Neurosurgical methods and systems for detecting and removing tumor tissue - Patents.com

Abstract

A neurosurgical system for examining a patient's brain tissue for tumor tissue includes a suction instrument, an excitation source, an optical instrument, and a controller. The suction instrument includes a suction 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 patent application claims priority to and the entire benefit of U.S. Provisional Patent Application No. 63 / 406,966, filed September 15, 2022, the contents of which are incorporated herein by reference in their entirety. [Background technology]

[0002] Glioma tumors can arise in the glial cells of the brain or spine. Surgery, more specifically tumor resection, is often performed to remove the tumor. The goal of tumor resection surgery is to achieve a gross total resection (GTR). A highly aggressive form of glioma is glioblastoma. In patients with glioblastoma, GTR has been shown to extend the patient's lifespan by approximately 40% (e.g., 10 to 14 months). In patients with low-grade glioma, GTR increases the overall chances of survival.

[0003] 5-aminolevulinic acid (5-ALA) is often administered to patients several hours before surgery. 5-ALA is a naturally occurring compound in the hemoglobin synthesis pathway. In cancer cells, hemoglobin synthesis is interrupted, terminating the pathway at an intermediate compound called protoporphyrin IX (PPIX). During surgery, medical professionals may illuminate an area of ​​brain tissue with excitation light (i.e., blue light) from a surgical microscope. 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 with specific optical properties (red fluorescence). The fluorescence may be observed by medical professionals through a surgical microscope.

[0004] Once the target tissue is identified, the medical professional switches the surgical microscope back to standard white light illumination and continues resecting the target tissue. The medical professional alternates between illuminating the tissue with white light and the excitation light throughout the surgical procedure to ensure that the appropriate target tissue is resected until tumor resection is complete. Each time the target area is illuminated with excitation light from the surgical microscope, PPIX present at the tumor site may be degraded due to photobleaching caused by exposure to the intense excitation light.

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

[0006] The background information provided herein is intended to generally describe the contents of the present disclosure. To the extent described in this Background section, the work of the currently named inventors, and aspects of the description that may not have been admitted as prior art at the time of filing, are not admitted, expressly or impliedly, as prior art to the present disclosure. Summary of the Invention

[0007] One general aspect of the present disclosure includes a neurosurgical system for distinguishing healthy brain tissue from tumorous brain tissue. The neurosurgical system also includes a handheld optical probe configured to be positioned adjacent to tissue of interest, a spectrometer configured to receive light collected from the handheld optical probe and output a corresponding spectrometer signal, a controller in communication with the spectrometer, and an indicator in communication with the controller. The controller is configured to: obtain a first digital signal based on the spectrometer signal; calculate a second signal by removing the effects of ambient light from the spectrometer signal; fit multiple bands to the second signal; select a fitting band from the multiple fitted bands based on an average value criterion; determine an intensity of the selected fitting band; and control the indicator based on the intensity of the selected fitting band. Other implementations of this aspect include corresponding computer systems, apparatuses, and computer programs stored on one or more computer storage devices, each configured to perform the operations of the method.

[0008] Another general aspect includes a neurosurgical instrument assembly for distinguishing brain tumor tissue from healthy brain tissue. The neurosurgical instrument assembly also includes: a tubular member defining a lumen and having an exterior surface; a single optical fiber coupled to the tubular member, the single optical fiber adapted to transmit excitation light to and receive light emitted from the target brain tissue; an indicator light coupled to the tubular member and configured to emit light in a visible wavelength; a connector line extending from the neurosurgical instrument; and a connector coupled to the connector line, the connector including a single optical fiber coupling and an electrical terminal, and configured to connect to a surgical console including a light source and a controller. Other implementations of this aspect include corresponding computer systems, apparatus, and computer programs recorded on one or more computer storage devices, each configured to perform the operations of the method.

[0009] Another general aspect includes a neurosurgical system for distinguishing brain tumor tissue from healthy brain tissue. The neurosurgical system also includes a handheld optical probe configured to be positioned adjacent to the tissue of interest, a spectrometer configured to receive collected light from the handheld optical probe and output a corresponding spectrometer signal, and a controller in communication with the spectrometer, the controller configured to calculate a second signal by removing the effects of ambient light from the spectrometer signal, identify a single band associated with PPIX based on the second signal, and control an indicator based on the intensity of the single band. Other implementations of this aspect include corresponding computer systems, apparatus, and computer programs recorded on one or more computer storage devices, each configured to perform the operations of the method.

[0010] Any of the above aspects can be combined in whole or in part. Any features of the above aspects can be combined in whole or in part. Any of the above implementations of any aspect can be combined with any other aspect. Any of the above implementations can be combined with any other implementation of the same or a different aspect.

[0011] The advantages of the present disclosure may be readily appreciated as the same becomes better understood by reference to the following detailed description when considered in conjunction with the accompanying drawings, in which: [Brief explanation of the drawings]

[0012] [Figure 1] 1 shows a chart illustrating the visibility of red fluorescence in tumor tissue when viewed through a surgical microscope according to the teachings of the prior art. [Figure 2] 1 illustrates a neurosurgical system according to the teachings of the present disclosure. [Figure 3] 1 shows a functional block diagram of a neurosurgical system according to the teachings of the present disclosure. [Figure 4] 1 illustrates an example of a suction instrument of a neurosurgical system according to the teachings of the present disclosure. [Figure 5A]1 illustrates an example of a handle for a suction instrument of a neurosurgical system according to the teachings of the present disclosure. [Figure 5B] 1 illustrates an example of a handle for a suction instrument of a neurosurgical system according to the teachings of the present disclosure. [Figure 6] 1 illustrates an ultrasonic surgical system of a neurosurgical system in accordance with the teachings of the present disclosure. [Figure 7] 1 illustrates a tissue detection system of a neurosurgical system according to the teachings of the present disclosure. [Figure 8] FIG. 1 shows a functional block diagram of a tissue detection system of a neurosurgical system according to the teachings of the present disclosure. [Figure 9A] 1 illustrates an optical system of a tissue detection system according to the teachings of the present disclosure. [Figure 9B] 1 illustrates an optical system of a tissue detection system according to the teachings of the present disclosure. [Figure 10A] 1 illustrates an exploded view of some components of an optical system of a tissue detection system according to the teachings of the present disclosure. [Figure 10B] 1 illustrates an exploded view of some components of an optical system of a tissue detection system according to the teachings of the present disclosure. [Figure 11] 1 illustrates an internal view of a control console of a tissue detection system according to the teachings of the present disclosure. [Figure 12A] 1 illustrates sample elements of a tissue detection system according to the teachings of the present disclosure. [Figure 12B] 1 illustrates sample elements of a tissue detection system according to the teachings of the present disclosure. [Figure 12C] 1 illustrates sample elements of a tissue detection system according to the teachings of the present disclosure. [Figure 12D] 1 illustrates sample elements of a tissue detection system according to the teachings of the present disclosure. [Figure 12E] 1 illustrates sample elements of a tissue detection system according to the teachings of the present disclosure. [Figure 13] 1 illustrates an excitation spectrum signal produced by a spectrometer of a tissue detection system according to the teachings of the present disclosure. [Figure 14A] 1 illustrates a first modified spectral signal generated by a controller of a tissue detection system in accordance with the teachings of the present disclosure. [Figure 14B] 10 illustrates a second modified spectral signal generated by a controller of a tissue detection system in accordance with the teachings of the present disclosure. [Figure 15] 10 illustrates a Gaussian curve fitting to a second modified signal generated by a controller of a tissue detection system in accordance with the teachings of the present disclosure. [Figure 16] 1 illustrates protoporphyrin IX (PPIX) intensity generated by a controller of a tissue detection system according to the teachings of the present disclosure. [Figure 17] 1 shows a flowchart of a surgical resection procedure performed using a neurosurgical system according to the teachings of the present disclosure. [Figure 18A] 1 illustrates a sample element of a tissue detection system coupled to an ultrasonic handpiece assembly in accordance with the teachings of the present disclosure. [Figure 18B] 1 illustrates a sample element of a tissue detection system coupled to an ultrasonic handpiece assembly in accordance with the teachings of the present disclosure. [Figure 19A] 1 illustrates a tissue detection sample element and indicator element coupled to a bipolar forceps of a surgical system according to the teachings of the present disclosure. [Figure 19B] 1 illustrates a tissue detection sample element and indicator element coupled to a bipolar forceps of a surgical system according to the teachings of the present disclosure. [Figure 20] 1 illustrates a sample element coupled to a suction fixture of a suction system with the jacket removed in accordance with the teachings of the present disclosure. [Figure 21] 1 illustrates a sample element coupled to an aspiration apparatus of an aspiration system according to the teachings of the present disclosure. [Figure 22] 1 illustrates a sample element coupled to an aspiration apparatus of an aspiration system according to the teachings of the present disclosure. [Figure 23] 1 illustrates a sample element coupled to an aspiration apparatus of an aspiration system according to the teachings of the present disclosure. [Figure 24] 1 illustrates one implementation of a sample element coupled to a suction apparatus including a jacket according to the teachings of the present disclosure. [Figure 25]25 shows a side perspective view of a portion of the suction apparatus of FIG. 24, shown with the jacket removed for illustrative purposes. [Figure 26A] 25 shows a perspective view of a portion of the suction apparatus of FIG. 24, with the handle of the suction apparatus shown including an opening. [Figure 26B] 25 shows a perspective view of a portion of the suction apparatus of FIG. 24, with the handle of the suction apparatus shown including an opening. [Figure 27] 24-26C show bottom perspective views of a portion of the distal end of the suction apparatus of FIGS. 24-26B, where the suction apparatus is shown defining an outer channel that extends to the distal end of the suction apparatus. FIG. [Figure 28] 1 illustrates an optical block according to the teachings of the present disclosure. [Figure 29] 29 illustrates the optical block of FIG. 28, shown coupled to a connector in accordance with the teachings of the present disclosure. [Figure 30] 1 illustrates a bottom perspective view of a portion of an optical block, the optical block shown including an adjustment mechanism in accordance with the teachings of the present disclosure. [Figure 31] FIG. 1 shows an exemplary block diagram for distinguishing brain tumor tissue from healthy brain tissue according to the teachings of the present disclosure. [Figure 32] 10 illustrates another implementation of a sample element coupled to a suction instrument including a sleeve according to the teachings of the present disclosure. [Figure 33] 33 shows a perspective view of a portion of the suction apparatus of FIG. 32, with the handle of the suction apparatus shown including an opening. [Figure 34] 34 shows a side view of a portion of the handle of the suction instrument of FIG. 33. [Figure 35] 35 shows a cross-sectional perspective view of a portion of the distal end of the suction apparatus of FIGS. 32-34, where the suction apparatus is shown defining an outer channel that extends to the distal end of the suction apparatus. FIG. [Figure 36] 35 shows an enlarged perspective view of a portion of the distal end of the suction instrument of FIGS. 32-34, with the distal sleeve shown removed from the distal end. FIG. [Figure 37] 37 shows a perspective view of the distal end of the suction instrument of FIG. 36, with the distal and proximal sleeves shown removed from the distal end. [Figure 38] 36 shows another cross-sectional perspective view of a portion of the suction apparatus of FIG. 35, showing the handle of the suction apparatus. [Figure 39] FIG. 33 is a cross-sectional side view of the suction apparatus and handle of FIG. 32. [Figure 40] FIG. 33 is a cross-sectional top view of the handle of the suction instrument of FIG. 32. [Figure 41] FIG. 35 is a cross-sectional view of the distal end of the suction instrument of FIGS. 32-34, showing the distal sleeve removed from the distal end; [Figure 42] 33 is a schematic side view of the manufacturing process for the suction instrument of FIG. 32, showing the suction tube, optical fiber, and proximal jacket in an unrecovered state. [Figure 43] 33 is a schematic end view of the manufacturing process for the suction instrument of FIG. 32, showing the suction tube, optical fiber, and proximal jacket in a partially restored state. [Figure 44] FIG. 44 is an exemplary block diagram of the manufacturing process of FIGS. 42 and 43. [Figure 45] 33 is a side view of the optical connector of the suction instrument of FIG. 32 with a portion of the casing removed. 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 a 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 the need for a darkened or dimly lit operating room) during the tumor resection process. There is also a need for a system that can shorten the time the target area is illuminated with excitation light to reduce photobleaching effects. Furthermore, there is a need for a system that can deliver excitation light into deep cavities, as surgical microscopes cannot adequately deliver excitation light into deep cavities. Finally, there is a need for a system that assists in the intraoperative detection of undifferentiated foci of tumors, as their detection is essential for accurate histopathological diagnosis and optimal patient treatment.

[0015] While this disclosure specifically discusses surgical procedures related to the resection of targeted brain tumor tissues by administering 5-ALA to visualize the fluorescence of protoporphyrin IX (PPIX), the teachings of this disclosure can also be extended to other types of surgical procedures to detect other types of tissues and other types of fluorescent dyes (e.g., hypericin, Hexvix, idocyanine green (ICG)). For example, ICG may be administered to help medical professionals visualize blood vessels during surgical procedures. ICG may bind to plasma proteins present in 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 the ICG.

[0016] With reference to FIG. 1 , chart 10 illustrates the visibility of red fluorescence of PPIX when viewed through a surgical microscope. During brain tumor resection surgery, if the tumor resection surgery is performed according to prior art systems (i.e., using a surgical microscope), target tissue (i.e., tumor tissue) containing high concentrations of PPIX may be inadvertently missed, resulting in a suboptimal GTR. Therefore, a method for more accurately detecting elevated concentrations of PPIX would prove highly beneficial in aiding in the achievement of GTR. Open boxes 40 indicate specimens that do not produce visible fluorescence, while solid boxes 44 indicate specimens that do produce visible fluorescence. The y-axis indicates the accumulation level of PPIX concentration (CPpIX) above a threshold of 0.1 μg / mL. The x-axis indicates visible (+F) and non-visible (-F) fluorescence for healthy tissue and for target tissue. Region 50 represents a false-negative region where PPIX was present in the specimen but did not produce visible light. Notably, subregion 54 within region 50 contains specimens below level 58 when viewed through a surgical microscope, but still contains CpIX. PpIX It is believed that the subregion contains elevated levels of PPIX. Therefore, if the medical professional misses the PPIX corresponding to the subregion, GTR will not be achieved.

[0017] Referring to FIG. 2 , a neurosurgical system 100 is provided that addresses 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 an aspiration system 113. The surgical navigation system 104 includes a cart assembly 106 that houses a navigation computer 110. The navigation computer 110 is also referred to as a navigation controller. A navigation interface is in operative communication with the navigation computer 110. The navigation interface may include one or more input devices, which may be used to input information into the navigation computer 110 or to select / control certain aspects of the navigation computer 110. The navigation interface includes one or more displays 120. Such input devices may include an interactive touchscreen display / menu, a keyboard, a mouse, a microphone (voice activation), a gesture control device, etc.

[0018] The navigation computer 110 may be configured to store one or more preoperative or intraoperative images of the brain. Any suitable imaging device may be used to provide preoperative or intraoperative images of the brain, such as 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), or optical coherence tomography (OCT). Images may also be acquired and displayed in 2D, 3D, or 4D. In more advanced forms, 4D surface renderings of the body may be achieved by incorporating patient or other data from atlases or anatomical model maps, or from preoperative image data captured by MRI, CT, or echocardiography.

[0019] Navigation computer 110 can generate one or more images of the brain on display 120. Navigation computer 110 can also be connected to surgical microscope 108. For example, display 120 can display an image corresponding to the field of view of surgical microscope 108. If navigation computer 110 can include two or more displays, one such display can show the field of view of surgical microscope 108, and another such display can show a pre-operative or intra-operative image of the brain.

[0020] The tracking system 124 is coupled to the navigation computer 110 and configured to sense the position of one or more tracking elements attached to the surgical instrument or the patient. The tracking system 124 may be configured to track active or passive infrared tracking elements attached to the surgical instrument or the patient. One 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 various functions and features such as those described in U.S. Pat. Nos. 7,725,162 (B2) and 11,369,438 (B2), which are incorporated herein by reference in their entireties.

[0021] The surgical microscope 108 includes one or more objective lenses configured to provide a range of magnifications (e.g., from about 2x to about 50x). The surgical microscope 108 can have a field of view with a predetermined range of areas. 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 infrared light spectrum) to irradiate the 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 fluorescent wavelengths 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 is coupled to the surgical cart and may be operably connected to the surgical system 112, the tissue detection system 116, and / or the ultrasonic surgical system 118 for displaying information associated with each respective system 112, 116, 118. A medical professional may use the ultrasonic surgical system 118 and / or the surgical system 112 to ablate targeted tissue in a patient's brain. The ultrasonic surgical system 118 may include an ultrasound control console 128 and an ultrasonic handpiece assembly 130.

[0023] The suction system 113 may include a suction apparatus 156 and a suction unit 117 for controlling various aspects of the suction apparatus 156. A suction tube may connect the suction apparatus 156 to the suction system 113. The suction system 113 may receive suction from a vacuum source, such as a vacuum outlet at a medical facility. The suction system 113 may include one or more regulators or one or more adjustment 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 apparatus 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 apparatus 156 may have various features, as described in U.S. Pat. No. 9,066,658 B2 and U.S. Patent Application Publication No. 2018 / 0344993 A1, the entireties of which are incorporated herein by reference. The systems and devices discussed in International Application No. 2022190076 are incorporated herein by reference. The systems and devices discussed in International Application No. 2021123912 are incorporated herein by reference.

[0024] The surgical system 112 may include a surgical instrument, such as a bipolar forceps 160, and a surgical control console 115 for controlling various aspects of the surgical instrument. A medical professional may also use the surgical instrument to perform a surgical operation on tissue, for example, to resect or cauterize tissue. The bipolar forceps may have features such as those described in U.S. Pat. No. 8,361,070 (B2), which is incorporated herein by reference in its entirety. While this disclosure discusses and illustrates that the surgical instrument may include a bipolar forceps 160, the surgical system 112 and surgical instrument may include other instruments, such as a nerve stimulator, a dissector, or an ablation device (e.g., an RF ablation device and / or a laser ablation device). For example, the surgical system and / or surgical instrument may have various features such as those described in U.S. Pat. No. 8,267,934 (B2), which is incorporated herein by reference in its entirety. A medical professional may use any number of surgical systems and any number of surgical instruments when performing a surgical procedure.

[0025] The tissue detection system 116 may include a control console 168 and a sample element 164 (shown coupled to the ultrasonic handpiece assembly 130). The control console 168 can provide real-time indication to the medical professional via the sample element 164 when the brain tissue 111 corresponds to the target tissue. The sample element 164 may also be coupled to a bipolar forceps 160, a suction instrument 156, or other surgical instrument, as described in more detail below. The tissue detection system 116 determines when the brain tissue 111 corresponds to the target tissue based on fluorescence emitted by the target tissue 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. As described in more detail below, the tissue detection system 116 can determine that the target tissue is present based on the intensity and wavelength of the fluorescence emitted by PPIX.

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

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

[0028] As the medical professional is ablating the target tissue, the control console 168 can function to provide the medical professional with a real-time display of the target tissue within the brain tissue 111 by activating an indicator (described in more detail below) on the sample element 164. The tissue detection system 116 according to the teachings of the present disclosure prevents the medical professional from having to switch back and forth between different lighting settings on the surgical microscope 108 (i.e., illuminating the tissue with excitation light and white light) as the medical professional is ablating the target tissue. This becomes 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 FIG. 4, the suction instrument includes a suction cannula 157 and a handle 159. The suction cannula 157 defines a lumen for aspirating fluid, debris, and tissue from a patient. The handle 159 is tubular with a control portion 167, which may be square. The distal end 162 may be tapered and is configured to receive the proximal end 161 of the suction cannula 157. The proximal end 165 of the handle 159 includes a vacuum fitting, which may be configured to receive a suction tube 169 that is connected to a vacuum source that generates suction pressure. The vacuum fitting may be a standard barbed fitting, a quick disconnect, or any other suitable fitting known in the art that allows the suction tube to be fluidly coupled to a vacuum source.

[0030] 5A and 5B, the control portion 167 can include a teardrop-shaped control 170 for adjusting the suction pressure. For example, when no portion of the teardrop-shaped control 170 is covered by the medical professional, the suction pressure can be minimum, and when the teardrop-shaped control 170 is completely covered, the suction pressure can be maximum. Although the control portion 167 is described as including a teardrop-shaped control, the control portion 167 can include another suitable input, such as a button or a differently shaped control, to allow the medical professional to vary the suction pressure. The control portion includes a through-hole 171 for receiving the sample element 164, as described in more detail below. The medical professional holds the suction instrument 156 from the handle 159 and manipulates the suction instrument 156 so that the distal end 163 contacts the patient's tissue during the surgical procedure to provide suction at the desired location. While the suction instrument 156 is described as having a Fukushima configuration, other configurations, such as a Frazier configuration or a Poole configuration, are also contemplated.

[0031] Referring to FIG. 6 , the ultrasonic handpiece assembly 130 may include an ultrasonic handpiece 132 having a proximal end and a distal end. The ultrasonic handpiece assembly 130 may further include a sleeve 136 and an ultrasonic tip 140 that may be coupled to the distal end of the ultrasonic handpiece 132. The sleeve 136 may be configured to provide irrigation to the ultrasonic tip 140 and / or the surgical site. It is further contemplated that the sleeve 136 may be configured to provide suction to the ultrasonic tip 140. The ultrasonic tip 140 may include a cutting mechanism configured to ablate, cut, shape, and / or remove biological tissue. The ultrasonic handpiece assembly 130 may have various features as described in U.S. Pat. Nos. 6,497,715 B2, 6,955,680 B2, and 6,984,220 B2, which are incorporated herein by reference in their entireties, as well as International Application Publication No. WO 2020 / 068756 A1.

[0032] The ultrasonic handpiece assembly 130 may also include a cable 144 or other power cord with a power connector 148 or adapter configured to couple 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 provide irrigation and / or aspiration via one or more tubes (not shown) connected to the handpiece assembly 130 to adjust the irrigation and / or aspiration functions of the ultrasonic handpiece assembly 130 and optimize ultrasonic handpiece assembly 130 performance. One 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 may control various operating parameters based on signals received from the tissue detection system 116.

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

[0034] The user interface 208 may include a display for displaying 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 engagement by a medical professional. A power supply 212 may provide power to the 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 a communication link 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 described in further detail below.

[0035] The mapping module 265 may include a device configured to generate stimulation signals for electrodes 266 configured to deliver the stimulation signals 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 regions of the brain tissue 111 correspond to functionally important regions. For example, functionally important brain regions responsible for language or motor skills may be selected to be avoided if the target tissue cannot be removed without affecting the underlying function of the region, even if it is determined that these regions contain the target tissue. The device may be configured to generate an electric current, which is then applied by the medical professional to the brain tissue 111 via the electrodes. The electrodes may be stand-alone electrodes disposed on or coupled to the exterior surface of the sample element 164, or the electrodes may be incorporated within the sample element 164, as described in more detail below. The mapping module 265 and / or the electrodes 266 may have various functions and features as described in U.S. Patent Application Publication No. 2022 / 0400972 A1 and U.S. Patent No. 7,150,737 B2, the entireties of which are incorporated herein by reference. The controller 204 may be configured to generate an alert based on the results of stimulation of the electrodes 266 on the brain tissue 111. For example, the controller 204 may generate an alert to be displayed on the user interface 208, the display 120, or the display 121. The alert may indicate to a medical professional whether the brain tissue 111 corresponds to a functionally important region, such as a region associated with 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 can 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 can also be configured to emit excitation light corresponding to other wavelengths, such as wavelengths associated with the remainder of the visible light spectrum (e.g., greater than 500 nm but less than 700 nm), wavelengths associated with the ultraviolet light spectrum (less than 400 nm), and / or wavelengths associated with the infrared light spectrum (greater than 700 nm). The excitation source 228 can include any number of light sources, such as light-emitting diodes (LEDs), pulsed lasers, continuous wave lasers, modulated lasers, filtered white light sources, etc. In implementations in which the excitation source is an LED, the device can be used without hazard to the eyes of individuals in the operating room.

[0037] In certain instances, the excitation source may be further configured to emit excitation light corresponding to a different wavelength than the aforementioned. In this implementation, 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 a 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 modifying operating parameters of the excitation source 228. The operating parameters can correspond to time settings, power settings, or other suitable settings. The time settings can include a pulse width. The pulse width can be based on an integration time of the spectrometer 224. The integration time of the spectrometer 224 is described in more detail below.

[0039] The detection fiber 264 may be coupled to the optical connector 229. When the sample element 164 is coupled to a surgical instrument (i.e., the ultrasonic handpiece assembly 130, the suction instrument 156, or the 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] 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 made of metal or other suitable material and completely enclose the components 232 of the optical block 216. FIG. 9B 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] 10A and 10B , exploded views of components 232 of 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. First portion 280 may include an optical path 285 for excitation light to travel from one or more excitation sources 228 to brain tissue 111 via detection fibers 264. Optical path 285 may be defined by components 232 within first portion 280 of the optical block. Second portion 284 may include an optical path 287 for collected light to travel from brain tissue 111 to spectrometer 224 via detection fibers 264. Optical path 287 may be defined by components 232 within second portion 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 other optical components, such as one or more mirrors, lenses, optical connectors, optical fibers, and / or any other suitable optical components.

[0042] 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 the 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., a filter may be omitted) to the target tissue via the detection fiber 264. The detection fiber 264 may direct 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. Coupling of the sample element 164 to a surgical instrument brings the distal end 272 adjacent to the working portion of the surgical instrument to allow light to 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 the surgical microscope 108, surgical lamps, or other devices in the operating room, the light collected from the brain tissue 111 may include ambient and / or background light. The light collected by the detection fiber 264 passes through a component 232, such as a long-pass filter, in the second portion 284 of the optical block 216. After the light passes through component 232, the light may enter a spectrometer 224 that is coupled to the optical block 216.

[0045] Because lighting conditions may vary, light collection from the brain tissue 111 may be collected at faster clock cycles, i.e., greater than 50 kHz, to maintain a high signal-to-noise ratio in the spectrometer. For example, in some configurations, light collection is performed at a rate of 1.8 MHz. In this manner, light collection time can be reduced, and processing time can be shortened, reducing the effects of any type of noise and avoiding saturation of the collected light, regardless of lighting conditions.

[0046] The detection fiber 264 may be coupled to an optical connector 229. As described in more detail below, the distal end 272 of the detection fiber 264 may include a lens or other transparent material such that when the sample element 164 is positioned on a surgical instrument (i.e., an ultrasonic handpiece, a suction instrument, or bipolar forceps), the distal end 272 of the detection fiber 264 is adjacent to a working portion of the surgical instrument so as to couple the sample element 164 to the surgical instrument thereby enabling excitation light to be delivered to the target tissue.

[0047] 11 , a view of the control console 168 is shown with the outer casing removed. The optical block 216 may be secured directly to the base 217 of the control console 168 (e.g., via bolts) to allow for heat dissipation for heat generated by one or more components of the optical system 215. The control console 168 may include sufficient clearance to allow multiple optical blocks 216 to be stacked within the control console 168. For example, a second optical block with various optical components therein 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 an optical path for light generated by the second excitation source to reach the target tissue.

[0048] Referring to FIG. 12A , the sample element 164 is shown. The sample element 164 may also include an indicator element 296. The indicator element 296 may be attached to the sample element 164 or any surgical instrument, including an optical probe. 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 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 terminate well before the distal end 272 of the detection fiber 264, leaving the transmission element 297, the indicator 298, and the detection fiber 264 at least partially exposed. Jacket 292 may be formed from any one of polyvinyl chloride, polyethylene, chlorinated polyethylene, and chlorosulfonated polyethylene / neoprene, or another suitable material. Electrode 266, although not shown in FIG. 12A , may be integral with sample element 164. For example, the distal end of the electrode may be positioned adjacent to the distal end of detection fiber 264 such that the distal end of electrode 266 can contact brain tissue 111.

[0049] As previously mentioned, the detection fiber 264 can carry excitation light from the optical system 215 to the brain tissue 111, and the detection fiber 264 can collect light from the brain tissue 111 and deliver it to the optical system 215, which provides a filtered optical signal to the spectrometer 224. In such a configuration, the use of a single fiber offers several advantages: the emitted light and the detected light must pass through exactly the same location, allowing for more accurate localization of the tumor.

[0050] The detection fiber may have a diameter of 500, 450, or less than 400 microns. Using this diameter, the device requires the user to place the probe in contact with the tissue of interest. Requiring the user to place the probe in contact with the tissue can more accurately identify the location of the tumor. If a larger diameter fiber is used, the user can detect the fluorescence from a distance, but scattering of light by the tissue can make it more difficult for the user to determine the exact location of the tumor.

[0051] The sample element 164 may be coupled to any surgical instrument (i.e., the ultrasonic handpiece assembly 130, the suction instrument 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, a collimator, or another suitable optical component that enables the detection fiber 264 to deliver excitation light to the brain tissue 111 and to collect light from the brain tissue 111.

[0052] In this example, the detection fiber 264 functions to deliver excitation light to the tissue and collect light from the tissue, although 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 considered to be single fibers for simplicity, but it is understood that each of the fibers may include 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.

[0053] Referring to Figure 12B, there is shown a second alternative configuration of sample element 164. 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 will be omitted. The illustrated indicator 298' is cylindrical, as opposed to the spherical indicator 298 shown in Figure 12A.

[0054] Referring to FIG. 12D, a third configuration of the sample element 164 is shown. The illustrated sample element 164″ is functionally equivalent to the sample elements 164 and 164′ shown in FIGS. 12A and 12B, and therefore, a detailed description of the functionally equivalent portions will not be repeated here. In this configuration, an indicator element 296′ is provided separately from the sample element 164′ (i.e., the indicator element 296 is not integrated with the 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.

[0055] Referring to FIG. 12E, a fourth configuration of the sample element 164 is shown. The illustrated sample element 164''' is functionally equivalent to the sample elements 164, 164', and 164'' shown in FIGS. 12A, 12B, and 12D, and therefore a detailed description of the functionally equivalent portions will not be repeated here. Here, the transmission member 297''' and indicator 298 of the indicator element 296''' can be replaced with an optical fiber, hereinafter referred to as an indicator fiber. The indicator fiber functions to emit light in response to detection of target tissue by the controller 204. The sample element 164''' can also include an indicator portion 291 illuminated by the indicator fiber as light travels down the sample element 264'''. The indicator portion 291 may be located proximal to the distal portion of the sample element 164 to allow a medical professional to view the indicator portion 291 when ablating tissue. Indicator portion 291 may be transparent or may correspond to a removed portion of jacket 292 of sample element 164. The indicator fiber is coupled to optical block 216 via an optical connector and can receive light of a different wavelength than the excitation light from excitation source 228 or another excitation source. For example, the excitation source can generate green light (e.g., a wavelength of approximately 520-564 nm) when commanded by controller 204 to indicate detection of target tissue.

[0056] 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 disposed within the central core, while the indicator fiber is disposed within the outer channel. A portion of the jacket 292 of the sample element 164''' may be removed to allow the indicator fiber to shine light through a sidewall of the outer channel to illuminate the indicator portion 291.

[0057] In response to detecting target tissue, the controller 204 can send an activation signal to the indicator 298. The indicator 298 can emit light in response to receiving the activation signal. The controller 204 can control the LED to emit different colors of light depending on whether the controller 204 detects PPIX or ICG (i.e., whether the brain tissue 111 corresponds to target tissue or a blood vessel). For example, the controller 204 can control the LED to emit green light (e.g., a wavelength of about 520-564 nm) when PPIX above a threshold is detected, or yellow light (e.g., a wavelength of about 565-590 nm) when ICG is detected.

[0058] The spectrometer 224 is configured to convert the filtered optical signal (i.e., the filtered light) into a spectral signal in the form of an electrical signal. The microcontroller 220 is configured to control the operation of the spectrometer 224. Examples of spectrometer systems that can be used include the Mini-Spectrometer Micro Series C12880MA, available from Hamamatsu. While the spectrometer 224 is contemplated throughout this disclosure, other optical instruments may be used in place of the spectrometer 224. The spectrometer 224 may include an entrance slit, a collimating lens / mirror, a transmissive diffraction grating element, a focusing mirror, and an image sensor. The entrance slit receives the collected light from the optical block 216, after which the light passes through the collimating lens / mirror. The collimating lens / mirror collimates the collected light that passes 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 and transmits or reflects each wavelength of light at a different diffraction angle. A focusing lens or mirror images the light dispersed into wavelengths by the diffraction grating element onto linearly arranged pixels of the image sensor according to wavelength.

[0059] Each wavelength is photoelectrically converted into an electrical signal (spectral signal). The image sensor outputs a signal of the light incident on each pixel at a regular time interval (i.e., the image sensor converts the optical signal into an electrical signal and outputs it). This time interval is sometimes called integration timing. The microcontroller 220 may be configured to control the operation of the spectrometer 224, for example, the integration timing based on instructions from the controller 204. The microcontroller 220 transfers the spectral signal to the controller 204 via a communication interface (e.g., a serial peripheral interface (SPI)).

[0060] The controller 204 is configured to convert the spectral signals provided by the microcontroller 220 into simple / usable output variables in real time to provide the medical professional with an indication of the presence of target tissue within the sterile field. The controller 204 may illuminate an indicator 298 on the sample element 164 in response to detecting target tissue.

[0061] Because ambient light may be present in the optical signal collected at the target tissue, and therefore in the spectral signal provided by the spectrometer 224, the controller 204 is configured to perform one or more control functions or methods to remove the ambient light from the spectral signal (i.e., wavelengths associated with the ambient light) to accurately detect when the brain tissue 111 corresponds to the target tissue as evidenced by PPIX present in the target tissue.

[0062] 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 source 228 such that an alternating spectral signal is collected. During a first time period, the controller 204 may operate the excitation source 228 in a first illumination state (IS1) in which the excitation source 228 is on and irradiating the target tissue via the detection fiber 264. During a second time period, the controller 204 may be configured to operate the excitation source 228 in a second illumination state (IS2) in which the excitation source 228 is off and not irradiating the target tissue via the detection fiber 264.

[0063] The resulting spectral signal from the optical signal provided by the spectrometer 224 and collected from the target tissue while the excitation source 228 is in the first illumination state (IS1) for a first time period should include red fluorescence when the brain tissue 111 corresponds to the target tissue. The spectral signal received by the controller 204 during the first time period while the excitation source 228 is in the first illumination state (IS1) may hereinafter be referred to as the excitation spectral signal. Referring to FIG. 13, an excitation spectral signal 356 corresponding to red fluorescence collected during the first time 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, the surgical lamp, or any other equipment in the operating room, the excitation spectral signal 356 exhibits a wide range of wavelengths present in addition to those associated with red fluorescence. Referring to FIG. 10B, the light collected by the detection fiber 264 passes through a component 232, such as a long-pass filter, in the second section 284 of the optical block 216. After the light passes through component 232 , the light can enter spectrometer 224 , which is coupled to optical block 216 .

[0064] The spectral or spectrometer signal generated as a result of the optical signal provided by spectrometer 224 and collected from the target tissue while excitation source 228 is in the second illumination state (IS2) may include ambient light and should not include red fluorescence generated by the target tissue, even though the excitation light must be absorbed by the target to cause the tissue to fluoresce. The spectral signal received by controller 204 during the second time period while excitation source 228 is in the second illumination state (IS2) may be referred to as the ambient spectral signal.

[0065] 14A and 14B, a first modified spectral signal 360 and a second modified spectral signal 368 of a 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., the 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 provided under the second illumination condition (IS2) from the spectral signal provided under the first illumination condition (IS1)). After the first modified spectral signal 360 is generated, the controller 204 may be configured to further subtract any background signal still present from the first modified spectral signal 360.

[0066] The controller 204 may be configured to subtract any background signal still present in the first modified spectral signal to generate a second modified spectral signal. For example, the controller 204 may be configured to use a polynomial-based algorithm, such as an automated polynomial fitting routine based on a modified version of a least-squares polynomial, to obtain a baseline curve 364 representing any background signal still present. Using the algorithm, the controller 204 may then subtract the baseline curve 364 from the first modified spectral signal 360 to obtain a second modified spectral signal 368 representing red fluorescence emitted from the target tissue with ambient and background light removed.

[0067] The controller 204 may be configured to fit at least one Gaussian distribution / curve to the spectral signal. The controller 204 may fit at least one Gaussian distribution to the raw spectral signal (i.e., the excitation spectral signal and / or the ambient spectral signal), the first modified spectral signal, or the second modified spectral signal. This may allow a confidence level to be determined based on the fitting results. In FIG. 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 light and background light have been removed).

[0068] 16, the controller 204 can be configured to select a Gaussian band fitted to the emission band of PPIX (i.e., the band including 635 nm) and generate the selected band 372 for display in real time so that the medical professional can view the PPIX intensity in real time as the sample element 164 collects the sample. The controller 204 can store a predetermined intensity threshold associated with the target tissue.

[0069] The controller 204 can be configured to generate an activation signal based on a comparison of the PPIX intensity in the Gaussian-band-fitted PPIX emission band with a predetermined intensity threshold. In response to the PPIX intensity exceeding the threshold, the controller 204 can generate the activation signal. Based on the activation signal, the indicator 298 of the sample element 164 can emit light, thereby providing a medical professional with a real-time indication of the presence of target tissue.

[0070] The controller 204 may be configured to perform an error correction process before generating the actuation signal. During the error correction process, the controller 204 may be configured to determine a ratio of any of the spectral signals (raw spectral signal, excitation spectral signal, ambient spectral signal, first modified spectral signal, or second modified 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 intensities). If the ratio exceeds a threshold value (e.g., 2 percent), the controller 204 may be configured to return that the PPIX intensity has fallen below the threshold value, and therefore, the controller 204 does not generate the actuation signal, even if the actuation signal would have been generated before the error correction process was performed.

[0071] In parallel, another error check may be performed that examines the error between the spectrometer signal to be fitted and the result of the band fitting process. This error check is calculated only at specific points along the spectrometer signal to determine the intensity at the center and outermost points of the band (acceptable width). This intensity may be compared to the amplitude of the fitted band, which results in a percentage error that is compared to a predetermined value, and then compared to that amplitude. This allows the system to be more specific in determining whether the final fitted band is acceptable and reduces the number of false positives—indications that the indicator identifies tissue as tumorous when, in fact, the tissue is not tumorous.

[0072] As previously described, the controller 204 is configured to perform one or more functions or control methods to remove ambient light from the spectral signal (i.e., wavelengths associated with ambient light) and accurately detect when brain tissue 111 corresponds to target tissue as evidenced by PPIX present in the target tissue. The spectral or spectrometer signal provided by the spectrometer 224 and generated as a result of the optical signal collected from the target tissue while the excitation source 228 is in the second illumination state (IS2) may include ambient light. FIG. 31 shows an exemplary flowchart 500 for distinguishing brain tumor tissue from healthy brain tissue according to the teachings of the present disclosure. As will be appreciated from the subsequent description below, this flowchart represents an exemplary and non-limiting sequence of blocks describing a flowchart for distinguishing brain tumor tissue and is not intended to serve as a complete functional block diagram of all steps.

[0073] In step 502, the controller is configured to obtain a first signal based on the spectrometer signal from the spectrometer 224 and, in step 504, perform a calibration routine, if necessary. The controller 204 may be configured to perform the calibration routine as described in more detail below. In some configurations, the calibration routine may include multiplying by a calibration value. It is contemplated that the calibration routine is separate and optional. In step 506, the controller is configured to check whether the data from the spectrometer signal and / or the first signal is within a range of interest. To do this, the controller 204 may be configured to check whether the data (e.g., pixels, values) is saturated. In step 508, the controller 204 is configured to calculate a second signal by removing the effects of ambient light from the spectrometer signal. In some configurations, to remove the effects of ambient light, the controller is configured to discard data that is not within a range of interest.

[0074] In step 510, the controller 204 is configured to fit multiple bands to the second signal. In other configurations, the controller 204 may fit only a single band. In step 512, the controller 204 is configured to select a fitting band. The controller 204 may select a fitting band from the multiple fitted bands, one or more parameters of the fitted bands, based on, for example, an average value criterion, a standard deviation criterion, a maximum value, a minimum value, a bandwidth criterion, or a combination thereof. The controller is configured to select a fitting band associated with a PPIX emission band. For example, the controller is configured to select a fitting band exhibiting an average value criterion of 635 nm. In another example, the controller is configured to select a fitting band from the multiple fitted bands based on an average value criterion and a standard deviation criterion. The standard deviation criterion may vary, for example, within one or two standard deviations.

[0075] More specifically, the controller 204 may fit multiple distribution curves to the second signal, where the distribution curves are further defined as multiple Gaussian distribution curves, multiple Lorentzian distribution curves, or a combination thereof. Other types of known distributions may be used for band fitting. Alternatively, the distribution curves may be fitted using other types of regression modeling.

[0076] In step 514, the controller may determine the intensity of the selected fitting band and control the indicator 298 based on the intensity of the selected fitting band. Once selected, in some configurations, the controller 204 is configured to control the indicator 298 based on the intensity of the selected fitting band and a predetermined threshold. For example, in some configurations, the predetermined threshold may be an intensity threshold.

[0077] The controller 204 may be further configured to calculate an amplitude offset based on the amplitude of the second signal and the selected fitting band, and to control the indicator 298 based on the amplitude offset and an amplitude offset threshold. The second signal is a result of the spectrometer signal after windowing and after removing the effects of ambient light on the spectrometer signal. In these configurations, the controller is configured to calculate the amplitude offset based on the center of the selected fitting band.

[0078] In some configurations, the controller is configured to calculate the second signal by fitting a baseline polynomial curve to the spectrometer signal and subtract the baseline polynomial curve from the spectrometer signal to remove ambient light artifacts, resulting in the second signal.

[0079] Once the intensities of the selected fitting bands are determined in step 516, the controller 204 is configured to control the indicator 298 based on the intensities of the selected fitting bands. Generally, as one example, the controller 204 is configured to calculate a signal by removing the effects of ambient light from the spectrometer signal, identify a single band associated with PPIX based on the second signal, and control the indicator 298 based on the intensity of the single band. In some configurations, the single band may be a band corresponding to the emission of a single fluorophore. In other configurations, the single band may be a band corresponding to PPIX based on the spectrometer signal. As another example, the controller 204 is configured to calculate a signal by removing the effects of ambient light from the spectrometer signal, identify at least two bands associated with PPIX based on the second signal, and control the indicator 298 based on the intensities of the multiple bands. In some configurations, the at least two bands may be bands corresponding to the emission of a single fluorophore. In other configurations, the controller may be used for fluorophores other than PPIX.

[0080] Steps 502-516 of method 500 may be repeated, thereby creating a loop that is broken only when necessary. It is noted that some steps are described as being performed "when necessary." This is intended to indicate that those steps may be omitted or optional.

[0081] The controller 204 can communicate with the ultrasonic surgical console via a communication link established through the electrical port 174. For example, a cord can be plugged into the electrical port and also into the ultrasound control console 128 to establish a communication link. 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 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 ablation rate may not be limited, but if target tissue is not present, the ablation rate may be limited to prevent the ultrasonic surgical handpiece from cutting healthy tissue. In such an example, the ultrasound console can control a drive signal, such as voltage, current, or both, supplied to the ultrasonic handpiece based on whether target tissue is detected. In this example, the controller 204 may communicate with the ultrasound control console 128, but the controller 204 may alternatively communicate with the surgical control console 115 to control various surgical instruments (e.g., bipolar forceps 160, nerve stimulators, dissectors, ablation devices, etc.) based on the presence or absence of target tissue.

[0082] The controller 204 may be configured to execute one or more standardization and / or calibration routines. The controller 204, via the user interface 208, prompts the medical professional to execute a calibration routine at the beginning of the ablation procedure to account for variations in autofluorescence of the brain tissue 111 from person to person. The controller 204 may instruct the medical professional to collect light from known healthy brain tissue 111 using the detection fiber 264 of the sample element 164 to use as a standard baseline. Based on characteristics of the collected light, the controller 204 may adjust one or more parameters of an algorithm for determining whether the brain tissue is tumorous, such as a predetermined intensity threshold in PPIX.

[0083] In the standardization routine, during a first time period, the controller 204 may instruct the medical professional to use the detection fiber 264 of the sample element 164 to collect light from a light source (e.g., a nearby light source) that outputs light from a consistent spectral band. 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 may store the first standardized electrical signal, which represents a characteristic of the collected light. During a second time period that occurs after the first time period, the controller 204 may 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 may compare the first standardized signal obtained during the first time period with the second standardized signal obtained during the second time period and use the result to account for any variations in the optical readings over time. For example, the controller 204 may adjust one or more parameters of an algorithm used to determine whether brain tissue is tumorous or one or more settings of the spectrometer 224 to account for any variations in the optical readings over time.

[0084] Returning to reference, Figure 17 includes a flowchart 400 illustrating a surgical ablation procedure in accordance with the teachings of the present disclosure. As will be appreciated from the following discussion, this flowchart merely represents a typical, non-limiting sequence of blocks for describing a typical ablation procedure performed to ablate targeted tissue, and is in no way intended to serve as a complete functional block diagram of all steps of the ablation procedure.

[0085] The ablation procedure 400 begins at 404, where a medical professional may identify target tissue using the surgical microscope 108 under excitation light. After the target tissue is identified at 408, the medical professional may perform ablation of the target tissue using one of the surgical instruments described above. At 412, after ablation of the target tissue identified via the surgical microscope, the medical professional determines whether there is any suspect brain tissue that may correspond to the target tissue (e.g., tissue that does not emit visible light when viewed through the surgical microscope 108 under excitation but has properties associated with the target tissue). If no suspicious brain tissue is present, the ablation procedure may end; if not, the ablation procedure proceeds to 416.

[0086] At 416, the medical professional engages the sample element 164 with the suspected brain tissue (e.g., 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 of the sample element 164. If yes, the ablation procedure proceeds to 424; if not, the ablation procedure continues back to 412. At 424, the medical professional applies an electrical stimulus to the target tissue. At 428, the medical professional determines whether the electrical stimulus affected the patient. If yes, the medical professional can choose not to ablate the target tissue; if not, the ablation procedure continues back to 408.

[0087] 18-21, the sample element 164 may be coupled to any surgical instrument. The sample element 164 may be coupled to an ultrasonic handpiece assembly 130 as shown in FIGS. 18A and 18B, to a bipolar forceps 160 (or any surgical instrument associated with the surgical system 112, such as a dissector) as shown in FIGS. 19A and 19B, or to a suction fitting 156 as shown in FIGS. 20-22. The sample elements 164 and 164′ and / or indicator element 296 may be coupled to the surgical instrument in any suitable manner. For example, the sample element 164 (or sample element 164″ and indicator element 296″) may be coupled to the surgical instrument via an adhesive. The adhesive may be in the form of a sticker, glue, or other substance. Additionally or alternatively, the sample element 164 (or the sample element 164'' and the indicator element 296'') may also be coupled to the surgical instrument via a fixation element, which is described in more detail with respect to FIG. 22, or via a jacket, which is described in more detail with respect to FIGS. 21 and 22.

[0088] As shown in FIG. 18B , the sample element 164′″ can be coupled to the ultrasonic handpiece assembly 130 in any manner, so 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 terminate in a portion of the sleeve 136 proximal to the tip 140. In another example, the sample element 164′″ can extend beyond the sleeve 136, but can be positioned such 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′″.

[0089] 19A and 19B, the sample element 164'' is shown coupled to an outer portion of the first pincer 302 of the bipolar forceps 160, and the indicator element 296'' is shown coupled to an 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, allowing the medical professional to view the indicator 298'' without looking at another screen or portion of the instrument when performing the excision of the target tissue.

[0090] 20, 21, and 23, the sample element 164 is shown coupled to the suction instrument 156. The detection fiber 164 and a portion of the indicator element 296 (i.e., the transmission element 297 and the indicator 298) may 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 aspiration cannula 157. 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. In other words, the distal end 162 of the detection fiber 264 may be positioned proximal to the distal end of the aspiration cannula 157. 21 , after the detection fiber 264 and a portion of the indicator element 296 are fed through the through-hole 171, a jacket 306 can be attached over the aspiration cannula 157, the detection fiber 264, and the transmission element 297. The jacket 306 can be fitted to the distal end 162 of the handle 159 such that the distal end 162 and the through-hole 171 are covered. The jacket 306 can terminate just before the indicator 298 is coupled to the aspiration cannula 157. The detection fiber 264 can protrude from under the jacket 306 so that the jacket 306 does not interfere with the delivery of excitation light or the collection of fluorescence from the tissue. Also, as shown, the indicator 298 can be fully exposed but partially covered by the jacket 306. In some configurations, the jacket 306 can be omitted.

[0091] Referring to FIG. 22 , a different configuration of the suction tube 156′ is 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 apparatus 156′ via a fastening element 308. Specifically, the sample element 164′″ is shown coupled to the suction cannula 157′ by two fastening elements. Although only two fastening elements 308 are shown, three or more fastening elements 308 can be used to couple the sample element 164 to the suction cannula 157′ or to the handle 159′. The fastening elements 308 can include a clip, a band, or anything capable of securing the sample element 164 to the suction apparatus 156′.

[0092] 23, the transmission member 297 may be connected to a second indicator 299. The second indicator 299 may include one or more light-emitting diodes or other suitable light sources. The second indicator 299 may be positioned proximal to the distal portion of the sample element 164 and / or relative to the indicator 298 to allow a medical professional to view the second indicator 299 when the medical professional is excising tissue. The second indicator 299 is configured to emit light to indicate that the sample element 164 and / or the suction tube 156 are properly functioning and / or connected. In some configurations, the second indicator 299 may emit an orange light (e.g., a wavelength of approximately 585-620 nm). In this way, medical personnel can verify whether a tumor or target tissue is detected via indicator 298 and whether sample element 164 and / or suction tube 156 are functioning properly or connected via second indicator 299, and can also easily distinguish between the colors of indicator 298 and second indicator 299.

[0093] 24-27, different configurations of a sample element 164'''' coupled to an aspiration tube 166'' are shown. Specifically, the aspiration tube 166'' includes a through-hole 171' in the handle 159'' of the aspiration tube 166''. The illustrated sample element 164'''' is functionally equivalent to the sample elements already shown throughout the figures, and therefore a detailed description of the functions of equivalent parts will be omitted. A connector line 309 may be guided through the through-hole 171' in the handle 159''. The connector line 309 may include the cable 144 or other cable and / or a power cord. For example, the connector line 309 may comprise a power connector or adapter configured to couple the aspiration tube 166'' to a power source. In some configurations, the detection fiber 164 and a portion of the indicator element 296 (i.e., the transmission element 297 and the indicator 298) may be guided through the through-hole 171' in the handle 159'. The distal end 272 of the detection fiber 264 may be located proximal to the distal end of the suction tube 166''.

[0094] Referring to FIG. 24, the sample element 164'''' is shown covered by a jacket 292'. The jacket 292' may be fitted over the upper end of the suction element 156'' or a portion of the suction element 156'', the detection fiber associated with the sample element 164'''', and the transmission element associated with the sample element 164''''. In some configurations, the jacket 292' may be fitted over the distal end of the suction element 156'' such that a portion of the suction element 156'' is covered. FIG. 25 shows the suction element 156'''' with the jacket 292' omitted for illustrative purposes to show at least one of the connector line 309, the detection fiber, or the transmission element associated with the sample element 164''''.

[0095] With further reference to FIG. 25 , as shown in FIG. 26B , the outer profile of the suction tube 166″ defines an outer channel 314. The outer channel 314 of the suction tube 166″ may be positioned along any suitable or selected portion of the suction tube 166″. The detection fiber 164 may pass through the outer channel 314 and be directed toward the distal end of the suction tube 166″. In some configurations, the outer channel 314 is configured to accommodate a single optical fiber. In various configurations, the suction tube 166″ may form one or more outer channels 314. Thus, a channel may be formed by a combination of the sample element 164, 164′, 164″, 164′″ and the suction tube 166″, or by either one alone. It will be appreciated that the outer channel 314 may be provided as the only or single passage along the majority of the length of the suction tube 166″.

[0096] As shown in FIG. 27 , the outer channel 314 extends to the distal end of the suction tube 166″. The distal end of the suction tube 166″ may have a circular outer profile with an outer surface 316 and a lumen 318. The lumen defines a circular cross-section. In some configurations, the outer surface 316 of the suction tube 166″ defines the outer channel 314 for accommodating a cable, i.e., a single optical fiber. For example, in a configuration in which the outer surface 316 of the suction tube 166″ defines the outer channel 314, a connector 310 including a single optical fiber and an electrical terminal is at least partially disposed within the outer channel 314. Alternatively or additionally, as best shown in FIGS. 25-26B , a tube (e.g., heat shrink tube) or sleeve 312 may be disposed over at least a portion of the suction tube 166″, including the outer channel 314. As a result of the heat shrink tubing over the outer channel 314, the cable or single optical fiber housed by the outer channel 314 is held by the tubing to the suction tube 166''. In this manner, the fiber and / or electrical conductors are secured between the suction tube 166'' and the sleeve 312. In some configurations, the electrical conductors extend through the heat shrink tubing and are in electrical communication with the indicator 298 and the electrical terminal 315. Other configurations are also contemplated. In some configurations, the electrical terminal 315 is coupled to an optical indicator, and the single optical fiber 311 is in optical communication with the distal end of the single optical fiber 311. In such a configuration, the surgical instrument includes an aspiration line, and the aspiration line is connected to the connector line 309.

[0097] 28 and 29, another configuration of a portion of the optical block 216′ is shown. The optical block 216′ may include an outer casing constructed of metal or other suitable material, which may completely surround the components 232′ of the optical block 216′. FIGS. 28 and 29 show the optical block 216′ with the top of the casing removed to reveal the components of the optical block 216′. The optical block 216′ defines a first portion 320 extending from the connection port 322 to a first junction 324, an emission portion 326 (best shown in FIG. 29) extending from the first junction 324 to an illuminant or excitation source 328, and a detector portion 330 extending from the first junction 324 to the spectrometer 224. In some configurations, a fiber lens 332 is disposed in the first portion 320, and one or more spectrometer lenses 324 are disposed in the detector portion 330. The illuminant 328 may be disposed in the emission portion 326.

[0098] In some configurations, a connector line 309 extends from the suction tube 166'' and a connector 310 is coupled to the connector line 309. The connector 310 includes a single optical fiber 311 and an electrical terminal 315. The connector 310 is configured to connect to a surgical console (e.g., control console 168) that includes a light source or excitation source and a controller (e.g., controller 204). As shown in FIG. 29, the connector 310 may be configured to couple to a connection port 322 of an optical block 216'.

[0099] The optical block 216′ may include other optical components, such as one or more mirrors, lenses, optical connectors, optical fibers, and / or other suitable optical components. For example, in some configurations, the optical block 216, 216′ may include three lenses. In some configurations, the three lenses have the same focal length for transmitting light from the light emitter or excitation source to the detection fiber and from the detection fiber to the spectrometer 224. Meanwhile, in other configurations, the three lenses may have different focal lengths. For example, the focal length of a lens associated with the light emitter 328 or excitation source 228 may be different from the focal length of at least one of the lenses associated with the spectrometer 224 or the detection fiber. In other cases, the focal length of a lens associated with the light emitter 328 or excitation source 228 may be longer than the focal length of either the lens associated with the spectrometer 224 or the detection fiber. In other cases, the focal length of a lens associated with the light emitter 328 or excitation source 228 may be longer than both the lenses associated with the spectrometer 224 and the detection fiber. For example, the focal length of the lens associated with the light emitter 328 or excitation source 228 may be 50 mm, the focal length of the lens associated with the spectrometer 224 may be 25 mm, and the focal length of the lens associated with the detection fiber may be 30 mm. Other focal lengths are contemplated, and it may be understood that the focal lengths may vary.

[0100] In some configurations, the optical block 216' includes at least a spacer, which may be configured as a C-shaped member 334 positioned between at least two lenses and / or filters and / or optical components. In some configurations, the C-shaped member may alternatively be shaped as a cylinder. Other shapes and configurations are also contemplated. In some configurations, the spacer 334 may be configured to function as a spacer between lenses to maintain the distance or spacing between the lenses. The optical block includes cylindrical channels drilled to a specific diameter. Once an optical component, such as a lens or filter, is in place within the cylindrical channel, the spacer slides into the cylindrical channel, maintaining the distance / spacing between the optical components. When a C-shaped member is used, the C-shaped member compresses during insertion, allowing the C-shaped member to fit snugly within the cylindrical channel. This prevents the spacer from rattling during insertion. The C-shaped member may be made of metal or plastic.

[0101] An adjustable screw assembly may be incorporated into the optical block 216′ to control the position of the spectrometer 224 and / or the light emitter 328 for alignment purposes. As shown in FIG. 30 , an adjustment mechanism 336 is provided for adjusting the position of the spectrometer 224 and / or the light emitter 328. The adjustment mechanism 336 includes a first adjustment member 338 for adjusting the position of the spectrometer 224 in a first degree of freedom and a second adjustment member 340 for adjusting the position of the spectrometer 224 in a second degree of freedom. The first and second adjustment members 338, 340 may be screws. It is contemplated that the first and second adjustment members 338, 340 may be any type of adjustable component. It is further contemplated that other features of the optical block 216′, such as additional adjustment members, may be provided to align the center of the spectrometer 224 with the center of the light beam. For example, in some configurations, the adjustment mechanism 336 further includes a third adjustment member 342 configured to lock the position of the spectrometer 224 and / or the light emitter 328 once those components are aligned. In this manner, the light source and sensor are aligned for optimal emission and / or collection.

[0102] 32-41, another alternative configuration of the suction instrument 1156 is shown. The suction instrument 1156 includes a suction tube 1166 or tubular member and a handle 1159. The suction tube 1166 defines a lumen 1318 for aspirating fluid, debris, and tissue from a patient. The handle 1159 has a control 1167, which may be contoured to allow a medical professional to more easily grip the handle 1159. The suction instrument 1156 is described as having a Fukushima configuration, but other configurations, such as a Frazier configuration or a Poole configuration, are also contemplated. As shown here, the suction tube 1166 may be curved generally downward along its length. The suction tube 1166 curves downward to provide a more ergonomic grip for a surgeon manipulating the suction instrument 1156. The suction tube 1166 is divided approximately midway along its length into an upper or first side and a lower or second side. The first side is generally the side that is on the outside of the direction of curvature, and the second side is generally the side that is on the inside of the direction of curvature.

[0103] The distal end 1162 of the handle 1159 may be tapered and configured to receive the proximal end of the suction tube 1166. The proximal end 1165 of the handle 1159 includes a vacuum fitting that may be configured to receive a suction hose connected to a vacuum source that generates suction pressure. The vacuum fitting may be a standard barbed fitting, a quick disconnect, or any other suitable fitting known in the art that allows the suction hose to be fluidly coupled to the vacuum source. Specifically, the suction instrument 1156 includes an internal passageway 1171 ( FIG. 41 ) in the handle 1159 of the suction instrument 1156 for receiving the sample element 1264, as described in more detail below. The sample element may be disposed in a connector line 1309, which may be guided through the internal passageway 1171 of the handle 1159. The connector line 1309 may include a cable and / or a power cord.

[0104] The control unit 1167 may include a teardrop-shaped controller 1170 for adjusting the suction pressure. For example, when no portion of the teardrop-shaped controller 1170 is covered by the medical professional, the suction pressure may be minimum, and when the teardrop-shaped controller 1170 is completely covered, the suction pressure may be maximum. Although the control unit 1167 is described as including a teardrop-shaped controller, the control unit 1167 may include another suitable input, such as a button or a differently shaped controller, that allows the medical professional to vary the suction pressure. The medical professional holds the suction instrument 1156 by its handle 1159 and manipulates the suction instrument 1156 so that the distal end 1163 contacts the patient's tissue during the surgical procedure to apply suction at the desired location.

[0105] 32-41 , another configuration of the sample element is shown, which includes a detection fiber 1264 coupled to the suction tube 1166 or tubular member. The illustrated sample element is similar to the sample elements described above, and therefore a detailed description of the functions of equivalent parts will not be provided. In some configurations, the detection fiber 1264 and a portion of the indicator element 1296 (i.e., the transmission element 1297 and the indicator 1298) may be guided through an internal passage 1171 of the handle 1159. The distal end 1272 of the detection fiber 1264 may be located near the distal end of the suction tube 1166. In some implementations, the detection fiber 1264 may use an optical fiber with a diameter of less than 500 μm.

[0106] Here, the transmission element 1297 and indicator 1298 of the indicator element 1296 comprise an optical fiber, hereinafter referred to as indicator fiber 1313. The indicator fiber 1313 serves to emit light in response to detection of target tissue by the controller 204. As shown here, the distal end 1317 of the indicator fiber 1313 may comprise an indicator portion 1291, which may be positioned near the distal portion of the suction tube 1166 or other instrument to allow a medical practitioner to view the indicator portion 1291 as the medical practitioner ablates the tissue. The indicator fiber 1313 may be coupled to the optical block 216, 216' via the optical connector 1229 and may receive light of a different wavelength from the excitation light from another excitation source, such as the excitation source 228 or a different light source. For example, a light source coupled to the indicator fiber may generate green light (e.g., a wavelength of approximately 520-564 nm) when instructed by the controller 204 to indicate detection of target tissue, such as tumor tissue. In some implementations, the indicator fiber 1313 may use an optical fiber with a diameter of less than 500 μm. Here, the indicator portion 1291 of the indicator fiber 1313 may include a textured surface to scatter transmitted light. The textured surface reduces internal reflections through the fiber and allows light to transmit through the radially outer surface of the indicator fiber 1313. The textured surface is formed by deforming the outer surface of the indicator fiber 1313 through a crimping process. The crimping process creates a textured surface that transforms the otherwise regular and smooth outer surface into a textured surface that allows reflected light to transmit along the indicator fiber 1313.

[0107] Other processes for forming the textured surface are also contemplated, and various textures are contemplated, such as threads, radial cuts, axial cuts, and combinations thereof. It should be understood that a portion of the core portion and a portion of the cladding layer may include a textured surface, thereby allowing light to be transmitted radially through the jacket. Details are described in U.S. Patent No. 9,067,050, which is incorporated herein by reference in its entirety.

[0108] As discussed above and best shown in FIG. 40 , the detection fiber 1264 and indicator fiber 1313 may be routed down the length of the suction tube 1166 through the handle 1159 of the suction instrument 1156. The optical fibers 1264, 1313 are received within the handle 1159 at the proximal end 1165 and exit at the distal end 1162. A strain relief feature 1233 is disposed around the optical fibers 1264, 1313 and engages the handle 1159 to limit the bend radius of the optical fibers 1264, 1313 where they meet the proximal end 1165 of the handle 1159. The optical fibers 1264, 1313 exit the proximal end 1165 of the handle 1159 at an angle relative to the longitudinal axis of the suction instrument 1156. This angled arrangement allows for a more direct path for the vacuum through the handle 1159 while positioning the optical fibers 1264, 1313 out of the surgeon's way to prevent tangling and clutter.

[0109] As described above, the indicator 1298 may be a visual indicator configured to emit light when the controller 204 determines that the intensity of a single band based on the collected light signal associated with the PPIX and with the effects of ambient light removed exceeds a predetermined threshold. The emitted light is ideally in the visible spectrum and contrasts with the tissue surrounding the suction tube 1166. For example, the emitted light may be orange or amber. In some cases, the light emitted from the indicator 1298 may be of a single intensity so that the surgeon can determine the on or off state of the indicator 1298. Alternatively, the indicator 1298 may emit light at an intensity corresponding to the intensity of the single band. In other words, if the intensity of the single band exactly equals the predetermined threshold, the indicator 1298 will emit only a small amount of light, and conversely, if the intensity is very high, the indicator 1298 will emit more light. As the intensity of the single band increases, the brightness of the indicator 1298 will increase accordingly. In one embodiment, the visual indicator emits light in a flashing or pulsing pattern. The rate or pattern of the pulses may vary depending on the intensity of the single band, in which case a light source coupled to the indicator fiber causes the indicator fiber to emit light or brightness according to the intensity of the single band.

[0110] In another implementation, indicator 1298 may be an audible indicator configured to emit a sound when the intensity of a single band based on a collected light signal associated with PPIX and with ambient light effects removed exceeds a predetermined threshold. In one embodiment, the sound emitted from the audible indicator may vary in pitch according to the intensity of the single band. In another embodiment, the sound may include an alternating or pulsed sound whose rate varies based on the intensity. In other words, the sound may include two sounds that alternate slowly for the intensity of the single band at or near a predetermined threshold and alternate more rapidly as the intensity of the single band increases. In yet another embodiment, the emitted sound varies in volume according to the intensity of the single band. Some implementations of indicator 1298 may utilize an audible indicator instead of a visual indicator. Other implementations of indicator 1298 may utilize an audible indicator in addition to a visual indicator. The audible indicator may take the form of a speaker that is integrated with the console, built into a display device, or connected directly or indirectly to the console via a wired or wireless connection.

[0111] Other implementations of the indicator 1298 may include a visual indicator positioned in a location visible to the surgeon but not coupled to the suction instrument 1156. For example, the surgeon may be wearing an augmented reality headset to assist in performing a neurosurgical procedure using augmented, alternate, or mixed reality. In one implementation, the surgeon may view the surgical site in augmented reality, and the indicator may display a visual indicator superimposed in the surgeon's field of view when the intensity of the PPIX band exceeds a predetermined threshold. In one embodiment, the augmented indicator may be a virtual light positioned at the distal end of the suction tube 1166. In another embodiment, the augmented reality indicator may use machine learning and artificial intelligence to identify the boundaries of the suction tube's location and function as a paintbrush to virtually change the color of fluorescent tissue displayed to the surgeon.

[0112] Generally, the distal end 1272 of the detection fiber 1264 functions as the light detector of the optical probe. The optical probe is configured to be positioned adjacent to the tissue of interest. Thus, the distal end 1272 of the detection fiber 1264 may be positioned near the distal end of the suction tube 1166. The indicator 1298 may be positioned near the distal end 1272 of the detection fiber 1264, but may be positioned closer to the distal end 1162 of the control section 1167 of the handle 1159 than the distal end 1272 of the detection fiber 1264. In other words, the distal end 1272 of the detection fiber 1264 may be positioned closer to the distal end of the suction cannula 1157 than the indicator 1298. In some cases, the distal end 1272 of the detection fiber 1264 may be aligned with the distal end of the suction tube 1166. That is, the distal end of the indicator 1298 , eg, the indicator fiber, may be positioned adjacent to the distal end 1272 of the detection fiber 1264 .

[0113] 35 and 41 , the outer profile of the suction tube 1166 may define a first outer channel 1314 and a second outer channel 1315. In the implementation shown here, the first outer channel 1314 of the suction tube 1166 may be located or disposed on a first side of the suction tube 1166. Similarly, the second outer channel 1315 may be located or disposed on a second side of the suction tube 1166. In other words, the first outer channel 1314 is disposed on a lower end side of the suction tube 1166, and the second outer channel 1315 is disposed on an upper end side of the suction tube 1166.

[0114] The detection fiber 1264 may pass through the first outer channel 1314 and be directed toward the distal end of the suction tube 1166. In the configuration shown here, the first outer channel 1314 is configured to accommodate a single optical fiber. In other configurations (not shown), the first outer channel 1314 may be configured to accommodate two optical fibers, for example, the detection fiber 1264 and the indicator fiber 1313. In this manner, both the detection fiber 1264 and the indicator fiber 1313 are at least partially disposed within the first outer channel 1314.

[0115] 36 , the first outer channel 1314 extends to the distal end of the suction tube 1166. The distal end of the suction tube 1166 may have a circular outer profile with an outer surface 1316 and a lumen 1318. The lumen 1318 defines a circular cross-section. In some configurations, the outer surface 1316 of the suction tube 1166 defines the first outer channel 1314 for accommodating the detection fiber 1264. For example, in a configuration in which the outer surface 1316 of the suction tube 1166 defines the first outer channel 1314, the first outer channel 1314 extends to the distal end of the suction tube 1166.

[0116] The indicator fiber 1313 passes through the second outer channel 1315 and is directed toward a position proximal to the distal end of the suction tube 1166. In other words, the indicator fiber 1313 is at least partially disposed within the second outer channel 1315, which extends along the length of the suction tube 1166 and terminates before the distal end of the suction tube 1166.

[0117] As mentioned above, the distal end 1272 of the detection fiber 1264 and the distal end 1317 of the indicator fiber 1313 may each be positioned at or near the distal end of the suction tube 1166. For example, FIG. 36 shows that the distal end 1272 of the detection fiber 1264 is aligned with the distal end of the suction tube 1166. Here, the distal end 1272 of the detection fiber 1264 is disposed on a first side of the suction tube 1166. More specifically, the distal end 1272 is disposed on a side of the suction tube 1166 in the direction of curvature of the suction tube 1166. In other words, the suction tube 1166 shown here is curved downward, and the distal end 1272 of the detection fiber 1264 is disposed on the lower or bottom side of the suction tube 1166.

[0118] 36, the distal end 1317 of the indicator fiber 1313 is disposed on a second side of the suction tube 1166, opposite the first side of the suction tube 1166. More specifically, the distal end 1317 is disposed on the side of the suction tube 1166 opposite the direction of curvature of the suction tube 1166. In other words, the suction tube 1166 shown here is curved downward, and the distal end 1317 of the indicator fiber 1313 is disposed on the upper or top side of the suction tube 1166.

[0119] 34-37 and 41-43, the suction apparatus 1156 may further include a sleeve surrounding the suction tube 1166, the detection fiber 1264, and a portion of the indicator fiber 1313. Specifically, in the implementation shown here, the suction apparatus 1156 may include a proximal sleeve 1312 and a distal sleeve 1319. The proximal sleeve 1312 is disposed on a portion of the outer surface 1316 of the suction tube 1166 proximal to the distal end of the suction tube 1166. Similarly, the distal sleeve 1319 is disposed on the outer surface 1316 of the suction tube 1166 at the distal end of the suction tube 1166. Each of the proximal sleeve 1312 and the distal sleeve 1319 may include a material that changes shape and / or size in response to heat. For example, the proximal sleeve 1312 and the distal sleeve 1319 may include heat shrink tubing. As a result of the sleeves 1312, 1319 covering the channels 1314, 1315, the optical fibers 1264, 1313 housed by the outer channels 1314, 1315 are held relative to the suction tube 1166 by the sleeves 1312, 1319. In this manner, the optical fibers 1264, 1313 are secured between the suction tube 1166 and the sleeves 1312, 1319. In such a configuration, the suction apparatus 1156 may include a suction line with the suction line connected to the connector line 1309.

[0120] As previously mentioned, the sleeves 1312, 1319 may comprise a heat shrink material having an unrecovered state in which the sleeves 1312, 1319 are expanded in size and a recovered state in which the sleeves 1312, 1319 are reduced in size. FIG. 42 shows a portion of the suction tube 1166 and a mandrel 1321, with the proximal sleeve 1312 spaced therefrom in its unrecovered state. To form the tube portion of the suction instrument 1156, the mandrel 1321 is placed in the outer channel 1314 of the suction tube 1166, and the sleeve 1312 is placed over the suction tube 1166 and mandrel 1321. Heat is applied to the sleeve 1312 to transition it from its unrecovered state shown in FIG. 42 to its recovered state shown in FIG. 43. Once the sleeve 1312 is in its recovered state, the mandrel 1321 is removed from the sleeve 1312, and the appropriate optical fiber 1264, 1313 is inserted into the channel 1314. The use of a mandrel 1321 when heating the sleeve 1312 prevents damage to the optical fibers due to excessive heat buildup. The distal sleeve 1319 may be applied in a similar manner. Alternatively, the distal sleeve 1319 may be formed separately and applied using an adhesive that further facilitates holding the optical fibers 1264, 1313 in their respective outer channels 1314, 1315.

[0121] As described above, the indicator 1298 may be a visual indicator that emits light in response to the intensity of a single band based on a collected light signal associated with PPIX and having the effects of ambient light removed exceeding a predetermined threshold. The indicator 1298 is coupled to the suction tube 1166 adjacent its distal end to enhance the visibility of the indicator 1298. To this end, a distal sleeve 1319 surrounding the indicator 1298 and the indicator fiber 1313 may include a material that at least partially allows the transmission of visible light. The distal sleeve 1319 may be a transparent or nearly transparent material that can protect the distal end of the suction tube 1166 and hold the optical fibers 1264, 1313 to the suction tube 1166. Because the distal sleeve 1319 allows the transmission of visible light, the surgeon can see when the indicator 1298 is illuminated and when it is not illuminated during use.

[0122] In contrast to the distal sleeve 1319, the proximal sleeve 1312 may comprise a material that substantially blocks the transmission of visible light. The proximal sleeve 1312 may be an opaque or nearly opaque material that can protect the distal end of the suction tube 1166 and hold the optical fibers 1264, 1313 to the suction tube 1166. The proximal sleeve 1312 blocks or substantially blocks the transmission of light, thereby shielding the optical fibers 1264, 1313 from any ambient light. While light transmission along the optical fibers 1264, 1313 is very efficient, a small amount of light may be able to penetrate the outer surfaces of the optical fibers 1264, 1313. Surrounding the optical fibers 1264, 1313 with the opaque sleeve 1312 enhances the contrast between on and off optical signals transmitted through the optical fibers 1264, 1313. In other words, the difference between an "on" state of the optical signal and an "off" state of the optical signal (i.e., no light is being transmitted) is more easily discernible not only by the controller, but also by a surgeon viewing the indicator.

[0123] A method of forming a handheld surgical probe including an optical fiber is also contemplated. The method includes providing a suction instrument body having an outer surface defining a lumen. The suction instrument body may be a suction instrument 156'''' as described elsewhere. The method may further include positioning a mandrel 1321 adjacent to the suction instrument body. The method may include positioning a first heat shrink tube (such as a preformed version of 312) to partially surround the suction instrument body and the mandrel 1321. The method may include applying heat to the first heat shrink tube to form a first deformed heat shrink tube 312 to surround a portion of the suction instrument body. The method may remove the mandrel 1321 so that it is not adjacent to the suction instrument body. The method may include routing an optical fiber 264''', 1313 between the suction instrument body and an inner diameter of the first deformed heat shrink tube 312. The method may include positioning a second modified heat shrink tube 1319 over the distal end of the suction device body to partially surround a portion of the suction device body and the optical fibers 312, 1313.

[0124] The method may further include preforming the second heat shrink tubing to form a second deformed heat shrink tubing before positioning the second heat shrink tubing over the distal end of the suction instrument body, the preforming step including applying heat to the second heat shrink tubing while the second heat shrink tubing is positioned around a second mandrel having a shape that matches the shape of the distal end of the suction instrument body.

[0125] As previously described, the second modified heat shrink tubing is formed from a transparent material and the first heat shrink tubing is formed from an opaque material, allowing light emitted from indicator fiber 1313 to be projected radially through the second modified heat shrink tubing near the proximal portion of the suction instrument.

[0126] The melting point of the optical fiber may be lower than the melting point of the first and / or second heat shrink tube. For example, the melting point of the optical fiber may be lower than 70°C or 80°C, while the melting point of the opaque and / or transparent heat shrink tube may be about 130°C or 140°C. The melting point of the optical fiber is at least 50°C lower than the melting point of the first and / or second heat shrink tube.

[0127] The inventors have recognized that this unique forming process provides the advantage of utilizing a very thin-walled heat shrink material without damaging one or more optical fibers. Utilizing such a heat shrink material near the distal portion of the suction instrument is advantageous because the thin-walled nature of the material prevents obstruction to the surgeon's line of sight. In some cases, the thickness of the transparent heat shrink tubing is less than the thickness of the opaque heat shrink tubing. The thickness of the transparent heat shrink tubing is at least 75% less than the thickness of the opaque heat shrink tubing. In certain cases, the thickness of the transparent heat shrink tubing is less than 2%, less than 1%, or less than 0.5% of the outer diameter of the distal end of the suction instrument body.

[0128] The method may include securing the second modified heat shrink tubing to the suction apparatus body using an adhesive, which may be ultraviolet curable.

[0129] The method may include positioning the optical fiber within a groove formed in an outer diameter of the suction instrument body. The method may include positioning a second modified heat shrink tube such that the second modified heat shrink tube partially surrounds the groove.

[0130] 45 , an exemplary optical connector 1229 is shown. The optical connector 1229 couples and connects the connector line 1309 to the optical system described in more detail above. The optical connector 1229 includes an outer shell 1410, shown here with half of the outer shell 1410 removed. One side of the optical connector 1229 receives the connector line 1309, including the detection fiber 1264 and the indicator fiber 1313, and the other side of the optical connector 1229, in one example, engages with an optical system within a surgical console. Note that the optical connector 1229 lacks electrical terminals, so the suction instrument 1156 and the indicator 1298 cannot conduct electricity within the patient's body during a neurosurgical procedure. The detection fiber 1264 and the indicator fiber 1313 each terminate in a ferrule 1412 that surrounds the optical fiber and facilitates engagement with components within the optical system. Typically, a ferrule 1412 is crimped onto the proximal-most end of each optical fiber before it is secured within the outer shell 1410. Eliminating electrical terminals from the device assembly allows the device assembly to be relatively inexpensive and eliminates the risk of transmitting electrical energy into the patient's body.

[0131] Each ferrule 1412 is supported in an interior 1414 of the optical connector 1229 and is radially spaced apart from one another. The ends of each ferrule 1412 are generally axially aligned with one another. To this end, the outer shell 1410 includes a socket 1416 for each ferrule 1412 to axially support the ferrule 1412 within the interior 1414. In the illustrated implementation, the optical connector 1229 further includes a spring 1418 disposed around one of the ferrules 1412, between the ferrule 1412 and one of the sockets 1416 of the outer shell 1410. The spring 1418 allows for axial and radial movement, and therefore misalignment, of the ferrule 1412 and optical fiber. The movement of the ferrule 1412 and optical fiber permitted by the spring 1418 allows the ferrule 1412 to move slightly within the interior 1414 of the optical connector 1229 when a medical professional inserts the optical connector 1229 into a surgical console. Because the ferrules 1412 and optical fibers can move or shift slightly, the outer shell 1410 can be manufactured without the high tolerances required to prevent a misaligned ferrule from damaging the optical system. In other words, if the ferrules were held tightly in a slightly misaligned position relative to the optical system, repeated connection and disconnection of the optical connector 1229 to the console could damage the console's optical system. By allowing one of the ferrules 1412 to float within the interior 1414 of the optical connector 1229, rigid shifting of the ferrules 1412 is avoided.

[0132] While the optical connector 1229 shown here does not have electrical contacts, the optical connector 1229 may include an RFID tag 1420 that can be read by the console. An RFID tag 1420 with non-transitory memory may be disposed inside the optical connector 1229 and coupled to the outer shell 1410. The RFID tag 1420 may include data stored in memory or other information or characteristics regarding the suction apparatus 1156 associated with the optical fibers 1264, 1313. For example, the RFID tag 1420 may include characteristics of the detection fiber 1264, such as optical transmission characteristics or peak efficiency, that can be used to adjust the detection algorithm of the console. In another example, the RFID tag 1420 may include characteristics such as the length or diameter of the optical fiber that can be used to adjust the detection algorithm. Adjusting the detection algorithm may include increasing or decreasing the intensity of the excitation light provided to the detection fiber 1264 to account for power dropoff at the distal end 1272 of the detection fiber 1264. The RFID tag 1420 may also include usage data, such as the number of times the suction apparatus 1156 has been connected or to different consoles. The usage data may include the time the suction device 1156 was used. Additionally, the RFID tag 1420 may contain manufacturing data such as a serial number, manufacturing date, expiration date, etc. that may be used by the console to analyze usage trends and prevent expired components from being used.

[0133] It should be understood that the devices, methods, and systems described throughout this specification may also be used with tissue types other than brain tissue, such as breast tissue, etc. In such circumstances, the systems may be referred to as surgical systems or methods rather than neurosurgical systems and methods.

[0134] While specific device and system constructions are discussed throughout, it should be understood that the fabric, heat shrink sleeves, can be used in combination with other types of devices, such as scalpels, electrosurgical devices (electrosurgical pencils, forceps, surgical burring devices, endoscopes, stereotactic frames, pointers, stylets, etc.).

[0135] Terms Clause 1 - An ultrasonic surgical system comprising: an ultrasonic handpiece assembly configured to remove brain tissue; a sample element coupled to the ultrasonic handpiece assembly and including at least one fiber configured to collect fluorescence emitted from the brain tissue; an indicator coupled to the ultrasonic handpiece assembly and configured to selectively emit light; and a controller configured to detect a type of brain tissue based on the 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.

[0136] Clause 2 - An ultrasonic surgical system of clause 1, wherein at least one fiber is coupled to an excitation source, and the 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.

[0137] Clause 3 - An ultrasonic surgical system according to clause 2, further comprising an optical system coupled to the controller and the sample element, the optical system including an excitation source and an optical detection system configured to convert the fluorescence into an electrical signal, and the controller detecting the type of brain tissue from the electrical signal.

[0138] Clause 4 - The ultrasonic surgical system of Clause 3, wherein the excitation source is further defined as a first excitation source, the fluorescence is further defined as a first fluorescence, and the electrical signal is further defined as a first electrical signal; the optical system further includes a second excitation source, the at least one fiber is configured to irradiate second excitation light from the second excitation source to induce second fluorescence emitted from the 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 the second type of brain tissue from the second electrical signal.

[0139] Clause 5 - The ultrasonic surgical system of clause 3, wherein the controller is configured to detect the type of brain tissue based on an algorithm.

[0140] Clause 6 - The ultrasound surgical system of clause 5, wherein the algorithm includes a calibration routine to be performed with respect to healthy tissue or baseline parameters.

[0141] 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.

[0142] Clause 8 - The ultrasonic surgical system of clause 7, wherein the algorithm includes fitting at least one Gaussian distribution to the modified electrical signal.

[0143] Clause 9 - An ultrasonic surgical system as in Clause 5, wherein the controller is configured to cycle the excitation source on and off, the sample element is configured to collect ambient light when the excitation source is off and not illuminating the 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 the brain tissue with fluorescence, and the algorithm includes subtracting the ambient light from the fluorescence.

[0144] Clause 10 - The ultrasonic surgical system of clause 1, wherein the ultrasonic handpiece assembly includes an ultrasonic handpiece and a sleeve, and the indicator is coupled to the sleeve.

[0145] Clause 11 - The ultrasonic surgical system of clause 1, further comprising an electrode configured to apply electrical stimulation to brain tissue, wherein the controller generates an alarm when the electrical stimulation results in a predetermined response from the patient.

[0146] Clause 12 - A surgical system comprising: a surgical instrument configured to remove brain tissue; a sample element coupled to the surgical instrument and including (i) at least one fiber configured to collect fluorescence emitted from the brain tissue; an indicator coupled to the surgical instrument and configured to selectively emit light; and a controller configured to detect a type of brain tissue based on the 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.

[0147] Clause 13 - The surgical system of clause 12, further comprising an optical system coupled to the controller and the sample element, the optical system including an excitation source coupled to at least one fiber, the at least one fiber configured to irradiate the brain tissue with excitation light from the excitation source to induce fluorescence emitted from the brain tissue and collect the fluorescence, 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.

[0148] Clause 14 - The surgical system of Clause 13, wherein the excitation source is further defined as a first excitation source, the fluorescence is further defined as a first fluorescence, and the electrical signal is further defined as a first electrical signal, the optical system further includes a second excitation source, the at least one fiber is configured to irradiate second excitation light from the second excitation source to induce second fluorescence emitted from the 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.

[0149] Clause 15 - The surgical system of clause 13, wherein the controller is configured to detect the type of brain tissue based on an algorithm.

[0150] Clause 16 - The surgical system of clause 15, wherein the algorithm includes a calibration routine to be performed with respect to healthy tissue or baseline parameters.

[0151] 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.

[0152] Clause 18 - The surgical system of clause 17, wherein the algorithm includes fitting at least one Gaussian distribution to the modified electrical signal.

[0153] Clause 19 - The surgical system of clause 15, wherein the controller is configured to cycle the excitation source on and off, the sample element is configured to collect ambient light when the excitation source is off and not illuminating the 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 the brain tissue with fluorescence, and the algorithm includes subtracting the ambient light from the fluorescence.

[0154] Clause 20 - The surgical system of clause 12, wherein the surgical instrument comprises a bipolar forceps.

[0155] Clause 21 - The surgical system of clause 12, wherein the surgical instrument comprises a neurostimulator.

[0156] Clause 22 - The surgical system of clause 12, wherein the surgical instrument comprises a nerve dissector.

[0157] Clause 23 - The surgical system of clause 12, wherein the surgical instrument comprises an ablation device.

[0158] Clause 24 - The surgical system of clause 12, wherein the controller is configured to control the surgical instrument by adjusting operating parameters of the surgical instrument based on the detection of the type of brain tissue.

[0159] Clause 25 - The surgical system of clause 12, further comprising an electrode configured to apply electrical stimulation to brain tissue.

[0160] Clause 26 - The surgical system of clause 25, wherein the controller generates an alarm when the electrical stimulation results in a predetermined response from the patient.

[0161] Clause 27 - A surgical aspiration system comprising: a suction instrument configured to apply a suction force to brain tissue; a sample element including at least one optical fiber coupled to the suction instrument and configured to collect fluorescence emitted from the brain tissue; an indicator coupled to the suction instrument and configured to selectively emit light; and a controller configured to detect a type of brain tissue based on the fluorescence and to activate the indicator in response to the type of brain tissue detected.

[0162] Clause 28 - The surgical aspiration system of clause 27, wherein 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 to induce fluorescence emitted from the brain tissue and collect the fluorescence.

[0163] Clause 29 - The surgical aspiration system of clause 28, further comprising an optical system coupled to the controller and the sample element, the optical system including an 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.

[0164] Clause 30 - The surgical aspiration system of Clause 29, wherein the excitation source is further defined as a first excitation source, the fluorescence is further defined as a first fluorescence, and the electrical signal is further defined as a first electrical signal, the optical system further includes a second excitation source, the at least one fiber is configured to irradiate second excitation light from the second excitation source to induce second fluorescence emitted from the 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.

[0165] 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.

[0166] Clause 32 - The surgical aspiration system of clause 31, wherein the algorithm includes a calibration routine to be performed with respect to healthy tissue or baseline parameters.

[0167] 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.

[0168] Clause 34 - The surgical aspiration system of clause 33, wherein the algorithm includes fitting at least one Gaussian distribution to the modified electrical signal.

[0169] Clause 35 - The surgical aspiration system of clause 31, wherein the controller is configured to cycle the excitation source on and off, the sample element is configured to collect ambient light when the excitation source is off and not illuminating the 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 the brain tissue with fluorescence, and the algorithm includes subtracting the ambient light from the fluorescence.

[0170] Clause 36 - The surgical aspiration system of clause 27, further comprising an electrode configured to apply electrical stimulation to brain tissue, wherein the controller generates an alarm when the electrical stimulation results in a predetermined response from the patient.

[0171] Clause 37 - The surgical aspiration system of clause 27, wherein the aspiration instrument includes a handle portion and an elongated portion, and the sample element is coupled to the elongated portion.

[0172] Clause 38 - A method for detecting target tissue under ambient light conditions in an operating room during a surgical procedure, comprising the steps of: positioning an optical fiber within a sterile field containing brain tissue illuminated by the ambient light; collecting, using the optical fiber, fluorescence emitted from the brain tissue; detecting, using a controller coupled to the optical fiber, target tissue in the brain tissue based on the fluorescence emitted from the brain tissue; and activating an indicator positioned within the sterile field in response to detection of the target tissue to generate a visual alert.

[0173] Clause 39 - The method of clause 38, wherein fluorescence is emitted from the brain tissue in response to irradiating the brain tissue with excitation light from an excitation source coupled to the optical fiber.

[0174] Clause 40 - The method of clause 39, wherein detecting fluorescence emitted from the target tissue during the surgical procedure is based on an algorithm.

[0175] 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.

[0176] Clause 42 - The method of clause 40, further comprising an optical system coupled to the optical fiber and the controller, the optical system configured to convert the fluorescence collected from the target tissue into an electrofluorescence signal.

[0177] Clause 43 - The method of clause 42, wherein the optical system includes a spectrometer.

[0178] Clause 44 - The method of clause 42, wherein the algorithm includes fitting a baseline polynomial curve to the electrofluorescence signal and calculating a corrected electrofluorescence signal by subtracting the baseline polynomial curve from the electrofluorescence signal to remove ambient light.

[0179] Clause 45 - The method of clause 44, wherein the algorithm includes fitting at least one Gaussian distribution to the corrected electrofluorescence signal.

[0180] Clause 46 - The method of clause 40, further comprising the steps of periodically turning on and off excitation light from the excitation source 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 comprises subtracting the ambient light from the fluorescence.

[0181] Clause 47 - The method of clause 38, wherein the optical fiber is incorporated into at least one of a surgical instrument and a stand-alone device.

[0182] Clause 48 - The method of clause 38, wherein the indicator comprises a light emitting device coupled to the surgical instrument.

[0183] Clause 49 - A method for detecting target tissue under ambient light conditions in an operating room using a surgical system, the surgical system comprising 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 the at least one optical fiber, the method for detecting target tissue comprising the steps of: positioning the working instrument in a sterile field containing brain tissue illuminated by ambient light; and detecting, using the optical system, fluorescence emitted from the target tissue during the surgical procedure using at least one optical fiber of the working instrument, wherein the step of detecting fluorescence comprises the steps of illuminating the tissue with blue light from the excitation source using at least one optical fiber; collecting the ambient light and the fluorescence using the at least one optical fiber; generating a fluorescence signal based on the fluorescence emitted from the target tissue with the ambient light removed; determining the presence of target tissue based on the detected fluorescence; and activating an indicator of the working instrument in response to the detection of the target tissue.

[0184] Clause 50 - The method for detecting target tissue of Clause 49, wherein the step of irradiating the tissue with blue light from an excitation source using at least one optical fiber is performed for a first period of time, the step of irradiating the tissue with blue light is not performed for a second period of time, the step of collecting ambient light and fluorescence is performed for a first period of time, and the step of detecting fluorescence further includes the steps of collecting ambient light for a second period of time using at least one optical fiber, and (i) generating a first signal based on the ambient light and fluorescence collected during the first period of time, and (ii) generating a second signal based on the ambient light collected during the second period of time, wherein the ambient light is removed from the fluorescence signal using an algorithm based on the first signal and the second signal.

[0185] Clause 51 - The method for detecting target tissue of clause 50, wherein the algorithm includes calculating a baseline curve using a least squares polynomial based on the difference between the first signal and the second signal.

[0186] Clause 52 - The method for detecting a target tissue of Clause 51, wherein the algorithm includes subtracting a baseline curve from the difference between the first signal and the second signal to obtain a fluorescent signal.

[0187] Clause 53 - The method for detecting target tissue of clause 52, wherein the algorithm comprises calculating at least one Gaussian curve for at least one spectral band of the fluorescent signal.

[0188] Clause 54 - The method for detecting target tissue of clause 49, wherein the working tool is a suction handle.

[0189] Clause 55 - A method for detecting target tissue according to clause 49, wherein the working instrument is an ablation device.

[0190] Clause 56 - The method for detecting target tissue of clause 55, further comprising the step of removing the target tissue based on the indicator using a working tool.

[0191] Clause 57 - The method for detecting target tissue of clause 49, wherein the ambient light comprises light generated by a surgical microscope and light generated by one or more surgical lamps.

[0192] Clause 58 - The method for detecting target tissue of Clause 49, wherein the surgical system includes a display, and the method further includes the step of displaying the fluorescent signal on the display.

[0193] Clause 59 - The method for detecting target tissue of Clause 49, wherein the working instrument includes at least one electrode configured to apply a stimulation current to the target tissue, and the method for detecting the target tissue includes the steps of applying an electrical stimulation to the target tissue and determining whether the electrical stimulation of the target tissue has an effect on the patient.

[0194] Clause 60 - A method for detecting target tissue of clause 59, wherein, in response to a determination that the electrical stimulation will affect the patient, operation of the working instrument is controlled to prevent the working instrument from acting on the target tissue.

[0195] Clause 61 - The method for detecting target tissue of clause 60, wherein controlling the operation of the work implement comprises varying an operating parameter of the work implement.

[0196] Clause 62 - The method for detecting target tissue of Clause 61, wherein the operating parameters include at least one of an applied voltage, a drawn current, and a power consumption.

[0197] Clause 63 - The method for detecting target tissue of clause 59, wherein the indicator is further defined as a first indicator and the working instrument includes a second indicator, and the method for detecting target tissue further comprises the step of activating the second indicator in response to determining that the electrical stimulation affects the patient.

[0198] Clause 64 - A method for detecting a target tissue of Clause 49, wherein the target tissue is further defined as a first target tissue, and the method further comprises the step of detecting a second target tissue using an optical system based on a second fluorescence emitted from the second target tissue.

[0199] Clause 65 - The method for detecting target tissue of clause 64, further comprising the step of controlling operation of the working instrument in response to detection of the second target tissue to prevent the working instrument from acting on the second target tissue.

[0200] Clause 66 - A method for detecting a target tissue according to clause 64, wherein the second target tissue corresponds to a blood vessel.

[0201] Clause 67 - A method for detecting target tissue according to clause 49, wherein the detection of fluorescence is carried out in less than 1 second.

[0202] Clause 68 - A method for detecting and removing target tissue under ambient light conditions in an operating room 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 the at least one optical fiber, the method for detecting target tissue comprising 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 coupling the attachment to at least one of the first working instrument and the second working instrument. and a second working instrument are in a sterile field; activating an indicator on the attachment in response to detecting the target tissue; viewing the indicator on the attachment while at least one of the first working instrument and the second working instrument are in the sterile field; performing a first surgical procedure at the surgical site while the first working instrument is in a first hand of a surgeon; and performing a second surgical procedure at the surgical site while the second working instrument is in a second hand of the surgeon in response to the indicator while holding the first working instrument in the first hand.

[0203] Clause 69 - The method for detecting and removing target tissue of clause 68, wherein the first working instrument corresponds to a suction cannula and the first surgical procedure includes aspirating fluid from the surgical site.

[0204] Clause 70 - The method for detecting and removing target tissue of clause 68, wherein the second working instrument corresponds to a bipolar forceps.

[0205] Article 71 - A method for detecting and removing target tissue under ambient or microscopic light conditions in an operating room using a surgical system, the surgical system comprising: an aspiration cannula including at least one optical fiber; an indicator; a working instrument; an optical system; and an excitation source coupled to the at least one optical fiber, the method comprising: positioning the working instrument and the aspiration cannula in a sterile field containing brain tissue illuminated by ambient light; detecting the target tissue during the surgical procedure based on fluorescence emitted from the target tissue using the optical system; activating an indicator on the aspiration cannula in response to detection of the target tissue while the aspiration cannula is in the sterile field; viewing the indicator on the aspiration cannula while the aspiration cannula is in the sterile field; aspirating fluid from the surgical site using the aspiration cannula while the aspiration cannula is in a first hand of the surgeon; and operating on the target tissue using a working instrument in the second hand of the surgeon in response to the indicator while holding the aspiration cannula in the first hand of the surgeon.

[0206] Clause 72 - A method for detecting target tissue under ambient light conditions in an operating room using a surgical system, the surgical system comprising 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 the at least one optical fiber, the method for detecting target tissue comprising the steps of detecting fluorescence emitted from the target tissue during a surgical procedure by at least one optical fiber of the working instrument using the optical system, the step of detecting fluorescence comprising the steps of illuminating the tissue with blue light from the excitation source using the at least one optical fiber, collecting ambient light and fluorescence using the at least one optical fiber, generating a fluorescence signal based on the fluorescence emitted from the target tissue with the ambient light removed, determining the presence of target tissue based on the detected fluorescence, and activating an indicator of the working instrument in response to detection of the target tissue.

[0207] Article 73 - An optical probe system for determining whether brain tissue of a patient is tumorous. The optical probe system includes a sample element including an optical fiber configured to transmit fluorescence emitted by the 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 the tumor tissue. The optical probe system includes an optical instrument coupled to the optical fiber, the optical instrument configured to convert the fluorescence emitted by the brain tissue and transmitted by the optical fiber into an electrical signal, and a controller coupled to the indicator and the optical instrument, the controller configured to determine that the brain tissue is tumorous based on the electrical signal and to activate the indicator based on the determination that the brain tissue is tumorous.

[0208] Clause 74 - A neurosurgical method for distinguishing brain tumor tissue from healthy brain tissue, comprising the steps of: providing an optical probe including a single optical fiber having a distal end; positioning the optical probe so that the optical probe is in contact with target tissue; emitting light of a wavelength of 400 to 410 nm from an excitation source through the single optical fiber while the optical probe is in contact with the tissue to induce fluorescent emission in the target tissue through the single optical fiber; receiving the light emitted from the target tissue with the single optical fiber while the optical probe is in contact with the tissue; and controlling an indicator based on the received light.

[0209] Clause 75 - The method of clause 74, wherein the indicator is attached to the optical probe.

[0210] Clause 76 - The method of Clause 74, wherein the optical probe defines a lumen, and the method further comprises the step of connecting the optical probe to a suction source.

[0211] Clause 77 - A neurosurgical method for detecting tumor tissue under ambient light conditions during a surgical procedure in an operating room, comprising the steps of receiving a light source from a handheld optical probe, analyzing the light source using a spectrometer to output a spectrometer signal, calculating a second signal by removing the effects of ambient light from the spectrometer signal, identifying a single band associated with PPIX based on the second signal, and controlling an indicator based on the intensity of the single band.

[0212] Clause 78 - A neurosurgical method for detecting tumor tissue under ambient light conditions during a surgical procedure in an operating room, comprising the steps of receiving a light source from a handheld optical probe, analyzing the light source using a spectrometer to output a spectrometer signal, fitting a plurality of bands to the spectrometer, selecting one fitting band from the plurality of fitted bands based on an average value criterion, determining an intensity of the selected fitting band, and controlling an indicator based on the intensity of the selected fitting band.

[0213] Article 79 - A neurosurgical system for examining brain tissue of a patient for tumor tissue, comprising a neurosurgical instrument, the neurosurgical instrument including a tubular member defining a lumen, an optical fiber coupled to the tubular member, and a console, the console including an excitation source configured to emit excitation light through the optical fiber, the excitation light having a wavelength that induces fluorescence in the tumor tissue, a spectrometer configured to output a spectrometer signal, an indicator, and a controller, the controller configured to identify a band corresponding to the emission of a single fluorophore based on the spectrometer signal, determine an intensity of the identified band, and control the indicator based on the intensity of the identified band.

[0214] Clause 80 - A neurosurgical system for examining a patient's brain tissue for tumor tissue, comprising: a handheld optical probe configured to be positioned adjacent to the tissue of interest; and a console, the console including an excitation source configured to emit excitation light through an optical fiber, the excitation light having a wavelength that induces fluorescence in the tumor tissue; a spectrometer configured to output a spectrometer signal; an indicator; and a controller, the controller configured to identify a band corresponding to PPIX based on the spectrometer signal, determine an intensity of the identified band, and control the indicator based on the intensity of the identified band.

[0215] Clause 81 - The system of clause 80, wherein the controller is further configured to identify a second band corresponding to PPIX based on the spectrometer, determine an intensity of the identified second band, and control the indicator based on the intensity of the identified second band.

[0216] Clause 82 - A neurosurgical instrument assembly for differentiating brain tumor tissue from healthy brain tissue, comprising a neurosurgical instrument comprising a tubular member defining a lumen and having an outer surface, a single optical fiber coupled to the tubular member, the single optical fiber adapted to transmit excitation light to the target tissue and receive light emitted from the target tissue, and a light indicator coupled to the tubular member, the light indicator configured to emit light of a visible wavelength, the assembly further comprising: a connector line extending from the neurosurgical instrument; and a connector coupled to the connector line, the connector including a single optical fiber coupling and an electrical terminal, configured to connect to a surgical console including a light source and a controller.

[0217] Clause 83 - The instrument assembly of clause 82, wherein the electrical terminal is coupled to an optical indicator, and the single optical fiber coupling is in optical communication with a distal end of the single optical fiber.

[0218] Clause 84 - The instrument assembly of clause 82, further comprising a suction line, the suction line being coupled to the port of the tubular member, the suction line being connected to the connector line.

[0219] Clause 85 - A surgical console comprising: a connection port for receiving a connector including an optical fiber; a spectrometer; a light emitter; and an optical block for routing light, the optical block defining a first portion extending from the connection port to a first junction, a light emitter portion extending from the first junction to the light emitter, and a detector portion extending from the first junction to the spectrometer.

[0220] Clause 86 - The surgical console of clause 85, further comprising a fiber lens disposed in the first portion.

[0221] Clause 87 - The surgical console of clause 86, further comprising a spectrometer lens disposed in the detector portion.

[0222] Clause 88 - The surgical console of clause 85, further comprising a light emitter lens disposed in the light emitting portion.

[0223] Clause 89 - The surgical console of clause 85, further comprising an adjustment mechanism for adjusting the position of the spectrometer.

[0224] Clause 90 - The surgical console of clause 85, further comprising an adjustment mechanism for adjusting the position of the light emitter.

[0225] Clause 91 - The surgical console of clause 89, wherein the adjustment mechanism includes an adjustment screw and a locking screw.

[0226] Clause 92 - The surgical console of clause 89, wherein the adjustment mechanism includes a first adjustment member for adjusting the position of the spectrometer in a first degree of freedom and a second adjustment member for adjusting it in a second degree of freedom.

[0227] Clause 93 - The surgical console of clause 88, wherein the illuminator lens has a focal length different from the focal length of at least one of the spectrometer lens and the fiber lens.

[0228] Clause 94 - The surgical console of clause 88, wherein the focal length of the illuminator lens has a focal length longer than the focal length of the spectrometer lens.

[0229] Clause 95 - The surgical console of clause 88, wherein the focal length of the illuminator lens is greater than the focal length of the fiber lens.

[0230] Clause 96 - The surgical console of clause 88, wherein the focal length of the illuminator lens is greater than the focal length of both the spectrometer lens and the fiber lens.

[0231] Clause 97 - The surgical console of clause 88, further comprising a C-shaped member disposed within the connection port.

[0232] Clause 98 - A system for distinguishing tissue from tumor tissue, comprising: a handheld optical probe configured to be positioned adjacent to tissue of interest; a spectrometer configured to receive collected light from the handheld optical probe and output a corresponding spectrometer signal; a controller in communication with the spectrometer; and an indicator in communication with the controller, wherein the controller is configured to: obtain a first digital signal based on the spectrometer signal; calculate a second signal by removing the effect of ambient light from the spectrometer signal; fit a plurality of bands to the second signal; select one fitting band from the plurality of fitted bands based on an average value criterion; determine an intensity of the selected fitting band; and control the indicator based on the intensity of the selected fitting band.

[0233] Article 99 - An instrument assembly for distinguishing tumor tissue from healthy tissue, comprising an instrument comprising: a tubular member defining a lumen and having an outer surface; a first optical fiber coupled to the tubular member, the first optical fiber configured to transmit excitation light to brain tissue of a target and to receive light emitted from the brain tissue of the target; a second optical fiber coupled to the tubular member and configured to transmit light of a visible wavelength; a connector line extending from the instrument, the connector line defining a first optical path in communication with the first optical fiber and a second optical path in communication with the second optical fiber; and a connector coupled to the connector line, the connector including a first optical fiber coupling for connecting the first optical path to a surgical console and a second fiber coupling for connecting the second optical path to the surgical console.

[0234] Clause 100 - An instrument assembly for distinguishing tumor tissue from healthy tissue, comprising: a handheld probe instrument comprising: a tubular member defining an outer surface; a first optical fiber coupled to the member, the first optical fiber adapted to transmit excitation light to a tissue of interest and receive light emitted from the tissue of interest; and a second optical fiber coupled to the tubular member and configured to transmit light of a visible wavelength; a connector line extending from the handheld probe instrument, the connector line defining a first optical path in communication with the first optical fiber and a second optical path in communication with the second optical fiber; and a connector coupled to the connector line, the connector including a first optical fiber coupling for connecting the first optical path to a surgical console and a second optical fiber coupling for connecting the second optical path to the surgical console.

[0235] Clause 101 - An ultrasonic surgical system comprising: an ultrasonic handpiece assembly configured to remove brain tissue; a sample element coupled to the ultrasonic handpiece assembly and including at least one fiber configured to collect fluorescence emitted from the brain tissue; an indicator fiber coupled to the ultrasonic handpiece assembly and configured to selectively transmit light; and a controller, wherein the controller is configured to detect a type of brain tissue based on the fluorescence, cause the optical element to provide light to the indicator fiber based on the detected type of brain tissue, and control the ultrasonic handpiece assembly based on the detected type of brain tissue.

[0236] Clause 102 - A surgical system comprising: a surgical instrument configured to remove brain tissue; a sample element coupled to the surgical instrument and including at least one fiber configured to collect fluorescence emitted from the brain tissue; an indicator fiber coupled to the ultrasound handpiece assembly and configured to selectively transmit light; and a controller, wherein the controller is configured to detect a type of brain tissue based on the fluorescence, cause the optical element to provide light to the indicator fiber based on the detected type of brain tissue, and control the surgical instrument based on the detected type of brain tissue.

[0237] Clause 103 - A surgical suction system comprising: a suction instrument that applies suction to brain tissue; a sample element that includes at least one optical fiber coupled to the suction instrument and configured to collect fluorescence emitted from the brain tissue; an indicator fiber coupled to the suction instrument; and a controller, the controller configured to detect a type of brain tissue based on the fluorescence and to control a light source coupled to the indicator fiber based on the type of brain tissue detected.

[0238] Clause 104 - A method for detecting target tissue under ambient light conditions in an operating room during a surgical procedure, comprising the steps of: positioning an optical fiber within a sterile field containing brain or other type of tissue illuminated by the ambient light; collecting fluorescence emitted from the tissue using the optical fiber; detecting the target tissue, the brain tissue or other type of tissue, based on the fluorescence emitted from the brain tissue using a controller coupled to the optical fiber; and controlling a light source coupled to an indicator fiber positioned within the sterile field to generate a visual alert in response to detection of the target tissue.

[0239] Clause 105 - A method for detecting target tissue under ambient light conditions in an operating room using a surgical system, the surgical system comprising a working instrument including at least one optical fiber, an indicator coupled to the working instrument, and an excitation source coupled to the at least one optical fiber, the method for detecting the target tissue comprising the steps of: positioning the working instrument in a sterile field containing tissue illuminated by ambient light; detecting fluorescence emitted from the target tissue during the surgical procedure using at least one optical fiber of the working instrument with an optical system including: illuminating the tissue with blue light from the excitation source using the at least one optical fiber; collecting the ambient light and the fluorescence using the at least one optical fiber; and generating a fluorescence signal based on the fluorescence emitted from the target tissue in the absence of ambient light; determining that target tissue is present based on the detected fluorescence; and controlling a light source coupled to the indicator fiber of the working instrument in response to the detection of the target tissue.

[0240] Clause 106 - A method for detecting and removing target tissue under ambient light conditions in an operating room 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 fiber, an optical system, and an excitation source coupled to the at least one optical fiber, the method for detecting target tissue comprising 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 causing an indicator fiber of the attachment to emit a colored light in response to detection of target tissue while at least one of the first working instruments and at least one of the second working instruments are in a sterile field; viewing the indicator fiber of the attachment while at least one of the first working instruments and at least one of the second working instruments are in the sterile field; performing a first surgical operation at the surgical site while the first working instrument is in a first hand of a surgeon; and performing a second surgical operation at the surgical site while the second working instrument is in a second hand of the surgeon in response to emission of the indicator fiber while the first working instrument is held in the first hand.

[0241] Clause 107 - A method for detecting target tissue under ambient light conditions in an operating room using a surgical system, the surgical system comprising a working instrument including at least one optical fiber and an indicator fiber, an optical system coupled to the working instrument, and an excitation source coupled to the at least one optical fiber, the method for detecting the target tissue comprising the steps of: detecting, using the optical system, fluorescence emitted from the target tissue during a surgical procedure with at least one optical fiber of the working instrument, the steps including: illuminating the tissue with blue light from the excitation source with the at least one optical fiber; collecting, using the at least one optical fiber, ambient light and fluorescence; and generating a fluorescence signal based on the fluorescence emitted from the target tissue in the absence of ambient light; determining that the target tissue is present based on the detected fluorescence; and controlling a light source coupled to the indicator fiber of the working instrument in response to the detection of the target tissue.

[0242] Clause 108 - A neurosurgical method for distinguishing brain tumor tissue from healthy brain tissue, comprising the steps of: providing an optical probe including a first optical fiber having a distal end; positioning the optical probe so that the optical probe is in contact with a target tissue; emitting light having a wavelength of 400-410 nm from an excitation source through the optical fiber while the optical probe is in contact with the tissue to induce fluorescent emission in the target tissue through the optical fiber; receiving the light emitted from the target tissue using the optical fiber while the optical probe is in contact with the tissue; and controlling an indicator based on the received light, wherein only one optical fiber receives the light emitted from the tissue and emits light from the excitation source.

[0243] Clause 109 - A method for detecting tumor tissue under ambient light conditions during a surgical procedure in an operating room, comprising the steps of receiving a light source from a handheld optical probe, analyzing the light source using a spectrometer to output a spectrometer signal, calculating a second signal by removing the effects of ambient light from the spectrometer signal, identifying a single band associated with PPIX based on the second signal, and controlling a light source coupled to an indicator fiber based on the intensity of the single band.

[0244] Clause 110 - A method for detecting tumor tissue under ambient light conditions during a surgical procedure in an operating room, comprising the steps of receiving collected light from a handheld optical probe; analyzing the light source using a spectrometer to output a spectrometer signal; fitting a plurality of bands to the spectrometer; selecting a fitting band from the plurality of fitted bands based on an average value criterion; determining an intensity of the selected fitting band; and controlling a light source coupled to an indicator fiber based on the intensity of the selected fitting band or controlling an indicator based on the intensity of the selected fitting band.

[0245] Clause 111 - A neurosurgical system for examining tissue of a patient for tumor tissue, comprising: an instrument including a tubular member defining a lumen, an optical fiber coupled to the tubular member, and a console including an excitation source configured to emit excitation light through the optical fiber having a wavelength that induces fluorescence in the tumor tissue, a spectrometer configured to output a spectrometer signal, an indicator fiber coupled to the instrument, and a controller configured to identify bands corresponding to emissions of a single fluorophore based on the spectrometer signal, determine an intensity of the identified band, and control a light source coupled to the indicator fiber based on the intensity of the identified band.

[0246] Clause 112 - A method for detecting tumor tissue under ambient light conditions during a surgical procedure in an operating room, comprising the steps of receiving a light source from a handheld optical probe, analyzing the light source using a spectrometer to output a spectrometer signal, calculating a second signal by removing the effect of ambient light from the spectrometer signal, identifying a single band associated with PPIX based on the second signal, and controlling light coupled into an optical fiber based on the intensity of the single band.

[0247] Clause 113 - A system for examining tissue of a patient for tumor tissue, comprising: an instrument; an optical fiber coupled to the instrument; and a console, the console including an excitation source configured to emit excitation light having a wavelength that induces fluorescence in the tumor tissue via the optical fiber; a spectrometer configured to output a spectrometer signal; an indicator fiber coupled to the instrument; and a controller, the controller configured to identify a band corresponding to the emission of a single fluorophore based on the spectrometer signal, determine an intensity of the identified band, and control a light source coupled to the indicator fiber based on the intensity of the identified band.

[0248] Clause 114 - An instrument assembly for distinguishing tumor tissue from healthy tissue, comprising a neurosurgical instrument comprising: a tubular member defining a lumen and having an outer surface; an optical fiber coupled to the tubular member, the optical fiber adapted to transmit excitation light to the target tissue and receive light emitted from the target tissue; and an indicator fiber coupled to the tubular member, the indicator fiber coupled to a light source configured to emit light of a visible wavelength; the assembly further comprising: a connector line extending from the neurosurgical instrument; and a connector coupled to the connector line, the connector including two optical fiber couplings and configured to connect to a surgical console including the indicator light source and the light emission source and a controller.

[0249] The foregoing description is merely exemplary in nature and is in no way intended to limit the disclosure, its application, or uses. The broad teachings of the present disclosure can be embodied in a variety of forms. Accordingly, while the present disclosure includes specific examples, the true scope of the disclosure should not be so limited, as other modifications will become apparent upon review of the drawings, the specification, and the following claims. It should be understood that one or more steps within a method can be performed in a different order (or simultaneously) without altering the principles of the present disclosure. Furthermore, although each example is described above as having specific features, any one or more of these features described with respect to any example of the present disclosure may be implemented in and / or combined with any feature of any of the other examples, even if the combination is not explicitly described. In other words, the described examples are not mutually exclusive, and substitution of one or more examples for one another is also within the scope of the present disclosure.

[0250] Spatial and functional relationships between elements (e.g., between controllers, between circuit elements, between semiconductor layers, etc.) are described using various terms including "connected," "engaged," "coupled," "adjacent," "next to," "on," "above," "below," and "disposed," unless expressly described as "direct," and where a relationship between a first element and a second element is described in the above disclosure, the relationship can be a direct relationship where no other intervening elements exist between the first element and the second element, but it can also be an indirect relationship where one or more intervening elements exist (spatially or functionally) between the first element and the second element.

[0251] As used herein, the phrase "at least one of A, B, and C" should be interpreted to mean a logical non-exclusive OR (A OR B OR C), and not to mean "at least one of A, at least one of B, and at least one of C." The term subset does not necessarily require a proper subset. In other words, a first subset of a first set may be coextensive with (equal to) the first set.

[0252] In a diagram, the direction of an arrow, as indicated by the arrowhead, generally indicates the flow of information (such as data or instructions) that is important to the diagram. For example, an arrow may point from element A to element B if elements A and B exchange various information, but the information conveyed from element A to element B is relevant to the diagram. This one-way arrow does not imply that other information cannot be conveyed from element B to element A. Furthermore, for information sent from element A to element B, element B can send a request for or acknowledgement of the information to element A.

[0253] In this application, including in the definitions below, the term "controller" or "module" may be substituted for the term "circuitry." The term "controller" may refer to, be a part of, or include an application specific integrated circuit (ASIC), a programmable system on a chip (PSoC), digital, analog, or mixed analog / digital discrete circuitry, a digital, analog, or mixed analog / digital integrated circuit, a combinational logic circuit, a field programmable gate array (FPGA), a processor circuit (shared, dedicated, or group) that executes code, a memory circuit (shared, dedicated, or group) that stores code executed by the processor circuitry, other suitable hardware components that provide the described functionality, or a system on a chip, or any combination of some or all of the above.

[0254] The controller may include one or more interface circuits with one or more transceivers. In some examples, the interface circuit may implement a wired or wireless interface to connect to a local area network (LAN) or a wireless personal area network (WPAN). Examples of LANs include the Institute of Electrical and Electronics Engineers (IEEE) Standard 802.11-2016 (also known as the WIFI wireless networking standard) and IEEE Standard 802.3-2015 (also known as the ETHERNET wired networking standard). Examples of WPANs include the Bluetooth wireless networking standard from the Bluetooth Special Interest Group and IEEE Standard 802.15.4.

[0255] Controllers can communicate with other controllers using interface circuits. While this disclosure illustrates controllers logically communicating directly with other controllers, in various implementations, the controllers can actually communicate through a communication system. The communication system may include physical and / or virtual networking equipment such as hubs, switches, routers, gateways, transceivers, etc. 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 leased lines using technologies such as multiprotocol label switching (MPLS) or virtual private networks (VPNs).

[0256] In various implementations, the functionality of a controller may 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, the functionality of a controller may be split between a server (also known as a remote or cloud) controller and a client (or user) controller.

[0257] Some or all of the hardware characteristics of the controller can be defined using a hardware description language such as IEEE Standard 1364-2005 (commonly referred to as "Verilog") or IEEE Standard 1076-2008 (commonly referred to as "VHDL"). The hardware description language can be used to fabricate and / or program hardware circuits. In some implementations, some or all of the functionality of the controller can be defined by a language such as IEEE 1666-2005 (commonly referred to as "SystemC"), which encompasses both code and hardware descriptions, as described below.

[0258] As used above, the term code 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 code from multiple controllers. The term group processor circuit includes a processor circuit that executes some or all code from one or more controllers in combination with additional processor circuits. References to multiple processor circuits include multiple processor circuits on separate dies, multiple processor circuits on a single die, multiple cores of a single processor circuit, multiple threads of a single processor circuit, or combinations of the above. The term shared memory circuit includes a single memory circuit that stores some or all code from multiple controllers. The term group memory circuit encompasses a memory circuit that stores some or all code from one or more controllers in combination with additional memory.

[0259] The term memory circuit is a subset of the term computer-readable medium. As used herein, the term computer-readable medium does not encompass transitory electrical or electromagnetic signals propagating in a medium (such as a carrier wave). Thus, the term computer-readable medium may be considered tangible and non-transitory. Non-limiting examples of non-transitory computer-readable media are non-volatile memory circuits (such as flash memory circuits, erasable programmable read-only memory circuits, or mask read-only memory circuits), volatile memory circuits (e.g., static random access memory circuits or dynamic random access memory circuits), magnetic storage media (such as analog or digital magnetic tape, hard disk drives), and optical storage media (such as CDs, DVDs, or Blue-ray discs).

[0260] The apparatus and methods described in this application may be implemented partially or completely by a special-purpose computer created by configuring a general-purpose computer to perform one or more specific functions embodied in a computer program. The functional blocks and flowchart elements described above may function as software specifications that can be converted into a computer program by the routine work of a skilled engineer or programmer.

[0261] A computer program includes processor-executable instructions stored on at least one non-transitory computer-readable medium. A computer program may also include or rely on stored data. A computer program may include a basic input / output system (BIOS) that interacts with hardware in a special-purpose computer, device drivers that interact with specific devices in a special-purpose computer, one or more operating systems, user applications, background services, and background applications.

[0262] A computer program may include (i) descriptive text to be parsed, such as HTML (Hypertext Markup Language), XML (Extensible Markup Language), or JSON (JavaScript Object Notation); (ii) assembly code; (iii) object code generated from source code by a compiler; (iv) source code executed by an interpreter; (v) source code compiled and executed by a just-in-time compiler; etc. By way of example only, the source code may be written using syntax from languages ​​including C, C++, C#, ObjectiveC, Swift, Haskell, Go, SQL, R, Lisp, Java®, Fortran, Perl, Pascal, Curl, OCaml, JavaScript®, HTML5 (Hypertext Markup Language Fifth Edition), Ada, ASP (Active Server Pages), PHP (PHP: Hypertext Preprocessor), Scala, Eiffel, Smalltalk, Erlang, Ruby, Flash®, Visual Basic®, Lua, MATLAB®, SIMULINK®, and Python®.

Claims

1. 1. A neurosurgical system for distinguishing healthy brain tissue from tumorous brain tissue, comprising: a handheld optical probe configured to be positioned adjacent to the tissue of interest; a spectrometer configured to receive collected light from the handheld optical probe and output a corresponding spectrometer signal; a controller in communication with the spectrometer; an indicator in communication with the controller; Equipped with The controller obtaining a first digital signal based on the spectrometer signal; calculating a second signal by removing the effect of ambient light from the spectrometer signal; fitting a plurality of bands to the second signal; selecting a fitting band from the plurality of fitted bands based on an average value criterion; determining the intensity of the selected one fitting band; controlling the indicator based on the intensity of the selected one fitting band; A neurosurgery system configured to:

2. The neurosurgical system of claim 1 , wherein the step of fitting the plurality of bands to the second signal is further defined as fitting a plurality of distribution curves to the second signal.

3. The neurosurgical system of claim 2 , wherein the plurality of distribution curves is further defined as a plurality of Gaussian distribution curves, a plurality of Lorentzian distribution curves, or a combination thereof.

4. The neurosurgical system of claim 1 , wherein the controller is further configured to select a fitting band exhibiting a mean value criterion of 635 nm.

5. The neurosurgical system of claim 4 , wherein the controller is further configured to select the one fitted band from the plurality of fitted bands based on the mean value criterion and the standard deviation criterion.

6. The neurosurgical system of claim 1 , wherein the controller is further configured to select the one fitting band from the plurality of fitted bands based on a standard deviation criterion value.

7. The neurosurgical system of claim 1 , wherein the controller is further configured to control the indicator based on the intensity of the selected one fitting band and a predetermined intensity threshold.

8. 6. The neurosurgical system of claim 5, wherein the controller is further configured to calculate an amplitude offset based on an amplitude of the second signal and the selected one fitting band, and to control the indicator based on the amplitude offset and a predetermined amplitude offset threshold.

9. The neurosurgical system of claim 8 , wherein the controller is further configured to calculate the amplitude offset based on a center of the selected one fitting band.

10. 2. The neurosurgical system of claim 1, wherein the controller is further configured to calculate the second signal by fitting a baseline polynomial curve to the spectrometer signal and to subtract the baseline polynomial curve from the spectrometer signal to remove the ambient light artifact to result in the second signal.

11. The neurosurgical system of claim 10 , wherein the system is further configured to fit the baseline polynomial curve to a region of the spectrometer signal.

12. 1. A neurosurgical instrument assembly for distinguishing brain tumor tissue from healthy brain tissue, comprising: a neurosurgical instrument; a tubular member defining a lumen and having an outer surface; a first optical fiber coupled to the tubular member, the first optical fiber adapted to transmit excitation light to brain tissue of the subject and to receive light emitted from the brain tissue of the subject; a second optical fiber coupled to the tubular member and configured to transmit light in visible wavelengths; a connector line extending from the neurosurgical instrument, the connector line defining a first optical path in communication with the first optical fiber and a second optical path in communication with the second optical fiber; a connector coupled to the connector line, the connector including a first fiber optic coupling for connecting the first optical path to a surgical console and a second fiber optic coupling for connecting the second optical path to the surgical console; A neurosurgical instrument assembly comprising:

13. 13. The neurosurgical instrument assembly of claim 12, wherein the outer surface of the tubular member defines a first channel, the first optical fiber is at least partially disposed within the first channel, and the neurosurgical instrument further includes a sleeve surrounding the first optical fiber and a portion of the tubular member.

14. 14. The neurosurgical instrument assembly of claim 13, wherein the second optical fiber is at least partially disposed within the first channel, and the sleeve surrounds the first optical fiber, the second optical fiber, and a portion of the tubular member.

15. 14. The neurosurgical instrument assembly of claim 13, wherein the outer surface of the tubular member defines a second channel separate from the first channel, and the second optical fiber is at least partially disposed within the second channel.

16. The neurosurgical instrument assembly of claim 12 , wherein the neurosurgical instrument assembly is devoid of electrical contacts.

17. The neurosurgical instrument assembly according to claim 12, wherein the first optical fiber has a diameter of less than 500 μm.

18. 13. The neurosurgical instrument assembly of claim 12, wherein a distal end of the first optical fiber is positioned near a distal end of the tubular member and a distal end of the second optical fiber is positioned near the distal end of the first optical fiber.

19. The neurosurgical instrument assembly of claim 18 , wherein the first optical fiber and the second optical fiber are positioned adjacent to one another.

20. The neurosurgical instrument assembly of claim 12 , wherein a distal end of the first optical fiber is aligned with a distal end of the tubular member.

21. 13. The neurosurgical instrument assembly of claim 12, wherein a distal end of the first optical fiber is disposed on a first side of the tubular member and a distal end of the second optical fiber is disposed on a second side of the tubular member opposite the first side.

22. 13. The neurosurgical instrument assembly of claim 12, wherein the tubular member is curved in a first direction along its length, a distal end of the first optical fiber disposed on a side of the tubular member in the direction of curvature, and a distal end of the second optical fiber disposed on a side of the tubular member opposite the direction of curvature.

23. The neurosurgical instrument assembly of claim 12, further comprising a distal tube sleeve disposed on the outer surface of the tubular member and at a distal end of the tubular member, the distal tube sleeve comprising an at least partially transparent material.

24. 24. The neurosurgical instrument assembly of claim 23, further comprising a proximal tube sleeve disposed on a portion of the outer surface of the tubular member proximal to the distal tube sleeve, the proximal tube sleeve comprising an opaque material.

25. The neurosurgical instrument assembly of claim 12 , wherein a portion of the second optical fiber includes a textured surface for diffusing transmitted light.

26. 26. The neurosurgical instrument assembly of claim 25, wherein an outer surface of the second optical fiber is deformed by a crimping process to form the textured surface.

27. 1. A neurosurgical system for distinguishing brain tumor tissue from healthy brain tissue, comprising: a handheld optical probe configured to be positioned adjacent to the tissue of interest; a spectrometer configured to receive collected light from the handheld optical probe and output a corresponding spectrometer signal; a controller in communication with the spectrometer; Equipped with The controller calculating a second signal by removing the effect of ambient light from the spectrometer signal; identifying a single band associated with PPIX based on the second signal; controlling an indicator based on the intensity of the single band; A neurosurgery system configured to:

28. 28. The neurosurgical system of claim 27, wherein the indicator comprises a visual indicator configured to emit light when the intensity of the single band exceeds a predetermined threshold.

29. 30. The neurosurgical system of claim 28, wherein the indicator further comprises an audible indicator configured to emit a sound when the intensity of the single band exceeds a predetermined threshold.

30. 30. The neurosurgical system of claim 28, wherein the indicator is further configured to emit light at a brightness corresponding to the intensity of the single band.

31. 28. The neurosurgical system of claim 27, wherein the indicator comprises an audible indicator configured to emit a sound when the intensity of the single band exceeds a predetermined threshold.

32. The neurosurgical system of claim 27 , wherein the indicator is coupled to the handheld optical probe.

33. 33. The neurosurgical system of claim 32, wherein the indicator is positioned adjacent to a light collecting portion of the handheld optical probe.

34. 1. A method of forming a handheld surgical probe including an optical fiber for providing instructions to a user, comprising: Providing a suction apparatus body defining a lumen and having an outer surface; positioning a mandrel adjacent to the suction instrument body; positioning a first heat shrink tube to partially surround the suction apparatus body and the mandrel; applying heat to the first heat shrink tube to form a first deformed heat shrink tube surrounding a portion of the suction instrument body; removing the mandrel adjacent the suction instrument body; routing an optical fiber between the suction instrument body and an inner diameter of the first modified heat shrink tubing; positioning a second modified heat shrink tube over the distal end of the suction device body so as to partially surround a portion of the suction device body and the optical fiber; A method comprising:

35. 35. The method of claim 34, further comprising preforming the second heat shrink tube to form the second deformed heat shrink tube before positioning the second heat shrink tube over the distal end of the suction instrument body.

36. 36. The method of claim 35, wherein the preforming step includes applying heat to the second heat shrink tubing while the second heat shrink tubing is positioned around a second mandrel having a shape that matches the shape of the distal end of the suction instrument body.

37. 35. The method of claim 34, wherein the second deformed heat shrink tubing is formed from a transparent material.

38. 35. The method of claim 34, wherein the first heat shrink tubing is formed from an opaque material.

39. 35. The method of claim 34, wherein the optical fiber has a melting point lower than the melting points of the first and second heat shrink tubes.

40. 35. The method of claim 34, further comprising the step of securing the second deformed heat shrink tubing to the suction instrument body using an adhesive.

41. 41. The method of claim 40, wherein the adhesive is UV curable.

42. 35. The method of claim 34, further comprising the step of positioning the optical fiber within a groove formed in the outer diameter of the suction instrument body.

43. 43. The method of claim 42, wherein the step of positioning the second deformed heat shrink tube comprises positioning the second deformed heat shrink tube such that the second deformed heat shrink tube partially surrounds the groove.

44. 39. The method of claim 38, wherein the melting point of the optical fiber is at least 50°C lower than the melting point of the first heat shrink tubing.

45. 35. The method of claim 34, wherein the thickness of the second deformed heat shrink tubing is less than the thickness of the first deformed heat shrink tubing.

46. 46. ​​The method of claim 45, wherein the thickness of the second deformed heat shrink tubing is at least 75% less than the thickness of the first deformed heat shrink tubing.

47. 35. The method of claim 34, wherein the thickness of the second deformed heat shrink tubing is less than 2% of the outer diameter of the distal end of the suction instrument body.

Images