Remote Therapy Titration for Implantable Medical Devices
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Solution Overview
Problem
Current medical devices that deliver therapy, such as neurostimulators, require lengthy and burdensome initial programming sessions to determine optimal therapy parameters, often necessitating multiple follow-up sessions due to inadequate initial programming, especially for implantable devices with complex electrode configurations.
Innovation Solution
A method for remotely programming implantable medical devices using data collected by internal or external sensors and patient input, allowing clinicians to adjust therapy parameters or create new programs via a network, reducing the need for in-clinic follow-ups and improving therapy efficacy and side-effect management over time.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Manufacturing precision
If initial programming is performed manually in clinic with trial-and-error testing of parameter combinations, then therapy parameter optimization can be achieved, but the process becomes time-consuming and requires multiple follow-up sessions
Solution Approach 1:
The system performs preliminary testing of therapy parameter combinations automatically before the clinician reviews them. The IMD autonomously cycles through pre-defined parameter sets, collects patient feedback data, and prepares optimized recommendations in advance of the programming session, reducing the time the clinician and patient must spend together.
Solution Approach 2:
An automated programming assistant system acts as an intermediary between the IMD and the clinician. This intermediary handles the time-consuming tasks of automatically testing parameter combinations, analyzing patient feedback, and generating optimized therapy programs, allowing the clinician to focus on final review and patient counseling.
2Manufacturing precision
If multiple electrode combinations are tested to find optimal therapy parameters, then therapy efficacy can be improved, but the complexity of the programming process increases substantially
Solution Approach 1:
The IMD performs self-testing of multiple electrode combinations and parameter sets without requiring manual configuration by the clinician. The device autonomously cycles through pre-programmed test sequences, automatically adjusts parameters, and collects patient feedback, eliminating the need for the clinician to manually manage the complexity of testing numerous electrode configurations.
Solution Approach 2:
The system incorporates real-time patient feedback during automatic parameter testing. Patients provide input about therapy efficacy and side effects, which the programming assistant uses to guide the testing process and identify optimal parameter combinations. This feedback-driven approach simplifies the process by focusing testing on promising configurations rather than requiring exhaustive manual evaluation of all possibilities.
3Manufacturing precision
If comprehensive parameter testing is performed during initial programming, then adequate therapy results can be achieved, but the burden on patient and clinician increases due to multiple required follow-up sessions
Solution Approach 1:
The system performs continuous automatic testing and optimization of therapy parameters between programming sessions. The IMD autonomously monitors therapy effectiveness, collects patient feedback data, and makes incremental adjustments to parameters, maintaining continuous improvement of therapy without requiring repeated clinic visits. This continuous action reduces the burden of multiple follow-up sessions while achieving comprehensive parameter optimization.
Solution Approach 2:
The automated programming assistant serves as an intermediary that handles the burdensome tasks of comprehensive parameter testing and optimization. It automatically manages the complex process of testing multiple parameter combinations, analyzing patient feedback, and generating optimized programs, significantly reducing the time and effort required from both the clinician and patient during programming sessions and follow-ups.
Data Source
AI summary
Techniques for remotely titrating a therapy delivered using an implantable medical device system are disclosed. An implantable medical device delivers therapy according to a first program. The system collects patient data relating to at least one of an efficacy of, or side effects resulting from, the delivered therapy, and transmits the patient data to a remote network device. A clinician may then analyze the patient data and determine if changes to the therapy are warranted. The clinician may then transmit a programming change, e.g., a modification to the first program or a new, second program, to the implantable medical device system, and the implantable medical device may deliver therapy according to the changed programming. The process of receiving patient data and modifying the therapy programming may be repeated multiple times until the therapy is adequately titrated, e.g., until the patient data indicates adequate efficacy and/or acceptable side effects.