Gamma-Sterilizable Surgical Ink Composition for Wet Tissue Marking
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Solution Overview
Problem
Existing surgical inks using crystal violet as a main component pose safety concerns and lack biocompatibility, and existing pigment inks do not guarantee sterility after gamma-ray irradiation, affecting writing properties and convenience.
Innovation Solution
A surgical ink containing activated carbon powder, polyvinylpyrrolidone, and propylene glycol, with a pH of 4 to 11 and viscosity of 2.0 to 8.0 mPa·s, and a surgical pen with a synthetic resin pen tip, designed for stable ink discharge and biocompatibility, are developed to ensure safety and writing convenience.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Illumination intensity
If crystal violet dye ink is used for surgical marking, then the ink provides good coloration and visibility, but it exhibits carcinogenicity and lacks biocompatibility
Solution Approach 1:
The patent changes the chemical composition parameters of the ink by replacing crystal violet with carbon black pigment and adjusting the solvent system to include water-soluble organic solvents, thereby eliminating carcinogenicity while maintaining visibility through alternative coloration mechanisms
Solution Approach 2:
The patent creates a composite ink formulation combining carbon black pigment with water-soluble organic solvents and optional resin materials, achieving both safety (biocompatibility) and functionality (visibility) through the synergistic combination of multiple components
2Ease of operation
If water-soluble dye ink is used for surgical marking, then the ink is easy to apply, but it immediately diffuses and smears in tissue fluid causing inaccurate marking
Solution Approach 1:
The patent formulates a composite ink system combining carbon black pigment with water-soluble organic solvents and resin materials, where the resin component provides binding capability that prevents smearing while the water-soluble organic solvent ensures easy application, thus resolving the contradiction between ease of application and marking accuracy
Solution Approach 2:
The patent creates different functional components within the ink with distinct properties: the carbon black pigment provides coloration, the water-soluble organic solvent provides ease of application, and the resin material provides smear resistance, allowing each component to optimize its local function while working together as a unified system
3Manufacturing precision
If pigment ink is used for surgical marking, then the ink resists smearing, but sterility after gamma-ray irradiation is not guaranteed affecting writing properties
Solution Approach 1:
The patent adjusts the chemical composition parameters of the ink, specifically selecting carbon black pigment and water-soluble organic solvents with stability against gamma-ray irradiation, and optimizing the formulation to maintain sterility while preserving writing properties after sterilization treatment
4Device complexity
If dipping pen type is used for surgical marking, then the pen is simple in structure, but it requires repeated ink replenishing and careful floating of pen tip to prevent damage
Solution Approach 1:
The patent designs a surgical pen with an ink storage chamber and ink delivery mechanism that automatically supplies ink to the writing tip, eliminating the need for manual ink replenishment and allowing continuous marking operations without interrupting the surgical procedure
Solution Approach 2:
The patent pre-fills the pen with sufficient ink capacity before the surgical procedure, allowing the surgeon to perform multiple marking operations without needing to refill during the procedure, thereby improving ease of operation while maintaining simple structure
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 ink maintains stable writing properties and biocompatibility, preventing ink smearing and ensuring correct marking on wet surfaces, while the pen provides stable ink discharge and reduces damage to tissues.
Implementation Method 1
a surgical ink containing an activated carbon powder and a water-soluble organic solvent
Implementation Method 2
5 to 25 parts by weight of the water-soluble organic solvent
Data Source
AI summary
A surgical ink is suitable for medical devices that ensure safety in accordance with the sterilization validation and can be widely distributed on the market, and has biocompatibility and writing property, and a surgical pen has good writing convenience. A surgical pen having radiation resistance includes: a cylindrical shaft body portion having a storage part for a surgical ink; and a pen tip portion for discharging the ink at a distal end of the shaft body portion, and the pen tip portion is made of a synthetic resin, and has a bending strength of 1.0 N or more after irradiation with γ-rays of 25 kGy to 70 kGy.