Programming History Guidance for Neurostimulator Therapy
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Solution Overview
Problem
The process of programming medical devices for therapy delivery is time-consuming and inefficient, often requiring extensive trial and error due to the large number of possible parameter combinations, especially in implantable neurostimulators, leading to inadequate initial programs and the need for repeated follow-up sessions.
Innovation Solution
A programming device that maintains a history of tested programs and their outcomes, providing guidance to clinicians by analyzing and displaying this data to quickly identify desirable programs, reduce redundant testing, and suggest new parameter combinations based on previous results.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If manual trial and error testing of numerous parameter combinations is performed, then adequate therapy programs can be discovered, but the programming process becomes extremely time-consuming
Solution Approach 1:
The system performs preliminary testing and evaluation of parameter combinations automatically before the clinician needs to review them. The processor automatically executes multiple parameter combinations, records outcomes, and prepares results for review, thereby performing the time-consuming trial and error process in advance during less critical times.
Solution Approach 2:
The system implements feedback loops where outcomes from each parameter combination test are recorded and used to guide subsequent testing. The system learns from previous results and adjusts future testing strategies, providing continuous feedback that improves the efficiency of finding adequate therapy programs while reducing redundant testing.
2Reliability
If the number of electrode combinations to be tested is increased to improve therapy outcomes, then better therapy efficacy can be achieved, but the complexity of the programming process increases substantially
Solution Approach 1:
The system performs self-service by automatically executing the testing of multiple electrode combinations without requiring manual intervention for each test. The processor autonomously manages the complex coordination of multiple electrodes, parameter adjustments, and outcome recording, thereby reducing the complexity burden on the clinician while maintaining comprehensive testing.
Solution Approach 2:
The processor acts as an intermediary between the clinician's therapeutic goals and the complex electrode configuration space. It translates high-level therapy objectives into specific parameter combinations to test, manages the complexity of coordinating multiple electrodes, and presents simplified results to the clinician, thereby mediating between therapy efficacy requirements and programming complexity.
3Reliability
If extensive testing of parameter combinations is performed during initial programming, then better programs can be identified, but the number of follow-up programming sessions increases due to inadequate initial programming
Solution Approach 1:
The system maintains continuous accumulation of programming data across multiple sessions. Programming history and outcome data are stored and reused, allowing the system to build upon previous testing rather than starting anew each session. This continuity improves initial program quality while increasing overall efficiency by eliminating redundant testing across sessions.
4Loss of information
If manual recording of programming notes and outcomes is performed, then programming history can be maintained, but the time required for data entry and retrieval increases
Solution Approach 1:
The system replaces the mechanical process of manual note-taking and paper-based record keeping with an automated electronic data management system. The processor automatically records, stores, and retrieves programming data and outcomes, eliminating the time-consuming manual data entry while maintaining comprehensive programming history through digital storage and retrieval capabilities.
Data Source
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AI summary
A programming device used to program delivery of therapy to a patient by a medical device, such as an implantable neurostimulator or pump, maintains or accesses a programming history for the patient. The programming history may take the form of a record of programs, e.g., combinations of therapy parameters, tested during one or more prior programming sessions. The programming device may analyze, or otherwise use the programming history to provide guidance information to a user, such as a clinician, which may assist the user in more quickly identifying one or more desirable programs during a current programming session.