Tether Head Assembly for Single-Operator 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 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 the retainer to secure the device, and a handle assembly that translates a distally-directed force into a 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 onto the tether assembly, but the procedural time and complexity increase and contamination risk increases
Solution Approach 1:
The tether assembly's inner retainer is designed to automatically engage with the medical device's attachment member when the device is inserted into the tether head assembly. The biasing element (spring) automatically pushes the inner retainer into the engaged position, 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 mechanical engagement.
2Reliability
If a traditional tether assembly requires two clinicians to load the medical device, then the device can be securely loaded onto the tether assembly, but the procedural complexity increases
Solution Approach 1:
The automatic engagement mechanism with biasing element eliminates the need for coordinated manual operation by two clinicians, simplifying the procedure to a single-operator task while maintaining secure device loading through automated mechanical retention.
Solution Approach 2:
The tether head assembly is segmented into distinct functional components: the inner retainer for device retention, the biasing element for automatic engagement, and the outer housing for structural support. This segmentation allows each component to perform its specific function independently, simplifying the overall loading procedure while ensuring reliable device securation.
3Reliability
If a traditional tether assembly requires two clinicians to load the medical device, then the device can be securely loaded onto the tether assembly, but the contamination risk increases
Solution Approach 1:
The automatic engagement mechanism requires only one clinician to insert the device, minimizing the number of personnel handling the implantable device and thereby reducing contamination risk while still achieving secure device loading through automated retention.
Solution Approach 2:
The biasing element is pre-loaded in a compressed state within the tether head assembly, ready to immediately engage the device upon insertion. This preliminary preparation allows the single clinician to complete the loading process quickly without manual intervention from a second clinician, reducing exposure time and contamination risk.
4Ease of operation
If the inner retainer is not biased to return to the first position, then the tether assembly can be loaded by one person, but the device may not be securely retained after loading
Solution Approach 1:
The biasing element automatically returns the inner retainer to the engaged position after the device is inserted, providing both single-person operability and secure device retention through automated mechanical action without requiring manual intervention from multiple clinicians.
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 faster, more reliable, and less complex device delivery with reduced contamination risk, allowing single-person operation and improved control over device placement and release.
Implementation Method 1
an elastically-compressible member of the tether head assembly may expand and apply distally-directed force to the inner retainer, thereby moving the inner retainer from the second position to the first position
Data Source
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AI summary
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. 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.