Epicardial Lead Delivery via Suction and Puncture
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Solution Overview
Problem
Epicardial lead placement for cardiac resynchronization therapy is often invasive and requires significant skill due to the small size and tortuosity of cardiac veins, limiting therapeutic options and requiring more invasive procedures compared to transvenous leads.
Innovation Solution
A medical electrical lead with a longer helical tip electrode and flexible anode, combined with a delivery system using a suction device and puncture tool, allows for epicardial implantation through a less invasive approach, such as mini-thoracotomy, with stabilization members promoting tissue adhesion to secure the lead without anchoring sutures.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Ease of operation
If transvenous lead placement is used, then minimally invasive procedure is achieved, but therapeutic options are limited and implant sites are restricted to cardiac vein pathways
Solution Approach 1:
The lead system is divided into separate components: a delivery catheter for minimally invasive access and a lead body with electrodes that can be positioned at various epicardial locations. This segmentation allows the minimally invasive delivery approach to achieve versatile therapeutic placement options that were previously incompatible.
Solution Approach 2:
The delivery catheter acts as an intermediary device that enables minimally invasive access to the epicardial surface. Through the catheter, the lead can be delivered to and fixed at optimal epicardial sites without requiring traditional sternotomy, thus mediating between minimally invasive procedure requirements and versatile therapeutic placement needs.
2Adaptability or versatility
If epicardial lead placement is used, then therapeutic options are improved, but procedure invasiveness increases requiring sternotomy
Solution Approach 1:
The traditional mechanical approach of sternotomy is replaced with a catheter-based delivery system that uses suction and puncture mechanisms. This substitution eliminates the need for open chest surgery while enabling epicardial lead placement, thus reducing procedure invasiveness while maintaining therapeutic versatility.
Solution Approach 2:
The lead design parameters are optimized for epicardial fixation, including a longer helical tip electrode and flexible anode configuration. These parameter changes enable reliable fixation at epicardial sites through minimally invasive delivery, changing the mechanical and electrical characteristics to match the new implantation approach.
3Device complexity
If transvenous lead placement is used, then procedure simplicity is maintained, but skill requirements increase due to small size and tortuosity of cardiac veins
Solution Approach 1:
Instead of navigating complex tortuous veins from the inside out, the inverted approach delivers the lead from the outside in through the epicardial surface. This reverses the traditional transvenous navigation challenge into a simpler external access problem, reducing skill requirements while maintaining procedure simplicity.
Solution Approach 2:
The delivery catheter serves as an intermediary that simplifies the complex task of epicardial lead placement. By using suction to create negative pressure and guide the lead into position, the catheter mediates between the operator and the complex anatomical structures, reducing the skill level required for successful implantation.
4Reliability
If epicardial lead fixation is achieved, then lead stability is improved, but device complexity increases due to stabilization members and anchoring requirements
Solution Approach 1:
The lead features localized quality variations: a longer helical tip electrode at the distal end for deep tissue engagement and a flexible anode configuration at the proximal end for epicardial contact. This local differentiation provides reliable fixation through tissue interlocking without requiring complex external stabilization members or anchoring structures.
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 solution enables reliable fixation of the lead in epicardial locations with improved electrical performance and reduced risk of dislodgement, while minimizing invasiveness and skill requirements for implantation, allowing for more effective cardiac stimulation therapies.
Implementation Method 1
A suction device is provided at the distal end of the outer catheter for holding the outer catheter in place on the epicardial surface
Implementation Method 2
The helical tip electrode is advanced into the myocardium by rotational forces applied to the proximal lead body end
Implementation Method 3
A flexible anode electrode is provided which contacts the epicardial surface when the lead is implanted
Data Source
AI summary
A medical electrical lead having an elongated lead body extending from a proximal end to a distal end, a first electrode positioned at the distal end of the lead body, a second electrode spaced proximally from the first electrode, the second electrode being a flexible conductive coil and having a distal end. A first electrode sleeve is coupled to the first electrode, and a second electrode sleeve is coupled to the second electrode and positioned within the proximal end of the lead body and proximal the distal end of the second electrode to provide flexibility in a distal lead body portion.