Extracardiovascular Lead Deployment Tool for Substernal Insertion
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Solution Overview
Problem
Existing implantable medical electrical leads implanted transvenously within the heart can face challenges such as vascular access difficulties and fibrosis, making revision and extraction procedures complicated, particularly in extracardiovascular sites like the substernal space.
Innovation Solution
A tool with a guide and deployment assembly is used to insert an elongate medical device, such as an implantable medical electrical lead, into an extracardiovascular site like the substernal space, featuring a retainer and slider system that allows for controlled movement and deployment of the lead along a track, minimizing the need for tunnel creation and reducing the risk of air introduction.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Ease of operation
If transvenous implantation is used, then vascular access is achieved, but fibrosis occurs making revision and extraction difficult
Solution Approach 1:
The implantation approach is segmented into two distinct pathways: transvenous route and extracardiovascular route. The patent provides separate implantation systems for each pathway, allowing clinicians to choose the appropriate route based on patient anatomy and avoiding fibrosis-related complications by using an alternative pathway when transvenous access is problematic
Solution Approach 2:
The patent introduces an intermediary implantation pathway (extracardiovascular space) that serves as a mediator between the pulse generator and the heart. This intermediary route avoids direct venous traversal, reducing fibrosis formation while still enabling effective cardiac stimulation through the heart wall
2Reliability
If transvenous leads are implanted, then cardiac therapy delivery is achieved, but lead fibrosis makes revision challenging
Solution Approach 1:
The patent segments the implantation strategy into primary implantation and potential revision scenarios, providing different approaches for each. For primary implantation, either transvenous or extracardiovascular routes can be chosen based on predicted future needs. For revisions, the extracardiovascular approach offers easier access and manipulation compared to fibrosed transvenous leads
Solution Approach 2:
The patent applies preliminary action by selecting the implantation route based on predicted future needs. If a patient is likely to require lead revision or extraction, the extracardiovascular approach is chosen beforehand to prevent fibrosis formation, thereby facilitating future revisions without the complications of fibrosed transvenous leads
3Reliability
If extracardiovascular implantation is used, then fibrosis is reduced, but device insertion complexity increases
Solution Approach 1:
The patent introduces a specialized deployment assembly as an intermediary tool that mediates between the surgeon and the lead during extracardiovascular implantation. This tool includes a guide with a track, retainer, and slider components that work together to simplify the complex task of navigating and deploying the lead through the extracardiovascular space while minimizing air introduction and tissue trauma
4Ease of repair
If lead extraction is performed on fibrosed leads, then lead removal is attempted, but procedure difficulty and risk increase
Solution Approach 1:
The patent applies preliminary action by choosing the extracardiovascular implantation route beforehand to prevent fibrosis formation. This preliminary decision avoids the harmful effects of fibrosis that would otherwise make extraction difficult and risky, thereby facilitating easier and safer lead removal when revision is needed
Solution Approach 2:
The patent converts the potential harm of complex extracardiovascular implantation into a benefit by demonstrating that the initial complexity prevents future harm. The more complex initial implantation procedure avoids fibrosis formation, which would create even greater complexity and risk during extraction, thereby making the initial complexity worthwhile
Data Source
AI summary
A tool for inserting an elongate medical device into a body includes a track (e.g. defined by inner surfaces of a base wall and opposing sidewalls), and a deployment assembly for moving the device along the track. A retainer of the assembly, fitted in sliding engagement within the track and limited to move only along a portion of the track, grips a first portion of a proximal length of the device; a slider of the assembly, also fitted in sliding engagement within the track and detachably joined to the retainer, receives a second portion of the device proximal length. When detached from the retainer, the slider is free to move along a distal length of the device, and can be moved along a distal segment of the track to disengage therefrom by separating from a distal terminal end of the guide.