Patient-Specific Safety Interlocks for Medical Devices
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Solution Overview
Problem
Current medical devices, such as implantable medical devices, require extensive training to set appropriate programmable parameters, and the proliferation of healthcare professionals interacting with these devices increases the risk of unsafe settings, potentially harming patients due to the broad operational range.
Innovation Solution
Implementing patient-specific interlocks that deny operational change requests based on analyzed patient function data, using sensors, a controller, and memory to limit programmable ranges and ensure safe therapeutic functions.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Adaptability or versatility
If the operational range of a medical device is made broad to accommodate a wide range of patients and conditions, then the adaptability and versatility of the device is improved, but the risk of harmful settings increases and safety is worsened
Solution Approach 1:
The patent applies local quality by creating patient-specific interlocks that customize the operational parameters based on individual patient characteristics. Instead of a uniform broad range for all patients, each patient receives a tailored set of safe operating parameters derived from their specific physiological data, thus maintaining adaptability while eliminating harmful settings for that particular patient.
Solution Approach 2:
The patent introduces an intermediary system (the interlock mechanism controlled by the processor) that mediates between the broad operational capabilities of the device and the safety constraints required for individual patients. This intermediary automatically enforces patient-specific safety limits based on stored physiological data, preventing direct access to potentially harmful parameter ranges.
2Reliability
If extensive training is required for health care professionals to safely operate medical devices, then the safety and reliability of device operation is improved, but the ease of operation is worsened and accessibility is reduced
Solution Approach 1:
The patent implements self-service by enabling the medical device to automatically determine and enforce safe operating parameters based on stored patient-specific physiological data. The interlock system autonomously evaluates requested parameter changes against patient-specific criteria without requiring the operator to have specialized knowledge, thus maintaining high safety standards while improving ease of operation for a broader range of health care professionals.
3Reliability
If patient-specific interlocks are implemented to limit programmable parameters, then the safety and reliability of device operation is improved, but the device complexity increases
Solution Approach 1:
The patent applies preliminary action by pre-storing patient-specific physiological data and interlock criteria in the device memory before clinical use. During operation, the system simply retrieves and compares against these pre-established parameters, avoiding the need for complex real-time calculations or decision-making. This approach enhances safety through personalized limits while minimizing the operational complexity during actual device use.
Data Source
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AI summary
A medical device is provided that includes an input/output, at least one sensor, a memory, a controller and at least one delivery member. The input/output is configured to provide a communication path to and from the medical device. The at least one sensor is used to monitor at least one patient function. The memory is used to store patient specific data from the at least one sensor and operating parameters of the medical device. The controller is used to control operations of the medical device. The controller is in communication with the at least one sensor, the memory and the input/output. The controller is configured to deny device operational change requests received via the input/output based at least in part on the patient specific data sensed by the at least one sensor.