Tether Head Assembly for One-Person Medical 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 less 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 move the inner retainer between positions, enabling secure attachment and release of the medical device with a distally-directed force, and incorporating a tether handle assembly for intuitive operation and reduced accidental release.
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 and complexity increase and contamination risk rises
Solution Approach 1:
The tether assembly is designed with a self-latching mechanism where the attachment member automatically engages with the retainer when the medical device is inserted. The biasing element (spring) automatically returns the retainer to the retained position after loading, eliminating the need for a second clinician to manually secure the device. This self-service mechanism reduces procedural time while maintaining secure loading through automatic engagement and retention.
2Reliability
If a traditional tether assembly requires two clinicians to load the medical device, then the device can be securely loaded, but the procedural complexity increases
Solution Approach 1:
The automatic self-latching mechanism with biasing element eliminates the need for coordinated manual operation between two clinicians. The system performs the securing action automatically through mechanical engagement and spring-driven return, simplifying the procedure to a single-clinician operation while maintaining reliable device retention.
3Reliability
If a traditional tether assembly requires two clinicians to load the medical device, then the device can be securely loaded, but the contamination risk increases
Solution Approach 1:
The self-latching mechanism requires only one clinician to insert the medical device, automatically securing it through the retainer and biasing element system. This reduction in the number of personnel handling the device minimizes the opportunities for contamination while maintaining secure loading through automatic mechanical retention.
4Productivity
If the tether assembly allows easy loading, then the procedural time is reduced, but accidental deployment may increase
Solution Approach 1:
The retainer is biased by a spring element to maintain continuous engagement with the attachment member, creating a preliminary restraining force that prevents accidental deployment. The quick-release mechanism requires deliberate manual intervention to overcome this biasing force and disengage the retainer, thus preventing accidental release while allowing rapid intentional deployment when needed.
5Ease of operation
If the inner retainer is biased to the first position, then one-person loading is enabled, but the mechanism complexity increases
Solution Approach 1:
The biasing element automatically returns the retainer to the engaged position after the medical device is inserted, enabling one-person loading without requiring complex manual manipulation. The spring mechanism provides automatic resetting functionality, simplifying the loading process to a single insertion action while maintaining the retainer in the secure first position through elastic restoration.
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 tether assembly reduces procedural time and complexity, minimizes contamination risk, enhances operational intuitiveness, and prevents accidental deployment, while being reusable and compatible with drug-eluting components by allowing separate packaging.
Implementation Method 1
an elastically-compressible member configured to bias the inner retainer to the first position
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.