Open Channel Implant Tool for Extravascular ICD Lead Placement
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Solution Overview
Problem
Traditional implantable cardiac defibrillator (ICD) systems with transvenous leads face challenges in patients with difficult vascular access and may require complex lead revision procedures due to fibrosis, making extravascular ICD systems a preferable alternative for implanting leads outside the heart.
Innovation Solution
Development of implant tools with a handle and shaft featuring open channels and lumens for fluid delivery, allowing for the implantation of medical leads in subcutaneous or substernal locations, along with a sheath to facilitate the placement of fluid delivery tubes and other structures, enabling efficient and precise placement of extravascular ICD systems.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If transvenous leads are implanted within the heart, then electrical therapy delivery is achieved, but vascular access difficulty and lead fibrosis complications occur
Solution Approach 1:
The patent extracts the lead implantation from the venous system and heart, placing it entirely in the subcutaneous tissue. The shaft creates a subcutaneous pocket and tunnel, delivering the lead without requiring venous access, thereby eliminating the vascular access difficulty while maintaining reliable lead placement
Solution Approach 2:
The patent introduces a shaft as an intermediary device that facilitates lead delivery through subcutaneous tissue. The shaft with its open channel acts as a mediator between the implantation site and the lead, enabling precise placement without direct venous access or heart penetration
2Reliability
If transvenous leads are implanted within the heart, then electrical therapy delivery is achieved, but lead revision and extraction become challenging due to fibrosis
Solution Approach 1:
By extracting the lead implantation from the heart environment, the patent eliminates the fibrosis problem that occurs with chronic lead presence in cardiac tissue. The subcutaneous location prevents fibrosis formation, making future revisions and extractions significantly easier while maintaining electrical therapy delivery capability
Solution Approach 2:
The patent inverts the traditional implantation approach by placing the lead in subcutaneous tissue rather than within the heart. This reversal of the implantation location eliminates the fibrosis issue that plagues transvenous leads, thereby improving ease of repair and extraction
3Ease of operation
If extravascular ICD systems are implemented, then vascular access requirements are eliminated, but implant tool complexity increases
Solution Approach 1:
The patent segments the implant tool into distinct functional components: a shaft with an open channel for lead delivery, a separate delivery device for fluid injection, and a coupling mechanism. This segmentation allows each component to perform its specific function efficiently, managing the overall complexity through modular design
Solution Approach 2:
The shaft serves multiple functions: it creates the subcutaneous pocket, forms the tunnel for lead delivery, and provides structural support. The open channel within the shaft universally accommodates different lead types and sizes. This multi-functionality reduces the number of separate devices needed, managing complexity while achieving the goal of eliminating vascular access requirements
Data Source
AI summary
This disclosure provides various embodiments of implant tools and implant techniques utilizing those tools. In one embodiment, an implant tool comprises a handle and a shaft. The shaft includes a proximal end adjacent the handle, a distal end, an open channel that extends from near the proximal end to the distal end, and at least one lumen that extends from a proximal end of the shaft to a location near the distal end of the shaft. The implant tool may also include a coupler configured to connect to a fluid delivery device. In one example, the fluid delivery device may be a syringe. In some instances, the handle of the implant tool may include a compartment or a recess configured to receive the fluid delivery device.