Medical Probe Coils and Electrodes for Precise Vein of Marshall Navigation
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Solution Overview
Problem
Current ablation technologies for treating cardiac arrhythmias, such as paroxysmal atrial fibrillation, face challenges in accessing regions like the ligament of Marshall due to tortuous anatomical paths, and existing methods like RF ablation and cryoablation have risks or are difficult to maneuver, while irreversible electroporation (IRE) requires precise navigation.
Innovation Solution
A medical probe with an elongated shaft, guidewire, and coils and electrodes that can generate currents in a magnetic field for position sensing and ablation, allowing precise navigation and energy delivery to target tissues.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Ease of operation
If conventional catheters are used to access the ligament of Marshall, then the procedure is simpler, but the catheter cannot traverse the tortuous anatomical path comprising acute angular bends
Solution Approach 1:
The catheter is divided into multiple segments or sections that can independently bend and articulate. This segmentation allows the catheter to navigate acute angular bends and tortuous paths by flexing at the joints between segments, enabling access to the ligament of Marshall region that would be unreachable by conventional straight catheters.
Solution Approach 2:
The catheter incorporates curved or articulated sections with variable rigidity that can adapt to the tortuous anatomy. The curved design allows the catheter to follow the natural bends and angles of the coronary sinus and vein of Marshall, enabling navigation through acute angular bends while maintaining structural integrity.
2Reliability
If RF ablation is used to treat cardiac arrhythmias, then the ablation procedure is effective, but thermal risks such as tissue charring, burning, and phrenic nerve palsy occur
Solution Approach 1:
The system transitions from thermal-based RF ablation to non-thermal IRE by changing the physical parameters of energy delivery. Instead of continuous thermal energy, IRE uses short-duration high-voltage electric pulses that create irreversible electroporation of cell membranes, achieving reliable ablation of the ligament of Marshall without thermal conduction to surrounding sensitive structures.
Solution Approach 2:
The ablation mechanism transitions from thermal phase (RF heating) to electrical phase (IRE). The IRE process uses high-voltage electric fields to induce a phase change in cell membranes from intact to permeabilized state, creating permanent pores that lead to cell death without requiring thermal energy, thereby eliminating thermal damage risks.
3Object-affected harmful factors
If cryoablation is used instead of RF ablation, then thermal risks are reduced, but the device is more difficult to maneuver and not viable in certain anatomical geometries
Solution Approach 1:
The system adopts IRE with non-thermal electric field delivery, changing the energy modality from thermal (cryoablation) to electrical. This allows the use of a more maneuverable catheter design with flexible shaft and articulated sections that can navigate tortuous paths, while maintaining the non-thermal advantage of reduced thermal damage through electroporation-based ablation.
4Object-affected harmful factors
If IRE is delivered using multi-electrode probes, then nonthermal ablation is achieved, but precise navigation to the target region is required in difficult-to-access areas
Solution Approach 1:
The catheter incorporates position sensing capability with real-time feedback of the catheter tip location within the coronary sinus and vein of Marshall. This feedback system, combined with navigation software, provides continuous monitoring of catheter position and orientation, enabling precise positioning of the multi-electrode array at the ligament of Marshall target site despite the tortuous anatomical path.
Solution Approach 2:
The catheter integrates multiple functions into a single device: navigation through tortuous paths using articulated sections, position sensing and tracking, delivery of IRE energy through multiple electrodes, and potentially ablation monitoring. This multi-functional design enables precise navigation and accurate positioning of the IRE electrodes at the difficult-to-access ligament of Marshall region.
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
Enables effective and precise ablation of cardiac tissues in challenging anatomical regions like the ligament of Marshall, reducing thermal risks and improving the efficacy of IRE by enhancing navigation and energy delivery.
Implementation Method 1
The coils are connected to the distal tip along the longitudinal axis, with each coil being configured to generate a current when subjected to a magnetic field. The current is indicative of a position of the respective coil.
Implementation Method 2
each electrode being configured to (i) sense anatomical signals in the vein of Marshall and provide electrical signals which are indicative of the anatomical signals or (ii) convey ablation energy to a target tissue region proximal the vein of Marshall
Data Source
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AI summary
The disclosed technology includes medical probe that includes an elongated shaft, a guidewire, coils, and electrodes. The elongated shaft extends along a longitudinal axis and is dimensioned to be inserted into a vein of Marshall. The guidewire extends through a lumen in the elongated shaft. The coils are connected to the distal dip of the elongated shaft and each coil is configured to generate a current when subjected to a magnetic field, the current being indicative of a position of the respective coil. The electrodes are connected to the distal tip. Each electrode is designed to (i) sense anatomical signals in the vein of Marshall and provide electrical signals which are indicative of the anatomical signals or (ii) convey ablation energy to a target tissue region proximal the vein of Marshall.