WO2022103254A1 - Dispositif, procédé et système d'aide au chirurgien pendant une opération - Google Patents

Dispositif, procédé et système d'aide au chirurgien pendant une opération Download PDF

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Publication number
WO2022103254A1
WO2022103254A1 PCT/NL2021/050676 NL2021050676W WO2022103254A1 WO 2022103254 A1 WO2022103254 A1 WO 2022103254A1 NL 2021050676 W NL2021050676 W NL 2021050676W WO 2022103254 A1 WO2022103254 A1 WO 2022103254A1
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WO
WIPO (PCT)
Prior art keywords
haptic
surgeon
tool tip
location
feedback device
Prior art date
Application number
PCT/NL2021/050676
Other languages
English (en)
Inventor
Wouter Karel Vos
Herke Jan NOORDMANS
Sander Jozef Herman DIEDEREN
Eduard VOORMOLEN
Original Assignee
Elitac B.V.
Universiteit Utrecht Holding B.V.
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 Elitac B.V., Universiteit Utrecht Holding B.V. filed Critical Elitac B.V.
Publication of WO2022103254A1 publication Critical patent/WO2022103254A1/fr

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • 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
    • A61B34/20—Surgical navigation systems; Devices for tracking or guiding surgical instruments, e.g. for frameless stereotaxis
    • 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
    • A61B34/70—Manipulators specially adapted for use in surgery
    • A61B34/76—Manipulators having means for providing feel, e.g. force or tactile feedback
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B90/00—Instruments, implements or accessories specially adapted for surgery or diagnosis and not covered by any of the groups A61B1/00 - A61B50/00, e.g. for luxation treatment or for protecting wound edges
    • A61B90/10—Instruments, implements or accessories specially adapted for surgery or diagnosis and not covered by any of the groups A61B1/00 - A61B50/00, e.g. for luxation treatment or for protecting wound edges for stereotaxic surgery, e.g. frame-based stereotaxis
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B2017/00017—Electrical control of surgical instruments
    • A61B2017/00115—Electrical control of surgical instruments with audible or visual output
    • A61B2017/00119—Electrical control of surgical instruments with audible or visual output alarm; indicating an abnormal situation
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B90/00—Instruments, implements or accessories specially adapted for surgery or diagnosis and not covered by any of the groups A61B1/00 - A61B50/00, e.g. for luxation treatment or for protecting wound edges
    • A61B90/20—Surgical microscopes characterised by non-optical aspects

Definitions

  • the invention relates to a device, method and system for aiding a surgeon while operating. More specific, the invention relates to a device, method and system for aiding a surgeon in guiding an invasive tool into the body of a patient.
  • a medical system includes a medical implement, a manipulator controllable by an operator for control of the medical implement at an anatomic body site and a sensing device for sensing a non-visible field associated with a body structure at the site.
  • a controller intercoupling the sensing device and the manipulator, includes a mapping component for translating characteristics of the sensed field signal into a tactile feedback signal to the manipulator to warn the surgeon that he is approaching this structure with the implement.
  • a virtual image of the body structure is displayed, separate or preferably together with a visual image of the site, to assist a surgeon in manipulating a medical implement.
  • a method includes creating a Three-Dimensional (3D) model of a patient using at least one image of an affected area of the patient. Surgical paths are retrieved for performing a surgical procedure. A surgical path, selected by a surgeon, may be displayed as overlaid on the 3D model. A haptic barrier and a hard barrier may be defined for different types of tissues and feedbacks may be associated with the haptic barrier and the hard barrier. Position of a surgical tool of a robotic surgical system may be monitored in real-time during a surgical procedure. Movement of the surgical tool into one of the haptic barrier and the hard barrier may be detected and a suitable feedback may be provided, based on the movement.
  • 3D Three-Dimensional
  • WO 2018/076094 discloses a 3D navigation system and methods for enhancing feedback during a medical procedure, involving: an optical imaging system having an optical assembly comprising movable zoom optics and movable focus optics, a zoom actuator for positioning the zoom optics, a focus actuator for positioning the focus optics, a controller for controlling the zoom actuator and the focus actuator in response to received control input, at least one detector for capturing an image of at least one of a target and an obstacle, the at least one detector operable with the optical assembly, and a proprioception feature operable with the optical imaging system for generating a 3D perception, the proprioception feature comprising a communication feature for providing 3D information, the 3D information comprising real-time depth information in relation to real-time planar information within an interrogation volume.
  • WO 2019/204611 discloses an apparatus has a device representing an endoscope, the device being either an endoscope or a dummy endoscope having shape and feel resembling an endoscope, and includes a tracker adapted to operate with a three-dimensional tracking system to track location and orientation of the device in three dimensions in a simulated operating-room environment.
  • the apparatus also has a physical head model comprising hard and soft components, the device representing an endoscope configured to be inserted into the physical head model to provide a haptic feedback of endoscopic surgery.
  • US 2015/182288 discloses a method for implanting a spinal plate includes the steps of displaying information about target vertebrae on which the implantation is to be performed and inserting a spacing device between two adjacent vertebrae to achieve a desired relationship there between. The method further includes planning placement of the spinal plate to achieve a desired relationship between the two adjacent vertebrae and defining a virtual cutting boundary on a virtual representation of each of the first and the second vertebrae according to the planned placement of the spinal plate.
  • the method further includes tracking the vertebrae using a tracking array and tracking a position of a cutting tool held by a force feedback device as the tool is manipulated to form a sculpted cavity independently on each vertebrae for receiving the spinal plate, and providing force feedback to the user indicative of interaction between the tool and the virtual cutting boundary.
  • a disadvantage is that the surgeon has to switch his field of view between the area operated on and the screen showing his tools and the vital structures.
  • the current haptic feedback does at least not provide a direction to the nearest critical structure.
  • the current haptic feedback system fails to facilitate the invasive procedure sufficiently and/or satisfactorily enough to be effectively used during an operation.
  • a haptic feedback device arranged for being part of a guidance system for aiding a surgeon during an invasive procedure on a body, wherein the haptic feedback device comprises:
  • - haptic actuators arranged for having a spatial arrangement defining a haptic interaction surface, and for being in haptic communication with the surgeon;
  • a surgeon operating on the body of a patient may have to invade the body with a tool.
  • This tool such as a drill, may be used to get to a specific location and/or may be used at a specific location.
  • the surgeon may be a neurosurgeon.
  • a neurosurgeon may be operating on the brain typically has to go through the skull.
  • a neurosurgeon may also be operating on the skull itself.
  • the skull comprises critical structures, such as veins and nerves. These critical structures are typically soft and easily damaged. When operating on the skull and/or going through the skull, bone matter may need to be removed from the skull by a drill.
  • the body is typically a patient, more specific a human patient.
  • the surgeon is typically a neurosurgeon.
  • the typical invading procedure is an operation on the brain where there is a need for drilling through the skull, and/or an operation on the skull itself.
  • the guidance system typically comprises a microscope wherethrough the surgeon may view the area of the body operated on, or at least the entrance in the body wherethrough the area of the body operated on is accessible.
  • the viewing direction of the microscope is such that the area operated on is visible through the microscope.
  • the guidance system may further comprise a tool addon sensing the orientation and location of the tool attached to it.
  • a tool addon sensing the orientation and location of the tool attached to it.
  • the body is fixated to make sure the body is not moving.
  • the addon and/or the tool attached whereto the addon is attached is calibrated, such that the guidance system detects and/or calculates the location and/or orientation of the tool, especially a specific point or volume of the tool, relative to the body.
  • identification may be done real-time or almost real-time. In an alternative embodiment, identification may be done alternating with the actual invasive procedure.
  • the guidance system may further comprise a screen visualizing the scan of the body and the tool, specifically the tool tip.
  • the screen provides the surgeon with a 2D view of the body and its structures, such as critical and/or vital structures, and the tool, specifically the tool tip.
  • the haptic feedback device comprises haptic actuators.
  • the haptic actuators are arranged for having a spatial arrangement defining a haptic interaction surface.
  • the haptic interaction surface is typically substantially flat.
  • the haptic interaction surface typically follows the curvature of the body of the surgeon to be in haptic communication with the surgeon.
  • the haptic feedback device comprises a controller.
  • the controller is typically loaded with software.
  • the controller may be centralized or distributed.
  • the controller may be arranged or loaded with software for executing several steps.
  • the steps may be executed in any order.
  • the steps may be repeated over the course of the operation. One step may be repeated more than the other step.
  • the controller is arranged for the step of retrieving information on locations of critical structures in an area of the body.
  • This information is typically provided by another part of the guidance system.
  • This other part of the guidance system may be a database.
  • this information may be provided by an external source, such as an external database e.g. from a hospital database system.
  • the locations of the critical structures in the body are represented by 3D information.
  • the critical structures are typically represented as a volume in this 3D space.
  • the critical structures are typically specified relative to stable reference points in the body.
  • Stable reference points in the body may be a bone structure, such as notches in or protrusions from a bone. When operating on the skull, typically notches in and protrusions from the skull are selected as stable reference point.
  • the same reference points are typically used during scan as well as during the invasive procedure, such as an operation.
  • the controller is arranged for the step of retrieving information on the spatial arrangement of the haptic actuators.
  • This information may be predefined or prestored in memory associated with the controller.
  • the information is typically the relative position of the haptic actuators to each other. Typically, the relative positions are within the haptic interaction surface. As reference for the relative positions one haptic actuator may be selected. Alternatively, as reference for the relative positions an arbitrary point is selected. This arbitrary point is typically a logical point in relation to the pattern that the haptic actuators form. For example, if at least a selection of the haptic actuators is arranged in the shape of a circle, the arbitrary reference point may be selected on a side or corner of a square enveloping or even touching the circle. For example, if at least a selection of the haptic actuators is arranged in the shape of a circle, the arbitrary reference point may be selected as the centre of this circle.
  • the controller is arranged for the step of receiving a tool tip location indicative of a location of a tool tip of an invasive tool used for invading a body area of the body during the invasive procedure in an invading direction.
  • the tool tip is arranged for being thrusted forward in and/or sideward from the invading direction.
  • the tool tip location is typically provided by other parts of the guidance system.
  • the controller is arranged for the step of selecting a nearest critical structure of the critical structures relative to the tool tip location.
  • the controller may do the selection based on the 3D coordinate of the tool tip and the 3D coordinates of the critical structures relative to reference points.
  • the steps of retrieving information on locations of critical structures in an area of the body, and selecting a nearest critical structure of the critical structures relative to the tool tip location are replaced with the step of receiving a nearest critical structure of the critical structures relative to the tool tip location.
  • the step of receiving a nearest critical structure may be serviced by another part of the guidance system, which is executing the replaced steps.
  • the controller is arranged for the step of projecting a direction of the nearest critical structure onto the haptic interaction surface.
  • a direction is a 3D vector, typically the normalized 3D vector. This 3D vector may be projected on a 2D haptic interface surface. Several projections may be suitable to convey the information via vibrations in the haptic interface surface to the surgeon.
  • the controller is arranged for the step of actuating one or more of the haptic actuators based on the projection. This step effectively conveys the information to the surgeon.
  • the actual vibration thus represents the direction starting out from the tool tip towards the nearest structure information.
  • the haptic feedback device provides an alternative means for perceiving the nearest critical structure for the surgeon.
  • the surgeon typically uses the screen of the guidance system for visually perceiving the location of the tool tip relative to critical structures.
  • the surgeon while guiding and/or manoeuvring the tool, especially the tool tip, typically has to swap between the screen and viewing the operating area typically via a microscope.
  • the haptic feedback device allows the surgeon to swap less or even not swap anymore between screen and operating area. Less swapping or even not swapping may have the effect of decreasing unintended movement by the surgeon of the tool tip due to this swapping, thus decreasing the likelihood of unintended damaging of critical structures. Less swapping or even not swapping may have the effect of lessening the stress, physically and/or mentally, for the surgeon.
  • the screen visualizing the tool, specifically the tool tip, and the surrounding critical structures is a 2D visualization of 3D space.
  • the screen typically provides a limited insight in the distance between the tool tip and the surrounding critical structures.
  • One critical structure may be shown more distant relative to another critical structure in relation to the tool tip on the screen, but in reality, this one critical structure may actually be closer to the tool tip. This confusion and/or loss of sense of distance between the critical structures and the tool, specifically the tool tip, is advantageously mitigated by the haptic feedback device.
  • the spatial arrangement of the haptic actuators is a 2D spatial arrangement.
  • the 2D spatial arrangement is advantageously curved to fit to the body of the surgeon.
  • the spatial arrangement is typically held together or placed upon a resilient material, such as a resilient plastic or fabric e.g. of some clothing.
  • the spatial arrangement more specific the 2D spatial arrangement, advantageously covers a 2D area.
  • the guidance system comprises a microscope for displaying to the surgeon at least partly a body surface of the body area invaded, having a viewing direction; and the controller is arranged for receiving a viewing direction; and the projecting is based on the viewing direction.
  • the viewing direction of the surgeon may advantageously be derived from the settings, such as the orientation, of the microscope relative to the body operated on or invaded by a tool.
  • the microscope may advantageously be linked or calibrated relative to the operating table carrying the body or to a frame holding the body.
  • the guidance system may relate these two values relative to each other.
  • the guidance system may insert the tool tip location and the viewing direction into the frame of reference of the critical structures for advantageously using the viewing direction for projecting.
  • projecting comprises:
  • the semisphere is typically a unity sphere.
  • the semisphere location is the crossing of a line segment starting at the tool tip and extending along the vector and the semisphere up to the nearest critical structure.
  • the semisphere advantageously allows to map the semisphere location having a uniform distance from the tool tip, such as unity distance, onto the haptic location of the haptic interaction surface.
  • An alternative definition of the location of the semisphere may be that the semisphere is located on the opposite or other side of the equator plane relative to the viewing direction.
  • the vector may be mirrored in the equator plane as part of calculation step for obtaining a semisphere location.
  • mapping is advantageously based on:
  • a near-side general perspective such as a GEO, a MEO or a LEO nearside general perspective, preferably based on a focal point in the range of 0.01 to infinity, more preferably in the range of 0.02 to10, most preferably around 0.05, 1 or 5.62;
  • a far-side general perspective such as a Twilight, a Clarke, a James or La Hire far-side general perspective
  • - a projection based on a focal point in the range of -6 to 0.3, more preferably in the range of -4 to 0.5, most preferably around -2.7, -2.5, -2.4, -2, -1 .7 or - 1.
  • the mapping advantageously is one of the group of a stereographic projection, an orthographic projection, an azimuthal projection, and a Lambert azimuthal equal-area projection.
  • the azimuthal equidistant projection has shown to be specifically beneficial during tests.
  • the haptic interaction surface has a circumference, which is substantially a circular surface.
  • a circle on the semisphere can be defined by the set of crossings of the semisphere and line segments extending from the tool tip location and in directions having an equal angle relative to the viewing direction. This circle is parallel to the equator plane.
  • the direction of the viewing direction is advantageously mapped onto the centre of the substantially circular surface.
  • the substantially circular surface of the haptic interaction surface provides the advantage that the mapping step will cause the points on the circle to be mapped at equal distance from the centre point of the substantially circular surface. This in turn provides the advantage that the haptic sensation of the surgeon is independent of where the direction crosses this circle on the semisphere pointing to the nearest critical structure to perceive the same deviation from the centre of the haptic interaction surface.
  • the haptic actuators are arranged to predefined locations in the haptic interaction surface.
  • the haptic location on the haptic interaction surface is typically not at one of the predefined locations of the actuators.
  • the haptic location may be mapped to the closest actuator, whereafter the closest actuator is activated. Although simple in its solution, this also provides a relatively low haptic accuracy.
  • two, three or more actuators may be activated for interpolating between the activated actuators.
  • the interpolation between the activated actuators advantageously allows to provide a haptic sensation at the haptic location while none of the activated actuators is arranged to this haptic location.
  • the interpolation calculation is advantageously simplified.
  • actuating comprises actuating two or more haptic actuators for perceiving a haptic actuation signal by the surgeon at the haptic location.
  • the step of actuating typically comprises interpolating between different haptic actuators, preferably between three haptic actuators positioned in a triangle, for simulating a haptic location between the position of the haptic actuators.
  • the haptic actuators are typically arranged such close together that the haptic actuators may be used for interpolation. If the haptic actuators are arranged too far away from each other, the haptic actuators will be perceived as individual haptic actuators.
  • the haptic actuators are typically arranged far enough apart such that the arrangement of haptic actuators cover a substantial area. The larger the covered area the higher the accuracy of the direction the surgeon may distinguish. Further, the less haptic granularity and/or actuators are used, the simpler the control of these different actuators and/or the complexity of the haptic feedback device in general. Thus, the distance between the haptic actuators is a balance between the aforementioned effects and advantages.
  • the haptic interaction surface is advantageously divided up in triangles forming the substantially circular haptic surface.
  • Haptic actuators are arranged to the corners of the triangles.
  • the triangles are advantageously arranged such that the comers of the different triangles are adjacent, such as in a Delaunay triangulation.
  • calculating comprises if the nearest critical structure is located above the equator plane with regard to the viewing direction, placing the semisphere location on the rim of the semisphere. Typically, from the tool tip location the intention is to drill sideways of or in the viewing direction. If the nearest critical structure is above the equator plane, more specific above the tool tip location, it should be indicated that e.g. the tool tip is not lifted upwards against the viewing direction. To prevent this lifting upwards, the semisphere location is advantageously placed on the rim of the semisphere.
  • the rim of the semisphere may coincide with the rim of the haptic interaction surface in this embodiment.
  • a typical reaction is to move the tool tip in a direction in the equator plane away from the semisphere location, which is located on the rim of the semisphere.
  • the semisphere location may be the same as the haptic location, which is located on the edge of the haptic interaction surface rim in this case.
  • the tool tip is advantageously moved away from below the nearest critical structure.
  • another possible reaction is to retract the tool tip backwards along the elongated axis of the tool. After the retraction, the equator plane, as it is relative to the retracted tool tip location, may place the nearest critical structure below the equator plane allowing to get a better sense of the location of the nearest critical structure.
  • Another possible reaction is to not retract, but continue to move the tool tip down along the viewing direction or sideways from the viewing direction, except for the sideway direction indicated by the semisphere location on the rim. This allows to continue operating, such as drilling with the tool tip, and being confident that no critical structure is damaged. And when done, retracting along the elongated axis of the typically elongated tool should not damage any critical structures as described above.
  • the haptic actuators are advantageously arranged for being in haptic communication with the back of the surgeon.
  • the back of the surgeon is a relatively large and substantially flat or lightly curved surface. The surgeon typically bends over during the invasive procedure, leaving the front with too many wrinkles and curves or even insensitive to haptic communication.
  • the back of the surgeon is typically stretched and/or flattened, advantageously allowing haptic communication.
  • the haptic actuators are advantageously arranged for being on both sides of the spine in haptic communication with the surgeon.
  • the spine is relatively insensitive to haptic communication, such as vibrations.
  • the spine is an indentation relative to other parts of the back, requiring additional measures to have haptic actuators at this position in haptic communication with the back of the surgeon. These additional measures are prevented, thus simplifying the haptic feedback device.
  • the haptic actuators are advantageously arranged for being symmetrical around the spine in haptic communication with the surgeon. This symmetry simplifies the actuation of the haptic actuators. This symmetry prevents different interpolation perceptions for left and right from the spine. As the haptic feedback device is typically worn, symmetry typically allows and/or is perceived as a more comfortable fitting to the body.
  • the arrangement of haptic actuators advantageously comprises 10, 12, 14, or 16 haptic actuators.
  • These arrangements typically allow for the haptic actuators to be arranged in triangles, such as: near equilateral triangles and/or more or less equally sized triangles; symmetry around the spine; a balance between a large haptic interaction surface and interpolation between the haptic actuators, advantageously arranging such that the arrangement complies to the Delaunay triangulation requirements; haptic actuators to be arranged to substantially cover a circular area and/or low complexity of the haptic feedback device due to the low amount of haptic actuators, specifically less than or equal to 16, which may be coded in a nibble in software, or in case of one hot in two bytes.
  • projecting comprises:
  • the distance may advantageously be incorporated in the activation pattern. This advantageously allows the surgeon to decide if it is still possible to move the tool tip in the direction of the nearest critical structure or not. This may especially be advantageous if the surgeon is e.g. making a hole or an opening in a skull for providing a large access area to the area to be further operated on.
  • the activation pattern comprises one or more of the group of a vibration frequency, a vibration amplitude, a vibration activation duration and a vibration activation interval.
  • the semisphere location and/or the haptic location is used as indication for the direction of the nearest critical structure, other options at this semisphere location and/or this haptic location should be advantageously used to convey the distance information. These other options are advantageously summarized as activation pattern.
  • a guidance system for aiding a surgeon during an invasive procedure on a body comprising critical structures wherein the system comprises:
  • an invasive tool for invading a body area of the body during the invasive procedure in an invading direction, wherein the invasive tool is having a tool tip arranged for being thrusted forward in and/or sideward from the invading direction, which tool tip has a tool tip location;
  • haptic feedback device comprising haptic actuators arranged for being in haptic communication with the surgeon wherein actuation of the haptic actuators is indicative of a direction based on, and preferably a distance between, the tool tip and a nearest critical structure of the critical structures.
  • a method for a haptic feedback for a guidance system for aiding a surgeon during an invasive procedure on a body comprising:
  • the preceding method advantageously combined with any of the features of the haptic feedback device according to the invention.
  • a system comprising a microprocessor arranged and loaded with software for carrying out any of the methods according to the invention.
  • This aspect of the invention provides the advantages as specified for the other aspects of the invention.
  • a computer program product comprising a computer readable medium having computer readable code embodied therein, the computer readable code being configured such that, on execution by a suitable computer or processor, the computer or processor is caused to perform the method specified in an embodiment according to the invention.
  • Figure 1 schematically shows an operating theatre
  • Figure 2 schematically shows a haptic feedback method
  • Figure 3 schematically shows the step of projecting
  • Figure 4 schematically shows an embodiment of the step of mapping
  • Figure 5 schematically shows an embodiment of the step of mapping
  • Figure 6 schematically shows an embodiment of the step of mapping
  • Figure 7 schematically shows an embodiment of an arrangement of haptic actuators
  • Figure 8 schematically shows an embodiment of an arrangement of haptic actuators
  • Figure 9 schematically shows an embodiment of an arrangement of haptic actuators
  • Figure 10 schematically shows an embodiment of an arrangement of haptic actuators
  • Figure 11 schematically shows an embodiment of an arrangement of haptic actuators
  • Figure 12 schematically shows an embodiment of a computer program product, computer readable medium and/or non-transitory computer readable storage medium according to the invention.
  • the figures are purely diagrammatic and not drawn to scale. In the figures, elements which correspond to elements already described may have the same reference numerals.
  • FIG. 1 schematically shows an operating theatre 10.
  • the operating theatre may comprise a patient 20 and a surgeon 30 operating on the patient.
  • the surgeon may use a guidance system 200 for guiding him during the operation.
  • An example of such a guidance system is the Stealth system of Medtronic, Cranial Navigation Application of Brainlab, Navigation of Stryker, or Cranial or Spine Navigation of 7D Surgical.
  • the guidance system may comprise an invasive tool 210 and a haptic feedback device 100.
  • the surgeon will view 250 the part of the body of the patient operated on through a microscope 240. The surgeon is therefore looking 245 into the microscope.
  • the surgeon will manipulate 215 the invasive tool.
  • the invasive tool will in response to this manipulation move 220 typically in the body of the patient.
  • the translation of manipulation to movement may be direct or indirect. Indirect may be that the manipulations are fed through control software and/or mechanical controllers for e.g. stabilizing, translating, rotating and/or scaling the manipulations.
  • the haptic feedback device is typically in haptic communication 115 with the surgeon for providing haptic feedback to the surgeon during the operation.
  • the haptic feedback device takes as input the viewing direction 105 of the surgeon typically from the microscope.
  • the haptic feedback device takes further as input the tool tip location 110 provided by the invasive tool or derived from the invasive tool by the guidance system.
  • the guidance system may optionally comprise a screen typically showing the invasive tool, especially the invasive tool tip, and/or the critical structures in the operating area.
  • the critical structures may be selected as only showing the nearest or few of the nearest critical structures. The surgeon may look on the screen to prevent damaging the critical structures with the invasive tool, especially the invasive tool tip.
  • the haptic feedback device has the effect to provide the surgeon with a feedback allowing the surgeon to not take his eyes of or take his eyes less from the operating area. This effect is due to that the haptic feedback uses a different sense organ than the eyes.
  • the haptic feedback allows the surgeon to less swap or not swap at all with his eyes and therefore reduces the change on damaging a critical structure of the patient.
  • the effect of the haptic feedback device is to reduce the change of damaging critical structures in the patient by the surgeon.
  • the screen provides a 2D view of a 3D situation.
  • This changing of perspective increases the issue of or chance on unwillingly wavering of the invasive tool of the surgeon.
  • the effect of the reduction of the change from the haptic feedback device is increased.
  • this 2D view limits to estimate the distance between the tool tip location and the nearest critical structure, this cause inaccuracies in the distance estimation by the surgeon.
  • the estimation of this distance is improved by providing the surgeon with the haptic feedback.
  • the effect of this improved estimation is that the change that the surgeon damages a critical structure of the patient is reduced.
  • FIG. 2 schematically shows a haptic feedback method 300.
  • the method may be implemented in a controller of a haptic feedback device.
  • the method starts with retrieving 310 information on locations of critical structures in an area of the body.
  • the retrieving of this information may come from a database.
  • This database may be part of a guidance system or part of a hospital information system.
  • This information is typically coming from a scan, such as an MRI, done prior to the operation.
  • this scanning may be done during the operation in real-time or almost real-time.
  • the haptic feedback device or method according to the invention may be used also in the softer tissue where the critical structures have some mobility.
  • the method may continue with the step of retrieving 315 information on the spatial arrangement of haptic actuators.
  • This information is typically predefined.
  • the haptic arrangement may calibrate the distances between the haptic actuators based on the transmission of vibrations during a calibration procedure at start-up.
  • the haptic actuators define a haptic interaction surface.
  • the haptic surface is typically resilient to follow the curvature of the body of the surgeon.
  • the haptic actuators are arranged for being in haptic communication with the surgeon.
  • the method may continue with the step of receiving 320 a tool tip location.
  • the tool tip location is indicative of a location of a tool tip of an invasive tool used for invading a body area of the body during the invasive procedure, such as a surgery, in an invading direction.
  • the tool tip is arranged for being thrusted forward in and/or sideward from the invading direction.
  • the tool tip may be a drill for e.g. drilling away bone of the skull for gaining access to the brain and/or parts of the skull.
  • a drill for this type of drilling is typically most effective drilling sideways and has limited drilling effectiveness drilling straight forward from the elongated axis of the drill.
  • the tool tip is typically a volume, such as the point of a drill.
  • the tool tip location is therefore typically a volume representing the tool tip.
  • the distance between the nearest critical structure and the tool tip therefore becomes the smallest distance between a volume representing the nearest critical structure and the volume of the tool tip.
  • the method may continue with the step of selecting 325 a nearest critical structure of the critical structures relative to the tool tip location.
  • the critical structures are typically represented by different volumes. Depending on the granularity of the information on the critical structures, these critical structures are represented in memory by more data requiring more calculations.
  • the method may continue with the step of projecting 330 a direction of the nearest critical structure onto the haptic interaction surface.
  • the projecting step may be done in multiple ways as specified throughout this description. Depending on the way of projecting the accuracy for different directions is kept stable or may vary with several advantages.
  • the method may continue with the step of actuating 335 one or more of the haptic actuators based on the projection.
  • the actuation may comprise interpolating between haptic actuators for providing a higher granularity of the haptic feedback communication.
  • the steps in the method may be done in parallel.
  • the order of the steps is randomly chosen unless the order is determined by the flow of information. Steps may be performed multiple times in comparison to other steps of the method.
  • Figure 3 schematically shows the step of projecting 330.
  • the projecting may be done with the use of a sphere having a top half 445 and a bottom half 440.
  • Figure 3 is therefore a cross section of the sphere.
  • the surgeon 30 looks with his eye 35 typically through a microscope 240.
  • the surgeon may further manipulate an invasive tool 210 having a tool tip having a tool tip location 110.
  • the line segment from the eye of the surgeon to the tool tip location and beyond is the viewing direction 105.
  • an equator plane 415 is shown.
  • the equator plane is shown at the level of the tool tip location 110.
  • the half of the sphere closest to the eye of the surgeon is the top half of sphere 445, the half of the sphere furthest away from the eye of the surgeon is the bottom half of the sphere 440.
  • the eye of the surgeon may have a field of view having boundaries forming a viewing cone 37, 37’ having a focal point 36 at the eye of the surgeon.
  • the radius of the sphere may be determined by or derived from the viewing cone or predefined as 1 . If the radius is predefined and/or set to one, the size of the haptic surface might have to be scaled to fit onto the area covered by the haptic actuator arrangement.
  • the figure further shows a nearest critical structure 420.
  • the line segment between the tool tip location 110 and the nearest critical structure 420 has a direction 425, which may be normalized to a unit vector 430 relative to the sphere.
  • the semisphere location 450 on the sphere pointed at by the unit vector is the projection of the nearest critical structure on the bottom half of the sphere.
  • the last step of projection may be mapping of the semisphere location onto the haptic interaction surface.
  • the haptic interaction surface may be represented by the equator plane, but may also be represented by surfaces positioned elsewhere, but typically perpendicular to the viewing direction.
  • the haptic interaction surface is advantageously oriented such that it is prevented that the surgeon does have to mentally rotate the haptic surface to match his field of view.
  • a direction above the tip location with regard to the field of view of the surgeon is shown on the haptic surface above the centre point of the haptic surface, such as higher up on the back of the surgeon.
  • the orientation of the field of view of the surgeon, specifically the orientation of the microscope, may be provided by the guidance system.
  • Figure 4 schematically shows an embodiment of the step of mapping 500.
  • the radius 505 of the sphere equals the sides of the mapping 510, 51 O’.
  • Figure 4 is therefore a cross section of the sphere.
  • the sides of the mapping define the edge of the haptic interaction surface 520, and form a cylinder.
  • the mapping has a focal point at infinity.
  • the vectors 525, 525’, 525” indicate arbitrary mappings shown as examples.
  • Each of the vectors ends at a specific point 526, 526’, 526” on the bottom half of the semisphere 440. This specific point indicates a specific direction.
  • each of the vectors has a specific intersection 527, 527’, 527” with the haptic interaction surface.
  • Each of these intersections specifies a specific mapping from a specific direction to a specific intersection, which is a one-to-one mapping or unambiguous mapping.
  • This mapping may be labelled as orthographic mapping.
  • Figure 5 schematically shows an embodiment of the step of mapping 550.
  • Figure 5 is therefore a cross section of the sphere.
  • the sides of the mapping 510, 510’ define the edge of the haptic interaction surface 520, and form a cone.
  • the mapping has a focal point 530 at a radius distance from the sphere.
  • the distance between the focal point and the centre of the sphere is two times the radius of the sphere.
  • Alternative distances between the focal point and the centre of the sphere are possible.
  • the vectors 525, 525’, 525” indicate arbitrary mappings shown as examples. Each of the vectors ends at a specific point on the bottom half of the semisphere 440, similar to Figure 4. This specific point indicates a specific direction.
  • each of the vectors has a specific intersection with the haptic interaction surface, similar to Figure 4.
  • Each of these intersections specifies a specific mapping from a specific direction to a specific intersection, which is a one-to-one mapping or unambiguous mapping.
  • This mapping may be labelled as MEO near-side general perspective mapping.
  • a disadvantage of this mapping may be that the bottom part of the semisphere cannot unambiguously mapped. The bottom part of the semisphere is used to indicate directions which are close to parallel to or at a shallow angle with the equator plane.
  • Figure 6 schematically shows an embodiment of the step of mapping 560.
  • the sides of the mapping 510, 510’ define the edge of the haptic interaction surface 520, and form a cone.
  • the mapping has a focal point 530 at minus two and a half times the radius of the sphere.
  • the distance between the focal point and the centre of the sphere is minus one and a half times the radius of the sphere.
  • Alternative distances between the focal point and the centre of the sphere are possible.
  • the vectors 525, 525’, 525” indicate arbitrary mappings shown as examples. Each of the vectors ends at a specific point of the haptic surface 520, in contrast to Figure 4. This specific point indicates a specific direction.
  • each of the vectors has a specific intersection with the haptic interaction surface, similar to Figure 4.
  • Each of these intersections specifies a specific mapping from a specific direction to a specific intersection, which is a one-to-one mapping or unambiguous mapping for the larger and/or important part of the directions.
  • This mapping may be labelled as James far- side general perspective mapping. Note that specifically around the edge of the semisphere and/or the edge of the haptic surface the mapping may become ambiguous depending on the selected mapping.
  • mappings are foreseen by the inventor and are within the scope of the invention.
  • Figure 7 schematically shows an embodiment of an arrangement of haptic actuators 600.
  • This arrangement has 12 vertices forming 13 triangles.
  • the number of vertices equals the number of haptic actuators located at the vertices.
  • the triangles identify the areas of interpolation for the three haptic actuators located at the comers or respective vertices of the triangle.
  • Figure 8 schematically shows an embodiment of an arrangement of haptic actuators 601 .
  • This arrangement has 10 vertices forming 10 triangles. Rotating this arrangement slightly left or right allows to place this arrangement substantially symmetrically around the spine.
  • Figure 9 schematically shows an embodiment of an arrangement of haptic actuators 602.
  • This arrangement has 14 vertices forming 16 triangles. Rotating this arrangement left or right allows to place this arrangement substantially symmetrically around the spine. It is further noted that the triangles of this arrangement are substantially the same shape and/or size providing the advantage of similar perception of the interpolation.
  • Figure 10 schematically shows an embodiment of an arrangement of haptic actuators 603. This arrangement has 16 vertices forming 20 triangles.
  • Figure 11 schematically shows an embodiment of an arrangement of haptic actuators 604.
  • This arrangement has 12 vertices forming 14 triangles. Without rotating this arrangement may be placed substantially symmetrically around the spine. It is further noted that the triangles of this arrangement are substantially of the same shape and/or size providing the advantage of similar perception of the interpolation.
  • Figure 12 schematically shows an embodiment of a computer program product 1000, computer readable medium 1010 and/or non-transitory computer readable storage medium comprising computer readable code 1020 according to the invention.
  • the invention also applies to computer programs, particularly computer programs on or in a carrier, adapted to put the invention into practice.
  • the program may be in the form of a source code, a code intermediate source and an object code such as in a partially compiled form, or in any other form suitable for use in the implementation of the method according to the invention.
  • a program may have many different architectural designs.
  • a program code implementing the functionality of the method or system according to the invention may be sub-divided into one or more sub-routines. Many different ways of distributing the functionality among these sub-routines will be apparent to the skilled person.
  • the sub-routines may be stored together in one executable file to form a self-contained program.
  • Such an executable file may comprise computer-executable instructions, for example, processor instructions and/or interpreter instructions (e.g. Java interpreter instructions).
  • one or more or all of the sub-routines may be stored in at least one external library file and linked with a main program either statically or dynamically, e.g. at run-time.
  • the main program contains at least one call to at least one of the sub-routines.
  • the sub-routines may also comprise function calls to each other.
  • An embodiment relating to a computer program product comprises computer-executable instructions corresponding to each processing stage of at least one of the methods set forth herein. These instructions may be subdivided into sub-routines and/or stored in one or more files that may be linked statically or dynamically.
  • Another embodiment relating to a computer program product comprises computer-executable instructions corresponding to each means of at least one of the systems and/or products set forth herein. These instructions may be subdivided into sub-routines and/or stored in one or more files that may be linked statically or dynamically.
  • the carrier of a computer program may be any entity or device capable of carrying the program.
  • the carrier may include a data storage, such as a ROM, for example, a CD ROM or a semiconductor ROM, or a magnetic recording medium, for example, a hard disk.
  • the carrier may be a transmissible carrier such as an electric or optical signal, which may be conveyed via electric or optical cable or by radio or other means.
  • the carrier may be constituted by such a cable or other device or means.
  • the carrier may be an integrated circuit in which the program is embedded, the integrated circuit being adapted to perform, or used in the performance of, the relevant method.
  • substantially herein, such as in “substantially all emission” or in “substantially consists”, will be understood by the person skilled in the art.
  • the term “substantially” may also include embodiments with “entirely”, “completely”, “all”, etc. Hence, in embodiments the adjective substantially may also be removed.
  • the term “substantially” may also relate to 90% or higher, such as 95% or higher, especially 99% or higher, even more especially 99.5% or higher, including 100%.
  • the term “comprise” includes also embodiments wherein the term “comprises” means “consists of”.
  • the term “functionally” is intended to cover variations in the feature to which it refers, and which variations are such that in the functional use of the feature, possibly in combination with other features it relates to in the invention, that combination of features is able to operate or function. For instance, if an antenna is functionally coupled or functionally connected to a communication device, received electromagnetic signals that are receives by the antenna can be used by the communication device.
  • the word “functionally” as for instance used in “functionally parallel” is used to cover exactly parallel, but also the embodiments that are covered by the word “substantially” explained above.
  • “functionally parallel” relates to embodiments that in operation function as if the parts are for instance parallel. This covers embodiments for which it is clear to a skilled person that it operates within its intended field of use as if it were parallel.
  • the invention further applies to an apparatus or device comprising one or more of the characterising features described in the description and/or shown in the attached drawings.
  • the invention further pertains to a method or process comprising one or more of the characterising features described in the description and/or shown in the attached drawings.

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  • Health & Medical Sciences (AREA)
  • Surgery (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Medical Informatics (AREA)
  • Biomedical Technology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Molecular Biology (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Robotics (AREA)
  • Oral & Maxillofacial Surgery (AREA)
  • Pathology (AREA)
  • Surgical Instruments (AREA)

Abstract

L'invention concerne un dispositif, un procédé et un système pour aider un chirurgien à guider un outil invasif dans le corps d'un patient pendant une opération. Est décrit un dispositif de rétroaction haptique conçu pour faire partie d'un système de guidage pour aider un chirurgien pendant une procédure invasive sur un corps, le dispositif de rétroaction haptique comprenant : des actionneurs haptiques agencés pour avoir un agencement spatial définissant une surface d'interaction haptique, et pour être en communication haptique avec le chirurgien; et un dispositif de commande agencé pour : récupérer des informations sur des emplacements de structures critiques dans une zone du corps; récupérer des informations sur l'agencement spatial des actionneurs haptiques; recevoir un emplacement de pointe d'outil indiquant un emplacement d'une pointe d'outil d'un outil invasif utilisé dans une zone corporelle du corps pendant la procédure invasive dans une direction d'invasion, la pointe d'outil étant conçue pour être poussée vers l'avant dans et/ou latéralement à partir de la direction d'invasion; sélectionner une structure critique la plus proche des structures critiques par rapport à l'emplacement de pointe d'outil; projeter une direction de la structure critique la plus proche sur la surface d'interaction haptique; et actionner un ou plusieurs des actionneurs haptiques sur la base de la projection.
PCT/NL2021/050676 2020-11-11 2021-11-03 Dispositif, procédé et système d'aide au chirurgien pendant une opération WO2022103254A1 (fr)

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NL2026875 2020-11-11
NL2026875A NL2026875B1 (en) 2020-11-11 2020-11-11 Device, method and system for aiding a surgeon while operating

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Cited By (1)

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CN115363752A (zh) * 2022-08-22 2022-11-22 华平祥晟(上海)医疗科技有限公司 智能手术路径指引系统

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US20020120188A1 (en) 2000-12-21 2002-08-29 Brock David L. Medical mapping system
US20150182288A1 (en) 2013-12-31 2015-07-02 Mako Surgical Corp. Systems and methods for implantation of spinal plate
WO2018076094A1 (fr) 2016-10-31 2018-05-03 Synaptive Medical (Barbados) Inc. Système et procédés de navigation 3d
US20190239973A9 (en) 2017-06-22 2019-08-08 NavLab, Inc. Systems and methods of providing assistance to a surgeon for minimizing errors during a surgical procedure
WO2019204611A1 (fr) 2018-04-18 2019-10-24 Arizona Board Of Regents On Behalf Of The University Of Arizona Endoscope à réalité mixte et outils chirurgicaux à rétroaction haptique pour une simulation chirurgicale intégrée visuelle et haptique de réalité virtuelle

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Publication number Priority date Publication date Assignee Title
US20020120188A1 (en) 2000-12-21 2002-08-29 Brock David L. Medical mapping system
US20150182288A1 (en) 2013-12-31 2015-07-02 Mako Surgical Corp. Systems and methods for implantation of spinal plate
WO2018076094A1 (fr) 2016-10-31 2018-05-03 Synaptive Medical (Barbados) Inc. Système et procédés de navigation 3d
US20190239973A9 (en) 2017-06-22 2019-08-08 NavLab, Inc. Systems and methods of providing assistance to a surgeon for minimizing errors during a surgical procedure
WO2019204611A1 (fr) 2018-04-18 2019-10-24 Arizona Board Of Regents On Behalf Of The University Of Arizona Endoscope à réalité mixte et outils chirurgicaux à rétroaction haptique pour une simulation chirurgicale intégrée visuelle et haptique de réalité virtuelle

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* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN115363752A (zh) * 2022-08-22 2022-11-22 华平祥晟(上海)医疗科技有限公司 智能手术路径指引系统

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