Transnasal SPG Stimulation Device for Cluster Headache Treatment
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Solution Overview
Problem
Current methods for treating severe headaches, such as cluster headaches, using electrical stimulation of the sphenopalatine ganglion (SPG) are limited by the difficulty of accessing the SPG due to its complex and variable anatomy, and existing electrical stimulators are not suitable for transnasal placement, leading to potential damage to blood vessels and nerves.
Innovation Solution
A transnasal electrical stimulation device that uses electrodes and a pulse generator to deliver electrical impulses to the SPG, allowing for noninvasive or minimally invasive placement without breaching the pterygopalatine fossa, using wireless energy transmission and a dipole antenna to power the stimulator, which can be secured to the nasopharyngeal mucosa or underlying tissue.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If existing electrical stimulators are used to treat SPG, then electrical stimulation of SPG can be achieved, but the complex and variable anatomy of SPG makes access difficult and may cause damage to blood vessels and nerves
Solution Approach 1:
The device segments the stimulation function into multiple electrode contacts (first electrode contact, second electrode contact, third electrode contact) arranged in a specific geometric pattern, allowing selective stimulation of different neural targets while avoiding surrounding structures. This segmentation enables precise control over which nerve fibers are stimulated, improving safety by avoiding damage to blood vessels and nerves outside the target area.
Solution Approach 2:
The patent introduces a novel electrode geometry and configuration as an intermediary between the external stimulator and the SPG. The specific arrangement of electrode contacts creates a controlled electric field pattern that acts as a mediator to selectively engage the SPG while sparing surrounding sensitive structures, thus resolving the contradiction between accessibility and safety.
2Productivity
If invasive methods are used to access SPG, then electrical stimulation can be delivered, but potential damage to surrounding tissues occurs
Solution Approach 1:
The electrode contacts are designed with specific local geometric arrangements where each contact has a defined orientation and spacing. This local quality control ensures that the electric field is concentrated precisely at the SPG location while maintaining low intensity in surrounding tissues, thereby achieving effective treatment without causing damage to adjacent blood vessels and nerves.
Solution Approach 2:
The patent employs adjustable electrical stimulation parameters including pulse width, amplitude, and frequency that can be modified to optimize therapeutic effect while minimizing tissue damage. The geometric parameters of the electrode contacts (spacing, orientation, size) are also designed to control the spatial distribution of the electric field, creating a safety margin that prevents harmful effects to surrounding tissues.
3Reliability
If traditional electrical stimulator placement is used, then SPG stimulation is possible, but the procedure is complex and requires breaching the pterygopalatine fossa
Solution Approach 1:
The electrode array design provides multi-functionality by enabling stimulation of the SPG through a standardized geometric configuration that can be delivered via a single access route. The universal geometric pattern of electrode contacts allows the device to achieve accurate nerve targeting without requiring complex custom positioning or breaching of the pterygopalatine fossa, thereby simplifying the placement procedure while maintaining reliability.
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
Enables effective and reversible inhibition of SPG activity without damaging surrounding tissues, providing a safer and more efficient treatment for conditions like cluster headaches, with the potential for quicker recovery and reduced scarring.
Implementation Method 1
using wireless energy transmission and a dipole antenna to power the stimulator
Implementation Method 2
A transnasal electrical stimulation device that uses electrodes and a pulse generator to deliver electrical impulses to the SPG
Data Source
AI summary
Devices, systems and methods are disclosed for modulating cranial nerves, such as the sphenopalatine ganglion, to treat a medical condition of a patient, such as cluster headache. A stimulation device is advanced transnasally to a target site at or adjacent to the nasopharyngeal mucosa posterior to the middle turbinate. Electrical impulses are applied through one or more electrodes in the stimulation device to the target nerve sufficient to modulate the nerve and treat the medical condition.