Nerve mapping system

• US 10,376,208 B2
• Filed: 10/05/2016
• Issued: 08/13/2019
• Est. Priority Date: 09/20/2013
• Status: Active Grant

• Current Assignee: Innovative Surgical Solutions, LLC (Johnson & Johnson)
• Original Assignee: Innovative Surgical Solutions, LLC (Johnson & Johnson)
• Inventors: Wybo, Christopher
• Primary Examiner(s): McCrosky, David J.
• Application Number:
  US15/286,323
• Publication Number:
  US 20170020450A1
• Time in Patent Office: 1,042 Days
• CPC Class Codes: A61B 2034/105 Modelling of the patient, e.g. for ligaments or bones
• CPC Class Codes: A61B 2505/05 Surgical care
• CPC Class Codes: A61B 34/10 Computer-aided planning, simulation or modelling of surgical operations
• CPC Class Codes: A61B 5/1104 induced by stimuli or drugs; A61B5/1102 takes precedence; investigating medicinal preparations G01N33/15
• CPC Class Codes: A61B 5/1107 Measuring contraction of parts of the body, e.g. organ, muscle apparatus for measuring work or force in general G01L
• CPC Class Codes: A61B 5/4029 for evaluating the peripheral nervous systems A61B5/24 takes precedence
• CPC Class Codes: A61B 5/4893 Nerves
• CPC Class Codes: A61B 5/6848 Needles
• CPC Class Codes: A61B 5/746 Alarms related to a physiological condition, e.g. details of setting alarm thresholds or avoiding false alarms alarms per se G08B
• CPC Class Codes: G06F 30/20 Design optimisation, verification or simulation optimisation, verification or simulation of circuit designs G06F30/30

Abstract

A nerve mapping system includes a plurality of electrodes, a sensor, and a processor in communication with each of the plurality of electrodes and the sensor. Each electrode is disposed on the distal end portion of one or more elongate medical devices configured to extend within an intracorporeal treatment area of a subject. The sensor is in communication with a muscle of a subject, and is configured to provide an output signal corresponding to a monitored response of the muscle. The processor receives an indication of the location of each electrode and an indication of a magnitude of the monitored muscular response. Using these parameters, the processor determines a distance to the nerve from the location of each of the plurality of electrodes, and constructs a virtual model of the nerve using the determined distance to the nerve at each of the plurality of locations.

Claims

1. A nerve mapping system comprising:

an elongate medical device having a cylindrical shape and configured to explore an intracorporeal treatment area of a subject, wherein the elongate medical device includes;

a distal end portion tapering to a tip;

a central axis intersecting the tip and extending through a center of the elongate medical device;

a first electrode disposed in a first location at the tip and on the central axis; and

at least one second electrode spaced apart from the first electrode and radially offset from the central axis in a second location;

a non-invasive mechanical sensor configured to provide a mechanomyography output signal corresponding to a monitored mechanical response of a muscle innervated by the nerve; and

a processor in communication with the first electrode, the at least one second electrode, and the non-invasive mechanical sensor, wherein the processor is configured to;

while the elongate medical device explores the intracorporeal treatment area, receive an indication of the first location of and the second location within the intracorporeal treatment area;

provide an electrical stimulus to the first electrode and the at least one second electrode such that the electrical stimulus may be transmitted to intracorporeal tissue at the first location and the second location;

receive an indication of a magnitude of the monitored mechanical response of the muscle from the mechanomyography output signal, wherein the monitored mechanical response of the muscle is induced by the electrical stimulus;

determine a distance to a nerve from the first location and the second location using a) a magnitude of the electrical stimulus and b) the monitored mechanical response of the muscle to the electrical stimulus without using an electromyography signal corresponding to an electrical potential of the muscle and skin of the subject; and

construct a virtual three-dimensional model of the nerve using the determined distance to the nerve at the first location and the second location to thereby precisely guide the elongate medical device within the intracorporeal treatment area without contacting the nerve.

2. The system of claim 1, wherein the processor is configured to determine the distance to the nerve by:

determining a minimum magnitude of the electrical stimulus that is needed to induce the monitored mechanical response of the muscle; and

determining the distance to the nerve from the determined minimum magnitude.

3. The system of claim 1, wherein the processor is further configured to:

merge the virtual three-dimensional model of the nerve with an anatomical imagery representative of the intracorporeal treatment area to form a merged nerve model; and

display the merged nerve model on a display.

4. The system of claim 3, wherein the anatomical imagery includes a 3D anatomical model.

5. The system of claim 3, wherein the anatomical imagery includes a real time 2D image.

6. The system of claim 1, further comprising a robotic controller operative to control a motion of an end effector disposed within the intracorporeal treatment area;

wherein the processor is further configured to provide the virtual three-dimensional model of the nerve to the robotic controller; and

wherein the robotic controller is configured to constrain the motion of the end effector using the virtual three-dimensional model.

7. The system of claim 1, wherein the processor is configured to construct the virtual three-dimensional model of the nerve by triangulating a location of the nerve using the indication of the first location and the second location and the determined distance to the nerve from the first electrode and the at least one second electrode.

8. The system of claim 1, wherein the processor is configured to construct the virtual three-dimensional model of the nerve by triangulating a location of the nerve in real-time, and wherein triangulating the location of the nerve includes:

registering the first location and the second location within a corresponding virtual workspace using the indication of the first location and the second location within the intracorporeal treatment area;

creating a 3D shell around the first location and the second location within the virtual workspace at a distance that is equal to the determined distance to the nerve from the first electrode and the at least one second electrode; and

filtering the virtual workspace to identify at least one area that has a shell-density greater than a predetermined threshold.

9. The system of claim 1, wherein the virtual three-dimensional model is constructed by the processor within a virtual workspace;

and

wherein the processor is further configured to identify a portion of the virtual workspace as not containing the nerve if the magnitude of the monitored mechanical response of the muscle is less than a threshold magnitude.

10. The system of claim 9, wherein the processor is further configured to identify a portion of the virtual workspace having a distance that is less than the determined distance to the nerve from the first electrode and the at least one second electrode as not containing the nerve.

11. The system of claim 1, wherein the processor is further configured to:

provide a first electrical stimulus at the first location within the intracorporeal treatment area, wherein the first electrical stimulus has a first current magnitude that does not induce a threshold mechanical response of a muscle innervated by the nerve;

provide a second electrical stimulus at the second location within the intracorporeal treatment area, wherein the second electrical stimulus has the first current magnitude and induces a monitored mechanical response of the muscle that is greater than the threshold mechanical response;

provide one or more additional electrical stimuli at the second location, wherein the one or more additional electrical stimuli has a current magnitude that is less than the first current magnitude;

determine, from the one or more additional electrical stimuli, a minimum current magnitude required to induce the threshold mechanical response of the muscle at the second location; and

wherein the processor is configured to determine the distance to the nerve from the second location using the determined minimum current magnitude.

12. The system of claim 11, wherein the virtual three-dimensional model of the nerve is located within a virtual workspace;

and

wherein the processor is further configured to;

register each of the first location and the second location within the virtual workspace;

indicate a portion of the virtual workspace surrounding the first location as not containing the nerve; and

construct the virtual three-dimensional model of the nerve within the workspace at the determined distance to the nerve from the second location.

13. The system of claim 1, wherein the processor is further configured to:

receive an indication of an anatomical target within the intracorporeal treatment area; and

determine an approach path to the anatomical target using the virtual three-dimensional model of the nerve, wherein the approach path minimizes a potential for contact with the nerve.

14. A nerve mapping system comprising:

an elongate medical device having a cylindrical shape and configured to explore an intracorporeal treatment area of a subject, wherein the elongate medical device includes;

a distal end portion tapering to a tip;

a central axis intersecting the tip and extending through a center of the elongate medical device;

a first electrode disposed in a first location at the tip and on the central axis; and

at least one second electrode spaced apart from the first electrode and radially offset from the central axis in a second location;

a non-invasive mechanical sensor configured to provide a mechanomyography output signal corresponding to a monitored mechanical response of a muscle innervated by a nerve disposed within the intracorporeal treatment area; and

a processor in communication with the first electrode, the at least one second electrode, and the non-invasive mechanical sensor, wherein the processor is configured to;

while the elongate medical device explores the intracorporeal treatment area, provide an electrical stimulus to the first electrode and the at least one second electrode such that the electrical stimulus may be transmitted to intracorporeal tissue at the first location and the second location within the intracorporeal treatment area, wherein the electrical stimulus has a current magnitude;

receive the mechanomyography output signal from the non-invasive mechanical sensor, wherein the mechanomyography output signal provides an indication of the monitored mechanical response of the muscle to the electrical stimulus at the first location and the second location; and

construct a virtual three-dimensional model of the intracorporeal treatment area from a) the current magnitude of the electrical stimulus at the first location and the second location and from b) the mechanomyography output signal without using an electromyography signal corresponding to an electrical potential of the muscle and skin of the subject to thereby precisely guide the elongate medical device within the intracorporeal treatment area without contacting the nerve, wherein the virtual three-dimensional model includes;

a first portion that is representative of the nerve; and

a second portion that is representative of a space within the intracorporeal treatment area that does not contain the nerve.

15. The system of claim 14, wherein the processor is further configured to:

receive an indication of an anatomical target within the intracorporeal treatment area; and

determine an approach path to the anatomical target using the virtual three-dimensional model that only extends through the second portion.

16. The system of claim 15, further comprising a robotic controller configured to constrain a motion of a tool extending within the intracorporeal treatment area relative to the determined approach path.

17. The system of claim 15, wherein the processor is further configured to merge an anatomical model with the virtual three-dimensional model;

wherein the anatomical model has an obstructing portion that includes at least a portion of a bone, intestine, liver, or kidney, and a non-obstructing portion that does not contain any of the bone, intestine, liver, or kidney; and

wherein the approach path extends only through the non-obstructing portion.

18. The system of claim 15, wherein the approach path is non-linear.

19. The system of claim 15, wherein the processor is further configured to:

monitor a location of a tool relative to the determined approach path;

display a first indicator if the tool is within a predefined tolerance of the approach path; and

display a second indicator if the tool is greater than the predefined tolerance from the approach path.