Balloon-Actuated Sheath for Protected Helix Delivery and Fixation
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Solution Overview
Problem
Interventional medical devices face challenges in protecting delicate tools from damage during delivery to the target site and ensuring safe interaction with non-target tissue, particularly with active fixation mechanisms like screw-in helixes, which are prone to dislodgement and require repositioning.
Innovation Solution
A balloon-actuated cover mechanism that uses inflation and deflation to protect and expose tools, such as a screw-in helix, by translational movement of a sheath or cap, providing a protective sheath or cap that covers the tool during delivery and uncovers it at the target site.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If a tooltip with active fixation mechanism is used, then fixation reliability is improved, but the tool becomes more prone to dislodgement during delivery
Solution Approach 1:
The sheath is extended in advance during the delivery phase to cover and protect the active fixation mechanism (helix) before it reaches the target site. This preliminary protective action prevents the helix from dislodging or causing harm during transit through the vascular system, while still allowing the device to be delivered to the intended location.
Solution Approach 2:
The sheath is designed to be dynamically controllable through balloon actuation. During delivery, the sheath is extended to protect the helix. Upon reaching the target site and after balloon deflation, the sheath can be retracted to expose the helix for fixation. This dynamic transition allows the same component to serve both protective and functional roles at different stages.
2Ease of operation
If the tooltip is exposed during delivery, then ease of operation is improved, but the tool is vulnerable to damage and tissue interaction
Solution Approach 1:
The sheath is extended in advance during the delivery phase to cover and protect the active fixation mechanism (helix) before it reaches the target site. This preliminary protective action prevents the helix from dislodging or causing harm during transit through the vascular system, while still allowing the device to be delivered to the intended location.
Solution Approach 2:
The sheath is designed to be dynamically controllable through balloon actuation. During delivery, the sheath is extended to protect the helix. Upon reaching the target site and after balloon deflation, the sheath can be retracted to expose the helix for fixation. This dynamic transition allows the same component to serve both protective and functional roles at different stages.
3Reliability
If the sheath is extended to protect the tooltip, then safety is improved, but the tool cannot be used at the target site
Solution Approach 1:
The sheath is designed to be dynamically controllable through balloon actuation. During delivery, the sheath is extended to protect the helix. Upon reaching the target site and after balloon deflation, the sheath can be retracted to expose the helix for fixation. This dynamic transition allows the same component to serve both protective and functional roles at different stages.
Solution Approach 2:
The sheath transitions between extended and retracted states in a periodic manner corresponding to different phases of the procedure. Extended during delivery for protection, retracted after balloon deflation for tool usage. This periodic state change ensures both safety during transit and functionality at the target site.
4Reliability
If the balloon is inflated to extend the sheath, then protection is improved, but the device volume increases
Solution Approach 1:
The sheath is nested within the balloon structure, allowing it to be contained within the balloon's volume when extended. This nesting arrangement enables the sheath to provide protection while minimizing the overall increase in device volume, as the protective component utilizes the existing balloon space rather than adding separate external structure.
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
Enhances safety and efficacy by preventing tool damage and ensuring proper fixation, reducing dislodgement risks, and allowing controlled exposure of tools like helixes for targeted use.
Implementation Method 1
A balloon-actuated cover mechanism that uses inflation and deflation to protect and expose tools
Implementation Method 2
a radially inflatable middle portion between the proximal portion and the distal portion of the balloon
Data Source
AI summary
Medical devices including a balloon-actuated sheath are provided. The medical devices include a tubular body, a tooltip, a balloon, and a tubular sheath translatably coupled to the balloon. Medical devices including a balloon-actuated distal cap are provided. The medical devices include a tubular body, a tooltip, a balloon, and a distal cap translatably coupled to the balloon. When air is pushed into one end of the medical device, the balloon may inflate, translating the tubular sheath or distal cap along a longitudinal axis from a retracted position to an extended position. When in the extended position, the tubular sheath at least partially surrounds the tooltip. When in the extended position, the distal cap at least partially opens fluid communication between the tooltip and the environment.