Wireless implantable device position validation in situ
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.
1. A method of validating a position of a wirelessly powered electrostimulation device while the device is implanted in body tissue, the method comprising:
situating, using a catheter and a push rod configured to travel inside the catheter, the electrostimulation device in tissue;
pulling the push rod away from the electrostimulation device while electrodes of the device are in contact with the tissue; and
before an affixation mechanism of the electrostimulation device is deployed to maintain an implanted position of the electrostimulation device, 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.
2. The method of claim 1 , wherein performing electrical testing of the electrostimulation device occurs while:
the affixation mechanism of the device is situated in the catheter, and
the catheter is at least partially inside the tissue.
3. The method of claim 1 , wherein the catheter comprises a radio transparent material.
4. The method of claim 1 , wherein situating the electrostimulation device in the tissue includes translating the device axially inside the catheter while the catheter is partially in the tissue so the electrodes extend out of the catheter into the tissue and the affixation mechanism remains in the catheter.
5. The method of claim 1 , wherein the catheter comprises a radio transparent material and the method further comprises 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 of the push rod and mechanically connected to a proximal portion of the electrostimulation device.
6. The method of claim 5 , wherein maintaining the suture in the lumen includes wrapping a proximal portion of the suture around a thread of the push rod and securing the thread.
7. The method of claim 6 , wherein securing the thread further includes tightening a luer cap around the thread of the push rod.
8. The method of claim 7 , wherein:
the thread is one of a plurality of threads;
the wrapping is a first wrapping of a first portion of the suture around a first thread of the plurality of threads; and
the method further comprises further wrapping a second, different portion of the suture around a second thread of the plurality of threads, such that loosening the cap releases the first portion during the loosening while retaining the second portion.
9. The method of claim 5 , wherein maintaining the suture in the lumen includes situating a retention mechanism on the suture at a location more proximal than the lumen, the retention mechanism configured such that it cannot travel through the lumen.
10. The method of claim 1 , wherein performing the electrical testing includes, performing operations by an external device in wireless communication with the electrostimulation device, the operations comprising:
providing a first configuration signal to the electrostimulation device to cause the electrostimulation device to configure a particular first one of its multiple electrodes as an anode electrode and a particular second one of its multiple electrodes as a cathode electrode;
providing one or more first operation signals to the electrostimulation device to cause the electrostimulation device to provide a first electrostimulation output at a specified first voltage or current level;
in response to a determination that the first electrostimulation output did not evoke a response from the patient, providing one or more second operation signals to the electrostimulation device to cause the electrostimulation device to provide a second electrostimulation output at a specified second voltage or current level that is greater than the first voltage or current level;
in response to a determination that the first or the second electrostimulation output did evoke a response from the patient, providing one or more signals to the electrostimulation device that cause the electrode configuration to change and the electrode configuration to be recorded, at the external device, along with the voltage or current that caused the response; and
providing one or more signals to the electrostimulation device that cause the electrostimulation device to produce third electrostimulation at a voltage or current for which the electrostimulation evoked a response.
11. The method of claim 10 , wherein the operations further comprise, in response to a determination that voltage or current is at or above a specified threshold, providing one or more signals to the electrostimulation device that cause the electrode configuration to change.
12. The method of claim 10 , wherein the determination of whether the electrostimulation produced a response includes receiving data from an electromyography sensor situated on the patient indicating the response was detected.
13. The method of claim 10 , wherein the determination of whether the electrostimulation produced a response includes receiving data from an accelerometer situated on the patient indicating the response was detected.
14. The method of claim 10 , wherein the operations further comprise alerting an operator to adjust a position of the electrostimulation device within the patient when the first or second voltage or current level meets or exceeds a specified threshold level.
15. The method of claim 14 , wherein alerting the operator to adjust the position of the electrostimulation device includes providing instructions to re-position the electrostimulation device without requiring removal of the electrostimulation device from a deployment catheter.