Surgical Stapler Suture Failure Detection via Force Monitoring

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Solution Overview

Problem

Current surgical stapling instruments lack the ability to effectively detect purse-string suture failure during tissue clamping, which can lead to incomplete or failed anastomosis procedures, resulting in potential tissue leakage.

Innovation Solution

A computer-implemented method and surgical stapling instrument that measures tissue compression forces using a strain gauge to determine if a purse-string suture has failed by comparing initial and subsequent compression forces, and prevents staple firing if failure is detected, while also providing visual and auditory warnings to the surgeon.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If a purse-string suture is used during surgical stapling to enhance anastomosis integrity, then the reliability of the anastomosis is improved, but the risk of suture failure during clamping increases

Engineering Contradiction:

Improveanastomosis integrityVSAvoidsuture failure risk

Core Design Contradiction:

ReliabilityVSObject-affected harmful factors

Solution Approach 1:

The system continuously monitors tissue compression forces during clamping and provides real-time feedback about suture integrity. When the suture fails, the system detects the force change and alerts the surgeon, enabling immediate corrective action to maintain anastomosis reliability.

Inventive Principle:

Principle #23Feedback

Solution Approach 2:

The system performs preliminary detection of suture integrity during the clamping process before staple firing occurs. By measuring compression forces at different stages of clamping, the system identifies suture failure early, preventing potential leakage before it compromises the anastomosis.

Inventive Principle:

Principle #10Preliminary action

2Reliability

If real-time suture failure detection is implemented during tissue clamping, then the reliability of anastomosis is improved, but the device complexity increases

Engineering Contradiction:

Improvesuture failure detectionVSAvoidinstrument complexity

Core Design Contradiction:

ReliabilityVSDevice complexity

Solution Approach 1:

The system replaces complex mechanical sensing mechanisms with electrical force sensors that measure tissue compression forces. This substitution provides accurate suture failure detection while keeping the device structure relatively simple and integrated within the existing stapling instrument.

Inventive Principle:

Principle #28Mechanics substitution (Replace mechanical system)

Solution Approach 2:

The force sensing capability serves multiple functions: it monitors tissue clamping force, detects suture integrity, and prevents staple firing when suture failure is detected. This multi-functionality reduces the need for separate detection systems, thereby limiting the increase in device complexity.

Inventive Principle:

Principle #6Universality (Multi-functionality)

3Measurement precision

If multiple force measurements are taken during clamping to detect suture failure, then the measurement precision of suture integrity is improved, but the loss of time during surgery increases

Engineering Contradiction:

Improvesuture integrity detectionVSAvoidsurgical procedure time

Core Design Contradiction:

Measurement precisionVSLoss of time

Solution Approach 1:

The system continuously measures tissue compression forces throughout the clamping process rather than taking discrete separate measurements. This continuous monitoring detects suture failure immediately when it occurs, maintaining high measurement precision while minimizing surgical time loss through automated real-time detection.

Inventive Principle:

Principle #20Continuity of useful action

Solution Approach 2:

The system monitors changes in compression force parameters over time during clamping. By analyzing the temporal pattern of force changes and comparing measurements at different clamping stages, the system achieves precise suture integrity detection through parameter evolution rather than requiring multiple separate measurement events.

Inventive Principle:

Principle #35Parameter changes

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 solution ensures proper tissue clamping and prevents staple firing when suture failure is detected, thereby enhancing the integrity of the anastomosis and reducing the risk of leakage by accurately determining suture integrity in real-time.

Implementation Method 1

measuring a first force of tissue compression of the tissue clamped within the tissue gap with the anvil assembly at a first time point

Methodology Applied

Scientific EffectStrain gauge measurement: Piezoresistive Effect

Data Source

PatentUS12048434B2Systems and methods for suture failure detection during surgical stapling

Publication Date: 2024.07.30 COVIDIEN LP

AI summary

A computer-implemented method for controlling a surgical stapling instrument for stapling tissue includes advancing an anvil assembly in relation to a staple cartridge to a first position defining a tissue gap between the staple cartridge and the anvil assembly and clamping tissue, the clamped tissue including a suture, measuring a first force of tissue compression of the tissue clamped within the tissue gap with the anvil assembly at a first time point, determining whether the measured first force is greater than a threshold, measuring a second force of tissue compression of the tissue clamped within the tissue gap at a second time point in response to the determination that the first force is greater than the threshold, determining whether the suture failed based on the measured second force being an amount less than the measured first force, and stopping the advancing of the anvil assembly based on the determined suture failure.