Surgical Stapler Reload Indicator with Color-Changing LED
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Solution Overview
Problem
Surgical stapling devices with disposable reloads lack a visible indicator to inform clinicians of the reload's condition, leading to potential reuse of spent reloads and contamination issues during procedures.
Innovation Solution
A reload assembly with a movable indicator that changes color from green to red upon staple ejection, supported by a drive assembly and illuminating device, providing visual feedback on the reload's status and improving visualization during surgical procedures.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If a lockout mechanism is used to prevent reuse of spent reloads, then reliability is improved, but visibility of the spent state to the clinician deteriorates
Solution Approach 1:
The patent employs color-changing indicia that transition from a first color (e.g., green) indicating a fresh reload to a second color (e.g., red) indicating a spent reload. This visual feedback mechanism allows the clinician to immediately identify the reload status without attempting to fire the device, while the lockout mechanism simultaneously prevents accidental reuse of spent reloads.
2Loss of information
If a movable indicator is added to show reload status, then visibility of spent state is improved, but device complexity increases
Solution Approach 1:
The indicator mechanism is integrated with the existing drive assembly and housing structures. The movable indicator is positioned within the housing and advances in response to drive assembly movement, combining the indication function with the existing mechanical components rather than adding entirely separate systems.
Solution Approach 2:
The indicator automatically advances in response to drive assembly movement during the normal firing process. The system self-updates the visual status without requiring separate control mechanisms, and the lockout feature automatically engages to prevent reuse of spent reloads.
3Ease of operation
If an illuminating device is added to enhance visualization, then ease of operation is improved, but use of energy increases
Solution Approach 1:
The illuminating device operates periodically or on-demand rather than continuously, providing illumination when needed for visualization during the surgical procedure while conserving battery energy when not in use.
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 clear indication of a reload's freshness or spent state, preventing reuse of spent reloads and enhancing procedural safety by providing visual feedback through color change and illumination.
Implementation Method 1
the illuminating device is a light emitting diode
Implementation Method 2
The indicator includes first and second indicia. The first indicium is positioned beneath the window of the housing in the retracted position of the indicator and the second indicium is positioned beneath the window of the housing in the advanced position of the indicator.
Data Source
AI summary
A reload assembly is disclosed that includes a proximal body portion having an indicator that is movable from a retracted position to an advanced position to provides a visual indication to a clinician of the state of the reload assembly, i.e., whether the reload assembly is loaded with staples and ready for use or depleted of staples. A tool assembly of the presently disclosed reload assembly may also include a cartridge assembly, an anvil and a drive assembly. In embodiments, one or both of the cartridge assembly, the anvil, and/or the drive assembly may support an illuminating device. In embodiments, the illuminating device, which may be an LED, is adapted to change color when the reload assembly has been fired to provide an indication to a clinician that the reload assembly is spent. Since the illuminating device is illuminated when reload assembly is in both the unused and spent states, the illuminating device also improves visualization during placement and use of the reload assembly.