Epicardial Lead Side Helical Fixation Wedging
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Solution Overview
Problem
Existing epicardial lead implantation methods are traumatic and require surgical access, leading to longer recovery times and inability to solely attach to epicardial tissue, as they often penetrate beyond the epicardium and reside in the myocardium for stimulation.
Innovation Solution
An epicardial lead with a side helical fixation member that includes a set of windings around the lead body circumference and a sharpened elongated flat free end, allowing it to attach solely to the epicardial tissue by wedging into the outer surface, preventing penetration into the myocardium.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If surgical access is used for epicardial lead implantation, then secure fixation to epicardial tissue is achieved, but tissue trauma increases and recovery time lengthens
Solution Approach 1:
The helical fixation member uses a tapered geometry with increasing diameter along its length, changing the physical parameters of the fixation structure to achieve secure anchoring in epicardial tissue without requiring surgical exposure. The taper ratio and diameter specifications optimize the balance between fixation strength and tissue displacement.
2Stability of the object's composition
If traditional helical fixation is used, then lead stability is improved, but the lead penetrates beyond epicardial tissue into myocardium
Solution Approach 1:
The helical fixation member is designed with non-uniform diameter distribution, being narrower at the distal tip for precise epicardial engagement and wider proximally for structural support. This local variation in geometry ensures the lead anchors securely in the epicardium without penetrating into the myocardium, achieving both stability and placement precision.
3Loss of time
If percutaneous approach is used, then recovery time is reduced, but fixation reliability decreases
Solution Approach 1:
The helical fixation member is designed to be self-anchoring through its tapered geometry and helical configuration, allowing it to secure the lead in epicardial tissue through minimal percutaneous access without requiring surgical fixation techniques. The structure itself provides the fixation mechanism, eliminating the need for additional surgical intervention.
4Strength
If the helical fixation member has larger diameter, then fixation strength increases, but tissue displacement increases
Solution Approach 1:
The helical fixation member employs a tapered diameter profile that transitions from a smaller distal tip for minimal tissue disruption to a larger proximal section for enhanced fixation strength. This gradual parameter change allows the structure to anchor securely while minimizing the volume of tissue displaced during implantation.
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 epicardial lead minimizes tissue trauma, reduces recovery time, and allows for optimal placement of electrodes on the heart surface, enhancing therapy delivery such as CRT and defibrillation without the need for surgical access, enabling quicker hospital stays and fewer complications.
Implementation Method 1
a distal tip comprising a sharpened elongated flat free end that is perpendicular to the lead body and angled toward an inside of the set of windings
Data Source
AI summary
A method and system for employing a medical device is disclosed. The medical device includes a housing, a processor disposed within the housing, a connector module, and a medical electrical epicardial lead connected to the processor through the connector module. The epicardial lead is used to sense a cardiac signal from tissue of a patient. The lead comprises an insulative lead body that includes a proximal end and a distal end, at least one conductor disposed in the lead body, and a side helical fixation member, disposed a distance from the distal end, the side helical fixation member. The side helical fixation member comprises a set of windings configured to wrap around the lead body circumference. The side helical fixation member includes a distal tip comprising a sharpened elongated flat free end that is perpendicular to the lead body and angled toward an inside of the set of windings.