Lead Introducer System Single-Handed Deployment
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Solution Overview
Problem
Existing systems for electrode lead deployment in electrical stimulation systems are inefficient, invasive, require extensive training, and often result in suboptimal efficacy and safety, with limitations in repositioning and single-handed operation.
Innovation Solution
A lead introducer system with a housing, external and intermediate sheaths, and an inner sheath that allows for single-handed deployment and retraction of the lead, enabling precise positioning and anchoring within tissue with minimal invasiveness and reduced procedural complexity.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Productivity
If conventional two-step electrode deployment systems are used, then lead positioning capability is provided, but procedural efficiency is reduced and patient invasiveness increases
Solution Approach 1:
The patent combines test needle functionality and lead introducer functionality into a single integrated device. The outer sheath serves as both the test needle and the lead introducer, eliminating the need for separate devices and reducing the number of needle insertions required.
Solution Approach 2:
The outer sheath is designed to perform multiple functions: it serves as a test needle for initial tissue assessment, as a delivery mechanism for the inner sheath and lead, and as a guide for precise lead placement. This multi-functional design streamlines the procedure and reduces invasiveness.
2Reliability
If extensive training is required for lead deployment, then device capability is comprehensive, but ease of operation deteriorates
Solution Approach 1:
The device incorporates self-aligning and self-contained features that reduce the need for complex manual manipulation. The inner sheath automatically positions within the outer sheath, and the lead deployment mechanism is designed to function with minimal user intervention, reducing training requirements.
3Measurement precision
If lead repositioning capability is limited, then device simplicity is maintained, but positioning precision deteriorates
Solution Approach 1:
The device allows dynamic adjustment of lead position during the procedure. The inner sheath can be repositioned within the outer sheath before final lead deployment, enabling clinicians to optimize lead positioning without requiring device retraction or complex repositioning maneuvers.
4Measurement precision
If two-handed operation is required, then control precision is improved, but ease of operation deteriorates
Solution Approach 1:
The patent extracts the functions that would require a second hand from the deployment process. The device is designed with self-contained mechanisms that automatically perform functions such as inner sheath advancement and lead deployment, allowing the procedure to be completed with single-handed operation.
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.