Electrode Connection Verification for Implantable Medical Devices

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Solution Overview

Problem

Existing neurostimulation devices face challenges in ensuring consistent electrode connections during the replacement of implantable medical devices, which can lead to ineffective or dangerous stimulation therapy.

Innovation Solution

A system that compares the connected electrode profiles of a prior and current implantable medical device to determine if the electrodes are connected in a similar manner, allowing for the adjustment of stimulation parameters to ensure consistent therapy.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Loss of time

If electrode leads are reused during IPG replacement, then surgical time and patient trauma are reduced, but electrode connection consistency cannot be ensured

Engineering Contradiction:
Improvesurgical timeVSAvoidelectrode connection consistency
Core Design Contradiction:
Loss of timeVSReliability

Solution Approach 1:

The system performs preliminary actions by measuring and storing the impedance profile of electrodes during the initial IPG implantation. When the IPG is replaced, these stored measurements are compared with new measurements to verify that electrode connections remain consistent, allowing the electrode leads to be reused without compromising connection reliability.

Inventive Principle:
Principle #10Preliminary action

Solution Approach 2:

The system implements feedback by continuously monitoring electrode impedance characteristics and comparing them against baseline measurements. If deviations are detected that indicate connection changes, the system provides feedback to alert the operator, enabling corrective action before therapy is compromised.

Inventive Principle:
Principle #23Feedback

2Stability of the object's composition

If stimulation parameters are transferred from prior IPG, then therapy consistency is maintained, but ineffective or harmful stimulation may occur if connections differ

Engineering Contradiction:
Improvetherapy consistencyVSAvoidineffective or harmful stimulation
Core Design Contradiction:
Stability of the object's compositionVSObject-affected harmful factors

Solution Approach 1:

Before transferring stimulation parameters from the prior IPG to the replacement IPG, the system performs preliminary verification by comparing electrode impedance profiles. This preliminary check ensures that electrode connections have not changed, making it safe to transfer the stored stimulation parameters and maintain therapy consistency.

Inventive Principle:
Principle #10Preliminary action

Solution Approach 2:

The system applies preliminary anti-action by preventing parameter transfer when electrode connection changes are detected. The impedance comparison serves as a safeguard that blocks potentially harmful parameter transfers before they can occur, thereby preventing ineffective or harmful stimulation.

Inventive Principle:
Principle #9Preliminary anti-action

3Measurement precision

If manual verification of electrode connections is performed, then connection accuracy can be confirmed, but additional surgical time and complexity are required

Engineering Contradiction:
Improveconnection verification accuracyVSAvoidverification process complexity
Core Design Contradiction:
Measurement precisionVSDevice complexity

Solution Approach 1:

The system replaces manual visual inspection and physical verification of electrode connections with automated electrical impedance measurements. The control circuitry automatically measures impedance characteristics and compares them against baseline data, providing precise connection verification without requiring complex manual procedures or additional surgical steps.

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

Data Source

PatentUS20250041612A1System and Method for Ensuring a Consistent Connection of Electrodes to a Replacement Implantable Medical Device
Publication Date: 2025.02.06 BOSTON SCI NEUROMODULATION CORP
  • US20250041612A1 patent drawing
  • US20250041612A1 patent drawing
  • US20250041612A1 patent drawing

AI summary

Implantable medical devices (IMD) such as those used in Deep Brain Stimulation application are commonly replaced when the device's useful life expires. At the time of replacement, the electrodes that were connected to the initial IMD are typically reused with the replacement IMD. It is desirable for the replacement IMD to utilize the stimulation parameters that were being utilized to provide stimulation in the initial IMD, but it is important that the electrodes be connected to the replacement IMD in a similar manner as they were connected to the initial IMD if stimulation parameters are reused. A connected electrode profile that includes measurements of electrical parameters associated with the electrodes can be generated in the initial IMD and the replacement IMD, and the profiles can be compared to determine whether the electrodes are connected in a similar manner in the replacement IMD as they were in the initial IMD.