Fixation Device for S-ICD Lead via Single Incision
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Solution Overview
Problem
The subcutaneous implantable cardioverter-defibrillator (S-ICD) system faces challenges in lead fixation and implantation, particularly concerning infection risk and cosmetic outcomes due to the number of incisions required, and there is a need for innovative methods to simplify the implant procedure and enhance lead security.
Innovation Solution
A tool and method for placing a fixation device on a lead, featuring a tool with a tapered portion to expand the fixation device lumen, allowing secure placement on the lead, combined with a fixation device having securing mechanisms that can expand to anchor the lead in tissue, reducing the need for multiple incisions and improving fixation.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If multiple incisions are used for lead implantation, then lead fixation and implantation access are improved, but infection risk increases and cosmetic outcomes worsen
Solution Approach 1:
A fixation device with a body and securing mechanisms serves as an intermediary component between the lead and the tissue. The device is advanced over the lead through a single incision and then deployed to anchor the lead, eliminating the need for multiple incisions while maintaining secure fixation. The securing mechanisms (such as hooks or tines) engage with the tissue to provide reliable anchoring through the single-access approach.
2Reliability
If multiple incisions are used for lead implantation, then lead fixation and implantation access are improved, but cosmetic outcomes worsen
Solution Approach 1:
The fixation device acts as a mediator that enables secure lead anchoring through a single incision approach. By advancing the fixation device over the lead and deploying its securing mechanisms within the tissue, the system achieves reliable fixation without requiring multiple surgical incisions, thereby improving cosmetic outcomes by minimizing visible scarring.
3Reliability
If fixation device lumen is smaller than lead distal tip outer diameter, then secure anchoring is improved, but device placement difficulty increases
Solution Approach 1:
The fixation device incorporates a dynamic expansion mechanism where the body transitions from a compressed state during delivery to an expanded state at the implantation site. The securing mechanisms are initially constrained in a low-profile configuration that allows easy advancement over the lead, then deployed to engage with the tissue and provide secure anchoring. This dynamic transformation resolves the contradiction between ease of placement and secure anchoring.
Solution Approach 2:
The fixation device is designed with a nested structure where the securing mechanisms are contained within the body during delivery. The device is advanced over the lead in a compact, nested configuration, then deployed by extending the securing mechanisms from the body to engage with the surrounding tissue, achieving secure anchoring while maintaining ease of placement.
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
This solution simplifies the implant procedure, reduces the risk of infection, enhances lead fixation, and improves cosmetic outcomes by minimizing the number of incisions required, while providing stable anchoring of the lead in the subcutaneous tissue.
Implementation Method 1
the body having an outer surface with a tapered portion that expands from a third tool outer diameter that is less than the inner diameter of the fixation device lumen to the second tool outer diameter
Data Source
AI summary
Tools adapted to allow a fixation device to be applied near the distal end of an implantable lead, and methods for using such tools. Preparing the lead for implantation may be performed by placing a tool over a distal tip of the lead, moving a fixation device from the tool to the lead, and placing the fixation device the lead.