Steerable Catheter for Mitral Valve Implant Delivery

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Solution Overview

Problem

Current surgical methods for correcting mitral regurgitation, such as open heart procedures, are invasive, risky, and often delayed until significant heart damage occurs, necessitating a less invasive and more timely solution for addressing dysfunctional heart valves.

Innovation Solution

A minimally invasive system and method using a transseptal approach with guide wires, dilators, and steerable catheters to implant a heart valve implant that interacts with existing heart valve cusps to prevent or reduce regurgitation, allowing for controlled delivery and securement within the heart without open-heart surgery.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If open heart surgical procedures are used to correct mitral regurgitation, then the valve can be repaired or replaced, but the procedure is invasive, risky, and requires the patient to be placed on a heart-lung machine

Engineering Contradiction:

Improvevalve repair effectivenessVSAvoidsurgical risk and invasiveness

Core Design Contradiction:

ReliabilityVSObject-affected harmful factors

Solution Approach 1:

A catheter system serves as an intermediary device to deliver the mitral valve implant percutaneously through the femoral vein and across the mitral valve, avoiding open heart surgery. The catheter navigates through the bloodstream and positions the implant at the target location without requiring surgical incision into the heart chambers.

Inventive Principle:

Principle #24Intermediary (Mediator)

Solution Approach 2:

The patent replaces the mechanical open heart surgical system with a minimally invasive percutaneous delivery system. Instead of surgically exposing the heart and using surgical tools, the implant is delivered through a flexible catheter that can be guided through the vascular system and positioned across the mitral valve using fluoroscopic and echocardiographic imaging guidance.

Inventive Principle:

Principle #28Mechanics substitution (Replace mechanical system)

2Reliability

If open heart surgery is performed for mitral regurgitation correction, then the valve dysfunction can be addressed, but the surgery lasts three to five hours and requires general anesthesia

Engineering Contradiction:

Improvevalve repair effectivenessVSAvoidprocedure duration

Core Design Contradiction:

ReliabilityVSLoss of time

Solution Approach 1:

The patent replaces the time-consuming open heart surgical procedure with a percutaneous catheter-based delivery system. The minimally invasive approach eliminates the need for sternotomy, cardiopulmonary bypass cannulation, and direct surgical exposure of the heart, thereby significantly reducing procedure time while maintaining valve repair effectiveness.

Inventive Principle:

Principle #28Mechanics substitution (Replace mechanical system)

3Object-affected harmful factors

If corrective surgery is delayed until ejection fraction drops below 60% or left ventricle exceeds 45 mm, then surgical risk is reduced, but heart damage progresses and cardiac output decreases

Engineering Contradiction:

Improvesurgical riskVSAvoidcardiac function

Core Design Contradiction:

Object-affected harmful factorsVSReliability

Solution Approach 1:

The percutaneous mitral valve implant system enables earlier intervention for mitral regurgitation before significant heart damage occurs. By providing a lower-risk alternative to open heart surgery, the procedure can be performed at an earlier stage when the patient's ejection fraction is still preserved and the left ventricle has not yet dilated beyond 45 mm, thereby preventing further cardiac deterioration.

Inventive Principle:

Principle #10Preliminary action

4Object-affected harmful factors

If a minimally invasive percutaneous approach is used to implant a mitral valve, then surgical risk is reduced, but the delivery system must navigate complex cardiac anatomy through small vessels

Engineering Contradiction:

Improvesurgical riskVSAvoidcatheter navigation system

Core Design Contradiction:

Object-affected harmful factorsVSDevice complexity

Solution Approach 1:

The catheter acts as an intermediary delivery vehicle that navigates through the femoral vein, right atrium, and across the mitral valve to reach the implantation site. The system includes guidewires, delivery catheters, and positioning mechanisms that guide the implant through the complex cardiac anatomy without requiring open surgical access.

Inventive Principle:

Principle #24Intermediary (Mediator)

Solution Approach 2:

The delivery system utilizes changes in catheter configuration and stiffness along its length to navigate different anatomical regions. The catheter is designed with varying flexibility zones that allow it to conform to the curvature of the vascular system and heart chambers while maintaining positional control for accurate implant placement.

Inventive Principle:

Principle #35Parameter changes

Data Source

PatentUS8591460B2Steerable catheter and dilator and system and method for implanting a heart implant

Publication Date: 2013.11.26 CARDIOSOLUTIONS INC

AI summary

A catheter according to one embodiment may be configured to extend through a transseptal puncture site, a left atrium, and into a left ventricle. The catheter may comprise a shaft defining at least one lumen configured to receive at least one of an implant and/or a dilator, a first steerable actuator coupled to the shaft at a position on the shaft substantially corresponding to the annulus of the mitral valve when the distal end of the shaft is disposed within the left ventricle, and a handle assembly coupled to a proximal end of the shaft. The handle assembly may comprise a first actuator coupled to the first steerable actuator. The first actuator may be configured to apply a force to the first steerable actuator to deflect the shaft about a region proximate to the first steerable actuator.