosinusitis using the handheld device of claim 19, the method comprising: inserting the multi-segment end effector into the sino-nasal cavity of the patient, wherein the elongate body carries a first set of electrodes and the multi-segment end effector carries a second set of electrodes; positioning the multi-segment end effector at a first target site associated with a sphenopalatine foramen within the sino-nasal cavity of the patient; simultaneously positioning a portion of the elongate body at a second, separate target site associated with an inferior turbinate within the sino-nasal cavity of the patient; delivering energy from the first set of electrodes to tissue associated with the inferior turbinate at a level sufficient to reduce engorgement of tissue associated with the inferior turbinate to thereby increase volumetric flow through a nasal passage of the patient; and delivering energy from the second set of electrodes to the first target site at a level sufficient to therapeutically modulate postganglionic parasympathetic nerves innervating nasal mucosa at microforamina of a palatine bone of the patient.

Derivative 4.1: Automated Dual-Site Sequential Pulsed RF Ablation with Adaptive Cooling

Enabling Description: This method refines the dual-site treatment by implementing an automated sequential pulsed radiofrequency (RF) ablation protocol with integrated adaptive cooling. After positioning, the system first delivers pulsed RF energy (e.g., 5-second pulse, 2-second pause) from the first set of electrodes to the inferior turbinate. During the pause, a localized cooling saline flush is administered via an auxiliary lumen in the elongate body to mitigate surface heating while maintaining deep tissue ablation. Once the inferior turbinate treatment is complete (confirmed by real-time impedance feedback and volumetric flow improvement), the system automatically transitions to deliver pulsed RF from the second set of electrodes to the sphenopalatine foramen (SPF) region, with parameters optimized for precise neural modulation. The system dynamically adjusts pulse duration, power, and cooling rates at each site based on real-time tissue impedance, temperature, and pre-programmed safety algorithms.

sequenceDiagram
    participant S as Surgeon
    participant HD as Handheld Device
    participant C as Console
    participant EB as Elongate Body (1st Electrodes)
    participant EE as End Effector (2nd Electrodes)

    S->HD: Insert & Position Device
    C->EB: Start Pulsed RF (Inferior Turbinate)
    C->HD: Deliver Cooling Saline Flush
    EB->C: Real-time Impedance/Temp/Flow
    loop Inferior Turbinate Treatment
        C->EB: Adjust RF Parameters
        C->HD: Continue Cooling
    end
    C->C: Inferior Turbinate Treatment Complete
    C->EE: Start Pulsed RF (SPF Region)
    EE->C: Real-time Impedance/Temp
    loop SPF Region Treatment
        C->EE: Adjust RF Parameters
    end
    C->C: SPF Region Treatment Complete
    C->HD: Device Retraction Instruction

Derivative 4.2: Photo-Acoustic Imaging Guided Localized Drug Delivery for Nerve Modulation

Enabling Description: This method combines photo-acoustic imaging (PAI) for real-time anatomical and functional guidance with localized drug delivery. The handheld device incorporates miniaturized PAI transducers and a laser source. Before drug delivery, PAI is used to visualize nerve bundles, microforamina, and vascular structures around the SPF and inferior turbinate by detecting ultrasonic waves generated from laser-induced thermal expansion. This provides highly detailed, label-free anatomical and functional maps. Once target nerves are precisely identified, a micro-catheter, extending from the end effector, delivers a focused bolus of a neuro-modulating pharmaceutical agent (e.g., a selective antagonist for cholinergic receptors or a growth factor to induce nerve atrophy) directly to the target neural pathways, guided by the real-time PAI feedback. Simultaneously, the elongate body's electrodes could be used for low-level electrical stimulation to cause temporary vasoconstriction of the inferior turbinate, rather than ablation, for acute congestion relief.

graph TD
    A[Patient Sino-Nasal Cavity] --> B{Handheld Device with PAI};
    B --> C{PAI Transducers & Laser Source};
    C --> D{Real-time Photo-Acoustic Imaging (Neural & Vascular)};
    D --> E{Precise Identification of Target Nerves/Microforamina};
    E --> F{Micro-Catheter Drug Delivery (Neuro-Modulator)};
    G[Elongate Body Electrodes] --> H{Low-level Electrical Stimulation (Inferior Turbinate)};
    F --> I{Therapeutic Nerve Modulation (SPF)};
    H --> J{Acute Vasoconstriction (Inferior Turbinate)};
    I & J --> K{Reduced Rhinosinusitis Symptoms & Improved Sleep};

Derivative 4.3: High-Intensity Focused Ultrasound (HIFU) for Non-Invasive Dual-Site Modulation

Enabling Description: This method employs non-invasive High-Intensity Focused Ultrasound (HIFU) delivered from external transducers (e.g., mounted on a head-frame or integrated into a custom nasal applicator) rather than internal electrodes. The HIFU beams are precisely steered and focused onto the external surface of the palatine bone to target the postganglionic parasympathetic nerves at the microforamina associated with the SPF region. Simultaneously, a separate HIFU beam or a different set of transducers focuses energy onto the inferior turbinate region (transcutaneously or transorally) to induce controlled thermal necrosis or modulate vascular tone to reduce engorgement. Real-time MRI-thermometry or ultrasound imaging guides the focusing and monitors the temperature at both target sites, ensuring non-invasive, precise, and controlled energy delivery. This eliminates the need for internal probes or electrodes for primary energy delivery.

flowchart TD
    A[Patient (Rhinosinusitis)] --> B{External HIFU Transducer Array};
    B --> C{Real-time MRI-Thermometry/Ultrasound Guidance};
    C --> D{HIFU Beam 1 (SPF Region)};
    C --> E{HIFU Beam 2 (Inferior Turbinate)};
    D --> F{Therapeutic Nerve Modulation (SPF)};
    E --> G{Controlled Thermal Necrosis/Vascular Modulation (Inferior Turbinate)};
    F & G --> H{Reduced Rhinosinusitis Symptoms & Improved Sleep};

Derivative 4.4: Adaptive Cryo-Therapy for Inferior Turbinate and RF Micro-Ablation for SPF

Enabling Description: This method employs a combination of adaptive cryo-therapy for the inferior turbinate and precise RF micro-ablation for the sphenopalatine foramen (SPF) region. The elongate body incorporates a cryo-probe that delivers a controlled, circulating cryogen (e.g., argon gas for Joule-Thomson effect) to freeze the tissue of the inferior turbinate, reducing its bulk and engorgement. The cryo-probe includes integrated thermistors for real-time temperature monitoring and adaptive feedback to maintain optimal freezing temperatures (e.g., -60°C to -80°C) while avoiding excessive tissue damage. Simultaneously, the multi-segment end effector, positioned at the SPF region, delivers extremely low-power, high-frequency RF pulses through its micro-electrodes. These micro-electrodes are designed to create very small, superficial lesions (micro-ablations) specifically targeting nerve fascicles exiting the microforamina, minimizing thermal spread and collateral damage to surrounding bone or vasculature.

graph TD
    A[Patient Sino-Nasal Cavity] --> B{Handheld Device Insertion};
    B --> C{Elongate Body (Cryo-probe) at Inferior Turbinate};
    B --> D{End Effector (Micro-RF Electrodes) at SPF Region};
    C --> E{Deliver Adaptive Cryo-Therapy};
    E --> F{Real-time Temp Monitoring (Inferior Turbinate)};
    F --> G{Reduce Inferior Turbinate Engorgement/Bulk};
    D --> H{Deliver Low-Power, High-Frequency RF Micro-Ablation};
    H --> I{Precisely Target Nerve Fascicles (SPF)};
    G & I --> J{Reduce Rhinosinusitis Symptoms & Improve Sleep};

Derivative 4.5: Blockchain-Verified Treatment Protocol with AI Optimization

Enabling Description: This method integrates the treatment protocol with a secure, blockchain-verified system for logging and optimizing procedures. Each step of the method (device insertion, positioning, energy delivery parameters, patient response) is cryptographically logged as a transaction on a private blockchain network accessible to authorized medical personnel and regulatory bodies. An AI module, fed by this secure, anonymized global dataset, continuously analyzes successful treatment outcomes and device parameters. Before each procedure, the AI provides optimized energy delivery settings and positioning guidance tailored to the patient's specific anatomical profile and disease severity, derived from the blockchain data. After treatment, the AI evaluates the actual parameters against the predicted optimal settings, refining future recommendations and ensuring compliance with the verified protocol.

sequenceDiagram
    participant S as Surgeon
    participant HD as Handheld Device
    participant C as Console
    participant AI as AI Optimization Module
    participant BC as Blockchain Network

    S->C: Input Patient Data
    C->AI: Request Optimized Protocol
    AI->BC: Query Historical Treatment Data
    BC->AI: Return Anonymized Outcomes
    AI->C: Provide Optimized Parameters (Energy, Position, Duration)
    S->HD: Insert & Position Device (Guided by C)
    S->C: Confirm Position
    C->BC: Log Position Transaction
    C->HD: Deliver Energy (Optimized Parameters)
    HD->C: Real-time Feedback (Temp, Impedance)
    C->BC: Log Energy Delivery Transaction
    C->AI: Submit Real-time Feedback
    AI->C: Adaptive Adjustments
    S->C: Procedure Complete
    C->BC: Log Final Outcome Transaction

Combination Prior Art Scenarios for Claim 20 (Method of Treating Rhinosinusitis):

US12096973 (Method Claim 20) + FHIR Standard (Fast Healthcare Interoperability Resources): The method of treating rhinosinusitis can be integrated with hospital information systems using the FHIR standard for interoperable exchange of healthcare information. Pre-procedural patient data (medical history, imaging reports, allergy status) is retrieved from the EHR via FHIR APIs. Intra-procedural data, such as electrode power, temperature, duration of energy delivery, and real-time sensor readings from the device, is structured into FHIR resources (e.g., Device, Observation, Procedure) and securely transmitted back to the patient's electronic health record. This ensures seamless data flow, improves clinical decision-making, and facilitates comprehensive audit trails for regulatory compliance, leveraging a widely adopted open standard for healthcare data.
```
graph TD
    A[EHR System (FHIR Compliant)] --> B{FHIR API Query (Patient Data)};
    B --> C{Console (Pre-Proc Planning)};
    D[Handheld Device (Sensors/Energy Delivery)] --> E{FHIR Resource Creation (Proc Data)};
    E --> F{FHIR API Update (EHR)};
    C --> D;
    F --> G[Improved Patient Record & Analytics];
```
US12096973 (Method Claim 20) + ONVIF Standard (Open Network Video Interface Forum): For enhanced visual guidance and post-procedural review, the endoscopic camera integrated into the handheld device or a separate visualization endoscope can adhere to the ONVIF standard for IP-based video surveillance. This allows the live video feed from the nasal cavity to be streamed directly over the network to multiple displays, recording systems, and remote viewing platforms, offering high interoperability. The ONVIF standard also defines interfaces for camera control (e.g., zoom, focus) and metadata, which can be enriched with treatment parameters from the device console. This enables standardized video archiving and facilitates collaborative surgical environments or remote assistance during complex rhinosinusitis treatments.
```
flowchart TD
    A[Endoscopic Camera (ONVIF Compliant)] --> B{IP Network (Streaming Video)};
    B --> C[Operating Room Display];
    B --> D[Remote Viewing Station];
    B --> E[Video Recording System];
    F[Console (Treatment Parameters)] --> E;
    F --> D;
    A -- Delivers Video --> G[Target Sites in Nasal Cavity];
    G -- Guides --> H[Handheld Device Positioning/Energy];
```
US12096973 (Method Claim 20) + OpenTelemetry (Cloud-Native Observability Framework): To monitor the performance and health of the therapeutic system in a distributed clinical environment, the method can integrate with OpenTelemetry. The handheld device and console generate telemetry data (metrics, traces, logs) regarding energy delivery cycles, device errors, network latency, and processing times. These telemetry signals are collected by OpenTelemetry agents and exported to a backend analysis system. This open-source framework provides standardized, vendor-agnostic means for instrumenting the entire system, enabling proactive identification of operational issues, performance bottlenecks, and deviations from optimal treatment protocols, ensuring high reliability and efficacy of the rhinosinusitis treatment method.
```
graph TD
    A[Handheld Device] --> B{OpenTelemetry Agent};
    C[Console] --> D{OpenTelemetry Agent};
    B --> E[OpenTelemetry Collector];
    D --> E;
    E --> F[Backend Analysis System (Metrics, Traces, Logs)];
    F --> G[Performance Monitoring Dashboard];
    F --> H[Alerting & Anomaly Detection];
    G & H --> I[System Optimization & Maintenance];
```