Wireless implantable device position validation in situ
Inventors
Yeh, Alexander • Fayram, Timothy A. • Holinski, Brad • Ellsworth, III, Thomas Burpee • Sabesan, Shivkumar • Schellenberg, Stephen James • Morris, Milton M. • Junco, Elia
Assignees
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Publication Number
US-12220589-B2
Publication Date
2025-02-11
Expiration Date
Abstract
Systems, devices, and methods discussed herein can be for validating a position of a wirelessly powered electrostimulation device while the device is implanted in body tissue. A method can include situating the electrostimulation device in tissue and before an affixation mechanism of the electrostimulation device is deployed to maintain an implanted position of the electrostimulation device, and while electrodes of the device are in contact with the tissue, performing electrical testing of the electrostimulation device to determine whether the electrostimulation from the electrostimulation device evokes a specified response from the body that contains the tissue.
Core Innovation
The disclosure provides a method of validating a position of a wirelessly powered electrostimulation device while the device is implanted in body tissue. The method situates the electrostimulation device in tissue using a catheter and a push rod configured to travel inside the catheter, then pulls the push rod away from the electrostimulation device while electrodes of the device remain in contact with the tissue.
After pulling the push rod away, and while the electrodes remain in contact with the tissue, the method performs electrical testing to determine whether the electrostimulation from the electrostimulation device evokes a specified response from the body containing the tissue. The method performs this electrical testing before an affixation mechanism is deployed to maintain an implanted position of the electrostimulation device.
The disclosure also describes wireless external control to set or change an electrode configuration, including an anode electrode and a cathode electrode configuration, and to perform electrical testing while evaluating a specified patient response. EMG sensor data and/or accelerometer sensor data are used to detect whether the specified response is evoked, and the testing results may be recorded and used to alert an operator to adjust device position without removing the device from the catheter.
Claims Coverage
Independent claim clm-00001 recites a validation workflow with three main inventive features. Dependent claims refine the workflow by adding wireless control of electrode anode/cathode configuration, escalated test outputs until a specified patient response is detected, threshold-based changes, EMG response detection, and radio-transparent catheter materials and push-rod/suture mechanics.
Catheter-based situating of a wirelessly powered electrostimulation device
Situating, using a catheter and a push rod configured to travel inside the catheter, the electrostimulation device in tissue.
Push-rod retraction while maintaining electrode-tissue contact
Pulling the push rod away from the electrostimulation device while electrodes of the device are in contact with the tissue.
Pre-affixation electrical testing to evoke a specified body response
Before an affixation mechanism of the electrostimulation device is deployed to maintain an implanted position of the electrostimulation device, and after pulling the push rod away from the electrostimulation device, and while electrodes of the device are in contact with the tissue, performing electrical testing of the electrostimulation device to determine whether the electrostimulation from the electrostimulation device evokes a specified response from the body that contains the tissue.
Wireless external control of electrode anode/cathode configuration during testing with escalated outputs
Using wireless communication to configure electrode anode/cathode configuration and performing electrical testing by applying first electrostimulation at a specified first voltage or current level, determining whether it evokes a response, and if no response is detected, applying second electrostimulation output at a specified second voltage or current level and changing and recording electrode configuration associated with producing electrostimulation that evokes the response.
Threshold-triggered electrode configuration change
In response to a determination that voltage or current is at or above a specified threshold, providing signals to change electrode configuration.
Response detection using an electromyography (EMG) sensor on the patient
Determining whether electrostimulation produced a response by receiving data from an electromyography sensor situated on the patient indicating the response was detected.
Radio-transparent catheter material for testing during electrode contact
Specifying that the catheter includes a radio transparent material.
Suture maintained in the push rod lumen to mechanically connect to the device during push-rod withdrawal
Using a catheter with a radio transparent material and pulling the push rod away from the electrostimulation device while maintaining a suture in a lumen of the push rod, the suture extending through the lumen and mechanically connected to a proximal portion of the electrostimulation device.
Across the independent claim and refined dependents, the claims cover validating an implanted, wirelessly powered electrostimulation device position by catheter-based placement, retracting the push rod while maintaining tissue-contacting electrodes, and performing electrical testing before affixation to confirm that stimulation evokes a specified body response. Dependent claim features further cover wireless external control of electrode configuration with escalating electrical testing, threshold-based configuration change, EMG-based response detection, and additional catheter and push-rod/suture mechanical properties including radio-transparent materials.
Stated Advantages
Shorter procedures.
Fewer revisions.
Reduced infection risk.
Validating whether stimulation evokes a specified response from the body before an affixation mechanism is deployed to maintain the implanted position.
Documented Applications
DRG/ventral root stimulation.
Brain stimulation, including deep brain stimulation.
Intravascular ultrasound neuromodulation systems.
Validating the position of a wirelessly powered electrostimulation device while the device is implanted in body tissue using catheter placement, push-rod retraction, electrical testing, and subsequent deployment of an affixation mechanism.
Catheter/push-rod and suture retention related to implant verification via electrical testing while electrodes remain in tissue contact.
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