Subcutaneous Lead Connector Plug for Spinal Cord Stimulator
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Solution Overview
Problem
Current spinal cord stimulator systems face challenges in achieving consistent pain relief during permanent lead placement after a successful trial, due to secondary scarring making percutaneous placement difficult, and require invasive surgical procedures for adequate coverage.
Innovation Solution
The method involves using a percutaneously placed electrode lead as both a trial and permanent lead by integrating a subcutaneous lead connector plug with anchor points for secure placement, allowing connection to a generator lead for both trial and extended use periods without the need for a second surgical procedure.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Ease of operation
If a percutaneous lead placement is performed during trial, then the procedure is less invasive and can be performed by pain management physician, but secondary scarring makes it difficult to achieve the same coverage during permanent placement
Solution Approach 1:
The trial lead placement is performed with the intention of reusing the same lead tract for permanent placement. The lead is positioned during trial to map the optimal electrode contacts for pain coverage, and this positioning information is preserved for permanent lead implantation, avoiding the need to navigate through scarred tissue later.
Solution Approach 2:
The same percutaneous lead serves dual purposes: it functions as both the trial lead for testing pain coverage and as the permanent lead for long-term pain management. This eliminates the need for separate trial and permanent lead placement procedures.
2Reliability
If a paddle lead placement is performed to improve coverage, then the likelihood of finding good coverage is improved, but the procedure requires invasive surgical opening of the spinal canal
Solution Approach 1:
The trial period allows identification of the optimal number and positioning of percutaneous leads needed to achieve adequate pain coverage. This preliminary mapping eliminates the need for more invasive paddle lead placement by determining that fewer, strategically positioned percutaneous leads are sufficient.
Solution Approach 2:
Instead of using invasive paddle leads to achieve coverage and then hoping percutaneous leads would work, the approach is inverted: percutaneous leads are used first during trial to demonstrate that they can achieve adequate coverage, thereby avoiding the need for invasive permanent placement.
3Ease of operation
If percutaneous lead placement is attempted during permanent placement, then the procedure is less invasive, but it is difficult to achieve the same coverage as trial due to secondary scarring
Solution Approach 1:
The trial lead placement establishes the precise positioning and orientation of the lead within the epidural space. This preliminary positioning data is used to guide permanent lead placement through the same tract, ensuring reproducible positioning despite the presence of scar tissue.
Solution Approach 2:
The permanent lead placement replicates the trial lead configuration by using the same number of leads, electrode contacts, and spatial arrangement. This copying of the successful trial configuration ensures consistent pain coverage while maintaining the less invasive percutaneous approach.
Data Source
AI summary
A method may include, using an electrode lead(s) having a proximal end and a distal end and comprising spaced apart electrodes carried by the distal end, positioning the electrodes adjacent nerves in a patient; using a subcutaneous lead connector plug comprising a housing electrically connected to the proximal end of the electrode lead(s) and defining a lead connection port(s) and an anchor point(s), positioning the housing along with the proximal end of the electrode lead(s) inside the patient; connecting the anchor point(s) to tissue beneath the patient's skin and, using a first generator lead having a distal end and a proximal end, plugging the distal end of the first generator lead into the lead connector port(s); and connecting the proximal end of the first generator lead to a first neural stimulation generator, and operating the first neural stimulation generator to provide electrical stimulation to the nerves via the electrodes.