Fluorophore-Tagged Surgical Articles for Retained Item Detection
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Solution Overview
Problem
Current methods for detecting retained surgical items (RSIs) during surgeries, such as x-ray tags, RFID, and data-matrix-coded sponges, suffer from high false-negative rates and are costly, failing to adequately prevent the severe consequences of retained surgical items, including complications and legal ramifications.
Innovation Solution
Surgical articles are developed with a fluorophore, specifically near-infrared (NIR) agents or fluorescent proteins affixed to various materials, allowing for detection within the body cavity using excitation light sources, providing a safer and more effective means to identify and retrieve inadvertently left items.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Measurement precision
If x-ray tags are used to detect retained surgical items, then detection capability is improved, but patient safety deteriorates due to ionizing radiation exposure
Solution Approach 1:
The patent replaces x-ray detection (ionizing radiation) with optical detection using fluorophores that emit visible or near-infrared light when excited by non-ionizing light sources. This substitution eliminates radiation exposure while maintaining detection capability through fluorescent signal emission from surgical articles containing the fluorophore markers.
Solution Approach 2:
The patent utilizes fluorophores that exhibit color changes or light emission properties when excited. These fluorophores absorb light at one wavelength and emit at a different wavelength, creating a detectable optical signal that allows identification of surgical items without using ionizing radiation. The color/light emission property enables safe optical detection替代x-ray.
2Measurement precision
If RFID tags are used to detect retained surgical items, then detection capability is improved, but manufacturing cost deteriorates
Solution Approach 1:
The patent employs fluorophore markers that can be integrated into disposable surgical articles at low cost. These fluorophores are inexpensive chemical compounds that can be incorporated during manufacturing, replacing expensive RFID chips while maintaining detection functionality through optical means. The disposable nature of surgical articles aligns with the low-cost fluorophore approach.
Solution Approach 2:
The patent changes the detection parameter from radio-frequency signals (RFID) to optical fluorescence signals. This parameter change allows the use of simpler, cheaper materials (fluorophores) instead of complex electronic RFID tags, significantly reducing manufacturing costs while preserving detection capability through optical excitation and emission.
3Measurement precision
If data-matrix-coded sponges are used to detect retained surgical items, then detection capability is improved, but device complexity deteriorates
Solution Approach 1:
The patent extracts the essential detection function from complex barcode/RFID systems and implements it through simple fluorophore markers. By removing the need for barcode printing, scanning hardware, and complex data-matrix encoding systems, the invention achieves detection capability through a single optical component (fluorophore) that emits light when excited, dramatically simplifying the overall system.
Solution Approach 2:
The patent uses fluorophores as optical copies or analogs of the information-carrying elements in barcode systems. Instead of encoding information in visual barcodes that require scanning, the fluorophore's optical emission properties directly provide detectable identification, eliminating the need for complex scanning and decoding infrastructure while maintaining detection functionality.
4Measurement precision
If strategic counting is performed to prevent retained surgical items, then detection capability is improved, but reliability deteriorates due to human error
Solution Approach 1:
The patent implements a self-detecting system where surgical articles with fluorophores automatically emit detectable optical signals when exposed to excitation light. This eliminates the need for manual counting by surgical staff, as the fluorophore-marked items self-identify through their optical emission properties, providing reliable detection independent of human attention or counting accuracy.
Solution Approach 2:
The patent creates a feedback system where the presence of surgical items is continuously detectable through fluorophore emission. The optical detection system provides real-time feedback about the presence and location of marked surgical articles, replacing the one-time manual counting process with ongoing detectable confirmation that prevents retained items regardless of initial counting accuracy.
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 use of NIR agents or fluorescent proteins enhances detection accuracy and safety by offering a non-ionizing radiation method with high signal-to-background ratios, reducing the incidence of retained surgical items and associated complications.
Implementation Method 1
a fluorophore selected from a near infrared (NIR) agent or a fluorescent protein... offering a non-ionizing radiation method with high signal-to-background ratios
Data Source
Figure 1A~2B
Figure 3A~4B
Figure 5A~7C
AI summary
Provided herein are articles that comprise a fluorophore (such as a near infrared (NIR) agent or a fluorescent protein) affixed to a surgical article. Methods of detecting the surgical article within the body cavity of a subject are also provided. In some aspects, the detection of a surgical article left within the body cavity of the subject can occur prior to closing the body cavity after a surgical procedure. Methods of making the surgical articles are also provided.