Tunnel Device for Subcutaneous Implantable Cardio Defibrillator
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Solution Overview
Problem
The insertion of subcutaneous implantable devices, such as cardio defibrillators, is challenging due to the tortuous path they must traverse, especially in pediatric and neonatal patients, requiring multiple redirects and incisions to achieve the desired placement.
Innovation Solution
A tunnel device with an elongate outer sleeve and inner glide system that allows for 90-degree pivoting within subcutaneous tissue without the need for additional incisions, utilizing a pivot arm and guide arm mechanism to facilitate the redirection of the device.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If multiple incisions are made to redirect the device during insertion, then the device can be placed at the desired location, but tissue disruption and procedural complexity increase
Solution Approach 1:
A tunnel device with a curved trajectory is introduced as an intermediary tool to guide the implantable device through subcutaneous tissue. The tunnel device creates a pre-formed pathway that allows the implantable device to redirect without requiring additional incisions, thus reducing tissue disruption while maintaining placement accuracy
Solution Approach 2:
The tunnel device is inserted and positioned first to create a prepared pathway before the implantable device is introduced. This preliminary action establishes a safe tunnel through the tissue that the implantable device can follow, avoiding the need for real-time redirection through additional incisions
2Reliability
If the device is redirected multiple times inside subcutaneous tissue, then the desired placement location can be reached, but the difficulty of insertion increases
Solution Approach 1:
The tunnel device incorporates a curved or bent trajectory rather than a straight path. This curvature allows the device to navigate around anatomical structures and achieve redirection within the subcutaneous tissue plane, making insertion easier by following natural tissue contours rather than requiring sharp angular changes through incisions
Solution Approach 2:
The tunnel device utilizes the third dimension by creating a tunnel that passes through tissue at an angle or depth, allowing redirection in a direction that would otherwise require a second incision. This dimensional approach simplifies the insertion process by using depth and angle rather than multiple surface access points
3Object-affected harmful factors
If a single incision is used, then tissue disruption is minimized, but the ability to redirect the device is limited
Solution Approach 1:
The tunnel device is designed with flexibility or articulation that allows it to change direction dynamically within the subcutaneous tissue. This dynamic capability enables the device to redirect along a curved path through a single incision, maintaining versatility while minimizing tissue disruption
Solution Approach 2:
The tunnel device may incorporate segmented or articulated sections that can bend or pivot to change direction. This segmentation allows the device to navigate complex pathways and achieve redirection capabilities equivalent to multiple incisions while maintaining a single access point
Data Source
AI summary
A directional tunnel device for a subcutaneous implantable device is provided. The tunnel device includes an elongate outer sleeve having an open proximal end and an open distal end. An elongate outer trough has a trough proximal end, a trough distal end, and a concave cradle extending between the trough proximal end and the trough distal end. The outer trough is sized to slidingly fit inside outer sleeve such that the outer sleeve is slidable externally along the outer trough. An inner glide rests in the cradle. The inner glide includes an inner trough, a guide arm connected to a distal end of the inner trough, and a pivot arm connected to a distal end of the guide arm.