Derivative works — US Patent 11589970

Defensive Disclosure: Advanced Intraoral Devices with Enhanced Features

Introduction:

This defensive disclosure aims to broaden the scope of existing prior art related to intraoral dental suction and isolation mouthpieces, building upon the foundational concepts described in US Patent 11589970. The objective is to pre-empt future patent claims by demonstrating the obviousness or lack of novelty of various incremental improvements across material science, operational parameters, cross-domain applications, integration with emerging technologies, and alternative design principles including failure modes.

Core Technical Elements of US11589970 for Derivation:

US Patent 11589970 focuses on an intraoral device comprising:

A main body portion configured as a pocket with an interior space, defined by a first wall, a second wall, and a connecting wall. The second wall notably includes a wave-shaped bridge structure with integral protrusions that extend towards the first wall but are not attached, ensuring separation during suction (Claim 1, 18).
An integral suction connector extending from the main body, with a cavity communicating with the interior space (Claim 1, 18).
A mouth prop molded in one piece, through which or past which the suction connector extends, facilitating bite-block functionality and detachability (Claim 1, 18).

Derivative Variations and Enabling Descriptions

1. Material & Component Substitution

Derivative 1.1: Multi-Material Mouthpiece with Biocompatible Thermoplastic Elastomer (TPE) and Shape Memory Alloy Bridge Structure

Enabling Description: This derivative proposes a mouthpiece where the main body, cheek retractor, and suction connector are co-molded from a flexible, medical-grade Biocompatible Thermoplastic Elastomer (TPE), specifically a styrene-ethylene/butylene-styrene (SEBS) block copolymer with a shore hardness of 30-40A, exhibiting high elasticity and chemical resistance to common dental sterilants. The wave-shaped bridge structure, instead of being integral TPE, is fabricated from a Nickel-Titanium (NiTi) shape memory alloy (e.g., Nitinol, ASTM F2063-12 grade 1), laser-cut into the specified wave pattern and embedded within the TPE during injection molding or inserted post-molding into pre-formed channels. This NiTi structure provides enhanced, consistent resilience and shape retention for the anterior-posterior wall separation, especially under prolonged suction or repeated autoclaving cycles. The NiTi alloy can undergo a phase transformation at physiological temperatures, allowing for pre-shaping that becomes rigid in situ, or for easier insertion/removal when chilled. The mouth prop similarly uses a higher shore hardness TPE (e.g., 60-70A) for improved bite resistance, with the suction connector still passing through.

Mermaid.js Diagram:

classDiagram
    class Mouthpiece {
        +MainBody(TPE)
        +CheekRetractor(TPE)
        +SuctionConnector(TPE)
        +MouthProp(TPE_hard)
    }
    class BridgeStructure {
        +Material(NiTi_SMA)
        +WaveShape()
        +Protrusions()
    }
    Mouthpiece --* BridgeStructure : embeds/integrates

Derivative 1.2: Mouthpiece with Integrated Piezoelectric Flow Sensors and Micro-Valving Suction Connector

Enabling Description: This variation utilizes a medical-grade liquid silicone rubber (LSR) for the entire mouthpiece, offering superior translucency and heat resistance. The suction connector cavity incorporates miniature, disposable piezoelectric flow sensors (e.g., based on lead zirconate titanate (PZT) ceramic films) embedded within the silicone wall during molding. These sensors generate a voltage proportional to the fluid flow rate through the cavity, providing real-time suction efficacy monitoring. The suction port opening of the connector is equipped with a passive micro-valving system, such as a duckbill valve or a flap valve made from a more rigid, yet flexible, silicone or a compliant polymer (e.g., polyether block amide, PEBA). This micro-valving system prevents backflow of oral fluids into the suction line upon vacuum cessation and allows for variable suction resistance based on flow dynamics, reducing soft tissue impingement. The mouth prop remains a separate, interchangeable component of a similar LSR material, designed for easy snap-on/off attachment to the suction connector, replacing the pass-through design with a side-mounted connection.

Mermaid.js Diagram:

graph TD
    A[Mouthpiece Main Body (LSR)] --> B(Suction Connector (LSR))
    B --> C{Cavity with Piezoelectric Flow Sensor}
    C --> D[Micro-Valving System (PEBA/LSR)]
    D --> E(External Suction Source)
    B -- side-attachment --> F[Mouth Prop (LSR)]

Derivative 1.3: Disposable Biodegradable Mouthpiece with Cellulose Acetate Bridge and Bio-Derived Polymer Body

Enabling Description: Designed for single-use applications requiring stringent infection control and environmental consciousness, this derivative manufactures the main body, cheek retractor, and suction connector from a flexible, bio-derived, biodegradable polymer, such as polylactic acid (PLA) compounded with a plasticizer (e.g., tributyl citrate) to achieve desired flexibility (e.g., tensile modulus of 50-100 MPa). The internal bridge structure, while still wave-shaped and integral, is reinforced with a more rigid, perforated cellulose acetate sheet co-molded within the PLA walls, ensuring separation under suction. The perforations in the cellulose acetate allow for material integration and fluid passage. The mouth prop is also made from a higher-density biodegradable polymer (e.g., PHA - polyhydroxyalkanoate) to withstand bite forces, with a tongue-depressor extension. The entire device is designed for rapid sterilization via gamma irradiation and subsequent decomposition in industrial composting facilities.

Mermaid.js Diagram:

flowchart TD
    A[Biodegradable Mouthpiece Assembly] --> B(Main Body: Flexible PLA)
    B --> C(Suction Connector: Flexible PLA)
    B --> D(Cheek Retractor: Flexible PLA)
    B -- integrates --> E[Bridge Structure: Perforated Cellulose Acetate within PLA]
    A --> F(Mouth Prop: High-Density PHA)
    F -- attaches_to --> C

2. Operational Parameter Expansion

Derivative 2.1: Micro-Scale Intraoral Suction Device for Pediatric and Specialized Veterinary Applications

Enabling Description: This derivative scales down the intraoral device for use in pediatric dentistry, neonatology, or specialized veterinary oral surgery (e.g., small mammals, birds). The overall dimensions are reduced by a factor of 5-10 compared to the adult human version, resulting in a main body length of 10-15 mm and a suction connector diameter of 1-2 mm. The material is an ultra-soft, low-durometer (10-20A Shore A) medical-grade silicone to minimize trauma to delicate tissues. The bridge structure's wave pattern is miniaturized proportionally, maintaining its function of preventing wall collapse under vacuum. The suction connector is designed to interface with micro-aspiration systems capable of generating precisely controlled, low-flow vacuum (e.g., 0.1-1.0 L/min) to prevent tissue aspiration in small subjects. A corresponding miniature mouth prop ensures adequate oral access without overextension. Fabrication requires micro-injection molding techniques for high precision.

Mermaid.js Diagram:

stateDiagram-v2
    state Mouthpiece_Micro {
        [*] --> MainBody_Scaled
        MainBody_Scaled --> BridgeStructure_Miniaturized
        BridgeStructure_Miniaturized --> SuctionConnector_Micro
        SuctionConnector_Micro --> ExternalMicroVacuum
        SuctionConnector_Micro --> MouthProp_Small
    }

Derivative 2.2: Extreme-Temperature Autoclavable Mouthpiece for High-Throughput Sterilization

Enabling Description: This device is engineered for rapid, high-temperature sterilization cycles (e.g., 140°C-150°C at 2-3 bar pressure) common in high-throughput dental clinics or hospital settings, exceeding typical autoclave parameters. The mouthpiece is constructed from a specialized, ultra-high heat-resistant fluorosilicone rubber or a liquid crystal polymer (LCP) reinforced silicone composite, capable of maintaining mechanical integrity and flexibility up to 180°C without degradation, embrittlement, or leaching. The bridge structure's material composition is optimized for dimensional stability at these temperatures, potentially using a ceramic-filled silicone or a PEEK-reinforced polymer to prevent deformation. The mouth prop also uses this advanced material. All components are designed with increased wall thickness (e.g., 20-30% thicker than standard silicone) to mitigate stress fatigue from thermal cycling and high pressure, ensuring reusability over hundreds of cycles.

Mermaid.js Diagram:

classDiagram
    class Mouthpiece {
        +Material: Fluorosilicone/LCP_Composite
        +WallThickness: Increased
    }
    class BridgeStructure {
        +Material: Ceramic-filled_Silicone/PEEK_Reinforced
        +DimensionalStability()
    }
    Mouthpiece "1" -- "1" BridgeStructure : incorporates

Derivative 2.3: Pulsatile Suction Mouthpiece with Integrated Fluidic Oscillators

Enabling Description: This derivative enhances debris removal by incorporating fluidic oscillators within the suction connector and main body. Instead of continuous vacuum, the system generates pulsatile suction (e.g., 1-10 Hz frequency, variable duty cycle) by modulating the vacuum flow. This is achieved through a miniature, pneumatically driven diaphragm or piezoelectric pump mechanism integrated into the suction connector's proximal end. This pulsatile action creates micro-cavitation and shear forces at the perforations and slit, more effectively dislodging and entraining stubborn debris, biofilms, and viscous fluids from the oral cavity. The bridge structure is designed with slightly larger troughs and more compliant crests to better accommodate the dynamic pressure changes without collapsing or losing separation function. The mouth prop is ergonomically designed to absorb any minor vibrations transmitted.

Mermaid.js Diagram:

sequenceDiagram
    patient->>mouthpiece: Oral Fluids/Debris
    mouthpiece->>SuctionConnector: Transport through Perforations/Slit
    SuctionConnector->>FluidicOscillator: Inlet Flow
    FluidicOscillator->>SuctionPort: Pulsatile Output
    SuctionPort->>ExternalVacuum: Extraction

3. Cross-Domain Application

Derivative 3.1: Intraoral Sample Collection Device for Livestock and Wildlife Research (AgTech/Veterinary)

Enabling Description: Adapting the core design, this device is scaled and shaped for the oral anatomy of specific livestock (e.g., cattle, swine) or wildlife species, serving as a hands-free saliva and oral microbiome sample collection tool. The main body is designed to fit the animal's buccal cavity, made from a robust, tear-resistant, food-grade silicone (e.g., platinum-cured, FDA-approved). The bridge structure maintains the separation of walls, while the internal cavity and suction connector are optimized for collecting large volumes of viscous saliva into an attached sterile collection vial rather than simply evacuating. The mouth prop is integrated as a heavy-duty bite block, capable of withstanding significant bite forces from large animals. The suction connector includes a quick-disconnect fitting compatible with standardized animal science sampling equipment. Perforations are sized to prevent tissue aspiration while allowing efficient fluid collection.

Mermaid.js Diagram:

graph LR
    A[Animal Mouthpiece (Scaled Silicone)] --> B(Main Body for Animal Anatomy)
    B --> C(Bridge Structure for Viscous Fluid Flow)
    C --> D(Suction Connector with Quick-Disconnect)
    D --> E[Sterile Sample Vial]
    A --> F[Heavy-Duty Animal Bite Block]

Derivative 3.2: Confined Space Bioreactor/Micro-Environment Control Unit (Aerospace/Biomedical Research)

Enabling Description: This derivative transforms the intraoral device into a miniature, implantable or attachable bioreactor chamber for creating a controlled micro-environment for cellular growth or drug delivery in highly confined or isolated spaces, such as space habitats or specialized lab setups. The main body's pocket becomes a sealed chamber for cell culture or pharmaceutical agents. The 'suction connector' is re-purposed as a fluidic manifold, providing precise ingress and egress of nutrients, waste, and active compounds, potentially with micro-peristaltic pumps. The 'bridge structure' acts as a scaffold for cell adhesion or a diffusion barrier, ensuring even fluid distribution and maintaining chamber integrity. The 'mouth prop' elements are repurposed as anchoring points for secure attachment to a biological surface or mechanical substrate. Materials would be biocompatible, radiation-resistant polymers (e.g., medical-grade PEEK or certain polyurethanes).

Mermaid.js Diagram:

classDiagram
    class ConfinedBioreactor {
        +MainBody_SealedChamber(PEEK)
        +FluidicManifold(PEEK)
        +AnchoringPoints()
    }
    class Scaffold_DiffusionBarrier {
        +BridgeStructure_Repurposed()
        +CellAdhesionSurface()
    }
    ConfinedBioreactor "1" -- "1" Scaffold_DiffusionBarrier : integrates

Derivative 3.3: Automated Oral Hygiene and Oral Care Dispenser (Consumer Electronics/Personal Care)

Enabling Description: This device functions as an automated intraoral cleaning and care system for personal home use, combining elements of tooth brushing, rinsing, and vacuum aspiration. The main body contours to the dental arches, integrating soft silicone bristles (e.g., 0.1-0.2 mm diameter, 5-10 mm length) along its internal surfaces for mechanical plaque removal, possibly with micro-vibration. The suction connector becomes a dual-lumen conduit: one lumen for aspiration of spent rinse/debris, and a second for controlled delivery of oral care solutions (e.g., mouthwash, fluoride, therapeutic gels) via integrated micro-nozzles. The bridge structure ensures efficient distribution of the dispensed solution and subsequent collection by maintaining an open channel. The mouth prop acts as a comfortable bite guide and an external handle for positioning. A small, rechargeable battery and peristaltic pump system are housed externally, connecting via a flexible tube.

Mermaid.js Diagram:

graph TD
    A[Automated Oral Care Device] --> B(Main Body with Bristles)
    B --> C(Dual-Lumen Suction Connector)
    C -- Fluid_Delivery --> D[Oral Care Solution Reservoir]
    C -- Suction --> E(Micro-Peristaltic Pump & Waste Reservoir)
    B -- ensures_flow --> F(Bridge Structure)
    A --> G(Bite Guide/Handle)

4. Integration with Emerging Tech

Derivative 4.1: AI-Optimized Adaptive Suction and Bite Force Mouthpiece with IoT Sensors

Enabling Description: This mouthpiece integrates a suite of IoT sensors (e.g., miniaturized pressure transducers in the mouth prop, pH sensors and temperature sensors on the main body, and fluid flow sensors in the suction connector) that communicate wirelessly (e.g., Bluetooth Low Energy) with an external AI-driven control unit. The AI analyzes real-time data from these sensors (e.g., patient bite force, oral fluid pH, temperature, and suction flow rate) and dynamically adjusts suction pressure via a variable-speed vacuum pump, and potentially provides feedback for optimal mouth prop positioning. For example, if pH drops below a threshold (indicating high acidity), the system might increase rinse flow (if available) or suction. The AI can learn patient-specific comfort thresholds and procedural requirements to optimize suction and isolation, minimizing discomfort and maximizing efficiency. The bridge structure is designed to be highly sensitive to pressure differences to facilitate accurate sensor readings related to wall collapse.

Mermaid.js Diagram:

graph TD
    A[Patient Oral Cavity] --> B(Mouthpiece w/ IoT Sensors)
    B -- Wireless_Data(pH, Temp, Pressure, Flow) --> C(AI Control Unit)
    C -- Control_Signals --> D(Variable-Speed Vacuum Pump)
    D --> E(Suction Connector)
    C -- Feedback --> F(Operator Display)

Derivative 4.2: Blockchain-Enabled Supply Chain & Sterilization Traceability Mouthpiece

Enabling Description: This derivative focuses on integrating supply chain and sterilization data directly with the physical device using blockchain technology. Each reusable mouthpiece and detachable mouth prop is embedded with a unique, serialized Near Field Communication (NFC) or RFID chip (e.g., compliant with ISO/IEC 14443 or ISO/IEC 18000-6C). This chip stores an immutable digital twin of the device on a private blockchain. At each stage of its lifecycle (manufacturing, sterilization, distribution, clinical use, and eventual disposal), key data points (e.g., manufacturing batch, sterilization date/parameters, number of autoclave cycles, patient use log) are recorded and timestamped on the blockchain via a secure reader. This provides verifiable provenance, ensures compliance with sterilization protocols, prevents counterfeit devices, and offers full traceability for quality control and recall purposes. The mouthpiece material (e.g., robust, RFID-compatible silicone) and bridge structure are designed to not interfere with the embedded chip's functionality.

Mermaid.js Diagram:

sequenceDiagram
    participant M as Manufacturer
    participant S as SterilizationFacility
    participant D as Distributor
    participant C as DentalClinic
    participant B as Blockchain
    M->>B: Register Unique Device (Serial #, Mfg Date)
    M->>D: Ship Device
    D->>C: Distribute Device
    C->>S: Send for Sterilization
    S->>B: Record Sterilization Event (Date, Parameters, Cycle Count)
    S->>C: Return Sterile Device
    C->>B: Record Patient Use (Optional)
    C->>C: Device Use Cycle (Monitor RFID/NFC)
    C->>M: Disposal/Recycle (Record on Blockchain)

5. The "Inverse" or Failure Mode

Derivative 5.1: Low-Power/Passive Drainage Mouthpiece with Integrated Over-Pressure Relief

Enabling Description: This mouthpiece is designed for scenarios where continuous high-volume suction is not required, or as a failsafe during power outages. The suction connector incorporates a normally-open, spring-loaded over-pressure relief valve (e.g., set to open at -5 kPa relative to ambient pressure). In normal operation, this valve is closed by active vacuum. If the external vacuum source fails or is intentionally run in a "low-power" mode (e.g., passive gravity drainage or very low-flow battery-operated pump), the valve opens, preventing excessive negative pressure buildup in the oral cavity and allowing ambient air ingress to facilitate passive fluid egress. The main body's internal bridge structure is optimized with larger channels/troughs to maximize fluid flow in low-vacuum or passive drainage modes. The mouth prop's material has a high coefficient of friction to ensure stable positioning without active suction.

Mermaid.js Diagram:

flowchart TD
    A[Mouthpiece Main Body] --> B(Suction Connector)
    B -- includes --> C{Over-Pressure Relief Valve}
    B -- connects_to --> D(External Vacuum Source)
    D -- Fails/LowPower --> C
    C -- Open --> E(Ambient Air Ingress/Passive Drain)
    A -- optimized_for --> F(Large Bridge Channels)

Derivative 5.2: Safely Disengaging Mouth Prop with Shear-Release Mechanism

Enabling Description: This derivative focuses on a safety feature for the mouth prop. The mouth prop, while robust for biting, integrates a shear-release mechanism in its attachment to the suction connector. This mechanism consists of a frangible pin or a calibrated frictional interface designed to detach the mouth prop from the mouthpiece if an excessive, sudden, or abnormal bite force is applied (e.g., >200 N, typical for clenching/spasm) or if the mouthpiece is pulled aggressively by the patient. This prevents potential injury to the patient's temporomandibular joint (TMJ) or damage to the dental work in progress. The mouth prop itself would be made of a slightly softer durometer silicone at the bite surfaces to absorb shock. The suction connector maintains its integrity, ensuring continued fluid evacuation even if the prop detaches.

Mermaid.js Diagram:

graph TD
    A[Patient Bites] --> B(Mouth Prop)
    B -- Transmits_Force --> C{Shear-Release Mechanism}
    C -- If_Force > Threshold --> D(Mouth Prop Detaches Safely)
    C -- If_Force < Threshold --> E(Mouth Prop Remains Attached)
    E --> F(Suction Connector Continues Function)

Combination Prior Art Scenarios

These scenarios combine elements of US11589970 (as generically described or with derivatives) with existing open-source standards to demonstrate further prior art.

Mouthpiece with Integrated pH and Temperature Sensors (from Derivative 4.1) combined with HL7 (Health Level Seven International) Fast Healthcare Interoperability Resources (FHIR) Standard:
- Description: An intraoral device, similar to US11589970, augmented with embedded pH and temperature sensors within its main body (e.g., at the posterior wall near the bridge structure and at the suction inlet). The data collected from these sensors is digitally transmitted (e.g., via Bluetooth LE or NFC) to a local gateway. This gateway then formats the sensor data according to the HL7 FHIR standard for real-time integration into the patient's Electronic Health Record (EHR) system. This allows for automated, hands-free monitoring of oral cavity conditions during prolonged dental procedures, enhancing diagnostic and treatment protocols. The FHIR resources for "Observation" or "DeviceMetric" would be utilized to store and exchange the pH and temperature readings, along with timestamps and device identifiers.
Modular Mouthpiece System with Standardized Attachment Interfaces and STEP (ISO 10303) Format for CAD Models:
- Description: The intraoral device of US11589970, particularly its modularity allowing for different sized mouth props, can be extended to a system where the main body, suction connector, and mouth prop are separate, interchangeable components with standardized mechanical interfaces (e.g., a universal dovetail or bayonet coupling for the mouth prop, and a conical luer lock for the suction line attachment). The CAD models for these standardized interfaces, along with various sizes and configurations of each component (e.g., pediatric, adult small, medium, large mouth props; different cheek retractor shapes), are made publicly available in the ISO 10303 (STEP) file format. This enables third-party manufacturers and dental labs to design and produce compatible, customized, or specialized accessories that can be seamlessly integrated with the core mouthpiece components, fostering an open ecosystem for dental isolation devices.
Autoclavable Mouthpiece (as per US11589970, general) manufactured under an ISO 13485 (Medical devices – Quality management systems – Requirements for regulatory purposes) Certified Process:
- Description: The manufacturing process for the reusable, autoclavable silicone-based intraoral device (main body, bridge, suction connector, mouth prop) described in US11589970 is executed under a Quality Management System that is certified to ISO 13485 standards. This includes adherence to documented procedures for material selection (e.g., medical-grade silicone), injection molding, quality control inspections (e.g., dimensional accuracy, absence of defects, integrity of perforations and bridge structure), traceability of raw materials and finished products, and validation of the sterilization process (e.g., resistance to steam sterilization at 134°C for 18 minutes, as per ISO 17665). This combination makes explicit the integration of a well-known industry standard for medical device quality management with the invention, asserting the obvious need for such robust quality controls in manufacturing for any reusable medical device of this nature.