Therapy Programming Guidance via Stored History

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Solution Overview

Problem

The process of programming medical devices for therapy delivery is time-consuming and inefficient, often requiring trial and error to find optimal parameter combinations, especially for implantable neurostimulators, due to the vast number of possible electrode combinations and the lack of effective record-keeping for previous programming sessions.

Innovation Solution

A programming device that maintains a history of therapy programs and their outcomes, allowing clinicians to analyze and retrieve this data to provide guidance for selecting optimal programs, reduce repetition of unsuccessful tests, and suggest new parameter combinations based on previous results.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If a clinician manually tests combinations of parameter values during programming sessions, then potential therapy programs can be evaluated, but the process becomes time-consuming and repetitive across multiple sessions

Engineering Contradiction:
Improvetherapy efficacyVSAvoidprogramming session time
Core Design Contradiction:
ReliabilityVSLoss of time

Solution Approach 1:

The system performs preliminary actions by automatically analyzing patient response data collected during therapy delivery and pre-identifying optimal parameter combinations before the clinician needs to program the device. This automation of preliminary analysis reduces the time required during actual programming sessions while maintaining reliable therapy selection based on patient-specific responses.

Inventive Principle:
Principle #10Preliminary action

2Adaptability or versatility

If the number of electrodes in the electrode set is increased to provide more therapy options, then treatment versatility improves, but the number of possible electrode combinations increases substantially making programming more complex

Engineering Contradiction:
Improvetherapy customizationVSAvoidprogramming complexity
Core Design Contradiction:
Adaptability or versatilityVSDevice complexity

Solution Approach 1:

The system employs feedback mechanisms by continuously monitoring patient responses to different electrode combinations and using this data to automatically identify which combinations are most effective for each patient. This feedback-driven approach allows the system to manage the complexity of numerous electrode combinations by focusing only on those that demonstrate actual therapeutic benefit, rather than requiring the clinician to manually evaluate all possible combinations.

Inventive Principle:
Principle #23Feedback

Solution Approach 2:

The system automatically adjusts and optimizes parameter values based on analyzed patient response data, transforming the complex task of manually selecting from numerous electrode combinations into an automated parameter optimization process. The system changes parameters dynamically based on what has been learned from previous therapy deliveries and patient responses.

Inventive Principle:
Principle #35Parameter changes

3Loss of information

If the clinician records notes on each tested program during programming sessions, then programming history is preserved, but the record-keeping process adds to the time burden and records may be absent or inadequate during follow-up sessions

Engineering Contradiction:
Improveprogramming historyVSAvoidrecord-keeping time
Core Design Contradiction:
Loss of informationVSLoss of time

Solution Approach 1:

The system performs self-service by automatically collecting, storing, and analyzing patient response data during therapy delivery without requiring manual record-keeping by the clinician. The system autonomously maintains a comprehensive programming history and uses this data to guide future programming decisions, eliminating the time burden of manual documentation while ensuring information is preserved and accessible across multiple sessions.

Inventive Principle:
Principle #25Self-service

Solution Approach 2:

The system replaces the mechanical process of manual note-taking with an automated electronic data collection and analysis system. Instead of clinicians physically recording observations, the system electronically captures patient response data, stores it in a structured format, and automatically retrieves relevant information during follow-up sessions, substituting manual labor with automated information management.

Inventive Principle:
Principle #28Mechanics substitution (Replace mechanical system)

Data Source

PatentUS8694115B2Therapy programming guidance based on stored programming history
Publication Date: 2014.04.08 MEDTRONIC INC
  • US8694115B2 patent drawing
  • US8694115B2 patent drawing
  • US8694115B2 patent drawing

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.