Suture-Based Septal Defect Closure via Cinching Anchors

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Solution Overview

Problem

Current methods for closing septal defects in cardiac tissue are often invasive, riskier, and less effective, particularly due to the use of bulky devices that can interfere with heart valves and pose fatigue-related failure risks, and may not fully conform to the defect's anatomy.

Innovation Solution

The use of minimally-invasive systems that deploy suture-type tissue anchors around septal defects, which are cinched together with suture tails to close the defect, utilizing a delivery device with a shaft for precise deployment and a suture-locking mechanism to secure the closure, reducing the risk of detachment and improving conformity to the defect's anatomy.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If traditional bulky devices are used to close septal defects, then closure can be achieved, but the devices interfere with heart valves and pose fatigue-related failure risks

Engineering Contradiction:
Improvedevice durabilityVSAvoidvalve interference
Core Design Contradiction:
ReliabilityVSObject-affected harmful factors

Solution Approach 1:

The patent employs thin-film occluder devices instead of bulky structures. The occluder is constructed as a flexible membrane that can conform to the defect anatomy while maintaining a profile thin enough to avoid interfering with adjacent heart valves, thus resolving the contradiction between closure effectiveness and valve safety

Inventive Principle:
Principle #30Flexible shells and thin films

Solution Approach 2:

The closure device is divided into multiple independent components: an occluder element for sealing the defect, delivery catheters for positioning, and anchoring mechanisms for stabilization. This segmentation allows each component to be optimized independently, reducing overall bulk while maintaining functional effectiveness

Inventive Principle:
Principle #1Segmentation

2Reliability

If traditional closure methods are used, then defect closure can be achieved, but they are invasive and riskier

Engineering Contradiction:
Improveclosure effectivenessVSAvoidprocedure invasiveness
Core Design Contradiction:
ReliabilityVSEase of operation

Solution Approach 1:

The patent replaces traditional open-surgical mechanical closure with a percutaneous catheter-based system. The delivery catheter allows the occluder to be implanted through a small skin puncture, eliminating the need for large thoracic incisions and direct surgical exposure, thus reducing procedure invasiveness while maintaining closure effectiveness

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

Solution Approach 2:

The delivery catheter acts as an intermediary tool that facilitates the implantation process. It provides a minimally invasive pathway from the skin to the cardiac defect, enabling precise device placement without requiring direct surgical access to the heart, thereby reducing procedural risk and invasiveness

Inventive Principle:
Principle #24Intermediary (Mediator)

3Reliability

If bulky closure devices are used, then closure can be achieved, but they do not fully conform to the defect's anatomy

Engineering Contradiction:
Improveclosure sealingVSAvoidanatomical conformity
Core Design Contradiction:
ReliabilityVSShape

Solution Approach 1:

The occluder device incorporates shape-memory materials and flexible membranes that can change their physical parameters (flexibility, conformability) to match the specific geometry of the defect. This allows the device to adapt its shape to the defect's anatomy, achieving precise sealing without requiring a bulky standardized structure

Inventive Principle:
Principle #35Parameter changes

Solution Approach 2:

The occluder is designed with non-uniform thickness and localized reinforcement patterns that provide different mechanical properties at different locations. This local quality variation allows the device to conform to complex defect geometries while maintaining adequate sealing, replacing the need for uniformly bulky structures

Inventive Principle:
Principle #3Local quality

4Manufacturing precision

If suture-type tissue anchors are deployed around septal defects, then precise closure can be achieved, but the delivery device complexity increases

Engineering Contradiction:
Improveclosure precisionVSAvoiddelivery system complexity
Core Design Contradiction:
Manufacturing precisionVSDevice complexity

Solution Approach 1:

The patent combines multiple functions into the delivery catheter system: the catheter serves as both the delivery conduit and the anchoring mechanism. The suture-type tissue anchors are integrated with the catheter structure, allowing simultaneous deployment and anchoring without requiring separate complex devices, thus reducing overall system complexity while maintaining precision

Inventive Principle:
Principle #5Merging (Combining)

Data Source

PatentUS20240341744A1Minimally-invasive defect closure
Publication Date: 2024.10.17 EDWARDS LIFESCIENCES CORP
  • US20240341744A1 patent drawing
  • US20240341744A1 patent drawing
  • US20240341744A1 patent drawing

AI summary

Septal defect repair involves advancing an elongate shaft into an atrium of a heart of a patient through an outer atrial wall of the heart, contacting an atrial septum of the heart with a distal end of the elongate shaft, deploying a plurality of tissue anchors from the elongate shaft in tissue of the atrial septum, and cinching suture tails associated with the plurality of tissue anchors to at least partially close a defect in the atrial septum.