Stimulation Lead Deployment Device with Integrated Test Needle
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Solution Overview
Problem
Existing electrical stimulation systems for pain relief and medical treatments are inefficient, invasive, require extensive training, and lack the ability to safely and effectively deploy leads for therapeutic purposes, particularly due to the need for multiple needle insertions and limited lead repositioning capabilities.
Innovation Solution
A handheld device with a needle assembly and inner deployment mechanism that allows for test stimulation and repositioning of electrodes, featuring a coiled or helical structure with a biosorbable anchor for secure tissue integration and minimally invasive lead deployment, enabling easy placement and adjustment of electrodes within the body.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Productivity
If conventional systems use two separate procedures (test needle then introducer/electrical lead), then testing and deployment can be performed, but the procedure becomes inefficient and time consuming requiring two separate needle insertions
Solution Approach 1:
The patent combines the test needle and introducer/electrical lead into a single integrated device. The test electrode is positioned on the introducer needle itself, allowing both testing and lead deployment to occur through one needle insertion procedure, thereby eliminating the need for two separate insertions and reducing procedure time.
Solution Approach 2:
The introducer needle serves multiple functions: it acts as both the test needle for initial stimulation testing and as the introducer for deploying the electrical lead. This multi-functional design consolidates what were previously separate tools into one universal device, improving procedural efficiency.
2Ease of operation
If conventional systems rely on carrying the lead within a single needle and deploying by expelling, then deployment is simplified, but the ability to adjust lead positioning is limited due to the fragile nature of the lead
Solution Approach 1:
The patent enables dynamic adjustment of lead positioning after deployment. The system allows the lead to be repositioned along the needle shaft both before and after deployment, providing adaptability while maintaining ease of operation. This dynamic capability addresses the limitation of fixed positioning in conventional single-needle systems.
Solution Approach 2:
The introducer needle acts as an intermediary that facilitates both the simple deployment and subsequent repositioning of the lead. By maintaining the lead's attachment to the needle structure, the system provides a mechanism for adjustment that wouldn't be possible with simple expulsion methods, while still preserving deployment simplicity.
3Reliability
If conventional systems require clinicians to view lead anchor direction after insertion, then deployment effectiveness can be assessed, but the system lacks integrated visualization capability requiring additional equipment
Solution Approach 1:
The patent integrates visualization capability directly into the introducer needle by incorporating markings or indicators on the needle shaft that show the direction the lead anchor is facing. This merging of visualization function into the existing device structure allows deployment assessment without adding separate complex equipment, maintaining reliability while controlling system 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. The outer sheath 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 the outer sheath.