Lead Implant Efficacy Visualization with 3D Mapping
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Solution Overview
Problem
The implantation of lead systems for pacemakers and other medical devices is hindered by the difficulty in efficiently testing candidate locations due to the two-dimensionality of conventional fluoroscopic images, which can lead to repeated testing and potential damage from multiple fixations, especially in thin-walled heart chambers, and the inability to discern undesirable locations like scar tissue.
Innovation Solution
A system that uses real-time fluoroscopic or other imaging techniques to display lead implant efficacy parameters, such as capture thresholds and mechanical resistance, alongside actual tissue images, with color-coding and icons to highlight acceptable sites, and determines safe distances for active fixation to prevent tissue damage, integrating with 3D mapping systems to track lead positions and orientations.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If conventional fluoroscopic images are used for lead implantation, then the implantation process can be performed, but repeated testing of candidate locations occurs leading to tissue damage
Solution Approach 1:
The patent transitions from two-dimensional fluoroscopic images to three-dimensional anatomical maps that display candidate lead locations and tested locations in 3D space. This dimensional enhancement allows clinicians to clearly distinguish between different spatial locations and prevents accidental re-testing of the same site, thereby avoiding tissue damage from multiple fixations.
Solution Approach 2:
The system provides visual feedback by displaying icons representing tested locations on the 3D anatomical map. When a candidate location is tested, an icon is placed at that location, providing immediate visual feedback to the clinician. This feedback mechanism prevents accidental re-testing by making previously tested locations clearly visible and distinguishable from untested locations.
2Reliability
If conventional fluoroscopic images are used, then lead implantation can proceed, but undesirable locations such as scar tissue cannot be discerned
Solution Approach 1:
The patent employs three-dimensional anatomical maps that incorporate additional information dimensions beyond what conventional 2D fluoroscopy provides. These 3D maps can integrate imaging data from CT or MRI scans, allowing visualization of tissue characteristics such as scar tissue density and composition. This enables clinicians to identify and avoid undesirable implant locations that would be invisible on standard fluoroscopic images.
Solution Approach 2:
The system changes the parameters used to characterize tissue by integrating multiple imaging modalities (CT, MRI) that provide different tissue contrast mechanisms. These imaging techniques reveal tissue properties such as density, composition, and structural integrity, allowing differentiation between healthy tissue and scar tissue. This parameter enrichment enables reliable identification of suitable versus unsuitable implant locations.
3Reliability
If multiple candidate locations are tested, then optimal lead placement can be found, but the process becomes time-consuming and inefficient
Solution Approach 1:
The system performs preliminary visualization of all candidate locations on the 3D anatomical map before actual testing begins. By displaying multiple candidate locations and their characteristics in advance, the clinician can pre-select the most promising locations based on anatomical suitability. This preliminary assessment reduces the number of locations that require actual electrical testing, thereby reducing overall procedure time while still ensuring optimal lead placement.
Solution Approach 2:
The system creates a virtual copy of the anatomical space through 3D mapping that allows virtual testing and visualization of multiple candidate locations. This virtual model serves as a surrogate for physical testing, enabling the clinician to evaluate and compare multiple locations mentally or through simulation before committing to actual lead placement. This reduces the number of physical testing iterations needed while maintaining confidence in selecting the optimal location.
Data Source
AI summary
Patient tissues are imaged using, e.g., a real-time fluoroscopic imaging system, along with a lead system being implanted. Parameters representative of lead placement efficacy—such as capture thresholds, phrenic nerve stimulation thresholds, impedance values or screw-in tip mechanical resistance values—are measured at candidate implant locations. Localization parameters identifying the candidate implant locations are also measured. In one example, a display is generated substantially in real-time showing: images of the tissues of the patient and the lead system being implanted; candidate locations of the electrodes; and parameters representative of lead placement efficacy at the candidate locations. In this manner, the implanting clinician can readily view capture thresholds and other helpful parameters at various candidate locations along with actual real-time images of the tissues of the patient and the lead system being implanted. Recorded images can also be displayed and, in some examples, multiple images can be superimposed over one another.