Implantable Stimulation Control Module Personalization

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Solution Overview

Problem

Current implantable electrical stimulation systems lack an efficient method for personalizing and optimizing stimulation programs based on individual patient feedback and characteristics, leading to suboptimal treatment efficacy and potential side effects.

Innovation Solution

A system that includes a processor-enabled implantable control module with memory and communication capabilities to store, retrieve, and analyze stimulation programs and parameters, allowing for real-time adjustments and generation of new programs using machine learning algorithms, patient feedback, and remote data aggregation to improve treatment efficacy.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Ease of manufacture

If implantable electrical stimulation systems use standardized stimulation programs, then device complexity is reduced and ease of manufacture is improved, but treatment efficacy and adaptability to individual patients deteriorate

Engineering Contradiction:

Improveease of manufactureVSAvoidtreatment efficacy

Core Design Contradiction:

Ease of manufactureVSReliability

Solution Approach 1:

The system pre-stores multiple stimulation programs and parameters in memory before implantation, covering various clinical scenarios and patient conditions. This preliminary preparation allows the system to quickly adapt to individual patients without requiring complex real-time programming, thus maintaining ease of manufacture while improving treatment efficacy through personalized selection from pre-optimized programs

Inventive Principle:

Principle #10Preliminary action

Solution Approach 2:

The system enables modification of stimulation parameters (amplitude, pulse width, frequency, electrode configuration) to tailor standardized programs to individual patient needs. By allowing parameter adjustments within pre-defined program frameworks, the system maintains manufacturing simplicity while achieving personalized treatment optimization for improved reliability

Inventive Principle:

Principle #35Parameter changes

2Reliability

If implantable electrical stimulation systems collect and analyze patient feedback data, then treatment efficacy and personalization are improved, but device complexity and loss of information increase

Engineering Contradiction:

Improvetreatment efficacyVSAvoiddevice complexity

Core Design Contradiction:

ReliabilityVSDevice complexity

Solution Approach 1:

The system incorporates feedback mechanisms where patient responses (symptom relief, side effects, quality of life metrics) are collected and used to adjust stimulation parameters. This feedback loop enables continuous optimization of treatment efficacy while using structured data collection forms and algorithms to manage complexity systematically

Inventive Principle:

Principle #23Feedback

Solution Approach 2:

The system uses an external programming device and communication interface as intermediaries to handle complex data analysis and processing tasks. The implantable device collects and transmits data, while external systems perform sophisticated analysis and generate optimized programs, reducing the complexity burden on the implantable device itself while maintaining high treatment efficacy

Inventive Principle:

Principle #24Intermediary (Mediator)

3Reliability

If implantable electrical stimulation systems store and transfer large amounts of patient data remotely, then personalization and treatment optimization are improved, but loss of time and device complexity increase

Engineering Contradiction:

Improvetreatment optimizationVSAvoidloss of time

Core Design Contradiction:

ReliabilityVSLoss of time

Solution Approach 1:

The system pre-processes and organizes patient data during implantation and initial programming sessions, storing structured information in memory that can be quickly retrieved and used for personalized treatment. This preliminary data preparation reduces the need for extensive data collection and analysis during follow-up visits, minimizing time loss while enabling continuous optimization

Inventive Principle:

Principle #10Preliminary action

Solution Approach 2:

The system creates and transfers digital copies of stimulation programs and patient data between the implantable device, external programming device, and remote servers. This copying mechanism enables efficient data exchange and cloud-based analysis without requiring continuous physical presence or extensive data transmission time, thus improving treatment optimization while minimizing time loss

Inventive Principle:

Principle #26Copying

Data Source

PatentUS9959388B2Systems, devices, and methods for providing electrical stimulation therapy feedback

Publication Date: 2018.05.01 BOSTON SCI NEUROMODULATION CORP

AI summary

A system for storing stimulation programs or sets of stimulation parameters includes at least one memory; at least one of i) multiple stimulation programs or ii) a multiple sets of stimulation parameters stored on the at least one memory from multiple different devices remote from the system and used to stimulate different patients; at least one processor coupled to the at least one memory to retrieve the stored stimulation programs or sets of stimulation parameters from the at least one memory when requested and to store additional stimulation programs or sets of stimulation parameters on the at least one memory; and a communications arrangement coupled to the at least one processor to deliver the stored stimulation programs or sets of stimulation parameters to external device and to receive additional stimulation programs and sets of stimulation parameters from external devices.