Robotic navigation and guidance system for implanting a neuromodulation device
The present invention provides a robotic navigation system for identifying a target nerve for guiding and/or performing the implanting a neuromodulation device at the target nerve wherein the neuromodulation device includes a pulse generator and at least one lead in electrical or operative connection with the pulse generator. In some embodiments, the location of the robotically advanced lead and electrode may be imaged and displayed on a display and/or may be visually annunciated using one or more lights to indicate whether the placement location of the lead or electrode is within or outside of a predetermined distance of the target nerve.
1 . A robotic navigation system for identifying a target nerve within a surgical site for implanting a neuromodulation device comprising at one or more leads within the surgical site, comprising:
a robotic arm, the robotic arm comprising an effector end,
at least one recess defined by the neuromodulation device configured to allow the effector end to grip the neuromodulation device at the at least one recess;
a control system configured to receive three-dimensional preoperative data comprising a spatial location of bone structures of two adjacent vertebrae within the surgical site, the control system comprising a registration system configured to register a coordinate system of the robotic arm with the received three-dimensional preoperative data, wherein the robotic arm is in operative connection and communication with the control system;
a display screen in operative connection and communication with the control system and configured to display the spatial location of the bone structures; wherein the control system is configured to calculate an estimated target nerve location based upon the three-dimensional preoperative data,
wherein the control system is configured to display a virtual indicator of the calculated target nerve location on the display screen in the estimated target nerve location relative to the spatial location of the bone structures;
a visual indicator comprising at least one light annunciator configured for light-annunciated guidance of placement and position of each one of the one or more leads relative to the target nerve, wherein the at least one light annunciator comprises a color-coded annunciator comprising: a first color annunciating a position of each one of the one or more leads that is within a predetermined range of optimal placement and position relative to the target nerve, and a second color annunciating a position of each one of the one or more leads that is outside the predetermined range of optimal placement, wherein the visual indicator is in operative communication and connection with the robotic arm and the display screen;
a safety control system in operative connection and communication with the control system and configured to be controlled by the control system, wherein the safety control system and/or the control system is configured to control the robotic arm, wherein the robotic arm is configured to receive instructions from the control system based on a preoperative plan based on the three-dimensional preoperative data and the calculated estimated target nerve location,
wherein the control system is configured to position the robotic arm preoperatively according to the received instructions over a predetermined incision location with a predetermined angle of entry and a predetermined depth,
wherein the effector end of the robotic arm comprises an incision tool configured to make an incision at the predetermined incision location at the predetermined angle of entry and the predetermined incision depth according to the received instructions from the control system,
wherein the safety control system requires instructions requiring separate affirmative preoperative confirmation steps from a surgeon to confirm the preoperative position of the robotic arm prior to making the incision, the separate affirmative preoperative confirmation steps including (1) the preoperative position of the robotic arm regarding the predetermined location of the incision, (2) the predetermined angle of entry, and (3) the predetermined incision depth, and
wherein each one of the separate preoperative confirmation steps require separate actuation steps performed by the surgeon.
2 . The robotic navigation system in accordance with claim 1 , wherein the target nerve is a dorsal root ganglion.
3 . The robotic navigation system in accordance with claim 1 , wherein the target nerve is a spinal cord.
4 . The robotic navigation system of claim 1 , wherein the estimated target nerve location is based upon an MRI.
5 . The robotic navigation system of claim 1 , wherein the calculated estimated target nerve location is based upon an estimated anatomical distance from the bone structures.
6 . The robotic navigation system of claim 1 , wherein the calculated estimated target nerve location is based upon fiducial markers registered by the registration system.
7 . The robotic navigation system of claim 1 , wherein the estimated target nerve location is using machine learning, said machine learning providing said estimated target nerve location based upon an annotated training set of multiple bone structure images and target nerve locations.
8 . The robotic navigation system of claim 1 , wherein the estimated target nerve location is based upon an evoked response.