Circular Stapler Tissue Relaxation Monitoring for Staple Formation
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Solution Overview
Problem
Existing powered surgical stapling devices lack efficient methods to monitor and optimize tissue relaxation during stapling procedures, leading to potential tissue damage and staple malformation due to inadequate waiting times for tissue relaxation.
Innovation Solution
A circular stapling device equipped with a strain gauge assembly and software that calculates tissue relaxation percent using strain gauge data, alerting clinicians when optimal relaxation is achieved and initiating the stapling sequence automatically or upon a predetermined time, thereby optimizing tissue stapling.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If surgeons wait a specified period of time (e.g., fifteen seconds or more) for tissue relaxation, then tissue damage is reduced and staple formation is improved, but surgical procedure time is extended
Solution Approach 1:
The patent employs real-time feedback through strain gauge sensors that continuously monitor tissue relaxation status during clamping. The system provides feedback signals to the surgeon indicating when optimal relaxation has been achieved, eliminating the need for fixed waiting periods and enabling precise timing for staple firing that minimizes tissue damage while optimizing surgical efficiency.
Solution Approach 2:
The patent replaces the traditional mechanical timing approach (fixed waiting periods) with an electronic sensing and monitoring system. Strain gauge sensors detect tissue relaxation through electrical resistance changes, substituting mechanical time-based protocols with electronic measurement and control, thereby optimizing both tissue protection and surgical time management.
2Productivity
If surgeons wait insufficient time for tissue relaxation, then surgical procedure time is reduced, but tissue damage increases and staple malformation occurs
Solution Approach 1:
The strain gauge monitoring system provides real-time feedback on tissue relaxation status, enabling surgeons to fire staples at the precise moment when tissue has sufficiently relaxed. This feedback mechanism ensures high-quality staple formation while minimizing unnecessary waiting time, thereby optimizing both surgical efficiency and staple reliability.
Solution Approach 2:
The system performs preliminary monitoring of tissue relaxation status before staple firing is initiated. By continuously measuring strain gauge data during the clamping period, the system determines the optimal firing moment in advance, ensuring proper staple formation without requiring excessive waiting time and thus maintaining high surgical productivity.
3Ease of manufacture
If strain gauge electronics are made sterilizable or reprocessable for adapter assembly reuse, then device cost is reduced, but manufacturing complexity increases
Solution Approach 1:
The patent describes making the adapter assembly with integrated strain gauge electronics either sterilizable for reuse or designed as a disposable component. This approach simplifies the overall system by eliminating the need for complex sterilization infrastructure, allowing healthcare facilities to choose based on their capabilities while maintaining cost-effectiveness through standardized manufacturing processes.
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 device ensures minimal tissue damage and proper staple formation by determining when tissue has stabilized, allowing for informed decision-making and reducing procedural time.
Implementation Method 1
a strain gauge assembly, a reload assembly operably secured to the adapter assembly
Data Source
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AI summary
A circular stapling device includes a handle assembly including a processor, an adapter assembly including a trocar assembly and a strain gauge assembly, a reload assembly operably secured to the adapter assembly, the reload assembly including a staple cartridge, and an anvil assembly releasably secured to the trocar assembly and moveably positioned relative to the staple cartridge between a spaced position and a clamped position. The processor includes software for determining when tissue clamped between the staple cartridge and the anvil assembly has achieved a predetermined tissue relaxation percent. A method of optimizing tissue relaxation during a stapling procedure includes clamping tissue between an anvil assembly and a reload assembly, calculating a tissue relaxation percent of the clamped tissue, and initiating a stapling sequence when the tissue relaxation percent equals or is less than a predetermined tissue relaxation percent.