Neural Stimulator Delivery via Impedance Navigation

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Solution Overview

Problem

Current medical procedures for implanting neural stimulators at the sphenopalatine ganglion lack precision and require skilled surgeons, as they involve navigating complex anatomical structures like the greater palatine canal, which can be challenging even with existing surgical guides.

Innovation Solution

A system comprising an implantable neural stimulator, a steerable delivery guide, and an oral surgical guide generated from CT and intra-oral scans, allowing for minimally invasive procedures with precise guidance through a guide hole in the surgical guide that aligns with the greater palatine foramen, facilitated by shape-sensing optical fibers and impedance-based navigation.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Measurement precision

If traditional surgical methods are used for implanting neural stimulators, then the procedure can be performed with existing tools, but the precision of implant placement is insufficient and requires highly skilled surgeons

Engineering Contradiction:
Improveprecision of implant placementVSAvoidcomplexity of surgical guidance system
Core Design Contradiction:
Measurement precisionVSDevice complexity

Solution Approach 1:

The surgical guide is fabricated before surgery based on pre-operative CT scans and intra-oral impressions. The guide incorporates a guide hole pre-positioned to align with the greater palatine foramen, eliminating the need for complex intraoperative navigation and enabling precise implant placement even by less-skilled surgeons

Inventive Principle:
Principle #10Preliminary action

Solution Approach 2:

The surgical guide acts as an intermediary device between the pre-operative planning and the actual implantation procedure. It translates complex 3D anatomical data into a simple physical guide with a pre-calculated access path, mediating between the surgeon's actions and the precise anatomical target

Inventive Principle:
Principle #24Intermediary (Mediator)

2Object-affected harmful factors

If a minimally invasive procedure is used to access the greater palatine canal, then patient trauma is reduced, but navigating the complex anatomical structure becomes more challenging

Engineering Contradiction:
Improvepatient traumaVSAvoidease of navigating greater palatine canal
Core Design Contradiction:
Object-affected harmful factorsVSEase of operation

Solution Approach 1:

The optimal puncture site and angle are determined in advance through pre-operative imaging and incorporated into the surgical guide design. The guide hole is pre-formed at the correct location and orientation, allowing the practitioner to simply follow the pre-planned path without needing to navigate complex anatomy during the procedure

Inventive Principle:
Principle #10Preliminary action

Solution Approach 2:

The surgical process is divided into distinct segments: pre-operative scanning and planning, fabrication of the custom surgical guide, and the simplified intraoperative procedure. This segmentation moves the complexity from the surgical act itself to the preparatory phase, making the actual implantation easier and more precise

Inventive Principle:
Principle #1Segmentation

Data Source

PatentEP3329962B1Implant and delivery system for neural stimulator
Publication Date: 2020.05.13 BRAINSGATE LTD
  • EP3329962B1 patent drawingFigure 1
  • EP3329962B1 patent drawingFigure 2
  • EP3329962B1 patent drawingFigure 3A~3B

AI summary

Apparatus is provided including an implantable neural stimulator which is advanced through a greater palatine canal to a sphenopalatine ganglion (SPG) of a subject and has an implant-impedance-sensing electrode. The apparatus further includes an auxiliary-impedance-sensing electrode and first and second wires, electrically coupled respectively to the implant-impedance-sensing and auxiliary-impedance-sensing electrodes. Impedance-based navigation circuitry includes a voltage generator configured to apply current between the implant-impedance-sensing and auxiliary-impedance-sensing electrodes through the wires; an impedance sensor configured to measure an impedance between the implant-impedance-sensing and auxiliary-impedance-sensing electrodes based on the applying of the current; and a disposition tracker configured to determine, based on a change in the measured impedance, a disposition of the implantable neural stimulator in the greater palatine canal. Other applications are also described.