Aortic Graft Occluder for Intraoperative Leak Testing

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Solution Overview

Problem

Current techniques for valve sparing root replacement in heart surgery lack a reliable method for verifying the correct fit and functionality of the heart valve and leak tightness of sutures during the procedure, requiring re-establishment of the circulatory system to confirm success, which can be stressful and risky for the patient.

Innovation Solution

An aortic graft occluder device that allows for intra-operative leak testing by sealingly closing a partially implanted aortic graft, pressurizing its interior, and using ultrasound to verify the valve's functionality and suture tightness, facilitating the identification of leaks and ensuring proper valve function.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If the circulatory system is re-established to verify valve functionality and suture tightness, then the functionality can be confirmed, but the patient is exposed to additional stress and surgical risks

Engineering Contradiction:
Improveverification of valve functionality and suture tightnessVSAvoidpatient stress and surgical risks
Core Design Contradiction:
ReliabilityVSObject-affected harmful factors

Solution Approach 1:

The patent applies preliminary action by enabling leak testing and valve functionality verification to be performed before re-establishing the circulatory system. The occluder device allows the surgical team to test the graft and valve while the aorta is still clamped, identifying and correcting any issues beforehand, thus avoiding the need to re-open sutures or perform additional corrections after circulation is restored

Inventive Principle:
Principle #10Preliminary action

2Reliability

If leak testing is performed before re-establishing circulation, then surgical errors can be identified early, but the aorta must remain clamped and the graft must be sealed

Engineering Contradiction:
Improveearly identification of surgical errorsVSAvoidneed for occluder device and clamping procedure
Core Design Contradiction:
ReliabilityVSDevice complexity

Solution Approach 1:

The occluder device serves as an intermediary element that temporarily seals the graft to enable leak testing. It acts as a mediator between the surgical team's need to test for leaks and the physiological requirement to eventually restore circulation, allowing controlled testing without permanent obstruction

Inventive Principle:
Principle #24Intermediary (Mediator)

3Reliability

If additional surgical corrections are performed after detecting leaks post-circulation restoration, then the leaks can be fixed, but the surgery time increases and patient risk increases

Engineering Contradiction:
Improvecorrection of surgical leaksVSAvoidadditional surgery time and patient exposure
Core Design Contradiction:
ReliabilityVSLoss of time

Solution Approach 1:

By performing leak testing before restoring circulation, the patent enables surgical errors to be identified and corrected during the initial surgical procedure. This preliminary verification prevents the need for additional corrective surgeries, thereby reducing total surgical time and minimizing patient exposure to surgical risks

Inventive Principle:
Principle #10Preliminary action

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

Enables efficient verification of aortic valve functionality and leak tightness during surgery, reducing the need for additional surgical corrections and minimizing patient risk by allowing for real-time assessment of valve closure efficiency and suture integrity.

Implementation Method 1

By filling the lumen of the graft with fluid, i.e. gas and/or liquid (e.g., saline) and by thereby pressurizing the interior of the graft

Methodology Applied
Scientific EffectFluid pressurization: Pressure Increase

Implementation Method 2

By simultaneously imaging the valve, e.g. by ultrasound, e.g. by applying a transesophageal ultrasound technique, the proper functionality (e.g., closing efficiency) of the valve may be verified during the surgery

Methodology Applied
Scientific EffectUltrasound: Ultrasound

Data Source

PatentUS11458006B2Aortic graft occluder
Publication Date: 2022.10.04 PMU INNOVATIONS GMBH
  • US11458006B2 patent drawing
  • US11458006B2 patent drawing
  • US11458006B2 patent drawing

AI summary

An aortic graft occluder for intraoperative leak testing of a tubular aortic graft attached to an aortic root. The aortic graft occluder includes a plug adapted for sealingly closing an opening of the aortic graft. The plug includes a first pathway adapted for connecting a lumen of the aortic graft with a feed line.