Remote Neurostimulator Programming System Safety Verification

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Solution Overview

Problem

Current medical devices, such as neurostimulation systems, require in-person programming by healthcare professionals, which can be inconvenient and costly for patients, and may not account for individual variations in anatomy and pain levels, leading to suboptimal treatment outcomes.

Innovation Solution

A remote medical device programming system that allows authorized users to adjust programmable features of implantable or wearable neurostimulators, including electrode selection and stimulation parameters, using a network-connected system that ensures safety thresholds are met, enabling remote diagnostics and programming adjustments based on patient feedback.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If in-person programming by healthcare professionals is used, then safety and proper configuration are ensured, but patient convenience deteriorates and healthcare costs increase

Engineering Contradiction:
ImprovesafetyVSAvoidpatient convenience
Core Design Contradiction:
ReliabilityVSEase of operation

Solution Approach 1:

A remote programming system acts as an intermediary between the healthcare professional and the implantable device. The system includes a programming device that communicates with the implantable device through a communication interface, allowing configuration changes to be made remotely without requiring the patient's physical presence with the healthcare provider.

Inventive Principle:
Principle #24Intermediary (Mediator)

Solution Approach 2:

The patent replaces the mechanical/physical presence requirement with an electronic communication system. The programming device uses software and communication protocols to transmit configuration data to the implantable device, substituting the need for in-person physical interaction with the device and patient.

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

2Reliability

If in-person programming by healthcare professionals is used, then proper configuration is ensured, but healthcare costs increase

Engineering Contradiction:
Improveproper configurationVSAvoidhealthcare costs
Core Design Contradiction:
ReliabilityVSLoss of energy

Solution Approach 1:

The remote programming system serves as an intermediary that enables configuration changes without requiring expensive in-person healthcare provider visits. The system includes a programming device with communication capabilities that can update implantable device parameters remotely, reducing the need for costly physical consultations.

Inventive Principle:
Principle #24Intermediary (Mediator)

Solution Approach 2:

The system creates a digital copy or representation of the programming interface that can be accessed remotely. The programming device replicates the configuration capabilities available to healthcare providers, allowing them to make adjustments without physical presence, thereby reducing travel and facility costs.

Inventive Principle:
Principle #26Copying

3Adaptability or versatility

If standard programming approaches are used, then general applicability is maintained, but individual patient variations are not accounted for, leading to suboptimal outcomes

Engineering Contradiction:
Improveindividual patient adaptationVSAvoidprogramming system complexity
Core Design Contradiction:
Adaptability or versatilityVSDevice complexity

Solution Approach 1:

The programming system enables dynamic adjustment of device parameters based on individual patient needs. The implantable device and programming device can exchange data to allow real-time or near-real-time configuration changes tailored to each patient's specific condition, anatomy, and response to therapy, moving from static to dynamic programming.

Inventive Principle:
Principle #15Dynamics

Solution Approach 2:

The system incorporates feedback mechanisms where the implantable device can transmit performance data and patient response information back to the programming device. This feedback loop allows the system to adapt programming parameters based on actual patient outcomes, enabling continuous optimization for individual patients.

Inventive Principle:
Principle #23Feedback

Data Source

PatentEP3337557B1Remote access and post program telemonitoring
Publication Date: 2020.08.19 BOSTON SCI NEUROMODULATION CORP
  • EP3337557B1 patent drawingFigure 1~2
  • EP3337557B1 patent drawingFigure 3~4
  • EP3337557B1 patent drawingFigure 5

AI summary

A system may include a therapy controller including a telemetry circuit configured to communicate with an implantable or wearable medical device and a processor configured to execute instructions relating to programming the implantable medical device, and a communication circuit operatively coupled to the therapy controller and configured to transfer information between the therapy controller and a remote device. The therapy controller is configured to receive at least one input relating to operation of the implantable medical device, convert the input into proposed programming instructions, apply device programming rules to verify the safety of the proposed programming instructions, and deliver the programming instructions to the implantable or wearable medical device. In an example, the therapy controller is also configured to deliver information about the programming and data from the IPG, such as various data reporting on the IPG status to a remote device using the communication circuit.