Self-Centering Guide Catheter Aligns With Blood Flow

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Solution Overview

Problem

Current methods for treating valvular stenosis, such as TAVR and valvuloplasty, face challenges in aligning a guide catheter with the valve orifice against the high-pressure blood flow, leading to increased risk of dislodging calcified debris and radiation exposure, and require random probing which is time-consuming.

Innovation Solution

A self-centering guide catheter device with a collapsible and self-expanding framework, featuring a biocompatible membrane and elongate metal frame members, aligns itself with the blood flow stream by using a centering device that reconfigures from a low-profile to an expanded configuration, allowing the guidewire to pass through the valve orifice without substantial contact with the valve leaflets.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If random probing of the stenotic valve with guide wire is used to find the orifice, then the valve orifice can be penetrated, but the risk of dislodging calcified debris and atheroma increases leading to strokes

Engineering Contradiction:
Improvesuccess rate of penetrating valve orificeVSAvoidrisk of dislodging calcified debris and atheroma
Core Design Contradiction:
ReliabilityVSObject-affected harmful factors

Solution Approach 1:

The guide catheter is equipped with a self-centering device that automatically aligns the catheter with the valve orifice using the high-pressure blood flow jet itself as the alignment mechanism. The device allows the blood flow to impinge on its inner surface, generating lateral forces that center the catheter on the orifice without requiring manual probing, thereby eliminating the harmful effect of random probing while maintaining the ability to penetrate the valve orifice

Inventive Principle:
Principle #25Self-service

Solution Approach 2:

The high-pressure blood flow jet, which was previously a harmful factor making alignment difficult and causing random probing, is converted into a beneficial alignment mechanism. The self-centering device harnesses the kinetic energy and directional force of the blood flow to automatically center the catheter on the valve orifice, transforming the problematic high-pressure flow into the very mechanism that achieves precise alignment and prevents debris dislodgement

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

2Reliability

If random probing is used to align the catheter with the valve orifice, then the orifice can be found, but the procedure becomes time-consuming

Engineering Contradiction:
Improveability to locate valve orificeVSAvoidprocedure duration
Core Design Contradiction:
ReliabilityVSLoss of time

Solution Approach 1:

The self-centering device performs the alignment function automatically using the blood flow jet as the guiding force. When the catheter is positioned near the valve, the high-pressure blood flow automatically centers the device on the orifice without requiring the operator to perform time-consuming manual probing movements, significantly reducing procedure time while maintaining reliable orifice location

Inventive Principle:
Principle #25Self-service

Solution Approach 2:

The manual mechanical probing process is replaced with an automated fluid-dynamic alignment system. Instead of the operator manually manipulating the catheter to find the orifice, the self-centering device uses the kinetic energy and pressure differential of the blood flow to automatically position the catheter centrally on the valve orifice, eliminating the time-consuming nature of manual probing

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

3Ease of operation

If conventional guide catheter alignment methods are used against high-pressure blood flow, then the catheter can be positioned, but substantial contact with valve leaflets occurs increasing radiation exposure

Engineering Contradiction:
Improveability to position catheter against flowVSAvoidradiation exposure and leaflet contact
Core Design Contradiction:
Ease of operationVSObject-affected harmful factors

Solution Approach 1:

The high-pressure blood flow that previously made alignment difficult and caused excessive manipulation is converted into a beneficial self-alignment mechanism. The self-centering device allows the blood flow to automatically center the catheter on the orifice, eliminating the need for substantial manual manipulation and reducing radiation exposure while maintaining the ability to position the catheter against the flow direction

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

Solution Approach 2:

The self-centering device acts as an intermediary between the blood flow and the guide catheter. It translates the kinetic energy and directional force of the blood flow into precise alignment of the catheter with the valve orifice, mediating the interaction between flow and catheter to achieve positioning without substantial contact with valve leaflets and minimal radiation exposure

Inventive Principle:
Principle #24Intermediary (Mediator)

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

This solution reduces the risk of thromboembolic strokes, minimizes radiation exposure, and streamlines the procedure by quickly aligning the guide catheter with the valve orifice, enhancing the efficiency of cardiac catheterization procedures and reducing the risk of complications.

Implementation Method 1

The inner surface of the self-centering device is configured to receive a jet flow of fluid (e.g., blood) from an orifice. The impact forces generated by the jet flow on the inner surface of the device center the device on the orifice.

Methodology Applied
Scientific EffectFluid flow impact force: Impact Force

Data Source

PatentUS11833042B2Device and methods for self-centering a guide catheter
Publication Date: 2023.12.05 MAYO FOUNDATION FOR MEDICAL EDUCATION & RESEARCH
  • US11833042B2 patent drawing
  • US11833042B2 patent drawing
  • US11833042B2 patent drawing

AI summary

This document provides devices and methods for the treatment of heart conditions such as valvular stenosis. For example, this document provides devices and methods by which a guide catheter can align itself with a blood flow stream to thereby help direct a guidewire or other elongate device transmitted from the guide catheter through an orifice of a heart valve.