Cardiac Lead Fixation Assessment Using Multi-Variable Analysis
Find Innovative SolutionsGenerate Solutions
Solution Overview
Problem
Existing cardiac pacing leads with helical fixation mechanisms face challenges in determining the precise number of turns of the helix embedded in heart tissue, as individual measurable parameters vary widely between patients, making it difficult to accurately assess fixation quality using simple threshold comparisons.
Innovation Solution
A multi-variable analytic technique is employed to combine measured parameters such as pacing threshold, current of injury, impedance, and R-wave amplitude to determine the number of turns of the helix embedded in heart tissue, using combinatorial analysis and derived multivariate transfer functions to guide lead repositioning during implantation.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Ease of operation
If single parameter threshold comparison is used to determine helix fixation, then the assessment process is simple, but the measurement precision is insufficient due to wide parameter variation between patients
Solution Approach 1:
The patent combines multiple measured parameters (impedance, R-wave amplitude, pacing threshold, current of injury) into a composite assessment to determine helix fixation state. This multi-parameter approach resolves the contradiction by maintaining operational simplicity through integrated analysis while significantly improving measurement precision through the combined information from multiple sources, overcoming the limitations of any single parameter's wide inter-patient variation.
2Measurement precision
If multi-variable analytic technique is used to determine helix turns, then the measurement precision improves, but the device complexity increases
Solution Approach 1:
The patent introduces a computer as an intermediary device that performs the complex multi-variable analysis. The implantable pulse generator measures multiple parameters and stores them in memory, then the computer processes these parameters using multi-variable analytic techniques to determine the number of helix turns embedded in tissue. This intermediary approach resolves the contradiction by handling the analytical complexity externally while providing precise fixation state determination.
Solution Approach 2:
The patent replaces manual trial-and-error mechanical adjustment of lead position with an automated electronic system. The implantable pulse generator, memory system, and computer-based analysis replace the mechanical trial-and-error process, using electrical parameter measurements and computational analysis to precisely determine fixation state, thereby improving measurement precision while managing system complexity through automation.
3Ease of operation
If trial-and-error repositioning is used during lead implantation, then the ease of operation is maintained, but the loss of time increases due to multiple adjustments
Solution Approach 1:
The patent implements a feedback mechanism where the implantable pulse generator continuously measures parameters (impedance, R-wave amplitude, pacing threshold, current of injury) and the computer analyzes these measurements to provide real-time feedback on the number of helix turns embedded in tissue. This feedback allows the operator to immediately assess fixation quality and make informed decisions about whether repositioning is needed, reducing unnecessary trial-and-error adjustments and time loss while maintaining operational simplicity.
Solution Approach 2:
The patent performs preliminary measurement and analysis of multiple parameters during the implantation process itself, rather than requiring post-implantation verification. The implantable pulse generator measures parameters and the computer determines fixation state before final lead placement is confirmed, allowing for immediate correction if needed and preventing time loss from subsequent repositioning requirements.
Data Source
AI summary
Method and systems of determining adequacy of fixation of a medical lead type having a fixation helix are disclosed. The lead of the medical lead type is placed at a desired location within a patient's body and the fixation helix is screwed into tissue at that location. One or more parameters, associated with the lead, are measured at the location. Based upon the measured one or more parameters, determining a number of turns that the helix is embedded into the tissue at the location.