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Publication Number
US-12167894-B2
Publication Date
2024-12-17
Expiration Date
Abstract
An endovascular device monitoring system is provided that determines, based on movement of the endovascular device past a selected reference location, at least one of a movement rate of an endovascular device and position of a distal end of an endovascular device in a body of a patient.
Core Innovation
An endovascular laser catheter monitoring/control system includes a sheath and a laser catheter configured to move relative to the sheath. The laser catheter has a distal tip, and the sheath or the laser catheter includes a sensor configured to sense a position of the distal tip. A controller comprising non-transient, tangible computer readable medium logic monitors an output of the sensor to determine a rate of manual advancement or removal of the laser catheter by an operator and compares the determined rate of movement with at least one threshold movement rate.
When the determined rate of movement falls outside the at least one threshold movement rate, the controller operates based on a selection signal that places the controller into an assisted mode or an unassisted mode. In the assisted mode, the controller monitors an output of the sensor to determine a manual and unregulated rate of advancement or removal of the laser catheter, and when the manual and unregulated rate falls outside a threshold range, the controller automatically regulates the rate of advancement or removal.
In the unassisted mode, when the manual rate of advancement or removal falls outside a permissible threshold, the controller generates an operator alert without automatically regulating the rate of advancement or removal. The system further supports selecting and switching between assisted mode and unassisted mode, and in the assisted mode an operational parameter transitions automatically from unregulated to regulated when unacceptable catheter operation is detected, including an unacceptable movement rate of the distal tip based on comparison of a predetermined threshold to the determined laser catheter movement rate and/or distal tip position.
Claims Coverage
The document provides two independent claims that share a common core: a sheath and laser catheter with a distal-tip position sensor, plus controller logic that evaluates catheter movement against thresholds and then acts differently depending on an assisted-mode versus unassisted-mode selection. Across the independent claims, the inventive features emphasize sensor-based determination of distal tip movement/position and mode-dependent regulation versus alerting/feedback, including automatic transition from unregulated to regulated upon detection of unacceptable movement.
Sheath and distal-tip position sensing
A system comprising a sheath; a laser catheter configured to receive laser energy and configured to move relative to the sheath, the laser catheter comprising a distal tip; and the sheath or the laser catheter comprising a sensor configured to sense a position of the distal tip of the laser catheter.
Rate determination and threshold comparison with mode-dependent action
A controller comprising a non-transient, tangible computer readable medium including logic, whereupon execution of the logic, the controller is configured to monitor an output of the sensor to determine a rate of manual advancement or removal of the laser catheter by an operator, compare the determined rate with at least one threshold movement rate, and receive a selection signal configured to place the controller in an assisted mode or an unassisted mode.
Assisted mode automatic regulation; unassisted mode operator alert
When the selection signal places the controller in the assisted mode, the controller monitors an output of the sensor to determine a manual and unregulated rate of advancement or removal of the laser catheter and, in response to the rate falling outside a threshold range, automatically regulates the rate of advancement or removal. When the selection signal places the controller in the unassisted mode, the controller monitors an output of the sensor to determine a manual and unregulated rate of advancement or removal and, in response to the manual rate falling outside a permissible threshold, generates an operator alert without automatically regulating the rate of advancement or removal.
Assisted/unassisted mode switching and automatic transition on unacceptable operation
The controller is configured to selectively regulate an operational parameter of the laser catheter in the assisted mode, provide feedback to a user and not regulate the operational parameters in the unassisted mode, and switch between the assisted mode and the unassisted mode based on a user selection. In the assisted mode, the operational parameter transitions automatically from unregulated to regulated when unacceptable catheter operation is detected while the operational parameter is unregulated, the unacceptable catheter operation comprising an unacceptable movement rate of the distal tip based on comparison of a predetermined threshold to the determined laser catheter movement rate and/or distal tip position.
Across the independent claims, claim coverage centers on a distal-tip position sensor for a moving laser catheter relative to a sheath, controller logic that determines manual advancement/removal rate and compares it to threshold movement rates, and mode-dependent behavior driven by a selection signal. The claims define assisted mode as automatic/selective regulation, including automatic transition from unregulated to regulated upon detecting unacceptable catheter operation, and unassisted mode as feedback or operator alert without regulation.
Stated Advantages
Automatically regulating the rate of advancement or removal of the laser catheter when movement falls outside a threshold range (assisted mode).
Generating an operator alert without automatically regulating the rate of advancement or removal when movement falls outside a permissible threshold (unassisted mode).
Providing feedback to a user and not regulating operational parameters in the unassisted mode.
Documented Applications
Not explicitly described in patent.
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