Substernal Lead Delivery with Biased Needle for Precise Placement
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Solution Overview
Problem
Traditional transvenous lead delivery methods for implantable devices result in complications such as increased pacing thresholds, tissue damage, and misclassification of cardiac signals, limiting the effectiveness of implantable devices in treating cardiac conditions.
Innovation Solution
A system and method for delivering a lead using a needle with a biased portion, a stylet, a guidewire, and a sheath to position the lead in the substernal space, allowing for precise placement and reduced tissue damage, while enabling accurate signal detection and treatment delivery.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Ease of operation
If transvenous lead delivery is used, then leads can be delivered into the heart, but lead-related patient complications and tissue damage occur
Solution Approach 1:
The patent inverts the traditional transvenous approach by delivering leads through a subcutaneous route instead of through veins. The lead delivery system penetrates the skin and delivers the lead directly into the heart tissue from the outside, avoiding venous traversal and associated tissue damage while maintaining lead delivery capability
Solution Approach 2:
The patent introduces a specialized lead delivery system as an intermediary device that facilitates lead placement through the subcutaneous route. This delivery system includes a can, lead, and positioning mechanisms that mediate between the external environment and the heart, enabling safe lead insertion without direct venous penetration
2Object-affected harmful factors
If leads are placed external to the heart, then tissue damage is reduced, but pacing thresholds increase
Solution Approach 1:
The patent applies local quality by creating a localized subcutaneous pocket directly overlying the heart where the lead is placed. This localized approach allows the lead to be external to the heart chambers while maintaining close proximity to cardiac tissue, thereby reducing overall tissue damage while preserving effective pacing thresholds through optimal positioning
3Object-affected harmful factors
If epicardial or subcutaneous leads are used, then lead-related complications are reduced, but discrimination of true cardiac states becomes challenging
Solution Approach 1:
The patent incorporates feedback mechanisms where the implantable pulse generator continuously monitors cardiac signals from the subcutaneous lead and adjusts pacing parameters accordingly. This feedback loop enables the system to distinguish between true cardiac events and artifacts, improving signal discrimination accuracy while maintaining the benefits of subcutaneous lead placement
Data Source
AI summary
A system for delivering a lead an implantable diagnostic/treatment device includes a needle defining a needle lumen and including a biased portion. The biased portion is configured to bias at least a distal end portion of the needle toward a posterior sternal wall when disposed in a body of a patient. The system includes a stylet removably coupled to the needle that is configured to selectively straighten the biased portion of the needle for insertion into the body of the patient. The system includes a guidewire configured to extend through the needle lumen and into the substernal space. The system includes a sheath configured to be advanced over the guidewire to dispose a distal end of the sheath in the substernal space. The sheath defines a sheath lumen allowing the lead to be advanced therethrough to deliver the lead to a substernal space in the body of the patient.