Limited Reuse Ablation Needle Clocking Mechanism
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Solution Overview
Problem
Ablation devices with disposable needles face issues of dullness and deformation after repeated use, making them difficult to place and operate effectively, necessitating the development of a system that limits the number of uses to ensure consistent performance and prevent misuse.
Innovation Solution
A surgical instrument featuring a reusable component and a limited-use component with a clocking mechanism that counts each engagement, transitioning from usable states to a spent state to prevent further use, including a hub and housing configuration for incremental rotation and display of remaining uses, ensuring the limited-use component is replaced when exhausted.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Loss of substance
If needles are reused multiple times, then device cost is reduced, but needle performance deteriorates (dullness, bending, deformation)
Solution Approach 1:
The patent implements a disposable needle design where the needle is intended for single-use only. After one use, the needle is discarded and replaced with a new sterile needle. This eliminates issues of needle dullness, bending, and deformation that occur with repeated use, while the low cost of individual needles makes the disposable approach economically viable. The system includes a replaceable needle cartridge that can be quickly exchanged by the practitioner.
Solution Approach 2:
The patent incorporates a needle usage counter that tracks the number of times a needle has been used. When the needle reaches its predetermined usage limit (typically one use), the counter triggers an indication to discard the needle and insert a fresh one. This systematic approach ensures needles are replaced before performance degradation occurs, maintaining reliable operation while preventing misuse of exhausted needles.
2Reliability
If needles are replaced frequently, then needle performance is maintained, but device complexity increases
Solution Approach 1:
The patent combines the needle, its protective sheath, and the usage counter into a single integrated needle cartridge assembly. This merged design allows the entire needle system to be replaced as one unit, simplifying the replacement process. The practitioner simply removes the entire cartridge and inserts a new one, rather than dealing with separate needle, holder, and counter components. This integration maintains needle performance through regular replacement while minimizing the increase in device complexity.
Solution Approach 2:
The needle cartridge includes an automatic usage counter that self-registers each needle insertion and usage event without requiring manual input from the practitioner. The counter automatically triggers replacement indications based on predetermined usage limits. This self-service mechanism reduces the operational burden on the user and simplifies the overall system by eliminating the need for manual tracking or complex replacement protocols.
3Reliability
If usage limiting mechanisms are added, then needle misuse is prevented, but device complexity increases
Solution Approach 1:
The patent incorporates a usage counter that provides real-time feedback to the practitioner about how many times the needle has been used. The counter displays the current usage count and provides visual or tactile feedback when the needle approaches its usage limit. This feedback mechanism prevents misuse by clearly indicating when a needle should be replaced, without requiring complex mechanical or electronic control systems. The feedback is simple, intuitive, and directly tied to the needle's actual usage state.
Solution Approach 2:
The needle cartridge is pre-configured with a usage counter set to a predetermined usage limit (typically one use). Before the needle is even used, the system is prepared to automatically track and limit its usage. This preliminary configuration ensures that misuse prevention is built into the device from the outset, rather than requiring complex added mechanisms. The predetermined limit is hard-coded into the cartridge design, making misuse prevention a fundamental feature rather than an added complexity.
Data Source
AI summary
A surgical instrument includes a reusable component and a limited-use component releasably engagable with the reusable component. The limited-use component is configured for one or more uses and includes a clocking mechanism configured to count each engagement of the reusable component and the limited-use component to one another. The clocking mechanism is incrementally transitionable upon each successive count from one or more uses state, wherein the clocking mechanism permits both mechanical engagement and electrical coupling of the reusable component and the limited-use component to one another, to a spent state, wherein the clocking mechanism inhibits both mechanical engagement and electrical coupling of the limited-use component and the reusable component to one another.