Transcatheter Heart Splints for Ventricular and Valve Reshaping

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Solution Overview

Problem

Current methods for treating heart failure, particularly dilated hearts and mitral valve regurgitation, require invasive procedures involving cardiopulmonary bypass, which introduce additional complications, and existing treatments for heart valve annulus expansion and leaflet prolapse are complex and potentially damaging.

Innovation Solution

A minimally invasive system using heart splints with anchors and tension members to reshape the heart, applied via a beating-heart procedure, which can be deployed without cardiopulmonary bypass, and includes anchors for septal defects, valve annulus reshaping, and leaflet repositioning.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If traditional surgical methods are used to treat dilated hearts and mitral valve regurgitation, then direct access to the valve and annulus is achieved, but cardiopulmonary bypass is required which introduces additional complications

Engineering Contradiction:
Improvetreatment effectivenessVSAvoidcomplications from cardiopulmonary bypass
Core Design Contradiction:
ReliabilityVSObject-affected harmful factors

Solution Approach 1:

The invention extracts the essential function of heart surgery (valve repair and reshaping) while removing the harmful element of cardiopulmonary bypass. The system achieves direct heart access through minimally invasive percutaneous techniques, eliminating the need for full surgical opening and bypass while maintaining treatment effectiveness.

Inventive Principle:
Principle #2Taking out (Extraction)

Solution Approach 2:

The invention introduces an intermediary access method - percutaneous delivery systems that allow catheters and splints to be introduced through small skin incisions rather than requiring full sternotomy and cardiopulmonary bypass. This intermediary approach maintains the ability to reach the heart valve while avoiding the harmful effects of traditional surgical access.

Inventive Principle:
Principle #24Intermediary (Mediator)

2Object-affected harmful factors

If minimally invasive procedures are used to apply splints, then cardiopulmonary bypass is avoided, but direct access to the heart is difficult to achieve

Engineering Contradiction:
Improveavoidance of cardiopulmonary bypassVSAvoidaccess to heart
Core Design Contradiction:
Object-affected harmful factorsVSEase of operation

Solution Approach 1:

The invention uses percutaneous delivery systems as intermediaries that can be introduced through small skin incisions and navigated to the heart using imaging guidance. This intermediary approach provides both minimally invasive access (avoiding bypass) and effective heart targeting (through guided delivery of splints and anchors).

Inventive Principle:
Principle #24Intermediary (Mediator)

Solution Approach 2:

The invention replaces the mechanical system of full surgical opening and manual manipulation with a percutaneous system using imaging guidance (echocardiography, fluoroscopy, or other imaging modalities) to guide the delivery of splints and anchors to the heart, achieving both minimally invasive access and precise targeting.

Inventive Principle:
Principle #28Mechanics substitution (Replace mechanical system)

3Reliability

If existing treatments for heart valve annulus expansion and leaflet prolapse are used, then valve function is addressed, but the procedures are complex and potentially damaging

Engineering Contradiction:
Improvevalve function improvementVSAvoidprocedure complexity
Core Design Contradiction:
ReliabilityVSDevice complexity

Solution Approach 1:

The invention segments the complex valve repair procedure into discrete, manageable components: percutaneous delivery of individual splints, separate deployment of anchors at specific locations, and modular adjustment of tension members. This segmentation simplifies the overall procedure while maintaining effective valve function improvement.

Inventive Principle:
Principle #1Segmentation

Solution Approach 2:

The invention uses dynamic, adjustable splints with variable tension members that can be customized to the patient's specific anatomical requirements. The splints can be adjusted post-deployment to optimize valve coaptation and annular geometry, providing a simpler and more adaptable alternative to fixed, complex surgical repairs.

Inventive Principle:
Principle #15Dynamics

Data Source

PatentUS20250352344A1Methods and devices for ventricular reshaping and heart valve reshaping
Publication Date: 2025.11.20 EDWARDS LIFESCIENCES CORP
  • US20250352344A1 patent drawing
  • US20250352344A1 patent drawing
  • US20250352344A1 patent drawing

AI summary

Systems, apparatuses, and methods disclosed herein are provided for medical treatment, including transcatheter medical treatments and/or for treatment of dilated hearts (e.g., dilated left ventricle) or functional mitral valve regurgitation within a human heart. The systems, apparatuses, and methods disclosed herein may include applying one or more heart splints to the patient's heart to apply pressure to the heart to reshape the heart. Anchors disclosed herein may be utilized in plugs for treating openings in a septum between two chambers of a heart, e.g., ventricular septal defects (VSD), atrial septal defects (ASD), and patent foramen ovale (PFO). In addition, the anchors disclosed herein may be utilized to reshape an annulus of a patient's heart valve, including a tricuspid valve of a patient's heart. The anchors disclosed herein may also be utilized to reposition a heart valve leaflet to reduce heart valve leaflet prolapse.