Multi-Branch Catheter for Aortic Valve Imaging Alignment

Resolve Bottlenecks,
Find Innovative SolutionsGenerate Solutions

Solution Overview

Problem

Current transcatheter aortic valve replacement (TAVR) procedures face challenges in accurately imaging the aortic valve and efficiently orienting catheters due to reliance on conventional pigtail catheters, which require multiple contrast dye injections and are inefficient for visualizing all three aortic valve leaflets, particularly in patients with certain medical conditions, and struggle with advancing instruments across the valve.

Innovation Solution

A catheter system with multiple distal branches that can engage each aortic valve leaflet for precise imaging and instrument alignment, allowing for coaxial orientation and reduced contrast dye use, enabling efficient visualization and instrument placement without relying solely on contrast dye injection.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If a conventional pigtail catheter is used for imaging the aortic valve, then the procedure can be performed with standard equipment, but the imaging is unreliable and requires multiple contrast dye injections

Engineering Contradiction:

Improveimaging reliabilityVSAvoidcontrast dye volume

Core Design Contradiction:

ReliabilityVSQuantity of substance

Solution Approach 1:

The catheter is divided into multiple distal branches (typically three) that can be independently positioned against the aortic valve leaflets. Each branch contains a contrast injection lumen, allowing selective and simultaneous injection of contrast dye at multiple locations across the valve, enabling complete visualization in a single injection rather than requiring multiple injections through a single pigtail catheter

Inventive Principle:

Principle #1Segmentation

Solution Approach 2:

The multi-branch catheter serves multiple functions simultaneously: it acts as an imaging device by injecting contrast dye through multiple branches, as an alignment device by positioning branches against valve leaflets to define the coaxial plane, and as a guide for instrument advancement. This multi-functionality eliminates the need for separate devices and procedures

Inventive Principle:

Principle #6Universality (Multi-functionality)

2Loss of information

If multiple contrast dye injections are performed to visualize all aortic valve leaflets, then complete visualization can be achieved, but patient exposure to contrast dye and radiation increases

Engineering Contradiction:

Improvevalve visualization completenessVSAvoidpatient exposure to contrast dye and radiation

Core Design Contradiction:

Loss of informationVSObject-affected harmful factors

Solution Approach 1:

By segmenting the contrast injection function across multiple distal branches, the catheter can visualize all three aortic valve leaflets simultaneously in a single injection. The branches are positioned to align with each leaflet, allowing complete valve visualization without requiring multiple sequential injections, thereby reducing cumulative contrast dye exposure and associated radiation exposure from repeated fluoroscopic imaging

Inventive Principle:

Principle #1Segmentation

3Ease of operation

If a curved catheter is used for retrograde crossing of the aortic valve, then instrument advancement can be achieved, but considerable manipulation is required especially for high stenosis

Engineering Contradiction:

Improveinstrument advancement easeVSAvoidprocedural time

Core Design Contradiction:

Ease of operationVSLoss of time

Solution Approach 1:

The distal branches are pre-formed with a curved configuration that matches the anatomy of the aortic valve approach. The branches are positioned against the valve leaflets in advance to establish the coaxial plane and alignment, creating a pre-positioned pathway that guides subsequent instrument advancement. This preliminary positioning eliminates the need for considerable manipulation during the crossing procedure, even for high-grade stenosis

Inventive Principle:

Principle #10Preliminary action

Solution Approach 2:

The distal branches act as an intermediary structure that facilitates instrument crossing. By positioning the branches against the valve leaflets, they create a stable framework and alignment reference that mediates the complex interaction between the catheter system and the stenotic valve, enabling smoother and faster instrument advancement

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 system enhances the precision and efficiency of TAVR procedures by allowing clear visualization of the aortic valve complex without extensive contrast dye use, reducing patient exposure, and facilitating easier instrument placement across the valve, improving procedural efficiency and safety for high-risk patients.

Implementation Method 1

At or near the distal end of each of the three distal branches, there is one radiographic marker... the radiographic markers can be used to determine the co-axial plane of radiographic projection

Methodology Applied

Scientific EffectX-Ray: X-Ray

Data Source

PatentUS10507301B2Pigtail for optimal aortic valvular complex imaging and alignment

Publication Date: 2019.12.17 CEDARS SINAI MEDICAL CENT

AI summary

Devices, systems and methods using two, three or more pigtails for precisely imaging an aortic valve complex with minimal contrast and/or for advancing an instrument, such as a wire, or device, such as a transcatheter valve, across an aortic valve. These devices, systems and methods may be used to diagnose and/or treat patients with aortic stenosis, other valvular heart disease or other cardiovascular or non cardiovascular disease, facilitating precise contrast or drug or device delivery, precise pressure measurement and/or precise drainage or sampling.