Neurosurgical methods and systems for detecting and removing tumor tissue

Abstract

A neurosurgical system for examining a patient's brain tissue for tumor tissue. The system includes an aspiration instrument, an excitation source, an optical instrument, and a controller. The aspiration instrument includes an aspiration cannula defining a lumen, an optical fiber configured to transmit fluorescence emitted by the brain tissue, and an indicator configured to selectively emit visible light. The excitation source is configured to emit excitation light having a wavelength that induces fluorescence in the tumor tissue. The optical instrument is connected to the optical fiber. The optical instrument is configured to transduce the fluorescence emitted by the brain tissue and transmitted by the optical fiber, and is configured to determine that the brain tissue is tumorous based on the electrical signal and activate the indicator based on the determination.

Description

Technical Field

[0001] Cross - reference to Related Applications This application claims the priority and all advantages of U.S. Provisional Patent Application No. 63 / 160,099, filed on March 12, 2021, and the content of this provisional application is incorporated herein by reference.

Background Art

[0002] Glioma tumors can occur in the glial cells of the brain or spinal cord. For tumor resection, surgical procedures, more specifically tumor resection, are often performed. The goal of the surgical procedure for tumor resection is to achieve gross total resection (GTR). A very aggressive glioma is glioblastoma. In glioblastoma patients, it has been found that GTR can extend the patient's lifespan by about 40% (e.g., from 10 months to 14 months). In patients with low - grade gliomas, GTR increases the overall likelihood of survival.

[0003] 5 - Aminolevulinic acid (5 - ALA) is often administered to patients several hours before surgery. 5 - ALA is a compound that occurs naturally in the hemoglobin synthesis pathway. In cancer cells, hemoglobin synthesis is disrupted, and the pathway stops at an intermediate compound called protoporphyrin IX (PPIX). During surgery, medical professionals may irradiate areas of 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. High - grade tumor cells containing PPIX absorb the excitation light and emit fluorescence (red fluorescence) with specific optical properties. The fluorescence may be observed by medical professionals through a surgical microscope.

[0004] Once the target tissue is identified, the medical professional returns the surgical microscope to standard white light illumination and continues excising the target tissue. Throughout the surgical procedure, the medical professional alternates between white light and excitation light illumination to ensure that the appropriate target tissue is removed until the tumor is completely excised. Each time the target area is illuminated with excitation light from the surgical microscope, PPIX present in the tumor site may degrade due to photobleaching caused by irradiation with strong excitation light.

[0005] Fluorescence-guided surgery increases the likelihood of guided resection (GTR) in high-grade tumors such as glioblastoma. Currently, GTR in low-grade tumors is relatively low. This is because tumor cells emit only low levels of fluorescence, and the human eye is not sensitive enough to detect such low levels of fluorescence even with a surgical microscope, making it impossible to use 5-ALA to improve the outcome of low-grade tumor resection. Improved systems for fluorescence-induced surgery are needed to increase the likelihood of achieving GTR.

[0006] The background information provided herein is intended to provide a general overview of the contents of this disclosure. To the extent described in this background section, the works of the inventors currently named, and any manner of description that may not be recognized as prior art at the time of filing, are not, expressly or implicitly, considered prior art to this disclosure. [Overview of the Initiative]

[0007] The features describe a neurosurgical system for examining a patient's brain tissue for tumor tissue. The neurosurgical system includes a suction device configured to apply suction force to the patient's tissue. The suction device includes a suction cannula defining a lumen, an optical fiber coupled to the suction cannula and configured to transmit fluorescence emitted by the brain tissue, and an indicator coupled to the suction cannula and configured to selectively emit visible light. The visible light is different from the fluorescence transmitted by the optical fiber. The neurosurgical system also includes an excitation source configured to emit excitation light. The excitation light has a wavelength that induces fluorescence in tumor tissue. The neurosurgical system also includes an optical instrument 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 neurosurgical system also includes a controller coupled to the indicator and the optical instrument, which is configured to determine that the brain tissue is neoplastic based on the electrical signal and to activate the indicator based on the determination that the brain tissue is neoplastic.

[0008] The description includes a neurosurgical method for detecting whether a patient's brain tissue contains tumor tissue. The neurosurgical method is performed using a surgical system, which includes an aspirator with an optical fiber and an indicator coupled to it, an excitation source, an optical instrument coupled to the optical fiber, and a controller coupled to the excitation source, the optical instrument, and the indicator. The neurosurgical method includes the step of applying an aspiratory force to the patient's brain tissue using the aspirator. The neurosurgical method also includes the step of inducing fluorescence in the tumor tissue by emitting excitation light of a predetermined wavelength from the excitation source. The neurosurgical method also includes the step of collecting the fluorescence emitted from the brain tissue with an optical fiber. The neurosurgical method also includes the step of converting the fluorescence into an electrical signal using the optical instrument. The neurosurgical method also includes the step of activating an indicator based on the electrical signal using the controller when the controller determines that the electrical signal indicates that the brain tissue is tumorous.

[0009] The description includes a neurosurgical method for detecting whether target brain tissue is neoplastic in an operating room under ambient light conditions using a surgical system. The surgical system includes a working instrument comprising at least one optical fiber and an indicator, an optical instrument coupled to at least one optical fiber, an excitation source coupled to at least one optical fiber, and a controller connected to the optical instrument and indicator. The neurosurgical method for detecting target tissue includes the step of detecting fluorescence emitted from the target brain tissue during a surgical procedure. The step of detecting fluorescence includes emitting blue light from the excitation source to induce fluorescence emission from the target brain tissue. The step of detecting fluorescence also includes receiving the fluorescence from the target brain tissue from at least one optical fiber using the optical instrument. The step of detecting fluorescence also includes converting the fluorescence into an electrical signal using the optical instrument. The neurosurgical method also includes the step of determining, based on the electrical signal, that the target brain tissue is neoplastic using the controller. The neurosurgical method also includes the step of activating the indicator of the working instrument using the controller in response to the determination that the target brain tissue is neoplastic.

[0010] Further application areas of this disclosure will become apparent from the detailed description, claims, and drawings. The detailed description and specific examples are for illustrative purposes only and are not intended to limit the scope of this disclosure.

[0011] This disclosure will be better understood from the detailed description and accompanying drawings. [Brief explanation of the drawing]

[0012] [Figure 1] This chart shows the visibility of red fluorescence in tumor tissue as viewed through a surgical microscope, based on conventional teaching techniques. [Figure 2] This disclosure shows the neurosurgical system related to the teachings presented here. [Figure 3] A functional block diagram of the neurosurgical system relating to the teachings of this disclosure is shown. [Figure 4] An example of a suction device for a neurosurgical system related to the teachings of this disclosure is shown. [Figure 5A-5B] An example of a handle for a suction device in a neurosurgical system relating to the teachings of this disclosure is shown. [Figure 6] This disclosure shows an ultrasonic surgical system for neurosurgical systems related to the teachings of this disclosure. [Figure 7] This disclosure shows a tissue detection system for a neurosurgical system related to the teachings provided herein. [Figure 8] This diagram shows a functional block diagram of the tissue detection system for neurosurgical systems related to the teachings of this disclosure. [Figure 9A-9B] This document shows the optical system of the tissue detection system related to the teachings of this disclosure. [Figure 10A-10B] This diagram shows exploded views of some components of the optical system of the tissue detection system related to the teaching of this disclosure. [Figure 11] This diagram shows the internal workings of the control console of the tissue detection system related to the teachings of this disclosure. [Figure 12A] Sample elements of the tissue detection system related to the teachings in this disclosure are shown. [Figure 12B] Sample elements of the tissue detection system related to the teachings in this disclosure are shown. [Figure 12C] Sample elements of the tissue detection system related to the teachings in this disclosure are shown. [Figure 12D] Sample elements of the tissue detection system related to the teachings in this disclosure are shown. [Figure 12E] Sample elements of the tissue detection system related to the teachings in this disclosure are shown. [Figure 13] The excitation spectral signals generated by the spectrometer of the tissue detection system taught in this disclosure are shown. [Figures 14A-14B] The first and second modified spectral signals generated by the controller of the tissue detection system relating to the teaching of this disclosure are shown. [Figure 15] The Gaussian curve fitted to a second modified signal generated by the controller of the tissue detection system according to the teachings of this disclosure is shown. [Figure 16] Shows the PPIX intensity generated by the controller of the tissue detection system according to the teachings of the present disclosure. [Figure 17] Shows a flowchart of a surgical resection procedure performed using a neurosurgical system according to the teachings of the present disclosure. [Figures 18A-18B] Shows a sample element of a tissue detection system coupled to an ultrasonic handpiece assembly according to the teachings of the present disclosure. [Figures 19A-19B] Shows a sample element and an indicator element of tissue detection coupled to a bipolar forceps of a surgical system according to the teachings of the present disclosure. [Figure 20] Shows a sample element coupled to a suction device of a suction system with the jacket removed according to the teachings of the present disclosure. [Figure 21] Shows a sample element coupled to a suction device of a suction system according to the teachings of the present disclosure. [Figure 22] Shows a sample element coupled to a suction device of a suction system according to the teachings of the present disclosure. **DETAILED DESCRIPTION OF THE INVENTION**

[0013] In the drawings, reference numbers may be reused to identify similar and / or identical elements.

[0014] The inventors have recognized the need for a neurosurgical tumor resection system and / or method that can detect low levels of fluorescence under white light surgical conditions (i.e., without requiring a darkened or dimly lit operating room) during the process of removing tumors. There is also a need for a system that can shorten the time the target area is irradiated with excitation light in order to reduce the photobleaching effect. Furthermore, since an operating microscope cannot properly irradiate excitation light into deep cavities, there is a need for a system that can irradiate excitation light into deep cavities. Finally, since the discovery of undifferentiated lesions is essential for accurate histopathological diagnosis and optimal patient treatment, there is a need for a system that supports the intraoperative detection of undifferentiated lesions of this important tumor.

[0015] While this disclosure specifically discusses surgical procedures associated with the resection of target tissue of brain tumors by administration of 5-ALA to visualize the fluorescence of PPIX, the teachings of this disclosure can also be extended to other types of surgical procedures to detect other types of tissue and other types of fluorescent dyes (such as hypericin, Hexvix, and idocyanine green "ICG"). For example, ICG may be administered to help medical professionals visualize blood vessels during surgical procedures. ICG can bind to plasma proteins present in the blood. ICG is excited by near-infrared light and emits near-infrared light with a wavelength slightly longer than the near-infrared light that excited ICG.

[0016] Regarding Figure 1, Chart 10 shows the visibility of red fluorescence of PPIX as viewed through a surgical microscope. During brain tumor resection surgery, if the tumor resection is performed according to conventional systems (i.e., using a surgical microscope), there is a possibility of misinterpreting target tissue (i.e., tumor tissue) containing high concentrations of PPIX, resulting in a lower GTR. Therefore, it is clear that a more accurate method for detecting elevated PPIX concentrations would be very beneficial in helping to achieve a GTR. Hollow squares 40 indicate samples that do not produce visible fluorescence, and black squares 44 indicate samples that produce visible fluorescence. The y-axis represents the C threshold exceeding 0.1 μg / mL. PpIX This shows the accumulation level. The x-axis shows visible fluorescence (+F) and invisible fluorescence (-F) for healthy tissue and target tissue. Region 50 represents false negative regions where PPIX is present in the sample but did not produce visible light. In particular, sub-region 54 within region 50 contains samples with levels lower than 58 when viewed under a surgical microscope, but still C PpIX This is thought to include elevated level 62. Therefore, if medical professionals miss PPIX corresponding to subdomains, GTR will not be achieved.

[0017] Referring to Figure 2, a neurosurgical system 100 is provided that solves the shortcomings of the prior art. The neurosurgical system 100 may 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 is also called a navigation controller. A navigation interface operably communicates with the navigation computer 110. The navigation interface may include one or more input devices, which may be used to input information to the navigation computer 110 or to select / control specific aspects of the navigation computer 110. The navigation interface includes one or more displays 120. Such input devices may include interactive touchscreen displays / menus, keyboards, mice, microphones (voice-activated), gesture control devices, and the like.

[0018] The navigation computer 110 may be configured to store one or more preoperative or intraoperative images of the brain. Preoperative or intraoperative images of the brain can be provided using any suitable imaging device. For example, 2D, 3D, or 4D imaging devices such as isocentric fluoroscopy, biplane fluoroscopy, ultrasound, computed tomography (CT), multislice computed tomography (MSCT), magnetic resonance imaging (MRI), positron emission tomography (PET), and optical coherence tomography (OCT). Images can also be acquired and displayed in 2D, 3D, or 4D. In a more advanced form, a 4D surface rendering region of the body can also be achieved by incorporating patient data or other data from atlases or anatomical model maps, or from preoperative image data captured by MRI, CT, or echocardiography.

[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 a surgical microscope 108. For example, the display 120 can display an image corresponding to the field of view of the surgical microscope 108. If the navigation computer 110 may include two or more displays, one such display may show the field of view of the surgical microscope 108, and another such display may show a pre-operative or intraoperative image of the brain.

[0020] The tracking system 124 is coupled to the navigation computer 110 and is configured to sense the position of one or more tracking elements attached to a surgical instrument or patient. The tracking system 124 may be configured to track active or passive infrared tracking elements attached to a surgical instrument or patient. An example of a surgical navigation system 104 that may be used is the Nav3i®, commercially available from Stryker. The surgical navigation system 104 may have a variety of functions and features, such as those described in U.S. Patent No. 7,725,162 (B2) and U.S. Patent Application Publication No. 2020 / 0100849 (A1), which are incorporated herein by reference in their entirety.

[0021] The surgical microscope 108 includes one or more objective lenses configured to provide a range of magnification (e.g., about 2x to about 50x). The surgical microscope 108 may have a field of view having a predetermined range of area. The surgical microscope 108 is configured for fluorescence microscopy, for example, to detect PPIX. The surgical microscope 108 may include one or more excitation sources (e.g., excitation sources configured to emit light in the visible light spectrum, or excitation sources configured to emit light in the infrared spectrum) to irradiate brain tissue 111 with excitation light to cause PPIX to fluoresce. The surgical microscope 108 may also include a camera capable of detecting radiation at the fluorescence wavelength of PPIX or ICG.

[0022] The surgical cart 114 may include a surgical system 112, a suction system 113, a tissue detection system 116, and an ultrasonic surgical system 118. A display 121 may be coupled to the surgical cart and operably connected to the surgical system 112, the tissue detection system 116, and / or the ultrasonic surgical system 118 to display information associated with each respective system 112, 116, and 118. A medical professional can use the ultrasonic surgical system 118 and / or the surgical system 112 to excise targeted tissue from a patient's brain. The ultrasonic surgical system 118 may include an ultrasonic control console 128 and an ultrasonic handpiece assembly 130.

[0023] The suction system 113 may include a suction device 156 and a suction unit 117 for controlling various aspects of the suction device 156. A suction tube may connect the suction device 156 to the suction system 113. The suction system 113 may receive suction force from a vacuum source, such as a vacuum exhaust port in a medical facility. The suction system 113 may include one or more regulators or one or more regulating valves for controlling the suction pressure received from the vacuum source. The suction system 113 may also include one or more containers for storing waste collected by the suction device 156. In one example, the suction system 113 may correspond to a wall suction unit. In another example, the suction system 113 may correspond to a portable suction unit. The suction system 113 and the suction device 156 may have a variety of features, as described in U.S. Patent No. 9,066,658 and U.S. Patent Application Publication No. 20180344993, which are incorporated herein by reference in their entirety.

[0024] The surgical system 112 may include surgical instruments such as bipolar forceps 160 and a surgical control console 115 for controlling various aspects of the surgical instruments. Medical professionals may also use the surgical instruments to perform surgical procedures on tissue, for example, to excise or cauterize tissue. The bipolar forceps may have features as described in U.S. Patent No. 8,361,070(B2), which is incorporated herein by reference in whole. While this disclosure discusses and exemplifies that the surgical instruments may include bipolar forceps 160, the surgical system 112 and surgical instruments may include other instruments such as nerve stimulators, dissectors, or ablation devices (e.g., RF ablation devices and / or laser ablation devices). For example, the surgical system and / or surgical instruments may have various features as described in U.S. Patent No. 8,267,934, which is incorporated herein by reference in whole. Medical professionals may use any number of surgical systems and any number of surgical instruments when performing surgical procedures.

[0025] The tissue detection system 116 may include a control console 168 and a sample element 164 (shown as coupled to an ultrasonic handpiece assembly 130). The control console 168 can provide real-time instructions to a medical professional via the sample element 164 when brain tissue 111 corresponds to the target tissue. The sample element 164 may also be coupled to a bipolar forceps 160, a suction device 156, or other surgical instrument, as described in more detail below. The tissue detection system 116 determines when brain tissue 111 corresponds to the target tissue based on the fluorescence emitted by the target tissue, which is caused by a fluorescent dye. In one example, the fluorescent dye may correspond to PPIX. In another example, the fluorescent dye may correspond to ICG. Based on the intensity and wavelength of the fluorescence emitted by PPIX, as described in more detail below, the tissue detection system 116 can determine the presence of the target tissue.

[0026] Referring to Figure 3, a schematic diagram of the neurosurgical system 100 is shown. The tissue detection system 116 can perform similar functions to the surgical microscope 108 (i.e., enabling medical professionals to detect the presence of PPIX), but can be used in conjunction with the surgical microscope 108 to improve the outcome of tumor resection procedures and the likelihood of achieving GTR.

[0027] During the surgical procedure, the medical professional can first observe the patient's brain tissue 111 using a surgical microscope 108 under excitation light (e.g., blue light) to identify which portion of the brain tissue 111 corresponds to the target tissue indicated by red fluorescence. The medical professional can then switch the surgical microscope 108 to its original standard white light illumination for better visibility and begin the excision of the target tissue. Since the sample element 164 is attached to the suction device 156, the medical professional does not need to consider additional surgical instruments (i.e., optical probes, etc.) in a sterile field. The medical professional can perform the excision of the target tissue using bipolar forceps 160 in one hand and the suction device 156 in the other.

[0028] As a medical professional is excising 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 (described in more detail below) of the sample element 164. The tissue detection system 116 according to the teachings of this disclosure eliminates the need for the medical professional to switch back and forth between the various illumination settings of the surgical microscope 108 (i.e., illuminating the tissue with excitation light and white light) while excising target tissue. This is particularly important as the medical professional approaches the edge of the target tissue, as it is desirable for the medical professional to leave as much healthy tissue intact as possible while achieving GTR.

[0029] Referring to Figure 4, the suction device includes a suction cannula 157 and a handle 159. The suction cannula 157 defines a lumen for aspirating fluids, debris, and tissue from the patient. The handle 159 is tubular with a control section 167 which may be square. The distal end 162 may be tapered and configured to receive the proximal end 161 of the suction cannula 157. The distal end 165 of the handle 159 includes a vacuum fitting which may be configured to receive a suction tube 169 connected to a vacuum source that generates suction pressure. The vacuum fitting may be a standard barbed fitting, a quick-release fitting, or any other suitable fitting known in the art that allows the suction tube to be fluidly coupled to the vacuum source.

[0030] Referring further to Figures 5A and 5B, the control unit 167 may include a teardrop-shaped control unit 170 for adjusting the suction pressure. For example, if no part of the teardrop-shaped control unit 170 is covered by the medical professional, the suction pressure may be minimal, and if the teardrop-shaped control unit 170 is completely covered, the suction pressure may be maximum. Although the control unit 167 is described as including a teardrop-shaped control unit, the control unit 167 may also include other suitable inputs, such as buttons or control units of different shapes, to allow the medical professional to change the suction pressure. The control unit includes a through-hole 171 for receiving a sample element 164, as will be described in more detail below. The medical professional holds the suction device 156 from the handle 159 and manipulates the suction device 156 during the surgical procedure so that the distal end 163 contacts the patient's tissue to provide suction at the desired position. Although the suction device 156 is described as having a Fukushima configuration, other configurations such as a Frager configuration or a pool configuration are also possible.

[0031] Referring to Figure 6, the ultrasonic handpiece assembly 130 may comprise an ultrasonic handpiece 132 having a proximal end and a distal end. The ultrasonic handpiece assembly 130 may further comprise a sleeve 136 and an ultrasonic tip 140 which can be coupled to the distal end of the ultrasonic handpiece 132. The sleeve 136 may be configured to provide perfusion to the ultrasonic tip 140 and / or the surgical site. Furthermore, the sleeve 136 may be configured to provide suction to the ultrasonic tip 140. The ultrasonic tip 140 may comprise a cutting mechanism configured to excise, cut, shape, and / or remove biological tissue. The ultrasonic handpiece assembly 130 may have various features as described in U.S. Patent Nos. 6,497,715(B2), 6,955,680(B2), and 6,984,220(B2), which are incorporated herein by reference in their entirety, and in the brochure International Patent Publication No. 2020 / 068756A1.

[0032] The ultrasonic handpiece assembly 130 may also include a cable 144, or another power cord with a power connector 148 or adapter configured to connect the ultrasonic handpiece assembly 130 to a power source, such as an ultrasonic control console 128 configured to adjust various aspects of the ultrasonic handpiece assembly 130. The ultrasonic control console 128 may also be configured to adjust the perfusion and / or suction function of the ultrasonic handpiece assembly 130 and optimize the performance of the ultrasonic handpiece assembly 130 by performing perfusion and / or suction through one or more tubes (not shown) connected to the handpiece assembly 130. An example of an ultrasonic surgical system that may be used is commercially available from Stryker, including the Sonopet IQ ultrasonic aspirator. The ultrasonic control console 128 can control various operating parameters based on signals received from the tissue detection system 116.

[0033] Referring to Figures 7 and 8, the tissue detection system 116 includes a sample element 164 and a control console 168. The sample element 164 is connected to the control console 168 via a connector 172. The sample element 164 may include a detection fiber 264, an indicator element 296, and an electrode 266, which will be described in more detail below. The control console 168 may include a controller 204, a user interface 208, a power supply 212, an optical system 215, a microcontroller 220, and a mapping module 265. The optical system 215 may include an optical block 216, a spectrometer 224, an excitation source 228, and an optical connector 229. The function of each component will be described in more detail below.

[0034] The user interface 208 may include a display for showing the output from the controller 204. The user interface 208 may also include one or more inputs (e.g., push buttons, touch buttons, switches, etc.) configured for medical professional involvement. The power supply 212 can power various components of the control console 168. The control console 168 may include a probe port 173 to which the connector 172 of the sample element 164 is connected. The detection fiber 264 may then be connected to the optical block 216 via an optical connector 229. The control console 168 may also include an electrical port 174 for establishing communication links to the surgical system 112 and the ultrasonic surgical system 118. The control console 168 may also include an indicator port 175 for connecting to the indicator element 164, as will be described in more detail below.

[0035] The mapping module 265 may include a device configured to generate a stimulus signal for an electrode 266 configured to deliver the stimulus signal to the brain tissue 111. During surgical resection of target tissue, a medical professional may need to map the brain tissue 111 to determine which areas of the brain tissue 111 correspond to functionally important areas. For example, functionally important brain regions responsible for language or motor skills may be chosen to be avoided if, even if it is determined that the target tissue contains these areas, the target tissue cannot be removed without affecting the underlying function of those areas. The device may be configured to generate an electric current, which is then applied to the brain tissue 111 via the electrode by the medical professional. The electrode may be a standalone electrode positioned or coupled to the outer surface of the sample element 164, or the electrode may be incorporated within the sample element 164, as described in more detail below. The mapping module 265 and / or electrodes 266 may have a variety of functions and features, as described in International Patent Application Publication WO2021074265A1 and U.S. Patent No. 7,150,737(B2), which are incorporated herein by reference in their entirety. The controller 204 may be configured to generate alarms based on the results of the stimulation of the electrodes 266 to the brain tissue 111. For example, the controller 204 may generate alarms to be displayed on the user interface 208, display 120, or display 121. The alarms may indicate to a medical professional whether the brain tissue 111 corresponds to a functionally important area, such as an area related to motor or language function.

[0036] The excitation source 228 can irradiate the target tissue with excitation light via the detection fiber 264. The excitation source 228 may be configured to emit excitation light (e.g., blue light at approximately 405 nm, or blue light in the range of 400 nm to 500 nm). The excitation source 228 may also be configured to emit excitation light corresponding to other wavelengths, such as wavelengths related to the rest of the visible light spectrum other than blue light (e.g., above 500 nm but below 700 nm), wavelengths related to the ultraviolet light spectrum (below 400 nm), and / or wavelengths related to the infrared light spectrum (above 700 nm). The excitation source 228 may include any number of light sources, such as light-emitting diodes (LEDs), pulsed lasers, continuous-wave lasers, modulated lasers, and filtered white light sources.

[0037] In certain examples, the excitation source may be further configured to emit excitation light corresponding to a different wavelength than those described above. In this embodiment, the excitation sources may be referred to as a first excitation source 228 and a second excitation source, where the first excitation source 228 is configured to emit first excitation light at a predetermined wavelength in the visible light spectrum, and the second excitation source is configured to emit infrared light in a second wavelength range (e.g., 700 nm to 1 mm) corresponding to the infrared light spectrum. When two excitation sources are present, the first excitation source 228 may be configured to emit light that excites a first fluorescent dye such as PPIX, while the second excitation source may be configured to emit light that excites a second fluorescent dye such as ICG.

[0038] The controller 204 can control the operation of the excitation source 228. The controller 204 can control the operation of the excitation source 228 by changing its operating parameters. The operating parameters can correspond to time settings, power settings, or other appropriate settings. The time setting may include 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 described in more detail below.

[0039] The detection fiber 264 can be coupled to the optical connector 229. When the sample element 164 is coupled to a surgical instrument (i.e., an ultrasonic handpiece assembly 130, a suction device 156, or bipolar forceps 160), the distal end 272 of the detection fiber 254 is adjacent to the working portion of the surgical instrument, allowing the excitation light to be delivered to the target tissue.

[0040] Referring to Figures 9A and 9B, an optical block 216 is shown. An optical connector 229 may be coupled to the optical block 216. The optical block 216 may include an outer casing 274 calibrated in metal or other suitable material, which may completely enclose the components 232 of the optical block 216. Figure 7B shows the optical block 216 with the top end of the casing removed so that the components 232 of the optical block 216 are visible. The optical block 216 may be L-shaped and may include a first portion 280 and a second portion 284. An excitation source 228 may be coupled to the first portion 280 of the optical block 216. A spectrometer 224 may be coupled to the second portion 284 of the optical block 216.

[0041] Referring further to Figures 10A and 10B, exploded views of components 232 of the optical system 215 are shown, illustrating an optical path 285 for excitation light and an optical path 287 for light collected from brain tissue 111. The first part 280 may include an optical path 285 for excitation light to travel from one or more excitation sources 228 to brain tissue 111 via a detection fiber 264. The optical path 285 may be defined by components 232 within the first part 280 of the optical block. The second part 284 may include an optical path 287 for collected light to travel from brain tissue 111 to a spectrometer 224 via the detection fiber 264. The optical path 287 may be defined by components 232 within the second part 284 of the optical block. Components 232 of the optical block may be optical components such as one or more laser line filters and one or more long-pass filters. The optical block 216 may include one or more mirrors, lenses, optical connectors, optical fibers, and / or other suitable optical components.

[0042] In Figure 10A, the excitation source 228 emits excitation light that travels through one or more components 232, such as a laser line filter and / or a long-pass filter. The laser line filter or band-pass filter may be configured to remove unwanted noise (e.g., low-level transitions, plasma, and glow) generated by the excitation source 228. In other words, the laser line filter may be configured to remove excitation light or make the excitation light more monochromatic. The long-pass filter may be configured to reflect the light down the detection fiber 264 to the brain tissue 111. The excitation source 228 may be configured to deliver unfiltered excitation light (i.e., without filtering) to the target tissue via the detection fiber 264. The detection fiber 264 can guide the excitation light to the brain tissue 111 via the sample element 164.

[0043] The detection fiber 264 may be configured to collect light (i.e., fluorescence and ambient light) from the brain tissue 111. By coupling the sample element 164 to a surgical instrument, the distal end 272 will be adjacent to the working portion of the surgical instrument so that light can be collected from the target tissue.

[0044] Due to the presence of ambient and / or background light caused by various light sources in the operating room, such as a surgical microscope 108, a surgical lamp, or other equipment in the operating room, the light collected from the brain tissue 111 may include ambient and background light. Referring to Figure 10B, the light collected by the detection fiber 264 passes through components 232, such as a long-pass filter in the second part 284 of the optical block 216. After the light has passed through components 232, it can enter the spectrometer 224, which is coupled to the optical block 216.

[0045] The detection fiber 264 can be coupled to the optical connector 229. As will be described in more detail below, the distal end 272 of the detection fiber 264 may contain a lens or other transparent material so that the distal end 272 of the detection fiber 264 is adjacent to the working portion of the surgical instrument, so that excitation light can be delivered to the target tissue by coupling the sample element 164 to the surgical instrument when the sample element 164 is positioned on the surgical instrument (i.e., an ultrasonic handpiece, suction device, or bipolar forceps).

[0046] Referring to Figure 11, a diagram of the control console 168 with its outer casing removed is shown. The optical block 216 may be directly attached (e.g., via bolts) to the base 217 of the control console 168 to allow heat dissipation with respect to the heat generated by one or more components of the optical system 215. The control console 168 may contain sufficient space to allow multiple optical blocks 216 to be stacked inside the control console 168. For example, a second optical block with various optical components inside may be stacked on top of the optical block 216. A second excitation source may be coupled to the second optical block. The second optical block may include components that define the optical path for light generated by the second excitation source to reach the target tissue.

[0047] Referring to Figure 12A, a sample element 164 is shown. The sample element 164 may also include an indicator element 296. The indicator element 296 may include a transmission member 297 connected to an indicator 298. The indicator 298 may include one or more light-emitting diodes or another suitable light source. The indicator 298 is configured to emit light in response to the detection of tumor tissue or target tissue by the controller 204. The indicator 298 may be spherical, dome-shaped, cylindrical, or another suitable shape. A jacket 292 may surround a portion of the detection fiber 264 and a portion of the indicator element 296, specifically the transmission member 297. In other words, the jacket 292 may be terminated well before the distal end 272 of the detection fiber 264 leaves the transmission element 297, the indicator 298, and the detection fiber 264 at least partially exposed. The jacket 292 may be formed from one or another suitable material from among polyvinyl chloride, polyethylene, chlorinated polyethylene, and chlorosulfonated polyethylene / neoprene. Although not shown in Figure 12A, electrode 266 may be integrated with sample element 164. For example, the distal end of the electrode may be positioned adjacent to the distal end of the detection fiber 264 so that the distal end of electrode 266 can contact the brain tissue 111.

[0048] As described above, the detection fiber 264 can deliver 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 that light to the optical system 215, thereby supplying the filtered optical signal to the spectrometer 224.

[0049] The sample element 164 can be coupled to any surgical instrument (i.e., the ultrasonic handpiece assembly 130, the suction device 156, or the bipolar forceps 160) such that the distal end 272 of the detection fiber 264 is proximal to the working portion of the surgical instrument. The distal end 272 of the detection fiber 264 may include a lens, collimator, or another suitable optical component that allows the detection fiber 264 to deliver excitation light to the brain tissue 111 and to collect light from the brain tissue 111.

[0050] In this example, the detection fiber 264 functions to deliver excitation light to the tissue and collect light from the tissue, but the system may instead include 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 and any other fibers described herein are thought of as single fibers for simplicity, but it is understood that each fiber may contain two or more fibers. For example, the detection fiber 264 may include a bundle of detection fibers all connected in a manner similar to the single-fiber connection described above. In another example, the detection fiber 264 may include any number of fibers connected in series.

[0051] Referring to Figure 12B, a second alternative configuration of sample element 164 is shown. The illustrated sample element 164' is functionally equivalent to the sample element 164 shown in Figure 12A, and therefore a detailed description of the functionally equivalent parts is omitted. The illustrated indicator 298' is cylindrical, in contrast to the spherical indicator 298 shown in Figure 12A.

[0052] Referring to Figure 12D, a third configuration of sample element 164 is shown. The illustrated sample element 164'' is functionally equivalent to sample elements 164 and 164' shown in Figures 12A and 12B, and therefore a detailed description of the functionally equivalent parts is omitted here. In this configuration, the indicator element 296' is provided separately from sample element 164' (i.e., the indicator element 296 is not integrated with sample element 164'). The indicator element 296''' may include a transmission member 297' such as a jacketed wire and / or cable, an indicator 298, and a connector 299 for connecting the transmission member 297 to the indicator port 175 of the control console 168. The indicator element 296 may include a connector 299 for connecting the indicator element 296 to the indicator port 175 of the control console 168.

[0053] Referring to Figure 12E, a fourth configuration of sample element 164 is shown. The illustrated sample element 164''' is functionally equivalent to sample elements 164, 164', and 164'' shown in Figures 12A, 12B, and 12D, and therefore a detailed description of the functionally equivalent parts is omitted here. Here, the transmission member 297''' and indicator 298 of indicator element 296''' can be replaced with an optical fiber, which will be referred to below as an indicator fiber. The indicator fiber functions to emit light in response to detection of target tissue by the controller 204. Sample element 164''' may also include an indicator portion 291 that is illuminated by the indicator fiber as light travels down sample element 264'''. The indicator portion 291 may be located proximal to the distal portion of sample element 164 so that the indicator portion 291 can be seen by a medical professional when excising tissue. The indicator portion 291 may be transparent or may correspond to a removed portion of the jacket 292 of sample element 164. The indicator fiber is coupled to the optical block 216 via an optical connector and can receive light of a different wavelength from the excitation light from the excitation source 228 or another excitation source. For example, the excitation source can generate green light (e.g., wavelength of approximately 520–564 nm) when instructed by the controller 204 to indicate the detection of target tissue.

[0054] The sample element 164''' may include a coaxial fiber having a central core and an outer channel covered by a jacket 292. The detection fiber 264''' may be located within the central core, while the indicator fiber is located within the outer channel. A portion of the jacket 292 of the sample element 164''' may be removed to allow the indicator fiber to illuminate the indicator portion 291 by illuminating it with light through the sidewall of the outer channel.

[0055] The controller 204 can transmit an activation signal to the indicator 298 in response to the detection of target tissue. The indicator 298 can emit light in response to the reception of the activation signal. The controller 204 can control the LED to emit light of various colors depending on whether the controller 204 detects PPIX or ICG (i.e., whether the brain tissue 111 corresponds to target tissue or blood vessels). For example, the controller 204 can control the LED to emit green light (e.g., wavelength of approximately 520-564 nm) if PPIX exceeding a threshold is detected, or yellow light (e.g., wavelength of approximately 565-590 nm) if ICG is detected.

[0056] The spectrometer 224 is configured to convert filtered optical signals (i.e., filtered light) into spectral signals in the form of electrical signals. The microcontroller 220 is configured to control the operation of the spectrometer 224. Examples of spectrometer systems that can be used are commercially available from Hamamatsu, including the Mini Spectrometer Micro Series C12880MA. Although the spectrometer 224 is intended throughout this disclosure, other optical instruments may be used instead of the spectrometer 224. The spectrometer 224 may include an entrance slit, a collimating lens / mirror, a transmission diffraction grating element, a focusing mirror, and an image sensor. The entrance slit receives light collected from the optical block 216, and the light then passes through the collimating lens / mirror. The collimating lens / mirror collimates the collected light that has passed through the entrance slit and directs it to the diffraction grating element. The diffraction grating element separates the incident light from the collimating lens into different wavelengths, allowing each wavelength of light to pass or reflect at different diffraction angles. A focusing lens or mirror forms an image of light dispersed by wavelength by a diffraction grating element onto pixels arranged linearly on an image sensor according to wavelength.

[0057] Each wavelength is photoelectrically converted into an electrical signal (spectral signal). The image sensor outputs a signal of light incident on each pixel at regular time intervals (i.e., the image sensor converts the optical signal into an electrical signal and outputs it). This time interval is sometimes called the integration timing. The microcontroller 220 may be configured to control the integration timing based on the operation of the spectrometer 224, for example, based on instructions from the controller 204. The microcontroller 220 transmits the spectral signal to the controller 204 via a communication interface (e.g., a serial peripheral interface (SPI)).

[0058] The controller 204 is configured to convert the spectral signal supplied by the microcontroller 220 into a simple / usable output variable in real time to provide medical professionals with an indication of the presence of target tissue within a sterile field. The controller 204 can illuminate the indicator 298 of the sample element 164 in response to the detection of target tissue.

[0059] Since ambient light is present in the optical signal collected in the target tissue and therefore may be present in the spectral signal supplied by the spectrometer 224, the controller 204 is configured to perform one or more control functions or control methods to remove ambient light from the spectral signal (i.e., wavelengths related to ambient light) to accurately detect when the brain tissue 111 corresponds to the target tissue as evidence by PPIX present in the target tissue.

[0060] The controller 204 may be configured to remove ambient light from the spectral signal in any suitable manner using any suitable method, function, or algorithm. In one example, the controller 204 may pulse one or more excitation sources 228. The controller 204 may be configured to pulse the excitation sources 228 so that an alternating spectral signal is collected. During a first period, the controller 204 may operate the excitation source 228 in a first irradiation state (IS1) in which the excitation source 228 is on and irradiating the target tissue via the detection fiber 264. During a second period, the controller 204 may be configured to operate the excitation source 228 in a second irradiation state (IS2) in which the excitation source 228 is off and not irradiating the target tissue via the detection fiber 264.

[0061] The spectral signal produced as a result of the optical signal collected from the target tissue while the excitation source 228 is in a first irradiation state (IS1) during the first period, supplied by the spectrometer 224, should contain red fluorescence when the brain tissue 111 corresponds to the target tissue. The spectral signal received by the controller 204 during the first period while the excitation source 228 is in the first irradiation state (IS1) may henceforth be referred to as the excitation spectral signal. Referring to Figure 13, the excitation spectral signal 356 corresponding to the red fluorescence collected during the first period is shown. Due to the presence of ambient and / or background light caused by various light sources in the operating room, such as the surgical microscope 108, surgical lamp, or any other device in the operating room, the excitation spectral signal 356 exhibits a wide range of wavelengths present in addition to the wavelength associated with red fluorescence. Referring to Figure 10B, the light collected by the detection fiber 264 passes through components 232, such as the long-pass filter of the second part 284 of the optical block 216. After the light passes through component 232, it can enter the spectrometer 224, which is coupled to optical block 216.

[0062] The spectral signal generated as a result of the optical signal supplied by the spectrometer 224 and collected from the target tissue while the excitation source 228 is in the second irradiation state (IS2) may include ambient light and should not include red fluorescence produced by the target tissue, even though the excitation light needs to be absorbed by the target so that the tissue fluoresces. The spectral signal received by the controller 204 during the second period while the excitation source 228 is in the second irradiation state (IS2) may be called the ambient spectral signal.

[0063] Referring to Figures 14A and 14B, the first modified spectral signal 360 and the second modified spectral signal 368 of the target tissue are shown. Fluorescence intensity is shown on one axis, and emission wavelength is shown on the other axis. The controller 204 may be configured to generate the first modified spectral signal 360 in any suitable manner to exclude ambient light (i.e., ambient spectral signal) from consideration. For example, the controller 204 may be configured to subtract the ambient spectral signal from the excitation spectral signal (i.e., subtract the spectral signal supplied over the second irradiation state (IS2) from the spectral signal supplied over the first irradiation state (IS1)). After the first modified spectral signal 360 is generated, the controller 204 may be configured to further subtract any background signals that are still present from the first modified spectral signal 360.

[0064] The controller 204 may be configured to generate a second modified spectral signal by subtracting background signals still present in the first modified spectral signal. For example, the controller 204 may be configured to use a polynomial-based algorithm, such as an automatic polynomial fitting routine based on a modified version of a least-squares polynomial, to obtain a baseline curve 364 representing any background signals still present. The controller 204 using the algorithm can then subtract the baseline curve 364 from the first modified spectral signal 360 to obtain a second modified spectral signal 368 representing the red fluorescence emitted from the target tissue with ambient and background light removed.

[0065] Controller 204 may be configured to fit at least one Gaussian distribution / curve to the spectral signal. Controller 204 can fit at least one Gaussian distribution to the raw spectral signal (i.e., the excitation spectral signal and / or ambient spectral signal), a first modified spectral signal, or a second modified spectral signal. This may allow for the determination of a confidence level based on the fitting results. In Figure 15, three Gaussian curves (372, 376, 380) were fitted to the remaining three spectral bands of the second modified spectral signal 368 (i.e., the spectral signal remaining after ambient and background light have been removed).

[0066] Referring to Figure 16, the controller 204 may be configured to select a Gaussian band fitted to the emission band of PPIX (i.e., the band including 635 nm) and to generate a selected band 372 for display in real time so that a medical professional can see the PPIX intensity in real time when the sample element 164 collects the sample. The controller 204 may store predetermined intensity thresholds associated with the target tissue.

[0067] The controller 204 may be configured to generate an activation signal based on a comparison between the PPIX intensity in a PPIX emission band fitted to the Gaussian band and a predetermined intensity threshold. When the PPIX intensity exceeds the threshold, the controller 204 can generate an activation signal. Based on the activation signal, the indicator 298 of the sample element 164 emits light, thereby providing medical professionals with a real-time indication of the presence of target tissue.

[0068] The controller 204 may be configured to perform an error correction process before generating an actuation signal. During the error correction process, the controller 204 may be configured to determine the ratio of any of the spectral signals (raw spectral signal, excitation spectral signal, ambient spectral signal, first corrected spectral signal, or second corrected spectral signal) to a Gaussian band, such as a Gaussian band fitted to the PPIX emission band. The controller 204 may be configured to calculate at least two full width at half maximum (FWHM) points in the Gaussian band. The controller 204 may be configured to calculate how far the at least two FWHM points are from any of the spectral signals (as a percentage of their intensity). If the ratio exceeds a threshold (e.g., 2 percent), the controller 204 may be configured to return that the PPIX intensity has fallen below the threshold, and therefore the controller 204 does not generate an actuation signal, even if an actuation signal would have been generated before the error correction process was performed.

[0069] The controller 204 can communicate with the ultrasound surgical console via a communication link established through the electrical port 174. For example, the communication link can be established by plugging a cord into the electrical port and also into the ultrasound control console 128. The communication link can also be established wirelessly. The controller 204 can notify the ultrasound control console 128 based on the type of tissue detected. The controller 204 can notify the ultrasound control console 128 when target tissue is present or absent. Based on the information provided by the controller 204, the ultrasound control console 128 can adjust one or more operating parameters. For example, if target tissue is present, the excision ratio may not be limited, but if target tissue is absent, the excision ratio may be limited so as to prevent the ultrasound surgical handpiece from cutting healthy tissue. In such cases, the ultrasound console can control drive signals such as voltage, current, or both supplied to the ultrasound handpiece based on whether target tissue is detected. In this example, the controller 204 can communicate with the ultrasound control console 128, but instead, the controller 204 may communicate with the surgical control console 115 to control various surgical instruments (e.g., bipolar forceps 160, nerve stimulator, dissector, ablation device, etc.) based on the presence or absence of target tissue.

[0070] The controller 204 may be configured to perform one or more standardization routines and / or calibration routines. The controller 204 prompts a medical professional via the user interface 208 to perform a calibration routine at the start of the resection procedure, taking into account human-induced variations in the autofluorescence of brain tissue 111. The controller 204 can instruct a medical professional to collect light from known healthy brain tissue 111 using the detection fiber 264 of the sample element 164 for use as a standard baseline. Based on the characteristics of the collected light, the controller 204 can adjust one or more parameters of an algorithm for determining whether the brain tissue is neoplastic, such as a predetermined intensity threshold in PPIX.

[0071] In the standardization routine, during the first period, the controller 204 can instruct the medical professional to collect light from a light source (e.g., nearby light) that emits light from a consistent spectral band using the detection fiber 264 of the sample element 164. After the optical system 215 converts the collected light into an electrical signal (hereinafter referred to as the first standardized electrical signal), the controller 204 can store the first standardized electrical signal that represents the characteristics of the collected light. During the second period that occurs after the first period, the controller 204 can instruct the medical professional to collect light from the same light source. After the optical system 215 converts the collected light into a second standardized signal, the controller 204 can compare the first standardized signal obtained during the first period with the second standardized signal obtained during the second period and use the results to account for any variation in the optical reading over time. For example, the controller 204 may adjust one or more parameters of the algorithm used to determine whether brain tissue is neoplastic or one or more settings of the spectrometer 224 to account for any variation in the optical reading over time.

[0072] Figure 17 includes a flowchart 400 illustrating a surgical resection procedure relating to the teachings of this disclosure. As will be apparent from the following description, this flowchart represents only a typical and non-limiting sequence of blocks to illustrate a typical resection procedure performed to resect target tissue, and is not intended to function as a complete functional block diagram of all steps of the resection procedure.

[0073] The excision procedure 400 begins in 404, in which a medical professional can identify the target tissue using a surgical microscope 108 under excitation light. In 408, after the target tissue has been identified, the medical professional can perform the excision of the target tissue using one of the aforementioned surgical instruments. In 412, after the excision of the target tissue identified via the surgical microscope, the medical professional determines whether there is any suspected brain tissue that may correspond to the target tissue (for example, tissue that does not emit visible light when viewed through the surgical microscope 108 under excitation, but has properties related to the target tissue). If no suspected brain tissue is present, the excision procedure may be terminated; otherwise, the excision procedure proceeds to 416.

[0074] At 416, the medical professional engages a sample element 164 with the suspected brain tissue (for example, to excite the brain tissue and collect light from the brain tissue). At 420, the medical professional determines whether the tissue contains PPIX as evidenced by the indicator 298 on the sample element 164. If so, the excision procedure proceeds to 424; otherwise, the excision procedure returns to 412 and continues. At 424, the medical professional applies electrical stimulation to the target tissue. At 428, the medical professional determines whether the electrical stimulation has affected the patient. If so, the medical professional may choose not to excise the target tissue; otherwise, the excision procedure returns to 408 and continues.

[0075] Referring to Figures 18–21, the sample element 164 can be attached to any surgical instrument. The sample element 164 may be attached to the ultrasonic handpiece assembly 130 as shown in Figures 18A and 18B, to the bipolar forceps 160 (or any surgical instrument associated with the surgical system 112 such as a dissector) as shown in Figures 19A and 19B, or to the suction device 156 as shown in Figures 20–22. The sample elements 164 and 164' and / or the indicator element 296 can be attached to the surgical instrument in any suitable manner. For example, the sample element 164 (or the sample element 164'' and the indicator element 296'') can be attached to the surgical instrument via an adhesive. The adhesive may be in the form of a substance such as a sticker or glue. In addition to or instead of the above, sample element 164 (or sample element 164'' and indicator element 296'') may also be attached to the surgical instrument via a fixing element described in more detail with respect to Figure 22, or via a jacket described in more detail with respect to Figures 21 and 22.

[0076] As shown in Figure 18B, the sample element 164''' can be coupled to the ultrasonic handpiece assembly 130 in any manner, as long as there is no direct contact between the tip 140 and the distal portion of the sample element 164'''. For example, the sample element 164''' can be terminated at a portion of the sleeve 136 close to the tip 140. In another example, the sample element 164''' can extend beyond the sleeve 136, but may be positioned so that there is sufficient empty space between the tip 140 and the sample element 164''' to prevent contact between the tip 140 and the sample element 164'''.

[0077] In the configuration shown in Figures 19A and 19B, the sample element 164'' is shown attached to the outer portion of the first pincer 302 of the bipolar forceps 160, and the indicator element 296'' is shown attached to the inner portion of the second pincer 304 of the bipolar forceps 160. As shown, the indicator is positioned near the tip of the second pincer, so that the medical professional can see the indicator 298'' without looking at another screen or part of the instrument when excising the target tissue.

[0078] Referring to Figures 20 and 21, the sample element 164 is shown coupled to the suction device 156. The detection fiber 264 and a portion of the indicator element 296 (i.e., the transmission element 297 and indicator 298) can be guided through the through-hole 171 of the handle 159. The distal end 272 of the detection fiber 264 may be located proximal to the distal end of the suction cannula 257. The indicator 298 may be located near the distal end of the detection fiber 264, but proximal to the distal end 162 of the control portion 167 of the handle 159 than the position of the distal end 272 of the detection fiber. In other words, the distal end 162 of the detection fiber 264 may be located proximal to the distal end of the suction cannula 157 than the position of the indicator 298. Referring further to Figure 21, after the detection fiber 264 and a portion of the indicator element 296 have been supplied through the through-hole 171, the jacket 306 can be mounted over the suction cannula 157, the detection fiber 264, and the transmission element 297. The jacket 306 may be fitted onto the distal end 162 of the handle 159 so as to cover the distal end 162 and the through-hole 171. The jacket 306 may be terminated just before the indicator 298 is coupled to the suction cannula 157. The detection fiber 264 may protrude from beneath the jacket 306 so as not to obstruct the delivery of excitation light or the collection of fluorescence from the tissue. Also, as shown, the indicator 298 may be fully exposed but partially covered by the jacket 306. In some configurations, the jacket 306 may be omitted.

[0079] Referring to Figure 22, different configurations of the suction tube 156' are shown. Specifically, the suction tube 156' does not include a through-hole in the handle 159' of the suction tube 156'. Instead, the sample element 164'' is coupled to the suction device 156' via a fixing element 308. Specifically, the sample element 164'' is shown to be coupled to the suction cannula 157' by two fixing elements. Although only two fixing elements 308 are illustrated, three or more fixing elements 308 can be used to coupled the sample element 164 to the suction cannula 157' or the handle 159'. The fixing elements 308 may include clips, bands, or anything that can secure the sample element 164 to the suction device 156'.

[0080] Clause

[0081] Clause 1 - An ultrasonic surgical system comprising: an ultrasonic handpiece assembly configured to remove brain tissue; a sample element comprising at least one fiber coupled to the ultrasonic handpiece assembly and configured to collect fluorescence emitted from brain tissue; an indicator coupled to the ultrasonic handpiece assembly and configured to selectively emit light; and a controller configured to detect the type of brain tissue based on fluorescence, activate the indicator based on the detected type of brain tissue, and control the ultrasonic handpiece assembly based on the detected type of brain tissue.

[0082] Clause 2 - The ultrasonic surgical system of Clause 1, wherein at least one fiber is coupled to an excitation source, and at least one fiber is configured to irradiate excitation light from the excitation source to induce fluorescence emitted from brain tissue and collect the fluorescence.

[0083] The ultrasonic surgical system of Clause 3 further comprises an optical system coupled to a controller and a sample element, the optical system comprising an excitation source and an optical detection system configured to convert fluorescence into an electrical signal, and the controller detecting the type of brain tissue from the electrical signal.

[0084] Clause 4 - The ultrasonic surgical system of Clause 3, wherein an excitation source is further defined as a first excitation source, fluorescence is further defined as a first fluorescence, an electrical signal is further defined as a first electrical signal, and the optical system further includes a second excitation source, wherein at least one fiber is configured to irradiate a second excitation light from the second excitation source to induce a second fluorescence emitted from brain tissue and collect the second fluorescence, the optical detection system is configured to convert the second fluorescence into a second electrical signal, and the controller is configured to determine a second type of brain tissue from the second electrical signal.

[0085] Clause 5 - The controller is configured to detect the type of brain tissue based on an algorithm, as per the ultrasonic surgical system of Clause 3.

[0086] Clause 6 - The ultrasound surgical system of Clause 5, including a calibration routine to be performed with respect to healthy tissue or baseline parameters.

[0087] Clause 7 - The ultrasonic surgical system of Clause 5, wherein the algorithm is configured to calculate a modified electrical signal by fitting a baseline polynomial curve to the electrical signal, and to subtract the baseline polynomial curve from the electrical signal to remove ambient light.

[0088] Clause 8 - The ultrasonic surgical system of Clause 7, wherein the algorithm includes fitting at least one Gaussian distribution to the modified electrical signal.

[0089] Clause 9 - The ultrasonic surgical system of Clause 5, wherein the controller is configured to periodically switch the excitation source on and off, the sample element is configured to collect ambient light when the excitation source is off and not illuminating brain tissue with fluorescence, the sample element is configured to collect ambient light and fluorescence when the excitation source is on and the sample element is illuminating brain tissue with fluorescence, and the algorithm includes subtracting ambient light from fluorescence.

[0090] The ultrasonic surgical system of Clause 10 - an ultrasonic handpiece assembly comprising an ultrasonic handpiece and a sleeve, wherein the indicator is coupled to the sleeve.

[0091] Clause 11 - The ultrasonic surgical system of Clause 1, further comprising electrodes configured to apply electrical stimulation to brain tissue, wherein a controller generates an alarm when the electrical stimulation elicits a predetermined response from the patient.

[0092] Clause 12 - A surgical system comprising: a surgical instrument configured to remove brain tissue; a sample element coupled to the surgical instrument and comprising at least one fiber configured to (i) collect fluorescence emitted from brain tissue; an indicator coupled to the surgical instrument and configured to selectively emit light; and a controller configured to detect the type of brain tissue based on fluorescence, activate the indicator based on the detected type of brain tissue, and control the surgical instrument based on the detected type of brain tissue.

[0093] Clause 13 - The surgical system of Clause 12, further comprising an optical system coupled to a controller and a sample element, the optical system including an excitation source coupled to at least one fiber, the at least one fiber configured to irradiate brain tissue with excitation light from the excitation source to induce fluorescence emitted from brain tissue and collect the fluorescence, and an optical detection system configured to convert the fluorescence into an electrical signal, the controller detecting the type of brain tissue from the electrical signal.

[0094] The surgical system of Clause 14 - wherein an excitation source is further defined as a first excitation source, fluorescence is further defined as a first fluorescence, an electrical signal is further defined as a first electrical signal, and the optical system further includes a second excitation source, wherein at least one fiber is configured to irradiate a second excitation light from the second excitation source to induce a second fluorescence emitted from brain tissue and collect the second fluorescence, the optical detection system is configured to convert the second fluorescence into a second electrical signal, and the controller is configured to determine a second type of brain tissue from the second electrical signal.

[0095] Clause 15 - The surgical system of Clause 13, wherein the controller is configured to detect the type of brain tissue based on an algorithm.

[0096] Clause 16 - The surgical system of Clause 15, including a calibration routine to be performed with respect to healthy tissue or baseline parameters.

[0097] Clause 17 - The surgical system of Clause 15, wherein the algorithm is configured to calculate a modified electrical signal by fitting a baseline polynomial curve to the electrical signal, and to subtract the baseline polynomial curve from the electrical signal to remove ambient light.

[0098] Clause 18 - The surgical system of Clause 17, wherein the algorithm includes fitting at least one Gaussian distribution to the modified electrical signal.

[0099] Clause 19 - The surgical system of Clause 15, wherein the controller is configured to periodically switch the excitation source on and off, the sample element is configured to collect ambient light when the excitation source is off and not illuminating brain tissue with fluorescence, and the sample element is configured to collect ambient light and fluorescence when the excitation source is on and the sample element is illuminating brain tissue with fluorescence, and the algorithm includes subtracting ambient light from fluorescence.

[0100] Clause 20 - The surgical system of Clause 12, wherein the surgical instruments include bipolar forceps.

[0101] Clause 21 - A surgical system according to Clause 12, wherein the surgical instruments include a nerve stimulator.

[0102] Clause 22 – A surgical system according to Clause 12, wherein the surgical instruments include nerve dissectors.

[0103] Clause 23 - A surgical system according to Clause 12, wherein the surgical instruments include an ablation device.

[0104] Clause 24 - The surgical system of Clause 12, wherein the controller is configured to control the surgical instruments by adjusting the operating parameters of the surgical instruments based on the detection of the type of brain tissue.

[0105] Clause 25 - The surgical system of Clause 12, further comprising electrodes configured to apply electrical stimulation to brain tissue.

[0106] Clause 26 - The surgical system of Clause 25, wherein the controller generates an alarm when electrical stimulation elicits a predetermined response from the patient.

[0107] Clause 27 - A surgical aspiration system comprising: a suction device configured to apply suction force to brain tissue; a sample element including at least one optical fiber coupled to the suction device and configured to collect fluorescence emitted from brain tissue; an indicator coupled to the suction device and configured to selectively emit light; and a controller configured to detect the type of brain tissue based on fluorescence and to activate the indicator according to the detected type of brain tissue.

[0108] Clause 28 - The surgical aspiration system of Clause 27, wherein at least one optical fiber is coupled to an excitation source, and at least one fiber is configured to irradiate excitation light from the excitation source to induce fluorescence emitted from brain tissue and collect the fluorescence.

[0109] The surgical aspiration system of Clause 29 further comprises an optical system coupled to a controller and a sample element, the optical system comprising an excitation source and an optical detection system configured to convert fluorescence into an electrical signal, and the controller detecting the type of brain tissue from the electrical signal.

[0110] Clause 30 - The surgical aspiration system of Clause 29, wherein an excitation source is further defined as a first excitation source, fluorescence is further defined as a first fluorescence, an electrical signal is further defined as a first electrical signal, and the optical system further includes a second excitation source, wherein at least one fiber is configured to irradiate a second excitation light from the second excitation source to induce a second fluorescence emitted from brain tissue and collect the second fluorescence, the optical detection system is configured to convert the second fluorescence into a second electrical signal, and the controller is configured to determine a second type of brain tissue from the second electrical signal.

[0111] Clause 31 - The surgical aspiration system of Clause 29, wherein the controller is configured to detect the type of brain tissue based on an algorithm.

[0112] Clause 32 - The surgical aspiration system of Clause 31, including a calibration routine to be performed with respect to healthy tissue or baseline parameters.

[0113] Clause 33 - The surgical aspiration system of Clause 31, wherein the algorithm is configured to calculate a modified electrical signal by fitting a baseline polynomial curve to the electrical signal, and to subtract the baseline polynomial curve from the electrical signal to remove ambient light.

[0114] Clause 34 - The surgical aspiration system of Clause 33, wherein the algorithm includes fitting at least one Gaussian distribution to the modified electrical signal.

[0115] Clause 35 - The surgical aspiration system of Clause 31, wherein the controller is configured to periodically switch the excitation source on and off, the sample element is configured to collect ambient light when the excitation source is off and not illuminating brain tissue with fluorescence, and the sample element is configured to collect ambient light and fluorescence when the excitation source is on and the sample element is illuminating brain tissue with fluorescence, and the algorithm includes subtracting ambient light from fluorescence.

[0116] Clause 36 - The surgical aspiration system of Clause 27, further comprising electrodes configured to apply electrical stimulation to brain tissue, wherein a controller generates an alarm when the electrical stimulation elicits a predetermined response from the patient.

[0117] Clause 37 - The surgical suction system of Clause 27, wherein the suction device includes a handle portion and an elongated portion, and the sample element is coupled to the elongated portion.

[0118] Clause 38 - A method for detecting target tissue under ambient light conditions in an operating room, comprising the steps of: positioning an optical fiber within a sterile field including brain tissue illuminated by ambient light; collecting fluorescence emitted from the brain tissue with the optical fiber; detecting target tissue in the brain tissue based on fluorescence emitted from the brain tissue using a controller coupled to the optical fiber; and activating an indicator positioned within the sterile field to provide a visual alarm in response to the detection of target tissue.

[0119] Clause 39 - The method of Clause 38, wherein fluorescence is emitted from brain tissue in response to irradiation of brain tissue with excitation light from an excitation source coupled to an optical fiber.

[0120] Clause 40 - The method of Clause 39, which is algorithm-based in detecting fluorescence emitted from target tissue during a surgical procedure.

[0121] Clause 41 - The method of Clause 40, wherein the algorithm includes a calibration routine to be performed with respect to healthy tissue or baseline parameters.

[0122] The method of Clause 40, further comprising an optical system coupled to an optical fiber and a controller, wherein the optical system is configured to convert fluorescence collected from a target tissue into an electrofluorescence signal.

[0123] Clause 43 - The method of Clause 42, wherein the optical system includes a spectrometer.

[0124] Clause 44 - The method of Clause 42, wherein the algorithm includes fitting a baseline polynomial curve to the electrofluorescence signal and calculating a modified electrofluorescence signal by subtracting the baseline polynomial curve from the electrofluorescence signal to remove ambient light.

[0125] Clause 45 - The method of Clause 44, wherein the algorithm includes fitting at least one Gaussian distribution to the modified electrofluorescence signal.

[0126] Clause 46 - The method of Clause 40, further comprising the steps of periodically turning excitation light from an excitation source on and off, and collecting ambient light using an optical fiber when the excitation light is off and the brain tissue is not illuminated by the excitation light, wherein the algorithm includes subtracting ambient light from fluorescence.

[0127] Clause 47 - The method of Clause 38, wherein the optical fiber is incorporated into at least one of the surgical instruments and standalone devices.

[0128] Clause 48 - The method of Clause 38, wherein the indicator comprises a light-emitting device that is coupled to a surgical instrument.

[0129] Clause 49 - A method for detecting target tissue in an operating room under ambient light conditions using a surgical system, wherein the surgical system comprises a working instrument including at least one optical fiber, an indicator, an optical system coupled to the working instrument, and an excitation source coupled to at least one optical fiber, the method for detecting target tissue comprising: positioning the working instrument in a sterile field including brain tissue illuminated by ambient light; and using the optical system to detect fluorescence emitted from the target tissue during a surgical procedure using at least one optical fiber of the working instrument, the step of detecting fluorescence comprising: irradiating the tissue with blue light from an excitation source using at least one optical fiber; collecting ambient light and fluorescence using at least one optical fiber; generating a fluorescence signal based on fluorescence emitted from the target tissue with ambient light removed; determining the presence of target tissue based on the detected fluorescence; and activating the indicator of the working instrument in response to the detection of target tissue.

[0130] Clause 50 - A method for detecting a target tissue according to Clause 49, wherein the step of irradiating the tissue with blue light from an excitation source using at least one optical fiber is performed over a first period, the step of irradiating the tissue with blue light is not performed over a second period, the step of collecting ambient light and fluorescence is performed over a first period, and the step of detecting fluorescence further includes the steps of (i) generating a first signal based on the ambient light and fluorescence collected during the first period, and (ii) generating a second signal based on the ambient light collected during the second period, wherein ambient light is removed from the fluorescence signal using an algorithm based on the first signal and the second signal.

[0131] Clause 51 - A method for detecting the target tissue of Clause 50, comprising the algorithm of calculating a baseline curve using a least-squares polynomial based on the difference between a first signal and a second signal.

[0132] Clause 52 - An algorithm for detecting a target tissue according to Clause 51, comprising subtracting a baseline curve from the difference between a first signal and a second signal in order to obtain a fluorescence signal.

[0133] Clause 53 - A method for detecting a target tissue according to Clause 52, comprising calculating at least one Gaussian curve with respect to at least one spectral band of a fluorescence signal.

[0134] Clause 54 - A method for detecting the target tissue of Clause 49, wherein the working instrument is a suction handle.

[0135] Clause 55 - A method for detecting the target tissue of Clause 49, wherein the working instrument is an ablation device.

[0136] Clause 56 - A method for detecting target tissue according to Clause 55, further comprising the step of removing the target tissue based on an indicator using a working instrument.

[0137] Clause 57 - A method for detecting target tissue according to Clause 49, wherein ambient light includes light generated by a surgical microscope and light generated by one or more surgical lamps.

[0138] Clause 58 - A method for detecting a target tissue according to Clause 49, wherein the surgical system includes a display, and the method further includes the step of displaying a fluorescent signal on the display.

[0139] Clause 59 - A method for detecting a target tissue according to Clause 49, wherein the working instrument includes at least one electrode configured to apply a stimulating current to a target tissue, and the method for detecting a target tissue includes the steps of applying an electrical stimulus to the target tissue and determining whether the electrical stimulus to the target tissue affects the patient.

[0140] Clause 60 - A method for detecting target tissue in Clause 59, which controls the operation of a work instrument to prevent the work instrument from acting on target tissue, in accordance with the determination that electrical stimulation will affect the patient.

[0141] Clause 61 - A method for detecting the target tissue of Clause 60, which includes controlling the operation of a work instrument by changing the operating parameters of the work instrument.

[0142] Clause 62 - A method for detecting the target tissue of Clause 61, wherein the operating parameters include at least one of applied voltage, drawn current, and power consumption.

[0143] Article 63 - Method for detecting target tissue of Article 59, wherein an indicator is further defined as a first indicator, and the working instrument includes a second indicator, and the method for detecting target tissue further includes the step of activating the second indicator in response to a determination that electrical stimulation will affect the patient.

[0144] Clause 64 - A method for detecting a target tissue according to Clause 49, wherein the target tissue is further defined as a first target tissue, and the method further comprises the step of detecting the second target tissue using an optical system based on a second fluorescence emitted from the second target tissue.

[0145] Clause 65 - A method for detecting a target tissue according to Clause 64, further comprising the step of controlling the operation of a work instrument to prevent the work instrument from acting on the second target tissue in response to the detection of the second target tissue.

[0146] Clause 66 - A method for detecting the target tissue of Clause 64, wherein the second target tissue corresponds to a blood vessel.

[0147] Clause 67 - A method for detecting the target tissue of Clause 49, wherein fluorescence detection is performed in less than one second.

[0148] Clause 68 - A method for detecting and removing target tissue in an operating room under ambient light conditions using a surgical system, the surgical system comprising a first working instrument, a second working instrument, an attachment including at least one optical fiber, an indicator, an optical system, and an excitation source coupled to at least one optical fiber, the method for detecting target tissue comprising the steps of coupling the attachment to at least one of the first working instrument and the second working instrument, detecting the target tissue during a surgical procedure based on fluorescence emitted from the target tissue using the optical system, and the first working instrument A method for detecting and removing target tissue, comprising the steps of: activating an indicator on an attachment in response to the detection of target tissue while at least one of the first and second working instruments is in a sterile field; observing the indicator on an attachment while at least one of the first and second working instruments is in a sterile field; performing a first surgical procedure at the surgical site while the first working instrument is in the surgeon's first hand; and performing a second surgical procedure at the surgical site while holding the first working instrument in the first hand and the second working instrument is in the surgeon's second hand in response to the indicator.

[0149] Clause 69 - A method for detecting and removing the target tissue of Clause 68, wherein the first working instrument corresponds to a suction cannula and the first surgical procedure involves aspirating fluid from the surgical site.

[0150] Clause 70 - A method for detecting and removing target tissue according to Clause 68, wherein the second working instrument corresponds to bipolar forceps.

[0151] Clause 71 - A method for detecting and removing target tissue in an operating room under ambient light conditions or microscopic light conditions using a surgical system, the surgical system comprising a suction cannula including at least one optical fiber, an indicator, a working instrument, an optical system, and an excitation source coupled to at least one optical fiber, the method comprising: positioning the working instrument and the suction cannula within a sterile field including brain tissue illuminated by ambient light; detecting the target tissue during a surgical procedure using the optical system based on fluorescence emitted from the target tissue; activating the indicator of the suction cannula in response to the detection of target tissue while the suction cannula is in a sterile field; observing the indicator of the suction cannula while the suction cannula is in a sterile field; aspirating fluid from the surgical site using the suction cannula while the suction cannula is in the surgeon's first hand; and performing surgery on the target tissue using the working instrument in the surgeon's second hand in response to the indicator, while holding the suction cannula in the surgeon's first hand.

[0152] Clause 72 - A method for detecting target tissue in an operating room under ambient light conditions using a surgical system, the surgical system comprising a work instrument including at least one optical fiber, an indicator, an optical system coupled to the work instrument, and an excitation source coupled to at least one optical fiber, the method for detecting target tissue comprising the step of using the optical system to detect fluorescence emitted from target tissue during a surgical procedure by at least one optical fiber of the work instrument, the step of detecting fluorescence comprising irradiating the tissue with blue light from an excitation source using at least one optical fiber, collecting ambient light and fluorescence using at least one optical fiber, generating a fluorescence signal based on fluorescence emitted from the target tissue with ambient light removed, determining the presence of target tissue based on the detected fluorescence, and activating an indicator of the work instrument in response to the detection of target tissue, the method for detecting target tissue.

[0153] Clause 73 - Optical probe system for determining whether a patient's brain tissue is neoplastic. The optical probe system includes a sample element comprising an optical fiber configured to transmit fluorescence emitted by brain tissue, and an indicator configured to selectively emit visible light different from the fluorescence transmitted by the optical fiber. The optical probe system includes an excitation source configured to emit excitation light having a wavelength for inducing fluorescence in tumor tissue. The optical probe system includes an optical instrument coupled to the optical fiber, configured to convert fluorescence emitted by brain tissue and transmitted by the optical fiber into an electrical signal, and a controller coupled to the indicator and the optical instrument, configured to determine whether the brain tissue is neoplastic based on the electrical signal and to activate the indicator based on the determination that the brain tissue is neoplastic.

[0154] The foregoing description is merely illustrative and is not intended to limit the Disclosure, its applications, or use. The broad teachings of this Disclosure can be implemented in various ways. Therefore, while this Disclosure includes certain examples, the true scope of this Disclosure should not be limited in this way, as other modifications will become apparent upon consideration of the drawings, specification, and the claims below. It should be understood that one or more steps in the Method can be performed in a different order (or simultaneously) without altering the principles of this Disclosure. Furthermore, while each example is described above as having certain features, one or more of these features described in relation to any example of this Disclosure may be implemented in any feature of another example and / or combined with any feature of any other example, even if such combinations are not explicitly described. In other words, the examples described are not mutually exclusive, and the substitution of one or more examples with each other is also within the scope of this Disclosure.

[0155] Spatial and functional relationships between elements (e.g., between controllers, between circuit elements, between semiconductor layers, etc.) are described using a variety of terms, including “connected,” “engaged,” “joined,” “adjacent,” “next to,” “above,” “above,” “below,” and “located,” unless explicitly stated to be “direct.” If a relationship between a first element and a second element is described in the above disclosure, that relationship may be a direct relationship in which no other intervening elements are present between the first element and the second element, or it may be an indirect relationship in which one or more intervening elements (spatially or functionally) are present between the first element and the second element.

[0156] As used herein, the phrase “at least one of A, B, and C” should be interpreted as meaning a non-exclusive logic OR (A OR B OR C), and not as “at least one of A, at least one of B, and at least one of C.” The term subset does not necessarily require a specific subset. In other words, a first subset of a first set may have the same extent (equal) to the first set.

[0157] In diagrams, the direction of arrows, as indicated by the arrowhead, generally indicates the flow of information (such as data or instructions) that is important to the diagram. For example, if elements A and B exchange various pieces of information, and the information transmitted from element A to element B is relevant to the diagram, then the arrow may point from element A to element B. This one-way arrow does not mean that other information cannot be transmitted from element B to element A. Furthermore, with respect to information sent from element A to element B, element B can send a request for information or an acknowledgment of receipt to element A.

[0158] In this application, including the definitions below, the terms “controller” or “module” may be replaced with the term “circuit.” The term “controller” refers to, is, or includes some or all of the above, including, application-specific integrated circuits (ASICs), programmable system-on-chip (PSoCs), digital, analog, or mixed analog / digital discrete circuits, digital, analog, or mixed analog / digital integrated circuits, combinational logic circuits, field-programmable gate arrays (FPGAs), processor circuits (shared, dedicated, or grouped) that execute code, memory circuits (shared, dedicated, or grouped) that store code executed by the processor circuits, other suitable hardware components that provide the described functionality, or system-on-chips.

[0159] The controller may include one or more interface circuits with one or more transceivers. In some examples, the interface circuits may implement wired or wireless interfaces that connect to a local area network (LAN) or a wireless personal area network (WPAN). Examples of LANs include IEEE standard 802.11-2016 (also known as the Wi-Fi wireless networking standard) and IEEE standard 802.3-2015 (also known as the Ethernet wired networking standard). An example of a WPAN is Bluetooth. (Registered trademark) There are Bluetooth wireless networking standards from the Special Interest Group and the IEEE standard 802.15.4.

[0160] A controller can communicate with other controllers using interface circuits. While this disclosure describes controllers communicating logically and directly with each other, in various implementations, controllers can actually communicate via a communication system. This communication system may include physical and / or virtual networking equipment such as hubs, switches, routers, gateways, and transceivers. In some implementations, the communication system connects to or traverses a wide area network (WAN), such as the Internet. For example, the communication system may include multiple LANs interconnected via the Internet or point-to-point dedicated lines using technologies such as Multiprotocol Label Switching (MPLS) or Virtual Private Networks (VPNs).

[0161] In various implementations, controller functionality can be distributed among multiple controllers connected via a communication system. For example, multiple controllers may implement the same functionality distributed by a load balancing system. In a further example, controller functionality can be split between a server (also known as a remote or cloud) controller and a client (or user) controller.

[0162] Some or all of the controller's hardware features conform to IEEE standard 1364-2005 (commonly known as "Verilog"). (Registered trademark) Hardware description languages ​​can be defined using hardware description languages ​​such as IEEE standard 1076-2008 (commonly known as "VHDL"). Hardware description languages ​​can be used to manufacture and / or program hardware circuits. In some implementations, some or all of the controller's functions may be defined by a language such as IEEE 1666-2005 (commonly known as "SystemC"), which encompasses both the code and hardware description described below.

[0163] The term "code" as used above includes software, firmware, and / or microcode, and may refer to programs, routines, functions, classes, data structures, and / or objects. The term "shared processor circuit" includes a single processor circuit that executes some or all of the code from multiple controllers. The term "group processor circuit" includes 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 in a single processor circuit, multiple threads in a single processor circuit, or a combination of the above. The term "shared memory circuit" includes a single memory circuit that stores some or all of the code from multiple controllers. The term "group memory circuit" includes a memory circuit that, in combination with additional memory, stores some or all of the code from one or more controllers.

[0164] The term "memory circuit" is a subset of the term "computer-readable medium." As used herein, the term "computer-readable medium" does not encompass transient electrical or electromagnetic signals propagating through a medium (such as a carrier wave). Therefore, the term "computer-readable medium" may be considered tangible and non-transient. Non-exclusive examples of non-transient computer-readable mediums include non-volatile memory circuits (such as flash memory circuits, erasable programmable read-only memory circuits, or mask read-only memory circuits), volatile memory circuits (e.g., static random-access memory circuits or dynamic random-access memory circuits), magnetic storage media (such as analog or digital magnetic tapes, hard disk drives, etc.), and optical storage media (such as CDs, DVDs, or Blu-ray discs).

[0165] The apparatus and methods described in this application may be partially or fully implemented by a dedicated computer created by configuring a general-purpose computer to perform one or more specific functions incorporated into a computer program. The aforementioned functional blocks and flowchart elements may serve as software specifications that can be translated into a computer program through the routine work of a skilled technician or programmer.

[0166] A computer program includes processor-executable instructions stored in at least one non-temporary computer-readable medium. A computer program may also include, or depend on, stored data. A computer program may include a basic input / output system (BIOS) that interacts with the hardware of a dedicated computer, device drivers that interact with specific devices of the dedicated computer, one or more operating systems, user applications, background services, and background applications.

[0167] A computer program may include (i) descriptive text to be parsed, such as HTML (Hypertext Markup Language), XML (Extended 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; and (v) source code compiled and executed by a just-in-time compiler. For example, source code can be in C, C++, C#, Objective-C, or Swift. (Registered trademark)It can be written using syntax from languages ​​including Haskell, Go, SQL, R, Lisp, Java®, Fortran, Perl, Pascal, Curl, OCaml, JavaScript®, HTML5 (Hypertext Markup Language 5th 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 suction device configured to apply suction force to brain tissue, comprising a handle including a control portion having a distal end, A sample element comprising at least one optical fiber configured to be coupled to the suction device and to collect fluorescence emitted from brain tissue, An indicator configured to be coupled to the suction device and selectively emit light, the indicator being located near the distal end of the optical fiber, but closer to the distal end of the control portion of the handle than to the distal end of the optical fiber, A controller configured to detect the type of brain tissue based on the fluorescence and to activate the indicator according to the detected type of brain tissue, A surgical suction system equipped with [specific features / equipment].

2. The surgical aspiration system according to claim 1, wherein the at least one optical fiber is coupled to an excitation source, and the at least one fiber is configured to irradiate excitation light from the excitation source in order to induce fluorescence emitted from brain tissue and collect the fluorescence.

3. The surgical aspiration system according to claim 2, further comprising the controller and an optical system coupled to the sample element, wherein the optical system includes the excitation source and an optical detection system configured to convert the fluorescence into an electrical signal, and the controller detects the type of brain tissue from the electrical signal.

4. A suction device configured to apply suction force to brain tissue, An optical system, A first excitation source configured to emit a first excitation light, A second excitation source configured to emit a second excitation light, and An optical detection system configured to convert a first fluorescence into a first electrical signal and a second fluorescence into a second electrical signal. Optical systems including, A sample element comprising at least one optical fiber coupled to the suction device and coupled to the first excitation source and the second excitation source, wherein the at least one optical fiber is configured to emit a first excitation light from the first excitation source to induce a first fluorescence, emit a second excitation light from the second excitation source to induce a second fluorescence, and collect one of the first fluorescence and the second fluorescence emitted from the brain tissue, An indicator configured to be coupled to the suction device and selectively emit light, It is a controller, To detect the first type of brain tissue based on the first electrical signal, To detect the second type of brain tissue based on the second electrical signal, and Activating the indicator based on the type of brain tissue detected, A controller configured to perform the following actions: Equipped with a surgical suction system.

5. The surgical aspiration system according to claim 3, wherein the controller is configured to detect the type of brain tissue based on an algorithm.

6. The surgical aspiration system according to claim 5, wherein the algorithm includes a calibration routine to be performed with respect to healthy tissue or baseline parameters.

7. The surgical aspiration system according to claim 5, wherein the algorithm is configured to calculate a modified electrical signal by fitting a baseline polynomial curve to the electrical signal, and to subtract the baseline polynomial curve from the electrical signal to remove ambient light.

8. The surgical aspiration system according to claim 7, wherein the algorithm includes fitting at least one Gaussian distribution to the modified electrical signal.

9. The surgical aspiration system according to claim 5, wherein the controller is configured to periodically switch the excitation source on and off, the sample element is configured to collect ambient light when the excitation source is off and not illuminating brain tissue with fluorescence, the sample element is configured to collect ambient light and the fluorescence when the excitation source is on and the sample element is illuminating brain tissue with fluorescence, and the algorithm includes subtracting the ambient light from the fluorescence.

10. A suction device configured to apply suction force to brain tissue, A sample element comprising at least one optical fiber configured to be coupled to the suction device and to collect fluorescence emitted from the brain tissue, An indicator configured to be coupled to the suction device and selectively emit light, Electrodes configured to apply electrical stimulation to brain tissue, It is a controller, To detect the type of brain tissue based on the fluorescence, Activating the indicator according to the type of brain tissue detected, and The system generates an alarm when the electrical stimulation elicits a predetermined response from the patient. A controller configured to perform the following actions: Equipped with a surgical suction system.

11. The surgical suction system according to claim 1, wherein the suction device further includes an elongated portion, and the sample element is coupled to the elongated portion.

12. The surgical suction system according to claim 2, wherein the indicator is an indicator fiber.

13. The surgical aspiration system according to claim 12, wherein the indicator fiber is coupled to a second light source, and the second light source generates light of a different wavelength from the excitation light.

14. The surgical aspiration system according to claim 6, wherein the controller is configured to generate an operating signal based on a comparison between the PPIX intensity in a PPIX emission band adapted to the Gaussian band and a predetermined intensity threshold.

15. A neurosurgical system for examining a patient's brain tissue with respect to tumor tissue, A suction device configured to apply suction force to a patient's tissue, A suction cannula to define the lumen, A handle, including a control portion having a distal end configured to receive the proximal end of the suction cannula, An optical fiber coupled to the aforementioned suction cannula, configured to transmit fluorescence emitted by brain tissue, and comprising an optical fiber, An indicator coupled to the suction cannula, located near the distal end of the optical fiber, but proximal to the distal end of the optical fiber relative to the distal end of the control portion of the handle, and configured to selectively emit visible light different from the fluorescence transmitted by the optical fiber, A suction device equipped with, An excitation source configured to emit excitation light, wherein the excitation light has a wavelength that induces fluorescence in tumor tissue, An optical device coupled to the optical fiber, configured to convert fluorescence emitted by brain tissue and transmitted through the optical fiber into an electrical signal, A controller coupled to the optical device, Based on the aforementioned electrical signals, it is determined that the brain tissue is neoplastic, and Activating the indicator based on the aforementioned determination that the brain tissue is neoplastic, A controller configured to perform the following actions: A neurosurgical system equipped with [the necessary components].

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