Vein Compliance Assessment Device for Stent Placement

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Solution Overview

Problem

Current iliac vein stenting techniques face challenges such as stent compression, migration, and recoil due to anatomical variability and poor diagnostic methods, leading to unpredictable stent placement and high reintervention rates, especially at the iliac-caval junction.

Innovation Solution

A device with an elongated body and a balloon capable of inflation, equipped with excitation and detection electrodes, pressure sensors, and a suction/infusion port, which generates conductance measurements to assess cross-sectional areas and compliance, allowing for precise stent placement and selection based on individual vein anatomy.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Manufacturing precision

If stent is placed precisely at the iliac-caval junction to avoid encroachment, then vena cava integrity is preserved, but stent compression and migration occur due to anatomical variability and lesion recoil

Engineering Contradiction:

Improvestent placement precisionVSAvoidstent stability

Core Design Contradiction:

Manufacturing precisionVSReliability

Solution Approach 1:

The system performs preliminary assessment of vein compliance and geometric profiles before stent placement. By measuring compliance at different locations and predicting recoil behavior in advance, the system enables selection of optimal stent characteristics and placement strategy, preventing compression and migration before they occur

Inventive Principle:

Principle #10Preliminary action

Solution Approach 2:

The system provides real-time feedback on vein compliance and geometric characteristics during the procedure. This feedback loop allows adjustment of stent selection and placement parameters based on actual measured properties, ensuring both precise placement and long-term stability

Inventive Principle:

Principle #23Feedback

2Loss of information

If venography is used to visualize vein anatomy, then anatomical structure is visible, but compliance assessment and lumen profile accuracy are insufficient

Engineering Contradiction:

Improveanatomical information completenessVSAvoidcompliance measurement accuracy

Core Design Contradiction:

Loss of informationVSMeasurement precision

Solution Approach 1:

The system replaces the mechanical/visual assessment method (venography) with an electrical measurement approach. By using conductance measurements and applying electrical fields, the system quantitatively assesses compliance and lumen profile, providing both anatomical visualization and functional measurement simultaneously

Inventive Principle:

Principle #28Mechanics substitution (Replace mechanical system)

Solution Approach 2:

The system combines multiple functions into a single assessment tool. It simultaneously provides anatomical visualization, compliance measurement, lumen profile assessment, and recoil prediction, replacing the need for separate venography and compliance assessment procedures

Inventive Principle:

Principle #6Universality (Multi-functionality)

3Measurement precision

If IVUS is used to assess geometric complexities, then local geometric accuracy is improved, but compliance assessment under radial force conditions and cost-effectiveness are compromised

Engineering Contradiction:

Improvegeometric measurement accuracyVSAvoidassessment system complexity

Core Design Contradiction:

Measurement precisionVSDevice complexity

Solution Approach 1:

The system replaces the complex mechanical ultrasound imaging system with a simpler electrical conductance measurement system. By measuring electrical properties and using computational models, it achieves both geometric assessment and compliance measurement under radial force conditions without the complexity and cost of IVUS

Inventive Principle:

Principle #28Mechanics substitution (Replace mechanical system)

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

Enables accurate assessment of vein compliance and cross-sectional areas, facilitating precise stent placement, reducing migration and recoil, and improving the effectiveness of iliac vein stenting by providing real-time data for optimal stent deployment.

Implementation Method 1

at least two excitation electrodes generate an electric field

Methodology Applied

Scientific EffectElectric field: Electric Field

Implementation Method 2

at least two of the at least three detection electrodes can detect the electric field and obtain at least one conductance measurement within the balloon

Methodology Applied

Scientific EffectElectrical conduction: Conduction (electrical)

Data Source

PatentUS11219388B2Devices, systems, and methods for determining vein geometric and compliance profiles for venous stenting

Publication Date: 2022.01.11 3DT HLDG

AI summary

Devices, systems, and methods for determining vein geometric and compliance profiles for venous stenting. In one device embodiment, the device comprises an elongated body configured to fit within a mammalian luminal organ, a balloon coupled to the elongated body capable of and configured for inflation and deflation within the mammalian luminal organ, at least two excitation electrodes positioned along the elongated body within the balloon, and a plurality of at least three detection electrodes positioned in between at least two of the at least two excitation electrodes, wherein a first pair of two adjacent detection electrodes of the at least three detection electrodes can detect an electric field generated by the at least two excitation electrodes and obtain a first conductance measurement within the balloon, and a second pair of two adjacent detection electrodes can detect the electric field and obtain a second conductance measurement within the balloon.