Mitral Cerclage Wire Routing via Safe Zone Catheter

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Solution Overview

Problem

Current percutaneous cerclage annuloplasty procedures for treating mitral regurgitation are technically demanding and risk tissue entrapment, particularly when guiding tensioning elements through the heart, which can lead to serious adverse outcomes.

Innovation Solution

The development of specialized catheters and devices that facilitate the proper positioning and guidance of cerclage wires through a defined 'safe zone' within the heart, avoiding critical cardiac structures and minimizing the risk of tissue entrapment.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Ease of manufacture

If percutaneous cerclage annuloplasty is performed to treat mitral regurgitation, then the invasiveness and recovery time are reduced, but the risk of tissue entrapment and procedural complexity increase

Engineering Contradiction:

Improveinvasiveness of procedureVSAvoidprocedural complexity

Core Design Contradiction:

Ease of manufactureVSDevice complexity

Solution Approach 1:

The procedure is divided into distinct sequential steps: coronary sinus access, wire advancement through the septum, RVOT traversal, and tension application. Each step uses specialized devices designed for that specific function, breaking down the complex procedure into manageable segments that reduce overall procedural complexity despite the minimally invasive approach

Inventive Principle:

Principle #1Segmentation

Solution Approach 2:

A cerclage wire acts as an intermediary element that connects the externally applied tension to the mitral annulus. The wire traverses through the coronary sinus and RVOT, serving as a mediator that allows force transmission without requiring direct surgical access to the heart, thus reducing invasiveness while managing complexity through a dedicated intermediate component

Inventive Principle:

Principle #24Intermediary (Mediator)

2Reliability

If tensioning elements are guided through the heart to apply therapeutic tension, then the effectiveness of valve repair is improved, but the risk of damaging critical cardiac structures increases

Engineering Contradiction:

Improveeffectiveness of valve repairVSAvoidrisk of tissue damage

Core Design Contradiction:

ReliabilityVSObject-affected harmful factors

Solution Approach 1:

The tensioning mechanism is extracted from the heart cavity and positioned externally, with only the cerclage wire remaining inside. The catheter and tensioning device are removed after wire deployment, eliminating the need to leave foreign objects in the heart and reducing the risk of damage to critical structures while maintaining repair effectiveness through external tension application

Inventive Principle:

Principle #2Taking out (Extraction)

Solution Approach 2:

The cerclage wire is advanced and positioned through the coronary sinus and RVOT before any tension is applied. This preliminary positioning ensures the wire is correctly placed around the mitral annulus and clear of critical structures like the tricuspid valve and moderator band before the actual repair action begins, preventing tissue damage while ensuring repair effectiveness

Inventive Principle:

Principle #10Preliminary action

3Productivity

If cerclage wire is passed through the RVOT and safe zone, then the mitral valve can be tightened effectively, but the difficulty of procedure and risk of tissue entrapment increase

Engineering Contradiction:

Improveeffectiveness of mitral valve tighteningVSAvoiddifficulty of wire positioning

Core Design Contradiction:

ProductivityVSEase of operation

Solution Approach 1:

The natural anatomical pathways (coronary sinus and RVOT) are used as pre-formed conduits to guide the cerclage wire, replacing the need for complex mechanical manipulation through heart tissue. This substitution of anatomical pathways for mechanical routing simplifies wire positioning while maintaining effective mitral valve tightening

Inventive Principle:

Principle #28Mechanics substitution (Replace mechanical system)

Solution Approach 2:

The wire is extracted from the coronary sinus and advanced through the RVOT exit into the right ventricle, where it is captured and pulled back through the safe zone. This extraction and repositioning maneuver allows the wire to be routed through predetermined safe pathways, reducing procedural difficulty and tissue entrapment risk while achieving effective valve tightening

Inventive Principle:

Principle #2Taking out (Extraction)

Data Source

PatentUS20250025302A1RVOT wire capturing (RWC) system in mitral valve cerclage annuloplasty

Publication Date: 2025.01.23 TAU MEDICAL INC

AI summary

A mitral cerclage annuloplasty apparatus comprising of a catheter with a blocking member and a capturing member. The blocking member is in the shape of a pigtail or a balloon, and is configured on the distal portion of the catheter preventing the catheter from traversing through an unsafe zone thereby enabling the catheter to pass through the safe zone. This prevents damage to critical cardiac tissues. The capturing member is adapted for pulling out a RVOT cerclage wire into the IVC, and comprises of an expandable and collapsible mesh so that the RVOT cerclage wire is captured and directed into the IVC through the safe zone. Thus the RVOT cerclage wire is passed through the RV without damaging the heart tissue forming a complete circle around the mitral valvular annulus.