Rotatable Lead Introducer for Epicardial-Myocardial Placement
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Solution Overview
Problem
Current methods for placing epicardial-myocardial leads, particularly for resynchronization therapy, face challenges such as dislodgement, increased fluoroscopy exposure, and anatomical infeasibility, especially when trying to access the left ventricle, which limits the effectiveness and invasiveness of minimally invasive procedures.
Innovation Solution
A device that allows for controllable bending, release, and rotation of the lead introducer, enabling precise placement of epicardial-myocardial leads with a helical electrode, including mechanisms like pivot points, push-pull rods, and torque transmission through flexible sleeves, to accommodate complex heart anatomy and minimize trauma during minimally invasive procedures.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Adaptability or versatility
If traditional rigid lead introducers are used, then the structure is simple and easy to manufacture, but the device cannot accommodate complex heart anatomy and requires straight-line approach which is extremely challenging for minimally invasive procedures
Solution Approach 1:
The introducer is divided into multiple segments with articulation joints, allowing each segment to be independently positioned and oriented. This segmentation enables the distal tip to reach complex anatomical targets like the left ventricle apex while keeping the proximal portion accessible through minimally invasive ports, resolving the contradiction between adaptability and complexity.
Solution Approach 2:
The introducer incorporates dynamic articulation joints and flexible segments that can be real-time adjusted during the procedure. The distal portion can be dynamically positioned at various angles relative to the proximal portion, allowing adaptation to complex heart anatomy while maintaining a relatively simple overall device structure.
2Reliability
If CS leads are used to place LV lead, then the lead can be placed in coronary vein, but the procedure requires considerably more time and increased fluoroscopy exposure, and the lead may dislodge in 10%+ of patients
Solution Approach 1:
The introducer is pre-configured with a distal tip that can be positioned at the target location before the lead is fully deployed. The articulation joints are pre-adjusted to the required angles, and the lead is releasably engaged at the optimal position, eliminating the need for time-consuming adjustments and fluoroscopy during the procedure while ensuring stable placement.
3Manufacturing precision
If epicardial leads are placed through sternotomy, then the lead can be placed on the apex of the heart, but the invasiveness of full sternotomy would not be well tolerated by CHF patients
Solution Approach 1:
The articulation joints act as intermediaries that translate the simple port insertion into precise distal tip positioning. The flexible segments and joints allow the introducer to navigate around anatomical obstacles and reach the apex of the heart through minimally invasive ports, providing precise lead placement without requiring sternotomy and reducing patient trauma.
4Ease of operation
If the port ID and length limit the amount of curvature that can preexist in an implant tool, then the device can be inserted through the port, but the alignment between the point of entering the body and the implant position on the heart becomes extremely challenging
Solution Approach 1:
The introducer features dynamic articulation joints that can be adjusted during the procedure to achieve precise alignment. The distal portion can be independently oriented relative to the proximal portion, allowing the operator to compensate for port limitations and achieve accurate lead placement even with restricted curvature, while maintaining ease of single-handed operation.
Data Source
AI summary
Minimally invasive introducers and methods that can be used for rotationally securing devices within the human body. Introducers can include a distal element for releasably engaging a lead head controllable from a proximal control located outside of the body. An inner stem can extend between a proximal portion and a distal portion, and be pivotally and rotatably coupled to the distal lead engagement mechanism. An outer tube can be rotatably disposed over the inner stem and be flexibly coupled over the pivot to rotationally drive the distal element. A helical epicardial-myocardial lead electrode can be secured and oriented straight ahead and introduced through a port or small incision with the introducer in a straight configuration. The introducer can then be bent and rotated to screw the helical electrode into the heart.