Modular Surgical Instrument Assembly for Sterile Component Reuse
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Solution Overview
Problem
Existing surgical instruments and systems face challenges in maintaining sterility during assembly and disassembly, particularly when components come into contact with patient tissues and fluids, leading to contamination and complications in processing for disposal, reuse, or remanufacturing.
Innovation Solution
A modular surgical system with a hub enclosure that integrates generator, smoke evacuation, and suction/irrigation modules, along with a surgical kit and tool assembly that facilitates easy assembly and disassembly of instruments, ensuring sterility and enabling efficient harvesting of high-value components.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If surgical instruments are assembled and disassembled manually in traditional settings, then ease of operation is improved, but sterility is compromised due to contamination from patient tissues and fluids
Solution Approach 1:
The surgical instrument is divided into distinct modular components including a reusable generator module and disposable instrument modules. This segmentation allows the sterile field to be maintained by replacing only the disposable portions that contact patient tissues, while the reusable generator remains outside the sterile field.
Solution Approach 2:
The generator module is extracted from the sterile field and placed outside it, while only the essential instrument portions that require sterility are placed within the sterile field. This extraction allows assembly and disassembly to occur in a controlled manner that maintains sterility boundaries.
2Reliability
If surgical instruments are designed as integrated units, then reliability is improved, but device complexity increases making assembly and disassembly difficult
Solution Approach 1:
The instrument is segmented into modular components (generator module, instrument module, end effector) that can be independently manufactured, tested, and assembled. Each module maintains its functional integrity while allowing simplified assembly through standardized coupling mechanisms.
Solution Approach 2:
The generator module is designed as a universal platform that can interface with multiple different instrument modules through standardized connections. This universality simplifies the overall system architecture and makes assembly more straightforward while maintaining reliable performance across different instrument configurations.
3Reliability
If surgical instruments are made disposable, then sterility is maintained, but loss of substance increases due to disposal of high-value components
Solution Approach 1:
The instrument is segmented into disposable portions (instrument module, end effector) that contact patient tissues and are discarded, and reusable portions (generator module) containing high-value components that remain outside the sterile field and can be reused.
Solution Approach 2:
Only the portions of the instrument that actually contact patient tissues are designed as disposable short-living components, while the high-value generator module is designed for reuse. This selective disposability maintains sterility requirements while preserving valuable components.
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 reduces entanglement of fluid, power, and data lines, simplifies assembly and disassembly processes, and promotes sterile handling, while allowing for effective recycling and reuse of valuable components.
Implementation Method 1
one or more piezoelectric elements that convert electrical power into ultrasonic vibrations
Implementation Method 2
a blade element that vibrates at ultrasonic frequencies to cut and/or seal tissue (e.g., by denaturing proteins in tissue cells)
Implementation Method 3
Some instruments are operable to seal tissue by applying radiofrequency (RF) electrosurgical energy to the tissue
Data Source
Figure 1
Figure 2
Figure 3~4
AI summary
A surgical kit and related methods of assembly and disassembly include a surgical instrument having an end effector, a shaft assembly, and a body assembly. The surgical instrument includes a predetermined access portion (3035) configured to be at least partially removed for accessing an interior therein. The surgical kit also includes an instrument tool assembly (3022) with a tool body, a torque wrench connected to the tool body, and a removal portion for gaining access to the interior of the surgical instrument.