Expandable Compression Rings for Anastomotic Leakage Prevention
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Solution Overview
Problem
Post-operative leakage of stapled tissue seals, particularly anastomotic seals, leads to morbidity and mortality, and existing technologies face challenges in reliably applying sealants to the correct site due to limited access and difficulty in visual assessment during colorectal anastomoses.
Innovation Solution
A circular surgical stapler with a stapling head and an opposing anvil, combined with a compression device featuring inflatable ring-shaped flanges that are deployed over the stapled area to reinforce and isolate the tissue, providing additional sealing and preventing leakage, while optionally releasing antimicrobial agents.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Productivity
If surgical staples are used to join tissue, then the joining speed and efficiency are improved, but the reliability of the seal against leakage deteriorates
Solution Approach 1:
The patent combines stapling and sealing functions into a single integrated device. The compression ring is deployed simultaneously with the staples by the same circular stapler, merging two separate operations (stapling and sealant application) into one unified action, thereby maintaining high productivity while improving seal reliability.
Solution Approach 2:
The compression ring is deployed in advance before the stapling process completes. The ring is positioned around the anastomosis site and expanded to deliver sealant prior to or during staple formation, preparing the tissue surface beforehand to prevent leakage from the outset rather than addressing it afterward.
2Reliability
If sealants are applied to the surgical site, then the sealing effectiveness is improved, but the ease of operation deteriorates due to limited access and difficulty in visual assessment
Solution Approach 1:
The compression ring device is self-contained with the sealant already loaded within its structure. The device automatically positions and deploys the sealant at the correct location through its own mechanical expansion, eliminating the need for separate manual sealant application steps and reducing dependence on surgeon skill and visual assessment.
Solution Approach 2:
The compression ring acts as an intermediary carrier that bridges the gap between the stapler and the tissue surface. It delivers the sealant directly to the anastomosis site through controlled expansion, mediating the sealing process in a way that is independent of difficult visual conditions and limited surgical access.
3Reliability
If a compression device with inflatable flanges is deployed, then the sealing and isolation of stapled areas is improved, but the device complexity increases
Solution Approach 1:
The compression ring serves multiple functions within a single structural element: it provides mechanical compression of the tissue, delivers sealant to the anastomosis site, and creates isolation of the stapled area. This multi-functionality reduces the need for separate devices while maintaining improved sealing and isolation reliability.
Solution Approach 2:
The inflatable flanges are constructed from flexible materials that can expand and conform to the tissue geometry. This flexibility allows the device to adapt to different anatomical shapes without requiring complex rigid structures, simplifying the overall device design while maintaining effective sealing and isolation capabilities.
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
The solution enhances tissue viability by preventing leakage and infection, improving the reliability of stapled anastomotic joins by providing enhanced sealing and isolation of the stapled areas, even in challenging anatomical locations like the pelvic canal.
Implementation Method 1
The shaft includes conduits for communicating a pressurized medium to the inflatable members
Implementation Method 2
The at least one inflatable member is configured to provide a seal of at least one of the one or more lumens, wherein the seal is adjacent the anastomosis, wherein the seal is provided upon inflation of the at least one inflatable member
Data Source
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 an expandable compression device for application to anastomotically joined tubular tissues, comprising: an upper ring-shaped or disk-shaped flange at a distal end of said device connected to a lower ring-shaped inflatable flange at a proximal end of said device via a hollow cylindrical tubular body, with an opening forming an axial passage through said upper flange, lower flange, and tubular body.