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WO2025215589A1 - Systèmes d'ablation laser dans les ovaires à l'aide d'une rétroaction d'ajustement de tissu - Google Patents

Systèmes d'ablation laser dans les ovaires à l'aide d'une rétroaction d'ajustement de tissu

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Publication number
WO2025215589A1
WO2025215589A1 PCT/IB2025/053800 IB2025053800W WO2025215589A1 WO 2025215589 A1 WO2025215589 A1 WO 2025215589A1 IB 2025053800 W IB2025053800 W IB 2025053800W WO 2025215589 A1 WO2025215589 A1 WO 2025215589A1
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WO
WIPO (PCT)
Prior art keywords
target tissue
laser
optical
controller
optical fiber
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Pending
Application number
PCT/IB2025/053800
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English (en)
Inventor
Nofar WAGNER
Eytan FREY
Avshalom MOR
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Maxovary23 Ltd
Original Assignee
Maxovary23 Ltd
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Filing date
Publication date
Application filed by Maxovary23 Ltd filed Critical Maxovary23 Ltd
Publication of WO2025215589A1 publication Critical patent/WO2025215589A1/fr
Pending legal-status Critical Current
Anticipated expiration legal-status Critical

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    • A—HUMAN NECESSITIES
    • 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
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B2017/00017—Electrical control of surgical instruments
    • A61B2017/00022—Sensing or detecting at the treatment site
    • A61B2017/00057—Light
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B2017/00017—Electrical control of surgical instruments
    • A61B2017/00022—Sensing or detecting at the treatment site
    • A61B2017/00057—Light
    • A61B2017/00061—Light spectrum
    • A—HUMAN NECESSITIES
    • 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
    • A61B2018/00315—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body for treatment of particular body parts
    • A61B2018/00559—Female reproductive organs
    • A—HUMAN NECESSITIES
    • 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
    • A61B2018/00571—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body for achieving a particular surgical effect
    • A61B2018/00577—Ablation
    • A—HUMAN NECESSITIES
    • 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
    • A61B2018/00636—Sensing and controlling the application of energy
    • A61B2018/00642—Sensing and controlling the application of energy with feedback, i.e. closed loop control
    • A—HUMAN NECESSITIES
    • 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
    • A61B2018/00636—Sensing and controlling the application of energy
    • A61B2018/00666—Sensing and controlling the application of energy using a threshold value
    • A61B2018/00678—Sensing and controlling the application of energy using a threshold value upper
    • A—HUMAN NECESSITIES
    • 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
    • A61B2018/00636—Sensing and controlling the application of energy
    • A61B2018/00696—Controlled or regulated parameters
    • A61B2018/00702—Power or energy
    • A—HUMAN NECESSITIES
    • 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
    • A61B2018/00636—Sensing and controlling the application of energy
    • A61B2018/00696—Controlled or regulated parameters
    • A61B2018/00732—Frequency
    • A—HUMAN NECESSITIES
    • 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
    • A61B2018/00636—Sensing and controlling the application of energy
    • A61B2018/00696—Controlled or regulated parameters
    • A61B2018/00761—Duration
    • A—HUMAN NECESSITIES
    • 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
    • A61B2018/00636—Sensing and controlling the application of energy
    • A61B2018/00773—Sensed parameters
    • A61B2018/00779—Power or energy
    • A61B2018/00785—Reflected power
    • A—HUMAN NECESSITIES
    • 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
    • A61B2018/00636—Sensing and controlling the application of energy
    • A61B2018/00773—Sensed parameters
    • A61B2018/00791—Temperature
    • A—HUMAN NECESSITIES
    • 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
    • A61B2018/00636—Sensing and controlling the application of energy
    • A61B2018/00773—Sensed parameters
    • A61B2018/00791—Temperature
    • A61B2018/00821—Temperature measured by a thermocouple
    • A—HUMAN NECESSITIES
    • 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
    • A61B2018/00636—Sensing and controlling the application of energy
    • A61B2018/00904—Automatic detection of target tissue
    • A—HUMAN NECESSITIES
    • 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
    • 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

Definitions

  • the present disclosure relates to systems and methods for treating an ovary of a subject, particularly systems and methods for precisely controlling ablation using tissue adjustment feedback to mitigate symptoms of Polycystic Ovary Syndrome (PCOS).
  • PCOS Polycystic Ovary Syndrome
  • Polycystic Ovary Syndrome is a complex endocrine disorder, first characterized in the 1930s, with multifaceted implications spanning reproductive and non-reproductive health domains.
  • the syndrome presents distinctive features, such as infertility, oligo/amenorrhea, hirsutism, acne, obesity, and the characteristic polycystic appearance of the ovaries. Beyond reproductive concerns, PCOS is associated with hyperandrogenism, insulin resistance, and cardiovascular complications, rendering the syndrome a substantial healthcare challenge.
  • the present disclosure provides a system for treating an ovary of a subject.
  • the system includes an ablation instrument, a laser emitter, an optical sensor, and a controller.
  • the ablation instrument includes a needle defining a lumen and an optical fiber fixedly received in the lumen of the needle.
  • a distal end of the optical fiber is disposed proximate to a distal tip of the needle.
  • the ablation instrument includes an ultrasound probe coupled to the needle.
  • the laser emitter is optically coupled to a proximal end of the optical fiber of the ablation instrument, and the laser emitter is configured to emit a low- power laser through the optical fiber to illuminate a target tissue of the ovary and a high- power laser through the optical fiber to ablate a predetermined volume of the target tissue of the ovary.
  • the optical sensor is configured to detect light reflected from the target tissue when illuminated by the low-power laser.
  • the controller is in electrical communication with the laser emitter and the optical sensor. [0014] In some aspects, the controller is configured to receive a signal transmitted by the optical sensor indicating optical spectral data of the target tissue.
  • the controller is configured to selectively actuate the laser emitter to emit the low-power laser to illuminate the target tissue and the high-power laser to ablate the target tissue of the ovary.
  • the controller is configured to adjust a parameter of the emitted high-power laser based on the optical spectral data of the target tissue.
  • the optical spectral data includes at least one of an optical absorption coefficient of the target tissue and optical scattering emissions of the target tissue.
  • the adjusted parameter of the emitted high-power laser includes at least one of laser pulse energy, laser pulse duration, repetition rate, and total delivered energy dose.
  • the laser emitter includes at least one of a laser diode, a semiconductor laser, a solid-state laser, and a light emitting diode.
  • the optical sensor includes at least one of a spectrometer, photoresistor, photodiode, and phototransistor.
  • the ablation instrument includes an adapter coupled to the needle and the ultrasound probe, wherein the adapter is configured to maintain the needle at a predetermined orientation with respect to the ultrasound probe such that the needle projects beyond the distal end of the ultrasound probe.
  • the laser emitter includes a first laser emitter optically coupled to the first optical fiber and configured to emit the low-power laser, and the laser emitter includes a second laser emitter optically coupled to the second optical fiber and configured to emit the high-power laser.
  • the controller is configured to determine a dimension of the target tissue based on the optical spectral data of the target tissue before actuating the laser emitter to emit the high-power laser to ablate the predetermined volume of the target tissue. [0025] In some aspects, after the high-power laser ablates the predetermined volume of the target tissue, the controller is configured to actuate the laser emitter to emit the low- power laser such that the ablated target tissue of the ovary is illuminated. In some aspects, the controller is configured to receive a signal transmitted by the optical sensor indicating optical spectral data of the ablated target tissue.
  • the controller is configured to determine a dimension of the ablated target tissue based on the optical spectral data of the ablated target tissue and a second predetermine volume of target tissue to be ablated by the high-power laser based on the dimension of the ablated target tissue.
  • the system further includes a thermal monitor in electrical communication with the controller.
  • the thermal monitor is configured to detect a temperature of the target tissue of the ovary.
  • the controller receives a signal transmitted by the thermal monitor indicating a temperature of the target tissue when treated by the high-power laser, and the controller is configured to adjust the parameter of the emitted high-power laser based on the temperature of the target tissue.
  • the controller is configured to photoacoustic monitor the target tissue using optical signals transmitted from the optical sensor and acoustic signals transmitted from the ultrasound probe.
  • the present disclosure provides a method for treating an ovary of a subject.
  • the method includes a step of inserting a needle with an optical fiber into the ovary of the subject using ultrasound visualization.
  • the method includes a step of illuminating, by a laser emitter emitting a low-power laser through the optical fiber, a first target tissue within the ovary.
  • the method includes a step of measuring, by an optical sensor optically coupled to the optical fiber, optical spectral data based on light reflected from the illuminated first target tissue.
  • the method includes a step of adjusting, by a controller in electrical communication with the optical sensor, a parameter of a high-power laser emitted by the laser emitter based on the optical spectral data of the illuminated first target tissue.
  • the method includes a step of ablating, by the laser emitter emitting the high-power laser according to the adjusted parameter, a predetermined volume of the first target tissue.
  • the method includes, after the step of measuring and before the step of adjusting: a step of determining a dimension of the target tissue based on the optical spectral data of the illuminated first target tissue.
  • the method includes, after the step of ablating: a step of illuminating, by the laser emitter emitting the low-power laser through the optical fiber, the ablated first target tissue within the ovary; measuring, by the optical sensor optically coupled to the optical fiber, optical spectral data based on light reflected from the illuminated ablated first target tissue; and determining whether to further ablate the ablated first target tissue or move the needle to a second target tissue within the ovary based on the optical spectral data of the illuminated ablated first target tissue.
  • the method includes, during the step of ablating: a step of monitoring, by a thermal monitor, a temperature of the first target tissue; and a step of determining, by the controller in electrical communication with the thermal monitor, whether to stop the laser emitter from emitting the high-power laser based on the monitored temperature.
  • the method includes, during the step of ablating: a step of receiving, by the controller, optic and acoustic signals corresponding to the first target tissue; and a step of photoacoustic monitor, by the controller, the first target tissue using the optic and acoustic signals corresponding to the first target tissue.
  • the spectral data includes at least one of an optical absorption coefficient of the target tissue and optical scattering emissions of the target tissue
  • the adjusted parameter of the high-power laser includes at least one of laser pulse energy, laser pulse duration, repetition rate, and total delivered energy dose.
  • FIG. 1 illustrates a schematic diagram of the ovarian treatment system according to an aspect.
  • FIG. 2 illustrates a perspective view of an ablation instrument according to an aspect.
  • FIG. 3 illustrates a side view of a needle assembly of the ablation instrument according to an aspect.
  • FIG. 4 illustrates a cross-sectional view of the needle assembly taken along line 4-4 of FIG. 3 according to an aspect.
  • FIG. 5 illustrates an enlarged view of a distal end of a needle taken along broken line 5-5 of FIG. 3 according to an aspect.
  • FIG. 6 illustrates a cross-section view of the distal end of the needle shown in FIG. 5 according to an aspect.
  • FIG. 7 illustrates a schematic diagram of a controller for the ovarian treatment system according to an aspect.
  • FIG. 8 illustrates a schematic diagram of an optical fiber of the ablation instrument treating a target tissue according to an aspect.
  • FIG. 9 illustrates a graph plotting an example spectrum of absorbance coefficient with respect to wavelength.
  • FIG. 10 illustrates a graph plotting an example spectrum of absorbance coefficient with respect to ablation depth.
  • FIG. 11 illustrates a block diagram showing aspects of a method of using the ovarian treatment system to treat an ovary of a subject according to an aspect.
  • distal end refers to an end of a component (e.g., a needle or an optical fiber) that is furthest from a clinician during use.
  • proximal end refers to an end of a component (e.g., needle or an optical fiber) opposite the distal end of the component or the end of the component nearest the clinician during use.
  • the term "subject” refers to any animal, including, but not limited to humans, non-human primates, mammals, veterinarian animals, and the like, which is to be the recipient of a particular treatment.
  • the subject is a human patient.
  • the subject is a human female that bears offspring or includes at least one ovary that produces ova.
  • optically coupled refers to a configuration in which two or more optical components are interconnected, directly or indirectly, such that light can be transmitted between them.
  • an ovarian treatment system of the present disclosure can overcome one or more of these deficiencies, for example, by including an ablation instrument having a needle to advance into the ovary and an optical fiber fixedly received in the needle to transmit a low-power laser to illuminate a target tissue within the ovary and a high-power laser to ablate the target tissue.
  • the ovarian treatment system includes an optical sensor measuring optical spectral data of the target tissue and a controller adjusting at least one parameter of the emitted high-power laser based on the optical spectral data of the target tissue.
  • FIG. 1 illustrates an ovarian treatment system 100 according to an aspect.
  • Ovarian treatment system 100 performs a therapeutic ablation procedure for treating subjects diagnosed with PCOS.
  • Ovarian treatment system 100 can precisely ablate a targeted tissue in the subject’s ovary with minimal invasiveness by adjusting the ablation treatment based on real-time spectral assessments, photoacoustic and ultrasound diagnostic signals, and dynamically adjusted laser emission parameters.
  • ovarian treatment system 100 can ablate a target tissue in each ovary of the subject, for example, by treating two ovaries of a human female subject.
  • Ovarian treatment system 100 can include an ablation instrument 200 to be introduced into the subject’s vaginal canal under ultrasound guidance.
  • Ablation instrument 200 can include a needle 210 to penetrate the subject’s ovary.
  • Ablation instrument 200 can include an optical fiber 220 to transmit a low-power laser to illuminate a target tissue in the ovary and a high-power laser to ablate a predetermined volume of the target tissue in the ovary of the subject.
  • Ovarian treatment system 100 can include a console 110 operatively coupled to ablation instrument 200.
  • console 110 can include a port 112 optically coupled to a proximal end of optical fiber 220 of ablation instrument 200.
  • Ovarian treatment system 100 can include a laser source, such as a laser emitter 120, to emit the low-power laser and the high-power laser through optical fiber 220 of ablation instrument 200.
  • laser emitter 120 can be housed in console 110 and optically coupled to optical fiber 220 via port 112 or an optical connector of console 110.
  • laser emitter 120 can be located proximate to a proximal end of optical fiber 220 and optically coupled to the proximal end of optical fiber 220.
  • Ovarian treatment system 100 can include any component suitable for establishing an optical path between laser emitter 120 and optical fiber 220, such as a fiber optic connector.
  • Ovarian treatment system 100 can include an optical sensor 130 to detect light emitted by the low-power laser and light reflected from the target tissue.
  • optical sensor 130 can be housed in console 110 and optically coupled to optical fiber 220 via port 112 of console 110.
  • optical sensor 130 can be located proximate to the proximal end of optical fiber 220 and optically coupled to the proximal end of optical fiber 220.
  • optical sensor 130 can be located proximate to a distal end of optical fiber 220 and optically coupled to the distal end of optical fiber 220.
  • optical sensor 130 can be included with ablation instrument 200.
  • Ovarian treatment system 100 can include any component suitable for establishing an optical path between optical sensor 130 and optical fiber 220, such as a fiber optic connector.
  • Ovarian treatment system 100 can include a controller 140 in electrical communication with laser emitter 120 and optical sensor 130.
  • controller 140 can be housed in console 110 and electrically coupled to laser emitter 120 and optical sensor 130.
  • Controller 140 can receive a signal transmitted by optical sensor 130 indicating optical spectral data of the target tissue.
  • Controller 140 can selectively actuate laser emitter 120 to emit the low-power laser to illuminate the target tissue and the high-power pule laser to ablate the target tissue of the ovary.
  • Controller 140 can adjust a parameter of the emitted high-power laser based on the optical spectral data of the target tissue.
  • FIG. 2 illustrates ablation instrument 200 according to an aspect.
  • Ablation instrument 200 can include an ultrasound probe 230.
  • Ultrasound probe 230 can be in electrical communication with a display to provide ultrasound images of subject’s ovary and target tissue.
  • ultrasound probe 230 can be in electrical communication with a clinician’s ultrasound system that is operatively distinct from ovarian treatment system 100.
  • ultrasound probe 230 can be in electrical communication with console 110 of ovarian treatment system 100. Continuous, high- resolution ultrasound imaging provides precise visualization of ovarian tissues, allowing the clinician to accurately guide and position needle 210 toward the targeted ovarian region.
  • ultrasound probe 230 can include a piezoelectric transducer (PZT) ultrasound, Optical Ultrasound (OpUS), and/or other ultrasound-based fiber systems suitable for emitting and receiving acoustic waves to generate images of the ovarian tissues.
  • PZT piezoelectric transducer
  • OpUS Optical Ultrasound
  • other ultrasound-based fiber systems suitable for emitting and receiving acoustic waves to generate images of the ovarian tissues.
  • Ablation instrument 200 can include a needle assembly 202 coupled to ultrasound probe 230.
  • needle assembly 202 is integrated with ultrasound probe 230 such the needle 210 and ultrasound probe 230 are joined as one-piece.
  • ablation instrument 200 can include an adapter removably coupled to the needle assembly 202 and ultrasound probe 230 such that needle assembly 202 and ultrasound probe 230 are coupled together as separate pieces.
  • Adapter can maintain needle 210 at a predetermined orientation with respect to ultrasound probe 230 such that needle 210 projects beyond the distal end of ultrasound probe 230.
  • adapter can include any structure suitable for coupling needle assembly 202 to ultrasound probe 230, such as a clamp ring
  • needle assembly 202 can include needle 210 that receives a distal portion of optical fiber 220.
  • needle assembly 202 can include a protective outer sleeve 240 received over a segment of optical fiber 220 to allow a user to handle optical fiber 220 without directly manipulating optical fiber 220.
  • Needle assembly 202 can include a strain relief 242 coupled to an end of outer sleeve 240 to protect optical fiber 220 from excessive bending caused by axial loads.
  • Needle assembly 202 can include a mandrel 244 received over a segment of optical fiber 220 and received in strain relief 242 to secure optical fiber 220 to strain relief 242 and outer sleeve 240.
  • needle 210 can define a lumen 214 extending from an open distal tip 212 of needle 210 through an open proximate end of needle 210.
  • Optical fiber 220 is fixedly received in lumen 214 of needle 210 such that the optical fiber 220 does not move along lumen 214 of needle 210.
  • needle 210 can be fixedly received in lumen 214 of needle 210 via an interference fit formed between lumen 214 of needle 210 and optical fiber 220.
  • lumen 214 of needle 210 can include a threaded interior surface.
  • Optical fiber 220 can include a jacket (e.g., jacket 224 shown in FIG.
  • needle 210 and optical fiber 200 eliminates the use of deployable therapeutic components, such as electrodes and anchoring devices.
  • the fixed relationship between needle 210 and optical fiber 220 ensures consistent and predictable optical performance throughout an entire ablation procedure.
  • distal tip 212 of needle 210 defines an opening 216 having a diameter in a range from 16 gauge to 22 gauge, for example, preferably in a range from 17 gauge to 20 gauge, such as 18 gauge (i.e., 0.85 mm).
  • Providing opening 216 of distal tip 212 in a range from 16 gauge to 22 gauge allows needle 210 to penetrate the subject’s ovary with a less traumatic approach and procedural invasiveness while maintaining sufficient sizing for optical fiber 220 to effectively transmit the low-power laser and high- power laser.
  • the size of distal tip 212 and opening 216 reduces the need for general anesthesia and subject discomfort, ultimately expediting post-procedural recovery time.
  • distal end 222 of optical fiber 220 is located proximate to distal tip 212 of needle 210.
  • Distal tip 212 of needle 210 projects beyond distal end 222 of optical fiber 220 to allow needle 210 to penetrate the subject’s ovary with less discomfort.
  • opening 216 of distal tip 212 exposes distal end 222 of optical fiber 220.
  • needle 210 can include a protective glass endcap for enclosing opening 216 or a microlenses located at opening 216 to beam shape the lasers transmitted through optical fiber 220, for example, to meet clinical and therapeutic requirements.
  • the glass endcap and/or microlenses can tune the direction and/or amount of laser radiation that is emitted from distal end 222 of optical fiber 220.
  • optical fiber 220 can be attached to an end cup at distal tip 212 of needle 210 to create space and solid environment for ablation. The end cup will be attached to the distal tip 212 of needle 210.
  • ablation instrument 200 can include an optical lens or other optical components located at or adjacent to distal end 222 of optical fiber 220 to focus or diffuse the emitted laser beam.
  • Optical fiber 220 can include a transparent core surrounded by an opaque or transparent cladding material having a lower index of refraction than the core material. A light transmission is maintained within the core by total internal reflection.
  • Optical fiber 220 can include a single fiber having a single fiber core or a fiber bundle of two or more fibers maintained in a core defined by the cladding material.
  • Optical fiber 220 can aim the lasers in a predetermined direction.
  • Optical fiber 220 can transmit the low-power laser to illuminate and receive light reflected by the target tissue to help controller 140 determine the coefficient absorbance of the tissue.
  • Optical fiber 200 can transmit the high-power laser to ablate the target tissue. Accordingly, optical fiber 220 can operate in multimodes: a diagnostic feedback mode when transmitting the low-power laser and a therapeutic mode when transmitting the high-power laser.
  • optical fiber 220 can be implemented as multiple optical fibers such that each optical fiber is directed to a particular mode of operation.
  • optical fiber 220 can include a first optical fiber and a second optical fiber that are received in lumen 214 of needle 210.
  • the distal end of the first and second optical fibers can be located proximate to distal tip 212 of needle 210, for example, similar to the arrangement shown in FIGS. 4 and 5.
  • the first and second optical fibers can each operate only in a single mode.
  • the first optical fiber can be optically coupled to laser emitter 120 to maintain transmission of the low-power laser through distal tip 212 of needle 210.
  • the first optical fiber can include multiple first optical fibers such that multiple optical fibers in ablation instrument 200 are configured to illuminate the target tissue for diagnostic monitoring. Directed to transmitting the low-power laser, the first optical fiber serves exclusively to provide realtime monitoring and feedback for the ablation procedure. In doing so, the first optical fiber allows real-time tissue detection and monitoring methodologies, notably photoacoustic monitoring/imaging and all-optical ultrasound detection. Integration of this diagnostic fiber allows continuous, precise acquisition of acoustic and optical signals, dynamically reflecting tissue changes, lesion size and depth, and temperature distribution within the ablated regions, significantly enhancing procedural precision, efficacy, and subject safety.
  • the second optical fiber can be optically coupled to laser emitter 120 to maintain transmission of the high-power laser through the distal tip 212 of needle 210. Directed to transmitting the high-power laser, the second optical fiber serves exclusively to provide therapeutic treatment of the ovarian tissue.
  • the second optical fiber can include multiple second optical fibers such that multiple optical fibers in ablation instrument 200 are configured to ablate the target tissue.
  • laser emitter 120 can include a laser diode, a semiconductor laser, a solid-state laser, and/or a light emitting diode.
  • laser emitter 120 can include a laser diode that emits high-power laser energy and low power laser energy in pulsed and/or continuous modes, thereby delivering highly controllable and adjustable energy output.
  • Parameters of the laser diode in laser emitter 120 such as pulse energy, duration, repetition rate, and total delivered dose, can be can be dynamically modulated during the procedure, informed by real-time, tissue-specific spectral characterization.
  • the low-power laser refers to a laser beam emitted in a power range, such as, for example, 0.5 W to 1.0 W, that is suitable for illuminating the target tissue without ablating the target tissue.
  • the low-power laser can have a wavelength, in a range from 980 nm to 1470 nm.
  • the low-power laser can be in any wavelength that can provide an estimation of the tissue properties that are related to the ablation procedure.
  • the low-power laser can have the same wavelength as the high-power laser.
  • laser emitter 120 can emit the low-power laser in a continuous mode, a pulsed mode, and/or a modulated pulse mode. For example laser emitter 120 can emit a low-power continuous laser to illuminate the target tissue.
  • the high-power laser refers to a laser beam emitted in a power range, such as, for example, 0.5 W to 30.0 W, preferably from 10.0 W to 20.0 W, that is suitable for ablating the target tissue.
  • the high-power laser can have a wavelength in a range from 445 nm to 2000 nm, for example laser emitter 120 can emit the high-power laser with a wavelength of 980 nm, 1064 nm, 1350 nm, 1470 nm, 1535 nm, 1870 nm, or 2000 nm.
  • laser emitter 120 can emit the high-power laser in a continuous mode, a pulsed mode, and/or a modulated pulse mode.
  • laser emitter 120 can emit a high-power pulse laser to ablate the target tissue.
  • laser emitter 120 can include multiple laser emitters such that each laser emitter is directed to one particular mode of operation.
  • laser emitter 120 can include a first laser emitter optically coupled to the first optical fiber. The first laser emitter is configured to emit the low-power laser through the first optical fiber to illuminate the target tissue.
  • Laser emitter 120 can include a second laser emitter optically coupled to the second optical fiber. The second laser emitter is configured to emit the high-power laser through the second optical fiber to ablate the target tissue.
  • the ovarian treatment system can include other forms of energy commonly used for ablation, including radiofrequency (RF) energy, microwave energy, ultrasound-based high-intensity focused ultrasound (HIFU), and cryotherapy-based.
  • RF radiofrequency
  • HIFU ultrasound-based high-intensity focused ultrasound
  • Optical sensor 130 can measure an optical absorption coefficient of the illuminated target tissue by measuring the intensity of the light reflected by the low- power laser illuminating the target tissue.
  • Optical sensor 130 can measure the light scattering properties of the illuminated target tissue, for example, by using spectroscopy principles.
  • optical sensor 130 can include a spectrometer, photoresistor, photodiode, and/or phototransistor.
  • optical sensor 130 can include an array of photodiodes or other types of photodetectors (e.g., a matrix of detectors or a detector for each axis of the image) to convert the received optical signals to an image of the target tissue.
  • optical sensor 130 can include a spectrometer optically coupled to the proximal end of optical fiber 220.
  • the spectrometer can include any component suitable for measuring and quantifying the spectral content of light transmitted through optical fiber 220, such as, for example, an entrance slit, collimating optics, a diffraction grating or prism, an optic filter, a charge-coupled device and/or metal-oxide semiconductor sensor array.
  • ovarian treatment system 100 can include a thermal monitor 150 in electrical communication with controller 140.
  • Thermal monitor 150 can detect a temperature of the target tissue of the subject’s ovary in real-time, including during a pre-diagnostic mode of operation (e.g., when the target tissue is illuminated by low-power laser before ablation) and a therapeutic mode of operation (e.g., when the target tissue is ablated by the high-power laser).
  • Thermal monitor 150 can transmit signals to controller 140 indicating a temperature of the target tissue.
  • thermal monitor 150 can employ Fiber Bragg Grating (FBG-based) sensor that detects changes of refractive indices in optical fiber 220 or another optical fiber (e.g., a 50 pm fiber with FBG) that is proportional to a change in temperature of the target tissue.
  • FBG-based Fiber Bragg Grating
  • thermal monitor 150 can include other types of sensors to detect a temperature of the target tissue, such as a thermocouple or infrared (IR) technology.
  • controller 140 can receive input signals via electrical communication (e.g., wired or wireless communication) from optical sensor 130, thermal monitor 150, and/or ultrasound probe 230. Controller 140 can transmit output signals via electrical communication (e.g., wired or wireless communication) to laser emitter 120. Controller 140 can receive output signals from and transmit output signals via electrical communication (e.g., wired or wireless communication) to a graphical user interface (GUI) 114.
  • GUI 114 can be displayed on console 110 or externally on a computer or tablet, allowing clinicians to visually monitor tissue status, lesion geometry, ablation progress, and thermal distributions throughout the ablation treatment procedure. GUI 114 can also allow clinicians to manually intervene or adjust parameters as clinically indicated, ensuring both procedural flexibility and comprehensive clinical oversight.
  • controller 140 can include a processor (e.g., a microprocessor, a multi-core processor, a central processing unit) configured to receive input signals from graphical user interface 114, optical sensor 130, thermal monitor 150, and/or ultrasound probe 230. Controller 140 can generate output signals transmitted to laser emitter 120 to adjust operating parameters of the emitted laser, such as laser pulse energy, duration, repetition rate, and total delivered energy dose. Controller 140 can include memory comprising computer storage media in the form of volatile memory, such as random access memory (RAM), and/or nonvolatile memory, such as read only memory (ROM).
  • RAM random access memory
  • ROM read only memory
  • controller 140 can store computer readable instructions, data structures, program modules, other data, and proprietary software modules for executing computational algorithms and real-time control logic, which are inputted to the processor for the execution of operations, as described herein.
  • Controller 140 can include any type of circuitry components, such as a bus, for transmitting instructions stored in the memory to the processor.
  • controller 140 can implement optical sensor 130 and ultrasound probe 230 or another acoustic sensor of ovarian treatment system 100 to generate photoacoustic monitoring/imaging of the target tissue.
  • controller 140 can receive optical signals from optical sensor 130 and acoustic signals from ultrasound probe 230 or another acoustic sensor (e.g., piezoelectric transducer).
  • the acoustic signals inputted to controller 140 can be generated by the low-power laser illuminating the target tissue and/or the high-power laser ablating the target tissue.
  • Controller 140 can include one or more algorithms to generate images depicting the distribution of the light absorbing molecules on the target tissue, which can be distinguished based on their absorption characteristics. Unlike images generated by ultrasound, photoacoustic monitoring and images generated by controller 140 reveals optical resolution of the target tissue with the acoustic penetration depth, thereby providing functional and structural information (e.g., higher resolution of micro-sized depths and crevices) not conveyed by ultrasound images.
  • the photoacoustic monitoring and/or images and other extracted tissue data generated by controller 140 is simultaneously transmitted to a dedicated secondary display (e.g., GUI 114 on console 110), where it is synthesized alongside the ultrasound imaging data exported directly from the clinic’s ultrasound system. While the physician's primary ultrasound screen remains unchanged, this integrated secondary display (e.g., GUI 114) can serve as the central processing hub, where controller 140 continuously analyze and translate the combined tissue and imaging information.
  • Critical parameters including laser pulse energy, duration, repetition rate, and total delivered energy dose, are dynamically determined and continuously optimized, by controller 140, throughout the procedure, allowing personalized, targeted, and safe therapeutic intervention.
  • controller 140 can selectively actuate laser emitter 120 to emit the low-power laser and the high-power laser based on inputs from optical sensor 130, thermal monitor 150, ultrasound probe 230 according to a plurality modes of operation, including a pre-ablation diagnostic mode, an intra-ablation real-time monitoring ablation mode, and a post-ablation feedback.
  • controller 140 When controller 140 is operating in the pre-ablation diagnostic mode, controller 140 actuates laser emitter 120 to emit the low-power laser through optical fiber 220 to illuminate the first target tissue of the subject’s ovary. In some aspects, controller 140 actuates laser emitter 120 to emit the low-power laser in a continuous mode, a pulsed mode, and/or a modulated pulse mode. During pre-ablation diagnostic mode, controller 140 characterizes the optical properties (e.g., absorption) of the target tissue and uses that data (e.g., the optical properties) to calibrate laser emitter 120 and/or adjust parameters of the emitted lasers.
  • optical properties e.g., absorption
  • optical sensor 130 e.g., a spectrometer
  • optical sensor 130 can transmit a signal to controller 140 indicating the optical spectral data of the target tissue.
  • controller 140 can determine: (a) whether or not to ablate the target tissue (e.g., due to being at a wrong tissue such as a cyst, or due to any other pathological reason); (b) whether to adjust the parameters (e.g., power, pulse duration, time duration, etc.) of the high-power laser; or (c) whether there is enough information to determine the parameters of the high-power laser.
  • controller 140 can use the spectral data to plot the differences with absorbance coefficient at different locations at the same tissue, as shown in FIG. 9, and then, determine a dimension of the target tissue, such as lesion size and depth, based on the plotted absorbance coefficients.
  • controller 140 can determine one or more parameters, including laser pulse energy, duration, repetition rate, and power, of the high-power laser to ablate the target tissue based on the optical spectral data.
  • the high-power laser can be adjusted to be emitted in a power range from .5 W to 30.0 W (e.g., 10 W) and in a wavelength range from 445 nm to 2000 nm (e.g., 1470 nm).
  • the high-power laser can be emitted with a frequency of 1000 Hz and a pulse duration of 100 micro-second.
  • controller 140 can actuate laser emitter 120 to emit the high-power laser to ablate a predetermined volume of the target tissue.
  • controller 140 can actuate laser emitter 120 to emit the high-power laser in a continuous mode, a pulsed mode, and/or a modulated pulse mode.
  • controller 140 can detect the temperature and/or temperature distribution of the target tissue based on signals transmitted by thermal monitor 150.
  • Controller 140 can actuate laser emitter 120 to stop the high-power laser when the monitored temperature of the target tissue reaches above a threshold temperature that could burn the subject’s ovary.
  • controller 140 can continue to characterizes the optical properties (e.g., absorption) of the target tissue, using the same or similar spectral analysis executed during the pre-ablation mode, to detect depth and lesion of the ablated target tissue, thereby providing feedback to clinician during ablation.
  • optical properties e.g., absorption
  • controller 140 can receive optical signals from optical sensor 130 and acoustic signals from ultrasound probe 230 or another acoustic sensor to monitor characteristics of the target tissue. For example, controller 140 can actuate the first optical fiber to emit the low- power laser while the second optical fiber is emitting the high-power laser to ablate the target tissue, and the first optical fiber can transmit light reflected from the target tissue to optical sensor 130. Receiving signals indicating optical spectral data of the target tissue, controller 140 can determine the difference of the absorbance coefficient of the target tissue before and during ablation. Controller 140 can determine tissue properties based on the differences in absorbance coefficient.
  • controller 140 Continuously monitoring optical, acoustic, and temperature data in real-time during ablation, controller 140 provides immediate, precise feedback regarding lesion formation, depth and boundary integrity, thermal distribution, and evolving tissue morphology.
  • the dimensions of the ablation will be determined in real-time also by impedance, indicating the depth and size of the ablation, and the parameters of the high-power laser can be tuned automatically or manually based on the real-time feedback.
  • real-time refers to the actual time that an event occurs and corresponds to input data being processed within milliseconds so that the data is available immediately as feedback.
  • controller 140 can generate a photoacoustic image of the first target tissue in real-time using optic and acoustic signals reflected by the target tissue.
  • the photoacoustic monitoring and images allow a clinician to identify tissue changes indicative of the procedure's progress, which further enhances the accuracy, safety, and effectiveness of the treatment.
  • controller 140 when controller 140 is operating in the post-ablation feedback mode, controller 140 can actuate laser emitter 120 to emit the low-power laser such that optical sensor 130 can re-measure the optical spectral data of the ablated target tissue. Receiving a signal from optical sensor 130, controller 140 can determine whether further ablation of the target tissue is needed based on the optical spectral data of the ablated target tissue. Controller 140 can determine new parameters for the high-power laser to account for the altered tissue properties. Controller 140 can then actuate laser emitter 120 to emit the high-power laser according to the updated parameters. In some aspects, the feedback can be implemented in a duty cycle or in parallel.
  • ovarian treatment system 100 will avoid: (a) burning of the tissue (e.g., raising the temperature of the target tissue above a temperature threshold), (b) over-ablation (e.g., ablating more than a predetermined volume of the ovarian tissue); and (c) insufficient ablation (e.g., ablating less than a predetermined volume of ovarian tissue).
  • Controller 140 can calculate the size and depth to be ablated, for example, creating scar tissue of up to a predetermined volume, such as 10.1 mm 3 .
  • needle 210 can be moved to the second target tissue determined by a clinician or controller 140.
  • FIG. 11 illustrates an example method 300 of treating an ovary of the subject, particularly treatment for PCOS, using ovarian treatment system 100 described herein.
  • method 300 can be used to treat one ovary or two ovaries of a human female subject.
  • method 300 can include a step 310 of inserting needle 210 with optical fiber 220 into an ovary of the subject using ultrasound visualization.
  • a step 310 of inserting needle 210 with optical fiber 220 into an ovary of the subject using ultrasound visualization For example, visualization of the needle’s position can be confirmed by ultrasound images generated by ultrasound probe 230, thereby allowing needle 210 to be carefully advanced into the ovary.
  • a clinician can facilitate movement of needle 210 by handling ablation instrument 200.
  • method 300 can include one or more steps to provide preablation diagnostic analysis of the target tissue.
  • method 300 can include a step 320 of illuminating a first target tissue within the ovary by using laser emitter 120 to emit the low-power laser through optical fiber 220.
  • step 320 can include controller 140 actuating the laser emitter 120 to emit the low-power laser.
  • step 320 can include transmitting the low-power laser through the first optical fiber. Step 320 can occur after confirming that needle 310 is placed at an operative location with respect to the target tissue using ultrasound guidance.
  • Method 300 can include a step 330 of measuring, by optical sensor 130, optical spectral data based on light reflected from the illuminated first target tissue.
  • the optical spectra data includes an optical absorption coefficient of the target tissue and optical scattering emissions of the target tissue.
  • method 300 can include a step 340 of adjusting, by controller 140 in electrical communication with optical sensor 130, a parameter of the high-power laser emitted by the laser emitter based on the optical spectral data of the illuminated first target tissue.
  • the parameter can include at least one of laser pulse energy, laser pulse duration, repetition rate, and total delivered energy dose.
  • method 300 can include a step of determining a dimension of the target tissue, such as lesion size and depth, based on the optical spectral data of the illuminated first target tissue.
  • method 300 can include a step 350 of ablating a predetermined volume of the first target tissue by using laser emitter 120 to emit the high-power laser according to the adjusted parameter.
  • step 350 can include transmitting the high-power pulse layer through optical fiber 220.
  • step 350 can include transmitting the high-power pulse layer through the second optical fiber.
  • step 350 can include one or more monitoring procedures to provide real-time feedback during the ablation of the target tissue.
  • step 350 can include monitoring a temperature of the target tissue using thermal monitor 150.
  • Step 350 can include determining, by controller 140, whether to stop laser emitter 120 from the emitting the high-power pulse layer based on the monitored temperature
  • step 350 can include receiving, by controller 140, optic and acoustic signals corresponding to the target tissue.
  • Step 350 can include photoacoustic monitoring, by controller 140, the first target tissue using the optic and acoustic signals corresponding to the target tissue.
  • method 300 can include one or more steps to provide postablation feedback.
  • method 300 can include a step 360 of illuminating the ablated first target tissue within the ovary using emitter 120 to emit the low-power laser through optical fiber 220.
  • step 360 can include using the first optical fiber to transmit the low-power laser.
  • method 300 can include a step 370 of determining whether further ablation of the first target tissue is needed.
  • Step 370 can be determined based on applying optical spectral data received from optical sensor 130 according to one or more stored algorithms in the memory of controller 140.
  • controller 140 can determine if another ablation step is needed based on a comparison between the volume of the ablated tissue and the desired volume of ablated tissue: where A is the volume of the ablation in one step and V is the wanted ablation volume and i is the steps (the effect happens when the fiber moving backwards small step to get the wanted volume).
  • method 300 can include a step 380 of moving needle 210 to a second target tissue within the ovary of the subject if further ablation of the first target tissue is not needed.
  • multiple ablations can be performed according to steps 310 to 390 within the same ovary of the subject or in both ovaries of the subject.
  • using ovarian treatment system 100 according to method 300 can form multiple ablation points (e.g., 3 or 4) across the ovarian tissue rather than just one.
  • method 300 include a step 390 of repeating steps 340 to 370 if further ablation of the first target tissue is needed.
  • method 300 can include a step of advancing and/or retracting needle 310 in a linear motion to control the accuracy of the laser emission.
  • optical fiber 220 can be retracted away from a target tissue 10 by a predetermined distance (e.g., 1 to 5 millimeters) after completing its first ablation step (e.g., step 350).
  • Executing steps 310 to 390 of method 300 can mitigate the symptoms and complications caused by PCOS, such as infertility, miscarriages, sleep apnea, oligo/amenorrhea, hirsutism, acne, obesity, and the polycystic appearance of the ovaries. Furthermore, using ovarian treatment system 100 according to method 300 can treat PCOS symptoms beyond infertility, including hormonal imbalance, ovarian volume reduction, and overall metabolic and endocrine improvement.

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Abstract

L'invention concerne un système de traitement d'une ovaire d'un sujet comportant un instrument d'ablation, un émetteur laser, un capteur optique et un dispositif de commande. L'instrument d'ablation comprend une aiguille, une fibre optique et une sonde ultrasonore. L'émetteur laser émet un laser à faible puissance servant à éclairer un tissu cible de l'ovaire et un laser à haute puissance servant à réaliser une ablation du tissu cible de l'ovaire. Le dispositif de commande règle un paramètre du laser à haute puissance sur la base d'une rétroaction provenant du capteur optique.
PCT/IB2025/053800 2024-04-11 2025-04-10 Systèmes d'ablation laser dans les ovaires à l'aide d'une rétroaction d'ajustement de tissu Pending WO2025215589A1 (fr)

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Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20220022960A1 (en) * 2020-07-21 2022-01-27 Gyrus Acmi, Inc. D/B/A Olympus Surgical Technologies America Laser treatment using acoustic feedback
CN116172695B (zh) * 2023-03-02 2024-03-01 哈尔滨工业大学（威海） 一种介入式血管内多模态成像及消融一体化导管
EP4342407A1 (fr) * 2022-09-23 2024-03-27 Terra Quantum AG Système laser et procédé de détection et de traitement d'informations

Patent Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20220022960A1 (en) * 2020-07-21 2022-01-27 Gyrus Acmi, Inc. D/B/A Olympus Surgical Technologies America Laser treatment using acoustic feedback
EP4342407A1 (fr) * 2022-09-23 2024-03-27 Terra Quantum AG Système laser et procédé de détection et de traitement d'informations
CN116172695B (zh) * 2023-03-02 2024-03-01 哈尔滨工业大学（威海） 一种介入式血管内多模态成像及消融一体化导管

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