METHOD AND SYSTEM FOR IDENTIFYING A LOCATION FOR NERVE STIMULATION

• US 20130204097A1
• Filed: 03/10/2011
• Published: 08/08/2013
• 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
• Granted Patent: US 9,888,864 B2
• Time in Patent Office: Days
• US Class Current: 600/301
• 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

1-91. -91. (canceled)

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

a neuromuscular response evaluation module including;

a stimulation engine configured to apply an electrical stimulation signal to a patient body portion via a stimulation element; and

a muscle response module configured to determine a response of a muscle to application of the stimulation signal;

a probe interface including an array of ports;

an array of sensor probes, each removably connectable to a respective one of the ports and removably attachable to a body portion corresponding to the muscle, the sensor probe configured to sense the muscle response; and

a graphical user interface including;

an image display module configured to display at least one image of the patient body portion; and

a muscle identifier module configured to visually identify, superimposed on the at least one image, which muscles were activated for each respective application of the stimulation signal.

93. The system of claim 92, wherein the muscle response module comprises:

a stimulation path analyzer configured to differentiate between application of the electrical stimulation signal to a nerve innervating a muscle and direct application of the electrical stimulation signal to the muscle,

wherein the stimulation path analyzer comprises at least one of;

an electromyography circuitry configured to determine the muscle response via electromyography; and

a compound muscle action potential module configured to determine the muscle response via observing a compound muscle action potential.

94. The system of claim 92, wherein the user interface comprises:

a sensor designator configured to track and display a location of each sensor probe on the at least one image from the image display module, wherein the sensor designator is configured to determine the location based on at least one of;

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

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

95. The system of claim 92, wherein at least some of the sensor probes include ultrasound detection nodes.

96. The system of claim 92, wherein at least one of the sensor probes includes at least one of:

a multi-balloon catheter configured to sense, via air pressure, a location of obstruction within an airway; and

an endoscopic imaging device, wherein the endoscopic imaging device is configured to detect 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.

97. The system of claim 92, wherein the user interface comprises:

a target nerve identifier configured to graphically identify on the at least one image a location of a target nerve; and

a target muscle identifier configured to graphically identify on the at least one image a location of a target muscle innervated by the target nerve,

wherein the respective target nerve identifier and target muscle identifier are configured to be user-positionable on the at least one image.

98. The system of claim 92, wherein the user interface comprises:

an actually-stimulated nerve identifier configured to graphically identify on the at least one image a location of the nerve actually stimulated via the applied stimulation signal; and

an actually-activated muscle identifier configured to graphically identify on the at least one image a location of the 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 image upon sensing the muscle activation via a sensor probe coupled to the muscle.

99. The system of claim 92, wherein the graphical user interface comprises:

a nerve-muscle index including a first listing of potential target nerves and a second listing of muscles, 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.

100. The system of claim 99, wherein the muscle identifier module accesses 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 index.

101. The system of claim 99, wherein the muscle identifier module is configured 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.

102. The system of claim 99, 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.

103. The system of claim 102, wherein the functional result parameter is configured to identify a functional result of stimulation of the target nerve, wherein the identified functional result includes at least one of a refraction 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.

104. The system of claim 92, wherein the muscle identifier module includes:

a visual response intensity function configured to visually indicate a degree of response by the activated muscles via at least one of;

a color parameter configured to display a different color for each different degree of response of the activated muscles;

a shading parameter configured to display a different degree of shading for each different degree of response of the activated muscles; and

a numerical parameter configured to display a different numerical identifier for each different degree of response of the activated muscles.

105. The system of claim 92, wherein the muscle identifier module includes:

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

a non-target nerve parameter configured to track, 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

a non-target muscle parameter configured to track, 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.

106. The system of claim 92, wherein the graphical user interface includes at least one of:

a path marker function configured to graphically identify an intended pathway of percutaneous access based on at least one of a probable target nerve stimulation site or a confirmed target nerve stimulation site;

a target spot marker configured to graphically identify an intended target nerve stimulation site; and

a directional function configured to visual indicate, via a graphical representation, a suggested direction in which to move the stimulation element toward a target nerve stimulation site.

107. The system of claim 92, wherein the image display module comprises:

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

wherein the image display module includes at least one of;

an anatomy map module configured to graphically superimpose a generalized patient anatomy map onto the displayed at least one image; and

a fiducials marker module configured to locate fiducial markers onto the at least one image.

108. A surgical interface system comprising:

a graphical user interface including;

an image display module configured to display at least one image of a patient body portion;

a muscle identifier configured to visually identify, superimposed on the at least one image, muscles that are activated upon application of a stimulation signal to a nerve;

a nerve-muscle response index configured to display a first listing of potential target nerves 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

a functional result module configured to display at least one image of at least one functional result associated with the patient body portion, the at least one functional result produced via activation of a respective one of the muscles in the second listing.

109. The system of claim 108, wherein each listed muscle is correlated to one of a plurality of sensor probes, the sensor probes comprising at least one of:

a multi-balloon catheter configured to sense, via air pressure, a location of obstruction within an airway;

an array of ultrasound detection nodes;

an array of electromyography electrodes;

an array of compound muscle action potential electrodes;

or

an array of impedance electrodes.

110. The system of claim 108, wherein the nerve-muscle index includes a fourth listing of the respective sensor probes, wherein each listed sensor probe corresponds to a respective one of the muscles in the first listing to which the sensor probe is removably coupled.

111. The system of claim 108, wherein the at least one image of functional result includes 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.

112. The system of claim 108, wherein the nerve-muscle index includes 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.

113. The system of claim 108, wherein the respective listed muscles includes at least one of:

a target muscle innervated by a target nerve;

at least one non-target muscle adjacent a target stimulation site on the target nerve; and

at least one non-target muscle adjacent the target muscle.

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

a neuromuscular response evaluation module including;

a stimulation engine configured to apply an electrical stimulation signal to a patient body portion via a stimulation element; and

a muscle response module configured to determine a response of a muscle to application of the stimulation signal; and

a graphical user interface including;

an image display module configured to display at least one image of the patient body portion;

a muscle identifier module configured to visually identify, superimposed on the at least one image, which muscles were activated for each respective application of the stimulation signal;

a nerve-muscle response index configured to display a first listing of potential target nerves 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

a functional result module configured to display at least one image of at least one functional result associated with the patient body portion, the at least one functional result produced via activation of a respective one of the muscles in the second listing.