Surgical Stapler Jaw Barriers for No Tissue Zone Protection
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Solution Overview
Problem
Existing surgical staplers used in bariatric surgery, such as the TITAN ®< SGS23R, suffer from unwanted tissue migration into the no tissue zone between the proximal tissue stop and the upper jaw, leading to potential transection of unstapled tissue and post-operative complications like leaks.
Innovation Solution
Implementations include structural and mechanical systems like flexible sheaths, rigid shields, and software-driven mechanisms to prevent tissue migration by blocking or warning the user of the no tissue zone, or reversing the cutting device before it reaches the unstapled tissue.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Ease of operation
If the surgical stapler uses a hinge connection between upper and lower jaws to enable opening and closing motion, then the stapler can perform stapling and cutting operations, but tissue migrates into the hinged region causing unwanted transection of unstapled tissue
Solution Approach 1:
A tissue stop is introduced as an intermediary component between the upper and lower jaws at the hinged region. This tissue stop acts as a barrier that prevents tissue from migrating into the hinged area while still allowing the jaws to open and close for stapling operations. The tissue stop is positioned to block the harmful tissue migration path without interfering with the necessary mechanical motion of the jaw system.
2Object-affected harmful factors
If the tissue stop is positioned close to the hinge to maximize protection against tissue migration, then tissue migration is prevented, but the cutting device may inadvertently cut tissue in the no tissue zone
Solution Approach 1:
The protective barrier is segmented into multiple functional zones: a tissue stop positioned at the hinged region to prevent tissue migration, and a no tissue zone defined by the tissue stop and proximal end of the upper jaw. The cutting device is controlled to operate only in designated safe zones, separating the cutting function from the protected no tissue zone. This segmentation allows the tissue stop to be positioned close to the hinge for maximum protection while the cutting device operates in controlled areas where it cannot inadvertently cut tissue.
3Reliability
If the no tissue zone is strictly enforced to prevent cutting of unstapled tissue, then surgical safety is improved, but the device complexity increases due to additional warning and blocking mechanisms
Solution Approach 1:
The stapler system incorporates self-service safety features including a tissue stop that passively prevents tissue migration through its physical positioning, and a control system that automatically prevents cutting in the no tissue zone without requiring active user intervention. The system monitors its own state and takes corrective action when tissue is detected in the no tissue zone, reducing the need for complex external warning and blocking mechanisms while maintaining high surgical safety standards.
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).