Force-Limiting Access System With Dynamic Handle Interface
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Solution Overview
Problem
Minimally invasive medical procedures often cause trauma to the urinary system due to the use of large access sheaths, which can exert forces exceeding the threshold for safe deployment, leading to injuries such as ureteral damage, and existing solutions require impractical force gauges for monitoring.
Innovation Solution
A force-limiting access system with a distal tip section and shaft coupled via an interface that provides tactile, audible, or visual feedback when forces exceed a predetermined threshold, allowing the handle to move independently of the shaft to prevent excessive force application.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Ease of operation
If a large diameter access sheath is used to provide access for therapeutic and diagnostic tools, then the tools can easily advance through the sheath, but the access sheath can cause damage to the lumens into which it is advanced
Solution Approach 1:
The interface between the handle and shaft is designed to be dynamic rather than fixed, allowing it to transition between locked and unlocked states based on the force applied. This dynamic characteristic enables the system to adapt to varying insertion forces, maintaining tool accessibility while preventing excessive force transmission that could cause ureteral injury.
Solution Approach 2:
The system incorporates feedback mechanisms that provide tactile, audible, or visual signals to the operator when the insertion force approaches the threshold for potential injury. This feedback loop allows the operator to adjust their technique in real-time, ensuring safe passage of the access sheath while maintaining procedural effectiveness.
2Reliability
If a force gauge is used to monitor forces being exerted during access sheath deployment, then ureteral injury can be prevented, but the configuration and monitoring of the force gauge is impractical for many operative settings
Solution Approach 1:
The access system performs its own force monitoring function through the interface mechanism that automatically detects when excessive force is applied and provides feedback to the operator. This self-service capability eliminates the need for separate force gauge equipment, making the system both reliable and practical for routine operative settings.
Solution Approach 2:
The interface between the handle and shaft acts as an intermediary mechanism that translates mechanical force into observable feedback signals. This intermediary function allows force monitoring to be integrated into the existing access system without requiring additional complex monitoring equipment.
3Ease of manufacture
If the handle is fixed to the shaft to maintain positional relationship, then precise control is achieved, but excessive force can be transmitted to the distal tip section
Solution Approach 1:
The handle-shaft interface is designed with dynamic characteristics that allow it to transition between locked and unlocked states. When properly engaged, the interface maintains a fixed positional relationship for precise control; when excessive force is applied, the interface unlocks to prevent force transmission, thus protecting the distal tip section.
Data Source
AI summary
A force-limiting access system is provided and includes a distal tip section configured to advance within a body lumen; a shaft coupled with the distal tip section; and a handle coupled with the shaft via an interface. The interface is configured to maintain a positional relationship between the handle and the shaft while the shaft experiences a force less than a threshold force and to allow the handle to move with respect to the shaft when the shaft experiences a force greater than the threshold force.