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WO2025144715A1 - Systèmes et procédés de commande de traitements laser utilisant des signaux d'intensité réfléchis - Google Patents

Systèmes et procédés de commande de traitements laser utilisant des signaux d'intensité réfléchis Download PDF

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Publication number
WO2025144715A1
WO2025144715A1 PCT/US2024/061303 US2024061303W WO2025144715A1 WO 2025144715 A1 WO2025144715 A1 WO 2025144715A1 US 2024061303 W US2024061303 W US 2024061303W WO 2025144715 A1 WO2025144715 A1 WO 2025144715A1
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WIPO (PCT)
Prior art keywords
target
treatment
laser
surgical
ratio
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PCT/US2024/061303
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English (en)
Inventor
Gregorg ALTSHULER
Dmitriy NIKITIN
Daniil MYASNIKOV
Anastasiya KOVALENKO
Viacheslav Brunov
Dmitriy PROTASENYA
Andrey Mashkin
Ilya Yaroslavsky
Dmitri Boutoussov
Dilip PAINTHANKAR
Mikhail Kaluzhny
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IPG Photonics Corp
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IPG Photonics Corp
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Publication of WO2025144715A1 publication Critical patent/WO2025144715A1/fr
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    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B18/18—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by applying electromagnetic radiation, e.g. microwaves
    • A61B18/20—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by applying electromagnetic radiation, e.g. microwaves using laser
    • A61B18/22—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by applying electromagnetic radiation, e.g. microwaves using laser the beam being directed along or through a flexible conduit, e.g. an optical fibre; Couplings or hand-pieces therefor
    • A61B18/26—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by applying electromagnetic radiation, e.g. microwaves using laser the beam being directed along or through a flexible conduit, e.g. an optical fibre; Couplings or hand-pieces therefor for producing a shock wave, e.g. laser lithotripsy
    • G—PHYSICS
    • G16—INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR SPECIFIC APPLICATION FIELDS
    • G16H—HEALTHCARE INFORMATICS, i.e. INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR THE HANDLING OR PROCESSING OF MEDICAL OR HEALTHCARE DATA
    • G16H20/00—ICT specially adapted for therapies or health-improving plans, e.g. for handling prescriptions, for steering therapy or for monitoring patient compliance
    • G16H20/40—ICT specially adapted for therapies or health-improving plans, e.g. for handling prescriptions, for steering therapy or for monitoring patient compliance relating to mechanical, radiation or invasive therapies, e.g. surgery, laser therapy, dialysis or acupuncture
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    • A61B2018/00982—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body combined with or comprising means for visual or photographic inspections inside the body, e.g. endoscopes
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    • A61B2018/00988—Means for storing information, e.g. calibration constants, or for preventing excessive use, e.g. usage, service life counter
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    • A61B90/06—Measuring instruments not otherwise provided for
    • A61B2090/061—Measuring instruments not otherwise provided for for measuring dimensions, e.g. length

Definitions

  • Directed energy e.g., electromagnetic including optical, mechanical, acoustic including ultrasound, etc.
  • U stone disease including kidney and bladder stone
  • kidney and bladder stone which is estimated to affect 12% of the world population. While most patients with kidney stone disease can pass stones naturally, severe cases of kidney stone disease (e.g., in which the patient cannot pass the kidney stone) require medical intervention including use of directed energy. If severe cases of kidney stone disease are left untreated, extreme pain, nausea, vomiting, infection, blockage of urine flow, and loss of kidney function can soon follow.
  • Laser lithotripsy is one method of using directed energy to treat urinary stones, which uses directed laser energy, delivered via a fiber, to target the stone.
  • Laser lithotripsy can be advantageous to other forms of directed energy (e g., ultrasound) because laser light, during laser lithotripsy, can be delivered by a fiber, which is flexible enough to curve and traverse different hard-to-reach structures.
  • the small outer diameter of the fiber allows its insertion into the working channels of most surgical instruments, including practically all scopes (rigid, semi-rigid, and flexible) used in urology.
  • a laser lithotripsy directed light energy from the laser is delivered to the stone, which breaks the stone into either finer particles that can be passed naturally, or bigger fragments that can be removed using auxiliary tools (e.g., baskets).
  • auxiliary tools e.g., baskets
  • the bigger fragments can be aspirated through a working channel of a scope (e.g., an endoscope).
  • a practitioner e.g., a doctor or surgeon
  • the computing device is further configured to generate an audio, visual, or tactile signal to an operator based on the identification of the target.
  • the treatment target is a stone and the non-treatment target is tissue or a surgical component or a surgical treatment area medium.
  • the method further includes positioning the distal end of the surgical fiber in quasi-contact with the stone, activating the treatment laser source so as to deliver laser radiation through the surgical fiber, and ablating at least a portion of the stone using the laser radiation.
  • the computing device is configured to couple with three photodetectors and the three different selected wavelength bands are selected from a group consisting of: about 400-410 nm, about 440-480 nm, about 460-480 nm, about 510-530 nm, about 540-560 nm, about 550-570 nm, about 570-580 nm, about 580-600 nm, about 600-620 nm, about 690-710 nm, about 740-760 nm, about 790-810 nm, about 920-940 nm, about 970- 990 nm, and about 1150-1350 nm.
  • the computing device is further configured to identify the target as a treatment target or a non-treatment target based at least in part on a comparison against stored data from previously recorded reflected intensity values.
  • the computing device is further configured to identify the target as a treatment target or a non-treatment target based at least in part on a machine learning model.
  • the computing device is further configured to identify the target as a treatment target or a non-treatment target based at least in part on a mathematical algorithm derived at least in part from at least one ratio of a reflected light intensity of one selected wavelength band to a reflected light intensity of a different selected wavelength band.
  • a surgical laser system that includes a surgical fiber configured to receive light reflected by a target in a surgical treatment area and deliver laser radiation from a treatment laser source to a treatment target, and a computing device configured to couple with at least two photodetectors, each photodetector configured to detect an intensity of reflected light from the target in a different selected wavelength band, and configured to: receive the reflected light intensity in at least two selected wavelength bands, generate optical data corresponding to the reflected light intensity, and identify the target as the treatment target or a non-treatment target based at least in part on the optical data and a predetermined calibration based on at least one known target.
  • the surgical fiber is configured to deliver light from a source of light to the surgical treatment area.
  • the at least one known target is stone, tissue, a surgical components, or a surgical treatment area medium.
  • the computing device is further configured to perform at least a portion of the predetermined calibration.
  • at least one of generating the optical data and performing the predetermined calibration includes determining at least one ratio of a reflected light intensity of one selected wavelength band to a reflected light intensity of a different selected wavelength band.
  • performing the predetermined calibration further comprises: receiving multiple reflected light intensity values from each known target of the at least one known target, and establishing a threshold ratio value based at least in part on the multiple reflected light intensity values from each known target.
  • the computing device is further configured to: generate at least one frequency distribution of values for each ratio of the at least one ratio, and determine the ratio value associated with the predetermined percentile for each known target based on the frequency distribution.
  • generating the optical data includes determining the at least one ratio for the target in the surgical treatment area, and identifying the target comprises: comparing a ratio value of the at least one ratio for the target in the surgical treatment area to the threshold ratio value, and determining whether the target in the surgical treatment area is a treatment target based on the comparison.
  • the computing device is configured such that: in response to a determination that the target in the surgical treatment area is a treatment target, identifying the target as a treatment target, or in response to a determination that the target in the surgical treatment area is not a treatment target, identifying the target as a non-treatment target.
  • the computing device is configured to determine whether the target in the surgical treatment area is a treatment target is performed in between every N pulses emitted by the treatment laser source, wherein N is an integer between 1 and 1000.
  • the computing device is further configured to determine whether the known target is a treatment target, and in response to a determination that the known target is a treatment target, identifying the target as a treatment target, or in response to a determination that the known target is not a treatment target, identifying the target as a nontreatment target.
  • Non-limiting examples disclosed herein may be combined with other non-limiting examples, and references to “an non-limiting example,” “an example,” “some non-limiting examples,” “some examples,” “an alternate non-limiting example,” “various non-limiting examples,” “one non-limiting example,” “at least one nonlimiting example,” “this and other non-limiting examples,” “certain non-limiting examples,” or the like are not necessarily mutually exclusive and are intended to indicate that a particular feature, structure, or characteristic described may be included in at least one non-limiting example. The appearances of such terms herein are not necessarily all referring to the same non-limiting example.
  • FIG. 1 is a schematic illustration of a non-limiting example of a smart laser system in accordance with aspects of the present disclosure.
  • FIG. 2 is a schematic illustration of an integrated laser-surgical system with the smart laser system of FIG. 1 being implemented in a surgical environment.
  • FIG. 3 is a schematic illustration of the optical adapter of FIG. 2.
  • FIG. 4 is a schematic illustration of the non-limiting example of the smart laser system of FIG. 1, further illustrating additional or optional components of the system.
  • FIG. 5 is a schematic illustration of another laser system.
  • FIG. 5 also shows schematic representation of an optical adapter in accordance with aspects of the disclosure.
  • FIG. 6 is a cross-sectional view of the multicore fiber, and light(s) sources, light detector(s), that interact therewith.
  • FIG. 8B is a graph showing one example of an optical data profile for use in a laser treatment in accordance with the present disclosure.
  • FIG. 9 is a graph showing examples of reflection spectrum of LED for different treatment targets normalized to maximal level in accordance with aspects of the disclosure.
  • FIG. 10 is a graph showing examples of spectrums LED light reflected spectrum of LED non-normalized to spectra of LED for different targets in accordance with aspects of the disclosure.
  • FIG. 11 is a table of total (integrated) value of reflected light of LED in specific spectral ranges in signal for different targets in accordance with aspects of the disclosure.
  • FIG. 12 is a graph showing examples of spectrum of ratio of stone/tissue for different treatment targets in accordance with aspects of the disclosure.
  • FIG. 13 is a flowchart of a process for determining a distance between a distal end of a fiber and a treatment target.
  • FIG. 20 is a schematic illustration of a non-limiting example of a smart laser system in accordance with aspects of the present disclosure.
  • utilizing light from sources other than the treatment laser can be advantageous in that the light from the other sources does not undesirably interact with tissues, stones, etc.
  • the light can advantageously have a lower power than the power of the laser treatment light from the treatment laser.
  • the system 100 comprises a multi-functional optical adapter 105, a laser source 110 to generate treatment radiation, a laser driver 101, a control system 150 that includes a processor for performing smart functionality, and surgical optical fiber 145 which can be part of the laser system or as a separate device.
  • Laser driver 101 is a source of laser pumping current and voltage. For example, it can be the driver of a diode laser or a flash lamp. Diode lasers can be used for direct tissue treatment or for pumping solid-state or fiber lasers. Flash lamps can be used for pumping a solid state laser.
  • the laser source 110 generates laser radiation, which is delivered to the optical adapter 105 via optical fiber or free beam 140.
  • Certain electromagnetic signals are reflected or generated in response to excitation and can propagate through the surgical optical fiber 145 into the optical adapter 105, where they are further directed to particular sensors 120.
  • These electromagnetic signals can include probe signal data based off the source of probe signals, which can be directed into the sensors 120 (via the optical adapter 105).
  • a control system 150 receives the signals from the sensors 120 and performs an analysis which is then used by the control system 150 to control other components of the system, such as the laser driver 101 and laser source 110.
  • Laser sources 110 can be any laser with parameter(s) optimized for desired therapeutic effect and transmittive through surgical fiber 145.
  • the laser sources may have a wavelength in the range of 1.85 - 2.2 pm, a pulse energy 0.001 to 10 J, a peak power 0. 1 to 100 kW, and an average power 2 - 200 W.
  • the laser source can be Ho:YAG, Tm:YAG, Tm:YLF and other solid state lasers having such parameters and flash lamp or diode pumped.
  • a Tm fiber laser configured with a diode pump in free-running or Q-switch modes of operation. This laser can also be used for soft tissue procedures.
  • lasers with wavelengths of 400-600 nm can be used.
  • a diode laser for example, with a wavelength of 400-460 nm, or 780-1100 nm, or 1300-2100 nm, or second harmonic of Nd:YAG laser with a wavelength of 530 nm can be used. Such a laser can operate in continuous wave (CW) mode with a power of 10 - 300 W.
  • a diode or diode- pumped laser such as a fiber laser source, can also be preferable for some configurations.
  • the smart laser may be a part of an integrated treatment system (FIG. 2), which, in addition to the laser system 100 and surgical fiber 145, may include a scope (flexible, semi-flexible, or rigid) 167, an aspiration, irrigation or aspiration/irrigation sub-system 170, and an Artificial Intelligence (Al) - run control center 151.
  • the Al control center performs the initial processing of signals from imaging system 166 of the scope 167, the aspiration/irrigation sub-system 170, and implements synchronization with the laser system 110 and the laser driver 101 .
  • Scope 167 includes a handle, a rigid, semi-rigid, or flexible shaft 168 with imaging/video sensor 171 and illumination light sources like LED or lamp 169 (lamp with fiber delivery) with illumination emission from the distal end of the shaft.
  • Al-run control center 151 can be integrated with laser system controller 150, or may be a separate unit or integrated with scope imaging system 166 with initial processing and control of video sensor 171.
  • the smart laser may receive and process visual information received by the video camera of the scope 169. This information can be used stand-alone or in combination with other informational channels available to the system from sensors 120 (elastic scattering, fluorescence etc.) and information about laser parameters from controller 150.
  • This information can be used for detection and recognition of various treatment conditions such as: 1) detecting/distinguishing between soft tissue and stone, 2) recognition of stone type and stone substructure, 3) recognition of soft tissue type (e.g., capsule/adenomas tissue boundary, detecting/distinguishing a tumor and normal tissue), 4) the distance between tissue or stone and the fiber distal end, 5) tissue bleeding, 6) surgical field visualization quality which can be compromised by scattering of light on products of ablation, 7) stone retropulsion displacement, 8) popcoming performance, 9) distal tip damage or contamination, 10) flashing in treatment area, 11) treatment organ recognition.
  • the camera image can be further processed by the image processor 166 or the Al-run control center.
  • the image processing algorithm is developed, optimized and validated for each clinical embodiment using an analysis of the clinical endoscopic video imaging and machine-learning methodology.
  • Use of information from the imaging system of endoscope 166 will further increase the accuracy of measuring a distance to the target, differentiating between stones and soft tissues, and identifying a stone or tissue type
  • the LED spectrum will become available to the control center in real time.
  • Real time information from the imaging system 166 and from the sensor 120 can be combined and processed in the laser control system or Al-run control system in real time to increase accuracy and for redundancy purposes.
  • the distance between a stone or tissue and the distal end of the fiber can be measured by the back reflection signal of the endoscopic LED, or by processing the image of the endoscopic video system.
  • a command for enabling or disabling laser emission or changing one or more laser parameters in predefined ranges can be issued if both signals are in acceptable ranges.
  • the 1 st step is to obtain a signal from the surgical treatment environment 102 using surgical fiber 145 and sensors 120 or/and signals from endoscopic imaging system 166 and other devices such as irrigation/aspiration system 170.
  • the 2 nd step is to process this signal to provide information about the surgical treatment environment or surgical fiber and instruments in the surgical treatment environment.
  • Table 1 is a list of non-limiting examples of the types of features and functions provided by certain embodiments of the systems and methods.
  • FIG. 3 shows a schematic illustration of an optical adapter 105, which is one example of the optical components of the optical adapter 105 that can facilitate directing light to and from different ports.
  • the optical adapter 105 can include beamsplitters 214, 216, 218, 220, and lenses 222, 224.
  • Each of the beamsplitters 214, 216, 218, 220 can be positioned within the optical adapter 105 (e.g., the housing of the optical adapter 105) and each can be oriented in the same way (e.g., angled as illustrated in FIG. 3).
  • the angle between the axis of the laser beam and normal to the beamsplitter surface can be in the range 10 to 70 degrees, preferably for some applications, 30 to 50 degrees.
  • the number of beamsplitters can match the number of aligned ports of the optical adapter 105 (e.g., with the exception of the ports 162, 164).
  • all the beamsplitters 214, 216, 218, 220 are illustrated as being oriented in the same way, it should be appreciated that the beamsplitters 214, 216, 218, 220 can be oriented in different ways, with the directing of light between ports being changed by the orientation of the beamsplitter.
  • Each beamsplitter can have dielectric coatings with maximal transmission of the laser beam and optimal reflection in spectral ranges of the probing beam and back reflection signals associated with ports connected to that beamsplitter.
  • some ports can include a lens or sets of lenses to re-image the proximal end of the surgical fiber 159 onto the detector. As shown in FIG.
  • a beamsplitter 214 can be positioned between (and aligned with) ports 166, 174, another beamsplitter 216 can be positioned between (and aligned with) ports 168, 176, another beamsplitter 218 can be positioned between (and aligned with) ports 170, 178, further beamsplitter 220 can be positioned between (and aligned with) ports 172, 180, and each of the beamsplitters 214, 216, 218, 220 can be positioned between (and aligned with) the ports 162, 164.
  • Each of the beamsplitters 214, 216, 218, 220 can direct light into (and out of) respective ports 174, 176, 178, 180, and each is able to transmit laser light therethrough to the optical port 164 (and to the surgical fiber 145).
  • light can be emitted into the port 174, directed by the beamsplitter 214 through the optical port 164 and into the proximal end of the fiber 145, which can follow in the direction 226 (e.g., which can extend from the proximal end to the distal end of the fiber 145).
  • light that is directed into the distal end of the fiber 145 along the direction 228 can be emitted through the port 164, can pass through the lens 224, and can be directed by the beamsplitter 220 through the port 180.
  • the lens 222 can be in optical communication with the treatment laser, and can be positioned in front of the port 162 within the optical adapter 105 behind each of the beamsplitters 214, 216, 218, 220.
  • the lens 222 can be a collimating lens. In this way, laser light can be collimated after passing through the lens 222.
  • the lens 224 can be a focusing lens, which can focus light that passes through the focusing lens in the direction 226, and can diverge light that passes through the focusing lens in the direction 228.
  • the lens 224 can be positioned behind the port 164 and in front of each of the beamsplitters 214, 216, 218, 220 within the optical adapter 105.
  • FIG. 4 shows the schematic illustration of FIG. 1, but further includes an input device 262 and an output device 260. That is, the system described above with respect to FIG. 1 may be adapted to include a variety of user interfaces, such as a display that may form the output device 260 and a variety of user controls or input devices that can form the user input 262.
  • a variety of user interfaces such as a display that may form the output device 260 and a variety of user controls or input devices that can form the user input 262.
  • FIG. 5 shows a schematic illustration of a laser system 300, which can be a specific implementation of the laser system described above, or others described herein.
  • the laser system 300 can include an optical adapter 305 (which can also be referred to as an optical coupler, an optical module, etc.) as shown in FIG. 3
  • An optical adapter 305 which can also be referred to as an optical coupler, an optical module, etc.
  • a non-limiting list of components or features shown in FIG. 3 that can be included in the optical adapter 305 include at least one port, an inverse fiber combiner 381 (also, illustrated in FIG.
  • a laser power monitor 382 a quartz block 383, a collimating lens 384, beamsplitters 385a, 385b, an aiming beam source 386, a focusing lens 387, a protective window 388, a coupling lens 389, a filter 390, and a fiber connector 391.
  • the optical adapter 305 can be a multi-functional component, where the optical adapter 305 can direct light along different optical paths.
  • the optical adapter 305 can direct the laser radiation from the laser source into the surgical fiber 345 using lenses 384 and 387.
  • the optical adapter 305 can direct light to one or more detectors to monitor light back reflected from the target or non-target light, other light, etc.
  • a light source can emit a visible laser beam (e.g., green light as in FIG. 5) as an aiming beam into the surgical fiber 345 using the beamsplitter 385a.
  • the visible laser beam can be emitted toward the beamsplitter 385a, which can be directed by the beamsplitter 385a so that the visible laser beam is directed into the proximal end of the surgical fiber 345.
  • probe light from the source of probe light 330 can be directed into the proximal end of the surgical fiber 345 using a reflective prism or mirror.
  • Light that is transmitted back through the surgical fiber 345 from the distal end and to (and out) the proximal end can be separated using a beamsplitter and additional beamsplitters (not shown), can be directed into a single or multicore fiber (e g., using a coupling lens to direct the light into the fiber), and can deliver this light to one or more light detectors.
  • every light detector can be configured with a spectral filter to select a desired wavelength or wavelengths.
  • FIG. 6 shows a cross-sectional view of the multicore fiber 381.
  • the multicore fiber 381 includes multiple optical channels (e.g., seven as illustrated), with each optical channel being associated with a light detector, or a light source
  • each of the first, second, third, fourth, and sixth optical channels can be in optical communication with a respective light detector (or a respective light source).
  • the seventh optical channel can be in optical communication with a light source.
  • the first and second optical channels can be in optical communication with a first light detector
  • the third and fourth optical channels can be in optical communication with a second light detector
  • the fifth and sixth optical channels can be in optical communication with a third light detector.
  • each optical channel of the multicore fiber 381 can be in optical communication with a respective light source, and a respective light detector.
  • each respective light source can emit light into the respective optical channel of the multicore fiber 318, while each light detector can receive light from the respective optical channel.
  • each optical channel of the multicore fiber 318 can include a beamsplitter, each of which can facilitate directing light from a respective light source to a respective optical channel and receiving light from the respective optical channel and to the respective light detector. In some cases, this configuration of having a light source and a light detector for each optical channel can reduce the number of ports needed for the optical adapter 305.
  • the multicore fiber 381 can be substituted with multiple fibers. In this case, each of the multiple fibers corresponds to an optical channel of the multicore fiber 381.
  • FIG. 7 shows a schematic of another example of a laser system 500 with a surgical fiber 545 and an endoscope 560.
  • Laser system 500 can combine three types of light sources - a treatment laser, a pilot laser, and a probing light source. Light is distributed or otherwise guided from the proximal end to the distal end of the surgical fiber 545.
  • the surgical fiber 545 can be inserted into the endoscope 560 and may include a flexible component with the distal fiber tip.
  • the end of the endoscope 560 can be directed into the patient’s organ 552 (e.g., a urethra, a bladder, a ureter, a kidney, etc ).
  • An illumination light source 564 (e.g., an LED light source) can be provided at the distal end of the shaft of the endoscope 560, as shown in FIG. 7. This light source 564 can illuminate the operation/manipulation field inside the organ (or other location inside the patient).
  • the endoscope 560 can include a video camera (imaging sensor) 562 that can translate the real-time image of the operation/manipulation field onto an outside monitor/screen and optionally to an image processor.
  • the probing light source can be a laser light source having any one of a number of different wavelengths, including those that match the peak absorption of a target chromophore, non-limiting examples of which include 400-450 nm, 500-600 nm, 940 - 1100 nm, 1150-1350 nm, 1400-1600 nm, and 1850-2200 nm. In some instances, these wavelength(s) may correspond to specific physiological features. For instance, 400-450 nm and 500-600 nm relate to hemoglobin absorption, which can be used to distinguish between tissue and stone materials because soft tissue contains hemoglobin and stone does not (e.g., tissues absorb these wavelengths more than calculi).
  • a clinician or a computing device can cause the shaft of the medical scope to be inserted into the patient within the treatment region, and subsequently, can cause the fiber to be inserted into a working channel of the shaft of the medical scope until a distal end of the fiber is inserted through the shaft of the medical scope. While this discussion has been described with reference to a computing device, such is just one non-limiting example.
  • the process 600 can include a practitioner or clinician controlling the system and the medical scope, including positioning the scope and/or fiber in the patient and moving the fiber until the distal end of the fiber reaches the treatment region (e.g., at the predetermined distance from the treatment target).
  • characteristic criteria can mean a previously-generated optical data profile associated with a specific analytical conclusion based upon pre-clinical or clinical collection studies stored in the computing device. Such characteristic criteria may be temporal in nature, such as will be described with respect to FIG. 8B which provides a signal profile for reflecting light indicating stone or tissue being targeted, or may be based upon absolute or relative units, such as the spectral profiles found in FIGS. 9, 10, 11, and 12 identifying tissue and types of stones. Referring to FIG. 8B, a graph is provided showing one example of an optical data profile for use in laser treatment, such as described above.
  • the back reflection signal will be oscillating due to the bubbles that form and collapse (induced by the treatment laser) on the distal end of the surgical fiber and the corresponding back reflection scattered on these bubbles in interval 1702.
  • the back reflected light intensity will increase toward a maximal level achieved when in contact with the stone at 1704.
  • the oscillation amplitude and irregularity can also increase at the same time, due to additional back reflected light caused by the product of stone ablation.
  • the distal end of the fiber has lost contact with the stone.
  • the back reflection signal decreases, as illustrated at 1705, toward a level similar to precontact with stone at interval 1706. If the surgeon moves the fiber toward soft tissue, such as the ureter wall, the back reflection signal will increase at interval 1707 to a maximal level reached when in contact with the soft tissue, while the amplitude of oscillation will increase at 1708. As will be described, upon determining such a data profile, the laser sources may be disabled, the laser power may be decreased, the energy or interval between pulses may be adjusted, or the like, either by the surgeon or the system. This continues as the back reflection signal drops to a level typical for back reflection from tissue.
  • the control system may perform real-time comparisons of this optical data profile with a characteristic optical data profile
  • Several criteria can be used for the comparison.
  • the signal level 1717 and 1718 can be compared with known, non-contact and contact levels for contact with a target or without contact with a target, with or without treatment laser operation.
  • average levels 1711, 1714, maximum levels 1712, 1715, minimum levels 1713, 1716, an interval between oscillations 1718, length of oscillation, and a statistic related to time intervals and amplitude of oscillation or the like may be evaluated.
  • the characteristic or known optical data profile or key attributes thereof are processed against or compared to the optical data profiles collected in pre-clinical or clinical studies for different surgical treatment environments.
  • the computing device performs a comparison in real-time of the optical data profile with the characteristic optical data profile using one or multiple criteria.
  • the computing device may determine an integrated intensity by determining the area under the optical backrefl ection spectrum within a wavelength range (e.g., from 540 nm to 590 nm), or by summing together each intensity value for each wavelength of the data within a wavelength range. Then, a computing device can determine that the treatment target is a target material based on the integrated intensity value being greater than a criteria value, or a computing device can determine that the treatment target is a tissue based on the integrated intensity value being less than the criteria value.
  • a wavelength range e.g., from 540 nm to 590 nm
  • the process 600 can include a computing device determining a type of target material (e g. a uric stone, a calcium oxalate monohydrate stone, a cysteine stone, or the like.) for the treatment target based on the data, after for example, a computing device determined that the treatment target is a target material.
  • a computing device can follow a similar process at block 610 to determine the type of target material from a plurality of possible types of target material. For example, a computing device can compare a profile or an intensity value for a wavelength to a criteria value and can determine the type of target material based on the comparison to a characteristic profile or intensity.
  • a computing device can compare an integrated intensity value to a criteria and can determine the type of target material based on the comparison.
  • a computing device can determine a type of target material, based on comparing an intensity profile from the data to a characteristic profile.
  • the computing device can compare an amplitude of a wavelength(s) to one or more criteria values. For example, a computing device can determine that the target material is a uric stone, based on an amplitude of a selected wavelength of the data (or an integrated intensity value) being greater than a first criteria and a second criteria, with the second criteria being larger than the first criteria.
  • a computing device can determine that the target material is a calcium oxalate monohydrate stone, based on the amplitude of the wavelength of the data (or the integrated intensity value) being between the first criteria and the second criteria. As yet another example, a computing device can determine that the target material is a cysteine stone, based on the amplitude of the wavelength of the data (or the integrated intensity value) being less than the first criteria and the second criteria.
  • the process 600 can include a computing device for determining a distance between the distal end of the fiber and the treatment target, based on the determined treatment target.
  • different treatment target types or features e.g., size
  • can have a corresponding predetermined desired distance associated therewith e.g., stored in a database.
  • a computing device can receive a predetermined distance that is associated with the determined treatment target or target feature, such as size, (e.g., in a database).
  • a computing device can receive a predetermined distance for the treatment target corresponding to a target material (and/or size of the target material), based on a computing device determining that the treatment target is a target material (and the type of the target material).
  • a computing device can receive a predetermined distance for the treatment target corresponding to a tissue, based on the computing device determining that the treatment target is a tissue.
  • predetermined distances can be optimized for specific treatment targets.
  • treatment targets that are tissue are desired to have a greater distance than calculi.
  • harder stone types can benefit from a smaller distance (e.g., more focused laser light being directed at a harder stone) as opposed to softer stone.
  • the distance can be smaller than a predetermined distance for a tissue, and when the treatment target has been determined to be tissue, the distance can be greater than a predetermined distance for stone.
  • the process 600 can include a computing device determining laser operation parameters for a treatment laser, based on the above analysis.
  • the laser operation parameters for the treatment laser can include one or more of a pulse peak power, a pulse shape, a pulse width, an interval between pulses, a frequency of the laser light, a power of the laser light (e.g., an average power), a total duration of the laser light, and the like.
  • a computing device can receive one or more predetermined laser operation parameters for the treatment target corresponding to a target material (and in some instances a type of the target material), based on a computing device determining that the treatment target is a target material (and the type of the target material).
  • a computing device can receive one or more predetermined laser operation parameters for the treatment target corresponding to a tissue, based on the computing device determining that the treatment target is a tissue.
  • having predetermined laser operation parameters can be advantageous in that the predetermined laser operation parameters can be tailored to a specific treatment target and type thereof.
  • tissue benefit from CW power operation and calculi benefits from pulse operation with high peak power (e.g., because higher amounts of laser light directed to calculi can be advantages to fracture the target material).
  • one or more predetermined laser operation parameters for tissue can be lower than one or more predetermined laser operation parameters for calculi (and vice versa).
  • one or more predetermined laser operation parameters for a first type of calculi can be higher than one or more predetermined laser operation parameters for a second type of calculi (e.g., with the first type of calculi being harder than the second type of calculi).
  • block 616 can include a computing device notifying a practitioner based on the results from one or more determinations.
  • a computing device can present on a display of a laser system or endoscopic image the results of the determination from the block 610, which can include presenting on a display that the treatment target is a treatment target material or a non-treatment target material.
  • a computing device can present on a display the determined distance (e.g., a predetermined distance) associated with the treatment target and/or can present on the display the determined laser operation parameters associated with the treatment target, etc.
  • the treatment target has already been predetermined to be tissue, or target material (and a type thereof).
  • the process 600 can be used to determine that the current treatment target (e.g., in front of the distal end of the fiber) matches with the predetermined treatment target.
  • a computing device can determine that the current treatment target (e.g., determined at the block 610, 612) corresponds or does not correspond with the predetermined treatment target. If a computing device determines that the current treatment target matches with the predetermined treatment target, then a computing device can control operation of the treatment laser (e.g., including enabling firing of the treatment laser, causing the treatment laser to emit laser light, increasing one or more laser operation parameters for the treatment laser such as average power, peak power, etc.).
  • a computing device determines that the current treatment target does not match with the predetermined treatment target (e.g., that the predetermined treatment target is stone and the current treatment target is tissue), then the computing device can control operation of the treatment laser (e.g., including disabling firing of the treatment laser, stopping the treatment laser from emitting laser light, changing one or more laser operation parameters such as decreasing laser power).
  • the computing device determines that the current treatment target does not match with the predetermined treatment target, then the computing device can alert a practitioner by, for example, presenting an alert on the display, flashing or sound. In this way, during a laser procedure, a computing device can, in real time, adjust operation of the treatment laser if the current treatment target is not the actual predetermined treatment target, which can prevent undesirable firing of the laser, increase treatment efficiency and safety, etc.
  • the treatment target can be identified to be a stone target material versus tissue, because stone can reflect, scatter, etc., a greater amount of light than does tissue - especially within particular wavelength ranges (e.g., a wavelength ranges of 410 nm to 460 nm and 550 nm to 590 nm) in which the tissue absorbs light within the wavelength range (e.g., due to hemoglobin absorbing the light).
  • FIG. 9 is a graph showing examples of the optical back reflected spectrums of back reflected light (reflected and scattered from a surface of stone or tissue, back scattered from bulk stone or tissue, etc.) of a scope LED illumination from different types of stone and kidney tissue.
  • FIG. 10 is a graph showing examples of the same spectra of back reflected/scattered LED light from stones and from soft tissue but normalized to the original LED spectrum. These spectra can be used for identification of different types of stones and soft tissues. Various stone types and their differentiation against soft tissue can be identified by spectrum analysis (e.g., through differentiating or integrating the spectral curves in all regions or in the most sensitive spectral ranges). This information can be used for identification of stone or stone type and soft tissue before applying laser energy.
  • FIGS. 13 and 14 collectively show a flowchart of a process 700 for determining a distance between a distal end of a fiber and a treatment target.
  • the process 700 can be implemented using any of the laser systems described herein (e.g., the laser system 100), and the process 700 can be implemented using one or more computing devices as appropriate (e.g., the computing device 150).
  • the process 700 can include a computing device (or operator) moving a fiber to a treatment region that includes a treatment target, which can be similar to block 602 of process 600.
  • process 700 can include a computing device causing a light source to emit a first light toward the treatment region, according to a calibration procedure, which can be similar to block 604 of process 600.
  • the process 700 can include a computing device causing a treatment laser to emit laser light toward the treatment region.
  • the laser light can have a laser pulse
  • the first light can have one or more pulses (e.g., three pulses).
  • a first pulse of the first light can be emitted before the laser pulse (e.g., the first light being emitted before the leading edge of the laser pulse), a second pulse of the first light can be emitted during emission of the laser pulse (e.g., the second pulse being situated between a rising edge of the laser pulse and a falling edge of the laser pulse), and a third pulse of the first light can be emitted after emission of the laser light (e.g., after the trailing edge of the laser pulse).
  • An example of this configuration is shown in the upper region of FIG. 15, in which the first light is the probing source (light), and the first, second, and third pulses of the first light correspond to the pulse A, the pulse B, and the pulse C, respectively.
  • the first light can be emitted continuously before, during, and after the emission of the laser pulse.
  • the first light can include a first pulse which can be emitted before, during, and after the emission of the laser pulse.
  • An example of this configuration is shown in the lower region of FIG. 15, in which the first light is the probing source (light) that is emitted before, during, and after the laser pulse.
  • the process 700 can include directing a portion of the first light to a light detector, which can be similar to block 606 of process 600.
  • process 700 can include a computing device receiving first data from the light detector, which can correspond to the portion of the reflected first light (e g., having been filtered) interacting with the light detector.
  • Block 710 can be similar to block 608 of process 600.
  • the portion of the reflected first light which is directed to the light detector to generate the first data, can be directed back into the distal end of the fiber and emitted out the proximal end of the fiber to the light detector.
  • the portion of the reflected first light can correspond to one or more sections of the first light, with a first section being emitted before the laser pulse, with a second section being emitted during the laser pulse, and with a third section being emitted after the laser pulse.
  • process 700 can include a computing device determining one or more calibration values, based on the first data (e.g., which can be filtered).
  • the data can include one or more first intensity values corresponding to the first light being emitted before the laser pulse (e.g., the first section of the portion of the first light), one or more second intensity values corresponding to the first light being emitted during the emission of the laser pulse (e.g., the second section of the portion of the first light), and one or more third intensity values corresponding to the first light being emitted after the emission of the laser pulse (e.g., the third section of the portion of the first light).
  • the one or more first intensity values can correspond to the treatment region being free of a bubble (e.g., at the distal end of the fiber)
  • the one or more second intensity values can correspond to the treatment region including a bubble (e.g., at the distal end of the fiber)
  • the one or more third intensity values can correspond to the treatment region including a vapor channel through the bubble.
  • process 700 can include a computing device (or operator) moving the fiber to the treatment region. In some cases, this can include a computing device moving a distal end of the fiber to a predetermined distance (e.g., using process 600) relative to the treatment target.
  • Block 714 can be similar to block 702.
  • process 700 can include a computing device causing the treatment laser to emit second laser light towards the treatment region
  • block 716 can be omitted if, for example, the treatment laser is to only emit laser light after determining the distance.
  • process 700 can include a computing device causing the light source (or a different light source) to emit a second light toward the treatment region, which can be similar to block 704.
  • the same light source can be advantageous in that the calibration procedure can be tailored to the particular light source.
  • process 700 can include directing a portion of the reflected second light (e.g., which can be filtered) to the light detector (or a different light detector), which can be similar to block 708.
  • process 700 can include a computing device receiving (and filtering) second data from the light detector (or the different light detector), which can be similar to block 710.
  • process 700 can include a computing device determining a distance between a distal end of the fiber and the treatment target based on the second data (and based on one or more of the calibration values).
  • a computing device can compare an intensity value from the second data to a curve that relates intensity values and distances (of the distal end of the fiber to the treatment target).
  • the curve can be associated with the type of treatment target (e.g., target material (and corresponding type) or tissue).
  • a computing device can calibrate the second data by applying one or more (e.g., a combination) of the first, second, or third calibration values to each intensity value of the second data, depending on when the second data was acquired relative to the second laser light (if applicable).
  • the distance determined at block 724 can be a current distance.
  • a computing device can determine the difference between the current distance and the predetermined distance, and present on a display the difference (or otherwise notify a practitioner of the difference).
  • a computing device can control operation of the treatment laser (e.g., including enabling firing of the treatment laser, causing the treatment laser to emit laser light, increasing one or more laser operation parameters for the treatment laser to operate according to, etc.).
  • a computing device determines that the current distance does not exceed the predetermined distance, then the computing device can control operation of the treatment laser (e.g., including disabling firing of the treatment laser, stopping the treatment laser from emitting laser light, decreasing one or more laser operation parameters, etc.).
  • the computing device determines that the current distance exceeds the predetermined distance, then the computing device can alert a practitioner by, for example, presenting an alert on the display. In this way, during a laser procedure, a computing device can, in real time, adjust operation of the treatment laser if the current distance deviates from the predetermined distance, which can prevent undesirable firing of the laser, can increase treatment efficiency, etc.
  • the target material moves (e.g., known as retropulsion) and in this case because the distance between the distal end of the fiber and the treatment target can be determined, tissue is not undesirably treated with laser light (e.g., the computing device can cause the treatment laser to stop firing).
  • the treatment laser is not always in the line of site with each of these particles. So, when a particle is close enough to the distal end of the fiber, the computing device can cause the treatment laser to fire, thereby creating an automatic firing procedure as particles are brought close enough to the distal end of the fiber - even when images from a medical scope are obscured.
  • the probe source can also be a continuous wave source, as shown in FIG. 15. With this calibration procedure complete, the doctor can proceed to the treatment.
  • the computing device registers or otherwise detects incoming response signals initiated by the probing source that are reflected back from the distal end of the fiber.
  • the computing device can compare this response signal(s) with signal A of the calibration procedure.
  • a “contact coefficient” parameter can be implemented that is more precise than absolute values that may differ from time to time depending on multiple circumstances.
  • FIG. 16 is a graph showing the relationship between the contact coefficient for stone and soft tissue and the gap between the fiber tip and the target using a probing source wavelength of 1550 nm. As a soft tissue sample, kidney tissue was used.
  • the graph in FIG. 16 indicates that by approaching soft tissue up to the point of full contact, KI increases from 0 up to 0.33, and for stone material KI increases from 0 to 1.39. It is to be appreciated however, that the specific KI values will depend on several application-specific factors, including the laser, the optical system, the overall system design that is being implemented, the fiber diameter, and other parameters. The KI values should therefore be evaluated in advance for each laser system design.
  • the level of the probing source response signal can be at its maximum (Fresnel reflection on air is maximum and backscattering of a porous crater and of tracking microparticles is maximum)
  • the probing source response signal should be something in between these minimum and maximum levels.
  • FIG. 18 is a graph showing the relationship between the contact coefficient KI for different types of stone and soft tissue where the fiber tip is in contact with the target (the gap between the fiber tip and the target is 100 microns or less) using a probing source wavelength of 1550 nm at 15 different points of stone or tissue.
  • soft tissues chicken breast, pork kidney and beef heart
  • uric acid stone KI 0.6-1 8.
  • KI can depend on various other parameters such as the probing source wavelength, the fiber diameter, the fiber distal end angle to stone surface, the condition of the fiber distal end, the distance between the fiber distal end to the stone surface (as described above), the current laser system design, and many other factors.
  • the determined KI coefficients will relate to different types of stone as is shown in FIG. 18. This can be used in real time to distinguish between different types of stone with a high probability. If the doctor is able to have such assistance during surgery with the described stone type detector, he or she (and/or the control system) will be able to select (choose) the best laser parameters (such as pulse power, width, frequency and other) in order to fragment the determined type of calculi with the highest possible efficiency. In some instances, this parameter can be predetermined and pre-set into the smart laser system (e.g., the control system) for purposes of proposing (suggesting) or otherwise conveying to the doctor the currently determined stone type that is in front of the fiber tip during surgery.
  • the smart laser system e.g., the control system
  • a computing device controlled laser system can therefore be used to receive and analyze response signals corresponding to the probing source in real time before, during, and after laser pulses for purposes of distinguishing between contact with stone vs. soft tissue.
  • image data from the imaging sensor of the scope can provide information regarding contact detection with stone and with soft tissue, and the results from image processing can be used to determine the stone and soft tissue type and condition.
  • the system can also assist in controlling the laser for purposes of helping the doctor make more informed decisions, increase the efficiency of the stone treatment, shorten the procedure time, and to avoid injuries caused by improper positioning of the fiber tip during laser pulses where the camera’s view is limited by stone dust.
  • FIG. 19 is one example of a functional schematic of the laser system.
  • the synchronizing signal originates in a clock generator.
  • a laser source such as a laser diode emits a probe pulse on each arrival of the clock forefront.
  • the period of pulses is greater than the longest time of flight of a pulse that goes from the beginning to the end of an instrument and then backward.
  • the forefront duration can be less than 0. 1 ns, and the pulse duration can be several nanoseconds. Low average power is ensured by a short pulse duration and a large period of pulses. If the power is insufficient for stable detection of a reflected signal, then the pulses are additionally amplified.
  • the laser emission is then coupled into the fiber instrument and partly reflected from the distal end of the fiber or a crack in the fiber.
  • the reflected power can be too small to be detected. This situation is discussed in further detail below.
  • the reflected pulse is received by a sensor such as a photodiode.
  • the signal is then digitized by a comparator, and the reference level of the comparator is then adjusted.
  • the target level of the comparator is half the amplitude of the pulse.
  • the reflected signal goes to the data input of a D flip-flop.
  • a synchronizing signal is delayed in a phase-locked loop by a variable magnitude with a step less than 0. 1 ns and goes to a clock input of the D flip-flop.
  • the result of a comparison between these two inputs is latched at different moments of time, which makes it possible to fix the moment of transition of the result of the comparison from zero to one, and consequently to fix the forefront of the reflected pulse.
  • the delay of a latching clock is scanned step-by-step over all delay ranges that correspond to a length of a fiber instrument.
  • the moment of pulse return is fixed and the fiber length is measured.
  • the range of delays that correspond to a small zone around the tip of the fiber instrument is employed. In this instance, the reflection of a pulse from a tip is fixed. If the reflected pulse disappears, two variants are possible: a crack inside a fiber, or a very large cleave angle at the tip of the fiber instrument. Both situations demand immediate termination of laser emission. Operation of a device in the first regime gives detailed information about the fiber instrument, but the second regime takes less time.
  • calculi e.g., kidney stones, ureter stones, etc.
  • soft tissues have different structures (and material properties) that create specific responses by a probing light (e.g., light from one of the light source(s)).
  • a probing light e.g., light from one of the light source(s)
  • different stones can have different chemical compositions, with stones in general mostly containing minerals with water present in the inter-crystalline and microcrystalline spaces (e.g., about 10% of the total volume of the stone).
  • stones can contain small organic molecule additions, and each stone can have different micro structures, macro structures, shapes, surface structures, and conditions. Each of these can define the stone’s optical properties, which can include a spectrum of the absorption, a spectrum of the scattering coefficients, the angle distribution of scattered light, etc.
  • tissues e.g., kidney, ureter, soft tissues, etc.
  • tissues can include an organic extracellular matrix, vascular systems, and cells.
  • tissues and stones e.g., tissues containing substantially 70-80% water, while stones can contain substantially 10% water
  • tissues can have a non-porous structure and smoother surface (as compared to stones).
  • tissues have different optical properties than stones.
  • tissues can scatter light less than stone material (e.g., in most conditions), especially in the ranges of wavelengths where there is significant water or blood absorption (e.g., the light being absorbed by the tissues and thus not scattering).
  • the light directed back into the distal end of the fiber can be used to determine (e.g., by a computing device) if the treatment target (or other structure near the fiber) is stone, or is tissue.
  • the light directed back into the distal end of the fiber can even discern the type of stone, if, for example, the treatment target has been determined to be a stone.
  • the amount of the light directed back into the distal end of the fiber increases (e.g., the probing light reflecting off the target and being directed into the distal end of the fiber).
  • the amount of the light directed back into the distal end of the fiber e.g., derived from a light source that emits the probing light
  • the amount of the light directed back into the distal end of the fiber is maximized at least because more of the light is directed back into the fiber rather than being dissipated within the treatment region.
  • the probing light can be a broad continuous spectrum source (e.g., the probing light having one or more wavelengths within a range of substantially 400 nm to substantially 750 nm), such as an LED or a lamp for purposes of obtaining a broad spectrum back-reflected signal from the tissue or stone.
  • a broad continuous spectrum source e.g., the probing light having one or more wavelengths within a range of substantially 400 nm to substantially 750 nm
  • an LED or a lamp for purposes of obtaining a broad spectrum back-reflected signal from the tissue or stone.
  • the wavelength selection is performed in the detection arm via the optical filters 690a-690i.
  • the spectral bands may be selected from the following list (although it is to be appreciated that this list is exemplary and that other wavelengths may be used as well): about 400-410 nm, about 440-480 nm, about 460-480 nm, about 510-530 nm, about 540-560 nm, about 550-570 nm, about 570-580 nm, about 580-600 nm, about 600-620 nm, about 690-710 nm, about 740-760 nm, about 790-810 nm, about 920-940 nm, about 970-990 nm, and about 1150-1350 nm.
  • FIG. 21a shows a flowchart of a process 1000 for an in-patient calibration procedure according to one embodiment.
  • the process 1000 can be implemented using system 600.
  • the process 1000 can include delivering the fiber to a surgical treatment area. This may include inserting the fiber into a scope and delivering the scope to the treatment area. Step 1002 may be performed by a surgeon or a device configured to perform this step.
  • the calibration procedure initiates. Using the image from the FOV of the camera positioned on the distal end of the scope, the doctor positions the tip in front of one or more various known target materials and obtains reflected intensity values from the photodetectors 646 that are coupled to the computing device 650.
  • the distal end of the surgical fiber is positioned to be in quasi-contact with at least one known target.
  • multiple reflected light intensity values are obtained from each known target of at least one known target.
  • the at least one known target is stone, tissue, a surgical component, or a surgical treatment area medium, which may also be referred to herein as a liquid medium (e g., aqueous environment inside kidney).
  • the at least one known target is tissue.
  • at least two known targets are used. In certain embodiments, the two known targets may be stone and tissue.
  • tissue is the known target material
  • data reflected intensity signal data
  • a predetermined period of time e.g. 20 seconds
  • the treatment laser power can be disabled or lowered to a safe level for soft tissue, and for stone material, the treatment laser can be configured to emit power above the ablation threshold for the stone to guarantee contact or quasi-contact between the fiber tip and stone (typically 0-1.5 mm). For instance, if stone is the known target material, then at 1008 the distal end of the scope is moved over the target stone for a predetermined period of time (e.g., 1-20 seconds) and data is collected (e.g., by having the surgeon depress a foot pedal) while the treatment laser 610 is on, but at a low pulse energy setting.
  • a predetermined period of time e.g. 1-20 seconds
  • the pulse energy may be less than 0.5 J, with some examples having a pulse energy of 0.025 to 0.1 J, with a 10-100 Hz repetition rate and an average power of 1 to 10 watts (W).
  • the pulse energy is sufficient to create some dusting as the operator moves the fiber across the stone surface.
  • the pulse energy is about 0. 1 J with a peak power at about 500 W, with a 60 Hz repetition rate.
  • the settings ensure that the calibration signal is obtained from the bulk of the stone, and not only from a thin superficial layer that may not be representative of the actual stone. Reflected light from light source 615 during this action is detected by the detection channels.
  • the process 100 can include a computing device (feedback analyzer 650) analyzing data received from the detection channels This includes utilizing one or more “baseline” raw reflected intensity signals and calculated ratios of reflected light intensity within selected bands of wavelengths from each type of material that is stored in a database of the computing device.
  • a computing device feedback analyzer 650
  • a ratiometric technique can be applied to the reflected intensity data obtained from the known targets (and targets that may be unknown or otherwise not verified) during the procedure, as explained in further detail below.
  • At least one ratio of a reflected light intensity of one selected wavelength band to a reflected light intensity of a different selected wavelength band is generated or otherwise calculated by computing device 650 at step 1012.
  • three different photodetectors are used (i.e., three channels) which yield a reflected intensity values for each wavelength band: wavelength band 1 (Ii), wavelength band 2 (I2), and wavelength band 3 (I3).
  • FIGS. 22a and 22b are frequency distributions in the form of histograms (for a distribution of ratios of reflected signal intensity collected during calibration) of two different examples of stone and soft tissue distinction, where FIG. 22a shows an example of a “good” separation (where the reflected intensity ratios indicate the target is the desired target e.g., a stone and not tissue), and FIG. 22b shows an example of a “bad” separation (where the reflected intensity ratios indicate that either the target is not the desired target (tissue, when the desired target is stone) or it is not clear that the desired target is one or the other).
  • the in-patient calibration establishes differentiation between soft tissue and calculi (e.g., see FIGS. 22a and 22b).
  • the reflected signals are collected in all N wavelength channels.
  • N(N-l)/2 unique pairs of the signals are formed, the respective signal ratios are computed, and each pair is analyzed in terms of quality of stone-tissue separation.
  • FIG. 22a may be the result from Ri (using the example from above), and
  • FIG. 22b may be the result from R3.
  • Ssso the Ri ratio value associated with the 80 th percentile for stone
  • the line marked “Max” in FIG. 22a may mark STSO (the Ri ratio value associated with the 80 th percentile for tissue) where 80% of the tissue histogram data falls to the right of STSO and 20% of the tissue histogram data falls to the left of STSO.
  • STSO the Ri ratio value associated with the 80 th percentile for tissue
  • the line marked “Min” in FIG. 22b may mark Ssso (the R3 ratio value associated with the 80 th percentile for stone)
  • the line marked “Max” in FIG. 22b may mark STSO (the R3 ratio value associated with the 80 th percentile for tissue).
  • the predetermined percentile is in a range selected from 50 th to 97 th , and in further embodiments, the predetermined percentile is in a range selected from 75 th to 95 th , and in yet further embodiments, the predetermined percentile is the 80 th percentile, and in some embodiments the predetermined percentile is the 95 th percentile.
  • a difference value between the ratio values associated with the predetermined percentiles for each known target is accepted as an indicator for the quality of separation. This is shown as step 1018 in FIG. 21a.
  • This step may include determining a difference value between a first ratio value associated with the predetermined percentile for a first known target (of at least two known targets) and a second ratio value associated with the predetermined percentile for a second known target.
  • the wavelength pair with the best separation e.g., the ratio value R associated with the largest difference value R, as explained in further detail below
  • the difference value between Ssso and STSO for Ri of FIG. 22a is designated as RI in FIG. 22a and the difference value between Ssso and STSO for Rs of FIG. 22b is R 3 in FIG. 22b.
  • the analysis output of step 1012 may employ a form other than a frequency distribution in the form of a histogram (step 1014) as the output.
  • the analysis may produce graphical or other types of data representations and models (e.g., pie charts, bar charts, data matrix), or any other output capable of functioning as a basis for the determining the ratio value associated with the predetermined percentile for each known target.
  • the difference value (associated with each ratio value) is compared to a threshold difference value.
  • the threshold difference value RI (a first difference value) is R3 (a second difference value) and computing device 650 determines whether the first difference value or the second difference value is larger. In response to a determination that the first difference value is larger than the second difference value, then the first difference value is selected as the threshold difference value, and in response to a determination that the second difference value is larger than the first difference value, selecting the second difference value as the threshold difference value.
  • RI is larger than R3, signifying a greater degree of separation
  • RI may be chosen or otherwise be used as the threshold difference value.
  • a threshold difference value may be established by an operator, or may be established by the computing device 650 (e.g., on the basis of stored data, other stored information, mathematical algorithm(s), etc.).
  • SSP may also be defined in various ways.
  • SSP can be computed as an average of STSO and Ssso, which is explained in further detail below.
  • a threshold ratio value (or range of values) can be established that is based at least in part on the first ratio value and the second ratio value (e.g., establishing a threshold ratio value based at least in part on the multiple reflected light intensity values from each known target).
  • the threshold ratio value can be considered to be based at least in part on the multiple reflected light intensity values from each known target. This can be performed by the computing device 650 and is shown as step 1022 in FIG. 21a. For instance, using the example from above, FIG. 22a (associated with Ri) RI that meets or exceeds the threshold difference value.
  • the first ratio value associated with the predetermined percentile for the first known target (stone) is approximately 0.57 in FIG. 22a.
  • the second ratio value associated with the predetermined percentile for the second known target (tissue) is approximately 0.66.
  • a threshold ratio value may be established or otherwise determined based on the first ratio value and the second ratio value. For example, an average ratio value based on the first and second ratios may be established as the threshold ratio value. Referring to FIG. 22a, the line marked “Medium” line as shown in FIG. 22a marks an average (i.e., 50%) between the 0.57 value of the first ratio and the 0.66 value of the second ratio. This line can be established as the threshold ratio value (having a value of approximately 0.61 for this example in FIG 22a).
  • a comparison of a ratio obtained during a “live” surgical treatment procedure can be compared against the threshold ratio value.
  • a target in the “live” surgical treatment area during the course of an actual procedure
  • Ri values associated with a target in an actual surgical treatment area during a procedure can be compared to the threshold ratio value of 0.61. Ratio values greater than 0.61 (to the right of the 50% line) will associate the target in the actual surgical treatment area with tissue material and ratio values less than 0.61 (to the left of the 50% line) will associate the target in the actual surgical treatment area with stone material.
  • the computing device 650 is configured to establish each ratio associated with the predetermined percentile as a threshold ratio value for the respective known material.
  • the threshold ratio value can be used during an actual procedure to verify that the object in front of the camera is the actual desired target. For instance, using the RI meets or exceeds the threshold difference value, and the ratio values associated with the 80 th percentiles for each of tissue and stone can be used during an actual procedure.
  • the threshold ratio value for Ri is approximately 0.57 and for tissue the threshold ratio value for Ri is approximately 0.66 in the example shown in FIG. 21a.
  • the target can be associated with the known target.
  • the ratio value for Ri obtained from “live” measured reflected intensity data meets or exceeds the predetermined percentile associated with the corresponding threshold ratio value
  • the target can be associated with the known target. For example, if the Ri value from the “live” procedure is calculated as 0.55, then this value meets or exceeds the 80 th percentile (predetermined percentile) associated with the corresponding threshold ratio value of 0.57 for Ri of the known stone material and the target material can be associated with a known target (in this case stone).
  • selection criterion may perform the functionality of the threshold ratio value.
  • other math formulas or algorithms may be used to establish a source of comparison or setting a reference.
  • the selection criteria may be automatically and dynamically adjusted during the procedure, based on the log (store data) of recorded stone/non-stone signals and operator’s actions.
  • one or more components of the calibration may be implemented using a computing device, such as a computer processor.
  • software may be provided on the computing device that performs one or more steps of the calibration procedure and can include prompts for the operator (e.g., position the fiber to obtain reflected intensity values from a known target such as tissue or stone).
  • software may also be provided on the computing device that performs one or more steps of the procedure (after calibration), which is discussed in further detail below.
  • the analysis performed in the calibration forms the basis for the actual treatment procedure.
  • a flowchart for one example of a lithotripsy procedure or process 1055 is shown in FIG. 21b in accordance with one embodiment.
  • the analysis performed in the calibration forms the basis for the actual lithotripsy procedure, including the basis for whether an automatic mode 1071 is initiated (or recommended to a surgeon), or the system recommends remaining in manual mode at 1073 during the actual procedure.
  • the reflected signal intensities may also be used during the course of a procedure.
  • at least one ratio for a target in the surgical treatment area can be determined by computing device 650 from the reflected intensity value (s) using the photodetectors 646a-646i. This is shown as step 1065 in FIG. 21b.
  • Ri would be determined for an actual target in the surgical treatment area.
  • the ratio value Ri of an actual target would then be compared (e.g., by the computing device 650) with the threshold ratio value that was determined in the calibration routine (as indicated at step 1067 in FIG. 21b).

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Abstract

L'invention concerne un procédé de commande d'un système laser chirurgical qui comprend la fourniture d'une fibre chirurgicale configurée pour recevoir de la lumière réfléchie par une cible dans une zone de traitement chirurgical et délivrer un rayonnement laser d'une source laser de traitement à une cible de traitement, et la fourniture d'un dispositif informatique configuré pour s'associer à au moins deux photodétecteurs, chaque photodétecteur étant configuré pour détecter une intensité de lumière réfléchie par la cible dans une bande de longueur d'onde sélectionnée différente ; le dispositif informatique étant en outre configuré pour : recevoir l'intensité lumineuse réfléchie dans au moins deux bandes de longueur d'onde sélectionnées, générer des données optiques correspondant à l'intensité lumineuse réfléchie, et identifier la cible en tant que cible de traitement ou cible de non-traitement sur la base, au moins en partie, des données optiques et d'un étalonnage prédéterminé sur la base d'au moins une cible connue.
PCT/US2024/061303 2023-12-29 2024-12-20 Systèmes et procédés de commande de traitements laser utilisant des signaux d'intensité réfléchis Pending WO2025144715A1 (fr)

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Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US6377841B1 (en) * 2000-03-31 2002-04-23 Vanderbilt University Tumor demarcation using optical spectroscopy
US20060025692A1 (en) * 2004-07-30 2006-02-02 Olympus Corporation Endoscope apparatus
WO2013044182A1 (fr) * 2011-09-22 2013-03-28 The George Washington University Systèmes et procédés de visualisation de tissu enlevé
KR20180078272A (ko) * 2015-10-28 2018-07-09 스펙트랄 엠디, 인크. 조직 분류를 위한 반사 모드 멀티스펙트럴 시간 분해된 광학 이미징 방법들 및 장치들
WO2021166749A1 (fr) * 2020-02-18 2021-08-26 ソニー・オリンパスメディカルソリューションズ株式会社 Dispositif d'apprentissage et dispositif de traitement d'images médicales

Patent Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US6377841B1 (en) * 2000-03-31 2002-04-23 Vanderbilt University Tumor demarcation using optical spectroscopy
US20060025692A1 (en) * 2004-07-30 2006-02-02 Olympus Corporation Endoscope apparatus
WO2013044182A1 (fr) * 2011-09-22 2013-03-28 The George Washington University Systèmes et procédés de visualisation de tissu enlevé
KR20180078272A (ko) * 2015-10-28 2018-07-09 스펙트랄 엠디, 인크. 조직 분류를 위한 반사 모드 멀티스펙트럴 시간 분해된 광학 이미징 방법들 및 장치들
WO2021166749A1 (fr) * 2020-02-18 2021-08-26 ソニー・オリンパスメディカルソリューションズ株式会社 Dispositif d'apprentissage et dispositif de traitement d'images médicales

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