Anchored Neuromodulation Lead for Stable Spinal Stimulation
Find Innovative SolutionsGenerate Solutions
Solution Overview
Problem
Current neuromodulation techniques for pain management, such as spinal cord stimulation, face challenges including low efficacy, complications from lead migration, and invasive procedures, with approximately 20-40% of patients requiring lead revision or explantation due to undesirable positioning and scarring.
Innovation Solution
The development of minimally invasive devices and systems that utilize leads with improved anchoring mechanisms to reduce migration while allowing for easy repositioning or removal, targeting specific anatomies like the dorsal root ganglion with multiple electrode groupings spaced along the lead to treat multiple areas simultaneously, thereby reducing complications and procedure time.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If conventional spinal cord stimulation leads are used, then pain relief can be achieved, but lead migration and scarring cause loss of stimulation and require revision or explantation in 20-40% of patients
Solution Approach 1:
The lead is divided into multiple segments or sections, each with specific anchoring features at different locations. The anchoring features are distributed along the lead body rather than concentrated at a single point, allowing progressive engagement with surrounding tissues to prevent migration while maintaining stimulation effectiveness.
Solution Approach 2:
Anchoring features are pre-formed or pre-positioned on the lead before implantation. These features are designed to engage with surrounding tissues immediately upon deployment, preventing lead migration before scarring can occur. The anchoring action is performed preliminarily during the implantation procedure itself.
2Stability of the object's composition
If leads are firmly anchored to prevent migration, then lead position stability improves, but the ability to reposition or remove leads without damaging nerve tissue is reduced
Solution Approach 1:
The anchoring system transitions from a static, permanent fixation to a dynamic, reversible engagement. The anchoring features can be actively engaged during implantation to prevent migration, then actively disengaged or released when repositioning or removal is needed. This dynamic capability allows the system to adapt between stability and flexibility based on clinical needs.
Solution Approach 2:
The anchoring mechanism is designed to be temporarily active during the implantation and initial healing period to prevent migration, then can be discarded or released when no longer needed. The anchoring features may be designed to degrade, detach, or be actively released, allowing lead removal without permanent attachment to nerve tissue.
3Adaptability or versatility
If multiple separate leads are used to treat multiple target areas, then comprehensive pain management is achieved, but surgical complexity and procedure time increase
Solution Approach 1:
Multiple leads are merged into a single integrated lead structure that can deliver stimulation to multiple target areas simultaneously. The lead incorporates multiple electrode arrays or stimulation zones that can be independently controlled, allowing comprehensive pain management across multiple dermatomes or spinal levels through a single implantation procedure.
Solution Approach 2:
The lead is designed with universal applicability to treat multiple different pain syndromes and target multiple anatomical regions. The lead incorporates adjustable stimulation parameters, multiple electrode configurations, and flexible positioning capabilities that allow it to function effectively for various clinical indications without requiring separate specialized leads.
4Adaptability or versatility
If multiple needle sticks are used to access different target areas, then complete coverage of pain pathways is achieved, but patient discomfort and risk of cerebral spinal fluid leaks increase
Solution Approach 1:
Multiple access points and needle sticks are merged into a single access route. The lead design allows it to be delivered through one epidural space entry point and then navigated to multiple target areas using internal steering mechanisms, curved trajectories, or flexible segments, thereby eliminating the need for multiple separate needle punctures through the dura and epidural space.
Applied Scientific Principles
This section explains which scientific principles are used to turn an abstract innovation direction into a practical engineering solution.
Function Achieved in This Case
This approach enhances pain management by minimizing side effects, reducing complications, and allowing for more precise and stable stimulation of targeted anatomies, with the potential for fewer needle sticks and shorter recovery times, while maintaining the ability to easily reposition or remove the leads.
Implementation Method 1
Electrical stimulation involves the application of electrodes to the brain, the spinal cord or peripheral nerves of a patient. These precisely placed electrodes are typically mounted on a lead that is connected to a pulse generator and power source, which generates the necessary electrical stimulation.
Implementation Method 2
In the case of pharmacological agents delivered through implanted leads or catheters, the drug can be administered in smaller doses because it does not have to be metabolized and pass through the body before reaching the target area.
Data Source
Figure 1A
Figure 1B~1E
Figure 2A
AI summary
Devices, systems and methods for treating pain or other conditions while minimizing possible complications and side effects. Treatment typically includes electrical stimulation and/or delivery of pharmacological or other agents with the use of a lead or catheter. The devices, systems and methods provide improved anchoring which reduces migration of the lead yet allows for easy repositioning or removal of the lead if desired. The devices, systems and methods also provide for simultaneous treatment of multiple targeted anatomies. This shortens procedure time and allows for less access points, such as needle sticks to the epidural space, which in turn reduces complications, such as cerebral spinal fluid leaks, patient soreness and recovery time. Other possible complications related to the placement of multiple devices are also reduced.