Single Incision Subcutaneous Defibrillator Lead Tunneling Tool
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Solution Overview
Problem
The existing subcutaneous-only defibrillator implantation methods require multiple incisions, which can lead to complications such as infection and aesthetic concerns, and there is a need for a minimally invasive technique to reduce the number of incisions while ensuring effective implantation of the defibrillation lead.
Innovation Solution
A tunneling tool and lead assembly kit that includes a handle with a curved elongate shaft and fixation elements, allowing for a single incision implantation by tunneling parallel to the sternum, with a distal dissecting element to facilitate tissue dissection and secure fixation of the lead assembly to the tissue without additional incisions.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If multiple incisions are used for implantation, then the lead assembly can be effectively implanted and fixedated to the tissue, but the risk of infection and poor cosmetic outcomes increases
Solution Approach 1:
The implantation procedure is segmented into distinct functional components: a tunneling tool for creating the subcutaneous tunnel, a lead assembly with separate fixation elements (helical expandable anchors), and a dissecting element. This segmentation allows each component to perform its specific function efficiently while reducing the need for multiple incisions.
Solution Approach 2:
The tunneling tool serves as an intermediary device that creates a subcutaneous tunnel from a single incision site, allowing the lead assembly to be delivered without requiring additional incisions. The helical expandable anchors act as intermediaries to secure the lead assembly to the tissue within the tunnel, providing stable fixation without external sutures or additional incisions.
2Object-affected harmful factors
If a single incision is used for implantation, then infection risk and cosmetic outcomes are improved, but the difficulty of lead assembly implantation and fixation increases
Solution Approach 1:
The tunneling tool is used to preliminarily create a subcutaneous tunnel and dissect tissue along the desired lead path before the lead assembly is delivered. The helical expandable anchors are preliminarily positioned within the tunnel, allowing for controlled expansion and fixation after lead delivery, simplifying the overall single-incision procedure.
Solution Approach 2:
The tunneling tool features a curved shaft that follows the natural subcutaneous tissue planes, allowing easy navigation from the incision site to the target implantation location. The helical shape of the expandable anchors provides mechanical advantage for anchoring to the tissue, enabling secure fixation through rotational expansion within the confined single-incision access.
3Ease of operation
If multiple incisions are used, then adequate access for lead placement is achieved, but implantation time and procedural complexity increase
Solution Approach 1:
The tunneling tool and lead assembly delivery are merged into a single integrated procedure through the single incision access. The expandable anchors are combined with the lead assembly, eliminating the need for separate fixation procedures. This merging of functions into a single procedural pathway significantly reduces implantation time compared to multiple-incision approaches.
Data Source
AI summary
Methods and tool kits for implanting a lead subcutaneously. Examples include tool kits and methods for establishing first and second subcutaneous tunnels at an angle relative to one another to facilitate introduction of a lead to the subcutaneous space. In an example, a tunneling tool and lead assembly are advanced simultaneously into the subcutaneous space. The tunneling tool may include a curved region configured to transition the tool from the first subcutaneous tunnel to the second subcutaneous tunnel with the use of a single incision.