Cryosurgical Probe Authentication for Single-Use Tip Safety
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Solution Overview
Problem
The reuse of detachable medical tips, such as cryogenic needles, poses safety risks due to dulling, inability to be safely sterilized, and the production of unauthorized, potentially faulty tips, leading to patient injury and infection.
Innovation Solution
A secure microprocessor system is implemented in both durable and disposable medical devices, utilizing PKI-based authentication and cryptographic techniques to ensure the authenticity and authorized use of disposable tips, preventing unauthorized use and ensuring safe operation.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Loss of substance
If detachable tips are reused to reduce waste and cost, then resource utilization improves, but patient safety deteriorates due to dulling, contamination, and infection risks
Solution Approach 1:
The patent implements a disposable detachable tip design where each tip is single-use and discarded after one procedure. This eliminates the need to reuse tips, thereby preventing dulling, contamination, and infection risks while maintaining cost-effectiveness through automated dispensing and integration with the treatment device.
Solution Approach 2:
The system incorporates authentication mechanisms and tracking systems that verify the legitimacy and usage status of each detachable tip. The device receives feedback about tip condition and usage history, preventing the reuse of compromised tips and ensuring only authorized, undamaged tips are employed in patient treatments.
2Reliability
If detachable tips are made disposable to ensure safety, then patient safety improves, but device complexity increases due to authentication and security systems
Solution Approach 1:
Instead of physically securing each tip, the system creates digital copies and authentication records of tip information. Unique identifiers, cryptographic signatures, and usage logs are stored and verified electronically, simplifying the authentication process while maintaining security against counterfeit and reused tips.
Solution Approach 2:
The patent introduces an intermediary authentication system that mediates between the disposable tip and the treatment device. This intermediary layer verifies tip legitimacy, tracks usage history, and ensures proper disposal, thereby enhancing safety without requiring complex direct integration between all system components.
3Reliability
If authentication protocols are implemented to prevent counterfeit tips, then system security improves, but manufacturing and operational costs increase
Solution Approach 1:
The authentication and security features are embedded into the detachable tip during the manufacturing process. Unique identifiers, cryptographic keys, and authentication markers are pre-programmed into each tip before disposal, eliminating the need for additional authentication steps at the point of use and reducing operational costs while maintaining high security.
Data Source
AI summary
A method for cryogenically treating tissue. A connection is detected between a probe having a disposable secure processor (DSP) to a handpiece having a master control unit (MCU) and a handpiece secure processor (HSP), the probe having at least one cryogenic treatment applicator. The probe is fluidly coupled to a closed coolant supply system within the handpiece via the connection. An authentication process is initiated between the DSP and the HSP using the MCU. As a result of the authentication process, one of at least two predetermined results is determined, the at least two predetermined results being that the probe is authorized and non-authorized.