Topical Nerve Labeling Dyes for Image-Guided Surgery

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Solution Overview

Problem

Current surgical techniques face challenges in visualizing and preserving small nerves during procedures like cancer surgery due to their intricacy and proximity to surrounding tissues, leading to unintended nerve injuries and post-operative complications such as urinary and sexual dysfunction.

Innovation Solution

Development of topical nerve labeling agents that bind to myelin basic protein, allowing for intraoperative fluorescence-guided imaging by topical application, using a compound of Formula I or its salt in conjunction with an aqueous pharmaceutical carrier, enabling precise visualization of nerves through specific binding and reduced non-specific binding.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Measurement precision

If systemic administration of contrast agents is used for nerve visualization, then nerve identification capability is improved, but systemic absorption and toxicity risks increase

Engineering Contradiction:
Improvenerve identification capabilityVSAvoidsystemic absorption and toxicity
Core Design Contradiction:
Measurement precisionVSObject-affected harmful factors

Solution Approach 1:

The patent applies local quality by transitioning from systemic to topical administration of the contrast agent. The agent is applied directly to the surgical site where nerve visualization is needed, creating high local concentration at the target area while minimizing systemic distribution. This resolves the contradiction by improving nerve identification capability locally without exposing the entire body to the agent's toxic effects.

Inventive Principle:
Principle #3Local quality

Solution Approach 2:

The topical application formulation acts as an intermediary that delivers the contrast agent precisely to the surgical field. The formulation includes components that facilitate localized delivery and control, serving as a mediator between the contrast agent and the target tissue, thereby achieving effective nerve visualization while limiting systemic exposure.

Inventive Principle:
Principle #24Intermediary (Mediator)

2Object-affected harmful factors

If topical application of contrast agent is used, then safety profile is improved by limiting systemic absorption, but the timing and duration of nerve visualization control is required

Engineering Contradiction:
Improvesystemic absorptionVSAvoidtiming control requirement
Core Design Contradiction:
Object-affected harmful factorsVSEase of operation

Solution Approach 1:

The patent applies preliminary action by providing a pre-formulated topical solution that is ready for immediate application at the surgical site. The formulation is designed in advance with appropriate solvents and concentrations, allowing the surgeon to simply apply it topically without complex preparation. This resolves the contradiction by making the timing control straightforward while maintaining the safety benefits of localized delivery.

Inventive Principle:
Principle #10Preliminary action

3Quantity of substance

If topical administration is used to produce high dose at surgical site, then contrast agent concentration at target is improved, but application complexity increases

Engineering Contradiction:
Improvecontrast agent concentration at surgical siteVSAvoidapplication process complexity
Core Design Contradiction:
Quantity of substanceVSDevice complexity

Solution Approach 1:

The patent applies parameter changes by optimizing the formulation parameters of the topical solution, including solvent composition, pH, and concentration of the contrast agent. These parameters are adjusted to maximize penetration and binding at the surgical site while maintaining simple application characteristics. This resolves the contradiction by achieving high local concentration through formulation optimization rather than complex application procedures.

Inventive Principle:
Principle #35Parameter changes

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 topical agents provide high and sustained contrast at the surgical site, reducing the risk of nerve damage by allowing surgeons to accurately identify and avoid nerves, with improved safety and efficacy compared to systemic administration.

Implementation Method 1

topical agents capable of binding myelin-basic protein

Methodology Applied
Scientific EffectSpecific binding:

Implementation Method 2

detecting the agent by applying a light source tuned to the spectral excitation characteristics of the agent, and observing the subject through an optical filter tuned to the spectral emission characteristics of the agent

Methodology Applied
Scientific EffectFluorescence: Fluorescence

Data Source

PatentUS20230364269A1Topical application of nerve labeling DYES for image-guided surgery
Publication Date: 2023.11.16 PLYMOUTH TECHNOLOGIES LLC
  • US20230364269A1 patent drawing
  • US20230364269A1 patent drawing
  • US20230364269A1 patent drawing

AI summary

The present invention relates to a topical agent that binds specifically to myelin basic protein and its method of use and determining myelination in the subject by detecting the agent present in the subject. A kit containing the agent or its derivatives for use in detecting myelin basic protein is also provided.