Endoscopically- associated optical sensor verification
The method and system for verifying endoscopic optical sensors by comparing measured spectra to reference spectra address the issue of sensor inaccuracies, ensuring accurate and efficient data collection during medical procedures.
Patent Information
- Authority / Receiving Office
- WO · WO
- Patent Type
- Applications
- Current Assignee / Owner
- Filing Date
- 2025-09-11
- Publication Date
- 2026-03-26
AI Technical Summary
Existing endoscopic optical sensors used in medical procedures may not be adequately verified for proper functioning, leading to potential inaccuracies in data collection and inefficiencies in medical procedures.
A method and system for verifying the operation of endoscopically-associated optical sensors by activating a light source to emit a specified optical signal, measuring the spectrum, and comparing it to a reference spectrum to ensure the sensor operates within specified tolerances, which can be performed automatically or partially automatically.
Ensures accurate and efficient operation of optical sensors during medical procedures by automatically verifying their functionality, reducing the risk of inaccurate data collection and improving procedural precision and efficiency.
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Figure US2025045929_26032026_PF_FP_ABST
Abstract
Description
Docket No. 5409.875WO1ENDOSCOPICALLY- ASSOCIATED OPTICAL SENSOR VERIFICATIONPRIORITY CLAIM
[0001] This application claims the benefit of priority to U.S. Provisional Patent Application Serial No. 63 / 696,448, filed September 19, 2024, the contents of which are incorporated herein by reference.TECHNICAL FIELD
[0002] The present disclosure relates to sensor verification, and more particularly, but not by way of limitation, to verification of an endoscopically-associated optical sensor, such as can be used in an endoscopic medical procedure.BACKGROUND
[0003] Laser or ultrasonic systems may be used for delivering therapeutic laser or ultrasonic energy to various target treatment areas such as may include soft or hard tissue. Examples of laser therapy may include ablation, coagulation, vaporization, fragmentation, etc. In lithotripsy applications, laser therapy may be used to break down calculi structures in one or more of the kidney, gallbladder, ureter, or other stone-forming regions, or to ablate large calculi into smaller fragments.
[0004] Endoscopes may be used to provide access to an internal location of a patient such that a physician may be provided with visual access. An endoscope may be inserted into a patient's body and may deliver a therapeutic beam to a target. An endoscope may include a working channel through which the operator can perform suction or pass instruments, such as may include a laser fiber, a stone-removal basket, brushes, biopsy needles, or forceps, or perform minimally invasive surgery to remove unwanted tissue or other objects from the patient. An endoscope may also include an irrigation system, such as may provide an irrigation flow to the region surrounding the endoscope insertion tip.
[0005] Modem systems can use optical sensors to measure electromagnetic waves. Optical sensors may generate optical data corresponding to at least a portion of the measured electromagnetic waves. Examples of such modem systems include light intensity sensors, cameras, and spectrometers. The collected optical data may be processed to determine a characteristic of the source of the optical data.SUMMARYDocket No. 5409.875WO1
[0006] In an example, a method for verifying an operation of an endoscopically- associated optical sensor can include activating a light source to emit a first optical signal which can have a specified spectrum. The method can also include measuring, using the optical sensor, a first spectrum which can correspond to the first optical signal. The method can also include comparing the first spectrum to a reference spectrum such as to determine whether the optical sensor is operating within a specified tolerance.
[0007] In an example, a medical device system for verifying an operation of an endoscopically associated optical sensor during an endoscopic medical procedure can include the optical sensor, which can be configured to measure a first spectrum which can correspond to a light source which can have a specified spectrum. The medical device system can also include processor circuitry, which can be configured to retrieve a reference spectrum associated with the light source and can be configured to compare the first spectrum to the retrieved reference spectrum such as to determine whether the optical sensor is operating within a specified tolerance.
[0008] In an example, a medical device system for verifying an operation of an endoscopically-associated optical sensor can include a processor. The medical device system can also include a memory storing instructions that, when executed by the processor, can configure the medical device system to activate a light source to emit a first optical signal which can have a specified spectrum. Measure, such as using the optical sensor, a first spectrum which can correspond to the first optical signal. And compare the first spectrum to a reference spectrum such as to determine whether the optical sensor is operating within a specified tolerance.BRIEF DESCRIPTION OF THE DRAWINGS
[0009] In the drawings, which may not be drawn to scale, like numerals may describe substantially similar components throughout one or more of the views. Like numerals having different letter suffixes may represent different instances of substantially similar components. The drawings illustrate generally, by way of example but not by way of limitation.
[0010] FIG. 1 illustrates an example of locations for placement of optical components within a laser system.
[0011] FIG. 2 illustrates an example of portions of a laser system.
[0012] FIG. 3 illustrates an example of portions of the laser system of FIG. 2 without a laser fiber connected and with the laser dust door closed.Docket No. 5409.875WO1
[0013] FIG. 4 illustrates a schematic diagram of an example of portions of an endoscopy system.
[0014] FIG. 5 is a schematic diagram of an example of portions of the endoscopy system of FIG. 4 including an example of portions of the imaging and control system and the endoscope.
[0015] FIG. 6 is a drawing of an example of portions of an endoscopy system for verifying an endoscopically-associated optical sensor and portions of an environment in which the endoscopy system can be used.
[0016] FIG. 7 is a diagram showing an example of a method of operating a system for verifying an optical sensor.
[0017] FIG. 8 is a diagram showing an example of a method of operating a system for verifying an optical sensor.
[0018] FIG. 9 is a diagram showing an example of a method of operating a system for verifying an optical sensor.
[0019] FIG. 10 is a diagram showing an example of a method of operating a system for verifying an optical sensor.
[0020] FIG. 11 is a diagram showing an example of a method of operating a system for verifying an optical sensor.
[0021] FIG. 12A is a graph showing an example of a first spectrum and a second spectrum.
[0022] FIG. 12B is a graph showing an example of an adjusted spectrum determined using the first spectrum and the second spectrum of FIG. 12A and a reference spectrum.
[0023] FIG. 13 is a graph showing an example of collected background spectra.
[0024] FIG. 14 is a graph showing an example of a spectra collected with the laser aiming beam on.
[0025] FIG. 15 is a graph showing an example of a collected background spectra of and a collected spectra with the laser aiming beam on spectra on.
[0026] FIG. 16 is a schematic diagram of a computer-based clinical decision support system (CDSS).
[0027] FIG. 17 is a block diagram illustrating an example of a machine upon which one or more examples may be implemented.DETAILED DESCRIPTIONDocket No. 5409.875WO1
[0028] A medical device system, such as an endoscopy system, can use one or more optical sensors. The one or more optical sensors can be used to provide information about an ongoing procedure, adjust a function or process of a medical device system, or provide information to a clinician. The present inventors have recognized, among other things, that because the optical sensors can provide information that may affect the treatment of a patient, it can be desirable to verify that the optical sensor is functioning normally, such as can include operating within a specified tolerance. The verification process can include taking a measurement with an optical sensor, and comparing one or more features of the measurement result to a reference result.
[0029] For example, if an optical sensor that is not functioning properly is used during a medical procedure, the procedure can be one or more of less precise, less efficient, or longer. In an example, the optical sensor can be a spectrometer. In this example, it can be desirable to verify that the spectrometer is providing accurate spectral data, such as in a specified spectral range of interest. If the optical sensor is functioning (e.g., producing optical data), but one or more portions of the data are inaccurate (e.g., one or more frequency bins within the spectrum of interest), some verification techniques can indicate that the optical sensor is functioning properly, even though the optical sensor may not be functioning properly across one or more regions.
[0030] In an example, an optical sensor can include or be included in a spectrometer. The verification process can include taking a measurement of a light having a particular spectrum and comparing the result of the measurement to a reference spectrum corresponding to the particular spectrum. The reference spectrum can represent a measured, specified, or calibrated spectrum. The reference spectrum can be configured such that a properly functioning optical sensor measuring the light having the particular spectrum produces a response that substantially matches the reference spectrum.
[0031] The present inventors have recognized, among other things, that it can be desirable for the verification process to happen automatically or at least partially automatically, such as without requiring input from a clinician, initiation by a clinician, or both. The verification process should be robust enough to be performed in a variety of environments and / or conditions.
[0032] One or more examples can be desirable and / or advantageous at least in part because it might not be necessary to calibrate the spectrometer for each use, (e.g., each use on a target, each time a procedure is performed). Instead, the spectrometer can be calibrated, such as before use, such as to generate a reference spectrum. Then, duringDocket No. 5409.875WO1 a procedure, a measured spectrum can be compared to the reference spectrum established before use, such as can complete the during use calibration.
[0033] FIG. 1 illustrates an example of locations for placement of one or more optical components within a laser system 100. The laser system 100 can be coupled to or inserted into an endoscopic system, such as an in-vivo insertable therapeutic or diagnostic endoscopic system, for performing patient diagnosis or treatment. Details regarding how the laser system 100 can be connected to an endoscopic system can be found in U.S. Patent Application 16 / 984,447, the contents of which are incorporated by reference in their entirety. In the example illustrated in FIG. 1 , a first optical component 102 such as a laser filter or a polarizer can be located at the output of an aiming beam emission source (e.g., a laser diode) 116 in a signal pathway of the aiming beam 104. The system can also include a light source 118 (e.g., a laser module or component), which can emit a signal such as laser radiation to ablate tissue, break up a stone (e.g., a kidney stone or a gallstone) or perform any suitable therapeutic or diagnostic procedure, and can emit signals in the visible spectrum or the non-visible spectrum. The first optical component 102 can be at least equal to or slightly larger than the diameter of the aiming beam 104. The first optical component 102 can remove the sources of noise (e.g., the spectrum spread of the main frequency / wavelength of the aiming beam 104), which can significantly improve the signals detected from the target 106.
[0034] Thus, in the example of FIG. 1, a signal emitted from the aiming beam emission source 116 can be filtered, attenuated, blocked, polarized, or otherwise affected by the first optical component 102, so that only signals of desired wavelengths and intensities are emitted from the surgical fiber 108 and reach the target 106. In an example, at least a portion of a signal emitted from the surgical fiber 108, another light source (e.g., an LED or Xenon light source, such as a visual illumination beam), or both, can be reflected back from the target 106 (as denoted by the arrows). The laser system 100 can additionally include one or more additional optical components (e.g., second optical component(s)), such as one or more notch filters 110 and 112 (or any suitable filter(s)) located in an optical path between the target 106 and the spectrometer located in the feedback box 114. The notch filters 110 and 112 can be used to remove any reflection signals reflected back from the target 106 with frequencies or wavelengths around, near, or substantially close to those of the aiming beam 104.
[0035] In an example, the width of high attenuation wavelengths of the notch filters 110 and 112 (or any suitable filter(s)) can be greater than the Full Width at HalfDocket No. 5409.875WO1Maximum (FWHM) specification of the aiming beam emission source 116 since the intensity of the aiming beam 104 can be orders of magnitude greater than the signal from the target (e.g., a spectroscopic signal). Therefore, even an apparently steep wavelength rise provided by the first optical component 102, or directly from the aiming beam emission source 116 can have an unacceptable level of interference at the tails of the emission pulse, or at the first optical component 102.
[0036] Additionally, or alternatively, one or more third optical components 120, 122 (e.g., a lens) located at or near the output of the aiming beam 104 as it passes through the first optical component 102 (not shown) and / or the optical path between the target 106 and the spectrometer in the feedback box 114can be coated with a suitable material to provide, replace, or enhance the filtering effects provided by the first optical component 102 and / or the notch filters 110, 112.
[0037] Furthermore, as discussed above, any of the first optical component 102, the second optical component 120, and / or the third optical component 122 can be a polarizer that can be used to improve the spectroscopic analysis. In another example, polarizers can be used in conjunction with, as a replacement for, the other optical components such as filters. In an example, one or more additional optical components 124, 126 can be used to aid or assist with directing the aiming beam 104. For example, first additional optical component 124, can be located in front of the aiming beam emission source 116, which can be a laser diode, or a light emitting diode (LED), and aid in directing the aiming beam 104 in a first direction (e.g., horizontally or in the “x” direction). Similarly, a second additional optical component 126 can be located near a VIS lens 128 (or any lens optimized to operate in the visible spectrum of light, or a range of 701-700 nanometers (nm)) and direct beams in a direction substantially perpendicular to the first direction (e.g., vertically or in the “y” direction). The second additional optical component 126 can thus block the aiming beam. Therefore, the optical feedback signal from the target can be transmitted through a VIS optical port to the spectrometer in the feedback box 114.
[0038] The laser radiation emitted from the light source 118 may have the same or different wavelength or frequency from that of the aiming beam 104 emitted from the aiming beam emission source 116. It is understood that any of the optical components discussed above can be used to block, attenuate, redirect, or the like, a portion of the laser radiation associated with the aiming beam 104 that is either emitted from the aiming beam emission source 116 or returned from the target 106 during a medical procedure.Docket No. 5409.875WO1
[0039] The frequency associated with the specification of any of the optical components, such as the first optical component 102, the notch filters 110, 112, or the like, can be dependent on the wavelength of the aiming beam 104. The wavelength of the aiming beam 104 may drift or vary by an amount, such as 1-2 nanometers due to external factors (e.g., temperature) and thus the one or more optical components can be selected to account for such a drift. For example, one or more of the optical components can be selected that have a wavelength range or spread, such as a 10 nm range, to account for the wavelength drift of the aiming beam 104. Additionally, or alternatively, an optical component such as a laser fdter can be selected to be optimized for the specific aiming beam emission source 116 (e.g., aiming beam laser diode) being used. For example, a rejection frequency of one or more of the optical components can be based on a wavelength of the aiming beam emission source 116 so as to reject frequencies that correspond to that aiming beam wavelength. The various optical components and filters discussed above can be included within a light impenetrable housing that can be coupled to an internal laser fiber 130, which can in turn be coupled to the light source 118, the surgical fiber 108, and / or the feedback box 114.
[0040] FIG. 2 illustrates an example of portions of a laser system 200. The laser system 200 can include a laser fiber 202 that can be housed or carried in a light-absorbent housing. FIG. 2 illustrates a system 200 including optical components that can be the same as or similar to those illustrated and discussed above with respect to FIG. 1. In FIG. 2, the laser fiber 202 can be coupled to a housing 204, such as which can house certain of the optical components (e.g., the first lens 214, the second lens 216, the first reflector 212, and the second reflector 206). The housing 204 can be configured to absorb light reflected off of an optical component housed therein. For example, the housing 204 coupled to the internal laser fiber 202 can be formed from or coated with a material that can substantially (e.g., 90% or, in some embodiments, 80%) absorb (e.g., not reflect) light of a specific wavelength or range of wavelengths within which the light from an aiming beam 208 is included. Light from the laser fiber 202 can pass through the first lens 214, the first reflector 212, the second reflector 206, and the second lens 216 before reaching the surgical fiber. The components inside the housing 204 can include optical couplers, or can form an optical couple. For example, the components within the housing 204 can optically couple the laser fiber 202 to the surgical fiber. In an example, the second reflector 206 can perform the same or similar function as the second additional optical component 126 as described for FIG. 1, specifically to direct light from theDocket No. 5409.875WO1 aiming beam 208. The second reflector 206 can direct light in a direction toward the housing 204 (as denoted by the arrow pointing from the aiming beam 208 toward the housing 204). Thus, light from the aiming beam 208 (and / or reflections from the target) and directed by the second reflector 206 toward the housing 204 can be absorbed by the housing 204 in this embodiment. This can effectively cause the stray light of the aiming beam 208 and / or the reflections from the target to be at least partially blocked and reduce or lower its amount before reaching the spectrometer 210.
[0041] FIG. 3 illustrates an example of portions of the laser system of FIG. 2 without a laser fiber connected and with the laser dust door 318 closed. In FIG. 3, the laser fiber 202 can be de-coupled from the housing 204 and the dust door 318 can be closed. The dust door 318 can be configured to enclose or otherwise protect the portion of the housing 204 to which the laser fiber 202 couples. The dust door 318 can close automatically or manually. The dust door 318 can be configured to absorb a portion or all of the light received from the housing 204, or can be configured to reflect a portion or all of the light received from the housing 204. The dust door 318 can be configured to block a portion or all of the light that is external to the housing 204 that hits the dust door 318.
[0042] FIG. 4 is a schematic diagram of an example of portions of an endoscopy system 400. The endoscopy system 400 can include an imaging and control system 404 and an endoscopic device (e.g., endoscope 408). The endoscopy system 400 of FIG. 4 is an illustrative example of an endoscopy system suitable for use with the systems, devices and methods described herein.
[0043] The endoscope 408 can be insertable into an anatomical region for one or more of imaging, treatment (e.g., via lithotripsy) of a target, or attachment to (e.g., via tethering) one or more sampling devices for biopsies, or one or more therapeutic devices for treatment of a disease state associated with the anatomical region. The endoscope 408 can interface or connect to imaging and control system 404. The endoscope 408 can also include one or more of a duodenoscope, laparoscope, ureteroscope, arthroscope, other endoscope or other instrument capable of being used for accessing a region inside a patient. The imaging and control system 404 can include a control unit 412, a display unit 416, an input unit 420, a light source (or an endoscopic light source) 124, a fluid source 428, and a suction pump 432.
[0044] The imaging and control system 404 can include various ports for coupling with the endoscopy system 400. For example, the control unit 412 can includeDocket No. 5409.875WO1 a data input / output port for receiving data from and communicating data to the endoscope 408. The light source (e.g., an LED light source or a Xenon light source) 324 can include an output port for transmitting light to the endoscope 408, such as via a fiber optic link. The fluid source 428 can include a port for transmitting fluid to the endoscope 408. The fluid source 428 can include, for example, a pump and a tank of fluid or can be connected to an external tank, vessel, or storage unit. The suction pump 432 can include a port used to draw a vacuum from the endoscope 408 to generate suction, such as for withdrawing fluid from the anatomical region into which a distal portion of the endoscope 408 is inserted. The display unit 416 and the input unit 420 can be used by an operator of the endoscopy system 400 to control functions of the endoscopy system 400 and view output of the endoscope 408. The control unit 412 can additionally be used to generate signals or other outputs from treating the anatomical region into which the endoscope 408 is inserted. For example, the control unit 412 can generate a signal to control the endoscopy system 400 to produce one or more of an electrical output, an acoustic output, a fluid output, or the like for treating the anatomical region such as for cauterizing, cutting, freezing, or the like.
[0045] The endoscope 408 can include an insertion section 436, a functional section 440, and a handle section 444, which can be coupled to a cable section 448 and a coupler section 452. The insertion section 436 can extend distally from the handle section 444, and the cable section 448 can extend proximally from the handle section 444. The insertion section 436 can be elongated and include a bending section, and a distal end to which the functional section 440 can be attached. The bending section can be controllable (e.g., by a steering control 456 on the handle section 444) to maneuver the distal end through tortuous anatomical passageways (e.g., stomach, duodenum, kidney, ureter, trachea, lungs, or the like). The insertion section 436 can also include one or more working channels (e.g., an internal lumen) that can be elongated and can support the insertion of one or more therapeutic tools (e.g., the surgical fiber 108) of the functional section 440, such as a ureteroscope. The working channel can extend between the handle section 444 and the functional section 440. Additional functionalities, such as fluid passages, guide wires, and pull wires, can also be provided by the insertion section 436 (e.g., via suction or irrigation passageways, or the like).
[0046] A coupler section 452 can be connected to the control unit 412 to connect to the endoscope 408 to multiple features of the control unit 412, such as the input unit 420, the light source 424, the fluid source 428, and the suction pump 432.Docket No. 5409.875WO1
[0047] The handle section 444 can include the steering control 456 as well as the port 460. The steering control 456 can be a knob, lever, or other actuation mechanism or the like, which can be used to navigate the endoscope 408 within the patient. The steering control 456 can be connected to a pull wire, or other actuation mechanisms, extending through the insertion section 436. The port 460, as well as other ports, such as a port 464, can be configured to couple various electrical cables, guide wires, auxiliary scopes, tissue collection devices, fluid tubes, and the like to the handle section 444, such as for coupling with the insertion section 436. The examples shown in FIG. 4 and FIG. 5 are examples of endoscopes 408.
[0048] The imaging and control system 404 can be provided on a mobile platform (e.g., a cart 468) with shelves for housing the light source 424, the suction pump 432, an image processing unit 504 (FIG. 5), or the like. Alternatively or additionally, one or more components of the imaging and control system 404, shown in FIG. 4, FIG. 5, and FIG. 6 can be provided directly on the endoscope 408, such as to make the endoscope “self-contained.”
[0049] The functional section 440 can include one or more components for treating or diagnosing the anatomy of a patient. The functional section 440 can include an imaging device, an illumination device, and an elevator. The functional section 440 can further include optically enhanced biological matter and tissue collection and retrieval devices.
[0050] FIG. 5 is a schematic diagram of an example of portions of the endoscopy system 400 of FIG. 4 including an example of portions of the imaging and control system 404 and the endoscope 408. FIG. 5 schematically illustrates components of the imaging and control system 404 coupled to the endoscope 408. The imaging and control system 404 can include the control unit 412, which can include or be coupled to an image processing unit 504, a treatment generator 508, and a drive unit 512, as well as the light source 424, the input unit 420, and the display unit 416. The control unit 412 can include, or can be in communication with, an endoscope, a surgical instrument, and an endoscopy system 400. The endoscopy system 400 can include a device configured to engage tissue, a stone, or both, and collect and store a portion of that tissue or stone and through which imaging equipment (e.g., a camera) can view target tissue. The control unit 412 can be configured to activate a camera to view target tissues located distal to the endoscopy system.Docket No. 5409.875WO1
[0051] The coupler section 452 can be connected to the control unit 412, such as to connect the endoscope 408 to multiple features of the control unit 412, such as the image processing unit 504, the treatment generator 508, or the like. The port 460 can optionally be used to insert another instrument or device, such as a daughter scope or auxiliary scope, or an optical fiber (e.g., surgical fiber 108), a sampling needle, biopsy needle, ablation instrument, scalpel, or the like, into the endoscope 408. Such instruments and devices can be independently connected to the control unit 412 such as via the cable section 448. The port 464 can optionally be used to connect the coupler section 452 to various inputs and outputs, such as video, air, light and electric.
[0052] The image processing unit 504 and light source 424 can each interface with the endoscope 408 (e.g., at the functional section 440) by wired or wireless electrical connections. The imaging and control system 404 can accordingly illuminate an anatomical region (e.g., via an optical channel or an optical fiber integrated with the endoscope), collect signals representing the anatomical region, process signals representing the anatomical region, and display images representing the anatomical region on the display unit 416. The imaging and control system 404 can include the light source 424 to illuminate the anatomical region using light of a desired spectrum (e.g., broadband white light, narrow-band imaging using preferred electromagnetic wavelengths, and the like). A reflection (e.g., a reflection of of the target tissue) can be received and analyzed, such as analyzed by a spectroscope or spectrometer. For example, reflected light from the target (e.g., reflections of the light from the light source 424) can be captured and transmitted to a spectrometer 210, which can make one or more determinations about hte target tissue. The imaging and control system 404 can connect (e.g., via an endoscope connector) to the endoscope 408 for signal transmission (e.g., light output from the light source, video signals from the imaging system in the distal end, diagnostic and sensor signals from a diagnostic device, and the like).
[0053] The fluid source 428 (shown in FIG. 4) can be in communication with control unit 412 and can include one or more sources of air, saline, or other fluids, as well as associated fluid pathways (e.g., air channels, irrigation channels, suction channels, and the like) and connectors (barb fittings, fluid seals, valves, and the like). The imaging and control system 404 can also include a drive unit 512, which can include a motorized drive for advancing a distal section of endoscope 408.
[0054] FIG. 6 is a drawing of an example of portions of an endoscopy system 400 for verifying an endoscopically-associated optical sensor and portions of anDocket No. 5409.875WO1 environment in which the laser system 100, 200 and endoscopy system 400 can be used. In the example of FIG. 6, the endoscopy system 400 can include an endoscope body 612, an endoscope insertion tip 608, and a control unit 412. The endoscopy system 400 may be a therapeutic system for conducting a procedure inside a patient. The environment may include a target 602 including a target region 604, a first surrounding tissue or organ 605, a second surrounding tissue or organ 606, and a target location 607.
[0055] The light source may include a xenon light source, a visible light emitting diode (LED) or an array of LEDs. The light source may emit a single wavelength of light, or multiple wavelengths. The light beam may illuminate a larger area around the target as opposed to a small area or point. The light beam may also illuminate an area within the target 302. The endoscope insertion tip 608 may include a therapy beam emitter 609, a secondary beam emitter 610, and an optical sensor 611. The therapy beam emitter 609, the secondary beam emitter 610, and the optical sensor 611 may be one or more of directed, aimed, or pointed at the target location 607 of the target 602. The therapy beam emitter 609 may have one or more of a focus or field of view that includes a portion of the target location 607, all of the target location 607, or more than all of the target location 607. The secondary beam emitter 610 may have one or more of a focus or field of view that includes a portion of the target location 607, all of the target location 607, or more than all of the target location 607. The optical sensor 611 may have one or more of a focus or field of view that includes a portion of the target location 607, all of the target location 607, or more than all of the target location 607. The one or more of a focus or field of view for the therapy beam emitter 609, secondary beam emitter 610, and optical sensor 611 may not overlap, may partially overlap, may completely overlap, or any combination thereof.
[0056] The therapy beam emitter 609 may be a laser, such as may include an infrared laser. The therapy beam emitter 609 can include or be included in the laser system 100 or the laser system 200, such as discussed with respect to FIG. 1 and FIG. 2. The therapy beam emitter 609 may emit a therapy beam 627. The therapy beam 627 may be used in a medical procedure or surgery, such as may be used to ablate, coagulate, vaporize, dust or fragment a target (e.g., a ureteral stone) at a target location 607. In an example, the therapy beam emitter 609 may be a variable power pulsing laser in the infrared spectrum with a wavelength of approximately 1940 nanometers (nm). The therapy beam emitter 609 may generate the therapy beam 627 locally, or the therapy beam 627 may be generated remotely, such as in the control unit 412. The therapy beamDocket No. 5409.875WO1627 may be carried through the endoscope body 612 to the therapy beam emitter 609, such as may include using an optical fiber or bundle. The therapy beam 627 may be concentrated in a small region or area or may be a wide beam. The therapy beam 627 may have an adjustable power level (e.g., by adjusting an intensity of the pulses). The therapy beam 627 may have an adjustable average power level such as can be adjusted using pulse width modulation (PWM) to adjust a duty cycle of the therapy beam 627.
[0057] The secondary beam emitter 310 may emit a secondary beam 628. The secondary beam emitter 610 may generate the secondary beam 628 locally, or the secondary beam 628 may be generated remotely, such as in the control unit 412. The secondary beam 628 may have an adjustable power level. This may adjust the average power of the secondary beam 628 by using PWM to adjust the duty cycle or bundle. The secondary beam 628 may be carried through the endoscope body 612 to the secondary beam emitter 610, such as may include using an optical fiber. In an example, both the therapy beam and the secondary beam may be generated remotely (e.g., in the control unit 412) and the therapy beam emitter 609 and the secondary beam 628 can include the tip of a laser fiber. In an example, the therapy beam emitter 609 and the secondary beam628 can be included in the same laser fiber (e.g., both the therapy beam and the secondary beam are emitted from the same laser fiber).
[0058] The secondary beam 628 may include a visible aiming beam to allow an operator of the endoscopy system 400 to visualize where the therapy beam 627 is directed. The visible aiming beam may include a visible aiming laser beam. This may include a green visible laser beam with a wavelength of approximately 515 nm. The visible aiming beam may be generated by a laser diode. The visible aiming beam may be directed to a region next to the region the therapy beam 627 is directed, or may be directed at the same region as the therapy beam 627. The visible aiming beam may be concentrated in a small region or area, or may be a wide beam. An intensity of the visible aiming beam may be adjusted. This may include one or more of adjustment by the operator or automatic adjustment by the control unit 412. In an example, the intensity of the visible aiming beam may be decreased when the endoscope insertion tip 608 is in water or another liquid as compared to when the endoscope insertion tip 608 is in a gas.
[0059] The secondary beam emitter 610 may additionally or alternatively include a visible light source to emit a secondary beam 628 in the form of a visible light beam. The visible light beam may allow an operator to see the environment in which the endoscope insertion tip 608 is located. This may include seeing the target 602. TheDocket No. 5409.875WO1 visible light source may include a xenon light source, a visible light emitting diode (LED) or an array of LEDs. The visible light source may emit a single wavelength of light, or multiple wavelengths. The visible light beam may illuminate a larger area of the target 602 as opposed to a small area or point. The visible light beam may also illuminate an area around the target 602.
[0060] In an example, there may be a visible aiming beam emitter (e.g., green laser diode) whose focus coincides with the focus of the therapy beam for allowing a physician to accurately locate the therapy beam on the target. In addition, the endoscopic light source 120 (e.g., LED(s) or xenon light source) can provide a visible illumination light beam.
[0061] The optical sensor 611 may be configured to collect or obtain optical data from the target location 607. The optical sensor 611 may have a field of view 629. The optical sensor 611 may collect optical data including one or more of overall intensity, the intensity at various spectra, images, and / or other optical data. The optical data collected by the optical sensor 611 may be able to provide information about a characteristic of the target 602. The optical sensor 611 need not be located in the endoscope insertion tip 608, but may receive transmitted light from the endoscope insertion tip 608, such as may include transmission using an optical fiber. The optical sensor 611 can be endoscopically-associated, such as can include an endoscopically- associated optical sensor (e.g., a spectrometer, such as the spectrometer 210). For example, the optical sensor 611 can be one or more of included in an endoscope system (e.g., included in the endoscopy system 400, such as is shown in FIG. 6), used in conjunction with an endoscope system (e.g., used with the endoscopy system 400, such as an optional component and / or separate system), used with and / or during an endoscopic procedure, or otherwise associated with an endoscope or endoscopic procedure.
[0062] The target 602 may include a target on or within a patient. The target 602 may include one or more of a tumor or calculi. The target 602 may be accessed by using an endoscope, such as may be used in endoscopic procedures or surgery.
[0063] The first surrounding tissue or organ 605 may include any tissue or organ on or within a patient, such as may include a kidney or kidney tissue. The second surrounding tissue or organ 606 may be the same organ or tissue as the organ 605, or may be a different organ or tissue. The organ 605 and the organ 606 may be near theDocket No. 5409.875WO1 target location 607, and may be exposed to the conditions of the target location 607, such as may include one or more of a temperature or pressure in the target location 607.
[0064] The endoscope body 612 may connect the control unit 412 to the endoscope insertion tip 608. The endoscope body 612 may be rigid or may be flexible in one or more regions. The endoscope body 612 may include one or more channels, such as for one or more instruments or other features to transmit signals, beams, and / or fluids to or from the endoscope insertion tip 608. The endoscope body 612 may include an irrigation path and a suction or other irrigation return path, such as may allow the irrigation controller 624 to provide irrigation flow to and from the target location 607. The endoscope body 612 may contain one or more lumens or other mechanical structures for transmitting one or more of instruments or tissue to and from the endoscope insertion tip 608. The endoscope body 612 may be included in one or more of a laparoscope, ureteroscope, arthroscope, other endoscope or other instrument capable of being used for accessing a target region 604 inside a patient.
[0065] The control unit 412 may include circuitry and other componentry, such as a processor 614, a memory 616, a response unit 618, a visible display 620, a laser controller 622 (e.g., to control the laser system 100 or the laser system 200), an irrigation controller 624 coupled to an irrigation system, and / or a spectroscopic controller 326 coupled to a spectrometer. The control unit 412 may be connected to other equipment, such as may include a therapy beam generator, a secondary beam generator, an irrigation system, or a spectroscope. The therapy beam generator or secondary beam generator may be communicatively coupled with the control unit 412. The control unit 412 may be configured to control one or more of the therapy beam generator or secondary beam generator. The processor 614 may include circuitry that can receive signals transmitted from the optical sensor 311 and, based thereon, verify the operation of the optical sensor 611. Either or both of the laser controller 622 or the irrigation controller 624 may use controller circuitry that can be separate from the control unit 412.
[0066] The processor 614 may include circuitry that can be configured to process data from the optical sensor 611. The spectroscope may include circuitry and / or optics that can be configured to perform spectroscopic analysis on the data from the optical sensor 611. The spectroscope may be separate from the control unit 412, such as may include the spectroscope operating on a separate system and / or device. The spectroscope may be communicatively coupled to the control unit 412. This may allow the controlDocket No. 5409.875WO1 unit 412 to one or more of interface with the spectroscope or control operation of the optical sensor 311.
[0067] The response unit 618 may communicate with the processor 614 and may trigger a response to the determination of a cumulative exposure level or other condition. For example, the response unit 618 may be coupled to one or more feedback systems within the endoscopy system 400 for informing or alerting an operator. The operator may include a physician. The feedback system may include at least one of a visible display 620, a speaker or other audible sound generation device, or a touch or haptic alert system. The response unit 618 may be coupled to one or more operational systems within the endoscopy system 400, such as may include the laser controller 622 or the irrigation controller 624. The response unit 618 may be able to one or more of establish, adjust, or tune one or more parameters of these operational systems, such as may be done in response to a determined operating condition.
[0068] The visible display 620 may include a color or black-and-white screen, and may display text, figures, symbols, or other visual information. The visible display 620 can be coupled to the display unit 416, such as can include displaying information received from the display unit 416. At least a portion of the screen may flash to gain the operators attention. The visible display 620 may display one or more of the instantaneous temperature, the instantaneous fluid pressure, the rate of change of temperature, or the rate of change of fluid pressure. The visible display 620 may include one or more visual indicators of the change in a measured value, such as may include a red up arrow or a green down arrow. These visual indicators may be displayed in the vicinity of the instantaneous measured value. Visible indications include one or more of graphs and / or charts showing trends and / or rates of change, arrows, colors, or icons displayed on one or more of the visible display 620, or one or more other procedure monitors.
[0069] The speaker or other sound generation device may be configured to alert the operator audibly, such as may allow the operator to be alerted when the operator is not looking at the visible display 620. The touch or haptic alert system may send a touch signal to a portion of the endoscopy system 400 that is usually touched or held by an operator, such as may include and endoscope handle or one or more endoscopic controls or input systems. The touch or haptic alert may vibrate, pulse, or change the shape of the portion of the system touched or held by the operator.
[0070] The response unit 618 may also be configured to control one or more parameters (e.g., system parameters), such as of one or more of the laser controller 622Docket No. 5409.875WO1 or the irrigation controller 624. For example, the response unit 618 may be able to disable or otherwise shut off the therapy beam 627, or adjust a power level and / or duty cycle of the therapy beam 627. The response unit 618 may be able to one or more of disable, stop, or otherwise shut off an irrigation flow. The response unit 618 may be able to one or more of reduce or adjust a parameter (e.g., flow rate or pressure) associated with the irrigation flow. The response unit 618 may be configured to perform such responsive operations automatically (e.g., without requiring user input) or semi-automatically (e.g., requesting user confirmation before performing the responsive operation).
[0071] FIG. 7 is a diagram showing an example of portions of a method 701 of operating a system for verifying an optical sensor (e.g., a spectrometer). One or more steps of the method 701 can be performed using a system such as the laser system 100, the endoscopy system 400, or both, such as is illustrated in various examples throughout FIG. 1, FIG. 2, FIG. 4, FIG. 5, and FIG. 6, and described with respect to the same figures.
[0072] At step 702, a verification light source (e.g., the light source 424 or the secondary beam emitter 610) can be activated to emit a first optical signal. The optical signal can have a specified spectrum or a specified range of spectra, which can be determined, measured, or calibrated prior to performing the verification method 701 described herein (e.g., during manufacturing). In an example, the light source 424 can be used after the surgical fiber is coupled to the endoscopy system 400, which can include the light source 424 being used after the surgical fiber is inserted into a patient. In an example, the secondary beam emitter 610 can be used prior to the surgical fiber being coupled to the endoscopy system 400, which can include the secondary beam emitter 610 being used prior to inserting a portion of the system into a patient. In an example, the secondary beam emitter 610 can emit the aiming beam as described above prior to inserting the laser fiber into the patient, alternatively, and the light source (e.g., LED or Xenon light source) 424 can emit illumination after the surgical fiber is inserted into a patient (e.g., the approach for verifying / calibrating an optical sensor may be based on whether the surgical fiber is coupled and / or inserted into an optical coupler depicted in FIGs. 1-3). The verification light source can have functions in the system beyond verifying proper or correct operation of the optical sensor 611. Activating the verification light source can include one or more of enabling the verification light source, turning the verification light source on, or adjusting an intensity and / or a duty cycle of the verification light source. The verification light source can be on continuously or recurrently, and activating the verification light source can include maintaining theDocket No. 5409.875WO1 verification light source in the on condition. The verification light source can be controlled and / or generated by a system separate from the system for verifying an optical sensor (e.g., spectrometer), and activating the verification light source can include determining that the verification light source is already activated.
[0073] At step 703, a first spectrum can be measured using an optical sensor (e.g., a spectrometer). The first spectrum can correspond to the first optical signal, such as can include configuring the optical sensor and / or the verification verification light source such that light emitted by the verification verification light source (e.g., directly transmitted light, reflected light, scattered and reemitted light, etc. from, for example, the target and / or the optical coupler) is received by the optical sensor. The optical sensor can be configured to receive light from the verification verification light source due to one or more of a proximity to the verification verification light source, being directed towards the verification verification light source, or being directed towards an object, an optical coupler, or field of view that the verification verification light source is directed to. The first spectrum can correspond to the specified spectrum of the verification light source.
[0074] The verification light source can include the secondary beam emitter 610 operating as an aiming beam emitter (e.g., emitting a laser beam, such as a laser beam in the green light of the visible spectrum). In this example, the secondary beam 628 and the field of view 629 can at least partially overlap, such as can result in the optical sensor 611 receiving a spectrum of light corresponding to the secondary beam 628. The secondary beam emitter 610 and the optical sensor 611 can be included in a laser fiber system for an endoscopic system, such as the endoscopy system 400. In this example, the secondary beam 628 can be directed down the laser fiber and the field of view 629 can include light received by the laser fiber. In this example, light from the secondary beam 628 that is scattered and reflected off of one or more of the sides of the laser fiber, a tip of the laser fiber, or imperfections within the laser fiber can be received by the optical sensor 611. A connection between the secondary beam emitter 610 and the optical sensor 611 with the laser fiber can also be a source of light from the secondary beam emitter 610 that is received by the optical sensor 611. For example, the interface with the laser fiber might generate a level of reflected phenomena from the secondary beam emitter 610 that can be received by the optical sensor 611. In this example, the first spectrum can be measured even when a laser fiber is not connected, such as due toDocket No. 5409.875WO1 the internal reflections and scattering within an optical coupler directly or indirectly coupling the secondary beam emitter 610 and the optical sensor 611.
[0075] One or more of the endoscope, a laser or the optical sensor 611 used by the endoscope may include a cover and / or shield (e.g., a dust cover). For example, a cover can be placed over the endoscope insertion tip 608, or a port for coupling the surgical fiber 108 to the laser system 100. This cover can naturally direct light from the secondary beam emitter 610 to the optical sensor 611 or can be specially configured to do so. This cover can also block at least a portion of an ambient light level, such as due to the cover being opaque or partially opaque. The shield can be configured to be connected in place of an optical fiber or optical fiber bundle, such as can protect one or more portions of the endoscopic system when a fiber is not connected.
[0076] The first spectrum can include one or more of a light intensity level, an average light intensity level, an intensity level of various frequency ranges (e.g., a spectroscopic range of frequency bins), etc. The first spectrum can be generated by the spectroscopic controller 626 using light received from the optical sensor 611.
[0077] At step 707, the first spectrum can be compared to a reference spectrum such as to determine whether the optical sensor is operating within a specified tolerance. For example, the reference spectrum can be acquired during manufacturing to represent a spectrum corresponding to the verification light source. Comparing the first spectrum to the reference spectrum can include comparing the shape of the first spectrum to the shape of the reference spectrum. For example, the first spectrum can have a shape defined by the intensity level of the spectrum at a range of frequencies, and this shape can be compared to a similarly defined shape for the reference spectrum. If the shapes substantially match to a specified degree, it can be determined that the optical sensor is operating within the specified tolerance. The specified tolerance can be configurable by a user, or it can be programmed into the system. The specified tolerance can be determined based upon a level of accuracy needed from the optical sensor to make accurate decisions, such as can include accurate decisions regarding one or more of patient treatment, system adjustment, or clinician advisement. The specified tolerance can include a percentage deviation from the reference spectrum, such as three percent deviation, five percent deviation, or 10 percent deviation.
[0078] At an optional step 708, which, in one embodiment, can be included in step 707, one or more of the first spectrum or the reference spectrum can be normalized. Normalizing a spectrum can include scaling the spectrum (e.g., multiplying a determinedDocket No. 5409.875WO1 intensity of each of the frequency bins by the same multiple, such as can include a multiple less than 1.0, such as is discussed with respect to FIG. 12B below) so that the average intensity level is equal to a normalized value, such as can include 1.0. Normalizing one or more spectra can allow the spectra to be compared based on spectral composition without being affected by the overall intensity of the spectra. For example, if the reference spectrum has a higher average intensity than the first spectrum, comparing the spectra can be more difficult without first normalizing one or more of the spectra.
[0079] At an optional step 711, which, in one embodiment, can be included in step 707, a deviation in intensity, such as the normalized intensity determined in step 708, can be determined between corresponding frequencies (e.g., frequency bins) of the first spectrum and the reference spectrum. For example, a normalized intensity value of a first frequency or frequency range of the first spectrum can be compared to the corresponding normalized intensity value the reference spectrum, and if the two intensities are substantially in agreement, it can be determined that the optical sensor is within a specified tolerance, or within a specified tolerance at least for that frequency range. Comparing normalized spectra is discussed further with respect to FIG. 9 below.
[0080] One or more of steps 704 through step 706 can optionally be performed, such as to adjust for a background light level present during one or more verification steps. This can result in an adjusted spectrum that is used in place of the first spectrum in step 707. At step 704, the verification light source can be activated to emit a second optical signal. The second optical signal can be emitted by the same verification light source as the first optical signal. The second optical signal can correspond to the verification light source emitting a different intensity of light than the first optical signal. For example, the second optical signal can include a signal emitted when the verification light source is turned off.
[0081] At step 705, a second spectrum can be measured using the optical sensor. The second spectrum can correspond to the second optical signal. In the example in which the second optical signal includes the verification light source being off, the second spectrum can represent a background spectrum. For example, the second spectrum can correspond to ambient and / or background light received by the optical sensor. This ambient light can include any light that is not emitted by the verification light source, such as light from another light source, including one or more of room lighting, surgical lighting, etc.Docket No. 5409.875WO1
[0082] The second spectrum can be measured near in time to measuring the first spectrum, such as can include within one millisecond, 10 milliseconds, 300 milliseconds, one second, five seconds, 10 seconds, or 60 seconds. Measuring the second spectrum near in time to measuring the first spectrum can help a noise level in the second spectrum more nearly match a noise level in the first spectrum. For example, if one or more of a position of the verification light source, position of the optical sensor, orientation of the verification light source, orientation of the optical sensor, or ambient light level change, the background effects on the optical sensor can change. This can make it desirable to measure the second spectrum near in time to the first spectrum, such as can minimize a change in background noise level received by the optical sensor, such as can improve the noise removal accomplished by subtracting the second spectrum from the first spectrum.
[0083] At step 706, an adjusted spectrum can be determined using the first spectrum and the second spectrum. For example, the first spectrum can be adjusted based on the second spectrum to arrive at the adjusted spectrum. Following determining an adjusted spectrum, the method can proceed to step 707, where the adjusted spectrum can be used in place of or in addition to the first spectrum (e.g., comparing the adjusted spectrum to the reference spectrum).
[0084] The adjusted spectrum can be determined by subtracting the second spectrum from the first spectrum, such as can remove a common mode between the first spectrum and the second spectrum. For example, an intensity value for each frequency bin in the second spectrum can be subtracted from corresponding intensity values in the first spectrum to arrive at the corresponding adjusted spectrum intensity values. In the example where the second spectrum represents a background spectrum, this can result in an adjusted spectrum corresponding to the verification light source with background noise removed or at least partially filtered out. For example, by removing the background noise represented by the second spectrum from the first spectrum, which contains background noise in addition to a signal corresponding to the first signal from the verification light source, an adjusted spectrum corresponding to the first signal can be determined, such as can include a zero (or at least lower) noise level than the first spectrum. In an example where the second spectrum is measured while the verification light source is emitting light, the adjusted spectrum can still have a reduced level of background noise.Docket No. 5409.875WO1
[0085] The reference spectrum can be configured to correspond to the spectrum that is compared to the adjusted spectrum. For example, when the reference spectrum can be compared to the first spectrum measured in step 703, the reference spectrum can configured to correspond to an unadjusted first spectrum. For example, the reference spectrum can correspond in the intensity of the first optical signal, the configuration of the laser system 100 (e.g., laser fiber connected, dust door shut, etc.), or both. In an example where the reference spectrum can be compared to an adjusted spectrum that can be generated at step 706, the reference spectrum can correspond to the adjusted spectrum (e.g., the same or similar intensities of the first optical signal, the second optical signal, laser fiber connected, dust door shut, etc.).
[0086] In an example, measuring the first spectrum at step 703 and comparing the first spectrum to the reference spectrum at step 707 can form a verification pass. In an example, the verification pass can include one or more other steps, such as the steps shown in FIG. 7 and discussed above. For example, the verification pass can include measuring a second spectrum at step 705, determining an adjusted spectrum at step 706, normalizing the adjusted spectrum at step 708, and comparing corresponding frequencies in the normalized spectrum to the reference spectrum at step 711. In an example, the method 701 can include performing two or more verification passes, such as can include two verification passes, three verification passes, four verification passes, or five or more verification passes. In an example, only a portion of the verification passes must be within the specified tolerance for the optical sensor to be deemed to be within the specified tolerance, such as can include only one of the verification passes being within the specified tolerance, only two of the verification passes being within the specified tolerance, or a majority of the verification passes being within the specified tolerance, etc.
[0087] The shown order of steps is not intended to be a limitation on the order the steps are performed in. In an example, two or more steps may be performed simultaneously or at least partially concurrently. In an example, one or more of the steps can be performed before a surgical fiber is coupled to the endoscopy system 400 (e.g., before a surgical fiber is inserted in the optical coupler) or the laser system 100 (e.g., before the surgical fiber 108 is coupled to the laser system 100). For example, a portion (e.g., all) of the steps in the method 701 discussed above can be performed before a surgical fiber is coupled to the endoscopy system 400. In an example, a portion (e.g., all) of the steps in the method 701 discussed above can be performed after a surgical fiber isDocket No. 5409.875WO1 coupled to the endoscopy system 400. In an example, one or more of the steps can be performed before an endoscopic medical procedure. For example, one or more of the steps can be performed before an endoscope is inserted into a patient. In an example, all of the endoscope verification steps undertaken to verify the endoscopically-adapted optical sensor can occur before the endoscope is inserted into the patient, such as during one or more of a pre-operation time, a pre-operation check routine, or a power-up routine. In an example, one or more of the steps can be performed without user input, such as can include one or more of the steps occurring automatically, such as when a system is initialized. In an example, one or more of the steps can be performed after the endoscope is inserted into a patient. In an example, one or more of the steps can be performed recurrently, such as at a specified interval during a procedure. For example, the optical sensor can be verified recurrently during an endoscopic procedure (e.g., every minute, every five minutes, every hour, etc.).
[0088] FIG. 8 is a diagram showing an example of a method 701 of operating a system for verifying an optical sensor. FIG. 8 shows that the method 701 can include additional steps following step 707.
[0089] At step 712, a machine-learning model can be used to compare the first spectrum to the reference spectrum. The machine learning model can be trained to recognize whether the optical sensor is operating within the specified tolerance by examining one or more features of the spectra, such as can include the shape of the spectra. For example, a batch of training spectra can be used to train the machinelearning model. The training spectra can be labeled as “within specified tolerance” or “not within specified tolerance,” and the machine learning model can be trained to recognize when the spectra show a “within specified tolerance” condition. In an example, the machine-learning model is trained for a specific reference spectrum and only receives the first spectrum during runtime. In an example, the machine-learning model is trained to receive both the first spectrum and the reference spectrum during runtime. This can be beneficial in a case where the reference spectrum is specific to a given endoscopy system 400, but the machine learning model is not trained for each endoscopy system 400.
[0090] At step 713, an action may be taken in response to the determination of whether the optical sensor is operating within the specified tolerance, for example, such as described further with respect to FIG. 11. For example, the system may disable and / or adjust one or more features of the medical device system (e.g., the therapy beam 627),Docket No. 5409.875WO1 such as to prevent harm to a patient. Additionally or alternatively, the system may propose at least one action to a user (e.g., via a user interface), and the at least one action may be one or more of accepted, rejected, or modified before the system takes the proposed action. For example, the system may determine that an action will help prevent harm to a patient due to an unverified optical sensor, and may inform the operator of the potential action. The operator may accept the action, at which point the system may take the action. The operator may reject the action, at which point the system may not take the action. The operator may modify the proposed action in one or more ways before accepting the action, at which point the system may take the modified action.
[0091] The shown order of steps is not intended to be a limitation on the order the steps are performed in. In an example, two or more steps may be performed simultaneously or at least partially concurrently.
[0092] FIG. 9 is a diagram showing an example of a method 701 of operating a system for verifying an optical sensor. FIG. 9 shows that the method 701 can include additional steps following step 711.
[0093] At step 902, an amount (e.g., a quantity, a number, etc.) of the deviations of normalized intensity between the first spectrum and the reference spectrum determined in step 711 within a specified deviation threshold can be determined. For example, if the spectra include 400 frequencies or frequency bins, a number of the frequencies for which the determined deviation is less than a specified deviation threshold value can be determined. The deviation threshold can be a specified threshold, such as can include a numerical and / or percentage deviation. In an example, the deviation threshold can include one or more of one percent, two percent, five percent, 10 percent, or 20 percent.
[0094] At step 904, the optical sensor can be deemed to be within the specified tolerance when the amount of the deviations below the deviation threshold determined in step 902 is above a specified bin count. In an example, the specified bin count can correlate to 99 percent of the frequency bins, 98 percent of the frequency bins, 95 percent of the frequency bins, 90 percent of the frequency bins, or 80 percent of the frequency bins.
[0095] In an example, only a portion of the first spectrum can be considered, or the first spectrum can include only a portion of the frequencies measured by the optical sensor. For example, the first spectrum may only be analyzed in or near the specified spectrum of the verification light source (e.g., only analyzing the portion of the spectrumDocket No. 5409.875WO1 corresponding to the aiming beam, such as can include the green portion of the visible spectrum). This can remove a need to filter out background light levels as the specified spectrum of the verification light source can overpower background light levels. In an example, only a portion of the frequency range of the optical sensor is actively verified, but the whole sensor range is deemed to be verified if the portion of the range passes the verification.
[0096] The shown order of steps is not intended to be a limitation on the order the steps are performed in. In an example, two or more steps may be performed simultaneously or at least partially concurrently.
[0097] FIG. 10 is a diagram showing an example of a method 900 of receiving and / or generating the reference spectrum, such as can be used in the method 701.
[0098] At step 1002, the reference spectrum can be received. Receiving the reference spectrum can include receiving the reference spectrum that is measured during a manufacturing process of the verification light source. For example, the reference spectrum can be programmed into the verification light source or its supporting system before one or more of shipment or use in medical procedures.
[0099] At step 1004, the reference spectrum can be generated following a calibration of the optical sensor. For example, the optical sensor can be calibrated, such as can include calibration during a manufacturing process. The optical sensor can be calibrated using one or more of specialized calibration equipment or specialized calibration techniques, which may or may not be difficult to replicate during everyday use of the system. In an example, the optical sensor, such as including a processing device (e.g., the spectroscope) that can measure a specified calibration spectrum, and then the response of the optical sensor can be adjusted to substantially match the calibration spectrum.
[0100] At step 1006, the verification light source can be activated to generate a third optical signal. The third optical signal can substantially match the first optical signal in intensity, or can differ in intensity. The third optical signal can have a specified spectrum similar to the first optical signal, such as can be due to the third optical signal being generated by the same verification light source as the first optical signal.
[0101] At step 1008, the optical sensor can measure a third spectrum corresponding to the third optical signal. The third spectrum can become the reference spectrum, such as can include being programmed into the system for use during optical sensor verification. Because the third spectrum corresponds to the signal generated byDocket No. 5409.875WO1 the optical sensor in response to the verification light source near in time to the calibration of the optical sensor, it can be a good reference for verification.
[0102] At step 1010, the third spectrum can be measured in an environment with controlled ambient light, such as can include a limited or otherwise minimized light level (e.g., a dark environment). This can help the third spectrum to correspond to the specified spectrum of the verification light source with a reduced level of background noise, such as can help future verifications in varying environmental conditions. In an example, a noise level can be filtered out of the reference spectrum, such as by subtracting a fourth spectrum corresponding to ambient light level during generating the reference spectrum.
[0103] The shown order of steps is not intended to be a limitation on the order the steps are performed in. In an example, two or more steps may be performed simultaneously or at least partially concurrently.
[0104] FIG. 11 is a diagram showing an example of a method 701 of operating a system for verifying an optical sensor. FIG. 11 shows that the method 701 can include additional steps following step 713.
[0105] At step 1102, a visual, audible, or haptic alert may be triggered, such as discussed above with respect to the response unit 618. For example, the method may include informing one or more of the operator, an equipment manager, or a facility operator that the optical sensor has not passed verification. In an example, the method can include informing one or more entities that the verification has passed, such as can include uploading validation information to a database, such as a central database, such as can ensure verification of the optical sensor occurred.
[0106] At step 1104, one or more parameters of the system may be adjusted, such as discussed above with respect to the response unit 618. For example, at step 1106, the energy delivered by the system may be reduced (e.g., reduced by lowering a laser power output). At step 1108, the energy delivered by the system may be shut off or otherwise inhibited (e.g., turning of a laser).
[0107] FIG. 12A is a graph showing an example of a first spectrum 1202 and a second spectrum 1204. FIG. 12A shows that the spectrum can be defined on a vertical axis 1206 and a horizontal axis 1208. The vertical axis 1206 can include a measure of intensity, such as can be expressed in arbitrary units (e.g., counts). The horizontal axis 1208 can include a representation of a frequency or wavelength (e.g., the speed of light divided by the frequency). In the example of FIG. 12A, the horizontal axis 1208 is represented in terms of wavelength.Docket No. 5409.875WO1
[0108] FIG. 12A shows that the first spectrum 1202, such as can be determined at step 707, can include some intensity at all visible light wavelengths (e.g., 400nm to 950nm), and can include a spike in the green spectrum (e.g., between 510nm and 550nm), such as can correspond to a green visible laser aiming beam. The spike due to the specified spectrum of the verification light source can be between a lower range of the specified spectrum 1214 and an upper range of the specified spectrum 1216.
[0109] FIG. 12A shows that the second spectrum 1204, such as can be determined at step 705, can include some intensity at all visible light wavelengths and no spike. In the example of FIG. 12 A, the second spectrum 1204 can represent a background spectrum measured when the verification light source is off. The second spectrum 1204 can generally match the first spectrum 1202 below the lower range of the specified spectrum 1214 and above the upper range of the specified spectrum 1216.
[0110] FIG. 12B is a graph showing an example of an adjusted spectrum 1212 determined using the first spectrum 1202 and the second spectrum 1204 of FIG. 12A and a reference spectrum 1210. The adjusted spectrum 1212, such as can be determined at step 706, can be determined by subtracting the second spectrum 1204 from the first spectrum 1202, such as at step 706. FIG. 12B shows that the adjusted spectrum 1212 can have an intensity that is substantially equal to zero everywhere except between the lower range of the specified spectrum 1214 and the upper range of the specified spectrum 1216. FIG. 12B shows that the reference spectrum 1210 can also be substantially equal to zero everywhere except between the lower range of the specified spectrum 1214 and the upper range of the specified spectrum 1216, such as an be due to the reference spectrum 1210 being measured in a controlled environment, such as at step 1010.
[0111] FIG. 12B also shows an adjusted spectrum before normalization 1218. The adjusted spectrum before normalization 1218 can represent the adjusted spectrum (e.g., determined at step 706) prior to normalizing the adjusted spectrum (e.g., at step 708). FIG. 12B shows that the adjusted spectrum before normalization 1218 can have the same general shape as the adjusted spectrum 1212, but can have a greater (e.g., as shown in FIG. 12B) or smaller average magnitude. Normalization can adjust an average magnitude of the adjusted spectrum before normalization 1218 to generate the adjusted spectrum 1212, which can include adjusting an average magnitude of the adjusted spectrum before normalization 1218 toward an average magnitude of the reference spectrum 1210 (e.g., matching a magnitude of the adjusted spectrum 1212 to the reference spectrum 1210).Docket No. 5409.875WO1
[0112] FIG. 13 is a graph showing an example of collected background spectra. In the example of FIG. 13, the data shown is laboratory recorded data. Light wavelength in nanometers is along the horizontal axis and ADC counts (e.g., accumulated light intensity) are along the vertical axis. FIG. 13 shows a background spectra with a 50 millisecond integration time 1302, a background spectra with a 10 millisecond integration time 1304, and a background spectra with a 1 millisecond integration time 1306. The integration time corresponds to a setting within the spectrometer 210, and can be related to a capture time. FIG. 13 shows that the longer the integration time, the larger the number of ADC counts (e.g., the more light that is received). FIG. 13 shows that the background spectra can be substantially even across a range of light wavelengths.
[0113] FIG. 14 is a graph showing an example of a spectra collected with the laser aiming beam on. In the example of FIG. 14, the data shown is laboratory recorded data. Light wavelength in nanometers is along the horizontal axis and ADC counts (e.g., accumulated light intensity) are along the vertical axis. FIG. 14 shows a spectra with laser aiming beam on 1402. The spectra with laser aiming beam on 1402 can have a significant beak around 620 nanometers.
[0114] FIG. 15 is a graph showing an example of a collected background spectra of and a collected spectra with the laser aiming beam on spectra on. In the example of FIG. 13, the data shown is laboratory recorded data. Light wavelength in nanometers is along the horizontal axis and ADC counts (e.g., accumulated light intensity) are along the vertical axis. FIG. 15 shows a spectra with the aiming beam on 1502 and a spectra with the aiming beam off 1504. In the example of FIG. 15, the spectra were collected without a laser fiber connected and the dust door closed, such as is shown in FIG. 3. FIG. 15 shows that in a dark environment with limited background noise (e.g., such as with the laser dust door shut), the spectra with the aiming beam off 1504 can have a very minimal magnitude as compared to the spectra with the aiming beam on 1502. In this example, the spectra with the aiming beam off 1504 can be subtracted from the spectra with the aiming beam on 1502 to generate the adjusted spectrum.
[0115] FIG. 16 shows a schematic diagram of a computer-based clinical decision support system (CDSS) 900 that is configured to control one or more aspects of the endoscopy system 400, based on input from any one of the components of the endoscopy system 400 (e.g., the optical sensor 611). In examples, the CDSS 1600 can include an input interface 1604 through which medical information, such as, age, weight, sex, which are specific to a patient, or procedure specific information, such as, location ofDocket No. 5409.875WO1 anomaly, planned path for the procedure, planned steps of the procedure, or the like, can be provided as input features to an artificial intelligence (Al) Al model 1606. A processor 1608 (e.g., control unit 412, processor 614) which performs an inference operation in which the input from any one of the components of the endoscopic system, signals transmitted based on engagement with either of the first engagement member or the second engagement member, medical information, procedure specific information, or the like, are applied to the Al model to generate a suggested medical procedure, and a user interface (UI) through which the suggested medical procedure is communicated to a user, e.g., a clinician.
[0116] In some embodiments, the input interface 1604 may be a direct data link between the CDSS 1600 and one or more medical devices (e.g., the endoscopy system 400), that generate at least some of the input features. For example, the input interface 1604 may transmit input from any one of the components of the endoscopic system, medical information, procedure specific information, or the like, directly to the CDSS 1600 during a therapeutic and / or diagnostic medical procedure. Additionally, or alternatively, the input interface 1604 may be a classical user interface that facilitates interaction between a user and the CDSS 1600. For example, the input interface 1604 may facilitate a user interface through which the user may manually enter medical information, procedure specific information, or the like. Additionally, or alternatively, the input interface 1604 may provide the CDSS 1600 with access to an electronic patient record from which one or more input features may be extracted. Such electronic patient records can be stored on a database 1602. In any of these cases, the input interface 1604 can be configured to collect one or more of the following input features in association with a specific patient on or before a time at which the CDSS 1600 is used to assess the safest and most efficient procedure to complete a planned medical procedure. The input features can include one or more of the first spectrum, the second spectrum, the reference spectrum, the adjusted spectrum, one or more parameters of the optical sensor 311, one or more parameters of the verification light source, or one or more parameters of the endoscopy system 100.
[0117] Based on one or more of the above input features, the processor 1608 performs an inference operation using the Al model 1606 to generate the safest and most efficient medical procedure to perform the medical task. For example, input interface 1604 may deliver any of the medical information, medical procedure information, outputs from any one of the components of the endoscopic system, or signals transmittedDocket No. 5409.875WO1 based on engagement with either of the first engagement member or the second engagement member into an input layer of the Al model 1606, which propagates these input features through the Al model 1606 to an output layer. The Al model 1606 can provide a computer system the ability to perform tasks, without explicitly being programmed, by making inferences based on patterns found in the analysis of data. The Al model 1606 explores the study and construction of algorithms (e.g., machine-learning algorithms) that may learn from existing data and make predictions about new data. Such algorithms operate by building an Al model from example training data in order to make data-driven predictions or decisions expressed as outputs or assessments.
[0118] There are two common modes for machine learning (ML): supervised ML and unsupervised ML. Supervised ML uses prior knowledge (e.g., examples that correlate inputs to outputs or outcomes) to learn the relationships between the inputs and the outputs. The goal of supervised ML is to learn a function that, given some training data, best approximates the relationship between the training inputs and outputs so that the ML model can implement the same relationships when given inputs to generate the corresponding outputs. Unsupervised ML is the training of an ML algorithm using information that is neither classified nor labeled, and allowing the algorithm to act on that information without guidance. Unsupervised ML is useful in exploratory analysis because it can automatically identify structure in data.
[0119] Common tasks for supervised ML are classification problems and regression problems. Classification problems, also referred to as categorization problems, aim at classifying items into one of several category values (for example, is this object an apple or an orange?). Regression algorithms aim at quantifying some items (for example, by providing a score to the value of some input). Some examples of commonly used supervised-ML algorithms are Logistic Regression (LR), Naive-Bayes, Random Forest (RF), neural networks (NN), deep neural networks (DNN), matrix factorization, and Support Vector Machines (SVM).
[0120] Some common tasks for unsupervised ML include clustering, representation learning, and density estimation. Some examples of commonly used unsupervised-ML algorithms are K-means clustering, principal component analysis, and auto-encoders.
[0121] Another type of ML is federated learning (also known as collaborative learning) that trains an algorithm across multiple decentralized devices holding local data, without exchanging the data. This approach stands in contrast to traditionalDocket No. 5409.875WO1 centralized machine-learning techniques where all the local datasets are uploaded to one server, as well as to more classical decentralized approaches which often assume that local data samples are identically distributed. Federated learning enables multiple actors to build a common, robust machine learning model without sharing data, thus allowing to address critical issues such as data privacy, data security, data access rights and access to heterogeneous data.
[0122] In examples, the Al model may be trained continuously or periodically prior to performance of the inference operation by the processor 1608. Then, during the inference operation, the patient specific input features provided to the Al model may be propagated from an input layer, through one or more hidden layers, and ultimately to an output layer that corresponds to the suggested medical procedure. For example, if the age of the patient, size of the patient, or any other medical information of the patient, and the medical information, such as, the location of the patient indicate the sample may be difficult to obtain, the processor 1608 can suggest a smaller version of the endoscope, suggest a different path that can maximize imaging and sampling efforts, or suggest a maximum energy used for any cutting, ablation, or removal procedures.
[0123] During and / or subsequent to the inference operation, the output interface 1610 can transmit any of the safest and most efficient medical procedure may be communicated to the user via the user interface (UI) and / or automatically cause any component of the endoscopic system for performing a desired action. For example, if the imaging quality is poor, the processor 1608 can transmit a signal to the light source control unit to alter the brightness, color, saturation, or any other light parameter, of the light transmitted, send a controlling signal to the fluid source to change a fluid supplied to the pump(s), send a signal to the pump(s) to alter a velocity or volume of fluid supplied to the imaging site, send a signal to the pump(s) to increase or decrease an amount of suction provided to the imaging site. These are exemplary actions that can be taken by the CDSS 1600 to aid in the instruction and procedure of the medical procedure. However, the inventors of the present application have contemplated how the CDSS 1600 can help with any aspect of the medical procedure, such as, planning preoperatively, performing intraoperatively, or analyzing the procedure postoperatively, or the like.
[0124] FIG. 17 illustrates a block diagram of an example machine 1700 upon which any one or more of the techniques (e.g., methodologies) discussed herein may be implemented. Examples, as described herein, may include, or may operate by, logic orDocket No. 5409.875WO1 a number of components, or mechanisms in the machine 1700. Circuitry (e.g., processing circuitry) is a collection of circuits implemented in tangible entities of the machine 1700 that include hardware (e.g., simple circuits, gates, logic, etc.). Circuitry membership may be flexible over time. Circuitries include members that may, alone or in combination, perform specified operations when operating. In an example, hardware of the circuitry may be immutably designed to carry out a specific operation (e.g., hardwired). In an example, the hardware of the circuitry may include variably connected physical components (e.g., execution units, transistors, simple circuits, etc.) including a machine readable medium physically modified (e.g., magnetically, electrically, moveable placement of invariant massed particles, etc.) to encode instructions of the specific operation. In connecting the physical components, the underlying electrical properties of a hardware constituent are changed, for example, from an insulator to a conductor or vice versa. The instructions enable embedded hardware (e.g., the execution units or a loading mechanism) to create members of the circuitry in hardware via the variable connections to carry out portions of the specific operation when in operation. Accordingly, in an example, the machine readable medium elements are part of the circuitry or are communicatively coupled to the other components of the circuitry when the device is operating. In an example, any of the physical components may be used in more than one member of more than one circuitry. For example, under operation, execution units may be used in a first circuit of a first circuitry at one point in time and reused by a second circuit in the first circuitry, or by a third circuit in a second circuitry at a different time. Additional examples of these components with respect to the machine 1700 follow.
[0125] In alternative examples, the machine 1300 may operate as a standalone device or may be connected (e.g., networked) to other machines. In a networked deployment, the machine 1700 may operate in the capacity of a server machine, a client machine, or both in server-client network environments. In an example, the machine 1700 may act as a peer machine in peer-to-peer (P2P) (or other distributed) network environment. The machine 1700 may be a personal computer (PC), a tablet PC, a set- top box (STB), a personal digital assistant (PDA), a mobile telephone, a web appliance, a network router, switch or bridge, or any machine capable of executing instructions (sequential or otherwise) that specify actions to be taken by that machine. Further, while only a single machine is illustrated, the term “machine” shall also be taken to include any collection of machines that individually or jointly execute a set (or multiple sets) ofDocket No. 5409.875WO1 instructions to perform any one or more of the methodologies discussed herein, such as cloud computing, software as a service (SaaS), other computer cluster configurations.
[0126] The machine 1700 may include a hardware processor 1702 (e.g., a central processing unit (CPU), a graphics processing unit (GPU), a hardware processor core, or any combination thereof), a main memory 1704, a static memory (e.g., memory or storage for firmware, microcode, a basic-input-output (BIOS), and mass storage 1708 (e.g., hard drives, tape drives, flash storage, or other block devices) some or all of which may communicate with each other via an interlink 1730 (e.g., bus). The machine 1700 may further include a display unit 1710, an alphanumeric input device 1712 (e.g., a keyboard), and a user interface (UI) navigation device 1714 (e.g., a mouse). In an example, the display unit 1710, input device 1712 and UI navigation device 1714 may be a touch screen display. The machine 1700 may additionally include a signal generation device 1718 (e.g., a speaker), a network interface device 1720, and one or more sensors 1716, such as a global positioning system (GPS) sensor, compass, accelerometer, or other sensor. The machine 1700 may include an output controller 1728, such as a serial (e.g., universal serial bus (USB), parallel, or other wired or wireless (e.g., infrared (IR), near field communication (NFC), etc.) connection to communicate or control one or more peripheral devices (e.g., a printer, card reader, etc.).
[0127] Registers of the processor 1702, the main memory 1704, the static memory 1706, or the mass storage 1708 may be, or include, a machine readable medium 1722 on which is stored one or more sets of data structures or instructions 1724 (e.g., software) embodying or utilized by any one or more of the techniques or functions described herein. The instructions 1724 may also reside, completely or at least partially, within any of registers of the processor 1702, the main memory 1704, the static memory 1706, or the mass storage 1708 during execution thereof by the machine 1700. In an example, one or any combination of the hardware processor 1702, the main memory 1704, the static memory 1706, or the mass storage 1708 may constitute the machine readable media 1722. While the machine readable medium 1722 is illustrated as a single medium, the term “machine readable medium” may include a single medium or multiple media (e.g., a centralized or distributed database, and / or associated caches and servers) configured to store the one or more instructions 1724.
[0128] The term “machine readable medium” may include any medium that is capable of storing, encoding, or carrying instructions for execution by the machine 1700 and that cause the machine 1700 to perform any one or more of the techniques of theDocket No. 5409.875WO1 present disclosure, or that is capable of storing, encoding or carrying data structures used by or associated with such instructions. Non-limiting machine readable medium examples may include solid-state memories, optical media, magnetic media, and signals (e.g., radio frequency signals, other photon based signals, sound signals, etc.). In an example, a non-transitory machine readable medium comprises a machine readable medium with a plurality of particles having invariant (e.g., rest) mass, and thus are compositions of matter. Accordingly, non-transitory machine-readable media are machine readable media that do not include transitory propagating signals. Specific examples of non-transitory machine readable media may include: non-volatile memory, such as semiconductor memory devices (e.g., Electrically Programmable Read-Only Memory (EPROM), Electrically Erasable Programmable Read-Only Memory (EEPROM)) and flash memory devices; magnetic disks, such as internal hard disks and removable disks; magneto-optical disks; and CD-ROM and DVD-ROM disks.
[0129] In an example, information stored or otherwise provided on the machine readable medium 1722 may be representative of the instructions 1724, such as instructions 1724 themselves or a format from which the instructions 1724 may be derived. This format from which the instructions 1724 may be derived may include source code, encoded instructions (e.g., in compressed or encrypted form), packaged instructions (e.g., split into multiple packages), or the like. The information representative of the instructions 1724 in the machine readable medium 1722 may be processed by processing circuitry into the instructions to implement any of the operations discussed herein. For example, deriving the instructions 1724 from the information (e.g., processing by the processing circuitry) may include: compiling (e.g., from source code, object code, etc.), interpreting, loading, organizing (e.g., dynamically or statically linking), encoding, decoding, encrypting, unencrypting, packaging, unpackaging, or otherwise manipulating the information into the instructions 1724.
[0130] In an example, the derivation of the instructions 1324 may include assembly, compilation, or interpretation of the information (e.g., by the processing circuitry) to create the instructions 1324 from some intermediate or preprocessed format provided by the machine readable medium 1322. The information, when provided in multiple parts, may be combined, unpacked, and modified to create the instructions 1324. For example, the information may be in multiple compressed source code packages (or object code, or binary executable code, etc.) on one or several remote servers. The source code packages may be encrypted when in transit over a network andDocket No. 5409.875WO1 decrypted, uncompressed, assembled (e.g., linked) if necessary, and compiled or interpreted (e.g., into a library, stand-alone executable etc.) at a local machine, and executed by the local machine.
[0131] The instructions 1724 may be further transmitted or received over a communications network 1726 using a transmission medium via the network interface device 1720 utilizing any one of a number of transfer protocols (e.g., frame relay, internet protocol (IP), transmission control protocol (TCP), user datagram protocol (UDP), hypertext transfer protocol (HTTP), etc.). Example communication networks may include a local area network (LAN), a wide area network (WAN), a packet data network (e.g., the Internet), LoRa / LoRaWAN, or satellite communication networks, mobile telephone networks (e.g., cellular networks such as those complying with 3G, 4G LTE / LTE-A, or 5G standards), Plain Old Telephone (POTS) networks, and wireless data networks (e.g., Institute of Electrical and Electronics Engineers (IEEE) 802.11 family of standards known as Wi-Fi®, IEEE 802.15.4 family of standards, peer-to-peer (P2P) networks, among others. In an example, the network interface device 1720 may include one or more physical jacks (e.g., Ethernet, coaxial, or phone jacks) or one or more antennas to connect to the communications network 1726. In an example, the network interface device 1720 may include a plurality of antennas to wirelessly communicate using at least one of single-input multiple-output (SIMO), multiple-input multiple-output (MIMO), or multiple-input single-output (MISO) techniques. The term “transmission medium” shall be taken to include any intangible medium that is capable of storing, encoding or carrying instructions for execution by the machine 1700, and includes digital or analog communications signals or other intangible medium to facilitate communication of such software. A transmission medium is a machine- readable medium.
[0132] The following, non-limiting examples, detail certain aspects of the present subject matter to solve the challenges and provide the benefits discussed herein, among others.
[0133] Examples:
[0134] Example 1 is a method for verifying an operation of an endoscopically- associated optical sensor, the method comprising: activating a light source to emit a first optical signal having a specified spectrum; measuring, using the optical sensor, a first spectrum corresponding to the first optical signal; and comparing the first spectrum to aDocket No. 5409.875WO1 reference spectrum to determine whether the optical sensor is operating within a specified tolerance.
[0135] In Example 2, the subject matter of Example 1 optionally includes wherein the method comprises: activating the light source to emit a second optical signal having the specified spectrum, wherein the second optical signal has a different intensity of light than an intensity of light in the first optical signal; measuring, using the optical sensor, a second spectrum corresponding to the second optical signal; determining an adjusted spectrum using the first spectrum and the second spectrum; and wherein comparing the first spectrum to the reference spectrum includes comparing the adjusted spectrum to the reference spectrum.
[0136] In Example 3, the subject matter of Example 2 optionally includes wherein measuring the second spectrum is performed within one second of measuring the first spectrum.
[0137] In Example 4, the subject matter of any one or more of Examples 2-3 optionally include wherein determining the adjusted spectrum includes subtracting the second spectrum from the first spectrum to remove a common mode between the first spectrum and the second spectrum.
[0138] In Example 5, the subject matter of any one or more of Examples 2-4 optionally include deactivating the light source such that the light source does not emit light and wherein the second spectrum represents a background spectrum.
[0139] In Example 6, the subject matter of any one or more of Examples 1-5 optionally include wherein the first spectrum and the reference spectrum include a measured intensity at a plurality of frequencies, and wherein comparing the first spectrum to the reference spectrum includes normalizing the first spectrum and normalizing the reference spectrum with respect to a specified average intensity across the plurality of frequencies and determining a deviation of normalized intensity between corresponding frequencies of the first spectrum and the reference spectrum.
[0140] In Example 7, the subject matter of Example 6 optionally includes wherein comparing the first spectrum to the reference spectrum includes determining an amount of the deviations of normalized intensity that are within a specified deviation threshold, wherein the optical sensor is deemed to be within the specified tolerance when the amount of deviations that are within the specified deviation threshold are below a specified threshold amount.Docket No. 5409.875WO1
[0141] In Example 8, the subject matter of any one or more of Examples 1-7 optionally include wherein comparing the first spectrum to the reference spectrum includes using a machine-learning model, the machine-learning model trained to recognize whether the optical sensor is operating within the specified tolerance.
[0142] In Example 9, the subject matter of any one or more of Examples 1-8 optionally include generating the reference spectrum following a calibration of the optical sensor, including: activating the light source to emit a third optical signal having the specified spectrum; and measuring, using the optical sensor in an environment with controlled ambient light, a third spectrum corresponding to the third optical signal, wherein the third spectrum is the reference spectrum.
[0143] In Example 10, the subject matter of any one or more of Examples 1-9 optionally include wherein the light source is an optical aiming beam used during an endoscopic medical procedure, and the method is performed before an optical fiber is coupled to the light source.
[0144] In Example 11, the subject matter of any one or more of Examples 1-10 optionally include wherein measuring the first spectrum and comparing the first spectrum to a reference spectrum comprises a verification pass, wherein the method includes two or more verification passes.
[0145] In Example 12, the subject matter of Example 11 optionally includes wherein only one of the two or more verification passes must be within the specified tolerance for the optical sensor to be determined to be within the specified tolerance.
[0146] In Example 13, the subject matter of any one or more of Examples 1-12 optionally include wherein the optical sensor includes a spectroscope, wherein the spectroscope is included in combination with an endoscope system.
[0147] In Example 14, the subject matter of Example 13 optionally includes wherein the first spectrum is measured before an optical fiber or fiber bundle is coupled to the endoscope system.
[0148] In Example 15, the subject matter of any one or more of Examples 1-14 optionally include wherein the light source is an endoscopic light source used during an endoscopic medical procedure, and the method is performed after an optical fiber is coupled to the light source.
[0149] Example 16 is a medical device system for verifying an operation of an endoscopically associated optical sensor during an endoscopic medical procedure, the medical device system comprising: the optical sensor, configured to measure a firstDocket No. 5409.875WO1 spectrum corresponding to a light source having a specified spectrum; and processor circuitry, configured to retrieve a reference spectrum associated with the light source and compare the first spectrum to the retrieved reference spectrum to determine whether the optical sensor is operating within a specified tolerance.
[0150] In Example 17, the subject matter of Example 16 optionally includes the light source, wherein the light source is an optical aiming beam used during the endoscopic medical procedure.
[0151] In Example 18, the subject matter of any one or more of Examples 16-17 optionally include a shield, configured to block ambient light from the optical sensor during verification, wherein the shield is configured to be connected in place of an optical fiber or optical fiber bundle.
[0152] Example 19 is a medical device system for verifying an operation of an endoscopically-associated optical sensor, the medical device system comprising: a processor; and a memory storing instructions that, when executed by the processor, configure the medical device system to: activate a light source to emit a first optical signal having a specified spectrum; measure, using the optical sensor, a first spectrum corresponding to the first optical signal; and compare the first spectrum to a reference spectrum to determine whether the optical sensor is operating within a specified tolerance.
[0153] In Example 20, the subject matter of Example 19 optionally includes wherein the memory stores further instructions to configure the medical device system to: activate the light source to emit a second optical signal having the specified spectrum, wherein the second optical signal has a different intensity of light than an intensity of light in the first optical signal; measure, using the optical sensor, a second spectrum corresponding to the second optical signal; determine an adjusted spectrum using the first spectrum and the second spectrum; and wherein comparing the first spectrum to the reference spectrum includes comparing the adjusted spectrum to the reference spectrum.
[0154] In Example 21, the subject matter of Example 20 optionally includes wherein the second spectrum is measured within one second of measuring the first spectrum.
[0155] In Example 22, the subject matter of any one or more of Examples 20-21 optionally include wherein to determine the adjusted spectrum includes to subtract the second spectrum from the first spectrum to remove a common mode between the first spectrum and the second spectrum.Docket No. 5409.875WO1
[0156] In Example 23, the subject matter of any one or more of Examples 20-22 optionally include wherein the memory stores further instructions to configure the medical device system to: deactivate the light source such that the light source does not emit light, wherein the second spectrum represents a background spectrum.
[0157] In Example 24, the subject matter of any one or more of Examples 19-23 optionally include wherein the first spectrum and the reference spectrum include a measured intensity at a plurality of frequencies, and wherein comparing the first spectrum to the reference spectrum includes normalizing the first spectrum and normalizing the reference spectrum with respect to a specified average intensity across the plurality of frequencies and determining a deviation of normalized intensity between corresponding frequencies of the first spectrum and the reference spectrum.
[0158] In Example 25, the subject matter of Example 24 optionally includes wherein comparing the first spectrum to the reference spectrum includes determining an amount of the deviations of normalized intensity that are within a specified deviation threshold, wherein the optical sensor is deemed to be within the specified tolerance when the amount of deviations that are within the specified deviation threshold are below a specified threshold amount.
[0159] In Example 26, the subject matter of any one or more of Examples 19-25 optionally include wherein comparing the first spectrum to the reference spectrum includes using a machine-learning model, the machine-learning model trained to recognize whether the optical sensor is operating within the specified tolerance.
[0160] In Example 27, the subject matter of any one or more of Examples 19-26 optionally include wherein the memory stores further instructions to configure the medical device system to: generate the reference spectrum following a calibration of the optical sensor, including to: activate the light source to emit a third optical signal having the specified spectrum; and measure, using the optical sensor in an environment with controlled ambient light, a third spectrum corresponding to the third optical signal, wherein the third spectrum is the reference spectrum.
[0161] In Example 28, the subject matter of any one or more of Examples 19-27 optionally include wherein the light source is an optical aiming beam optical during an endoscopic medical procedure, and the light source is activated before an optical fiber is coupled to the light source.
[0162] In Example 29, the subject matter of any one or more of Examples 19-28 optionally include wherein measuring the first spectrum and comparing the firstDocket No. 5409.875WO1 spectrum to a reference spectrum comprises a verification pass, wherein the memory stores further instructions to configure the medical device system to perform two or more verification passes.
[0163] In Example 30, the subject matter of Example 29 optionally includes wherein only one of the two or more verification passes must be within the specified tolerance for the optical sensor to be determined to be within the specified tolerance.
[0164] In Example 31, the subject matter of any one or more of Examples 19-30 optionally include wherein the optical sensor includes a spectroscope, wherein the spectroscope is included in combination with an endoscope system.
[0165] In Example 32, the subject matter of Example 31 optionally includes wherein the first spectrum is measured before an optical fiber or fiber bundle is coupled to the endoscope system.
[0166] In Example 33, the subject matter of any one or more of Examples 19-32 optionally include wherein the light source is an endoscopic light source used during an endoscopic medical procedure, and the first spectrum is measured after an optical fiber is coupled to the light source.
[0167] Example 34 is at least one machine-readable medium including instructions that, when executed by processing circuitry, cause the processing circuitry to perform operations to implement of any of Examples 1-33.
[0168] Example 35 is an apparatus comprising means to implement of any of Examples 1-33.
[0169] Example 36 is a system to implement of any of Examples 1-33.
[0170] Example 37 is a method to implement of any of Examples 1-33.
[0171] Each of the non-limiting aspects above can stand on its own or can be combined in various permutations or combinations with one or more of the other aspects or other subject matter described in this document.
[0172] The above detailed description includes references to the accompanying drawings, which form a part of the detailed description. The drawings show, by way of illustration, specific examples that may be practiced. These embodiments are also referred to herein as “examples.” Such examples may include elements in addition to those shown or described. However, the present inventors also contemplate examples in which only those elements shown or described are provided. Moreover, the present inventors also contemplate examples using any combination or permutation of thoseDocket No. 5409.875WO1 elements shown or described (or one or more aspects thereof), either with respect to a particular example (or one or more aspects thereof), or with respect to other examples (or one or more aspects thereof) shown or described herein.
[0173] All publications, patents, and patent documents referred to in this document are incorporated by reference herein in their entirety, as though individually incorporated by reference. In the event of inconsistent usages between this document and those documents so incorporated by reference, the usage in the incorporated reference(s) should be considered supplementary to that of this document; for irreconcilable inconsistencies, the usage in this document controls.
[0174] In this document, the terms “a” or “an” are used, as is common in patent documents, to include one or more than one, independent of any other instances or usages of “at least one” or “one or more.” In this document, the term “or” is used to refer to a nonexclusive or, such that “A or B” includes “A but not B,” “B but not A,” and “A and B,” unless otherwise indicated. In the appended claims, the terms “including” and “in which” are used as the plain-English equivalents of the respective terms “comprising” and “wherein.” Also, in the following claims, the terms “including” and “comprising” are open-ended, that is, a system, device, article, or process that includes elements in addition to those listed after such a term in a claim are still deemed to fall within the scope of that claim. Moreover, in the following claims, the terms “first,” “second,” and “third,” etc. are used merely as labels, and are not intended to impose numerical requirements on their objects.
[0175] The term “about,” as used herein, means approximately, in the region of, roughly, or around. When the term “about” is used in conjunction with a numerical range, it modifies that range by extending the boundaries above and below the numerical values set forth. In general, the term “about” is used herein to modify a numerical value above and below the stated value by a variance of 10%. In one aspect, the term “about” means plus or minus 10% of the numerical value of the number with which it is being used. Therefore, about 50% means in the range of 45%-55%. Numerical ranges recited herein by endpoints include all numbers and fractions subsumed within that range (e.g., 1 to 5 includes 1, 1.5, 2, 2.75, 3, 3.90, 4, 4.24, and 5). Similarly, numerical ranges recited herein by endpoints include subranges subsumed within that range (e.g., 1 to 5 includes 1-1.5, 1.5-2, 2-2.75, 2.75-3, 3-3.90, 3.90-4, 4-4.24, 4.24-5, 2-5, 3-5, 1-4, and 2-4). It isDocket No. 5409.875WO1 also to be understood that all numbers and fractions thereof are presumed to be modified by the term “about.”
[0176] Method examples described herein can be machine or computer- implemented at least in part. Some examples can include a computer-readable medium or machine-readable medium encoded with instructions operable to configure an electronic device to perform methods as described in the above examples. An implementation of such methods can include code, such as microcode, assembly language code, a higher-level language code, or the like. Such code can include computer readable instructions for performing various methods. The code may form portions of computer program products. Such instructions can be read and executed by one or more processors to enable performance of operations comprising a method, for example. The instructions are in any suitable form, such as but not limited to source code, compiled code, interpreted code, executable code, static code, dynamic code, and the like.
[0177] Further, in an example, the code can be tangibly stored on one or more volatile, non-transitory, or non-volatile tangible computer-readable media, such as during execution or at other times. Examples of these tangible computer-readable media can include, but are not limited to, hard disks, removable magnetic disks, removable optical disks (e.g., compact disks and digital video disks), magnetic cassettes, memory cards or sticks, random access memories (RAMs), read only memories (ROMs), and the like.
[0178] The above description is intended to be illustrative, and not restrictive. For example, the above-described examples (or one or more aspects thereof) may be used in combination with each other. Other examples may be used, such as by one of ordinary skill in the art upon reviewing the above description. The Abstract is to allow the reader to quickly ascertain the nature of the technical disclosure and is submitted with the understanding that it will not be used to interpret or limit the scope or meaning of the claims. Also, in the above Detailed Description, various features may be grouped together to streamline the disclosure. This should not be interpreted as intending that an unclaimed disclosed feature is essential to any claim. Rather, inventive subject matter may lie in less than all features of a particular disclosed embodiment. Thus, the following claims are hereby incorporated into the Detailed Description, with each claim standing on its own as a separate embodiment. The scope of the examples should be determined with reference to the appended claims, along with the full scope of equivalents to which such claims are entitled.
Claims
Docket No. 5409.875WO1CLAIMSWhat is claimed is:
1. A method for verifying an operation of an endoscopically-associated optical sensor, the method comprising: activating a light source to emit a first optical signal having a specified spectrum; measuring, using the optical sensor, a first spectrum corresponding to the first optical signal; and comparing the first spectrum to a reference spectrum to determine whether the optical sensor is operating within a specified tolerance.
2. The method of claim 1, wherein the method comprises: activating the light source to emit a second optical signal having the specified spectrum, wherein the second optical signal has a different intensity of light than an intensity of light in the first optical signal; measuring, using the optical sensor, a second spectrum corresponding to the second optical signal; determining an adjusted spectrum using the first spectrum and the second spectrum; and wherein comparing the first spectrum to the reference spectrum includes comparing the adjusted spectrum to the reference spectrum.
3. The method of claim 2, wherein measuring the second spectrum is performed within one second of measuring the first spectrum.
4. The method of claim 2, wherein determining the adjusted spectrum includes subtracting the second spectrum from the first spectrum to remove a common mode between the first spectrum and the second spectrum.
5. The method of claim 2, deactivating the light source such that the light source does not emit light and wherein the second spectrum represents a background spectrum.
6. The method of claim 1, wherein the first spectrum and the reference spectrum include a measured intensity at a plurality of frequencies, and wherein comparing the first spectrum to the reference spectrum includes normalizing the first spectrumDocket No. 5409.875WO1 and normalizing the reference spectrum with respect to a specified average intensity across the plurality of frequencies and determining a deviation of normalized intensity between corresponding frequencies of the first spectrum and the reference spectrum.
7. The method of claim 6, wherein comparing the first spectrum to the reference spectrum includes determining an amount of the deviations of normalized intensity that are within a specified deviation threshold, wherein the optical sensor is deemed to be within the specified tolerance when the amount of deviations that are within the specified deviation threshold are below a specified threshold amount.
8. The method of claim 1, wherein comparing the first spectrum to the reference spectrum includes using a machine-learning model, the machine-learning model trained to recognize whether the optical sensor is operating within the specified tolerance.
9. The method of claim 1, further comprising: generating the reference spectrum following a calibration of the optical sensor, including: activating the light source to emit a third optical signal having the specified spectrum; and measuring, using the optical sensor in an environment with controlled ambient light, a third spectrum corresponding to the third optical signal, wherein the third spectrum is the reference spectrum.
10. The method of claim 1, wherein the light source is an optical aiming beam used during an endoscopic medical procedure, and the method is performed before an optical fiber is coupled to the light source.
11. The method of claim 1, wherein measuring the first spectrum and comparing the first spectrum to a reference spectrum comprises a verification pass, wherein the method includes two or more verification passes.
12. The method of claim 11, wherein only one of the two or more verification passes must be within the specified tolerance for the optical sensor to be determined to be within the specified tolerance.Docket No. 5409.875WO113. The method of claim 1, wherein the optical sensor includes a spectroscope, wherein the spectroscope is included in combination with an endoscope system.
14. The method of claim 13, wherein the first spectrum is measured before an optical fiber or fiber bundle is coupled to the endoscope system.
15. The method of claim 1, wherein the light source is an endoscopic light source used during an endoscopic medical procedure, and the method is performed after an optical fiber is coupled to the light source.
16. A medical device system for verifying an operation of an endoscopically associated optical sensor during an endoscopic medical procedure, the medical device system comprising: the optical sensor, configured to measure a first spectrum corresponding to a light source having a specified spectrum; and processor circuitry, configured to retrieve a reference spectrum associated with the light source and compare the first spectrum to the retrieved reference spectrum to determine whether the optical sensor is operating within a specified tolerance.
17. The medical device system of claim 16, further comprising the light source, wherein the light source is an optical aiming beam used during the endoscopic medical procedure.
18. The medical device system of claim 16, further comprising a shield, configured to block ambient light from the optical sensor during verification, wherein the shield is configured to be connected in place of an optical fiber or optical fiber bundle.
19. A medical device system for verifying an operation of an endoscopically- associated optical sensor, the medical device system comprising: a processor; and a memory storing instructions that, when executed by the processor, configure the medical device system to: activate a light source to emit a first optical signal having a specified spectrum;Docket No. 5409.875WO1 measure, using the optical sensor, a first spectrum corresponding to the first optical signal; and compare the first spectrum to a reference spectrum to determine whether the optical sensor is operating within a specified tolerance.
20. The medical device system of claim 19, wherein the memory stores further instructions to configure the medical device system to: activate the light source to emit a second optical signal having the specified spectrum, wherein the second optical signal has a different intensity of light than an intensity of light in the first optical signal; measure, using the optical sensor, a second spectrum corresponding to the second optical signal; determine an adjusted spectrum using the first spectrum and the second spectrum; and wherein comparing the first spectrum to the reference spectrum includes comparing the adjusted spectrum to the reference spectrum.
21. The medical device system of claim 20, wherein the second spectrum is measured within one second of measuring the first spectrum.
22. The medical device system of claim 20, wherein to determine the adjusted spectrum includes to subtract the second spectrum from the first spectrum to remove a common mode between the first spectrum and the second spectrum.
23. The medical device system of claim 20, wherein the memory stores further instructions to configure the medical device system to: deactivate the light source such that the light source does not emit light, wherein the second spectrum represents a background spectrum.
24. The medical device system of claim 19, wherein the first spectrum and the reference spectrum include a measured intensity at a plurality of frequencies, and wherein comparing the first spectrum to the reference spectrum includes normalizing the first spectrum and normalizing the reference spectrum with respect to a specified average intensity across the plurality of frequencies and determining a deviation of normalized intensity between corresponding frequencies of the first spectrum and the reference spectrum.Docket No. 5409.875WO125. The medical device system of claim 24, wherein comparing the first spectrum to the reference spectrum includes determining an amount of the deviations of normalized intensity that are within a specified deviation threshold, wherein the optical sensor is deemed to be within the specified tolerance when the amount of deviations that are within the specified deviation threshold are below a specified threshold amount.
26. The medical device system of claim 19, wherein comparing the first spectrum to the reference spectrum includes using a machine-learning model, the machinelearning model trained to recognize whether the optical sensor is operating within the specified tolerance.
27. The medical device system of claim 19, wherein the memory stores further instructions to configure the medical device system to: generate the reference spectrum following a calibration of the optical sensor, including to: activate the light source to emit a third optical signal having the specified spectrum; and measure, using the optical sensor in an environment with controlled ambient light, a third spectrum corresponding to the third optical signal, wherein the third spectrum is the reference spectrum.
28. The medical device system of claim 19, wherein the light source is an optical aiming beam optical during an endoscopic medical procedure, and the light source is activated before an optical fiber is coupled to the light source.
29. The medical device system of claim 19, wherein measuring the first spectrum and comparing the first spectrum to a reference spectrum comprises a verification pass, wherein the memory stores further instructions to configure the medical device system to perform two or more verification passes.
30. The medical device system of claim 29, wherein only one of the two or more verification passes must be within the specified tolerance for the optical sensor to be determined to be within the specified tolerance.Docket No. 5409.875WO131. The medical device system of claim 19, wherein the optical sensor includes a spectroscope, wherein the spectroscope is included in combination with an endoscope system.
32. The medical device system of claim 31, wherein the first spectrum is measured before an optical fiber or fiber bundle is coupled to the endoscope system.
33. The medical device system of claim 19, wherein the light source is an endoscopic light source used during an endoscopic medical procedure, and the first spectrum is measured after an optical fiber is coupled to the light source.
Citation Information
Patent Citations
Target identification with optical feedback signal splitter
US20210038300A1
Raman spectroscopy system, apparatus, and method for analyzing, characterizing, and / or diagnosing a type or nature of a sample or a tissue such as an abnormal growth
US20170138860A1
System and method for improving calibration transfer between multiple raman analyzer installations
US20220018780A1
System and method for fault detection and operational readiness for optical instruments for semiconductor processes
US20240019305A1
US202463696448P