Steerable Introducer Assembly for Minimally Invasive Electrode Placement
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Solution Overview
Problem
Existing medical electrode arrays require large incisions for implantation, causing tissue trauma and limiting the precision of current flow distribution for therapeutic effects.
Innovation Solution
A system for percutaneously inserting and deploying an implantable medical device, such as an electrode array, using a core and sheath assembly with a handpiece that includes steering and retraction mechanisms to position and unfold the array through a small portal, allowing precise placement and minimally invasive procedures.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Manufacturing precision
If a large incision is made to position the electrode array, then the array can be properly positioned against the target tissue, but tissue trauma increases and the procedure becomes more invasive
Solution Approach 1:
The electrode array is divided into multiple segments that can be independently positioned and secured. The array includes a first portion and a second portion that can be deployed separately through the same incision, allowing precise positioning without requiring a larger initial incision.
Solution Approach 2:
A guide wire is introduced through the incision to serve as an intermediary tool for positioning the electrode array. The guide wire provides a pathway and reference for accurately placing the array against the target tissue through the limited incision size, enabling precise positioning without requiring a large incision.
2Measurement precision
If the electrode array is made with numerous individual electrodes occupying large surface area, then current flow can be distributed more precisely for therapeutic effects, but the incision size must be increased to accommodate the array
Solution Approach 1:
The array is segmented into multiple electrode elements that can be distributed along the array structure. This allows numerous electrodes to provide precise current flow distribution while the segmented design enables compact packaging that fits through a smaller incision.
Solution Approach 2:
The electrode array is designed to be folded or rolled into a compact configuration that can be inserted through the incision. The array can be deployed in a telescoping or unfolding manner, with portions nested within each other during insertion, allowing the full array to be delivered through a limited incision size.
3Ease of operation
If tissue is removed to access the target tissue, then the electrode array can be positioned, but the procedure complexity and trauma increase
Solution Approach 1:
The guide wire acts as an intermediary that simplifies the positioning process. By inserting the guide wire first through the incision, the surgeon can use it as a reference and pathway to position the electrode array without needing to perform complex tissue dissection or removal, reducing procedure complexity.
Solution Approach 2:
The guide wire is inserted and positioned in advance through the incision to establish a pathway and reference for subsequent array placement. This preliminary action simplifies the overall procedure by preparing the access route before the array insertion, eliminating the need for complex intraoperative tissue manipulation.
Data Source
AI summary
An assembly for both targeting a location in a living being at which an implantable medical device is to be inserted and defining a percutaneous path to the target location. The assembly includes a guidewire with electrodes that is inserted percutaneously into the living being. Electrodes on the guidewire source and sink current to facilitate the identification of the target location. A dilator encased in a reinforced sleeve is disposed over the guidewire. Steering wires in the sleeve facilitate the advancement of the sleeve and the guidewire. Once the dilator and sleeve are advanced to the target location, the dilator is removed from the sleeve. The lumen in sleeve functions as the lumen in the living being through which the implantable device is delivered to the target location.