Surgical device for imaging an entity

Abstract

A surgical device for imaging at least a portion of an entity, the device comprising: a body portion; a confocal chromatic sensor, CCS, disposed at a first end of the body portion, the CCS configured to determine a distance between the first end and a point on the at least a portion of the entity; and a position tracking system configured to determine and / or track a position in space of one or more parts or a whole of the device; wherein the device is operable to produce a three-dimensional, 3-D, image of at least a portion of the entity based on a plurality of distances obtained from or using the CCS and a plurality of corresponding positions in space obtained from or using the position tracking system. In example methods of imaging an entity using the device, a plurality of distances between the first end and each point of a plurality of points on the entity is determined using the CCS; the position in space of one or more parts or the whole of the device is determined using the position tracking system; and a 3-D image of the entity is generated based on the plurality of distances and the tracking.

Description

[0001] SURGICAL DEVICE FOR IMAGING AN ENTITY

[0002] FIELD

[0003] The present disclosure relates to a surgical device for imaging an entity, particularly but not exclusively for imaging an entity prior to or during surgery, such as arthroscopic surgery. Also disclosed is a method of using said device, a use of said device, a surgical system comprising the device and a processing system, and a computer program product for at least partially implementing the system and / or method.

[0004] BACKGROUND

[0005] Minimally invasive robotic surgery has many benefits over traditional open surgery, including better safety, decreased scarring, faster recovery and shorter hospital stays, which result from less traumatic surgical intervention. Most of these benefits arise from lesser extent of damage to soft tissues surrounding the surgery site and improved accuracy. However, in case of knee arthroplasty, the incision size is defined by the size of the implant, and relatively large (up to 14cm) incisions are still necessary.

[0006] One of the major obstacles in further orthopaedic surgery robotization and reducing invasiveness in image guided treatments is a lack of a reliable and relatively harmless in-surgery registration system. Currently available robotic systems for orthopaedic surgery, utilise pre-surgery computed tomography scans, in-surgery point registration with a contact probe and optical tracking of bone-attached markers or mechanical tracking, which require invasive registration of articular surface landmark points. However, disadvantages of such approach include additional injury due to optical tracker attachment, more invasive procedure, ionising radiation dose during preoperative scanning as well as lower accuracy (linear errors can be up to 1 mm when using the tracker-based navigation systems). In turn, these registration approaches can be more damaging than a relatively moderate misalignment of treatment in knee arthroscopy-based surgeries, such as anterior cruciate ligament reconstruction, autologous chondrocyte transplantation and autologous collagen-induced cartilage repair techniques.

[0007] Touch probe-based imaging techniques, a potential candidate for in-keyhole (and open) surgery navigation technology are currently being used in the medical field. Such techniques may have the potential to serve as a basis for orthopaedic surgical navigation / data acquisition for registration of the anatomy and be relatively harmless avoiding the use of ionising radiation. Nevertheless, touch probe-based scanning has some inherent disadvantages, including bulky designs of both the system and the scanning probe tip as well as probe-imaging object interaction forces which could reduce imaging accuracy and induce damage to the tissue of interest. Improved pre and intra operative imaging techniques are therefore desirable.

[0008] It is therefore an aim of at least one embodiment of at least one aspect of the present disclosure to obviate or at least mitigate at least one of the above identified shortcomings of the prior art.

[0009] SUMMARY

[0010] Various aspects of the present invention are defined in the independent claims. Some preferred features are defined in the dependent claims.

[0011] According to a first aspect of the present disclosure there is provided a surgical device for imaging at least a portion of an entity, the device comprising: a body portion; a confocal chromatic sensor, CCS, disposed at a first end of the body portion, the CCS configured to determine a distance between the first end and a point on the at least a portion of the entity; and a position tracking system configured to determine and / or track a position in space of one or more parts or a whole of the device; wherein the device is operable to produce a three-dimensional, 3-D, image of at least a portion of the entity based on a plurality of distances obtained from or using the CCS and a plurality of corresponding positions in space obtained from or using the position tracking system.

[0012] Advantageously using an optical sensor in the surgical device may provide a noncontact means of producing 3-D images before, during and after surgery which may reduce or eliminate tissue damage (e.g. soft tissue damage) associated with existing contact probe surgical imaging methods. Using a CCS as the optical sensor may allow the surgical device to remain compact whilst still producing accurate and high resolution imaging as may be required before, after and during complex surgical procedures. This may be particularly important for keyhole surgery (e.g. arthroscopy) where it may be desirable to minimise the entry hole, and space at / in the surgical site may be limited.

[0013] By including a position tracking system, depending on the configuration, the position in space of a part or the whole of the device may be determined and / or tracked as the CCS measures the distance between it / the first end of the body portion and the entity. This may allow the position of the CCS / first end to be determined and / or tracked even when a part of the device is obscured from view e.g. when at least the first end of the body portion of the device is within the body during arthroscopic surgery. Combining this positional information with the corresponding determined distance from the CCS may allow an accurate 3-D map, model or image of the entity to be produced.

[0014] As would be appreciated by a skilled person in the field the position tracking system may take a number of different forms. For example, the position tracking system may form part of or be attached to the body portion. Alternatively, the position tracking system may form part of or be attached to the device or system that the body portion may be attached to. In this way the surgical device may be able to use existing positional tracking system reducing the cost and complexity of using the device in a surgical setting.

[0015] It will be appreciated that the surgical device may be used in both ante and post mortem surgical procedures. For example, the surgical device may be used in pre- surgical assessment and / or registration of articular surfaces prior to arthroscopic knee surgery and further used for post-surgical treatment validation. Alternatively, the surgical device may be used in post mortem procedures for investigative, experimental and / or training purposes or the like. The surgical device may be used in open surgery, or partially, fully inside the body during key-hole surgery or other invasive surgical procedures. In general the surgical device may be for, adapted for, or configured for surgery. The surgical device may be for, adapted for, or configured for surgical registration. The device may be used in non-surgical medical and non-medical procedures to produce an accurate 3-D map, model or image of an entity without requiring contact with said entity.

[0016] It will be appreciated that the entity may be a joint or bone e.g. a knee joint or bone, a surface of a joint or bone e.g. an articular surface, or an obscurative element e.g. a muscle, cartilage, membrane, implant or the like at least partially obscuring a joint or bone or surface thereof. The entity may be a tumour, growth, cavity, membrane or the like.

[0017] With the expression “disposed at a first end of the body portion”, it is meant that the element may be located, mounted, fixed or attached on, in or to the body portion at, towards or close to an extremity or peripheral point of the body portion. Where a number of features are defined as being disposed at the same end of the body portion these features may be arranged or configured in any suitable way as would be understood by those skilled in the art.

[0018] The term “confocal chromatic sensor” used in the present disclosure may refer to any suitable polychromatic light sensor and may also be referred to as a “confocal displacement sensor” or “confocal distance sensor”. As would be understood by those skilled in the art a polychromatic light sensor, such as a CCS disperses a beam of white (or visible) light into a spectrum of chromatic light beams which are focused and emitted towards an entity. Any light which is reflected from the entity back towards the sensor may be detected. The reflected light incident on the sensor may then be collected by the sensor, and the intensity and wavelength(s) of the collected light may be analysed on-board or externally (e.g. using a spectrum analyser). Based on this analysis a variety of parameters of a point of the entity may be determined and / or calculated such as displacement, distance, thickness, height, depth, flatness, roughness, profile, radius, porosity and the like.

[0019] The term “image” used in the present disclosure may refer to a plurality of measurement points of a surface of an entity which may be coalesced to form a visual representation of the imaged entity or portion of an entity. The visual representation may be in the form of a mathematical or visual 3-D map, model, image or other suitable representation which may allow the image to be analysed, viewed, manipulated or the like in real-time or following an imaging or surgical procedure.

[0020] It will be understood that the terms “first” and “second” are simply used in the present disclosure to label the relevant elements for the ease of description, and do not necessarily imply any limitations to the sequence or the total number of the relevant elements. The device may comprise or may be comprised in a handheld system.

[0021] Advantageously a handheld system may require less support equipment (e.g. manipulator and associated controls) and may allow the user more direct control over the positioning and movement of the probe across / relative to the entity. A handheld system (i.e. a manual system) held by a user may allow imaging of areas / parts or from orientations which would not be easily accessible by remote operation systems. The imaging process may be more easily adapted in ‘real time’ as the information feedback loop between measurement and control (by the user holding the device) may be reduced or minimised.

[0022] The device may be configured or configurable for mounting or fixing to or on a remote operations system.

[0023] The use of a remote operations system may provide more precise and / or stable control of the surgical device. This may result in more accurate, higher resolution images of the entity which may improve surgical outcomes of complex surgical procedures. By using a remote operations system, potential user fatigue or human error may be eliminated which may allow longer and more complex surgical procedures to be performed where imaging may be required during the procedure.

[0024] The remote operations system may comprise a flexible, articulated and / or bendable device. Said device may be steerable. The remote operations system may comprise at least one motor or actuator for actuating or moving at least one actuating or moving mechanism for steering said device. The remote operations system may be or be integrated into a robotic system, such as a robotic surgical system. The position tracking system may be comprised in or on or be connected to the remote operations system.

[0025] The surgical device may comprise an attachment, mounting or fixing point, plate or position for securely attaching, mounting or fixing the device to the remote operations system. The attachment, mounting or fixing point, plate or position may be articulated, hinged, jointed (e.g. using a ball joint) or the like, such that the device may be manipulated or articulated relative to the remote operations system. The body portion may comprise an elongate portion. The elongate portion may comprise the first end.

[0026] A surgical device comprising an elongate body portion may provide a beneficial means of maximising the distance between the CCS sensor (which may be disposed at one end of the elongate body portion) and connections which may be required for the surgical device and anything attached to, on or in the surgical device, e.g. the remote operations system. This may permit the CCS sensor, disposed at an end of the elongate body portion) to penetrate deeper into the surgical site which may improve the resolution of the produced image and minimise the required size of incision required e.g. in key-hole type surgical procedures.

[0027] The CCS may be configured or configurable to be calibrated to the material composition of the at least a portion of the entity. The CCS may be configured or configurable to be calibrated to the material composition of one or more obscurative elements at least partially obscuring the at least a portion of the entity.

[0028] The entity of which an image is to be produced may be covered, coated or otherwise obscured e.g. by muscle, membrane, intra-articular fluids or the like. By configuring the CCS e.g. by altering the intensity and spectral distribution of the polychromatic light emitted from the CCS, such that the covering, coating or other obscurative element appears substantially transparent to the spectrum of emitted light the entity may be imaged without disturbing or removing the obscurative element, reducing potential damage whilst improving the quality of the produced image. Alternatively, by altering the intensity and spectral distribution of the polychromatic light emitted from the CCS, such that the opacity of the covering, coating or other obscurative element may be increased and a 3-D image of the obscurative element may be produced.

[0029] The CCS may be configured in real time during an imaging / surgical procedure or set to one of a plurality of pre-determined configurations based on the expected obscurative elements and / or the intended aim of the imaging / surgical procedure. This provides a means of quickly and easily changing the configuration of the surgical device to be optimised to image different entities during a single procedure. The device may comprise one or more radiation emitters which may be disposed at the first end. The one or more radiation emitters may be configured to illuminate the entity.

[0030] The radiation emitter(s) may be configured to emit radiation of single peak wavelength, a plurality of peak wavelengths or a broad spectrum of radiation. The radiation emitter(s) may be configured to emit radiation within the visible light spectrum or outside the visible light spectrum (e.g. ultraviolet (UV) or infrared (IR) light).

[0031] A typical CCS may be configured to emit and collect light within the visible light spectrum. By emitting radiation outside the visible light spectrum the entity may be independently illuminated without any potential for interference with the operation of the CCS or other polychromatic light sensor comprised in the surgical device.

[0032] The illuminated entity may be imaged by an imaging device comprised in or on the surgical device or alternatively / additionally by an imaging device external to the surgical device.

[0033] The device may comprise an imaging device which may be disposed at the first end. The imaging device may be configured to collect at least one image of the entity.

[0034] During a surgical procedure one or more radiation emitters and at least one imaging device may be used in combination to capture one or more two-dimensional (2-D) images of the entity or surgical procedure and / or to record and / or provide video of the entity or surgical procedure. This may be used for real time visual feedback during the procedure to enable the user of the surgical device to observe the procedure in more detail and / or to enable the user to direct the surgical device to scan / image a particular portion of the entity. Alternatively, the imaging device may capture one or more images or videos to be reviewed post procedure for training, record keeping purposes or the like.

[0035] The entity may be illuminated by one or more radiation emitters comprised in or on the surgical device or alternatively / additionally by one or more radiation emitters external to the surgical device. By providing the one or more radiation emitters and / or the imaging device at the first end of the body portion of the surgical device the entity may be more fully illuminated and / or the intensity of the radiation emitted by the radiation emitter may be reduced and / or the quality, resolution etc of the captured image(s) or videos may be improved. In particular, during arthroscopy or other key-hole type surgical procedures the surgical space (which may be limited) may be illuminated and / or imaged / observed without requiring an additional element to be introduced through the surgical entry hole further reducing the potential for soft tissue etc. damage during the procedure.

[0036] The device may comprise a surgical tool or instrument disposed, mounted or fixed on, in or to the body portion. The position tracking system may be further configured to determine and / or track a position in space of one or more parts or a whole of the surgical tool or instrument.

[0037] The tool or instrument may be or comprise a medical or surgical device, such as a drill chuck, drill bit and / or drill system, e.g. for drilling or milling a bone, or an electrocautery e.g. for cauterising tissue to mitigate bleeding. The tool or instrument may be replaceable before, after or during a surgical procedure.

[0038] The surgical device may comprise an attachment, mounting or fixing point, plate or position for securely attaching, mounting or fixing the tool or instrument to the device. The attachment, mounting or fixing point, plate or position may be articulated, hinged, jointed (e.g. using a ball joint) or the like, such that the tool may be manipulated or articulated relative to the device.

[0039] When the device is configured or configurable for mounting or fixing to or on a remote operations system comprising at least one motor or actuator, at least one of the motors or actuators may be configured to operate the surgical tool or instrument.

[0040] The combination of a surgical tool or instrument with the monitoring / imaging functionality of the surgical device may free up a hand of the user to operate an additional surgical tool or instrument or free up a connection point of a remote operation system.

[0041] By integrating a surgical tool or instrument into or onto the surgical device the surgical device may be used to direct and / or observe the operation of the surgical tool or device during the procedure. In particular, during arthroscopy or other key-hole type surgical procedures a surgical tool or device may be used in the surgical cavity (which may be limited in space) without requiring an additional element to be introduced through the surgical entry hole further reducing the potential for soft tissue etc. damage during the procedure.

[0042] The device may comprise proofing configured to proof one or more parts or a whole of the device.

[0043] The proofing may be water proofing, particle proofing (e.g. from milled bone particles), acidic or base proofing or the like. The device may be proofed against ingress, damage, wear or the like from bodily and / or surgical fluids such as those that may be encountered in a body, such as internal fluids, e.g. blood, saline etc. The device may have an ingress protection (IP) rating or code. The proofing may comprise a seal, coating or cover in, on or around at least a part or the whole of the device.

[0044] The proofing may comprise a transparent sheath or cover disposed or disposable on an outer surface of part or all of the device.

[0045] The surgical device may comprise or be configured to receive a transparent sheath or cover, which may be disposed or disposable on an outer surface of part or all of the device. The sheath or cover may comprise a biocompatible material. The sheath or cover may be washable. The sheath or cover may be removable and / or replaceable. The sheath or cover may be disposable. The sheath or cover may be transparent to the wavelength(s) of radiation emitted by the CCS and / or the one or more radiation emitters (when present).

[0046] The use of a sheath or cover may proof the surgical device from the surgical environment such that any electronic, or otherwise, elements disposed on or in the body portion do not need additional protection from the surgical environment e.g. from surgical or bodily fluids. Having a sheath or cover transparent to radiation emitted by the CCS and / or the one or more radiation emitters ensures that the elements are protected without degrading performance and / or image quality.

[0047] The transparent sheath or cover may be configured or configurable to be inflated. The sheath or cover may be inflated prior to performing the surgical procedure. The sheath or cover may be inflated after being introduced into the surgical environment e.g. after being inserted in the joint space during arthroplasty. The surgical device may comprise or be connected or connectable to inflation / deflation means to inflate and / or deflate the sheath or cover.

[0048] Advantageously by using an inflatable sheath or cover the outer surface of the sheath or cover may engage the surface of the entity which may reduce the distortion of the image by obscurative elements which may be partially / fully obscuring the entity. The engagement of the sheath or cover on the surface of the entity may also provide a more stable configuration for imaging, improving the quality of the produced 3-D map, model or image.

[0049] The position tracking system may comprise an optical and / or other radiation based position tracking system, such as an Infra-red (IR) based position tracking system. In this way, the position of one or more parts or the whole of the device may be determined using the position tracking system.

[0050] The position tracking system may comprise a plurality of optical tracking markers. The position tracking system may comprise at least one imaging device configured to determine and / or track the position in space of each of plurality of optical tracking markers. The device may comprise, or be configured to communicate with, a processing system. The processing system may be configured to determine and / or track the position in space of the one or more parts or the whole of the device. The determining and / or tracking may at least in part be completed using the determined position in space of the plurality of optical tracking markers.

[0051] Advantageously, as the physical dimensions and characteristics of the device, or of a frame, tool or remote operations system to which the device is mounted or fixed may be known, even if one or more parts of the device comprising one or more optical markers is partially or fully inside the body (e.g. during key-hole surgery), as long as at least one or more of the optical markers is visible to at least one imaging device the position and / or orientation in space of the device may be accurately determined. The plurality of optical tracking markers may be mounted, fixed or attached directly on, in or to the surgical device or alternatively / additionally to a frame which is then mounted, fixed or attached on, in or to the surgical device. The optical tracking markers may be reflective markers, emissive markers or a combination thereof. The tracking markers may be regularly or irregularly shaped and / or sized. The tracking markers may be regularly or irregularly distributed on or in the surgical device and / or frame.

[0052] The processing system may be an on-board processing system. The processing system may be an external processing system and the surgical device may be configured or configurable to communicate the determined position in space of the plurality of optical tracking marker wired or wirelessly to the external processing system.

[0053] The position tracking system may comprise a plurality of rotation or angular sensors for determining a relative angle or orientation between at least two of the plurality of rotation or angular sensors.

[0054] The plurality of rotation or angular sensors may be disposed, mounted or fixed onto one or more flexible, articulated and / or bendable portions of the device or of a frame, tool or remote operations system to which the device is mounted or fixed. The plurality of rotation or angular sensors may be for determining a relative angle or orientation between at least two flexible, articulated and / or bendable portions of the device or of the frame, tool or remote operations system.

[0055] The device may comprise, or be configured to communicate with, a processing system. The processing system may be configured to determine and / or track the position in space of the one or more parts or the whole of the device. The determining and / or tracking may at least in part be completed using the determined relative angle or orientation of the at least two of the plurality of rotation or angular sensors.

[0056] Advantageously, by alternatively / additionally using non optical or radiation based position tracking system an imaging device may not be required for the position tracking system to function and a more accurate position of the surgical device, or a part thereof may be determined. This may further improve the quality of the produce 3- D map, model or image. Furthermore, the relative angle or orientation between rotation or angular sensors can be determined even if a portion of the device which comprises one or more or all of the plurality of rotation or angular sensors is partially or fully inside the body e.g. during key-hole surgery.

[0057] For example, when, as described above, the surgical device is configured or configurable for mounting or fixing to or on a remote operations system, the position and orientation of the surgical device on or in the remote operation system may be determined. Thereinafter the determined relative angle or orientation of the plurality of rotation or angular sensors may be used to determine or track the position in space of the remote operation system. As the position and orientation of the surgical device is known relative to the remote operation system, the same determined positions may be used to accurately determine the position of the surgical device or part thereof.

[0058] The processing system may be an on-board processing system. The processing system may be an external processing system and the surgical device may be configured or configurable to communicate the determined relative angle or orientation of the at least two of the plurality of rotation or angular sensors wired or wirelessly to the external processing system.

[0059] According to a second aspect of the present disclosure there is provided a method of producing a 3-D image of at least a portion of an entity using the surgical device of the first aspect, the method comprising the steps of: determining a plurality of distances between the first end and each point of a plurality of points on the at least a portion of the entity using the CCS; determining and / or tracking the position in space of the one or more parts or the whole of the device using the position tracking system; generating a 3-D image of the at least a portion of the entity based on the plurality of distances determined using the CCS and a plurality of corresponding positions in space determined and / or tracked using the position tracking system.

[0060] The generating of the 3-D image may comprise generating tracking data based on the determining and / or tracking. The generating the 3-D image may comprise generating the 3-D image based on the plurality of distance values and corresponding tracking data. The method may comprise, moving the device relative to the at least a portion of the entity for which an image is to be produced.

[0061] The method may comprise, or be comprised in, a method of contactless pre-operative or in-surgery registration.

[0062] The method may comprise a pre-calibration step. The pre-calibration step may comprise, prior to producing the 3-D image, calibrated the CCS to the material composition of the at least a portion of the entity. The pre-calibration step may comprise, prior to producing the 3-D image, calibrated the CCS to the material composition of one or more obscurative elements at least partially obscuring the at least a portion of the entity.

[0063] According to a third aspect of the present disclosure there is provided a computer program product comprising instructions that, when implemented on a controller or processing system, causes the controller or processing system to control the surgical device of the first aspect to produce a 3-D image of at least a portion of an entity using the second aspect.

[0064] The computer program product may be provided on a carrier-medium, such as a nontransient and / or tangible carrier medium. The computer program product may be programmed or programmable into a processor and / or provided on a memory or storage, such as a RAM, ROM, on a hard drive, on a memory card, USB memory storage, a flash drive or card, and / or the like.

[0065] According to a fourth aspect of the present disclosure there is provided a use of the device of the first aspect to produce a 3-D image of at least a portion of an entity using the second aspect.

[0066] The device may be used for non-contact registration of an articular surface of a knee bone prior to arthroscopic keyhole surgery. The device may be used for registration, imaging, guidance and / or analysis before, during and / or after open or key-hole or other invasive surgical procedures. The device may be used for ante and / or post mortem procedures. The device may be used for non-surgical procedures requiring accurate non-contact 3-D imaging, modelling and / or tracking of at least a portion of an entity.

[0067] According to a fifth aspect of the present disclosure there is provided a surgical system comprising the surgical device of the first aspect and an external processing system configured to implement the computer program product of the third aspect.

[0068] The external processing system may comprise at least one data processing module, such as at least one processor (which may include one or more different types of processor such as one or more of a central processing unit (CPU), Graphics Processing Unit (GPU), maths co-processor, a tensor processing unit, neural processing unit or other type of artificial intelligence (Al) accelerator, a physics processing unit, a field programmable gate array (FPGA), application specific integrated circuit (ASIC), a digital signal processor (DSP), and / or the like. The data processing module may be configured to receive and process the plurality of distances determined using the CCS and the plurality of corresponding positions in space determined and / or tracked using the position tracking system, or data representative thereof, to produce a 3-D map, model or image of at least a portion of the entity. The external processing system may be configured to produce the 3-D map, model or image of at least a portion of the entity by performing one or more of: quantitative analysis, spectral analysis, statistical analysis, application of machine learning or artificial intelligence techniques.

[0069] According to a sixth aspect of the present disclosure there is provided a device for imaging at least a portion of an entity, the device comprising: a body portion; a confocal chromatic sensor, CCS, disposed at a first end of the body portion, the CCS configured to determine a distance between the first end and a point on the at least a portion of the entity; and a position tracking system configured to determine and / or track a position in space of one or more parts or a whole of the device; wherein the device is operable to produce a three-dimensional, 3-D, image of at least a portion of the entity based on a plurality of distances obtained from or using the CCS and a plurality of corresponding positions in space obtained from or using the position tracking system. The device may be a surgical device. The device may be for, adapted for, or configured for surgery. The device may be for, adapted for, or configured for surgical registration.

[0070] The individual features and / or combinations of features defined above in accordance with any aspect of the present invention or below in relation to any specific embodiment of the invention may be utilised, either separately and individually, alone or in combination with any other defined feature, in any other aspect or embodiment of the invention.

[0071] Furthermore, the present invention is intended to cover apparatus configured to perform any feature described herein in relation to a method and / or a method of using, producing, repairing or manufacturing any apparatus feature described herein. For any of the apparatus features described above as performing a function, the present invention also covers a method comprising performing that function.

[0072] BRIEF DESCRIPTION OF THE DRAWINGS

[0073] These and other aspects of the present disclosure will now be described, by way of example only, with reference to the accompanying Figures, in which:

[0074] Figure 1 is a cross-sectional and detailed cross-sectional view of a surgical device according to an example embodiment of the present invention.

[0075] Figure 2 is a planar view of the first end of the surgical device of Figure 1.

[0076] Figure 3 is a schematic illustration of a surgical device according to an example embodiment of the present invention.

[0077] Figure 4 is a schematic illustration of a surgical system comprising a surgical device according to an example embodiment of the present invention.

[0078] Figure 5 is a flowchart of a method of producing a 3-D image of an entity according to an example embodiment of the present disclosure.

[0079] In the Figures, like parts are denoted by like reference numerals. It will be appreciated that the drawings are for illustration purposes only and are not drawn to scale.

[0080] DETAILED DESCRIPTION OF THE DRAWINGS

[0081] Figure 1 shows a cross-sectional and detailed cross-sectional view of a surgical device 100 according to an example embodiment of the present invention. The surgical device 100 is provided only as an example surgical device which may be used to image at least a portion of an entity 1.

[0082] Surgical device 100 comprises a body portion 10 in the form of an elongate partially hollow cylindrical probe member. A confocal chromatic sensor (CCS) 20 is disposed inside the body portion 10 at a first end 15 of the body portion 10, recessed from the surface of the first end 15 as shown in the detailed view A of the first end 15 of the device 100. The body portion 10 comprises an optical cable 22 passing through the centre of the body portion 10. The optical cable comprises at least two optical paths, one to supply white light to the CCS 20 and one to transmit light reflected from the entity 1 and collected by the CCS 20 to be analysed. The white light supplied via the optical cable 22 is dispersed and focused by the CCS 20 into a polychromatic light beam 24 which is emitted from the first end 15 of the body portion 10 towards an entity 1. Any light reflected from the entity 1 and incident on the CCS 20 is collected and transmitted via the optical cable 22 to be analysed to determine a distance between the CCS 20 and / or first end 15 and the entity 1.

[0083] In this example the surgical device 100 is being used for non-contact registration of an articular surface of a knee bone prior to arthroscopic keyhole surgery. However, it will be appreciated that the surgical device 100 may alternatively be used for registration, imaging, guidance, analysis before, during and after open or key-hole or other invasive surgical procedures both ante and post mortem.

[0084] In this example the surgical device 100 is being used to image an unobstructed portion of the entity 1. However, it will be appreciated that the portion of the entity 1 to be imaged may be coated, covered or obscured by an obscurative element 5 e.g. a membrane, cartilage, blood or other bodily fluids or the like. In this case due to the polychromatic nature of the light beam 24 emitted from the CCS 20, the intensity and spectral distribution of light emitted from the CCS 20 can be configured or calibrated such that the obscurative element 5 appears substantially transparent to the light beam 24 improving the accuracy of the 3-D map, model or image created based on the light reflected from the entity 1. Alternatively, the obscurative element 5 may be imaged by altering or calibrating the intensity and spectral distribution of light emitted from the CCS 20 such that the opacity of the obscurative element is increased.

[0085] The surgical device 100 further comprises an attachment means 30 for attaching the body portion 10 to a remote operations system (for example a robotic steerable arm) and / or a position tracking system such as the optical position tracking system 200 of Figure 3 described in more detail below. Examples of suitable remote operations systems and position tracking system thereof are described in WO / 2016 / 198844, the contents of which are incorporated by reference as if set out in full herein.

[0086] The surgical device 100 may be attached to remote operations system and / or position tracking system using a basic quick tool exchange mechanism comprising a threaded screw drive follower and a pushrod attachment with a slit, however alternate suitable attachment mechanisms may be used as will be apparent to one skilled in the art.

[0087] As illustrated in detailed cross-sectional view A of Figure 1, the surgical device 100 further comprises a plurality of radiation emitters 40 and an imaging device 42 disposed at the first end 15. The plurality of radiation emitters 40 and the imaging device 42 are circumferentially disposed around the outer edge of the face of the first end 15 such that they do not obscure or otherwise interfere with the polychromatic light beam 24.

[0088] The body portion 10 comprises a supply cable 44 which supplies power to the plurality of radiation emitters 40 and the imaging device 42 and provides a wired communication means to communicate data to and / or from the imaging device 42. The supply cable 44 enters the body portion 10 through a wall of the body portion 10 passing along the internal surface of the wall of the body portion 10 to the first end 15.

[0089] Figure 2 shows a planar view of the first end 15 of the body portion 10 of surgical device 100 of Figure 1. Sixteen radiation emitters 40 are disposed around the edge of the first end 15. The plurality of radiation emitters 40 are irregularly distributed circumferentially around an outer lens 26 of the CCS 20. In this example the plurality of radiation emitters 40 are all white light LED’s, however it will be appreciated that there may be more or less radiation emitters 40 and the radiation emitter(s) 40 may not all emit the same peak wavelength(s) of radiation e.g. one or some or all of the radiation emitter(s) may emit IR light or UV light or the like.

[0090] An imaging device 42 is further circumferentially disposed between two of the radiation emitters 40. In this example the imaging device 42 is a 1.2mm micro camera, however it will be appreciated that any suitably sized imaging device which can capture the wavelengths of radiation emitted by the radiation emitter(s) may be used e.g. an IR or UV camera or detector.

[0091] Figure 3 shows a schematic illustration of a surgical device, which is or comprises the surgical device 100 of Figure 1 , further comprising a frame 50 of an optical position tracking system securely fixed to attachment means 30 (not shown) and an inflatable transparent sheath 60 disposed over the first end 15 of the body portion 10. In Figure 3, details of the surgical device 100 previously described in relation to Figure 1 have been omitted for clarity reasons.

[0092] The optical position tracking system comprises six optical markers 52 mounted to one planar side of the frame 50. In this example the plurality of optical markers 52 are spherical shaped reflective optical markers, however it will be appreciated that there may be more or less optical markers 52 and one or more or each of the optical markers 52 may alternatively comprise or be radiation emitters. One or more or each of the optical markers 52 may be the same or different sizes or shapes and / or may be disposed on one or both sides of the frame 50. The frame 50 is configured such that the optical markers 52 are disposed at predetermined relative positions to each other and to the body portion 10. At least one tracking device (not shown) is configured to determine and / or track the position in space of each of the plurality of optical markers 52 in addition to the relative position and / or orientation of each of the plurality of optical markers 52 to each other. As the position of each of the optical markers 52 relative to the body portion 10 is known, the position in space of one or more parts or the whole of the surgical device 100 can be determined and / or tracked. In this example, as long as one or more or each of the of the optical markers 52 are visible to the tracking device, as the relative position of the optical markers 52 to the first end 15 is known the position in space of one or more parts or the whole of the surgical device 100 can be determined and / or tracked even when the first end 15 is not visible e.g. when the first end 15 is inserted into the surgical space in a key-hole type surgery.

[0093] Similarly, when the surgical device 100 is additionally / alternatively attached to remote operations system, the position in space of one or more parts or the whole of the surgical device 100 can be determined and / or tracked based on the position and / or orientation of the remote operations system using a non-optical positioning system comprised on or in the remote operations system. In such an example, even if the majority or all of the body portion 10 of the surgical device 100 is inserted into the surgical space, as the position of the body portion 10 relative to the remote operations system is known the position in space of one or more parts or the whole of the surgical device 100 can still be determined and / or tracked

[0094] The inflatable transparent sheath 60 of Figure 3 is a latex rubber sheath however any suitable biocompatible material may be used e.g. silicone based materials. In this example the sheath 60 is secured to the body portion 10 of the surgical device 100 by a semi-permanent biocompatible adhesive, however it will be appreciated that the sheath 60 may be secured by any suitable means e.g. friction fit, mechanical clamping force. In this example the sheath 60 is selectively inflatable using a compressed air supply (not shown) disposed on or in the body portion 10 allowing the sheath to be inflated after insertion into the body e.g. into a joint space during arthroscopy, however it will be appreciated that the sheath may be pre-inflated prior to use, or may alternatively / additionally be constructed from a rigid material e.g. for open surgical procedures.

[0095] Figure 4 illustrates an example surgical system 1000 according to an example embodiment of the present invention comprising a surgical device 1100 which is or may comprise surgical device 100 of Figure 1. The surgical system 1000 comprises a single surgical device 1100 comprised in a handheld system and comprising an optical position tracking system and inflatable transparent sheath, an example of which is illustrated in Figure 3. However, it will be appreciated that the surgical system 1000 may comprise more than one surgical device 1100 and / or one or more or each of the surgical device(s) 1100 may comprise handheld systems or be mounted or fixed to a remote operations system.

[0096] The surgical system 1000 further comprises an external processing system 1200 configured to process data communicated from the surgical device 1100. The data may be representative of the plurality of distances obtained from or using the CCS and / or the plurality of corresponding positions in space obtained from or using the position tracking system. The surgical system 1000 further comprises external data storage 1300 configured to store the data communicated from the surgical device 1100, output data from / to the external processing system 1200, store the produced map, image or model and / or the like. The surgical system 1000 further comprises I / O devices 1400 which may be used to display a status of the imaging process, direct the user of the surgical device, display the fully / partially completed map, model or image, display the captured images and / or video from the imaging devices (when present) and / or allow input from a user to control the imaging process e.g. the wavelength and / or intensity of the radiation emitters (when present) or the steering of the remote operations system (when present).

[0097] In some examples, neural networks or artificial intelligence techniques such as deep learning can be used to produce the map, model or image. In these cases, training data can be used to train the neural network to correctly produce the map, model or image (as an output of the neural network) from the plurality of distances obtained from or using the CCS and the plurality of corresponding positions in space obtained from or using the position tracking system (as an input of the neural network). Examples of training data include data from historical measurements or from models or simulation.

[0098] Although a number of example devices and systems have been described as set forth above, it should be understood that these examples are illustrative only and that the invention is not limited to these examples. Those skilled in the art will be able to make modifications and alternatives in view of the disclosure which are contemplated as falling within the scope of appended claims. For example, the CCS, radiation emitters and imaging device disposed at the first end of the body portion of the surgical device may be suitably sealed or individually protected from the surgical environment such that the sheath is no longer required. This frees up space within the surgical space (e.g. during key-hole type surgery) for other surgical tools or instruments, allowing the surgical device to be used as an intra operative imaging device.

[0099] Figure 5 is a flowchart summarizing a method 2000 of producing a 3-D image of at least a portion of an entity using a surgical device and / or surgical system as described throughout this disclosure. The method comprises at step S2100 determining a plurality of distances to each point of a plurality of points on the entity, or part thereof, to be imaged using a CCS sensor comprised in the first end of the body portion of the surgical device. This may be achieved by scanning the first end across the relevant surface of the entity.

[0100] At step S2200 the position in space of the surgical device is tracked using the position tracking system of the surgical device. It will be appreciated that the tracking of the position in space and determining of the distance(s) shall be carried out substantially simultaneously such that a position in space is determined for each corresponding distance determination. This may be achieved by optically tracking optical markers on an optical position tracking system as described above in reference to Figure 3. Alternatively, the surgical device may be secure to a remote operations system comprising an optical or non-radiation based position tracking system.

[0101] At step S2300 a 3-D image of the entity is generated, e.g. by the external processing system 1200 illustrated in Figure 4. The 3-D image is generated based on the plurality of distances determined using the CCS and a plurality of corresponding positions in space determined and / or tracked using the position tracking system. The 3-D image may be displayed to the user, stored for later use or communicated to a remote location (e.g. a different room or work station or the like) for viewing in real-time or for later use.

[0102] The above detailed description of the drawings is provided in order to give an example of how the concepts described herein may be implemented. However, the scope of protection is defined by the claims and alternatives to the specific examples provided above will be apparent to a person skilled in the art and falling within the scope of the claims are intended to fall within the scope of the present disclosure.

Claims

CLAIMS:

1. A surgical device for imaging at least a portion of an entity, the device comprising: a body portion; a confocal chromatic sensor, CCS, disposed at a first end of the body portion, the CCS configured to determine a distance between the first end and a point on the at least a portion of the entity; and a position tracking system configured to determine and / or track a position in space of one or more parts or a whole of the device; wherein the device is operable to produce a three-dimensional, 3-D, image of at least a portion of the entity based on a plurality of distances obtained from or using the CCS and a plurality of corresponding positions in space obtained from or using the position tracking system.

2. The surgical device of claim 1, wherein the device is, comprises or is comprised in a handheld system.

3. The surgical device of claim 1, wherein the device is configured or configurable for mounting or fixing to or on a remote operations system.

4. The surgical device of any preceding claim wherein the body portion comprises an elongate portion, and the elongate portion comprises the first end.

5. The surgical device of any preceding claim, wherein the CCS is configured or configurable to be calibrated to the material composition of the at least a portion of the entity or to the material composition of one or more obscurative elements at least partially obscuring the at least a portion of the entity.

6. The surgical device of any preceding claim wherein the device further comprises one or more radiation emitters disposed at the first end, the one or more radiation emitters configured to illuminate the entity.

7. The surgical device of any preceding claim wherein the device further comprises an imaging device disposed at the first end, the imaging device configured to collect at least one image of the entity.

8. The surgical device of any preceding claim wherein the device further comprises a surgical tool or instrument disposed, mounted or fixed on, in or to the body portion, and optionally wherein the position tracking system is further configured to determine and / or track a position in space of one or more parts or a whole of the surgical tool or instrument.

9. The surgical device of any preceding claim, further comprising proofing configured to proof one or more parts or a whole of the device.10 The surgical device of claim 9 wherein the proofing comprises a transparent sheath or cover disposed or disposable on an outer surface of part or all of the device.

11. The surgical device of claim 10, wherein the transparent sheath or cover is configured or configurable to be inflated.

12. The surgical device of any preceding claim, wherein the position tracking system comprises an optical or other radiation based position tracking system.

13. The surgical device of any preceding claim, wherein: the position tracking system comprises a plurality of optical tracking markers and at least one imaging device configured to determine and / or track the position in space of each of plurality of optical tracking markers; and the surgical device comprises, or is configured to communicate with, a processing system, the processing system being configured to determine and / or track the position in space of the one or more parts or the whole of the device at least in part using the determined position in space of the plurality of optical tracking markers.

14. The surgical device of any preceding claim, wherein: the position tracking system comprises a plurality of rotation or angular sensors for determining a relative angle or orientation between at least two of the plurality of rotation or angular sensors; and the surgical device comprises, or is configured to communicate with, a processing system, the processing system being configured to determineand / or track the position in space of the one or more parts or the whole of the device at least in part using the determined relative angle or orientation of the at least two of the plurality of rotation or angular sensors.

15. A method of producing a 3-D image of at least a portion of an entity using the surgical device of claim 1, the method comprising the steps of: determining a plurality of distances between the first end and each point of a plurality of points on the at least a portion of the entity using the CCS; determining and / or tracking the position in space of the one or more parts or the whole of the device using the position tracking system; generating a 3-D image of the at least a portion of the entity based on the plurality of distances determined using the CCS and a plurality of corresponding positions in space determined and / or tracked using the position tracking system.

16. The method of claim 15 wherein generating the 3-D image comprises the steps of: generating tracking data based on the determining and / or tracking; and generating the 3-D image based on the plurality of distance values and the corresponding tracking data.

17. The method of claim 15 or claim 16 further comprising, moving the device relative to the at least a portion of the entity for which an image is to be produced.

18. The method of any one of claims 15 to 17 wherein the method comprises or is comprised in a method of contactless pre-operative or in-surgery registration.

19. The method of any one of claims 15 to 18 wherein the method comprises a precalibration step, wherein prior to producing the 3-D image the CCS is calibrated to the material composition of the at least a portion of the entity or to the material composition of one or more obscurative elements at least partially obscuring the at least a portion of the entity.

20. A computer program product comprising instructions that, when implemented on a controller or processing system, causes the controller or processing system to controlthe surgical device of claim 1 to produce a 3-D image of at least a portion of an entity using the method of claim 15.

21. A use of the surgical device of claim 1 to produce a 3-D image of at least a portion of an entity using the method of claim 15.

22. A surgical system comprising the surgical device of claim 1 and an external processing system configured to implement the computer program product of claim 20.

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