Surgical Instrument Sensor Logging for Failure Cause Analysis

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Solution Overview

Problem

Endoscopic surgical instruments, such as surgical staplers, often fail without clear cause determination, requiring extensive analysis and leading to costly design changes, as current technologies lack effective feedback mechanisms for user control and condition monitoring.

Innovation Solution

Incorporating sensors and a memory device in surgical instruments to record and provide outputs of various conditions, including user feedback on deployment force and position, allowing for improved monitoring and analysis of instrument operations.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Measurement precision

If sensors and memory device are incorporated in surgical instruments to record conditions, then measurement precision and reliability are improved, but device complexity increases

Engineering Contradiction:
Improvecondition monitoring accuracyVSAvoidinstrument structure
Core Design Contradiction:
Measurement precisionVSDevice complexity

Solution Approach 1:

The patent integrates sensors and a memory device within the existing surgical instrument structure. The sensors are positioned to monitor specific conditions (temperature, pressure, position) at critical locations, while the memory device stores recorded data. This nested arrangement allows condition monitoring functionality to be embedded without significantly increasing the overall instrument footprint or complexity.

Inventive Principle:
Principle #7Nested doll (Nesting)

Solution Approach 2:

The patent introduces sensors as intermediary elements that mediate between the physical conditions (temperature, pressure, position) and the recording system. These sensors convert physical parameters into measurable signals that can be stored and analyzed, enabling precise condition monitoring while maintaining a clear separation between the monitoring function and the surgical function.

Inventive Principle:
Principle #24Intermediary (Mediator)

2Loss of information

If detailed condition recording is implemented, then loss of information is reduced, but manufacturing precision requirements increase

Engineering Contradiction:
Improvefailure analysis dataVSAvoidsensor placement accuracy
Core Design Contradiction:
Loss of informationVSManufacturing precision

Solution Approach 1:

The patent positions sensors at predetermined locations within the instrument before use. The sensor placement is designed during the instrument design phase to capture critical conditions at key locations. This preliminary positioning ensures that when the instrument is manufactured and assembled, the sensors are already in optimal positions to record meaningful data, reducing the need for post-manufacturing adjustments and minimizing the impact of manufacturing tolerances.

Inventive Principle:
Principle #10Preliminary action

3Reliability

If multiple sensors are added to monitor various conditions, then reliability is improved, but device complexity and manufacturing cost increase

Engineering Contradiction:
Improvefailure cause determinationVSAvoidnumber of components
Core Design Contradiction:
ReliabilityVSDevice complexity

Solution Approach 1:

The patent employs sensors that can monitor multiple conditions or parameters. For example, a single sensor system is designed to capture temperature, pressure, and position data, or to monitor conditions across multiple locations within the instrument. This multi-functional approach allows comprehensive condition monitoring with fewer sensor components, thereby improving reliability without proportionally increasing device complexity.

Inventive Principle:
Principle #6Universality (Multi-functionality)

Data Source

PatentEP1813201B1Surgical instrument having recording capabilities
Publication Date: 2016.01.27 ETHICON ENDO SURGERY INC
  • EP1813201B1 patent drawingFigure 1
  • EP1813201B1 patent drawingFigure 2
  • EP1813201B1 patent drawingFigure 3

AI summary

The surgical instrument (10) has an end effector (12) and a trigger (18,20) in communication with the end effector. The surgical instrument also has a first sensor (110,130,142,2002,2004,2006,2008,2010) and an externally accessible memory device (2001) in communication with the first sensor. The first sensor has an output that represents a first condition of either the trigger or the end effector. The memory device is configured to record the output of the first sensor. In various embodiments, memory device may include an output port (2020) and/or a removable storage medium (2021).