Impedance-Based IMD Fixation Verification
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Solution Overview
Problem
Current medical delivery devices lack a reliable method to verify the efficacious fixation of implantable medical devices (IMDs) to the target site within the body, which is crucial for ensuring proper function and contact with tissue, particularly in thin-walled tissues like the heart.
Innovation Solution
The system employs electrodes to deliver an electrical signal between a deployment device and tissue, analyzing impedance to determine if the IMD is securely fixed by identifying threshold impedance levels, stability, and harmonic signatures, using processing circuitry to indicate successful fixation configurations to the clinician.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If impedance-based verification is implemented to ensure proper fixation of IMDs, then reliability of IMD deployment is improved, but device complexity increases due to additional electrodes and processing circuitry
Solution Approach 1:
The delivery device incorporates electrodes that serve dual purposes: traditional delivery functions and new impedance verification functions. The same electrodes used for IMD deployment also measure impedance to verify fixation, eliminating the need for separate verification hardware and reducing overall device complexity despite adding verification capability.
Solution Approach 2:
The system performs self-verification of fixation status through automated impedance measurement and processing circuitry that automatically analyzes impedance signals to determine whether the IMD is properly fixed to the target site, eliminating the need for manual verification procedures and reducing operational complexity.
2Measurement precision
If multiple fixation configurations are verified through impedance measurement, then precision of deployment verification is improved, but measurement precision requirements increase
Solution Approach 1:
The system uses feedback from impedance measurements to verify fixation configurations. Processing circuitry continuously monitors impedance signals and compares them against predefined thresholds to determine whether the IMD has achieved proper fixation, providing real-time feedback to ensure deployment precision without requiring extremely tight manufacturing tolerances on the impedance thresholds themselves.
Solution Approach 2:
The system verifies different fixation configurations by measuring changes in impedance parameters rather than requiring absolute precision. By monitoring parameter changes (such as impedance magnitude and phase) during deployment and comparing them against thresholds, the system can accurately verify fixation status without requiring extremely precise manufacturing of the threshold values.
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 enhances the ability to ensure proper deployment and fixation of IMDs, improving their functionality and contact with the target tissue, thereby enhancing treatment efficacy and monitoring capabilities.
Implementation Method 1
measuring a impedance of the electrical signal between the first electrode and the second electrode; comparing the measured impedance to a threshold impedance value
Data Source
Figure 1A
Figure 1B
Figure 2A~2B
AI summary
A device for delivering an implantable medical device (IMD) includes an elongated member and a deployment bay configured to house the IMD, the deployment bay defining a distal opening for deploying the IMD out of the deployment bay. The device includes a first electrode located inside the deployment bay during intravascular navigation, a second electrode, and impedance detection circuitry configured to deliver an electrical signal to a path between the first electrode and the second electrode through at least one of a fluid or tissue of the patient. The device also includes processing circuitry configured to determine an impedance of the path based on the signal and control a user interface to indicate when an impedance of the path indicates that at least one of the IMD or the distal opening is in a fixation configuration relative to the target site of the patient.