Nerve Stimulation Navigation System for Obstructive Sleep Apnea

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Solution Overview

Problem

Current surgical navigation techniques lack the ability to accurately and efficiently visualize soft and hard tissues simultaneously with muscle activation responses during the placement of stimulation elements, such as electrodes, which is crucial for procedures like treating obstructive sleep apnea, due to the complexity of internal anatomical structures and the need for precise nerve and muscle stimulation.

Innovation Solution

A system that integrates image-based navigation with neuromuscular response evaluation, using a graphical user interface to display internal anatomical structures and muscle activation in real-time, allowing for precise placement of stimulation elements by differentiating between target and non-target muscles through color, shading, and patterns, and providing quantitative evaluation of muscle responses.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Loss of information

If traditional radiographic techniques (such as X-ray) are used for imaging, then bony structures can be visualized, but soft tissues and internal organs remain unidentifiable

Engineering Contradiction:
Improvevisibility of soft tissuesVSAvoidimaging technique complexity
Core Design Contradiction:
Loss of informationVSDevice complexity

Solution Approach 1:

The patent combines multiple imaging modalities (MRI for soft tissue visualization, CT for bony structure imaging, and ultrasound for real-time guidance) into a single integrated surgical navigation system. This merging allows simultaneous acquisition and display of multiple tissue types without requiring separate procedures, resolving the contradiction between comprehensive tissue visibility and imaging complexity.

Inventive Principle:
Principle #5Merging (Combining)

Solution Approach 2:

The patent introduces an image processing system as an intermediary that automatically processes, registers, and integrates images from different modalities. This intermediary layer simplifies the complexity of multi-modality imaging by providing automated alignment and visualization tools, making the complex imaging process manageable while achieving comprehensive tissue visualization.

Inventive Principle:
Principle #24Intermediary (Mediator)

2Measurement precision

If surgical navigation without real-time muscle activation feedback is used, then the surgical process is simpler, but precise placement of stimulation elements cannot be ensured

Engineering Contradiction:
Improveplacement accuracyVSAvoidnavigation system complexity
Core Design Contradiction:
Measurement precisionVSDevice complexity

Solution Approach 1:

The patent implements real-time feedback by displaying muscle activation responses (EMG signals) during the surgical procedure. The system shows which muscles are activated when electrical stimulation is applied at different locations, allowing the surgeon to immediately adjust the stimulation element placement to achieve the desired muscle activation, thereby ensuring precise placement accuracy.

Inventive Principle:
Principle #23Feedback

Solution Approach 2:

The patent performs preliminary mapping of the anatomical region using preoperative MRI and CT images to identify the locations of nerves and muscles before the actual stimulation placement. This preliminary action creates a navigation framework that guides the surgical procedure, reducing the complexity of real-time decision-making while ensuring accurate placement.

Inventive Principle:
Principle #10Preliminary action

3Ease of operation

If simultaneous visualization of anatomical structures and muscle activation is not provided, then the surgical process is less complex, but the ability to differentiate between target and non-target muscles is compromised

Engineering Contradiction:
Improvesurgical procedure simplicityVSAvoidmuscle differentiation information
Core Design Contradiction:
Ease of operationVSLoss of information

Solution Approach 1:

The patent segments the display interface into separate panels: one showing anatomical structures (from MRI/CT) and another showing real-time muscle activation (from EMG). This segmentation allows the surgical system to maintain relative simplicity in each component while providing comprehensive information integration, making it easier to operate without losing muscle differentiation information.

Inventive Principle:
Principle #1Segmentation

Solution Approach 2:

The patent uses color-coded displays to differentiate between target and non-target muscles. The EMG display shows activated muscles in one color and non-target muscles in another color, providing immediate visual feedback that simplifies the surgical decision-making process while maintaining complete muscle differentiation information.

Inventive Principle:
Principle #32Color changes

4Reliability

If quantitative evaluation of muscle responses is not performed, then the system is less complex, but treatment efficacy cannot be optimized

Engineering Contradiction:
Improvetreatment efficacyVSAvoidevaluation system complexity
Core Design Contradiction:
ReliabilityVSDevice complexity

Solution Approach 1:

The patent replaces manual assessment of muscle responses with automated quantitative analysis of EMG signals. The system automatically measures parameters such as muscle activation amplitude, timing, and duration, providing objective data that optimizes treatment efficacy without requiring complex manual evaluation procedures.

Inventive Principle:
Principle #28Mechanics substitution (Replace mechanical system)

Data Source

PatentUS12053289B2Method and system for identifying a location for nerve stimulation
Publication Date: 2024.08.06 INSPIRE MEDICAL SYSTEMS INC
  • US12053289B2 patent drawing
  • US12053289B2 patent drawing
  • US12053289B2 patent drawing

AI summary

A system and method for identifying a stimulation location on a nerve is disclosed. The system includes an image-based navigation interface used to facilitate advancing a stimulation element within a patient body toward a target nerve stimulation site. Using the system one determines, separately for each potential target nerve stimulation site, a neuromuscular response of muscles produced upon applying a stimulation signal at the respective separate potential target stimulation sites. The image-based navigation interface is configured to display a graphic identification of which muscles were activated for each respective potential target nerve stimulation site upon applying the stimulation signal.