Double-Barrel Delivery Tool for Reversible Sphenopalatine Stimulation
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Solution Overview
Problem
Current treatments for headaches, particularly those targeting the sphenopalatine ganglion, are either too invasive or non-reversible, lacking a less invasive and reversible option that effectively modulates neuronal activity to alleviate headache symptoms.
Innovation Solution
A surgical tool and method for delivering a neurostimulator with integral stimulation leads to the pterygopalatine fossa, utilizing a handle, elongated shaft, hub portion, and double barrel sheath to position electrodes in close proximity to the sphenopalatine ganglion, allowing for targeted electrical modulation.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If surgical ganglionectomy or ablation procedures are performed to modulate SPG function, then headache treatment efficacy is improved, but invasiveness increases and reversibility is lost
Solution Approach 1:
The patent introduces a neurostimulator as an intermediary device that delivers electrical stimulation to the SPG through a delivery tool, avoiding direct surgical intervention on the ganglion itself. This mediator approach provides reversible modulation while maintaining treatment efficacy, resolving the contradiction between effectiveness and invasiveness
Solution Approach 2:
The patent replaces mechanical surgical procedures (ganglionectomy, ablation) with electrical stimulation therapy. The neurostimulator uses electrical fields to modulate SPG function rather than physical destruction or removal, reducing invasiveness while maintaining therapeutic benefit
2Ease of operation
If trans-coronoid notch approach is used to access SPG, then direct access to ganglion is achieved, but tissue dissection and procedural complexity increase
Solution Approach 1:
The delivery tool acts as an intermediary that navigates through existing anatomical pathways to reach the SPG without requiring direct surgical exposure. This mediator approach simplifies the procedure by avoiding complex tissue dissection while maintaining direct access to the target ganglion
3Manufacturing precision
If integral stimulation leads are used with neurostimulator, then lead placement precision is improved, but device complexity increases
Solution Approach 1:
The patent merges the neurostimulator body with integral stimulation leads into a single unified device. This combination eliminates the need for separate lead implantation procedures and reduces overall device complexity while maintaining precise lead placement at the SPG target site
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 less invasive, reversible, and effective electrical stimulation of the sphenopalatine ganglion to treat headaches, providing relief with reduced tissue dissection and procedural complexity.
Implementation Method 1
The neurostimulator can include a body connected to an integral stimulation lead having one or more stimulating electrodes... enabling less invasive, reversible, and effective electrical stimulation of the sphenopalatine ganglion
Data Source
AI summary
One aspect of the present disclosure includes a delivery tool configured to deliver a neurostimulator into a pterygopalatine fossa of a subject. The neurostimulator can include a body connected to an integral stimulation lead having one or more stimulating electrodes. The delivery tool can comprise a handle, an elongated shaft extending from the handle, a hub portion, and a double barrel sheath. The hub portion can be located between the shaft and a spine member that extends axially away from the hub portion. The hub portion can be sized and dimensioned to releasably mate with the neurostimulator. The double barrel sheath can be connected to the spine member. A central lumen can extend through at least a portion of the shaft and the hub portion. The central lumen can be adapted to receive a lead ejector for selective deployment of the stimulation lead from the double barrel sheath.