Flexible Circuit Leads for Targeted Spinal Nerve Stimulation
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Solution Overview
Problem
Conventional spinal cord stimulation systems face challenges in precision and specificity, often stimulating both sensory and motor nerve tissues indiscriminately, leading to undesirable side effects and difficulty in controlling stimulation energy due to variations in tissue and fluid conditions along the spine.
Innovation Solution
The development of flexible circuit implantable leads with biocompatible materials and designs that allow for precise placement near specific nerve anatomies, such as the dorsal root and dorsal root ganglion, enabling targeted stimulation with reduced energy requirements and minimized side effects.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If conventional paddle leads or percutaneous leads are used for spinal cord stimulation, then the lead can be implanted and provide stimulation coverage, but the stimulation energy is applied indiscriminately to both sensory and motor nerve tissues, causing undesirable side effects
Solution Approach 1:
The lead is segmented into multiple discrete electrodes (e.g., 4-8 electrodes) arranged in a linear array, allowing selective activation of specific electrodes to target specific nerve structures. This segmentation enables precise control over which nerve tissues receive stimulation, separating sensory nerve targeting from motor nerve activation.
Solution Approach 2:
The lead design provides different functional zones along its length, with electrodes positioned to create localized stimulation fields. By adjusting which electrodes are activated and their respective current intensities, the system creates locally optimized stimulation patterns that selectively engage sensory nerves while avoiding motor nerves in different spinal segments.
2Reliability
If conventional leads stimulate a wide portion of the spinal cord to ensure coverage, then pain relief may be achieved, but the energy requirements increase and battery life decreases
Solution Approach 1:
The system extracts and activates only the specific electrodes and neural pathways necessary for pain relief, rather than stimulating the entire spinal cord. By identifying and targeting only the relevant sensory nerve fibers and spinal segments involved in pain transmission, the system reduces overall energy consumption while maintaining therapeutic effectiveness.
Solution Approach 2:
The system applies partial stimulation by activating only a subset of available electrodes with appropriate current intensities. This partial action approach provides sufficient stimulation to achieve pain relief through selective nerve fiber activation without the excessive energy expenditure required for broad, non-specific spinal cord stimulation.
3Ease of manufacture
If conventional leads are used with variations in tissue and fluid conditions along the spine, then implantation is straightforward, but controlling stimulation energy becomes difficult
Solution Approach 1:
The system employs dynamic control of stimulation parameters, allowing real-time adjustment of current intensity, pulse width, and electrode selection based on individual patient anatomy and response. This dynamic adaptability compensates for variations in tissue and fluid conditions along the spine, enabling precise energy control despite anatomical differences between patients and locations.
Solution Approach 2:
The system changes multiple stimulation parameters (current amplitude, pulse duration, frequency, and electrode configuration) to optimize delivery of therapeutic energy. By adjusting these parameters based on measured tissue impedance and patient feedback, the system achieves precise control over stimulation energy despite variations in spinal tissue and cerebrospinal fluid conditions.
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
The flexible circuit leads provide more precise and effective delivery of stimulation energy, reducing unwanted stimulation of non-target tissues, improving pain relief while minimizing the risk of tissue damage and extending battery life by using lower power requirements.
Implementation Method 1
application of an electrical field to spinal nervous tissue can effectively mask certain types of pain transmitted from regions of the body associated with the stimulated nervous tissue
Data Source
AI summary
Devices, systems and methods are provided for stimulation of tissues and structures within a body of a patient. In particular, implantable leads are provided which are comprised of a flexible circuit. Typically, the flexible circuit includes an array of conductors bonded to a thin dielectric film. Example dielectric films include polyimide, polyvinylidene fluoride (PVDF) or other biocompatible materials to name a few. Such leads are particularly suitable for stimulation of the spinal anatomy, more particularly suitable for stimulation of specific nerve anatomies, such as the dorsal root (optionally including the dorsal root ganglion).