Removable Data Module for Electrosurgical Tool Sterilization
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Solution Overview
Problem
Powered surgical tools face challenges in incorporating electronic components that can withstand sterilization processes, as these components often lose functionality due to the high temperatures, moisture levels, and pressures associated with sterilization techniques.
Innovation Solution
A data module for surgical instruments that is removably attached to electrosurgical tools, featuring a light, memory, and communication mechanism, allowing for real-time data collection and communication of tool conditions, patient data, and operational parameters, while being disposable to avoid repeated sterilization damage.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Adaptability or versatility
If electronic components are integrated into powered surgical tools to provide benefits like data tracking and user feedback, then functionality and productivity are improved, but the components cannot withstand sterilization temperatures, moisture levels, and pressures, causing loss of functionality
Solution Approach 1:
The surgical tool is divided into sterilizable components (surgical instrument, housing) and non-sterilizable electronic components (display, circuit board, battery). The electronic components are separated into a distinct assembly that can be independently handled, allowing the surgical portions to undergo sterilization while the electronic portions are protected from sterilization exposure.
Solution Approach 2:
A barrier film or protective enclosure acts as an intermediary between the electronic components and the sterilization environment. This intermediary layer prevents direct exposure of sensitive electronics to autoclave temperatures, moisture, and pressure, while still allowing the surgical tool to be properly sterilized.
2Reliability
If hermetic sealing is used to protect electronic components during sterilization, then reliability is improved, but manufacturing complexity and cost increase
Solution Approach 1:
Rather than hermetically sealing the entire surgical tool, the design segments the tool into sterilizable and non-sterilizable portions. This eliminates the need for complex hermetic sealing across the entire device while still protecting electronic components through physical separation and selective sterilization protocols.
3Reliability
If electronic components are made sterilization-resistant through special materials or sealing, then reliability is improved, but manufacturing complexity and cost increase
Solution Approach 1:
The design avoids the need for specialized sterilization-resistant materials by physically separating electronic components from the sterilization process. Standard electronic components can be used without modification, as they are housed in a separate assembly that does not undergo autoclaving or other sterilization methods.
Solution Approach 2:
The electronic component assembly may be designed as a disposable or single-use unit that is discarded after sterilization of the surgical tool, eliminating the need for expensive sterilization-resistant materials. Alternatively, the electronic assembly can be replaced periodically without subjecting it to sterilization.
Data Source
AI summary
In general, data modules for surgical instruments and methods of using data modules for surgical instruments are provided. In an exemplary embodiment, a data module is configured to be removably attached to a powered surgical tool such as an electrosurgical tool. The data module is a standalone device including electronic components that are configured to, with the data module attached to the electrosurgical tool, interact with the electrosurgical tool.