Method and system for surgical navigation using spatial registration of tissue fluorescence during an excision procedure

Abstract

A neurosurgical method for determining the resection status of a tumor is described. The method includes obtaining a medical image of a human organ that includes a segmented tumor. The method further includes determining the pose of a suction instrument that includes at least one optical fiber and a navigation tracker. The method further includes generating excitation light for at least one optical fiber to excite a target region that includes the tumor and a margin region surrounding the tumor. The method further includes receiving collected fluorescence emitted from the target region. The method further includes determining whether the tissue within the target region corresponds to the tumor based on the fluorescence collected in the pose of the suction instrument. The method further includes displaying the resection status of the target region with respect to the medical image.

Description

Technical Field

[0001] Related Applications The present applicant claims the benefit of and all priority rights to U.S. Provisional Patent Application No. 63 / 364,695, filed May 13, 2022, the entire contents of which are incorporated herein by reference.

Background Art

[0002] Glioma tumors can occur in the glial cells of the brain or spine. Surgical procedures, more specifically tumor resection, are often performed to remove the tumor. The goal of the surgical procedure for tumor resection is to achieve gross total resection (GTR). A very aggressive form of glioma is glioblastoma. In glioblastoma patients, GTR has been shown to extend the patient's lifespan. For example, one study showed survival of 16 months after resection for GTR patients, but only 10 months after resection for patients with only 60% of the tumor removed, resulting in a 60% difference in the increase in survival months after resection.

[0003] Before the resection procedure, preoperative images of the patient can be acquired by a magnetic resonance imaging (MRI) system. The preoperative images can be used by medical professionals to plan the resection procedure. However, during the resection procedure, brain shift (i.e., deformation of the brain) may occur. Brain shift can be caused by a variety of factors such as resection of tumorous tissue or craniotomy, gravity, head position, drainage, brain tissue expansion, tissue manipulation, tissue size, and changes in intracranial pressure. In some instances, intraoperative magnetic resonance imaging (iMRI) can be acquired at the start of the resection procedure to account for brain shift that occurs after craniotomy has been performed. By acquiring iMRI, brain shift caused by craniotomy can be captured and accounted for. Subsequent intraoperative iMRI can be acquired throughout the procedure, such as after a medical professional has completed a portion of the resection procedure to ensure that no further brain shift has occurred during resection of the tumorous tissue, and after the medical professional has completed the resection procedure to confirm that the medical professional has achieved gross total resection (GTR). However, iMRI systems can be very costly, acquiring each MRI can take 30 minutes to 1 hour, and capturing multiple iMRIs during the resection procedure can be burdensome. Instead of performing iMRI, ultrasonic images can be captured from the tumorous tissue and later associated with the preoperative images to account for brain shift. Such an ultrasonic system can be useful for accounting for brain shift, but does not provide any other useful information such as information related to the biochemical / cellular information of the tumorous tissue.

[0004] In patients with severe gliomas, fluorescence-guided surgery can be used. Fluorescence-guided surgery improves the chance of achieving GTR. In many cases, 5-aminolevulinic acid (5-ALA) is administered to the patient several hours before the surgery. 5-ALA is a compound that occurs naturally in the hemoglobin synthesis pathway. In cancer cells, hemoglobin synthesis is inhibited and the pathway stalls at an intermediate compound called protoporphyrin IX (PpIX). During the surgery, medical specialists can illuminate areas of the brain tissue with excitation light (i.e., blue light) from a surgical microscope. The surgery may be performed in a dark or dimly lit operating room environment. Severe tumor cells containing PpIX absorb the excitation light and emit fluorescence with specific optical properties (i.e., red fluorescence). The fluorescence can be seen by medical specialists using a surgical microscope.

[0005] Fluorescence-guided surgery increases the likelihood of GTR in severe tumors with tumors such as glioblastoma. Currently, GTR for mild tumors is relatively low because it is difficult to find the margins. Tumor cells emit only low levels of fluorescence, and even using a surgical microscope, the human eye does not have sufficient sensitivity to detect such low levels of fluorescence, so 5-ALA cannot be used to improve the results of mild tumor resection. The various fluorescences emitted by cells associated with specific parts of the brain provide rich biochemical / cellular information about the cells of the tumorous tissue. However, current systems do not relate the collected fluorescence to the MRI images displayed on the surgical navigation display. Therefore, there is a need for a system and method for relating the level of fluorescence to MRI images in order to account for brain displacement, confirm GTR, and provide biochemical / cellular information about the cells associated with the tumorous tissue.

[0006] The description of the background art provided in this specification is generally for the purpose of presentation in the context of the present disclosure. The work of the inventors is not to be taken as an admission, expressly or impliedly, of prior art to the present disclosure, either as described in this background art section or as aspects of this specification that may not qualify as prior art at the time of filing.

Summary of the Invention

[0007] In one aspect, a neurosurgical method for determining the resection status of a tumor during a resection procedure is described. The method includes obtaining at least one medical image of a human organ, including the segmented tumor. The method includes determining the pose of a suction instrument, including at least one optical fiber and a navigation tracker, based on the navigation tracker. The method includes generating excitation light of the at least one optical fiber to excite a target region of the human organ. The target region includes the tumor and a margin region surrounding the tumor. The method includes receiving collected fluorescence emitted from the target region from the at least one optical fiber. The method includes determining, based on the collected fluorescence and at the pose of the suction instrument, whether the tissue within the target region corresponds to the tumor. The method includes displaying the resection status of the target region with respect to the at least one medical image based on the determination of whether the tissue corresponds to the tumor and the pose of the suction instrument.

[0008] In one aspect, a neurosurgical system for determining the resection status of neoplastic tissue in a target region is described. The neurosurgical system includes a suction device, a navigation tracker, an optical fiber, an excitation source, an optical instrument, and a surgical navigation system. The suction device is configured to apply suction to the patient's brain tissue. The suction device includes a suction cannula that defines a lumen. The navigation tracker is coupled to the suction device. The optical fiber is coupled to the suction cannula. The optical fiber is configured to transmit fluorescence emitted by the brain tissue. The excitation source is configured to emit excitation light having a wavelength that induces fluorescence of the neoplastic tissue. The optical instrument is coupled to the optical fiber. The optical instrument is configured to convert the fluorescence emitted by the brain tissue and transmitted by the optical fiber into an electrical signal. The surgical navigation system is configured to receive at least one medical image of a human organ including a segmented tumor. The surgical navigation system is also configured to determine the pose of the suction device based on the navigation tracker. The surgical navigation system is also configured to determine whether the tissue within the target region corresponds to neoplastic tissue based on the collected fluorescence at the pose of the suction device. The surgical navigation system is also configured to display at least one indicator regarding the at least one medical image based on the determination of whether the tissue within the target region corresponds to neoplastic tissue and the pose of the suction device.

[0009] In one aspect, a neurosurgical method for determining the resection status of a tumor from a human organ during a resection procedure is described. The neurosurgical method includes navigating a suction instrument, which includes a navigation tracker, within a human organ to a target region corresponding to a segmented tumor of at least one medical image. The method includes determining the pose of the suction instrument based on the navigation tracker. The method includes applying excitation light to the target region using an optical fiber coupled to the suction instrument, the optical fiber being connected to an excitation source. The method includes removing tissue from the target region using the suction instrument while collecting fluorescence from the target region using an optical fiber coupled to an optical device, the target region including tumorous tissue and a margin region surrounding the tumorous tissue. The method includes observing at least one virtual indicator superimposed on at least one medical image of a human organ including the segmented target region, based on the pose of the suction instrument, in response to a surgical navigation system connected to the optical device determining that the tissue corresponds to the tumor. The method includes comparing the at least one virtual indicator with the shape of the segmented target region to determine whether residual tumor remains.

[0010] In one aspect, a neurosurgical method for determining the extent of a neoplastic substance removed from a human organ is described. The neurosurgical method includes obtaining at least one medical image of a human organ that includes a segmented tumor. The method includes navigating a surgical instrument that includes a navigation tracker and at least one optical fiber within the human organ to a target region corresponding to the segmented tumor of the at least one image. The method includes determining the pose of the surgical instrument based on the navigation tracker. The method includes determining whether the tissue of the target region is neoplastic or not at the determined pose of the surgical instrument based on fluorescence emitted from the tissue. The method includes using a surgical navigation system to display (i) a first indicator superimposed on at least one medical image of the human organ based on the pose of the surgical instrument in response to a step of determining that the tissue is neoplastic, and (ii) a second indicator superimposed on at least one medical image of the human organ based on the pose of the surgical instrument in response to a step of determining that the tissue is not neoplastic.

[0011] In one aspect, a neurosurgical system for determining the extent of a neoplastic substance removed from a human organ is described. The neurosurgical system includes a surgical instrument, an optical system, and a surgical navigation system. The surgical instrument system includes a surgical instrument having a navigation tracker disposed thereon. The surgical instrument is configured to remove tissue from a target region of a human organ. The optical system includes at least one optical fiber, the at least one optical fiber being coupled to the surgical instrument and configured to illuminate the target region with excitation light and collect fluorescence emitted from the target region. The optical system is configured to convert the fluorescence into an electrical signal. The surgical navigation system is configured to receive at least one medical image of a human organ including a segmented tumor. The surgical navigation system is configured to determine the pose of the surgical instrument based on the navigation tracker. The surgical navigation system is configured to determine whether the tissue in the target region is neoplastic or not based on the electrical signal at the determined pose of the surgical instrument. The surgical navigation system is configured to display (i) a first indicator superimposed on at least one medical image of the human organ based on the pose of the surgical instrument in response to a determination that the tissue is neoplastic, and (ii) a second indicator superimposed on at least one medical image of the human organ based on the pose of the surgical instrument in response to a determination that the tissue is not neoplastic.

[0012] In one aspect, a neurosurgical method for determining the resection status of a tumor during a resection procedure is described. The method includes obtaining at least one medical image of a human organ, including the segmented tumor. The method includes determining the pose of a suction instrument, including at least one optical fiber and a navigation tracker, based on the navigation tracker. The method includes generating excitation light for at least one optical fiber to excite a target region of the human organ, the target region including the tumor and a margin region surrounding the tumor. The method includes receiving collected fluorescence emitted from the target region from at least one optical fiber. The method includes determining the intensity of the collected fluorescence. The method includes generating a point cloud based on the intensity of the collected fluorescence and the pose of the suction instrument.

[0013] Further areas of applicability of the present disclosure will become apparent from the detailed description, the claims, and the drawings herein. The detailed description and specific examples are intended for illustration only and are not intended to limit the scope of the present disclosure.

[0014] The present disclosure will be more fully understood from the detailed description and the accompanying drawings.

Brief Description of the Drawings

[0015]

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[0016] In the drawings, reference numerals may be reused to identify similar and / or identical elements.

[0017] Referring to FIG. 1, the neurosurgical system 100 can include a surgical navigation system 104, a surgical microscope 108, a surgical cart 114, and a suction system 113. The surgical navigation system 104 includes a cart assembly 106 that houses a navigation computer 110. The navigation computer 110 may sometimes be referred to as a navigation controller. A navigation interface operably communicates with the navigation computer 110. The navigation interface can include one or more displays 120. The navigation interface can include one or more input devices for inputting information to or otherwise selecting / controlling certain aspects of the navigation computer 110. Such input devices can include an interactive (interactive) touch screen display / menu, keyboard, mouse, microphone (voice activation), gesture control device, and the like.

[0018] The navigation computer 110 can be configured to store one or more preoperative or intraoperative images of the brain. Any suitable imaging device can be used to provide preoperative or intraoperative images of the brain. For example, any 2D, 3D, or 4D imaging device such as isocentric fluoroscopy, biplane fluoroscopy, ultrasound, computed tomography (CT), multislice computed tomography (MSCT), magnetic resonance imaging (MRI), positron emission tomography (PET), optical coherence tomography (OCT), etc. The images can also be acquired and displayed in two dimensions, three dimensions, or four dimensions. In a more advanced form, a four-dimensional surface representing a region of the body can also be obtained by incorporating patient data or other data from an atlas or anatomical model map, or from preoperative image data captured by MRI, CT, or echocardiography. The phrase one or more images is used throughout this disclosure, but it is understood that this phrase can refer to preoperative images or intraoperative images taken during an excision procedure.

[0019] The navigation computer 110 can generate one or more images of the brain on the display 120. The navigation computer 110 can also be connected to the surgical microscope 108. For example, the display 120 can display an image corresponding to the field of view of the surgical microscope 108. The navigation computer 110 may include two or more displays, one of such displays showing the field of view of the surgical microscope 108 while the other of such displays may show one or more images of the brain.

[0020] The tracking system 124 can be an optical tracking system and can be coupled to the navigation computer 110. The tracking system 124 senses the posture (i.e., position and orientation) of navigation trackers attached to or integrated with one or more of the various surgical instruments described herein (e.g., the suction instrument 156, the bipolar forceps 160, the ultrasonic handpiece assembly 130), and is configured to provide the posture to the navigation computer 110 to determine, for example, the posture of the surgical instrument relative to the target region of the patient, as discussed in more detail below. Each navigation tracker can include one or more tracking elements that can be active or passive infrared tracking elements detectable by a camera of the optical tracking system. An example of a surgical navigation system 104 that includes a tracking system is the Nav3i™ commercially available from Stryker. The surgical navigation system 104 can have various functions and features as described in U.S. Patent No. 7,725,162 and U.S. Patent Application Publication No. 2020 / 0100849, which are hereby incorporated by reference in their entirety. Although an example where the tracking system 124 is an optical tracking system is provided, other tracking systems may be used.

[0021] For example, in some embodiments, the tracking system 124 can be implemented as an electromagnetic tracking system, and each navigation tracker includes a position sensor disposed within and / or embedded within the distal end of one of a variety of surgical instruments that enables, for example, the distal end of a surgical instrument to be tracked relative to a target region of a patient. More specifically, the position sensor can include a coil that communicates with one or more wire conduits extending along the length of the surgical instrument. When the position sensor, more specifically the coil, is positioned within an electromagnetic field, movement of the position sensor within that magnetic field causes an electric current to be generated within the coil, which can then be communicated along the wire conduit to the navigation computer 110. This phenomenon can enable the navigation computer 110 to determine the position of the distal end of the surgical instrument within a three-dimensional space relative to, for example, a target region of patient tissue.

[0022] By way of example only, the position sensor can be constructed and operable in accordance with at least some of the teachings of U.S. Patent No. 8,702,626, the disclosure of which is incorporated herein by reference; U.S. Patent No. 8,320,711, the disclosure of which is incorporated herein by reference; U.S. Patent No. 8,190,389, the disclosure of which is incorporated herein by reference; U.S. Patent No. 8,123,722, the disclosure of which is incorporated herein by reference; U.S. Patent No. 7,720,521, the disclosure of which is incorporated herein by reference; U.S. Patent Application Publication No. 2014 / 0364725, the disclosure of which is incorporated herein by reference; U.S. Patent Application Publication No. 2014 / 0200444, the disclosure of which is incorporated herein by reference; U.S. Patent Application Publication No. 2012 / 0245456, the disclosure of which is incorporated herein by reference; U.S. Patent Application Publication No. 2011 / 0060214, the disclosure of which is incorporated herein by reference; U.S. Patent Application Publication No. 2008 / 0281156, the disclosure of which is incorporated herein by reference; and / or U.S. Patent Application Publication No. 2007 / 0208252, the disclosure of which is incorporated herein by reference.

[0023] The surgical microscope 108 includes one or more objective lenses configured to provide a magnification in a certain range (for example, from about 2 times to about 50 times). The surgical microscope 108 can have a field of view having an area within a predetermined range. The surgical microscope 108 is configured, for example, for fluorescence microscopy for detecting PpIX. The surgical microscope 108 may include one or more excitation sources (for example, an excitation source configured to emit light in the visible light spectrum, or an excitation source configured to emit light in the infrared spectrum) for irradiating the brain tissue 111 with excitation light to cause PpIX to fluoresce. The surgical microscope 108 may include a camera capable of detecting radiation at the fluorescence wavelength of PpIX or ICG.

[0024] The surgical cart 114 can include a surgical system 112, a suction system 113, a tissue detection system 116, and an ultrasonic surgical system 118. A display 121 can be coupled to the surgical cart and operatively connected to the surgical system 112, the tissue detection system 116, and / or the ultrasonic surgical system 118 to display information associated with the systems 112, 116, and 118, respectively.

[0025] The suction device 156 can be connected to the suction system 113 via a suction tube. The suction system 113 can include one or more containers for storing the waste collected by the suction device 156. The suction system 113 may receive a suction force from a vacuum source such as a vacuum exhaust port of a medical facility. The suction system 113 can include one or more regulators or one or more adjustment valves for controlling the suction pressure received from the vacuum source. The one or more regulators or the one or more adjustment valves can be omitted, and the suction tube can be connected directly to the vacuum exhaust port or indirectly via one or more containers. In one example, the suction system 113 can correspond to a wall suction unit. In another example, the suction system 113 can correspond to a portable suction unit. The suction system 113 and the suction device 156 can have various features as described in U.S. Patent No. 9,066,658 and U.S. Patent Application Publication No. 20180344993, which are hereby incorporated by reference in their entirety.

[0026] The surgical system 112 can include a surgical instrument such as a bipolar forceps 160 and a surgical control console 115 for controlling various aspects of the surgical instrument. For example, the surgical system 112 can be configured so that the system controls the current output. A medical professional can also perform a surgical procedure on tissue using the surgical instrument. For example, for tissue ablation or tissue cauterization. The bipolar forceps may have features as described in U.S. Patent No. 8,361,070, which is hereby incorporated by reference in its entirety. This disclosure discusses and illustrates that the surgical instrument can include the bipolar forceps 160, but the surgical system 112 and the surgical instrument may include other instruments such as a nerve stimulator, dissector, or ablation device (e.g., RF ablation device and / or laser ablation device). For example, the surgical system and / or the surgical instrument may have various features as described in U.S. Patent No. 8,267,934, which is hereby incorporated by reference in its entirety. A medical professional can use any number of surgical systems and any number of surgical instruments when performing a surgical procedure.

[0027] The ultrasonic surgical system 118 can include an ultrasonic control console 128 and an ultrasonic handpiece assembly 130 that are used by a medical professional to ablate a brain tumor. The ultrasonic control console 128 can perform perfusion and / or aspiration via one or more tubes (not shown) connected to the ultrasonic handpiece assembly 130 to adjust the perfusion (washing) and / or aspiration function of the ultrasonic handpiece assembly 130 and can be configured to optimize the performance of the ultrasonic handpiece assembly 130. The ultrasonic handpiece assembly 130 can have various features as described in U.S. Patent No. 6,497,715, U.S. Patent No. 6,955,680, and U.S. Patent No. 6,984,220, and PCT Publication WO2020 / 068756, which are hereby incorporated by reference in their entirety. An example of an ultrasonic surgical system that can be used includes the Sonopet IQ ultrasonic aspirator, which is commercially available from Stryker. The ultrasonic control console 128 can control various operating parameters based on signals received from the tissue detection system 116.

[0028] The tissue detection system 116 can include a control console 168 and a sampling (sample) element 164. The control console 168 can generate real-time instructions visible within the sterile field via the sampling element 164 when the brain tissue 111 corresponds to tumorous tissue. The sampling element 164 can also be coupled to a bipolar forceps 160, a suction device 156, or other surgical instruments, as described in more detail below. The tissue detection system 116 determines if the brain tissue 111 corresponds to tumorous tissue based on fluorescence emitted by the target tissue caused by a fluorescent dye. In one example, the fluorescent dye can correspond to PpIX. In another example, the fluorescent dye can correspond to ICG. As described in more detail below, based on the intensity and wavelength of the fluorescence emitted by PpIX, the tissue detection system 116 can determine the presence of tumorous tissue.

[0029] Referring to FIG. 2, a schematic diagram of the neurosurgical system 100 is shown. The tissue detection system 116 enables a medical professional to detect the presence of PpIX in real time and can be used in conjunction with the surgical microscope 108 to improve the outcome of tumor resection procedures and the prospects of achieving GTR. During a surgical procedure, the medical professional can first observe the patient's brain tissue 111 using the surgical microscope 108 under excitation light (e.g., blue light) and identify which portions of the brain tissue 111 correspond to the target tissue evidenced by red fluorescence. The medical professional can switch the surgical microscope 108 to the original standard white light illumination for better visibility and start the resection of the target tissue. Since the sampling element 164 can be coupled to the suction instrument 156, the medical professional does not need to consider any additional surgical instruments (i.e., optical probes, etc.) in the sterile field. The medical professional can perform the resection of the target tissue using the bipolar forceps 160 in one hand and the suction instrument 156 in the other hand.

[0030] When the medical professional is resected the target tissue, the control console 168 can function to provide the medical professional with a real-time display of the target tissue within the brain tissue 111 by activating an indicator of the sampling element 164 (described in more detail below). The tissue detection system 116 according to the teachings of the present disclosure avoids the medical professional from alternately switching between various illumination settings (i.e., illuminating the tissue with excitation light and white light) of the surgical microscope 108 when the medical professional is performing the resection of the target tissue. This is particularly advantageous as the medical professional approaches the margin of the target tissue. This is because it is desirable for the medical professional to leave as much healthy tissue intact as possible while achieving GTR.

[0031] Referring to FIG. 3, the suction instrument includes a suction cannula 157 and a handle 159. The suction cannula 157 defines a lumen for suctioning fluid, debris, and tissue from a patient. The handle 159 has a tubular shape with a control portion 167. The distal end 162 of the handle 159 (or the distal end 162 of the control portion 167) may be tapered and is configured to receive the proximal end 161 of the suction cannula 157. The proximal end 165 of the handle 159 includes a vacuum fitting configured to receive a suction tube 169 connected to a vacuum source that generates a suction pressure. The vacuum fitting may be a standard spiked fitting, a quick disconnect, or any other suitable fitting known in the art that allows the suction tube to be fluidly coupled to the vacuum source.

[0032] The control portion 167 can include a teardrop-shaped control section 170 for adjusting the suction pressure. For example, if any part of the teardrop-shaped control section 170 is not covered by a medical professional, the suction pressure can be minimized, and when the teardrop-shaped control section 170 is fully covered, the suction pressure can be maximized. Although the control portion 167 is described as including a teardrop-shaped control section, the control portion 167 can include other suitable input sections such as buttons or control sections of different shapes that allow a medical professional to vary the suction pressure. As will be described in more detail below, the control portion 167 can include a through hole 171 for receiving a sampling element 164. A medical professional holds the suction instrument 156 from the handle 159 and operates the suction instrument 156 such that the distal end 163 contacts the patient's tissue during a surgical procedure to provide suction at a desired location. The suction instrument 156 is described as having a Fukushima-style configuration, but other configurations such as a Frazer configuration or a Pool configuration are also contemplated.

[0033] Referring to FIGS. 4 and 5, the tissue detection system 116 includes a sampling element 164 and a control console 168. As shown, the sampling element 164 can be coupled to the aspiration device 156. The sampling element 164 can be connected to the control console 168 via a connector 172. As will be discussed in more detail below, the sampling element 164 can include a detection fiber 264 and an indicator element 296. The control console 168 can include a controller 204, a user interface 208, a power supply 212, an optical system 215, and a microcontroller 220. The optical system 215 can include an optical block 216, a spectrometer 224, an excitation source 228, and an optical connector 229. The function of each component will be discussed in more detail below.

[0034] The user interface 208 can include a display for presenting the output from the controller 204 regarding fluorescence collected from the tissue. The user interface 208 can also include one or more inputs (e.g., push buttons, touch buttons, switches, etc.) configured for the involvement of a medical professional. The power supply 212 can supply power to the various components of the control console 168. The control console 168 can include a probe port 173 to which the connector 172 of the sampling element 164 is connected. Next, the detection fiber 264 can be connected to the optical block 216 via the optical connector 229, examples of which are shown in FIGS. 6A and 6B. The control console 168 can also include an electrical port 174 for establishing a communication link to, for example, the surgical system 112 and the ultrasonic surgical system 118. The communication link can also be established wirelessly.

[0035] The excitation source 228 can generate excitation light that is illuminated on the target tissue by a medical professional via the detection fiber 264. The excitation source 228 can be configured to emit excitation light within a predetermined wavelength range (e.g., blue light of about 405 nm, or blue light in the range of 400 nm to 500 nm). The excitation source 228 can also be configured to emit excitation light corresponding to wavelengths other than the blue light in the visible light spectrum (e.g., greater than 500 nm but less than 700 nm), as well as wavelengths related to the ultraviolet light spectrum (less than 400 nm) and / or wavelengths related to the infrared light spectrum (greater than 700 nm). The excitation source 228 can include any number of light sources such as light-emitting diodes (LEDs), pulsed lasers, continuous-wave lasers, modulated lasers, filtered white light sources, etc.

[0036] The system may further include another excitation source that is configured to emit excitation light corresponding to different wavelengths, different from those described above. In this embodiment, the excitation sources may be referred to as a first excitation source 228 and a second excitation source. The first excitation source 228 is configured to emit first excitation light within a first predetermined wavelength range of the visible light spectrum, and the second excitation source can be configured to emit infrared light within a second wavelength range corresponding to the infrared light spectrum (e.g., 700 nm to 1 mm). While the first excitation source 228 can be configured to emit light that excites a first fluorescent dye such as PpIX, the second excitation source is configured to emit light that excites a second fluorescent dye such as ICG.

[0037] The controller 204 can control the operation of the excitation source 228 by varying the operating parameters of the excitation source 228. The operating parameters can correspond to time settings, power settings, or other appropriate settings. The time setting can include a pulse width. The pulse width can be based on the integration time of the spectrometer 224. The integration time of the spectrometer 224 will be discussed in more detail below.

[0038] The detection fiber 264 can be coupled to the optical connector 229. When the sampling element 164 is coupled to the aspiration device 156, the distal end 272 of the detection fiber 264 is adjacent to the working portion of the surgical instrument, enabling the delivery of the excitation light to the target tissue.

[0039] Referring to FIGS. 6A and 6B, the optical block 216 is shown. The optical connector 229 can be coupled to the optical block 216. The optical block 216 can include an outer casing 274 constructed of metal or another suitable material and can completely surround the components 232 of the optical block 216. The optical block 216 can be L-shaped and can include a first portion 280 and a second portion 284. The excitation source 228 can be coupled to the first portion 280 of the optical block 216. The spectrometer 224 can be coupled to the second portion 284 of the optical block 216.

[0040] Referring further to FIGS. 7A and 7B, an exploded view of the components 232 of the optical system 215 is shown, illustrating the optical path 285 for the excitation light and the optical path 287 for the light collected from the brain tissue 111. The first portion 280 can include the optical path 285 for the excitation light to travel from one or more excitation sources 228 through the detection fiber 264 to the brain tissue 111. The optical path 285 can be defined by the components 232 within the first portion 280 of the optical block 216. The second portion 284 can include the optical path 287 for the collected light to travel from the brain tissue 111 through the detection fiber 264 to the spectrometer 224. The optical path 287 can be defined by the components 232 within the second portion 284 of the optical block 216. The components 232 of the optical block 216 can include optical components such as one or more laser line filters and one or more long pass filters. The optical block 216 can include other optical components such as one or more mirrors, lenses, optical connectors, optical fibers, and / or any other suitable optical components.

[0041] In FIG. 7A, excitation source 228 emits excitation light that travels through one or more components 232, such as a laser line filter and / or a bandpass filter. The laser line filter or bandpass filter can be configured to remove unwanted noise (e.g., low-level transitions, plasma, and glow) generated by excitation source 228. In other words, the laser line filter can be configured to remove excitation light or to make the excitation light more monochromatic. The long-pass filter can be configured to reflect light down detection fiber 264 and into brain tissue 111. Excitation source 228 may be configured to deliver unfiltered excitation light (i.e., the filter may be omitted) through detection fiber 264 to the target tissue. Detection fiber 264 can direct excitation light through sampling element 164 to brain tissue 111.

[0042] Detection fiber 264 can be configured to collect light from brain tissue 111 (i.e., fluorescence and ambient light). The coupling of sampling element 164 to the surgical instrument places distal end 272 adjacent to the working portion of the surgical instrument, enabling light to be collected from the target tissue. The light collected from brain tissue 111 may include ambient light and / or background light due to the presence of various light sources in the operating room, such as surgical microscope 108, a surgical lamp, or any other device in the operating room. Referring to FIG. 7B, the light collected by detection fiber 264 passes through a component 232, such as a long-pass filter in the second portion 284 of optical block 216. After passing through component 232, the light can enter spectrometer 224 coupled to optical block 216.

[0043] The detection fiber 264 can be coupled to the optical connector 229. As discussed in more detail below, the distal end 272 of the detection fiber 264 can include a lens or other transparent material such that when the sampling element 164 is positioned on a surgical instrument (i.e., an ultrasonic handpiece, a suction instrument or bipolar forceps, or other operative surgical instrument), by coupling the detection fiber 264 to the surgical instrument, the distal end 272 of the detection fiber 264 is adjacent to the working portion of the surgical instrument and can deliver the excitation light to the target tissue.

[0044] The spectrometer 224 can be configured to convert the filtered light into a spectral signal in the form of an electrical signal that can represent fluorescence collected from the tissue of the target region when the target region is excited by the excitation light. The microcontroller 220 is configured to control the operation of the spectrometer 224. Examples of available spectrometer systems are commercially available from Hamamatsu, including the Miniature Spectrometer Micro Series C12880MA. Although the spectrometer 224 is contemplated throughout the present disclosure, other optical devices may be used in place of the spectrometer 224.

[0045] Referring to FIG. 8, sampling element 164 and tracking element 166 are shown coupled to aspiration instrument 156. Tracking element 166 is shown coupled to handle 159 of aspiration instrument 156, but can be coupled to any portion of aspiration instrument 156. Tracking element 166 may be coupled to a portion of sampling element 164. Indicator element 296 can include a transmission member 297 connected to indicator light emitting portion 298. Indicator light emitting portion 298 can include one or more light emitting diodes or another suitable light source. Indicator light emitting portion 298 can be configured to emit light based on an activation signal received from controller 204. The controller can be configured to generate an activation signal in response to detection of tumorous tissue by controller 204. Indicator light emitting portion 298 can be spherical, dome-shaped, cylindrical, or another suitable shape. Jacket 306 can surround a portion of detection fiber 264 and a portion of indicator element 296, specifically transmission member 297. As shown in FIG. 9, jacket 306 does not cover distal end 272 of detection fiber 264 or indicator light emitting portion 298. Jacket 306 can be made from any one of polyvinyl chloride, polyethylene, chlorinated polyethylene, chlorosulfonated polyethylene / neoprene and / or another suitable material.

[0046] A portion of the detection fiber 264 and the indicator element 296 (i.e., the transmission member 297 and the indicator light-emitting portion 298) can be guided through the through-hole 171 of the handle 159. The distal end 272 of the detection fiber 264 can be positioned proximal to the distal end 163 of the aspiration cannula 157. The indicator light-emitting portion 298 can be positioned proximal to the distal end 272 of the detection fiber, but closer to the distal end 162 of the handle 159 (or the distal end 162 of the control portion 167) than the distal end 272 of the detection fiber is located. In other words, the distal end 272 of the detection fiber 264 can be disposed more proximally relative to the distal end 163 of the aspiration cannula 157 than the indicator light-emitting portion 298. Further referring to FIG. 9, after a portion of the detection fiber 264 and the indicator element 296 are supplied through the through-hole 171, the jacket 306 can be attached over the aspiration cannula 157, the detection fiber 264, and the transmission member 297. The jacket 306 can fit onto the distal end 162 of the control portion 167 such that the distal end 162 and the through-hole 171 are covered. The jacket 306 can terminate immediately before the indicator light-emitting portion 298 is coupled to the aspiration cannula 157. The detection fiber 264 can protrude from under the jacket 306 such that the jacket 306 does not interfere with the delivery of the excitation light or the collection of fluorescence from the tissue. Also, as shown, the indicator light-emitting portion 298 can be fully exposed or may be partially covered by the jacket 306. In some configurations, the jacket 306 may be omitted.

[0047] The sampling element 164 is shown coupled to the aspiration device 156, but the sampling element 164 may be coupled to another surgical instrument (e.g., the ultrasonic handpiece assembly 130, the bipolar forceps 160, etc.). The distal end 272 of the detection fiber 264 may include a lens, a collimator, or another suitable optical component that allows the detection fiber 264 to deliver the excitation light to the brain tissue 111 and collect light from the brain tissue 111.

[0048] As described above, the detection fiber 264 can carry excitation light from the optical system 215 to the brain tissue 111, and the detection fiber 264 can also collect light from the brain tissue 111 and deliver the light to the optical system 215. Examples are provided where the detection fiber 264 functions to deliver excitation light to the tissue and collect light from the tissue, but the system may alternatively include, for example, two separate fibers such as a collection fiber and an excitation fiber. The collection fiber can collect light from the tissue, and the excitation fiber can deliver excitation light to the tissue. The detection fiber 264 is considered as a single fiber for simplicity, but it is understood that the detection fiber 264 may include two or more fibers. For example, the detection fiber 264 can include a bundle of detection fibers that are all connected in a similar form to the single fiber connection described above. Further, the detection fiber 264 can include any number of fibers connected in series.

[0049] The controller 204 can be configured to utilize the spectral signal provided by the microcontroller 220 to determine or detect one or more characteristics of the collected fluorescence represented by the signal and to determine or detect the presence of neoplastic tissue. The controller 204 can apply or utilize any suitable algorithm or combination of algorithms to detect the presence of neoplastic tissue based on the fluorescence intensity of PpIX determined from the spectral signal. Exemplary algorithms are as disclosed in PCT application PCT / IB2022 / 052294, the contents of which are incorporated herein by reference. Based on the detection of neoplastic tissue or fluorescence intensity, the controller 204 can provide an indication to a medical professional that neoplastic tissue has been detected.

[0050] In response to the detection of the target tissue, the controller 204 can activate the indicator light-emitting unit 298. When activated, the indicator light-emitting unit 298 can emit light signaling to the medical professional that neoplastic tissue has been detected. The controller 204 can control an LED or other light source to emit various colors of light depending on whether the controller 204 detects PpIX or ICG (i.e., whether the brain tissue 111 corresponds to the target tissue or to blood vessels). For example, the controller 204 can control the LED to emit green light (e.g., with a wavelength of about 520 - 564 nm) when PpIX above a threshold is detected, and to emit yellow light (e.g., with a wavelength of 565 - 590 nm) when ICG is detected.

[0051] The controller 204 can be configured to communicate with the navigation computer 110 of the neurosurgical system 100 or any other system (e.g., the surgical system 112, the ultrasonic surgical system 118, etc.) via a communication link established through the electrical port 174. For example, a cable can be plugged into the electrical port 174 and also into the navigation computer 110 to establish the communication link. The communication link can also be established wirelessly. The controller 204 can provide the navigation computer 110 with spectral signals, determination of the detected fluorescence levels, and / or a determination of whether the tissue corresponds to healthy tissue or neoplastic tissue.

[0052] Referring to FIG. 10, the navigation computer 110 can be configured to display a graphical user interface (GUI) 131 together with an axial image 133 of the brain tissue 111 including the neoplastic tissue, a coronal image 134 of the brain tissue 111 including the neoplastic tissue, a sagittal image 135 of the brain tissue 111 including the neoplastic tissue, and a 3D model 136 of the brain tissue including the neoplastic tissue. The navigation computer 110 can be configured to display the posture of one or more of the surgical instruments such as the aspiration instrument 156 and the bipolar forceps 160 with respect to the target region of the image based on the tracking information received from the tracking system 124. The navigation computer 110 can be configured to segment the neoplastic tissue of the image using any suitable segmentation technique or combination of segmentation techniques, for example, an automatic segmentation technique, a semi-automatic segmentation technique, or a manual segmentation technique. The automatic or semi-automatic segmentation technique can utilize any suitable segmentation method, for example, a region growing method, a watershed method, a morphology-based method, a pixel-based method, an edge-based method, a model-based method, a fuzzy clustering method, or k-means clustering.

[0053] As described with reference to FIGS. 11-14, the navigation computer 110 can display one or more indicators that reflect in real time the resection status of the neoplastic tissue based on the detected fluorescence level, determination of tissue type, and / or the pose of one or more of the surgical instruments. The displayed resection status can be configured to alert the medical professional about any remaining portions of the tumor. The indicators can be overlaid on an image, a 3D model, or displayed alone. The indicators can be displayed in a variety of different forms such as one or more masks overlaid on one or more images (as shown in FIGS. 11A-11F), 2D points having different shapes / patterns / colors (as shown in FIGS. 13A and 13B), 3D point cloud models having different shapes / patterns / colors (as shown in FIG. 15), and / or any other suitable graphics. The indicators can also include deformations of existing graphics overlaid on one or more images (as shown in FIGS. 11A-11F and FIGS. 12A-12E).

[0054] Referring specifically to FIG. 11A, the axial image 133 of the GUI 131 is shown. During segmentation, the navigation computer 110 can overlay the segmentation mask 404 over the neoplastic tissue to highlight the region of interest. Alternatively, the navigation computer 110 can draw or outline the neoplastic tissue to highlight the region of interest. The navigation computer 110 can prompt the medical expert to provide an input indicating the margin around the neoplastic tissue for resection. The margin is the plane along which the resection is to be performed and ideally separates healthy tissue from the outside of the neoplastic tissue. Based on the input provided by the medical expert, the navigation computer 110 can display a margin mask 408 representing the margin around the segmentation mask 404. The margin and the neoplastic tissue together can be referred to as the target region. The margin mask 408 can have a visually different appearance from the segmentation mask 404, such as a different color or a different pattern. As shown in FIG. 11A, the margin mask 408 is shown having a white pattern (e.g., a first pattern).

[0055] The navigation computer 110 can be configured to generate one or more three-dimensional models (3D) of the brain, tumorous tissue, and / or target area based on the images. The 3D model of the tumorous tissue can be reconstructed based on the segmented tumorous tissue of each of the 2D images processed from the 3D image. For example, when the tumorous tissue is segmented, the 2D image having the tumorous tissue can be reconstructed within the 3D model by placing this 2D image back into the sequence for providing the 3D model. Based on the reconstructed 3D model of the tumorous tissue, the navigation computer 110 can calculate the volume of the tumorous tissue, or other parameters such as the position and shape within the brain. The navigation computer 110 can also be configured to include a margin selected by a medical expert in the 3D model. The navigation computer 110 can be configured to perform one or more volume calculations of the target area, including the volume of the tumorous tissue to be resected, the volume of the margin to be resected, and the total volume including the volume of the tumorous tissue and the volume of the margin to be resected. The calculation can be displayed with respect to the image.

[0056] The navigation computer 110 can be configured to perform registration of the image or the patient using any suitable registration method that correlates the intraoperative pose of the patient with the image. The navigation computer 110 can perform registration of the image or the patient using an automatic image registration or a manual image registration method. For example, the navigation computer 110 can be configured to execute a point-based registration method. The navigation computer 110 can use one of the registration methods described in U.S. Patent No. 10,506,962, the content of which is incorporated herein by reference. After the registration is executed, the pose of the suction instrument 156 and / or the bipolar forceps 160 or other surgical instruments with respect to the image can be displayed.

[0057] As shown in FIG. 11B, before the start of the resection procedure, the navigation computer 110 can superimpose the second mask 412 on the segmentation mask 404. As shown in FIG. 11B, the second mask 412 is displayed over the entire portion of the initial segmentation mask 404. When the second mask 412 is first displayed before the start of the resection of the target region 402, the portion of the initial segmentation mask 404 is not visible. Referring to FIGS. 11C-11F, as the medical professional resections the target region 402, the navigation computer 110 can modify the margin mask 408 and the second mask 412 to reflect the resection status of the target region 402. For example, the navigation computer 110 can change the color or pattern of the regions of the second mask 412 and / or the margin mask 408 corresponding to a portion of the resected target region 402. In another example, the navigation computer 110 can remove or delete the second mask 412 and / or the margin mask 408 as the medical professional resections the relevant tissue. In other words, when the medical professional resections the neoplastic tissue, the portion of the second mask 412 covering the corresponding portion of the neoplastic tissue can be removed. Additionally, the navigation computer 110 can display a resection window (pane, frame) 440 that displays various calculations by the navigation computer 110, such as the total volume of the target region 402 or tumor to be resected, the total volume of the target region 402 or tumor remaining to be resected, and / or the degree of resection (e.g., percentage complete), etc. (the latter can be determined based on one or more of the former calculations).

[0058] Referring particularly to FIG. 11C, as the medical professional performs the resection of the target region 402, the navigation computer 110 can update the resection window 440 to reflect various real-time calculations. In FIG. 11C, the resection window 440 shows that the medical professional has completed 25% of the resection corresponding to 12.5 cm of the total target region of 50 cm 3 of the total target region, corresponding to 12.5 cm 3Indicates that the resection has been performed. As shown in the illustration, the navigation computer 110 changed the target area 402 displayed on the screen so as to reflect the range of the removed target area 402. The navigation computer 110 removed the portion of the second mask 412 associated with the portion of the tumorous tissue to be removed. The navigation computer 110 also changed the margin mask 408 by changing the pattern of a portion of the margin mask 408 in proportion to the amount of margin tissue removed by the medical professional.

[0059] Referring particularly to FIG. 11D, the resection window 440 indicates that the medical professional has resected 50% of the target area 402. Accordingly, the navigation computer 110 removed 50% of the second mask 412 and, correspondingly, changed the margin mask 408 so as to reflect the portion of the removed target area 402. Referring to FIG. 11E, as shown in the resection window 440, the medical professional here removed 37.5 cm corresponding to 75% of the target area 402. 3 Accordingly, the navigation computer 110 removed 75% of the second mask 412 and, correspondingly, changed the margin mask 408 so as to reflect the portion of the removed target area 402.

[0060] Referring to FIG. 11F, the resection window 440 indicates that the resection is 100% complete when the total resected volume of 50 cm 3 is equal to the total volume of the target area 402 of 50 cm 3 As shown in the illustration, when the target area 402 has been completely resected, the navigation computer 110 no longer displays the portion of the second mask 412. In addition, the navigation computer 110 can display the entire margin mask 408 as the changed margin mask to indicate that the entire margin area has been resected.

[0061] Referring to FIGS. 12A - 12E, as described above, instead of generating the segmentation mask 404 shown in FIGS. 11A - 11F, the navigation computer 110 can generate a contour 409 around the neoplastic tissue based on one or more images. Referring to FIGS. 12B - 12E, when a medical professional is excising the neoplastic tissue, the navigation computer 110 can be configured to fill the area inside the contour 409 based on the posture of one or more of the surgical instruments (i.e., the suction instrument 156 and / or the bipolar forceps 160), the level of fluorescence detected in each posture, and / or the determination of the tissue type in each posture.

[0062] As shown in FIG. 12A, the medical professional has not yet started the excision procedure of the neoplastic tissue indicated by the contour 409. Accordingly, the contour 409 of the neoplastic tissue is shown in an unfilled state, and the excision window 440 indicates an excision status of 0% completion, 0 cm 3 of total excised volume, and 50 cm 3 of total target area volume to be excised. As shown in FIG. 12B, the contour 409 of the neoplastic tissue is shown to be approximately 25% filled based on the posture of one or more of the surgical instruments (i.e., the suction instrument 156 and / or the bipolar forceps 160), the level of fluorescence detected in each posture, and / or the determination of the tissue type in each posture. The excision window 440 indicates an excision status of 25% completion, 12.5 cm 3 of total excised volume, and 50 cm 3 of total target area volume to be excised. As shown in FIG. 12C, the contour 409 of the neoplastic tissue is shown to be approximately 50% filled based on the posture of one or more of the surgical instruments (i.e., the suction instrument 156 and / or the bipolar forceps 160), the level of fluorescence detected in each posture, and / or the determination of the tissue type in each posture. The excision window 440 indicates an excision status of 50% completion, 25 cm 3 of total excised volume, and 50 cm 3Shows the total volume of the target area to be resected. As shown in FIG. 12D, the contour 409 of the neoplastic tissue is shown filled to about 75% based on the posture of one or more of the surgical instruments (i.e., the suction instrument 156 and / or the bipolar forceps 160), the level of fluorescence detected in each posture, and / or the determination of the tissue type in each posture. The resection window 440 is at 75% resection completion, 37.5 cm 3 of the total resected volume, and 50 cm 3 Shows the total volume of the target area to be resected. As shown in FIG. 12E, the contour 409 of the neoplastic tissue is shown filled to 100% based on the posture of one or more of the surgical instruments (i.e., the suction instrument 156 and / or the bipolar forceps 160), the level of fluorescence detected in each posture, and / or the determination of the tissue type in each posture. The resection window 440 is at 100% resection completion, 50 cm 3 of the total resected volume, and 50 cm 3 Shows the total volume of the target area to be resected.

[0063] Referring to FIGS. 13A-13B, which are similar to FIGS. 12A-12E, the segmented tumorous tissue is indicated by contour 409. As described above, during the resection procedure, due to brain displacement, the tumorous tissue may move from its initially registered pose. Thus, the pose of the tumorous tissue in the patient space may not correspond to the pose of the tumorous tissue in the image space. However, when brain displacement occurs, medical experts using prior art neurosurgical systems cannot know the resulting brain displacement by examining general preoperative or intraoperative images taken before the brain displacement occurred. Using the neurosurgical system of the present disclosure, the navigation computer 110 can overlay one or more indicators related to the image based on the pose of one or more of the surgical instruments (i.e., the suction instrument 156 and / or the bipolar forceps 160), the detected fluorescence level, and / or the determination of the tissue type. The medical expert can examine one or more images with the indicators overlaid on the images to evaluate the extent of brain displacement and whether additional intraoperative imaging is warranted. Referring particularly to FIG. 13A, the indicators are shown as point indicators 413, 414. In FIG. 13A, the navigation computer 110 overlays a first point indicator 413 that indicates the location where fluorescence, or more specifically, fluorescence corresponding to a given type of tissue (e.g., the target or tumorous tissue), has been detected. The first point indicator 413 is shown in solid color. The navigation computer 110 overlays one or more second point indicators 414 on the one or more images that indicate the locations where fluorescence, or more specifically, fluorescence corresponding to a given type of tissue (e.g., the target or tumorous tissue), has not been detected. The second point indicator 414 is indicated by a hollow circle. As can be seen from FIG. 13A, all of the first point indicators 413 are within the contour 409 of the segmented tumorous tissue, and all of the second point indicators are outside the contour 409 of the segmented tumorous tissue.Accordingly, a medical professional can determine whether there is no brain shift or a small amount of brain shift has occurred. Referring to FIG. 13B, the first point indicator 413 (i.e., the point indicating that fluorescence has been detected) is shown outside the contour 409 of the segmented tumorous tissue, and the second point indicator 414 (i.e., the point indicating that no fluorescence has been detected) is within the contour 409 of the segmented tumorous tissue. Accordingly, a medical professional can determine that a significant brain shift has occurred. When it is determined that a significant brain shift has occurred, a medical professional may choose to perform additional intraoperative imaging to re-evaluate the tumorous tissue with respect to healthy tissue.

[0064] The navigation computer 110 can be configured to store, as resection data, the posture of a surgical instrument (i.e., the suction instrument 156 and / or the bipolar forceps 160) with respect to a target region including tumorous tissue, along with an associated determination based on fluorescence emitted from and collected from the tissue as to whether the tissue associated with each posture is tumorous tissue or healthy tissue. When the navigation computer 110 has collected sufficient resection data, the navigation computer 110 can account for brain shift using the resection data. More specifically, when sufficient resection data has been collected, the navigation computer 110 can configure the resection data to match the shape or contour of a portion of the tumorous tissue. Referring to FIG. 13, the tumorous tissue shown by the segmentation mask 404 can include one or more unique portions defined by a unique shape. The navigation computer 110 can use the unique portions to derive one or more transformation functions between the patient space and the image space for the unique shape. Next, the navigation computer 110 can estimate the updated posture of the tumorous tissue with respect to an image in which brain shift has occurred using one or more of the derived transformation functions. In this way, the system according to the present disclosure can help to address brain shift that occurs during a resection procedure.

[0065] Based on the known spatial relationships between the neoplastic tissue collected from the image and important / eloquent brain structures such as the sensorimotor cortex, language cortex, and subcortical structures (e.g., basal ganglia and internal capsule), the navigation computer 110 can derive one or more transformation functions for determining the modified posture of one or more important brain structures affected by brain shift. In one example, the navigation computer 110 can be configured to derive a transformation function for important brain structures within a threshold range of the neoplastic tissue. In other words, in the example provided, the navigation computer 110 can be configured to derive a transformation function for important brain structures that are at the highest risk of being affected during the resection procedure.

[0066] Referring to FIG. 14, when the navigation computer 110 derives a transformation function for a unique portion of the neoplastic tissue, the navigation computer 110 can be configured to calculate the modified posture of the neoplastic tissue and / or one or more important brain structures. As shown in FIG. 14, the navigation computer 110 superimposes a third mask 420 representing the calculated modified posture of the neoplastic tissue over one or more images. Although not shown in FIG. 14, the navigation computer 110 can also be configured to superimpose one or more graphics representing the calculated modified postures of important brain structures that are at the highest risk of being affected during the resection procedure.

[0067] Referring to FIG. 15, the navigation computer 110 can be configured to display a graphical user interface (GUI) 137 that includes a 3D point cloud 504 that includes the measured fluorescence intensity of PpIX of the excised tissue, a 3D model of the excised neoplastic tissue 520, and a 3D model of the neoplastic tissue 530. The 3D point cloud can be generated based on the posture of the surgical instrument (i.e., the suction instrument 156 and / or the bipolar forceps 160) and the detected fluorescence level. The navigation computer 110 can plot various points having various levels of RGB (red, green, blue) to represent the various detected levels of fluorescence. For example, the navigation computer 110 plots red points to indicate that the fluorescence intensity of PpIX is above a first threshold (i.e., the tissue corresponds to neoplastic tissue), plots green to indicate that no fluorescence is detected or that the fluorescence intensity of PpIX is below a second threshold (i.e., the tissue corresponds to healthy tissue), or plots other colors to indicate that the fluorescence intensity of PpIX is below the first threshold but above the second threshold (i.e., the tissue type cannot be immediately determined from the fluorescence level). The 3D point cloud 504 having RGB indicators at various levels is more useful for a medical professional to understand the heterogeneity of the neoplastic tissue. The 3D point cloud 504 can also be generated with various shapes / patterns to represent various levels of fluorescence intensity of PpIX. Based on the 3D point cloud 504, a medical professional may be able to gather additional knowledge regarding where the most aggressive and most cancerous cells are present and where the neoplastic tissue is most likely to occur.

[0068] In the 3D point cloud 504 of FIG. 15, the solid circle 508 indicates that the fluorescence intensity of PpIX is equal to or greater than the first threshold value, the hollow circle 512 indicates that no fluorescence is detected or the fluorescence intensity of PpIX is less than the second threshold value, and the square 510 indicates that the fluorescence intensity of PpIX is less than the first threshold value but equal to or greater than the second threshold value (i.e., intermediate-level fluorescence is detected). Based on the point cloud data, the navigation computer 110 can generate a 3D model of the resected neoplastic tissue 520. For example, the navigation computer 110 can generate a convex hull based on the 3D point cloud 504, particularly the 3D point cloud data where the fluorescence intensity of PpIX is equal to or greater than the first threshold value. A medical expert can evaluate the resection status by comparing the shape of the 3D model of the resected neoplastic tissue with the shape of the 3D model of the neoplastic tissue 530.

[0069] Referring to FIGS. 16 and 17, two flowcharts showing the method implemented by the neurosurgical system 100 are shown. As will become apparent from the following description, the method represents only an exemplary and non-limiting flowchart for explaining a particular method implemented by the neurosurgical system 100. The method is in no way intended to serve as a complete or comprehensive method implemented by the neurosurgical system 100. Although the method is shown as ending, the method may return to the beginning and be executed as a continuous loop.

[0070] Referring particularly to FIG. 16, method 600 is shown. At 604, method 600 can receive one or more medical images. At 608, method 600 can segment the tumorous tissue of the medical image. At 612, method 600 can perform image / patient registration. At 612, method 600 can track the posture of one or more surgical instruments such as the aspiration device 156 or the bipolar forceps 160. At 620, method 600 can receive the collected light from the target region 402. At 624, the method can determine the fluorescence intensity. At 628, method 600 can determine whether the tissue corresponds to tumorous tissue or healthy tissue based on the fluorescence intensity. At 632, method 600 can overlay one or more indicators on one or more medical images, and the method can end or return to 604 to continue.

[0071] Referring particularly to FIG. 17, method 700 is shown. At 704, method 700 can receive one or more medical images and segment the tumorous tissue of the medical image. At 708, method 700 can perform image / patient registration. At 712, method 700 can track the pose of one or more surgical instruments such as aspiration instrument 156 or bipolar forceps 160. At 716, method 700 can receive the collected light from the target area. At 720, the method can determine the fluorescence intensity. At 724, method 700 can determine whether the fluorescence intensity is less than a first threshold. If it is less than the first threshold, method 700 can proceed to 728, and if not, method 700 can proceed to 732. At 728, method 700 can plot 3D points based on the pose of one surgical instrument having a first color and / or a first symbol and can proceed to 744. At 744, method 700 can determine whether an input about the model has been received from a medical expert. If received, method 700 can proceed to 748, and at 748, method 700 can generate a model based on the 3D point cloud. If no input for generating the model is received from the medical expert, method 700 can end or can return to 704 and continue.

[0072] At 732, method 700 can determine whether the fluorescence intensity is less than a second threshold. If it is less than the second threshold, method 700 can proceed to 736, and if not, method 700 can proceed to 740. At 736, method 700 can plot 3D points based on the pose of one surgical instrument having a second color and / or a second symbol, and method 700 can proceed to 744. At 740, method 700 can plot 3D points based on the pose of one surgical instrument having a third color and / or a third symbol, and the method can proceed to 744.

[0073] Some of the functions, features, and processes described above have been described with reference to brain procedures, but it will be understood that such functions, features, and processes can also be applied to other human organs. In other words, the navigation computer 110 can be configured to track the resection status during a resection procedure involving an alternative organ and / or take into account organ displacement, as described above.

[0074] The broad teachings of the present disclosure can be implemented in a variety of forms. Accordingly, while the present disclosure includes specific examples, other variations will become apparent upon consideration of the drawings, the specification, and the following claims, and the true scope of the present disclosure should not be so limited. It should be understood that one or more steps within a method can be executed in a different order (or simultaneously) without changing the principles of the present disclosure. Further, while each example has been described above as having specific features, any one or more of these features described with respect to any example of the present disclosure can be implemented in any of the features of other examples and / or combined with any of the features of other examples, even if such combination is not explicitly described. In other words, the described examples are not mutually exclusive, and substitution of one or more examples with each other remains within the scope of the present disclosure.

[0075] Spatial and functional relationships between elements (e.g., between controllers, between circuit elements, between semiconductor layers, etc.) are described using various terms including "connected," "engaged," "coupled," "adjacent," "next to," "on," "above," "below," and "disposed." Unless explicitly stated to be "direct," when the relationship between a first element and a second element is described in the above disclosure, the relationship can be a direct relationship in which no other intervening elements exist between the first element and the second element, but can also be an indirect relationship in which one or more intervening elements exist (either spatially or functionally) between the first element and the second element.

[0076] As used herein, the phrase "at least one of A, B, and C" should be construed to mean a logical (A OR B OR C) using non-exclusive logical OR, and should not be construed to mean "at least one of A, at least one of B, and at least one of C". The term subset does not necessarily require a proper subset. In other words, the first subset of the first set may have the same extent as (be equal to) the first set.

[0077] In the figure, the direction of the arrow generally indicates the flow of information (such as data or instructions) that is important for the figure, as indicated by the head of the arrow. For example, if element A and element B exchange a variety of information, and the information transmitted from element A to element B is relevant to the figure, the arrow may point from element A to element B. This one-way arrow does not mean that no other information is transmitted from element B to element A. Further, with respect to the information sent from element A to element B, element B can send a request for information or an acknowledgment of receipt to element A.

[0078] In this application, including the following definitions, the terms "controller" or "module" may be replaced with the term "circuit". The term "controller" refers to an application specific integrated circuit (ASIC), a programmable system on chip (PSoC), a digital, analog, or analog / digital mixed discrete circuit, a digital, analog, or analog / digital mixed integrated circuit, a combinational logic circuit, a field programmable gate array (FPGA), a processor circuit (shared, dedicated, or group) that executes code, a memory circuit (shared, dedicated, or group) that stores the code executed by the processor circuit, other suitable hardware components that provide the described functionality, or a system on chip, etc., and can refer to some or all of the above combinations, be a part of them, or include them.

[0079] The controller may include one or more interface circuits with one or more transceivers. In some examples, the interface circuit can implement a wired or wireless interface to connect to a local area network (LAN) or a wireless personal area network (WPAN). Examples of LANs include the Institute of Electrical and Electronics Engineers (IEEE) Standard 802.11-2016 (also known as the WIFI (registered trademark) wireless network standard) and the IEEE Standard 802.3-2015 (also known as the ETHERNET (registered trademark) wired network standard). Examples of WPANs include the BLUETOOTH wireless network standard from the Bluetooth (registered trademark) Special Interest Group and the IEEE Standard 802.15.4.

[0080] The controller can communicate with other controllers using the interface circuit. In the present disclosure, the controller may be shown as communicating logically directly with other controllers, but in various embodiments, the controller can actually communicate via a communication system. The communication system can include physical and / or virtual networking devices such as hubs, switches, routers, gateways, transceivers, etc. In some embodiments, the communication system connects to or traverses a wide area network (WAN) such as the Internet. For example, the communication system can include multiple LANs connected to each other via the Internet or a point-to-point dedicated line using technologies including Multiprotocol Label Switching (MPLS) and Virtual Private Networks (VPN).

[0081] In various embodiments, the functions of the controller can be distributed among a plurality of controllers connected via a communication system. For example, multiple controllers may perform the same function distributed by a load balancing system. In a further example, the functions of the controller can be split between a server (also known as a remote or cloud) controller and a client (or user) controller.

[0082] Some or all of the hardware features of the controller can be defined using a hardware description language such as IEEE standard 1364 - 2005 (commonly referred to as "Verilog") and IEEE standard 1076 - 2008 (commonly referred to as "VHDL"). Using a hardware description language, a hardware circuit can be manufactured and / or programmed. In some implementations, some or all of the functions of the controller can be defined by a language such as IEEE 1666 - 2005 (commonly referred to as "SystemC") that includes both code and hardware descriptions as described below.

[0083] The term "code" as used above can include software, firmware, and / or microcode, and can refer to a program, routine, function, class, data structure, and / or object. The term "shared processor circuit" encompasses a single processor circuit that executes some or all of the code from multiple controllers. The term "group processor circuit" encompasses a processor circuit that, in combination with additional processor circuits, executes some or all of the code from one or more controllers. References to multiple processor circuits include multiple processor circuits on separate dies, multiple processor circuits on a single die, multiple cores of a single processor circuit, multiple threads of a single processor circuit, or combinations of the above. The term "shared memory circuit" encompasses a single memory circuit that stores some or all of the code from multiple controllers. The term "group memory circuit" encompasses a memory circuit that, in combination with additional memory, stores some or all of the code from one or more controllers.

[0084] The term "memory circuit" is a subset of the term "computer-readable medium". The term "computer-readable medium", as used herein, does not include transient electrical or electromagnetic signals propagating in a medium (such as a carrier wave). Thus, the term "computer-readable medium" may be considered tangible and non-transitory. Non-limiting examples of non-transitory computer-readable media are non-volatile memory circuits (such as flash memory circuits, erasable programmable read-only memory circuits, or mask read-only memory circuits), volatile memory circuits (such as static random access memory circuits or dynamic random access memory circuits), magnetic storage media (such as analog or digital magnetic tape, or hard disk drives), and optical storage media (such as CDs, DVDs, or Blu-ray (registered trademark) discs).

[0085] The apparatus and method described in this application can be implemented partially or fully by a special-purpose computer created by configuring a general-purpose computer to perform one or more specific functions embodied in a computer program. The functional blocks and flowchart elements described above can function as software specifications that can be converted into a computer program by the routine work of a skilled technician or programmer.

[0086] The computer program includes processor-executable instructions stored on at least one non-transitory computer-readable medium. The computer program can also include or be dependent on stored data. The computer program can include a basic input / output system (BIOS) that interacts with the hardware of the special-purpose computer, device drivers that interact with specific devices of the special-purpose computer, one or more operating systems, user applications, background services, background applications, and the like.

[0087] A computer program may include (i) descriptive text to be analyzed such as HTML (HyperText Markup Language), XML (Extensible Markup Language), or JSON (JavaScript® Object Notation), (ii) assembly code, (iii) object code generated from source code by a compiler, (iv) source code executed by an interpreter, (v) source code to be compiled and executed by a just-in-time compiler, etc. By way of example only, source code can be written using syntax from languages including C, C++, C#, Objective-C, Swift, Haskell, Go, SQL, R, Lisp, Java®, Fortran, Perl, Pascal, Curl, OCaml, JavaScript®, HTML5 (HyperText Markup Language Fifth Edition), Ada, ASP (Active Server Pages), PHP (PHP: Hypertext Preprocessor), Scala, Eiffel, Smalltalk, Erlang, Ruby, Flash®, Visual Basic®, Lua, MATLAB®, SIMULINK®, and Python®.

Claims

1. A neurosurgical system for determining the resection status during a tumor resection procedure, A suction device comprising a navigation tracker and a suction cannula for defining the lumen, configured to apply suction to a target area of ​​the patient, including a tumor, An optical fiber coupled to the aspiration cannula and configured to collect fluorescence emitted from the target region, An excitation source configured to emit excitation light and induce the fluorescence emitted from the target region, It is a surgical navigation system, Acquire at least one medical image of the target region of the patient, Based on the orientation of the navigation tracker, the orientation of the suction device relative to the target area is determined, Determining whether the tissue in the target region associated with the posture of the suction device corresponds to the tumor is based on the collected fluorescence associated with the posture of the suction device, Based on the determination of whether the tissue corresponds to the tumor and the orientation of the suction device, the excision status of the target region with respect to the at least one medical image is displayed on the display. A surgical navigation system configured to perform the following: A neurosurgical system equipped with the following features.

2. The neurosurgical system according to claim 1, wherein the surgical navigation system is configured to alert a medical professional about the residual portion of the tumor.

3. The surgical navigation system is In response to the determination that the tissue corresponds to the tumor, a first indicator is superimposed on the at least one medical image of the patient based on the orientation of the suction device, In response to the determination that the tissue does not correspond to the tumor, a second indicator is superimposed on the at least one medical image of the patient based on the orientation of the suction device. The neurosurgical system according to claim 1, configured to cause the display to perform the operation.

4. The surgical navigation system is configured to generate a 3D model of the patient's brain, The neurosurgical system according to claim 3, wherein the first indicator and the second indicator are displayed as a point cloud model relating to the 3D model.

5. The neurosurgical system according to any one of claims 1 to 4, wherein the surgical navigation system is configured to store the position of the suction device and a related determination of whether the tissue corresponds to the tumor as resection data.

6. The neurosurgical system according to claim 5, wherein the surgical navigation system is configured to calculate, based on the resection data, at least one of the volume of the remaining tissue corresponding to the tumor and the volume of the resected tissue corresponding to the tumor.

7. The neurosurgical system according to claim 6, wherein the surgical navigation system is configured to calculate the degree of resection based on at least one of the volume of the remaining tissue corresponding to the tumor and the volume of the resected tissue corresponding to the tumor.

8. The neurosurgical system according to any one of claims 1 to 4, further comprising storing as resection data the characteristics of collected fluorescence emitted from the target region for each of a plurality of stored positions of the suction instrument relative to the target region, and a relevant determination as to whether the tissue associated with the stored position corresponds to the tumor.

9. The target region is a part of the patient's brain, The neurosurgical system according to any one of claims 1 to 4, wherein the surgical navigation system is configured to take into account the displacement of at least a portion of the brain that occurs during the resection procedure.

10. The neurosurgical system according to claim 9, wherein, in order to take into account the displacement of at least a portion of the brain, the surgical navigation system predicts the position of the tumor with respect to the at least one medical image, based on excision data indicating a relevant determination based on collected fluorescence emitted from the tissue, whether the tissue in the target region associated with the stored position corresponds to the tumor.

11. In order to predict the position of the tumor, the surgical navigation system shall Matching a portion of the aforementioned excision data with a portion of the tumor's contour, Estimating the orientation of the tumor with respect to at least one medical image based on the portion of the excision data matched to the portion of the contour of the tumor. The neurosurgical system according to claim 10, configured to perform the following:

12. A computer-operated program for determining the resection status during a tumor resection procedure, wherein the program, when executed by a surgical navigation system, enables the surgical navigation system to: The steps include: acquiring at least one medical image of a target region of a patient including a tumor; A step of determining the orientation of the suction device relative to the target area based on the orientation of a navigation tracker attached to the suction device, The steps include generating excitation light in an excitation source to excite the target region, The steps include receiving the collected fluorescence emitted from the target region and associated with the orientation of the suction device through at least one optical fiber coupled to the suction device, A step of determining whether the tissue in the target region associated with the posture of the suction device corresponds to the tumor, based on the collected fluorescence associated with the posture of the suction device, A step of displaying the excision status of the target region with respect to the at least one medical image, based on the determination of whether the tissue corresponds to the tumor and the position of the suction device. A program that contains instructions to execute something.

13. A neurosurgical system for determining the resection status during a tumor resection procedure, A surgical instrument configured to apply suction to a target area of ​​a patient, including a tumor, An optical fiber connected to the surgical instrument and configured to collect fluorescence emitted from the target region, An excitation source configured to emit excitation light and induce the fluorescence emitted from the target region, It is a surgical navigation system, To obtain at least one medical image of the patient's target region, including the tumor, Determining the orientation of the surgical instrument relative to the target region, When the target region is excited by the excitation light, an electrical signal representing fluorescence collected from the target region is received, The electrical signal is analyzed to determine one or more characteristics of the collected fluorescence. Based on one or more characteristics of the collected fluorescence and the orientation of the surgical instrument, the excision status of the target region is displayed for the at least one medical image. A surgical navigation system configured to perform the following: A neurosurgical system equipped with the following features.

14. A computer-executed program for determining the resection status of a tumor target region, wherein the program, when executed by a surgical navigation system, enables the surgical navigation system to: The steps include: acquiring at least one medical image of a target region of a patient including a tumor; A step of determining the orientation of the surgical instrument relative to the target area, The steps include: using an optical fiber coupled to the surgical instrument, receiving an electrical signal representing fluorescence collected from the target region when the target region is excited by the excitation light; The steps include analyzing the electrical signal to determine one or more characteristics of the collected fluorescence, A step of displaying the excision status of the target region for the at least one medical image based on one or more characteristics of the collected fluorescence and the orientation of the surgical instrument. A program that contains instructions to execute something.

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