Tissue Stimulation Adapter for Nerve Integrity Evaluation

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Solution Overview

Problem

Surgical procedures face challenges in accurately identifying and safeguarding against nerve and muscle injuries due to variations in human anatomy, and existing methods are inadequate for determining muscle and nerve integrity, especially during traumatic injuries and reconstructive surgeries.

Innovation Solution

A tissue stimulation system with a housing and an operative element for electrical stimulation, coupled with a stimulation control device that generates signals of varying amplitude and duration, providing visual and audio feedback to assist surgeons in identifying and assessing nerve and muscle integrity during surgeries.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Measurement precision

If visual inspection is used to determine nerve and muscle integrity, then the procedure is simple and quick, but the accuracy and reliability of evaluation is insufficient

Engineering Contradiction:
Improvenerve and muscle integrity evaluation accuracyVSAvoidevaluation system complexity
Core Design Contradiction:
Measurement precisionVSDevice complexity

Solution Approach 1:

The patent replaces visual inspection (mechanical/sensory system) with electrical stimulation and electronic detection systems. The stimulator delivers controlled electrical pulses to nerves and muscles, and sensors detect the physiological responses, providing objective quantitative data that supersedes subjective visual assessment.

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

Solution Approach 2:

The patent introduces electrical stimulation as an intermediary between the surgeon and the neuromuscular system. Instead of directly observing nerve and muscle integrity, the system uses electrical signals as a mediator to elicit and detect physiological responses, enabling indirect but more accurate assessment of tissue integrity.

Inventive Principle:
Principle #24Intermediary (Mediator)

2Measurement precision

If electrical stimulation is applied to identify targeted nerves and muscles, then the precision of identification improves, but the risk of causing unintended muscle contraction or nerve damage increases

Engineering Contradiction:
Improvenerve and muscle identification accuracyVSAvoidunintended muscle contraction or nerve injury
Core Design Contradiction:
Measurement precisionVSObject-affected harmful factors

Solution Approach 1:

The patent employs dynamic adjustment of stimulation parameters (amplitude, pulse duration, frequency) based on real-time physiological feedback. The system continuously monitors responses and adapts stimulation levels to maximize identification accuracy while staying below thresholds that would cause harmful effects.

Inventive Principle:
Principle #15Dynamics

Solution Approach 2:

The patent implements a closed-loop feedback system where the physiological response to stimulation is detected and used to adjust subsequent stimulation parameters. This feedback mechanism allows the system to identify nerves and muscles accurately while automatically preventing stimulation levels that would cause unintended muscle contraction or nerve damage.

Inventive Principle:
Principle #23Feedback

Solution Approach 3:

The patent utilizes controlled changes in electrical stimulation parameters (voltage, current, pulse width, frequency) to differentiate between various nerves and muscles. By systematically varying these parameters and observing differential responses, the system achieves precise identification without applying consistently high stimulation levels that could cause harm.

Inventive Principle:
Principle #35Parameter changes

3Adaptability or versatility

If a standardized stimulation device is used across different surgical procedures, then device complexity is reduced, but adaptability to different anatomical variations and surgical needs is limited

Engineering Contradiction:
Improveadaptability to anatomical variations and surgical proceduresVSAvoiddevice configuration and operation complexity
Core Design Contradiction:
Adaptability or versatilityVSDevice complexity

Solution Approach 1:

The patent designs a universal stimulation system that can perform multiple functions: identifying nerves, identifying muscles, assessing integrity, and guiding surgical procedures. The device incorporates adjustable parameters and interchangeable components that allow a single platform to adapt to different anatomical regions and surgical requirements without requiring multiple specialized devices.

Inventive Principle:
Principle #6Universality (Multi-functionality)

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 enables accurate evaluation of the neuromuscular system, guiding repair or reconstructive surgery by providing reliable indications of nerve and muscle function, reducing the risk of injury and improving surgical outcomes.

Implementation Method 1

an operative element having an electrically conductive surface sized and configured for electrical stimulation of a targeted tissue region

Methodology Applied
Scientific EffectElectrical stimulation: Electric Field

Implementation Method 2

The first indication comprises a visual indication located on the housing... providing a first indication

Methodology Applied
Scientific EffectElectromechanical transduction: Electromechanical Film

Data Source

PatentUS11576599B2Stimulation device adapter
Publication Date: 2023.02.14 CHECKPOINT SURGICAL LLC
  • US11576599B2 patent drawing
  • US11576599B2 patent drawing
  • US11576599B2 patent drawing

AI summary

A stimulation device includes an adapter component to increase the usability of the stimulation device. The adapter may be a bipolar adapter arranged to connect to the housing of the stimulation device. The adapter may include a clip having a first channel configured to receive an operative element therein and a second channel having a return operative element therein. The return operative element is in electrical communication with an electrical circuit of said stimulation control device. Alternatively, the adapter may be a percutaneous adapter comprising a connector configured to connect to an operative element of a stimulation device and a lead wire connected to the connector. A needle may be connected to the lead wire to deliver a electrical stimulation signal to a target tissue located beneath the skin of a subject patient.