Rotatable Catheter Trigger Assembly for Consistent Lead Extraction
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Solution Overview
Problem
Existing lead removal devices face challenges such as minimal surface area contact and inconsistent directional movement of drive mechanisms, leading to increased procedure time and user fatigue during lead extraction due to scar tissue, lesions, calcification, and plaque buildup around implanted cardiac pacing system leads.
Innovation Solution
A medical device with a trigger assembly for a rotatable catheter, featuring a housing, catheter, drive assembly, and trigger mechanism, allowing for consistent clockwise and counterclockwise rotation of the catheter through a drive assembly that includes a trigger, drive initiator, drive member, and flip drive, facilitated by a biasing member, enabling efficient tissue dissection and lead extraction.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Device complexity
If a drive mechanism with minimal surface area contact is used, then the device structure is simplified, but the reliability of consistent directional movement deteriorates
Solution Approach 1:
The trigger assembly incorporates a flip drive mechanism that dynamically transitions between neutral, first drive, and second drive positions. This dynamic design allows the drive member to consistently engage with the catheter in a predetermined direction while maintaining operational reliability, resolving the contradiction between simplified structure and consistent directional movement.
Solution Approach 2:
The flip drive acts as an intermediary component between the trigger and the drive member. It ensures consistent directional engagement by mediating the force transmission, preventing minimal surface area contact issues while maintaining structural simplicity. The biasing member further mediates the return to neutral position, ensuring reliable resetting.
2Device complexity
If a drive mechanism that prevents consistent alternating movement is used, then the device complexity is reduced, but the productivity of lead extraction deteriorates
Solution Approach 1:
The trigger assembly enables periodic alternating movement between first and second drive positions through the flip drive mechanism. Each trigger pull initiates a controlled sequence that alternates rotation directions, improving lead extraction productivity while maintaining manageable device complexity through standardized periodic operation.
Solution Approach 2:
The drive mechanism maintains continuous useful action by ensuring the drive member consistently engages with the catheter during each activation cycle. The biasing member ensures continuous readiness by automatically returning the flip drive to neutral position, eliminating idle time and improving overall extraction productivity.
3Device complexity
If manual lead extraction without a trigger assembly is used, then the device structure is simpler, but the duration of the extraction procedure increases
Solution Approach 1:
The trigger assembly incorporates a self-service mechanism where the biasing member automatically returns the flip drive to the neutral position after each activation. This self-resetting feature reduces procedure time by eliminating manual resetting operations, justifying the added structural complexity of the trigger assembly.
Solution Approach 2:
The trigger assembly prepares the drive mechanism in advance by pre-positioning the flip drive and drive member for immediate engagement. This preliminary action reduces procedure time by eliminating setup delays during the extraction process, making the additional structural complexity worthwhile.
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 device reduces procedure time and user fatigue by providing reliable, uni-directional rotation of the catheter, enhancing the efficiency of lead extraction by effectively dissecting scar tissue and other obstructions.
Implementation Method 1
The biasing member is disposed within the chamber and biases the flip drive to the neutral position when the drive initiator is in the first position
Data Source
AI summary
Medical devices that include a trigger assembly for a rotatable catheter and methods of use are described. An example medical device includes a housing, a catheter, a drive assembly, and a trigger assembly. The trigger assembly is partially disposed within the housing and includes a trigger, a drive initiator, a drive member, a flip drive, and a biasing member. The trigger is moveable between a first position and a second position relative to the housing. The flip drive is moveable between a neutral position, a first drive position, and a second drive position. The drive assembly moves relative to the housing when the flip drive is in the first drive position and the trigger is moved from its first position to its second position.