Sheath-Dilator System with Blood Detection for Vascular Access

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Solution Overview

Problem

Existing sheath-dilator systems for endoscopic and endovascular surgery are costly due to radiopaque materials and suffer from geometric constraints that hinder the delivery of therapeutic equipment, especially when dealing with non-uniform sizes and shapes.

Innovation Solution

A sheath-dilator system with a removable dilator featuring blood detectors, depth indicators, and radiopaque markers, which allows for precise positioning and calibration within a vessel using blood inlet openings and sensors, enabling accurate insertion and monitoring of the sheath's position relative to the artery.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Illumination intensity

If radiopaque materials are used in the introducer sheath tip, then visualization of the item within the body is improved, but the cost associated with production is substantially increased

Engineering Contradiction:

Improvevisualization capabilityVSAvoidproduction cost

Core Design Contradiction:

Illumination intensityVSEase of manufacture

Solution Approach 1:

The patent replaces expensive permanent radiopaque materials with a disposable, cost-effective alternative. The introducer sheath is designed as a single-use device where the tip can be easily replaced or the entire sheath is discarded after one use, eliminating the need for costly radiopaque materials like gold while maintaining visualization capabilities through fluoroscopic markers.

Inventive Principle:

Principle #27Cheap short-living objects (Disposable)

Solution Approach 2:

The patent changes the material composition parameter of the sheath tip from expensive radiopaque materials to more economical alternatives. By modifying the material properties and using fluoroscopic markers instead of inherent radiopacity, the system achieves the same visualization function at a lower cost.

Inventive Principle:

Principle #35Parameter changes

2Illumination intensity

If radiopaque materials such as gold are used on the distal tip, then tip location visualization is improved, but geometric constraints are created that hinder delivery of therapeutic equipment

Engineering Contradiction:

Improvetip location visualizationVSAvoiddelivery of therapeutic equipment

Core Design Contradiction:

Illumination intensityVSAdaptability or versatility

Solution Approach 1:

The patent segments the visualization function from the structural function. The radiopaque or fluoroscopic markers are separated as distinct elements from the main sheath body and tip, allowing the tip to be designed with optimal geometry for equipment delivery while maintaining visualization capabilities through attached or integrated markers.

Inventive Principle:

Principle #1Segmentation

Solution Approach 2:

The patent introduces fluoroscopic markers as an intermediary element that provides visualization without the geometric constraints of solid radiopaque materials. These markers can be thin, flexible, and conform to the sheath geometry, allowing therapeutic equipment to pass through freely while still providing tip location visualization.

Inventive Principle:

Principle #24Intermediary (Mediator)

3Stability of the object's composition

If the sheath tip is made rigid for structural stability, then positioning accuracy is improved, but trauma to blood vessels during insertion is increased

Engineering Contradiction:

Improvepositioning accuracyVSAvoidvascular trauma

Core Design Contradiction:

Stability of the object's compositionVSObject-affected harmful factors

Solution Approach 1:

The patent makes the sheath tip dynamic by designing it to transition from a flexible state during insertion to a stabilized state during use. The tip may incorporate features that allow it to bend or conform during insertion to reduce trauma, then maintain positioning stability once deployed, balancing flexibility and rigidity through dynamic design.

Inventive Principle:

Principle #15Dynamics

Solution Approach 2:

The patent applies beforehand cushioning by designing the tip with features that prevent trauma before it occurs. This may include tapered geometries, flexible materials, or protective coatings on the tip that cushion the insertion process and prevent vessel damage, while still maintaining adequate structural support for positioning accuracy.

Inventive Principle:

Principle #11Beforehand cushioning (Prior cushioning)

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 provides a cost-effective and atraumatic method for inserting and removing medical devices, ensuring precise placement and minimizing blood loss by using blood detectors and sensors to calibrate the sheath's position within the artery, thus facilitating efficient vascular access.

Implementation Method 1

a blood detector, which may be used to calibrate the location of the sheath-dilator system with respect to an artery

Methodology Applied

Scientific EffectBlood detection:

Data Source

PatentUS20210045723A1Sheath-dilator system and uses thereof

Publication Date: 2021.02.18 VIVASURE MEDICAL LTD

AI summary

A medical device includes a sheath having a proximal end and a distal end, the sheath having an opening at both the proximal end and the distal end, and a removable dilator having a distal end and a proximal end, the dilator having at least one blood detector disposed on a tapered portion of the distal end of the dilator, the dilator positionable within the sheath such that the tapered portion of the distal end of the dilator extends through the opening in the distal end of the sheath, the proximal end of the dilator extends through the opening in the proximal end of the sheath, and at least a portion of the at least one blood detector is adjacent to the distal end of the sheath.