Derivative works — US Patent 12016580

Defensive Disclosure: Derivatives of US12016580 - Single Insertion Delivery System

This document outlines derivative works and technical disclosures related to US Patent 12016580, "Single insertion delivery system for treating embolism and associated systems and methods," for defensive publishing purposes. The aim is to establish prior art that could render future incremental improvements by competitors as obvious or non-novel.

The derivations are based on the independent claims of US12016580, specifically focusing on the system claim (Claim 18) due to its comprehensive description of the invention's components and functionality, which inherently covers the method claims (Claims 1 and 11).

Derivatives of Independent Claim 18 (System)

Claim 18 Summary: A system for treating clot material, including a guide catheter, delivery sheath, interventional device, retraction and aspiration (RA) device, and an attachment member coupled to the guide catheter. The attachment member is actuatable between sealed and unsealed configurations, where the unsealed configuration provides a continuous, consistent-diameter lumen for interventional device passage without stripping clot. The RA device simultaneously retracts the delivery sheath/interventional device and aspirates through the guide catheter.

1. Material & Component Substitution

Derivative 1.1: Shape Memory Alloy Actuation for Attachment Member

Enabling Description: The attachment member (AM) housing (1370) integrates a shape memory alloy (SMA) element, such as a Nitinol coil, within or around the tubular member (1372). Instead of mechanical buttons (1378) or filaments (1376) for actuation, localized resistive heating is applied to the SMA element (e.g., via embedded micro-heaters and electrical contacts) to transition it from a martensitic (sealed/collapsed) to an austenitic (unsealed/expanded) phase. Upon cooling (e.g., active cooling via fluid circulation or passive heat dissipation), the SMA returns to its martensitic phase, sealing the lumen. The tubular member (1372) is fabricated from a medical-grade, low-friction, high-elasticity polymer, such as a silicone-polyurethane copolymer, capable of accommodating the SMA-induced diameter changes. The RA device (100) includes a control module that sends precise electrical pulses to activate the SMA, allowing for controlled, gradual opening and closing of the AM lumen. This eliminates mechanical linkages prone to wear and offers fine control over lumen diameter.
```
classDiagram
    class System {
        +GuideCatheter GC
        +DeliverySheath DS
        +InterventionalDevice ID
        +RA_Device RAD
        +AttachmentMember AM
    }
    class AttachmentMember {
        +Housing 1370
        +TubularMember 1372
        +SMA_Actuator SMA
        +MicroHeaters MH
        +ControlModule CM
    }
    class SMA_Actuator {
        +NitinolCoil
        +MartensiticPhase()
        +AusteniticPhase()
    }
    class ControlModule {
        +SendElectricalPulses(target_temp)
        +MonitorTemperature(sensor_data)
    }
    System "1" -- "1" AttachmentMember : includes
    AttachmentMember "1" -- "1" SMA_Actuator : actuates
    AttachmentMember "1" -- "1" ControlModule : controls
    ControlModule -- MicroHeaters : powers
```

Derivative 1.2: Magnetorheological Fluid Seal for Attachment Member

Enabling Description: The attachment member (AM) utilizes a magnetorheological (MR) fluid as the sealing mechanism. The tubular member (1372) is replaced with a compliant elastomer membrane (e.g., medical-grade silicone) defining the central lumen (1374). The space between this membrane and the outer housing (1370) is filled with an MR fluid. A series of electromagnets are embedded within the housing (1370) surrounding the MR fluid chamber. To seal, a magnetic field is applied, causing the MR fluid's ferromagnetic particles to align and rapidly increase the fluid's apparent viscosity and yield strength, effectively solidifying around the interventional device (ID) or guidewire. To unseal, the magnetic field is removed, and the fluid returns to a low-viscosity state, allowing the elastomer membrane to expand to its maximum diameter (1371). The RA device (100) incorporates a power supply and control unit for the electromagnets, allowing variable sealing pressure.
```
flowchart TD
    A[Attachment Member] --> B{MR Fluid Chamber}
    B --> C[Elastomer Membrane (Lumen)]
    B --> D[Electromagnets]
    D -- On --> E{MR Fluid Solidifies}
    E --> F[Sealed Configuration]
    D -- Off --> G{MR Fluid Fluidizes}
    G --> H[Unsealed Configuration]
    F -- Interventional Device Passage --> I(Hemostasis Maintained)
    H -- Interventional Device Passage --> J(Unrestricted Passage)
```

Derivative 1.3: Piezoelectric-Actuated Fiber Optic Sensing for Interventional Device Deployment

Enabling Description: The delivery sheath (204) and interventional device (ID) incorporate embedded piezoelectric micro-actuators and fiber optic sensors. The piezoelectric elements, distributed along the distal end of the delivery sheath, can generate precise, localized vibrations to help dislodge and capture clot material upon deployment. The fiber optic sensors, such as Fiber Bragg Gratings (FBGs), are embedded along the ID and delivery sheath to provide real-time, high-resolution feedback on deformation, temperature, and contact pressure during deployment and retraction. This data is transmitted to an integrated processing unit within the RA device (100). This unit uses these inputs to adjust the retraction speed, aspiration pressure, and even the vibrational frequency of the piezoelectric elements, optimizing clot capture and minimizing vessel trauma. The attachment member maintains its primary sealing function but now receives fine-tuned operational parameters from the RA device based on this advanced sensing.
```
sequenceDiagram
    Operator->>RA_Device: Initiate Deployment
    RA_Device->>Delivery_Sheath: Advance DS
    RA_Device->>Interventional_Device: Deploy ID
    Interventional_Device->>+Fiber_Optic_Sensors: Sense (Deformation, Pressure, Temp)
    Fiber_Optic_Sensors->>RA_Device: Send FBG Data (Real-time)
    Interventional_Device->>+Piezo_Actuators: Apply Micro-Vibrations (Optional)
    Piezo_Actuators->>RA_Device: Send Feedback
    RA_Device->>RA_Control_Unit: Process Sensor Data
    RA_Control_Unit->>RA_Device: Adjust Retraction Speed, Aspiration Pressure, Vibration Freq.
    RA_Device->>Attachment_Member: Adjust Sealing/Unsealing Parameters (Optional)
    Note over RA_Control_Unit: AI-driven optimization
```

2. Operational Parameter Expansion

Derivative 2.1: Micro-Thrombectomy System for Capillary-Level Occlusions

Enabling Description: This derivative scales the system down for micro-thrombectomy in cerebral microvasculature or retinal arteries, targeting emboli smaller than 100 micrometers. The guide catheter (206) becomes a micro-catheter with an outer diameter of 0.5-1.0 mm. The delivery sheath (204) and interventional device (ID) are scaled to 100-300 micrometers. The ID utilizes a chemically functionalized surface (e.g., streptokinase- or urokinase-impregnated polymers) for localized thrombolysis, combined with a photo-activated polymeric mesh for clot capture. The RA device (100) generates ultra-low, precisely controlled negative pressures (e.g., 0-5 mmHg) via a peristaltic pump system to avoid vessel collapse in delicate microvessels. The attachment member (1108) is a miniature garrote valve, actuated by micro-solenoids, providing a hermetic seal around the micro-catheter elements while ensuring a constant micro-lumen diameter for atraumatic device withdrawal. Optical coherence tomography (OCT) or two-photon microscopy are integrated for visualization.
```
classDiagram
    class MicroThrombectomySystem {
        +MicroCatheter MC
        +MicroDeliverySheath MDS
        +MicroInterventionalDevice MID
        +MicroRA_Device MRAD
        +MicroAttachmentMember MAM
    }
    class MicroCatheter {
        +OuterDiameter: 0.5-1.0mm
        +Lumen
    }
    class MicroInterventionalDevice {
        +Diameter: 100-300um
        +ChemFunctionalizedSurface: Thrombolytic
        +PhotoActivatedPolymericMesh: Clot Capture
    }
    class MicroRA_Device {
        +PeristalticPump: Ultra-low Pressure Aspiration (0-5 mmHg)
        +ControlUnit
    }
    class MicroAttachmentMember {
        +MiniatureGarroteValve
        +MicroSolenoidActuation
        +HermeticSeal
    }
    MicroThrombectomySystem "1" -- "1" MicroCatheter
    MicroCatheter "1" -- "1" MicroDeliverySheath
    MicroDeliverySheath "1" -- "1" MicroInterventionalDevice
    MicroThrombectomySystem "1" -- "1" MicroRA_Device
    MicroThrombectomySystem "1" -- "1" MicroAttachmentMember
```

Derivative 2.2: High-Flow, Pulsed Aspiration for Large Vessel De-Clotting

Enabling Description: This system is optimized for rapid de-clotting in large vessels, such as the inferior vena cava (IVC) or aorta, handling massive thrombi. The guide catheter (206) has an internal diameter greater than 10 mm. The RA device (100) integrates a high-volume, variable-frequency pulsatile pump capable of generating negative pressures up to 500 mmHg with flow rates exceeding 5 L/min. This pulsatile aspiration creates transient pressure differentials, aiding in fragmenting and dislodging larger, adherent clot material. The interventional device (ID) features a high-tensile strength polymeric or metallic mesh with optimized pore sizes for capturing large clot fragments while minimizing flow obstruction. The attachment member (1108) utilizes a robust, pneumatically actuated garrote valve with a rapid response time (sub-second) to synchronize with the pulsatile aspiration and device retraction, ensuring quick sealing and unsealing to handle high flow volumes without leakage.
```
stateDiagram-v2
    state "RA Device Idle" as RAD_IDLE
    state "Generate Negative Pressure" as ASPIRATING
    state "Retract Device" as RETRACTING
    state "Attachment Member Sealed" as AM_SEALED
    state "Attachment Member Unsealed" as AM_UNSEALED

    RAD_IDLE --> ASPIRATING : Lever Actuated (Pump)
    ASPIRATING --> RETRACTING : Simultaneous Operation
    RETRACTING --> ASPIRATING : Multiple Pumps
    AM_SEALED --> AM_UNSEALED : Actuate AM (Open)
    AM_UNSEALED --> AM_SEALED : Actuate AM (Close)

    ASPIRATING --> AM_SEALED : During Positive Pressure (Backflow Prevention)
    RETRACTING --> AM_UNSEALED : During ID Withdrawal
    AM_UNSEALED --> ASPIRATING : ID Passage with Aspiration
    AM_SEALED --> RAD_IDLE : Procedure Complete
```

3. Cross-Domain Application

Derivative 3.1: Industrial Pipeline De-Clogging System (Oil & Gas)

Enabling Description: The system is adapted for clearing paraffin, asphaltene, or hydrate blockages from industrial pipelines (e.g., oil and gas flowlines). The "guide catheter" becomes a rigid or flexible drilling conduit, advanced from a wellhead or access port. The "interventional device" is a modular drilling/scraping tool (e.g., a rotary cutter, brush, or solvent dispenser) designed to engage and break up blockages. The "delivery sheath" protects the drilling tool during insertion. The "RA device" is a high-pressure pumping and suction unit, circulating hot solvents or dispersants while simultaneously extracting dissolved/fragmented material. The "attachment member" functions as a configurable high-pressure isolation valve or blow-out preventer (BOP) at the wellhead or access point. It features an expandable elastomer seal reinforced with steel segments, capable of sealing around various tool diameters and maintaining pressure integrity during tool exchanges without depressurizing the entire pipeline segment.
```
flowchart LR
    A[Access Port / Wellhead] -- Conduit --> B(Pipeline)
    B -- Blockage --> C(Drilling/Scraping Tool)
    C -- Delivery Sheath --> A
    A -- Configurable Isolation Valve (Attachment Member) --> D[High-Pressure Pump & Suction Unit (RA Device)]
    D -- Circulate Solvents/Dispersants --> B
    D -- Extract Blockage Material --> E(Waste Reservoir)
```

Derivative 3.2: Automated Debris Removal for HVAC Ducts

Enabling Description: This system is used for automated cleaning and debris removal within HVAC ductwork. The "guide catheter" is a deployable conduit, such as a flexible, segmented robotic arm or a track-guided sleeve, that can be navigated through the duct. The "interventional device" is a robotic brush, vacuum nozzle, or laser ablation head, designed to dislodge and remove accumulated dust, mold, or foreign objects. The "delivery sheath" protects the robotic arm/tool during navigation. The "RA device" is a high-power industrial vacuum system, connected to the deployable conduit, providing continuous or pulsed suction for debris collection. The "attachment member" is an access port with an actuated diaphragm seal (e.g., pneumatic or electric motor-driven iris diaphragm) that creates a tight seal around the deployed conduit, preventing contaminant escape and maintaining negative pressure within the duct during cleaning cycles, while allowing seamless tool insertion and withdrawal.
```
graph TD
    A[Access Port] --> B{Attachment Member: Iris Diaphragm Seal}
    B --> C[Deployable Conduit (Guide Catheter)]
    C --> D[HVAC Ductwork]
    C --> E[Robotic Tool (Interventional Device)]
    F[Industrial Vacuum (RA Device)] --> B
    E -- Dislodge Debris --> D
    D -- Suction Debris --> F
```

Derivative 3.3: Micron-Scale Contaminant Extraction in Semiconductor Manufacturing

Enabling Description: This system is for precise, in-situ extraction of micron-scale contaminants (e.g., particles, chemical residues) from intricate fluidic channels or surfaces within semiconductor manufacturing equipment (e.g., lithography systems, wet benches). The "guide catheter" is a rigid or flexible micro-manipulator, potentially incorporating MEMS-actuators for fine positioning, delivering a cleaning fluid or gas. The "interventional device" is a micro-tool such as an acoustic transducer for cavitation, a micro-jet nozzle for localized fluidic scrubbing, or a nano-fiber "brush" for particle capture. The "delivery sheath" protects the micro-tool during insertion. The "RA device" is a precision micro-fluidic control system, providing controlled flow rates of ultra-pure cleaning fluids and high-efficiency micro-aspiration for contaminant removal. The "attachment member" is a specialized, contamination-controlled docking port with a pressure-actuated fluidic seal (e.g., a dynamic liquid O-ring or ferrofluidic seal) that creates a localized, ultra-clean environment around the micro-manipulator, preventing particle ingress/egress while allowing precise micro-tool exchange.
```
flowchart LR
    A[Micro-Manipulator (Guide Catheter)]
    B[Micro-Tool (Interventional Device)]
    C[Micro-Fluidic Control (RA Device)]
    D[Contamination-Controlled Docking Port (Attachment Member)]
    E[Semiconductor Equipment Channel]

    A -- Delivers Cleaning Fluid/Gas --> E
    B -- Engages Contaminants --> E
    C -- Provides Aspiration/Fluid Control --> E
    D -- Seals Around A --> C
    D -- Facilitates B Insertion/Withdrawal --> A
```

4. Integration with Emerging Tech

Derivative 4.1: AI-Driven Optimization with IoT Sensors for Predictive Embolism Treatment

Enabling Description: The system integrates a suite of IoT micro-sensors (pressure, temperature, flow, chemical markers, ultrasound transducers) along the guide catheter (206) and interventional device (ID). These sensors continuously stream real-time physiological and procedural data to an on-board AI diagnostic and control module within the RA device (100). The AI analyzes this data to: (i) predict clot morphology and adherence, optimizing ID deployment angle and retraction force; (ii) dynamically adjust aspiration pressure and duration based on real-time flow and clot fragmentation; (iii) provide real-time feedback on vessel health and potential trauma; and (iv) suggest optimal flushing protocols. The attachment member (1108) incorporates a smart, self-calibrating seal with integrated pressure sensors, allowing the AI to fine-tune its sealing force to the exact interventional device diameter, preventing leaks while minimizing friction.
```
flowchart TD
    A[IoT Micro-Sensors (GC/ID)] --> B{Data Stream}
    B --> C[AI Diagnostic & Control Module (RA Device)]
    C -- Optimize ID Deployment --> D[Interventional Device]
    C -- Adjust Aspiration Parameters --> E[RA Device Aspiration Unit]
    C -- Fine-tune Sealing Force --> F[Smart Attachment Member]
    C -- Provide Real-time Feedback --> G(Operator Interface)
    G --> H(Vessel Health/Trauma Alerts)
```

Derivative 4.2: Blockchain-Enabled Supply Chain & Procedural Logging

Enabling Description: Each major component of the clot retrieval system (guide catheter, delivery sheath, interventional device, RA device, attachment member, and valve inserts) is tagged with a unique, cryptographically secured identifier (e.g., RFID with embedded tamper-proof chips). Upon manufacturing, packaging, sterilization, and distribution, each event is recorded on a private blockchain network accessible by manufacturers, distributors, and healthcare providers. During a medical procedure, the RA device (100) automatically logs the unique identifiers of all connected disposable components. Key procedural steps (e.g., device insertion, AM actuation, aspiration cycles, clot removal events, timestamps) are also recorded on the blockchain, creating an immutable audit trail for regulatory compliance, warranty tracking, and quality assurance. This ensures transparency, verifies component authenticity, and provides a robust, unalterable record of device usage.
```
sequenceDiagram
    Manufacturer->>Blockchain: Register Component ID & Mfg Data
    Distributor->>Blockchain: Log Shipping & Receiving (Component ID)
    Hospital->>Blockchain: Log Receipt & Inventory (Component ID)
    Operator->>RA_Device: Attach Components (GC, DS, ID, AM)
    RA_Device->>RA_Device: Scan Component IDs
    RA_Device->>Blockchain: Log Component Usage (Procedure ID, Timestamp)
    Operator->>RA_Device: Perform Procedure Steps
    RA_Device->>Blockchain: Log Procedure Events (AM Actuation, Aspiration, Clot Removal)
    Blockchain->>Regulatory_Authorities: Provide Immutable Audit Trail
```

5. The "Inverse" or Failure Mode

Derivative 5.1: Bio-Resorbable Interventional Device with Automated Safe Dissolution

Enabling Description: The interventional device (ID) is fabricated from a bio-resorbable polymer (e.g., poly(lactic-co-glycolic acid) (PLGA) or polycaprolactone (PCL)) and designed for controlled degradation. In the event of unsuccessful retrieval or if the ID becomes irretrievably lodged, the RA device (100) can initiate an "automated safe dissolution" protocol. This involves introducing a specific, biocompatible solvent (e.g., a low-pH saline solution or enzymatic agent) through the guide catheter (206) lumen, which is recirculated by the RA device. The solvent accelerates the degradation of the ID into harmless, absorbable monomers, minimizing patient trauma from a permanently implanted or fractured device. The attachment member (1108) provides a robust, leak-proof seal during solvent circulation to prevent systemic exposure, and its internal lumen is constructed from materials resistant to the dissolution agent. The RA device monitors the degradation process via integrated sensors (e.g., pH, conductivity, turbidity).
```
graph LR
    A[Interventional Device (Bio-Resorbable)] -- Lodged / Failure to Retrieve --> B{RA Device: Initiate Dissolution Protocol}
    B --> C[Introduce Biocompatible Solvent (via GC)]
    C --> D[Target ID for Degradation]
    D -- Degradation Monitored by Sensors --> B
    B -- Recirculate Solvent --> C
    D -- ID Dissolves --> E[Harmless Monomers]
    F[Attachment Member] -- Maintains Leak-Proof Seal --> C
```

Derivative 5.2: Limited-Functionality "Patency Maintenance" Mode

Enabling Description: In situations where full clot removal is not immediately possible or desirable (e.g., patient instability, complex clot morphology requiring prolonged intervention), the system can operate in a "patency maintenance" mode. In this mode, the interventional device (ID) (e.g., a temporary expandable mesh or flow diverter) is deployed to create a minimal lumen through the clot, restoring partial blood flow. The RA device (100) reduces aspiration to a minimal, continuous flow rate (e.g., 0.1-0.5 L/min) to maintain patency without actively removing bulk clot, conserving blood and energy. The attachment member (1108) remains in a semi-sealed state, allowing a guidewire to remain in place for future re-intervention, while minimizing blood loss. The system provides continuous monitoring of distal flow and pressure, triggering alerts if patency is compromised, but refrains from full-power retraction/aspiration unless explicitly commanded by the operator.
```
stateDiagram-v2
    state "Full Thrombecomy Mode" as ACTIVE_MODE
    state "Patency Maintenance Mode" as LOW_POWER_MODE

    ACTIVE_MODE --> LOW_POWER_MODE : Operator Command (Patient Instability, etc.)
    LOW_POWER_MODE --> ACTIVE_MODE : Operator Command (Resume Full Removal)

    state "ID Fully Deployed" as ID_DEPLOYED
    state "Minimal Aspiration" as MIN_ASPIRATION
    state "AM Semi-Sealed" as AM_SEMI_SEALED
    state "Continuous Monitoring" as MONITORING

    LOW_POWER_MODE --> ID_DEPLOYED : (Temporary Mesh/Flow Diverter)
    LOW_POWER_MODE --> MIN_ASPIRATION : (0.1-0.5 L/min)
    LOW_POWER_MODE --> AM_SEMI_SEALED : (Guidewire Access)
    LOW_POWER_MODE --> MONITORING : (Distal Flow/Pressure)

    MIN_ASPIRATION --> MONITORING : Provides Data
    AM_SEMI_SEALED --> MONITORING : Provides Data
    MONITORING --> Alert : If Patency Compromised
```

Combination Prior Art Scenarios with Open-Source Standards

These scenarios combine elements of US12016580 with existing open-source standards, demonstrating how such integrations could be considered obvious to a person skilled in the art.

DICOM (Digital Imaging and Communications in Medicine) Integration for Imaging Guidance:
- Scenario: The clot retrieval system (US12016580) is commonly guided by fluoroscopic imaging. Integrating the system with DICOM standards would enable the real-time transmission and archiving of all intraoperative imaging (e.g., angiograms) directly to the hospital's Picture Archiving and Communication System (PACS). This allows for immediate correlation of the interventional device's position relative to the clot material (PE) and guide catheter (206) with pre-operative diagnostic images, improving precision during deployment (block 1001, 1401) and facilitating post-procedure assessment (block 1003, 1403). The RA device (100) or an auxiliary control unit would include a DICOM-compliant interface to receive and transmit image data, overlaying device position on the live fluoroscopic feed.
- Open-Source Standard: DICOM (ISO 12052), a widely adopted standard for handling, storing, printing, and transmitting information in medical imaging.
HL7 (Health Level Seven) for Electronic Health Record (EHR) Integration:
- Scenario: Data generated by the clot retrieval system (US12016580), such as procedure start/end times, aspiration volumes, removed clot characteristics (if measured), device serial numbers, and any alerts from integrated sensors (as in Derivative 4.1), are formatted and transmitted via HL7 messaging standards to the patient's Electronic Health Record (EHR). This automated data capture streamlines documentation, enhances billing accuracy, and supports clinical research by providing a structured, interoperable data set. The RA device (100) or an associated gateway device would incorporate an HL7 interface engine to process and send relevant data to the hospital's EHR system.
- Open-Source Standard: Health Level Seven (HL7), a set of international standards for transfer of clinical and administrative data between healthcare information systems.
ROS (Robot Operating System) for Robotic-Assisted Catheter Navigation and Device Manipulation:
- Scenario: For advanced robotic-assisted interventional procedures, the mechanical retraction and aspiration functions of the RA device (100) and precise movements of the delivery sheath (204) and interventional device (ID) are controlled and coordinated using a Robot Operating System (ROS) framework. ROS nodes would manage individual robotic effectors (e.g., for guide catheter steering, delivery sheath advancement, ID articulation), integrate sensor feedback (e.g., force, torque, position, haptic feedback), and interface with imaging systems. This allows for more sophisticated, automated, or semi-automated navigation to the clot (block 1001, 1401) and precise device manipulation during clot engagement and retraction (block 1002, 1402). The attachment member's (1108) actuation mechanism would also be controlled via ROS, ensuring synchronized opening/closing with robotic tool changes.
- Open-Source Standard: Robot Operating System (ROS), a flexible framework for writing robot software, providing libraries and tools to help software developers create robot applications.