Lead Introducer System with Nested Sheaths for Single-Step Implantation
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Solution Overview
Problem
Existing systems for electrode deployment or implantation in electrical stimulation systems are inefficient, time-consuming, and invasive, requiring extensive training and often resulting in poor device performance, suboptimal efficacy, and safety concerns.
Innovation Solution
A lead introducer system comprising a housing, external and intermediate sheaths, and an inner sheath configured to hold a lead, with an actuator biasingly engaged with the sheaths to deploy the lead into tissue and anchor it, allowing for test stimulation and repositioning.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Productivity
If conventional two-step electrode deployment systems are used, then the lead can be deployed into tissue, but the procedure becomes inefficient and time-consuming requiring two separate needle insertions
Solution Approach 1:
The patent combines test needle and lead introducer functions into a single integrated device. The introducer needle contains both the lead and test electrodes within its structure, allowing clinicians to perform test stimulation and deploy the lead in one continuous procedure rather than requiring separate insertion steps for test needle and introducer.
Solution Approach 2:
The introducer needle serves multiple functions simultaneously: it acts as the delivery vehicle for the lead, contains test electrodes for stimulation testing, and provides structural support during deployment. This multi-functional design eliminates the need for separate test needle and introducer devices.
2Ease of operation
If the lead is carried within a single needle, then the deployment is simplified, but the ability to adjust lead positioning is limited due to the fragile nature of the lead
Solution Approach 1:
The lead is nested within the introducer needle, which provides rigid structural support. The needle acts as a protective sheath that maintains lead positioning and allows for adjustment without compromising lead integrity. The test electrodes are also nested within the needle structure, enabling testing while the lead remains protected.
Solution Approach 2:
The introducer needle serves as an intermediary structure between the operator and the fragile lead. It provides the mechanical strength needed for positioning and adjustment, while the lead itself remains protected within the needle until deployment is complete.
3Reliability
If existing deployment systems are used, then the lead can be inserted, but extensive training and skill are required resulting in poor device performance and safety concerns
Solution Approach 1:
The test electrodes are pre-positioned within the introducer needle at specific locations. This allows clinicians to perform test stimulation before lead deployment to confirm proper positioning and functionality, reducing the risk of improper placement and improving overall device performance and safety.
4Loss of time
If a single handheld device is used for positioning and deployment, then the procedure time is reduced, but the device complexity increases with multiple sheaths and actuators
Solution Approach 1:
The introducer device is segmented into distinct functional components: external sheath, intermediate sheath, inner sheath, and actuator mechanisms. Each segment performs a specific function in the deployment sequence, allowing for systematic operation that reduces procedure time despite the increased structural complexity.
Data Source
AI summary
An introducing device for locating a tissue region and deploying an electrode is shown and described. The introducing device may include an outer sheath. An inner sheath may be disposed within the outer sheath. The inner sheath may be configured to engage an implantable electrode. In an example, the inner sheath may comprise a stimulation probe having an uninsulated portion at or near a distal end of the delivery sheath. A sheath or needle may be coupled to a power source or stimulation signal generating circuitry at a proximal end. A clinician may control application of the stimulation signal to a tissue region via a sheath or needle.