Handheld Stimulation Lead Delivery Device with Integrated Test Needle
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Solution Overview
Problem
Existing electrical stimulation systems for pain relief and other medical uses are inefficient, invasive, require extensive training, and often result in suboptimal efficacy and safety, with limitations in lead positioning and deployment, particularly due to the need for multiple needle insertions and difficulty in repositioning leads after deployment.
Innovation Solution
A handheld device with a needle assembly and inner deployment mechanism that allows for test stimulation and repositioning of a coiled or helical stimulation electrode, enabling safe and minimally invasive delivery of electrical stimulation leads, featuring a quick disconnection mechanism and adjustable positioning block for precise lead placement.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If conventional systems use two separate procedures (test needle and introducer/electrical lead), then test stimulation 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, allowing both test stimulation and lead deployment to occur through one needle insertion procedure, eliminating the need for separate insertions and reducing procedure time.
Solution Approach 2:
The introducer needle serves multiple functions: it acts as both the test needle for delivering test stimulation and as the introducer for deploying the electrical lead. This multi-functional design eliminates the need for separate specialized devices for each function.
2Ease of manufacture
If conventional systems expel the lead out of the open end of the needle, then lead deployment is simple, but the ability to adjust the positioning of the lead is quite limited due to the fragile nature of the lead
Solution Approach 1:
The patent incorporates a dynamic adjustment mechanism that allows the lead position to be modified after deployment. The adjustable positioning block enables clinicians to reposition the lead along the needle shaft, providing flexibility to optimize lead placement without requiring complete removal and reinsertion, thus protecting the fragile lead while enabling adjustment.
Solution Approach 2:
The device is segmented into adjustable components, with the positioning block able to move independently along the needle shaft. This segmentation allows the lead position to be adjusted in discrete steps, providing precise control over lead placement while maintaining the integrity of the lead structure.
3Device complexity
If conventional systems use a single needle for both test stimulation and lead deployment, then the procedure is simpler, but clinicians cannot view which direction the lead anchor is facing, reducing deployment efficiency
Solution Approach 1:
The patent incorporates visual indicators (such as colored markers or radiopaque elements) on the lead anchor and positioning block that allow clinicians to observe the orientation and direction of the anchor during the procedure. These visual cues enable efficient deployment by allowing real-time verification of anchor orientation without requiring additional imaging equipment.
4Reliability
If conventional systems require extensive training and skill to use, then device performance may be improved, but the systems become too complex for widespread use in patients and clinical settings
Solution Approach 1:
The device incorporates self-aligning and self-adjusting features that reduce the skill level required for operation. The adjustable positioning block automatically maintains proper orientation, and the integrated design self-verifies correct placement through visual indicators, allowing less experienced clinicians to achieve reliable results without extensive specialized training.
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.