Implantable Neurostimulator Data Storage for Programming Independence

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Solution Overview

Problem

The lengthy and labor-intensive process of programming implantable neurostimulators, such as Deep Brain Stimulation systems, is exacerbated by the lack of patient-specific data availability during subsequent programming sessions, often requiring the same computerized programming system used during implantation, which is not always accessible.

Innovation Solution

A method and system for storing patient-specific imaging-related data in portable components like the implantable neurostimulator, remote controller, or external charger, allowing for telemetric control and programming without prior knowledge of patient-specific data, using imaging data and transformation procedures to generate patient-specific anatomical atlases for optimizing stimulation parameters.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Loss of information

If patient-specific imaging data is stored only in the initial computerized programming system, then programming can be performed with full access to patient-specific data, but subsequent programming sessions cannot access this data when the initial system is unavailable

Engineering Contradiction:

Improvepatient-specific data availabilityVSAvoidprogramming system dependency

Core Design Contradiction:

Loss of informationVSAdaptability or versatility

Solution Approach 1:

The patent extracts patient-specific imaging data and registration information from the initial computerized programming system and stores it in the portable implantable neurostimulator device. This extraction allows the data to be accessed independently of the original programming system, resolving the contradiction between data availability and system dependency.

Inventive Principle:

Principle #2Taking out (Extraction)

Solution Approach 2:

The implantable neurostimulator is designed to serve multiple functions: it not only delivers electrical stimulation but also stores patient-specific imaging data, registration information, and lead electrode location data. This multi-functionality allows the device to act as a portable programming system, eliminating dependency on external systems.

Inventive Principle:

Principle #6Universality (Multi-functionality)

2Measurement precision

If comprehensive patient-specific data is collected and processed during each programming session, then optimization of stimulation parameters is improved, but the time and complexity of programming sessions increases

Engineering Contradiction:

Improvestimulation parameter optimizationVSAvoidprogramming session duration

Core Design Contradiction:

Measurement precisionVSLoss of time

Solution Approach 1:

The patent performs data collection, image processing, and registration procedures during the initial implantation surgery, storing the results in the implantable device. This preliminary action eliminates the need to repeat these time-consuming procedures during subsequent programming sessions, reducing programming time while maintaining optimization capability.

Inventive Principle:

Principle #10Preliminary action

Solution Approach 2:

The implantable neurostimulator contains a copy of the patient-specific imaging data, registration information, and lead electrode location data. This copy allows the device to function as a standalone programming system that provides full access to patient-specific information without requiring the original programming system or repeated imaging procedures.

Inventive Principle:

Principle #26Copying

3Reliability

If the same computerized programming system is required for all programming sessions, then consistency in programming capabilities is maintained, but accessibility and flexibility of subsequent sessions is reduced

Engineering Contradiction:

Improveprogramming consistencyVSAvoidprogramming accessibility

Core Design Contradiction:

ReliabilityVSEase of operation

Solution Approach 1:

The implantable neurostimulator is designed to be self-sufficient by storing all necessary patient-specific data, imaging information, and registration data internally. This self-service capability allows any compatible programming system to access the data without requiring the original system, improving accessibility while maintaining data consistency through standardized storage formats.

Inventive Principle:

Principle #25Self-service

Data Source

PatentEP2879757B1Systems and methods for storing and transferring registration, atlas, and lead information between medical devices

Publication Date: 2019.06.26 BOSTON SCI NEUROMODULATION CORP

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AI summary

A neurostimulator system includes a portable component configured for storing patient-specific data, and an external control device configured for obtaining the patient-specific data from the portable component. The portable component is an implantable neurostimulator, a patient's remote controller, and/or an external charger. The patient-specific data is imaging-related data. A method of storing data in a neurostimulation system includes generating patient-specific data, and storing the patient-specific data in at least one of the portable components. A method for programming the implantable neurostimulator includes receiving the patient-specific data from the portable component, simulating a volume of tissue activation for each of one or more candidate stimulation parameters, wherein the simulation is based at least in part on the patient-specific data, selecting at least one of the candidate stimulation parameters, and programming the implantable neurostimulator with the selected stimulation parameters.