Nested Introducer Tool Kit for Single-Incision Subcutaneous Lead Implantation
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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.
Innovation Solution
An introducer tool kit is provided for implanting a subcutaneous lead, which includes a first insertion tool for creating a subcutaneous tunnel and a second insertion tool that can create a tunnel at an angle relative to the first, using a splittable sheath and ultrasonic transducers to facilitate the process, allowing for the potential reduction of incisions to a single site.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If multiple incisions are used for subcutaneous lead implantation, then the lead can be effectively placed and stabilized, but the risk of infection and poor aesthetic outcome increases
Solution Approach 1:
The patent employs nested insertion tools where a second insertion tool is placed inside the first insertion tool. The first tool creates an initial subcutaneous tunnel, and the second tool (with curved configuration) is nested within it to create a second tunnel at an angle. This nesting approach allows complex multi-directional tunneling through a single incision, eliminating the need for multiple separate incisions while maintaining effective lead placement capability.
Solution Approach 2:
The patent introduces angular dimensionality by using a second insertion tool configured to create a subcutaneous tunnel at an angle relative to the first tunnel. The curved configuration of the second tool allows it to branch off from the first tunnel path, creating a three-dimensional tunnel network from a single incision site. This dimensional approach enables complex lead routing without additional skin incisions.
2Reliability
If multiple incisions are used for subcutaneous lead implantation, then the lead can be effectively placed and stabilized, but the aesthetic outcome deteriorates
Solution Approach 1:
The nested insertion tool configuration allows multiple tunnel paths to be created from a single incision site. The first insertion tool establishes the primary tunnel, and the second curved tool is nested within it to create additional angled tunnels. This nesting strategy consolidates multiple access points into one, preserving skin integrity and aesthetic appearance while maintaining comprehensive lead placement capability.
Solution Approach 2:
By utilizing angular and three-dimensional tunneling paths from a single incision, the patent creates a multi-directional subcutaneous network. The curved second insertion tool branches off at an angle from the first tunnel, enabling complex lead routing in three-dimensional space without additional visible incisions, thus improving aesthetic outcome.
3Object-affected harmful factors
If a single incision is used for subcutaneous lead implantation, then infection risk and aesthetic concerns are reduced, but the difficulty of creating angled tunnels increases
Solution Approach 1:
The patent resolves the complexity challenge by using a nested configuration where the second curved insertion tool is placed inside the first insertion tool. This nesting allows the curved tool to be guided through the initial tunnel path and then deployed at an angle, simplifying the operation compared to attempting to create angled tunnels with a single complex tool or multiple separate incisions.
Solution Approach 2:
The first insertion tool is used to create the initial subcutaneous tunnel path before the second curved tool is introduced. This preliminary action establishes a guiding pathway that facilitates the subsequent insertion of the curved tool at the desired angle, breaking down the complex task into sequential, manageable steps from a single incision site.
4Object-affected harmful factors
If a curved insertion tool is used to create angled tunnels, then the number of incisions is reduced, but the precision of tunnel placement becomes more difficult to control
Solution Approach 1:
The nested configuration provides inherent guidance and control. The second curved insertion tool is constrained within the pathway established by the first tool, ensuring precise positioning. The curvature of the second tool is predetermined and controlled, allowing accurate angular placement while maintaining the benefit of a single incision site.
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 approach minimizes the number of incisions required, potentially reducing infection risks and improving the aesthetic outcome by allowing for the implantation of a subcutaneous defibrillation lead with fewer surgical openings, while maintaining effective placement and stability of the lead.
Implementation Method 1
the second insertion tool has a distal end which includes an ultrasonic transducer for using ultrasonic energy to assist in creation of the second subcutaneous tunnel
Data Source
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AI summary
Tool kits for implanting a lead subcutaneously. Examples include tool kits 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 first insertion tool is used to establish a first subcutaneous tunnel, and a second insertion tool, with or without the use of a blunt dissector, sheath, guidewire, or steering mechanism, is used to initiate or form the second subcutaneous tunnel. Such tool kits may reduce the number of incisions needed to implant a subcutaneous lead along a subcutaneous path having a curve therein.