Surgical Stapling Loading Unit Stroke Counter Lockout
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Solution Overview
Problem
Surgical staplers often require multiple devices during a single procedure due to depletion of staple supply, leading to increased costs and inefficiency, as existing systems lack effective tracking of staple usage and lockout mechanisms to prevent further firing after depletion.
Innovation Solution
A surgical loading unit with a rotatable counter and lockout mechanism that tracks staple firing strokes through a visual indicator system, preventing further firing after a predetermined number of strokes, allowing clinicians to monitor staple supply and replace the unit when necessary.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Loss of information
If surgical staplers are used without a firing stroke counter, then the device structure remains simple, but the clinician cannot effectively monitor staple supply and must replace devices frequently
Solution Approach 1:
A rotatable counter with visual indicators provides real-time feedback on the number of firing strokes completed, allowing clinicians to monitor staple supply without complex electronics. The counter rotates in response to drive movement and displays remaining staples through visual indicators visible through a window.
Solution Approach 2:
The counter system is self-powered through mechanical coupling with the drive mechanism. The drive's longitudinal movement directly rotates the counter via a counter actuator, eliminating the need for external power sources or complex sensing systems.
2Reliability
If surgical staplers lack a lockout mechanism, then the device allows continuous operation, but firing continues after staple depletion causing unnecessary costs
Solution Approach 1:
The lockout mechanism is pre-configured to engage automatically when the counter reaches a predetermined number of strokes. A stop on the counter is positionable to engage the drive upon rotatable movement through a predetermined number of arc segments, preventing further firing before staple depletion occurs.
Solution Approach 2:
The counter provides feedback on the number of firing strokes completed, and this information is used by the lockout mechanism to determine when to prevent further operation. The visual indicators show remaining staples, and the lockout engages when the predetermined limit is reached.
3Productivity
If multiple surgical staplers are used for a single procedure due to staple depletion, then the surgical procedure can be completed, but the cost increases significantly
Solution Approach 1:
The visual indicators on the counter allow clinicians to see remaining staple count and anticipate depletion before it occurs. This enables proactive planning to complete the procedure with a single loading unit, avoiding the need to switch devices and the associated costs.
Solution Approach 2:
The counter acts as an intermediary between the drive mechanism and the clinician, translating mechanical movement into visible information about staple supply status. This enables informed decision-making about when to replace the loading unit.
Data Source
AI summary
A surgical loading unit for use with a handle assembly includes an elongate outer frame defining a longitudinal axis and having proximal and distal ends, an end effector mounted to the distal end of the outer frame, a drive at least partially disposed within the outer frame and operatively coupled to the end effector, and being adapted for longitudinal movement through a plurality of sequential firing strokes to operate the end effector and a rotatable counter mounted to the outer frame. The rotatable counter is adapted for rotational movement through an arc segment of rotation upon movement of the drive through each firing stroke, and has visual indicators for providing visual indicia corresponding to a number of firing strokes completed by the drive.