Adaptive Tissue Compression for Surgical Staplers

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Solution Overview

Problem

Current surgical stapling and cutting instruments face challenges in controlling tissue compression to ensure consistent power application and prevent tissue damage during closure, as existing methods do not effectively adjust closure rates based on real-time tissue pressure measurements.

Innovation Solution

A surgical instrument equipped with sensors to determine tissue pressure and a processor that adjusts the closure rate by executing control measures to maintain an acceptable rate of change in tissue pressure, thereby preventing excessive power application and minimizing tissue damage.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Productivity

If the closure rate is increased to improve surgical productivity, then the procedure time is reduced, but the tissue pressure changes too rapidly causing power spikes and potential tissue damage

Engineering Contradiction:
Improvesurgical procedure efficiencyVSAvoidtissue damage from excessive power application
Core Design Contradiction:
ProductivityVSObject-affected harmful factors

Solution Approach 1:

The system continuously monitors tissue pressure during closure and uses this feedback to dynamically adjust the closure rate. When pressure exceeds a threshold or its rate of change is too high, the system automatically reduces the closure rate to prevent power spikes and tissue damage, while still allowing for efficient closure when conditions permit.

Inventive Principle:
Principle #23Feedback

Solution Approach 2:

The closure rate is made dynamic rather than fixed, allowing the system to adapt in real-time based on tissue characteristics and pressure conditions. The controller adjusts the closure rate within a range from a first rate to a second rate, optimizing both surgical efficiency and tissue safety throughout the closure process.

Inventive Principle:
Principle #15Dynamics

2Object-affected harmful factors

If the closure rate is reduced to prevent tissue damage, then power application remains controlled, but the surgical procedure time increases

Engineering Contradiction:
Improvetissue damage preventionVSAvoidclosure time
Core Design Contradiction:
Object-affected harmful factorsVSLoss of time

Solution Approach 1:

The system applies a more aggressive closure rate (excessive action) when tissue conditions allow, and a more conservative rate when pressure thresholds are approached. This partial application of different closure rates optimizes the balance between speed and safety, using full speed only when safe to do so.

Inventive Principle:
Principle #16Partial or excessive action

Solution Approach 2:

The system changes the closure rate parameter dynamically based on real-time pressure measurements and their rate of change. By adjusting this key parameter in response to measured conditions, the system achieves both fast closure when possible and tissue protection when necessary.

Inventive Principle:
Principle #35Parameter changes

3Device complexity

If a fixed closure rate is used to simplify control, then device complexity is reduced, but consistent power application cannot be maintained across different tissue types

Engineering Contradiction:
Improvecontrol system simplicityVSAvoidpower application consistency
Core Design Contradiction:
Device complexityVSReliability

Solution Approach 1:

The system replaces simple mechanical control with sensor-based measurement and electronic control. Pressure sensors provide real-time data to a controller that adjusts the closure rate, substituting complex mechanical mechanisms with a more compact sensor-electronics-control system that achieves better consistency.

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

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 instrument ensures consistent and controlled tissue compression, reducing the risk of tissue damage by dynamically adjusting closure rates based on real-time pressure measurements, enhancing the safety and efficacy of surgical procedures.

Implementation Method 1

one or more sensors adapted to determine tissue pressure

Methodology Applied
Scientific EffectPressure sensing:

Implementation Method 2

The rate of change of average tissue pressure is determined as a parameter... In response to determining that a measured value of the parameter has exceeded the acceptable value, the second control measure is executed, wherein the second control measure decreases the closure rate

Methodology Applied
Scientific EffectFeedback control: Feedback

Data Source

PatentEP3264995B1Adaptive tissue compression techniques to adjust closure rates for multiple tissue types
Publication Date: 2022.10.12 ETHICON INC
  • EP3264995B1 patent drawingFigure 1
  • EP3264995B1 patent drawingFigure 2
  • EP3264995B1 patent drawingFigure 3

AI summary

A mechanism is disclosed for adapting operations of a surgical instrument based on data from actual, expected or predicted properties of tissue, data from measuring operation of the surgical instrument itself, and data based on clinician conduct. The adaptive measures can be based on predetermined control measures such as algorithms stored in operative communication with the surgical instrument, based on dynamically generated control measures, or a combination of both. Utilizing such mechanisms can help to adjust closure and firing algorithms based on tissue properties, improve battery usage, and learn from user operations, enhancing functioning of the instrument within an operational envelope.