Surgical Stapler Jaw Barrier for No-Cut Tissue Migration Control
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Solution Overview
Problem
Surgical staplers used in bariatric surgery, such as the TITAN ®< SGS23R, face issues with tissue migration between the jaws during closure, leading to potential transection of unstapled tissue and post-operative complications like leaks, due to the absence of effective barriers in the open position.
Innovation Solution
Implementing a system with a no tissue zone defined by proximal and distal tissue stops and a warning, blocking, or barrier forming device, including flexible sheaths, rigid shields, flexible bands, or mechanical mechanisms to prevent tissue migration and ensure stapled transection, and using software and sensors to detect and correct unwanted tissue presence.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If a surgical stapler is used without a barrier device in the open position, then the device structure remains simple, but tissue migration occurs between the jaws leading to transection of unstapled tissue
Solution Approach 1:
The barrier device is designed to be dynamic rather than static. It includes a biased position that allows it to move between blocking tissue migration when the jaws are open and retracting to permit tissue insertion when the jaws are closed. This dynamic behavior resolves the contradiction by providing reliable tissue protection only when needed, without permanently complicating the device structure.
Solution Approach 2:
The barrier device is segmented into multiple components including a barrier member, a link mechanism, and attachment points on the jaws. This segmentation allows each component to perform its specific function independently while collectively preventing tissue migration. The segmented design enables the barrier to be integrated into the existing stapler structure without requiring a completely complex new design.
2Reliability
If a barrier device is added to prevent tissue migration, then tissue protection is improved, but the ease of operation is reduced due to additional components
Solution Approach 1:
The barrier device is designed to be self-actuating through a biasing mechanism that automatically positions the barrier to block tissue migration when the jaws are in the open position. The barrier moves on its own without requiring manual intervention, thus maintaining ease of operation while providing reliable tissue protection. The self-service characteristic resolves the contradiction by eliminating the need for additional operational steps.
Solution Approach 2:
The barrier device performs preliminary action by pre-positioning itself to prevent tissue migration before the actual stapling operation begins. When the jaws are opened to position tissue, the barrier is already in place to block unwanted migration. This preliminary protective action occurs automatically without requiring the surgeon to take additional steps during the procedure.
3Reliability
If the barrier device blocks all tissue movement, then tissue migration is prevented, but the ability to insert and position tissue between jaws is hindered
Solution Approach 1:
The barrier device dynamically adjusts its position based on the state of the jaws. When jaws are closed and tissue is being inserted, the barrier retracts or moves to a position that permits tissue passage. When jaws are opened and tissue migration risk increases, the barrier moves into its blocking position. This dynamic adaptability resolves the contradiction by providing tissue protection only when needed without hindering tissue insertion.
Solution Approach 2:
The barrier device applies preliminary anti-action by positioning itself to counteract potential tissue migration before it can occur. However, this anti-action is selectively applied only when the jaws are in the open position where migration is a risk. When jaws are closed and tissue insertion is needed, the preliminary anti-action is temporarily suspended, allowing tissue to pass freely.
Data Source
Figure 1A
Figure 1B~2
Figure 3~4
AI summary
A system for preventing unwanted tissue migration in surgical staplers includes a surgical stapler having an end effector (100) including an upper jaw (120) and a lower jaw (140). A distal end of the upper jaw (120) is connected to a distal end of the lower jaw (140), and a proximal end of the upper jaw (120) is connected to a proximal end of the lower jaw (140). First and second tissue stops (152, 154) are formed on the distal and proximal ends of the lower jaw (140), respectively. The second tissue stop (154) and the proximal end of the upper jaw (120) define a no cut zone (160) when the surgical stapler is in an open position. The surgical stapler also includes a tissue cutting device (170) disposed within the lower jaw (140) for resecting tissue. The system also includes a warning, blocking, impeding, or barrier forming device (348, 350, 360, 362, 365, 372, 373, 380, 382, 383, 388, 390) for preventing the unwanted migration of tissue into the no tissue zone (160).