Circular Stapler Anvil Isolating Sleeve for Anastomotic Leakage
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Solution Overview
Problem
Current surgical stapling technologies face challenges in effectively isolating and reinforcing anastomotic joints, leading to post-operative leakage and tissue infection, particularly due to difficulties in accessing and applying therapeutic agents to the stapled tissue sites, especially in deep pelvic locations.
Innovation Solution
The use of tubular polymeric sleeves, optionally impregnated with medicants, which are stapled to the anastomotic joint during surgery and left in place to create an isolating enclosure, providing reinforcement and localized release of therapeutic agents to prevent leakage and infection.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If surgical staples are used to join tissue, then tissue joining is achieved, but isolation and reinforcement of the anastomotic joint are insufficient leading to leakage and infection
Solution Approach 1:
The isolating sleeve is stored within the anvil assembly during surgery and deployed after stapling, creating a nested configuration where the protective sleeve is contained within the surgical instrument until needed. This allows the sleeve to be delivered through the same surgical access without requiring separate procedures.
Solution Approach 2:
The isolating sleeve is pre-positioned on the anvil assembly before the stapling procedure begins. The medicants are pre-loaded into the sleeve, and the entire assembly is prepared in advance, allowing for immediate deployment after stapling without requiring separate application steps during surgery.
2Reliability
If therapeutic agents are applied to stapled tissue sites, then tissue reinforcement is improved, but accessibility to deep pelvic locations makes application difficult
Solution Approach 1:
The isolating sleeve and medicant delivery system are merged into a single integrated component that is attached to the anvil assembly. This combines the functions of isolation and therapeutic delivery into one device that can be applied through the same surgical access route as the stapler itself, eliminating the need for separate application procedures.
Solution Approach 2:
The anvil assembly serves as an intermediary carrier that transports the isolating sleeve and medicants to the surgical site. The sleeve is attached to the anvil, which is already positioned at the target location during stapling, providing a convenient delivery mechanism that overcomes the accessibility problems of deep pelvic locations.
3Reliability
If isolating sleeves are deployed after stapling, then anastomotic joint isolation is achieved, but device complexity increases
Solution Approach 1:
The anvil assembly is designed to serve multiple functions: it forms the staples during stapling, carries the isolating sleeve, and facilitates its deployment. This multi-functionality eliminates the need for separate isolation devices and reduces overall system complexity despite adding isolation capabilities.
Solution Approach 2:
The isolating sleeve is designed as a separate, removable component that can be extracted from the anvil assembly after deployment. This modular approach allows the sleeve to be independently manufactured and sterilized, and simplifies the overall device structure by separating the isolation function from the stapling mechanism.
Data Source
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AI summary
The present invention relates to surgical instruments and methods for enhancing properties of tissue repaired or joined by surgical staples and, more particularly to surgical instruments and methods designed to enhance the properties of repaired or adjoined tissue at a target surgical site, especially when sealing an anastomosis between adjacent intestinal sections so as to improve tissue viability, prevent tissue infection, and to prevent leakage. The present invention further relates to circular stapling instruments and elongated tubular hollow sleeves deployed from such stapling instruments and establishing an enclosure around the stapled and resected tissues at the anastomotic joint.