Surgical Stapler Compression Sensing for Reliable Staple Formation

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Solution Overview

Problem

Existing surgical stapling instruments lack the ability to distinguish between effective staple formations that prevent leaks and insufficient staple formations, which can lead to gastrointestinal tract contents leaking into the abdominal or thoracic cavity during anastomosis procedures.

Innovation Solution

A surgical stapling instrument equipped with a strain gauge and a controller that measures staple compression force, determining if it falls within a predetermined range, and adjusts operations accordingly to ensure proper staple formation, including entering a tissue cutting mode, preventing staple firing, displaying warnings, or retracting the pusher when compression exceeds the range.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If a surgical stapling instrument performs stapling without measuring staple compression force, then the device complexity is reduced, but the reliability of staple formation is compromised

Engineering Contradiction:
Improvestaple formation reliabilityVSAvoiddevice complexity
Core Design Contradiction:
ReliabilityVSDevice complexity

Solution Approach 1:

The patent replaces complex mechanical measurement systems with electrical sensing elements (strain gauges) to measure staple compression force. This substitution enables reliable detection of staple formation quality while keeping the device architecture manageable through electronic sensing rather than mechanical complexity.

Inventive Principle:
Principle #28Mechanics substitution (Replace mechanical system)

Solution Approach 2:

The control circuit receives signals from strain gauges measuring staple compression force and uses this feedback to determine whether staple formation is adequate. This feedback mechanism enables real-time quality assessment of staple formation, allowing the system to distinguish between effective and insufficient staple formations reliably.

Inventive Principle:
Principle #23Feedback

2Manufacturing precision

If the surgical stapling instrument measures staple compression force and controls staple firing, then the manufacturing precision of staple formation is improved, but the device complexity increases

Engineering Contradiction:
Improvestaple formation precisionVSAvoiddevice complexity
Core Design Contradiction:
Manufacturing precisionVSDevice complexity

Solution Approach 1:

The control circuit uses feedback from strain gauge measurements to make precise decisions about staple firing. By monitoring staple compression force in real-time and comparing it against predetermined thresholds, the system achieves precise control over staple formation quality, ensuring each staple is formed with adequate compression.

Inventive Principle:
Principle #23Feedback

Solution Approach 2:

The system performs self-verification of staple formation quality through automated strain gauge measurements and control circuit evaluation. Instead of requiring manual inspection or complex external verification systems, the instrument autonomously assesses whether staple compression meets predetermined criteria and controls subsequent staple firing accordingly.

Inventive Principle:
Principle #25Self-service

3Reliability

If the pusher is retracted when staple compression exceeds the range, then the reliability of staple formation is improved, but the productivity of the surgical procedure is reduced

Engineering Contradiction:
Improvestaple formation reliabilityVSAvoidsurgical procedure productivity
Core Design Contradiction:
ReliabilityVSProductivity

Solution Approach 1:

The control circuit continuously monitors staple compression force via strain gauges and provides immediate feedback when compression exceeds predetermined ranges. This real-time feedback enables the system to halt the pusher advancement or retract it when abnormal compression is detected, preventing malformed staple formation while maintaining efficient operation during normal conditions.

Inventive Principle:
Principle #23Feedback

Solution Approach 2:

The system performs preliminary verification of staple compression adequacy before allowing the surgical procedure to continue. By measuring and evaluating staple compression force in advance of subsequent staple firing, the system ensures proper staple formation is achieved proactively, preventing leaks and complications that would require corrective actions later.

Inventive Principle:
Principle #10Preliminary action

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 proper staple formation by preventing leaks, allowing for safe and effective anastomosis procedures by distinguishing between sufficient and insufficient staple formations.

Implementation Method 1

measuring a force of staple compression of a staple being ejected from the staple cartridge by the pusher

Methodology Applied
Scientific EffectStrain gauge measurement: Piezoresistive Effect

Data Source

PatentEP3944824B1Systems for controlling a surgical stapling instrument
Publication Date: 2025.12.17 COVIDIEN LP
  • EP3944824B1 patent drawingFigure 1
  • EP3944824B1 patent drawingFigure 2A
  • EP3944824B1 patent drawingFigure 2B

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 force, the instructions cause the surgical stapling instrument to advance the pusher towards the anvil assembly from a first position to a second position, determine if the pusher stopped advancing towards the anvil assembly prior to the second position, measure a force of staple compression of a staple being ejected from the annular staple cartridge by the pusher, in response to the pusher having stopped advancing towards the anvil assembly, and determine if the force of staple compression is outside of a predetermined range