Flared Stent with Balloon for Anastomotic Leak Repair
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Solution Overview
Problem
Post-anastomosis surgery leaks, particularly in bariatric surgery, pose significant complications due to the risk of gastric leaks at the stapling sites, leading to increased morbidity and mortality, with existing treatments having drawbacks such as underreporting and ineffective healing.
Innovation Solution
A stent design featuring an elongated tube with flared ends and an inflatable balloon, coated with a polymeric material, is positioned to prevent leaks by physically isolating the stapling site, allowing for expansion to prevent migration and facilitate healing, and can be removed once the connection is secure.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If a stent is used to physically isolate the stapling site to prevent leaks, then the reliability of preventing gastric leaks is improved, but the device complexity increases due to the need for an inflatable balloon and polymeric coating
Solution Approach 1:
The stent is divided into functional segments: the elongated tube provides structural support, the polymeric coating creates a barrier layer, and the inflatable balloon provides adjustable sealing. This segmentation allows each component to address specific aspects of leak prevention independently.
Solution Approach 2:
The polymeric coating is applied in advance to the stent surface before implantation, creating a pre-formed barrier that immediately begins preventing leaks upon deployment. The balloon is designed to be inflated after positioning to ensure proper sealing.
2Stability of the object's composition
If an inflatable balloon is added to prevent stent migration, then the stability of stent positioning is improved, but the device complexity and ease of operation worsen due to additional inflation mechanisms
Solution Approach 1:
The balloon transitions from a deflated state during insertion to an inflated state after positioning. This dynamic transformation allows the stent to be easily inserted in a compact form and then stabilized in place once positioned correctly at the stapling site.
Solution Approach 2:
The inflation valve serves as an intermediary mechanism that controls the balloon's expansion. It allows selective inflation to achieve proper positioning stability while maintaining the ability to deflate and remove the stent when no longer needed.
3Duration of action of moving object
If the stent remains in place for an extended period to ensure healing, then the duration of protection against leaks is improved, but the loss of time for patient recovery and the need for eventual removal increases
Solution Approach 1:
The stent provides continuous protection throughout the healing process without requiring additional interventions. The inflatable balloon maintains constant sealing pressure, and the polymeric coating provides ongoing barrier protection, allowing the tissue to heal autonomously.
Solution Approach 2:
The stent is designed as a temporary device that is removed after serving its protective function. Once healing is complete, the balloon can be deflated and the stent extracted, allowing the patient to return to normal function without long-term device retention.
4Reliability
If the elongated tube with flared ends is used to isolate the stapling site, then the effectiveness of leak prevention is improved, but the manufacturing precision requirements increase due to the flared geometry and coating application
Solution Approach 1:
The flared ends are specifically designed to provide radial expansion for sealing against the tissue walls at the insertion and distal sites. The polymeric coating is applied to specific regions where contact with tissue occurs, providing localized barrier protection where it is most needed rather than uniformly across the entire stent.
Data Source
AI summary
A stent for repairing post-anastomosis surgery leaks is described. The stent includes an elongated tube having a flared proximal end and a flared distal end, and an intermediate region disposed between those two ends. An inflatable balloon is disposed about the intermediate region. In addition, the elongated tube is coated with a coating.