Tether Assembly Retainer Mechanism for One-Person Device Loading
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Solution Overview
Problem
Existing medical device delivery systems require two clinicians to load an implantable medical device onto a tether assembly, increasing procedural time and complexity and risking contamination, while also being non-intuitive and prone to accidental deployment.
Innovation Solution
A tether assembly with a biased inner retainer mechanism that allows one-person loading by compressing an elastically-compressible member to open and close, and a tether handle assembly that translates distally-directed force into proximally-directed force for intuitive release, reducing the need for multiple operators and enhancing safety.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If a traditional tether assembly requires two clinicians to load the medical device, then the device can be securely loaded, but the procedural time increases and the complexity increases and the risk of contamination increases
Solution Approach 1:
The tether assembly's inner retainer automatically opens when the medical device is inserted and automatically closes to secure it, eliminating the need for manual operation by multiple clinicians. The system performs the loading function autonomously through its mechanical design.
Solution Approach 2:
The elastically-compressible member is pre-loaded in a compressed state during manufacturing, storing the energy needed to automatically open the retainer when the device is inserted. This preliminary preparation enables the automatic loading function without requiring additional procedural time.
2Reliability
If a traditional tether assembly requires two clinicians to load the medical device, then the device can be securely loaded, but the device complexity increases
Solution Approach 1:
The tether assembly autonomously performs the loading function through its self-actuating mechanism. The inner retainer automatically opens and closes based on the insertion and removal of the medical device, eliminating the need for complex manual coordination between multiple clinicians.
Solution Approach 2:
The tether assembly is divided into distinct functional components: the inner retainer, the elastically-compressible member, and the outer housing. This segmentation allows each component to perform its specific function independently, simplifying the overall loading process while maintaining reliability.
3Reliability
If a traditional tether assembly requires two clinicians to load the medical device, then the device can be securely loaded, but the risk of contamination increases
Solution Approach 1:
The tether assembly automatically loads the medical device without requiring multiple clinicians to manually handle it. This reduces the number of times the device is touched and the risk of introducing contaminants during the loading process.
Solution Approach 2:
The elastically-compressible member is pre-compressed during manufacturing to store the energy needed for automatic retainer opening. This preliminary preparation eliminates the need for manual compression during the procedure, reducing contamination risk.
4Volume of moving object
If the tether handle assembly uses a non-intuitive force transmission mechanism, then the device can be compact, but the ease of operation decreases and accidental deployment increases
Solution Approach 1:
The tether handle assembly inverts the conventional force transmission approach by using a distally-directed push force to achieve proximal movement of the pull wire. This intuitive push-button mechanism is more natural for users and reduces the risk of accidental deployment compared to pull-based mechanisms.
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 solution enables one-person loading, reduces procedural time and complexity, minimizes contamination risk, and enhances operational safety and reliability of medical device delivery systems.
Implementation Method 1
an elastically-compressible member configured to bias the inner retainer to the first position
Implementation Method 2
a tether handle assembly configured to retain a proximal end of a pull wire of the tether assembly. The tether handle assembly includes one or more components (e.g., an actuator) configured to transmit force to a tether head assembly via the pull wire
Data Source
AI summary
In some examples, a tether head assembly of a delivery system includes an inner retainer and an outer retainer that defines an aperture comprising a receptacle configured to receive an attachment member of a medical device, a passageway, and a groove. The inner retainer is movable within the groove between a second position in which the passageway is dimensioned to receive the attachment member and a first position in which the passageway is dimensioned to prevent passage of the attachment member. In some examples, a tether handle assembly defines a channel, a force transmitter within the channel, a slidable member partially received within a first end of the channel and a button partially received within a second end of the channel. Distally-directed force applied to the button may cause the force transmitter to apply proximally-directed force to the slidable member, moving the slidable member and an attached pull wire proximally.


