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WO2024110646A1 - Système chirurgical - Google Patents

Système chirurgical Download PDF

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Publication number
WO2024110646A1
WO2024110646A1 PCT/EP2023/083033 EP2023083033W WO2024110646A1 WO 2024110646 A1 WO2024110646 A1 WO 2024110646A1 EP 2023083033 W EP2023083033 W EP 2023083033W WO 2024110646 A1 WO2024110646 A1 WO 2024110646A1
Authority
WO
WIPO (PCT)
Prior art keywords
laser beam
image data
control system
medical image
several
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.)
Ceased
Application number
PCT/EP2023/083033
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English (en)
Inventor
Daniel Beer
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.)
Advanced Osteotomy Tools AOT AG
Original Assignee
Advanced Osteotomy Tools AOT AG
Priority date (The priority date 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 date listed.)
Filing date
Publication date
Application filed by Advanced Osteotomy Tools AOT AG filed Critical Advanced Osteotomy Tools AOT AG
Publication of WO2024110646A1 publication Critical patent/WO2024110646A1/fr
Anticipated expiration legal-status Critical
Ceased legal-status Critical Current

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B34/00—Computer-aided surgery; Manipulators or robots specially adapted for use in surgery
    • A61B34/10—Computer-aided planning, simulation or modelling of surgical operations
    • 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
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B34/00—Computer-aided surgery; Manipulators or robots specially adapted for use in surgery
    • A61B34/30—Surgical robots
    • 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
    • A61B18/201—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 with beam delivery through a hollow tube, e.g. forming an articulated arm ; Hand-pieces therefor
    • 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
    • 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
    • A61B2018/00321—Head or parts thereof
    • A61B2018/00327—Ear, nose or throat
    • 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
    • A61B2018/00565—Bone
    • 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
    • A61B2018/00904—Automatic detection of target tissue
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B34/00—Computer-aided surgery; Manipulators or robots specially adapted for use in surgery
    • A61B34/10—Computer-aided planning, simulation or modelling of surgical operations
    • A61B2034/101—Computer-aided simulation of surgical operations
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B34/00—Computer-aided surgery; Manipulators or robots specially adapted for use in surgery
    • A61B34/10—Computer-aided planning, simulation or modelling of surgical operations
    • A61B2034/107—Visualisation of planned trajectories or target regions
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B34/00—Computer-aided surgery; Manipulators or robots specially adapted for use in surgery
    • A61B34/25—User interfaces for surgical systems
    • A61B2034/252—User interfaces for surgical systems indicating steps of a surgical procedure
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B34/00—Computer-aided surgery; Manipulators or robots specially adapted for use in surgery
    • A61B34/30—Surgical robots
    • A61B2034/301—Surgical robots for introducing or steering flexible instruments inserted into the body, e.g. catheters or endoscopes
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B34/00—Computer-aided surgery; Manipulators or robots specially adapted for use in surgery
    • A61B34/25—User interfaces for surgical systems
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B34/00—Computer-aided surgery; Manipulators or robots specially adapted for use in surgery
    • A61B34/30—Surgical robots
    • A61B34/32—Surgical robots operating autonomously

Definitions

  • the present invention relates to a surgical system according to the preamble of independent claim 1 and more particularly to a surgical system that comprises a robot arm.
  • the present invention also relates to a control method for such a surgical system.
  • Such a surgical system can be used for selectively removing hard tissue such as bone.
  • hard tissue as used in the context of the invention can relate to a tissue which is mineralized and/or has a firm intercellular matrix.
  • the hard tissue can particularly be bone tissue and/or cartilage tissue or similar.
  • an electromechanical tool for removing hard tissue may be associated with undesirable effects.
  • a surface of the non-removed hard tissue may be modified in a manner which may slow down the healing process.
  • the mechanical stress applied by the electromechanical tool may be unsuitable for accessing some of the delicate structures in a skull.
  • the invention is a surgical system comprising a surgical tool, a robot arm on which the surgical tool is arranged, and a control system configured to operate the robot arm and the surgical tool, and to receive medical image data of a subject, wherein the medical image data represents a volume containing at least part of a skull or temporal bone of the subject.
  • the surgical tool comprises a laser beam generator configured to emit a laser beam to ablate hard tissue.
  • the control system is configured to evaluate the medical image data and to use the evaluated image data to cause the laser beam generator to emit the laser beam impinging on a mastoid portion of the temporal bone.
  • the surgical system is configured in such a manner that it can remove hard tissue in a mastoid portion by way of laser ablation.
  • the position and operation of the laser beam generator is controlled by the control system, using results of an image evaluation. High accuracy and precision in hard tissue ablation is attained thereby.
  • the surgical system does not exert mechanical stress neither on hard tissue of the mastoid portion that is not ablated, allowing the adverse effects of electromechanical tools to be avoided.
  • the surgical system is also less prone to damaging soft tissue, in contrast to mechanical systems that are prone to mechanically damaging soft tissue in proximity to a trajectory along which hard tissue ablation is performed.
  • the surgical system is configured for use in specific procedures such as an antrostomy, a mastoidectomy, and/or a tympanotomy.
  • the hard tissue may be tissue which is mineralized and/or has a firm intercellular matrix.
  • the hard tissue may be bone tissue and/or cartilage tissue or similar.
  • control system is configured to cause the laser beam generator to ablate the hard tissue of the mastoid portion to perform one, several, or all of: an antrostomy; a mastoidectomy; templating for a mastoidectomy; a tympanotomy; forming extended 3D, 2D, or 1 D incisions along sensitive structures.
  • the ablation is preferably performed within, and limited to, a volume within the hard tissue which is spaced from all delicate tissue (such as nerve or vascular tissue or other delicate tissue) by at least a safety margin distance.
  • volumetric tissue removal and/or the formation of one or several cuts is attained using laser ablation for performing specific interventions.
  • Antrostomy, mastoidectomy, and/or tympanotomy are particularly suitable for being performed using a laser beam generator positioned by a robot arm and controlled using the evaluated image data.
  • critical regions such as a facial nerve
  • laser beam generator operation allowing the surgical system to ensure that such regions remain unaffected by the laser beam ablation.
  • the surgical system is configured to ablate tissue that comprises hard tissue without being limited to hard tissue.
  • the system is capable of removing combinations of hard tissue and, e.g., cancerous tissue.
  • the hard tissue ablated by the laser beam is or comprises a conical or frustoconical volume of the bone tissue.
  • Laser ablation makes it possible to efficiently and accurately form conical or frustoconical passages in the mastoid portion, which are particularly suitable for, e.g., inserting an electrode of a hearing assistance system (such as a cochlea implant system) or another elongate object such as an endoscope through the mastoid portion.
  • a hearing assistance system such as a cochlea implant system
  • another elongate object such as an endoscope
  • control system is configured to determine a geometry of at least part of a cochlea of the subject and to use the determined geometry to control a beam axis of the laser beam.
  • control system is configured to control the beam axis relative to a tangent to the cochlea.
  • control system is configured to segment the medical image data to detect one or several surfaces of the mastoid portion and to use the detected one or several surfaces to control the laser beam generator.
  • the one or several surfaces comprise a surface at a tympanic antrum and/or a sulcus tympanicus.
  • the laser beam may be controlled in such a manner that it does not perform laser ablation beyond the mastoid surface at the tympanic antrum and/or the sulcus tympanicus. Safety is enhanced by using the image segmentation.
  • control system is configured to use the detected one or several surfaces to control the laser beam generator to ensure a spacing between the laser beam and each of the one or several surfaces.
  • the spacing is adjustable by an input enabled by a user interface.
  • the control system is configured to use the segmented image data to discriminate an interior surface defining a mastoid cell from a surface of the mastoid portion that does not delimit a mastoid cell.
  • mast cell refers to a pneumatic cell within the mastoid portion in the art.
  • the surgical system comprises a safety mechanism that switches off or blanks the laser beam, and wherein the control system is configured to selectively override the safety mechanism in response to confirming that the laser beam reaches the interior surface while being spaced from the surfaces of the mastoid portion that do not delimit a mastoid cell.
  • Safety is further enhanced by providing the safety mechanism that switches off or blanks the laser beam by default when a surface of hard tissue is reached and that is selectively overridden in response to confirming that the surface is an internal surface within the mastoid portion, which delimits a mastoid cell.
  • the surgical system preferably comprises a user interface configured to receive input specifying one or several prohibited regions relative to a graphical representation of the medical image data, wherein the control system is configured to use the evaluated image data to prevent the laser beam from impinging onto the one or several prohibited regions.
  • Safety is further enhanced by providing a user interface that allows prohibited regions to be defined, while implementing an automatic mechanism of avoiding such prohibited regions.
  • the control system may be operative such that the prohibited regions include nerve tissue, in particular a facial nerve.
  • the one or several prohibited regions are regions which contain delicate tissue, in particular soft tissue.
  • the one or several prohibited regions may be regions in which soft tissue of the nerval or vascular system are disposed.
  • the control system is configured to use the evaluated image data to prevent the laser beam from passing through a volume located within a safety margin distance around any of the one or several prohibited regions.
  • Safety is further enhanced by ensuring that a safety margin distance around any of the prohibited regions is ensured, to prevent the laser beam from passing closer than the safety margin distance along any of the prohibited regions.
  • the surgical system may allow the safety margin distance to be adjusted, thereby providing enhanced controllability.
  • the user interface is configured to receive additional input specifying a target and the control system is configured to use the evaluated image data to identify a trajectory for the laser beam to the target such that the laser beam bypasses all of the one or several prohibited regions.
  • Safety is enhanced when the control system is configured such that all of the prohibited regions must be bypassed.
  • the control system may block the laser beam from being outputted unless the trajectory is identified which causes the laser beam to bypass all of the prohibited regions.
  • the control system is configured to use the evaluated image data to determine at least the first trajectory for the laser beam to the target which is spaced from each of the one or several prohibited regions by at least a threshold distance.
  • the control system is configured to use the evaluated image data to determine second trajectories for the laser beam to the target which pass through at least one of the one or several prohibited regions.
  • the control system is configured to use the evaluated image data to determine third trajectories for the laser beam to the target which bypass each of the one or several prohibited regions and which are spaced by less than the threshold distance from at least one of the one or several prohibited regions.
  • different candidate trajectories for the laser beam may be ranked depending on whether they pass through at least one prohibited region (in which case they are automatically determined to be unsuitable), bypass all prohibited regions with a spacing greater than the safety margin distance (in which case the trajectory is suitable), or bypass all prohibited regions while coming within the safety margin distance of at least one of the prohibited regions (in which case the trajectory may be flagged as requiring further consideration).
  • the first trajectory and, if present, the second and third trajectories may be determined automatically by the control system.
  • the results may be output to a surgeon for verification, approval, and, if desired, modification.
  • the control system can automatically evaluate a number of different trajectories with regard to their arrangement relative to, e.g., the prohibited region(s).
  • the first trajectory and, if present, the second and third trajectories may be determined by the control system in response to and as a function of user input.
  • the user input may specify different possible entry points for trajectories on a surface of the hard tissue.
  • control system provides assistance to the surgeon.
  • the control system uses the user input to determine which trajectory or trajectories are to be evaluated with respect to their arrangement relative to the target and the prohibited regions. The results are visualized on the user interface.
  • the user interface is configured to output the at least one first trajectory, the second trajectories, and the third trajectories in a visually distinguishable manner.
  • the surgical system assists a user in the potentially complex task of determining which trajectory is suitable for performing laser ablation on the mastoid portion.
  • the medical image data comprises a computer tomography (CT) image and/or a magnetic resonance imaging (MRI) image and/or image data acquired with another medical imaging technique.
  • CT computer tomography
  • MRI magnetic resonance imaging
  • the surgical system is enabled to determine geometrical features of the mastoid portion, cochlea, and/or nerve tissue for guiding surgery planning and/or for automatically preventing the laser ablation from being performed too close to critical nerve tissue (such as the facial nerve).
  • the surgical system may be an automatic surgical system or a surgery assist device.
  • the surgical system may further comprise an imaging modality configured to capture the medical image data and provide the medical image data to the control system.
  • the surgical system may further comprise components for determining a relative position of the laser beam generator relative to the subject’s skull, such as a 3D positioning system.
  • a 3D positioning system e.g., by means of retroreflectors, light sources, and at least two cameras.
  • the robot arm may have at least five degrees of freedom. This allows both the location of a laser beam output orifice (three degrees of freedom) and an orientation of the laser beam axis (two degrees of freedom) to be automatically adjusted under the control of the control system.
  • a method of controlling the robot arm and the laser beam generator of the surgical system of any one of the aspects or embodiments is performed by the control system of the surgical system and comprises receiving, by the control system, image data that represents a volume containing at least part of a temporal bone of a subject; evaluating, by the control system, the medical image data; and using, by the control system, the evaluated image data to generate and output control signals or control data such that, upon activation of the laser beam generator, the laser beam impinges on the mastoid portion.
  • the control method can provide the control signals required to control the robot arm and laser beam generator to remove hard tissue in a mastoid portion by way of laser ablation.
  • the position and operation of the laser beam generator is controlled by the control system, using results of an image evaluation. High accuracy and precision in hard tissue ablation is attained thereby.
  • the surgical system does not exert mechanical stress on hard tissue of the mastoid portion that is not ablated, allowing the adverse effects of electromechanical tools to be avoided.
  • the control method is also less prone to causing damage to soft tissue, in contrast to mechanical systems that are prone to mechanically damaging soft tissue in proximity to a trajectory along which hard tissue ablation is performed.
  • the control method is suitable for specific procedures such as an antrostomy, a mastoidectomy, and/or a tympanotomy.
  • the invention is a method of removing hard tissue of a mastoid portion of a subject, the method comprising: receiving, by a control system, image data that represents a volume containing at least part of a skull or temporal bone of a subject; evaluating, by the control system, the medical image data; using, by the control system, the evaluated image data to control a laser beam generator to cause the laser beam generator to emit a laser beam that impinges on e.g. a mastoid portion of the temporal bone.
  • the surgical method is configured in such a manner that it can remove hard tissue in a mastoid portion by way of laser ablation.
  • the position and operation of the laser beam generator are controlled by the control system, using results of an image evaluation. High accuracy and precision in hard tissue ablation is attained thereby.
  • the surgical method does not exert mechanical stress on hard tissue of the mastoid portion that is not ablated, allowing the adverse effects of electromechanical tools to be avoided.
  • the control method is also less prone to causing damage to soft tissue, in contrast to mechanical systems that are prone to mechanically damaging soft tissue in proximity to a trajectory along which hard tissue ablation is performed.
  • the surgical method is configured for use in specific procedures such as an antrostomy, a mastoidectomy, and/or a tympanotomy.
  • the method may further comprise using, by the control system, the evaluated image data to control a robot arm on which the laser beam generator is arranged.
  • a desired position and orientation of the laser beam generator can be controlled in an accurate and precise manner, using the evaluated image data.
  • the method comprises causing the laser beam generator to ablate the hard tissue of the mastoid portion to perform one, several, or all of: an antrostomy; a mastoidectomy; templating for a mastoidectomy; a tympanotomy; forming extended 3D, 2D, or 1 D incisions along sensitive structures.
  • the ablation is preferably performed within, and limited to, a volume within the hard tissue which is spaced from all delicate tissue (such as nerve or vascular tissue or other delicate tissue) by at least a safety margin distance.
  • volumetric tissue removal and/or the formation of one or several cuts is attained using laser ablation for performing specific interventions.
  • Antrostomy, mastoidectomy, and/or tympanotomy are particularly suitable for being performed using a laser beam generator positioned by a robot arm and controlled using the evaluated image data.
  • critical regions such as a facial nerve
  • laser beam generator operation allowing the surgical system to ensure that such regions remain unaffected by the laser beam ablation.
  • the hard tissue ablated by the laser beam is a conical or frustoconical volume of the hard tissue.
  • Laser ablation makes it possible to efficiently and accurately form conical or frustoconical passages in the mastoid portion, which are particularly suitable for, e.g., inserting an electrode of a hearing assistance system (such as a cochlea implant system) or another elongate object through the mastoid portion.
  • a hearing assistance system such as a cochlea implant system
  • the method comprises determining a geometry of at least part of a cochlea of the subject and using the determined geometry to control a beam axis of the laser beam.
  • the control system controls the beam axis relative to a tangent to the cochlea.
  • the method comprises segmenting the medical image data to detect one or several surfaces of the mastoid portion and using the detected one or several surfaces to control the laser beam generator.
  • the one or several surfaces comprise a surface at a tympanic antrum and/or a sulcus tympanicus.
  • the laser beam may be controlled in such a manner that it does not perform laser ablation beyond the mastoid surface at the tympanic antrum and/or the sulcus tympanicus. Safety is enhanced by using the image segmentation.
  • the method comprises using the detected one or several surfaces to control the laser beam generator to ensure a spacing between the laser beam and each of the one or several surfaces.
  • the spacing is adjustable by an input enabled by a user interface.
  • a safety distance margin may be maintained that prevents the laser beam from impinging on tissue where it could have adverse effects, such as a facial nerve. Safety is enhanced by means of this technique.
  • the spacing may be equal to the safety margin distance which will be discussed in more detail below.
  • the method comprises using the segmented medical image data to discriminate an interior surface defining a mastoid cell from a surface of the mastoid portion that does not delimit a mastoid cell.
  • the method comprises operating a safety mechanism that switches off or blanks the laser beam, and further comprises selectively overriding, by the control system, the safety mechanism in response to confirming that the laser beam reaches the interior surface while being spaced from the surface of the mastoid portion that does not delimit a mastoid cell.
  • Safety is further enhanced by providing the safety mechanism that switches off or blanks the laser beam by default when a surface of hard tissue is reached and that is selectively overridden in response to confirming that the surface is an internal surface within the mastoid portion, which delimits a mastoid cell.
  • the method preferably comprises controlling a user interface to enable receiving input specifying one or several prohibited regions relative to a graphical representation of the medical image data, wherein the method comprises using the evaluated image data to prevent the laser beam from impinging onto the one or several prohibited regions.
  • Safety is further enhanced by providing a user interface that allows prohibited regions to be defined, while implementing an automatic mechanism of avoiding such prohibited regions.
  • the control system may be operative such that the prohibited regions include nerve tissue, in particular a facial nerve.
  • the method comprises using the evaluated image data to prevent the laser beam from passing through a volume located within a safety margin distance around any of the one or several prohibited regions.
  • Safety is further enhanced by ensuring that a safety margin distance around any of the prohibited regions is ensured, to prevent the laser beam from passing closer than the safety margin distance along any of the prohibited regions.
  • the surgical system may allow the safety margin distance to be adjusted, thereby providing enhanced controllability.
  • the method comprises receiving, by the user interface, additional input specifying a target and using the evaluated image data to identify a trajectory for the laser beam to the target such that the laser beam bypasses all of the one or several prohibited regions.
  • Safety is enhanced when the control system is configured such that all of the prohibited regions must be bypassed.
  • the control system may block the laser beam from being outputted unless the trajectory is identified which causes the laser beam to bypass all of the prohibited regions.
  • the method comprises using the evaluated image data to determine at least the first trajectory for the laser beam to the target which is spaced from each of the one or several prohibited regions by at least a threshold distance, second trajectories for the laser beam to the target which pass through at least one of the one or several prohibited regions, and third trajectories for the laser beam to the target which bypass each of the one or several prohibited regions and which are spaced by less than the threshold distance from at least one of the one or several prohibited regions.
  • different candidate trajectories for the laser beam may be ranked depending on whether they pass through at least one prohibited region (in which case they are automatically determined to be unsuitable), bypass all prohibited regions with a spacing greater than the safety margin distance (in which case the trajectory is suitable), or bypass all prohibited regions while coming within the safety margin distance of at least one of the prohibited regions (in which case the trajectory may be flagged as requiring further consideration).
  • the user interface outputs the at least one first trajectory, the second trajectories, and the third trajectories in a visually distinguishable manner.
  • the surgical system assists a user in the potentially complex task of determining which trajectory is suitable for performing laser ablation on the mastoid portion.
  • the medical image data comprises a computer tomography (CT) image and/or a magnetic resonance imaging (MRI) image and/or image data acquired with another medical imaging technique.
  • CT computer tomography
  • MRI magnetic resonance imaging
  • the surgical system is enabled to determine geometrical features of the mastoid portion, cochlea, and/or nerve tissue for guiding surgery planning and/or for automatically preventing the laser ablation from being performed too close to critical nerve tissue (such as the facial nerve).
  • the method may be performed by or using an automatic surgical system or a surgery assist device.
  • the method may further comprise acquiring, using a medical imaging system, the medical image data and provide the medical image data to the control system.
  • the medical imaging system may be or may comprise a CT and/or MRI system and/or similar imaging systems.
  • the method may further comprise determining a relative position of the laser beam generator relative to the subject’s skull, using, e.g., a 3D positioning system.
  • a 3D positioning system e.g., by means of retroreflectors, light sources, and at least two cameras.
  • the invention is a surgery planning system which comprises a first interface configured to receive medical image data of a subject, wherein the medical image data represents a volume containing at least part of a temporal bone of the subject; a processing system configured to evaluate the medical image data to determine a laser ablation trajectory for laser ablation of hard tissue of a mastoid portion of the temporal bone and use the determined laser ablation trajectory to generate output; and a second interface configured to output the generated output.
  • the surgery planning system is configured in such a manner that it can determine a trajectory for laser ablation of hard tissue in a mastoid portion. High accuracy and precision in hard tissue ablation is attained thereby.
  • the surgery planning system is configured for use with a tissue ablation technique that does not exert mechanical stress neither on hard tissue of the mastoid portion that is not ablated, allowing the adverse effects of electromechanical tools to be avoided.
  • the surgery planning system is configured for use with a tissue ablation technique that is also less prone to damaging soft tissue, in contrast to mechanical systems that are prone to mechanically damaging soft tissue in proximity to a trajectory along which hard tissue ablation is performed.
  • the surgery planning system is configured for use in association with specific procedures such as an antrostomy, a mastoidectomy, and/or a tympanotomy.
  • the hard tissue may be tissue which is mineralized and/or has a firm intercellular matrix.
  • the hard tissues may be bone tissue and/or cartilage tissue or similar.
  • the processing system is configured to determine the trajectory to perform one, several, or all of: an antrostomy; a mastoidectomy; templating for a mastoidectomy; a tympanotomy; forming extended 3D, 2D, or 1 D incisions along sensitive structures.
  • the laser ablation trajectory is preferably determined such that it is located within, and limited to, a volume within the hard tissue which is spaced from all delicate tissue (such as nerve or vascular tissue or other delicate tissue) by at least a safety margin distance.
  • volumetric tissue removal and/or the formation of one or several cuts can be planned for performing specific interventions.
  • Antrostomy, mastoidectomy, and/or tympanotomy are particularly suitable for being performed using laser beam ablation along a trajectory determined using the evaluated image data.
  • critical regions such as a facial nerve
  • the surgery planning system is configured to perform surgery planning for removal of tissue that comprises hard tissue without being limited to hard tissue.
  • the system is capable of removing combinations of hard tissue and, e.g., cancerous tissue.
  • the surgery planning system is configured to determine the trajectory such that a volume ablated by the laser beam is or comprises a conical or frustoconical volume of the hard tissue.
  • Laser ablation makes it possible to efficiently and accurately form conical or frustoconical passages in the mastoid portion, which are particularly suitable for, e.g., inserting an electrode of a hearing assistance system (such as a cochlea implant system) or another elongate object such as an endoscope through the mastoid portion.
  • a hearing assistance system such as a cochlea implant system
  • another elongate object such as an endoscope
  • the processing system is configured to determine a geometry of at least part of a cochlea of the subject and to use the determined geometry to control a beam axis of the laser beam.
  • the processing system is configured to determine the trajectory relative to a tangent to the cochlea.
  • the processing system is configured to segment the medical image data to detect one or several surfaces of the mastoid portion and to use the detected one or several surfaces to control the laser beam generator.
  • the one or several surfaces comprise a surface at a tympanic antrum and/or a sulcus tympanicus.
  • the laser beam trajectory may be determined in such a manner no laser ablation is performed beyond the mastoid surface at the tympanic antrum and/or the sulcus tympanicus. Safety is enhanced by using the image segmentation.
  • the processing system is configured to use the detected one or several surfaces to determine the laser beam trajectory to ensure a spacing between the laser beam and each of the one or several surfaces.
  • the spacing is adjustable by an input enabled by a user interface.
  • a safety distance margin may be maintained that prevents the laser beam from impinging on tissue where it could have adverse effects, such as a facial nerve. Safety is enhanced by means of this technique.
  • the spacing may be equal to the safety margin distance which will be discussed in more detail below.
  • the processing system is configured to use the segmented image data to discriminate an interior surface defining a mastoid cell from a surface of the mastoid portion that does not delimit a mastoid cell.
  • the surgery planning system preferably comprises a user interface configured to receive input specifying one or several prohibited regions relative to a graphical representation of the medical image data, wherein the processing system is configured to use the evaluated image data to prevent the laser beam trajectory from impinging onto the one or several prohibited regions.
  • Safety is further enhanced by providing a user interface that allows prohibited regions to be defined, while implementing an automatic mechanism of avoiding such prohibited regions.
  • the processing system may be operative such that the prohibited regions include nerve tissue, in particular a facial nerve.
  • the one or several prohibited regions are regions which contain delicate tissue, in particular soft tissue.
  • the one or several prohibited regions may be regions in which soft tissue of the nerval or vascular system are disposed.
  • the processing system is configured to use the evaluated image data to prevent the laser beam trajectory from passing through a volume located within a safety margin distance around any of the one or several prohibited regions.
  • Safety is further enhanced by ensuring that a safety margin distance around any of the prohibited regions is ensured, to prevent the laser beam from passing closer than the safety margin distance along any of the prohibited regions.
  • the surgery planning system may allow the safety margin distance to be adjusted, thereby providing enhanced controllability.
  • the user interface is configured to receive additional input specifying a target (which may be a target point) and the processing system is configured to use the evaluated image data to identify the laser beam trajectory to the target such that the laser beam trajectory bypasses all of the one or several prohibited regions.
  • Safety is enhanced when the processing system is configured such that all of the prohibited regions must be bypassed.
  • the processing system may block the laser beam from being outputted unless the trajectory is identified which causes the laser beam to bypass all of the prohibited regions.
  • the processing system is configured to use the evaluated image data to determine at least the first trajectory for the laser beam to the target which is spaced from each of the one or several prohibited regions by at least a threshold distance.
  • the processing system is configured to use the evaluated image data to determine second trajectories for the laser beam to the target which pass through at least one of the one or several prohibited regions.
  • the processing system is configured to use the evaluated image data to determine third trajectories for the laser beam to the target which bypass each of the one or several prohibited regions and which are spaced by less than the threshold distance from at least one of the one or several prohibited regions.
  • different candidate trajectories for the laser beam may be ranked depending on whether they pass through at least one prohibited region (in which case they are automatically determined to be unsuitable), bypass all prohibited regions with a spacing greater than the safety margin distance (in which case the trajectory is suitable), or bypass all prohibited regions while coming within the safety margin distance of at least one of the prohibited regions (in which case the trajectory may be flagged as requiring further consideration).
  • the first trajectory and, if present, the second and third trajectories may be determined automatically by the processing system.
  • the results may be output to a surgeon for verification, approval, and, if desired, modification.
  • the processing system can automatically evaluate a number of different trajectories with regard to their arrangement relative to, e.g., the prohibited region(s).
  • the first trajectory and, if present, the second and third trajectories may be determined by the processing system in response to and as a function of user input.
  • the user input may specify different possible entry points for trajectories on a surface of the hard tissue.
  • the processing system provides assistance to the surgeon.
  • the processing system uses the user input to determine which trajectory or trajectories are to be evaluated with respect to their arrangement relative to the target and the prohibited regions.
  • the results are visualized on the user interface.
  • the user interface is configured to output the at least one first trajectory, the second trajectories, and the third trajectories in a visually distinguishable manner.
  • the surgery planning system assists a user in the potentially complex task of determining which trajectory is suitable for performing laser ablation on the mastoid portion.
  • the medical image data comprises a computer tomography (CT) image and/or a magnetic resonance imaging (MRI) image and/or image data acquired with another medical imaging technique.
  • CT computer tomography
  • MRI magnetic resonance imaging
  • the surgery planning system is enabled to determine geometrical features of the mastoid portion, cochlea, and/or nerve tissue for guiding surgery planning and/or for automatically preventing the laser ablation from being performed too close to critical nerve tissue (such as the facial nerve).
  • the invention is a surgery planning method which comprises receiving medical image data of a subject, wherein the medical image data represents a volume containing at least part of a temporal bone of the subject; evaluating, by a surgery planning system, the medical image data to determine a laser ablation trajectory for laser ablation of hard tissue of a mastoid portion of the temporal bone and using the determined laser ablation trajectory to generate output; and outputting the generated output.
  • the surgery planning method may be performed automatically by the surgery planning system or the surgery system according to any aspect or embodiment of the invention.
  • machine- readable instruction code which, when executed by one or several programmable circuits (e.g., of the control system or the processing system), cause execution of the method according to any one aspect or embodiment.
  • non-transitory storage medium storing machine-readable instruction code which, when executed by one or several programmable circuits (e.g., of the control system or the processing system), cause execution of the method according to any one aspect or embodiment.
  • Fig. 1 shows a surgical system according to an embodiment of the invention
  • Fig. 2 shows a block diagram of a control system of the surgical system of Fig. 1 ;
  • Fig. 3 shows a flow chart of a method according to an embodiment of the invention
  • Fig. 4 shows a view illustrating one mode of operation of the surgical system of Fig. 1 ;
  • Fig. 5 shows a view illustrating another mode of operation of the surgical system of Fig. 1 ;
  • Fig. 6 shows a view illustrating yet another mode of operation of the surgical system of Fig. 1 ;
  • Fig. 7 shows a view illustrating yet another mode of operation of the surgical system of Fig. 1 ;
  • Fig. 8 shows a flow chart of a method according to an embodiment of the invention.
  • Fig. 9 shows a user interface of the surgical system of Fig. 1 ;
  • Fig. 10 shows a flow chart of a method according to an embodiment of the invention
  • Fig. 11 shows a block diagram of a laser control component of the control system of the surgical system of Fig. 1 .
  • Fig. 12 shows a trajectory determined using a surgery system or method according to another embodiment of the invention.
  • Fig. 13 shows trajectories determined using a surgery system or method according to another embodiment of the invention.
  • the techniques disclosed herein may be used for planning a surgery that can be performed using a laser beam generator.
  • the term “laser beam generator” encompasses at least one component that outputs a laser beam.
  • the laser beam generator may be formed by an assembly of optical components that outputs the laser beam.
  • the laser beam generator may but does not need to comprise a laser.
  • the optical components from which the laser beam generator is formed may be or may comprise an end of an optical fiber or other lightguide or lenses, shutters, or other optical components. These optical components may be mounted on a robot arm so as to be moveable. These optical components may be separate from the laser.
  • the laser itself may be stationary and need not be displaceable jointly with the optical components that act as laser beam generator.
  • Fig. 1 shows a surgical system 1 according to an embodiment of the invention.
  • the surgical system 1 comprises a robot arm 11 .
  • the surgical system 1 comprises a surgical tool comprising a laser beam generator 12.
  • the laser beam generator 12 is arranged on the robot arm 11.
  • the laser beam generator 12 configured to emit a laser beam 10 directed onto a mastoid portion to perform tissue ablation of hard tissue of e.g. the mastoid portion.
  • the surgical system 11 comprises a control system 20 configured to control the robot arm 11 and the laser beam generator 12.
  • the control system 20 is configured to evaluate image data received from a source of image data 18 and use the evaluated image data to control the robot arm 11 and the laser beam generator 12 such that laser ablation is performed for hard tissue (e.g., bone tissue) of a mastoid portion of a subject’s skull 19.
  • hard tissue e.g., bone tissue
  • the laser beam generator 12 of the surgical system according to the invention may have a configuration and operation as disclosed in EP 3897438 A1 and/or EP 4 013 329 A1 .
  • Processing of the medical image data performed by the control system 20 may comprise a segmentation to identify surfaces of e.g. the mastoid portion of the subject’s skull 19.
  • the control system 20 uses the processed image data (e.g., the segmented image data) to control the position, orientation, and output of the laser beam generator 12.
  • the subject may be supported on a support 13 during the laser ablation disclosed herein.
  • the control system 20 may use the processed image data in various ways.
  • the control system 20 may use the processed medical image data to determine whether laser ablation of hard tissue of the mastoid portion is to be continued.
  • the mastoid portion includes cavities, referred to as mastoid cells in the art.
  • the cavities are often filled with a fluid (e.g., air), acting as pneumatic cells.
  • the control system 20 may use the processed image data to discriminate internal surfaces of the mastoid portion, which delimit mastoid cell(s), from one or several outer surfaces of the mastoid portion that delimit a body lumen different from the mastoid cells (e.g., a tympanic cavity or other lumen of the middle or inner ear).
  • the control system 20 uses the processed medical image data to enable user input specifying constraints or other conditions for laser ablation of hard tissue of the mastoid portion.
  • the control system 20 may comprise a user interface (III) or may be coupled to a III separate from the control system 20 to output a graphical representation of the medical image data.
  • the III is configured to enable user input specifying one, several or all of: a target relative to a graphical representation of the medical image data, prohibited regions through which laser light must not pass, a safety margin by which laser light is to bypass any of the prohibited regions.
  • the III may be configured to enable user input specifying various candidate entry points for the laser beam and provide the user with information as to whether and to what degree the respective candidate entry points for the laser beam are suitable when considering the target, the prohibited regions, and the safety margin distance.
  • the control system 20 may use the processed medical image data to provide assistance in the definition of, e.g., the prohibited regions.
  • the control system 20 may determine boundaries of a hard tissue lumen that contains nerve tissue (such as a facial nerve) and on which the laser beam must not impinge.
  • the control system 20 may control the III to enable a user input specifying a volume through which the laser beam is not allowed to pass and may automatically enlarge that volume to extend to boundaries of hard tissues.
  • the control system 20 may automatically extend the prohibited region to a three-dimensional volume delimited by hard tissue boundaries, which in turn may be determined automatically by the processed image data (e.g., as results of image processing).
  • the surgical system may thereby provide a function that can be thought of a “lasso” function that captures all of a 3D volume prohibited for the laser beam, in response to an input at the III that specifies part of the 3D volume as containing tissue that must not be irradiated with the laser beam (such as the nervus facialis).
  • the source of image data 18 may comprise a data storage system that has stored therein medical image data.
  • the medical image data may comprise a computer tomography (CT) and/or magnetic resonance imaging (MRI) image and/or imaging technology with similar purpose.
  • CT computer tomography
  • MRI magnetic resonance imaging
  • the source of image data 18 may comprise an image acquisition device that captures CT and/or MRI image data.
  • the source of image data 18 may be or may comprise a CT system and/or an MRI system and/or similar imaging technology.
  • the control system 20 is configured in such a way that it controls the robot arm 11 and the laser beam generator 12 to perform laser ablation of hard tissue of e.g. the mastoid portion.
  • the laser beam generator 12 may be formed by optical components (such as an end of an optical fiber or other lightguide, an output optics, or similar) which may be separate from the laser.
  • the laser itself need to be positioned on the robot arm.
  • the control system 20 may be configured to perform any one or any combination of laser ablation procedures, which may include any one, several, or all of an antrostomy, a mastoidectomy, mastoidectomy templating, a tympanotomy; forming extended 3D, 2D, or 1 D incisions along sensitive structures.
  • Mastoidectomy templating or templating for a mastoidectomy means the laser ablation along one or several surfaces that delimit a 3D volume of hard tissue that can be subsequently removed by an electromechanical tool.
  • the surfaces of the hard tissue remaining after the mastoidectomy is hard tissue that has been exposed to laser ablation but which has not been exposed to the mechanical stresses, exerted by an electromechanical tool.
  • the surgical system is also less prone to damaging soft tissue, in contrast to mechanical systems that are prone to mechanically damaging soft tissue in proximity to a trajectory along which hard tissue ablation is performed.
  • the control system 20 may be configured to use the output of a navigation system to control the robot arm 11 and/or laser beam generator 12.
  • the navigation system may include optical elements including light sources 17, reflectors 16, and cameras 14’, which may be arranged on the laser beam generator 12, a reference 15 mounted on the subject’s head 19, and a navigation system component 14. It will be appreciated that light source(s), reflector(s), and camera(s) may be distributed in various ways among the laser beam generator 12, reference 15, and navigation system component 14 to allow determination of the relative position and orientation of the laser beam generator 12 and subject’s head 19. Such navigation systems are available to the skilled person and their operation is understood by the skilled person.
  • the relative position and orientation as provided by the navigation system may be used by the control system 20 to determine which further adjustments need to be made to ensure that the laser beam 10 impinges on the mastoid portion in a desired manner.
  • Fig. 2 shows a block diagram of the control system 20.
  • the control system 20 is configured to perform the various processing and control functions disclosed herein.
  • the control system 20 may execute machine-readable instruction code stored in a storage system 23 to perform the various processing and control functions disclosed herein.
  • the control system 20 may be implemented as a computer or server communicatively coupled, via wired or wireless connections, to the robot arm 11 and laser beam generator 12.
  • the control system 20 comprises one or several interface(s) 21.
  • the one or several interface(s) 21 may comprise a digital interface configured to receive the medical image data 41 .
  • the one or several interface(s) 21 may comprise a digital and/or analog interface to output control data or signals 42 for controlling the robot arm 11 and control data or signals 43 for controlling the laser beam generator 12.
  • the interface(s) 21 may also receive navigation system data or signals from the navigation system which indicates a relative position and a relative orientation of the laser beam generator relative to the skull or mastoid portion.
  • the navigation system data or signals may be used for generating the control data or signals 42, 43 to attain a desired real-world position of the laser beam generator 12 relative to the mastoid portion.
  • the control system 20 comprises a III 22.
  • the III may be provided as a device separate from the control system 20 and controlled by the control system 22.
  • a processing system 30 of the control system 20 controls the III 22 to enable user input that is relevant to the control of the robot arm 11 and laser beam generator 12.
  • the III 22 may be an input-output interface.
  • the control system 20 may control the III 22 to output a graphical representation of the medical image data and enable user input in relation to the output graphical representation of the medical image data.
  • the graphical representation may include a graphical representation of the mastoid portion.
  • the III 22 may enable a user input that specifies a target relative to a graphical representation of the medical image data.
  • the III 22 may enable a user input that specifies prohibited regions through which laser light must not pass, in relation to the graphical representation.
  • the processing system 30 may comprise one or several integrated circuit(s) (IC(s)).
  • the one or several IC(s) may comprise one or several application specific integrated circuit(s) (ASIC(s)), controller(s), processor(s), field programmable gate array(s) (FPGA(s)), quantum gates, or combinations thereof.
  • the processing system 30 may execute machine-readable instruction code to perform any of the functions disclosed herein.
  • the processing system 30 is configured to perform an image processing 32 to process the medical image data 41 .
  • the image evaluation 32 may comprise an image segmentation 31.
  • the image segmentation 31 may determine a 3D outer contour of the mastoid portion.
  • the processing system 30 may use the 3D outer contour for various purposes, such as ensuring that no tissue ablation is performed outside of the 3D outer contour of the mastoid portion when performing an antrostomy, a mastoidectomy, mastoidectomy templating, and/or a tympanotomy.
  • the processing system 30 may use the 3D outer contour for determining whether a surface encountered by the laser beam 10 and detected by the laser beam generator 12 is an inner surface of the mastoid portion that delimits a mastoid cell (in which case laser beam ablation can be continued) or is at the 3D outer contour (in which case laser beam ablation is typically stopped).
  • the image evaluation 32 may perform functions in addition to image segmentation. For illustration, geometrical characteristics of the mastoid portion may be determined (such as a cloud of points on the surface; dimensions of various parts of the mastoid portion; etc.) and used for assessing the viability of various laser trajectories through the mastoid portion.
  • the processing system 30 is configured to perform a laser beam control 33.
  • the laser beam control 33 is configured to generate control signals or data for outputting to the laser beam generator 12, to cause the laser beam 10 to impinge on the mastoid portion.
  • the laser beam control 33 is configured to generate the control signals or data for outputting to the laser beam generator 12 so as to ensure that the laser beam 10 is directed along an allowed laser beam trajectory that bypasses all prohibited regions by more than a safety margin distance.
  • the laser beam control 33 is configured to generate the control signals or data for outputting to the laser beam generator 12 so as to perform laser ablation of hard tissue of e.g. the mastoid portion for one or several of an antrostomy, a mastoidectomy, mastoidectomy templating, a tympanotomy.
  • the processing system 30 is configured to perform a robot arm control 34.
  • the robot arm control 34 is configured to generate control signals or data for outputting to the robot arm 11 , to ensure that the laser beam generator 12 is positioned at a position and orientation relative to the skull, and in particular relative to the mastoid portion, which allows the laser beam 10 to impinge on the mastoid portion.
  • the robot arm control 34 is configured to generate the control signals or data for outputting to the laser beam generator 12 so as to ensure that the laser beam 10 is directed along an allowed laser beam trajectory that bypasses all prohibited regions by more than a safety margin distance.
  • the robot arm control 34 is configured to generate the control signals or data for outputting to the robot arm 11 so as to perform laser ablation of hard tissue of the mastoid portion for one or several of an antrostomy, a mastoidectomy, mastoidectomy templating, a tympanotomy.
  • Fig. 3 is a flow chart of a method 50.
  • the method 50 may be performed automatically by the surgical system 1 , e.g., by the control system 20 of the surgical system 1 .
  • the control system 20 evaluates medical image data.
  • the medical image data may comprise CT and/or MRI image data and/or medical image data acquired with medical imaging technologies with similar purpose.
  • the evaluation may comprise an image segmentation.
  • the image segmentation may comprise determining a 3D outer contour of the mastoid portion.
  • the control system 20 enables receipt of user input.
  • the user input may specify a target and prohibited regions.
  • the control system 20 may enable this user input to be received relative to a graphical representation of the medical image data that includes a graphical representation of the mastoid portion.
  • the control system 20 controls the laser beam generator 12 and the robot arm 11 to cause laser ablation of hard tissue of e.g. the mastoid portion.
  • the laser ablation may be or may comprise an antrostomy, a mastoidectomy, mastoidectomy templating, and/or a tympanotomy.
  • Fig. 4 illustrates operation of the surgical system 20 for an antrostomy.
  • the control system 20 determines an outer 3D contour of e.g. the mastoid portion 60 by processing the medical image data.
  • the control system 20 may determine at least surfaces 61 , 62 that delimit a lumen of or around the middle ear and/or inner ear.
  • the control system 20 causes the laser beam 10 to perform laser ablation of a contiguous 3D volume of hard tissue 64 to perform an antrostomy.
  • the control system 20 is configured to distinguish surfaces of mastoid cells 63 that contain air from the surfaces 61 , 62 that delimit a lumen in which delicate tissue (such as a cochlea or nerves) is present.
  • Laser ablation is continued when the laser beam 10 impinges on a surface of a mastoid cell 63. Laser ablation is controlled such that the laser ablation stops at a distance from any surface 61 , 62 beyond which no laser ablation must be performed.
  • Fig. 5 illustrates operation of the surgical system 20 for mastoidectomy templating.
  • the control system 20 determines an outer 3D contour of the mastoid portion 60 by processing the medical image data.
  • the control system 20 may determine at least surfaces 61 , 62 that delimit a lumen of or around the middle ear and/or inner ear.
  • the control system 20 causes the laser beam 10 to perform laser ablation so as to form gaps within the hard tissue along one or several surfaces 65 that enclose hard tissue that is to be removed for performing a mastoidectomy. Removal of the hard tissue enclosed by the templating gaps 65 may be performed by laser ablation or by an electromechanical tool.
  • the control system 20 is configured to distinguish surfaces of mastoid cells 63 that contain air from the surfaces 61 , 62 that delimit a lumen in which delicate tissue (such as a cochlea or nerves) is present.
  • Laser ablation is continued for forming the templating gaps 65 when the laser beam 10 impinges on a surface of a mastoid cell 63.
  • Laser ablation is controlled such that the laser ablation stops at a distance from any surface 61 , 62 beyond which no laser ablation must be performed.
  • Fig. 6 illustrates operation of the surgical system 20 for a tympanotomy.
  • the control system 20 determines an outer 3D contour of the mastoid portion 60 by processing the medical image data.
  • the control system 20 may determine at least surfaces 61 , 62 that delimit a lumen of or around the middle ear and/or inner ear.
  • the control system 20 causes the laser beam 10 to perform laser ablation of a contiguous 3D volume of hard tissue 66 to perform e.g. the tympanotomy.
  • the volume of hard tissue 66 may be conical or frustoconical.
  • the control system 20 is configured to distinguish surfaces of mastoid cells 63 that contain air from the surfaces 61 , 62 that delimit a lumen in which delicate tissue (such as a cochlea or nerves) is present.
  • Laser ablation is continued when the laser beam 10 impinges on a surface of a mastoid cell 63 during laser ablation of the volume of hard tissue 66.
  • Laser ablation is controlled such that the laser ablation does not exceed any surface 61 , 62 beyond which no laser ablation must be performed when performing laser ablation of the volume of hard tissue 66.
  • the control system 20 may be configured such that information other than a geometry of e.g. the mastoid portion is determined by processing the medical image data.
  • the control system 20 may be configured to process the medical image data to determine a geometry of anatomical structures of or around the middle ear or inner ear, such as a cochlea or other anatomical structures.
  • the control system 20 may use the processed medical image data (e.g., the segmented image data) to determine a position of at least part of the cochlea and an extension direction of at least part of the cochlea.
  • the control system 20 may use the processed medical image data (e.g., the segmented image data) to determine a position and extension direction of a part of the cochlea into which an object is to be inserted through the mastoid portion.
  • the control system 20 may be configured to use the geometry of the mastoid portion and of the cochlea determined by processing the medical image data to determine a laser beam trajectory for performing a tympanotomy, which allows an object to exit the mastoid portion at a desired target for being guided towards the cochlea for insertion into the cochlea.
  • a cochlea electrode of a hearing assistance device e.g., of a hearing aid
  • a hearing assistance device e.g., of a hearing aid
  • Fig. 7 illustrates operation of the surgical system 20 in which the laser beam generator 12 and robot arm 11 are controlled using both a geometry of the mastoid portion and geometry of the cochlea determined by image data processing.
  • the control system 20 is configured to determine an outer 3D contour of the mastoid portion 60 by processing the medical image data.
  • the control system 20 is configured to determine a geometry of the cochlea 70 (in particular a position and orientation relative to the mastoid portion 60) by processing the medical image data.
  • the control system 20 is configured to control the robot arm 11 and laser beam generator 12 to perform laser ablation of a volume of hard tissue 66 of the mastoid portion 60.
  • the laser ablation may be performed such that the volume of hard tissue 66 extends to a target 67 at a surface of the mastoid portion 60 and has an orientation which depends on the geometry of the cochlea (e.g., on a tangent 72 to the cochlea 70).
  • the volume of hard tissue 66 may be automatically determined such that the laser beam maintains a safety margin distance from any prohibited region, ablates the volume of hard tissue 66 to the target 67, and has a direction which allows an object 71 (such as a cochlear electrode) to be inserted into the cochlea 70.
  • Fig. 8 is a flow chart of a method 80.
  • the method 80 may be performed automatically by the surgical system 1 , e.g., by the control system 20 of the surgical system 1 .
  • the control system 20 evaluates medical image data.
  • the medical image data may comprise CT and/or MRI image data and/or imaging technology with similar purpose.
  • the evaluation may comprise an image segmentation.
  • the image segmentation may comprise determining a 3D outer contour of the mastoid portion.
  • the control system 20 evaluates medical image data.
  • the medical image data may comprise MRI image data, CT image data or other medical image data.
  • the evaluation may comprise an image segmentation.
  • the image segmentation may comprise determining a position and geometry of the cochlea.
  • the control system 20 controls the laser beam generator 12 and the robot arm 11 to cause laser ablation of hard tissue of the mastoid portion.
  • the laser ablation may be or may comprise a tympanotomy in which hard tissue of the mastoid portion is ablated by the laser beam 10.
  • the control system 20 may control the laser beam generator 12 and the robot arm 11 such that the ablated volume of hard tissue 66 allows passage of an object (e.g., of a cochlear electrode) to the cochlea while having an orientation that depends on the geometry of the cochlea and its position relative to the mastoid portion.
  • an object e.g., of a cochlear electrode
  • the surgical system 1 may comprise the III 22 which may operate as an inputoutput interface.
  • the III 22 may be controlled to enable inputting of information by a user.
  • the control system 20 may use the information to automatically determine suitable laser beam trajectories, also using the results of the medical image processing.
  • Fig. 9 is a schematic representation of graphics 90 output via the III 22.
  • the control system 20 is configured to control the III 22 to output a graphical representation 100 of an anatomical structure (such as the mastoid portion).
  • the control system 20 is configured to control the III 22 to enable a user to input a target 95.
  • the control system 20 is configured to control the III 22 to enable a user to specify prohibited regions 93, 94 through which the laser beam must not pass.
  • the control system 20 may control the III 22 such that assistance is provided in these tasks.
  • the control system 20 may use the results of the medical image processing to determine the boundary or boundaries of one or several prohibited region(s) 94.
  • At least one of the prohibited region(s) 94 may have a boundary coinciding with part of a 3D surface contour of the anatomical structure (e.g., of the mastoid portion).
  • the user needs to specify only part of a lumen containing tissue that must not be treated by the laser beam, and the control system 20 may be configured to then automatically determine the 3D volume that contains what has been specified by the user (which may be a point or a smaller volume) and extends to the 3D surface of the anatomical structure (e.g., of the mastoid portion).
  • the control system 20 may be configured to control the III 22 such that the user is enabled to input values for adjustable parameters of the laser ablation.
  • the III 22 may provide an input element 91 enabling the user to specify a safety margin distance 96.
  • the safety margin distance specifies a minimum spacing that is to be maintained between the laser-ablated tissue volume and any one of the prohibited region(s) 93, 94.
  • the III 22 may provide another input element 92 enabling the user to specify a diameter of a volume of hard tissue that is to be ablated by the laser beam.
  • the control system 20 may use the results of the image processing (e.g., a 3D surface contour of the mastoid portion) and the prohibited zones 93, 94 to automatically determine whether a trajectory 102 to the target 95 passes through the mastoid portion such that it is spaced by at least the safety margin distance 96 from all of the prohibited regions 93, 94. At least one of the prohibited regions 93, 94 may be a lumen through which the nervus facialis passes.
  • the control system 20 may use the results of the image processing (e.g., a 3D surface contour of the mastoid portion) and the prohibited zones 93, 94 to automatically determine whether a trajectory 104 to the target 95 passes through the mastoid portion such that it does not intersect any of the prohibited regions 93, 94 but is spaced by less than the safety margin distance 96 from at least one of the prohibited regions 93, 94.
  • the image processing e.g., a 3D surface contour of the mastoid portion
  • the prohibited zones 93, 94 may be used to automatically determine whether a trajectory 104 to the target 95 passes through the mastoid portion such that it does not intersect any of the prohibited regions 93, 94 but is spaced by less than the safety margin distance 96 from at least one of the prohibited regions 93, 94.
  • the control system 20 may use the results of the image processing (e.g., a 3D surface contour of the mastoid portion) and the prohibited zones 93, 94 to automatically determine whether a trajectory 106 to the target 95 passes through the mastoid portion and intersects at least one of the prohibited regions 93, 94.
  • the image processing e.g., a 3D surface contour of the mastoid portion
  • the prohibited zones 93, 94 may be used to automatically determine whether a trajectory 106 to the target 95 passes through the mastoid portion and intersects at least one of the prohibited regions 93, 94.
  • the various different trajectories 102, 104, 106 may be determined in response to a user input enabled by the III 22, which user input specifies an entry point on the outer bone surface or within the bone 101 , 103, 105 of the respective trajectory.
  • the control system 20 may be configured to control the III 22 such that different trajectories 102, 104, 106 are output in a visually distinguishable manner, depending on whether they intersect at least one prohibited region 93, 94.
  • the control system 20 may be configured to also control the III 22 such that different trajectories 102, 104, 106 are output in a visually distinguishable manner, depending on whether they have a distance at least equal to the safety margin distance from all of the prohibited regions 93, 94.
  • the different visually distinguishable representations may include color coded lines.
  • a trajectory 102 that passes to the target 95 through the mastoid portion and has a distance at least equal to the safety margin distance from all the prohibited region(s) 93, 94 may be displayed in a first style, e.g., a first color (such as green color) to indicate acceptability of the trajectory 102.
  • a trajectory 104 that passes to the target 95 through the mastoid portion and has a distance less than the safety margin distance from at least one prohibited region 93, 94 while not intersecting any of the prohibited regions 93, 94 may be displayed in a second style, e.g., a second color (such as orange color) to indicate a warning because the safety margin distance is not complied with for at least one of the prohibited regions.
  • a trajectory 106 that intersects at least one of the prohibited regions 93, 94 may be displayed in a third style, e.g., a third color (such as red color) to indicate non-acceptability.
  • Fig. 10 is a flow chart of a method 110.
  • the method 110 may be performed automatically by the surgical system 1 , e.g., by the control system 20 of the surgical system 1 .
  • the control system 20 controls the III 22 to enable a user input that specifies the target 95.
  • the user input may specify the target as a target point.
  • the target 95 may be or may comprise a target point.
  • the III 22 may be controlled such that the target 95 can be defined relative to a graphical representation of an anatomical structure (such as the mastoid portion).
  • the results of the processing of image data may be used in enabling the inputting of the target. For illustration, selection of a target 95 at a surface of the mastoid portion delimiting the tympanic cavity may be enabled if a tympanotomy is to be performed.
  • the surface of the mastoid portion delimiting the tympanic cavity may be determined by the control system 20 using image segmentation.
  • the control system 20 controls the III 22 to enable a user input that specifies one or several prohibited regions 93, 94.
  • the III 22 may be controlled such that the prohibited region(s) 93, 94 can be defined relative to a graphical representation of an anatomical structure (such as the mastoid portion).
  • the results of the processing of image data may be used in enabling the inputting of the prohibited region(s) 93, 94, as explained in detail above.
  • control system 20 controls the III 22 to enable a user input that specifies a safety margin distance.
  • the control system 20 controls the III 22 to output laser beam trajectories in a visually distinguishable manner, depending on how the laser beam trajectories are positioned relative to the prohibited regions 93, 94.
  • the surgical system and method may include a safety mechanism that switches off or blanks the laser beam 10 whenever a surface of hard tissue such as bone is reached.
  • the safety mechanism may be implemented in the laser beam generator 12 or control system 20.
  • the surgical system 1 may be enhanced with an override mechanism 36 which is configured to selectively override the safety mechanism when the laser ablation has reached a surface of a mastoid cell. This is illustrated in the Fig. 11 .
  • Fig. 11 shows a block diagram of components of the control system 20.
  • the safety mechanism 35 may be integrated in the control system 20 or the laser beam generator 12.
  • the override mechanism 36 may be configured to detect that the safety mechanism 35 takes action or is to take action for stopping laser ablation.
  • the override mechanism 36 may be configured to then selectively confirm that the surface reached by the laser ablation is a surface of a mastoid cell but is not a surface of the mastoid portion that delimits a lumen in which delicate tissue can be arranged.
  • the override mechanism 36 may enable the laser beam generator 12 to continue its laser ablation, as long as none of the prohibited regions 93, 94 is reached.
  • the techniques disclosed herein can be used to determine trajectories that are straight lines around which a cylindrical or frustoconical volume of hard tissue ablation extends.
  • the systems and methods disclosed herein are also applicable to more complex geometries of trajectories.
  • the systems and methods according to embodiments may be configured such that they can determine trajectories for laser radiation which include several straight segments arranged at an angle relative to each other (as explained with reference to Figure 12) and/or offset from each other in a direction transverse to a beam propagation direction (as explained with reference to Figure 13).
  • Figure 12 illustrates operation of a surgery planning system or method that determines a trajectory 130 from an entry point 110 into the hard tissue to the target 95.
  • the trajectory 130 includes two or more straight line segments 131 , 132.
  • the two or more straight line segments 131 , 132 are arranged at an angle relative to each other.
  • a position of an intermediate point 133 to which two of the two or more straight line segments 131 , 132 connect may be varied. This may be done automatically by the surgery planning system to automatically determine an optimum position of the intermediate point 133 (e.g., with respect to maximizing distances from the prohibited regions). Alternatively or additionally, the surgery planning system may enable the user to manipulate the position of the intermediate point 133 via the III 22. [00180] The surgery planning system may take into account the geometrical constraints when assessing whether the trajectory 130 is possible.
  • the diameter of both a first volume of tissue ablation around a first line segment 131 may be taken into account to ensure that a second volume of tissue ablation around a second line segment 132 can be ablated through the first volume of tissue ablation.
  • the surgery planning system may be configured to not only check that desired minimum distances from the one or several prohibited regions are maintained, but also to ensure that laser ablation remains possible along the various line segments that, in combination, form the trajectory 130.
  • FIG. 13 illustrates operation of a surgery planning system or method that determines several volumes 141 -144 of tissue ablation into the hard tissue to a target.
  • Each of the tissue ablation volumes 141 -144 may have a shape selected to be frustoconical or cylindrica.
  • the tissue ablation volumes 141 -144 may be arranged in an abutting or overlapping manner and may be offset from each other in a direction transverse to the center axes of the tissue ablation volumes, i.e. , transverse to the laser beam propagation direction.
  • a volume 140 having a non-frustoconical and non- cylindrical shape can be ablated.
  • the volume 140 can define a non-circular opening in hard tissue surfaces. This allows the tissue ablation volume to be tailored to the needs of the access that is formed in the respective case.
  • color coding may be used to output different laser trajectories in a visually distinguishable manner, other visually distinguishable representations may be used.
  • control system may be configured to control the laser beam generator and robot arm to perform an antrostomy, a mastoidectomy, mastoidectomy templating, a tympanotomy
  • the surgical system may be configured to perform additional or alternative procedures.
  • the surgical system may be implemented as a surgical robot that, once started to perform a procedure, acts with a high degree of autonomous decision making, the surgical system may also be an assistance system that assists a surgeon through part of a surgery.
  • the techniques disclosed herein are not limited to removal of hard tissue.
  • the techniques may be used for performing or planning removal of combinations of hard and soft tissue, such as tissue that includes both hard tissue (e.g., bone) and cancerous tissue.
  • a computer program may be stored/distributed on a suitable medium, such as an optical storage medium or a solid-state medium supplied together with or as part of other hardware, but may also be distributed in other forms, such as via the Internet or other wired or wireless telecommunication systems.
  • a computer program can be a computer program product stored on a computer readable medium which computer program product can have computer executable program code adapted to be executed to implement a specific method such as the method according to the invention.
  • a computer program can also be a data structure product or a signal for embodying a specific method such as the method according to the invention.

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  • Health & Medical Sciences (AREA)
  • Surgery (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Medical Informatics (AREA)
  • General Health & Medical Sciences (AREA)
  • Biomedical Technology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Molecular Biology (AREA)
  • Animal Behavior & Ethology (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • Robotics (AREA)
  • Physics & Mathematics (AREA)
  • Optics & Photonics (AREA)
  • Electromagnetism (AREA)
  • Otolaryngology (AREA)
  • Laser Surgery Devices (AREA)

Abstract

Un système chirurgical (1) comprend un outil chirurgical, un bras de robot (11) sur lequel l'outil chirurgical est agencé, et un système de commande (20) conçu pour actionner le bras de robot (11) et l'outil chirurgical, et pour recevoir des données d'image médicale d'un sujet (19), les données d'image médicale représentant un volume contenant au moins une partie d'un os temporal du sujet (19). L'outil chirurgical comprend un générateur de faisceau laser (12) conçu pour émettre un faisceau laser (10) afin de permettre l'ablation d'un tissu dur tel qu'un os. Le système de commande (20) est conçu pour évaluer les données d'image médicale et pour utiliser les données d'image médicale évaluées pour amener le générateur de faisceau laser (12) à émettre le faisceau laser incident sur une partie mastoïde de l'os temporal.
PCT/EP2023/083033 2022-11-25 2023-11-24 Système chirurgical Ceased WO2024110646A1 (fr)

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