Detachable Active Agent Delivery Stylet for Cardiac Lead Repositioning
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Solution Overview
Problem
Conventional implantable cardiac rhythm management devices face challenges in consistently delivering active agents to implantation sites, requiring full removal and replacement of leads for MCRD replenishment or repositioning, which is invasive and inefficient.
Innovation Solution
A system and method involving a delivery stylet with an active agent delivery component that can be inserted through the lead lumen to directly implant the agent at the site, allowing for additional agent delivery without removing the lead, and enabling lead repositioning with reduced rigid length for improved maneuverability.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Ease of operation
If a conventional lead with MCRD is used, then the lead can deliver active agents to the implantation site, but the lead must be fully removed and replaced for MCRD replenishment or repositioning
Solution Approach 1:
The delivery stylet with detachable MCRD is inserted through the lead lumen, nesting the delivery system within the existing lead structure. This allows MCRD replenishment and repositioning without removing the lead itself, resolving the contradiction by enabling access to the implantation site through the lead's internal pathway.
Solution Approach 2:
The delivery stylet is designed as a separate, detachable component that can be independently inserted and removed through the lead lumen. This segmentation allows the MCRD to be replenished or repositioned without affecting the permanent lead structure, eliminating the need for full lead removal and replacement.
2Manufacturing precision
If the lead is made more flexible for better maneuverability, then lead placement accuracy improves, but the lead structure becomes more complex
Solution Approach 1:
The delivery stylet features a flexible distal portion that can be advanced through the lead lumen and manipulated at the implantation site. This flexible component enables precise lead placement and MCRD positioning without requiring the entire lead structure to be complex or highly flexible, resolving the contradiction by localizing the flexibility where needed.
3Manufacturing precision
If the delivery stylet is made rigid for stable MCRD delivery, then delivery precision improves, but the stylet cannot navigate through the lead lumen effectively
Solution Approach 1:
The delivery stylet transitions from a flexible state during insertion (navigating the lead lumen) to a more rigid state during MCRD delivery and deployment. The distal portion can be advanced through the lumen in a flexible manner, then used to push the MCRD with sufficient force for precise delivery, resolving the contradiction by allowing the stylet to exhibit different mechanical properties at different stages of the procedure.
Data Source
AI summary
Delivery of implantable active agent delivery components includes implanting a distal lead end of a lead into tissue at an implantation site. A delivery stylet is then inserted through a lead lumen of the lead. The delivery stylet includes a stylet body having a distal stylet end and an active agent delivery component detachably coupled to the distal stylet end. The active agent delivery component is inserted into the tissue at the implantation site by extending the distal stylet end of the delivery stylet from a distal lead end of the lead such that the active agent delivery component is inserted into the tissue at the implantation site. The active agent delivery component is then detached within the tissue at the implantation site and the delivery stylet may be retracted and removed from the lead lumen.