Pledgeted Mattress Suture for Atrial Appendage Closure

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Solution Overview

Problem

Current methods for treating atrial fibrillation, such as manual suturing and catheter-based approaches, are invasive, cause tissue trauma, and increase the risk of thromboembolism due to foreign material exposure, and are not effective in minimizing the size of the atrial appendage during beating heart procedures.

Innovation Solution

A less invasive method using a pledgeted mattress suture stitch with deformable or superelastic needles and reinforced pledgets to compress and isolate the atrial appendage, distributing stress over a larger tissue surface, thereby reducing the risk of thromboembolism and allowing for efficient closure without the need for cardiopulmonary bypass.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If manual suturing is used to close the atrial appendage, then the closure can be achieved, but the procedure requires cardiopulmonary bypass support and causes significant tissue trauma

Engineering Contradiction:

Improveclosure reliabilityVSAvoidtissue trauma

Core Design Contradiction:

ReliabilityVSObject-affected harmful factors

Solution Approach 1:

The patent introduces a pledget as an intermediary element between the suture and the tissue. The pledget distributes the suture tension over a larger tissue surface area, preventing tissue cutting and reducing trauma while maintaining reliable closure of the atrial appendage

Inventive Principle:

Principle #24Intermediary (Mediator)

Solution Approach 2:

The patent replaces the traditional mechanical manual suturing system with a self-contained suture delivery device that uses a curved needle and pusher mechanism to advance the pledgeted suture through the tissue, eliminating the need for cardiopulmonary bypass and reducing procedural complexity

Inventive Principle:

Principle #28Mechanics substitution (Replace mechanical system)

2Reliability

If catheter-based patch approaches are used to occlude the atrial appendage, then occlusion can be achieved, but foreign material exposure increases the risk of thromboembolism

Engineering Contradiction:

Improveocclusion effectivenessVSAvoidthromboembolism risk

Core Design Contradiction:

ReliabilityVSObject-generated harmful factors

Solution Approach 1:

The patent extracts and eliminates the foreign patch material from the solution. Instead of placing a patch over the atrial appendage ostium, the invention uses a pledgeted suture to directly close the opening from the inside, removing the thromboembolic risk associated with foreign material exposure to blood flow

Inventive Principle:

Principle #2Taking out (Extraction)

Solution Approach 2:

The pledget material is selected to be biocompatible and similar in characteristics to the surrounding tissue, reducing the foreign body response and thromboembolic risk while maintaining effective closure

Inventive Principle:

Principle #33Homogeneity

3Ease of manufacture

If simple suture placement is used to close the atrial appendage, then the procedure is simple, but the suture can cut into the tissue at the turning point

Engineering Contradiction:

Improveprocedure simplicityVSAvoidtissue holding strength

Core Design Contradiction:

Ease of manufactureVSStrength

Solution Approach 1:

The patent applies beforehand cushioning by placing the pledget at the suture turning point before tightening the suture. The pledget acts as a cushion that distributes the compressive force, preventing the suture from cutting into the tissue while maintaining closure effectiveness

Inventive Principle:

Principle #11Beforehand cushioning (Prior cushioning)

Applied Scientific Principles

This section explains which scientific principles are used to turn an abstract innovation direction into a practical engineering solution.

Function Achieved in This Case

This approach enables reliable and consistent closure of the atrial appendage orifice, reducing the risk of thromboembolic events, minimizing tissue trauma, and allowing for less invasive procedures with shorter recovery times and reduced pain.

Implementation Method 1

deformable or superelastic needles, and suture (one, two, or multiple strands) are passed through the atrial appendage

Methodology Applied

Scientific EffectSuperelasticity: Pseudoelasticity

Data Source

PatentUS7931578B2Methods and system for tissue cavity closure

Publication Date: 2011.04.26 ATRICURE INC

AI summary

Surgical systems for less invasive access to and isolation of an atrial appendage are provided. A suturing grasper compresses soft tissue structures and deploys one or more sutures through complimentary pledget(s) carried by the grasper. The pledgets are reinforced, containing support members that define the profile of the stitch and distribute stresses applied by the stitch, once tightened, over a length of tissue. This hardware may be applicable to other surgical and catheter based applications as well including: compressing soft tissue structures lung resections and volume reductions; gastric procedures associated with reduction in volume, aneurysm repair, vessel ligation, or other procedure involving isolation of, resection of, and reduction of anatomic structures.