Split-Distal Electrical Leads With Blunt-Ramp Delivery
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Solution Overview
Problem
Existing implantable leads for cardiac pacing and defibrillation often require invasive procedures that risk damage to critical tissues and vessels, and there is a need for improved methods and systems to facilitate safer and more precise insertion.
Innovation Solution
The development of electrical leads with split distal portions that can be implanted in multiple directions, combined with a delivery system featuring blunt tips and ramps to minimize tissue damage, allowing for extravascular placement in regions like the cardiac notch, and a computer program for optimizing electrode placement.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If traditional invasive lead insertion methods are used, then reliable electrical connection to the heart is achieved, but risk of damage to critical tissues and vessels increases
Solution Approach 1:
The lead is divided into a proximal portion and a distal portion that can be separated. The distal portion with electrodes can be independently positioned in the cardiac notch, allowing the sharp penetrating tip to be discarded after initial insertion, thereby reducing long-term tissue damage risk while maintaining reliable electrical connection.
Solution Approach 2:
The sharp penetrating tip is extracted from the final implant configuration. After the distal portion is inserted through the intercostal space, the sharp tip is removed and the distal portion is deployed, leaving only the biocompatible electrode structure in place. This eliminates the ongoing harmful effect of the sharp tip while preserving its useful function during insertion.
2Manufacturing precision
If precise electrode positioning is achieved through complex delivery systems, then therapeutic efficacy is improved, but device complexity increases
Solution Approach 1:
The delivery system employs dynamic, movable insertion tips that can be adjusted during the procedure. The tips can be repositioned and oriented to match the specific anatomy of the cardiac notch, providing precise electrode placement without requiring a completely complex fixed mechanism. The system adapts to patient-specific variations through operator control.
Solution Approach 2:
The delivery system acts as an intermediary tool that facilitates precise positioning without becoming part of the final implant. The complex mechanism is temporary and is removed after deployment, allowing high positioning precision without permanently increasing device complexity. The system provides controlled release of the distal portion at the precise location.
3Object-affected harmful factors
If blunt tips and ramps are used to minimize tissue damage, then safety is improved, but insertion difficulty increases
Solution Approach 1:
The sharp penetrating tip performs the preliminary action of penetrating the intercostal space and reaching the cardiac notch. Once this initial barrier is overcome, the blunt tip and ramp structures take over to minimize further tissue damage during final positioning. This sequence allows effective insertion while maintaining tissue safety during the prolonged implantation process.
Solution Approach 2:
The insertion tips are designed to be movable and adjustable rather than fixed. This dynamic capability allows the operator to optimize the insertion path and angle in real-time, compensating for the reduced penetrating power of blunt tips. The ramps can be adjusted to facilitate smooth passage through tissue planes, maintaining ease of operation while minimizing damage.
Data Source
AI summary
Disclosed is a delivery system for a component, for example, a splitting lead. A splitting lead can have a proximal portion to engage a controller and a distal portion to split apart into sub-portions that travel in multiple directions during implantation into a patient. The delivery system can include a handle and a component advancer to advance and removably engage a portion of the component. The component advancer can be coupled to the handle and advance the component into the patient by applying a force to the portion in response to actuation of the handle by the operator. Also, the delivery system can include an insertion tip with first and second ramps to facilitate advancement of first and second sub-portions into the patient in first and second directions. The leads may have various electrode configurations including, for example, wrapped or embedded electrodes, helical or elliptical coils, thin metallic plates, etc.