Method and system for identifying a location for nerve stimulation

• US 9,888,864 B2
• Filed: 03/10/2011
• Issued: 02/13/2018
• Est. Priority Date: 03/12/2010
• Status: Active Grant

• Current Assignee: Inspire Medical Systems, Inc.
• Original Assignee: Inspire Medical Systems, Inc.
• Inventors: Rondoni, John, Christopherson, Mark A., Ni, Quan
• Primary Examiner(s): MCEVOY, THOMAS M
• Application Number:
  US13/634,333
• Publication Number:
  US 20130204097A1
• Time in Patent Office: 2,532 Days
• CPC Class Codes: A61B 2034/2065 Tracking using image or pattern recognition
• CPC Class Codes: A61B 2505/05 Surgical care
• CPC Class Codes: A61B 2562/043 in a linear array
• CPC Class Codes: A61B 34/20 Surgical navigation systems; Devices for tracking or guiding surgical instruments, e.g. for frameless stereotaxis
• CPC Class Codes: A61B 34/25 User interfaces for surgical systems
• CPC Class Codes: A61B 5/0536 Impedance imaging, e.g. by tomography
• CPC Class Codes: A61B 5/08 Detecting, measuring or recording devices for evaluating the respiratory organs A61B5/0205 takes precedence
• CPC Class Codes: A61B 5/1104 induced by stimuli or drugs; A61B5/1102 takes precedence; investigating medicinal preparations G01N33/15
• CPC Class Codes: A61B 5/24 Detecting, measuring or recording bioelectric or biomagnetic signals of the body or parts thereof
• CPC Class Codes: A61B 5/389 Electromyography [EMG]
• CPC Class Codes: A61B 5/4519 Muscles A61B5/389, A61B5/224 take precedence
• CPC Class Codes: A61B 5/4818 Sleep apnoea
• CPC Class Codes: A61B 5/4893 Nerves
• CPC Class Codes: A61B 5/6814 Head
• CPC Class Codes: A61B 5/682 Mouth, e.g., oral cavity; tongue; Lips; Teeth
• CPC Class Codes: A61B 5/6822 Neck
• CPC Class Codes: A61B 5/6839 Anchoring means, e.g. barbs
• CPC Class Codes: A61B 5/6843 Monitoring or controlling sensor contact pressure
• CPC Class Codes: A61B 5/6849 in combination with a needle set
• CPC Class Codes: A61B 5/7425 Displaying combinations of multiple images regardless of image source, e.g. displaying a reference anatomical image with a live image geometric transforms for image registration G06T3/14; enhancement using image fusion G06T5/50; algorithms for registration of images G06T7/30
• CPC Class Codes: A61B 5/7435 : Displaying user selection data, e.g. icons in a graphical user interface
• CPC Class Codes: A61N 1/372 : Arrangements in connection with the implantation of stimulators
• CPC Class Codes: A61N 1/37241 : providing test stimulations
• CPC Class Codes: A61N 1/37247 : User interfaces, e.g. input or presentation means

Abstract

A system and method for identifying a stimulation location on a nerve is disclosed. The system includes an image-based navigation interface used to facilitate advancing a stimulation element within a patient body toward a target nerve stimulation site. Using the system one determines, separately for each potential target nerve stimulation site, a neuromuscular response of muscles produced upon applying a stimulation signal at the respective separate potential target stimulation sites. The image-based navigation interface is configured to display a graphic identification of which muscles were activated for each respective potential target nerve stimulation site upon applying the stimulation signal.

Claims

1. A system for placing a stimulation element, the system comprising:

a neuromuscular response evaluation module including;

a stimulation engine to apply an electrical stimulation signal to at least one nerve within a patient head-and-neck portion via a stimulation element; and

a muscle response portion to determine, via at least sensing in association with at least one sensor probe, a response of at least one muscle in the patient head-and-neck portion to application of the stimulation signal;

a probe interface including an array of ports;

an array of sensor probes, including the at least one sensor probe with each sensor probe removably connectable to a respective one of the ports and removably couplable relative to at least one muscle in a patient head-and-neck portion, the sensor probe to at least partially implement the sensing of the response of the at least one muscle; and

a graphical user interface;

a controller including a processing unit; and

a non-transitory memory storing instructions, executable via the processing unit, to;

display, on the graphical user interface, at least one internal image of the patient head-and-neck portion; and

visually identify, superimposed on the at least one internal image on the graphical user interface, which muscles in the head-and-neck portion, including the at least one muscle, were activated for each respective application of the stimulation signal to at least one nerve in the head-and-neck portion.

2. The system of claim 1, wherein the muscle response portion comprises:

a stimulation path analyzer to differentiate between application of the electrical stimulation signal to the at least one nerve in the head-and-neck portion innervating the at least one muscle in the head-and-neck portion and direct application of the electrical stimulation signal to the at least one muscle,

wherein the stimulation path analyzer comprises at least one of;

an electromyography circuitry configured to determine the response of the at least one muscle in the head-and-neck portion via electromyography; and

a compound muscle action potential module configured to determine the response of the at least one muscle via observing a compound muscle action potential.

3. The system of claim 1, wherein the instructions comprise instructions to:

track and display, on the graphical user interface, a location of each sensor probe on the at least one internal image and to determine the location based on at least one of;

a visualization of the sensor probe captured during creation of the at least one internal image; and

a user-positionable, graphic marker superimposable on the at least one internal image on the graphical user interface, wherein a location of the graphic marker represents the location of a respective one of the sensor probes.

4. The system of claim 1, wherein at least some of the sensor probes include ultrasound detection nodes to detect muscle motion associated with the response of the at least muscle.

5. The system of claim 1, wherein at least one of the sensor probes includes at least one of:

a multi-balloon catheter to sense, via air pressure, a location of obstruction within an upper airway in the patient head-and-neck portion; and

an endoscopic imaging device to detect, in association with the response of the at least one muscle, at least one of a change in a cross-sectional area of an upper airway in the head-and-neck portion or a change in a cross-sectional shape of the upper airway in the patient head-and-neck portion.

6. The system of claim 1, wherein the instructions comprise instructions to:

graphically identify on the graphical user interface, via superimposition of a target nerve identifier on the at least one internal image of the head-and-neck portion, a location of the at least one nerve, wherein the at least one nerve includes a target nerve; and

graphically identify on the graphical user interface, via superimposition of a target muscle identifier on the at least one internal image of head-and-neck portion, a location of a target muscle innervated by the target nerve, wherein the target muscle includes the at least one muscle, the respective target nerve identifier and target muscle identifier to be user-positionable on the at least one internal image.

7. The system of claim 1, wherein the instructions comprise instructions to:

graphically identify, on the graphical user interface, an actually-stimulated nerve identifier on the at least one internal image a location of the at least one nerve actually stimulated via the applied stimulation signal; and

graphically identify, on the graphical user interface, an actually-activated muscle identifier on the at least one internal image a location of the at least one muscle actually activated via the actually stimulated nerve,

wherein the respective locations of the actually-stimulated nerve identifier and actually-stimulated muscle identifier are automatically highlighted on the at least one internal image on the graphical user interface upon sensing the muscle activation via a sensor probe coupled to the at least one muscle.

8. The system of claim 1, wherein the instructions comprise instructions to:

display on the graphical user interface, as part of a nerve muscle index, a first listing of potential target nerves, including the at least one nerve; and

display on the graphical user interface, as part of the nerve muscle index, a second listing of muscles, including the at least one muscle, wherein each listed muscle is correlated to one of the respective sensor probes and relative to a respective one of the potential target nerves that innervate the respective listed muscle.

9. The system of claim 8, wherein the instructions to visually identify include instructions to access the nerve-muscle index, so that upon detecting activation of one of the listed muscles, the corresponding target nerve responsible for activation of the nerve is highlighted within the nerve-muscle index on the graphical user interface.

10. The system of claim 8, wherein the instructions to visually identify include instructions to confirm that the target nerve identified via the index caused the activation of the respective listed muscle via a response time function of the neuromuscular response evaluation module, wherein the response time function indicates whether the activation of muscle was caused by electrical stimulation of the nerve or by direct electrical stimulation of the muscle.

11. The system of claim 8, wherein the nerve-muscle index comprises an array of corroborating parameters including at least one of a muscle response time parameter, a visible muscle action parameter, a muscle motion parameter, or a functional result parameter.

12. The system of claim 11, the functional result parameter to identify a functional result of stimulation of the target nerve, wherein the identified functional result includes at least one of a retraction of a muscle, a protrusion of a muscle, an increase in a cross-sectional area of an airway, a decrease in the cross-sectional area of the airway, an at least partial collapse in the airway, or a maintained cross-sectional shape of the airway, wherein the graphical user interface includes a display of one or more of the identified functional results.

13. The system of claim 1, wherein the instructions to visually identify includes instructions to:

visually indicate on the graphical user interface, via a visual response intensity function, a degree of response by the activated muscles, including the at least one muscle, via a color parameter configured to display a different color for each different degree of response of the activated muscles.

14. The system of claim 1, wherein the instructions to visually identify includes instructions to:

track, per a target muscle parameter, via a first plurality of sensor probes configured to be removably coupled relative to a corresponding plurality of potentially activatable muscles including the at least one muscle, each potentially activatable muscle that is innervated by one of the potential target nerve stimulation sites;

track, per a non-target nerve parameter, via the first plurality of sensor probes, each potentially activatable muscle that is physically adjacent one of the potential target nerve stimulation sites and that is not targeted to be activated; and

track, per a non-target muscle parameter, via a second plurality of sensor probes configured to be removably coupled relative to a corresponding plurality of non-target muscles, each non-target muscle that is physically adjacent one of the target muscles.

15. The system of claim 1, wherein the instructions comprise instructions to:

graphically identify on the graphical user interface, per a path marker function, an intended pathway of percutaneous access, via superimposition on the at least one internal image, based on at least one of a probable target nerve stimulation site or a confirmed target nerve stimulation site.

16. The system of claim 1, wherein the instructions to display at least one internal image comprises instructions to:

access the at least one internal image as a radiographic image including at least one of a magnetic resonance imaging (MRI) image, a computer tomography (CT) image, or a fluoroscopy image, wherein the image source module is configured to obtain the at least one internal image via at least one of electronic medical records or a live image.

17. The system of claim 16, wherein the instructions to display at least one internal image includes instructions to at least one of:

graphically superimpose a generalized patient anatomy map onto the displayed at least one internal image; and

locate fiducial markers onto the at least one internal image.

18. The system of claim 1, wherein the instructions to visually identify includes instructions to:

visually indicate, on the graphical user interface, a degree of response by the activated muscles, including the at least one muscle, via a shading parameter configured to display a different degree of shading for each different degree of response of the activated muscles.

19. The system of claim 1, wherein the instructions to visually identify includes instructions to:

visually indicate, on the graphical user interface, a degree of response by the activated muscles, including the at least one muscle, via a numerical parameter configured to display a different numerical identifier for each different degree of response of the activated muscles.

20. The system of claim 1, wherein the instructions comprise instructions to graphically identify on the graphical user interface, via superimposition of a target spot marker on the at least one internal image, an intended target nerve stimulation site.

21. A surgical graphical user interface comprising:

a display portion;

a controller, including a processing unit; and

a non-transitory memory storing instructions, executable via the processing unit, to;

display, on the display portion, at least one internal image of a patient head-and-neck portion;

visually identify, superimposed on the at least one internal image on the display portion, muscles in the head-and-neck portion that are activated upon application of a stimulation signal to at least one nerve in the head-and-neck portion;

display, via a nerve-muscle response index on the display portion, a first listing of potential target nerves, including the at least one nerve, and a second listing of muscles, wherein each listed muscle is correlated to a respective one of the potential target nerves that innervate the respective listed muscle, wherein upon detecting activation of one of the listed muscles, the corresponding target nerve in the first listing responsible for activation of the nerve is highlighted; and

display on the display portion at least one image of at least one functional result associated with the patient head-and-neck portion, the at least one functional result produced via activation of a respective one of the muscles in the second listing.

22. The system of claim 21, wherein each listed muscle is correlated to one of a plurality of sensor probes, the sensor probes comprising

an array of ultrasound detection nodes with each respective ultrasound detection node to detect muscle motion associated with the response of the respective muscles in the second listing.

23. The system of claim 21, wherein the instructions comprise instructions to display, via the nerve-muscle index on the display portion, a fourth listing of the respective sensor probes, wherein each listed sensor probe corresponds to a respective one of the muscles in the second listing to which the sensor probe is removably coupled.

24. The system of claim 21, wherein the instructions comprise instructions to display, on the display portion, the at least one image of functional result as a live image viewable via endoscopy to enable real-time observation of effect of activation of muscle, wherein the live image provides detection of at least one of a change in a cross-sectional area of an airway or a change in a cross-sectional shape of the airway.

25. The system of claim 21, wherein the instructions comprise instructions to display, via the nerve-muscle index on the display portion, a third listing that includes the at least one functional result, along with the first and second listings, and wherein the at least one functional result in the third listing is highlighted upon occurrence of the at least one functional result.

26. The system of claim 21, wherein the respective listed muscles includes at least one non-target muscle adjacent a target stimulation site on the target nerve.

27. The system of claim 21, wherein the respective listed muscles includes at least one of a non-target muscle adjacent the target muscle.

28. The system of claim 21, wherein each listed muscle is correlated to one of a plurality of sensor probes, the sensor probes comprising at least one of:

an array of compound muscle action potential electrodes; and

an array of impedance electrodes.

29. A system for placing a stimulation element, the system comprising:

a neuromuscular response evaluation module including;

a stimulation engine to apply an electrical stimulation signal to at least one nerve within a patient head-and-neck portion via a stimulation element;

a muscle response portion to determine, via at least sensing in association with at least one sensor probe, a response of at least one muscle to application of the stimulation signal;

a user interface;

a controller including a processing unit;

a non-transitory memory storing instructions, executable via the processing unit, to;

display, on the user interface, at least one internal image of the patient head-and-neck portion;

visually identify, on the user interface, superimposed on the at least one internal image, which muscles in the head-and-neck portion including the at least one muscle were activated for each respective application of the stimulation signal to at least one nerve in the patient head-and-neck portion;

display, on the user interface, a first listing of potential target nerves, including the at least one nerve, and a second listing of muscles, wherein each listed muscle is correlated to a respective one of the potential target nerves that innervate the respective listed muscle, wherein upon detecting activation of one of the listed muscles, the corresponding target nerve in the first listing responsible for activation of the nerve is highlighted; and

display, on the user interface, at least one image of at least one functional result associated with the patient head-and-neck portion, the at least one functional result produced via activation of a respective one of the muscles in the second listing.

30. The system of claim 29, wherein the user interface comprises at least one portion comprising a graphical user interface.