Automated Phrenic Nerve Stimulation Testing for Cardiac Pacing

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Solution Overview

Problem

Current methods for cardiac pacing therapies, such as CRT, are time-consuming and burdensome for clinicians due to the need for extensive testing of multiple electrode vectors to avoid phrenic nerve stimulation and determine optimal pacing capture thresholds, which can lead to inefficient selection of pacing vectors.

Innovation Solution

An automated system and method for performing phrenic nerve stimulation and pacing capture threshold testing using an implantable medical device (IMD) that simultaneously evaluates cardiac pacing capture thresholds and phrenic nerve stimulation, allowing for efficient selection of pacing vectors that minimize undesired stimulation.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Measurement precision

If multiple electrode vectors are tested manually for pacing capture threshold and phrenic nerve stimulation, then accurate vector selection is achieved, but the testing process becomes time-consuming and burdensome

Engineering Contradiction:
Improvepacing capture threshold measurementVSAvoidtesting time
Core Design Contradiction:
Measurement precisionVSLoss of time

Solution Approach 1:

The system performs preliminary automated testing of all electrode vectors for both pacing capture threshold and phrenic nerve stimulation before final vector selection. This preliminary comprehensive assessment eliminates the need for manual iterative testing, reducing overall testing time while maintaining measurement accuracy through systematic evaluation of all vectors.

Inventive Principle:
Principle #10Preliminary action

Solution Approach 2:

The IMD automatically performs the testing process without requiring continuous clinician intervention. The device self-manages the evaluation of multiple electrode vectors, automatically detecting pacing capture thresholds and phrenic nerve stimulation, thereby reducing the burden on clinicians while maintaining precise measurements.

Inventive Principle:
Principle #25Self-service

2Reliability

If multiple electrode vectors are tested for both cardiac response and phrenic nerve stimulation, then comprehensive vector evaluation is achieved, but the complexity of the testing process increases

Engineering Contradiction:
Improvevector selection reliabilityVSAvoidtesting process complexity
Core Design Contradiction:
ReliabilityVSDevice complexity

Solution Approach 1:

The system merges the evaluation of pacing capture threshold and phrenic nerve stimulation into a single integrated automated testing process. By combining these two assessments that were previously performed separately, the system achieves comprehensive vector evaluation while reducing overall process complexity through unified automated control.

Inventive Principle:
Principle #5Merging (Combining)

Solution Approach 2:

The testing system is designed to perform multiple functions simultaneously - evaluating both cardiac pacing response and phrenic nerve stimulation across all electrode vectors. This multi-functional approach ensures reliable vector selection by comprehensively assessing all relevant parameters through a single automated process.

Inventive Principle:
Principle #6Universality (Multi-functionality)

3Manufacturing precision

If extensive testing of multiple electrode vectors is performed, then optimal pacing vector selection is achieved, but the burden on the patient increases due to repeated testing

Engineering Contradiction:
Improvepacing vector selection precisionVSAvoidpatient comfort
Core Design Contradiction:
Manufacturing precisionVSEase of operation

Solution Approach 1:

The system performs all necessary preliminary automated testing of electrode vectors in a single comprehensive session before implantation or programming. This preliminary evaluation of all vectors eliminates the need for repeated patient testing later, achieving precise vector selection while minimizing patient burden through one-time comprehensive assessment.

Inventive Principle:
Principle #10Preliminary action

Solution Approach 2:

The IMD automatically performs the extensive testing required for precise vector selection without requiring repeated patient visits or manual clinician testing. The device self-manages the evaluation process, achieving accurate vector determination while reducing patient burden by consolidating all necessary assessments into automated procedures.

Inventive Principle:
Principle #25Self-service

Data Source

PatentUS9498631B2Automated phrenic nerve stimulation and pacing capture threshold test
Publication Date: 2016.11.22 MEDTRONIC INC
  • US9498631B2 patent drawing
  • US9498631B2 patent drawing
  • US9498631B2 patent drawing

AI summary

A medical device system and method for determining pacing threshold data that includes a cardiac capture sensor, a phrenic nerve stimulation sensor, a pulse generator selectively coupled to a plurality of electrode vectors to deliver a pacing stimulation pulse, and a processor coupled to the cardiac capture sensor, the phrenic nerve stimulation sensor and the pulse generator and configured to deliver the pacing simulation pulse along the plurality of electrode vectors, determine, for each vector of the plurality of vectors, a pacing capture threshold in response to the delivered pacing pulse, deliver a phrenic nerve stimulation pulse along only the vectors of the plurality of vectors that the determined pacing capture threshold is less than a predetermined pacing capture threshold limit, and determine whether phrenic nerve stimulation is detected in response to the delivered phrenic nerve stimulation pulse.