Knowledge-Based Thrombectomy System with Optical Measurement

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Solution Overview

Problem

Current thrombectomy systems face challenges in accurately determining the proximity of a thrombus, quantifying the amount of thrombus aspirated, randomly determining effective techniques, and lacking standardization, leading to inefficiencies and potential blood loss and vascular injury.

Innovation Solution

A thrombectomy system that utilizes real-time, quantitative viscometric measurements to adjust system parameters and execute deterministic events, allowing for precise measurement of thrombus in the aspirate and optimization of thrombectomy operating modes, thereby minimizing blood loss and standardizing procedures across different facilities and clinicians.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Device complexity

If pressure transducer data is used to infer flow rate and determine catheter status, then system complexity is reduced, but measurement precision deteriorates leading to inaccurate thrombus detection

Engineering Contradiction:
Improvesystem complexityVSAvoidthrombus detection accuracy
Core Design Contradiction:
Device complexityVSMeasurement precision

Solution Approach 1:

The patent replaces pressure-based mechanical measurement with optical measurement. Specifically, it uses light transmission through the catheter to directly measure thrombus presence, substituting the indirect pressure inference method with a direct optical detection method that provides accurate measurement without complex pressure analysis systems

Inventive Principle:
Principle #28Mechanics substitution (Replace mechanical system)

Solution Approach 2:

The patent introduces light as an intermediary medium to detect thrombus. By measuring light transmission through the catheter, the system uses light as a mediator between the thrombus and the detector, enabling direct observation of thrombus properties without relying on pressure transducers or complex inference algorithms

Inventive Principle:
Principle #24Intermediary (Mediator)

2Measurement precision

If manual clinician intervention is used to clear clogged catheters, then measurement precision is maintained through direct observation, but loss of time increases and productivity decreases

Engineering Contradiction:
Improvecatheter status monitoring accuracyVSAvoidprocedure efficiency
Core Design Contradiction:
Measurement precisionVSProductivity

Solution Approach 1:

The patent implements continuous real-time feedback by monitoring light transmission through the catheter throughout the procedure. This allows the system to automatically detect when thrombus is present or when the catheter becomes clogged, providing continuous information without requiring manual intervention or stopping the procedure for assessment

Inventive Principle:
Principle #23Feedback

Solution Approach 2:

The patent enables the system to self-monitor and self-diagnose catheter status automatically. The light transmission measurement system continuously assesses catheter conditions without requiring clinician intervention, allowing the system to identify problems and alert operators in real-time, maintaining productivity while ensuring accurate monitoring

Inventive Principle:
Principle #25Self-service

3Productivity

If hemolytic agents are used to decompose thrombus, then productivity increases by chemical decomposition, but object-generated harmful factors worsen due to systemic hemolysis of viable blood and vascular tissue

Engineering Contradiction:
Improvethrombus decomposition rateVSAvoidsystemic hemolysis and tissue decomposition
Core Design Contradiction:
ProductivityVSObject-generated harmful factors

Solution Approach 1:

The patent extracts and removes thrombus mechanically through the catheter before it can cause systemic harm. By physically aspirating and removing the thrombus intact through the catheter, the system prevents the thrombus from entering the systemic circulation and causing harmful effects, while still achieving efficient thrombus removal

Inventive Principle:
Principle #2Taking out (Extraction)

Solution Approach 2:

The patent converts the potential harm of thrombus embolization into a benefit by using the catheter to capture and remove the thrombus. The same catheter that could potentially allow thrombus to enter circulation is instead used to extract and remove it, transforming a potential harmful pathway into a beneficial removal mechanism

Inventive Principle:
Principle #22Blessing in disguise (Convert harm into benefit)

Applied Scientific Principles

This section explains which scientific principles are used to turn an abstract innovation direction into a practical engineering solution.

Function Achieved in This Case

The system enables efficient and standardized thrombectomy procedures by quantitatively measuring thrombus in the aspirate, optimizing system parameters, and reducing blood loss and vascular injury, allowing novice clinicians to achieve results comparable to experienced professionals.

Implementation Method 1

viscometric measurement data obtained by the system

Methodology Applied
Scientific EffectViscometry: Viscometer

Implementation Method 2

hydrodynamic (or rheolytic) effects, where liquid is infused into the catheter; this liquid may be delivered at high pressures (e.g., up to approximately 10,000 psi, 666 bar) such that a high velocity liquid jet performs maceration of thrombus

Methodology Applied
Scientific EffectHydrodynamic effect: Jet Erosion

Implementation Method 3

Other thrombectomy systems employ manually manipulated obturators and/or rotating cutters to mechanically macerate thrombus

Methodology Applied
Scientific EffectOscillatory flow: Vibration

Data Source

PatentUS20240130747A1Knowledge-Based Thrombectomy System
Publication Date: 2024.04.25 SHIFFLETTE J MICHAEL
  • US20240130747A1 patent drawing
  • US20240130747A1 patent drawing
  • US20240130747A1 patent drawing

AI summary

Thrombectomy systems are disclosed that utilize a knowledge base comprising intra-procedural and inter-procedural (i.e., historical) measurement data that is correlated to deterministic events that predicate each measurement. Each thrombectomy procedure is thereby a compendium of cause and effect experimentation; experimental data are retained, in addition to being utilized intra-procedurally to determine future experimental configurations (deterministic events). Herein, experimental data comprise variable measurement data of intensive physical properties of the aspirate within the catheter (e.g., viscosity=10 cP, % thrombus=15%, thrombus load=25%, etc.). Knowledge-based thrombectomy systems engender procedure standardization across multiple thrombectomy systems, facilities and clinicians by standardizing the sequence of intra-procedural, deterministic events. Some embodiments feature a plurality of subsystems (experimental factors) such as Liquid Column Oscillator, Harmonic Oscillator, frequency, aspiration rate, infusion rate, mechanical or hydrodynamic lance, catheter position and/or configuration, etc.; these subsystems being operable at a plurality of setpoints (experimental levels). A knowledge base is compiled that identifies and exploits efficacious experimental configurations and abandons or modifies inefficacious experimental configurations.