System and method of establishing a protocol for providing electrical stimulation with a stimulation system to treat a patient
View Patent ↗A stimulation system, such as a spinal cord stimulation (SCS) system, having a programmer and a patient feedback device for establishing a protocol to treat a patient. The programmer uses a computer assisted stimulation programming procedure for establishing the protocol. Also described are methods of treating a patient with a spinal cord stimulation system including the programmer and the patient feedback device.
1. A programming device for establishing a protocol for a plurality of electrodes in one or more medical leads coupled to an electrical stimulation generator, the programming device adapted to be in communication with the electrical stimulation generator and a patient feedback device, the programming device comprising:
a handheld housing;
a first communication portion, including a first antenna supported by the handheld housing, for wirelessly communicating with the electrical stimulation generator;
a second communication portion, including a second antenna supported by the handheld housing, for wirelessly communicating with the patient feedback device;
a user interface including a touch screen supported by the handheld housing and for implementing a graphical user interface; and
a controller supported by the handheld housing and coupled to the first communication portion, the second communication portion, and the user interface, the controller configured to create the protocol for providing electrical stimulation to treat the patient, wherein the controller is further configured to
initiate an automated and systematic sweeping of the plurality of electrodes with respective electrical stimulus from the electrical stimulation generator, including initiating a respective electrical stimulus with each electrode in a systematic sequence,
receive from the patient feedback device whether the patient provided first feedback while performing the automated and systematic sweeping,
pause the automated and systematic sweeping of the plurality of electrodes with the respective electrical stimulus in the systematic sequence,
re-initiate automated and systematic sweeping of the plurality of electrodes by being configured to initiate a second respective electrical stimulus with the plurality of electrodes in a reverse systematic sequence from the systematic sequence, the re-initiated automated and systematic sweeping in the reverse systematic sequence being in response to the receiving from the patient feedback device whether the patient provided the first feedback,
receive from the patient feedback device whether the patient provided second feedback while performing the re-initiated automated and systematic sweeping in the reverse systematic sequence, and
communicate the protocol to the electrical stimulation generator;
wherein the creating the protocol is based on the sweeping of the plurality of electrodes and the patient provided feedback.
2. The programming device of claim 1 , and further comprising a camera supported by the handheld housing, wherein the controller is coupled to the camera to receive images taken by the camera.
3. The programming device of claim 1 , wherein the automated and systematic sweeping is configured to initiate the respective electrical stimulus for a time period with each electrode in a systematic sequence, wherein the controller is further configured to determine when each respective electrical stimulus is generated, and associate the patient provided feedback with the respective electrical stimulus.
4. The programming device of claim 1 , wherein the initiating the automated and systematic sweeping is configured to initiate an automated and systematic sweep through the plurality of electrodes to determine a respective perception threshold associated with each electrode.
5. The programming device of claim 1 , wherein the initiating the automated and systematic sweeping is configured to initiate an automated and systematic sweep through the plurality of electrodes to determine an electrode that is associated with a pain area.
6. The programming device of claim 1 , wherein the initiating the automated and systematic sweeping is configured to initiate a first automated and systematic sweep through the plurality of electrodes to determine a respective perception threshold associated with each electrode, and initiating a second automated and systematic sweep through the plurality of electrodes to determine an electrode that is associated with a pain area.
7. The programming device of claim 6 , wherein the second automated and systematic sweep is performed using the respective perception thresholds from the first automated and systematic sweep.
8. The programming device of claim 6 , wherein the initiating the automated and systematic sweeping further includes initiating a third automated and systematic sweep through the plurality of electrodes to determine a respective impedance associated with each electrode.
9. The programming device of claim 1 , wherein the creating the protocol includes adjusting at least one of amplitude, frequency, pulse width, pulse shape, and stimulation type of an electrical stimulus to refine the protocol.
10. The programming device of claim 1 , wherein the creating the protocol further includes modifying an enablement or disablement of one of the plurality of electrodes to refine the protocol.
11. The programming device of claim 1 , and further comprising a third communication portion supported by the handheld housing and for communicating a video signal to an external display remote from the programming device, wherein the controller is coupled to the third communication portion.
12. A method for establishing a protocol for a plurality of electrodes in one or more medical leads coupled to an electrical stimulation generator, the programming device adapted to be in communication with the electrical stimulation generator and a patient feedback device, the method comprising:
creating a protocol for providing electrical stimulation to treat a patient by:
initiating an automated and systematic sweeping of the plurality of electrodes with respective electrical stimulus from the electrical stimulation generator, including initiating a respective electrical stimulus with each electrode in a systematic sequence;
receiving from the patient feedback device whether the patient provided first feedback while performing the automated and systematic sweeping;
pausing the automated and systematic sweeping of the plurality of electrodes with the respective electrical stimulus in the systematic sequence;
re-initiating automated and systematic sweeping of the plurality of electrodes by initiating a second respective electrical stimulus with the plurality of electrodes in a reverse systematic sequence from the systematic sequence, the re-initiated automated and systematic sweeping in the reverse systematic sequence being performed in response to the receiving from the patient feedback device whether the patient provided the first feedback;
receiving from the patient feedback device whether the patient provided second feedback while performing the re-initiated automated and systematic sweeping in the reverse systematic sequence; and
communicating the protocol to the electrical stimulation generator;
wherein the creating the protocol is based on the sweeping of the plurality of electrodes and the patient provided feedback.
13. The method of claim 12 , wherein the creating of the protocol further comprises determining when each respective electrical stimulus is generated, and associating the patient provided feedback with the respective electrical stimulus.
14. The method of claim 12 , wherein the initiating the automated and systematic sweeping comprises initiating an automated and systematic sweep through the plurality of electrodes to:
determine a respective perception threshold associated with each electrode; and
determine an electrode that is associated with a pain area.
15. The method of claim 12 , wherein the initiating the automated and systematic sweeping comprises:
initiating a first automated and systematic sweep through the plurality of electrodes to determine a respective perception threshold associated with each electrode;
initiating a second automated and systematic sweep through the plurality of electrodes to determine an electrode that is associated with a pain area, the second automated and systematic sweep using the respective perception thresholds from the first automated and systematic sweep; and
initiating a third automated and systematic sweep through the plurality of electrodes to determine a respective impedance associated with each electrode.
16. The method of claim 12 , wherein the creating the protocol further includes:
adjusting at least one of amplitude, frequency, pulse width, pulse shape, and stimulation type of an electrical stimulus to refine the protocol; and
modifying an enablement or disablement of one of the plurality of electrodes to refine the protocol.
17. The method of claim 12 , further comprising communicating a video signal to an external display remote from the programming device.
18. A medical system, comprising:
one or more medical leads each containing a plurality of electrodes;
an electrical stimulation generator configured to be coupled to the one or more medical leads to deliver electrical stimulation to a patient;
a patient feedback device; and
a programming device configured to be communicatively coupled to the electrical stimulation generator, wherein the programming device includes:
a handheld housing;
a first communication portion, including a first antenna supported by the handheld housing, for wirelessly communicating with the electrical stimulation generator;
a second communication portion, including a second antenna supported by the handheld housing, for wirelessly communicating with the patient feedback device;
a user interface including a touch screen supported by the handheld housing and for implementing a graphical user interface; and
a controller supported by the handheld housing and coupled to the first communication portion, the second communication portion, and the user interface, the controller configured to create the protocol for providing electrical stimulation to treat the patient, wherein the controller is further configured to perform the following:
initiating an automated and systematic sweeping of the plurality of electrodes with respective electrical stimulus from the electrical stimulation generator, including initiating a respective electrical stimulus with each electrode in a systematic sequence;
receiving from the patient feedback device whether the patient provided first feedback while performing the automated and systematic sweeping;
pausing the automated and systematic sweeping of the plurality of electrodes with the respective electrical stimulus in the systematic sequence;
re-initiating automated and systematic sweeping of the plurality of electrodes by being configured to initiate a second respective electrical stimulus with the plurality of electrodes in a reverse systematic sequence from the systematic sequence, the re-initiated automated and systematic sweeping in the reverse systematic sequence being in response to the receiving from the patient feedback device whether the patient provided the first feedback;
receiving from the patient feedback device whether the patient provided second feedback while performing the re-initiated automated and systematic sweeping in the reverse systematic sequence; and
communicating the protocol to the electrical stimulation generator;
wherein the creating the protocol is based on the sweeping of the plurality of electrodes and the patient provided feedback.
19. The system of claim 18 , wherein the initiating the automated and systematic sweeping comprises initiating an automated and systematic sweep through the plurality of electrodes to:
determine a respective perception threshold associated with each electrode; and
determine an electrode that is associated with a pain area.
20. The system of claim 18 , wherein the initiating the automated and systematic sweeping comprises:
initiating a first automated and systematic sweep through the plurality of electrodes to determine a respective perception threshold associated with each electrode;
initiating a second automated and systematic sweep through the plurality of electrodes to determine an electrode that is associated with a pain area, the second automated and systematic sweep using the respective perception thresholds from the first automated and systematic sweep; and
initiating a third automated and systematic sweep through the plurality of electrodes to determine a respective impedance associated with each electrode.