Implantable Lead Extension Kit for Sterile Trial Management
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Solution Overview
Problem
The existing implantation procedures for implantable lead extensions in stimulation therapy are inefficient due to the need for external leads and tools, which introduce additional burdens and inefficiencies, particularly in accessing and managing the length of the lead extension and tools during the trial period.
Innovation Solution
A kit that includes a body with attached implantable medical lead extension, allowing for secure storage and organization of excess length, direct attachment to the patient, and integration of tools like tunneling and pull-through tips, enabling efficient implantation and management of the lead extension within a sterile field.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Length of moving object
If an external lead is used to connect the implantable lead extension to the external device, then the lead extension can be shorter and less burdensome during implantation, but the external lead introduces additional burden of installation and maintenance during the trial period
Solution Approach 1:
The patent combines the implantable lead extension with the external lead into a single integrated assembly. The external lead is coupled to the proximal end of the implantable lead extension, creating a unified device that eliminates the need for separate installation and maintenance of distinct components during the trial period.
Solution Approach 2:
The integrated assembly serves multiple functions: the implantable lead extension provides subcutaneous routing and electrical connection to the stimulation site, while the external lead provides connection to the external stimulator. This multi-functional design allows the single device to replace what would otherwise require multiple separate components.
2Ease of manufacture
If tools are packaged outside the sterile field, then packaging and storage is simplified, but a sterile nurse must access tools from packaging and place them on a surgical tray, adding time and inefficiency to the implantation procedure
Solution Approach 1:
The patent combines the tools (tunneling rod, pull-through tip, lead extension, and connectors) into a single integrated kit that can be introduced into the sterile field as one unit. This eliminates the separate steps of packaging, accessing, and transferring tools between non-sterile and sterile fields, allowing the entire assembly to be prepared and sterilized together.
Solution Approach 2:
The tools and lead extension are pre-assembled into the kit configuration before sterilization. The tunneling rod is coupled to the pull-through tip, which is coupled to the lead extension, creating a ready-to-use assembly that requires no additional assembly steps during the implantation procedure once in the sterile field.
3Ease of operation
If excess lead extension is left loose during the trial period, then it remains accessible, but it creates burden and discomfort for the patient
Solution Approach 1:
The patent designs the kit body with a recess that receives and contains the excess lead extension. The lead extension is nested within the kit structure, with the kit body acting as a container that organizes and secures the excess lead length, preventing it from being loose or burdensome to the patient during the trial period.
Solution Approach 2:
The kit body serves as an intermediary structure between the implanted lead extension and the external environment. It provides a mounting surface for the connector and a containment structure for excess lead, mediating the transition from loose lead to organized, patient-friendly configuration.
Data Source
AI summary
Kits provide management of implantable lead extensions being implanted by providing a kit body with features that retain the extension in a configuration, with amounts being removed as needed during the implantation procedure. The kit can be present within a sterile field, and the kit body features may be arranged so that a length of a path that the extension forms is approximately equal to a length of the extension needed for the tunnel. The kit body may include features that allow the connectors of the extension as well as implantation tools to be retained within the kit body while being easily accessed when needed during the procedure. The kit may be coupled to the patient during the trial period, as the extension may have an implanted distal connector while having a proximal connector coupled to an external stimulator and while being retained on the kit body.