Head-Mounted RF Neurostimulator for Chronic Head Pain

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Solution Overview

Problem

Conventional implantable neurostimulation systems designed for spinal cord stimulation are inadequate for treating chronic head pain due to anatomical and physiological differences between the head and spinal canal, leading to inadequate therapeutic responses, patient comfort issues, and increased medical risks.

Innovation Solution

A fully head-located, radiofrequency-coupled, unibody peripheral nerve stimulation system with extended leads and multiple surface electrode arrays is designed for simultaneous neurostimulation of the frontal, parietal, and occipital regions, featuring a smaller diameter and optimized electrode placement to improve therapeutic coverage and reduce surgical risks.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If conventional implantable neurostimulation systems designed for spinal cord stimulation are used, then the system structure is simple and well-established, but the therapeutic response is inadequate and medical risks increase due to anatomical differences between the head and spinal canal

Engineering Contradiction:
Improvetherapeutic responseVSAvoidsystem structure
Core Design Contradiction:
ReliabilityVSDevice complexity

Solution Approach 1:

The system divides the head into multiple treatment zones (frontal, parietal, occipital regions) with separate electrode arrays positioned in each region. This segmentation allows targeted neurostimulation of specific head areas, improving therapeutic response for chronic head pain while maintaining a manageable system structure through modular electrode placement.

Inventive Principle:
Principle #1Segmentation

Solution Approach 2:

The patent transitions from the conventional single-lead spinal cord stimulation approach to a multi-dimensional head-mounted system with electrodes distributed across multiple surfaces and regions of the head. This spatial dimensionality change enables comprehensive coverage of head pain areas while adapting the system architecture to cranial anatomy rather than spinal anatomy.

Inventive Principle:
Principle #17Another dimension (Dimensionality change)

2Ease of operation

If conventional neurostimulation leads are used, then the lead design is simple and standardized, but patient comfort deteriorates and cosmetic outcomes worsen due to inadequate sizing for head anatomy

Engineering Contradiction:
Improvepatient comfortVSAvoidlead design
Core Design Contradiction:
Ease of operationVSDevice complexity

Solution Approach 1:

The system employs different lead configurations and electrode designs tailored to specific head regions. Leads are sized and shaped appropriately for cranial implantation rather than spinal dimensions, with electrode arrays optimized for contact with head nerves in frontal, parietal, and occipital areas. This local optimization improves patient comfort and cosmetic outcomes while managing design complexity through region-specific customization.

Inventive Principle:
Principle #3Local quality

3Reliability

If multiple separate surgical procedures are performed to achieve adequate therapeutic coverage, then comprehensive neurostimulation is achieved, but surgical risks increase and patient burden increases

Engineering Contradiction:
Improvetherapeutic coverageVSAvoidsurgical risks
Core Design Contradiction:
ReliabilityVSObject-affected harmful factors

Solution Approach 1:

The system combines multiple electrode arrays and stimulation functions into a single integrated implantable system. Multiple electrode arrays are positioned simultaneously during one surgical procedure to cover frontal, parietal, and occipital regions, consolidating what would traditionally require multiple separate surgeries into a single procedure. This merging reduces surgical risks and patient burden while maintaining comprehensive therapeutic coverage.

Inventive Principle:
Principle #5Merging (Combining)

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 system provides effective, simultaneous neurostimulation across multiple head regions, reducing the need for multiple surgical procedures, minimizing surgical risks, and enhancing patient comfort and cosmetic outcomes.

Implementation Method 1

The IPG may have a component, or extension, containing an internal radiofrequency receiver, the purpose of which is to couple to an external power source and control unit

Methodology Applied
Scientific EffectRadiofrequency coupling: Electromagnetic Induction

Data Source

PatentUS9498635B2Implantable head located radiofrequency coupled neurostimulation system for head pain
Publication Date: 2016.11.22 SHIRATRONICS INC
  • US9498635B2 patent drawing
  • US9498635B2 patent drawing
  • US9498635B2 patent drawing

AI summary

An implantable head-mounted, radiofrequency (RF) coupled, unibody peripheral neurostimulation system is provided for implantation in the head for the purpose of treating chronic head pain, including migraine. The system may include an implantable pulse generator (IPG) from which multiple stimulating leads may extend sufficient to allow for adequate stimulation over multiple regions of the head, preferably including the frontal, parietal and occipital regions. A lead may include an extended body, along which may be disposed a plurality of surface metal electrodes (SME), which may be subdivided into a plurality of electrode arrays. A plurality of internal metal wires may run a portion of its length and connect the IPG's internal circuit to the SME. The IPG may include an RF receiver coil and an application specific integrated circuit. The IPG may be capable of functional connection to an external RF unit for purposes that may include power, diagnostics, and programming.