Non-destructive Air Leak Testing for Bioresorbable Surgical Conduits
Find Innovative SolutionsGenerate Solutions
Solution Overview
Problem
Current methods for leak testing surgical conduits, particularly valved conduits, are often destructive and require exposure to fluids like water or saline, which can compromise the sealing properties of bioresorbable materials such as gelatin or collagen, leading to unacceptable leakage rates and limitations in repeat testing.
Innovation Solution
A non-destructive leak testing method using air as the testing medium, where the conduit is clamped at both ends and pressurized with air, allowing for mass air-flow testing or pressure decay measurement to assess leakage, without requiring fluid exposure or drying post-test, thus preserving the bioresorbable materials and enabling 100% inspection and repeated testing.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Measurement precision
If water or saline is used for leak testing, then leakage detection is achieved, but the bioresorbable sealing medium is compromised and leakage rates increase
Solution Approach 1:
The patent uses air as the testing medium instead of water or saline. Air is inert to the bioresorbable sealing medium (gelatin or collagen), preventing degradation while still enabling effective leak detection through pressure decay measurement or mass air-flow testing.
Solution Approach 2:
The patent applies pneumatic testing by introducing pressurized air into the conduit and measuring either the pressure decay over time or the mass air-flow rate. This pneumatic approach replaces hydraulic (water-based) testing, avoiding fluid exposure that would compromise the sealing medium.
2Measurement precision
If fluid-based leak testing is performed, then leaks are detected, but the conduit requires drying post-test which adds time and complexity
Solution Approach 1:
By using air as the test medium, the patent eliminates the need for post-test drying operations. Air naturally evaporates or dissipates without leaving residue, and the conduit requires no drying time before storage or implantation, unlike water-based testing which would require thorough drying to prevent infection or material degradation.
Solution Approach 2:
The patent extracts the harmful element (water/saline) from the testing process and replaces it with a benign alternative (air). This extraction of the problematic fluid eliminates the entire drying step from the testing workflow, reducing time and simplifying the process.
3Reliability
If 100% inspection with repeat testing is required, then quality control is improved, but destructive testing methods prevent retesting
Solution Approach 1:
The use of air as the test medium enables non-destructive testing. Since air does not degrade the bioresorbable sealing medium or the conduit materials, the same conduit can be tested multiple times during manufacturing and quality control processes, allowing for 100% inspection and repeat testing without compromising the product integrity.
Solution Approach 2:
The patent performs leak testing at an early stage in the manufacturing process using air, before final assembly or sterilization. This preliminary non-destructive testing allows for early quality control and enables subsequent retesting if needed, whereas traditional water-based testing would be destructive and prevent further evaluation.
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 method effectively identifies leaks in surgical conduits while preserving the bioresorbable materials, allowing for 100% inspection and repeated testing without damaging the conduits, ensuring long-term viability and efficacy of the valved conduits by avoiding the degradation caused by fluid exposure.
Implementation Method 1
introducing a pressurised gas, such as air, to a predetermined pressure within a lumen of the conduit
Implementation Method 2
measuring a mass air-flow rate through the conduit with a mass flow meter
Implementation Method 3
measuring the pressure decay as air leaks from the conduit
Data Source
Figure 1~2
Figure 3~4B
Figure 5~5A
AI summary
Systems, devices, and methods for leak testing surgical conduit grafts or valved conduits such as aortic-valved conduits with a pressurized gas such as air. Air is nondestructive and especially useful for leak testing conduits that have coatings or sealants that may be functionally impacted when exposed to fluids such as water or saline. Open ends of the conduit are clamped and sealed, and a pressurized gas introduced into an inner lumen thereof. A change in mass flow rate is measured to quantify the leakage. One end of a tubular conduit may be clamped to a fixed manifold, and the opposite end to a manifold slidably mounted to accommodate any conduit elongation when pressurized. The clamping and sealing structure may be pneumatic and/or mechanical, and complementary contoured clamp members may be used to seal a scalloped external sealing ring of an aortic conduit.