Active Fixation Lead Coupling Assessment via Electrical Impedance
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Solution Overview
Problem
Conventional methods for assessing the coupling of leads to tissue, such as fluoroscopic imaging, are subjective and expose patients and clinicians to radiation, while also potentially reducing the useful life of medical devices due to improper placement.
Innovation Solution
A system and method using capacitance, inductance, voltage, or current measurements between an electrode and a fixation element to assess the coupling of a lead to tissue, providing a measurable and less subjective evaluation, thereby minimizing the need for fluoroscopic imaging and reducing radiation exposure.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Measurement precision
If fluoroscopic imaging is used to assess lead coupling, then placement can be visualized, but radiation exposure increases and assessment becomes subjective
Solution Approach 1:
The patent replaces the mechanical/optical fluoroscopic imaging system with an electrical measurement system. Instead of using X-rays to visualize lead placement, the invention uses electrical impedance measurements between the lead electrode and reference electrode to objectively assess coupling. This substitution eliminates radiation exposure while providing quantifiable, objective data about lead-tissue coupling through electrical properties rather than visual imaging.
Solution Approach 2:
The patent introduces electrical impedance as an intermediary parameter to assess lead coupling. Rather than directly observing lead placement through fluoroscopy, the system measures the electrical impedance between the lead electrode and reference electrode, which serves as a mediator that correlates with coupling quality. This intermediary measurement provides objective, quantifiable information without requiring direct visual observation or radiation exposure.
2Measurement precision
If fluoroscopic imaging is used to assess lead coupling, then placement can be visualized, but the assessment becomes subjective
Solution Approach 1:
The patent replaces the complex fluoroscopic imaging system with a simpler electrical measurement system. Instead of requiring X-ray generation, imaging detectors, and image processing infrastructure, the invention uses basic electrical impedance measurement circuits that are already present in most implantable pulse generators. This substitution dramatically reduces system complexity while improving assessment objectivity through quantitative electrical measurements.
Solution Approach 2:
The patent extracts the essential assessment function from the complex fluoroscopic imaging system. Rather than using the entire imaging infrastructure, the invention isolates and measures only the electrical impedance parameter that is relevant to lead coupling assessment. This extraction of the critical measurement function eliminates the need for complex imaging equipment while maintaining assessment capability.
3Productivity
If lead placement is not optimal, then device placement is quick, but device useful life is reduced
Solution Approach 1:
The patent implements immediate feedback about lead coupling quality through electrical impedance measurements. During the placement procedure, the system continuously or periodically measures impedance between the lead electrode and reference electrode, providing real-time information about coupling quality. This feedback allows the operator to adjust lead placement immediately if coupling is insufficient, ensuring optimal placement before device activation and thereby maximizing device useful life without sacrificing placement speed.
Solution Approach 2:
The patent performs preliminary assessment of lead coupling using electrical impedance measurements before final device activation. The system evaluates coupling quality in advance through impedance characterization, allowing optimization of lead placement before the device begins its intended function. This preliminary action ensures that suboptimal placements are corrected before they can compromise device longevity, while maintaining efficient placement procedures.
Applied Scientific Principles
This section explains which scientific principles are used to turn an abstract innovation direction into a practical engineering solution.
Function Achieved in This Case
This approach offers a more objective assessment of lead-tissue coupling, reducing radiation exposure and ensuring optimal device placement, which can extend the useful life of medical devices and improve diagnostic and treatment efficacy.
Implementation Method 1
the use of the capacitance, inductance, voltage or current between the electrode and fixation element provides a measurable quantity indicative of the relative locations of the electrode and fixation element and the degree of coupling of the fixation element to tissue
Implementation Method 2
the use of the capacitance, inductance, voltage or current between the electrode and fixation element provides a measurable quantity indicative of the relative locations of the electrode and fixation element and the degree of coupling of the fixation element to tissue
Data Source
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AI summary
A system (10) and method for assessing coupling of a lead (12) to tissue (14) are provided. The inventive system (10) includes a lead body (24) with an electrode (30) and a fixation element (32) disposed near a distal end (28) of the lead body (24). The fixation element (32) is configured to anchor the distal end (28) of the lead body (24) in the tissue (14). The system (10) further includes a meter (18) configured to generate a signal indicative of an amount of energy between the electrode (30) and the fixation element (32). The amount of energy may comprise capacitance or inductance between the electrode (30) and the fixation element (32). The system (10) further includes an electronic control unit (20) configured to determine a degree of coupling between the lead (12) and the tissue (14) responsive to the signal.