Pre-curved Guide Catheter Capture System for Cardiac Valve Deployment

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Solution Overview

Problem

Current transcatheter procedures for heart valve treatment face challenges in ensuring precise and stable positioning of guide structures within cardiac chambers, which affects the reliability and invasiveness of the procedures.

Innovation Solution

A device comprising a multi-lumen introducer catheter with pre-formed and adjustable guide catheters, along with a capture system, allows for controlled navigation and precise placement of guide wires within cardiac chambers, enabling safer and more effective deployment of prosthetic systems for heart valve replacement.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If traditional surgical procedures are used for heart valve treatment, then complete access to the malfunctioning valve is achieved, but patient trauma and mortality risk increase significantly

Engineering Contradiction:

Improvetreatment efficacyVSAvoidpatient trauma

Core Design Contradiction:

ReliabilityVSObject-affected harmful factors

Solution Approach 1:

The procedure is divided into distinct stages: first deploying guide structures (guide wires, catheters) to establish positioning pathways, then subsequently deploying the prosthetic valve system along these pre-established guides. This segmentation allows the complex task to be performed through minimally invasive steps rather than requiring open surgical access.

Inventive Principle:

Principle #1Segmentation

Solution Approach 2:

Guide structures are deployed in advance before the main prosthetic valve implantation. These guide wires and catheters are positioned first to create reliable pathways and reference points, enabling the subsequent valve prosthesis to be accurately delivered and positioned without requiring traumatic surgical exposure.

Inventive Principle:

Principle #10Preliminary action

2Ease of operation

If guide structures are deployed without precise positioning control, then procedural simplicity is maintained, but positioning accuracy and procedural reliability deteriorate

Engineering Contradiction:

Improveprocedural simplicityVSAvoidguide structure positioning accuracy

Core Design Contradiction:

Ease of operationVSMeasurement precision

Solution Approach 1:

The system incorporates multiple feedback mechanisms including radiopaque markers visible under fluoroscopy, echocardiographic guidance, and mechanical reference points on the guide structures themselves. These allow the operator to continuously monitor and verify the position of guide wires and catheters, making real-time adjustments to achieve precise positioning while maintaining procedural simplicity.

Inventive Principle:

Principle #23Feedback

Solution Approach 2:

Guide structures serve as intermediary elements that mediate between the operator's control at the proximal end and the distal tip position within the heart. These intermediaries transmit mechanical forces, positioning information, and guidance signals, enabling precise control of the final device position without requiring direct manual manipulation at the implantation site.

Inventive Principle:

Principle #24Intermediary (Mediator)

3Reliability

If guide structures are made stable and fixed, then positioning reliability improves, but procedural reversibility and adaptability decrease

Engineering Contradiction:

Improvepositioning stabilityVSAvoidprocedural reversibility

Core Design Contradiction:

ReliabilityVSAdaptability or versatility

Solution Approach 1:

The guide structures are designed with dynamic characteristics - they can be deployed to provide stable positioning during the critical phases of the procedure, then subsequently removed or repositioned if needed. The system transitions from a flexible, easily deployable state to a stable, position-maintaining state, and back to a removable state, allowing both stability during operation and reversibility when required.

Inventive Principle:

Principle #15Dynamics

Solution Approach 2:

The procedure is designed with built-in safety margins and reversible steps. Guide structures are deployed in a sequence that allows for correction and repositioning before final commitment to the implantation. If positioning is not optimal, previously deployed guide elements can be adjusted or removed without compromising patient safety, cushioning against the consequences of positioning errors.

Inventive Principle:

Principle #11Beforehand cushioning (Prior cushioning)

Data Source

PatentEP4147676A1Device for deploying guide structures for operational procedures within the cardiac chambers

Publication Date: 2023.03.15 INNOVHEART SRL

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AI summary

A device for deploying guide structures for operational procedures within the cardiac chambers comprises a set of guide catheters (14) that can be advanced in a main lumen (12) of an introducer catheter, said guide catheters having a distal end (38) pre-curved, the distal ends of the two catheters being orientated along opposite directions, a capture device (22) that can be advanced in a further guide catheter (16) in a direction offset from an axis of the introducer; the device is suitable for advancing two guide wires (46) until they emerge into the cardiac chamber so that their distal ends (47) can be gripped by the capture device (22) .