Amnion-Covered Surgical Stapler Cartridge for Anastomotic Leak Reduction
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Solution Overview
Problem
Current surgical stapler devices and methods are prone to complications such as leakage, inflammation, and rupture during gastrointestinal anastomosis procedures, with anastomotic leaks occurring at a rate of up to 20%.
Innovation Solution
A cartridge for a surgical stapler is designed with an anvil leg and a staple leg, where the staple leg includes a plurality of staples and an inwardly facing surface with openings for the staples to pass through. A cover device with at least one sheet of amnion is attached to the inner surface of the anvil or staple leg, which transfers to the tissue during the stapling procedure to enhance the security of the tissue connection.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If conventional surgical staplers are used for gastrointestinal anastomosis, then the surgical procedure can be performed, but the incidence of anastomotic leaks reaches up to 20%
Solution Approach 1:
The patent introduces an amnion membrane as an intermediary layer between the staples and the tissue. This membrane is attached to the inwardly facing surface of the staple leg and transfers to the tissue during stapling, serving as a mediator that enhances the seal and reduces leaks at the anastomotic site.
Solution Approach 2:
The patent combines the amnion membrane with the metallic staple structure to create a composite fastening system. The amnion membrane provides biological compatibility and sealing properties, while the staple provides mechanical fastening, creating a composite structure that addresses both mechanical strength and biological integration needs.
2Strength
If surgical staplers deploy multiple staples for tissue connection, then the connection strength is improved, but complications such as leakage, inflammation, and rupture still occur
Solution Approach 1:
The patent changes the physical and chemical parameters of the tissue-staple interface by introducing the amnion membrane. This membrane modifies the interaction between staples and tissue, reducing mechanical stress concentration and providing a more compliant interface that reduces inflammation and rupture risks while maintaining connection strength.
3Reliability
If a cover device with amnion sheet is added to the surgical stapler, then the security of tissue connection is enhanced, but the device complexity increases
Solution Approach 1:
The patent merges the cover device with the staple leg structure by attaching the amnion membrane directly to the inwardly facing surface of the staple leg. This integration combines the fastening function of the staple with the protective and sealing functions of the amnion membrane into a single unified component, reducing the number of separate parts.
Solution Approach 2:
The amnion membrane serves multiple functions simultaneously: it acts as a protective barrier, a sealing layer to prevent leaks, and a biocompatible interface that reduces inflammation. This multi-functionality consolidates several protective roles into a single component, offsetting the added complexity with functional efficiency.
Data Source
AI summary
A cartridge configured to be connected to a surgical stapler includes an anvil leg having an inwardly facing surface and a staple leg pivotally connected to the anvil leg. The staple leg includes a plurality of staples and an inwardly facing surface configured to move towards the inwardly facing surface of the anvil leg. The inwardly facing surface of the staple leg includes a plurality of openings positioned for the plurality of staples to pass through the plurality of openings to tissue positioned between the anvil leg and the staple leg. The cartridge also includes a cover device having at least one sheet of amnion attached to the inner surface of at least one of the anvil leg or the staple leg configured to attach to the tissue positioned between the inwardly facing surface of the anvil leg and the inwardly facing surface of the staple leg.