Depth Sensing Dilator With RF Impedance Feedback
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Solution Overview
Problem
Current transseptal crossing technologies lack an effective and precise method for accessing the left atrium, as existing needles and sheath systems do not provide reliable location confirmation and tissue penetration control, leading to potential complications during electrophysiology and structural heart procedures.
Innovation Solution
A transseptal crossing system comprising a flexible tubular needle with an electrically conductive sidewall, a distal electrode tip for RF energy delivery and impedance measurement, and a depth sensing dilator system with multiple electrodes for precise tissue penetration and location confirmation, enabling safe and controlled access to the left atrium.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Measurement precision
If a standard Brockenbrough needle is used for mechanical puncture, then tissue penetration can be achieved, but reliable location confirmation and penetration control are lacking
Solution Approach 1:
The patent combines multiple functions into a single integrated needle system: the needle includes both mechanical puncture capability and RF energy delivery capability, with electrodes integrated into the needle body. This merging allows location confirmation and penetration control through RF impedance measurements while maintaining the mechanical puncture function, eliminating the need for separate localization devices.
Solution Approach 2:
The patent implements feedback through RF impedance measurements taken during needle advancement. The system continuously monitors impedance changes as the needle penetrates tissue, providing real-time feedback about penetration depth and tissue characteristics. This feedback mechanism enables precise location confirmation and controlled penetration without requiring complex external imaging systems.
2Loss of information
If fluoroscopy and ultrasound are used to locate the fossa ovalis, then location information can be obtained, but the procedure becomes more complex and time-consuming
Solution Approach 1:
The needle system performs self-localization through RF impedance measurements without requiring external fluoroscopy or ultrasound equipment. The electrodes on the needle independently measure tissue impedance to determine location and penetration status, making the system self-sufficient for localization tasks and eliminating dependence on separate imaging systems.
Solution Approach 2:
The patent replaces mechanical/optical imaging systems (fluoroscopy, ultrasound) with an electrical field-based RF impedance measurement system. Instead of using external imaging devices to visualize anatomy, the system uses RF energy to electrically characterize tissue and determine needle location, substituting a simpler electrical measurement approach for complex imaging procedures.
3Measurement precision
If pressure sensing or contrast injection is used to confirm penetration, then penetration confirmation is possible, but the system lacks precise depth control
Solution Approach 1:
The patent measures changes in RF impedance as the needle penetrates tissue to determine penetration depth. By monitoring how impedance parameters change during advancement, the system can precisely measure depth and confirm penetration without requiring pressure sensors or contrast injection, using instead the natural electrical properties of tissue at different depths.
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
The system provides precise location confirmation and controlled tissue penetration, reducing procedural risks and improving the accuracy of accessing the left atrium during heart procedures by using RF energy and impedance measurements for real-time feedback.
Implementation Method 1
transmitting RF energy from a battery powered generator through the needle and to the fossa to penetrate the fossa and enter the left atrium
Implementation Method 2
A battery powered RF generator is configured to deliver RF energy to the electrode tip and also to measure impedance at the tip to provide information about the location of the electrode tip
Data Source
AI summary
A depth sensing dilator system for dilating a penetration in a tissue plane includes an elongate flexible body, having a proximal end and a distal end. The body has a tapered dilator segment, and at least a first electrode on a distal end of the body. The system includes a processor and a user interface output device. The processor is configured to send a first signal to the output device when a change in impedance at the first electrode indicates that the first electrode has reached a predetermined relationship with the tissue plane.