Bifurcated Catheter Stabilization for Hostile Aortic Arch

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Solution Overview

Problem

Stenting procedures in carotid arteries, particularly in type III hostile aortic arches, face challenges due to the tortuous nature of the aortic arch, leading to difficulties in accessing and stabilizing the left or right carotid arteries, which can result in arterial injuries and increased risk of cerebral embolism or stroke.

Innovation Solution

A coronary percutaneous intervention system utilizing a bifurcated catheter with a wide and narrow lumen, where the narrow lumen is used for stabilization and the wide lumen for procedural instruments, along with a stabilization wire and snare wire configuration to stabilize the system during procedures, allowing for safer access and deployment of stents in tortuous vessels.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Ease of operation

If a guide catheter is used to access the carotid artery in a type III hostile aortic arch, then the catheter can reach the target vessel, but the catheter becomes unstable and difficult to control due to the tortuous arch geometry

Engineering Contradiction:

Improvecatheter stabilityVSAvoidcatheter system complexity

Core Design Contradiction:

Ease of operationVSDevice complexity

Solution Approach 1:

The catheter system is divided into multiple functional segments: a guide catheter for navigation, a stabilization wire for anchoring, and a stent delivery system for treatment. This segmentation allows each component to perform its specific function optimally while working together to overcome the tortuous arch geometry.

Inventive Principle:

Principle #1Segmentation

Solution Approach 2:

A stabilization wire is introduced as an intermediary element that extends from the guide catheter into the aortic arch and is secured against the vessel wall. This intermediary provides mechanical stabilization and support, enabling better control of the guide catheter and stent delivery system in the challenging anatomy.

Inventive Principle:

Principle #24Intermediary (Mediator)

2Stability of the object's composition

If the catheter is stabilized using additional wires and support structures, then catheter stability improves, but the procedure complexity and time increase

Engineering Contradiction:

Improvecatheter stabilityVSAvoidprocedure time

Core Design Contradiction:

Stability of the object's compositionVSLoss of time

Solution Approach 1:

The stabilization wire is deployed and secured in the aortic arch before the stent delivery system is advanced. This preliminary stabilization action creates a stable platform that facilitates smoother and faster subsequent steps, reducing overall procedure time despite the additional initial step.

Inventive Principle:

Principle #10Preliminary action

Solution Approach 2:

The guide catheter serves multiple functions: it provides a pathway for the stabilization wire, supports the stent delivery system, and maintains access to the carotid artery throughout the procedure. This multi-functionality reduces the need for additional specialized devices and streamlines the overall procedure.

Inventive Principle:

Principle #6Universality (Multi-functionality)

3Adaptability or versatility

If the aortic arch is very acute (type III), then the anatomical challenge increases, but the risk of arterial injury and cerebral embolism increases

Engineering Contradiction:

Improveanatomical adaptabilityVSAvoidarterial injury risk

Core Design Contradiction:

Adaptability or versatilityVSObject-affected harmful factors

Solution Approach 1:

The system accommodates varying arch geometries by allowing adjustment of the stabilization wire position and angle. The wire can be secured at different locations along the aortic arch depending on the specific anatomy, enabling adaptation to type III acute arches while maintaining safety and reducing injury risk.

Inventive Principle:

Principle #35Parameter changes

Solution Approach 2:

The stabilization wire acts as a cushioning element that absorbs mechanical stresses and prevents uncontrolled movement of the catheter system. By providing this protective stabilization beforehand, the system reduces the risk of arterial wall injury and embolism during manipulation in the acute arch.

Inventive Principle:

Principle #11Beforehand cushioning (Prior cushioning)

Data Source

PatentUS11020256B2Bifurcated “Y” anchor support for coronary interventions

Publication Date: 2021.06.01 RAM MEDICAL INNOVATIONS INC

AI summary

Systems and methods to provide end to end stabilization support to the operational catheter and reduce the need to stabilize or push from the lateral wall of the aorta during coronary interventions. This reduces the potential for stroke from plaque breaking off the wall of the aorta during intervention procedures. A support and stabilization wire having one end at the femoral percutaneous access and the second end at a radial percutaneous access is established for end to end stabilization. A bifurcated catheter having a wide lumen for procedural catheters and a narrow lumen for the support wire or catheter is advanced over the support wire to the aortic arch. A procedural catheter and a variety of different shaped guide wires may be deployed from the wide lumen of the bifurcated catheter into the right or left coronary artery to accommodate a range of aortic anatomical considerations during the coronary interventions.