Surgical Stapler Sensing Anvil for Anastomotic Failure Prediction
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Solution Overview
Problem
Current surgical staplers lack the ability to predict and prevent anastomotic failures in gastrointestinal surgery due to the complex and patient-specific nature of biological tissue properties, which are disrupted during surgical procedures, leading to high morbidity and mortality rates and unnecessary additional procedures.
Innovation Solution
Integration of an array of multimodality sensors into surgical staplers to measure tissue oxygenation, perfusion, and interaction forces at multiple points around the staple joint, providing real-time feedback to the operative team to optimize anastomosis creation and potentially indicate the need for a diverting stoma or adjunct therapies.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If traditional surgical staplers are used without sensors, then the surgical procedure can be performed quickly and simply, but the ability to predict and prevent anastomotic failures is lost
Solution Approach 1:
The patent introduces sensors as intermediary components that mediate between the surgical stapler and the biological tissue. These sensors detect tissue properties (oxygenation, perfusion, mechanical properties) and provide information to the surgeon, enabling prediction of anastomotic success without requiring the surgeon to directly assess complex tissue characteristics. This intermediary system resolves the contradiction by adding sensing capability while maintaining relative simplicity through automated detection.
Solution Approach 2:
The patent replaces traditional mechanical assessment methods (visual inspection, manual palpation) with sensor-based detection systems. Instead of relying on the surgeon's mechanical senses to evaluate tissue viability, optical sensors, fluorescent sensors, and mechanical sensors automatically measure tissue properties. This substitution improves reliability by providing objective, quantifiable data while managing complexity through electronic measurement systems.
2Adaptability or versatility
If sensors are integrated into surgical staplers to detect tissue properties, then patient-specific characteristics can be accounted for, but the device complexity increases
Solution Approach 1:
The patent implements sensors with multiple sensing modalities (optical, fluorescent, mechanical) that can detect various tissue properties including oxygenation, perfusion, and mechanical characteristics. This multi-functional sensing system provides universal applicability across different patient-specific scenarios and tissue types, enabling adaptation to individual patient characteristics while consolidating multiple detection capabilities into a single integrated device.
Solution Approach 2:
The patent incorporates feedback mechanisms where sensor data is processed and used to provide real-time information about tissue viability and anastomotic success probability. The system measures tissue properties, compares them against predetermined criteria or machine learning models, and provides feedback to guide surgical decision-making. This feedback loop enables patient-specific adaptation by continuously monitoring tissue response and adjusting surgical approach based on objective measurements.
3Measurement precision
If multiple sensors are used to measure multiple tissue properties, then comprehensive tissue assessment is achieved, but the device complexity and cost increase
Solution Approach 1:
The patent divides the sensing function into multiple specialized sensor types, each optimized for detecting specific tissue properties. Optical sensors measure oxygenation and blood flow, fluorescent sensors detect perfusion and metabolic activity, and mechanical sensors assess tissue stiffness and compliance. This segmentation of sensing functions improves measurement precision for each specific property while allowing modular integration that manages overall device complexity through functional specialization.
Solution Approach 2:
The patent combines multiple sensing modalities (optical, fluorescent, mechanical) into a single integrated sensor array on the surgical stapler. Rather than using separate devices for each measurement type, the system merges these sensing capabilities into one unified platform that simultaneously or sequentially measures multiple tissue properties. This merging approach achieves comprehensive tissue assessment while managing complexity through integration and shared processing infrastructure.
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
Reduces anastomotic failures by enabling objective assessment of tissue viability before, during, and after anastomosis, minimizing patient morbidity and mortality, and reducing the need for additional procedures by providing patient-specific procedural guidance.
Implementation Method 1
The optical sensors are configured to measure at least one of tissue oxygenation, oxygen delivery, oxygen utilization
Implementation Method 2
The fluorescence based techniques include but are not limited to the following: monitoring and analyzing the intensity and time course of a fluorescent response responsive to the injection or activation of a fluorescent medium
Implementation Method 3
Mechanical sensing includes, but is not limited to, pressure sensors that monitor tissue interaction forces including compression pressure and tissue tension
Data Source
AI summary
A device and method in accordance with the invention for generating a signal indicative of a property of a subject tissue in contact with the working surface of a surgical instrument. The invention describes a sensing adjunct to surgical staplers. The adjunct can take the form of an optionally coupled accessory to a surgical stapler, or a stand-alone substitutive component acting to serve as a replacement for a component of the surgical stapler such as an anvil, housing or cartridge. Embodiments include a sensing anvil serving to act in place of a non-sensing surgical stapler anvil to monitor tissue properties of an anastomosis for the purpose of avoiding anastomotic failure.