Automated Arterial Sheath Placement with Doppler Localization

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Solution Overview

Problem

Current methods for femoral artery cannulation require advanced training and are challenging to perform in emergency settings where trained personnel may not be available, especially when the femoral pulse is absent or decreased due to hypotension, limiting the applicability of procedures like REBOA and invasive monitoring.

Innovation Solution

A hand-held automated emergency arterial sheath placement device with a Doppler sensor for non-invasive artery localization and a manually operable actuator to guide the insertion of an arterial sheath, scalpel, and other necessary elements, allowing for quick and safe cannulation by personnel without specialized training.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If conventional femoral artery cannulation is performed by trained physicians, then cannulation accuracy and safety are improved, but procedure complexity and time consumption increase, limiting emergency response capability

Engineering Contradiction:
Improvecannulation accuracyVSAvoidprocedure complexity
Core Design Contradiction:
ReliabilityVSDevice complexity

Solution Approach 1:

The device segments the complex cannulation procedure into distinct functional modules: Doppler sensor for artery localization, automated needle insertion mechanism, guide wire deployment system, and sheath placement mechanism. Each module operates independently but coordinates through automated control, reducing the cognitive burden on operators while maintaining procedural accuracy

Inventive Principle:
Principle #1Segmentation

Solution Approach 2:

The device performs self-localization of the femoral artery using integrated Doppler sensors that automatically detect blood flow signals and guide needle positioning. The system self-adjusts insertion depth and angle based on real-time feedback from pressure sensors and imaging, eliminating the need for continuous manual assessment by trained physicians

Inventive Principle:
Principle #25Self-service

2Adaptability or versatility

If manual femoral artery cannulation is performed, then procedural flexibility is maintained, but operator training requirements and time consumption increase

Engineering Contradiction:
Improveprocedural flexibilityVSAvoidtime consumption
Core Design Contradiction:
Adaptability or versatilityVSLoss of time

Solution Approach 1:

The device performs preliminary artery localization and positioning using Doppler sensors and imaging systems before needle insertion. The system pre-configures optimal insertion parameters based on patient anatomy detection, eliminating time-consuming manual assessment steps while maintaining adaptability to individual patient variations

Inventive Principle:
Principle #10Preliminary action

Solution Approach 2:

Real-time feedback from pressure sensors, Doppler flow detection, and imaging systems continuously monitors needle position and artery engagement. The system automatically adjusts insertion depth and angle based on feedback signals, maintaining procedural flexibility while reducing time consumption through automated closed-loop control

Inventive Principle:
Principle #23Feedback

3Productivity

If automated sheath placement device is used, then procedure time is reduced and accessibility is improved, but device complexity and initial training requirements increase

Engineering Contradiction:
Improveprocedure speedVSAvoiddevice complexity
Core Design Contradiction:
ProductivityVSDevice complexity

Solution Approach 1:

The device merges multiple functions (Doppler sensing, imaging, needle insertion, guide wire deployment, and sheath placement) into a single integrated platform. This consolidation reduces the number of separate devices and manual coordination steps required, improving procedure speed while managing complexity through unified automated control

Inventive Principle:
Principle #5Merging (Combining)

Solution Approach 2:

The device is designed with universal applicability across different patient populations and clinical settings through adjustable parameters and multiple functional modes. The same platform can perform artery localization, needle insertion, guide wire deployment, and sheath placement, reducing the need for multiple specialized devices and simplifying training requirements

Inventive Principle:
Principle #6Universality (Multi-functionality)

4Reliability

If advanced training is required for femoral artery cannulation, then procedural safety is improved, but availability of trained personnel in emergency settings decreases

Engineering Contradiction:
Improveprocedural safetyVSAvoidoperator accessibility
Core Design Contradiction:
ReliabilityVSEase of operation

Solution Approach 1:

The device performs self-localization of the femoral artery using integrated Doppler sensors that automatically detect blood flow signals and guide needle positioning. The system self-adjusts insertion depth and angle based on real-time feedback from pressure sensors and imaging, eliminating the need for continuous manual assessment by trained physicians

Inventive Principle:
Principle #25Self-service

Solution Approach 2:

Manual tactile assessment and physician skill-based judgment are replaced with automated electronic sensing systems including Doppler sensors, pressure transducers, and imaging systems. These electronic systems objectively detect artery location and guide insertion, transferring the safety function from human expertise to automated mechanical-sensing systems

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 rapid and accurate femoral artery sheath placement in emergency conditions by non-physician emergency providers, reducing complications and increasing accessibility of invasive monitoring and resuscitative techniques in pre-hospital settings.

Implementation Method 1

The lower body portion includes a non-invasive artery locator, such as a Doppler sensor configured to locate an artery into which the arterial sheath is intended to be placed

Methodology Applied
Scientific EffectDoppler effect: Doppler Effect

Data Source

PatentEP3319677B1Device and method for automated emergency arterial sheath placement
Publication Date: 2023.04.19 UNIV OF MARYLAND
  • EP3319677B1 patent drawingFigure 1
  • EP3319677B1 patent drawingFigure 2
  • EP3319677B1 patent drawingFigure 3a~3b

AI summary

Disclosed are devices and methods for automated emergency arterial cannulation. The device comprises a hand-held automated emergency arterial sheath placement device having a body with a handle and an actuator, and an arterial sheath placement head at the distal end of the handle body configured for placement against the patient's skin. The arterial sheath placement head includes an arterial sheath insertion device configured to advance an arterial needle, guide wire, and arterial sheath into a patient's artery upon sequential operation of the actuator. The arterial sheath placement head also includes a non-invasive artery locator configured to locate an artery into which the arterial sheath is intended to be placed. The arterial sheath placement head also preferably includes a Doppler gel and antiseptic needle, a local anesthetic needle, and a scalpel, all of which are likewise configured to advance from the upper body portion upon sequential operation of the actuator.