Head-located Neurostimulator with Integral Leads
Solution Overview
Problem
Conventional implantable neurostimulation systems for treating chronic head pain face challenges due to their design, which was originally intended for spinal cord stimulation, leading to inadequate therapeutic response, patient safety and comfort issues, increased surgical risks, and technical problems such as lead migration and fracture, caused by the need for leads to cross multiple anatomic motion segments and the large size of the implantable pulse generator.
Innovation Solution
A low-profile, fully head-located unibody peripheral nerve stimulation system with an implantable pulse generator and neurostimulating leads that are configured to provide therapeutic neurostimulation unilaterally over the frontal, parietal, and occipital regions of the head, featuring a rechargeable battery, antenna coil, and ASIC, with a design that eliminates the need for external leads and reduces the number of surgical incisions and complications.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Ease of manufacture
If the IPG is implanted at a considerable anatomic distance from the cranial leads (in the lower back, lower abdomen, or gluteal region), then the device can be placed in a standard location for spinal cord stimulation, but the leads must cross multiple anatomic motion segments (neck and back), producing adverse tension and torque forces that increase the risk of lead migration and lead fracture
Solution Approach 1:
The patent merges the IPG location with the cranial implant site by positioning the IPG in the head region adjacent to the cranial leads, eliminating the need for long trans-body lead traverses and avoiding tension and torque forces across motion segments
Solution Approach 2:
The patent extracts the IPG from the standard spinal cord stimulation location (lower back/abdomen/gluteal region) and relocates it to the head region, removing it from the path of lead traversal and eliminating the mechanical stressors on the leads
2Use of energy by moving object
If the IPG is made relatively large to accommodate all electronics, then the device can contain sufficient battery capacity and circuitry, but it contributes to local discomfort, cosmetic concerns, and increases the size of the implantation pocket, which exacerbates infection risks
Solution Approach 1:
The patent segments the electronics into multiple smaller components distributed within the head region, with the IPG containing only essential circuitry and the battery placed separately, reducing the size of each individual implant and the overall infection risk
Solution Approach 2:
The patent transitions from a single large IPG to a distributed arrangement of smaller electronic components across the head region, utilizing spatial distribution to reduce the volume of each implant while maintaining total functionality
3Ease of operation
If multiple additional incisions are made to pass the leads from the IPG to their terminal positions in the head, then the leads can be routed to their destinations, but this increases the added risks of infection, wound dehiscence, discomfort, and cosmetic problems
Solution Approach 1:
The patent merges the IPG implantation site with the cranial lead terminal position, allowing leads to be routed directly from the IPG to the target cranial nerves through a single implantation site, eliminating the need for multiple additional incisions and reducing surgical complications
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 system provides effective, comfortable, and cosmetically acceptable therapeutic neurostimulation for chronic head pain across multiple regions simultaneously, reducing surgical risks and complications by integrating all electronics near the skull and minimizing the need for external leads and anchors.
Implementation Method 1
a coil positioned adjacent the first end of the metal can, the coil operable to charge the battery
Data Source
Figure 1~2
Figure 3
Figure 3A~3B
AI summary
A method for subcutaneously treating pain in a patient includes first providing a neurostimulator with an IPG body and at least a primary, a secondary, and a tertiary integral lead with electrodes disposed thereon. A primary incision is opened to expose the subcutaneous region below the dermis in a selected portion of the body. A pocket is then opened for the IPG through the primary incision and the integral leads are inserted through the primary incision and routed subcutaneously to desired nerve regions along desired paths. The IPG is disposed in the pocket through the primary incision. The primary incision is then closed and the IPG and the electrodes activated to provide localized stimulation to the desired nerve regions and at least three of the nerves associated therewith to achieve a desired pain reduction response from the patient.