Cardiac Aperture Closure Suturing With Pledgets for Leak Resistance

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Solution Overview

Problem

Existing methods for closing cardiac apertures such as patent foramen ovale, atrial septal defect, left atrial appendage, and pseudoaneurysm are bulky, cause tissue erosion, and often result in leaks, making them ineffective for irregularly shaped defects.

Innovation Solution

A suturing device with a curved suture delivery tube and apposition catheter or pivoting arm is used to pass a suture through tissue, followed by a patch delivery device to secure a patch over the aperture using pre-placed suture wires, ensuring proper closure.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If oversized devices are used to close cardiac apertures, then closure effectiveness is improved, but device bulkiness increases and tissue erosion is caused

Engineering Contradiction:

Improveclosure effectivenessVSAvoidtissue erosion

Core Design Contradiction:

ReliabilityVSObject-affected harmful factors

Solution Approach 1:

The closure device is divided into multiple components: an occluding element with pledgets positioned on either side of the aperture, and a separate delivery system. The pledgets act as cushions that distribute pressure locally, allowing effective closure without requiring a single oversized device that would cause tissue erosion.

Inventive Principle:

Principle #1Segmentation

Solution Approach 2:

Pledgets are placed on either side of the cardiac aperture before the occluding element is positioned. These pledgets serve as pre-positioned cushions that protect the tissue from direct contact with the occluding element, preventing tissue erosion while maintaining closure effectiveness.

Inventive Principle:

Principle #11Beforehand cushioning (Prior cushioning)

2Reliability

If conventional occluders are used to close PFO, then closure is achieved in most patients, but the atrial septum cannot be reused for future access

Engineering Contradiction:

Improveclosure success rateVSAvoidfuture access capability

Core Design Contradiction:

ReliabilityVSAdaptability or versatility

Solution Approach 1:

The occluding element is designed to be confined specifically to the PFO aperture with pledgets positioned only on either side of the defect. This localized approach preserves the surrounding atrial septum tissue, maintaining its integrity for potential future access while achieving reliable PFO closure.

Inventive Principle:

Principle #3Local quality

3Reliability

If existing closure methods are used for irregularly shaped defects, then some closure is achieved, but leaks occur and closure effectiveness is reduced

Engineering Contradiction:

Improveclosure effectivenessVSAvoidclosure precision

Core Design Contradiction:

ReliabilityVSManufacturing precision

Solution Approach 1:

The device allows for asymmetric positioning of pledgets and the occluding element to match the specific geometry of irregular apertures. This customized local configuration ensures complete tissue coverage and eliminates leaks, achieving precise closure tailored to each patient's anatomical variation.

Inventive Principle:

Principle #3Local quality

Data Source

PatentUS12544076B2Method and system for closure of cardiovascular apertures

Publication Date: 2026.02.10 AMX TECHNOLOGIES LLC

AI summary

Methods and devices for closing tissue apertures in a patient, such as PFO, are disclosed. A suturing device is used to place a suture through areas of tissue that are intended to be closed. Pledgets or buttons can be placed on the suture and each side of the tissue to help maintain the closure.