Anastomotic Stapling Reinforcing Buttress Deployment
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Solution Overview
Problem
Post-operative leakage of stapled tissue seals, including anastomotic seals, leads to morbidity and mortality, and existing technologies face challenges in reliably applying therapeutic agents to the serosal layer due to limited access and difficulty in visual assessment, especially in colorectal anastomoses performed low in the pelvic canal.
Innovation Solution
A circular surgical stapler with a reinforcing buttress and deployment tool that attaches the buttress to the stapler using radial slits and triangular flaps, allowing for secure deployment and integration with the stapler head, enhancing tissue viability and preventing leakage by providing a biological effect at the anastomotic site.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Productivity
If surgical staples are used to join tissue, then the joining process is faster and more consistent than suturing, but the reliability of the seal against leakage is insufficient
Solution Approach 1:
The patent combines surgical staples with a biological buttress material to create a composite joining system. The buttress material is integrated with the stapler device and deployed simultaneously with the staples, merging two separate functions (mechanical fastening and sealing reinforcement) into a single unified system that addresses both productivity and reliability concerns.
Solution Approach 2:
The invention uses composite construction by combining metallic surgical staples with biological buttress material (such as collagen or other biocompatible substances). This composite approach allows the staples to provide immediate mechanical strength and alignment, while the biological material provides enhanced sealing properties and promotes tissue healing, thereby improving overall seal reliability without sacrificing joining speed.
2Reliability
If sealants are applied to the outer surface of the anastomosis, then leakage protection is improved, but the complexity of the surgical procedure increases due to separate application steps
Solution Approach 1:
The biological buttress material is integrated directly onto the stapler device (either on the anvil or cartridge), combining the sealing function with the stapling mechanism. This integration eliminates the need for separate sealant application steps, as the buttress is deployed automatically when the stapler is activated, thereby maintaining high leakage protection while reducing procedural complexity.
Solution Approach 2:
The buttress material is pre-positioned on the stapler device before the surgical procedure begins. This preliminary preparation allows the sealing function to be automatically activated during the stapling process itself, eliminating the need for subsequent separate application steps and reducing overall procedure complexity while maintaining reliable leakage protection.
3Reliability
If a buttress material is attached to the stapler, then tissue viability and sealing are improved, but the difficulty of deploying the buttress correctly increases
Solution Approach 1:
The buttress material is permanently or semi-permanently attached to the stapler device components (anvil or cartridge), merging the deployment mechanisms. This integration ensures that when the stapler is activated, the buttress is automatically deployed in the correct position and orientation, eliminating the need for separate manual attachment steps and reducing deployment difficulty while maintaining improved tissue viability and sealing.
Solution Approach 2:
The integrated buttress system is designed to self-deploy automatically when the stapler is activated. The mechanical action of firing the stapler inherently triggers the release and deployment of the buttress material into the correct position, eliminating the need for additional manual manipulation or adjustment by the surgeon, thereby simplifying the deployment process while ensuring reliable tissue viability enhancement.
Data Source
Figure 1~2B
Figure 3A~3B
Figure 4A~5D
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.