Fiber Optic Sensor Assembly for Vascular Pressure Monitoring

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Solution Overview

Problem

Accurate pressure measurement within vascular structures, such as coronary arteries, is complicated by the small size of these vessels, pulsatile blood flow, and the need to avoid trauma, especially when sclerotic lesions or stents are present, requiring a pressure sensing system that can navigate through narrowed areas and provide reliable data for therapy decisions.

Innovation Solution

A sensor delivery device with a fiber optic pressure sensor assembly that includes a housing and a filler with tapered surfaces to facilitate navigation through narrow vessels, coupled with a guidewire-based delivery system, allowing for accurate pressure measurement upstream and downstream of stenotic lesions, and enabling fractional flow reserve calculations without repositioning.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Object-affected harmful factors

If the sensor is made small and non-toxic to minimize trauma, then patient safety is improved, but the sensor may not be able to transmit data reliably over long distances

Engineering Contradiction:
Improvetrauma to patientVSAvoiddata transmission reliability
Core Design Contradiction:
Object-affected harmful factorsVSReliability

Solution Approach 1:

The patent replaces traditional electrical wiring with optical fiber for data transmission. The optical fiber conducts light signals from the miniaturized sensor through the catheter to external processing equipment, enabling reliable long-distance data transmission from small sensors without electrical interference or signal degradation issues

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

Solution Approach 2:

The patent embeds the optical fiber within the catheter structure, nesting the data transmission medium inside the delivery device. This allows the sensor, optical fiber, and catheter to be integrated into a compact assembly that can navigate vascular structures while maintaining reliable data transmission capabilities

Inventive Principle:
Principle #7Nested doll (Nesting)

2Adaptability or versatility

If the catheter is made flexible to navigate through narrow vessels, then accessibility to target location is improved, but structural stability for accurate measurement may be compromised

Engineering Contradiction:
Improvenavigation through narrow vesselsVSAvoidpressure measurement accuracy
Core Design Contradiction:
Adaptability or versatilityVSMeasurement precision

Solution Approach 1:

The patent employs a flexible catheter construction that can conform to and navigate through narrow and tortuous vascular pathways. The flexible shell design allows the catheter to bend and adapt to vessel geometry while maintaining its structural integrity and the positioning stability needed for accurate pressure measurements at the distal tip

Inventive Principle:
Principle #30Flexible shells and thin films

3Volume of moving object

If the sensor assembly is made compact to fit within the catheter, then deliverability is improved, but the sensor may be more susceptible to damage from pulsatile blood flow

Engineering Contradiction:
Improvesensor assembly sizeVSAvoidsensor durability
Core Design Contradiction:
Volume of moving objectVSStrength

Solution Approach 1:

The patent protects the compact sensor by nesting it within a protective housing that is itself inserted into the catheter lumen. This nested arrangement provides mechanical protection against pulsatile blood flow and vascular trauma while maintaining the compact size needed for delivery through narrow vessels

Inventive Principle:
Principle #7Nested doll (Nesting)

Solution Approach 2:

The patent incorporates a filler material surrounding the sensor and optical fiber within the housing. This filler acts as a cushioning element that absorbs mechanical shocks and stresses from pulsatile blood flow and catheter manipulation, protecting the delicate sensor and optical components before damage can occur

Inventive Principle:
Principle #11Beforehand cushioning (Prior cushioning)

4Reliability

If the optical fiber is routed externally along the catheter, then data transmission is maintained, but the overall device complexity increases

Engineering Contradiction:
Improvedata transmission capabilityVSAvoiddevice structure complexity
Core Design Contradiction:
ReliabilityVSDevice complexity

Solution Approach 1:

The patent routes the optical fiber through the interior of the catheter structure rather than externally. The fiber is nested within the catheter wall or lumen, emerging at the distal tip near the sensor. This internal routing maintains data transmission capability while simplifying the overall device structure and reducing the risk of fiber damage during catheter manipulation

Inventive Principle:
Principle #7Nested doll (Nesting)

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 precise pressure measurements in coronary arteries and other vascular structures, aiding in therapy decisions by providing accurate data on blood pressure gradients and vessel functionality, while minimizing trauma and navigating through complex anatomical pathways effectively.

Implementation Method 1

The sensor assembly may include a fiber optic sensor such as a pressure sensor

Methodology Applied
Scientific EffectFiber optic sensing: Optical Fibre

Data Source

PatentEP3508116B1Fiber optic sensor assembly for sensor delivery device
Publication Date: 2024.04.10 ACIST MEDICAL SYSTEMS INC
  • EP3508116B1 patent drawingFigure 1
  • EP3508116B1 patent drawingFigure 2~3
  • EP3508116B1 patent drawingFigure 4~5

AI summary

Methods and sensor delivery devices for monitoring a fluid pressure within a vascular structure, the devices including an elongated sheath sized for sliding along a guidewire, a sensor assembly including a fiber optic sensor, a housing surrounding the sensor, a first cavity between the distal end of the sensor and a distal aperture of the housing, a filler extending from at least the distal end of the housing distally and tapering inward toward the outer surface of the sheath, a second cavity in the filler with an opening at the outer surface of the filler and adjoining the distal aperture of the housing, and an optical fiber. The sensor delivery device may also include an outer layer that partially covers the second cavity with an aperture over the opening of the second cavity.