Powered Surgical Instrument Usage Counter and Authentication
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Solution Overview
Problem
Current surgical staplers require significant manual force for clamping and deploying surgical fasteners, leading to user fatigue, and lack advanced sensors for feedback control and parameter adjustment, necessitating improved powered surgical instruments with enhanced user control and feedback mechanisms.
Innovation Solution
A powered surgical instrument featuring a microcontroller with usage and sterilization counters to prevent overuse, combined with authentication mechanisms for components, and sensors for real-time feedback and control, including a non-linear speed control system and articulation mechanism for precise operation.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Ease of operation
If manual force is used to clamp tissue and deploy surgical fasteners, then the surgical instrument can perform stapling operations, but user hand fatigue occurs due to repeated use requiring 10-60 pounds of manual force
Solution Approach 1:
The patent replaces the manual mechanical system with an electric motor-powered system. The motor provides the force needed to clamp tissue and deploy surgical fasteners, eliminating the need for users to apply 10-60 pounds of manual hand force repeatedly. The motorized actuation system includes a motor, drive mechanism, and control circuitry that automatically performs the stapling operations.
Solution Approach 2:
The surgical instrument performs clamping and fastener deployment operations autonomously once activated. The motor-powered system self-actuates the firing mechanisms without requiring continuous manual force application, allowing the instrument to complete stapling cycles independently after initial user activation.
2Ease of operation
If a single switch is used to actuate the motor, then the device is simple to operate, but user control of the stapling process is limited
Solution Approach 1:
The control system transitions from a static single-switch design to a dynamic multi-parameter control system. The motor controller can adjust operating parameters such as firing speed, clamping force, and sequence timing based on surgical conditions, providing adaptable control while maintaining ease of activation through electronic control mechanisms.
Solution Approach 2:
The patent enables control of multiple operational parameters including motor speed, torque, firing sequence timing, and clamping force levels. These parameters can be adjusted to optimize performance for different surgical applications and tissue types, expanding user control capabilities beyond simple on/off switching.
3Reliability
If usage counters and authentication mechanisms are added to prevent reprocessing, then instrument reuse is controlled, but device complexity increases
Solution Approach 1:
The control system incorporates usage counters that track the number of activations and sterilization cycles. This feedback mechanism monitors instrument history and provides data to the authentication system, enabling intelligent decision-making about instrument reuse eligibility without requiring complex manual tracking or external monitoring systems.
Solution Approach 2:
The microcontroller and memory system serve multiple functions: controlling motor operation, tracking usage counters, storing authentication data, and managing sterilization cycle records. By consolidating these functions into a single integrated control unit, the patent reduces overall system complexity compared to having separate dedicated systems for each function.
Data Source
AI summary
A surgical instrument is disclosed. The instrument includes a microcontroller coupled to a memory, the microcontroller is configured to control the surgical instrument and a usage counter stored in the memory that is incremented when the surgical instrument is activated, wherein the microcontroller is further configured to prevent actuation of the surgical instrument when the usage counter is above a predetermined threshold.