Surgical Stapler Clamping Pressure Control for Variable Tissue Thickness
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Solution Overview
Problem
Existing surgical stapling instruments struggle to apply a consistent clamping pressure to tissue regardless of its thickness, leading to issues such as blood leakage or tissue necrosis due to over or under compression during staple formation.
Innovation Solution
A surgical stapling instrument that measures and controls clamping pressure within a predetermined range by adjusting the anvil and cartridge assemblies to ensure proper staple formation, using a strain gauge and controller to manage tissue compression forces, preventing staple firing outside this range.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Manufacturing precision
If the anvil and staple cartridge are moved to a predetermined tissue gap position, then the stapling instrument can form staples, but the clamping pressure varies greatly depending on tissue thickness leading to blood leakage or tissue necrosis
Solution Approach 1:
The stapling instrument includes a sensor that detects the actual tissue gap between the anvil and staple cartridge during the clamping process. The controller receives this sensor data and adjusts the clamping force accordingly to maintain a target tissue gap, ensuring consistent clamping pressure regardless of tissue thickness variations. This feedback mechanism prevents both under-compression (blood leakage) and over-compression (tissue necrosis).
Solution Approach 2:
The system transitions from a static predetermined tissue gap approach to a dynamic adjustment mechanism. The controller actively modifies the clamping force based on real-time sensor feedback about the actual tissue gap, allowing the system to adapt to varying tissue thickness while maintaining optimal stapling conditions.
2Ease of operation
If the anvil assembly is advanced to define a tissue gap within a predetermined range, then staple formation is enabled, but the clamping pressure may still be outside the acceptable range due to tissue thickness variations
Solution Approach 1:
The sensor continuously monitors the tissue gap during anvil advancement and provides real-time data to the controller. The controller uses this feedback to determine when the tissue gap is within the predetermined range and to adjust clamping force to ensure the pressure is within the acceptable range, enabling reliable staple firing only when conditions are optimal.
Solution Approach 2:
The system replaces purely mechanical predetermined gap settings with a sensor-based detection and controller-based adjustment system. This substitution allows for more precise control of clamping pressure by using electronic sensing and control rather than relying solely on mechanical positioning.
3Adaptability or versatility
If a universal stapler design is implemented to reduce inventory needs, then operational efficiencies improve, but the ability to handle different tissue thicknesses consistently becomes more challenging
Solution Approach 1:
The stapling instrument is designed as a universal device that can handle various tissue types and thicknesses through its sensor-based feedback control system. The single device incorporates adjustable clamping force mechanisms that adapt to different tissue characteristics, eliminating the need for multiple specialized staplers while maintaining consistent clamping pressure across different applications.
Solution Approach 2:
The system changes the clamping force parameter dynamically based on sensor feedback about the actual tissue gap. This parameter adjustment capability allows the universal stapler to maintain optimal clamping pressure across different tissue thicknesses, resolving the contradiction between universality and precision control.
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
Ensures consistent staple formation by adjusting to tissue thickness, reducing the risk of blood leakage or necrosis, and allowing for a universal stapler design that reduces inventory needs and operational efficiencies.
Implementation Method 1
measuring a first force of tissue compression of the tissue clamped within the first tissue gap with the anvil assembly in the first position
Data Source
AI summary
A surgical stapling instrument includes an anvil assembly, a reload assembly, an adapter assembly, a processor, and a memory. When clamping to a target pressure, the instructions cause the surgical stapling instrument to advance the anvil assembly in relation to a staple cartridge supported on the reload assembly to a first position to define a first tissue gap within a predetermined acceptable range of tissue gaps, measure a first force of tissue compression of tissue clamped within the first tissue gap with the anvil assembly in the first position, and enter a firing mode of the surgical stapling instrument if the first force of tissue compression is within a predetermined acceptable range of tissue compression.