Segmented Surgical Instrument with Disposable Treatment Tool
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Solution Overview
Problem
Current surgical instrument sterilization methods are costly and time-intensive, particularly for reusable instruments, which can lead to increased hospital and manufacturer expenses, and pose challenges in maintaining sterility and instrument durability due to high temperatures and pressures used in sterilization processes.
Innovation Solution
A handheld instrument assembly comprising a non-sterile handle and a treatment tool with a releasable portion, where the handle is enveloped by a flexible sterile envelope, allowing for easy assembly and disassembly, and the treatment tool can have separate disposable or reusable portions to minimize exposure to sterilization processes, ensuring sterility without compromising instrument durability.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If reusable surgical instruments are sterilized using autoclave or ETO sterilization, then sterility is achieved, but the instrument lifetime is reduced due to high temperatures and pressures causing wearing
Solution Approach 1:
The surgical instrument is divided into a reusable handle and a disposable treatment tool portion. The handle can be reused and sterilized, while the treatment tool with sharp geometries is disposable and does not require repeated sterilization, thus extending the lifetime of the reusable components.
Solution Approach 2:
The treatment tool portion is designed as a disposable component that is discarded after a single use or limited uses. This eliminates the need to subject expensive, complex instruments with sharp geometries to repeated high-temperature sterilization processes that cause wearing and reduce lifetime.
2Reliability
If single-use sterile instruments are used, then sterility is guaranteed, but manufacturing costs increase significantly
Solution Approach 1:
The instrument is segmented into a reusable handle and a disposable treatment tool. Only the treatment tool portion requires sterile packaging and single-use design, while the handle can be reused, thereby reducing overall manufacturing costs compared to making the entire instrument disposable.
Solution Approach 2:
The reusable handle can be used with multiple different treatment tool portions over time. This multi-functionality reduces the need to manufacture multiple complete disposable instruments, lowering overall manufacturing costs while maintaining sterility where required.
3Reliability
If reusable instruments are covered with a sterile bag, then sterility is provided, but the function and handling of the surgical instrument are impaired
Solution Approach 1:
The treatment tool portion is designed as a disposable sterile component that is attached to the handle. This eliminates the need for external sterile bags, as the treatment tool itself maintains sterility through its disposable nature, preserving full functionality and handling characteristics.
4Reliability
If the entire handheld instrument is made disposable, then sterility is ensured, but costs increase and instrument complexity increases
Solution Approach 1:
The instrument is divided into reusable and disposable portions. Only the treatment tool portion that requires sterility is made disposable, while the handle remains reusable. This segmentation reduces overall instrument complexity compared to making the entire assembly disposable, while still ensuring sterility where needed.
Data Source
AI summary
The present disclosure provides a handheld instrument assembly for use in a surgical environment. The assembly includes a non-sterile handle and a treatment tool extending from the handle in a distal direction of the handheld instrument assembly. The treatment tool includes a releasable portion which is releasably attached or attachable to the handle or to an adjoining portion of the treatment tool. The assembly further includes a sterile envelope enveloping the non-sterile handle for being gripped by a user of the handheld instrument assembly. The present disclosure also provides a cover assembly, a handheld instrument, and methods of assembling handheld instrument assemblies for use in a surgical environment.