JP7053596B2 - Nerve positioning and mapping - Google Patents

Description

(Mutual reference of related applications)
This application was filed on October 5, 2016, and was published as US Patent Application Publication No. 2017/0020611. US Patent Application No. 15 / 286,317, October 2016, entitled "Method of Mapping a Nerve". US Patent Application No. 15 / 286,323, filed October 5, 2016, entitled "Nerve Mapping System" filed on 5th and published as US Patent Application Publication No. 2017/0020450, US Patent Application US Patent Application No. 15 / 286,328 published as Publication No. 2017/0020451, entitled "Neural Locating Method", US Patent Application No. 15 entitled "Neural Locating Method" filed October 5, 2016. Claim priority over / 286,333.

(Field of invention)
The present invention generally relates to a surgical diagnostic system for detecting the presence of one or more nerves.

Traditional surgical practices place importance on recognizing or verifying the location of nerves and avoiding nerve damage. Advances in surgical technology include the development of much less exposed techniques, such as minimally invasive surgery and the insertion of more complex medical devices.

These advances in surgical techniques require corresponding improvements in methods for detecting and / or avoiding nerves during surgery.

In one embodiment, the method of locating a nerve in a subject's in-vivo treatment area begins with providing a first "search" electrical stimulus at a first position in the in-body treatment area. The first electrical stimulus has a magnitude of the first current that does not elicit a threshold response in the nerve-controlled muscle. As the stimulus probe advances, a second exploratory electrical stimulus is provided at a second location within the therapeutic area within the body. The second electrical stimulus has the same current magnitude as the first stimulus and provokes a muscle response greater than the threshold.

After application of the second evoked stimulus, one or more additional "positioning" electrical stimuli are provided at the second location, each stimulus having a smaller current magnitude than the first stimulus. From these one or more additional electrical stimuli, the magnitude of the minimum current required to elicit a threshold response of the muscle at the second position is determined. This minimum current magnitude is then used to determine the distance from the second position to the nerve.

In another embodiment, the first exploratory electrical stimulus may be applied to a first location within the therapeutic area within the body. The first position is greater than the threshold distance from the nerve, and the threshold distance is the maximum distance at which the first electrical stimulus can elicit a threshold response in the nerve-controlled muscle.

A second position determination electrical stimulus can then be applied to the second position within the treatment area within the body. The magnitude of the current of the second position determination stimulus is smaller than the magnitude of the current of the first search stimulus, and the second position is closer to the nerve than the first position. The magnitude of the muscle response to the positioning electrical stimulus may be monitored, and the magnitude of this response is used to determine the distance from the second position to the nerve, along with the magnitude of the positioning stimulus. May be good.

Each of the first and second positions may be aligned within the virtual workspace, and the portion of the virtual workspace surrounding the first position is shown as nerve-free and virtual. The presence of nerves in the workspace may be indicated at a determined distance from the second position.

In one embodiment, a method of modeling a nerve located within a patient's in-vivo treatment area comprises placing electrodes at multiple locations within the virtual workspace, each of which is different within the in-vivo treatment area. Corresponds to the position. Electrical stimuli are delivered from the electrodes to body tissues at different locations within the body's therapeutic area, and the muscle response to each of the delivered electrical stimuli is monitored by sensors that communicate with the muscles. The distance from each of the different locations to the nerve is determined using the magnitude of the electrical stimulus provided at each location and the monitored response of the muscle to the stimulus provided. From these distances in the virtual workspace and known / aligned electrode positions, a virtual model of the nerve is constructed in the virtual workspace. The virtual model may then be provided on the display and the virtual model may be displayed and / or merged with other anatomical images, or tools and / or disposed within the body treatment area. It may be provided to the robot controller for the purpose of controlling the end effector.

In another embodiment, a method of modeling a patient's in-vivo therapeutic area with respect to the presence of nerves is to monitor the location of one or more electrodes within the in-vivo therapeutic area and to have multiple electricity through one or more electrodes. Includes providing stimulation to the therapeutic area within the body. Each of the multiple electrical stimuli is provided at different locations within the body's therapeutic area, and the nerve-controlled muscles are monitored for their response to each of the multiple electrical stimuli.

The method then follows the magnitude of the electrical stimulus provided to at least one of the different locations and the monitored response of the muscle to the electrical stimulus provided to at least one of the nerve-different positions. Determine the distance between them. Next, the virtual model of the in-vivo treatment area has a first portion representing a nerve at a distance determined from at least one of the different positions and a second portion representing a space within the in-vivo treatment area that does not contain a nerve. Can be constructed to include parts and. Similar to the above embodiments, the virtual model may be provided on a display, the virtual model may be displayed and / or merged with other anatomical images, or placed within the therapeutic area of the body. It may be provided to the robot controller for the purpose of controlling the installed tools and / or end effectors.

In another embodiment, the method of modeling the nerve is to provide multiple electrical stimuli from one or more electrodes to the therapeutic area of the patient's body and to use a non-invasive mechanical sensor to each of the multiple electrical stimuli. Includes monitoring the mechanical response of muscles to. Each of the plurality of electrical stimuli has a magnitude of electric current and is provided at different locations within the therapeutic area within the body. The magnitude of the current of each of the multiple electrical stimuli provided and the monitored mechanical response of the muscle are used to determine the distance between the nerve and each of the different positions. Finally, a virtual model of the nerve is constructed within the virtual workspace using the determined distance between the nerve and each of the different positions.

In one embodiment, the neural mapping system comprises a plurality of electrodes, a sensor, and a processor that communicates with each of the plurality of electrodes and the sensor. Each of the electrodes is located at the distal end of one or more elongated medical devices configured to extend within the subject's body treatment area, and the sensor responds to the monitored response of the muscle. It is configured to provide an output signal.

The processor is configured to receive the indication of each position of multiple electrodes within the therapeutic area of the body and provide electrical stimulation to each electrode so that the stimulus can be transmitted to internal tissues at each of the multiple positions. Will be done. The processor can then receive an indication of the magnitude of the muscle's monitored response from the sensor, and the muscle response is triggered by the electrical stimulation provided. The processor may then use the magnitude of the electrical stimulus provided and the monitored response of the muscle to the stimulus provided to determine the distance from each position of the plurality of electrodes to the nerve. The processor can build a virtual model of the nerve using the determined distance to the nerve at each of the multiple positions, which may be output to the display or within the therapeutic area of the body. It may be provided to the robot controller for the purpose of controlling the tools and / or end effectors of.

In another embodiment, the neural mapping system comprises one or more electrodes and a sensor and each of the one or more electrodes and a processor that communicates with the sensor. Each of the one or more electrodes is disposed at the distal end of an elongated medical device configured to extend within the subject's body treatment area, and the sensor is an output signal corresponding to the monitored response of the muscle. Is configured to provide.

The processor is configured to provide an electrical stimulus to each of the one or more electrodes so that the stimulus can be transmitted to the body tissue at each of the plurality of locations within the body therapeutic area. The processor can receive an output signal from the sensor, which provides an indication of the muscle's response to the electrical stimuli provided at each of the multiple locations. The processor can use the magnitude of the electrical stimulus provided at each of the multiple locations and the received output signal to build a virtual model of the in-vivo treatment area containing the first and second parts. can. The first part represents the nerves that innervate the muscles, and the second part represents the space within the therapeutic area that does not contain nerves. Similar to the first embodiment, this virtual model may be output to a display or provided to a robot controller for the purpose of controlling tools and / or end effectors within the treatment area.

In one embodiment, the method of locating a nerve in the body space is to advance the distal end of the stimulator towards an anatomical target in the body space and the stimulator towards the anatomical target. Includes periodic application of a first electrical stimulus from a first electrode disposed on the central axis of the stimulator while advancing. When a nerve-controlled muscle response to a first electrical stimulus is detected, the position-determining electrical stimulus can be applied from multiple positions offset from the central axis of the stimulator. This method can subsequently monitor the magnitude of the muscle response to position determination electrical stimulation at each of the plurality of positions and determine the distance between the nerve and each of the plurality of positions. The determined distance is used to determine the position of the nerve from the determined distance at each of the plurality of positions.

The above features and advantages of the invention as well as other features and advantages are readily apparent from the following detailed description of the best embodiments for carrying out the invention with reference to the accompanying drawings.

"A", "an", "the", "at least one", and "one or more" are used interchangeably to indicate that at least one of the items is present. There may be more than one such item, unless otherwise stated explicitly. All numerical values (eg, quantities or conditions) of the parameters herein, including the appended claims, are, in all examples, "about" whether or not they actually precede the numerical value. It should be understood as being modified by the term "about". "About" indicates that the numbers given allow for slight inaccuracies (close to the exact value, approximately this value or close enough to the value, approximately). If the inaccuracies provided by "about" are not understood differently in the art, "about" as used herein arises from the usual methods of measuring and using such parameters. At least show the variation you get. Further, the disclosure of the range includes the disclosure of all the values and the range further divided within the whole range. Thereby, each value within the range and all endpoints of the range are disclosed as separate embodiments.

FIG. 3 is a schematic diagram of a neural monitoring system for detecting artificially evoked mechanical muscle responses. FIG. 3 is a schematic graph showing the relationship between the MMG output signal amplitude, the stimulator current, and the distance between the stimulator electrode and the nerve. It is a schematic front view which shows the arrangement of a plurality of mechanical sensors on the leg of a subject. It is a schematic side view of an in-vivo treatment area including a part of the lumbar spine. It is a schematic isometric view of a virtual nerve probability model. It is a schematic data flow diagram for making and using a 3D nerve model. It is a schematic flowchart which shows the method of constructing a neural probability model. It is a schematic side view of the position determination device which can align a stimulator device in a three-dimensional space. It is a schematic 2D side view across the longitudinal axis of the stimulator, showing the creation of a neural probability model using a model-based triangulation method. It is a schematic 2D side view across the longitudinal axis of the stimulator, showing the creation of a neural probability model using a model-based triangulation method. FIG. 6 is a schematic 2D side view across the longitudinal axis of the stimulator, showing the creation of a neural probabilistic model using a model-based triangulation method. It is a schematic 2D side view across the longitudinal axis of the stimulator, showing the creation of a neural probability model using a model-based triangulation method. It is a schematic 2D diagram along the longitudinal axis of a stimulator showing a triangulation method based on a model of multiple nerves. It is a schematic 2D diagram along the longitudinal axis of a stimulator showing a triangulation method based on a model of multiple nerves. It is a schematic flowchart which shows the 1st Embodiment of the adaptive stimulation method based on evidence. It is a schematic flowchart which shows the 2nd Embodiment of the adaptive stimulation method based on evidence. It is a schematic flowchart which shows the adaptive stimulation method based on a model. FIG. 6 is a schematic cross-sectional view in which a plurality of stimulator probes are advanced toward a target region in the body. FIG. 6 is a schematic cross-sectional view in which a plurality of stimulator probes are advanced toward a target region in the body. FIG. 3 is a schematic perspective view of a stimulator having a tip electrode and a single offset electrode. FIG. 15A is a schematic end view of the stimulator of FIG. 15A. It is a schematic perspective view of a stimulator having a tip electrode and a plurality of offset electrodes. FIG. 16A is a schematic end view of the stimulator of FIG. 16A. FIG. 3 is a schematic of a robotic controlled surgical system including a neural monitoring system for detecting the position of a surgical tool with respect to a nerve. It is a schematic diagram of a robot controller. FIG. 3 is a schematic cross-sectional view of the distal end of an elongated surgical instrument that moves relative to a subject's nerves. FIG. 19 is a schematic cross-sectional view of FIG. 19 in which a virtual barrier stands upright around a nerve.

Referring to the drawings, similar reference numbers are used to refer to similar or identical components in various figures, FIG. 1 identifying the presence of one or more nerves within subject 14's in-vivo treatment area 12. The neural monitoring system 10 that can be used to do so is schematically shown. As described in more detail below, in one configuration, the system 10 monitors one or more muscles of subject 14 for mechanical movement, and the mechanical movement is artificial to the stimulus provided. A mechanical response of a mechanically induced muscle (also referred to as an "artificially induced mechanical muscle response") or another factor (eg, muscle contraction / relaxation and / or intended by the subject). Or it can be determined whether the exercise is caused by (exercise caused by the environment). If an artificially evoked mechanical muscle response is detected during the procedure, the system 10 can display to the user, such as through a display, or perform another appropriate action.

As used herein, an artificially evoked mechanical muscle response is the contraction or contraction of muscles in response to stimuli that are not perceived through natural sensory means (eg, vision, hearing, taste, smell, and touch). Refers to relaxation. Rather, it is muscle contraction / relaxation that is triggered by direct stimulation of the nerves that innervate the muscle. Examples of stimuli that can cause an "artificially induced" muscle response include a current applied directly to a nerve or body tissue or fluid that directly surrounds the nerve. In this example, if the applied current is strong enough and / or close enough to the nerve, the nerve can be artificially depolarized (resulting in contraction of the muscles innervated by the nerve). can. Other examples of such "artificial stimuli" include mechanically induced depolarization (eg, physically stretching or compressing nerves using tissue retractors, etc.), heat-induced depolarization (eg, eg). It can include (through ultrasonic ablation) or chemically-induced depolarization (eg, through application of chemicals to the tissue surrounding the nerve).

During an artificially evoked mechanical muscle response, the muscles dominated by artificially depolarized nerves can physically contract or relax (ie, mechanical response). Such mechanical reactions can occur primarily along the longitudinal direction of the muscle (ie, alongside the muscle's constituent fibers), but substantially laterally (for most skeletal muscles, to the skin). It may also result in further expansion / relaxation of the muscles (which can be vertical). Local movement of the muscle during an artificially evoked mechanical muscle response can be measured relative to the position of the muscle in the unstimulated state, distinguishing it from other overall translations of the muscle.

The neural monitoring system 10 may include a processor 20 that communicates with at least one mechanical sensor 22. The mechanical sensor 22 may include, for example, a strain gauge, a force converter, a position encoder, an accelerometer, a piezoelectric material, or any other transducer or combination of transducers capable of converting physical motion into a variable electrical signal.

Each mechanical sensor 22 may be specially configured to monitor the local mechanical movement of the subject 14's muscles. For example, each sensor 22 is a fixing means such as an adhesive / patch that can adhere, bandage, or otherwise attach the sensor 22 to the skin of the subject 14 (ie, stick to the outer surface of the skin). May include. Other examples of suitable fixing means may include a bandage, a sleeve, or other elastic fixing means capable of holding the sensor 22 in physical contact with the subject 14. Alternatively, the mechanical sensor 22 (and / or coupling device) may be configured to monitor local mechanical movements of the muscle by its physical design. For example, the sensor / coupling device may be placed within the lumen or natural opening of the subject to react to the lumen or opening, or to the muscles directly adjacent to and / or connected to the lumen or opening. It may include a catheter, balloon, occlusal guard, open plug, or endotracheal tube that can be monitored. In a preferred embodiment, the mechanical sensor is a non-invasive device and the term "non-invasive" means that the sensor is surgically (i.e., through a tissue incision) placed in the subject's body to achieve its placement. It is intended to mean that it has not been done. For the purposes of the present disclosure, the non-invasive sensor may include a sensor disposed within a natural lumen that is accessible without the need for an incision.

In one configuration, the sensor 22 may include a contact detection device capable of displaying if the sensor 22 is in physical contact with the skin of the subject 14. The contact detection device may include, for example, a pair of electrodes configured to contact the subject 14's skin when the sensor 22 is properly positioned. The sensor 22 and / or the contact detection device may then monitor the impedance between the electrodes to determine if the electrodes are in contact with the skin. Other examples of suitable contact detection devices can include capacitive touch sensors or buttons that project slightly beyond the surface of the sensor.

The system 10 may further include one or more elongated medical devices 30 (ie, also referred to as a stimulator 30) capable of selectively providing the stimulus within the body treatment area 12 of the subject 14. For example, in one configuration, the elongated medical device 30 may include a probe 32 (eg, a ball-shaped tip probe, k-wire, or needle) having one or more electrodes 34 disposed at the distal end 36. good. Electrodes 34 may be selectively energized in response to either a user / doctor's request or a command from processor 20 to apply electrical stimulation 38 to the body tissue of subject 14. For some procedures, the elongated medical device 30 may include a dilator, retractor, clip, cautery probe, vertebral pedicle screw, or any other medical device that can be used in invasive medical procedures. Regardless of the device, if the intended artificial stimulus is an electric current, the device 30 is one or more disposed on a portion of the device intended to contact tissue within the body treatment area 12 during the procedure. The electrode 34 which can be selectively energized may be included.

During the surgical procedure, the user / surgeon can selectively apply a stimulus to the body tissue within the treatment area 12 to identify the presence of one or more nerve bundles or fibers. In the case of the electrical stimulus 38, the user / surgeon can provide the stimulus by pressing, for example, a button or foot pedal that communicates with the system 10, more specifically with the stimulator 30. The electrical stimulus 38 may be, for example, a discrete pulse (eg, a step pulse) having a pulse width in the range of about 30 μs to about 500 μs. In other embodiments, the discrete pulse may have a pulse width in the range of about 50 μs to about 200 μs, or in the range of about 75 μs to about 125 μs. The discrete pulse may be periodically applied, for example, at a frequency of about 1 Hz to about 10 Hz.

When the nerve extends within a predetermined distance of the electrode 34, the electrical stimulus 38 depolarizes the nerve, resulting in mechanical spasm of the nerve-controlled muscle (ie, an artificially evoked mechanical muscle response). ) Can be brought. In general, the magnitude of response / spasm can directly correlate with the distance between the electrode and the nerve and the magnitude of the stimulating current. FIG. 2 is a graph 50 showing these relationships, where the sensed response magnitude 52 is shown as a function of the distance 54 between the stimulator and the nerve and the magnitude 56 of the applied current stimulus. .. In one configuration, the relationships shown in FIG. 2 (or variants thereof) may be stored in a look-up table associated with processor 20. A look-up table is then used by the processor 20 to provide an approximate distance 54 between the electrode 34 and the nerve given a known stimulus magnitude 56 and a measured mechanical muscle response magnitude 52. Can be provided.

Referring again to FIG. 1, one or more mechanical sensors 22 may be placed in mechanical communication with one or more muscles of the subject 14 prior to initiating the surgical procedure. In this context, the sensor 22 moves the muscle through either direct contact with the muscle or a mechanical relationship through one or more intermediate materials and / or tissues (eg, skin and / or subcutaneous tissue). , Velocity, acceleration, strain, or other physical reaction can be mechanically communicated with the muscle.

FIG. 3 shows an example of the arrangement of a plurality of mechanical sensors 22 for surgical procedures that may be performed in close proximity to the L2, L3, and / or L4 vertebrae of the lumbar spine (schematically shown in FIG. 4). Thus, nerves 60, 62, and 64 exiting holes 66, 68, 70 of L2, L3, and L4 are within the treatment area 12 (ie, the area surrounding the vertebrae of L2, L3, and / or L4). Or it may be directly adjacent to this area. With general anatomical knowledge, the surgeon can understand that damage to these nerves 60, 62, 64 can affect the function of the vastus lateralis and tibialis anterior muscles. Therefore, the surgeon may place mechanical sensors 22a-22d on or near the vastus lateralis and tibialis anterior muscles to prevent inadvertent manipulation of the nerve during the procedure. For example, mechanical sensors 22a and 22b are disposed on the tibial vastus lateralis muscle controlled by nerves 60, 62 exiting holes 66, 68 of L2 and L3, and sensors 22c and 22d are nerves exiting hole 70 of L4. It is placed on the tibialis anterior muscle, which is controlled by 64.

In general, each mechanical sensor 22 can generate a mechanomyogram (MMG) output signal (scheduled as 72 in FIG. 1) corresponding to the perceived mechanical movement / response of adjacent muscles. The MMG output signal 72 may be either a digital or analog signal, typically via either wired or wireless communication means (eg, by physical wire, or by IEEE 802.11, etc.). Can be provided to the processor 20 (using the radio frequency communication protocol of the) or another protocol such as Bluetooth. As a particular signal, the MMG output signal 72 is intended to be separate and distinct from any potential of the muscle or skin (often referred to as an electromyogram (EMG) signal). Electrical (EMG) and mechanical (MMG) muscle responses can be related, but their relationship is complex and difficult to explain (eg, the potential is very position-specific and of interest muscles. The potential can potentially fluctuate throughout the volume).

Referring to FIG. 1 again, the processor 20 may communicate with the stimulator 30 and the mechanical sensor 22 or may be configured to receive the MMG output signal 72 from the mechanical sensor 22. Processor 20 is a digital signal processor (DSP) with one or more digital computers, a data processor, and / or one or more microcontrollers or central processing units (CPUs), read-only memory (ROM), random. Access memory (RAM), electrically erasable programmable read-only memory (EEPROM), high-speed clock, analog-digital (A / D) circuit, digital-analog (D / A) circuit, input / output (I / O) circuit And / or can be embodied as one of signal conditioning and buffering electronic devices.

The processor 20 automatically executes one or more signal processing algorithms 80 or methods so that the sensed mechanical movement (ie, via the MMG output signal 72) is artificially induced mechanical muscle. It can be configured to determine whether it represents a response or simply a muscle movement intended by the subject and / or a movement due to the environment. These processing algorithms 80 may be embodied as software or firmware, may be stored locally in the processor 20, or may be readily assignable by the processor 20.

As mentioned above, during the invasive procedure, the processor 20 provides an electrical stimulus 38 to the electrode 34 with a known or measurable current magnitude and by measuring the magnitude of the mechanical muscle response. The distance between the electrode 34 and the nerve can be determined. In one configuration, the surgeon can infer the relative position of the nerve by dithering the stimulator 30 and monitoring changes in the magnitude of the response (ie, the closer the stimulator 30 is to the nerve, the more the response. Will be larger). In another embodiment, the system 10 may be configured to automatically determine the position of the nerve with respect to the stimulator 30 without the need for mechanical dithering. For example, the stimulator 30 may include a plurality of electrodes that can be collectively used to triangulate the position of the nerve.

Any electrode disposed on the stimulator 30 is preferably configured to first make contact with body tissue while the probe advances longitudinally. This maximizes the likelihood that each electrode will maintain contact with the tissue. Examples of designs for placing the electrode on the tip surface include placing the electrode on the tip of the probe, placing the electrode on an inclined or conical forward surface, and / or placing the electrode radially outside the peripheral surface. It can be extended / projected toward the direction.

The techniques described above are useful for providing real-time directional references to the user, but in further expansion, the processor 20 is configured to create and maintain a 3D neural model 100 as shown in FIG. May be good.

FIG. 6 schematically shows a data flow diagram for creating and using a 3D neural model. As shown, the processor 20, along with the known position 104 of the electrode 34, is between the stimulator electrode 34 and the nerve as determined by a position sensor, a position determination device, or a kinematic algorithm (generally indicated by 106). Using the determination distance 54, a 3D neural probability model can be constructed at 108. As described above, the determination distance 54 may be a function of the stimulus intensity 56 and the amplitude of the MMG response 52, or may be determined at 110 using the established relationship as shown in FIG. In one configuration, the processor 20 is given a variable stimulus current 56 and a variable MMG response 52 and can directly solve the distance 54 using these relationships. In another configuration, the processor 20 may determine a threshold MMG response level indicating "response" and then determine the minimum stimulus current 56 required to elicit this threshold response. From this minimum current, the distance can be easily calculated and / or inferred.

Once created, the neural model 100 may be output via the display at 112, provided to the robot controller at 114, or sent to the approach route planning module 116 (then). It may be output to the display 112 and / or the robot controller 114). The displayed model may be either viewed as an independent model or merged with other images, for example. When sent directly to the robot controller 114, the model 100 can utilize, for example, feedforward robot control techniques to provide more accurate and dynamic tool control in the vicinity of the nerve. The approach route planning module 116 is implemented in software and can merge the neural model 100 with a separate anatomical model to optimize the ideal tool / surgical approach route towards the anatomical target. .. Finally, in some configurations, the determined nerve distance 54 may also be displayed to the user as an information metric at 112.

In one configuration, the processor 20 is three-dimensional by sampling / stimulating at different positions in the body space, triangulating the nerve position, and progressively constructing and / or refining the nerve model 100. The neural model 100 can be constructed (108). In one configuration, this triangulation may be performed using geometric equations (ie, a triangle can be constructed between the nerve and two known stimulus positions, and the position of the nerve is 3 of the triangle. It can be elucidated by knowing the distance between all two vertices). In another embodiment, a model-based triangulation method may be performed, as schematically shown in FIGS. 7, 9A-9D, and FIGS. 10A and 10B. This model-based triangulation method can be proven to be less computationally intensive in terms of model construction than alternatives based on geometric equations.

Method 120, schematically shown in FIG. 7, generally operates under the assumption that the stimulator electrode 34 transmits current to the surrounding tissue substantially uniformly in all directions. Thus, if the nerve is stimulated and the distance is determined (as described above), the nerve may be present at several locations on the shell surrounding the electrodes at the determined distance. Conversely, if no threshold muscle response is detected, it can be assumed that there are no nerves within the radius of the electrode as defined by the magnitude of the stimulus. By aggregating shells constructed from multiple electrode positions, the system can define areas that are likely to represent nerves, based on the recorded shell densities. In practice, this is a model-based triangulation method.

Method 120 can be initiated by segmenting the virtual 3D workspace 150 (shown in FIG. 5) into multiple voxels (122). As is well understood in computer graphics and modeling, a "voxel" is a three-dimensional element that is a delimited subdivision of a large volume (ie, a large 2D region or a defined subdivision of an image). Similar to 2D pixels). Each voxel has a spatial position relative to the surrounding voxels and can retain its assigned value. The virtual 3D workspace 150 may be aligned with the corresponding physical 3D workspace 152 (shown in FIG. 1) that includes the internal site 12. Alignment generally involves establishing a relationship between the coordinate spaces of two workspaces so that they correspond directly to each other. For robotic surgical procedures, the virtual workspace 150 may match, for example, the physical workspace 152 accessible by the robot.

Once the virtual workspace 150 is created and aligned with the physical workspace 152, one or more stimulation electrodes 34 within the physical workspace can be aligned / positioned within the virtual workspace 150 (124). ). In one configuration, the electrode position within the physical 3D workspace 152 may be determined by the position determination device 106 and / or a kinematic algorithm.

In one embodiment, the position determination device 106 used to detect the position of one or more electrodes 34 within the physical workspace 152 can be anchored to the stimulator 30 and the position of the stimulator throughout the modeling procedure. May include a multi-axis spatial input device 154 capable of monitoring. An embodiment of the spatial input device 154 is schematically shown in FIG. In this design, the spatial input device 154 is equipped with multiple instruments capable of monitoring the physical position of the stimulator 30 with three spatial dimensions (x, y, and z) and three orientations (roll, pitch, and yaw). A rotatable joint 156 may be included. In this way, the position of the distal end can be adjusted and provided to the processor 20. Examples of commercially available spatial input devices having such properties include Touch Haptic Input Device or Phantom Haptic Input Device manufactured by Geomatic Solutions. Similarly, the position of one or more electrodes 34 may be determined by the joint motion / kinematics of the surgical robot that actively controls the position and posture of the stimulator 30 throughout the procedure.

In yet another embodiment, the one or more electrodes 34 are positioned within the physical 3D workspace 152 by monitoring the position of the distal end of the stimulator 30 using a non-contact positioning device. May be good. An example of a non-contact positioning device utilizes ultrasound, electric field, magnetic field, fluorescence fluoroscopy, or optical recognition to place a stimulator (ie, the distal end of the stimulator) in three-dimensional space. be able to.

Referring again to FIG. 7, once the relative positions of one or more electrodes 34 are aligned within the virtual workspace (124), it is assumed that the distal end of the stimulator 30 has advanced to the internal position. The current 38 can be applied to the surrounding body tissue via the electrode 34 (126). If a threshold MMG response is detected (128), the processor 20 may determine the distance between the electrode 34 and the nerve (130) and update the nerve model (132). Alternatively, if no threshold MMG response is detected (128), processor 20 may proceed directly to update the neural model (132). As mentioned above, in one configuration, determining the distance (130) may include determining the distance directly from the magnitude of the variable stimulus and the magnitude of the variable MMG response. In another configuration, determining the distance (130) determines the minimum stimulus current required to elicit a threshold response at the stimulus position and uses that minimum evoked current to determine the distance. And may be included. In the above embodiment, determining the minimum stimulus current may include providing one or more additional "positioning" electrical stimuli whose intensity is progressively diminished until the threshold response is no longer evoked. ..

In general, the process of updating the model (132) involves progressively refining the voxel model to distinguish between "safe" and potentially neural areas. 9A-9D schematically show this process. As shown, each voxel 160 in the workspace 100 can have one of three states: no information, no nerve (ie, "safe"), and nerve. In one configuration, no information may be represented by an empty or "null" value, no nerve may be represented by zero, and "nerve" may be represented by an integer value greater than or equal to 1.

First, all voxels 160 may be initialized to "no information". If the stimulus is delivered (126) and the threshold muscle response is not measured / detected (128), the processor 20 can conclude that the nerve is not within a predetermined radius of the electrode. Therefore, the processor can change all voxels in this region 162 to "nerveless" as shown in FIG. 9A and shown in 134 of FIG. Once the voxel 160 is painted as "safe" (ie, nerveless), the voxel should remain in that state indefinitely. If the stimulus is delivered and the nerve 164 is detected at a particular distance as shown in FIG. 9B, the shell 166 may be constructed with a radius equal to the determined distance and all voxels 160 consistent with the shell 166. Is changed to "1" (represented by 136 in FIG. 7) (ie, excluding voxels already identified as safe). Further, since the determined distance generally represents the minimum distance to the nerve 164, all voxels 160 inside the shell are considered "safe" and may be changed to "no nerve" (see 138 in FIG. 7). expressed).

Referring to FIG. 7, after each test, if further model subdivision is required (140), the electrode 34 may be rearranged within the physical 3D workspace / internal region (142). Other positions may be tested via the MMG stimulation routine. Subsequent shells 166 can be constructed by sampling at many different locations as shown in FIG. 9C, and voxels with two or more shells are incremented to a value that reflects the number of shells at that point. Can be made to. Once a sufficient number of points have been tested, the voxel model can be smoothed and filtered so that only voxels with values above a certain threshold remain (generally represented in FIG. 9D) (144). .. The remaining structure 168 provides a 3D stochastic neural model 100 that represents the actual neural structure.

In one configuration, this same technique can be used to map multiple different nerves at the same time. This concept of a multi-nerve model relies on multiple mechanical sensors dispersed around the body to communicate with various muscle groups as schematically shown in FIG. Each sensor can be viewed as a unique channel that can be used to determine the distance to the nerve that primarily controls each group. The nerve may be stored in different "layers" of the model 100 once identified and positioned by the processor 20. Once the mapping is complete, the various separate layers may be merged together to form the final neural map 100.

FIGS. 10A and 10B schematically show a multineural technique used to identify two different nerve bundles 170, 172. As illustrated, the system can construct a first plurality of shells 174 by identifying the mechanical response of the muscle to the stimulus of the first nerve fascicle 170 (shown in FIG. 10A). Following or at the same time as the creation of the first plurality of shells 174, the system constructs the second plurality of shells 176 by identifying the mechanical response of the muscle to the stimulation of the second nerve fascicle 176. You may. In one configuration, each of these nerves is within the model to prevent the reading of the first nerve bundle 170 from erroneously affecting the reading of the second nerve bundle 172 (or vice versa). May be maintained separately.

Referring to FIG. 6 again, once the 3D neural model 100 is created, it can be output to the display device at 112, either as an independent model or merged with any other image / anatomical model. .. For example, in one configuration, the neural model 100 is aligned with a three-dimensional CT or MRI model using anatomical targets / reference points, known coordinate transformations, or other techniques that merge different anatomical imaging modalities. Can be merged. In another configuration, the 2D diagram of the model may be superimposed on, for example, a 2D fluorescence image or an ultrasound image. To enhance clarity / visibility, the graphical superposition of the neural model 100 may be provided in color, which is quite different from traditional black and white 2D images.

In another embodiment, the neural model 100 may be output to the robot controller 114 for real-time guidance purposes. More specifically, the neural model 100 may notify the robot controller 114 of the internal environment and / or may demarcate one or more boundaries or constrained regions that constrain the movement of the end effector. In this sense, the model 100 can support arbitrary feedforward control (while any real-time MMG detection can serve as feedback control).

In yet another embodiment, the neural model 100 can be used with the anatomical model to calculate the optimal surgical approach route to the anatomical target. More specifically, the neural model 100 may be merged with an anatomical model representing an in-vivo therapeutic area, or a portion of the anatomical model may be identified as an "anatomical target". This target may be the final destination of the surgical instrument and / or the procedure, generally may identify a structure such as an intervertebral disc, or more narrowly identify any particular site of the procedure. You may.

Once the anatomical target is identified, the processor 20 uses one or more optimization routines to determine the optimal approach route from the outer surface of the anatomical model to the anatomical target and the neural model. The possibility of contact with the nerves represented within 100 can be minimized. In addition, optimization can be minimized, taking into account contact with at least one constrained / blocked anatomical structure located between the outer surface of the model and the anatomical target. Examples of blocking structures can include organs such as the intestine, kidneys, liver, or bones such as ribs or pelvis / iliac crest. In particular, the "optimal" entry path is the shortest linear (or non-linear) path to reach the anatomical target while minimizing the possibility of contact with nerves or other constrained physical structures. It may be an approach route. Such pathway planning ability is applied to the Kambin triangle (to the intervertebral disc partially defined by the nerve roots) when attempting to pass through areas with unclear and / or complexly defined neural paths, such as within the lumbar muscles. Traditionally difficult to access when attempting to access a very specific location adjacent to an important nerve, such as a connection to a small access window), or due to delimited anatomy, such as the L5-S1 disc. It can be especially useful when approaching a position.

Once the optimal route is defined, it can either be displayed alone or superimposed / merged with the anatomical model to guide the surgeon to perform the access procedure. can. For example, an image of a probe (eg, a fluorescent image or a computer image) can be represented in the first mode (eg, green) if the probe is on the optimal path and if the probe is off the optimal path. Can be represented in a second mode (eg, red). In addition (or instead), the optimal path may be sent to the robot controller to constrain the movement of the robot-controlled tool and / or end effector within a given tolerance of the path, or along the path. May provide a fully automated approach. In one configuration, the robot controller 114 can operate to simply constrain the movement of the tool under the surgeon's primary (manual) control.

In general, the purpose of this modeling routine is to facilitate faster and safer surgical access than is possible with conventional procedures. To further this end, in one configuration, the system can alternate between low resolution "search currents" and high resolution "positioning currents" to classify body tissues as quickly as possible. Adaptive stimulus technology can be used. In general, the exploratory current stimulus may be a high current that can characterize a large area more quickly, while the position determination current may be a low current stimulus that can be more accurately focused on a particular location of the nerve. These adaptive stimulus techniques are like painting walls with a variety of different sized brushes. It is certainly possible to paint the entire wall with the smallest and finest brushes to ensure control, but when painting the center of a large area with a large brush (or roller) and further control and precision are required. It would be more efficient to switch to a finer brush only.

11-13 schematically show three embodiments of adaptive stimulus techniques that attempt to balance the detection rate provided by the large stimulus current with the accuracy enabled by the small stimulus current. Specifically, FIG. 11 shows a first embodiment of the evidence-based adaptive stimulation method 180, FIG. 12 shows a second embodiment of the evidence-based adaptive stimulation method 181 and FIG. 13 shows a model. The adaptive stimulation method 182 of the base is shown.

Referring to FIG. 11, the first embodiment of the evidence-based adaptive stimulation method 180 typically operates with each stimulation with a large search current during the procedure until an MMG reaction is detected. In this way, the processor 20 can paint the largest possible area as "safe" with a minimum number of stimuli / samples. Once the reaction is detected, the processor 20 can shift down to a smaller position determination current to determine the nerve position more accurately (ie, at the expense of speed).

As shown in FIG. 11, method 180 is initiated from 184 by applying a search stimulus current as it enters the in-vivo treatment area 12. If no MMG response is detected (186), processor 20 may update the model as described above with respect to FIG. 7 (132). The electrodes may be rearranged (142) and the processor 20 may reapply the search stimulus (184). At some point, if an MMG response is detected in response to an applied search stimulus, the processor 20 then applies a small position determination stimulus current to more accurately determine the distance to the nerve (130). May be (188). Once the distance is determined in response to a position determination stimulus, the processor updates the model (132), rearranges the electrodes (142), and then stimulates again using only a small position determination current. Can be done (188).

In the embodiment shown in FIG. 12, the purpose of the "search stimulus" is to identify a safe area, and the purpose of the "position determination stimulus" is to specify the position of the nerve. In general, this technique only determines the exact location of a nerve if it is in close proximity to the stimulator, otherwise it is more important to know where the nerve is not located. Method 181 is the method 180 shown in FIG. 11, except that if an MMG response is detected after application of the search stimulus (186), the stimulus level is reduced (190) and then compared to the threshold (192). Is similar to. If the reduced search current level is still greater than the threshold (ie, still sufficiently large), the reduced search current may be reapplied to see if a neural response remains (ie). 184). If the reduced search current level is below the threshold (192), method 181 can downshift to position determination mode and apply a high resolution position determination stimulus to determine the position of the nerve. In general, the threshold (192) is the current level that defines the difference between the two modes and between the "search stimulus" and the "positioning stimulus". In one configuration, the threshold may be set by the user based on the comfort perceived by the procedure. In another configuration, the threshold may be in the range of about 6 mA to about 12 mA. It should also be understood that the order of reducing stimuli (190) and comparing to thresholds (192) is less important and may be reversed.

The model-based adaptive stimulation method 182 shown in FIG. 13 is general in human anatomy because the processor 20 selects whether to apply a search stimulus or a position determination stimulus in consideration of the possibility of a proximity nerve. With understanding, it is very similar to method 181 of FIG. 12, except that it uses the degree of position of the electrode 34. For example, in areas where nerves are unpredictable, processor 20 may attempt to identify safe areas using a larger search current. Conversely, as the stimulator / electrode approaches the area where the nerve is expected (based on the anatomical model), the processor 20 reduces the current and begins painting the area with finer resolution, and / Alternatively, the position of the nerve can be determined more accurately.

As shown in FIG. 13, method 182 begins by comparing the electrode position 104 with the model of neural structure 194 to estimate the distance between the electrode 34 and the nerve (196). In this embodiment, the model of neural structure 194 may be a pre-acquired model of the actual patient (eg, from CT or MRI), or is a more general model of the "average" person. You may.

Once the nerve distance is estimated (196), the estimated value is compared to the threshold (198) to determine whether a search current is applied (200) or a position determination current is applied (202). The threshold may be, for example, a threshold similar to that used in 192 of FIG. 12 (and / or a distance threshold corresponding to the stimulus threshold of FIG. 12).

If the estimated distance is greater than the threshold (198) and a search current is applied (200), the processor 20 then examines whether the MMG response was stimulated (204). If no MMG response is detected, method 182 proceeds to update the model because the nerve is not within the search radius (132). However, if a response is detected, the processor 20 may apply a position determination stimulus to determine the unexpected distance to an existing nerve (198).

If the estimated distance is less than the threshold (198) and a position determination current is applied (202), the processor 20 then examines whether the position determination stimulus has triggered an MMG response (206). If no response is detected, processor 20 may choose to apply a search stimulus to further explore the region (200). However, if a response to a position determination stimulus is detected, the processor 20 may determine the distance to the nerve (130) and update the model (132). Following the model update, the electrodes can be rearranged (142) and the process can be repeated. If processor 20 fails to sense the expected MMG response at 204 or 206, processor 20 attempts to adjust the anatomical model 194 to take into account newly acquired neural response information (208). Can be done. For example, the processor 20 can attempt to stretch, distort, scale, or rotate parts of the anatomical model to better match the neural model 100.

It should be understood that any of the adaptive stimulation techniques described in connection with FIGS. 11-13 (or variants thereof) can be used in the neural modeling techniques described above. Specifically, the nerve model 100 may operably model the presence of one or more nerves and / or the absence of any nerve.

As schematically shown in FIGS. 9C, 10A, and 10B, the electrodes must be able to be stimulated at multiple locations throughout the body treatment area 12 in order to properly construct the neural model. Stimulation along a single insertion axis may not provide the ability to accurately triangulate nerve position. Therefore, as shown in FIGS. 14A and 14B, in the first embodiment, a plurality of thin stimulator probes 210 (eg, K-wire type probes), each probe having an electrode at its distal end, are used. Stimulation can be performed over the entire therapeutic area 12 in the body.

As shown in FIG. 14A, in the first configuration, each probe may be inserted into the patient's skin 212 at different positions. Despite various insertions, each probe 210 may extend along its own trajectory converging towards the target position / region 214. As a slight variation on this concept, FIG. 14B shows a plurality of thin stimulator probes 210 extending within probe arrays 216 arranged in close proximity, with each probe 210 parallel to the other probes. be. The probe array 216 may be inserted together through a single incision in the skin to minimize total access points.

In the configuration shown in FIG. 14A or FIG. 14B, each probe 210 can allow independent movement and independent stimulation. In this way, if it is known that the trajectory of one probe can intersect the nerve, the remaining probe can be advanced while the longitudinal progression of this probe can be stopped.

In another embodiment, the mapping may be performed using one or more multi-electrode stimulators. 15A and 15B and FIGS. 16A and 16B show two embodiments of the multi-electrode stimulator 220 and 222 that can be used in this mapping process. Each embodiment 220, 222 generally shows a tip electrode 224 disposed on the distal tip 226 with one or more electrodes 228 offset from the longitudinal axis 230 of the stimulator. More specifically, the stimulator 220 shown in FIGS. 15A and 15B is depicted with a single offset electrode 228, and the stimulator 222 shown in FIGS. 16A and 16B is depicted with a plurality of offset electrodes 228. It has been.

In either embodiment, each electrode 224, 228 may be selectively and independently energized in the direction of the processor 20 and may be configured to provide electrical stimulation 38 to the tissue of subject 14. Similarly, the electrodes 224 and 228 are preferably disposed on the stimulator so that they first come into contact with body tissue as the probe advances longitudinally. This maximizes the likelihood that each electrode will maintain contact with the tissue.

During the mapping procedure, in one configuration, the stimulator 220 shown in FIGS. 15A and 15B can generate a 3D stimulator array by rotating while the stimulator is advancing longitudinally. In this way, the tip electrode 224 and the offset electrode 228 may traverse the spiral pattern. In another embodiment that may provide a faster mapping procedure depending on the situation, the tip electrode 224 may be considered a nerve "search electrode" and the offset electrode 228 may be a "triangular electrode". In this embodiment, the tip / search electrode 224 may be the only electrode used while advancing the stimulator (ie, the only electrode that provides the search current). However, once the nerve is detected, the stimulator 220 may be rotated with the offset / triangulation electrode 228 to provide position determination stimuli to multiple points throughout the rotation. Such use of the offset / triangulation electrode is schematically shown in FIGS. 10A and 10B (ie, multiple stimulation sites traverse the arc around the central electrode).

In another embodiment, the need to rotate the stimulator can be reduced or eliminated by including a plurality of offset electrodes 228 as shown in FIGS. 16A and 16B.

One embodiment of the method of utilizing the stimulators of FIGS. 15A and 15B and FIGS. 16A and 16B is to advance the distal end 36 of the stimulator 32 towards an anatomical target in the body space. include. A first (search) electrical stimulus can be applied from the tip electrode 224 disposed on the central axis 230 of the stimulator 32 while the stimulator 32 is advancing towards the anatomical target. When the processor 20 detects the response of the nerve-controlled muscle in the body space to the search electrical stimulus, the position determination electrical stimulus may be applied from a plurality of positions offset from the central axis 230 of the stimulator 32. The processor 20 then monitors the magnitude of the muscle response to the position determination electrical stimulus at each of the plurality of positions and uses the magnitude of the response and the magnitude of the position determination electrical stimulus provided at each of the plurality of positions. Therefore, the distance between the nerve and each of the plurality of positions can be determined, and the position of the nerve can be triangulated from the determined distance at each of the plurality of positions. When the stimulator 220 shown in FIGS. 15A and 15B is used in this method, the processor 20 uses a single offset electrode 228 to provide stimulation during continuous rotation of the stimulator 220. The stimulus can be applied at the offset position of.

FIG. 17 schematically illustrates an embodiment of a robotic surgical system 250 that can use this nerve detection / modeling technique. Such a system is further described in US Patent Application No. 13 / 428,693, filed March 23, 2012, entitled "ROBOTIC SURGICAL SYSTEM WITH MECHANOMYOGRAPHY FEEDBACK", which is disclosed by reference. The full text of is incorporated herein.

As illustrated, an exemplary embodiment of the robotic surgical system 250 includes a nerve detection processor 20 and a robot controller 114. The robot controller 114 is configured to control the movement of the elongated surgical instrument 252, including the proximal end 254 and the distal end 256.

During the surgical procedure, the surgical instrument 252 may extend through the opening 258 in the body of the subject 14, the distal end 256 is disposed within the body treatment area 12, and the proximal end 254 is. It may be arranged outside the subject 14. In one configuration, the surgical instrument 252 may typically be defined by a rigid elongated body 260 such that the movement of the proximal end 254 of the instrument 252 can result in predictable movement of the distal end 256. In another configuration, the surgical instrument 252 may be defined by a controllable flexible body such as an endoscope.

The surgical instrument 252 may further include an end effector 262 disposed at the distal end 256. The end effector 262 may be involved in performing one or more cutting, grasping, cauterizing, or excision functions, with at least one degree of freedom (ie, movable degrees of freedom such as rotation, or selective excision energy). It may be selectively operable by the degree of freedom of electricity such as delivery). In addition, the end effector 262 is configured to selectively rotate and / or articulate around the distal end 256 of the surgical instrument 252, allowing for greater range of motion / agility during the procedure. You may. The end effector 262 and / or the distal end 256 of the instrument 252 may include multiple electrodes (generally as described above, each electrode may provide its own electrical stimulus 38 to the tissue within the treatment area 12. Can be configured).

In one embodiment, as schematically shown in FIG. 17, the end effector 262 may be configured to resemble forceps and has one or more controllable tailored joint movements around a hinged joint. May have movable jaws. Selective articulation of one or more jaws may be enabled, for example, by a cable or pull wire extending to the robot controller through the rigid elongated body 260 of the instrument 252.

The robot controller 114 controls minimally invasive surgical procedures within the body of subject 14 by controlling controllably manipulating the proximal end 254 of the surgical instrument 252 to provide control movement of the distal end 256. Can take on the role of doing what is possible. As schematically shown in FIG. 18, in one configuration, the robot controller 114 may include a motion controller 270, a position detection module 272, and a monitoring processor 274. The motion controller 270 has six or more degrees of freedom (eg, translation of three degrees of freedom, rotation of three degrees of freedom, and / or freedom) of multiple motors, linear actuators, or proximal ends 254 of surgical instruments 252. It may contain other components necessary to operate with one or more start-ups). In addition, the motion controller 270 may include one or more processors or digital computers and / or power electronics necessary to translate the received motion commands into physical activation of the motor or actuator.

The position detection module 272 may be configured, for example, to determine the position / motion of the distal end 256 of the surgical instrument 252 with respect to one or more external reference frames. May include. In one configuration, the position detection module 272 may monitor the behavior of the motion controller 270 to determine the motion of the distal end 256 using the kinematic relationship of the surgical instrument 252. In another configuration, the position detection module 272 utilizes, for example, a coded fitting / coupling device, ultrasonic energy, magnetic energy, or electromagnetic energy that can be propagated through subject 14, far away from the surgical instrument 252. A position signal 276 capable of clarifying the position of the position end portion 256 may be received from the external position determination device 106.

The monitoring processor 274 may be embodied as one or more digital computers or data processing units, each of which is one or more microprocessors or central processing units (CPUs), read-only memory (ROM), random access memory ( RAM), electrically erasable programmable read-only memory (EEPROM), high-speed clock, analog digital (A / D) circuit, digital-analog (D / A) circuit, input / output (I / O) circuit, power electronics / It has a transformer and / or signal conditioning and buffering electronics. Individual control routines / systems resident or easily accessible in the watch processor 274 are stored in ROM or other suitable tangible memory locations and / or memory devices and are automatically stored by the relevant hardware components of processor 274. Can be executed to provide each control function. In one embodiment, the monitoring processor 274 may provide a start command to the motion controller 270 in a closed loop fashion using the position feedback provided by the position detection module 272. The surveillance processor 274 may perform any combination of feedforward, feedback, and / or predictive control schemes to precisely control the movement and / or initiation of the distal end 256 of the surgical instrument 252.

In addition, the robot controller 114 may communicate with a master station 280 that includes a user input device 282 and a user feedback device such as a display 284 (eg, which may be similar to the display 112 provided in FIG. 6). .. The user input device 282 may receive an input 286 from the user corresponding to the intended movement of the distal end 256 of the surgical instrument 252. Next, the master station 280 may provide an operation command to the robot controller 114 corresponding to the received input 286. Similarly, the master station 280 can receive visual information 288 from the robot controller and convey this visual information to the user via the display 284.

FIG. 18 provides one embodiment of the robot controller 114, but other embodiments, configurations, and / or control schemes are similarly used to produce control and intended movement of the distal end 256. The surgical instrument 252 can be operated. The robot controller 114 and the surgical instrument 12 described above are of the type generally used for robotic laparoscopy, but such description is for illustrative purposes only and should not be limited. Other minimally invasive surgical systems that use the robot controller 114 to control the movement of the distal end of the elongated surgical instrument may include, for example, a robot catheter system and / or a robot endoscopy system.

Referring again to FIG. 17, the robotic surgical system 250 includes (and / or may communicate with) a neural surveillance system 10 capable of digitally communicating with the robot controller 114. As mentioned above, the neural monitoring system 10 can include at least one mechanical sensor 22 and a neural monitoring processor 20 that communicates with the mechanical sensor 22. The nerve monitoring system 10 may provide the robot controller 114 with a nerve recognition state that may be adjacent to the distal end 256 of the surgical instrument 252. In this way, the robot system 250 can avoid manipulation of tissues that can jeopardize neural integrity (via either translational movement or operation of the end effector 262).

If the nerve monitoring processor 20 detects the presence of a nerve in proximity to the elongated device 252 (via the mechanical sensor 22) (ie, via the mechanical sensor 22), the control signal 290 may be provided to the robot controller 114. good. The control signal 290 may include a relative position / orientation indication of the nerve, and may further include an indication of the proximity of the distal end 256 of the surgical instrument 252 to the nerve.

Upon receiving the control signal 290, the robot controller 114 may artificially constrain the movement of the distal end 256 of the surgical instrument 252 to avoid inadvertent contact with the proximal nerve. For example, in one configuration, the robot controller 114 may be configured to prevent all movement of the distal end 256 of the surgical instrument 252 in response to the received control signal 290. Therefore, when the distal end 256 is operating, the received control signal 290 can cause the controller 114 to stop the operation and wait for further commands from the user. In addition, the robot controller 114 may be configured to limit or prevent the operation of the end effector 262 when the control signal 290 is received. Conversely, in certain therapeutic procedures, the robot controller 114 is configured to activate the end effector 262 upon receipt of control signal 290 (eg, when selectively delivering excision energy to tissue close to the nerve). You may.

In another configuration, as schematically shown in FIG. 19, upon receiving the control signal 290, the robot controller can limit the ability of the device to move in the direction towards nerve 292. In yet another configuration, the robot controller 114 can build a virtual barrier 294 around the nerve 292 to prevent the instrument 252 from moving within a predetermined distance of the nerve 292. The virtual barrier 294 may be retained in the associated memory of the robot controller 114 and / or may be associated with a 3D neural model 100 that may be retained by the neural monitoring processor 20. In general, the virtual barrier 294 can limit the permissible range of motion of the surgical instrument 252 so as to artificially limit the surgical instrument 252 from crossing the virtual barrier 294. As schematically shown in FIG. 20, when the surgical instrument 252 moves and obtains additional neural orientation information, the virtual barrier 294 can be densified.

In yet another configuration, once the nerve is detected, the robot controller 114 dissects the surgical instrument 252 as a function of the indicated proximity between the real-time position of the instrument 252 and the estimated relative position of the nerve. It may be configured to vary the permissible speed of the end 256. Therefore, the instrument 252 may be able to move faster and / or at a faster speed when it is far from the nerve. In this way, the accuracy of movement can be improved as one or more nerves approach each other.

If the presence of a proximity nerve is detected and / or if the robot controller 114 performs an action that regulates or limits the permissible movement of the surgical instrument 252, the robot controller 114 will also contact the user via the master station 280. Alerts (ie, visual or auditory alerts) may be sent.

Although the above-mentioned technique mainly focuses on determining the position of the nerve with respect to the stimulator 30 and creating a nerve probability model, the nerve monitoring processor 20 is artificially operated by the system 10 from the reaction intended by the patient. Further may include one or more filtering algorithms that can distinguish between a mechanically evoked mechanical muscle response and / or an overall translation of a portion of the patient. Suitable filtering algorithms are analog filtering algorithms as described in US Pat. No. 8,343,079, the full text of which is incorporated herein by reference, and / or the full text of which is incorporated herein by reference, 2013. It may include a digital filtering algorithm as described in US Patent Application Publication No. 2015/0051506 "Neural Event Detection" filed August 13, 2015. These filtering algorithms result from the time correlation between the applied stimulus and the detected response, the rise time / gradient of the monitored response, and / or the stimulus provided by the detected mechanical muscle movement. It is possible to focus on the frequency characteristics of the monitored response that distinguishes whether or not. In one configuration, such filtering may precede any proximity detection and / or position triangulation.

Although the best embodiments for carrying out the present invention have been described in detail, those skilled in the art relating to the present invention will have various alternatives for carrying out the present invention within the scope of the appended claims. You will recognize the design and embodiments. It is intended that all matters contained in the above description or shown in the accompanying drawings should be construed as merely exemplary and not limiting.

The various features, uses, and advantages of the above techniques are further described in the following clauses.
Item 1: A method of modeling a nerve located in a patient's internal treatment area, in which the positions of electrodes are aligned with multiple positions in a virtual workspace, and each of the multiple positions is in the internal treatment area. Nerve-controlled muscles that correspond to different locations within, and that provide electrical stimulation from electrodes to internal tissues at different locations within the therapeutic area within the body, and for each of the provided electrical stimulation. Using the magnitude of the electrical stimulus provided at each location and the monitored response of the muscle to the stimulus provided to determine the distance from each of the different locations to the nerve. A method comprising constructing a virtual model of a nerve in a virtual workspace using the determined distance from each of the different positions to the nerve and multiple positions in the virtual workspace.

Item 2: Determining the distance to the nerve determines the minimum magnitude of the electrical stimulus required to elicit a muscle response, and determines the distance from the determined minimum magnitude to the nerve. The method according to paragraph 1, comprising determining.

Section 3: Merging the neural model with an anatomical image representing the area of treatment in the body and displaying the merged neural model and anatomical image on a display, further provided in Section 1. The method described.

4. The method of paragraph 3, wherein the anatomical image comprises a 3D anatomical model.

5. The method of paragraph 3, wherein the anatomical image comprises a real-time 2D image.

Item 6: Merging the neural model with an anatomical model representing the therapeutic area in the body and identifying the anatomical target within the anatomical model, where the anatomical model is anatomical. Determining the inclusion of at least one blocking structure between the outer surface of the model and the anatomical target and determining the shortest path from the outer surface to the anatomical target to avoid contact with nerves and blocking structures. The method of paragraph 1, further comprising providing the route provided to the display or robot controller.

Item 7. The method according to item 6, wherein the shortest path is non-linear.

Item 8: Providing a virtual model of a nerve to a robot controller, wherein the robot controller can operate to control the movement of an end effector disposed in an in-vivo treatment area. The method of paragraph 1, further comprising constraining the motion of the end effector via a robotic controller according to a virtualized model.

9. The method of paragraph 1, wherein monitoring the muscle response comprises sensing the mechanical response of the muscle using a non-invasive mechanical sensor.

Item 10. Building a virtual model of the nerve can be a spatial arrangement of at least two of the multiple positions and a determined distance from the corresponding position within the therapeutic area of the body for each of the at least two positions to the nerve. The method according to paragraph 1, comprising triangulating the position of the nerve using and.

Item 11: Building a virtual model of a nerve creates a 3D shell around each of multiple positions in the virtual workspace at a distance equal to the determined distance from the corresponding position in the internal processing area to the nerve. The method of paragraph 1, comprising triangulating the position of the nerve by filtering the virtual workspace to identify areas with shell densities above a predetermined threshold.

Section 12, further comprising identifying a portion of the virtual workspace as non-nervous in the absence of a muscle response to one or more of a plurality of electrical stimuli. Method.

13. The method of paragraph 12, further comprising identifying a portion of the virtual workspace that is less than the determined distance from each of the plurality of locations as non-nervous.

Item 14. The method according to item 1, wherein the electrodes are a plurality of electrodes.

Item 15. A method of modeling a patient's internal therapeutic area with respect to the presence of nerves, monitoring the location of one or more electrodes within the internal therapeutic area and the internal therapeutic area via one or more electrodes. Is to provide multiple electrical stimuli to each of the different locations within the therapeutic area of the body, and to control the nerves about the response to each of the multiple electrical stimuli. From the monitoring of the muscle being performed and the monitored response of the muscle to the electrical stimulus provided, the magnitude of the electrical stimulus provided at at least one of the different locations, and the location different from the nerve. Determining the distance to at least one, the first portion representing the nerve at the distance determined from at least one of the different locations, and the second representing the space within the therapeutic area that does not contain the nerve. A method of constructing a virtual model of an in-vivo therapeutic area, including parts of the body.

Item 16: Determining the distance between a nerve and at least one of different locations is the minimum necessary to elicit a muscle response when provided at at least one of the different locations. 13. The method of paragraph 15, comprising determining the magnitude of the electrical stimulus and determining the distance between the nerve and at least one of the different locations from the determined minimum magnitude. ..

Clause 17: Merging the virtual model with an anatomical image representing the area of treatment in the body, wherein the anatomical image comprises a 3D anatomical model or a 2D image, and the merged virtual model and 15. The method of paragraph 15, further comprising displaying an anatomical image on a display.

Section 18: Merging a virtual model with an anatomical model that represents an area of treatment within the body and identifying an anatomical target within the anatomical model, where the anatomical model is anatomical. Determine the shortest path from the outer surface to the anatomical target, including at least one blocking structure between the outer surface of the model and the anatomical target, and avoiding the portion of the virtual model representing the nerve and the blocking structure. 15. The method of paragraph 15, further comprising: and providing the determined path to the display or robot controller.

Item 19: Providing a virtual model to a robot controller that can operate to control the movement of the end effector disposed in the treatment area of the body, and using the provided virtual model to perform the movement of the end effector. 15. The method of paragraph 15, further comprising binding.

20: The method of paragraph 15, wherein monitoring the muscle response comprises sensing the mechanical response of the muscle using a non-invasive mechanical sensor.

Item 21: A method of modeling a nerve, in which a plurality of electrical stimuli are provided from one or more electrodes to a treatment area in a patient's body, and each of the plurality of electrical stimuli has a magnitude of electric current. It is provided at different locations within the body's therapeutic area, and non-invasive mechanical sensors are used to monitor the mechanical response of the muscle to each of multiple electrical stimuli, and multiple provided electricity. The magnitude of each current of the stimulus and the mechanical response of the monitored muscles are used to determine the distance between each of the nerves and each of the different positions, and of each of the nerves and each of the different positions. A method that includes building a virtual model of a nerve within a virtual workspace using the determined distance between them.

Item 22: Determining the distance between the nerve and each of the different positions determines the amount of minimum current required to elicit a muscle response when provided to each of the different positions. 21. The method of paragraph 21, comprising determining and determining the distance between the nerve and at least one of the different positions from the determined minimum size.

Item 23: The monitored response to at least one of the plurality of electrical stimuli is unresponsive, or the portion of the virtual workspace is the determined distance from one or more of the different locations. 21. The method of paragraph 21, further comprising identifying a portion of the virtual workspace as non-nervous, based on being smaller than and at least one of them.

Item 24: Building a virtual model of the nerve is to align each of the different positions in the virtual workspace and to each of the different positions around each of the different positions in the virtual workspace. By creating a 3D shell at a distance equal to the determined distance from the nerve to the nerve, and by filtering the virtual workspace to identify areas with shell densities above a given threshold, the location of the nerve can be determined. 21. The method of paragraph 21, comprising triangulation.

Item 25: Providing a virtual model to a robot controller that can operate to control the movement of the end effector disposed in the internal treatment area, and constraining the movement of the end effector using the provided virtual model. 21. The method of paragraph 21, further comprising:

Item 26: Multiple electrodes disposed at the distal end of one or more elongated medical devices, each of which is a neural mapping system configured to extend within the subject's body treatment area. It comprises a sensor configured to provide an output signal corresponding to the monitored muscle response, each of the plurality of electrodes and a processor that communicates with the sensor, wherein the processor is a plurality of electrodes within the therapeutic area of the body. An electrical stimulus is provided to each electrode so that it receives the reading at each position and the stimulus can be transmitted to the body tissue at each of the multiple positions, and the reading of the magnitude of the muscle response monitored by the sensor. The response of the muscle is evoked by the provided electrical stimulus, and the magnitude of the provided electrical stimulus and the monitored response of the muscle to the provided stimulus are used from the respective positions of multiple electrodes. A nerve mapping system configured to determine the distance to a nerve and build a virtual model of the nerve using the determined distance to the nerve at each of multiple positions.

Item 27: Distance to nerve by the processor determining the magnitude of the minimum electrical stimulus required to elicit a muscle response and determining the distance from the determined minimum magnitude to the nerve. 26. The system according to paragraph 26, which is configured to determine.

28: The processor is further configured to merge the neural model with an anatomical image representing the therapeutic area in the body and display the merged neural model and anatomical image on the display. The system described in.

29: The system according to 28, wherein the anatomical image comprises a 3D anatomical model.

30: The system according to 28, wherein the anatomical image comprises a real-time 2D image.

Clause 31: Further configured to provide a robotic controller capable of operating to control the movement of end effectors disposed within the in-vivo treatment area, the processor is further configured to provide a virtual model of the nerve to the robotic controller. 26. The system of paragraph 26, wherein the robot controller is configured to constrain the motion of the end effector using the provided virtual model.

32: The system of paragraph 26, wherein the sensor is a non-invasive mechanical sensor and the output signal corresponds to the mechanical response of the muscle.

Item 33: The processor triangulates the position of the nerve using the position of at least two of the electrodes and the indicated distance reading from at least two of the electrodes to the nerve. 26. The system according to paragraph 26, which is configured to construct a virtual model of the nerve by.

Item 34: The processor is configured to construct a virtual model of the nerve by triangulating the position of the nerve, and triangulating the position of the nerve is the position of each of the multiple electrodes within the therapeutic area of the body. Aligns the respective positions of multiple electrodes within the corresponding virtual workspace and determines for each position around each of the multiple positions within the virtual workspace using the received readings of. 26, comprising creating a 3D shell at a distance equal to the distance to the nerve, and filtering the virtual workspace to identify areas with shell densities above a predetermined threshold. System.

Item 35: If the virtual model is built by the processor in the virtual workspace and the processor is less than the threshold magnitude of the monitored response of the muscle, then the portion of the virtual workspace is nerve-free. 26. The system according to paragraph 26, which is further configured to identify as.

Item 36: The processor is further configured to identify a portion of the virtual workspace that is less than the determined distance from each of the nerve-free electrodes as non-nerve. The system described in the section.

Item 37: The processor provides a first electrical stimulus at a first location within the treatment area of the body, and the first electrical stimulus does not elicit a threshold response in the nerve-controlled muscle of the first current. It has a magnitude and provides a second electrical stimulus at a second location within the therapeutic area of the body, the second electrical stimulus has a magnitude of the first current and a muscle response greater than the threshold. Trigger and provide one or more additional electrical stimuli in the second position, each with one or more current magnitudes smaller than the first current magnitude. From the additional electrical stimulation of the 26. The system of paragraph 26, which is configured to use the current to determine the distance from the second position to the nerve.

Item 38: A virtual model of a nerve is located in a virtual workspace, and a processor aligns each of the first and second positions in the virtual workspace and surrounds the first position. Section 37, further configured to show a portion of the workspace as non-nerve and to build a virtual model of the nerve within the workspace at a determined distance from a second position. System.

Clause 39: The processor is further configured to receive the readings of the anatomical target within the therapeutic area of the body and use a neural model to determine the route of entry to the anatomical target. 26. The system according to paragraph 26, which minimizes the possibility of contact with the modeled nerve.

Item 40: A neural mapping system, monitored with one or more electrodes placed at the distal end of an elongated medical device, each configured to extend within the subject's internal therapeutic area. It comprises a sensor configured to provide an output signal corresponding to the muscle response and a processor that communicates with each of one or more electrodes and the processor, where the stimulus is located at multiple locations within the therapeutic area of the body. Each of one or more electrodes provides an electrical stimulus so that each of them can be transmitted to internal tissues, each stimulus has a magnitude of current, receives an output signal from a sensor, and has multiple output signals. Provides an indication of the muscle's response to the electrical stimuli provided at each of the locations, and provides a virtual model of the therapeutic area in the body from the magnitude of the electrical stimuli provided at each of the multiple locations and the output signal received. A neural mapping system constructed and configured such that a virtual model contains a first part that represents the nerves that innervate the muscle and a second part that represents the space within the internal therapeutic area that does not contain nerves. ..

Item 41: The processor receives the reading of the anatomical target within the in-vivo treatment area and enters the anatomical target using a virtual model of the in-vivo treatment area that extends only through the second part of the model. 40. The system of paragraph 40, further configured to determine a route.

42: The system of paragraph 41, further comprising a robotic controller configured to constrain the movement of a tool extending within the treatment area within the body with respect to the determined approach path.

Item 43: The processor is further configured to merge the anatomical model with a virtual model of the area of treatment in the body, where the anatomical model is a block containing at least part of the bone, intestine, liver, or kidney. 41. The system according to paragraph 41, wherein the system has a non-blocking portion that does not contain any of bone, intestine, liver, or kidney, and the entry route extends only through the non-blocking portion.

44: The system of paragraph 41, wherein the approach path is non-linear.

Item 45: The processor monitors the position of the tool with respect to the determined approach path, displays a first indicator if the tool is within a predetermined tolerance of the approach path, and the tool has a predetermined tolerance from the approach path. 41. The system of paragraph 41, further configured to display a second indicator if greater than the error.

Item 46: A method for determining the position of a nerve in an internal space, in which the distal end of the stimulator is advanced toward an anatomical target in the internal space, and the stimulator becomes an anatomical target. While advancing toward, the first electrical stimulus is periodically applied from the first electrode disposed on the central axis of the stimulator, and the nerve in the body space to the first electrical stimulus. Detecting the response of the muscle dominated by, and after detecting the response of the muscle to the first electrical stimulus, applying the position determination electrical stimulus from multiple positions offset from the central axis of the stimulator. Monitoring the magnitude of the muscle response to the position determination electrical stimulus at each of the multiple positions, the magnitude of the muscle response to the position determination electrical stimulus at each of the multiple positions, and provided for each of the multiple positions. Position determination The nerve position is determined by determining the distance between the nerve and each of the multiple positions from the magnitude of the electrical stimulus, and by triangulating the position from the determined distance at each of the multiple positions. And how to include.

Clause 47: Further includes rotating the stimulator such that the offset electrode rotates through each of the plurality of positions, and applying the position determination electrical stimulus includes applying the stimulus from the offset electrode. , The method according to paragraph 46.

Item 48: Determining the distance between a nerve and each of a plurality of positions determines the magnitude of the minimum electrical stimulus required to elicit a muscle response at each of the multiple positions. 46. The method of claim 46, comprising: determining the distance to the nerve at each of the plurality of positions from the determined minimum magnitude at each position.

49: The method of paragraph 46, further comprising displaying the relative direction between the stimulator and the triangulation position of the nerve.

Item 50: Monitoring the location of the stimulator within the treatment area of the body and maintaining a virtual model of the nerve within the virtual workspace using the triangulation position of the nerve and the position of the monitored stimulator. , A method according to paragraph 46, further comprising.

51: The method of claim 50, further comprising identifying a portion of the virtual workspace as non-nerve in response to an applied first electrical stimulus.

52: The method of claim 46, wherein the magnitude of the position determination electrical stimulus at each of the plurality of positions is smaller than the magnitude of the first stimulus.

53: The method of paragraph 46, further comprising preventing the stimulator from advancing towards the triangulation position of the nerve.

Item 54: The muscle is the first muscle and the nerve is the first nerve, and this method monitors the magnitude of the response of the second muscle to the position determination electrical stimulus at each of the multiple positions. And, from the magnitude of the response of the second muscle to the position determination electrical stimulus at each of the plurality of positions and the magnitude of the position determination electrical stimulus provided at each of the plurality of positions, the second nerve and the plurality of positions Further including determining the distance between each and determining the position of the second nerve by triangulating the position of the second nerve from the determined distances at each of the plurality of positions. , The method according to paragraph 46.

Item 55: Comparing the magnitude of the first electrical stimulus with the threshold after the detected response of the muscle to the first electrical stimulus and only if the magnitude of the first electrical stimulus is below the threshold. 46. The method of claim 46, further comprising applying a position determination electrical stimulus.

56: The method of paragraph 55, further comprising reducing the magnitude of the first electrical stimulus when the magnitude of the first electrical stimulus exceeds a threshold.

Item 57: Monitoring the position of the distal end of the stimulator, estimating the distance between the monitored position and the nerve, and comparing the estimated distance to the threshold distance, estimation. 46. The method of paragraph 46, further comprising selecting the magnitude of the first electrical stimulus so as not to elicit a muscle response if the distance is greater than the threshold distance.

Item 58: A method for determining the position of a nerve in an internal space, in which the distal end of the stimulator is advanced toward an anatomical target in the internal space, and the stimulator becomes an anatomical target. While advancing toward, the first electrical stimulus is periodically applied from the first electrode disposed on the central axis of the stimulator, and the nerve in the body space to the first electrical stimulus. Detecting the response of the muscle dominated by, and after detecting the response of the muscle to the first electrical stimulus, applying the position determination electrical stimulus from multiple positions offset from the central axis of the stimulator. Monitoring the magnitude of the muscle response to the positioning electrical stimulus at each of the multiple locations and determining the minimum electrical stimulation required to elicit the muscle response at each of the multiple locations. And, a method including determining the position of a nerve by triangulating the position of the nerve from the magnitude of the determined minimum electrical stimulus at each of the plurality of positions.

Item 59: Further comprising rotating the stimulator such that the offset electrode rotates through each of the plurality of positions, and applying the position determination electrical stimulus includes applying the stimulus from the offset electrode. , 58.

60: The method of 58, further comprising displaying the relative direction between the stimulator and the triad of nerves.

Item 61: Triangulation of the nerve position from the determined minimum electrical stimulus magnitude at each of the multiple positions is possible from the determined minimum magnitude at each of the multiple positions. This method involves monitoring the position of the stimulator within the therapeutic area of the body and using the triangulation position of the nerve and the position of the monitored stimulator, including determining the distance between each of the positions. 58. The method of paragraph 58, further comprising maintaining a virtual model of nerves within a virtual workspace.

62: The method of claim 58, wherein the magnitude of the position determination electrical stimulus at each of the plurality of positions is smaller than the magnitude of the first stimulus.

Item 63: Comparing the magnitude of the first electrical stimulus with the threshold after the detected response of the muscle to the first electrical stimulus and only if the magnitude of the first electrical stimulus is below the threshold. 58. The method of claim 58, further comprising applying a position determination electrical stimulus.

64: The method of paragraph 63, further comprising reducing the magnitude of the first electrical stimulus when the magnitude of the first electrical stimulus exceeds a threshold.

Item 65: Monitoring the position of the distal end of the stimulator, estimating the distance between the monitored position and the nerve, comparing the estimated distance with the threshold distance, and estimating. 58. The method of claim 58, further comprising selecting the magnitude of the first electrical stimulus so as not to elicit a muscle response if the distance is greater than the threshold distance.

[Implementation mode]
(1) A method for determining the position of a nerve in a subject's internal treatment area.
By providing a first electrical stimulus at a first location within the body therapeutic area, the first electrical stimulus does not elicit a threshold response of the nerve-controlled muscle of a first current. It has a size and
The provision of a second electrical stimulus at a second position within the body treatment area, wherein the second electrical stimulus has the magnitude of the first current and is greater than the threshold. To induce the reaction of
By providing one or more additional electrical stimuli at the second position, each of the one or more additional stimuli has a current magnitude smaller than the first current magnitude. That and
From the one or more additional electrical stimuli, determining the magnitude of the minimum current required to elicit the threshold response of the muscle at the second position.
Using the determined minimum current magnitude to determine the distance from the second position to the nerve,
Including, how.
(2) The method of embodiment 1, further comprising monitoring the muscle response to each of the first, second, and one or more additional electrical stimuli using a non-invasive mechanical sensor. ..
(3) Each of the first, second, and one or more additional electrical stimuli is provided from the distal end of the elongated stimulator.
The first and second electrical stimuli are provided by electrodes disposed on the central axis of the stimulator.
The method of embodiment 1, wherein the one or more additional electrical stimuli are provided from an offset electrode away from the central axis of the stimulator.
(4) Further comprising rotating the offset electrode over a plurality of angular positions about the central axis of the stimulator.
Determining the distance from the second position to the nerve includes determining the distance from each of the plurality of angular positions to the nerve.
Further comprising triangulating the position of the nerve with respect to the central axis of the stimulator using the determined distance from each of the plurality of angular positions.
The method according to the third embodiment.
(5) The first electrical stimulus is provided by an electrode disposed at the distal end of the stimulator.
The above method
Monitoring the position of the distal end of the stimulator and
Using a pre-acquired anatomical model, the estimated distance between the monitored position and the nerve can be estimated.
Using the estimated distance to select the magnitude of the first current,
The method according to embodiment 1, further comprising.

(6) The magnitude of the first current is selected from the bounded current range and is the maximum within the range that is not expected to elicit the muscle response when applied at the estimated distance from the nerve. The method according to embodiment 5, which is an electric current.
(7) The method of embodiment 6, further comprising adjusting the anatomical model when the magnitude of the selected current evokes the muscle response.
(8) The method according to embodiment 5, wherein the anatomical model is an acquired model of the subject.
(9) Aligning each of the first position and the second position in the virtual workspace,
The portion of the virtual workspace surrounding the first position is shown as not containing the nerve.
The method according to embodiment 1, further comprising.
(10) The method of embodiment 9, further comprising showing the presence of nerves in the workspace at the determined distance from the second position.

(11) Further comprising showing the second portion of the virtual workspace as non-nerve, wherein the second portion surrounds the second position up to the determined distance. The method according to aspect 10.
(12) To provide the virtual workspace to a robot controller capable of operating to control the movement of an end effector disposed in the in-vivo treatment area.
The robot controller to limit the movement of the end effector according to at least one of the nerve-free portion of the workspace and the presence of the nerve indicated in the workspace. To restrain and
10. The method of embodiment 10, further comprising.
(13) A method for determining the position of nerves in a subject's internal therapeutic area.
A first electrical stimulus with a magnitude of a first current is applied at a first position within the treatment area of the body, wherein the first position is greater than a threshold distance from the nerve. The threshold distance is the maximum distance at which the first electrical stimulus can induce a threshold response of the nerve-controlled muscle.
A second electrical stimulus with a magnitude of a second current is applied at a second position within the treatment area within the body, wherein the second position is less than the threshold distance from the nerve. The magnitude of the second current is smaller than the magnitude of the first current.
To monitor the magnitude of the response of the nerve-controlled muscle to the second electrical stimulus,
Determining the distance from the second position to the nerve from the magnitude of the second current and the magnitude of the monitored reaction of the muscle.
Aligning each of the first position and the second position in the virtual workspace,
The portion of the virtual workspace surrounding the first position is shown as not containing the nerve.
To indicate the presence of a nerve in the virtual workspace at the determined distance from the second position.
Including, how.
(14) The method according to embodiment 13, wherein the magnitude of the second current is the magnitude of the minimum current required to elicit the reaction of the muscle at the second position.
(15) The first and second electrical stimuli are applied by electrodes arranged in the in-vivo treatment area, respectively.
13. The method of embodiment 13, wherein the method further comprises advancing the electrode from the first position to the second position.

(16) The implementation further comprises showing the second portion of the virtual workspace as non-nervous, wherein the second portion surrounds the second position up to the determined distance. The method according to aspect 13.
(17) The first electrical stimulus is provided by an electrode disposed on the distal end of the stimulator.
The above method
Monitoring the position of the distal end of the stimulator and
Using a pre-acquired anatomical model, the estimated distance between the monitored position and the nerve can be estimated.
Using the estimated distance to select the magnitude of the first current,
The method according to embodiment 13, further comprising.
(18) The magnitude of the first current is selected from the bounded current range and is the maximum within the range that is not expected to elicit the muscle response when applied at the estimated distance from the nerve. 17. The method of embodiment 17, which is an electric current.
(19) The method of embodiment 18, further comprising adjusting the anatomical model, where the magnitude of the selected current evokes the muscle response.
(20) To provide the virtual workspace to a robot controller capable of operating to control the movement of an end effector disposed in the in-vivo treatment area.
The robot controller is configured to limit the movement of the end effector according to at least one of the nerve-free portion of the workspace and the presence of the nerves shown in the workspace. Restraining and
The method according to embodiment 13, further comprising.

Claims (9)

It ’s a neural mapping system.
An elongated medical device comprising a distal end configured to explore a subject's body treatment area, wherein the distal end comprises an electrode.
With non-invasive mechanical sensors configured to provide mechanomyogram output signals corresponding to the monitored mechanical response of nerve-controlled muscles,
The processor comprises a processor that communicates with the electrode and the non-invasive machine sensor.
Providing a plurality of electrical stimuli to the electrodes, each of the plurality of electrical stimuli having a magnitude of each, the electrodes at different positions within the subject's internal therapeutic area. When positioned, each of the multiple electrical stimuli is provided, and
To detect the reaction of the muscle to each of the plurality of electrical stimuli via the mechanomyogram output signal, and
Using the respective magnitudes of each of the plurality of electrical stimuli and the detected response of the muscle to each of the plurality of electrical stimuli, the nerve may be present at a particular point within the therapeutic area within the body. Is configured to determine and do
The plurality of electrical stimuli are
A first electrical stimulus provided when the electrode is in a first position within the therapeutic area of the body, wherein the first electrical stimulus does not elicit a threshold mechanical response of the muscle. The first electrical stimulus, which has the magnitude of the electric current,
A second electrical stimulus provided when the electrode is in a second position within the in-vivo treatment area, wherein the second electrical stimulus has the magnitude of the first current. Electrical stimulation and
One or more additional electrical stimuli provided when the electrode is in the second position, each of which is less than the magnitude of the first current. A neural mapping system, including one or more additional electrical stimuli, having a size of . Further equipped with a position determination device that can operate to detect the position of the electrode inside the treatment area in the body.
The processor is communicating with the position determination device and further uses the detected position of the electrode when each of the plurality of electrical stimuli is provided to a specific point within the treatment area within the body. The nerve mapping system according to claim 1, wherein the nerve mapping system can operate to determine the possibility that a nerve is present. At least one of a non-contact positioning device or a multi-axis spatial input device in which the position determining device utilizes ultrasonic waves, an electric field, a magnetic field, or a fluorescence fluoroscopy method to determine the position of the electrode in a three-dimensional space. The neural mapping system according to claim 2, comprising one. The processor is configured to maintain a virtual workspace containing a plurality of three-dimensional boxels, wherein the virtual workspace represents the subject's internal treatment area.
The processor
To align the position of the electrode within the virtual workspace when each of the plurality of electrical stimuli is provided.
The distance between the electrode and the nerve at each position using the magnitude of the electrical stimulus provided at that location and the detected response of the muscle to the electrical stimulus provided at that location. To judge and
Incrementing the counter associated with each voxel, which is the distance determined from the aligned position,
To reset the counter associated with each voxel that is less than the determined distance from the aligned position.
Filtering all voxels of counters below a given threshold to generate a neural model,
The nerve mapping system according to claim 1, wherein the nerve mapping system is configured to determine the possibility that a nerve is present at a specific point inside the treatment area in the body. The neural mapping system of claim 4, wherein the processor is further configured to merge the neural model with CT, MRI, fluorescence fluoroscopy, or ultrasound images. Further equipped with a positioning device capable of operating to monitor the position of the distal end of the elongated medical device.
The processor
Using a pre-acquired anatomical model, the estimated distance between the monitored position and the nerve can be estimated.
Using the estimated distance to select the magnitude of the first current,
From the one or more additional electrical stimuli, determining the magnitude of the minimum current required to elicit the threshold mechanical response of the muscle at the second position.
Using the determined minimum current magnitude to determine the distance from the second position to the nerve,
The neural mapping system according to claim 1 , further configured to perform the above. The bounded current range in which the magnitude of the first current is selected from the bounded current range and is not expected to elicit the mechanical response of the muscle when applied at the estimated distance from the nerve. The neural mapping system according to claim 6 , which is the maximum current in the range. The neural mapping system according to claim 1, wherein each of the electrical stimuli provided to the electrodes is transmitted omnidirectionally to the treatment area in the body. The elongated medical device comprises a central axis that intersects the distal end and extends through the center of the elongated medical device.
The electrode is a first electrode disposed on the central axis at a first position at the end of the elongated medical device.
Further comprising at least one second electrode away from the first electrode and radially offset from the central axis at the second position.
At least one of the plurality of electrical stimuli is provided to the first electrode, and at least one of the plurality of electrical stimuli is provided to the at least one second electrode. The neural mapping system according to claim 1.

Images