Stimulation Lead Introducer for Single-Insertion Testing and Deployment
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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 lack efficient lead positioning and deployment capabilities, often necessitating multiple needle insertions and limiting lead repositioning during insertion.
Innovation Solution
A single introducer system with a needle assembly and inner deployment mechanism allows for test stimulation, repositioning of the lead, and safe, minimally-invasive deployment of electrodes, incorporating a stimulation electrode with a bent anchor portion and a quick disconnection mechanism for easy adjustment and secure anchoring.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Productivity
If conventional systems use separate test needle and introducer/electrode procedures, then lead deployment can be achieved, but procedural time increases and patient invasiveness worsens
Solution Approach 1:
The patent combines the test needle and introducer/electrode deployment into a single integrated device. The test electrode is positioned on the outer sheath while the stimulation lead is carried within the inner needle, allowing both testing and deployment functions to be performed through one insertion procedure, thereby reducing procedural time and patient invasiveness.
Solution Approach 2:
The single handheld device performs multiple functions: it serves as both a test needle for delivering test stimulation and as an introducer for deploying the stimulation lead. The outer sheath with test electrode and inner needle with stimulation lead work together to provide comprehensive functionality in one device, eliminating the need for separate procedures.
2Ease of operation
If conventional systems require two separate needle insertions for testing and deployment, then lead positioning can be achieved, but procedural complexity increases
Solution Approach 1:
The invention merges the testing function and deployment function into a single integrated device structure. The outer sheath contains the test electrode while the inner needle carries the stimulation lead, allowing both functions to be executed through one insertion procedure, thereby simplifying the overall procedure.
3Adaptability or versatility
If the lead is carried within a single needle and deployed by expelling, then deployment is achieved, but lead repositioning capability is limited
Solution Approach 1:
The invention makes the lead positioning dynamic by allowing the inner needle to be independently advanced or retracted relative to the outer sheath. This independent movement capability enables the operator to adjust the lead position within the tissue before final deployment, providing flexibility and adaptability that was not possible with fixed single-needle systems.
4Productivity
If existing systems lack integrated positioning and deployment, then separate functions can be performed, but overall system efficiency decreases
Solution Approach 1:
The patent merges positioning and deployment functions into a single integrated device. The outer sheath with test electrode enables positioning verification while the inner needle with stimulation lead enables deployment, all through one device and one insertion procedure, thereby eliminating the time loss associated with transitioning between separate devices.
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.